Self-Cinching Nitinol Clip for One-Sided Tissue Attachment

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Solution Overview

Problem

Current methods for attaching prosthetic heart valves to the native valve annulus are time-consuming and can cause tissue irritation due to the need for multiple sutures and sharp edges, and often require access to both sides of the tissue, which is impractical for certain valve positions.

Innovation Solution

A self-cinching clip delivery system using a super-elastic Nitinol clip that can be deployed from one side with a sharpened end, eliminating the need for sharp edges and reducing tissue irritation, by constraining the clip in a straight position within a tube assembly and allowing it to return to its relaxed shape for secure approximation of tissue layers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional suture methods are used to attach prosthetic heart valves, then secure attachment is achieved, but the procedure becomes time-consuming and requires access to both sides of the tissue

Engineering Contradiction:

Improveattachment speedVSAvoidaccess requirement

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The attachment procedure is segmented into discrete steps: first puncturing the tissue with a sharpened end, then deploying the clip to cinch the tissue layers together. This segmentation allows the procedure to be completed from one side only, eliminating the need for bilateral access while maintaining secure attachment

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The self-cinching clip acts as an intermediary device that bridges the tissue layers. The clip is deployed through a delivery system that punctures the tissue, and the clip's elastic properties allow it to cinch the tissue together from the puncture site, serving as a mediator that achieves secure attachment without requiring direct manipulation from both sides

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If sharp-ended clips are used to puncture tissue, then deployment from one side is enabled, but local tissue irritation occurs

Engineering Contradiction:

Improvedeployment accessibilityVSAvoidtissue irritation

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The clip's physical parameters are changed through the use of super-elastic Nitinol material, which allows the clip to be constrained in a straight configuration during delivery and then automatically return to its relaxed curved shape after deployment. This parameter change eliminates the need for sharp ends while maintaining the ability to puncture and deploy from one side

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The tissue puncture is performed preliminarily by the sharpened end of the delivery system before the clip is deployed. The clip itself is then deployed in a blunt configuration that cinches the tissue together without causing irritation. This preliminary action separates the puncture function from the clipping function, allowing the clip to be blunt while still enabling one-sided deployment

Inventive Principle:

Principle #10Preliminary action

3Reliability

If multiple sutures with knots are used to secure the prosthetic valve, then secure attachment is achieved, but the procedure time increases significantly

Engineering Contradiction:

Improveattachment securityVSAvoidprocedure time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The self-cinching clip performs the attachment function autonomously through its super-elastic properties. When deployed, the clip automatically returns to its relaxed configuration and cinches the tissue layers together without requiring manual knot tying or additional securing steps. This self-service mechanism maintains secure attachment while dramatically reducing procedure time

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The time-consuming knot-tying step is extracted from the attachment procedure. The clip's elastic cinching action replaces the multi-step suture and knot process, removing the time-consuming element while maintaining the security of attachment through the mechanical cinching force

Inventive Principle:

Principle #2Taking out (Extraction)

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 system significantly reduces the time required for heart valve attachment, minimizes tissue irritation, and allows for secure attachment with access from only one side, improving surgical efficiency and patient outcomes.

Implementation Method 1

Methodology Applied

Scientific EffectSuper-elasticity: Pseudoelasticity

Data Source

PatentUS11707280B2Methods of deploying self-cinching surgical clips

Publication Date: 2023.07.25 EDWARDS LIFESCIENCES CORP

AI summary

Devices and methods for deploying self-cinching surgical clips. A device can access at least two layers of tissue or material from only one side of the tissue or material and puncture through the two layers of tissue or material. The various configurations of clips disclosed herein can be made of a superelastic material such as Nitinol, and have a constrained and a relaxed state, and no sharp edges or tips so as to reduce tissue irritation following deployment. The clip can be disposed within the housing of the delivery device and held in a constrained state until deployment wherein the clip assumes its relaxed state, where the ends of the clip can be brought into close approximation, thereby securing the layers of tissue or material together.