Device, systems and methods for treatment of neurogenic bladder
Inventors
Assignees
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Publication Number
US-12133980-B2
Publication Date
2024-11-05
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 document describes techniques for treating neurogenic bladder by delivering external urethral sphincter stimulation (EUSS) to relax an external urethral sphincter (EUS) prior to urination. An EUSS catheter/device includes nerve stimulation electrodes positioned to deliver electrical current to nerves within and/or around the external urethral sphincter to influence urination control. The system/control uses selected electrical waveform frequencies to achieve stimulation effects on pudendal signals and/or sacral nerve stimulation effects for coordinated urination.
The document further provides a minimally invasive urethral approach for positioning an EUSS catheter/device in urinary tissue. A guiding catheter is positioned in a urethra such that an exit port is proximate the external urethral sphincter, and an EUSS catheter/device is advanced through a lumen so a tissue-penetrating end of a distal portion penetrates into tissue adjacent the external urethral sphincter and exits into the perineum. The distal portion is then drawn back until a proximal anchor is lodged in or adjacent to urethral wall tissue such that one or more electrodes are positioned proximate the external urethral sphincter.
After electrode positioning, a distal tether portion is tunneled to a buttocks and/or back area so a connector on the EUSS catheter/device is positioned at a connection location. The distal portion is then disconnected from the EUSS catheter/device leaving the connector at the connection location. The document also describes options for proximal anchor and electrode configurations and includes safety control based on energy and/or temperature monitoring, as well as post-connection integrity testing using test signals.
Claims Coverage
The provided excerpt includes two independent methods that share a common catheter/device positioning sequence and end with tunneling and leaving a connector at a connection location. Across the independent claims, three main inventive features are emphasized: urethral guiding catheter placement relative to the external urethral sphincter, a tissue-penetrating distal portion that exits into the perineum followed by drawing back to lodge a proximal anchor, and tunneling a distal tether to position a connector for connection and then disconnecting the distal portion.
Urethral guiding catheter positioning with exit port near external urethral sphincter
Positioning a guiding catheter in a urethra of the patient so that an exit port of the guiding catheter is proximate the patient's external urethral sphincter.
Tissue-penetrating distal portion advance and perineum exit followed by proximal anchor lodging and electrode proximity
Advancing the EUSS catheter/device through a lumen of the guiding catheter such that a tissue-penetrating end of a distal portion penetrates the urethra into tissue adjacent the external urethral sphincter and exits out of tissue into the patient's perineum, and drawing the distal portion from the perineum area until a proximal anchor is lodged in or adjacent to tissue of urethral wall such that one or more electrodes are positioned proximate the external urethral sphincter.
Distal tether tunneling to buttocks/back to leave connector at connection location
Tunneling a distal tether portion from the EUSS catheter/device to a location in the patient's buttocks and/or back area such that a connector on the EUSS catheter/device is positioned at a connection location, and disconnecting the distal portion from the EUSS catheter/device leaving the connector at the connection location.
The independent claims cover positioning an EUSS catheter/device by guiding it to an exit port proximate the external urethral sphincter, advancing a tissue-penetrating distal portion that exits into the perineum and drawing it back until a proximal anchor lodges with electrodes proximate the external urethral sphincter, followed by tunneling a distal tether to position a connector and disconnecting the distal portion to leave the connector at the connection location.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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