Inflatable Stomal Implant Pressure Gradient Sealing

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Solution Overview

Problem

Current prosthetic solutions for ostomy patients, such as colostomy and urostomy, face challenges with non-irrigation systems including difficulty in hiding and securely attaching pouches, odor issues, frequent emptying, skin irritation, and social and sexual problems, along with unreliable watertight seals and gas buildup.

Innovation Solution

An inflatable stomal implant with a longitudinal portion encircling the bowel, a removable closure, and pressure-exerting devices creating a pressure gradient for controlled evacuation, mimicking the anorectal sphincter's function to provide hermetic sealing and reduce incontinence risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a pouch is used for non-irrigation systems, then fecal or urine collection is achieved, but the pouch is difficult to hide and securely attach, and odor is frequently detectable

Engineering Contradiction:

Improvesealing reliabilityVSAvoidattachment ease

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The implant is divided into multiple inflatable segments or zones along the longitudinal portion, allowing independent control of different sections to achieve both secure attachment and reliable sealing without requiring a large external pouch

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent replaces the mechanical pouch attachment system with an inflatable implant that uses pressure gradients and physiological pressure to achieve secure attachment and sealing, eliminating the need for external pouches and their associated attachment problems

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Quantity of substance

If a pouch is used for non-irrigation systems, then fecal or urine collection is achieved, but frequent emptying is required

Engineering Contradiction:

Improvewaste capacityVSAvoidemptying frequency

Core Design Contradiction:

Quantity of substanceVSLoss of time

Solution Approach 1:

The implant enables continuous containment of waste products through maintained inflation pressure, allowing patients to go longer periods without emptying compared to traditional pouches, and facilitates controlled evacuation on demand rather than frequent scheduled emptying

Inventive Principle:

Principle #20Continuity of useful action

3Reliability

If a cover is placed over the stoma, then waste matter is retained, but gas buildup occurs within the bowel

Engineering Contradiction:

Improvesealing reliabilityVSAvoidgas buildup

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The implant applies pressure locally at the stoma site to achieve sealing while maintaining lower pressure in the distal bowel sections, allowing gas to escape distally while preventing leakage at the stoma, thus avoiding gas buildup

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The gradient pressure system continuously allows gas to pass through the implant in the distal direction while maintaining sealing at the proximal stoma, preventing gas accumulation without compromising waste retention

Inventive Principle:

Principle #20Continuity of useful action

4Reliability

If uniform pressure is applied to close the bowel, then sealing is achieved, but risk of ischemia increases

Engineering Contradiction:

Improvesealing reliabilityVSAvoidischemia risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant creates a pressure gradient with higher pressure at the proximal stoma site for sealing and lower pressure in distal sections, maintaining sealing effectiveness while reducing the risk of ischemia in the bowel wall through decreased distal pressure

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The implant applies pressure selectively only where needed for sealing (proximal end) rather than uniformly across the entire bowel, using partial action to achieve sealing while minimizing harmful effects on blood flow in other sections

Inventive Principle:

Principle #16Partial or excessive action

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 implant allows for convenient and reliable fecal or urinary evacuation, reducing odor and skin issues, enabling patients to engage in activities like swimming without scheduled irrigation, and minimizing the risk of ischemia and incontinence.

Implementation Method 1

activation of the pressure-exerting device results in a pressure gradient over a section of the bowel or ileal conduit, the pressure gradient providing closure of the bowel or ileal conduit

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

a longitudinal portion which encircles the bowel or ileal conduit and holds the waste matter

Methodology Applied

Scientific EffectPhysical containment: Physical Containment

Data Source

PatentUS8900116B2Inflatable stomal implant

Publication Date: 2014.12.02 B BRAUN MEDICAL SAS

AI summary

A stomal implant comprising a longitudinal portion configured to envelop at least a section of the bowel or ileal conduit, said longitudinal portion comprising: a proximal end for positioning at a stomal opening; a distal end for positioning within an abdomen; and a reversibly pressure-exerting device providing an ascending pressure gradient from the distal end to the proximal end, such that pressure exerted at the proximal end provides complete closure of the bowel or urethra.