Systems and methods for the fixation or fusion of bone

• US 9,743,969 B2
• Filed: 04/04/2014
• Issued: 08/29/2017
• 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): Negrellirodrigue, Christina
• Application Number:
  US14/245,759
• Publication Number:
  US 20140222150A1
• Time in Patent Office: 1,243 Days
• Field of Search: 606246-279, 606 62, 606 86 A, 606 86 R, 606 99, 606104, 606105
• 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 17/68 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 17/846 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 17/8625 Shanks, i.e. parts contacting bone tissue
• 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 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• 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

A joint between two bone segments is fused by passing an elongated, rectilinear bone fusion device over a guide pin across the joint and into tight engagement within bores formed in the bone segments, to thereby restrict movement of the elongated bone fusion device across the joint. The elongated, rectilinear bone fusion device also provides bony in-growth within the bores along the exterior surface of the bone fusion device.

Claims

1. A method comprising:

identifying a bone site comprising a first bone segment, a second bone segment, and a joint between the first and second bone segments;

providing an elongated bone fusion device having a longitudinal axis and a rectilinear cross section transverse to the longitudinal axis and including an exterior surface treated to provide bony in-growth;

forming a bore having a longitudinal axis in the first bone segment;

forming a bore having a longitudinal axis in the second bone segment that faces the bore in the first bone segment across the joint, the bores in the first and second segments each being non-parallel to the joint and having a rectilinear cross-sectional profile sized and configured to tightly engage the exterior surface of the elongated bone fusion device, wherein the rectilinear cross-sectional profile of each bore is transverse to the longitudinal axis of each bore; and

fusing the joint by inserting the elongated bone fusion device across the joint and into tight engagement within the bores of the first and second bone segments, to thereby restrict movement of the elongated bone fusion device across the joint and provide bony in-growth within the bores along the exterior surface of the bone fusion device.

2. A method according to claim 1, wherein the rectilinear cross section of the elongated bone fusion device comprises a square.

3. A method according to claim 1, wherein the rectilinear cross section of the elongated bone fusion device comprises a rectangle.

4. A method according to claim 1, wherein the rectilinear cross section of the elongated bone fusion device comprises a triangle.

5. A method according to claim 1, wherein forming the bore in the first bone segment comprises drilling a pilot bore with a drill bit.

6. A method according to claim 1, wherein inserting the elongated bone fusion device across the joint comprises tapping the bone fusion device.

7. A method comprising:

identifying a bone site comprising a first bone segment, a second bone segment, and a joint between the first and second bone segments;

providing an elongated bone fusion device 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;

forming a bore having a longitudinal axis in the first bone segment;

forming a bore having a longitudinal axis in the second bone segment that faces the bore in the first bone segment across the joint, the bores in the first and second segments each being non-parallel to the joint and having a cross-sectional profile defined by at least one apex sized and configured to tightly engage the exterior surface of the elongated bone fusion device, wherein the cross-sectional profile defined by at least one apex of each bore is transverse to the longitudinal axis of each bore; and

fusing the joint by inserting the elongated bone fusion device across the joint and into tight engagement within the bores of the first and second bone segments, to thereby restrict movement of the elongated bone fusion device across the joint and provide bony in-growth within the bores along the exterior surface of the bone fusion device.

8. A method according to claim 7, wherein the cross sectional profile is defined by three apices.

9. A method according to claim 7, wherein the cross sectional profile is defined by four apices.

10. A method according to claim 7, wherein inserting the elongated bone fusion device across the joint comprises tapping the bone fusion device.