Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Corporeal artificial heart – heart assist – control... – Having flexible diaphragm or chamber
Reexamination Certificate
2000-02-04
2003-12-30
Snow, Bruce (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Corporeal artificial heart, heart assist , control...
Having flexible diaphragm or chamber
C623S003160
Reexamination Certificate
active
06669726
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to medical prostheses, and in particular, to an artificial heart. In particular, it is conceived to satisfy the current need for creating a new and original design to achieve a Total Artificial Heart in order to replace a native sick heart in its terminal stage or as a bridge to cardiac transplantation or to be used after a heart transplantation failure.
BACKGROUND OF THE INVENTION
At present, when there is a patient with a serious heart disease, which for different reasons is nonreversible, cardiac transplantation is considered as the solution, provided that the patient gets a donor. However, in the United States, for example, there are about 60,000 patients per year under this situation and only about 6% to 10% get a transplantation due to the current difficulties to find an adequate heart donor.
A Total Artificial Heart (TAH) is recognized as a progress in case of such an extreme situation of a cardiac failure. The present generation of this kind of devices includes the use of different models. In addition, there are partial circulatory assistance devices in use, generally called Left Ventricular Assistance Systems (LVAS).
Under extreme haemodynamic failure circumstances, these devices are used at present as a bridge to transplantation. They permit to keep the patient alive while the patient awaits for the appropriate donor, preventing a serious systemic damage caused by the progressive deterioration of the haemodynamia, which can later compromise the viability of other organs if the patient gets a transplantation.
However, the present Total Artificial Heart generation has had problems. Even though these devices have kept patients alive under extreme circumstances, they have not been able to provide them with an acceptable quality of life.
Most important, due to the disagreement between the sizes of the current generation devices and the space inside the mediastinum available for the current models, i.e. the so called lack of anatomical fit, many of these devices do not place the artificial ventricular and other elements necessary for their operation in an orthotopic position. Several elements are placed outside the body and coupling of parts located both inside and outside of the human body is made through the skin. Several pathological phenomena occur, such as local infections that are later transformed into more serious infections, ascendent infections, skin ulcerations and countless problems for the patient and his/her quality of life. An example of their limitations is the need for the patient to be connected to a pneumatic console. In addition, by placing these parts outside the chest, risks and problems are increased during operation; it also causes surgical complications and problems during the postoperative period such as bleeding, hematomas, infection, and compressions.
Furthermore, due to the reduced space available within the chest, some of the devices of the present generation do not have an adequate size to produce a good final diastolic volume. Hence, often times, in order to obtain an adequate blood flow rate, these devices resort to a significant increase of the heart frequency which causes additional turbulence as a result of and increase in the the blood flow linear velocity. This situation can be the cause of more serious haematological complications, such as haemolysis and bleeding and cause a faster deterioration of the materials that form these devices. On these grounds, a better utilization of the space available inside the mediastinum to achieve a significant increase on the diastolic volume would be highly desirable.
Another type of haematological complications associated with devices of the present generation as thrombosis and embolisms. In some of these devices the internal walls of the cavities through which blood circulates have areas with stasis, corners or boundaries between the different materials of their surfaces and with stitches between them, all of which created a very high embolism risk.
The aforementioned artificial devices present haemostatic complications such as bleeding, occurring because the blood has to go through long circuits of rigid prosthetic tubes with many stitches at each end. These artificial prosthetic tubes do not respond to a need to increase the blood flow rate like native vessels do in reflex mode, i.e. by greatly increasing their diameter. This deficiency causes a larger increase in blood pressure which further stresses the above mentioned stitches and causes the present generation Total Artificial Hearts to operate under more stringent conditions.
Another important problem of these devices is their limitation to compensate the different blood volumes physiologically handled by the pulmonary circuit and the systemic circuit. To alleviate this situation, the surgeon has to create a communication between the two circuits during the implantation surgical procedure, usually making an interauricular communication. However, the size of the surgical opening, in particular and the efficacy of this procedure in general, is often questioned because of frequently occurring systemic or pulmonary hemodynamic congestions.
Accordingly, there remains a need for an artificial heart without the attendant disadvantages of conventionally available artificial hearts.
SUMMARY OF THE INVENTION
In general, the present invention comprises an artificial heart that may be implanted in orthotopic position in a circulatory system of a living being, e.g., mammals, that preferrably and anatomically fits within a mediastinum space created by removing at least the two native ventricles, said artificial heart comprising:
one right blood chamber, said right blood chamber having an elongated shape essentially directed up and back, said right blood chamber having one right inlet port for blood to enter, said right inlet port having means for attachment to the right atrium,
one posterior outlet port for blood to exit said right blood chamber, said posterior outlet port being located above and behind the right inlet port, said posterior outlet port having means for attachment to the main pulmonary artery, said posterior outlet port either including or being adjacent to the valve for the main pulmonary artery,
one left blood chamber, said left blood chamber having an elongated shape essentially directed up and to the right, said left blood chamber having one left inlet port for blood to enter, said left inlet port having means for attachment to the left atrium,
one anterior outlet port for blood to exit said left blood chamber, said anterior outlet port being located above and to the right of the left inlet port, approximately at the same height as and in front of said posterior outlet port, said anterior outlet port having means for attachment to the aorta artery, said anterior outlet port either including or being adjacent to the valve for the aorta artery,
the spatial arrangement between said blood chambers being such that, when they are simultaneously fully expanded, a part of the right blood chamber (i.e., which projects onto the anterior thoracic wall and coincides with the projection onto said anterior thoracic wall of a corresponding part of the left blood chamber) is posterior to said corresponding part of the left blood chamber.
In particular, the artificial heart of the instant invention comprises an assembly of two artificial ventricles or blood chambers, each having an inlet and an outlet. The incoming blood from the right auricle enters the right blood chamber through the right inlet port and exits it through the posterior outlet port. The incoming blood from the left auricle enters the left blood chamber through the left inlet port and exits it through the anterior outlet port.
The unique spatial arrangement of both blood chambers, inlet ports and outlet ports give the instant invention a radically better utilization of the space available inside the mediastinum after having surgically removed both native ventricles and having surgically liberated both great vessels, main pulmonary artery an
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