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
Engineering 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
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
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
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
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
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
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
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
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
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
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
Data Source
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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.