Apparatus, systems, and methods for achieving lumbar facet fusion

• US 8,858,601 B2
• Filed: 05/20/2013
• Issued: 10/14/2014
• Est. Priority Date: 08/09/2004
• Status: Active Grant

• Current Assignee: SI-Bone, Incorporated
• Original Assignee: SI-Bone, Incorporated
• Inventors: Reiley, Mark A.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): Negrellirodrigue, Christina
• Application Number:
  US13/898,415
• Publication Number:
  US 20130253654A1
• Time in Patent Office: 512 Days
• Field of Search: 606/246, 606/279, 606/95, 606/96, 606/98, 606/99, 606/104, 606/247, 623 1711- 1716
• US Class Current: 606/279
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30576 : with extending fixation tabs
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30622 : Implant for fusing a joint or bone material
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• 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 2002/4238 : for tarso-metatarsal joints, i.e. TMT joints
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• 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 2310/00329 : Glasses, e.g. bioglass
• 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 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics

Abstract

Assemblies of one or more implant structures make possible the achievement of diverse interventions involving the fusion and/or stabilization of lumbar and sacral vertebra in a non-invasive manner, with minimal incision, and without the necessitating the removing the intervertebral disc. The representative lumbar spine interventions, which can be performed on adults or children, include, but are not limited to, lumbar interbody fusion; translaminar lumbar fusion; lumbar facet fusion; trans-iliac lumbar fusion; and the stabilization of a spondylolisthesis.

Claims

1. A method for translaminal lumbar fusion, the method comprising:

creating an insertion path that extends from a superior articular process of a selected lumbar vertebra, cranially through the adjoining facet capsule into a corresponding inferior articular process of an adjacent lumbar vertebra, and, from there, further through the lamina of the adjacent vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent vertebra,

providing a bone fixation implant comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex, wherein the elongated implant structure comprises an exterior surface region treated to provide bony in-growth or through-growth along the implant structure; and

inserting the bone fixation implant through the insertion path from the superior articular process of the selected lumbar vertebra, cranially through the adjoining facet capsule into the inferior articular process of the adjacent lumbar vertebra, and, from there, further through the lamina of the adjacent vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent vertebra.

2. The method according to claim 1 wherein the bony in-growth region or through-growth region comprises a porous plasma spray coating on the implant structure.

3. The method according to claim 1 wherein the insertion path is created in a non-invasive manner.

4. The method according to claim 1 wherein the insertion path comprises a bore sized approximately at or approximately about an outer maximum dimension of the bone fixation implant.

5. The method according to claim 1 wherein at least a first implant structure extends from a superior articular process of the selected lumbar vertebra, in a cranial direction through the adjoining facet capsule into the corresponding inferior articular process of the adjacent lumbar vertebra, and, from there, further through the lamina of the adjacent lumbar vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent lumbar vertebra, and wherein at least a second implant structure extends from an opposite superior articular process of the selected lumbar vertebra, through the adjoining facet capsule into the corresponding inferior articular process of the adjacent vertebra, and, from there, further through the lamina of the adjacent lumbar vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent lumbar vertebra, the first and second implant structures crossing each other within the medial lamina of adjacent lumbar vertebra.

6. The method according to claim 1 wherein the insertion path extends from the superior articular process of lumbar vertebra L5, cranially through the adjoining facet capsule into an inferior articular process of the lumbar vertebra L4, and, from there, further through the lamina of the lumbar vertebra L4 into an interior opposite posterolateral region adjacent the spinous process of the lumbar vertebra L4.

7. The method according to claim 1 wherein at least a first implant structure extends from a left superior articular process of the lumbar vertebra L5, in a cranial direction through the adjoining facet capsule into the corresponding left inferior articular process of the adjacent lumbar vertebra L4, and, from there, further through the lamina of the adjacent lumbar vertebra L4 into an interior right posterolateral region adjacent the spinous process of the adjacent lumbar vertebra L4, and wherein at least a second implant structure extends from a right superior articular process of the selected lumbar vertebra L5, through the adjoining facet capsule into the corresponding right inferior articular process of the adjacent lumbar vertebra L4, and, from there, further through the lamina of the adjacent lumbar vertebra L4 into an interior left posterolateral region adjacent the spinous process of the adjacent lumbar vertebra L4, the first and second implant structures crossing each other within the medial lamina of adjacent lumbar vertebra L4.

8. The method according to claim 1, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least two apices.

9. The method according to claim 1, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least three apices.

10. A system comprising at least one bone fixation implant comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex, wherein the elongated implant structure comprises an exterior surface region treated to provide bony in-growth or through-growth along the implant structure inserted through an insertion path from a superior articular process of a selected lumbar vertebra, cranially through the adjoining facet capsule into the corresponding inferior articular process of the adjacent lumbar vertebra, and, from there, further through the lamina of the adjacent vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent vertebra to affect translaminal lumbar fusion.

11. The system according to claim 10 wherein the elongated implant structure has a triangular cross section.

12. The system according to claim 11 wherein the bony in-growth region or through-growth region comprises a porous plasma spray coating on the implant structure.

13. The system according to claim 10, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least two apices.

14. The system according to claim 10, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least three apices.

15. A system comprising at least a first implant structure comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex, wherein the elongated implant structure comprises an exterior surface region treated to provide bony in-growth or through-growth along the implant structure inserted through an insertion path from a superior articular process of the selected lumbar vertebra, in a cranial direction through the adjoining facet capsule into the corresponding inferior articular process of the adjacent lumbar vertebra, and, from there, further through the lamina of the adjacent lumbar vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent lumbar vertebra, and at least a second implant structure comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex, wherein the elongated implant structure comprises an exterior surface region treated to provide bony in-growth or through-growth along the implant structure inserted through an insertion path from an opposite superior articular process of the selected lumbar vertebra, through the adjoining facet capsule into the corresponding inferior articular process of the adjacent vertebra, and, from there, further through the lamina of the adjacent lumbar vertebra into an interior opposite posterolateral region adjacent the spinous process of the adjacent lumbar vertebra, the first and second implant structures crossing each other within the medial lamina of adjacent lumbar vertebra to affect translaminal lumbar fusion.

16. The system according to claim 15 wherein the bony in-growth region or through-growth region comprises a porous plasma spray coating on the implant structure.

17. The system according to claim 15, wherein both the first elongated implant structure and the second elongated implant structure have a cross-sectional profile transverse to the longitudinal axis that is defined by at least two apices.

18. The system according to claim 15, wherein both the first elongated implant structure and the second elongated implant structure have a cross-sectional profile transverse to the longitudinal axis that is defined by at least three apices.

19. A method for lumbar facet fusion comprising creating an insertion path that extends from an inferior articular process of a selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into a corresponding superior articular process of an adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra, providing a bone fixation implant comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex and including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure, and inserting the bone fixation implant through the insertion path from the inferior articular process of the selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra.

20. The method according to claim 19 wherein the bony in-growth region or through-growth region comprises a porous plasma spray coating on the implant structure.

21. The method according to claim 19 wherein the insertion path is created in a non-invasive manner.

22. The method according to claim 19 wherein the insertion path comprises a bore sized approximately at or approximately about an outer maximum dimension of the bone fixation implant.

23. The method according to claim 19 wherein at least a first implant structure extends from a left inferior articular process of the selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra, and wherein at least a second implant structure extends from a right inferior articular process of the selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra.

24. The method according to claim 19 wherein at least a first implant structure extends from an inferior articular process of the lumbar vertebra L4, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra L5 and into a pedicle of the adjacent lumbar vertebra L5.

25. The method according to claim 19 wherein at least a first implant structure extends from a left inferior articular process of the lumbar vertebra L4, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra L5 and into a pedicle of the adjacent lumbar vertebra L5, and wherein at least a second implant structure extends from a right inferior articular process of the selected lumbar vertebra L4, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra L5 and into a pedicle of the adjacent lumbar vertebra L5.

26. The method according to claim 19, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least two apices.

27. The method according to claim 19, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least three apices.

28. A system comprising a bone fixation implant comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex and including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure inserted through an insertion path from an inferior articular process of a selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into a corresponding superior articular process of an adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra to affect lumbar facet fusion.

29. The system according to claim 28 wherein the bony in-growth region or through-growth region comprises a porous plasma spray coating on the implant structure.

30. The system according to claim 28, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least two apices.

31. The system according to claim 28, wherein the elongated implant structure has a cross-sectional profile transverse to the longitudinal axis that is defined by at least three apices.

32. A system comprising at least a first implant structure comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex and including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure that extends from a left inferior articular process of a selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into a corresponding superior articular process of an adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra, and at least a second implant structure comprising an elongated implant structure having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis that is defined by at least one apex including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure that extends from a right inferior articular process of the selected lumbar vertebra, in a caudal direction through the adjoining facet capsule into the corresponding superior articular process of the adjacent lumbar vertebra and into a pedicle of the adjacent lumbar vertebra, the first and second implant structures affecting lumbar facet fusion.

33. The system according to claim 32 wherein the bony in-growth region or through-growth region comprises a porous plasma spray coating on the implant structure.

34. The system according to claim 32, wherein both the first elongated implant structure and the second elongated implant structure have a cross-sectional profile transverse to the longitudinal axis that is defined by at least two apices.

35. The system according to claim 32, wherein both the first elongated implant structure and the second elongated implant structure have a cross-sectional profile transverse to the longitudinal axis that is defined by at least three apices.