Autoretroperfusion Catheter with Flow Regulator for Diffuse CAD
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Solution Overview
Problem
Conventional revascularization techniques, such as PTCA and CABG, are ineffective for patients with diffuse CAD, refractory angina, and diabetic patients with advanced coronary atherosclerosis, leading to high mortality and morbidity rates, and there is a need for alternative methods to treat 'no-option' patients who cannot undergo these procedures.
Innovation Solution
A perfusion system comprising a catheter with a coupler and flow regulator that allows for selective autoretroperfusion, enabling the delivery of oxygenated blood from an arterial source to the venous system, reducing pressure and promoting arterialization of venous vessels to improve blood flow and reduce stress on the vessels, thereby providing a continuous supply of oxygen-rich blood to ischemic areas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional revascularization techniques (PTCA, CABG) are used, then effective treatment is achieved for focal CAD, but treatment is ineffective for diffuse CAD and refractory angina
Solution Approach 1:
The catheter system divides blood flow delivery into multiple segments: arterial blood is drawn from the aorta, processed through a flow regulator, and delivered through multiple catheter lumens to different vascular beds simultaneously, enabling targeted treatment of diffuse disease throughout the coronary circulation
Solution Approach 2:
The perfusion system serves multiple functions: it provides retroperfusion to ischemic myocardium, regulates blood flow rates, controls pressure, and can be adapted for both acute and chronic applications, making it versatile for various CAD presentations including diffuse disease
2Productivity
If arterial blood is delivered to venous system with high pressure, then blood flow to ischemic areas is improved, but risk of venous rupture increases
Solution Approach 1:
The flow regulator device dynamically adjusts blood flow rates and pressure in real-time based on patient needs and venous system tolerance, allowing the system to optimize perfusion while preventing venous rupture through continuous adaptation of delivery parameters
Solution Approach 2:
The system incorporates pressure regulation mechanisms that prevent excessive pressure buildup before it can cause venous rupture, and includes monitoring capabilities to detect early signs of venous stress, providing protective measures in advance of potential damage
3Reliability
If venous vessels are used for retroperfusion, then arterialization of venous vessels is needed, but this requires time and gradual pressure increase
Solution Approach 1:
The system performs preliminary gradual pressure increases and flow adjustments before full retroperfusion is established, allowing venous vessels to adapt progressively to arterial conditions, reducing the risk of rupture while achieving complete arterialization over time
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 system effectively reduces the risk of venous rupture, achieves long-term autoretroperfusion, and provides a viable treatment option for 'no-option' patients by improving blood flow and reducing ischemic damage, potentially reducing mortality and morbidity in patients with diffuse CAD and refractory angina.
Implementation Method 1
a first flow regulator in communication with one or more of the coupler and the first tube, the first flow regulator operable to control a pressure and/or a flow of the blood through at least part of the system
Data Source
AI summary
Devices, systems, and methods for autoretroperfusion. In at least one embodiment of a perfusion system of the present disclosure, the system comprises a first catheter having a proximal end, a distal end, and a first lumen therethrough, the distal end configured for insertion into a luminal organ of a patient, a coupler defining an outlet port and a first port, the coupler configured to engage the proximal end of the first catheter at the outlet port and to receive blood from a blood supply through the first port, a first tube having a proximal end, a distal end, and a lumen therethrough, the distal end of the first tube configured to engage the first port of the coupler and to receive the blood from the blood supply, and a first flow regulator in communication with one or more of the coupler and the first tube, the first flow regulator operable to regulate a flow and/or a pressure of the blood through at least part of the system, wherein the system is configured to permit the blood from the blood supply to flow through the first tube, the coupler, and the first catheter into the patient to treat a patient condition.