Implants and methods for treating bone

• US 7,621,952 B2
• Filed: 06/07/2005
• Issued: 11/24/2009
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Shadduck, John H., Truckai, Csaba
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/146,893
• Publication Number:
  US 20060089715A1
• Time in Patent Office: 1,631 Days
• Field of Search: 623/16.11, 623 1711- 1716, 606/61
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

An orthopedic implant comprising a deformable, expandable implant body configured for treating abnormalities in bones, such as compression fractures of vertebra, necrosis of femurs and the like. An exemplary implant body comprises a small cross-section threaded element that is introduced into a bone region and thereafter is expanded into a larger cross-section, monolithic assembly to provide a bone support. In one embodiment, the implant body is at least partly fabricated of a magnesium alloy that is biodegradable to allow for later tissue ingrowth.

Claims

1. An expandable implant, comprising:

an elongated body configured for insertion into or adjacent a bone in a collapsed configuration and moveable into an expanded configuration to support the bone, the body comprising a plurality of similarly shaped body segments aligned with each other along an axis in the collapsed configuration, at least one of the body segments insertable along the axis into a second of the body segments so as to helically unwind the second body segment in a direction outward from the axis to thereby controllably move the body into the expanded configuration, each of the body segments comprising at least one deformable element wound about the axis along the length of the body segment from a proximal end to a distal end of the body segment, said at least one element configured to unwind outward from the axis upon the introduction of said at least one body segment into the second body segment

2. An expandable implant as in claim 1, wherein the at least one element is at least partly of a metal.

3. An expandable implant as in claim 2, wherein the metal includes at least one of titanium, tantalum or a magnesium alloy.

4. An expandable implant as in claim 1, wherein the at least one element is at least partly of a polymer.

5. An expandable implant as in claim 4, wherein the polymer is at least one of biodegradable, bioabsorbable or bioexcretable.

6. An expandable implant as in claim 1, wherein the plurality of body segments are configured for axial segment-to-segment insertion to thereby radially expand the elongated body.

7. An expandable implant as in claim 6, wherein the body includes from 2 to 10 body segments.

8. An expandable implant as in claim 6, wherein each of the body segments has a spiral thread surface.

9. An expandable implant as in claim 8, wherein the body segments have a common right-hand or left-hand spiral thread surface.

10. An expandable implant as in claim 8, wherein body segments have different right-hand and left-hand surface spiral thread surfaces.

11. An expandable implant as in claim 1, wherein the body has an open cell structure.

20. The expandable implant of claim 1, wherein the elongated body in the collapsed configuration has a cross-section generally perpendicular to the axis of about 4 mm.

21. The expandable implant of claim 1, wherein the elongated body in the expanded configuration has a cross-section generally perpendicular to the axis of between about 12 mm and about 16 mm.

22. The implant of claim 1, wherein the elongated body is configured for insertion in an intervertebral space.

23. The implant of claim 1, wherein the plurality of similarly shaped body segments aligned with each other along the axis in the collapsed configuration are coupled together via break-away joints.

30. The implant of claim 1, wherein each body segment comprises a plurality of elements wound about the axis, said plurality of elements configured to unwind upon the introduction of said at least one body segment into the second body segment.

12. A method of treating or prophylactically preventing a fracture of a bone comprising:

introducing into a bone a first implant body segment comprising a deformable helical segment extending about an axis of the first implant body segment, the deformable helical segment being expandable in a direction generally orthogonal to the axis, at least a portion of the deformable helical element contacting the bone; and

introducing at least two additional implant body segments into the interior of the first body segment to thereby helically unwind the helical segment of the first implant body segment outward from the axis to radially expand the first implant body segment in a direction perpendicular to the axis to support the bone.

13. The method of claim 12, wherein introducing the implant body segments displaces cancellous bone.

14. The method of claim 12, wherein introducing the implant body segments moves cortical bone.

15. The method of claim 12, wherein the bone is a vertebra.

16. The method of claim 14, wherein introducing the implant body segments at least partially restores vertebral height.

24. The method of claim 12, wherein the at least two additional implant body segments are deformable helical segments.

25. The method of claim 12, wherein helically deforming the helical segment of the first implant body comprises demating and spacing apart helically-mated elements of the helical segment.

26. The method of claim 12, wherein introducing the at least two additional implant body segments into the first body segment comprises breaking a break-away joint between the additional implant body segments and the first body segment.

17. A method for treating an abnormality in a bone comprising:

introducing an implant body into a bone wherein the implant body includes a biodegradable magnesium alloy expanding the implant body within bone, wherein expanding the implant body comprises axially inserting at least two implant segments into a third implant segment to radially expand the third implant segment outward from the axis, wherein radially expanding the third implant segment comprises helically deforming the third implant segment; and

allowing the magnesium alloy to biodegrade thereby creating space for tissue ingrowth.

18. The method of claim 17, wherein the implant body is deformable and further including the step of radially expanding the deformable implant body.

19. The method of claim 17, wherein the implant body is configured for implantation in a vertebra, and introducing the implant body into a bone includes introducing substantially the entire implant body into a vertebra.

27. An expandable implant insertable into a vertebra, comprising:

an elongated body configured for insertion into a vertebral body along an axis in a collapsed configuration and moveable into an expanded configuration, the body defined by at least three similarly shaped radially deformable segments aligned end-to-end with each other, at least a first and a second segment axially insertable into a third segment such that an outer surface of the first segment helically contacts an inner surface of the third segment to thereby untwist the third segment and expand the body radially outward from the axis.

28. The implant of claim 27, wherein each of the deformable segments comprises a plurality of dematable helically-mated elements intertwined with each other about the axis.

29. The implant of claim 27, wherein each of the deformable segments comprises a spiral thread surface on an outer surface of the deformable segment.