Controlled penile prosthesis

• US 20060235482A1
• Filed: 05/22/2006
• Published: 10/19/2006
• Est. Priority Date: 02/14/2000
• Status: Active Grant

• Current Assignee: Obtech Medical AG
• Original Assignee: Obtech Medicalag
• Inventors: Forsell, Peter
• Granted Patent: US 8,126,558 B2
• Time in Patent Office: Days
• US Class Current: 607/39
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 5/41 Devices for promoting penis erection penis implants A61F2/26; massage of the genitals A61H19/00

Abstract

A male sexual impotence prosthesis apparatus comprises an operable prosthesis implanted in the cavities of the corpora cavemosa of a patient'"'"'s penile tissue for providing erect penile condition, when the prosthesis is operated. The prosthesis is operable by an implanted operation device. A control device is provided for controlling a source of energy, which may or may not be implanted, from outside the patient'"'"'s body, to release energy for use in connection with the operation of the prosthesis, i.e., to power the operation device. The patient uses the control device to operate the prosthesis to achieve erection.

Claims

1-142. -142. (canceled)

143. A male sexual impotence treatment prosthesis apparatus, comprising an operable penile prosthesis implantable in the cavities of the corpora cavernosa of a patient to provide erect penile condition, when the prosthesis is operated, comprising:

an external source of energy dapated to release wireless energy for use in connection with the operation of the prosthesis;

an implantable energy transforming device for transforming the wireless energy to storable energy;

an internal, implantable source of energy adapted to store the energy released from the external source of energy; and

a control device operable from outside the patient'"'"'s body is provided for controlling the internal source of energy to release energy for use in connection with the operation of the prosthesis, when the prosthesis is implanted.

144. An apparatus according to claim 143, wherein control device is adapted to control the external source of energy to release wireless energy for use in connection with the operation of the prosthesis.

145. An apparatus according to claim 143, wherein the control device controls the prosthesis.

146. An apparatus according to claim 145, wherein the control device comprises an internal control unit implantable in the patient for controlling the prosthesis.

147. An apparatus according to claim 146, wherein the internal control unit is programmable.

148. An apparatus according to claim 147, wherein the control device comprises an external control unit intended to be outside the patient'"'"'s body, the internal control unit being programmable by the external control unit.

149. An apparatus according to claim 147, wherein the internal control unit is programmable for controlling the prosthesis over time.

150. An apparatus according to claim 149, wherein the internal control unit controls the prosthesis over time in accordance with an activity schedule program.

151. An apparatus according to claim 149, wherein the internal control unit comprises a microprocessor.

152. An apparatus according to claim 148, wherein the external control unit loads the internal control unit with data in accordance with a loading mode only authorized for a doctor.

153. An apparatus according to claim 148, wherein the external control unit controls the internal control unit in accordance with a doctor mode only authorized for a doctor.

154. An apparatus according to claim 148, wherein the external control unit controls the internal control unit in accordance with a patient mode permitted for the patient.

155. An apparatus according to claim 143, wherein the implantable source of energy comprises at least one accumulator, at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

156. An apparatus according to claim 155, wherein the implantable source of energy comprises an electric source of energy.

157. An apparatus according to claim 156, wherein the electric source of energy comprises an accumulator, or a battery having a lifetime of at least 10 years.

158. An apparatus according to claim 143, wherein the control device controls the penile prosthesis.

159. An apparatus according to claim 143, wherein the implantable source of energy comprises an accumulator.

160. An apparatus according to claim 159, wherein the accumulator comprises an electric accumulator.

161. An apparatus according to claim 160, wherein the electric accumulator comprises at least one capacitor, or a combination of at least one capacitor and at least one rechargeable battery.

162. An apparatus according to claim 143, further comprising a battery implantable in the patient for supplying electric energy to implantable electric energy consuming components of the apparatus.

163. he apparatus according to claim 143, wherein the control device is adapted to control the external source of energy to release wireless energy for direct use in connection with the operation of the penile prosthesis.

164. The apparatus according to claim 163, wherein the control device is adapted to control the external source of energy to intermittently release wireless energy in the form of a train of energy pulses for direct use in connection with the operation of the penile prosthesis.

165. The apparatus according to claim 163, wherein the penile prosthesis is operable in a non-magnetic, non-thermal or non-mechanical manner by use of said released wireless energy.

166. The apparatus according to claim 143, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis.

167. The apparatus according to claim 166, wherein the switch directly or indirectly affects the supply of energy from the internal source of energy.

168. The apparatus according to claim 167, wherein the switch switches between an “

off”

mode, in which the internal source of energy is not in use, and an “

on”

mode, in which the internal source of energy supplies energy for the operation of the penile prosthesis.

169. The apparatus according to claim 143, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis, wherein the switch is operable by the wireless energy released from the external source of energy.

170. The apparatus according to claim 169, wherein the control device controls the external source of energy to release the wireless energy.

171. The apparatus according to claim 143, wherein the control device comprises a wireless remote control.

172. The apparatus according to claim 171, wherein the wireless remote is adapted to control the internal source of energy.

173. The apparatus according to claim 172, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis, wherein the switch is operable by the wireless energy from the external source of energy to switch between an “

off”

mode, in which the internal source of energy and remote control are not in use, and a “

standby”

mode, in which the remote control is permitted to control the internal source of energy to supply energy for the operation of the penile prosthesis.

174. The apparatus according to claim 171, wherein the control device controls the switch to switch between the “

on” and

“

off”

modes.

175. An apparatus according to claim 143, further comprising an operation device implantable in the patient for operating the penile prosthesis.

176. An apparatus according to claim 175, wherein the control device controls the operation device to operate the penile prosthesis.

177. An apparatus according to claim 175, wherein the operation device comprises hydraulic means and at least one valve for controlling a fluid flow in the hydraulic means.

178. An apparatus according to claim 177, wherein the control device comprises a wireless remote control for controlling the valve.

179. An apparatus according to claim 176, wherein the penile prosthesis comprises hydraulic means and the operation device comprises a reservoir forming a fluid chamber with a variable volume connected to the hydraulic means, and the operation device is adapted to distribute fluid from the chamber to the hydraulic means by reduction of the volume of the chamber and to withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.

180. An apparatus according to claim 143, wherein the operation device comprises a motor.

181. An apparatus according to claim 180, wherein the motor comprises a rotary motor, and the control device controls the rotary motor to rotate a desired number of revolutions.

182. An apparatus according to claim 180, wherein the motor comprises a linear motor.

183. An apparatus according to claim 180, wherein the motor comprises a hydraulic or pneumatic fluid motor, and the control device controls the fluid motor.

184. An apparatus according to claim 180, wherein the motor comprises an electric motor having electrically conductive parts made of plastics.

185. An apparatus according to claim 143, wherein the control device releases polarized energy from the internal source of energy.

186. An apparatus according to claim 176, wherein the control device shifts polarity of the released energy to reverse the operation device.

187. An apparatus according to claim 175, wherein the operation device comprises an electric motor and the released energy comprises electric energy.

188. An apparatus according to claim 143, wherein the penile prosthesis is operable to perform a reversible function.

189. An apparatus according to claim 188, further comprising a reversing device implantable in the patient for reversing the function performed by the penile prosthesis.

190. An apparatus according to claim 189, wherein the control device controls the reversing device to reverse the function performed by the penile prosthesis.

191. An apparatus according to claim 190, wherein the reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in the hydraulic means.

192. An apparatus according to claim 190, wherein the reversing device comprises a mechanical reversing device.

193. An apparatus according to claim 192, wherein the mechanical reversing device comprises a switch.

194. An apparatus according to claim 192, wherein the reversing device comprises a gearbox.

195. An apparatus according to claim 194, wherein the reversing device comprises a switch.

196. An apparatus according to claim 195, wherein the switch of the reversing device is operable by the released energy.

197. An apparatus according to claim 196, wherein the control device controls the operation of the switch of the reversing device by shifting polarity of the released energy supplied to the switch.

198. An apparatus according to claim 197, wherein the switch comprises an electric switch and the source of energy supplies electric energy for the operation of the switch.

199. An apparatus according to claim 195, wherein the operation device comprises a motor, and the reversing device reverses the motor.

200. An apparatus according to claim 143, further comprising an operation device implantable in the patient for operating the penile prosthesis.

201. An apparatus according to claim 200, wherein the penile prosthesis comprises hydraulic means and the operation device is adapted to conduct a hydraulic fluid in the hydraulic means.

202. An apparatus according to claim 201, wherein the operation device comprises a motor.

203. An apparatus according to claim 201, wherein the operation device comprises a fluid conduit connected to the hydraulic means of the penile prosthesis, and a reservoir for fluid, the reservoir forming part of the conduit.

204. An apparatus according to claim 203, wherein the hydraulic means and conduit are devoid of any non-return valve.

205. An apparatus according to claim 203, wherein the reservoir forms a fluid chamber with a variable volume, and the operation device is adapted to distribute fluid from the chamber to the hydraulic means of the penile prosthesis by reduction of the volume of the chamber and to withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.

206. An apparatus according to claim 143, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.

207. An apparatus according to claim 206, wherein the sensor is adapted to directly or indirectly sense as the physical parameter ejaculation or the pressure in the urethra.

208. An apparatus according to claim 206, wherein the control device controls the penile prosthesis in response to signals from the sensor.

209. An apparatus according to claim 208, wherein the control device comprises an internal control unit implantable in the patient, the internal control unit controlling the penile prosthesis in response to signals from the sensor.

210. An apparatus according to claim 209, wherein the control device comprises an external control unit outside the patient'"'"'s body, the external control unit controlling the penile prosthesis in response to signals from the sensor.

211. An apparatus according to claim 210, wherein the external control unit stores information on the physical parameter sensed by the sensor and is manually operated to control the penile prosthesis based on the stored information.

212. An apparatus according to claim 206, further comprising at least one implantable sender for sending information on the physical parameter sensed by the sensor.

213. An apparatus according to claim 143, further comprising an external data communicator intended to be outside the patient'"'"'s body and an internal data communicator implantable in the patient for communicating with the external communicator, wherein the internal data communicator feeds data related to the patient back to the external data communicator or the external data communicator feeds data to the internal data communicator.

214. An apparatus according to claim 213, wherein the internal data communicator feeds data related to the penile prosthesis.

215. An apparatus according to claim 213, wherein the implantable communicator feeds data related to at least one physical signal of the patient.

216. An apparatus according to claim 143, wherein the prosthesis is adapted to control the penis to change between flaccid and erect penile condition.

217. An apparatus according to claim 216, wherein the prosthesis is operable to erect the penis or to make it flaccid.

218. An apparatus according to claim 216, wherein the prosthesis is adapted to control the penis to steplessly change between flaccid and erect penile condition.

219. An apparatus according to claim 143, wherein the control device is adapted to control the external source of energy to release wireless electric energy and the energy transforming device is adapted to transform the electric energy into kinetic energy for operation of the prosthesis.

220. An apparatus according to claim 219, wherein the prosthesis is directly operated with the kinetic energy, as the energy transforming device transforms the electric energy into the kinetic energy.

221. An apparatus according to claim 143, wherein the prosthesis is non-inflatable.

222. An apparatus according to claim 143, wherein the control device controls the internal source of energy to release energy for a determined time period.

223. An apparatus according to claim 143, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.

224. An apparatus according to claim 143, wherein the control device is adapted to control the internal source of energy to release energy in a non-invasive manner.

225. An apparatus according to claim 143, wherein the control device comprises a wireless remote control for transmitting at least one wireless control signal for controlling the prosthesis.

226. An apparatus according to claim 225, wherein the remote control is capable of obtaining information on the condition of the prosthesis when the prosthesis is implanted and of controlling the prosthesis in response to the information.

227. An apparatus according to claim 225, wherein the wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient.

228. An apparatus according to claim 225, wherein the wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implantable in the patient.

229. An apparatus according to any of claims 226, wherein the remote control is capable of sending information related to the prosthesis from inside the patient'"'"'s body to the outside thereof.

230. An apparatus according to claim 229, wherein the remote control controls the prosthesis in response to the information.

231. An apparatus according to any of claims 225, wherein the remote control transmits a carrier signal for carrying the control signal.

232. An apparatus according to claim 231, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

233. An apparatus according to claim 231, wherein the carrier signal is digital, analog or digital and analog.

234. An apparatus according to claim 231, wherein the control signal used with the carrier signal is frequency, amplitude or frequency and amplitude modulated.

235. An apparatus according to any of claim 225, wherein the control signal comprises a wave signal comprising one of a sound wave signal including an ultrasound wave signal, an electromagnetic wave signal including an infrared light signal, a visible light signal, an ultra violet light signal and a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

236. An apparatus according to claim 225, wherein the control signal comprises an electric, a magnetic or an electric and magnetic field.

237. An apparatus according to any of claims 225, wherein the control signal is digital, analog or digital and analog.

238. An apparatus according to claim 237, wherein the remote control transmits an electromagnetic carrier wave signal for carrying the digital or analog control signal.

239. An apparatus according to any of claims 225, wherein the control signal is transmitted in pulses by the wireless remote control.

240. An apparatus according to claim 143, further comprising an implantable stabilizer for stabilizing the energy released by the control device.

241. An apparatus according to claim 240, wherein the energy released by the control device comprises electric energy and the stabilizer comprises at least one capacitor.

242. An apparatus according to claim 143, wherein the penile prosthesis is operable by the released energy in a manual, mechanical, thermal or magnetic manner.

243. An apparatus according to claim 143, wherein the penile prosthesis is operable by the released energy in a non-manual, non-mechanical, non-thermal or non-magnetic manner.

244. An apparatus according to claim 143, wherein the control device is adapted to control the source of energy to release electric energy, and further comprising an implantable capacitor for producing the train of energy pulses from the released energy.

245. An apparatus according to claim 143, further comprising an adjustment device for adjusting the penile prosthesis, wherein the adjustment device is adapted to mechanically adjust the penile prosthesis, or adapted to hydraulically adjust the penile prosthesis by using hydraulic means which is devoid of hydraulic fluid of the kind having a viscosity that substantially increases when exposed to heat or a magnetic field.

246. An apparatus according to claim 175, wherein the operation device comprises an electrical operation device.

247. An apparatus according to claim 175, wherein the operation device is powered by magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, thermal energy or non-thermal energy.

248. An apparatus according to claim 143, wherein the control device is activated in a manual or non-manual manner to control the source of energy to release energy.

249. An apparatus according to claim 143, further comprising implantable electrical components including at least one voltage level guard.

250. An apparatus according to claim 143, further comprising implantable electrical components including a single voltage level guard.

251. An apparatus according to claim 249, wherein the electrical components are devoid of any current detector and/or charge level detector.

252. An apparatus according to any of claims 249, further comprising an implantable capacitor or accumulator, wherein the charge or discharge of the capacitor or accumulator is controlled by use of the voltage level guard.

253. An apparatus according to claim 163, wherein the released energy comprises electric energy and further comprising an implantable capacitor for producing the train of energy pulses.

254. An apparatus according to claim 252, wherein the capacitor has a capacity less than 0,1 μ

F.

255. An apparatus according to any of claim 143, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the control device is adapted to control the source of energy to directly power the motor or pump with the released energy.

256. An apparatus according to claim 163, wherein the wireless energy comprises electromagnetic waves excluding radio waves.

257. An apparatus according to any of claims 143, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the control device is adapted to release wireless energy in the form of a magnetic field or electromagnetic waves for direct power of the motor or pump, as the wireless energy is being released.

258. An apparatus according to claim 257, wherein the pump is not a plunger type of pump.

259. An apparatus according to claim 143, wherein the wireless energy comprises a signal.

260. An apparatus according to claim 143, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for operation of the penile prosthesis.

261. An apparatus according to claim 260, wherein the energy transforming device transforms the wireless energy in the form of sound waves directly into electric energy.

262. An apparatus according to claim 260, wherein the energy transforming device comprises a capacitor.

263. An apparatus according to claim 262, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

264. An apparatus according to 260, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the motor or pump is powered by the transformed energy.

265. An apparatus according to claim 143, wherein the penile prosthesis is adjustable in a non-manual manner.

266. An apparatus according to claim 143, wherein the penile prosthesis is embedded in a soft or gel-like material.

267. An apparatus according to claim 266, wherein the penile prosthesis is embedded in a silicone material having hardness less than 20 Shore.

268. An apparatus according to claim 163, further comprising an activatable source of energy implantable in the patient, wherein the internal source of energy is activated by wireless energy released from the external source of energy, to supply energy which is used in connection with the operation of the restriction device.

269. An apparatus according to claim 143, wherein the prosthesis is reversibly adjustable between flaccid and erect penile conditions by displacing a hydraulic fluid into or from the cavities of copora cavernosa.

270. An apparatus according to claim 160, wherein the electric accumulator comprises at least one rechargeable battery.

271. A method of treating male sexual impotence, comprising:

implanting an operable implanted prosthesis in a patient, so that the implanted prosthesis engaging the corpus cavernosa or penile tissue or the prolongation thereof with feasibility to achieve erected or flaccid penile condition in a patient, implanting a source of energy for energizing the implanted prosthesis,

controlling the source of energy to release energy for use in connection with the operation of the implanted prosthesis,

distributing hydraulic fluid to corpora cavernosa to achieve erected penile conditions by using said released energy.

272. A method according to claim 271, further comprising using energy released from the source of energy to reversibly operate the implanted prosthesis to erect, respectively, flaccid the penis.

273. A method according to claim 271, wherein said source of energy is a rechargeable battery.

274. A method of treating male sexual impotence, comprising the steps of:

placing at least two laparascopical trocars in a patient'"'"'s body, inserting a dissecting tool through the trocars and dissecting an area of the penile tissue or the prolongation thereof, placing an operable prosthesis in the dissected area in engagement with the penile tissue or the prolongation thereof

implanting a source of energy in the patient, and

controlling the implanted source of energy from outside the patient'"'"'s body to release energy for use in connection with the operation of the implanted prosthesis.

275. A method of treating male sexual impotence, comprising the steps of:

placing at least two laparascopical trocars in a patient'"'"'s body,

inserting a dissecting tool through the trocars and dissecting an area of the penile tissue or the prolongation thereof, implanting an operable prosthesis device in the dissected area in engagement with the penile tissue or the prolongation thereof,

implanting an energy transfer device in the patient, providing an external source of energy and implanting an internal source of energy adapted to store wireless energy from said external source of energy,

controlling the external source of energy to release wireless energy,

transferring the wireless energy by the energy transfer device into energy for use in connection with the operation of the implanted prosthesis,

storing said wirelessly transferred energy in said internal source of energy, and

controlling the internal source of energy from outside the patient'"'"'s body to release energy for use in connection with the operation of the implanted prosthesis.

276. A method of treating an impotent male patient, comprising:

(a) surgically implanting in the male patient an operable implanted prosthesis engaging the corpus cavernosa or penile tissue or the prolongation thereof with feasibility to achieve erected or flaccid penile condition in a patient, an energy transfer device and an internal source of energy adapted to store wireless energy from an external source of energy,

(b) providing a source of energy external to the patient'"'"'s body, and

(c) controlling the external source of energy from outside the patient'"'"'s body to release wireless energy

(d) transferring the wireless energy by the energy transfer device into energy for use in connection with the operation of the implanted prosthesis

(e) storing said wirelessly transferred energy in said internal source of energy, and

(f) controlling the implanted source of energy from outside the patient'"'"'s body to release energy for use in connection with the operation of the implanted prosthesis

277. A method according to claim 276, further comprising implanting in the male patient an operation device which can reversibly adjust the implanted prosthesis in response to supplied energy.

278. A method according to claim 277, further comprising using the released wireless energy to activate the implanted operation device so as to operate the implanted operation device to achieve erected or flaccid penile condition.

279. A method of treating an impotent male patient, comprising the steps of:

placing at least two laparascopical trocars in the patient'"'"'s body, inserting a dissecting tool through the trocars and dissecting an area of the penile tissue or the prolongation thereof,

placing an operable prosthesis device in the dissected area, so that the implanted prosthesis engages the penile tissue or the prolongation thereof.

providing a source of energy outside the male patient'"'"'s body,

controlling the external source of energy from outside the patient'"'"'s body to release wireless energy, and

using the released wireless energy in connection with the operation of the implanted prosthesis

280. The method according to claim 279, further comprising the step of:

transferring the wireless energy by the energy transfer device into energy different than the wireless energy for use in connection with the operation of the prosthesis device.

281. A method according to claim 280, further comprising implanting a stabilizer in the male patient'"'"'s body for stabilizing the energy transferred by the energy transfer device.