Crosslinked Submucosal Gel Cushion for GI Lesion Resection

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Solution Overview

Problem

Existing methods for treating gastrointestinal lesions and procedures face challenges in safely removing mucosal and submucosal layers without causing bleeding, perforation, or exposure to harmful gastrointestinal contents, and require effective protection for the underlying tissue to prevent complications such as bleeding, ulcer formation, and delayed healing.

Innovation Solution

A crosslinkable gel and crosslinker system is used to increase the volume of a tissue layer, allowing safe resection of a portion of that layer while providing a protective covering that remains at the site to prevent further injury and promote healing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If mucosal and submucosal layers are removed to treat gastrointestinal lesions, then the lesion can be resected, but bleeding and perforation of underlying layers may occur

Engineering Contradiction:

Improvelesion resectionVSAvoidrisk of bleeding and perforation

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

A protective barrier is applied to the underlying tissue before resection begins. This preliminary protective action ensures that even if the resection depth exceeds expectations, the underlying muscle layer remains protected from bleeding and perforation complications

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The protective barrier acts as a cushioning layer between the resection site and the underlying muscle layer. This beforehand cushioning prevents direct contact between harsh resection instruments/agents and the vulnerable underlying tissue, reducing the risk of accidental damage

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Productivity

If mucosal layer is removed to access underlying tissue, then the lesion becomes accessible, but the underlying tissue is exposed to harmful gastrointestinal contents

Engineering Contradiction:

Improvetissue accessibilityVSAvoidexposure to stomach acid and digestive enzymes

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

A protective barrier is introduced as an intermediary layer between the harmful gastrointestinal contents and the exposed underlying tissue. This mediator prevents direct contact between stomach acid, digestive enzymes, and the vulnerable tissue, allowing healing to proceed without chemical damage

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The protective barrier creates an inert protective environment over the exposed tissue. This barrier isolates the underlying tissue from the harsh gastrointestinal environment, preventing harmful factors from damaging the healing tissue while allowing the lesion to be treated

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

3Reliability

If a protective covering is applied to protect exposed tissue, then healing is protected from bacteria and food, but the device complexity increases

Engineering Contradiction:

Improveprotection from infection and inflammationVSAvoidprotective covering system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The protective barrier undergoes a phase change from liquid to gel form after application. This parameter change allows the material to be easily administered as a liquid that can flow and conform to the tissue surface, then transforms into a stable gel that provides durable protection without requiring complex application devices

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The protective barrier utilizes a liquid-to-gel phase transition to simplify the system. The liquid form enables easy delivery through simple application methods, while the gel form provides the necessary structural integrity and protective functions, eliminating the need for complex delivery mechanisms

Inventive Principle:

Principle #36Phase transitions

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 minimizes bleeding and perforation risks, protects the exposed tissue from gastrointestinal contents, and accelerates healing by forming a durable protective layer that remains in place for at least 24-72 hours, reducing post-procedure complications.

Implementation Method 1

injecting a crosslinkable gel into a first tissue layer... providing a crosslinker... so that the crosslinkable gel and the crosslinker form a crosslinked gel

Methodology Applied

Scientific EffectCrosslinking: Chemical Bonding

Data Source

PatentUS12485204B2Crosslinking submucosal injectate system

Publication Date: 2025.12.02 COOK MEDICAL TECHNOLOGIES LLC

AI summary

A method of treating a lesion in a gastrointestinal tract and an injectate system are provided. The method includes injecting a crosslinkable gel into a first tissue layer, the crosslinkable gel increasing a volume of the first tissue layer. The method also includes providing a crosslinker and resecting a portion of a first tissue layer having the increased volume away from a second tissue layer creating an exposed region in a remaining portion of the first layer and leaving a portion of the gel covering at least a portion of the exposed region. The injectate system includes a crosslinkable gel and a crosslinker where the crosslinkable gel and the crosslinker form a crosslinked gel having a compressive modulus of about 10-500 kPa.