Altered-Matrix Sealing for Transcatheter Valve Leakage
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Solution Overview
Problem
Transcatheter valve prostheses experience paravalvular leakage due to incomplete conformance of the stent frame with the native valve, especially when calcified leaflets are pressed to the side walls, leading to significant pressure gradients and blood leakage through gaps.
Innovation Solution
A transcatheter valve prosthesis with a sealing component formed from tissue having an altered extracellular matrix, which includes weakened connections that swell upon contact with fluid, transforming from a compressed state for delivery to an expanded state for deployment, adapting to the native valve annulus and sealing gaps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stented prosthetic valve is delivered in a compressed condition and expanded within a diseased valve, then the valve replacement can be performed percutaneously with minimal invasiveness, but paravalvular leakage occurs due to incomplete conformance of the stent frame with the native valve
Solution Approach 1:
The patent applies a sealing component made from altered tissue that functions as a flexible membrane. This tissue has been chemically or mechanically modified to change its physical properties, allowing it to conform to the irregular native valve annulus geometry. The flexible nature of this thin film-like structure enables it to adapt to the anatomical variations and calcifications that rigid stent frames cannot accommodate, thereby preventing paravalvular leakage while maintaining the percutaneous delivery approach
Solution Approach 2:
The patent utilizes parameter changes by altering the extracellular matrix of the tissue through chemical or mechanical treatment. This modification changes the tissue's swelling characteristics, allowing it to increase in volume when exposed to blood or saline, thereby filling gaps between the stent frame and native valve. The parameter change from a compressed delivery state to an expanded functional state enables the sealing component to adapt dynamically to the implantation site geometry
2Strength
If calcified native leaflets are pressed to the side walls by the radial force of the stent frame, then the prosthetic valve can be secured in place, but complete conformance with the native valve is prevented, creating gaps for leakage
Solution Approach 1:
The sealing component acts as a flexible intermediary that can deform to match the irregular shape of the native valve annulus. Unlike the rigid stent frame that cannot conform to calcified or irregular anatomy, this flexible membrane can mold itself to the existing geometry, filling gaps and crevices created by calcified leaflets while maintaining the anchoring force provided by the stent
Solution Approach 2:
The patent employs a composite structure combining the rigid stent frame for structural support and anchoring with a flexible altered tissue sealing component for conformability. This composite approach allows the system to simultaneously achieve both strong anchoring through the stent's radial force and complete conformance through the sealing component's ability to adapt to irregular geometries
3Reliability
If the sealing component is formed from tissue with altered extracellular matrix that swells upon contact with fluid, then the tissue can expand to fill gaps and create a blood-tight seal, but the delivery profile and compressibility are challenged
Solution Approach 1:
The altered tissue's physical parameters are specifically modified to enable extreme compressibility during delivery while maintaining swelling capability upon implantation. The extracellular matrix alterations allow the tissue to be compressed to a small profile for catheter delivery, then swell when exposed to blood or saline at the implantation site, transforming from a compact delivery state to an expanded functional state that fills gaps and creates effective seals
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 sealing component effectively minimizes and eliminates paravalvular leakage by expanding to fit the irregular geometry of the native valve annulus, providing a blood-tight seal and preventing regurgitation.
Implementation Method 1
a sealing component coupled to the stent, wherein the sealing component is formed from a tissue having an altered extracellular matrix that includes at least one weakened connection such that the tissue is configured to swell upon contact with a fluid
Data Source
Figure 1~1A
Figure 1B~2
Figure 3~4
AI summary
A transcatheter valve prosthesis including a sealing component formed from a tissue having an altered extracellular matrix. The altered extracellular matrix includes at least one weakened connection such that the tissue is configured to swell or expand upon contact with a fluid. The altered extracellular matrix does not reduce compressibility of the tissue such that the delivery profile of the transcatheter valve prosthesis is not adversely affected. The tissue having an altered extracellular matrix transforms from a compressed state for delivery within a vasculature to an expanded state in situ when blood infiltrates or flows within the at least one weakened connection. The sealing component in the expanded state conforms to the geometry of the native valve tissue, thereby preventing paravalvular leakage at the implantation site.