Apparatus and methods for use of expandable members in surgical applications

• US 8,926,620 B2
• Filed: 09/28/2011
• Issued: 01/06/2015
• Est. Priority Date: 08/25/2006
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Chasmawala, Nishith, Auyoung, Bryan J., Hsia, Alex Y., Jansen, Lex P., Phan, Christopher U., Gong, Gorman D.
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US13/247,879
• Publication Number:
  US 20120022540A1
• Time in Patent Office: 1,196 Days
• Field of Search: 606/90, 606/105, 606/159, 606/191, 606/192, 606/194, 606/198, 600/203, 600/207, 604/96.01, 604/102.01, 604/103, 604/103.05, 604/103.06, 604/103.07, 604/103.14, 604/108, 604/165, 623/1.11
• US Class Current: 606/90
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

In some embodiments, an apparatus includes an elongated member, an expandable member coupled to the elongated member, and an outer sheath. The outer sheath, which can be constructed from a different material than the expandable member, is disposed about the expandable member such that an outer surface of the expandable member is in discontinuous contact with an inner surface of the outer sheath. The expandable member and the outer sheath are configured to cooperatively displace a bone structure when moving between a collapsed configuration and an expanded configuration.

Claims

1. A method, comprising:

coupling, to an elongated member defining a longitudinal axis, an expandable member configured to displace a first portion of a spine relative to a second portion of the spine when moving between a collapsed configuration and an expanded configuration;

disposing an outer sheath about the expandable member such that the outer sheath covers a distal end portion of the elongated member extending transverse to the longitudinal axis; and

placing a clamp about a portion of the outer sheath to couple the outer sheath to the expandable member.

2. The method of claim 1, wherein:

the first portion of the spine is a first portion of a vertebral body; and

the second portion of the spine is a second portion of the vertebral body.

3. The method of claim 1, further comprising forming the expandable member.

4. The method of claim 1, further comprising forming the expandable member using at least one of an extrusion process or a blow molding process.

5. The method of claim 1, wherein the coupling includes forming a fluid-tight seal between the expandable member and the elongated member.

6. The method of claim 1, wherein the placing includes adjusting a length of the clamp by at least one of stretching the clamp, crimping the clamp, heat shrinking the clamp or mechanically tightening the clamp.

7. The method of claim 1, further comprising defining a plurality of pleats in the expandable member before the disposing the outer sheath about the expandable member.

8. The method of claim 1, further comprising wrapping the expandable member about the elongated member before the disposing.

9. The method of claim 1, further comprising defining a plurality of pleats in the expandable member after the disposing the outer sheath about the expandable member.

10. The method of claim 1, wherein an inner surface of the expandable member engages an outer surface of the elongated member and the method further comprises coupling the expandable member to an outer shaft such that the elongated member extends though the outer shaft and the inner surface of the expandable member engages an outer surface of the outer shaft.

11. The method of claim 1, wherein the inner surface of the first layer engages an outer surface of the elongated member and the method further comprises coupling the expandable member to an outer shaft such that the elongated member extends though the outer shaft and the inner surface of first layer engages an outer surface of the outer shaft.

12. A method, comprising:

inserting an expandable member into an interior portion of a bone structure, the expandable member including a first layer and a second layer disposed about the first layer such that an outer surface of the first layer is in discontinuous contact with an inner surface of the second layer, the first layer constructed from a first polymer having a molecular structure, the second layer constructed from a second polymer having a molecular structure more amorphous than the molecular structure of the first polymer, the expandable member being coupled to an elongated member defining a longitudinal axis such that the second layer covers a distal end portion of the elongated member that extends transverse to the longitudinal axis; and

expanding the expandable member while the expandable member is disposed within the interior portion of the bone structure such that the expandable member exerts a force sufficient to cause a first portion of the bone structure to move relative to a second portion of the bone structure.

13. The method of claim 12, wherein at least one of the first portion of the bone structure or the second portion of the bone structure includes recalcitrant bone.

14. The method of claim 12, wherein the inserting includes inserting the expandable member via a cannula.

15. The method of claim 12, wherein the expanding includes displacing the first portion of the bone structure relative to the second portion of the bone structure.

16. The method of claim 12, wherein the expanding includes withstanding puncture of the expandable member from a portion of the bone structure.

17. The method of claim 12, wherein the expanding includes inflating the expandable member to a pressure of at least 1.4 Megapascals.

18. The method of claim 12, wherein the expanding includes inflating the expandable member to a pressure of at least 2.8 Megapascals.

19. The method of claim 12, wherein the expanding includes inflating the expandable member to a pressure of at least 5.5 Megapascals.

20. The method of claim 12, wherein the expanding includes moving the first layer of the expandable member relative to the second layer of the expandable member.