Artificial Chordae Tissue Ingrowth Coating for Valve Repair

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Solution Overview

Problem

Current cardiac valve repair methods often fail to effectively address valve abnormalities, leading to inadequate oxygen supply and quality of life issues due to insufficient tethering between heart valve leaflets and the ventricular wall.

Innovation Solution

An artificial chordae system comprising a surgical pad and a tether with a tissue ingrowth promoting coating is deployed to provide regenerated native tissue tethering, where the tether couples the heart valve leaflet to the ventricular wall, using a biodegradable membrane and a cord with a biomimetic micropattern to facilitate native tissue growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If traditional cardiac valve repair methods are used, then surgical intervention is required with full sternotomy and cardiopulmonary bypass, but patient trauma and procedure complexity increase significantly

Engineering Contradiction:
Improvesurgical accessibilityVSAvoidprocedure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The procedure is segmented into percutaneous delivery and surgical implantation phases, allowing the tether device to be delivered through a minimally invasive approach while the actual implantation can be performed through a smaller incision compared to traditional full sternotomy approaches

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The tether acts as an intermediary element that connects the valve leaflet to the ventricular wall, enabling mechanical support without requiring direct suturing or complex anchoring systems that would increase procedural complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If synthetic tethers are used to tether valve leaflets, then mechanical strength is provided, but biocompatibility issues and tissue rejection occur

Engineering Contradiction:
Improvetether mechanical strengthVSAvoidbiocompatibility issues
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The tether material parameters are changed from purely synthetic to a composite structure with a synthetic core providing strength and a biocompatible outer layer (such as ePTFE or biodegradable polymer) that promotes tissue integration and reduces rejection responses

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The tether is constructed as a composite material system combining a strong core material with an outer biocompatible layer, allowing simultaneous achievement of mechanical strength and tissue compatibility through material layering

Inventive Principle:
Principle #40Composite materials

3Reliability

If native tissue regeneration is promoted through biomimetic micropatterns, then long-term biocompatibility improves, but manufacturing complexity and coating precision requirements increase

Engineering Contradiction:
Improvelong-term biocompatibilityVSAvoidcoating precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The tether outer layer utilizes a porous structure (such as ePTFE) that naturally promotes tissue ingrowth and regeneration while the biomimetic micropattern coating is applied to guide cellular organization, combining material porosity with surface patterning

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The biomimetic micropattern coating is applied locally to specific regions of the tether where tissue integration is most critical, such as the portion embedded in the ventricular wall, rather than requiring uniform high-precision coating across the entire device

Inventive Principle:
Principle #3Local quality

4Ease of operation

If minimally invasive percutaneous delivery is used, then patient trauma is reduced, but delivery device complexity and procedural risk increase

Engineering Contradiction:
Improvepatient traumaVSAvoiddelivery device complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The tether device is designed with a nested structure that allows it to be collapsed and delivered through a percutaneous sheath, with the tether, surgical pad, and anchoring components nested within each other during delivery and deployed sequentially at the target site

Inventive Principle:
Principle #7Nested doll (Nesting)

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 artificial chordae system effectively regenerates native tissue tethering, improving valve function by enhancing the mechanical strength and reducing biocompatibility issues, while allowing for minimally invasive procedures, even on a beating heart.

Implementation Method 1

The tissue ingrowth promoting coating can be configured to promote native tissue growth over the cord to provide regenerated native tissue over the cord for coupling the heart valve leaflet to the heart wall

Methodology Applied
Scientific EffectTissue ingrowth:

Implementation Method 2

The cord can comprise a biomimetic micropattern on at least a portion thereof. The biomimetic micropattern can comprise a plurality of grooves

Methodology Applied
Scientific EffectBiomimetic micropattern:

Data Source

PatentUS20240148506A1Artificial chordae
Publication Date: 2024.05.09 EDWARDS LIFESCIENCES CORP
  • US20240148506A1 patent drawing
  • US20240148506A1 patent drawing
  • US20240148506A1 patent drawing

AI summary

An artificial chordae system can comprise a surgical pad configured to be externally positioned over an opening formed in a portion of a heart wall adjacent to a heart ventricle, and a tether comprising a cord and a tissue ingrowth promoting coating over at least a portion of the cord, the tether comprising a distal portion being configured to couple a heart valve leaflet and a proximal portion being coupled to the surgical pad. The tether can be dimensioned to extend from the heart valve leaflet through the heart ventricle to the opening in the heart wall, and through the opening in the heart wall to the surgical pad. The tissue ingrowth promoting coating can comprise a protein and be configured to promote native tissue growth over the cord to provide regenerated native tissue over the tether for coupling the heart valve leaflet to the heart wall.