Two-Catheter Valve Prosthesis Delivery for Tortuous Anatomy
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Solution Overview
Problem
Existing percutaneous delivery systems for prosthetic heart valves face challenges in efficiently delivering and deploying two-part valves due to bulkiness and time-consuming procedures, particularly when navigating through complex anatomical pathways like the septum, and often require complex sewing to the native tissue.
Innovation Solution
A valve delivery system comprising a first and second catheter, each carrying a frame of a two-part prosthetic heart valve, allows independent advancement and expansion of the frames at the implant site, with the first frame being positioned and secured within the second frame, facilitating efficient deployment through a tortuous path without the need for sewing to native tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a two-part prosthetic valve is delivered separately on two catheters, then the bulkiness is reduced and delivery through tortuous paths is facilitated, but the delivery procedure becomes more time-consuming and complex
Solution Approach 1:
The first catheter is nested within the second catheter, with the first frame disposed at the distal end of the first catheter and the second frame disposed at the distal end of the second catheter. This nested configuration allows both frames to be delivered through the same access point while maintaining separate control, reducing bulkiness for navigation through tortuous anatomical paths while enabling coordinated deployment to streamline the procedure
Solution Approach 2:
The prosthetic valve is divided into two separate frames that can be independently delivered and deployed. The first frame is deployed initially, then the second frame is deployed and attached to the first frame. This segmentation allows each frame to be optimized for specific functions and enables staged deployment that can reduce overall procedure time compared to delivering a single large assembly
2Reliability
If conventional sewing to native tissue is required, then secure attachment is achieved, but the procedure complexity and time increase
Solution Approach 1:
The valve prosthesis is designed with self-attachment capabilities where the first and second frames can attach to each other through mechanical interlocking or coupling mechanisms inherent in the frame design. This eliminates or reduces the need for separate sewing procedures to attach the valve to native tissue, maintaining secure attachment while simplifying the overall procedure and reducing procedural time
3Reliability
If a single large valve is delivered, then complete valve function is achieved, but navigation through tortuous anatomical paths becomes difficult
Solution Approach 1:
The valve is segmented into two frames that can be independently compressed and delivered on separate catheters. Each frame can be navigated through tortuous anatomical paths separately, avoiding the bulkiness issue of a single large valve assembly. The frames are then attached together at the deployment site to restore complete valve functionality
4Ease of operation
If two-part valve delivery is used, then bulkiness is reduced for better deliverability, but the attachment procedure between parts becomes more complex
Solution Approach 1:
The attachment mechanism between the first and second frames is integrated into the frame structures themselves, with coupling elements or interlocking features built into the design of each frame. This merging of the attachment function into the basic frame structure eliminates the need for separate attachment devices or complex external fixation procedures, simplifying the overall attachment process while maintaining secure connection between the two parts
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A
AI summary
A valve delivery system (20) including a valve prosthesis (10), a first catheter (22), and a second catheter (24). The valve prosthesis comprises a first frame (12) and a second frame (14). The first frame is configured to attach to the second frame The first frame is releasably disposable at the distal end (28) of the first catheter. The second catheter is slidably disposable over the first catheter. The second frame is releasably disposable at a distal end (29) of the second catheter