Transluminal Prosthetic Valve Delivery With Nested Catheter Capsules
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Solution Overview
Problem
Dilation of the annulus of a heart valve due to ischemic heart disease prevents the valve leaflets from fully coapting, leading to regurgitation and decreased cardiac output.
Innovation Solution
A transluminal delivery system using a multi-catheter system and implantation instrument for delivering a prosthetic heart valve, with adjustable catheter positions and a capsule assembly for controlled deployment and expansion at the native valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic heart valve is delivered transluminally to treat annular dilation, then valve function and cardiac output are improved, but the complexity of the delivery system increases
Solution Approach 1:
The delivery system is divided into multiple catheter units (first catheter unit with first catheter, second catheter unit with second catheter) that can be independently controlled. Each catheter has its own handle for selective adjustment of axial and rotational positions, allowing complex valve deployment through coordinated action of simpler individual components
Solution Approach 2:
The first catheter extends distally from within the second catheter, creating a nested configuration. The distal portion of the first catheter can be slid over the distal portion of the second catheter to ensheathe it, or slid proximally to expose it. This nested structure allows compact delivery while enabling independent manipulation of each catheter
2Measurement precision
If multiple catheters are used to control implant position, then positioning precision is improved, but the ease of operation decreases
Solution Approach 1:
The proximal portions of both catheters and the implantation instrument are mounted on a common mount for stabilization during use. This merging of multiple control elements into a single stabilized platform reduces operational complexity while maintaining the precision benefits of multiple independently adjustable catheters
3Ease of operation
If the catheter distal portions are made flexible for navigation, then ease of delivery is improved, but the control precision worsens
Solution Approach 1:
The distal portions of both catheters are made actively bendable through control elements (pull wires) that extend from the handles through the catheter lumens to the distal portions. This dynamic flexibility allows the catheters to navigate complex vasculature while maintaining precise positional control through active manipulation of the pull wires
Data Source
AI summary
A percutaneous delivery tool includes a shaft, and proximal and distal capsules which move axially with respect to the shaft. A prosthetic valve includes a tubular portion, an upstream support portion extending therefrom and a plurality of flanges each having a respective flange end-portion. The prosthetic valve is restrainable by the delivery tool, such that the shaft and a downstream end of the tubular portion are disposed within the distal capsule, and the upstream support portion and the flange end-portions are disposed within the proximal capsule. Other embodiments are also described.