Stented Prosthetic Heart Valve With Deployable Paravalvular Leakage Mitigation Wrap
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Stented prosthetic heart valves often experience paravalvular leakage due to incomplete conformance with calcified native leaflets, leading to significant pressure gradients and detrimental blood leakage, which is not adequately addressed by existing transcatheter delivery methods.
Innovation Solution
A stented prosthetic heart valve with a deployable wrap that can be actuated independently of the stent frame configuration to fill commissural paravalvular leakage pathways, using tethers and coupling elements to maintain the wrap in a deployed position, and optionally biased to remain in the deployed state once forces are released.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stented prosthetic heart valve is delivered percutaneously using a catheter-based delivery system, then the procedure is less invasive and safer, but paravalvular leakage occurs due to incomplete conformance with calcified native leaflets
Solution Approach 1:
The valve assembly is divided into separate functional components: the stented prosthetic valve and the wrap are deployable independently. The wrap can be deployed after the valve to specifically address paravalvular leakage without requiring re-intervention, as the two components can be selectively actuated at different times
Solution Approach 2:
The wrap is configured to transition from a compressed delivery state to an expanded deployed state where it bulges outwardly to fill gaps. The wrap's configuration is dynamically adjustable and can be selectively actuated independent of the stent frame expansion, allowing adaptation to varying anatomical conditions
2Object-affected harmful factors
If the wrap is configured to bulge outwardly to fill gaps, then paravalvular leakage is reduced, but the device complexity increases
Solution Approach 1:
The wrap is nested within the delivery catheter in a compressed state during delivery, then expanded outwardly at the target site. The tethers are routed through the delivery device and attached to the wrap, allowing the wrap to be pulled into deployment position while remaining contained within the delivery system until needed
Solution Approach 2:
Tethers serve as intermediary elements connecting the delivery device to the wrap. The tethers transmit force from the delivery device to the wrap to achieve deployment, and can be selectively actuated independent of the stent frame expansion mechanism
3Adaptability or versatility
If the wrap is selectively deployable independent of stent frame configuration, then paravalvular leakage can be addressed after valve deployment, but the device complexity increases
Solution Approach 1:
The actuation mechanisms for the stent frame and wrap are segmented into independent systems. The stent frame has its own expansion mechanism while the wrap has separate tethers attached to the delivery device, allowing each component to be deployed independently based on anatomical needs
Solution Approach 2:
The wrap is prepared in a compressed state within the delivery device, ready for selective deployment. The tethers are pre-positioned and attached to the delivery device, allowing the wrap to be deployed at any time after valve implantation by simply actuating the tether mechanism
Data Source
Figure 1~2
Figure 3A~3D
Figure 4A~5D
AI summary
Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient's vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.