IMPLANTABLE DEVICES AND METHODS FOR TREATING MICRO-ARCHITECTURE DETERIORATION OF BONE TISSUE

• US 20070067034A1
• Filed: 08/30/2006
• Published: 03/22/2007
• Est. Priority Date: 08/31/2005
• Status: Abandoned Application

• Current Assignee: SpineAlign Medical, Inc.
• Original Assignee: SpineAlign Medical, Inc.
• Inventors: Chan, Ben, Chirico, Paul
• Application Number:
  US11/468,759
• Publication Number:
  US 20070067034A1
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855

Abstract

An expandable stabilization device is disclosed that is suitable for deployment within cancellous bone, including, for example, within a vertebral body of a spine. The device comprises: an elongate expandable shaft adapted to be positioned within a vertebral body having a first profile and a second profile; wherein the shaft is adapted to cut through cancellous bone within the vertebral body during expansion from the first profile to the second profile; and further wherein the shaft is adapted to abut a surface of cortical bone within the vertebral body without passing therethrough. The invention also includes a method for treating cancellous bone, such as cancellous bone of a vertebral body. The method comprises: delivering an expandable device within the cancellous bone of in an interior of a vertebral body; expanding the delivered device within the cancellous bone of the vertebra body; applying force from a surface of the device to an inner surface of a cancellous bone of the vertebral body sufficient to cut through the cancellous bone; and applying force from a surface of the device to an inner surface of a cortical bone of the vertebral body sufficient to support the vertebral body

Claims

1. An expandable stabilization device for deployment within a vertebral body of a spine comprising:

(a) an elongate expandable shaft adapted to be positioned within the vertebral body having a first profile and a second profile;

(b) wherein the shaft is adapted to cut through cancellous bone within the vertebral body during expansion from the first profile to the second profile; and

(c) further wherein the shaft is adapted to abut a surface of cortical bone within the vertebral body without passing therethrough.

2. An expandable stabilization device for deployment within a cancellous bone comprising:

(a) an elongate expandable shaft adapted to be positioned within the cancellous bone having a first profile and a second profile;

(b) wherein the shaft is adapted to cut through cancellous bone during expansion from the first profile to the second profile; and

(c) further wherein the shaft is adapted to abut a surface of cortical bone adjacent the cancellous bone without passing therethrough.

3. The expandable stabilization device of claim 2 wherein the elongate shaft comprises a plurality of surface areas at least a portion of which is a cutting surface adapted to apply a cancellous bone cutting force to the cancellous bone of the vertebral body.

4. The expandable stabilization device of claim 2 wherein the elongate shaft comprises a plurality of cancellous bone cutting surfaces that deliver a force of from 2 psi to 100 psi to the cancellous bone.

5. The expandable stabilization device of claim 2 wherein the elongate shaft has an undeployed diameter of from 2 mm to 10 mm.

6. The expandable stabilization device of claim 2 wherein the elongate shaft has a deployed diameter of from 6 mm to 35 mm along at least a portion of its length.

7. The expandable stabilization device of claim 2 wherein the elongate shaft has a length of from 8 mm to 60 mm.

8. The expandable stabilization device of claim 2 wherein the elongate shaft has 2 or more elongate slits along its length.

9. The expandable stabilization device of claim 8 wherein the elongate slits have asymmetrically positioned notches along its length.

10. The expandable stabilization device of claim 8 wherein the elongate slits have symmetrically positioned notches along its length.

11. The expandable stabilization device of claim 2 wherein the slits are positioned symmetrically or asymmetrically along the length of the shaft.

12. The expandable stabilization device of claim 2 wherein the elongate shaft has a pair of open ended slits at an end of the shaft.

13. The expandable stabilization device of claim 2 wherein the elongate shaft is self-expanding.

14. The expandable stabilization device of claim 2 wherein the elongate shaft is controllably expandable.

15. The expandable stabilization device of claim 2 wherein the elongate shaft is adapted to support a compressive load when expanded.

16. The expandable stabilization device of claim 2 wherein the elongate shaft is adapted to expand to a profile sufficient to achieve a target vertebral body height.

17. The expandable stabilization device of claim 2 wherein the elongate shaft is adapted to expand more in a first dimension than in a second dimension.

18. The expandable stabilization device of claim 2 wherein the elongate shaft is adapted to expand equally in a first dimension and a second dimension.

19. The expandable stabilization device of claim 2 wherein the elongate shaft comprises a first section expandable to a first profile and a second section expandable to a second profile.

20. The expandable stabilization device of claim 2 wherein the device is mounted to a delivery device and adapted to establish a subcutaneous path into the vertebral body.

21. The expandable stabilization device of claim 2 further comprising a control member positioned within a lumen of the shaft configured to expand the shaft from the first profile to the second profile.

22. The expandable stabilization device of claim 2 wherein the device further comprises a lumen through which material is delivered into the vertebral body.

23. The expandable stabilization device of claim 2 wherein the device is formed from a material selected from the group consisting of metals, plastics, composites or memory materials.

24. The expandable stabilization device of claim 2 wherein the device is formed from a biologic or nonbiologic material that promotes fusion.

25. The expandable stabilization device of claim 2 wherein the surface is modified to prevent slippage.

26. The expandable stabilization device of claim 25 wherein the surface is selected from the group consisting of:

dimple, nub, knurl, and teeth.

27. The expandable stabilization device of claim 2 wherein the device is formed at least partially from shape memory material.

28. A system for cutting through cancellous bone within a vertebral body of a spine without cutting through cortical bone of the vertebral body comprising:

(a) an expandable body having a first profile and a second profile wherein a surface of the expandable body is adapted to cut through cancellous bone within the vertebral body; and

(b) a delivery device having a distal end adapted to engage the expandable body to deliver the delivery device into the vertebral body.

29. An expandable device adapted to apply force sufficient to cut through cancellous bone within a vertebral body of a spine and insufficient to cut through a cortical bone section of the vertebral body during expansion of the device wherein the device restores a height of a vertebral body to a target height.

30. A method for treating a bone comprising:

(a) delivering an expandable device within a cancellous bone;

(b) expanding the delivered device within the cancellous bone;

(c) applying force from a cutting surface of the device to the cancellous bone sufficient to cut through the cancellous bone; and

(d) applying force from a support surface of the device to an inner surface of a cortical bone sufficient to support the cortical bone.

31. The method of claim 30 further comprising the step of applying force from the surface of the device to the cortical bone of a vertebral body sufficient to increase a distance between two cortical bone surfaces.

32. The method of claim 30 further comprising the step of confirming a position of a vertebral body.

33. The method of claim 30 further comprising the step of administering a material within a space created in a portion of the cancellous bone to facilitate bone restoration.

34. The method of claim 30 further comprising the step of administering a material within a space created in a portion of the cancellous bone to stabilize a position of the device.

35. The method of claim 30 further comprising the step of applying force from the surface of the device to the cortical bone sufficient to increase a distance between a first section of the cortical bone and a second section of the cortical bone at a target location within the bone.

36. The method of claim 30 further comprising the step of applying force from the surface of the device to the cortical bone sufficient to increase a distance between a caudad cortical section of a vertebral body and a cephalad cortical section of a vertebral body.

37. The method of claim 30 further comprising the step of removing a deployed device.

38. The method of claim 37 further comprising the steps of accessing the deployed device;

engaging the deployed device with a tool;

reducing a profile of the device; and

withdrawing the device.

39. A cannula adapted to be deployed within a vertebral body of a spine comprising:

(a) an elongate expandable tube adapted to be positioned within a vertebral body having a first profile and a second profile;

(b) wherein the tube is adapted to cut through cancellous bone located within the vertebral body during expansion from the first profile to the second profile;

(c) further wherein the tube is adapted to deliver a target material through the elongate expandable tube into the vertebral body; and

(d) further wherein the tube is adapted to abut a cortical bone surface within the vertebral body without completely passing therethrough.

40. An expandable device for use in treating a fractured or collapsed vertebral body of a spine comprising:

(a) a device adapted to cut through cancellous bone interior the vertebral body and abut an inner surface of cortical bone of the vertebral body comprising an elongate expandable shaft adapted to be positioned with the vertebral body having a delivery profile and a deployed profile; and

(b) wherein the device selectively expands along its length in the deployed profile to selectively restore the height of a portion of the fractured or collapsed vertebral body to a target height.

41. A system for cutting through cancellous bone of a vertebral body of a spine comprising an expandable body having a selectively expandable surface adapted to expand in situ in an angled direction non-parallel to a median sagittal plane of a body and non-parallel to a transverse plane of a body.

42. A stabilization device for deployment within a vertebral body of a spine comprising:

(a) an elongate expandable shaft having a first profile and a second profile;

(b) a cutting surface on at least a portion of the expandable shaft;

(c) wherein the cutting surface cuts through cancellous bone; and

(d) further wherein the cutting surface abuts a surface of cortical bone within the vertebral body without passing therethrough.