Expandable Vessel Occlusion Device with Flow-Limiting Valve
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Solution Overview
Problem
Existing vessel occlusion methods, such as balloon occlusion devices, face challenges including spontaneous deflation, difficulty in navigating tortuous vessels, premature detachment, and limited precision, leading to risks like stroke and distal clot migration, with recent alternatives like hydrogel-coated coils and the Amplatzer Vascular Plug also having limitations.
Innovation Solution
A medical device featuring an expandable member with a flow-limiting valve that can be precisely placed and deployed, using a guide wire for navigation, and incorporating bioactive agents for thrombus formation and stabilization, ensuring acute and stable occlusion without the risks of deflation or migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If balloon occlusion devices are used to block vessels, then vessel occlusion can be achieved, but the balloons may spontaneously deflate over time leading to treatment failure
Solution Approach 1:
The patent changes the material parameter from elastic balloon material to shape memory alloy (Nitinol), which transforms from a deflatable elastic structure to a permanently deformable metallic structure that maintains its occlusive shape indefinitely in the deployed state
Solution Approach 2:
The device combines Nitinol shape memory alloy with hydrogel coating and embolic agents to create a composite structure that provides both mechanical occlusion and biological thrombus formation, ensuring long-term reliability
2Ease of operation
If detachable balloons are used for vessel occlusion, then the procedure can be performed, but premature detachment can cause cerebral artery blockage and stroke
Solution Approach 1:
The device is designed with a non-detachable structure that remains securely attached to the delivery catheter throughout navigation and positioning, with detachment or release only occurring after proper placement is confirmed, eliminating premature detachment risks
Solution Approach 2:
The delivery catheter acts as an intermediary that maintains secure connection between the occlusion device and the operator throughout the procedure, allowing controlled deployment only at the intended site
3Manufacturing precision
If balloons are inflated to occlude vessels, then vessel blockage can be achieved, but the balloons typically move forward during inflation making precise positioning difficult
Solution Approach 1:
The occlusion device is pre-formed in its expanded occlusive configuration before delivery, so it assumes its final stable shape immediately upon deployment at the target site, eliminating positioning drift during inflation
Solution Approach 2:
Instead of expanding a collapsed balloon to achieve occlusion, the device is delivered in a compressed state and then deployed to expand into its pre-determined occlusive shape, reversing the traditional approach to eliminate positioning errors
4Reliability
If hydrogel-coated coils are used for vascular occlusion, then clot formation can be induced, but there is a significant delay between placement and clot formation allowing distal clot migration
Solution Approach 1:
The device merges immediate mechanical occlusion through the Nitinol structure with accelerated thrombus formation through hydrogel coating and embolic agents, achieving both instant physical blockage and rapid biological clotting to prevent migration
Solution Approach 2:
The hydrogel coating and embolic agents are pre-applied to the device before implantation, so thrombus formation begins immediately upon contact with blood at the implantation site, eliminating the time delay for clot development
5Reliability
If the Amplatzer Vascular Plug is used for vessel occlusion, then flow blockage can be achieved, but the device lacks navigability through tortuous vessels
Solution Approach 1:
The delivery catheter and occlusion device are designed with dynamic flexibility allowing them to conform to and navigate tortuous vessel paths, while the deployed device maintains static stability for reliable occlusion at the target site
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 effective and stable vessel occlusion with improved precision and safety, reducing the risk of clot migration and allowing for immediate occlusion, thus addressing the limitations of prior methods.
Implementation Method 1
the valve being movable between an open and a closed configuration; and wherein, when in the closed configuration and placed in the lumen of the body cavity, the valve substantially prevents a flow of a fluid in the lumen of the body cavity past the flow-limiting member
Implementation Method 2
an expandable member having a lumen passing therethrough, the expandable member comprising first and second ends; the expandable member expandable from a first conformation to a second conformation; wherein, when the expandable member is in the second conformation, the device engages a surface of the body cavity
Implementation Method 3
incorporating bioactive agents for thrombus formation and stabilization
Data Source
AI summary
An occluding device including expandable scaffold and a flow-limiting member is described. In some embodiments the scaffold is an expandable or self-expanding stent deliverable over a guide wire. The flow-limiting member can include a valve that can be closed following deployment. On deployment the stent and flow-limiting member can engage an inner surface of a body cavity lumen, blocking flow of material. In some embodiments the body cavity is a blood vessel, and the device can be used to block blood flow. In some embodiments the device includes bioactive agents.