Shape Memory Clips for Tissue Opening Reduction

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Solution Overview

Problem

Post-surgical leaks, such as those occurring after sleeve gastrectomy, pose significant complications, including sepsis and high treatment costs, and often cannot be addressed with additional invasive procedures due to compromised immune systems or other risks.

Innovation Solution

Implantable shape memory clips with preformed bends and protrusions are used to reduce the dimension of tissue openings, configured to transform from a compressed to an expanded state for minimally invasive deployment, securing tissue portions and reducing opening dimensions in staple lines or other tissue defects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If additional invasive procedures are performed to address post-surgical leaks, then treatment effectiveness may improve, but patient risk and complexity increase

Engineering Contradiction:
Improveleak treatment effectivenessVSAvoidprocedure invasiveness
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The clip is designed to be self-deploying through shape memory material that automatically transforms from a compressed delivery configuration to an expanded closed configuration once released from the delivery device, eliminating the need for additional manual manipulation or complex deployment mechanisms

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The clip can be delivered through a catheter or other delivery device and deployed by extracting it from the confined delivery space, allowing the clip to transform and secure tissue without requiring additional invasive surgical procedures

Inventive Principle:
Principle #2Taking out (Extraction)

2Device complexity

If shape memory material is used to enable minimally invasive deployment, then procedure complexity reduces, but manufacturing precision requirements increase

Engineering Contradiction:
Improvedeployment procedure complexityVSAvoidpreformed bend configuration precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The clip is pre-formed with specific bend configurations during manufacturing that enable automatic transformation upon deployment, with preformed bends positioned to radially outward progression from the delivery device to ensure proper tissue engagement

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The shape memory material undergoes parameter changes in temperature or stress state to trigger transformation from compressed to expanded configuration, allowing precise control of deployment timing and position without complex mechanical mechanisms

Inventive Principle:
Principle #35Parameter changes

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 clips effectively reduce tissue opening dimensions, providing a minimally invasive solution to address leaks and other tissue defects, enhancing patient safety and reducing treatment costs by avoiding additional invasive procedures.

Implementation Method 1

the clip may include a shape memory material; the clip may be configured to transform from a compressed configuration to an expanded configuration

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS11607207B2Devices and methods for reducing a dimension of openings in tissue
Publication Date: 2023.03.21 BOSTON SCIENTIFIC SCIMED INC
  • US11607207B2 patent drawing
  • US11607207B2 patent drawing
  • US11607207B2 patent drawing

AI summary

A clip for reducing a dimension of an opening in tissue may include a continuous member having a plurality of legs and a plurality of preformed bends connecting adjacent legs, wherein the plurality of legs form: a first group having two protrusions; a second group having two protrusions; and a third group having two protrusions, wherein each protrusion of each group includes two legs of the continuous member and a corresponding preformed bend connecting the two legs, and each protrusion of each group extends from a region adjacent a first end of the clip to a region adjacent a second end of the clip.