Heart Valve Prosthesis Loading Tool with Pulling Suture
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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, particularly when dealing with different stent materials and structures, leading to asymmetrical crimping and potential damage during deployment.
Innovation Solution
A crimping and loading device comprising a funnel, a tubular structure, and a pulling suture system that allows for symmetrical crimping and loading of stent-based prostheses by connecting the stent to a pulling suture, pulling it through a funnel into the tubular structure, and advancing the catheter shaft over the stent, while the sutures are cut and removed to maintain the crimped state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a radial crimper is used to crimp a braided Nitinol stent, then the stent can be compressed radially, but the stent expands again when the force is released and cannot be maintained in a crimped state
Solution Approach 1:
The patent applies preliminary action by first crimping the stent using a radial crimper to reduce its diameter, then immediately securing it in the crimped state using a delivery system shaft and catheter assembly before the stent can expand again. This sequence of pre-planned actions ensures the stent remains compressed during loading and deployment.
2Ease of operation
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, inducing damage to the braided structure
Solution Approach 1:
The patent uses a delivery system shaft and catheter assembly as an intermediary mechanism to load the stent onto the delivery system without applying direct longitudinal force through a funnel. The shaft and catheter gently guide and secure the crimped stent, avoiding compression damage to the braided structure while achieving proper loading.
3Productivity
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 preliminary action by first crimping the stent to reduce its diameter, then immediately securing it in the crimped state using a delivery system shaft and catheter assembly before the stent can expand again. This sequence of pre-planned actions ensures the stent remains compressed during loading and deployment.
Solution Approach 2:
The patent uses a delivery system shaft and catheter assembly as an intermediary mechanism to load the stent onto the delivery system without applying direct longitudinal force through a funnel. The shaft and catheter gently guide and secure the crimped stent, avoiding compression damage to the braided structure while achieving proper loading.
4Adaptability or versatility
If different stent materials or structures with different diameters or thickness dimensions are used, then the prosthesis can be adapted to different applications, but achieving symmetrical crimping and loading becomes difficult
Solution Approach 1:
The patent employs a delivery system shaft and catheter assembly that can accommodate and secure various stent materials, structures, diameters, and thickness dimensions. This universal design allows symmetrical crimping and loading of different prosthesis types without requiring material-specific adjustments, achieving both versatility and manufacturing precision.
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.