Inferior Vena Cava Balloon Occlusion for Heart Failure
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Solution Overview
Problem
Current treatments for congestive heart failure, such as diuretics, nitrates, and receptor blockers, often lead to short-term improvements but are associated with side effects and renal issues, while mechanical methods like dialysis provide temporary relief, as there is no effective method to manage venous return efficiently.
Innovation Solution
A device featuring a two-way catheter with an inflatable balloon and external slots is inserted into the inferior vena cava, allowing dynamic occlusion during inspiration to regulate venous return, reducing the load on the heart and improving ejection fraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If diuretics and nitrates are used to decrease venous return, then pulmonary congestion is improved, but renal function deteriorates and side effects occur
Solution Approach 1:
The invention extracts the harmful effect of increased venous return on the lungs by mechanically occluding the inferior vena cava, separating the treatment of pulmonary congestion from renal function. The balloon device selectively blocks venous return to reduce pulmonary congestion without affecting renal blood flow or causing hydro-electrolytic disorders associated with diuretics.
Solution Approach 2:
The inflatable balloon acts as an intermediary device inserted into the inferior vena cava to mechanically regulate venous return. This intermediary approach replaces pharmacological agents (diuretics, nitrates) that harm renal function with a physical occlusion method that selectively reduces pulmonary congestion while preserving renal function.
2Object-affected harmful factors
If nitrates are used to produce venous dilatation, then venous return is reduced, but the effect is lost after a few months and headaches occur
Solution Approach 1:
The invention employs a dynamic occlusion system where the balloon can be inflated and deflated in response to respiratory cycles. The occlusion is applied dynamically during inspiration when venous return increases, and released during expiration, providing sustained long-term management rather than the temporary effect of nitrates that wears off in months.
Solution Approach 2:
The device implements periodic occlusion synchronized with the respiratory cycle - occluding during inspiration and releasing during expiration. This periodic action provides continuous management of venous return over extended periods, overcoming the limited duration of nitrate effectiveness and eliminating the need for repeated medication administration.
3Object-affected harmful factors
If mechanical methods like dialysis are used to extract corporal water, then venous return is normalized, but the effect is temporary and symptoms reappear
Solution Approach 1:
The device performs preliminary action by proactively occluding the inferior vena cava before venous return can cause pulmonary congestion. By preventing the increase in venous return rather than treating it after it occurs, the device provides sustained symptom relief without the temporary effects of dialysis that require repeated interventions.
Solution Approach 2:
The balloon device provides continuous useful action by maintaining occlusion of the inferior vena cava throughout the treatment period, with periodic release synchronized to respiration. This continuous management prevents the recurrence of symptoms that characterizes dialysis treatment, where water returns to the body and venous return increases again, requiring repeated dialysis sessions.
4Object-affected harmful factors
If an inflatable balloon is used to occlude the inferior vena cava, then venous return is regulated, but the device complexity increases
Solution Approach 1:
The invention uses a flexible inflatable balloon made of thin film material that can be inserted percutaneously into the inferior vena cava. This flexible shell structure provides the necessary occlusion function while maintaining a relatively simple device architecture compared to rigid mechanical occlusion systems, reducing overall device complexity.
Solution Approach 2:
The device employs pneumatic inflation through a catheter to achieve occlusion, replacing complex mechanical expansion mechanisms. The use of gas or fluid pressure to inflate the balloon simplifies the actuation system, reducing device complexity while maintaining effective venous return regulation through the inflatable structure.
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
This method effectively decreases pulmonary congestion and improves left ventricular ejection by dynamically regulating venous return, reducing the need for external power and allowing easy implantation and adjustment, providing sustained relief from congestive heart failure symptoms.
Implementation Method 1
A device featuring a two-way catheter with an inflatable balloon and external slots is inserted into the inferior vena cava, allowing dynamic occlusion during inspiration to regulate venous return
Data Source
AI summary
This invention relates to a method that comprises the introduction of a catheter via left subclavian vein, advancing into the right atrium and then positioning it in the inferior vena cava, just at the cava-diaphragm junction, where it is anchored at its extreme; and thereafter an external inflation of a balloon positioned in said catheter takes place through a physiological solution to reach a diameter corresponding to half the diameter of the inferior vena cava, resulting in hemi-occlusion in the expiration phase (breath-out) and total occlusion for a short period during the inspiration phase (breath-in), regulating (normalizing) the venous return and decreasing the cardiac volume overload, as a treatment for heart failure. The invention also comprises hydromechanics devices to normalize the venous return in the circulatory system. Said venous return is increased in 90% of patients with heart failure. In particular, it refers to a combined catheter with an inflatable balloon, producing said balloon a cyclical occlusion of the inferior vena cava, proximal to the right atrium (RA), which comprises of means for its fixation within said vein, as well as the capacity of modifying the volume in response to the requirements of the patient. This device is implanted for an extended period of more than three months. The final objective is to treat and stop the progression of heart failure.