Expandable Implant Delivery System with Constraining Sleeve
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Solution Overview
Problem
Existing implantable medical devices face challenges in maneuverability and positioning within the vasculature of patients, necessitating improved deployment and orientation mechanisms.
Innovation Solution
A catheter assembly with a constraining sleeve and line system is used to maintain an expandable implant, such as a stent-graft, in a desired orientation and position, allowing for improved maneuverability and deployment characteristics by constraining the implant in a collapsed configuration for delivery and expanding it to a functional diameter at the treatment site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the implant is delivered in a collapsed configuration through the vasculature, then the device can be navigated to the treatment area, but the device lacks maneuverability and precise positioning capability
Solution Approach 1:
The delivery system is divided into distinct functional segments: a catheter for navigation, a constraining sleeve for maintaining collapsed configuration, and a deployment mechanism for expansion. This segmentation allows each component to perform its specific function optimally while working together as an integrated system.
Solution Approach 2:
The constraining sleeve acts as an intermediary element between the implant and the delivery catheter. It maintains the implant in a collapsed configuration during navigation through the vasculature, enabling safe delivery while preserving the implant's structural integrity. The sleeve is subsequently removed to allow deployment.
2Measurement precision
If the implant is constrained in a collapsed configuration for delivery, then the device can be delivered through the vasculature, but the device cannot be properly oriented or positioned at the treatment site
Solution Approach 1:
The implant is pre-loaded onto the delivery catheter in a collapsed configuration within the constraining sleeve before patient administration. This preliminary preparation ensures the implant is ready for immediate deployment upon reaching the treatment site, eliminating the need for complex assembly procedures in vivo.
Solution Approach 2:
The delivery system transitions from a static constrained state during delivery to a dynamic deployable state at the treatment site. The constraining sleeve can be removed or expanded, allowing the implant to transition from a fixed collapsed configuration to an expandable functional configuration, providing maneuverability when needed.
3Reliability
If the implant is expanded at the treatment site, then the device provides therapeutic function, but tissue damage may occur during expansion
Solution Approach 1:
The constraining sleeve protects the surrounding tissue during the delivery and deployment process by containing the implant in a compact configuration. The sleeve prevents the implant from inadvertently contacting or damaging vasculature walls during navigation, and controls the expansion process to minimize tissue disruption.
Solution Approach 2:
The delivery system is designed to ensure smooth, controlled expansion of the implant at the treatment site. The catheter and constraining sleeve are positioned to guide the expansion process, cushioning the transition from collapsed to expanded state and preventing sudden movements that could cause tissue damage.
Data Source
AI summary
The present disclosure describes medical devices comprising implantable expandable implants, such as stent-grafts. Such devices can comprise a constraining line. The constraining line can surround the proximal end of the expandable implant, and assist in positioning and deployment of the expandable implant within the body of the patient.