Process for training a skeletal muscle for a biomechanical heart

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Corporeal artificial heart – heart assist – control...

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600 16, A61M 110

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058141022

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BRIEF SUMMARY
The present invention relates to a process for dynamically training a skeletal muscle for a biomechanical heart as well as a biomechanical heart using such a muscle.
It has already been proposed to provide a biomechanical heart in the form of a circulatory pump adapted to be completely implanted in the thoracic cage of a patient, particularly in the case of terminal cardiac insufficiency. This pump is actuated by a skeletal muscle, for example the large dorsal muscle, subjected to electrostimulation such that all the pulsing energy of the pump derives from the metabolism of the muscle which serves as a sort of motor. Such a biomechanical heart, using a skeletal muscle as motor, offers the advantage that it does not involve a rejection reaction of the mechanism because the muscle which is used belongs to the patient in whom the biomechanical heart is implanted.
So as to be able to use as a motor for such a biomechanical heart, a muscle which will not tire, with so-called type I fibers, it has already been proposed preliminarily to subject the muscle to dynamic training, as is described in these publications:
N. W. Guldner et al.; "Development and training of skeletal muscle ventricle with low preload"; J. Card. Surg., 1991; vol. 6, No 1.
N. W. Guldner et al.; "Dynamic training of skeletal muscle ventricles--a method to create high performance for muscle powered cardiac assist."; Fourth Vienna International Workshop on Functional Electrostimulation; Baden/Vienna, Sep. 24-27, 1992; ISBN 3-900928-08-9 1992.
This type of dynamic drive consists in wrapping the muscle about a drive device comprising an elastically deformable element with an internal chamber filled with liquid and terminating at its ends in inflatable bladders, such an apparatus being described in the document WO-A-9205813. To ensure drive of the muscle, it is connected to a myostimulator producing periodic electric stimulation pulses and when the muscle is thus excited by an electrical pulse, it contracts, which produces a contraction of the central chamber and an expulsion of the liquid toward the lateral bladders which inflate. When the muscle is no longer excited, between two successive electrical pulses and when it relaxes, the bladders deflate and the liquid returns to a central chamber which increases in volume, and the cycle can then be repeated.
The present invention relates to improvements in this process for training a muscle permitting obtaining a substantial increase of the muscular mass and its developed power.
To this end, the dynamic training process for a skeletal muscle adapted to be used in a biomechanical heart, in which the skeletal muscle is wrapped about a deformable drive apparatus adapted to contract, whilst opposing resistance to the contraction, and then to resume its initial shape and the skeletal muscle is stimulated, by means of periodic electrical pulses so as to produce its contraction and that of the deformable drive apparatus and their subsequent relaxation, is characterized in that during a first step the skeletal muscle is stimulated by means of electrical pulses having a frequency increasing as a function of time and in the course of a second step the resistance of the deformable drive apparatus to contraction is progressively increased, the first and second steps if desired somewhat overlapping.
There is also known from U.S. Pat. No. 5,007,927 a cardiac assistance device which is actuated by a skeletal muscle subjected to a stimulus supplied by a programmed pulse generator.
It is known that, in practice, such a device is only very little effective to the extent that the skeletal muscle used is incapable of supplying sufficient power for its actuation.
The present invention proposes to overcome this drawback by using as drive muscle a muscle trained according to the training process which is the object of the application, thus having been subjected to "mechanical" transformations conferring on it the necessary power for the proper actuation of the biomechanical heart.
The invention thus also has for its object

REFERENCES:
patent: 4813952 (1989-03-01), Khalafalla
patent: 5007927 (1991-04-01), Badylak et al.
patent: 5098442 (1992-03-01), Grandjean

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