SVC Occlusion Device for Heart Failure Ventricular Preload Management
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Solution Overview
Problem
Current treatments for heart failure, including pharmaceutical and device-based solutions, are ineffective in arresting or reversing cardiac remodeling and often exacerbate co-morbidities, with existing devices posing risks such as venous congestion and reduced systemic blood pressure.
Innovation Solution
Regulating venous blood return through the superior vena cava (SVC) using a catheter with a flow limiting element and a controller that intermittently occludes the SVC, allowing for ambulatory use and reducing ventricular overload without significant impact on left ventricular systolic pressure, thereby improving cardiac output and reducing venous congestion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If existing devices occlude the inferior vena cava to reduce ventricular preload, then ventricular overload is reduced, but venous congestion and reduced systemic blood pressure occur
Solution Approach 1:
The invention segments the venous return pathway by selectively occluding only the superior vena cava while leaving the inferior vena cava patent. This segmentation allows reduction of ventricular preload through SVC occlusion without causing the venous congestion that occurs with complete or IVC occlusion, as blood can still return through the IVC
Solution Approach 2:
The invention applies local quality by targeting a specific portion (SVC) of the venous return system rather than the entire IVC. The occlusion is localized to the SVC, which reduces preload effectively while preserving IVC flow to prevent venous congestion and maintain systemic blood pressure
2Object-affected harmful factors
If pharmaceutical approaches are used to reduce heart failure symptoms, then symptoms are palliated, but cardiac remodeling is not arrested or reversed
Solution Approach 1:
The invention employs periodic action through intermittent occlusion of the SVC. The occlusion is applied in cycles rather than continuously, allowing the heart to experience reduced preload periodically which promotes reverse remodeling over time while maintaining adequate perfusion during non-occluded phases
Solution Approach 2:
The invention changes the parameter of venous return by mechanically reducing it through SVC occlusion. This physical parameter change (venous return volume) directly addresses the underlying hemodynamic abnormality causing remodeling, unlike pharmaceuticals that only manage symptoms
3Stress or pressure
If continuous SVC occlusion is applied to reduce ventricular overload, then preload reduction is maximized, but systemic blood pressure and cardiac output are compromised
Solution Approach 1:
The invention uses periodic intermittent occlusion rather than continuous occlusion. The occlusion is applied for specific durations and then released, allowing the heart to maintain adequate cardiac output and systemic blood pressure during non-occluded phases while still achieving sufficient preload reduction during occluded phases to promote reverse remodeling
Solution Approach 2:
The invention applies dynamics by making the occlusion state changeable over time. The system dynamically transitions between occluded and non-occluded states, allowing optimization of both preload reduction and maintenance of cardiac output based on physiological needs
Data Source
Figure 1A~1B
Figure 2~3
Figure 4A
AI summary
Systems and methods and devices are provided for arresting or reversing the effects of myocardial remodeling and degeneration after cardiac injury, without the potential drawbacks associated with previously existing systems and methods, by at least partially occluding flow through the superior vena cava over multiple cardiac cycles, and more preferably, by adjusting the interval or degree of occlusion responsive to a sensed level of patient activity. In some embodiments, a controller is provided that actuates a drive mechanism responsive to a sensed level of patient activity to provide at least partial occlusion of the patient's superior vena cava, while a data transfer circuit of the controller provides bi-directional transfer of physiologic data to the patient's smartphone or tablet to permit display and review of such data.