Hydraulic anal incontinence treatment

• US 20070232848A1
• Filed: 05/10/2007
• Published: 10/04/2007
• Est. Priority Date: 02/14/2000
• Status: Active Grant

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Granted Patent: US 8,313,423 B2
• Time in Patent Office: Days
• US Class Current: 600/31
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61F 2/0018 magnetic
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An anal incontinence treatment apparatus and method includes and uses an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The restriction device engages the rectum of the patient to restrict the fecal passageway. An adjustment device is adapted to adjust the restriction device such that the rectum is temporarily released, in order to open the fecal passageway when the patient wishes to achieve defaecation.

Claims

1-111. -111. (canceled)

112. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

an energy transmission device for wireless transmission of energy from outside the patient'"'"'s body,

an energy transfer device adapted to be implanted in the patient for transferring energy transmitted by said energy transmission device into a different form energy, said restriction device being operable in response to said different form energy to vary the restriction of the restricted fecal passageway, and

an operation device adapted to be implanted in the patient for operating said restriction device,

wherein said different form energy is used for powering said operation device to operate said restriction device to close the fecal passageway to prevent feces to pass therethrough and to enlarge the fecal passageway to allow feces to readily pass therethrough.

113. An apparatus according to claim 112, wherein said energy transfer device is capable of supplying a direct current, a pulsating direct current or a combination of a direct current and pulsating direct current via conductors connected to said energy transfer device.

114. An apparatus according to claim 112, wherein said operation device comprises a linear motor.

115. An apparatus according to claim 112, further comprising a control device, and wherein said operation device comprises a hydraulic or pneumatic fluid motor, and said control device controls the said fluid motor.

116. An apparatus according to claim 112, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

117. An apparatus according to claim 116, wherein said operation device comprises a motor for driving said pump.

118. An apparatus according to claim 116, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

119. An apparatus according to claim 118, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

120. An apparatus according to claim 119, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

121. An apparatus according to claim 112, wherein said restriction device is operable to perform a reversible function.

122. An apparatus according to claim 112, wherein the energy transmitted by said energy transmission device comprises a magnetic field.

123. An apparatus according to claim 122, wherein said magnetic field is transmitted in pulses or digital pulses, or a combination of pulses and digital pulses by said energy transmission device.

124. An apparatus according to claim 112, wherein said energy transfer device transfers the energy transmitted by said energy transmission device into a direct current or pulsating direct current, or a combination of a direct current and a pulsating direct current.

125. An apparatus according to claim 112, wherein said energy transfer device transfers the energy transmitted by said energy transmission device into an alternating current or a combination of a direct and alternating current.

126. An apparatus according to claim 112, wherein said different form energy comprises a frequency or amplitude modulated signal, or a combination of a frequency and amplitude modulated signal.

127. An apparatus according to claim 112, wherein said different form energy comprises an analog or a digital signal, or a combination of an analog and digital signal.

128. An apparatus according to claim 112, wherein said operation device comprises hydraulic means and at least one valve for controlling a fluid flow in said hydraulic means.

129. An apparatus according to claim 128, further comprising a wireless remote control for controlling said valve.

130. An apparatus according to claim 112, wherein said restriction device is non-inflatable.

131. An apparatus according to claim 112, wherein one of the energy transmitted by said energy transmission device and said different form energy comprises kinetic energy.

154. An apparatus according to claim 124, wherein said restriction device is non-inflatable.

156. An apparatus according to claim 112, wherein said restriction device is non-inflatable.

132. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

an energy transmission device for wireless transmission of energy from outside the patient'"'"'s body,

an energy transfer device adapted to be implanted in the patient for transferring energy transmitted by said energy transmission device into a different form energy,

an energy storage device adapted to be implanted in the patient for storing said different form energy and for supplying energy for operation of said restriction device, and

a switch adapted to be implanted in the patient for directly or indirectly switching the supply of energy from said energy storage device, and

an operation device adapted to be implanted in the patient for operating said restriction device,

wherein said switch is inoperable by permanent magnets, and

wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

133. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

an energy transmission device for wireless transmission of energy from outside the patient'"'"'s body,

an energy transfer device adapted to be implanted in the patient for transferring energy transmitted by said energy transmission device into a different form energy,

wherein said restriction device is adapted to be directly operated to vary the restriction of the restricted fecal passageway, in response to said different form energy transferred by said energy transfer device, as said energy transmission device transmits energy, and

wherein said restriction device is operable to perform a reversible function.

134. An apparatus according to claim 133, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

135. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

a source of energy external to the patient'"'"'s body,

a control device operable from outside the patient'"'"'s body for releasing wireless energy from said source of energy without the use of permanent magnets, and

an energy transfer device for transferring the released wireless energy into an energy form suited for use in connection with the operation of said restriction device.

136. An apparatus according to claim 135, wherein said restriction device is non-inflatable.

137. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

a source of energy external to the patient'"'"'s body, and

a control device operable from outside the patient'"'"'s body for releasing wireless energy from said source of energy and transferring said released wireless energy into electric energy to be used in connection with the operation of said restriction device.

138. An apparatus according to claim 137, wherein said control device releases energy from said source of energy in a non-invasive manner.

139. An apparatus according to claim 137, wherein said control device releases magnetic energy.

140. An apparatus according to claim 137, wherein said control device releases electromagnetic energy.

141. An apparatus according to claim 137, wherein said control device releases kinetic energy.

142. An apparatus according to claim 137, wherein said control device releases energy from said source of energy in a mechanical manner.

143. An apparatus according to claim 137, wherein said control device releases non-magnetic energy.

144. An apparatus according to claim 137, wherein said control device releases non-electromagnetic energy.

145. An apparatus according to claim 137, wherein said control device releases non-kinetic energy.

146. An apparatus according to claim 137, wherein said control device releases or non-thermal energy.

147. An apparatus according to claim 137, wherein said control device releases energy from said source of energy in a non-mechanical manner.

148. An apparatus according to claim 137, wherein said control device directly powers said operation device with energy released from said source of energy and/or powers other implanted energy consuming components of the apparatus.

149. An apparatus according to claim 137, further comprising a motor implanted in the patient for operating said restriction device.

150. An apparatus according to claim 149, wherein said motor mechanically operates said restriction device.

151. An apparatus according to claim 137, further comprising a pump implanted in the patient for operating said restriction device.

152. An apparatus according to claim 151, wherein said pump hydraulically operates said restriction device.

153. An apparatus according to claim 137, wherein said restriction device is non-inflatable.

155. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

a source of energy,

a control device operable from outside the patient'"'"'s body for releasing energy from said source of energy, said released energy being used in connection with the operation of said restriction device,

a switch implantable in the patient for directly or indirectly switching said energy released from said source of energy, and

an energy transfer device for transferring wireless energy into an energy form suited for operating said switch.

157. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

a source of energy adapted to be implanted in the patient for supplying energy to be used in connection with the operation of said restriction device,

an energy transfer device for transferring wireless energy into an energy form suited for charging said source of energy,

a control device operable from outside the patient'"'"'s body to control said energy transfer device to charge said source of energy with transferred wireless energy,

wherein said control device comprises a wireless remote control transmitting at least one wireless control signal for controlling said restriction device and an internal control unit adapted to be implanted in the patient for receiving the wireless control signal, and

wherein said restriction device is non-inflatable.

158. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway in the colon or rectum or the prolongation thereof,

an implantable powered operation device for operating said restriction device,

a source of energy external to the patient'"'"'s body,

a control device operable from outside the patient'"'"'s body to control said external source of energy to release wireless energy,

an implantable energy transfer device adapted to transfer said wireless energy into storable energy, and

an implantable internal source of energy adapted to store said storable energy and power said operation device with said storable energy,

wherein said control device controls said restriction device to close the fecal passageway to prevent feces from passing therethrough and enlarge the fecal passageway to allow feces to readily pass therethrough, and

wherein said operation device comprises hydraulic means and at least one valve for controlling a fluid flow in said hydraulic means.

159. An apparatus according to claim 158, wherein said control device comprises a wireless remote control for controlling said valve.

160. An apparatus according to claim 158, wherein said restriction device comprises hydraulic means and said operation device comprises a reservoir forming a fluid chamber with a variable volume connected to said hydraulic means, and said operation device distributes fluid from said chamber to said hydraulic means by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

161. An apparatus according to claim 158, wherein said wireless energy is directly used for operation of said restriction device in a non-magnetic manner.

162. An apparatus according to claim 158, wherein said operation device comprises a hydraulic or pneumatic fluid motor, and said control device controls the fluid flow through said fluid motor.

163. An apparatus according to claim 158, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

164. An apparatus according to claim 163, wherein said operation device comprises a motor for driving said pump.

165. An apparatus according to claim 164, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

166. An apparatus according to claim 165, wherein said hydraulic means, pump and conduit are devoid of any non-return valve.

167. An apparatus according to claim 166, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

168. An apparatus according to claim 163, wherein said operation device comprises a motor for driving said pump.

169. An apparatus according to claim 168, wherein said operation device comprises a fluid conduit between ,said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

170. An apparatus according to claim 169, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

171. An apparatus according to claim 170, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

172. An apparatus according to claim 158, wherein said restriction device is non-inflatable.

173. An apparatus according to claim 158, wherein said control device releases magnetic energy.

174. An apparatus according to claim 158, wherein said control device releases kinetic energy.

175. An apparatus according to claim 158, wherein said control device releases energy from said external source of energy in a mechanical manner.

176. An apparatus according to claim 158, wherein said control device releases non-magnetic energy.

177. An apparatus according to claim 158, wherein said control device releases non-electromagnetic energy.

178. An apparatus according to claim 158, wherein said control device releases non-kinetic energy.

179. An apparatus according to claim 158, wherein said control device releases non-thermal energy.

180. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway,

an implantable powered operation device for operating said restriction device,

a source of energy external to the patient'"'"'s body,

a control device operable from outside the patient'"'"'s body to control said external source of energy to release non-magnetic wireless energy for use in the powering of said operation device,

an implantable energy transfer device for transferring said non-magnetic wireless energy into another form of energy usable by said operation device,

wherein said control device controls said restriction device to close the fecal passageway to prevent feces from passing therethrough and enlarge the fecal passageway to allow feces to readily pass therethrough.

181. An apparatus according to claim 180, wherein said control device comprises an internal control unit implantable in the patient for controlling said restriction device.

182. An apparatus according to claim 181, wherein said internal control unit comprises a microprocessor.

183. An apparatus according to claim 180, wherein said restriction device comprises hydraulic means and said operation device comprises a reservoir forming a fluid chamber with a variable volume connected to said hydraulic means, and said operation device distributes fluid from said chamber to said hydraulic means by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

184. An apparatus according to claim 180, wherein said non-magnetic wireless energy released from said external source of energy is directly, during energy transfer, used for operation of said restriction device.

185. An apparatus according to claim 184, wherein said wireless energy, directly or indirectly powers said operation device.

186. An apparatus according to claim 184, wherein said operation device comprises a motor.

187. An apparatus according to claim 186, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

188. An apparatus according to claim 186, wherein said motor comprises a linear motor.

189. An apparatus according to claim 186, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls the fluid flow through said fluid motor.

190. An apparatus according to claim 184, wherein said restriction device is operable by said operation device to perform a reversible function.

191. An apparatus according to claim 190, further comprising a reversing device implantable in the patient for reversing said function performed by said restriction device.

192. An apparatus according to claim 191, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

193. An apparatus according to claim 191, wherein said operation device comprises a motor, and said reversing device reverses said motor.

194. An apparatus according to claim 184, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

195. An apparatus according to claim 194, wherein said operation device comprises a motor for driving said pump.

196. An apparatus according to claim 195, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

197. An apparatus according to claim 196, wherein said hydraulic means, pump and conduit are devoid of any non-return valve.

198. An apparatus according to claim 197, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

199. An apparatus according to claim 180, further comprising a switch implantable in the patient for directly or indirectly switching the operation of said restriction device.

200. An apparatus according to claim 180, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.

201. An apparatus according to claim 200, wherein said control device controls said restriction device in response to signals from said sensor.

202. An apparatus according to claim 201, wherein said control device comprises an internal control unit implantable in the patient, said internal control unit controlling said restriction device in response to signals from said sensor.

203. An apparatus according to claim 200, wherein said control device comprises an external control unit that stores information on said physical parameter sensed by said sensor and is manually operated to control said restriction device based on said stored information.

204. An apparatus according to claim 180, wherein said restriction device is non-inflatable.

205. An apparatus according to claim 180, wherein said control device comprises a wireless remote control transmitting at least one wireless control signal for controlling said restriction device.

206. An apparatus according to claim 205, wherein said remote control is capable of sending information related to said restriction device from inside the patient'"'"'s body to the outside thereof.

207. An apparatus according to claim 205, wherein said 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.

208. An apparatus according to claim 205, wherein said control signal comprises an electric, magnetic or electric and magnetic field.

209. An apparatus according to claim 205, wherein said control signal is digital, analog or digital and analog.

210. An apparatus according to claim 180, wherein said control device releases energy from said external source of energy in a non-invasive manner.

211. An apparatus according to claim 180, wherein said control device releases non-thermal energy.

212. An apparatus according to claim 180, wherein said non-magnetic wireless energy comprises an electric field.

213. An apparatus according to claim 180, wherein said non-magnetic wireless energy is in the form of a digital, analog or digital and analog signal.

214. An apparatus according to claim 181, wherein said non-magnetic wireless energy comprises a wave signal, a sound signal or an ultrasound wave signal.

215. An anal incontinence disease treatment apparatus, comprising:

an operable restriction device adapted to be implanted in a patient to engage the colon or rectum or the prolongation thereof to form a restricted fecal passageway,

an implantable powered operation device for operating said restriction device,

a source of energy external to the patient'"'"'s body,

a control device operable from outside the patient'"'"'s body to control said external source of energy to release electromagnetic wireless energy for use in the powering of said operation device,

an implantable energy transfer device for transferring said electromagnetic wireless energy into another form of energy usable by said operation device,

wherein said control device controls said restriction device to close the fecal passageway to prevent feces from passing therethrough and enlarge the fecal passageway to allow feces to readily pass therethrough, and

wherein said control device comprises an internal control unit implantable in the patient for controlling said restriction device.

216. An apparatus according to claim 215, wherein said restriction device comprises hydraulic means and said operation device comprises a reservoir forming a fluid chamber with a variable volume connected to said hydraulic means, and said operation device distributes fluid from said chamber to said hydraulic means by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

217. An apparatus according to claim 215, wherein said operation device comprises a hydraulic or pneumatic fluid motor, and said control device controls the fluid flow through said fluid motor.

218. An apparatus according to claim 215, wherein said restriction device is operable by said operation device to perform a reversible function, and said apparatus further comprises a reversing device implantable in the patient for reversing said function performed by said restriction device, and

wherein said operation device comprises a motor, and said reversing device reverses said motor.

219. An apparatus according to claim 215, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

220. An apparatus according to claim 217, wherein said operation device comprises a motor for driving said pump.

221. An apparatus according to claim 220, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

222. An apparatus according to claim 221, wherein said hydraulic means, pump and conduit are devoid of any non-return valve.

223. An apparatus according to claim 222, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

224. An apparatus according to claim 215, wherein said restriction device is non-inflatable.

225. An apparatus according to claim 215, further comprising an implantable energy transfer device adapted to transfer said wireless energy into non-thermal energy.

226. An apparatus according to claim 215, wherein said electromagnetic wireless energy comprises an electromagnetic field.

227. An apparatus according to claim 215, wherein said electromagnetic wireless energy is in the form of a digital, analog or digital and analog signal.

228. A method of treating a human or animal having anal incontinence disease, comprising:

(a) surgically implanting in the human or animal an operable restriction device engaging the human'"'"'s or animal'"'"'s colon or rectum or the prolongation thereof to form a restricted fecal passageway,

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

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

(d) transferring said non-magnetic wireless energy into a different form of energy,

(e) using the different form of energy to operate the restriction device, and

(f) controlling the restriction device to restrict the fecal passageway to prevent feces from passing therethrough and enlarge the fecal passageway to allow feces to readily pass therethrough.