Nitinol Sheath Crimping Heart Valve After Deployment
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Solution Overview
Problem
Conventional delivery systems for self-expanding prosthetic heart valves do not allow for re-sheathing after full deployment, limiting the ability to test valve function and fitment, and full deployment can result in the valve 'jumping' or being improperly positioned, necessitating invasive surgery for removal.
Innovation Solution
A system comprising a delivery tube with a deployment device that includes a sheath and two moveable members to apply tension for crimping the valve after full deployment, allowing for repositioning and recapture of the valve within the delivery tube.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the valve is fully deployed to test function and fitment, then the valve can be assessed for proper positioning, but the valve cannot be repositioned or removed without invasive surgery
Solution Approach 1:
The delivery system maintains dynamic control over the deployed valve through the sheath and tensioning members, allowing the valve to transition between deployed and crimped states. This dynamic capability enables physicians to deploy the valve for functional assessment, then recrimp and reposition it if needed, eliminating the need for invasive removal surgery.
2Reliability
If the valve is fully deployed, then complete functional assessment is possible, but the valve diameter becomes larger than the delivery apparatus making re-sheathing impossible
Solution Approach 1:
The system allows dynamic transition of the valve between expanded and compressed states. After full deployment for assessment, the sheath can be repositioned and tensioning members adjusted to recrimp the valve, reducing its diameter back to fit within the delivery apparatus for potential repositioning or removal.
Solution Approach 2:
The delivery system is segmented into multiple controllable components including the sheath and tensioning members, allowing independent control of different valve sections. This segmentation enables selective crimping and deployment of valve portions, facilitating assessment followed by potential recapture.
3Ease of operation
If conventional delivery systems are used, then the valve can be deployed, but re-sheathing is limited to partial deployment only
Solution Approach 1:
The delivery system maintains dynamic control over the deployed valve through the sheath and tensioning members, allowing the valve to transition between deployed and crimped states. This dynamic capability enables physicians to deploy the valve for functional assessment, then recrimp and reposition it if needed, eliminating the need for invasive removal surgery.
Solution Approach 2:
The sheath and tensioning member system serves multiple functions: initial valve deployment, functional assessment during deployed state, recrimping for repositioning, and potential valve removal. This multi-functionality provides greater adaptability compared to conventional single-use delivery systems.
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 the physician to assess and correct the valve's function and fitment without full deployment, reducing the risk of invasive surgery and improving the precision of valve placement.
Implementation Method 1
The sheath may be formed of nitinol and be at least partially coated with a lubricant
Data Source
AI summary
A system for crimping a fully deployed heart valve includes a delivery tube extending in a longitudinal direction and having a lumen for receiving the crimped heart valve, a deployment device including a first member and a second member moveably secured to the first member, and a sheath configured to at least partially enclose a radially collapsible stent. A first attachment area of the sheath is connected to the first member and a second attachment area of the sheath is connected to the second member such that movement of the first member relative to the second member tensions the sheath for crimping the heart valve. A method of crimping a fully deployed heart valve is also provided.