Gastrointestinal Tissue Fold Formation for Durable Anchor Placement

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Solution Overview

Problem

In minimally invasive gastrointestinal surgery, particularly for morbidly obese patients, accessing and approximating the muscularis and serosa layers of the gastrointestinal tract is challenging due to excess fat layers, making it difficult to perform durable tissue approximation and anchor placement without injuring adjacent tissues or organs.

Innovation Solution

A method and apparatus involving a delivery catheter with flexible tubes and a tissue grabbing assembly to create a gastrointestinal tissue fold, allowing an anchor assembly to be deployed across the muscularis and serosa layers, ensuring durable plication and reducing the risk of neighboring organ injury.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If endoluminal approach is used to access GI tract, then minimally invasive surgery is achieved, but muscularis and serosa layers are difficult to access and approximate

Engineering Contradiction:

Improveminimally invasive accessVSAvoidtissue approximation durability

Core Design Contradiction:

Ease of operationVSEase of manufacture

Solution Approach 1:

The delivery catheter is used to create a tissue fold by manipulating the mucosa and connective tissue layers before anchor placement. This preliminary folding action brings the serosa layer into position where it can be reliably approximated and anchored, solving the problem of accessing deep layers through the mucosa.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The delivery catheter acts as an intermediary tool that extends through the mucosa and connective tissue layers to reach and manipulate the serosa layer. By using the catheter as a mediator, the system can access and approximate the serosa layer without requiring direct visual or manual access through the mucosa.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If serosa to serosa approximation is created, then durable tissue approximation is achieved, but risk of injuring adjacent organs increases

Engineering Contradiction:

Improvetissue approximation durabilityVSAvoidadjacent organ injury risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system incorporates visual feedback through the delivery catheter, allowing the operator to observe the position of the tissue fold and the proximity to adjacent organs in real-time. This feedback mechanism enables careful adjustment of the folding and anchor placement to achieve serosa-to-serosa approximation while avoiding injury to neighboring structures.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The tissue fold is created as a preliminary action that pre-positiones the serosa layer in a controlled manner before anchor placement. This preliminary folding action establishes a safe pathway and orientation that reduces the risk of inadvertently puncturing or injuring adjacent organs during the subsequent anchor deployment.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If standard laparoscopic trocars are used in morbidly obese patients, then surgical access is attempted, but inadequate length and fat layers make access difficult

Engineering Contradiction:

Improvesurgical accessVSAvoidtrocars length

Core Design Contradiction:

Ease of operationVSLength of stationary object

Solution Approach 1:

Instead of approaching the GI tract from the external surface through the abdominal wall (standard laparoscopic approach), the system inverts the approach by entering through the natural lumen of the GI tract itself. This internal approach bypasses the problem of inadequate trocar length and the difficulty of penetrating thick fat layers, as the delivery catheter is pushed through the mucosa from the inside.

Inventive Principle:

Principle #13The other way round (Inversion)

Data Source

PatentUS7618426B2Apparatus and methods for forming gastrointestinal tissue approximations

Publication Date: 2009.11.17 USGI MEDICAL INC

AI summary

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point.