Methods and apparatus for treating vertebral fractures

• US 8,734,458 B2
• Filed: 12/07/2009
• Issued: 05/27/2014
• Est. Priority Date: 12/07/2009
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Globus Medical, Inc.
• Inventors: O'Halloran, Damien, Paul, David C., Suh, Sean
• Primary Examiner(s): Yang, Andrew
• Assistant Examiner(s): Chang, Olivia C
• Application Number:
  US12/632,325
• Publication Number:
  US 20110137317A1
• Time in Patent Office: 1,632 Days
• Field of Search: 606 92- 95, 606/105
• US Class Current: 606/92
• CPC Class Codes: A61B 17/7094 Solid vertebral fillers; devices for inserting such fillers
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8802 Equipment for handling bone cement or other fluid fillers
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment

Abstract

Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment. Methods for treating a bone comprising: creating a cavity in the bone; inflating a containment jacket in the cavity; inflating a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket; introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon; removing the balloon from the containment jacket; and introducing a second filler material into the first portion of the containment jacket.

Claims

1. An inflation and containment device comprising:

a first balloon for creating a cavity within bone;

an exterior tube having a longitudinal axis and comprising an exterior passageway and an interior passageway extending along the longitudinal axis,

an interior fill tube extending through the interior passageway of the exterior tube;

a second balloon on a distal end of the interior fill tube;

a containment jacket on a distal end of the exterior tube, wherein the containment jacket encloses the second balloon;

wherein the inferior fill tube further comprises a cement filling tube for delivering a filler material into the containment jacket,

wherein the filler material within the containment jacket interdigitates with cancellous bon;

wherein the first balloon and the second balloon are inflated simultaneously.

3. The method of claim 1, wherein the bone is a vertebral body.

4. The method of claim 1, wherein creating the cavity comprises inflating another balloon in the bone.

5. The method of claim 1, wherein the containment jacket prevents leakage of the filler material.

6. The method of claim 1, wherein the containment jacket is at least partially coated with a bone growing agent.

7. The method of claim 1, wherein, after inflating the balloon, the balloon within the containment jacket provides pressure on walls of the cavity to prevent loss of height.

8. The method of claim 1, wherein inflating the balloon within the containment jacket increases height of the cavity.

9. The method of claim 1, wherein the first filler material occupies about 25% to about 75% by volume of the cavity.

10. The method of claim 1, wherein the first filler material and the second filler material both comprise the same material.

11. The method of claim 1, wherein the first filler material and the second filler material both comprise a bone cement.

12. The method of claim 1, wherein the first filler material and the second filler material substantially fill the cavity.

13. The method of claim 1, further comprising coating a bone growing agent on walls of the cavity.

14. The method of claim 1, further comprising introducing a device into the bone, wherein the device comprises:

an exterior tube having a longitudinal axis and comprising an exterior passageway and an interior passageway extending along the longitudinal axis;

the containment jacket on a distal end of the exterior tube and in a deflated state;

an interior fill tube extending through the interior passageway of the exterior tube; and

the balloon on a distal end of the interior fill tube and in a deflated state.

15. The method of claim 14, wherein the first filler material is introduced through the exterior passageway of the exterior tube.

16. The method of claim 15, wherein the second filler material is introduced through the interior passageway of the exterior tube.

2. A method for treating a bone comprising:

inserting a cavity creation balloon in the bone;

inserting an inflation and containment device, wherein the device comprises;

a containment jacket in the cavity;

a fill tube comprising a distal end having a tip; and

a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket, wherein the balloon extends from the tip of the fill tube;

inflating the cavity creation balloon and the balloon within the containment jacket simultaneously;

removing the cavity creation balloon;

introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon;

removing the balloon from the containment jacket; and

introducing a second filler material into the first portion of the containment jacket, wherein the second filler material is introduced via the fill tub;

wherein the filler material within the containment jacket interdigitates with cancellous bone.

17. A method for treating a vertebral fracture comprising:

introducing an inflation device into a vertebral body, wherein the inflation device comprises a fill tube and a balloon on a distal end of the fill tube;

inflating the balloon in the vertebral body to create a cavity within cancellous bone of the vertebral body;

removing the inflation device from the vertebral body;

introducing an inflation and containment device into the vertebral body, wherein the inflation and containment device comprises;

an exterior tube having a longitudinal axis and comprising an exterior passageway and an interior passageway extending along the longitudinal axis, wherein the exterior passageway surrounds the interior passageway and is separated from the interior passageway by an interior wall, and wherein the exterior tube has at least one exit port in a distal end for the exterior passageway,

an interior fill tube extending through the interior passageway of the exterior tube;

a second balloon on a distal end of the interior fill tube and in a deflated state;

a containment jacket on the distal end of the exterior tube and in a deflated state,

wherein the containment jacket encloses the second balloon;

inserting the containment jacket to at least partially fill the cavity;

inflating the second balloon such that the second balloon occupies a first portion of the containment jacket and applies pressure on walls of the cavity to maintain vertebral height;

introducing a filler material into a second portion of the containment jacket, wherein the second portion of the containment is not occupied by the second balloon;

allowing the filler material to cure in the second portion of the containment jacket, wherein the cured filler material applies pressure on the walls of the cavity to maintain vertebral height;

deflating the second balloon;

removing the second balloon from the containment jacket;

introducing the filler material into the first portion of the containment jacket via the inferior tube and allowing the material to cure,

wherein the filler material within the containment jacket interdigitates with cancellous bone

wherein the inflation balloon and the balloon within the containment jacket are inflated simultaneously.

18. The method of claim 17, wherein inflating the balloon increases height of the cavity.

19. The method of claim 18, wherein the filler material comprises bone cement.

20. The method of claim 18, further comprising coating a bone growing agent on walls of the cavity.