Patent Application
20200069854
The present invention relates generally to the field of cardiac, vascular system, and heart assistance devices. Applications are in those types of surgical or clinical treatment where a total or partial prosthesis is required.
One of the main medical problems is characterized by the inability of the left ventricle to relax properly and fill with blood. This is caused by the stiffening and impaired relaxation with normal systolic function, either due to hypertrophy or to processes such as fibrosis and infiltrative diseases. These changes cause high LV filling pressures, leading to pulmonary congestion and atrial fibrillation due to distention of the atrium. The treatment of patients with this named Diastolic Heart Failure is mainly empirical. The treatment includes modification of the underlying risk factors for the disease (such as hypertension and diabetes) and administration of medications used for treaty of Heart Failure with reduced Ejection Fraction (Systolic Heart Failure). To address this problem normal pressure in the four chambers of the heart is required and in the 1960s the first intent to build a total artificial heart (TAH) was by means of chambers where elastic rubber forced blood to flow under the impulse provided by an external fix compressor's air. In the early 1980s an electric device was borne in concept, in practice an operating one was possible in the middle 2000 at a great effort and cost, but with same performance as the previous ones, or about one-year survival time on the average, which hasn't increase since then. While considerable strides have been made in design of a TAH, two main obstacles to clinical success stem from the continued thrombogenic nature of the materials employed in the devices, coupled with design limitations. The surfaced thrombogenicity necessitates systemic antithrombotic therapy with the attendant risk of hemorrhage. Mayor remaining clinical complications with the TAH include infection, hemorrhage, end organ failure, thromboembolism and device dysfunction. Mayor causes of death with current TAH designs include sepsis, multi-organ failure, neurological death most likely due to thromboembolism, hemorrhage and problems with device fit. Thus, there is an actual need to overcome those problems by leaving the heart intact and use removable means as a partial or total artificial heart where the four chambers get a complementary help to function satisfactorily.
Four inflatable patches to press and contract the heart wall's chambers up to the condition of normal functioning following the dynamics of those walls with proper initial set up and automation by means of a line connecting the SA (sinoatrial node) to the external hardware providing pneumatic energy as required to one or more cardiac chambers.
These heart attachments are activated by compressed air outlet of a pneumatic source, where the potential energy applied produce expansive work against the heart walls, and the consequent kinetic energy returns working as the suction force before re-entering at the inlet of the pneumatic source completing a cycle. The air flow is different for each patch to mimic or follow the total or remaining dynamic of the natural heart with which they interact fully. The compressed air fills a pocket, pouch, as a patch to add partial, or total, force such that the atria or ventricle complete its work efficiently providing blood flow, pressure and pulsation across the vascular system to reach those points in the body that require them. In doing so, strict maximum and minimum limits must be followed not to damage the heart itself or any part of the systemic or pulmonary system or irrigated tissues or organs.
Regime is obtained by the servomotors at a 180° steps (
The Control Panel can be replaced easily by a new one at any time in seconds if there is remaining activity in the patient heart. The Control Panel can operate under water as if in an accident or sport, in these cases the Panel must be waterproofed, and with a pouch of air instead of the air circuit connected to the atmosphere in the pneumatic unit.
In and out of the assistance to a beaten natural heart: The in-operation is done by looking at the pressure gages of the patient and the output from the pneumatic unit in the control external box, the reading at the patient most probably is lower than normal, then a single valve must be activated in the control box to start from zero to add pressure to the wall of the failing chamber, atria or ventricle, slowly. Continuing sequentially with the other three (if needed) chambers. The opposite will be done if the intention is an out-operation, receding to zero the reading in the control box. Once completed the failing heart will work as a failing organ, until reconnecting the control box. DANGER: If pressure is applied and the patient pressure didn't rise, is negative or is zero, means that such applied pressure work against the heart and must be stopped immediately thou slowly. When all chambers are set to work conveniently they are put fix to provide the delivered assistance. Only a trained professional is responsible to made changes thereof, by operating the governing valves, for a new assessment and set up the operation properly or disconnect the control box, if applicable.
Security and alarms for emergencies has been taken in consideration, in particular stop by run out of range of pre-stablished rates and loss of air into the thorax cavity.
While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alterations, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended to embrace all such alterations, modifications and variations in the appended Claims, which doesn't include the patches for two reasons:
