Stented Heart Valve Cooling via Thermal Conductor
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Solution Overview
Problem
Existing methods for compressing stented prosthetic heart valves for delivery systems often require cooling, which can expose the tissue to aqueous solutions, compromising the dry state of the valve material, and lack efficient mechanisms for maintaining the stent frame in a malleable state without direct liquid contact.
Innovation Solution
A method involving a cooling device with a thermally conductive chamber structure that separates the stented prosthetic heart valve from the cooling element, allowing heat transfer through a thermally conductive wall to cool the stent frame to a critical temperature without direct liquid exposure, enabling compression and loading onto a delivery system while maintaining the valve in a dry state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Temperature
If the stent frame is cooled using an ice bath based solution, then the nitinol frame enters the martensitic state and becomes malleable for compression, but the tissue is exposed to aqueous solutions which compromises the dry state of the valve material
Solution Approach 1:
A thermally conductive container serves as an intermediary between the cooling element and the stent frame. The container allows thermal energy transfer to cool the nitinol frame to martensitic state while physically isolating the tissue from direct contact with aqueous cooling solutions, thus maintaining the dry state of the valve material
Solution Approach 2:
The system is segmented into distinct functional zones: a cooling element chamber, a thermally conductive container holding the stent frame, and isolation barriers. This segmentation allows the cooling function to be separated from the tissue protection function, enabling independent optimization of each aspect
2Ease of operation
If the stent frame is cooled to critical temperature for compression, then the valve becomes malleable and can be loaded into delivery system, but the compression process requires direct contact with cooling solutions
Solution Approach 1:
The thermally conductive container acts as a mediator that enables compression operations while maintaining thermal isolation. The container can be compressed along with the cooled stent frame inside it, allowing the compression force to be applied without requiring the tissue to contact external cooling solutions
Solution Approach 2:
The thermally conductive container functions as a flexible shell that can be compressed while maintaining its thermal isolation properties. This thin-walled container allows mechanical compression forces to transmit to the stent frame while preventing liquid penetration to the tissue
3Productivity
If traditional cooling methods are used, then the stent frame can be compressed, but the process is complex and requires multiple steps including ice bath immersion and manual compression
Solution Approach 1:
The cooling and compression functions are merged into a single integrated device. The thermally conductive container allows both cooling to occur and subsequent compression to be performed on the same platform, eliminating the need for separate ice bath immersion and manual compression steps
Solution Approach 2:
The thermally conductive container serves multiple functions: it acts as a thermal conductor for cooling, a protective barrier for tissue isolation, a compression chamber for reducing the stent frame, and a loading guide for delivering the compressed valve. This multi-functionality simplifies the overall process and reduces device complexity
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
This approach effectively cools the stented prosthetic heart valve to a malleable state without exposing it to liquids, ensuring the valve remains in a dry state and facilitating efficient compression and loading onto a delivery system, enhancing the compatibility and stability of the valve during implantation.
Implementation Method 1
Heat is transferred from the first chamber to the second chamber through a thermally conductive wall to cool an interior of the first chamber
Implementation Method 2
The cooling process brings the valve out of the austenitic and into the martensitic phase. While in the martensitic phase, nitinol is more malleable
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C, and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.