Systems and methods for inserting biocompatible filler materials in interior body regions

• US 20070055276A1
• Filed: 07/11/2006
• Published: 03/08/2007
• Est. Priority Date: 07/11/2005
• Status: Abandoned Application

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Edidin, Avram
• Application Number:
  US11/485,243
• Publication Number:
  US 20070055276A1
• Time in Patent Office: Days
• US Class Current: 606/92
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00362 Packages or dispensers for MIS instruments A61B2017/0479 takes precedence
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity

Abstract

Systems and methods for inserting biocompatible filler materials in interior body regions are described. In one described method, an expansible body comprising a body material substantially resistant to at least one of a biocompatible filler material and a chemical component of the biocompatible filler material may be inserted into a treatment area along a path established by a hollow member. The expansible body may then be expanded within the treatment area. The biocompatible filler material may be inserted into the treatment area while the expansible body is expanded therein.

Claims

1. A system comprising:

an elongate member comprising a distal end; and

an expansible body comprising a body material, the expansible body disposed at the distal end of the elongate member and configured to be maneuverable along a path established by a hollow member;

a sheath surrounding at least a portion of the expansible body configured to prevent contact between at least a portion of the body material and a biocompatible filler material, the sheath comprising a sheath material substantially resistant to at least one of the biocompatible filler material and a chemical component of the biocompatible filler material.

2. The system of claim 1, further comprising:

the hollow member.

3. The system of claim 1, wherein the body material comprises a compliant body material.

4. The system of claim 1, wherein the body material comprises a polyurethane-based material.

5. The system of claim 1, wherein the expansible body is configured to have a predetermined expanded dimension.

6. The system of claim 5, wherein at least the expansible body is selected from a plurality of expansible bodies, each configured to have a unique predetermined expanded dimension.

7. The system of claim 1, wherein the sheath is configured to have a predetermined expanded dimension.

8. The system of claim 7, wherein at least the sheath is selected from a plurality of sheaths, each configured to have a unique predetermined expanded dimension.

9. The system of claim 7, wherein the distal end of the elongate member comprises a first distal end, the hollow member comprises a second distal end, and the sheath is configured to be expanded from a first dimension to the predetermined expanded dimension when extended to a point beyond the second distal end.

10. The system of claim 9, wherein at least the sheath is configured to be contracted from the predetermined expanded dimension to the first dimension when brought within the second distal end from the point beyond the second distal end.

11. The system of claim 1, wherein the expansible body is configured to maintain a dimension of a treatment area while at least a portion of the treatment area is filled with the biocompatible filler material.

12. The system of claim 1, wherein the sheath material comprises a substantially non-compliant material.

13. The system of claim 1, wherein the sheath material comprises a rupture-resistant material.

14. The system of claim 1, wherein the sheath material is configured to substantially resist adhesion to the biocompatible filler material.

15. The system of claim 1, wherein the sheath material is configured to substantially adhere to the biocompatible filler material.

16. The system of claim 1, wherein at least a portion of the expansible body comprises a therapeutic material configured to provide a therapeutic effect to a treatment area.

17. The system of claim 1, wherein the biocompatible filler material comprises a therapeutic material.

18. The system of claim 1, wherein the expansible body is configured to be expanded with at least one of the following:

a gaseous material and a liquid material.

19. The system of claim 1, wherein the sheath is configured to collapse as the expansible body contracts.

20. The system of claim 1, wherein the elongate member comprises a bore extending therethrough.

21. The system of claim 20, wherein the bore is configured to receive a surgical tool.

22. The system of claim 1, wherein the sheath material is non-porous.

23. A system comprising:

an elongate member comprising a distal end; and

an expansible body comprising a body material, the expansible body disposed at the distal end of the elongate member and configured to be maneuverable along a path established by a hollow member;

a coating disposed on at least a portion of the expansible body, the coating configured to prevent contact between at least a portion of the body material and a biocompatible filler material, the coating comprising a coating material substantially resistant to at least one of the biocompatible filler material and a chemical component of the biocompatible filler material.

24. The system of claim 23, wherein the coating material is configured to substantially resist adhesion to the biocompatible filler material.

25. The system of claim 23, wherein the coating material is configured to substantially adhere to the biocompatible filler material.

26. The system of claim 23, wherein at least a portion of the expansible body comprises a therapeutic material configured to provide a therapeutic effect to a treatment area.

27. The system of claim 23, wherein the biocompatible filler material comprises a therapeutic material.

28. The system of claim 23, wherein the expansible body is configured to be expanded with at least one of the following:

a gaseous material and a liquid material.

29. The system of claim 23, wherein the body material comprises a polyurethane-based material.

30. A system comprising:

an elongate member comprising a distal end; and

a first expansible body comprising a first body material substantially resistant to at least one of a biocompatible filler material and a chemical component of the biocompatible filler material, the first expansible body disposed at the distal end of the elongate member and configured to be maneuverable along a path established by a hollow member;

a second expansible body disposed within the first expansible body and comprising a second body material.

31. The system of claim 30, wherein the second body material comprises a compliant material.

32. The system of claim 30, wherein the first expansible body is coupled to the second expansible body.

33. The system of claim 30, wherein the first expansible body is configured to prevent contact between at least a portion of the second expansible body and the biocompatible filler material.

34. The system of claim 30, wherein the first expansible body is configured to expand as the second expansible body expands.

35. The system of claim 30, wherein the first expansible body may be at least partly expanded independent of the second expansible body.

36. The system of claim 30, wherein at least one of the first expansible body and the second expansible body is configured to maintain a dimension of a treatment area while at least a portion of the treatment area is filled with the biocompatible filler material.

37. The system of claim 30, wherein the first body material comprises a substantially non-compliant material.

38. The system of claim 30, wherein the first body material comprises a rupture-resistant material.

39. The system of claim 30, wherein the first body material is configured to substantially resist adhesion to the biocompatible filler material.

40. The system of claim 30, wherein the first body material is configured to substantially adhere to the biocompatible filler material.

41. The system of claim 30, wherein at least a portion of the first expansible body comprises a therapeutic material configured to provide a therapeutic effect to a treatment area.

42. The system of claim 30, wherein the biocompatible filler material comprises a therapeutic material.

43. The system of claim 30, wherein the second expansible body is configured to be expanded with at least one of the following:

a gaseous material and a liquid material.

44. The system of claim 30, wherein the first expansible body is configured to collapse as the second expansible body contracts.

45. The system of claim 30, wherein the elongate member comprises a bore extending therethrough.

46. The system of claim 45, wherein the bore is configured to receive a surgical tool.

47. The system of claim 30, wherein the first body material is non-porous.

48. The system of claim 30, wherein the second body material comprises a polyurethane-based material.

49. A method comprising:

inserting an expansible body into a treatment area along a path established by a hollow member, the expansible body comprising a body material substantially resistant to at least one of a biocompatible filler material and a chemical component of the biocompatible filler material;

expanding the expansible body within the treatment area; and

inserting the biocompatible filler material into the treatment area while the expansible body is expanded.

50. The method of claim 49, further comprising:

collapsing the expansible body; and

removing the expansible body from the treatment area along the path established by the hollow member.

51. The method of claim 49, wherein the expansible body is configured to have a predetermined expanded dimension, and wherein expanding the expansible body within the treatment area further comprises expanding the expansible body to the predetermined expanded dimension.

52. The method of claim 49, further comprising:

selecting the expansible body from a plurality of expansible bodies, each configured to have a unique predetermined expanded dimension.

53. The method of claim 49, wherein the expansible body comprises a first expansible body, and further comprising:

inserting a second expansible body into the treatment area along the path established by the hollow member.

54. The method of claim 53, further comprising:

providing a cavity within the treatment area by expanding the second expansible body; and

removing the second expansible body from the treatment area prior to inserting the first expansible body into the treatment area, and wherein expanding the first expansible body within the treatment area comprises expanding the first expansible body within the cavity.

55. The method of claim 53, wherein the second expansible body is disposed within the first expansible body.

56. The method of claim 53, wherein expanding the first expansible body within the treatment area comprises expanding the second expansible body within the first expansible body.

57. The method of claim 56, wherein the second expansible body comprises a polyurethane-based body material.

58. The method of claim 49, wherein expanding the expansible body within the treatment area comprises at least partially filling the expansible body with at least one of the following:

a gaseous material and a liquid material.

59. The method of claim 49, wherein the hollow member comprises a first hollow member, and wherein inserting the biocompatible filler material into the treatment area comprises inserting the biocompatible filler material through a second hollow member.

60. The method of claim 49, further comprising:

applying a coating material to at least a portion of the expansible body, the coating material configured to substantially resist adhesion to the biocompatible filler material.

61. The method of claim 49, further comprising:

applying a coating material to at least a portion of the expansible body, the coating material configured to substantially adhere to the biocompatible filler material.

62. The method of claim 49, wherein at least a portion of the expansible body further comprises a coating material configured to substantially resist adhesion to the biocompatible filler material.

63. The method of claim 49, wherein at least a portion of the expansible body further comprises a coating material configured to substantially adhere to the biocompatible filler material.

64. The method of claim 49, further comprising:

applying a therapeutic material to at least a portion of the expansible body; and

introducing the therapeutic material to the treatment area with the expansible body.

65. The method of claim 49, wherein at least a portion of the expansible body further comprises a therapeutic material.

66. The method of claim 49, wherein the body material is non-porous.

67. A method comprising:

providing a cavity in a treatment area with a plurality of tools;

removing at least a first tool of the plurality of tools from the treatment area;

inserting an expansible body into the treatment area along a path established by a hollow member, the expansible body comprising a body material substantially resistant to at least one of a biocompatible filler material and a chemical component of the biocompatible filler material;

expanding the expansible body within the cavity; and

inserting the biocompatible filler material into the treatment area while the expansible body is expanded.

68. The method of claim 67, further comprising:

removing at least a second tool of the plurality of tools from the treatment area after inserting the expansible body into the treatment area.

69. The method of claim 67, further comprising:

collapsing the expansible body; and

removing the expansible body from the treatment area along the path established by the hollow member.

70. The method of claim 67, wherein the expansible body is configured to have a predetermined expanded dimension, and wherein expanding the expansible body within the cavity further comprises expanding the expansible body to the predetermined expanded dimension.

71. The method of claim 67, further comprising:

selecting the expansible body from a plurality of expansible bodies, each configured to have a unique predetermined expanded dimension.

72. The method of claim 67, wherein expanding the expansible body within the cavity comprises at least partially filling the expansible body with at least one of the following:

a gaseous material and a liquid material.

73. The method of claim 67, wherein the hollow member comprises a first hollow member, and wherein inserting the biocompatible filler material into the treatment area comprises inserting the biocompatible filler material through a second hollow member.

74. The method of claim 67, further comprising:

applying a coating material to at least a portion of the expansible body, the coating material configured to substantially resist adhesion to the biocompatible filler material.

75. The method of claim 67, further comprising:

applying a coating material to at least a portion of the expansible body, the coating material configured to substantially adhere to the biocompatible filler material.

76. The method of claim 67, wherein at least a portion of the expansible body further comprises a coating material configured to substantially resist adhesion to the biocompatible filler material.

77. The method of claim 67, wherein at least a portion of the expansible body further comprises a coating material configured to substantially adhere to the biocompatible filler material.

78. The method of claim 67, further comprising:

applying a therapeutic material to at least a portion of the expansible body; and

introducing the therapeutic material to the treatment area with the expansible body.

79. The method of claim 67, wherein at least a portion of the expansible body further comprises a therapeutic material.

80. The method of claim 67, wherein the body material is non-porous.