Airway implant and methods of making and using

• US 20060060207A1
• Filed: 09/21/2004
• Published: 03/23/2006
• Est. Priority Date: 09/21/2004
• Status: Active Grant

• Current Assignee: Pavad Medical, Inc.
• Original Assignee: Pavad Medical, Inc.
• Inventors: Hegde, Anant V., Buch, Wally S., Choi, George S.
• Granted Patent: US 7,836,888 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61C 7/00 Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
• CPC Class Codes: A61F 2/00 Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: Y10S 602/902 Antisnoring or mouth closing devices

Abstract

A system and device for maintaining and/or creating patency in airways is disclosed. The methods of using the system and device are also disclosed. The system includes a power source that energizes a electro-active polymer implant. The energized polymer implant provides stiffness and shape to the airway, thereby minimizing collapse or deformation of the airway. A method of making the device is also disclosed.

Claims

1. An implantable device for maintaining and/or creating airway patency of a biological subject, comprising:

a patency element comprising an electro-active polymer.

2. The device of claim 1, wherein the electro-active polymer comprises an ion exchange polymer.

3. The device of claim 1, wherein the electro-active polymer comprises an ion exchange polymer metal composite.

4. The device of claim 1, wherein the electro-active polymer comprises an ionomer base material.

5. The device of claim 1, wherein the electro-active polymer comprises perfluorinated polymer.

6. The device of claim 1, wherein the electro-active polymer comprises polytetrafluoroethylene.

7. The device of claim 1, wherein the electro-active polymer comprises polyfluorosulfonic acid.

8. The device of claim 1, wherein the electro-active polymer comprises perfluorosulfonate.

9. The device of claim 1, wherein the electro-active polymer comprises polyvinylidene fluoride.

10. The device of claim 1, wherein the electro-active polymer comprises hydrophilic polyvinylidene fluoride.

11. The device of claim 1, wherein the electro-active polymer comprises polyethylene.

12. The device of claim 1, wherein the electro-active polymer comprises polypropylene.

13. The device of claim 1, wherein the electro-active polymer comprises polystyrene.

14. The device of claim 1, wherein the electro-active polymer comprises polyaniline.

15. The device of claim 1, wherein the electro-active polymer comprises polyacrylonitrile.

16. The device of claim 1, wherein the electro-active polymer comprises cellophane.

17. The device of claim 1, wherein the electro-active polymer comprises cellulose.

18. The device of claim 1, wherein the electro-active polymer comprises regenerated cellulose.

19. The device of claim 1, wherein the electro-active polymer comprises cellulose acetate.

20. The device of claim 1, wherein the electro-active polymer comprises polysulfone.

21. The device of claim 1, wherein the electro-active polymer comprises polyurethane.

22. The device of claim 1, wherein the electro-active polymer comprises polyvinyl alcohol.

23. The device of claim 1, wherein the electro-active polymer comprises polyvinyl acetate.

24. The device of claim 1, wherein the electro-active polymer comprises polyvinyl pyrrolidone.

25. The device of claim 1, wherein the electro-active polymer comprises a biocompatible conductive material.

26. The device of claim 25, wherein the biocompatible conductive material comprises platinum.

27. The device of claim 25, wherein the biocompatible conductive material comprises gold.

28. The device of claim 25, wherein the biocompatible conductive material comprises silver.

29. The device of claim 25, wherein the biocompatible conductive material comprises palladium.

30. The device of claim 25, wherein the biocompatible conductive material comprises copper.

31. The device of claim 25, wherein the biocompatible conductive material comprises carbon.

32. The device of claim 1, wherein the patency element comprises a three dimensional shape.

33. The device of claim 1, wherein the patency element comprises a substantially rectangular shape.

34. The device of claim 1, wherein the patency element comprises a substantially triangular shape.

35. The device of claim 1, wherein the patency element comprises a substantially round shape.

36. The device of claim 1, wherein the patency element comprises a substantially trapezoidal shape.

37. The device of claim 1, wherein the patency element comprises a shape slots that are perpendicular to the axis.

38. The device of claim 1, wherein the patency element comprises slots that are parallel to the longitudinal axis.

39. The device of claim 1, wherein the patency element comprises a flat strip.

40. The device of claim 1, wherein the patency element comprises a rod.

41. The device of claim 1, wherein the patency element comprises a cylindrical tube

42. The device of claim 1, wherein the patency element comprises an arch.

43. The device of claim 42, wherein the arch has a uniform thickness.

44. The device of claim 42, wherein the arch has a varying thickness.

45. The device of claim 1, wherein the patency element comprises a coil.

46. The device of claim 1, wherein the patency element comprises perforations.

47. The device of claim 1, wherein the patency element comprises slots.

48. The device of claim 1, wherein the patency element comprises a first layer of the electroactive polymer.

49. The device of claim 48, wherein the patency element comprises a second layer of the electroactive polymer.

50. The device of claim 48, wherein the patency element comprises an insulation layer separating the first layer of the electroactive polymer from the second layer of the electroactive polymer.

51. The device of claim 50, wherein the insulation layer comprises silicone.

52. The device of claim 50, wherein the insulation layer comprises polyurethane.

53. The device of claim 50, wherein the insulation layer comprises polyimide.

54. The device of claim 50, wherein the insulation layer comprises nylon.

55. The device of claim 50, wherein the insulation layer comprises polyester.

56. The device of claim 50, wherein the insulation layer comprises polymethylmethacrylate.

57. The device of claim 50, wherein the insulation layer comprises polyethylmethacrylate.

58. The device of claim 50, wherein the insulation layer comprises neoprene.

59. The device of claim 50, wherein the insulation layer comprises styrene butadiene styrene.

60. The device of claim 50, wherein the insulation layer comprises polyvinyl acetate.

61. The device of claim 1, wherein the patency element has a non-energized configuration, and wherein the patency element is soft in the non-energized configuration.

62. The device of claim 1, wherein the patency element has an energized configuration, and wherein the patency element in the energized configuration is stiffer than the patency element in the non-energized configuration.

63. The device of claim 1, wherein the patency element has a pre-set non-energized configuration, and wherein the patency element is soft in the pre-set non-energized configuration.

64. The device of claim 63, wherein the pre-set non-energized configuration is substantially similar to the geometry of the patient'"'"'s airway where the device is implanted.

65. The device of claim 64, wherein the patency element has a pre-set energized configuration when the patency element is energized, and wherein the patency element in the pre-set energized configuration is stiffer than the patency element in the pre-set non-energized configuration.

66. The device of claim 63, wherein the patency element in the pre-set non-energized configuration is substantially equal to the patency element in the energized configuration.

67. The device of claim 66, wherein the pre-set non-energized configuration is substantially similar to the geometry of the airway where the device is implanted.

68. The device of claim 1, wherein the patency element comprises a coating.

69. The device of claim 68, wherein the coating isolates the patency element from body fluids.

70. The device of claim 68, wherein the coating'"'"'s dielectric strength is sufficient enough to electrically isolate the patency element.

71. The device of claim 68, wherein the coating is configured to minimize tissue growth on the patency element.

72. The device of claim 68, wherein the coating is configured to promote tissue growth on the patency element.

73. The device of claim 68, wherein the coating comprises poly-L-lysine.

74. The device of claim 68, wherein the coating comprises poly-D-lysine.

75. The device of claim 68, wherein the coating comprises polyethylene glycol.

76. The device of claim 68, wherein the coating comprises polyvinyl alcohol.

77. The device of claim 68, wherein the coating comprises polyvinyl acetate.

78. The device of claim 68, wherein the coating comprises hyaluronic acid.

79. The device of claim 68, wherein the coating comprises methylmethacrylate.

80. An implantable device for maintaining and/or creating patency of a lumen of a biological subject, comprising:

an electro-active patency element; and

an implantable transducer in electrical communication with the patency element.

81. The device of claim 80, wherein the lumen comprises an airway.

82. The device of claim 80, wherein the patency element comprises an electro-active polymer.

83. The device of claim 82, wherein the electro-active polymer comprises an ion exchange polymer-metal composite.

84. The device of claim 80, further comprising a conductive lead attached to the electro-active patency element and the implantable transducer.

85. The device of claim 80, further comprising a conductive lead in electrical communication with the electro-active patency element and the implantable transducer.

86. The device of claim 80, further comprising a power supply in electrical communication with the electro-active patency element.

87. The device of claim 86, wherein the power supply comprises a battery

88. The device of claim 86, wherein the power supply comprises a capacitor.

89. The device of claim 80, further comprising a battery in electrical communication with the implantable transducer.

90. The device of claim 80, further comprising a mouthpiece in communication with the implantable transducer.

91. The device of claim 90, wherein the mouthpiece comprises a dental retainer.

92. The device of claim 91, wherein the dental retainer comprising a induction coil and a power source.

93. The device of claim 92, wherein the power source is a disposable battery.

94. The device of claim 92, wherein the power source is a rechargeable battery.

95. The device of claim 91, wherein the dental retainer further comprising a pulse-width-modulation circuit.

96. the device of claim 91, wherein the dental retainer is custom fit for the individual biological subject.

97. The device of claim 90, wherein the mouthpiece is in conductive electrical communication with the implantable transducer.

98. The device of claim 90, wherein the mouthpiece is in inductive electrical communication with the implantable transducer.

99. The device of claim 80, wherein the implantable transducer comprises an inductive receiver.

100. The device of claim 99, wherein the inductive receiver comprises a coil.

101. The device of claim 80, wherein the implantable transducer comprises a conductive receiver.

102. The device of claim 101, wherein the conductive receiver comprises a dental filling.

103. The device of claim 101, wherein the conductive receiver comprises a dental implant.

104. The device of claim 101, wherein the conductive receiver implanted in the oral cavity.

105. The device of claim 101, wherein the conductive receiver implanted in the head and neck region of the biological subject.

106. The device of claim 80, further comprising a dermal patch in communication with the implantable transducer.

107. The device of claim 106, wherein the dermal patch comprises a coil, circuit and power source.

108. The device of claim 107, wherein the power source comprises a battery.

109. The device of claim 107, wherein the dermal patch further comprises a pulse-width-modulation circuit.

110. The device of claim 107, wherein the coil is in inductive communication with the patency element.

111. The device of claim 107, where in the coil is in conductive communication with the patency element.

112. A method for maintaining or creating airway patency in a biological subject, comprising:

implanting in the biological subject a patency element comprising an electro-active polymer;

energizing the patency element.

113. The method of claim 112, further comprising inserting a mouthpiece into the mouth of the biological subject.

114. The method of claim 112, wherein energizing the patency element comprises placing the patency element in electrical communication with a power supply.

115. The method of claim 114, wherein placing the patency element in electrical communication with a power supply comprises inserting a mouthpiece into the mouth of the biological subject.

116. The method of claim 114, wherein the electrical communication between the patency element and the power supply comprises inductive communication.

117. The method of claim 114, wherein the electrical communication between the patency element and the power supply comprises conductive communication.

118. The method of claim 112, further comprising implanting a transducer in the biological subject.

119. The method of claim 118, further comprising placing the transducer in electrical communication with the patency element.

120. The method of claim 118, wherein energizing the patency element comprises placing the transducer in electrical communication with a power supply.

121. The method of claim 112, further comprising implanting a power supply in the biological subject.

122. The method of claim 121, further comprising charging the power supply.

123. The method of claim 122, wherein charging the power supply comprises wearing a mouthpiece.

124. The method of claim 112, wherein the patency element is implanted at least in-part in a soft palate of the biological subject.

125. The method of claim 112, wherein the patency element is implanted at least in-part in an airway sidewall of the biological subject.

126. The method of claim 112, wherein the patency element is implanted at least in-part in a uvula of the biological subject.

127. The method of claim 112, wherein the patency element is implanted at least in-part in a pharynx wall of the biological subject.

128. The method of claim 112, wherein the patency element is implanted at least in-part in a trachea wall of the biological subject.

129. The method of claim 112, wherein the patency element is implanted at least in-part in a larynx wall of the biological subject.

130. The method of claim 112, wherein the patency element is implanted at least in-part in a nasal passage wall of the biological subject.

131. The method of claim 112, further comprising implanting a dental implant, wherein the dental implant is configured for electrical communication with the patency element.

132. The method of claim 112, further comprising filling a dental cavity with conductive dental filling for electrical communication with the patency element.

133. The method of claim 132, further comprising implanting a coil in the head and/or neck region of the biological subject.

134. The method of claim 133, wherein the coil is an inductive coil.

135. The method of claim 112, further comprises placement of a dermal patch for patency element activation.

136. A system for maintaining airway patency in a biological subject comprising:

an implantable patency element;

an implantable transducer;

an implantable lead wire connecting the patency element and the transducer;

a removable transducer; and

a removable power source;

and wherein the implantable patency element comprises an electroactive polymer.

137. The system of claim 136, further comprising a removable pulse-width-modulation circuit.

138. The system of claim 136 wherein the removable transducer and the removable power source are in a mouthpiece.

139. The system of claim 136, wherein the removable transducer and the removable power source are in a dermal patch.

140. The system of claim 136, wherein the electroactive polymer patency element comprises an ion exchange polymer metal composite material.

141. The system of claim 140, wherein the patency element comprises an ionomer and a conductive material.

142. The system of claim 141, wherein the ionomer comprising perfluorinated polymer

143. The system of claim 141, wherein the ionomer comprises polytetrafluoroethylene.

144. The system of claim 141, wherein the ionomer comprises polyfluorosulfonic acid.

145. The system of claim 141, wherein the ionomer comprises perfluorosulfonate.

146. The system of claim 141, wherein the ionomer comprises polyvinylidene fluoride.

147. The system of claim 141, wherein the ionomer comprises hydrophilic polyvinylidene fluoride.

148. The system of claim 141, wherein the ionomer comprises polyethylene.

149. The system of claim 141, wherein the ionomer comprises polypropylene.

150. The system of claim 141, wherein the ionomer comprises polystyrene.

151. The system of claim 141, wherein the ionomer comprises polyaniline

152. The system of claim 141, wherein the ionomer comprises polyacrylonitrile.

153. The system of claim 141, wherein the ionomer comprises cellophane.

154. The system of claim 141, wherein the ionomer comprises cellulose.

155. The system of claim 141, wherein the ionomer comprises regenerated cellulose.

156. The system of claim 141, wherein the ionomer comprises cellulose acetate.

157. The system of claim 141, wherein the ionomer comprises polysulfone.

158. The system of claim 141, wherein the ionomer comprises polyurethane.

159. The system of claim 141, wherein the ionomer comprises polyvinyl alcohol.

160. The system of claim 141, wherein the ionomer comprises polyvinyl acetate.

161. The system of claim 141, wherein the ionomer comprises polyvinyl pyrrolidone.

162. The system of claim 141, wherein the conductive material comprises platinum.

163. The system of claim 141, wherein the conductive material comprises gold.

164. The system of claim 141, wherein the conductive material comprises silver.

165. The system of claim 141, wherein the conductive material comprises palladium.

166. The system of claim 141, wherein the conductive material comprises copper.

167. The system of claim 141, wherein the conductive material comprises carbon.

168. The system of claim 136, further comprising a coating.

169. The system of claim 168, wherein the coating is on an implantable patency element and/or an implantable transducer and/or an implantable lead wire connecting the patency element and the transducer.

170. The system of claim 168, wherein the coating is only on the patency element.

171. The system of claim 168, wherein the coating comprises a dielectric coating.

172. The system of claim 171, wherein the dielectric coating comprises silicone.

173. The system of claim 171, wherein the dielectric coating comprises polyurethane.

174. The system of claim 171, wherein the dielectric coating comprises polyimide.

175. The system of claim 171, wherein the dielectric coating comprises nylon.

176. The system of claim 171, wherein the dielectric coating comprises polyester.

177. The system of claim 171, wherein the dielectric coating comprises polymethylmethacrylate.

178. The system of claim 171, wherein the dielectric coating comprises polyethylmethacrylate.

179. The system of claim 171, wherein the dielectric coating comprises neoprene.

180. The system of claim 171, wherein the dielectric coating comprises styrene butadiene styrene.

181. The system of claim 171, wherein the dielectric coating comprises polyvinyl acetate.

183. The system of claim 168, wherein the coating comprises a tissue growth promoting material.

184. The system of claim 183, wherein the tissue growth promoting material comprises poly-L-lysine.

185. The system of claim 183, wherein the tissue growth promoting material comprises poly-D-lysine.

186. The system of claim 183, wherein the tissue growth promoting material comprises polyethylene glycol.

187. The system of claim 183, wherein the tissue growth promoting material comprises polyvinyl alcohol.

188. The system of claim 183, wherein the tissue growth promoting material comprises polyvinyl acetate.

189. The system of claim 183, wherein the tissue growth promoting material comprises hyaluronic acid.

199. The system of claim 183, wherein the tissue growth promoting material comprises methylmethacrylate.

200. The system of claim 168, wherein the coating comprises a tissue growth preventing material.

201. The system of claim 200, wherein the tissue growth preventing material comprises polypropylene.

202. The system of claim 200, wherein the tissue growth preventing material comprises polyethylene.

204. The system of claim 200, wherein the tissue growth preventing material comprises hyaluronic acid.

206. The system of claim 200, wherein the tissue growth preventing material comprises polyvinylidene fluoride.

207. The system of claim 136, further comprising a battery charger.

208. A method for using an ion exchange polymer-metal composite comprising:

applying an electrical charge to the ion exchange polymer-metal composite.

209. A method for fabricating an ion exchange polymer metal composite patency element comprises:

shape forming the patency element, and

connecting a lead wire to the patency element.

210. The method of claim 209, wherein shape forming comprises shape forming an ion exchange polymer metal composite into the patency element.

211. The method of claim 209, wherein shape forming comprises cutting an ion exchange polymer metal composite sheet into a patency element shape.

212. The method of claim 209, wherein the shape forming comprises layering ion exchange polymer metal composite layers.

213. The method of claim 212, further comprising insulating the ion exchange polymer composite layers.

214. The method of claim 213, wherein the insulating layer comprises silicone.

215. The method of claim 213, wherein the insulating layer comprises polyurethane.

216. The method of claim 213, wherein the insulating layer comprises polyimide.

217. The method of claim 213, wherein the insulating layer comprises nylon.

218. The method of claim 213, wherein the insulating layer comprises polyester.

219. The method of claim 213, wherein the insulating layer comprises polymethylmethacrylate.

220. The method of claim 213, wherein the insulating layer comprises polyethylmethacrylate.

221. The method of claim 213, wherein the insulating layer comprises neoprene.

222. The method of claim 213, wherein the insulating layer comprises styrene.

223. The method of claim 213, wherein the insulating layer comprises styrene butadiene styrene.

224. The method of claim 213, wherein the insulating layer comprises polyvinyl acetate.

225. The method of claim 212, further comprises connecting the ion exchange polymer composite layer to a lead wire.

226. The method of claim 209, wherein shape forming comprises shape setting the ion exchange polymer into a pre-set shape.

227. The method of claim 209, further comprising fabricating an ion exchange polymer metal composite.

228. The method of claim 227, wherein fabricating the ion exchange polymer metal composite comprises grafting a conductive element to an ionomer.

229. The method of claim 228, wherein the conductive element comprises platinum

230. The method of claim 228, wherein the conductive element comprises gold.

231. The method of claim 228, wherein the conductive element comprises silver.

232. The method of claim 228, wherein the conductive element comprises palladium.

233. The method of claim 228, wherein the conductive element comprises copper.

234. The method of claim 228, wherein the conductive element comprises carbon.

235. The method of claim 228, wherein the ionomer comprises perfluironated polymer.

236. The method of claim 228, wherein the ionomer comprises polytetrafluoroethylene.

237. The method of claim 228, wherein the ionomer comprises polyfluorosulfonic acid.

238. The method of claim 228, wherein the ionomer comprises perfluorosulfonate.

239. The method of claim 228, wherein the ionomer comprises polyvinylidene fluoride.

240. The method of claim 228, wherein the ionomer comprises hydrophilic polyvinylidene fluoride.

241. The method of claim 228, wherein the ionomer comprises polyethylene.

242. The method of claim 228, wherein the ionomer comprises polypropylene.

243. The method of claim 228, wherein the ionomer comprises polystyrene.

244. The method of claim 228, wherein the ionomer comprises polyaniline.

245. The method of claim 228, wherein the ionomer comprises polyacrylonitrile.

246. The method of claim 228, wherein the ionomer comprises cellophane.

247. The method of claim 228, wherein the ionomer comprises cellulose.

248. The method of claim 228, wherein the ionomer comprises regenerated cellulose.

249. The method of claim 228, wherein the ionomer comprises cellulose acetate.

250. The method of claim 228, wherein the ionomer comprises polysulfone.

251. The method of claim 228, wherein the ionomer comprises polyurethane.

252. The method of claim 228, wherein the ionomer comprises polyvinyl alcohol.

253. The method of claim 228, wherein the ionomer comprises polyvinyl acetate.

254. The method of claim 228, wherein the ionomer comprises polyvinyl pyrrolidone.

255. The method of claim 209, further comprising coating the patency element.

256. The method of claim 255, wherein coating comprises applying a dielectric coating.

257. The method of claim 256, wherein the dielectric coating comprises silicone.

258. The method of claim 256, wherein the dielectric coating comprises polyurethane.

259. The method of claim 256, wherein the dielectric coating comprises polyimide.

260. The method of claim 256, wherein the dielectric coating comprises nylon.

261. The method of claim 256, wherein the dielectric coating comprises polyester.

262. The method of claim 256, wherein the dielectric coating comprises polymethylmethacrylate.

263. The method of claim 256, wherein the dielectric coating comprises polyethylmethacrylate.

264. The method of claim 256, wherein the dielectric coating comprises neoprene.

265. The method of claim 256, wherein the dielectric coating comprises styrene.

266. The method of claim 256, wherein the dielectric coating comprises styrene butadiene styrene.

267. The method of claim 256, wherein the dielectric coating comprises polyvinyl acetate.

268. The method of claim 255, wherein coating comprises applying a tissue growth promoting material.

269. The method of claim 268, wherein the tissue growth promoting material comprises poly-L-lysine.

270. The method of claim 268, wherein the tissue growth promoting material comprises poly-D-lysine.

271. The method of claim 268, wherein the tissue growth promoting material comprises polyethylene glycol.

272. The method of claim 268, wherein the tissue growth promoting material comprises polyvinyl alcohol.

273. The method of claim 268, wherein the tissue growth promoting material comprises polyvinyl acetate.

274. The method of claim 268, wherein the tissue growth promoting material comprises hyaluronic acid.

275. The method of claim 268, wherein the tissue growth promoting material comprises methylmethacrylate.

276. The method of claim 255, wherein coating comprises applying a tissue growth preventing material.

277. The method of claim 276, wherein the tissue growth preventing material comprises polypropylene.

278. The method of claim 276, wherein the tissue growth preventing material comprises polyethylene.

279. The method of claim 276, wherein the tissue growth preventing material comprises hyaluronic acid.

280. The method of claim 276, wherein the tissue growth preventing material comprises polyvinylidene fluoride.