Superior Vena Cava Occlusion Control for Ventricular Unloading
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Solution Overview
Problem
Current treatments for heart failure, including heart failure with reduced ejection fraction and pulmonary hypertension, lack effective device-based solutions that can reduce cardiac remodeling, ventricular overload, and associated complications without causing severe side effects, and existing pharmaceutical approaches are systemic and do not address localized cardiac structure issues.
Innovation Solution
A system and method for regulating venous blood return through the superior vena cava (SVC) using a catheter with a flow limiting element, controlled by a controller, to intermittently occlude the SVC over multiple cardiac cycles, reducing ventricular overload and cardiac preload, and improving cardiac output without increasing renal vein pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a flow limiting element is used to occlude the superior vena cava, then ventricular overload and cardiac preload are reduced, but device complexity increases
Solution Approach 1:
The device segments the venous return pathway by selectively occluding the superior vena cava while leaving the inferior vena cava patent. This is achieved through a flow limiting element positioned specifically in the SVC, allowing differential control of venous inflow to the right atrium and enabling targeted reduction of ventricular preload without complete venous occlusion
Solution Approach 2:
The flow limiting element provides dynamic control of venous flow through adjustable occlusion levels. The device can be configured to provide partial or complete occlusion and can be adjusted to vary the degree of flow limitation, allowing optimization of cardiac unloading effects while maintaining safety margins and avoiding fixed occlusion states
2Reliability
If intermittent occlusion is applied over multiple cardiac cycles, then cardiac remodeling is arrested or reversed, but treatment duration increases
Solution Approach 1:
The device implements periodic occlusion of the superior vena cava applied over multiple cardiac cycles. This sustained periodic action creates repeated periods of cardiac unloading that allow myocardial remodeling to occur, with each occlusion cycle providing therapeutic benefit while the intermittent nature prevents chronic complications of continuous occlusion
3Reliability
If SVC occlusion is used to reduce ventricular pressures, then cardiac output improves, but risk of venous congestion increases
Solution Approach 1:
The device applies local quality control by selectively occluding only the superior vena cava pathway while maintaining patency of the inferior vena cava. This localized approach redirects venous flow through alternative pathways, reducing pressure in the SVC and right heart without causing generalized venous congestion, as the IVC remains open to provide collateral venous return
Data Source
AI summary
Systems and methods are provided for treating conditions such as heart failure and/or pulmonary hypertension by at least partially occluding flow through the superior vena cava for an interval spanning multiple cardiac cycles. A catheter with an occlusion device is provided along with a controller that actuates a drive mechanism to provide at least partial occlusion of the patient's superior vena cava, which reduces cardiac filling pressures, and induces a favorable shift in the patient's Frank-Starling curve towards healthy heart functionality and improved cardiac performance. The system may include sensors to determine the degree of occlusion of the superior vena cava. The occlusion system may be used to reduce volume in a heart and facilitate a cardiac procedure. The occlusion system may be used to relieve an overloaded chamber during and/or after deploying a VAD.