Conditional Electrical Stimulation for Pelvic Health
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Solution Overview
Problem
Current treatments for pelvic floor disorders such as urinary incontinence and pelvic pain often rely on continuous electrical stimulation, which can lead to undesirable side effects like nerve fatigue and increased power consumption, limiting device longevity and increasing the frequency of device replacements.
Innovation Solution
An implantable medical device (IMD) that adjusts the delivery cycle of electrical stimulation based on a time schedule, user input, or physiological information, reducing the overall stimulation amount and power consumption, thereby minimizing side effects and promoting device longevity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If continuous electrical stimulation is applied to treat pelvic floor disorders, then therapeutic effectiveness is maintained, but nerve fatigue and accommodation occur leading to treatment failure
Solution Approach 1:
The patent implements periodic electrical stimulation by delivering stimulation pulses in cyclical patterns with defined on-periods and off-periods. The controller alternates between delivering stimulation pulses and withholding them, creating a periodic action that prevents nerve fatigue while maintaining therapeutic effectiveness. This is achieved through the controller's logic that monitors time intervals and selectively activates the stimulation based on predefined periodic patterns.
Solution Approach 2:
The patent applies dynamics by making the stimulation delivery adaptive and variable rather than static. The controller dynamically adjusts the stimulation parameters including pulse frequency, amplitude, and delivery timing based on detected physiological conditions such as muscle contraction status, bladder fullness, or bowel movement patterns. This dynamic adjustment ensures optimal therapeutic effect while preventing nerve accommodation.
2Reliability
If continuous electrical stimulation is applied to ensure therapeutic coverage, then symptom management is maintained, but power consumption increases reducing device longevity
Solution Approach 1:
The patent reduces power consumption by implementing periodic stimulation patterns that include off-periods where no stimulation is delivered. Instead of continuous power consumption, the device operates in cycles, delivering stimulation only during necessary on-periods and conserving energy during off-periods. This periodic operation significantly extends battery life while maintaining therapeutic effectiveness through strategically timed stimulation delivery.
Solution Approach 2:
The patent enables the device to autonomously manage its own power consumption by incorporating sensors that detect physiological conditions and automatically adjust stimulation delivery accordingly. The controller monitors parameters such as muscle activity, bladder pressure, or bowel movement indicators and self-regulates the stimulation pattern without external intervention, optimizing power usage based on real-time physiological needs.
3Reliability
If high-frequency stimulation is used to overcome nerve accommodation, then therapeutic effect is maintained, but nerve fatigue accelerates leading to faster treatment failure
Solution Approach 1:
The patent combats nerve accommodation not by increasing frequency continuously but by implementing periodic variation in stimulation patterns. The controller delivers stimulation in bursts separated by off-periods, and may vary the frequency, amplitude, or pulse width between different periodic cycles. This periodic variation keeps the nerve responsive without causing the cumulative fatigue that results from sustained high-frequency stimulation.
Solution Approach 2:
The patent uses dynamic parameter adjustment to maintain therapeutic effectiveness while extending treatment duration. The controller varies stimulation parameters such as frequency, amplitude, and pulse duration in response to detected physiological conditions and elapsed time. This dynamic adaptation prevents nerve accommodation by continuously changing the stimulation profile, thereby extending the effective treatment duration without accelerating nerve fatigue.
4Duration of action of stationary object
If implantable medical devices are made larger to include more powerful batteries, then device longevity increases, but surgical implantation complexity and patient discomfort increase
Solution Approach 1:
The patent enables smaller device size by implementing periodic stimulation patterns that dramatically reduce average power consumption. By delivering stimulation in intermittent bursts rather than continuously, and by including off-periods in the stimulation cycle, the device requires much smaller battery capacity to achieve the same or longer operational lifespan. This periodic operation allows compact device design without sacrificing longevity.
Solution Approach 2:
The patent changes the operational parameters of the device to enable smaller size. By transitioning from continuous high-power operation to periodic low-average-power operation, and by dynamically adjusting stimulation parameters based on physiological needs, the device achieves extended lifespan with reduced power consumption. This parameter change allows the use of smaller, less invasive implantable components.
Data Source
AI summary
In general, the disclosure describes techniques for providing conditional electrical stimulation to a patient for pelvic health. An implantable medical device (IMD) may adjust the delivery cycle of the electrical stimulation applied to a patient in response to receiving a delivery cycle parameter associated with one or more of the following: a time in a time schedule, a control device output from a control device, and physiological information from a physiological information sensing device. As an example, the IMD may monitor a status of one or more inputs of the IMD and adjust the delivery cycle of the electrical stimulation applied to the patient based on the status of the input(s).