Methods and devices for stenting or tamping a fractured vertebral body

• US 20070088436A1
• Filed: 11/29/2005
• Published: 04/19/2007
• Est. Priority Date: 09/29/2005
• Status: Abandoned Application

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Parsons, Matthew, Voellmicke, John, Dooris, Andrew, O'Neil, Michael
• Application Number:
  US11/289,252
• Publication Number:
  US 20070088436A1
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30476 locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/445 Intervertebral disc tissue harvest sites
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

Intravertebral bone stents and tamps made from shape memory metal

Claims

1. An intravertebral bone stent comprising a tubular member comprising a shape memory material.

2. The stent of claim 1 wherein the shape memory material has a martinsitic M→

austentic A phase change between 22°

C. and 37°

C.

3. The stent of claim 1 wherein the shape memory material has a superelastic characteristic between 22°

C. and 37°

C.

4. The stent of claim 1 wherein the tubular member is a mesh.

5. The stent of claim 1 wherein the shape memory material is selected from the group consisting of a metal and a polymer.

6. A method of stabilizing a fracture vertebral body, comprising the steps of:

a) providing an intravertebral bone stent comprising a tubular member comprising a shape memory material in a collapsed state,

b) delivering the stent into the fractured vertebral body, and

c) expanding the stent to stabilize the fractured vertebral body.

7. The method of claim 6 wherein the shape memory material has a martinsitic M→

austentic A phase change between 22°

C. and 37°

C., and the expansion of the stent occurs upon body heating.

8. The method of claim 6 wherein the shape memory material has a superelastic characteristic between 22°

C. and 37°

C., the stent is delivered through a cannula, and the expansion of the stent occurs as the stent emerges from the cannula.

9. The method of claim 6 wherein the tubular member is a mesh.

10. The method of claim 6 wherein the shape memory material is selected from the group consisting of a metal and a polymer.

11. The method of claim 6 wherein the expansion of the stent creates a cavity, and further comprising the steps of:

d) flowing a flowable material into the cavity.

12. The method of claim 11 wherein the flowable material is selected from the group consisting of a bone cement and a bone growth agent.

13. The method of claim 12 wherein the flowable material is a bone growth agent.

14. The method of claim 13 wherein the bone growth agent comprises a growth factor.

15. The method of claim 13 wherein the bone growth agent comprises a porous matrix.

16. The method of claim 13 wherein the bone growth agent comprises viable cells.

17. An intravertebral bone tamp comprising:

a) a cannula having a throughbore, and

b) an expansion device disposed within the cannula, wherein the expansion device comprises a distal tubular member comprising a shape memory material having a martinsitic M→

austentic A phase change between 22°

C. and 37°

C. and a proximal rod.

18. The tamp of claim 17 wherein the tubular member is a mesh.

19. The tamp of claim 17 wherein the tubular member is solid.

20. The tamp of claim 17 wherein the shape memory material is selected from the group consisting of a metal and a polymer.

21. A method of stabilizing a fractured vertebral body, comprising the steps of:

a) providing an intravertebral bone tamp comprising a shape memory material having a martinsitic M→

austentic A phase change between 22°

C. and 37°

C. in a collapsed state,

b) delivering the tamp into the fractured vertebral body in the collapsed state, and

c) heating the memory metal material to expand the tamp to stabilize the fractured vertebral body.

22. The method of claim 21 wherein the tamp has a distal tubular member having a mesh shape.

23. The method of claim 21 wherein the shape memory material is selected from the group consisting of a metal and a polymer.

24. The method of claim 21 wherein the expansion of the tamp creates a cavity, and further comprising the steps of:

d) flowing a flowable material into the cavity.

25. The method of claim 24 wherein the flowable material is selected from the group consisting of a bone cement and a bone growth agent.

26. The method of claim 25 wherein the flowable material is a bone growth agent.

27. The method of claim 26 wherein the bone growth agent comprises a growth factor.

28. The method of claim 26 wherein the bone growth agent comprises a porous matrix.

29. The method of claim 26 wherein the bone growth agent comprises viable cells.

30. The method of claim 21 further comprising the steps of:

d) removing the tamp from the vertebral body.

31. A method of stabilizing a fracture vertebral body, comprising the steps of:

a) providing a plurality of implants comprising a shape memory material in a collapsed state,

b) delivering the plurality of implants through a cannula into the fractured vertebral body, and

c) expanding the plurality of implants to stabilize the fractured vertebral body.

32. The method of claim 31 wherein the shape memory material is a shape memory metal.

33. The method of claim 31 wherein the plurality of implants have a collapsed shape selected from the group consisting of a sphere, a football, a coil, a cylinder, an ellipsoid, and a crumpled ball of wire.

34. The method of claim 31 wherein the plurality of implants are sequentially inserted into the fractured vertebral body.

35. The method of claim 31 wherein the plurality of implants are expanded through heat activated phase transformation.

36. The method of claim 31 wherein the plurality of implants are expanded through superelastic deformation.

37. The method of claim 31 wherein the plurality of implants are expanded to locally compact tissue and to create a network of small voids in the vertebral body.

38. The method of claim 37 further comprising the step of:

d) flowing a flowable material into the network of small voids.

39. The method of claim 38 wherein the flowable material is selected from the group consisting of a bone cement and a bone growth agent.

40. The method of claim 38 wherein the flowable material is a bone growth agent.

41. The method of claim 40 wherein the bone growth agent comprises a growth factor.

42. The method of claim 40 wherein the bone growth agent comprises a porous matrix.

43. The method of claim 40 wherein the bone growth agent comprises viable cells.

44. The method of claim 37 further comprising the step of:

d) ravaging the network of small voids.

45. An intervertebral bone stent comprising:

a) a rod having a distal end portion, a proximal end portion and a threaded intermediate portion, and

b) a deformable shell having an upper wall, a lower wall, a distal intermediate wall located between the upper and lower walls, and a proximal threaded lumen

wherein the distal end portion of the rod is attached to the intermediate wall of the deformable shell, and

wherein the threaded intermediate portion of the rod is received in the threaded lumen.

46. An intervertebral bone stent comprising:

a) a rod having a distal end portion forming a proximal shoulder, a proximal end portion having an enlarged head forming a distal shoulder, and a threaded intermediate shaft portion;

b) a threaded nut having a distal face, the nut threadably received upon the threaded intermediate shaft portion of the rod; and

c) a deformable shell having an upper wall and a lower wall, each wall having a proximal end and a distal end,

wherein the proximal end portion of each wall of the deformable shell bears against the distal face of the nut, and

wherein the distal end portion of each wall of the deformable shell bears against the proximal shoulder of the rod.

47. An intervertebral bone stent comprising:

a) a tube having an outer surface, and inner threaded surface, a throughbore, and upper and lower slots extending from the outer surface to the throughbore, and a distal end shoulder radially extending from the outer surface;

b) a threaded nut having a distal face, the nut threadably received upon the threaded inner surface of the tube;

c) a plate having an upper end portion, a lower end portion, and an intermediate portion, the upper end of the plate extending from the upper slot and the lower end of the plate extending from the lower slot and

d) deformable upper and lower walls, each wall having a proximal end and a distal end,

wherein the distal face of the threaded nut abuts the intermediate portion of the plate,

wherein the proximal end portion of the upper wall abuts the upper end portion of the plate,

wherein the proximal end portion of the lower wall abuts the lower end portion of the plate,

wherein the distal end portion of each wall abuts the distal end shoulder.

48. An intervertebral bone stent comprising:

a) a rod having a distal end portion forming a proximal shoulder, an intermediate portion, and a proximal end portion,

b) a tube received upon the rod, the tube having an unslitted distal end and a plurality of intermediate longitudinal slits forming a plurality of collapsible walls having a distal end,

wherein the distal end portion of the rod extends from the tube, and

wherein the unslitted distal end of the tube bears against the proximal shoulder of the distal end portion of the rod.

49. An intervertebral bone stent comprising:

a) a reversibly expanding structure containing multiple linkages capable of transitioning the structure from a collapsed shape to an expanded shape.

50. The stent of claim 49 wherein the reversibly expanding structure has an inner void, and further comprising:

b) a membrane membrane located within the inner void.

51. The stent of claim 49 wherein the reversibly expanding structure has an inner void, and further comprising:

b) a turnbuckle located within the inner void.

52. An intravertebral stent, comprising:

a) a turnbuckle comprising a shaft having a first threaded end portion and a second oppositely threaded end portion,

b) a first nut threadably received upon the first threaded end portion,

c) a second nut threadably received upon the second oppositely threaded end portion,

d) an expandable structure comprising a plurality of struts and means for connecting the struts in a cooperative pattern, the struts including a first and second end struts,

wherein the first end strut bears against the first nut and the second end strut bears against the second nut.

53. An intervertebral bone stent comprising:

a) a first hemi-tube having an inside surface, an outside surface and a first longitudinal hinge,

b) a second hemi-tube having an inside surface, an outside surface and a second longitudinal hinge, the inside surface of the second hemi-tube opposing the inside surface of the first hemi-tube to form an inner bore between the two hemi-tubes,

c) a cam located within the inner bore.

54. The stent of claim 53 wherein the cam is substantially oval.