Vacuum-Assisted Injectate Delivery for Precise Submucosal Expansion

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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 have limited effectiveness in terms of expansion area and procedure time.

Innovation Solution

An injectate delivery device with advanced controls for fluid delivery, vacuum manipulation, and tissue expansion, featuring multiple fluid delivery elements, sensors, and a handle with user interface for precise control of injectate flow, expansion, and tissue manipulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If current devices and methods are used for expanding submucosal tissue layers, then the procedure can be performed with existing technology, but the devices are cumbersome and the procedure time is extended

Engineering Contradiction:
Improveease of useVSAvoidprocedure time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The device divides the tissue expansion function into multiple independent fluid delivery elements (needles or jets) that can be selectively activated. Each element can deliver injectate independently, allowing the operator to treat different areas simultaneously or sequentially, reducing overall procedure time while maintaining ease of operation through modular control.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device integrates multiple functions into a single platform: fluid delivery for tissue expansion, vacuum control for tissue manipulation, and coordinated operation capabilities. This multi-functional design eliminates the need for multiple separate devices and procedures, reducing procedure time while providing comprehensive tissue treatment capabilities.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Area of stationary object

If current injection catheters are used to deliver fluid throughout the target area, then the submucosa can be elevated, but the affected tissue area is limited

Engineering Contradiction:
Improveexpansion areaVSAvoiddevice complexity
Core Design Contradiction:
Area of stationary objectVSDevice complexity

Solution Approach 1:

The device employs multiple fluid delivery elements distributed across the treatment area, each capable of delivering injectate to specific zones. This segmented approach allows coverage of a larger overall tissue area compared to a single catheter, while the modular nature of the elements keeps the device design manageable and not excessively complex.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The fluid delivery elements can be positioned and oriented in different spatial dimensions and angles, allowing injectate to be delivered throughout a three-dimensional volume of tissue rather than along a single linear path. This dimensional expansion significantly increases the affected tissue area while maintaining a relatively simple device structure.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Measurement precision

If manual tissue manipulation is performed during injectate delivery, then tissue can be elevated, but the process is inaccurate and cumbersome

Engineering Contradiction:
ImproveaccuracyVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The device combines fluid delivery, vacuum manipulation, and tissue expansion functions into a single integrated system with coordinated controls. This merging of functions allows precise control of tissue manipulation and injectate delivery simultaneously, improving accuracy while maintaining ease of operation through unified control mechanisms rather than requiring separate manual operations.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device incorporates sensors and controls that provide feedback on tissue response and fluid delivery parameters. This feedback mechanism allows the system to automatically adjust delivery rates, vacuum levels, and element positioning to achieve precise tissue expansion and manipulation, improving accuracy while reducing the manual dexterity required from the operator.

Inventive Principle:
Principle #23Feedback

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 provides simplified, accurate, and efficient tissue expansion with larger expansion areas and reduced procedure time, enabling improved therapeutic interventions in gastrointestinal tissue.

Implementation Method 1

activate a supply of vacuum constructed and arranged to move tissue toward the at least one fluid delivery element

Methodology Applied
Scientific EffectVacuum: Vacuum

Data Source

PatentUS12478426B2Injectate delivery devices, systems and methods
Publication Date: 2025.11.25 FRACTYL HEALTH INC
  • US12478426B2 patent drawing
  • US12478426B2 patent drawing
  • US12478426B2 patent drawing

AI summary

An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided.