Passive cardiac assistance device

Abstract

Artificial implantable active and passive girdles include a heart assist system with an artificial myocardium employing a number of flexible, non-distensible tubes with the walls along their long axes connected in series to form a cuff and a passive girdle is wrapped around a heart muscle which has dilatation of a ventricle to conform to the size and shape of the heart and to constrain the dilatation during diastole. The passive girdle is formed of a material and structure that does not expand away from the heart but may, over an extended period of time be decreased in size as dilatation decreases.

Description

[0001] This application is a continuation of U.S. patent application Ser. No. 09 / 023,592 filed Feb. 13, 1998, which is a divisional of U.S. patent application Ser. No. 08 / 581,051 filed Dec. 29, 1995 (now U.S. Pat. No. 5,800,528 issued Sep. 1, 1998), which is a continuation-in-part of U.S. patent application Ser. No. 08 / 490,080 filed Jun. 13, 1995 (now U.S. Pat. No. 5,713,954 issued Feb. 3, 1998). The contents of each of these patent applications are specifically incorporated herein by reference.FIELD AND BACKGROUND OF THE INVENTION[0002] The present invention relates to cardiac devices in general, and more specifically to passive and active cardiac girdles.[0003] Patients having a heart condition known as ventricular dilatation are in a clinically dangerous condition when the patients are in an end stage cardiac failure pattern. The ventricular dilatation increases the load on the heart (that is, it increases the oxygen consumption by the heart), while at the same time decreasing ca...

AI Technical Summary

Benefits of technology

[0015] Ventricular dilatation is a clinically dangerous condition for end stage cardiac failure patients. The output of the heart is effected by: (a) end-diastolic volume (ventricular volume at the end of the filling phase), (b) end-systolic volume (ventricular volume at the end of the ejection phase), and (c) heart rate. When (a) is very large, (b) also tends to be larger and (c) tends to be larger than normal. All three of these factors contribute to large increases in the tension-time integral and therefore to increased oxygen consumption.

[0028] To avoid the problem of potential irritability and damage to the external myocardium cells by virtue of the artificial wrap and its long term constraining contact with the myocardium, one embodiment of the invention employs a tissue engineered lining to protect the myocardium. This tissue engineered lining consists of a polymer scaffold seeded with myocardial cells harvested from the patient's own myocardium using tissue engineering technology. That lining then generates a biological myocardio-interfacing surface and remains firmly attached to the polymer interfacing with the surface from which the wrap is made. Such a lining would integrate biologically to the heart's myocardial cells in a manner analogous to other devices currently being investigated which use cell scaffolds for in vitro and in vitro tissue engineering.

[0032] It is yet another object of this invention to provide a ventricular assist device which is compact, requires relatively low energy input and does not require percutaneous components.

[0033] It is a further object of this invention to provide a passive girdle to be wrapped around a heart suffering from ventricular dilatation to limit this dilatation and thus improve the performance characteristics of the heart.

[0034] It is another object of this invention to provide a passive girdle or vest which can, over a period of time, have its diameter decreased to effect some decrease in dilatation of the ventricle.

Problems solved by technology

Patients having a heart condition known as ventricular dilatation are in a clinically dangerous condition when the patients are in an end stage cardiac failure pattern.

The ventricular dilatation increases the load on the heart (that is, it increases the oxygen consumption by the heart), while at the same time decreasing cardiac efficiency.

A significant fraction of patients in congestive heart failure, including those who are not in immediate danger of death, lead very limited lives.

This dilatation condition does not respond to current pharmacological treatment.

During ventricular dilatation the ventricular radius increases and the energy dissipated by the heart muscle just to maintain this elastic tension during diastole is abnormally increased, thereby increasing oxygen consumption.

This risk is most associated with use of artificial blood contacting surfaces.

One problem affecting thromboembolism risk in heart assists arises from the use of prosthetic, biologic or mechanical pericardial valves.

A second problem associated with implanted cardiac assist devices is the problem of infection, particularly where the implanted device has large areas of material in contact with blood and tissue.

A third problem area in ventricular assist devices is the calcification of these devices.

However, once again, the blood is exposed to the surfaces of the pump, particularly the bearing and seal area.

However, for most present ventricular assist device systems, stoppage of even a few minutes results in formation of blood clots in the device, rendering any restart of the system a very risky undertaking.

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