Formed in place fixation system with thermal acceleration

• US 6,964,667 B2
• Filed: 05/31/2002
• Issued: 11/15/2005
• Est. Priority Date: 06/23/2000
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Shaolian, Samuel M., Nguyen, Thanh Van, Pham, To V., Teitelbaum, George P., Dabney, Hunt
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US10/161,554
• Publication Number:
  US 20020198526A1
• Time in Patent Office: 1,264 Days
• Field of Search: 606/60, 606/62, 606/63, 606/68, 606/86, 606/90, 606/99, 606/192, 606/195, 606/198, 606/61, 606/72, 623/17.12, 604/96.01
• US Class Current: 606/99
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7008 with parts of, or attached to, the longitudinal elements, bearing against an outside of the screw or hook heads, e.g. nuts on threaded rods A61B17/7007 takes precedence
• CPC Class Codes: A61B 17/7049 Connectors, not bearing on the vertebrae, for linking longitudinal elements together A61B17/7055, A61B17/7053, A61B17/7019 take precedence
• 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 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: Y10S 606/91 Polymer

Abstract

A subcutaneously formed in place orthopedic fixation device is provided, such as for fixation of the spine or other bone or bones. The device comprises an inflatable member, such as a tubular balloon. A heat source is provided in thermal communication with the interior of the balloon. The balloon is positioned at a treatment site while in a flexible, low crossing profile configuration. The balloon is thereafter inflated with a hardenable media, and heated to accelerate hardening of the media. Methods and delivery structures are also disclosed.

Claims

1. An orthopedic fixation device, comprising:

an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen;

a manifold at the proximal end of the tubular body comprising at least one port;

an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body;

a heat source in thermal communication with the interior of the inflatable member; and

a valve, provided at the proximal end of the inflatable member;

wherein the inflatable member has a predetermined inflated profile with an inflated length and an inflated diameter, the ratio of the inflated length to the inflated diameter being at least about 4;

1.

2. The device of claim 1, further comprising a hardenable media for inflating said inflatable member.

3. The device of claim 2, wherein said hardenable media comprises a rapid setting, liquid polymer.

4. The device of claim 3, wherein said polymer is a light activated polymer.

5. The device of claim 1, wherein said central lumen comprises an inflation lumen.

6. The device of claim 1, wherein said central lumen comprises a stiffening wire lumen.

7. The device of claim 1, wherein said elongate tubular body comprises an inner sleeve and an outer sleeve, forming an annular lumen between said inner sleeve and said outer sleeve.

8. The device of claim 7, wherein said annular lumen comprises an inflation lumen.

9. The device of claim 1, wherein said inflatable member comprises a balloon.

10. The device of claim 1, wherein the heat source comprises a resistive heating element.

11. The device of claim 1, wherein the heat source comprises a circulating loop for circulating a heated media.

12. The device of claim 1, wherein the heat source comprises an RF antenna.

13. The device of claim 1, wherein the heat source comprises an ultrasound transducer.

14. The device of claim 1, wherein the heat source comprises a microwave antenna.

15. The device of claim 1, wherein the heat source comprises a waveguide.

16. The device as in claim 1, wherein the ratio of the inflated length to the inflated diameter is at least about 6:

1.

17. The device as in claim 1, wherein the inflated diameter is within a range of about 5 cm to about 2 cm.

18. The device as in claim 1, wherein the inflated length is within a range of about 2 cm to about 12 cm.

19. The device as in claim 1, wherein the inflated length is within a range of about 10 cm to about 20 cm.

20. An orthopedic fixation device, comprising:

an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen;

a manifold at the proximal end of the tubular body comprising at least one port;

an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body;

a heat source in thermal communication with the interior of the inflatable member;

a valve, provided at the proximal end of the inflatable member;

a hardenable media for inflating the inflatable member;

wherein, when the hardenable media is hardened, the inflatable member and the hardenable media form a fixation rod that exhibits a static compression bending value that is greater than about 100 lbs.

21. The device of claim 20, wherein the fixation rod exhibits a static compression bending value that is greater than about 150 lbs.

22. The device of claim 20, wherein said polymer is a light activated polymer.

23. The device of claim 20, wherein said central lumen comprises an inflation lumen.

24. The device of claim 20, wherein said central lumen comprises a stiffening wire lumen.

25. The device of claim 20, wherein said elongate tubular body comprises an sleeve and an outer sleeve, forming an annular lumen between said inner sleeve and said outer sleeve.

26. The device of claim 25, wherein said annular lumen comprises an inflation lumen.

27. The device of claim 20, wherein said inflatable member comprises a balloon.

28. The device of claim 20, wherein the heat source comprises a resistive heating element.

29. The device of claim 20, wherein the heat source comprises a circulating loop for circulating a heated media.

30. The device of claim 20, wherein the heat source comprises an RF antenna.

31. The device of claim 20, wherein the heat source comprises an ultrasound transducer.

32. The device of claim 20, wherein the heat source comprises a microwave antenna.

33. The device of claim 20, wherein the heat source comprises a waveguide.

34. The device of claim 20, wherein the inflatable member has a predetermined inflated profile having an inflated length and an inflated diameter, the ratio of the inflated length to the inflating diameter being at lea t bout 4:

1.

35. The device as in claim 34, wherein the ratio of the inflated length to the inflated diameter is at least about 6:

1.

36. The device as in claim 34, wherein the inflated diameter is within a range of about 0.5 cm to about 2 cm.

37. The device as in claim 34, wherein the inflated length is within a range of about 2 cm to about 12 cm.

38. The device as in claim 34, wherein the inflated length is within a range of about 10 cm to about 20 cm.