Prosthetic Valve Catheter Positioning With Extendable Annulus Guides
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Solution Overview
Problem
Existing methods for accurately positioning prosthetic valves during transcatheter implantation, such as those using fluoroscopy and echography, are limited in accuracy and complexity, and additional components like retractable metal positioners add material to the implant or require complex radiographic contrast techniques.
Innovation Solution
Incorporating extendable positioning elements into the valve delivery catheter, which can be radially expanded and longitudinally displaced, allowing for precise alignment of the prosthetic valve by retractable members that engage with the native valve annulus before and after deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If retractable metal positioners are added to the prosthetic valve frame, then positioning accuracy is improved, but device complexity and material usage increase
Solution Approach 1:
The positioning elements are merged with the delivery catheter structure itself, rather than being separate components attached to the prosthetic valve. The catheter incorporates positioning elements that can engage the native valve annulus directly, eliminating the need for additional metal positioners on the valve frame.
Solution Approach 2:
The positioning function is extracted from the prosthetic valve frame and transferred to the delivery catheter. This allows the valve frame to remain simple while the catheter provides the positioning capability through its own integrated elements.
2Measurement precision
If radiographic contrast solution is injected into the prosthetic implant, then positioning visibility is improved, but procedural complexity increases
Solution Approach 1:
The positioning elements incorporate radiopaque materials that provide visibility under fluoroscopy without requiring injection of contrast solutions. The elements themselves are visible due to their inherent radiopacity, eliminating the need for complex contrast injection procedures.
3Measurement precision
If positioning elements are added to the prosthetic valve, then positioning accuracy is improved, but the implant size and material usage increase
Solution Approach 1:
The positioning function is combined with the delivery catheter rather than being added to the prosthetic valve. This eliminates the need for additional metal positioners on the valve frame, reducing the total material used in the implant while maintaining positioning accuracy.
4Manufacturing precision
If extendable limbs are used on the delivery catheter, then positioning precision is improved, but device complexity increases
Solution Approach 1:
The positioning elements are designed to be extendable and retractable, allowing them to be compact during delivery and then extended at the target site for positioning. This dynamic configuration provides positioning precision while maintaining a simple profile during the delivery phase.
Solution Approach 2:
The positioning system is segmented into multiple extendable limbs that can be independently controlled, allowing for precise positioning while keeping each individual component relatively simple in structure.
Data Source
Figure 1~4B
Figure 5~6B
Figure 7A~8B
AI summary
A device (14) for delivering prosthetic valve (12) such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements (34, 36), which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements lie against the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.