Guide System for Implantable Device Crimp Loading
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Solution Overview
Problem
Traditional surgical procedures for implanting prosthetic heart valves cause significant patient trauma and discomfort, while minimally-invasive techniques risk damaging the implantable medical device during crimping due to potential contact with the delivery system components.
Innovation Solution
A guide system is used to protect the implantable medical device by providing a conduit for the delivery system, minimizing contact and orienting components like leaflets to prevent damage during compression and loading processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the delivery system is inserted into the partially crimped implantable medical device during the crimp process, then the crimping operation can be performed to load the device onto the delivery system, but the risk of damaging the implantable medical device or delivery system increases due to crowding and packing of components
Solution Approach 1:
A guide system is introduced as an intermediary component between the delivery system and the implantable medical device. The guide system includes a guide body that fits within the implantable medical device and a guide catheter that is inserted through the guide body, creating a protected pathway. This intermediary structure allows the delivery system to be inserted without directly contacting and damaging the delicate components of the implantable medical device, such as leaflet material, while still enabling the crimping operation to proceed.
2Ease of operation
If the crimping process is performed to load the implantable medical device onto the delivery system, then the device can be delivered minimally-invasively, but the components of the implantable medical device may be damaged due to crowding and packing
Solution Approach 1:
The guide system serves as a protective intermediary that enables minimally-invasive delivery while protecting the integrity of the implantable medical device components. The guide body and guide catheter create a controlled pathway that allows the delivery system to access the implantable medical device without causing damage to delicate components like leaflet material during the crimping process.
Solution Approach 2:
The guide system is inserted into the implantable medical device before the crimping operation begins. This preliminary action establishes a protected pathway and orientation framework that prevents damage to components during the subsequent crimping process, allowing the delivery system to be safely introduced without risking damage to the implantable medical device.
3Ease of manufacture
If the delivery system components contact the implantable medical device during insertion, then the loading process can be completed, but damage may occur to the implantable medical device or delivery system
Solution Approach 1:
The guide system acts as a protective intermediary layer between the delivery system components and the implantable medical device during the loading process. The guide body and guide catheter create a controlled interface that allows the delivery system to be inserted and the loading process to be completed without direct contact between harmful components, thereby preventing damage to either the implantable medical device or the delivery system.
Data Source
AI summary
A system for assisting in loading an implantable medical device onto a delivery system includes a body having a first end, a second end, and a conduit extending from the first end to the second end. The body has an inner diameter that allows a distal portion of the delivery system to slidably move through the conduit. The body has an outer diameter that allows the body to be inserted into a central lumen of the implantable medical device.