Remodelable Venous Occlusion Device for Valve Insufficiency
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Solution Overview
Problem
Current treatments for venous valve insufficiency, such as varicose veins, are inadequate due to discomfort, invasive surgical methods, and potential side effects, necessitating improved techniques for effectively occluding venous vessels.
Innovation Solution
A medical product featuring a remodelable material with sclerosants that promotes tissue ingrowth within venous vessels, using angiogenic extracellular matrix materials like porcine small intestine submucosa to enhance occlusion and tissue integration, thereby addressing venous valve insufficiency and varicosities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If elastic stockings are used to apply external pressure to force leaflets into apposition, then valve function is improved, but patient comfort and appearance deteriorate
Solution Approach 1:
The invention extracts the function of forcing leaflets into apposition from the external elastic stocking and transfers it to an internal occlusion device. The occlusion device is placed within the vein to directly close the lumen and force leaflet apposition, eliminating the need for external compression stockings and thereby improving patient comfort while maintaining valve function.
Solution Approach 2:
The invention introduces an intermediary occlusion device that acts as a mediator between the vein wall and the blood flow. This device contains sclerosing agents that promote tissue ingrowth and permanent occlusion, serving as a temporary structure that facilitates permanent valve repair without requiring continuous external compression.
2Reliability
If surgical constriction methods are used to bring incompetent leaflets into closer proximity, then valve function is improved, but surgical risks and recovery time increase
Solution Approach 1:
The invention replaces the mechanical surgical constriction system with a chemical-biological system. Instead of physically constricting the vein through surgery, the occlusion device delivers sclerosing agents that chemically induce tissue ingrowth and permanent occlusion. This substitution eliminates surgical risks while achieving the same functional result of bringing leaflets into apposition.
Solution Approach 2:
The invention changes the parameter of intervention from mechanical (surgical constriction) to chemical-biological (sclerosing agents). The sclerosing agents alter the biological parameters of the vein wall by inducing inflammation and tissue ingrowth, leading to permanent occlusion without the need for mechanical surgical intervention.
3Reliability
If vein stripping and ligation are performed to remove the GSV, then venous reflux is eliminated, but patient recovery time and surgical invasiveness increase
Solution Approach 1:
The invention extracts the function of eliminating reflux from the invasive vein stripping procedure and achieves it through a minimally invasive occlusion device. The device is delivered through a catheter and remains within the vein to promote permanent occlusion, eliminating the need for surgical removal of the vein and significantly reducing recovery time.
Solution Approach 2:
The invention performs preliminary action by delivering the occlusion device and sclerosing agents before any surgical removal of the vein. The device is placed within the vein to promote tissue ingrowth and occlusion, and only after permanent occlusion is achieved would vein removal be considered, thereby eliminating the need for invasive surgery in many cases.
4Ease of operation
If sclerosing agents are used alone to injure the vein lining and promote occlusion, then minimally invasive treatment is achieved, but occlusion effectiveness may be insufficient
Solution Approach 1:
The invention merges the minimally invasive delivery method with enhanced occlusion effectiveness by combining sclerosing agents with an occlusion device. The device provides mechanical occlusion while simultaneously delivering sclerosing agents to promote tissue ingrowth, thereby achieving both minimally invasive treatment and reliable occlusion effectiveness.
Solution Approach 2:
The invention uses composite functionality by combining the occlusion device structure with sclerosing agents. The device itself acts as a scaffold that promotes tissue ingrowth, while the sclerosing agents provide chemical stimulation. This composite approach ensures both minimally invasive delivery and reliable permanent 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 solution effectively occludes venous vessels, reducing reflux and promoting tissue integration, which can lead to improved treatment outcomes for venous valve insufficiency and varicosities with reduced discomfort and invasive procedures.
Implementation Method 1
The remodelable material is configured for deployment within a venous vessel and is effective to promote the ingrowth of patient tissue into the lumen of the venous vessel
Implementation Method 2
The remodelable material includes one or more sclerosants that are effective to injure the lining of the venous vessel so as to enhance the ingrowth of patient tissue into the remodelable material
Implementation Method 3
using angiogenic extracellular matrix materials like porcine small intestine submucosa to enhance occlusion and tissue integration
Data Source
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AI summary
Described are methods, devices, and systems for occluding or ablating vascular vessels. Noninvasive procedures can be used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous valve insufficiency. Further described is the cooperative use of an angiogenic remodelable material with one or more sclerosing agents to cause closure of a targeted bodily vessel.