TAVI Anchoring Scaffold with Cusp Loops for Valve Migration Prevention
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Solution Overview
Problem
Medical implants in body lumens often migrate due to lack of a stable foundation, as the wall of the lumen fails to provide sufficient anchoring, leading to instability and potential complications.
Innovation Solution
An expandable scaffold anchoring assistance device with a cusp interface section and crown end arrangement, configured to expand radially and include loop portions and deployment rings, which can engage with native heart valve leaflets to provide a stable anchoring mechanism, preventing migration of the implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the body lumen wall is used as the anchoring foundation, then the device structure remains simple, but the anchoring stability is insufficient causing implant migration
Solution Approach 1:
The anchoring assistance device is divided into multiple functional segments including an expandable scaffold with struts, anchoring elements (hooks/barbs), and a delivery system. This segmentation allows each component to perform its specific function: the scaffold provides structural support, the anchoring elements provide secure attachment to the lumen wall, and the delivery system enables minimally invasive placement, thereby achieving reliable anchoring without excessive overall complexity
Solution Approach 2:
The anchoring elements are pre-positioned on the expandable scaffold during manufacturing, ready for deployment. When the scaffold is expanded at the implantation site, the anchoring elements are already in place to engage with the body lumen wall, eliminating the need for separate anchoring steps and ensuring immediate stabilization of the medical implant
2Strength
If the anchoring assistance device is made rigid to provide stable foundation, then the anchoring strength improves, but the ease of delivery through body lumens decreases
Solution Approach 1:
The expandable scaffold transitions from a compressed low-profile state during delivery to an expanded high-strength state at the implantation site. This dynamic transformation allows the device to be easily delivered through narrow body lumens and catheters in a flexible compressed form, then provide rigid anchoring strength once expanded against the body lumen wall
Solution Approach 2:
The expandable scaffold is nested within a delivery catheter or sheath in a compressed state, allowing it to be delivered through narrow body lumens. Upon deployment, the scaffold expands outward from the delivery system, transforming from a compact deliverable form to an expanded anchoring structure that provides the necessary strength and stability
3Reliability
If the anchoring elements engage deeply with the body lumen wall to prevent migration, then the anchoring reliability improves, but the risk of tissue damage and harmful factors increases
Solution Approach 1:
The anchoring elements are designed with differentiated local properties: the tips or engagement surfaces are made with rounded or blunted geometries to minimize tissue penetration depth and reduce damage, while the shaft portions maintain sufficient strength for secure anchoring. This local quality differentiation allows the device to achieve reliable migration prevention without excessive tissue trauma
Solution Approach 2:
The anchoring elements are designed to engage with the body lumen wall in a controlled manner that converts the potential harm of deep penetration into beneficial secure anchoring. By optimizing the engagement depth and geometry, the device achieves reliable migration prevention while the controlled engagement minimizes tissue damage, effectively converting the potential harmful deep penetration into a beneficial shallow anchoring mechanism
Data Source
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AI summary
An implant system may include a delivery sheath having an actuator mechanism, an anchoring assistance device including an expandable scaffold including a mid-body (114) section, a cusp interface section (116), and a crown end arrangement(118), and a replacement heart valve implant. The cusp interface section includes a plurality of loop portions (134) arranged at radial intervals about the expandable scaffold. Each loop portion is circumferentially spaced apart from another loop portion by a region (133) having a deployment ring (134), the region being configured to span a commissure of the aortic valve and extending distally a shorter distance from the distal end than the loop portions. An elongate deployment member is configured to releasably engage with the deployment rings to actuate the expandable scaffold from a delivery configuration to a deployed configuration. The replacement heart valve implant is configured to be at least partially disposed within the expandable scaffold in the deployed configuration.