WO1998003212A1

WO1998003212A1 - Biomechanical heart for extra-aortic diastolic balloon pumping

Info

Publication number: WO1998003212A1
Application number: PCT/FR1997/001385
Authority: WO
Inventors: Norbert Guldner; Sylvain Thuaudet; Jens Hutzenlaub
Original assignee: Ist Cardiology S.A.
Priority date: 1996-07-24
Filing date: 1997-07-24
Publication date: 1998-01-29
Also published as: EP0925079A1; FR2751549B1; AU3854197A; FR2751549A1; CA2261846A1; JP2000514687A

Abstract

A biomechanical heart comprising extra-aortic diastolic balloon pumping means consisting of a pump housing (7) arranged between two ducts (5, 9) of an aortic shunt (6) actuated by a muscle (8) energised by electric pulses. A balloon (15) with a substantially ring-shaped cross-section is inserted between the inner walls of the pump housing (7) to define an axial channel (17) communicating with said ducts (5, 9) of the aortic shunt (6). Said channel is connected via a flexible tube (19) to means (20) for injecting a gas flow into said balloon (15) to inflate same and thus reduce the cross-sectional area of flow of the axial channel (17), then deflating said balloon to increase said cross-sectional area of flow of the axial channel (17).

Description

BIO-MECHANICAL HEART WITH EXTRA-AORTIC DIASTOLIC COUNTER-PULSE

The present invention relates to improvements in bio-mechanical hearts of the type using, as a motor element, a skeletal muscle, and more particularly an extra-aortic diastolic counter-pulse system included in such a heart.

Biomechanical hearts are known which take the form of a circulatory pump capable of being completely implanted in the rib cage of a patient, in particular in cases of terminal heart failure. This pump is actuated by a skeletal muscle, for example the dorsal muscle, which is subjected to electrostimulation in such a way that all the pulsating energy of the pump comes from the metabolism of the muscle which in a way constitutes its motor.

We know that such a bio-mechanical heart has the advantage that it does not cause a rejection reaction of the organism, because the muscle is taken from the patient in which the bio-mechanical heart is implanted. In order to be able to use such a bio-mechanical core as an engine, it has proved necessary to subject it, before it is put into operation, to dynamic training. To do this, the skeletal muscle is wrapped around a device deformable training likely to contract by providing resistance to contraction, and then return to its original shape, and the skeletal muscle is stimulated, by means of periodic electrical pulses, so as to cause its contraction and that of the deformable training apparatus and their subsequent relaxation.

It has been proposed, in patent application WO 94/26326, to stimulate during a first step, the skeletal muscle by means of electrical pulses having a frequency increasing as a function of time and during a second step of gradually increasing the resistance of the deformable training device to contraction, the first and second steps possibly overlapping somewhat.

A major drawback of this system is that, in order to be fully effective, the skeletal muscle must first be subjected to the training mentioned above, so that it is effective only after a delay of the order of 8 at 12 weeks, so it can only be used on patients with pre-terminal heart failure. It cannot therefore be used on patients with very advanced heart failure requiring immediate treatment.

In the latter case, we usually use so-called intra-aortic diastolic counter-pulse systems which have the effect of increasing the coronary flow at the time of diastole and decreasing the afterload by aspirating blood from the heart at the time of systole. To set up such devices, a balloon is introduced into the patient's aorta, from the femoral artery, which is inflated at the time of diastole and which is deflated at the time of systole. The introduction of this balloon into the arterial system of the patient has the disadvantage of causing, when its use is prolonged in time, hemorrhages, infections of the ischaemias of the lower limb and femoro-iliac thromboses.

The present invention proposes to remedy the drawbacks of the two abovementioned intervention techniques by proposing a bio-mechanical heart able to be operational as soon as its implantation is carried out, so that it is able to be used on patients who have very advanced heart failure, requiring immediate mechanical treatment.

The present invention thus relates to a bio-mechanical heart of the type comprising means of extra-aortic diastolic counterpulsation constituted by a pumping cage, disposed between two conduits of an aortic bypass, the actuation of which is controlled by a muscle excited by electrical pulses, characterized in that the internal walls of the pumping cage receive a balloon, of substantially annular cross section, so as to provide an axial channel in communication with the two conduits of the aortic bypass, which is connected by a flexible tube to means making it possible to inject a gas flow capable of inflating it, so as to reduce the passage section of the axial channel and to deflate it so as to increase said passage section. In an alternative embodiment of the invention, the gas flow consists of helium.

The present invention is particularly advantageous in that it makes it possible to make a bio-mechanical heart immediately effective, without waiting for a delay in training the muscle 8. Furthermore, the extra-aortic diastolic counter-pulse system according to the invention does not require interrupting the muscular training phase of muscle 8 and can even help improve its training.

Various embodiments of the present invention will be described below, by way of non-limiting examples, with reference to the appended drawing in which:

Figure 1 is a schematic view of a bio-mechanical heart according to the prior art, used in an aorto-aortic application. Figure 2 is a longitudinal sectional view of a bio-mechanical core according to the invention.

Figure 3 is a schematic view of a bio-mechanical heart according to the invention, of the type of that shown in Figure 2, and which is implemented in an aorto-aortic application of the type of that shown in Figure 1 .

FIG. 4 is a schematic view of an embodiment, in an apico-aortic application, of the bio-mechanical heart shown in FIG. 2. In Figure 1, there is shown a heart 1 and its aorta 3, to which a branch 6 is connected, formed of a conduit 5 which starts from the upstream of the aorta 3, which passes through a tubular pumping cage 7 to emerge from it by a conduit 9 which is connected to a downstream part of the aorta 3. The pumping cage 7 is generally made up of a deformable enclosure forming a pump which is actuated by a muscle 8, in particular by a muscle skeletal type of great dorsal, which for this is wrapped around the pumping cage 7. The contractions of the muscle 8 are triggered by a myostimulator 11, itself synchronized with the cardiac movements by a sensor 13 fixed on the heart 1 to which it is connected. When the muscle 8 is not excited, that is to say when it is released, the cage 7 then has a large diameter and when the muscle 8 is excited, it is then contracted so that the passage section in cage 7 is reduced. Under these conditions, when the aortic valve 10 is closed (which is detected by the sensor 13, and which corresponds to the diastole) the myostimulator 11 sends an electrical pulse to the muscle 8, which is in synchronism with the diastole. The muscle 8 is then excited and compresses the pumping cage 7, so that the blood which passes through it is forced back both upstream and downstream. Upstream, this influx of blood increases blood circulation in the coronary arteries, and downstream it improves circulation blood flow through the aorta 3. When the aortic valve 10 is open (which then corresponds to the systole), the muscle 8 is not electrically excited, so that it relaxes and the cage 7 regains its volume, thus creating a depression which promotes blood circulation in the aorta 3.

There is shown in Figure 2, in schematic form, a bio-mechanical heart with a diastolic counterpulse which can be used in aorto-aortic applications, (Figure 3) as well as apico-aortic (Figure 4). This heart was placed in a bypass 6 created on the aorta 3 by two conduits 5 and 9, a pumping cage 7 around which was wound a skeletal muscle intended, as mentioned previously, to compress the pumping cage 7 when 'he is electrically excited.

According to the invention, the pumping cage 7 comprises on its internal surface 12, a balloon 15 of substantially annular cross section, so as to provide an axial channel 17 which is connected to the upstream 5 and downstream 9 conduit of the bypass 6. The balloon 15 is connected by a flexible tube 19 which leaves the skin after a long subcutaneous journey, to an external pressure and vacuum generator 20 able to successively create in the balloon 15 a pressure, in particular by injection of a gas such as helium, and a vacuum by suction, so, in synchronism with the diastole and the cardiac systole, to inflate and deflate the balloon 15. To ensure such synchronism, the pressure and vacuum generator 20 is in communication with the native heart 1 by a link 22 and a listening or implantable listening electrode 24. In the aorto-aortic embodiment shown in FIG. 3, the operation of the device is of the same type as that described in FIG. 1, with the difference that, instead of exciting the muscle 8 by an electric discharge in order to compress the pumping cage 7 so as to expel the blood contained in the bypass 6, the balloon 15 is inflated, by blowing helium through the line 19. Likewise, instead of leaving the muscle 8 relax, which had the effect of allowing the pumping cage to regain its volume thus creating suction through the pipe 5, a vacuum is created in the balloon 15 to retract it.

The present invention has a certain number of advantages and first of all that of making a bio-mechanical heart immediately effective, without waiting for a delay in training the muscle 8. In addition, the extra-aortic diastolic counter-pulse system according to the invention does not require interrupting the muscular training phase of muscle 8 and can even contribute to improving the training thereof. When the training phase of muscle 8 is complete, it is possible either to eliminate the tube 19 through the cutaneous orifice, or to leave it in place by cutting it flush with the skin and burying it in the sub-tissues. skin. The diastolic counter-pulse system according to the invention can also be implemented in bio-mechanical hearts with inlet and outlet valves as well as those used in the so-called apico-aortic arrangements. In this arrangement, the blood flow from the left ventricle of the heart 1 enters channel 17 at the time of systole and is ejected into the aorta 3 at the time of diastole. An intake valve 25 and a discharge valve 26 avoid retrograde flow in the left ventricle, which would be extremely harmful on a hemodynamic level. The intake valve 25 is open and the discharge valve 26 is closed at the time of systole. The inlet valve 25 is closed and the discharge valve 26 is open at the time of the diastole. The extra-aortic counterpulsation balloon 15 has the same effects in this apico-aortic configuration as in the aorto-aortic configuration. The deflation of the balloon 15 during systole, the delivery valve 26 being closed, facilitates the filling of the channel 17 where the blood is drawn due to the vacuum created. The inflation of the balloon 15 during the diastole, the inlet valve 25 being closed, allows the ejection of this volume of blood into the aorta 3 through the delivery valve 26 which is then open.

Claims

1. - Bio-mechanical heart of the type comprising extra-aortic diastolic counter-pulse means, constituted by a pumping cage (7), disposed between two conduits (5, 9) of an aortic bypass (6) of which 1 actuation is controlled by a muscle (8) excited by electrical pulses, characterized in that the internal walls of the pumping cage (7) receive a balloon (15) of substantially annular cross section, so as to provide a axial channel (17) in communication with the two conduits (5, 9) of the aortic bypass (6), which is connected by a flexible tube (19) to means (20) capable of injecting into said balloon (15) a gas flow capable of inflating it, so as to reduce the passage section of the axial channel (17) and then to deflate it, so as to increase said passage section (17).

2.- Heart according to claim 1 characterized in that the gas flow consists of helium.