Synchronized Iris Crimper for Uniform THV Diameter Reduction
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Solution Overview
Problem
Existing crimpers for trans-catheter prosthetic heart valves (THVs) struggle to uniformly reduce the diameter of large prosthetic devices without inducing mechanical stress, risking damage to the device or balloon, and lack efficient, cost-effective multi-stage crimping capabilities.
Innovation Solution
A crimper with synchronized jaw movement and gear mechanism, featuring a base plate, stoppers, and gear pins, allows for uniform crimping and adjustable iris opening control, enabling single- or multi-stage diameter reduction of prosthetic devices up to 32 mm.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a traditional crimper with fixed jaw movement is used, then the crimping process is simple, but the pressure distribution is non-uniform causing device distortion
Solution Approach 1:
The patent implements a synchronized jaw movement mechanism where multiple jaws move dynamically in coordination to maintain uniform pressure distribution during crimping. The jaws are coupled through a common drive mechanism that ensures they move simultaneously and uniformly, transforming the static fixed-jaw design into a dynamic synchronized system that adapts to the prosthetic device geometry.
Solution Approach 2:
The crimper is divided into multiple independent jaws (typically 6-12 jaws) distributed around the circumference, each capable of independent movement but synchronized through the coupling mechanism. This segmentation allows localized pressure application while maintaining overall uniformity, and enables multi-stage crimping where different jaw groups can operate at different stages.
2Productivity
If the crimping force is increased to reduce diameter faster, then productivity improves, but mechanical stress on the device and balloon increases risking damage
Solution Approach 1:
The patent enables multi-stage crimping where the diameter reduction is achieved in progressive steps rather than a single excessive force application. The synchronized jaws can be positioned at different stages of closure, allowing the operator to apply partial crimping forces in sequence. This prevents any single stage from applying excessive stress that could damage the device or balloon, while still achieving the required diameter reduction through cumulative action.
3Manufacturing precision
If the number of jaws is increased to improve pressure uniformity, then manufacturing precision improves, but device complexity and cost increase
Solution Approach 1:
The synchronized jaw mechanism serves multiple functions: it provides uniform pressure distribution, enables multi-stage crimping, allows for different crimping patterns (single-stage or progressive), and can accommodate different prosthetic device sizes. This multi-functionality justifies the increased complexity by providing versatile capabilities that a simpler fixed-jaw design cannot achieve.
4Adaptability or versatility
If the crimping process is made adjustable for multi-stage operation, then adaptability improves, but ease of operation deteriorates
Solution Approach 1:
The synchronized jaw mechanism with common coupling provides self-synchronization, meaning the jaws automatically move in unison without requiring complex control systems or manual coordination. The operator simply activates the drive mechanism, and the coupled jaws self-regulate their movement to maintain uniform pressure and synchronized positioning, reducing the operational burden despite the enhanced functionality.
Data Source
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AI summary
A device and method of radially collapsing a medical device is disclosed. The device is in the form of an improved crimper which is capable of crimping a medical device. The crimper includes without limitation one or more of, a base plate, a stopper, two side plates, two housing plates with a handle, a plurality of jaws, two guide plates, at least one gear ring and a plurality of gear pins. The jaws, when assembled, collectively form an iris opening. The assembly of the crimper has a central opening through which the iris opening can be accessed. The device to be crimped is introduced in the central opening and held within the iris opening. The crimping is achieved by reducing the size of the iris opening (by moving the jaws simultaneously with respect to each other in synchronized manner) which in turn reduces the diameter of the prosthetic device.