Stentless Support Structure for Minimizing Emboli in Percutaneous Valves

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Solution Overview

Problem

Current percutaneous valve replacement methods using stents face issues such as emboli generation, paravalvular leakage, limited conformability, tradeoff between strength and compressibility, non-retrievability, and increased delivery size, which complicate the procedure and patient recovery.

Innovation Solution

A tubular mesh support structure made from braided shape-memory strands that can be delivered through a small catheter, gradually expands to conform to the lumen, traps emboli, and can be retracted for repositioning, allowing for a smaller delivery size and reduced trauma.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a stent is used as support scaffolding for the prosthetic valve, then the valve can be delivered percutaneously, but the stent creates emboli when it expands

Engineering Contradiction:
Improvepercutaneous delivery capabilityVSAvoidemboli generation
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The patent removes the stent component from the valve assembly, delivering the prosthetic valve without stent support scaffolding. The valve is delivered in a compressed state within a catheter and deployed directly at the target site, eliminating the emboli-generating stent expansion process while maintaining percutaneous delivery capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The prosthetic valve is constructed with flexible membrane structures that can be compressed to fit within a catheter for percutaneous delivery, then expand to their functional configuration at the implantation site without requiring a rigid stent framework, thereby avoiding emboli generation

Inventive Principle:
Principle #30Flexible shells and thin films

2Ease of operation

If a stent is used to support the prosthetic valve, then the valve can be implanted percutaneously, but the stent does not conform to the features of the native lumen, causing paravalvular leakage

Engineering Contradiction:
Improvepercutaneous implantationVSAvoidsealing performance
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The prosthetic valve is designed with adjustable geometric parameters including radial expandability and axial compression, allowing it to adapt to the specific dimensions and shape of the native lumen during deployment. This enables the valve to conform to the patient's anatomy without requiring a stent, preventing paravalvular leakage while maintaining percutaneous implantation

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The valve structure incorporates dynamic elements that allow it to transition from a compressed delivery state to an expanded functional state, adapting its shape and size to match the native lumen features during the implantation process, thereby achieving both percutaneous delivery and reliable sealing

Inventive Principle:
Principle #15Dynamics

3Ease of operation

If a stent is used for valve support, then the valve can be delivered percutaneously, but there is a tradeoff between stent strength and compressibility

Engineering Contradiction:
Improvepercutaneous deliveryVSAvoidstructural strength vs compressibility tradeoff
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The prosthetic valve utilizes flexible membrane structures with engineered mechanical properties that provide sufficient structural strength in the deployed state while allowing extreme compression for percutaneous delivery. The flexible construction eliminates the need for a stent, resolving the strength-compressibility tradeoff by achieving both high compressibility for delivery and adequate strength for functional support

Inventive Principle:
Principle #30Flexible shells and thin films

4Ease of operation

If a stent is used to support the prosthetic valve, then the valve can be implanted percutaneously, but the collapsed diameter of the stent-valve complex increases, requiring larger delivery catheter caliber

Engineering Contradiction:
Improvepercutaneous valve replacementVSAvoidcollapsed diameter
Core Design Contradiction:
Ease of operationVSLength of moving object

Solution Approach 1:

By removing the stent from the valve assembly, the patent significantly reduces the collapsed diameter of the implantable complex. The valve alone can be compressed to a much smaller profile than a stent-valve combination, enabling delivery through smaller caliber catheters while maintaining percutaneous valve replacement capability

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 solution minimizes emboli generation, prevents paravalvular leakage, provides adjustable strength, and allows for precise placement and retrieval of the support structure, enhancing the safety and efficacy of percutaneous valve replacement.

Implementation Method 1

The strands exhibit shape memory such that the elongate tube may be formed into a desired folded shape, then stretched out into a very small diameter, elongated configuration

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP3482717B1Stentless support structure
Publication Date: 2023.09.06 EDWARDS LIFESCIENCES CORP
  • EP3482717B1 patent drawingFigure 1~2
  • EP3482717B1 patent drawingFigure 3~6
  • EP3482717B1 patent drawingFigure 7~9

AI summary

Disclosed is a prosthetic valve assembly including a tube, a wireform, and a valve attached to the wireform and configured such that the tube folds inwardly, and the wireform is at least partly contained within an interior of the tube.