Synchronized THV Crimper Jaws for Uniform Radial Collapse
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Solution Overview
Problem
Existing crimpers for trans-catheter prosthetic heart valves (THVs) face challenges in uniformly reducing the diameter of large prosthetic devices without inducing mechanical stress, while ensuring secure attachment to the balloon catheter to prevent dislodgment and damage, and allowing for controlled crimping to avoid over-crimping.
Innovation Solution
A crimper apparatus with synchronized jaw movement, utilizing gears and threads, and adjustable stoppers to achieve uniform crimping of THVs, allowing for single-stage or multi-stage crimping operations, and preventing over-crimping by setting a minimum iris opening size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the number of jaws is increased to form a smoother circular opening, then the shape precision of the opening is improved, but the device complexity increases
Solution Approach 1:
The crimper divides the crimping function into multiple independent jaws (typically 6-12 jaws) that can be individually positioned and controlled. Each jaw acts as a separate segment that collectively forms the circular opening, allowing smooth crimping without requiring an excessive number of components
Solution Approach 2:
Multiple jaws are merged into a single synchronized mechanism where all jaws move simultaneously and uniformly during the crimping process. This merging allows the system to achieve the effect of a smooth circular opening while maintaining manageable device complexity through coordinated motion
2Reliability
If the crimping force is increased to securely attach the device to the balloon, then the reliability of attachment is improved, but the risk of damage to the device and balloon increases
Solution Approach 1:
The crimper incorporates adjustable parameters including crimping force control, crimping speed control, and minimum iris opening size control. These parameter adjustments allow the system to apply sufficient force for secure attachment while preventing excessive force that could cause damage to the device or balloon
Solution Approach 2:
The synchronized movement mechanism provides feedback control where the position and movement of each jaw is coordinated to ensure uniform compression. This feedback system prevents localized over-compression and distributes the crimping force evenly, securing attachment while minimizing damage risk
3Productivity
If the crimping is performed in a single stage to improve productivity, then the productivity is improved, but the control precision may be compromised
Solution Approach 1:
The crimper employs dynamic control where the crimping process can be adjusted during operation. The synchronized jaws can modify their movement pattern, speed, and force application in real-time, allowing a single-stage process to achieve both high productivity and precise control through adaptive motion control
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
Ensures secure attachment of THVs to the balloon catheter, prevents dislodgment, and minimizes mechanical stress, while allowing for precise control of crimping diameter, thereby reducing the risk of damage to the device and balloon.
Implementation Method 1
The synchronized movement of the jaws is achieved by a mechanism including a gear ring and a plurality of gear pins
Implementation Method 2
Each jaw is provided with a hole having internal threads and the pin portion of the gear pin has external threads that are engaged to the internal threads of the hole in the jaw
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.