Methods and devices for treating fractured and/or diseased bone using an expandable structure that remains within the bone

• US 20070055284A1
• Filed: 09/27/2006
• Published: 03/08/2007
• Est. Priority Date: 01/26/1994
• Status: Active Grant

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Scholten, Arie, Boucher, Ryan, Follmer, Marialulu, Layne, Richard, Scribner, Robert, Basista, Joseph, Osorio, Reynaldo, Reiley, Mark, Talmadge, Karen
• Granted Patent: US 7,967,827 B2
• Time in Patent Office: Days
• US Class Current: 606/94
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00464 for use with different instruments
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

A percutaneous path is created into a bone having an interior volume occupied, at least in part, by a cancellous bone, e.g., a vertebral body. An expandable structure is introduced into the cancellous bone by deployment of a tool through the percutaneous path into the cancellous bone. The expandable structure is expanded and the tool withdrawn, leaving the expandable structure expanded inside the cancellous bone. Expansion of the expandable structure within cancellous bone can, e.g., compact cancellous bone, and/or create a cavity in cancellous bone, and/or move fractured cortical bone.

Claims

1. A system comprising

a first tool sized and configured to establish an access path through soft tissue to bone having an interior volume occupied, at least in part, by cancellous bone,

an expandable structure sized and configured for expansion in cancellous bone, and

a second tool sized and configured for passage through the access path to introduce into the cancellous bone the expandable structure, which remains within the cancellous bone upon removal of the second tool.

2. A system according to claim 1

wherein the expandable structure comprises a stent.

3. A system according to claim 1

wherein the expandable structure comprises a structure that enlarges by inflation.

4. A system according to claim 1

wherein the expandable structure comprises a balloon.

5. A system according to claim 1

wherein the expandable structure comprises a mesh structure.

6. A system according to claim 1

wherein the expandable structure comprises a bio-absorbable material.

7. A system according to claim 1 further comprising:

a tool sized and configured to introduce a filler material into the cancellous bone.

8. A system according to claim 7

wherein the filler material comprises at least one of a bone filler, a bone cement, a synthetic bone substitute, a bone biomaterial, a hydroxyapatite material, a bone mineral material, a thixotropic material, a curable bio-material, allograft tissue, and autograft tissue.

9. A system according to claim 1 further comprising:

a tool sized and configured to introduce a filler material into the expandable structure to expand the expandable structure.

10. A system according to claim 9

wherein the filler material comprises at least one of a bone filler, a bone cement, a synthetic bone substitute, a bone biomaterial, a hydroxyapatite material, a bone mineral material, a thixotropic material, a curable bio-material, allograft tissue, and autograft tissue.

11. A system according to claim 10, wherein expansion of the expandable structure within cancellous bone compacts cancellous bone.

12. A system according to claim 10, wherein expansion of the expandable structure within cancellous bone creates a cavity in cancellous bone.

13. A system according to claim 10, wherein expansion of the expandable structure within cancellous bone moves fractured cortical bone.

14. A system according to claim 1, wherein expansion of the expandable structure within cancellous bone compacts cancellous bone.

15. A system according to claim 1, wherein expansion of the expandable structure within cancellous bone creates a cavity in cancellous bone.

16. A system according to claim 1, wherein expansion of the expandable structure within cancellous bone moves fractured cortical bone.

17. A method comprising

creating a percutaneous path into a bone having an interior volume occupied, at least in part, by a cancellous bone;

introducing an expandable structure into the cancellous bone by deployment of a tool through the percutaneous path into the cancellous bone; and

expanding the expandable structure;

withdrawing the tool, leaving the expandable structure expanded inside the cancellous bone.

18. A method according to claim 17

wherein the expandable structure comprises a stent.

19. A method according to claim 17

wherein the expandable structure comprises a structure that enlarges by inflation.

20. A method according to claim 17

wherein the expandable structure comprises a balloon.

21. A method according to claim 17

wherein the expandable structure comprises a mesh structure.

22. A method according to claim 17

wherein the expandable structure comprises a bio-absorbable material.

23. A method according to claim 17 further comprising:

a tool sized and configured to introduce a filler material into the cancellous bone.

24. A method according to claim 23

wherein the filler material comprises at least one of a bone filler, a bone cement, a synthetic bone substitute, a bone biomaterial, a hydroxyapatite material, a bone mineral material, a thixotropic material, a curable bio-material, allograft tissue, and autograft tissue.

25. A method according to claim 17, wherein expansion of the expandable structure within cancellous bone compacts cancellous bone.

26. A method according to claim 17, wherein expansion of the expandable structure within cancellous bone creates a cavity in cancellous bone.

27. A method according to claim 17, wherein expansion of the expandable structure within cancellous bone moves fractured cortical bone.

28. A method according to claim 17

wherein the bone comprises a vertebral body.

29. A method according to claim 28

wherein the percutaneous path is established through a pedicle of the vertebral body.

30. A method comprising

creating a percutaneous path into a bone having an interior volume occupied, at least in part, by a cancellous bone;

introducing an expandable structure into the cancellous bone by deployment of a tool through the percutaneous path into the cancellous bone;

expanding the expandable structure by introducing a filler material into the structure within the cancellous bone, and

withdrawing the tool, leaving the structure and filler material inside the cancellous bone.

31. A method according to claim 30

wherein the expandable structure comprises a balloon.

32. A method according to claim 30

wherein the expandable structure comprises a mesh structure.

33. A method according to claim 30

wherein the expandable structure comprises a bio-absorbable material.

34. A method according to claim 30

wherein the filler material comprises at least one of a bone filler, a bone cement, a synthetic bone substitute, a bone biomaterial, a hydroxyapatite material, a bone mineral material, a thixotropic material, a curable bio-material, allograft tissue, and autograft tissue.

35. A method according to claim 30, wherein expansion of the expandable structure within cancellous bone compacts cancellous bone.

36. A method according to claim 30, wherein expansion of the expandable structure within cancellous bone creates a cavity in cancellous bone.

37. A method according to claim 30, wherein expansion of the expandable structure within cancellous bone moves fractured cortical bone.

38. A method according to claim 30

wherein the bone comprises a vertebral body.

39. A method according to claim 38

wherein the percutaneous path is established through a pedicle of the vertebral body.