Formed in place fixation system with thermal acceleration

• US 20020198526A1
• Filed: 05/31/2002
• Published: 12/26/2002
• Est. Priority Date: 06/23/2000
• Status: Active Grant

• 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, James Huntington
• Granted Patent: US 6,964,667 B2
• Time in Patent Office: Days
• US Class Current: 606/254
• 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 in situ formable orthopedic fixation rod, comprising:

an elongate, tubular balloon, having an interior chamber therein, and inflatable from a first, insertion profile to a second, enlarged profile; and

an accelerator, for accelerating the curing of a curable media following introduction of the media into the chamber.

2. An in situ formable orthopedic fixation rod as in claim 1, wherein the accelerator comprises a heat source.

3. An in situ formable orthopedic fixation rod as in claim 2, wherein the heat source comprises a resistive heating element.

4. An in situ formable orthopedic fixation rod as in claim 3, wherein the resistive heating element comprises a conductive coil.

5. An in situ formable orthopedic fixation rod as in claim 3, wherein the resistive heating element comprises a plurality of carbon fibers.

6. An in situ formable orthopedic fixation rod as in claim 2, further comprising a heat sensor carried by the balloon.

7. An in situ formable orthopedic fixation rod as in claim 2, wherein the heat source is capable of heating the media to at least about 50 degrees C.

8. An in situ formable orthopedic fixation rod as in claim 7, wherein the heat source is capable of heating the media to at least about 60 degrees C.

9. An in situ formable orthopedic fixation rod as in claim 1, wherein the balloon comprises a substantially inelastic material.

10. An in situ formable orthopedic fixation rod as in claim 1, wherein the balloon comprises a compliant material.

11. An in situ formable orthopedic fixation rod as in claim 1, wherein the reinforcement element comprises an expandable tubular stent.

12. An in situ formable orthopedic fixation rod as in claim 1, wherein the balloon has an inflated length of at least about 5 cm.

13. An in situ formable orthopedic fixation rod as in claim 1, in combination with a first and a second bone anchors.

15. The device of claim 14, further comprising a hardenable media for inflating said inflatable member.

16. The device of claim 15, wherein said hardenable media comprises a rapid setting, liquid polymer.

17. The device of claim 16, wherein said polymer is a light activated polymer.

18. The device of claim 14, wherein said central lumen comprises an inflation lumen.

19. The device of claim 14, wherein said central lumen comprises a stiffening wire lumen.

20. The device of claim 14, 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.

21. The device of claim 20, wherein said annular lumen comprises an inflation lumen.

22. The device of claim 14, wherein said inflatable member comprises a balloon.

23. The device of claim 14, wherein the heat source comprises a resistive heating element.

24. The device of claim 14, wherein the heat source comprises a circulating loop for circulating a heated media.

25. The device of claim 14, wherein the heat source comprises an RF antenna.

26. The device of claim 14, wherein the heat source comprises an ultrasound transducer.

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

28. The device of claim 14, wherein the heat source comprises a waveguide.

14. 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.

29. A method of stabilizing an orthopedic fracture, comprising:

inserting at least two anchors having portals into a bone;

delivering an orthopedic device comprising an inflatable balloon to the bone;

inflating said balloon with a stiffening material; and

heating the media above body temperature to accelerate stiffening of the stiffening material;

wherein said orthopedic device extends through said portals, such that said inflating fixes said anchors in relation to one another.

30. A formed in place orthopedic device, comprising:

an outer wall, defining a cavity therein;

a plurality of reinforcing fibers in the cavity;

a hardenable media for bonding with the reinforcing fibers to form the orthopedic device; and

a heating element for heating the hardenable media;

wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place orthopedic device.

31. A formed in place orthopedic device as in claim 30, wherein the hardenable media comprises an epoxy.

32. A formed in place orthopedic device as in claim 30, wherein the hardenable media comprises polyurethane.

33. A formed in place orthopedic device as in claim 30, wherein the reinforcing fibers comprise carbon fibers.

34. A formed in place orthopedic device as in claim 30, wherein the reinforcing fibers comprise graphite fibers having a diameter within the range of from about 0.003 inches to about 0.007 inches.

35. A formed in place orthopedic device as in claim 30, wherein the reinforcing fibers are provided in at least one bundle having within the range of from about 3,000 to about 12,000 fibers.

36. A formed in place orthopedic device as in claim 35, comprising from about 30 to about 60 bundles of fibers.

37. A formed in place orthopedic device as in claim 30, wherein the reinforcing fibers have a Tow tensile strength within the range of from about 5,000 Mpa to about 7,000 Mpa.

38. A formed in place orthopedic device as in claim 30, wherein the reinforcing fibers have a Tow tensile modulus within the range of from about 250 Gpa to about 350 Gpa.

39. A formed in place orthopedic device as in claim 30, further comprising at least one reinforcing sleeve within the cavity.

40. A formed in place orthopedic device as in claim 30, wherein the reinforcing sleeve comprises a braided carbon fiber wall.

41. A method of forming an orthopedic device at a treatment site within the body of a patient, comprising the steps of:

positioning an outer wall at the treatment site within the patient, the outer wall defining a chamber therein;

introducing a hardenable media into the chamber; and

heating the hardenable media to accelerate hardening, to form the orthopedic device.

42. A method of forming an orthopedic device as in claim 41, wherein the positioning step comprises positioning the outer wall between two bone anchors.

43. A method of treating a patient, comprising the steps of:

securing a first rod at a first site in the patient;

securing a second rod at a second site in the patient;

introducing a curable media in between the first and second rods to form a cross link; and

heating at least a portion of the media to a temperature of at least about 50 degrees C., to accelerate curing of the media thereby linking the first rod to the second rod.

44. A method of treating a patient as in claim 43, wherein the introducing step comprises introducing the curable media into a tubular media support structure extending between the first and second rods.

45. A method of treating a patient as in claim 44, wherein the support structure comprises a balloon.

46. A method of treating a patient as in claim 43, wherein the method is accomplished percutaneously.

47. A method as in claim 43, wherein the linking step comprises positioning a balloon between the first and second rods and introducing the media into the balloon.

49. An implantable device as in claim 48, wherein the flexible wall is the wall of a balloon.

50. An implantable device as in claim 48, wherein the device has an inflated length of at least about 3 cm.

51. An implantable device as in claim 48, wherein the device has an inflated length of at least about 5 cm.

52. An implantable device as in claim 48, wherein the device has an inflated diameter of no more than about 2 cm.

53. An implantable device as in claim 48, wherein the device has an inflated diameter of no more than about 1 cm.

54. An implantable device as in claim 48, further comprising a reinforcing element within the cavity.

48. An implantable formed in place medical device, comprising:

a flexible wall, defining an interior cavity;

a heating element in thermal communication with the cavity;

an inflation pathway in flow communication with the cavity; and

a stop, for closing the pathway.

55. A deployment catheter, for deploying an implantable inflatable orthopedic device, comprising:

an elongate, flexible tubular body, having a proximal end and a distal end;

an inflatable device removably carried by the distal end;

an energy source connected to the proximal end; and

a heating element in thermal communication with the inflatable device.

56. A deployment catheter as in claim 55, wherein the inflatable device comprises a balloon.

57. A deployment catheter as in claim 55, wherein the tubular body comprises a first tube having a proximal end and a distal end, and a second tube movably positioned within the first tube.

58. A deployment catheter as in claim 57, wherein the inflatable device is removably carried by the distal end of the first tube.

59. A deployment catheter as in claim 58, wherein the second tube extends into the inflatable device.

60. A deployment catheter as in claim 57, wherein the inflatable device is removably carried by the second tube.

61. An inflatable orthopedic fixation rod, comprising:

an elongate, tubular balloon, having an interior chamber therein, and inflatable from a first, insertion profile to a second, enlarged profile; and

a resistance heating element within the chamber.

62. An inflatable orthopedic fixation rod as in claim 61, wherein the heating element has a resistance of at least about 30 ohms.

63. An inflatable orthopedic fixation rod as in claim 61, wherein the heating element achieves a temperature of at least about 50°

C. upon application of a voltage of no more than about 12 V.

64. An inflatable orthopedic fixation rod as in claim 61, wherein the heating element comprises Tungsten.

65. An inflatable orthopedic fixation rod as in claim 61, in combination with a first and a second bone anchors.

66. A bone fixation device, comprising:

a delivery catheter;

comprising an inflatable member;

a heat source carried by the inflatable member; and

at least two anchors having portals,

wherein said inflatable member extends through said portals of said at least two anchors.

67. A method of stabilizing an orthopedic fracture, comprising:

inserting at least two anchors having portals into a bone;

delivering an orthopedic device comprising an inflatable balloon through the portals;

inflating said balloon with a hardenable material; and

elevating the temperature of at least a portion of the hardenable material to above about 45°

C.;

wherein the inflating step fixes said anchors in relation to one another.