Expandable Balloon Cardiac Pump for High Flow With Low Hemolysis
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Solution Overview
Problem
Current circulatory assist devices are inadequate for patients in cardiogenic shock or high-risk PCI, requiring high blood flows (3-5 L/min) with a compact delivery profile, minimal hemolysis, and reduced trauma to cardiovascular structures.
Innovation Solution
A heart assist device with an expandable cup and inflatable balloon mechanism, capable of producing high blood flows (3-10 L/min) while maintaining a low delivery profile (≤18 Fr) and minimizing hemolysis, featuring a volume displacement member that operates at frequencies up to 10,000 beats per minute.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If impeller pump systems are operated at higher speeds to produce higher flows, then blood flow increases, but hemolysis increases excessively
Solution Approach 1:
The patent replaces the traditional impeller-based mechanical pumping system with a balloon-based pneumatic pumping system. The balloon is cyclically inflated and deflated to displace blood, eliminating the high-speed rotating impeller that causes excessive shear stress and hemolysis. This substitution maintains adequate blood flow while significantly reducing mechanical trauma to blood cells.
2Productivity
If impeller pumps are made larger to produce higher flows, then blood flow increases, but device profile increases inhibiting percutaneous delivery
Solution Approach 1:
The patent employs a dynamic design where the pump chamber is collapsible between a compressed delivery configuration and an expanded operational configuration. During delivery, the chamber is compressed to a small profile suitable for percutaneous introduction. Once positioned, it expands to provide the necessary pumping capacity for high blood flow, thus resolving the contradiction between size and functionality.
Solution Approach 2:
The pump chamber is nested within a delivery catheter during introduction, allowing the device to pass through peripheral vessels in a compact form. After positioning, the chamber is deployed from the catheter to its functional configuration, enabling the device to achieve adequate pumping capacity without requiring a large delivery profile.
3Productivity
If a device is made larger to produce higher flows, then blood flow increases, but trauma to cardiovascular structures increases
Solution Approach 1:
The pump chamber dynamically transitions between compressed and expanded states. During delivery, the compressed state minimizes interaction with and trauma to cardiovascular structures. After positioning, the chamber expands to provide adequate pumping capacity, thus achieving high blood flow without excessive trauma during the critical delivery phase.
4Productivity
If IABP is used to increase blood flow, then afterload increases which is counter-productive
Solution Approach 1:
The patent replaces the IABP balloon inflation mechanism with a collapsible pump chamber that actively pumps blood forward. This substitution eliminates the counter-productive afterload increase associated with IABP, as the pump chamber directly propels blood through the circulatory system without increasing the resistance the heart must overcome.
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 provides efficient cardiac support with reduced hemolysis and trauma, enabling percutaneous introduction and endovascular placement, suitable for a wide range of patient conditions.
Implementation Method 1
a volume displacement member cyclically movable between a low-volume state and a high-volume state. In the high-volume state, the volume displacement member is configured to displace a volume of blood from the pumping chamber
Implementation Method 2
The expandable cup is collapsed to a low-profile configuration suitable for percutaneous delivery and expansion to an operational configuration with a pumping chamber in which the balloon is positioned
Data Source
Figure 1A~2
Figure 3A~3B
Figure 4
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.