Aortic Occlusion and Perfusion Catheter with Flow Control Sheath
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Solution Overview
Problem
Current methods for cardiac procedures, such as coronary artery bypass grafting and heart valve repair, often require open-chest access, leading to significant trauma, long recovery times, and increased mortality and morbidity, especially for reoperations, and existing occlusion devices require separate lumens for perfusion and occlusion, which is inefficient.
Innovation Solution
An aortic occlusion and perfusion device with an expandable member that secures within the aorta and a catheter with openings for blood flow, allowing for controlled occlusion and perfusion without open-chest access, using a flow control sheath to manage pressure and blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If open-chest access (median sternotomy or lateral thoracotomy) is used for cardiac procedures, then accessibility to the heart and aorta is improved, but patient trauma, recovery time, and mortality risk increase significantly
Solution Approach 1:
The patent introduces a catheter-based occlusion device as an intermediary tool that enables aortic occlusion and cardiac procedures without requiring direct surgical exposure. The device mediates between the need for aortic control and the desire to avoid open-chest surgery, using percutaneous access through femoral arteries instead of sternotomy or thoracotomy
Solution Approach 2:
The invention replaces the mechanical system of external cross-clamps and open surgical access with a catheter-based endovascular system. The expandable occlusion member deployed within the aorta substitutes for external clamps, and the entire procedure is performed through catheter manipulation rather than direct mechanical exposure of the heart and great vessels
2Ease of operation
If external cross-clamp is applied to the aorta, then aortic occlusion is achieved, but emboli may be released into carotid or subclavian arteries causing strokes
Solution Approach 1:
The catheter-based occlusion device serves as an intermediary between the aorta and the surgical field, providing aortic occlusion without direct manipulation of the aortic wall. This intermediate approach prevents disruption of atherosclerotic plaques and emboli formation that occurs with external clamp application to calcified or atheromatous aortas
Solution Approach 2:
The device uses hydraulic principles by deploying an expandable balloon occlusion member inflated with fluid through the catheter lumen. This pneumatic/hydraulic occlusion method provides smooth, controlled aortic blockade without the mechanical stress and emboli release associated with rigid external cross-clamps
3Adaptability or versatility
If separate lumens or catheters are used for perfusion blood and occlusion fluids, then functional separation is achieved, but device complexity increases
Solution Approach 1:
The catheter is designed with multi-functionality, serving both as the delivery vehicle for the occlusion device and as the perfusion conduit. The single catheter structure integrates multiple functions (occlusion balloon delivery, perfusion blood flow, and positioning) that would traditionally require separate components, thereby reducing overall device complexity while maintaining functional separation where needed
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
Enables minimally invasive cardiac procedures by effectively occluding the aorta and perfusing blood flow, reducing trauma and recovery time, and minimizing the risk of emboli formation, while allowing for cardioplegic arrest without external cross-clamps or direct aortic punctures.
Implementation Method 1
an expandable member configured to expand within the aorta to secure the device within the aorta
Implementation Method 2
axial movement of the flow control sheath relative to the catheter selectively occludes or uncovers one or more of the openings located proximal to the expandable member
Data Source
AI summary
An aortic occlusion and perfusion device includes an expandable member configured to expand within the aorta. A catheter extends proximally from the expandable member in fluid communication with the expandable member. The catheter defines openings through which blood can pass with one or more of the openings located proximal to the expandable member and one or more of the openings located within the expandable member. The catheter defines a lumen in fluid communication with the one or more openings located within the expandable member, the lumen terminating at a terminus such that the lumen is not in fluid communication with a distal end portion of the catheter. A flow control sheath is disposed around the catheter proximal to the expandable member such that axial movement of the flow control sheath relative to the catheter selectively occludes or uncovers the one or more openings located proximal to the expandable member.