Superior Vena Cava Occlusion Catheter for Ventricular Pressure Relief
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Solution Overview
Problem
Current device-based treatments for heart failure do not effectively reduce left and right ventricular end diastolic volumes and pressures without causing severe side effects, and pharmaceutical approaches fail to address localized cardiac remodeling, leading to progressive heart failure and increased morbidity.
Innovation Solution
A system and method for regulating venous blood return through the superior vena cava using a catheter with a flow limiting element, controlled by a controller to intermittently occlude the SVC, reducing ventricular overload and cardiac preload without increasing renal vein pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If device-based treatments occlude the vena cava to reduce ventricular volumes and pressures, then cardiac preload is reduced, but severe side effects occur including increased renal vein pressure
Solution Approach 1:
The invention divides the vena cava occlusion into two separate interventions: superior vena cava (SVC) occlusion and inferior vena cava (IVC) occlusion. The SVC occlusion device reduces right ventricular preload and pulmonary artery pressure without significantly affecting renal vein pressure, while the IVC occlusion device is positioned below the renal veins to selectively reduce systemic venous return while preserving renal venous flow. This segmentation allows independent control of different venous pathways to achieve therapeutic goals without harmful side effects.
Solution Approach 2:
The invention applies different occlusion strategies to different anatomical locations: SVC occlusion targets the upper venous return pathway to reduce pulmonary circulation pressure, while IVC occlusion targets the lower venous return pathway below the renal veins to reduce systemic venous return while preserving renal perfusion. Each location receives a tailored intervention based on its specific physiological role, achieving localized therapeutic effects without compromising other systems.
2Reliability
If pharmaceutical approaches are used to treat heart failure, then symptoms are palliated, but localized cardiac remodeling is not addressed and disease progression continues
Solution Approach 1:
The invention introduces mechanical intermediaries (occlusion devices) that physically intervene in the hemodynamic pathways to reduce ventricular volumes and pressures. These devices act as mechanical mediators that directly alter the physical conditions (preload, pressure) affecting cardiac remodeling, complementing pharmaceutical approaches that address symptoms through biochemical pathways. The mechanical intervention targets the structural changes directly by modifying the hemodynamic burden on the heart.
3Stress or pressure
If the inferior vena cava is occluded to reduce left ventricular volumes, then cardiac preload is reduced, but renal function may be compromised
Solution Approach 1:
The invention segments the vena cava occlusion into superior and inferior components with distinct anatomical positioning and functional goals. The IVC occlusion device is specifically positioned below the renal vein confluence to create a mechanical barrier that intercepts systemic venous return while allowing renal venous blood to drain freely into the inferior vena cava above the occlusion site. This spatial segmentation enables selective reduction of LV preload without compromising renal function.
4Stress or pressure
If the superior vena cava is occluded to reduce right ventricular volumes, then pulmonary artery pressure is reduced, but cerebral blood flow may be affected
Solution Approach 1:
The invention employs periodic or intermittent occlusion of the SVC rather than continuous occlusion. The occlusion device can be cycled between occluding and non-occluding states, or applied intermittently to reduce pulmonary artery pressure while allowing periodic restoration of normal venous flow to the right atrium and subsequent forward flow to the lungs and body. This periodic action prevents sustained interruption of cerebral venous drainage while achieving therapeutic reduction in pulmonary pressures.
Data Source
AI summary
Systems and methods and devices 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 occlusion device may include a lumen obstructed by a relief valve that may permit fluid flow through the occlusion device to release an excessive build-up of pressure.