Prosthetic Valve Apex Coverings for Balloon-Safe Deployment
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Solution Overview
Problem
Prosthetic valves with exposed apices can damage or penetrate the delivery balloon and delivery shaft during crimping and deployment, leading to potential vasculature damage and inadequate inflation.
Innovation Solution
The prosthetic valve is equipped with apex coverings that cover each apex, featuring an opening for insertion and an inner pocket to accommodate the apex, preventing direct contact with the balloon and shaft.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the prosthetic valve uses exposed apices formed by angled struts, then the frame structure is simple and rigid, but the balloon and delivery shaft can be damaged or penetrated during crimping and deployment
Solution Approach 1:
The patent introduces apex coverings as intermediary protective elements that cover the exposed apices of the frame. These coverings are made of biocompatible material and are attached to the frame at the apex locations, serving as a mediator between the rigid frame structure and the soft balloon/delivery shaft, preventing direct contact and potential damage while maintaining frame rigidity
Solution Approach 2:
The apex coverings are implemented as thin-walled protective shells made of flexible biocompatible material. These shells conform to the apex geometry and provide protection through their film-like structure, allowing them to deform during crimping while still protecting the underlying frame apex from penetrating the balloon
2Ease of manufacture
If the prosthetic valve has pointy exposed apices, then manufacturing is simpler, but the leading apices can scrape or penetrate the delivery shaft and balloon wall during axial advancement
Solution Approach 1:
The apex coverings serve as protective intermediaries attached to the frame apices, preventing direct interaction between the sharp frame apices and the delivery system components. This mediator layer enables reliable delivery by eliminating the scraping and penetration risks while requiring minimal modification to the manufacturing process
Solution Approach 2:
The apex coverings are attached to the frame apices before the valve is crimped onto the balloon and before delivery. This preliminary protective action ensures that the apices are already covered and protected before any potential damaging interactions with the delivery system can occur
Data Source
AI summary
The present disclosure relates to a prosthetic valves that include an apex coverings attached to apices of their frames, configured to form atraumatic contact surfaces around the apices. In an example, an apex covering includes an opening through which the apex can be inserted into an inner pocket of the apex covering. The apex covering can define an outer surface that can be curved and relatively smooth. The apex covering can include a pair of flexible arms that can rest over angled struts extending from the apex, so as to increase contact area between the apex and the apex covering. Sutures can be optionally used to couples the apex covering to the frame, forming loops around the frame and grooves formed along the outer surface of the apex covering.