Gastrointestinal Tissue Expansion Device with Parallel Fluid Delivery

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Solution Overview

Problem

Current devices and methods for expanding submucosal and other tissue layers in gastrointestinal endoscopy are cumbersome, inaccurate, and limited in their ability to achieve large expansion areas, leading to prolonged procedure times.

Innovation Solution

A tissue expansion device with multiple fluid delivery elements, including needles or water jets, configured to perform near full circumferential expansion of luminal wall tissue, allowing for precise control of fluid delivery and tissue manipulation, including vacuum-assisted tissue positioning and pressure-controlled fluid injection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If traditional injection catheters are used to deliver fluid beneath the submucosa, then tissue expansion can be achieved, but the procedure becomes cumbersome and time-consuming with limited expansion area

Engineering Contradiction:
Improvetissue expansion areaVSAvoidprocedure time
Core Design Contradiction:
Area of stationary objectVSProductivity

Solution Approach 1:

The device divides the single catheter into multiple separate injection catheters (first injection catheter, second injection catheter, etc.), each capable of delivering fluid to different locations simultaneously. This segmentation allows for larger tissue expansion area while maintaining efficient procedure time by enabling parallel fluid delivery to multiple submucosal locations.

Inventive Principle:
Principle #1Segmentation

2Area of stationary object

If multiple injection catheters are used to expand larger tissue areas, then expansion coverage improves, but device complexity increases

Engineering Contradiction:
Improvetissue expansion areaVSAvoiddevice structure
Core Design Contradiction:
Area of stationary objectVSDevice complexity

Solution Approach 1:

The device merges multiple injection catheters into a single integrated tissue expansion device that includes a support structure holding multiple catheters. The catheters are positioned at different locations on the support structure, allowing them to work together as a unified system for expanding large tissue areas while maintaining manageable device complexity through organized integration.

Inventive Principle:
Principle #5Merging (Combining)

3Manufacturing precision

If fluid is delivered to expand submucosal tissue, then tissue elevation is achieved, but precise control of fluid delivery and tissue positioning is difficult

Engineering Contradiction:
Improvetissue expansion precisionVSAvoidfluid delivery control
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The device incorporates a suction catheter that works in conjunction with the injection catheters to provide feedback control. The suction catheter can remove excess fluid and allow the operator to monitor tissue expansion in real-time, enabling precise control of fluid delivery and tissue positioning by adjusting injection and suction rates based on observed tissue response.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The support structure acts as an intermediary between the operator and the tissue expansion process. It holds the injection catheters in predetermined positions and orientations, providing mechanical guidance that ensures accurate fluid delivery to specific submucosal locations while simplifying operator manipulation during the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 enables efficient, accurate, and rapid expansion of gastrointestinal tissue layers, reducing procedure time and improving the effectiveness of subsequent treatments by providing a safety volume for tissue protection and enhanced visualization.

Implementation Method 1

a vacuum port configured to apply a force to tissue

Methodology Applied
Scientific EffectVacuum: Vacuum

Implementation Method 2

pressure-controlled delivery of fluid into tissue

Methodology Applied
Scientific EffectFluid injection under pressure: Pressurisation

Data Source

PatentUS20250228608A1Tissue expansion devices, systems and methods
Publication Date: 2025.07.17 FRACTYL HEALTH INC
  • US20250228608A1 patent drawing
  • US20250228608A1 patent drawing
  • US20250228608A1 patent drawing

AI summary

A device for expanding tissue comprises at least one fluid delivery tube and at least one fluid delivery element in fluid communication with the at least one fluid delivery tube. The at least one fluid delivery tube comprises a proximal end, a distal end, and a lumen therebetween. The device is constructed and arranged to perform a near full circumferential expansion of luminal wall tissue. Systems and methods are also provided, including a system for expanding tissue layers and treating tissue proximate to the expanded tissue layers.