Vascular Plug With Flexible Sheet For Occlusion
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Solution Overview
Problem
Current methods for occluding vascular vessels lack effective and versatile devices that can efficiently block fluid flow, particularly in treating aneurysms and AV fistulas, as existing technologies are inadequate in terms of durability and deployment mechanisms.
Innovation Solution
The development of a device comprising a frame and a flexible sheet material coupled with an expandable occluding material, which can transition from a compact state for transluminal delivery to an expanded state within the vascular vessel, effectively blocking fluid flow by positioning the sheet material across the vessel lumen and contacting inner wall surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a vascular occlusion device is designed with a large expanded size to effectively block fluid flow, then occlusion effectiveness is improved, but the device cannot be delivered through small vascular vessels
Solution Approach 1:
The frame is designed to be dynamically changeable between a compressed configuration for delivery and an expanded configuration for occlusion. The frame comprises multiple elongate arms that can be compressed together for delivery through catheters and then expanded at the target site to provide effective occlusion.
Solution Approach 2:
The device structure allows the elongate arms to nest within each other during compression, enabling the large expanded device to be delivered through small catheters. The arms are arranged to telescope or fold into one another, reducing the delivery profile while maintaining the expanded occlusion capability.
2Strength
If the frame is made rigid to provide structural support for occlusion, then structural stability is improved, but the device cannot be compressed for delivery
Solution Approach 1:
The frame utilizes shape memory alloy or elastic materials that can be deformed for delivery and then return to their original rigid configuration at the target site. This dynamic property allows the frame to be both compressible during delivery and rigid during occlusion.
Solution Approach 2:
The mechanical properties of the frame material are changed between delivery and deployment phases. The frame material transitions from a flexible, compressible state during delivery to a rigid, supportive state during occlusion, achieving both requirements through parameter change.
3Strength
If the occluding material is placed inside the frame for protection, then material protection is improved, but the material cannot effectively contact vessel walls
Solution Approach 1:
The frame structure is designed with selective openness, providing protection for the occluding material in certain regions while leaving other regions open to allow the material to contact the vessel wall. This local differentiation of protection versus contact enables both functions to coexist.
Solution Approach 2:
The frame is divided into multiple segments or sections, with some portions providing protective enclosure for the occluding material and other portions designed to be open or transparent to allow material-vessel wall contact for effective occlusion.
4Reliability
If the device is designed for complete vessel occlusion, then occlusion effectiveness is improved, but the device lacks versatility for different vessel sizes and conditions
Solution Approach 1:
The device is designed with adjustable parameters including frame size, arm configuration, and occluding material quantity that can be modified to accommodate different vessel diameters and occlusion requirements. This multi-functionality allows the same basic device design to serve multiple clinical indications.
Solution Approach 2:
The device incorporates variable parameters such as frame diameter, arm length, and material volume that can be changed to adapt the device to different vessel sizes and occlusion needs, providing versatility across multiple applications while maintaining effective occlusion.
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 device provides a reliable and durable occlusion by fully or partially blocking fluid flow, anchoring the occluding material, and promoting tissue ingrowth, thereby effectively treating vascular malformations and anomalies.
Implementation Method 1
an expandable occluding material that is located in an interior region of the frame and that is effective to volumetrically expand at the vascular site so as to provide a volumetrically expanded material at the vascular site
Implementation Method 2
The frame is movable between a first condition that is suitable for transluminal vascular delivery to a vascular site for providing an occluding device, and an expanded second condition that is adapted for deployment at the vascular site
Implementation Method 3
The flexible sheet material is coupled to the frame such that when the frame moves from the first condition to the expanded second condition at the vascular site, the sheet material is drawn across at least part of the vascular or other vessel lumen
Data Source
AI summary
Certain aspects of the present invention provide devices for occluding vascular vessels. In some preferred forms, these devices are able to move from a first condition to a less compact, second condition in a vascular vessel so as to fully or partially prevent fluid from passing through the vessel. One such device includes a frame and a flexible sheet material. The device also includes an occluding material that is located in an interior region of the frame. The flexible sheet material and frame are associated with one another such that when the device is in the second condition in the vascular vessel, the sheet material is positioned in the vessel lumen so as to block fluid flow through the lumen.