Prosthetic Valve Arms and Flanges for Percutaneous Anchoring
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Solution Overview
Problem
Ischemic heart disease causes regurgitation of heart valves due to papillary muscle dysfunction and valve annulus dilation, leading to decreased cardiac output and ventricular weakening.
Innovation Solution
A percutaneously deliverable prosthetic valve implant with a tubular portion and flanges that expand to secure the native valve, using a delivery tool with controlled capsule portions to facilitate precise deployment and expansion, ensuring secure anchoring and functional alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the prosthetic valve implant is delivered in a compressed state through a delivery tool, then the implant can be percutaneously delivered to the native heart valve, but the implant must be expanded at the native valve to secure anchoring
Solution Approach 1:
The prosthetic valve implant is nested within a delivery capsule that can be compressed and delivered through the vasculature. The delivery capsule acts as a protective sheath that allows the implant to be transported in a compact state and then deployed at the target location, resolving the contradiction between deliverability and anchoring security.
Solution Approach 2:
The implant transitions from a compressed state during delivery to an expanded state at the native valve. This dynamic transformation allows the implant to be delivered through constrained spaces and then achieve secure anchoring when expanded, addressing both deliverability and reliability requirements.
2Reliability
If the upstream support portion and flanges are expanded radially outward, then secure anchoring of the native valve is achieved, but the tubular portion must be expanded which brings the support portion and flanges closer together
Solution Approach 1:
The implant is divided into functionally independent segments: the tubular portion and the upstream support portion with flanges. These segments can be expanded independently or in sequence, allowing the support portion and flanges to protrude radially outward for anchoring while maintaining control over the expansion process and reducing overall complexity.
Solution Approach 2:
The upstream support portion and flanges are pre-configured to protrude radially outward from the tubular portion in a controlled manner during deployment. This preliminary action ensures that anchoring structures are positioned correctly before final expansion, simplifying the overall deployment mechanism while achieving secure anchoring.
3Manufacturing precision
If the delivery tool includes controlled capsule portions for sequential deployment, then precise deployment is achieved, but the device complexity increases
Solution Approach 1:
The delivery capsule is segmented into multiple portions that can be controlled independently. This segmentation allows sequential deployment of different implant components with precise control over each stage, achieving high deployment precision while managing complexity through modular design.
Solution Approach 2:
The delivery tool incorporates dynamic control mechanisms that allow the capsule portions to move sequentially in a controlled manner. This dynamic system enables precise deployment timing and positioning, achieving high manufacturing precision while the controlled nature of the complexity reduces operational difficulty.
Data Source
AI summary
A valve frame includes a tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around a longitudinal axis of the valve frame, and a plurality of arms, extending radially outward from an upstream portion of the tubular portion to define an arm span, and configured to engage tissue in the atrium. An outer frame is coupled to the valve frame, and includes a ring circumscribing the tubular portion, and a plurality of flanges that extend radially outward from the ring to define a flange span, and are configured to engage ventricular tissue. Each arm defines a rigid portion and a flexible portion that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion. The majority of the flexible portion is disposed further radially outward than the flange span. Other embodiments are also described.