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

• US 20090234398A1
• Filed: 05/27/2009
• Published: 09/17/2009
• Est. Priority Date: 08/31/2005
• Status: Abandoned Application

• Current Assignee: SpineAlign Medical, Inc.
• Original Assignee: SpineAlign Medical, Inc.
• Inventors: Chan, Ben M., Chirico, Paul E.
• Application Number:
  US12/473,175
• Publication Number:
  US 20090234398A1
• Time in Patent Office: Days
• US Class Current: 606/86.R
• 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. A method for treating bone by implanting a self-expanding stabilization device, the method comprising:

holding a self-expanding stabilization device in a collapsed delivery configuration, wherein the stabilization device comprises an elongate tubular body having a plurality of expandable struts further wherein the stabilization device is held in the collapsed configuration by a delivery device coupled to the stabilization device;

inserting the collapsed stabilization device into a bone;

allowing the stabilization device to self-expand into an expanded deployed configuration so that the struts cut through the bone as they expand;

removing the delivery device from the stabilization device; and

securing the stabilization device within the bone by applying material in and around the stabilization device.

2. The method of claim 1 further comprising forming an access hole into a region of cancellous bone into which the collapsed implant is inserted.

3. The method of claim 1, wherein the step of holding the self-expanding stabilization device in the collapsed delivery configuration comprises engaging the stabilization device with the delivery device and contracting the stabilization device to reduce the profile of the stabilization device to the non-deployed configuration.

4. The method of claim 1, wherein the step of inserting the collapsed stabilization device into bone comprises inserting the stabilization device into cancellous bone.

5. The method of claim 1 further comprising the step of applying force from the stabilization device to cortical bone to restore height of the cortical bone.

6. The method of claim 1, wherein the step of allowing the stabilization device to expand comprises controlling the self-expansion of the stabilization device.

7. The method of claim 6, wherein the self-expansion of the stabilization device is controlled by a ratcheting mechanism of the delivery device.

8. The method of claim 1, wherein the step of allowing the stabilization device to expand comprises applying a force of between about 2 psi and 100 psi to the bone from the expanding struts to cut through the bone.

9. The method of claim 1, wherein the step of securing the stabilization device within the bone comprises applying material through a central lumen of the stabilization device.

10. The method of claim 1, wherein the step of securing the stabilization device within the bone by applying material in and around the stabilization device comprises applying at least one of the materials selected from the group consisting of:

cement, bone filer and allograft material.

11. A method for treating bone by implanting a self-expanding stabilization device, the method comprising:

holding a self-expanding stabilization device in a collapsed configuration, wherein the stabilization device comprises an elongate body having a plurality of expandable struts and wherein the stabilization device is coupled to a delivery device so that a control rod passes through a central lumen of the stabilization device and couples to the stabilization device near the distal end of the stabilization device;

inserting the collapsed stabilization device into a bone;

allowing the plurality of struts of the self-expanding stabilization device to expand and cut through bone; and

securing the expanded stabilization device within the bone by applying cement in and around the stabilization device.

12. The method of claim 11 further comprising forming an access hole into a region of cancellous bone into which the collapsed implant is inserted.

13. The method of claim 11, wherein the step of holding the self-expanding stabilization device in the collapsed configuration comprises engaging the distal end of the stabilization device with the delivery device while the control rod is extended distally.

14. The method of claim 11, wherein the step of inserting the collapsed stabilization device into bone comprises inserting the stabilization device into cancellous bone.

15. The method of claim 11 further comprising the step of applying force from the stabilization device to cortical bone to restore height of the cortical bone.

16. The method of claim 11, wherein the step of allowing the plurality of struts to expand comprises controlling the self-expansion of the struts.

17. The method of claim 16, wherein the self-expansion of the plurality of struts is controlled by a ratcheting mechanism of the delivery device.

18. The method of claim 11, wherein the step of allowing the plurality of struts to expand comprises applying a force of between about 2 psi and 100 psi to the bone from the expanding struts to cut through the bone.

19. The method of claim 11, wherein the step of securing the expanded stabilization device within the bone comprises applying cement through a central lumen of the stabilization device.

20. A method for treating bone by implanting a self-expanding stabilization device, the method comprising:

holding a stabilization device in delivery configuration by preventing a plurality of self-expanding struts of the stabilization device from expanding;

inserting the stabilization device into a cancellous bone;

allowing the struts of the stabilization device to self-expand and cut through the cancellous bone; and

stabilizing the stabilization device within the bone by administering a material through the stabilization device to fill the region in and around the stabilization device.