SVC Occlusion Device for Heart Failure Preload Reduction
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Solution Overview
Problem
Current treatments for heart failure, particularly those targeting cardiac remodeling and reducing preload, are inadequate as they often lead to severe side effects and do not effectively address the progression of the disease, with existing device-based solutions being ineffective and pharmaceutical approaches only palliative.
Innovation Solution
The system involves regulating venous blood return through the superior vena cava (SVC) to reduce ventricular overload and cardiac preload, using a catheter with a flow limiting element and a controller to intermittently occlude the SVC, allowing for ambulatory use and minimizing risks of venous congestion and systemic blood pressure reduction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmaceutical approaches are used to reduce preload and treat heart failure, then symptoms are alleviated, but side effects are severe and disease progression is not effectively addressed
Solution Approach 1:
The patent extracts the preload reduction function from systemic pharmaceutical treatment and localizes it to the pulmonary circulation by occluding the SVC. This targeted approach delivers the therapeutic effect where needed (reducing left ventricular preload) while avoiding the harmful systemic side effects of pharmaceuticals.
Solution Approach 2:
The SVC occlusion device acts as an intermediary mechanism that indirectly reduces left ventricular preload by blocking pulmonary venous return. This intermediary approach allows preload reduction without directly administering substances that cause severe side effects.
2Reliability
If device-based solutions are used to reduce cardiac preload, then treatment effectiveness is improved, but venous congestion and systemic blood pressure reduction occur
Solution Approach 1:
The patent applies local quality by selectively occluding only the SVC to reduce left ventricular preload, while leaving the IVC patent to maintain renal venous drainage. This localized approach achieves preload reduction without causing generalized venous congestion.
Solution Approach 2:
The patent segments the venous return pathways by independently controlling SVC and IVC flow. By occluding only the SVC and keeping the IVC open, the system divides the venous drainage function to achieve selective preload reduction while preventing renal venous congestion.
3Reliability
If continuous SVC occlusion is used to reduce ventricular overload, then cardiac preload is reduced, but systemic blood pressure decreases significantly
Solution Approach 1:
The patent employs periodic action by implementing intermittent SVC occlusion rather than continuous occlusion. The occlusion is applied in cycles (e.g., 10 seconds on, 10 seconds off) to reduce ventricular overload while allowing systemic blood pressure to be maintained during non-occlusion periods.
Solution Approach 2:
The system transitions from static continuous occlusion to dynamic intermittent occlusion. The occlusion duration, frequency, and intensity are made adjustable and adaptive, allowing optimization of preload reduction while maintaining adequate systemic perfusion pressure.
4Reliability
If existing device-based solutions occlude the inferior vena cava to reduce preload, then cardiac function is improved, but renal vein pressure increases causing cardio-renal syndrome
Solution Approach 1:
Instead of occluding the IVC as in prior art, the patent inverts the approach by occluding the SVC. This reversal achieves the same cardiac preload reduction benefit while avoiding the harmful effect of increased renal vein pressure, since renal drainage through the IVC remains patent.
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.