Recapture Frame Funnel Shape for Prosthetic Heart Valve Repositioning
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Solution Overview
Problem
Current transcatheter systems for percutaneous heart valve implantation lack the capability for accurate partial deployment, recapturing, and repositioning of stented prosthetic heart valves due to the high radial expansion force of the prosthesis and the limitations of conventional delivery sheaths, which often result in incomplete recapture and potential complications.
Innovation Solution
A delivery system comprising an inner shaft assembly, a delivery sheath capsule, and a recapture assembly with a transitionable recapture frame and sleeve that forms a funnel shape, allowing for the compression and recapture of a partially deployed prosthetic heart valve, enabling precise positioning and repositioning of the valve before full deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional delivery sheath is used to compress and retain the stented prosthetic heart valve, then the valve can be delivered through the catheter, but the sheath cannot recapture the valve due to high radial expansion force
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery sheath for initial compression and delivery, and a recapture assembly with expandable frame for recapture. This segmentation allows each component to be optimized for its specific function without compromise.
Solution Approach 2:
The recapture assembly acts as an intermediary device between the delivered valve and the delivery sheath. It provides a mechanical interface that can engage the expanded valve and transmit recapture forces, overcoming the limitation of the delivery sheath alone.
2Reliability
If the stented prosthetic heart valve is allowed to self-expand to a larger diameter, then it can function properly, but it cannot be recaptured by the delivery system
Solution Approach 1:
The recapture frame is designed to be dynamically transitionable between compressed and expanded states. When expanded, it forms a funnel shape that can engage and guide the self-expanded valve back into the delivery sheath, enabling recapture while maintaining valve functionality.
Solution Approach 2:
The system changes the physical state and configuration of the recapture frame from compressed to expanded, altering its geometric parameters to create an engaging funnel shape that facilitates valve recapture without compromising valve function.
3Reliability
If the delivery system provides sufficient radial strength to overcome expansion forces, then recapture becomes possible, but the system complexity increases
Solution Approach 1:
The recapture assembly with its expandable frame is nested within the delivery system architecture. When not in use, it remains compact within the catheter assembly, and only deploys when needed for recapture, minimizing complexity during normal delivery while enabling recapture functionality.
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 system allows for successful partial deployment, evaluation, and recapturing of the prosthetic heart valve, overcoming the limitations of existing systems by providing the necessary radial strength and articulation for accurate placement and repositioning, thereby reducing the risk of complications and improving implantation precision.
Implementation Method 1
The frame is transitionable from a compressed arrangement to an expanded arrangement in which the frame forms a funnel shape
Implementation Method 2
the capsule is compressively retaining the prosthetic heart valve in the compressed arrangement
Implementation Method 3
the prosthetic heart valve is radially self-expandable from a compressed arrangement to a deployed arrangement
Data Source
Figure 1A~1C
Figure 2
Figure 3~4B
AI summary
A delivery system (30) for percutaneously deploying a stented prosthetic heart valve (160) is disclosed, including an inner shaft assembly (34) including an intermediate portion providing a coupling structure (120) configured to selectively engage a stented prosthetic heart valve (160). The delivery system (30) includes a delivery sheath capsule (40) slidably disposed over the inner shaft assembly (34) and configured to compressively contain a stented prosthetic heart valve (160). A recapture assembly (32) is slidably disposed over the inner shaft assembly (34), the recapture assembly (32) including a recapture frame (42) and a sleeve (50) coupled to the frame (42). The frame (42) is transitionable from a compressed arrangement to an expanded arrangement in which the frame (42) has a distally increasing diameter, configured to recapture a partially deployed prosthetic heart valve (160). The system (30) has a loaded state in which the capsule (40) compressively retains the stented prosthetic heart valve (160) over the inner shaft assembly (34) and the recapture assembly (32) is longitudinally displaced from the stented prosthetic heart valve (160).