Bilateral Stimulation Therapy for Bladder Dysfunction

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Solution Overview

Problem

Current medical devices for treating bladder dysfunction, such as overactive bladder and urinary incontinence, often fail to effectively manage symptoms due to improper communication between the nervous system and the urinary sphincter, leading to inadequate therapeutic responses.

Innovation Solution

A system that delivers a first electrical stimulation therapy and, upon detecting a trigger event, switches to a second stimulation therapy involving substantially simultaneous bilateral stimulation at intensities greater than or equal to a threshold, targeting both lateral sides of the patient to evoke a threshold physiological response, thereby reducing bladder contraction frequency and preventing involuntary voiding events.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional electrical stimulation therapy is delivered to treat bladder dysfunction, then the therapy aims to improve bladder control, but the therapy fails to effectively manage symptoms due to improper communication between the nervous system and the urinary sphincter

Engineering Contradiction:

Improvetherapeutic response effectivenessVSAvoidresponse to trigger events

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The stimulation therapy transitions from a static, fixed protocol to a dynamic, adaptive system that detects trigger events (such as bladder contractions or patient sensations) and adjusts stimulation parameters in real-time. The system dynamically switches between different stimulation modes (unilateral, bilateral, simultaneous) based on detected physiological states, enabling effective management of bladder dysfunction by adapting to the patient's immediate needs.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback mechanisms where physiological signals (such as EMG signals from pelvic floor muscles or bladder pressure sensors) are continuously monitored. This feedback informs the control logic to adjust stimulation delivery, ensuring the therapy responds appropriately to the patient's physiological state and improves therapeutic effectiveness by addressing the root cause of improper nervous system communication.

Inventive Principle:

Principle #23Feedback

2Use of energy by moving object

If unilateral stimulation is delivered at lower intensity, then energy consumption is reduced, but the physiological response is insufficient to effectively treat bladder dysfunction

Engineering Contradiction:

Improvestimulation energy consumptionVSAvoidtherapeutic effect adequacy

Core Design Contradiction:

Use of energy by moving objectVSReliability

Solution Approach 1:

The system employs partial action by delivering stimulation at the minimum effective intensity required to elicit a therapeutic response, rather than continuously using high intensity. When trigger events are detected, the system escalates to bilateral simultaneous stimulation at higher intensities only when necessary, thereby optimizing energy consumption while ensuring adequate therapeutic effect through targeted intensity adjustment.

Inventive Principle:

Principle #16Partial or excessive action

Solution Approach 2:

The stimulation intensity parameter is dynamically adjusted based on detected physiological states. The system transitions between low-intensity unilateral stimulation during stable periods and high-intensity bilateral simultaneous stimulation during trigger events, optimizing the balance between energy consumption and therapeutic effectiveness by changing intensity parameters in response to patient needs.

Inventive Principle:

Principle #35Parameter changes

3Use of energy by moving object

If bilateral stimulation is delivered at different times (alternating), then energy consumption is reduced, but the stimulation periods do not overlap and may be less effective for evoking strong physiological responses

Engineering Contradiction:

Improvestimulation energy consumptionVSAvoidphysiological response speed

Core Design Contradiction:

Use of energy by moving objectVSSpeed

Solution Approach 1:

The system uses periodic alternating bilateral stimulation during baseline therapy to conserve energy, delivering stimulation to left and right sides in sequence. However, upon detecting trigger events, it transitions to simultaneous bilateral stimulation where both sides are stimulated at the same time, creating overlapping stimulation periods that evoke faster and stronger physiological responses when clinically necessary, thus balancing energy efficiency with response speed.

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS8706233B2Stimulation therapy including substantially simultaneous bilateral stimulation

Publication Date: 2014.04.22 MEDTRONIC INC

AI summary

In some examples, a medical device delivers a first electrical stimulation therapy to a patient, and, upon detecting a trigger event, delivers a second electrical stimulation therapy to the patient. In some examples, the first stimulation therapy includes unilateral stimulation or stimulation delivered to both lateral sides of the patient at different times at a stimulation intensity lower than, equal to, or greater than a threshold intensity level for the patient, or bilateral stimulation delivered substantially simultaneously to both lateral sides of the patient, where one lateral side of the patient receives stimulation at an intensity level that is lower than the threshold intensity level and the other lateral side receives stimulation at an intensity level that is greater than or equal to the threshold intensity level. The second stimulation therapy may include substantially simultaneous bilateral stimulation therapy at an intensity level that at or above the threshold intensity level.