Kit for producing and extruding bone cement, and method

Abstract

To provide a kit for producing and extruding bone cement, use of a kit, and a method for using the kit.SOLUTION: A kit 1 for producing and extruding bone cement comprises a first container 12 which contains a first component for producing bone cement, a second container 70 which contains a second component for producing bone cement, a mixing apparatus for manually mixing the first component and the second component in the first container for the purpose of producing bone cement, and an extruding apparatus 10 for manually extruding the produced bone cement from the first container. In this way, all materials and apparatuses required for the production and extrusion of bone cement are provided together.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention relates to a kit for manufacturing and extruding bone cement, the use of the kit, and a method of using the kit.

[0002] Bone cement is typically manufactured by mixing a powder with a liquid. For example, polymethyl methacrylate (PMMA) bone cement, which consists of a liquid monomer component and a powder component, is known. The monomer component generally contains monomer methyl methacrylate and, in particular, an activator dissolved therein, such as N,N-dimethyl-p-toluidine. The powder component, also referred to as bone cement powder, is one or more polymers produced by polymerization, preferably suspension polymerization, based on methyl methacrylate and a comonomer such as styrene, methyl acrylate or a similar monomer, and particularly includes a radiopaque agent and / or a dibenzoyl peroxide initiator. When the powder component is mixed with the monomer component, an actual bone cement, a plastically deformable paste (also referred to as bone cement paste), is produced, for example, by the polymer of the powder component that swells in methyl methacrylate. When the powder component is mixed with the monomer component, an activator, such as N,N-dimethyl-p-toluidine, reacts with dibenzoyl peroxide to form radicals. The formed radicals can initiate the radical polymerization of methyl methacrylate. As the polymerization of methyl methacrylate proceeds, the viscosity of the cement can continue to increase until the cement solidifies.

[0003] PMMA bone cement is mainly used to permanently fix intra-articular prostheses to bone. Generally, in order to fix intra-articular prostheses, a cement amount of 50 g to 125 g or more is used. The bone cement is required during the patient's surgery and should be provided quickly. This is the main application field of the present invention. However, the application field of the present invention does not provide a minimum amount of bone cement in the range of less than 10 g and / or 10 ml for vertebral body stabilization, as in the case of kyphoplasty and vertebroplasty, for example. Such a minimum amount can be extruded using simple technical means.

[0004] The bone cement of polymethyl methacrylate can be mixed by mixing the cement powder with the monomer liquid using a spatula in a suitable mixing beaker. During the process, air bubbles may be mixed into the bone cement, which may have an adverse effect on the mechanical properties of the hardened bone cement. Other drawbacks are the need to measure the amount manually and that proper mixing is not always guaranteed. The features, embodiments and definitions referred to in this specification can be combined with the features of the present invention as desired.

[0005] Vacuum cementing systems are known for preventing the entrainment of air into bone cement. For example, U.S. Patent No. 6,033,105 (A), U.S. Patent No. 5,624,184 (A), U.S. Patent No. 4,671,263 (A), U.S. Patent No. 4,973,168 (A), U.S. Patent No. 5,100,241 (A), International Publication No. 99 / 67015 (A1), European Patent No. 1,020,167 (A2), U.S. Patent No. 5,586,821 (A), European Patent No. 1,016,452 (A2), German Patent Application Publication No. 3,640,279 (A1), International Publication No. 94 / 26403 (A1), European Patent No. 1,005,901 (A2), European Patent No. 1,886,647 (A1), U.S. Patent No. 5,344,232 (A) may be mentioned. Further developments in cementing technology are represented by cementing systems in which both the cement powder and the monomer liquid are already packaged in separate compartments and are mixed with each other immediately prior to cement application in the cementing system. Such sealed fully pre-packaged mixing systems or similar systems are described, inter alia, in the documents European Patent No. 0,380,867 (B1), European Patent No. 0,796,653 (B1), European Patent No. 0,692,229 (A1), German Patent Application Publication No. 10 2009 031 178 (B3), U.S. Patent No. 5,997,544 (A), U.S. Patent No. 6,709,149 (B1), International Publication No. 00 / 35506 (A1) and European Patent No. 0,796,653 (A2). Currently, for extrusion, it is necessary to use an external device such as a cartridge press (cement gun). Since such devices are expensive and complex, they are provided separately and can then be used with the corresponding mixing system. Subsequently, cleaning and sterilization are required to enable the device to be reused.

[0006] Mixing devices in which an external device for extruding bone cement is used are disclosed in WO 94 / 16951 (A1), EP 1 741 413 (B1), EP 3 054 880 (B1), and DE 197 18 648 (A1). Mixing devices or similar systems in which a vacuum is applied to enable the transfer or mixing of components or bone cement are known from US 8 662 736 (B2) and EP 3 093 067 (B1). EP 2 393 456 (B1) describes a mixing device in which a liquid is pressed into a powder by overpressure.

[0007] Manually operated discharge devices are based, for example, on a manually movable lever system connected to a cement cartridge that drives a push rod or toothed bar. By repeatedly tilting the lever, the push rod or toothed bar is moved in the direction of the discharge plunger of the cartridge, and the discharge plunger moves in the direction of the cartridge head, thereby extruding the polymethylmethacrylate bone cement from the cartridge through a discharge tube attached to its front face. Such or similar discharge devices are disclosed in US 589 344 (A), US 5 638 997 (A), and WO 94 / 16951 (A).

[0008] Screw systems are generally used to remove small amounts of cement of up to approximately 10 g of bone cement and are used to stabilize fractured vertebral bodies. These screw systems known to date have only a low mechanical load-bearing capacity and are not suitable for discharging larger amounts of PMMA bone cement of at least 50 g. Examples of such discharge devices or similar devices are the publications of US 6 676 663 (B2), US 2012 / 224 452 (A1), CN 218 22 029 (U), and CN 213 19 002 (U).

[0009] The object of the present invention is to provide a simple and cost-effective solution for manufacturing and extruding bone cement.

[0010] This object is achieved by a kit for manufacturing and extruding the bone cement according to claim 1, the use of the kit, and the method according to the independent claims.

[0011] To achieve this object, a kit for manufacturing and extruding bone cement, comprising: - a first container containing a first component for manufacturing bone cement; - a second container containing a second component for manufacturing bone cement; - a mixing device for manually mixing the first component and the second component in the first container for manufacturing bone cement; - an extrusion device for manually extruding the manufactured bone cement from the first container, is used.

[0012] The kit typically includes all the materials and instruments necessary for manufacturing and extrusion, and can thus also be referred to as a fully pre-packaged mixing system or "treatment pack". The kit also includes an extrusion device. Thus, the kit is suitable not only for manufacturing bone cement but also for extruding it at the site of use. Since conventional extrusion devices are expensive and technically complex, they are generally not incorporated into the kit.

[0013] The kit can be used directly by a medical user, such as a surgeon, during surgery. In one embodiment, the kit is designed such that no additional devices or items are required to prepare and extrude the bone cement. In another embodiment, the kit is designed to be connectable to a vacuum source so that a vacuum can be applied to the first container for mixing the bone cement.

[0014] In particular, the bone cement can be prepared by mixing a first component and a second component. However, it cannot be denied that there are one or more additional substances in the production of bone cement. In particular, the first component includes, for example, a powder containing one or more polymers, or is a powder containing one or more polymers. In particular, the second component is a liquid containing, for example, a monomer solution, or is a monomer solution.

[0015] The first container contains the first component and encloses a cavity into which the second component can be introduced. The first container may further comprise additional components such as one or more connection regions as described below.

[0016] In particular, the first container is a sealed container. In particular, the first container is designed as a cartridge. The cartridge particularly comprises a cylindrical, for example circular cylindrical wall. The extrusion device can be designed such that a plunger can be pushed into the cartridge along the longitudinal direction of the cartridge from the first side in order to displace the bone cement accommodated in the cartridge. In this way, the bone cement can be extruded to the second side on the opposite side.

[0017] In particular, the second container is a sealed container. For example, the second container can be designed as a pouch or an ampoule. There may be two or more second containers.

[0018] In particular, the extrusion device can be operated manually. This means that in particular a manual force can be applied to the first container from the outside, enabling the bone cement to be mechanically extruded. In particular, the extrusion device is designed to be mechanically connected to the first container. Thus, for example, the extrusion device can be connected to the first container only once the mixing of the bone cement in the first container is complete. The connection between the extrusion device and the first container can be reversible, i.e., manually removable. Preferably, the extrusion device comprises a connection area, the first container comprises a connection area, and the two connection areas can be manually, in particular reversibly, connected to each other. In the connected state, the bone cement can be extruded from the first container using the extrusion device. The connection area can be designed, for example, as a screw, as a clamp, or preferably as a bayonet lock. Thus, both connection areas comprise corresponding connection elements, for example in the form of pins. The connection element of the first container can be arranged inside and / or project inside the wall of the first container. This enables the bone cement to be extruded a few seconds after the completion of mixing. This can save valuable surgical time. In addition, the user can start the cementing more quickly, so that the time remaining for cementing until the end of the processing stage is longer.

[0019] The mixing device is in particular designed to move a mixing element inside the first container in order to mix two components. For example, the mixing device comprises a handle for moving the mixing element inside the first container. The handle and the mixing element are typically connected via a central and / or axial rod. The movement is carried out, for example, up and down along the longitudinal axis of the first container and / or by rotating around the longitudinal axis. The mixing element can be a porous disk that displaces a part of the mass inside the first container and passes another part of the mass when moved in order to achieve mixing. The outer contour of the disk can substantially or completely correspond to the inner contour of the first container, so that the disk can be moved like a cylinder in a plunger.

[0020] Preferably, the mixing device comprises a connection area, the first container comprises a connection area, and the two connection areas can be manually, and in particular reversibly, connected to each other. In the connected state, the components in the first container can be mixed together by the mixing device to produce bone cement.

[0021] In one embodiment, the kit further comprises at least one discharge tube for discharging the prepared bone cement, a pressurizer such as a knee pressurizer and / or a lumbar pressurizer, a snorkel such as a knee snorkel and / or a flat snorkel, and / or a vacuum hose for connecting the first container to an external vacuum source. The pressurizer is a connector made of a flexible material such as rubber that can push the bone cement from the first container into body tissue such as cancellous bone. The snorkel is a tubular body for transferring the bone cement to a target location, particularly an articular region.

[0022] In one embodiment, the mixing device is at least partially disposed within the first container. In other words, at least a part of the mixing device, particularly the mixing element, is disposed within the first container. This enables, in particular, space-saving packaging and reduces the number of working steps during use. The mixing device can be pushed as far as possible into the first container. Typically, the handle of the mixing device is disposed outside the first container. The handle can limit the insertion.

[0023] The mixing device can be delivered in a fully assembled state, i.e., ready for use. Alternatively, only a part of the mixing device, particularly the adapter unit, is connected to the first container, while a further part of the mixing device, particularly the threaded rod with a handle, is disposed separately. In this case, the threaded rod must be connected to the adapter unit before mixing.

[0024] The axial direction, in the context of the present invention, refers to the corresponding longitudinal axis. The axial extension range is the length between the two end portions of a given component. Thus, the axial extension range of the extrusion device refers to the length of the extrusion device along its longitudinal axis. Typically, the extrusion device is configured to move along the longitudinal axis and / or to move the bone cement along the longitudinal axis. The axial extension range of the first container having the mixing device refers to the length of this group of two components in the described state where the mixing device is at least partially disposed within the first container.

[0025] In one embodiment, the extrusion device has an axial extension range A, and the first container having the mixing device has an axial extension range B. The following may be applicable to the ratio A / B, namely, A / B ≧ 0.9, particularly ≧ 1.0 or ≧ 1.1 and / or A / B ≦ 1.5, particularly ≦ 1.4 or ≦ 1.3.

[0026] In other words, the extrusion device is at most 1.5 times larger than the first container having the mixing device. Thus, a compact kit with small packaging dimensions is made possible by a small extrusion device. For example, the extrusion device is at most slightly smaller than the first container having the mixing device, but typically is at least just as large as the first container having the mixing device. This enables the bone cement to be extruded at least almost completely, and in particular completely, from the first container, and moreover it is ensured that neither component is unduly long compared to the other component. However, in particular, the extrusion device is not longer than 1.4 times the first container. This makes it possible in particular to achieve a space-saving packaging size. In addition, a particularly compact shape can be achieved in which the length and width of the kit are within a similar range. For example, the length is at most 50%, preferably at most 35%, particularly at most 20% larger than the width. Such dimensions have been shown to be advantageous with respect to transport and installation during use. In addition, the stability is increased.

[0027] After the bone cement has been completely extruded, the extrusion device is typically partially located within the first container. The axial extension range of the first container having the extrusion device is C. In one embodiment, the ratio is C / A ≦ 1.4.

[0028] In one embodiment, the maximum height of the kit, in particular the packaging means of the kit, is smaller than the length and / or width. In particular, the height is at most 70% of the length and / or width, preferably at most 55% of the length and / or width. In this way, high stability of the kit is ensured.

[0029] In one embodiment, after the bone cement has been completely extruded, the axial extension range of the first container in which the extrusion device is disposed, in particular the axial extension range from the outermost point of the first container to the end of the handle of the extrusion device on the opposite side, is at most 1.2 times the axial extension range of the extrusion device.

[0030] The extrusion device can have a lever system and / or can be designed as a cartridge press. The extrusion device can be driven by a gas cartridge as described, for example, in European Patent No. 2711091 (B1) and / or European Patent No. 2710972 (B1). Each of these documents is incorporated herein by reference.

[0031] In one embodiment, the extrusion device comprises a threaded rod having a male thread, a handle for rotating the threaded rod, and an adapter unit for mechanically connecting to the first container. In particular, the adapter unit comprises a passage opening having a female thread for the threaded rod. Accordingly, the first container is correspondingly designed to be mechanically connected to the adapter unit.

[0032] In particular, connection means for the extrusion device are provided on the adapter unit for connection to the first container. In particular, a connection part is provided for the coupling rotation of the threaded rod at least in the rotational direction so that the attachment of the adapter unit to the first container is not impaired or loosened even when the threaded rod is rotated. When the adapter unit is attached to the first container, the threaded rod moves axially relative to the adapter unit and thus relative to the first container, so that the end of the threaded rod on the side opposite the handle penetrates the first container, and thus bone cement is extruded from the first container. In this way, bone cement can be extruded from the end of the first container on the side opposite the adapter unit.

[0033] In one embodiment, the pitch of the male thread is at least 1 mm, preferably at least 3 mm and / or at most 7 mm, preferably at most 5 mm. This has been proven to be particularly effective in tests. In one embodiment, the outer diameter of the male thread of the threaded rod is at least 12 mm and / or at most 17 mm. The outer diameter means the maximum diameter measured between two maximum peaks of the thread turn, i.e., the diameter of the virtual cylinder surrounding the male thread. In particular, the outer diameter is at least 13.5 mm and / or at most 15 mm. In one embodiment, the outer diameter is approximately or exactly 14 mm. An outer diameter of less than 12 mm is not suitable for withstanding the forces or moments generated. If the outer diameter is too large, the friction increases, and thus the force required for extrusion increases. In one embodiment, the female thread of the adapter unit includes at least two threads, preferably at least or exactly four threads, and / or at most six threads, preferably at most five threads. In one embodiment, the thread of the threaded rod is a trapezoidal thread. This has been proven to be particularly suitable. In one embodiment, the male thread of the threaded rod has a thread depth of at least 1 mm and / or at most 3 mm or 4 mm.

[0034] In one embodiment, to apply pressure to the bone cement within the first container, the extrusion device comprises a pressure element at the end of the threaded rod on the side opposite the handle. In particular, the pressure element has a flat surface. The pressure element can be designed to apply pressure directly or indirectly. In one embodiment, the pressure element is connected to the threaded rod for coupled rotation. For example, the pressure element can be screwed onto the threaded rod, welded to it, or connected to the threaded rod by a bayonet connection. The pressure element can be made entirely or partially of a metal or plastic material, such as a glass fiber reinforced plastic material and / or polyamide. In one embodiment, the pressure element is composed of two parts. The first part of the pressure element is connected to the threaded rod for coupled rotation. The second part of the pressure element is connected to the first part so as to rotate about the longitudinal axis of the threaded rod. To ensure a particularly smooth relative rotation between the first part and the second part, a lubricant such as silicone may be provided between the first parts of the pressure element. In one embodiment, the second part at least partially or circumferentially surrounds the first part. In other words, the second part forms an undercut behind the first part. This ensures that the first part and the second part do not separate from each other. This prevents the axial movement of the second part away from the first part, thus preventing the loss of the second part. In particular, the surface of the second part facing the first part and / or the surface of the first part facing the second part is flat and / or smooth. Each of the pressure element and / or the parts can withstand forces due to a pressure of at least 1 kN, preferably 2 kN.

[0035] These features enable a particularly easy manual discharge of a large amount of bone cement as required for the fixation of an intra-articular prosthesis in human bone tissue. The extrusion device can be manufactured completely or partially at low cost by plastic injection molding.

[0036] In one embodiment, the outer surface of the male thread turn is at most 370 mm 2is. In one embodiment, the outer surface of the male thread turn is at least 230 mm 2 is.

[0037] The outer surface strongly affects the frictional loss when the threaded rod rotates within the adapter unit, and thus the force applied to discharge the bone cement. The outer surface is a measure of the surface area of the male thread that contacts the female thread. Thus, the resulting friction is proportional to the outer surface. Tests have shown that it does not matter whether the reduction of the outer surface is achieved by a reduction in thread depth, an increase in flank angle, a reduction in the diameter of the threaded rod, a reduction in pitch, or other measures, or a combination of different measures. Only the absolute value of the outer surface is important.

[0038] Due to the reduction of friction according to the present invention, even a person with weak strength can easily operate the extrusion device. This is particularly important because the bone cement after mixing continues to solidify over time, and thus the force required to extrude it increases with time. Tests have shown that with the above-described maximum outer surface of the male thread turn, any user can easily discharge the bone cement by manually rotating the handle. If the outer surface becomes larger, discharge becomes very difficult due to static friction and sliding friction, and the ease of handling deteriorates. This design typically enables extrusion of 125 g of polymethylmethacrylate bone cement, which is highly viscous, within a few seconds.

[0039] The lower limit of the outer surface ensures that the mechanical stability of the threaded rod is maintained. For example, if the outer surface is too small, the thread depth or the diameter of the threaded rod may be too small, which may cause shear of the male thread and / or torsion or buckling of the threaded rod.

[0040] The pitch of the male screw also affects the force required for ejection. The pitch of the male screw is the distance measured in the axial direction covered in one rotation. Generally, if the pitch is too short, the rotation ratio becomes very high, and thus more rotations have to be made to eject the bone cement, increasing the labor during use. This can result in an undesirable situation where especially during surgery and / or when the bone cement is gradually hardening, too much time is required. Generally, if the pitch is too long, the rotation ratio becomes low, and thus the force required to eject the bone cement becomes very large. Additionally, if the pitch is too steep, the self-locking function may be reduced or eliminated, which in turn makes the operation unnecessarily complex. The specific numerical values of these effects depend on different conditions such as the materials used and the characteristics of each surface.

[0041] The extrusion device can be made of plastic or plastic with metal. A complex mechanism as seen in a cartridge press is not necessary. Levers, bolts, pins, clamps, locking elements, toothed bars and / or gears are not required. The force required to extrude the bone cement is smaller than the force required by conventional extrusion devices.

[0042] The extrusion device according to the present invention is easy to handle because the complex operation of a cartridge press is not required. The ejection is performed simply by rotating the handle.

[0043] The thread turn means the helix of the thread over a distance corresponding to a complete relative rotation of 360°, i.e., one rotation is considered. The outer surface is the area of the male thread that can contact the corresponding female thread. The outer surface of the thread turn, for example, may include the surface of the first (e.g., ascending) thread flank, the surface of the second (e.g., descending) thread flank, a surface in the region of the thread peak that may extend parallel to the longitudinal axis and / or may be disposed between the thread flanks, and a further surface in the region of the thread trough or valley that may be disposed between the two thread flanks. These four surfaces are added over one rotation. In other words, the surface area between two adjacent peaks or valleys of the thread is considered. The rounding or transition between the individual surfaces is also part of the outer surface. Each characteristic value of the male thread of the threaded rod can be correspondingly applied to the female thread of the adapter unit.

[0044] For example, in the case of a trapezoidal thread, the outer surface corresponds to the surfaces of the two thread flanks, the outward-facing surface between them in the region of the thread peak that defines the outer diameter of the male thread, and the outward-facing surface in the region of the thread valley that defines the inner diameter of the male thread.

[0045] In the case of a multi-start thread, the surface areas of all the thread turns are added over one rotation.

[0046] In one embodiment, the extrusion device is designed to extrude bone cement from the first container with an extrusion force of at least 0.8 kN, particularly at least 1.0 kN. The extrusion force is the force acting on the bone cement in the first container. For example, in the case of a metal cartridge press, the extrusion force is 2.5 kN. However, for a small amount of bone cement for spinal applications, a significantly lower force is applied. Preferably, the extrusion device is designed to be able to extrude a cement amount of 50 g to 125 g within one minute.

[0047] In one embodiment, the kit comprises packaging means. The components of the kit are enclosed in the packaging means so as to be particularly airtight and / or sterile. The components are the first container, the second container, the mixing device, the extrusion device, and, where applicable, the other components described. The packaging means is mainly made of plastic. The packaging means can be designed as a blister. The blister includes, for example, a deep-drawing shell that forms the inside for the arrangement of the components, and a cover that is designed especially as a film. Typically, the cover is flat and thus extends in a plane. The shell and / or the cover of the blister may be transparent, but do not necessarily have to be transparent.

[0048] In one embodiment, the first container contains, as a first component, a powder in an amount of at least 40 g, for example PMMA bone cement powder. In one embodiment, the second container contains, as a second component, a liquid in an amount of at least 18 mL, for example a monomer liquid.

[0049] In one embodiment, the first container contains the first component in an amount of at least 20 g, preferably at least 30 g and / or at most 200 g, preferably at most 120 g, particularly at most 86 g. In one embodiment, the second container contains the second component in an amount of at least 10 mL, preferably at least 15 mL and / or at most 100 mL, preferably at most 75 mL, particularly at most 50 mL or at most 42 mL. These amounts have proven to be optimal for fixing an intra-articular prosthesis to bone.

[0050] In one embodiment, the second container is arranged within a device for housing and opening the second container. The device for housing and opening the second container is fluidly connected or connectable to the first container for transferring the second component to the first container.

[0051] The device for storing and opening, on the one hand, is designed to store at least one second container. In particular, the device completely encloses at least one second container and thus provides mechanical protection. In addition, the device comprises means for opening the container. In the case of a pouch, this can be, for example, a needle or a cone. In the case of an ampoule, this can be a breaking mechanism that separates a part of the ampoule, for example the head of the ampoule, from another part of the ampoule and / or breaks and opens the ampoule, for example by buckling or shearing. For example, there may be two pouches on both sides of the first container, and optionally two needles. Typically, there is a seal around the needle and it is positioned against the wall of the pouch.

[0052] The device for storing and opening the second container can, in particular, comprise a manually operable pump for pumping the liquid into the first container. For example, the device is designed according to European Patent No. 3093067 (B1). This document is incorporated herein by reference. Alternatively or additionally, the device for storing and opening the second container can be designed to carry the liquid into the first container by gravity. In this way, the use of a kit independent of an external vacuum source is possible. Or the device can be designed to carry the liquid into the first container by vacuum. For example, this device is designed according to European Patent No. 2404864 (B1) or European Patent No. 4282518 (A1). These documents are incorporated herein by reference.

[0053] This embodiment enables opening the second container and transferring the second component to the first container. The connection between the device and the first container is preferably reversible, i.e., manually removable. Thus, the device for storage and opening can be removed from the first container after the second component has been transferred to enable or simplify the discharge of the bone cement. Preferably, the device for storage and opening comprises a connection area, the first container comprises a connection area, and the two connection areas can be manually, particularly reversibly, connected to each other. In the connected state, the second component can be transferred from the second container to the first container. The connection area of the first container for connecting the device for storage and opening can be the connection area of the first container to which the mixing device can also be connected or another connection area. In the second case, the two connection areas of the first container can be arranged on the same side or on opposite sides.

[0054] In one embodiment, the first container is arranged separately from the extrusion device. In one embodiment, the second container is arranged separately from the extrusion device. In particular, the device for storing and opening the second container is arranged together with the second container separately from the extrusion device.

[0055] In other words, a given container is arranged spatially separated from the extrusion device. A given component can be arranged within the same space of the packaging means but is not directly mechanically connected to each other. This enables a particularly small packaging size of the components and thus small dimensions of the kit. Since the absolute length of the kit is limited, space can be saved. The long components of the kit can be arranged in parallel. In particular, a compact shape is achieved in which the length and width of the kit are within a similar range. For example, as described above, the length is only marginally larger than the width, resulting in the above advantages. However, when the extrusion device is mechanically connected to the first container, these advantages are not achieved as the length increases and the width decreases.

[0056] In one embodiment, the mixing device is at least partially disposed within the first container. The first container having the mixing device and the extrusion device are arranged in parallel, preferably one above the other. Typically, the extrusion device is disposed at the bottom. In this way, a particularly space-saving arrangement can be achieved. At the same time, the order of use of the components during the use of the kit is taken into account. This is because the first container having the mixing device and the extrusion device are always required sequentially. After the bone cement is prepared, the user can remove the extrusion device, connect it to the first container, and extrude the bone cement. This prevents incorrect operation, eliminates the need for extra space for temporary storage of the components, and avoids dropping of the components. The described arrangement is particularly disposed within the packaging means.

[0057] In one embodiment, the first container, the second container, the mixing device, and the extrusion device are composed of a total of at most 20% steel or at most 20% metal. This reduces the cost, manufacturing effort, and weight of the kit. In one embodiment, the above components are made of at most 20% steel or metal, or do not contain steel and / or metal. In one embodiment, the extrusion device is composed of at most 50%, preferably 30% metal. When no metal or only a small amount of metal is contained, the kit or a given component thereof can be easily recycled or thermally recycled.

[0058] In one embodiment, the adapter unit can be or can be mechanically connected to the first container. In one embodiment, the adapter unit has a support surface for standing the adapter unit together with the first container on a smooth surface and / or on a holder of the packaging means. Thus, the adapter unit can serve as a support for the first container. The support surface of the adapter unit can stand on a surface or a holder. The adapter unit has a connection region for connecting to the first container, particularly on the side opposite the support surface when viewed in the axial direction. Thus, the adapter unit can stand on its support surface and at the same time hold the first container. In particular, the packaging means comprises a holder on which the support surface can be placed. In particular, the contour of the holder and the contour of the support surface preferably correspond three-dimensionally so as to achieve a particularly firm hold.

[0059] In one embodiment, the device for accommodating and opening the second container comprises a buckling region that can move, particularly rotate, the regions of the device relative to each other. The buckling region is designed such that buckling occurs due to relative movement, particularly such that the second container designed as an ampoule is destroyed. In particular, the device is designed to be flexible at least in the buckling region.

[0060] In one embodiment, the device for housing and opening the second container comprises an outer shell, an inner shell, and a break-open element. Generally, the break-open element is used to break-open the ampoule. In particular, each of the two shells surrounds a part of the second container designed as an ampoule. The outer shell and the inner shell are movable relative to each other, in particular displaceable. When relative movement between the outer shell and the inner shell takes place, the ampoule moves relative to the break-open element. The break-open element can be designed, for example, as described in European Patent Application Publication No. 23177510.7, which is incorporated herein by reference. The break-open element can be a shearing element. The shearing element is arranged such that when the outer shell and the inner shell are relatively displaced, it contacts the ampoule, in particular the head of the ampoule, and the ampoule is opened. The shearing element can typically apply a shearing force to the head of the ampoule and break the ampoule at a desired breaking point. These embodiments enable the production of bone cement in a closed system that excludes any contact between the user and the components.

[0061] In one embodiment, the kit comprises two first containers each containing a first component for producing bone cement, two second containers each containing a second component for producing bone cement, and only one extrusion device. The extrusion device can optionally be mechanically connected to each of the first two containers, and using the extrusion device, the prepared bone cement can be sequentially extruded from each of the first two containers. The kit may optionally comprise a mixing device that can be mechanically connected to each of the first two containers to mix the two components. Alternatively, the kit may have two mixing devices to enable mixing in each of the two first containers using separate mixing devices.

[0062] In one embodiment, the first container, the second container, the mixing device, and / or the extrusion device are designed as described in European Patent No. 2281532 (B1), European Patent No. 2269718 (B1), European Patent No. 3093067 (B1), and / or European Patent Application Publication No. 22174728 (A1). Each of these documents is incorporated herein by reference.

[0063] In one embodiment, the first container, the second container, the mixing device, and / or the extrusion device are designed such that after opening the second container, the monomer liquid can be sucked into the powder by an external vacuum, and then the two components can be mixed by a mixing device that can be operated externally. Alternatively or additionally, the transfer of the second component can be carried out in two steps where the liquid can first flow into the collection volume by the effect of gravity and then be pumped from there into the first container, for example, by a manually operated pump plunger.

[0064] A further aspect of the invention is the use of the kit according to the invention for extruding bone cement from the first container. In particular, an amount of bone cement of at least 50 g and / or at most 130 g is extruded. In particular, the extrusion is carried out by an extrusion device. In particular, PMMA bone cement is extruded. In particular, this is carried out for fixing an intra-articular prosthesis to human bone tissue. In particular, the handle of the extrusion device is manually rotated so that the bone cement is extruded from the first container. All features, advantages, and embodiments of the aforementioned kit and its components and characteristics apply equally to the following uses and methods, and vice versa.

[0065] A further aspect of the invention is a method of using the kit according to the invention. This includes - using a mixing device to mix a first component and a second component in the first container to produce bone cement, - removing the extrusion device from the packaging means of the kit, - using the extrusion device to extrude the produced bone cement from the first container. ​

[0066] The method may further include any combination of one or more of the following steps. - Opening the packaging means, - Removing the first container and / or the second container from the packaging means, - Opening the second container and transferring the second component to the first container, - Connecting the mixing device to the first container, - After mixing, removing the mixing device from the first container, - Connecting the extrusion device to the first container, - Connecting a tubular body to the first container for extrusion, particularly on the side of the first container opposite to the extrusion device.

[0067] Exemplary embodiments of the present invention are also described in more detail below with reference to the drawings. The features of the exemplary embodiments can be combined individually or in combination with the plurality of claimed subject matters, unless otherwise specified. The scope of the claimed protection is not limited to the exemplary embodiments.

Brief Description of the Drawings

[0068] In the drawings,

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15A

Figure 15B

Figure 15C

Figure 16

Figure 17A

Figure 17B

Figure 17C

[0069] Figures 1 and 2 show kit 10 according to the invention for manufacturing and extruding bone cement. The kit comprises a first container 12, a second container 70, an extrusion device 10, and a mixing device 74. The mixing device 74 is mechanically connected to the first container 12 such that after transferring the second component from the second container 70 to the first container 12 containing the first component, the two components can be mixed using the mixing device 74 to obtain bone cement. The kit also includes a knee snorkel 54 and a flat snorkel 55, as well as a vacuum hose 50 for connecting the first container 12 to a vacuum source. The second component can advantageously be sucked into the first container 12 by vacuum. However, in the design shown here, operation without using vacuum is also possible. Adjacent to the right of the first container 12, there is arranged a pumping device 11 that can be used to pump liquid into the first container. The pumping device can be designed as described in German Patent Invention No. 102015106899 (B3) which is incorporated herein by reference.

[0070] The kit further comprises packaging means 77 in which the components are specifically packaged. The packaging means 77 comprises in particular a deep-drawn tray 78 having a widened peripheral part and a cover 79 attached to the edge, for example welded or glued. The packaging means 77 has a substantially square basic shape.

[0071] The mixing device 74 is partially arranged within the first container 12. With respect to the axial elongation range A of the extrusion device 10 and the axial elongation range B of the first container 12 having the mixing device 74, A / B is between 1.0 and 1.2. In the case shown here, A / B is approximately 1.1.

[0072] Figures 3 and 4 show another embodiment of the kit 1 in which the packaging means 77 has an elongated basic shape. In the embodiment shown here, the kit 1 includes a device 85 for receiving and opening a second container 70 that houses the second container. The device 85 is mechanically connected to the first container 12, particularly reversibly. This makes it easier to use because there is no need to establish the connection initially. Figure 3 shows a two-part extrusion device 10. The adapter unit 26 of the extrusion device is mechanically connected to one end of the first container 12 on the side opposite the device 85. The handle portion of the extrusion device 10 having the threaded rod 20 and the handle 24 is arranged separately from and / or adjacent to the first container 12. The adapter unit 26 can have a support surface for standing on a smooth surface and / or on a holder of the packaging means on the side opposite the first container 12 with respect to the axial elongation range (see FIGS. 15A - 15C). This makes it easier to stand the first container 12 for mixing and / or after mixing.

[0073] However, in the embodiment shown in FIG. 4, the extrusion device 10 is arranged completely separately from and / or adjacent to the first container 12. The threaded rod 20 is screwed into the adapter unit 26. The kit 1 further includes a vacuum hose 50, a knee pressurizer 52, a waist pressurizer 53, a knee snorkel 54, and a flat snorkel 55.

[0074] FIG. 5 shows an embodiment of an apparatus 85 for receiving and opening a first container 12 and a second container 70, such as that according to FIG. 3 described above, and an extrusion device 10. The apparatus 85 houses a second container 70 designed as an ampoule 83 having a second component 82, namely a monomer liquid. The first component 81 is bone cement powder disposed within the first container. The apparatus 85 includes a buckling region 87 where the apparatus 85 can be buckled to break the head 84 of the ampoule 83. Subsequently, the head 84 and any glass fragments are retained by a sieve, and the liquid can flow into the second container through a collection volume 86, a filter element if applicable, a tube element 57, and a further filter element if applicable. This can be done by gravity and / or vacuum. To apply a vacuum, the first container 12 includes a nozzle (not shown here, see FIG. 15A) leading to a vacuum chamber 58. This is connected internally to the first container 12 by a mesh or sieve. When a vacuum is applied, the liquid is sucked in through the tube element 57.

[0075] In the embodiment shown here, the adapter unit 26 of the extrusion device includes a support surface 60. Thus, the adapter unit can be used to hold the first container 12. For example, the opening of the ampoule 83 and the transfer of the liquid to the first container 12, at least partially by gravity, can be done when the first container 12 is in an upright position by the support surface 60. The adapter unit 26 includes an internal thread 28 for screwing onto the threaded rod 20 of the extrusion device 10 shown in FIG. 6.

[0076] On the opposite side of the first container 12, an adapter unit 25 of a mixing device 74 is arranged. The mixing device 74 further includes a rod 76 that passes through the adapter unit 25 and connects a mixing element 75 to a handle 24.

[0077] FIG. 5 shows the release mechanism of the mixing device 74. When the operating element on the handle 24 is actuated in a suitable manner, in particular when fully withdrawn, the handle 24 can be released from the rod 76. The rod 76 is designed as a hollow rod in this case. After the handle is released, the rod 76 can be used as a discharge pipe for discharging the bone cement. The mixing element 75 remains particularly fixed within the first container 12, for example within the region of the end face shown on the left side. This state is also shown in FIG. 12.

[0078] An alternative embodiment of the device 85 for receiving and opening the second container 70 is shown in FIGS. 7 and 8. The device 85 comprises an inner shell 90 in which the ampoule 83 is arranged and an outer shell 89 which at least partially surrounds the inner shell 90. The inner shell 90 is axially displaceable relative to the outer shell 89, at least in the direction of the first container, for example in a telescopic manner, but can be held by a fixing device 91 in the form of a removable fixing clip, for example. When the fixing device 91 is inserted, the movement of the inner shell 90 is blocked. When the fixing device is removed, the inner shell 90 can move towards the first container. The device 85 further comprises a shearing element 88 for shearing the head 84 of the ampoule 73. The shearing element typically includes a surface which is oriented obliquely with respect to the longitudinal extension of the ampoule 83. When the inner shell 90 is pushed towards the first container 12 together with the ampoule 83, the head 84 contacts the shearing element 88 and is thereby sheared.

[0079] Figure 8 shows how, in the above-described or similar embodiments, the device 85 can be used to pump liquid into the first container 12, comprising an outer shell 89 and an inner shell 90 movable relative to the outer shell 89. As shown in Figure 8, by pulling out the inner shell 90, the volume within the device 85 increases and air flows into the device 85, for example through a suitable valve within the cover of the device 85. When then pushed in, the air displaces the liquid within the device 85, for example within the collection volume 86, which had previously flowed out of the ampoule 83, and pushes this liquid into the first container. In this way, a vacuum source can be dispensed with and the kit can be used for cementing without any additional devices.

[0080] Figure 9 shows the separation of the device 85 from the first container 12. At least one retaining part 92, which had previously established the connection, can be removed. Subsequently, it is possible to more easily mix and / or extrude the bone cement. The separation can be irreversible. A closure element, for example a gate valve, can close the opening of the first container 12 through which the tube element 57 had previously protruded.

[0081] Figure 10 shows an embodiment in which the mixing device 74 is connected to the first container and the extrusion device 10, in particular the discharge tube 51, is provided separately therefrom. The mixing device 74 comprises an adapter unit 25 and the extrusion device 10 comprises an adapter unit 26. Both adapter units can be attached to the same side of the first container 12. The discharge tube 51 can be attached to the other side of the first container 12.

[0082] Figure 11 shows another embodiment in which the adapter unit 25 of the mixing device 74 and the adapter unit 26 of the discharge device are arranged on opposite sides of the device. Figure 12 shows the extrusion of the bone cement 15 through the discharge tube 51 by the extrusion device 10.

[0083] Figures 13 and 14 show cross-sectional views of the extrusion device 10 along the central longitudinal axis. The extrusion device 10 comprises an adapter unit 26 having a connection region 37 for mechanical connection to the first container. In the embodiment shown here, the connection region 37 can be inserted and / or screwed into the corresponding region of the first container. In the embodiment shown here, the adapter unit 26 has a connection element 29 for generating a bayonet connection. The direction of rotation for tightening the bayonet connection corresponds to the direction of rotation for screwing into the threaded rod 20.

[0084] The extrusion device 10 further comprises a threaded rod 20 having an external thread 22. The threaded rod 20 is passed through the passage opening 27 such that the external thread 22 engages with an internal thread 28 disposed in the passage opening 27. A manual operation handle 24 for rotation is disposed at the end of the threaded rod 20 shown on the right side. When the threaded rod 20 is rotated, the threaded rod moves axially through the adapter unit 26 so as to be able to extrude bone cement.

[0085] At the end of the threaded rod 20 remote from the handle 24, the threaded rod 20 is designed to apply pressure or force to the bone cement. For this purpose, a pressure element 30 may be present. The pressure element 30 serves to apply pressure directly or indirectly thereto in order to extrude the bone cement from the first container. For example, the pressure element 30 can move the plunger of the first container, and the plunger then extrudes the bone cement from the first container. The pressure element 30 will be described in detail below.

[0086] The threaded rod 20 can have an inner core that is a metal rod 40 in the example shown here, and / or a casing that is a plastic casing 41 in the example shown here. The metal rod 40 extends centrally inside the threaded rod 20 and significantly contributes to the mechanical stability of the threaded rod 20. The plastic casing 41 forms the male thread 22 and protects the metal rod 40 from external influences. The metal rod 40 is preferably not rotationally symmetric for the handle 24 for coupled rotation and / or to ensure connection to the casing.

[0087] For example, the metal rod 40 can be hexagonal or square. In particular, a metal rod 40 containing or made from stainless steel such as 316L is used. In particular, the metal rod 40 is completely encapsulated by a plastic material. In particular, the thread is made of plastic. Thereby, a particularly smooth thread is provided. The metal rod 40 is protected from external influences. In one embodiment, the metal rod 40 has a diameter of at least 7 mm and / or at most 10 mm, preferably about 8 mm or exactly 8 mm.

[0088] In one embodiment, the threaded rod 20 has a length L of at least 15 cm and / or at most 23 cm. The length of the threaded rod 20 is in particular at least 17 cm, preferably at least 19 cm and / or at most 23 cm, preferably at most 21 cm. The length L is measured between the outermost regions where the male thread 22 is present. Further, the outer diameter D of the threaded rod 20, measured radially between the peaks of the male thread 22 A is shown. The outer diameter D in the example shown here A is between 13.5 mm and 15 mm.

[0089] In one embodiment, the adapter unit comprises a connection region for insertion into the first container. In one embodiment, the connection region has an inner diameter of at least 3.3 cm and / or at most 4.0 cm. In one embodiment, the threaded rod does not include a metal part other than the metal rod.

[0090] In FIG. 13, the position where the threaded rod 20 is fully screwed back from the adapter unit 26 is shown. In contrast, FIG. 14 shows the position where the threaded rod 20 has already been partially rotated through the adapter unit 26, as seen when extruding the bone cement.

[0091] In one embodiment, the adapter unit 26 comprises a recess 35 that can fully receive the pressure element 30. In this way, the connection region 37 of the adapter unit 26 shown on the left remains free from the pressure element 30. Thus, the connection region 37 can be slid onto, inserted into, or screwed onto the corresponding end of the first container without interfering with the pressure element 30.

[0092] As shown in FIGS. 13 and 14, the pressure element 30 can be composed of two parts. The first part 31 can be firmly connected to the threaded rod 20 in this case, so that when the threaded rod 20 rotates, it rotates with it. The second part 32 can be rotatably connected to the first part 31 so that the second part 32 does not rotate when the threaded rod 20 is rotated. In this way, no rotational movement is applied to the bone cement 15 and / or the plunger, and only axial pressure is applied. The contact surface between the first part 31 and the second part 32 is preferably flat and smooth to allow smooth rotation.

[0093] In the example shown here, the second part 32 of the pressure element 30 surrounds the first part 31 of the pressure element 30 and / or forms an undercut 34 together with the first part 31. On the right side, the circumferential outer rim of the second part 32, in particular, extends inward and engages behind the radially outer edge of the first part 31. The first part 31 and / or the second part 32 can be designed in the form of a plate. The second part 32 may have a diameter of at least 20 mm and / or at most 30 mm, for example, approximately or exactly 25 mm.

[0094] Different embodiments of the pressure element 30 are shown in FIGS. 15A - 15C. In principle, the pressure element 30 presses and extrudes the bone cement. In particular, this is done indirectly by the pressure element 30 pressing the plunger 13, which then contacts the bone cement. In FIG. 15A, the pressure element 30 comprises only a first part 31 fixedly or rotatably connected to the threaded rod 20. This structure is particularly simple. However, the plunger 13 may also rotate, which increases friction and thus the force required for extrusion. FIG. 15B shows a two - part configuration of the pressure element 30. Between the first part 31 and the plunger 13, there is a second part 32 of the pressure element 32 arranged rotatably with respect to the first part 31. The second part 32 extends over substantially the entire inner diameter of the corresponding region of the plunger, and advantageously, there should remain at least a small distance between the inner circumferential surface of the plunger 13 and the second part 32 so that no friction occurs here. The second part 32 may be a flat disk. In particular, there is a lubricant such as silicone between the two parts 31, 32 to allow smooth rotation. The first part 31 can be connected to the threaded rod 20 in a fixed manner so as not to rotate. There is rotation between the first part 31 and the second part 32, but no rotation between the second part 32 and the plunger 13. This reduces friction and thus the required force. FIG. 15C shows a further embodiment where the first part 31 is designed as a flat disk arranged within the recess of the second part 32. The threaded rod rotates only the flat first part 31, and the second part 32 does not rotate with the plunger 13. The parts 31, 32 evenly transmit the force of the extruding device and prevent the plunger 13 from tilting.

[0095] FIG. 16 is an enlarged cross - sectional view of the threaded rod 20. It comprises an inner metal rod 40 and a plastic casing 41 that completely encloses the metal rod 40. The outer diameter D of the threaded rod 20 corresponding to the maximum diameter between the peaks on both sides of the male thread 22 Ais shown. In addition, the inner diameter D of the threaded rod 20 corresponding to the minimum diameter between the recesses or valleys on both sides of the male thread 22 I is shown. The thread has a thread depth between 1 mm and 2 mm. Therefore, the inner diameter D I and the outer diameter D A The difference between them is between 2 mm and 4 mm.

[0096] The thread turn 66 is delimited by a dashed line as an example. The thread turn corresponds to a complete one revolution of the male thread 22 with respect to the corresponding female thread. The threaded rod 20 can be designed such that the outer surface of the thread turn 66 of the male thread is at most 370 mm 2 In the example of the trapezoidal thread shown here, the outer surface of the thread is determined as the sum of the upper surface 61 corresponding to the surface of the peak region of the thread, the lower surface 62 corresponding to the surface of the recess region of the thread, the first (rising) flank surface 63, and the second (falling) flank surface 64.

[0097] In one embodiment, the outer surface of the thread turn of the male thread is at most 450 mm 2 , at most 430 mm 2 , at most 400 mm 2 , at most 370 mm 2 , at most 350 mm 2 , at most 330 mm 2 , or at most 300 mm 2 is. In one embodiment, the outer surface of the thread turn of the male thread is at least 100 mm 2 , at least 130 mm 2 , at least 160 mm 2 , at least 180 mm 2 , at least 200 mm 2 , at least 215 mm 2 , at least 250 mm 2 , at least 280 mm 2 , at least 320 mm 2 , or at least 350 mm 2 is. These values may be particularly appropriate depending on the design and materials.

[0098] In one example, the threaded rod has an outer diameter DA of 14 mm, a thread depth (tooth height) of 1.5 mm, and a pitch of 4.5 mm. These values represent a good compromise between the amount of advancement per revolution and the force required for rotation. Additionally, since the threaded rod 20 has a suitable self-locking mechanism, it has no tendency to reverse during extrusion.

[0099] Figures 17A - 17B show the use of the holder 80 within the packaging means 77. The adapter unit 26, particularly the extrusion device 10, is connected to the first container 12 on the side facing away from the device 85. The adapter unit 26 comprises a support surface 60. The support surface 60 corresponds to a holder 80 that is arranged or formed inside the packaging means 77, for example, by deep drawing. Both the support surface 60 and the holder 80 are designed as three-dimensional structures that ensure good connection and thus stable retention. However, in contrast, when the adapter unit 26 is designed as a hollow cylinder, it can be stood on a flat surface.

[0100] Figure 17A shows the state immediately before standing the first container 12 on the support surface 80. Figure 17B shows the standing state. The device for storing and opening the second container is connected to the second container 70, and the mixing device is connected to the first container. In Figure 17C, the mentioned devices are removed. Mixing can now be started. This can be done particularly easily and safely because the first container 12 stands firmly and securely.

Explanation of Reference Numerals

[0101] 1 Kit 10 Extrusion device 11 Pressing device 12 First container 13 Plunger 15 Bone cement 20 Threaded rod 22 Male thread 24 Handle 25 Adapter unit 26 Adapter unit 27 Passage opening 28 Female thread 29 Connecting element 30 Pressure element 31 First part 32 Second part 34 Undercut 35 Recess 37 Connection area 40 Metal rod 41 Plastic casing 50 Vacuum hose 51 Discharge pipe 52 Knee press 53 Lumbar press 54 Knee snorkel 55 Flat snorkel 57 Pipe element 58 Vacuum chamber 59 Nozzle 60 Support surface 61 Upper surface 62 Lower surface 63 First flange surface 64 Second flange surface 66 Thread turn 70 Second container 74 Mixing device 75 Mixing element 76 Rod 77 Packaging means 78 Shell 79 Cover 80 Holder 81 First component 82 Second component 83 Ampoule 84 Head 85 Device 86 Collection volume 87 Buckling region 88 Shearing element 89 Outer shell 90 Inner shell 91 Fixing device 92 Holding part D Inner diameter D I Inner diameter DA Outer diameter L length A axial direction elongation range B1 axial direction elongation range

Claims

1. A kit (1) for producing and extruding a bone cement (15), comprising: a first container (12) containing a first component (81) for producing a bone cement (15), a second container (70) containing a second component (82) for producing the bone cement (15); a mixing device (74) for manually mixing said first component (81) and said second component (82) in said first container (12) to produce a bone cement (15); - an extrusion device (10) for manually extruding the prepared bone cement (15) from the first container (12); A kit (1).

2. The mixing device (74) is at least partially disposed within the first vessel (12), the extrusion device (10) has an axial extension range A, the first vessel (12) containing the mixing device (74) has an axial extension range B, and for a ratio A / B, the following is satisfied: A / B≧0.9 and / or A / B≦1.5 2. The kit (1) according to claim 1, characterized in that:

3. 2. The kit (1) according to claim 1, characterized in that the extrusion device (10) comprises a threaded rod (20) having an external thread (22), a handle (24) for rotating the threaded rod (20) and an adapter unit (26) for mechanically connecting to the first container (12), the adapter unit (26) comprising a passage opening (27) having an internal thread (28) for the threaded rod (20).

4. The outer surface of the thread turn (66) of the male thread (22) is at most 370 mm ２ and / or at least 230 mm ２ The kit (1) according to claim 3, characterized in that

5. 2. The kit (1) according to claim 1, characterized in that the extrusion device (10) is designed to extrude the bone cement (15) from the first container (12) with an extrusion force of at least 0.7 kN, in particular at least 1.0 kN.

6. The kit (1) according to claim 1, characterized in that the kit (1) comprises a packaging means (77) and the components of the kit (1) are enclosed in the packaging means (77) in a particularly airtight and / or sterile manner.

7. 2. The kit (1) according to claim 1, characterized in that the first container (12) contains, as the first component (81), a quantity of PMMA bone cement powder of at least 40 g and / or the second container (70) contains, as the second component (82), a quantity of monomer liquid of at least 18 ml.

8. 2. The kit (1) of claim 1, characterized in that the second container (70) is disposed in a device (85) for storing and opening the second container (70), and the device (85) for storing and opening the second container (70) is fluidly connected or can be connected to the first container (12) for transferring the second component (82) to the first container (12).

9. 2. The kit (1) according to claim 1, characterized in that the first container (12) and / or the second container (70) are arranged separately from the extrusion device (10).

10. 2. The kit (1) according to claim 1, characterized in that the mixing device (74) is at least partially arranged within the first container (12), and the first container (12) having the mixing device (74) and the extrusion device (10) are arranged in parallel, preferably one above the other.

11. 2. The kit (1) according to claim 1, characterized in that the first container (12), the second container (70), the mixing device (74) and the extrusion device (10) are made up of a maximum of 20% metal in total.

12. said adapter unit (26) being mechanically connected or connectable to said first container (12), said adapter unit (26) comprising a support surface (60) for standing said adapter unit (26) together with said first container (12) on a smooth surface and / or on a holder (80) of said packaging means (77); In particular, said packaging means (77) comprises a corresponding holder (80) A kit (1) according to claim 3, characterized in that

13. The device (85) for receiving and opening the second container (70) comprises: - comprising a buckling area (87) for buckling said device (85) so that said second container (70) can be opened by buckling, or - comprising an outer shell (89), an inner shell (90) and a shearing element (88), said outer shell (89) and said inner shell (90) being displaceable relative to one another, said second container (70) being moved by relative displacement with respect to said shearing element (88) in order to open said second container (70) by shearing a portion of said second container (70); A kit (1) according to claim 8, characterized in that

14. Use of the kit (1) according to claim 1 for extruding an amount of bone cement (15) between 50g and 130g from said first container (12).

15. - mixing said first component (81) and said second component (82) in said first container (12) using said mixing device (74) to produce a bone cement (15); - removing said extrusion device (10) from the packaging means (77) of said kit (1); - extruding the prepared bone cement (15) from the first container (12) using the extrusion device (10); A method of using the kit (1) according to claim 1, comprising:

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