Tissue augmentation device

• US 7,641,688 B2
• Filed: 12/22/2005
• Issued: 01/05/2010
• Est. Priority Date: 09/16/2004
• Status: Expired due to Fees

• Current Assignee: Evera Medical, Inc.
• Original Assignee: Evera Medical, Inc.
• Inventors: Lesh, Michael
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/316,215
• Publication Number:
  US 20060161253A1
• Time in Patent Office: 1,475 Days
• Field of Search: 623/1.11, 623/2.11, 623 1711- 1712, 623/23.72, 623/11.11, 604/892, 606/61, 606/192
• US Class Current: 623/11.11
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

Disclosed are implantable tissue augmentation devices, methods, and associated tools. The devices include an inflatable body, having an inner layer and an outer layer. A valve is provided for permitting the introduction of and retaining inflation media. At least one pull tab is provided on an end of the implant, to assist in positioning the implant. Kits and systems are also disclosed.

Claims

1. An implantable tissue augmentation device, comprising:

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

a valved opening on the proximal end;

a closed distal end;

a first, inner layer for retaining inflation media within the implant, and a second, outer microporous layer for enabling tissue ingrowth; and

at least one grasping means to allow positioning of the device at a desired site, wherein the grasping means comprises at least one tab.

2. The tissue augmentation device of claim 1, wherein the at least one tab comprises an aperture for connection to a suture.

3. The tissue augmentation device of claim 1, wherein the outer layer comprises ePTFE and the inner layer comprises at least one of silicone, polyurethane, or a thermoplastic elastomer.

4. The tissue augmentation device of claim 1, wherein the inflation media comprises one or more fluids.

5. The tissue augmentation device of claim 4, wherein said one or more fluids comprises saline.

6. The tissue augmentation device of claim 1, including a filler comprising a material that can be manually shaped to a desired configuration before the filler transforms to retain a molded configuration.

7. The tissue augmentation device of claim 1, wherein the tissue augmentation device permits passage of a fill tube, but at least substantially reseals following removal of the fill tube.

8. The tissue augmentation device of claim 1, wherein the tissue augmentation device comprises a plurality of internal baffles which divide an interior cavity of the device into a plurality of compartments.

9. The tissue augmentation device of claim 1, wherein said device comprises at least two compartments that are adapted to be filled separately in order to vary the contour of the filled region.

10. The tissue augmentation device of claim 1, wherein introduction of the inflation media transforms the device from a first configuration to a second configuration, wherein the second configuration has a diameter at an axial midpoint of about 1 mm to about 10 mm.

11. The tissue augmentation device of claim 10, wherein an inflatable portion of the device has a length within the range of from about 1 cm to about 6 cm.

12. The tissue augmentation device of claim 10, wherein said device has a diameter within the range of from about 1 mm to about 8 mm.

13. The tissue augmentation device of claim 1, wherein said device has a wall thickness within the range of from about 0.003 inches to about 0.020 inches.

14. The tissue augmentation device of claim 10, wherein the first configuration of said device has a diameter of less than about 1.6 mm.

15. The tissue augmentation device of claim 1, further comprising one suture.

16. An augmentation system comprising the tissue augmentation device of claim 1, and a dissection tool to separate tissue beneath a treatment site and create an implantation space.

17. A tissue augmentation system comprising the tissue augmentation device of claim 1, and a fill tube for introducing the inflation media.

18. A kit including a plurality tissue augmentation devices of claim 1, wherein said plurality of tissue augmentation devices is provided in a plurality of sizes to permit the user to select a desired size.

19. The kit of claim 18, wherein at least one of the tissue augmentation devices has a fully inflated diameter of:

1-10 mm.

20. An implantable tissue augmentation device for treating facial wrinkles, comprising:

an elongate, flexible tubular body, having a proximal end, a distal end and a cavity, wherein the tubular body has a first cross-section and a second cross-section;

the first cross-section having a cross-sectional area that is at least 110% of the second cross-section;

a valved opening on the proximal end;

a closed distal end;

a first configuration and a second configuration, wherein said tissue augmentation device is transformable from the first configuration to the second configuration by introduction of a filler into the cavity via the valved opening; and

an inner layer and an outer layer, wherein the outer layer comprises a porous material to encourage fibrous ingrowth and wherein the inner layer comprises an elastomeric material that adds flexibility to the body and is for contact with the filler material, wherein the inner and outer layers are bonded together.

21. The tissue augmentation device of claim 20, wherein the tubular body comprises a tapered portion between the first and second cross-section.

22. The tissue augmentation device of claim 20, wherein the tubular body comprises an accelerated curve shape between the first and second cross-section.

23. The tissue augmentation device of claim 20, wherein the tubular body comprises a progressive curve shape between the first and second cross-section.

24. The tissue augmentation device of claim 20, wherein the valved opening further comprises a tube surrounded by an elastomeric material.

25. The tissue augmentation device of claim 24, further comprising a valve plug.

26. The tissue augmentation device of claim 20, where the valved opening further comprises an additional sealing element.

27. The tissue augmentation device of claim 20, further comprising an unbonded zone between the inner and outer layers.

28. The tissue augmentation device of claim 27, where the length of the unbonded zone is at least 10% of the length of the device.

29. The tissue augmentation device of claim 20, wherein the outer layer and inner layers are configured to have substantial compliance matching with native surrounding tissues.

30. The tissue augmentation device of claim 20, further comprising a distal tab.

31. The tissue augmentation device of claim 30, said distal tab provided with a through passage.

32. The tissue augmentation device of claim 30, said distal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

33. The tissue augmentation device of claim 20, further comprising a proximal tab.

34. The tissue augmentation device of claim 33, the proximal tab providing a fixation zone for the valved opening.

35. The tissue augmentation device of claim 33, said proximal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

36. The tissue augmentation device of claim 20, said device having an axial length of 1-10 cm.

37. The tissue augmentation device of claim 20, said device having an axial length of 2-4 cm.

38. The tissue augmentation device of claim 20 said device having a maximum fill volume of 10-25 cc.

39. An implantable tissue augmentation device, comprising:

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

a valved opening on the proximal end;

a closed distal end;

a first, inner layer for retaining inflation media within the implant, and a second, outer microporous layer for enabling tissue ingrowth; and

a filler comprising a material that can be manually shaped to a desired configuration before the filler transforms to retain a molded configuration.

40. The tissue augmentation device of claim 39, wherein the device comprises at least one grasping means to allow positioning of the device at a desired site.

41. The tissue augmentation device of claim 40, wherein the grasping means comprises at least one tab.

42. The tissue augmentation device of claim 41, wherein the at least one tab comprises an aperture for connection to a suture.

43. The tissue augmentation device of claim 39, wherein the outer layer comprises ePTFE and the inner layer comprises at least one of silicone, polyurethane, or a thermoplastic elastomer.

44. The tissue augmentation device of claim 39, wherein the inflation media comprises one or more fluids.

45. The tissue augmentation device of claim 44, wherein said one or more fluids comprises saline.

46. The tissue augmentation device of claim 39, wherein the tissue augmentation device permits passage of a fill tube, but at least substantially reseals following removal of the fill tube.

47. The tissue augmentation device of claim 39, wherein the tissue augmentation device comprises a plurality of internal baffles which divide an interior cavity of the device into a plurality of compartments.

48. The tissue augmentation device of claim 39, wherein said device comprises at least two compartments that are adapted to be filled separately in order to vary the contour of the filled region.

49. The tissue augmentation device of claim 39, wherein introduction of the inflation media transforms the device from a first configuration to a second configuration, wherein the second configuration has a diameter at an axial midpoint of about 1 mm to about 10 mm.

50. The tissue augmentation device of claim 49, wherein an inflatable portion of the device has a length within the range of from about 1 cm to about 6 cm.

51. The tissue augmentation device of claim 49, wherein said device has a diameter within the range of from about 1 mm to about 8 mm.

52. The tissue augmentation device of claim 39, wherein said device has a wall thickness within the range of from about 0.003 inches to about 0.020 inches.

53. The tissue augmentation device of claim 49, wherein the first configuration of said device has a diameter of less than about 1.6 mm.

54. The tissue augmentation device of claim 39, further comprising one suture.

55. An augmentation system comprising the tissue augmentation device of claim 39, and a dissection tool to separate tissue beneath a treatment site and create an implantation space.

56. A tissue augmentation system comprising the tissue augmentation device of claim 39, and a fill tube for introducing the inflation media.

57. A kit including a plurality tissue augmentation devices of claim 39, wherein said plurality of tissue augmentation devices is provided in a plurality of sizes to permit the user to select a desired size.

58. The kit of claim 57, wherein at least one of the tissue augmentation devices has a fully inflated diameter of 1-10 mm.

59. An implantable tissue augmentation device for treating facial wrinkles, comprising:

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

a valved opening on the proximal end comprising a tube surrounded by an elastomeric material;

a valve plug;

a closed distal end;

a first configuration and a second configuration, wherein said tissue augmentation device is transformable from the first configuration to the second configuration by introduction of a filler into the cavity via the valved opening; and

an inner layer and an outer layer, wherein the outer layer comprises a porous material to encourage fibrous ingrowth and wherein the inner layer comprises an elastomeric material that adds flexibility to the body and is for contact with the filler material, wherein the inner and outer layers are bonded together.

60. The tissue augmentation device of claim 59, wherein the tubular body has a first cross-section and a second cross-section;

the first cross-section having a cross-sectional area that is at least 110% of the second cross-section.

61. The tissue augmentation device of claim 59, wherein the tubular body comprises a tapered portion between the first and second cross-section.

62. The tissue augmentation device of claim 59, wherein the tubular body comprises an accelerated curve shape between the first and second cross-section.

63. The tissue augmentation device of claim 59, wherein the tubular body comprises a progressive curve shape between the first and second cross-section.

64. The tissue augmentation device of claim 59, where the valved opening further comprises an additional sealing element.

65. The tissue augmentation device of claim 59, further comprising an unbonded zone between the inner and outer layers.

66. The tissue augmentation device of claim 65, where the length of the unbonded zone is at least 10% of the length of the device.

67. The tissue augmentation device of claim 59, wherein the outer layer and inner layers are configured to have substantial compliance matching with native surrounding tissues.

68. The tissue augmentation device of claim 59, further comprising a distal tab.

69. The tissue augmentation device of claim 68, said distal tab provided with a through passage.

70. The tissue augmentation device of claim 68, said distal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

71. The tissue augmentation device of claim 59, further comprising a proximal tab.

72. The tissue augmentation device of claim 71, the proximal tab providing a fixation zone for the valved opening.

73. The tissue augmentation device of claim 71, said proximal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

74. The tissue augmentation device of claim 59, said device having an axial length of 1-10 cm.

75. The tissue augmentation device of claim 59, said device having an axial length of 2-4 cm.

76. The tissue augmentation device of claim 59 said device having a maximum fill volume of 10-25 cc.

77. An implantable tissue augmentation device for treating facial wrinkles, comprising:

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

a valved opening on the proximal end;

a closed distal end;

a first configuration and a second configuration, wherein said tissue augmentation device is transformable from the first configuration to the second configuration by introduction of a filler into the cavity via the valved opening;

an inner layer and an outer layer, wherein the outer layer comprises a porous material to encourage fibrous ingrowth and wherein the inner layer comprises an elastomeric material that adds flexibility to the body and is for contact with the filler material, wherein the inner and outer layers are bonded together; and

an unbonded zone between the inner and outer layers.

78. The tissue augmentation device of claim 77, wherein the tubular body has a first cross-section and a second cross-section;

the first cross-section having a cross-sectional area that is at least 110% of the second cross-section.

79. The tissue augmentation device of claim 77, wherein the tubular body comprises a tapered portion between the first and second cross-section.

80. The tissue augmentation device of claim 77, wherein the tubular body comprises an accelerated curve shape between the first and second cross-section.

81. The tissue augmentation device of claim 77, wherein the tubular body comprises a progressive curve shape between the first and second cross-section.

82. The tissue augmentation device of claim 77, wherein the valved opening further comprises a tube surrounded by an elastomeric material.

83. The tissue augmentation device of claim 82, further comprising a valve plug.

84. The tissue augmentation device of claim 77, where the valved opening further comprises an additional sealing element.

85. The tissue augmentation device of claim 77, where the length of the unbonded zone is at least 10% of the length of the device.

86. The tissue augmentation device of claim 77, wherein the outer layer and inner layers are configured to have substantial compliance matching with native surrounding tissues.

87. The tissue augmentation device of claim 77, further comprising a distal tab.

88. The tissue augmentation device of claim 87, said distal tab provided with a through passage.

89. The tissue augmentation device of claim 87, said distal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

90. The tissue augmentation device of claim 77, further comprising a proximal tab.

91. The tissue augmentation device of claim 90, the proximal tab providing a fixation zone for the valved opening.

92. The tissue augmentation device of claim 90, said proximal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

93. The tissue augmentation device of claim 77, said device having an axial length of 1-10 cm.

94. The tissue augmentation device of claim 77, said device having an axial length of 2-4 cm.

95. The tissue augmentation device of claim 77 said device having a maximum fill volume of 10-25 cc.

96. An implantable tissue augmentation device for treating facial wrinkles, comprising:

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

a valved opening on the proximal end;

a closed distal end;

a distal tab;

a first configuration and a second configuration, wherein said tissue augmentation device is transformable from the first configuration to the second configuration by introduction of a filler into the cavity via the valved opening; and

an inner layer and an outer layer, wherein the outer layer comprises a porous material to encourage fibrous ingrowth and wherein the inner layer comprises an elastomeric material that adds flexibility to the body and is for contact with the filler material, wherein the inner and outer layers are bonded together.

97. The tissue augmentation device of claim 96, wherein the tubular body has a first cross-section and a second cross-section;

the first cross-section having a cross-sectional area that is at least 110% of the second cross-section.

98. The tissue augmentation device of claim 96, wherein the tubular body comprises a tapered portion between the first and second cross-section.

99. The tissue augmentation device of claim 96, wherein the tubular body comprises an accelerated curve shape between the first and second cross-section.

100. The tissue augmentation device of claim 96, wherein the tubular body comprises a progressive curve shape between the first and second cross-section.

101. The tissue augmentation device of claim 96, wherein the valved opening further comprises a tube surrounded by an elastomeric material.

102. The tissue augmentation device of claim 101, further comprising a valve plug.

103. The tissue augmentation device of claim 96, where the valved opening further comprises an additional sealing element.

104. The tissue augmentation device of claim 96, further comprising an unbonded zone between the inner and outer layers.

105. The tissue augmentation device of claim 104, where the length of the unbonded zone is at least 10% of the length of the device.

106. The tissue augmentation device of claim 96, wherein the outer layer and inner layers are configured to have substantial compliance matching with native surrounding tissues.

107. The tissue augmentation device of claim 96, said distal tab provided with a through passage.

108. The tissue augmentation device of claim 96, said distal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

109. The tissue augmentation device of claim 96, further comprising a proximal tab.

110. The tissue augmentation device of claim 109, the proximal tab providing a fixation zone for the valved opening.

111. The tissue augmentation device of claim 109, said proximal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

112. The tissue augmentation device of claim 96, said device having an axial length of 1-10 cm.

113. The tissue augmentation device of claim 96, said device having an axial length of 2-4 cm.

114. The tissue augmentation device of claim 96 said device having a maximum fill volume of 10-25 cc.

115. An implantable tissue augmentation device for treating facial wrinkles, comprising:

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

a valved opening on the proximal end;

a closed distal end;

a proximal tab;

a first configuration and a second configuration, wherein said tissue augmentation device is transformable from the first configuration to the second configuration by introduction of a filler into the cavity via the valved opening; and

an inner layer and an outer layer, wherein the outer layer comprises a porous material to encourage fibrous ingrowth and wherein the inner layer comprises an elastomeric material that adds flexibility to the body and is for contact with the filler material, wherein the inner and outer layers are bonded together.

116. The tissue augmentation device of claim 115, wherein the tubular body has a first cross-section and a second cross-section;

the first cross-section having a cross-sectional area that is at least 110% of the second cross-section.

117. The tissue augmentation device of claim 115, wherein the tubular body comprises a tapered portion between the first and second cross-section.

118. The tissue augmentation device of claim 115, wherein the tubular body comprises an accelerated curve shape between the first and second cross-section.

119. The tissue augmentation device of claim 115, wherein the tubular body comprises a progressive curve shape between the first and second cross-section.

120. The tissue augmentation device of claim 115, wherein the valved opening further comprises a tube surrounded by an elastomeric material.

121. The tissue augmentation device of claim 120, further comprising a valve plug.

122. The tissue augmentation device of claim 115, where the valved opening further comprises an additional sealing element.

123. The tissue augmentation device of claim 115, further comprising an unbonded zone between the inner and outer layers.

124. The tissue augmentation device of claim 123, where the length of the unbonded zone is at least 10% of the length of the device.

125. The tissue augmentation device of claim 115, wherein the outer layer and inner layers are configured to have substantial compliance matching with native surrounding tissues.

126. The tissue augmentation device of claim 115, further comprising a distal tab.

127. The tissue augmentation device of claim 126, said distal tab provided with a through passage.

128. The tissue augmentation device of claim 126, said distal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

129. The tissue augmentation device of claim 115, the proximal tab providing a fixation zone for the valved opening.

130. The tissue augmentation device of claim 115, said proximal tab measuring about 2.25±

1.25 mm in width and 0.5±

0.25 mm in thickness.

131. The tissue augmentation device of claim 115, said device having an axial length of 1-10 cm.

132. The tissue augmentation device of claim 115, said device having an axial length of 2-4 cm.

133. The tissue augmentation device of claim 115 said device having a maximum fill volume of 10-25 cc.