Transapical Catheter Capsule for Smooth Valve Retraction
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Solution Overview
Problem
Current heart valve delivery systems face issues with hang-ups and snagging during deployment and removal, which can lead to procedural risks and potential damage to the prosthesis or patient.
Innovation Solution
A delivery system with a distal moving capsule and a continuous profile design that minimizes snagging, featuring a handle assembly with a rotatable control knob, a catheter with an introducer shaft and inner shaft, and a capsule that can be advanced distally to deploy the prosthesis, ensuring smooth deployment and retraction by mating with a radiopaque atraumatic tip and a valve retainer to prevent 'fish mouthing'.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delivery system with edges or distinct segments is used for prosthesis delivery, then the prosthesis can be deployed, but the edges cause hang-ups and snagging during deployment and removal
Solution Approach 1:
The delivery system employs a continuous curved profile instead of straight edges or angular segments. The catheter and capsule are designed with smooth curved transitions that eliminate sharp edges, preventing them from catching on the prosthesis during deployment and removal operations
Solution Approach 2:
The delivery system is divided into distinct functional segments (introducer catheter, capsule, valve retainer) that can move independently. The capsule can be advanced separately from the introducer, and the valve retainer can be positioned independently, allowing each component to be optimized for its specific function while maintaining overall smoothness
2Reliability
If a complex delivery system with multiple components is used, then the prosthesis can be deployed safely, but the system becomes more complex and harder to operate
Solution Approach 1:
The delivery system uses a nested configuration where the capsule is positioned within the introducer catheter, and the valve retainer is positioned within the capsule. This nested arrangement allows multiple components to be housed within each other, reducing the overall footprint and simplifying the operational sequence while maintaining the necessary functional complexity
Solution Approach 2:
The introducer catheter serves multiple functions: it provides the initial access pathway, acts as a guide for capsule positioning, and serves as a protective sheath during removal. The capsule both delivers the prosthesis and acts as a protective covering during deployment. This multi-functionality reduces the need for separate components
3Loss of time
If the delivery system is withdrawn quickly after deployment, then the procedure time is reduced, but trauma to the expanded valve and body channels increases
Solution Approach 1:
The continuous curved profile of the delivery system allows for smoother withdrawal through the expanded valve and body channels. The curved transitions distribute mechanical stress more evenly across the valve structure compared to sharp edges, reducing trauma while maintaining withdrawal speed
Solution Approach 2:
The valve retainer and capsule are designed with rounded, cushioned surfaces that gently contact the valve leaflets and channels during withdrawal. These pre-designed cushioning elements prevent direct contact between sharp edges and the valve tissue, reducing trauma even during rapid withdrawal
Data Source
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AI summary
Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly with a rotatable control knob and a catheter including an introducer shaft, an intermediate shaft extending from the handle assembly, an inner shaft extending from the handle assembly, and a capsule for containing a prosthesis. The distal end of the capsule can be connected to a distal end of the inner shaft, which can be moved in a distal direction by the rotatable control knob to deploy the prosthesis. By advancing the introducer through the deployed prosthesis and retracting the capsule to mate with the introducer, a smooth profile can be created for retraction of the system through the deployed prosthesis, minimizing hang-ups and snagging.