Paraurethral Constrained Tissue Repositioning for Incontinence

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Solution Overview

Problem

Current treatments for urinary and fecal incontinence are often invasive, associated with significant side effects, and have limited success, particularly for stress urinary incontinence and fecal incontinence, with existing methods often requiring complex procedures, causing pain, infections, and prolonged recovery times, and failing to effectively restore continence.

Innovation Solution

The development of a paraurethral constraining device system that uses implants to stabilize and reposition the urethra by engaging and pulling the supportive tissue, such as the perineal membrane, to prevent rotational movement and apply mechanical traction, thereby eliminating the need for mesh or other supportive structures under the urethra, and reducing the complexity and invasiveness of the treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mesh or supportive structures are placed under the urethra to treat incontinence, then continence is improved, but the risk of infection and tissue damage increases

Engineering Contradiction:
ImprovecontinenceVSAvoidinfection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the mesh component entirely from the treatment system. Instead of using mesh or supportive structures under the urethra, the invention uses a paraurethral constraining device that applies mechanical traction to reposition and stabilize the urethra through natural tissue structures, thereby eliminating the infection risk associated with foreign mesh materials while maintaining continence treatment effectiveness

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary mechanism (the constraining device with anchoring elements) that mediates between the treatment goal and the tissue. Rather than directly placing mesh under the urethra, the device anchors to surrounding tissue structures and applies controlled traction to achieve urethral repositioning, reducing direct contact with potentially infected areas while maintaining treatment efficacy

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If complex surgical procedures are used to treat incontinence, then continence is improved, but recovery time and patient pain increase

Engineering Contradiction:
ImprovecontinenceVSAvoidrecovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent divides the treatment system into separable components: a constraining device with anchoring elements that can be implanted through minimally invasive techniques. This segmented approach allows for simpler implantation procedures compared to complex mesh placements, reducing surgical trauma and enabling faster patient recovery while maintaining continence treatment effectiveness

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of using complex procedures to achieve simple stabilization, the patent inverts the approach by using a simple constraining device that leverages natural tissue mechanics. The device works by applying mechanical traction in the opposite direction of urethral displacement, achieving stabilization through a reversed but simpler mechanism that reduces procedural complexity and recovery time

Inventive Principle:
Principle #13The other way round (Inversion)

3Reliability

If supportive structures are placed under the urethra, then continence is improved, but cosmetic outcomes and sexual activity are compromised

Engineering Contradiction:
ImprovecontinenceVSAvoidinterference with sexual activity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the problematic mesh component that causes cosmetic and sexual dysfunction. The constraining device is designed to work with natural tissue structures without requiring foreign materials under the urethra, thereby eliminating the bulk and discomfort that interfere with sexual activity while maintaining continence through mechanical traction on surrounding tissues

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs flexible anchoring elements and thin-film constraining structures that conform to natural tissue contours. These flexible components are less intrusive than rigid mesh structures, allowing for better cosmetic outcomes and reduced interference with sexual activity while maintaining the mechanical traction necessary for continence treatment

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS11284983B2Pelvic implant system and method
Publication Date: 2022.03.29 BOSTON SCIENTIFIC SCIMED INC
  • US11284983B2 patent drawing
  • US11284983B2 patent drawing
  • US11284983B2 patent drawing

AI summary

Systems and methods are provided and adapted to engage and pull (e.g., pull up) or reposition paraurethral support tissue, such as the perineal membrane. The perineal membrane intersects the urethra and vagina at the midurethra or distal location and can thus be stabilized or controlled in a manner that helps restore continence. As such, the implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings.