Percutaneous Ventricular Assist Device with Pulsatile Flow Control
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Solution Overview
Problem
Current ventricular assist devices are not well-suited for right ventricular failure, restrictive cardiomyopathy, and often cause thrombus formation, non-physiologic flow, and complications such as gastrointestinal bleeding due to non-pulsatile flow and clotting factor depletion, with limited adaptability for acute myocardial infarction scenarios.
Innovation Solution
A ventricular assist device featuring a stent and rotor with magnets for percutaneous placement, a collar with a stator and power source for controlled rotation, and a timing control module to maintain pulsatile flow, which can be placed minimally invasively in supravalvular positions to support either ventricle, prevent thrombus formation, and adapt to native cardiac rhythms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If existing ventricular assist devices are used, then left ventricular support is provided, but adaptability for right ventricular failure and restrictive cardiomyopathy is poor
Solution Approach 1:
The device is designed with a percutaneous stent and rotor system that can be placed in either the aorta or pulmonary artery, enabling it to function as a left ventricular assist device, right ventricular assist device, or bi-ventricular assist device depending on placement location, providing universal support for various heart failure conditions
2Productivity
If existing devices are used, then mechanical support is provided, but non-physiologic non-pulsatile flow is generated causing gastrointestinal bleeding and clotting factor depletion
Solution Approach 1:
The rotor is driven by a timed electrical signal from a pacemaker-like timing control module that synchronizes rotation with the patient's native cardiac rhythm, creating pulsatile blood flow that mimics physiological conditions and reduces harmful effects such as gastrointestinal bleeding and clotting factor depletion
3Reliability
If existing devices are used, then ventricular support is provided, but thrombus formation risk is high
Solution Approach 1:
The synchronized pulsatile flow generated by timing the rotor rotation to the cardiac rhythm prevents blood stasis and reduces thrombus formation risk while maintaining effective ventricular support function
4Reliability
If existing devices are used, then left ventricular assistance is provided, but ease of use in acute myocardial infarction is limited due to apical placement requirements
Solution Approach 1:
The device separates the support function from the ventricle by placing the rotor-stent system in the aorta or pulmonary artery rather than requiring apical placement in the ventricle, allowing use in acute myocardial infarction where the ventricular tissue is friable
Solution Approach 2:
The aorta or pulmonary artery serves as an intermediary location that allows the device to support ventricular function without direct contact with the infarcted myocardial tissue, enabling use in acute myocardial infarction scenarios
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 maintains pulsatile physiologic flow, reduces thrombus risk, and supports both ventricles effectively, especially in acute myocardial infarction and cardiogenic shock, while minimizing disruption to the heart's anatomy and function.
Implementation Method 1
the stator and the rotor are arranged to interact in response to the application of power from the power source to the stator to cause the rotor to rotate about the longitudinal axis
Implementation Method 2
the collar includes a magnet set and the rotor includes a second plurality of magnets, the magnet set of the collar and the second plurality of magnets of the rotor cooperating to control a longitudinal position of the rotor with respect to the flow path
Data Source
AI summary
A ventricular assist device includes a stent for placement within a cardiac artery and arranged for placement, the stent arranged to have an open configuration defining a flow path, a rotor sized to fit within the stent and arranged for percutaneous placement the flow path, the rotor including a surface disposed about a central portion and angled with respect to the flow path and having a first plurality of magnets. A collar is sized for placement about the cardiac artery and includes a stator. A power source is coupled to the stator, and the stator and the rotor are arranged to rotate the rotor about an axis. A timing control module controls a rotational speed of the rotor. Accordingly, the surface of the rotor is arranged to move blood along the flow path in response to rotation of the rotor.