Systems and methods for the fixation or fusion of bone using compressive implants

• US 8,734,462 B2
• Filed: 03/05/2013
• Issued: 05/27/2014
• Est. Priority Date: 08/09/2004
• Status: Active Grant

• Current Assignee: SI-Bone, Incorporated
• Original Assignee: SI-Bone, Incorporated
• Inventors: Reiley, Mark A., Lerman, Justin, Mauldin, Richard G.
• Primary Examiner(s): Hoffman, Mary
• Assistant Examiner(s): NEGRELLIRODRIGUE, CHRISTINA
• Application Number:
  US13/786,037
• Publication Number:
  US 20130184769A1
• Time in Patent Office: 448 Days
• Field of Search: 606246-248, 606300-321, 606/95, 606/96, 606/99, 606/104, 606/105, 606/279, 623 1711- 1716, 128/898
• US Class Current: 606/105
• 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

First and second bone segments separated by a fracture line or joint can be fixated or fused by creating an insertion path through the first bone segment, through the fracture line or joint, and into the second bone segment. An anchor body is introduced through the insertion path. The distal end of the anchor body is anchored in the interior region of the second bone segment. An elongated implant structure is passed over the anchor body to span the fracture line or joint between the bone segments. The proximal end of the anchor body is anchored to an exterior region of the first bone segment to place, in concert with the anchored distal end, the anchor body in compression, to thereby compress and fixate the bone segments relative to the fracture line or joint.

Claims

1. An assembly for the fixation or fusion of bone structures comprising first and second bone segments separated by a fracture line or joint, the assembly comprising

an anchor body sized and configured to be introduced into the first and second bone segments and transversely across the fracture line or joint, the anchor body having a distal end located in an interior region of the second bone segment;

a proximal end located outside an exterior region of the first bone segment; and

an intermediate region spanning the fracture line or joint between the first and second bone segments,

a distal anchor secured to the interior region of the second bone segment and reversibly affixed to the distal end of the anchor body to anchor the distal end in the second bone segment,

a proximal anchor secured to the exterior region of the first bone segment and affixed to the proximal end of the anchor body to place, in concert with the distal anchor, the anchor body in compression to compress and fixate the bone segments relative to the fracture line or joint, and

an elongated implant structure having a lumen extending therethrough and configured to be disposed coaxially over the intermediate region of the anchor body and between the proximal anchor and distal anchor and transversely spanning the fracture line or joint between the bone segments, 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 fixation or fusion of the first and second bone segments held in compression and fixated by the anchor body.

2. An assembly according to claim 1 wherein the distal anchor comprises an externally threaded screw.

3. An assembly according to claim 2 wherein the distal end of the anchor body is threaded to engage threads formed in an interior bore of the screw.

4. An assembly according to claim 1 wherein the distal anchor comprises an interference fit between the distal end of the anchor body and bone within the interior region of the second bone segment.

5. An assembly according to claim 1 wherein the distal anchor comprises an adhesive applied between the distal end of the anchor body and bone within the interior region of the second bone segment.

6. An assembly according to claim 1 wherein the distal anchor comprises a plate having bone cutting edges rotatable into engagement with bone.

7. An assembly according to claim 1 wherein the distal anchor comprises a plate rotatable into a bone-gripping position in response to rotation of the distal region of the anchor body.

8. An assembly according to claim 1 wherein the proximal anchor comprises a nut.

9. An assembly according to claim 8 wherein the proximal anchor further includes a washer between the nut and the exterior surface of the first bone segment.

10. An assembly according to claim 8 wherein the proximal end of the anchor body is threaded to engage threads formed in an interior bore of the nut.

11. An assembly according to claim 10 wherein the proximal anchor includes a washer between the nut and the exterior surface of the first bone segment.

12. An assembly according to claim 1 wherein the implant structure has a generally curvilinear cross section.

13. An assembly according to claim 1 wherein the implant structure has a generally rectilinear cross section.

14. An assembly according to claim 1 wherein the implant structure has a generally triangular cross section.

15. An assembly according to claim 1 wherein the implant structure includes a tapered region.

16. An assembly according to claim 1 wherein the implant structure includes a tapered proximal region.

17. An assembly according to claim 1 wherein the cross section of the implant structure is larger nearer the proximal anchor than near the distal anchor.

18. An assembly according to claim 1 wherein the implant structure includes exterior bone-gripping surfaces.

19. An assembly according to claim 1 wherein the bony in-growth or through-growth region of the implant structure includes a porous plasma spray coating.

20. An assembly according to claim 1 wherein the proximal anchor in concert with the distal anchor places the implant structure in compression to bring the bony in-growth or through-growth region into intimate contact with bone within the first and segments bone segments.

21. An assembly according to claim 1 wherein the anchor body comprises a cylindrical pin or rod shaped geometry.

22. A method for the fixation or fusion of bone structures comprising:

identifying first and second bone segments separated by a fracture line or joint,

creating an insertion path through the first bone segment, transversely through the fracture line or joint, and into the second bone segment,

providing an anchor body sized and configured to be introduced through the insertion path into the first and second bone segments and transversely across the fracture line or joint, the anchor body having a distal end sized and configured to be located in an interior region of the second bone segment;

a proximal end sized and configured to be located outside an exterior region of the first bone segment; and

an intermediate region sized and configured to span the fracture line or joint between the first and second bone segments,

providing an elongated implant structure sized and configured to be passed coaxially over the anchor body to span the fracture line or joint between the bone segments, the elongated implant structure including an exterior surface region treated to provide bony in-growth or through-growth along the implant structure,

introducing the anchor body through the insertion path from the first bone segment, through the fracture line or joint, and into the second bone segment,

anchoring the distal end of the anchor body in the interior region of the second bone segment,

passing the elongated implant structure coaxially over the anchor body to transversely span the fracture line or joint between the bone segments, and

anchoring the proximal end of the anchor body to an exterior region of the first bone segment to place, in concert with the anchored distal end, the anchor body in compression to compress and fixate the bone segments relative to the fracture line or joint, whereby the bony in-growth or through-growth region of the implant structure accelerates the fixation or fusion of the first and second bone segments held in compression and fixated by the anchor body.

23. A method according to claim 22 wherein the distal end of the anchor body is anchored in the interior region of the second bone segment by an interference fit between the distal end and the insertion path.

24. A method according to claim 22 wherein the distal end of the anchor body is anchored in the interior region of the second bone segment by an adhesive.

25. A method according to claim 22 wherein anchoring the distal end of the anchor body includes implanting an externally threaded screw in the interior region of the second bone segment, and affixing the distal end of the anchor body to the screw.

26. A method according to claim 22 wherein anchoring the proximal end of the anchor body includes threading an anchor nut to the proximal end of the anchor body.

27. A method according to claim 22 wherein anchoring the proximal end of the anchor body includes threading an anchor nut with a washer to the proximal end of the anchor body.

28. A method according to claim 22 wherein the insertion path and the implant structure have generally concentric curvilinear cross sections.

29. A method according to claim 22 wherein the insertion path and the implant structure have generally concentric rectilinear cross sections.

30. A method according to claim 22 wherein the insertion path and the implant structure have generally concentric triangular cross sections.