Embolus Removal Device with Proximal Flow Restrictor
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Solution Overview
Problem
Current mechanical thrombectomy devices for ischemic stroke treatment are cumbersome, ineffective in capturing small emboli, prone to complications like hemorrhage, and limited in treating distal smaller vessels due to large device profiles and poor visibility, leading to incomplete clot removal and risk of new strokes.
Innovation Solution
A clot removal device with an expandable treatment member and a proximal flow restrictor that can be compactly delivered through a catheter, expands to engage clots, and uses aspiration to remove them, featuring a mesh or cage design with radiopaque markers for visibility and surface modifications for improved clot adhesion, allowing for precise clot capture and reduced risk of hemorrhage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If filter-type thrombectomy devices are used to capture emboli, then embolus removal capability is improved, but device complexity and difficulty of delivery increase
Solution Approach 1:
The device is divided into distinct functional segments: a delivery system for navigation, an expandable treatment member with flow restrictor for embolus capture, and a retrieval mechanism. This segmentation allows each component to be optimized independently, reducing overall complexity while maintaining effectiveness.
Solution Approach 2:
The expandable treatment member with flow restrictor is nested within the delivery system during insertion, allowing the device to pass through small catheters. Upon deployment, the treatment member expands to its full functional size, enabling effective embolus capture without requiring a large delivery profile.
2Volume of moving object
If stent-like mechanical thrombectomy devices are used, then device profile is reduced, but capability to capture small emboli deteriorates
Solution Approach 1:
The flow restrictor is deployed preliminarily to create a containment zone before the expandable treatment member is fully expanded. This preliminary action prevents small emboli from escaping distally during the expansion process, ensuring they are captured even when the device profile is minimized during delivery.
Solution Approach 2:
The device transitions dynamically from a compact delivery configuration to an expanded treatment configuration. The expandable treatment member can adjust its volume and surface area to match the size of the embolus being treated, allowing effective capture of small emboli while maintaining a small profile during delivery through small vessels.
3Duration of action of moving object
If existing mechanical thrombectomy devices are used, then treatment window is expanded beyond three hours, but risk of hemorrhage and complications increases
Solution Approach 1:
The flow restrictor converts the potentially harmful force of blood flow into a beneficial containment mechanism. By restricting flow proximal to the embolus, it creates a pressure gradient that helps push the embolus toward the treatment member while preventing distal migration, thereby reducing the risk of hemorrhage from vessel manipulation.
Solution Approach 2:
The device changes the flow parameters (velocity, pressure distribution) within the vessel by introducing the flow restrictor. This creates a controlled flow environment that reduces turbulent shear forces on the vessel wall and embolus, minimizing hemorrhage risk while enabling effective embolus removal even in the extended treatment window.
4Reliability
If existing thrombectomy devices are used, then embolus capture is achieved, but visibility and radiopacity are poor
Solution Approach 1:
The device incorporates radiopaque materials that appear distinct under fluoroscopic imaging, allowing real-time visualization of device position, expansion, and embolus capture. This enables the operator to confirm proper deployment and embolus engagement without compromising the capture mechanism.
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 captures and removes clots from blood vessels with reduced risk of hemorrhage and improved visibility, enabling safer and more complete clot retrieval in both large and small vessels, overcoming the limitations of existing devices.
Implementation Method 1
the covered distal section forms a seal with the distal end of the access catheter
Implementation Method 2
aspiration is applied through the access catheter and through the uncovered proximal section to remove the clot or embolus from the blood vessel
Data Source
AI summary
A clot removal device has an expandable treatment member having a distal tip and a proximal end, a delivery wire having a distal end coupled to the proximal end of the expandable treatment member, and a flow restrictor carried along the delivery wire at a location that is separate and proximal from the expandable treatment member. The flow restrictor has a body with a distal section and a proximal section, the distal section being covered and the proximal section being uncovered. The expandable treatment member is moveable relative to the flow restrictor, and can be retracted into the distal section.