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

• US 8,986,348 B2
• Filed: 10/05/2010
• Issued: 03/24/2015
• 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): Hoffman, Mary
• Assistant Examiner(s): NEGRELLIRODRIGUE, CHRISTINA
• Application Number:
  US12/924,782
• Publication Number:
  US 20110087294A1
• Time in Patent Office: 1,631 Days
• Field of Search: 606/95, 606/96, 606/99, 606/104, 606/86.A, 606/279, 623/16.11, 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 17/1659 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 for the fusion of the sacral-iliac joint between an iliac and a sacrum comprising creating a lateral insertion path laterally through the ilium, through the sacral-iliac joint, and into the sacrum, providing a bone fixation implant free of external screw threads, wherein the bone fixation implant comprises an elongated implant structure having a longitudinal axis and a rectilinear cross section transverse to the longitudinal axis and including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure, inserting the bone fixation implant through the insertion path laterally from the ilium, through the sacral-iliac joint, and into the sacrum with an axially applied, non-rotational force, and anchoring the bone fixation implant in the interior region of the sacrum to fixate the sacral-iliac joint.

2. A method according to claim 1 wherein the bone fixation implant comprises a fusion cage structure.

3. A method according to claim 1 wherein the bone fixation implant comprises an elongated implant structure having a triangular cross section.

4. A method according to claim 1 wherein the insertion path is created in a non-invasive manner without prior removal of cartilage.

5. A 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.

6. The method according to claim 1, wherein the elongated implant structure has a rectilinear cross section at a proximal portion of the elongated implant structure.

7. The method according to claim 6, wherein the proximal portion of the elongated implant structure is configured to engage the cortical bone of the ilium after implantation and resist rotation.

8. A method for the fusion of the sacral-iliac joint between an iliac and a sacrum comprising creating 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, providing a bone fixation implant free of external screw threads, wherein the bone fixation implant comprises an elongated implant structure having a longitudinal axis and a rectilinear cross section transverse to the longitudinal axis and including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure, inserting the bone fixation implant through the postero-lateral insertion path with an axially applied, non-rotational force, and anchoring the bone fixation implant in the interior region of the sacral alae to fixate the sacral-iliac joint.

9. A method according to claim 8 wherein the bone fixation implant comprises a fusion cage structure.

10. A method according to claim 8 wherein the bone fixation implant comprises an elongated implant structure having a rectilinear cross section including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure.

11. A method according to claim 8 wherein the bone fixation implant comprises an elongated implant structure spanning the sacral-iliac joint, the elongated implant structure including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure to accelerate the fusion of the sacral-iliac joint.

12. A method according to claim 8 wherein the insertion path is created in a non-invasive manner without prior removal of cartilage.

13. A method according to claim 8 wherein the insertion path comprises a bore sized approximately at or approximately about an outer maximum dimension of the bone fixation implant.

14. A method for the fusion of the sacral-iliac joint between an iliac and a sacrum comprising creating a lateral insertion path laterally through the ilium, through the sacral-iliac joint, and into the sacrum, providing a bone fixation implant free of external screw threads, wherein the bone fixation implant comprises an elongated implant structure having a longitudinal axis and a cross section 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, inserting the bone fixation implant through the insertion path laterally from the ilium, through the sacral-iliac joint, and into the sacrum with an axially applied, non-rotational force, and anchoring the bone fixation implant in the interior region of the sacrum to fixate the sacral-iliac joint.

15. The method of claim 14, wherein the elongated implant further comprises a cross-section transverse the longitudinal axis that is defined by at least two apices joined together by at least two sides.

16. The method of claim 14, wherein the elongated implant further comprises a cross-section transverse the longitudinal axis that is defined by at least three apices joined together by at least three sides.

17. A method for the fusion of the sacral-iliac joint between an iliac and a sacrum comprising creating 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, providing a bone fixation implant free of external screw threads, wherein the bone fixation implant comprises an elongated implant structure having a longitudinal axis and a cross section 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, inserting the bone fixation implant through the postero-lateral insertion path with an axially applied, non-rotational force, and anchoring the bone fixation implant in the interior region of the sacral alae to fixate the sacral-iliac joint.