Formable orthopedic fixation system

• US 20020082600A1
• Filed: 08/29/2001
• Published: 06/27/2002
• Est. Priority Date: 06/23/2000
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Shaolian, Samuel M., Nguyen, Thanh Van, Pham, To V., Teitelbaum, George P.
• Granted Patent: US 6,899,713 B2
• Time in Patent Office: Days
• US Class Current: 606/61
• 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 17/7002 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 17/7013 the shape of the element being adjustable before use adjustable length plates A61B17/7014
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/4611 of spinal prostheses

Abstract

An implantable inflatable orthopedic device is provided. The device comprises a flexible wall, defining an interior cavity, a reinforcing element exposed to the cavity, an inflation pathway in communication with the cavity, and a valve, for closing the pathway. A delivery catheter is also provided for removably carrying the orthopedic device to the treatment site.

Claims

1. An implantable inflatable orthopedic device, comprising:

a flexible wall, defining an interior cavity;

a reinforcing element exposed to the cavity;

an inflation pathway in communication with the cavity; and

a valve, for closing the pathway.

2. An implantable orthopedic device as in claim 1, wherein the flexible wall is the wall of a balloon.

3. An implantable orthopedic device as in claim 2, wherein the reinforcing element is carried within the balloon.

4. An implantable orthopedic device as in claim 1, wherein the device has an inflated length of at least about 3 cm.

5. An implantable orthopedic device as in claim 1, wherein the device has an inflated length of at least about 5 cm.

6. An implantable orthopedic device as in claim 4, wherein the device has an inflated diameter of no more than about 2 cm.

7. An implantable orthopedic device as in claim 4, wherein the device has an inflated diameter of no more than about 1 cm.

8. An implantable orthopedic device as in claim 1, wherein the reinforcing element comprises metal.

9. An implantable orthopedic device as in claim 1, wherein the reinforcing element comprises an expandable tube.

10. An implantable orthopedic device as in claim 9, wherein the tube comprises a slotted metal tube.

11. An implantable orthopedic device as in claim 9, wherein the tube comprises wire.

12. An implantable orthopedic device as in claim 1, wherein the reinforcing element comprises at least one reinforcing wire.

13. An implantable orthopedic device as in claim 1, further comprising a hardenable media within the cavity.

14. An implantable orthopedic device as in claim 13, wherein the hardenable media comprises a bone cement.

15. An implantable orthopedic device as in claim 13, wherein the hardenable media comprises polymethyl methacrylate.

16. An implantable orthopedic device as in claim 13, wherein the reinforcing element is embedded within the hardenable media.

17. An implantable orthopedic device as in claim 13, further comprising at least a first bone anchor attached to the orthopedic device.

18. An implantable orthopedic device as in claim 17, wherein the first bone anchor includes a first aperture, and the orthopedic device extends through the first aperture.

19. An implantable orthopedic device as in claim 17, comprising a second bone anchor having a second aperture, and the orthopedic device extends through the second aperture.

20. An implantable orthopedic device as in claim 18, comprising a second bone anchor having a second aperture, and the orthopedic device extends through the second aperture.

21. An implantable orthopedic device as in claim 20, wherein the first bone anchor is implanted within a first bone.

22. An implantable orthopedic device as in claim 21, wherein the second bone anchor is implanted within a second bone.

23. An implantable orthopedic device as in claim 22, wherein the first and second bones are in the spine.

24. An implantable orthopedic device as in claim 23, wherein the first and second bones are adjacent vertebrae.

26. A deployment catheter as in claim 25, wherein the inflatable device comprises a balloon.

27. A deployment catheter as in claim 26, wherein the reinforcing element comprises an expandable tube positioned within the balloon.

28. A deployment catheter as in claim 25, 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.

29. A deployment catheter as in claim 28, wherein the inflatable device is removably carried by the distal end of the first tube.

30. A deployment catheter as in claim 29, wherein the second tube extends into the inflatable device.

31. A deployment catheter as in claim 28, wherein the inflatable device is removably carried by the second tube.

25. 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; and

a reinforcing element within the inflatable device.

32. 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 reinforcement element within the chamber.

33. An inflatable orthopedic fixation rod as in claim 32, wherein the balloon comprises a substantially inelastic material.

34. An inflatable orthopedic fixation rod as in claim 32, wherein the balloon comprises a compliant material.

35. An inflatable orthopedic fixation rod as in claim 32, wherein the reinforcement element comprises an expandable tubular stent.

36. An inflatable orthopedic fixation rod as in claim 32, wherein the balloon has an inflated length of at least about 5 cm.

37. An inflatable orthopedic fixation rod as in claim 32, in combination with a first and a second bone anchors.

39. The device of claim 38, further comprising a hardenable media for inflating said inflatable member.

40. The device of claim 39, wherein said hardenable media comprises polymethyl methacrylate.

41. The device of claim 39, wherein said hardenable media comprises a rapid setting, liquid polymer.

42. The device of claim 41, wherein said polymer is a light activated polymer.

43. The device of claim 38, wherein said central lumen comprises an inflation lumen.

44. The device of claim 38, wherein said central lumen comprises a stiffening wire lumen.

45. The device of claim 38, wherein said elongate shaft comprises an inner sleeve and an outer sleeve, forming an annular lumen between said inner sleeve and said outer sleeve.

46. The device of claim 45, wherein said annular lumen comprises an inflation lumen.

47. The device of claim 38, wherein said inflatable member comprises a balloon.

48. The device of claim 47, wherein said balloon comprises reinforcing wires.

49. The device of claim 47, wherein said balloon comprises struts.

50. The device of claim 38, wherein said valve is self-sealing.

51. The device of claim 38, further comprising a radiopaque marker.

52. The device of claim 38, further comprising a stiffening wire.

38. An orthopedic fixation device, comprising:

a hollow elongate shaft having a distal end and a proximal end, said hollow shaft forming a central lumen;

a manifold at the proximal end of said shaft comprising at least one port;

an inflatable member having a proximal end and a distal end, removably attached to the distal end of said shaft; and

a valve, provided at the proximal end of said inflatable member.

53. A bone fixation device, comprising:

a delivery catheter;

comprising an inflatable member; and

at least two anchors having portals,

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

54. 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;

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

55. A formed in place orthopedic device, comprising:

an outer wall, defining a cavity therein;

a plurality of reinforcing fibers in the cavity; and

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

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.

56. A formed in place orthopedic device as in claim 55, wherein the hardenable media comprises an epoxy.

57. A formed in place orthopedic device as in claim 55, wherein the hardenable media comprises polyurethane.

58. A formed in place orthopedic device as in claim 55, wherein the reinforcing fibers comprise carbon fibers.

59. A formed in place orthopedic device as in claim 55, wherein the reinforcing fibers comprise graphite fibers having a diameter within the range of from about 0.003 inches to about 0.007 inches.

60. A formed in place orthopedic device as in claim 55, 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.

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

62. A formed in place orthopedic device as in claim 55, wherein the reinforcing fibers have a Tow tensile strength within the range of from about 5,000 Mpa to about 7,000 Mpa.

63. A formed in place orthopedic device as in claim 55, wherein the reinforcing fibers have a Tow tensile modulus within the range of from about 250 Gpa to about 350 Gpa.

64. A formed in place orthopedic device as in claim 55, further comprising at least one reinforcing sleeve within the cavity.

65. A formed in place orthopedic device as in claim 55, wherein the reinforcing sleeve comprises a braided carbon fiber wall.

66. 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 which contains a plurality of reinforcing fibers;

introducing a hardenable media into the chamber to harden with the fibers to form the orthopedic device.

67. A method of forming an orthopedic device as in claim 66, wherein the positioning step comprises positioning the outer wall between two bone anchors.