Mitral Valve Repair via Percutaneous Shape Memory Anchors

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Solution Overview

Problem

Current treatments for mitral valve prolapse, such as open heart surgery, are invasive and pose significant risks to patients, with complications arising from the use of foreign materials in heart-lung bypass machines and lengthy recovery times.

Innovation Solution

A percutaneous method using a flexible cord with anchors made from shape memory materials, such as nickel titanium alloy, to secure and tension the cord between cardiac tissue and the prolapsed valve leaflet, allowing for real-time adjustment and correction of the valve position without the need for open heart surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgery is performed to treat mitral valve prolapse, then the valve can be repaired or replaced, but the surgery is highly invasive requiring thoracic incision, heart arrest, and heart-lung bypass machine usage

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidsurgical invasiveness and patient risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The procedure segments the valve repair process into percutaneous delivery of individual components (anchors, cords) rather than requiring complete surgical exposure. The first anchor is delivered to cardiac tissue and the second anchor to the valve leaflet separately through catheter-based approaches, dividing the monolithic surgical intervention into modular minimally invasive steps.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A flexible cord acts as an intermediary element connecting the first anchor in cardiac tissue to the second anchor in the valve leaflet. This cord transmits tension forces to reposition and secure the prolapsed leaflet without requiring direct surgical manipulation of the valve structures, enabling indirect repair through a mediator component.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If heart-lung bypass machine is used during surgery, then heart function is maintained during valve repair, but inflammatory reaction occurs due to foreign material contact with blood

Engineering Contradiction:

Improveheart function maintenanceVSAvoidinflammatory reaction from foreign materials

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The procedure extracts and eliminates the need for heart-lung bypass machinery from the treatment process. By using percutaneous delivery methods with catheters, the repair can be performed on a beating heart without requiring extracorporeal circulation, thereby removing the source of inflammatory reactions caused by foreign material contact with blood in machine components.

Inventive Principle:

Principle #2Taking out (Extraction)

3Reliability

If traditional open heart surgery is performed, then complete valve repair can be achieved, but recovery time is lengthy due to surgical invasiveness

Engineering Contradiction:

Improvevalve repair completenessVSAvoidpatient recovery time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The flexible cord provides dynamic adjustability after implantation, allowing tension to be optimized and the valve position to be fine-tuned post-deployment. This dynamic capability enables complete repair achievement through minimally invasive means, eliminating the need for lengthy recovery associated with rigid surgical interventions while maintaining repair effectiveness.

Inventive Principle:

Principle #15Dynamics

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 approach reduces invasiveness and risk, enabling less invasive treatment of mitral valve prolapse, allowing for correction of the valve position in a beating heart with reduced morbidity and eliminating the need for extracorporeal circulation, thereby shortening recovery time.

Implementation Method 1

At least one of the first or second anchors may be made from a shape memory material, and in some variations, the shape memory material is a nickel titanium alloy

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS7632308B2Methods, devices, and kits for treating mitral valve prolapse

Publication Date: 2009.12.15 AURIS HEALTH INC

AI summary

Described here are methods, devices, and kits for treating a prolapsed valve leaflet. The devices generally comprise a flexible cord, a first anchor attached to the cord at its distal end, and a second anchor slidably attached to the cord. The first anchor may be configured to secure the cord to cardiac tissue located below a prolapsed valve leaflet and the second anchor may be configured to secure into the prolapsed valve leaflet. Also described are methods for treating a prolapsed valve including the steps of securing a first anchor to cardiac tissue located below the prolapsed mitral valve leaflet, securing a second anchor to the prolapsed mitral valve leaflet, tensioning a cord connecting the two anchors and securing the cord. Kits including the described devices are also provided.