Expandable Catheter Pump for Heart Failure Flow
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Solution Overview
Problem
Current mechanical circulatory support devices for treating acute heart failure are either too large for minimally-invasive insertion or provide insufficient flow, and there is a need for a pump that can provide elevated flow rates with reduced risk of hemolysis and thrombosis.
Innovation Solution
A control system and method for controlling the priming of a catheter assembly, which includes a housing with one or more pumps and a controller, a catheter assembly with a proximal portion and an operative device at a distal portion, and an infusion system in fluid communication with the proximal portion of the catheter body, allowing for the secure engagement of the infusion system with the housing and the operation of the pump to direct fluid distally through the catheter assembly to remove gas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the flow rate of a rotary pump is increased by rotating the impeller faster, then the flow rate is improved, but the risk of hemolysis increases
Solution Approach 1:
The impeller speed is made dynamically adjustable rather than fixed, allowing the system to operate at optimal speeds that balance flow rate requirements with hemolysis risk reduction. The controller can modulate speed in real-time based on clinical needs and patient response.
Solution Approach 2:
The system changes the operational parameters of the pump by controlling impeller speed as a variable parameter rather than a fixed value. This allows optimization of the relationship between flow rate and hemolysis risk by adjusting speed within a range rather than operating at a single high speed.
2Productivity
If a fixed cross-section ventricular assist device is designed to provide near full heart flow rate, then the flow rate is improved, but the device size becomes too large for percutaneous insertion
Solution Approach 1:
The cannula is designed with expandable capability, transitioning from a compressed low-profile state for insertion to an expanded high-flow state during operation. This dynamic size change allows the device to achieve full heart flow rates while maintaining a small insertion profile.
Solution Approach 2:
The expandable cannula structure allows the large-diameter flow channel to be nested within a small-diameter delivery sheath during insertion. Once positioned, the cannula expands to provide the necessary flow capacity, effectively nesting the large functional structure within a small delivery structure.
3Loss of time
If the time to start therapy is reduced, then the treatment response time is improved, but the complexity of automated control increases
Solution Approach 1:
The system performs preliminary actions by automatically priming the catheter assembly and preparing fluid pathways before therapy is needed. The controller autonomously manages priming sequences, fluid delivery, and system readiness checks, reducing manual setup time and complexity.
Solution Approach 2:
The automated control system performs self-service functions by autonomously managing priming, fluid delivery, and operational parameters without requiring extensive manual intervention. The system monitors itself and adjusts operations automatically, reducing the burden on operators while maintaining rapid response 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 system enables faster and more effective setup, priming, and insertion of the catheter pump system, reducing the risk of user error and adverse events, while providing sufficient flow rates for various clinical indications.
Implementation Method 1
the pump to direct fluid distally through the catheter assembly to remove gas
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Various embodiments of a fluid handling system are disclosed herein. For example, the fluid handling system can include a catheter assembly and a console configured to control the operation of the catheter assembly. A removable interface member can be configured to provide fluid and electrical communication between the catheter assembly and the console. Additionally, a control system is disclosed for controlling operation of the fluid handling system.