Internal Stoma Device with Expandable Nitinol Stent

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Solution Overview

Problem

Conventional stoma procedures for intestinal surgery pose challenges in controlling intestinal content flow, risk of infection, skin irritation, and complications like stenosis and prolapse, due to externalization of the intestine and difficulties in attaching ostomy appliances.

Innovation Solution

A device with a self-expandable nitinol stent for placement within the intestine to capture and divert contents, featuring a distal portion extending through the abdominal wall for content drainage, optionally with a valve for continence and adjustable length, designed to eliminate the need for externalizing the intestine and reduce complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the intestine is externalized through the abdominal wall to form a stoma, then waste elimination is enabled, but the risk of infection and skin irritation increases

Engineering Contradiction:
Improvewaste elimination functionVSAvoidinfection and skin irritation risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary device consisting of a proximal portion within the intestine and a distal portion extending through the abdominal wall. This intermediary structure allows waste elimination while preventing direct contact between intestinal contents and the external environment, thereby reducing infection and skin irritation risks associated with conventional externalized stomas.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the intestine is externalized to form a stoma, then waste elimination is enabled, but control over intestinal content flow is difficult

Engineering Contradiction:
Improvewaste elimination functionVSAvoidcontrol over intestinal content flow
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent incorporates a valve mechanism in the distal portion that can be dynamically adjusted to control the flow of intestinal contents. This dynamic control allows regulation of content discharge timing and rate, addressing the inability to control flow in conventional externalized stomas while maintaining the waste elimination function.

Inventive Principle:
Principle #15Dynamics

3Reliability

If a conventional stoma is created, then waste elimination is achieved, but attachment of ostomy appliances is difficult

Engineering Contradiction:
Improvewaste elimination functionVSAvoidattachment of ostomy appliances
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent merges the ostomy appliance attachment function directly into the distal portion of the device. The distal portion is designed with integrated attachment features that facilitate secure connection to collection bags or other receiving means, eliminating the difficulty of separate appliance attachment associated with conventional stomas while preserving waste elimination capability.

Inventive Principle:
Principle #5Merging (Combining)

4Reliability

If the proximal portion is made expandable to engage the intestine wall, then secure positioning is achieved, but device complexity increases

Engineering Contradiction:
Improvesecure positioning in intestineVSAvoidexpandable structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent utilizes parameter changes in the form of an expandable proximal portion that transitions from a compressed insertion state to an expanded deployment state. This parameter change allows the device to be inserted through a small opening and then expanded to engage the intestine wall securely, achieving reliable positioning without requiring a complex pre-expanded structure that would be difficult to implant.

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 device effectively manages intestinal content flow, reduces infection risk, and minimizes complications by internal diversion and controlled drainage, providing a flexible, kink-resistant, and compressible solution for intestinal content management.

Implementation Method 1

a self-expandable nitinol stent for placement within the intestine

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 2

The device may be flexible, crush resistant, and kink resistant

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS10980663B2Medical device for use with a stoma
Publication Date: 2021.04.20 WL GORE & ASSOC INC
  • US10980663B2 patent drawing
  • US10980663B2 patent drawing
  • US10980663B2 patent drawing

AI summary

An device including a proximal portion adapted for placement intermediately within a hollow body cavity to capture and divert contents; the proximal portion being expandable from an initial state with an initial diameter, into an expanded state with a diameter greater than the initial diameter for engaging the proximal portion with an inner wall of the hollow body cavity; and a distal portion, connected to the proximal portion, adapted to extend through the abdominal wall or into the intestine to conduct the hollow body cavity contents out of the proximal portion.