Fibrin-Coated Nitinol Stent for Vascular Thrombosis
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Solution Overview
Problem
Current medical devices used for vascular diseases, such as stents and flow diverters, made of foreign materials can cause thrombosis and vessel occlusion, leading to complications like stroke, and anticoagulant medications used to prevent thrombosis have side effects and impair endothelialization.
Innovation Solution
A self-expanding medical device with a durable antithrombogenic and endothelialisation-promoting fibrin coating, formed from nickel-titanium alloy, which is designed to prevent thrombus formation until a natural endothelium is established, reducing the need for anticoagulant medications and minimizing vessel damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding medical device made of foreign material is used to treat vascular diseases, then the device can restore proper blood flow and support vessel structure, but it causes thrombosis formation and vessel occlusion
Solution Approach 1:
A fibrin coating is applied as an intermediary layer between the foreign material device and the blood. This coating acts as a mediator that prevents direct contact between thrombogenic device surfaces and blood components, thereby reducing thrombosis formation while maintaining the structural support function of the device
Solution Approach 2:
The device combines synthetic materials (nitinol or stainless steel for the mesh structure) with a biological material (fibrin coating) to create a composite structure. The synthetic component provides mechanical strength and self-expanding capability, while the biological component provides thromb resistance and promotes endothelialization
2Object-generated harmful factors
If anticoagulant medications are administered to prevent thrombosis, then thrombus formation is reduced, but bleeding risk increases and endothelialisation is impaired
Solution Approach 1:
The fibrin-coated device provides its own thromboprotection through the inherent properties of the fibrin coating, eliminating the need for systemic anticoagulant therapy. The coating naturally resists thrombosis without interfering with the patient's coagulation system, thus avoiding bleeding complications and allowing normal wound healing
Solution Approach 2:
The thromboprotection function is extracted from the systemic medication approach and integrated directly into the device itself through the fibrin coating. This localizes the protective effect to the device surface without requiring whole-body anticoagulation
3Ease of operation
If the medical device is made compact for easy insertion into vessels, then delivery is simplified, but the coating durability and endothelialisation promotion may be compromised
Solution Approach 1:
The fibrin coating is applied as a thin, flexible film on the device surface that can accommodate the compressed state during delivery and the expanded state during use. This thin-film approach maintains coating integrity through the delivery system while providing sufficient surface area for thromb resistance and endothelial attachment after deployment
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 effectively prevents thrombosis and promotes endothelialization, ensuring the foreign material is encapsulated by a neointima layer, reducing the risk of further complications and eliminating the need for continuous anticoagulant therapy.
Implementation Method 1
formed or constructed at least partially from nickel titanium alloy
Implementation Method 2
self-expandable mesh structure
Implementation Method 3
coated in an antithrombogenic and endothelialisation promoting coating, preferably fibrin
Implementation Method 4
promotes the endothelisation of the walls of the human vessels
Data Source
AI summary
The invention relates to a medical device for use in human vessels, in particular in the carotid artery, comprising: a self-expandable mesh structure which at least partially forms a curved wall, and has, in a radially compressed state, a cross-sectional diameter of not more than 2.5 mm, wherein the mesh structure is formed of at least one mesh structural element which has a height that is no more than 200 μm, in particular no more than 150 μm, preferably no more than 70 μm, where the height is measurable along a diameter of the mesh structure, and wherein the mesh structure is at least partially formed of a nickel titanium alloy and is at least partially coated in fibrin.