Artificial Heart System

Abstract

To provide an artificial heart for a human being and other creature with at least one half of a heart, to be implemented instead of or parallel to the natural heart, performing maintenance as a pump completely or partially so as to support one circulatory system or two circulatory systems of the human being or other creature.SOLUTION: Within a hard and hermetically locked shell, two chambers are provided, one blood chamber and one drive chamber. The drive chamber is cyclically filled and discharged by a pump actuated by an electric motor. Due to pressure and suction of the drive chamber, blood from the blood chamber is transported to arteries and from veins into the blood chamber. In the course of this process, the blood chamber and the drive chamber only move to the half, in a completely unstressed manner without elastic stretching or kinking. Two innovative artificial check valves ensure that the blood flows exclusively in a desired direction.SELECTED DRAWING: Figure 1a

Description

[Technical field]

[0001] This application is a continuation-in-part of International Patent Application No. EP 2020 / 052058, filed on January 28, 2020, designated the United States, and claims the benefit of priority to German Patent Application Publication No. DE 102019000611.9, filed on January 28, 2019, each of which is incorporated herein by reference in its entirety, including all tables, figures, and claims.

[0002] The invention described herein represents an artificial heart system for a human or other living organism, comprising at least one heart half which is implemented inside the body instead of or in parallel with a natural heart, or outside the human body, e.g. for a portable dialysis machine, and which maintains or supports, fully or partially, at least one blood circulatory system of the human or other living organism as a pump, and at least one drive unit and at least one control unit, preferably located outside the body. [Background technology]

[0003] There are numerous artificial hearts that are inserted into the body and driven either electrically or externally by compressed air. Due to the high energy demands of the heart, it is not possible to find an energy source that is permanently implemented in the body, so the energy source must be placed outside the body and be replaceable and rechargeable.

[0004] The available pumps, devices and units that replace or support the heart are usually of considerable size, are not easy to handle and, above all, generate noise. Moreover, these artificial hearts work with a technical pump that over time causes mechanical damage to the blood cells. Alternatively, artificial hearts utilize an elastic membrane that becomes porous and leaky after a while and eventually tears.

[0005] DE 68906403 A1 shows an artificial heart made up of two halves. Each heart half is made up of three chambers. Two elastic membranes (10 and 11) are accommodated between these chambers. With each heart contraction, the drive pump (22) presses the liquid against the membrane (11), which for its part transmits the pressure to the liquid between the two membranes (10 and 11) and from there to the membrane (10) of the blood chamber (9a). During this procedure, on the one hand, the liquid returns from the intermediate space between the two elastic membranes (10 and 11) to the storage tank (13) and, on the other hand, permeates from the blood chamber (9a) into the artery (7). During the suction of the drive fluid by the pump (22), blood flows from the venous opening (3) into the blood chamber (9a). At the same time, the liquid from the storage tank (13) returns to the space between the two membranes (10 and 11). The partition of the two liquids depends on the flow resistance of each liquid, which is different in each heart half. Thus, the required cardiac output cannot be guaranteed. This invention has serious drawbacks and problems, which to this day have not been able to be solved. For example, two motors and two pumps are placed inside the body, despite the risk of heat and fire. Furthermore, the blood chamber (9a) cannot be completely evacuated, which creates a risk of thrombosis. Synchronous operation of the motors is not guaranteed and the function of the heart valves is not described.

[0006] In addition, the blood in the artificial heart comes into contact with several different materials, and the continuous reversal of the direction of rotation of the two electric motors significantly shortens their lifespan.

[0007] DE 69820603 A1 also shows an artificial heart that is not accessible within the body, with the drive and pump located just inside the heart, with all the disadvantages mentioned above. Summary of the Invention [Problem to be solved by the invention]

[0008] The object of the present invention consists in the task of developing an artificial heart that is at least partially improved with regard to these drawbacks. It is particularly intended to make available a powerful but simple heart that operates silently, guarantees high safety standards, preferably permanently maintains or supports at least one of the two circulatory systems, is implemented inside the body of a human or other living organism or is placed outside the body and is operated by a drive and control unit located outside the body, in a configuration that allows first life-saving measures to be taken by the patient himself in case of an emergency, no matter where he is located. [Means for solving the problem]

[0009] The invention achieves this object by means of the features defined in the independent claims.

[0010] The dependent claims present advantageous embodiments of the invention.

[0011] The artificial heart which is the core of the invention is intended to maintain and / or support at least one circulatory system of a human and / or other living organism. The artificial heart comprises at least one, in particular two hermetically sealed heart halves, each with one blood chamber and one drive chamber. Furthermore, each heart half is characterized by a splittable rigid shell. The blood chamber is made available through a bag, which is arranged at least partially, in particular up to half, in a fixed state relative to the wall of the rigid shell. The second half of the blood bag moves stress-free, preferably without twisting, into the first half by the pressure arising from the drive chamber, at least partially, in particular completely, with an axisymmetrically developing bending movement. Furthermore, the drive bag is arranged at least partially, in particular up to half, in a fixed state relative to the wall of the rigid shell, and the second half is arranged back-to-back with the blood bag, which generates a bending wave developing movement, preferably stress-free, without stretching or twisting.

[0012] Preferably, the rear surfaces of the movable halves of the blood bag and the drive bag are provided with a plurality of latitudinally arranged teeth, such as bulges, formed by the accumulation of material and / or the insertion or incorporation of rigid rings, in particular interconnected like chain links.

[0013] It is particularly preferred to arrange at least one elastic pad, in particular at least one lenticular convex elastic pad, between the two bags.

[0014] The bag is preferably woven, at least in part, from biological threads.

[0015] In a useful form, each rigid shell comprises two half shells mated by positive and negative releasable interlocking connections through conical interlocking surfaces.

[0016] In a preferred form, longitudinal and transverse grooves are provided on the inner surface of the heart half or shell and are used as third chambers, particularly for containing a viscous lubricating and sealing agent.

[0017] Furthermore, it is particularly preferred that on the inner surface of the half-organ or shell, the longitudinal and transverse grooves have a connection to the outside so as to function as a third chamber for regulating cardiac output.

[0018] It is particularly preferred that the heart halves are provided with positive and negative elements so that the second half of the heart is attached to the first half of the heart with the second half rotated 180° about its longitudinal axis, whereby the two halves work together as a blood pump to maintain both circulatory systems of a human or another organism.

[0019] Preferably, at least one of the drive media is a liquid.

[0020] In a useful form, drive fluid is pumped into (and out of) the drive bag by a cylinder-piston unit, the piston rod being driven by a spindle drive comprising a spindle with a double start left and right endless loop.

[0021] The driving fluid is preferably pumped in and out of the driving bag in alternating mode by a cylinder-double piston unit, the piston rod being driven by one or two spindle drives equipped with spindles having double start left and right endless loops.

[0022] In a preferred form, the drive fluid is pumped in and out of left and right drive bags simultaneously by two cylinder-piston units, and the piston rods are driven by one or two spindle drives equipped with spindles having double-start spiral grooves extending left and right in an infinite loop.

[0023] Particularly preferably, at least one inlet valve and one outlet valve of the blood chamber are provided, which are composed of triangular or triangular rigid plates, which are arranged in a circular manner so as to pivot around a polygonal (preferably hexagonal) through hole of the valve ring.

[0024] Preferably, the valve lamella has side lamellas arranged on both sides via pivots, which fold radially outwards behind the valve lamella when the valve is closed, while completely sealing the gaps between the valve lamellas and thus increasing their bending resistance.

[0025] Instead of the lateral lamellae, it may also be useful to insert elastic elements, such as shackles, between the valve lamellae.

[0026] In another further embodiment, at least one open or flow-open lattice structure is provided in the valve ring, preferably pyramidal in shape, which serves as a support and improved seal for the valve lamellae, the opening of which is limited by the inclination of the bulging webs against the piece of pipe.

[0027] It is recommended that the valve be monitored by a small camera or optical sensor.

[0028] At least one pressure sensor is preferably installed, in particular within the hard shell, and is intended to measure the current blood pressure and transmit the result to the control unit.

[0029] It is useful to be able to (preferably manually) disconnect the mechanical connection between the drive system and the piston rod if necessary, so that the cylinder (double) piston unit can be manually operated and then reconnected, preferably by pressing a button or the like after troubleshooting.

[0030] The outer surfaces of the connections of the heart halves preferably have a positive curvature and the arteries, veins or connecting hoses are preferably loosely and non-slippery attached, preferably by means of barbs and / or negatively curved surfaces, and at least one quick release fastener, in particular with at least one safety element.

[0031] The heart according to the invention comprises at least one, preferably two, heart halves. Each heart half is hollow, characterized by a rigid shell that is hermetically sealed against air and liquids and is composed of at least two parts. Each heart half is provided with at least two chambers, one blood chamber and one driving chamber. The blood chamber is preferably entirely composed of a blood bag and maintains the blood flow of one of the two blood circulation systems based on the rhythmic pulsation of the blood bag through the driving chamber, either through the lungs or through the rest of the body.

[0032] In the filled state, the blood bag essentially fills the entire volume, in particular the entire volume of one half of the heart. The drive chamber likewise preferably consists entirely of the drive bag, the volume of which in the filled state corresponds substantially, in particular completely, to the volume of one half of the heart, and is located opposite the blood bag.

[0033] The rigid shell of each heart half is preferably three-dimensionally elliptical and is provided on at least one of its outer longitudinal surfaces with fasteners in the form of plug-in connectors which allow to fit together by an interlocking connection when two identical or equivalent halves of the heart are arranged in a mirror-inverted arrangement of 180° with respect to each other on a vertical axis parallel to the sternum. The plug-in connectors of the two heart halves have film joints parallel to their vertical mirror axis, allowing elastic angular changes between the two halves of the heart.

[0034] The entire heart is preferably constructed by interlocking positive and negative profile fasteners or by screwing together two identical or equivalent halves of the heart, each of the halves having its own closed rigid shell, one blood chamber and one drive chamber located within it.

[0035] An artificial heart designed in this way has the size and geometry of a real heart, but preferably exhibits a flatter size and geometry. One heart half preferably exhibits an ellipsoidal geometry that looks like an elliptical egg compressed at its equator.

[0036] The wall thickness of the rigid shell of each heart half is preferably a few tenths of a millimeter. Each half is composed of at least two parts, preferably two half shells, with a separation line running longitudinally through the poles, diagonally obliquely, or transversely along the equator as shown below. The separation line between the two half shells at the equator or somewhat inclined to the equator forms a circle from an ellipse with an insertion plane approximately perpendicular to the main axis of the rigid shell or somewhat inclined to the main axis of the rigid shell. The two half shells, together with the blood and drive chambers contained in them, are fitted together in an air- and liquid-tight manner or screwed or clamped to each other. For the two half shells, it is necessary to provide a step at the separation edge, preferably on the inner surface, so that both steps after assembly of the two half shells form a closed elliptical circumferential groove in their interior along their common separation gap.

[0037] This circumferential groove and other longitudinal and transverse grooves on the inner surfaces of the two half shells, which run like the meridians and parallels on a sphere, together form a third chamber through which a lubricant such as paraffin travels between the two chambers (the blood chamber and the drive chamber) and the inner wall of the hard shell.

[0038] The half shells are preferably manufactured by injection molding of biocompatible plastics and / or by three-dimensional printing or plotting of plastics or plastic / metal mixtures. If necessary, a surface layer made of a precious metal such as gold, platinum, titanium or a ceramic coat may be applied. Articles manufactured on the basis of aluminum alloys may be electrochemically anodized.

[0039] The interior of each heart half has at least two, preferably three, chambers independent of each other, namely one blood chamber for blood, one pressure-suction chamber acting as a drive chamber and, optionally, a third chamber as an intermediate space between the two aforementioned chambers for lubricant, whose volume simultaneously determines the cardiac output. All chambers are preferably arranged inside the rigid shell, either airtight against air and liquids, or alongside each other, above each other or diagonally to each other. The chambers of each heart half may also be arranged coaxially with each other. At least the blood chambers should be composed of very fine materials that are biologically compatible and guarantee tensile strength, such as silkworm or spider silk, very flexible, pliable, pliable and deformable without resistance, or very fine synthetic threads such as nylon, PET or Perlon in the form of a balloon, a bag-like pad with two cylindrical sleeves woven together, or PCU manufactured by 3D printing.

[0040] The blood bag and the drive bag or pad are preferably wetted with a viscous liquid as a lubricant, such as paraffin, preferably from the outside, preferably from the third chamber. Each bag is preferably placed on the wall of the corresponding half shell in one half provided with its connector. The other second half is preferably placed back to back with the lubricant in between and moves back and forth together in a rhythmic pulsating manner from the drive medium connector to the aortic valve or blood connector. During this cycle, the bags change their volume, preferably from close to 0 to 98% of the volume of the rigid shell, depending on the variable volume of the lubricant, without stretching, twisting or folding during this movement and deformation. The deformation of the blood bag is caused in particular by an axisymmetric bending or deformation wave that starts about 2 / 3 of the way down the second half, moving up and down over the second half, starting from the equator of the heart half, to the equator of the heart half. As will be understood by those skilled in the art, the terms "upper half shell" and "lower half shell" refer to the orientation of the half shells in a vertical human body (standing position) that is often found in anatomy books. These shell halves may also be referred to as the "first shell half" and the "second shell half."

[0041] The viscous liquid in the third chamber, preferably as a sliding layer, reduces friction between the two chambers and the inner wall of the hard shell, maintains the supple and dense structure of the tissue of the bags, and also allows for a uniform distribution of loads and pressures to the two bags. The respective amount of volume of viscous liquid between the two chambers is used for the regulation of the cardiac output per beat. For the regulation of the amount of this sliding liquid and its exchange, the third chamber is provided with a connector on the hard shell, preferably close to the equator. Starting from this connector, a thin hose is guided parallel to the drive hose from inside the body to the outside, in a corset, belt or another position on the body placed on the chest.

[0042] The blood chamber consists of a preferably oval bag, preferably woven in one piece, with a cylindrical inlet and a cylindrical outlet, like two sleeves. The blood bag is preferably placed directly in the circulatory system or in the right half of the heart in a hypoxic circulatory system to pump blood flowing from the body's muscles and organs towards the lungs, or in the left half of the heart in an oxygen-rich circulatory system to pump blood coming from the lungs towards the body's muscles and organs. The blood bag is in particular placed in the upper half shell and comprises one opening each for the blood inlet and outlet. Each opening has a check valve, an optical system with an integrated camera for remote diagnosis of the valve and at least one pressure sensor in the fixed half to measure the blood pressure.

[0043] Both connectors of the blood chambers for the artificial heart (similar to a real heart) are located in the upper zone of the rigid shell oriented towards the head. The central plane between the right and left halves of the heart, the interventricular septum (septum interventriculare cordis), is oriented almost perpendicular to the level of the breast and inclined about 5-15 ° counterclockwise to the straight spine. For both halves of the heart, the openings for the inlet and outlet of blood are almost symmetrical to the mentioned central plane, the two outlet openings, namely the pulmonary artery and the aorta, are located close to the central plane of the heart, and the two inlet openings, namely the vena cava and the pulmonary vein, are at a somewhat greater distance. In this way, the entire artificial heart can be composed of two identical halves, each rotated 180 ° to the central longitudinal axis. This configuration allows only one half to be replaced if necessary or to be inserted in parallel into a real heart as a support. The connectors of the blood bags are connected directly to the veins, so that the blood does not come into contact with any other material other than the blood bags.

[0044] A drive chamber is preferably arranged below or beside each blood chamber. The drive chamber is used to evacuate the blood chamber by generating pressure and to refill the blood chamber by generating suction in the rigid shell of the heart half. The drive chamber is also preferably made of a bag, made of an extensible material, very flexible, pliable and deformable without resistance, preferably woven in one piece and having a cylindrical connector. The connector is preferably arranged near the apex of the heart and is used for the inlet and outlet of the drive fluid, which is preferably a component of blood, for example saline or another fluid compatible with blood, for example coconut milk. As with the blood bag, one half of the drive bag (here the lower half) is always arranged on the wall of the lower half shell, while the upper half is back-to-back against the lower half of the blood bag and moves up and down with the blood bag.

[0045] In a very safe and durable form of the heart half according to the present application, it is intended to weave the extensible threads of the two bags (blood bag and drive bag) in a circumferential and longitudinal direction, similar to meridians and parallels. For each bag, the half with the connector is oriented towards the outside in the half-shell of the wall and is wrinkle-free, while the other half (the free half) is connected back to back to each other and holds an oval pad filled with gel or viscous paraffin or medicated silicone in their intermediate position.

[0046] The pad with paraffin or silicone, on the one hand, ensures a uniform and symmetrical upward and downward movement of the two halves of the bag, and on the other hand, prevents the soft bag from entering the inlet and outlet channels of blood and drive fluids at the ends of the half-shell. The pad filled with gel, while the two free halves of the bag rhythmically move upward and downward, is held in the internal space of the heart half like a piston without a rod, held in place by longitudinal threads and centered by transverse and circumferential threads.

[0047] When assembling the heart halves, preferably, the cylindrical connectors (sleeves) of the two bags are first inserted into the connectors of the rigid half-shell until they protrude from the corresponding connectors of the rigid shell. After this step is completed, a seal is installed on the lower half-shell and the two half-shells are mated. The two bags are then pressurized in turn by a gaseous medium, so that both halves of the bag are pressed against the inner wall of the rigid half-shell. The three connectors (sleeves) of the two bags are pulled back onto the circular connectors of the rigid shell. The two check valves are then inserted through the sleeves into the connectors of the blood chamber.

[0048] From now on, the connector is ready to establish a connection between the two blood veins in the upper zone and the hose in the lower drive zone.

[0049] When the vein, artery or aorta is pulled on the corresponding connector, the connection must be secured against unintentional detachment by at least one quick release, preferably made of plastic similar to a cable strap. In this way, a safe and smooth transfer of the blood flow between the vein and the blood chamber is ensured. It is also possible to sew the connector (sleeve) of the blood bag directly onto the corresponding vein or artery.

[0050] The lower half shell houses the drive chamber with its connector and a connector for the viscous lubricant, the pressure of which can be measured outside the body, which is also an indication of the blood pressure in the blood chamber.

[0051] The walls of the common contact area between both chambers (blood chamber and drive chamber) should preferably be designed in three dimensions to prevent turbulence in the blood chamber. For that purpose, reinforcing webs and struts must be attached to the outer surface of the two bags and partially located locally in the grooves and recesses present in the inner wall of the rigid shell. Their resistance determines the deformation and sequence of movements of the two cooperating chambers in the process of their operation. The partially different wall thicknesses of the blood chamber and the drive chamber in the circumferential and longitudinal directions allow to determine the elasticity and bending resistance of the walls of the bags so as to optimize the sequence of deformations during the upward and downward movement, thus ensuring a permanent laminar flow of blood entering and leaving the blood chamber, as well as a complete evacuation of the blood chamber without the formation of wrinkles due to the above-mentioned lenticular bulging.

[0052] The rear surfaces of the movable halves of the blood bag and the drive bag, which are arranged one on top of the other, are preferably formed in a flexible material, tissue or plastic, such as polycarbonate urethane, called PCU, with ring-shaped bulges, like the teeth of a three-dimensional gear with teeth and gaps, resembling parallel lines of the latitudes of a sphere, so that the teeth of one bag are inserted into the gaps between the teeth of the other bag as the two rear surfaces overlap each other and expand (unfold). The same applies for the reverse movement. The bag formed in this way can also be called a Teeth bag. In a simple configuration, the shape of the teeth is circular, like the teeth of a lantern gear. In the cross section of the vertical section, respectively, an involute or cycloid shape is also possible.

[0053] The drive chamber connector of each heart half is coupled by an elastic hose to a pump preferably located outside the body.

[0054] An artificial heart functioning in this way can also be placed outside the body: in this case, the blood chamber connector is guided into the body by an extension line, where it is connected to the veins and arteries of the old, defective heart.

[0055] The pump for the driving fluid is preferably composed of two cylinder-piston units synchronized with each other and connected in series or parallel. They are placed on the chest, on a corset or on a belt outside the body in a closed waterproof case. The pump cylinder is preferably mounted horizontally on the human or living body, the piston reciprocating along the cylinder axis, pumping the driving fluid (saline or coconut milk) from the pump cylinder to the driving chamber and vice versa. One cylinder-piston unit is provided for each half of the heart. Two units are required for a full artificial heart, and they are placed inside or around each other, parallel to each other, or in series on a common axis in a tandem configuration, or coaxially. The arrangement of these cylinder-piston units determines whether the two heart halves supply blood to the arteries sequentially or simultaneously (like a real heart).

[0056] The piston rod of the pump is reciprocated preferably by one single electric motor or by up to four electric motors in different modes in a redundant configuration. The piston rod of the hydraulic cylinder piston unit reciprocates with the help of a rotating disc and one or two eccentric strokes in addition to known pump principles such as axial and radial piston pumps and external gear pumps.

[0057] A particularly safe reciprocating movement of the piston rod can be achieved by means of useful configurations via one or two infinite spindle drives. In these configurations, one or two electric motors drive at a constant angular speed a spindle shaft with an infinite screw groove, preferably with a double start, having two right-handed threads and two left-handed threads, the rotation always taking place in one direction. The spindle drive preferably consists of a hollow spindle drum (roll), with two mutually intersecting screw grooves, with a single or preferably double start, on its circumference, having a right-handed thread and a left-handed thread, the ends of the grooves merging into each other in a tangential direction. This ensures a smooth, jerks- and jolt-free automatic transition of the spindle nut from the end of the right-handed groove to the left-handed groove and reversal of its direction of movement, without speed changes while the spindle drum is always continuously rotating in one direction.

[0058] The spindle nut consists of a hollow cylinder without threads, like a piece of pipe, which slides on the spindle drum with minimal play. Inside the spindle nut, at least one sliding block is provided in the form of a three-dimensionally curved and rounded shuttle, radially connected by a pin to the inner wall of the hollow cylinder and rotatable in both directions around the pin axis by about ±30°. Each spindle nut has a number of sliding blocks, each a shuttle, that corresponds to the number of parallel groove passages available on the spindle drum. For example, in the case of a spindle drum with two groove passages, the spindle nut comprises two sliding blocks, each a shuttle, facing each other in a 180° mirror-inverted configuration with respect to the rotation axis of the drum. The sliding blocks transfer the rotational movement of the spindle drum to a translational reciprocating movement of the spindle nut, when the spindle nut itself is prevented from rotating. The outside of the spindle nut is connected to the piston rod of one pump with one piston rod or to the piston rod of two pumps, each with its own piston rod. For this reason, the spindle nut cannot rotate around its own axis. The mechanical connection of the piston rod to the spindle nut is made by a manually actuated coupling. In case of an emergency, for example during a failure of the electric drive, this connection can be separated by simply pulling a button, thus releasing the coupling. The piston rod and therefore the pump can then be operated manually.

[0059] In the case of two or more drive motors and spindle drives, it is recommended that the spindle drums are coupled to one another, for example by gears.

[0060] The real heart valves are preferably replaced by innovative prosthetic valves that are inserted into the connectors of the openings for the inlet and outlet of blood into the sleeve of the blood bag. The valves are not only used in artificial hearts but also in particular represent separately manufactured and replaceable modules. These innovative articles can be produced by plastic injection, injection molding or 3D printing. They are used in many industrial sectors as check valves that function without an external energy supply, in medical technology as a replacement for heart or venous valves and in the building sector as check valves that prevent water or sewage from flowing back into waterways or domestic lines.

[0061] They comprise several, at least three, preferably six, triangular, in particular equilateral triangular, lamellae which are attached with their third side to the edge of a polygonal, preferably hexagonal, through-hole of the valve ring, in particular to the edge of such a bore, by means of a joint, preferably a film joint. Each blood chamber has two valves. The valve rings are housed in steps of the openings of the upper half-shell, each perpendicular to the blood flow.

[0062] The step ends in the blood inlet opening, i.e. at a greater distance to the blood chamber, and starts in the blood outlet opening. To enable the valve lamella to close tightly during backflow of blood, the two isopod faces of the lamella are each rotatably connected to a separate triangular lateral lamella, the acute angles of which are located at the corners of the polygonal or hexagonal through-holes or bores of the valve ring.

[0063] In the closed state, the valve lamellae form a three- or multi-sided, e.g. six-sided pyramid, and in the open state a half-pyramid up to a multi-sided (in this example 12-sided) cylinder. In the closed state of the valve, the face of the lateral lamellae opposite the acute angle forms a star with three to several (in this example six) radial double blades. In order to allow the valve lamellae to close quickly and safely during the backflow of blood, a bow-shaped spring element is provided between the back of the valve lamellae and the valve ring, which permanently exerts a closing force on the valve lamellae.

[0064] Another variation of the valve does not have side lamellae. In this configuration, the arc-shaped spring elements are preferably attached to each of the two adjacent valve lamellae.

[0065] An interesting and useful variant of the valve features a honeycomb-shaped open pyramid used as the valve ring. In the closed state, the valve lamellae are placed in triangular openings in the faces of the pyramid of the valve ring. Towards the outside, the openings of the valve lamellae are limited by material protrusions on the back side of the valve lamellae (placed on the valve tube).

[0066] All three variations of these valves can be opened and closed automatically by blood flow, without the supply of external energy.

[0067] A heart or a heart half based on this design must preferably be pre-assembled in a clean room under corresponding sanitary conditions. The drive chamber as well as the pump are filled with the drive fluid and vented. The connectors for the lubrication and conditioning medium are also connected to the storage tank, which is filled and vented. The artificial heart can then be installed in the body of a human or another living organism and replace the real heart. First, the vena cava must be connected to the blood inlet opening of the right half of the heart, then the blood outlet opening of the right half of the heart to the pulmonary artery. After that, the pulmonary vein is connected to the blood inlet opening of the left half of the heart, then the aorta is connected to the blood outlet opening of the left half of the heart. If this sequence is followed correctly, subsequent venting of the ventricles is no longer necessary.

[0068] The current value of the blood pressure is preferably provided by a pressure sensor located within the blood chamber. The pressure of the lubrication and regulating medium can be measured in its connector or in a tank outside the body. The direct value of the systolic blood pressure or an indication of its value is provided. Valuable information about the state of the valves of the artificial heart can also be provided by a miniature camera in front of the valve module by optical transmission via a fiber optic cable.

[0069] All modules located outside the body are preferably housed together in a waterproof case with a small computer. Sensors transmitting information about the current blood pressure, heart rate, valve status and cardiac output to the computer are supplemented with sensors transmitting oxygen content and respiratory rate. Based on this information, the computer calculates the required blood flow and pulse rate and regulates them.

[0070] The following diagram shows a schematic diagram. [Brief description of the drawings]

[0071] [Figure 1] FIG. 1 shows a longitudinal section through the three-dimensional elliptical designed rigid shell of the artificial heart half composed of two half shells. [Figure 1a] FIG. 13 is a detailed view of the plug connection of the two half shells of one half of the heart (including its seals). [Diagram 2] FIG. 2 is a view from below of the left half of the heart shown in FIG. 1 with a film joint (B) and two positive and negative shaped fasteners. [Diagram 3] FIG. 1B is a bottom view of the two equal halves of the heart (1R and 1L) assembled by fasteners to form a complete heart. [Figure 4] FIG. 4 is a longitudinal section through the two identical halves of the heart (1R and 1L) along the plane (H) of FIG. 3. [Figure 5a] The figure shows one heart half (1) with blood and actuation bags (12 and 13), two valves replacing the heart valves (17A and 17V), two optical sensors (21A and 21V), and a blood pressure sensor (22). [Figure 5b]It shows one heart half (1) with blood and actuation bags (12 and 13), two valves replacing the heart valves (17A and 17V), two further optical sensors (21A and 21V) and a blood pressure sensor (22). The free and movable extremities of the blood and actuation bags are connected to a lenticular pad (50) which moves up and down parallel to itself between its two end positions, covering the connector bore of the half shell each time at the end of its movement. [Figure 5c] FIG. 1 shows one heart half (1) with blood bag and drive bag halves (12 and 13) stacked on top of each other, characterized by a ring-like or elliptical bulge. [Figure 5d] FIG. 1 is a partial cross-sectional view of blood bag and actuation bag halves (12 and 13) stacked together with protruding bulges (61 and 62). [Figure 6] FIG. 1 shows the entire artificial heart, which is composed of two identical halves (1R and 1L). [Figure 7] FIG. 1 shows a prosthetic check valve with six blades as closed valve flaps for use in an artificial heart as a replacement for a heart valve, shown in three views (a, b and c). [Figure 8] 8 is a view of the artificial check valve shown in Figure 7 in an open state, shown in three views (a, b and c). The six blades, together with the twelve lateral blades, form a collapsible and lockable tube. [Figure 9] FIG. 1 shows a simple prosthetic check valve in the closed state that can be used as a heart valve, shown in three views (a, b and c). [Figure 10] 10 is a diagram of the open state of the simple artificial check valve shown in FIG. 9, shown in three views (a, b and c). [Figure 11]FIG. 1 shows an electrohydraulic pump unit having a double piston-cylinder unit in tandem configuration driven by an electric motor and two spindle drives arranged on either side of the cylinder as redundant drives, shown in three views (a, b and c): (a) is a top view of the three interconnected units, (b) is a side view of the three interconnected units and (c) is a longitudinal section view of the three interconnected units. [Figure 12] The figure shows a motor gear as a drive for a pump in a drive chamber. The electric motor rotates a drum, which acts as a spindle, continuously in one direction. A spindle nut in the form of a sleeve with two internal slides reciprocates on the drum and drives the piston rod of the pump by a manually actuated coupling. [Figure 13] FIG. 1 shows a spindle drive spindle with a double-groove helix running on the left and right sides in an endless loop and a connector coupling on both sides for a single-sided or double-sided drive of the spindle. [Figure 14] Three views (a, b and c) of an electrohydraulic pump unit having two cylinder-piston units operating cyclically in a common mode and a spindle drive arranged between the pumps and driven by an electric motor and used as a drive: (a) is a top view of the three interconnected units, (b) is a side view of the three interconnected units and (c) is a longitudinal section of the three interconnected units. [Figure 15] Four views (a-d) showing a simple and safe form of artificial check valve, used as heart and venous valves and also in other industrial sectors, e.g. in the sewing sector: (a) is a perspective view showing a valve with six valve lamellae in the closed position, (b) is a cross-sectional view through the centre of two valve lamellae facing each other, (c) is a view showing a valve (51) with six closed valve lamellae without a case, and (d) is a top view of the honeycomb-shaped lattice structure of the valve without the valve lamellae. [Figure 16]A cross section through the mechanical coupling (39a) perpendicular to the piston rod according to FIG. 11 is shown in (a), and a cross section through the mechanical coupling (39b) perpendicular to the piston rod according to FIG. 14 is shown in (b). [Figure 17] FIG. 13 shows venous and arterial quick connectors to heart half-shell connectors. [Figure 18] FIG. 1 illustrates a seamless blood bag with a thickened lower half in the shape of a sickle or parabola. [Figure 19] FIG. 13 shows a seamless drive bag with a thickened upper half in the shape of a sickle or parabola. [Figure 20] FIG. 1 shows a seamless blood bag having a lower half with gears. [Figure 21] FIG. 13 shows a seamless drive bag having a geared upper half. [Figure 22] FIG. 1 shows an artificial heart with a parabolic thickened blood bag pulsating synchronously during systole. [Diagram 23] FIG. 1 shows an artificial heart with a parabolic thickened blood bag pulsating synchronously during diastole. [Figure 24] FIG. 1 shows an artificial heart with geared blood bags and drive bags that pulsate synchronously during systole. [Diagram 25] FIG. 1 shows an artificial heart with geared blood bags and drive bags that pulsate synchronously during diastole. [Figure 26] FIG. 1 shows an artificial heart with a parabolic thickened blood bag that pulsates asynchronously during systole. [Figure 27] FIG. 1 shows an artificial heart with a parabolic thickened blood bag that pulsates asynchronously during diastole. [Figure 28] FIG. 1 shows an artificial heart with geared blood bags and drive bags that beat asynchronously during systole. [Figure 29] FIG. 1 shows an artificial heart with geared blood bags and drive bags that pulsate asynchronously during diastole. [Diagram 30] Shows a double piston pump unit consisting of a piston rod with pistons on both ends without sealing. Each piston has a case with a cylindrical working chamber and a relief valve on both sides. The numbers of identical parts are always the same. Indications with letters indicate different versions or sizes of the same element. The letter references are as follows: A: Artery L: Left side of the patient V: Vein R: Right side of the patient DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0072] According to FIG. 1, the rigid shell of one heart half (1) is of three-dimensional ellipsoidal geometry, whereby a cross section through a plane (E) perpendicular to the longitudinal axis (A) represents a flat ellipse. The rigid shell of the heart half is preferably composed of two half shells, the upper half shell (2) having inlet (4) and outlet (5) openings for blood and the lower half shell (3) having inlet and outlet (6) for the drive medium as well as inlet and outlet (7) for lubricants and regulators for the cardiac output (V). The upper and lower half shells with connectors are preferably manufactured by injection molding or three-dimensional printing and are composed of biologically compatible plastics with polished surfaces, preferably coated with precious metals. At their free elliptical edges close to the plane (E), they are characterized by positive and negative shapes with preferably conically inclined surfaces that are superimposed on each other during assembly, as shown enlarged as a detail in FIG. 1a. In the center of one of the conically inclined surfaces of the interface of the two half shells, a groove containing a sealing ring (10), preferably an O-ring, is arranged, which hermetically seals the two half shells against air and liquids.

[0073] During assembly of the two half shells (2 and 3), the lower edge (8) of the upper half shell (2) is inserted over the edge (9) of the lower half shell (3) and pressed firmly around the oval edge.

[0074] On the mid-plane of the heart (C), the two half-shells (2 and 3) have a pluggable elastic double connector made up of two cylinders (11a and 11b) placed one on top of the other. The two cylinders are respectively positive, i.e. solid, and negative, i.e. hollow, making it possible to establish an interlocking connection between the two identical halves of the heart, positioning them rotated by 180° relative to the mid-plane of the heart (C). In this way, a completely artificial heart is formed. Tapering the connecting straps to each other along the axis (B) forms a film joint, which increases the elasticity and flexibility between the two heart halves. This allows the two heart halves to adapt to the individual curvature of the chest and remain movable relative to each other inside the body.

[0075] The heart half shown here represents the left half of the artificial heart. Rotating 180° around the axis of one of the straps (11a and 11b) results in the right half of the heart. Inside the blood inlet (4) and outlet openings (5), respectively, there are steps for accommodating the valves and bores (21a and 21v) for accommodating a miniature camera or a light or laser light reflection system of an optical sensor. These transmit signals, for example via glass fibers, for monitoring and remote diagnosis of the valve when used as an artificial heart valve.

[0076] The inlet and outlet (7) for the lubricant and regulator enter through the bore (20) into the interior of the heart half (1), preferably into the lower half shell (3) and into the elliptical ring-shaped gap (23) between the two half shells (2 and 3). From there, the lubricant and regulator is distributed into meridian- and latitudinal grooves (23a and 23b) on the inner surface of the two half shells, between the two bags, the blood bag and the drive bag. The hole (22) in the upper half shell (2) is used to mount a pressure sensor, which measures the blood pressure directly at that location, in the blood chamber when it increases, and transmits the result by a signal line to the central control unit.

[0077] Figure 2 shows a bottom view of the left half of the heart. The outer ellipse represents the contour of the upper half shell (2) which grips by its edge (8) behind the edge (9) of the lower half shell (3). See Figure 1A. Part of the blood inlet (4) and outlet openings (5) are visible through the connector (6) of the lower half shell (3).

[0078] A connector (7) is shown on the right side of Fig. 2, at the bottom of the half shell (3) on the plane (H). The bore of this connector (7) leads tangentially into the elliptical groove (23) between the two half shells (2 and 3) inside the heart halves and is used for the supply and discharge of a lubricant such as paraffin, which ensures the tightness and flexibility of the two bags, reduces their mutual friction and regulates the cardiac output. The left side of Fig. 2 shows, on the mid-plane (C) of the heart in each half shell (2 and 3), a tapering section as a film joint (B), as well as a pluggable elastic double connector (11a and 11b) consisting of two preferably cylindrical positive-shaped fasteners (11a) and negative-shaped fasteners (11b).

[0079] Figure 3 shows a bottom view of two identical heart halves (1R and 1L) that are mutually rotated 180° relative to the midplane of the heart (C) and assembled to the whole heart by inserting the positive fasteners (11a) into the negative fasteners (11b).

[0080] Figure 4 shows a longitudinal section of the two half rigid shells (1R and 1L) of the total artificial heart. The two identical halves are assembled by the interconnection of their positive and negative elements (11a and 11b), rotated 180° relative to the midplane of the heart (C).

[0081] FIG. 5a shows in longitudinal section one half-heart (1) made up of two rigid half-shells (2 and 3). The upper half-shell (2) is provided with a blood chamber (12) with two inlets and outlets (15 and 16). The blood chamber (12) is made up of a very elastic material such as silicone or polyurethane, but is preferably woven from biological fibers such as spider or silkworm silk. The blood chamber is preferably woven in one piece from this very extensible and highly elastic material in the form of a bag with half the volume (V) of the heart with two inlets and outlets (15 and 16) as a sleeve for the blood bag, which is inserted into the upper half-shell (2) when in the open state. It is also possible to glue the blood chamber in its entirety or in a partial range, i.e. above the equatorial level (E), to the inner surface of the half-shell, so that the blood chamber does not fold during its operation and does not tear off the camera (21A and 21V) and the pressure sensor (22) from the wall. In the blood inlet and outlet openings (15 and 16) of the blood chamber, valves (17A and 17V) are installed as artificial heart valves, and the material or tissue of the inlet and outlet (sleeves (15 and 16)) is clamped together with them between the heart valve and the openings (4 and 5) of the upper half shell (2). The inlets and outlets of the blood chamber protrude from the rigid half shell (2) sufficiently to be directly sewn to the corresponding veins and arteries, or to be connected by extension and / or by clamps and / or screws and / or adhesive connections. At the inlets and outlets of the upper half shell, preferably at the end of the blood chamber in front of the valves, cameras (21A and 21V) or optical and pressure sensors (22) are installed. Their cables are guided parallel to the supply hoses (18 and 19) from the chest outwards to the control unit.

[0082] The lower half shell (3) houses the pressure-suction chamber (13), which together with its sleeve (49) is manufactured in one piece like a bag and consists of an extensible and very elastic material such as silk or plastic thread. Its shape and volume correspond to the heart half (1). This chamber (13) is glued to the inner wall of the lower half shell (3), usually up to half way. This chamber is filled by means of a connector (6) and a hose (18) with a liquid medium compatible with blood, similar to plasma. As a driving medium it is possible to use saline solution or coconut milk.

[0083] A pump unit attached to the chest or corset, preferably located outside the body, pumps the drive medium through an elastic hose (18) to the connector (6) into the drive chamber (13). This bag or balloon in the drive chamber presses the bag or balloon in the blood chamber (12), forcing blood through the left valve (17A) located in the left half of the heart (shown here) into the aorta or the pulmonary artery in the right half of the heart. Meanwhile, the valves (17V) in the pulmonary veins in the left half of the heart or the vena cava in the right half of the heart automatically close. As the drive medium is expelled from the drive chamber (13) by the pump unit, suction is created in the intermediate space (14) between the blood chamber and the drive chamber. This suction draws the blood chamber towards the drive chamber, increasing its volume. This effect closes valve (17A) and simultaneously opens valve (17V), resulting in the inflow of oxygen-rich blood from the lungs into the blood chamber.

[0084] In the intermediate space (14) between the blood chamber and the drive chamber, as well as in the longitudinal and transverse grooves (23a and 23b) on the inner surface of the rigid shell, a lubricant such as paraffin is provided, which is intended to reduce friction between the two chamber walls and the rigid half shells (2 and 3), thus increasing the life of the material of the two chambers and the threads of the bag, keeping them dense and flexible. The filling amount of this lubricant determines the cardiac output of the heart halves and ensures its variability at a constant pulse rate. The regulation of the filling amount and the exchange of the lubricant are carried out by the connector (7) and the hose (19). The bore (20) of the connector (7) leads to the intermediate space (14) between the two blood chambers and the drive chamber, as well as to the elliptical ring-shaped gap (23) between the two half shells (2 and 3) on the plane (E). From its position, the lubricant is distributed in the grooves (23a and 23b) and between the two blood chambers and the drive chamber.

[0085] By means of an elastic hose (19) the connector (7) is connected to a hose (18) which is led outwards from the body through the opening in the chest to a storage tank arranged in the case of a pump and control unit.

[0086] One half of each bag (12 and 13) is always attached to the inside of the half shell (2 and 3). The other free halves of the bags are placed back to back and move rhythmically up and down together.

[0087] Figure 5b shows a longitudinal section of one heart half (1) composed of two rigid shells (2 and 3), in which a lenticular and elliptical shaped pad (50) filled with a gel such as paraffin or medical silicone is placed between the two mobile halves of the bag located back to back. The pad is placed centrally and perpendicular to the longitudinal axis (A) of the heart half. Guided by the threads of the two halves of the bag, the gel pad (50) moves permanently parallel to itself like a piston without a rod. In its final position, the pad closes the openings of the rigid shells to prevent any part of the bag or the balloon from penetrating into these openings or valves. The material and threads of the two bags are always unstressed and unloaded, no tensile forces, pressures or torsions act on them. The bag always floats up and down between the two liquids with the flow, respectively. The forces acting on the two faces of the bag are always approximately identical. This allows to achieve a maximum biological lifespan of the materials used.

[0088] FIG. 5c shows the heart half according to FIG. 5a. The rear faces of the halves of the drive bag and blood bag (12 and 13) superimposed on each other are equipped with circular or elliptical bulges or reinforcing rings (61 and 62) in the form of teeth, manufactured during the 3D printing of the bag from plastic or by inserting tooth-like inextensible rings made of plastic or spring steel into the tissue during the weaving process of the bag. In the vertical cross section, the shape of the teeth can be a circular arc (as shown here), but also cycloids, involutes or simpler shapes are possible. In this way the bag becomes a toothed bag up to half way. In this way, the outside of each bag will be provided with a gear-shaped group of inextensible circular or elliptical rings (61 and 62). These rings will be bent together, starting from the first bulge at the apex, with the teeth entering the gaps between the teeth, up to the valves (17A and 17V), thus creating together a moving wave. The tooth rings move together along the walls of the half shells (2 and 3) to the equator, without stretching or folding, and are positioned at their intended locations on the walls of the half shells like the parallels on a sphere. These rigid teeth or rings (61 and 62) also prevent the ends of the bag from penetrating the openings in the heart halves (4, 5 or 6).

[0089] Figure 5d shows a small section of two blood bags and a drive bag (12 and 13) stacked on top of each other, where a simple lantern gear toothed circle is provided in vertical cross section. The chain (61) with black links or teeth represents a cross section through the blood bag (12), and the chain (62) with white links or teeth represents a cross section through the drive bag (13).

[0090] Figure 6 shows a longitudinal section of the artificial heart according to the invention, which is made up of two identical halves (1R and 1L). The upper zone contains, from left to right, valves (17VR, 17AR, 17AL, 17VL) replacing the tricuspid, pulmonary, aortic and mitral valves. The lower zone is provided with connectors (7R, 6R, 6L, 7L) with supply lines (19R, 18R, 18L, 19L) for lubrication and driving agents. These supply lines are guided outwards from the chest together with the cables (23R and 23L) of the camera (21VR, 21AR, 21AL, 21VL) and the blood pressure sensor (22R and 22L) and are connected to the pump and the control unit outside the body.

[0091] FIG. 7 shows three views (a, b and c) of a closure valve (17) according to the invention, which functions as a prosthetic heart valve. The valve is composed of at least three or more (n), preferably six, thin lamellae (24) made of a solid material, such as plastic, pivotally attached in a circular configuration to a polygonal bore of a valve ring (26) by film joints (25). The valve lamellae (24), also called main blades, are triangular with two sides (27) of equal length, an intermediate acute angle (a) and a short side (25) opposite this acute angle, formed as a joint, for example a film joint. The angle (a) is usually less than 1 / n of 360°, (n) indicating the number of lamellae. Each valve lamella (24) is inclined with respect to the plane of the valve ring (26) from about 90° in the open state to a value of (β) in the closed state. The latter value should preferably be chosen between 45° and 60° to ensure safe functioning and a long life. On either side of each leg of the isopod valve lamella (24), a further thin triangular rigid lateral lamella (28R and 28L) (also called lateral blades) is pivotally attached, preferably by a film joint (27), as shown here. The left lateral lamella of each main lamella is also pivotally connected to the right lateral lamella of the adjacent main lamella, also preferably by a film joint. Each left lateral lamella represents a mirror image of the right lateral lamella. This means that between the adjacent valve lamellas of a closed valve, one left lateral lamella and one right lateral lamella, respectively, are arranged in harmony with each other and are oriented radially outwards. In this position, the lateral lamellas (28R and 28L) reinforce the valve lamella (24) against bending caused by blood pressure. Moreover, they close the gaps between the valve lamellas, thus ensuring excellent tightness of the valve. To allow the valve lamella (24) to always close automatically, a spring element (30) may be optionally added, preferably in the form of a partial cylinder made of the same material. The backflow of blood together with the blood pressure increases the speed and force of the valve closing as well as its tightness. The dimensions of the lateral lamellae determine the position of the valve lamellae in the open state, respectively the width of the valve opening. The location of the attachment of the joint to the edge of the rigid blade at the inner or outer edge determines whether the lateral blade is guided to the front or rear side of the valve during valve closure.This is essential for the valve to function properly.

[0092] The valve (17) is preferably manufactured in one piece by three-dimensional printing of plastic or a mixture of plastic and metal powder.

[0093] Figure 8 shows three views (a, b and c) of the valve (17) in the open state. The valve consists of a valve ring (26) with a hexagonal bore and six rigid valve lamellae (24) pivotally mounted on the six edges of the hexagonal bore. By means of film joints (25), the valve lamellae are pivotally positioned on the six edges of the hexagonal bore of the valve ring (26). A spring element (30) between the valve lamellae and the valve ring allows the valve lamellae to close automatically in the rest position without blood flow.

[0094] Between each of the two rigid valve lamellae, two triangular or triangular rigid lateral lamellae (28R and 28L) are provided in a mirror image arrangement with respect to each other, with their tips pointing towards the valve ring (26). These lateral lamellae are pivotally connected to each other and to the valve lamellae by joints, preferably film joints (27 and 29). The lamellae have different wall thicknesses, the maximum thickness being located in the center of the lamellae respectively and decreasing towards the joints. As for the valve lamellae (24), the joints (25) are attached to the valve ring (26) at their inner edges to allow them to tilt inwards, i.e., about 45° to the center of the valve, from an almost vertical position to a closed position. The joints (27) on the two other faces of equal length of the valve lamellae are located on the outwardly directed edges of the two valve and lateral lamellae. They move towards the outside by about 45°. Between the two lateral lamellae (28R and 28L) which are interconnected in a mirror image configuration, a joint (29) is attached to the inner edge of the rigid lateral lamellae so that during valve closure, these lateral lamellae automatically rotate inwards and end up completely overlapping each other. The wall thickness of the lateral lamellae is also not uniform. The narrow outer edge which represents the valve outlet is thicker than the tip close to the ring (26).

[0095] The joints of the side lamellae are preferably only partially shaped like halves of a piano hinge to prevent or at least reduce material build-up at corners where several valve lamellae meet, with or without side lamellae.

[0096] The valve lamella and the side lamella exhibit an easily measurable and clearly visible thickness with two edges to clearly identify each of them in the face with the film joint. One edge is provided in the form of a resilient film joint, while the other edge acts as an angular limit of the pivot. This mechanism is advantageously configured so that the valve provides a defined and safe mobility and movement cycle as well as a stable operation.

[0097] Figure 9 shows three views (a, b and c) of a simple version of the closed valve (17b). The valve consists of only three parts (24b, 26b, 30b). The rigid valve lamella (24b) is attached to the valve ring (26b) in a pivoted configuration by a film joint (25b). A semicircular spring element (30b) for this valve is mounted between two adjacent valve lamellas. The entire valve (17b) is manufactured in one piece by three-dimensional printing composed of plastic or a mixture of plastic and metal powder.

[0098] Figure 10 shows three views (a, b and c) of the valve (17b) in the open state. The equal length sides (27b1 and 27b2) of the rigid valve lamellae (24b) are formed positively and negatively (convexly and concavely) on the left and right sides, so that they slide one inside the other not only during closing but also after closing. This prevents spillage or breakage of the individual valve lamellae and thus ensures the tightness of the arrangement.

[0099] FIG. 11 shows in three views, top view (a), side view (b) and longitudinal section (c), a pump unit with a tandem cylinder-double piston unit (31, 32L and 32R) as a pump and two spindle drives (40 and 42) for transmission driven by two to four electric motors (M1, M2, M3 and M4) arranged on both sides of the pump. The pump has a cylindrical case (31) that houses a cylinder bore with double pistons (32R and 32L), piston seals (33) and a common piston rod (34a). In front of each working space (VR and VL), the pump has connectors for the drive fluid on both sides. Through the connectors, the drive fluid flows alternately through lines (18R and 18L) into the drive chambers of the two heart halves, squeezing blood from the blood chambers into the pulmonary artery or into the aorta. If the blood chamber of each heart half is intended to simultaneously or cyclically squeeze blood into the artery and the aorta, then two pumps (i.e. one piston each) in a simple version must be placed in parallel on either side of the motor gearing, the piston rods being attached to the gearing of the drive unit by means of a manually switchable coupling.

[0100] In the cylinder space, the piston rod (34a) is provided with two bearings. In the cylinder space between these bearings, a ring-shaped element (35) is provided, which acts as a drive for the piston rod (34a). On both sides of this drive member (35), coupling elements (36) are provided which protrude from both sides of the pump case through two slots, and which are used for driving by a gearing driven by an electric motor, such as a spindle drive, a worm drive, a crank drive, an eccentric drive, a slider crank mechanism, a rope, a belt and chain drive, or other known driving mechanisms. Furthermore, the ring-shaped element (35) has a pin (38) as an arm which rises vertically towards the outside and protrudes through the slots from the pump case perpendicularly to the piston rod between the two coupling elements (36). The arm (38) is used as a fixing and guide for the manual coupling (39) and, in cooperation with the coupling, is also used for manual actuation of the piston rod (34a) after failure of the electric drive.

[0101] The coupling (39) comprises a handle with a round button at its end. By pushing the handle up or down, the connection between the piston rod (34a) and the driven element (42) of the gearing is disengaged or reengaged by shifting the tip of the coupling (39) outward from or reinserting it into the recesses (37 and 47) of the coupling elements (36 and 46). As soon as the coupling (39) is disengaged, the artificial heart can be further manipulated by manually moving the handles and arms (38 and 39) towards the right and left.

[0102] In a simple configuration, the pump is driven by one or two electric motors (M1 or M2) and a gearing that transfers the rotational motion of the electric motors to a reciprocating translational motion. The driven element (42) of the gearing that translates the translational motion comprises a coupling element (46) having a recess (47) like the recess (37) of the driving element of the piston rod.

[0103] FIG. 12 shows a preferred drive variation of the pump, consisting of an electric motor (M) driving a cylindrical body (40) as a spindle with a constant angular velocity in one direction, by a coupling (48) with a one-way clutch, such as a drum with grooves. The cylindrical surface of the drum is provided with two grooves (41) of opposite direction, running tangentially inwardly towards each other, in the form of right and left helices, in a double start configuration. The helices of each groove, right and left, form an infinite self-contained loop. The two infinite loops are arranged on the surface of the spindle rotated 180° with respect to the rotation axis of the drum. Above the drum, in a coaxial orientation, a sleeve (42) is provided as part of the spindle nut. The sleeve is provided on both sides with coupling elements (46) in the form of protruding material, which may be dovetailed or may be provided with recesses (47) or bores. The protruding coupling element (46) is used on the one hand as an anti-twist protection for the spindle nut and on the other hand for engaging and disengaging the electric drive of the cylinder-piston unit with the pump.

[0104] The sleeve (42) further comprises one or two mutually opposed radial bores with bore axes (45), one or two bearing pins (44) rotatably mounted in the bores, and one or two sliding bodies (43) or shuttles, which act as nut blocks, each of which has one of the bearing pins (44) fixedly inserted therein. The sliding bodies (43) are rounded on all sides between the three sides of the spiral groove (41) and the sleeve (42) and rotate about ±15° around the pin axis (45). The sliding bodies are therefore also called shuttles. After assembly of the pump, the sleeve (42) is prevented from rotating by the coupling (39). Thus, the sleeve translates along its longitudinal axis, so that the sliding blocks (43) slide smoothly without counter-helical jerks until they reach the end of the groove helix and reverse the direction of movement of the sleeve. In the case of a right-left spiral and a 180° displacement of the double start of the groove passage, the two sliding bodies run in a mirror-inverted relationship as groove blocks in the groove passage and transmit the forces symmetrically from the drum to the sleeve.

[0105] FIG. 13 shows a drum (40) with a spiral groove (41) of the double start (1 and 2) type, which always rotates in one direction. The groove paths (1 and 2) each form an infinite loop of their own, one running on the right side (1R and 2R) and one running on the left side (1L and 2L), smoothly and without jerk, merge at the beginning and end (E1 and E2) of their groove paths (1R and 1L) and (2R and 2L) and at the same time change their direction of movement. The left and right paths of each groove loop (1 and 2) are in a mirror-inverted relationship with respect to the planes (F and G). The groove loops (1 and 2) are displaced by a rotation angle of 180° so that the path (1R) with (2L) and the path (2R) with (1L) are in a mirror-inverted relationship with respect to the plane (F).

[0106] One slide (43) is provided for each groove loop (1 and 2). Two slides will be provided at each position of the spindle (40) opposite each other in a mirror-inverted relationship with respect to the rotation axis of the spindle. The spindle is provided with bearing journals on both sides and coupling elements (48) with one-way clutches to ensure safe bearings and redundant drives on one or both sides.

[0107] FIG. 14 shows, in three views a, b and c, a pump unit in which two cylinder-piston units (31b, 32L, 32R) are independently arranged in parallel.

[0108] The pump unit comprises a case (31b) having two cylinder bores arranged adjacent to each other and housing two pistons (32R and 32L) with their piston seals (33) and piston rods (34b). The pump is driven by one or two electric motors (M1 or M2) arranged between the two cylinder-piston units and equipped with spindle drives (40 and 42) for transmission, which convert the rotational movement of the motors into a reciprocating translational movement of the piston rods (34b).

[0109] In front of their pistons, each cylinder bore has a working space (VR and VL) with a connector for the drive fluid, through which the drive fluid flows in the same cycle through lines (18R and 18L) to the drive chambers of the two heart halves, squeezing blood from the blood chambers into the artery or aorta. The piston rod (34b) of the simple pump (31b) has two bearings and a ring-like element (35b) arranged between them, acting as a drive element. The drive element (35b) has on both sides coupling elements (36b) protruding from the pump case through an elongated hole, used for driving by a gearing driven by an electric motor, such as a spindle drive, a worm drive, a crank drive, an eccentric drive, a slider-crank mechanism, a rope, a belt and chain drive, or other known drive mechanisms. Furthermore, the ring-like element (35b) is provided on one side with a round pin (38) each as an arm, which preferably protrudes through an elongated hole from the pump case perpendicular to the piston rod between the two coupling elements (36b). The arms (38) are used as a fastener and guide for the manual coupling (39b) and, together with the coupling, are also used for manually actuating the piston rod (34b) after failure of the electric drive.

[0110] The coupling part (39b) comprises a handle with a round button at its end, which is located centrally between the two pistons and above the spindle nut (42) of the gearing. When the handle (39b) is pushed up or down, the movement of the piston rod (34a) disengages and reengages with the coupling element (46) of the gearing, with the tip of the coupling element (39b) sliding out and into the recesses (37b and 47) of the coupling elements (36b and 46). After the coupling part (39b) is disengaged, the patient can himself manipulate the artificial heart from side to side by manually moving the handle. This represents an improvement in cardiac massage and is safer than chest compressions, which include the risk of breaking ribs.

[0111] For added safety, each spindle (40) of the gearing is driven from both sides by two electric motors (M1 and M2) if there is a single gearing, or (M1 and M3) and (M2 and M4) in the case of two bearings rotating clockwise and counterclockwise. A one-way clutch coupling (48) between the electric motors and the spindle drives prevents sluggish or blocked spindle rotation in the event of electric motor failure.

[0112] FIG. 15 shows a check valve (17c) that is easy to manufacture and operates safely, used in medical technology as a heart or venous valve, or in other sectors such as wastewater technology or the chemical industry. The valve ring (26c) is arranged in a tubular hollow case (51) and acts as a step with at least a triangular or preferably hexagonal through-hole (i.e. bore). Each face of this bore forms a hollow geometric body with four triangular faces, like an asymmetric pyramid, one of these faces forming an isosceles triangle, as shown in top view d). Two faces are identical and have a common edge (52) on the central axis (D) of the case. The other two faces are hollow throughout, allowing the gas or liquid medium to flow through along the axis (D). By arranging a plurality of hollow bodies thus formed according to the number of faces of the polygonal bore around the axis (D), a pyramidal grid (54) is created in the tube piece (51) through which gas and liquid can pass from both sides. The triangular valve lamella is pivotally mounted on the side of the polygonal bore on the lattice structure, forming a very stable check valve for one flow direction. The rear side of the valve lamella is provided with a bulged rib (53), which on the one hand serves to stiffen the valve lamella against deflections and, on the other hand, serves to limit the valve opening by being placed in direct contact with the wall of the case (51).

[0113] FIG. 16 shows in a) a cross section through the mechanical connection (39a) between the two drive systems (40 and 42) and the cylinder-piston units (31 and 32) according to FIG. 11 perpendicular to the piston rod (34a) and in b) a cross section through the mechanical connection (39b) between the drive systems (40 and 42) and the two cylinder-piston units (32 and 34b) according to FIG. 14 perpendicular to the piston rod.

[0114] FIG. 17 shows the quick connection of the connectors (4, 5, 6) of the heart half shell with the veins and arteries. For the connectors, a positive bulge (55) is provided as shown in FIG. a). By placing one sleeve (15, 16 or 49) of the bag (12 or 13) on the connector and covering it with the vein, artery or hose, the quick connection (56) is placed around it and held in place by the barb (58) and locked by the sliding gate (59). The quick connection mechanism has a negatively formed recess (60) that matches the bulge (55) of the connector as shown in side view c). The sliding gate (59) has a two-part safety nose (61a and 61b) that prevents accidental opening.

[0115] Figure 18 shows a seamless blood bag (12) constructed from a synthetic or biological fabric or textile, preferably characterized by a three-dimensional ellipsoid shape, the size of which corresponds to a full half of a heart. An inlet and outlet (15 and 16) are provided, preferably cylindrical, and woven integrally with the blood bag.

[0116] In its upper half (12.1), the blood bag has a relatively thin structure together with the connections. After insertion into the rigid upper half-shell, this zone (12.1) remains almost immobile in its position in the wall of the rigid upper half-shell. The lower half (12.2) is thickened like a sickle or parabola, with a maximum thickness at the lowest point and a total parabolic decrease in thickness towards the midplane (E) of the bag. The thickening process is usually performed by applying a highly elastic material such as polycarbonate urethane (PCU) to the back side of the blood bag by a 3D printer, thus avoiding contact with the blood.

[0117] Figure 19 shows a seamless actuation bag (13), also made of synthetic or biological fabric or textile, the weaving process of which is also performed in such a way that it is integral with its connections (49), the shape of which is a three-dimensional ellipsoid, the size of which corresponds to a full half of the heart, preferably cylindrical, with connections (49) that serve as inlets and outlets.

[0118] In the zone of the lower half (13.1), i.e. below the central plane (E), the actuating bag has a thin woven structure, which remains almost immobile at the wall of the rigid lower half-shell. The upper half (13.2) is thickened in the shape of a sickle or parabola. The thickening starts entirely at the level of the central plane (E) and reaches a maximum value at the upper point. The parabolic thickening of at least one of the mobile halves of the two bags ensures that the bending wave (63), i.e. the deformation wave, of said bag starts explicitly from the center, i.e. from the plane (E), and is reproduced entirely along the wall of the rigid half-shell up to the upper and lower apex, respectively.

[0119] A drive bag designed in this way moves independent of its position and direction of motion, so that the end or tip of the bag is always the last part to be inverted, since the thickness and resistance to bending at this location is greatest.

[0120] When the two half shells of the heart half are inserted together, the lower half of the blood bag (12.2.) is placed loosely on the upper half of the drive bag (13.2). These two bag halves are preferably placed on top of each other with a gel-like substance such as paraffin between them, which allows them to move or float between the two liquids in question (blood on the one hand and drive fluid on the other) but without forming wrinkles and kinks back and forth or up and down depending on the position of the body and with low stresses. Since the two bags are placed on top of each other, it is usually necessary to thicken only one of them parabolically.

[0121] Figure 20 shows a blood bag with annular elliptical teeth on the lower half (12.2). The shape of the teeth (61) is preferably circular, but other shapes such as involutes or cycloids, or other designs commonly used in gear tooth formations are also possible. The thickness increases as the distance of the ring to the central plane (E) increases.

[0122] Figure 21 shows a drive bag whose upper half (13.2) has annular elliptical teeth all the way around. The dovetails (62) of the drive bag are offset by one tooth each with respect to the dovetails of the blood bag. When both bags are placed on top of each other, the teeth of one bag always fit into the gaps between the teeth of the other bag.

[0123] FIG. 21c shows the profile of the elliptical annular gear (62) of the drive bag (13) in two positions (62a and 62e). The profile (62a) visualizes the state of the annular gear when the drive bag is completely empty and its upper half (13.2) is located inside the lower half (13.1) (see 13a in fig. 28 and 29). On the other hand, the profile (62e) shows the state of the annular gear when the drive bag is completely filled, as shown in FIG. (21b) (see 13e in fig. 28 and 29). The material of the two bags cannot be stretched, but the dovetail is made of elastic material. When the annular gear is rotated around the central axis of the ellipse of its profile, the resistance to twisting in the different positions is not the same. For this reason, the annular gear remains in its position until it reaches the wall of the opposite rigid shell, as long as the bag is suspended between the liquids while it moves from one half of the rigid shell to the other. As soon as the outermost point of each ring gear reaches the rigid shell, the driving medium pushes or pulls the zone located inside the ring gear, causing the ring gear to rotate from one stable position to the second stable position. The thickest ring gear is the last element to be reversed during each movement, since it offers the greatest resistance to twisting.

[0124] Combinations of thickening and / or dovetailing of blood and / or drive bags are always possible.

[0125] Figure 22 shows the complete artificial heart, composed of two halves (IR and IL). Each heart half features a rigid shell composed of two half-shells (2 and 3) that are plugged together and clamped airtight. Each half-shell contains a bag (12 and 13), the volume of which corresponds to half the volume of the complete heart. The upper half of the blood bag (12) is located in the upper half-shell and is more or less immobile. Its lower half is parabolically thickened and is freely movable.

[0126] Half of the drive bag (13) is located within the lower half-shell and is substantially stationary. In this view, half of the drive bag (13) is not thickened.

[0127] One half of these bags is relatively immobile and sits inside a rigid half-shell, while the second half is placed back-to-back and moves together as shown here from position a (both blood bags are full), across b, c, and d, to e (at this position both heart halves are completely empty). Both heart halves function in sync, just like a real heart. This phase corresponds to systole.

[0128] Figure 23 shows the synchronous movement during diastole of the two moving halves of the two bags of the artificial heart shown in Figure 22 from position e (= empty) across positions f, g and h to position a (= full). The different wall thickness of one of the two bags causes both bags to bend when moving along the wall of the rigid shell in one or the other direction from the mid-plane (E), thus ensuring a complete and layered emptying of the blood bags.

[0129] Figure 24 shows the whole artificial heart consisting of two halves (IR and IL) with the toothed blood bag (12) and the toothed drive bag (13) in systole. Both heart halves work synchronously. Regarding the movement of the bag halves, the effect of the dovetail on the backside of the two bags is identical to the effect of the thickening of the halves. The dovetail of the bag corresponds to a partial or irregular thickening. For this reason, the outer envelope of the thickened bag can also be considered as a wavy model. This method corresponds to a combination of thickening and dovetailing.

[0130] Figure 25 shows the artificial heart shown in Figure 24, this time in diastole. Both heart halves draw blood from the body periphery and the lungs.

[0131] Figure 26 shows an asynchronously beating artificial heart with a thickened blood bag (12) according to the invention. The right half of the heart draws blood from the body, while the left half pushes it into the aorta.

[0132] Fig. 27 shows the asynchronously beating artificial heart shown in Fig. 26, now in the opposite phase. The right half of the heart pumps blood into the pulmonary artery, while the left half simultaneously sucks oxygen-rich blood from the lungs. Theoretically, the amount of blood pumped through the lungs during each heartbeat by a heart beating asynchronously in this way exceeds the amount pumped by a real heart, since the real heart during the diastolic phase cannot suck blood as a forced induction pump would. An artificial heart beating in this way even causes a negative pulsation of the larger veins by a suction effect.

[0133] FIG. 28 shows a heart beating asynchronously as in FIG. 26, but with dovetailed blood and drive bags.

[0134] FIG. 29 shows a heart beating asynchronously as in FIG. 27, but with dovetailed blood and drive bags.

[0135] FIG. 30 shows a double piston pump unit consisting of a two-piece case (31cL and 31cR) and a piston rod (34c) with pistons (32bR and 32bL) on both sides without sealing. The piston rod (34c) is provided with a drive element (or ring-shaped element) (35) with a connecting element (36) and a recess (37) in the middle between the two pistons. Two separate working chambers (VR1 and VL1, and VR2 and VL2) are provided in front of and behind each of the two pistons. The right (VR1 and VR2) and left (VL1 and VL2) working chambers are connected to each other and to one of the drive bags by hoses (18R and 18L), respectively. Each piston is provided with two relief valves consisting of a through hole (64), a retaining ball (65), a pressure spring (66) and a cannulated adjustment screw (67). The volume of each working chamber is larger than the required volume of drive medium so that with each stroke an overrun flows from one piston side to the other, through the relief valve and over the pistons.

[0136] Pumps designed in this way can function without piston seals because the drive fluid that flows from one side of the piston to the other returns along the same path, either along the piston or through the relief valve, when the piston moves in the opposite direction.

[0137] This configuration represents a self-contained hydraulic system which notably increases the safety and service life of the artificial heart, and reduces piston friction and energy consumption.

[0138] The features detailed in this specification, in the drawings and in the claims, may be relevant for the realization of the invention both individually and in any combination. [Explanation of symbols]

[0139] 1 Half Heart 2 Upper half shell 3 Lower half shell 4 Blood inlet opening 5 Blood outlet opening 6 Inlet and outlet of driving medium 7 Lubricant inlet and outlet 8 Lower edge of upper half shell 9 Edge of lower half shell 10 Seal ring, O-ring 11a Half Shell Positive Fastener 11b Half Shell Negative Fasteners 12 Blood chambers and blood bags 13 Drive compartment and drive bag 14 Gap between blood bag and drive bag 15 Sleeve = Blood bag inlet 16 Sleeve = Blood bag outlet 17 Prosthetic valves (three versions a, b, and c) 18 Drive medium lines or hoses 19 Lubricant lines or hoses 20 Lubricant bore or connector 21 Small camera storage bore 22 Pressure sensor housing bore 23 Ring-shaped gap at the equator between two half shells 23a Longitudinal grooves in half shell 23b Ring-shaped transverse grooves in the half shells 24 rigid valve lamellas (3 versions - a, b and c) 25 Swivel joint between valve lamella and valve ring 26 Valve Rings (3 versions - a, b and c) 27 Swivel joint between valve lamella and side lamella 28 Lateral lamina 29 Swivel joint between two adjacent side lamellas 30 Bow spring element, elastic shackle 31 Cylinder piston unit case 32 Piston of cylinder piston unit 33 Piston seal 34 Piston rod (2 versions a and b) 35 Round plate as driving element for piston rod 36 Piston rod joint or joint element 37 Recess in coupling element 36 38 Pin as arm or lever 39 Manual coupling with handle or knob 40 Spindle, spindle drum 41 Spiral groove on spindle drum 42 Sleeve as spindle nut 43 Shuttle as a sliding block 44 Bearing pin 45 Axis of radial bore in sleeve wall 46 Projecting part of spindle nut (sleeve) as a connecting element 47 46 recess 48 Connection with one-way clutch 49 Sleeve = Drive bag connection 50 Convex lenticular pad filled with viscous material 51 Ring-shaped hollow case, tube piece 52 Common Edges of Hollow and Triangular Asymmetric Pyramids 53 Bulge as a reinforcing rib and to limit the opening of the valve thin plate 24c 54 Pyramidal lattice structure 55 Bulging of the connector of the heart half 56 Veins or Arteries 57 Arched plastic tape as a quick release 58 Return 59 Slide Gate with Safety Nose 60 negatively arched surface = concavity 61 Parallel lines of a ring-shaped thickened or dovetailed blood bag with tensile stiffness 62 Tension-stiff, ring-shaped thickened or dovetail-shaped drive bag parallel lines 63 Bending waves, i.e. deformation waves 64 Piston Hole 65 Valve ball of pressure limiting valve (relief valve) 66 Relief valve spring 67 Relief valve screw A. Longitudinal axis of the heart half B: Bending axis of the elastic connection between the two heart halves C. Midplane between the two cardiac halves D Valve case shaft E. A plane perpendicular to the longitudinal axis (A) passing through the equator of the heart hemisphere. F Plane passing through the drum A plane passing through the drum perpendicular to the GF H A plane perpendicular to plane C along the center of the artificial heart V Total volume of the heart = Maximum cardiac output n Number of valve ring faces = Number of valve lamellae (main blades of the heart valve)

Claims

1. A half of an artificial heart, comprising a hermetically sealed hard shell as a housing of the half of the artificial heart, the half of the artificial heart having a blood chamber including an inlet and an outlet, and a drive chamber including a connection for the inlet and the outlet; The hard shell is divided into at least a first half shell and a second half shell, the first half shell includes an inlet opening and an outlet opening; the second half shell includes an opening and means for receiving a drive medium; The blood chamber is composed of one blood bag, The drive chamber is composed of one drive bag, a first portion of the blood bag up to a first half of the blood bag is attached to at least a portion of the first half shell; a first portion of the actuation bag up to a first half of the actuation bag is attached to at least a portion of the second half shell; a second portion of the actuation bag to a second half of the blood bag in contact with a second portion of the actuation bag to a second half of the blood bag; as the portion of the second half of the actuation bag moves, the interface between the actuation bag and the blood bag creates an axisymmetric bending wave along the second portion of the blood bag; An artificial heart half, wherein the second portion of the blood bag moves alternately within the hollow portion of the first half-shell and within the hollow portion of the second half-shell under stress and stretch relief.

2. 10. The artificial heart half of claim 1, wherein at least one portion of said blood bag and said actuation bag are woven from biological yarn.

3. 2. The artificial heart half of claim 1, further comprising an elastic pad disposed between said second portion of said blood bag and said second portion of said drive bag.

4. 4. The artificial heart half of claim 3, wherein said elastic pad is a lenticular convex elastic pad.

5. 2. The artificial heart half of claim 1, wherein at least one of the blood bag second portion and the drive bag second portion has an axisymmetric three-dimensional shape and is thickened in a parabolic arc.

6. 2. The artificial heart half of claim 1, wherein the rear surface of the second portion of the blood bag has an axially symmetrical, latitudinal tooth-like bulge, and the rear surface of the second portion of the drive bag has an axially symmetrical, latitudinal tooth-like bulge.

7. 7. An artificial heart half according to claim 6, characterized in that the tooth-like bulges are produced by accumulation of material or by the insertion or incorporation of rigid rings, in particular interdigitated like chain links.

8. 2. The artificial heart half of claim 1, wherein the driving medium is a liquid.

9. 2. The artificial heart half of claim 1, wherein the geometric shape of said rigid shell is that of a two-dimensional or three-dimensional ellipsoid.

10. 2. The artificial heart half of claim 1, wherein the first half-shell and the second half-shell are connected by positive and negative interlocking connections with axisymmetric conical connecting surfaces.

11. 10. The heart prosthesis of claim 1, wherein the rigid shell further comprises longitudinal and lateral grooves on an inner surface of the rigid shell.

12. 2. The artificial heart half of claim 1, wherein said rigid shell further comprises a third chamber between said blood bag and said drive bag having an external connection for containing a viscous lubricating and sealing agent.

13. 13. The artificial heart half of claim 12, wherein said third chamber includes means for regulating cardiac output.

14. 2. The half of the artificial heart according to claim 1, wherein the rigid shell has one positive cylindrical connecting element and one negative cylindrical connecting element adjacent to each other on one side thereof, designed so that the rigid shell can be connected to a second rigid shell comprising the second half of the artificial heart by rotating the rigid shell 180° about its longitudinal axis (C), and the combination of the rigid shell comprising the half of the artificial heart and the second rigid shell comprising the second half of the artificial heart forms a complete artificial heart.

15. 2. The artificial heart half of claim 1, wherein the axisymmetric bending waves occur along an inner surface of the rigid shell.

16. 2. The artificial heart half of claim 1, wherein stresses, stretches and folding associated with movement of the second portion of the blood bag into the hollow portion of the first half-shell and into the hollow portion of the second half-shell are eliminated.

17. further comprising an electric hydraulic pump unit; The electric hydraulic pump unit includes: A cylinder-double piston unit including two pistons, a common piston rod disposed between the two pistons, and at least one working space per piston (VR&VL), wherein the cylinder-double piston unit, the two pistons, the common piston rod, and at least one working space per piston are disposed in a cylindrical case; a piston rod drive element attached to the common piston rod; at least one coupling element, a portion of the coupling element being attached to the drive element and a second portion of the coupling element extending outside the cylindrical case; at least one drive mechanism disposed outside the cylindrical case and connected to the drive element via a portion of the coupling element that extends outside the cylindrical case; and 2. The artificial heart half of claim 1, wherein the cylinder-double piston unit includes a connector for a driving fluid.

18. each of the at least one drive mechanism of the electro-hydraulic pump unit is actuated by at least one electric motor disposed at at least one end of the drive mechanism; a one-way clutch attached to each of the at least one electric motor; a cylindrical body attached to the one-way clutch; The surface of the cylindrical body is provided with two grooves in opposite directions, extending tangentially inwardly towards each other in a right and left helical configuration in a double start configuration; 18. The artificial heart half of claim 17, wherein said cylindrical body drives a means for driving said common piston rod, said drive element being a ring-shaped drive element.

19. 18. The artificial heart half of claim 17, further comprising a manually actuated coupling element for engaging and disengaging said drive element with said drive element of said common piston rod to allow manual propulsion of a drive medium into said artificial heart.

20. 18. The artificial heart half of claim 17, wherein the drive mechanism gearing is actuated by one of a spindle drive, a worm drive, a crank drive, an eccentric drive, a slider-crank mechanism, a rope, a belt, and a change drive or other known drive mechanisms.

21. 18. The artificial heart half of claim 17, further comprising two separate working chambers in front of and behind each of said pistons.

22. 22. The artificial heart half of claim 21, further comprising a hose connecting the working space for a first of the two pistons with the working space for a second of the two pistons.

23. 22. The artificial heart half of claim 21, further comprising at least one relief valve for each of said two pistons.

24. 24. The artificial heart half of claim 23, wherein each of said relief valves includes a through hole, a retaining ball, a pressure spring, and a cannulated adjustment screw.

25. 22. The artificial heart half of claim 21, wherein the volume of the working space for each of the two pistons is greater than the volume of the rigid shell.

26. 24. The artificial heart half of claim 23, wherein the drive medium is transferred from one piston side to the other piston side via the relief valve.

27. 26. The artificial heart half of claim 25, wherein a drive medium is conveyed on each of said pistons.

28. The electrohydraulic pump unit includes a spindle drive consisting of a spindle screw and a spindle nut, the spindle screw including a (double) left and right endless loop in the form of a helical groove; 18. The artificial heart half according to claim 17, wherein the spindle nut consists of a hollow cylinder without threads, such as a piece of tube, and in the spindle there is provided at least one sliding block in the form of a three-dimensionally curved and rounded shuttle which slides smoothly and without jerks in the groove of the spindle thread.

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