Submucosal Injection Sequence for Stable GI Lesion Elevation

Solution Overview

Problem

Existing endoscopic procedures face challenges in separating and elevating the submucosal layer from the muscularis layer within the gastrointestinal tract for efficient resection, as low viscosity fluids dissipate quickly and high viscosity fluids require high injection forces that can damage tissues.

Innovation Solution

A system using a delivery device with a low viscosity injectable composition to separate and a high viscosity injectable composition to elevate the submucosal layer, where the viscosity difference is at least ten times greater, and a barrier member to prevent mixing, allowing for precise tissue separation and stabilization without tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If low viscosity fluid is injected between tissue layers, then the fluid can flow between layers to separate tissue, but the fluid dissipates quickly and cannot maintain elevation

Engineering Contradiction:

Improvefluid flow between tissue layersVSAvoidduration of tissue elevation

Core Design Contradiction:

Ease of operationVSDuration of action of moving object

Solution Approach 1:

The injection system is divided into multiple chambers: a first chamber containing low viscosity fluid for initial tissue separation, and a second chamber containing high viscosity fluid for sustained elevation. This segmentation allows each fluid to perform its specific function optimally without mixing.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The low viscosity fluid is injected first to create initial separation between tissue layers, preparing the space for subsequent high viscosity fluid injection. This preliminary action enables the high viscosity fluid to be properly positioned for sustained elevation without requiring excessive injection force.

Inventive Principle:

Principle #10Preliminary action

2Duration of action of moving object

If high viscosity fluid is injected to elevate and stabilize tissue, then tissue elevation is maintained, but high injection forces damage or perforate tissue layers

Engineering Contradiction:

Improveduration of tissue elevationVSAvoidtissue damage from injection force

Core Design Contradiction:

Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The injection system is divided into multiple chambers: a first chamber containing low viscosity fluid for initial tissue separation, and a second chamber containing high viscosity fluid for sustained elevation. This segmentation allows each fluid to perform its specific function optimally without mixing.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The low viscosity fluid is injected first to create initial separation between tissue layers, preparing the space for subsequent high viscosity fluid injection. This preliminary action enables the high viscosity fluid to be properly positioned for sustained elevation without requiring excessive injection force.

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If single viscosity fluid is used for both separation and elevation, then device complexity is reduced, but cannot achieve both effective separation and sustained elevation

Engineering Contradiction:

Improvenumber of injectable compositionsVSAvoideffectiveness of tissue separation and elevation

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The injection system is divided into multiple chambers: a first chamber containing low viscosity fluid for initial tissue separation, and a second chamber containing high viscosity fluid for sustained elevation. This segmentation allows each fluid to perform its specific function optimally without mixing.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different viscosity characteristics are applied to different functional requirements: low viscosity fluid is used where flow and penetration are needed (initial separation), while high viscosity fluid is used where stability and elevation maintenance are needed (sustained elevation).

Inventive Principle:

Principle #3Local quality

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

Enables efficient and safe visualization and resection of lesions by maintaining tissue elevation and minimizing tissue trauma, allowing for precise resection with reduced risk of perforation.

Implementation Method 1

A viscosity of the first injectable composition may be less than a viscosity of the second injectable composition

Methodology Applied

Scientific EffectViscosity:

Implementation Method 2

a viscosity of the second injectable composition may be at least ten times greater than the viscosity of the first injectable composition

Methodology Applied

Scientific EffectViscosity:

Implementation Method 3

The first and second injectable compositions may be separated by a barrier member. The barrier member may be configured to rupture above a threshold level of force.

Methodology Applied

Scientific EffectPhysical barrier separation:

Data Source

PatentEP3624712B1Systems for submucosal tissue separation

Publication Date: 2024.11.27 BOSTON SCIENTIFIC SCIMED INC

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Figure 2A
Figure 2B~2C

AI summary

The present disclosure relates to the field of medical devices generally and specifically, to endoscopic systems and methods for resection of malignant and pre-malignant lesions within the gastrointestinal (GI) tract. In particular, the present disclosure relates to systems and methods for delivering injectable compositions between tissue layers (e.g., between the muscularis and submucosa layers) to elevate and stabilize the lesion for fast and efficient resection.