Mechanical anal incontinence

• US 20070073099A1
• Filed: 06/28/2006
• Published: 03/29/2007
• Est. Priority Date: 02/11/2000
• Status: Active Grant

• Current Assignee: Obtech Medical AG
• Original Assignee: Obtech Medical AG
• Inventors: Forsell, Peter
• Granted Patent: US 8,734,318 B2
• Time in Patent Office: Days
• US Class Current: 600/31
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• 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 comprises an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The device engages a portion of the colon or rectum of the patient to restrict the fecal passageway. An adjustment device mechanically adjusts the rest* on device to restrict or release the fecal passageway, i.e. to normally close the fecal passageway and open the fecal passageway when the patient wants to relieve himself or herself.

Claims

1-93. -93. (canceled)

94. An anal incontinence treatment apparatus, comprising:

an adjustable non-inflatable restriction device adapted to be implanted in a patient, who suffers from anal incontinence, to constrict a portion of the colon or rectum or the prolongation thereof to restrict the fecal passageway therein,

an operable adjustment device adapted to be implanted in the patient to adjust said restriction device,

a powered operation device adapted to be implanted in the patient to operate said adjustment device to adjust said restriction device to restrict the fecal passageway to prevent feces from passing there through and enlarge the fecal passageway to allow feces to readily pass there through,

an energizer unit for supplying energy for the power of said operation device and operation of said adjustment device, wherein

said adjustment device comprises a servo system to save the use of force when adjusting said adjustment device.

95. An anal incontinence treatment apparatus according to claim 94, wherein said adjustment device comprises a mechanically operable adjustment device adapted to mechanically adjust said restriction device

96. An anal incontinence treatment apparatus according to claim 94, wherein said adjustment device comprises a hydraulically operable adjustment device adapted to mechanically adjust said restriction device

97. An anal incontinence treatment apparatus according to claim 94, wherein said adjustment device comprises a hydraulically operable adjustment device adapted to hydraulically adjust said restriction device

98. An anal incontinence treatment apparatus according to claim 94, wherein said adjustment device comprises a mechanically operable adjustment device adapted to hydraulically adjust said restriction device

99. The apparatus according to claim 94;

wherein said operation device comprises a motor capable of performing a reversible function and wherein said restriction device is capable of performing a reversible function.

100. The apparatus according to claim 99, comprising a reversing device adapted to be implanted in the patient for reversing the motor.

101. The apparatus according to claim 94, comprising a gear transmission adapted to be implanted in the patient, said gear transmission being operatively connecting said operation device and adjustment device.

102. The apparatus according to claim 94 further comprising a wireless remote control for controlling said adjustment device.

103. The apparatus according to claim 102, wherein said remote control comprises a separate signal transmitter and/or receiver and a signal receiver and/or transmitter adapted to be implanted in the patient.

104. The apparatus according to claim 102, wherein said signal receiver comprises a control unit for controlling said adjustment device in response to a control signal received from said signal transmitter.

105. The apparatus according to claim 104, wherein said energizer unit is adapted to be implanted in the patient for providing energy to energy consuming components of said operation device.

106. The apparatus according to claim 104, wherein said operation device comprises a motor adapted to be implanted in the patient for operating said adjustment device.

107. The apparatus according to claim 106, wherein said control unit controls the powering of said motor with energy provided by said energizer unit in response to a control signal received from said signal transmitter.

108. The apparatus according to claim 107, wherein said motor comprises an electric motor.

109. The apparatus according to claim 104, comprising wireless energy transmitted by said signal transmitter transmitting said control signal, and wherein said energizer unit transfers energy from said control signal, as the latter is transmitted to said signal receiver, into electric energy.

110. The apparatus according to claim 94, further comprising

(i) a wireless energy transmitter capable of transmitting wireless energy;

(ii) an electric motor adapted to be implanted in the patient for operating said adjustment device; and

(iii) an implanted control unit for controlling said motor, wherein said energizer unit, transferring said wireless energy into electrical energy, comprising a rechargeable electric power supply for storing said electric energy and said control unit controls the powering of said electric motor with energy from said rechargeable electric power supply in response to a control signal received from said signal transmitter.

111. The apparatus according to claim 110, comprising a wireless remote control sending a control signal from outside the human body, controlling the implanted control unit and the powering of said motor

112. The apparatus according to claim 105, wherein said energizer unit comprises a battery, an electrically operable switch for connecting said battery to said signal receiver in an “

on”

mode when said switch is powered and to keep said battery disconnected from said signal receiver means in a “

standby”

mode when said switch is unpowered, and a rechargeable electric power supply for powering said switch.

113. The apparatus according to claim 112, wherein said control unit controls the powering of said electric motor with energy from said battery in response to a control signal received from said signal transmitter, when said switch is in its “

on”

mode.

114. The apparatus according to claim 105, further comprising an external energy transmitter for transmitting wireless energy, wherein said energizer unit comprises a battery and an operable switch for connecting said battery to said signal receiver in an “

on”

mode when said switch is powered and to keep said battery disconnected from said signal receiver in a “

standby”

mode when said switch is unpowered, said external energy transmitter for powering said switch.

115. The apparatus according to claim 114, wherein said energy transmitter directly powers said switch with said wireless energy to switch into said “

on”

mode.

116. The apparatus according to claim 94, further comprising an external energy transmitter for transmitting wireless energy, wherein said energizer unit transfers said energy from said wireless energy into a direct or alternating current.

117. The apparatus according to claim 94, further comprising an external energy transmitter for transmitting wireless energy, wherein said energizer unit comprises a battery or accumulator adapted to be implanted in the patient for storing said transferred wireless energy and for providing energy to energy consuming components of said operation device.

118. The apparatus according to claim 103, wherein said signal transmitter and signal receiver transmit and receive a signal in the form of digital pulses.

119. The apparatus according to claim 118, wherein said digital pulses comprise an electric or magnetic field.

120. The apparatus according to claim 103, wherein said signal transmitter and signal receiver transmit and receive a wave signal.

121. The apparatus according to claim 120, wherein said wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal.

122. The apparatus according to claim 102, wherein said remote control is capable of obtaining information related to the pressure against the restriction device, directly or indirectly, and of commanding said adjustment device to directly or indirectly adjust said restriction device in response to obtained information.

123. The apparatus according to claim 104, wherein said control unit is an implanted control unit, capable of obtaining information related to the pressure against the restriction device, directly or indirectly, and of commanding said adjustment device to directly or indirectly adjust said restriction device in response to obtained information.

124. The apparatus according to claim 94, wherein said adjustment device adjusts said restriction device in a non-manual manner.

125. The apparatus according to claim 94, further comprising an external energy transmitter for transmitting wireless energy, wherein said energizer unit comprises an energy transfer device adapted to be implanted in the patient for transferring wireless energy directly or indirectly into kinetic energy for operation of said restriction device.

126. The apparatus according to claim 125, wherein said energy transfer device supplies energy to energy consuming components of the apparatus adapted to be implanted in the patient.

127. The apparatus according to claim 126, wherein energy directly, during energy transfer device, directly during energy transfer, powers said energy consuming components of the apparatus adapted to be implanted in the patient.

128. The apparatus according to claim 127, further comprising a motor adapted to be implanted in the patient for operating said adjustment device, wherein said energy transfer device directly, during energy transfer, powers said motor with transferred energy.

129. The apparatus according to claim 127, wherein said wireless energy transferred by said energy transfer device comprises a wave signal.

130. The apparatus according to claim 127, wherein said energy transferred by said energy transfer device comprises an electric or magnetic field.

131. The apparatus according to claim 129, wherein said wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal.

132. The apparatus according to claim 94, wherein said restriction device comprises at least one elongated restriction member and forming means adapted to form said restriction member into an at least substantially closed loop around the portion of the colon or rectum or the prolongation thereof, said loop defining a restriction opening, whereby said adjustment device adjusts said restriction member in said loop to change the size of said restriction opening.

133. The apparatus according to claim 132, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is changed.

134. The apparatus according to claim 132, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of the restriction member is unchanged.

135. The apparatus according to claim 132, wherein said forming means comprises a spring material forming said elongated restriction member into said loop, such that said restriction opening has a predetermined size, and said adjustment device adjusts said restriction member against the spring action of said spring material.

136. The apparatus according to claim 135, wherein said spring material is integrated in said restriction member.

137. The apparatus according to claim 132, wherein said forming means form said restriction member into a loop having a predetermined size.

138. The apparatus according to claim 132, wherein said elongated restriction member is flexible, and said adjustment device pulls a first portion of said flexible restriction member from a second portion of said flexible restriction member opposite said first portion in said loop to squeeze the portion of the colon or rectum or the prolongation thereof between two opposite lengths of said elongated flexible restriction member to restrict the fecal passageway and moves said first portion toward said second portion of said restriction member to release the portion of the colon or rectum or the prolongation thereof from said flexible restriction member to enlarge the fecal passageway.

139. The apparatus according to claim 132, wherein said restriction device comprises several elongated restriction members adapted to extend around the colon or rectum or the prolongation thereof.

140. The apparatus according to claim 132, wherein said adjustment device adjusts the longitudinal extension of said elongated restriction member.

141. The apparatus according to claim 140, wherein said restriction member comprises a main portion and two elongated end portions, and said adjustment device establishes a longitudinal relative displacement between said end portions of said restriction member, such that the size of said restriction opening is adjusted.

142. The apparatus according to claim 141, wherein said adjustment device comprises a movement transferring member in engagement with at least one of said end portions of said restriction member and operable to displace said one end portion relative to said other end portion of said restriction member.

143. The apparatus according to claim 142, further comprising a motor, which is fixed relative to said main portion of said restriction member and has a rotating drive shaft operatively connected to said movement transferring member.

144. The apparatus according to claim 143, wherein said motor is positioned relative to said elongated restriction member such that said drive shaft extends in parallel with a chord in said loop of the restriction member.

145. The apparatus according to claim 140, wherein said elongated restriction member is longitudinally resilient and said adjustment device comprises a contraction device, which longitudinally contracts said resilient restriction member.

146. The apparatus according to claim 145, wherein said elongated restriction member comprises a substantially nonresilient main portion and an end portion forming an elongated helical spring, which is contractable by said contraction device.

147. The apparatus according to claim 146, wherein said contraction device comprises an elongated flexible pulling member connected to said main portion of said restriction member and extending through said helical spring to contract said helical spring against an arresting member, which is fixed relative to said main portion of said restriction member.

148. The apparatus according to claim 140, wherein said restriction member comprises an elongated helical spring having a free end, and a body to which said spring is nonrotatably secured at its opposite end, said adjustment device rotates said helical spring in one direction to enlarge the coils of said helical spring to longitudinally contract said elongated helical spring and to rotate said helical spring in the opposite direction to reduce the size of the coils of said helical spring to longitudinally extend said helical spring.

149. The apparatus according to claim 148, wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a drive shaft having two opposite end portions connected to said helical springs, respectively, at their free ends, said helical coils forming left and right hand helices, respectively.

150. The apparatus according to claim 149, wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a gearing having an input shaft and two opposite aligned output shafts connected to said helical springs, respectively, at their free ends, said input shaft being connected to said output shafts such that said output shafts rotate in opposite directions upon rotation of said input shaft, said helical coils forming the same helices.

151. The apparatus according to claim 132, wherein said restriction member forms a radially innermost at least partly circumferential confinement surface of said restriction member, and said adjustment device mechanically adjusts said restriction member such that at least a portion of said confinement surface is substantially radially displaced in said loop.

152. The apparatus according to claim 151, wherein said adjustment device comprises an elongated voltage responsive element forming part of said confinement surface and capable of bending into a bow in response to a voltage applied across said element, the radius of curvature of said bow being adjustable by changing the level of said voltage.

153. The apparatus according to claim 151, wherein said restriction member comprises an elastic annular element forming said confinement surface, and said adjustment device changes the diameter of said elastic annular element.

154. The apparatus according to claim 151, wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises an elongated helical spring extending internally along said outer annular element and contacting the latter, said helical spring forming part of said circumferential confinement surface and having a free end, and a body to which said helical spring is nonrotatably secured at its opposite end, and said adjustment device rotates said helical spring in one direction to enlarge the coils of said helical spring to contract said circumferential confinement surface and rotates said helical spring in the opposite direction to reduce the size of the coils of said helical spring to expand said circumferential confinement surface.

155. The apparatus according to claim 151, wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises a first and a second elongated helical spring extending internally along said outer annular element and contacting the latter, said helical springs forming part of said circumferential confinement surface, said first and said second spring, respectively, having a free end, and a body to which said first and said second spring, respectively, is nonrotatably secured at its opposite end, and said adjustment device rotates said first and said second spring, respectively, in one direction to enlarge the coils of said spring to contract said circumferential confinement surface and rotates said first and said second spring, respectively, in the opposite direction to reduce the size of the coils of said spring to expand said circumferential confinement surface.

156. The apparatus according to claim 132, wherein said restriction member comprises at least two separate elements, at least one of which is pivoted such that it may turn in a plane in which said loop of said restriction member extends, and said adjustment device turns said pivoted element to change the size of said restriction opening.

157. The apparatus according to claim 132, wherein said elongated restriction member is elastic and varies in thickness as seen in a cross-section there through, and said adjustment device turns said restriction member around the longitudinal extension thereof.

158. The apparatus according to claim 94, wherein said restriction device is adapted to be implanted in the base of the rectum or the prolongation thereof.

159. The apparatus according to claim 94, wherein said restriction device comprises at least two elements adapted to be positioned on different sides of the portion of the colon or rectum or the prolongation thereof, and said adjustment device moves said elements toward each other to squeeze the portion of the colon or rectum or the prolongation thereof between said elements to restrict the fecal passageway.

160. The apparatus according to claim 94, wherein said restriction device comprises one element adapted to be positioned on one side of the portion of the colon or rectum or the prolongation thereof, and said adjustment device is adapted to squeeze the portion of the colon or rectum or the prolongation thereof between said element and the human bone or tissue of the patient to restrict the fecal passageway.

161. The apparatus according to claim 94, wherein said restriction device comprises at least two frame elements, which are foldable towards each other by said adjustment device.

162. The apparatus according to claim 161, wherein said foldable frame elements comprise two substantially or partly semi-circular frame elements, which are hinged together such that said semi-circular elements are swingable relative to each other from a fully open state in which they substantially or partly form a circle to a fully folded state in which they substantially form a semi-circle.

163. The apparatus according to claim 94, wherein said servo system comprises a hydraulic means adapted to be implanted in the patient, said hydraulic means operating said adjustment device.

164. The apparatus according to claim 163, further comprising an reservoir containing a predetermined amount of fluid adapted to be implanted in the patient for supplying said hydraulic means with fluid.

165. The apparatus according to claim 164, wherein said reservoir defines a chamber for said predetermined amount of fluid and said hydraulic means changes the size of said chamber.

166. The apparatus according to claim 165, wherein said hydraulic means comprises an activatable pump for pumping fluid between said reservoir and said adjustment device.

167. The apparatus according to claim 165, wherein said hydraulic means comprises first and second wall portions of said reservoir, and said servo means provides relative displacement between said first and second wall portions of said reservoir.

168. The apparatus according to claim 94, wherein said servo system comprises an electric control means, a magnetic means, a mechanical means or a manual manipulation means.

169. The apparatus according to claim 94, wherein said restriction device comprises at least two spaced apart elements rotating in opposite directions and adapted to engage the colon or rectum or the prolongation thereof, and said adjustment device is adapted to squeeze the portion of the colon or rectum or the prolongation thereof between said elements when they are rotated to decrease the fecal passageway.

170. The apparatus according to claim 94, wherein said restriction device comprises at least two articulated clamping elements adapted to be positioned on different sides of the portion of the colon or rectum or the prolongation thereof, and said adjustment device is adapted to move said clamping elements towards each other to clamp the portion of the colon or rectum or the prolongation thereof between said clamping elements to restrict the fecal passageway, and to move said clamping elements away from each other to release the portion of the colon or rectum or the prolongation thereof to enlarge the fecal passageway.

171. The apparatus according to claim 94, wherein said restriction device bends the portion of the colon or rectum or the prolongation thereof.

172. The apparatus according to claim 171, wherein said restriction device comprises at least two bending members adapted to be positioned on opposite or different sides of the portion of the colon or rectum or the prolongation thereof, and said adjustment device is adapted to move said bending members against the portion of the colon or rectum or the prolongation thereof in two opposite spaced apart directions to bend the portion of the colon or rectum or the prolongation thereof to restrict the fecal passageway, and to move said bending members away from each other to release the portion of the colon or rectum or the prolongation thereof to enlarge the fecal passageway.

173. The apparatus according to claim 172, wherein said bending members comprise rollers.

174. The apparatus according to claim 94, wherein said restriction device rotates the portion of the colon or rectum or the prolongation thereof.

175. The apparatus according to claim 94, wherein said restriction device is adapted to control the cross-sectional area of the fecal passageway.

176. The apparatus according to claim 175, wherein said restriction device is operable to constrict the portion of the colon or rectum or the prolongation thereof to close the fecal passageway.

177. The apparatus according to claim 176, wherein said restriction device is adapted to steplessly control the cross-sectional area of the fecal passageway.

178. The apparatus according to claim 94, further comprising a pressure sensor adapted to be implanted in the patient for directly or indirectly sensing the pressure against the restriction device.

179. The apparatus according to claim 178, wherein said restriction device is controlled in response to signals from said pressure sensor.

180. The apparatus according to claim 94, wherein said operation device or other energy consuming components of the apparatus are energized with wirelessly transmitted energy from outside the patient'"'"'s body.

181. The apparatus according to claim 94, wherein said energizer unit comprises an accumulator or battery adapted to be implanted in the patient and means for controlling said accumulator or battery from outside the patient'"'"'s body to supply energy to said operation device or other energy consuming components of the apparatus adapted to be implanted in the patient.

182. The apparatus according to claim 181, further comprising an external energy transmitter for transmitting wireless energy, wherein said accumulator or battery is charged with said wirelessly transmitted energy from outside the patient'"'"'s body, and means for controlling said accumulator or battery from outside the patient'"'"'s body to supply energy to said operation device or other energy consuming components of the apparatus adapted to be implanted in the patient.

183. The apparatus according to claim 181, comprising an energizer unit capable of transferring said wireless energy into electric energy, wherein said wireless energy comprises a wave signal.

184. The apparatus according to claim 181, comprising an energizer unit capable of transferring said wireless energy into electric energy, wherein said wireless energy comprises an electric or magnetic field.

185. The apparatus according to claim 183, wherein said wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal.