Systems and methods for the fixation or fusion of bone

• US 9,561,063 B2
• Filed: 04/01/2011
• Issued: 02/07/2017
• 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:
  US13/078,530
• Publication Number:
  US 20110184478A1
• Time in Patent Office: 2,139 Days
• Field of Search: 606246-279, 606/62, 606/86.R, 606/95, 606/105
• US Class Current: 1/1
• 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 joint fusion device comprising:

an elongated bone fusion device having a proximal end, a distal end, a longitudinal axis and a substantially triangular cross section transverse to the longitudinal axis and free of external screw threads and being sized and configured for placement in association with and non-parallel to a joint between individual first and second bone segments in response to an axially applied, non-rotational force, the elongated bone fusion device including a lumen extending through the length of the elongated bone fusion device from the proximal end to the distal end and oriented parallel to the longitudinal axis to accommodate passage over a guide pin during placement and an exterior surface treated to provide bony in-growth upon placement, wherein the exterior surface has a rough surface texture, wherein the distal end includes a beveled distal tip.

2. A device according to claim 1, wherein the elongated bone fusion device is formed from one or more materials selected from the group consisting of metal, ceramic and glass.

3. A device according to claim 2, wherein the metal is selected from the group consisting of titanium, titanium alloys, tantalum, chrome cobalt and steel.

4. A device according to claim 1, wherein the rough surface texture is porous.

5. A device according to claim 1, wherein the rough surface texture is formed from an open mesh configuration.

6. A device according to claim 1, wherein the rough surface texture is formed from a beaded configuration.

7. A device according to claim 1, wherein the rough surface texture is formed from a trabecular configuration.

8. A device according to claim 1, wherein the exterior surface comprises at least one fenestration with an opening located on the exterior surface.

9. A device according to claim 1, wherein the elongated bone fusion device is sized to be the same cross-sectional size as a bore traversing the joint from the first bone segment to the second bone segment.

10. A device according to claim 1, wherein the elongated bone fusion device is sized to be slightly larger than the dimensions of a bore traversing the joint from the first bone segment to the second bone segment.

11. The device of claim 1, wherein the substantially triangular cross section transverse to the longitudinal axis remains substantially the same size along a majority of the length of the implant.

12. The device of claim 1, wherein the elongate bone fusion device is substantially straight from the proximal end to the distal end along the length of elongate bone fusion device.

13. A joint fusion device comprising:

an elongated bone fusion device having a proximal end, a distal end, a longitudinal axis and a cross section transverse to the longitudinal axis that is defined by at most three rounded apices, the elongated bone fusion device free of external screw threads and being sized and configured for placement in association with and non-parallel to a joint between individual first and second bone segments in response to an axially applied, non-rotational force, the elongated bone fusion device including a lumen extending through the length of the elongated bone fusion device from the proximal end to the distal end and oriented parallel to the longitudinal axis to accommodate passage over a guide pin during placement and an exterior surface treated to provide bony in-growth upon placement, wherein the exterior surface has a rough surface texture, wherein the distal end includes a beveled distal tip, wherein the elongated bone fusion device comprises a cross section transverse to the longitudinal axis that is defined by three rounded apices joined together by three sides.

14. The device of claim 13, wherein the three sides are curvilinear.

15. A joint fusion device comprising:

an elongated bone fusion device having a proximal end, a distal end, a longitudinal axis and a substantially triangular cross section transverse to the longitudinal axis and free of external screw threads and being sized and configured for placement in association with and non-parallel to a joint between individual first and second bone segments in response to an axially applied, non-rotational force, the elongated bone fusion device including a lumen extending through the length of the elongated bone fusion device from the proximal end to the distal end and oriented parallel to the longitudinal axis to accommodate passage over a guide pin during placement and an exterior surface treated to provide bony in-growth upon placement, wherein the exterior surface has a rough surface texture, wherein the lumen comprises internal screw threads located at least one end of the lumen.