Plug system for a heart support device

Abstract

Device for supporting the function of a heart, comprising: an implant, a supply unit that can be coupled to the implant, a cable that includes at least one pneumatic line and at least one electrical line, a plug system with at least one connection for a pneumatic line and at least one connection for an electrical line.

Description

Summary

[0001] The present invention relates to a device for supporting the function of a heart, comprising an implant, a supply unit that can be coupled to the implant, and a cable comprising at least one pneumatic line and at least one electrical line. The device includes a connector system with at least one connection for a pneumatic line and at least one connection for an electrical line. The connector system can comprise at least a first connector part, which can be a male connector part. The connector system can comprise at least a second connector part, which can be a female connector part. background

[0002] The invention relates to a device for supporting the function of a heart. In particular, the device according to the invention serves to support the pumping function of the heart.

[0003] Disease can reduce the heart's pumping function, a condition also known as heart failure. Heart failure is of great and growing importance from both a medical and economic perspective. In the second decade of this century, 23 million people worldwide will suffer from heart failure, with an annual incidence rate of 2 million new cases. In the USA alone, approximately 5 million people currently suffer from heart failure, with an annual incidence rate of around 550,000 new cases. Within this decade, the number of people over 50 in the USA alone will more than double to over 10 million. The same applies to the European continent.

[0004] Heart failure can be caused by impaired contractility or filling of the heart due to damage to the heart muscle. High blood pressure can lead to increased resistance to pumping, which can also negatively affect the heart's pumping function. A heart's pumping function can also be reduced by leaky valves, such as a leaky aortic or mitral valve. Impaired electrical conduction in the heart can also lead to reduced pumping capacity. If the heart's movement is restricted externally, for example by fluid accumulation in the pericardial sac, this can also result in reduced pumping function. Heart failure often leads to shortness of breath (especially in left-sided heart failure) or fluid accumulation in the lungs (especially in left-sided heart failure) or in the legs or abdomen (especially in right-sided heart failure).

[0005] Various types of heart failure can be treated with medication or surgery. Under certain conditions, disturbances in the heart's electrical conduction can be treated with a pacemaker. A defective heart valve can be surgically replaced with a prosthetic valve. Reduced pumping capacity can be treated by implanting a heart pump. A treatment approach that encompasses the various causes of heart failure is to support the heart's pumping function with an implant that exerts mechanical pressure on the heart, thereby improving its pumping capacity.

[0006] Previously known mechanical ventricular assist devices (VADs) are disclosed, for example, in US patents 5,749,839 B1 and 6,626,821 B1, and in WO 00 / 25842 A1. These documents disclose mechanical VADs that have the disadvantage that implantation requires open-chest surgery. Current VAD systems are complex and can only be implanted through extensive surgery. All of them are integrated into the patient's circulatory system. Improved centrifugal pumps or magnetically levitated impeller systems continuously circulate the blood. The contact of the blood with the foreign surface of these systems presents a significant technical and medical challenge. Common complications of these systems include strokes, bleeding, and infections.They often lead to long-term hospitalization and frequent readmissions of patients who have already been discharged from the hospital.

[0007] DE 10 2009 043 795 A1 discloses a cardiac support device with inflatable chambers and sensors but no plug system.

[0008] US 2010 / 0256441 A1 reveals a cardiac compression system with chambers and tubes but no plug system.

[0009] Thomas Maier's technical article on multiple couplings discloses multiple couplings for industrial purposes, such as grippers or robots. The article does not disclose a heart support device or a connector system with a cable that includes at least one pneumatic and at least one electrical line.

[0010] The object of the present invention is to provide a cardiac support device that does not have the disadvantages of known cardiac support devices.

[0011] The present invention relates to a device for supporting the function of the heart. Generally, the device can be implanted minimally invasively using a catheter. The device generally has no direct contact with blood vessels and is not inserted into a vascular system. Summary of the invention

[0012] The device for supporting the function of a heart comprises a connector system with at least one connection for a pneumatic line and at least one connection for an electrical line. The connector system serves to connect the device to a power supply unit.

[0013] The plug system consists of a first male plug part and a second female plug part, which can be connected to each other.

[0014] Additionally, the interconnected plug parts can be secured with a locking mechanism.

[0015] A seal can be located inside or outside the connector parts. Each pneumatic and / or electrical line can have its own seal.

[0016] The connector system can be attached to an implant, and the female connector part can be located on the side facing the implant. A female connector part on the implant side (e.g., the device for supporting heart function) can be advantageous because, unlike the male connector part, it does not have any protruding pins or other contacts that could break. When replacing a supply unit that feeds the device, the connector system must be disconnected, and a new supply unit attached. If a pin breaks, replacing the supply unit is simpler than replacing the device for supporting heart function. Therefore, a male connector part on the supply unit side is advantageous.

[0017] The device may include a cable, which may be fitted with strain relief elements at its ends. The cable may have a sheath that reinforces it.

[0018] Further features and advantages of the invention will become apparent from the following description and from the following drawings, to which reference is made. Description of the drawings Fig. Figure 1 shows a human torso with the device according to the invention, wherein a supply unit is located extracorporeally. Fig. Figure 2 shows a human torso with the device according to the invention and a partially implanted supply unit. Fig. Figure 3 shows a human heart with the device according to the invention. Fig. 4a and Fig. Figure 4b shows a section through the heart with the device according to the invention along the in Fig. 3 shown line AA. Fig. Figure 5 shows a step in the implantation of the device according to the invention. Fig. Figure 6 shows a step of the implantation procedure in which a pericardial closure has not yet been screwed in place. Fig. Figure 7 shows a step of the implantation procedure in which a pericardial closure is screwed in place. Fig. Figure 8 shows a partially expanded shell with a covering. Fig. Figures 9a-c show different views of a closed pericardial closure. Fig. Figure 10 shows a tool for closing a pericardial closure. Fig. Figure 11 shows a plug system of the device according to the invention. Fig. Figure 12a shows a heart with anatomical landmarks. Fig. Figure 12b shows a cross-section through the heart. Fig. 12a. Fig. Figure 13a shows a 3D view of part of a heart with a coordinate system. Fig. Figure 13b shows a 2D roll-up of the 3D view from Fig. 13a with a coordinate system. Fig. Figure 14a shows a 3D view of a shell with augmentation and positioning units. Fig. Figure 14b shows a 2D unrolling of the shell with augmentation and positioning units made of Fig. 14a. Fig. Figures 15a-b show a compressed and an expanded augmentation unit in the form of a chamber with a bellows-shaped section. Fig. Figure 16a shows a 3D view of a shell with sensors and / or electrodes. Fig. Figure 16b shows a 2D unrolling of the shell with sensors and / or electrodes made of Fig. 16a. Fig. Figure 17 shows an embodiment of a shell with augmentation and positioning units. Fig. Figure 18 shows an embodiment of a shell with sensors and electrodes. Detailed description

[0019] The device according to the invention comprises several components, which are explained in more detail in the following sections, wherein embodiments of the individual components can be combined with one another. The claimed device is defined in the claims.

[0020] Fig. Figure 1 shows an embodiment (10) of the device according to the invention in the implanted state. By way of example, the device according to the invention is implanted in a human body. However, the device according to the invention can also be implanted in an animal body, in particular in the body of a mammal, such as a dog, a cat, a rodent, a primate, an even-toed ungulate, or an odd-toed ungulate. Depending on the species, special adaptations of the shape and function of the device according to the invention may then be necessary to meet the anatomical and / or physiological needs of the individual species.

[0021] Fig. Figure 1 shows a human torso with the device according to the invention. The device consists of a shell (2) that can at least partially enclose the heart (61), wherein components are incorporated into the shell (2) that support the function of the heart (61). Furthermore, the device includes a supply unit (30).

[0022] The shell (2), which can at least partially enclose the heart (61), can transition from a non-expanded state to an expanded state. Preferably, the shell (2) is self-expanding and can be introduced into a delivery system in the non-expanded state. The shell (2) can consist of a mesh, in particular a wire mesh, wherein the wire mesh can be made at least partially of a shape-memory alloy. In the implanted state, the shell (2) at least partially encloses the heart (61) and is located within the pericardium (6). Embodiments in which the shell (2) is placed outside the pericardium (6) are also possible.These embodiments are not described separately; rather, the description applies to embodiments for implantation inside and outside the pericardium (6) (with the exception of the non-essential pericardial closure (5) in embodiments of the shell (2) for implantation outside the pericardium (6). The structure of the shell (2) is explained in more detail in a later section of the description.

[0023] The expandable shell (2) contains at least one expandable unit by means of which pressure can be exerted on the heart (61). The expandable unit can be a mechanical unit that can assume an expanded and a non-expanded configuration. Such a mechanical unit can consist of spring elements that can be tensioned and relaxed, or of lever elements that can be folded and unfolded. Preferably, the expandable units are chambers that can be filled with a fluid. Suitable fluids for filling a chamber include liquids, gases, or solids (such as nanoparticle mixtures), or mixtures of liquids and / or gases and / or solids. The at least one expandable unit can be mounted in the shell (2). Preferably, the at least one expandable unit is mounted on a shell that can be inserted into the shell (2).The at least one expandable unit will be explained in more detail in a later section of the description.

[0024] The dish (2) can further comprise at least one sensor and / or one electrode by means of which at least one parameter of the heart (61) can be detected. The at least one sensor can be suitable for determining the heart rate, the ventricular pressure, the contact force between the heart wall and the at least one expandable unit, the systolic blood pressure, or the diastolic blood pressure. The sensor can also be suitable for measuring the pressure exerted by an expandable unit on a surface, the pH value, the electrical resistance, the osmolarity of a solution, or the flow rate through a vessel. The at least one sensor can be attached in, to, or on the dish (2). Preferably, the at least one sensor is attached to a casing that can be inserted into the dish (2).In addition to or instead of the at least one sensor, the dish (2) can also include at least one electrode suitable for measuring a parameter such as the action potential in the heart muscle during the excitation process or for stimulating tissue with currents. The at least one sensor can also be an electrode. The at least one sensor and / or the at least one electrode will be explained in more detail in a later section of the description.

[0025] Fig. Figure 1 shows a supply unit (30) that can be worn outside the body. The supply unit can also be partially or completely implanted into the body, which will be explained in more detail in the following paragraphs. When worn outside the body, the supply unit (30) can be attached to a chest strap, a hip belt, or a waist belt. The supply unit (30) has an energy storage device that powers at least one expandable unit. The energy storage device can be in the form of a battery that provides electrical energy to expand the expandable unit. The battery is replaceable. The supply unit (30) can also contain a pressure reservoir that provides a compressed gas to inflate an inflatable chamber. Suitable gases include compressed air, CO2, or noble gases.The housing of the power supply unit (30) itself can serve as a pressure storage housing. The power supply unit (30) can also contain pumps, valves, sensors, and displays. Furthermore, the power supply unit (30) can include a microprocessor capable of receiving and processing data from the at least one sensor. If the power supply unit (30) is worn outside the body, the energy to be provided can be transferred via a direct connection using a cable (4) or wirelessly, for example, by electromagnetic induction. The data from the at least one sensor can also be transmitted directly via a cable (4) or wirelessly using a radio technology such as Bluetooth.

[0026] The device according to the invention can further comprise a cable (4) that connects the at least one expandable unit and / or the at least one sensor or the at least one electrode to the power supply unit (30). If the power supply unit (30) is directly connected to the at least one expandable unit and / or the at least one sensor or the at least one electrode, a cable (4) can be omitted. If the at least one expandable unit is a mechanical unit that can transition from a non-expanded state to an expanded state or from an expanded state to a non-expanded state with the aid of electrical energy, the cable (4) includes conductors suitable for transferring the necessary energy from the power supply unit (30) to the expandable unit.If the at least one expandable unit is a chamber that can be filled by means of a fluid, the cable (4) includes at least one line that enables the flow of fluid from the supply unit (30) into the chamber. The device according to the invention comprises a cable (4) that includes at least one pneumatic or hydraulic line and at least one electrical line. If the device includes a sensor or an electrode on, in, or on the shell, the at least one line leading to the sensor or the electrode can also be in the cable (4). Embodiments may also have separate cables for supplying energy to the at least one expandable unit and to the at least one sensor or the at least one electrode.

[0027] The cable (4) connecting the power supply unit (30) to the at least one expandable unit and / or the sensor or electrode can be a single, continuous cable or a multi-part cable. In the case of a continuous cable, a cable (4) can be located at the at least one expandable unit and / or the at least one sensor or electrode. A connector (90) can then be attached to the end of the cable (4), which can be connected to the power supply unit (30) via the connectable port (91). Alternatively, a cable with a connector is located only at the power supply unit (30). In this case, the connectable port is located on the housing (2) containing the at least one expandable unit and / or the at least one sensor or electrode.In the case of a multi-part cable, a cable (4) with a connector (91) can be attached to the at least one expandable unit and / or to the at least one sensor or electrode, and a cable can also be attached to the power supply unit (30), preferably also having a connector at its end. The cable (4) will be explained in more detail in a later section of this description. The connector (90) will be explained in more detail in a later section of this description.

[0028] Fig. Figure 2 shows an embodiment (11) of the device according to the invention in the implanted state, in which the supply unit (31) is implanted in the body. Preferred sites for the implantation of the supply unit (31) are the thoracic cavity and the abdominal cavity, which are separated from each other by the diaphragm (63).

[0029] The in Fig. The shell (2), the pericardial closure (5), and the cable (4) of the device shown in Figure 2 correspond essentially to those shown in Figure 2. Fig. The components shown in Figure 1 correspond to the power supply unit (31). The power supply unit (31) can include an energy storage device that can power the at least one expandable unit located in the shell (2). The energy storage device can be in the form of a battery that provides electrical energy to expand the expandable unit. The power supply unit (31) can also include sensors and one or more microprocessors. If the at least one expandable unit consists of at least one chamber that can be filled with a fluid, the power supply unit (31) can include pumps, valves, and a pressure accumulator. The pressure accumulator can provide a compressed gas to inflate an inflatable chamber. Suitable gases include compressed air, CO2, or noble gases. The housing of the power supply unit (31) itself can serve as the pressure accumulator housing.A preferred site for implanting the supply unit (31) is right-lateral in the thoracic cavity above the liver (62) and above the diaphragm (63). Alternatively or additionally to the pressure reservoir in the supply unit (31), a pressure reservoir (32) can preferably be implanted right-laterally in the abdominal cavity below the diaphragm (63) and above the liver (62). The pressure reservoir (32) can be connected to the supply unit (31) by means of a tube (33) that penetrates the diaphragm (63). The opening in the diaphragm required for the insertion of the tube (33) can be sealed with a closure device. This closure device can be designed similarly to the pericardial closure device described in this application. The supply unit can be connected directly to the at least one expandable unit and / or the sensor or electrode by means of a cable (4).Alternatively, a connector can be located at one end of the cable (4) which can be connected via a coupling port to the power supply unit (31) or to the at least one expandable unit and / or the sensor or electrode. The cable (4) preferably runs in the thoracic cavity above the diaphragm (63). In the case of a multi-part cable, a cable with a connector can be attached to the at least one expandable unit and / or the at least one sensor or electrode, and a cable with a coupling port can also be attached to the power supply unit (31).

[0030] Alternatively or additionally to a battery contained in the power supply unit (31), a battery (34) can preferably be implanted subcutaneously in the abdominal wall. The energy required in the power supply unit (31) can be transferred, for example, by electromagnetic induction from an extracorporeal control unit (35) transcutaneously to the battery (34) and transmitted from the battery (34) to the power supply unit (31) by means of an electrical cable (36). The extracorporeal control unit (35) can include, among other things, a replaceable battery and / or a charger. The extracorporeal control unit (34) can include, among other things, microprocessors and displays that can be used for system monitoring of the device and for displaying the operating status. The data from the at least one sensor can be transmitted wirelessly to and between the power supply unit (31) and the control unit (34) via a radio technology, such as Bluetooth.

[0031] Fig. Figure 3 shows by way of example a human heart (61) as well as a shell (2), a casing (7) with expandable units (71, 72), a casing (80) with sensors (81) and / or electrodes (82), a cable (4) with a connector part (90), a catheter (103) of a delivery system and a pericardial closure (5) of the device according to the invention.

[0032] In this embodiment, the bowl (2) is shown in the form of a wire mesh. Alternatively, instead of a wire mesh, the bowl (2) can be formed from a grid consisting of struts. In this case, struts form a grid with openings. The bowl (2) can also consist of a continuous material from which parts have been removed; for example, the bowl (2) can consist of a tube or a custom-shaped shell into which holes have been formed or cut.

[0033] The in Fig. The shell (2) shown in Figure 3 consists of a wire mesh. The wires form intersections that can be firmly connected to one another. For example, the wires can be welded together at the intersections. Connecting the wires at the intersections increases the stability of the shell (2). Alternatively, the intersections can remain unconnected. This can increase the flexibility of the shell (2) and thus make it easier to compress. This can be particularly helpful when the shell (2) is to be inserted into a delivery system with a catheter (103) of a smaller diameter. The shell (2) can also be firmly connected at some of the intersections and not at others.The stability and flexibility of the shell (2) can be adjusted by appropriately selecting crossing points that are rigidly connected and crossing points that are not. Areas requiring increased stability in the implanted state can be stabilized by connecting the wires at crossing points. These may be, for example, areas that serve as abutments for expandable units (71, 72). Such abutments may be located directly beneath an expandable unit (71, 72) or adjacent to areas with expandable units (71, 72). Areas requiring increased flexibility may be those that need to be compressed more than other areas when inserted into a delivery system. Areas requiring increased flexibility may also be those where increased flexibility supports the natural movement of the heart.If the shell (2) does not consist of a wire mesh but of a lattice structure or a shell shell with holes, the stability and / or flexibility of the shell (2) can also be adjusted in specific areas. Adjustments can be achieved in these cases by selecting the strut width and / or strut thickness, by selecting the material used, or by altering the material in specific areas through the action of, for example, energetic radiation such as heat. Preferably, the shell (2) has openings formed by the wires of a wire mesh, the struts of a lattice structure, or the holes in a shell shell. These openings allow the shell (2) to be compressed, permit the exchange of material between the interior of the shell (2) and areas outside the shell (2) and vice versa, reduce the amount of material required for the shell (2), and allow for increased flexibility of the shell (2).Shapes that are difficult to achieve with continuous materials are easier to form with woven or grid-like structures. The openings can be square, diamond-shaped, round, or oval. The openings defined by the wires, struts, or holes in a shell have a diameter of approximately 1 mm to 50 mm, preferably 3 mm to 30 mm, and preferably 5 mm to 20 mm. The diameter of an opening is defined as a pin opening, meaning that the diameter of the opening represents the largest diameter of a cylindrical pin that can pass through the opening (a cell, a hole).

[0034] The shell (2) preferably consists of a material that allows expansion. Preferably, the shell (2) is formed from a material selected from the group consisting of nitinol, titanium and titanium alloys, tantalum and tantalum alloys, stainless steel, polyamide, polymer fiber materials, carbon fiber materials, aramid fiber materials, glass fiber materials, and combinations thereof. For a self-expanding shell (2), a material that is at least partially made of a shape memory alloy is suitable. Examples of shape memory alloys are NiTi (nickel-titanium; nitinol), NiTiCu (nickel-titanium-copper), CuZn (copper-zinc), CuZnAl (copper-zinc-aluminum), CuAlNi (copper-aluminum-nickel), FeNiAl (iron-nickel-aluminum), and FeMnSi (iron-manganese-silicon).

[0035] The shell (2) preferably has a shape adapted to the individual heart shape of the patient or a cup-shaped shape. The individual heart shape of the patients can be reconstructed from CT or MRI image data. The shell (2) is open at the top. The upper edge of the shell (2) preferably has loops of a wire or brackets formed by struts. The loops or brackets can serve as anchor points for a sheath (80) with at least one sensor (81) or an electrode (82) and / or for a sheath (7) with at least one expandable unit (71, 72). At the lower end of the cup-shaped shell, there is preferably an opening through which one or more leads of the at least one sensor (81) or the at least one electrode (82) and / or the at least one expandable unit (71, 72) can be passed.The shape of the bowl (2) represents, at least in part, the shape of a natural heart (61), preferably the lower part of a heart (61). Details of the shape of the bowl (2) will be explained in more detail in a later section of the description.

[0036] The shell (2) can be covered with a membrane (21), in particular a membrane (21) made of polyurethane or silicone. Such a membrane can reduce the mechanical stress exerted by the shell (2) on the pericardium (6) or the cardiac muscle (61). Likewise, such a membrane (21) can increase the biocompatibility of the shell (2). The membrane (21) can be applied to the inside or outside of the shell (2). The membrane (21) can also be produced by immersing the mesh- or grid-like shell (2) in an elastomer-containing liquid and then coating the mesh or grid. The openings of the mesh or grid can then be stretched by the membrane (21). A membrane (21) on the mesh or grid can also improve the abutment for an expandable unit (71, 72).For example, if an expandable unit (71, 72) is an inflatable chamber, a membrane (21) placed over, on, or within the mesh or grid can prevent parts of the chamber from being forced through the mesh or grid during expansion. The membrane (21) can also prevent excessive expansion of the shell (2), particularly during inflation of an inflatable chamber. A membrane (21) on a grid or mesh can ensure that expansion of an expandable unit located on the grid or mesh proceeds only in a direction inward from the mesh or grid. The membrane (21) does not impede the compressibility of the shell (2) when it is introduced into a feeding system.

[0037] The shell (2) and / or the membrane (21) can also comprise an active ingredient, for example, an antithrombotic agent, an antiproliferative agent, an anti-inflammatory agent, an antineoplastic agent, an antimitotic agent, an antimicrobial agent, a biofilm synthesis inhibitor, an antibiotic, an antibody, an anticoagulant, a cholesterol-lowering agent, a beta-blocker, or a combination thereof. Preferably, the active ingredient is in the form of a coating on the shell (2) and / or the membrane (21). The shell (2) and / or membrane (21) can also be coated with extracellular matrix proteins, in particular fibronectin or collagen. This can be advantageous if ingrowth of the shell (2) is desired.

[0038] The shell (2) contains at least one expandable unit (71, 72). Fig. Figure 3 shows a shell (2) into which a casing (7) with expandable units (71, 72) in the form of inflatable chambers is inserted. The expandable unit (71, 72) is supplied by a line (41) located in the cable (4). The expandable unit (71, 72) can be a hydraulic or a pneumatic chamber. The expandable unit (71, 72) can be attached directly to the shell (2) without a casing (7). The expandable unit (71, 72) can also be attached to a casing (7), and the casing (7) can be attached to the shell (2). The expandable unit (71, 72) can be designed to exert pressure on the heart (61). This pressure can be a permanent pressure or a periodically recurring pressure. The device according to the invention can include various types of expandable units (71, 72). The device can include at least one augmentation unit (71).The device can comprise at least one positioning unit (72). The augmentation unit (71) and / or the positioning unit (72) can be attached directly to the shell (2) or to a casing (7) that is inserted into the shell (2).

[0039] An augmentation unit (71) is a unit that can be periodically expanded and relaxed, thereby exerting pressure on the heart (61). This pressure is preferably exerted on the myocardium in areas beneath which a ventricle is located. By exerting pressure on a ventricle by the augmentation unit (71), the natural pumping action of the heart (61) is assisted or replaced, and the blood in the heart (61) is pumped out of the ventricle into the efferent artery. Pressure exerted by an augmentation unit (71) on a right ventricle causes the ejection of blood from the right ventricle into the pulmonary artery. Pressure exerted by an augmentation unit (71) on a left ventricle causes the ejection of blood from the left ventricle into the aorta. The positioning of the at least one augmentation unit (71) in the tray (2) is explained in more detail in a later section of the description.

[0040] A positioning unit (72) is a unit that can also be expanded. Preferably, a positioning unit is expanded more statically than periodically during operation of the device to support cardiac function. The positioning unit (72) can be expanded to fix the device to the heart and ensure a proper fit. A positioning unit (72) can also be used to respond to changes in the myocardium (e.g., myocardium shrinkage due to dehydration or myocardium expansion due to fluid intake). If the myocardium atrophies or builds up over time, a positioning unit can be further expanded and relaxed to ensure an optimal fit.The positioning unit (72) can, for example, also serve to ensure that the device does not lose contact with the heart wall during the duration of a heartbeat. Loss of contact can lead to shock loads between the heart muscle and the device and / or cause malfunctions of sensors (81) and / or electrodes (82). The positioning unit (72) can also, but not exclusively, counteract the pathologically induced, progressive expansion of the damaged heart muscle in patients with heart failure. The positioning of at least one positioning unit (72) in the tray (2) will be explained in more detail in a later section of the description.

[0041] An opening may be located at the lower end of the shell (2) through which the conductor (83) from the at least one sensor (81) or the at least one electrode (82) and / or the conductor (41) from the at least one expandable unit (71, 72) may pass. The opening may be located at the lower distal end of the shell (2). Alternatively, the opening may also be located on the side of the shell (2). This is shown in Fig. 3. An opening at the lower distal end of the shell (2) through which a cable (4), comprising all the conductors (4, 83), is guided. Alternatively, several separate cables may be present instead of a single cable (4). The multiple cables may be guided through one opening in the shell (2) or through several openings in the shell (2). A connector (90) is attached to the end of the cable (4), by means of which the at least one sensor (81) or the at least one electrode (82) and / or the at least one expandable unit (71, 72) can be connected to a power supply unit. Preferably, the shell (2) is installed within the pericardium (6). The cable (4) is then guided through the pericardium (6). The device according to the invention may include a pericardial closure (5). This can seal the opening in the pericardium (6) necessary for the cable passage.The pericardium (6) is a connective tissue sac that surrounds the heart (61) and allows the heart (61) free movement via a thin gliding layer. It contains a serous fluid, also called pericardial cerebrospinal fluid, which acts as a lubricant. To prevent this lubricant from leaking out of the pericardium (6) through the cable opening and to prevent other fluids or solids (such as cells, proteins, foreign bodies, etc.) from entering the pericardium (6), a pericardial closure (5) can be placed around the cable (4). The pericardial closure (5) seals the opening of the pericardium (6) to the cable (4). The pericardial closure (5) can comprise a first closure element with a first sealing lip and a second closure element with a second sealing lip. A cable (4) can be passed through a central lumen of the closure. The first sealing lip and / or the second sealing lip can seal the pericardial opening.An additional sealing element may be located in the central lumen, which can seal the cable (4) against the pericardial closure (5) and optionally also fix it in place. The first and second closure elements can be coupled. Preferably, the first and second closure elements can be secured by a mechanism. Possible mechanisms for securing the closure elements are screw mechanisms, clamping mechanisms, or a bayonet fitting. The first closure element and / or the second closure element can be expandable, preferably self-expanding. The pericardial closure (5) is described in more detail in a later section of this description.

[0042] Fig. 4a and Fig. Figure 4b shows a section through the heart (61) and part of the device for supporting the function of a heart (61) along line AA in Fig. 3. From the outside in, the following layers are shown: the shell (2) with a membrane (21), a sheath (7) with at least one expandable unit (71, 72), a sheath (80) with at least one sensor (81) or electrode (62), and the heart (60) in transverse section. Three augmentation units (71) and three positioning units (72) are shown as examples. Fig. Figure 4a shows the expandable units (71, 72) in their non-expanded state. Fig. Figure 4b shows the augmentation units (71) in an expanded state. The at least one expandable unit (71, 72) is located in a region adjacent to a heart chamber. Expansion of the at least one expandable unit (71, 72) can reduce the volume of the heart chamber, thus leading to the ejection of blood from the chamber. The at least one sensor (81) or the at least one electrode (82) is located at a point where at least one parameter of the heart (61) can be measured. An electrode (82) can be located at a point where the heart muscle can be stimulated. Fig. 4a and Fig. 4b shows, by way of example, four sensors (81) in the shell (80) and two electrodes (82) on the inside of the shell (80).

[0043] Fig. Figure 5 shows a delivery system (100) by means of which the device for supporting the function of a heart can be implanted. The delivery system (100) consists of a catheter (103) which has a lumen. Preferably, the catheter (103) is an elongated tubular element into which the device for supporting the function of a heart can be inserted in a compressed state. The cross-section of the catheter (103) and / or the lumen can be round, oval, or polygonal. The delivery system (100) can further comprise a guide wire (101) and / or a dilatation element. The dilatation element can be a soft, conical tip (102) with a shaft. The guide wire (101) can be advanced through a puncture in the chest wall (65) between the ribs (64) and the pericardium (6). The soft conical tip (102) may have a round, oval or polygonal lumen in the center.The soft, cone-shaped tip (102) can be slid over the guide wire (101), and the puncture can be dilated without injuring the epicardium. The distal portion of the catheter (103) of the delivery system (100) can be advanced through the dilated opening. A first closure element (51, 52) of the pericardial closure can be attached or otherwise secured to the distal end of the catheter (103). For example, the catheter (103) can be attached to a cone (55) located at the end of the first closure element (51, 52). Another embodiment, not shown, features a cone on the side of the catheter, onto which the first closure element can then be attached. The catheter (103) with the attached first closure element (51, 52) of the pericardial closure can be advanced over the shaft of the soft tip (102) and inserted into the pericardium (6).Alternatively, the catheter (103) and the first closure element (51, 52) of the pericardial closure device can be uncoupled components. In this case, only the catheter (103) is initially inserted into the pericardium (6), and the first closure element (51, 52) can then be advanced into the pericardium (6) via the catheter or deployed through the lumen of the catheter (103) within the pericardium (6). The first closure element (51, 52) can be a self-expanding closure element and can expand within the pericardium (6). Alternatively, a non-expandable portion (51) of the first closure element may contain a self-expanding sealing lip (52) or a sealing lip (52) that can be drawn upon insertion of the first closure element (51, 52) and expand within the pericardium (6). The first closure element (51, 52) can expand into a mushroom-shaped or umbrella-like shape.A second closure element (53, 54) can be inserted via or deployed through the catheter (103). For example, the second closure element (53, 54) can be moved via the catheter (103) of the delivery system (100) to the distal end of the delivery system (100) and can then be coupled to the first closure element (51, 52). The second closure element (53, 54) can be expandable or non-expandable. The second closure element (53, 54) can be coupled to the first closure element (51, 52). Preferably, the second closure element (51, 52) is self-expanding and can assume a mushroom-shaped or umbrella-like form in its expanded state. The second closure element (53, 54) can be secured to the first closure element (51, 52). Shown in . Fig. 5 is a screw mechanism. Other mechanisms for securing the locking elements (51, 52, 53, 54) include a clamping mechanism or a bayonet lock. After securing the locking elements (51, 52, 53, 54), the catheter (103) of the delivery system (100) may remain attached to the cone (55) of the first locking element (51) or remain within the lumen of the locking element (51, 52). After the guide wire (101) and the soft tip with shaft (102) have been withdrawn from the catheter, the shell containing the at least one sensor or the at least one electrode and / or the at least one expandable unit may be introduced through the lumen of the catheter (103). The shell is preferably self-expanding and, after expansion, at least partially encloses the heart (61). A connector or a cable with a connector may be located at the lower end of the shell.The supply unit can be attached directly to the tray or connected to the tray via a cable. After the tray has been inserted, the supply system (100) can be removed. For this purpose, a predetermined breaking point (104) can be located on the supply system (100) and / or on the catheter (103). Preferably, one or more predetermined breaking points (104) are located along a longitudinal axis of the supply system (100). The predetermined breaking point (104) can represent a predetermined breaking line. If the supply system (100) is broken open along a predetermined breaking point (103), the supply system (100) can be separated, unrolled, and removed. The supply system (100) can also include gripping elements (105) by means of which a force can be applied to the supply system (100). Preferably, the gripping elements (105) can exert a force directed laterally away from the catheter (103) of the delivery system (100), which is suitable to break the predetermined breaking point (104).

[0044] Fig. Figure 6 shows a step in the implantation of the device according to the invention. After the first closure element (51, 52) has assumed its expanded shape in the pericardium (6), the shell (2), which is preferably self-expanding, can be guided through the lumen of the catheter (103) of the delivery system and the lumen of the first closure element (51). Once at least part of the shell (2) with the at least one sensor or the at least one electrode and / or the at least one expandable unit is located in the pericardium (6), the expansion of the shell (2) begins. (Illustrated in...) Fig. 6 is also the second closure element (58, 59) before it is coupled to the first closure element (51, 52). In this embodiment, the second closure element (58, 59) is an annular element (58), e.g., a nut, on the distal side of which a sealing washer (59) may be attached. The second closure element (58, 59) may be expandable or non-expandable. The second closure element (58, 59) can be moved along the catheter (103). In this embodiment, the first (51, 52) and the second closure element (58, 59) have threaded sections that can be screwed together.

[0045] Fig. Figure 7 shows a step in the implantation of the device according to the invention. In this embodiment, the first closure element (51, 52) is coupled to the second closure element (53). This allows the pericardium (6) to be sealed. The expandable shell (2) is partially located within the pericardium (6) and can be expanded. Fig. Figure 7 shows markings (22, 23, 24) applied to the tray (2). The device according to the invention generally includes at least one marking (22, 23, 24) that facilitates correct placement of the tray (2). The marking (22, 23, 24) can be an optical marking, in particular a color marking. The marking (22, 23, 24) can be a phosphorescent or fluorescent marking, which facilitates its perception in a dark environment. Such environments can be in the operating room itself and can be caused, among other things, by shadows. Such environments can also be inside a patient's body. The marking (22, 23, 24) can be made of a material that can be visualized using imaging techniques. Suitable imaging techniques include X-ray imaging, CT imaging, and MRI.The marking (22, 23, 24) can be formed from a material with a higher radiopacity than the material of adjacent regions. The marking (22, 23, 24) can be in the form of a point, a circle, an oval, a polygon, or a letter. Other shapes can be areas created by connecting points. For example, the shape can be a crescent moon or a star. The marking (22, 23, 24) can be placed on the shell (2) or on a shell. The marking can be in the form of a line. The line can originate from an upper edge of the shell (2). The line can extend from an upper edge of the shell (2) to a point at the lower tip of the shell (2). The line can extend perpendicularly from the upper edge of the shell to the lower tip of the shell (2).The starting point of the line at the upper edge of the shell (2) can be located at a point that, in the implanted state, is near or at the level of the septum of the heart. The marker (22, 23, 24) can be located at intersection points of the mesh or grid. If the shell (2) consists of a shell shell with holes formed in it, the marker (22, 23, 24) can be incorporated into the shell shell. For example, a hole with a predefined shape can be made, which then serves as the marker (22, 23, 24).

[0046] The delivery system and / or the catheter (103) of the delivery system may include one or more markings (106). A marking (106) on a delivery system may be shaped like a marking on a tray. The marking (106) may be in the form of a dot or a line. A line marking (106) may describe at least part of the circumference of the delivery system. A line marking (106) may be a longitudinal line along an axis of the delivery system. A line marking (106) may be a straight line or a meandering line. A line marking (106) may be a diagonal line on a catheter (103) of a delivery system. A marking (103) may facilitate the orientation of the delivery system during implantation. A marking (103) on or at the delivery system may be aligned with a line on or at the medical implant.For example, the medical implant may be a device to support the function of a heart that can be compressed. In a compressed state, the device can be inserted into a delivery system. One or more markings (22, 23, 24) on or at the device can be aligned with one or more markings (106) on or at the delivery system. Such markings (22, 23, 24, 106) facilitate the orientation of a medical implant. Markings (22, 23, 24) may also be located along an axis of a medical implant. Such markings (22, 23, 24) can be helpful in monitoring the progress of the delivery of a medical implant from a delivery system. The delivery system and / or a catheter (103) may be made of a transparent material that allows the medical implant to be perceived during insertion.

[0047] Fig. Figure 8 shows a step in the implantation of the device according to the invention. In this example, the first closure element (1, 52) and the second closure element (53) of the pericardial closure are coupled together. The device for supporting the function of a heart has already been partially deployed from the delivery system. A self-expanding shell (2) is shown. In this embodiment, the shell (2) is formed from a wire mesh that has loops (26, 28) at the upper and / or lower edge of the shell (2). The shell (2) can also be formed from a grid structure and can then have struts in the form of brackets at the upper and / or lower edge of the shell (2).If the bowl (2) is formed from a shell in which holes have been formed, the bowl (2) can be designed at the upper edge and / or the lower edge such that at least one bail is located at the upper edge and / or at the lower edge of the bowl (2). The in . Fig. The shell (2) shown in Figure 8 comprises a cover (80) inserted into the shell (2). A cover with at least one expandable unit can be located between the cover (80) and the shell (2). One or both covers can be attached to the loops (26, 28) or brackets of the shell (2). In particular, a cover can be hooked onto the loops (26, 28) or brackets of the shell (2). In such a case, the cover (80) can have at least one pocket (27) that can be slipped over at least one loop (26, 28) or at least one bracket. Another embodiment can comprise a cover (80) that is turned inside out at its upper edge and / or lower edge. This turning inside out can form a pocket (27) encircling all or part of the cover (80), which can be hooked onto the upper edge and / or lower edge of the shell (2). Fig. Figure 8 shows that the bowl (2) has several markings (22, 23, 24, 25). As already described, these markings (22, 23, 24, 25) can take on different shapes or positions. In this case, the markings (22, 23, 24, 25) are located on an upper edge and at the lower tip of the bowl (2).

[0048] Fig. Figures 9a-c show different views of a pericardial closure device (5). The pericardial closure device (5) serves to prevent the loss of pericardial fluid or to allow the administration of artificial pericardial fluid, including the addition of medications or other therapeutic agents. Preventing pericardial fluid loss also helps prevent adhesions between the system and the epicardium. The pericardial closure device (5) generally consists of a first closure element (51) and a second closure element (52). The first closure element (51) has a central lumen, and the second closure element (53) also has a central lumen. The first closure element (51) can be coupled to the second closure element (53). After coupling the first closure element (51) to the second closure element (52), the coupled pericardial closure device (5) has a lumen extending through the pericardial closure device (5).The lumen can be formed exclusively by the central lumen of the first closure element (51), or it can be formed exclusively by the central lumen of the second closure element (53). In another embodiment, the lumen can also be formed by the two lumens of the two coupled closure elements (51, 53). A sealing sleeve, an O-ring, a labyrinth seal, or another sealing element (56) can be located in the lumen. A sealing element (56) in the lumen of the pericardial closure can seal the pericardial closure (5) against an object protruding through it. For example, a cable can be passed through the pericardial closure (5), which then seals it against the closure. A sealing element (56) in the lumen can serve not only to seal but also to secure an object protruding through the lumen of the pericardial closure.The sealing element (56) can be attached to both closure elements (51, 53) or only to one of the two closure elements (51, 53).

[0049] The first locking element (51) can be secured to the second locking element (53) by means of a mechanism. A mechanism for securing a first locking element (51) to a second locking element (53) can comprise a screw mechanism or a clamping mechanism. A mechanism for securing a first locking element (51) to a second locking element (53) can also comprise a bayonet fitting. The first locking element (51) and the second locking element (53) can be made of the same material or of different materials. Suitable materials for the first locking element (51) and / or the second locking element (53) include plastics, metals, ceramics, or combinations thereof.

[0050] A first sealing lip (52) can be attached to the first closure element (51). The first sealing lip (52) can be part of the first closure element (51) or it can be attached to the first closure element (51). A second sealing lip (54) can be attached to the second closure element (53). The second sealing lip (54) can be part of the second closure element (53) or it can be attached to the second closure element (53). The first sealing lip (52) and the second sealing lip (54) can be made of the same material or of different materials. One or both sealing lips (52, 54) can be part of the respective closure element (51, 53) and be made of the same material as the associated closure element (51, 53). The first sealing lip (52) and / or the second sealing lip (54) can be made of plastic (preferably an elastomer), rubber, silicone, latex, or a combination thereof.The first sealing lip (52) and / or the second sealing lip (54) can be disc-shaped. The first sealing lip (52) and / or the second sealing lip (54) can have a concave or convex curve. Curved sealing lips (52, 54) can adapt better to the anatomical conditions. The pericardium has a convex shape in the region of the apex of the heart. By having the sealing lips (52, 54) curve in the shape of the anatomically present pericardium, an improved anatomical fit of the pericardial closure (5) can be achieved. Improved sealing properties can also be achieved with curved sealing lips (52, 54). The first sealing lip (52) and / or the second sealing lip (54) can have reinforcements. With increasing radial distance from the lumen of the pericardial closure outwards, the first sealing lip (52) and / or the second sealing lip (54) can exhibit increased flexibility.Increased flexibility in the edge regions of a sealing lip (52, 54) can improve the sealing properties of the sealing lip (52, 54) and also the anatomically correct positioning of the sealing lip (52, 54). Increased flexibility in the edge regions of a sealing lip (52, 54) can be achieved through the choice of material. Each of the sealing lips (52, 54) can consist of one material or of several materials. Reinforcements in a sealing lip (52, 54) can be concentric or radial. Reinforcements can be achieved by varying material thicknesses or by incorporating a reinforcing material. The reinforcing material can be the same material as the base material of the sealing lip (52, 54) that has been transformed into a different form of the material. Alternatively, regions that should not be reinforced can be weakened by transforming the material of the sealing lip (52, 54) into a weaker form of the material.A weakening of the material can be caused by exposure to energetic radiation, such as heat. Strengthening of the material can also be achieved by applying material, which can be the same material as the base material of the sealing lip (52, 54) or a different material. Suitable materials for reinforcing parts of a sealing lip (52, 54) are metals, ceramics, rubber, and / or a combination thereof.

[0051] One of the two closure elements (51, 53) may have a coupling mechanism that allows the closure element (51, 53) to be coupled to the delivery system or a catheter of the delivery system. The coupling mechanism may, for example, consist of a cone (55) located on the first closure element (51) onto which the delivery system or a catheter of a delivery system can be clamped. The clamping effect can be achieved, for example, by having a diameter of the cone (55) that is larger than the luminal diameter of the delivery system. The coupling mechanism for coupling the pericardial closure (5) to the delivery system may also be located on the second closure element (53). Alternatively, the coupling mechanism may be a separate component located next to the closure elements (51, 53) and connect the delivery system to one of the two closure elements (51, 53) of the pericardial closure (5).Other embodiments of the coupling mechanism include, among others, a non-conical (e.g., cylindrical) extension on one of the closure elements (51, 53) onto which the delivery system can be applied or glued, or an embodiment in which the catheter of the delivery system and a closure element form a single integral part. In the latter embodiment, after successful insertion and securing of the pericardial closure (5), the catheter can be separated from the closure element (51, 53) of the pericardial closure (5) by means of a predetermined breaking point.

[0052] One or both locking elements (51, 53) may have engagement elements (57). These engagement elements (57) can be used to exert a force on one or both locking elements (51, 53) suitable for coupling and / or securing the locking elements (51, 53). Engagement elements (57) on one or both locking elements (51, 53) can be holes, indentations, or protrusions. The engagement elements (57) can be arranged around the locking element (51, 53) at equal intervals. The circumferential distance between the engagement elements (57) can also vary. Fig. Figures 9a-c show six engagement elements (57) spaced uniformly around each other. The six engagement elements (57) are mounted on the annular closure element (53) at an angular interval of approximately 60°. For two, three, four, five, six, eight, or more uniformly arranged engagement elements (57), the angular interval can be 180°, 120°, 90°, 72°, 60°, 45°, or less, respectively. The engagement elements (57) can also be arranged irregularly.

[0053] Fig. Figure 10 shows a pericardial closure (5) and a tool (11) for securing a pericardial closure (5). The in Fig. The pericardial closure shown in 10 (5) is essentially the same as that shown in Fig. The closure shown in Figure 9 corresponds to the tool (11) shown as an elongated, tubular tool. At the distal end of the tool (11) are elements (111) which can be engaged, at least partially, with the engagement elements (57) of a closure element (53). In the Fig. In the embodiment shown in Figure 10, the tubular tool (11) has six inwardly pointing projections (111) at its distal end, which can engage with the six engagement elements (57) of the closure element (53), in this case six indentations on the closure element (53). The tool (11) has essentially the same number of elements (11) that are complementary to the engagement elements (57) of the closure element (53). The in Fig. The tool (11) shown in Figure 10 is a tubular tool consisting of a fully circumferential tube. The tubular element of the tool (11) can also be a half-tube, a quarter-tube, or a third-tube. In the extreme case, instead of the tube, only a handle or several handles can be attached to a distal ring-shaped tool. A handle can extend longitudinally from the ring-shaped tool. A handle can also extend laterally away from a longitudinal axis of the tool. Other embodiments of the tool (11), not shown, can be in the form of a modified ring wrench or a modified open-end wrench.

[0054] Fig. Figure 11 shows a connector system consisting of two connector parts (90, 92). The device for supporting the function of a heart consists of a shell with at least one sensor or at least one electrode and / or at least one expandable unit, wherein the at least one sensor or electrode and / or the at least one expandable unit is connected to a power supply unit. The at least one sensor or the at least one electrode and / or the at least one expandable unit can be connected directly to the power supply unit. The at least one sensor or the at least one electrode and / or the at least one expandable unit can be connected to the power supply unit via a cable (4).The at least one sensor or at least one electrode and / or at least one expandable unit can be directly connected to the power supply unit via the cable (4), or the at least one sensor or at least one electrode and / or at least one expandable unit can be connected to the power supply unit. The power supply unit can include a connector part (92). The connector part (92) can be directly attached to the power supply unit. The connector part (92) can be connected to the power supply unit via a cable (4). The at least one sensor or at least one electrode and / or at least one expandable unit can include a cable (4). A connector part (90) can be located at the end of the cable (4). The connector part (90) at the end of the cable of the at least one sensor or at least one electrode and / or at least one expandable unit can be coupled to the connector part (92) of the power supply unit.The connector part (9) of the sensor or electrode and / or the at least one expandable unit can be a male or a female connector part. A female connector part on the side of the sensor or electrode and / or the at least one expandable unit can be advantageous because, unlike the male connector part, the female connector part does not include any pins (951) or other connections that protrude and can therefore break. If it is necessary to replace the power supply unit, the connector system must be disconnected and a new power supply unit coupled into the connector part (90) of the sensor or electrode and / or the at least one expandable unit. This can result in the breakage of pins (951) or other connections.If these pins (951) or connections are located on a male connector part on the side of the shell with the at least one sensor or the at least one electrode and / or the at least one expandable unit, replacement of the shell may be necessary. A female connector part on the side of the shell with the at least one sensor or the at least one electrode and / or the at least one expandable unit can be advantageous, since breakage of pins (951) or other connections on a female connector part cannot occur. The connector system (90, 92) generally consists of two connector parts. The device according to the invention comprises a connector system with at least one connection for a pneumatic line and at least one connection for an electrical line. Fig. The connector system (90, 92) shown in Figure 11 is a connector system comprising connections for supplying the at least one sensor or the at least one electrode and the at least one expandable unit. The number of connections depends on how many sensors or electrodes and how many expandable units are used, whereby the number does not necessarily correlate directly with the number of sensors or electrodes and / or the number of expandable units. Branching of lines is possible on both sides of the connector system (90, 92), and a pneumatic or hydraulic line can supply one, two, three, four, five, six, or more fillable chambers. The filling of the multiple chambers by one line does not have to be parallel; it can also be carried out individually by means of controllable valves.Similarly, a single electrical conductor in the cable can be used for multiple sensors or electrodes, and switches can individually control circuits. This is in... Fig. The connector system shown in Figure 11 (90, 92) comprises four hydraulic or pneumatic connections (93, 94) and one connection for electrical lines (95, 96). The connector system shown in Figure 11 comprises four hydraulic or pneumatic connections (93, 94) and one connection for electrical lines (95, 96). Fig. The connector shown in Figure 11 for electrical lines (95, 96) has 16 connection elements in the form of pins (951) and pin sockets (961). A connector system can have more or fewer connections for electrical lines (95, 96) and / or pneumatic or hydraulic lines (93, 94). There can be one, two, three, four, five, six, seven, eight, nine, or ten connections for pneumatic or hydraulic lines (93, 94). There can be one, two, three, four, five, six, seven, eight, nine, ten, twelve, fourteen, sixteen, twenty, or more connections for electrical lines (95, 96). There can be one, two, three, four, five, six, seven, eight, nine, ten, twelve, fourteen, sixteen, twenty or more connection elements in the form of pins (951) and pin sockets (961) within an electrical connection for electrical conductors (95, 96).The number of connection elements in the form of pins (951) and pin sockets (961) is identical for each pair of electrical connections (95, 96). Each of the connections (93, 94, 95, 96) in one or both of the connector parts of the connector system (90, 92) can have its own seal (931, 952). The seal (931, 952) of the individual connections (93, 94, 95, 96) can be a sealing strip or a sealing ring. The connector system (90, 92) can have an additional or only seal inside the connector system (973) or around the connector system. A seal over the connector system can be a sealing strip or a sealing ring. The connector parts (90, 92) can be coupled together to form the connector system (90, 92). The connector parts (90, 92) can also have a guide lug (972) and a guide groove (974).The guide lug (972) and guide groove (974) prevent incorrect coupling of the two connector parts and / or twisting of the connector parts during the coupling process. Two, three, or more guide lugs (972) and guide grooves (974) may be present. In the case of two or more guide lugs (974) and guide grooves (974), unequal distances between the individual guide lugs (974) and guide grooves (974) are used. The coupled connector parts (90, 92) may also be secured by a mechanism (971). Such a mechanism (971) may be a screw mechanism, a clamping mechanism, or a bayonet lock. A mechanism for securing the coupled connector system (90, 92) may also be a cap nut, clamp, latch, or snap lock attached to the outside of the connector system.Securing the connector system (90, 92) is advantageous because an accidental or random partial or complete opening of the connector system (90, 92) could interrupt the supply to the at least one sensor or the at least one electrode and / or the at least one expandable unit.

[0055] Fig. Figure 12 shows a model for creating a coordinate system. Creating a coordinate system can facilitate the fabrication of a device to support the function of a heart, since the position for the at least one sensor or electrode and / or the at least one expandable unit and / or the at least one marker can be precisely defined. Fig. Figure 12a shows a heart (61) with anatomical landmarks. The heart (61) is depicted with the aortic arch (AO) originating from the left ventricle (LV) (with the branching head, neck, and subclavian arteries (TR, CL, SCL)) and the pulmonary artery (PU) originating from the right ventricle (RV). Parts of the inferior vena cava (IVC) and the superior vena cava (SVC) are also shown. The dashed line (601) represents the level of the valve plane. By dropping a perpendicular (603) from this plane (601) through the most distal point of the apex of the heart, the point (604) of the apex is defined. The device according to the invention consists of a shell into which a sheath with at least one sensor or electrode and / or a sheath with at least one expandable unit can be inserted.The dimensions of the shell and / or the casing can be designed such that the upper edge of the casing (602) runs parallel to the valve plane with a downward offset from the valve plane in the direction of the apex of the heart of 1 mm to 30 mm, 3 mm to 20 mm, 5 mm to 10 mm, preferably 5 mm. The upper edge of the shell is in . Fig. Figure 12a shows the line (602). The lower edge of the shell (605) and / or cover can be parallel to the valve plane at a distance from the most distal point (604) of 1 mm to 30 mm, 3 mm to 20 mm, 5 mm to 10 mm, preferably 5 mm. Fig. 12b shows a section plane BB along the in Fig. 12a line (602), i.e., along the line corresponding to the upper edge of the bowl. In Fig. Figure 12b shows the right ventricle (RV) and the left ventricle (LV), the heart wall, and the septum separating the ventricles. Points (608) and (609) are defined as the intersection points of the midlines of the heart wall and the septum. Point (608) is also referred to as the anterior intersection point of the midlines of the heart wall and the septum. Point (609) is also referred to as the posterior intersection point of the midlines of the heart wall and the septum. The midpoint of a line connecting points (608) and (609) is defined as point (607). A polar coordinate system can be defined using these points. The z-axis (606) of the polar coordinate system is defined as the connecting line of the most distal point (604) with the midpoint (607) of the line connecting the points (608) with (609).The circumferential direction of the coordinate system is indicated by the reference symbol (610) and is defined as an angular measure φ, where a line extending radially from the z-axis (606) through the anterior intersection point (608) is defined as φ = 0°.

[0056] Fig. 13 shows a shell and / or casing with the above in connection with Fig. 12 described coordinate system. Fig. Figure 13a shows a 3D model (611) of a shell or shell with the z-axis (606) passing through the most distal point (604) and the midpoint (607) of the line connecting points (608) and (609). Points (608) and (609) are the anterior and posterior intersection points, respectively, of the midlines of the heart wall and the septal wall, with the φ = 0° line passing through point (608). The dashed line connecting points (608) and (609) along an outer circumference of the shell or shell represents the position of the heart septum projected onto the shell / shell. At the top of the shell or shell, angular measurements are shown in 30° increments, increasing counterclockwise from the top. Longitudinal lines (613) projected onto the shell / shell run along these angle measurements up to the apex of the heart (604). The angle of φ = 360° then corresponds to the angle of φ = 0°.Contour lines (614) are drawn at intervals of 15 mm. The contour lines (614) and planes run perpendicular to the z-axis (606). The dotted-dashed line (615) represents a cutting line along which the 3D shape (611) can be cut and then unrolled. Fig. 13b shows an unrolled shell or casing (612) extending along line (615) in Fig. 13a was cut and then rolled out. The in Fig. The positions (608, 609) and lines (613, 614, 615, 616) shown in Figure 13b represent the same positions and lines that are shown in Fig. 13a are shown.

[0057] Fig. Figure 14 shows a shell (7) with at least one expandable unit (71, 72). The 3D shape of the shell (7) in Fig. 14a is comparable to that in connection with Fig. Figure 13a explains the 3D model and shows a coordinate system as described above. The shell (7) can at least partially enclose a heart. The shell (7) can at least partially have the shape of a heart. The shell (7) can have a similar shape to the shell. The shell can be inserted into the shell. The shell can be made of plastic, polymer, rubber, latex, silicone, or polyurethane.

[0058] In Fig. 14a the shell (7) with at least one expandable unit (71, 72) is represented as a shell (7) with a plurality of chambers. Fig. Figure 14b shows a 2D unrolling of the 3D model from Fig. 14a. The in Fig. The unwinding shown in 14b essentially corresponds to that in connection with Fig. Section 13b explained the unrolling of a 3D model. Unlike in Fig. 13a is the 3D model in Fig. 14a rotated in such a way as to allow a view from above into the shell (7). In the Fig. 14a and Fig. Figure 14b shows four expandable units (71, 72) as examples, of which three are augmentation units (71) and one is a positioning unit (72). The expandable units (71, 72) may be structurally similar, but as described above, they may serve different purposes.

[0059] In general, an augmentation unit (71) can be periodically expanded and relaxed to exert pressure on the heart. This pressure is preferentially applied to areas of the myocardium beneath a ventricle. By exerting pressure on a ventricle with the augmentation unit (71), the heart's natural pumping action is assisted or replaced, and blood is pumped from the ventricle into the efferent artery. Pressure exerted by an augmentation unit (71) on a right ventricle causes blood to be ejected from the right ventricle into the pulmonary artery. Pressure exerted by an augmentation unit (71) on a left ventricle causes blood to be ejected from the left ventricle into the aorta.

[0060] In Fig. Figure 14 shows three augmentation units (71) located in areas at the upper edge of the shell (7). In this example, each augmentation unit (71) is supplied by its own line (41). In the case of augmentation units (71) in the form of inflatable chambers, the lines (41) are preferably pneumatic or hydraulic. Other embodiments include one, two, three, four, five, six, or more augmentation units (71) supplied by one, two, three, four, five, six, or more lines (41). The at least one line (41) can be made of plastic, polymer, rubber, latex, silicone, or polyurethane. The at least one line (41) can run above, beside, or below at least one augmentation unit (71). The at least one line (41) can preferably run below a positioning unit (72) to prevent pressure points between the at least one line (41) and the heart wall.At least one line (41) can also run over or next to a positioning unit (72).

[0061] The in Fig. The 14 augmentation units (71) A1, A2, and A3 shown are located at an area on the upper edge of the shell (7) and are each supplied by their own line (41). Augmentation units (71) A1 and A2 can be positioned, as in this embodiment, to support a left ventricle. Augmentation unit (71) A3 is positioned to support a right ventricle. The individual augmentation units (71) A1, A2, and A3 can be expanded independently. Augmentation units (71) A1 and A2 can be used to support left ventricular failure. Augmentation unit (71) A3 can be used to support right ventricular failure. Augmentation units (71) A1, A2, and A3 can be used to support bilateral ventricular failure. The augmentation units (71) can be expanded synchronously or asynchronously.Preferably, the expansion of the augmentation units (71) can be coordinated to support a natural pumping function of the heart.

[0062] A positioning unit (72) is a unit that can also be expanded. Preferably, a positioning unit is expanded more statically than periodically during operation of the device to support the function of a heart. The positioning unit (72) can be expanded to fix the device to the heart and to optimize the device's fit. A positioning unit (72) can also be used to respond to changes in the heart muscle. If the heart muscle atrophies or thickens, a positioning unit (72) can be further expanded or relaxed to ensure an optimal fit.

[0063] In Fig. Figure 14 shows a positioning unit (72) that essentially fills the spaces between the three augmentation units (71) on the shell (7). The positioning unit (72) can be located laterally 1 mm, 3 mm, 5 mm, 10 mm, 20 mm, 30 mm, 40 mm, or more from one or more augmentation units (71). The positioning unit (72) can be supplied by its own line (41), or, in the case of a fluid-fillable chamber, by its own pneumatic or hydraulic line. Other embodiments include one, two, three, four, five, six, or more positioning units (72) supplied by one, two, three, four, five, six, or more pneumatic or hydraulic lines (41). The line (41) can be made of plastic, polymer, rubber, latex, silicone, or polyurethane.At least one line (41) for supplying the positioning unit (72) can run under the positioning unit (72). The one in . Fig. Figure 14 shows a positioning unit (72) that fills areas between the augmentation units (71). The positioning unit (72) shown has extensions that project into the spaces between the augmentation units (71).

[0064] Fig. Figure 15 shows an expandable unit (71, 72) in the form of a chamber (710). The chamber shown is a bellows-shaped chamber (710). A bellows-shaped chamber (710) has at least one section in the form of a bellows. Preferably, it is a bellows consisting of one, two, three, four, five, six, seven, or more folds. A fold can be defined as an outwardly directed crease (711). A fold can also be defined as an inwardly directed crease (712). One, several, or all creases (711, 712) can be reinforced. Reinforcing a crease (711, 712) is advantageous because the crease (711, 712) may be subjected to increased stresses due to the expansion and relaxation of the chamber (710). Reinforcing one or more bend edges (711, 712) can reduce or prevent material fatigue along at least one bend edge (711, 712).Reinforcement of a bend edge (711, 712) can be achieved by increasing the wall thickness of the material at the bend edge (711, 712). Reinforcement of a bend edge (711, 712) can also be achieved by applying additional material, wherein the applied material can be the same material as the underlying material, or wherein the applied material can be a different material than the underlying material. A chamber (710) can have a top surface (713), a bottom surface, and a side surface, wherein the side surface is preferably bellows-shaped. The top surface (713) and / or the bottom surface can be oval, circular, elliptical, or polygonal. The top surface (713) can have a different shape than the bottom surface.

[0065] A bellows-shaped chamber (710) can be inserted into a shell as described above. The chamber (710) can be attached or fixed directly within the shell. The chamber (710) can be attached to structural elements of the shell, such as a wire of a wire mesh, a strut of a lattice, or a structure on a shell surface. The chamber (710) can be attached at the intersection points of a mesh or lattice. The shell can be covered with a membrane as described above. In these cases, the chamber (710) can also be attached to the membrane. The membrane can also form the underside of the chamber (710).

[0066] The bellows-shaped chamber (710) can also be attached to a shell (7). Several bellows-shaped chambers (710) can be attached to a shell (7). The shell (7) can be at least partially heart-shaped. The shell (7) can have a shape similar to the shell. The shell (7) can be inserted into the shell. The shell (7) can be attached and / or fixed in the shell. In addition to one or more augmentation units, such as one or more bellows-shaped chambers (710), the shell (7) can also have one or more positioning units. The underside of the chamber (710) can be made of the same material as the shell (7). The shell (7) can be part of the chamber (710). The shell (7) can form the underside of the chamber. In such cases, only the side surfaces, which can be bellows-shaped, are applied to a shell (7). Additionally, a top surface (713) can be attached. The top surface (713) can also be a shell.Embodiments consist of two shells (7), wherein the shells (7) form the top and bottom of the chambers, and side surfaces are formed between the shells. In this case, side surfaces can also be formed by joining, in particular by welding or bonding, the two shells. The shells (7) can be joined together, in particular by welding or bonding, to form a chamber. The at least one conduit that supplies the chamber can, similarly to the chamber, be formed at least partially by joining the two shells (7), in particular by welding or bonding them. One or more sensors or one or more electrodes can be located on one or both of the two shells (7).

[0067] The shell (7) with the at least one expandable unit can have at least one pocket at its upper edge and / or lower edge. The at least one pocket can be at least partially fitted over a structural form of a shell. For example, the pocket can be at least partially fitted over a loop of a wire mesh or a bracket of a lattice structure.

[0068] The shell (7) with the at least one expandable unit can contain an active ingredient. For example, the shell (7) can contain an antithrombotic agent, an antiproliferative agent, an anti-inflammatory agent, an antineoplastic agent, an antimitotic agent, an antimicrobial agent, a biofilm synthesis inhibitor, an antibiotic, an antibody, an anticoagulant, a cholesterol-lowering agent, a beta-blocker, or a combination thereof. Preferably, the active ingredient is in the form of a coating on the shell (7). The shell (7) can also be coated with extracellular matrix proteins, in particular fibronectin or collagen.

[0069] Fig. Figure 16 shows a shell (80) with at least one sensor (81) and / or at least one electrode (82). The 3D shape of the shell (80) in Fig. 16a is comparable to the one in Fig. Figure 13a illustrates the 3D model and shows a coordinate system as described above. The shell (80) can at least partially enclose a heart. The shell (80) can at least partially have the shape of a heart. The shell (80) can have a similar shape to the shell. The shell (80) can be inserted into the shell. The shell (80) can be made of plastic, polymer, rubber, latex, silicone, or polyurethane. The shell (80) can have a thickness of 0.1 mm to 1 mm, preferably 0.2 mm to 0.5 mm. The shell (80), with the at least one sensor (81) and / or at least one electrode (82), can be pressed against the heart muscle by the shell with the expandable units. The shell (80) can be coated, in particular with a lubricant, which reduces the friction between the heart muscle and the shell (80) with the at least one sensor (81) and / or the at least one electrode (82).A coating, in particular a coating with a lubricant, can also be present between the casing (80) with the at least one sensor (81) and / or the at least one electrode (82) and the casing with the at least one expandable unit. The at least one sensor (81) and / or the at least one electrode (82) can be incorporated, cast, or welded into the casing (80), or attached, glued, or sewn onto the casing (80). The at least one sensor (81) and / or the at least one electrode (82) can be provided with reinforcements that prevent buckling during compression of the device.

[0070] In Fig. 16a shows the shell (80) with at least one sensor (81) and / or at least one electrode (82) as a shell (80) with a plurality of sensors (81) and electrodes (82). Fig. Figure 16b shows a 2D unrolling of the 3D model from Fig. 16a. The in Fig. The unwinding shown in 16b essentially corresponds to that in connection with Fig. Section 13b explained the unrolling of a 3D model. Unlike in Fig. 13a is the 3D model in Fig. 16a rotated in such a way as to allow a view from above into the shell (80). In the Fig. 16a and Fig. Figure 16b shows eight sensors (81) or electrodes (82) by way of example. Other embodiments may include one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve or more sensors (81) and / or electrodes (82). The shell (80) with at least one sensor (81) or at least one electrode (82) may be a network of sensors (81) or electrodes (82). The network of sensors (81) or electrodes (82) may at least partially enclose the heart. The sensors (81) or electrodes (82) in the network of sensors (81) or electrodes (82) may be interconnected. The shell (80) may serve as a support for the network of sensors (81) or electrodes (82). The network of sensors (81) or electrodes (82) may also be only partially mounted on a shell (80). The network of sensors (81) or electrodes (82) can also be placed in a shell as described above without a casing (80).

[0071] The at least one sensor (81) or the at least one electrode (82) can determine a physical or chemical property of its environment. The property can be measured qualitatively or quantitatively. The sensor (81) can be an active sensor or a passive sensor. The at least one sensor (81) can measure at least one parameter of the heart. The at least one sensor (81) can be suitable for determining the heart rate, ventricular pressure, systolic blood pressure, or diastolic blood pressure. The sensor (81) can be suitable for measuring the pressure exerted on a surface by an expandable unit, the pH value, the electrical resistance, the osmolarity of a solution, or the flow rate through a vessel. The at least one sensor can also be used as an electrode.

[0072] The at least one electrode (82) can be suitable for stimulating areas of the heart and / or measuring the action potential in the heart muscle during the excitation process. In particular, the at least one electrode (82) can be suitable for stimulating the heart muscle by means of electrical impulses. Electrical stimulation can induce a heart muscle to contract. The at least one electrode (82) can be a pacemaker electrode. The electrode (82) can be an extracardiac stimulation electrode. The heart muscle can be stimulated with an electrode (82) before, during, or after assistance of the heart's pumping function by a shell containing at least one expandable unit. The expansion of an expandable unit can occur before, during, or after stimulation with an electrode (82).The device for supporting the function of a heart can be operated either with at least one expandable unit or by stimulation with at least one electrode (82). Simultaneous operation of the at least one expandable unit and the at least one electrode (82) can be synchronous or asynchronous. The at least one electrode can also be used as a sensor.

[0073] The at least one sensor (81) or the at least one electrode (82) can be attached to the casing (80). The at least one sensor (81) or the at least one electrode (82) can be glued, sewn, or welded to the casing (80). The at least one sensor (81) or the at least one electrode (82) can be installed in the casing (80), preferably welded in. The at least one sensor (81) or the at least one electrode (82) can be connected to a power supply unit via a cable (84). The data acquired by the sensor (81) or the electrode (82) can also be transmitted wirelessly via a radio technology such as Bluetooth.

[0074] The contacts of the electrodes or sensors, or the entire casing, can be coated with a substance that increases or improves conductivity. For example, a graphite coating on the contacts can increase their conductivity. Example 1

[0075] Fig. Figure 17 shows an embodiment of a shell (7) with at least one expandable unit (71, 72). Illustrated in Fig. 17 is a like in connection with Fig. Figure 13 describes a 2D unrolling of a 3D model. The illustrated shell of this embodiment comprises three augmentation units (71) (A1, A2, A3) and one positioning unit (72) (P). In this embodiment, augmentation units A1 and A2 each occupy an area of ​​28.6 cm² on the shell. The area occupied by augmentation unit A3 is 34.5 cm² in this example. In this embodiment, the positioning unit (72) (P) occupies an area of ​​114.5 cm². Under normal conditions, the nominal expansion of the positioning unit (P) is 5 mm, i.e., the positioning unit is partially expanded and has a thickness of 5 mm. The positioning unit can be a chamber that can be filled and emptied with a fluid. The thickness of the positioning unit can therefore be between 1 mm and 10 mm, preferably between 3 mm and 7 mm.By changing the thickness of the positioning unit (72) (P), an increase or decrease in the size of the heart can be compensated for, and the correct positioning of the shell (7) and / or casing is essentially maintained. In this example, augmentation units A1 and A2 can be expanded by approximately 1.9 cm in thickness to apply pressure to a heart chamber, in this case, the left ventricle. The effective volume expansion of augmentation units A1 and A2 is 40 ml in this example. The effective volume expansion of augmentation unit A3 is 50 ml in this case, resulting in an effective thickness expansion of 1.45 cm. Each corner of an augmentation unit can be defined by the coordinates of its vertices. The coordinate system was developed in connection with [reference missing]. Fig. 13 explained.

[0076] In this example, the augmentation unit A1 extends from vertex 1 (φ = 359°; z = 100) via vertex 2 (φ = 48°; z = 85) and vertex 3 (φ = 48°; z = 40) to vertex 4 (φ = 328°; z = 56) and, in the implanted state, lies against the left ventricle. The connection between vertex 1 and vertex 2 runs essentially parallel to the upper edge of the shell (7) at a distance (d) of approximately 5 mm. The connection between vertex 2 and vertex 3 runs essentially along the φ = 48° line. The connection between vertex 3 and vertex 4 runs essentially parallel to the upper edge of the shell (7) shown in the 3D model. The connection between vertex 4 and vertex 1 runs essentially along the septal line (616). The corners of the augmentation unit A1 are rounded and describe a circular arc with a diameter of 4 mm.

[0077] In this example, the augmentation unit A2 extends from vertex 1 (φ = 116°; z = 69) via vertex 2 (φ = 182°; z = 74) and vertex 3 (φ = 212°; z = 37) to vertex 4 (φ = 116°; z = 26) and, in its implanted state, rests against the left ventricle. The connection between vertex 1 and vertex 2 runs essentially parallel to the upper edge of the shell (7) at a distance (d) of approximately 5 mm. The connection between vertex 2 and vertex 3 runs essentially along the septal line (616). The connection between vertex 3 and vertex 4 runs essentially parallel to the upper edge of the shell (7) shown in the 3D model. The connection between vertex 4 and vertex 1 runs essentially along the φ = 116° line. The corners of the augmentation unit A2 are rounded and describe a circular arc with a diameter of 4 mm.

[0078] In this example, the augmentation unit A3 extends from vertex 1 (φ = 235°; z = 92) via vertex 2 (φ = 303°; z = 108) and vertex 3 (φ = 303°; z = 64) to vertex 4 (φ = 235°; z = 48) and, in its implanted state, rests against the right ventricle. The connection between vertex 1 and vertex 2 runs essentially parallel to the upper edge of the shell (7) at a distance (d) of approximately 5 mm. The connection between vertex 2 and vertex 3 runs essentially along the φ = 303° line. The connection between vertex 3 and vertex 4 runs essentially parallel to the upper edge of the shell (7) shown in the 3D model. The connection between vertex 4 and vertex 1 runs essentially along the φ = 235° line. The corners of the augmentation unit A3 are rounded and describe a circular arc with a diameter of 4 mm.

[0079] The positioning unit P in the exemplary embodiment of the Fig. Positioning unit 17 is designed to substantially fill the spaces between the augmentation units (71) on the shell (7). The positioning unit (72) can also be described as a positioning unit (72) with extensions that substantially fill the areas on the shell (7) not filled by the augmentation units. In the exemplary embodiment, the positioning unit P has a lateral distance (d) of approximately 5 mm from the augmentation units (71) and the upper edge of the shell (7). The positioning unit (72) is also spaced from the cutting line (615), which can be advantageous during manufacturing. If the shell (7) is formed in a two-dimensional state with the at least one expandable unit, all augmentation units (71) and positioning units (72) can be attached to the shell (7) before the shell (7) is rolled into a three-dimensional shape.

[0080] The lines (41) that supply the expandable units (71, 72) are in the exemplary embodiment of Fig. 17 hydraulic or pneumatic lines (41) extend radially from the lower edge of the shell to the augmentation units. The line (41) for augmentation unit A1 runs along the line φ = 15° and terminates at a height of z = 54. The line (41) for augmentation unit A2 runs along the line φ = 165° and terminates at a height of z = 31. The line (41) for augmentation unit A3 runs along the line φ = 270° and terminates at a height of z = 65. The line (41) for positioning unit P runs along the line φ = 330° and terminates at a height of z = 25. Example 2

[0081] Fig. Figure 18 shows an embodiment of a casing (80) with at least one sensor (81) and / or an electrode (82). Shown in Fig. 18 is a like in connection with Fig. Figure 13 describes the unrolling of a 3D model. The illustrated casing (80) of this embodiment comprises eight sensors (81) or electrodes (82), four of which are pressure sensors (force sensor FS1, FS2, FS3, FS4) (81) and four of which are electrocardiogram electrodes (ECG, electrocardiogram electrode ECG1, ECG2, ECG3, ECG4) (82). The casing (80) can be made of plastic, polymer, rubber, latex, silicone, or polyurethane. The casing (80) can have a thickness of 0.1 mm to 1 mm, preferably 0.2 mm to 0.5 mm. The four pressure sensors (81) can be incorporated into the casing (80), in particular cast or welded in. The pressure sensors (81) can be provided with reinforcements that prevent buckling during compression of the device. The ECG electrodes (82) can be attached to the side of the casing (80) facing the heart. In the embodiment shown in Fig. 18 is a coordinate system as in connection with Fig.Figure 13 describes and illustrates the positions of the sensors (81) and electrodes (82) for this embodiment as follows: the pressure sensor FS1 is located at the coordinate (φ = 17°; z = 71), the pressure sensor FS2 is located at the coordinate (φ = 158°; z = 48), the pressure sensor FS3 is located at the coordinate (φ = 268°; z = 78), and the pressure sensor FS4 is located at the coordinate (φ = 67°; z = 61). ECG electrode ECG 1 is located at the coordinate (φ = 76°; z = 54), ECG electrode ECG2 is located at the coordinate (φ = 352°; z = 39), ECG electrode ECG3 is located at the coordinate (φ = 312°; z = 93), and ECG electrode ECG4 is located at the coordinate (φ = 187°; z = 18). For smaller or larger hearts, the angular coordinates for the sensors (81) and / or electrodes (82) remain essentially the same; the z-value is scaled by a factor for smaller or larger hearts, respectively.For smaller hearts, a scaling factor can range between 0.85 and 0.95, and for large hearts, a scaling factor can range between 1.05 and 1.15.

Claims

[1] Device for supporting the function of a heart, comprising: an implant, a supply unit that can be coupled to the implant, a cable that includes at least one pneumatic line and at least one electrical line, a plug system with at least one connection for a pneumatic line and at least one connection for an electrical line. [2] Device according to claim 1, wherein the plug system comprises at least one first plug part. [3] Device according to claim 2, wherein the first plug part is a male plug part. [4] Device according to one of the preceding claims, wherein the plug system comprises at least a second plug part. [5] Device according to claim 4, wherein the second plug part is a female plug part. [6] Device according to claim 5, wherein the male and female plug parts can be connected to each other. [7] Device according to claim 6, wherein the interconnected plug parts can be secured with a locking mechanism. [8] Device according to claim 7, wherein the locking mechanism is a screw lock or a snap lock. [9] Device according to claim 7, wherein the locking mechanism comprises a clamping mechanism or a bayonet lock. [10] Device according to claim 7, wherein the locking mechanism is a union nut. [11] Device according to one of the preceding claims, wherein the plug is connected to the implant and the female part of the plug is on the side facing the implant. [12] Device according to one of the preceding claims, wherein the plug comprises connections for 2, 3, 4, 5, 6, 7 or more electrical leads. [13] Device according to one of the preceding claims, wherein the plug comprises connections for 2, 3, 4, 5, 6 or more pneumatic lines. [14] Device according to one of the preceding claims, wherein the outer surfaces of the plug are rounded. [15] Device according to one of the preceding claims, wherein the plugged-in connector has no sharp edges or pointed corners. [16] Device according to one of the preceding claims, wherein the plug system comprises a seal. [17] Device according to claim 16, wherein the seal is in the connector parts, or wherein the seal is attached to the outside of the connector parts. [18] Device according to claim 16 or 17, wherein the seal is a sealing ring or a sealing strip. [19] Device according to one of the preceding claims, wherein the at least one pneumatic line comprises a seal in the plug. [20] Device according to claim 19, wherein the seal comprises a sealing ring. [21] Device according to one of the preceding claims, wherein the at least one electrical conductor comprises a seal in the plug. [22] Device according to claim 21, wherein the seal comprises a sealing ring. [23] Device according to one of the preceding claims, wherein each line comprises a separate seal. [24] Device according to claim 1, wherein the pneumatic line has an inner diameter of 1 mm to 1 cm. [25] Device according to one of claims 1 or 24, wherein the cable is between 1 cm and 50 cm long. [26] Device according to one of claims 1 or 24 to 25, wherein the cable is connected to at least one connector part. [27] Device according to any one of claims 22 to 26, wherein the cable comprises 2, 3, 4, 5 or more pneumatic lines. [28] Device according to one of claims 1 or 24 to 27, wherein the cable comprises 2, 3, 4, 5 or more electrical conductors. [29] Device according to one of claims 1 or 24 to 28, wherein the cable is provided with strain relief elements at its ends. [30] Device according to one of claims 1 or 24 to 29, wherein the cable has a sheath. [31] Device according to claim 30, wherein the sheathing is along the entire length of the cable or along areas of the cable. [32] Device according to claim 30 or 31, wherein the sheathing is different or homogeneous along the longitudinal axis of the cable. [33] Device according to claims 30 to 32, wherein the sheathing reinforces the cable. [34] Device according to one of claims 1 or 24 to 33, wherein the sheathing of the cable is formed from polyurethane, silicone, polytetrafluoroethylene (PTFE), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyamide (PA). [35] Device according to one of claims 1 or 24 to 34, wherein the cable has a cable wall, wherein the cable wall is reinforced. [36] Device according to one of claims 1 or 24 to 35, wherein the cable is flexible. [37] Device according to one of claims 1 or 24 to 36, wherein the electrical lines are electrically shielded. [38] Device according to one of claims 1 or 24 to 37, wherein the pneumatic lines and the electrical lines are fixed in the cable. [39] Device according to claim 38, wherein the conductors are cast into the cable. [40] Device according to one of claims 1 or 24 to 39, wherein the cable was extruded. [41] Device according to one of claims 1 or 24 to 34, wherein the pneumatic lines are made of polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyamide (PA), polytetrafluoroethylene (PTFE) or polyurethane or silicone. [42] Device according to one of claims 1 or 24 to 41, wherein the electrical conductors are made of copper, aluminium or silver and the conductors and / or their terminals may be gold-plated or tin-plated [43] Device according to one of claims 1 or 24 to 42, wherein the cable has an outer diameter of less than 3 cm, less than 2 cm or less than 1 cm. [44] Device according to claim 1, wherein the supply unit is located wholly or partly inside the body, or wherein the supply unit is located wholly or partly outside the body. [45] Device according to one of claims 1 or 44, wherein a plug part is attached to the supply unit. [46] Device according to claim 45, wherein the plug part is attached directly to the supply unit. [47] Device according to claim 45, wherein the plug part is attached to a cable, the cable being attached to the supply unit. [48] ​​Device according to one of the preceding claims, wherein the implant comprises a shell that can at least partially enclose a heart. [49] Device for supporting the function of a heart according to claim 48, wherein the implant comprises at least a shell that can be inserted into the shell. [50] Device for supporting the function of a heart according to claim 49, wherein the at least one shell comprises at least one expandable unit. [51] Device for supporting the function of a heart according to claim 50, wherein the at least one shell comprises at least one sensor. [52] Device for supporting the function of a heart according to claim 50 or 51, wherein the cable is designed to connect the at least one expandable unit or the at least one sensor to the supply unit. [53] Device for supporting the function of a heart according to any one of claims 48 to 52, further comprising a closure for sealing a membrane perforation. [54] Device for supporting the function of a heart according to any one of claims 48 to 53, further comprising a supply system.

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