Hemostasis Valve Flow Control for Low-Blood-Loss Aspiration
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Solution Overview
Problem
Existing thrombectomy procedures face challenges in effectively capturing a broad spectrum of thrombus types and managing excessive blood loss during aspiration, often leading to premature termination due to high blood flow rates when the catheter tip loses contact with the thrombus.
Innovation Solution
A vacuum aspiration system with a flow regulator that toggles between low and high flow modes, featuring a transparent window for visual confirmation of clot capture, and optional secondary catheters for additional clot retrieval, along with a reinfusion circuit to minimize blood loss and facilitate thrombus removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high flow rate aspiration is used to remove thrombus, then productivity of thrombus removal is improved, but blood loss increases excessively
Solution Approach 1:
The system dynamically adjusts aspiration flow rate between low and high settings based on real-time conditions. The flow regulator allows the operator to switch between low flow rate (for maintaining contact with thrombus during engagement) and high flow rate (for rapid thrombus removal once engaged), optimizing both productivity and blood loss management throughout different phases of the procedure
Solution Approach 2:
The system changes the flow rate parameter from a fixed high value to a variable parameter that can be adjusted between low and high states. This parameter change allows the system to adapt to different procedural needs: low flow for stable engagement and high flow for efficient removal, thereby resolving the contradiction between productivity and blood loss
2Loss of substance
If low flow rate aspiration is used to minimize blood loss, then blood loss is reduced, but thrombus removal efficiency decreases
Solution Approach 1:
The system employs periodic alternation between low and high flow rate modes during the aspiration process. Low flow rate is used during engagement phases to minimize blood loss, while high flow rate is activated periodically during removal phases to maximize productivity. This periodic switching allows the system to achieve both blood loss reduction and efficient thrombus removal
3Adaptability or versatility
If large diameter catheter is used to improve thrombus capture capability, then ability to capture thrombus is improved, but blood loss increases due to higher flow rates
Solution Approach 1:
The large diameter catheter is paired with a dynamic flow regulation system that adjusts aspiration flow rate based on procedural needs. The catheter's large diameter provides superior thrombus capture capability, while the flow regulator compensates by reducing flow rate during engagement to minimize blood loss, and only increasing flow rate when thrombus is securely engaged for removal
4Loss of substance
If flow regulator is added to control aspiration flow, then blood loss is reduced through controlled flow rates, but device complexity increases
Solution Approach 1:
The flow control function is segmented as a separate, modular flow regulator component that can be integrated into the existing aspiration system. This segmentation allows the complex flow regulation mechanism to be designed and manufactured independently, then assembled with the catheter and pump components, reducing overall system complexity while achieving blood loss reduction through controlled flow rates
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 system reduces blood loss and enhances the ability to capture thrombi by allowing controlled flow rates and visual confirmation, thereby improving the efficiency and safety of thrombectomy procedures.
Implementation Method 1
A first vacuum aspiration system... A connector is configured to place a source of aspiration (vacuum) in communication with the flow path
Implementation Method 2
A flow regulator is configured to regulate fluid flow through the flow path
Data Source
AI summary
A hemostasis valve may be used with a catheter such as an aspiration catheter. The hemostasis valve comprises a support, and at least a first lever, pivotably carried with respect to the support. A collapsible tubular sidewall defining a valve lumen is carried by the support. A filament is formed into a loop around the tubular sidewall, the filament having at least a first tail portion extending away from the loop to the first lever. A first spring may be configured to move the first lever in a direction that pulls the first tail portion away from the tubular sidewall, reducing the diameter of the valve lumen in response to reducing the diameter of the loop. A second tail portion may extend away from the loop to a second lever. Each tail portion may be attached to its respective lever, or may be slidably advanceable around a fulcrum on the lever and attached with respect to the support.