Systems and methods for the fixation or fusion of bone at or near a sacroiliac joint

• US 9,675,394 B2
• Filed: 05/16/2014
• Issued: 06/13/2017
• 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): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US14/280,360
• Publication Number:
  US 20140257415A1
• Time in Patent Office: 1,124 Days
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/846 Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface A61B17/72, A61B17/86 take precedence
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• 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 2002/30995 : for sacro-iliac joints
• 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

At least one bone fixation device comprising a stem having a maximum outer diameter is inserted into the sacroiliac joint through a minimally invasive incision path sized approximately at or about the maximum outer diameter of the stem in soft tissue, into the iliac bone, across the sacroiliac joint and into the sacrum. The stem is inserted through the incision path to a position within the sacroiliac joint between the iliac bone and the sacrum, to fuse the sacroiliac joint, without invasive joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint. Desirably, at least a portion of the stem includes a surface permitting bony in-growth.

Claims

1. A method for fixing or fusing a sacroiliac joint, the method comprising:

providing a bone fixation device comprising a stem having a maximum outer diameter and a rectilinear cross section;

creating an insertion path sized approximately at or about the maximum outer diameter of the stem in soft tissue and into the sacroiliac joint; and

without prior or subsequent joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint besides the creation of the insertion path, inserting the stem through the insertion path to a position within the sacroiliac joint between an iliac bone and a sacrum, to fuse the sacroiliac joint.

2. The method of claim 1, wherein at least a portion of the stem includes a surface permitting bony in-growth.

3. The method of claim 1, wherein the rectilinear cross section is square.

4. The method of claim 1, wherein the rectilinear cross section is rectangular.

5. The method of claim 1, wherein the rectilinear cross-section is triangular.

6. A method for fixing or fusing a sacroiliac joint, the method comprising:

creating an insertion path through an iliac bone, across the sacroiliac joint, and into a sacrum, the insertion path having a cross-sectional profile matching a cross-sectional profile of an implant configured to be inserted into the insertion path; and

inserting the implant through the insertion path and across the sacroiliac joint without any prior or subsequent joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint besides the creation of the insertion path, the implant extending from a surface of the iliac bone, across the sacroiliac joint, and into the sacrum, wherein the step of inserting the implant comprises applying an axial, non-rotational force to the implant to drive the implant through the insertion path.

7. The method of claim 6, wherein the implant and the insertion path both have a rectilinear cross-sectional profile.

8. The method of claim 6, further comprising inserting a guide pin through the iliac bone, across the sacroiliac joint, and into the sacrum prior to the step of creating an insertion path.

9. The method of claim 8, further comprising drilling a bore over the guide pin through the iliac bone, across the sacroiliac joint, and into the sacrum.

10. The method of claim 6, further comprising shaping a bore through the iliac bone, across the sacroiliac joint, and into the sacrum to create the insertion path.

11. The method of claim 6, wherein the cross-sectional profile of the insertion path is smaller than that of the cross-sectional profile of the implant.

12. The method of claim 6, wherein the step of creating the insertion path comprises drilling a bore through the iliac bone, across the sacroiliac joint, and into the sacrum.

13. A method for fixing or fusing a sacroiliac joint, the method comprising:

creating an insertion path through an iliac bone, across the sacroiliac joint, and into a sacrum, the insertion path having a cross-sectional profile matching a cross-sectional profile of an implant configured to be inserted into the insertion path; and

inserting the implant through the insertion path and across the sacroiliac joint without any prior or subsequent joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint besides the creation of the insertion path, the implant extending from a surface of the iliac bone, across the sacroiliac joint, and into the sacrum, wherein the implant does not provide axial compression of the sacroiliac joint.

14. The method of claim 13, wherein the implant and the insertion path both have a rectilinear cross-sectional profile.

15. The method of claim 13, wherein the step of inserting the implant comprises applying an axial, non-rotational force to the implant to drive the implant through the insertion path.

16. The method of claim 13, further comprising inserting a guide pin through the iliac bone, across the sacroiliac joint, and into the sacrum prior to the step of creating an insertion path.

17. The method of claim 16, further comprising drilling a bore over the guide pin through the iliac bone, across the sacroiliac joint, and into the sacrum.

18. The method of claim 13, wherein the cross-sectional profile of the insertion path is smaller than that of the cross-sectional profile of the implant.

19. The method of claim 13, wherein the step of creating the insertion path comprises drilling a bore through the iliac bone, across the sacroiliac joint, and into the sacrum.

20. The method of claim 13, further comprising shaping a bore through the iliac bone, across the sacroiliac joint, and into the sacrum to create the insertion path.

21. A method for fixing or fusing a sacroiliac joint, the method comprising:

creating an insertion path through an iliac bone, across the sacroiliac joint, and into a sacrum, the insertion path having a cross-sectional profile matching a cross-sectional profile of an implant configured to be inserted into the insertion path; and

inserting the implant through the insertion path and across the sacroiliac joint without any prior or subsequent joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint besides the creation of the insertion path, the implant extending from a surface of the iliac bone, across the sacroiliac joint, and into the sacrum, wherein the cross-sectional profile of the insertion path is smaller than that of the cross-sectional profile of the implant.

22. A method for fixing or fusing a sacroiliac joint, the method comprising:

providing a bone fixation device comprising a stem having a maximum outer diameter;

creating an insertion path sized approximately at or about the maximum outer diameter of the stem in soft tissue and into the sacroiliac joint; and

without prior or subsequent joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint besides the creation of the insertion path, inserting the stem through the insertion path to a position within the sacroiliac joint between an iliac bone and a sacrum, to fuse the sacroiliac joint, wherein the step of inserting the implant comprises applying an axial, non-rotational force to the implant to drive the implant through the insertion path.

23. A method for fixing or fusing a sacroiliac joint, the method comprising:

providing a bone fixation device comprising a stem having a maximum outer diameter;

creating an insertion path sized approximately at or about the maximum outer diameter of the stem in soft tissue and into the sacroiliac joint; and

without prior or subsequent joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint besides the creation of the insertion path, inserting the stem through the insertion path to a position within the sacroiliac joint between an iliac bone and a sacrum, to fuse the sacroiliac joint, wherein the insertion path has a cross-sectional profile that is smaller than that of a cross-sectional profile of the stem of the bone fixation device.