Inflatable implant

• US 7,632,291 B2
• Filed: 06/13/2003
• Issued: 12/15/2009
• Est. Priority Date: 06/13/2003
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Martin, Gerald Ray, Stephens, W. Patrick
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/461,853
• Publication Number:
  US 20040254625A1
• Time in Patent Office: 2,377 Days
• Field of Search: 606/191, 606/192, 606/194, 604/96.01, 604/97.01, 623/17.12, 623/17.11, 623/23.68
• US Class Current: 606/195
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12195 comprising a curable material

Abstract

Described is an inflatable implant suitable for placement in the human body and left there for an indeterminate and potentially lengthy period of time. The implant is one that has a low profile when introduced into the body and a larger profile when it is inflated with one or more filler materials. Depending upon design and use choices the delivered implant may be removable and adjustable in situ in size, position, location, form, and rigidity. Indeed, in some variations, the design of the implant may be such that it may be removed at a potentially fairly lengthy time after implantation. The implant includes at least one bladder wall that generally is at least partially non-elastic (or unexpandable) after the preselected size is reached. The bladder wall will define at least one fillable volume and may form more than one independent fillable volumes. The bladder wall, in some variations, may be partially elastic or expandable to permit adjustment of implant size or configuration after or during delivery. The implant may be used as a supporting structure in a variety of differing body tissues and structures, e.g., in the spine or as a prosthetic in plastic surgery. The implant may also be used in conjunction with other components (often having a springed bias) as a source of movement in controlling the opening of a lumen or duct, that is to say, as a type of on-off valve or as a controlled flow valve. The implant may be used as an occludant within, or adjacent to, a variety of natural or abnormal anatomical body openings, e.g., vascular and genital lumina, aneurysms, ducts, septal defects, fistulae, esophagus, etc. The wall and filler material may be selected to deliver treatment materials the locale of the implant site or to remove amounts of harmful materials from such a region. The implant may, with an appropriate filler material or bladder wall material, be used in cooperation with an appropriate radio frequency (RF) source to cause the increase of a localized internal temperature and a resulting tissue change such as coagulation, ablation, or the like. Methods of using the implant are also described.

Claims

1. An inflatable, expandable implant suitable for implantation in a human body, comprising:

a.) a bladder having a substantially non-elastic bladder wall defining a volume, having at least one bladder wall opening for introduction of filler material, and the bladder having no passageway exterior to the bladder wall for passage of a body fluid from an end of the bladder to another end of the bladder, and b.) at least one closure for each of the at least one bladder wall openings configured to close a respective bladder wall opening and maintain the filler material within the volume after introduction of the filler material into the volume.

2. The implant of claim 1 where the implant is configured to at least partially close a body opening in a human body by implantation in or adjacent to that body opening.

3. The implant of claim 2 where the implant is configured to at least partially close a body opening comprising a body lumen.

4. The implant of claim 2 where the implant is configured to at least partially close a body lumen selected from vascular lumen, genito-urinary lumen, bronchial lumen, gastrointestinal lumen, and hepatic lumen.

5. The implant of claim 2 where the implant is further configured, non-surgically and controllably to open and to at least partially close the body opening.

6. The implant of claim 1 where the implant is configured to support a body component in a human body by implantation adjacent that body component.

7. The implant of claim 1 where the implant is configured to support a body component comprising skin.

8. The implant of claim 1 where the implant is configured to support a body component comprising one or more body joint components.

9. The implant of claim 1 where the implant is configured to support one or more body joint component selected from components of the knee, spine, elbow, and wrist.

10. The implant of claim 1 where the implant further comprises a retrieving member, adapted to cooperate with a retriever, allowing removal of the implant from the body by access of the retriever through the body lumen and removal through that body lumen.

11. The implant of claim 1 where the retrieving member comprises an integral retrieving member, adapted to cooperate with a retriever, allowing removal of the implant from the body by access of the retriever through the body lumen and removal through that body lumen.

12. The implant of claim 1 further comprising the filler material.

13. The implant of claim 12 wherein the filler material is a filling liquid.

14. The implant of claim 13 wherein the filling liquid is selected from the group consisting of water, saline, and biocompatible liquids.

15. The implant of claim 12 wherein the filler material further contains a radiopaque material.

16. The implant of claim 12 wherein the filler material further contains a fluid radiopaque material.

17. The implant of claim 16 wherein the fluid radiopaque material comprises material selected from the group consisting of iopromide, metrizamide, and their mixtures and solutions.

18. The implant of claim 12 wherein the filler material further contains a solid radiopaque material.

19. The implant of claim 18 wherein the solid radiopaque material comprises one or more materials selected from the group consisting of barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, tantalum, gold, ruthenium, rhodium, osmium, iridium, palladium, platinum, rhenium, and their mixtures.

20. The implant of claim 12 wherein the filler material contains radio frequency energy absorbing material.

21. The implant of claim 12 wherein the filler material contains radio frequency energy absorbing material selected from the group consisting of iron oxides, iron hydroxides, graphite, and amorphous carbon.

22. The implant of claim 12 wherein the filler material contains radioactive material.

23. The implant of claim 12 wherein the filler material contains bioactive or chemi-active material.

24. The implant of claim 12 wherein the filler material comprises a reactive mixture adapted to react within the bladder volume.

25. The implant of claim 12 wherein the filler material comprises a member selected from the group consisting of elastic solids, viscoelastic solids, viscoelastic liquids, viscoelastic liquids comprising gel microparticles, viscous liquids, and their precursors.

26. The implant of claim 12 wherein the filler material comprises a copolymer of a first member selected from the group consisting of poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(ethylene-co-vinyl alcohol), poly(acrylic acid), poly(ethylene-co-acrylic acid), poly(ethyloxazoline), poly(vinyl pyrrolidone), poly(ethylene-co-vinyl pyrrolidone), poly(maleic acid), poly(ethylene-co-maleic acid), poly(acrylamide), and poly(ethylene oxide)-co-poly(propylene oxide) block copolymers and a second member having a strong nucleophile selected from the group consisting of a thiol or a group containing a thiol.

27. The implant of claim 1 further where the bladder wall is configured to maintain the implant in a selected position in the human body after introduction of a filler into the volume.

28. The implant of claim 1 further where the bladder wall is configured to form a preselected shape after introduction of a filler into the volume.

29. The implant of claim 1 further comprising at least one anchor configured to maintain the implant in a selected position in the human body after introduction of a filler into the volume.

30. The implant of claim 1 further comprising at least one anchoring region exterior to the bladder wall and configured to maintain the implant in a selected position in the human body after introduction of a filling fluid into the volume.

31. The implant of claim 1 further comprising at least one stent anchoring region fixed to the bladder wall and configured to maintain the implant in a selected position in the human body after introduction of a filling fluid into the volume.

32. The implant of claim 31 where the stent is self-expanding upon deployment.

33. The implant of claim 1 where the bladder wall comprises fabric selected from the group consisting of woven fabric and non-woven fabric.

34. The implant of claim 1 where the bladder wall comprises at least one member selected from the group consisting of polyethyleneterephthalate, polyvinylchloride, polyurethanes, polyolefins, polyamides, and fluoropolymers.

35. The implant of claim 1 where the bladder wall comprises at least one fluoropolymer selected from the group consisting of polytetrafluoroethylene, poly(ethylene-chlorofluoroethylene), poly(fluorinated ethylene propylene), polyperfluoroalkoxy, polychlorotrifluoroethylene, polyvinylfluoride, polyvinylidenefluoride, and expanded polytetrafluoroethylene.

36. The implant of claim 1 where the bladder wall comprises expanded polytetrafluoroethylene.

37. The implant of claim 1 where the bladder wall comprises one or more members selected from the group consisting of carbon fiber, metal fiber, and alloy fiber.

38. The implant of claim 1 where the bladder wall comprises a plurality of hollow fibers.

39. The implant of claim 1 further comprising at least an additional bladder having a substantially non-elastic bladder wall, the bladder wall for each respective additional bladder defining an additional volume, each respective additional bladder wall having at least one bladder wall opening for introduction of a filler, and at least one closure for each of the additional at least one bladder wall openings for maintaining filling fluid within the additional volumes.

40. The implant of claim 1 further comprising at least an additional bladder having an elastic bladder wall, the bladder wall for each respective additional bladder defining an additional volume, each respective additional bladder wall having at least one bladder wall opening for introduction of a filler, and at least one closure for each of the additional at least one bladder wall openings for maintaining filling fluid within the additional volumes.

41. The implant of claim 2 where the bladder wall is configured to block an opening in a septal wall upon inflation of the implant.

42. The implant of claim 41 where the bladder wall, after inflation with a filler material, includes a necked-down portion between two larger portions and where the necked down portion is sized to fit within the opening in the septal wall.

86. The implant of claim 1, wherein the bladder wall is configured to be multi-lobed prior to introduction of the filler material into the volume.

43. An inflatable, expandable implant suitable for implantation in a human body, comprising:

a.) a bladder having a substantially non-elastic bladder wall comprising an expanded polytetrafluoroethylene fabric, the bladder wall defining a volume, having at least one bladder wall opening for introduction of a filler, and having no passageway exterior to the bladder wall for passage of a body fluid from an end of the bladder to another end of the bladder, b.) at least one closure for each of the at least one bladder wall openings configured to close a respective bladder wall opening and maintain filling fluid within the volume after introduction of a filler material into the volume, and c.) the filler material comprising a member selected from the group consisting of elastic solids, viscoelastic solids, viscoelastic liquids, viscoelastic liquids comprising gel microparticles, viscous liquids, and precursors thereof.

44. The implant of claim 43 where the implant is configured to at least partially close a body opening in a human body by implantation in or adjacent to that body opening.

45. The implant of claim 44 where the implant is configured to at least partially close a body opening comprising a body lumen.

46. The implant of claim 44 where the implant is configured to at least partially close a body lumen selected from vascular lumen, genito-urinary lumen, bronchial lumen, gastrointestinal lumen, and hepatic lumen.

47. The implant of claim 44 where the implant is further configured, non-surgically and controllably to open and to at least partially close the body opening.

48. The implant of claim 43 where the bladder wall is configured to block an opening in a septal wall upon inflation of the implant.

49. The implant of claim 48 where the bladder wall, after inflation with a filler material, includes a necked-down portion between two larger portions and where the necked down portion is sized to fit within the opening in the septal wall.

50. The implant of claim 43 where the implant is configured to support a body component in a human body by implantation adjacent that body component.

51. The implant of claim 43 where the implant is configured to support a body component comprising skin.

52. The implant of claim 43 where the implant is configured to support a body component comprising one or more body joint components.

53. The implant of claim 43 where the implant is configured to support one or more body joint components selected from components of the knee, spine, elbow, and wrist.

54. The implant of claim 43 where the implant further comprises a retrieving member, adapted to cooperate with a retriever, allowing removal of the implant from the body by access of the retriever through the body lumen and removal through that body lumen.

55. The implant of claim 54 where the retrieving member comprises an integral retrieving member, adapted to cooperate with a retriever, allowing removal of the implant from the body by access of the retriever through the body lumen and removal through that body lumen.

56. The implant of claim 43 wherein the filler material further contains a radiopaque material.

57. The implant of claim 43 wherein the filler material further contains a fluid radiopaque material.

58. The implant of claim 57 wherein the fluid radiopaque material comprises material selected from the group consisting of iopromide, metrizamide, and their mixtures and solutions.

59. The implant of claim 43 wherein the filler material further contains a solid radiopaque material.

60. The implant of claim 59 wherein the solid radiopaque material comprises one or more materials selected from the group consisting of barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, tantalum, gold, ruthenium, rhodium, osmium, iridium, palladium, platinum, rhenium, and their mixtures.

61. The implant of claim 43 wherein the filler material contains radio frequency energy absorbing material.

62. The implant of claim 43 wherein the filler material contains radio frequency energy absorbing material selected from the group consisting of iron oxides, iron hydroxides, graphite, and amorphous carbon.

63. The implant of claim 43 wherein the filler material contains radioactive material.

64. The implant of claim 43 wherein the filler material contains bioactive or chemi-active material.

65. The implant of claim 43 further comprising at least one anchor configured to maintain the implant in a selected position in the human body after introduction of a filler into the volume.

66. The implant of claim 43 further comprising at least one anchoring region exterior to the bladder wall and configured to maintain the implant in a selected position in the human body after introduction of a filling fluid into the volume.

67. The implant of claim 43 further comprising at least one stent anchoring region fixed to the bladder wall and configured to maintain the implant in a selected position in the human body after introduction of a filling fluid into the volume.

68. The implant of claim 43 where the bladder wall comprises fabric selected from the group consisting of woven fabric and non-woven fabric.

69. The implant of claim 43 where the bladder wall comprises one or more members selected from the group consisting of carbon fiber, metal fiber, and alloy fiber.

70. The implant of claim 43 where the bladder wall comprises a plurality of hollow fibers.

71. The implant of claim 43 further comprising at least an additional bladder having a substantially non-elastic bladder wall, the bladder wall for each respective additional bladder defining an additional volume, each respective additional bladder wall having at least one bladder wall opening for introduction of a filler, and at least one closure for each of the additional at least one bladder wall openings for maintaining filling fluid within the additional volumes.

72. The implant of claim 43 further comprising at least an additional bladder having an elastic bladder wall, the bladder wall for each respective additional bladder defining an additional volume, each respective additional bladder wall having at least one bladder wall opening for introduction of a filler, and at least one closure for each of the additional at least one bladder wall openings for maintaining filling fluid within the additional volumes.

73. An inflatable, expandable implant suitable for raising a localized, interior temperature in a human body, comprising:

a.) a bladder having a substantially non-elastic bladder wall defining a bladder volume, having at least one bladder wall opening for introduction of filler material, b.) at least one closure for each of the at least one bladder wall openings configured to close a respective bladder wall opening and maintain the filler material within the volume after introduction of the filler material into the volume, and c.) the filler material, and wherein at least one of the bladder wall and the filler material comprises a radio frequency energy absorbing material.

74. The implant of claim 73 wherein the bladder wall comprises a radio frequency energy absorbing material.

75. The implant of claim 73 wherein the filler material comprises a radio frequency energy absorbing material.

76. The implant of claim 73 wherein each of the bladder wall and the filler material comprise a radio frequency energy absorbing material.

77. The implant of claim 75 wherein the filler material contains radio frequency energy absorbing material selected from the group consisting of iron oxides, iron hydroxides, graphite, and amorphous carbon.

78. The implant of claim 73 wherein the filler material further contains a radiopaque material.

79. The implant of claim 73 wherein the filler material comprises a reactive mixture adapted to react in the bladder volume.

80. The implant of claim 79 wherein the filler material comprises a member selected from the group consisting of elastic solids, viscoelastic solids, viscoelastic liquids, viscoelastic liquids comprising gel microparticles, viscous liquids, and their precursors.

81. The implant of claim 80 wherein the filler material comprises a copolymer of a first member selected from the group consisting of poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(ethylene-co-vinyl alcohol), poly(acrylic acid), poly(ethylene-co-acrylic acid), poly(ethyloxazoline), poly(vinyl pyrrolidone), poly(ethylene-co-vinyl pyrrolidone), poly(maleic acid), poly(ethylene-co-maleic acid), poly(acrylamide), and poly(ethylene oxide)-co-poly(propylene oxide) block copolymers and a second member having a strong nucleophile selected from the group consisting of a thiol or a group containing a thiol.

82. The implant of claim 73 where the bladder wall comprises fabric selected from the group consisting of woven fabric and non-woven fabric.

83. The implant of claim 73 where the bladder wall comprises at least one member selected from the group consisting of polyethyleneterephthalate, polyvinylchloride, polyurethanes, polyolefins, polyamides, and fluoropolymers.

84. The implant of claim 73 where the bladder wall comprises at least one fluoropolymer selected from the group consisting of polytetrafluoroethylene, poly(ethylene-chlorofluoroethylene), poly(fluorinated ethylene propylene), polyperfluoroalkoxy, polychlorotrifluoroethylene, polyvinylfluoride, polyvinylidenefluoride, and expanded polytetrafluoroethylene.

85. The implant of claim 73 where the bladder wall comprises expanded polytetrafluoroethylene.