Intraatrial Ventricular Assist Device via Percutaneous Delivery
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Solution Overview
Problem
Current ventricular assist devices (VADs) for heart failure are invasive and require cardiopulmonary bypass, limiting their acceptance and use in early-stage heart failure patients, where a less invasive method to augment heart function is needed to prevent progression of cardiac derangements.
Innovation Solution
A minimally invasive ventricular assist device is implanted within the heart's atrium, using a continuous flow pump with an outflow conduit passing through the atrial septum and subclavian vein to the subclavian artery, eliminating the need for a pump pocket and cardiopulmonary bypass, and featuring a flexible conduit and pressure-sensitive impellers for efficient blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current ventricular assist devices are used, then heart function can be augmented, but the procedure is highly invasive requiring cardiopulmonary bypass and pump pocket creation
Solution Approach 1:
The patent replaces the traditional mechanical VAD system requiring surgical implantation with a percutaneous delivery system that uses catheter-based techniques. The pump is delivered through a large-bore catheter inserted via femoral vein, eliminating the need for sternotomy, cardiopulmonary bypass, and pump pocket creation while maintaining the mechanical pumping function.
Solution Approach 2:
The patent introduces a large-bore catheter as an intermediary device to deliver the VAD pump and outflow graft to the heart. This catheter serves as a conduit that allows the pump to be positioned in the left ventricle and the outflow graft to be deployed into the aorta without direct surgical access to these chambers.
2Productivity
If traditional VAD implantation is performed, then cardiac output can be maintained, but morbidity and mortality increase due to invasive procedure
Solution Approach 1:
The patent substitutes the highly invasive surgical implantation mechanism with a percutaneous catheter-based delivery system. This replacement maintains the ability to sustain cardiac output while dramatically reducing procedural morbidity and mortality by avoiding sternotomy, cardiopulmonary bypass, and extensive surgical dissection.
3Reliability
If VAD is implanted in early-stage heart failure, then progression of cardiac derangements can be prevented, but current invasive methods limit acceptance
Solution Approach 1:
The patent replaces the invasive surgical implantation system with a percutaneous delivery system that is much more readily accepted by patients. The procedure can be performed through femoral vein access without sternotomy or cardiopulmonary bypass, making it suitable for early-stage heart failure patients who would otherwise be ineligible due to the high risks of traditional implantation.
4Object-affected harmful factors
If outflow conduit is routed through subclavian vein and artery, then less invasive implantation is achieved, but conduit length and complexity increase
Solution Approach 1:
The patent segments the outflow conduit into two distinct parts: an intracardiac portion positioned within the heart and a extracardiac portion routed through the subclavian vein and artery. This segmentation allows the conduit to be delivered percutaneously while maintaining a relatively simple routing path outside the heart, reducing overall device complexity compared to alternative long-distance extracardiac routes.
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
This approach reduces morbidity and mortality, minimizes thrombus formation, and allows for earlier intervention in heart failure, maintaining cardiac output while reducing left ventricular wall tension, and is suitable for smaller patients and those previously ineligible for pulsatile LVADs.
Implementation Method 1
a continuous flow pump with an outflow conduit passing through the atrial septum and subclavian vein to the subclavian artery
Implementation Method 2
featuring a flexible conduit and pressure-sensitive impellers for efficient blood flow
Data Source
AI summary
A medical devices and methods related thereto are disclosed. In an embodiment, the medical device including a pump configured to be inserted within an atrium of a heart, said pump comprising an inlet and an outlet. In addition, the pump includes a flexible outflow conduit coupled to the outlet and configured to carry blood. The outflow conduit includes a radially inner surface defining a throughbore, and a radially outer surface. Further, the pump comprises a driveline configured to conduct control and power signals between the pump and an external device. The driveline extends through the outflow conduit between the radially inner surface and the radially outer surface.