Device, systems and methods for treatment of neurogenic bladder
Inventors
Assignees
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Publication Number
US-11794001-B2
Publication Date
2023-10-24
Expiration Date
Abstract
Embodiments of the invention provide apparatus, systems and methods for stimulating tissue in the urinary tract to initiate or facilitate urination. One embodiment provides an external urinary sphincter stimulation (EUSS) catheter for stimulating the external urinary sphincter (EUS), where the EUSS catheter includes nerve stimulation electrodes (NSES) for delivering current to nerves within or around the EUS in order to relax the EUS prior to urination. Other embodiments provide a system for stimulating the EUS including the EUSS catheter and a controller operatively coupled to the EUSS catheter, where the controller includes a pulse generator for delivering current to the NSES. Other embodiments provide methods for positioning the EUSS catheter in the patient's body including in the EUS using a urethral approach. Embodiments of the invention are particularly useful for initiating and/or controlling urination for patients who have lost the ability to voluntarily urinate due to neurogenic bladder dysfunction.
Core Innovation
The invention relates to a catheter for electrical stimulation of a patient's external urinary sphincter (EUS). The catheter includes a catheter body with a distal end and a proximal end, sized and configured for advancement through a lumen of a guiding catheter. The proximal end includes an anchoring element configured to anchor the proximal end in the patient's EUS or urethral wall, and the catheter body carries at least one nerve stimulation electrode positioned near the proximal end distally of the anchoring element.
The at least one nerve stimulation electrode is configured to deliver a high frequency current to the EUS to block signals from the patient's pudendal nerve and relax the patient's EUS. The catheter further includes at least one connector element positioned on a distal portion of the catheter body and electrically coupled to the at least one nerve stimulation electrode, where the connector element is configured to connect to a pulse generator.
The catheter also includes a distal tether detachably attached to the distal end, with a tissue-penetrating distal tip configured to penetrate the urethral wall and exit tissue on the posterior as the catheter body is advanced. The described system-level arrangement includes electrical stimulation configured to relax or open the EUS by blocking pudendal-nerve signals using high frequency current, and includes optional sacral nerve stimulation to contract or relax the bladder.
Claims Coverage
The independent claim recites an anchoring-and-electrode EUS stimulation catheter that anchors in the EUS or urethral wall and positions electrodes to deliver high frequency current that blocks pudendal-nerve signals to relax the EUS. Dependent refinements add specific electrode placement and arrangements, anchoring element configurations, tether features, and quantified system-level stimulation and catheter material constraints.
Anchoring-and-intralumen EUS catheter advancement through a guiding catheter
A catheter having a catheter body sized and configured for advancement through a lumen of a guiding catheter, and an anchoring element positioned at the proximal end configured to anchor the proximal end in the patient's EUS or urethral wall.
High frequency EUS nerve stimulation to block pudendal nerve signals
At least one nerve stimulation electrode positioned near the proximal end distally of the anchoring element such that the at least one nerve stimulation electrode is positioned in or proximate the EUS when the anchoring element is anchored, where the at least one nerve stimulation electrode is configured to deliver a high frequency current to the EUS to block signals from the patient's pudendal nerve to relax the patient's EUS.
Connector element for pulse generator coupling
At least one connector element positioned on a distal portion of the catheter body and electrically coupled to the at least one nerve stimulation electrode, where the at least one connector element is configured to connect to a pulse generator.
Tissue-penetrating distal tether for anchoring element lodging
A distal tether detachably attached to the distal end of the catheter body, the distal tether having a tissue-penetrating distal tip to penetrate the urethral wall and exit tissue on the patient's posterior as the catheter body is advanced, where the distal tether is configured to be pulled from its distal end to lodge the anchoring element in the EUS or urethral wall.
Pulse generator delivering current with defined thresholds
The system includes a pulse generator configured to deliver current at a frequency above 4 kHz, with an amperage below 15 mA and a voltage between 40 V and 60 V.
Bipolar current delivery to electrode(s)
The system is configured so the pulse generator delivers bipolar current to the first and second electrodes of the nerve stimulation electrode(s) on the catheter body.
Opposite-side electrode arrangement
The catheter includes an anchoring element where the nerve stimulation electrodes are arranged such that a first electrode is positioned on one side of the catheter body and a second electrode is positioned on the opposite side.
Ball-shaped anchoring element with larger diameter
The catheter includes an anchoring element that has a ball shape whose diameter is larger than the diameter of the catheter body’s proximal end.
Catheter body material with constrained Shore A hardness
The catheter body is made of material having a Shore A hardness in the range from about 30 to 90.
Overall, the claim coverage centers on an anchoring-and-electrode configuration that places EUS nerve stimulation electrodes near the EUS and delivers high frequency current to block pudendal nerve signals to relax the EUS, coupled to a pulse generator. Refinements further specify electrode geometry and positioning, tether and anchoring configurations, and current thresholds and catheter material hardness.
Stated Advantages
Relaxes the patient's external urinary sphincter (EUS) by blocking signals from the patient's pudendal nerve.
Provides minimally invasive external urinary sphincter electrical stimulation using a catheter advanced through a lumen of a guiding catheter.
Reduces burdens associated with conventional approaches such as Foley catheter use, as asserted in the provided content.
Documented Applications
Treatment of neurogenic-bladder dysfunction using electrical stimulation of the external urinary sphincter (EUS) via an EUSS catheter and optional sacral nerve stimulation.
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