Method and a catheter device for the dynamic regulation of the venous return to the heart for the treatment of patients with heart failure

Abstract

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 (IVC). The said balloon is adaptable to the area of its location in 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.

Description

[0001]This is a continuation-in-part of application Ser. No. 12 / 202,617, filed Sep. 2, 2008 now abandoned.BACKGROUND OF THE INVENTION[0002]It has been known within the field of the specialty that heart failure is a result of the increase of the venous return which causes volume overload and severe pulmonary congestion; so that the decrease of venous return (normalization) is crucial in the improvements of the symptoms of said pulmonary congestion and heart failure. In early attempts to solve the problem, bloodletting and tourniquet in the lower extremities were used as a mean to normalize venous return, to improve the pulmonary congestion.[0003]In later years, the use of mercurial diuretics started, then stronger ASA diuretics, furosemide and bumetanide helped to rapidly decrease the venous return, with improvements of the heart failure symptoms; however, there were deleterious effects on the renal function, such as hydro-electrolytic disorders and renal damages.[0004]The persistenc...

AI Technical Summary

Benefits of technology

[0017]In this way, the load conditions of the right atrium, right ventricle and left ventricle are decreased. This situation is repeated in each inspiration (breath-in), preventing an increase of the flow rate that normally occurs in each inspiration, reducing also the flow rate and the filling pressure at left and right ventricles.

[0018]As a result of this normalization of venous return, there is a decrease of pulmonary congestion on the diastolic diameters of both ventricles and an improvement in the left ventricular ejection.

[0019]This model of instantaneous and dynamic regulation of the flow has the advantage that the balloon can be easily implanted by an expert, it is possible to modify and adjust it in situ without difficulty, in order to obtain the expected results; and no external power generation is required to operate, since the flow regulation (normalization) is supported by the physiology of the patients when breathing in. Additionally, the said device can be removed without difficulties when required, by simply emptying the content of the balloon from the outside.

Problems solved by technology

In later years, the use of mercurial diuretics started, then stronger ASA diuretics, furosemide and bumetanide helped to rapidly decrease the venous return, with improvements of the heart failure symptoms; however, there were deleterious effects on the renal function, such as hydro-electrolytic disorders and renal damages.

The persistence of the problem of the increased venous return led to the use of nitride and nitrates, which produce a venous dilatation, causing a reduction on the venous return, improving the symptoms for a short period of time; but the inherent intolerance in this type of medication causes the loss of the effect in a few months, with the additional inconvenience of associated headaches as side effects, as it was observed in a large percentage of patients, resulting risky the use of these medicines during extended periods of time.

After the introduction of receptor blockers of aldosterone (spironolactona), hydro saline retention was minimized, as well as venous return; however, the receptor blockers produced serious side effects.

It was considered then that this technique caused little improvement in the ejection fraction of the left ventricle; and better results are obtained only when the venous return is diminished through diuretic administration.