Tissue Acquisition Device with Slit Sleeve for Fold Integrity

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Solution Overview

Problem

Existing devices for forming tissue folds in the stomach often draw in more than two layers of tissue or staple the flexible-membrane sleeve to the fold, leading to complications during the tissue uptake process.

Innovation Solution

A device with a flexible-membrane sleeve featuring an elongate slit with a gap dimensioned to restrict additional tissue layers, once two layers are drawn in, and a vacuum reservoir for controlled vacuum application, ensuring the layers remain in contact and preventing secondary layers from entering the chamber.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a vacuum is applied to the tissue chamber to draw tissue into the chamber, then tissue uptake is achieved, but more than two layers of tissue may be drawn into the chamber and the flexible-membrane sleeve may be drawn into the chamber

Engineering Contradiction:
Improvetissue layers drawn into chamberVSAvoidtissue fold integrity
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The opening in the flexible-membrane sleeve is configured with specific dimensional characteristics (elongate shape with controlled dimensions) that create different functional zones: the opening allows passage of tissue layers while its specific geometry prevents the sleeve membrane itself from being drawn into the chamber. This local structural quality distinction enables selective tissue uptake while maintaining reliability.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent controls the physical parameters of the opening (its size, shape, and configuration) to achieve the desired effect. By carefully dimensioning the opening parameters, the system allows sufficient tissue layers to be drawn in while preventing excessive tissue or sleeve material from entering the chamber, thus resolving the contradiction between quantity control and reliability.

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If the opening in the flexible-membrane sleeve is made larger to allow adequate tissue uptake, then tissue acquisition is improved, but additional tissue layers beyond two may be drawn into the chamber

Engineering Contradiction:
Improvetissue acquiredVSAvoidtissue fold layer control
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The opening is designed with specific local dimensional characteristics that differentiate its function: it is sized and shaped to permit adequate tissue acquisition while its particular geometry (elongate form with controlled dimensions) creates a natural barrier that prevents more than two tissue layers from being drawn in. This local structural quality enables both adequate quantity and precise layer control.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The flexible-membrane sleeve with its specifically dimensioned opening exhibits dynamic behavior during vacuum application. The opening maintains its dimensional integrity under vacuum conditions, allowing tissue to pass through while the membrane's flexibility and opening geometry work together to prevent excessive tissue layers from entering, thus achieving both adequate acquisition and precise layer control.

Inventive Principle:
Principle #15Dynamics

3Manufacturing precision

If the opening in the flexible-membrane sleeve is made smaller to restrict additional tissue layers, then layer control is improved, but tissue acquisition may be insufficient

Engineering Contradiction:
Improvetissue fold layer controlVSAvoidtissue acquired
Core Design Contradiction:
Manufacturing precisionVSQuantity of substance

Solution Approach 1:

The opening parameters (dimensions, shape, orientation) are optimized to achieve the balance between precision and quantity. The elongate configuration with specific dimensional ratios allows sufficient tissue surface area to be captured while the controlled opening size naturally limits the number of tissue layers that can pass through, resolving the contradiction between adequate acquisition and precise layer control.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The opening is configured as an elongate structure rather than a simple circular or square aperture. This dimensional change from a compact shape to an elongate form increases the effective opening area for tissue acquisition while the specific elongate geometry maintains control over the number of tissue layers, enabling both adequate quantity and precision.

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

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 solution effectively restricts the intake of additional tissue layers, maintaining the integrity of the tissue fold and reducing complications during the plication process, allowing for precise and safe formation of stomach tissue folds.

Implementation Method 1

upon the application of a vacuum to the chamber when the sleeve opening is placed against tissue

Methodology Applied
Scientific EffectVacuum: Vacuum

Implementation Method 2

drawn into the tissue chamber through the slit

Methodology Applied
Scientific EffectPressure difference: Pressure Gradient

Data Source

PatentEP2804539B1Tissue-acquisition device
Publication Date: 2019.05.22 BOSTON SCIENTIFIC SCIMED INC
  • EP2804539B1 patent drawingFigure 1A~1B
  • EP2804539B1 patent drawingFigure 2
  • EP2804539B1 patent drawingFigure 3A~3C

AI summary

Described herein is an improved device and method for acquiring, and optionally, fastening a tissue fold. The device has an improved configuration for forming a single, two-layer tissue fold.