Transcatheter Heart Valve Delivery Tip Unit Support Extensions
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Solution Overview
Problem
Existing transcatheter prosthetic heart valve delivery systems face challenges with strut crossing and infolding during the loading and deployment of the prosthetic heart valve, which can lead to improper valve positioning and function.
Innovation Solution
The system includes a prosthetic heart valve with a stent frame that is transitionable between compressed and expanded conditions, and a delivery device with an outer shaft assembly and an inner shaft assembly. The delivery device features a tip unit and a tubular support body that minimize or prevent strut crossing and infolding by providing additional support to the stent frame during loading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the prosthetic heart valve is compressed and loaded onto the delivery device, then the valve can be delivered transcatheter, but strut crossing and infolding occur during loading and deployment
Solution Approach 1:
A support extension is introduced as an intermediary component between the delivery device and the stent frame. This support extension acts as a mediator that provides radial support to the stent frame during loading and deployment, preventing strut crossing and infolding while enabling transcatheter delivery. The support extension is temporarily engaged during the critical loading phase and then released after deployment.
Solution Approach 2:
The support extension is pre-positioned on the delivery device before the stent frame is loaded. This preliminary positioning ensures that the support extension is already in place to prevent strut crossing and infolding as the stent frame is compressed and engaged onto the delivery device, rather than attempting to correct these issues after they occur.
2Volume of moving object
If the stent frame is compressed for delivery, then the valve can be delivered through catheters, but the stent frame may infold or cross during compression
Solution Approach 1:
The support extension serves as a protective intermediary that maintains the structural integrity of the stent frame during compression. It provides radial support that prevents the stent frame struts from crossing or infolding as the overall volume is reduced for catheter delivery, then is removed after deployment when the stent frame expands to its full size.
3Manufacturing precision
If additional support structures are added to prevent strut crossing, then deployment accuracy improves, but device complexity increases
Solution Approach 1:
The support function is segmented into a separate, modular support extension component rather than being integrated into the main delivery device structure. This segmentation allows the support extension to be attached only when needed for loading and deployment, and then removed or left behind, reducing the complexity of the deliverable system while maintaining the necessary support function during critical operations.
Data Source
AI summary
A system including a prosthetic heart valve and a delivery device. The prosthesis includes a stent frame supporting a valve structure. The stent frame is transitionable between compressed and expanded conditions. The delivery device includes outer and inner shaft assemblies. The outer shaft assembly includes a capsule extending distally from an outer shaft. The inner shaft assembly is coaxially received within the outer shaft assembly, and includes an inner shaft, a valve retainer, and a tip unit. A proximal section of the tip unit extends from, and has an outer diameter greater than, the inner shaft. In a delivery state, the prosthesis is contained in the compressed condition over the inner shaft assembly by the capsule, a first region of the stent frame is connected to the valve retainer, and at least a portion of a second region of the stent frame contacts the proximal section of the tip unit.