Control of urge incontinence

• US 20050261746A1
• Filed: 09/24/2003
• Published: 11/24/2005
• Est. Priority Date: 10/06/1998
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Gross, Yossi, Cohen, Ehud, Lifschitz, David, Nissenkorn, Israel
• Granted Patent: US 7,582,053 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

A device (20) for treatment of a patient'"'"'s urinary incontinence, including a sensor, (44), which generates a signal responsive to a physiological characteristic indicative of a likelihood of incontinence. A control unit (22) receives the signal from the sensor. At least one electrode (29) is preferably implanted in the patient. The electrode is coupled to cause contraction of a pelvic muscle of the patient responsive to application of electrical energy to the electrode. Responsive to the signal, the control unit applies an electrical waveform to the electrode, so as to inhibit the incontinence.

Claims

1-166. -166. (canceled)

167. Apparatus comprising:

at least one electrode, adapted to be implanted in a patient in contact with a pelvic muscle of the patient; and

a control unit, adapted to drive the at least one electrode to apply an electrical waveform to the muscle, the control unit providing for the waveform a range of pulse width durations that includes 2 ms.

168. The apparatus according to claim 167, wherein the control unit is adapted to set the range of pulse width durations to be selectable from 0.1 ms to 2 ms.

169. The apparatus according to claim 167, wherein the at least one electrode is adapted to be implanted in the pelvic muscle.

170. The apparatus according to claim 167, wherein the pelvic muscle includes a pelvic floor muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic floor muscle.

171. The apparatus according to claim 167, wherein the pelvic muscle includes a levator ani muscle, and wherein the at least one electrode is adapted to be implanted in contact with the levator ani muscle.

172. The apparatus according to claim 167, wherein the pelvic muscle includes a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the urethral sphincter muscle.

173. The apparatus according to claim 167, wherein the pelvic muscle includes a pelvic muscle adjacent to a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic muscle adjacent to the urethral sphincter muscle.

174. The apparatus according to claim 167, wherein the at least one electrode comprises a single unipolar electrode.

175. The apparatus according to claim 167, wherein the at least one electrode comprises a pair of bipolar electrodes.

176. The apparatus according to claim 167, wherein the at least one electrode comprises a flexible intra-muscular electrode.

177. The apparatus according to claim 167, wherein the control unit is adapted to be implanted in a body of the patient.

178. The apparatus according to claim 167, wherein the control unit is adapted to configure the waveform to be biphasic.

179. The apparatus according to claim 167, wherein the at least one electrode comprises at least one elongated electrode structure, adapted to be implanted in general alignment with a urethra of the patient.

180. The apparatus according to claim 167, wherein the control unit is adapted to configure the waveform to treat urinary incontinence of the patient.

181. The apparatus according to claim 180, wherein the urinary incontinence includes urinary urge incontinence, and wherein the control unit is adapted to configure the waveform to treat the urinary urge incontinence.

182. The apparatus according to claim 180, wherein the urinary incontinence includes stress incontinence, and wherein the control unit is adapted to configure the waveform to treat the stress incontinence.

183. Apparatus comprising:

at least one electrode, adapted to be implanted in a patient in contact with a pelvic muscle of the patient; and

a control unit, adapted to drive the at least one electrode to apply a biphasic electrical waveform to the muscle.

184. The apparatus according to claim 183, wherein the at least one electrode is adapted to be implanted in the pelvic muscle.

185. The apparatus according to claim, 183, wherein the pelvic muscle includes a pelvic floor muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic floor muscle.

186. The apparatus according to claim 183, wherein the pelvic muscle includes a levator ani muscle, and wherein the at least one electrode is adapted to be implanted in contact with the elevator ani muscle.

187. The apparatus according to claim 183, wherein the pelvic muscle includes a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the urethral sphincter muscle.

188. The apparatus according to claim 183, wherein the pelvic muscle includes a pelvic muscle adjacent to a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic muscle adjacent to the urethral sphincter muscle.

189. The apparatus according to claim 183, wherein the at least one electrode comprises a flexible intra-muscular electrode.

190. The apparatus according to claim 183, wherein the at least one electrode comprises at least one elongated electrode structure, adapted to be implanted in general alignment with a urethra of the patient.

191. The apparatus according to claim 183, wherein the control unit is adapted to configure the waveform to treat incontinence of the patient.

192. The apparatus according to claim 191, wherein the urinary incontinence includes urinary urge incontinence, and wherein the control unit is adapted to configure the waveform to treat the urinary urge incontinence.

193. The apparatus according to claim 191, wherein the urinary incontinence includes stress incontinence, and wherein the control unit is adapted to configure the waveform to treat the stress incontinence.

194. Apparatus comprising:

at least one electrode, adapted to be implanted in a patient in a pelvic muscle of the patient selected from the list consisting of;

a levator ani muscle, and a urethral sphincter muscle; and

a control unit, adapted to drive the at least one electrode to apply an electrical waveform to the muscle.

195. The apparatus according to claim 194, wherein the pelvic muscle includes the levator ani muscle, and wherein the at least one electrode is adapted to be implanted in the levator ani muscle.

196. The apparatus according to claim 194, wherein the pelvic muscle includes the urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in the urethral sphincter muscle.

197. The apparatus according to claim 194, wherein the at least one electrode comprises a flexible intra-muscular electrode.

198. The apparatus according to claim 194, wherein the control unit is adapted to be implanted in a body of the patient.

199. The apparatus according to claim 194, wherein the at least one electrode comprises at least one elongated electrode structure, adapted to be implanted in general alignment with a urethra of the patient.

200. The apparatus according to claim 194, wherein the control unit is adapted to configure the waveform to treat urinary incontinence of the patient.

201. The apparatus according to claim 200, wherein the urinary incontinence includes urinary urge incontinence, and wherein the control unit is adapted to configure the waveform to treat the urinary urge incontinence.

202. The apparatus according to claim 200, wherein the urinary incontinence includes stress incontinence, and wherein the control unit is adapted to configure the waveform to treat the stress incontinence.

203. Apparatus comprising:

at least one electrode, adapted to be implanted in a patient in contact with a pelvic muscle of the patient; and

a control unit, adapted to;

drive the at least one electrode to apply an electrical waveform to the muscle, and

terminate application of the waveform after a predetermined period of time.

204. The apparatus according to claim 203, wherein the predetermined period of time is about 5 seconds.

205. The apparatus according to claim 203, wherein the control unit is adapted to drive the at least one electrode to reapply the waveform after termination of the application of the waveform.

206. The apparatus according to claim 203, wherein the at least one electrode is adapted to be implanted in the pelvic muscle.

207. The apparatus according to claim 203, wherein the pelvic muscle includes a pelvic floor muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic floor muscle.

208. The apparatus according to claim 203, wherein the pelvic muscle includes a levator ani muscle, and wherein the at least one electrode is adapted to be implanted in contact with the levator ani muscle.

209. The apparatus according to claim 203, wherein the pelvic muscle includes a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the urethral sphincter muscle.

210. The apparatus according to claim 203, wherein the pelvic muscle includes a pelvic muscle adjacent to a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic muscle adjacent to the urethral sphincter muscle.

211. The apparatus according to claim 203, wherein the at least one electrode comprises a single unipolar electrode.

212. The apparatus according to claim 203, wherein the at least one electrode comprises a pair of bipolar electrodes.

213. The apparatus according to claim 203, wherein the at least one electrode comprises a flexible intramuscular electrode.

214. The apparatus according to claim 203, wherein the control unit is adapted to be implanted in a body of the patient.

215. The apparatus according to claim 203, wherein the control unit is adapted to configure the waveform to be biphasic.

216. The apparatus according to claim 203, wherein the at least one electrode comprises at least one elongated electrode structure, adapted to be implanted in general alignment with a urethra of the patient.

217. The apparatus according to claim 203, wherein the control unit is adapted to provide for the waveform a range of pulse width durations that includes 2 ms.

218. The apparatus according to claim 217, wherein the control unit is adapted to set the range of pulse width durations to be selectable from 0.1 ms to 2 ms.

219. The apparatus according to claim 203, wherein the control unit is adapted to configure the waveform to treat urinary incontinence of the patient.

220. The apparatus according to claim 219, wherein the urinary incontinence includes urinary urge incontinence, and wherein the control unit is adapted to configure the waveform to treat the urinary urge incontinence.

221. The apparatus according to claim 219, wherein the urinary incontinence includes stress incontinence, and wherein the control unit is adapted to configure the waveform to treat the stress incontinence.

222. Apparatus comprising:

at least one electrode, adapted to be implanted in a patient in a pelvic muscle of the patient; and

a control unit, adapted to drive the at least one electrode to apply an electrical waveform to the muscle configured to treat a bladder condition caused by damage to nerve pathways from a brain to a bladder.

223. The apparatus according to claim 222, wherein the bladder condition includes urge incontinence.

224. The apparatus according to claim 222, wherein the pelvic muscle includes a pelvic floor muscle, and wherein the at least one electrode is adapted to be implanted in the pelvic floor muscle.

225. The apparatus according to claim 222, wherein the pelvic muscle includes a levator ani muscle, and wherein the at least one electrode is adapted to be implanted in the levator ani muscle.

226. The apparatus according to claim 222, wherein the pelvic muscle includes a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in the urethral sphincter muscle.

227. The apparatus according to claim 222, wherein the pelvic muscle includes a pelvic muscle adjacent to a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in the pelvic muscle adjacent to the urethral sphincter muscle.

228. The apparatus according to claim 222, wherein the at least one electrode comprises a single unipolar electrode.

229. The apparatus according to claim 222, wherein the at least one electrode comprises a pair of bipolar electrodes.

230. The apparatus according to claim 222, wherein the at least one electrode comprises a flexible intra-muscular electrode.

231. The apparatus according to claim 222, wherein the control unit is adapted to be implanted in a body of the patient.

232. The apparatus according to claim 222, wherein the control unit is adapted to configure the waveform to be biphasic.

233. The apparatus according to claim 222, wherein the at least one electrode comprises at least one elongated electrode structure, adapted to be implanted in general alignment with a urethra of the patient.

234. The apparatus according to claim 222, wherein the control unit is adapted to provide for the waveform a range of pulse width durations that includes 2 ms.

235. The apparatus according to claim 234, wherein the control unit is adapted to set the range of pulse width durations to be selectable from 0.1 ms to 2 ms.

236. Apparatus comprising:

at least one elongated electrode structure, adapted to be implanted, in general alignment with a urethra of a patient, in contact with a pelvic muscle of the patient; and

a control unit, adapted to drive the at least one electrode to apply an electrical waveform to the muscle.

237. The apparatus according to claim 236, wherein the at least one electrode is adapted to be implanted in the pelvic muscle.

238. The apparatus according to claim 236, wherein the pelvic muscle includes a pelvic floor muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic floor muscle.

239. The apparatus according to claim 236, wherein the pelvic muscle includes a levator ani muscle, and wherein the at least one electrode is adapted to be implanted in contact with the levator ani muscle.

240. The apparatus according to claim 236, wherein the pelvic muscle includes a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the urethral sphincter muscle.

241. The apparatus according to claim 236, wherein the pelvic muscle includes a pelvic muscle adjacent to a urethral sphincter muscle, and wherein the at least one electrode is adapted to be implanted in contact with the pelvic muscle adjacent to the urethral sphincter muscle.

242. The apparatus according to claim 236, wherein the at least one electrode comprises a flexible intra-muscular electrode.

243. A method comprising:

implanting at least one electrode in a patient in contact with a pelvic muscle of the patient;

driving the at least one electrode to apply an electrical waveform to the muscle; and

providing for the waveform a range of pulse width durations that includes 2 ms.

244. The method according to claim 243, wherein providing the range of pulse width durations comprises setting the range of pulse width durations to be selectable from 0.1 ms to 2 ms.

245. The method according to claim 243, wherein implanting the at least one electrode comprises implanting the at least one electrode in the pelvic muscle.

246. The method according to claim 243, wherein driving the at least one electrode comprises configuring the waveform to treat urinary incontinence of the patient.

247. The method according to claim 246, wherein the urinary incontinence includes urinary urge incontinence, and driving the at least one electrode comprises configuring the waveform to treat the urinary urge incontinence.

248. The method according to claim 246, wherein the urinary incontinence includes stress incontinence, and wherein driving the at least one electrode comprises configuring the waveform to treat the stress incontinence.

249. A method comprising:

implanting at least one electrode in a patient in contact with a pelvic muscle of the patient; and

driving the at least one electrode to apply a biphasic electrical waveform to the muscle.

250. The method according to claim 249, wherein implanting the at least one electrode comprises implanting the at least one electrode in the pelvic muscle.

251. The method according to claim 249, wherein driving the at least one electrode comprises configuring the waveform to treat urinary incontinence of the patient.

252. The method according to claim 251, wherein the urinary incontinence includes urinary urge incontinence, and driving the at least one electrode comprises configuring the waveform to treat the urinary urge incontinence.

253. The method according to claim 251, wherein the urinary incontinence includes stress incontinence, and wherein driving the at least one electrode comprises configuring the waveform to treat the stress incontinence.

254. A method comprising:

implanting at least one electrode in a patient in a pelvic muscle of the patient selected from the list consisting of a levator ani muscle, and a urethral sphincter muscle; and

driving the at least one electrode to apply an electrical waveform to the muscle.

255. The method according to claim 254, wherein the pelvic muscle includes the levator ani muscle, and wherein implanting the at least one electrode comprises implanting the at least one electrode in the levator ani muscle.

256. The method according to claim 254, wherein the pelvic muscle includes the urethral sphincter muscle, and wherein implanting the at least one electrode comprises implanting the at least one electrode in the urethral sphincter muscle.

257. The method according to claim 254, wherein driving the at least one electrode comprises configuring the waveform to treat urinary incontinence of the patient.

258. The method according to claim 257, wherein the urinary incontinence includes urinary urge incontinence, and driving the at least one electrode comprises configuring the waveform to treat the urinary urge incontinence.

259. The method according to claim 257, wherein, the urinary incontinence includes stress incontinence, and wherein driving the at least one electrode comprises configuring the waveform to treat the stress incontinence.

260. A method comprising:

implanting at least one electrode in a patient in contact with a pelvic muscle of the patient;

driving the at least one electrode to apply an electrical waveform to the muscle, and

terminating application of the waveform after a predetermined period of time.

261. The method according to claim 260, wherein the predetermined period of time is about 5 seconds.

262. The method according to claim 260, wherein driving the at least one electrode comprises driving the at least one electrode to reapply the waveform after termination of the application of the waveform.

263. The method according to claim 260, wherein implanting the at least one electrode comprises implanting the at least one electrode in the pelvic muscle.

264. The method according to claim 260, wherein driving the at least one electrode comprises providing for the waveform, a range of pulse width durations that includes 2 ms.

265. The method according to claim 264, wherein providing the range of pulse width durations comprises setting the range of pulse width durations to be selectable from 0.1 ms to 2 ms.

266. The method according to claim 260, wherein driving the at least one electrode comprises configuring the waveform to treat urinary incontinence of the patient.

267. The method according to claim 266, wherein the urinary incontinence includes urinary urge incontinence, and driving the at least one electrode comprises configuring the waveform to treat the urinary urge incontinence.

268. The method according to claim 266, wherein the urinary incontinence includes stress incontinence, and wherein driving the at least one electrode comprises configuring the waveform to treat the stress incontinence.

269. A method comprising:

implanting at least one electrode in a patient in a pelvic muscle of the patient; and

driving the at least one electrode to apply an electrical waveform to the muscle configured to treat a bladder condition caused by damage to nerve pathways from a brain to a bladder.

270. The method according to claim 269, wherein the bladder condition includes urge incontinence.

271. The method according to claim 269, wherein driving the at least one electrode comprises providing for the waveform a range of pulse width durations that includes 2 ms.

272. The method according to claim 271, wherein providing the range of pulse width durations comprises setting the range of pulse width durations to be selectable from 0.1 ms to 2 ms.

273. A method comprising:

implanting at least one elongated electrode structure in general alignment with a urethra of a patient, in contact with a pelvic muscle of the patient; and

driving the at least one electrode to apply an electrical waveform to the muscle.

274. The method according to claim 273, wherein implanting the at least one electrode comprises implanting the at least one electrode in the pelvic muscle.