Helical Embolic Filter Structure for Large Emboli Capture
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Solution Overview
Problem
Existing embolic protection devices are inadequate in preventing large emboli from entering critical vessels, such as the brain or lungs, due to limitations in design and deployment mechanisms, leading to potential stroke or pulmonary embolism.
Innovation Solution
An embolic protection device (EPD) with a filament made of super-elastic alloy, configured to transition from an un-deployed state within a needle to a deployed state within a vessel, featuring a helical support portion and a funnel-shaped filter portion with reducing elements, anchored to the vessel wall, and deployable via an electromechanical system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing embolic protection devices are used, then they can be deployed in blood vessels, but they fail to effectively capture large emboli due to design limitations
Solution Approach 1:
The device is divided into distinct functional segments: a support portion with elongated coils for structural integrity and axial compression resistance, and a filter portion with tapered coils for emboli capture. This segmentation allows each portion to be optimized for its specific function, improving overall reliability without excessive complexity.
Solution Approach 2:
The device transitions from a linear un-deployed state suitable for delivery through catheters to a three-dimensional deployed state with radial expansion. This dimensional change enables the filter portion to create an effective capturing structure that can intercept large emboli while maintaining deliverability through standard access routes.
2Strength
If the device uses a simple structure, then it is easier to manufacture and deploy, but it cannot resist axial compression or secure large emboli
Solution Approach 1:
Different coil configurations are applied to different portions of the device: the support portion uses elongated coils with pitch greater than diameter specifically optimized for axial compression resistance, while the filter portion uses tapered coils optimized for emboli capture. This local differentiation of structural properties provides targeted strength where needed without unnecessary complexity elsewhere.
Solution Approach 2:
The device employs composite coil structures combining different geometric configurations (elongated coils and tapered coils) within a single continuous filament. This composite approach allows the device to exhibit multiple mechanical properties (axial rigidity, radial flexibility, emboli capture) from a unified structure, balancing strength requirements with manufacturing simplicity.
3Reliability
If the device is designed to capture large emboli, then stroke prevention is improved, but the device becomes more complex and difficult to deploy
Solution Approach 1:
The device is pre-configured in a compressed state within the delivery catheter, with the filament arranged to automatically expand into the filter configuration upon deployment. This preliminary arrangement ensures that the complex three-dimensional structure required for large emboli capture is already prepared, eliminating the need for complex deployment maneuvers and simplifying the operator's task.
Solution Approach 2:
The device transitions dynamically from a low-profile delivery state to an expanded filtering state. This dynamic transformation allows the device to navigate through the vascular system in a compact form and then automatically assume its functional configuration with large capture capacity once positioned, improving ease of operation while maintaining stroke prevention capability.
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 EPD effectively captures emboli larger than a predetermined size, resisting axial compression and ensuring secure deployment within the vessel, thereby reducing the risk of stroke or pulmonary embolism.
Implementation Method 1
a wire or a filament, which may be made of a super-elastic alloy (e.g., nitinol). The device, which has a proximal and a distal end, assumes two states--a constrained, un-deployed state (which may be linear, substantially linear, non-linear, or a combination), and an expanded, deployed state, in which the filament may be wound or coiled
Implementation Method 2
The support portion includes at least one elongated coil whose pitch, is greater than the coil diameter. Such an elongated coil is configured to resist axial compression of the support portion: as the elongated coil is compressed, its diameter grows, and support from the vessel walls, which opposes further compression, is therefore generated
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
Embodiments of the present disclosure are directed to systems, methods and devices for providing embolic protection in a patient, and implantation of devices (and systems thereof) for enabling such functionality. In some embodiments, a device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an un-deployed state and a deployed state. In the un-deployed state, the device or a portion thereof is configured to reside in the lumen of a thin needle or cannula having a diameter of less than about 0.5 mm (for example). The needle may include a curved portion. In the deployed state, the device has an axis which, when implanted, is positioned approximately parallel to the fluid flow of the vessel. In some embodiments, the device comprises a thin filament body whereby in a deployed state, at least a portion of the filament takes on a helical shape. In some embodiments, at least one helix coil has height or pitch greater than the coil diameter. In some embodiments, the device has a monofilament filter portion including at least one coil whose center is off the helix axis. The device may be made of a super-elastic alloy so that the device can transition between the un-deployed and the deployed states without plastic deformation (in at least some embodiments). In some embodiments, the device is configured for transcatheter delivery.