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

Abstract

To provide a container for a cardiac pump device that can reliably protect the components of the cardiac pump device, keep them sterile, and reduce and remove the risk of contamination. [Solution] The present invention relates to a container 1' for a cardiac pump device having a first receiving space 3 for a compressible cardiac pump 4, wherein the first receiving space 3 is partitioned on multiple sides, particularly on all sides, by one or more closure elements 5', 6' which are closed from the outside to prevent contact with the cardiac pump 4, and the closure elements 5', 6' leave open an opening 7 through which a catheter 8 entering the first receiving space 3 from the outside passes, and the diameter of the opening 7 is such that the cardiac pump 4 can pass through the opening in a partially compressed state compared to at least an expanded state.

Description

Technical Field

[0001] The present invention relates to the field of mechanical engineering, i.e., precision engineering, and to fields where it can be advantageously applied in the field of medical technology. The present invention is particularly directed to an advantageous packaging of a heart pump device.

Background Art

[0002] Artificial heart pumps have increasingly been applied in recent years to assist or replace the heart function of patients. Basically, such pumps are operated either inside or outside the patient's body. However, it is often desirable to implant such pumps inside the patient's body.

[0003] In this context, pumps are known that can be implanted in a small size inside the patient's body and can be expanded, and that can vary the degree of compression and expansion very greatly. One special type of such a pump has a rotatable rotor that delivers blood axially, and preferably, the rotor with the pump casing may be installed and operated in the region of the ventricle or aorta. The conveyance of such a pump into the patient's body is effected, for example, through a blood vessel connected to the heart.

[0004] Of course, reliable sterility is required for the production, conveyance, and preparation for implantation of such a heart pump system. This is because the components of the heart pump device may be at risk if they are not removed from the sterile packaging professionally and carefully. In particular, the implanted components must be protected from contact with objects outside the patient's body. For example, contamination by lint can also significantly impair the function of such a pump, and incorrect contact with the hand can also cause fatal damage depending on the situation.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In light of this background, the object of the present invention is to provide a container for a cardiac pump device that can reliably protect the components of the cardiac pump device, keep them in a sterile state, and reduce and eliminate the risk of contamination. [Means for solving the problem]

[0006] According to the present invention, this objective is achieved by the features of independent claim 1 or 2. The design is specified in the dependent claim.

[0007] Specifically, the present invention relates in particular to a container for a cardiac pump device having a first receptive space for a compressible and expandable cardiac pump, wherein the first receptive space is demarcated on several sides, particularly all sides, by one or more closure elements that are closed from the outside to prevent contact with the cardiac pump, the closure elements leaving an opening for a catheter to pass through entering the first receptive space from the outside, the diameter of which is such that a cardiac pump in a compressed state can pass through it, at least partially compared to an expanded state.

[0008] Therefore, the cardiac pump device comprises at least one compressible and expandable cardiac pump, and optionally additional components such as a catheter and / or catheter rinsing device, a drive shaft for the cardiac pump passing through the inside of the catheter, or optionally yet another component.

[0009] A container is to be provided for such a cardiac pump device. This container comprises a first receiving space in which the cardiac pump can be housed, protected by a closure element from, for example, contact by an operator. Thus, the closure element can close the closure space to a liquid-tight state, except for an opening through which a catheter passes. However, a closure element having an opening can also be envisioned, where one of the multiple closure elements is configured, for example, as a grid. This can, for example, make it possible to view the cardiac pump located within the first receiving space. However, at least a portion of the closure element may be designed to be optically transparent, allowing visualization of the first receiving space.

[0010] The opening through which the catheter passes serves to guide the catheter, which is directly connected to the heart pump, and advantageously has space in a second receiving space outside the first receiving space of the container that can accommodate the entire length of the catheter. Finally, the grip positioned on the catheter for manipulation may have a third receiving space in the container, and likewise be surrounded on all sides, for example, by the walls of the container.

[0011] The diameter of the opening must be such that, during removal, the pump cannot pass through the opening in its expanded state (the opening may initially be large in the packaged state and is not closed by the cover until it reaches the subsequent state). For example, one can consider an expanded pump mounted in a first receiving space for operational testing. The pump's rotor is rotated by a drive shaft operated via a catheter, for example, to test the ease of operation of the cardiac pump. The limitation of the opening dimensions prevents the expanded cardiac pump from simply being removed from the first receiving space, for example, by being drawn out via a catheter. Crucially, this means that the pump and pump head cannot be touched by hand. The risk of accidental contact with the cardiac pump is thus further reduced. The dimensions of the opening also allow the cardiac pump to be at least partially compressed when drawn out of the first receiving space, so that it can be directly drawn into a sheath mounted in the opening region outside the first receiving space, which receives the pump in at least partially compressed state. The diameter of the opening can be assumed to be less than 6 mm, preferably less than 5 mm, and particularly preferably less than 4 mm.

[0012] An advantageous design for a container according to the present invention envisions at least a closure element, particularly a complete container, formed essentially from a plastic material, especially plastic foil. The container can be manufactured, for example, as a so-called blister of plastic foil having bending rigidity. However, thicker plastic material can also be provided, and part of the container can be composed of plastic elements that can be produced by injection molding. When the container is essentially composed of a blister, it can be formed from plastic foil by deep drawing or pressing.

[0013] A further advantageous design of the present invention envisions a first receptive space that is essentially separated by the joining of two half-shell-like closing elements. The receptive space may comprise, for example, a first half-shell in the shape of a recess that partially separates the first receptive space for receiving a heart pump, and at least one further closing element as a half-shell that can be placed on the first half-shell to completely close the first receptive space. The second half-shell is thus in the form of a cover and can be advantageously connected to the first half-shell by pressing, bonding, welding, or other joining methods so that it cannot be removed unless it is destroyed. To this end, it can be ensured that the heart pump is positioned in the receptive space by the manufacturer and is still in the first receptive space before implantation application, and that it cannot be removed from there in between.

[0014] Therefore, the present invention can assume that the closing elements are connected to each other in a way that makes them impossible or difficult to release.

[0015] The two half-shells can be overlapped by having their openings face each other or by aligning their openings to correspond to each other.

[0016] Furthermore, it can be advantageously assumed that the opening is formed to allow a catheter to pass between two closure elements, or that it is open toward the junction between two closure elements. This makes it possible to insert the cardiac pump and the catheter connected to it into the opening in a particularly simple manner before joining several closure elements to partition the first receiving space.

[0017] As described above, it can be advantageously assumed that the first closure element is designed as part of a blister capable of receiving at least one catheter, particularly another additional component of a cardiac pump device.

[0018] Furthermore, the first closure element in the region of the first receptive space can be envisioned to form a fluid-retaining depression. This allows the cardiac pump within the first receptive space to be easily wetted with fluid for commissioning. This wetting is advantageous for further compression without damaging the pump. The fluid can be supplied to the cardiac pump, for example, via a catheter. The capture shell ensures that the fluid collects around the pump, thereby reliably wetting the cardiac pump, while on the other hand, it ensures that it does not leak out of the first receptive space uncontrollably.

[0019] The present invention can also be advantageously designed by an opening composed of at least a portion of a cylindrical symmetric channel. Preferably, such a cylindrical symmetric channel having smooth walls allows the cardiac pump to be drawn in with simultaneous compression without damaging the cardiac pump casing. Preferably, the cylindrical symmetric channel can be assumed to narrow from the inside outward of the first receiving space, and there are no sharp edges in the region through which the pump passes.

[0020] A cylindrical symmetric channel for this purpose can be designed, for example, to be conical or conical in cross-section. For example, the channel may be provided with an inlet funnel at the outlet to the interior of this first receiving space, which can draw in the cardiac pump at least during partial compression.

[0021] Furthermore, the closure element and the exit of the opening to the outside of the first receiving space include a rim capable of supporting a replaceable, hollow cylindrical sheath element along the catheter in the axial direction of the channel.

[0022] Sheaths in the form of hollow cylindrical components, particularly radially removable sheaths that can be broken, for example, when torn open, are components of a cardiac pump device that can be drawn onto a catheter, that is, the catheter can be drawn into the sheath, and are usually already located within a container. Such a sheath element can be pressed against the edge of the opening on the closure element from outside the first receiving space, so that the cardiac pump can be drawn out of the first receiving space through the opening and drawn into the sheath element by the catheter passing through the sheath element. As a result, the cardiac pump is already at least partially compressed radially within the opening of the receiving space and is further compressed radially when it enters the sheath element. However, since the inner diameter of the sheath element corresponds to the diameter of the cardiac pump already compressed within the opening of the receiving space, it can be assumed that there is no further compression when drawing it into the sheath. The edge of the opening may advantageously have an annular surface extending perpendicular to the long axis of the opening.

[0023] Once the cardiac pump is drawn into the sheath element, the cardiac pump device can be removed from the container and introduced into the patient's body via an introduction sheath. Therefore, the sheath element is connected to the introduction sheath, and the cardiac pump moves from the sheath element to the introduction sheath. If the sheath element is designed as a detachable sheath, it can be removed without issue after the cardiac pump has been introduced into the introduction sheath. However, the sheath element itself can be used as an introduction sheath, for example, introduced into the patient via a guidewire by a sheath element containing a compressed pump. A separate lumen for the guidewire needs to be provided for this purpose.

[0024] The invention further relates to a container of a corresponding embodiment having a heart pump device, separate from the above type of container. The compressible and expandable heart pump is located within a first receiving space, and a catheter connected to the heart pump protrudes from the first receiving space through an opening. In particular, a sheath element through which the catheter passes is provided displaceably thereon.

[0025] The invention further relates to a method of operating a heart pump device in which the heart pump is arranged in a first receiving space of a container according to any one of claims 1 to 17. For example, it is rotationally driven externally by a shaft passing through a catheter up to the heart pump (however, a pump with a motor integrated into the pump head is also possible). This method enables the functional capabilities of a heart pump having a rotor to be tested within the container without the risk of contact and without the risk of creating a non-sterilized state. The test operation is usually performed at a speed lower than the operating speed within the patient's body, for example, 50%, particularly 30% or 10% of the maximum speed.

[0026] Therefore, it can be advantageously assumed that liquid is delivered to the heart pump along the catheter through an opening provided in the catheter. This ensures that the heart pump can be tested while in contact with liquid under realistic conditions. The heart pump device may be filled with liquid as much as possible while significantly avoiding the entrapment of air during implantation. Biocompatible rinsing liquids, such as physiological saline, glucose solution, etc., can also be considered as the liquid delivered to the heart pump.

[0027] The invention further relates to a method of operating a heart pump device in which the heart pump is arranged in a first receiving space of a container according to any one of claims 1 to 17. The heart pump can be connected to a catheter that protrudes from the first receiving space through an opening. When radially compressed, the heart pump is pulled out of the first receiving space through the opening by the catheter and retracted into a sheath element that is axially displaceable (in the so-called longitudinal direction of the catheter) on the catheter.

[0028] This object, as specified in the independent claims, includes, among other things, one or more closing elements that delimit a receiving space for a compressible heart pump. The "receiving space" should preferably be understood as the smallest coherent space that completely surrounds the pump head of the heart pump (for example, other parts connected to the removal opening 7 (see the following figures) are not included in this). This can prevent contact with the heart pump, that is, the heart pump is protected from contact within the receiving space. The closing element leaves at least one opening through which the catheter passes, and the diameter of the opening is dimensioned such that a heart pump in a compressed state can pass through it, compared to when it is at least partially in an expanded state. Thus, "the catheter passes through" should be understood as the corresponding catheter passing through this opening, and preferably should not be understood as a specific passing direction. In the independent claims, it is referred to as "one or more closing elements". In particular, in the case of "several closing elements", they may have different designs. This means that the closing elements forming the receiving space can be joined to each other in different ways. This connection can be realized as a screw connection. The joining can preferably be made such that they do not separate unless damaged, but they may also be manufactured so that they cannot be broken. Thus, for example, an expanded pump can be accommodated in the receiving space by joining these closing elements "around the pump" to each other, and then they cannot be separated from each other unless damaged. In this regard, the joining line connecting different closing elements to each other can be arranged in the longitudinal direction of the catheter protruding from the opening of the receiving space, or can be arranged perpendicular to this direction. More details will be specified below regarding this.

[0029] In an embodiment, the first receiving space is delimited by at least two closing elements joined along a joining line, and the joining line extends within a cross-section of the receiving space that is larger than the cross-section of the opening through which the catheter passes. In this way, the closing elements can be joined "around the pump head", and the subsequent removal of the heart pump (of the pump head) is only possible during compression.

[0030] Further embodiments assume that the receiving space has one or more openings. For example, a compressible and expandable cardiac pump can be retracted into the receiving space so that an expandable cardiac pump can be inserted into the receiving space without being essentially compressed. However, removal of the pump head (preferably located at the opposite end of the receiving space) is only possible under compression (see, for example, Figure 11a).

[0031] Further development would assume that at least one opening in the receiving space is closed by a cover bonded over the opening in the receiving space, so that it can be removed with or without destruction. Thus, for example, as described above, the pump can first be pulled into the receiving space through a larger opening (without the need to forcibly compress the cardiac pump). This can then be closed with the cover so that it cannot be released unless the cover is destroyed. In this way, it is ensured that the cardiac pump cannot be removed from the receiving space by the user without compression.

[0032] An opening can be provided in the receiving space so that the cardiac pump device / cardiac pump / pump head can be introduced into the receiving space without compression, and can be removed exclusively in a state that is at least partially compressed, compared to an expanded state.

[0033] The present invention is illustrated by the following drawings and the embodiments shown in the drawings described later. [Brief explanation of the drawing]

[0034] [Figure 1] This is a schematic diagram showing a cross-section of the container according to the present invention. [Figure 2] This figure shows a cross-section of a container having a heart pump according to the present invention. [Figure 3] This is a diagram showing the container in a further cross-section. [Figure 4] This is a diagram showing a cardiac pump with a catheter. [Figure 5] This is a plan view of a container having a heart pump. [Figure 6]This is a cross-sectional view through a vessel having a cardiac pump and a sheath element. [Figure 7] These are different cross-sectional views of the container and the sheath element. [Figure 8] This is a three-dimensional view of a container in the form of a blister pack. [Figure 9] This is a cross-sectional view through a container designed as a blister pack. [Figure 10] This is a three-dimensional diagram showing the details of a container designed as a blister pack. [Figure 11a] This is a cross-sectional view of a further embodiment of the container according to the present invention. [Figure 11b] This is a cross-sectional view of a component of a further embodiment of the container according to the present invention. [Modes for carrying out the invention]

[0035] Figure 1 shows a cross-section of a container 1 having two closure elements 5 and 6. The first closure element 5 is designed as a solid body, and the second closure element 6 closes the first receiving space 3 as a thin-walled half-shell in the form of a cover. An opening 7 is provided in the region of the closure elements 5 and 6, specifically as a recess within the first closure element 5, through which the catheter can exit the first receiving space 3 into the outside space. A groove 13 is provided for receiving the catheter, which may extend annularly toward the distal end of the container 1 to accommodate one or more loops of the catheter. The representation of the first closure element 5 as solid is for illustrative purposes only to illustrate its basic function.

[0036] The first closing element 5 forms a liquid-tight recess 14 into which the heart pump can be inserted and into which fluid can be supplied for commissioning.

[0037] The second closure element 6 is preferably inextricably connected to the first closure element 5 in the region of the joint position 9, and is sealed, and the connection is advantageously designed to be liquid-tight but not airtight, with the exception of the opening 7 (where air needs to escape from the catheter). In this example, the joint position 9 here forms a joint line or annular joint surface that lies in the plane overall.

[0038] The second closure element 6 can be designed to be liquid-tight as a curved, flat plastic component, preferably a rigid foil, but may include an opening and / or one or more optical windows so as to allow viewing into the first receiving space 3. The critical aspect of the second closure element 6 is that it protects the cardiac pump held within the first receiving space 3 from contact.

[0039] A container 1' having a first closure element 5' as a second closure element 6' designed as a rigid foil in blister form is shown in Figure 2. A first receiving space 3 is formed as an example of the embodiment shown in Figure 1, and a cardiac pump 4 positioned within the first receiving space 3 is schematically shown in Figure 2. The cardiac pump 4 comprises a rotor 4a having a helical delivery element 4b and a hub 4c, the hub 4c being connected to a driveable, flexible drive shaft 12. The drive shaft 12 is drawn out of the cardiac pump 4 through a catheter 8 passing through an opening 7.

[0040] The cardiac pump 4 is shown in an uncompressed state, and its radial size perpendicular to the axial direction, indicated by its hub 4c, is greater than the size of the opening 7.

[0041] Figure 3 shows the portion already indicated as III in Figure 2. It shows the first closure element 5', the second closure element 6', and the opening 7, as well as the catheter 8 having the drive shaft 12, and the outline of the cardiac pump 4 is also drawn with a dotted line. As is clear from Figure 3, the diameter of the cardiac pump 4 is larger than the opening width of the opening 7, so that during simultaneous radial compression, only the cardiac pump 8 on the catheter 8 can be withdrawn from the first receiving space 3 through the opening 7.

[0042] Figure 4 shows the cardiac pump device, which includes the cardiac pump 4, catheter 8, and drive shaft 12, as already described in Figure 2. It also shows the drive-side end of the drive shaft 12, which has a magnetic coupling 15. The coupling enables the transmission of drive motion from the motor 16 to the inside of the container 17, and the drive shaft 12 is connected to the magnetic coupling.

[0043] The container 17 also functions as a rinsing device having several rinsing openings 18 and 19, introducing rinsing fluid, such as saline solution, into the container 17 through opening 18 and removing excess rinsing fluid through a second rinsing opening 19. The rinsing fluid further moves along the catheter 8 toward the pump 4, and is delivered toward the pump 4 by the helical shape of the drive shaft 12, especially during rotor operation, i.e., when the drive shaft 12 is rotating. Thus, for commissioning, rinsing fluid is supplied through the first rinsing opening 18 and moved from the catheter 8 toward the pump 4, while the pump, located within the first receiving space 3, can be commissioned at least at a low speed while being wetted with rinsing fluid.

[0044] Figure 5 is a top view showing the first closure element 5' and the interior of the first receiving space 3 in which the cardiac pump 4 is positioned. The catheter 8 connected to the cardiac pump 4 protrudes through the opening 7, and the outside of the receiving space 3 in front of the opening 7 is surrounded by a sheath element 11. The sheath element 11 is designed, for example, as a flexible plastic annular body in the form of a hose section with a predetermined break point, which can be peeled off radially as a sheath after the pump 4 has been inserted into the patient's body introduction sheath in a later stage.

[0045] The sheath element 11 is placed over the edges of the openings 7 of the closure elements 5', 6' in the first receiving space 3 from the outside, and the pump 4 can be drawn out of the receiving space 3 via the catheter in the direction of arrow 20. When the pump 4 is drawn into the opening 7, it is radially compressed in the direction of arrows 21, 22 by any diameter of the opening 7 that is smaller than the diameter of the pump in its expanded state, and is drawn into the sheath element 11 in a compressed or at least partially compressed state. There, protected again from contact and contamination, it is removed from the container 1' and moved to the introduction sheath on the patient's body.

[0046] Figure 6 again shows a schematic side view of a container 1' having a first receiving space 3 in which the pump 4 is located, and a sheath element 11 that is placed in the groove 13 of the container 1' and surrounds the catheter 8.

[0047] Figure 7, another diagram showing the direction of arrow 23 in Figure 6, is an external view of the closing elements 5', 6' having the opening 7, and is a plan view of the sheath element 11 viewed in the axial direction, with the cardiac pump 4 located in the first receiving space 3 represented by a dotted line.

[0048] Figure 8 is a perspective view showing the first closure element 5'. Two recesses are designed as part of the blister, of which the first recess 24 is demarcated by the first closure element 5' and forms the lower part of the first receiving space for the cardiac pump, while the second recess 25 demarcates a third receiving space for gripping the catheter 8. A groove 13 can be further recognized, which runs from the first recess 24 to the second recess 25 and forms a second receiving space for arranging the catheter. Another arched groove 13a is also formed, which allows for arranging the catheter loop. Grip recesses 27 and 28 are further provided in the region of groove 13, which serve, on the one hand, to stabilize the blister, and on the other hand, to improve the grip of the catheter located in groove 13 and to form a projection on the blister that acts as a support element when removing and when placing it on a horizontal surface adjacent to the recesses 24 and 25.

[0049] The cardiac pump 4 and grip portion 26 are exposed within the container 1'' or within the closure element 5'. However, typically the closure element is provided on the first recess 24 and the second recess 25, covering the respective recesses and internal components, protecting them from contact and vibration, thereby completing the container 1''. For this reason, the non-traumatic tip of the catheter (the so-called pigtail tip) is also fixed, preventing excessive movement of the pump head, while not prohibiting withdrawal in the direction of the sheath element 11.

[0050] A cross-section passing through the recess 24 is shown in Figure 9 for illustrative purposes, and is formed in the first closure element 5' which is formed as part of the blister. A ridge 29 formed by a suitable prominent arch of the closure element 5' is formed within the recess and the first receiving space 3, and the ridge 29 itself forms a recess 30, which receives the heart pump 4 inside the first receiving space 3. This forces the heart pump 4 into precise and secure position within the first receiving space 3. The first receiving space 3 is further completely covered by a second closure element 6'' in the form of a rigid plastic foil, and the second closure element 6'' in the area of ​​the contact surface with the first closure element 5' can be bonded, welded, or pressed (for example, in a connection method similar to a push button), so that removal of the second closure element 6'' is impossible or extremely difficult unless the container 1'' is destroyed. In this example, the open sides of the first and second closure elements 5', 6'' are oriented in the same direction and are not facing each other, although it is possible.

[0051] The cover shape of the closing element that covers the second recess 25 may be designed to be similar in shape to the second closing element 6''.

[0052] When preparing for the implantation of the cardiac pump as shown in Figure 8, the air inside is first removed and it is moistened, and then the cardiac pump 4 on the catheter or grip 26 is withdrawn from the closed first receiving space 3 through the opening 7 and drawn into the sheath element located outside the first receiving space. This compresses the pump 4 radially. It is then securely held in the sheath element 11 and protected from contact by the user.

[0053] The pump 4 can be commissioned with a rinsing fluid that travels from the rinsing system located in the grip area through the rinsing opening to the pump via the catheter 8 before being withdrawn from the first receiving space. The pump is then driven by a flexible drive shaft at a speed significantly reduced compared to its operating speed.

[0054] The configuration shown in cross-sectional form in Figure 9 is now shown in a similar three-dimensional representation in Figure 10.

[0055] The containers 1, 1', 1'' (or 11'', see Figure 11b) according to the present invention and as described can ensure high availability and operational reliability, as well as sterility of the cardiac pump when implanted.

[0056] Figures 11a and 11b show further embodiments of the receiving space. The receiving space is first shown in Figure 11a, with the connection points 9 aligned horizontally (towards the groove 13 or the corresponding catheter). Connection point 9'' is further provided perpendicular to this. These connection points 9 and 9'' may be provided on their own or further overlapping. Closure elements 5'' and 6'' are provided accordingly. Furthermore, an opening 7a'''' with a diameter considerably larger than the diameter of the opening 7 is provided on the right side (opposite the opening 7). The dimensions are such that the cardiac pump can be drawn in in an expanded or slightly compressed state. However, after closing the opening 7a'', the cardiac pump can be drawn out through the opening 7 while compressed. In this case, a cover that cannot be opened without destruction may be provided over the opening 7a''. Alternatively, it is conceivable that the cover can be separated without destruction (e.g., by overhauling by the manufacturer). The receiving space 3'' or fluid-retaining recess 14'' is designed according to the embodiments described above. The same applies to the remaining elements already discussed in the above explanation (e.g., groove 13, catheter 8, cardiac pump 4, etc.).

[0057] Figure 11b shows a further embodiment, differing from Figure 11a only in the presence of a joint position 9''. Furthermore, a lower closure element (indicated here as 5'') is designed to be solid. The recess 14''' or receiving space 3'''' is essentially as described above, and the same applies to the opening 7, the groove 13, and the catheter or cardiac pump that transports into the receiving space. A cover is shown in Figure 11b (shaded), and this cover cannot be released from the closure elements 5''' and 6''' unless it is destroyed. A cardiac pump 4 housed in the receiving space 3''' is illustrated in the embodiment shown in Figure 11b. This allows the cardiac pump to be transported through the opening 7''' to the receiving space, but it is clear that it can only be removed from the opening 7 during compression. The embodiments shown in Figures 11a and 11b may, of course, be without a second opening or cover, in which case the opening 7 is only the opening of the receiving spaces 3'' and 3''''. Figure 11b shows that at least the cardiac pump 4 is in the receptive space 3''' in the expanded state, and this expanded state has a diameter such that the pump can pass through the opening 7a''' without being compressed in essence, but can pass through the opening 7 only in the compressed state.

[0058] In some cases, the grip section 26 may not be assembled until after the cardiac pump has been transported into the receiving spaces 3, 3', 3'', 3''''. The pump can be removed after the grip is assembled without damaging it, as described above.

[0059] [Note][1] A container (1, 1', 1'') for a cardiac pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable cardiac pump (4), wherein the first receiving space (3) is demarcated on several sides, particularly on all sides, by one or more closure elements (5, 5', 6, 6', 6'') that are closed from the outside to prevent contact with the cardiac pump, the closure elements (5, 5', 6, 6', 6'') leaving an opening (7) through which a catheter (8) entering the first receiving space (3) from the outside passes, the diameter of the opening (7) is such, at least in part, that the cardiac pump in a compressed state compared to an expanded state can pass through the container. [2] A container (1, 1', 1'') for a cardiac pump device (4, 8, 12, 17, 18, 19, 26) having a first receptive space (3) for a compressible cardiac pump (4), wherein the first receptive space (3) is demarcated on several sides, particularly on all sides, by one or more closure elements (5, 5', 6, 6', 6'') that are closed from the outside to prevent contact with the cardiac pump (4), the closure elements (5, 5', 6, 6', 6'') leaving an opening (7) for a catheter (8) to enter the first receptive space (3) from the outside, the diameter of which is less than 6 mm, preferably less than 5 mm, and particularly preferably less than 4 mm. [3] The container according to [1] or [2], wherein at least the closure elements (5, 5', 6, 6', 6''), particularly the complete container (1, 1', 1''), are made of a flat plastic material, particularly plastic foil. [4] The container according to [1], [2] or [3], characterized in that the first receiving space (3) is essentially separated by two half-shell shaped, interconnected closure elements (5, 5', 6, 6', 6''). [5] The container according to any one of [1] or [2] to [4], characterized in that the closure elements (5, 5', 6, 6', 6'') are inextricably connected to each other.[6] The container according to any one of [1] or [2] to [5], wherein the opening (7) is formed to allow a catheter (8) to pass between two closure elements (5, 5', 6, 6', 6'') or is open toward the junction (8) between the two closure elements. [7] The container according to any one of [1] or [2] to [6], wherein the first closure element (5, 5') is designed as part of a blister capable of receiving at least one catheter (8), in particular an additional other component of a cardiac pump device. [8] The container according to [7], wherein the first closure element (5, 5') in the region of the first receiving space forms a fluid-retaining depression (14). [9] The container according to any one of [1] or [2] to [8], wherein the opening (7) comprises at least a partially cylindrical symmetric channel.

[10] The container according to [9], wherein the cylindrical symmetric channel narrows from the inside outward of the first receiving space (3).

[11] The container according to

[10] , characterized in that the exit of the opening to the outside of the closure elements (5, 5', 6, 6', 6'') includes a rim capable of supporting a replaceable hollow cylindrical sheath element (11) along the catheter (8) in the axial direction of the channel.

[12] The container according to any one of [1] to

[11] , having a cardiac pump device, wherein a compressible and expandable cardiac pump (4) is located within the first receiving space (3), and a catheter (8) connected to the cardiac pump protrudes from the first receiving space (3) through the opening (7), and in particular, the sheath element (11) through which the catheter passes is provided to be displaceable on the catheter.

[13] The container according to any one of [1] to

[12] , characterized in that the first receiving space (3) is demarcated by at least two closure elements joined along a joint line, the joint line extending essentially perpendicular to the direction through which the cardiac pump device passes.

[14] The container according to any one of [1]1 or

[13] , wherein the first receiving space is demarcated by at least two closing elements joined along a joint line, the joint line extending into a cross-section of the receiving space that is larger than the cross-section of the opening through which a catheter passes when the cardiac pump is removed.

[15] The container according to any one of [1] to

[14] , wherein the receiving space has one or more openings.

[16] The container according to

[15] , wherein, with the cardiac pump installed, at least one of the openings is closed by a cover that is joined to be removable by or without destruction.

[17] The container according to any one of [1] to

[16] , wherein the receiving space is arranged so that the cardiac pump device can be introduced into the receiving space without compression.

[18] A method for operating a cardiac pump device, wherein the cardiac pump is positioned in a first receiving space (3) of a container (1, 1', 1'') described in any one of [1] to [7], wherein the cardiac pump is externally rotationally driven by a shaft (12) that passes through a catheter (8) to the cardiac pump (4).

[19] The method according to

[18] , further characterized in that a liquid is delivered along the catheter (8) to the cardiac pump (4) through openings (18, 19) provided in the catheter (8).

[20] A method for operating a cardiac pump device, wherein a cardiac pump (4) is positioned in the first receiving space (3) of a container (1, 1', 1'') according to any one of [1] to

[17] , wherein the cardiac pump (4) is connected to a catheter (8) protruding from the first receiving space (3) through the opening (7), and the cardiac pump (4) is drawn out of the first receiving space (3) through the opening by the catheter (8) during radial compression and drawn into a sheath element (11) that is axially displaceable on the catheter (8).

Claims

1. A container (1, 1', 1'') for a cardiac pump device (4, 8, 12, 17, 18, 19, 26) having a first receiving space (3) for a compressible and expandable cardiac pump (4), wherein the first receiving space (3) is demarcated on several sides by one or more closure elements (5, 5', 6, 6', 6'') that are closed from the outside to prevent contact with the cardiac pump, the closure elements (5, 5', 6, 6', 6'') leaving an opening (7) through which a catheter (8) entering the first receiving space (3) from the outside passes, the diameter of the opening (7) being such that the cardiac pump in a compressed state compared to the expanded state can pass through it, and the container (1, 1', 1'') further comprises a groove (13) for receiving the catheter (8).

2. The container according to claim 1, wherein the grip recess is provided in the region of the groove (13).

3. The container according to claim 1 or 2, wherein the groove (13) is formed in at least one of the closing elements (5, 5', 6, 6', 6'').

4. The container according to any one of claims 1 to 3, wherein the groove (13) for receiving the catheter (8) extends in an annular shape toward the distal end of the container.

5. The container according to any one of claims 1 to 4, wherein the container (1, 1', 1'') has a space in a second receiving space outside the first receiving space (3) that can accommodate the entire length of the catheter (8).

6. The container according to any one of claims 1 to 5, wherein the third receiving space of the container (1, 1', 1'') has a space for receiving a grip that is placed on the catheter (8) for manipulation.

7. The container according to any one of claims 1 to 6, wherein at least the closing elements (5, 5', 6, 6', 6''), in particular the complete container (1, 1', 1''), are made of a flat plastic material, in particular plastic foil.

8. The container according to any one of claims 1 to 7, characterized in that the first receiving space (3) is essentially separated by two half-shell shaped, interconnected closing elements (5, 5', 6, 6', 6'').

9. The container according to any one of claims 1 to 8, wherein the first receiving space (3) comprises a first half-shell having the shape of a recess that partially demarcates the first receiving space for receiving the heart pump, and at least one further closing element that rests on the first half-shell and serves as a half-shell for completely closing the first receiving space.

10. The container according to any one of claims 1 to 9, wherein the opening (7) is formed to allow a catheter (8) to pass between two closure elements (5, 5', 6, 6', 6'') or is open toward a junction between two closure elements.

11. The container according to any one of claims 1 to 10, characterized in that the first closing element (5, 5') is designed as part of the blister.

12. The container according to any one of claims 1 to 11, wherein the first closing element (5, 5') also receives at least the catheter (8).

13. The container according to claim 12, wherein the first closing element (5, 5') further receives a portion of the cardiac pump device.

14. The container according to any one of claims 1 to 13, characterized in that the first closing element (5, 5') in the region of the first receiving space forms a recess (14) for capturing liquid.

15. The container according to any one of claims 1 to 14, characterized in that the opening (7) comprises at least a partially cylindrical symmetric channel.

16. The container according to claim 15, characterized in that the cylindrical symmetric channel narrows from the inside outward of the first receiving space (3).

17. The container according to claim 15, characterized in that the exit of the opening to the outside of the closing elements (5, 5', 6, 6', 6'') includes a rim capable of supporting a replaceable hollow cylindrical sheath element (11) along the catheter (8) in the axial direction of the channel.

18. A container according to any one of claims 1 to 17, comprising a cardiac pump device, wherein a compressible and expandable cardiac pump (4) is located within a first receiving space (3), and a catheter (8) connected to the cardiac pump protrudes from the first receiving space (3) through an opening (7), and in particular, a sheath element (11) through which the catheter passes is provided to be displaceable on the catheter.

19. The container according to any one of claims 1 to 18, wherein the sheath, in the form of a hollow cylindrical component, is a component of the heart pump device located inside the container.

20. The container according to claim 19, wherein the hollow cylindrical component is a peeling sheath.

21. The container according to any one of claims 1 to 20, wherein the first receiving space (3) is demarcated by at least two closing elements joined along a joint line, the joint line extending essentially perpendicular to the direction in which the cardiac pump device passes.

22. The container according to any one of claims 1 to 21, wherein the first receiving space is demarcated by at least two closing elements joined along a joint line, the joint line extending into a cross-section of the receiving space that is larger than the cross-section of the opening through which a catheter passes when the cardiac pump is removed.

23. The container according to any one of claims 1 to 22, wherein the receiving space has one or more openings.

24. The container according to claim 23, wherein, with the cardiac pump installed, at least one of the openings is closed by a cover that is attached in a manner that allows it to be removed, either by breaking or without breaking.

25. The container according to any one of claims 1 to 24, characterized in that the receiving space is arranged so that the cardiac pump device can be introduced into the receiving space without compression.

26. A method for operating a heart pump device, wherein the heart pump is positioned in the first receiving space (3) of a container (1, 1', 1'') according to any one of claims 1 to 25, the method wherein the heart pump is rotationally driven from the outside by a shaft (12) that passes through the catheter (8) to the heart pump (4).

27. The method according to claim 26, further characterized in that the liquid is delivered to the cardiac pump (4) along the catheter (8) through openings (18, 19) provided in the catheter (8).

28. A method for operating a heart pump device, wherein the heart pump (4) is positioned in the first receiving space (3) of a container (1, 1', 1'') according to any one of claims 1 to 25, wherein the heart pump (4) is connected to the catheter (8) protruding from the first receiving space (3) through the opening (7), and the heart pump (4) is drawn out of the first receiving space (3) through the opening by the catheter (8) during radial compression and drawn into a sheath element (11) that is axially displaceable on the catheter (8).

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