Loader Sheath Tear Channels for Controlled Heart Valve Deployment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing prosthetic heart valve delivery systems face challenges in efficiently deploying balloon-expandable valves minimally invasively, particularly in ensuring precise positioning and expansion control during transcatheter procedures.
Innovation Solution
A prosthetic heart valve delivery system incorporating a loader sheath with weakened channels for controlled tearing and a tube design that includes semi-compliant and non-compliant materials for precise crimping and deployment, along with a fluid reservoir for balloon pressurization and air bubble removal, facilitates controlled expansion and positioning of the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a loader sheath is used to surround and protect the crimped prosthetic heart valve, then protection and positioning are improved, but device complexity increases
Solution Approach 1:
The loader sheath is divided into distinct functional segments: a proximal hub for coupling, a tubular body for protection, and integrated tear channels for controlled opening. This segmentation allows each component to perform its specific function while maintaining overall system reliability without excessive complexity.
Solution Approach 2:
The loader sheath acts as an intermediary device between the delivery system and the prosthetic heart valve. It provides a protective interface that allows the valve to be transported and positioned while maintaining control over the deployment process through its tear channel mechanism.
2Ease of operation
If the tube is designed with weakened areas to promote tearing, then controlled expansion is improved, but manufacturing precision requirements increase
Solution Approach 1:
The tear channels are pre-formed during manufacturing as predetermined weakened areas in the tube wall. This preliminary action ensures that during deployment, the tube will tear along specific, controlled paths when force is applied, enabling predictable expansion without requiring high precision during the actual deployment operation.
Solution Approach 2:
The tube material properties are modified during manufacturing to create regions with different strength characteristics. The weakened areas have reduced tensile strength compared to the rest of the tube, allowing controlled tearing at specific locations while maintaining structural integrity elsewhere in the loader sheath.
3Ease of operation
If the first and second channels open to the inner diameter of the tube, then ease of operation is improved, but device complexity increases
Solution Approach 1:
Both the first and second tear channels are integrated into a single tube structure, merging multiple functional elements into one component. This design allows the tube to provide both protection and controlled expansion capabilities simultaneously, reducing the need for separate mechanisms and simplifying the overall device architecture.
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 and controlled deployment of balloon-expandable prosthetic heart valves, ensuring accurate positioning and minimally invasive implantation with reduced risk of complications.
Implementation Method 1
Pressurizing the balloon may cause at least one air bubble within the balloon to compress
Implementation Method 2
The first channel and the second channel may form weakened areas to promote tearing of the tube along the first channel and along the second channel
Data Source
AI summary
A prosthetic heart valve delivery system may include a delivery device having a balloon at a distal end thereof, a balloon-expandable prosthetic heart valve configured to be received on the balloon in a crimped condition, and a loader sheath configured to at least partially surround the crimped prosthetic heart valve while the crimped prosthetic heart valve is received on the balloon. The loader sheath may include a tube and a proximal hub. The loader sheath may include a first channel extending in an axial direction along a wall of the tube and a second channel extending parallel to the first channel. The first channel and the second channel may form weakened areas to promote tearing of the tube along the first channel and along the second channel.