Prosthetic Valve Crimping Accessory for Symmetrical Leaflet Protection
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Solution Overview
Problem
Existing crimping apparatuses for prosthetic valves can damage valve leaflets or deform components during the crimping process due to direct contact with metal struts, leading to asymmetrical crimping and potential functional issues.
Innovation Solution
A crimping accessory device with axially-extending fingers is inserted between the leaflets and the frame of the prosthetic valve, shielding the leaflets from direct contact with the metal struts and maintaining symmetrical crimping, thereby reducing damage and ensuring uniform folding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a crimping apparatus is used to reduce the diameter of the prosthetic valve, then the valve can be delivered to the treatment site, but the leaflets may become damaged by contacting the metal stent
Solution Approach 1:
A crimping accessory device with circumferentially arranged fingers is introduced as an intermediary between the crimping apparatus and the prosthetic valve. The fingers contact the outer surface of the valve frame and transmit crimping forces while preventing direct contact between the metal stent and leaflets, thereby eliminating the harmful effect of leaflet damage during crimping
Solution Approach 2:
The crimping accessory device is positioned on the prosthetic valve before the crimping process begins. The fingers are pre-positioned to engage with the valve frame, establishing a protective interface in advance that prevents leaflet contact with metal struts during the subsequent diameter reduction
2Productivity
If the diameter of the prosthetic valve is reduced during crimping, then the valve can be inserted into the delivery catheter, but components of the prosthetic valve may be deformed
Solution Approach 1:
The crimping accessory device serves as a mediator that distributes crimping forces uniformly across the valve frame through its circumferentially arranged fingers. This intermediate structure prevents concentrated stresses that could deform components while still enabling the necessary diameter reduction for catheter insertion
Solution Approach 2:
The crimping accessory device controls the diameter reduction process by gradually decreasing the internal diameter of the valve through controlled finger movement. This controlled parameter change ensures uniform compression without exceeding deformation thresholds for valve components
3Device complexity
If the prosthetic valve is crimped without protection, then the crimping process is simple, but the leaflets may contact the metal struts and become damaged
Solution Approach 1:
The crimping accessory device with its circumferential fingers acts as a protective intermediary layer between the metal stent and leaflets. This addition slightly increases device complexity but significantly improves reliability by preventing direct contact and potential damage during the crimping operation
Data Source
Figure 1
Figure 2A
Figure 2B
AI summary
Embodiments are provided of an assembly having a prosthetic valve, the prosthetic valve having a radially expandable and compressible annular frame, and a crimping accessory device, and methods for using the assembly in compressing the prosthetic valve. The frame includes an outer surface and an inner surface. A leaflet assembly is supported inside the annular frame. The leaflet assembly includes a plurality of leaflets, each having an inner surface and an outer surface. The crimping accessory device has a plurality of axially-extending fingers. At least a first finger of the plurality of fingers is disposed between the outer surface of a first leaflet of the plurality of leaflets, and at least a second finger of the plurality of fingers is disposed radially- inwardly of the inner surface of the first leaflet.