US20060173545A1 - Spinal disc annulus reconstruction method and deformable spinal disc annulus stent - Google Patents

Spinal disc annulus reconstruction method and deformable spinal disc annulus stent Download PDF

Info

Publication number
US20060173545A1
US20060173545A1 US11/386,616 US38661606A US2006173545A1 US 20060173545 A1 US20060173545 A1 US 20060173545A1 US 38661606 A US38661606 A US 38661606A US 2006173545 A1 US2006173545 A1 US 2006173545A1
Authority
US
United States
Prior art keywords
annulus
patch
stent
aperture
disc
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/386,616
Inventor
Joseph Cauthen
Matthew Burns
Lawrence Wales
Brian Dukart
Bradley Wessman
Rodney Houfburg
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Anulex Technologies Inc
Original Assignee
Anulex Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/947,078 external-priority patent/US6592625B2/en
Priority claimed from US10/075,615 external-priority patent/US20020123807A1/en
Priority claimed from US10/133,339 external-priority patent/US7052516B2/en
Application filed by Anulex Technologies Inc filed Critical Anulex Technologies Inc
Priority to US11/386,616 priority Critical patent/US20060173545A1/en
Publication of US20060173545A1 publication Critical patent/US20060173545A1/en
Assigned to ANULEX TECHNOLOGIES, INC. reassignment ANULEX TECHNOLOGIES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PROTOSTAR, INC.
Assigned to ANULEX TECHNOLOGIES, INC. reassignment ANULEX TECHNOLOGIES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CAUTHEN, JOSEPH C., III, HOUFBURG, RODNEY L., WALES, LAWRENCE W., BURNS, MATTHEW M., DUKART, BRIAN L., WESSMAN, BRADLEY J.
Assigned to CAUTHEN RESEARCH GROUP, INC. reassignment CAUTHEN RESEARCH GROUP, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CAUTHEN, JOSEPH C.
Assigned to PROTOSTAR, INC. reassignment PROTOSTAR, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CAUTHEN RESEARCH GROUP
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0642Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166Sutures
    • A61B2017/06176Sutures with protrusions, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A61B2017/0648Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks threaded, e.g. tacks with a screw thread
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907Nets or sleeves applied to surface of prostheses or in cement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2817Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30092Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/3011Cross-sections or two-dimensional shapes
    • A61F2002/30138Convex polygonal shapes
    • A61F2002/30158Convex polygonal shapes trapezoidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30299Three-dimensional shapes umbrella-shaped or mushroom-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30579Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30777Oblong apertures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2002/4435Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2002/444Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017Angular shapes
    • A61F2230/0026Angular shapes trapezoidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0093Umbrella-shaped, e.g. mushroom-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys

Definitions

  • the invention generally relates to methods and implantable medical devices for the closure, sealing, and/or repair of an aperture in the intervertebral disc annulus.
  • aperture refers to a hole in the annulus that is a result of a surgical incision into the intervertebral disc annulus, or the consequence of a naturally occurring tear (rent).
  • the invention generally relates to surgical devices and methods for intervertebral disc wall repair or reconstruction.
  • the invention further relates to an annular repair device, or stent, for annular disc repair. These stents can be of natural or synthetic materials.
  • the effects of said reconstruction are restoration of disc wall integrity and reduction of the failure rate (3-21%) of a common surgical procedure (disc fragment removal or discectomy). This surgical procedure is performed about 390,000 times annually in the United States.
  • the spinal column is formed from a number of bony vertebrae, which in their normal state are separated from each other by intervertebral discs. These discs are comprised of the annulus fibrosus, and the nucleus pulposus, both of which are soft tissue.
  • the intervertebral disc acts in the spine as a crucial stabilizer, and as a mechanism for force distribution between adjacent vertebral bodies. Without the disc, collapse of the intervertebral space occurs in conjunction with abnormal joint mechanics and premature development of arthritic changes.
  • the normal intervertebral disc has an outer ligamentous ring called the annulus surrounding the nucleus pulposus.
  • the annulus binds the adjacent vertebrae together and is constituted of collagen fibers that are attached to the vertebrae and cross each other so that half of the individual fibers will tighten as the vertebrae are rotated in either direction, thus resisting twisting or torsional motion.
  • the nucleus pulposus is constituted of loose tissue, having about 85% water content, which moves about during bending from front to back and from side to side.
  • the aging process contributes to gradual changes in the intervertebral discs.
  • the annulus loses much of its flexibility and resilience, becoming more dense and solid in composition.
  • the aging annulus may also be marked by the appearance or propagation of cracks or fissures in the annular wall.
  • the nucleus desiccates, increasing viscosity and thus losing its fluidity.
  • these features of the aged intervertebral discs result in less dynamic stress distribution because of the more viscous nucleus pulposus, and less ability to withstand localized stresses by the annulus fibrosus due to its desiccation, loss of flexibility, and the presence of fissures. Fissures can also occur due to disease or other pathological conditions.
  • nucleus pulposus is urged outwardly from the subannular space through a rent, often into the spinal column. Extruded nucleus pulposus can, and often does, mechanically press on the spinal cord or spinal nerve rootlet. This painful condition is clinically referred to as a ruptured or herniated disc.
  • the subannular nucleus pulposus migrates along the path of least resistance forcing the fissure to open further, allowing migration of the nucleus pulposus through the wall of the disc, with resultant nerve compression and leakage of chemicals of inflammation into the space around the adjacent nerve roots supplying the extremities, bladder, bowel, and genitalia.
  • the usual effect of nerve compression and inflammation is intolerable back or neck pain, radiating into the extremities, with accompanying numbness, weakness, and in late stages, paralysis and muscle atrophy, and/or bladder and bowel incontinence.
  • injury, disease, or other degenerative disorders may cause one or more of the intervertebral discs to shrink, collapse, deteriorate, or become displaced, herniated, or otherwise damaged and compromised.
  • thermal annuloplasty involving the heating of sub-annular zones in the non-herniated painful disc, seeking pain relief, but making no claim of reconstruction of the ruptured, discontinuous annulus wall.
  • the repair of a damaged intervertebral disc might include the augmentation of the nucleus pulposus, and various efforts at nucleus pulposus replacement have been reported.
  • the present invention is directed at the repair of the annulus, whether or not a nuclear augmentation is also warranted.
  • the present invention provides methods and related materials for reconstruction of the disc wall in cases of displaced, herniated, ruptured, or otherwise damaged intervertebral discs.
  • a method for intervertebral disc reconstruction for treating a disc having an aperture in the wall of the annulus fibrosis, wherein the aperture provides a path for the migration of nucleus pulposus from the subannular space, the method including the steps of providing an expandable patch having a first configuration dimensioned to pass through the aperture and a second expanded configuration having at least one dimension at least as large as the aperture and having at least one dimension larger than a corresponding dimension in said first configuration; inserting the patch through the aperture into the subannular space when the device is in the first collapsed configuration; and causing or allowing the patch to expand in the subannular space into the second expanded configuration to bridge the aperture, thereby occluding the aperture and preventing the migration of nucleus pulposus therethrough.
  • the implantable medical device is placed, positioned, and affixed to the annulus to reduce re-extrusion of the nucleus through the aperture by: acting as a mechanical barrier; restoring the natural integrity of the wall of the annulus; and promoting the healing of the annulus through the reapproximation of disc wall tissue.
  • Increased integrity and faster and/or more thorough healing of the aperture is intended to reduce future recurrence of herniation of the disc nucleus from the intervertebral disc, and the recurrence of resulting back pain.
  • the repair of the aperture could promote enhanced biomechanics and reduce the possibility of intervertebral disc height collapse and segmental instability, thus resulting in a decrease in the recurrence of back pain after a surgical procedure.
  • the repair of the aperture with the reduction of the re-extrusion of the nucleus may also advantageously reduce adhesion formation surrounding the nerve roots.
  • the nuclear material of the disc is toxic to the nerves and is believed to cause increased inflammation surrounding the nerves, which in turn can cause increased scar formation (adhesions or epidural fibrosis) upon healing. Adhesions created around the nerve roots can cause continued back pain. Any reduction in adhesion formation is believed to reduce future recurrence of pain.
  • One of the objects of the present inventions is to act as a mechanical barrier to the extrusion of the nucleus from the disc space, add mechanical integrity to the annulus and the tissue surrounding the aperture, and to promote faster and a more complete healing of the aperture.
  • the device could be used in other procedures that involve incisions into the annulus of the intervertebral disc.
  • a surgical procedure such as discectomy (a surgical procedure performed to remove herniated fragments of the disc nucleus)
  • the device could be used in other procedures that involve incisions into the annulus of the intervertebral disc.
  • An example of another procedure that could require a repair technique involves the replacement of the nucleus—nucleus replacement—with an implantable nucleus to replace the functioning of the natural nucleus when it is degenerated.
  • the object of the invention in this case would be similar in that the repair would maintain the replacement nucleus within the disc space.
  • a sub-annular patch/stent can be employed to repair an intervertebral disc annulus.
  • the repair of the annulus involves the placement and fixation of a fascial autograft patch to the sub-annular space which can additionally employ two or more sutures, while re-approximating the tissues surrounding the aperture.
  • the invention through involvement of the sub-annular space and wall for the repair of the aperture, has several advantages over the prior art; for example, sealing the aperture only on the outer surface, or sealing the aperture only within the aperture.
  • the first advantage of a repair that involves the sub-annular surface derives itself from the physical nature of a circular (or an elliptical) compressed chamber with a radius, like an intervertebral disc. Sealing the inside wall has the inherent advantage of being at a smaller radius of curvature versus the outer wall and thus, according to LaPlace's Law, the patch would be subjected to lower stresses at any given pressure, all else held equal.
  • Another advantage of utilizing the inner surface to accomplish sealing is that the natural pressure within the disc can enhance the sealing of the device against the inner wall of the disc space. Conversely, if the repair is performed on the outer surface of the annulus there is an inherent risk of leakage around the periphery of the device, with the constant exposure to the pressure of the disc.
  • Another advantage of the present invention over the prior art in utilizing the inner surface of the annulus is the reduction of the risk of having a portion of the device protruding from the exterior surface of the annulus.
  • Device materials protruding from the exterior of the annulus pose a risk of damaging the nerve root and/or spinal canal which are in close proximity. Damage to these structures can result in continued pain, incontinence, bowel dysfunction, and paralysis.
  • the present invention also incorporates the concept of pulling the tissues together that surround the aperture, the inner surface, and the outer surface of the annulus to help increase the integrity of the repair.
  • An aperture is created measuring approximately, for example, 6 mm ⁇ 2 mm in the wall of the annulus after performing a discectomy procedure in which a portion of the nucleus is also removed from the disc space, as shown in FIGS. 32 a , 32 b , 33 a and 33 b.
  • Two or more sutures are passed through the upper and lower surfaces of the aperture and they are pushed within the intervertebral disc space to create a “sling” to receive the fascial autograft as shown for example in FIG. 34 .
  • a piece of para-spinal fascial tissue is removed from the patient measuring approximately, for example, 10 mm ⁇ 5 mm.
  • the autograft is folded and compressed to pass through the aperture in the annulus, as shown for example in FIG. 35 .
  • the autograft takes a second shape, within the annulus that is uncompressed and oriented to be in proximity of the subannular wall of the annulus, within the sling, as shown for example in FIG. 36 .
  • the autograft may be inserted entirely into the subannular space, or a portion may extend into the rent as depicted in FIG. 36 .
  • the sutures are tightened, as shown for example in FIG. 37 , thus tightening the sling surrounding the autograft, to bring the autograft in close proximity with the subannular wall, while providing tension to bring the patch at the subannular surface together with the outer surface of the annular wall, thus creating increased integrity of the annulus surrounding the aperture, as well as causing the autograft to take a second shape that is larger than the aperture. Furthermore, the tightening, and eventual tying of the sutures also promotes the re-approximation of the tissue at the outer surface of the annulus and within the aperture.
  • the sutures are tied and the ends of the sutures are cut.
  • a piece of autograft fat tissue may be placed over the discectomy site for the prevention of adhesion formation, a typical surgical technique.
  • Standard surgical techniques are utilized to close the access site of the surgical procedures.
  • an expandable patch/stent (note: patch, stent and device are used interchangeably) that has, in use, at least a portion of the device in proximity to the sub-annular space of the intervertebral disc annulus; a means to affix the patch to stay in proximity with the annulus; a means to draw the patch and the annular tissue together and fasten in tension; and a means to help reduce the relative motion of the surfaces of the aperture after fixation, and thus promote healing.
  • close approximation of tissue, while reducing the motion of the surfaces provides the optimal environment for healing.
  • one or more mild biodegradable surgical sutures can be placed at about equal distances along the sides of a pathologic aperture in the ruptured disc wall (annulus) or along the sides of a surgical incision in the annular wall, which may be weakened or thinned.
  • Sutures are then tied in such fashion as to draw together the sides of the aperture, effecting reapproximation or closure of the opening, to enhance natural healing and subsequent reconstruction by natural tissue (fibroblasts) crossing the now surgically narrowed gap in the disc annulus.
  • the method can be augmented by creating a subannular barrier in and across the aperture by placement of a patch of human muscle fascia (muscle connective tissue) or any other autograft, allograft, or xenograft acting as a bridge or a scaffold, providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus, prior to closure of the aperture.
  • a patch of human muscle fascia muscle connective tissue
  • any other autograft, allograft, or xenograft acting as a bridge or a scaffold, providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus, prior to closure of the aperture.
  • a braided patch can be formed having a first collapsed configuration having a major longitudinal dimension with first and second ends. When these ends are moved toward each other along the longitudinal axis, a portion of the device between the ends can deploy outwardly to form an expanded configuration.
  • biocompatible membranes can be employed as a bridge, stent, patch or barrier to subsequent migration of the disc nucleus through the aperture.
  • biocompatible materials may be, for example, medical grade biocompatible fabrics, biodegradable polymeric sheets, or form fitting or non-form fitting fillers for the cavity created by removal of a portion of the disc nucleus pulposus in the course of the disc fragment removal or discectomy.
  • the prosthetic material can be placed in and around the intervertebral space, created by removal of the degenerated disc fragments.
  • FIG. 1 shows a perspective view of an illustrative embodiment of an annulus stent.
  • FIG. 2 shows a front view of the annulus stent of FIG. 1 .
  • FIG. 3 shows a side view of the annulus stent of FIG. 1 .
  • FIGS. 4A-4C show a front view of alternative illustrative embodiments of an annulus stent.
  • FIGS. 5A-5B show the alternative embodiment of a further illustrative embodiment of an annulus stent.
  • FIGS. 6A-6B show the alternative embodiment of a further illustrative embodiment of an annulus stent.
  • FIG. 7 shows a primary closure of an opening in the disc annulus.
  • FIGS. 8A-8B show a primary closure with a stent.
  • FIG. 9 shows a method of suturing an annulus stent into the disc annulus utilizing fixation points on vertebral bodies.
  • FIGS. 10A-10B show a further illustrative embodiment of an annulus stent with flexible bladder being expanded into the disc annulus.
  • FIGS. 11A-11D show an annulus stent being inserted into and expanded within the disc annulus.
  • FIGS. 12A-12B show an annulus stent with a flexible bladder being expanded.
  • FIG. 13 shows a perspective view of a further illustrative embodiment of an annulus stent.
  • FIG. 14 shows a first collapsed view of the annulus stent of FIG. 13 .
  • FIG. 15 shows a second collapsed view of the annulus stent of FIG. 13 .
  • FIGS. 16A-16C show the annulus stent of FIG. 13 being inserted into the disc annulus.
  • FIGS. 17A-17C show a method of inserting the annulus stent of FIG. 13 into the disc annulus.
  • FIGS. 18A-18B show a further illustrative embodiment of an annulus stent with a flexible bladder.
  • FIGS. 19A-19B show another illustrative embodiment of an annulus stent with a flexible bladder.
  • FIG. 20 shows an expanded annulus stent with barbs on the radial extension.
  • FIG. 21 shows a still further illustrative embodiment of an annulus stent with a compressible core.
  • FIG. 22 shows a still further illustrative embodiment of an introduction device for an annulus stent.
  • FIG. 23 shows a modification of the device depicted in FIG. 22 .
  • FIG. 24 shows an exemplary introduction tool for use with the devices of FIGS. 22 and 23 with a stent deflected proximally.
  • FIG. 25 shows an exemplary introduction tool for use with the devices of FIGS. 22 and 23 with a stent deflected distally.
  • FIG. 26 shows an exemplary introduction tool for use with the devices of FIGS. 22 and 23 with a stent deflected partially distally and partially proximally.
  • FIG. 27 shows a still further illustrative embodiment of a stent device having a grasping feature and fixation devices in the form of barbs.
  • FIG. 28 shows the illustrative embodiment in FIG. 27 deployed subannularly.
  • FIG. 29 shows a still further illustrative embodiment of an annulus stent employing a secondary barbed fixation device.
  • FIG. 30 shows a still further illustrative embodiment of an annulus stent employing another example of a secondary barbed fixation device.
  • FIG. 31 shows the frame of a still further illustrative embodiment of an annulus stent having a metal substrate being machined from flat stock.
  • FIG. 32 a shows a herniated disc in perspective view
  • FIG. 32 b shows the same disc after discectomy.
  • FIG. 33 a shows a top view of the disc post-discectomy
  • FIG. 33 b shows a posteriolateral view of the disk showing an incision.
  • FIG. 34 shows schematically the creation of a subannular sling using sutures.
  • FIG. 35 schematically shows the introduction of a compressed autograft stent/patch into the subannular space.
  • FIG. 36 schematically shows the autograft of FIG. 35 in an expanded shape within the annulus.
  • FIG. 37 schematically shows the tightening of the sutures to reapproximate the annulus aperture and draw the stent/patch of FIG. 35 toward the annular wall.
  • FIG. 38 shows an exemplary collar for use in repairing a disc annulus.
  • FIG. 39 schematically depicts the collar of FIG. 38 in use for disc annulus repair.
  • FIG. 40 shows a still further exemplary embodiment of the present invention using a bag to contain the patch/stent.
  • FIG. 41 a - e show still further illustrative embodiments of the present invention having frames.
  • FIG. 42 shows an illustrative method for placing a barbed expandable patch in the subannular disc space.
  • FIG. 43 shows the patch of FIG. 42 being fixed to the inside wall of the annulus fibrosus.
  • FIGS. 44 a - g show a still further illustrative embodiment of an introduced and expanded annulus stent/patch being fixated and the aperture reapproximated.
  • FIGS. 45 a - c schematically depict a still further embodiment of the present invention where an expandable stent/patch is tethered in situ using a cinch line.
  • FIGS. 46 a - c schematically depict the cinch line of FIG. 45 being fixated through use of a surgical staple device.
  • FIGS. 47 a - b show an illustrative embodiment of a suturing arrangement for securing a patch/stent in the annulus.
  • FIG. 48 a - b depict a still further illustrative embodiment where fixation sutures are placed into the vertebral body or the Sharpey fibers.
  • FIGS. 49 a - c schematically depict a still further embodiment of the present invention where an expandable stent/patch is tethered in situ using a cinch line.
  • FIGS. 50 a - c schematically depict the cinch line of FIG. 49 being fixated through use of a barbed surgical staple device that penetrates the patch/stent.
  • FIG. 51 depicts an exemplary use of filler tissue within the aperture during placement of a patch/stent tethered by a cinch line.
  • FIGS. 52 a - e shows exemplary embodiments of various additional patch/stent fixation techniques.
  • FIG. 53 shows a still further illustrative embodiment of a stent/patch having a frame.
  • FIG. 54 a - f shows a still further illustrative embodiment of an annular stent/patch having a self-contained fixation tightening feature.
  • FIG. 55 shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 56 a - c shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 57 a - c shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 58 shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 59 shows a still further exemplary embodiment of the present invention having a springing arrangement.
  • FIG. 60 shows a lateral view of a still further exemplary embodiment of the present invention having a braided arrangement in a collapsed configuration.
  • FIG. 61 shows an axial view of the exemplary embodiment of FIG. 60 in an expanded configuration.
  • FIG. 62 shows a lateral view of the exemplary embodiment of FIG. 60 in a collapsed configuration mounted on an illustrative delivery device.
  • FIG. 63 shows a lateral cutaway view of the exemplary embodiment of FIG. 60 in a collapsed configuration.
  • FIG. 64 shows a lateral cutaway view of the exemplary embodiment of FIG. 60 in an expanded configuration.
  • FIG. 65 shows a lateral view of an illustrative delivery member as shown in the exemplary embodiment of FIGS. 63 and 64 .
  • FIG. 66 shows a lateral view of an exemplary embodiment of the invention in an expanded configuration subannularly.
  • a damaged annulus 42 is repaired by use of surgical sutures 40 .
  • One or more surgical sutures 40 are placed at about equal distances along the sides of a pathologic aperture 44 in the annulus 42 .
  • Reapproximation or closure of the aperture 44 is accomplished by tying the sutures 40 so that the sides of the aperture 44 are drawn together.
  • the reapproximation or closure of the aperture 44 enhances the natural healing and subsequent reconstruction by the natural tissue (e.g., fibroblasts) crossing the now surgically narrowed gap in the annulus 42 .
  • the surgical sutures 40 are biodegradable, but permanent non-biodegradable may be utilized.
  • a surgical incision can be made along the weakened or thinned region of the annulus 42 and one or more surgical sutures 40 can be placed at about equal distances laterally from the incision. Reapproximation or closure of the incision is accomplished by tying the sutures 40 so that the sides of the incision are drawn together. The reapproximation or closure of the incision enhances the natural healing and subsequent reconstruction by the natural tissue crossing the now surgically narrowed gap in the annulus 42 .
  • the surgical sutures 40 are biodegradable, but permanent non-biodegradable materials may be utilized.
  • the method can be augmented by the placement of a patch of human muscle fascia or any other autograft, allograft or xenograft in and across the aperture 44 .
  • the patch acts as a bridge in and across the aperture 44 , providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus 42 , prior to closure of the aperture 44 .
  • a biocompatible membrane can be employed as an annulus stent 10 , being placed in and across the aperture 44 .
  • the annulus stent 10 acts as a bridge in and across the aperture 44 , providing a platform for a traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus 42 , prior to closure of the aperture 44 .
  • the device, stent or patch can act as a scaffold to assist in tissue growth that healingly scars the annulus.
  • the annulus stent 10 comprises a centralized vertical extension 12 , with an upper section 14 and a lower section 16 .
  • the centralized vertical extension 12 can be trapezoid in shape through the width and may be from about 8 mm-12 mm in length.
  • the upper section 14 of the centralized vertical extension 12 may be any number of different shapes, as shown in FIGS. 4A through 4C , with the sides of the upper section 14 being curved or with the upper section 14 being circular in shape.
  • the annulus stent 10 may contain a recess between the upper section 14 and the lower section 16 , enabling the annulus stent 10 to form a compatible fit with the edges of the aperture 44 .
  • the upper section 14 of the centralized vertical extension 12 can comprise a slot 18 , where the slot 18 forms an orifice through the upper section 14 .
  • the slot 18 is positioned within the upper section 14 such that it traverses the upper section's 14 longitudinal axis.
  • the slot 18 is of such a size and shape that sutures, tension bands, staples or any other type of fixation device known in the art may be passed through, to affix the annulus stent 10 to the disc annulus 42 .
  • the upper section 14 of the centralized vertical extension 12 may be perforated.
  • the perforated upper section 14 contains a plurality of holes that traverse the longitudinal axis of upper section 14 .
  • the perforations are of such a size and shape that sutures, tension bands, staples or any other type of fixation device known in the art may be passed through, to affix the annulus stent 10 to the disc annulus 42 .
  • the lower section 16 of the centralized vertical extension 12 can comprise a pair of lateral extensions, a left lateral extension 20 and a right lateral extension 22 .
  • the lateral extensions 20 and 22 comprise an inside edge 24 , an outside edge 26 , an upper surface 28 , and a lower surface 30 .
  • the lateral extensions 20 and 22 can have an essentially constant thickness throughout.
  • the inside edge 24 is attached to and is about the same length as the lower section 16 .
  • the outside edge 26 can be about 8 mm-16 mm in length.
  • the inside edge 24 and the lower section 16 meet to form a horizontal plane, essentially perpendicular to the centralized vertical extension 12 .
  • the upper surface 28 of the lateral extensions 20 and 22 can form an angle from about 0°-60° below the horizontal plane.
  • the width of the annulus stent 10 may be from about 3 mm-8 mm.
  • the upper surface 28 of the lateral extensions 20 and 22 may be barbed for fixation to the inside surface of the disc annulus 42 and to resist expulsion through the aperture 44 .
  • the lateral extensions 20 and 22 have a greater thickness at the inside edge 24 than at the outside edge 26 .
  • the annulus stent 10 is a solid unit, formed from one or more of the flexible resilient biocompatible or bioresorbable materials well know in the art.
  • the selection of appropriate stent materials may be partially predicated on specific stent construction and the relative properties of the material such that, after fixed placement of the stent, the repair may act to enhance the healing process at the aperture by relatively stabilizing the tissue and reducing movement of the tissue surrounding the aperture.
  • the annulus stent 10 may be made from:
  • ePTFE expanded polytetrafluoroethylene
  • vascular grafts such as those sold by W.L. Gore and Associates, Inc. under the trademarks GORE-TEX and PRECLUDE, or by Impra, Inc. under the trademark IMPRA.
  • annulus, stent 10 may contain hygroscopic material for a controlled limited expansion of the annulus stent 10 to fill the evacuated disc space cavity.
  • annulus stent 10 may comprise materials to facilitate regeneration of disc tissue, such as bioactive silica-based materials that assist in regeneration of disc tissue as disclosed in U.S. Pat. No. 5,849,331 (Ducheyne, et al.), or other tissue growth factors well known in the art.
  • the left and right lateral extensions 20 and 22 join to form a solid pyramid or cone. Additionally, the left and right lateral extensions 20 and 22 may form a solid trapezoid, wedge, or bullet shape.
  • the solid formation may be a solid biocompatible or bioresorbable flexible material, allowing the lateral extensions 20 and 22 to be compressed for insertion into aperture 44 , then to expand conforming to the shape of the annulus' 42 inner wall.
  • a compressible core may be attached to the lower surface 30 of the lateral extensions 20 and 22 , forming a pyramid, cone, trapezoid, wedge, or bullet shape.
  • the compressible core may be made from one of the biocompatible or bioresorbable resilient foams well known in the art.
  • the core can also comprise a fluid-expandable membrane, e.g., a balloon.
  • the compressible core allows the lateral extensions 20 and 22 to be compressed for insertion into aperture 44 , then to expand conforming to the shape of the annulus' 42 inner wall and to the cavity created by pathologic extrusion or surgical removal of the disc fragment.
  • the lateral extensions 20 and 22 are compressed together for insertion into the aperture 44 of the disc annulus 42 .
  • the annulus stent 10 is then inserted into the aperture 44 , where the lateral extensions 20 , 22 expand.
  • the upper surface 28 can substantially conform to the contour of the inside surface of the disc annulus 42 .
  • the upper section 14 is positioned within the aperture 44 so that the annulus stent 10 may be secured to the disc annulus 42 , using means well known in the art.
  • the annulus stent 10 can be inserted laterally into the aperture 44 .
  • the lateral extensions 20 and 22 are compressed, and the annulus stent 10 can then be laterally inserted into the aperture 44 .
  • the annulus stent 10 can then be rotated inside the disc annulus 42 , such that the upper section 14 can be held back through the aperture 44 .
  • the lateral extensions 20 and 22 are then allowed to expand, with the upper surface 28 contouring to the inside surface of the disc annulus 42 .
  • the upper section 14 can be positioned within, or proximate to, the aperture 44 in the subannular space such that the annulus stent 10 may be secured to the disc annulus, using means well known in the art.
  • a first surgical screw 50 and second surgical screw 52 are inserted into the vertebral bodies, illustratively depicted as adjacent vertebrae 54 and 56 .
  • a suture 40 is passed down though the disc annulus 42 , adjacent to the aperture 44 , through the eye hole 53 on the first screw 50 then back up through the disc annulus 42 and through the orifice 18 on the annulus stent 10 . This is repeated for the second screw 52 , after which the suture 40 is secured.
  • One or more surgical sutures 40 are placed at about equal distances along the sides of the aperture 44 in the disc annulus 42 .
  • Reapproximation or closure of the aperture 44 is accomplished by tying the sutures 40 in such a fashion that the sides of the aperture 44 are drawn together.
  • the reapproximation or closure of the aperture 44 enhances the natural healing and subsequent reconstruction by the natural tissue crossing the now surgically narrowed gap in the annulus 42 .
  • the surgical sutures 40 are biodegradable but permanent non-biodegradable forms may be utilized. This method should decrease the strain on the disc annulus 42 adjacent to the aperture 44 , precluding the tearing of the sutures through the disc annulus 42 .
  • a flexible bladder 60 is attached to the lower surface 30 of the annulus stent 10 .
  • the flexible bladder 60 comprises an internal cavity 62 surrounded by a membrane 64 , where the membrane 64 is made from a thin flexible biocompatible material.
  • the flexible bladder 60 is attached to the lower surface 30 of the annulus stent 10 in an unexpanded condition.
  • the flexible bladder 60 is expanded by injecting a biocompatible fluid or expansive foam, as known in the art, into the internal cavity 62 .
  • the exact size of the flexible bladder 60 can be varied for different individuals. The typical size of an adult nucleus is about 2 cm in the semi-minor axis, 4 cm in the semi-major axis, and 1.2 cm in thickness.
  • the membrane 64 is made of a semi-permeable biocompatible material.
  • the mechanical properties of the injectate material may influence the performance of the repair and it is contemplated that materials which are “softer” or more compliant as well as materials that are less soft and less compliant than healthy nucleus are contemplated within the scope of certain embodiments of the invention. It must be understood that in certain embodiments the volume added to the subannular space may be less than equal to or larger than the nucleus volume removed. The volume of the implant may vary over time as well in certain embodiments.
  • a hydrogel is injected into the internal cavity 62 of the flexible bladder 60 .
  • a hydrogel is a substance formed when an organic polymer (natural or synthetic) is cross-linked via, covalent, ionic, or hydrogen bonds to create a three-dimensional open-lattice structure, which entraps water molecules to form a gel.
  • the hydrogel may be used in either the hydrated or dehydrated form.
  • an injection instrument as known in the art, such as a syringe, is used to inject the biocompatible fluid or expansive foam into the internal cavity 62 of the flexible bladder 60 .
  • the biocompatible fluid or expansive foam is injected through the annulus stent 10 into the internal cavity 62 of the flexible bladder 60 .
  • Sufficient material is injected into the internal cavity 62 to expand the flexible bladder 60 to fill the void in the intervertebral disc cavity.
  • the use of the flexible bladder 60 is particularly useful when it is required to remove all or part of the intervertebral disc nucleus.
  • the surgical repair of an intervertebral disc may require the removal of the entire disc nucleus, being replaced with an implant, or the removal of a portion of the disc nucleus thereby leaving a void in the intervertebral disc cavity.
  • the flexible bladder 60 allows for the removal of only the damaged section of the disc nucleus, with the expanded flexible bladder 60 filling the resultant void in the intervertebral disc cavity.
  • a major advantage of the annulus stent 10 with the flexible bladder 60 is that the incision area in the annulus 42 can be reduced in size, as there is no need for the insertion of an implant into the intervertebral disc cavity.
  • a dehydrated hydrogel is injected into the internal cavity 62 of the flexible bladder 60 .
  • Fluid, from the disc nucleus, passes through the semipermeable membrane 64 hydrating the dehydrated hydrogel.
  • the hydrogel absorbs the fluid the flexible bladder 60 expands, filling the void in the intervertebral disc cavity.
  • the annulus stent 10 is substantially umbrella shaped, having a central hub 66 with radially extending struts 67 .
  • Each of the struts 67 is joined to the adjacent struts 67 by a webbing material 65 , forming a radial extension 76 about the central hub 66 .
  • the radial extension 76 has an upper surface 68 and a lower surface 70 , where the upper surface 68 contours to the shape of the disc annulus' 42 inner wall when inserted as shown in FIG. 17A -C, and where the lower surface 70 contours to the shape of the disc annulus' 42 inner wall when inserted as shown in FIG. 16A -C.
  • the radial extension 76 may be substantially circular, elliptical, or rectangular in plan shape. Additionally, as shown in FIG. 20 , the upper surface 68 of the radial extension 76 may be barbed 82 for fixation to the disc annulus' 42 inner wall and to resist expulsion through the aperture 42 .
  • the struts 67 are formed from flexible material, allowing the radial extension 76 to be collapsed for insertion into aperture 44 , then the expand conforming to the shape of the inner wall of disc annulus 42 .
  • the annulus stent 10 is substantially frustoconical or shuttlecock shaped, and having a first end 72 , comprising the central hub 66 , and a second end 74 .
  • the radial extension 76 has a greater thickness at the central hub 66 edge than at the outside edge.
  • the annulus stent 10 is a solid unit, formed from one or more of the flexible resilient biocompatible or bioresorbable materials well known in the art.
  • annulus stent 10 may comprise materials to facilitate regeneration of disc tissue, such as bioactive silica based materials that assist in regeneration of disc tissue as disclosed in U.S. Pat. No. 5,849,331 (Ducheyne, et al.), or other tissue growth factors well known in the art.
  • a compressible core 84 may be attached to the lower surface 70 of the radial extension 76 .
  • the compressible core 84 may be made from one of the biocompatible or bioresorbable resilient foams well known in the art.
  • the compressible core 84 allows the radial extension 76 to be compressed for insertion into aperture 44 then to expand conforming to the shape of the disc annulus' 42 inner wall and to the cavity created by pathologic extrusion or surgical removal of the disc fragment.
  • a flexible bladder 80 is attached to the lower surface 70 of the annulus stent 10 .
  • the flexible bladder 80 comprises an internal cavity 86 surrounded by a membrane 88 , where the membrane 88 is made from a thin flexible biocompatible material.
  • the flexible bladder 86 is attached to the lower surface 70 of the annulus stent 10 in an unexpanded condition.
  • the flexible bladder 80 is expanded by injecting a biocompatible fluid or expansive foam, as known in the art, into the internal cavity 86 .
  • the exact size of the flexible bladder 80 can be varied for different individuals. The typical size of an adult nucleus is 2 cm in the semi-minor axis, 4 cm in the semi-major axis and 1.2 cm in thickness.
  • the membrane 88 is made of a semi-permeable biocompatible material.
  • the radial extension 76 is collapsed together, for insertion into the aperture 44 of the disc annulus 42 .
  • the radial extension 76 is folded such the upper surface 68 forms the outer surface of the cylinder.
  • the annulus stent 10 is then inserted into the aperture 44 , inserting the leading end 72 though the aperture 44 until the entire annulus stent 10 is within the disc annulus 42 .
  • the radial extension 76 is released, expanding within the disc 44 .
  • the lower surface 70 of the annulus stent 10 contours to the inner wall of disc annulus 42 .
  • the central hub 66 is positioned within the aperture 44 so that the annulus stent 10 may be secured to the disc annulus 42 using means well known in the art.
  • the radial extension 76 is collapsed together for insertion into the aperture 44 of the disc annulus 42 .
  • the radial extension 76 is folded such that the upper surface 68 forms the outer surface of the stent, for example in a frustoconical configuration as illustrated.
  • the annulus stent 10 is then inserted into the aperture 44 , inserting the tail end 74 through the aperture 44 until the entire annulus stent 10 is in the disc.
  • the radial extension 76 is released, expanding within the disc.
  • the upper surface 68 of the annulus stent 10 contours to the disc annulus' 42 inner wall.
  • the central hub 66 is positioned within the aperture 44 so that the annulus stent 10 may be secured to the disc annulus 42 , using means well known in the art.
  • the barbs 82 on the upper surface 68 of one or more strut 67 or other feature of the radial extension 76 engage the disc annulus' 42 inner wall, holding the annulus stent 10 in position.
  • an injection instrument as known in the art, such as a syringe, can be used to inject the biocompatible fluid or expansive foam into the internal cavity 86 of the flexible bladder 80 .
  • the biocompatible fluid or expansive foam is injected through the annulus stent 10 into the internal cavity 86 of the flexible bladder 80 .
  • Sufficient material is injected into the internal cavity 86 to expand the flexible bladder 80 to fill the void in the intervertebral disc cavity.
  • the material can be curable (i.e., glue).
  • the use of the flexible bladder 80 is particularly useful when it is required to remove all or part of the intervertebral disc nucleus.
  • one wall or barrier can be made stiffer and less resilient than others. This relatively stiff wall member can then be placed proximate the annulus wall and can advantageously promote, in addition to its reparative properties, bag containment within the annulus.
  • FIG. 22 shows a further aspect of the present invention.
  • a simplified schematic cross section of a vertebral pair is depicted including an upper vertebral body 110 , a lower vertebral body 112 and an intervertebral disc 114 .
  • An aperture or rent 116 in the annulus fibrosus (AF) is approached by a tube 118 , which is used to deliver a device 120 according to a further aspect of the present invention.
  • the device 120 may be captured by a delivery tool 122 through the use of a ring or other fixation feature 124 mounted on the repair device 120 .
  • FIG. 23 shows a delivery method similar to that depicted in FIG. 22 , with the exception that the tube 118 A has a reduced diameter so that it may enter into the sub-annular space of the disc 114 through the aperture or rent.
  • the delivery of the device 120 through the delivery tube 118 or 118 A may be facilitated by folding the arms or lateral extensions 128 , 130 of the device to fit within the lumen of the tube 118 or 118 A so that the stent or device 120 is introduced in a collapsed configuration.
  • the device 120 is moved through the lumen of the tubes 118 or 118 A through the use of delivery tool 122 .
  • FIG. 25 shows the arms deflected in a distal, or forward direction for insertion into the delivery tube 118 or 118 A while FIG. 24 shows the arms 128 , 130 deflected into a proximal position.
  • FIG. 25 shows the arms deflected in a distal, or forward direction for insertion into the delivery tube 118 or 118 A while FIG. 24 shows the arms 128 , 130 deflected into a proximal position.
  • 26 shows the device 120 curled so that one arm 128 is projecting distally, or in a forward direction, and the other arm 130 is projecting proximally, or in a rearward direction. Because the lateral extent of the device is relatively flexible, whether the device is of natural or synthetic material, other collapsible configurations consistent with the intent of this invention are also possible, including twisting, balling, crushing, etc.
  • FIG. 27 shows the device 120 having a series of peripheral barb structures typified by barb 132 located at the edges. In operation, these barbs may be forced into the annulus fibrosus as seen in connection with FIG. 28 .
  • Barb placement can be anywhere on the device 120 provided that at least some number of barbs are likely to find annulus fibrosus tissue to anchor in during placement. For a simple aperture or rent, placement on the periphery of the device body is a reasonable choice, but for complex tears, it may be desirable to place a plurality of barbs on the device not knowing in advance which barbs will find tissue to anchor in during placement.
  • FIG. 29 shows an alternative fixation strategy where a pair of barbs 134 and 136 are plunged into the annulus fibrosus from the exterior of the annulus while the device 120 is retained in the sub-annular space by means of a tether 142 .
  • a tether 142 may be knotted 145 with the band 144 holding the barbs 134 and 136 together to fix the device in the sub-annular space. The knot is shown in an uncinched position to clarify the relationship between the tether 142 and the bands 144 .
  • the device can be maintained in a subannular position by the barbed bands while the tether knot is cinched, advantageously simultaneously reapproximating the annulus to close the aperture while drawing the device into sealing, bridging engagement with the subannular wall of the annulus fibrosus.
  • FIG. 30 shows an alternative fixation strategy where the barbs 148 and 150 are sufficiently long that they can pierce the body of the device 120 and extend all the way through the annulus fibrosus into the device 120 .
  • the band 144 connecting the barbs 148 and 150 may be tightened to gently restrain and position the device 120 in the sub-annular space, or tightened with greater force to reapproximate the aperture or rent.
  • FIG. 31 shows a still further illustrative embodiment according to another aspect of the present invention.
  • a metal substrate 160 is incorporated into the device 120 .
  • This piece can be machined from flat stock and includes the loop 162 as well as barbs typified by barb 164 .
  • the structure shown in FIG. 31 is used in a manner analogous to FIG. 27 and FIG. 28 .
  • Stents can expand to be planar, for example as shown hereinabove in FIGS. 4, 8 , 9 , 11 and 12 , or they can expand to be three-dimensional as shown hereinabove in FIGS. 5 and 10 .
  • FIGS. 34-36 depict a further three dimensional patch/stent using an autograft formed of fascial tissue.
  • FIG. 34 shows the superior vertebral body 202 and the inferior vertebral body 204 surrounding a disc having an annulus fibrosus 206 and nucleus pulposus 203 in the subannular space.
  • a suture 210 is passed from outside the annulus through the wall of the annulus on one side of an aperture 208 and into the subannular space as shown.
  • FIG. 35 a fascial autograft 214 is then inserted through the aperture 208 into the subannular space using, for example, forceps 216 .
  • FIG. 36 shows the fascial stent/patch 214 fully inserted into the subannular space within the suture sling 212 .
  • the closure of the aperture is accomplished simultaneously with pulling the autograft 214 toward the annular wall as shown in FIG. 37 .
  • the suture 210 can be cinched 218 or tied to maintain the closure and the fixation of the patch/stent.
  • Patches can be folded and expanded in a single plane or in three dimensions. As shown in FIGS. 24-25 and 41 for example, collapsing the patch can be accomplished laterally, whether the device is a single material or composite. Other embodiments, such as that shown in FIG. 1 can collapse vertically, and still others such as that shown in FIG. 26 , longitudinally. Others can collapse in three dimensions, such as those shown in FIGS. 13-15 and 36 . Devices which expand in three dimensions can be packaged in a restraining jacket, such as a gelatine shell or “gelcap” for example, or a mesh of biosorbable or dissolvable material, that would allow for facile placement and subsequent expansion.
  • a restraining jacket such as a gelatine shell or “gelcap” for example, or a mesh of biosorbable or dissolvable material, that would allow for facile placement and subsequent expansion.
  • Patches can also be constructed of a single component, as shown for example in FIG. 36 , made of autograft or a synthetic material such as Dacron, or for example where the stent is a gelcap. They can be made of multiple components.
  • An exemplary stent (not shown) can be made from a polymeric material, for example silicone rubber, which can be formed to have a natural unstressed shape, for example that of a “Bulb”.
  • a stylet or push-rod can, for example, be inserted on the inside of the bulb to stretch the bulb into a second shape which is thinner and elongated. The second shape is sufficient to place within the aperture in the annulus.
  • the push-rod Upon placement of the device within the sub-annular space, the push-rod is removed and the bulb assumes it natural, unstressed state, assuming a larger dimension within the sub-annular space.
  • silicone is used in this example, other metallic constructs could also be envisioned such as a Nitinol braided device that has a natural unstressed shape and assumes a second shape under tension for the delivery of the device. It is also contemplated that the opposite scenario can also accomplish the similar objective.
  • the device can have a first configuration that is unstressed and elongated and assumes a second, larger configuration (bulb) under stress.
  • a portion of the stylet or rod that is used to mechanically activate the device would be left behind to hold the expansion element in its stressed configuration.
  • Multiple components could include a frame to help with expansion of the device and a covering to obtain biocompatibility and tissue ingrowth.
  • frame configurations might include an expandable “Butterfly” or “Figure-8” configuration that could be constructed of wire material, such as Nitinol or multiple wires.
  • Exemplary embodiments showing frame members 502 are depicted in FIG. 41A -E. Of course, other configurations such as diamonds or other rounded or polygonal shapes can be used.
  • the diamond frame is a construct that takes a first form that is smaller and expands to a larger frame.
  • the diamond elements could be constructed from a single wire or from multiple wires. Alternatively, the members could be constructed of elements that are moveable fixed at each of the ends to allow expansion.
  • a tether or attachment device 504 is also depicted, which may be a suture, a wire, a screw, or other attachment means known in the art.
  • the frame could be cut from a single material, such as flat stock Nitinol to accomplish the same objective, as shown for example in FIG. 31 .
  • Such shapes can be cut from flat stock using known methods, for example, laser cutting.
  • a heat forming step could also be employed, as known in the art, to form barbs 132 in a shape that passes out of the flat plane of the stock material, as shown in FIG. 27 for example.
  • Another frame configuration is that of a spiral or coil.
  • the “Coil” design can be, for example, a spring steel or other biocompatible material that is wrapped to a first “wound” smaller configuration and expands to a larger unwrapped, unwound configuration.
  • each of these concepts may or may not have a covering over them in order to assure that the nucleus does not re-extrude from the intervertebral disc space after placement of the device, as well as to serve as substrate for the surrounding tissue to naturally incorporate the device.
  • Coverings might include ePTFE, polyester, silicone, or other biocompatible materials. Coverings could also include natural materials such as collagen, cellulose, autograft, xenograft, allograft or similar materials. The covering could also be biodegradable in nature, such as polyvinyl lactic acid.
  • Frames that are not covered may be permeable, such as a patch that is porous and allow for normal movement of fluids and nutrients through the patch into and out of the annular ring while maintaining nucleus fragments larger than the porosity of the stent/patch within the subannular space.
  • a surface finish may be added to promote tissue ingrowth into the patch.
  • a titanium sputtering of the device may allow it to be more easily incorporated within the disc space.
  • a NiTi or tantalum foam could be added to the outer surface of the patch to promote tissue ingrowth.
  • the stent/patch according to the present invention may comprise a mass of fascial autograft, and that autograft may be contained in a covering of material to form what will be referred to herein as a “bag”.
  • this term is used not necessarily to connote a five-sided closed container so much as to denote the notion of flexibly surrounding the volume of a patch/stent material so that it can be manipulated in space.
  • a prefabricated device of sutures could be used to form the “sling” to hold the fascial implant as discussed above.
  • the advantage of this design over simple placement of sutures to hold the autograft is better containment and control of the autograft during and after implantation.
  • the “sling” or a “bag” surrounds the fascial autograft to hold it in place. It is contemplated that other materials, such as a polyester mesh, could be used instead of the fascial autograft.
  • FIG. 38 shows an example of a pre-fabricated sling 300 .
  • a collar member 308 has apertures or other features for attaching to the sutures.
  • the third suture 306 passes along or within the collar 308 to form a loop extending from the lateral extent of the collar 308 .
  • the first and second sutures 302 , 304 form loops from the superior and inferior extents of the collar 308 .
  • Intersections 310 can secure the loops to each other with small loops or knots in the sutures, small fabric attachment pieces, or by small preformed devices resembling grommets placed on the suture to aid in securement. Other knot tying techniques known in the art can also be employed.
  • FIG. 39 the collar is depicted within the subannular space where the loops surround a fascial autograft 314 which by pulling proximally the sutures 302 , 304 , 306 the graft is collapsed into contact with the annular wall in a sealing manner.
  • the sutures can be made of known materials, e.g., biodegradable, bioabsorbable or bioresorbable Vicryl or biocompatible nylon.
  • the collar can be made of a fabric material, e.g., polyester.
  • a fabric material e.g., polyester.
  • one end of some or each suture can be passed through the inferior wall of the annulus and the other end can be passed through the superior wall surrounding the aperture.
  • the fascial autograft is placed within the sling. The sutures are tightened to bring the tissues together and also to help reapproximate the aperture, as the collar size will be selected based on the surgeon's judgment according to the degree of reapproximation desired.
  • FIG. 40 Other constructions can also be used to accomplish the same objective, such as a “bag” 404 formed of expandable PTFE as shown in FIG. 40 .
  • the bag is placed through an aperture in the annulus 402 .
  • a one way seal 406 can be positioned behind the aperture 408 . Suturing techniques for introducing cardiac valves could be employed to place the seal. It is understood that there could be multiple constructs to accomplish the same objective and this is only given as an example.
  • FIG. 20 also depicts the use of “barbs” on the surface of the stent to facilitate fixation to the annulus. In a simple example, as shown in FIG.
  • a patch/stent could be compressed, passed through a guide tube such as tubes 18 , 18 A shown in FIGS. 22 and 23 , and expanded within the sub-annular space.
  • a guide tube such as tubes 18 , 18 A shown in FIGS. 22 and 23
  • the expanded patch 602 is shown having barbs 604 , along with detachable delivery tool 608 and guide tube 606 .
  • barbs 604 on the outer surface of patch 602 can be used to fix the patch into the inner wall 610 of the annulus 612 by pulling the patch back proximally, into the sub-annular wall 610 , and pushing forward distally on the guide tube 606 , thus driving the barbs 604 into the annulus and drawing the inner and outer tissues of the annulus together and reapproximating the disc on either side of the aperture, as shown in FIG. 43 .
  • the delivery tool and guide tube are removed.
  • Anchoring barbs could be made of a biocompatible material, for example a metallic material (e.g., NiTi alloy, Stainless steel, Titanium), or a polymeric material (e.g., polypropylene, polyethylene, polyurethane).
  • Anchoring barbs could also be a biodegradable/bioabsorbable material, such as a polyglycolic acid (PGA), a polylevolactic acid (PPLA), a polydioxanone (PDA) or for example a racemic polylactic acid (PDLLA).
  • PGA polyglycolic acid
  • PPLA polylevolactic acid
  • PDA polydioxanone
  • PDLLA racemic polylactic acid
  • the barbs included a biodegradable/bioabsorbable material, it is anticipated that the barbs might have sufficient holding strength for a sufficient period of time to allow the patch to be incorporated into the annulus during the healing process.
  • the advantage of having the anchoring barb of FIGS. 42 and 43 being biodegradable/bioabsorbable is that after the incorporation of the patch into the annulus there may be no need for the barbs to provide fixation.
  • barbs pointing toward the outer surface of the annulus could pose a long term risk of penetration out of the annulus due to migration, and potentially impinging on the nerve root and spinal canal.
  • Biodegradable/bioabsorbable barbs address and advantageously reduce any long-term risk in this regard.
  • the barbs could be made of both a biocompatible component and a biodegradable/bioabsorbable component.
  • the very tip of the barb could be made of a biodegradable material.
  • the barb could penetrate the annulus wall with a rather sharp point, but after degradation the point of the barb would become dull. In this embodiment, the point would no longer induce continued scar formation after the patch has been incorporated, nor pose a risk of penetrating out of the annulus onto the nerve root.
  • Another fixation means includes the passing of “anchoring bands” into the wall of the annulus, vertebral bodies (superior, inferior, or both), or the Sharpey's Fibers (collagenous fibers between the junction of the annular fibers and vertebral bodies).
  • anchors the barbs or bands are affixed to the annulus/vertebral bodies/Sharpey's fibers.
  • Another element for example a suture, cinch line, or a staple is utilized to attach the anchor bands to the patch, and thus hold the patch in proximity to the inner wall of the annulus.
  • these bands may re-approximate the tissues at the aperture.
  • FIG. 9 Revisiting one example of using barbs to anchor the device is shown in FIG. 9 , described hereinabove.
  • Barbs or bone anchor screws 50 ands 52 are passed into the superior and inferior vertebral bodies 54 and 56 , respectively.
  • Superiorly, suture 40 is passed through the outer wall of the annulus, to the sub-annular space.
  • the suture is then passed through the eyelet 53 of bone anchor 52 and then passed through the wall of the annulus from the sub-annular space to the outer wall of the annulus.
  • the inferior end of the suture is similarly passed through the annulus, eyelet of the bone anchor, and back through the wall of the annulus. Both ends of suture 40 are tightened and tied.
  • the advantage of this concept is that it allows for fixation of the device to a surface that is known to be present in all discectomy procedures—the vertebral bodies. Whereas, it is possible, depending on the location and size of a natural rent that there may not be sufficient annulus accessible to fixate the device directly to the annulus. In addition to providing a location for fixation, anchoring into the vertebral bodies may provide a more stable anchor surface.
  • FIG. 29 Another example of fixating the device to inner wall of the annulus is shown in FIG. 29 , and is further illustrated by FIGS. 44-47 .
  • a patch 120 is placed with a delivery tool 122 , through the inner lumen of a guide tube 118 , into the sub-annular space and then expanded. This step can also be seen in FIGS. 45 and 46 , where a patch 702 is folded and passed through a guide tube 706 and is held by a delivery tool 704 .
  • a anchor band or staple 709 and an anchor band delivery device 708 are also shown.
  • a suture line or cinch line 710 that is attached to the center of the patch 702 .
  • FIG. 44 a With the guide tube 706 removed.
  • the guide tube 706 is retracted after the patch 702 has been expanded and deployed.
  • an anchor band delivery tool 708 is used to deliver one or more “bands” 709 onto the outer surface of the annulus. These are intended to be anchored into the wall of the annulus with barb shapes that do not allow for the barbs to be pulled back through the annulus.
  • the anchor bands resemble a construction of a “staple”.
  • the bands could actually be constructed by connecting two barbed elements with, for example, a suture between the two barbed elements.
  • the barbs and the connection band between the barbs could be constructed of the same material or of different materials.
  • the barbed part of the anchor band could be a biodegradable/bioabsorbable material (such as polyglycolic acid) or could be constructed of a metallic or polymeric biocompatible material (e.g., titanium, NiTi alloy, stainless steel, polyurethane, polypropylene).
  • the band that connects these barbs can be constructed of materials that are similar to the barbs, or different materials.
  • connection band could be a biodegradable/bioabsorbable suture, such as Vicryl, or a biocompatible material such as polypropylene.
  • these elements are constructed from multiple materials to accomplish the objective of anchoring into the annulus and providing for a fixation site to draw the patch within proximity of the sub-annular wall.
  • FIGS. 44B and 44C show the placement of the anchor bands 709 into the annulus 712 with the anchor band delivery tool 708 .
  • FIGS. 46A and 46B schematically show the placement of the anchor bands 709 into the wall of the annulus 712 and the retraction of the anchor band delivery device 708 , with the patch delivery tool 704 still in place.
  • FIG. 44D depicts a representative anchor band 709 , having a pair of stainless steel barbs 709 ′′ connected by a suture 709 ′.
  • FIG. 44E shows the patch 702 , anchor bands 709 , and cinch line or suture 710 with the delivery tools removed, prior to drawing the patch and the tissues of the annulus together.
  • FIG. 47 a also shows a posterior view of the patching of the annulus with this device with knot 714 .
  • this stent/patch 702 a pair of loops of 7 mm suture 709 are shown, which engage the cinch line and slip knot. These suture loops connect to the barbs directly, as in FIG. 44 , or loop to surgical staples, or are placed directly into the annulus.
  • the presence of a pre-fabricated knot on the cinch line makes the process of repairing quicker since there is no need to tie a knot. It also facilitates drawing the tissues together.
  • FIG. 44E is similar to the FIG. 29 described hereinabove prior to “tying” the knot 145 .
  • FIG. 44F shows the drawing of the patch and the annular tissues together by pulling on the suture in the direction “A” indicated by the arrow.
  • the Knot Pusher has been removed from the cinch line 710 .
  • the suture 710 is drawn proximally to draw the patch 702 into engagement with the inner wall of the annulus to seal the aperture from within, as well as draw the walls of the annulus together to reapproximate the annular aperture.
  • 44G show the cinch line suture 710 tied and drawing the annular tissues together, after the excess suture line has been cut. It is also apparent from this device, fixation and delivery system that the outer surfaces of the aperture are also drawn together for re-approximation.
  • the cinching of the bands and the patch also allows for taking-up the slack that allows for the accommodation of varying sizes.
  • the thickness of the annular wall surrounding the aperture can vary from 1 mm up to 10 mm. Therefore, if the anchor bands have a set length, this design with an cinch line accommodates different dimensions of the thickness of the wall of the annulus by drawing the “slack” of the bands together within the aperture.
  • the patch depicted in the example above does not have barbs attached to the patch, it is also possible to have the barbs as described hereinabove to further promote the fixation of the patch to the inner wall of the annulus.
  • FIG. 51 shows the illustrative filling of an aperture with implant material 716 prior to cinching the suture 710 .
  • the anchor bands 709 as described previously could be sufficiently long enough to pass through the annulus and then through the patch.
  • the barbs in this embodiment have an engaging involvement with the patch. This concept was previously discussed hereinabove in connection with FIG. 30 . Further illustration of such a system is schematically shown in FIGS. 49 and 50 . Passing the barbs through the patch, in this embodiment, provides additional security and safety of reducing the possibility that the barbs may migrate after implantation.
  • the suture cinch line may ( FIG. 50 ) or may not ( FIG. 30 ) be used in addition to the anchor bands to draw the tissues together and reduce tissue movement surrounding the aperture.
  • the bands shown in FIGS. 49 and 50 take the form of a “barb”, they could as easily take a form of a simple T-barb 720 , as shown in FIG. 52E , or a C-type element wherein the object is to have irrevocable engagement with the patch device 702 after the penetration through the patch.
  • a T-type attachment when aligned longitudinally with the suture, passes through the patch. The T section then rotates to prevent the suture anchor from being pulled back through the patch.
  • a “C’ retainer made of a superelastic material may be attached to the end of the suture band. The C retainer is loaded into a needle wherein it is held straight. The needle is used to pass the C retainer and suture through the patch and deploy the retainer in a second configuration in the shape of a “C”.
  • patch designs which will accommodate the placement and securement of the anchor to the fabric that covers the frame of the patch.
  • a frame for a patch that is made out of metal such as Nitinol can provide for “windows”.
  • the device, covered with a mesh fabric, for example silicone or Dacron, would therefore allow the anchoring barbs to be passed through the “windows” in the frame of the patch. In this case, the barb can be secured to the patch in the fabric covering the frame.
  • the patch can be secured by passing barbs that engage the lattice of the patch frame.
  • barbs that engage the lattice of the patch frame.
  • These embodiments of the invention illustrate designs in which the barbs engage with the vertical, horizontal or criss-crossed structures/members of the frame. In this case, the barbs would pass through the mesh or lattice of the frame and they would be unable to pass back out of the structure.
  • anchor bands that are shown to be two anchors connected by a suture
  • single barbs with sutures are placed and the sutures' ends, at the outer surface of the annulus, are tied after placement through the patch.
  • One objective in the designs discussed hereinabove is to provide a way to “pull up the slack” in a system to adjust the length of sutures and for anchor bands.
  • a technique referred to as the “Lasso Cinch Knot” was developed as a means to draw the anchor bands together with a suture cinch line that is incorporated into the patch design.
  • FIG. 53 gives further description of the use of the Lasso embodiment.
  • patch and frame constructs are used that incorporate the “barbs through the patch” design. Once the barbs have passed through the patch, an internal lasso 722 is drawn tight around the sutures of the anchor bands and thus draws the extra suture material within the patch.
  • the internal lasso gathers the sutures of the bands, and as the lasso is tightened, it cinches together the sutures of the bands and therefore tightens them and eliminates slack, bringing the patch/stent into closer or tighter engagement with the annulus wall.
  • the patch in FIG. 53 additionally provides for a diamond shape grid pattern, which advantageously provides a grid which will while allowing a probe or similar instrument to pass through with little resistance, provides resistance to a barb or other restraining feature on the instrument.
  • the frame shown can be made from nitinol, and the locking and holding windows shown at the center of the figure would allow for rotation about the z-axis during placement.
  • a slipknot technique using, for example a knot pusher would aid in the loop pulling process by the lasso.
  • the internal loop (lasso) can be tacked to the outside corners of the patch/stent, in order to hold the loop at the outer edges of the patch frame.
  • the loop can be pulled free from some or all of its tacked attachment points to the frame, to prevent deformation of the planar shape of the frame when cinching the lasso.
  • the frame can be a composite structure or sandwich formed with some type of mesh fabric.
  • the proximal mesh fabric can be bonded fully to the patch frame, for example through the use of an adhesive, for instance a silicone.
  • Adhesive advantageously, can fill the interstices of the grid pattern while allowing for easy probe penetration and protection of the suture lines. Protection of the suture lines is advantageous when the lasso is used to pull and bunch a group of band sutures together.
  • sutures 710 ′ can be preattached directly to a stent/patch. As shown in FIG. 52A several separate barbs 709 ′′′ into the annulus 712 can be directly attached to the patch 702 . Each “barb” of FIG. 52A can be independently placed into the annulus after the patch is deployed. This can be seen to be similar to the embodiment including barbs 709 ′′′′ of FIG. 55 .
  • An alternative embodiment for securing a patch 902 and reapproximating a rent is providing each of the separate barbs with sutures having variable lengths as shown in FIG. 56 .
  • Each independent suture barb 904 is placed into the annulus 906 or into the patch 902 with the barb delivery tool 908 .
  • all of the suture lines 910 are drawn taught, by drawing on the free ends that exit the patch delivery tool 912 .
  • a locking element 914 that uses a gasket 916 and threading mechanism is attached to the patch 902 and is used to tighten the gasket 916 around the distal ends of the sutures 910 .
  • the patch delivery tool 912 is removed and the extra suture length is cut.
  • the gasket mechanism could be a press-fit to accommodate the tightening of the sutures to the patch.
  • the locking mechanism can be as shown in FIG. 57 , although in this case the engagement of the locking element 914 ′ takes part on the patch. Pulling the suture 910 in the direction of arrow B will tighten and lockingly hold in tension to aid in securement and reapproximation.
  • the adjustable length suture band between the two anchors allows slack to be taken up between the anchors 916 .
  • Two T-type anchors are illustratively shown in this example, but multiple anchors of differing configurations could be used.
  • the locking features can be included on the feature band, as depicted here, and allow for substantially one-way locking engagement with the anchor members. This adjustability advantageously promotes for the accommodation of varying thickness of the annulus from patient to patient.
  • the suture slack in this embodiment may be taken up to close the defect in the annulus and/or to shorten the band between anchors for a secondary cinching of multiple tensioned suture bands as described hereinabove.
  • the cinch line and the Lasso concepts in essence try to facilitate the re-approximation and drawing of tissues together in a fast and simple way.
  • Other contemplated embodiments for “tension” elements include using an elastic coupler as a part of the anchor band used to fixate the device.
  • the elastic coupler can be expanded for placement, and upon release, can draw tension to pull the tissues together.
  • the coupler could be made of a biocompatible metal or polymer, or could be constructed of a biodegradable/bioabsorbable material.
  • an alternative embodiment to cause tension within the device and draw the tissues together after placement of the anchor bands might include an elastic band or band with a spring which one end can be attached to the anchor bands and the other end attached to the patch.
  • the anchor bands might, in and of themselves may be made of an elastic band between the barbs, or may contain a spring element between the barbs. Such an embodiment can be made to resemble a so-called “Bobber Spring.”
  • the elastic or resilient element could be made from a wide variety of metals, polymeric, or biodegradable/bioabsorbable material.
  • FIG. 59 describes an embodiment where the patch element 1002 takes the form of a mesh seal.
  • the securement is effected by a hook having a barb element 1004 that penetrates the inner surface of the annulus 1006 , while the inner connection of the hook (barb) 1004 is attached to the patch in such a fashion as to add tension between the outer surface of the annulus and the inner surface in proximity to the patch, thus drawing the annular tissues together.
  • the patch/stent 1002 contains a spring ribbon element 1008 which can be formed from nitinol or other spring material. Hooks 1010 are then deployed to “grab” the annulus, either through penetration or through grasping into the aperture 1012 as shown.
  • FIGS. 54 a - f shows another embodiment of a means to draw the suture lines together to cause tension between the inner and outer tissues of the annulus.
  • Anchor bands for example T-barbs 720 ′ are placed through the annulus and the patch, and they are secured to the patch 702 .
  • “Slack” in the suture of the anchor band is “rotated” around a detachable portion of the delivery tool 704 ′ and a locking element, for example a screw configuration 724 as shown in the drawing, is used to lock the extra suture line in place affixed to threads 726 with the patch 702 .
  • the delivery tool 704 ′ is then removed.
  • FIG. 58 shows alternative embodiments for tightening “anchoring barbs” with different configurations of sutures and cinch lines.
  • each independent barb has a looped suture attached to it. Through each of these loops is passed a cinch line, which contains a knot. After placement of the barbs within the annulus, and possibly through the patch, the cinch line draws the loops of the barbs together.
  • the advantage of this embodiment is that it allows for the independent placement of multiple barbs and the ability to draw all of them together.
  • cinch lines have been described as using a knot to “lock” the length of the suture, other mechanisms could also lock the length, as shown in FIG. 57 .
  • the locking of the suture length is accomplished through a mechanical element located on the barb which engages with three dimensional elements attached to the suture line which mechanically press fit through the engagement element on the barb, thus locking the length of the suture line into place.
  • FIG. 57 and FIG. 58 depict the use of a single locking mechanism (e.g., knot on cinch line), it is conceivable that various designs could use more than one locking element to achieve the re-approximation and drawing together the tissue surrounding an aperture.
  • a single locking mechanism e.g., knot on cinch line
  • a further exemplary embodiment of the invention further describes a concept illustrated by FIG. 41 e , for example.
  • a braided patch 1100 such as depicted in FIGS. 60 through 66 , is a further illustrative embodiment of the present invention that can be deployed into the subannular space to act as a barrier to the extrusion of the nucleus pulposus.
  • the “patch” 1100 is constructed from a braided tube of filaments 1102 .
  • the ends 1104 of the braided tube are heat-sealed to keep the braid from unraveling and the seals also provide structural integrity to the patch when deployed.
  • the braided patch 1100 is woven on a braiding machine with multiple filaments 1102 to create the structure.
  • the patch can be woven with 72 polyester filaments in order to create the construct that readily deploys into the annular defect, promotes cell ingrowth into the device, and retains an anchor after it has been placed through the wall of the annulus and through the patch.
  • the braided patch can be made on a standard Steeger braider, or similar type braiding machine, that can handle braiding from anywhere from 16 filaments at a time, to up to 196 filaments.
  • the patch is braided with between 32 to 144 filaments.
  • the filaments 1102 of the patch can be made of different materials or all of the filaments in a patch can be of like material and dimensions.
  • the filaments can be metallic, such as a stainless steel, a nickel titanium alloy, or other metallic materials.
  • the patch 1100 can also be made from biocompatible polymeric material such as polyethyleneteraphthalate, polyester, polyethylene, or polypropylene, for example. It is also conceivable that the patch can be braided from biodegradable materials, such as polyglycolic acid (PGA), polylactic acid (PLA), or other material that may degrade and be re-absorbed by the body over time.
  • biodegradable materials such as polyglycolic acid (PGA), polylactic acid (PLA), or other material that may degrade and be re-absorbed by the body over time.
  • the patch 1100 can be braided with multiple materials and/or multiple dimensions of the filaments.
  • the patch can be braided with 32 filaments of a polymeric PET material and 32 filaments of polyester yarn material to create a patch that is optimal for sealing an annulus.
  • the combination of different filament materials, sizes, cross-sectional configuration, number of filaments, and braiding pattern can be used to construct a braided patch that can be delivered into the sub-annular space, while acting as a scaffold to induce healing of the aperture.
  • the braided patch has advantages in that it can be placed through an aperture in the wall of the annulus that is relatively small, but then expand to a dimension that is substantially greater than the aperture. For example, it is possible to construct the braided tube to be less than 5 mm in diameter, whereas in its fully deployed state it could be greater than, for example, 20 mm.
  • the non-deployed braided patch 1100 is affixed on the distal end of the patch delivery tool 1200 . It is situated in a fashion that is co-axial with the delivery tool's delivery members. Further detail of the deployment mechanism can be seen in FIG. 63 .
  • the braided patch 1100 is placed on the distal end of the inner delivery member 1202 .
  • the heat-set distal cuff 1104 of the patch is situated within a depressed region on the distal region of the inner delivery member 1216 .
  • the distal portion of the delivery member 1216 is slotted as shown in FIG.
  • the delivery device is passed into the aperture of the annulus. Once inside the annular aperture, the outer pusher member 1204 of the delivery device 1200 is pushed toward the distal end of the device, while the inner delivery member 1202 is pulled proximally. This action of moving these members in such a fashion results in the braided patch expanding perpendicular to tube's axis, as shown in FIGS. 61 and 64 .
  • a cinch line 1212 that is connected to the distal and proximal ends of the patch can be tightened and a knot, such as a Roeder knot, can be used to hold the braided patch in its expanded configuration.
  • a knot such as a Roeder knot
  • the device is shown with a cinch knot 1214 , it is possible that a locking element may not be needed, depending on the means used to fixate the patch into the annulus. It is possible that no locking means is necessary. It is also possible that alternative locking means can be contemplated to keep the braided patch in its expanded form.
  • a knot pusher 1210 can also be employed to manipulate the knot locking device 1214 .
  • the retention member can be removed from the distal portion of the inner member by slidably pulling the proximal end of the retention member in a proximal direction. Removing the retention member relieves the stress holding the distal cuff of the patch in place and allows the patch to be slideably removed from the distal end of the delivery device, and thus deployed into the subannular space.
  • the patch 1100 can be affixed to the inner surface either before or after the deployment of the patch from the delivery device. It is also contemplated that this patch can be affixed to the inner surface of the annulus by the various fixation means described in other parts of this application.
  • anchor bands as shown in FIG. 29 could be used to penetrate the annulus and the patch to anchor the patch into the sub-annular space.
  • single T-anchors 1310 with a band 1314 e.g., suture
  • single T-anchors 1310 with a band 1314 could be delivered through the annulus 1306 and patch 1100 with the portion of the suture on the outer surface of the annulus locked to the outer surface with a knot, pledget, or other locking device 1316 .
  • the patch could be affixed to the inner surface of the annulus through the use of adhesives, such as cyanoacrylate, fibrin glue, polymer protein, polyurethane or other material used to cure the patch in the subannular space in situ.
  • Path 1312 illustrated another possible suture path through the bone of the vertebra to penetrate and hold a T-anchor member 1310 in the patch.
  • the body portions of the stent could be made of NiTi alloy, plastics including polypropylene and polyethylene, stainless steel and other biocompatible metals, chromium cobalt alloy, or collagen.
  • Webbing materials can include silicone, collagen, ePTFE, DACRON, polyester, polypropylene, polyethylene, and other biocompatible materials and can be woven or non-woven.
  • Membranes might be fashioned of silicone, propylene, polyester, SURLYN, PEBAX, polyethylene, polyurethane or other biocompatible materials.
  • Inflation fluids for membranes can include gases, liquids, foams, emulsions, and can be or contain bioactive materials and can also be for mechanical, biochemical and medicinal purposes.
  • the stent body, webbing and/or membrane can be drug eluting or bioabsorbable, as known in the medical implant arts.

Abstract

A spinal disc annulus repair stent for repair and reconstruction of the spinal disc wall (annulus) after surgical invasion or pathologic rupture, which may incorporate suture closure or other means of stent insertion and fixation, designed to reduce the failure rate of conventional surgical procedures on the spinal discs. In an illustrative embodiment, the design of the spinal disc annulus stent advantageously allows ingrowth of normal cells of healing in an enhanced fashion strengthening the normal reparative process.

Description

    CROSS-REFERENCE TO A RELATED APPLICATION
  • This application is a continuation of U.S. application Ser. No. 10/352,981, filed Jan. 29, 2003, now pending. U.S. patent application Ser. No. 10/352,981 is a continuation-in-part of U.S. patent application Ser. No. 10/133,339, filed Apr. 29, 2002, now pending, which is a continuation-in-part of U.S. patent application Ser. No. 09/947,078, filed Sep. 5, 2001, now U.S. Pat. No. 6,592,625, which is a continuation of U.S. patent application Ser. No. 09/484,706, filed Jan. 18, 2000, now abandoned, which claims the benefit of U.S. Provisional Application No. 60/160,710, filed Oct. 20, 1999. U.S. patent application Ser. No. 10/352,981 is also a continuation-in-part of U.S. patent application Ser. No. 10/075,615, filed on Feb. 15, 2002, now pending, and it also claims the benefit of U.S. Provisional Application No. 60/309,105, filed Jul. 31, 2001. The entire contents of each of the above are incorporated herein by reference.
  • FIELD OF THE INVENTION
  • The invention generally relates to methods and implantable medical devices for the closure, sealing, and/or repair of an aperture in the intervertebral disc annulus. The term “aperture” refers to a hole in the annulus that is a result of a surgical incision into the intervertebral disc annulus, or the consequence of a naturally occurring tear (rent). The invention generally relates to surgical devices and methods for intervertebral disc wall repair or reconstruction. The invention further relates to an annular repair device, or stent, for annular disc repair. These stents can be of natural or synthetic materials. The effects of said reconstruction are restoration of disc wall integrity and reduction of the failure rate (3-21%) of a common surgical procedure (disc fragment removal or discectomy). This surgical procedure is performed about 390,000 times annually in the United States.
  • BACKGROUND OF THE INVENTION
  • The spinal column is formed from a number of bony vertebrae, which in their normal state are separated from each other by intervertebral discs. These discs are comprised of the annulus fibrosus, and the nucleus pulposus, both of which are soft tissue. The intervertebral disc acts in the spine as a crucial stabilizer, and as a mechanism for force distribution between adjacent vertebral bodies. Without the disc, collapse of the intervertebral space occurs in conjunction with abnormal joint mechanics and premature development of arthritic changes.
  • The normal intervertebral disc has an outer ligamentous ring called the annulus surrounding the nucleus pulposus. The annulus binds the adjacent vertebrae together and is constituted of collagen fibers that are attached to the vertebrae and cross each other so that half of the individual fibers will tighten as the vertebrae are rotated in either direction, thus resisting twisting or torsional motion. The nucleus pulposus is constituted of loose tissue, having about 85% water content, which moves about during bending from front to back and from side to side.
  • The aging process contributes to gradual changes in the intervertebral discs. The annulus loses much of its flexibility and resilience, becoming more dense and solid in composition. The aging annulus may also be marked by the appearance or propagation of cracks or fissures in the annular wall. Similarly, the nucleus desiccates, increasing viscosity and thus losing its fluidity. In combination, these features of the aged intervertebral discs result in less dynamic stress distribution because of the more viscous nucleus pulposus, and less ability to withstand localized stresses by the annulus fibrosus due to its desiccation, loss of flexibility, and the presence of fissures. Fissures can also occur due to disease or other pathological conditions. Occasionally fissures may form rents through the annular wall. In these instances, the nucleus pulposus is urged outwardly from the subannular space through a rent, often into the spinal column. Extruded nucleus pulposus can, and often does, mechanically press on the spinal cord or spinal nerve rootlet. This painful condition is clinically referred to as a ruptured or herniated disc.
  • In the event of annulus rupture, the subannular nucleus pulposus migrates along the path of least resistance forcing the fissure to open further, allowing migration of the nucleus pulposus through the wall of the disc, with resultant nerve compression and leakage of chemicals of inflammation into the space around the adjacent nerve roots supplying the extremities, bladder, bowel, and genitalia. The usual effect of nerve compression and inflammation is intolerable back or neck pain, radiating into the extremities, with accompanying numbness, weakness, and in late stages, paralysis and muscle atrophy, and/or bladder and bowel incontinence. Additionally, injury, disease, or other degenerative disorders may cause one or more of the intervertebral discs to shrink, collapse, deteriorate, or become displaced, herniated, or otherwise damaged and compromised.
  • The surgical standard of care for treatment of herniated, displaced, or ruptured intervertebral discs is fragment removal and nerve decompression without a requirement to reconstruct the annular wall. While results are currently acceptable, they are not optimal. Various authors report 3.1-21% recurrent disc herniation, representing a failure of the primary procedure and requiring re-operation for the same condition. An estimated 10% recurrence rate results in 39,000 re-operations in the United States each year.
  • An additional method of relieving the symptoms is thermal annuloplasty, involving the heating of sub-annular zones in the non-herniated painful disc, seeking pain relief, but making no claim of reconstruction of the ruptured, discontinuous annulus wall.
  • Some have also suggested that the repair of a damaged intervertebral disc might include the augmentation of the nucleus pulposus, and various efforts at nucleus pulposus replacement have been reported. The present invention is directed at the repair of the annulus, whether or not a nuclear augmentation is also warranted.
  • In addition, there has been experimentation in animals to assess various surgical incisions with and without the direct surgical repair of the annulus. These studies were performed on otherwise healthy animals and involved no removal or augmentation of nucleus pulposus. The authors of these experiments conclude that direct repair of the annulus does not influence the healing of the disc.
  • There is currently no known method of annulus reconstruction, either primarily or augmented with an annulus stent.
  • BRIEF SUMMARY OF THE INVENTION
  • The present invention provides methods and related materials for reconstruction of the disc wall in cases of displaced, herniated, ruptured, or otherwise damaged intervertebral discs. In accordance with the invention, a method is disclosed for intervertebral disc reconstruction for treating a disc having an aperture in the wall of the annulus fibrosis, wherein the aperture provides a path for the migration of nucleus pulposus from the subannular space, the method including the steps of providing an expandable patch having a first configuration dimensioned to pass through the aperture and a second expanded configuration having at least one dimension at least as large as the aperture and having at least one dimension larger than a corresponding dimension in said first configuration; inserting the patch through the aperture into the subannular space when the device is in the first collapsed configuration; and causing or allowing the patch to expand in the subannular space into the second expanded configuration to bridge the aperture, thereby occluding the aperture and preventing the migration of nucleus pulposus therethrough.
  • The objects and various advantages of the invention will be apparent in consideration of the description which follows. In general, the implantable medical device is placed, positioned, and affixed to the annulus to reduce re-extrusion of the nucleus through the aperture by: acting as a mechanical barrier; restoring the natural integrity of the wall of the annulus; and promoting the healing of the annulus through the reapproximation of disc wall tissue. Increased integrity and faster and/or more thorough healing of the aperture is intended to reduce future recurrence of herniation of the disc nucleus from the intervertebral disc, and the recurrence of resulting back pain. In addition, it is believed that the repair of the aperture could promote enhanced biomechanics and reduce the possibility of intervertebral disc height collapse and segmental instability, thus resulting in a decrease in the recurrence of back pain after a surgical procedure.
  • Moreover, the repair of the aperture with the reduction of the re-extrusion of the nucleus may also advantageously reduce adhesion formation surrounding the nerve roots. The nuclear material of the disc is toxic to the nerves and is believed to cause increased inflammation surrounding the nerves, which in turn can cause increased scar formation (adhesions or epidural fibrosis) upon healing. Adhesions created around the nerve roots can cause continued back pain. Any reduction in adhesion formation is believed to reduce future recurrence of pain.
  • One of the objects of the present inventions is to act as a mechanical barrier to the extrusion of the nucleus from the disc space, add mechanical integrity to the annulus and the tissue surrounding the aperture, and to promote faster and a more complete healing of the aperture.
  • Although much of the discussion is directed toward the repair of the intervertebral disc after a surgical procedure, such as discectomy (a surgical procedure performed to remove herniated fragments of the disc nucleus), it is contemplated that the device could be used in other procedures that involve incisions into the annulus of the intervertebral disc. An example of another procedure that could require a repair technique involves the replacement of the nucleus—nucleus replacement—with an implantable nucleus to replace the functioning of the natural nucleus when it is degenerated. The object of the invention in this case would be similar in that the repair would maintain the replacement nucleus within the disc space.
  • According to the invention, a sub-annular patch/stent can be employed to repair an intervertebral disc annulus. In its simplest form, the repair of the annulus involves the placement and fixation of a fascial autograft patch to the sub-annular space which can additionally employ two or more sutures, while re-approximating the tissues surrounding the aperture. The invention, through involvement of the sub-annular space and wall for the repair of the aperture, has several advantages over the prior art; for example, sealing the aperture only on the outer surface, or sealing the aperture only within the aperture. The first advantage of a repair that involves the sub-annular surface derives itself from the physical nature of a circular (or an elliptical) compressed chamber with a radius, like an intervertebral disc. Sealing the inside wall has the inherent advantage of being at a smaller radius of curvature versus the outer wall and thus, according to LaPlace's Law, the patch would be subjected to lower stresses at any given pressure, all else held equal.
  • Another advantage of utilizing the inner surface to accomplish sealing is that the natural pressure within the disc can enhance the sealing of the device against the inner wall of the disc space. Conversely, if the repair is performed on the outer surface of the annulus there is an inherent risk of leakage around the periphery of the device, with the constant exposure to the pressure of the disc.
  • Another advantage of the present invention over the prior art in utilizing the inner surface of the annulus is the reduction of the risk of having a portion of the device protruding from the exterior surface of the annulus. Device materials protruding from the exterior of the annulus pose a risk of damaging the nerve root and/or spinal canal which are in close proximity. Damage to these structures can result in continued pain, incontinence, bowel dysfunction, and paralysis.
  • The present invention also incorporates the concept of pulling the tissues together that surround the aperture, the inner surface, and the outer surface of the annulus to help increase the integrity of the repair.
  • An example of the technique and placement of the device according to the invention is as follows:
  • 1. An aperture is created measuring approximately, for example, 6 mm×2 mm in the wall of the annulus after performing a discectomy procedure in which a portion of the nucleus is also removed from the disc space, as shown in FIGS. 32 a, 32 b, 33 a and 33 b.
  • 2. Two or more sutures are passed through the upper and lower surfaces of the aperture and they are pushed within the intervertebral disc space to create a “sling” to receive the fascial autograft as shown for example in FIG. 34.
  • 3. A piece of para-spinal fascial tissue is removed from the patient measuring approximately, for example, 10 mm×5 mm.
  • 4. The autograft is folded and compressed to pass through the aperture in the annulus, as shown for example in FIG. 35.
  • 5. The autograft takes a second shape, within the annulus that is uncompressed and oriented to be in proximity of the subannular wall of the annulus, within the sling, as shown for example in FIG. 36. The autograft may be inserted entirely into the subannular space, or a portion may extend into the rent as depicted in FIG. 36.
  • 6. The sutures are tightened, as shown for example in FIG. 37, thus tightening the sling surrounding the autograft, to bring the autograft in close proximity with the subannular wall, while providing tension to bring the patch at the subannular surface together with the outer surface of the annular wall, thus creating increased integrity of the annulus surrounding the aperture, as well as causing the autograft to take a second shape that is larger than the aperture. Furthermore, the tightening, and eventual tying of the sutures also promotes the re-approximation of the tissue at the outer surface of the annulus and within the aperture.
  • 7. The sutures are tied and the ends of the sutures are cut.
  • 8. A piece of autograft fat tissue may be placed over the discectomy site for the prevention of adhesion formation, a typical surgical technique.
  • 9. Standard surgical techniques are utilized to close the access site of the surgical procedures.
  • Several devices according to the present invention can be used to practice the above illustrative inventive steps to accomplish the sealing and/or repair of the intervertebral disc. In each of the representative devices described herein, there is: an expandable patch/stent (note: patch, stent and device are used interchangeably) that has, in use, at least a portion of the device in proximity to the sub-annular space of the intervertebral disc annulus; a means to affix the patch to stay in proximity with the annulus; a means to draw the patch and the annular tissue together and fasten in tension; and a means to help reduce the relative motion of the surfaces of the aperture after fixation, and thus promote healing. According to one feature and object of the present invention, close approximation of tissue, while reducing the motion of the surfaces, provides the optimal environment for healing.
  • The concepts disclosed hereinbelow accomplish these objectives, as well as advantageously additionally incorporating design elements to reduce the number of steps (and time), and/or simplify the surgical technique, and/or reduce the risk of causing complications during the repair of the intervertebral disc annulus. In addition, it is an objective of the following devices to become incorporated by the surrounding tissues, or to act as a scaffold in the short-term (3-6 months) for tissue incorporation.
  • In an exemplary embodiment, one or more mild biodegradable surgical sutures can be placed at about equal distances along the sides of a pathologic aperture in the ruptured disc wall (annulus) or along the sides of a surgical incision in the annular wall, which may be weakened or thinned.
  • Sutures are then tied in such fashion as to draw together the sides of the aperture, effecting reapproximation or closure of the opening, to enhance natural healing and subsequent reconstruction by natural tissue (fibroblasts) crossing the now surgically narrowed gap in the disc annulus.
  • A 25-30% reduction in the rate of recurrence of disc nucleus herniation through this aperture has been achieved using this method.
  • In another exemplary embodiment, the method can be augmented by creating a subannular barrier in and across the aperture by placement of a patch of human muscle fascia (muscle connective tissue) or any other autograft, allograft, or xenograft acting as a bridge or a scaffold, providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus, prior to closure of the aperture.
  • A 30-50% reduction in the rate of recurrence of disc herniation has been achieved using the aforementioned fascial augmentation with this embodiment.
  • In still another embodiment, a braided patch can be formed having a first collapsed configuration having a major longitudinal dimension with first and second ends. When these ends are moved toward each other along the longitudinal axis, a portion of the device between the ends can deploy outwardly to form an expanded configuration.
  • Having demonstrated that human muscle fascia is adaptable for annular reconstruction, other biocompatible membranes can be employed as a bridge, stent, patch or barrier to subsequent migration of the disc nucleus through the aperture. Such biocompatible materials may be, for example, medical grade biocompatible fabrics, biodegradable polymeric sheets, or form fitting or non-form fitting fillers for the cavity created by removal of a portion of the disc nucleus pulposus in the course of the disc fragment removal or discectomy. The prosthetic material can be placed in and around the intervertebral space, created by removal of the degenerated disc fragments.
  • Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
  • It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate illustrative embodiments of the invention and, together with the description, serve to explain the principles of the invention.
  • FIG. 1 shows a perspective view of an illustrative embodiment of an annulus stent.
  • FIG. 2 shows a front view of the annulus stent of FIG. 1.
  • FIG. 3 shows a side view of the annulus stent of FIG. 1.
  • FIGS. 4A-4C show a front view of alternative illustrative embodiments of an annulus stent.
  • FIGS. 5A-5B show the alternative embodiment of a further illustrative embodiment of an annulus stent.
  • FIGS. 6A-6B show the alternative embodiment of a further illustrative embodiment of an annulus stent.
  • FIG. 7 shows a primary closure of an opening in the disc annulus.
  • FIGS. 8A-8B show a primary closure with a stent.
  • FIG. 9 shows a method of suturing an annulus stent into the disc annulus utilizing fixation points on vertebral bodies.
  • FIGS. 10A-10B show a further illustrative embodiment of an annulus stent with flexible bladder being expanded into the disc annulus.
  • FIGS. 11A-11D show an annulus stent being inserted into and expanded within the disc annulus.
  • FIGS. 12A-12B show an annulus stent with a flexible bladder being expanded.
  • FIG. 13 shows a perspective view of a further illustrative embodiment of an annulus stent.
  • FIG. 14 shows a first collapsed view of the annulus stent of FIG. 13.
  • FIG. 15 shows a second collapsed view of the annulus stent of FIG. 13.
  • FIGS. 16A-16C show the annulus stent of FIG. 13 being inserted into the disc annulus.
  • FIGS. 17A-17C show a method of inserting the annulus stent of FIG. 13 into the disc annulus.
  • FIGS. 18A-18B show a further illustrative embodiment of an annulus stent with a flexible bladder.
  • FIGS. 19A-19B show another illustrative embodiment of an annulus stent with a flexible bladder.
  • FIG. 20 shows an expanded annulus stent with barbs on the radial extension.
  • FIG. 21 shows a still further illustrative embodiment of an annulus stent with a compressible core.
  • FIG. 22 shows a still further illustrative embodiment of an introduction device for an annulus stent.
  • FIG. 23 shows a modification of the device depicted in FIG. 22.
  • FIG. 24 shows an exemplary introduction tool for use with the devices of FIGS. 22 and 23 with a stent deflected proximally.
  • FIG. 25 shows an exemplary introduction tool for use with the devices of FIGS. 22 and 23 with a stent deflected distally.
  • FIG. 26 shows an exemplary introduction tool for use with the devices of FIGS. 22 and 23 with a stent deflected partially distally and partially proximally.
  • FIG. 27 shows a still further illustrative embodiment of a stent device having a grasping feature and fixation devices in the form of barbs.
  • FIG. 28 shows the illustrative embodiment in FIG. 27 deployed subannularly.
  • FIG. 29 shows a still further illustrative embodiment of an annulus stent employing a secondary barbed fixation device.
  • FIG. 30 shows a still further illustrative embodiment of an annulus stent employing another example of a secondary barbed fixation device.
  • FIG. 31 shows the frame of a still further illustrative embodiment of an annulus stent having a metal substrate being machined from flat stock.
  • FIG. 32 a shows a herniated disc in perspective view, and FIG. 32 b shows the same disc after discectomy.
  • FIG. 33 a shows a top view of the disc post-discectomy, and FIG. 33 b shows a posteriolateral view of the disk showing an incision.
  • FIG. 34 shows schematically the creation of a subannular sling using sutures.
  • FIG. 35 schematically shows the introduction of a compressed autograft stent/patch into the subannular space.
  • FIG. 36 schematically shows the autograft of FIG. 35 in an expanded shape within the annulus.
  • FIG. 37 schematically shows the tightening of the sutures to reapproximate the annulus aperture and draw the stent/patch of FIG. 35 toward the annular wall.
  • FIG. 38 shows an exemplary collar for use in repairing a disc annulus.
  • FIG. 39 schematically depicts the collar of FIG. 38 in use for disc annulus repair.
  • FIG. 40 shows a still further exemplary embodiment of the present invention using a bag to contain the patch/stent.
  • FIG. 41 a-e show still further illustrative embodiments of the present invention having frames.
  • FIG. 42 shows an illustrative method for placing a barbed expandable patch in the subannular disc space.
  • FIG. 43 shows the patch of FIG. 42 being fixed to the inside wall of the annulus fibrosus.
  • FIGS. 44 a-g show a still further illustrative embodiment of an introduced and expanded annulus stent/patch being fixated and the aperture reapproximated.
  • FIGS. 45 a-c schematically depict a still further embodiment of the present invention where an expandable stent/patch is tethered in situ using a cinch line.
  • FIGS. 46 a-c schematically depict the cinch line of FIG. 45 being fixated through use of a surgical staple device.
  • FIGS. 47 a-b show an illustrative embodiment of a suturing arrangement for securing a patch/stent in the annulus.
  • FIG. 48 a-b depict a still further illustrative embodiment where fixation sutures are placed into the vertebral body or the Sharpey fibers.
  • FIGS. 49 a-c schematically depict a still further embodiment of the present invention where an expandable stent/patch is tethered in situ using a cinch line.
  • FIGS. 50 a-c schematically depict the cinch line of FIG. 49 being fixated through use of a barbed surgical staple device that penetrates the patch/stent.
  • FIG. 51 depicts an exemplary use of filler tissue within the aperture during placement of a patch/stent tethered by a cinch line.
  • FIGS. 52 a-e shows exemplary embodiments of various additional patch/stent fixation techniques.
  • FIG. 53 shows a still further illustrative embodiment of a stent/patch having a frame.
  • FIG. 54 a-f shows a still further illustrative embodiment of an annular stent/patch having a self-contained fixation tightening feature.
  • FIG. 55 shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 56 a-c shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 57 a-c shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 58 shows a still further exemplary embodiment of the present invention having external fixation anchors.
  • FIG. 59 shows a still further exemplary embodiment of the present invention having a springing arrangement.
  • FIG. 60 shows a lateral view of a still further exemplary embodiment of the present invention having a braided arrangement in a collapsed configuration.
  • FIG. 61 shows an axial view of the exemplary embodiment of FIG. 60 in an expanded configuration.
  • FIG. 62 shows a lateral view of the exemplary embodiment of FIG. 60 in a collapsed configuration mounted on an illustrative delivery device.
  • FIG. 63 shows a lateral cutaway view of the exemplary embodiment of FIG. 60 in a collapsed configuration.
  • FIG. 64 shows a lateral cutaway view of the exemplary embodiment of FIG. 60 in an expanded configuration.
  • FIG. 65 shows a lateral view of an illustrative delivery member as shown in the exemplary embodiment of FIGS. 63 and 64.
  • FIG. 66 shows a lateral view of an exemplary embodiment of the invention in an expanded configuration subannularly.
  • DETAILED DESCRIPTION OF THE INVENTION
  • Reference will now be made in detail to an illustrative embodiment of the invention, which appears in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
  • In one embodiment of the present invention, as shown in FIG. 7, a damaged annulus 42 is repaired by use of surgical sutures 40. One or more surgical sutures 40 are placed at about equal distances along the sides of a pathologic aperture 44 in the annulus 42. Reapproximation or closure of the aperture 44 is accomplished by tying the sutures 40 so that the sides of the aperture 44 are drawn together. The reapproximation or closure of the aperture 44 enhances the natural healing and subsequent reconstruction by the natural tissue (e.g., fibroblasts) crossing the now surgically narrowed gap in the annulus 42. Preferably, the surgical sutures 40 are biodegradable, but permanent non-biodegradable may be utilized.
  • Additionally, to repair a weakened or thinned wall of a disc annulus 42, a surgical incision can be made along the weakened or thinned region of the annulus 42 and one or more surgical sutures 40 can be placed at about equal distances laterally from the incision. Reapproximation or closure of the incision is accomplished by tying the sutures 40 so that the sides of the incision are drawn together. The reapproximation or closure of the incision enhances the natural healing and subsequent reconstruction by the natural tissue crossing the now surgically narrowed gap in the annulus 42. Preferably, the surgical sutures 40 are biodegradable, but permanent non-biodegradable materials may be utilized.
  • In an alternative embodiment, the method can be augmented by the placement of a patch of human muscle fascia or any other autograft, allograft or xenograft in and across the aperture 44. The patch acts as a bridge in and across the aperture 44, providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus 42, prior to closure of the aperture 44.
  • In a further embodiment, as shown in FIGS. 8A-B a biocompatible membrane can be employed as an annulus stent 10, being placed in and across the aperture 44. The annulus stent 10 acts as a bridge in and across the aperture 44, providing a platform for a traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus 42, prior to closure of the aperture 44. In some embodiments the device, stent or patch can act as a scaffold to assist in tissue growth that healingly scars the annulus.
  • In an illustrative embodiment, as shown in FIGS. 1-3, the annulus stent 10 comprises a centralized vertical extension 12, with an upper section 14 and a lower section 16. The centralized vertical extension 12 can be trapezoid in shape through the width and may be from about 8 mm-12 mm in length.
  • Additionally, the upper section 14 of the centralized vertical extension 12 may be any number of different shapes, as shown in FIGS. 4A through 4C, with the sides of the upper section 14 being curved or with the upper section 14 being circular in shape. Furthermore, the annulus stent 10 may contain a recess between the upper section 14 and the lower section 16, enabling the annulus stent 10 to form a compatible fit with the edges of the aperture 44.
  • The upper section 14 of the centralized vertical extension 12 can comprise a slot 18, where the slot 18 forms an orifice through the upper section 14. The slot 18 is positioned within the upper section 14 such that it traverses the upper section's 14 longitudinal axis. The slot 18 is of such a size and shape that sutures, tension bands, staples or any other type of fixation device known in the art may be passed through, to affix the annulus stent 10 to the disc annulus 42.
  • In an alternative embodiment, the upper section 14 of the centralized vertical extension 12 may be perforated. The perforated upper section 14 contains a plurality of holes that traverse the longitudinal axis of upper section 14. The perforations are of such a size and shape that sutures, tension bands, staples or any other type of fixation device known in the art may be passed through, to affix the annulus stent 10 to the disc annulus 42.
  • The lower section 16 of the centralized vertical extension 12 can comprise a pair of lateral extensions, a left lateral extension 20 and a right lateral extension 22. The lateral extensions 20 and 22 comprise an inside edge 24, an outside edge 26, an upper surface 28, and a lower surface 30. The lateral extensions 20 and 22 can have an essentially constant thickness throughout. The inside edge 24 is attached to and is about the same length as the lower section 16. The outside edge 26 can be about 8 mm-16 mm in length. The inside edge 24 and the lower section 16 meet to form a horizontal plane, essentially perpendicular to the centralized vertical extension 12. The upper surface 28 of the lateral extensions 20 and 22 can form an angle from about 0°-60° below the horizontal plane. The width of the annulus stent 10 may be from about 3 mm-8 mm.
  • Additionally, the upper surface 28 of the lateral extensions 20 and 22 may be barbed for fixation to the inside surface of the disc annulus 42 and to resist expulsion through the aperture 44.
  • In an alternative embodiment, as shown in FIG. 4B, the lateral extensions 20 and 22 have a greater thickness at the inside edge 24 than at the outside edge 26.
  • In an illustrative embodiment, the annulus stent 10 is a solid unit, formed from one or more of the flexible resilient biocompatible or bioresorbable materials well know in the art. The selection of appropriate stent materials may be partially predicated on specific stent construction and the relative properties of the material such that, after fixed placement of the stent, the repair may act to enhance the healing process at the aperture by relatively stabilizing the tissue and reducing movement of the tissue surrounding the aperture.
  • For example, the annulus stent 10 may be made from:
  • A porous matrix or mesh of biocompatible and bioresorbable fibers acting as a scaffold to regenerate disc tissue and replace annulus fibrosus as disclosed in, for example, U.S. Pat. No. 5,108,438 (Stone) and U.S. Pat. No. 5,258,043 (Stone), a strong network of inert fibers intermingled with a bioresorbable (or bioabsorbable) material which attracts tissue ingrowth as disclosed in, for example, U.S. Pat. No. 4,904,260 (Ray et al.).
  • a biodegradable substrate as disclosed in, for example, U.S. Pat. No. 5,964,807 (Gan at al.); or
  • an expandable polytetrafluoroethylene (ePTFE), as used for conventional vascular grafts, such as those sold by W.L. Gore and Associates, Inc. under the trademarks GORE-TEX and PRECLUDE, or by Impra, Inc. under the trademark IMPRA.
  • Furthermore, the annulus, stent 10, may contain hygroscopic material for a controlled limited expansion of the annulus stent 10 to fill the evacuated disc space cavity.
  • Additionally, the annulus stent 10 may comprise materials to facilitate regeneration of disc tissue, such as bioactive silica-based materials that assist in regeneration of disc tissue as disclosed in U.S. Pat. No. 5,849,331 (Ducheyne, et al.), or other tissue growth factors well known in the art.
  • Many of the materials disclosed and described above represent embodiments where the device actively promotes the healing process. It is also possible that the selection of alternative materials or treatments may modulate the role in the healing process, and thus promote or prevent healing as may be required. It is also contemplated that these modulating factors could be applied to material substrates of the device as a coating, or similar covering, to evoke a different tissue response than the substrate without the coating.
  • In further embodiments, as shown in FIGS. 5AB-6AB, the left and right lateral extensions 20 and 22 join to form a solid pyramid or cone. Additionally, the left and right lateral extensions 20 and 22 may form a solid trapezoid, wedge, or bullet shape. The solid formation may be a solid biocompatible or bioresorbable flexible material, allowing the lateral extensions 20 and 22 to be compressed for insertion into aperture 44, then to expand conforming to the shape of the annulus' 42 inner wall.
  • Alternatively, a compressible core may be attached to the lower surface 30 of the lateral extensions 20 and 22, forming a pyramid, cone, trapezoid, wedge, or bullet shape. The compressible core may be made from one of the biocompatible or bioresorbable resilient foams well known in the art. The core can also comprise a fluid-expandable membrane, e.g., a balloon. The compressible core allows the lateral extensions 20 and 22 to be compressed for insertion into aperture 44, then to expand conforming to the shape of the annulus' 42 inner wall and to the cavity created by pathologic extrusion or surgical removal of the disc fragment.
  • In an illustrative method of use, as shown in FIGS. 11A-D, the lateral extensions 20 and 22 are compressed together for insertion into the aperture 44 of the disc annulus 42. The annulus stent 10 is then inserted into the aperture 44, where the lateral extensions 20, 22 expand. In an expanded configuration, the upper surface 28 can substantially conform to the contour of the inside surface of the disc annulus 42. The upper section 14 is positioned within the aperture 44 so that the annulus stent 10 may be secured to the disc annulus 42, using means well known in the art.
  • In an alternative method, where the length of the aperture 44 is less than the length of the outside edge 26 of the annulus stent 10, the annulus stent 10 can be inserted laterally into the aperture 44. The lateral extensions 20 and 22 are compressed, and the annulus stent 10 can then be laterally inserted into the aperture 44. The annulus stent 10 can then be rotated inside the disc annulus 42, such that the upper section 14 can be held back through the aperture 44. The lateral extensions 20 and 22 are then allowed to expand, with the upper surface 28 contouring to the inside surface of the disc annulus 42. The upper section 14 can be positioned within, or proximate to, the aperture 44 in the subannular space such that the annulus stent 10 may be secured to the disc annulus, using means well known in the art.
  • In an alternative method of securing the annulus stent 10 in the aperture 44, as shown in FIG. 9, a first surgical screw 50 and second surgical screw 52, with eyeholes 53 located at the top of the screws 50 and 52, are inserted into the vertebral bodies, illustratively depicted as adjacent vertebrae 54 and 56. After insertion of the annulus stent 10 into the aperture 44, a suture 40 is passed down though the disc annulus 42, adjacent to the aperture 44, through the eye hole 53 on the first screw 50 then back up through the disc annulus 42 and through the orifice 18 on the annulus stent 10. This is repeated for the second screw 52, after which the suture 40 is secured. One or more surgical sutures 40 are placed at about equal distances along the sides of the aperture 44 in the disc annulus 42. Reapproximation or closure of the aperture 44 is accomplished by tying the sutures 40 in such a fashion that the sides of the aperture 44 are drawn together. The reapproximation or closure of the aperture 44 enhances the natural healing and subsequent reconstruction by the natural tissue crossing the now surgically narrowed gap in the annulus 42. Preferably, the surgical sutures 40 are biodegradable but permanent non-biodegradable forms may be utilized. This method should decrease the strain on the disc annulus 42 adjacent to the aperture 44, precluding the tearing of the sutures through the disc annulus 42.
  • It is anticipated that fibroblasts will engage the fibers of the polymer or fabric of the intervertebral disc stent 10, forming a strong wall duplicating the currently existing condition of healing seen in the normal reparative process.
  • In an additional embodiment, as shown in FIGS. 1A-B, a flexible bladder 60 is attached to the lower surface 30 of the annulus stent 10. The flexible bladder 60 comprises an internal cavity 62 surrounded by a membrane 64, where the membrane 64 is made from a thin flexible biocompatible material. The flexible bladder 60 is attached to the lower surface 30 of the annulus stent 10 in an unexpanded condition. The flexible bladder 60 is expanded by injecting a biocompatible fluid or expansive foam, as known in the art, into the internal cavity 62. The exact size of the flexible bladder 60 can be varied for different individuals. The typical size of an adult nucleus is about 2 cm in the semi-minor axis, 4 cm in the semi-major axis, and 1.2 cm in thickness.
  • In an alternative embodiment, the membrane 64 is made of a semi-permeable biocompatible material. The mechanical properties of the injectate material may influence the performance of the repair and it is contemplated that materials which are “softer” or more compliant as well as materials that are less soft and less compliant than healthy nucleus are contemplated within the scope of certain embodiments of the invention. It must be understood that in certain embodiments the volume added to the subannular space may be less than equal to or larger than the nucleus volume removed. The volume of the implant may vary over time as well in certain embodiments.
  • In an illustrative embodiment, a hydrogel is injected into the internal cavity 62 of the flexible bladder 60. A hydrogel is a substance formed when an organic polymer (natural or synthetic) is cross-linked via, covalent, ionic, or hydrogen bonds to create a three-dimensional open-lattice structure, which entraps water molecules to form a gel. The hydrogel may be used in either the hydrated or dehydrated form.
  • In a method of use, where the annulus stent 10 has been inserted into the aperture 44, as has been previously described and shown in FIGS. 12 A-B, an injection instrument, as known in the art, such as a syringe, is used to inject the biocompatible fluid or expansive foam into the internal cavity 62 of the flexible bladder 60. The biocompatible fluid or expansive foam is injected through the annulus stent 10 into the internal cavity 62 of the flexible bladder 60. Sufficient material is injected into the internal cavity 62 to expand the flexible bladder 60 to fill the void in the intervertebral disc cavity. The use of the flexible bladder 60 is particularly useful when it is required to remove all or part of the intervertebral disc nucleus.
  • The surgical repair of an intervertebral disc may require the removal of the entire disc nucleus, being replaced with an implant, or the removal of a portion of the disc nucleus thereby leaving a void in the intervertebral disc cavity. The flexible bladder 60 allows for the removal of only the damaged section of the disc nucleus, with the expanded flexible bladder 60 filling the resultant void in the intervertebral disc cavity. A major advantage of the annulus stent 10 with the flexible bladder 60 is that the incision area in the annulus 42 can be reduced in size, as there is no need for the insertion of an implant into the intervertebral disc cavity.
  • In an alternative method of use, a dehydrated hydrogel is injected into the internal cavity 62 of the flexible bladder 60. Fluid, from the disc nucleus, passes through the semipermeable membrane 64 hydrating the dehydrated hydrogel. As the hydrogel absorbs the fluid the flexible bladder 60 expands, filling the void in the intervertebral disc cavity.
  • In an alternative embodiment, as shown in FIG. 13, the annulus stent 10 is substantially umbrella shaped, having a central hub 66 with radially extending struts 67. Each of the struts 67 is joined to the adjacent struts 67 by a webbing material 65, forming a radial extension 76 about the central hub 66. The radial extension 76 has an upper surface 68 and a lower surface 70, where the upper surface 68 contours to the shape of the disc annulus' 42 inner wall when inserted as shown in FIG. 17A-C, and where the lower surface 70 contours to the shape of the disc annulus' 42 inner wall when inserted as shown in FIG. 16A-C. The radial extension 76 may be substantially circular, elliptical, or rectangular in plan shape. Additionally, as shown in FIG. 20, the upper surface 68 of the radial extension 76 may be barbed 82 for fixation to the disc annulus' 42 inner wall and to resist expulsion through the aperture 42.
  • As shown in FIGS. 14 and 15, the struts 67 are formed from flexible material, allowing the radial extension 76 to be collapsed for insertion into aperture 44, then the expand conforming to the shape of the inner wall of disc annulus 42. In the collapsed position, the annulus stent 10 is substantially frustoconical or shuttlecock shaped, and having a first end 72, comprising the central hub 66, and a second end 74.
  • In an alternative embodiment, the radial extension 76 has a greater thickness at the central hub 66 edge than at the outside edge.
  • In an embodiment, the annulus stent 10 is a solid unit, formed from one or more of the flexible resilient biocompatible or bioresorbable materials well known in the art.
  • Additionally, the annulus stent 10 may comprise materials to facilitate regeneration of disc tissue, such as bioactive silica based materials that assist in regeneration of disc tissue as disclosed in U.S. Pat. No. 5,849,331 (Ducheyne, et al.), or other tissue growth factors well known in the art.
  • Alternatively, as shown in FIG. 21, a compressible core 84 may be attached to the lower surface 70 of the radial extension 76. The compressible core 84 may be made from one of the biocompatible or bioresorbable resilient foams well known in the art. The compressible core 84 allows the radial extension 76 to be compressed for insertion into aperture 44 then to expand conforming to the shape of the disc annulus' 42 inner wall and to the cavity created by pathologic extrusion or surgical removal of the disc fragment.
  • In an additional embodiment, as shown in FIGS. 18A and 18B, a flexible bladder 80 is attached to the lower surface 70 of the annulus stent 10. The flexible bladder 80 comprises an internal cavity 86 surrounded by a membrane 88, where the membrane 88 is made from a thin flexible biocompatible material. The flexible bladder 86 is attached to the lower surface 70 of the annulus stent 10 in an unexpanded condition. The flexible bladder 80 is expanded by injecting a biocompatible fluid or expansive foam, as known in the art, into the internal cavity 86. The exact size of the flexible bladder 80 can be varied for different individuals. The typical size of an adult nucleus is 2 cm in the semi-minor axis, 4 cm in the semi-major axis and 1.2 cm in thickness.
  • In an alternative embodiment, the membrane 88 is made of a semi-permeable biocompatible material.
  • In a method of use, as shown in FIGS. 16A-16C, the radial extension 76 is collapsed together, for insertion into the aperture 44 of the disc annulus 42. The radial extension 76 is folded such the upper surface 68 forms the outer surface of the cylinder. The annulus stent 10 is then inserted into the aperture 44, inserting the leading end 72 though the aperture 44 until the entire annulus stent 10 is within the disc annulus 42. The radial extension 76 is released, expanding within the disc 44. The lower surface 70 of the annulus stent 10 contours to the inner wall of disc annulus 42. The central hub 66 is positioned within the aperture 44 so that the annulus stent 10 may be secured to the disc annulus 42 using means well known in the art.
  • It is anticipated that fibroblasts will engage the fibers of the polymer of fabric of the annulus stent 10, forming a strong wall duplicating the currently existing condition of healing seen in the normal reparative process.
  • In an alternative method of use, as shown in FIGS. 17A-17C, the radial extension 76 is collapsed together for insertion into the aperture 44 of the disc annulus 42. The radial extension 76 is folded such that the upper surface 68 forms the outer surface of the stent, for example in a frustoconical configuration as illustrated. The annulus stent 10 is then inserted into the aperture 44, inserting the tail end 74 through the aperture 44 until the entire annulus stent 10 is in the disc. The radial extension 76 is released, expanding within the disc. The upper surface 68 of the annulus stent 10 contours to the disc annulus' 42 inner wall. The central hub 66 is positioned within the aperture 44 so that the annulus stent 10 may be secured to the disc annulus 42, using means well known in the art.
  • In one illustrative embodiment, the barbs 82 on the upper surface 68 of one or more strut 67 or other feature of the radial extension 76, engage the disc annulus' 42 inner wall, holding the annulus stent 10 in position.
  • In a method of use, as shown in FIGS. 12A-12B, where the annulus stent 10 has been inserted into the aperture 44, as has been previously described. Similarly, for the stent shown in FIGS. 18 through 21, an injection instrument, as known in the art, such as a syringe, can be used to inject the biocompatible fluid or expansive foam into the internal cavity 86 of the flexible bladder 80. The biocompatible fluid or expansive foam is injected through the annulus stent 10 into the internal cavity 86 of the flexible bladder 80. Sufficient material is injected into the internal cavity 86 to expand the flexible bladder 80 to fill the void in the intervertebral disc cavity. The material can be curable (i.e., glue). The use of the flexible bladder 80 is particularly useful when it is required to remove all or part of the intervertebral disc nucleus.
  • It should be noted that in any of the “bag” embodiments described herein one wall or barrier can be made stiffer and less resilient than others. This relatively stiff wall member can then be placed proximate the annulus wall and can advantageously promote, in addition to its reparative properties, bag containment within the annulus.
  • FIG. 22 shows a further aspect of the present invention. According to a further illustrative embodiment, a simplified schematic cross section of a vertebral pair is depicted including an upper vertebral body 110, a lower vertebral body 112 and an intervertebral disc 114. An aperture or rent 116 in the annulus fibrosus (AF) is approached by a tube 118, which is used to deliver a device 120 according to a further aspect of the present invention. The device 120 may be captured by a delivery tool 122 through the use of a ring or other fixation feature 124 mounted on the repair device 120.
  • FIG. 23 shows a delivery method similar to that depicted in FIG. 22, with the exception that the tube 118A has a reduced diameter so that it may enter into the sub-annular space of the disc 114 through the aperture or rent.
  • Turning to FIG. 25, according to a further aspect of the present invention, the delivery of the device 120 through the delivery tube 118 or 118A may be facilitated by folding the arms or lateral extensions 128, 130 of the device to fit within the lumen of the tube 118 or 118A so that the stent or device 120 is introduced in a collapsed configuration. The device 120 is moved through the lumen of the tubes 118 or 118A through the use of delivery tool 122. FIG. 25 shows the arms deflected in a distal, or forward direction for insertion into the delivery tube 118 or 118A while FIG. 24 shows the arms 128, 130 deflected into a proximal position. FIG. 26 shows the device 120 curled so that one arm 128 is projecting distally, or in a forward direction, and the other arm 130 is projecting proximally, or in a rearward direction. Because the lateral extent of the device is relatively flexible, whether the device is of natural or synthetic material, other collapsible configurations consistent with the intent of this invention are also possible, including twisting, balling, crushing, etc.
  • FIG. 27 shows the device 120 having a series of peripheral barb structures typified by barb 132 located at the edges. In operation, these barbs may be forced into the annulus fibrosus as seen in connection with FIG. 28. Barb placement can be anywhere on the device 120 provided that at least some number of barbs are likely to find annulus fibrosus tissue to anchor in during placement. For a simple aperture or rent, placement on the periphery of the device body is a reasonable choice, but for complex tears, it may be desirable to place a plurality of barbs on the device not knowing in advance which barbs will find tissue to anchor in during placement.
  • FIG. 29 shows an alternative fixation strategy where a pair of barbs 134 and 136 are plunged into the annulus fibrosus from the exterior of the annulus while the device 120 is retained in the sub-annular space by means of a tether 142. Although there are a wide variety of fixation devices in this particular example, a tether 142 may be knotted 145 with the band 144 holding the barbs 134 and 136 together to fix the device in the sub-annular space. The knot is shown in an uncinched position to clarify the relationship between the tether 142 and the bands 144. Using this approach, the device can be maintained in a subannular position by the barbed bands while the tether knot is cinched, advantageously simultaneously reapproximating the annulus to close the aperture while drawing the device into sealing, bridging engagement with the subannular wall of the annulus fibrosus.
  • FIG. 30 shows an alternative fixation strategy where the barbs 148 and 150 are sufficiently long that they can pierce the body of the device 120 and extend all the way through the annulus fibrosus into the device 120. In this configuration, the band 144 connecting the barbs 148 and 150 may be tightened to gently restrain and position the device 120 in the sub-annular space, or tightened with greater force to reapproximate the aperture or rent.
  • FIG. 31 shows a still further illustrative embodiment according to another aspect of the present invention. In this embodiment, a metal substrate 160 is incorporated into the device 120. This piece can be machined from flat stock and includes the loop 162 as well as barbs typified by barb 164. When formed in to the device 120 the structure shown in FIG. 31 is used in a manner analogous to FIG. 27 and FIG. 28.
  • Stents can expand to be planar, for example as shown hereinabove in FIGS. 4, 8, 9, 11 and 12, or they can expand to be three-dimensional as shown hereinabove in FIGS. 5 and 10. FIGS. 34-36 depict a further three dimensional patch/stent using an autograft formed of fascial tissue. FIG. 34 shows the superior vertebral body 202 and the inferior vertebral body 204 surrounding a disc having an annulus fibrosus 206 and nucleus pulposus 203 in the subannular space. According to this illustrative embodiment of the invention, a suture 210 is passed from outside the annulus through the wall of the annulus on one side of an aperture 208 and into the subannular space as shown. The suture is then passed back out through the annular wall on an opposing side of the aperture 208 leaving a loop or sling 212 of suture in the subannular space. As shown in the posterior view on the right side of FIG. 34, more than one suture can be applied. Turning to FIG. 35, a fascial autograft 214 is then inserted through the aperture 208 into the subannular space using, for example, forceps 216. FIG. 36 shows the fascial stent/patch 214 fully inserted into the subannular space within the suture sling 212. The closure of the aperture is accomplished simultaneously with pulling the autograft 214 toward the annular wall as shown in FIG. 37. The suture 210 can be cinched 218 or tied to maintain the closure and the fixation of the patch/stent.
  • Patches can be folded and expanded in a single plane or in three dimensions. As shown in FIGS. 24-25 and 41 for example, collapsing the patch can be accomplished laterally, whether the device is a single material or composite. Other embodiments, such as that shown in FIG. 1 can collapse vertically, and still others such as that shown in FIG. 26, longitudinally. Others can collapse in three dimensions, such as those shown in FIGS. 13-15 and 36. Devices which expand in three dimensions can be packaged in a restraining jacket, such as a gelatine shell or “gelcap” for example, or a mesh of biosorbable or dissolvable material, that would allow for facile placement and subsequent expansion.
  • Patches can also be constructed of a single component, as shown for example in FIG. 36, made of autograft or a synthetic material such as Dacron, or for example where the stent is a gelcap. They can be made of multiple components. An exemplary stent (not shown) can be made from a polymeric material, for example silicone rubber, which can be formed to have a natural unstressed shape, for example that of a “Bulb”. A stylet or push-rod can, for example, be inserted on the inside of the bulb to stretch the bulb into a second shape which is thinner and elongated. The second shape is sufficient to place within the aperture in the annulus. Upon placement of the device within the sub-annular space, the push-rod is removed and the bulb assumes it natural, unstressed state, assuming a larger dimension within the sub-annular space. Although silicone is used in this example, other metallic constructs could also be envisioned such as a Nitinol braided device that has a natural unstressed shape and assumes a second shape under tension for the delivery of the device. It is also contemplated that the opposite scenario can also accomplish the similar objective. In this alternative embodiment, the device can have a first configuration that is unstressed and elongated and assumes a second, larger configuration (bulb) under stress. In this embodiment, a portion of the stylet or rod that is used to mechanically activate the device would be left behind to hold the expansion element in its stressed configuration.
  • Multiple components could include a frame to help with expansion of the device and a covering to obtain biocompatibility and tissue ingrowth. Examples of different frame configurations might include an expandable “Butterfly” or “Figure-8” configuration that could be constructed of wire material, such as Nitinol or multiple wires. Exemplary embodiments showing frame members 502 are depicted in FIG. 41A-E. Of course, other configurations such as diamonds or other rounded or polygonal shapes can be used. The diamond frame is a construct that takes a first form that is smaller and expands to a larger frame. The diamond elements could be constructed from a single wire or from multiple wires. Alternatively, the members could be constructed of elements that are moveable fixed at each of the ends to allow expansion. A tether or attachment device 504 is also depicted, which may be a suture, a wire, a screw, or other attachment means known in the art.
  • The frame could be cut from a single material, such as flat stock Nitinol to accomplish the same objective, as shown for example in FIG. 31. Such shapes can be cut from flat stock using known methods, for example, laser cutting. A heat forming step could also be employed, as known in the art, to form barbs 132 in a shape that passes out of the flat plane of the stock material, as shown in FIG. 27 for example.
  • Another frame configuration, also not shown, is that of a spiral or coil. The “Coil” design can be, for example, a spring steel or other biocompatible material that is wrapped to a first “wound” smaller configuration and expands to a larger unwrapped, unwound configuration.
  • Depending on the size of the openings in the frames described above, each of these concepts may or may not have a covering over them in order to assure that the nucleus does not re-extrude from the intervertebral disc space after placement of the device, as well as to serve as substrate for the surrounding tissue to naturally incorporate the device. Coverings might include ePTFE, polyester, silicone, or other biocompatible materials. Coverings could also include natural materials such as collagen, cellulose, autograft, xenograft, allograft or similar materials. The covering could also be biodegradable in nature, such as polyvinyl lactic acid.
  • Frames that are not covered may be permeable, such as a patch that is porous and allow for normal movement of fluids and nutrients through the patch into and out of the annular ring while maintaining nucleus fragments larger than the porosity of the stent/patch within the subannular space. Depending on the material that the frame is constructed, a surface finish may be added to promote tissue ingrowth into the patch. For example, a titanium sputtering of the device may allow it to be more easily incorporated within the disc space. Alternatively, a NiTi or tantalum foam could be added to the outer surface of the patch to promote tissue ingrowth.
  • It is understood that there can be a variety of device designs of patches to accomplish the expansion of a device from a first configuration, to a second configuration to occupy the sub-annular space and reduce re-extrusion of the nucleus. The following device concepts are further discussed for additional embodiments of a device and/or system for the repair of an intervertebral disc annulus.
  • As mentioned hereinabove, the stent/patch according to the present invention may comprise a mass of fascial autograft, and that autograft may be contained in a covering of material to form what will be referred to herein as a “bag”. Of course, this term is used not necessarily to connote a five-sided closed container so much as to denote the notion of flexibly surrounding the volume of a patch/stent material so that it can be manipulated in space.
  • In the most simplistic form, a prefabricated device of sutures could be used to form the “sling” to hold the fascial implant as discussed above. The advantage of this design over simple placement of sutures to hold the autograft is better containment and control of the autograft during and after implantation. The “sling” or a “bag” surrounds the fascial autograft to hold it in place. It is contemplated that other materials, such as a polyester mesh, could be used instead of the fascial autograft.
  • FIG. 38 shows an example of a pre-fabricated sling 300. There are three sutures used in this example, 302, 304, and 306, although there could be more or less sutures as would be understood by one of ordinary skill in the art. A collar member 308 has apertures or other features for attaching to the sutures. In this example, the third suture 306 passes along or within the collar 308 to form a loop extending from the lateral extent of the collar 308. The first and second sutures 302, 304 form loops from the superior and inferior extents of the collar 308. Intersections 310 can secure the loops to each other with small loops or knots in the sutures, small fabric attachment pieces, or by small preformed devices resembling grommets placed on the suture to aid in securement. Other knot tying techniques known in the art can also be employed. Turning to FIG. 39, the collar is depicted within the subannular space where the loops surround a fascial autograft 314 which by pulling proximally the sutures 302, 304, 306 the graft is collapsed into contact with the annular wall in a sealing manner. The sutures can be made of known materials, e.g., biodegradable, bioabsorbable or bioresorbable Vicryl or biocompatible nylon. The collar can be made of a fabric material, e.g., polyester. During placement, one end of some or each suture can be passed through the inferior wall of the annulus and the other end can be passed through the superior wall surrounding the aperture. After the placement of the sling into the wall of the annulus, the fascial autograft is placed within the sling. The sutures are tightened to bring the tissues together and also to help reapproximate the aperture, as the collar size will be selected based on the surgeon's judgment according to the degree of reapproximation desired.
  • Other constructions can also be used to accomplish the same objective, such as a “bag” 404 formed of expandable PTFE as shown in FIG. 40. The bag is placed through an aperture in the annulus 402. Additionally, a one way seal 406 can be positioned behind the aperture 408. Suturing techniques for introducing cardiac valves could be employed to place the seal. It is understood that there could be multiple constructs to accomplish the same objective and this is only given as an example.
  • The are a variety of ways to affix the device to the sub-annular wall of the annulus in addition to those discussed hereinabove. The following exemplary embodiments are introduced here to provide inventive illustrations of the types of techniques that can be employed to reduce the time and skill required to affix the patch to the annulus, versus suturing and tying a knot. Discussed hereinabove is the use of sutures, staples and other fixation devices, such as those passed through slot 18 to affix the patch to the annulus as shown in FIG. 1. FIG. 20 also depicts the use of “barbs” on the surface of the stent to facilitate fixation to the annulus. In a simple example, as shown in FIG. 20, a patch/stent could be compressed, passed through a guide tube such as tubes 18, 18A shown in FIGS. 22 and 23, and expanded within the sub-annular space. As shown in FIG. 42, the expanded patch 602 is shown having barbs 604, along with detachable delivery tool 608 and guide tube 606. Once expanded, barbs 604 on the outer surface of patch 602 can be used to fix the patch into the inner wall 610 of the annulus 612 by pulling the patch back proximally, into the sub-annular wall 610, and pushing forward distally on the guide tube 606, thus driving the barbs 604 into the annulus and drawing the inner and outer tissues of the annulus together and reapproximating the disc on either side of the aperture, as shown in FIG. 43. After the placement of the patch, the delivery tool and guide tube are removed.
  • The advantage of this design described above is that it requires very little time and skill to place and secure the patch to the annulus while also drawing the tissues together.
  • Materials of the patch could be similar to materials discussed hereinabove. Anchoring barbs could be made of a biocompatible material, for example a metallic material (e.g., NiTi alloy, Stainless steel, Titanium), or a polymeric material (e.g., polypropylene, polyethylene, polyurethane). Anchoring barbs could also be a biodegradable/bioabsorbable material, such as a polyglycolic acid (PGA), a polylevolactic acid (PPLA), a polydioxanone (PDA) or for example a racemic polylactic acid (PDLLA). If the barbs included a biodegradable/bioabsorbable material, it is anticipated that the barbs might have sufficient holding strength for a sufficient period of time to allow the patch to be incorporated into the annulus during the healing process. The advantage of having the anchoring barb of FIGS. 42 and 43 being biodegradable/bioabsorbable is that after the incorporation of the patch into the annulus there may be no need for the barbs to provide fixation. However, barbs pointing toward the outer surface of the annulus could pose a long term risk of penetration out of the annulus due to migration, and potentially impinging on the nerve root and spinal canal. Biodegradable/bioabsorbable barbs address and advantageously reduce any long-term risk in this regard.
  • It is also possible that the barbs could be made of both a biocompatible component and a biodegradable/bioabsorbable component. For example, the very tip of the barb could be made of a biodegradable material. The barb could penetrate the annulus wall with a rather sharp point, but after degradation the point of the barb would become dull. In this embodiment, the point would no longer induce continued scar formation after the patch has been incorporated, nor pose a risk of penetrating out of the annulus onto the nerve root.
  • Another fixation means includes the passing of “anchoring bands” into the wall of the annulus, vertebral bodies (superior, inferior, or both), or the Sharpey's Fibers (collagenous fibers between the junction of the annular fibers and vertebral bodies). In the following example of anchors, the barbs or bands are affixed to the annulus/vertebral bodies/Sharpey's fibers. Another element, for example a suture, cinch line, or a staple is utilized to attach the anchor bands to the patch, and thus hold the patch in proximity to the inner wall of the annulus. In addition, these bands may re-approximate the tissues at the aperture.
  • Revisiting one example of using barbs to anchor the device is shown in FIG. 9, described hereinabove. Barbs or bone anchor screws 50 ands 52 are passed into the superior and inferior vertebral bodies 54 and 56, respectively. Superiorly, suture 40 is passed through the outer wall of the annulus, to the sub-annular space. The suture is then passed through the eyelet 53 of bone anchor 52 and then passed through the wall of the annulus from the sub-annular space to the outer wall of the annulus. The inferior end of the suture is similarly passed through the annulus, eyelet of the bone anchor, and back through the wall of the annulus. Both ends of suture 40 are tightened and tied. The advantage of this concept is that it allows for fixation of the device to a surface that is known to be present in all discectomy procedures—the vertebral bodies. Whereas, it is possible, depending on the location and size of a natural rent that there may not be sufficient annulus accessible to fixate the device directly to the annulus. In addition to providing a location for fixation, anchoring into the vertebral bodies may provide a more stable anchor surface.
  • Another example of fixating the device to inner wall of the annulus is shown in FIG. 29, and is further illustrated by FIGS. 44-47. As discussed hereinabove, with reference to FIGS. 22-30, a patch 120 is placed with a delivery tool 122, through the inner lumen of a guide tube 118, into the sub-annular space and then expanded. This step can also be seen in FIGS. 45 and 46, where a patch 702 is folded and passed through a guide tube 706 and is held by a delivery tool 704. Also shown is a anchor band or staple 709 and an anchor band delivery device 708. Within the guide tube, or within the delivery tool, there is a suture line or cinch line 710 that is attached to the center of the patch 702. This can be seen in FIG. 44 a with the guide tube 706 removed. As seen in FIGS. 45C and 46A, the guide tube 706 is retracted after the patch 702 has been expanded and deployed. Next, an anchor band delivery tool 708 is used to deliver one or more “bands” 709 onto the outer surface of the annulus. These are intended to be anchored into the wall of the annulus with barb shapes that do not allow for the barbs to be pulled back through the annulus. The anchor bands resemble a construction of a “staple”. The bands could actually be constructed by connecting two barbed elements with, for example, a suture between the two barbed elements. The barbs and the connection band between the barbs could be constructed of the same material or of different materials. For example, the barbed part of the anchor band could be a biodegradable/bioabsorbable material (such as polyglycolic acid) or could be constructed of a metallic or polymeric biocompatible material (e.g., titanium, NiTi alloy, stainless steel, polyurethane, polypropylene). In addition, the band that connects these barbs can be constructed of materials that are similar to the barbs, or different materials. For example, the connection band could be a biodegradable/bioabsorbable suture, such as Vicryl, or a biocompatible material such as polypropylene. In addition, it is possible that these elements are constructed from multiple materials to accomplish the objective of anchoring into the annulus and providing for a fixation site to draw the patch within proximity of the sub-annular wall.
  • FIGS. 44B and 44C show the placement of the anchor bands 709 into the annulus 712 with the anchor band delivery tool 708. FIGS. 46A and 46B schematically show the placement of the anchor bands 709 into the wall of the annulus 712 and the retraction of the anchor band delivery device 708, with the patch delivery tool 704 still in place. FIG. 44D depicts a representative anchor band 709, having a pair of stainless steel barbs 709″ connected by a suture 709′. FIG. 44E shows the patch 702, anchor bands 709, and cinch line or suture 710 with the delivery tools removed, prior to drawing the patch and the tissues of the annulus together. In this embodiment there is a pre-fabricated knot 714 on the cinch line, which is described further in FIG. 47B, although other knots are possible. FIG. 47 a also shows a posterior view of the patching of the annulus with this device with knot 714. In this stent/patch 702 a pair of loops of 7 mm suture 709 are shown, which engage the cinch line and slip knot. These suture loops connect to the barbs directly, as in FIG. 44, or loop to surgical staples, or are placed directly into the annulus. The presence of a pre-fabricated knot on the cinch line makes the process of repairing quicker since there is no need to tie a knot. It also facilitates drawing the tissues together. The use of the cinch line and a pre-fabricated knot can be placed by, for example, an external tube such as a knot pusher. FIG. 44E is similar to the FIG. 29 described hereinabove prior to “tying” the knot 145. FIG. 44F shows the drawing of the patch and the annular tissues together by pulling on the suture in the direction “A” indicated by the arrow. In this case, the Knot Pusher has been removed from the cinch line 710. The suture 710 is drawn proximally to draw the patch 702 into engagement with the inner wall of the annulus to seal the aperture from within, as well as draw the walls of the annulus together to reapproximate the annular aperture. FIG. 46C and FIG. 44G show the cinch line suture 710 tied and drawing the annular tissues together, after the excess suture line has been cut. It is also apparent from this device, fixation and delivery system that the outer surfaces of the aperture are also drawn together for re-approximation.
  • The cinching of the bands and the patch also allows for taking-up the slack that allows for the accommodation of varying sizes. For example, the thickness of the annular wall surrounding the aperture can vary from 1 mm up to 10 mm. Therefore, if the anchor bands have a set length, this design with an cinch line accommodates different dimensions of the thickness of the wall of the annulus by drawing the “slack” of the bands together within the aperture.
  • Although it has been described here as patch placement that involves two lateral anchor bands with a suture to draw the patch, bands and tissues together, one or more bands could be used and two bands is only an example. Furthermore, the anchor bands were placed with the barbs in a superior-inferior fashion. One skilled in the art would recognize that these could be placed at different locations surrounding the aperture. Moreover, although it was described that the bands are placed into the annulus, these anchor bands could also be placed in the vertebral bodies as shown in FIG. 48A generally at 800, or the Sharpey's Fibers 802, as shown in FIG. 48B generally at 804.
  • Although the patch depicted in the example above does not have barbs attached to the patch, it is also possible to have the barbs as described hereinabove to further promote the fixation of the patch to the inner wall of the annulus.
  • Finally, although the drawings depict an aperture that lends itself to re-approximating the tissues, it is conceivable that some apertures, whether natural or surgically made, may be relatively large and therefore might require the placement of additional material within the aperture to act as a scaffold for tissue in growth, between the patch on the inner wall of the annulus and the anchor bands located on the outer wall. An example of material to fill the aperture might include autograft para-spinal fascial tissue, xenograft, allograft, or other natural collagenous materials. The filler material could also be of a biocompatible material such as a Dacron material. FIG. 51 shows the illustrative filling of an aperture with implant material 716 prior to cinching the suture 710.
  • As an alternative embodiment of the present invention, the anchor bands 709 as described previously (anchor bands into annulus) could be sufficiently long enough to pass through the annulus and then through the patch. The barbs in this embodiment have an engaging involvement with the patch. This concept was previously discussed hereinabove in connection with FIG. 30. Further illustration of such a system is schematically shown in FIGS. 49 and 50. Passing the barbs through the patch, in this embodiment, provides additional security and safety of reducing the possibility that the barbs may migrate after implantation. In this application of the invention, the suture cinch line may (FIG. 50) or may not (FIG. 30) be used in addition to the anchor bands to draw the tissues together and reduce tissue movement surrounding the aperture.
  • In addition, although the bands shown in FIGS. 49 and 50 take the form of a “barb”, they could as easily take a form of a simple T-barb 720, as shown in FIG. 52E, or a C-type element wherein the object is to have irrevocable engagement with the patch device 702 after the penetration through the patch. A T-type attachment, when aligned longitudinally with the suture, passes through the patch. The T section then rotates to prevent the suture anchor from being pulled back through the patch. In another embodiment a “C’ retainer made of a superelastic material may be attached to the end of the suture band. The C retainer is loaded into a needle wherein it is held straight. The needle is used to pass the C retainer and suture through the patch and deploy the retainer in a second configuration in the shape of a “C”.
  • It is also foreseen within the scope of the invention that there may be patch designs which will accommodate the placement and securement of the anchor to the fabric that covers the frame of the patch. For example, a frame for a patch that is made out of metal such as Nitinol can provide for “windows”. The device, covered with a mesh fabric, for example silicone or Dacron, would therefore allow the anchoring barbs to be passed through the “windows” in the frame of the patch. In this case, the barb can be secured to the patch in the fabric covering the frame.
  • Alternatively, the patch can be secured by passing barbs that engage the lattice of the patch frame. These embodiments of the invention illustrate designs in which the barbs engage with the vertical, horizontal or criss-crossed structures/members of the frame. In this case, the barbs would pass through the mesh or lattice of the frame and they would be unable to pass back out of the structure.
  • Although this discussion refers to “anchor bands” that are shown to be two anchors connected by a suture, it is also contemplated that single barbs with sutures are placed and the sutures' ends, at the outer surface of the annulus, are tied after placement through the patch.
  • One objective in the designs discussed hereinabove is to provide a way to “pull up the slack” in a system to adjust the length of sutures and for anchor bands. According to the present invention, a technique referred to as the “Lasso Cinch Knot” was developed as a means to draw the anchor bands together with a suture cinch line that is incorporated into the patch design. FIG. 53 gives further description of the use of the Lasso embodiment. In essence, patch and frame constructs are used that incorporate the “barbs through the patch” design. Once the barbs have passed through the patch, an internal lasso 722 is drawn tight around the sutures of the anchor bands and thus draws the extra suture material within the patch. The internal lasso gathers the sutures of the bands, and as the lasso is tightened, it cinches together the sutures of the bands and therefore tightens them and eliminates slack, bringing the patch/stent into closer or tighter engagement with the annulus wall. The patch in FIG. 53 additionally provides for a diamond shape grid pattern, which advantageously provides a grid which will while allowing a probe or similar instrument to pass through with little resistance, provides resistance to a barb or other restraining feature on the instrument. The frame shown can be made from nitinol, and the locking and holding windows shown at the center of the figure would allow for rotation about the z-axis during placement. A slipknot technique using, for example a knot pusher, would aid in the loop pulling process by the lasso. The internal loop (lasso) can be tacked to the outside corners of the patch/stent, in order to hold the loop at the outer edges of the patch frame. When cinching the lasso knot, the loop can be pulled free from some or all of its tacked attachment points to the frame, to prevent deformation of the planar shape of the frame when cinching the lasso. As above, the frame can be a composite structure or sandwich formed with some type of mesh fabric. The proximal mesh fabric can be bonded fully to the patch frame, for example through the use of an adhesive, for instance a silicone. Adhesive, advantageously, can fill the interstices of the grid pattern while allowing for easy probe penetration and protection of the suture lines. Protection of the suture lines is advantageous when the lasso is used to pull and bunch a group of band sutures together.
  • It is also contemplated within the scope of the present invention that sutures 710′ can be preattached directly to a stent/patch. As shown in FIG. 52A several separate barbs 709′″ into the annulus 712 can be directly attached to the patch 702. Each “barb” of FIG. 52A can be independently placed into the annulus after the patch is deployed. This can be seen to be similar to the embodiment including barbs 709″″ of FIG. 55.
  • An alternative embodiment for securing a patch 902 and reapproximating a rent is providing each of the separate barbs with sutures having variable lengths as shown in FIG. 56. Each independent suture barb 904 is placed into the annulus 906 or into the patch 902 with the barb delivery tool 908. After the placement, all of the suture lines 910 are drawn taught, by drawing on the free ends that exit the patch delivery tool 912. A locking element 914 that uses a gasket 916 and threading mechanism is attached to the patch 902 and is used to tighten the gasket 916 around the distal ends of the sutures 910. The patch delivery tool 912 is removed and the extra suture length is cut. It is also possible that the gasket mechanism could be a press-fit to accommodate the tightening of the sutures to the patch.
  • Alternatively, the locking mechanism can be as shown in FIG. 57, although in this case the engagement of the locking element 914′ takes part on the patch. Pulling the suture 910 in the direction of arrow B will tighten and lockingly hold in tension to aid in securement and reapproximation. The adjustable length suture band between the two anchors allows slack to be taken up between the anchors 916. Two T-type anchors are illustratively shown in this example, but multiple anchors of differing configurations could be used. The locking features can be included on the feature band, as depicted here, and allow for substantially one-way locking engagement with the anchor members. This adjustability advantageously promotes for the accommodation of varying thickness of the annulus from patient to patient. The suture slack in this embodiment may be taken up to close the defect in the annulus and/or to shorten the band between anchors for a secondary cinching of multiple tensioned suture bands as described hereinabove.
  • The cinch line and the Lasso concepts in essence try to facilitate the re-approximation and drawing of tissues together in a fast and simple way. Other contemplated embodiments for “tension” elements include using an elastic coupler as a part of the anchor band used to fixate the device. The elastic coupler can be expanded for placement, and upon release, can draw tension to pull the tissues together. The coupler could be made of a biocompatible metal or polymer, or could be constructed of a biodegradable/bioabsorbable material.
  • Similarly, an alternative embodiment to cause tension within the device and draw the tissues together after placement of the anchor bands might include an elastic band or band with a spring which one end can be attached to the anchor bands and the other end attached to the patch. Alternatively, the anchor bands might, in and of themselves may be made of an elastic band between the barbs, or may contain a spring element between the barbs. Such an embodiment can be made to resemble a so-called “Bobber Spring.” Again, it is contemplated that the elastic or resilient element could be made from a wide variety of metals, polymeric, or biodegradable/bioabsorbable material.
  • FIG. 59 describes an embodiment where the patch element 1002 takes the form of a mesh seal. The securement is effected by a hook having a barb element 1004 that penetrates the inner surface of the annulus 1006, while the inner connection of the hook (barb) 1004 is attached to the patch in such a fashion as to add tension between the outer surface of the annulus and the inner surface in proximity to the patch, thus drawing the annular tissues together. The patch/stent 1002 contains a spring ribbon element 1008 which can be formed from nitinol or other spring material. Hooks 1010 are then deployed to “grab” the annulus, either through penetration or through grasping into the aperture 1012 as shown.
  • FIGS. 54 a-f shows another embodiment of a means to draw the suture lines together to cause tension between the inner and outer tissues of the annulus. Anchor bands, for example T-barbs 720′ are placed through the annulus and the patch, and they are secured to the patch 702. “Slack” in the suture of the anchor band is “rotated” around a detachable portion of the delivery tool 704′ and a locking element, for example a screw configuration 724 as shown in the drawing, is used to lock the extra suture line in place affixed to threads 726 with the patch 702. The delivery tool 704′ is then removed.
  • FIG. 58 shows alternative embodiments for tightening “anchoring barbs” with different configurations of sutures and cinch lines. For example in FIG. 58B each independent barb has a looped suture attached to it. Through each of these loops is passed a cinch line, which contains a knot. After placement of the barbs within the annulus, and possibly through the patch, the cinch line draws the loops of the barbs together. The advantage of this embodiment is that it allows for the independent placement of multiple barbs and the ability to draw all of them together.
  • Although cinch lines have been described as using a knot to “lock” the length of the suture, other mechanisms could also lock the length, as shown in FIG. 57. The locking of the suture length is accomplished through a mechanical element located on the barb which engages with three dimensional elements attached to the suture line which mechanically press fit through the engagement element on the barb, thus locking the length of the suture line into place.
  • Although the embodiments of FIG. 57 and FIG. 58 depict the use of a single locking mechanism (e.g., knot on cinch line), it is conceivable that various designs could use more than one locking element to achieve the re-approximation and drawing together the tissue surrounding an aperture.
  • A further exemplary embodiment of the invention further describes a concept illustrated by FIG. 41 e, for example. A braided patch 1100 such as depicted in FIGS. 60 through 66, is a further illustrative embodiment of the present invention that can be deployed into the subannular space to act as a barrier to the extrusion of the nucleus pulposus.
  • The “patch” 1100 is constructed from a braided tube of filaments 1102. The ends 1104 of the braided tube are heat-sealed to keep the braid from unraveling and the seals also provide structural integrity to the patch when deployed. The braided patch 1100 is woven on a braiding machine with multiple filaments 1102 to create the structure. For example, the patch can be woven with 72 polyester filaments in order to create the construct that readily deploys into the annular defect, promotes cell ingrowth into the device, and retains an anchor after it has been placed through the wall of the annulus and through the patch. Changing the number of filaments 1102 in the patch, the material of the filaments, the dimension of the filaments (e.g., diameter), as well as the configuration of the filaments (e.g., cross-sectional area), or changing the braid pattern, can create differences in the characteristics of the patch. The braided patch can be made on a standard Steeger braider, or similar type braiding machine, that can handle braiding from anywhere from 16 filaments at a time, to up to 196 filaments. Preferably the patch is braided with between 32 to 144 filaments.
  • The filaments 1102 of the patch can be made of different materials or all of the filaments in a patch can be of like material and dimensions. The filaments can be metallic, such as a stainless steel, a nickel titanium alloy, or other metallic materials. The patch 1100 can also be made from biocompatible polymeric material such as polyethyleneteraphthalate, polyester, polyethylene, or polypropylene, for example. It is also conceivable that the patch can be braided from biodegradable materials, such as polyglycolic acid (PGA), polylactic acid (PLA), or other material that may degrade and be re-absorbed by the body over time.
  • It is also possible to braid the patch 1100 with multiple materials and/or multiple dimensions of the filaments. For example, the patch can be braided with 32 filaments of a polymeric PET material and 32 filaments of polyester yarn material to create a patch that is optimal for sealing an annulus. The combination of different filament materials, sizes, cross-sectional configuration, number of filaments, and braiding pattern can be used to construct a braided patch that can be delivered into the sub-annular space, while acting as a scaffold to induce healing of the aperture.
  • The braided patch has advantages in that it can be placed through an aperture in the wall of the annulus that is relatively small, but then expand to a dimension that is substantially greater than the aperture. For example, it is possible to construct the braided tube to be less than 5 mm in diameter, whereas in its fully deployed state it could be greater than, for example, 20 mm.
  • Referring to FIG. 62, the non-deployed braided patch 1100 is affixed on the distal end of the patch delivery tool 1200. It is situated in a fashion that is co-axial with the delivery tool's delivery members. Further detail of the deployment mechanism can be seen in FIG. 63. The braided patch 1100 is placed on the distal end of the inner delivery member 1202. The heat-set distal cuff 1104 of the patch is situated within a depressed region on the distal region of the inner delivery member 1216. The distal portion of the delivery member 1216 is slotted as shown in FIG. 65, and, in the non-deployed state, contains a co-axial retention member 1208 that acts to press the slotted potions of the inner delivery member apart, and thus securing the distal cuff of the patch 1104 on the distal region of the inner delivery member 1202. The proximal portion of the patch abuts and is in contact with an outer pusher member 1204. In the non-deployed state, the delivery device is passed into the aperture of the annulus. Once inside the annular aperture, the outer pusher member 1204 of the delivery device 1200 is pushed toward the distal end of the device, while the inner delivery member 1202 is pulled proximally. This action of moving these members in such a fashion results in the braided patch expanding perpendicular to tube's axis, as shown in FIGS. 61 and 64.
  • Once the patch 1100 has been expanded to its fully expanded state, a cinch line 1212 that is connected to the distal and proximal ends of the patch can be tightened and a knot, such as a Roeder knot, can be used to hold the braided patch in its expanded configuration. Although, the device is shown with a cinch knot 1214, it is possible that a locking element may not be needed, depending on the means used to fixate the patch into the annulus. It is possible that no locking means is necessary. It is also possible that alternative locking means can be contemplated to keep the braided patch in its expanded form. A knot pusher 1210 can also be employed to manipulate the knot locking device 1214.
  • Once the device patch has been expanded into its final configuration in the aperture and subannular space, the retention member can be removed from the distal portion of the inner member by slidably pulling the proximal end of the retention member in a proximal direction. Removing the retention member relieves the stress holding the distal cuff of the patch in place and allows the patch to be slideably removed from the distal end of the delivery device, and thus deployed into the subannular space.
  • As depicted in FIG. 66, the patch 1100 can be affixed to the inner surface either before or after the deployment of the patch from the delivery device. It is also contemplated that this patch can be affixed to the inner surface of the annulus by the various fixation means described in other parts of this application. For example, anchor bands as shown in FIG. 29 could be used to penetrate the annulus and the patch to anchor the patch into the sub-annular space. It is also conceivable that single T-anchors 1310 with a band 1314 (e.g., suture) could be delivered through the annulus 1306 and patch 1100 with the portion of the suture on the outer surface of the annulus locked to the outer surface with a knot, pledget, or other locking device 1316. It is also conceivable that the patch could be affixed to the inner surface of the annulus through the use of adhesives, such as cyanoacrylate, fibrin glue, polymer protein, polyurethane or other material used to cure the patch in the subannular space in situ. Path 1312 illustrated another possible suture path through the bone of the vertebra to penetrate and hold a T-anchor member 1310 in the patch.
  • A device suitable for affixing a stent or patch to a disc annulus is disclosed in copending U.S. patent application Ser. No. 10/327,106, filed on Dec. 24, 2002, and commonly assigned herein, the contents of which are incorporated herein by reference.
  • The advantages of this design, given the right selection of filament dimension, configuration, material, braid pattern, and number of filaments is that it can be easily delivered to the annular repair site, have the flexibility to take the shape of the annular defect while maintaining the mechanical integrity needed to remain within the disc space upon loading. Another advantage, again with the appropriate selection of material, filament configuration, braiding, dimensional considerations, and multiple filament weaves, is that one can construct a patch that is conducive, in its deployed state, for incorporation of fibrosis and the fibrotic healing of the annular defect. Finally, the patch can be designed so that when it is in its delivered state, it can easily receive one or more anchor bands through the braided filaments while retaining the T-anchor or other similar type fixation device, after passing the fixation device through the patch.
  • All patents referred to or cited herein are incorporated by reference in their entirety to the extent they are not inconsistent with the explicit teachings of this specification, including; U.S. Pat. No. 5,108,438 (Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Ray et al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331 (Ducheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No. 5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.) and U.S. Pat. No. 5,376,120 (Sarver et al.).
  • Various materials know to those skilled in the art can be employed in practicing the present invention. By means of example only, the body portions of the stent could be made of NiTi alloy, plastics including polypropylene and polyethylene, stainless steel and other biocompatible metals, chromium cobalt alloy, or collagen. Webbing materials can include silicone, collagen, ePTFE, DACRON, polyester, polypropylene, polyethylene, and other biocompatible materials and can be woven or non-woven. Membranes might be fashioned of silicone, propylene, polyester, SURLYN, PEBAX, polyethylene, polyurethane or other biocompatible materials. Inflation fluids for membranes can include gases, liquids, foams, emulsions, and can be or contain bioactive materials and can also be for mechanical, biochemical and medicinal purposes. The stent body, webbing and/or membrane can be drug eluting or bioabsorbable, as known in the medical implant arts.
  • Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (8)

1. A device for treating an aperture in the annulus of a patient's intervertebral disc, said device comprising a cylindrical body formed of a plurality of filamentous elements, said body having a radial diameter, a first end and a second end subtending a longitudinal dimension, said device having a first configuration, and a second configuration, wherein the second configuration, in use, is characterized by a relatively larger radial diameter along at least a portion of said longitudinal dimension.
2. The device of claim 1, wherein said body is sized to be inserted through said aperture in a intervertebral disc into the subannular space in said first configuration and then placed in said second configuration to at least partially cover said aperture.
3. The device of claim 1, wherein said second configuration is additionally characterized by a relatively smaller longitudinal dimension in said second configuration than in said first configuration.
4. The device of claim 1, wherein at least a portion of the stent is formed at least in part of flexible biocompatible material.
5. The device of claim 1, wherein at least a portion of the stent is formed at least in part of bioresorbable material.
6. The device of claim 1, wherein at least a portion of the stent is formed at least in part of nylon.
7. The device of claim 1, wherein at least a portion of the stent is formed at least in part by weaving.
8. The device of claim 1, wherein at least a portion of the stent is formed at least in part by braiding.
US11/386,616 1999-10-20 2006-03-23 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent Abandoned US20060173545A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/386,616 US20060173545A1 (en) 1999-10-20 2006-03-23 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US16071099P 1999-10-20 1999-10-20
US48470600A 2000-01-18 2000-01-18
US09/947,078 US6592625B2 (en) 1999-10-20 2001-09-05 Spinal disc annulus reconstruction method and spinal disc annulus stent
US10/075,615 US20020123807A1 (en) 1999-10-20 2002-02-15 Spinal disc annulus reconstruction method and spinal disc annulus stent
US10/133,339 US7052516B2 (en) 1999-10-20 2002-04-29 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US10/352,981 US20030153976A1 (en) 1999-10-20 2003-01-29 Spinal disc annulus reconstruction method and spinal disc annulus stent
US11/386,616 US20060173545A1 (en) 1999-10-20 2006-03-23 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US10/352,981 Continuation US20030153976A1 (en) 1999-10-20 2003-01-29 Spinal disc annulus reconstruction method and spinal disc annulus stent

Publications (1)

Publication Number Publication Date
US20060173545A1 true US20060173545A1 (en) 2006-08-03

Family

ID=32849510

Family Applications (3)

Application Number Title Priority Date Filing Date
US10/352,981 Abandoned US20030153976A1 (en) 1999-10-20 2003-01-29 Spinal disc annulus reconstruction method and spinal disc annulus stent
US11/386,616 Abandoned US20060173545A1 (en) 1999-10-20 2006-03-23 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US11/512,251 Expired - Fee Related US7846208B2 (en) 1999-10-20 2006-08-30 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US10/352,981 Abandoned US20030153976A1 (en) 1999-10-20 2003-01-29 Spinal disc annulus reconstruction method and spinal disc annulus stent

Family Applications After (1)

Application Number Title Priority Date Filing Date
US11/512,251 Expired - Fee Related US7846208B2 (en) 1999-10-20 2006-08-30 Spinal disc annulus reconstruction method and deformable spinal disc annulus stent

Country Status (7)

Country Link
US (3) US20030153976A1 (en)
EP (1) EP1594422A4 (en)
JP (1) JP2007501101A (en)
AU (1) AU2004210109B2 (en)
CA (1) CA2512142A1 (en)
IL (1) IL169904A0 (en)
WO (1) WO2004069026A2 (en)

Cited By (56)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060129242A1 (en) * 2001-12-28 2006-06-15 Brian Bergeron Pseudo arthrosis device
US20060287731A1 (en) * 1999-10-20 2006-12-21 Cauthen Joseph C Iii Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US20070061012A1 (en) * 1999-10-20 2007-03-15 Cauthen Joseph C Iii Intervertebral disc annulus stent
US20070244562A1 (en) * 2005-08-26 2007-10-18 Magellan Spine Technologies, Inc. Spinal implants and methods of providing dynamic stability to the spine
US20080009944A1 (en) * 2001-10-02 2008-01-10 Rex Medical Spinal implant and method of use
US20080071377A1 (en) * 2005-08-26 2008-03-20 Magellan Spine Technologies, Inc. Spinal implants and methods of providing dynamic stability to the spine
US20080133012A1 (en) * 2006-11-16 2008-06-05 Mcguckin James F Spinal implant and method of use
US20080154376A1 (en) * 2006-12-20 2008-06-26 Bergeron Brian J Surgical implant suitable for replacement of an intervertebral disc
FR2914178A1 (en) * 2007-03-27 2008-10-03 Cie De Rech En Composants Impl Reinforcement implantable prosthesis i.e. parietal prosthesis, for e.g. anesthesia patient, has fixation unit passed via attachment orifice and supported against biological tissue at periphery of orifice to form anti-return unit
US20090138084A1 (en) * 2007-11-19 2009-05-28 Magellan Spine Technologies, Inc. Spinal implants and methods
US7666226B2 (en) 2005-08-16 2010-02-23 Benvenue Medical, Inc. Spinal tissue distraction devices
US7749273B2 (en) 1999-10-20 2010-07-06 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US7828850B2 (en) 1999-10-20 2010-11-09 Anulex Technologies, Inc. Methods and devices for spinal disc annulus reconstruction and repair
US20100286779A1 (en) * 2009-05-06 2010-11-11 Thibodeau Lee L Expandable spinal implant apparatus and method of use
US7922768B2 (en) 1999-10-20 2011-04-12 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US7935147B2 (en) 1999-10-20 2011-05-03 Anulex Technologies, Inc. Method and apparatus for enhanced delivery of treatment device to the intervertebral disc annulus
US7951201B2 (en) 1999-10-20 2011-05-31 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US20110153017A1 (en) * 2009-12-22 2011-06-23 Mcclellan William T Systems and methods for tissue expansion with fluid delivery and drainage system
US7988735B2 (en) * 2005-06-15 2011-08-02 Matthew Yurek Mechanical apparatus and method for delivering materials into the inter-vertebral body space for nucleus replacement
US8012211B2 (en) * 2002-11-05 2011-09-06 Spineology, Inc. Semi-biological intervertebral disc replacement system
US8128698B2 (en) 1999-10-20 2012-03-06 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US8163022B2 (en) 2008-10-14 2012-04-24 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US8366773B2 (en) 2005-08-16 2013-02-05 Benvenue Medical, Inc. Apparatus and method for treating bone
US8454617B2 (en) 2005-08-16 2013-06-04 Benvenue Medical, Inc. Devices for treating the spine
US8460319B2 (en) 2010-01-11 2013-06-11 Anulex Technologies, Inc. Intervertebral disc annulus repair system and method
US8535327B2 (en) 2009-03-17 2013-09-17 Benvenue Medical, Inc. Delivery apparatus for use with implantable medical devices
US8556977B2 (en) 1999-10-20 2013-10-15 Anulex Technologies, Inc. Tissue anchoring system and method
US8591583B2 (en) 2005-08-16 2013-11-26 Benvenue Medical, Inc. Devices for treating the spine
US8814873B2 (en) 2011-06-24 2014-08-26 Benvenue Medical, Inc. Devices and methods for treating bone tissue
US9078761B2 (en) 2009-11-12 2015-07-14 Anchor Orthopedics Xt Inc. Devices and methods for treating tissue defects
US9737294B2 (en) 2013-01-28 2017-08-22 Cartiva, Inc. Method and system for orthopedic repair
US9788963B2 (en) 2003-02-14 2017-10-17 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10085783B2 (en) 2013-03-14 2018-10-02 Izi Medical Products, Llc Devices and methods for treating bone tissue
US10179012B2 (en) 2013-01-28 2019-01-15 Cartiva, Inc. Systems and methods for orthopedic repair
US10888433B2 (en) 2016-12-14 2021-01-12 DePuy Synthes Products, Inc. Intervertebral implant inserter and related methods
US10940016B2 (en) 2017-07-05 2021-03-09 Medos International Sarl Expandable intervertebral fusion cage
US10966840B2 (en) 2010-06-24 2021-04-06 DePuy Synthes Products, Inc. Enhanced cage insertion assembly
US10973652B2 (en) 2007-06-26 2021-04-13 DePuy Synthes Products, Inc. Highly lordosed fusion cage
US11273050B2 (en) 2006-12-07 2022-03-15 DePuy Synthes Products, Inc. Intervertebral implant
US11344424B2 (en) 2017-06-14 2022-05-31 Medos International Sarl Expandable intervertebral implant and related methods
US11426290B2 (en) 2015-03-06 2022-08-30 DePuy Synthes Products, Inc. Expandable intervertebral implant, system, kit and method
US11426286B2 (en) 2020-03-06 2022-08-30 Eit Emerging Implant Technologies Gmbh Expandable intervertebral implant
US11446156B2 (en) 2018-10-25 2022-09-20 Medos International Sarl Expandable intervertebral implant, inserter instrument, and related methods
US11446155B2 (en) 2017-05-08 2022-09-20 Medos International Sarl Expandable cage
US11452607B2 (en) 2010-10-11 2022-09-27 DePuy Synthes Products, Inc. Expandable interspinous process spacer implant
US11497619B2 (en) 2013-03-07 2022-11-15 DePuy Synthes Products, Inc. Intervertebral implant
US11510788B2 (en) 2016-06-28 2022-11-29 Eit Emerging Implant Technologies Gmbh Expandable, angularly adjustable intervertebral cages
US11596523B2 (en) 2016-06-28 2023-03-07 Eit Emerging Implant Technologies Gmbh Expandable and angularly adjustable articulating intervertebral cages
US11602438B2 (en) 2008-04-05 2023-03-14 DePuy Synthes Products, Inc. Expandable intervertebral implant
US11607321B2 (en) 2009-12-10 2023-03-21 DePuy Synthes Products, Inc. Bellows-like expandable interbody fusion cage
US11612491B2 (en) 2009-03-30 2023-03-28 DePuy Synthes Products, Inc. Zero profile spinal fusion cage
US11654033B2 (en) 2010-06-29 2023-05-23 DePuy Synthes Products, Inc. Distractible intervertebral implant
US11737881B2 (en) 2008-01-17 2023-08-29 DePuy Synthes Products, Inc. Expandable intervertebral implant and associated method of manufacturing the same
US11752009B2 (en) 2021-04-06 2023-09-12 Medos International Sarl Expandable intervertebral fusion cage
US11850160B2 (en) 2021-03-26 2023-12-26 Medos International Sarl Expandable lordotic intervertebral fusion cage
US11911287B2 (en) 2010-06-24 2024-02-27 DePuy Synthes Products, Inc. Lateral spondylolisthesis reduction cage

Families Citing this family (86)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6964674B1 (en) * 1999-09-20 2005-11-15 Nuvasive, Inc. Annulotomy closure device
US6805695B2 (en) 2000-04-04 2004-10-19 Spinalabs, Llc Devices and methods for annular repair of intervertebral discs
US7771478B2 (en) 2003-04-04 2010-08-10 Theken Spine, Llc Artificial disc prosthesis
BRPI0410324A (en) 2003-05-15 2006-05-23 Biomerix Corp implantable device, elastomeric matrix production lyophilization processes having a cross-linked structure, polymerization for cross-linked elastomeric matrix preparation and cross-linked composite elastomeric implant preparation, and method for treating an orthopedic disorder
US7763077B2 (en) * 2003-12-24 2010-07-27 Biomerix Corporation Repair of spinal annular defects and annulo-nucleoplasty regeneration
ATE410961T1 (en) 2004-08-16 2008-10-15 Zimmer Spine Inc SPIRAL SEWING DEVICE
WO2006034436A2 (en) 2004-09-21 2006-03-30 Stout Medical Group, L.P. Expandable support device and method of use
US8409282B2 (en) 2004-10-20 2013-04-02 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8613747B2 (en) 2004-10-20 2013-12-24 Vertiflex, Inc. Spacer insertion instrument
US8012207B2 (en) 2004-10-20 2011-09-06 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8152837B2 (en) * 2004-10-20 2012-04-10 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8277488B2 (en) 2004-10-20 2012-10-02 Vertiflex, Inc. Interspinous spacer
US8945183B2 (en) 2004-10-20 2015-02-03 Vertiflex, Inc. Interspinous process spacer instrument system with deployment indicator
US8128662B2 (en) 2004-10-20 2012-03-06 Vertiflex, Inc. Minimally invasive tooling for delivery of interspinous spacer
WO2009009049A2 (en) 2004-10-20 2009-01-15 Vertiflex, Inc. Interspinous spacer
US9023084B2 (en) 2004-10-20 2015-05-05 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for stabilizing the motion or adjusting the position of the spine
US8425559B2 (en) 2004-10-20 2013-04-23 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US9161783B2 (en) 2004-10-20 2015-10-20 Vertiflex, Inc. Interspinous spacer
US8167944B2 (en) 2004-10-20 2012-05-01 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8123807B2 (en) 2004-10-20 2012-02-28 Vertiflex, Inc. Systems and methods for posterior dynamic stabilization of the spine
US8317864B2 (en) 2004-10-20 2012-11-27 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8864828B2 (en) 2004-10-20 2014-10-21 Vertiflex, Inc. Interspinous spacer
US7763074B2 (en) 2004-10-20 2010-07-27 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for posterior dynamic stabilization of the spine
US8123782B2 (en) 2004-10-20 2012-02-28 Vertiflex, Inc. Interspinous spacer
US9119680B2 (en) 2004-10-20 2015-09-01 Vertiflex, Inc. Interspinous spacer
AU2008343092B2 (en) 2004-12-06 2014-09-11 Vertiflex, Inc. Spacer insertion instrument
US8702718B2 (en) 2005-04-29 2014-04-22 Jmea Corporation Implantation system for tissue repair
US7632313B2 (en) 2005-04-29 2009-12-15 Jmea Corporation Disc repair system
US20060247776A1 (en) 2005-05-02 2006-11-02 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for augmenting intervertebral discs
US7601172B2 (en) * 2005-06-15 2009-10-13 Ouroboros Medical, Inc. Mechanical apparatus and method for artificial disc replacement
US8021426B2 (en) * 2005-06-15 2011-09-20 Ouroboros Medical, Inc. Mechanical apparatus and method for artificial disc replacement
US7442210B2 (en) 2005-06-15 2008-10-28 Jerome Segal Mechanical apparatus and method for artificial disc replacement
US7547319B2 (en) 2005-06-15 2009-06-16 Ouroboros Medical Mechanical apparatus and method for artificial disc replacement
US20070162135A1 (en) * 2005-06-15 2007-07-12 Jerome Segal Mechanical apparatus and method for artificial disc replacement
WO2007009107A2 (en) 2005-07-14 2007-01-18 Stout Medical Group, P.L. Expandable support device and method of use
US20070233252A1 (en) * 2006-02-23 2007-10-04 Kim Daniel H Devices, systems and methods for treating intervertebral discs
US20070255406A1 (en) * 2006-04-27 2007-11-01 Sdgi Holdings, Inc. Devices, apparatus, and methods for bilateral approach to disc augmentation
US8133279B2 (en) 2006-04-27 2012-03-13 Warsaw Orthopedic, Inc. Methods for treating an annulus defect of an intervertebral disc
EP2023864B1 (en) 2006-05-01 2019-07-10 Stout Medical Group, L.P. Expandable support device
US20080065218A1 (en) * 2006-09-13 2008-03-13 O'neil Michael J Annulus fibrosus repair devices and techniques
US8900306B2 (en) 2006-09-26 2014-12-02 DePuy Synthes Products, LLC Nucleus anti-expulsion devices and methods
US20080082170A1 (en) * 2006-09-29 2008-04-03 Peterman Marc M Apparatus and methods for surgical repair
US20080172126A1 (en) * 2006-10-03 2008-07-17 Reynolds Martin A Nucleus pulposus injection devices and methods
US8845726B2 (en) 2006-10-18 2014-09-30 Vertiflex, Inc. Dilator
US8021429B2 (en) * 2007-03-08 2011-09-20 Zimmer Spine, Inc. Deployable segmented TLIF device
AU2008241447B2 (en) 2007-04-16 2014-03-27 Vertiflex, Inc. Interspinous spacer
US8864801B2 (en) 2007-04-30 2014-10-21 Warsaw Orthopedic, Inc. Method of deformity correction in a spine using injectable materials
US20090076029A1 (en) * 2007-06-01 2009-03-19 Palatin Technologies, Inc. Compounds and Methods for Treating Obesity
US20090062852A1 (en) * 2007-08-29 2009-03-05 Marino James F Annular repair device and methods
WO2009149455A1 (en) * 2008-06-06 2009-12-10 Synthes Usa, Llc Suture based tissue repair
US20100211176A1 (en) 2008-11-12 2010-08-19 Stout Medical Group, L.P. Fixation device and method
WO2010056895A1 (en) 2008-11-12 2010-05-20 Stout Medical Group, L.P. Fixation device and method
US10045860B2 (en) 2008-12-19 2018-08-14 Amicus Design Group, Llc Interbody vertebral prosthetic device with self-deploying screws
US8182533B2 (en) * 2009-01-19 2012-05-22 Richard Perkins Annular repair device and method
US20110282456A1 (en) * 2009-02-05 2011-11-17 Newvert Ltd. Implantable device for sealing a spinal annular fissure tear and method for deploying the same
NL2002742C2 (en) * 2009-04-09 2010-10-12 Univ Delft Tech Mechanical device for tissue regeneration.
US9044335B2 (en) 2009-05-05 2015-06-02 Cornell University Composite tissue-engineered intervertebral disc with self-assembled annular alignment
US8814903B2 (en) 2009-07-24 2014-08-26 Depuy Mitek, Llc Methods and devices for repairing meniscal tissue
US8828053B2 (en) 2009-07-24 2014-09-09 Depuy Mitek, Llc Methods and devices for repairing and anchoring damaged tissue
US8211126B2 (en) 2009-09-22 2012-07-03 Jmea Corporation Tissue repair system
US8740948B2 (en) 2009-12-15 2014-06-03 Vertiflex, Inc. Spinal spacer for cervical and other vertebra, and associated systems and methods
US9743919B2 (en) 2010-04-27 2017-08-29 DePuy Synthes Products, Inc. Stitch lock for attaching two or more structures
US9597064B2 (en) 2010-04-27 2017-03-21 DePuy Synthes Products, Inc. Methods for approximating a tissue defect using an anchor assembly
US9173645B2 (en) 2010-04-27 2015-11-03 DePuy Synthes Products, Inc. Anchor assembly including expandable anchor
US9451938B2 (en) 2010-04-27 2016-09-27 DePuy Synthes Products, Inc. Insertion instrument for anchor assembly
US8535380B2 (en) 2010-05-13 2013-09-17 Stout Medical Group, L.P. Fixation device and method
EP2608747A4 (en) 2010-08-24 2015-02-11 Flexmedex Llc Support device and method for use
US9149286B1 (en) 2010-11-12 2015-10-06 Flexmedex, LLC Guidance tool and method for use
CN103930058A (en) 2011-08-23 2014-07-16 弗雷科斯米德克斯有限公司 Tissue removal device and method
US9204959B2 (en) * 2012-02-02 2015-12-08 Smith & Nephew, Inc. Implantable biologic holder
US9566165B2 (en) 2012-03-19 2017-02-14 Amicus Design Group, Llc Interbody vertebral prosthetic and orthopedic fusion device with self-deploying anchors
EP2827807B1 (en) 2012-03-19 2019-12-11 Amicus Design Group, LLC Interbody vertebral prosthetic and orthopedic fusion device with self-deploying anchors
WO2013179277A1 (en) 2012-05-30 2013-12-05 Newvert Ltd. Spinal disc annulus closure device
US10786235B2 (en) 2012-10-31 2020-09-29 Anchor Innovation Medical, Inc. Method and apparatus for closing a fissure in the annulus of an intervertebral disc, and/or for effecting other anatomical repairs and/or fixations
US9034052B2 (en) * 2013-01-14 2015-05-19 Warsaw Orthopedic, Inc. Delivery systems containing bioactive materials
US20140277467A1 (en) 2013-03-14 2014-09-18 Spinal Stabilization Technologies, Llc Prosthetic Spinal Disk Nucleus
US9675303B2 (en) 2013-03-15 2017-06-13 Vertiflex, Inc. Visualization systems, instruments and methods of using the same in spinal decompression procedures
EP3033014B1 (en) 2013-08-16 2021-04-14 Suture Concepts Inc. Apparatus for closing a fissure in the annulus of an intervertebral disc, and/or for effecting other anatomical repairs and/or fixations
US10524772B2 (en) 2014-05-07 2020-01-07 Vertiflex, Inc. Spinal nerve decompression systems, dilation systems, and methods of using the same
PL3215067T3 (en) 2014-11-04 2020-11-02 Spinal Stabilization Technologies Llc Percutaneous implantable nuclear prosthesis
EP3215069B1 (en) 2014-11-04 2023-03-08 Spinal Stabilization Technologies LLC Percutaneous implantable nuclear prosthesis
KR102607758B1 (en) 2015-09-01 2023-11-29 스파이널 스태빌라이제이션 테크놀로지스, 엘엘씨 Implantable nuclear prosthesis
US9486323B1 (en) * 2015-11-06 2016-11-08 Spinal Stabilization Technologies Llc Nuclear implant apparatus and method following partial nuclectomy
AU2019384660A1 (en) 2018-09-04 2021-03-25 Spinal Stabilization Technologies, Llc Implantable nuclear prosthesis, kits, and related methods
WO2023037491A1 (en) * 2021-09-10 2023-03-16 株式会社Surfs Med Implant, medical device, and treatment method
CN115399855A (en) * 2022-09-15 2022-11-29 上海交通大学 Fibrous ring plugging and repairing device

Citations (98)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1995970A (en) * 1931-04-04 1935-03-26 Du Pont Polymeric lactide resin
US2703316A (en) * 1951-06-05 1955-03-01 Du Pont Polymers of high melting lactide
US3867728A (en) * 1971-12-30 1975-02-25 Cutter Lab Prosthesis for spinal repair
US4006747A (en) * 1975-04-23 1977-02-08 Ethicon, Inc. Surgical method
US4007743A (en) * 1975-10-20 1977-02-15 American Hospital Supply Corporation Opening mechanism for umbrella-like intravascular shunt defect closure device
US4013078A (en) * 1974-11-25 1977-03-22 Feild James Rodney Intervertebral protector means
US4369788A (en) * 1980-01-31 1983-01-25 Goald Harold J Reversed forceps for microdisc surgery
US4502161A (en) * 1981-09-21 1985-03-05 Wall W H Prosthetic meniscus for the repair of joints
US4798205A (en) * 1986-05-08 1989-01-17 Cox-Uphoff International Method of using a subperiosteal tissue expander
US4890612A (en) * 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US4895148A (en) * 1986-05-20 1990-01-23 Concept, Inc. Method of joining torn parts of bodily tissue in vivo with a biodegradable tack member
US4904261A (en) * 1987-08-06 1990-02-27 A. W. Showell (Surgicraft) Limited Spinal implants
US4904260A (en) * 1987-08-20 1990-02-27 Cedar Surgical, Inc. Prosthetic disc containing therapeutic material
US4911718A (en) * 1988-06-10 1990-03-27 University Of Medicine & Dentistry Of N.J. Functional and biocompatible intervertebral disc spacer
US5002576A (en) * 1988-06-06 1991-03-26 Mecron Medizinische Produkte Gmbh Intervertebral disk endoprosthesis
US5085661A (en) * 1990-10-29 1992-02-04 Gerald Moss Surgical fastener implantation device
US5100422A (en) * 1989-05-26 1992-03-31 Impra, Inc. Blood vessel patch
US5176691A (en) * 1990-09-11 1993-01-05 Pierce Instruments, Inc. Knot pusher
US5176692A (en) * 1991-12-09 1993-01-05 Wilk Peter J Method and surgical instrument for repairing hernia
US5192326A (en) * 1990-12-21 1993-03-09 Pfizer Hospital Products Group, Inc. Hydrogel bead intervertebral disc nucleus
US5195541A (en) * 1991-10-18 1993-03-23 Obenchain Theodore G Method of performing laparoscopic lumbar discectomy
US5282827A (en) * 1991-11-08 1994-02-01 Kensey Nash Corporation Hemostatic puncture closure system and method of use
US5282863A (en) * 1985-06-10 1994-02-01 Charles V. Burton Flexible stabilization system for a vertebral column
US5383477A (en) * 1991-08-02 1995-01-24 Dematteis; Ralph A. Method and apparatus for laparoscopic repair of hernias
US5383905A (en) * 1992-10-09 1995-01-24 United States Surgical Corporation Suture loop locking device
US5390683A (en) * 1991-02-22 1995-02-21 Pisharodi; Madhavan Spinal implantation methods utilizing a middle expandable implant
US5391182A (en) * 1993-08-03 1995-02-21 Origin Medsystems, Inc. Apparatus and method for closing puncture wounds
US5397332A (en) * 1993-09-02 1995-03-14 Ethicon, Inc. Surgical mesh applicator
US5397331A (en) * 1991-11-25 1995-03-14 Cook Incorporated Supporting device and apparatus for inserting the device
US5397991A (en) * 1988-07-13 1995-03-14 Electronic Development Inc. Multi-battery charging system for reduced fuel consumption and emissions in automotive vehicles
US5397326A (en) * 1993-04-15 1995-03-14 Mangum; William K. Knot pusher for videoendoscopic surgery
US5398861A (en) * 1993-04-16 1995-03-21 United States Surgical Corporation Device for driving surgical fasteners
US5489307A (en) * 1993-02-10 1996-02-06 Spine-Tech, Inc. Spinal stabilization surgical method
US5492697A (en) * 1990-03-05 1996-02-20 Board Of Regents, Univ. Of Texas System Biodegradable implant for fracture nonunions
US5496348A (en) * 1993-05-14 1996-03-05 Bonutti; Peter M. Suture anchor
US5500000A (en) * 1993-07-01 1996-03-19 United States Surgical Corporation Soft tissue repair system and method
US5591223A (en) * 1992-11-23 1997-01-07 Children's Medical Center Corporation Re-expandable endoprosthesis
US5591177A (en) * 1993-12-09 1997-01-07 Lehrer; Theodor Apparatus and method of extracorporeally applying and locking laparoscopic suture and loop ligatures
US5593425A (en) * 1990-06-28 1997-01-14 Peter M. Bonutti Surgical devices assembled using heat bonable materials
US5599279A (en) * 1994-03-16 1997-02-04 Gus J. Slotman Surgical instruments and method useful for endoscopic spinal procedures
US5613974A (en) * 1992-12-10 1997-03-25 Perclose, Inc. Apparatus and method for vascular closure
US5704943A (en) * 1995-09-25 1998-01-06 Yoon; Inbae Ligating instrument with multiple loop ligature supply and methods therefor
US5716404A (en) * 1994-12-16 1998-02-10 Massachusetts Institute Of Technology Breast tissue engineering
US5716409A (en) * 1996-10-16 1998-02-10 Debbas; Elie Reinforcement sheet for use in surgical repair
US5716416A (en) * 1996-09-10 1998-02-10 Lin; Chih-I Artificial intervertebral disk and method for implanting the same
US5716408A (en) * 1996-05-31 1998-02-10 C.R. Bard, Inc. Prosthesis for hernia repair and soft tissue reconstruction
US5716413A (en) * 1995-10-11 1998-02-10 Osteobiologics, Inc. Moldable, hand-shapable biodegradable implant material
US5725552A (en) * 1994-07-08 1998-03-10 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US5855614A (en) * 1993-02-22 1999-01-05 Heartport, Inc. Method and apparatus for thoracoscopic intracardiac procedures
US5860977A (en) * 1997-01-02 1999-01-19 Saint Francis Medical Technologies, Llc Spine distraction implant and method
US5861004A (en) * 1991-11-08 1999-01-19 Kensey Nash Corporation Hemostatic puncture closure system including closure locking means and method of use
US5860425A (en) * 1991-12-03 1999-01-19 Boston Scientific Technology, Inc. Bladder neck suspension procedure
US5865845A (en) * 1996-03-05 1999-02-02 Thalgott; John S. Prosthetic intervertebral disc
US5865846A (en) * 1994-11-14 1999-02-02 Bryan; Vincent Human spinal disc prosthesis
US5868762A (en) * 1997-09-25 1999-02-09 Sub-Q, Inc. Percutaneous hemostatic suturing device and method
US6019792A (en) * 1998-04-23 2000-02-01 Cauthen Research Group, Inc. Articulating spinal implant
US6019793A (en) * 1996-10-21 2000-02-01 Synthes Surgical prosthetic device
US6024754A (en) * 1996-01-18 2000-02-15 Target Therapeutics Inc. Aneurysm closure method
US6024758A (en) * 1998-02-23 2000-02-15 Thal; Raymond Two-part captured-loop knotless suture anchor assembly
US6024096A (en) * 1998-05-01 2000-02-15 Correstore Inc Anterior segment ventricular restoration apparatus and method
US6027527A (en) * 1996-12-06 2000-02-22 Piolax Inc. Stent
US6171329B1 (en) * 1994-12-19 2001-01-09 Gore Enterprise Holdings, Inc. Self-expanding defect closure device and method of making and using
US6171317B1 (en) * 1999-09-14 2001-01-09 Perclose, Inc. Knot tying device and method
US6171318B1 (en) * 1994-09-29 2001-01-09 Bard Asdi Inc. Hernia mesh patch with stiffening layer
US6174322B1 (en) * 1997-08-08 2001-01-16 Cardia, Inc. Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum
US6176863B1 (en) * 1994-09-29 2001-01-23 Bard Asdi Inc. Hernia mesh patch with I-shaped filament
US6179874B1 (en) * 1998-04-23 2001-01-30 Cauthen Research Group, Inc. Articulating spinal implant
US6179879B1 (en) * 1999-03-24 2001-01-30 Acushnet Company Leather impregnated with temperature stabilizing material and method for producing such leather
US6183518B1 (en) * 1999-02-22 2001-02-06 Anthony C. Ross Method of replacing nucleus pulposus and repairing the intervertebral disk
US6187048B1 (en) * 1994-05-24 2001-02-13 Surgical Dynamics, Inc. Intervertebral disc implant
US6190401B1 (en) * 1991-05-13 2001-02-20 United States Surgical Corporation Device for applying a meniscal staple
US6340369B1 (en) * 1999-08-13 2002-01-22 Bret A. Ferree Treating degenerative disc disease with harvested disc cells and analogues of the extracellular matrix
US6342064B1 (en) * 1998-12-22 2002-01-29 Nipro Corporation Closure device for transcatheter operation and catheter assembly therefor
US6344058B1 (en) * 1999-08-13 2002-02-05 Bret A. Ferree Treating degenerative disc disease through transplantation of allograft disc and vertebral endplates
US6344057B1 (en) * 1994-11-22 2002-02-05 Sdgi Holdings, Inc. Adjustable vertebral body replacement
US6506204B2 (en) * 1996-01-24 2003-01-14 Aga Medical Corporation Method and apparatus for occluding aneurysms
US6508828B1 (en) * 2000-11-03 2003-01-21 Radi Medical Systems Ab Sealing device and wound closure device
US6508839B1 (en) * 1999-08-18 2003-01-21 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation
US6511958B1 (en) * 1997-08-14 2003-01-28 Sulzer Biologics, Inc. Compositions for regeneration and repair of cartilage lesions
US6511488B1 (en) * 1998-06-23 2003-01-28 Orthopaedic Biosystems Ltd., Inc. Surgical knot manipulator
US6511498B1 (en) * 1998-02-06 2003-01-28 Laurent Fumex Surgical bone anchoring device
US6514255B1 (en) * 2000-02-25 2003-02-04 Bret Ferree Sublaminar spinal fixation apparatus
US6514514B1 (en) * 1997-08-14 2003-02-04 Sùlzer Biologics Inc. Device and method for regeneration and repair of cartilage lesions
US20030040796A1 (en) * 1999-10-08 2003-02-27 Ferree Bret A. Devices used to treat disc herniation and attachment mechanisms therefore
US6673088B1 (en) * 1999-05-18 2004-01-06 Cardica, Inc. Tissue punch
US6676665B2 (en) * 2000-08-11 2004-01-13 Sdgi Holdings, Inc. Surgical instrumentation and method for treatment of the spine
US6679914B1 (en) * 2000-11-14 2004-01-20 Shlomo Gabbay Implantable orthopedic support apparatus
US6684886B1 (en) * 2000-01-21 2004-02-03 Prospine, Inc. Intervertebral disc repair methods and apparatus
US6685695B2 (en) * 1999-08-13 2004-02-03 Bret A. Ferree Method and apparatus for providing nutrition to intervertebral disc tissue
US6689125B1 (en) * 2000-04-04 2004-02-10 Spinalabs, Llc Devices and methods for the treatment of spinal disorders
US6692506B1 (en) * 1998-02-03 2004-02-17 Sofradim Production Absorbable prosthetic mounting clip
US6695858B1 (en) * 1998-02-10 2004-02-24 Artemis Medical, Inc. Medical device and methods for use
US6696073B2 (en) * 1999-02-23 2004-02-24 Osteotech, Inc. Shaped load-bearing osteoimplant and methods of making same
US20040039392A1 (en) * 2000-10-27 2004-02-26 Trieu Hai H Annulus repair systems and methods
US6841150B2 (en) * 1999-08-19 2005-01-11 Artecal, Sciences, Inc. Use of adipose tissue-derived stromal cells for chondrocyte differentiation and cartilage repair
US6852128B2 (en) * 2001-02-28 2005-02-08 Sdgi Holdings, Inc. Flexible spine stabilization systems
US20050033440A1 (en) * 1999-08-18 2005-02-10 Lambrecht Gregory H. Intervertebral disc implant resistant to migration
US7004970B2 (en) * 1999-10-20 2006-02-28 Anulex Technologies, Inc. Methods and devices for spinal disc annulus reconstruction and repair

Family Cites Families (105)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4371430A (en) 1979-04-27 1983-02-01 Printing Developments, Inc. Electrodeposition of chromium on metal base lithographic sheet
GB2054383B (en) 1979-07-25 1983-08-03 Univ Exeter Plugs for the medullary canal of a bone
GB2058248B (en) 1979-09-12 1982-09-22 Butterworth System Inc Sealing arrangement
US4329574A (en) 1980-06-25 1982-05-11 International Business Machines Corp. Bar code candidate select circuit
EP0049978A1 (en) 1980-10-14 1982-04-21 Frank John Rowell Containers and method and machine for making them
DE3110767A1 (en) 1981-03-19 1982-09-30 Basf Ag, 6700 Ludwigshafen FIGHTING MUSHROOMS WITH 1,2-OXAZOLYLALKYLPHOSPHATES
DE3113902A1 (en) 1981-04-07 1982-10-28 Basf Ag, 6700 Ludwigshafen 1,3,4-THIADIAZOLYLMETHYL-THIOLPHOSPHORSAEUR DERIVATIVES, METHOD FOR THE PRODUCTION THEREOF AND THEIR USE FOR CONTROLLING PESTS
IT8153659V0 (en) 1981-10-05 1981-10-05 Indesit DISHWASHER DOOR OPENING DEVICE
US4520821A (en) * 1982-04-30 1985-06-04 The Regents Of The University Of California Growing of long-term biological tissue correction structures in vivo
US5601557A (en) * 1982-05-20 1997-02-11 Hayhurst; John O. Anchoring and manipulating tissue
DE3244032A1 (en) 1982-11-27 1984-05-30 Hoechst Ag, 6230 Frankfurt METHOD FOR PRODUCING PYRIDINE
JPS59112748A (en) 1982-12-06 1984-06-29 Fujitsu Ltd Data transmission and reception system
DE3311851A1 (en) 1983-03-31 1984-10-11 Computer Gesellschaft Konstanz Mbh, 7750 Konstanz TRANSPORT DEVICE IN THE AREA OF THE READING STATION OF A DOCUMENT PROCESSING DEVICE
FI74136B (en) 1983-04-19 1987-08-31 Tekma Oy GENOMKOERBAR KAMMARTORK FOER VIRKE.
US4513012A (en) 1983-05-13 1985-04-23 Warner-Lambert Company Powdered center-filled chewing gum compositions
DE3476351D1 (en) 1983-12-12 1989-03-02 Hugues Lesourd Deep-drawable metal article of the sandwich type, method and apparatus for the manufacture thereof
DE3575499D1 (en) 1984-09-19 1990-02-22 Honeywell Inc HIGH PERFORMANCE METAL OXYHALOGENIDE CELLS.
EP0193784A2 (en) 1985-03-04 1986-09-10 Siemens Aktiengesellschaft Connecting device for a high-tension machine
US5108438A (en) 1989-03-02 1992-04-28 Regen Corporation Prosthetic intervertebral disc
US5207695A (en) * 1989-06-19 1993-05-04 Trout Iii Hugh H Aortic graft, implantation device, and method for repairing aortic aneurysm
CA2078530A1 (en) * 1991-09-23 1993-03-24 Jay Erlebacher Percutaneous arterial puncture seal device and insertion tool therefore
US5411520A (en) * 1991-11-08 1995-05-02 Kensey Nash Corporation Hemostatic vessel puncture closure system utilizing a plug located within the puncture tract spaced from the vessel, and method of use
US5176682A (en) * 1992-06-01 1993-01-05 Chow James C Y Surgical implement
US5342393A (en) * 1992-08-27 1994-08-30 Duke University Method and device for vascular repair
US5534028A (en) 1993-04-20 1996-07-09 Howmedica, Inc. Hydrogel intervertebral disc nucleus with diminished lateral bulging
DE4323595C1 (en) 1993-07-15 1994-07-07 Eska Medical Gmbh & Co Partial spinal disc replacement
WO1995022285A1 (en) 1994-02-18 1995-08-24 Smith & Nephew Richards, Inc. Apparatus for treating herniated discs
US5888220A (en) 1994-05-06 1999-03-30 Advanced Bio Surfaces, Inc. Articulating joint repair
US5571189A (en) 1994-05-20 1996-11-05 Kuslich; Stephen D. Expandable fabric implant for stabilizing the spinal motion segment
AU5188196A (en) 1995-03-08 1996-09-23 Advanced Microbotics Corporation Spinal disc implant
US5782830A (en) 1995-10-16 1998-07-21 Sdgi Holdings, Inc. Implant insertion device
US5888222A (en) * 1995-10-16 1999-03-30 Sdgi Holding, Inc. Intervertebral spacers
JPH09157342A (en) 1995-12-07 1997-06-17 Nof Corp Aqueous dispersion of polyurethane resin, aqueous dispersionof polyurethane resin graft polymer, and aqueous coating composition
DE19604817C2 (en) * 1996-02-09 2003-06-12 Pfm Prod Fuer Die Med Ag Device for closing defect openings in the human or animal body
US5733294A (en) * 1996-02-28 1998-03-31 B. Braun Medical, Inc. Self expanding cardiovascular occlusion device, method of using and method of making the same
US5853422A (en) * 1996-03-22 1998-12-29 Scimed Life Systems, Inc. Apparatus and method for closing a septal defect
US5964807A (en) 1996-08-08 1999-10-12 Trustees Of The University Of Pennsylvania Compositions and methods for intervertebral disc reformation
US5718717A (en) * 1996-08-19 1998-02-17 Bonutti; Peter M. Suture anchor
AU4991997A (en) * 1996-10-22 1998-05-15 Surgical Dynamics, Inc. Apparatus for fusing adjacent bone structures
AU7178698A (en) 1996-11-15 1998-06-03 Advanced Bio Surfaces, Inc. Biomaterial system for in situ tissue repair
US5827328A (en) 1996-11-22 1998-10-27 Buttermann; Glenn R. Intervertebral prosthetic device
AU6042098A (en) * 1997-01-30 1998-08-25 Fujitsu Limited Data encoder/decoder for a high speed serial link
US6464712B1 (en) * 1997-02-11 2002-10-15 Biointerventional Corporation Expansile device for use in blood vessels and tracts in the body and method
US5957924A (en) * 1997-05-22 1999-09-28 Bionx Implants Oy Installation tool for suture anchor
EP1260181B1 (en) * 1997-06-02 2012-08-29 Jeannette M. D. Martello Soft tissue securing anchor
GB9713330D0 (en) 1997-06-25 1997-08-27 Bridport Gundry Plc Surgical implant
GB9714580D0 (en) 1997-07-10 1997-09-17 Wardlaw Douglas Prosthetic intervertebral disc nucleus
WO1999004720A1 (en) 1997-07-11 1999-02-04 Reprogenesis Inc. Repair of intervertebral disks
US6010525A (en) * 1997-08-01 2000-01-04 Peter M. Bonutti Method and apparatus for securing a suture
CA2304296C (en) 1997-10-01 2005-02-15 Boston Scientific Limited Pelvic floor reconstruction
US6027523A (en) * 1997-10-06 2000-02-22 Arthrex, Inc. Suture anchor with attached disk
US6159178A (en) * 1998-01-23 2000-12-12 Heartport, Inc. Methods and devices for occluding the ascending aorta and maintaining circulation of oxygenated blood in the patient when the patient's heart is arrested
US6241769B1 (en) * 1998-05-06 2001-06-05 Cortek, Inc. Implant for spinal fusion
US6224630B1 (en) 1998-05-29 2001-05-01 Advanced Bio Surfaces, Inc. Implantable tissue repair device
JP4768125B2 (en) 1998-10-06 2011-09-07 ラッシュ プレスバイテリアン セントルークス メディカルセンター Treatment of chemical nucleus pulposus
US6193757B1 (en) 1998-10-29 2001-02-27 Sdgi Holdings, Inc. Expandable intervertebral spacers
US6152144A (en) * 1998-11-06 2000-11-28 Appriva Medical, Inc. Method and device for left atrial appendage occlusion
US7128073B1 (en) * 1998-11-06 2006-10-31 Ev3 Endovascular, Inc. Method and device for left atrial appendage occlusion
ATE543442T1 (en) * 1998-12-31 2012-02-15 Kensey Nash Corp TISSUE FASTENING DEVICES
US6146422A (en) 1999-01-25 2000-11-14 Lawson; Kevin Jon Prosthetic nucleus replacement for surgical reconstruction of intervertebral discs and treatment method
WO2000049978A1 (en) 1999-02-22 2000-08-31 Guagliano Peter A Method of treating an intervertebral disk
US6110210A (en) 1999-04-08 2000-08-29 Raymedica, Inc. Prosthetic spinal disc nucleus having selectively coupled bodies
US6428576B1 (en) 1999-04-16 2002-08-06 Endospine, Ltd. System for repairing inter-vertebral discs
US6245107B1 (en) * 1999-05-28 2001-06-12 Bret A. Ferree Methods and apparatus for treating disc herniation
US7273497B2 (en) * 1999-05-28 2007-09-25 Anova Corp. Methods for treating a defect in the annulus fibrosis
AU4611899A (en) 1999-06-16 2001-01-02 Thomas Hoogland Method of and apparatus for decompressing herniated intervertebral discs
EP1328221B1 (en) * 1999-08-18 2009-03-25 Intrinsic Therapeutics, Inc. Devices for nucleus pulposus augmentation and retention
US6425919B1 (en) * 1999-08-18 2002-07-30 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation
US6783546B2 (en) * 1999-09-13 2004-08-31 Keraplast Technologies, Ltd. Implantable prosthetic or tissue expanding device
US6231561B1 (en) * 1999-09-20 2001-05-15 Appriva Medical, Inc. Method and apparatus for closing a body lumen
WO2001021246A1 (en) * 1999-09-20 2001-03-29 Nuvasive, Inc. Annulotomy closure device
US6264695B1 (en) 1999-09-30 2001-07-24 Replication Medical, Inc. Spinal nucleus implant
WO2001026570A1 (en) 1999-10-13 2001-04-19 Arthrocare Corporation Systems and methods for treating spinal pain
US7052516B2 (en) * 1999-10-20 2006-05-30 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
WO2001028464A1 (en) * 1999-10-20 2001-04-26 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and spinal disc annulus stent
US20030153976A1 (en) * 1999-10-20 2003-08-14 Cauthen Joseph C. Spinal disc annulus reconstruction method and spinal disc annulus stent
US6592625B2 (en) * 1999-10-20 2003-07-15 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and spinal disc annulus stent
US7887551B2 (en) * 1999-12-02 2011-02-15 Smith & Nephew, Inc. Soft tissue attachment and repair
JP4672947B2 (en) 1999-12-06 2011-04-20 ウォーソー・オーソペディック・インコーポレーテッド Intervertebral disc treatment apparatus and method
US6524317B1 (en) * 1999-12-30 2003-02-25 Opus Medical, Inc. Method and apparatus for attaching connective tissues to bone using a knotless suture anchoring device
US6805695B2 (en) * 2000-04-04 2004-10-19 Spinalabs, Llc Devices and methods for annular repair of intervertebral discs
US6533817B1 (en) 2000-06-05 2003-03-18 Raymedica, Inc. Packaged, partially hydrated prosthetic disc nucleus
DE60031175D1 (en) 2000-06-12 2006-11-16 Jeffrey E Yeung REPAIR OF INTERMEDIATE WHEELS
CN1192750C (en) 2000-08-28 2005-03-16 迪斯科动力学公司 Prosthesis of vertebral disc
US7597712B2 (en) * 2000-09-18 2009-10-06 Organogenesis, Inc. Method for treating a patient using a cultured connective tissue construct
FR2817142B1 (en) * 2000-11-24 2003-05-16 Sofradim Production PROSTHETIC FASTENER AND TRANSCUTANEOUS INSERTION DEVICE
HUP0302127A2 (en) * 2000-12-15 2005-12-28 Spineology, Inc. Annulus-reinforcing band
US20020147461A1 (en) * 2001-04-06 2002-10-10 Aldrich William N. Apparatus and methods for closing openings in spinal discs
US6726696B1 (en) * 2001-04-24 2004-04-27 Advanced Catheter Engineering, Inc. Patches and collars for medical applications and methods of use
US20030074075A1 (en) * 2001-08-27 2003-04-17 Thomas James C. Expandable implant for partial disc replacement and reinforcement of a disc partially removed in a discectomy and for reduction and maintenance of alignment of cancellous bone fractures and methods and apparatuses for same
US6685728B2 (en) * 2002-01-25 2004-02-03 Stryker Endoscopy Threaded suture anchor and method of use
US6843799B2 (en) * 2002-03-25 2005-01-18 Edwin C. Bartlett Suture anchor system and associated method
US7223289B2 (en) * 2002-04-16 2007-05-29 Warsaw Orthopedic, Inc. Annulus repair systems and techniques
US7033393B2 (en) * 2002-06-27 2006-04-25 Raymedica, Inc. Self-transitioning spinal disc anulus occulsion device and method of use
US20040138703A1 (en) * 2002-09-06 2004-07-15 Neville Alleyne Seal for posterior lateral vertebral disk cavity
US20040054414A1 (en) * 2002-09-18 2004-03-18 Trieu Hai H. Collagen-based materials and methods for augmenting intervertebral discs
US6966916B2 (en) * 2002-09-26 2005-11-22 Kumar Sarbjeet S Device and method for surgical repair of abdominal wall hernias
US20040210310A1 (en) * 2002-12-10 2004-10-21 Trieu Hai H. Implant system and method for intervertebral disc augmentation
ITPD20030039A1 (en) * 2003-02-28 2004-09-01 Maus Spa PROCESSING METHOD FOR SWARF REMOVAL OF
US7320701B2 (en) * 2003-06-02 2008-01-22 Linvatec Corporation Push-in suture anchor, insertion tool, and method for inserting a push-in suture anchor
DE10340150A1 (en) * 2003-08-26 2005-03-31 Aesculap Ag & Co. Kg Implant for closing an opening of the annulus fibrosus
US7322978B2 (en) * 2004-06-22 2008-01-29 Hs West Investments, Llc Bone anchors for use in attaching soft tissue to a bone
US20060247776A1 (en) * 2005-05-02 2006-11-02 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for augmenting intervertebral discs
US20070067040A1 (en) * 2005-09-02 2007-03-22 Anova Corporation Methods and apparatus for reconstructing the anulus fibrosus
US8197545B2 (en) * 2005-10-27 2012-06-12 Depuy Spine, Inc. Nucleus augmentation delivery device and technique

Patent Citations (100)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1995970A (en) * 1931-04-04 1935-03-26 Du Pont Polymeric lactide resin
US2703316A (en) * 1951-06-05 1955-03-01 Du Pont Polymers of high melting lactide
US3867728A (en) * 1971-12-30 1975-02-25 Cutter Lab Prosthesis for spinal repair
US4013078A (en) * 1974-11-25 1977-03-22 Feild James Rodney Intervertebral protector means
US4006747A (en) * 1975-04-23 1977-02-08 Ethicon, Inc. Surgical method
US4007743A (en) * 1975-10-20 1977-02-15 American Hospital Supply Corporation Opening mechanism for umbrella-like intravascular shunt defect closure device
US4369788A (en) * 1980-01-31 1983-01-25 Goald Harold J Reversed forceps for microdisc surgery
US4502161A (en) * 1981-09-21 1985-03-05 Wall W H Prosthetic meniscus for the repair of joints
US4502161B1 (en) * 1981-09-21 1989-07-25
US5282863A (en) * 1985-06-10 1994-02-01 Charles V. Burton Flexible stabilization system for a vertebral column
US4798205A (en) * 1986-05-08 1989-01-17 Cox-Uphoff International Method of using a subperiosteal tissue expander
US4895148A (en) * 1986-05-20 1990-01-23 Concept, Inc. Method of joining torn parts of bodily tissue in vivo with a biodegradable tack member
US4890612A (en) * 1987-02-17 1990-01-02 Kensey Nash Corporation Device for sealing percutaneous puncture in a vessel
US4904261A (en) * 1987-08-06 1990-02-27 A. W. Showell (Surgicraft) Limited Spinal implants
US4904260A (en) * 1987-08-20 1990-02-27 Cedar Surgical, Inc. Prosthetic disc containing therapeutic material
US5002576A (en) * 1988-06-06 1991-03-26 Mecron Medizinische Produkte Gmbh Intervertebral disk endoprosthesis
US4911718A (en) * 1988-06-10 1990-03-27 University Of Medicine & Dentistry Of N.J. Functional and biocompatible intervertebral disc spacer
US5397991A (en) * 1988-07-13 1995-03-14 Electronic Development Inc. Multi-battery charging system for reduced fuel consumption and emissions in automotive vehicles
US5100422A (en) * 1989-05-26 1992-03-31 Impra, Inc. Blood vessel patch
US5492697A (en) * 1990-03-05 1996-02-20 Board Of Regents, Univ. Of Texas System Biodegradable implant for fracture nonunions
US5593425A (en) * 1990-06-28 1997-01-14 Peter M. Bonutti Surgical devices assembled using heat bonable materials
US5176691A (en) * 1990-09-11 1993-01-05 Pierce Instruments, Inc. Knot pusher
US5085661A (en) * 1990-10-29 1992-02-04 Gerald Moss Surgical fastener implantation device
US5192326A (en) * 1990-12-21 1993-03-09 Pfizer Hospital Products Group, Inc. Hydrogel bead intervertebral disc nucleus
US5390683A (en) * 1991-02-22 1995-02-21 Pisharodi; Madhavan Spinal implantation methods utilizing a middle expandable implant
US6190401B1 (en) * 1991-05-13 2001-02-20 United States Surgical Corporation Device for applying a meniscal staple
US5383477A (en) * 1991-08-02 1995-01-24 Dematteis; Ralph A. Method and apparatus for laparoscopic repair of hernias
US5195541A (en) * 1991-10-18 1993-03-23 Obenchain Theodore G Method of performing laparoscopic lumbar discectomy
US5861004A (en) * 1991-11-08 1999-01-19 Kensey Nash Corporation Hemostatic puncture closure system including closure locking means and method of use
US5282827A (en) * 1991-11-08 1994-02-01 Kensey Nash Corporation Hemostatic puncture closure system and method of use
US5397331A (en) * 1991-11-25 1995-03-14 Cook Incorporated Supporting device and apparatus for inserting the device
US5860425A (en) * 1991-12-03 1999-01-19 Boston Scientific Technology, Inc. Bladder neck suspension procedure
US5176692A (en) * 1991-12-09 1993-01-05 Wilk Peter J Method and surgical instrument for repairing hernia
US5383905A (en) * 1992-10-09 1995-01-24 United States Surgical Corporation Suture loop locking device
US5591223A (en) * 1992-11-23 1997-01-07 Children's Medical Center Corporation Re-expandable endoprosthesis
US5613974A (en) * 1992-12-10 1997-03-25 Perclose, Inc. Apparatus and method for vascular closure
US5489307A (en) * 1993-02-10 1996-02-06 Spine-Tech, Inc. Spinal stabilization surgical method
US5855614A (en) * 1993-02-22 1999-01-05 Heartport, Inc. Method and apparatus for thoracoscopic intracardiac procedures
US5397326A (en) * 1993-04-15 1995-03-14 Mangum; William K. Knot pusher for videoendoscopic surgery
US5398861A (en) * 1993-04-16 1995-03-21 United States Surgical Corporation Device for driving surgical fasteners
US5496348A (en) * 1993-05-14 1996-03-05 Bonutti; Peter M. Suture anchor
US5500000A (en) * 1993-07-01 1996-03-19 United States Surgical Corporation Soft tissue repair system and method
US5391182A (en) * 1993-08-03 1995-02-21 Origin Medsystems, Inc. Apparatus and method for closing puncture wounds
US5397332A (en) * 1993-09-02 1995-03-14 Ethicon, Inc. Surgical mesh applicator
US5591177A (en) * 1993-12-09 1997-01-07 Lehrer; Theodor Apparatus and method of extracorporeally applying and locking laparoscopic suture and loop ligatures
US5599279A (en) * 1994-03-16 1997-02-04 Gus J. Slotman Surgical instruments and method useful for endoscopic spinal procedures
US6187048B1 (en) * 1994-05-24 2001-02-13 Surgical Dynamics, Inc. Intervertebral disc implant
US5725552A (en) * 1994-07-08 1998-03-10 Aga Medical Corporation Percutaneous catheter directed intravascular occlusion devices
US6176863B1 (en) * 1994-09-29 2001-01-23 Bard Asdi Inc. Hernia mesh patch with I-shaped filament
US6171318B1 (en) * 1994-09-29 2001-01-09 Bard Asdi Inc. Hernia mesh patch with stiffening layer
US5865846A (en) * 1994-11-14 1999-02-02 Bryan; Vincent Human spinal disc prosthesis
US6344057B1 (en) * 1994-11-22 2002-02-05 Sdgi Holdings, Inc. Adjustable vertebral body replacement
US5716404A (en) * 1994-12-16 1998-02-10 Massachusetts Institute Of Technology Breast tissue engineering
US6171329B1 (en) * 1994-12-19 2001-01-09 Gore Enterprise Holdings, Inc. Self-expanding defect closure device and method of making and using
US5704943A (en) * 1995-09-25 1998-01-06 Yoon; Inbae Ligating instrument with multiple loop ligature supply and methods therefor
US5716413A (en) * 1995-10-11 1998-02-10 Osteobiologics, Inc. Moldable, hand-shapable biodegradable implant material
US6024754A (en) * 1996-01-18 2000-02-15 Target Therapeutics Inc. Aneurysm closure method
US6506204B2 (en) * 1996-01-24 2003-01-14 Aga Medical Corporation Method and apparatus for occluding aneurysms
US5865845A (en) * 1996-03-05 1999-02-02 Thalgott; John S. Prosthetic intervertebral disc
US5716408A (en) * 1996-05-31 1998-02-10 C.R. Bard, Inc. Prosthesis for hernia repair and soft tissue reconstruction
US5716416A (en) * 1996-09-10 1998-02-10 Lin; Chih-I Artificial intervertebral disk and method for implanting the same
US5716409A (en) * 1996-10-16 1998-02-10 Debbas; Elie Reinforcement sheet for use in surgical repair
US6019793A (en) * 1996-10-21 2000-02-01 Synthes Surgical prosthetic device
US6027527A (en) * 1996-12-06 2000-02-22 Piolax Inc. Stent
US5860977A (en) * 1997-01-02 1999-01-19 Saint Francis Medical Technologies, Llc Spine distraction implant and method
US6174322B1 (en) * 1997-08-08 2001-01-16 Cardia, Inc. Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum
US6511958B1 (en) * 1997-08-14 2003-01-28 Sulzer Biologics, Inc. Compositions for regeneration and repair of cartilage lesions
US6514514B1 (en) * 1997-08-14 2003-02-04 Sùlzer Biologics Inc. Device and method for regeneration and repair of cartilage lesions
US5868762A (en) * 1997-09-25 1999-02-09 Sub-Q, Inc. Percutaneous hemostatic suturing device and method
US6692506B1 (en) * 1998-02-03 2004-02-17 Sofradim Production Absorbable prosthetic mounting clip
US6511498B1 (en) * 1998-02-06 2003-01-28 Laurent Fumex Surgical bone anchoring device
US6695858B1 (en) * 1998-02-10 2004-02-24 Artemis Medical, Inc. Medical device and methods for use
US6024758A (en) * 1998-02-23 2000-02-15 Thal; Raymond Two-part captured-loop knotless suture anchor assembly
US6019792A (en) * 1998-04-23 2000-02-01 Cauthen Research Group, Inc. Articulating spinal implant
US6179874B1 (en) * 1998-04-23 2001-01-30 Cauthen Research Group, Inc. Articulating spinal implant
US6024096A (en) * 1998-05-01 2000-02-15 Correstore Inc Anterior segment ventricular restoration apparatus and method
US6511488B1 (en) * 1998-06-23 2003-01-28 Orthopaedic Biosystems Ltd., Inc. Surgical knot manipulator
US6342064B1 (en) * 1998-12-22 2002-01-29 Nipro Corporation Closure device for transcatheter operation and catheter assembly therefor
US6183518B1 (en) * 1999-02-22 2001-02-06 Anthony C. Ross Method of replacing nucleus pulposus and repairing the intervertebral disk
US6696073B2 (en) * 1999-02-23 2004-02-24 Osteotech, Inc. Shaped load-bearing osteoimplant and methods of making same
US6179879B1 (en) * 1999-03-24 2001-01-30 Acushnet Company Leather impregnated with temperature stabilizing material and method for producing such leather
US6673088B1 (en) * 1999-05-18 2004-01-06 Cardica, Inc. Tissue punch
US6344058B1 (en) * 1999-08-13 2002-02-05 Bret A. Ferree Treating degenerative disc disease through transplantation of allograft disc and vertebral endplates
US6340369B1 (en) * 1999-08-13 2002-01-22 Bret A. Ferree Treating degenerative disc disease with harvested disc cells and analogues of the extracellular matrix
US6685695B2 (en) * 1999-08-13 2004-02-03 Bret A. Ferree Method and apparatus for providing nutrition to intervertebral disc tissue
US20050038519A1 (en) * 1999-08-18 2005-02-17 Lambrecht Gregory H. Method of reducing spinal implant migration
US20050033440A1 (en) * 1999-08-18 2005-02-10 Lambrecht Gregory H. Intervertebral disc implant resistant to migration
US6508839B1 (en) * 1999-08-18 2003-01-21 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation
US6841150B2 (en) * 1999-08-19 2005-01-11 Artecal, Sciences, Inc. Use of adipose tissue-derived stromal cells for chondrocyte differentiation and cartilage repair
US6171317B1 (en) * 1999-09-14 2001-01-09 Perclose, Inc. Knot tying device and method
US20030040796A1 (en) * 1999-10-08 2003-02-27 Ferree Bret A. Devices used to treat disc herniation and attachment mechanisms therefore
US7004970B2 (en) * 1999-10-20 2006-02-28 Anulex Technologies, Inc. Methods and devices for spinal disc annulus reconstruction and repair
US6684886B1 (en) * 2000-01-21 2004-02-03 Prospine, Inc. Intervertebral disc repair methods and apparatus
US6514255B1 (en) * 2000-02-25 2003-02-04 Bret Ferree Sublaminar spinal fixation apparatus
US6689125B1 (en) * 2000-04-04 2004-02-10 Spinalabs, Llc Devices and methods for the treatment of spinal disorders
US6676665B2 (en) * 2000-08-11 2004-01-13 Sdgi Holdings, Inc. Surgical instrumentation and method for treatment of the spine
US20040039392A1 (en) * 2000-10-27 2004-02-26 Trieu Hai H Annulus repair systems and methods
US6508828B1 (en) * 2000-11-03 2003-01-21 Radi Medical Systems Ab Sealing device and wound closure device
US6679914B1 (en) * 2000-11-14 2004-01-20 Shlomo Gabbay Implantable orthopedic support apparatus
US6852128B2 (en) * 2001-02-28 2005-02-08 Sdgi Holdings, Inc. Flexible spine stabilization systems

Cited By (153)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7985257B2 (en) 1999-10-20 2011-07-26 Anulex Technologies, Inc. Methods and devices for spinal disc annulus reconstruction and repair
US20070061012A1 (en) * 1999-10-20 2007-03-15 Cauthen Joseph C Iii Intervertebral disc annulus stent
US7909879B2 (en) 1999-10-20 2011-03-22 Anulex Technologies, Inc. Intervertebral disc annulus stent
US9114025B2 (en) 1999-10-20 2015-08-25 Krt Investors, Inc. Methods and devices for spinal disc annulus reconstruction and repair
US7922768B2 (en) 1999-10-20 2011-04-12 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US8088165B2 (en) 1999-10-20 2012-01-03 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US8632590B2 (en) 1999-10-20 2014-01-21 Anulex Technologies, Inc. Apparatus and methods for the treatment of the intervertebral disc
US8048160B2 (en) 1999-10-20 2011-11-01 Anulex Technologies, Inc. Intervertebral disc annulus stent
US8034112B2 (en) 1999-10-20 2011-10-11 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and spinal disc annulus stent
US7828850B2 (en) 1999-10-20 2010-11-09 Anulex Technologies, Inc. Methods and devices for spinal disc annulus reconstruction and repair
US7993405B2 (en) 1999-10-20 2011-08-09 Anulex Technologies, Inc. Spinal disc annulus repair system and methods
US8556977B2 (en) 1999-10-20 2013-10-15 Anulex Technologies, Inc. Tissue anchoring system and method
US7846208B2 (en) 1999-10-20 2010-12-07 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US20060287731A1 (en) * 1999-10-20 2006-12-21 Cauthen Joseph C Iii Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US8128698B2 (en) 1999-10-20 2012-03-06 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US7935147B2 (en) 1999-10-20 2011-05-03 Anulex Technologies, Inc. Method and apparatus for enhanced delivery of treatment device to the intervertebral disc annulus
US9675347B2 (en) 1999-10-20 2017-06-13 Krt Investors, Inc. Apparatus for the treatment of tissue
US7670380B2 (en) 1999-10-20 2010-03-02 Anulex Technologies, Inc. Intervertebral disc annulus stent
US7670379B2 (en) 1999-10-20 2010-03-02 Anulex Technologies, Inc. Spinal disc annulus reconstruction method
US7963992B2 (en) 1999-10-20 2011-06-21 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US7951201B2 (en) 1999-10-20 2011-05-31 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US7749273B2 (en) 1999-10-20 2010-07-06 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US20080009944A1 (en) * 2001-10-02 2008-01-10 Rex Medical Spinal implant and method of use
US9095449B2 (en) 2001-10-02 2015-08-04 Rex Medical, L. P. Method of inserting a spinal implant
US20060129242A1 (en) * 2001-12-28 2006-06-15 Brian Bergeron Pseudo arthrosis device
US8012211B2 (en) * 2002-11-05 2011-09-06 Spineology, Inc. Semi-biological intervertebral disc replacement system
US10555817B2 (en) 2003-02-14 2020-02-11 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10433971B2 (en) 2003-02-14 2019-10-08 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9814590B2 (en) 2003-02-14 2017-11-14 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9814589B2 (en) 2003-02-14 2017-11-14 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9925060B2 (en) 2003-02-14 2018-03-27 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9801729B2 (en) 2003-02-14 2017-10-31 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9788963B2 (en) 2003-02-14 2017-10-17 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10085843B2 (en) 2003-02-14 2018-10-02 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10376372B2 (en) 2003-02-14 2019-08-13 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10405986B2 (en) 2003-02-14 2019-09-10 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10420651B2 (en) 2003-02-14 2019-09-24 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US9808351B2 (en) 2003-02-14 2017-11-07 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10492918B2 (en) 2003-02-14 2019-12-03 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US11432938B2 (en) 2003-02-14 2022-09-06 DePuy Synthes Products, Inc. In-situ intervertebral fusion device and method
US10575959B2 (en) 2003-02-14 2020-03-03 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10583013B2 (en) 2003-02-14 2020-03-10 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10639164B2 (en) 2003-02-14 2020-05-05 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US10786361B2 (en) 2003-02-14 2020-09-29 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US11096794B2 (en) 2003-02-14 2021-08-24 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US11207187B2 (en) 2003-02-14 2021-12-28 DePuy Synthes Products, Inc. In-situ formed intervertebral fusion device and method
US7988735B2 (en) * 2005-06-15 2011-08-02 Matthew Yurek Mechanical apparatus and method for delivering materials into the inter-vertebral body space for nucleus replacement
US9259326B2 (en) 2005-08-16 2016-02-16 Benvenue Medical, Inc. Spinal tissue distraction devices
US7967865B2 (en) 2005-08-16 2011-06-28 Benvenue Medical, Inc. Devices for limiting the movement of material introduced between layers of spinal tissue
US7666226B2 (en) 2005-08-16 2010-02-23 Benvenue Medical, Inc. Spinal tissue distraction devices
US8366773B2 (en) 2005-08-16 2013-02-05 Benvenue Medical, Inc. Apparatus and method for treating bone
US8454617B2 (en) 2005-08-16 2013-06-04 Benvenue Medical, Inc. Devices for treating the spine
US7666227B2 (en) 2005-08-16 2010-02-23 Benvenue Medical, Inc. Devices for limiting the movement of material introduced between layers of spinal tissue
US7670375B2 (en) 2005-08-16 2010-03-02 Benvenue Medical, Inc. Methods for limiting the movement of material introduced between layers of spinal tissue
US10028840B2 (en) 2005-08-16 2018-07-24 Izi Medical Products, Llc Spinal tissue distraction devices
US7670374B2 (en) 2005-08-16 2010-03-02 Benvenue Medical, Inc. Methods of distracting tissue layers of the human spine
US8556978B2 (en) 2005-08-16 2013-10-15 Benvenue Medical, Inc. Devices and methods for treating the vertebral body
US7785368B2 (en) 2005-08-16 2010-08-31 Benvenue Medical, Inc. Spinal tissue distraction devices
US8591583B2 (en) 2005-08-16 2013-11-26 Benvenue Medical, Inc. Devices for treating the spine
US8057544B2 (en) 2005-08-16 2011-11-15 Benvenue Medical, Inc. Methods of distracting tissue layers of the human spine
US7955391B2 (en) 2005-08-16 2011-06-07 Benvenue Medical, Inc. Methods for limiting the movement of material introduced between layers of spinal tissue
US8801787B2 (en) 2005-08-16 2014-08-12 Benvenue Medical, Inc. Methods of distracting tissue layers of the human spine
US8808376B2 (en) 2005-08-16 2014-08-19 Benvenue Medical, Inc. Intravertebral implants
US9788974B2 (en) 2005-08-16 2017-10-17 Benvenue Medical, Inc. Spinal tissue distraction devices
US8882836B2 (en) 2005-08-16 2014-11-11 Benvenue Medical, Inc. Apparatus and method for treating bone
US7963993B2 (en) 2005-08-16 2011-06-21 Benvenue Medical, Inc. Methods of distracting tissue layers of the human spine
US8961609B2 (en) 2005-08-16 2015-02-24 Benvenue Medical, Inc. Devices for distracting tissue layers of the human spine
US9326866B2 (en) 2005-08-16 2016-05-03 Benvenue Medical, Inc. Devices for treating the spine
US8979929B2 (en) 2005-08-16 2015-03-17 Benvenue Medical, Inc. Spinal tissue distraction devices
US7967864B2 (en) 2005-08-16 2011-06-28 Benvenue Medical, Inc. Spinal tissue distraction devices
US9044338B2 (en) 2005-08-16 2015-06-02 Benvenue Medical, Inc. Spinal tissue distraction devices
US9066808B2 (en) 2005-08-16 2015-06-30 Benvenue Medical, Inc. Method of interdigitating flowable material with bone tissue
US7963991B2 (en) 2005-08-26 2011-06-21 Magellan Spine Technologies, Inc. Spinal implants and methods of providing dynamic stability to the spine
US20090171461A1 (en) * 2005-08-26 2009-07-02 Magellan Spine Technologies, Inc. Spinal implants and methods
US20080071377A1 (en) * 2005-08-26 2008-03-20 Magellan Spine Technologies, Inc. Spinal implants and methods of providing dynamic stability to the spine
US20070244562A1 (en) * 2005-08-26 2007-10-18 Magellan Spine Technologies, Inc. Spinal implants and methods of providing dynamic stability to the spine
US8287599B2 (en) 2006-11-16 2012-10-16 Rex Medical, L.P. Spinal implant and method of use
US20150094817A1 (en) * 2006-11-16 2015-04-02 Rex Medical, L.P. Spinal implant and method of use
US20080133012A1 (en) * 2006-11-16 2008-06-05 Mcguckin James F Spinal implant and method of use
US9259324B2 (en) * 2006-11-16 2016-02-16 Rex Medical, L.P. Spinal implant and method of use
US8142507B2 (en) * 2006-11-16 2012-03-27 Rex Medical, L.P. Spinal implant and method of use
US8920506B2 (en) 2006-11-16 2014-12-30 Rex Medical, L.P. Spinal implant and method of use
US11642229B2 (en) 2006-12-07 2023-05-09 DePuy Synthes Products, Inc. Intervertebral implant
US11660206B2 (en) 2006-12-07 2023-05-30 DePuy Synthes Products, Inc. Intervertebral implant
US11273050B2 (en) 2006-12-07 2022-03-15 DePuy Synthes Products, Inc. Intervertebral implant
US11432942B2 (en) 2006-12-07 2022-09-06 DePuy Synthes Products, Inc. Intervertebral implant
US11712345B2 (en) 2006-12-07 2023-08-01 DePuy Synthes Products, Inc. Intervertebral implant
US11497618B2 (en) 2006-12-07 2022-11-15 DePuy Synthes Products, Inc. Intervertebral implant
US20080154376A1 (en) * 2006-12-20 2008-06-26 Bergeron Brian J Surgical implant suitable for replacement of an intervertebral disc
US7905922B2 (en) * 2006-12-20 2011-03-15 Zimmer Spine, Inc. Surgical implant suitable for replacement of an intervertebral disc
US8968408B2 (en) 2007-02-21 2015-03-03 Benvenue Medical, Inc. Devices for treating the spine
US9642712B2 (en) 2007-02-21 2017-05-09 Benvenue Medical, Inc. Methods for treating the spine
US10575963B2 (en) 2007-02-21 2020-03-03 Benvenue Medical, Inc. Devices for treating the spine
US10426629B2 (en) 2007-02-21 2019-10-01 Benvenue Medical, Inc. Devices for treating the spine
US10285821B2 (en) 2007-02-21 2019-05-14 Benvenue Medical, Inc. Devices for treating the spine
WO2008142233A3 (en) * 2007-03-27 2009-01-29 Cie De Rech En Composants Impl Implantable reinforcement prosthesis with fixation means
WO2008142233A2 (en) * 2007-03-27 2008-11-27 Compagnie De Recherche En Composants, Implants Et Materiels Pour L'application Clinique Implantable reinforcement prosthesis with fixation means
FR2914178A1 (en) * 2007-03-27 2008-10-03 Cie De Rech En Composants Impl Reinforcement implantable prosthesis i.e. parietal prosthesis, for e.g. anesthesia patient, has fixation unit passed via attachment orifice and supported against biological tissue at periphery of orifice to form anti-return unit
US11622868B2 (en) 2007-06-26 2023-04-11 DePuy Synthes Products, Inc. Highly lordosed fusion cage
US10973652B2 (en) 2007-06-26 2021-04-13 DePuy Synthes Products, Inc. Highly lordosed fusion cage
US20090270989A1 (en) * 2007-11-19 2009-10-29 Magellan Spine Technologies, Inc. Spinal implants and methods
US20090149959A1 (en) * 2007-11-19 2009-06-11 Magellan Spine Technologies, Inc. Spinal implants and methods
US20090138084A1 (en) * 2007-11-19 2009-05-28 Magellan Spine Technologies, Inc. Spinal implants and methods
US11737881B2 (en) 2008-01-17 2023-08-29 DePuy Synthes Products, Inc. Expandable intervertebral implant and associated method of manufacturing the same
US11712342B2 (en) 2008-04-05 2023-08-01 DePuy Synthes Products, Inc. Expandable intervertebral implant
US11602438B2 (en) 2008-04-05 2023-03-14 DePuy Synthes Products, Inc. Expandable intervertebral implant
US11712341B2 (en) 2008-04-05 2023-08-01 DePuy Synthes Products, Inc. Expandable intervertebral implant
US11701234B2 (en) 2008-04-05 2023-07-18 DePuy Synthes Products, Inc. Expandable intervertebral implant
US11617655B2 (en) 2008-04-05 2023-04-04 DePuy Synthes Products, Inc. Expandable intervertebral implant
US11707359B2 (en) 2008-04-05 2023-07-25 DePuy Synthes Products, Inc. Expandable intervertebral implant
US8454697B2 (en) 2008-10-14 2013-06-04 Anulex Technologies, Inc. Method and apparatus for the treatment of tissue
US9192372B2 (en) 2008-10-14 2015-11-24 Krt Investors, Inc. Method for the treatment of tissue
US8163022B2 (en) 2008-10-14 2012-04-24 Anulex Technologies, Inc. Method and apparatus for the treatment of the intervertebral disc annulus
US8535327B2 (en) 2009-03-17 2013-09-17 Benvenue Medical, Inc. Delivery apparatus for use with implantable medical devices
US11612491B2 (en) 2009-03-30 2023-03-28 DePuy Synthes Products, Inc. Zero profile spinal fusion cage
US20100286779A1 (en) * 2009-05-06 2010-11-11 Thibodeau Lee L Expandable spinal implant apparatus and method of use
US9603715B2 (en) 2009-05-06 2017-03-28 Stryker European Holdings I, Llc Expandable spinal implant apparatus and method of use
US9050194B2 (en) 2009-05-06 2015-06-09 Stryker Spine Expandable spinal implant apparatus and method of use
US10413419B2 (en) 2009-05-06 2019-09-17 Stryker European Holdings I, Llc Expandable spinal implant apparatus and method of use
US11464646B2 (en) 2009-05-06 2022-10-11 Stryker European Operations Holdings Llc Expandable spinal implant apparatus and method of use
US9078761B2 (en) 2009-11-12 2015-07-14 Anchor Orthopedics Xt Inc. Devices and methods for treating tissue defects
US11607321B2 (en) 2009-12-10 2023-03-21 DePuy Synthes Products, Inc. Bellows-like expandable interbody fusion cage
US20110153017A1 (en) * 2009-12-22 2011-06-23 Mcclellan William T Systems and methods for tissue expansion with fluid delivery and drainage system
US8454690B2 (en) 2009-12-22 2013-06-04 William T. MCCLELLAN Systems and methods for tissue expansion with fluid delivery and drainage system
US8460319B2 (en) 2010-01-11 2013-06-11 Anulex Technologies, Inc. Intervertebral disc annulus repair system and method
US9795372B2 (en) 2010-01-11 2017-10-24 Krt Investors, Inc. Intervertebral disc annulus repair system and bone anchor delivery tool
US8652153B2 (en) 2010-01-11 2014-02-18 Anulex Technologies, Inc. Intervertebral disc annulus repair system and bone anchor delivery tool
US10966840B2 (en) 2010-06-24 2021-04-06 DePuy Synthes Products, Inc. Enhanced cage insertion assembly
US11872139B2 (en) 2010-06-24 2024-01-16 DePuy Synthes Products, Inc. Enhanced cage insertion assembly
US11911287B2 (en) 2010-06-24 2024-02-27 DePuy Synthes Products, Inc. Lateral spondylolisthesis reduction cage
US11654033B2 (en) 2010-06-29 2023-05-23 DePuy Synthes Products, Inc. Distractible intervertebral implant
US11452607B2 (en) 2010-10-11 2022-09-27 DePuy Synthes Products, Inc. Expandable interspinous process spacer implant
US9314252B2 (en) 2011-06-24 2016-04-19 Benvenue Medical, Inc. Devices and methods for treating bone tissue
US8814873B2 (en) 2011-06-24 2014-08-26 Benvenue Medical, Inc. Devices and methods for treating bone tissue
US11471199B2 (en) 2013-01-28 2022-10-18 Cartiva, Inc. Systems and methods for orthopedic repair
US9737294B2 (en) 2013-01-28 2017-08-22 Cartiva, Inc. Method and system for orthopedic repair
US10179012B2 (en) 2013-01-28 2019-01-15 Cartiva, Inc. Systems and methods for orthopedic repair
US11850164B2 (en) 2013-03-07 2023-12-26 DePuy Synthes Products, Inc. Intervertebral implant
US11497619B2 (en) 2013-03-07 2022-11-15 DePuy Synthes Products, Inc. Intervertebral implant
US10085783B2 (en) 2013-03-14 2018-10-02 Izi Medical Products, Llc Devices and methods for treating bone tissue
US11426290B2 (en) 2015-03-06 2022-08-30 DePuy Synthes Products, Inc. Expandable intervertebral implant, system, kit and method
US11596522B2 (en) 2016-06-28 2023-03-07 Eit Emerging Implant Technologies Gmbh Expandable and angularly adjustable intervertebral cages with articulating joint
US11596523B2 (en) 2016-06-28 2023-03-07 Eit Emerging Implant Technologies Gmbh Expandable and angularly adjustable articulating intervertebral cages
US11510788B2 (en) 2016-06-28 2022-11-29 Eit Emerging Implant Technologies Gmbh Expandable, angularly adjustable intervertebral cages
US10888433B2 (en) 2016-12-14 2021-01-12 DePuy Synthes Products, Inc. Intervertebral implant inserter and related methods
US11446155B2 (en) 2017-05-08 2022-09-20 Medos International Sarl Expandable cage
US11344424B2 (en) 2017-06-14 2022-05-31 Medos International Sarl Expandable intervertebral implant and related methods
US10940016B2 (en) 2017-07-05 2021-03-09 Medos International Sarl Expandable intervertebral fusion cage
US11446156B2 (en) 2018-10-25 2022-09-20 Medos International Sarl Expandable intervertebral implant, inserter instrument, and related methods
US11806245B2 (en) 2020-03-06 2023-11-07 Eit Emerging Implant Technologies Gmbh Expandable intervertebral implant
US11426286B2 (en) 2020-03-06 2022-08-30 Eit Emerging Implant Technologies Gmbh Expandable intervertebral implant
US11850160B2 (en) 2021-03-26 2023-12-26 Medos International Sarl Expandable lordotic intervertebral fusion cage
US11752009B2 (en) 2021-04-06 2023-09-12 Medos International Sarl Expandable intervertebral fusion cage

Also Published As

Publication number Publication date
US20030153976A1 (en) 2003-08-14
IL169904A0 (en) 2007-07-04
WO2004069026A2 (en) 2004-08-19
JP2007501101A (en) 2007-01-25
AU2004210109B2 (en) 2010-09-16
WO2004069026A3 (en) 2005-04-07
US20060287731A1 (en) 2006-12-21
CA2512142A1 (en) 2004-08-19
US7846208B2 (en) 2010-12-07
EP1594422A2 (en) 2005-11-16
EP1594422A4 (en) 2007-10-17
AU2004210109A1 (en) 2004-08-19

Similar Documents

Publication Publication Date Title
US7846208B2 (en) Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US7922768B2 (en) Spinal disc annulus reconstruction method and deformable spinal disc annulus stent
US7993405B2 (en) Spinal disc annulus repair system and methods
US20090024216A1 (en) Spinal disc annulus reconstruction method and spinal disc annulus stent
WO2003011155A2 (en) Spinal disc annulus reconstruction method and spinal disc annulus stent
AU2012261709B2 (en) Spinal disc annulus reconstruction method and spinal disc annulus stent
EP1416867B1 (en) Spinal disc annulus reconstruction
AU2002355710A1 (en) Spinal disc annulus reconstruction method and spinal disc annulus stent
AU2009202132A1 (en) Spinal disc annulus reconstruction method and spinal disc annulus stent

Legal Events

Date Code Title Description
AS Assignment

Owner name: ANULEX TECHNOLOGIES, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CAUTHEN, JOSEPH C., III;BURNS, MATTHEW M.;WALES, LAWRENCE W.;AND OTHERS;REEL/FRAME:018689/0190;SIGNING DATES FROM 20030212 TO 20030226

Owner name: ANULEX TECHNOLOGIES, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PROTOSTAR, INC.;REEL/FRAME:018689/0137

Effective date: 20010316

Owner name: CAUTHEN RESEARCH GROUP, INC., FLORIDA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CAUTHEN, JOSEPH C.;REEL/FRAME:018689/0001

Effective date: 20001016

Owner name: PROTOSTAR, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CAUTHEN RESEARCH GROUP;REEL/FRAME:018689/0120

Effective date: 20010315

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION