Methods and devices for treating fractured and/or diseased bone using an expandable stent structure

• US 20070055285A1
• Filed: 09/27/2006
• Published: 03/08/2007
• Est. Priority Date: 08/14/1998
• Status: Active Grant

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Boucher, Ryan, Follmer, Marialulu, Layne, Richard, Basista, Joseph, Osorio, Reynaldo, Talmadge, Karen
• Granted Patent: US 8,226,717 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 with hole for different instruments A61B2017/22072
• 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 for prostheses A61F2210/0014
• 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 established into a selected bone having an interior volume occupied, at least in part, by a cancellous bone, e.g., a vertebral body. An expandable stent structure is introduced into the cancellous bone by deployment of a tool through the percutaneous path into the cancellous bone. The expandable stent structure is expanded within cancellous 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 stent structure, and

a second tool sized and configured for passage through the access path to introduce the expandable stent structure into the cancellous bone.

2. A system according to claim 1

further including a tool sized and configured to be introduced through a percutaneous access path for conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

3. A system according to claim 2

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

4. A system according to claim 1

further including a tool sized and configured to be introduced through a percutaneous access path for forming a cavity in the cancellous bone prior to introduction of the expandable stent structure.

5. A system according to claim 4

wherein the tool for forming a cavity comprises at least one of a tamp, a reamer, a hole punch, an expandable body, or an inflatable balloon.

6. A system according to claim 4

further including a tool sized and configured to be introduced through a percutaneous access path for conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

7. A system according to claim 6

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

8. A system according to claim 1

further including a tool sized and configured to be introduced through a percutaneous access path for forming a cavity in the cancellous bone after introduction of the expandable stent structure.

9. A system according to claim 8

wherein the tool for forming a cavity comprises at least one of a tamp, a reamer, a hole punch, an expandable body, or an inflatable balloon.

10. A system according to claim 8

further including a tool sized and configured to be introduced through a percutaneous access path for conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

11. A system according to claim 10

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

12. A system according to claim 1

wherein the expandable stent structure is sized and configured to be left within the cancellous bone upon removal of the second tool.

13. A method comprising

providing a system as defined in claim 1,

manipulating the first tool sized to establish the access path,

manipulating the second tool through the access path to introduce the expandable stent structure into the cancellous bone.

14. A method according to claim 13

further including conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

15. A method according to claim 14

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

16. A method according to claim 13

further including forming a cavity in the cancellous bone prior to introduction of the expandable stent structure.

17. A method according to claim 16

further including conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

18. A method according to claim 17

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

19. A method according to claim 13

further including forming a cavity in the cancellous bone after introduction of the expandable stent structure.

20. A method according to claim 19

further including conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

21. A method according to claim 20

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

22. A method according to claim 13

further including manipulating the second tool to withdraw the second tool through the access path, leaving the expandable stent structure within the cancellous bone.

23. A method comprising

selecting a vertebral body for treatment having a cortical wall enclosing a cancellous bone volume,

providing a system as define in claim 1,

manipulating the first tool sized to establish the access path into the cancellous bone volume, and

manipulating the second tool through the access path to introduce the expandable stent structure into the cancellous bone volume.

24. A method according to claim 23

further including a tool sized and configured to be introduced through a percutaneous access path for conveying a filling material into the cancellous bone volume to occupy the cancellous bone structure with the expandable stent structure.

25. A method according to claim 23

further including manipulating the second tool to withdraw the second tool through the access path, leaving the expandable stent structure within the cancellous bone.

27. 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 stent structure into the cancellous bone by deployment of a tool through the percutaneous path into the cancellous bone; and

expanding the expandable stent structure within cancellous bone.

26. A method according to claim 36

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

28. A method according to claim 27

further including conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

29. A method according to claim 28

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

30. A method according to claim 27

further including forming a cavity in the cancellous bone prior to introduction of the expandable stent structure.

31. A method according to claim 27

further including conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

32. A method according to claim 31

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

33. A method according to claim 27

further including forming a cavity in the cancellous bone after introduction of the expandable stent structure.

34. A method according to claim 33

further including conveying a filling material into the cancellous bone to occupy the cancellous bone with the expandable stent structure.

35. A method according to claim 34

wherein the filling material comprises at least one of a bone cement, curable bio-material, allograft tissue, autograft tissue, an synthetic bone substitute.

36. A method according to claim 27

further including manipulating the second tool to withdraw the second tool through the access path, leaving the expandable stent structure within the cancellous bone.

37. A method according to claim 27

wherein the bone comprises a vertebral body.

38. A method according to claim 37

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