On-Device Constraining Mechanism for Implantable Medical Devices
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Solution Overview
Problem
Existing constraining mechanisms for implantable medical devices, such as stents and stent-grafts, require additional manufacturing steps and can lead to errors or damage during device loading, as they are formed as separate components and applied after the device is reduced to a delivery diameter.
Innovation Solution
The constraining mechanism is formed directly on the implantable medical device by interlocking fibers, such as knitting or braiding, while the device is in a reduced diameter configuration, thereby reducing manufacturing steps and minimizing the risk of device damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If constraining mechanisms are formed as separate components and applied after device reduction, then the device can be manufactured with standard processes, but additional manufacturing steps are required and errors or damage can occur during loading
Solution Approach 1:
The constraining mechanism is merged with the implantable medical device by forming it directly on the device during the manufacturing process. The fiber reinforcement structure is integrated into the device wall, eliminating the need for separate application steps and reducing the risk of loading errors while maintaining manufacturability through continuous processing
Solution Approach 2:
The constraining mechanism is formed preliminarily during the device manufacturing process before the device is reduced to delivery configuration. By pre-integrating the fiber reinforcement structure into the device wall, the system eliminates subsequent loading steps that could cause errors or damage, while the device maintains its constrained configuration until deployment
2Ease of operation
If constraining mechanisms are applied after device reduction, then the device can be loaded into delivery system, but the constraint may not be tight enough and device expansion may occur during loading
Solution Approach 1:
The constraining mechanism is merged with the implantable medical device by forming it directly on the device during the manufacturing process. The fiber reinforcement structure is integrated into the device wall, eliminating the need for separate application steps and reducing the risk of loading errors while maintaining manufacturability through continuous processing
Solution Approach 2:
The constraining mechanism is formed preliminarily during the device manufacturing process before the device is reduced to delivery configuration. By pre-integrating the fiber reinforcement structure into the device wall, the system eliminates subsequent loading steps that could cause errors or damage, while the device maintains its constrained configuration until deployment
Data Source
Figure 1
Figure 2A~2B
Figure 3A
AI summary
Various aspects of the present disclosure are directed apparatuses, systems and methods that include forming a constraining mechanism for an implantable medical device delivery. The apparatuses, systems and methods may include reducing a diameter of the implantable medical from a deployed diameter to a reduced diameter and interlocking one or more fibers along a length of the implantable medical device while the implantable medical device is in the reduced diameter to form the constraining mechanism.