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WO2014124453A2 - Implant de disque vertébral unitaire - Google Patents

Implant de disque vertébral unitaire Download PDF

Info

Publication number
WO2014124453A2
WO2014124453A2 PCT/US2014/015850 US2014015850W WO2014124453A2 WO 2014124453 A2 WO2014124453 A2 WO 2014124453A2 US 2014015850 W US2014015850 W US 2014015850W WO 2014124453 A2 WO2014124453 A2 WO 2014124453A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
protrusion
bearing surface
bearing
endcap
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2014/015850
Other languages
English (en)
Other versions
WO2014124453A3 (fr
Inventor
Brian Burkinshaw
Jonathan Stupka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2014124453A2 publication Critical patent/WO2014124453A2/fr
Publication of WO2014124453A3 publication Critical patent/WO2014124453A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • 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
    • 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
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/3021—Three-dimensional shapes conical frustoconical
    • 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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    • A61F2002/30108—Shapes
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    • A61F2002/30224—Three-dimensional shapes cylindrical
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30225—Flat cylinders, i.e. discs
    • A61F2002/30227—Flat cylinders, i.e. discs arched, domed or vaulted
    • 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
    • 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
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • 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
    • 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
    • A61F2002/30448—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • 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
    • A61F2002/30535—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
    • 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
    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
    • 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
    • A61F2002/30769—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth madreporic
    • 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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    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue

Definitions

  • a unitary intervertebral device having no independent moving components is provided for non- fusion articulation applications.
  • the interbody articulating device allows for limited flexion and rotation between adjacent vertebrae, helping to preserve or restore near-normal motion between adjacent vertebrae. Rotational motion is achieved around one or more protrusions incorporated into the spinal interbody device.
  • the invention is an implant comprising a unitary structure, having no
  • independent articulating components containing integrated features to replace the articulating function of the natural spinal disc, and allowing a spinal joint into which it has been implanted, to closely approximate the flexion biomechanics and rotational motion of a reasonably healthy joint.
  • a first protrusion extends perpendicularly from the superior (first) aspect of a discus-shape of the interbody device to form a spike or rotational protrusion
  • a second protrusion extends axially from the inferior (second) aspect of the interbody device to form a second spike or rotational protrusion.
  • Protrusions preferably extend perpendicularly from the apex of both the first and second arcuate articulating surfaces about the central axis.
  • a single protrusion extends axially from the superior aspect of the interbody device to form a spike, pivot point, or anchoring protrusion, while the inferior surface is a slightly rounded articulating bearing surface.
  • One or both of the first and / or second arcuate surfaces may be highly polished.
  • the implant is configured to provide a polished articulating surface on one bearing surface and a fusion surface on the opposite bearing surface.
  • tether features are described for providing ingrowth through the endplate to an adjacent vertebral body.
  • fusion salvage devices comprising protrusions, tether features, ingrowth features and surface geometries.
  • a unitary implant adapted for placement between adjacent surfaces of a joint comprising: a first bearing surface and a second bearing surface, wherein the first and second bearing surfaces are generally convex and configured to have generally spherical bearing surface curvature that generally conforms to the concave geometry of the adjacent joint surfaces; an outer radial edge surface; a first protrusion on the first bearing surface, wherein the first protrusion is configured to contact a central portion of a first adjacent joint surface, and wherein the first protrusion is adapted to allow rotation about an axis.
  • the unitary implant further comprises a second protrusion on the
  • the second protrusion is configured to contact a central portion of a second adjacent surface, and wherein the second protrusion is adapted to allow rotation about the common axis of the first and second protrusion.
  • the first protrusion is conical.
  • the second protrusion is conical.
  • the first protrusion or second protrusion may comprise a cone, a curved cone (sometimes referred to as parabolic or hyperbolic cones), a truncated cone, or a cylinder.
  • the protrusions are different.
  • the first protrusion or second protrusion may comprise a truncated cone with a hole about the central axis, or a cylinder with a hole about the central axis.
  • the hole in the protrusion may be a blind hole or a thru-hole that penetrates through the entire implant.
  • the implant comprises a truncated cone with a hole about the central axis, or a cylinder with a hole about the central axis, wherein the implant also comprises a tethering feature that is configured to promote ingrowth or attachment to the adjacent vertebra.
  • the attachment may be to just one adjacent endplate or vertebra: In other
  • the attachment may be to both of the adjacent endplates or vertebrae.
  • the first protrusion and/or the second protrusion is adapted to
  • first protrusion or the second protrusion is adapted to penetrate the endplate of the first adjacent joint surface or the second adjacent joint surface.
  • the implant may further comprise at least a second and third protrusion on the second bearing surface, wherein the at least second and third protrusion are configured to contact a portion of a second adjacent surface, preferably penetrating at least a portion of the adjacent endplate, and wherein the at least second and third protrusion are adapted to prevent movement between the second bearing surface and the second adjacent surface.
  • the implant is generally circular in shape about a central axis. In other embodiments, the implant is non-circular in shape about a central axis. In certain preferred embodiments, the implant may comprises an elliptical planar shape or a common variant thereof.
  • the implant shape may resemble a Reuleaux polygon planar shape comprising three or more sides.
  • the Reuleaux polygon shape may be in the form of an irregular Reuleaux polygon, wherein at least one side of the polygon is curved, or wherein at least one side has a different length than the remaining sides, or both.
  • the implant comprises an anatomic-like bearing surface, wherein the curvature of the first bearing surface and the second bearing surface is generally spherical or near spherical. In other embodiments, the curvature of the first bearing surface and the second bearing
  • first bearing surface and the second bearing surface geometries are the same.
  • first bearing surface and the second bearing surface comprise different geometries.
  • first bearing surface and the second bearing surface are mirrored, or symmetrical about a central transverse plane, whereas in other embodiments the first bearing surface and the second bearing surface are inclined to each other about a central transverse plane to better match or reconstruct the natural lordosis (or kyphosis) of the spine.
  • first bearing surface and the first protrusion are polished articulating surfaces.
  • second bearing surface and the second protrusion are polished articulating surfaces.
  • all of the bearing surfaces and protrusions are polished articulating surfaces.
  • the first bearing surface or second bearing surface may comprise or be manufactured from at least one of the following materials: pyro lytic carbon, titanium, titanium nitride, tantalum, cobalt, chromium, polyethylene, PEEK® (Polyether ether ketone), Delrin®, alumina, zirconia, silicon carbide, silicon nitride, stainless steel, diamond, or a diamond like material.
  • the unitary implant may comprise a core fabricated from one material having one set of properties, and an outer bearing surface fabricated from another material having a different set of properties.
  • the implant is an articulating implant, having applications in artificial limbs, robotics, or other joints and mechanisms.
  • the implant is a medical implant having applications for veterinary applications.
  • the implant is a human medical implant intended for the spine.
  • a unitary spinal disc implant adapted for placement between adjacent vertebral surfaces of a spinal joint comprising: a first bearing surface and a second bearing surface, wherein the first and second bearing surfaces are generally convex and configured to have a spherical curvature that generally conforms to the concave geometry of the adjacent spinal joint surfaces; an outer radial edge surface; a first protrusion on the first bearing surface, wherein the first protrusion is configured to contact a central portion of a first adjacent spinal joint surface, a second protrusion on the second bearing surface, wherein the second protrusion is configured to contact a central portion of a second adjacent spinal surface, wherein the first protrusion and second protrusion are adapted to allow rotation about a common axis.
  • a method of using a spinal disc implant comprising providing a unitary disc implant adapted for placement between adjacent vertebral surfaces of a
  • the implant comprises: a first bearing surface and a second bearing surface, wherein the first bearing surface and second bearing surface are generally spherical; a first protrusion on the first bearing surface, wherein the first protrusion is configured to contact a central portion of a first adjacent spinal joint surface; a second protrusion on the second bearing surface, wherein the second protrusion is configured to contact a central portion of a second adjacent spinal surface; and wherein the first protrusion and second protrusion are adapted to allow rotation of the spinal disc implant about a common axis.
  • a unitary spinal disc implant adapted for placement between adjacent
  • vertebral endplates comprising: a first bearing surface and an second bearing surface, wherein the first and second bearing surfaces are configured to have a geometry that conforms to the concave geometry of adjacent endplate surfaces; at least one conic protrusion on at least one bearing surface for penetrating at least one of the adjacent endplates, wherein the at least one protrusion is configured to contact a central portion of at least one adjacent vertebral endplate.
  • the first bearing surface is an articulating surface.
  • the second bearing surface is an articulating surface.
  • the first bearing surface and second bearing surface geometries are the same.
  • the first bearing surface and second bearing surface comprise different geometries.
  • the first bearing surface may be generally spherical.
  • the first bearing surface geometry may be generally flat to spherical.
  • the second bearing surface geometry is generally flat in the center, transitioning to spherical at the radial edges.
  • the second bearing surface geometry may be generally flat with radiused edges.
  • the second bearing surface geometry may be generally flat and transitioning to a proportionately large spherical radius to replicate a worn or surgically prepared endplate surface.
  • the first bearing surface and second bearing surface comprise slightly increasing arcuate radii of curvature from the outer [radial] edge surface to the central axis.
  • the arcuate radii of curvature of the first and second bearing surfaces are essentially mirror imaged about a central transverse plane.
  • the first bearing surface and second bearing surface are centered about a central axis. Further still, the at least one conic protrusion is centered about the central axis. In other embodiments, the at least one conic protrusion is located off-center from the central axis.
  • first bearing surface and second bearing surface are inclined to each other about a central transverse plane, in order to provide the ability to restore the natural spinal lordotic or kyphotic curvature, wherein the anterior height of the implant may be greater than
  • the posterior height (for restoring lordosis) or the posterior height of the implant may be greater than the anterior height (for restoring kyphosis).
  • the implant is circular in shape about the central axis.
  • the implant is configured to be elliptical in shape about the central axis, wherein the M/L dimension is greater than the A/P dimension.
  • the implant may be polygon in shape about the central axis, wherein the polygon comprises at least four side edges. Additionally, the polygon may have either straight or curved sides, (alternately called a Reuleaux polygon), and may also have sides with different lengths and smoothly blended intersections.
  • the implant comprises an anterior-posterior (front to
  • This dimensional configuration can be provided in a range and may be represented by a ratio wherein the anterior- posterior dimension to the overall arcuate height is at least 1.01 : 1; is at least 1.1 : 1; is at least 1.2: 1; is at least 1.5: 1, or is at least 2.0: 1; etc., for non-limiting example.
  • the implant comprises a medial-lateral dimension that is greater than the overall arcuate height of the implant.
  • This dimensional configuration can also be provided in a range and may be represented by a ratio wherein the medial-lateral dimension to the overall arcuate height is at least 1.01 : 1; is at least 1.1 : 1; is at least 1.2: 1; is at least 1.5: 1, or is at least 2.0:1; is at least 3.0: 1; is at least 4.0: 1; etc., for non-limiting example.
  • the implant comprises at least two protrusions. In other embodiments, the implant comprises exactly two protrusions. In still other embodiments, the implant comprises at least one protrusion on at least one bearing surface, wherein the at least one protrusion is conic. Still further, in some embodiments, the at least one conic protrusion is a truncated cone comprising a base diameter with a wider girth and may further comprise an inner void. In those embodiments where the conic protrusion includes an inner void, the void may be a blind hole, or it may be a void that extends through the entire implant. In preferred embodiments the conic protrusions, and corresponding holes or voids are concentric about a central axis.
  • the at least one protrusion is configured to puncture the adjacent endplate when the implant is positioned between vertebrae.
  • At least one of the first bearing surface and the second bearing surface comprises at least one fenestration.
  • the at least one fenestration may be circular or non-circular in profile, and/or a blind void or hole.
  • the fenestration may comprise a ridge or a groove. Alternatively, more than one fenestration may be present, with each having a different configuration.
  • At least one of the first bearing surface and the second bearing surface is polished, wherein the at least one polished bearing surface has a surface finish ⁇ 4
  • the at least one of the first bearing surface and the second bearing surface is an articulating surface.
  • exactly one of the surfaces is an articulating surface and at least a portion of the other of the surfaces is a textured surface. In some embodiments, at least a portion of at least one of the first surface and the second surface is textured.
  • both the first surface and the second surface is textured.
  • both the first surface and the second surface is a non-articulating surface, wherein at least a portion of both of the first surface and the second surface is a fusion surface.
  • at least a portion of the first surface or the second surface comprises a surface finish > 125 RMS.
  • the implants are non-articulating salvage or fusion implants, wherein both surfaces comprise a non-articulating textured surface, and wherein the textured surface is a surface configured to receive a fixation compound.
  • the textured surface is a porous surface intended to mimic cancellous bone and promote ingrowth.
  • a non-articulating surface may comprise one or more fenestrations, wherein a fenestrated surface is a surface configured to receive a fixation compound.
  • the implant is configured for use in an articulating joint. In other words, the implant is configured for use in an articulating joint.
  • the implant is configured for use in the spine of an animal.
  • the implant is configured for use in the spine of a human as a spinal disc implant.
  • the implant is a unitary disc implant, having no moving components within the device.
  • an assembled disk-like implant adapted for placement between adjacent vertebral endplates comprising: a first endcap having a first outer surface and first inner surface and a first outer radial edge; an second endcap having second outer surface and second inner surface and a second outer radial edge, an intermediate core comprising an upper surface and lower surface configured to be permanently bonded between the first inner surface and the second inner surface; at least one protrusion on at least one endcap surface, wherein the at least one protrusion is configured to contact a portion of at least one adjacent vertebral endplate.
  • first endcap surface and second endcap surface are each
  • the first inner surface and second inner surface is configured to mate with the intermediate core
  • the first outer surface is an articulating surface.
  • the second outer surface is an articulating surface.
  • both the first outer surface and the second outer surface are articulating surfaces.
  • the first outer surface is a textured surface.
  • the second outer surface is a textured surface.
  • both the first outer surface and the second outer surface are textured surfaces.
  • first outer surface and second outer surface geometries are the same and comprise constant arcuate radii of curvature. In other embodiments, the first outer surface and second outer surface comprise different geometries. In still other embodiments, the first outer surface and second outer surface geometry are generally spherical.
  • only the first outer surface geometry is generally spherical.
  • only the second outer surface geometry is generally flat with radiused edges.
  • the second outer surface geometry is generally flat near the center, transitioning to generally spherical near the radial edges.
  • the second outer surface geometry is generally flat and transitioning to a proportionately large spherical radius, to replicate a worn or surgically prepared endplate surface.
  • first inner surface and the second inner surface are flat surfaces. In any one of the embodiments, the first inner surface and the second inner surface are concave surfaces. Still further, in any one of the embodiments, the first inner surface and the second inner surface are convex surfaces. Further still, in any one of the embodiments, the first inner surface and the second inner surface are non-flat surfaces.
  • textured surfaces are textured surfaces, wherein the textured surface is surface configured to receive a fixation compound intended to bond an intermediate core to the implant.
  • the intermediate core is configured to be shock-absorbing and biocompatible.
  • the intermediate core is a hydrogel.
  • the intermediate core is a polymer
  • the intermediate core upper surface is bonded to the first inner surface and the intermediate core lower surface is bonded the second inner surface, and the bond is permanent.
  • the first inner surface and the second inner surface are
  • the first endcap and second endcap are centered about a
  • some embodiments further comprise the at least one protrusion centered
  • the at least one protrusion is located off-center from the central axis.
  • first outer surface and second outer surface comprise slightly
  • first outer surface and second outer surface are inclined to each other about a central transverse plane to replicate the lordotic angle of the disc space.
  • the superior and inferior surface of the intermediate core are inclined toward each other about a central transverse axis to replicate the lordotic angle.
  • the arcuate radii of curvature of the first and second outer surfaces are essentially mirror images about a central transverse plane.
  • the planar configuration of the implant is circular in shape about the central axis. In some embodiments, the planar configuration of the implant is elliptical in shape about the central axis. In still other embodiments, the planar configuration of the implant is a polygon in shape about the central axis. In some polygon configurations, the polygon comprises at least three edges, and preferable four or more side edges. In some embodiments the side edges are straight. In some polygon configurations, the polygon comprises an irregular polygon embodiment, wherein the side edges are curved, as in a Reuleaux polygon. In other irregular embodiments, the side edges are different lengths. In still other irregular polygon embodiments, the implant configuration may comprise any combination of number of sides, straight or curved edges and or length of individual edges.
  • the implant comprises an anterior-posterior dimension that is greater than the overall arcuate height of the implant, wherein the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.01 : 1. In other embodiments, the ratio of the anterior -posterior dimension to the overall arcuate height is at least 1.1 : 1. In still other embodiments, the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.2: 1. In still other embodiments, the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.5: 1; or at least 2.0:1.
  • the implant comprises a medial-lateral dimension that is greater than the overall arcuate height of the implant, wherein the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.01 : 1. In other embodiments, the ratio of the medial -lateral dimension to the overall arcuate height is at least 1.1 :1. In still other embodiments, the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.2: 1. In still other embodiments, the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.5: 1; at least 2.0: 1, 3.0:1, or 4.0: 1.
  • the implant comprises at least two protrusions. In other embodiments, the implant comprises exactly two protrusions. In some embodiments, the protrusions will be on different bearing surfaces. In other embodiments the protrusions will be on the same bearing surface. In some embodiments, the implant will have at least two protrusions on one bearing surface and at least one protrusion on another bearing surface.
  • the implant comprises at least one conic protrusion on at least one bearing surface.
  • the bearing surface will be an articulating surface.
  • the implant comprise two endcap bearing surfaces, the first endcap further comprises a first inner surface, and the second endcap comprises a second inner surface. Still further, in some embodiments, the first inner surface and the second inner surface each comprise a recessed cavity, thus creating a third inner surface (recessed area) and fourth inner surface (recessed area) on their inner surfaces respectively.
  • the intermediate core has a raised first surface and raised second surface, wherein the raised first surface of the intermediate core is configured to mate within the recessed cavity of the third inner surface of the first endcap, and the raised second surface is configured to mate within the recessed cavity of the fourth inner surface of the second endcap.
  • endcap and the second inner surface of the second endcap comprise a protruding third surface and fourth protruding surface respectively; wherein the intermediate core has a recessed cavity in the first surface and a recessed cavity is the second surface, and wherein the recessed surface of the first surface of the intermediate core is configured to mate with the protruding third surface of the first endcap, and the recessed cavity of the second surface of the intermediate core is configured to mate with the fourth raised surface of the second endcap.
  • At least one of the first outer surface and the second outer surface is a bearing surface. Still further, in some embodiments, at least one of the first outer surface and the second outer surface is a polished bearing surface, wherein the at least one polished bearing surface has a surface finish ⁇ 4 RMS. Further still, at least one of the first outer surface and the second outer surface is an articulating surface.
  • exactly one of the bearing surfaces is an articulating surface and at least a portion of the opposite bearing surface is a textured surface.
  • at least a portion of one of the first bearing surface or second bearing surface is textured.
  • at least a portion of both the first bearing surface and the second bearing surface is textured.
  • the second outer surface is a non-articulating surface and comprises more than one protrusion.
  • the textured surface comprises more than one protrusion configured to contact a portion of at least one adjacent vertebral endplate.
  • second outer surface comprises a surface finish > 125 RMS.
  • a surface comprising a surface finish > 125 RMS is a textured surface.
  • a textured surface is a surface configured to receive a fixation compound.
  • a textured surface comprises a porous structure or porous coating, intended to mimic cancellous bone and to promote bone ingrowth.
  • the implant is configured for use in the spine of a human, wherein the implant is a spinal disc implant.
  • the implant is configured for use in the spine of a human, wherein the implant is a spinal fusion implant.
  • the implant is configured for use in the spine of a human, wherein the implant comprises an articulating surface on one side and a fusion surface on the opposite side.
  • the implant comprises a circular configuration in a
  • the implant is a unitary disc implant comprising no independent moving components.
  • the implant is a unitary disc implant comprising no independent moving components, as assembled.
  • the implant described herein may be used in a joint, other than in the spine (of a human).
  • the implant is configured for use in an articulating joint.
  • the implant is configured for use in the spine of an animal.
  • the implant is configured for use in a robotic articulating joint.
  • any one of the preceding embodiments may be configured for (human) prosthetics.
  • endplates of a vertebral joint comprising: a first endcap having a first outer surface and first inner surface, a first protruding attachment means, and an outer radial edge; a second endcap having a second outer surface and second inner surface, a second protruding attachment means configured to mate with the first protruding attachment means, and outer radial edge, an intermediate core having an upper surface and lower surface configured to mate between the first inner surface and the second inner surface, and further comprising a central opening configured to accommodate the first and second protruding attachments when assembled; at least one protrusion on at least one endcap
  • the first protruding attachment means is a protruding cylinder with a hole, centered about the central axis.
  • the first protruding attachment means is a protruding polygon having three or more sides with a hole, centered about the central axis.
  • the hole is a polygon having three or sides.
  • the hole may be a blind hole or a tapered hole.
  • the tapered hole comprises a Morse taper.
  • the second protruding attachment means is a protruding cylinder with a hole, centered about the central axis.
  • the second protruding attachment means is a protruding polygon with a hole, centered about the central axis.
  • the hole is polygonal.
  • the hole may be a blind hole or a tapered hole.
  • the tapered hole comprises a Morse taper.
  • the first protruding attachment means is a protruding cylinder, centered about the central axis.
  • the second protruding attachment means is a protruding polygon having three or more sides, centered about the central axis.
  • the second protruding attachment means is a protruding cylinder, centered about the central axis.
  • the first outer surface is an articulating surface.
  • the second outer surface is an articulating surface.
  • the first outer surface and second outer surface geometries are the same. Still further, in other embodiments, the first outer surface and second outer surface comprise different geometries.
  • the first outer surface and second outer surface geometry are generally convex. In other embodiments, the first outer surface and second outer surface geometry are generally spherical. In still other embodiments, the first outer surface geometry is generally spherical. Still further, in other embodiments, the first outer surface geometry is generally spherical to convex. Yet in other embodiments, the first outer surface geometry is generally convex to spherical.
  • the second outer surface geometry is generally flat. In other words, the second outer surface geometry is generally flat.
  • the second outer surface geometry is generally flat to convex. Yet in other words
  • the second outer surface geometry is generally flat and transitioning to a
  • the first inner surface and the second inner surface are flat surfaces.
  • the first inner surface and the second inner surface are concave surfaces.
  • the first inner surface and the second inner surface are convex surfaces. In still other embodiments, the first inner surface and the second inner surface are non-flat surfaces. In any one of the preceding embodiments the first inner surface and the second inner surface are textured surfaces. Still further, any one of textured surfaces is a surface configured to receive a fixation compound. Additionally, any one of textured surfaces is a porous coated surface configured to mimic cancellous bone and promote ingrowth.
  • the intermediate core is configured to be shock-absorbing. Further, the intermediate core is biocompatible. Further still, the intermediate core may be a hydrogel or a polymer.
  • the first surface of the intermediate core is bonded to the first inner surface of the first endcap, and the second surface of the intermediate core is bonded the second inner surface of the second endcap.
  • the bond is permanent.
  • first outer surface and second outer surface are inclined to each other about a central transverse plane to replicate the lordotic angle of the disc space.
  • the superior and inferior surface of the intermediate core are inclined toward each other about a central transverse axis to replicate the lordotic angle.
  • the arcuate radii of curvature of the first and second outer surfaces are essentially mirror images about a central transverse plane.
  • the first endcap and second endcap are centered about a central axis.
  • At least one protrusion is centered about the central axis.
  • the at least one protrusion is located off-center from the central axis.
  • first outer surface and second outer surface comprise slightly increasing arcuate radii of curvature from an outer radial edge surface to the central axis. Still further, in other embodiments, the first outer surface and second outer surface are essentially mirror images to each other about a central transverse plane.
  • the planar configuration of the implant is circular in shape about the central axis. In any one of the preceding embodiments, the planar configuration of the implant is elliptical in shape about the central axis. Still further, in any one of the preceding embodiments, the planar configuration of the implant is polygonal in shape about the central axis, wherein the polygon comprises at least three side edges, and preferably four side edges. In any one of the preceding embodiments, the planar configuration of the implant comprises an irregular Reuleaux polygon. In any one of the preceding embodiments, the irregular Reuleaux polygon may
  • BDBJS-601-001 comprise straight side edges, curved side edges or combinations of straight and curved side edges. Additionally, the lengths of the side edges need not be the same length.
  • the implant comprises an anterior-posterior dimension that is greater than the overall arcuate height of the implant.
  • the ratio of the anterior- posterior dimension to the overall arcuate height is at least 1.01 : 1.
  • the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.1 : 1.
  • the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.2: 1.
  • the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.5 : 1 , or at least 2.0: 1.
  • the implant comprises a medial-lateral dimension that is greater than the overall arcuate height of the implant.
  • the ratio of the medial -lateral dimension to the overall arcuate height is at least 1.01 : 1.
  • the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.1 : 1.
  • the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.2: 1.
  • the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.5: 1; at least 2.0: 1, at least 3.0: 1, or at least 4.0: 1.
  • the implant comprises at least two protrusions. In some embodiments, the implant comprises exactly two protrusions. In still other embodiments, the implant comprises at least one conic protrusion on at least one outer bearing surface. In some embodiments, at least one of the first outer surface and the second outer surface is an articulating bearing surface. In some embodiments, at least one of the first outer surface and the second outer surface is a polished articulating bearing surface. In some embodiments, the at least one polished articulating bearing surface has a surface finish ⁇ 4 RMS.
  • exactly one of the bearing surfaces is an articulating surface and at least a portion of the other of the surfaces is a textured surface.
  • at least a portion of at least one of the first outer surface and the second outer surface is textured.
  • at least a portion of both of the first outer surface and the second outer surface is textured.
  • both of the first outer surface and the second outer surface is a non-articulating surface.
  • at least a portion of both of the first outer surface and the second outer surface is a fusion surface.
  • the textured, non-articulating or fusion surface may comprise more than one protrusion configured to contact a portion of at least one adjacent vertebral endplate. In any one of the preceding embodiments, the textured, non-articulating or fusion surface comprises a surface finish > 125 RMS. In any one of the preceding embodiments, a textured surface is a surface
  • a textured surface comprises a porous structure or porous coating, intended to mimic cancellous bone and to promote bone ingrowth.
  • the implant is configured for use in the spine of a human, wherein the implant is a spinal disc implant.
  • the implant is configured for use in the spine of a human, wherein the implant is a spinal fusion implant.
  • the implant is configured for use in the spine of a human, wherein the implant comprises an articulating surface on one side and a fusion surface on the opposite side.
  • the implant is a unitary disc implant comprising no independent moving components.
  • the implant is a unitary disc implant comprising no independent moving components, as assembled.
  • the implant described herein may be used in a joint, other than in the spine.
  • the implant is configured for use in an articulating joint.
  • the implant is configured for use in the spine of an animal.
  • the implant is configured for use in a robotic articulating joint.
  • any one of the preceding embodiments may be configured for prosthetics.
  • a unitary implant comprising at least one tether, configured for placement in the void of a conic feature.
  • the implant further comprises at least one tether configured for placement in at least one fenestration.
  • the tether comprises at least one of: autologous tissue; allograft tissue; xenograft tissue; synthetic graft material; stem cells,
  • chondrocytes chondrocytes; proteins; and/or growth promoting factors.
  • the implant may further comprise an abutment on the second outer surface to restrict motion between the implant and the joint surface.
  • the abutment may comprise: a keel; a fin; a raised ridge; a post; or a spike.
  • the implant may comprise more than one abutment.
  • the more than one abutment may be located on more than one bearing surface.
  • Figures 1 & 2 are representative side and isometric views of a discus-shaped, unitary implant having penetrating protrusions about the central axis.
  • Figure 3 is a representative cross-sectional view of a discus-shaped, unitary implant comprising penetrating protrusions about the central axis, illustrating penetration of cartilage and or bony endplates of adjacent vertebral bodies.
  • Figures 4 & 5 are representative top (plan) and side views of the discus-shaped, unitary implant of Figure 1, illustrating variable height options as measured about the arcuate height of the implant.
  • Figures 6 & 7 are representative top (plan) and side views of an elliptically shaped unitary discus implant having penetrating protrusions about the central axis on both surfaces, illustrating variable height options as measured about the arcuate height of the implant.
  • Figures 8 & 9 are representative top (plan) and side views, of an irregular polygon- shaped unitary implant, approximating the vertebral perimeter and having penetrating protrusions about the central axis, illustrating variable height options as measured about the arcuate height of the implant.
  • Figures 10 & 11 are top and side views of a representative variant of Figure 4, illustrating variable lordosis (or kyphosis) of arcuate surfaces that are inclined relative to each other about a central Transverse plane, and represented by variable heights measured from the anterior and posterior sides of the implant.
  • Figures 12 & 13 are top and side views of a representative irregular polygon shaped implant illustrating variable lordosis (or kyphosis) of arcuate surfaces that are inclined relative to each other about a central Transverse plane, and represented by variable heights measured from the anterior and posterior sides of the implant.
  • Figure 14 is a side profile view of a discus-shaped, unitary implant variation, similar to that depicted in Figure 1, comprising a penetrating protrusions about the central axis on just one surface.
  • Figure 15 is an isometric view of the implant shown in Figure 14 illustrating an embodiment with a smooth bearing surface.
  • Figures 16 - 18 are representative top, cross-section and ISO views of an implant comprising a truncated conic protrusion on both surfaces, have a wider girth, and comprising a thru- hole, located on or about the central axis of the implant.
  • Figures 19 - 21 are representative top, cross-section and ISO views of an implant similar to one depicted in Figures 16 - 18, comprising a truncated conic protrusion on only one surface, have a wider girth, and comprising a blind hole, located on or about the central axis of the implant, which extends into the body of the implant but does not break through the opposite surface.
  • Figures 22 - 24 are representative top, cross-section and ISO views of an implant similar to one depicted in Figures 16 - 18 and comprising a biocompatible tether or wick-tethering device.
  • Figures 25 - 27 are representative top, cross-section and side views of an implant similar to one depicted in Figures 19 - 21 and comprising a biocompatible tether or wick-tethering device.
  • Figures 28 - 30 are representative side, bottom and ISO views of a discus-shaped, unitary implant having a single penetrating protrusion about the central axis on one surface and multiple protrusions on the opposite surface.
  • Figures 31 - 33 are representative side, bottom and isometric views of a discus- shaped, unitary implant having multiple penetrating protrusion on one surface and no protrusions on the opposite surface.
  • Figures 34 -36 are representative isometric views of the implant similar to Figure 33 illustrating alternate configurations comprising articulating, non-articulating and textured/fusion bearing surface combinations.
  • Figures 37 - 39 are representative section, plan and isometric views of a discus- shaped, unitary implant comprising a truncated conic protrusion about the central axis, with an optionally concentric central blind-hole. In addition, multiple anti-rotation protrusions are located on the same surface.
  • Figures 40 - 43 are representative A/P, side, bottom and isometric views of an irregular polygon-shaped (i.e.: Reuleaux polygon) unitary implant with a vertebral-approximating perimeter, comprising an elongated protruding rib or fin on one surface and a smooth opposite
  • the protruding fin is an alternative anti -rotation feature, preventing relative motion between the implant and the adjacent vertebral body.
  • Figures 44 - 47 are representative isometric views of Figure 43 comprising alternative configurations of textured surfaces.
  • Figures 48 - 51 are representative plan, cross-section, ISO and exploded views of a discus-shaped, assembled unitary implant comprising an intermediate shock-absorbing core permanently bonded between the upper and lower discus-shaped endcap components.
  • Figures 52 - 55 are representative plan, cross-section, ISO and exploded views of a discus-shaped, assembled unitary implant comprising recesses in the implant end caps, with corresponding protruding sections on the intermediate shock absorbing core, permanently bonded between the upper and lower discus-shaped endcap components
  • Figures 56 - 59 are representative plan, cross-section, ISO and exploded views of a discus-shaped, assembled unitary implant comprising end caps which employ a sliding fit mechanism to allow compressive axial movement, yet prevent lateral movement of one end cap relative to the other end cap.
  • the shock absorbing core has a central through-hole. The surfaces of the shock absorbing core are permanently bonded to adjacently mating surfaces of the end caps.
  • Figures 60 - 62 are representative ISO views of salvage / fusion devices, comprising textured or bone-ingrowth promoting surfaces on both bearing endplate surfaces.
  • Figure 63 is a representative isometric view of a Reuleaux-shaped, assembled unitary implant comprising an intermediate shock-absorbing core permanently bonded between the upper and lower endcap components.
  • Figures 64 and 65 are representative ISO views of additional salvage / fusion devices, comprising textured or bone-ingrowth promoting and/or articulating surfaces on the bearing endplate surfaces.
  • the typical joint comprises two (and sometime three or more) mating bone end surfaces that are in close proximity or direct contact, each usually covered by and separated by a layer of hyaline cartilage and typically lubricated by natural joint synovial fluids.
  • joints can also be classified functionally according to the type and degree of movement they allow; for example: Synarthrosis - permits little or no mobility. Most synarthrosis joints are fibrous joints (e.g., skull sutures): Amphiarthrosis - permits slight mobility. Most amphiarthrosis joints are cartilaginous joints (e.g., intervertebral discs): Diarthrosis - freely movable. All diarthrosis joints are synovial joints (e.g., shoulder, hip, elbow, knee, etc.), and the terms "diarthrosis” and "synovial joint” are considered equivalent by Terminologia Anatomica.
  • Diarthroses can in turn be classified into six groups according to the type of movement they allow: arthrodia, enarthrosis, ginglymus, rotary diarthrosis, condyloid
  • Joints can also be classified according to the number of axes of movement they allow, into mono-axial, biaxial and multi-axial. Still another classification is according to the degrees of freedom allowed, and distinguished between joints with one, two or three degrees of freedom. A further classification is according to the number and shapes of the articular surfaces: flat, concave and convex surfaces.
  • Joints can also be classified based on their anatomy or on their biomechanical properties. According to the anatomic classification, joints are subdivided into simple and compound, depending on the number of bones involved, and into complex and combination joints: Simple Joint: 2 articulation surfaces (e.g. shoulder joint, hip joint): Compound Joint: 3 or more articulation surfaces (e.g. radiocarpal joint), and: Complex Joint: 2 or more articulation surfaces and an articular disc or meniscus (e.g. knee joint).
  • Simple Joint 2 articulation surfaces (e.g. shoulder joint, hip joint)
  • Compound Joint 3 or more articulation surfaces (e.g. radiocarpal joint)
  • Complex Joint 2 or more articulation surfaces and an articular disc or meniscus (e.g. knee joint).
  • joints may be classified anatomically into the following groups:
  • the term "unitary" shall mean, either an individual, single- component implant, or an implant comprised of more than one component, but having no internal moving parts or components, as assembled, wherein the implant performs as a single unit, or behaves as a single component.
  • the intent of this description is to clarify that the implant component, or
  • adjacent joint surface shall mean either, the naturally occurring state, or surgically prepared joint surface which is immediately adjacent to the surgically implanted device.
  • a unitary intervertebral device comprising no independent moving components, for non-fusion articulation applications.
  • the interbody articulating device allows for limited flexion and rotation between adjacent vertebrae, helping to preserve or restore near-normal motion between adjacent vertebrae. Rotational motion is achieved through one or more protrusions incorporated into the spinal interbody device.
  • a first protrusion extends perpendicularly from the superior aspect of the discus-shape of the interbody device forming a spike or rotational cone protrusion
  • a second protrusion extends axially from the inferior aspect of the interbody device to form a second spike or rotational cone protrusion.
  • protrusions preferably extend perpendicularly from the apex of both the first and second arcuate articulating surfaces about the central axis.
  • a single protrusion extends
  • the inferior (second) surface perpendicularly from the superior (first) aspect of a circular-shape of the interbody device to form a spike or anchoring protrusion, while the inferior (second) surface is slightly rounded and smooth.
  • the inferior surface comprises a textured or bone-ingrowth promoting surface.
  • One or both of the first and / or second arcuate surfaces may be highly polished. Numerous planar geometries are described to define various profiles of the disc replacement implant which may be utilized, including irregular Reuleaux polygons. Numerous variations of the disc replacement are described. Similarly configured fusion salvage devices are also described.
  • the implant is a joint implant, having applications in artificial limbs, robotics, or other joints and mechanisms.
  • the implant is a medical implant having applications for veterinary applications intended to repair or replace a joint in an animal.
  • the implant is a human medical implant intended for a complex cartilaginous joint of the spine (intervertebral disc).
  • a unitary implant adapted for placement between adjacent surfaces of a joint comprising: a first bearing surface and a second bearing surface, wherein the first and second bearing surfaces are generally convex and configured to have bearing surface curvature that generally conforms to the concave geometry of the adjacent joint surfaces; an outer radial edge surface; and a first protrusion on the first bearing surface, as illustrated in Figs. 14 or 15, wherein the first protrusion is configured to contact a central portion of a first adjacent joint surface, and wherein the first protrusion is adapted to allow rotation about an axis.
  • convex shall be construed to mean: having an outline or surface curved like the exterior of a circle or sphere.
  • the unitary implant further comprises a second protrusion on the second bearing surface, as illustrated in any one of Figs. 1- 3, 5, 7, 9, 11, or 13, wherein the second protrusion is configured to contact a central portion of a second adjacent surface, and wherein the second protrusion is adapted to allow rotation about the common axis of the first and second protrusions.
  • the first protrusion is conical.
  • the second protrusion is conical.
  • the first protrusion or second protrusion may comprise a cone, a curved cone (sometimes referred to as parabolic or hyperbolic cones), a truncated cone, or a cylinder.
  • the protrusion may comprise any appropriate shape that would facilitate rotation, when placed about a central, rotational axis.
  • the protrusions are different on opposite surfaces. As illustrated in Fig. 3, the protrusions would intentionally penetrate the existing (or remaining) cartilage on the adjacent endplates of a joint, and at least minimally penetrate the boney endplate at or about the approximate center of rotation of the joint to stabilize the implant.
  • 1-3 is a unitary (single component), symmetric, discus-shaped device having highly polished, gradually curving superior and inferior surfaces 11 and 12 with slightly increasing arcuate geometry from the peripheral blended edges 16 and 17 to the central axis W, culminating in protrusions 13 and 14 about the central axis on both the superior 11 and inferior 12 surfaces.
  • the sidewalls of the disc implant 15 transition smoothly with blended edges 16 and 17.
  • protrusions 13 and 14 extending from the superior 11 and inferior 12 surfaces respectively, engage the adjacent cephalad 18 and caudal 19 vertebra respectively, piercing any remaining cartilage on the endplates 20 and 21 in the approximate central region of their respective bearing surfaces, to retain the disc prosthesis in position between the vertebra as shown in Fig. 3.
  • any remaining cartilage on the endplates 20 and 21 would be beneficial to the highly polished surface(s) and protrusion(s), promoting improved rotational properties for the implant about the protrusions. Additionally, over time, any minor variations between the cartilage
  • the penetrating protrusions 13 or 14 can be any surface of revolution about the central axis W where the base is broader than the tip.
  • the acute end of the tip protrusion may be pointed or slightly rounded.
  • the protrusion may have a base of any geometry projected to the tip or apex of any geometry as long as it is smaller than the base.
  • the protrusion would be configured to promote rotation about the central axis W, meaning, the protrusion(s) would be circular in nature having a single axis of rotation.
  • the penetrating protrusion tips 13 and 14 would intentionally penetrate, at least minimally, into the approximate articulating center of the superior and inferior cartilaginous covered endplates 20 and 21, or debrided bony endplates, as illustrated in FIG. 3.
  • the penetrating protrusion would have the purpose of providing a pseudo anchor, or spatial immobilizing member for the device, to position and prevent migration or expulsion of the implant during flexion / extension of the vertebral column.
  • the penetrating protrusions comprise a singular axis of revolution on the articulating surface of the implant, they would also serve as the axis of rotation between the implant and the adjacent vertebral body. Height of the protrusions can typically range from 0.3 mm to 2.5 mm.
  • the penetrating protrusions may also act as microfracture point(s) for the vertebral endplates.
  • the penetrating protrusions may also act as microfracture point(s) for the vertebral endplates.
  • the vertebral endplates are identifiable from an early embryo logical stage, and have an osseous as well as a hyaline cartilage component.
  • the cartilaginous component generates interest since it persists throughout normal maturation while the adjacent vertebrae undergo ossification. It comprises a gel of hydrated proteoglycan molecules reinforced by a network of collagen fibrils. Unlike the articular cartilage of the synovial joints, the collagen fibrils do not connect the endplate directly to the vertebral bone, although the endplate does have intimate contact with the disc through the lamellae of the inner annulus.
  • ossification Apart from a sparse vascular supply in the outer lamellae of the annulus, mature discs are almost totally reliant on diffusion of essential solutes across the endplates for nutrition and metabolic exchange.
  • Proteoglycan molecules within the matrix are critical for the control of solute transport and maintenance of water content in particular throughout the disc, and depletion of proteoglycans from the endplate cartilage is associated with loss of proteoglycans from the nucleus. It follows therefore that proteoglycan loss would ultimately lead to degeneration of the disc and endplate cartilage. Upon reaching skeletal maturity the cartilage of the endplate undergoes substantial remodeling, resulting in extensive mineralization which is eventually resorbed and replaced by true bone. Importantly, this new tissue most likely impedes the hitherto critical diffusion and nutrient exchange between the vertebral marrow, endplate cartilage and the disc. The small blood vessels within the endplate likewise become obliterated by this calcification, further limiting the exchange of vital nutrients.
  • the endplate can become re -vascularized after maturity in some species under normal and pathological conditions.
  • the re -vascularization presumed to be an attempt at tissue repair, was not able to reverse the inevitable cascade of degeneration caused by annular disruption.
  • the creation of blood vessels in the endplate occurred by activation of the matrix degrading metalloproteinase (MMP) enzymes which are normally maintained in a latent form by tissue inhibitors.
  • MMP matrix degrading metalloproteinase
  • the human spine may have similar regenerative potential to repair, or at least lubricate the cartilaginous endplate near the protruding point of fixation 13, 14 for the artificial disc, in a manner similar to the ends of long bones with synovial joints as has been previously
  • the penetrating protrusion tip(s) would cause the equivalent of a microfracture to the vertebral endplate resulting in a natural repair response from the vertebra in the form of vascular micro-vessels forming in and around the penetration point.
  • the micro-vessels would provide a means for supplying regenerative blood supply and nutrients from the vertebral marrow through the otherwise calcified endplate structure of the vertebral body to the cartilage.
  • first protrusion or second protrusion may comprise a truncated cone with a hole about the central axis, or a cylinder with a hole about the central axis.
  • the hole in the protrusion may be a blind hole or a thru-hole that penetrates through the entire implant, as illustrated in Figs. 16 - 21.
  • the implant comprises a truncated cone with a hole about the central axis, or a cylinder with a hole about the central axis
  • the implant may also comprise a tethering feature that is configured to promote ingrowth or attachment to the adjacent vertebra, as illustrated in Figs. 22-27.
  • the attachment may be to just one adjacent endplate or vertebra. In other configurations, the attachment may be to both of the adjacent endplates or vertebrae.
  • Such a tethered configuration would provide for a unique implant design that would promote a new form of pseudo-ligamentous fixation between the adjacent vertebrae, having either polished, articular bearing surfaces, fusion surfaces, or both.
  • the combined interface would potentially allow for limited rotation, where the tether would act as a substitute for native spinal ligamentous tissues.
  • the first protrusion and/or the second protrusion is adapted to penetrate at least the cartilage of the first adjacent joint surface and/or the second adjacent surface providing an extremely conservative surgical procedure. As illustrated by FIGS. 1 - 13, no special articular endplate preparation would be required to insert the implant and obtain cartilage and/or at last partial endplate penetration with the protrusion(s).
  • a first protrusion only is adapted to penetrate the endplate of a first adjacent joint surface only, as illustrated by FIGS. 14 and 15.
  • the implant may comprising a polished first bearing surface, with no protrusions, and further may comprise at least a first and second (or more protrusions) on the second bearing surface as illustrated in FIGS. 31 - 35, wherein the at least first and second protrusion are configured to contact a portion of a second adjacent surface, preferably penetrating at least a portion of the adjacent endplate, and wherein the at least first and second protrusion are adapted to prevent movement between the second bearing surface and the second adjacent surface.
  • this configuration may also comprise a textured surface in addition to the protrusions, to further promote boney or fibro-cartilage attachment between the implant and the adjacent endplate, as illustrated in FIG. 36.
  • the implant may comprise at least a second and third protrusion on the second bearing surface as illustrated in FIGS. 28 - 30, wherein the at least second and third protrusion are configured to contact a portion of a second adjacent surface, preferably penetrating at least a portion of the adjacent endplate, and wherein the at least second and third protrusion are adapted to prevent movement between the second bearing surface and the second adjacent surface.
  • the implant is generally circular in shape
  • the implant is non-circular, polygonal or irregular polygonal in shape, 30, 40 about a central axis.
  • the implant comprises an elliptical planar shape or a common variant thereof. Various non-limiting illustrations of such configurations are illustrated in FIGS. 4, 6 and 8.
  • elliptical shall mean a curve on a plane surrounding two focal points such that a straight line drawn from one of the focal points to any point on the curve and then back to the other focal point has the same length for every point on the curve.
  • a circle which is a special type of an ellipse that has both focal points at the same location, as illustrated by the non-limiting example of FIG. 6 having an elliptical perimeter 31.
  • the shape of an ellipse is represented by its eccentricity which for an ellipse can be any number from 0, (the limiting case of a circle), to arbitrarily close to, but less than 1.
  • the elliptical shape may be defined as an irregular ellipse, wherein curve on a plane surrounding two focal points such that a straight line drawn from one of the focal points to any point on the curve and then back to the other focal point has the similar, but variable lengths for every point on the curve.
  • the implant shape may resemble a
  • the Reuleaux polygon shape 40 may be in the form of an irregular polygon, wherein at least one or more sides of the polygon are straight, or wherein at least one side has a different length than the remaining sides. Still further the Reuleaux polygon shape may be in the form of an irregular Reuleaux polygon, wherein at least one or more sides of the polygon are curved 41, or wherein at least one (curved) side has a different length than the remaining sides, as illustrated by the non-limiting examples of FIGS. 8, 12, and 40 - 47. Still further the Reuleaux polygon shape may have a combination of straight and curved sides.
  • the implant comprises an anatomic-like bearing surface, wherein the curvature of the first bearing surface 11, 33, 43 and the second bearing surface 12, 34, 44 is generally spherical or near spherical.
  • the geometry of these bearing surfaces can either be a surface of revolution about a center axis W, as represented by surfaces 11 and 12 in implant 10; or they can be any swept surface as represent by surfaces 33, 34, 43 and 44 in implants 30 and 40 or a
  • a swept surface is defined as the geometry resulting from a sectional curve following a path of another curve.
  • a lofted surface is defined as the surface geometry formed by a matrix of varying section curves in one direction along with varying section curves in another direction where the direction of the two sets of curves are different from each other. Typically, the direction of the curves are normal to each other, but do not need to be.
  • the curvature of the first bearing surface and the second bearing surface is generally multi-radial in order to more closely match the native or prepared endplate surface.
  • the first bearing surface and the second bearing surface geometries are the same.
  • the first bearing surface and the second bearing surface comprise different geometries.
  • first bearing surface and the second bearing surface are mirrored, or symmetrical about a central transverse plane, wherein the overall arcuate height 23, 32, and 43 is constant, as illustrated in the non-limiting examples of FIGS. 5, 7 and 9.
  • first bearing surface and the second bearing surface are inclined to each other about a central transverse plane to better match or reconstruct the natural curvature or lordosis and kyphosis of the spine, as illustrated in the non-limiting examples of FIGS. 11 and 13.
  • the angle of inclination of the superior surface relative to the inferior surface is commonly referred to as the lordotic angle, and typically ranges between 0.1 and 20 degrees, or more particularly between 4 and 15 degrees. (However, in some cases this angle may be as high as 25 degrees).
  • the lordotic angle 47 is such that the height on the anterior surface 45 is almost always greater than the posterior surface 46.
  • the lordosis or inclination angle between the first and second bearing surfaces may also be directly implied by describing an implant with different anterior 24 and posterior 25 dimensions.
  • the angle of inclination is referred to as a kyphotic angle, the opposite of lordosis.
  • the first bearing surface and the first protrusion are polished articulating surfaces as illustrated in the non-limiting examples of FIGS. 28 and 29.
  • the second bearing surface and the second protrusion are polished articulating surfaces as illustrated in the non-limiting examples of FIGS. 14 and 15.
  • the central protrusion 51 resides on only one surface of the implant verses protrusions 13 and 14 on both surfaces (Fig. 11). Typically this protrusion would be on the inferior surface. However, it could also be located on the superior surface.
  • the surface 52 opposite the surface with the protrusion 51 is sufficiently smooth and polished in order to articulate against the native cartilage or endplate, while
  • This embodiment of one central protrusion on either the inferior or superior surface, but not both, can be incorporated with any of the previously mentioned perimeter geometries (22, 31 and 41) with superior and inferior surfaces positioned either approximately parallel to each other (Fig 11) when viewed perpendicular to the coronal plane or at a lordotic angle 47, (Fig. 13).
  • bearing surfaces and protrusions are polished articulating surfaces, as illustrated in the non-limiting examples of FIGS. 1 - 13.
  • first bearing surface or second bearing surface may comprise or be manufactured from at least one of the following materials:
  • the unitary implant may comprise a core fabricated from one material having one set of properties, and an outer bearing surface fabricated from another material having a different set of properties.
  • a pyrolytic carbon implant may have a graphite core and a pyrolytic carbon exterior for bearing surfaces.
  • an implant may have a first bearing surface with one set of material properties (i.e. low abrasion articulating surface), and a second bearing surface comprising different material properties (i.e.: fixation promoting surface), and an intermediate core comprising yet a third set of material properties (dampening, shock-absorbing properties).
  • a unitary disc implant adapted for placement between adjacent vertebral surfaces of a spinal joint comprising: a first bearing surface and a second bearing surface, wherein the first and second bearing surfaces are generally convex and configured to have curvature that generally conforms to the concave geometry of the adjacent spinal joint surfaces; an outer radial edge surface; a first protrusion on the first bearing surface, wherein the first protrusion is configured to contact a central portion of a first adjacent spinal joint surface, a second protrusion on the second bearing surface, wherein the second protrusion is configured to contact a central portion of a second adjacent spinal surface, wherein the first protrusion and second protrusion are adapted to allow rotation about an axis, as illustrated in FIGS. 1 - 13, 16 - 18 and 48 -58.
  • a unitary spinal disc implant adapted for placement between adjacent vertebral endplates comprising: a first bearing surface and an second bearing surface, wherein the first and second bearing surfaces are generally convex and configured to have a spherical curvature geometry that conforms to the concave geometry of adjacent endplate surfaces; an outer radial edge surface that blends into the first and the second bearing surfaces; a conic protrusion on at least one bearing surface for penetrating at least one of the adjacent endplates,
  • the first bearing surface is an articulating surface.
  • the second bearing surface is an articulating surface.
  • the first bearing surface and second bearing surface geometries are the same.
  • the first bearing surface and second bearing surface comprise different geometries, with such differences as illustrated between FIGS 34 and 36 or the superior surface of FIG. 42 and the inferior surfaces of FIGS. 44-48.
  • the first bearing surface and second bearing surface geometry are generally convex. In some embodiments, the geometry of the first bearing surface and / or second bearing surface is generally spherical. In some embodiments the first bearing surface geometry is generally flat to spherical.
  • the second bearing surface geometry is generally flat to spherical.
  • the second bearing surface geometry may be generally flat with radiused edges.
  • the second bearing surface geometry may be generally flat and transitioning to a proportionately large spherical radius to replicate a worn or surgically prepared endplate surface.
  • Such variations in the second bearing surface would be advantageous when addressing the surgical desire to match or closely replicate a surface that is either severely abraded due to (compressive) arthritic wear, or a surface that is surgically scraped by the surgeon to remove osteophytes, and disrupted or torn cartilage, resulting in a less than natural radius of curvature on this surface which might otherwise interfere with the function of the implant.
  • the inferior is often easier for surgeon to access with instruments, depending on the surgical approach used.
  • first bearing surface and second bearing surface comprise slightly increasing arcuate radii of curvature from the outer radial edge surface to the central axis.
  • the arcuate radii of curvature of the first and second bearing surfaces are essentially mirror imaged about a central transverse plane.
  • the width of the implant or chord of the arc (in either the sagittal or coronal plane) has a range between 17.0 mm and 69.0 mm, whereas the height of the spherical radius of curvature of the of the bearing surface comprises a range between 0.1 mm (generally flat) and 5.0 mm.
  • the spherical radius can be variable within the full spectrum of these ranges, in both planes simultaneously, meaning that a given bearing surface can have more than one spherical radius at any given measurement point.
  • the spherical radii would be nearly constant for the majority of the surface area (i.e.: >60%) in any one axis, before blending to the radial edges.
  • the spherical radius may be customized to better accommodate different spherical radii of the endplate surface near the center of the endplate versus the spherical radius near the perimeter of the endplate (the epiphyseal rim), accounting for central endplate wear, abrasion or surgical preparation, as may be typically seen on the inferior endplate.
  • Customized, variable spherical radii can now readily be achieved in
  • the second outer surface geometry is generally flat with radiused edges. In others, the second outer surface geometry is generally flat to convex. Still further, in some embodiments, the second outer surface geometry is generally flat and transitioning to a proportionately large spherical radius, as described above, to replicate a worn or surgically prepared endplate surface, typically representing the inferior endplate in a spinal joint.
  • the anatomic body planes are the imaginary flat surfaces that are used to define a particular area of anatomy. The most common ones being: The Frontal or Coronal Plane which vertically divides the front and back halves of the entire body; The Median, Midsagittal or Sagittal Plane - which vertically divides the left and right sides of the entire body; and The
  • Transverse or Horizontal Plane which divides the body (horizontal to the ground) at the waist (top and bottom halves of the body).
  • the terms are applied universally to any bone in the spine.
  • the first bearing surface and second bearing surface are centered about a central axis, wherein the implant surfaces are essentially symmetric about both the coronal and sagittal planes. Further still, the at least one conic protrusion is centered about the central axis. In other embodiments, the at least one conic protrusion is located off-center from the central axis. An example of this can be seen in FIGS. 28 - 30.
  • the implant comprises an anterior-posterior (front to back) dimension that is greater than the overall arcuate height of the implant.
  • This dimensional configuration can be provided in a range and may be represented by a ratio wherein the anterior- posterior dimension to the overall arcuate height is at least 1.01 : 1 ; is at least 1.1 : 1 ; or is at least 1.2: 1, etc., for non-limiting example, as illustrated in FIGS. 4 and 5, 6 and 7, or 8 and 9.
  • the implant comprises a medial-lateral dimension that is greater than the overall arcuate height of the implant.
  • This dimensional configuration can also be provided in a range and may be represented by a ratio wherein the medial-lateral dimension to the overall arcuate height is at least 1.01 : 1; is at least 1.1 : 1; is at least 1.2: 1, etc., for non-limiting example.
  • the implant comprises at least two protrusions. In other embodiments, the implant comprises exactly two protrusions. In still other embodiments, the implant comprises at least one protrusion on at least one bearing surface, wherein the at least one protrusion is conic.
  • the at least one conic protrusion is a truncated cone 61, 62, 71 comprising a base diameter 64, 65 with a wider girth at the base than the top 66, 67 and may further comprise an inner void 63, 72 as illustrated in any of the non-limiting examples of FIGS. 16 - 27.
  • the void may be a blind hole 73, 74, or it may be a void that extends through the entire implant 63.
  • the conic protrusions, and holes or voids would be concentric about a central axis. In other embodiments neither the conic protrusions nor voids would be concentric, or centered about a central axis.
  • an embodiment 60 comprises truncated conic protrusions 61 and 62 respectively located at the center or the approximate center of superior and inferior surfaces 68, 69 respectively, similar to protrusions 13 and 14 (Fig. 1) except that they have a larger base perimeter (64, 65) and truncated top (66, 67) to accommodate a thru-hole 63 sized to allow for bone or tissues ingrowth, or graft material that is intended to provide additional capture, further minimizing the potential for expulsion.
  • the perimeter or cross section geometry of the thru- hole can either be a circle, preferred for manufacturing reasons, or any other geometry.
  • the size of the thru-hole 63 is a size that accommodates and promotes bone or tissue ingrowth. This size, generally, will typically have a sectional area range equivalent to diameters ranging from 2.0 mm to 10.0 mm, but may be larger or smaller.
  • the surface finish of the thru-hole 63 may be textured to provide better adhesion properties for ingrowth of tissue. A surgeon may decide to fill this through
  • Another embodiment 70 represented by Figs. 19 - 21, comprises a protrusion 71 with a blind hole 72 on just one surface 75 that can be either the superior or inferior surface of the implant.
  • the geometry of the protrusion is similar to 61 and 62 previously mentioned (Fig. 17) and the average sectional width 73 of blind hole 72 is similar to previously mentioned thru-hole 63.
  • the depth 74 of the blind hole may at a minimum be about 0.5 mm, and at a maximum depth being approximately 1.0 mm from the point of breaking through the opposite surface 76.
  • the surface finish of the blind hole 72 may be textured to provide better adhesion properties for ingrowth of tissue.
  • the hole may be inversely tapered to promote a better anchoring reservoir that would resist pullout of the anchoring materials under natural loading conditions.
  • This embodiment can be incorporated with any of the previously mentioned perimeter geometries (22, 31 and 41) with superior and inferior surfaces positioned either approximately parallel to each other when viewed perpendicular to the coronal plane, or at a lordotic angle 47. A surgeon may decide to fill this blind hole with harvested bone chips or synthetic bone (graft material) with or without bone growth stimulators.
  • embodiment of the invention 80 illustrates one example of the previous illustration wherein a surgeon can utilize a biocompatible tether or wicking tether 81.
  • implant 90 shown in Figs. 25 - 27 illustrates another example where the blind hole 72 contains a biocompatible tether or wicking tether 91.
  • tethering devices 81 and 91 function in a fashion similar to an artificial ligament, by promoting growth of new tissue between the disc implant and the adjacent vertebral body(s) creating an additional stabilizing structure for the spinal joint segment.
  • the surface finish of the blind hole may be textured to provide better adhesion properties for ingrowth of tissue.
  • the hole may be inversely tapered to promote a better anchoring reservoir that would resist pullout of the anchoring materials under natural loading conditions.
  • the tether could be cross-pinned (not shown) through the side wall of the implant to fix it within the implant.
  • the tethers 81 and 91 could be fabricated from any number of materials, including autologous tissues, allograft tissues, xenografts tissues, or a variety of artificial, man-made synthetic graft materials. These materials could also be impregnated or treated with stem cells, chondrocytes, proteins or other growth promoting factors to further the likelihood of a successful graft.
  • FIGS. 28 - 30, another embodiment 100 of the invention is similar to discs 10, 30, and 40 except there are two or more protrusions 101 on one bearing surface 102, that can either be the inferior surface or the superior surface, as well as one protrusion 103 on the other
  • the multiple protrusions 101 each of which shaped as previous defined protrusions 13 and 14, can be located anywhere on the surface 102 and are intended to prevent this surface 102 from moving relative to the adjacent vertebral endplate (as depicted in FIG. 3 - 20 or 21).
  • One of the protrusions 101 can be located at the center of surface 102 with one or more protrusions located off center. Or all of the protrusions can be located in areas other than the center of surface 102.
  • embodiment 110 is similar to that depicted by 100 except that there are no protrusions on surface 113.
  • the surface 113 is similar to previously defined articulating surface 52.
  • another embodiment 120 (Fig. 36),
  • a roughened, coated or porous surface 122 comprises a roughened, coated or porous surface 122.
  • Surface roughness (such as grit blasted, textured, porous, laser sintered, roughened porous spray titanium or as coated pyrolytic carbon); coatings (such as Hydroxyapatite); porous coating (such as porous titanium, tantalum or silicon nitride); or porous formation (such as chemical etching of the surface); on the bearing surface(s) are meant to promote fibrous or bony on-growth and/or ingrowth as a means of further anchoring the device.
  • These surface treatments are those commonly known to the industry and one skilled in the art.
  • At least one protrusion is configured to puncture the adjacent endplate when the implant is positioned between vertebrae.
  • the heights of the various protrusions may not all be the same.
  • the truncated cone 131 may be set at one height, whereas the other smaller diameter conic protrusions 133 may have a different height.
  • embodiment 130 features a combination of an enlarged central protrusion 131 with a blind hole 132 in addition to one or more protrusions 133 on the surface 135, comprising combined features of previous embodiments.
  • All versions of this embodiment can be incorporated with any previously mentioned perimeter geometries (22, 31 and 41) with superior and inferior surfaces positioned either approximately parallel to each other when viewed perpendicular to the coronal plane or at a lordotic angle 47, (FIGS. 11& 12). Additionally, each variation of this embodiment can be incorporated with a roughened, coated or porous surface 122 (Fig. 36), as previously described.
  • Alternate configurations of this implant include embodiments comprising irregular polygon shapes, or irregular Reuleaux polygons.
  • One such embodiment 140 is now illustrated in (FIGS. 40 - 43) comprises a fin or keel shaped abutment 142 on the surface 141 that could be either the inferior surface or the superior surface. This abutment is intended to prevent articulation of surface 141 against the adjacent vertebral body endplate (either 20 or 21 in Fig. 3) while allowing the
  • the length 145 of the abutment 142 can range anywhere between 20% - 80% of the implant anterior to posterior (A/P) dimension 146.
  • the fin sectional geometry 147 is generally rectangular with beveled surfaces 151 at the apex 148 or any geometry where the base 149 is larger than the apex 148.
  • the non-articulating surface 141 can either be relatively smooth, or comprise a textured, roughened, porous coated, or a sintered porous surface 152 (Fig. 44) to further ensure that the surface does not articulate relative to the adjacent vertebral endplate when implanted.
  • At least one of the first bearing surface and the second bearing surface comprises at least one fenestration.
  • a fenestration is any hole, window or opening, of any size or shape, in the surface of the implant.
  • the at least one fenestration may be circular or non-circular in profile, and/or a blind void or hole 162, 181.
  • the fenestration may also be a ridge and groove combination 171 -174 in a surface. Or more than one fenestration may be present, with each having a different configuration 181, 182, 184. Examples of various non- limiting configurations of fenestrations are illustrated in FIGS. 45 - 47.
  • Embodiment 160 (Fig. 45) employs two or more cavities 162, in addition to a keel, on surface 161 in order to promote bony ingrowth, further immobilizing the implant relative to the adjacent vertebral body endplate when implanted.
  • the section or perimeter of each cavity can either be circular, as preferred for manufacturing reasons, or be any polygon or closed curve geometry
  • the diameter or equivalent diameter can range from 0.5 mm to 3.0 mm.
  • the depth of the cavity can range between 0.5 mm to a depth that is within 1.0 mm of breaking through the opposite surface.
  • Yet another embodiment 170 features one or more ridges 171 protruding from surface 174 that further immobilize surface 174 from articulating against the adjacent vertebral endplate when implanted.
  • the trajectory 173 of the ridge sectional geometry 172 can be a line or any curve whose path is not parallel to the length 145 of the fin abutment 142.
  • a first preferred orientation is perpendicular to the fin.
  • a second preferred orientation is between 15 - 45 ° offset from perpendicular, pointing toward the anterior of the device. In this orientation, insertion into the joint space is enhanced, while removal or unintentional anterior movement is hindered.
  • the section 172 of the ridge(s) can be triangular or any geometry where the base of the section merging with surface 174 is greater than the apex or tip of the ridge.
  • the height of the ridge section projected from the surface 174 can range from 0.3 mm to 0.8 mm.
  • the width of the base of the ridge(s) can range
  • FIG. 47 Yet another version of this embodiment 180 (Fig. 47) combines the cavities 181 and ridges 182. Versions 160, 170 and 180 of this embodiment can either have relatively smooth surfaces or textured surfaces as defined by 152. All versions of fins, fenestrations and ridges illustrated in these embodiments can be incorporated with any of the previously mentioned perimeter geometries (22, 31 and 41) with superior and inferior surfaces positioned either approximately parallel to each other when viewed perpendicular to the coronal plane or at a lordotic angle 47, (Fig. 12).
  • At least one of the first bearing surface and the second bearing surface is polished, wherein the at least one polished bearing surface has a surface finish ⁇ 4 RMS.
  • the at least one of the first bearing surface and the second bearing surface is an articulating surface.
  • exactly one of the surfaces is an articulating surface and at least a portion of the other of the surfaces is a textured surface. In some embodiments, at least a portion of at least one of the first surface and the second surface is textured.
  • both of the first surface and the second surface is textured, as illustrated in non-limiting FIGS. 36, 44, 60, 61, and surfaces 122, 152.
  • both of the first surface and the second surface is a non-articulating surface, wherein at least a portion of both of the first surface and the second surface is a fusion surface.
  • at least a portion of the first surface or the second surface comprises a surface finish > 125 RMS. Typically, these surfaces are textured and / or porous to some degree.
  • one or more of the bearing surfaces comprise a textured surface, wherein the textured surface is a roughened surface configured to receive a fixation compound.
  • Such surfaces may be machined textured, laser finished textured surfaces, chemically treated (i.e.: acid etched), or comprise a metallurgically applied coating.
  • one or more bearing surfaces may comprise a textured surface, wherein the textured surface is a porous coating.
  • the porous coating is intended to replicate the pore structure of cancellous bone.
  • Typical materials for textured and porous coated surfaces include: CPTi, CoCr beads, tantalum, porous PEEK, etc.
  • a coating can be configured from any chemically compatible material that will securely bond to the base material of the implant.
  • a non-articulating surface may comprise one or more fenestrations, wherein a fenestrated surface is a surface configured to receive a fixation compound.
  • a fixation compound may comprise a biologic or polymerizing cements.
  • Biologic examples include morselized bone graph or paste, or any comparable bone-graft-
  • fixation compound may comprise a combination of any one of the aforementioned biologic and polymerizing cements.
  • Fixation compounds may be used to permanently fix an implant to a surface; or alternately may be used to permanently bond assembled (implant) components together.
  • a disk-like implant adapted for placement between adjacent vertebral endplates comprising: a first endcap having a first outer surface and first inner surface and a first outer radial edge; a second endcap having second outer surface and second inner surface and a second outer radial edge, an intermediate core having an upper surface and lower surface configured to mate between the first inner surface and the second inner surface; at least one protrusion on at least one endcap surface, wherein the at least one protrusion is configured to contact a portion of at least one adjacent vertebral endplate.
  • disk-like implants comprising a first and second endcap and an intermediate core.
  • first endcap surface and second endcap surface are each configured to have an external bearing geometry configured to conform to the geometry of adjacent endplate surfaces.
  • the first inner surface and second inner surface is configured to mate with the intermediate core
  • the first outer surface is an articulating surface.
  • the second outer surface is an articulating surface.
  • first outer surface and second outer surface geometries are the same and comprise constant arcuate radii of curvature. In other embodiments, the first outer surface and second outer surface comprise different geometries. In still other embodiments, the first outer surface and second outer surface geometry are generally spherical.
  • only the first outer bearing surface geometry is generally spherical. In others, only the first outer bearing surface geometry is generally spherical to flat. In some embodiments, the second outer bearing surface geometry is generally spherical. In still others, the second outer bearing surface geometry generally spherical to flat. In still others, the second outer bearing surface geometry is generally flat with spherical radiused edges blending to the sides. In any
  • the spherical geometry may vary from one anatomic plane to another plane.
  • the articulating implant 190 comprises a shock- absorbing core 191 sandwiched between the first and second endcaps 194.
  • This core 191 imparts a cushioning effect in place of the natural disc nucleus.
  • the durometer of the shock-absorbing core / ring would be selected to provide anatomically appropriate stiffness to replace the natural disc stiffness, yet be selected from polymers having high compressive wear and fatigue resistance.
  • This core 191 would be permanently bonded to the internal end cap surfaces 195 of the two end caps 194 of implant 190 eliminating the potential for any relative movement at the interface 197 between the core 191 and the end caps 194.
  • the height or thickness 192 of the intermediate core 191 comprises a range between 1.0 mm and 15.0 mm.
  • the height 193 of the individual endcaps 194 will comprise a range between 1.0 mm 6.0 mm.
  • the height of the insert 191 plus two end caps 194 will comprise the overall arcuate height 199 of the implant.
  • Preferred embodiments would comprise cervical implants with an overall arcuate height 199 similar to 23 defined in Fig. 5, ranging between 4.0 - 12.0 mm.
  • preferred embodiments of lumbar implants would have an overall height ranging between 8.0 - 24.0 mm.
  • the superior and inferior bearing surfaces 196 would be highly polished, as well as one protrusion 198 centered on both surfaces 196, as previously described.
  • the endplates incorporate a pocket 201 in the interior surface of the end caps 202 and corresponding protrusions 204 on both surfaces of the shock-absorbing core 203.
  • the intent of the core protrusions 204 and end cap pockets 201 is to further prevent the possibility of movement of the core 203 relative to the end caps 202 in addition to permanent bonding of the interfaces between these components.
  • the height 205 of both end cap pockets 201 will range from .5 mm to 1.5 mm.
  • the diametral size and height of the core protrusions 204 can range from a loose slip fit to a line-to-line interference fit (as is commonly known in the industry) with the end cap pockets 201.
  • the core would be permanently bonded to the mating endcaps.
  • the superior and inferior bearing surfaces 206 would be highly polished, as well as one protrusion 207 centered on both surfaces 206, as previously described.
  • (200) would comprise and inverse configuration, wherein there would are pockets in the core and corresponding protrusions in the end caps, in addition to permanent bonding of the interfaces.
  • the endcaps comprise a sliding fit mechanism comprising of a protrusion 211 that engages a
  • the shock-absorbing core 213 has a corresponding thru-hole 214 that will provide clearance with the hub 218 sliding fit mechanism. This core 214 would be permanently bonded to the end caps 215 at the interfaces 220 created by the interior surfaces of the endcaps 219 and the superior and inferior surfaces 217 of the shock-absorbing core 213.
  • All versions of this embodiment can be incorporated with any of the previously mentioned perimeter geometries (22, 31 and 41) with superior and inferior surfaces positioned either approximately parallel to each other (as illustrated in Fig 11) when viewed perpendicular to the coronal plane, or at a lordotic angle 47, (as illustrated in Fig. 12).
  • the superior and inferior bearing surfaces 216 would be highly polished, as well as one protrusion 221 centered on both surfaces 216, as previously described.
  • the first protruding attachment means is a protruding cylinder with a hole, centered about the central axis.
  • the first protruding attachment means is a protruding polygon having three or more sides with a hole, centered about the central axis.
  • the hole is a polygon having three or sides.
  • the hole may be a blind hole or a tapered hole.
  • the tapered hole comprises a Morse taper.
  • the second protruding attachment means is a protruding cylinder with a hole, centered about the central axis.
  • the second protruding attachment means is a protruding polygon with a hole, centered about the central axis.
  • the hole is polygonal.
  • the hole may be a blind hole or a tapered hole.
  • the tapered hole comprises a Morse taper.
  • the first inner surface and the second inner surface are textured surfaces, wherein the textured surface is surface configured to receive a fixation compound intended to bond an intermediate core to the implant.
  • the intermediate core is configured to be shock- absorbing and biocompatible.
  • the intermediate core is a hydrogel.
  • the intermediate core is a polymer.
  • the intermediate core upper surface is bonded to the first inner surface and the intermediate core lower surface is bonded the second inner surface, and the bond is permanent.
  • the first inner surface and the second inner surface are essentially parallel to each other about a central transverse plane.
  • first inner surface and the second inner surface are not parallel, and are inclined toward each other about a central transverse plane, (not shown). More specifically, implants 190, 200 (FIGS. 48 - 55), may be configured to have an intermediate core, with inclined superior and inferior surfaces intended to replicate specific lordotic or kyphotic spinal angles.
  • any of the circular embodiments described throughout this specification comprise diametral dimensions in the range of 17.0 mm - 45.0 mm, (corresponding to the anticipated A P dimension [sagittal plane depth] of the vertebral endplate), whereas the height of the spherical radius of curvature for the endcap bearing surface comprises a range between 0.1 mm (generally flat) and 5.0 mm.
  • the implants comprise corresponding M/L dimensions (coronal plane, width) in the range of 24.0 mm - 69.0 mm, in addition to the A/P (sagittal plane, depth) and height of the spherical radius of curvature dimensions described previously.
  • first outer surface and second outer surface are inclined to each other about a central transverse plane.
  • the angle of inclination is representative of the desired degree of lordosis (or kyphosis) to be incorporated into the implant.
  • any of the circular, elliptical or irregular Reuleaux polygon-shaped implants described throughout this specification comprise a lordosis included angle between the ranges of 0 ° - 20 ° .
  • the inclined angle, or lordosis (or kyphosis) angle is incorporated into the intermediate core, i.e.: FIGS. 48 - 55.
  • the inclined angle, or lordosis (or kyphosis) angle is incorporated into the endcaps, i.e.: FIGS 56 - 59.
  • the arcuate radii of curvature of the first and second outer surfaces are essentially mirror imaged about a central transverse plane.
  • the implant comprises an anterior-posterior dimension that is greater than the overall arcuate height of the implant. In some embodiments, the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.01 : 1. In some embodiments,
  • the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.1 : 1. In still other embodiments, the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.2:1. In still other embodiments, the ratio of the anterior-posterior dimension to the overall arcuate height is at least 1.5 : 1 , or at least 2.0: 1.
  • the implant comprises a medial-lateral dimension that is greater than the overall arcuate height of the implant.
  • the ratio of the medial- lateral dimension to the overall arcuate height is at least 1.01 : 1. In other embodiments, the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.1 : 1. In still other
  • the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.2: 1. In still other embodiments, the ratio of the medial-lateral dimension to the overall arcuate height is at least 1.5 :1; at least 2.0: 1, at least 3.0: 1, or at least 4.0: 1.
  • At least one of the first outer surface and the second outer surface is a bearing surface. Still further, in some embodiments, at least one of the first outer surface and the second outer surface is a polished bearing surface, wherein the at least one polished bearing surface has a surface finish ⁇ 4 RMS. Further still, at least one of the first outer surface and the second outer surface is an articulating surface.
  • exactly one of the bearing surfaces is an articulating surface and at least a portion of the other of the surfaces is a textured surface.
  • at least a portion of at least one of the first outer surface and the second outer surface is textured.
  • at least a portion of both of the first outer surface and the second outer surface is textured.
  • both the first outer surface and the second outer surface is a non-articulating surface.
  • the textured surface comprises more than one protrusion configured to contact a portion of at least one adjacent vertebral endplate.
  • the fusion surface comprises more than one protrusion configured to penetrate a portion the adjacent vertebral endplate.
  • At least a portion of the first outer surface or the second outer surface comprises a surface finish > 125 RMS.
  • a surface comprising a surface finish > 125 RMS is a textured or porous coated surface or a surface intended to mimic a cancellous bone structure.
  • a textured or porous coated surface is a surface configured to receive a fixation compound.
  • Figs. 60 - 62, 64, 65 are fusion or salvage implant embodiments.
  • Salvage implants refer to those instances where a former
  • Fusion or salvage implants may incorporate various forms of traditional fusion augmentation hardware such as screws and plates and may also include other supplemental augmentation such as stabilizing structures attached to the adjacent vertebrae to further capture the implant within the vertebral joint.
  • supplemental augmentation stabilizing structures may include allograft, autograft, synthetic graft materials, or combinations thereof. Additionally these supplemental augmentation stabilizing structures may further be augmented with growth promoting materials such as collagen, fibrin, chondrocytes, stem cells, peptides or growth hormones or other growth promoting factors.
  • the implant is circular in the transverse (horizontal) plane.
  • the implant is elliptical in the transverse
  • the implant is an irregular Reuleaux polygon in the transverse (horizontal) plane, wherein the major medial-lateral (M/L) dimension is greater than the major anterior-posterior (A/P) dimension.
  • the implant is also configured with an intermediate core (not shown), configured to be a shock absorber that would mimic the natural disc, while also replacing lost disc height.
  • the implant is configured for use in the spine of a human, wherein the implant is a spinal disc implant.
  • the implant is configured for use in the spine of a human, wherein the implant is a spinal fusion implant.
  • the implant is configured for use in the spine of a human, wherein the implant comprises an articulating surface on one side and a fusion surface on the opposite side.
  • the implant is a unitary disc implant comprising no independent moving components.
  • the implant is a unitary disc implant comprising no independent moving components, as assembled.
  • the implant is a joint implant, having applications in artificial limbs, robotics, or other joints and mechanisms.
  • the implant is a medical implant having applications for veterinary applications.
  • the implant of the subject specification is a human medical implant intended for the spine.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif intervertébral unitaire, qui n'a aucun composant mobile, pour des applications d'articulation sans fusion. Le dispositif d'articulation intersomatique permet une flexion et une rotation limitées entre des vertèbres adjacentes, aidant à préserver ou à rétablir un mouvement presque normal entre des vertèbres adjacentes. Un mouvement de rotation est obtenu au moyen d'une ou plusieurs saillies incorporées dans le dispositif intersomatique vertébral. Dans une forme d'articulation, une première saillie s'étend perpendiculairement à partir de l'aspect supérieur du dispositif intersomatique en forme de disque pour former une pointe ou saillie de rotation, tandis qu'une seconde saillie s'étend axialement à partir de l'aspect inférieur du dispositif intersomatique pour former une seconde pointe ou saillie de rotation. Des saillies s'étendent, de préférence, perpendiculairement à partir du sommet des première et seconde surfaces d'articulation arquées. Dans une autre forme, une saillie unique s'étend axialement à partir de l'aspect supérieur d'une forme circulaire du dispositif intersomatique pour former une pointe ou saillie d'ancrage, tandis que la surface inférieure peut être légèrement arrondie et/ou comprenant une surface favorisant la croissance osseuse. Dans une autre forme, les première et/ou seconde surfaces arquées peuvent être hautement polies. De nombreuses géométries planes sont décrites pour définir divers profils de l'implant de remplacement de disque qui peut être utilisé, comprenant des polygones de Reuleaux irréguliers. L'invention concerne de nombreuses variations du remplacement de disque et des procédés d'utilisation. L'invention concerne également des dispositifs de sauvetage de fusion configurés de façon similaire.
PCT/US2014/015850 2013-02-11 2014-02-11 Implant de disque vertébral unitaire Ceased WO2014124453A2 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017038918A (ja) * 2015-08-18 2017-02-23 ライト メディカル テクノロジー インコーポレイテッドＷｒｉｇｈｔ Ｍｅｄｉｃａｌ Ｔｅｃｈｎｏｌｏｇｙ， Ｉｎｃ． インプラントおよびそれを製造する方法
WO2020191044A1 (fr) * 2019-03-19 2020-09-24 Mullin Brad Implants et procédés de fusion d'articulation sacro-iliaque

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1318469C (fr) * 1989-02-15 1993-06-01 Acromed Corporation Disque artificiel
US20060276790A1 (en) * 2005-06-02 2006-12-07 Zimmer Spine, Inc. Minimally invasive facet joint repair
US8932355B2 (en) * 2008-02-22 2015-01-13 Coalign Innovations, Inc. Spinal implant with expandable fixation
US20120191193A1 (en) * 2011-01-26 2012-07-26 Warsaw Orthopedic Interbody implant system and methods of use

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017038918A (ja) * 2015-08-18 2017-02-23 ライト メディカル テクノロジー インコーポレイテッドＷｒｉｇｈｔ Ｍｅｄｉｃａｌ Ｔｅｃｈｎｏｌｏｇｙ， Ｉｎｃ． インプラントおよびそれを製造する方法
WO2020191044A1 (fr) * 2019-03-19 2020-09-24 Mullin Brad Implants et procédés de fusion d'articulation sacro-iliaque
US11857420B2 (en) 2019-03-19 2024-01-02 Brad MULLIN Sacroiliac joint fusion implants and methods

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