Self-Expanding Prosthetic Valve Delivery With Lateral Position Control
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Solution Overview
Problem
Existing transcatheter prosthetic heart valve delivery systems lack control over the lateral position of the prosthetic heart valve relative to the delivery device during deployment, leading to potential interference with valve leaflets and difficulties in functional evaluation.
Innovation Solution
The delivery device incorporates a spindle and flexible cords to compress and retain the stented prosthetic heart valve, with a lateral control feature that directs the spindle to a prescribed location relative to the prosthesis, allowing for precise positioning and evaluation before full deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the prosthetic heart valve is deployed using conventional delivery systems, then the valve can be implanted, but the lateral position of the valve relative to the delivery device cannot be controlled, causing interference with valve leaflets
Solution Approach 1:
A lateral control feature acts as an intermediary mechanism between the delivery device and the prosthetic heart valve. This feature includes a lateral control element that can be selectively engaged to direct the spindle to a prescribed location relative to the prosthesis, thereby controlling the lateral position during deployment without requiring complex manual manipulation
Solution Approach 2:
The lateral control feature is designed to be selectively engageable and disengageable, allowing dynamic adjustment of the spindle position relative to the prosthesis. This enables the operator to transition between different operational states (controlled positioning vs. free deployment) as needed during the procedure
2Reliability
If the prosthetic heart valve is deployed without lateral position control, then the deployment process is simpler, but functional evaluation becomes difficult due to interference with leaflets
Solution Approach 1:
The lateral control feature serves as a mediator that enables accurate functional evaluation by positioning the spindle at a prescribed location relative to the prosthesis. This prescribed positioning prevents interference with valve leaflets during hemodynamic assessment, thereby improving reliability of functional evaluation
Solution Approach 2:
The lateral control feature allows the spindle to be pre-positioned at the prescribed location before functional evaluation begins. This preliminary positioning ensures that the valve is in the optimal configuration for assessment, preventing interference with leaflets before the evaluation process starts
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise positioning of the prosthetic heart valve, minimizing interference with leaflets and facilitating effective hemodynamic assessment, ensuring proper valve function and deployment accuracy.
Implementation Method 1
The frame can be contracted during percutaneous transluminal delivery, and expanded upon deployment at or within the native valve. With one type of stented prosthetic heart valve designs, the stent frame is formed to be self-expanding.
Data Source
AI summary
Delivery devices for delivering a self-expanding prosthetic heart valve are disclosed. The delivery device includes at least one cord is configured to selectively cinch the self-expanding prosthetic heart valve. The delivery device further includes at least one self-expanding release pin comprising a proximal segment, a distal segment, and an intermediate segment positioned between the proximal segment and the distal segment. The at least one self-expanding release pin includes a normal, expanded condition wherein the intermediate segment extends radially outward relative to a central axis of the spindle from the proximal segment to the distal segment. The delivery device further includes a capsule configured to be distally extended relative to the spindle to collapse the at least one self-expanding release pin from the normal, expanded condition of the at least one self-expanding release pin to a collapsed condition of the at least one self-expanding release pin.