Expandable Ventricular Support Pump for Small-Bore PCI Access
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Solution Overview
Problem
Existing mechanical circulatory support devices, such as the Impella 2.5 and Impella CP, require large bore access sites which increase the risk of bleeding, vascular dissection, or ischemia during high-risk percutaneous coronary intervention procedures, and are associated with clinically significant arrhythmia adverse events.
Innovation Solution
The Impella ECP™ blood pump is designed with a radially compressible structure allowing insertion through smaller access sites (e.g., 9 Fr) and is associated with a clinically significant arrhythmia adverse event rate of approximately 2.3% and a MACCE rate of 6.3% during high-risk PCI procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If large bore access sites are used for mechanical circulatory support devices, then device delivery is facilitated, but risk of bleeding, vascular dissection, or ischemia increases
Solution Approach 1:
The mechanical circulatory support device employs a dynamic structure that transitions from a compressed delivery configuration to an expanded operational configuration. The device is compressed to a small profile for percutaneous delivery through small-bore access sites, then expanded at the target location to provide full hemodynamic support functionality, thereby avoiding the need for large bore access while maintaining device performance
Solution Approach 2:
The device utilizes a nested structure where the pump assembly is contained within a delivery catheter in a compressed state. The pump housing and impeller are nested within the catheter lumen, allowing the entire device to be delivered through a small-bore catheter and then deployed by expanding the pump housing outward, similar to nested dolls being extracted and expanded sequentially
2Reliability
If mechanical circulatory support devices are used during high-risk PCI procedures, then ventricular support is provided, but clinically significant arrhythmia adverse events occur
Solution Approach 1:
The device incorporates a flexible, compliant housing that can adapt to the contours of the left ventricle and aorta. This flexibility allows the device to conform to cardiac motion and vascular anatomy, reducing mechanical irritation to the myocardium and vascular endothelium, thereby minimizing the generation of arrhythmias while maintaining effective blood flow support
Solution Approach 2:
The device replaces traditional mechanical ventricular assist systems with a more refined pump design that uses a small-bore, low-profile impeller and optimized flow dynamics. This substitution reduces the mechanical footprint and shear forces on cardiac tissue, decreasing the likelihood of mechanically-induced arrhythmias while preserving hemodynamic support efficacy
Data Source
AI summary
A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure includes inserting a mechanical circulatory support device into the vasculature of a human patient. The mechanical circulatory support device being movable between a compressed state and an expanded state. The mechanical circulatory support device is delivered into a heart of the human patient with the aid of a delivery assist device. Operating. The mechanical circulatory support device is operated for a support period. A clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.