Laser-Cut Hypotube Torque Coupler for Tortuous Vessel Navigation
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Solution Overview
Problem
Current embolic protection devices face challenges in accessing and navigating through the highly tortuous and narrow cerebral vessels, particularly in procedures involving embolic protection and clot removal, where existing devices struggle with flexibility and pushability, leading to difficulties in effectively deploying filters and capturing emboli in a timely manner.
Innovation Solution
The development of a fiber-based embolic protection device with a corewire, hypotube, and a fiber bundle, featuring a laser-cut hypotube for increased flexibility, a torque coupler for controlled movement, and a distal tip for precise placement, allowing the device to transition from a low-profile delivery configuration to a deployed filtering configuration within the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the device uses a traditional rigid structure to maintain pushability, then it can maintain structural stability, but it cannot navigate through tortuous cerebral vessels
Solution Approach 1:
The device is divided into multiple segments including a corewire, a hypotube with laser-cut sections, and a fiber bundle. The laser-cut sections create discrete flexible zones that allow the device to bend and navigate tortuous vessels while the uncut sections maintain structural stability and pushability. This segmentation enables the device to adapt to vessel curvature without compromising overall structural integrity.
Solution Approach 2:
Different sections of the hypotube have different properties: laser-cut sections provide flexibility for navigating tortuous vessels, while uncut sections provide rigidity for maintaining pushability. The corewire has a non-circular cross-section in its distal portion to engage with the laser-cut hypotube and prevent rotation, while having a circular cross-section in its proximal portion for smooth delivery. This local differentiation of properties resolves the contradiction between flexibility and stability.
2Ease of operation
If the device uses a flexible structure to navigate tortuous vessels, then it can access narrow cerebral vessels, but it loses pushability and cannot be effectively delivered
Solution Approach 1:
The hypotube is segmented with laser-cut sections that provide flexibility for accessing narrow vessels, while uncut sections maintain the structural integrity needed for pushability. This allows the device to be effectively delivered through the vasculature while still being able to navigate tortuous paths and access narrow cerebral vessels.
Solution Approach 2:
The device combines different materials and structures: a metal corewire with a polymer coating, a hypotube with laser-cut sections, and a fiber bundle filter. This composite construction allows the device to exhibit both flexibility (from the laser-cut sections and fiber bundle) and pushability (from the corewire and uncut hypotube sections) simultaneously.
3Strength
If the device uses a large-diameter structure to maintain strength, then it can resist deformation, but it cannot access narrow cerebral vessels
Solution Approach 1:
The device uses a thin-walled hypotube with laser-cut sections that provides sufficient strength to resist deformation while maintaining a small overall diameter. The laser-cut sections allow the tube to flex and conform to narrow vessel diameters without requiring a large overall device size, enabling access to narrow cerebral vessels while maintaining structural strength.
Solution Approach 2:
The segmented structure with laser-cut sections allows the device to maintain strength through the uncut sections while the cut sections allow the device to conform to narrow vessel diameters. This segmentation enables the device to access narrow cerebral vessels without requiring a large overall diameter.
4Measurement precision
If the device uses a complex structure to provide controlled movement and torque coupling, then it can maintain precise positioning, but it increases device complexity
Solution Approach 1:
The torque coupler merges the corewire and hypotube into a unified structure that prevents relative rotation between them. This merging provides precise control and positioning without requiring separate complex control mechanisms. The friction-reducing coating on the corewire further simplifies the structure by eliminating the need for additional lubrication systems or complex interfaces.
Data Source
AI summary
An embolic protection device with a flexible fiber-based filter element is described associated with an integrated guide structure. The integrated guide structure comprises a corewire within a hypotube having an uncut proximal section and a distal section having laser cuts through the hypotube wall. A corewire extends through the hypotube with a low friction channel, which can have a friction reducing coil between the corewire and at least a portion of the hypotube. A torque coupler restricts rotation of the corewire while allowing at least some sliding of the corewire within the hypotube that provides for actuating the filter element and for curving the laser cut hypotube. Torque coupler designs provide connection to the laser cut hypotube. The fiber bundle has an initial undeployed configuration with the fibers aligned and a deployed configuration with the fibers bent.