Transcatheter Heart Valve Loader for Retrieval and Protected Crimping
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Solution Overview
Problem
Existing transcatheter heart valve delivery systems face challenges in effectively crimping the valves without damaging the tissue leaflets and simplifying the introduction and retrieval process, particularly when the valve is slightly expanded during delivery.
Innovation Solution
A loader assembly with varying diameters and seals is used to load and retrieve transcatheter heart valves into and from a delivery sheath without removing the sheath, and a combined storage, crimping, and loader system simplifies the crimping process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If the valve is crimped to reduce radial width for delivery, then the valve can be delivered through catheters and sheaths, but the tissue leaflets may be damaged or deformed
Solution Approach 1:
A protective sheath is introduced as an intermediary element between the crimping device and the valve tissue leaflets. The sheath absorbs the mechanical stress of crimping while protecting the delicate tissue from direct contact with the crimping jaws, thereby enabling valve compression without tissue damage.
Solution Approach 2:
The protective sheath is placed on the valve before crimping occurs, creating a cushioning layer that prevents direct mechanical trauma to the tissue leaflets during the compression process. This beforehand protection allows the valve to be crimped to the necessary radial width for delivery.
2Ease of operation
If the delivery sheath is removed to retrieve the valve, then the valve can be completely removed from the patient, but the procedure becomes more complex and time-consuming
Solution Approach 1:
A retrieval device is extracted and introduced through the delivery sheath to facilitate valve removal. The retrieval device engages with the valve and allows it to be pulled back through the sheath without removing the sheath itself, thereby simplifying the retrieval process while maintaining sheath integrity.
Solution Approach 2:
The delivery sheath is designed to remain in place while providing a pathway for valve retrieval through the introduction of a retrieval device. The system allows the sheath to serve its protective function continuously while enabling easy valve removal without requiring sheath removal, making the retrieval process self-contained within the existing sheath structure.
3Object-affected harmful factors
If a protective sheath is used during crimping, then the tissue leaflets are protected from damage, but the crimping process becomes more complex
Solution Approach 1:
The protective sheath is designed to serve multiple functions: it protects the tissue leaflets during crimping, maintains valve integrity, and facilitates the crimping process itself. By making the sheath multi-functional, the system avoids adding separate protective mechanisms that would increase overall complexity.
Data Source
AI summary
A method for crimping a prosthetic heart valve is disclosed. The method includes mounting a prosthetic heart valve on a valve holder, inserting the prosthetic heart valve into an aperture of a crimping device, inserting a delivery apparatus comprising a balloon through the prosthetic heart valve, the valve holder, and the aperture of the crimping device, and actuating the crimping device to reduce a diameter of the aperture, thereby crimping the prosthetic heart valve on the delivery apparatus.