Iris Jaw Crimper for Uniform THV Diameter Reduction
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Solution Overview
Problem
Current crimping technologies for trans-catheter prosthetic heart valves (THVs) face challenges in uniformly reducing the diameter of large devices like THVs from 32 mm to 6 mm without inducing high mechanical stresses, and existing crimpers are not optimized for cost-effective manufacturing and simple operation.
Innovation Solution
A crimper with a mechanism involving a base plate, stopper, side plates, housing plates, jaws, guide plates, gear rings, and gear pins that synchronously move to form an iris opening, allowing for controlled crimping through rotational and linear movements, ensuring uniform pressure and preventing over-crimping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a crimper with multiple jaws is used to reduce the diameter of large THVs, then the crimping capability is improved, but the device complexity increases
Solution Approach 1:
The crimper is divided into multiple independent jaws (typically 6-12 jaws) that can move independently or in coordinated fashion. Each jaw can be adjusted individually to apply pressure on different segments of the THV, enabling effective crimping of large diameter devices while maintaining manageable complexity through modular design
Solution Approach 2:
The crimper incorporates a dynamic mechanism that allows the jaws to move from an open position to a closed crimping position. The jaws can be adjusted radially to match the specific diameter of different THV sizes, providing adaptability without requiring multiple fixed-size crimpers, thus improving productivity while controlling complexity through a single adjustable device
2Manufacturing precision
If uniform pressure is applied during crimping, then the manufacturing precision is improved, but the device complexity increases
Solution Approach 1:
Multiple jaws are combined into a single integrated crimper assembly that operates simultaneously. The jaws are positioned equidistantly around the central axis and move in a coordinated manner to apply uniform radial pressure on the THV, ensuring even crimping without requiring separate operations for each jaw, thus achieving manufacturing precision without excessive complexity
Solution Approach 2:
The crimper design ensures that all jaws are at equivalent positions relative to the central axis and apply equal force during crimping. The mechanical linkage or actuation system maintains equipotential conditions where each jaw experiences the same operational parameters, guaranteeing uniform pressure distribution across the THV surface while using a symmetric, relatively simple mechanical structure
3Productivity
If the crimping force is increased to reduce diameter effectively, then the productivity is improved, but the object-affected harmful factors increase
Solution Approach 1:
The jaws are designed with localized contact surfaces that distribute the crimping force across multiple points around the THV circumference. Each jaw applies pressure at a specific location, and the combined effect of multiple jaws distributes the total force uniformly, preventing concentration of stress at any single point that could cause damage to the prosthesis while maintaining overall crimping efficiency
Solution Approach 2:
The crimper applies crimping force in a controlled, progressive manner rather than as a single excessive force. The jaws can be adjusted to apply incremental pressure, and the process can be paused or reversed if needed, allowing effective diameter reduction while avoiding excessive force that could damage the prosthesis structure
4Manufacturing precision
If the number of jaws is increased to form a smoother circular opening, then the manufacturing precision is improved, but the device complexity and cost increase
Solution Approach 1:
The crimper is designed as a universal device that can accommodate various THV diameters and sizes by adjusting the jaw positions rather than requiring different numbers of jaws for different applications. The same set of jaws (typically 6-12) can be configured to crimp different sized valves, providing multi-functionality that reduces the need for multiple specialized crimpers, thereby controlling manufacturing cost while achieving sufficient circular smoothness
Data Source
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.