Systems and methods for the fixation or fusion of bone

• US 9,820,789 B2
• Filed: 09/16/2014
• Issued: 11/21/2017
• 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): WOODALL, NICHOLAS W
• Application Number:
  US14/488,144
• Publication Number:
  US 20150005832A1
• Time in Patent Office: 1,162 Days
• 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 stem-like bone fixation device allows for bony in-growth on its surface and across fracture fragments or between bones that are to be fused.

Claims

1. A method for the fixation or fusion of a first bone segment to a second bone segment across a joint, the method comprising:

providing an elongate metal implant having a proximal end, a distal end, a longitudinal axis, an external screw thread, and a lumen extending through the elongate implant along the longitudinal axis, wherein the elongate implant has a tapered distal end and a first fenestration positioned on a middle portion of elongate implant such that the first fenestration is offset from both the distal end and the proximal end;

inserting the elongate implant through the first bone segment and across the joint and into the second bone segment such that the elongate implant traverses the joint at an oblique angle;

providing a second elongate metal implant having a proximal end, a distal end, a longitudinal axis, an external screw thread, and a lumen extending through the second elongate implant along the longitudinal axis of the second elongate implant, wherein the second elongate implant has a tapered distal end; and

inserting the second elongate implant through the first bone segment and across the joint and into the second bone segment;

wherein the second elongate implant is inserted across the joint at an oblique angle.

2. The method of claim 1, wherein the first fenestration is oblong and oriented parallel to the longitudinal axis.

3. The method of claim 1, wherein the elongate implant further comprises a second fenestration sized and shaped like the first fenestration and positioned opposite the first fenestration such that an opening is formed completely through the elongate implant.

4. The method of claim 1, wherein the external screw threads are located on a distal portion of the elongate implant.

5. The method of claim 4, wherein the step of inserting the elongate implant comprises screwing the elongate implant through the first bone segment and across the joint and into the second bone segment.

6. The method of claim 1, wherein the elongate implant is coated with a material that promotes bony in-growth.

7. The method of claim 6, wherein the material is hydroxyapatite.

8. The method of claim 1, further comprising inserting a guide pin through the first bone segment and across the joint and into the second bone segment, wherein the step of inserting the elongate implant comprises inserting the elongate implant over the guide pin.

9. The method of claim 8, further comprising inserting a cannulated drill bit over the guide pin and drilling a bore through the first bone segment and across the joint and into the second bone segment.

10. The method of claim 9, wherein the bore is the same cross-sectional dimension as the implant.

11. The method of claim 9, wherein the bore has a smaller cross-sectional dimension than the implant.

12. The method of claim 1, wherein the second elongate implant has a fenestration positioned on a middle portion of second elongate implant such that the fenestration of the second elongate implant is offset from both the distal end and the proximal end of the second elongate implant.

13. A method for the fixation or fusion of a first bone segment to a second bone segment across a joint, the method comprising:

providing an elongate metal implant having a proximal end, a distal end, a longitudinal axis, an external screw thread, and a lumen extending through the elongate implant along the longitudinal axis, wherein the elongate implant has a tapered distal end and a first fenestration positioned on a middle portion of elongate implant such that the first fenestration is offset from both the distal end and the proximal end;

inserting the elongate implant through the first bone segment and across the joint and into the second bone segment such that the elongate implant traverses the joint at an oblique angle;

providing a second elongate metal implant having a proximal end, a distal end, a longitudinal axis, an external screw thread, and a lumen extending through the second elongate implant along the longitudinal axis of the second elongate implant, wherein the second elongate implant has a tapered distal end; and

inserting the second elongate implant through the first bone segment and across the joint and into the second bone segment;

wherein the second elongate implant is inserted across joint at substantially a right angle.

14. A method for the fixation or fusion of a first bone segment to a second bone segment across a joint, the method comprising:

providing an elongate metal implant having a proximal end, a distal end, a longitudinal axis, and an external screw thread, wherein the elongate implant has a tapered distal end and a first fenestration positioned on a middle portion of elongate implant such that the first fenestration is offset from both the distal end and the proximal end;

inserting the elongate implant through the first bone segment and across the joint and into the second bone segment such that the elongate implant traverses the joint at an oblique angle;

providing a second elongate metal implant having a proximal end, a distal end, a longitudinal axis, and an external screw thread, wherein the second elongate implant has a tapered distal end; and

inserting the second elongate implant through the first bone segment and across the joint and into the second bone segment.

15. The method of claim 14 , wherein the second elongate implant is inserted across the joint at an oblique angle.

16. The method of claim 14 , wherein the second elongate implant is inserted across joint at substantially a right angle.