Valve leaflet cinching via percutaneous suture delivery

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Solution Overview

Problem

Heart failure with reduced ejection fraction (HFrEF) and functional mitral valve regurgitation (FMR) pose challenges due to inadequate heart contraction and mitral valve leaflet separation, leading to oxygen-rich blood inefficiency and regurgitation, respectively, which existing treatments often require invasive surgeries or have poor outcomes.

Innovation Solution

A method involving a needle to deliver anchoring elements and a tethering suture into the heart's ventricle, penetrating heart valve leaflets to deploy anchoring elements and cinch the suture for desired valve coaptation, potentially reducing regurgitation without invasive surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional invasive surgery is used to treat mitral valve regurgitation, then valve repair can be achieved, but surgical complexity and patient risk increase

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidsurgical complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces traditional mechanical surgical intervention with a minimally invasive percutaneous approach using a delivery system that deploys anchoring elements and sutures through needle puncture, eliminating the need for open chest surgery and cardiopulmonary bypass

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The treatment system is divided into separate functional components: a delivery system with needle, detachable anchoring elements, and tethering sutures, allowing minimally invasive deployment while maintaining effective valve coaptation

Inventive Principle:

Principle #1Segmentation

2Ease of operation

If minimally invasive procedures are used, then patient recovery is improved, but procedural precision requirements increase

Engineering Contradiction:

Improvepatient recoveryVSAvoidprocedural precision

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The delivery system acts as an intermediary tool that combines precision needle puncture with controlled deployment of anchoring elements, enabling minimally invasive access while maintaining the precision needed for effective valve leaflet coaptation

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The anchoring elements are pre-positioned on the needle shaft before delivery to the heart valve, allowing precise placement and immediate engagement with the valve leaflets upon deployment, thereby achieving procedural precision without requiring complex real-time manipulation

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20230233326A1Valve leaflet cinching

Publication Date: 2023.07.27 EDWARDS LIFESCIENCES CORP

AI summary

A method comprises inserting a needle into a ventricle of a heart. The needle is configured to deliver a first anchoring element, a second anchoring element, and a tethering suture to the ventricle. The tethering suture is tethered between the first anchoring element and the second anchoring element. The method further comprises penetrating a first leaflet of a heart valve with the needle, penetrating a second leaflet of the heart valve with the needle, deploying the first anchoring element at a distal side of the second leaflet, retracting the needle from the first leaflet and the second leaflet, deploying the second anchoring element at a proximal side of the first leaflet, cinching the tethering suture to cause a desired amount of valve coaptation, and locking the tethering suture.