HK1237286B

HK1237286B - Container for a heart pump device and method for operating a heart pump device

Info

Publication number: HK1237286B
Application number: HK17110993.7A
Authority: HK
Inventors: Röhn Daniel; Schumacher Jörg
Original assignee: Ecp Entwicklungsgesellschaft Mbh
Priority date: 2015-01-13
Filing date: 2016-01-12
Publication date: 2021-08-13

Abstract

The invention relates to a container (1, 1', 1") for a heart pump device (4, 8, 12, 17, 18, 19, 26) having a first accommodating space (3) for a compressible and expandable heart pump (4), wherein the first accommodating space (3) is bounded on a plurality of sides, in particular on all sides, by one or more closure elements (5, 5', 6, 6', 6") and is externally closed in order to prevent touching of the heart pump, wherein the closure elements (5, 5', 6, 6', 6") leave open an opening (7) for the passage of a catheter (8) from outside into the first accommodating space (3), wherein the diameter of the opening (7) is dimensioned in such a way that the heart pump (4) can pass through the opening only in a state in which the heart pump is at least partially compressed in comparison with the expanded state. For implantation, the heart pump can first be operated in the container (1, 1', 1") for test purposes while a rinsing liquid is supplied and can then be pulled into a lock element (11) through the opening (7) while being compressed.

Description

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

Technical Field

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

In recent years, the use of mechanical heart pumps has increased significantly to assist or replace a patient's heart activity. Typically, these pumps operate inside or outside the patient's body. However, in many cases, it is desirable to implant these pumps in the patient's body.

In this case, pumps that can be compressed and expanded to a large extent, allowing them to be implanted in a small size and then expanded in the patient's body, are already known. A special type of such pump includes a drivable rotor that transports blood axially, wherein the rotor with the pump housing can preferably be introduced into the region of the ventricles or the aorta and operated therein. Delivery of such a pump into the patient's body can be achieved, for example, through blood vessels to the heart.

Naturally, reliable sterility is essential for the manufacture, transportation, and preparation for implantation of such heart pump systems. Certain components of the heart pump system can be dangerous if they are not expertly and carefully removed 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 severely impair the function of such pumps, and in some cases, even improper hand contact can cause serious damage.

Summary of the Invention

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.

According to the present invention, this object is achieved by the technical features of the present invention. The design is specified in the embodiment.

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 accessed, wherein the closing elements leave an opening for allowing a catheter to pass from the outside into the first receiving space, wherein the diameter of the opening is sized such that the heart pump can pass completely through the device in a condition at least partially compressed compared to an expanded condition.

Thus, the heart pump device comprises 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 further components as appropriate.

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 comprise openings and for one of the closing elements to be constructed, for example, in the form of a grid. 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 in order to allow observation of the interior of the first receiving space.

The opening of the catheter channel is used to guide a catheter directly connected to the heart pump, wherein advantageously, the entire length of the catheter remains free in the second receiving space of the container beyond the first receiving space. Finally, a handle provided on the catheter for manipulation can remain free in the third receiving space of the container and can be similarly surrounded there by the container wall, for example, on all sides.

The diameter of the opening should be such that the pump cannot be removed through the opening in the expanded state (the opening can initially be larger when packaged and only 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, by a drive shaft passing through a catheter, in order to test whether the heart pump is operational. 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 by being pulled out by the catheter. The decisive factor 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 pulled into a sheath applied outside the opening area of the first receiving space, said sheath accommodating the pump in at least a partially compressed state. It is conceivable that the diameter of the opening is less than 6 mm, preferably less than 5 mm, and in particular less than 4 mm.

According to one advantageous embodiment of the container according to the invention, at least the closing element, in particular the entire container, is conceived to consist primarily of a plastic material, in particular a plastic foil. The container can, for example, be manufactured as a so-called blister of a flexible, rigid plastic foil. However, thicker plastic materials can be provided, or a portion of the container can consist of a plastic element manufactured by injection molding. If the container consists primarily of a blister, it can be formed from the plastic foil by deep drawing or pressing.

A further advantageous 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 dividing 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 forming the cover body in this way can be joined to the first half-shell by pressing, gluing, 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 it is implanted and cannot be removed in between these two time points.

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

The two half-shells can be placed opposite each other with the openings facing each other or with the openings aligned accordingly.

Furthermore, it is advantageously conceivable that the opening is formed so as to allow the catheter to pass between the two closure elements, or the opening is directed toward the joint between the two closure 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 closure elements are joined together to define the first receiving space.

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 to receive at least one catheter and, in particular, additionally, further parts of the heart pump device.

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. Furthermore, such 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 that the fluid accumulates around the pump to ensure wetting of the heart pump, and, on the other hand, prevents the fluid from escaping the first receiving space in an uncontrolled manner.

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

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 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.

Furthermore, it can also be advantageous if the projection to the outside of the closure element and to the first receiving space comprises an edge on which a hollow cylindrical sheath element is provided which is movable along the conduit and can be supported in the axial direction of the channel.

A sheath in the form of a hollow cylindrical component, in particular a peel-off sheath that can be destructively removed radially, for example by tearing off the opening, can be slipped over a catheter, i.e., the catheter can be pulled into the sheath, and is typically already part of a heart pump device located in a container. Such a sheath element can be pressed against the edge of an opening in a closure element from the outside of a first receiving space, so that the heart pump can be pulled from the first receiving space into the sheath element through the opening using a catheter passing through the sheath element. The heart pump is thus at least partially radially compressed within the opening of the receiving space and, in particular, further radially compressed upon 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 already compressed within the opening of the receiving space, thereby reducing further compression upon pulling into the sheath. The edge of the opening can advantageously be an annular surface extending perpendicularly to the longitudinal axis of the opening.

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 and placed in the sheath element and then introduced into the patient, for example via a traction wire. For this purpose, a separate lumen is provided for the traction wire.

In addition to the container of the above-mentioned type, 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 protrudes 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 movably manner.

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

To this end, it is also advantageous to allow the fluid to be delivered to the heart pump along the catheter through an opening provided in the catheter. This ensures that the heart pump is tested in real-world contact with the fluid. The heart pump device can also be filled with fluid as much as possible, thereby significantly reducing the introduction of air during implantation. Any biocompatible flushing fluid, such as saline solution, glucose solution, or the like, can be used as the fluid delivered to the heart pump.

The present invention also relates to a method for operating a heart pump device, wherein the heart pump is arranged in a first receiving space of a container according to the present invention. The heart pump is connected to a catheter, which extends out of the first receiving space through an opening. The method is characterized in that the heart pump is pulled out of the first receiving space through the opening by the catheter in a radially compressed state and drawn into a sheath element that is freely movable on the catheter in the axial direction (i.e., in the longitudinal direction of the catheter).

The subject matter of the present invention particularly includes one or more closure elements that delimit a receiving space for a compressible and expandable heart pump. A "receiving space" is preferably understood to mean the smallest complete space that completely surrounds the heart pump head (e.g., the further portion connected to the removal opening 7 (see, e.g., Figures 1 to 3 ) is not included in this context). This is to prevent access to the heart pump, i.e., to protect the heart pump from being touched in the receiving space. The closure element leaves at least one free opening for the passage of a catheter, wherein the diameter of the opening is dimensioned such that the heart pump can only be passed through in a state that is at least partially compressed compared to its expanded state. Therefore, "passing through a catheter" should be understood as allowing the corresponding catheter to pass through the opening, and preferably not in terms of a specific passage direction. Reference is made to "one or more closure elements" in the present invention. In particular, in the case of "a plurality of closure elements," these closure elements can have different designs. This means that the closure elements forming the receiving space can be connected to each other in different ways. Thus, the connection can be achieved, for example, by a screw connection. This connection is preferably such that it cannot be released without destruction, but can alternatively be manufactured in a destruction-proof manner. Thus, the expanded pump can be accommodated in the receiving space by having the closure elements connected together "around the pump" and subsequently unable to be separated from each other in a damage-proof manner. In this case, the joining lines connecting the various closure elements can be arranged outside the opening of the receiving space along the longitudinal direction of the catheter or perpendicular to this direction. The details of this aspect are described in detail below.

In one embodiment, the first receiving space is delimited by at least two closure elements connected along a joint line, wherein the cross-section of the joint 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", while subsequent extraction of the heart pump (pump head) is only possible in the compressed state.

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, subsequent removal of the pump head (preferably arranged at the opposite end of the receiving space) is only possible in the compressed state (see, for example, FIG. 11 a ).

A further development envisages that at least one opening of the receiving space is closed by a cover that engages the opening of the receiving space in a manner that allows for removal without destruction or after destruction. Thus, for example, as described above, the pump can first be introduced into the receiving space through a larger opening (without forcing the heart pump to compress). It can then be closed with the cover in such a way that it cannot be released in a destructive manner. In this way, it is ensured that the heart pump cannot be removed from the receiving space by the user without being compressed.

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

The present invention is illustrated below by way of example in the accompanying drawings and described below.

FIG1 is a schematic cross-sectional view of a container according to the present invention,

FIG2 is a cross-sectional view of a container with a heart pump according to the present invention,

FIG3 is another cross-sectional view of the container,

Figure 4 shows a heart pump with a catheter.

FIG5 is a front view of a container with a heart pump,

FIG6 is a cross-sectional view of a container with a heart pump and with a sheath element,

FIG7 is another cross-sectional view through the container and the sheath element,

FIG8 is a three-dimensional view of the container in an embodiment as a blister,

FIG9 is a cross-sectional view through a container designed as a blister,

FIG10 is a three-dimensional view of a detail of a container designed as a blister, and

11a and 11b are cross-sectional views or partial cross-sectional views of a container according to another embodiment of the present invention.

DETAILED DESCRIPTION

The cross-sectional view of FIG1 shows a container 1 having two closure elements 5 and 6, wherein the first closure element 5 is a solid body, and the second closure element 6 is a thin-walled half-shell, shaped like a lid, covering the first receiving space 3. An opening 7 is provided in the region of the closure elements 5 and 6, and in particular in the first closure element 5 as a recess through which a conduit can protrude from the first receiving space 3 into the exterior. A channel 13 extending around one end of the container 1 can be provided, which can be used to receive a conduit, thereby allowing one or more conduit loops to be installed. This solid representation of the first closure element 5 is provided merely as an example to explain its basic function.

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

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

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

As shown in FIG2 , the first closure element 5′ in the container 1′ is designed as a blister-shaped rigid foil, just like the second closure element 6′. The first receiving space 3 is shaped like the embodiment in FIG1 , and the heart pump 4 arranged in the first receiving space 3 is schematically shown in FIG2 . The heart pump 4 includes a rotor 4a having a spiral 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 via a catheter 8 that passes through an opening 7.

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 .

The part already shown and indicated at III in FIG2 is also shown in FIG3 , showing the first closure element 5 ′ and the second closure element 6 ′ and the opening 7 , into which the catheter 8 with the drive shaft 12 is drawn, and wherein the outline of the heart pump 4 is drawn in dashed lines. As can be seen in FIG3 , the diameter of the heart pump 4 is greater than the clear width of the opening 7 , so that the heart pump 4 on the catheter 8 can only be pulled out of the opening 7 of the first receiving space 3 while being radially compressed.

FIG4 shows a heart pump device having the heart pump 4 already described in FIG2 , and a catheter 8 with a drive shaft 12 , wherein the drive side end of the drive shaft 12 is also shown having a magnetic coupling 15 , which allows the drive movement to be transmitted from the electric motor 16 into the container 17 , wherein the drive shaft 12 is coupled to the magnetic coupling.

The container 17 also has a plurality of flushing openings 18 and 19, which 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 conduit 8 toward 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 toward the pump 4 by the helical outer profile of the drive shaft 12. Thus, for a test operation, the flushing fluid can be introduced into the first flushing opening 18, allowed to move through the conduit 8 toward the pump 4 located in the first receiving space 3, and then the pump can be tested, at least at a reduced speed while being wetted with the flushing fluid.

FIG5 shows a front view of the first closure element 5 ′ and the interior of the first receiving space 3 in which the heart pump 4 is arranged. The catheter 8 connected to the heart pump 4 protrudes from 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, in the case of a peel-off sheath, it can be radially removed at a later stage after the pump 4 has been placed in the introduction sheath on the patient.

The sheath element 11 can be pulled from the outside onto the edge of the opening 7 in the closure elements 5 ', 6 ' of the first receiving space 3, and the pump 4 can be pulled out of the receiving space 3 via 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 drawn into the opening 7 in the direction of the arrows 21, 22 in a compressed or at least partially compressed state and drawn 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 an introduction sheath on the patient's body.

FIG. 6 again schematically shows a side view of the container 1 ′ with the first receiving space 3 , 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 .

Figure 7 shows an external view of the closing elements 5', 6' with the opening 7 and a main view of the sheath element 11 in the axial direction according to another perspective seen in the direction of the arrow 23 in Figure 6, and the dotted line represents the heart pump 4 located in the first receiving space 3.

FIG8 shows a perspective view of a first closure element 5', designed as part of a blister, having two recesses. A first recess 24, delimited by the first closure element 5', forms the lower portion of a first receiving space for a heart pump, while a second recess 25 delimits a third receiving space for a handle on the catheter 8. Furthermore, a channel 13 can be seen, which leads from the first recess 24 to the second recess 25, forming a second receiving space and allowing for the placement of the catheter. An additional arched channel 13a is also formed, which allows for the placement of a catheter loop. Furthermore, handle recesses 27 and 28 are provided in the region of channel 13. These serve, on the one hand, to stabilize the blister and, on the other hand, to improve the handling of the handle when removing the catheter located within channel 13. They also form a protrusion on the blister, thus serving as a support element when placed on a horizontal surface adjacent to recesses 24 and 25.

The heart pump 4 and the handle portion 26 are shown inside the container 1' or the closure element 5'. However, usually, the closure element is arranged on the first groove 24 and the second groove 25 to cover the corresponding grooves and the components located therein, protecting them from contact, and serving as a fixing element to maintain the fixation 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, withdrawal in the direction of the sheath element 11 is not restricted.

FIG9 illustrates a cross-section through the recess 24 formed in the first closure element 5', which is formed as part of the blister. A protrusion 29, formed by a suitable protruding dome of the closure element 5', is located within the recess and within the first receiving space 3. The protrusion 29 includes a recess 30 for accommodating the heart pump 4 within the first receiving space 3. This ensures that the heart pump 4 is positioned accurately, securely, and securely within the first receiving space 3. Furthermore, the first receiving space 3 is completely covered by a second closure element 6" in the form of a hard plastic foil. The contact surface area of the second closure element 6" with the first closure element 5' can be glued, welded, or crimped (e.g., also by a key-like connection), making it 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" face the same direction, rather than opposite directions, although opposite directions are also possible.

The shape of the cover of the closing element of the second groove 25 can be designed to be similar to the shape of the second closing element 6 ′.

In preparation for implantation of the heart pump, as shown in FIG8 , the heart pump 4 is first vented and moistened, and then the heart pump 4 is pulled out of the closed first receiving space 3 through the opening 7 using a catheter or handle 26 and pulled into the sheath element located outside the first receiving space. This radially compresses the pump 4. Thereafter, it is securely held in the sheath element 11 and protected from contact by the user.

Before being pulled out of the first receiving space, the pump 4 can be tested by letting the irrigation fluid flow from the irrigation system located in the area of the handle through the irrigation opening and 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.

In FIG. 10 , a structure similar to that shown in cross section in FIG. 9 is shown in three dimensions.

The container 1 , 1 ′, 1 ″ (or 11 ″′, see FIG. 11 b ) can ensure high availability and operational reliability as well as sterility of the heart pump during implantation by means of the invention and in the manner described.

Figures 11a and 11b show further embodiments of the receiving space. In Figure 11a, the receiving space is first shown, with the upper connection point 9 arranged horizontally (in the direction of the channel 13 or the corresponding conduit). An additional connection point 9' is arranged perpendicular to this. The connection points 9 and 9' can be provided separately or simultaneously. Closing elements 5" and 6" are provided accordingly. On the right side (opposite the opening 7), a further opening 7a"' is provided, the diameter of which is much larger than that of the opening 7. Its size allows the heart pump to be pulled in through this opening in the 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 the compressed state. For this case, a cover that cannot be released in a non-destructive manner can be provided on the opening 7a". Alternatively, a cover that can be removed in a non-destructive manner (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 other elements already discussed (such as the channel 13, the conduit 8, the heart pump 4, etc.).

FIG11 b shows a further embodiment, which differs from FIG11 a in that there is only one joint 9". In addition, the lower closure element (here indicated by 5') is designed with a reduced solid part. The receiving basin 14'" or the receiving space 3'" is then essentially as described above, with the same opening 7, the channel 13 and the catheter or heart pump to be introduced into the receiving space. FIG11 b shows a cover (cross-hatched part) which cannot be released from the closure 5", 6'" in a way that does not prevent damage. In the embodiment shown in FIG11 b, a heart pump 4 is illustrated which is already accommodated in the 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 removed through the opening 7 in a compressed state. The embodiment shown in Figures 11a and 11b can of course also be without a second opening or a cover, in which case the opening 7 is the only opening in the receiving spaces 3' and 3'". In Figure 11b, at least the heart pump 4 is indicated as being placed in the receiving space in an expanded state and having a diameter such that the pump can pass through the opening 7a'' essentially without compression, but can only pass through the opening 7 when compressed.

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 without causing damage in the manner described above.

Technical Field

Background Art

Summary of the Invention

BRIEF DESCRIPTION OF THE DRAWINGS

FIG3 is another cross-sectional view of the container,

Figure 4 shows a heart pump with a catheter.

FIG5 is a front view of a container with a heart pump,

FIG9 is a cross-sectional view through a container designed as a blister,

DETAILED DESCRIPTION

Technical Field

Background Art

Summary of the Invention

BRIEF DESCRIPTION OF THE DRAWINGS

FIG3 is another cross-sectional view of the container,

Figure 4 shows a heart pump with a catheter.

FIG5 is a front view of a container with a heart pump,

FIG9 is a cross-sectional view through a container designed as a blister,

DETAILED DESCRIPTION

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

Technical Field

Background Art

Summary of the Invention

BRIEF DESCRIPTION OF THE DRAWINGS

FIG3 is another cross-sectional view of the container,

Figure 4 shows a heart pump with a catheter.

FIG5 is a front view of a container with a heart pump,

FIG9 is a cross-sectional view through a container designed as a blister,

DETAILED DESCRIPTION

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 defined on several sides by at least two semi-shell-shaped closure elements (5, 5', 6, 6', 6”) joined together and closed to the outside to prevent contact with the heart pump, wherein the closure elements (5, 5', 6, 6', 6”) leave an opening (7) for a catheter (8) to pass through 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 under conditions that are at least partially compressed compared to expanded conditions.

2. The container according to claim 1, wherein the plurality of sides includes all sides.

3. 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 defined on several sides by at least two semi-shell-shaped closure elements (5, 5', 6, 6', 6”) joined together and closed to the outside to prevent contact with the heart pump, wherein the closure elements (5, 5', 6, 6', 6”) leave an opening (7) for a catheter (8) to enter the first receiving space (3) from the outside, wherein the diameter of the opening is less than 6 mm.

4. The container according to claim 3, wherein the plurality of sides includes all sides.

5. The container according to claim 3, wherein the diameter of the opening is less than 5 mm.

6. The container according to claim 3, wherein the diameter of the opening is less than 4 mm.

7. The container according to any one of claims 1 to 6, characterized in that the closing element (5,5',6,6',6") is made of a flat plastic material.

8. The container according to any one of claims 1 to 6, characterized in that the container (1,1',1") is made of a flat plastic material.

9. The container according to claim 7, wherein the flat plastic material is a plastic foil.

10. The container according to claim 8, wherein the flat plastic material is a plastic foil.

11. The container according to any one of claims 1 to 6, characterized in that the closing elements (5,5',6,6',6") are indivisibly connected to each other.

12. The container according to any one of claims 1 to 6, 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 the joint (9) between the two closing elements.

13. The container according to any one of claims 1 to 6, characterized in that the first closing element (5, 5') is designed as part of a blister, the blister at least receiving the conduit (8).

14. The container according to claim 13, wherein the blister also accommodates other additional components of the heart pump device.

15. The container according to claim 13, wherein the first receiving space (3) forms a fluid-receiving shell (14) in the region of the first closing element (5, 5').

16. The container according to any one of claims 1 to 6, wherein the opening (7) comprises at least a portion of a cylindrical symmetrical channel.

17. The container according to claim 16, wherein the cylindrical symmetrical channel narrows from the inside to the outside of the first receiving space.

18. The container according to claim 17, characterized in that the opening has an extension on the outside of the closing element (5, 5', 6, 6', 6"), the extension including an edge on which a hollow cylindrical sheath element (11) is provided, the hollow cylindrical sheath element (11) being movable along the conduit (8) and being supported in the axial direction of the channel.

19. The container according to any one of claims 1 to 6, having a heart pump device, wherein a compressible and expandable heart pump (4) is located in the first receiving space (3), and wherein a conduit (8) connected to the heart pump extends outward from the first receiving space (3) through the opening (7), wherein a sheath element (11) through which the conduit passes is disposed on the conduit in a freely movable manner.

20. The container according to any one of claims 1 to 6, characterized in that the first receiving space (3) is defined by at least two closure elements joined along a joint line, wherein the joint line extends substantially perpendicular to the through direction of the heart pump device.

21. The container according to any one of claims 1 to 6, characterized in that the first receiving space (3) is defined by at least two closing elements joined along a junction line, wherein the cross-section through which the junction line passes in the first receiving space (3) is larger than the cross-section of the opening through which the catheter passes when the heart pump is removed.

22. The container according to any one of claims 1 to 6, wherein the first receiving space (3) comprises more than one opening.

23. The container according to claim 22, characterized in that, when equipped with a heart pump, at least one of the openings is closed by a cover, the cover being engaged in a manner that allows for removal by means of destruction or non-destruction.

24. The container according to any one of claims 1 to 6, characterized in that the first receiving space (3) is configured such that the heart pump device can be introduced into the first receiving space (3) without compression.

25. A method for operating a heart pump device, wherein the heart pump is arranged in a first receiving space (3) of a container (1,1',1") according to any one of claims 1 to 24 and is externally driven to rotate by a shaft (12) of the heart pump (4) through a conduit (8).

26. The method according to claim 25, wherein the flushing fluid is delivered to the heart pump (4) along the conduit (8) through openings (18, 19) provided on the conduit (8).

27. A method for operating a heart pump device, wherein the heart pump (4) is arranged in a first receiving space (3) of a container (1,1',1”) according to any one of claims 1 to 24, wherein the heart pump (4) is connected to a conduit (8) protruding from the first receiving space (3) through the opening (7), characterized in that the heart pump (4) is pulled out from the first receiving space (3) through the opening by the conduit (8) under radial compression conditions and is dragged into a sheath element (11) that is axially displaceable on the conduit (8).