Container for a heart pump device and method for operating a heart pump device

Abstract

The invention relates to a container (1, 1', 1") for a heart pump device (4, 8, 12, 17, 18, 19, 26), comprising a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on multiple sides, in particular on all sides, by one or more closing elements (5, 5', 6, 6', 6") and is closed to the outside to prevent contact with the heart pump, wherein the closing elements (5, 5', 6, 6', 6") leave an opening (7) for a catheter (8) to pass from the outside into the first receiving space (3), wherein the diameter of the opening (7) is dimensioned such that the heart pump can only be passed under a condition that is at least partially compressed compared to the expanded condition. For implantation, the heart pump can first be tested in the container (1, 1', 1") while flushing liquid is provided and can then be drawn into a locking element (11) through the opening (7) while being compressed.

Description

[0001] This application is a divisional application of the invention patent application "Container for a heart pump device and method for operating a heart pump device" with application number 201680009047.1 filed on August 4, 2017. Technical Field

[0002] The invention belongs to the field of mechanics and engineering, namely precision engineering, and can be advantageously applied in the field of medical technology. In particular, the invention relates to an advantageous packaging for a heart pump device. Background Art

[0003] In recent years, mechanical heart pumps have been increasingly used to assist or replace the activity of a patient's heart. Basically, such pumps are operated inside or outside the patient's body. However, in many cases, it is desirable to implant such pumps inside the patient's body.

[0004] In this case, pumps that can be compressed and expanded to a great extent, so that they can be implanted in small dimensions and then expanded in the patient's body, are already known. A special type of such pumps comprises a drivable rotor for conveying blood in an axial direction, wherein the rotor with the pump housing can preferably be introduced into the region of the ventricles or the aorta and operated therein. Such a pump can be introduced into the patient's body, for example, by means of blood vessels to the heart.

[0005] Reliable sterility is, of course, essential for the manufacture, transport and preparation for implantation of such heart pump systems. Certain components of the heart pump device can be dangerous if they are not removed professionally and carefully from their sterile packaging. In particular, implanted components must be protected from contact with objects outside the patient's body. For example, contamination of the villi can also seriously impair the function of such a pump, and in some cases, improper contact by hand can cause serious damage. Summary of the invention

[0006] Against this background, the object of the present invention is to provide a container for a heart pump device which reliably protects the components of the heart pump device, keeps them sterile and allows a reduced risk of contamination during removal.

[0007] According to the present invention, this object is achieved by the technical features of the present invention. In the embodiments of the present invention, a design is specified.

[0008] Therefore, aspects of the present invention relate in particular to a container for a heart pump device having a first receiving space for a compressible and expandable heart pump, wherein the first receiving space is delimited on multiple sides, in particular on all sides, by one or more closing elements and is isolated from the outside to prevent the heart pump from being contacted, wherein the closing elements leave an opening for allowing a catheter to pass from the outside to the first receiving space, wherein the diameter of the opening is sized such that the heart pump can completely pass through the device under a condition that is at least partially compressed compared to an expanded condition.

[0009] Therefore, the heart pump device includes at least one compressible and expandable heart pump, and other components as appropriate, such as a catheter and / or a catheter flushing device, and a drive shaft for the heart pump running within the catheter, and other components as appropriate.

[0010] A container should be provided for such a heart pump device. The container comprises a first receiving space in which the heart pump can be accommodated so that it is protected from contact by the closing element, for example from contact by an operator. In this way, the closing element can close the closed space in a fluid-tight manner, leaving only the opening for the passage of the catheter. However, it is also conceivable for the closing element to include an opening and for one of the closing elements to be configured, for example, in a grid-like form. For example, in this way, optical control of the heart pump in the first receiving space can be made possible. However, at least a portion of at least some of the closing elements can be designed to be light-transmissive to allow observation of the interior of the first receiving space.

[0011] The opening of the catheter channel is used to guide the catheter directly connected to the heart pump through, wherein advantageously, the entire length of the catheter is left outside the first receiving space in the second receiving space of the container. Finally, a handle provided on the catheter for manipulation can have room in the third receiving space of the container and can be surrounded there, for example, similarly on all sides by the wall of the container.

[0012] The size of the opening diameter should be such that the pump cannot be removed through the opening in the expanded state (the opening can be larger when packed and then closed with the cover). For example, it is conceivable that the pump in the expanded state is installed in the first receiving space so that it can be operated therein for testing. The rotor of the pump can be rotated, for example, driven by a drive shaft passing through a catheter, in order to test whether the heart pump is ready for operation. The limited size of the opening ensures that the heart pump in this expanded state cannot be simply removed from the first receiving space, for example pulled out by the catheter. Decisive here is the fact that the pump or the pump head cannot be touched by hand. The risk of inadvertent contact with the heart pump is further reduced. Due to the size of the opening, it is ensured that the heart pump should be at least partially compressed when it is removed from the first receiving space, so that the heart pump can be directly dragged into a sheath applied outside the opening area of ​​the first receiving space, the sheath at least accommodating the pump in a partially compressed state. It is conceivable that the diameter of the opening is less than 6 mm, preferably less than 5 mm, in particular less than 4 mm.

[0013] According to an advantageous design of the container according to the invention, at least the closing element, in particular the complete container, is conceived to consist essentially of a plastic material, in particular a plastic foil. The container can be manufactured, for example, as a so-called blister of a flexurally rigid plastic foil. However, a thicker plastic material can be provided, or a part of the container can consist of a plastic element manufactured by an injection molding process. If the container consists essentially of a blister, it can be formed from the plastic foil by deep drawing or pressing.

[0014] A further beneficial design concept of the present invention is that the first receiving space is mainly defined by two half-shell-shaped closing elements joined together. For example, the receiving space can include a groove-shaped first half-shell for accommodating the heart pump, the groove portion divides the first receiving space, and at least one half-shell-shaped closing element can be placed on the first half-shell to completely close the first receiving space. The second half-shell that forms the cover body in this way can be joined to the first half-shell by pressing, bonding, welding or any other joining method, and can advantageously not be disassembled unless it is destroyed. In this way, it can be ensured that the heart pump remains in the first receiving space from the time it is set in the receiving space at the manufacturer until before implantation, and cannot be removed between these two time points.

[0015] The invention thus contemplates that the closure elements engage with one another in a non-releasable or difficult to releasable manner.

[0016] The two half-shells can be placed opposite each other with the openings facing each other or with a corresponding alignment of the openings.

[0017] Furthermore, it is advantageously conceivable that the opening is formed so as to allow the catheter to pass between the two closing elements, or the opening is directed toward the joint between the two closing elements. In this way, the heart pump and the catheter connected thereto can be inserted into the opening in a relatively simple manner before the plurality of closing elements are joined together to divide the first receiving space.

[0018] As already mentioned above, an advantageous concept could be that a first one of the closure elements is designed as a part of a blister for receiving at least one catheter and, in particular, additionally, further parts of the heart pump device.

[0019] It is also conceivable that the first closing element forms a receiving shell for the fluid in the region of the first receiving space. This simplifies the wetting of the heart pump with liquid in the first receiving space for testing. In addition, the wetting is beneficial for lossless compression of the pump. For example, the fluid can be supplied to the heart pump via a catheter. The receiving shell ensures, on the one hand, that the fluid gathers around the pump to ensure wetting of the heart pump and, on the other hand, that the fluid does not escape from the first receiving space in an uncontrolled manner.

[0020] The invention can also be provided with an opening consisting at least partially of a cylindrical symmetrical channel. This cylindrical symmetrical channel, which preferably has smooth walls, allows the heart pump to be compressed while passing through it without damaging the housing of the heart pump. Thus, a preferred concept can be that the cylindrical symmetrical channel narrows from the inside of the first receiving space to the outside and has no sharp edges in the area where the pump passes.

[0021] The cylindrical symmetrical channel for this purpose can be designed, for example, in the form of a cone or a sectionwise cone. For example, the run-out leading to the interior of the first receiving space can include an introduction funnel, into which the heart pump can be drawn and at least partially compressed.

[0022] Furthermore, it may also be advantageous if the projection to the outside of the closing element and to the first receiving space comprises an edge on which a hollow cylindrical sheath element is arranged which is movable along the duct and can be supported in the axial direction of the channel.

[0023] A sheath in the form of a hollow cylindrical part, in particular a peel-off sheath which can be destructively removed radially, for example by tearing off the opening, can be put over a catheter, i.e. the catheter can be dragged into the sheath, and is usually already part of a heart pump device located in a container. Such a sheath element can be pressed against the edge of the opening on the closing element from the outside of the first receiving space, so that the heart pump can be dragged from the first receiving space into the sheath element through the opening using a catheter passing through the sheath element. As a result, the heart pump is at least partially radially compressed in the opening of the receiving space and is further radially compressed in particular when entering the sheath element. However, it is also conceivable that the inner diameter of the sheath element corresponds to the diameter of the heart pump that has been compressed in the opening of the receiving space, so that further compression when dragged into the sheath can be reduced. The edge of the opening can advantageously be an annular surface extending in a direction perpendicular to the longitudinal axis of the opening.

[0024] When the heart pump has been pulled into the sheath element, the heart pump device can be removed from the container and introduced into the patient via the introduction sheath. To this end, the sheath element is sleeved onto the introduction sheath and the heart pump is removed from the sheath element into the introduction sheath. If the sheath element is designed as a peel-off sheath, the sheath element can be removed without any problems after the heart pump has been introduced into the introduction sheath. However, the sheath element itself can serve as an introduction sheath in that the pump is compressed in the sheath element and then introduced into the patient, for example via a traction line. For this purpose, a separate lumen is provided for the traction line.

[0025] In addition to the above-mentioned type of container, the present invention also relates to a container with a heart pump device in a corresponding embodiment, wherein a compressible and expandable heart pump is located in a first receiving space, and wherein a catheter connected to the heart pump extends outward from the first receiving space through an opening, wherein in particular a sheath element through which the catheter passes is arranged on the catheter in a freely movable manner.

[0026] The invention also relates to a method for operating a heart pump device, with which the heart pump is arranged in a first receiving space of a container according to the invention and is driven in rotation, for example, by an external shaft passing through a catheter to the heart pump (however, pumps with an electric motor integrated in the pump head are also possible). The method allows the functional capacity of the heart pump with the rotor to be tested in advance in the container without direct contact and the risk of post-sterilization contamination. The speed of the test operation is usually lower than the operating speed in the patient, for example at 50%, in particular only 30%, or even at least 10%.

[0027] For this purpose, it can also be advantageously conceived that the fluid is conveyed to the heart pump along the catheter through an opening provided on the catheter. In this way, it can be ensured that the heart pump is tested in contact with the fluid under real conditions. The heart pump device can also be filled with liquid as much as possible, thereby greatly avoiding the introduction of air during implantation. Any biocompatible flushing liquid, such as saline solution, glucose solution or the like, can be considered as the liquid conveyed to the heart pump.

[0028] The invention also relates to a method for operating a heart pump device, with which a heart pump is arranged in a first receiving space of a container according to the invention, wherein the heart pump is connected to a catheter, which protrudes out of the first receiving space through an opening, characterized in that the heart pump is pulled out of the first receiving space through the opening through the catheter in a radially compressed state and drawn into a sheath element, which can be freely moved on the catheter in the axial direction, i.e. in the longitudinal direction of the catheter.

[0029] The object specified in the present invention includes in particular one or more closing elements which delimit a receiving space for a compressible and expandable heart pump. A "receiving space" is preferably understood to be the smallest complete space which completely surrounds the pump head of the heart pump (e.g. connected to the removal opening 7 (see Figures 1 to 3 ) is not included in this. This is to prevent contact with the heart pump, that is, to protect the heart pump from being touched in the receiving space. The closing element leaves at least one free opening for the catheter to pass through, wherein the size of the opening diameter is such that the heart pump can only pass through in a state at least partially compressed compared to the expanded state. Therefore, "letting the catheter pass through" should be understood as letting the corresponding catheter pass through the opening, and it is best not to be understood as a certain passing direction. In the present invention, "one or more closing elements" are mentioned. In particular, in the case of "multiple closing elements", these closing elements can have different designs. This means that the closing elements forming the receiving space can be connected to each other in different ways. Therefore, the connection can be achieved, for example, by threaded connection, etc. This connection is preferably such that it cannot be loosened without destruction, but it can also be manufactured in an alternative way to avoid destruction. Thus, the expanded pump can be accommodated in the receiving space in a way that these closing elements "surround the pump" and are connected together, and can no longer be separated from each other in an undamaged way. In this case, the joining line connecting the different closing elements to each other can be arranged outside the opening of the receiving space along the longitudinal direction of the catheter, or it can be perpendicular to this direction. The specific details of this point are described in detail below.

[0030] In one embodiment, the first receiving space is delimited by at least two closure elements connected along a joining line, wherein the cross section of the joining line extending in the receiving space is larger than the cross section of the opening for the passage of the catheter. In this way, the closure elements can be joined "around the pump head", and then extraction of the heart pump (pump head) is only possible in the compressed state.

[0031] A further embodiment envisages a receiving space comprising more than one opening. For this purpose, for example, a compressible and expandable heart pump can be drawn into the receiving space substantially without being compressed. However, the pump head (preferably arranged at the opposite end of the receiving space) can then only be removed in a compressed state (see, for example, Fig.11a ).

[0032] A further development provides that at least one opening of the receiving space is closed by a cover which is joined to the opening of the receiving space in such a way that it can be removed without destruction or after destruction. Thus, for example, the pump can first be introduced into the receiving space through a larger opening (without forcing the heart pump to compress), as described above. This can then be closed with the cover in such a way that it cannot be released in a way that does not prevent destruction. In this way, it is ensured that the heart pump cannot be removed from the receiving space by the user without being compressed.

[0033] It is also possible to provide a receiving space with an opening so that the heart pump device / heart pump / pump head can be introduced into the receiving space without being compressed, but can only be removed in a state that is at least partially compressed compared to the expanded state. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The present invention is illustrated below by way of example in the accompanying drawings and described below. It is shown that:

[0035] Figure 1 is a schematic cross-sectional view of a container according to the present invention,

[0036] Figure 2 is a cross-sectional view of a heart pump container according to the present invention,

[0037] Figure 3 is another cross-sectional view of the container.

[0038] Figure 4 It's a heart pump with a catheter.

[0039] Figure 5 This is the front view with the heart pump container.

[0040] Figure 6 is a cross-sectional view of a container with a heart pump and with a sheath element,

[0041] Figure 7 is another cross-sectional view through the container and jacket element,

[0042] Figure 8 is a three-dimensional view of the container in the embodiment as a blister,

[0043] Fig. 9 is a cross-section through a container designed as a blister,

[0044] Fig.10 is a three-dimensional view of the details of the container designed as a blister, and

[0045] Fig.11a and 11b is a cross-sectional view or a partial cross-sectional view of a container according to another embodiment of the present invention. DETAILED DESCRIPTION

[0046] Figure 1 The cross-sectional view of FIG. 1 shows a container 1 with two closing elements 5, 6, wherein the first closing element 5 is a solid body and the second closing element 6 is a thin-walled half shell, shaped like a cover, covering the first receiving space 3. The opening 7 is provided in the region of the closing elements 5, 6 and in particular in the first closing element 5 as a recess through which the conduit can protrude from the first receiving space 3 into the external space. A channel 13 extending around one end of the container 1 can be provided, which channel 13 can be used to receive the conduit to allow one or more conduit loops to be arranged. This solid representation of the first closing element 5 is given only as an example to explain its basic function.

[0047] The first closing element 5 should form a fluid-tight receiving basin 14 into which the heart pump can be inserted and which can receive fluid for testing operations.

[0048] The second closure element 6 is preferably non-releasably connected and sealingly connected to the first closure element 5 in the region of a joint 9, wherein the connection can advantageously be designed in a fluid-tight manner, but not in a gas-tight manner (since air should escape from the duct here), except for the opening 7. In this example, the joint 9 forms a joint line, or an annular joint surface that is coplanar overall.

[0049] The second closing element 6 can be designed as a fluid-tight, curved flat plastic part, preferably a rigid foil, but can also comprise an opening and / or one or more optical windows in order to allow viewing of the first receiving space 3. A decisive factor for the second closing element 6 is the ability to protect the heart pump to be held in the first receiving space 3 from being touched.

[0050] like Figure 2 As shown, the first closing element 5' in the container 1' is designed as a blister-shaped hard foil like the second closing element 6'. The first receiving space 3 is shaped as Figure 1In the embodiment of the present invention, the heart pump 4 arranged in the first receiving space 3 is Figure 2 The heart pump 4 comprises a rotor 4a having a helical conveying element 4b and a hub 4c, wherein the hub 4c is connected to a drivable flexible drive shaft 12. The drive shaft 12 extends from the heart pump 4 through a catheter 8 passing through an opening 7.

[0051] The heart pump 4 is shown in a non-compressed state, in which its radial extension is perpendicular to the axial direction indicated by the hub 4 c and is greater than the extension of the opening 7 .

[0052] Already in Figure 2 The portion shown and represented at III in the Figure 3 , a first closing element 5' and a second closing element 6' and an opening 7 are shown in the diagram, into which a catheter 8 with a drive shaft 12 is drawn, and in which the outline of the heart pump 4 is drawn in dashed lines. Figure 3 It can be seen that the diameter of the heart pump 4 is larger than the clear width of the opening 7 , so that the heart pump 4 on the catheter 8 can be pulled out from the opening 7 of the first receiving space 3 only when it is radially compressed.

[0053] Figure 4 shows that there are already Figure 2 A heart pump device with a heart pump 4 described in the drawing, and a catheter 8 with a drive shaft 12, wherein the drive side end of the drive shaft 12 with a magnetic coupler 15 is also shown, which allows the drive movement to be transmitted from the electric motor 16 to the container 17, wherein the drive shaft 12 is connected to the magnetic coupler.

[0054] The container 17 also has a plurality of flushing openings 18, 19, which can function as a flushing device, wherein a flushing fluid, such as a saline solution, is introduced into the container 17 through the opening 18, and excess flushing fluid is removed through the second flushing opening 19. The flushing fluid also moves along the duct 8 in the direction of the pump 4, and in particular moves with the operation of the rotor, i.e. with the rotation of the drive shaft 12, and is conveyed in the direction of the pump 4 through the helical outer profile of the drive shaft 12. Thus, for a test operation, the flushing liquid can be introduced into the first flushing opening 18, moved through the duct 8 towards the pump 4 located in the first receiving space 3, and then the pump can be tested, at least tested at a reduced speed while being wetted by the flushing liquid.

[0055] Figure 5The first closure element 5' and the interior of the first receiving space 3 are shown in a front view, in which the heart pump 4 is arranged. The catheter 8 connected to the heart pump 4 protrudes out of the first receiving space through the opening 7 and is surrounded by a sheath element 11 on the front side of the opening 7 outside the receiving space 3. The sheath element 11 is designed as a flexible plastic protrusion in the form of a hose section, which can have a predetermined breaking point so that it can be pulled out radially at a later stage after the pump 4 is placed in the introduction sheath on the patient's body as a peel-off sheath.

[0056] The sheath element 11 can be put on the edge of the opening 7 on the closing element 5', 6' of the first receiving space 3 from the outside, and the pump 4 can be pulled out of the receiving space 3 through the catheter in the direction of the arrow 20. Since the given diameter of the opening 7 is smaller than the pump diameter in the expanded state, the pump 4 is pulled into the opening 7 in the direction of the arrows 21, 22 in a compressed or at least partially compressed state and is pulled into the sheath element 11 in a radially compressed state. There, the pump is also protected from contact and contamination and can be removed from the container 1' and moved to the introduction sheath on the patient's body.

[0057] Figure 6 The container 1 ′ with the first receiving space 3 is again schematically shown in a side view, in which the pump 4 and the jacket element 11 are arranged, which is arranged in the channel 13 of the container 1 ′ and surrounds the line 8 .

[0058] Figure 7 according to Figure 6 A further perspective in the direction of the center arrow 23 shows an external view of the closing elements 5 ′, 6 ′ with the opening 7 and a front view of the sheath element 11 in the axial direction, and the dotted line indicates the heart pump 4 located in the first receiving space 3 .

[0059] Figure 8 A first closing element 5' designed as part of a blister is shown in a perspective view, which has two recesses, a first recess 24 delimited by the first closing element 5' and forming the lower part of a first receiving space for a heart pump, and a second recess 25 delimiting a third receiving space for a handle on the catheter 8. In addition, the channel 13 can be recognized, which leads from the first recess 24 to the second recess 25, forming a second receiving space and allowing the catheter to be arranged, wherein an additional arched channel 13a is also formed, which allows the catheter loop to be placed. In addition, in the region of the channel 13, there are provided handle recesses 27, 28, which serve on the one hand to stabilize the blister and on the other hand to improve the handling of the handle when the catheter located in the channel 13 is removed, and at the same time to form a protrusion of the blister, so that it can serve as a supporting element when placed on a horizontal surface close to the recesses 24, 25.

[0060] The heart pump 4 and the handle portion 26 are shown inside the container 1' or the closing element 5'. However, usually, the closing element is arranged on the first groove 24 and the second groove 25 so as to cover the corresponding grooves and the components located therein, protect them from contact, and serve as a fixing component to keep them fixed during vibration and complete the container 1". Therefore, the atraumatic tip of the catheter (commonly known as the pigtail tip) is also fixed, so that it does not allow excessive movement of the pump head, but on the other hand, extraction in the direction of the sheath element 11 is not restricted.

[0061] exist Fig. 9 In the embodiment of the invention, a cross section through the groove 24 is illustrated and is formed in a first closure element 5' formed as part of the blister. The projection 29 is formed by a suitable protruding dome of the closure element 5', located in the groove and in the first receiving space, wherein the projection 29 comprises a recess 30 for accommodating the heart pump 4 in the first receiving space 3. This allows the heart pump 4 to be placed accurately, tightly and forcefully in the first receiving space 3. In addition, the first receiving space 3 is completely covered by a second closure element 6" in the form of a hard plastic foil, wherein the contact surface area of ​​the second closure element 6" with the first closure element 5' can be glued, welded or crimped (for example also by a key-like connection), so that it is impossible or only very difficult to separate the second closure element 6" without destroying the container 1". In this example, the open sides of the first and second closure elements 5', 6" are facing the same direction instead of opposite directions, but opposite directions are actually possible.

[0062] The shape of the cover of the closing element of the second groove 25 may be designed to be similar to the shape of the second closing element 6 ′.

[0063] In preparation for heart pump implantation, Figure 8 As shown, the heart pump 4 is first vented and moistened, and then pulled out of the closed first receiving space 3 through the opening 7 by means of the catheter or handle 26 and dragged into the sheath element located outside the first receiving space. As a result, the pump 4 is radially compressed. After that, it can be reliably held in the sheath element 11 and protected from being touched by the user.

[0064] Before being pulled out of the first receiving space, the pump 4 can be tested by letting a flushing fluid flow from the flushing system in the area of ​​the handle through the flushing opening via the conduit 8 to the pump, which is then driven via the flexible drive shaft at a speed that is significantly reduced compared to the operating speed.

[0065] exist Fig.10 In the figure, the three-dimensional form is shown. Fig. 9 A structure similar to the structure shown in cross-section in FIG.

[0066] Container 1, 1', 1" (or 11"', see Fig.11b ) With the aid of the present invention and the described method, high availability and operational reliability as well as sterility of the heart pump during implantation can be ensured.

[0067] Fig.11a and 11b A further embodiment of a receiving space is shown. Fig.11a In the figure, the receiving space is first shown, with the upper joint 9 arranged in the horizontal direction (in the direction of the channel 13 or the direction of the corresponding catheter). An additional joint 9' is arranged perpendicularly to this. The joints 9 and 9' can be provided separately or simultaneously. Closing elements 5" and 6" are provided accordingly. On the right side (opposite to the opening 7), there is another opening 7a"', which has a diameter much larger than the opening 7. Its size is such that the heart pump can be pulled in through the opening in an expanded or slightly compressed state 7a". However, after the opening 7a" is closed, the heart pump can only be pulled out through the opening 7 in a compressed state. For this case, a cover body that cannot be released in a non-destructive manner can be provided on the opening 7a". Alternatively, a cover body that can be removed without destruction (for example for manufacturer maintenance) can also be conceived. The receiving space 3" or the receiving basin 14" will be designed according to the above-mentioned embodiment. The same applies to the remaining elements already discussed (such as the channel 13, the catheter 8, the heart pump 4, etc.).

[0068] Fig.11b Another embodiment is shown, which Fig.11a The difference is that there is only one joint 9". In addition, the lower closing element (here denoted by 5') is designed to reduce the solid part. The receiving basin 14"' or the receiving space 3"' is basically as described above, and also has the opening 7, the channel 13 and the catheter or heart pump to be introduced into the receiving space. Fig.11b The cover (cross-hatched area) is shown in FIG. 1 and cannot be released from the closure 5 ″, 6 ″′ in a way that does not damage the closure. Fig.11b In the embodiment shown in FIG. 4 , a heart pump 4 is shown which has been accommodated in a receiving space 3 ″′. It can be clearly seen here that the heart pump can enter the receiving space through the opening 7a″″, but can only be taken out through the opening 7 in a compressed state. Fig.11a and 11b The embodiment shown in FIG. 1 can of course also be without a second opening or a cover, in which case the opening 7 is the only opening of the receiving spaces 3 ′ and 3 ″′. Fig.11b In it is at least indicated that the heart pump 4 is placed in the receiving space in an expanded state, and the expanded state has a diameter that allows the pump to pass through the opening 7a'' essentially without compression, but can only pass through the opening 7 when compressed.

[0069] In some cases, the handle portion 26 may not be assembled until the heart pump has entered the receiving space 3, 3', 3", 3'". After the handle has been assembled, the heart pump can only be removed in the above-described manner without causing damage.

Claims

1. A container (1, 1', 1'') for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on several sides by one or more closing elements (5, 5', 6, 6', 6'') and is closed to the outside to prevent contact with the heart pump, wherein the closing element (5, 5', 6, 6', 6'') leaves an opening (7) for a catheter (8) to pass through in order to enter the first receiving space (3) from the outside, wherein the diameter of the opening (7) is such that the heart pump can only be passed through in a condition that is at least partially compressed compared to the expanded condition; the closing element (5, 5', 6, 6', 6'') is also provided with a further opening, the diameter of which is such that the heart pump can be drawn in through it in the expanded state.

2. The container according to claim 1, characterized in that The several sides include all sides.

3. The container according to claim 1 or 2, characterized in that: The closing elements (5, 5', 6, 6', 6'') consist of a flat plastic material.

4. The container according to claim 3, characterized in that The flat plastic material is a plastic foil.

5. The container according to claim 1 or 2, characterized in that: The container (1, 1', 1") is made of a flat plastic material.

6. The container according to claim 5, characterized in that The flat plastic material is a plastic foil.

7. The container according to claim 3, characterized in that The first receiving space (3) is delimited by two half-shell-shaped closing elements (5, 5', 6, 6', 6'') connected together.

8. A container (1, 1', 1'') for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on several sides by one or more closing elements (5, 5', 6, 6', 6'') and is closed to the outside to prevent contact with the heart pump, wherein the closing elements (5, 5', 6, 6', 6'') leave an opening (7) for a catheter (8) to enter from the outside into the first receiving space (3), wherein the diameter of the opening is less than 6 mm, the opening (7) at least partially comprising a cylindrical symmetrical channel with smooth walls, the cylindrical symmetrical channel narrowing from the inside of the first receiving space to the outside; the closing elements (5, 5', 6, 6', 6'') are made of flat plastic material, and the container (1, 1', 1'') is made of flat plastic material.

9. The container according to claim 8, characterized in that The several sides include all sides.

10. The container according to claim 8, characterized in that The diameter of the opening is less than 5 mm.

11. The container according to claim 8, characterized in that The diameter of the opening is less than 4 mm.

12. The container according to claim 1 or 8, characterized in that: The first receiving space (3) is delimited by two half-shell-shaped closing elements (5, 5', 6, 6', 6'') connected together.

13. The container according to any one of claims 1 to 2, 8 to 11, characterized in that: The opening (7) through which the conduit (8) passes is formed between the two closing elements (5, 5', 6, 6', 6'') or is open to a joint (9) between the two closing elements.

14. The container according to any one of claims 1 to 2, 8 to 11, characterized in that: The first receiving space (3) is delimited by at least two closing elements joined along a joining line, wherein the joining line extends substantially perpendicularly to the passage direction of the heart pump device.

15. The container according to any one of claims 1 to 2, 8 to 11, characterized in that: The first receiving space is delimited by at least two closing elements joined along a joining line, wherein the joining line passes through a cross section in the receiving space that is larger than the cross section of the opening through which the catheter is passed when the heart pump is removed.

16. The container according to any one of claims 1 to 2, 8 to 11, characterized in that: The receiving space includes more than one opening.

17. The container according to claim 16, characterized in that In the case of a heart pump, at least one of the openings is closed by a cover which is engaged in a removable manner with or without destruction.

18. The container according to any one of claims 1 to 2, 8 to 11, characterized in that: The receiving space is configured such that the heart pump device can be introduced into the receiving space without being compressed.

19. A container (1, 1', 1'') for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on several sides by one or more closing elements (5, 5', 6, 6', 6'') and is closed to the outside to prevent access to the heart pump, wherein the closing elements (5, 5', 6, 6', 6'') leave room for a catheter (8) to pass through in order to enter the first receiving space from the outside (3) of the invention, wherein the diameter of the opening (7) is such that the heart pump can only pass through it in a condition at least partially compressed compared to an expanded condition, the closing elements (5, 5', 6, 6', 6'') are inseparably connected to each other or such that the closing elements (5, 5', 6, 6', 6'') are difficult to separate without destroying the container (1, 1', 1''); the closing elements (5, 5', 6, 6', 6'') are made of a flat plastic material and the container (1, 1', 1'') is made of a flat plastic material.

20. A container (1, 1', 1'') for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on several sides by one or more closing elements (5, 5', 6, 6', 6'') and is closed to the outside to prevent contact with the heart pump, wherein the closing elements (5, 5', 6, 6', 6'') leave an opening (7) for a catheter (8) to pass through in order to enter the first receiving space (3) from the outside, wherein the diameter of the opening (7) is such that the heart pump can only pass through in a condition at least partially compressed compared to an expanded condition, the first closing element being designed as part of a blister which at least receives the catheter (8), the first receiving space forming a receiving shell (14) for a biocompatible fluid in the region of the first closing element; the blister also receives other additional components of the heart pump device.

21. A container (1, 1', 1'') for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on several sides by one or more closing elements (5, 5', 6, 6', 6'') and is closed to the outside to prevent access to the heart pump, wherein the closing elements (5, 5', 6, 6', 6'') leave an opening for a catheter (8) to pass through in order to enter the first receiving space (3) from the outside. An opening (7), wherein the diameter of the opening (7) is such that the heart pump can only pass through it under a condition at least partially compressed compared to an expanded condition, the opening (7) at least partially comprising a cylindrical symmetrical channel with smooth walls, the opening having a protruding portion on the outside of the closing element (5, 5', 6, 6', 6''), the protruding portion comprising an edge, a hollow cylindrical sheath element (11) being arranged on the edge, the hollow cylindrical sheath element (11) being able to move along the catheter (8) and being able to be supported in the axial direction of the channel.

22. A container (1, 1', 1'') for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable heart pump (4), wherein the first receiving space (3) is delimited on several sides by one or more closing elements (5, 5', 6, 6', 6'') and is closed to the outside to prevent access to the heart pump, wherein the closing elements (5, 5', 6, 6', 6'') leave an opening (7) for a catheter (8) to pass through in order to enter the first receiving space (3) from the outside, wherein the diameter of the opening (7) is such that the heart pump can only be opened when in contact with the expanded The container has a heart pump device, wherein a compressible and expandable heart pump (4) is located in the first receiving space (3), and wherein a catheter (8) connected to the heart pump extends outward from the first receiving space (3) through the opening (7), wherein the sheath element (11) through which the catheter passes is arranged on the catheter in a freely movable manner; the catheter (8) is surrounded by the sheath element (11) on the front side of the opening (7), and the sheath element (11) is designed as a flexible plastic protrusion in the form of a hose segment, and the hose segment has a predetermined breaking position to form a peel-off sheath.

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