Heart Valve Prosthesis Loading Tool with Pulling Suture System
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Solution Overview
Problem
Current crimping and loading tools for heart valve prostheses with braided Nitinol stents face challenges in maintaining a crimped state without damaging the stent or the tissue valve, achieving symmetrical crimping, and accommodating different stent materials and structures, particularly when using self-expanding stents.
Innovation Solution
A crimping and loading device comprising a funnel, a tubular structure, and a pulling suture system that allows for the stent to be pulled into the tubular structure using a rotatable wheel and sutures, maintaining the crimped state without relying on radial compression, and enabling symmetrical crimping and loading onto a catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a radial crimper is used to crimp a braided Nitinol stent, then the stent can be compressed to a smaller diameter, but the stent expands again when the crimper force is released
Solution Approach 1:
The patent applies preliminary action by pre-compressing the self-expanding nitinol stent within the delivery system catheter before implantation. The stent is crimped to a compressed state and maintained in this state through the delivery system, then deployed at the target site where it expands to its natural self-expanding diameter. This preliminary compression allows the stent to be delivered through the catheter while maintaining structural integrity, and the self-expanding property ensures stable deployment at the destination without requiring continuous external compression force.
2Length of moving object
If longitudinal force is applied to push a braided stent through a funnel, then the stent can be loaded onto the delivery system, but the stent gets compressed longitudinally rather than advanced
Solution Approach 1:
The patent inverts the traditional loading approach by having the stent self-expand within the delivery system rather than forcing it through compression. The stent is positioned in an expanded state or partially expanded state within the catheter, and the delivery system is designed to accommodate and control the stent's natural expansion. This inversion eliminates the need for longitudinal compression forces that would damage the braided structure, while still achieving proper loading and positioning onto the delivery system.
3Ease of manufacture
If forces are applied to crimp and load the stent onto the delivery system, then the prosthesis can be loaded, but the tissue of the replacement valve may be damaged
Solution Approach 1:
The patent applies parameter changes by controlling the expansion and compression parameters of the stent during loading and deployment. The stent is maintained in a compressed state with controlled radial and longitudinal parameters during delivery, then transitions to an expanded state with different parameters at the target site. This controlled parameter transformation allows the prosthesis to be loaded onto the delivery system without excessive forces that would damage the tissue valve, while ensuring proper deployment functionality at the implantation site.
4Adaptability or versatility
If different stent materials or structures with different diameters or thickness dimensions are used, then design flexibility is improved, but crimping and loading becomes more difficult
Solution Approach 1:
The patent applies universality by designing a delivery system and crimping mechanism that can accommodate multiple stent materials, structures, diameters, and thickness dimensions through a single standardized platform. The delivery system incorporates adjustable parameters and universal interfaces that adapt to different stent configurations without requiring separate specialized equipment for each stent type. This multi-functional design simplifies the crimping and loading process across diverse stent materials and structures while maintaining design flexibility for different clinical applications.
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
The solution effectively crimps and loads braided stent-based prostheses with minimal damage, ensuring symmetrical deployment and compatibility with various stent materials, reducing the risk of tissue damage and improving the crimping process for different stent characteristics.
Implementation Method 1
at least one pulling suture (105) releasably attached or in a manner that it can be deconnected, e.g. cut, to the stent or stent-based prosthesis
Data Source
AI summary
The present invention relates to a heart valve prosthesis loading device and a method for loading a heart valve prosthesis onto a delivery system.