Devices and systems for treatment of urinary incontinence, and methods of making and using same
Inventors
DHAR, NIVEDITA • Majerus, Steven • RICKLI, JEREMY • TOEPPER, TINO • OSMANI, BEKIM • MUELLER, BERT
Assignees
Universitaet Basel • Wayne State University • US Department of Veterans Affairs
Publication Number
US-11903806-B2
Publication Date
2024-02-20
Expiration Date
2039-03-01
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Abstract
An artificial urinary sphincter can include a cuff configured to surround a portion of a length of a urethra. An actuator is configured to selectively apply a force to the cuff to thereby apply variable amount of pressure to the urethra. A controller is configured to adjust the application of the force by the actuator to cause the cuff to apply the variable amount of pressure to the urethra. A sensor can be in communication with the controller and configured to detect pressure applied against the cuff by the urethra. The controller is configured to cause the cuff to apply a first closing pressure to the urethra. In response to a detection of a threshold pressure increase by the sensor, the controller is configured to cause the cuff to apply a second closing pressure that is greater than the first closing pressure and that prevents urine from exiting the urethra.
Core Innovation
The invention disclosed is a smart artificial urinary sphincter (SAUS) device designed to restore urinary continence by dynamically controlling urethral closure pressure. The device includes a cuff configured to surround a portion of the urethra, an electric linear actuator that applies a variable force to the cuff, a controller that adjusts this force, and an array of dielectric elastomer transducer (DET) sensors embedded in the cuff to detect real-time pressure applied against the urethra.
The controller is programmed to maintain a low first closing pressure under normal conditions, sufficient to prevent urine leakage during restful states. Upon detection of sudden increases in intra-abdominal pressure (such as coughing or physical exertion), the sensors register the pressure change and signal the controller, which rapidly increases the cuff to a second, higher closing pressure to prevent urine from exiting the urethra. When the increased pressure subsides, the controller lowers the pressure back to its baseline, thereby mimicking the behavior of a healthy urinary sphincter.
This device addresses the clinical problem of treating neurogenic stress urinary incontinence (NSUI) and stress urinary incontinence (SUI), conditions prevalent in patients after spinal cord injury, prostate surgery, or with anatomical or neurogenic dysfunction, where existing artificial sphincters or slings suffer from high complication rates, static pressure, lack of rapid response, manual operation requirements, and are often unsuitable for certain populations such as women and children. The SAUS provides synchronized, fast, and adaptive pressure regulation using a closed-loop feedback system, offering a promising alternative to established devices.
Claims Coverage
The patent contains two independent claims, each introducing key inventive features related to an artificial urinary sphincter system and its method of use.
Smart artificial urinary sphincter with variable, sensor-driven pressure control
An artificial urinary sphincter comprises: - A cuff designed to surround a portion of the urethra, with a housing and retractable/protractable band. - An electric linear actuator that retracts and protracts the band relative to the housing, selectively applying a variable force to the cuff. - A controller electrically communicating with the actuator and adjusting force application to vary cuff pressure on the urethra. - At least one sensor, integrated into or coupled to the cuff, consisting of an array of dielectric elastomer transducers (with metal electrodes embedded in elastic elastomer membrane), detecting pressure exerted by the urethra on the cuff. - The controller is configured to maintain a first closing pressure and, in response to a threshold pressure increase detected by the sensor, increase to a second closing pressure sufficient to prevent urine from exiting the urethra.
Method for dynamic, sensor-activated increase of urethral closure pressure
A method includes: 1. Implanting the artificial urinary sphincter in a patient, where the sphincter system includes the sensor-driven, variable-pressure features as described. 2. Detecting, using the sensor, a pressure measurement above a predefined threshold. 3. In response to receiving this pressure measurement exceeding the threshold, generating a signal to the actuator causing the cuff to apply a second, higher closing pressure to prevent urine exit from the urethra.
The inventive features cover both the specific system architecture of a sensor- and processor-controlled, electromechanical artificial urinary sphincter and the method for utilizing pressure detection to activate a rapid, variable urethral closure to prevent incontinence.
Stated Advantages
Provides dynamic, sensor-driven urethral cuff pressure to improve continence and minimize urethral damage.
Enables low resting urethral cuff pressure and high, rapid pressure response only when needed, decreasing rates of urethral atrophy, erosion, and infection compared to conventional devices.
Eliminates the need for hydraulic systems, reducing the incidence of fluid leaks and associated surgical revisions.
Does not require fine motor skills or manual operation; can be controlled remotely, benefitting patients with limited dexterity.
Allows for simpler surgical implantation and lower production cost due to its straightforward geometry and lack of scrotal components.
Is suitable for both male and female patients and can be controlled with patient- or disease-specific algorithms.
Permits fast, closed-loop feedback with response times below 30 milliseconds, mimicking the natural sphincter’s dynamic function.
Documented Applications
Treatment of neurogenic stress urinary incontinence (NSUI) in spinal cord injury patients.
Treatment of stress urinary incontinence (SUI) in women, including those with congenital or acquired bladder outlet incompetence.
Post-prostatectomy incontinence treatment in male patients.
Management of urinary incontinence in pediatric patients with incompetent bladder outlets or neurogenic bladder dysfunction.
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