Thrombectomy Device with Flow Modulation Balloon
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Solution Overview
Problem
Current thrombectomy devices and systems fail to adequately control blood flow restoration in the cerebral vasculature, leading to reperfusion injury and limited clot retrieval, especially in the narrow and tortuous arteries of the brain, and lack simultaneous clot capture and flow modulation capabilities.
Innovation Solution
The development of a system that includes a catheter with a pushwire and a flow modulation member, such as an inflatable balloon, which applies pressure to enhance blood flow, captures clots using a self-expanding scaffold, and modulates blood flow to minimize reperfusion injury by selectively occluding and re-opening the vessel, allowing for simultaneous clot removal and postconditioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If mechanical thrombectomy is used to physically remove clots, then clot retrieval is achieved, but reperfusion injury occurs due to abrupt restoration of blood flow
Solution Approach 1:
The system performs preliminary actions by first engaging and partially removing the clot to restore some blood flow, then applying postconditioning therapy to protect tissues before completing clot removal. This staged approach prevents abrupt reperfusion injury while still achieving effective clot retrieval.
Solution Approach 2:
The system implements periodic action through postconditioning therapy, which involves cyclic modulation of blood flow or application of protective agents at specific time intervals after initial clot removal. This periodic intervention reduces reperfusion injury by controlling the timing and magnitude of blood flow restoration.
2Object-generated harmful factors
If tPA is used to dissolve clots, then clot dissolution is achieved, but treatment effectiveness is limited by narrow time window and adverse bleeding effects
Solution Approach 1:
The system extracts the harmful effects of tPA by replacing chemical clot dissolution with mechanical clot removal. The thrombectomy device physically engages and removes the clot through mechanical means, eliminating the need for tPA and its associated risks of bleeding and narrow treatment window.
Solution Approach 2:
The system applies mechanics substitution by replacing the chemical mechanism of tPA with a mechanical thrombectomy system. The device uses mechanical forces to engage, capture, and remove the clot, substituting chemical dissolution with physical removal to achieve clot clearance without bleeding complications.
3Length of moving object
If existing thrombectomy devices are used in narrow cerebral arteries, then clot engagement is attempted, but device control and clot retrieval are inadequate
Solution Approach 1:
The system applies local quality by designing the thrombectomy device with varying characteristics along its length - the distal end features a compliant, expandable capture structure adapted for narrow cerebral arteries, while the proximal end maintains structural integrity for operator control. This localized differentiation enables both navigation through narrow vessels and effective clot retrieval.
Solution Approach 2:
The system implements dynamics through the expandable clot capture member that can transition from a compressed delivery state to an expanded capture state. This dynamic transformation allows the device to navigate narrow arteries in a compact form, then expand at the target site to effectively engage and retrieve the clot with improved control.
4Productivity
If blood flow is abruptly restored after clot removal, then ischemia is relieved, but reperfusion injury increases infarction size
Solution Approach 1:
The system performs preliminary action by restoring blood flow partially through clot removal, then applying postconditioning therapy before completing the procedure. This staged reperfusion approach relieves ischemia while protecting tissues from the harmful effects of abrupt full reperfusion.
Solution Approach 2:
The system converts the potentially harmful abrupt reperfusion into a beneficial controlled reperfusion process. By using postconditioning therapy to modulate the reperfusion process, the system transforms what would be damaging abrupt flow restoration into a protected, controlled recovery that reduces infarction size while still relieving ischemia.
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
This system effectively reduces reperfusion injury, improves clot retrieval rates, and enables simultaneous clot capture and flow modulation, enhancing treatment outcomes for ischemic stroke by systematically restoring and regulating blood flow in the cerebral vasculature.
Implementation Method 1
applying pressure to an internal wall of the cerebral blood vessel to enhance blood flow in the vessel
Implementation Method 2
captures clots using a self-expanding scaffold
Data Source
AI summary
New devices, systems, and methods are disclosed for preventing, treating, and/or at least minimizing ischemia and/or reperfusion injury by restoring and/or modulating blood flow, particularly in the cerebral vasculature where blood vessels are narrow and tortuous. These devices, systems, and methods make it possible for a clinician to adequately and systematically restore blood flow to ischemic tissue while simultaneously modulating the blood flow to minimize reperfusion injury. New thrombectomy devices and systems, which, for example, expand with greater radial force, further enable improved binding with clots and restoration of blood flow.