Expandable Cardiac Assist Pump for High-Flow Percutaneous Support
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Solution Overview
Problem
Current circulatory assist devices are inadequate for patients in cardiogenic shock or high-risk PCI, as they either fail to provide sufficient blood flow, cause hemolysis, or require surgical placement due to large size, and often result in complications like bleeding and infection.
Innovation Solution
A heart assist device with a compact profile and expandable cup mechanism that produces high blood flows (3-10 L/min) via a volume displacement member, such as an inflatable balloon, operating at frequencies up to 10,000 beats per minute, minimizing hemolysis and trauma to cardiovascular structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If impeller pumps are made larger to produce higher flows, then blood flow rate is improved, but device profile becomes too large for percutaneous delivery and causes trauma to cardiovascular structures
Solution Approach 1:
The pump device employs a collapsible housing that can transition between an expanded operational state for high flow generation and a compressed delivery state for percutaneous insertion. This dynamic transformation allows the device to achieve both large size for productivity and small size for deliverability at different operational phases
Solution Approach 2:
The pump utilizes periodic expansion and compression of the housing to drive blood flow through the collapsible structure. This periodic action enables the device to maintain compact size during delivery while achieving high flow rates during operation through rhythmic expansion cycles
2Productivity
If impeller pumps operate at higher speeds to produce higher flows, then blood flow rate is improved, but hemolysis increases
Solution Approach 1:
The pump uses pneumatic actuation through an inflatable membrane to drive blood flow, replacing traditional high-speed mechanical impellers. This hydraulic/pneumatic mechanism achieves high flow rates through pressure-driven periodic expansion rather than high-speed rotation, significantly reducing shear stress and hemolysis
Solution Approach 2:
The invention replaces the traditional mechanical impeller system with a pneumatic-membrane system. The inflatable membrane expands and compresses the collapsible housing to drive flow, substituting high-speed mechanical rotation with lower-speed pneumatic actuation that generates sufficient flow without excessive shear forces
3Productivity
If current circulatory assist devices are used, then some blood flow support is provided, but flows are insufficient for patients in cardiogenic shock requiring at least 5 L/min
Solution Approach 1:
The pump device is segmented into multiple functional components including the collapsible housing, inflatable membrane, and flow channels that work together to achieve high flow rates. This segmentation allows each component to be optimized for its specific function while collectively delivering the required 5 L/min flow for cardiogenic shock patients
4Productivity
If ECMO systems are used, then blood flow support is provided, but morbidity increases due to multiple catheterizations, bleeding, thrombus, and infection
Solution Approach 1:
The pump device extracts and eliminates the need for multiple catheterization sites by providing a single self-contained pump unit that can be delivered percutaneously through one access point. This removes the harmful effects associated with multiple catheterizations, including bleeding, thrombus formation, and infection risks
5Ease of operation
If IABP is used, then afterload is reduced, but blood flow improvement is inadequate for significantly compromised hearts
Solution Approach 1:
The device dynamically adjusts blood flow through periodic expansion and compression of the collapsible housing, actively pumping blood rather than passively reducing afterload. This dynamic pumping mechanism provides sufficient flow improvement for significantly compromised hearts while maintaining afterload reduction benefits
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 achieves high blood flow rates with reduced hemolysis and minimal trauma, allowing percutaneous delivery and effective support for cardiogenic shock and high-risk PCI, while maintaining a small size for easy insertion and retrieval.
Implementation Method 1
A heart assist device with a compact profile and expandable cup mechanism that produces high blood flows (3-10 L/min) via a volume displacement member, such as an inflatable balloon, operating at frequencies up to 10,000 beats per minute
Data Source
AI summary
A cardiac assist device with an expandable cup (4) having a transport state and an operational state, the expandable cup comprising a plurality of inflow apertures (5), and an outflow nozzle (6), and an inflatable balloon (8) positioned inside the expandable cup (4). A catheter assembly (3) is connected to the inflatable balloon (8) during operation, and a control unit (2) is connected to the catheter assembly (3). The control unit (2) is arranged to operate the inflatable balloon (8) with a frequency of more than 100 beats per minute.


