# US 11,439,819 B2 · Urethral catheters and methods for facilitated introduction into the urinary tract > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,819 B2 - Document ID: US11439819B2 - Status: Granted - Kind: B2 - Application number: 16/743,361 - Filed: 2020-01-15 - Published: 2020-06-18 - Granted: 2022-09-13 - Earliest claimed: 2016-03-02 - Assignees: InCube Labs, LLC - Applicants: InCube Labs, LLC - Inventors: Mir Imran - Web page: https://patentgrep.com/patent/US11439819B2 ## CPC - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61M 25/0108: {using radio-opaque or ultrasound markers} - A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61N 1/0514: {Electrodes for the urinary tract} - A61B 2090/064: {for measuring force, pressure or mechanical tension} - A61B 2090/376: {using X-rays, e.g. fluoroscopy} - A61B 2090/378: {using ultrasound} - A61M 3/0279: {Cannula; Nozzles; Tips; their connection means} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 2210/1096: Male - A61N 1/36139: {with automatic adjustment} - A61N 5/0601: {Apparatus for use inside the body} - A61N 5/0622: {Optical stimulation for exciting neural tissue} - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Embodiments of the invention provide apparatus, systems and methods for facilitating introduction of a urinary drainage catheter (UDC) into the urinary tract (UT). One embodiment provides a UDC including electrodes for delivering high frequency current to a patient's pudendal nerves to relax the urinary sphincter (US) before passing the UDC therethrough so as reduce the resistance force on the UDC and discomfort to the patient. The electrodes can comprise at least one pair of bipolar electrodes and may be flexible so as to bend and flex within the urethra. The UDC includes one or more lumens including a drainage lumen and an inflation lumen for inflating an anchoring device on the UDC. The UDC can include a pressure sensor to assess relaxation of the US. The UDC may include a second set of electrodes and irrigation lumen for relaxing the US and flushing the urethra with the UDC in place. ## Claims ### Claim 1 A urinary drainage catheter comprising: an elongated flexible catheter body shaped and configured for advancement into a patient's bladder through the patient's urethra; the catheter body having a distal end and proximal end, the distal end terminating at a distal tip, and a drainage lumen extending from the distal end to the proximal end of the catheter body to provide a urine drainage path when the distal end of the catheter is positioned in the patient's bladder; at least one deployable anchor positioned near the distal end of the catheter body, the anchor configured to hold the catheter in place when the anchor is deployed in the bladder; and at least one nerve stimulation electrode positioned at the distal end of the catheter body, the nerve stimulation electrode configured and positioned on the catheter body so as to be in proximity to a pudendal nerve of the patient to deliver a high frequency current to the patient's pudendal nerve to relax the patient's urinary sphincter as the distal tip of the catheter body is at the urinary sphincter to promote advancement of the catheter body through the urinary sphincter and into the bladder via a reduced resistance force from the urinary sphincter. ### Claim 2 (depends on 1) The urinary drainage catheter of claim 1, further comprising an elongated conductor positioned within the catheter body and having a proximal and distal end, the distal end electrically coupled to the at least one nerve stimulation electrode and the proximal end positioned near the proximal end of the catheter body. ### Claim 3 (depends on 2) The urinary drainage catheter of claim 2, wherein the elongated conductor comprises a wire or a cable. ### Claim 4 (depends on 1) The urinary drainage catheter of claim 1, wherein the at least one nerve stimulation electrode comprises a flexible electrode configured to conform to a contour of the patient's urethra. ### Claim 5 (depends on 4) The urinary drainage catheter of claim 4, wherein the flexible electrode comprises a patch electrode. ### Claim 6 (depends on 4) The urinary drainage catheter of claim 4, wherein the flexible electrode comprises a conductive coating. ### Claim 7 (depends on 1) The urinary drainage catheter of claim 1, the catheter further comprising at least two nerve stimulation electrodes configured to deliver bipolar high frequency current to the patient's pudendal nerve. ### Claim 8 (depends on 7) The urinary drainage catheter of claim 7, wherein a first nerve stimulation electrode is at a first axial location on the catheter body and a second nerve stimulation electrode is at a second axial location on the catheter body. ### Claim 9 (depends on 8) The urinary drainage catheter of claim 8, wherein the first and second electrodes are axially spaced apart by in a range from about 5 to 25 mm. ### Claim 10 (depends on 8) The urinary drainage catheter of claim 8, wherein the first and second electrodes are ring electrodes. ### Claim 11 (depends on 7) The urinary drainage catheter of claim 7, wherein a first nerve stimulation electrode is at a first radial location on the catheter body and a second nerve stimulation electrode is at a second radial location on the catheter body. ### Claim 12 (depends on 11) The urinary drainage catheter of claim 11, wherein the first and second nerve stimulation electrodes are radially spaced apart from another by about 180°. ### Claim 13 (depends on 1) The urinary drainage catheter of claim 1, wherein the deployable anchor comprises an inflatable balloon connected to an inflation lumen in the catheter body. ### Claim 14 (depends on 13) The urinary drainage catheter of claim 13, further comprising a proximal hub positioned at the proximal end of the catheter body, the proximal hub having a first port connected to the drainage lumen, a second port connected to the inflation lumen, and a third port for electrically connecting a cable to the at least one nerve stimulation electrode. ### Claim 15 (depends on 1) The urinary drainage catheter of claim 1, wherein the catheter distal tip comprises an atraumatic tip. ### Claim 16 (depends on 15) The urinary drainage catheter of claim 15, wherein the atraumatic tip comprises a tapered tip or a hemispherical tip. ### Claim 17 (depends on 1) The urinary drainage catheter of claim 1, further comprising an irrigation lumen for irrigating the patient's urethra with the drainage catheter in place, the irrigation lumen extending from the proximal end to a distal portion of the catheter body and having a distal opening for the release of fluid to irrigate or flush the patient's urethra. ### Claim 18 (depends on 1) The urinary drainage catheter of claim 1, further comprising a pressure sensor positioned on the catheter body for measuring a urinary sphincter pressure. ### Claim 19 (depends on 18) The urinary drainage catheter of claim 18, wherein the pressure sensor is positioned on the catheter body near the at least one stimulation electrode or the distal end of the catheter. ### Claim 20 (depends on 1) The urinary drainage catheter of claim 1, further comprising a temperature sensor positioned on the catheter body for measuring tissue temperature near the at least one nerve stimulation electrode. ### Claim 21 (depends on 1) A system comprising: a urinary drainage catheter as in claim 1; and a controller configured to deliver a high frequency current to the at least one nerve stimulation electrode to relax the urinary sphincter. ### Claim 22 (depends on 21) The system of claim 21, further comprising an electrical power source for generating the high frequency current, the power source operatively coupled to the controller. ### Claim 23 (depends on 22) The system of claim 22, wherein the power source is internal to the controller. ### Claim 24 (depends on 21) The system of claim 21, wherein the controller is configured to deliver current at a frequency above 4 kHz, an amperage below 15 mA, and a voltage in a range from 40V to 60V. ### Claim 25 (depends on 21) The system of claim 21, wherein the controller is configured to deliver bipolar current to first and second electrodes on the urinary drainage catheter. ### Claim 26 A system for facilitating urinary drainage of a patient, the system comprising: an elongated flexible catheter body shaped and configured for advancement into a patient's bladder through the patient's urethra; the catheter body having a proximal end and a distal end terminating at a distal tip, and a drainage lumen extending from the distal end to the proximal end of the catheter body to provide a urine drainage path when the distal end of the catheter is positioned in the patient's bladder; at least one deployable anchor positioned near the distal end of the catheter body, the anchor configured to hold the catheter in place when the anchor is deployed in the bladder; at least one nerve stimulation electrode positioned at the distal end of the catheter body, the nerve stimulation electrode configured and positioned on the catheter body so as to be in proximity to a pudendal nerve of the patient when the distal tip of the catheter body is located within the urethra at the urinary sphincter; and a controller coupled to the at least one stimulation electrode, the controller comprising a processor and instructions executable on the processor for controlling delivery of a high frequency current from the least one stimulation electrode through the urethral wall and to the patient's pudendal nerve, the high frequency current formulated to relax the patient's urinary sphincter to thus promote advancement of the catheter body through the urinary sphincter and into the bladder via a reduced resistance force from the urinary sphincter.