Neurostimulation Therapy Timing via Bladder Cycle Detection
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Solution Overview
Problem
Current medical devices delivering neurostimulation therapy for conditions like overactive bladder and urinary incontinence often provide continuous stimulation, leading to undesirable side effects, reduced efficacy, and increased energy usage, as they do not accurately time therapy with the patient's physiological cycles.
Innovation Solution
A system that monitors physiological markers to timing the delivery of neurostimulation therapy, withholding it during unnecessary phases and delivering it during more effective phases of the bladder fill cycle, such as the second phase after a voiding event, to reduce or eliminate dysfunctional states like urinary incontinence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If continuous neurostimulation therapy is delivered, then therapy coverage is maintained, but side effects increase and efficacy decreases
Solution Approach 1:
The system transitions from continuous neurostimulation to periodic/phased delivery based on bladder fill cycle detection. Neurostimulation is delivered during specific phases (e.g., when bladder is full) and withheld during other phases, creating a periodic action pattern that maintains therapeutic efficacy while reducing side effects and energy consumption.
Solution Approach 2:
The system detects physiological markers (bladder fullness) in advance and times neurostimulation delivery accordingly. By identifying the optimal phase for therapy delivery before administering treatment, the system ensures maximum efficacy while avoiding unnecessary stimulation during inappropriate phases.
2Reliability
If continuous neurostimulation therapy is delivered, then therapy coverage is maintained, but energy usage increases
Solution Approach 1:
The system implements periodic neurostimulation delivery synchronized with the bladder fill cycle, activating therapy only during phases when the bladder is full and withholding during other phases. This periodic action maintains necessary therapy coverage while significantly reducing overall energy consumption compared to continuous delivery.
Solution Approach 2:
The system delivers neurostimulation partially - only during the specific phase when the bladder is full - rather than continuously. This partial action is sufficient to achieve therapeutic goals while minimizing energy usage by avoiding stimulation during phases when it is not needed.
3Reliability
If neurostimulation is timed to specific phases, then therapy efficacy increases, but device complexity increases
Solution Approach 1:
The system uses feedback from physiological sensors that detect bladder fullness and other markers to automatically determine when to deliver neurostimulation. This feedback mechanism enables phase-timed therapy delivery without requiring complex manual programming or control algorithms, as the physiological signals themselves guide the timing.
Solution Approach 2:
The system leverages the patient's own physiological signals (bladder fullness, voiding events) to automatically control neurostimulation timing. The body's natural physiological markers serve as the control input, eliminating the need for external monitoring or complex decision-making logic in the device.
Data Source
AI summary
Devices, systems, and methods may manage therapy delivery to a patient based on one or more physiological markers. In some examples, a method includes detecting a physiological marker that occurs prior in time to a dysfunctional phase of a physiological cycle, wherein a dysfunctional state of the physiological cycle occurs during the dysfunctional phase without treatment, responsive to detecting the physiological marker, initiating a first phase of the physiological cycle having a duration of time. The method may also include, responsive to the first phase elapsing, controlling a therapy delivery module to deliver neurostimulation therapy during a second phase that begins prior to the dysfunctional phase, wherein the neurostimulation therapy is configured to treat the dysfunctional state.