Method and apparatus for treating incontinence
First Claim
Patent Images
1. An implantable sphincter stimulator configured for operatively providing electrical stimulation to a surgically implanted innervated smooth muscle sphincter disposed about a urethra so as to control the flow of urine therethrough, the stimulator including:
- a stimulus generating unit in electrical communication with a receiver, the stimulus generating unit operatively configured to provide a first predetermined electrical stimulation signal adapted to contract said sphincter, and a second predetermined signal adapted to allow said sphincter to relax, one of said predetermined signals being selected in response to a control signal received at the receiver from a remote controller.
1 Assignment
0 Petitions
Accused Products
Abstract
An improved method, system and arrangement for treatment of urinary incontinence is disclosed, in which a portion of innervated smooth muscle (2) is transplanted and disposed around the urethra to provide a urethral sphincter (2). Electrical stimulation, by an implanted stimulator (1), maintains continuous tone in the sphincter. A remote controller (7) permits the sphincter (2) to be allowed to relax, and hence permit urine to flow out of the bladder.
123 Citations
178 Claims
-
1. An implantable sphincter stimulator configured for operatively providing electrical stimulation to a surgically implanted innervated smooth muscle sphincter disposed about a urethra so as to control the flow of urine therethrough, the stimulator including:
a stimulus generating unit in electrical communication with a receiver, the stimulus generating unit operatively configured to provide a first predetermined electrical stimulation signal adapted to contract said sphincter, and a second predetermined signal adapted to allow said sphincter to relax, one of said predetermined signals being selected in response to a control signal received at the receiver from a remote controller. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
-
25. A system for use in treating urinary incontinence in a person, the system including:
-
a portion of innervated smooth muscle tissue configured to define a sphincter and implanted substantially circumferentially about the urethra of the person;
an implanted sphincter stimulator arranged so as to allow electrical stimuli to be applied to the sphincter; and
a non-implanted controller in communication with the sphincter stimulator for selectively triggering the generation of predetermined electrical stimulation signals to respectively contract the sphincter or allow the sphincter to relax. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80)
a transmitter;
means for generating a predetermined control signal at the transmitter;
a power source; and
actuation means for selectively generating the control signal such that on receipt of the signal, the sphincter stimulator provides the stimulation signal at its output in order to contract the sphincter or allow it to relax.
-
-
75. A system according to claim 25 wherein the controller includes a receiver for receiving a stimulator information telemetry signal from the sphincter stimulator.
-
76. A system according to claim 74 wherein the control signal is transmitted optically, magnetically, by radio waves, or by microwaves.
-
77. A system according to claim 74 including a remote sphincter stimulator programming unit for selectively programming the sphincter stimulator to provide a predetermined output in response to the control signal.
-
78. A system according to claim 77 wherein one or more of the stimulation signal current, shape, frequency and width is variable in response to a calibration signal provided by the programming unit.
-
79. A system according to claim 77 wherein the programming unit includes a transceiver for providing the programming signal to the stimulator.
-
80. A system according to claim 77 wherein the programming unit is the controller.
- 81. A method of using an implantable sphincter stimulator for treating urinary incontinence, the method including the steps of disposing a smooth muscle sphincter about a urethra, providing an implanted stimulator unit connected to electrodes, arranging the electrodes so that the electrodes are adapted to stimulate the neural structures of said sphincter, and providing a predetermined stimulation signal at the sphincter stimulator output to either contract the sphincter or allow it to relax in response to a control signal provided from an externally disposed controller.
-
97. A method of treating urinary incontinence including the steps of:
-
disposing an implanted innervated smooth muscle sphincter around a urethra;
locating a plurality of electrodes in predetermined locations in the sphincter in electrically connecting the electrodes with an implanted sphincter stimulator; and
selectively actuating the sphincter stimulator to provide a predetermined stimulation signal to either contract the urethra or allow it to relax in response to a remotely generated control signal. - View Dependent Claims (98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121)
-
-
122. A method of surgically implanting a sphincter stimulator system for treating urinary incontinence including the steps of:
-
implanting a smooth muscle sphincter about the urethra in a person;
implanting a stimulator proximal to the sphincter; and
implanting a plurality of electrodes into the sphincter at predetermined locations and electrically connecting the stimulator therewith. - View Dependent Claims (123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178)
a portion of inervated smooth muscle tissue configured to define a sphincter and implanted substantially circumferentially about the urethra of the person;
an implanted sphincter stimulator arranged so as to allow electrical stimuli to be applied to the sphincter; and
a non-implanted controller in communication with the sphincter stimulator for selectively triggering the generation of predetermined electrical stimulation signals to respectively contract the sphincter or allow the sphincter to relax.
-
-
124. A method according to claim 123 wherein the muscle is in the form of a strip.
-
125. A method according to claim 124 wherein the strip is generally rectangular.
-
126. A method according to claim 123 wherein the muscle is disposed substantially fully around the urethra in a generally cylindrical arrangement.
-
127. A method according to claim 126 wherein the long axes of the muscle cells are substantially circumferentially aligned.
-
128. A method according to claim 123 wherein the smooth muscle is taken from the terminal ileum and transplanted about the urethra as a segment devoid of mucosa and having its circulation intact.
-
129. A method according to claim 128 wherein the muscle is in the form of a strip.
-
130. A method according to claim 129 wherein the strip is generally rectangular.
-
131. A method according to claim 130 wherein the strip has dimensions in the range from 4.5 cm to 7.5 cm by 1.25 cm to 2.25 cm.
-
132. A method according to claim 123 wherein the muscle is venous smooth muscle.
-
133. A method according to claim 132 wherein the muscle is in the form of a strip.
-
134. A method according to claim 133 wherein the strip is generally rectangular.
-
135. A method according to claim 134 wherein the strip has dimensions in the range from 4.5 cm to 7.5 cm by 1.25 cm to 2.25 cm.
-
136. A method according to claim 123 wherein the muscle is anococcygeus smooth muscle.
-
137. A method according to claim 136 wherein the muscle is in the form of a strip.
-
138. A method according to claim 137 wherein the strip is generally rectangular.
-
139. A method according to claim 137 wherein the strip has dimensions in the range from 4.5 cm to 7.5 cm by 1.25 cm to 2.25 cm.
-
140. A method according to claim 123 wherein the muscle is smooth muscle from the bladder.
-
141. A method according to claim 140 wherein the muscle is in the form of a strip.
-
142. A method according to claim 141 wherein the strip is generally rectangular.
-
143. A method according to claim 142 wherein the strip has dimensions in the range from 4.5 cm to 7.5 cm by 1.25 cm to 2.25 cm.
-
144. A method according to claim 123 wherein the muscle is the dartos muscle taken from the scrotum or labia.
-
145. A method according to claim 144 wherein the muscle is in the form of a strip.
-
146. A method according to claim 145 wherein the strip is generally rectangular.
-
147. A method according to claim 146 wherein the muscle strip has the dimensions of 6 cm by 1.5 to 2 cm.
-
148. A method according to claim 123 wherein the sphincter stimulator includes a stimulous generating unit in electrical communication with a receiver, the stimulus generating unit operatively configured to provide a first predetermined electrical stimulation signal adapted to contract said sphincter, and a second predetermined signal adapted to allow said sphincter to relax, one of said predetermined signals being selected in response to a control signal received at the receiver from a remote controller.
-
149. A method according to claim 148 wherein the stimulation signal is pulsatile.
-
150. A method according to claim 149 wherein the stimulation signal is generally rectangular and symmetrical biphasic.
-
151. A method according to claim 149 wherein the stimulation signal current is less than or equal to 30 mA.
-
152. A method according to claim 149 wherein the stimulation signal pulse frequency is in the range of 0.25 to 2.5 Hz.
-
153. A method according to claim 149 wherein the stimulation signal pulse has a width in the range of 0.05 to 0.02 milliseconds.
-
154. A method according to claim 148 wherein the stimulation signal is such as to provide a continuous tone in said sphincter.
-
155. A method according to claim 154 wherein the stimulation signal is pulsatile.
-
156. A method according to claim 155 wherein the stimulation signal is generally rectangular and symmetrical biphasic.
-
157. A method according to claim 155 wherein the stimulation signal current is less than or equal to 30 mA.
-
158. A method according to claim 155 wherein the stimulation signal pulse frequency is in the range of 0.25 to 2.5 Hz.
-
159. A method according to claim 155 wherein the stimulation signal pulse has a width in the range of 0.05 to 0.02 milliseconds.
-
160. A method according to claim 148 wherein the control signal is communicated optically, magnetically, by RF, or by microwave.
-
161. A method according to claim 148 wherein the stimulous generating unit includes a demodulator responsive to the received signal for providing a modulated signal to a stimulus encoder which in turn provides a signal to a stimulus driver which provides the stimulation signal at selected ones of the stimulator outputs.
-
162. A method according to claim 148 wherein, after the sphincter has relaxed, the stimulator includes means to supply the first stimulation signal at a selected one of its outputs to contract the sphincter when a predetermined signal to contract the sphincter is not received by the receiver for a predetermined period.
-
163. A method according to claim 148 wherein said system includes a transmitter for transmitting sphincter stimulator telemetry information indicative of one or more parameters of the stimulator for detection remotely.
-
164. A method according to claim 163 wherein the telemetry information is transmitted by the same communications means as the control signal.
-
165. A method according to claim 163 wherein the parameters include one or more of the stimulation signal frequency, current, width and/or shape, or received signal strength or battery status.
-
166. A method according to claim 163 wherein the receiver is configured to accept a remotely generated sphincter stimulator calibration signal and in response, a signal processing unit selectively varies one or more of the output properties of the sphincter stimulator.
-
167. A method according to claim 166 wherein the calibration signal is transmitted in response to received sphincter telemetry information.
-
168. A method according to claim 148 wherein the stimulation generating unit is operatively connected to the sphincter by one or more electrical leads, each having one or more electrodes.
-
169. A method according to claim 168 wherein the one or more leads include three electrodes disposed in an epimysal configuration about the sphincter.
-
170. A method according to claim 168 wherein the one or more leads include three electrodes disposed in a cuff configuration about the sphincter.
-
171. A method according to claim 168 wherein the one or more leads include three electrodes disposed in a tripolar configuration about the sphincter.
-
172. A method according to claim 123 wherein the controller includes:
-
a transmitter;
means for generating a predetermined control signal at the transmitter;
a power source; and
actuation means for selectively generating the control signal such that on receipt of the signal, the sphincter stimulator provides the stimulation signal at its output in order to contract the sphincter or allow it to relax.
-
-
173. A method according to claim 123 wherein the controller includes a receiver for receiving a stimulator information telemetry signal from the sphincter stimulator.
-
174. A method according to claim 172 wherein control signal is transmitted optically, magnetically, by radio waves, or by microwaves.
-
175. A method according to claim 172 wherein the system includes a remote sphincter stimulator programming unit for selectively programming the sphincter stimulator to provide a predetermined output in response to the control signal.
-
176. A method according to claim 175 wherein one or more of the stimulation signal current, shape, frequency and width is variable in response to a calibration signal provided by the programming unit.
-
177. A method according to claim 175 wherein the programming unit includes a transceiver for providing the programming signal to the stimulator.
-
178. A method according to claim 175 wherein the programming unit is the controller.
Specification