System and method for detecting an endo-urethral device for an artificial sphincter that is implantable in an animal or human body
Inventors
Lamraoui, Hamid • Mozer, Pierre
Assignees
Assistant Publique Hopitaux De Paris • Assistance Publique Hopitaux de Paris APHP • Uromems SAS
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Publication Number
US-10736563-B2
Publication Date
2020-08-11
Expiration Date
Abstract
The invention relates to a detection system of an endo-urethral device for an artificial urinary sphincter implantable in the body of a patient, said sphincter comprising an occlusive cuff (2) adapted to compress the urethra, the bladder neck or the prostate of said patient, an activation device (5) of said cuff (2) and a control unit (6) adapted to control the activation device.Said system comprises at least one compression sensor (13) of the urethra and a posture sensor (9), and a processing unit (30) configured to determine: (i) if the compression parameter of the urethra exceeds a predetermined threshold during a predetermined period,(ii) if the patient is in a recumbent position. If the conditions (i) and (ii) are fulfilled, the processing unit sends to the activation device (5) an immediate reduction order of the compression exerted by the cuff (2).
Core Innovation
The invention relates to an implantable artificial urinary sphincter that prevents urethral erosion during endo-urethral device introduction by detecting a condition of increased compression and patient posture, and triggering immediate cuff decompression only when predetermined conditions are fulfilled. The artificial urinary sphincter comprises an occlusive cuff configured to compress a selected one of a urethra, a bladder neck and a prostate, and an activation device coupled to the cuff for adjusting a compression amount exerted by the cuff. The activation device comprises a reservoir, tubing fluidly coupling the occlusive cuff and the reservoir, and an actuator configured to transfer fluid between the reservoir and the occlusive cuff.
The invention further provides at least one compression sensor configured to measure a compression parameter of the selected one of the urethra, the bladder neck and the prostate, and at least one posture sensor configured to measure a posture parameter of the patient. A processing unit comprising a microcontroller, a clock and a memory receives measurement data from the compression and posture sensors. The processing unit determines that the compression parameter exceeds a predetermined compression threshold during a predetermined period and determines that the patient is in a decubitus dorsal position and is substantially immobile, and then selectively sends an order to reduce the compression amount exerted by the occlusive cuff based on both conditions.
In addition, the invention includes embodiments for different activation and compression-reduction scenarios, including hydraulic activation devices and mechanical activation devices connected by a cable to the cuff, where a compression parameter is determined from pressure sensing or mechanical tension sensing. The invention also supports detecting the introduction of an endo-urethral device only when the compression condition is fulfilled and the patient is in a lying position. A stress-reduction element is activated to reduce mechanical stresses undergone by the activation device while maintaining the compression exerted by the cuff above the predetermined detection threshold.
Claims Coverage
The partial content includes multiple independent claims (clm-00001, clm-00007, clm-00008, clm-00010, clm-00011, clm-00012, clm-00013). Across these independent claims, the core coverage is based on combined compression-threshold detection over a predetermined period together with posture-based immobility/position conditions, followed by selectively sending an immediate reduction order to the activation device, with hydraulic and mechanical activation-device variations.
Threshold-based combined compression and posture detection for selective cuff decompression
A processing unit receives measurement data from compression and posture sensors, determines that the compression parameter exceeds a predetermined compression threshold during a predetermined period, determines that the patient is in a decubitus dorsal position and substantially immobile, and selectively sends to the activation device an order to reduce the compression amount exerted by the occlusive cuff based on both conditions.
Compression-threshold detection conditioned on posture and constrained by iteration/timing logic
A processing unit implemented by a computer program reads a signal of the compression parameter, compares it with a predetermined detection threshold, determines an immobile position of the patient if the posture parameter is under a predetermined upper limit, determines the position of the patient in decubitus dorsal, repeats preceding steps during a predetermined number of iterations, and sends an immediate reduction order of the compression exerted by the occlusive cuff.
Immediate reduction logic for hydraulic activation using seated immobile torso and thresholded compression
For a hydraulic activation device, the processing unit determines that the compression parameter exceeds a predetermined detection threshold during a predetermined period without an order being sent to reduce the compression, determines that the patient is in a seated position and the torso is substantially immobile, and selectively sends to the hydraulic activation device an order to immediately reduce the compression exerted by the occlusive cuff based on both conditions.
Endo-urethral device introduction detection conditioned on compression-threshold and lying position with stress reduction
A method measures at least one compression parameter and a posture parameter, determines that the compression parameter exceeds a predetermined detection threshold during a predetermined period without an order being sent to reduce cuff compression, determines that the patient is in a lying position, detects introduction of the endo-urethral device only if the conditions are fulfilled, and activates a stress-reduction element to reduce stresses undergone by the activation device while maintaining cuff compression above the predetermined detection threshold.
Mechanical tension-based compression parameter detection with seated immobile condition
For a mechanical activation device connected by a cable to the cuff, the compression parameter is determined from mechanical tension of the cable, and the processing unit determines that the compression parameter exceeds a predetermined detection threshold during a predetermined period without an order being sent to reduce compression, determines that the patient is in a seated position and the torso is substantially immobile, and selectively sends to the mechanical activation device an order to immediately reduce the compression exerted by the occlusive cuff.
Decubitus dorsal immobility with mechanical tension-based compression parameter reduction
For a mechanical activation device connected by a cable to the cuff, a processing unit determines that the compression parameter exceeds a predetermined compression threshold during a predetermined period, determines that the patient is in a decubitus dorsal position and substantially immobile, and selectively sends to the mechanical activation device an order to reduce the compression amount exerted by the occlusive cuff.
Across the independent claims, the inventive coverage is directed to implantable artificial urinary sphincters and a detection method that combine compression-parameter threshold detection over a predetermined period with posture determination, followed by an immediate reduction order when the combined conditions are fulfilled. The coverage includes hydraulic and mechanical activation devices, endo-urethral device introduction detection, and activation of a stress-reduction element.
Stated Advantages
Prevents urethral erosion during endo-urethral procedures by triggering cuff decompression when predetermined compression and posture conditions are fulfilled.
Documented Applications
Detection of the introduction of an endo-urethral device in a patient wearing an artificial urinary sphincter, with conditions based on measured compression parameter and patient posture.
Special handling for paraplegic patients who catheterize while seated [procedural detail omitted for safety].
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