WO2010027622A1 - Retention structure for in situ formation of an intervertebral prosthesis - Google Patents

Retention structure for in situ formation of an intervertebral prosthesis Download PDF

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Publication number
WO2010027622A1
WO2010027622A1 PCT/US2009/053768 US2009053768W WO2010027622A1 WO 2010027622 A1 WO2010027622 A1 WO 2010027622A1 US 2009053768 W US2009053768 W US 2009053768W WO 2010027622 A1 WO2010027622 A1 WO 2010027622A1
Authority
WO
WIPO (PCT)
Prior art keywords
retention structure
assembly
biomaterial
intervertebral disc
disc space
Prior art date
Application number
PCT/US2009/053768
Other languages
French (fr)
Inventor
Michael Ahrens
Erik O. Martz
Original Assignee
Disc Dynamics, 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
Application filed by Disc Dynamics, Inc. filed Critical Disc Dynamics, Inc.
Publication of WO2010027622A1 publication Critical patent/WO2010027622A1/en

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    • AHUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7094Solid vertebral fillers; devices for inserting such fillers
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    • 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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
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    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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    • A61B17/7095Solid vertebral fillers; devices for inserting such fillers the filler comprising unlinked macroscopic particles
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    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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    • 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
    • A61F2230/0091Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • 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
    • 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
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • 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
    • A61F2310/00179Ceramics or ceramic-like structures

Definitions

  • the present invention relates to various retention structures for forming an intervertebral prosthesis in situ, and in particular to a retention structure for an intervertebral disc space adapted to engage with an in situ curable biomaterial and a method of delivering the curable biomaterial.
  • intervertebral discs which are located between adjacent vertebrae in the spine, provide structural support for the spine as well as the distribution of forces exerted on the spinal column.
  • An intervertebral disc consists of three major components: cartilage endplates, nucleus pulposus, and annulus fibrosus.
  • the central portion the nucleus pulposus or nucleus
  • the nucleus pulposus has high proteoglycan content and contains a significant amount of Type II collagen and chondrocytes.
  • Surrounding the nucleus is the annulus fibrosus, which has a more rigid consistency and contains an organized fibrous network of about 40% Type I collagen, about 60% Type II collagen, and fibroblasts.
  • the annular portion serves to provide peripheral mechanical support to the disc, afford torsional resistance, and contain the softer nucleus while resisting its hydrostatic pressure.
  • Intervertebral discs are susceptible to disease, injury, and deterioration during the aging process.
  • Disc herniation occurs when the nucleus begins to extrude through an opening in the annulus, often to the extent that the herniated material impinges on nerve roots in the spine or spinal cord.
  • the posterior and posterolateral portions of the annulus are most susceptible to attenuation or herniation, and therefore, are more vulnerable to hydrostatic pressures exerted by vertical compressive forces on the intervertebral disc.
  • Various injuries and deterioration of the intervertebral disc and annulus fibrosus are discussed by Osti et al., Annular Tears and Disc Degeneration in the Lumbar Spine, J.
  • 5,047,055 (Bao et al.) teaches a swellable hydrogel prosthetic nucleus.
  • Other devices known in the art such as intervertebral spacers, use wedges between vertebrae to reduce the pressure exerted on the disc by the spine.
  • Intervertebral disc implants for spinal fusion are known in the art as well, such as disclosed in U.S. Patent Nos. 5,425,772 (Brantigan) and 4,834,757 (Brantigan).
  • Suizer's BAK® Interbody Fusion System involves the use of hollow, threaded cylinders that are implanted between two or more vertebrae. The implants are packed with bone graft to facilitate the growth of vertebral bone. Fusion is achieved when adjoining vertebrae grow together through and around the implants, resulting in stabilization.
  • Prosthetic implants formed of biomaterials that can be delivered and cured in situ, using minimally invasive techniques to form a prosthetic nucleus within an intervertebral disc have been described in U.S. Patent Nos. 5,556,429 (Felt) and 5,888,220 (Felt et al.), and U.S. Patent Publication No. US 2003/0195628 (Felt et al.), the disclosures of which are incorporated herein by reference.
  • the disclosed method includes, for instance, the steps of inserting a collapsed mold apparatus (which in a preferred embodiment is described as a "mold") through an opening within the annulus, and filling the mold to the point that the mold material expands with a flowable biomaterial that is adapted to cure in situ and provide a permanent disc replacement.
  • a collapsed mold apparatus which in a preferred embodiment is described as a "mold”
  • Related methods are disclosed in U.S. Patent No. 6,224,630 (Bao et al.), entitled “Implantable Tissue Repair Device” and U.S. Patent No. 6,079,868 (Rydell), entitled “Static Mixer", the disclosures of which are incorporated herein by reference.
  • Figure 1 illustrates an exemplary prior art catheter 1 1 with mold or balloon 13 located on the distal end.
  • biomaterial 23 is delivered to the mold 13 through the catheter 11.
  • Secondary tube 11 ' evacuates air from the mold 13 before, during and/or after the biomaterial 23 is delivered.
  • the secondary tube 11 ' can either be inside or outside the catheter 11.
  • the present invention relates to an intervertebral prosthesis and method for forming an intervertebral prosthesis located in an intervertebral disc space.
  • a retention structure and an in situ curable biomaterial combine in situ to form the intervertebral prosthesis.
  • the present method and prosthesis can be used, for example, to implant a prosthetic disc nucleus using minimally invasive techniques that leave the surrounding disc tissue substantially intact or to implant a prosthetic total disc.
  • the phrase intervertebral disc prosthesis is used generically to refer to both of these variations.
  • One embodiment is directed to an assembly for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient.
  • At least one retention structure is located in the intervertebral disc space.
  • a distal end of at least a first lumen is located proximate the at least one retention structure.
  • One or more in situ curable biomaterials are delivered to the intervertebral disc space through the first lumen and into engagement with the retention structure.
  • the curable biomaterial preferably adheres to and is at least partially captured by the retention structure. Consequently, the retention structure serves to retain at least a portion of the biomaterial in the intervertebral disc space.
  • the at least partially cured biomaterial and the at least one retention structure cooperate to comprise the prosthesis.
  • the retention structure includes a band with openings opposite end plates of the adjacent vertebrae.
  • the band is preferably oriented perpendicular relative to an axis of the spine to restrain the biomaterial from creating excessive pressure on the annular walls.
  • the retention structure includes one or more collapsed retention structures adapted to expand when located in the intervertebral disc space. In another embodiment, the retention structure expands during delivery of the curable biomaterial.
  • the retention structure can be a discrete member or a plurality of retention structures adapted to be delivered sequentially through a lumen into the intervertebral disc space.
  • the retention structure can be expandable and/or reorientable.
  • the retention structure is adapted to be assembled within the intervertebral disc space.
  • the retention structure optionally includes a plurality of interlocking members that are assembled in situ.
  • the retention structure comprises a plurality of magnetic members that are assembled in situ.
  • the retention structure can be one or more inflatable members, woven or non-woven mesh, or coiled or kinked members.
  • the retention structure preferably includes a plurality of tension and compression members.
  • the retention structure may include one or more of individual strands, coils, woven or non-woven webs, open cell foams, closed cell foams, combination of open and closed cell foams, scaffolds, cotton-ball fiber matrix, or a generally honeycomb retention structure.
  • the retention structure includes a plurality of interconnected cavities. Fluid flow devices interposed between at least some of the interconnected cavities selectively control the flow of biomaterial into at least some of the cavities.
  • the retention structure includes a plurality of discrete cavities at least a portion of which are at least partially filled with biomaterial.
  • the at least partially cured biomaterial preferably substantially encapsulates the retention structure.
  • the retention structure when in the intervertebral disc space preferably comprises at least one cross-sectional area greater than a diameter of an opening in the lumen.
  • the distal end of the lumen is optionally coupled to at least one retention structure.
  • the lumen is optionally releasably attached to the retention structure.
  • at least one valve is provided to retain the biomaterial in the cavity after the lumen is removed.
  • One or more of the retention structure or the biomaterial optionally include a bioactive agent.
  • at least a portion of an anatomical annulus contains the retention structure and the curable biomaterial.
  • a mold optionally contains the retention structure and the curable biomaterial. The mold can be a balloon or a porous envelope.
  • the present invention is also directed to a method for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient.
  • the method includes locating at least one retention structure in the intervertebral disc space.
  • a distal end of at least a first lumen is located proximate at least one retention structure.
  • One or more flowable, curable biomaterials is delivered into the intervertebral disc space through the first lumen.
  • the flowable biomaterial engages with the retention structure located in the intervertebral disc space so that the retention structure retains at least a portion of the biomaterial in the intervertebral disc space.
  • the at least partially cured biomaterial and the retention structures cooperating to comprise the prosthesis.
  • Minimally invasive refers to a surgical mechanism, such as microsurgical, percutaneous, or endoscopic or arthroscopic surgical mechanism.
  • the entire procedure is minimally invasive, for instance, through minimal incisions in the epidermis (e.g., incisions of less than about 6 centimeters, and more preferably less than 4 centimeters, and preferably less than about 2 centimeters).
  • the procedure is minimally invasive only with respect to the annular wall and/or pertinent musculature, or bony structure.
  • Such surgical mechanism are typically accomplished by the use of visualization such as fiber optic or microscopic visualization, and provide a postoperative recovery time that is substantially less than the recovery time that accompanies the corresponding open surgical approach.
  • Retention structure generally refers to the portion or portions of the present invention used to receive, constrain, shape and/or retain a flowable biomaterial in the intervertebral disc space during curing the biomaterial in situ.
  • a retention structure may include or rely upon natural tissues (such as the annular shell of an intervertebral disc or the end plates of the adjacent vertebrae) for at least a portion of its conformation or function.
  • the retention structure may form a fully enclosed cavity or chamber or may rely on natural tissue for a portion thereof.
  • the retention structure is responsible, at least in part, for determining the position and final dimensions of the cured prosthetic implant.
  • its dimensions and other physical characteristics can be predetermined to provide an optimal combination of such properties as the ability to be delivered to a site using minimally invasive means, filled with biomaterial, control moisture contact, and optionally, then remain in place as or at the interface between cured biomaterial and natural tissue.
  • the retention structure can itself become integral to the body of the cured biomaterial.
  • the retention structure may be used in combination with a mold.
  • Mold generally refers to a flexible member including at least one cavity for the receipt of biomaterial and at least one lumen to that cavity. Multiple molds, either discrete or connected, may be used in some embodiments. Some or all of the material used to form the mold will generally be retained in situ, in combination with the cured biomaterial, while some or the entire lumen will generally be removed upon completion of the procedure.
  • the mold and/or lumens can be biodegradable or bioresorbable. Examples of biodegradable materials can be found in U.S. Publication Nos. 2005-0197422; 2005-0238683; and 2006-0051394, the disclosures of which are hereby incorporated by reference.
  • the mold can be an impermeable, semi-permeable, or permeable membrane.
  • the mold is a highly permeable membrane, such as for example a woven or non-woven mesh or other durable, loosely woven fabrics.
  • the mold and/or biomaterial can include or be infused with drugs, pH regulating agents, pain inhibitors, and/or growth stimulants.
  • Biomaterial generally refers to a material that is capable of being introduced to the site of a joint and cured to provide desired physical-chemical properties in vivo.
  • the term will refer to a material that is capable of being introduced to a site within the body using minimally invasive means, and cured or otherwise modified in order to cause it to be retained in a desired position and configuration.
  • biomaterials are flowable in their uncured form, meaning they are of sufficient viscosity to allow their delivery through a lumen of on the order of about 1 mm to about 10 mm inner diameter, and preferably of about 2 mm to about 6 mm inner diameter.
  • Such biomaterials are also curable, meaning that they can be cured or otherwise modified, in situ, at the tissue site, in order to undergo a phase or chemical change sufficient to retain a desired position and configuration.
  • the method and apparatus of the present invention uses one or more discrete access points or annulotomies into the intervertebral disc space, and/or through the adjacent vertebrae.
  • the annulotomies facilitate performance of the nuclectomy, imaging or visualization of the procedure, delivery of the retention structure and biomaterial through one or more lumens, drawing a vacuum on a mold before, during and/or after delivery of the biomaterial, and securing the prosthesis in the intervertebral disc space during and after delivery of the biomaterial.
  • Figure 1 is an exemplary prior art catheter and mold.
  • Figure 2 is a schematic illustration of various entry paths for use in accordance with the present invention.
  • Figures 3 A and 3 B are cross-sectional views of an annulus containing a mold assembly with one or more valves in accordance with the present invention.
  • Figures 3 C and 3D are side sectional views of a mold assembly including a connector assembly in accordance with the present invention.
  • Figure 3 E is a cross-sectional view of the mold assembly of Figures 3 C and 3D implanted in a patient.
  • Figures 4A and 4B are cross-sectional views of an annulus containing a mold assembly with an alternate valves in accordance with the present invention.
  • Figures 5A and 5B are cross-sectional views of an annulus containing a mold assembly with alternate valves in accordance with the present invention.
  • Figures 6A and 6B are cross-sectional views of an annulus containing a retention structure in the form of bands in accordance with the present invention.
  • Figures 6C and 6D are cross-sectional views of an annulus containing a mold assembly comprising a retention structure in accordance with the present invention.
  • Figures 7A and 7B are cross-sectional views of an annulus containing a prosthesis with an expandable retention structure in accordance with the present invention.
  • Figure 8 is a cross-sectional view of an annulus containing a prosthesis with an expandable retention structure in a mold in accordance with the present invention.
  • Figure 9 is a cross-sectional view of an annulus containing a prosthesis with an alternate expandable retention structure in accordance with the present invention.
  • Figures 1OA and 1OB are cross-sectional views of an annulus containing a prosthesis with a plurality of helical coils assembled into a retention structure in accordance with the present invention.
  • Figures 11 A and 11 B are cross-sectional views of an annulus containing a prosthesis with a plurality of spherical retention structures in accordance with the present invention.
  • Figure 12 is a cross-sectional view of an annulus containing a prosthesis with an assembled retention structure in accordance with the present invention.
  • Figure 13 is a cross-sectional view of an annulus containing a prosthesis with an alternate assembled retention structure in accordance with the present invention.
  • Figure 14 is a cross-sectional view of an annulus containing a prosthesis with a fibrous retention structure in accordance with the present invention.
  • Figure 15 A is a cross-sectional view of an annulus containing a prosthesis with an expandable honeycomb retention structure in accordance with the present invention.
  • Figures 15B and 15C are side and top sectional views of an annulus containing a prosthesis with an alternate expandable honeycomb structure in accordance with the present invention.
  • Figure 16 is a cross-sectional view of an annulus containing a mold assembly with multiple molds and a pressure activated retention structure in accordance with the present invention.
  • Figures 17A and 17B are cross-sectional views of an annulus containing variations of the mold assembly of Figure 16.
  • Figures 18A and 18B are cross-sectional views of an annulus containing a mold assembly with multiple molds and an alternate pressure activated retention structure in accordance with the present invention.
  • Figure 18C is a cross-sectional view of the mold assembly of Figures 18A and
  • Figures 19 A and 19B are cross-sectional views of an annulus containing a mold assembly with patterned radiopaque markers in accordance with the present invention.
  • Figures 2OA and 2OB are cross-sectional views of an annulus containing a mold assembly with an alternate patterned radiopaque markers in accordance with the present invention.
  • Figure 21 is a cross-sectional view of an annulus containing a pair of nested molds in accordance with the present invention.
  • Figure 22 is a perspective view of the present mold assembly separating adjacent transverse processes in accordance with the present invention.
  • Figure 23 is a perspective view of the present mold assembly separating adjacent spinous processes in accordance with the present invention.
  • FIG. 2 is a cross-sectional view of a human body 20 showing various access paths 22 through 38 to the intervertebral disc 40 for performing the method of the present invention.
  • the posterior paths 22, 24 extend either between superior and inferior transverse processes 42, or between the laminae (interlaminar path) on either side of the spinal cord 44.
  • the posterolateral paths 26, 28 are also on opposite sides of the spinal cord 44 but at an angle of about 35-45 degrees relative to horizontal relative to the posterior paths 22, 24.
  • the lateral paths 30, 32 extend through the side of the body.
  • the anterior path 38 and anterolateral path 34 extend past the aorta iliac artery 46, while the anterolateral path 36 is offset from the inferior vena cava, iliac veins 48.
  • the aorta and vena cava split at the L4 vertebral body.
  • the approach is typically a midline anterior approach.
  • the approach may be either midline anterior or anterolateral, depending on the patient anatomy and how easy it is to retract the vessels.
  • the anterior approach is deemed a midline approach and the anterolateral approach is deemed an angled approach offset from the midline anterior approach.
  • the present method and apparatus use one or more of the access paths 22 through 38. While certain of the access paths 22 through 38 may be preferred depending on a number of factors, such as the nature of the procedure, any of the access paths can be used with the present invention.
  • delivery catheter instruments are positioned along two or more of the access paths 22 through 38 to facilitate preparation of the intervertebral disc 40.
  • Preparation includes, for example, formation of two or more annulotomies through the annular wall, removal of some or all of the nucleus pulposus to form a nuclear cavity, imaging of the annulus and/or the nuclear cavity, and positioning of the present multi-lumen mold in the nuclear cavity.
  • the present multi-lumen mold is positioned in the intervertebral disc 40 without use of delivery catheters.
  • Figure 3A illustrates one embodiment of a mold assembly 50 in accordance with the present invention.
  • the mold assembly 50 includes lumen 52 fluidly coupled to mold 54.
  • valve 56 is provided at the interface between the lumen 52 and the mold 54.
  • valve 58 is optionally located at a separate location on the mold 54.
  • the method of using the present mold assembly 50 involves forming an annulotomy 60 at a location in the annulus 62.
  • the nucleus pulposus 64 located in the disc space 66 is preferably substantially removed to create a nuclear cavity 68. As illustrated in
  • nucleus pulposus 64 may remain in the nuclear cavity 68 after the nuclectomy.
  • the mold assembly 50 is then inserted through the annulotomy 60 so that the mold 54 is positioned in the nuclear cavity 68.
  • biomaterial 70 is delivered through the lumen 52 into the mold 54. As the biomaterial 70 progresses through the mold 54, at least a portion of the air located in the mold 54 is preferably pushed out through the valve 58.
  • the valves 56 and 58 are preferably check valves that are forced into the closed position by the pressure of the biomaterial 70.
  • the lumen 52 is detached from the mold 54 removed from the annulotomy 60.
  • the valve 56 permits the lumen 52 to be separated and removed before the biomaterial 70 has cured.
  • one or more of the mold 54, the valves 56, 58, and/or the lumens 52 have radiopaque properties that facilitate imaging of the prosthesis 72 being formed.
  • the lumen 52 is releasably attached to the valve 56 to facilitate removal.
  • FIGS 3C and 3D are assembly views of a mold assembly 500 with a connection assembly 502 recessed in the mold 504 in accordance with the present invention. Open end 506 of the mold 504 is inserted into sleeve 508. The connector assembly 502 is then coupled to the sleeve 508. The open end 506 is secured between the sleeve 508 and connector assembly 502. In the illustrated embodiment, distal end of the connector assembly 502 includes a mechanical interface 510 that mechanically couples with the sleeve 508. The connector assembly 502 can be coupled to the open end 506 of the mold 504 and the sleeve 508 using a variety of techniques, such as adhesives, mechanical interlocks, fasteners, and the like.
  • the exposed end 512 of the connector assembly 502 preferably includes a mechanical interlock 514, such as for example internal threads, that couple with a corresponding interlock 516, such as external threads, on the lumen 518.
  • a mechanical interlock 514 such as for example internal threads
  • a corresponding interlock 516 such as external threads
  • the biomaterial 70 is retained in the mold by valve 520 preferably located in the connector assembly 502.
  • the connector assembly 502 and/or the valve 520 are substantially flush with the outer surface of the mold 504.
  • the connector assembly 502 may protrude above the outer surface of the mold 504.
  • the lumen 518 is preferably removed from the mold assembly 500 before the biomaterial 70 is cured.
  • FIG. 4A illustrates an alternate mold assembly 80 in accordance with the present invention.
  • Mold 82 includes a plurality of openings 84.
  • the openings 84 can be any shape and a variety of sizes.
  • Internal flaps 86 are located over the openings 84.
  • biomaterial 70 is delivered through lumen 88 to the mold 82. Pressure from the biomaterial 70 presses the flaps 86 against the openings 84, substantially sealing the biomaterial 70 within the mold 82.
  • the flaps 86 permit any air or biomaterial in the mold 82 to be pushed out through the openings 84 during delivery of the biomaterial 70. In another embodiment, the flaps 86 to not completely seal the openings 84 until the mold 82 is substantially inflated and pressing against inner surface 92 of the annulus 62. [0068]
  • the flaps 86 can be constructed from the same or different material than the mold 82. In one embodiment, the flaps 86 are constructed from a radiopaque material that is easily visible using various imaging technologies. Prior to the delivery of the biomaterial 70, such as illustrated in Figure 4A, the spacing between the flaps 86 indicates that the mold 82 is not inflated.
  • the spacing between the flaps 86 provides an indication of the shape and position of the intervertebral prosthesis 90 relative to the annulus 62.
  • FIG. 5A illustrates an alternate mold assembly 100 in accordance with the present invention.
  • Mold 102 includes a plurality of openings 104 with corresponding external flaps or valves 106.
  • delivery of the biomaterial 70 causes the mold 102 to inflate.
  • the flaps 106 are pressed against the openings 104 by interior surface 108 of the nuclear cavity 68.
  • portion 110 of the biomaterial 70 forms a raised structure 1 12 over some or all of the openings 104. These raised structures serve to anchor the resulting prosthesis 1 14 in the nuclear cavity 68.
  • portion 1 16 of the biomaterial 70 optionally escapes from the mold 102 prior to the flaps 106 being pressed against the openings 104.
  • the portion 1 16 of the biomaterial 70 serves to adhere the prosthesis 114 to the inner surface 108 of the annulus 62.
  • the flaps 106 may include radiopaque properties.
  • FIGS 6 A and 6B illustrate a prosthesis 136 including one or more retention structures 124, 126.
  • retention structure 124 is positioned horizontally between adjacent vertebrae 128, 130.
  • Retention structure 126 is oriented perpendicular to the retention structure.
  • Lumen 120 is preferably engaged with one or both of the retention structures 124, 126.
  • the retention structure preferably limits the amount of pressure the resulting prosthesis 136 places on the annular walls 62.
  • a compressive force placed on the prosthesis 136 by the end plates 132, 134 is directed back towards the end plates, rather than horizontally into the annular wall 62.
  • the retention structure preferably limits inflation of the mold 122 in the vertical direction.
  • the retention structure can optionally be used to set a maximum disc height or separation between the adjacent vertebrae 128, 130 when the mold 122 is fully inflated.
  • the retention structure 124, 126 are preferably radiopaque. As with the flaps 86, 106 of Figures 4 and 5, the retention structure 124, 126 provide an indication of the shape and position of the prosthesis 136 in the intervertebral disc space 138. As the biomaterial is delivered, the retention structures 124, 126 are deployed and positioned in accordance with the requirements of the prosthesis 136. A series of images can be taken of the intervertebral disc space 138 to map the progress of the prosthesis formation. Because the size and width of the retention structure 124, 126 are known prior to the procedure, the resulting images provide an accurate picture of the position of the prosthesis 136 relative to the vertebrae 128, 130.
  • the retention structures 124, 126 are used in combination with mold 122. In an alternate embodiment, one or both of the retention structures 124, 126 can be located at the interior of the mold 122. The retention structures 124, 126 can optionally be attached to the mold 122.
  • FIGs 6C and 6D illustrate a retention structure 142 in accordance with the present invention.
  • the retention structure 142 is preferably positioned horizontally between adjacent vertebrae 128, 130.
  • the retention structure 142 also serves as a mold for retaining at least a portion of the biomaterial 70.
  • the annulus wall 62 may also act to retain the biomaterial 70 in the intervertebral disc space.
  • the retention structure 142 preferably extends to the endplates 132, 134 so that the biomaterial 70 is substantially retained in center region 144 formed by the retention structure 142.
  • the biomaterial 70 extends above and below the retention structure 142 to engage with the endplates 132, 134.
  • the retention structure 142 is open at the top and bottom. In some embodiments, the biomaterial 70 may flow around the outside perimeter of the retention structure 142.
  • FIGs 7 A and 7B illustrate an alternate prosthesis 158 in accordance with the present invention.
  • Retention structure 154 configured in a compressed state is delivered into the nuclear cavity 68 of the annulus 62 through delivery lumen 156.
  • the retention structure 154 As best illustrated in Figure 7B, once the retention structure 154 is released from the delivery lumen 156, it assumes its original expanded shape within the nuclear cavity 68.
  • the biomaterial 70 is delivered to the nuclear cavity 68, where it flows into and around the retention structure 154.
  • the retention structure 154 serves to retain at least a portion of the biomaterial in the nuclear cavity 68 by surface tension, adhesion, mechanical capture, friction, viscosity, and a variety of other mechanisms.
  • the retention structure 154 is deployed by the pressure of the biomaterial 70 being delivered into the nuclear cavity 68.
  • the retention structure 154 is a mesh woven to form a generally tubular structure.
  • the mesh 154 can be constructed from a variety of metal, polymeric, biologic, and composite materials suitable for implantation in the human body. In one embodiment, the mesh operates primarily as a tension member within the prosthesis 158. Alternatively, the retention structure 154 is configured to act as both a tension and compression member within the prosthesis 158.
  • the retention structure 154 are constructed from a radiopaque material.
  • the radiopaque elements of the retention structure 154 provide a grid or measuring device that is readily visible using conventional imaging techniques.
  • the retention structure 154 thus provides a way to determine the shape, volume, dimensions, and position of the prosthesis 158 in the annular cavity 68.
  • Figure 8 illustrates an alternate prosthesis 160 with an internal retention structure 162 having a shape generally corresponding to the nuclear cavity 68. As illustrated in Figure 7, the retention structure 162 is compressed within the delivery lumen 156 (see Figure 7A) and delivered into mold 164 located in the nuclear cavity 68. Once in the expanded configuration illustrated in Figure 8, the retention structure 162 can operate as a tension and/or compression member within the prosthesis 160.
  • FIG 9 illustrates an alternate prosthesis 170 in accordance with the present invention.
  • Retention structure 172 is again positioned in the nuclear cavity 68 in a compressed configuration through a delivery lumen 156 (see Figure 7A).
  • the retention structure 172 is preferably constructed of a shape memory alloy (SMA), such as the nickel- titanium alloy Nitinol or of an elastic memory polymer that assumes a predetermined shape once released from the delivery lumen 156 or once a certain temperature is reached, such as for example the heat of the body.
  • the retention structure 172 has radiopaque properties which can be used to facilitate imaging of the prosthesis 170.
  • the retention structure 172 is a mold configured with a coil shape.
  • FIGS 1OA and 1OB illustrate an alternate prosthesis 188 in accordance with the present invention.
  • a plurality of discrete helical retaining structures 182 are delivered through a delivery lumen 184 into the annular cavity 68.
  • the helical retaining structures 182 intertwine and become entangled within the annular cavity 68.
  • the helical retaining structures 182 are rotated during insertion to facilitate engagement with the retaining structures 182 already in the annular cavity 68.
  • these retaining structures 182 can be kinked strands, which when compressed have a generally longitudinal orientation to provide easy delivery through the lumen 184. Once inside the annular cavity 68, the retaining structures 182 are permitted to expand or reorient.
  • the cross-sectional area of the retaining structures 182 in the expanded or reoriented state is preferably greater than the diameter of the lumen 184, so as to prevent ejection during delivery of the biomaterial 70.
  • the plurality of retaining structures 182 are preferably discrete structures that act randomly and can be positioned independently.
  • the discrete retaining structures 182 of the present invention can be delivered sequentially and interlocked or interengaged in situ. Alternatively, groups of the retaining structures 182 can be delivered together.
  • the relative position of the retaining structures 182 is set.
  • the retaining structures 182 can act as spring members to provide additional resistance to compression and as tension members within the prosthesis 188.
  • Some or all of the helical retaining structures 182 preferably have radiopaque properties to facilitate imaging of the prosthesis 188.
  • FIGS 1 IA and 1 IB illustrate an alternate prosthesis 200 in accordance with the present invention.
  • a plurality of retaining structures 204 are delivered into the nuclear cavity 68.
  • Biomaterial 70 is then delivered to the nuclear cavity 68.
  • the retention structures 204 assist in holding the biomaterial 70 in place.
  • the retention structures 204 typically arrange themselves randomly within the intervertebral disc space 202.
  • the retention structures 204 are a plurality of spherical members 206.
  • the spherical members 206 flow and shift relative to each other within the intervertebral disc space 202.
  • the spherical members 206 are constructed from metal, ceramic, and/or polymeric materials.
  • the spherical members 206 can also be a multi-layered structure, such as for example, a metal core with a polymeric outer layer.
  • the spherical members 206 are hollow shells with openings into which the biomaterial 70 can flow.
  • the biomaterial 70 fills the hollow interior of the spherical members 206 and bonds adjacent spherical members 206 to each other.
  • the spherical members 206 have magnetic properties so they clump together within the intervertebral disc space 202 before the biomaterial 70 is delivered. Some or all of the spherical members 206 optionally have radiopaque properties.
  • Figure 12 is a side sectional view of an intervertebral disc space 138 containing prosthesis 210 in accordance with the present invention.
  • a plurality of polyhedron retention structures 212 are delivered into the intervertebral disc space 138 through lumen 216.
  • the retention structure can be pyramidal, tetrahedrons, and the like.
  • the pyramidal retention structures 212 have magnetic properties causing them to bind to each other within the intervertebral disc space 138.
  • the pyramidal retention structures 212 include a plurality of holes or cavities into which the biomaterial 70 flows, securing the retention structures 212 relative to each other and relative to the prosthesis 210.
  • Figure 13 is a side sectional view of an intervertebral disc space 138 with prosthesis 224 having coiled or loop shaped retention structures 220 in accordance with the present invention.
  • the retention structures 220 can be compressed for delivery through the lumen 222, and allowed to expand once inside the nuclear cavity 68.
  • Biomaterial 70 is then injected to secure the relative position of the retention structures 220 within the prosthesis 224.
  • the retention structures 220 are preferably constructed from a spring metal that helps maintain the separation between the adjacent vertebrae 128, 130. In one embodiment, the retention structures 220 are resilient and flex when loaded. In an alternate embodiment, the retention structures 220 are substantially rigid in at least one direction, while being compliant in another direction to permit insertion through the lumen 222. The retention structures 220 optionally define a minimum separation between the adjacent vertebrae 128, 130. The retention structures 220 can operate as tension and/or compression members. [0095] Figure 14 is a side sectional view of an alternate prosthesis 258 in accordance with the present invention. A plurality of reinforcing fibers 252 are delivered into the intervertebral disc space 254 through lumen 256.
  • the biomaterial 70 is then delivered and secures the relative position of the reinforcing fibers 252 within the intervertebral disc space 138.
  • the reinforcing fibers 252 can be in the form of individual strands, coils, woven or non- woven webs, open cell foams, closed cell foams, combination of open and closed cell foams, scaffolds, cotton-ball fiber matrix, or a variety of other structures.
  • the reinforcing fibers 252 can be constructed from metal, ceramic, polymeric materials, or composites thereof.
  • the reinforcing fibers 252 can operate as tension and/or compression members within prosthesis
  • FIG 15 A is a side sectional view of an alternate prosthesis 278 in accordance with the present invention.
  • a three-dimensional honeycomb structure 272 is compressed and delivered into the intervertebral disc space 274 through the lumen 276. Once in the expanded configuration, illustrated in Figure 15 A, the biomaterial 70 is delivered, fixing the honeycomb structure 272 in the illustrated configuration. In another embodiment, the delivery of the biomaterial expands or inflates the honeycomb structure 272.
  • the biomaterial 70 flows around and into the honeycomb structure 272 providing a highly resilient prosthesis 278.
  • the honeycomb structure 272 still retains its capacity to flex along with the biomaterial 70 when compressed by the adjacent vertebrae 128, 130.
  • the honeycomb structure 272 can be constructed from a plurality of interconnected tension and/or compression members.
  • the honeycomb structure is an open cell foam.
  • the honeycomb structure 272 has fluid flow devices, such as for example pores, holes of varying diameter or valves, interposed between at least some of the interconnected cavities 280.
  • the fluid flow devices selectively controlling the flow of biomaterial 70 into at least some of the cavities 280 or filling the cavities 280 differentially, thus combining the different mechanical properties of the honeycomb structure 272 with the biomaterial 70 in an adaptable manner.
  • the generally honeycomb structure 272 can optionally be combined with open or closed cell foam.
  • FIGS 15B and 15C are side and top sectional views of a prosthesis 282 with a plurality of three-dimensional honeycomb structures 284A, 284B (referred to collectively as
  • honeycomb structures 284 are constructed so that the inflow of biomaterial 70 can be selectively directed to certain cavities
  • honeycomb structures 284A, 284B can optionally be used.
  • holes interconnecting adjacent cavities 286 can be selectively opened or closed before the honeycomb structures 284 are inserted into the patient.
  • a plurality of lumens 288A, 288B, 288C, ... (referred to collectively as
  • Biomaterial 70 into the honeycomb structures 284 can be used to create a variety of predetermined internal shapes. Using a plurality of lumens 288 permits different biomaterials 7OA, 7OB, 7OC, ... to be delivered to different cavities 286 within the honeycomb structure 284.
  • the biomaterials 7OA, 7OB, 70C, ... can be selected based on a variety of properties, such as mechanical or biological properties, biodegradability, bioabsorbability, ability to delivery bioactive agents.
  • bioactive agent refers to cytokines and preparations with cytokines, microorganisms, plasmids, cultures of microorganisms, DNA-sequences, clone vectors, monoclonal and polyclonal antibodies, drugs, pH regulators, cells, enzymes, purified recombinant and natural proteins, growth factors, and the like.
  • Figure 16 illustrates an alternate mold assembly 300 in accordance with the present invention.
  • two annulotomies 6OA, 6OB are formed in the annulus 62.
  • the mold assembly 300 is threaded through one of the annulotomies so that the lumens 302, 304 each protrude from annulotomies 6OA, 6OB, respectively.
  • Lumen 302 is fluidly coupled to mold 306 while lumen 304 is fluidly coupled with mold 308.
  • Retention structure 310 is attached to molds 306, 308 at the locations 312, 314, respectively.
  • Figure 17A is a side sectional view of the mold assembly 300 of Figure 16 implanted between adjacent vertebrae 128, 130.
  • Biomaterial 70 is delivered to the molds 306, 308, which applies opposing compressive forces 316 on the retention structure 310.
  • the retention structure 310 is a coil, loop, or bend (arc) of resilient material, such as a memory metal, spring metal, and the like.
  • the resulting prosthesis 312 includes a pair of molds 306, 308 containing a cured biomaterial 70 holding the retention structure 310 against adjacent end plates 132, 136 of the vertebrae 128, 130 respectively.
  • the retention structure can serve to resist compression of the prosthesis 312 or to establish a minimum separation between the adjacent end plates 132, 134.
  • FIG 17B is an alternate embodiment of the mold assembly 300 of Figure 16.
  • retention structure 310 includes a series of fold lines or hinges 318. Expansion of the molds 306, 308 with biomaterial 70 generates forces 316 that converts the generally flat retention structure 310 (see Figure 16) into the shaped retention structure 322 illustrated in Figure 17B. Alternatively, the hinge 318 could be facing the molds 306, 308 rather than the endplates. In the embodiments of Figures 17A and 17B, delivery of the biomaterial 70 deploys the retention structure 310 to an expanded configuration.
  • Figures 18A and 18B illustrate an alternate mold assembly 350 in accordance with the present invention.
  • Lumens 352, 354 extend into the annulus 62 through different annulotomies 6OA, 6OB. Lumen 352 is fluidly coupled with mold 356 and lumen 354 is fluidly coupled with mold 358. Reinforcing mesh structure 364 is connected to the molds 356, 358 at locations 360, 362, respectively. As illustrated in Figure 18B, biomaterial 70 is delivered to the molds 356, 358 causing the retention structure 364 to be compressed and/or stretched within the nuclear cavity 68.
  • additional biomaterial 70 can optionally be delivered into the nuclear cavity 68 proximate the retention structure 364.
  • the same or a different biomaterial 7OA flows around and into the retention structure 364.
  • the biomaterial 7OA bonds the retention structure 364 to the annulus 62.
  • the resulting prosthesis 366 has three distinct regions of resiliency. The areas of varying resiliency can be tailored for implants that would be implanted via different surgical approaches, as well as various disease states.
  • the retention structure 364 optionally includes radiopaque properties.
  • a series of images taken during delivery of the biomaterial 70 illustrates the expansion and position of the prosthesis 366 in the nuclear cavity 68.
  • FIG 18C is an alternate configuration of the mold assembly 350 for use with mono-portal applications in accordance with the present invention.
  • Lumens 352, 354 extend into the annulus 62 through a single annulotomy 60.
  • Lumen 352 is fluidly coupled with mold 356 and lumen 354 is fluidly coupled with mold 358.
  • Reinforcing mesh structure 364 is connected to the molds 356, 358 at locations 360, 362, respectively.
  • delivery of the biomaterial 70 causing the retention structure 364 to be compressed and/or stretched within the nuclear cavity 68.
  • Additional biomaterial 7OA can optionally be delivered into the nuclear cavity 68 proximate the retention structure 364.
  • FIGS 19A and 19B are side sectional views of mold assembly 400 in accordance with the present invention.
  • the mold 402 includes a plurality of radiopaque markers 404.
  • the radiopaque markers 404 are arranged in a predetermined pattern around the perimeter of the mold 402.
  • the spacing 406 between the adjacent radiopaque markers 404 increases.
  • a series of images can be generated showing the change in the spacing between the radiopaque markers 404. Because the spacing between the radiopaque markers 404 is known prior to delivery of the biomaterial, it is possible to calculate the shape and position of the prosthesis 408 illustrated in Figure 19B using conventional imaging procedures.
  • FIGs 2OA and 2OB illustrate an alternate mold assembly 420 in accordance with the present invention.
  • Mold 422 includes a plurality of radiopaque strips 424 located strategically around its perimeter. When the mold 422 is inflated with biomaterial, the spacing 426 between the radiopaque strips 424 changes, providing an easily imageable indication of the shape and position of the prosthesis 428 in the intervertebral disc space 138.
  • Figure 21 illustrates an alternate mold assembly 450 in accordance with the present invention.
  • Inner mold 452 is fluidly coupled to lumen 454.
  • Outer mold 456 is fluidly coupled to lumen 458. Biomaterial is delivered through the lumen 454 into the inner mold 452.
  • a radiopaque fluid is preferably delivered to the space 460 between the inner mold 452 and the outer mold 456.
  • the radiopaque material 462 located in the space 460 is expelled from the nuclear cavity 68 through the lumen 458.
  • a series of images of the annulus 62 will show the progress of the biomaterial 70 expanding the inner mold 452 within the nuclear cavity 68 and the flow of the radiopaque fluid 462 out of the space 460 through the lumen 458.
  • a biological material or bioactive agent is injected into the space 460 through the delivery lumen 458.
  • the outer mold 456 is sufficiently porous to permit the bioactive agent to be expelled into the annular cavity 68, preferably over a period of time.
  • One of the molds 452, 456 optionally includes radiopaque properties.
  • the mold 456 is preferably biodegradable or bioresorbable with a half life greater than the time required to expel the bioactive agents.
  • one or more retention structures 464 is located in the space 460 between the inner and outer molds 452, 456.
  • the retention structure 464 may be a woven or non-woven mesh impregnated with the bioactive agent.
  • the retention structure 464 and the outer mold 456 are a single structure, such as a reinforcing mesh impregnated with the bioactive agent.
  • the outer mold 456 may be a stent-like structure, preferably coated with one or more bioactive agents.
  • Figures 22 and 23 illustrate use of a mold assembly 550 to maintain the separation between spinous process 552 and/or transverse processes 554 on adjacent vertebrae 556, 558 in according with the present method and apparatus.
  • the mold assembly 550 may be used alone or in combination with an intervertebral mold assembly, such as discussed herein.
  • the mold assembly 550 can also be used to separate the superior articulating process and inferior articulating process, more commonly referred to as the facet joint, on adjacent vertebrae.
  • the mold 560 preferable includes extension 562, 564 that couple or engage with the spinous process or transverse processes 552, 554. Center portion 566 acts as a spacer to maintain the desired separation.
  • the mold assembly has an H-shaped or figure-8 shaped cross section to facilitate coupling with the various facets on the adjacent vertebral bodies. Attachment of the molds 550 or 560 to the spinous or transverse processes may be further facilitated using sutures, cables, ties, rivets, screws, clamps, sleeves, collars, adhesives, or the like. Any of the mold assemblies and retention structures disclosed herein can be used with the mold assembly 550. [0117] Any of the features disclosed herein can be combined with each other and/or with features disclosed in commonly assigned U.S. Patent Application Serial No. 11/268,786, entitled Multi-Lumen Mold for Intervertebral Prosthesis and Method of Using Same, filed November 8, 2005, which is hereby incorporated by reference.
  • any of the molds and/or lumens disclosed herein can optionally be constructed from biodegradable or bioresorbable materials.
  • the lumens disclosed herein can be constructed from a rigid, semi-rigid, or pliable high tensile strength material.
  • the various components of the mold assemblies disclosed herein may be attached using a variety of techniques, such as adhesives, solvent bonding, mechanical deformation, mechanical interlock, or a variety of other techniques.
  • the mold assembly of the present invention is preferably inserted into the nuclear cavity 68 through a catheter, such as illustrated in commonly assigned U.S. Patent Application Serial No. 1 1/268,876 entitled Catheter Holder for Spinal Implants, filed November 8, 2005, which is hereby incorporated by reference.
  • the mold assemblies and methods of the present invention can also be used to repair other joints within the spine such as the facet joints, as well as other joints of the body, including diarthroidal and amphiarthroidal joints.
  • suitable diarthroidal joints include the ginglymus (a hinge joint, as in the interphalangeal joints and the joint between the humerus and the ulna); throchoides (a pivot joint, as in superior radio-ulnar articulation and atlanto-axial joint); condyloid (ovoid head with elliptical cavity, as in the wrist joint); reciprocal reception (saddle joint formed of convex and concave surfaces, as in the carpometacarpal joint of the thumb); enarthrosis (ball and socket joint, as in the hip and shoulder joints) and arthrodia (gliding joint, as in the carpal and tarsal articulations).
  • the present mold apparatus can also be used for a variety of other procedures, including those listed above.
  • the present mold assembly can also be used to modify the interspinous or transverse process space.
  • the mold can operate as a spacer/distractor between the inferior and superior spinous processes, thus creating a local distraction and kyphosis of wanted.
  • the theory behind these implants is that they expand the intervertebral foramen and thereby relieve pressure on the nerve root and spinal cord.
  • the present injectable prosthesis is adapted to the individual anatomy and clinical situation of the patient, without the need for multiple implant sizes.

Abstract

An assembly for the in situ formation of a prosthesis (136) in an intervertebral disc space between adjacent vertebrae of a patient. At least one retention structure (124, 126) is located in the intervertebral disc space. A distal end of at least one lumen (120) is located proximate the at least one retention structure. One or more in situ curable biomaterials (70) are delivered to the intervertebral disc space through the first lumen and into engagement with the retention structure. The retention structure serves to retain at least a portion of the biomaterial in the intervertebral disc space by surface tension, adhesion, mechanical capture, friction, viscosity, and/or a variety, of other mechanisms. The at least partially cured biomaterial and the at least one retention structure cooperate to comprise the prosthesis.

Description

RETENTION STRUCTURE FOR IN SITU FORMATION OF AN INTERVERTEBRAL PROSTHESIS
FIELD OF THE INVENTION
[0001] The present invention relates to various retention structures for forming an intervertebral prosthesis in situ, and in particular to a retention structure for an intervertebral disc space adapted to engage with an in situ curable biomaterial and a method of delivering the curable biomaterial.
BACKGROUND OF THE INVENTION
[0002] The intervertebral discs, which are located between adjacent vertebrae in the spine, provide structural support for the spine as well as the distribution of forces exerted on the spinal column. An intervertebral disc consists of three major components: cartilage endplates, nucleus pulposus, and annulus fibrosus.
[0003] In a healthy disc, the central portion, the nucleus pulposus or nucleus, is relatively soft and gelatinous; being composed of about 70% to about 90% water. The nucleus pulposus has high proteoglycan content and contains a significant amount of Type II collagen and chondrocytes. Surrounding the nucleus is the annulus fibrosus, which has a more rigid consistency and contains an organized fibrous network of about 40% Type I collagen, about 60% Type II collagen, and fibroblasts. The annular portion serves to provide peripheral mechanical support to the disc, afford torsional resistance, and contain the softer nucleus while resisting its hydrostatic pressure.
[0004] Intervertebral discs, however, are susceptible to disease, injury, and deterioration during the aging process. Disc herniation occurs when the nucleus begins to extrude through an opening in the annulus, often to the extent that the herniated material impinges on nerve roots in the spine or spinal cord. The posterior and posterolateral portions of the annulus are most susceptible to attenuation or herniation, and therefore, are more vulnerable to hydrostatic pressures exerted by vertical compressive forces on the intervertebral disc. Various injuries and deterioration of the intervertebral disc and annulus fibrosus are discussed by Osti et al., Annular Tears and Disc Degeneration in the Lumbar Spine, J. Bone and Joint Surgery. 74-B(5), (1982) pp. 678-682; Osti et al., Annulus Tears and Intervertebral Disc Degeneration, Spine, 15(8) (1990) pp. 762-767; Kamblin et al., Development of Degenerative Spondylosis of the Lumbar Spine after Partial Discectomy, Spine, 20(5) (1995) pp. 599-607. [0005] Many treatments for intervertebral disc injury have involved the use of nuclear prostheses or disc spacers. A variety of prosthetic nuclear implants are known in the art. For example, U.S. Patent No. 5,047,055 (Bao et al.) teaches a swellable hydrogel prosthetic nucleus. Other devices known in the art, such as intervertebral spacers, use wedges between vertebrae to reduce the pressure exerted on the disc by the spine. Intervertebral disc implants for spinal fusion are known in the art as well, such as disclosed in U.S. Patent Nos. 5,425,772 (Brantigan) and 4,834,757 (Brantigan).
[0006] Further approaches are directed toward fusion of the adjacent vertebrate, e.g., using a cage in the manner provided by Sulzer. Suizer's BAK® Interbody Fusion System involves the use of hollow, threaded cylinders that are implanted between two or more vertebrae. The implants are packed with bone graft to facilitate the growth of vertebral bone. Fusion is achieved when adjoining vertebrae grow together through and around the implants, resulting in stabilization.
[0007] Apparatuses and/or methods intended for use in disc repair have also been described for instance in French Patent Appl. No. FR 2 639 823 (Garcia) and U.S. Patent No. 6,187,048 (Milner et al.). Both references differ in several significant respects from each other and from the apparatus and method described below.
[0008] Prosthetic implants formed of biomaterials that can be delivered and cured in situ, using minimally invasive techniques to form a prosthetic nucleus within an intervertebral disc have been described in U.S. Patent Nos. 5,556,429 (Felt) and 5,888,220 (Felt et al.), and U.S. Patent Publication No. US 2003/0195628 (Felt et al.), the disclosures of which are incorporated herein by reference. The disclosed method includes, for instance, the steps of inserting a collapsed mold apparatus (which in a preferred embodiment is described as a "mold") through an opening within the annulus, and filling the mold to the point that the mold material expands with a flowable biomaterial that is adapted to cure in situ and provide a permanent disc replacement. Related methods are disclosed in U.S. Patent No. 6,224,630 (Bao et al.), entitled "Implantable Tissue Repair Device" and U.S. Patent No. 6,079,868 (Rydell), entitled "Static Mixer", the disclosures of which are incorporated herein by reference.
[0009] Figure 1 illustrates an exemplary prior art catheter 1 1 with mold or balloon 13 located on the distal end. In the illustrated embodiment, biomaterial 23 is delivered to the mold 13 through the catheter 11. Secondary tube 11 ' evacuates air from the mold 13 before, during and/or after the biomaterial 23 is delivered. The secondary tube 11 ' can either be inside or outside the catheter 11. BRIEF SUMMARY OF THE INVENTION
[0010] The present invention relates to an intervertebral prosthesis and method for forming an intervertebral prosthesis located in an intervertebral disc space. A retention structure and an in situ curable biomaterial combine in situ to form the intervertebral prosthesis. The present method and prosthesis can be used, for example, to implant a prosthetic disc nucleus using minimally invasive techniques that leave the surrounding disc tissue substantially intact or to implant a prosthetic total disc. The phrase intervertebral disc prosthesis is used generically to refer to both of these variations.
[0011] One embodiment is directed to an assembly for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient. At least one retention structure is located in the intervertebral disc space. A distal end of at least a first lumen is located proximate the at least one retention structure. One or more in situ curable biomaterials are delivered to the intervertebral disc space through the first lumen and into engagement with the retention structure. The curable biomaterial preferably adheres to and is at least partially captured by the retention structure. Consequently, the retention structure serves to retain at least a portion of the biomaterial in the intervertebral disc space. The at least partially cured biomaterial and the at least one retention structure cooperate to comprise the prosthesis.
{0012] In one embodiment, the retention structure includes a band with openings opposite end plates of the adjacent vertebrae. The band is preferably oriented perpendicular relative to an axis of the spine to restrain the biomaterial from creating excessive pressure on the annular walls.
[0013] In another embodiment, the retention structure includes one or more collapsed retention structures adapted to expand when located in the intervertebral disc space. In another embodiment, the retention structure expands during delivery of the curable biomaterial.
[0014] The retention structure can be a discrete member or a plurality of retention structures adapted to be delivered sequentially through a lumen into the intervertebral disc space. The retention structure can be expandable and/or reorientable.
[0015] In another embodiment, the retention structure is adapted to be assembled within the intervertebral disc space. For example, the retention structure optionally includes a plurality of interlocking members that are assembled in situ. In one embodiment, the retention structure comprises a plurality of magnetic members that are assembled in situ. [0016] The retention structure can be one or more inflatable members, woven or non-woven mesh, or coiled or kinked members. The retention structure preferably includes a plurality of tension and compression members. The retention structure may include one or more of individual strands, coils, woven or non-woven webs, open cell foams, closed cell foams, combination of open and closed cell foams, scaffolds, cotton-ball fiber matrix, or a generally honeycomb retention structure.
[0017] In another embodiment, the retention structure includes a plurality of interconnected cavities. Fluid flow devices interposed between at least some of the interconnected cavities selectively control the flow of biomaterial into at least some of the cavities. The retention structure includes a plurality of discrete cavities at least a portion of which are at least partially filled with biomaterial.
[0018] The at least partially cured biomaterial preferably substantially encapsulates the retention structure. The retention structure when in the intervertebral disc space preferably comprises at least one cross-sectional area greater than a diameter of an opening in the lumen. [0019] The distal end of the lumen is optionally coupled to at least one retention structure. The lumen is optionally releasably attached to the retention structure. In one embodiment, at least one valve is provided to retain the biomaterial in the cavity after the lumen is removed.
[0020] One or more of the retention structure or the biomaterial optionally include a bioactive agent. In one embodiment, at least a portion of an anatomical annulus contains the retention structure and the curable biomaterial. In one embodiment, a mold optionally contains the retention structure and the curable biomaterial. The mold can be a balloon or a porous envelope.
[0021] The present invention is also directed to a method for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient. The method includes locating at least one retention structure in the intervertebral disc space. A distal end of at least a first lumen is located proximate at least one retention structure. One or more flowable, curable biomaterials is delivered into the intervertebral disc space through the first lumen. The flowable biomaterial engages with the retention structure located in the intervertebral disc space so that the retention structure retains at least a portion of the biomaterial in the intervertebral disc space. The at least partially cured biomaterial and the retention structures cooperating to comprise the prosthesis.
[0022] Minimally invasive refers to a surgical mechanism, such as microsurgical, percutaneous, or endoscopic or arthroscopic surgical mechanism. In one embodiment, the entire procedure is minimally invasive, for instance, through minimal incisions in the epidermis (e.g., incisions of less than about 6 centimeters, and more preferably less than 4 centimeters, and preferably less than about 2 centimeters). In another embodiment, the procedure is minimally invasive only with respect to the annular wall and/or pertinent musculature, or bony structure. Such surgical mechanism are typically accomplished by the use of visualization such as fiber optic or microscopic visualization, and provide a postoperative recovery time that is substantially less than the recovery time that accompanies the corresponding open surgical approach. Background on minimally invasive surgery can be found in German and Foley, Minimal Access Surgical Techniques in the Management of the Painful Lumbar Motion Segment, 30 SPINE 16S, n. S52— S59 (2005). [0023] Retention structure generally refers to the portion or portions of the present invention used to receive, constrain, shape and/or retain a flowable biomaterial in the intervertebral disc space during curing the biomaterial in situ. A retention structure may include or rely upon natural tissues (such as the annular shell of an intervertebral disc or the end plates of the adjacent vertebrae) for at least a portion of its conformation or function. For example, the retention structure may form a fully enclosed cavity or chamber or may rely on natural tissue for a portion thereof. The retention structure, in turn, is responsible, at least in part, for determining the position and final dimensions of the cured prosthetic implant. As such, its dimensions and other physical characteristics can be predetermined to provide an optimal combination of such properties as the ability to be delivered to a site using minimally invasive means, filled with biomaterial, control moisture contact, and optionally, then remain in place as or at the interface between cured biomaterial and natural tissue. In a particularly preferred embodiment the retention structure can itself become integral to the body of the cured biomaterial.
[0024] In some embodiments, the retention structure may be used in combination with a mold. Mold generally refers to a flexible member including at least one cavity for the receipt of biomaterial and at least one lumen to that cavity. Multiple molds, either discrete or connected, may be used in some embodiments. Some or all of the material used to form the mold will generally be retained in situ, in combination with the cured biomaterial, while some or the entire lumen will generally be removed upon completion of the procedure. The mold and/or lumens can be biodegradable or bioresorbable. Examples of biodegradable materials can be found in U.S. Publication Nos. 2005-0197422; 2005-0238683; and 2006-0051394, the disclosures of which are hereby incorporated by reference. The mold can be an impermeable, semi-permeable, or permeable membrane. In one embodiment, the mold is a highly permeable membrane, such as for example a woven or non-woven mesh or other durable, loosely woven fabrics. The mold and/or biomaterial can include or be infused with drugs, pH regulating agents, pain inhibitors, and/or growth stimulants.
[0025] Biomaterial generally refers to a material that is capable of being introduced to the site of a joint and cured to provide desired physical-chemical properties in vivo. In a preferred embodiment the term will refer to a material that is capable of being introduced to a site within the body using minimally invasive means, and cured or otherwise modified in order to cause it to be retained in a desired position and configuration. Generally such biomaterials are flowable in their uncured form, meaning they are of sufficient viscosity to allow their delivery through a lumen of on the order of about 1 mm to about 10 mm inner diameter, and preferably of about 2 mm to about 6 mm inner diameter. Such biomaterials are also curable, meaning that they can be cured or otherwise modified, in situ, at the tissue site, in order to undergo a phase or chemical change sufficient to retain a desired position and configuration.
[0026] The method and apparatus of the present invention uses one or more discrete access points or annulotomies into the intervertebral disc space, and/or through the adjacent vertebrae. The annulotomies facilitate performance of the nuclectomy, imaging or visualization of the procedure, delivery of the retention structure and biomaterial through one or more lumens, drawing a vacuum on a mold before, during and/or after delivery of the biomaterial, and securing the prosthesis in the intervertebral disc space during and after delivery of the biomaterial.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING [0027] Figure 1 is an exemplary prior art catheter and mold.
[0028] Figure 2 is a schematic illustration of various entry paths for use in accordance with the present invention.
[0029] Figures 3 A and 3 B are cross-sectional views of an annulus containing a mold assembly with one or more valves in accordance with the present invention. [0030] Figures 3 C and 3D are side sectional views of a mold assembly including a connector assembly in accordance with the present invention.
[0031] Figure 3 E is a cross-sectional view of the mold assembly of Figures 3 C and 3D implanted in a patient.
[0032] Figures 4A and 4B are cross-sectional views of an annulus containing a mold assembly with an alternate valves in accordance with the present invention. [0033] Figures 5A and 5B are cross-sectional views of an annulus containing a mold assembly with alternate valves in accordance with the present invention.
[0034] Figures 6A and 6B are cross-sectional views of an annulus containing a retention structure in the form of bands in accordance with the present invention.
[0035] Figures 6C and 6D are cross-sectional views of an annulus containing a mold assembly comprising a retention structure in accordance with the present invention.
[0036] Figures 7A and 7B are cross-sectional views of an annulus containing a prosthesis with an expandable retention structure in accordance with the present invention.
[0037] Figure 8 is a cross-sectional view of an annulus containing a prosthesis with an expandable retention structure in a mold in accordance with the present invention.
[0038] Figure 9 is a cross-sectional view of an annulus containing a prosthesis with an alternate expandable retention structure in accordance with the present invention.
[0039] Figures 1OA and 1OB are cross-sectional views of an annulus containing a prosthesis with a plurality of helical coils assembled into a retention structure in accordance with the present invention.
[0040] Figures 11 A and 11 B are cross-sectional views of an annulus containing a prosthesis with a plurality of spherical retention structures in accordance with the present invention.
[0041] Figure 12 is a cross-sectional view of an annulus containing a prosthesis with an assembled retention structure in accordance with the present invention.
[0042] Figure 13 is a cross-sectional view of an annulus containing a prosthesis with an alternate assembled retention structure in accordance with the present invention.
[0043] Figure 14 is a cross-sectional view of an annulus containing a prosthesis with a fibrous retention structure in accordance with the present invention.
[0044] Figure 15 A is a cross-sectional view of an annulus containing a prosthesis with an expandable honeycomb retention structure in accordance with the present invention.
[0045] Figures 15B and 15C are side and top sectional views of an annulus containing a prosthesis with an alternate expandable honeycomb structure in accordance with the present invention.
[0046] Figure 16 is a cross-sectional view of an annulus containing a mold assembly with multiple molds and a pressure activated retention structure in accordance with the present invention.
[0047] Figures 17A and 17B are cross-sectional views of an annulus containing variations of the mold assembly of Figure 16. [0048] Figures 18A and 18B are cross-sectional views of an annulus containing a mold assembly with multiple molds and an alternate pressure activated retention structure in accordance with the present invention.
[0049] Figure 18C is a cross-sectional view of the mold assembly of Figures 18A and
18B used in a mono-portal application in accordance with the present invention.
[0050] Figures 19 A and 19B are cross-sectional views of an annulus containing a mold assembly with patterned radiopaque markers in accordance with the present invention.
[0051] Figures 2OA and 2OB are cross-sectional views of an annulus containing a mold assembly with an alternate patterned radiopaque markers in accordance with the present invention.
[0052] Figure 21 is a cross-sectional view of an annulus containing a pair of nested molds in accordance with the present invention.
[0053] Figure 22 is a perspective view of the present mold assembly separating adjacent transverse processes in accordance with the present invention.
[0054] Figure 23 is a perspective view of the present mold assembly separating adjacent spinous processes in accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0055] Figure 2 is a cross-sectional view of a human body 20 showing various access paths 22 through 38 to the intervertebral disc 40 for performing the method of the present invention. The posterior paths 22, 24 extend either between superior and inferior transverse processes 42, or between the laminae (interlaminar path) on either side of the spinal cord 44. The posterolateral paths 26, 28 are also on opposite sides of the spinal cord 44 but at an angle of about 35-45 degrees relative to horizontal relative to the posterior paths 22, 24. The lateral paths 30, 32 extend through the side of the body. The anterior path 38 and anterolateral path 34 extend past the aorta iliac artery 46, while the anterolateral path 36 is offset from the inferior vena cava, iliac veins 48.
[0056] Depending on the disc level being operated on, and the patient anatomy. Generally, the aorta and vena cava split at the L4 vertebral body. At L5S1 the approach is typically a midline anterior approach. At L4/5 the approach may be either midline anterior or anterolateral, depending on the patient anatomy and how easy it is to retract the vessels. In some usages, the anterior approach is deemed a midline approach and the anterolateral approach is deemed an angled approach offset from the midline anterior approach. [0057] The present method and apparatus use one or more of the access paths 22 through 38. While certain of the access paths 22 through 38 may be preferred depending on a number of factors, such as the nature of the procedure, any of the access paths can be used with the present invention.
[0058] In one embodiment, delivery catheter instruments are positioned along two or more of the access paths 22 through 38 to facilitate preparation of the intervertebral disc 40.
Preparation includes, for example, formation of two or more annulotomies through the annular wall, removal of some or all of the nucleus pulposus to form a nuclear cavity, imaging of the annulus and/or the nuclear cavity, and positioning of the present multi-lumen mold in the nuclear cavity. In another embodiment, the present multi-lumen mold is positioned in the intervertebral disc 40 without use of delivery catheters.
[0059] Figure 3A illustrates one embodiment of a mold assembly 50 in accordance with the present invention. The mold assembly 50 includes lumen 52 fluidly coupled to mold 54.
In the illustrated embodiment, valve 56 is provided at the interface between the lumen 52 and the mold 54. In one embodiment, valve 58 is optionally located at a separate location on the mold 54.
[0060] The method of using the present mold assembly 50 involves forming an annulotomy 60 at a location in the annulus 62. The nucleus pulposus 64 located in the disc space 66 is preferably substantially removed to create a nuclear cavity 68. As illustrated in
Figure 3 A, some portion of the nucleus pulposus 64 may remain in the nuclear cavity 68 after the nuclectomy. The mold assembly 50 is then inserted through the annulotomy 60 so that the mold 54 is positioned in the nuclear cavity 68.
[0061] As illustrated in Figure 3B, biomaterial 70 is delivered through the lumen 52 into the mold 54. As the biomaterial 70 progresses through the mold 54, at least a portion of the air located in the mold 54 is preferably pushed out through the valve 58. In the illustrated embodiment, the valves 56 and 58 are preferably check valves that are forced into the closed position by the pressure of the biomaterial 70. Once delivery of the biomaterial 70 is substantially completed, the lumen 52 is detached from the mold 54 removed from the annulotomy 60. In the illustrated embodiment, the valve 56 permits the lumen 52 to be separated and removed before the biomaterial 70 has cured.
[0062] In one embodiment, one or more of the mold 54, the valves 56, 58, and/or the lumens 52 have radiopaque properties that facilitate imaging of the prosthesis 72 being formed. In another embodiment, the lumen 52 is releasably attached to the valve 56 to facilitate removal.
[0063] In one embodiment, the lumen 52 is threaded to the valve 56. In another embodiment, a quick release interface is used to attach the lumen 52 to the valve 56. [0064] Figures 3C and 3D are assembly views of a mold assembly 500 with a connection assembly 502 recessed in the mold 504 in accordance with the present invention. Open end 506 of the mold 504 is inserted into sleeve 508. The connector assembly 502 is then coupled to the sleeve 508. The open end 506 is secured between the sleeve 508 and connector assembly 502. In the illustrated embodiment, distal end of the connector assembly 502 includes a mechanical interface 510 that mechanically couples with the sleeve 508. The connector assembly 502 can be coupled to the open end 506 of the mold 504 and the sleeve 508 using a variety of techniques, such as adhesives, mechanical interlocks, fasteners, and the like.
[0065] The exposed end 512 of the connector assembly 502 preferably includes a mechanical interlock 514, such as for example internal threads, that couple with a corresponding interlock 516, such as external threads, on the lumen 518. As best illustrated in Figure 3E, the biomaterial 70 is retained in the mold by valve 520 preferably located in the connector assembly 502. In the illustrated embodiment, the connector assembly 502 and/or the valve 520 are substantially flush with the outer surface of the mold 504. In another embodiment, the connector assembly 502 may protrude above the outer surface of the mold 504. The lumen 518 is preferably removed from the mold assembly 500 before the biomaterial 70 is cured. The exposed mechanical interlock 514 on the connector assembly 502 can optionally be used to attach a securing device 522 to the prosthesis 524. [0066] Figure 4A illustrates an alternate mold assembly 80 in accordance with the present invention. Mold 82 includes a plurality of openings 84. The openings 84 can be any shape and a variety of sizes. Internal flaps 86 are located over the openings 84. As best illustrated in Figure 4B, biomaterial 70 is delivered through lumen 88 to the mold 82. Pressure from the biomaterial 70 presses the flaps 86 against the openings 84, substantially sealing the biomaterial 70 within the mold 82.
[0067] In one embodiment, the flaps 86 permit any air or biomaterial in the mold 82 to be pushed out through the openings 84 during delivery of the biomaterial 70. In another embodiment, the flaps 86 to not completely seal the openings 84 until the mold 82 is substantially inflated and pressing against inner surface 92 of the annulus 62. [0068] The flaps 86 can be constructed from the same or different material than the mold 82. In one embodiment, the flaps 86 are constructed from a radiopaque material that is easily visible using various imaging technologies. Prior to the delivery of the biomaterial 70, such as illustrated in Figure 4A, the spacing between the flaps 86 indicates that the mold 82 is not inflated. After delivery of the biomaterial 70, such as illustrated in Figure 4B, the spacing between the flaps 86 provides an indication of the shape and position of the intervertebral prosthesis 90 relative to the annulus 62. By strategically locating the openings 84 and flaps 86 around the outer surface of the mold 82, a series of images can be taken during delivery of the biomaterial 70 which will illustrate the prosthesis 90 during formation and provide reference points for evaluating whether the prosthesis 90 is properly positioned and fully inflated within the annulus 62.
[0069] Figure 5A illustrates an alternate mold assembly 100 in accordance with the present invention. Mold 102 includes a plurality of openings 104 with corresponding external flaps or valves 106. As best illustrated in Figure 5B, delivery of the biomaterial 70 causes the mold 102 to inflate. When the mold 102 is substantially inflated, the flaps 106 are pressed against the openings 104 by interior surface 108 of the nuclear cavity 68. [0070] In the illustrated embodiment, portion 110 of the biomaterial 70 forms a raised structure 1 12 over some or all of the openings 104. These raised structures serve to anchor the resulting prosthesis 1 14 in the nuclear cavity 68. Other examples of raised structures include barbs, spikes, hooks, and/or a high friction surface that can facilitate attachment to soft tissue and/or bone. Also illustrated in Figure 5B, portion 1 16 of the biomaterial 70 optionally escapes from the mold 102 prior to the flaps 106 being pressed against the openings 104. The portion 1 16 of the biomaterial 70 serves to adhere the prosthesis 114 to the inner surface 108 of the annulus 62. Again, one or more of the mold 102, the flaps 106 may include radiopaque properties.
[0071] Figures 6 A and 6B illustrate a prosthesis 136 including one or more retention structures 124, 126. In the illustrated embodiment, retention structure 124 is positioned horizontally between adjacent vertebrae 128, 130. Retention structure 126 is oriented perpendicular to the retention structure. Lumen 120 is preferably engaged with one or both of the retention structures 124, 126.
[0072] The retention structure preferably limits the amount of pressure the resulting prosthesis 136 places on the annular walls 62. A compressive force placed on the prosthesis 136 by the end plates 132, 134 is directed back towards the end plates, rather than horizontally into the annular wall 62. The retention structure preferably limits inflation of the mold 122 in the vertical direction. The retention structure can optionally be used to set a maximum disc height or separation between the adjacent vertebrae 128, 130 when the mold 122 is fully inflated.
[0073] In the illustrated embodiment, the retention structure 124, 126 are preferably radiopaque. As with the flaps 86, 106 of Figures 4 and 5, the retention structure 124, 126 provide an indication of the shape and position of the prosthesis 136 in the intervertebral disc space 138. As the biomaterial is delivered, the retention structures 124, 126 are deployed and positioned in accordance with the requirements of the prosthesis 136. A series of images can be taken of the intervertebral disc space 138 to map the progress of the prosthesis formation. Because the size and width of the retention structure 124, 126 are known prior to the procedure, the resulting images provide an accurate picture of the position of the prosthesis 136 relative to the vertebrae 128, 130.
[0074] In one embodiment, the retention structures 124, 126 are used in combination with mold 122. In an alternate embodiment, one or both of the retention structures 124, 126 can be located at the interior of the mold 122. The retention structures 124, 126 can optionally be attached to the mold 122.
[0075] Figures 6C and 6D illustrate a retention structure 142 in accordance with the present invention. The retention structure 142 is preferably positioned horizontally between adjacent vertebrae 128, 130. In the illustrated embodiment, the retention structure 142 also serves as a mold for retaining at least a portion of the biomaterial 70. The annulus wall 62 may also act to retain the biomaterial 70 in the intervertebral disc space. [0076] In one embodiment, the retention structure 142 preferably extends to the endplates 132, 134 so that the biomaterial 70 is substantially retained in center region 144 formed by the retention structure 142. In the embodiment of Figure 6C, the biomaterial 70 extends above and below the retention structure 142 to engage with the endplates 132, 134. As best illustrated in Figure 6D, the retention structure 142 is open at the top and bottom. In some embodiments, the biomaterial 70 may flow around the outside perimeter of the retention structure 142.
[0077] Figures 7 A and 7B illustrate an alternate prosthesis 158 in accordance with the present invention. Retention structure 154 configured in a compressed state is delivered into the nuclear cavity 68 of the annulus 62 through delivery lumen 156.
[0078] As best illustrated in Figure 7B, once the retention structure 154 is released from the delivery lumen 156, it assumes its original expanded shape within the nuclear cavity 68. The biomaterial 70 is delivered to the nuclear cavity 68, where it flows into and around the retention structure 154. The retention structure 154 serves to retain at least a portion of the biomaterial in the nuclear cavity 68 by surface tension, adhesion, mechanical capture, friction, viscosity, and a variety of other mechanisms. In an alternate embodiment, the retention structure 154 is deployed by the pressure of the biomaterial 70 being delivered into the nuclear cavity 68. [0079] In the illustrated embodiment, the retention structure 154 is a mesh woven to form a generally tubular structure. The mesh 154 can be constructed from a variety of metal, polymeric, biologic, and composite materials suitable for implantation in the human body. In one embodiment, the mesh operates primarily as a tension member within the prosthesis 158. Alternatively, the retention structure 154 is configured to act as both a tension and compression member within the prosthesis 158.
[0080] In another embodiment, the retention structure 154, or portions thereof, are constructed from a radiopaque material. In the expanded configuration illustrated in Figure 7B, the radiopaque elements of the retention structure 154 provide a grid or measuring device that is readily visible using conventional imaging techniques. The retention structure 154 thus provides a way to determine the shape, volume, dimensions, and position of the prosthesis 158 in the annular cavity 68.
[0081] Figure 8 illustrates an alternate prosthesis 160 with an internal retention structure 162 having a shape generally corresponding to the nuclear cavity 68. As illustrated in Figure 7, the retention structure 162 is compressed within the delivery lumen 156 (see Figure 7A) and delivered into mold 164 located in the nuclear cavity 68. Once in the expanded configuration illustrated in Figure 8, the retention structure 162 can operate as a tension and/or compression member within the prosthesis 160.
[0082] Figure 9 illustrates an alternate prosthesis 170 in accordance with the present invention. Retention structure 172 is again positioned in the nuclear cavity 68 in a compressed configuration through a delivery lumen 156 (see Figure 7A). The retention structure 172 is preferably constructed of a shape memory alloy (SMA), such as the nickel- titanium alloy Nitinol or of an elastic memory polymer that assumes a predetermined shape once released from the delivery lumen 156 or once a certain temperature is reached, such as for example the heat of the body. In the preferred embodiment, the retention structure 172 has radiopaque properties which can be used to facilitate imaging of the prosthesis 170. [0083] In another embodiment, the retention structure 172 is a mold configured with a coil shape. When inflated with biomaterial 70, the mold forms a coil-shaped retention structure. Additional biomaterial 70 is preferably delivered around the coil structure 172. [0084] Figures 1OA and 1OB illustrate an alternate prosthesis 188 in accordance with the present invention. A plurality of discrete helical retaining structures 182 are delivered through a delivery lumen 184 into the annular cavity 68. As best illustrated in Figure 1OB, the helical retaining structures 182 intertwine and become entangled within the annular cavity 68. In one embodiment, the helical retaining structures 182 are rotated during insertion to facilitate engagement with the retaining structures 182 already in the annular cavity 68. [0085] Alternatively, these retaining structures 182 can be kinked strands, which when compressed have a generally longitudinal orientation to provide easy delivery through the lumen 184. Once inside the annular cavity 68, the retaining structures 182 are permitted to expand or reorient. The cross-sectional area of the retaining structures 182 in the expanded or reoriented state is preferably greater than the diameter of the lumen 184, so as to prevent ejection during delivery of the biomaterial 70.
[0086] The plurality of retaining structures 182 are preferably discrete structures that act randomly and can be positioned independently. The discrete retaining structures 182 of the present invention can be delivered sequentially and interlocked or interengaged in situ. Alternatively, groups of the retaining structures 182 can be delivered together. [0087] Once the biomaterial 70 is delivered and at least partially cured, the relative position of the retaining structures 182 is set. The retaining structures 182 can act as spring members to provide additional resistance to compression and as tension members within the prosthesis 188. Some or all of the helical retaining structures 182 preferably have radiopaque properties to facilitate imaging of the prosthesis 188.
[0088] Figures 1 IA and 1 IB illustrate an alternate prosthesis 200 in accordance with the present invention. A plurality of retaining structures 204 are delivered into the nuclear cavity 68. Biomaterial 70 is then delivered to the nuclear cavity 68. The retention structures 204 assist in holding the biomaterial 70 in place. The retention structures 204 typically arrange themselves randomly within the intervertebral disc space 202.
[0089] In the illustrated embodiment, the retention structures 204 are a plurality of spherical members 206. The spherical members 206 flow and shift relative to each other within the intervertebral disc space 202. In one embodiment, the spherical members 206 are constructed from metal, ceramic, and/or polymeric materials. The spherical members 206 can also be a multi-layered structure, such as for example, a metal core with a polymeric outer layer.
[0090] In another embodiment, the spherical members 206 are hollow shells with openings into which the biomaterial 70 can flow. In this embodiment, the biomaterial 70 fills the hollow interior of the spherical members 206 and bonds adjacent spherical members 206 to each other. [0091] In one embodiment, the spherical members 206 have magnetic properties so they clump together within the intervertebral disc space 202 before the biomaterial 70 is delivered. Some or all of the spherical members 206 optionally have radiopaque properties. [0092] Figure 12 is a side sectional view of an intervertebral disc space 138 containing prosthesis 210 in accordance with the present invention. A plurality of polyhedron retention structures 212 are delivered into the intervertebral disc space 138 through lumen 216. For example, the retention structure can be pyramidal, tetrahedrons, and the like. In one embodiment, the pyramidal retention structures 212 have magnetic properties causing them to bind to each other within the intervertebral disc space 138. In another embodiment, the pyramidal retention structures 212 include a plurality of holes or cavities into which the biomaterial 70 flows, securing the retention structures 212 relative to each other and relative to the prosthesis 210.
[0093] Figure 13 is a side sectional view of an intervertebral disc space 138 with prosthesis 224 having coiled or loop shaped retention structures 220 in accordance with the present invention. The retention structures 220 can be compressed for delivery through the lumen 222, and allowed to expand once inside the nuclear cavity 68. Biomaterial 70 is then injected to secure the relative position of the retention structures 220 within the prosthesis 224.
[0094] The retention structures 220 are preferably constructed from a spring metal that helps maintain the separation between the adjacent vertebrae 128, 130. In one embodiment, the retention structures 220 are resilient and flex when loaded. In an alternate embodiment, the retention structures 220 are substantially rigid in at least one direction, while being compliant in another direction to permit insertion through the lumen 222. The retention structures 220 optionally define a minimum separation between the adjacent vertebrae 128, 130. The retention structures 220 can operate as tension and/or compression members. [0095] Figure 14 is a side sectional view of an alternate prosthesis 258 in accordance with the present invention. A plurality of reinforcing fibers 252 are delivered into the intervertebral disc space 254 through lumen 256. The biomaterial 70 is then delivered and secures the relative position of the reinforcing fibers 252 within the intervertebral disc space 138. The reinforcing fibers 252 can be in the form of individual strands, coils, woven or non- woven webs, open cell foams, closed cell foams, combination of open and closed cell foams, scaffolds, cotton-ball fiber matrix, or a variety of other structures. The reinforcing fibers 252 can be constructed from metal, ceramic, polymeric materials, or composites thereof. The reinforcing fibers 252 can operate as tension and/or compression members within prosthesis
258.
[0096] Figure 15 A is a side sectional view of an alternate prosthesis 278 in accordance with the present invention. A three-dimensional honeycomb structure 272 is compressed and delivered into the intervertebral disc space 274 through the lumen 276. Once in the expanded configuration, illustrated in Figure 15 A, the biomaterial 70 is delivered, fixing the honeycomb structure 272 in the illustrated configuration. In another embodiment, the delivery of the biomaterial expands or inflates the honeycomb structure 272.
[0097] The biomaterial 70 flows around and into the honeycomb structure 272 providing a highly resilient prosthesis 278. In one embodiment, the honeycomb structure 272 still retains its capacity to flex along with the biomaterial 70 when compressed by the adjacent vertebrae 128, 130. The honeycomb structure 272 can be constructed from a plurality of interconnected tension and/or compression members. In yet another embodiment, the honeycomb structure is an open cell foam.
[0098] In one embodiment, the honeycomb structure 272 has fluid flow devices, such as for example pores, holes of varying diameter or valves, interposed between at least some of the interconnected cavities 280. The fluid flow devices selectively controlling the flow of biomaterial 70 into at least some of the cavities 280 or filling the cavities 280 differentially, thus combining the different mechanical properties of the honeycomb structure 272 with the biomaterial 70 in an adaptable manner. The generally honeycomb structure 272 can optionally be combined with open or closed cell foam.
[0100] Figures 15B and 15C are side and top sectional views of a prosthesis 282 with a plurality of three-dimensional honeycomb structures 284A, 284B (referred to collectively as
"284") in accordance with the present invention. The honeycomb structures 284 are constructed so that the inflow of biomaterial 70 can be selectively directed to certain cavities
286. In alternate embodiments, more than two honeycomb structures 284A, 284B can optionally be used.
[0101] In one embodiment, holes interconnecting adjacent cavities 286 can be selectively opened or closed before the honeycomb structures 284 are inserted into the patient. In another embodiment, a plurality of lumens 288A, 288B, 288C, ... (referred to collectively as
"288") are provided that are each connected to a different cavity 286. One or more of the lumens 288 can also be used to evacuate the annular cavity 68.
[0102] Selective delivery of the biomaterial 70 into the honeycomb structures 284 can be used to create a variety of predetermined internal shapes. Using a plurality of lumens 288 permits different biomaterials 7OA, 7OB, 7OC, ... to be delivered to different cavities 286 within the honeycomb structure 284. The biomaterials 7OA, 7OB, 70C, ... can be selected based on a variety of properties, such as mechanical or biological properties, biodegradability, bioabsorbability, ability to delivery bioactive agents. As used herein, "bioactive agent" refers to cytokines and preparations with cytokines, microorganisms, plasmids, cultures of microorganisms, DNA-sequences, clone vectors, monoclonal and polyclonal antibodies, drugs, pH regulators, cells, enzymes, purified recombinant and natural proteins, growth factors, and the like.
[0103] Figure 16 illustrates an alternate mold assembly 300 in accordance with the present invention. In the illustrated embodiment, two annulotomies 6OA, 6OB are formed in the annulus 62. The mold assembly 300 is threaded through one of the annulotomies so that the lumens 302, 304 each protrude from annulotomies 6OA, 6OB, respectively. Lumen 302 is fluidly coupled to mold 306 while lumen 304 is fluidly coupled with mold 308. Retention structure 310 is attached to molds 306, 308 at the locations 312, 314, respectively. [0104] Figure 17A is a side sectional view of the mold assembly 300 of Figure 16 implanted between adjacent vertebrae 128, 130. Biomaterial 70 is delivered to the molds 306, 308, which applies opposing compressive forces 316 on the retention structure 310. In the illustrated embodiment, the retention structure 310 is a coil, loop, or bend (arc) of resilient material, such as a memory metal, spring metal, and the like. The resulting prosthesis 312 includes a pair of molds 306, 308 containing a cured biomaterial 70 holding the retention structure 310 against adjacent end plates 132, 136 of the vertebrae 128, 130 respectively. The retention structure can serve to resist compression of the prosthesis 312 or to establish a minimum separation between the adjacent end plates 132, 134.
[0105] Figure 17B is an alternate embodiment of the mold assembly 300 of Figure 16. In the illustrated embodiment, retention structure 310 includes a series of fold lines or hinges 318. Expansion of the molds 306, 308 with biomaterial 70 generates forces 316 that converts the generally flat retention structure 310 (see Figure 16) into the shaped retention structure 322 illustrated in Figure 17B. Alternatively, the hinge 318 could be facing the molds 306, 308 rather than the endplates. In the embodiments of Figures 17A and 17B, delivery of the biomaterial 70 deploys the retention structure 310 to an expanded configuration. [0106] Figures 18A and 18B illustrate an alternate mold assembly 350 in accordance with the present invention. Lumens 352, 354 extend into the annulus 62 through different annulotomies 6OA, 6OB. Lumen 352 is fluidly coupled with mold 356 and lumen 354 is fluidly coupled with mold 358. Reinforcing mesh structure 364 is connected to the molds 356, 358 at locations 360, 362, respectively. As illustrated in Figure 18B, biomaterial 70 is delivered to the molds 356, 358 causing the retention structure 364 to be compressed and/or stretched within the nuclear cavity 68.
[0107] In one embodiment, additional biomaterial 70 can optionally be delivered into the nuclear cavity 68 proximate the retention structure 364. In the illustrated embodiment, the same or a different biomaterial 7OA flows around and into the retention structure 364. The biomaterial 7OA bonds the retention structure 364 to the annulus 62. The resulting prosthesis 366 has three distinct regions of resiliency. The areas of varying resiliency can be tailored for implants that would be implanted via different surgical approaches, as well as various disease states. The retention structure 364 optionally includes radiopaque properties. A series of images taken during delivery of the biomaterial 70 illustrates the expansion and position of the prosthesis 366 in the nuclear cavity 68.
[0108] Figure 18C is an alternate configuration of the mold assembly 350 for use with mono-portal applications in accordance with the present invention. Lumens 352, 354 extend into the annulus 62 through a single annulotomy 60. Lumen 352 is fluidly coupled with mold 356 and lumen 354 is fluidly coupled with mold 358. Reinforcing mesh structure 364 is connected to the molds 356, 358 at locations 360, 362, respectively. As illustrated in Figure 18B, delivery of the biomaterial 70 causing the retention structure 364 to be compressed and/or stretched within the nuclear cavity 68. Additional biomaterial 7OA can optionally be delivered into the nuclear cavity 68 proximate the retention structure 364. [0109] Figures 19A and 19B are side sectional views of mold assembly 400 in accordance with the present invention. The mold 402 includes a plurality of radiopaque markers 404. In the illustrated embodiment, the radiopaque markers 404 are arranged in a predetermined pattern around the perimeter of the mold 402. As best illustrated in Figure 19B, once the mold 402 is inflated with the biomaterial, the spacing 406 between the adjacent radiopaque markers 404 increases. By imaging the intervertebral disc space 138 before, during and after delivery of the biomaterial 70, a series of images can be generated showing the change in the spacing between the radiopaque markers 404. Because the spacing between the radiopaque markers 404 is known prior to delivery of the biomaterial, it is possible to calculate the shape and position of the prosthesis 408 illustrated in Figure 19B using conventional imaging procedures.
[0110] Figures 2OA and 2OB illustrate an alternate mold assembly 420 in accordance with the present invention. Mold 422 includes a plurality of radiopaque strips 424 located strategically around its perimeter. When the mold 422 is inflated with biomaterial, the spacing 426 between the radiopaque strips 424 changes, providing an easily imageable indication of the shape and position of the prosthesis 428 in the intervertebral disc space 138. [0111] Figure 21 illustrates an alternate mold assembly 450 in accordance with the present invention. Inner mold 452 is fluidly coupled to lumen 454. Outer mold 456 is fluidly coupled to lumen 458. Biomaterial is delivered through the lumen 454 into the inner mold 452. A radiopaque fluid is preferably delivered to the space 460 between the inner mold 452 and the outer mold 456.
[0112] In one embodiment, as the biomaterial 70 is delivered to the inner mold 452, the radiopaque material 462 located in the space 460 is expelled from the nuclear cavity 68 through the lumen 458. A series of images of the annulus 62 will show the progress of the biomaterial 70 expanding the inner mold 452 within the nuclear cavity 68 and the flow of the radiopaque fluid 462 out of the space 460 through the lumen 458.
[0113] In another embodiment, once the delivery of the biomaterial 70 is substantially completed and the radiopaque material 462 is expelled from the space 460, a biological material or bioactive agent is injected into the space 460 through the delivery lumen 458. In one embodiment, the outer mold 456 is sufficiently porous to permit the bioactive agent to be expelled into the annular cavity 68, preferably over a period of time. One of the molds 452, 456 optionally includes radiopaque properties. The mold 456 is preferably biodegradable or bioresorbable with a half life greater than the time required to expel the bioactive agents. [0114] In another embodiment, one or more retention structures 464, such as disclosed herein, is located in the space 460 between the inner and outer molds 452, 456. For example, the retention structure 464 may be a woven or non-woven mesh impregnated with the bioactive agent. In another embodiment, the retention structure 464 and the outer mold 456 are a single structure, such as a reinforcing mesh impregnated with the bioactive agent. In yet another embodiment, the outer mold 456 may be a stent-like structure, preferably coated with one or more bioactive agents.
[0115] Figures 22 and 23 illustrate use of a mold assembly 550 to maintain the separation between spinous process 552 and/or transverse processes 554 on adjacent vertebrae 556, 558 in according with the present method and apparatus. The mold assembly 550 may be used alone or in combination with an intervertebral mold assembly, such as discussed herein. The mold assembly 550 can also be used to separate the superior articulating process and inferior articulating process, more commonly referred to as the facet joint, on adjacent vertebrae. [0116] In the illustrated embodiment, the mold 560 preferable includes extension 562, 564 that couple or engage with the spinous process or transverse processes 552, 554. Center portion 566 acts as a spacer to maintain the desired separation. In one embodiment, the mold assembly has an H-shaped or figure-8 shaped cross section to facilitate coupling with the various facets on the adjacent vertebral bodies. Attachment of the molds 550 or 560 to the spinous or transverse processes may be further facilitated using sutures, cables, ties, rivets, screws, clamps, sleeves, collars, adhesives, or the like. Any of the mold assemblies and retention structures disclosed herein can be used with the mold assembly 550. [0117] Any of the features disclosed herein can be combined with each other and/or with features disclosed in commonly assigned U.S. Patent Application Serial No. 11/268,786, entitled Multi-Lumen Mold for Intervertebral Prosthesis and Method of Using Same, filed November 8, 2005, which is hereby incorporated by reference. Any of the molds and/or lumens disclosed herein can optionally be constructed from biodegradable or bioresorbable materials. The lumens disclosed herein can be constructed from a rigid, semi-rigid, or pliable high tensile strength material. The various components of the mold assemblies disclosed herein may be attached using a variety of techniques, such as adhesives, solvent bonding, mechanical deformation, mechanical interlock, or a variety of other techniques. [0118] The mold assembly of the present invention is preferably inserted into the nuclear cavity 68 through a catheter, such as illustrated in commonly assigned U.S. Patent Application Serial No. 1 1/268,876 entitled Catheter Holder for Spinal Implants, filed November 8, 2005, which is hereby incorporated by reference.
[0119] Various methods of performing the nuclectomy are disclosed in commonly assigned U.S. Patent Serial No. 1 1/304,053 entitled Total Nucleus Replacement Method, filed on December 15, 2005, which is incorporated by reference. Disclosure related to evaluating the nuclectomy or the annulus and delivering the biomaterial 70 are found in commonly assigned U.S. Patent Application Serial No. 10/984,493, entitled Multi-Stage Biomaterial Injection System for Spinal Implants, filed November 9, 2004, which is incorporated by reference. Various implant procedures and biomaterials related to intervertebral disc replacement suitable for use with the present multi-lumen mold are disclosed in U.S. Patents Nos. 5,556,429 (Felt); 6,306,177 (Felt, et al.); 6,248,131 (Felt, et al); 5,795,353 (Felt); 6,079,868 (Rydell); 6,443,988 (Felt, et al.); 6,140,452 (Felt, et al.); 5,888,220 (Felt, et al.); 6,224,630 (Bao, et al.), and U.S. Patent Application Nos. 10/365,868 and 10/365,842, all of which are hereby incorporated by reference. The present mold assemblies can also be used with the method of implanting a prosthetic nucleus disclosed in a commonly assigned U.S. Patent Application Serial No. 1 1/268,856, entitled Lordosis Creating Nucleus Replacement Method and Apparatus, filed on November 8, 2005, which are incorporated herein by reference.
[0120] The mold assemblies and methods of the present invention can also be used to repair other joints within the spine such as the facet joints, as well as other joints of the body, including diarthroidal and amphiarthroidal joints. Examples of suitable diarthroidal joints include the ginglymus (a hinge joint, as in the interphalangeal joints and the joint between the humerus and the ulna); throchoides (a pivot joint, as in superior radio-ulnar articulation and atlanto-axial joint); condyloid (ovoid head with elliptical cavity, as in the wrist joint); reciprocal reception (saddle joint formed of convex and concave surfaces, as in the carpometacarpal joint of the thumb); enarthrosis (ball and socket joint, as in the hip and shoulder joints) and arthrodia (gliding joint, as in the carpal and tarsal articulations). [0121] The present mold apparatus can also be used for a variety of other procedures, including those listed above. The present mold assembly can also be used to modify the interspinous or transverse process space. The mold can operate as a spacer/distractor between the inferior and superior spinous processes, thus creating a local distraction and kyphosis of wanted. The theory behind these implants is that they expand the intervertebral foramen and thereby relieve pressure on the nerve root and spinal cord. The present injectable prosthesis is adapted to the individual anatomy and clinical situation of the patient, without the need for multiple implant sizes.
[0122] Patents and patent applications disclosed herein, including those cited in the Background of the Invention, are hereby incorporated by reference. Other embodiments of the invention are possible. Many of the features of the various embodiments can be combined with features from other embodiments. For example, any of the securing mechanisms disclosed herein can be combined with any of the multi-lumen molds. It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

What is claimed is:
1. An assembly for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient, the assembly comprising: at least one retention structure adapted to be located in the intervertebral disc space; at least a first lumen having a distal end proximate the intervertebral disc space; and one or more in situ curable biomaterials adapted to be delivered to the intervertebral disc space through the first lumen and into engagement with the retention structure, the retention structure serving to retain at least a portion of the biomaterial in the intervertebral disc space, wherein the at least partially cured biomaterial and the at least one retention structure cooperate to comprise the prosthesis.
2. The assembly of claim 1 wherein the retention structure comprises a generally planar structure with openings opposite end plates of the adjacent vertebrae.
3. The assembly of claim 1 wherein the retention structure comprises one or more collapsed retention structures adapted to expand when located in the intervertebral disc space.
4. The assembly of claim 1 wherein the retention structure comprises one or more collapsed retention structures adapted to expands during delivery of the curable biomaterial.
5. The assembly of claim 1 wherein the retention structure comprises a plurality of retention structures adapted to be delivered sequentially through a lumen into the intervertebral disc space.
6. The assembly of claim 1 wherein the retention structure comprises an expandable or reorientable retention structure.
7. The assembly of claim 1 wherein the retention structure is adapted to be assembled within the intervertebral disc space.
8. The assembly of claim 1 wherein the retention structure comprises a plurality of interlocking members.
9. The assembly of claim 1 wherein the retention structure comprises one or more inflatable members.
10. The assembly of claim 1 wherein the retention structure comprises a plurality of tension and compression members.
11. The assembly of claim 1 wherein the retention structure comprises a woven or a non- woven member.
12. The assembly of claim 1 wherein the retention structure comprises one or more coiled or kinked members.
13. The assembly of claim 1 wherein the retention structure comprises a plurality of magnetic members.
14. The assembly of claim 1 wherein the retention structure comprise one or more of individual strands, coils, woven or non-woven webs, open cell foams, closed cell foams, combination of open and closed cell foams, scaffolds, cotton-ball fiber matrix, or a generally honeycomb retention structure.
15. The assembly of claim 1 wherein the retention structure comprises: a plurality of interconnected cavities; and fluid flow devices interposed between at least some of the interconnected cavities, the fluid flow devices selectively controlling the flow of biomaterial into at least some of the cavities.
16. The assembly of claim 1 wherein the retention structure comprises a plurality of discrete cavities at least a portion of which are at least partially filled with biomaterial.
17. The assembly of claim 1 wherein the lumen is coupled to at least one retention structure.
18. The assembly of claim 1 wherein the retention structure comprises a mesh.
19. The assembly of claim 1 wherein the retention structure comprises an expandable mesh.
20. The assembly of claim 1 wherein the at least partially cured biomaterial substantially encapsulates the retention structure.
21. The assembly of claim 1 wherein the retention structure when in the intervertebral disc space comprises at least one cross-sectional area greater than a diameter of an opening in the first lumen.
22. The assembly of claim 1 wherein the intervertebral disc space comprises an annular member with an opening and the retention structure comprises at least one cross- sectional area greater than a diameter of the opening.
23. The assembly of claim 1 wherein the lumen is releasably attached to the retention structure.
24. The assembly of claim 1 comprising at least one valve adapted to retain the biomaterial in the cavity after the lumen is removed.
25. The assembly of claim 1 wherein one or more of the retention structure or the biomaterial comprises a bioactive agent.
26. The assembly of claim 1 wherein delivery of the biomaterial positions the retention structure relative to the intervertebral disc space.
27. The assembly of claim 1 wherein the prosthesis comprises one of a nucleus replacement device, a partial nucleus replacement device, or a total disc replacement device.
28. The assembly of claim 1 wherein the retention structures is adapted to be delivered using minimally invasive techniques.
29. The assembly of claim 1 wherein at least a portion of an anatomical annulus contains the retention structure and the curable biomaterial.
30. The assembly of claim 1 comprising a mold containing the retention structure and the curable biomaterial.
31. The assembly of claim 1 wherein the distal end of the first lumen is engaged with the retention structure.
32. An assembly for in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient, the assembly comprising: at least one retention structure adapted to be located in the intervertebral disc space, the retention structure filling less than the entire intervertebral disc space; at least a first lumen having a distal end fluidly coupled to the at least one retention structure; and one or more in situ curable biomaterials adapted to be delivered to the intervertebral disc space through the first lumen, the retention structure retaining at least a portion of the biomaterial in the intervertebral disc space, wherein an at least partially cured biomaterial and the at least one retention structure cooperate to comprise the prosthesis.
33. A method for the in situ formation of a prosthesis in an intervertebral disc space between adjacent vertebrae of a patient, comprising the steps of: locating at least one retention structure in the intervertebral disc space; locating a distal end of at least a first lumen proximate at least one retention structure; delivering one or more fiowable, curable biomaterials into the intervertebral disc space through the first lumen; engaging the fiowable biomaterial with the retention structure located in the intervertebral disc space so that the retention structure retains at least a portion of the biomaterial in the intervertebral disc space; and at least partially curing the biomaterial, the at least partially cured biomaterial and the retention structures cooperating to comprise the prosthesis.
34. The method of claim 33 wherein the retention structure retains the curable biomaterial by one or more of surface tension, adhesion, mechanical capture, friction, and viscosity.
35. The method of claim 33 comprising the steps of: collapsing one or more retention structures; and expanding the retention structure in the intervertebral disc space.
36. The method of claim 33 comprising expanding the retention structure in response to delivery of the curable biomaterial.
37. The method of claim 33 comprising delivering a plurality of retention structure sequentially through a lumen into the intervertebral disc space.
38. The method of claim 33 comprising reorienting the retention structure in the intervertebral disc space.
39. The method of claim 33 comprising assembling the retention structures within the intervertebral disc space.
40. The method of claim 33 comprising interlocking a plurality of retention structure within the intervertebral disc space.
41. The method of claim 33 comprising inflating the retention structure within the intervertebral disc space.
42. The method of claim 33 wherein the retention structure comprises a plurality of interconnected cavities and the method comprises selectively controlling the flow of biomaterial into at least some of the cavities.
43. The method of claim 33 comprising coupling the lumen to at least one retention structure.
44. The method of claim 33 comprising at least partially encapsulating the retention structure in the at least partially cured biomaterial.
45. The method of claim 33 comprising delivering the retention structure using minimally invasive techniques.
46. The method of claim 33 retaining at least a portion of the curable biomaterial in the intervertebral disc space using a portion of an anatomical annulus.
47. The method of claim 33 comprising locating the retention structure and the curable biomaterial within a mold.
PCT/US2009/053768 2008-09-03 2009-08-13 Retention structure for in situ formation of an intervertebral prosthesis WO2010027622A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010080337A1 (en) * 2008-12-18 2010-07-15 Disc Dynamics, Inc. Inflatable mold for maintaining posterior spinal elements in a desired alignment

Families Citing this family (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10154163A1 (en) * 2001-11-03 2003-05-22 Advanced Med Tech Device for straightening and stabilizing the spine
WO2004019815A2 (en) * 2002-08-27 2004-03-11 Sdgi Holdings, Inc. Systems and methods for intravertebral reduction
US20050055094A1 (en) * 2002-11-05 2005-03-10 Kuslich Stephen D. Semi-biological intervertebral disc replacement system
US20070049849A1 (en) * 2005-05-24 2007-03-01 Schwardt Jeffrey D Bone probe apparatus and method of use
US20070042326A1 (en) * 2005-06-01 2007-02-22 Osseous Technologies Of America Collagen antral membrane expander
PL2124831T3 (en) 2007-03-15 2017-03-31 Ortho-Space Ltd. Prosthetic devices
CN105213010A (en) 2008-01-14 2016-01-06 康文图斯整形外科公司 For the apparatus and method of fracture repair
US8636803B2 (en) * 2009-04-07 2014-01-28 Spinal Stabilization Technologies, Llc Percutaneous implantable nuclear prosthesis
CH701006A2 (en) * 2009-05-11 2010-11-15 Marcel Dr Med Capaul Disc pads.
US20110190774A1 (en) * 2009-11-18 2011-08-04 Julian Nikolchev Methods and apparatus for performing an arthroscopic procedure using surgical navigation
US9700425B1 (en) 2011-03-20 2017-07-11 Nuvasive, Inc. Vertebral body replacement and insertion methods
WO2013057566A2 (en) * 2011-10-18 2013-04-25 Ortho-Space Ltd. Prosthetic devices and methods for using same
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
US9433404B2 (en) 2012-10-31 2016-09-06 Suture Concepts Inc. Method and apparatus for closing fissures in the annulus fibrosus
US20140277467A1 (en) 2013-03-14 2014-09-18 Spinal Stabilization Technologies, Llc Prosthetic Spinal Disk Nucleus
US9295479B2 (en) 2013-03-14 2016-03-29 Spinal Stabilization Technologies, Llc Surgical device
AU2014306454B2 (en) 2013-08-16 2019-06-13 Suture Concepts 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
WO2015039104A2 (en) 2013-09-16 2015-03-19 Neuraxis, Llc Methods and devices for applying localized thermal therapy
WO2015038200A1 (en) 2013-09-16 2015-03-19 Neuraxis, Llc Implantable devices for thermal therapy and related methods
US10786360B2 (en) 2014-11-04 2020-09-29 Spinal Stabilization Technologies Llc Percutaneous implantable nuclear prosthesis
US10314714B2 (en) 2014-11-04 2019-06-11 Spinal Stabilization Technologies Llc Percutaneous implantable nuclear prosthesis
US10709570B2 (en) 2015-04-29 2020-07-14 Institute for Musculoskeletal Science and Education, Ltd. Implant with a diagonal insertion axis
EP3760166A1 (en) 2015-04-29 2021-01-06 Institute For Musculoskeletal Science And Education, Ltd. Coiled implants and systems
US10449051B2 (en) 2015-04-29 2019-10-22 Institute for Musculoskeletal Science and Education, Ltd. Implant with curved bone contacting elements
US10492921B2 (en) 2015-04-29 2019-12-03 Institute for Musculoskeletal Science and Education, Ltd. Implant with arched bone contacting elements
PL3344156T3 (en) 2015-09-01 2020-07-27 Spinal Stabilization Technologies Llc Implantable nuclear prosthesis
US10959761B2 (en) 2015-09-18 2021-03-30 Ortho-Space Ltd. Intramedullary fixated subacromial spacers
US9486323B1 (en) * 2015-11-06 2016-11-08 Spinal Stabilization Technologies Llc Nuclear implant apparatus and method following partial nuclectomy
US10267261B2 (en) * 2016-08-01 2019-04-23 GM Global Technology Operations LLC Methods of joining components in vehicle assemblies
US10478312B2 (en) 2016-10-25 2019-11-19 Institute for Musculoskeletal Science and Education, Ltd. Implant with protected fusion zones
US11213402B2 (en) 2017-01-11 2022-01-04 Loubert S. Suddaby Endoscopically implantable inflatable interbody fusion device
US11045981B2 (en) 2017-01-30 2021-06-29 Ortho-Space Ltd. Processing machine and methods for processing dip-molded articles
US10631881B2 (en) 2017-03-09 2020-04-28 Flower Orthopedics Corporation Plating depth gauge and countersink instrument
US10512549B2 (en) 2017-03-13 2019-12-24 Institute for Musculoskeletal Science and Education, Ltd. Implant with structural members arranged around a ring
US10213317B2 (en) 2017-03-13 2019-02-26 Institute for Musculoskeletal Science and Education Implant with supported helical members
US10667924B2 (en) 2017-03-13 2020-06-02 Institute for Musculoskeletal Science and Education, Ltd. Corpectomy implant
US10357377B2 (en) 2017-03-13 2019-07-23 Institute for Musculoskeletal Science and Education, Ltd. Implant with bone contacting elements having helical and undulating planar geometries
US10918426B2 (en) 2017-07-04 2021-02-16 Conventus Orthopaedics, Inc. Apparatus and methods for treatment of a bone
US10744001B2 (en) 2017-11-21 2020-08-18 Institute for Musculoskeletal Science and Education, Ltd. Implant with improved bone contact
US10695192B2 (en) 2018-01-31 2020-06-30 Institute for Musculoskeletal Science and Education, Ltd. Implant with internal support members
CA3111639A1 (en) 2018-09-04 2020-05-28 Spinal Stabilization Technologies, Llc Implantable nuclear prosthesis, kits, and related methods
US11129727B2 (en) 2019-03-29 2021-09-28 Medos International Sari Inflatable non-distracting intervertebral implants and related methods
US20230100415A1 (en) * 2021-09-29 2023-03-30 Cilag Gmbh International Surgical sealing systems for instrument stabilization

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070276491A1 (en) * 2006-05-24 2007-11-29 Disc Dynamics, Inc. Mold assembly for intervertebral prosthesis

Family Cites Families (156)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4545374A (en) 1982-09-03 1985-10-08 Jacobson Robert E Method and instruments for performing a percutaneous lumbar diskectomy
EP0176728B1 (en) * 1984-09-04 1989-07-26 Humboldt-Universität zu Berlin Intervertebral-disc prosthesis
US4834757A (en) * 1987-01-22 1989-05-30 Brantigan John W Prosthetic implant
US6770074B2 (en) 1988-06-13 2004-08-03 Gary Karlin Michelson Apparatus for use in inserting spinal implants
US5484437A (en) 1988-06-13 1996-01-16 Michelson; Gary K. Apparatus and method of inserting spinal implants
AU7139994A (en) * 1988-06-13 1995-01-03 Karlin Technology, Inc. Apparatus and method of inserting spinal implants
AU624627B2 (en) 1988-08-18 1992-06-18 Johnson & Johnson Orthopaedics, Inc. Functional and biocompatible intervertebral disc spacer containing elastomeric material of varying hardness
US4969888A (en) 1989-02-09 1990-11-13 Arie Scholten Surgical protocol for fixation of osteoporotic bone using inflatable device
US5331975A (en) * 1990-03-02 1994-07-26 Bonutti Peter M Fluid operated retractors
US5163949A (en) 1990-03-02 1992-11-17 Bonutti Peter M Fluid operated retractors
US5047055A (en) 1990-12-21 1991-09-10 Pfizer Hospital Products Group, Inc. Hydrogel intervertebral disc nucleus
US5269797A (en) 1991-09-12 1993-12-14 Meditron Devices, Inc. Cervical discectomy instruments
US5285795A (en) * 1991-09-12 1994-02-15 Surgical Dynamics, Inc. Percutaneous discectomy system having a bendable discectomy probe and a steerable cannula
US5395317A (en) * 1991-10-30 1995-03-07 Smith & Nephew Dyonics, Inc. Unilateral biportal percutaneous surgical procedure
US5762629A (en) * 1991-10-30 1998-06-09 Smith & Nephew, Inc. Oval cannula assembly and method of use
US5599352A (en) * 1992-03-19 1997-02-04 Medtronic, Inc. Method of making a drug eluting stent
DE4300064A1 (en) 1993-01-05 1994-07-07 Wolf Gmbh Richard Tissue punch
US5413576A (en) * 1993-02-10 1995-05-09 Rivard; Charles-Hilaire Apparatus for treating spinal disorder
PT1092395E (en) * 1993-06-10 2004-08-31 Karlin Technology Inc PROTECTIVE DEVICE HAVING A FIRST AND SECOND PASSAGE FOR SPECIAL DISORDER SURGERY
FR2706309B1 (en) * 1993-06-17 1995-10-06 Sofamor Instrument for surgical treatment of an intervertebral disc by the anterior route.
US5314432A (en) * 1993-08-05 1994-05-24 Paul Kamaljit S Lumbar spinal disc trocar placement device
US5425772A (en) * 1993-09-20 1995-06-20 Brantigan; John W. Prosthetic implant for intervertebral spinal fusion
EP0650738B1 (en) 1993-10-28 2003-05-02 Medrad, Inc. Multi-patient fluid dispensing
DE4340707C2 (en) * 1993-11-30 1997-03-27 Wolf Gmbh Richard manipulator
EP1498079A1 (en) * 1994-01-26 2005-01-19 Kyphon Inc. Improved device for use in surgical protocol relating to fixation of bone
US6248110B1 (en) * 1994-01-26 2001-06-19 Kyphon, Inc. Systems and methods for treating fractured or diseased bone using expandable bodies
CA2144211C (en) 1994-03-16 2005-05-24 David T. Green Surgical instruments useful for endoscopic spinal procedures
US5620458A (en) * 1994-03-16 1997-04-15 United States Surgical Corporation Surgical instruments useful for endoscopic spinal procedures
DE4411099C2 (en) 1994-03-30 1998-07-30 Wolf Gmbh Richard Surgical instrument
US5888220A (en) * 1994-05-06 1999-03-30 Advanced Bio Surfaces, Inc. Articulating joint repair
US6140452A (en) 1994-05-06 2000-10-31 Advanced Bio Surfaces, Inc. Biomaterial for in situ tissue repair
US5556429A (en) 1994-05-06 1996-09-17 Advanced Bio Surfaces, Inc. Joint resurfacing system
US6248131B1 (en) * 1994-05-06 2001-06-19 Advanced Bio Surfaces, Inc. Articulating joint repair
AU2621295A (en) * 1994-05-24 1995-12-18 Smith & Nephew Plc Intervertebral disc implant
US5527312A (en) * 1994-08-19 1996-06-18 Salut, Ltd. Facet screw anchor
CA2159685C (en) 1994-10-07 2007-07-31 Scott W. Larsen Endoscopic surgical instruments useful for spinal procedures
US5562736A (en) 1994-10-17 1996-10-08 Raymedica, Inc. Method for surgical implantation of a prosthetic spinal disc nucleus
US5584855A (en) 1995-04-27 1996-12-17 Onik; Gary M. Safety surgical grasping forceps
US5980504A (en) 1996-08-13 1999-11-09 Oratec Interventions, Inc. Method for manipulating tissue of an intervertebral disc
US5645597A (en) * 1995-12-29 1997-07-08 Krapiva; Pavel I. Disc replacement method and apparatus
WO1997034536A2 (en) * 1996-03-22 1997-09-25 Sdgi Holdings, Inc. Devices and methods for percutaneous surgery
US5792044A (en) * 1996-03-22 1998-08-11 Danek Medical, Inc. Devices and methods for percutaneous surgery
US5788625A (en) 1996-04-05 1998-08-04 Depuy Orthopaedics, Inc. Method of making reconstructive SIS structure for cartilaginous elements in situ
DE19625729C2 (en) * 1996-06-27 1999-09-02 Wolf Gmbh Richard Support arm system
US5785647A (en) * 1996-07-31 1998-07-28 United States Surgical Corporation Surgical instruments useful for spinal surgery
US6126682A (en) 1996-08-13 2000-10-03 Oratec Interventions, Inc. Method for treating annular fissures in intervertebral discs
DE19637266C1 (en) * 1996-09-13 1997-12-04 Wolf Gmbh Richard Coupling for connecting hose to medical instrument, apparatus or with another hose
TW375522B (en) 1996-10-24 1999-12-01 Danek Medical Inc Devices for percutaneous surgery under direct visualization and through an elongated cannula
EP0873145A2 (en) * 1996-11-15 1998-10-28 Advanced Bio Surfaces, Inc. Biomaterial system for in situ tissue repair
DE19710432C2 (en) * 1997-03-13 2002-08-14 Wolf Gmbh Richard needle holder
US5800549A (en) 1997-04-30 1998-09-01 Howmedica Inc. Method and apparatus for injecting an elastic spinal implant
US6033438A (en) * 1997-06-03 2000-03-07 Sdgi Holdings, Inc. Open intervertebral spacer
US6022376A (en) * 1997-06-06 2000-02-08 Raymedica, Inc. Percutaneous prosthetic spinal disc nucleus and method of manufacture
GB9714580D0 (en) * 1997-07-10 1997-09-17 Wardlaw Douglas Prosthetic intervertebral disc nucleus
ATE520356T1 (en) * 1997-09-26 2011-09-15 Cryolife Inc SEAMLESS ANASTOMOTIS DEVICE
US6146420A (en) 1997-12-10 2000-11-14 Sdgi Holdings, Inc. Osteogenic fusion device
US6079868A (en) * 1997-12-18 2000-06-27 Advanced Bio Surfaces, Inc. Static mixer
AT405367B (en) * 1998-01-23 1999-07-26 Fuss Franz K Dipl Biomech Dr Implant
EP1056413A4 (en) * 1998-02-27 2003-08-20 Bioelastics Res Ltd Injectable implants for tissue augmentation and restoration
JPH11268295A (en) 1998-03-25 1999-10-05 Sharp Corp Facsimile
DE19817698A1 (en) * 1998-04-22 1999-10-28 Jan Zoellner Composition used for flat disk implant, especially nucleus pulposus implant
US6224630B1 (en) * 1998-05-29 2001-05-01 Advanced Bio Surfaces, Inc. Implantable tissue repair device
US6231609B1 (en) * 1998-07-09 2001-05-15 Hamid M. Mehdizadeh Disc replacement prosthesis
US6648895B2 (en) 2000-02-04 2003-11-18 Sdgi Holdings, Inc. Methods and instrumentation for vertebral interbody fusion
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
AU4810800A (en) 1999-04-26 2000-11-10 Li Medical Technologies, Inc. Prosthetic apparatus and method
US6533799B1 (en) * 1999-04-27 2003-03-18 Ams Research Corporation Cavity measurement device and method of assembly
US6224599B1 (en) * 1999-05-19 2001-05-01 Matthew G. Baynham Viewable wedge distractor device
US6969404B2 (en) * 1999-10-08 2005-11-29 Ferree Bret A Annulus fibrosis augmentation methods and apparatus
US6491724B1 (en) * 1999-08-13 2002-12-10 Bret Ferree Spinal fusion cage with lordosis correction
US6245107B1 (en) * 1999-05-28 2001-06-12 Bret A. Ferree Methods and apparatus for treating disc herniation
US6419704B1 (en) * 1999-10-08 2002-07-16 Bret Ferree Artificial intervertebral disc replacement methods and apparatus
US6371990B1 (en) * 1999-10-08 2002-04-16 Bret A. Ferree Annulus fibrosis augmentation methods and apparatus
US6283966B1 (en) 1999-07-07 2001-09-04 Sulzer Spine-Tech Inc. Spinal surgery tools and positioning method
NL1012719C1 (en) 1999-07-28 2001-01-30 Veldhuizen Dr Ag Spine prosthesis.
DE19935725C2 (en) 1999-07-29 2003-11-13 Wolf Gmbh Richard Medical instrument, especially a rectoscope
US6719797B1 (en) * 1999-08-13 2004-04-13 Bret A. Ferree Nucleus augmentation with in situ formed hydrogels
US6685695B2 (en) * 1999-08-13 2004-02-03 Bret A. Ferree Method and apparatus for providing nutrition to intervertebral disc tissue
US6793677B2 (en) 1999-08-13 2004-09-21 Bret A. Ferree Method of providing cells and other biologic materials for transplantation
US7220281B2 (en) 1999-08-18 2007-05-22 Intrinsic Therapeutics, Inc. Implant for reinforcing and annulus fibrosis
US6508839B1 (en) * 1999-08-18 2003-01-21 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation
US6425919B1 (en) 1999-08-18 2002-07-30 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation
US6436119B1 (en) 1999-09-30 2002-08-20 Raymedica, Inc. Adjustable surgical dilator
US6432107B1 (en) 2000-01-15 2002-08-13 Bret A. Ferree Enhanced surface area spinal fusion devices
US7052516B2 (en) * 1999-10-20 2006-05-30 Anulex Technologies, Inc. Spinal disc annulus reconstruction method and deformable 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
US6830570B1 (en) 1999-10-21 2004-12-14 Sdgi Holdings, Inc. Devices and techniques for a posterior lateral disc space approach
WO2001028469A2 (en) * 1999-10-21 2001-04-26 Sdgi Holdings, Inc. Devices and techniques for a posterior lateral disc space approach
DE29919914U1 (en) 1999-11-12 2000-01-27 Wolf Gmbh Richard Stricture scalpel
US6395034B1 (en) * 1999-11-24 2002-05-28 Loubert Suddaby Intervertebral disc prosthesis
US7014633B2 (en) * 2000-02-16 2006-03-21 Trans1, Inc. Methods of performing procedures in the spine
US6558390B2 (en) * 2000-02-16 2003-05-06 Axiamed, Inc. Methods and apparatus for performing therapeutic procedures in the spine
US6899716B2 (en) * 2000-02-16 2005-05-31 Trans1, Inc. Method and apparatus for spinal augmentation
US6332894B1 (en) 2000-03-07 2001-12-25 Zimmer, Inc. Polymer filled spinal fusion cage
US6402750B1 (en) * 2000-04-04 2002-06-11 Spinlabs, Llc Devices and methods for the treatment of spinal disorders
US6579291B1 (en) * 2000-10-10 2003-06-17 Spinalabs, Llc Devices and methods for the treatment of spinal disorders
US6689125B1 (en) * 2000-04-04 2004-02-10 Spinalabs, Llc Devices and methods for the treatment of spinal disorders
US6851430B2 (en) * 2000-05-01 2005-02-08 Paul M. Tsou Method and apparatus for endoscopic spinal surgery
US6579318B2 (en) * 2000-06-12 2003-06-17 Ortho Development Corporation Intervertebral spacer
US6921532B1 (en) 2000-06-22 2005-07-26 Spinal Restoration, Inc. Biological Bioadhesive composition and methods of preparation and use
US6500132B1 (en) * 2000-06-30 2002-12-31 Sdgi Holdings, Inc. Device and method for determining parameters of blind voids
US6837892B2 (en) * 2000-07-24 2005-01-04 Mazor Surgical Technologies Ltd. Miniature bone-mounted surgical robot
DE10038480C2 (en) * 2000-08-07 2002-07-18 Wolf Gmbh Richard Milling cutter for tissue
US6824565B2 (en) 2000-09-08 2004-11-30 Nabil L. Muhanna System and methods for inserting a vertebral spacer
US6599291B1 (en) 2000-10-20 2003-07-29 Sdgi Holdings, Inc. Methods and instruments for interbody surgical techniques
ES2358498T3 (en) * 2000-10-24 2011-05-11 Cryolife, Inc. BIOPROSTÉTICO FILLING AND METHODS, PARTICULARLY FOR THE IN SITU TRAINING OF BIOPRÓTESIS OF INTERVERTEBRAL DISCS.
AU2002243270B2 (en) 2000-10-25 2006-03-09 Warsaw Orthopedic, Inc. Vertically expanding intervertebral body fusion device
US6582467B1 (en) * 2000-10-31 2003-06-24 Vertelink Corporation Expandable fusion cage
US6692501B2 (en) * 2000-12-14 2004-02-17 Gary K. Michelson Spinal interspace shaper
NZ525999A (en) * 2000-12-15 2006-05-26 Spineology Inc Annulus-reinforcing band
US6936070B1 (en) 2001-01-17 2005-08-30 Nabil L. Muhanna Intervertebral disc prosthesis and methods of implantation
US6986772B2 (en) * 2001-03-01 2006-01-17 Michelson Gary K Dynamic lordotic guard with movable extensions for creating an implantation space posteriorly in the lumbar spine
US6827743B2 (en) * 2001-02-28 2004-12-07 Sdgi Holdings, Inc. Woven orthopedic implants
US6595998B2 (en) 2001-03-08 2003-07-22 Spinewave, Inc. Tissue distraction device
US6607558B2 (en) 2001-07-03 2003-08-19 Axiomed Spine Corporation Artificial disc
ATE398431T1 (en) * 2001-08-24 2008-07-15 Zimmer Gmbh ARTIFICIAL DISC
US7083639B2 (en) 2001-09-26 2006-08-01 Medtronic Vascular, Inc. Stent delivery catheter with grooved balloon and methods of making same
US6805715B2 (en) 2001-10-09 2004-10-19 Pmt Corporation Method and device for treating intervertebral disc herniations
WO2003037166A2 (en) * 2001-11-01 2003-05-08 Boyd Lawrence M Devices and methods for the restoration of a spinal disc
US7048963B2 (en) * 2001-11-30 2006-05-23 Cambridge Polymers Group, Inc. Layered aligned polymer structures and methods of making same
US6733534B2 (en) * 2002-01-29 2004-05-11 Sdgi Holdings, Inc. System and method for spine spacing
US6736835B2 (en) * 2002-03-21 2004-05-18 Depuy Acromed, Inc. Early intervention spinal treatment methods and devices for use therein
US6726720B2 (en) * 2002-03-27 2004-04-27 Depuy Spine, Inc. Modular disc prosthesis
US7128746B2 (en) 2002-05-16 2006-10-31 Pmt Corporation Device for treating intervertebral disc herniations
AU2002950340A0 (en) 2002-07-23 2002-09-12 Commonwealth Scientific And Industrial Research Organisation Biodegradable polyurethane/urea compositions
WO2004016217A2 (en) 2002-08-15 2004-02-26 David Gerber Controlled artificial intervertebral disc implant
US20040054413A1 (en) * 2002-09-16 2004-03-18 Howmedica Osteonics Corp. Radiovisible hydrogel intervertebral disc nucleus
US7744651B2 (en) * 2002-09-18 2010-06-29 Warsaw Orthopedic, Inc Compositions and methods for treating intervertebral discs with collagen-based materials
US6932843B2 (en) 2002-09-25 2005-08-23 Medicinelodge, Inc. Apparatus and method for the in-situ formation of a structural prosthesis
US7004971B2 (en) * 2002-12-31 2006-02-28 Depuy Acromed, Inc. Annular nucleus pulposus replacement
EP1594421A4 (en) 2003-01-17 2006-02-08 Psinergi Corp Artificial nucleus pulposus and method of injecting same
WO2004082526A2 (en) * 2003-03-14 2004-09-30 Schneiderman Gary A Intervertebral disk nuclear augmentation system
US7060097B2 (en) * 2003-03-31 2006-06-13 Depuy Spine, Inc. Method and apparatus for implant stability
US6969405B2 (en) 2003-04-23 2005-11-29 Loubert Suddaby Inflatable intervertebral disc replacement prosthesis
US20040249459A1 (en) 2003-06-02 2004-12-09 Ferree Bret A. Nucleus replacements with asymmetrical stiffness
US6958077B2 (en) * 2003-07-29 2005-10-25 Loubert Suddaby Inflatable nuclear prosthesis
WO2005034864A2 (en) * 2003-10-08 2005-04-21 University Of North Carolina At Chapel Hill Spine replacement system
TW200533385A (en) 2004-03-03 2005-10-16 Commw Scient Ind Res Org Biocompatible polymer compositions for dual or multi staged curing
US20060135959A1 (en) * 2004-03-22 2006-06-22 Disc Dynamics, Inc. Nuclectomy method and apparatus
US20050209602A1 (en) 2004-03-22 2005-09-22 Disc Dynamics, Inc. Multi-stage biomaterial injection system for spinal implants
WO2005089778A1 (en) * 2004-03-24 2005-09-29 Commonwealth Scientific And Industrial Research Organisation Biodegradable polyurethane and polyurethane ureas
US20050278023A1 (en) 2004-06-10 2005-12-15 Zwirkoski Paul A Method and apparatus for filling a cavity
US20060122704A1 (en) * 2004-07-27 2006-06-08 Synthes Inc. Supplementation or replacement of a nucleus pulposus of an intervertebral disc
US20060095045A1 (en) * 2004-11-01 2006-05-04 Sdgi Holdings, Inc. Methods for explantation of intervertebral disc implants
WO2006060482A2 (en) 2004-12-01 2006-06-08 The Regents Of The University Of California Systems, devices and methods of treatment of intervertebral disorders
US20060265077A1 (en) 2005-02-23 2006-11-23 Zwirkoski Paul A Spinal repair
US20060253198A1 (en) 2005-05-03 2006-11-09 Disc Dynamics, Inc. Multi-lumen mold for intervertebral prosthesis and method of using same
US20060253199A1 (en) 2005-05-03 2006-11-09 Disc Dynamics, Inc. Lordosis creating nucleus replacement method and apparatus
US7601172B2 (en) 2005-06-15 2009-10-13 Ouroboros Medical, Inc. 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
US7618457B2 (en) * 2005-08-10 2009-11-17 Zimmer Spine, Inc. Devices and methods for disc nucleus replacement
US20070093906A1 (en) * 2005-10-26 2007-04-26 Zimmer Spine, Inc. Nucleus implant and method
US7699894B2 (en) 2005-12-22 2010-04-20 Depuy Spine, Inc. Nucleus pulposus trial device and technique
US7645301B2 (en) * 2006-01-13 2010-01-12 Zimmer Spine, Inc. Devices and methods for disc replacement
US20070168041A1 (en) 2006-01-17 2007-07-19 Sudhakar Kadiyala Method and instruments for intervertebral disc augmentation through a pedicular approach

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070276491A1 (en) * 2006-05-24 2007-11-29 Disc Dynamics, Inc. Mold assembly for intervertebral prosthesis

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010080337A1 (en) * 2008-12-18 2010-07-15 Disc Dynamics, Inc. Inflatable mold for maintaining posterior spinal elements in a desired alignment

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