# US 11,027,120 B2 · Urinary incontinence treatment device and method for using the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,120 B2 - Document ID: US11027120B2 - Status: Granted - Kind: B2 - Application number: 16/145,985 - Filed: 2018-09-28 - Published: 2020-04-02 - Granted: 2021-06-08 - Earliest claimed: 2018-09-28 - Assignees: Incontrol Medical, LLC - Applicants: Incontrol Medical, LLC - Inventors: Herschel Peddicord - Web page: https://patentgrep.com/patent/US11027120B2 ## CPC - A61N 1/0514: {Electrodes for the urinary tract} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61M 25/1018: {Balloon inflating or inflation-control devices} - A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]} - A61N 1/0524: {Vaginal electrodes} - A61N 1/36003: {of motor muscles, e.g. for walking assistance} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract An apparatus for the treatment of urinary incontinence includes a balloon configured for movement between an inflated state and a deflated state, and the balloon includes bellows. 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. A control device is configured to be operable by a user to cause the balloon to selectively move between the inflated state and the deflated state and to cause the electrode to transmit the electrical pulse. The bellows and the electrode are configured to cooperate to maintain the structural integrity of the balloon. The bellows and the electrode are further configured to cooperate to cause the balloon to inflate in a radially non-uniform manner. ## Claims ### Claim 1 An apparatus for the treatment of urinary incontinence comprising: a probe comprising: a balloon configured for movement between an inflated state and a deflated state, the balloon comprising bellows; 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 communication with the electrode; and an internal cavity defined by the balloon; and a control device configured to be operable by a user to cause the balloon to selectively move between the inflated state and the deflated state and to cause the electrode to transmit the electrical pulse; 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 without a structural support element being located within the internal cavity, the bellows and the electrode further configured to cooperate to cause the balloon to inflate in a radially non-uniform manner. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the bellows comprise at least two folds extending outward from an interior of the balloon. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the bellows comprise at least three folds extending toward an interior of the balloon. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the bellows comprise at least two folds extending outward from an interior of the balloon, and wherein the bellows comprise at least three folds extending toward the interior of the balloon. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the bellows are configured to maintain the balloon in a substantially oval shape when the balloon is in a deflated state. ### Claim 6 (depends on 1) The apparatus of claim 1 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. ### Claim 7 (depends on 1) The apparatus of claim 1 comprising processing electronics configured to inhibit the electrode from causing a contraction of the muscle in communication with the electrode until the balloon has been inflated to a predetermined pressure. ### Claim 8 (depends on 1) The apparatus of claim 1 comprising processing electronics configured to cause an indication in response to a determination that a pressure inside the balloon has reached a predetermined value. ### Claim 9 (depends on 1) The apparatus of claim 1 comprising processing electronics configured to cause an indication in response to a determination that the balloon has been inflated to a pressure equal to or greater than a predetermined value. ### Claim 10 (depends on 1) The apparatus of claim 1 comprising processing electronics configured to cause inflation of the balloon. ### Claim 11 (depends on 1) The apparatus of claim 1 comprising processing electronics configured to cause a current of between 10 milliamps and 50 milliamps. ### Claim 12 (depends on 1) The apparatus of claim 1, wherein the electrode is a first electrode, and further comprising a second electrode coupled to an outer surface of the balloon and processing electronics configured to cause an electric potential difference between the first electrode and the second electrode. ### Claim 13 (depends on 12) The apparatus of claim 12, wherein the electric potential difference is between 0 and 80 Volts. ### Claim 14 (depends on 12) The apparatus of claim 12, wherein the electric potential difference is between 10 Volts and 50 Volts. ### Claim 15 (depends on 12) The apparatus of claim 12, wherein the processing electronics are configured to variably control the electric potential difference. ### Claim 16 (depends on 1) The apparatus of claim 1, wherein the material of the balloon between the electrode and the interior of the balloon is a first thickness, the material of the balloon of the bellows is a second thickness, and the first thickness is greater than the first second thickness. ### Claim 17 (depends on 1) The apparatus of claim 1, wherein the electrode provides exterior longitudinal support of the balloon by being positioned along a majority of a length of the balloon. ### Claim 18 An apparatus for the treatment of urinary incontinence comprising: a probe comprising: a balloon configured for movement between an inflated state and a deflated state, the balloon comprising bellows; 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 communication with the first electrode; 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 communication with the second electrode; and an internal cavity defined by the balloon; and a control device configured to cause the balloon to inflate such that the first electrode and the second electrode contact the muscle, and to cause the first electrode and the second electrode to transmit electrical pulses to the muscle; wherein the balloon is substantially hollow, and wherein the electrode provides exterior longitudinal support of the balloon by being integrally formed within a material of the balloon such that the bellows, the first electrode, and the second electrode are configured to cooperate to maintain the structural integrity of the balloon without a structural support element being located within the internal cavity. ### Claim 19 (depends on 18) The apparatus of claim 18, wherein the bellows comprise at least two folds extending outward from an interior of the balloon, and wherein the bellows comprise at least three folds extending toward the interior of the balloon. ### Claim 20 (depends on 18) The apparatus of claim 18, wherein the bellows are configured to maintain the balloon in a substantially oval shape when the balloon is in a deflated state. ### Claim 21 A method for treating urinary incontinence comprising: providing a device comprising a probe, the probe comprising: a balloon configured for movement between an inflated state and a deflated state, the balloon comprising bellows; 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 communication with the first electrode; 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 the muscle in communication with the second electrode; and an internal cavity defined by the balloon; causing, by a control device, the balloon to inflate such that the first electrode and the second electrode contact the muscle; and causing, by the control device, the first electrode and the second electrode to transmit electrical pulses to the muscle; wherein the balloon is substantially hollow, and wherein the electrode provides exterior longitudinal support of the balloon by being integrally formed within a material of the balloon such that the bellows, the first electrode, and the second electrode are configured to cooperate to maintain the structural integrity of the balloon without a structural support element being located within the internal cavity.