Peeling Sheath Reduces Deployment Force for Intraluminal Devices
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Solution Overview
Problem
Current endoprostheses and their delivery systems face challenges in providing a safe and effective treatment for aneurysms, including high mortality and morbidity rates, need for surgical intervention, and difficulties in positioning and anchoring devices in complex vascular geometries, while also requiring high deployment forces that can damage the devices and vessels.
Innovation Solution
A reduced deployment force delivery device featuring an inner tube and a concentric sheath with a peeling mechanism that inverts the inner layer to deploy stent-grafts or intraluminal devices, allowing for easier navigation through tortuous vessels and precise placement without embedding the device, using lubricious materials and tapered inner layers for smoother deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If conventional delivery systems are used to deploy intraluminal devices, then the devices can be delivered to the target site, but high deployment forces are required which can damage the devices and vessels
Solution Approach 1:
The delivery system is segmented into multiple functional components: an outer sheath, an inner tube, and a peeling layer. The peeling layer is further divided into a proximal portion and a distal portion with different properties. This segmentation allows each component to perform its specific function in reducing deployment force during device deployment.
Solution Approach 2:
The peeling layer undergoes parameter changes during deployment - it transitions from a state of being adhered to the inner tube to a peeled-off state. The proximal portion has different mechanical properties (higher adhesion) compared to the distal portion (lower adhesion), allowing controlled peeling that reduces the force required for device deployment while preventing device embedding.
2Length of moving object
If the delivery system profile is reduced for easier navigation through tortuous vessels, then navigation is improved, but device deployment becomes more difficult
Solution Approach 1:
The intraluminal device is nested within the inner tube, which is itself nested within the outer sheath. The peeling layer is integrated between the inner tube and outer sheath. This nested configuration allows the delivery system to maintain a compact profile for navigation while enabling controlled deployment through the peeling mechanism that reduces deployment forces.
Solution Approach 2:
The peeling layer is pre-configured in the delivery system with specific adhesion properties before deployment. The proximal portion is designed to adhere to the inner tube while the distal portion is designed to peel away easily. This preliminary configuration ensures that when deployment is initiated, the peeling action occurs automatically, reducing the force required without requiring additional operational steps.
3Force
If the inner layer is peeled away during sheath retraction to reduce deployment force, then deployment force is reduced, but the mechanism becomes more complex
Solution Approach 1:
The peeling layer is merged with both the inner tube and the outer sheath, creating a single integrated component that performs multiple functions. It provides adhesion to the inner tube during delivery, facilitates controlled peeling during deployment, and prevents device embedding. This merging reduces the number of separate components needed while achieving the desired force reduction.
Solution Approach 2:
The peeling layer serves multiple functions: it adheres to the inner tube during delivery, peels away during deployment to reduce force, and prevents the device from embedding in the sheath. By making this single component universal and multi-functional, the overall system complexity is minimized while achieving the force reduction goal.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution reduces the risk of device damage and vessel injury, enables precise deployment in complex anatomies, and minimizes the need for surgical intervention by lowering the profile of the delivery system, thereby improving safety and efficacy in treating aneurysms.
Implementation Method 1
A lubricious material may be provided between the inner and outer layers to render movement thereof easier
Implementation Method 2
The inner layer may taper from its proximal end to its distal end so as to become larger at its distal end
Data Source
AI summary
A reduced deployment force delivery apparatus having an outer sheath with two layers that move relative to one another so as to reduce the deployment force necessary for deploying a stent, stent graft or other intraluminal device.