Systems and methods for the fusion of the sacral-iliac joint

• US 9,662,128 B2
• Filed: 05/08/2015
• Issued: 05/30/2017
• 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): Hammond, Ellen C
• Assistant Examiner(s): NEGRELLIRODRIGUEZ, CHRISTINA
• Application Number:
  US14/707,817
• Publication Number:
  US 20150238205A1
• Time in Patent Office: 753 Days
• Field of Search: 606246, 606279, 606300-321, 606 80, 606 95, 606 96, 606 99, 606 86 A, 606104, 623 1711, 623 2211, 623 2212
• 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 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1664 for the hip
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 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 17/683 comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/686 Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/84 Fasteners therefor or fasteners being internal fixation devices
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• 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 17/8665 Nuts
• CPC Class Codes: A61B 17/8685 comprising multiple separate parts
• 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 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 17/8891 at its periphery
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/681 : Alignment, compression, or distraction mechanisms
• CPC Class Codes: A61B 2017/8675 : clamping effect due to tapering, e.g. conical thread
• 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

The sacral-iliac joint between an iliac and a sacrum is fused either by the creation of a lateral insertion path laterally through the ilium, through the sacral-iliac joint, and into the sacrum, or by the creation of a postero-lateral insertion path entering from a posterior iliac spine of an ilium, angling through the sacral-iliac joint, and terminating in the sacral alae. A bone fixation implant is inserted through the insertion path and anchored in the interior region of the sacrum or sacral alae to fixate the sacral-iliac joint.

Claims

1. A method of forming a bore in the ileum, across the sacroiliac joint, and into the sacrum to receive an implant having a cross-sectional profile defined by a plurality of apices, the method comprising:

inserting a guide pin into the ileum, across the sacroiliac joint, and into the sacrum;

disposing a drill bit over the guide pin, the drill bit having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the drill bit, the drill bit having a lumen configured to receive the guide pin;

drilling a bore along the guide pin with the drill bit, the bore extending from the ileum, across the sacroiliac joint, and into the sacrum;

removing the drill bit from the guide pin;

disposing a broach over the guide pin, the broach having longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the broach that is defined by a plurality of apices and that matches in shape the cross-sectional profile of the implant, the broach having a lumen configured to receive the guide pin, wherein the cross-sectional profile of the broach is larger than the cross-sectional profile of the drill bit; and

shaping the bore with the broach such that the cross-sectional profile of the bore matches the shape of the cross-sectional profile of the implant, wherein the step of shaping the bore with the broach comprises advancing the broach along the guide pin from the ileum, across the sacroiliac joint, and into the sacrum.

2. The method of claim 1, wherein the cross-sectional profile of the broach is triangular.

3. The method of claim 1, wherein the cross-sectional profile of the broach is square.

4. The method of claim 1, wherein the cross-sectional profile of the broach is rectangular.

5. The method of claim 1, wherein the cross-sectional profile of the broach is a combination of rectilinear and curvilinear portions.

6. The method of claim 1, wherein the step of shaping the bore with the broach comprises tapping the broach into the bore.

7. The method of claim 1, wherein the cross-sectional profile of the bore is smaller than that of the cross-sectional profile of the implant.

8. A method of forming a bore in the ileum, across the sacroiliac joint, and into the sacrum to receive an implant having a cross-sectional profile defined by a plurality of apices, the method comprising:

drilling a bore through the ileum, across the sacroiliac joint, and into the sacrum with a drill bit, the drill bit having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the drill bit; and

shaping the bore with a broach such that the cross-sectional profile of the bore matches the shape of the cross-sectional profile of the implant, the broach having longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the broach that is defined by a plurality of apices and that matches in shape the cross-sectional profile of the implant, wherein the cross-sectional profile of the broach is larger than the cross-sectional profile of the drill bit, wherein the step of shaping the bore with the broach comprises advancing the broach along the guide pin from the ileum, across the sacroiliac joint, and into the sacrum.

9. The method of claim 8, wherein the cross-sectional profile of the broach is triangular.

10. The method of claim 8, wherein the cross-sectional profile of the broach is square.

11. The method of claim 8, wherein the cross-sectional profile of the broach is rectangular.

12. The method of claim 8, wherein the cross-sectional profile of the broach is a combination of rectilinear and curvilinear portions.

13. The method of claim 8, wherein the step of shaping the bore with the broach comprises tapping the broach into the bore.

14. The method of claim 8, wherein the cross-sectional profile of the bore is smaller than that of the rectilinear cross-sectional profile of the implant.

15. A method of forming a bore in the ileum, across the sacroiliac joint, and into the sacrum to receive an implant having a cross-sectional profile defined by a plurality of apices, the method comprising:

inserting a guide pin into the ileum, across the sacroiliac joint, and into the sacrum;

disposing a soft tissue protector over the guide pin;

disposing a drill bit through the soft tissue protector and over the guide pin, the drill bit having a longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the drill bit, the drill bit having a lumen configured to receive the guide pin;

drilling a bore along the guide pin with the drill bit, the bore extending from the ileum, across the sacroiliac joint, and into the sacrum;

removing the drill bit from the guide pin;

disposing a broach over the guide pin, the broach having longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the broach that is defined by a plurality of apices and that matches in shape the cross-sectional profile of the implant, the broach having a lumen configured to receive the guide pin, wherein the cross-sectional profile of the broach is larger than the cross-sectional profile of the drill bit; and

shaping the bore with the broach such that the cross-sectional profile of the bore matches the shape of the cross-sectional profile of the implant.

16. The method of claim 15, further comprising:

disposing a guide pin sleeve over the guide pin; and

removing the guide pin sleeve before the step of disposing the drill bit over the guide pin.

17. The method of claim 15, wherein the step of shaping the bore with the broach comprises advancing the broach along the guide pin from the ileum, across the sacroiliac joint, and into the sacrum.

18. A method of forming a bore in the ileum, across the sacroiliac joint, and into the sacrum to receive an implant having a cross-sectional profile defined by a plurality of apices, the method comprising:

inserting a guide pin into the ileum, across the sacroiliac joint, and into the sacrum;

disposing a broach over the guide pin, the broach having longitudinal axis and a cross-sectional profile transverse to the longitudinal axis of the broach that is defined by a plurality of apices and that matches in shape the cross-sectional profile of the implant, the broach having a lumen configured to receive the guide pin, wherein the cross-sectional profile of the broach is larger than the cross-sectional profile of the drill bit; and

forming a bore with a broach such that the cross-sectional profile of the bore matches the shape of the cross-sectional profile of the implant, wherein the step of forming the bore with the broach comprises advancing the broach along the guide pin from the ileum, across the sacroiliac joint, and into the sacrum.