Percutaneous Catheter Delivery for Collapsed Valve Containment
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Solution Overview
Problem
Existing transcatheter delivery devices for prosthetic mitral and tricuspid valves face challenges in maintaining the prosthetic heart valve in a collapsed state during delivery due to frictional forces, often requiring separate introducers that increase the overall system size and necessitate vessel cut-downs, while eliminating the introducer is desirable for reduced size and ease of insertion.
Innovation Solution
A delivery system with a catheter assembly featuring a first catheter with a coiled or braided section and a second catheter with higher resistance to longitudinal compression, coupled by a connecting ring and valve retainer mechanism that allows for precise control between locked and unlocked states, enabling safe deployment of the prosthetic heart valve without a separate introducer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate introducer is used to maintain the prosthetic heart valve in a collapsed state during delivery, then the reliability of valve containment is improved, but the device complexity and overall system size increase
Solution Approach 1:
The patent combines the functions of the introducer and the delivery catheter into a single integrated catheter assembly. The outer catheter serves both as the delivery vehicle and as the containment structure for the prosthetic heart valve, eliminating the need for a separate introducer device while maintaining reliable valve containment throughout the delivery process.
Solution Approach 2:
The outer catheter is designed to perform multiple functions: it serves as the structural framework of the delivery system, provides containment for the collapsed prosthetic valve, and acts as the delivery conduit through the patient's vasculature. This multi-functional design replaces the traditional separate introducer device.
2Reliability
If a separate introducer is used to maintain the prosthetic heart valve in a collapsed state, then the reliability of valve containment is improved, but the ease of insertion deteriorates due to increased system size and vessel cut-down requirements
Solution Approach 1:
By merging the introducer and delivery catheter functions into a single integrated assembly, the system achieves a more compact size that can be inserted through standard vascular access without requiring additional vessel cut-down procedures, thereby improving ease of insertion while maintaining valve containment reliability.
3Ease of operation
If the catheter assembly uses a coiled or braided section to accommodate compression forces, then the ease of operation during delivery is improved, but the manufacturing precision and structural complexity increase
Solution Approach 1:
The catheter assembly incorporates a coiled or braided section specifically at the distal end where compression forces are most likely to occur during delivery. This localized structural enhancement provides the necessary compression resistance while maintaining simpler construction in other portions of the catheter, thereby balancing operational ease with manufacturing considerations.
Data Source
AI summary
A delivery system for delivering a prosthetic heart valve, the delivery system including: a handle assembly; a catheter assembly extending from the handle assembly, the catheter assembly having a first catheter and a second catheter positioned radially inside the first catheter; a connecting ring fixed to a distal end portion of the first catheter; and a valve retainer fixed to a distal end portion of the second catheter, the valve retainer configured to receive at least a portion of the prosthetic heart valve therein, wherein the catheter assembly has i) a locked state in which the valve retainer is axially locked relative to the connecting ring, and ii) an unlocked state in which the valve retainer is axially movable relative to the connecting ring, the handle assembly being configured to actuate the catheter assembly between the locked state and the unlocked state.