Heart Valve Prosthesis Funnel Crimping for Uniform Sheath Loading
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Solution Overview
Problem
Current crimping techniques for heart valve prostheses are inefficient in achieving uniform and controlled compression necessary for minimally invasive delivery, as they do not effectively reduce the prosthesis diameter to match the delivery device's sheath, leading to challenges in loading and deployment.
Innovation Solution
A system comprising a first and second funnel with tapered sections and a split step mechanism, along with a puller tube and actuator, allows for controlled crimping of the valve prosthesis by advancing it through a series of funnels and barrels to match the outer sheath's diameter, enabling precise loading onto a delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If standard crimping methods are used to compress the valve prosthesis, then the prosthesis can be compressed to some extent, but uniform and controlled compression to match the delivery device sheath diameter cannot be achieved
Solution Approach 1:
The crimping process is divided into multiple sequential stages using a series of funnels with progressively smaller diameters (first funnel, second funnel, third funnel) and intermediate barrels. Each funnel stage applies controlled compression to progressively reduce the prosthesis diameter, transforming a single difficult crimping operation into multiple manageable stages that achieve uniform compression matching the delivery device sheath diameter.
Solution Approach 2:
Instead of compressing the prosthesis directly onto the delivery device, the invention uses funnels that taper inward to guide and compress the prosthesis from a larger diameter state to a smaller diameter state. The funnels are positioned over the prosthesis and the delivery device is advanced into the funnel, reversing the traditional approach where the prosthesis would be forced directly onto the device.
2Ease of operation
If the prosthesis diameter is not reduced to match the outer sheath, then the crimping process is simpler, but loading onto the delivery device becomes impossible or highly problematic
Solution Approach 1:
The crimping system uses a nested structure where funnels are positioned over barrels, which are in turn positioned over the delivery device. The first funnel has a larger diameter than the second funnel, which has a larger diameter than the third funnel, creating a nested sequence of progressively smaller components. This nested arrangement allows systematic compression of the prosthesis through multiple stages while keeping the overall system organized and manageable.
Solution Approach 2:
The funnels and barrels serve as intermediary components between the crimping force and the prosthesis. Rather than applying compression directly, the tapered surfaces of the funnels act as mediators that gradually compress the prosthesis frames while guiding them into the correct position on the delivery device. The barrels provide intermediate support and positioning during the transition between funnel stages.
Data Source
AI summary
Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.