US2021290945A1PendingUtilityA1

Urinary incontinence treatment device and method for using the same

Assignee: INCONTROL MEDICAL LLCPriority: Sep 28, 2018Filed: Jun 7, 2021Published: Sep 23, 2021
Est. expirySep 28, 2038(~12.2 yrs left)· nominal 20-yr term from priority
A61N 1/36007A61M 25/1018A61N 1/0524A61N 1/0514A61N 1/0452A61N 1/36003
60
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Claims

Abstract

An apparatus for the treatment of urinary incontinence includes a probe, processing electronics, and a display. The probe includes a balloon, an electrode, and an internal cavity defined by the balloon. An electrode is coupled to an outer surface of the balloon, and is configured to transmit an electrical pulse to cause a contraction of a muscle in communication with the electrode. The internal cavity does not include a structural support element. The processing electronics are in communication with the electrode and configured to receive a signal indicative of a force of the contraction of the muscle and determine a value of the force of the contraction based on the signal. The display is in communication with the processing electronics and configured to receive the value of the force of the contraction from the processing electronics and present the value of the force of the contraction on the display.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An apparatus for treatment of urinary incontinence comprising:
 a probe comprising:
 a balloon comprising bellows configured for movement between an inflated state and a deflated state, wherein the bellows portion of the balloon is not supported by a structural support element when the balloon is in the inflated state; and 
 an electrode coupled to an outer surface of the balloon, the electrode configured to transmit an electrical pulse to cause a contraction of a muscle in physical communication with the electrode; 
   processing electronics in communication with the electrode, the processing electronics configured to receive a signal indicative of a force of the contraction of the muscle and determine a value of the force of the contraction based on the signal; and   a display in communication with the processing electronics, the display configured to receive the value of the force of the contraction from the processing electronics and present the value on the display.   
     
     
         2 . The apparatus of  claim 1 , wherein the signal indicative of the force of the contraction is received from the electrode. 
     
     
         3 . The apparatus of  claim 1 , further comprising a pressure sensor in communication with the processing electronics, wherein the signal indicative of the force of the contraction is received from the pressure sensor. 
     
     
         4 . The apparatus of  claim 3 , further comprising a tube barometrically connecting the pressure sensor and the internal cavity of the balloon. 
     
     
         5 . The apparatus of  claim 3 , wherein the pressure sensor is configured to determine a value of the pressure of the internal cavity and provide the value of the pressure to the processing electronics, and wherein the display is configured to receive the value of the pressure from the processing electronics and present the value of the pressure on the display. 
     
     
         6 . The apparatus of  claim 1 , wherein the bellows comprise at least two folds extending toward an interior of the balloon. 
     
     
         7 . The apparatus of  claim 1 , wherein the bellows and the electrode are further configured to cooperate to cause the balloon to inflate in a radially non-uniform manner. 
     
     
         8 . The apparatus of  claim 1 , wherein the electrode provides exterior longitudinal support of the balloon by being integrally formed within a material of the balloon such that the bellows and the electrode are configured to cooperate to maintain the structural integrity of the balloon. 
     
     
         9 . The apparatus of  claim 1 , further comprising a pump in communication with the balloon and configured to cause inflation of the balloon such that the electrode may contact a vaginal wall of a user. 
     
     
         10 . The apparatus of  claim 1 , wherein the processing electronics are further configured to inhibit the electrode from causing the contraction of the muscle in communication with the electrode until the balloon has been inflated to a predetermined pressure. 
     
     
         11 . The apparatus of  claim 1 , wherein the processing electronics are configured to cause inflation of the balloon. 
     
     
         12 . The apparatus of  claim 1 , wherein the processing electronics are configured to cause a current of between 10 milliamps and 50 milliamps. 
     
     
         13 . The apparatus of  claim 1 , wherein the electrode is a first electrode, and further comprising a second electrode coupled to the outer surface of the balloon, and wherein the processing electronics are configured to cause an electric potential difference between the first electrode and the second electrode. 
     
     
         14 . The apparatus of  claim 13 , wherein the electric potential difference is between 0 and 80 Volts. 
     
     
         15 . The apparatus of  claim 13 , wherein the electric potential difference is between 10 Volts and 50 Volts. 
     
     
         16 . The apparatus of  claim 13 , wherein the processing electronics are configured to variably control the electric potential difference. 
     
     
         17 . An apparatus for treatment of urinary incontinence comprising:
 a probe comprising:
 a balloon comprising bellows configured for movement between an inflated state and a deflated state, wherein the bellows portion of the balloon is not supported by a structural support element when the balloon is in the inflated state; 
 a first electrode coupled to a first outer surface of the balloon, the first electrode configured to transmit an electrical pulse to cause a contraction of a muscle in physical communication with the first electrode; and 
 a second electrode coupled to a second outer surface of the balloon, the second electrode configured to transmit an electrical pulse to cause a contraction of a muscle in physical communication with the second electrode; and 
   processing electronics in communication with the first electrode and the second electrode, the processing electronics configured to receive a signal indicative of at least one of i) a force of the contraction of the muscle in physical communication with the first electrode or ii) a force of the contraction of the muscle in physical communication with the second electrode, and determine a value of the force of the contraction based on the signal.   
     
     
         18 . The apparatus of  claim 17 , wherein the signal is received from at least one of the first electrode or the second electrode. 
     
     
         19 . The apparatus of  claim 17 , further comprising a pressure sensor in communication with the processing electronics, wherein the signal is received from the pressure sensor. 
     
     
         20 . A method for treating urinary incontinence comprising:
 providing a device comprising:
 a probe comprising:
 a balloon comprising bellows configured for movement between an inflated state and a deflated state, wherein the bellows portion of the balloon is not supported by a structural support element when the balloon is in the inflated state; 
 an electrode coupled to an outer surface of the balloon, the electrode configured to transmit an electrical pulse to cause a contraction of a muscle in physical communication with the electrode; and 
 an internal cavity defined by the balloon, the internal cavity not including a structural support element; 
 
 processing electronics in communication with the electrode, the processing electronics configured to receive a signal indicative of a force of the contraction of the muscle and determine a value of the force of the contraction based on the signal; and 
 a display in communication with the processing electronics, the display configured to display muscle strength data based on the value of the force of the contraction from the processing electronics; 
   causing, by the processing electronics, the balloon to inflate such that the electrode contacts the muscle for treatment;   causing, by the processing electronics, the electrode to transmit electrical pulses to the muscle; and   presenting, by the display, muscle strength data based on the value of the force of the contraction of the muscle in response to the electrical pulses.

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