Prosthetic Heart Valve Crimp Magnitude for Consistent Leaflet Compression
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Solution Overview
Problem
Existing methods of crimping prosthetic heart valves for transcatheter delivery can cause damage and increased calcification, and lack consistency and predictability in crimping uniformity, leading to potential complications during implantation.
Innovation Solution
Quantifying the crimp magnitude of prosthetic heart valves by calculating the ratio of uncompressed tissue leaflet size to available compressed volume, ensuring a crimp magnitude between 110% and 135%, and controlling the crimping process to prevent over-crimping, with automated or manual crimpers, to achieve consistent and predictable crimping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If the prosthetic heart valve is crimped to a small size for transcatheter delivery, then the valve can be delivered through a catheter in a minimally invasive procedure, but the valve may be damaged and calcification may increase
Solution Approach 1:
The patent applies parameter changes by defining specific crimp magnitude ranges (110%-135% of uncompressed diameter) and time thresholds (under 45 minutes) to optimize the crimping process. These quantitative parameters ensure the valve is sufficiently compressed for delivery while preventing damage and calcification through controlled compression extent and duration.
Solution Approach 2:
The patent implements feedback mechanisms by measuring the actual crimped diameter and calculating the crimp magnitude ratio, then comparing it against the target range. This allows real-time adjustment of crimping parameters to maintain valve integrity while achieving the required small size for catheter delivery.
2Manufacturing precision
If the prosthetic heart valve is crimped for a long time to ensure proper compression, then the valve achieves consistent crimping, but the valve may be damaged and calcification may increase
Solution Approach 1:
The patent establishes a maximum time threshold of 45 minutes for the crimping process. This time parameter, combined with the crimp magnitude range, ensures sufficient compression uniformity while preventing the prolonged compression that would lead to valve damage and calcification.
Solution Approach 2:
The patent uses feedback by monitoring both the crimped diameter and the time elapsed during crimping. The system compares actual measurements against target parameters and adjusts the crimping process accordingly, ensuring uniform compression is achieved within the safe time threshold to prevent calcification.
3Reliability
If the prosthetic heart valve is pre-crimped during manufacturing, then consistency and predictability are improved for end users, but the crimping uniformity may vary without proper control
Solution Approach 1:
The patent defines specific quantitative parameters for pre-crimping: crimp magnitude between 110%-135% of the uncompressed diameter and time under 45 minutes. These standardized parameters ensure consistent and predictable crimping across all pre-crimped valves while maintaining manufacturing precision through controlled compression.
Solution Approach 2:
The patent implements feedback control in the pre-crimping process by measuring the actual crimped dimensions, calculating the crimp magnitude ratio, and comparing it against the target range. This ensures each pre-crimped valve meets the specified uniformity standards, providing consistent and predictable performance for end users.
4Length of moving object
If the crimping force is increased to achieve smaller crimped size, then the valve fits better in the delivery catheter, but the valve tissue may be damaged
Solution Approach 1:
The patent changes the approach from maximizing compression force to controlling compression extent through the crimp magnitude parameter (110%-135%). This ensures the valve achieves sufficient size reduction for catheter fit while the quantitative limits prevent excessive force application that would damage valve tissue.
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 method reduces the risk of valve damage and calcification while ensuring consistent crimping, enhancing the predictability and reliability of prosthetic heart valve implantation procedures.
Implementation Method 1
the prosthetic heart valve may be crimped onto a delivery device so that the prosthetic heart valve has a crimped diameter that is smaller than the initial diameter
Data Source
AI summary
A method of implanting a prosthetic heart valve may include crimping the valve onto a delivery device from a larger initial diameter to a smaller crimped diameter. Before crimping, the prosthetic leaflets of the valve may be in an uncompressed condition, and after crimping, the prosthetic leaflets may be in a compressed condition. The prosthetic heart valve may be advanced through a patient's vasculature while crimped and then deployed into a valve annulus of the patient. After crimping the prosthetic heart valve form the initial diameter to the compressed diameter, the prosthetic heart valve may have a crimp magnitude of between 110% and 135%. The crimp magnitude may be calculated as a ratio of (i) a size of the prosthetic leaflets in the uncompressed condition to (ii) a total amount of available size that the prosthetic leaflets can occupy when the prosthetic leaflets are in the compressed condition.