Interseptal Occlusion Device With Electrospun Tissue-Scaffolding Membrane
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Solution Overview
Problem
Current occlusive devices for septal defects, such as atrial septal defects and patent foramen ovale, cause chronic inflammation, disrupt cardiac conduction, limit septal compliance, and require long-term medical therapy, while obstructing future treatment options and increasing stroke risk.
Innovation Solution
The development of an interseptal occluding device using an electrospun microfiber or nanofiber membrane with a lightweight frame, promoting tissue growth and mimicking septal compliance, allowing for future septal access and reducing the need for long-term medical therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current occlusive devices are used to obstruct blood flow through septal defects, then the defect is closed, but chronic inflammation and stroke risk increase
Solution Approach 1:
The patent changes the material parameters from traditional PTFE/ePTFE to electrospun nanofiber membranes with specific pore sizes (50-500 nm) and composition ratios. This parameter change enables the device to maintain defect closure while promoting tissue integration and reducing chronic inflammation through biocompatible material properties.
Solution Approach 2:
The device employs composite material structures combining electrospun nanofibers with specific polymer compositions (polyurethane, polyethylene terephthalate, polyglycidyl methacrylate) and surface treatments. This composite approach creates a material that provides mechanical closure while actively reducing inflammation and stroke risk through controlled material degradation and tissue engagement.
2Strength
If stiff and dense braids are used in occlusive devices, then structural strength is improved, but conduction network disruption and arrhythmia risk increase
Solution Approach 1:
The patent replaces stiff braided structures with flexible electrospun nanofiber membranes that have controlled thickness and mechanical properties. These thin film structures provide sufficient strength for defect closure while being compliant enough to avoid disrupting the cardiac conduction network, thereby reducing arrhythmia risk.
Solution Approach 2:
The device changes the mechanical parameters by using electrospun nanofibers with controlled diameter (50-500 nm) and density, creating a material that achieves structural strength through distributed fiber architecture rather than dense braiding. This parameter change maintains strength while improving flexibility and biocompatibility.
3Duration of action of stationary object
If PTFE is used in occlusive devices, then device durability is improved, but acute thrombus formation and intimal hyperplasia increase
Solution Approach 1:
The patent changes the material composition parameters by replacing PTFE with electrospun nanofiber membranes made from polyurethane, polyethylene terephthalate, or polyglycidyl methacrylate. These material parameter changes maintain device durability through controlled mechanical strength while eliminating the thrombus formation and intimal hyperplasia risks associated with PTFE through improved surface properties and biocompatibility.
Solution Approach 2:
The device uses composite material strategies combining multiple polymer materials with complementary properties. The electrospun nanofiber structure provides mechanical durability while the specific polymer composition and nanoscale architecture create a surface that resists thrombus formation and promotes tissue integration, eliminating the harmful effects of traditional PTFE.
4Reliability
If protruding bulky mesh components are used, then occlusion is achieved, but chronic inflammation and slow healing response increase
Solution Approach 1:
The patent replaces bulky mesh components with thin film electrospun nanofiber membranes that provide effective occlusion through their continuous fiber structure. This thin film approach reduces the device profile, minimizing mechanical irritation to surrounding tissue and thereby reducing chronic inflammation while accelerating the healing response through reduced foreign body reaction.
Solution Approach 2:
The device changes the geometric parameters by transitioning from bulky three-dimensional mesh structures to thin two-dimensional nanofiber membranes with controlled thickness and pore distribution. This parameter change maintains occlusion effectiveness while significantly reducing the device volume that elicits chronic inflammatory responses and delays healing.
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 immediate septal occlusion, supports endothelial cell growth, reduces inflammatory response, and maintains septal compliance, minimizing stroke risk and enabling future therapeutic options without the need for prolonged medication.
Implementation Method 1
an electrospun microfiber or nanofiber membrane
Data Source
AI summary
According to some embodiments, an interseptal occluding device comprises a support structure comprising a first anchoring portion and an opposite second anchoring portion, a lumen extending through a center of the first anchoring portion and a center second anchoring portion, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature, and an expanded configuration, in which the first and second anchoring portions extend radially outwards from the lumen; and a membrane coupled to the first anchoring portion, the membrane configured to occlude a majority of the lumen when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane.