Spinal facet joint implant

• US 8,926,700 B2
• Filed: 06/02/2004
• Issued: 01/06/2015
• Est. Priority Date: 12/10/2003
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Gmedelware 2 LLC
• Inventors: Hoy, Robert W., Triplett, Daniel J., Fallin, T. Wade, Chervitz, Alan, Justin, Daniel F.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/860,487
• Publication Number:
  US 20050131537A1
• Time in Patent Office: 3,870 Days
• Field of Search: 623 1711- 1712
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/7049 Connectors, not bearing on the vertebrae, for linking longitudinal elements together A61B17/7055, A61B17/7053, A61B17/7019 take precedence
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/8695 Washers surrounding screw head in plate hole A61B17/8047, between bone plate and bone A61B17/8028
• CPC Class Codes: A61B 2017/8655 with special features for locking in the bone
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30154 square
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30171 rosette- or star-shaped
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/30426 Bayonet coupling
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30514 using a locking washer
• CPC Class Codes: A61F 2002/30574 with an integral complete or partial collar or flange
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30663 : multiaxial, e.g. biaxial; multipolar, e.g. bipolar or having an intermediate shell articulating between the ball and the socket
• CPC Class Codes: A61F 2002/3082 : Grooves
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30934 : Special articulating surfaces
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0021 : square
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00928 : Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass

Abstract

Superior and/or inferior facets of one or more facet joints may be replaced by superior and/or inferior facet joint prostheses. In one embodiment, a kit of superior or inferior prostheses is provided, in which the prostheses have at least two dimensions that vary among members of the kit independently of each other. Each prosthesis may have a bone engaging surface having a surface that is polyaxially rotatable against a corresponding resection of a vertebra. Each prosthesis may also have an articulating surface shaped such that, after attachment to the spine, the replaced or partially replaced facet joints provide a larger medial-lateral range of motion when the spine is flexed than when the spine is extended. Crosslinks may be used to connect left and right prosthesis together in such a manner that they are stabilized in a position in which they are seated directly against the vertebra.

Claims

1. A spinal implant kit for replacing at least one removed facet of a resected vertebra, wherein the resected vertebra has a pedicle saddle point (S1) defining an intersection between a posterior pedicle bone surface and a longitudinal axis of the pedicle wherein the at least one removed facet is a natural right superior facet, a natural left superior facet, a natural right inferior facet, or a natural left inferior facet, wherein the at least one removed facet has an articulating surface that, prior to removal of the at least one removed facet has a most medial and anterior point (P1), the spinal implant kit comprising:

a plurality of fixation elements; and

a plurality of components for replacing a first facet of the at least one removed facet, wherein the components have the same parametric features characterized by a first dimension and a second dimension;

wherein each of the components is of monolithic construction and comprises a generally convex semispherical surface, wherein the first and second dimensions vary in magnitude disproportionately relative to each other among the components such that a subset of the components is selectable to provide a selected prosthesis dimensioned to match a morphology of the resected vertebra;

wherein a subset of the fixation elements is selectable to attach the selected prosthesis to the resected vertebra,

wherein the selected prosthesis comprises;

an articulating surface positioned to approximate an original position of the first facet when the selected prosthesis is attached to the resected vertebra; and

a bone apposition surface to abut a resection surface of the vertebra;

wherein the first and second dimensions define at least one of the bone apposition surface and the articulating surface;

wherein the semispherical surface is incorporated in a ball and socket joint when the selected prosthesis is attached to the resected vertebra,

wherein the articulating surface is concave and comprises one or more planar portions,

wherein each of the components is configured with an aperture that extends completely there through.

2. The spinal implant kit of claim 1, wherein the selected prosthesis comprises a superior facet prosthesis, wherein the first facet is a natural superior facet.

3. The spinal implant kit of claim 2, wherein the first dimension comprises a resection angle (α

) defining an orientation of the bone apposition surface and the second dimension comprises a facet angle (β

) defining an orientation of the articulating surface.

4. The spinal implant kit of claim 3, wherein the selected prosthesis further comprises:

an implant pedicle saddle point positioned to substantially overlie S1 when the selected prosthesis is attached to the resected vertebra; and

a radius of articulation (R) defining a radius of curvature of the articulating surface.

5. The spinal implant kit of claim 3, wherein a ranges in magnitude from about 30°

to about 70° and

β

ranges from about 60°

to about 100°

.

6. The spinal implant kit of claim 2, wherein the first and second dimensions are determined by measuring an x offset (X1) between S1 and P1 and a y offset (Y1) between S1 and PI and selecting first and second dimensions that are predetermined for a given Xl value and a given YI value.

7. The spinal implant kit of claim 2, wherein the articulating surface of the selected prosthesis has a most medial and anterior point (P1), a most posterior and lateral point (P4), and an implant pedicle saddle point positioned to substantially overlie S1 when the selected prosthesis is attached to the resected vertebra, wherein the first and second dimensions are selected from the group consisting of a resection angle (α

) defining an orientation of the bone apposition surface, an x offset (Xl) between S1 and PI, a y offset (Yl) between SI and PI, an x offset (X4) between SI and P4. a y offset (Y4) between S1 and P4, a facet angle (β

) defining an orientation of the articulating surface, and a facet articulation radius (R) defining a radius of curvature of the articulating surface.

8. The spinal implant kit of claim 1, wherein a second selected prosthesis comprises a third and fourth prosthesis that comprise an inferior facet prostheses for replacing a second facet of the at least one removed facet.

9. The spinal implant kit of claim 8, wherein the articulating surface of the second selected prosthesis has a radius of articulation (IR) defining a radius of curvature of the articulating surface, wherein the second selected prosthesis further comprises an implant pedicle saddle point positioned to substantially overlie S1 when the second selected prosthesis is attached to the resected vertebra, wherein the first dimension comprises a resection angle (Iα

) defining an orientation of the bone apposition surface and the second dimension comprises a z offset (Z) between Si and a center of IR.

10. The spinal implant kit of claim 8, wherein the first and second dimensions are determined by measuring one or more of an x offset (IX) between S1 and a second pedicle saddle point (S2) of an adjacent vertebra, a y offset (IY) between S1 and S2 and a z offset (IZ) between S I and S2, and selecting first and second dimensions that are predetermined for one or more of a given IX value, a given IY value, and a given IZ value.

11. The spinal implant kit of claim 8, wherein the articulating surface of the second selected prosthesis has a center of a radius of articulation (IR) defining a radius of curvature of the articulating surface and an implant pedicle saddle point positioned to substantially overlie S1 when the selected prosthesis is attached to the resected vertebra, wherein the first dimension is selected from the group consisting of a resection angle Iα

defining an orientation of the bone apposition surface, a z offset (Z) between S1 and the center of IR, a facet angle (Iβ

) defining an orientation of the articulating surface, and IR.

12. The spinal implant kit of claim 11, wherein the first dimension comprises Iα

and the second dimension comprises Z.

13. The spinal implant kit of claim 12, wherein Iα

and Z are determined by measuring one or more of an x offset (IX) between S1 and a second pedicle saddle point (S2) of an adjacent vertebra, a y offset (IY) between S1 and S2, and a z offset (IZ) between S1 and S2, and selecting Iα

and Z that are predetermined for one or more of a given IX value, a given IY value, and a given IZ value.

14. The spinal implant kit of claim 12, wherein Iα

ranges in magnitude from about 30°

to about 70° and

Z ranges from about 20 mm to about 40 mm.

23. The spinal implant kit of claim 1, further comprising a third and a fourth prosthesis which comprise inferior facet prostheses for replacing a second facet of the at least one removed facet.

24. The spinal implant kit of claim 23, wherein each of the third and fourth prostheses comprises an articulating surface having a radius of articulation (IR) defining a radius of curvature of the articulating surface and an implant pedicle saddle point positioned to substantially overlie Si when the selected prosthesis is attached to the resected vertebra, wherein the first dimension comprises a resection angle (Iα

) defining an orientation of a flat surface positioned to lie against a resection surface of the resected vertebra and the second dimension comprises a z offset (Z) between S1 and a center IR.

25. The spinal implant kit of claim 24, wherein Iα

and Z are determined by measuring one or more of an x offset (IX) between S1 and a second pedicle saddle point (S2) of an adjacent vertebra, a y offset (IY) between S1 and S2, and a z offset (IZ) between S1 and S2, and selecting Iα

and Z that are predetermined for one or more of a given IX value, a given IY value, and a given IZ value.

26. The spinal implant kit of claim 23, wherein the first and second dimensions are determined by measuring one or more of an x offset (IX) between S1 and a second pedicle saddle point (S2) of an adjacent vertebra, a y offset (1Y) between S1 and S2, and a z offset (IZ) between S1 and S2, and selecting first and second dimensions that are predetermined for one or more of a given IX value, a given IY value, and a given IZ value.

27. The spinal implant kit of claim 23, wherein each of the third and fourth prostheses comprises an articulating surface having a center of a radius of articulation (IR) defining a radius of curvature of the articulating surface, wherein each of the third and fourth prostheses further comprises an implant pedicle saddle point positioned to substantially overlie when the selected prosthesis is attached to the resected vertebra, wherein the first dimension is selected from the group consisting of a resection angle (Iα

) defining an orientation of a flat surface positioned to lie against a resection surface of the resected vertebra, a z offset (Z) between Si and the center of IR, a facet angle (Iβ

) defining an orientation of the articulating surface, and 1R.

28. The spinal implant kit of claim 27, wherein the first dimension comprises Iα

and the second dimension comprises Z.

29. The spinal implant kit of claim 28, wherein Iα

and Z are determined by measuring one or more of an x offset (IX) between S1 and a second pedicle saddle point (S2) of an adjacent vertebra, a y offset (IY) between S1 and S2, and a z offset (IZ) between S1 and S2, and selecting Iα

and Z that are predetermined for one or more of a given IX value, a given IY value, and a given IZ value.

30. The spinal implant kit of claim 28, wherein Iα

ranges in magnitude from about 30°

to about 70° and

Z ranges from about 20 mm to about 40 mm.

15. A spinal implant kit for replacing at least one removed facet of a resected vertebra, wherein the resected vertebra has a pedicle saddle point (Sl) defining an intersection between a posterior pedicle bone surface and a longitudinal axis of a pedicle, wherein the at least one removed facet is a natural right superior facet, a natural left superior facet, a natural right inferior facet, or a natural left inferior facet, wherein the at least one removed facet has an articulating surface that, prior to removal of the at least one removed facet has a most medial and anterior point (P1), the spinal implant kit comprising:

a plurality of fixation elements; and

a plurality of components for replacing a first facet of the at least one removed facet, wherein the components are of a single parametric design characterized by a first dimension and a second dimension;

wherein each of the components is of monolithic construction and comprises a generally convex semispherical surface, wherein the first and second dimensions vary in magnitude disproportionately relative to each other among the components such that a subset of the components is selectable to provide a selected prosthesis dimensioned to match a morphology of the resected vertebra.;

wherein a subset of the fixation elements is selectable to attach the selected prosthesis to the resected vertebra;

wherein, when the selected prosthesis is attached to the resected vertebra, the semispherical surface encircles at least one of the subset of the fixation elements and the selected prosthesis comprises an articulating surface positioned to approximate an original position of the first facet,

wherein the plurality of components comprises a first prosthesis and a second prosthesis, each of which is independently selectable to provide the selected prosthesis, wherein the first dimension of the second prosthesis has a magnitude different from a magnitude of the first dimension of the first prosthesis, wherein either of the first and second prostheses is selectable to provide the selected prosthesis,

wherein the articulating surface is concave and comprises one or more planar portions,

wherein each of the components is configured with an aperture that extends completely therethrough.

16. The spinal implant kit of claim 15, wherein the first and second prostheses comprise superior facet prostheses, wherein the first facet is a natural superior facet.

17. The spinal implant kit of claim 16, wherein the first dimension comprises a resection angle (α

) defining an orientation of a flat surface positioned to lie against a resection surface of the resected vertebra and the second dimension comprises a facet angle β

, defining an orientation of the articulating surface.

18. The spinal implant kit of claim 17, wherein a ranges in magnitude from about 30°

to about 70° and

β

ranges from about 60°

to about 100°

.

19. The spinal implant kit of claim 17 wherein α

and β

are determined by measuring an x offset (X1) between S1 and PI and a y offset (Yl) between S1 and PI and selecting α

and β

that are predetermined for a given X1 value and a given Yl value.

20. The spinal implant kit of claim 19, wherein each of the first and second prostheses further comprises an implant pedicle saddle point positioned to substantially overlie Sl when the selected prosthesis is attached to the resected vertebra and a radius of articulation (R) defining a radius of curvature of the articulating surface of the first and second prostheses.

21. The spinal implant kit of claim 16, wherein the first and second dimensions are determined by measuring an x offset (X1) between S1 and P1 and a y offset (Yl) between S1 and P1 and selecting first and second dimensions that are predetermined for a given X1 value and a given Yl value.

22. The spinal implant kit of claim 16, wherein each of the :

first and second prostheses comprises an articulating surface having a most medial and anterior point (P1) and a most posterior and lateral point (P4), wherein each of the first and second prostheses further comprises an implant pedicle saddle point positioned to substantially overlie Si when the selected prosthesis is attached to the resected vertebra, wherein the first and second dimensions are selected from the group consisting of a resection angle (α

) defining an orientation of a flat surface positioned to lie against a resection surface of the resected vertebra, an x offset (X1) between S1 and P1, a y offset (Y1) between SI and Pl, an x offset (X4) between S1 and P4, a y offset (Y4) between Sl and P4, a facet angle (β

) defining an orientation of the articulating surface, and a facet articulation radius (R) defining a radius of curvature of the articulating surface.

31. The spinal implant kit of claim 15, further comprising third, fourth, fifth and sixth prostheses, each of which has a magnitude of the first dimension different from magnitudes of the first dimension of the remainder of the first, second, third, fourth, fifth, and sixth prostheses.