Plication Lock Delivery System for Mitral Regurgitation Repair

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Solution Overview

Problem

Current catheter-based surgical procedures face challenges in securely anchoring and maintaining tension on sutures during and after tissue plication procedures, such as annuloplasty, due to the need for effective suture locks that can withstand movement and ensure lasting tissue plication.

Innovation Solution

A plication lock delivery system comprising a lock assembly with a lock body and pin, a catheter assembly with an outer sheath and inner catheter, and a control assembly that includes suture tension mechanisms and a lock deploy-and-release mechanism to securely apply and maintain tension on sutures, ensuring the lock assembly is deployed and released correctly within the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a lock assembly is used to secure sutures in catheter-based surgical procedures, then suture stability and tissue plication durability are improved, but the device complexity and difficulty of delivery increase

Engineering Contradiction:

Improvesuture stabilityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The lock assembly is divided into distinct functional components including a lock body, lock pin, and interaction features that engage with the catheter assembly. This segmentation allows each component to be optimized for its specific function while simplifying the overall delivery mechanism through modular design.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The lock assembly is designed to be nested within the catheter assembly during delivery, with the lock body positioned within the catheter lumen and the lock pin contained within the lock body. This nesting approach enables minimally invasive percutaneous delivery while maintaining the security function of the lock mechanism.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Duration of action of stationary object

If a lock assembly with pin and body structure is deployed to maintain suture tension, then tissue plication durability is improved, but the ease of operation and deployment difficulty increase

Engineering Contradiction:

Improvetissue plication durabilityVSAvoidease of deployment

Core Design Contradiction:

Duration of action of stationary objectVSEase of operation

Solution Approach 1:

The lock pin is pre-positioned within the lock body in a compressed or retracted state during delivery. Upon deployment, the pin automatically extends or engages with the lock body features, securing the suture tension without requiring complex manual manipulation during the critical deployment phase.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The lock assembly incorporates self-securing features where the lock pin automatically engages with the lock body through mechanical interaction features such as springs, cam surfaces, or friction fits. This self-service mechanism ensures reliable suture anchoring without requiring additional activation steps or complex operator intervention.

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS11395648B2Plication lock delivery system and method of use thereof

Publication Date: 2022.07.26 EDWARDS LIFESCIENCES CORP

AI summary

A plication lock delivery system that enables a suture lock assembly to be delivered percutaneously. The plication lock delivery system comprises a lock assembly that secures sutures in place, a control assembly that allows a clinician to engage a suture to a suture lock assembly, apply tension to the sutures to cause tissue plication, and deploy the lock assembly, and a catheter assembly. This plication lock delivery system can be used to repair mitral regurgitation percutaneously or in an open-heart surgery.