Gastrointestinal Prosthesis Adhesive and Porous Layer Anchoring

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Solution Overview

Problem

Existing medical devices implanted in the gastrointestinal tract face challenges such as migration due to the mucosal layer renewal, peristaltic motion, and degradation by digestive enzymes, making long-term anchoring difficult.

Innovation Solution

A prosthesis with a liquid-impermeable material layer, a porous layer for tissue ingrowth, and an adhesive portion to secure the device to the site for at least 24 hours, combining with a body that can expand and provide radial force for fixation, using materials like metals, polymers, and biodegradable materials.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a device is attached to the mucosal layer of the GI tract, then short-term anchoring is achieved, but long-term anchoring is limited due to mucosal layer renewal

Engineering Contradiction:
Improveanchoring durationVSAvoidattachment reliability
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The prosthesis incorporates multiple anchoring mechanisms operating at different time scales: an adhesive portion for immediate short-term attachment to the mucosal layer, and a porous layer for long-term tissue ingrowth and anchoring. This segmentation of anchoring functions resolves the contradiction between short-term and long-term attachment reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The adhesive portion provides preliminary anchoring action immediately upon implantation, securing the device to the mucosal layer before tissue ingrowth occurs. This preliminary action ensures the device remains in position during the critical initial period while the body begins the tissue integration process.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If a device is attached to the GI tract wall, then the device is secured against migration, but the adhesive must remain effective in the presence of digestive enzymes and peristaltic motion

Engineering Contradiction:
Improveattachment reliabilityVSAvoidenzyme degradation and peristalsis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The porous layer serves as an intermediary between the adhesive portion and the GI tract environment. It protects the adhesive from direct exposure to digestive enzymes and mechanical stress from peristalsis, while still allowing tissue ingrowth to provide long-term anchoring. This intermediary structure shields the adhesive mechanism from harmful environmental factors.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The prosthesis uses a composite structure combining an adhesive portion with a porous layer made of biocompatible materials. This composite design integrates materials with different functions: the adhesive provides initial attachment, while the porous layer provides structural support, protection, and tissue integration capabilities, collectively resisting enzyme degradation and peristaltic forces.

Inventive Principle:
Principle #40Composite materials

3Duration of action of stationary object

If a porous layer is added for tissue ingrowth, then long-term anchoring is improved, but the device structure becomes more complex

Engineering Contradiction:
Improvelong-term anchoringVSAvoidstructure complexity
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The porous layer is merged with the adhesive portion into a single integrated component rather than separate parts. This merging combines the anchoring functions (adhesive attachment and tissue ingrowth) into one unified structure, reducing overall device complexity while achieving both short-term and long-term anchoring capabilities.

Inventive Principle:
Principle #5Merging (Combining)

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 prosthesis effectively inhibits migration by securing the device to the GI tract for both short-term and long-term use, allowing tissue ingrowth to anchor the device, thus preventing displacement and degradation.

Implementation Method 1

an adhesive portion provided on the porous material layer adapted to secure the material portion to a site

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

a porous material layer having a pore size adapted for promoting tissue ingrowth

Methodology Applied
Scientific EffectTissue ingrowth: Porosity

Data Source

PatentEP3166535B1Migration-resistant gastrointestinal barrier with adhesive portion
Publication Date: 2021.01.13 COOK MEDICAL TECHNOLOGIES LLC
  • EP3166535B1 patent drawingFigure 1~5
  • EP3166535B1 patent drawingFigure 3~7
  • EP3166535B1 patent drawingFigure 8~11

AI summary

A prosthesis and a method for securing a prosthesis at a treatment site are provided. The prosthesis includes a material portion. The material portion includes a liquid-impermeable material layer (22), a porous material layer (28) having a pore size adapted for promoting tissue ingrowth, and an adhesive portion (60) provided on the porous material layer adapted to secure the material portion to a site for at least 24 hours following implantation of the prosthesis at the site. In some embodiments, the prosthesis further includes a body (18).