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

Description

[0001] The invention lies in the field of mechanics and mechanical engineering, or rather, precision engineering, and is particularly advantageously applicable in the field of medical technology. In particular, the invention is directed to an advantageous packaging for a heart pump device.

[0002] Mechanical heart pumps are increasingly being used to support or replace a patient's cardiac function. In principle, such pumps can be operated inside or outside the patient's body. In many cases, however, it is desirable to implant such pumps inside the patient's body.

[0003] In this context, pumps have already become known that are highly compressible and expandable, allowing them to be implanted with small dimensions and expanded within the patient's body. A special type of such pump has a drivable rotor that pumps blood in an axial direction. The rotor, together with a pump housing, can be brought into the region of a ventricle or aorta and operated there. Such pumps can be transported into the patient's body, for example, through a blood vessel to the heart.

[0004] Of course, reliable sterility is required during the manufacture, transport, and preparation for implantation of such heart pump systems. This can be compromised if parts of the heart pump device are not removed from sterile packaging expertly and carefully. In particular, the implantable parts must be protected from contact with objects outside the patient's body. For example, lint contamination can severely impair the function of such pumps, and improper contact with hands could potentially cause critical damage. Publication WO 2014 / 164136 A1 relates to a removable interface element for a fluid handling system. The interface element comprises an interface body sized and shaped to be inserted into an interface opening of a console housing.Document D1 does not show that a first receiving space of a container for a heart pump device is delimited by at least two end elements joined along a joining line, wherein the joining line runs substantially perpendicular to a passing direction of a heart pump device.

[0005] Against this background, the present invention is based on the object of creating a container for a heart pump device which reliably protects the parts of the heart pump device, keeps them sterile and enables removal with low contamination risks.

[0006] The object is achieved according to the invention with the features of independent patent claim 1 or 2. Further embodiments are mentioned in the subclaims.

[0007] The invention therefore relates, inter alia, specifically to a container for a heart pump device with a first receiving space for a compressible and expandable heart pump, wherein the first receiving space is delimited on several sides, in particular on all sides, by one or more closing elements and is closed off to the outside to prevent contact with the heart pump, wherein the closing elements leave an opening for the passage of a catheter from the outside into the first receiving space, wherein the diameter of the opening is dimensioned such that the heart pump can only pass through it in a state that is at least partially compressed compared to the expanded state.

[0008] A heart pump device accordingly comprises at least one compressible and expandable heart pump and optionally further parts, such as a catheter and / or a catheter flushing device and a drive shaft for the heart pump running within the catheter, and optionally further parts.

[0009] A container is to be provided for such a heart pump device. This container has a first receiving space in which the heart pump can be accommodated in such a way that it is protected from contact, for example by operating personnel, by the closing elements. The closing elements can close the closing space in a fluid-tight manner with the exception of the opening for the passage of a catheter; however, it can also be provided that the closing elements have openings, for example that one of the closing elements is constructed like a grid. This can, for example, enable a visual inspection of the heart pump located in the first receiving space. However, at least some of the closing elements can also be designed to be at least partially optically transparent in order to allow a view into the first receiving space.

[0010] The catheter passage opening serves to allow the passage of a catheter directly connected to a heart pump. Advantageously, the entire length of the catheter is accommodated outside the first receiving space in a second receiving space of the container. Finally, a handle attached to the catheter for handling can also be accommodated in a third receiving space of the container and, for example, also be surrounded on all sides by the walls of the container.

[0011] The diameter of the opening should be such that the pump cannot pass through the opening in its expanded state upon removal (the opening could initially be larger during packaging and only then closed with a lid). For example, it can be provided that the pump is stored in its expanded state in the first receiving chamber so that it can be put into operation there for testing purposes. A rotor of the pump can, for example, be set in rotation by means of a drive shaft running through the catheter in order to check that the heart pump is ready for operation. The limited size of the opening ensures that the heart pump cannot simply be removed from the first receiving chamber in this expanded state, for example by being pulled out using the catheter. The decisive factor here is that the pump or pump head cannot be touched by hand.This further reduces the risk of inadvertent contact with the heart pump. The dimensions of the opening ensure that when the heart pump is pulled out of the first receiving space, it is at least partially compressed, allowing it to be drawn directly into a lock located on the outside of the first receiving space in the region of the opening, which holds the pump in an at least partially compressed state. The diameter of the opening can be less than 6 mm, preferably less than 5 mm, and particularly preferably less than 4 mm.

[0012] An advantageous embodiment of the container according to the invention provides that at least the end elements, in particular the entire container, consist essentially of a flat plastic material, in particular a plastic film. The container can, for example, be manufactured as a so-called blister pack from a rigid plastic film. However, a stronger plastic material can also be provided, or parts of the container can consist of plastic elements produced by an injection molding process. If the container consists essentially of a blister pack, it can be formed from a plastic film using a deep-drawing or compression molding process.

[0013] A further advantageous embodiment of the invention provides that the first receiving space is essentially delimited by two half-shell-shaped, joined-together closure elements. The receiving space can, for example, have a first half-shell in the form of a recess for accommodating the heart pump, which partially delimits the first receiving space, and at least one further closure element can be placed as a half-shell on the first half-shell to completely close off the first receiving space. The second half-shell, which thus forms a lid, can be connected to the first half-shell by pressing, gluing, welding, or other joining methods and is advantageously not removable without causing damage.This ensures that a heart pump which is placed in the receiving space by the manufacturer and which is still located in this first receiving space before its use during implantation cannot have been removed from it in the meantime.

[0014] The invention can thus provide that the end elements are connected to one another in a non-detachable or difficult-to-detach manner.

[0015] The two half-shells can be placed on top of each other with the openings facing each other or with the openings aligned in the same direction.

[0016] It can also be advantageously provided that the opening for the passage of a catheter is formed between two end elements or is open towards the joint between two end elements. This makes it particularly easy to insert the heart pump and the catheter connected to it into an opening before joining several end elements to define the first receiving space.

[0017] As mentioned above, it can advantageously be provided that a first of the end elements is designed as part of a blister which accommodates at least one catheter, in particular additionally further parts of a heart pump device.

[0018] It can also be provided that the first closure element forms a collecting tray for fluid in the region of the first receiving chamber. This facilitates the moistening of the heart pump with fluid in the first receiving chamber for test operation. Furthermore, the moistening is also advantageous for damage-free compression of the pump. The fluid can be supplied to the heart pump, for example, via the catheter. The collecting tray ensures that the fluid collects around the pump, thus ensuring the moistening of the heart pump, and prevents it from escaping from the first receiving chamber in an uncontrolled manner.

[0019] The invention can also be advantageously configured in that the opening consists at least partially of a cylindrically symmetrical channel. Such a cylindrically symmetrical channel, with preferably smooth walls, allows a heart pump to be pulled through while simultaneously compressing it without damaging the housing of the heart pump. Preferably, the cylindrically symmetrical channel can narrow outward from the interior of the first receiving space and has no sharp edges in the area through which the pump passes.

[0020] For this purpose, the cylindrically symmetrical channel can be conical, for example, or partially conical. The channel can, for example, have an insertion funnel at its opening toward the interior of the first receiving space, into which the heart pump can be drawn under at least partial compression.

[0021] In addition, it can advantageously be provided that the mouth of the opening to the outside of the closure elements and the first receiving space has an edge on which a hollow cylindrical lock element displaceable along the catheter can be supported in the axial direction of the channel.

[0022] A sheath in the form of a hollow cylindrical component, in particular a peel-away sheath, which can be radially removed by being destroyed when torn open, can be pulled over the catheter or the catheter can be pulled into the sheath and is usually already a component of the heart pump device located in the container. Such a sheath element can be pressed from the outside of the first receiving space against the edge of the opening on the end elements, so that the heart pump can be pulled out of the first receiving space through the opening and into the sheath element by means of the catheter, which runs through the sheath element. In this case, the heart pump is already at least partially radially compressed within the opening of the receiving space and is further radially compressed, in particular upon entering the sheath element.However, it can also be provided that the inner diameter of the sheath element corresponds to the diameter to which the heart pump is already compressed in the opening of the receiving chamber, so that further compression is eliminated when retracting into the sheath. The edge of the opening can advantageously have an annular surface running perpendicular to the longitudinal axis of the opening.

[0023] Once the heart pump has been retracted into the sheath element, the heart pump device can be removed from the container and inserted into a patient's body via an introducer sheath. To do this, the sheath element is coupled to the introducer sheath, and the heart pump is slid out of the sheath element and into the introducer sheath. If the sheath element is designed as a peel-away sheath, this can be easily removed after the heart pump has been inserted into the introducer sheath. However, the sheath element itself can also be used as an introducer sheath by inserting the sheath element with the pump compressed within it into the patient, for example, via a guidewire. For this purpose, a separate lumen for the guidewire may be required.

[0024] In addition to a container of the type described above, the invention also relates to a container of a corresponding design with a heart pump device, wherein a compressible and expandable heart pump is located in the first receiving space and wherein a catheter connected to the heart pump protrudes through the opening from the first receiving space, wherein in particular a sheath element through which the catheter passes is freely displaceable being provided on the catheter.

[0025] The invention also relates to a method for operating a heart pump device, in which a heart pump is arranged in the first receiving space of a container according to one of claims 1 to 12 and is driven in rotation from the outside, for example by means of a shaft running through a catheter to the heart pump (a pump with an integrated motor on the pump head is also possible). This method makes it possible to test the functionality of a heart pump provided with a rotor while it is still in the container, without the risk of contact and desterilization. Test operation usually takes place at speeds below the operating speed in the patient's body, for example at 50%, in particular at no more than 30% or 10% of the speed.

[0026] It can be advantageous to provide for a fluid to be pumped to the heart pump through an opening provided along the catheter. This ensures that the heart pump is tested under realistic conditions in contact with a fluid. At the same time, the heart pump device can be filled with the fluid as much as possible to largely prevent air pockets during implantation. Any conventional biocompatible flushing fluid, such as saline solution, glucose solution, or similar, can be used as the fluid pumped to the heart pump.

[0027] The invention also relates to a method for operating a heart pump device, in which a heart pump is arranged in the first receiving space of a container according to one of claims 1 to 12, wherein the heart pump is connected to a catheter which projects through the opening from the first receiving space, characterized in that by means of the catheter the heart pump is pulled out of the first receiving space through the opening under radial compression and into a lock element which is freely displaceable on the catheter in the axial direction (i.e. in the longitudinal direction of the catheter).

[0028] The subject matter listed in the independent claims includes, among other things, one or more closure elements defining a receiving space for a compressible and expandable heart pump. "Receiving space" is preferably understood to mean the smallest contiguous space that completely encloses the pump head of a heart pump (this should not include additional components adjoining, for example, a discharge opening 7 (see figures below)). This is done to prevent contact with the heart pump, i.e., to protect the heart pump from contact in the receiving space. The closure elements leave at least one opening free for the passage of a catheter, wherein the diameter of the opening is dimensioned such that the heart pump can only pass through it in a state that is at least partially compressed compared to the expanded state.Here, "for the passage of a catheter" means that a corresponding catheter passes through this opening; this preferably does not refer to a specific passage direction. The independent claims refer to "one or more closure elements." Particularly in the case of "multiple closure elements," these can be of different designs. This means that the closure elements forming the receiving space can be joined together in various ways. For example, connections can be realized as screw connections, etc. Preferably, the joint is such that it cannot be removed non-destructively, but can alternatively also be produced non-destructively. Thus, for example, an expanded pump can be accommodated in the receiving space by joining these closure elements "around the pump" and subsequently no longer being able to be separated from each other non-destructively.

[0029] The receiving chamber is defined by at least two end elements joined along a joining line, with the joining line extending across a cross-section of the receiving chamber that is larger than the cross-section of the opening for the passage of a catheter. This allows the end elements to be joined "around the pump head," and subsequent removal of the heart pump (the pump head) is only possible under compression.

[0030] A further embodiment provides for the receiving space to have more than one opening. For this purpose, it is possible, for example, for the compressible and expandable heart pump to be drawn into the receiving space in such a way that the insertion of the expandable heart pump into the receiving space can be carried out essentially without compression. However, the removal of the pump head (preferably at the opposite end of the receiving space) is then only possible under compression (see, for example, Fig. 11a ).

[0031] A further development provides that at least one of the openings of the receiving chamber is closed by a cover that is attached to this opening of the receiving chamber in a manner that is either non-destructive or removable. For example, it is possible, as described above, to first pull a pump into the receiving chamber through the larger opening (which does not necessarily force compression of the heart pump). It is then possible to close this opening with a cover in such a way that the cover cannot be removed non-destructively. This ensures that the heart pump cannot be removed from the receiving chamber by a user without compression.

[0032] It is therefore possible to provide the receiving space with openings in such a way that the heart pump device / the heart pump / the pump head can be inserted into the receiving space without compression, but can only be removed in a state that is at least partially compressed compared to the expanded state.

[0033] In the following, the invention is shown and described using an exemplary embodiment in figures of a drawing. Fig. 1 shows a schematic cross-section of a container according to the invention, Fig. 2 shows a cross-section of an exemplary container with a heart pump, Fig. 3 shows a container in a further cross-section, Fig. 4 shows a heart pump with a catheter, Fig. 5 shows a plan view of a container with a heart pump, Fig. 6 shows a cross-section through a container with a heart pump and a lock element, Fig. 7 shows another cross-section through a container and a lock element, Fig. 8 shows a three-dimensional view of a container in the embodiment as a blister, Fig. 9 shows a cross-section through a container designed as a blister, Fig. 10 shows a detail of a container designed as a blister in a three-dimensional view and Figs. 11a and 11b show cross-sections and partial cross-sections of further embodiments of a container according to the invention.

[0034] Figure 1shows a cross-section of a container 1 with two end elements 5, 6, wherein the first end element 5 is designed as a solid body, while the second end element 6 closes off the first receiving space 3 as a thin-walled half-shell in the form of a lid. An opening 7 is provided in the area of ​​the end elements 5, 6, specifically as a recess in the first end element 5, through which opening a catheter can emerge from the first receiving space 3 into the outside space. A groove 13 is provided to hold the catheter, which groove can run in a ring shape further along the container 1 to allow the storage of one or more loops of a catheter. The solid representation of the first end element 5 is given here only as an example to explain the basic function.

[0035] The first end element 5 should form a fluid-tight collecting tray 14 into which a heart pump can be inserted and which can collect fluid during a test operation.

[0036] The second closure element 6 is preferably permanently and tightly connected to the first closure element 5 in the region of the joint 9. With the exception of the opening 7, the connection can advantageously be fluid-tight, but not airtight (since the air from the catheter is intended to escape here). In this example, the joint 9 forms a joining line or an annular joining surface, which lies entirely in one plane.

[0037] The second closure element 6 can be designed as a fluid-tight, curved, flat plastic part, for example, as a rigid film, but it can also have openings and / or one or more optical windows to allow a view into the first receiving space 3. The crucial feature of the second closure element 6 is that it protects the heart pump to be stored in the first receiving space 3 from contact.

[0038] The invention is defined by the claims. Figure 2 shows an illustrative example which only falls within the subject matter of the invention protected if it is implemented in conjunction with all the features of one of the independent claims. Figure 2 a container 1' is shown in which the first closure element 5' as well as the second closure element 6' is designed as a rigid foil in the form of a blister. The first receiving space 3 is, as in the embodiment of the Figure 1formed, and in Figure 2 Also schematically depicted is a heart pump 4 arranged in the first receiving space 3. The heart pump 4 has a rotor 4a with 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 out of the heart pump 4 through a catheter 8, which passes through the opening 7.

[0039] The heart pump 4 is shown in the non-compressed state, in which its radial extension perpendicular to the axial direction indicated by the hub 4c is greater than the extension of the opening 7.

[0040] In Figure 3 is a cut that is Figure 2already designated and indicated by III, with a view of the first end element 5' and the second end element 6' as well as the opening 7, wherein the catheter 8 with the drive shaft 12 is drawn and wherein the outline of the heart pump 4 is drawn in dashed form. 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 can be pulled out of the first receiving space 3 on the catheter 8 only with simultaneous radial compression through the opening 7.

[0041] Figure 4 shows a heart pump device with a heart pump 4, which is based on the Figure 2already described, as well as with a catheter 8 and a drive shaft 12, wherein the drive-side end of the drive shaft 12 is also shown with a magnetic coupling 15, which allows the transmission of a drive movement from a motor 16 to the interior of a container 17 in which the drive shaft 12 is coupled to the magnetic coupling.

[0042] The container 17 also serves as a rinsing device with a plurality of rinsing openings 18, 19, wherein a rinsing liquid, for example saline solution, is introduced into the container 17 through the opening 18 and excess rinsing liquid is removed through the second rinsing opening 19. The rinsing liquid also moves along the catheter 8 in the direction of the pump 4 and is conveyed in the direction of the pump 4 by a helical outer contour of the drive shaft 12, in particular during operation of the rotor, i.e. during rotation of the drive shaft 12. For a test operation, rinsing liquid can thus be supplied through the first rinsing opening 18 and moved through the catheter 8 to the pump 4 while the pump is located in the first receiving space 3, and the pump can then be operated on a trial basis, at least at a reduced speed while being moistened by the rinsing liquid.

[0043] Figure 5shows a top view of a first closure element 5' and the interior of the first receiving space 3, in which a heart pump 4 is arranged. The catheter 8 connected to the heart pump 4 protrudes through the opening 7 and is surrounded by a sheath element 11 outside the receiving space 3 in front of the opening 7. The sheath element 11 is designed, for example, as a flexible plastic torus in the form of a tube section, which can have a predetermined breaking point so that it can be pulled radially away as a peel-away sheath later after the pump 4 has been transferred into an introducer sheath on the patient's body.

[0044] The sheath element 11 can be placed from the outside onto the edge of the opening 7 at the end elements 5', 6' of the first receiving space 3, and then the pump 4 can be withdrawn from the receiving space 3 by means of the catheter in the direction of arrow 20. Due to the given diameter of the opening 7, which is smaller than the pump diameter in the expanded state, the pump 4 is radially compressed in the direction of arrows 21, 22 when retracted into the opening 7 and, in the compressed or at least partially compressed state, is retracted into the sheath element 11. There, it is again protected from contact and contamination and can be removed from the container 1' and moved to an introducer sheath on a patient's body.

[0045] Figure 6shows again in a side view schematically a container 1' with a first receiving space 3 in which a pump 4 is arranged, as well as a lock element 11 arranged in a groove 13 of the container 1', which surrounds a catheter 8.

[0046] Figure 7 shows in a further view in the direction of arrow 23 in Figure 6 seen an external view of the end elements 5', 6' with the opening 7 and a plan view of the lock element 11 in the axial direction as well as a dashed representation of the heart pump 4 located in the first receiving space 3.

[0047] Figure 8shows a perspective view of a first end element 5', which is designed as part of a blister pack, with two recesses, a first of which 24 is delimited by the first end element 5' and forms the lower part of a first receiving space for a heart pump, while the second recess 25 delimits a third receiving space for a handle 26 on the catheter 8. A groove 13 can also be seen, which leads from the first recess 24 to the second recess 25, forms a second receiving space and allows the storage of a catheter, wherein an arc-shaped additional groove 13a is also formed, which allows the storage of loops of the catheter.In addition, grip recesses 27, 28 are provided in the area of ​​the groove 13, which serve on the one hand to stabilize the blister and on the other hand to better grip a catheter located in the groove 13 during removal, as well as to form protrusions of the blister, which can serve as support elements when placed on a flat surface next to the recesses 24, 25.

[0048] A heart pump 4 and the handle part 26 are shown within the container 1" or the end element 5'. However, to complete the container 1", an end element is usually provided on both the first recess 24 and the second recess 25 in order to cover the respective recesses and the components located therein, to protect them from contact, and to fix the components in a shock-proof manner. For this reason, the atraumatic tip of the catheter (so-called pigtail tip) is also fixed in such a way that it does not allow excessive movement of the pump head, but on the other hand, does not hinder withdrawal in the direction of the sheath element 11.

[0049] In Figure 9, a cross-section through the recess 24 is shown by way of example, which is formed in the first closure element 5' designed as part of a blister pack. Within the recess and within the first receiving space 3, a protrusion 29 is formed by a corresponding upward curvature of the first closure element 5', wherein the protrusion 29 has a recess 30 therein, which accommodates the heart pump 4 within the first receiving space 3. This ensures precise, tight, and secure positioning of the heart pump 4 in the first receiving space 3.The first receiving space 3 is also completely covered with a second closing element 6" in the form of a rigid plastic film, wherein the second closing element 6" can be glued, welded or pressed to the first closing element 5' in the region of the contact surface therewith (for example also by means of snap fastener-like connections), so that detachment of the second closing element 6" without destroying the container 1" is not possible or only possible with great difficulty. In this example, the open sides of the first and second closing elements 5', 6" are aligned in the same direction and not, as would also be possible in principle, facing each other.

[0050] The lid shape of the end element covering the second recess 25 can be designed similarly to the shape of the second end element 6".

[0051] When preparing for the implantation of a heart pump, as used in Figure 8As shown, the heart pump 4 is first vented or moistened, and then, using the catheter or handle 26, the heart pump 4 is pulled out of the closed first receiving space 3 through the opening 7 and into a sheath element located outside the first receiving space. In the process, the pump 4 is radially compressed. It is then held securely in the sheath element 11 and protected from contact by the user.

[0052] The pump 4 can be operated on a trial basis before being withdrawn from the first receiving space by moving a rinsing fluid from a rinsing system located in the handle area through rinsing openings via the catheter 8 to the pump and then operating the pump by means of the flexible drive shaft at a speed significantly reduced compared to the operating speed.

[0053] In Figure 10 is an arrangement as in Figure 9shown as a cross-sectional view, is reproduced again in a similar form in three-dimensional representation.

[0054] By means of the invention, the container 1, 1', 1" (or 11"', see Fig. 11b ) in the manner described ensure a high degree of availability and operational reliability as well as sterility of the heart pump during implantation.

[0055] Fig. 11a and 11b show further embodiments of recording rooms. Fig. 11aFirst, a receiving space is shown in which a joint 9 is arranged in the horizontal direction (in the direction of a groove 13 or a corresponding catheter). In addition, a joint 9" is provided perpendicular to this. These joints 9 and 9" can be provided individually or cumulatively. Accordingly, end elements 5" and 6" are provided. On the right-hand side (opposite the opening 7), a further opening 7a" is provided, the diameter of which is significantly larger than the diameter of the opening 7. The size is such that a heart pump can be pulled in in the expanded or only slightly compressed state 7a". However, after the opening 7a" has been closed, the heart pump can then only be pulled out through the opening 7 under compression. In this case, it is possible to provide a cover on the opening 7a" that cannot be removed without causing damage.Alternatively, a non-destructive detachment of the lid can also be provided (e.g., for inspection by the manufacturer). The receiving space 3" or the collecting tray 14" are to be designed according to the embodiments described above. The same applies to the other elements already discussed above (e.g., the channel 13, a catheter 8, a heart pump 4, etc.).

[0056] Fig. 11b shows a further embodiment which differs from that shown in Fig. 11a differs in that only one joint 9‴ is provided. Furthermore, the lower end element (here designated 5‴) is less solid. The collecting tray 14‴ and the receiving space 3‴ are basically as described above, the same applies to the opening 7, the channel 13, and the catheters or heart pumps to be inserted into the receiving space. Fig. 11bA cover is shown (in cross-hatching) which cannot be removed from the end elements 5‴, 6‴ without damaging them. Fig. 11b In the embodiment shown, the heart pump 4 accommodated in the receiving space 3‴ is shown as an example. From this it is clear that the heart pump can be brought into the receiving space through the opening 7a‴, but can only be removed again under compression through the opening 7. The Fig. 11a and 11b The embodiments shown can of course be provided without a second opening or cover, in this case the opening 7 is the only opening of the receiving spaces 3" or 3"'. In Fig. 11b it is at least indicated that the heart pump 4 lies in the receiving space 3‴ in the expanded state, and that this expanded state has a diameter such that the pump can pass through the opening 7a‴ essentially without compression, but can only pass through the opening 7 under compression.

[0057] In some cases, it is then possible that the handle part 26 is only mounted after the heart pump has been inserted into the receiving space 3, 3', 3", 3‴. After the handle has been mounted, the pump can only be removed non-destructively in the intended manner.

[0058] The invention is defined by the claims. The following aspects, which can serve to explain the invention, also form part of the disclosure: One aspect relates to a container for a heart pump device with a first receiving space for a compressible and expandable heart pump, wherein the first receiving space is delimited on several sides, in particular on all sides, by one or more closing elements and is closed off to the outside to prevent contact with the heart pump, wherein the closing elements leave an opening for the passage of a catheter from the outside into the first receiving space, wherein the diameter of the opening is dimensioned such that the heart pump can only pass through it in a state that is at least partially compressed compared to the expanded state.

[0059] A further aspect relates to a container for a heart pump device with a first receiving space for a compressible and expandable heart pump, wherein the first receiving space is delimited on several sides, in particular on all sides, by one or more closing elements and is closed off to the outside to prevent contact with the heart pump, wherein the closing elements leave an opening for the passage of a catheter from the outside into the first receiving space, wherein the diameter of the opening is less than 6 mm, preferably less than 5 mm, particularly preferably less than 4 mm.

[0060] According to one example, the closure elements, in particular the entire container, consist essentially of a flat plastic material, in particular a plastic film.

[0061] According to a further example, the first receiving space is essentially delimited by two half-shell-shaped, joined-together end elements.

[0062] According to another example, the end elements are inseparably connected to one another.

[0063] According to a further example, the opening for the passage of a catheter is formed between two end elements or is open towards the joint between two end elements.

[0064] According to a further example, a first of the end elements is designed as part of a blister which accommodates at least one catheter, in particular additionally further parts of a heart pump device.

[0065] According to a further example, the first closing element forms a collecting tray for liquid in the region of the first receiving space.

[0066] According to another example, the opening consists at least partially of a cylindrically symmetric channel.

[0067] According to another example, the cylindrically symmetrical channel narrows from the inside of the first receiving space to the outside.

[0068] According to a further example, the mouth of the opening to the outside of the closure elements has an edge on which a hollow cylindrical lock element displaceable along the catheter can be supported in the axial direction of the channel.

[0069] According to a further example, a compressible and expandable heart pump is located in the first receiving space and a catheter connected to the heart pump protrudes through the opening from the first receiving space, wherein in particular a sheath element through which the catheter passes is freely displaceable.

[0070] According to a further example, the first receiving space is delimited by at least two end elements joined along a joining line, wherein the joining line runs substantially perpendicular to a passing direction of the heart pump device.

[0071] According to a further example, the first receiving space is delimited by at least two connecting elements joined along a joining line, wherein the joining line runs in a cross section of the receiving space which is larger than the cross section of the opening for the passage of a catheter when removing the heart pump.

[0072] According to another example, the receiving space has more than one opening.

[0073] According to a further example, at least one of the openings is closed by a cover that can be removed in a non-destructive or non-destructive manner when equipped with the heart pump.

[0074] According to a further example, the receiving space is connected in such a way that the heart pump device can be inserted into the receiving space without compression.

[0075] A further aspect relates to a method for operating a heart pump device, in which a heart pump is arranged in the first receiving space of a container as described above and is driven in rotation from the outside by means of a shaft running through a catheter to the heart pump.

[0076] According to one example, a fluid is also conveyed to the heart pump through an opening provided on the catheter along the catheter.

[0077] A further aspect relates to a method for operating a heart pump device, in which a heart pump is arranged in the first receiving space of a container as described above, wherein the heart pump is connected to a catheter which projects through the opening from the first receiving space, wherein by means of the catheter the heart pump is pulled through the opening under radial compression out of the first receiving space and into a lock element which is freely displaceable on the catheter in the axial direction.

Claims

1. A container (1, 1', 1") for a heart pump device (4, 8, 12, 17, 18, 19, 26) with a first receiving chamber (3) for a compressible and expandable heart pump (4), wherein the first receiving chamber (3) is delimited on several sides, in particular on all sides, by one or more end elements (5, 5', 6, 6', 6"), and is closed off from the outside to prevent contact with the heart pump, wherein the end elements (5, 5', 6, 6', 6") leave an opening (7) for a catheter (8) to pass through into the first receiving chamber (3) from the outside, the diameter of the opening (7) is dimensioned such that the heart pump can pass through it exclusively in an at least partially compressed state with respect to the expanded state, characterised in that the first receiving chamber (3) is delimited by at least two end elements joined along a joining line, wherien the joining line runs essentially perpendicular to a passing direction of a heart pump device.

2. A container (1, 1', 1") for a heart pump device (4, 8, 12, 17, 18, 19, 26) with a first receiving chamber (3) for a compressible and expandable heart pump (4), wherein the first receiving chamber (3) is delimited on several sides, in particular on all sides, by one or more end elements (5, 5', 6, 6', 6"), and is closed off from the outside to prevent contact with the heart pump (4), wherein the end elements (5, 5', 6, 6', 6") leave an opening (7) for a catheter (8) to pass through into the first receiving chamber (3) from the outside, wherein the diameter of the opening is smaller than 6 mm, preferably smaller than 5 mm, particularly preferably smaller than 4 mm, characterised in that the first receiving chamber (3) is delimited by at least two end elements joined along a joining line, wherein the joining line runs essentially perpendicular to a passing direction of a heart pump device.

3. The container of claim 1 or 2, characterised in that at least the end elements (5, 5', 6, 6', 6"), in particular the entire container (1, 1', 1"), consist essentially of a flat plastic material, in particular a plastic film.

4. The container of claim 1, 2 or 3, characterised in that the first receiving chamber (3) is essentially delimited by two half shell-shaped, joined end elements (5, 5', 6, 6', 6").

5. The container of claim 1 or one of the following, characterised in that the end elements (5, 5', 6, 6', 6") are undetachably connected to one another, and / or characterised in that the opening (7) is formed for a catheter (8) to pass between two end elements (5, 5', 6, 6', 6") or is open towards the joint (9) between two end elements, and / or characterised in that a first of the end elements (5, 5') is designed as part of a blister which accommodates at least one catheter (8), in particular additionally further parts of a heart pump device.

6. The container of claim 5, characterised in that the first end element (5, 5') forms a collecting tray (14) for liquid in the region of the first receiving chamber.

7. The container of claim 1 or one of the following, characterised in that the opening (7) consists at least partially of a cylindrically symmetrical channel.

8. The container of claim 7, characterised in that the cylindrically symmetrical channel narrows outwardly from the interior of the first receiving chamber (3).

9. The container of claim 8, characterised in that the mouth of the opening (7) toward the outside of the end elements (5, 5', 6, 6', 6") has an edge on which a hollow cylindrical lock element (11), which is displaceable along the catheter (8), can be supported in the axial direction of the channel.

10. The container of one of claims 1 to 9 with a heart pump device, wherein a compressible and expandable heart pump (4) is located in the first receiving chamber (3) and a catheter (8) connected to the heart pump projects out of the first receiving chamber (3) through the opening (7), characterised in that a port element (11), which is freely displaceable along the catheter, is provided on the catheter, and / or characterised in that the first receiving chamber is delimited by at least two connecting elements joined along a joining line, the joining line extending into a cross-section of the receiving chamber which is larger than the cross-section of the opening through which the catheter passes when removing the heart pump, and / or characterised in that the receiving chamber has more than one opening.

11. The container of claim 10, characterised in that at least one of the openings is closed by a non-destructive or non-destructively removable joined cover when fitted with the heart pump.

12. The container of one of the preceding claims, characterised in that the receiving chamber is arranged in such a way that the heart pump device can be introduced into the receiving chamber without compression.

13. A method for operating a heart pump device, in which a heart pump is arranged in the first receiving chamber (3) of the container (1, 1', 1") of one of claims 1 to 12, and is rotationally driven from the outside by a shaft (12) through a catheter (8) which extends to the heart pump (4).

14. The method of claim 13, characterised in that, additionally, a liquid is delivered along the catheter to the heart pump (4) through an opening (18, 19) on the catheter (8).

15. A method for operating a heart pump device, in which a heart pump (4) is arranged in the first receiving chamber (3) of the container (1, 1', 1") of one of claims 1 to 12, the heart pump (4) being connected to a catheter (8) which projects out of the first receiving chamber (3) through the opening (7), characterised in that the heart pump (4) is pulled out of the first receiving chamber (3) by the catheter (8) through the opening under radial compression and into a port element (11) which is freely displaceable on the catheter (8) in the axial direction.