WO1998022050A1 - Intervertebral prosthetic device - Google Patents
Intervertebral prosthetic device Download PDFInfo
- Publication number
- WO1998022050A1 WO1998022050A1 PCT/US1997/019610 US9719610W WO9822050A1 WO 1998022050 A1 WO1998022050 A1 WO 1998022050A1 US 9719610 W US9719610 W US 9719610W WO 9822050 A1 WO9822050 A1 WO 9822050A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthetic device
- fixation
- fixation member
- compressible
- adjustable
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/025—Joint distractors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/025—Joint distractors
- A61B2017/0256—Joint distractors for the spine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30721—Accessories
- A61F2/30749—Fixation appliances for connecting prostheses to the body
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30224—Three-dimensional shapes cylindrical
- A61F2002/30225—Flat cylinders, i.e. discs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30224—Three-dimensional shapes cylindrical
- A61F2002/3023—Three-dimensional shapes cylindrical wedge-shaped cylinders
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30324—The prosthesis having different structural features at different locations within the same prosthesis differing in thickness
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30327—The prosthesis having different structural features at different locations within the same prosthesis differing in diameter
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters 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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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
- A61F2002/30354—Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
- A61F2002/30362—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit with possibility of relative movement between the protrusion and the recess
- A61F2002/3037—Translation along the common longitudinal axis, e.g. piston
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- A61F2/00—Filters 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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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2/00—Filters 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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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
- A61F2002/3055—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting length
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- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30563—Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
- A61F2310/00239—Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
Definitions
- This invention relates to a novel intervertebral prosthetic device. More particularly, this invention relates to an intervertebral prosthetic device that can be implanted to replace a damaged intervertebral disc.
- the human spine is a flexible structure comprised of thirty-three vertebrae. Intervertebral discs separate and cushion adjacent vertebrae. The intervertebral discs act as shock absorbers and allow bending between the vertebrae.
- An intervertebral disc comprises two major components: the nucleus pulposus and the annulus fibrosis.
- the nucleus pulposus is centrally located in the disc and occupies 25-40% of the disc's total cross- sectional area.
- the nucleus pulposus usually contains 70-90% water by weight and mechanically functions like an incompressible hydrostatic material.
- the annulus fibrosis surrounds the nucleus pulposus and resists torsional and bending forces applied to the disc.
- the annulus fibrosis thus serves as the disc's main stabilizing structure.
- Vertebral end-plates separate the disc from the vertebral bodies on either side of the disc. Individuals with damaged or degenerated discs often experience significant pain. The pain results in part from instability in the intervertebral joint due to a loss of hydrostatic pressure in the nucleus pulposus. Loss of hydrostatic pressure leads to a loss of disc height.
- a conventional treatment for degenerative disc disease is spinal fusion.
- a surgeon removes the damaged natural disc and then fuses the two adjacent vertebral bones into one piece.
- the surgeon fuses the vertebral bones by grafting bone between the adjacent vertebrae and sometimes uses metal rods, cages, or screws to hold the graft in place until the graft heals.
- Other fusion procedures do not require surgical removal of the disc.
- spinal fusion may alleviate pain associated with degenerative disc disease, it also results in loss of motion at the fused vertebral joint. Lack of motion at the fused site puts additional pressure on the discs above and below the fusion, sometimes causing them to degenerate and produce pain.
- prosthetic devices were developed to replace the damaged disc with a suitable bio echanical equivalent.
- U.S. Patent No. 4,759,769 to Hed an et . al . discloses a synthetic disc having upper and lower plates hinged together. Although the hinged disc allows forward bending between adjacent vertebrae, the hinged disc does not allow axial compression or lateral flexion. Nor does it allow axial rotation of the vertebral column at the site of the implant. Therefore, the Hedman et. al . device lacks the biomechanics of a natural disc.
- the prosthetic disc device disclosed in U.S. Patent No. 4,309,777 to Patil does not replicate natural motion between adjacent discs.
- the Patil device includes two cups, one overlapping the other and spaced from the other by springs. The cups move only in a single axial dimension.
- the Patil device thus does not enable natural flexion of the spine in any direction.
- the highly constrained motion of the Patil device can lead to high device/tissue interface stresses and implant loosening.
- Many synthetic disc devices connect to the vertebral bodies by conventional mechanical attachments, such as pegs or screws, which are known to loosen under cyclic loading conditions.
- Other synthetic disc devices use plastic or elastomeric components which, over a lifetime, produce debris from wear and possible unknown side effects.
- an intervertebral prosthetic device having a first fixation member, a second fixation member, and a compressible member disposed between them.
- the first fixation member is implanted within a first vertebral body
- the second fixation member is implanted within a second vertebral body adjacent the first vertebral body.
- the first fixation member generally comprises an adjustable member and a support member.
- the adjustable member preferably has a first plate, a second plate, and at least one adjustment element that extends between the two plates and enables adjustment of the height of the adjustable member along its longitudinal axis.
- the first plate is operably positioned against subchondral bone of a distant end-plate of the first vertebral body
- the second plate is operably positioned against the support member.
- the second fixation member may include both a support member and an adjustable member or, in an alternative embodiment, may include only a support member.
- the adjustable member is structurally similar to the adjustable member of the first fixation member and includes a first plate for positioning against subchondral bone of a distant end- plate of the second vertebral body, a second plate for positioning against the support member, and at least one adjustment element extending between the two plates.
- the support member is operably positioned against a near end-plate of the second vertebral body.
- the first fixation member may comprise only a support member, depending on the patient's needs.
- the support members are modular.
- the support members are generally wedge-shaped and may be made in difference sizes to accommodate the angle between adjacent vertebrae at a specific vertebral level. The angle between adjacent vertebrae typically ranges between 3-10 degrees, and, thus the angle created by opposing surfaces of the wedge-shaped support member falls within that same range.
- the compressible member has an outer periphery less than or substantially equal to the diameter of the nucleus pulposus of the operative intervertebral disc.
- the compressible member is sized to replace the nucleus pulposus of an intervertebral disc and essentially to fit within the annulus fibrosis of the intervertebral disc.
- the compressible member comprises at least one spring that can be pre-stressed or pre-loaded to place the annulus fibrosis under tension and to reproduce the mechanical properties of a natural disc. Maintaining the annulus fibrosis under tension results in an artificial intervertebral joint that is stable.
- the fixation members include a porous surface suitable for bone ingrowth so that the fixation members fuse to the vertebrae without requiring conventional mechanical attachments.
- Figure 1 is a schematic, cut-away, side view of an intervertebral prosthetic device implanted in a spine in accordance with a preferred embodiment of the invention
- Figure 2 is a top perspective view of a compressible member of the subject intervertebral prosthetic device
- Figures 3A-3C are top perspective views of different embodiments of a spring of the compressible member of the subject intervertebral prosthetic device
- Figure 4 is a top perspective, partially exploded view of a fixation member of the subject intervertebral prosthetic device and shows an adjustable member and a support member;
- Figure 5 is a top view of a second plate of the adjustable member
- Figure 6 is a side view, in cross-section, of the support member;
- Figure 7 is a schematic, cut-away, side view of an intervertebral prosthetic device implanted in a spine in accordance with another preferred embodiment of the invention;
- Figure 8 is a schematic, cut-away, side view showing subchondral bones of a superior vertebral body after a partial vertebrectomy;
- Figure 9 is a sectional view of a vertebrae after a partial vertebrectomy, as taken along line 9-9 of Figure 8;
- Figure 10 is a schematic, cut-away, side view of a vertebral joint area after a partial vertebrectomy and excision of a nucleus pulposus of a natural disc;
- Figure 11 is a schematic, cut-away, side view of a vertebral joint and shows a fixation member, including an adjustable member and a support member, implanted in an inferior vertebral body;
- Figure 12 is a schematic, cut-away, side view of a vertebral joint and shows a compressible member implanted in an intervertebral joint;
- Figure 13 is a schematic, cut-away, side view of a vertebral joint and shows a technique for adjusting the height of an adjustable member implanted in a superior vertebral body
- Figure 14 is a schematic, cut-away, side view of a vertebral joint and shows a technique for bone grafting an adjustable member in a superior vertebral body.
- intervertebral prosthetic device implanted in a spine 12 in accordance with a preferred embodiment of the present invention.
- the intervertebral prosthetic device 10 is designed to replace a damaged natural disc.
- the intervertebral prosthetic device 10 has a first fixation member 14, a second fixation member 16, and a compressible member 18 that is positioned between the first fixation member 14 and the second ixation member 16.
- the first fixation member 14 is positioned in a first vertebral body 20, and the second fixation member 16 is positioned within a second vertebral body 22 adjacent the first vertebral body 20.
- Each fixation member 14 and 16 has an adjustable member 28 and 30, respectively, and a support member 32 and 34, respectively.
- Each fixation member also has a bone- contacting surface, preferably porous, for positioning against subchondral bone of an associated vertebral body.
- a bone-contacting surface 27 of the adjustable member 28 is positioned against the subchondral bone of an end-plate 36 of the superior vertebral body 20
- a bone-contacting surface 29 of the adjustable member 30 is positioned against the subchondral bone of an end-plate 38 of the inferior vertebral body 22.
- the present intervertebral prosthetic device does not require conventional mechanical attachments, such as pegs or screws, to hold the prosthetic device in place.
- the intravertebral (i.e., within a vertebral body) positioning of the fixation members maintains the prosthetic device in stable relationship at the operative intervertebral joint.
- the adjustable member 28 of the first fixation member 14 has an imaginary first longitudinal axis, shown by dashed line A-A, and adjustment elements 24 that allow adjustment of the height of the adjustable member 28 substantially along its longitudinal axis A-A.
- the second fixation member 16 is structurally similar to the first fixation member 14, but inverted.
- the adjustable member 30 of the second fixation member 16 has a second longitudinal axis, shown by dashed line B-B, and adjustment elements 26 that allow adjustment of the height of the adjustable member 30 substantially along its longitudinal axis B-B.
- the compressible member 18 comprises at least one spring and, in a preferred embodiment, comprises a plurality of springs 40.
- the compressible member may comprise other suitable configurations.
- the compressible member may comprise a monolithic body made of an biocompatible material compressible in an axial direction, that is, a direction substantially parallel to the spine.
- the compressible member 18 is implanted in the region of an excavated nucleus pulposus of the operative intervertebral disc.
- the compressible member 18 is dimensioned so that the annulus fibrosis of the natural disc is maintained.
- the present intervertebral prosthetic device restores the mechanical properties of the nucleus pulposus without disrupting the annulus fibrosis. Retention of the annulus fibrosis maintains stability of the intervertebral joint at the implant site.
- the annulus fibrosis serves as a boundary for the compressible member and minimizes accidental dislodgement of the prosthetic device.
- the intervertebral prosthetic device 10 permits at least four degrees of relative motion between the first vertebral body 20 and the second vertebral body 22. These degrees of relative motion include sagittal bending, coronal bending, axial rotation, and axial compression. Moreover, the compressible member permits small increments of translational movement between the vertebral bodies (i.e. , fifth and sixth degrees of relative motion, namely anterior-posterior translation and side-to-side, or lateral, translation) .
- the compressible member 18 has a top plate 42, a bottom plate 44, and a plurality of coil springs 40 extending between the top plate 42 and the bottom plate 44.
- the top plate 42 has a first surface 46, which is connectable to the first fixation member 14, and a second surface 48.
- the bottom plate 44 also has a first surface 50, which is connectable to the second fixation member 16, and a second surface 52.
- the springs 40 extend between the second surfaces 48 and 52.
- the compressible member 18 When pre-loaded, as will be explained in more detail below, the compressible member 18 preferably has an axial height of approximately 1.5 cm, greatest at the L45 vertebral level and slightly less at the upper lumbar vertebrae.
- the coil springs 40 are preferably designed to have non-linear stiffness so that they become stiffer at higher applied loads. The nonlinear stiffness simulates physiological intervertebral stiffness.
- the compressible member 18 may comprise a plurality of springs extending between, and directly connected to, support members 32 and 34.
- the compressible member 18 may comprise a single spring with a relatively large coil diameter (not shown) extending between, and directly connected to, the support members 32 and 34. Any spring arrangement may be utilized that achieves sufficient axial compressive force to replicate the biomechanics of the natural disc.
- the compressible member includes an imaginary longitudinal axis, shown by the dashed line
- a largest dimension of the compressible member's outer periphery is less than or substantially equal to the diameter of a nucleus pulposus of the natural intervertebral disc.
- the annulus fibrosis of the natural disc which is substantially preserved in the -II- implantation procedure, circumscribes the compressible member 18.
- the compressible member comprises a plurality of springs
- the outer periphery of the compressible member circumscribes the springs, and the largest dimension of that outer periphery may extend to, but does not extend beyond, the nucleus pulposus.
- the outer periphery equals the larger of the two plate peripheries.
- the outer periphery of the compressible member preferably ranges between 2.0 cm to 3.0 cm, which approximates the diameter of the nucleus pulposus of a natural intervertebral disc.
- Figures 3A-3C show three embodiments of a coil spring designed to possess non-linear stiffness.
- the coil spring 54 has a variable, or non-uniform, cross-sectional diameter 56.
- Figure 3B shows another embodiment in which a coil spring 58 has a variable pitch 60, where the pitch is defined as the distance between successive coils of the spring 58.
- Figure 3C shows a third embodiment of a coil spring 62 in which at least two of the spring coils have different radii 64 measured from an imaginary axis D-D extending along the central axis of the spring 62.
- FIG 4 shows a preferred embodiment of the first fixation member 14.
- the second fixation member 16 is structurally similar to the first fixation member 14, but inverted. The following discussion thus also applies to the second fixation member 16.
- the fixation member 14 comprises an adjustable member, generally indicated 28, and a support member 32.
- the adjustable member 28 is adjustable in an axial direction by adjustment elements 24.
- the adjustment elements 24 preferably comprise telescopic struts extending between a first plate 31 and a second plate 33.
- the first plate 31 has a bone-contacting surface, such as 27 shown in an operative context in Figure 1, and the second plate has a surface 35 for positioning against the support member 32.
- the illustrative embodiment shows flat plates 31 and 33, it will be understood by those skilled in the art that these structures need not be flat and may, for example, have undulating surfaces.
- the bone-contacting surface 27 of the first plate 31 is concave to match the contour of the subchondral bone of the associated vertebral body.
- the adjustment elements 24 adjust the distance between the first bone-contacting plate 31 and the second plate 33, thus adjusting the height of the adjustable member 28.
- a surgeon may adjust the telescopic struts to increase the height of the adjustable member and thus pre-load the compressible member to mechanically reproduce the axial compression absorbed by a nucleus pulposus of a natural disc.
- Pre-loading the compressible member restores the intervertebral height at the operative joint and restores the function of the annulus fibrosis.
- the annulus fibrosis load shares with the compressible member which reduces implant/tissue interface stresses.
- Each telescopic strut is provided with a lock screw 63 to adjust the length of the strut 24 and hence control the height of the adjustable member.
- the lock screw 63 may comprise, for example, a pin (not shown) that extends through both the telescoping portion 65 and the housing portion 67 of the strut 24.
- Each strut 24 is independently adjustable.
- Figure 5 shows a top view of the second plate 33 of the adjustable member 28.
- the adjustment elements 24 preferably are spaced equidistant from each other to enable specific height adjustment of various regions of the adjustable member.
- a key feature of the present invention is that controlling the height of the adjustable members 28 and 30, along with selecting an appropriately-sized support member, controls the "disc" height.
- the disc height is defined as the axial distance between the vertebrae above and below the operative disc.
- the compressible member 18 acts as a shock absorber to minimize impact loading and, thus, minimize device failure or vertebral fracture.
- the first and second fixation members 14 and 16 have porous portions, such as the bone-contacting surface 27, to permit bone ingrowth.
- a biocompatible fabric or suitable material may be wrapped around the fixation members to enable bone ingrowth.
- the present prosthetic device does not require conventional mechanical attachments, such as pegs or screws, to hold the prosthesis permanently in place.
- the present prosthetic device may include mechanical or other attachments to supplement the porous portions of the fixation members and to temporarily fix the prosthetic device in place until bone ingrowth has occurred.
- the adjustment elements 24 may include fins 66 extending outward from an exterior surface of the element 24, as shown in Figure 4.
- the fins 66 increase the surface area of the fixation member 14 to which bone may attach.
- these fins 66 are located on the adjustment elements that are positioned on the anterior side of the adjustable member 28.
- the present prosthetic device also may include protuberances (not shown) on the bone-contacting surface of the adjustable members to increase the surface area of the porous portion of the fixation members and, thus, encourage bone ingrowth.
- Figure 6 shows a cross-section of support member 32.
- the support member 32 has a first surface 72 that operably faces away from the compressible member 18 and a second surface 74 that operably faces towards the compressible member 18.
- the first and second surfaces 72 and 74 are oblique so that a circumferential surface 77 around the support member 32 varies in width, as shown in Figure 4.
- the support member 32 thus is wedge-shaped.
- the support member 32 preferably tapers from a maximum thickness at one side 73 to a minimum thickness at an opposite side 75.
- the support member 32 is thicker on the side of the fixation member 14 placed anteriorly in a patient's spine to account for the spine's natural curvature.
- the support members are constructed with various thicknesses and with various angled surfaces, depending upon the vertebral level of the operative intervertebral joint.
- An angle ⁇ shown in Figure 6 ranges between 3-10 degrees.
- the support members are shaped to maintain sagittal alignment. Maintaining sagittal alignment avoids nonuniform loading of the compressible member and avoids early fatigue failure of that member.
- Figure 7 shows another embodiment of the present intervertebral prosthetic device, generally indicated 76, which comprises a first fixation member 78, a second fixation member 80, and a compressible member 82.
- the compressible member 82 is positioned between the first and second fixation members 78 and 80.
- the second fixation member comprises a wedge-shaped support member with an upper surface 84 that attaches to the compressible member 82 and a lower surface 86 that rests upon subchondral bone of a near end-plate 88 of an inferior vertebral body.
- adjustment of the first fixation member 78 pre-loads the compressible member 82 to an appropriate extent.
- This embodiment is particularly suited for young patients.
- a lower surface 86 of the support member 80 has a slightly convex shape to match the natural contour of the near end-plate of the inferior vertebral body.
- the surface 86 is preferably composed of a porous material.
- the present intervertebral prosthetic device has a modular design so that the prosthesis may be sized to the patient's anatomy and designed for the patient's condition.
- the modular design also enables replacement of individual components of the prosthesis (i.e., an adjustable member, a support member, or a compressible member) , rather than replacement of the entire prosthesis should one component fail.
- the compressible member is preferably attached to the fixation members by mechanical attachments, such screws, rather than bone cement so that a surgeon may easily replace damaged or worn components.
- the present prosthetic device has no ball bearings, rollers, or hinges, it produces little wear debris.
- the present prosthetic device need not include plastic polymers or elastomeric components, the present prosthetic device does not degrade under long-term cyclic loading conditions.
- the present prosthetic device comprises biocompatible metallic materials, preferably a titanium alloy having, for example, 4% vanadium and 6% aluminum. Persons of skill in the art will recognize other suitable materials, for example, a cobalt-chromium alloy, such as alloy number 301.
- the present prosthetic device with the exception of the springs of the compressible member, may comprise a ceramic material, such as aluminium oxide and zirconium oxide.
- the porous surfaces of the bone-contacting member and support member may be coated with hydroxyapatite or bioactive proteins (e.g., bone morphogenic protein) to encourage bone ingrowth.
- FIG 8 shows a pathological intervertebral disc 90 located between a superior vertebral body 92 and an inferior vertebral body 94.
- a surgeon Prior to implantation, a surgeon performs a partial vertebrectomy to excise bone matter from the superior vertebral body 92 for receipt of a fixation member.
- the partial vertebrectomy creates a cavity bounded by subchondral bone of a distant end-plate 96 and subchondral bone of a near end-plate 98 of the superior vertebral body 92.
- Figure 9 shows a cross- sectional view of the superior vertebral body 92 after the partial vertebrectomy, as taken along line 9-9 in Figure 8.
- the surgeon next excises the nucleus pulposus of the damaged disc to create a cavity 100, as shown in Figure 10, for receipt of the compressible member.
- the annulus fibrosis 102 seen in Figure 11, is maintained.
- the surgeon may perform a partial vertebrectomy on the inferior vertebral body or may excise cartilage matter only to the near end-plate, depending upon whether the surgeon implants the embodiment shown in Figure 1 or the embodiment shown in Figure 7, respectively.
- the following description details implantation of the prosthesis shown in Figure 1; however, one of skill in the art would understand how to modify the procedure described below to implant the prosthesis of Figure 7.
- the surgeon implants a fixation member 104 into the inferior vertebral body 94, as shown in Figure 11.
- the surgeon selects a support member with an appropriate thickness to accommodate the angulation at the operative intervertebral levels.
- the surgeon then inserts a compressible member 106 into the cavity formerly containing the nucleus pulposus of the damaged disc and connects it to the fixation member 104, as shown in Figure 12.
- the compressible member 106 and the fixation member 104 may be connected by conventional attachment members, such as screws, or by biocompatible cement or a suitable adhesive composition.
- each adjustable member one at a time, by placing a spreader device with a calibrated tensiometer between the first and second plates of the adjustable member.
- the surgeon applies distraction until the adjustable member is seated against the subchondral bone of the vertebral body and until the desired compression has been applied to the compressible member.
- the adjustment elements of the adjustable member are then secured.
- Figure 13 shows rotation of the lock screws 112 of individual telescopic struts 108 to secure the struts at an appropriate height.
- the surgeon next packs cancellous bone grafts 118 around the struts of each adjustable member, as shown in Figure 14.
- the growth of bone around the fixation member and into its porous surfaces secures the intervertebral prosthetic device in place, absent mechanical attachments typically used in conventional disc prostheses.
- the surgeon then replaces the cortical bone from the partial vertebrectomy procedure and secures it with a bone screw or bone cement.
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
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BR9714357A BR9714357A (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthesis device |
AU51542/98A AU719735B2 (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthetic device |
JP52366698A JP3677050B2 (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthesis |
DE69722244T DE69722244T2 (en) | 1996-11-22 | 1997-11-06 | INTERVERTEBRAL PROSTHESIS-RELATED |
CA002271800A CA2271800C (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthetic device |
EP97946354A EP0948299B1 (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthetic device |
AT97946354T ATE240702T1 (en) | 1996-11-22 | 1997-11-06 | INTERVERTEBRATE PROSTHETIC CONNECTION |
DK97946354T DK0948299T3 (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthetic device |
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US08/753,334 | 1996-11-22 | ||
US08/753,334 US5827328A (en) | 1996-11-22 | 1996-11-22 | Intervertebral prosthetic device |
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WO1998022050A1 true WO1998022050A1 (en) | 1998-05-28 |
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PCT/US1997/019610 WO1998022050A1 (en) | 1996-11-22 | 1997-11-06 | Intervertebral prosthetic device |
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US (1) | US5827328A (en) |
EP (2) | EP1342456B1 (en) |
JP (1) | JP3677050B2 (en) |
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AT (2) | ATE240702T1 (en) |
AU (1) | AU719735B2 (en) |
BR (1) | BR9714357A (en) |
CA (1) | CA2271800C (en) |
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WO (1) | WO1998022050A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
EP0948299A1 (en) | 1999-10-13 |
KR20000069084A (en) | 2000-11-25 |
DE69722244T2 (en) | 2003-12-11 |
EP1342456A1 (en) | 2003-09-10 |
AU719735B2 (en) | 2000-05-18 |
US5827328A (en) | 1998-10-27 |
DE69733850T2 (en) | 2006-05-24 |
KR100394937B1 (en) | 2003-08-19 |
EP0948299B1 (en) | 2003-05-21 |
CA2271800A1 (en) | 1998-05-28 |
DE69722244D1 (en) | 2003-06-26 |
CA2271800C (en) | 2005-01-18 |
JP2001504369A (en) | 2001-04-03 |
DE69733850D1 (en) | 2005-09-01 |
DK0948299T3 (en) | 2003-06-23 |
JP3677050B2 (en) | 2005-07-27 |
ATE240702T1 (en) | 2003-06-15 |
EP1342456B1 (en) | 2005-07-27 |
ATE300257T1 (en) | 2005-08-15 |
AU5154298A (en) | 1998-06-10 |
BR9714357A (en) | 2000-03-21 |
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