Cardiac assist device comprising an expandable unit

Abstract

The present invention relates to a cardiac assist device (1) comprising an implant (100). The implant (100) comprises a shell (10), at least one expandable unit (20) and at least one electrode (31, 32). At least portions of the shell (10) have a two-layer structure consisting of a first layer (14) and a second layer (16).

Description

[0001] Cardiac assist device with an expandable unit

[0002] Technical area

[0003] The present invention relates to a heart assist device comprising an implant.

[0004] background

[0005] Due to illness, the pumping function of the heart can be reduced, which is also known as heart failure. Heart failure is of great and growing importance from both a medical and an economic perspective. In the second decade of this century, 23 million people worldwide will suffer from heart failure, with the annual incidence rate then reaching 2 million. In the USA alone, approximately 5 million people currently suffer from heart failure. Here, the annual incidence rate is approximately 550,000 people. In this decade alone, the number of people over 50 in the USA will double to over 10 million. The same applies to the European continent.

[0006] 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 pumping resistance, which can also negatively impact the heart's pumping function. The heart's pumping function can also be reduced by leaky valves, such as a leaky aortic or mitral valve. Impairments in the conduction of impulses in the heart can also lead to reduced pumping performance of the heart. If the heart's mobility is restricted from the outside, e.g. by a buildup of fluid in the pericardium, this can also result in reduced pumping function. Heart failure often leads to shortness of breath (particularly in left-sided heart failure) or to fluid accumulation in the lungs (particularly in left-sided heart failure) or in the legs or abdomen (particularly in right-sided heart failure).Various types of heart failure can be treated with medication or surgery. Conductive disturbances can be treated with a pacemaker under certain conditions. A defective heart valve can be surgically replaced with a prosthetic valve. Reduced pumping capacity can be treated by implanting a heart pump. One treatment approach that addresses 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.

[0007] Known mechanical heart assist devices, for example, have fluidically expandable units through which mechanical pressure can be exerted on the heart. It is also known to combine the implant of a mechanical heart assist device with ECG electrodes. The expandable units and the ECG electrodes can be supplied via a common or separate lead system. The particular challenges here are to minimize the patient's exposure to the implanted heart assist device, particularly its lead system. Furthermore, complex mechanical heart assist devices are known from the prior art that can only be implanted through a complex surgical procedure.

[0008] The object of the present invention is to provide an improved heart assist device with an implant having at least one electrode and at least one expandable unit.

[0009] Summary of the invention

[0010] The present invention relates to a heart assist device comprising an implant according to claim 1.

[0011] The heart assist device according to the invention comprises an implant. The implant comprises a shell, at least one expandable unit, and at least one electrode. The shell has, at least in sections, a two-layer structure consisting of a first layer and a second layer. In particular, the two-layer structure, at least in sections, allows for the possibility of integrating the expandable unit into the implant structure through a simple structure.

[0012] In embodiments, the shell can be designed to at least partially enclose a heart.

[0013] In embodiments that can be combined with any of the preceding embodiments, the shell can have a first recess and a second recess at its upper edge. The first recess and the second recess can be shaped such that the shell, when implanted, does not contact the coronary sinus and the vena cava. For example, the first recess 43 can prevent or at least reduce the risk of contacting the coronary sinus. The second recess 44 can prevent or at least reduce the risk of contacting the vena cava.

[0014] In embodiments that can be combined with any of the preceding embodiments, the first layer can be formed at least partially from a plastic, in particular polyurethane, silicone, polytetrafluoroethylene, polyethylene, PET, or polypropylene. Alternatively or additionally, the second layer can be formed at least partially from a plastic, in particular polyurethane, silicone, polytetrafluoroethylene, polyethylene, PET, or polypropylene. In particular, the first layer and / or the second layer can comprise a thermoplastic polyurethane (TPU).

[0015] In embodiments that can be combined with any of the preceding embodiments, the shell can be manufactured by thermoforming. In alternative embodiments, the shell can also be manufactured by injection molding, casting, spraying, additive manufacturing, or other suitable processes. A shell manufactured by thermoforming can be considered particularly advantageous because the various elements and / or layers of the implant can be shaped using a single basic mold.

[0016] In embodiments that can be combined with any of the preceding embodiments, the first layer can be a film. Alternatively or additionally, the second layer can be a film. In particular, when both layers are formed by films, the two-layer structure can also be referred to as a film structure. In embodiments that can be combined with any of the preceding embodiments, the shell can have an opening at its lower tip. This can result in various advantageous effects, such as simplified manufacturing, for example when removing the implantation aid (e.g. film bag). In addition, defibrillation functionality can be increased. Furthermore, the fit of the implant can be improved by preventing the apex of the heart from striking the implant.In particular, the opening may be free of leads or other parts of the implant to achieve such advantages.

[0017] In embodiments that can be combined with any of the preceding embodiments, the implant can further comprise a ring arranged on an upper edge of the shell. The ring can achieve a type of shape memory effect or spring effect, and the shell can be easily returned to the desired shape at the implantation site during implantation. In particular, the ring can be harder than the shell. This can achieve a type of "spring effect" of the ring. The layered structure, in particular the film structure, in combination with the ring makes it possible to dispense with an otherwise frequently necessary stiffening structure, such as a lattice structure. In some embodiments, the ring does not necessarily have to have a closed structure, but can also have two ends that are spaced apart from one another. In other words, the ring can be closed or interrupted.The ring can also be referred to as an annular element. In particular, the ring can also be formed from two or more subsections that are joined to one another or arranged at a distance from one another at the upper edge of the shell. In particular, the ring can extend at least 60%, preferably at least 75%, and particularly preferably at least 90% along a circumference of the upper edge. An extension of 100% along the circumference of the upper edge is achieved when the ring has a closed structure.

[0018] In embodiments that can be combined with any of the preceding embodiments, the ring can be molded onto the upper edge of the shell. In embodiments, the shape of the ring can be shaped such that the ring does not touch the vena cava and / or coronary sinus in the implanted state. In embodiments, the ring can, for example, be shaped separately (e.g., contoured). The ring can then be attached to the shell. For example, the ring can be thermally bonded to the shell, in particular its upper edge. Molded can be understood to mean that the ring is brought into a shape that the ring has without external force application or to which the ring returns or strives to return after deformation without external force application. Alternatively, the ring can be designed to return to its previous state after mechanical deformation.In other words, the ring may comprise a spring effect that allows reversible deformations and / or a targeted return to the state before the deformation.

[0019] In embodiments that can be combined with any of the preceding embodiments, the ring can extend along the upper edge of the shell. In particular, the ring can form and / or shape the upper edge of the shell. In embodiments, the ring can be attached to the outer side of the first layer in such a way that, in the implanted state, no components of the ring protrude toward the heart muscle. Alternatively, the ring can be designed and attached to the shell in such a way that components of the ring only protrude outward.

[0020] In embodiments that can be combined with any of the preceding embodiments, the ring can be arranged between the first layer and the second layer. Alternatively or additionally, the ring can be attached to at least one of the first and the second layer. Alternatively or additionally, the ring can be enclosed, in particular at least partially enclosed, by a third layer. The third layer can be connected to the first layer and / or the second layer, in particular connected in an overlapping manner. For example, the third layer can be designed as a U-shaped overlap layer. The two side legs of the U-shape can, for example, be arranged in an overlapping manner, in particular connected, to the first layer or the second layer, respectively.

[0021] In embodiments that can be combined with any of the preceding embodiments, the ring can be attached to the shell. In particular, the ring can be welded to the shell. In embodiments that can be combined with any of the preceding embodiments, the ring can have a round cross-section. In particular, the ring can have a circular cross-section. In embodiments, the ring can also have other cross-sectional shapes, such as an oval, polygonal, trapezoidal, or teardrop-shaped cross-sectional shape. A reduced risk of injury can be achieved, in particular, if a rounded upper edge is provided. A round, in particular circular, cross-sectional shape can simplify manufacturing.

[0022] In embodiments that can be combined with any of the preceding embodiments, the ring can be made at least partially of a plastic. In particular, the ring can comprise polyurethane and / or polyamide. In alternative embodiments, the ring can comprise silicone, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, and / or polypropylene.

[0023] In embodiments that can be combined with any of the preceding embodiments, the ring can have a greater hardness than the shell. Alternatively or additionally, the ring can comprise a material with a Shore hardness D of at least 50. Preferably, the ring can comprise a material with a Shore hardness D of at least 60. Particularly preferably, the ring can comprise a material with a Shore hardness D of at least 65. In particular, the ring can be made from a material with a corresponding Shore hardness D of at least 50, preferably at least 60, particularly preferably at least 65. In embodiments, the material of the ring can have a Shore hardness D between 50 and 85, preferably between 55 and 80, and particularly preferably between 60 and 75, such as 65. Such hardness values ​​can achieve a good ratio between hardness or dimensional stability and deformability.

[0024] In embodiments that can be combined with any of the preceding embodiments, the shell can comprise a material with a Shore hardness D of maximum 45. Preferably, the shell can comprise a material with a Shore hardness D of maximum 40. Particularly preferably, the shell can comprise a material with a Shore hardness D of maximum 35. In particular, the shell can be made from a material with a corresponding Shore hardness D of maximum 45, preferably maximum 40, particularly preferably maximum 35. In embodiments, the material of the shell can comprise a Shore hardness D between 15 and 50, preferably between 20 and 45, and particularly preferably between 25 and 40, for example 30 or 35. In particular, the material of the shell can comprise a Shore hardness A between 75 and 95. This can provide good compressibility during implantation and good functionality during operation after implantation.

[0025] In embodiments that can be combined with any of the preceding embodiments, the at least one expandable unit can comprise a chamber. The at least one chamber can be formed between the first layer and the second layer. In particular, the first layer and the second layer can be sealingly connected to one another along a closed line to form the chamber. For example, the chamber can be formed by welding or gluing the first layer and the second layer along the closed line.

[0026] In embodiments that can be combined with any of the preceding embodiments, the at least one expandable unit can comprise a connecting piece arranged on the shell for connection to a fluidic supply line of a supply system of the heart assist device. In particular, the connecting piece can comprise an outlet that is inclined relative to an outer surface of the shell in order to guide the fluidic supply line laterally along the shell. In embodiments, the connecting piece can comprise a bend or a channel that is inclined relative to the outer surface. In other words, the connecting piece can define a channel that extends from an inlet into the chamber to an outlet into the fluidic supply line. The channel can be straight or curved. In embodiments, an angle between the inlet into the chamber and the outlet towards the supply line can, for example, comprise a value between 0° and 90°.The inlet into the chamber, in particular a cross-sectional area of ​​the inlet, can be formed parallel to a chamber surface, for example on the outer surface of the shell. In particular, in such an embodiment, the angle can be greater than 0°. Preferably, in such embodiments, the angle can comprise a value between 60° and 90°. This allows the supply line to be guided laterally away from the chamber or from the outlet towards the supply line. In embodiments, the inlet can be inclined relative to the chamber (e.g., a tubular section penetrating diagonally into the chamber); in particular, the angle between inlet and outlet can then also have a value of 0°. In embodiments that can be combined with any of the preceding embodiments, the connecting piece can be designed to receive the fluidic supply line parallel to an outer surface of the shell or inclined away from the outer surface.In particular, the connecting piece can be designed to receive the fluidic supply line at an angle between 0° and 30°, preferably between 0° and 15°, relative to an outer surface of the shell.

[0027] In embodiments that can be combined with any of the preceding embodiments, the connecting piece can be designed to receive the fluidic supply line via a spacing spaced from an outer surface of the expandable unit. By spacing the supply line connection in the connecting piece from the chamber surface, contact between the supply line and the chamber can be prevented or at least reduced during movement of the chamber. This can reduce the risk of damage to the chamber. In embodiments, the spacing in the normal direction to the outer surface of the shell can be 0.5 mm to 2.5 mm. In particular, the spacing in the normal direction to the outer surface of the shell can be 1 mm to 2 mm. Preferably, the spacing in the normal direction to the outer surface of the shell can be at least 1.5 mm.Particularly preferably, the spacing in the normal direction to the outer surface of the shell can be 1.5 mm or 1.5 mm + / - 0.25 mm. The spacing can be understood as the distance between the outer surface and the fluid supply line in the area of ​​the outlet of the connecting piece.

[0028] In embodiments that can be combined with any of the preceding embodiments, the connecting piece can be fluidically connected to the chamber at a distance from the closed line. In particular, the connecting piece can be arranged at a distance from the closed line toward the chamber interior.

[0029] In embodiments that can be combined with any of the preceding embodiments, the at least one expandable unit can be expanded by filling it with a fluid. In embodiments, liquids, gases, or solids (such as nanoparticle mixtures), or mixtures of liquids and / or gases and / or solids, can be used as the fluid for filling the expandable unit or its chamber. In embodiments that can be combined with any of the preceding embodiments, the at least one expandable unit can be adjustable between a non-expanded configuration and an expanded configuration. In particular, the at least one expandable unit can be expanded to an inside of the shell and to an outside of the shell during the adjustment from the non-expanded configuration to the expanded configuration.This can be achieved, for example, by forming the chamber of the expandable unit from the two layers. This not only advantageously affects the ventricle, but also provides simple support to the pericardium.

[0030] In embodiments that can be combined with any of the preceding embodiments, the implant can comprise a plurality of expandable units spaced apart from one another. In particular, the implant can comprise three expandable units spaced apart from one another. In particular, each of the expandable units can be connectable or connected to a fluidic supply line via a connecting piece. In embodiments, at least one electrode can be arranged between two adjacent expandable units. In particular, two electrodes can be arranged between two adjacent expandable units.

[0031] In embodiments that can be combined with any of the preceding embodiments, the implant can further comprise at least one electrode bar to which at least one of the at least one electrode is attached. In particular, the at least one electrode can be arranged with its active side facing the inside of the shell. An opposite region of the electrode (toward the outside of the shell; the side of the shell facing away from the heart) can be insulated, in particular electrically insulated. This can improve the quality of the desired ECG signals.

[0032] In embodiments that can be combined with any of the preceding embodiments, the electrode bridge can be arranged on an outer side of the shell. In particular, the electrode bridge can be attached to the outer side of the shell. In embodiments, the electrode bridge can be arranged in a correspondingly formed recess on the outer side of the shell. In particular, the recess can be arranged at a predefined position of the implant. This can ensure or simplify the intended placement of the electrode bridge or the electrodes attached thereto. The recess can be formed, for example, by omitting a structuring in an area on the outer side of the shell.

[0033] In embodiments that can be combined with any of the preceding embodiments, the shell can have a passage to an inner side of the implant. The passage can be arranged and configured such that the at least one electrode protrudes with its active side through the passage to the inner side. In embodiments, the active sides can be arranged flush with the inner side of the implant. This can minimize or at least reduce the risk of injury.

[0034] In embodiments that can be combined with any of the preceding embodiments, the at least one electrode can be embedded in the electrode web such that the active side of the electrode protrudes from the electrode web.

[0035] In embodiments that can be combined with any of the preceding embodiments, the at least one electrode can be surrounded by a material to form the electrode web. In particular, the at least one electrode can be overmolded with a material to form the electrode web. An electrical supply line of the supply line system that leads to the at least one electrode can also be at least partially overmolded and / or embedded in the electrode web. Alternatively or additionally, the electrode web can be provided as a prefabricated element, and the at least one electrode and / or the electrical supply line can be at least partially inserted, optionally clamped or glued, into the electrode web.

[0036] In embodiments that can be combined with any of the preceding embodiments, the electrode web may comprise a plastic material. In particular, the electrode web may comprise polyurethane, epoxy, silicone, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polyamide, and / or polypropylene.

[0037] In embodiments that can be combined with any of the preceding embodiments, two electrodes can be attached to the electrode bridge. In particular, the two electrodes can be arranged in opposite end regions of the electrode bridge. This can improve the quality of the ECG signals. In addition, a greater distance between the electrodes allows a type of 3D vector of the electrical excitation to be calculated. The greater the distance between the electrodes, the greater the potential differences and the larger this vector becomes. Depending on the arrangement of the two electrodes in the electrode bridge, two passages, one each for an electrode, can be provided in the implant or shell. In embodiments, the two end regions can be connected to one another via a waist. The waist can improve the flexibility and adaptability of the electrode bridge.In addition, the bridge can protect electrical leads from intracorporeal damage. By tapering the electrode bridge, the area of ​​the adjacent expandable units is not restricted, or at least less restricted.

[0038] In embodiments that can be combined with any of the preceding embodiments, electrical leads to the two electrodes can have a common lead section. The common lead section can be separated in the region of the electrode web, in particular within the electrode web.

[0039] In embodiments that can be combined with any of the preceding embodiments, the electrode web can comprise a strain relief for an electrical supply line to the at least one electrode. In embodiments, the strain relief can be formed by a curved course of the electrical supply line within the electrode web. Alternatively or in addition to the curved course, mechanical strain relief can be provided by a separate mechanical pull cable. The mechanical pull cable can, for example, be shorter than the electrical supply line, so that a tensile force is absorbed first by the mechanical pull cable.

[0040] In embodiments that can be combined with any of the preceding embodiments, the electrode bridge can be arranged on the shell such that a longitudinal extension of the electrode bridge is arranged substantially orthogonally to the upper edge of the shell. In embodiments that can be combined with any of the preceding embodiments, the implant can comprise three electrode bridges. The electrode bridges can be arranged at a distance, in particular circumferentially, on the outer side of the shell. In embodiments, the electrode bridges can each be arranged between two adjacent expandable units.

[0041] In embodiments that can be combined with any of the preceding embodiments, the shell can comprise a conductive region, at least in sections. The conductive region can have a perforation and / or multiple conductive elements to establish a fluidic and / or conductive connection between the inside of the shell and the outside of the shell. In particular, this can improve electrical conductivity through the shell, which in turn can improve defibrillability and surface ECG signal quality.

[0042] In embodiments that can be combined with any of the preceding embodiments, the conductive region can comprise a perforation. The perforation can comprise a plurality of passages between the inside and the outside of the shell. For example, the perforation can comprise at least 5, at least 10, at least 15, or at least 30 perforation passages. In embodiments, the perforation can comprise a maximum of 150, a maximum of 120, a maximum of 100, or a maximum of 80 perforation passages. In particular, the perforation can comprise a number of perforation passages between each of the aforementioned minimum numbers and each of the aforementioned maximum numbers. For example, the perforation can comprise between 5 and 150 perforation passages. In embodiments, the passages of the perforation can be circular. In alternative embodiments, the passages can be oval, elongated, and / or polygonal.In particular, the passages can be designed differently or identically, for example with regard to shape and / or size. In advantageous embodiments, the passages can be designed identically and circularly. This allows the passages to be easily manufactured and simultaneously offer a good yield in terms of their conductivity potential (e.g., compared to linear, elongated shapes). In embodiments, the perforation passages can have a diameter between 0.1 mm and 5 mm. Preferably, the perforation passages can have a diameter between 0.5 mm and 2.5 mm. Particularly preferably, the perforation passages can have a diameter between 0.75 and 1.5 mm. For example, the perforation passages can have a diameter of 1 mm + / - 0.25 mm. In embodiments, the perforation passages can have different or identical dimensions, in particular diameters, and / or geometries.In embodiments, the perforation can be arranged in regions of the shell adjacent to the at least one electrode web and / or to the at least one expandable unit. Alternatively, the perforation can be arranged outside the region of the electrode webs and the expandable units. In particular, the perforation can be arranged in regions of the shell with only one layer.

[0043] In embodiments, the perforation can, for example, have a surface area of ​​0.1% to 20%, in particular 0.5% to 10%, and preferably 1% to 5%, relative to a non-perforated implant, relative to the total surface area on the outer side between the upper edge and the lower opening. This ensures that the perforation only covers a specific portion of the shell, thus not compromising the stability or structure-providing function of the shell.

[0044] In embodiments, the perforation can be provided in the shell independently of or dependent on the production of the shell. For example, the perforation can be introduced into the shell by punching out the passages. If the shell is produced by thermoforming, for example, the perforation can be introduced into the shell before and / or after thermoforming. Introducing the perforation before thermoforming has the advantage of easier production, since only the layered or flat base material of the shell needs to be perforated. Introducing the perforation after thermoforming has the advantage that the perforation passages can be introduced with greater positional and shape precision with regard to the thermoformed shell geometry. The perforation can also be partially formed during thermoforming or its passages can be enlarged.For example, the base material of the shell can be perforated or pierced with small holes before thermoforming (e.g., with a needle-like perforating device), whereby these small holes are at least expanded by stretching during thermoforming to form the holes. Even when using other shell manufacturing processes, the perforation can be introduced into the shell before (or during) or after the shell's production / shaping. For example, (injection) molds used in casting or injection molding can have geometries corresponding to the holes or perforations.

[0045] In some embodiments, the perforations may not be evenly distributed across the entire shell, but rather provided only in locations that allow this. This results in an irregular distribution of the perforations. This distinguishes the perforations from fabric- and mesh-like constructs, in which the fabric and mesh openings are generally evenly distributed. In contrast to mesh- and fabric-like constructs, the described perforations or their passages are preferably dimensionally stable. In other words, this means that the perforations or their passages do not change their shape. Mesh and fabric structures, on the other hand, have variable openings.

[0046] In embodiments that can be combined with any of the preceding embodiments, the implant can have a structured surface that promotes the ingrowth of cells, in particular macrophages and / or fibroblasts. In embodiments, the structured surface can comprise a foamed layer. In particular, the structured surface can comprise a film made of a foam material. In embodiments, the film made of foam material can be connected to the first layer and / or the second layer of the shell by a thermal process. The structured surface can be positively and / or materially connected to the first layer and / or the second layer of the shell. In embodiments, the film made of foam material can be applied to the first and / or the second layer of the shell, in particular thermoformed.

[0047] In embodiments that can be combined with any of the preceding embodiments, the structured surface can be arranged on an inner side and / or an outer side of the shell.

[0048] In embodiments that can be combined with any of the preceding embodiments, the structured surface can be arranged at least partially on the at least one expandable unit. In embodiments that can be combined with any of the preceding embodiments, the structured surface can be arranged at least partially on the connecting piece.

[0049] In embodiments that can be combined with any of the preceding embodiments, the structured surface can be arranged at least partially on the electrode web.

[0050] In embodiments that can be combined with any of the preceding embodiments, the structured surface can at least partially enclose the ring. In particular, a separate film made of a foam material can be molded around the upper edge of the ring. Optionally, the separate film can overlap the structured surface on the inside and / or outside of the shell.

[0051] In embodiments that can be combined with any of the preceding embodiments, the heart assist device may further comprise a lead system connected to the implant. The lead system may be routed laterally away from the implant in a proximal direction.

[0052] The term proximal or proximal direction refers to areas or directions along the lead that are closer to or lead to the care device or a third operator, e.g., a physician. Distal areas or directions refer to areas and directions along the lead that are closer to or lead to the medical implant. In particular, distal areas and directions can refer to a course of the lead system between the care unit and the implant. For example, the lead system can be connected to the implant at a distal end. At a proximal end, the lead system is connected to the care unit.

[0053] In embodiments that can be combined with any of the preceding embodiments, the supply system, particularly in the implanted state, can be guided anteriorly and / or to the right in the proximal direction along the shell and then away from the implant. In particular, the supply system can be guided anteriorly and further to the right along the shell in the implanted state via the left ventricle.

[0054] In embodiments that can be combined with any of the preceding embodiments, the supply system can be routed beyond the upper edge of the implant, particularly in the implanted state. This allows the supply system to be routed to the right within the body, above the diaphragm, from the patient's perspective. The diaphragm is only penetrated on the right side. This can prevent or at least reduce damage to the diaphragm and any impairment of its freedom of movement. Furthermore, the transmission of diaphragmatic movement via the supply line to the implant can be reduced.

[0055] In embodiments that can be combined with any of the preceding embodiments, the supply line system can comprise at least one fluidic supply line and at least one electrical supply line for supplying the implant from a supply unit. In embodiments, the supply line system can comprise three fluidic supply lines.

[0056] In embodiments that can be combined with any of the preceding embodiments, the lead system can comprise a plurality of, in particular at least six, preferably nine, electrical leads. In embodiments, each of the plurality of electrical leads can be connected to an electrode of the at least one electrode. In particular, the heart assist device can comprise six electrodes and three electrode webs. In embodiments, two electrodes can be placed in each of the three electrode webs. In embodiments, at least two electrical leads can be guided in a common lead section in the distal direction to the implant. In particular, the at least two electrical leads can be guided in the common lead section up to the electrode web in the distal direction. In the region of the electrode web, in particular within the electrode web, the common lead section can be separated.This means that the two electrical leads are spatially separated from each other and led to the respective electrode.

[0057] In embodiments that can be combined with any of the preceding embodiments, the at least one fluidic supply line can be connected to the at least one expandable unit. In particular, a first fluidic supply line can be connected to a first expandable unit. A second fluidic supply line can be connected to a second expandable unit. A third fluidic supply line can be connected to a third expandable unit.

[0058] In embodiments that can be combined with any of the preceding embodiments, the at least one fluidic supply line can be routed anteriorly and / or to the right in the proximal direction along the shell, particularly in the implanted state. In particular, the fluidic supply line can be routed anteriorly and further to the right along the shell in the implanted state via the left ventricle.

[0059] In embodiments that can be combined with any of the preceding embodiments, at least one of the three fluidic supply lines can be attached to the implant via a first fixation point in order to guide the at least one fluidic supply line along the shell via the first fixation point. The first fixation point can be used to specifically guide the at least one fluidic supply line along the shell, in particular past or around the expandable units. In embodiments, the first fixation point can be arranged at a distance from the at least one expandable unit. In embodiments, the first fixation point can be arranged on or adjacent to an electrode web. In embodiments, the first fixation point can be arranged on or adjacent to an end region of the electrode web.In particular, the first fixation point can be arranged on or adjacent to the electrode bridge, which is located closer to the lower opening of the shell. This results in the advantage that the at least one fluidic supply line is routed in a lower region of the implant. Compared to a fluidic supply line that runs along or over the expandable unit, the fluidic supply line can have less influence on the expandable unit.

[0060] In embodiments that can be combined with any of the preceding embodiments, at least two of the three fluidic supply lines can be attached to the implant via a second fixation point in order to guide the at least two fluidic supply lines along the shell via the second fixation point. In embodiments, the second fixation point can be arranged at a distance from the at least one expandable unit. In embodiments, the second fixation point can be arranged on or adjacent to an electrode web. In embodiments, the second fixation point can be arranged on or adjacent to an end region of the electrode web. In particular, the second fixation point can be arranged on or adjacent to the electrode web that is arranged closer to the lower opening of the shell. This results in the advantage that the at least two fluidic supply lines are guided in a lower region of the implant.Compared to a fluidic supply line that runs along or over the expandable unit, the fluidic supply line can have less influence on the expandable unit.

[0061] In embodiments that can be combined with any of the preceding embodiments, the second fixation point can be arranged proximal to the first fixation point.

[0062] In embodiments that can be combined with any of the preceding embodiments, the fixing point can be designed to fix the fluidic supply line at a distance from an outer surface of the shell. By spacing the fluidic supply line from the outer surface of the shell, contact between the fluidic supply line and the outer surface of the shell can be reduced during movement of the shell or its parts. In particular, contact or chafing can be avoided or at least reduced. This can reduce the risk of damage to the shell and / or the expandable units. In embodiments, the spacing in the normal direction to the outer surface of the shell can be 0.5 mm to 2.5 mm. In particular, the spacing in the normal direction to the outer surface of the shell can be 1 mm to 2 mm. Preferably, the spacing in the normal direction to the outer surface of the shell can be at least 1.5 mm.Particularly preferably, the spacing in the normal direction to the outer surface of the shell can be 1.5 mm or 1.5 mm + / - 0.25 mm. The spacing can be understood as the distance between the outer surface and the fluid supply line in the region of the fixation point.

[0063] In embodiments that can be combined with any of the preceding embodiments, the supply line system can comprise a first splitting section. At the first splitting section, at least one fluidic supply line can be branched off in the distal direction from the other supply lines of the supply line system. In embodiments that can be combined with any of the preceding embodiments, the supply line system can comprise a second splitting section. At the second splitting section, at least one fluidic supply line can be branched off in the distal direction from the other supply lines of the supply line system. In embodiments, the second splitting section can be arranged distally of the first splitting section.

[0064] In embodiments that can be combined with any of the preceding embodiments, at least one of the first or the splitting section can be arranged at one of the first or the second fixing point.

[0065] In embodiments that can be combined with any of the preceding embodiments, the first splitting section can be arranged proximally in front of the implant.

[0066] In embodiments that can be combined with any of the preceding embodiments, the second splitting section can be arranged on the implant.

[0067] In embodiments that can be combined with any of the preceding embodiments, the lead system can comprise at least one anchoring sheath. The anchoring sheath can be designed to promote cell ingrowth. In embodiments, the lead system can comprise at least one cardiac anchoring sheath and a proximal anchoring sheath. In embodiments, the cardiac anchoring sheath can be designed to promote migration of macrophages and / or fibroblasts. In embodiments, the proximal anchoring sheath can be designed to promote ingrowth of fibroblasts. In embodiments, an anchoring sheath can be arranged in the proximal direction directly behind and / or on the first splitting section. In embodiments, an anchoring sheath can be arranged in the proximal direction directly behind and / or on the second splitting section.This ensures that the individual supply lines are separated only shortly before reaching their destination. This ensures that the supply lines are routed together over a large portion of the supply line route, which can result in less stress for the patient. In some embodiments, the electrical supply lines can be arranged, in particular attached, to the fluidic supply lines. For example, the electrical supply lines can be arranged between the fluidic supply lines. This provides additional protection for the electrical supply lines. In some embodiments, the anchoring sheath can be a cardiac anchoring sheath.

[0068] In embodiments that can be combined with any of the preceding embodiments, excess cable length of the at least one electrical supply line can be stowed in the anchoring sheath. In particular, excess cable length of the at least one electrical supply line can be stowed in the anchoring sheath, which is arranged in the proximal direction directly behind the first splitting section.

[0069] In embodiments that can be combined with any of the preceding embodiments, the supply system may comprise an intracorporeal supply section. The intracorporeal supply section may be designed for connection to the implant. In embodiments, the supply system may have an extracorporeal supply section for connection to a supply unit.

[0070] In embodiments that can be combined with any of the preceding embodiments, the cardiac assist device can further comprise a supply unit. In embodiments, the supply unit can be connected to the implant via the supply system. In embodiments, the supply unit can be designed to control a function of the implant. In particular, the supply unit can be designed to supply, in particular control, the implant fluidically and / or electrically.

[0071] Short description of the characters

[0072] Further features are apparent from the accompanying drawings, which form a part of this disclosure. The drawings are intended to further explain the present disclosure and to enable those skilled in the art to put the present disclosure into practice. However, the drawings are to be understood as non-limiting examples. Common reference numerals in different figures indicate the same or similar features. FIG. 1 shows a perspective view of the heart assist device according to the invention with an implant, a lead system, and a supply unit;

[0073] FIG. 2 shows a detailed section of the heart assist device from FIG. 1;

[0074] FIG. 3a shows a perspective view of the implant;

[0075] FIG. 3b shows a view of the implant from below;

[0076] FIG. 4a shows a posterior side view of the implant;

[0077] FIG. 4b shows the implant from FIG. 4a with a structured surface and perforation;

[0078] FIG. 5a shows a view of the implant from below;

[0079] FIG. 5b shows the implant from FIG. 5a with a structured surface and perforation;

[0080] FIG. 6a shows the implant in a sectional view along section AA of FIG. 5b in a non-expanded state;

[0081] FIG. 6b shows the implant of FIG. 6a in an expanded state;

[0082] FIG. 7 shows a perspective view of the implant;

[0083] FIG. 8a shows an exemplary electrode bridge of the implant from an active side of the electrodes;

[0084] FIG. 8b shows the electrode bridge of FIG. 8a from a non-active side of the electrodes;

[0085] FIG. 9a shows a schematic representation of a human torso with an implanted implant;

[0086] FIG. 9b shows the torso with implant in a sectional view along section BB of Fig. 9a;

[0087] FIG. 10 shows an exemplary ECG diagram in which an optimized ECG is plotted against a damped ECG;

[0088] FIGS. 11-19 show selected steps of an implantation method of the implant; FIG. 20a shows a simplified representation of the implant with circular corrugations in a sectional view corresponding to section AA of FIG. 5b in a non-expanded state;

[0089] FIG. 20b shows the implant of FIG. 20a in an expanded state;

[0090] FIG. 20c shows a comparison of the expandable units of the implants of Figs. 6a and 20a in a highly simplified representation;

[0091] FIGS. 21-30 show exemplary embodiments of the implant with an expansion arrangement.

[0092] Detailed description

[0093] Embodiments of the heart assist device 1 according to the present disclosure are explained below with reference to the drawings.

[0094] Fig. 1 shows an exemplary heart assist device 1. The exemplary heart assist device 1 comprises an implant 100, a lead system 200 and a supply unit 300. In the implanted state, the implant 100 can partially enclose a patient's heart. The implant 100 can support a patient's cardiac function. In this regard, Fig. 9a shows a schematic, highly simplified representation of an exemplary, implanted heart assist device 1 with the implant 100 and a section of the lead system 200. The implant 100 can thus also be referred to as a medical implant 100 or cardiac implant 100. For this purpose, the implant 100 comprises a shell 10 and at least one expandable unit 20. Furthermore, the implant can comprise at least one electrode 31, 32. The implant 100 can be supplied with energy via the lead system 200.For this purpose, the supply line system 200 is connected to the implant 100 and the supply unit 300 and comprises at least one fluidic supply line 220. In other words, the supply unit 300 can be connected to the implant 100 via the supply line system 200. The supply unit 300 can be designed to control a function of the implant 100. In particular, the supply unit 300 can be designed to supply the implant 100 with fluid and / or electricity, in particular to control it. The supply unit 300 can in particular remain outside the patient's body. A section of the supply line system 200 thus remains outside the patient's body. This section can also be referred to as an extracorporeal supply line section 200b. A section of the supply line system 200 that leads to the implant 100 orconnected thereto, can remain within the patient's body and is also referred to as an intracorporeal supply line section 200a. Schematically, a skin exit region is represented by the vertical line in Fig. 1, from which the extracorporeal supply line section 200b runs in the proximal direction 2b. The intracorporeal supply line section 200a runs in the distal direction 2a from the skin exit region. In other words, the supply line system 200 can comprise an intracorporeal supply line section 200a and an extracorporeal supply line section 200b. The intracorporeal supply line section 200a can be designed for connection to the implant 100. The extracorporeal supply line section 200b can be designed for connection to a supply unit 300. The term proximal or proximal direction refers to areas or directions along the supply line that are available to the supply device 300 or a third operator, e.g.a physician, are closer to or lead to the latter. Distal regions or directions refer to regions and directions along the supply line that are closer to or lead to the medical implant 100. In particular, distal regions and directions can refer to a course of the supply line system 200 between the supply unit 300 and the implant 100. Thus, the supply line system 200 can be connected to the implant 100 at a distal end. At a proximal end, the supply line system 200 is connected to the supply unit 300.

[0095] The following discusses the individual aspects of the cardiac assist device 1 in more detail, particularly individual aspects of the implant 100 and the lead system 200. Although some features are explained using only one exemplary element, e.g., an expandable unit 20, it should be understood that other elements may be configured in the same or different ways.

[0096] As can best be seen in Figs. 6a and 6b, the shell 10 has, at least in sections, a two-layer structure consisting of a first layer 14 and a second layer 16. In particular, the at least partially two-layer structure makes it possible to integrate the expandable unit 20 into the implant structure using a simple structure. For example, the expandable unit 20 can be formed by the first layer 14 and the second layer 16. In particular, the first layer 14 and the second layer 16 can be sealingly connected to one another along a closed line 15 to form the expandable unit 20 (see also Fig. 4a). More specifically, the at least one expandable unit 20 can comprise a chamber 22. The chamber 22 can be formed between the first layer 14 and the second layer 16.In particular, the first layer 14 and the second layer 16 can be sealingly connected to one another along the closed line 15 to form the chamber 22. For example, the chamber 22 can be formed by welding or gluing the first layer 14 and the second layer 16 along the closed line 15. In preferred embodiments, the first layer 14 and the second layer 16 can be made from a film made of a plastic material, in particular from a thermoplastic polyurethane (TPU). In particular, if both layers 14, 16 are formed from films, the two-layer structure can also be referred to as a two-layer film structure. In particular, the shell 10 can be produced by thermoforming.A shell 10 produced by thermoforming can be considered particularly advantageous because the various elements and / or layers of the implant 100 can be shaped using a single basic mold. In embodiments, the shell 10 can also be produced by injection molding, casting, spraying, additive manufacturing, or other suitable processes.

[0097] In alternative embodiments, the first layer 14 and / or the second layer 16 may not comprise a film and / or may be made of a material other than thermoplastic polyurethane. For example, the first layer 14 and / or the second layer 16 may be formed at least partially from a plastic, in particular silicone, polytetrafluoroethylene, polyethylene, PET, or polypropylene.

[0098] In the embodiments of Figs. 3a, 3b, 4a and 6a, 6b, the shell 10 has a two-layer structure in the region of the expandable units 20. In regions of the shell 10 between the expandable units 20, the shell 10 has only the first layer 14. Alternatively, the second layer 16 is arranged only in the region of the expandable units 20. In particular, the second layer 16 can be arranged on an inner side 11 of the shell 10. Further alternatively, the shell 10 can have a two-layer structure only in the region of the expandable units 20. In other words, the shell 10 has at least partially a single-layer structure. In alternative embodiments, the shell 10 could also have a two-layer structure in other regions or entirely.A single-layer structure without the second layer 16 in at least some areas of the shell 10 has the advantage of material savings, less discomfort for the patient and, particularly in combination with the perforation 50 explained below, can lead to advantages such as improved conductivity and simplified production of the perforation 50.

[0099] The shell shape of the implant 100 can be clearly seen, particularly with reference to Figs. 3a, 3b and 4a. Corresponding to the shape of a shell, the shell 10 of the implant 100 has an upper edge 40. The implant 100 or the shell 10 further has an inner side 11 (can also be referred to as inner surface 11) and an outer side 12 (can also be referred to as outer surface 12). The inner side 11 of the implant can be understood as a surface or side oriented towards the heart muscle in the implanted state. In particular, the inner side 11 can be at least partially in contact with the patient's heart, more precisely with the patient's heart muscle, in the implanted state of the implant 100 (see also Fig. 9a). Alternatively, the shell 10 is designed to at least partially enclose the heart. More precisely, the implant 100 orThe shell 10 defines a lower region of the heart, in particular the heart chambers, also referred to as ventricles. This means that even in the implanted state, the upper edge 40 of the shell 10 defines an upper side of the implant 100 or of the shell 10 relative to the anatomy of the heart. Top can be understood as closer to the atria or, with respect to the patient, as the head side. Bottom can be understood as closer to the tip of the heart (also referred to as the apex) or, with respect to the patient, as the foot side. The outer side 12 can be understood as a surface or side oriented away from the heart muscle or toward the pericardium in the implanted state. In particular, the outer side 12 can be at least partially in contact with the pericardium of the patient's heart or be surrounded by the pericardium in the implanted state of the implant 100. On its lower side, the shell 10 can have an opening 48 (can also be referred to as the "lower opening 48").This can result in various advantageous effects, such as simplified manufacturing, for example, when removing the implantation aid (e.g., foil pouch). Furthermore, defibrillation functionality can be increased. Furthermore, the fit of the implant 100 can be improved by preventing the apex of the heart from striking the implant 100. For this reason, the opening 48 can also be referred to as an "apex opening 48." In particular, the opening 48 can be free of leads or other parts of the implant 100 to achieve such advantages. In other words, the opening 48 can provide a free passage.

[0100] As can be clearly seen in Fig. 4a, the shell 10 can have a first recess 43 and a second recess 44 at its upper edge 40. Alternatively, the upper edge 40 can define the first recess 43 and the second recess 44. The first recess 43 and the second recess 44 can be shaped such that the shell 10, in the implanted state, does not touch the coronary sinus and the vena cava. The recesses 43, 44 can therefore extend towards the underside of the shell 10, more precisely towards the lower opening 48. For example, the first recess 43 can prevent or at least reduce the risk of touching the coronary sinus. The second recess 44 can prevent or at least reduce the risk of touching the vena cava.

[0101] As can be seen from Figs. 3a, 3b, 4a, 5a and 7, the implant 100 can further comprise a ring 46. The ring 46 is arranged on the upper edge 40 of the shell 10. The ring 46 can achieve a type of shape memory effect or spring effect, and the shell 10 can be easily brought back into the desired shape at the implantation site during implantation. In particular, the ring 46 can have a greater hardness than the shell 10. This can achieve a type of "spring effect" of the ring 46. The layered structure, in particular the film structure, in combination with the ring 46 makes it possible to dispense with an otherwise often necessary and complex stiffening structure, such as a lattice structure. In addition, the film structure can provide a certain elasticity orDeformability can be provided, whereby adaptability of the shell 10 to changes in size (reduction or enlargement) of the heart during operation can be achieved. In embodiments, the ring 46 does not necessarily have to have a closed structure, but can also have two or more ends that are spaced apart from one another. In other words, the ring 46 can be closed or interrupted. The ring 46 can also be referred to as an annular element. In particular, the ring can also be formed from two or more subsections that are joined to one another or spaced apart from one another at the upper edge 40 of the shell 10. In some embodiments, the ring 46 can have at least three subsections that are spaced apart from one another at the upper edge 40 of the shell. The subsections each have two ends.Spacers are formed between the respective ends of two adjacent subsections. The spacers can in particular be located at least between adjacent expandable units 20. In other words, the subsections can each be arranged above an expandable unit 20 (seen from the expandable unit 20 in the direction of the upper edge 40). The ring sections above an expandable unit 20 can achieve a supporting effect for the shaping or shape maintenance of the expandable unit 20. In other words, a desired shape of the expandable unit 20, such as a three-dimensional curvature of the expandable unit 20, can be better maintained than without a ring section above the expandable unit 20. In addition, the subsections of the ring 46 also contribute to the simplified implantation described above.The interruptions in the ring 46 between the chambers 22 (or the respective arrangement of a subsection directly above a respective expandable unit 20) can improve the deformability of the implant 100, particularly during operation. In particular, compared to a ring 46 that has no interruptions, in particular no interruptions in the circumferential region (at the upper edge 40) between the expandable units 20, the deformability of the shell 10 or the implant can be improved. In particular, the ring 46 (or its subsections in total) can extend at least 60%, preferably at least 75%, and particularly preferably at least 90% along a circumference of the upper edge 40. An extension of 100% along the circumference of the upper edge 40 is achieved, for example, when the ring 46 has a closed structure.The ring 46 is arranged on the upper edge 46 of the shell 10 in such a way that it provides a stiffening or shaping effect for the upper edge 40. This stiffening or shaping effect also has a shaping and stiffening effect on the shell. Generally, the ring 46 can be referred to as a stiffening structure or annular stiffening structure.

[0102] The ring 46 is a separate part from the shell 10, in particular its first layer 14 and second layer 16. The ring 46 can in particular be molded onto the upper edge 40 of the shell 10. In embodiments, the ring 46 can, for example, be shaped separately (e.g., contoured). The shape of the ring 46 can, for example, be shaped such that the ring does not touch the vena cava or coronary sinus when implanted. Contact of the vena cava or coronary sinus by the shell 40 or the ring 46 could lead to tissue injury or even damage with bleeding in the vena cava or coronary sinus. The ring 46 can be shaped into a shape other than circular in order to form or reinforce a contour of the upper edge 46. The ring 46 can then be attached to the shell 10. For example, the ring 46 can be thermally connected to the shell 10, in particular its upper edge 46 or in its region."Formed" can be understood to mean that the ring 46 is brought into a shape that the ring 46 has without external force, or to which the ring 46 returns after a deformation or strives to return as soon as the external force is no longer applied. Alternatively, the ring 46 can be designed to return to its previous state after a mechanical deformation. In other words, the ring 46 can comprise a spring effect that enables reversible deformations and / or a targeted return to the state before the deformation.

[0103] The ring 46 can extend in particular along the upper edge 40 of the shell 10. In embodiments, the ring 46 can form and / or shape the upper edge 40 of the shell 10. In particularly advantageous embodiments, the ring 46 can extend at least in the region of the first recess 43 and / or the second recess 44. In particular, the ring 46 can pre-shape the recesses 43, 44 and increase the stability or dimensional accuracy in the region of the recesses 43, 44. As shown in particular in Figs. 3a, 3b, 4a, 5a and 7, the ring 46 is attached to the shell 10. For example, the ring 46 can be welded or glued to the shell 10. In particular, the ring 46 can be attached to the first layer 14. The ring 46 may be attached to the outside of the first layer 14 so that no components of the ring 46 protrude towards the heart muscle.If components of the ring 46 protrude beyond the inside of the first layer 14 towards the heart muscle, this could lead to irritation or injury to the heart muscle or to impaired function. Furthermore, components of the ring 46 protruding towards the heart could lead to mechanical stimuli that could cause cardiac arrhythmias. Alternatively, the ring 46 can be designed and attached to the shell 10 in such a way that components only protrude outwards. This prevents irritation or injury to the heart muscle and cardiac arrhythmias. The ring 46 can touch the pericardium of the heart. The pericardium is a connective tissue-like sac that surrounds the heart. Contact between the ring 46 and the pericardium cannot therefore lead to bleeding or cardiac arrhythmias. Figs. 3a, 3b, 4a and 5a show the implant without the optional structured surface explained below. However, the ring 46 can be designed as in Figs.6a and 6b, be enclosed, in particular at least partially enclosed, by a third layer 66. The third layer 66 can be connected to the first layer 14 and / or the second layer 16, in particular connected in an overlapping manner. For example, the third layer 66 can be designed as a U-shaped overlap layer, as shown by way of example in Figs. 6a and 6b. The two side legs of the U-shape can, for example, be arranged so as to overlap, in particular connected, to the first layer 14 or the second layer 16. In alternative embodiments, the ring 46 can be arranged and / or connected to the second layer 16 or to both layers 14, 16, in particular between the first layer 14 and the second layer 16.In particular, the ring 46 can be arranged, in particular fastened, in one or more regions on the first layer 14 and in one or more regions on the second layer 16 (for example in the region of the expandable units 20).

[0104] As can be seen in Figs. 6a and 6b, the ring 46 can have a circular cross-section. A round, particularly circular, cross-sectional shape can simplify manufacturing. Furthermore, the risk of injury can be reduced, particularly if a rounded upper edge is provided. In some embodiments, the ring can also have other cross-sectional shapes, such as an oval, polygonal, trapezoidal, or teardrop-shaped cross-sectional shape.

[0105] The ring 46 can be made of a plastic material. In particular, the ring 46 can be made of a solid material in cross-section. This means that the ring 46 cannot have any cavities in its cross-section. In particular, the ring 46 can be made of a plastic material. In preferred embodiments, the ring can comprise polyurethane and / or polyamide. In alternative embodiments, the ring can comprise silicone, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, and / or polypropylene.

[0106] In particularly preferred embodiments, the ring 46 can have a greater hardness than the shell 10. For example, the shell 10 can have a material with a Shore hardness D of at most 45 and the ring 46 can have a material with a Shore hardness D of at least 50. Preferably, the ring 46 can have a material with a Shore hardness D of at least 60. Particularly preferably, the ring 46 can have a material with a Shore hardness D of at least 65. In particular, the ring 46 can be made from a material with a corresponding Shore hardness D of at least 50, preferably at least 60, particularly preferably at least 65. In embodiments, the material of the ring 46 can have a Shore hardness D between 50 and 85, preferably between 55 and 80 and particularly preferably between 60 and 75, such as 65. Such hardness values ​​can achieve a good ratio between hardness or dimensional stability and deformability.The shell 10 can preferably comprise a material with a Shore hardness D of maximum 40. Particularly preferably, the shell 10 can comprise a material with a Shore hardness D of maximum 35. In particular, the shell 10 can be made from a material with a corresponding Shore hardness D of maximum 45, preferably maximum 40, particularly preferably maximum 35. In embodiments, the material of the shell 10 can comprise a Shore hardness D between 15 and 50, preferably between 20 and 45 and particularly preferably between 25 and 40, for example 30 or 35. In particular, the material of the shell 10 can comprise a Shore hardness A between 75 and 95. This can provide good compressibility during implantation and good functionality during operation after implantation.Particularly in combination with a ring 46 having a higher hardness than the shell 10, a simplified implantation can be achieved by the ring 46 while at the same time providing good functionality and dimensional stability.

[0107] The exemplary embodiments illustrated in the figures show an implant 100 with three expandable units 20 and a supply line system 200 with three fluidic supply lines 220. Each fluidic supply line 220 supplies one expandable unit 20. For better differentiation, the fluidic supply lines 220 and the expandable units 20 are identified by separate reference numerals in some figures (see Figs. 2, 3b, 5a, 7, 9a, 9b). A first expandable unit 20a can, in the implanted state, at least partially cover a left-posterior region of the heart (see Fig. 9b). Alternatively, the first expandable unit 20a can be designed and arranged to, in the implanted state, at least partially cover a left-posterior region of the heart. The first expandable unit 20a can also be referred to as a left-posterior expandable unit 20a.The first expandable unit 20a can be fluidically connected to a first fluidic supply line 220a. A second expandable unit 20b can, in the implanted state, at least partially cover a left anterior region of the heart (see Fig. 9a). Alternatively, the second expandable unit 20b can be designed and arranged to, in the implanted state, at least partially cover a left anterior region of the heart. The second expandable unit 20b can also be referred to as a left anterior expandable unit 20a. The second expandable unit 20b can be fluidically connected to a second fluidic supply line 220b. A third expandable unit 20c can, in the implanted state, at least partially cover a right region of the heart (see Fig. 9a).Alternatively, the third expandable unit 20c can be designed and arranged to at least partially cover a right region of the heart when implanted. The third expandable unit 20c can also be referred to as the right expandable unit 20c. The third expandable unit 20c can be fluidically connected to a third fluidic supply line 220c.

[0108] The terms anterior and posterior refer to areas or directions relative to a patient (or their heart or the implanted device). Anterior refers to the front of the patient (e.g., abdomen), and posterior refers to the back or rear areas of the patient (toward the back). In relation to the heart or implant, anterior means in front of the heart toward the front of the patient, and posterior means behind the heart toward the back.

[0109] The expandable units 20 can be expanded by filling them with a fluid. In embodiments, the fluid used to fill the expandable unit 20 or its chamber 22 can be liquids, gases, or solids (such as nanoparticle mixtures), or mixtures of liquids and / or gases and / or solids.

[0110] In particular, the expandable unit 20 can be adjustable between a first configuration and a second configuration. More precisely, the expandable unit 20 can be adjustable between a non-expanded configuration and an expanded configuration. In this regard, Figs. 6a and 6b show two different configurations by way of example. Fig. 6a shows the expandable unit 20 in a non-expanded configuration. Fig. 6b shows the expandable unit 20 in an expanded configuration. Clearly visible in Fig. 6b and represented by the oppositely oriented arrows, the expandable unit 20 can be expanded towards the inside 11 of the shell 10 and towards the outside 12 of the shell 10 when adjusted from the non-expanded configuration to the expanded configuration. This can be achieved, for example, by forming the chamber 22 of the expandable unit 20 by the two layers.This not only has an advantageous effect on the ventricle, but also allows for simple support on the pericardium.

[0111] In embodiments as shown in the simplified representations of Figs. 20a, 20b and 20c, the at least one expandable unit 20 can comprise a first circular corrugation 26 and a second circular corrugation 26. The first corrugation 26 can surround the second corrugation 26, as shown. In other embodiments, more or fewer than two corrugations 26 can be provided in the at least one expandable unit 20. Alternatively, the expandable unit 20 can comprise at least one circular corrugation 26. In the example shown, the at least one circular corrugation 26 is arranged in the first layer 14. Alternatively, the at least one circular corrugation 26 could be arranged in the second layer 16, in particular when the second layer 16 is arranged on the inner side 11 of the shell 10.In other words, the at least one circular corrugation 26 is arranged in the layer 14, 16, which is arranged on the inner side 11 of the shell 10. In addition to the expandable unit 20 referenced by the reference numeral 20, an expandable unit 20 arranged to the right of it, with, for example, two circular corrugations 26, is shown by way of example. It should be understood that all, two, or even just one expandable unit 20 can have one or more circular corrugations 26. The number of circular corrugations 26 can vary between the expandable units 20. For example, one expandable unit 20 can comprise two circular corrugations 26 and another expandable unit 20 can comprise only one circular corrugation 26. An expandable unit 20 can also comprise more than two circular corrugations 26.

[0112] As is particularly evident in the representation of the implant 100 in a non-expanded state shown in Fig. 20a, the at least one corrugation 26 can be embossed into the first layer 14. This also applies analogously to the above explanations for the second layer 16 if it is located on the inner side 11 of the shell 10. In particular, the circular corrugation 26 can be introduced into the layer 14, 16 as an annular embossing. The term "circular" in connection with the circular corrugation 26 particularly also encompasses shapes that are not circular with a constant radius, but also oval shapes (with or without an axis of symmetry) or polygonal shapes (also with rounded edges). By providing at least one circular corrugation 26, an increase in the volume of the chamber 22 can be enabled compared to an expandable unit 20 without corrugations.In addition, a more targeted expansion toward the inner side 11 (i.e., toward the heart) can be enabled. As shown particularly in Fig. 20b, the circular corrugation 26 can be stretched in the expanded state.

[0113] Fig. 20c shows a highly simplified schematic representation of a comparison of the expandable units 20 of the implants 100 of Figs. 6a and 20a. This shows that the at least one circular corrugation 26 is designed to increase the volume of the chamber 22 compared to an expandable unit 20 without corrugation. An example of an expandable unit 20.1 with two circular corrugations 26 in the first layer 14.1 is shown in the expanded state. The same Fig. 20c shows an expandable unit 20.2 without a circular corrugation 26 in the first layer 14.2. As clearly evident from Fig. 20c, the volume of the chamber 22 of the expandable unit 20.1 with corrugations 26 is increased compared to the volume of the chamber 22 of the expandable unit 20.2 without corrugations 26.

[0114] Due to the at least one corrugation 26, the at least one expandable unit 20 can be expanded more towards an inner side 11 of the shell 10 than towards an outer side 12 of the shell 10 when adjusting from the non-expanded configuration to the expanded configuration.

[0115] As can be seen in particular in Fig. 20a, the at least one corrugation (26) can be convex on an inner side 11 of the shell 10. In other words, the at least one corrugation 26 is concave on an inner side of the chamber 22. Viewed in cross-section, a corrugation 26 can therefore comprise at least one corrugation crest (for example, semicircular in cross-section). In embodiments, a corrugation 26 can also comprise a corrugation crest and one or two corrugation troughs (not shown; the figures, in particular Fig. 20a, show two spaced-apart circular corrugations 26, which are designed as corrugation crests). A corrugation trough can be understood in particular as a semicircular shape, viewed in cross-section, which has a curvature opposite to the corrugation crest (for example, convex on an inner side 11 of the shell). The one or more corrugation troughs can also be embossed into the layer 14, 16 (not shown).

[0116] In the embodiment example of Figs. 20a, 20b, 20c, the at least one corrugation 26 is arranged at a distance from the closed line 15. Alternatively, in embodiments with multiple corrugations 26 as shown, the corrugation 26 arranged closest to the closed line 15 (also referred to as the outermost corrugation 26 or first corrugation 26) can be arranged at a distance from the closed line 15. Alternatively, the corrugation 26 can also be arranged directly adjacent to the closed line 15. A distance 27 between the at least one corrugation 26 and the closed line 15 can be between 1 mm and 20 mm, in particular between 2 mm and 10 mm. In particular, the distance 27 between the at least one corrugation 26 and the closed line 15 can be constant (seen along the course of the closed line 15). In particular, distances with a tolerance of + / - 0.5mm can be considered constant.

[0117] A width 26a of the at least one corrugation 26 in the non-expanded state can be 1 mm to 15 mm, in particular 2 mm to 10 mm (see Fig. 20a). The two circular corrugations 26 in the example of Fig. 20a are arranged at a distance from one another. The first corrugation 26 can be spaced from the second (inner) corrugation 26 by a distance that lies in the range of the width 26a described above. In particular, the two corrugations 26 can be constantly spaced from one another. Alternatively, the two corrugations 26 can also be arranged directly adjacent to one another. In embodiments, the expandable unit 20 can also comprise three or more circular corrugations 26 that are arranged directly adjacent to one another or at a distance from one another.

[0118] In advantageous embodiments, the fluidic supply line 220 is connected to the expandable unit 20 via a connecting piece 24 (see in particular Figs. 4a, 5a, 6a, 6b, 9a, 9b). Alternatively, the expandable unit 20 can comprise a connecting piece 24 for connection to the fluidic supply line 220. For reasons of clarity, the connecting pieces 24 are not shown in some figures in order to better illustrate the orientation and arrangement of the respective fluidic supply lines 220. In alternative embodiments, however, it would also be conceivable to connect one or more of the fluidic supply lines 220 directly to the chamber, for example, through an opening in the first or second layer or therebetween. The use of connecting pieces 24, however, has the advantage that the guidance of the fluidic supply lines 220 can be improved and the risk of damage to the expandable units 20 can be reduced.

[0119] The respective connection pieces can also be identified with specific reference numerals analogous to the fluidic supply lines 220a, 220b, 220c, as shown in particular in Figs. 9a and 9b. This means that the implant 100 can comprise a first connection piece 24a, a second connection piece 24b and / or a third connection piece 24c. In detail, the first expandable unit 20a can comprise a first connection piece 24a. The second expandable unit 20b can comprise a second connection piece 24b. The third expandable unit 20c can comprise a third connection piece 24c. The first fluidic supply line 220a is connected to the first connection piece 24a on the first expandable unit 20a. The second fluidic supply line 220b is connected to the second connection piece 24b on the second expandable unit 20b.The third fluidic supply line 220c is connected to the third connection piece 24c on the third expandable unit 20c.

[0120] The connecting piece 24 can comprise an inlet into the chamber 22 and an outlet into the fluidic supply line 220. In particular, the connecting piece 24 can comprise an outlet that is inclined relative to the outer surface 12 of the shell 10 in order to guide the fluidic supply line 220 laterally along the shell 10 (see in particular Figs. 6a and 6b). For example, the connecting piece 24 can comprise a bend. In other words, the connecting piece 24 can define a channel that extends from the inlet into the chamber 22 to the outlet into the fluidic supply line 220. The channel can be straight or curved. In embodiments, an angle between the inlet into the chamber 22 and the outlet towards the supply line can, for example, have a value between 0° and 90°. The inlet into the chamber 22, in particular a cross-sectional area of ​​the inlet, can be parallel to a chamber surface, e.g.On the outer surface 12 of the shell 10, (see Figs. 6a and 6b), whereby the angle between the inlet and the outlet at the connection piece would be 90°. In particular, in such an embodiment, the angle between the inlet and the outlet can be approximately 90°, as shown in Figs. 6a and 6b. In embodiments, the angle between the inlet and the outlet can be greater than 0° and preferably comprise a value between 60° and 90°. As a result, the supply line 220 can be guided laterally away from the chamber 22 or from the outlet in the proximal direction 2b. In embodiments, the inlet can be inclined to the chamber (e.g., a tubular section penetrating obliquely into chamber 22); in particular, the angle between the inlet and the outlet can then also have a value of 0°.In other words, in such configurations, the connecting piece can have a channel that is inclined relative to the outer surface, which can also be straight. A diagonally penetrating, straight channel of the connecting piece 24 can facilitate a more favorable flow of fluid into the chamber.

[0121] Alternatively, and as can be clearly seen from Fig. 2, for example, the connecting piece 24 can be designed to receive the fluidic supply line 220 parallel to the outer surface 12 of the shell 10 or inclined away from the outer surface 12. Even if the connecting piece is not shown in Fig. 2, it can be clearly seen from the figure that, for example, the fluidic supply line 220c is received slightly inclined away from the outer surface 12. The angle between the inlet and outlet at the connecting piece can be, for example, 75°. In this exemplary embodiment, the fluidic supply line 220a can be received by the connecting piece in such a way that the fluidic supply line 220a is not subject to any tight bends near the connecting piece and can be received by the connecting piece as straight as possible.In particular, the connecting piece 24 can be designed to receive the fluidic supply line 220 at an angle between 0° and 30°, preferably between 0° and 15°, relative to an outer surface of the shell 10.

[0122] It should be understood that the design of the connecting pieces 24 can be the same for all existing connecting pieces 24, but this is not required. For example, one or more connecting pieces 24 can have different designs.

[0123] In specific exemplary embodiments with multiple expandable units 20, the respective connecting ports 24 can be configured differently. For example, the connecting port 24c of the right expandable unit 20c can be configured to receive the fluidic supply line 220c at an angle of 15° or more to an outer surface of the shell 10. The connecting port 24a of the left posterior expandable unit 20a can be configured to receive the fluidic supply line 220a at an angle of less than 15° to an outer surface of the shell 10, in particular 0° to 5°. The connecting port 24b of the left anterior expandable unit 20b can be configured to receive the fluidic supply line 220b at an angle of less than 15° to an outer surface of the shell 10, in particular 0° to 5°.For the left-hand expandable units 20a, 20b, the angles of 0° to 5° can be particularly advantageous, since the fluidic supply lines 220a, 220b conform better to the implant 100 in the circumferential direction than a more inclined receiving / discharging of the supply lines. A circumferential direction can be understood as a direction running transversely between the upper edge 40 and the lower opening 48. In particular, it can be understood as a direction running orthogonally between an imaginary line between the upper edge 40 and the lower opening 48. For example, a horizontal direction in Fig. 4a can be referred to as the circumferential direction of the implant 100. For example, a direction running parallel to the upper edge 40 can be understood as the circumferential direction.In contrast, in the right expandable unit 20c, the exit of the supply system 200 from the pericardium and (in the proximal direction 2b) away from the implant 100 at an angle is advantageous (see also explanations further below regarding the supply system 200).

[0124] As can be seen, for example, with regard to the fluidic supply line 220a in Fig. 2 or the fluidic supply line 220 in Figs. 6a and 6b, the connecting piece 24 can be designed to accommodate the fluidic supply line 220 at a distance from the outer surface 12. In embodiments, the spacing in the normal direction to the outer surface 12 of the shell 10 can be 0.5 mm to 2.5 mm. In particular, the spacing in the normal direction to the outer surface 12 of the shell 10 can be 1 mm to 2 mm. Preferably, the spacing in the normal direction to the outer surface 12 of the shell 10 can be at least 1.5 mm. Particularly preferably, the spacing in the normal direction to the outer surface 12 of the shell 10 can be 1.5 mm or 1.5 mm + / - 0.25 mm. The spacing can be understood as the distance between the outer surface 12 and the fluidic supply line 220 in the region of the outlet of the connection piece 24.By spacing the supply line connection in the connection piece 24 from the chamber surface, contact between the supply line and the chamber 33 can be prevented or at least reduced when the chamber 22 (or the expandable unit 20) moves. This can reduce the risk of damage to the chamber 22 or the expandable unit 20. If this spacing is not maintained, the supply line sections 220a, 220b, 220c and the outer surfaces of the expandable units 20a, 20b, 20c could touch and rub against each other with each heartbeat, which could cause damage to the expandable units or the supply line sections and lead to the implant no longer being able to function properly due to subsequent leaks.

[0125] As can be seen in Fig. 4a, for example, the connecting piece 24 can be fluidically connected to the chamber 22 at a distance from the closed line 15. In particular, the connecting piece 24 can be arranged at a distance from the closed line 15 towards the interior of the chamber. In some embodiments, the connecting piece 24 can be arranged centrally towards the interior of the chamber at a distance from the closed line 15. In embodiments, the connecting piece 24 can be designed to receive the fluidic supply line 220 from or in a predefined direction between the upper edge 40 of the shell 10 and the lower opening 48. Viewed from the outside 12 of the respective expandable unit 20, the upper edge 40, as shown in Fig. 4a, is arranged at the top and the lower opening 48, as shown in Fig.4a, is arranged at the bottom, the respective connecting piece 24 can be designed and arranged to receive the respective fluidic supply line 220 from a 6 to 12 o'clock position or direction. In this case, the upper edge 40, viewed from the outside on the outer surface 12 of the implant, can be viewed as being at 12 o'clock, the lower opening 48 can be viewed as being at 6 o'clock, and the connecting piece 24 can be viewed as being central to the positions or directions. In particular, the most proximal fluidic supply line 220c can be received from a 9 to 12 o'clock position or direction. The two more distal fluidic supply lines 220a, 220b can be received from a 6 to 9 o'clock position or direction. In particular, the connection piece 24c (or in particular its outlet) of the right expandable unit 20c can be arranged between 9 and 12 o'clock, or the associated fluidic supply line 220c can be received or discharged in a region between 9 and 12 o'clock.The connecting piece 24a (or in particular its outlet) of the left-posterior expandable unit 20a and / or the connecting piece 24b (or in particular its outlet) of the left-anterior expandable unit 20b can be arranged in particular between 6 and 9 o'clock, or can receive or discharge the associated fluidic supply line 220a, 220b in a region between 6 and 9 o'clock. This allows the fluidic supply lines 220a, 220b of the first expandable unit 20a and the second expandable unit 20b to be directed away from the adjacent expandable units in a targeted manner, in particular by routing them around them. The fluidic supply line 220c from the right expandable unit 20c can be routed through the patient's body above the diaphragm. This provides the advantage of reducing or preventing any impairment of the diaphragm's freedom of movement.If the lead 200a or lead sections were to be routed through the diaphragm very close to the implant 100 or very close to the heart, movements of the diaphragm could be transmitted too strongly to the lead 200a or lead sections and the implant, which in the worst case could lead to a displacement of the implant relative to the heart and the implant would subsequently no longer be positioned correctly.

[0126] As already mentioned, the connecting piece 24 can be arranged at a distance from the closed line 15 in the direction of the chamber interior. In particular, the connecting piece 24 can be arranged between the closed line 15 and a center formed relative to the closed line, as viewed from the outer side 12. In some embodiments, the connecting piece 24 can be spaced from the center in the direction toward the closed line 15 from which the respective connecting piece 24 receives the associated fluidic supply line 220. For example, the connecting piece 24 from Fig. 4a can be spaced from the center to the closed line 15 in the 7 to 8 o'clock direction.

[0127] As can be seen in Fig. 5a, for example, the expandable units 20 are arranged at a distance from one another. In particular, the expandable units 20 are spaced apart in the circumferential direction. Even if the implant 100 illustrated by way of example comprises three spaced-apart expandable units 20, in other embodiments the implant 100 may comprise more or fewer than three expandable units 20. However, the implant 100 comprises at least one expandable unit 20. In embodiments, the implant 100 may comprise a plurality of expandable units 20, in particular two, three, four, five, or six expandable units 20.

[0128] As can be seen in particular from Fig. 3b, two electrodes 31, 32 are arranged between each two adjacent expandable units 20. This means that the exemplary embodiment of the implant 100 from the figures comprises six electrodes 31, 32. In alternative embodiments, the implant 100 can also comprise more or fewer than six electrodes. In particular, more or fewer than two electrodes 31, 32 can be arranged between each two expandable units 20. For example, only one, none, three, or more than three electrodes can be arranged between two adjacent expandable units 20. The electrodes 31, 32 do not necessarily have to be arranged between adjacent expandable units 20.In alternative embodiments, one or more electrodes 31, 32 can also be arranged above an expandable unit 20 (toward the upper edge 40) and / or below an expandable unit 20 (toward the lower opening 48). However, with regard to the functionality and measurement quality of, for example, an ECG measurement, a larger number of spatially distributed electrodes is advantageous. This can be achieved in particular by the electrodes 31, 32 arranged between the expandable units 20.

[0129] In advantageous embodiments, as particularly illustrated in Figs. 3a, 3b, 4a, 4b, 5a, 5b, 6a, 6b, and 7, the implant 100 can comprise at least one electrode ridge 30 to which at least one electrode 31, 32 is attached. The electrode ridge 30 can be arranged on the outer surface 12 of the shell. More specifically, the exemplary implant 100 comprises three electrode ridges 30 arranged spaced apart from one another on the shell 10. In particular, the electrode ridges 30 can be arranged circumferentially spaced apart on the outer side of the shell 10. In embodiments, the electrode ridges 30 can each be arranged between two adjacent expandable units 20 (see Fig. 3b).

[0130] Even if it were conceivable that only one electrode 31, 32 were attached to the electrode web 30, in preferred embodiments as shown in the figures, two electrodes 31, 32—a first electrode 31 and a second electrode 32—are attached to the electrode web 30. The electrodes 31, 32 can be attached to the respective electrode web 30 at a distance from one another. For example, the electrode web 30 can have a first end region 34 and a second end region 36 opposite the first end region 32 (see in particular Figs. 8a and 8b). The first electrode 31 can be arranged in the first end region 34. The second electrode 32 can be arranged in the second end region 36. Alternatively, the two electrodes 31, 32 can be arranged in opposite end regions 34, 36 of the electrode web 30. This can improve the quality of the ECG signals.In addition, by increasing the distance between electrode webs 30 or the electrodes 31, 32 and distributing them both in height between an upper edge 40 and a lower opening 48 and in the circumferential direction, the three-dimensional characteristics of the electrical excitation can be calculated and represented as a 3D vector. The greater the distances between the electrodes 31, 32, the greater the potential differences and the more accurately the three-dimensional characteristics of the electrical excitation and the vector can be calculated. A larger number of electrodes 31, 32 used and their spatial distribution can lead to a more precise and reliable calculation of the vector. In addition, a larger number of electrodes 31, 32 (for example, six or more electrodes 31, 32) enables improved defibrillation and / or pacemaker function.

[0131] The electrodes 31, 32 each have an active side 31a, 32a with which signals can be received or transmitted (see Figs. 6a, 6b and 8a). The electrodes 31, 32 are arranged on the electrode web 30 such that the active side 31a, 32a is directed towards the inner side 11 of the shell 10. In other words, the electrodes 31, 32 are arranged on the electrode web 30 such that the active side 31a, 32a is oriented in the same way as the inner surface 11 of the shell 10 (see Fig. 6a). An opposite region of the electrode 31, 32 (towards the outer side 12 of the shell 10; the side of the shell 10 facing away from the heart) can be insulated, in particular electrically insulated. For example, the electrode 31, 32 can be embedded in the electrode web 30 such that the active side 31a, 32a of the electrode 31, 32 protrudes from the electrode web 30 (see Fig. 6a). This can improve the quality of the desired ECG signals.An improvement in ECG signal quality in this case can be due to a reduced distance from the heart muscle to the active side 31a, 32a of the electrode 21, 32. Furthermore, the protrusion of the active sides 31a, 32a of the electrode 31, 32 from the electrode web 30 can result in direct contact between the active sides 31a, 32a of the electrodes 31, 32 and the heart muscle. This can be particularly advantageous immediately after implantation of the implant 100, since at such a time the active sides 31a, 32a of the electrodes 31, 32 may still be insufficiently wetted by body fluid or tissue, and the protrusion of the active sides 31a, 32a establishes contact with the heart muscle. In particular, the electrode 31, 32 can be electrically insulated except for the active side 31a, 32a. This prevents the electrode on the outside from measuring an electrical potential.An additional measurement of the electrical potential on the outside could lead to different signal propagation times for the desired electrical signals, such as the R-wave or T-wave of the ECG. This could result in wider R-waves and T-waves and / or broaden all signals. Broadening of the R-waves and T-waves can lead to misinterpretations or make the ECG unusable. By isolating the outside, however, the signal measurement can be directed and the desired ECG signals can be recorded more sharply. Furthermore, by isolating the outside, a pacemaker function or defibrillation via electrodes 31, 32 could be directed inwards.

[0132] In embodiments, the shell 10 can have a passage 41, 42 for each electrode 31, 32 to an inner side 11 of the implant 100 (see in particular Figs. 6a, 6b). The passage 41, 42 can be arranged and configured such that the active side 31a, 32a of at least one electrode 31, 32 protrudes through the passage 41, 42 to the inner side 11. In the present embodiment, the shell 10 can therefore have two passages 41, 42 for each electrode web 30. In other words, the respective passages 41, 42 and the placement of the electrodes 31, 32 in the electrode web 30 can be coordinated with one another. This means that, depending on the arrangement of the two electrodes 31, 32 in the electrode web 30, two passages 41, 42, one each for an electrode 31, 32, can be provided in the implant 100 or the shell 10.In some embodiments, the electrode 31, 32 can extend into or through the respective passage 41, 42. The active sides can be flush with the inner surface 11 of the implant 100, which reduces the risk of injury. If the active sides 31a, 32a protrude too far beyond the inner surface 11 of the implant 100, this can lead to injury to the heart muscle.

[0133] In embodiments, the electrode web 30 can be attached to the outer side 12 of the shell 10. In embodiments, the electrode web 30 can be arranged in a correspondingly formed recess on the outer side of the shell 10. In particular, the recess can be arranged at a predefined position of the implant 100. This can ensure or simplify the intended placement of the electrode web 30 or the electrodes 31, 32 attached thereto. The recess can be formed, for example, by omitting a structuring in an area on the outer side 12 of the shell 10. The electrode web 30 can be arranged on the shell 10 such that a longitudinal extension of the electrode web 30 is arranged substantially orthogonal to the upper edge 40 of the shell 10.Alternatively, the electrode web 30 can be arranged on the shell 10 such that a longitudinal extent of the electrode web 30 is arranged substantially orthogonal to the circumferential direction. In some embodiments, "substantially orthogonal" can comprise an inclination of 90° + / - 15° relative to a profile of the upper edge 40 of the shell 10 and / or relative to the circumferential direction. The longitudinal extent can be understood as the dimension of the electrode web 30 that extends from the first end region 34 to the second end region 36. In other words, the electrode web 30 can be arranged on the shell 10 such that a first of the two electrodes 31, 32 is located as close as possible to the upper edge 40 of the shell 10 and a second of the two electrodes 31, 32 is located as close as possible to the lower opening 48.

[0134] As can be seen particularly in Figs. 8a and 8b, the two end regions 34, 36 can be connected to one another via a waist 35. The waist 35 can improve the flexibility and adaptability of the electrode bridge 30. Furthermore, the electrode bridge 30 or its waist 35 can protect electrical leads 37, 38 from intracorporeal damage. Furthermore, a waist 35 of the electrode bridge can prevent or at least limit or impair the area of ​​the adjacent expandable units 20.

[0135] The first electrode 31 and the second electrode 32 can be surrounded by a material to form the electrode web 30. In particular, the electrodes 31, 32 can be overmolded with a material to form the electrode web 30. An electrical supply line 37, 38 of the supply line system 200, which leads to the respective electrode 31, 32, can also be at least partially overmolded and / or embedded in the electrode web 30. Alternatively or additionally, the electrode web 30 can be provided as a prefabricated element, and the at least one electrode 31, 32 and / or the electrical supply line 37, 38 can be at least partially inserted into the electrode web 30, optionally clamped or glued in. The electrode web 30 can comprise a plastic material. In particular, the electrode web 30 can comprise polyurethane, epoxy, silicone, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polyamide, and / or polypropylene. As shown particularly in Figs.As shown in Figs. 3a, 3b, 8a, and 8b, the electrical leads 37, 38 to the two electrodes 31, 32 can have a common lead section 39. The common lead section 39 can be separated in the region of the electrode web 30, in particular within the electrode web 30 (see Figs. 8a and 8b). In some embodiments, the electrode web 30 can further comprise a strain relief for an electrical lead 37, 38 to the at least one electrode 31, 32. In the examples in Figs. 8a and 8b, the strain relief is formed by an arcuate course of the electrical lead 37, 38 within the electrode web 30. The curved shape means that when tensile load is applied to the supply lines, the load does not act directly on the connection point of the supply lines 37, 38 to the electrodes 31, 32, which can potentially lead to a breakage of the connection point.A potential tensile load can thus initially be absorbed or at least reduced by stretching the supply lines 37, 38 and friction between the supply lines 37, 38 and the electrode web 30. Alternatively or in addition to the curved path, mechanical strain relief can be provided by a separate mechanical tension cable. The mechanical tension cable can, for example, be shorter than the electrical supply line 37, 38, so that a tensile force is absorbed first by the mechanical tension cable.

[0136] In advantageous embodiments, the shell 10 can comprise a conductive region, at least in sections. The conductive region can have a perforation 50 and / or a plurality of conductive elements in order to establish a fluidic and / or conductive connection between the inner side 11 of the shell 10 and the outer side 12 of the shell 10. In the exemplary embodiments shown in Figs. 4b, 5b, 6a, and 6b, the conductive region comprises a perforation 50 with a plurality of passages 52 between the inner side 11 and the outer side 12 of the shell 10. In particular, this can improve electrical conductivity through the shell 10, which in turn can improve defibrillability and surface ECG signal quality. In this regard, Fig. 10 shows a diagram on which a voltage axis 70b in microvolts [pV] is plotted over a time axis 70a in seconds [s]. Two comparison signals 72, 74 are compared.A highly attenuated surface ECG signal 74 is achieved in comparison to an improved surface ECG signal 72 with reduced attenuation, which is achieved by an implant 100 with the conductive region described here. The conductive section improves the electrical conductivity through the shell 10. Without the perforation 50, the shell 10, if it were made of plastic, for example, would have an insulating effect, and the ECG signal could only be measured in an attenuated manner at the surface (e.g., a smaller amplitude and / or a slightly stretched morphology). The passages 52 ensure that the ECG can be measured as with a standard surface ECG. This can prevent or at least reduce changes in amplitude or morphology. In addition to the perforation 50, the lower opening 48 at the apex of the heart, which may be present depending on the design, can also improve the defibrillability of the heart in the implanted state.In addition, the passages 52 of the perforation can also reduce the differences in signal propagation discussed above with respect to the electrodes 31, 32, since the electrical signal no longer has to flow around the implant 100, as compared to an insulating shell.

[0137] In embodiments, the perforation 50 can comprise at least 5, at least 10, at least 15 or at least 30 perforation passages 52. In embodiments, the perforation 50 can comprise a maximum of 150, a maximum of 120, a maximum of 100 or a maximum of 80 perforation passages 52. In particular, the perforation 50 can comprise a number of perforation passages 52 between each of the aforementioned minimum numbers and each of the aforementioned maximum numbers. For example, the perforation 50 can comprise between 5 and 150 perforation passages 52. In embodiments, the passages 52 of the perforation 50 can be circular, as shown in the figures. In alternative embodiments, the passages 52 can be oval, elongated and / or polygonal. In particular, the passages 52 can be different or identical, for example with regard to shape and / or size.In advantageous embodiments, the passages 52 can be identical and circular. This allows the passages 52 to be easily manufactured and at the same time offer a good yield in terms of their conductivity potential (e.g., compared to linear, elongated shapes). In embodiments, the passages 52 of the perforation 50 can have a diameter between 0.1 mm and 5 mm. Preferably, the passages 52 of the perforation 50 can have a diameter between 0.5 mm and 2.5 mm. Particularly preferably, the passages 52 of the perforation 50 can have a diameter between 0.75 and 1.5 mm. For example, the perforation passages 52 can have a diameter of 1 mm + / - 0.25 mm. In embodiments, the perforation passages 52 can have different or identical dimensions, in particular diameters, and / or geometries.In embodiments, the perforation 50 can be arranged in regions of the shell 10 adjacent to the electrode web 30 and / or to the at least one expandable unit 20. Alternatively, the perforation 50 can not be arranged in the region of the electrode webs 30 and / or the expandable units 20. In particular, the perforation 50 can be arranged in regions of the shell 10 with only one layer 14, 16. In embodiments, the perforation 50 can, for example, have a surface area of ​​0.1% to 20%, in particular 0.5% to 10%, and preferably 1% to 5%, relative to an implant 100 without a perforation 50, relative to a total surface area on the outer side 12 between the upper edge 40 and the lower opening 48. This ensures that the perforation 50 only covers a specific portion of the shell 10, whereby the stability or structural function of the shell 10 is not impaired.

[0138] The perforation 50 can be provided in the shell 10 independently of or dependent on the production of the shell 10. For example, the perforation 50 can be introduced into the shell 10 by punching out the passages 52. If the shell 10 is produced, for example, by thermoforming, the perforation 50 can be introduced into the shell before and / or after thermoforming. Introducing the perforation 50 before thermoforming has the advantage of easier production, since only the layered or flat base material of the shell 10 needs to be perforated. Introducing the perforation 50 after thermoforming has the advantage that the passages 52 of the perforation 50 can be introduced with greater positional and shape precision with regard to the thermoformed shell geometry. The perforation 50 can also be partially formed during thermoforming or its passages 52 can be enlarged.For example, the base material of the shell 10 can be perforated or pierced with small passages prior to thermoforming (e.g., with a needle-like perforating device), whereby these small passages are at least widened by stretching during thermoforming to form the passages 52. Even when using other manufacturing processes for the shell 10, the perforation 50 can be introduced into the shell before (or during) or after the manufacture / shaping of the shell 10. For example, (injection) molds used in casting or injection molding can have geometries corresponding to the passages 52 or the perforation 50. As described above and shown in Figs. 4b, 5b, and 6a-b, the perforations 50 are not evenly distributed over the entire shell 10, but are provided only in locations that allow this. This results in an irregular distribution of the perforations 50.This distinguishes the perforations 50 from fabric- and mesh-like constructs, in which the fabric and mesh openings are generally evenly distributed. Unlike mesh- and fabric-like constructs, the described perforations 50 and their passages 52 are preferably dimensionally stable, meaning they do not change their shape. Mesh and fabric structures, on the other hand, have variable openings.

[0139] In some embodiments, as in the schematically simplified representations of Figs. 21 to 30, the shell 10 can comprise an expansion arrangement 54. The expansion arrangement 54 is arranged between two adjacent expandable units 20. In particular, the shell 10 can comprise three expansion arrangements 54. One of the three expansion arrangements 54 can be arranged between two adjacent expandable units 20. As a result, an expansion arrangement 54 is arranged between every two adjacent expandable units 20. In particular, the expansion arrangement 54 can be designed to reduce restriction. In this context, a “restriction reduction” is to be understood as a reduction of a geometric restriction of the heart surrounded by the implant 100. By reducing restriction, a certain expansion of the implant 100 or a growth of the implant 100, in particular in the circumferential direction, can be enabled orbe improved compared to an implant 100 without the expansion arrangement. An expansion of the material can be both an elongation of the shell material (positive expansion) and a compression of the shell (negative expansion). Alternatively, the expansion arrangement enables increased deformability or elasticity compared to a shell 10 without the expansion arrangement 54. This makes it possible to achieve an adaptability of the shell 10 to changes in size (reduction or enlargement) of the heart during operation (in particular with regard to daily fluctuations). The expansion arrangement can in particular be provided as an alternative to the perforation 50 mentioned above. In some embodiments, however, a perforation 50 can also be provided in addition to the expansion arrangement 54. In such cases, the perforation 50 can be arranged in regions of the shell 10 in which the expansion arrangement 54 is not located.Exemplary embodiments of the expansion arrangement 54 are shown in Figs. 21 to 30. The expansion arrangement 54 comprises one or more cutouts 55 and / or cuts 56 that provide passages between the inner side 11 of the shell 10 and the outer side 12 of the shell 10. In this context, a cutout 55 can be understood as a flat passage, and a cutout 56 as a slit- or line-shaped passage.

[0140] Fig. 24 shows an exemplary embodiment of the expansion arrangement 54 with a single cutout 55. The cutout 55 extends longitudinally orthogonal to the circumferential direction between two adjacent expandable units 20. Such a configuration can provide a very high deformability of the shell 10.

[0141] Figs. 21, 22, 23, 25, 26 and 28, on the other hand, show embodiments of the expansion arrangement 54 with a plurality of cutouts 55. Webs are formed between the plurality of cutouts 55. The webs extend in particular in the circumferential direction. The webs between the cutouts 55 can provide a certain rigidity that counteracts excessive deformability. The number, dimensioning and arrangement of the cutouts 55 and webs can thus enable individual patient adaptation of the implant. Figs. 21 and 22 show, for example, two cutouts 55 spaced orthogonally to the circumferential direction, between each of which a web is formed. The cutouts 55 in Fig. 21 are larger than those in Fig. 22. Thus, the embodiment in Fig. 21 can provide greater deformability than the embodiment in Fig. 22. In particular, the extension of the cutouts 55 of Fig.21 in a direction orthogonal to the circumferential direction. Thus, greater deformability of the shell 10 can be provided over a larger area orthogonal to the circumferential direction. The embodiment of Fig. 23, in comparison to the examples of Figs. 21 and 22, has three cutouts 55 spaced orthogonally to the circumferential direction, between each of which a web is formed. In other words, the expansion arrangement 54 of Fig. 23 has three cutouts 55 and two webs. The middle cutout 55 can provide deformability in a central area between the two outer cutouts. Similarly, the expansion arrangement 54 of Fig. 25, for example, has five cutouts 55 and four webs. Compared to the embodiment of Fig. 23, a more even distribution of extensibility can be provided by the expansion arrangement of Fig. 25. As in the example of Fig.26, the expansion arrangement 54 can also have cutouts.

[0142] 55, which are spaced apart from one another in the circumferential direction. This provides webs orthogonal to the circumferential direction in the shell 10. In certain embodiments, the expansion arrangement 54 may also include webs that are at least partially oblique to the circumferential direction (see, for example, Figs. 29 to 30).

[0143] The exemplary expansion assembly 54 of Fig. 28 includes cutouts 55 that have a zigzag shape extending in the circumferential direction. This can provide a spring effect. As further shown in Fig. 28, the cutouts 55 of the expansion assembly 54 can be configured differently. For example, zigzag-shaped cutouts 55 can be included with non-zigzag-shaped cutouts 55 in the expansion assembly 54.

[0144] Similarly, the expansion arrangement 54 of Fig. 27 comprises a plurality of cuts 56 having a zigzag shape extending in the circumferential direction. The expansion arrangement 54 of Fig. 29 comprises cuts 56 with wave-like sections that form a wave-like pattern. The exemplary expansion arrangement 54 of Fig. 28 comprises a plurality of cuts 56 that are Y-shaped. The Y-shaped cuts 56 are arranged in at least two rows and are offset. As can be seen from Fig. 28, the Y-shaped cuts overlap.

[0145] 56 of a row with the Y-shaped cuts 56 of an adjacent row. This can also create a spring effect similar to the design of the zigzag-shaped cuts 56.

[0146] According to the above exemplary embodiments, an expansion arrangement 54 can be understood as an arrangement which, in particular through the arrangement, orientation and dimensioning of the cutouts 55 and / or cuts 56, increases an extensibility of the shell 10 which is provided by the material property of the shell 10 without an expansion arrangement.

[0147] In embodiments, the one or more cutouts 55 of the expansion arrangement 54 can each have an area proportion of 0.5% to 10%, in particular 1% to 8%, and preferably 2% to 5%, relative to a total area on the outer side 12 between the upper edge (40) and the lower opening 48. In embodiments, the one or more cutouts 55 and / or cuts 56 can be at least partially covered by an expansion layer. The expansion layer has a higher elasticity than the layer 14, 16 surrounding the one or more cutouts 55 and / or cuts 56. In the context of the present disclosure, an expansion layer can be understood as a layer that has a higher elasticity than the first layer 14 and the second layer 16 of the shell 10.For example, the expansion layer can be made of a material that has a higher elasticity than a material of the first layer 14 and / or a material of the second layer 16. Alternatively or additionally, the expansion layer can have a smaller layer thickness than the first layer 14 and / or the second layer 16. The expansion layer can be attached to the shell 10, for example, by a thermal joining process (e.g., welding process) or chemical process (e.g., adhesive process).

[0148] In embodiments, the implant 100 can have a structured surface 60 that promotes the ingrowth of cells, in particular macrophages and / or fibroblasts. An exemplary embodiment of the structured surface 60 is shown in Figs. 4b and 5b, respectively. In comparison, Figs. 4a and 5a show the same implant 100 without the structured surface 60. Furthermore, the perforation 50 is also not shown in Figs. 4a and 5a. Nevertheless, it should be understood that the perforation 50 and the structured surface 60 can be included by the implant 100 independently of one another or not. The term “ingrowth,” particularly with regard to macrophages and fibroblasts, can also include migration or the generation of connective tissue in this area. The structured surface 60 can, for example, be a foamed or pore-like structure for promoting the ingrowth of connective tissue orMigration of macrophages and fibroblasts. For example, the pores or openings can be approximately 100 micrometers or smaller, preferably between 10 and 40 micrometers. The structured surface 60 can, on the one hand, prevent or at least reduce the risk of multiple macrophages joining to form giant cells. On the other hand, the settlement of fibroblasts to promote collagen production can be enabled or promoted. In embodiments, the structured surface 60 can comprise a foamed layer. In particular, the structured surface 60 can comprise a film made of a foam material. In embodiments, the film made of foam material can be connected to the first layer and / or the second layer of the shell 10 by a thermal process. The structured surface 60 can be positively and / or materially connected to the first layer 14 and / or the second layer 16 of the shell 10.In embodiments, the film of foam material can be applied, in particular thermoformed, to the first 14 and / or the second layer 16 of the shell 10. As can be clearly seen in Figs. 4b and 5b, the structured surface 60 can, in some embodiments, be arranged on an inner side 11 and an outer side 12 of the shell 10. In other words, the implant 100 can comprise a structured inner layer 61 that is arranged on the inner side 11 of the shell 10. In this case, the structured inner layer 61 can define the inner surface of the implant 100. The implant 100 can further comprise a structured outer layer 62 that is arranged on the inner side 12 of the shell 10. In this case, the structured outer layer 62 can define the outer surface of the implant 100. The at least partially two-layer layer structure of the shell 10 (orthe optional at least partially single-layer layer structure of the shell 10) is to be understood without the optional structured surface 60, 61, 62 of the implant 100 if this structured surface 60, 61, 62 is formed by a further layer, in addition to the first layer 14 and the second layer 16.

[0149] As shown in Figs. 4b and 5b, the structured surface 60 can also be arranged on the expandable units 20 and the connecting pieces 24. Furthermore, the structured surface 60, 64 can be arranged at least partially on the electrode web 30. In other words, the structured surface 60 can comprise a structured electrode web layer 64 arranged on an outer side of the electrode web 30. In embodiments, the structured surface 60, 66 can at least partially enclose the ring 46. In other words, the structured surface 60 can comprise a structured ring layer 66 that at least partially encloses the ring 46. In particular, a separate film made of a foam material can be molded onto the upper edge 40 surrounding the ring 46. For example, the third layer 66 described above with reference to Figs. 6a and 6b can be formed as a structured ring layer 66.In embodiments, the structured ring layer 66 may include one or more features of the U-shaped overlap layer described above. A structured ring layer may further serve to minimize the potential for injury from the ring.

[0150] As already mentioned above, the heart assist device 1 comprises a supply system 200 connected to the implant 100. The supply system 200 is designed and arranged to extend laterally away from the implant 100 in the proximal direction 2b. Laterally can be understood, for example, as extending in a region between the lower opening 48 and the upper edge 40.

[0151] As already mentioned, the supply line system 200 can, for example, comprise three fluidic supply lines 220a, 220b, 220c, wherein the first fluidic supply line 220a can be connected to the first expandable unit 20a, the second fluidic supply line 220b to the second expandable unit 20b, and the third fluidic supply line 220c to the third expandable unit 20c. Furthermore, the supply line system 200 can comprise at least one electrical supply line 37, 38, particularly if the implant 100 comprises at least one electrode 31, 32. In the example explained above, the implant 100 has six electrodes 31, 32, wherein a first electrode 31 and a second electrode 32 are arranged in each of the three electrode webs 30. The first electrodes 31 are each connected to a first electrical supply line 37. The second electrodes 32 each have a second electrical lead 38 (see Figs. 8a and 8b). In some embodiments, as in Figs.As shown in Figs. 3a, 3b, the first and second electrical supply lines 37, 39 can each be guided in a common (electrical) supply line section 39 in the distal direction 2b to the electrode web 30. In the region of the electrode web 30, in particular within the electrode web 30, the common supply line section 39 can be separated. This means that the two electrical supply lines 37, 38 are spatially separated from one another and guided to the respective electrode 31, 32. For this reason, a first common supply line section 39a leading to the first electrode web 30a is shown by way of example in Figs. 3a, 3b. A second common supply line section 39b leads to the second electrode web 30b.Although in this example, the supply line system 200 may comprise six electrical supply lines 37, 38, it is conceivable that the supply line system 200 may comprise more or fewer than six electrical supply lines 37, 38, for example, nine electrical supply lines. The electrical supply lines 37, 38 and the fluidic supply lines 220 may be generally referred to as supply lines.

[0152] The supply system 200 is designed and arranged such that it is guided in the proximal direction 2b from posterior over the left ventricle to the anterior, from there to the right along the shell 10, and then medially away from the implant 100 (see in particular Figs. 3b, 5a, 5b, 9a, and 9b). In other words, the supply system 200 is guided counterclockwise in the proximal direction 2b along the outer surface 12 of the shell 10, as viewed from below toward the lower opening 48 on the implant 100. At the third expandable unit 20c or the third fluidic supply line 220c, which ends at the most proximal position compared to the other fluidic supply lines 220a, 220b, the supply system 200 is guided medially away from the implant 100 in the proximal direction 2b. This means that the supply system 200 passes through the pericardium to the right.Alternatively, the supply system 200 is guided from an anterior position in the proximal direction 2b medially over the upper edge of the implant. In some embodiments, the supply system 200 can be guided away from the implant 100, projecting beyond the upper edge 40 (see Fig. 9a). This is to be understood in such a way that a plane spanned by the upper edge 40 or a plane spanned by the valve plane of the heart (basal plane) is crossed by the supply system 200 in the proximal direction 2b. As a result, the supply system can initially be guided medially within the body above the diaphragm. The supply line can penetrate the diaphragm close to the meridian plane. This can reduce the transmission of the diaphragmatic movement via the supply line to the shell 10 or the implant 100. If the supply line 200 were to be close, e.g.If the lead 200 were to be passed through the diaphragm before reaching the median plane, the distance of the lead 200 between the diaphragmatic passage and the shell 10 would be shorter than before, and movements of the diaphragm would be transmitted more strongly to the shell 10 or the implant 100 over the shorter distance of the lead. This would increase the risk of displacement of the implant due to diaphragmatic movements. Furthermore, by routing the lead 200 over the upper edge 40, the advantage of optimized lead routing with regard to the cardiac vessels can be achieved. In addition, by routing all leads together (in the proximal direction) in the same direction of orientation (e.g., anteriorly and then to the right; or counterclockwise), the risk of kinking of the leads can be prevented or at least reduced. In addition, such a lead arrangement can achieve more stable lead placement.In addition, by routing the supply line from posterior via left to anterior and further to the right, the direction of the supply line can already be provided parallel to a coronary plane, which in turn simplifies the discharge from or supply to the implant 100 from the right side. If, on the other hand, the supply line were to be discharged in the posterior direction 2b not over the upper edge 40 of the implant 100, but in the longitudinal direction of the heart over the apex of the heart, the supply line would pass through the diaphragm at a very short distance, strike the ribs or the rib cage, or would have to be led out of the rib cage between the ribs. In each of these examples, movements of the diaphragm and / or the rib cage over the very short supply line distance would have a very strong effect on the shell 10 of the implant 100 and entail the risk of displacement of the implant 100 in the implanted state.Furthermore, if the supply line 200 were to be routed out of the patient's chest on the left side, there would still be only a very short supply line distance between the skin exit of the supply line 200 and the implant 100, meaning that possible infections at the skin exit point always entail a high risk of implant infections. In contrast, if it is routed via the upper edge 40 of the implant, the supply line 200 is routed over a long distance medially within the body, through the diaphragm, under the right costal arch, and then extracorporeally with a skin exit point in the right lateral abdominal region (also shown in Figs. 9A and 9B). This reduces the probability that an infection at the skin exit point will lead to an infection of the implant 100. The length of the intracorporeal supply line section 200a can be between 25 cm and 80 cm, ideally between 30 cm and 60 cm.

[0153] The terms anterior and posterior refer to regions or directions relative to a patient (or their heart or the implant in the implanted state). Anterior refers to a front side of the patient, and posterior refers to a back side or back regions of the patient. With respect to the heart or the implant 100, anterior thus refers to regions and directions in front of the heart toward the front of the patient. With respect to the heart or the implant 100, posterior thus refers to regions and directions behind the heart toward the back (see also Fig. 9b). To simplify spatial orientation and / or positioning of the implant 100 for the surgeon, a posterior marker 3, for example a marker elevation, can be provided on the implant 100, which indicates a posterior side of the implant 100 in the intended implanted state (see Fig. 3b).In embodiments, the marking 3 can be colored and / or radiopaque. Thus, the marking 3 can be visible even in the non-implanted state. In embodiments, the marking 3 can be designed as a P-shape. The "P" shape is asymmetrical so that the correct alignment after implantation can be assessed by X-ray or CT. For example, the implant 100 can be correctly positioned if the "P" can be seen under X-ray imaging approximately in the middle of the patient's vena cava, which can be differentiated from other anatomical structures with the help of a contrast agent. Analogously, the terms "right" and "left" refer to the patient's body (see Fig. 9b). With regard to the heart or the implant 100, right therefore refers to areas and directions to the right of the heart towards the right side of the patient's body. With regard to the heart orof the implant 100, left therefore refers to areas and directions to the left of the heart towards the left side of the patient's body.

[0154] The first fluidic supply line 220a can thus be routed anteriorly via the left ventricle and then further to the right in the proximal direction 2b along the shell 10 (see Figs. 3b, 5a, 5b, and 9b). The second fluidic supply line 220b can thus be routed to the right in the proximal direction 2b along the shell 10 (see Figs. 3b, 5a, 5b, and 9a). The third fluidic supply line 220c can thus be routed to the right in the proximal direction 2b away from the shell 10 (see Figs. 3b, 5a, and 9a).

[0155] In some embodiments, one or more fixation points 222, 224 can be provided on the implant 100 for attaching one or more fluidic supply lines 220 thereto and for guiding them along the shell via the one or more fixation points 222, 224. The attachment of the one or more fluidic supply lines 220 serves to enable the fluidic supply lines to be guided in a directed manner. Furthermore, the attachment minimizes unwanted movement of the one or more fluidic supply lines 220 relative to the shell 10 or the surrounding body. If the fluidic supply lines 220 were not attached to the fixation points 222, 224, the unattached sections of the fluidic supply lines could experience undefined contact and relative movement to the outer surface 12 of the shell 10 or the surrounding body, causing friction between the contact partners.Friction between a fluidic supply line 220 and the shell 10 can lead to damage to the shell 10 or the fluidic supply line 220, which can result in loss of function of the implant 100. Friction between the fluidic supply line 220 and the body can damage the fluidic supply line or injure body tissue. Furthermore, undesired movement of the fluidic supply line 220 can cause deformation of the shell 10. For example, movement of a fluidic supply line 220 toward the shell 10 can exert a compressive force on the shell 10, and movement away from the shell 10 can exert a tensile force on the shell 10. Both compressive and tensile forces can lead to deformation of the shell 10, which in turn can cause loss of fit and thus loss of function or risk of damage to the implant 100 and injury to the surrounding tissue.Attaching the at least one fluidic supply line 220 to fixation points 222, 224 can result in contact between the fluidic supply line 220 and the shell 10 being established in a targeted manner at mechanically resilient positions, thus minimizing relative movements between the fluidic supply line 220 and the shell 10, and also between the fluidic supply line 220 and the surrounding body tissue. Undesired contact and undesired compressive and tensile forces between the fluidic supply line 220 and the shell 10 are thereby avoided. An exemplary embodiment with fixation points 222, 224 is shown in Fig. 5a. The first fluidic supply line 220a can be attached to the implant 100 via a first fixation point 222 in order to guide the first fluidic supply line 220a along the shell 10 via the first fixation point 222.As already mentioned above, the first fluidic supply line 220a can be the one arranged at the most distal point of the supply line system 200 or connected to the associated expandable unit 20a at the most distal point of the supply line system 200. The first fixation point 222 allows for targeted guidance of the first fluidic supply line 220a along the shell 10 and, in particular, past or around the expandable units 20.

[0156] The first fixation point 222 can, in particular, be arranged at a distance from the expandable units 20. For example, the first fixation point 222 can be arranged on one of the electrode webs 30. Preferably, the first fixation point 222 can be arranged on the electrode web 30b, which, viewed from below on the implant 100, is arranged counterclockwise adjacent to the first expandable unit 20a. In particular, the first fixation point 222 can be arranged on that end region 34, 36 of the electrode web 30c that is arranged closer to the lower opening 48 of the shell 10. This results in the advantage that the first fluidic supply line 220a is routed in a lower region of the implant 100. Compared to a fluidic supply line that runs along or over the expandable unit, the fluidic supply line 220 can have less influence on the expandable unit 20.Alternatively, the first fixing point 222 can be arranged, for example, adjacent to one of the electrode webs, in particular adjacent to an end region 34, 36 of one of the electrode webs 30, preferably adjacent to the end region 36 which is arranged closer to the lower opening 48 of the shell 10.

[0157] Further referring to Fig. 5a, the first and second fluidic supply lines 220a, 220b can be attached to the implant 100 via a second fixation point 224 in order to guide the at least two fluidic supply lines 220a, 220b along the shell 10 via the second fixation point 224. The second fixation point 224 can be arranged at a distance from the expandable units 20. For example, the second fixation point 224 can be arranged on one of the electrode webs 30. Preferably, the second fixation point 224 can be arranged on the electrode web 30c, which is arranged clockwise adjacent to the second expandable unit 20b when viewed from below from the lower opening 48 on the implant 100. In particular, the second fixing point 222 can be arranged at that of the end regions 34, 36 of the electrode web 30c which is arranged closer to the lower opening 48 of the shell 10.This provides the advantage that the first and second fluidic supply lines 220a, 220b are routed in a lower region of the implant 100. Compared to a fluidic supply line that runs along or over the expandable unit, the fluidic supply line 220 can have less influence on the expandable unit 20. Alternatively, the second fixation point 224 can be arranged, for example, adjacent to one of the electrode webs, in particular adjacent to an end region 34, 36 of one of the electrode webs 30, preferably adjacent to the end region 36 that is arranged closer to the lower opening 48 of the shell 10.

[0158] In particular, the second fixation point 224 can be arranged in the proximal direction 2b of the supply line to the fixation point 222. More precisely, the second fixation point 224 can be arranged at a position on the fluidic supply line 220, in particular the first fluidic supply line 220a, that is proximal to a position on the fluidic supply line 220, in particular the first fluidic supply line 220a, at which the first fixation point 222 is arranged.

[0159] In embodiments, one or both of the fixing points 222, 224 can be designed to guide the fluidic supply line 220 at a distance from the outer surface 12 of the shell 10. By spacing the fluidic supply line 220 from the outer surface 12 of the shell 10, contact between the fluidic supply line 220 and the outer surface 12 of the shell 10 can be reduced during movement of the shell 10 or parts thereof. In particular, contact or chafing can be avoided or at least reduced. This can reduce the risk of damage to the shell 10 and / or the expandable units 20. In embodiments, the spacing in the normal direction to the outer surface 12 of the shell 10 can be 0.5 mm to 2.5 mm. In particular, the spacing in the normal direction to the outer surface 12 of the shell 10 can be 1 mm to 2 mm. Preferably, the spacing in the normal direction to the outer surface 12 of the shell 10 may be at least 1.5 mm.Particularly preferably, the spacing in the normal direction to the outer surface 12 of the shell 10 can be 1.5 mm or 1.5 mm + / - 0.25 mm. The spacing can be understood as the distance between the outer surface 12 and the fluidic supply line 220 in the region of the fixing point 222, 224.

[0160] With reference to Figs. 2 and 3a, the supply line system 200 can further comprise a first splitting section 232. At the first splitting section 232, at least one fluidic supply line 220 can be branched off from the other supply lines 37, 38, 220 of the supply line system 200 in the distal direction 2a. Up to the first splitting section 232, the supply lines, in particular the fluidic supply lines 220, can be routed together. For example, the supply lines can be fastened to one another. In embodiments, the supply line system 200 can comprise a second splitting section 234. At the second splitting section 234, at least one fluidic supply line 220 can be branched off from the other supply lines 37, 38, 220 of the supply line system 200 in the distal direction 2a. In embodiments, the second splitting section 234 may be arranged distal to the first splitting section 232.

[0161] In detail, the first splitting section 232 can be arranged proximally in front of the expandable unit 20c that is arranged most proximally with respect to the supply line system 200. Thus, the first splitting section 232 can be arranged proximally in front of the implant 100. In the exemplary embodiment of Figs. 2 and 3a, the third fluidic supply line 220c is branched off from the other two fluidic supply lines 220a, 220b. The second splitting section 234, which is arranged more distally than the first splitting section 232, can be arranged proximally in front of the expandable unit 20b that is arranged distally adjacent to the most proximally arranged expandable unit 20c. This means that the second splitting section 234 is arranged proximally in front of the second expandable unit 220b. The second splitting section 234 can be arranged on the implant 100. In particular, the second splitting section 234 can be attached to the implant 100.In some embodiments, the second splitting section 234 can be arranged at one of the first or second fixation points 222, 224, preferably at the second fixation point 224. At the second splitting section 234, the second fluidic supply line 220b branches off from the first fluidic supply line 220a. Distal to the second splitting section 234, the second fluidic supply line 220b is routed to the second expandable unit 20b. Furthermore, the first fluidic supply line 220a is routed distal to the second splitting section 234 to the first expandable unit 20a.

[0162] In embodiments such as those shown in Figs. 1, 2, 4b, 5b, the delivery system 200 may comprise at least one anchoring sheath 212, 214. The anchoring sheath 212, 214 may be designed to promote the infiltration of cells, for example, macrophages or fibroblasts, and the ingrowth of tissue.

[0163] The at least one anchoring sheath 212, 214 can, for example, be a foamed, porous, nonwoven, fibrous, or woven structure. Regardless of whether the structure is foamed, porous, nonwoven, fibrous, or woven, the structure has recurring openings or defects in the material, which appear as pores, loops, holes, or gaps. The openings of the structure can measure approximately 100 micrometers or smaller in their average size, preferably between 10 and 40 micrometers. The average size of the openings can be selected such that the immigration of specific cell types, e.g., fibroblasts, is promoted. The average size of the openings can be selected such that the formation of giant cells by macrophages is prevented. The type of structure can be selected such that strong ingrowth and intergrowth of tissue, in particular connective tissue, with the anchoring sheath 212, 214 is promoted.For example, a strong fusion of connective tissue with the anchoring sheath 212, 214 can be achieved by selecting nonwoven, fibrous, or woven structures as the anchoring sheath. Nonwoven and woven structures represent embodiments of a fibrous structure. With nonwoven, fibrous, or woven structures, the connective tissue can easily grow around the fibers of the material of the anchoring sheath 212, 214, creating mechanically very stable connections that cannot be separated from one another without destruction. Such an anchoring sheath 212, 214 can be used, for example, to absorb forces acting externally on the supply line 200 or the anchoring sheath 212, 214 and transfer them to the ingrown connective tissue without damaging distant areas of the implant or causing displacement due to the external force.For example, a connection between connective tissue and a fleece-like, fibrous, or woven anchoring sheath 212, 214 cannot be severed without cutting or tearing. The connection between connective tissue and a fleece-like, fibrous, or woven anchoring sheath 212, 214 can be severed, for example, by shearing with a scalpel by a doctor, e.g., a surgeon. However, the anchoring sheath 212, 214 can also be selected such that only weak ingrowth or fusion of connective tissue with an anchoring sheath 212, 214 can occur. Weak ingrowth of connective tissue can be achieved, for example, by producing the anchoring sheath 212, 214 from a porous or foamed structure. This can be explained by the fact that the connective tissue is less able to wrap around the openings in a porous or foamed structure.Connections based only on a weak adhesion between connective tissue and an anchoring sheath 212, 214 can provide fixation of surrounding tissue to the anchoring sheath 212, 214 to prevent relative movement between a lead 200 or an implant 100 and the body environment, but only offer a mechanically weak connection. For example, a connection between connective tissue and a porous or foamed anchoring sheath 212, 214 can be severed atraumatically without cutting using a finger or non-sharp instruments (e.g., rounded surgical forceps).For example, a porous or foamed anchoring sheath 212, 214 can be used to position a lead or the implant in the correct location in the body and hold it there for the duration of implantation and yet allow for later explantation without cutting the anchoring sheath.

[0164] In particular, the lead system 200 may include at least one cardiac anchoring sheath 212 and at least one proximal anchoring sheath 214. In embodiments, the cardiac anchoring sheath 212 may be configured as a porous or foamed structure, and the proximal anchoring sheath 214 may be configured as a nonwoven, fibrous, or woven structure.This can be particularly advantageous because, when removing the implant 100 and the cardiac anchoring sheath 212, no cutting is required in the region near the heart, thus eliminating the risk of injury or damage to tissue near the heart or the heart muscle itself. On the other hand, the proximal anchoring sheath 214, which is located closer to the skin exit site in the implanted state, can safely transmit the forces acting on the lead 200 from outside to the patient's body without causing damage or displacement to distal regions of the lead and the implant 100. The structured surface 60 of the implant 100 can have the same structure as the cardiac anchoring sheath. This can enable explantation of the shell 10 of the implant 100 without cutting.

[0165] An anchoring sheath 212 can be arranged in the proximal direction 2b directly behind and / or on the first splitting section 232. This anchoring sheath can be configured in particular as a cardiac anchoring sheath 212. Alternatively or additionally, an anchoring sheath 212 can be arranged in the proximal direction 2b directly behind and / or on the second splitting section 234. This anchoring sheath can in particular also be configured as a cardiac anchoring sheath 212. This can ensure that the individual supply lines are only separated shortly before their destination. This ensures that the supply lines are fed together over a large part of the supply line section, which can result in less stress for the patient. In embodiments, the electrical supply lines 37, 38, 39 can be arranged, in particular fastened, to the fluidic supply lines 220.For example, the electrical supply lines 37, 38, 39 can be arranged between the fluidic supply lines 220. This provides additional protection for the electrical supply lines 37, 38, 39. The at least one proximal anchoring sheath 214 can, in particular, be arranged further proximal from the most proximal of the cardiac anchoring sheaths 212. In particular, a proximal anchoring sheath 214 can be arranged shortly behind the skin exit region in the distal direction 2a. This can, for example, prevent a risk of injury due to excessive movement of the supply line system. Alternatively or additionally, a proximal anchoring sheath 214 can be arranged in a central region of the intracorporeal supply line section 200a between the skin exit region and the first splitting section 232. This allows the course of the supply line system 200 through the patient's body to be better fixed.

[0166] In embodiments, excess cable length of the electrical supply line 37, 38, 39 can be stowed in one of the anchoring sheaths 212, 214. In particular, excess cable length of the electrical supply lines 37, 38, 39 can be stowed in the anchoring sheath 212, which is arranged directly behind the first splitting section 232 in the proximal direction 2b.

[0167] Within the scope of the present disclosure, an implantation method of the implant 100 is described with reference to Figs. 11 to 19. Figs. 11 to 19 show various steps of the implantation method and various states of the implant 100 during the various steps of the implantation method. This serves in particular to improve the comprehensibility and context of the present invention.

[0168] Figs. 11 to 14 show in detail the preparation of the implant for the implantation procedure. The implant can be carefully unpacked on a sterile table that is large enough to store the implant safely. The functionality of the ventricular assist device does not need to be tested prior to implantation. Contact with sharp instruments should be avoided. Care should be taken to ensure that a proximal cap of the lead system is always on the proximal end (plug) of the lead system when the plug is not plugged into the power unit. Therefore, the cap can be put on during preparation of the sterile implant and replaced immediately after disconnection from the power unit. The implant or shell can be soaked in warm sterile saline solution before the procedure to protect the material, particularly the textured surface, if present (e.g.foam) and to preheat the implant material to make it more flexible or to achieve liquid wetting of the active sides of the electrodes to enable better measurement of the ECG signal. One or two drops of a hydrogel can be used with a blunt cannula to moisten the active sides of the electrodes on the inside of the implant. This facilitates the detection of ECG signals during implantation. Furthermore, an implantation aid (e.g. foil bag) can be inserted through the apical opening (bottom opening) of the implant. The upper edge of the implantation aid can then be folded over the upper edge of the implant so that the entire cardiac part of the implant is covered by the implantation aid. Additional hydrogel can be used to moisten the implantation aid on both sides.

[0169] Figures 16 to 19 show a partial view of the surgical implantation of the implant. The implanting surgeon / physician performs a median (partial) sternotomy. The pericardium is opened medially from cranial to caudal so that the implant can be inserted. If necessary, pericardial sutures are used. The implant can be presented to the surgeon with the front (anterior side) facing upwards. In general, no sharp instruments should be used to handle the implant, as this could damage the electrodes or the inflatable cushions (expandable units). No sutures are required or provided to fix the implant to the heart, as its surface structure supports stable positioning of the implant within the pericardium and around the heart chambers. The shell can be gently compressed and folded during implantation to facilitate intrapericardial insertion.After expansion around the ventricles, correct automatic positioning should occur. Correct positioning can be verified by direct inspection and, if necessary, by manual palpation of the posterior part. X-ray imaging, e.g., using a C-arm, may also be advantageous for assessing final positioning. The lead system can be temporarily secured to the sterile surgical drapes with a clamp. In addition, hemodynamic parameters should be observed after insertion and expansion of the implant to ensure that they are not significantly impaired compared to the pre-implantation values. For position corrections or for removal of the implant and repeated implantation to achieve the desired position of the implant, the implant is equipped with at least one retraction aid. The retraction aids are shown as an example in Fig. 11.The retraction aids can be thread-like loops that are attached to the upper edge of the implant and extend over the outer surface of the shell towards the apex of the heart and beyond. The length of the loops can be between 10 cm and 30 cm when stretched, in particular between 12 cm and 25 cm, and in particular between 15 cm and 20 cm. If more than one retraction aid is present, the multiple retraction aids can be distributed along the upper edge of the implant. The retraction aids can be designed so that the physician can pull the implant away from the heart by pulling on the retraction aids, thus converting it from an implanted to a non-implanted state. The retraction aids are attached at mechanically resilient positions on the upper edge or on the implant to prevent damage to the implant when removing it from the implanted state.Without the retraction aids, the physician would have to pull on the supply line or at undefined points on the implant in order to reposition or temporarily remove the implant during the implantation procedure, which could lead to damage to the implant. Furthermore, if retraction aids are not available, the physician could use undefined, or in the worst case even pointed, tools to remove the implant, which also carries a high risk of damage. At least one retraction aid can be designed in such a way that it can be completely removed from the implant in one piece by pulling on the thread-like structure after the loop has been cut open. After positioning, the implantation aid is carefully removed from the apical direction through the lower opening of the implant while the implant is held in position.For this purpose, the implantation aid can be cut open lengthwise or separated lengthwise by hand along pre-perforated lines to make it easier to remove. It must be ensured that the entire implantation aid is removed. On the surface of the implant, centrally below the vena cava cutout, there is a posterior marker (e.g., a "P"-shaped marker), which can be used for the initial alignment of the implant and the heart. The marker can be colored and / or radiopaque. This allows the marker to be visible even in the non-implanted state. The "P" shape is asymmetrical, so that correct alignment after implantation can be assessed using X-ray or CT.When the implant is correctly positioned, the "P" should be visible under x-ray imaging approximately in the center of the patient's vena cava, which can be distinguished from other anatomical structures with the help of a contrast agent.

[0170] With reference to Fig. 15, it can be seen that markings "A", "L" and "R" can be arranged near the apex (at the lower opening). The markings "A", "L" and "R" can indicate the respective orientation of the expandable units along the circumference, i.e. anterior (A) (e.g. left anterior expandable unit), left ventricle (L) (e.g. left posterior expandable unit) and right ventricle (R) (e.g. right expandable unit). These markings can assist in the orientation of the implant with regard to its rotational position relative to the heart. In particular, the markings may not be radiopaque. However, the markings may also be partially visible in the implanted state as long as the site is open.

[0171] Correct positioning of the implant can be verified using the markings on the implant and anatomical landmarks. In some designs, correct positioning at the posterior wall can be verified using two fingers. For example, the implanted shell can be slightly lifted with two fingers to confirm correct positioning at the posterior wall. Care must be taken to ensure that the implant is not folded or crumpled in any way. After correct placement of the implant, the patient's cardiac parameters must be confirmed as stable. Once the implant is correctly positioned, care must be taken to completely remove the retraction aid if it was not already removed prior to implantation. The pericardium and the site are then closed.

[0172] The implant may require a certain amount of space within the opened pericardium, possibly large enough to be larger. For this reason, and to avoid external constriction, the implantation procedure can advantageously be performed gently and under hemodynamic monitoring. A closure of the pericardium that is too tight can lead to hemodynamic impairment and / or cardiac arrhythmias and must therefore be avoided. A closure that is too loose, leaving too much space, can create gaps between the epicardium and the implant, which can lead to intermittent ECG signal loss in the initial period after implantation and must therefore be avoided (and to unintended tissue formation in the second period after implantation).

[0173] In general, it can be advantageous to perform pericardial closure in stages. For example, from the apex to the base of the heart or starting on the aortic side. Pericardial closure supports stable positioning and optimizes contact of the electrodes with the epicardial surface, thus improving signal detection.

[0174] Although the present invention has been described above and defined in the appended claims, it should be understood that the invention may alternatively be defined according to the following embodiments:

[0175] 1. A heart assist device (1) comprising an implant (100) which comprises a shell (10), at least one expandable unit (20) and at least one electrode (31, 32), wherein the shell (10) has, at least in sections, a two-layer structure comprising a first layer (14) and a second layer (16).

[0176] 2. Heart assist device (1) according to embodiment 1, wherein the shell (10) is designed to at least partially enclose a heart.

[0177] 3. Heart assist device (1) according to any one of the preceding embodiments, wherein the shell (10) has at its upper edge (40) a first recess (43) and a second recess (44) which are shaped such that the shell (10) does not touch the coronary sinus and the vena cava in the implanted state.

[0178] 4. A heart assist device (1) according to any one of the preceding embodiments, wherein the first layer (14) and / or the second layer (16) is / are at least partially formed from a plastic, in particular polyurethane, silicone, polytetrafluoroethylene, polyethylene, PET, or polypropylene. 5. A heart assist device (1) according to any one of the preceding embodiments, wherein the first layer (14) and / or the second layer (16) comprises polyurethane, in particular a thermoplastic polyurethane (TPU).

[0179] 6. Heart assist device (1) according to any one of the preceding

[0180] Embodiments, wherein the shell (10) is produced by thermoforming.

[0181] 7. Heart assist device (1) according to any one of the preceding

[0182] Embodiments, wherein the first layer (14) and / or the second layer (16) is a film.

[0183] 8. Heart assist device (1) according to any one of the preceding

[0184] Embodiments, wherein the shell (10) has an opening (48) at its lower tip.

[0185] 9. Heart assist device (1) according to any one of the preceding

[0186] Embodiments, further comprising a ring (46) attached to an upper

[0187] edge (40) of the shell (10).

[0188] 10. Heart assist device (1) according to embodiment 9, wherein the ring (46) is molded onto the upper edge (40) of the shell (10).

[0189] 10a. Cardiac assist device (1) according to any one of embodiments 9-10, wherein a shape of the ring is shaped such that the ring does not touch the vena cava and / or coronary sinus in the implanted state.

[0190] 11. Cardiac assist device (1) according to any one of embodiments 9 - 10, wherein the ring (46) extends at least partially along the upper edge (40) of the shell (10).

[0191] 12. The cardiac assist device (1) according to any one of embodiments 9-11, wherein the ring (46) is configured to return to its previous state after mechanical deformation. 13. The cardiac assist device (1) according to any one of embodiments 9-12, wherein the ring (46) is arranged between the first layer (14) and the second layer (16).

[0192] 14. Heart assist device (1) according to any one of embodiments 9 - 13, wherein the ring (46) is attached, in particular welded, to the shell (10).

[0193] 15. Heart assist device (1) according to any one of embodiments 9 - 14, wherein the ring (46) has a round, in particular circular, cross-section.

[0194] 16. Heart assist device (1) according to any one of embodiments 9 - 15, wherein the ring (46) is at least partially formed from a plastic, in particular polyurethane, silicone, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polyamide and / or polypropylene.

[0195] 17. Heart assist device (1) according to any one of embodiments 9 - 16, wherein the ring (46) has a greater hardness than the shell (10).

[0196] 18. Heart assist device (1) according to any one of embodiments 9 - 17, wherein the ring (46) comprises a material having a Shore hardness D of at least 50, preferably at least 60 and particularly preferably at least 65.

[0197] 19. Heart assist device (1) according to any one of embodiments 9-18, wherein the shell (10) comprises a material with a Shore D hardness of maximum 45, preferably maximum 40 and particularly preferably maximum 35. 0. Heart assist device (1) according to any one of the preceding embodiments, wherein the at least one expandable unit (20) comprises a chamber (22) formed between the first layer (14) and the second layer (16). 21. Heart assist device (1) according to embodiment 20, wherein the first layer (14) and the second layer (16) are sealingly connected to one another along a closed line (15) to form the chamber (22).

[0198] 22. Heart assist device (1) according to any one of the preceding embodiments, wherein the at least one expandable unit (20) comprises a connection piece (24) arranged on the shell (10) for connection to a fluidic supply line (220) of a supply system (200) of the heart assist device (1).

[0199] 23. Heart assist device (1) according to embodiment 22, wherein the connecting piece (24) comprises an outlet inclined relative to an outer surface (12) of the shell (10) in order to guide the fluidic supply line (220) laterally along the shell (10).

[0200] 24. Heart assist device (1) according to any one of embodiments 22 - 23, wherein the connecting piece (24) is designed to receive the fluidic supply line (220) parallel to an outer surface of the shell (10) or inclined away from the outer surface.

[0201] 25. Heart assist device (1) according to any one of embodiments 22 - 24, wherein the connecting piece (24) is designed to receive the fluidic supply line (220) at an angle between 0° and 30°, preferably between 0° and 15°, relative to an outer surface of the shell (10).

[0202] 26. Heart assist device (1) according to any one of embodiments 22-25, wherein the connecting piece (24) is designed to receive the fluidic supply line (220) spaced apart by a distance from an outer surface of the expandable unit (20).

[0203] 27. A heart assist device (1) according to embodiment 26, wherein the spacing in the normal direction to the outer surface is 0.5 mm to 2.5 mm, in particular 1 mm to 2 mm, and preferably 1.5 mm + / - 0.25 mm. . A heart assist device (1) according to any one of embodiments 22 to 27, when at least dependent on embodiment 21, wherein the connecting piece (24) is fluidically connected to the chamber (22) at a distance from the closed line (15). . A heart assist device (1) according to any one of the preceding embodiments, wherein the at least one expandable unit (20) can be expanded by filling it with a fluid. . A heart assist device (1) according to any one of the preceding embodiments, wherein the at least one expandable unit (20) is adjustable between a non-expanded configuration and an expanded configuration. .A heart assist device (1) according to embodiment 30, wherein the at least one expandable unit (20) expands towards an inner side (11) of the shell (10) and towards an outer side (12) of the shell (10) when adjusted from the non-expanded configuration to the expanded configuration. a. A heart assist device (1) according to any one of embodiments 20 to 31, wherein the at least one expandable unit (20) comprises at least one circular corrugation (26) arranged in the layer (14, 16) on the inner side (11) of the shell (10). b. A heart assist device (1) according to embodiment 31a, when at least dependent on embodiment 30, wherein the at least one expandable unit (20) expands towards an inner side (11) of the shell (10) than towards an outer side (12) of the shell (10) when adjusted from the non-expanded configuration to the expanded configuration due to the corrugation (26). c.A heart assist device (1) according to any one of embodiments 31a or 31b, wherein the at least one circular corrugation (26) is configured to increase a volume of the chamber (22) compared to an expandable unit (20) without corrugation.

[0204] 3 Id. Cardiac assist device (1) according to any one of embodiments 31a to 31c, wherein the at least one corrugation (26) is embossed into the layer (14, 16).

[0205] 3 le. Cardiac assist device (1) according to any one of embodiments 31a to 31d, wherein the at least one corrugation (26) on an inner side (11) of the shell (10) is convex.

[0206] 3 If cardiac assist device (1) according to any one of embodiments 31a to 3 le, when at least dependent on embodiment 21, wherein the at least one corrugation (26) is arranged directly adjacent to or spaced from the closed line (15).

[0207] 31g. Cardiac assist device (1) according to embodiment 31f, wherein a distance (27) between the at least one corrugation (26) and the closed line (15) is between 1 mm and 20 mm, in particular between 2 mm and 10 mm.

[0208] 31h. Cardiac assist device (1) according to embodiment 31g, wherein the distance (27) between the at least one corrugation (26) and the closed line (15) is constant.

[0209] 3 li. Heart assist device (1) according to any one of embodiments 31a to 31h, when at least dependent on embodiment 30, wherein a width (26a) of the at least one corrugation (26) in the non-expanded state is 1 mm to 15 mm, in particular 2 mm to 10 mm.

[0210] 32. A cardiac assist device (1) according to any one of the preceding embodiments, wherein the implant (100) comprises a plurality, in particular three, spaced-apart expandable units (20). 33. A cardiac assist device (1) according to embodiment 32, wherein at least one electrode (31, 32), in particular two electrodes (31, 32), is arranged between each two adjacent expandable units (20).

[0211] 33a. A cardiac assist device (1) according to any one of embodiments 32 or 33, wherein the shell (10) comprises an expansion assembly (54) disposed between two adjacent expandable units (20).

[0212] 33b. Cardiac assist device (1) according to embodiment 33a, wherein the expansion arrangement (54) comprises one or more cutouts (55) and / or cuts (56) providing passages between the inner side (11) of the shell (10) and the outer side (12) of the shell (10).

[0213] 33c. Heart assist device (1) according to embodiment 33b, wherein the one or more cutouts (55) of the expansion arrangement (54) each have a surface area of ​​0.5% to 10%, in particular 1% to 8% and preferably 2% to 5% relative to a total surface area on the outer side (12) between the upper edge (40) and the lower opening (48).

[0214] 33d. Heart assist device (1) according to any one of embodiments 33b or 33c, wherein the expansion arrangement (54) comprises a plurality of cutouts (55) and / or cuts (56) between which webs are formed, which extend in particular in the circumferential direction.

[0215] 33e. Heart assist device (1) according to any one of embodiments 33b to 33d, wherein the one or more cutouts (55) and / or cuts (56) are at least partially covered by an expansion layer having a higher elasticity than the layer (14, 16) surrounding the one or more cutouts (55) and / or cuts (56).

[0216] 33f. Cardiac assist device (1) according to any one of embodiments 33b to 33e, wherein at least one of the one or more cutouts (55) and / or cuts (56) has a zigzag shape, which extends in particular in the circumferential direction. Cardiac assist device (1) according to any one of the preceding embodiments, wherein the implant (100) further comprises at least one electrode web (30) to which at least one of the at least one electrode (31, 32) is attached. Cardiac assist device (1) according to embodiment 34, wherein the electrode web (30) is arranged, in particular attached, on an outer side (12) of the shell (10). Cardiac assist device (1) according to any one of embodiments 34 or

[0217] 35, wherein the shell (10) has a passage (41, 42) to an inner side of the implant (100), wherein the passage (41, 42) is arranged and configured such that the at least one electrode (31, 32) extends with its active side (31a, 32a) through the passage (41, 42) to the inner side (11). a. Heart assist device (1) according to any one of embodiments 34 to

[0218] 36, wherein the active side (31a, 32a) of the electrode (31, 32) is arranged flush with the inner side (11) of the implant (100). . Cardiac assist device (1) according to any one of embodiments 34 to 36a, wherein the at least one electrode (31, 32) is embedded in the electrode web (30) such that the active side (31a, 32a) of the electrode (31, 32) protrudes from the electrode web (30). . Cardiac assist device (1) according to any one of embodiments 34 to

[0219] 37, wherein the at least one electrode (31, 32) is surrounded by a material, in particular overmolded, in order to form the electrode web (30). . Heart assist device (1) according to any one of the embodiments 34 to

[0220] 38, wherein the electrode web (30) comprises a plastic material, in particular polyurethane, epoxy, silicone, polytetrafluoroethylene, polyethylene, polyethylene terephthalate, polyamide and / or polypropylene.

[0221] 40. Cardiac assist device (1) according to any one of embodiments 34 to 39, wherein two electrodes (31, 32) are attached to the electrode web (30).

[0222] 41. Cardiac assist device (1) according to embodiment 40, wherein the two electrodes (31, 32) are arranged in opposite end regions (34, 36) of the electrode web (30).

[0223] 42. Heart assist device (1) according to embodiment 41, wherein the two end regions (34, 36) are connected to one another via a waist (35).

[0224] 43. Heart assist device (1) according to any one of embodiments 40 to

[0225] 42, wherein electrical supply lines (37, 38) to the two electrodes (31, 32) have a common supply line section (39) which is separated in the region of the electrode web (30), in particular within the electrode web (30).

[0226] 44. Heart assist device (1) according to any one of embodiments 34 to

[0227] 43, wherein the electrode web (30) comprises a strain relief for an electrical supply line (37, 38) to the at least one electrode (31, 32).

[0228] 45. Cardiac assist device (1) according to embodiment 44, wherein the strain relief is formed by an arcuate course of the electrical supply line (37, 38) within the electrode web (30).

[0229] 46. ​​The cardiac assist device (1) according to any one of embodiments 34 to 45, wherein the electrode web (30) is arranged on the shell (10) such that a longitudinal extension of the electrode web (30) is arranged substantially orthogonal to the upper edge (40) of the shell (10). 47. The cardiac assist device (1) according to any one of embodiments 34 to 46, wherein the implant (100) comprises three electrode webs (30) arranged at a distance, in particular circumferentially, from one another on the outer side of the shell (10).

[0230] 48. Heart assist device (1) according to embodiment 47, if at least dependent on embodiment 32, wherein the electrode webs (30) are each arranged between two adjacent expandable units (20).

[0231] 49. Heart assist device (1) according to any one of the preceding embodiments, wherein the shell (10) comprises at least in sections a conductive region having a perforation (50) and / or a plurality of conductive elements in order to establish a fluidic and / or conductive connection between the inner side (11) of the shell (10) and the outer side (12) of the shell (10).

[0232] 50. A cardiac assist device (1) according to embodiment 49, wherein the conductive region comprises a perforation (50) comprising a plurality of passages (52) between the inner side (11) and the outer side (12) of the shell (10).

[0233] 50a. Cardiac assist device (1) according to any one of embodiments 49 or 50, wherein the perforation (50) comprises between 5 and 150 passages (52), in particular wherein the perforation (50) comprises a maximum of 150 passages (52).

[0234] 50b. Cardiac assist device (1) according to any one of embodiments 49 or 50, wherein the perforation (50) comprises a maximum of 150, in particular a maximum of 120, preferably a maximum of 100, and particularly preferably a maximum of 80 passages (52).

[0235] 50c. Cardiac assist device (1) according to any one of embodiments 49 to 50b, wherein the perforation (50) comprises at least 5, in particular at least 10, preferably at least 15, and particularly preferably at least 30 passages (52).

[0236] 51. A heart assist device (1) according to any one of embodiments 49 to 50c, wherein the passages (52) of the perforation (50) are circular. 52. A heart assist device (1) according to any one of embodiments 49 to

[0237] 51, wherein the passages (52) of the perforation (50) have a diameter between 0.1 mm and 5 mm, preferably between 0.5 mm and 2.5 mm, and particularly preferably between 0.75 and 1.5 mm.

[0238] 53. Heart assist device (1) according to any one of embodiments 49 to

[0239] 52, if at least dependent on embodiment 25, wherein the perforations (50) are arranged in regions of the shell (10) adjacent to the at least one electrode web (30) and / or in regions of the shell (10) adjacent to the at least one expandable unit (20).

[0240] 53a. Heart assist device (1) according to any one of embodiments 49 to

[0241] 53, wherein the perforation (50) has an area proportion of 0.1% to 20%, in particular 0.5% to 10% and preferably 1% to 5% relative to a total area on the outer side (12) between the upper edge (40) and the lower opening (48).

[0242] 53b. Cardiac assist device (1) according to any one of embodiments 49 to 53a, wherein the perforation (50) is arranged unevenly distributed on the shell (10).

[0243] 53c. Cardiac assist device (1) according to any one of embodiments 49 to 53b, wherein the passages (52) of the perforation (50) are dimensionally stable.

[0244] 54. Cardiac assist device (1) according to any one of the preceding embodiments, wherein the implant (100) has a structured surface (60) which promotes the migration of cells, in particular macrophages and / or fibroblasts.

[0245] 55. The cardiac assist device (1) according to embodiment 54, wherein the structured surface (60) comprises a foamed layer, in particular a film made of a foam material. 56. The cardiac assist device (1) according to embodiment 55, wherein the film made of foam material is bonded to the first and / or second layer of the shell (10) by a thermal process.

[0246] 57. Heart assist device (1) according to any one of embodiments 55 or

[0247] 56, wherein the sheet of foam material is thermoformed onto the first and / or second layer of the shell (10).

[0248] 58. Heart assist device (1) according to any one of embodiments 54 to

[0249] 57, wherein the structured surface (60, 61, 62) is arranged on an inner side (11) and / or an outer side (12) of the shell (10).

[0250] 59. Heart assist device (1) according to any one of embodiments 54 to

[0251] 58, wherein the structured surface (60, 61, 62) is arranged at least partially on the at least one expandable unit (20).

[0252] 60. Heart assist device (1) according to any one of embodiments 54 to

[0253] 59, if at least dependent on embodiment 22, wherein the structured surface (60, 62) is at least partially arranged on the connecting piece (24).

[0254] 61. Heart assist device (1) according to any one of embodiments 54 to

[0255] 60, if at least dependent on embodiment 34, wherein the structured surface (60, 64) is at least partially arranged on the electrode web (30).

[0256] 62. Heart assist device (1) according to any one of embodiments 55 to

[0257] 61, if at least dependent on embodiment 9, wherein the structured surface (60, 66) at least partially envelops the ring (46).

[0258] 63. Heart assist device (1) according to any one of the preceding embodiments, further comprising a supply system (200) connected to the implant (100), wherein the supply system (200) is guided laterally away from the implant (100) in the proximal direction (2b). Heart assist device (1) according to embodiment 63, wherein the supply system (200), in particular in the implanted state, is guided anteriorly and / or to the right in the proximal direction (2b) along the shell (10) and then guided away from the implant (100). Heart assist device (1) according to embodiment 63 or 64, wherein the supply system (200), in particular in the implanted state, is guided away from the implant (100) projecting beyond the upper edge (40).Cardiac assist device (1) according to any one of embodiments 63 or 64, wherein the supply line system (200) comprises at least one fluidic supply line (220) and at least one electrical supply line (37, 38) for supplying the implant (100) from a supply unit (300). Cardiac assist device (1) according to embodiment 66, wherein the supply line system (200) comprises three fluidic supply lines (220). Cardiac assist device (1) according to any one of embodiments 66 or 67, wherein the supply line system (200) comprises at least six, preferably nine, electrical supply lines (37, 38). Cardiac assist device (1) according to embodiment 68, wherein each of the six electrical supply lines (37, 38) is connected to an electrode (31, 32) of the at least one electrode (31, 32).Heart assist device (1) according to embodiment 69, wherein at least two electrical supply lines (37, 38) are guided in a common supply line section (39) in the distal direction (2a) to the implant (100). Heart assist device (1) according to any one of embodiments 66 to 70, wherein the at least one fluidic supply line (220) is connected to the at least one expandable unit (20). Heart assist device (1) according to any one of embodiments 66 to 70.

[0259] 71, wherein the at least one fluidic supply line (220), in particular in the implanted state, is guided anteriorly and / or to the right in the proximal direction (2b) along the shell (10). Cardiac assist device (1) according to any one of embodiments 66 to

[0260] 72, wherein at least one of the three fluidic supply lines (220) is attached to the implant (100) via a first fixation point (222) in order to guide the at least one fluidic supply line (220) along the shell (10) via the first fixation point (222). Cardiac assist device (1) according to embodiment 73, wherein the first fixation point (222) is arranged at a distance from the at least one expandable unit (20). Cardiac assist device (1) according to any one of embodiments 73 or

[0261] 74, wherein the first fixation point (222) is arranged on or adjacent to an electrode web (30). Cardiac assist device (1) according to any one of embodiments 66 to

[0262] 75, wherein at least two of the three fluidic supply lines (220) are attached to the implant (100) via a second fixation point (224) in order to guide the at least two fluidic supply lines (220) along the shell (10) via the second fixation point (224). Cardiac assist device (1) according to embodiment 76, wherein the second fixation point (224) is arranged at a distance from the at least one expandable unit (20). Cardiac assist device (1) according to any one of embodiments 76 or 77, wherein the second fixation point (224) is arranged on or adjacent to an electrode web (30). 79. Cardiac assist device (1) according to any one of embodiments 76 to

[0263] 78, when at least dependent on embodiment 61, wherein the second fixation point (224) is arranged proximal to the first fixation point (222).

[0264] 80. Heart assist device (1) according to any one of embodiments 73 to

[0265] 79, wherein the fixing point (222, 224) is designed to receive the fluidic supply line (220) spaced apart from an outer surface of the shell (10).

[0266] 81. Heart assist device (1) according to embodiment 80, wherein the spacing in the normal direction to the outer surface is 0.5 mm to 2.5 mm, in particular 1 mm to 2 mm, and preferably 1.5 mm + / - 0.25 mm.

[0267] 82. Heart assist device (1) according to any one of embodiments 66 to

[0268] 81, wherein the supply line system (200) comprises a first splitting section (232) at which at least one fluidic supply line (220) is branched off from the other supply lines (37, 38, 220) of the supply line system (200) in the distal direction (2a).

[0269] 83. Heart assist device (1) according to any one of embodiments 66 to

[0270] 82, wherein the supply line system (200) comprises a second splitting section (234) at which at least one fluidic supply line (220) is branched off from the other supply lines (37, 38, 220) of the supply line system (200) in the distal direction (2a).

[0271] 84. A cardiac assist device (1) according to embodiment 83, when at least dependent on embodiment 82, wherein the second splitting section (234) is arranged distal to the first splitting section (232).

[0272] 85. A heart assist device (1) according to any one of embodiments 82 to 84, when at least dependent on any one of embodiments 73 to 79, wherein at least one of the first or second splitting sections (232, 234) is arranged at one of the first or second fixation points (222, 224). 86. A heart assist device (1) according to any one of embodiments 82 to

[0273] 85, wherein the first splitting section (232) is arranged proximally in front of the implant (100).

[0274] 87. Heart assist device (1) according to any one of embodiments 83 to

[0275] 86, wherein the second splitting section (234) is arranged on the implant (100).

[0276] 88. Heart assist device (1) according to any one of embodiments 63 to

[0277] 87, wherein the delivery system (200) comprises at least one anchoring sheath (212, 214) designed to promote cell migration and tissue ingrowth.

[0278] 89. A cardiac assist device (1) according to embodiment 88, wherein the lead system (200) comprises at least one cardiac anchoring sheath (212) and a proximal anchoring sheath (214).

[0279] 90. Cardiac assist device (1) according to embodiment 89, wherein the cardiac anchoring sheath (212) is designed to promote infiltration of macrophages and / or fibroblasts.

[0280] 91. Heart assist device (1) according to any one of embodiments 89 or

[0281] 90, wherein the proximal anchoring sheath (214) is designed to promote connective tissue ingrowth.

[0282] 92. Heart assist device (1) according to any one of embodiments 88 to

[0283] 91, if at least dependent on embodiment 82, wherein an anchoring sheath (212) is arranged in the proximal direction (2b) directly behind the first splitting section (232).

[0284] 93. Heart assist device (1) according to any one of embodiments 88 to

[0285] 92, if at least dependent on embodiment 83, wherein an anchoring sheath (212) is arranged in the proximal direction (2b) directly behind the second splitting section (234). Cardiac assist device (1) according to any one of embodiments 92 or

[0286] 93, wherein the anchoring sheath (212) is a cardiac anchoring sheath (212). Cardiac assist device (1) according to any one of embodiments 66 to

[0287] 94, if at least dependent on embodiment 92, wherein excess cable length of the at least one electrical supply line (37, 38) is stored in the anchoring sheath (212), which is arranged in the proximal direction (2b) directly behind the first splitting section (232). Cardiac assist device (1) according to any one of embodiments 63 to

[0288] 95, wherein the supply system (200) comprises an intracorporeal supply section (200a) for connection to the implant (100), and an extracorporeal supply section (200b) for connection to a supply unit (300). Heart assist device (1) according to any one of the preceding

[0289] Embodiments, further comprising a supply unit (300). Cardiac assist device (1) according to embodiment 97, when at least dependent on embodiment 63, wherein the supply unit (300) is connected to the implant (100) via the supply system (200).

[0290] List of reference symbols

[0291] Cardiac assist device 43 First notch a Distal direction 44 Second notch b Proximal direction 46 Ring

[0292] Posterior marker 48 Apex opening 0 Shell 50 Perforation 1 Inner side 52 Perforation passes 2 Outer side 54 Expansion arrangement 4 First layer 55 Cutout 5 Closed line 56 Cut 6 Second layer 60 Textured surface 0 Expandable unit 61 Textured inner layer 0.1 Expandable unit without corrugation 62 Textured outer layer 0.2 Expandable unit with corrugation 64 Structured electrode bridge layer2 Chamber 66 Structured ring layer 4 Connection piece 70a Time axis 6 Corrugation 70b Voltage axis 6a Width 72 Optimized ECG 7 Distance 74 Attenuated ECG 0a / b / c Electrode bridge 100 Implant 1, 32 Electrode 200 Lead system 1a, 32a Active electrode side 200a Intracorporeal lead section4 First end region 200b Extracorporeal lead section5 Waist 212 Cardiac anchoring sheath6 Second end region 214 Proximal anchoring sheath7, 38 Electrical leads 220a / b / c Fluidic leads 9a / b / c Common lead section 222, 224 Fixation point 0 Upper edge 232, 234 Splitting section 1, 42 passage 300 supply unit.

Claims

Patent claims 1. A heart assist device (1) comprising an implant (100) which comprises a shell (10), at least one expandable unit (20) and at least one electrode (31, 32), wherein the shell (10) has, at least in sections, a two-layer structure comprising a first layer (14) and a second layer (16).

2. Heart assist device (1) according to claim 1, wherein the shell (10) has a first recess (43) and a second recess (44) at its upper edge (40) which are shaped such that the shell (10) does not touch the coronary sinus and the vena cava in the implanted state.

3. Heart assist device (1) according to any one of the preceding claims, wherein the first layer (14) and / or the second layer (16) comprises polyurethane, in particular a thermoplastic polyurethane (TPU).

4. A heart assist device (1) according to any one of the preceding claims, wherein the shell (10) has an opening (48) at its lower tip.

5. A heart assist device (1) according to any one of the preceding claims, further comprising a ring (46) arranged on an upper edge (40) of the shell (10), wherein the ring (46) is integrally formed with the upper edge (40) of the shell (10), and wherein the ring (46) has a greater hardness than the shell (10).

6. A heart assist device (1) according to any one of the preceding claims, wherein the at least one expandable unit (20) comprises a chamber (22) formed between the first layer (14) and the second layer (16) and optionally, wherein the first layer (14) and the second layer (16) are sealingly connected to one another along a closed line (15) to form the chamber (22).

7. Heart assist device (1) according to claim 6, wherein the at least one expandable unit (20) comprises at least one circular corrugation (26) arranged in the layer (14, 16) arranged on an inner side (11) of the shell (10).

8. Heart assist device (1) according to any one of the preceding claims, wherein the implant (100) comprises several, in particular three, spaced-apart expandable units (20), and wherein the shell (10) comprises an expansion arrangement (54) arranged between two adjacent expandable units (20) 9. Heart assist device (1) according to any one of the preceding claims, wherein the at least one expandable unit (20) comprises a connection piece (24) arranged on the shell (10) for connection to a fluidic supply line (220) of a supply system (200) of the heart assist device (1).

10. Heart assist device (1) according to any one of the preceding claims, wherein the implant (100) further comprises at least one electrode web (30) to which at least one of the at least one electrode (31, 32) is attached.

11. Heart assist device (1) according to claim 10, wherein the electrode web (30) is arranged on an outer side (12) of the shell (10) and optionally, wherein the at least one electrode (31, 32) is embedded in the electrode web (30) such that the active side (31a, 32a) of the electrode (31, 32) protrudes from the electrode web (30).

12. A heart assist device (1) according to any one of claims 10 or 11, wherein two electrodes (31, 32) are attached to the electrode web (30) and optionally, wherein the two electrodes (31, 32) are arranged in opposite end regions (34, 36) of the electrode web (30).

13. Heart assist device (1) according to any one of the preceding claims, wherein the shell (10) comprises at least in sections a conductive region having a perforation (50) and / or a plurality of conductive elements in order to establish a fluidic and / or conductive connection between the inner side (11) of the shell (10) and the outer side (12) of the shell (10) and optionally, wherein the conductive region comprises a perforation (50) having a plurality of passages (52) between the inner side (11) and the outer side (12) of the shell (10).

14. A heart assist device (1) according to any one of the preceding claims, further comprising a supply system (200) connected to the implant (100), wherein the supply system (200) is led laterally away from the implant (100) in the proximal direction (2b).

15. Heart assist device (1) according to claim 14, wherein the supply line system (200) comprises at least one fluidic supply line (220) and at least one electrical supply line (37, 38) for supplying the implant (100) from a supply unit (300), wherein at least one of the three fluidic supply lines (220) is fastened to the implant (100) via a first fixing point (222) in order to guide the at least one fluidic supply line (220) along the shell (10) via the first fixing point (222).

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