DE102013200153A1 - Device for supporting pumping function of heart in human body, has pericardial closure for sealing break-through membrane and provided with first and second closure elements, which are provided with two disk shaped sealing lips - Google Patents

Abstract

The device (10) has a pericardial closure (5) for sealing a break-through membrane and provided with first and second closure elements, which are provided with two disk shaped sealing lips. The first closure element is coupled and secured with the second closure element with a mechanism. The mechanism comprises a screwing mechanism, a screw thread, a clamping mechanism and a bayonet fitting, where the device comprises a delivery system. The closure elements are made of metal or plastic. A shell (2) i.e. wire mesh, partly encloses the heart (61) and a casing is inserted into the shell. The closure elements are made of polyetheretherketone, polyamide, polyurethane, polyethylene, polypropylene, polycarbonate, polyethylene and terephthalate. An independent claim is also included for a tool for gripping closure elements.

Description

Summary

The present invention relates to a device for supporting the function of a heart. The device comprises a closure for sealing a membrane breakthrough, wherein the closure comprises a first closure element with a first sealing lip and a second closure element with a second sealing lip. The closure has a central lumen. The first closure element can be coupled to the second closure element.

background

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

Due to illness, the pumping function of a heart can be reduced, which is also called cardiac insufficiency. Heart failure is of great and growing importance from a medical as well as an economic point of view. In the second decade of this century, 23 million people around the world will suffer from heart failure and the annual incidence will reach 2 million people. In the US alone, approximately 5 million people are currently suffering from heart failure. Here, the annual incidence rate is approximately 550,000 people. Already in this decade alone in the US, the numbers in over-50s will double to more than 10 million. The same applies to the European continent.

The cause of heart failure may be impaired contractility or filling of the heart due to damage to the heart muscle. An increased blood pressure can lead to an increased pumping resistance, which can also have a negative effect on the pumping function of the heart. The pumping function of a heart may also be affected by leaky valves, e.g. a leaky aortic valve or mitral valve, be diminished. Impairment of the conduction in the heart may also result in reduced pumping of the heart. If the heart is restricted from the outside in its mobility, e.g. due to a fluid accumulation in the pericardium, this too can result in a reduced pumping function. Heart failure often leads to shortness of breath (especially in case of left heart failure) or to fluid retention in the lungs (especially in left heart failure) or in the legs or abdomen (especially in right heart failure).

Different types of heart failure can be treated with medication or surgery. Disturbances in the conduction can be treated under certain conditions with a pacemaker. A defective heart valve can be surgically replaced by a heart valve prosthesis. A reduced pumping power can be treated by implantation of a heart pump. One approach to treatment across the various causes of heart failure is to support the pumping function of the heart through an implant that applies mechanical pressure to the heart, thereby improving its pumping performance.

Previously known mechanical cardiac assist devices are disclosed, for example, in the US patents US 5,749,839 B1 and US 6,626,821 B1 and in the WO Application 00/25842 disclosed. These documents disclose mechanical cardiac assist devices which have the disadvantage that implantation of the device requires open chest surgery. The current support systems are complex and can only be implanted with a costly surgical operation. All of them are integrated into the patient's bloodstream. Improved centrifugal pumps or magnetically-mounted impeller systems continuously transport the blood. The contact of the blood with the alien surface of the systems poses a great technical and medical challenge. Common complications of these systems are strokes, bleeding and infections. They often lead to long-term hospitalization and frequent readmissions of patients who have already been discharged from the hospital.

The object of the present invention is to provide a cardiac assist device which does not have the disadvantages of the known cardiac assist devices.

The present invention relates to a device for supporting the function of a heart. In general, the device can be minimally invasively implanted using a catheter. The device generally has no direct contact with blood vessels and is not introduced into a vasculature.

Summary of the invention

The device for supporting the function of a heart is inserted between the heart and the pericardium. A cable with hydraulic, pneumatic and electrical lines runs through the pericardium and supplies the device for supporting the function of a heart. The pericardium is a connective tissue sac that surrounds the heart and the heart through a narrow overlay free movement possibility exists. It contains as a lubricant a serous fluid, which is also called liquor pericardii. To prevent this lubricant from flowing through the opening in the pericardium, which is necessary for the passage of the cable, and so that no other liquids or solids (such as cells, proteins, foreign bodies, etc.) can enter the pericardium, a pericardium closure will be applied around the cable. The cardiac assist devices known from the prior art do not have a pericardial closure.

The closure comprises a first closure element with a first sealing lip and a second closure element with a second sealing lip and has a central lumen. The first closure element can be coupled to the second closure element, for example with a screw mechanism, a clamping mechanism or a bayonet closure.

The first closure element and / or the second closure element with or without its sealing lips can be self-expandable. The first closure element or the sealing lip of the first closure element and the second closure element or the sealing lip of the second closure element can expand after introduction with the delivery system. This allows the pericardial closure to be minimally invasively implanted.

The first and / or second sealing lip may have increased flexibility with increasing radial distance from the central lumen. This ensures an exact fit to the pericardium. The increased flexibility can be achieved by an elastic material, by a variable thickness of the sealing lip, by material changes within the sealing lip, or by stiffening in or on the sealing lip. Stiffening of the sealing lip can be caused by applying or introducing material. In particular, concentric rings or radial struts of another material in the sealing lip can lead to stiffeners.

The device may comprise a cable which can be passed through the central lumen of the closure elements. On the lumen side, the device may comprise a seal on the first closure element which seals the cable against the closure element. This seal serves not only to seal, but also to fix (e.g., by friction) the cable to the pericardial seal.

Further features and advantages of the invention will become apparent from the following description and from the following drawings, to which reference is made.

Description of the drawings

1 shows a human torso with the device according to the invention, wherein a supply unit is extra-corporeal.

2 shows a human torso with the device according to the invention and a partially implanted supply unit.

3 shows a human heart with the device according to the invention.

4a and 4b show a section through the heart with the device according to the invention along the in 3 represented line AA.

5 shows a step of implantation of the device according to the invention.

6 shows a step of implantation in which a pericardial closure is not yet screwed.

7 shows a step of implantation in which a pericardial closure is screwed.

8th shows a partially expanded shell with a shell.

9a -C show different views of a closed pericardial closure.

10 shows a tool for closing a pericardial closure.

11 shows a plug system of the device according to the invention.

12a shows a heart with anatomical landmarks.

12b shows a section through the heart 12a ,

13a shows a 3D view of part of a heart with a coordinate system.

13b shows a 2D unroll of the 3D view 13a with a coordinate system.

14a shows a 3D view of a shell with augmentation and positioning units.

14b shows a 2D unrolling of the envelope with augmentation and positioning units 14a ,

15a Figures 3 b show a compressed and an expanded augmentation unit in the form of a chamber with a bellows-shaped section.

16a shows a 3D view of a shell with sensors and / or electrodes.

16b shows a 2D unwinding of the envelope with sensors and / or electrodes 16a ,

17 shows an embodiment of a shell with augmentation and positioning units.

18 shows an embodiment of a shell with sensors and electrodes.

Detailed description

The device according to the invention comprises a plurality of components, which are explained in more detail in the following sections, wherein embodiments of the individual components can be combined with each other.

1 shows an embodiment ( 10 ) of the device according to the invention in the implanted state. By way of example, the device according to the invention is implanted in a human body. However, the device according to the invention can also be implanted in an animal body, in particular in the body of a mammal, such as a dog, a cat, a rodent, a primate, a cloven-hoofed or an odd-toed ungulate. Depending on the species then special adjustments to the shape and operation of the device according to the invention may be necessary to meet anatomical and / or physiological needs of each species justice.

1 shows a human torso with the device according to the invention. The device consists of a shell ( 2 ), which is the heart ( 61 ) can at least partially enclose, wherein in the shell ( 2 ) Components are introduced that enhance the function of the heart ( 61 ) support. Furthermore, the device comprises a supply unit ( 30 ).

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

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

The shell ( 2 ) may further comprise at least one sensor and / or an electrode, by means of which at least one parameter of the heart ( 61 ) can be detected. The at least one sensor may be adapted to determine the heart rate, the ventricular pressure, the contact force between the heart wall and the at least one expandable unit, the systolic blood pressure or the diastolic blood pressure. The sensor may also be capable of measuring the pressure exerted by an expandable unit on a surface, the pH, the electrical resistance, the osmolarity of a solution, or the flow through a vessel. The at least one sensor can be in, on or on the shell ( 2 ) to be appropriate. Preferably, the at least one sensor is mounted on a shell, which in the shell ( 2 ) can be introduced. In addition to the at least one sensor or instead of the at least one sensor, the shell ( 2 ) also comprise at least one electrode capable of measuring a parameter such as the action potential on the myocardium during the excitation process or of stimulating a tissue with currents. The at least one sensor can also be an electrode. The at least one sensor and / or the at least one electrode will be explained in more detail in a later section of the description.

1 shows a supply unit ( 30 ) which can be worn outside the body. The supply unit can also be partially or completely implanted in the body, which will be explained in more detail in subsequent paragraphs. Is the supply unit ( 30 ) worn outside the body, it can be attached to a chest belt, to a hip belt or to a waist belt. The supply unit ( 30 ) has an energy storage, by means of which the at least one expandable unit can be driven. The energy store may be in the form of a rechargeable battery that provides electrical energy to expand the expandable unit. The accumulator can be changed. The supply unit ( 30 ) may also include an accumulator that provides a compressed gas to inflate an inflatable chamber. Suitable gases include compressed air, CO ₂ , or noble gases. The housing of the supply unit ( 30 ) itself can serve as an accumulator housing. The supply unit ( 30 ) may also include pumps, valves, sensors and displays. The supply unit ( 30 ) may further include a microprocessor adapted to receive and process data from the at least one sensor. Is the supply unit ( 30 ) carried outside the body, the energy to be supplied can be obtained by a direct connection via a cable ( 4 ), or connectionless by eg electromagnetic induction. The data from the at least one sensor can also directly via a cable ( 4 ) or connectionless via a wireless technology, such as bluetooth, be transmitted.

The device according to the invention may further comprise a cable ( 4 ) comprising the at least one expandable unit and / or the at least one sensor or the at least one electrode with the supply unit ( 30 ) connects. Is the supply unit ( 30 ) is connected directly to the at least one expandable unit and / or the at least one sensor or the at least one electrode, can be connected to a cable ( 4 ) are waived. If the at least one expandable unit is a mechanical unit that can transition from an unexpanded state to an expanded state or from an expanded state to a non-expanded state with the aid of electrical energy, the cable ( 4 ) Lines that are suitable for supplying the necessary energy from the supply unit ( 30 ) to the expandable unit. If the at least one expandable unit is a chamber that can be filled by means of a fluid, then the cable ( 4 ) at least one conduit which controls the flow of fluid from the supply unit ( 30 ) into the chamber. Preferably, the cable includes ( 4 ) In this case, at least one pneumatic or hydraulic line. When the device includes a sensor or an electrode, in or on the shell, the at least one lead leading to the sensor or the electrode may also be located in the cable (FIG. 4 ) be. Embodiments may also have separate cables for providing energy to the at least one expandable unit and to the at least one sensor or the at least one electrode.

The cable ( 4 ), which the supply unit ( 30 ) connects to the at least one expandable unit and / or the sensor or the electrode may be a single continuous cable or a multi-part cable. In the case of a continuous cable, a cable ( 4 ) are located on the at least one expandable unit and / or the at least one sensor or an electrode. At the end of the cable ( 4 ) can then be a plug part ( 90 ), which can be connected via the coupler ( 91 ) to the supply unit ( 30 ) can be connected. Alternatively, only at the supply unit ( 30 ) a cable with a plug part. In this case, the connection that can be coupled to the shell ( 2 ), the at least one expandable unit and / or the at least one sensor or electrode. In the case of a multi-part cable, a cable ( 4 ) with plug part ( 91 ) are attached to the at least one expandable unit and / or to the at least one sensor or an electrode and also a cable to the supply unit ( 30 ), at the end of which preferably also a plug part is located. The cable ( 4 ) will be explained in more detail in a later section of the description. The plug part ( 90 ) will be explained in more detail in a later section of the description.

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

In the 2 illustrated shell ( 2 ), the pericardial closure ( 5 ), and the cable ( 4 ) of the device are substantially the same as in 1 shown components match. The supply unit ( 31 ) may include an energy storage, by means of which the at least one expandable unit can be driven, which is in the shell ( 2 ) is located. The energy store may be in the form of a rechargeable battery that provides electrical energy to expand the expandable unit. The supply unit ( 31 ) may further include sensors and one or more microprocessors contain. If the at least one expandable unit consists of at least one chamber which can be filled with a fluid, then the supply unit ( 31 ) Pumps, valves, and a pressure accumulator included. The accumulator can provide a compressed gas to inflate an inflatable chamber can. Suitable gases include compressed air, CO ₂ , or noble gases. The housing of the supply unit ( 31 ) itself, can represent the accumulator housing. A preferred site for the implantation of the supply unit ( 31 ) is right-lateral in the chest cavity above the liver ( 62 ) and above the diaphragm ( 63 ). Alternatively or in addition to the accumulator in the supply unit ( 31 ), an accumulator ( 32 ) preferably right-laterally in the abdominal cavity below the diaphragm ( 63 ) and over the liver ( 62 ) are implanted. The accumulator ( 32 ) can with a hose ( 33 ), which is the diaphragm ( 63 ) penetrates, with the supply unit ( 31 ) get connected. The for the implementation of the hose ( 33 ) necessary opening in the diaphragm can be sealed with a lock. This closure may be similar to the pericardial closure described in this application. The supply unit can be connected with a cable ( 4 ) may be connected directly to the at least one expandable unit and / or the sensor or the electrode. Alternatively, at one end of the cable ( 4 ) are a plug part, which via a coupling connection to the supply unit ( 31 ) or to which at least one expandable unit and / or the sensor or electrode can be connected. The cable ( 4 ) preferably runs in the chest cavity above the diaphragm ( 63 ). In the case of a multi-part cable, a cable with plug part can be attached to the at least one expandable unit and / or the at least one sensor or an electrode, and also a cable with a couplable plug part to the supply unit ( 31 ).

Alternatively or in addition to one in the supply unit ( 31 ) accumulator can be an accumulator ( 34 ) are preferably implanted subcutaneously in the abdominal wall. The in the supply unit ( 31 ) energy can, for example, by electromagnetic induction from an extracorporeal control unit ( 35 ) transcutaneously to the accumulator ( 34 ) and by means of an electric cable ( 36 ) from the accumulator ( 34 ) to the supply unit ( 31 ) be transmitted. The extracorporeal control unit ( 35 ) may include, inter alia, a removable accumulator and / or a charger. In the extracorporeal control unit ( 34 ) may include, among other things, microprocessors and displays that may serve to monitor the system and display the operating status. The data from the at least one sensor can connectionless via a wireless technology, such as bluetooth, to and between the supply unit ( 31 ) and the control unit ( 34 ) be transmitted.

3 exemplifies a human heart ( 61 ) and a bowl ( 2 ), a case ( 7 ) with expandable units ( 71 . 72 ), a case ( 80 ) with sensors ( 81 ) and / or electrodes ( 82 ), a cable ( 4 ) with a plug part ( 90 ), a catheter ( 103 ) of a delivery system and a pericardial closure ( 5 ) of the device according to the invention.

The shell ( 2 ) is shown in this embodiment in the form of a wire mesh. Instead of a wire mesh, the shell ( 2 ) may alternatively be formed from a grid of struts. In this case, struts form a latticework with openings. The shell ( 2 ) can also consist of a continuous material, were removed from the parts, for example, the shell ( 2 ) consist of a tube or individually shaped shell, were formed in the holes or cut.

In the 3 illustrated shell ( 2 ) consists of a network of wires. The wires form crossing points that can be firmly connected together. For example, the wires can be welded together at the crossing points. The joining of the wires at crossing points increases the stability of the shell ( 2 ). The crossing points can not be connected to each other. This can increase the flexibility of the shell ( 2 ) and thus to an easier compressibility of the shell ( 2 ) to lead. This can be particularly helpful when the shell ( 2 ) in a delivery system with a catheter ( 103 ) of smaller diameter is to be introduced. The shell ( 2 ) may also be firmly connected to one another at some of the intersection points and may not be firmly connected to one another at other intersection points. By a suitable choice of intersection points, which are firmly connected to each other and crossing points, which are not firmly connected to each other, the stability and flexibility of the shell ( 2 ) be adjusted. Areas that require increased stability in the implanted state can be stabilized by connecting the wires at points of intersection. These may be, for example, areas that serve as abutments for expandable units ( 71 . 72 ) serve. Such abutments may be directly under an expandable unit ( 71 . 72 ) or next to areas with expandable units ( 71 . 72 ). Areas that require increased flexibility may be areas that need to be more compressed when inserted into a delivery system than other areas. Areas that require increased flexibility may also be areas where increased flexibility supports the natural movement of the heart. Does that exist? Bowl ( 2 ) not of a wire mesh, but of a latticework or a shell casing with holes, can also in these the stability and / or flexibility of the shell ( 2 ) are adapted to areas. Adjustments can be brought about in these cases by the choice of the strut width and / or the strut thickness, by the choice of the material used, by changes in the material in certain areas by the action of eg energetic radiation, such as heat. Preferably, the shell ( 2 ) Openings which are formed by the wires of a wire mesh, the struts of a latticework or the holes in a shell shell. These openings allow the compression of the shell ( 2 ), they allow the mass transfer from the inside of the shell ( 2 ) with areas outside the shell ( 2 ) and vice versa, they reduce the amount of material to be used for the shell ( 2 ) and they allow increased flexibility of the shell ( 2 ). Shapes, which are difficult to realize with continuous materials, are easier to form with braid or lattice-like structures. The openings may be square, diamond-shaped, round or oval. The apertures defined by the wires, the struts or the holes in a shell jacket have a diameter of about 1 mm to 50 mm, preferably 3 mm to 30 mm, preferably 5 mm to 20 mm. The diameter of an opening is defined as a pin opening, that is, the diameter of the opening represents the largest diameter of a cylindrical pin that can be passed through an opening (a cell, a hole).

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

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

The shell ( 2 ) can with a membrane ( 21 ), in particular with a membrane ( 21 ) made of polyurethane or silicone. Such a membrane can reduce the mechanical stress exerted by the shell ( 2 ) on the pericardium ( 6 ) or the heart muscle ( 61 ). Likewise, such a membrane ( 21 ) the biocompatibility of the shell ( 2 ) increase. The membrane ( 21 ) can on the inside or on the outside of the shell ( 2 ) to be appropriate. The membrane ( 21 ) can also by immersion of the mesh or lattice-like shell ( 2 ) are prepared in an elastomeric liquid and then cladding the grid or the braid. The openings of the mesh or grid can then be separated from the membrane ( 21 ). A membrane ( 21 ) on the mesh or grid can also be the abutment for an expandable unit ( 71 . 72 ) improve. Is, for example, an expandable unit ( 71 . 72 ) an inflatable chamber, so a membrane ( 21 ) over, on or on the mesh or grid to prevent portions of the chamber from being forced through the mesh or grid during expansion of the chamber. The membrane ( 21 ) can still be too large expansion of the shell ( 2 ), especially in the case of inflation of an inflatable chamber. A membrane ( 21 ) on a grid or braid can ensure that expansion of an expandable unit located on the grid or braid is only in a direction inwardly of the braid or grid. The membrane ( 21 ) does not hinder the compressibility of the shell ( 2 ) when introduced into a delivery system.

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

In the bowl ( 2 ) is the at least one expandable unit ( 71 . 72 ). 3 shows a bowl ( 2 ) into which a shell ( 7 ) with expandable units ( 71 . 72 ) is introduced in the form of inflatable chambers. The expandable unit ( 71 . 72 ) is replaced by a line ( 41 ) located in the cable ( 4 ) is located. The expandable unit ( 71 . 72 ) may be a hydraulic or a pneumatic chamber. The expandable unit ( 71 . 72 ) can directly on the shell ( 2 ) without a shell ( 7 ) are attached. The expandable unit ( 71 . 72 ) can also be applied to a case ( 7 ) and the envelope ( 7 ) can in the shell ( 2 ) be attached. The expandable unit ( 71 . 72 ) may be designed to apply pressure to the heart ( 61 ) exercise. This pressure may be a permanent pressure or it may be a periodic pressure. The device according to the invention may comprise various types of expandable units ( 71 . 72 ). The device may comprise at least one augmentation unit ( 71 ). The device may comprise at least one positioning unit ( 72 ). The augmentation unit ( 71 ) and / or the positioning unit ( 72 ) can directly on the shell ( 2 ) or on a sleeve ( 7 ), which are in the shell ( 2 ) is introduced.

An augmentation unit ( 71 ) is a unit that can be periodically expanded and relaxed, thus putting pressure on the heart ( 61 ) exercise. This pressure is preferably applied in areas on the heart muscle, under which there is a heart chamber. By applying pressure to a ventricle through the augmentation unit ( 71 ) the natural pumping motion of the heart ( 61 ) supports or replaces, and the blood in the heart ( 61 ) is pumped out of the chamber into the laxative artery. One from an augmentation unit ( 71 ) Pressure applied to a right ventricle results in ejection of the blood from the right ventricle into the pulmonary artery. One from an augmentation unit ( 71 ) pressure applied to a left ventricle results in ejection of the blood from the left ventricle into the aorta. The positioning of the at least one augmentation unit ( 71 ) in the bowl ( 2 ) will be explained in more detail in a later section of the description.

A positioning unit ( 72 ) is a unit that can also be expanded. Preferably, a positioning unit is more statically expanded than periodically during operation of the device to support the function of a heart. The positioning unit ( 72 ) can be expanded to fix the device to the heart and to ensure the fit of the device. With the help of a positioning unit ( 72 ) can also be responsive to changes in the heart muscle (eg, shrinkage of the heart muscle due to lack of fluid or expansion of the heart muscle due to fluid intake of the patient). If the heart muscle breaks down or over a period of time, a positioning unit can be further expanded and relaxed to ensure a perfect fit. The positioning unit ( 72 ) can also serve, for example, that the device does not lose contact with the heart wall over the duration of a heartbeat. Contact loss can lead to shock loading between the heart muscle and the device and / or malfunction of sensors ( 81 ) and / or electrodes ( 82 ). Not conclusively, the positioning unit ( 72 ) counteract the pathologically induced, progressive expansion of the damaged heart muscle in heart failure patients. The positioning of the at least one positioning unit ( 72 ) in the bowl ( 2 ) will be explained in more detail in a later section of the description.

At the bottom of the shell ( 2 ) may be an opening through which the line ( 83 ) of the at least one sensor ( 81 ) or the at least one electrode ( 82 ) and / or the line ( 41 ) of the at least one expandable unit ( 71 . 72 ) can be carried out. The opening may be at the lower distal end of the shell (FIG. 2 ) to be appropriate. Alternatively, the opening also on the side of the shell ( 2 ) to be appropriate. Is shown in 3 an opening at the lower distal end of the shell ( 2 ) through which a cable ( 4 ), all the lines ( 41 . 83 ) is guided. It is also possible to use several separate cables instead of one cable ( 4 ) are present. The multiple cables can pass through an opening in the shell ( 2 ) or through several openings of the shell ( 2 ). At the end of the cable ( 4 ) is a plug part ( 90 ), by means of which the at least one sensor ( 81 ) or the at least one electrode ( 82 ) and / or the at least one expandable unit ( 71 . 72 ) can be connected to a supply unit. Preferably, the shell ( 2 ) within the pericardium ( 6 ) appropriate. The cable ( 4 ) is then passed through the pericardium ( 6 ) guided. The device according to the invention may have a pericardial closure ( 5 ). This can be the opening of the pericardium ( 6 ) seal. The pericardium ( 6 ) is a connective tissue sac containing the heart ( 61 ) and the heart ( 61 ) gives free movement possibility by a narrow sliding layer. It contains as a lubricant a serous fluid, which also contains CSF called pericardii. So that this lubricant is not through the cable opening from the pericardium ( 6 ) and thus no other liquids or solids (such as cells, proteins, foreign bodies, etc.) into the pericardium ( 6 ), a pericardium seal ( 5 ) around the cable ( 4 ). The pericardial closure ( 5 ) seals the opening of the pericardium ( 6 ) to the cable ( 4 ). The pericardial closure ( 5 ) may comprise a first closure member having a first sealing lip and a second closure member having a second sealing lip. Through a central lumen of the closure, a cable ( 4 ) be performed. The first sealing lip and / or the second sealing lip can seal off the pericardial opening. There may be an additional sealing element in the central lumen 4 ) against the pericardial closure ( 5 ) and optionally fix it. The first and second closure elements can be coupled. Preferably, the first and the second closure element can be secured with a mechanism. Possible mechanisms for securing the closure elements are screw mechanisms, clamping mechanisms or a bayonet closure. The first closure element and / or the second closure element can be expandable, preferably self-expandable. The pericardial closure ( 5 ) will be explained in more detail in a later section of the description.

4a and 4b show a section through the heart ( 61 ) and a part of the device for supporting the function of a heart ( 61 ) along the line AA in 3 , From outside to inside the following layers are shown: The shell ( 2 ) with a membrane ( 21 ), a case ( 7 ) with at least one expandable unit ( 71 . 72 ), a case ( 80 ) with at least one sensor ( 81 ) or an electrode ( 62 ) and the heart ( 60 ) in transverse section. Exemplary are three augmentation units ( 71 ) and three positioning units ( 72 ). In 4a are the expandable units ( 71 . 72 ) in the unexpanded state. In 4b are the augmentation units ( 71 ) drawn in an expanded state. The at least one expandable unit ( 71 . 72 ) is located in a region adjacent to a heart chamber. An expansion of the at least one expandable unit ( 71 . 72 ) can reduce the volume of the ventricle and thus leads to an ejection of blood from the chamber. The at least one sensor ( 81 ) or the at least one electrode ( 82 ) is attached at a position where at least one parameter of the heart ( 61 ) can be measured. An electrode ( 82 ) may be attached to a site where the heart muscle can be stimulated. In the 4a and 4b are exemplary four sensors ( 81 ) in the shell ( 80 ) and two electrodes ( 82 ) on the inside of the envelope ( 80 ).

5 shows a delivery system ( 100 ) by means of which the device for supporting the function of a heart can be implanted. The feeding system ( 100 ) consists of a catheter ( 103 ), which has a lumen. Preferably, the catheter is ( 103 ) an elongated tubular member into which the device for supporting the function of a heart in a compressed state can be inserted. The cross-section of the catheter ( 103 ) and / or the lumen may be round, oval or polygonal. The feeding system ( 100 ) may further comprise a guidewire ( 101 ) and / or a dilatation element. The dilation element may be a soft conical tip ( 102 ) with shank. Through a puncture of the chest wall ( 65 ) between the ribs ( 64 ) and the pericardium ( 6 ) the guide wire ( 101 ). The soft conical tip ( 102 ) may have a round, oval or polygonal lumen in the middle. The soft conical tip ( 102 ) can over the guide wire ( 101 ) and the puncture can be dilated without injuring the epicardium. Due to the dilated opening, the distal section of the catheter ( 103 ) of the delivery system ( 100 ) are passed. At the distal end of the catheter ( 103 ), a first closure element ( 51 . 52 ) of the pericardial closure or otherwise secured. For example, the catheter ( 103 ) to one at the end of the first closure element ( 51 . 52 ) cone ( 55 ) be plugged. Not shown is another embodiment in which a cone is located on the side of the catheter and the first closure element can then be attached to this. The catheter ( 103 ) with the fastened first closure element ( 51 . 52 ) of the pericardium closure can be over the shaft of the soft tip ( 102 ) and into the pericardium ( 6 ) are introduced.

Alternatively, the catheter ( 103 ) and the first closure element ( 51 . 52 ) of the pericardial closure are uncoupled parts. In this case, initially only the catheter ( 103 ) into the pericardium ( 6 ) and the first closure element ( 51 . 52 ) can then enter the pericardium via the catheter ( 6 ) or through the lumen of the catheter ( 103 ) in the pericardium ( 6 ). The first closure element ( 51 . 52 ) may be a self-expandable closure element and may be in the pericardium ( 6 ) unfold. Alternatively, a non-expandable part ( 51 ) of the first closure element a self-expandable sealing lip ( 52 ) or a sealing lip ( 52 ), which during insertion of the first closure element ( 51 . 52 ) and in the pericardium ( 6 ) spreads. The first closure element ( 51 . 52 ) can expand to a mushroom-shaped or umbrella-like shape. A second closure element ( 53 . 54 ) can be delivered via the catheter ( 103 ) or through the catheter ( 103 ) be applied. For example, the second closure element ( 53 . 54 ) over the catheter ( 103 ) of the delivery system ( 100 ) to the distal end of the delivery system ( 100 ) and can then with the first closure element ( 51 . 52 ). The second closure element ( 53 . 54 ) may be expandable or non-expandable. The second closure element ( 53 . 54 ) can with the first closure element ( 51 . 52 ) can be coupled. Preferably, the second closure element ( 51 . 52 ) is self-expandable and may take on a mushroom-shaped or umbrella-like shape in an expanded form. The second closure element ( 53 . 54 ) can with the first closure element ( 51 . 52 ). Shown in 5 is a screw mechanism. Other mechanisms for securing the closure elements ( 51 . 52 . 53 . 54 ) comprise a clamping mechanism or a bayonet lock. After securing the closure elements ( 51 . 52 . 53 . 54 ), the catheter ( 103 ) of the delivery system ( 100 ) still on the cone ( 55 ) of the first closure element ( 51 ) or in the lumen of the closure element ( 51 . 52 ) remain. After the guidewire ( 101 ) and the soft tip with shank ( 102 ) are withdrawn from the catheter, the shell can be connected to the at least one sensor or the at least one electrode and / or with the at least one expandable unit through the lumen of the catheter ( 103 ) are introduced. The shell is preferably self-expanding and encloses the heart after expansion ( 61 ) at least in part. At the lower end of the shell may be a plug part or a cable with a plug part. The supply unit can be attached directly to the shell or connected to the shell via a cable. After feeding the shell, the delivery system ( 100 ) are removed. For this, the feed system ( 100 ) and / or on the catheter ( 103 ) a predetermined breaking point ( 104 ) are located. Preferably there is one or more predetermined breaking points ( 104 ) along a longitudinal axis of the delivery system ( 100 ). The breaking point ( 104 ) can represent a predetermined breaking line. Is the delivery system ( 100 ) along a predetermined breaking point ( 103 ), the delivery system ( 100 ), unrolled and removed. The feeding system ( 100 ) can also grip elements ( 105 ), by means of which a force on the delivery system ( 100 ) can be exercised. Preferably, with the gripping elements ( 105 ) one sideways from the catheter ( 103 ) of the delivery system ( 100 ) directed force which is suitable, the predetermined breaking point ( 104 ) break up.

6 shows a step of implantation of the device according to the invention. After the first closure element ( 51 . 52 ) in the pericardium ( 6 ) has taken the expanded form, the shell ( 2 ), which is preferably self-expanding, through the lumen of the catheter ( 103 ) of the delivery system and the lumen of the first closure element ( 51 ) are passed. After at least a part of the shell ( 2 ) with the at least one sensor or the at least one electrode and / or the at least one expandable unit in the pericardium ( 6 ), the expansion of the shell ( 2 ). Shown in 6 is also the second closure element ( 58 . 59 ) before it with the first closure element ( 51 . 52 ) was coupled. The second closure element ( 58 . 59 ) is in this embodiment an annular element ( 58 ), eg a nut, on whose distal side a sealing disc ( 59 ) can be attached. The second closure element ( 58 . 59 ) may be expandable or non-expandable. The second closure element ( 58 . 59 ) can be placed on the catheter ( 103 ) are moved. In this embodiment, the first ( 51 . 52 ) and the second closure element ( 58 . 59 ) Threaded sections which can be screwed together.

7 shows a step of implantation of the device according to the invention. In this embodiment, the first closure element ( 51 . 52 ) with the second closure element ( 53 ) coupled. The pericardium ( 6 ) may be sealed thereby. The expandable shell ( 2 ) is partially in the pericardium ( 6 ) and can be expanded. 7 shows marks ( 22 . 23 . 24 ) on the shell ( 2 ) are mounted. The device according to the invention generally contains at least one marker ( 22 . 23 . 24 ), the correct placement of the shell ( 2 ). The mark ( 22 . 23 . 24 ) may be an optical mark, in particular a color mark. The mark ( 22 . 23 . 24 ) may be a phosphorescent or fluorescent label that facilitates its perception in a dark environment. Such environments can be in the operating room itself and can be caused by, among other things, shadows. Such environments can also be inside the body of a patient. The mark ( 22 . 23 . 24 ) can be made of a material that can be represented by means of imaging techniques. Suitable imaging techniques include X-ray, CT, and MRI. The mark ( 22 . 23 . 24 ) may be formed of a more radiopaque material than the material of adjacent regions. The mark ( 22 . 23 . 24 ) may take a mark in the form of a point, a circle, an oval, a polygon, or the shape of a letter. Other shapes may be areas created by joining dots. For example, the shape may be a crescent or a star. The mark ( 22 . 23 . 24 ) can on the shell ( 2 ) or mounted on a sleeve. The marker may be in the form of a line. The line can be from an upper edge of the shell ( 2 ) go out. The line can be from an upper edge of the shell ( 2 ) too a point at the lower tip of the shell ( 2 ). The line can be from the upper edge of the shell perpendicular to the lower tip of the shell ( 2 ). The starting point of the line at the top of the shell ( 2 ) may be at a site that is near or at an area equal to the septum of the heart when implanted. The mark ( 22 . 23 . 24 ) may be at intersections of the mesh or grid. Does the shell ( 2 ) from a shell casing into which holes have been formed, the marking ( 22 . 23 . 24 ) are incorporated into the shell casing. For example, a hole can be made with a predefined shape, which can then be used as a marker ( 22 . 23 . 24 ) serves.

The delivery system and / or the catheter ( 103 ) of the delivery system, one or more markings ( 106 ). A marker ( 106 ) on a feeding system may be shaped like a mark on a tray. The mark ( 106 ) can have the shape of a point or the shape of a line. A marker ( 106 ) in the form of a line may be a line at least in part describing a circumference of the delivery system. A marker ( 106 ) in the form of a line may be a longitudinal line along an axis of the delivery system. A marker ( 106 ) in the form of a line can be a straight line or a meandering line. A marker ( 106 ) in the form of a line, one on a catheter ( 103 ) of a feed system be an oblique line. A marker ( 103 ) can facilitate the orientation of the delivery system during implantation. A marker ( 103 ) on or on the delivery system may be in registry with a line on or on a medical implant. For example, the medical implant may be a device for supporting the function of a heart that can be compressed. In a compressed state, the device can be introduced into a delivery system. One or more markers ( 22 . 23 . 24 ) on or on the device may be marked with one or more markings ( 106 ) are brought to coincide on or at the feed system. Such markings ( 22 . 23 . 24 . 106 ) facilitate the orientation of a medical implant. Markings ( 22 . 23 . 24 ) may also be along an axis of a medical implant. Such markings ( 22 . 23 . 24 ) may be helpful to track the progress of deploying a medical implant from a delivery system. The delivery system and / or a catheter ( 103 ) may be made of a transparent material that allows the medical implant to be perceived during insertion.

8th shows a step of implantation of the device according to the invention. In this example, the first closure element ( 51 . 52 ) and the second closure element ( 53 ) of the pericardial closure coupled together. The device for supporting the function of a heart has already been partially deployed from the delivery system. Shown is a self-expanding shell ( 2 ). The shell ( 2 ) is formed in this embodiment of a wire mesh, which at the top and / or at the bottom of the shell ( 2 ) Loops ( 26 . 28 ) having. The shell ( 2 ) can also be formed from a grid structure and can then struts in the form of ironing at the top and / or at the bottom of the shell ( 2 ) exhibit. Is the shell ( 2 ) are formed from a shell casing into which holes have been formed, the shell ( 2 ) at the upper edge and / or at the lower edge such that at least one bracket at the upper edge and / or at the lower edge of the shell ( 2 ) is located. In the 8th illustrated shell ( 2 ) comprises a casing ( 80 ), which are in the shell ( 2 ) is introduced. Between the shell ( 80 ) and the shell ( 2 ) may be a shell with at least one expandable unit. One or both sleeves can be attached to the loops ( 26 . 28 ) or ironing the shell ( 2 ) are attached. In particular, a shell on the loops ( 26 . 28 ) or ironing the shell ( 2 ) are hung. In such a case, the envelope ( 80 ) at least one bag ( 27 ), which via at least one loop ( 26 . 28 ) or at least a strap can be slipped. Another embodiment may include a shell ( 80 ), which is everted at its upper edge and / or at the lower edge. This eversion may be one around the whole or around part of the envelope ( 80 ) circulating bag ( 27 ) formed in the upper edge and / or the lower edge of the shell ( 2 ) can be hung. In 8th shows the shell ( 2 ) several markings ( 22 . 23 . 24 . 25 ) on. As already described, these markings ( 22 . 23 . 24 . 25 ) take different forms or positions. In the present case, the marks ( 22 . 23 . 24 . 25 ) at an upper edge and at the lower tip of the shell ( 2 ) appropriate.

9a C show different views of a pericardium closure ( 5 ). The pericardial closure ( 5 ) is used to avoid the loss of pericardial fluid, or the ability to apply artificial pericardium liquid, even with the addition of drugs or other therapeutic agents. The avoidance of loss of pericardial fluid also serves to avoid adhesions of the system with the epicardium. The pericardial closure ( 5 ) generally consists of a first closure element ( 51 ) and a second closure element ( 52 ). The first closure element ( 51 ) has a central lumen and the second closure element ( 53 ) has a central lumen. The first closure element ( 51 ) can with the second closure element ( 53 ) can be coupled. After coupling the first closure element ( 51 ) with the second closure element ( 52 ), the coupled pericardial closure ( 5 ) through the pericarctic closure ( 5 ) extending lumen. The lumen can only be separated from the central lumen of the first closure element (FIG. 51 ) or the lumen can exclusively from the central lumen of the second closure element ( 53 ). In another embodiment, the lumen may also consist of the two lumens of the two coupled closure elements (FIG. 51 . 53 ). In the lumen, a gasket, an O-ring, a labyrinth seal or other sealing element ( 56 ) are located. A sealing element ( 56 ) in the lumen of the pericardium closure, the pericardial closure ( 5 ) against a through the pericardial closure ( 5 ) seal the projecting object. For example, a cable through the pericardial closure ( 5 ), which then against the pericardial seal ( 5 ) is sealed. A sealing element ( 56 ) in the lumen can serve not only for sealing, but also for fixing an object protruding through the lumen of the pericardial closure. The sealing element ( 56 ) can on both closure elements ( 51 . 53 ) or only on one of the two closure elements ( 51 . 53 ) to be appropriate.

The first closure element ( 51 ) can with the second closure element ( 53 ) are secured by means of a mechanism. A mechanism for securing a first closure element ( 51 ) with a second closure element ( 53 ) may comprise a screw mechanism or a clamping mechanism. A mechanism for securing a first closure element ( 51 ) with a second closure element ( 53 ) may also include a bayonet lock. The first closure element ( 51 ) and the second closure element ( 53 ) can be made of the same material or of different materials. Suitable materials for the first closure element ( 51 ) and / or the second closure element ( 53 ) include plastics, metals, ceramics or combinations thereof.

At the first closure element ( 51 ), a first sealing lip ( 52 ) to be appropriate. The first sealing lip ( 52 ) may be part of the first closure element ( 51 ) or it can be attached to the first closure element ( 51 ). At the second closure element ( 53 ), a second sealing lip ( 54 ) to be appropriate. The second sealing lip ( 54 ) may be part of the second closure element ( 53 ) or it can be attached to the second closure element ( 53 ). The first sealing lip ( 52 ) and the second sealing lip ( 54 ) may be formed of the same material or of different materials. One or both sealing lips ( 52 . 54 ) can be part of the respective closure element ( 51 . 53 ) and of the same material as the associated closure element ( 51 . 53 ). The first sealing lip ( 52 ) and / or the second sealing lip ( 54 ) may be molded from plastic (preferably an elastomer), rubber, rubber, silicone, latex or a combination thereof. The first sealing lip ( 52 ) and / or the second sealing lip ( 54 ) may be disc-shaped. The first sealing lip ( 52 ) and / or the second sealing lip ( 54 ) may have a concave or convex bend. Curved sealing lips ( 52 . 54 ) can adapt better to the anatomical conditions. The pericardium has a convex shape in the area of the apex of the heart. By the sealing lips ( 52 . 54 ) have a bend in the form of the anatomically present shape of the pericardium, an improved anatomical fit of the pericardial closure ( 5 ) can be achieved.

Likewise, with curved sealing lips ( 52 . 54 ) improved sealing properties can be achieved. The first sealing lip ( 52 ) and / or the second sealing lip ( 54 ) may have reinforcements. With increasing radial distance from the lumen of the pericardial seal to the outside, the first sealing lip ( 52 ) and / or the second sealing lip ( 54 ) have increased flexibility. Increased flexibility in edge regions of a sealing lip ( 52 . 54 ), the sealing properties of the sealing lip ( 52 . 54 ) and also the anatomically correct positioning of the sealing lip ( 52 . 54 ). Increased flexibility in edge regions of a sealing lip ( 52 . 54 ) can be achieved by the choice of materials. Each of the sealing lips ( 52 . 54 ) may consist of one material or of several materials. Reinforcements in a sealing lip ( 52 . 54 ) can be concentric reinforcements or radial reinforcements. Reinforcements can be achieved by varying material thicknesses or by introducing a reinforcing material. The reinforcing material may be the same material as the base material of the sealing lip ( 52 . 54 ) which has been transferred to another form of material. Alternatively, regions that are not to be reinforced may be weakened by transferring the material of the sealing lip ( 52 . 54 ) in a weaker form of the material. A weakening of the material can be brought about by the action of energetic radiation, such as heat. Reinforcements of the material can also be achieved by applying material, wherein the applied material the same material as the base material of the sealing lip ( 52 . 54 ), or wherein the applied material is a different material than the base material of the sealing lip ( 52 . 54 ). Suitable materials for reinforcing parts of a sealing lip ( 52 . 54 ) are metals, ceramics, rubber and or a combination thereof.

On one of the two closure elements ( 51 . 53 ) may be a coupling mechanism, the coupling of a closure element ( 51 . 53 ) with the delivery system or a catheter of the delivery system. Of the Coupling mechanism may for example consist of a cone ( 55 ) consist of the first closure element ( 51 ) on which the delivery system or a catheter of a delivery system can be clamped. The clamping effect can be achieved for example by the diameter of the cone ( 55 ) is greater than the luminal diameter of the delivery system. The coupling mechanism for coupling the pericardial closure ( 5 ) with the feed system, can also be on the second closure element ( 53 ) are located. The coupling mechanism can also be used as a separate component next to the closure elements ( 51 . 53 ) and the feed system with one of the two closure elements ( 51 . 53 ) of the pericardial closure ( 5 ) connect. Other embodiments of the coupling mechanism include, among other things, a non-conical (for example, cylindrical) extension on one of the closure elements (FIG. 51 . 53 ) to which the delivery system can be applied or adhered, or also an embodiment in which the catheter of the delivery system and a closure element constitute a single integral part. In the latter embodiment, after successful insertion and securing of the pericardium closure ( 5 ) the catheter by means of a predetermined breaking point of the closure element ( 51 . 53 ) of the pericardial closure ( 5 ) are separated.

On one or both closure elements ( 51 . 53 ) engaging elements ( 57 ) are located. These engaging elements ( 57 ) can be used to apply a force to one or both closure elements ( 51 . 53 ) which is suitable for the closure elements ( 51 . 53 ) and / or secure. Engaging elements ( 57 ) on one or both closure elements ( 51 . 53 ) can be holes, indentations or elevations. The engaging elements ( 57 ) can circulate around the closure element ( 51 . 53 ) are mounted at the same distance from each other. The circumferential distance between the engaging elements ( 57 ) can also be different. In the 9a -C are six engaging elements ( 57 ) are shown at a uniform circumferential distance from each other. On the annular closure element ( 53 ) are the six engaging elements ( 57 ) at an angular distance of about 60 °. With two, three, four, five, six, eight or more equally spaced engaging elements ( 57 ) can be the angular distance respectively 180 °, 120 °, 90 °, 72 °, 60 °, 45 ° or less. The engaging elements ( 57 ) can also be arranged irregularly.

10 shows a pericardial closure ( 5 ) and a tool ( 11 ) for securing a pericardial closure ( 5 ). The in 10 illustrated pericardial closure ( 5 ) is essentially the same as in 9 shown closure match. The tool ( 11 ) is exemplified as an elongated tubular tool. At the distal end of the tool ( 11 ) there are elements ( 111 ) which at least partially with the engaging elements ( 57 ) a closure element ( 53 ) can be engaged. In the in 10 embodiment shown are in the tubular tool ( 11 ) at the distal end six inwardly facing elevations ( 111 ) with the six engaging elements ( 57 ) of the closure element ( 53 ), in this case six indentations on the closure element ( 53 ) can be engaged. The tool ( 11 ) has essentially the same number of elements ( 11 ), which are complementary to the engaging elements ( 57 ) of the closure element ( 53 ) are. This in 10 illustrated tool ( 11 ) is a tubular tool that consists of a completely encircling tube. The tubular element of the tool ( 11 ) can also be a half-tube, quarter-tube, or a third-tube. In extreme cases, instead of the tube, only one stem or several stems may be attached to a distal annular tool. A stem may extend from the annular tool in the longitudinal direction. A stem may also extend laterally away from a longitudinal axis of the tool. Other not shown embodiments of the tool ( 11 ) may be in the form of a modified ring spanner or a modified spanner.

11 shows a plug system consisting of two plug parts ( 90 . 92 ). The device for supporting the function of a heart consists of a shell with at least one sensor or at least one electrode and / or at least one expandable unit, wherein the at least one sensor or electrode and / or the at least one expandable unit is connected to a supply unit. The at least one sensor or the at least one electrode and / or the at least one expandable unit can be connected directly to the supply unit. The at least one sensor or the at least one electrode and / or the at least one expandable unit can be connected via a cable (FIG. 4 ) are connected to the supply unit. The at least one sensor or the at least one electrode and / or the at least one expandable unit can be connected via the cable (FIG. 4 ) may be connected directly to the supply unit or the at least one sensor or the at least one electrode and / or the at least one expandable unit may be connected to the supply unit. The supply unit can be a plug part ( 92 ). The plug part ( 92 ) can be attached directly to the supply unit. The plug part ( 92 ) can be connected via a cable ( 4 ) be connected to the supply unit. The at least one sensor or the at least one electrode and / or the at least one expandable unit can be a cable ( 4 ). At the end of the cable ( 4 ), a plug part ( 90 ) be. The Plug part ( 90 ) at the end of the cable of the at least one sensor or the at least one electrode and / or the at least one expandable unit can be connected to the plug part ( 92 ) of the supply unit are coupled. The plug part ( 90 ) of the sensor or the electrode and / or the at least one expandable unit may be a male plug part or a female plug part. A female plug part on the side of the sensor or the electrode and / or the at least one expandable unit may be advantageous since, unlike the male plug part, the female plug part does not have any pins ( 951 ) or other connections that protrude and break. If the replacement of the supply unit is necessary, the plug system must be decoupled and a new supply unit in the plug part ( 90 ) of the sensor or the electrode and / or the at least one expandable unit can be coupled. This can lead to breakage of pins ( 951 ) or other connections. Are these pins ( 951 ) or connections on a male connector part on the side of the shell with the at least one sensor or the at least one electrode and / or the at least one expandable unit, an exchange of the shell may be required. A female plug part on the side of the shell with the at least one sensor or the at least one electrode and / or the at least one expandable unit may be advantageous, since breakage of pins ( 951 ) or other connections on a female plug part can not occur. The plug system ( 90 . 92 ) generally consists of two connector parts. The device according to the invention may consist of a plug system ( 90 . 92 ) consist of the at least one sensor or the at least one electrode and / or the at least one expandable unit or of a plurality of plug systems. If multiple plug systems used, a plug system for electrical cables and a connector system for hydraulic and / or pneumatic lines may be present. This in 11 illustrated connector system ( 90 . 92 ) is a connector system comprising terminals for the supply of the at least one sensor or the at least one electrode and the at least one expandable unit. The number of connections depends on how many sensors or electrodes and how many expandable units are used, the number need not correlate directly with the number of sensors or electrodes and / or the number of expandable units. Forks of lines are on both sides of the connector system ( 90 . 92 ) and a pneumatic or hydraulic line may supply one, two, three, four, five, six or more inflatable chambers. The filling of the multiple chambers by a line does not have to be parallel, it can also be done individually by controllable valves. Similarly, an electrical lead in the cable can be used for multiple sensors or electrodes and switches can individually control circuits. This in 11 illustrated connector system ( 90 . 92 ) comprises four hydraulic or pneumatic connections ( 93 . 94 ) and a connection for electrical lines ( 95 . 96 ). The in 11 shown connection for electrical lines ( 95 . 96 ) 16 Connection elements in the form of pins ( 951 ) and pin sockets ( 961 ) on. More or less connections for electrical lines ( 95 . 96 ) and / or pneumatic or hydraulic lines ( 93 . 94 ) may be present in a connector system. One, two, three, four, five, six, seven, eight, nine, or ten connections for pneumatic or hydraulic lines ( 93 . 94 ) are present. There may be one, two, three, four, five, six, seven, eight, nine, ten, twelve, fourteen, sixteen, twenty or more electrical wiring connections ( 95 . 96 ) are present. One, two, three, four, five, six, seven, eight, nine, ten, twelve, fourteen, sixteen, twenty or more terminal elements in the form of pins ( 951 ) and pin sockets ( 961 ) within an electrical connection for electrical lines ( 95 . 96 ) are present. The number of connection elements in the form of pins ( 951 ) and pin sockets ( 961 ) but for the respective connection pair for electrical lines ( 95 , 96) identical. Each of the connections ( 93 . 94 . 95 . 96 ) in one or both of the plug parts of the plug system ( 90 . 92 ) can have its own seal ( 931 . 952 ) to have. The seal ( 931 . 952 ) of the individual connections ( 93 . 94 . 95 . 96 ) may be a sealing tape or a sealing ring. The plug system ( 90 . 92 ) can additionally or only a seal inside the plug system ( 973 ) or around the connector system. A seal over the plug system may be a sealing tape or a gasket. The plug parts ( 90 . 92 ) can be coupled together to the plug system ( 90 . 92 ) to build. The plug parts ( 90 . 92 ) can also be a guide nose ( 972 ) and a guide groove ( 974 ). The guide nose ( 972 ) and the guide groove ( 974 ) can prevent incorrect coupling of the two connector parts and / or rotation of the connector parts during the coupling process. It can also be two, three or more guide lugs ( 972 ) and guide grooves ( 974 ) are present. In the case of two or more guide dogs ( 974 ) and guide grooves ( 974 ) are unequal distances between the individual guide lugs ( 974 ) and guide grooves ( 974 ) used. The coupled connector parts ( 90 . 92 ) can also be used with a mechanism ( 971 ). Such a mechanism ( 971 ) may be a screw mechanism or a clamping mechanism or a bayonet lock. A mechanism for securing the docked connector system ( 90 . 92 ) may also be an externally attached to the connector system union nut, clamp, latch or snap lock. Saving the plug system ( 90 . 92 ) is advantageous because an accidental or accidental partial or total opening of the plug system ( 90 . 92 ) can interrupt the supply of the at least one sensor or the at least one electrode and / or the at least one expandable unit.

12 shows a model for creating a coordinate system. The creation of a coordinate system may facilitate the production of a device for supporting the function of a heart, since the position for the at least one sensor or electrode and / or the at least one expandable unit and / or the at least one marker can be precisely defined. 12a shows a heart ( 61 ) with anatomical landmarks. Shown is the heart ( 61 ) with the aortic arch (AO) originating from the left ventricle (LV) (with the branching head, neck and clavicle arteries (TR, CL, SCL)) and the pulmonary artery (PU) originating from the right ventricle (RV). Also shown are parts of the inferior vena cava (IVC) and the superior vena cava (SVC). The dashed line ( 601 ) represents the height of the valve plane. By dropping the solder ( 603 ) from this level ( 601 ) through the most distal point of the apex, the point ( 604 ) defines the apex of the heart. The device according to the invention consists of a shell into which a shell with at least one sensor or an electrode and / or a shell with at least one expandable unit can be introduced. The dimension of the shell and / or the shell may be designed such that the upper edge of the shell ( 602 ) parallel to the valve plane extends with a distance in the direction of the apex downwardly offset distance from the valve plane of 1 mm to 30 mm, 3 mm to 20 mm, 5 mm to 10 mm, preferably 5 mm. The upper edge of the shell is in 12a with the line ( 602 ). The lower edge of the shell ( 605 ) and / or sheath may be parallel to the valve plane at a distance from the most distal point (FIG. 604 ) from 1 mm to 30 mm, 3 mm to 20 mm, 5 mm to 10 mm, preferably 5 mm. 12b shows a sectional plane BB along the in 12a represented line ( 602 ), ie along the line that corresponds to the upper edge of the shell. In 12b The right ventricle (RV) and left ventricle (LV), heart wall, and septal wall separating the heart chambers are shown. The points ( 608 ) and ( 609 ) are defined as the crossing points of the midlines of the heart wall with the septal wall. The point ( 608 ) is also referred to as an anterior junction of the midlines of the heart wall with the septal wall. The point ( 609 ) is also referred to as the posterior junction of the midlines of the heart wall with the septal wall. The center point on a line containing the points ( 608 ) and ( 609 ) is connected as a point ( 607 ) Are defined. A polar coordinate system can be defined using these points. The z-axis ( 606 ) of the polar coordinate system is defined as the connecting line of the most distal point ( 604 ) with the center ( 607 ) of the line containing the points ( 608 ) With ( 609 ) connects. The circumferential direction of the coordinate system is denoted by the reference symbol ( 610 ) and is defined as an angle φ, where one of the z-axis ( 606 ) radially through the anterior crossing point ( 608 ) extending line is defined as φ = 0 °.

13 shows a shell and / or shell with the above in connection with 12 described coordinate system. 13a shows a 3D model ( 611 ) a shell or shell with the z-axis ( 606 ) passing through the most distal point ( 604 ) and the midpoint ( 607 ) of the line containing the points ( 608 ) With ( 609 ) connects. The points ( 608 ) respectively. ( 609 ) are the anterior and posterior crossing points of the center lines of the heart wall with the septal wall, whereby the point ( 608 ) the φ = 0 ° line is laid. The dashed line representing the points ( 608 ) With ( 609 ) along an outer circumference of the shell or shell, represents the position of the septal wall of the heart projected onto the shell / shell. At the upper edge of the shell or shell, the angular dimensions of φ = 0 ° are indicated in 30 ° steps Angle as seen from above rise counterclockwise. Projected on the shell / shell longitudinal lines ( 613 ) run along these angles up to the apex ( 604 ). The angle of φ = 360 ° then corresponds again to the angle of φ = 0 °. Contour lines ( 614 ) are drawn at intervals of 15 mm increments. The contour lines ( 614 ) and planes are perpendicular to the z-axis ( 606 ). The dotted-dashed line ( 615 ) represents a section line at which the 3D shape ( 611 ) can be cut open and then unrolled. 13b shows an unrolled shell or shell ( 612 ), along the line ( 615 ) in 13a was cut and then rolled out. In the 13b positions shown ( 608 . 609 ) and lines ( 613 . 614 . 615 . 616 ) represent the same positions and lines as in 13a are shown.

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

In 14a is the shell ( 7 ) with at least one expandable unit ( 71 . 72 ) as a shell ( 7 ) shown with a variety of chambers. 14b shows a 2D unroll of the 3D model 14a , In the 14b shown unwinding corresponds essentially to in connection with 13b Explained unrolling of a 3D model. Unlike in 13a is the 3d model in 14a rotated so that a view from above into the shell ( 7 ). In the 14a and 14b are exemplary four expandable units ( 71 . 72 ), of which three augmentation units ( 71 ) and a positioning unit ( 72 ). The expandable units ( 71 . 72 ) may be structurally similar, but may serve various purposes as described above.

Generally, an augmentation unit ( 71 ) are periodically expanded and relaxed so that a pressure on the heart can be exercised. This pressure is preferably applied in areas on the heart muscle, under which there is a heart chamber. By applying pressure to a ventricle through the augmentation unit ( 71 ) supports or replaces the heart's natural pumping motion, and the blood in the heart is pumped from the ventricle to the laxative artery. One from an augmentation unit ( 71 ) Pressure applied to a right ventricle results in ejection of the blood from the right ventricle into the pulmonary artery. One from an augmentation unit ( 71 ) pressure applied to a left ventricle results in ejection of the blood from the left ventricle into the aorta.

In 14 are three augmentation units ( 71 ), which are located in areas at the upper edge of the envelope ( 7 ) are located. Each of the augmentation units ( 71 ) is in this example by a separate line ( 41 ) provided. In the case of augmentation units ( 71 ) in the form of inflatable chambers are the lines ( 41 ) preferably pneumatic or hydraulic lines. Other embodiments comprise one, two, three, four, five, six or more augmentation units ( 71 ) with one, two, three, four, five, six or more lines ( 41 ) are supplied. The at least one line ( 41 ) can be made of plastic, polymer, rubber rubber, latex, silicone or polyurethane. The at least one line ( 41 ) may be above, next to or below at least one augmentation unit ( 71 ). The at least one line ( 41 ) may preferably be placed under a positioning unit ( 72 ), so that no pressure points between the at least one line ( 41 ) and the heart wall. The at least one line ( 41 ) can also be placed above or next to a positioning unit ( 72 ).

In the 14 illustrated augmentation units ( 71 ) A1, A2, and A3 are located at an area at the upper edge of the envelope ( 7 ) and are each by a separate line ( 41 ) provided. The augmentation units ( 71 A1 and A2 may be positioned, as in this embodiment, to support a left ventricle. The augmentation unit ( 71 ) A3 is positioned to support a right ventricle. The individual augmentation units ( 71 ) A1, A2 and A3 can be individually expanded. The augmentation units ( 71 ) A1 and A2 may be used to support left heart failure. The augmentation unit ( 71 ) A3 can be used to support right heart failure. The augmentation units ( 71 ) A1, A2 and A3 can be used to support bilateral heart failure. The augmentation units ( 71 ) can be expanded synchronously or asynchronously. Preferably, the expansion of the augmentation units ( 71 ) are coordinated so that a natural pumping function of the heart is supported.

A positioning unit ( 72 ) is a unit that can also be expanded. Preferably, a positioning unit is more statically expanded than periodically during operation of the device to support the function of a heart. The positioning unit ( 72 ) can be expanded to fix the device to the heart and to optimize the fit of the device. With the help of a positioning unit ( 72 ) can also be responsive to changes in the heart muscle. If the heart muscle breaks down or on, a positioning unit ( 72 ) can be further expanded or relaxed to ensure a perfect fit.

In 14 is a positioning unit ( 72 ) representing the spaces between the three augmentation units ( 71 ) on the shell ( 7 ) substantially. The positioning unit ( 72 ) may consist of one or more augmentation units ( 71 ) have a lateral spacing of 1 mm, 3 mm, 5 mm, 10 mm, 20 mm, 30 mm, 40 mm or more. The positioning unit ( 72 ) can with its own line ( 41 ), in the case of a fluid-fillable chamber with its own pneumatic or hydraulic line, are supplied. Other embodiments comprise one, two, three, four, five, six or more positioning units ( 72 ) with one, two, three, four, five, six or more pneumatic or hydraulic lines ( 41 ) are supplied. The administration ( 41 ) can be made of plastic, polymer, rubber rubber, latex, silicone or polyurethane. The at least one line ( 41 ) for supplying the positioning unit ( 72 ) can be placed under the positioning unit ( 72 ). In the 14 illustrated a positioning unit ( 72 ) fills areas between the augmentation units ( 71 ) out. The illustrated Positioning unit ( 72 ) has appendages extending into the spaces between the augmentation units ( 71 ) protrude.

15 shows an expandable unit ( 71 . 72 ) in the form of a chamber ( 710 ). The illustrated chamber is a bellows-shaped chamber ( 710 ). A bellows-shaped chamber ( 710 ) has at least one section which is in the form of a bellows. Preferably, it is a bellows consisting of one, two, three, four, five, six, seven or more folds. As a fold, an outwardly directed crease edge ( 711 ) To be defined. As a fold, an inwardly directed crease edge ( 712 ) To be defined. One, several or all creases ( 711 . 712 ) can be strengthened. A reinforcement of a bending edge ( 711 . 712 ) is advantageous because the bending edge ( 711 . 712 ) by expanding and relaxing the chamber ( 710 ) may be exposed to increased loads. A reinforcement of one or more creases ( 711 . 712 ) material fatigue along the at least one bending edge ( 711 . 712 ) reduce or prevent. A reinforcement of a bending edge ( 711 . 712 ) can by a higher wall thickness of the material at the bending edge ( 711 . 712 ) can be achieved. A reinforcement of a bending edge ( 711 . 712 ) may also be accomplished by applying additional material, wherein the deposited material may be the same material as the underlying material, or wherein the deposited material may be other than the underlying material. A chamber ( 710 ), an upper side ( 713 ), have a bottom and a side surface, wherein the side surface is preferably formed bellows-shaped. The upper ( 713 ) and / or the bottom may be oval, circular, elliptical or polygonal. The top ( 713 ) may have a different shape than the bottom.

A bellows-shaped chamber ( 710 ) can be introduced into a dish as described above. The chamber ( 710 ) can be fixed or fixed directly in the shell. The chamber ( 710 ) can be attached to structural elements of the shell, such as a wire of a wire mesh, a strut of a latticework, or a structure on a shell shell. The chamber ( 710 ) can be attached to crossing points of a mesh or latticework. The shell may be covered with a membrane as described above. In these cases, the chamber ( 710 ) are also attached to the membrane. The membrane can also be a bottom of the chamber ( 710 ) be.

The bellows-shaped chamber ( 710 ) can also be applied to a case ( 7 ) be attached. Several bellows-shaped chambers ( 710 ) can be placed on a sleeve ( 7 ) be attached. The case ( 7 ) may at least partly have the shape of a heart. The case ( 7 ) may have a similar shape to the shell. The case ( 7 ) can be introduced into the shell. The case ( 7 ) can be fixed in the shell and / or fixed. The case ( 7 ) in addition to one or more augmentation units, such as one or more bellows-shaped chambers ( 710 ), also have one or more positioning units. The underside of the chamber ( 710 ) can be made of the same material as the shell ( 7 ). The case ( 7 ) can be part of the chamber ( 710 ) be. The case ( 7 ) can form the bottom of the chamber. In such cases, on a shell ( 7 ) applied only the side surfaces that may be bellows. In addition, an upper side ( 713 ). The top ( 713 ) can also be a shell. Embodiments consist of two shells ( 7 ), whereby the envelopes ( 7 ) form the top and bottom of the chambers and side surfaces are formed between the envelopes. Side surfaces can be formed in this case by bonding, in particular by welding or gluing, the two shells. The covers ( 7 ) can be connected to each other, in particular welded or glued, that a chamber is formed. The at least one line which supplies the chamber can, similar to the chamber, at least partly also by connecting the two sheaths ( 7 ), in particular by welding or gluing the two sheaths ( 7 ) are formed. On one of the two covers ( 7 ) or on both cases ( 7 ) may be one or more sensors or one or more electrodes.

The case ( 7 ) with the at least one expandable unit may have at least one pocket at the upper edge and / or at the lower edge. The at least one pocket can be at least partially slipped over a structural shape of a shell. The bag can be at least partially slipped over a loop of a wire mesh or a bracket of a lattice, for example.

The case ( 7 ) with the at least one expandable unit may contain an active ingredient. For example, the envelope ( 7 ) an antithrombotic drug, an anti-proliferative drug, an anti-inflammatory drug, an anti-neoplastic drug, an anti-mitotic drug, an anti-microbial drug, a biofilm synthesis inhibitor, an antibiotic drug, an antibody, an anticoagulant Active ingredient, a cholesterol-lowering agent, a beta-blocker, or a combination thereof. Preferably, the active ingredient is in the form of a coating on the shell ( 7 ). The case ( 7 ) may also be coated with extracellular matrix proteins, in particular fibronectin or collagen.

16 shows a shell ( 80 ) with at least one sensor ( 81 ) and / or at least one electrode ( 82 ). The 3D shape of the shell ( 80 ) in 16a is similar to the one in 13a explained 3D Model and shows a coordinate system as described above. The case ( 80 ) can at least partially enclose a heart. The case ( 80 ) may at least partly have the shape of a heart. The case ( 80 ) may have a similar shape to the shell. The case ( 80 ) can be introduced into the shell. The case ( 80 ) can be made of plastic, polymer, rubber rubber, latex, silicone or polyurethane. The case ( 80 ) may have a thickness of 0.1 mm to 1 mm, preferably 0.2 mm to 0.5 mm. The case ( 80 ) with the at least one sensor ( 81 ) and / or at least one electrode ( 82 ) can be pressed against the heart muscle through the shell with the expandable units. The case ( 80 ) may be coated, in particular with a lubricant which reduces the friction between the heart muscle and the sheath ( 80 ) with the at least one sensor ( 81 ) and / or the at least one electrode ( 82 ) decreased. A coating, in particular a coating with a lubricant, can also be applied between the envelope ( 80 ) with the at least one sensor ( 81 ) and / or the at least one electrode ( 82 ) and the shell with the at least one expandable unit. The at least one sensor ( 81 ) and / or the at least one electrode ( 82 ) can be placed in the shell ( 80 ), cast in or welded in, or on the envelope ( 80 ), glued or sewn on. The at least one sensor ( 81 ) and / or the at least one electrode ( 82 ) can be provided with reinforcements that can prevent buckling during compression of the device.

In 16a is the shell ( 80 ) with at least one sensor ( 81 ) and / or at least one electrode ( 82 ) as a shell ( 80 ) with a plurality of sensors ( 81 ) and electrodes ( 82 ). 16b shows a 2D unroll of the 3D model 16a , In the 16b shown unwinding corresponds essentially to in connection with 13b Explained unrolling of a 3D model. Unlike in 13a is the 3d model in 16a rotated so that a view from above into the shell ( 80 ). In the 16a and 16b are exemplary eight sensors ( 81 ) or electrodes ( 82 ). Other embodiments may include one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve or more sensors ( 81 ) and / or electrodes ( 82 ). The case ( 80 ) with at least one sensor ( 81 ) or at least one electrode ( 82 ) can be a network of sensors ( 81 ) or electrodes ( 82 ) be. The network of sensors ( 81 ) or electrodes ( 82 ) may at least partially surround the heart. The sensors ( 81 ) or electrodes ( 82 ) in the network of sensors ( 81 ) or electrodes ( 82 ) can be connected to each other. The case ( 80 ) can be used as a carrier for the network of sensors ( 81 ) or electrodes ( 82 ) act. The network of sensors ( 81 ) or electrodes ( 82 ) can only partially on a shell ( 80 ) to be appropriate. The network of sensors ( 81 ) or electrodes ( 82 ) can also be used without a shell ( 80 ) are introduced into a dish as described above.

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

The at least one electrode ( 82 ) may be suitable for stimulating areas of the heart and / or measuring the action potential on the myocardium during the excitation process. In particular, the at least one electrode ( 82 ) be able to stimulate the heart muscle by means of electrical impulses. Electrical stimulation can stimulate a heart muscle to contract. The at least one electrode ( 82 ) may be a pacemaker electrode. The electrode ( 82 ) may be an extracardiac stimulation electrode. The heart muscle can with an electrode ( 82 ) are stimulated by a shell having at least one expandable moiety before, during, or after a promotion of the pumping function of the heart. The expansion of an expandable unit may take place before, during or after stimulation with an electrode ( 82 ) expire. The device for supporting the function of a heart can only be used with at least one expandable unit or only by stimulation with at least one electrode ( 82 ) operate. Simultaneous operation of the at least one expandable unit and the at least one electrode ( 82 ) can be synchronous or asynchronous. The at least one electrode can also be used as a sensor.

The at least one sensor ( 81 ) or the at least one electrode ( 82 ) can on the shell ( 80 ) be attached. The at least one sensor ( 81 ) or the at least one electrode ( 82 ) can on the shell ( 80 ) glued, sewn or welded. The at least one sensor ( 81 ) or the at least one electrode ( 82 ) can in the shell ( 80 ), preferably welded. The at least one sensor ( 81 ) or the at least one electrode ( 82 ) can via a line ( 84 ) be connected to a supply unit. The from the sensor ( 81 ) or the Electrode ( 82 ) can also be transmitted connectionless via a wireless technology such as bluetooth.

The contacts of the electrodes or sensors or the entire envelope can be coated with a substance that increases or improves the conductivity. For example, a graphite coating on the contacts can increase their conductivity.

example 1

17 shows an embodiment of a shell ( 7 ) with at least one expandable unit ( 71 . 72 ). Shown in 17 is one related to 13 described 2D unrolling a 3D model. The illustrated sheath of this embodiment comprises three augmentation units ( 71 ) (A1, A2, A3) and a positioning unit ( 72 ) (P). In this embodiment, the augmentation units A1 and A2 each occupy an area of 28.6 cm ² on the shell. The area occupied by the augmentation unit A3 is 34.5 cm ² in this example. In this embodiment, the positioning unit ( 72 ) (P) has an area of 114.5 cm ² . Under normal conditions, the nominal expansion of the positioning unit (P) is 5 mm, ie the positioning unit is partially expanded and has a thickness of 5 mm. The positioning unit may be a chamber that can be filled with a fluid and deflated. The thickness of the positioning unit can thereby be between 1 mm and 10 mm, preferably between 3 mm and 7 mm. By changing the thickness of the positioning unit ( 72 ) (P) can be compensated for an increase or decrease in the size of the heart and the correct fit of the envelope ( 7 ) and / or shell is essentially guaranteed. The augmentation units A1 and A2 can be expanded in their thicknesses about 1.9 cm in this example to build up a pressure on a ventricle, here a left ventricle. The effective volume expansion of the augmentation units A1 and A2 is 40 ml in this example. The effective volume expansion of the augmentation unit A3 in this case is 50 ml and results in an effective thickness expansion of 1.45 cm. Each of the corners of an augmentation unit can be defined by the coordinates of the vertices. The coordinate system was related to 13 explained.

In the present example, the augmentation unit A1 runs from vertex 1 (φ = 359 °, z = 100) via vertex 2 (φ = 48 °, z = 85) and vertex 3 (φ = 48 °, z = 40) to vertex 4 (FIG. φ = 328 °, z = 56) and is in the implanted state on the left ventricle. The connection of the corner 1 with corner 2 is substantially parallel to the upper edge of the shell ( 7 ) with a distance (d) of about 5 mm. The junction of vertex 2 with vertex 3 extends substantially along the φ = 48 ° line. The connection of the vertex 3 with vertex 4 is substantially parallel to the upper edge of the shell shown in the 3D model ( 7 ). The connection of the corner point 4 with the corner point 1 runs essentially along the septum line (FIG. 616 ). The corners of the augmentation unit A1 are rounded and describe a circular arc with a diameter of 4 mm.

The augmentation unit A2 in the present example runs from vertex 1 (φ = 116 °, z = 69) via vertex 2 (φ = 182 °, z = 74) and vertex 3 (φ = 212 °, z = 37) to vertex 4 (FIG. φ = 116 °, z = 26) and abuts the left ventricle when implanted. The connection of the corner 1 with corner 2 is substantially parallel to the upper edge of the shell ( 7 ) with a distance (d) of about 5 mm. The connection of the corner point 2 with the corner point 3 runs essentially along the septum line (FIG. 616 ). The connection of the vertex 3 with vertex 4 is substantially parallel to the upper edge of the shell shown in the 3D model ( 7 ). The connection of the corner point 4 with the corner point 1 extends substantially along the φ = 116 ° line. The corners of the augmentation unit A2 are rounded and describe a circular arc with a diameter of 4 mm.

In the present example, the augmentation unit A3 runs from vertex 1 (φ = 235 °, z = 92) via vertex 2 (φ = 303 °, z = 108) and vertex 3 (φ = 303 °, z = 64) to vertex 4 (FIG. φ = 235 °, z = 48) and is in the implanted state on the right ventricle. The connection of the corner 1 with corner 2 is substantially parallel to the upper edge of the shell ( 7 ) with a distance (d) of about 5 mm. The connection of the vertex 2 with the vertex 3 extends substantially along the φ = 303 ° line. The connection of the vertex 3 with vertex 4 is substantially parallel to the upper edge of the shell shown in the 3D model ( 7 ). The connection of the vertex 4 with the vertex 1 extends substantially along the φ = 235 ° line. The corners of the augmentation unit A3 are rounded and describe a circular arc with a diameter of 4 mm.

The positioning unit P in the embodiment of 17 is designed such that it separates the spaces between the augmentation units ( 71 ) on the shell ( 7 ) substantially. The positioning unit ( 72 ) can also be described as a positioning unit ( 72 ) with appendages which contain the areas on the envelope (not filled in by the augmentation units) 7 ) substantially. In the exemplary embodiment, the positioning unit P essentially has one lateral distance (d) from the augmentation units ( 71 ) and the upper edge of the envelope ( 7 ) of about 5 mm. Also, the positioning unit ( 72 ) from the cutting line ( 615 ), which may be advantageous in the manufacture. Will the envelope ( 7 ) are formed with the at least one expandable unit in a two-dimensional state, all augmentation units ( 71 ) and positioning units ( 72 ) on the shell ( 7 ) before the envelope ( 7 ) is rolled into a three-dimensional shape.

The pipes ( 41 ) containing the expandable units ( 71 . 72 ) are in the embodiment of 17 hydraulic or pneumatic lines ( 41 ) extending radially from the lower edge of the shell to the augmentation units. The administration ( 41 ) for the augmentation unit A1 runs along the line φ = 15 ° and ends at a height of z = 54. The line ( 41 ) for the augmentation unit A2 runs along the line φ = 165 ° and ends at a height of z = 31. The line ( 41 ) for the augmentation unit A3 runs along the line φ = 270 ° and ends at a height of z = 65. 41 ) for the positioning unit P runs along the line φ = 330 ° and ends at a height of z = 25.

Example 2

18 shows an embodiment of a shell ( 80 ) with at least one sensor ( 81 ) and / or an electrode ( 82 ). Shown in 18 is one related to 13 described unrolling a 3D model. The illustrated case ( 80 ) this embodiment comprises eight sensors ( 81 ) or electrodes ( 82 four of which are pressure sensors (FS1, FS2, FS3, FS4) ( 81 ) and four electrocardiogram electrodes (ECG, electrocardiogram electrode ECG1, ECG2, ECG3, ECG4) ( 82 ) are. The case ( 80 ) can be made of plastic, polymer, rubber rubber, latex, silicone or polyurethane. The case ( 80 ) may have a thickness of 0.1 mm to 1 mm, preferably 0.2 mm to 0.5 mm. The four pressure sensors ( 81 ) can be placed in the envelope ( 80 ), in particular cast or welded. The pressure sensors ( 81 ) can be provided with reinforcements that can prevent buckling during compression of the device. The ECG electrodes ( 82 ) can on the heart-facing side of the shell ( 80 ) to be appropriate. In the embodiment in 18 is a coordinate system as related to 13 described described. With the help of the coordinate system, the positions of the sensors ( 81 ) and electrodes ( 82 For this embodiment, the pressure sensor FS1 is located at the coordinate (φ = 17 °, z = 71), the pressure sensor FS2 is at the coordinate (φ = 158 °, z = 48), the pressure sensor FS3 is located at the coordinate (φ = 268 °, z = 78), the pressure sensor FS4 is located at the coordinate (φ = 67 °, z = 61). The ECG electrode ECG1 is located at the coordinate (φ = 76 °, z = 54), the ECG electrode ECG2 is located at the coordinate (φ = 352 °, z = 39), the ECG electrode ECG3 is on the coordinate (φ = 312 °, z = 93) and the ECG electrode ECG4 is at the coordinate (φ = 187 °, z = 18). For smaller or larger hearts, the angular coordinates for the sensors ( 81 ) and / or electrodes ( 82 ) is essentially the same, the z-value is to scale by one factor for smaller and larger hearts, respectively. For smaller hearts, a scaling factor can range from 0.85 to 0.95, and for large hearts, a scaling factor can range from 1.05 to 1.15.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 5749839 B1 [0006]
• US 6626821 B1 [0006]
• WO 00/25842 [0006]

Claims (47)

 A device for supporting the function of a heart comprising a closure for sealing a membrane breakthrough, the closure comprising: a first closure element with a first sealing lip, a second closure element with a second sealing lip.  The device of claim 1, wherein the closure has a central lumen.  Device according to one of the preceding claims, wherein the first closure element can be coupled to the second closure element.  Device according to one of the preceding claims, wherein the first closure element can be secured to the second closure element with a mechanism.  A closure according to claim 4, wherein the mechanism comprises a screw mechanism and / or a thread.  The device of claim 4, wherein the mechanism comprises a clamping mechanism.  The device of claim 4, wherein the mechanism comprises a bayonet lock.  Device according to one of the preceding claims, wherein the first closure element and / or the second closure element are compressible with or without their sealing lips or wherein at least one of the sealing lips can be applied to one of the closure elements.  Device according to one of the preceding claims, wherein the first closure element and / or the second closure element are expandable with or without their sealing lips, preferably, wherein the first closure element and / or the second closure element are self-expandable with or without their sealing lips.  Apparatus according to any one of the preceding claims, wherein each of the closure members or their sealing lips has a first configuration and a second configuration.  The apparatus of claim 10, wherein the first configuration is a compressed configuration and the second configuration is an expanded configuration.  The apparatus of claim 11, wherein the apparatus further comprises a delivery system.  Apparatus according to claim 12, wherein the delivery system can be coupled to the first closure element, in particular wherein the delivery system can be plugged onto a cone located on the first closure element.  Apparatus according to claim 13, wherein the first closure element and the second closure element can be introduced into a body with the delivery system.  Device according to claim 14, wherein the first closure element or the sealing lip of the first closure element and the second closure element or the sealing lip of the second closure element expand after being introduced with the feed system.  Device according to one of the preceding claims, wherein the first and / or second closure element made of metal or plastic.  Device according to one of the preceding claims, wherein the first and / or second closure element at least partially of polyamide (PA), polyurethane (PUR), polyetheretherketone (PEEK), polyethylene (PE), polypropylene (PP), polycarbonate (PC), polyethylene terephthalate (PET) exists.  Apparatus according to claim 17, wherein both closure elements are made of the same material or wherein each of the closure elements is made of a different material.  Device according to one of the preceding claims, wherein the first and / or second sealing lip is disc-shaped.  Device according to one of the preceding claims, wherein the first and / or second sealing lip is concave.  Device according to one of the preceding claims, wherein the material for the first and / or second sealing lip is elastic.  Device according to one of the preceding claims, wherein the material for the first and / or second sealing lip plastic, rubber, rubber, silicone or latex comprises.  Device according to one of the preceding claims, wherein the closure has a central lumen and the first and / or second sealing lip having an increased flexibility with increasing radial distance from the central lumen. Apparatus according to claim 23, wherein the increased flexibility is achieved by an elastic material, by a variable thickness of the sealing lip, by material changes within the sealing lip, or by stiffening in or on the sealing lip.  Apparatus according to claim 24, wherein the stiffeners of the sealing lip are caused by applying or introducing material, in particular wherein concentric rings or radial struts of another material in the sealing lip lead to stiffeners.  Device according to one of the preceding claims further comprising engaging elements on the first and / or second closure element.  Apparatus according to claim 26, wherein the engagement elements are holes, indentations or elevations by means of which the closure element can be gripped.  The apparatus of claim 27, wherein 2, 3, 4, 5, 6, or more holes, indentations or protrusions are mounted on the closure member.  Apparatus according to claim 28, wherein the holes, indentations or protrusions are equidistant from each other.  Tool for gripping at least one of the closure elements according to one of the preceding claims.  A tool according to claim 30, wherein the tool has elements engageable with the engaging elements of claims 19 to 22.  A tool according to claim 30 or 31, wherein the tool comprises an elongated tubular portion.  A tool according to claim 32, wherein the elongate tubular portion has a round, oval or angular cross-section.  The tool of claims 30 to 33, wherein the tool has a handle.  The tool of claim 34, wherein the tool has an elongate tubular portion and the handle projects laterally from the elongate tubular portion, in particular, the handle being mounted transversely of the elongate tubular portion.  Tool according to claim 30 to 35, wherein the tool has a predetermined breaking point at which the tool can be divided in two halves lengthwise.  Device according to one of the preceding claims, wherein the closure is designed to close a membrane, a tissue layer, or an organ wall.  A device according to any one of the preceding claims, wherein the closure is adapted to seal an opening in the pericardium, in particular wherein the closure is adapted to seal an opening in the pericardium proximate the apex of the heart.  Device according to one of the preceding claims, wherein the device further comprises a cable which can be guided through the central lumen of the closure elements.  Device according to claim 39, wherein the first closure element comprises a seal on the lumen side, which seals the cable against the closure element.  The device of any one of the preceding claims, wherein the device further comprises a shell that can at least partially enclose a heart.  The apparatus for supporting the function of a heart according to claim 41, further comprising: at least one shell that can be inserted into the shell.  The apparatus for supporting the function of a heart according to claim 42, wherein the at least one sheath comprises at least one expandable unit, in particular wherein the expandable unit is a chamber.  The device for supporting the function of a heart according to claim 42, wherein the at least one sheath comprises at least one sensor.  A device for supporting the function of a heart according to one of claims 43 or 44, further comprising a supply unit.  The apparatus for supporting the function of a heart according to claim 47, further comprising a cable for connecting the at least one expandable unit or the at least one sensor to the supply unit.  The device of claim 46, further comprising a plug for connecting the device to assist in the function of a heart with a supply unit.

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