Injectate Delivery Device With Vacuum-Assisted Radial Expansion

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Solution Overview

Problem

Current devices for expanding submucosal and other tissue layers in gastrointestinal endoscopy are cumbersome, inaccurate, and have limited effective tissue area, necessitating improved methods for simplified use, larger expansion areas, and reduced procedure time.

Innovation Solution

An injectate delivery device with advanced controls for fluid delivery and tissue manipulation, including vacuum assistance, radially expandable elements, and sensors for precise injectate delivery and tissue expansion, allowing for controlled expansion of tissue layers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If traditional injection catheters are used to deliver fluid within the submucosal layer, then tissue expansion can be achieved, but the devices are cumbersome and have limited effective tissue area

Engineering Contradiction:
Improveeffective tissue areaVSAvoiddevice complexity
Core Design Contradiction:
Area of stationary objectVSDevice complexity

Solution Approach 1:

The device divides the tissue expansion function into multiple fluid delivery elements (needles) that can be independently controlled. Each needle can be advanced to a different extent and deliver fluid to different locations, allowing coverage of larger tissue areas while keeping each individual needle simple in structure

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device transitions from a single-point injection approach to a multi-dimensional expansion capability by arranging multiple fluid delivery elements in different spatial orientations and depths, enabling three-dimensional tissue expansion coverage without requiring a single complex device structure

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

2Productivity

If traditional injection methods are used to elevate and expand submucosa, then tissue geometry can be changed, but procedure time is increased

Engineering Contradiction:
Improveprocedure timeVSAvoidprocedure time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The device performs preliminary actions by pre-positioning multiple fluid delivery elements within the tissue and establishing fluid delivery pathways before the actual expansion procedure, allowing for faster tissue elevation and expansion without requiring repeated insertions or adjustments during the procedure

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device enables continuous fluid delivery through multiple needles simultaneously, maintaining constant tissue expansion pressure and eliminating interruptions that would occur with sequential single-needle injection methods, thereby reducing overall procedure time

Inventive Principle:
Principle #20Continuity of useful action

3Measurement precision

If traditional injection catheters are used to deliver injectate, then tissue can be elevated, but accuracy of delivery is limited

Engineering Contradiction:
ImprovedeliverY precisionVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The device incorporates sensors that provide real-time feedback on tissue characteristics, fluid delivery rates, and needle positions, allowing the operator to adjust delivery parameters to achieve precise tissue elevation and expansion while maintaining ease of operation through automated control assistance

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The device replaces manual mechanical injection control with automated fluid delivery systems that use electronic control and sensing to precisely regulate injectate flow rates, pressures, and volumes, achieving accurate tissue delivery while simplifying operator interaction

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 and accurate expansion of tissue layers, providing larger effective areas with reduced procedure time and improved precision, facilitating better therapeutic outcomes in gastrointestinal procedures.

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

PatentEP3122413B1Injectate delivery devices
Publication Date: 2021.10.20 FRACTYL HEALTH INC
  • EP3122413B1 patent drawingFigure 1~1A
  • EP3122413B1 patent drawingFigure 2A~2C
  • EP3122413B1 patent drawingFigure 3

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.