Implantable Electrical Stimulation for Pelvic Floor Dysfunction

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Solution Overview

Problem

Current electrical stimulation therapies for pelvic floor disorders often fail to selectively address both lower urinary tract dysfunction and sexual reflex response dysfunction simultaneously, as they require different stimulation parameters and can have incidental effects on either urinary or sexual functions.

Innovation Solution

A system and method that delivers three distinct electrical stimulation therapies: one to reduce bladder contraction frequency, another to improve sexual reflex response, and a third to both inhibit voiding and enhance sexual response, allowing for user-input selection based on specific physiological responses, using an implantable medical device (IMD) with leads and an external programmer to adjust stimulation parameters like frequency and amplitude.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimulation therapy is used to treat lower urinary tract dysfunction, then bladder contraction frequency is reduced, but sexual reflex response may be impaired

Engineering Contradiction:
Improvelower urinary tract dysfunction treatment efficacyVSAvoidsexual function impact
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent divides the electrical stimulation therapy into multiple distinct programs (first electrical stimulation therapy for urinary dysfunction, second for sexual dysfunction, third for combined effects). Each program uses specific parameter settings tailored to its therapeutic goal, allowing independent optimization of urinary and sexual functions without interfering with each other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system varies electrical stimulation parameters (frequency, amplitude, pulse width, duty cycle) across different therapy programs. By adjusting these parameters selectively, the system achieves bladder contraction frequency reduction for urinary dysfunction while maintaining or improving sexual reflex response, resolving the contradiction between treating one function without harming the other.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If electrical stimulation therapy is used to improve sexual reflex response, then sexual response time is reduced, but bladder contraction frequency may increase

Engineering Contradiction:
Improvesexual reflex response improvementVSAvoidurinary function impact
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent separates therapeutic functions into distinct stimulation programs. The second electrical stimulation therapy is specifically designed for sexual dysfunction with parameter settings that optimize sexual reflex response while the third program addresses combined effects. This segmentation prevents the unintended increase in bladder contraction frequency that would occur with a single unified stimulation approach.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system employs different electrical stimulation parameters for different therapeutic objectives. When treating sexual dysfunction, the system uses parameter combinations that reduce sexual response time while maintaining bladder function stability. The ability to switch between parameter sets based on therapeutic needs allows improvement of sexual function without compromising urinary control.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If a single electrical stimulation therapy is used to address multiple pelvic floor disorders, then device complexity is reduced, but treatment specificity and efficacy decrease

Engineering Contradiction:
Improvestimulation therapy systemVSAvoidtreatment efficacy for specific conditions
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The electrical stimulation system is designed as a multi-functional device capable of delivering different therapy programs for various pelvic floor disorders. The single system can provide first therapy for urinary dysfunction, second therapy for sexual dysfunction, and third therapy for combined effects, eliminating the need for multiple separate devices while maintaining high treatment efficacy through programmable parameter adjustments.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system dynamically adjusts stimulation parameters based on the selected therapy program and patient needs. By making the device adaptable through programmable changes in frequency, amplitude, and pulse characteristics, the system achieves treatment specificity for different conditions without increasing physical complexity. The device can transition between different therapeutic modes as needed.

Inventive Principle:
Principle #15Dynamics

4Reliability

If multiple electrical stimulation therapies are delivered simultaneously, then comprehensive treatment coverage is improved, but patient comfort and sensory discrimination decrease

Engineering Contradiction:
Improvecomprehensive pelvic floor disorder treatmentVSAvoidpatient comfort and sensation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements separate electrical stimulation programs that can be delivered independently or in combination. The system allows selective delivery of first, second, or third therapies based on patient needs and comfort preferences. By segmenting the stimulation into distinct programs with different parameter characteristics, the system maintains patient comfort and sensory discrimination while providing comprehensive treatment coverage when multiple programs are needed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system varies electrical parameters (frequency, amplitude, pulse width) across different therapy programs to optimize both treatment efficacy and patient comfort. By adjusting these parameters selectively for each program, the system achieves comprehensive treatment coverage for different pelvic floor disorders while maintaining acceptable sensory profiles and patient comfort, avoiding the discomfort that would result from delivering all stimulations simultaneously at high intensities.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The system effectively reduces bladder contraction frequency while improving sexual reflex response, providing targeted therapy for pelvic floor disorders by selectively delivering appropriate electrical stimulation therapies based on user input, enhancing treatment efficacy and patient control.

Implementation Method 1

a first electrical stimulation therapy that is configured to elicit an inhibitory physiological response from the patient related to voiding (e.g., reduce a bladder contraction frequency of the patient)

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

a second electrical stimulation therapy that is configured to improve a sexual reflex response (e.g., shorten a response period) of the patient to a sexual stimulus

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentUS9186509B2Electrical stimulation therapy for lower urinary tract dysfunction and sexual reflex dysfunction
Publication Date: 2015.11.17 MEDTRONIC INC
  • US9186509B2 patent drawing
  • US9186509B2 patent drawing
  • US9186509B2 patent drawing

AI summary

Electrical stimulation therapy may be delivered to a patient to selectively and independently address different conditions of a pelvic floor disorder of the patient. The conditions of a pelvic floor disorder may include, for example, a lower urinary tract dysfunction (e.g., urinary or fecal incontinence) and sexual dysfunction (e.g., an impaired sexual reflex response to a sexual stimulus). In some examples, a system is configured to selectively deliver a first electrical stimulation therapy that is configured to elicit an inhibitory physiological response from the patient related to voiding, a second electrical stimulation therapy that is configured to improve a sexual reflex response of the patient to a sexual stimulus, and a third electrical stimulation therapy that is configured to both elicit the inhibitory physiological response from the patient related to voiding and increase a sexual response of the patient to a sexual stimulus.