Self-Closing Clips with Shape Memory Alloy for Tissue Closure

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Solution Overview

Problem

Conventional methods for closing internal bodily openings, such as trans-apical heart wall access openings, are inefficient and risky, especially in minimally invasive procedures, as manual suturing is time-consuming and may not ensure complete closure.

Innovation Solution

A system comprising self-closing clips connected by a flexible tether, where the clips are deployed around the opening and drawn together by pulling the tether to effect closure, utilizing shape memory alloy for automatic self-reversion and piercing ends for secure attachment to tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual suturing is used to close internal tissue openings, then closure can be achieved, but the procedure becomes time-consuming and difficult

Engineering Contradiction:
Improveclosure effectivenessVSAvoidprocedural time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The closure system is divided into multiple independent self-closing clips distributed around the opening perimeter. Each clip independently engages tissue at its location, and the collective action of all clips achieves complete closure without requiring manual suturing. This segmentation allows parallel processing of closure at multiple points simultaneously, dramatically reducing procedural time while maintaining reliable closure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Each self-closing clip is designed to automatically engage and secure tissue without manual intervention. The clips utilize shape memory alloy to self-revert to a closed configuration that grinds tissue together, eliminating the need for surgeons to manually sew sutures. This self-service mechanism reduces both procedural time and the skill requirement while ensuring consistent closure effectiveness.

Inventive Principle:
Principle #25Self-service

2Reliability

If a plug is inserted into the heart wall opening, then closure may be achieved, but complete closure is difficult and additional procedures are required

Engineering Contradiction:
Improveclosure completenessVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Instead of using a single plug that requires additional securing procedures, the system employs multiple self-closing clips distributed around the opening perimeter. Each clip independently secures tissue at its location, and together they provide complete closure. This segmentation eliminates the need for additional procedures to secure a single plug, reducing overall procedure complexity while ensuring reliable closure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system replaces the mechanical plug insertion and securing mechanism with a distributed system of self-closing clips that automatically engage tissue. The clips utilize shape memory alloy to self-revert to a closed configuration that grinds tissue together, eliminating the need for additional manual securing procedures. This substitution reduces procedure complexity while maintaining closure completeness.

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

3Productivity

If conventional suture techniques are used, then closure can be effected, but the process is manual and time-consuming

Engineering Contradiction:
Improveclosure speedVSAvoidoperational simplicity
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The self-closing clips are designed to automatically engage and secure tissue without requiring manual suturing. The shape memory alloy causes the clips to self-revert to a closed configuration that grinds tissue together, eliminating the need for surgeons to manually manipulate sutures. This self-service mechanism dramatically increases closure speed and simplifies operation.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system replaces the manual mechanical suture tying process with automated self-closing clips that utilize shape memory alloy. The clips automatically engage tissue and self-revert to a closed configuration through material properties, eliminating the need for manual manipulation. This substitution dramatically increases closure speed and operational simplicity.

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

This method provides a rapid, effective, and secure closure of internal bodily openings, reducing procedural time and risk, and is adaptable for various minimally invasive surgical contexts, including cardiac and other tissue repairs.

Implementation Method 1

The self-closing clips may be formed from any suitable material, and in some embodiments are formed from shape memory alloy. The self-closing clips are transitionable from a natural or undeformed state to a biased or deflected state, and then self-revert back to the natural or undeformed state.

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentEP3689261B1System for closure of an internal opening in tissue, such as a trans-apical access opening
Publication Date: 2024.05.29 MEDTRONIC INC
  • EP3689261B1 patent drawingFigure 1
  • EP3689261B1 patent drawingFigure 2A~2B
  • EP3689261B1 patent drawingFigure 3A~3B

AI summary

A method for closing an opening at a target site including bodily tissue including embedding a plurality of self-closing clips (30) into the target site in a spaced apart manner about a perimeter of the opening. Each of the clips has opposing clip ends (52, 54) and an intermediate segment (50). A flexible tether (24) is coupled to the embedded clips to form a loop about the opening perimeter. A pulling force is applied onto at least one of the loop ends, thereby drawing the perimeter of the opening onto itself to completely close the opening. The loop ends are secured to maintain the target site in a closed state. In some embodiments, the target site is apical cardiac tissue, and the method is performed as part of a trans-apical access procedure.