DE102020132268B3 - ARTIFICIAL HEART - Google Patents

Abstract

An artificial heart contains a heart sac (10), a paddle unit (7), a drive unit (28) and a control unit. The artificial heart preferably contains a cardiac skeleton ring (37), an adaptation framework (56), an artificial heart base (83) and an angle adjustment system (1). The skeletal ring (37) is designed true to anatomy and, like the cardiac sac (10), contains at least one entry opening and at least one exit opening. The adaptation framework (56) is anatomically manipulated so that it promotes blood circulation into the heart sac (10) and partially prevents it in at least two openings. The drive unit (28) is mounted on an artificial heart base (83) and causes at least one paddle (53) of the paddle unit (7) to rotate in order to generate a pumping movement. The control unit controls the required angle and/or the required angular velocity of the at least one paddle (53) of the paddle unit (7) in such a way that a volume limited by the cardiac sac (10) is continuously variable due to the rotational movement. The angular adjustment system (1) attaches the above components of the artificial heart to a spine. This angle adjustment system supports the remaining tissue of the natural heart in distributing the weight, while still guaranteeing the relatively free movement of the artificial heart.

Description

The invention relates to an artificial heart that can be implanted in a human or animal body.

The number of advanced heart failure patients worldwide who need a new heart is constantly increasing. With the increasing need for donor hearts, the waiting time for a life-saving heart transplant is also increasing. Furthermore, there is a group of patients in whom a very poor pumping function of the heart occurs due to an intraoperative or postoperative complication. These patients actually did not need a new heart.

In order to be able to alleviate the increasing need for acute heart transplants, there are, for example, "left venticular assist devices" (German: "left heart chamber support device") LVAD. These devices essentially consist of an implanted pump head containing an axial pump and an extracorporeal control unit. The pump head is attached to the apex and ascending aorta of a natural heart by means of a vascular prosthesis. This so-called outflow prosthesis pumps the blood sucked out of the heart via the apex of the heart into the ascending aorta. A centrifugal pump or axial pump constantly sucks out the blood and thus supports the left ventricle. The extracorporeal control unit is connected to the implanted pump head via a line.

Such an LVAD is disadvantageous since it poses a significantly increased risk of infection for the patient due to the connecting line penetrating the skin. A particular disadvantage of this device is that the LVAD is only designed for the treatment of a weakened pumping function of the left ventricle. In the treatment of combined right/left heart failure, there is even a particularly disadvantageous contraindication for the use of an LVAD. In an LVAD, the wearer's blood is in constant contact with the metal rotating components of the pump, causing a propensity for thrombus formation or hemolysis. To prevent thrombus formation or haemolysis, it is essential that the patient takes strong blood thinners. The LVAD creates continuous pressure in the bloodstream. This continuous pressure favors the formation of an arterial, venous malformation (arteriovenous malformation). These malformations often result in internal bleeding, which can be life-threatening if the necessary blood thinning medication is taken. Furthermore, the LVAD can cause malignant ventricular arrhythmias in 20-50% of implanted cases. These devices are intended as a bridging measure until a transplant or possibly as a definitive therapy. However, the quality of life is massively restricted by a LAVD.

US 2014/0 371 849 A1 shows a self-contained, fully implantable blood pump. It is a small spherical device that encompasses all of the blood transport dynamics, with the device being divided into two hemispheres. A first and a second membrane separate the interior of each hemisphere into a chamber. Each hemisphere has an inlet valve and an outlet valve in the form of artificial heart valves. A rotating core is attached to a shaft inside the artificial heart, which in turn is coupled to a motor to spin the core.

the U.S. 4,600,405A shows an artificial heart consisting of an artificial heart housing with a multiplicity of chambers arranged therein. A vibrating vane is located in the housing for expelling or drawing in the blood in each chamber formed in the artificial heart housing. The oscillating wing is driven electromechanically from the outside of the housing. A variety of inlets and outlets allow blood to be pumped to and from different parts of the body.

the U.S. 4,310,930A shows an artificial heart pump with a vane arranged in the interior of a blood pump chamber. The vane is mounted on a vane shaft that extends from the gear housing into the blood pumping chamber. Check valves are provided to control the direction of blood flow and determine the mode of operation of the pump.

the DE 10 2011 054 768 A1 shows an artificial heart to replicate a human heart. This artificial heart consists of two crescent-shaped pumping chambers, each with an inlet opening and an outlet opening, a drive device and an energy store. Each pumping chamber is delimited by a flexible and a rigid wall. A pumping function of the artificial heart is achieved by deforming the flexible wall with the help of the drive device. For this purpose, the drive device is arranged between the conveying chambers. In order to achieve a directed blood flow, a non-return valve is integrated into the inlet opening and the outlet opening of each pumping chamber.

Disadvantage of the in the DE 10 2011 054 768 A1 shown artificial heart is the crescent shape of the pumping chambers with a star wall. Due to the sickle shape in connection with the rigid wall, a complete exchange of the blood in the heart is not guaranteed. In addition, the flap system used is disadvantageous, since such a flap system promotes the formation of turbulence. To counteract the adverse effect, the patient is given anticoagulant medication. Constant medication with such agents is risky for the patient and is therefore particularly disadvantageous. Another disadvantage of this artificial heart is its own weight, which puts extreme strain on the thin vein walls during physical activity.

The invention is therefore based on the object of creating a permanently implantable artificial heart that makes it possible to dispense with anticoagulant measures. In addition, the artificial heart should be reliable and improve the patient's quality of life.

The problem is solved by an artificial heart with the features of the main claim. Advantageous further developments are the subject matter of the subclaims which refer back thereto.

An artificial heart according to the invention contains a heart sac, a paddle unit, a drive unit and a control unit. The heart sac contains at least one entry port and at least one exit port. The drive unit is designed in such a way that it causes at least one paddle of the paddle unit to rotate. The angle and/or angular speed of the at least one paddle of the paddle unit are controlled by the control unit.

The paddle unit is preferably designed in such a way that a volume delimited by the cardiac sac is continuously variable over the rotational movement.

Advantageously, the combination of heart sac and paddle unit ensures constant movement of the blood flowing into and out of the heart sac. Thus, a trom formation in the blood volume located in the artificial heart is prevented. By controlling the angle and/or angular velocity of the at least one paddle of the paddle unit, almost any desired type of pulsating blood flow in the form of a physiological, pulsating pump action in both the pulmonary and systemic circulation can be simulated in a particularly advantageous manner. The formation of arterial and/or venous malformations is particularly advantageously avoided by the physiological pulsating pumping action. Advantageously, by replacing weakened heart chamber muscles with a mechanical system, ventricular (originating from the heart chambers) cardiac arrhythmias are avoided.

In addition, the paddle unit of the artificial heart according to the invention contains at least one slider. This slide is linked to the rotary movement of the paddle unit. The slide is designed in such a way that the at least one entry opening of the heart sac can be closed by this slide.

In a particularly advantageous manner, the slide ensures that the blood in the cardiac sac is largely prevented from flowing back through the inlet opening. In addition, the design of the backflow prevention in the form of a slide makes it possible to dispense with the administration of blood thinners.

The cardiac sac of the artificial heart also consists of two chambers. Between the two chambers of the heart sac, first and second planar surfaces are formed on each of the chambers. A septum is fitted between the first flat surfaces. The paddle assembly is positioned between the second planar surfaces of the cardiac sac.

The division of the heart sac into two advantageously enables a separate blood flow to be simulated for the large and small blood circuits. The septum in the area of the first flat surfaces of the heart sac prevents a transfer of pumping movements between the chambers of the heart sac and maximizes the impact effect generated by the paddle and thus the heart stroke volume. The placement of the paddle assembly between the second planar surfaces of the cardiac sac allows compression of the cardiac sac.

The drive unit of the artificial heart preferably contains a gear which contains at least two partially toothed gear wheels. The partially toothed gear wheels are designed in such a way that at least two paddles of the paddle unit are coupled by the gear and are moved with a time delay.

Advantageously, a time-delayed actuation of the paddles is achieved by the coupling of two paddles via the partially toothed gears in the transmission. This results in a pulsating blood flow that approximates the human heartbeat. The difference in time between the small and large blood circulation is also particularly advantageously understood.

The drive unit of the artificial heart comprises at least one servomotor which has a sensor system for detecting the angle of a paddle holds. The servomotor with its sensors advantageously enables the precise setting of a paddle angle and precise compliance with the setting speed.

Preferably, the artificial heart includes a heart cover and a skeletal ring. The heart sac, the paddle assembly, the control unit and the drive unit are preferably enclosed within the heart cover. The skeletal ring closes off the heart cover at least in the area of the at least one entry opening and at least one exit opening of the heart sac.

The heart cover in conjunction with the skeletal ring advantageously prevents tissue intrusion into the mechanics of the artificial heart. In addition, damage to the surrounding tissue by the moving parts of the artificial heart is prevented. Furthermore, accidental or doctor-caused (iatrogenic) damage to the inner components of the artificial heart is prevented.

The artificial heart preferably comprises a cuff and an angle adjustment system. The cuff partially encloses the heart cover and allows the artificial heart to be fixed using the angle adjustment system.

Advantageously, the artificial heart is fixed in the human body by the angular adjustment system, which is attached to the heart cover by means of the cuff. The angle adjustment system simulates the mobility of the natural human or animal pericardium with regard to its position in the body. The angle adjustment system absorbs the weight of the heart without restricting the relatively free movement of the heart in different postures. The weight force is transferred to the patient's bony structures. The angle and the position of the artificial heart can be adapted to the anatomical specifications of the body in a particularly advantageous manner.

The control unit contained in the artificial heart preferably comprises a microcontroller, a communication unit and a motor interface. The microcontroller is configured in such a way that the artificial heart generates an artificial heartbeat. To do this, the control unit controls the servo motor using the motor interface. The motor interface is also used to record the angles determined by the servo motor sensors. The communication unit provides a contactless data connection for the transmission of default values and/or measured values.

The control unit advantageously controls the heartbeat generated by the artificial heart. The pump output can be adjusted particularly precisely with the help of the angle data recorded via the motor interface. The behavior of the heartbeat can be precisely adapted to the needs of the patient and his body via the communication interface. For this purpose, parameters and measured values can advantageously be called up and set from the controller via the communication interface. Haemodynamic measurements, such as velocities and stroke volumes, can be read out via the valve openings in a particularly advantageous manner. Control via the contactless data connection enables not only the doctor, but also the patient himself to have spatially unlimited and therefore particularly user-friendly control over the artificial heart. Advantageously, the artificial heart can be synchronized with the remaining intact sinus impulses by means of an electrode implanted in the rest of the septum and thus stubborn supraventricular arrhythmias can be terminated.

The artificial heart according to the invention preferably contains an energy store that can be charged without contact. Advantageously, the artificial heart can be supplied with energy by the contactless chargeable energy store without causing a risk of infection by charging connections penetrating through the skin surface.

The heart sac of the artificial heart is preferably made of a hypoallergenic polysiloxane with a Shore A hardness of 10 Shore to 20 Shore or a polyester. Advantageously, no blood adheres to such a hypoallergenic polysiloxane. Material-related thrombus formation can thus be prevented. In addition, such a material is extremely tear-resistant and extremely stretchable.

The artificial heart preferably contains an adaptation framework with at least one opening. The ports are designed to connect the at least one entry port and at least one exit port of the heart sac to at least one corresponding connector sleeve of the skeletal ring.

Advantageously, one and the same basic construction of the artificial heart can be used in almost every patient. In a particularly advantageous manner, the artificial heart can be adapted to the physiological conditions via the adaptation framework in connection with the skeletal ring.

• 1 eine 3D Innenansicht eines Ausführungsbeispiels des künstlichen Herzens;
• 2 eine 3D Innenansicht des Herzsacks eines Ausführungsbeispiels mit den Schiebern;
• 3 ein Winkelverstellsystem eines Ausführungsbeispiels;
• 4 eine Implantationsstelle eines Ausführungsbeispiels;
• 5 einen Skelettring eines Ausführungsbeispiels;
• 6 einen Umfangsring eines Ausführungsbeispiels mit dem Konnektor;
• 7 einen Herzsack eines Ausführungsbeispiels;
• 8 eine künstliche Herzbasis eines Ausführungsbeispiels;
• 9 ein Adaptionsgerüst eines Ausführungsbeispiels;
• 10 ein Septum eines Ausführungsbeispiels;
• 11 eine Paddeleinheit eines Ausführungsbeispiels;
• 12 eine Zusammenstellung des Herzsacks eines Ausführungsbeispiels mit der künstlichen Herzbasis;
• 13 eine Abdeckung für den Herzsack eines Ausführungsbeispiels mit der Zusammenstellung;
• 14 ein Getriebe eines Ausführungsbeispiels mit den Zahnrädern;
• 15 eine Herzabdeckung eines Ausführungsbeispiels, der Servomotor, und derer Komponenten;
• 16 A-C Zahnräder eines Ausführungsbeispiels und derer Mechanik;
• 17 A-B ein Ausführungsbeispiel des gesamten künstlichen Herzens;
• 18 ein Verfahren zur Montage des künstlichen Herzens;
• 19 ein Verfahren zur Vorbereitung einer von einer Herzabdeckung umschlossenen Einheit; und
• 20 ein zweites Ausführungsbeispiel mit einer Dichtscheibe.

Exemplary embodiments of the invention are described below with reference to the drawing. The drawings show:

• 1 a 3D interior view of an embodiment of the artificial heart;
• 2 a 3D interior view of the heart sac of an embodiment with the sliders;
• 3 an angle adjustment system of an embodiment;
• 4 an implantation site of an embodiment;
• 5 a skeletal ring of one embodiment;
• 6 a peripheral ring of an embodiment having the connector;
• 7 a cardiac sac of one embodiment;
• 8th an artificial heart base of one embodiment;
• 9 an adaptation framework of an embodiment;
• 10 a septum of one embodiment;
• 11 a paddle unit of one embodiment;
• 12 an assembly of the cardiac sac of an embodiment with the artificial heart base;
• 13 a cardiac sac cover of an embodiment comprising the assembly;
• 14 a transmission of an embodiment with the gears;
• 15 a heart cover of one embodiment, the servomotor, and their components;
• 16AC Gears of an embodiment and their mechanics;
• 17 AB an embodiment of the entire artificial heart;
• 18 a method of assembling the artificial heart;
• 19 a method of preparing a cardiac cover enclosed assembly; and
• 20 a second embodiment with a sealing washer.

1 and 2 show a three-dimensional representation of the internal and some external components of an embodiment of the invention. The artificial heart according to the invention contains an angle adjustment system 1. A distal cuff 2 is attached to the angle adjustment system 1 via a ball joint 134. This distal cuff 2 serves as a mount for the artificial heart. The artificial heart further includes a servo motor 3. A motor cover 4 is located over the servo motor 3. To the servo motor 3 a first gear 5 is connected. This first gear 5 and a second gear 6 form a gear 138 for transmitting the rotational movement of the servo motor 3 to the paddle units 7.

Other components of the artificial heart are a left chamber 8 and a right chamber 9, which are part of an artificial heart sac (not shown in full here). A septum 11 is located between the left chamber 8 and the right chamber 9. All components are described in detail below.

3 shows a proximal angle adjustment system 1. This angle adjustment system 1 consists of a base 12, an adjustment arm 13 and an angle joint 14. The base 12 of the angle adjustment system 1 is as shown in FIG 3 to be recognized as an angle. The short leg of the base 12 ends in the angle joint 14 and is used to attach the adjustment arm 13.

The long leg of the base 12 is trough-shaped. The base surface is concave for better adaptation to anatomical conditions. In the tub base is a transverse toothing 15 and a longitudinal slot 16, which extend almost over the entire length of the long leg of the base 12, is provided. The elongated hole 16 is used to carry out fastening screws. With the help of the slot 16, an exact positioning of the angle adjustment system 1 is possible even with a variable hole spacing of the attachment points. In the long leg of the base 12 designed as a trough, two displaceable nuts 17 are mounted. The slidable nuts 17 are provided with teeth which are designed to match the transverse teeth 15 of the base 12 . The toothing achieves a form fit when the fastening screws are tightened, so that there is sufficient resistance to displacement even with low tightening torques of the fastening screws.

The angle joint 14, which is attached to the short leg of the base 12 of the angle adjustment system 1, includes an angle joint housing 18 which is an integral part of the short leg of the base 12. On the angle joint housing 18, a first toothed disc 19 is inserted and fixed with a central bore. From the side of the housing 18 facing the inside of the base 12, a second toothed disc 20 containing a toothed disc axis 21 is inserted. This second toothed disc 20 is designed to be movable in the angle joint housing 18 . The serrations of the first serrated disc 19 and the second serrated disc 20 are shaped to positively engage each other when compressed.

In addition, a spring 22 is inserted into the angle joint housing 18, which presses the first toothed disk 19 against the second toothed disk 20 with a defined force. The angle joint housing 18 is closed with a cover 23 in such a way that the spring 22 is prestressed. In the exemplary embodiment, the toothed disc axis 21 protruding from the angle joint housing 18 is provided with a square flange 24 at its end. The square flange 24 is used to hold the adjustment arm 13 in a torsion-proof manner.

The adjustment arm 13 includes at its first end a bore for receiving an angle joint fastening screw 25. This bore is further equipped with a square which is designed to receive the square flange 24 of the toothed disc axle 21 protruding from the angle joint housing 18. At its second end, the adjustment arm 13 contains a rack and pinion drive 26. This rack and pinion drive 26 consists of a gear of the rack and pinion drive 27 with a gear wheel axis 28 and a securing element 29. The gear wheel axis 28 of the gear of the rack and pinion drive 27 contains a triangular recess 30 for turning.

By rotating the gear wheel of the rack and pinion drive 27, a rack 31, not shown here, is moved in or out. Once the desired position has been reached, the toothed rack 31 (not shown here) can be locked by axially pushing in the securing element 29 . At the same time, the gearwheel of the rack and pinion drive 27 is shifted axially in such a way that it no longer engages in the rack 31 (not shown here). To release the lock, the axially displaced gear wheel of the rack and pinion drive 27 is pressed into its starting position and the securing element 29 is thus likewise pushed into its basic position. In this way, the securing element 29 is released from the toothed rack 31 (not shown here) and enables its movement again.

the 4 shows a section through the human heart in a plane that corresponds to an implantation plane 32 for the artificial heart. The implant plane 32 is the area of the human heart where the heart chambers of the natural heart are severed. The implantation level 32 shown shows an opening to the left atrium 33, an opening to the aorta 34, an opening to the right atrium 35 and an opening to the pulmonary trunk 36.

5 12 shows a skeletal ring 37. The skeletal ring 37 is the interface of the artificial heart to the relevant cardiac structures. It is connected to the remaining structure of the natural heart in the area of the implantation level 32 . The skeletal ring 37 is provided with a left atrial connector sleeve 38 , an aortic inlet connector sleeve 39 , a right atrial connector sleeve 40 and a pulmonary trunk connector sleeve 41 .

The connecting sleeves are tubular structures molded perpendicular to the plane of assembly of the skeletal ring 37 . A termination sleeve 42 encloses the connecting sleeves mentioned above. The end sleeve 42 is also formed perpendicularly to the mounting plane of the skeleton ring 37 . The skeleton ring 37 also includes skeleton ring mounting holes 43 supported with metal rings. The skeletal ring 37 consists of plastic, preferably a polytetrafluoroethylene PTFE or a collagen-coated polyester. Other physiologically suitable materials can also be used.

6 shows a peripheral ring 44 and a connector 45. The peripheral ring 44 is an elliptical disc with an inner recess 46. The outer contour of the peripheral ring 44 corresponds to the outer contour of the skeletal ring 37. The inner recess corresponds to the shape of the end sleeve 42 of the skeletal ring 37. To carry out Circumferential ring mounting holes 47 are provided for fasteners. The peripheral ring 44 is made of metal, preferably made of medical grade stainless steel. Alternatively, it can also be made of PTFE in conjunction with a carbon fiber reinforced plastic.

The connector 45 consists of a cylindrical tube. The opening of the tube facing the remaining natural heart is widened axially towards the middle of the tube. This ensures that the peripheral ring 44 and the skeleton ring are also partially covered in the radial area. Bulges are provided in the connector 48 in the area of the connecting elements, which are designed in such a way that the connecting elements can be accommodated therein without deforming the connector 47 . The end of the tube facing the artificial heart is also widened axially towards the middle of the tube. The connector 47 is sized to encompass the peripheral ring 44 and the skeletal ring 37 peripherally. The connector 47 consists of a robust but relatively elastic plastic. Thus, the peripheral ring 44 and the skeletal ring 37 are held together as a unit.

7 12 shows the cardiac sac 10 of the embodiment of the artificial heart. In this example, it contains a left chamber 8 and a right chamber 9. They represent the so-called "inferior parts" that replace the two ventricles. The cross-section of each of the two chambers is almost semi-circular in shape, as can be clearly seen in section BB. Each of the two chambers 8, 9 is designed in the form of a quartered ellipsoid viewed perpendicularly to the section plane BB. The left chamber 8 is closed towards the middle by a first flat surface 49 of the left chamber 8 and a second flat surface 50 of the left chamber 8 .

The right chamber 9 has a mirror-symmetrical design. The right chamber 9 is closed off by a first flat surface 51 of the right chamber 9 and a second flat surface 52 of the right chamber 9 . The distance between the first flat surface 49 of the left chamber 8 and the first flat surface 52 of the right chamber 9 is smaller than the distance between the second flat surface 50 of the left chamber 8 and the second flat surface 52 of the right chamber 9. The Distance between the first flat surface 49 of the left ventricle 8 and the first flat surface 51 of the right ventricle 9 is designed so that the septum 11 can be accommodated therebetween. The distance between the second flat surface 50 of the left chamber 8 and the second flat surface 52 of the right chamber 9 is designed in such a way that the paddle unit 7 can be accommodated therein.

The curved outer surfaces of the left chamber 8 and the right chamber 9 have lamellar structures 54 . These lamellar structures 54 are designed in such a way that they significantly improve the mobility of the heart sac 10 . Alternatively, the lamella structures 54 can also be designed as a stretched fold structure. The lamella structure or the fold structure acts similar to the bellows of an accordion. To further reduce the actuation force of the heart sac 10, groove structures 55 are optionally fitted in the walls of the left ventricle 8 and the right ventricle 9. Due to the tapering of the material in the groove structures 55, the force for moving the left-hand chamber 8 and the right-hand chamber 9 is significantly reduced.

The upper part of the heart sac 10, which faces an adaptation framework 56, consists of a flange surface 57, a peripheral edge 58 and chambers 59. The flange surface 57 has inlet openings of the heart sac 60 and outlet openings of the heart sac 75 for the flow of the blood to be transported. These inlet openings of the heart sac 60 and outlet openings of the heart sac 75 are designed in such a way that they correspond to the openings of the adaptation framework 56 . The flange surface 57 also has attachment holes for the heart sac 61 . The outer walls of the peripheral edge 58 correspond to the cardiac sacs 8 and 9, but the lamellar structure 54 or the elongated fold structure is not formed at the same time.

The first flat surface of the left chamber 49 and the first flat surface of the right chamber 51 are continued in the peripheral edge 58 up to the flange surface 57 . The second planar surface of the left ventricle 50 continued in the peripheral rim 58 and the second planar surface of the right ventricle 52 are angularly offset in this area of the peripheral rim 58 . The resulting slide chambers 59 serve to accommodate slides 62 . Structures 63 , 64 in the shape of segments of a circle are arranged centrally between the flat surfaces 49 , 50 , 51 , 52 and are suitable for receiving an axle receptacle 65 of the paddle unit 7 .

The heart sac 10 is made of a stretchable and robust plastic. The heart sack 10 consists of hypoallergenic polysiloxane with a Shore A hardness of 10 Shore to 20 Shore or a polyester. A medically harmless polyurethane with a Shore-A hardness of 10 Shore to 20 Shore is also suitable for the heart sac. Both elastomers meet the durability and reliability requirements necessary for an artificial heart.

8th shows an artificial heart base 66. The artificial heart base 66 consists of a ring with a central web 67, 74. The ring shape with the central web 67, 74 is designed in such a way that the left ventricle 8 and the right ventricle 9 of the cardiac sac 10 pass through pass through the artificial heart base 66. A first surface of heart base 68 is preferably planar. Fastening bolts 69 protrude perpendicularly from this first surface 68 . The first surface of the heart base 68 is shaped to match the flange surface 57 and the heart sac 61 attachment holes. Structures suitable for receiving the septum 11, two ball bearings 70, a cardiac sac cover 71 and the heart cover 72 are attached to the opposite side of the first surface 68 of the artificial heart base 66 .

To accommodate the ball bearings 70, two cylindrical holders 73 with bores that correspond to the diameter of the ball bearings 70 are provided in the middle. These ball bearings 70 are used for the low-friction rotatable mounting of each bearing pin 77 of the paddle unit 7.

Radially in a first half of the central web 67 is a receptacle for the septum 11, which consists of a dovetail-shaped groove 78 exists, provided. The dovetail-shaped spring 79 of the septum 11 is pushed into this dovetail-shaped groove 78 . In addition, the first half of the central web 67 supports the cylindrical supports 73 of the ball bearings 70.

In This ring-shaped groove 80 is fitted with the cover for the heart sac 71 by pushing it on axially.

A second surface of the artificial heart base 83 is provided for receiving the heart cover 82 and extends to a radial wall for receiving the heart cover 84 . This radial wall for receiving the heart cover 84 is shaped to match the shape of the inner wall of the heart cover 82 . In this way, the heart cover 82 can be slid open. The dimensions of the radial wall for receiving the heart cover 84 are dimensioned such that the heart cover 72 forms a positive connection. The artificial heart base 66 consists of a fiber-reinforced polyamide, a fiber-reinforced polycarbonate or a medically safe metal alloy.

the 9 shows an adaptation framework 56. The adaptation framework 56 is designed in such a way that the structures of the vessels in the implantation plane 32 are adapted to the entry openings of the heart sac 60 and exit openings of the heart sac 75. The four openings are openings for the left atrium 85, the aortic inlet 86, the right atrium 87 and the inlet of the pulmonary trunk 88. A first level of the adaptation framework 89 has openings 85, 86, 87, 88 that are exactly correspond to the associated openings of the implantation plane 32. A second level of the adaptation framework 90 has openings 85, 86, 87, 88 which are adapted in shape and position so that they correspond to the openings of the artificial heart sac 60,75. A streamlined smooth surface of the openings 85, 86, 87, 88 prevent thrombus formation.

Adaptation framework 86 includes adaptation framework 91 attachment holes positioned so that attachment bolts 69 of artificial heart base 66 pass through. The material of the adaptation scaffold 86 is also important in preventing thrombus formation. For this reason, the adaptation framework 86 preferably consists of a polytetrafluoroethane PTFE that is reinforced with carbon fibers.

10 shows the artificial septum 11. It has the exact surface shape of the first flat surfaces of the chambers 49, 50 of the heart sac 10. The artificial septum 11 contains a dovetail-shaped spring 79, which is dimensioned so that it fits into the shaped as a dovetail-shaped groove for the Septum 78 of the artificial heart base 66 can be inserted. The artificial septum 11 further has a central rod 92. The central rod 92 is designed to fix the cardiac sac cover 71 in the direction of the annular groove 80 of the artificial heart base 66 provided for this purpose. To do this, a nut 93 is screwed onto the central rod. The artificial septum 11 consists of a fiber-reinforced polyamide, a fiber-reinforced polycarbonate or a medically safe metal alloy.

In 11 a paddle unit 7 is shown in detail. The paddle assembly 7 includes two pivots 76, 94, two paddles 53 and two sliders 62. The pivots 76, 94 are cylindrical rods, each pivot 76, 94 having a partially flattened portion of pivot 95 at a first end. A second end of the pivots 76, 94 includes a thread of the pivots 96, 97. The pivots 76, 94 are made of medical grade steel alloy.

The paddles 53 are flat and each have the exact surface shape of the second flat surfaces of the chambers 50, 52 of the heart sac 10. The paddles 53 have cylindrical axle mounts 65 formed thereon. At a first end, which faces the artificial heart base 66, the cylindrical axle receptacles 65 contain a receptacle for the flattened section of the pivot axis 98. A rotational force can thus be transmitted to the paddle 53 via the flattened section of the pivot axis 95. The bearing pin 77 for receiving a ball bearing is also provided in this section. Hexagonal flattened areas 99 are attached to the second end of the cylindrical axle mount 65 .

The paddles 53 and the axle mount 65 consist of a fiber-reinforced polyamide, a fiber-reinforced polycarbonate or a medically safe metal alloy. The slides 62 are arranged at right angles to the paddles 53 . They consist of a pie-shaped surface 100 which is closed on three sides by further wall surfaces 101 arranged perpendicularly to this pie-shaped surface 100 . The slider 62 is dimensioned so that it can be accommodated in the slider chamber 59 of the heart sac 10 . In a paddle unit 7, the slides 62 are arranged mirror-symmetrically.

The slides 62 are preferably made of a fiber-reinforced polyamide, a fiber-reinforced polycarbonate or a medically safe metal alloy. The paddles 53, the sliders 62 and the axle mount 65 can be designed as a one-piece part in the form of the paddle unit 7.

12 shows a partially assembled artificial heart according to the invention. The heart sac 10 is placed in the artificial heart base 66 . The artificial heart base 66 with the heart sac 10 inserted is surrounded by the ring-shaped connector 45 . Furthermore, the skeletal ring 37 is also surrounded by the ring-shaped connector 45 . The septum 11 is, as in 12 is clearly visible, arranged between the left ventricle 8 and the right ventricle 9 of the heart sac 10 . In contact with the second flat surface of the left chamber 50, a first paddle 53 of the paddle unit 7 is arranged. Another paddle 53 of the paddle unit 7 is placed in contact with the second flat surface of the right ventricle 52 .

In the sectional view of the 12 further details are shown. In this sectional view, the heart sac 10 can be seen with its flange surface 57 in particular. The openings in the adaptation framework 56 on which the heart sac 10 is positioned can be seen through the openings in the flange surface 57 of the heart sac 10 . In order to fix and stabilize the heart sac 10, the artificial heart base 66 is inserted and held on it via the connector 45. The wall surfaces of the slider 101 are arranged so that they rest against the wall surfaces of the slider chambers 59 of the cardiac sac 10 .

13 already shows that 12 known partially assembled artificial heart with an additionally assembled heart sac cover 71. The shape of the heart sac cover 71 corresponds to the outer shape of the heart sac 10, with a free space 102 being contained between the heart sac cover 71 and the heart sac 10. This clearance 102 is provided to ensure optimal functioning of the cardiac sac 10. With this free space 102, the heart sac 10 has the opportunity to give way during a compression phase.

The cardiac sac cover 71 contains a flat plane 103 with three cardiac sac cover bores 104, 105, 106. The first cardiac sac cover bore 104 contains a cardiac sac cover ball bearing 107 and the second cardiac sac cover bore 105 contains another cardiac sac cover ball bearing 108. In these ball bearings the Cardiac sac cover 107, 108, the axle mounts 65 of the paddle units 7 are mounted. The third bore of the heart sac cover 106 is arranged centrally between the first bore of the heart sac cover 104 and the second bore of the heart sac cover 105 . The central rod 92 of the septum 11 extends through this third hole in the heart sac cover 106.

A nut 93 is screwed onto the central post 92 of the septum 11 . This nut 93 clamps the cover for the heart sac 71 against the artificial heart base 66 via the septum 11 . The sectional view also clearly shows how the cover for the heart sac 71 is held in the annular groove 80 of the artificial heart base 66 . The edge of the cover for the heart sac 81 is preferably shaped in such a way that it can be pushed into the annular groove 80 with a precise fit.

The sandwich construction of skeletal ring 37, peripheral ring 44, adaptation framework 56, heart sac 10 and the artificial heart base 66 can be seen in the sectional view 13 see clearly. The fastening bolts 69 attached to the artificial heart base 66 are provided for fixing this sandwich construction. These mounting bolts 69 penetrate through the heart sac mounting holes 61, adaptation framework mounting holes 91, skeletal ring mounting holes 43 and circumferential ring mounting holes 47. A nut 110 is screwed onto each mounting bolt 69 to fix these components. The nuts 110 are preferably cap nuts similar to DIN 986. This sandwich construction is enclosed by the connector 45. The bulges of the connector 48 offer space for the fastening bolts 69 with the nuts 110 screwed on. Deposits can thus be avoided.

the 14 shows a gear 138 for power transmission to the paddle units 7. In the exemplary embodiment, the gear 138 consists of a first gear wheel 5 and a second gear wheel 6. The first gear wheel 5 has teeth on a partial circumference, beginning with the start tooth 111 of the first gear wheel 5 and ending with the End tooth 112 of the first gear 5 on. A gap 113 of the first gear 5 is provided between the start tooth 111 of the first gear 5 and the end tooth 112 of the first gear 5 . The tooth sequence of the first gear wheel 5 runs counterclockwise in the first perspective shown. A hole is included in the center of the first gear 5 .

In addition, the first gear wheel 5 contains a first cylindrical extension 114 of the first gear wheel 5 in the axial direction on its first end face Direction. The diameter of the first cylindrical extension 114 of the first gear 5 is smaller than the root circle diameter of the first gear 5. In the center of the first cylindrical extension 114 of the first gear 5, a hexagonal recess 115 of the first gear 5 is included. This hexagonal recess 115 of the first gear wheel 5 accommodates the hexagonal flattened area 99 of the axle mount 65 of a paddle unit 7 . The first gear wheel 5 contains a second cylindrical extension 116 in the axial direction on its second end face. The diameter of the second cylindrical extension 116 of the first gear 5 is smaller than the root circle diameter of the first gear 5. On the second face of the first gear 5, the end tooth 112 of the first gear 5 is expanded in the axial direction to a stopper 117 of the first gear 5.

The second gear 6 has teeth starting with a start tooth 118 of the second gear 6 and ending with the end tooth 119 of the second gear 6 on a partial circumference. A gap 120 of the second gear 6 is provided between the start tooth 118 of the second gear 6 and the end tooth 119 of the second gear 6 . The tooth sequence of the second gear wheel 6 runs clockwise in the first perspective shown. A hole is included in the center of the first gear 6 . In addition, the first gear wheel 6 contains, on its first end face, a first cylindrical extension 121 of the second gear wheel 6 in the axial direction. The diameter of the first cylindrical extension 121 of the second gear 6 is smaller than the root circle diameter of the second gear 6. In the center of the first cylindrical extension 121 of the second gear 6, a hexagonal recess 122 of the second gear 6 is included. This hexagonal recess 122 of the second gear wheel 6 accommodates the hexagonal flattened area 99 of the axle mount 66 of a paddle unit 7 .

On its second end face, the second gear wheel 6 contains a second cylindrical extension 123 of the second gear wheel 6 in the axial direction. The diameter of the second cylindrical extension 123 of the second gear 6 is smaller than the root circle diameter of the second gear 6. On the second face of the second gear 6, a stopper 124 of the second gear 6 is formed. This stopper 124 of the second gear 6 is expanded to the addendum circle diameter of the second gear 6 in a segment with a width of one tooth pitch of the second gear 6 to the diameter of the second cylindrical extension 123 of the second gear 6 . On the second end face of the second gear wheel 6 there is a countersink into which a ball bearing 125 of the second gear wheel 6 is pressed.

The first gear 5 and the second gear 6 are preferably made of polyoxymethylene POM. This material ensures that the gear 138 has an extremely long service life, since no lubrication is required. Alternatively, the first gear wheel 5 and the second gear wheel 6 can be made of a metal.

15 shows, among other things, a heart cover 72 with a drive unit 136 and a holding device for the control electronics 126. The drive unit 136 contains a gear 138, which consists of at least the first gear 5 and the second gear 6, and a servo motor 3. The heart cover 72 contains a Engine mounting device 127. The engine mounting device 127 is trough-shaped in the exemplary embodiment. The engine mounting device 127 includes mounting domes 128 with holes. The servo motor 3 is pushed into the trough-shaped motor fastening device 127 and fixed via a motor cover 4 . The engine cover 4 is fixed to the fastening bosses 128 with screws, not shown here.

The engine cover 4 includes a first stopper 129 capable of limiting the amount of rotation of an assembled first gear 5 at the stopper 117 thereof. The engine cover 4 further includes a second stopper 130 configured to prevent the second gear 6 from returning beyond a starting position by means of the second gear 6 stopper 124 .

Next is in 15 to recognize the position of the first gear wheel 5 and the second gear wheel 6. The first gear 5 is mounted on the driven motor axis 131 of the servo motor 3 . In this case, the first gear wheel 5 is penetrated by an axis of rotation 76 . The second gear wheel 6 is pushed onto a cylindrical pin 132 of the engine cover 4 via the pressed-in ball bearing 125 of the second gear wheel 6 .

A heart cover flange 135 is formed to attach the heart cover 72 . The outer contour of the heart cover flange 135 corresponds to the outer contour of the artificial heart base 66. The heart cover 72 is held by the overarching connector 45.

the 16A until 16c show the function of the gear 138 and thus the drive of the paddles 53. 16A shows the paddles 53 in the rest position. Both paddles 53 point parallel in one direction. The stopper 124 of the second gear 6 rests against the second stopper 130 of the engine cover 4 in this rest position. The end tooth 112 of the first gear wheel 5 lies in front of the start tooth 118 of the second gear wheel 6.

16 b 12 shows the gear position of the first gear 5 and the second gear 6 after the first gear 5 has rotated clockwise by an angle corresponding to the angle of the gap 113 of the first gear 5. FIG. The rotation of the first gear 5 has resulted in the attached paddle 53, not shown here, being rotated at the same angle. This twisting of the paddle 53 (not shown) compresses the left chamber 8 of the heart sac 10 in the direction of the septum. So far, the second gear 6 has remained static in its home position. As a result, the paddle 53 fixed to the second gear 6 has remained motionless in its home position. This movement pattern achieves a time delay in the pumping movement of the left ventricle 8 and the right ventricle 9 of the heart sac 10 .

16 b 12 shows the time when the first gear 5 is rotated at an angle corresponding to the gap 113 of the first gear 5. FIG. At the illustrated angle of rotation of the first gear 5, the starting tooth 111 of the first gear 5 comes into contact with the starting tooth 118 of the second gear 6.

16c shows the position of the first gear 5 and the second gear 6 in their final position. As can be seen here, the teeth of the first gear wheel 5 mesh with the teeth of the second gear wheel 6 . This meshing means that the further rotational movement is transmitted to the second gear wheel 6 up to the end position of the first gear wheel 5 . In this case, the paddle 53, which is connected to the first gear wheel 5, is moved further. In addition, from the in 16 b shown position, the second gear 6 moves. As a result, the paddle 53, which is connected to the second gear 6, is now moved. This movement now also leads to a compression of the right ventricle 9 of the cardiac sac 10. Upon reaching the in 16c end position shown, the stopper 117 of the first gear 5 comes into contact with the first stopper 129 of the motor cover 4. In this end position, the left ventricle 8 and the right ventricle 9 of the heart sac 10 are compressed to the same extent.

As in the 16A until 16c can be seen, the first gear 5 has a larger diameter than the second gear 6 . As a result, the second gear wheel 6 rotates faster than the first gear wheel 5. The gear ratio between the first gear wheel 5 and the second gear wheel 6 can be used, among other things, to set the pulmonary arterial blood pressure, which is normally 10% of the systemic arterial blood pressure.

To relieve the cardiac sac 10, the first gear wheel 5 is rotated counterclockwise by the servomotor 3. The coupled to the first gear 5 second gear 6 is rotated clockwise towards its home position. Upon reaching the position as in 16 b 1, the stopper of the second gear 124 and the second stopper 130 of the engine cover 4 touch each other again. This blocking of a further movement of the second gear 6 in the clockwise direction ensures that the teeth are re-coupled in a next compression phase. In contrast to normal blood circulation, the pumping action starts from the left side of the heart. Thus, systemic circulation begins before pulmonary circulation.

Depending on physical stress such as strength training, sporting training sessions, rest periods or sleeping time, an adjustment of the heart rate is necessary. One way to achieve appropriate hemodynamics is to increase or decrease the heart rate as needed. This is done by manipulating the pause times in which the servomotor 3 is inactive. The motor speed and degree of rotation remain unchanged in the active state of the servomotor 3. For this purpose, the control unit 137 of the artificial heart communicates with an external control unit by means of a wireless connection. The wireless connection is designed in such a way that secure communication is possible through human tissue. For example, the wireless communication interface may be a proprietary wireless interface, Bluetooth, ZigBee, WLAN, or other wireless communication interface.

mit:

• 2: Für ein Hindrehen und wieder Rückkehren
• HF: Herzfrequenz
• RZ: Rotationszeit abhängig vom Rotationsgrad und Motorgeschwindigkeit
• PZ: Pausenzeit.

The pause time to reach the desired heart rate is determined as follows: $$\text{HF}=60/2*\left(\text{RZ}+\text{PZ}\right)$$

with:

• 2: For turning and returning
• HR: heart rate
• RZ: Rotation time dependent on degree of rotation and motor speed
• PZ: break time.

As a result, the heart rate is: $$\text{HF}=30/\left(\text{RZ}+\text{PZ}\right)$$

Another way to achieve matching hemodynamics is to adjust the volume of blood transported with a simulated heartbeat. For this purpose, the degree of rotation and thus the rotation time of the servo motor 3 is manipulated. The pause time is retained. The is comparable to the physiological mechanism when the two heart chambers change their degree of contractility. The adaptation of the heart stroke volume is based on the fact that the driven motor axis 131 of the servomotor 3 has a rotation speed dependent on the power supply. In this way, the volume of blood transported can be adjusted by increasing the angle of rotation and changing the speed of rotation in inverse proportion. The heart rate can be kept constant. A combination of both hemodynamic adjustments can also be used to achieve improved adjustment.

In the exemplary embodiment, the control unit 137 consists of the control electronics, a microcontroller, a motor interface, a wireless communication interface, wireless charging current transmission, a sensor system and a rechargeable battery. The microcontroller controls and monitors the entire functionality of the artificial heart.

The microcontroller runs a program code that controls the rotational movement of the servomotor 3 . The servomotor 3 generates a rotary motion on its driven motor axis 131. The driven motor axis 131 is connected to the first gear wheel 5, the axis of rotation 76, and the paddle unit 7. The rest position of the paddle unit 7 corresponds to an angle of 0°. The servomotor 3 is prompted via the motor interface to start up its pre-programmed degree of rotation. The paddle 53 connected to the first gear 5 is thus moved to this angle. As a result, the left ventricle 8 of the cardiac sac 10 is compressed.

The compression of the left ventricle 8 causes the blood in the left ventricle 8 to be expelled through the aortic and pulmonary openings via the adaptation framework 56 into the bloodstream. The slider 62 pushed in by this movement ensures that the blood is not pressed into the connected atrium when the respective chamber 8 of the cardiac sac 10 is compressed. Rotation of the paddle 53 also moves the slider 62 in the same rotational motion. The slide 62 moves in its chamber 59 of the heart sac 10. The slide 62 supports the compression of the chambers 59 of the heart sac 10 on the one hand and on the other hand temporarily closes the respective atrial opening 33, 35.

When the end position is reached, the servomotor 3 remains in this position for a specified time. During this time, the pressure in the respective chamber is preferably maintained for a short time so that sufficient blood is transported through the artificial heart. Then the servo motor 3 moves the paddle 53 connected to the first gear wheel 5 back to the basic position of 0°.

The servo motor 3 remains in this basic position for another specified time. During this time, the left ventricle 8 of the cardiac sac 10 fills with blood.

A negative pressure is formed in the left-hand chamber 8 as a result of the movement of the paddle 53 into the basic position. The blood is sucked into the left ventricle 8 of the cardiac sac 10 by this negative pressure. Since the first gear 5 is directly connected to the driven motor axis 131 of the servo motor 3, the rotational movement of the paddle 53 is simultaneous to the movement of the driven motor axis 131.

In contrast, the paddle 53 connected to the second gear 6 performs a delayed movement. The delay time is determined by the gap 113 of the first gear 5 in which the first gear 5 has no teeth. The toothless gap 113 in the first gear wheel 5 serves to ensure that the rotational movement of the first gear wheel 5 is only transmitted to the second gear wheel 6 intermittently and not simultaneously. Since the gap 113 of the first gear 5 covers a predetermined angle, a predetermined time elapses to bridge this gap 113 of the first gear 5 . The engine speed determines the duration of this time, which is necessary to overcome this gap 113 of the first gear wheel 5.

With the end of the gap 113 of the first gear 5, the second gear 6 is moved by the teeth of both gears. The movement of the second gear wheel 6 is transmitted to the paddle unit 7 connected thereto. A pumping action of the right ventricle 9 of the heart sac 10 is carried out via the paddle unit 7 . If the first gear 5 returns to its original position, this means that the second gear 6 is also moved back to its home position. Due to the different diameters of the first gear wheel 5 and the second gear wheel 6, the right-hand chamber 9 before the left-hand chamber 8 is refilled with blood. The right-hand chamber 9 is already filling up completely while the first gear wheel 5 is still moving in the area of the gap 113 in the first gear wheel 5 .

17 a shows the artificial heart according to the invention in the fully assembled state. The circular opening in heart cover 72 is for illustration only and is not included in heart cover 72 . A large part of the components of the artificial heart has already been discussed in detail received. In the previous description, however, the attachment of the artificial heart was not discussed. Therefore, the attachment of the artificial heart will be described in detail below.

The angle adjustment system 1 already described provides a receptacle and a rack and pinion drive 26 for a rack 31 . The rack 31 contains a ball joint 134 at its end protruding from the adjustment arm 13. This ball joint 134 connects a distal cuff 2 to the rack 31. To secure the position of the artificial heart at the implantation site, it is sufficient that the artificial heart only in the distal cuff 2 is inserted. For this purpose, the distal cuff 2 is shaped in such a way that it exactly encloses the heart cover 72 at its closed end. If further fixation of the heart cover 72 in the distal cuff 29 is required, retaining clips (not shown here) can be provided in the distal cuff 2 .

In 17 a a line connection 133 is shown. The artificial heart is connected to the accumulator associated with the control electronics via this line connection 133 . The accumulator is not integrated directly into the artificial heart since it is a so-called wearing part. Therefore, easy access must be guaranteed. This is achieved because this battery is implanted subcutaneously, ie close to the skin's surface. Another task of the line connection 133 is also the outsourcing of the wireless communication and the wireless energy coupling for charging the battery. The necessary components are also to be implanted directly under the skin surface. In particular, heat-related power losses when charging the battery are minimized.

the 17 b shows a sectional representation of the artificial heart at the cutting edge AA 17 a . The installation position of the control electronics on the holding device for the control electronics 126 can be seen particularly well here. The control electronics 137 are mounted in a holding device for the control electronics 126 of the heart cover 72 . In this representation, the fixation of the heart cover 72 by the connector 45 is shown once again.

In a further embodiment, the artificial heart according to the invention contains a second servomotor. With the help of the second servo motor, it is possible to operate each paddle individually. This makes it possible to achieve significantly greater flexibility in terms of the sequence of actuation and the rate of actuation of the chambers of the heart sac. It is also possible to dispense with a gear.

the 18 shows a method, described below, for assembling the artificial heart according to the invention.

In a first step, the angle adjustment system 1 is fixed to a spine S101. The base 12 is positioned and tightened by means of the sliding nuts 17 by two spine screws. Now the angle is determined S102. The angle is determined S102 and the correct position S114 of the artificial heart is subsequently set using the determined angle by exerting pressure on the adjustment arm 13 in the direction of the angle housing 8. The pressure releases the contact between the toothed surfaces of the first toothed disk 19 and the second toothed disc 20, and thus the adjustment arm 13 can be rotated on the base 8. If the pressure is released, the spring 22 built into the angle housing 8 presses the first toothed disc 19 against the second toothed disc 20. The teeth 15 are thus engaged again and thereby fix the adjustment arm 13 in its new position.

In a second step, the skeletal ring 37 is connected to the cardiac structures S103. In preparation, the connector 45 is placed on the skeletal ring 37 so that the connecting sleeve of the skeletal ring 37 penetrates the connector 45 . Now the peripheral ring 44 is pulled over the skeletal ring 37 and under the connector 45 S103. The vessels and atria of the prepared implantation site are connected to the connection sleeve provided for the left atrium 38, to the connection sleeve for the aorta 39, to the connection sleeve for the right atrium 40 and to the connection sleeve for the pulmonary trunk 41 of the skeletal ring 37 S104 .

In a further step, the heart sac 10 is placed in the artificial heart base 66 S105. The left ventricle 8 and the right ventricle 9 of the heart sac 10 penetrate the artificial heart base 66 . The adaptation frame 56 is mounted S106 on the unit consisting of the artificial heart base 66 and the heart sac 10 . In this case, the adaptation framework 56 is aligned in such a way that its openings in the second plane of the adaptation framework 90 are oriented in accordance with the openings in the cardiac sac 10 . Now the adaptation framework 56 is fitted over the fastening bolts 69 of the artificial heart base 66, so that the second level of the adaptation ge frame 90 rests flat on the flange surface 57 of the heart sac 10 .

In a next step, the septum 11 with its dovetail-shaped tongue 79 is pushed radially into the dovetail-shaped groove of the receptacle for the septum 78 of the artificial heart base 66 S107. The paddle units 7 are now assembled. Each paddle unit 7 is positioned between the two chambers of the heart sac 10 S108 and the upper end of the paddle unit 7 is inserted into the ball bearings 70 that are pressed into the artificial heart base 66 . The two slides 62 are inserted in the correct position in the baskets 59 of the heart sac 10 assigned to the left ventricle 8 and the right ventricle 9 .

In a subsequent step, the cover for the heart sac 71 is mounted S109. For this purpose, the cover for the heart sac 71 is pushed with its outer edge into the ring-shaped groove 84 of the artificial heart base 66 provided for this purpose. The axle mounts 65 of the paddle units 7 are inserted into the associated ball bearings 107, 108 during the insertion process. The central rod 92 of the septum 11 is inserted into the third hole in the heart sac cover 106 provided for this purpose. Finally, the cardiac sac cover 71 is fixed to the central post 92 of the septum 11 with a nut.

The unit preassembled in this way is now placed on the skeleton ring 37 and the peripheral ring 44 S110. This preassembled unit is aligned in such a way that the openings in the adaptation frame 56 match the openings in the skeleton ring 37 . The corresponding nuts 110 are now screwed onto the fastening bolts 69 protruding from the peripheral ring 44 . Now these nuts 110 are tightened crosswise step by step. When tightening crosswise, the opposite nuts 110 are always tightened in pairs. This avoids tension caused by uneven tightening.

the 19 Fig. 12 shows a method for pre-assembling a unit enclosed by the heart cover 72, with the following independent steps: The servo motor 3 is inserted into the motor attachment device 127 of the heart cover 72 provided for it S201. The motor attachment device 127 with the servo motor 3 is closed by a motor cover 4 . The engine cover 4 is screwed into the fastening bosses 128 provided for this purpose.

To assemble the gear S202, the first gear wheel 5 is pushed onto the driven motor axis 131 of the servomotor 3 in the basic position. A first axis of rotation is screwed at its long thread 96 through the first gear wheel 5 into the driven motor axis 131 . A second axis of rotation 94 is screwed into the second gear wheel 6 at its short thread 97 . The second gear wheel 6 with the screwed-in axis of rotation 94 is pushed onto the cylindrical pin 132 of the motor cover 4 at its pressed-in ball bearing of the second gear wheel 125 . The control electronics are attached to the holding device for the control electronics 126 S203 and the connection to the servo motor 3 is established. In addition, the line connection 133 to the accumulator and the receiver for the charging energy is led out from the heart cover 72 S204.

Now, the unit enclosed by the heart cover 72 is mounted on the unit enclosed by the heart sac cover 71 S111. It is particularly important to ensure that all moving parts are in the home position. The two pre-assembled rotary axes 76, 94 are inserted into the axle mounts 65 provided for this purpose. Now the unit enclosed by the heart cover 72 can be fully slid onto the unit enclosed in front of the cardiac sac cover 71 . The hexagonal flattened areas 99 of the axle mounts 65 of the paddle units 7 slide into the hexagonal recess provided for this purpose in the first gear wheel 115 and the hexagonal recess 122 provided for this purpose in the second gear wheel 6. At the same time, the flattened section of the rotary axles 95 slides into the intended receptacle for the flattened Section of the axis of rotation 98.

Both units are now pushed onto one another in such a way that the heart cover flange 135 lies flat on the second surface of the artificial heart base 83 . To fix the heart cover 72, the connector 45 is pulled over the heart cover flange 135 S112 so that the connector 45 encloses the peripheral ring 44, the skeletal ring 37, the adaptation framework 56, the heart sac 10, the artificial heart base 66 and the heart cover flange 135. Thus, the components described are held together as a single unit.

In a final step, the unit held together by the connector 45 is inserted S113 into the distal cuff 2 at the end of the heart covering 72 opposite the adaptation framework 56 . The distal cuff 2 is connected to a toothed rack 31 via a ball joint 134 . The toothed rack 31 is pushed into the adjustment arm 13. Via the triangular recess 30 on the rack drive 26, the rack is extended or retracted in the adjustment arm 13, depending on the direction of rotation. Thus, the horizontal position of the artificial heart set. When the desired position is reached, the securing element 29 is pushed in S114. This prevents the horizontal position from being adjusted even if the toothed wheel of the toothed rack drive 27 is rotated. The connection between the adjustment arm 13 and the toothed rack 31 in combination with the securing element 29 seals the angle adjustment system 1 in such a way that fibrin deposits inside the device are prevented.

the 20 shows a further embodiment of the artificial heart according to the invention. A sealing disk 140 is arranged between the adaptation frame 56 and the flange surface 57 of the cardiac sac 10 . The outer contour of the sealing disk 140 corresponds exactly to that of the adaptation framework 56. In addition, the sealing disk 140 contains openings which correspond to the entry openings of the heart sac 60 and the exit openings of the heart sac 75 (not shown here). A sealing ring 141 is arranged on the side of the flange surface 57 of the cardiac sac 10 that faces away from the adaptation framework 56 . The sealing ring 141 lies flat on the flange surface 57 of the heart sac 10 . The sealing ring 141 encompasses the flange surface 57 in such a way that the sealing ring 141 and the sealing disk 140 come into contact. The outer contour of the sealing ring 141 corresponds exactly to the outer contour of the sealing disk 140.

The sealing ring 141 further includes an opening shaped so that the peripheral edge 58 of the cardiac sac 10 fits snugly thereon. The flange surface 57 of the heart sac 10 is pressed against the sealing disc 140 by the sealing ring 141 without being squeezed. The other components such as the septum 11 with the central rod 92, the paddles 53 and the washers 62 are attached in accordance with the first embodiment. This additional arrangement consisting of the sealing disc 140 and the sealing ring 141 enables a further reduction in the backflow of blood into the corresponding atria.

Within the scope of the invention, all of the elements described and/or drawn and/or claimed can be combined with one another as desired. In particular, combining the described embodiments is not ruled out.

Claims (10)

Artificial heart with a heart sac (10), a paddle unit (7), a drive unit (136) and a control unit (137), the heart sac (10) consisting of two chambers (8, 9), each of which has an entry opening (60) and each have an outlet opening (75), wherein the drive unit (136) causes the paddles (53) of the paddle unit (7) to rotate, and wherein the control unit (137) determines the angle and/or angular speed of the paddles (53) of the paddle unit ( 7) controls, characterized in that the paddle unit (7) contains at least one slide (62), that the slide (62) is coupled to the rotational movement of the paddle unit, and that the inlet opening (60) of the chamber (8, 9) through the slide (62) can be closed. artificial heart after claim 1 , wherein the paddle unit (7) contains one paddle (53) per chamber (8, 9), and/or wherein the paddle unit (7) is designed in such a way that a volume limited by the heart sac (10) is continuously variable as a result of the rotational movement . artificial heart after claim 1 or 2 , wherein between the two chambers of the cardiac sac (10) a first (49, 51) and a second (50, 52) flat surface is formed at each chamber, wherein between the first flat surfaces (49, 51) a septum (11) is attached, and wherein the paddle unit (7) is arranged between the second planar surfaces of the heart sac (10). Artificial heart according to one of the Claims 1 until 3 , wherein the drive unit (136) has a gear (138) containing at least two partially toothed gears (5, 6), and wherein the partially toothed gears (5, 6) are designed such that the paddles (53) of the paddle unit (7) are coupled by the gear (138) and are moved with a time delay. Artificial heart according to one of the Claims 1 until 4 , wherein the drive unit (136) has at least one servo motor (3), wherein the servo motor (3) contains a sensor for detecting the angle and / or the angular velocity of the paddle (53). artificial heart after claim 5 , wherein the control unit (137) has a microcontroller, a communication unit and a motor interface, wherein the microcontroller is configured such that the artificial heart generates an artificial heartbeat, wherein the communication unit provides a contactless data connection for the transmission of default values and/or measured values, and wherein the control unit (137) controls the servomotor (3) with the aid of the motor interface and/or detects the angles and/or angular speeds determined by the sensors of the servomotor (137). Artificial heart according to one of the Claims 1 until 6 , wherein the artificial heart has a heart cover (71) and a skeletal ring (37), the heart sac (10), the paddle unit (7), the control unit (137) and the drive unit (136) being enclosed by the heart cover (72). , and wherein the skeleton ring (37) in the region of the inlet openings (60) and the outlet openings (75) of the heart sac (10) closes off the heart cover (72). artificial heart after claim 7 , the artificial heart having a cuff (2) and an angle adjustment system (1), the cuff (2) at least partially enclosing the heart cover (72), and the artificial heart being attached to the cuff (2) with the aid of the angle adjustment system (1 ) is fixed. Artificial heart according to one of the Claims 1 until 8th , wherein the artificial heart contains an energy store, wherein the energy store can be charged without contact, and/or wherein the heart sac (10) consists of a hypoallergenic polysiloxane or polyester with a Shore A hardness of 10 Shore to 20 Shore. Artificial heart according to one of the Claims 1 until 9 , the artificial heart having an adaptation framework (56), the adaptation framework (56) containing at least one opening (85, 86, 87, 88), the at least one opening (85, 86, 87, 88) being designed in such a way that it connects the inlet openings (60) and the outlet openings (75) of the cardiac sac (10) with at least one corresponding connecting sleeve (38, 39, 40, 41) of the skeletal ring (37).

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