Constraint Delivery Sleeve for Low-Force Lumen Insertion
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Solution Overview
Problem
Circulatory support devices with polymeric coatings face resistance during delivery through lumens due to their resistive nature, requiring high delivery forces that are undesirable.
Innovation Solution
A delivery device featuring a sleeve with a securement portion that can transition between constrained and expanded configurations, actuated by a tether assembly, to facilitate delivery and withdrawal of the device through a lumen, reducing the delivery force by constraining and unconstraining the deployment portion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a polymeric coating is applied to protect underlying components, then protection is improved, but delivery resistance increases
Solution Approach 1:
A delivery sleeve acts as an intermediary between the circulatory support device and the delivery lumen. The sleeve has a smooth exterior surface that reduces friction during delivery, while the device itself retains its protective polymeric coating. The sleeve temporarily encompasses the device during delivery and is then removed, allowing the device to maintain its protective coating without experiencing its negative effects on delivery resistance.
2Force
If a delivery sleeve is used to reduce delivery resistance, then delivery force is reduced, but device complexity increases
Solution Approach 1:
The delivery sleeve is constructed as a flexible, thin-walled structure that can be easily collapsed for delivery and then removed after deployment. This flexible shell design provides the smooth exterior surface needed to reduce delivery resistance while maintaining a relatively simple overall structure. The sleeve's flexibility allows it to conform to the device during delivery and be easily withdrawn after the device is deployed.
3Force
If the sleeve is constrained during delivery to reduce profile, then delivery is improved, but deployment requires additional actuation mechanisms
Solution Approach 1:
The delivery sleeve incorporates a dynamic securement portion that can transition between secured and unsecured states. During delivery, the securement portion is engaged to maintain the sleeve in a constrained configuration. After deployment, the securement portion is released, allowing the sleeve to expand and be removed. This dynamic transition allows the system to benefit from constraint during delivery while enabling easy release after deployment.
Data Source
AI summary
A method of delivering a medical device includes surrounding a deployment portion of the medical device with a sleeve that includes a sleeve wall and a securement portion positioned thereat and that is actuatable between secured and unsecured states, the sleeve configured to overlay the deployment portion to be delivered together with the deployment portion and to facilitate movement thereof through a delivery lumen during delivery of the medical device and configured to radially move between expanded and constrained configurations via actuation of the securement portion such that the sleeve is in the constrained configuration and the expanded configuration when the securement portion is in the secured and unsecured states respectively; inserting the deployment portion and sleeve together into a body lumen with the sleeve in the secured state; causing the sleeve to transition from the secured state to the unsecured state; and withdrawing the sleeve from the body lumen.