Apparatus for providing a liquid component of a cement bolus, system for providing a cement bolus and method

Abstract

The present invention provides an apparatus for providing a liquid component as a first starting component of a bone cement clump from two starting components. The apparatus includes: a receiving container in which a reservoir containing the liquid component is stored; an opening device for opening the reservoir; a reservoir fluidly connected to the receiving container for receiving the liquid component from the reservoir; at least one port for fluidly connecting the apparatus to a syringe in which a powder component is stored as a second starting component of the bone cement clump; and at least one connecting device for fluidly connecting the reservoir and the at least one port to each other.

Description

[0001] The present invention relates to an apparatus for providing a liquid component as a first starting component of a bone cement block from two starting components, the apparatus comprising: a receiving container, wherein a storage tank for storing the liquid component is disposed of in the receiving container;

[0002] An opening device for opening the storage tank;

[0003] A storage container, fluidly connected to the receiving container, for receiving the liquid component from the storage tank;

[0004] At least one port for fluidly connecting the device to a syringe in which a powder component can be stored as a second starting component of the bone cement clump; and at least one connecting device for fluidly connecting the reservoir and the at least one port to each other.

[0005] The present invention also relates to a system for providing bone cement lumps from two starting components, the system comprising: such a device; a tank containing a liquid component as the first starting component; and a plurality of syringes, each containing a powder component as the second starting component, and the present invention also relates to a method for providing bone cement lumps from two starting components by means of such a system. Background Technology

[0006] The common procedure for treating vertebral fractures is vertebroplasty. In this procedure, the fractured vertebral body is stabilized with bone cement (e.g., polymethyl methacrylate bone cement or inorganic bone cement). For this purpose, the bone cement is introduced into the vertebral body as a mass in a liquid to viscous state and then solidifies therein to form bone cement.

[0007] Bone cement boluses are typically provided by mixing two starting components (i.e., a liquid component and a powder component), with the hardening of the bolus beginning with the mixing of the starting components. Within minutes, for example, 10 minutes, the provided bone cement bolus is fully hardened to form bone cement. For vertebroplasty, surgeons have only a limited time window after the bone cement bolus has been provided and before it has exceeded its processing time and may no longer be needed.

[0008] Small syringes (e.g., syringes with a capacity of up to 10 ml) are used in vertebroplasty for surgical technique-related reasons, and particularly due to improved procedures. Since a larger mass of bone cement than the capacity of one of these small syringes is typically required, multiple syringes must be provided to accommodate the bone cement mass for the surgery.

[0009] Bone cement typically purchased on the retail market comes in packages large enough to fill multiple syringes used in vertebroplasty. For commercial reasons, it would be unwise to mix bone cement clumps for only one syringe in each case and discard the remainder. Therefore, large quantities of bone cement clumps have thus been supplied by means of individual packages (e.g., in the form of a reservoir for the liquid component and a single bag for the powder component), which are then dispensed into multiple syringes.

[0010] For example, US Patent Specification 8,348,494B2 is mentioned here, in which previously provided bone cement clumps are dispensed into multiple syringes for application into a patient's body.

[0011] This is disadvantageous because the treatment time for the bone cement bolus begins simultaneously for all syringes; that is, the treatment time starts from the initial mixing of the entire volume of bone cement bolus. This places considerable time pressure on the surgeon, as all syringes must be used within the treatment time. Furthermore, this situation results in the use of only boluses with relatively long treatment times if multiple syringes filled with bone cement boluses are used, for example, to stabilize multiple vertebral bodies. This limits the surgeon's choice of available bone cement boluses. Simultaneously, the rheological properties of the initially mixed bone cement boluses dispensed into the syringes differ. While the first bolus used during surgery may still have a relatively low viscosity, the bolus in the last syringe used may have a significantly higher viscosity. This makes performing the surgery more difficult. If the application of the bone cement bolus takes a long time, particularly exceeding the treatment time of the initially provided bolus, one or more of the previously filled syringes may no longer be used. This necessitates the use of additional packaging (e.g., additional tanks containing the liquid components that form the starting material for the bone cement clumps) to supply additional bone cement clumps, which is also commercially disadvantageous.

[0012] Purpose of the invention

[0013] The object of this invention is to overcome, at least in part, one or more of the disadvantages caused by the prior art.

[0014] Specifically, the objective of this invention is to provide a device that enables the supply of multiple syringes filled with bone cement clumps available from two starting components, wherein the bone cement clumps are designed to be supplied to all syringes from a single package comprising a container for the powder component and a reservoir for the liquid component, without requiring the user of the device to use all syringes within a time period corresponding to the processing time of the bone cement clumps. The device should also allow for the use of rapidly hardening bone cement clumps. The device should allow for the direct mixing of the bone cement clumps within the syringes, eliminating the need for the surgeon to transfer the bone cement clumps into the syringes.

[0015] Another object of the present invention is to provide a system for providing bone cement lumps from two starting components, the system including such a device, by means of which at least some of the described objectives are achieved at least in part.

[0016] Another object of the present invention is to provide a method by means of providing bone cement lumps from two starting components, by means of which at least some of the described objectives are achieved at least partially.

[0017] Preferred embodiments of the present invention

[0018] The features of the independent claim contribute to at least partially satisfying at least one of the foregoing objectives. The dependent claims provide preferred embodiments that contribute to at least partially satisfying at least one of these objectives.

[0019] A first embodiment of the present invention is an apparatus for providing a liquid component as a first starting component of bone cement lumps from two starting components, the apparatus comprising:

[0020] A receiving container, which may store a tank containing the liquid component;

[0021] An opening device for opening the storage tank;

[0022] A storage container, fluidly connected to the receiving container, for receiving the liquid component from the storage tank;

[0023] At least one port for fluidly connecting the device to a syringe, the syringe being capable of storing powder components as a second starting component of the bone cement clump; and

[0024] At least one conducting device that fluidly connects the reservoir and the at least one port to each other.

[0025] In one embodiment, the device includes: a plurality of ports, particularly two, three, four, or five ports, for fluidly connecting the device to a syringe in which a powder component can be stored as the second starting component of the bone cement clump; and a plurality of connecting devices, particularly two, three, four, or five connecting devices, wherein one of the connecting devices fluidly connects the reservoir and one of the ports to each other in each case. This embodiment is a second embodiment of the invention, which preferably depends on a first embodiment of the invention.

[0026] In one embodiment of the device, the reservoir is divided into multiple compartments, particularly two, three, four, or five compartments, wherein in each case, one of the compartments is fluidly connected to one of the ports via one of the multiple connecting devices. This embodiment is a third embodiment of the invention, which preferably depends on a second embodiment of the invention.

[0027] In one embodiment of the device, the compartments each have substantially equal volumes. This embodiment is a fourth embodiment of the invention, which preferably depends on a third embodiment of the invention.

[0028] In one embodiment of the device, the reservoir is divided into compartments by means of at least one partition wall. This embodiment is a fifth embodiment of the invention, which preferably depends on a third or fourth embodiment of the invention.

[0029] In one embodiment of the device, the compartment is fluidly open on the upper compartment side facing the containment in each case, such that the compartments are fluidly connected to each other via the upper compartment side. This embodiment is a sixth embodiment of the invention, which preferably depends on a fifth embodiment of the invention.

[0030] In one embodiment of the device, the at least one conducting device is a tube. This embodiment is a seventh embodiment of the invention, which preferably depends on one of the foregoing embodiments of the invention.

[0031] In one embodiment of the device, the tube has an inner diameter ranging from 0.5 mm to 3 mm. This embodiment is an eighth embodiment of the invention, which preferably depends on a seventh embodiment of the invention.

[0032] A ninth embodiment of the present invention is a system for providing bone cement lumps from two starting components. The system includes an apparatus according to an embodiment of the foregoing embodiments of the present invention, wherein a tank containing a liquid component as the first starting component is stored in the receiving container, and the system includes a plurality of syringes, particularly two, three, four or five syringes, each syringe containing a powder component as the second starting component.

[0033] In one embodiment of the system, the device includes multiple ports, particularly two, three, four, or five ports, wherein the number of ports corresponds to the number of syringes. This embodiment is a tenth embodiment of the invention, which preferably depends on a ninth embodiment of the invention.

[0034] In one embodiment of the system, the syringe is reversibly fluidly connected to the port. This embodiment is the eleventh embodiment of the invention, which preferably depends on the tenth embodiment of the invention.

[0035] One embodiment of the system includes a device according to one of the sixth to eighth embodiments of the invention, particularly a device comprising compartments having substantially equal volumes, wherein such an amount of liquid component is stored in a tank, and after the tank has been opened, all compartments of the reservoir can be filled with the liquid component, and in this case, have a filling level that at least segmentally protrudes beyond the height of at least one partition wall separating the compartments. This embodiment is the twelfth embodiment of the invention, which preferably depends on the ninth to eleventh embodiments of the invention.

[0036] In one embodiment of the system, the filling level of the compartment protrudes at least segmentally beyond the height of the partition wall by a maximum of 1 mm. This embodiment is the thirteenth embodiment of the invention, which preferably depends on the twelfth embodiment of the invention.

[0037] In one embodiment of the system, substantially equal amounts of powder components are stored in the syringe. This embodiment is the fourteenth embodiment of the invention, which preferably depends on embodiments nine through thirteen of the invention.

[0038] A fifteenth embodiment of the present invention is a method for providing bone cement boluses from two starting components using a system according to one of the ninth to fourteenth embodiments of the present invention, wherein the plurality of syringes includes at least a first syringe and a second syringe, the method comprising the following steps:

[0039] a. Open the storage tank using an opening device.

[0040] b. To allow the liquid components to flow from the open tank to the reservoir.

[0041] c. A first portion of the liquid component is transferred from the reservoir to the first syringe.

[0042] d. A second portion of the liquid component is transferred from the reservoir to the second syringe.

[0043] In one embodiment of the method, the system includes a first port and a first conductive device for fluidly connecting the first port to the reservoir; and a second port and a second conductive device for fluidly connecting the second port to the reservoir, wherein a first portion of the liquid component is delivered from the reservoir to the first syringe via the first port, and a second portion of the liquid component is delivered from the reservoir to the second syringe via the second port. This embodiment is the sixteenth embodiment of the invention, which preferably depends on the fifteenth embodiment of the invention.

[0044] In one embodiment of the method, the reservoir includes a first compartment and a second compartment, wherein after the reservoir has been opened, a first portion of the liquid component flows into the first compartment, and a second portion of the liquid component flows into the second compartment. The first compartment is fluidly connected to the first port via a first connecting device, and the second compartment is fluidly connected to the second port via a second connecting device. The first portion of the liquid component is delivered from the first compartment to the first syringe, and the second portion of the liquid component is delivered from the second compartment to the second syringe. This embodiment is the seventeenth embodiment of the invention, which preferably depends on the sixteenth embodiment of the invention.

[0045] General

[0046] In this specification, the range specification also includes values ​​designated as limits. The indication "within the range of X to Y" relative to the type of variable A means that A can assume values ​​X, Y, and values ​​between X and Y. Therefore, the range "up to Y" defined on one side of the type of variable A correspondingly means Y and values ​​less than Y.

[0047] Some of the characteristics described relate to the term "substantially". The term "substantially" should be understood to mean that, under actual conditions and manufacturing techniques, the precise mathematical interpretation of terms such as "overlapping", "perpendicular", "diameter", or "parallelism" may never be given precisely, but can only be applied within certain manufacturing-related tolerances. For example, "substantially parallel axes" includes angles of 85 to 95 degrees relative to each other, and "substantially equal volumes" includes a deviation of at most 5% by volume. "Equipment composed substantially of plastic material" includes, for example, a plastic content of ≥95% by weight to ≤100% by weight. "Substantially completely filling volume B" includes, for example, filling ≥95% by volume to ≤100% by volume of the total volume B. Detailed Implementation

[0048] The first subject of the present invention relates to an apparatus for providing a liquid component as a first starting component of a bone cement bolus from two starting components, the apparatus comprising: a receiving container in which a tank containing the liquid component is stored; and an opening device for opening the tank.

[0049] A reservoir fluidly connected to the receiving container for receiving the liquid component from the reservoir; at least one port for fluidly connecting the device to a syringe in which a powder component can be stored as a second starting component of the bone cement clump; and at least one connecting device for fluidly connecting the reservoir and the at least one port to each other.

[0050] The device includes a receiving container in which a tank can be stored containing the liquid components of the bone cement bolus. The term "tank" is understood to refer to any container that can store the liquid components in a sealed and aseptic manner and can be broken by manual force. Examples of tanks are glass ampoules, plastic ampoules, and plastic bags. Glass ampoules are preferred because they are easy to sterilize and easy to open by manual force.

[0051] A receiving container is understood to mean a container for the equipment, particularly a tubular container, suitable for securely storing the tank. The receiving container preferably comprises a tank, particularly preferably a glass ampoule, so that the tank is reliably secured against common sudden movements, for example, when transporting the equipment. For this purpose, a cushioning element, for example made of foam, may be attached inside the receiving container, which reduces the risk of the tank opening undesirably (e.g., due to breakage during transport).

[0052] To open a storage tank, the equipment includes an opening device. An opening device is understood to mean a means adapted to breach the structural integrity of the storage tank and thus open it. The implementation of the opening device is selected based on the type and structural stability of the storage tank. For example, if the container is a plastic bag, the opening device preferably includes elements suitable for cutting, piercing, or tearing the plastic bag, such as a sharp point and / or cutting edge. For example, if the container is a glass ampoule, the opening device includes or is, for example, a point, cutting edge, or severing edge.

[0053] The container is preferably a glass ampoule, and therefore preferably, the opening device comprises or is composed of bevels, the glass ampoule being stored such that it can be pushed against said bevel to be opened. The glass ampoule typically has an ampoule head connected to the ampoule body via an ampoule neck. The ampoule head can preferably be separated by pushing against the bevel, allowing the liquid components to flow from the reservoir through the thus opened ampoule neck.

[0054] In one embodiment, the ramp is designed as a separate component arranged within the equipment. In another embodiment, the ramp is designed as a section of the equipment wall, particularly an inner wall, especially a section of the wall of a container or storage unit. This reduces the number of equipment components and thus lowers the risk of equipment failure and its production costs.

[0055] To push a storage tank, particularly a glass ampoule, against an inclined plane and thus open it, the device, particularly the receiving container, can be designed in various ways. In one embodiment, the receiving container can be pushed into the device, at least in sections, to push the storage tank against the inclined plane. For example, the container may include a rear receiving section that can be inserted, at least in sections, into a front receiving section facing the opening device to open the storage tank. In another embodiment, the container, or at least a portion thereof, may be flexible so that the storage tank can be pushed against the opening device, which is particularly inclined, by means of rotational movement relative to the opening device, and thus open the storage tank. To prevent accidental opening of the storage tank, the device may be designed with a transport stabilizing device that prevents insertion or bending of the receiving container until it is removed by the user of the device before use.

[0056] To facilitate the flow of liquid components from the tank, particularly in the form of glass ampoules, the receiving container is preferably designed such that, after the tank is opened, the tank forms an angle of 10° to 30°, preferably 15° to 25°, with respect to the perpendicular of the surface when the equipment is properly set on a horizontal surface (e.g., a platform).

[0057] The receiving container of the equipment is fluidly connected to the reservoir. In this case, the receiving container and the reservoir can be designed to be directly fluid-conducting to each other, or a fluid-conducting element (e.g., a pipe or tube) is arranged between the receiving container and the reservoir to create a fluid connection. The reservoir is used for the uncontaminated, substantially sterile intermediate storage of the liquid component, from which the liquid component flows after the reservoir is opened until it is mixed with the powdered component, which is the second starting component of the bone cement lumps. The reservoir stores the liquid component in a uncontaminated manner and, when methyl methacrylate is used as the liquid component, is also substantially odorless to the user of the equipment, allowing the liquid component to be easily, quickly, and quantitatively removed as a whole or in multiple parts as needed for mixing the bone cement lumps. This allows for time-shifted mixing of multiple portions of the bone cement lumps. Therefore, only the currently required amount of bone cement lumps can always be supplied for use, and only subsequent portions of the bone cement lumps from the same reservoir of the liquid component are mixed. Therefore, the entire processing time of the bone cement mass used for each of these parts is available to the surgeon, which would not be possible if the entire tank were initially mixed.

[0058] In this case, the size of the reservoir is preferably set so that the liquid component can be completely stored within the reservoir. For example, the reservoir holds a liquid volume of up to 50 ml.

[0059] To receive liquid components, the reservoir can be designed in different ways. In one embodiment, the reservoir is designed as a shell to significantly reduce the complexity of the equipment. In this case, the reservoir preferably includes a reservoir opening that fluidly opens and faces the receiving container. This allows the liquid components to flow easily from the tank into the shell-like reservoir via the reservoir opening facing the receiving container.

[0060] When the equipment is properly set on a horizontal surface, the reservoir is preferably located spatially lower than the receiving container, i.e., closer to the horizontal surface, so that the liquid components can flow from the tank to the reservoir under gravity and without user intervention.

[0061] To prevent tank fragments or fragments from entering the storage container after the tank has been opened, particularly to prevent glass fragments from entering the storage container after a tank in the form of glass ampoules has been opened, a retaining element may be arranged between the receiving container and the storage container. The retaining element may include, for example, a sieve, a perforated plate (especially a perforated plastic plate), or a perforated pin (especially a perforated plastic pin), or a combination of the above.

[0062] In order to deliver liquid components from the reservoir to the syringe for further use, the device includes at least one port that is fluidly connected to the reservoir via a conduction device.

[0063] The connecting device can be formed in different ways to fluidly connect the port and the reservoir. For example, the connecting device can be formed as a channel. The connecting device is preferably connected to the reservoir such that, when the device is correctly set up, substantially the entire liquid component present in the reservoir can be conveyed through the connecting device in the direction of the port. For example, when the device is correctly set up, the connecting device is arranged in the region of the lowest point in the space of the reservoir.

[0064] The syringe can be reversibly and fluidly connected to a reservoir via a port to deliver a liquid component temporarily stored in the reservoir into the syringe. The port can be designed in different ways to create the fluid connection between the device and the syringe. In one embodiment, the port is threaded to create a fluid connection with a corresponding counterpart on the syringe. For example, the port may include an internal thread that fluidly connects with an external thread on the syringe. In another embodiment, the port and syringe form a bayonet connection. In yet another embodiment, the port and syringe can be fluidly connected to each other by partially inserting the syringe into the port. For example, a conduit can be formed as a tube to fluidly connect the reservoir and the port, and the syringe can be fluidly connected to the port and syringe by inserting the syringe segmentally into the tube. After delivery of the liquid component, the syringe can be detached from the port for further use.

[0065] To prevent fragments from the storage tank, particularly glass fragments generated when the tank in the form of a glass ampoule is opened, from entering the syringe fluidly connected to the port, the port may be equipped with a filter unit. The filter unit may, for example, include a sieve, a perforated plate (particularly a perforated plastic plate), or a perforated pin (particularly a perforated plastic pin), or a combination thereof. In one embodiment, the port and the filter unit are irreversibly connected to each other, for example, via an adhesive. In another embodiment, the port and the filter unit are reversibly connected to each other; the filter unit is, for example, formed as an adapter that can be connected to the port. In this case, the adapter may be connected to the port, for example, via a threaded connection or a bayonet connection. The adapter may then be fluidly connected to the syringe, for example, via the side opposite to the port, such that the port is fluidly connected to the syringe via the adapter.

[0066] To prevent liquid components from accidentally flowing through at least one port into a syringe fluidly connected to at least one port, it is preferable that, when the device is properly positioned on a horizontal surface, the reservoir space is located at a lower position than at least one port, i.e., closer to the horizontal surface.

[0067] One embodiment of the device is characterized by comprising: multiple ports, particularly two, three, four, or five ports, for fluidly connecting the device to a syringe in which a powder component can be stored as a second starting component of the bone cement mass; and multiple connecting devices, particularly two, three, four, or five connecting devices, wherein one of the connecting devices fluidly connects the reservoir and one of the ports to each other in each case. The device includes multiple connecting device / port pairs to enable simultaneous fluid connection of the device to multiple syringes. Due to the multiple ports, the device can be fluidly connected to multiple syringes prior to the initial mixing of a portion of the bone cement mass, making it easier for the user to use multiple syringes during surgical procedures. Furthermore, if one port is blocked, another port can be used.

[0068] One embodiment of the device is characterized in that the reservoir is divided into multiple compartments, wherein one compartment is fluidly connected to one port via a connecting device in each case. Due to the compartments, the reservoir is divided into smaller sub-reservoirs, which allows the liquid components flowing from the reservoir to be pre-dispensed within the reservoir. Since each individual compartment is fluidly connected to a separate port via a separate connecting device, a pre-dispensed amount of liquid component can be withdrawn from the device via each of these separate ports. This ensures that only a desired, predefined amount of liquid component can be withdrawn from one port, making the device easier for the user to operate.

[0069] In one embodiment, the individual compartments have different volumes, allowing different amounts of liquid components to be withdrawn from corresponding ports of the device. This allows different portions of the cementitious clumps from the tank containing the liquid components to be mixed in a staggered manner over time. These portions may, for example, have different volumes and / or viscosities.

[0070] One embodiment of the device is characterized by individual compartments each having substantially equal volumes. This allows substantially equal portions of the cementitious lumps to be mixed alternately over time by means of individual tanks containing liquid components. These portions may have equal volumes and viscosities, for example, while using equal parts of powder components simultaneously.

[0071] To provide pre-dispensed amounts of liquid components via individual ports, the reservoir can be divided into compartments in different ways.

[0072] One embodiment of the device is characterized in that the reservoir is divided into compartments by means of at least one partition wall. For example, a single partition wall can divide the reservoir into two compartments, or two intersecting partition walls can divide the reservoir into four compartments. The partition walls allow for a simple and cost-effective construction in which the reservoir is divided into compartments.

[0073] One embodiment of the device is characterized in that the compartments are fluidly open on the upper compartment side facing the container in each case, such that the compartments are fluidly connected to each other via the upper compartment side. For example, a first partition wall can divide a container, particularly a shell-like container, including a fluidly open storage side facing the container into two compartments, each of which includes an upper compartment side fluidly open facing the container. Furthermore, the container can be divided into four compartments, for example, by a second partition wall that traverses the first partition wall, each of the four compartments correspondingly having four fluidly open upper compartment sides.

[0074] The connection device can be formed in different ways to fluidly connect the reservoir or individual compartments of the reservoir to one or more ports.

[0075] One embodiment of the device is characterized in that at least one connecting device is a pipe. The pipe allows for a simple, advantageous, and flexible fluid connection between the container and the port.

[0076] One embodiment of the device is characterized by an inner diameter of the tube ranging from 0.5 mm to 3 mm, preferably between 0.5 mm and 2.5 mm, and more preferably between 0.5 mm and 2 mm. Due to the surface tension of the liquid component, this inner diameter of the tube prevents the liquid component from flowing autonomously out of the reservoir via the flow-through device in the direction of the port. With this inner diameter of the tube, the liquid component remains within the reservoir until the user actively delivers the liquid component out of the reservoir in the direction of the port, for example by applying delivery pressure to the liquid component or by applying negative pressure via the flow-through device in the direction of the port (e.g., by actuating a syringe fluidly connected to the port).

[0077] Another subject of the invention relates to a system for providing bone cement lumps from two starting components, the system comprising the apparatus described in one of the foregoing embodiments, wherein a reservoir containing a liquid component as the first starting component, preferably in the form of a glass ampoule, is stored in a receiving container, and wherein the system comprises a plurality of syringes, particularly two, three, four or five syringes, each syringe containing a powder component as the second starting component.

[0078] Storage tanks are understood to refer to all containers that can store liquid components in a sealed and aseptic manner and can be broken by manual force. Examples of storage tanks are glass ampoules, plastic ampoules, and plastic bags. Glass ampoules are preferred because they are easy to sterilize and easy to open by manual force.

[0079] The system includes multiple syringes that contain a powdered component as a second starting component for the bone cement clump. This allows for easy and rapid mixing of the bone cement clump within one of the syringes after the liquid component has been delivered from a reservoir, a connecting device, and a port into the syringe. Therefore, it is not necessary to transfer the bone cement clump to another syringe within the syringe. To mix the bone cement clump in the syringe, the syringe may contain a mixing device, such as a mixing rod or one or more mixing balls. The mixing balls are used to mix the bone cement clump by shaking the syringe, as the mixing balls, along with the two starting components, move back and forth within the syringe by shaking, thereby supporting the mixing process.

[0080] In one implementation of the system, the syringe is not designed with a mixing device.

[0081] The syringe should be understood as a container that can store powder components in a contamination-free manner, and the bone cement clump can be applied to a desired location by means of the syringe. The syringe preferably includes a syringe piston that can expel the bone cement clump from the syringe by advancement in the direction of the syringe's discharge opening. For expelling the bone cement clump, discharge aids (such as sleeves, discharge nozzles, or tubes) can be secured to the syringe, particularly the discharge opening.

[0082] The syringe can be reversibly and fluidly connected to the port of the device. For this purpose, the syringe may include, for example, threads, particularly external threads, or may include part of a bayonet connection.

[0083] To prevent debris from the reservoir from being transferred into the syringe along with the liquid components, the syringe may include a filter. The filter may, for example, comprise a sieve, a perforated plate (particularly a perforated plastic plate), or a perforated pin (particularly a perforated plastic pin), or a combination thereof. In one embodiment, the syringe and the filter are reversibly connected to each other; the filter is, for example, formed as a syringe adapter that can be connected to the syringe. In this case, the syringe adapter may be connected to the syringe, for example, via a threaded connection or a bayonet connection. The filter is preferably removed from the syringe, for example, by unscrewing, before the bone cement clump is applied from the syringe. In another embodiment, the filter is inserted into the syringe in the area of ​​the discharge opening, and is ejected from the syringe by the bone cement clump, particularly from the discharge opening, when the bone cement clump is discharged.

[0084] The system is preferably designed such that the liquid component contained is sufficient to mix a suitable bone cement mass for surgical use in multiple, preferably all, syringes of the system. For example, the reservoir contains 30 ml of liquid component, and the multiple syringes contain a total of 45 g of powder component.

[0085] The system allows for time-shifted mixing of multiple portions from a single package (particularly by means of a single tank containing liquid components). This reduces the time pressure on surgeons who would otherwise have to use the entire initially mixed bone cement clump for the entire treatment time. The time-shifted, portion-wise mixing starts with a separate treatment time for each syringe in the syringe, resulting in a longer overall timeframe available for the use of the bone cement clump.

[0086] To prevent the liquid component from accidentally flowing through at least one port into the syringe fluidly connected to at least one port, it is preferable that, when the device is properly positioned on a horizontal surface, the reservoir is spatially located at a position lower than at least one port, i.e., closer to the horizontal surface. Furthermore, it is preferable that, when the device is properly arranged on a horizontal surface, the liquid component has a spatial level lower than at least one port after flowing into the reservoir.

[0087] One embodiment of the system is characterized by the device including multiple ports, particularly two, three, four, or five ports. Preferably, the system includes as many ports as the syringes. For example, the system includes two ports and two syringes.

[0088] This allows all syringes to be fluidly connected to the device simultaneously, even before surgery begins, making it easier for surgeons to perform procedures.

[0089] One implementation of this system features a syringe that is reversibly and fluidly connected to the port. This seals the device and syringe in a contamination-free manner, allowing the system, particularly the reservoir and powder components within it, to be stored aseptically. Specifically, this system can be removed from a sterile package, otherwise, the system (particularly the reservoir and powder components) would be at risk of contamination. Furthermore, potential surgical errors in applying the system are thus reduced.

[0090] One embodiment of the system (where the device of the system is an embodiment of the device described in the foregoing embodiments of the device, comprising a reservoir divided into a plurality of compartments by means of at least one partition wall, wherein each compartment is fluidly open on an upper compartment side facing the housing, such that each compartment is fluidly connected to each other via the upper compartment side, and wherein one of the compartments is fluidly connected to one of the ports of the device via a connecting device in each case) is characterized in that such a quantity of liquid component is stored in a tank, and after the tank has been opened, all compartments of the reservoir can be filled with the liquid component and, in each case, have a filling level that at least segmentally protrudes beyond the height of at least one partition wall separating the respective compartments.

[0091] This allows all compartments to be filled with liquid components, as the liquid components flowing from the tank into the reservoir are distributed on specific separation partition walls via the upper compartment side.

[0092] For example, a liquid component flows from the tank into only one compartment of the reservoir and fills that compartment. If the volume of that compartment is filled, additional liquid components flowing into that compartment flow from the already filled compartment across the compartment's partition wall into the adjacent compartment. In this way, the monomeric liquid can be continuously distributed into and fill all the compartments of the reservoir. In this case, the amount of liquid component is adjusted such that all compartments can be completely filled, and in each compartment, the liquid component has a filling level that is at least segmentally higher than the corresponding partition wall. This allows the filling level of the monomeric liquid to be "equalized" across all compartments. Therefore, the compartments have an excess that protrudes beyond at least one partition wall.

[0093] One embodiment of the system is characterized in that the fill level of the compartments protrudes at least segmentally beyond at least one partition wall by a height not exceeding 1 mm. In other words, the excess is no more than 1 mm. This allows the liquid component to be well distributed in all compartments. As the first compartment is drained, the excess flows into and is also drained from the first compartment. This ensures, for example, that even though the compartments are of equal size, the compartment that drains first receives the largest proportion of the liquid component. The small excess, with a maximum value of 1 mm, ensures that the compartments substantially provide the volume of liquid component predefined by the compartment, regardless of the order in which they drain.

[0094] One embodiment of the system is characterized by substantially equal amounts of powder components stored in the syringe. This prevents the risk of confusion between individual syringes, which in some cases would deliver bone cement with different properties (such as rheological properties). Furthermore, the compartments preferably have substantially equal volumes, so that each syringe can yield bone cement clumps with substantially the same properties, particularly substantially the same rheological properties.

[0095] Another subject of the invention relates to a method for providing bone cement boluses from two starting components by means of a system, particularly by means of a system according to one of the foregoing embodiments, wherein a plurality of syringes includes at least a first syringe and a second syringe, the method comprising the following steps:

[0096] a. The storage tank is opened using the opening device.

[0097] b. Allow the liquid component to flow from the open tank to the reservoir.

[0098] c. A first portion of the liquid component is transferred from the reservoir to the first syringe.

[0099] d. A second portion of the liquid component is transferred from the reservoir to the second syringe.

[0100] The storage tank can be opened in different ways, preferably by means of glass ampoules, and by pushing or rotating the glass ampoule against an opening device (preferably an inclined opening device) to open the tank. In this case, it is preferable to separate the glass ampoule head to open the storage tank.

[0101] After the tank has been opened, the liquid components flow from the opened tank into a reservoir, preferably a shell-type reservoir. Preferably, this occurs under gravity and without active intervention from the user of the system.

[0102] In order to provide the first portion of the bone cement mass, the first portion of the liquid component is delivered from the reservoir to the first syringe. The second portion of the liquid component is retained in the reservoir.

[0103] The second portion of the liquid component is delivered to the second syringe at a time offset from the delivery of the first portion of the liquid component. The remaining portion of the liquid component may remain in the reservoir and may be used to deliver it to another syringe and, in turn, to either the first or second syringe.

[0104] The delivery of liquid components to the first and second syringes can be performed in different ways. In a preferred embodiment of the method, delivery is carried out in each case via the piston stroke of the syringe piston associated with the syringe. Therefore, delivery can be performed without separate tools or equipment (such as a pump), making the method easier.

[0105] One embodiment of the method (where the system includes a first port and a first connecting device for fluidly connecting the first port to a reservoir, and a second port and a second connecting device for fluidly connecting the second port to the reservoir) is characterized in that a first portion of the liquid component is delivered from the reservoir to a first syringe via the first port, and a second portion of the liquid component is delivered from the reservoir to a second syringe via the second port. Further portions of the liquid component may be delivered via a separate port to a separate or identical syringe, the separate port being fluidly connected to the reservoir via a separate connecting device.

[0106] In this way, the first and second syringes can be fluidly connected to the device simultaneously, even before the start of surgery, making the method easier to apply. Furthermore, the system may already be aseptically packaged with the fluid-conducting syringes, reducing the risk of system contamination after removal from the aseptic packaging.

[0107] One embodiment of the method (where the reservoir includes a first compartment and a second compartment) is characterized in that, after the reservoir has been opened, a first portion of the liquid component flows into the first compartment, and a second portion of the liquid component flows into the second compartment, wherein the first compartment is fluidly connected to a first port via a first connecting device, and the second compartment is fluidly connected to a second port via a second connecting device, and the first portion of the liquid component is delivered from the first compartment to a first syringe, and the second portion of the liquid component is delivered from the second compartment to a second syringe. By means of the first and second compartments, and optionally additional compartments, the liquid component is pre-dispensed in the reservoir such that only a substantially predefined amount of liquid component is withdrawn from the device via the port. Therefore, the user of the system does not need to be aware of how much liquid component is delivered to a particular syringe, which reduces the risk of incorrectly metered withdrawal of the liquid component.

[0108] Bone cement clumps are understood to refer in the field of medical technology to a substance suitable for forming a stable connection between artificial joints (such as hip and knee joints) and bone material and / or for stabilizing vertebral bodies. Through curing, bone cement clumps become bone cement. These bone cements are preferably polymethyl methacrylate (PMMA) bone cement or inorganic bone cement.

[0109] PMMA bone cement has been used in medical applications for a long time, based on Sir Charnley's article (see Charnley, J., "Anchorage of the femoral headprosthesis of the shaft of the femur," *Journal of Bone Joint Surg.*, 1960; Vol. 42, pp. 28-30). In this case, PMMA bone cement can be produced from a powder component comprising bone cement powder as a first starting component and a liquid component comprising monomer liquid as a second starting component. With a suitable composition, the two starting components can be stored separately and stably. When the two starting components are brought into contact with each other, a plastically deformable bone cement mass is produced by the swelling of the polymer component of the bone cement powder. In this case, polymerization of the monomers is initiated by free radicals. As the polymerization of the monomers continues, the viscosity of the bone cement mass increases until it is completely cured.

[0110] Bone cement powder is understood to mean a powder comprising at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer. Examples of copolymers are styrene and / or methyl acrylate. In one embodiment, the bone cement powder may additionally contain a hydrophilic additive that supports the distribution of monomer liquid within the bone cement powder. In another embodiment, the bone cement powder may additionally contain an initiator for initiating polymerization. In yet another embodiment, the bone cement powder may additionally contain a radiopaque material. In still another embodiment, the bone cement powder may additionally contain a pharmaceutically active substance, such as an antibiotic.

[0111] Bone cement powder preferably comprises at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer, an initiator, and a radiopaque material as a hydrophilic additive, or is composed of these components. More preferably, bone cement powder comprises at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer, an initiator, a radiopaque material, and a hydrophilic additive, or is composed of these components. Most preferably, bone cement powder comprises at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer, an initiator, a radiopaque material, a hydrophilic additive, and an antibiotic, or is composed of these components.

[0112] According to the present invention, the particle size of the bone cement powder of particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer can correspond to a sieve particle size of less than 150 μm, preferably less than 100 μm.

[0113] According to the present invention, the hydrophilic additive may be designed in particulate and / or fibrous form. In another embodiment, the hydrophilic additive may be slightly soluble in methyl methacrylate, preferably insoluble. In another embodiment, the hydrophilic additive may have an absorption capacity of at least 0.6 g of methyl methacrylate per gram of hydrophilic additive. In another embodiment, the hydrophilic additive may comprise a chemical substance containing at least one OH group. In this case, the hydrophilic additive may preferably have covalently bonded OH groups on its surface. Examples of such preferred hydrophilic additives may be additives selected from the group consisting of cellulose, oxidized cellulose, starch, titanium dioxide, and silica, wherein pyrogenic silica is particularly preferred. In one embodiment, the particle size of the hydrophilic additive may correspond to a sieve particle size of less than 100 μm, preferably less than 50 μm, and most preferably less than 10 μm. Based on the total weight of the bone cement powder, the amount of hydrophilic additive may be from 0.1% to 2.5% by weight.

[0114] According to the present invention, the initiator may contain benzoyl peroxide or be composed of benzoyl peroxide.

[0115] According to the present invention, radiopaque material is understood to mean a substance that makes bone cement visible on diagnostic X-ray images. Examples of radiopaque materials may include barium sulfate, zirconium dioxide, and calcium carbonate.

[0116] According to the present invention, the pharmaceutically active substance may include one or more antibiotics and optionally added cofactors for the one or more antibiotics. Preferably, the pharmaceutically active substance consists of one or more antibiotics and optionally added cofactors for the one or more antibiotics. Examples of antibiotics particularly include gentamicin, clindamycin, and vancomycin.

[0117] According to the present invention, the monomeric liquid may comprise or consist of methyl methacrylate monomer. In one embodiment, in addition to the monomer, the monomeric liquid also comprises an activator (such as N,N-dimethyl-p-toluidine) dissolved therein or consists of methyl methacrylate and N,N-dimethyl-p-toluidine.

[0118] Inorganic bone cement is understood to refer to bone cement based on calcium phosphate and calcium sulfate dihydrates. In this case, powders of calcium phosphate and / or calcium sulfate dihydrates, which can be cured from liquid components containing aqueous solutions of different salts, can be used as powder components. Numerous inorganic bone cements have been described, and are referred to by way of example in the following documents: EP 1 592 463B1, EP 2 271 585 B1 and EP 2 988 789 B1.

[0119] Features disclosed for devices are also disclosed for systems and methods, and vice versa.

[0120] Attached Figure

[0121] The invention is further illustrated below by way of example and with reference to the accompanying drawings. The invention is not limited to the drawings.

[0122] The attached diagram shows:

[0123] Figure 1 A schematic longitudinal section of an apparatus for providing a liquid component as the first starting component of a bone cement mass from two starting components, the apparatus comprising a tank containing the liquid component.

[0124] Figure 2 A schematic longitudinal section of a system for providing bone cement boluses, the system comprising: Figure 1 equipment Figure 1 The storage tank, the first syringe, and the second syringe.

[0125] Figure 3 With open storage tanks Figure 2 The system

[0126] Figure 4 When a portion of the liquid component is delivered into the first syringe Figure 2 and Figure 3 The system

[0127] Figure 5 The first syringe with fluid separation Figures 2 to 4 The system

[0128] Figure 6 The second syringe with fluid separation Figures 2 to 5 The system

[0129] Figure 7 A schematic longitudinal section of an additional system for providing bone cement lumps from two starting components.

[0130] Figure 8 A schematic longitudinal section of an additional system for providing bone cement lumps from two starting components, the system comprising a compartmentalized reservoir and a tank containing liquid components.

[0131] Figure 9 Figure 8 A schematic floor plan showing the details of the system, including the storage.

[0132] Figure 10 Figure 8 and Figure 9 A schematic side view of the storage device.

[0133] Figure 11 With open storage tanks Figures 8 to 10The system

[0134] Figure 12 After a portion of the liquid component is delivered into the first syringe Figures 8 to 11 The system, and

[0135] Figure 13 Flowchart of a method for providing bone cement lumps. Attached Figure Description

[0136] Figure 1 A schematic longitudinal section of an exemplary embodiment of an apparatus 100 for providing a liquid component as a first starting component of a bone cement bolus from two starting components is shown. The apparatus 100 includes a tubular receiving container 110 in which a reservoir 300 containing liquid component 350 as the first starting component of the bone cement bolus is stored. The reservoir 300 is a glass ampoule, including an ampoule head 310 connected to an ampoule body 330 via an ampoule neck 320. The receiving container 110 includes the reservoir 300 in a sleeve manner, allowing for secure transport within the apparatus 100. The receiving container 110 is directly fluidly connected to a shell-formed reservoir 500. To open the storage tank 300, the receiving container 110 includes a rear receiving section 111 that can be inserted into a front receiving section 112, such that the storage tank 300, particularly the glass ampoule body 330, is stored such that it can be pushed against an inclined opening device 200. In the illustrated embodiment, the opening device 200 is designed as part of the wall of the storage container 500.

[0137] Device 100 includes a first port 600a and a second port 600b, through which device 100 can be reversibly fluidly connected to a syringe, particularly to two syringes simultaneously, especially by screwing them together. The first port 600a is fluidly connected to a reservoir 500 via a first connecting device 550a, and the second port 600b is fluidly connected to the reservoir via a second connecting device 550b. The two connecting devices 550a and 550b are designed as two separate tubes, forming separate passageways to the reservoir.

[0138] Figure 2 A system 700 for providing bone cement lumps from two starting components is shown, comprising: Figure 1 The device 100 is filled with liquid component 350 as the first starting component of the bone cement mass. Figure 1The device includes a storage tank 300 and a first syringe 650a and a second syringe 650b. Syringes 650a and 650b contain powder component 400 as a second starting component for the bone cement clump and are each equipped with a syringe piston 670a and 670b, which is stored so as to be reversibly displaced along the longitudinal axis of syringes 650a and 650b. Syringes 650a and 650b are also each equipped with a fluid-conducting filter 660a and 660b, allowing fluid, particularly gaseous and liquid component 350, but not solid, particularly powder component 400, and / or a portion of the storage tank 300, to be exchanged between syringes 650a and 650b and the device 100 via conduction devices 550a and 550b. The first syringe 650a is reversibly fluidly connected to the device 100 via the first port 600a, and the second syringe 650b is reversibly fluidly connected to the device via the second port 600b, wherein syringes 650a and 650b are threaded to ports 600a and 600b.

[0139] Figure 3 It shows Figure 2 System 700, which is related to Figure 2 In contrast, the rear receiving section 111 is inserted segmentally into the front receiving section 112. By inserting the rear receiving section 111 into the front receiving section 112, the tank head 310 is pushed against the opening device 200 and thus broken, thereby allowing the liquid component 350 to flow into the reservoir 500. To facilitate the flow of the liquid component 350 from the tank 300, the tank is arranged in the receiving container 110 at an angle of approximately 20° to the perpendicular of the device 100. Due to the surface tension of the liquid component 350, the liquid component 350 remains in the reservoir 500 and does not flow autonomously in the direction of the syringes 650a and 650b via the connecting devices 550a and 550b. Therefore, the liquid component 350 is temporarily stored in the reservoir 500 in a contamination-free manner and can be introduced into the syringes 650a and 650b as needed and in a time-independent and time-shifted manner.

[0140] Figure 4 It shows Figure 2 and Figure 3 System 700, which is related to Figure 2In contrast, a portion of the liquid component 350 has already been delivered from the reservoir 500 to the first syringe 650a via the first conduction device 550a. To deliver the liquid component 350, the syringe piston 670a of the first syringe 650a is partially pulled out from the axially opposite end of the first syringe 650a, whereby a negative pressure in the first syringe 650a causes this portion of the liquid component 350 to be delivered from the reservoir 500. The further the syringe piston 670a of the first syringe 650a is pulled out, the more liquid component 350 is delivered into the first syringe 650a. To determine the amount of liquid component 350 delivered, the user of the system can read a scale, for example, from the outside (not shown) of the first syringe 650a. In another embodiment not shown, system 700 includes a piston stroke adjuster located on syringes 650a, 650b, such that in order to deliver liquid component 350 from reservoir 500, syringe pistons 670a, 670b can be pulled out of syringes 650a, 650b only to a maximum predefined height. The piston stroke adjuster allows a predetermined amount of liquid component 350 to be delivered into syringes 650a, 650b without requiring the user of system 700 to read the scale. The piston stroke adjuster can be adapted to the amount of powder component 400 in syringes 650a, 650b, such that bone cement clumps with desired rheological properties can be provided in syringes 650a, 650b.

[0141] Figure 5 It shows Figures 2 to 4 System 700, which is related to Figure 4 In contrast, the first injector 650a has been fluidly separated from the device 100. In the first injector 650a, bone cement clump 450 has been formed from the two starting components by agitating the first injector 650a; this bone cement clump is usable within its processing cycle. Also located within the first conduit 550a is a residue of liquid component 350, which was not delivered to the first injector 650a. Located in the reservoir 500 is the remaining portion of liquid component 350, which can be delivered to the second injector 650b at any time via the second conduit 550b. Delivery of liquid component 350 to the second injector 670b can be performed in the same manner as delivery to the first injector 650a.

[0142] Figure 6 It shows Figures 2 to 5 The system 700, in which the first syringe 650a is no longer shown. Figure 6 In, with Figure 5In contrast, a further portion of the liquid component 350 is delivered from the reservoir 500 to the second syringe 650b via the second connecting device 550b and the second port 600b. The second syringe 650b is then fluidly separated from the second port 600b, and the two initial components in the second syringe 650b are mixed by agitation to form a bone cement clump 450. The bone cement clump 450 provided in the second syringe 650b can be delivered independently of the bone cement clump 450 provided in the first syringe 650a (see [link to original text]). Figure 5 The system 700 is used within the processing cycle of the bone cement clump 450. The processing cycles of the bone cement clump 450 in the two syringes 650a, 650b of the system 700 do not begin simultaneously. Therefore, the system 700 allows for the provision of a second portion of the bone cement clump 450, which can be temporarily used independently of each other. In a further embodiment not shown, the system 700 may include more than two ports 600a, 600b and more than two syringes 650a, 650b to provide more than two portions of the bone cement clump 450.

[0143] Figure 7 This is a schematic longitudinal section of another exemplary embodiment of a system 700' for providing bone cement lumps from two starting components. The system includes a device 100', a tank 300' containing a liquid component 350' as a first starting component, and a first syringe 650a' and a second syringe 650b' containing a powder component 400' as a second starting component. The embodiment of system 700' largely corresponds to the above and Figures 2 to 6 The illustrated implementation scheme is shown, and therefore, to avoid repetition, reference is made to the description above. For Figures 2 to 6 The modifications to the illustrated implementation scheme have the same reference symbols with additional apostrophes.

[0144] On the receiving container 110', particularly the rear receiving section 111', the device 100' includes a transport stabilizing device that prevents the rear receiving section 111' from being inserted into the front receiving section 112'. This ensures, for example, that the storage tank 300' will not be accidentally opened during transport of the system 770'. The transport stabilizing device 113 surrounds the receiving container 110' in a sleeve manner and can be removed by simply pulling the transport stabilizing device to allow the rear receiving section 111' to be inserted into the front receiving section 112'.

[0145] and Figures 2 to 6Compared to the two syringes 650a and 650b of system 700, the two syringes 650a' and 650b' of system 700' do not include filters 660a and 660b. Instead, device 100' is equipped with fluid-conducting filter units 610a and 610b in the form of adapters, which can be attached to the two ports 600a' and 600b'. The filter units 610a and 610b are arranged between the syringes 650a' and 650b' and the ports 600a' and 600b', so that gaseous and liquid components 350' can be delivered from reservoir 500' to syringes 650a' and 650b', while solid components such as powder components 400' or portions of reservoir 300' cannot pass through. System 700' is used to provide bone cement boluses, particularly the second portion of the bone cement bolus, which largely corresponds to... Figures 2 to 6 The use of System 700.

[0146] Compared to the previous figure, Figure 7 A reservoir conduit 505 is shown that fluidly connects the reservoir 500 and the first connecting device 550a'. This reservoir conduit 505 also connects the second connecting device 550b' of the system 700' and... Figures 1 to 6 The device 100 has two conducting devices 550a and 550b (not shown in each case).

[0147] Figure 8 A schematic longitudinal section is shown of another exemplary embodiment of a system 700″ for providing bone cement clumps from two starting components. The embodiment of system 700″ largely corresponds to that described above and Figures 2 to 6 and Figure 7 The illustrated implementation scheme is shown, and therefore, to avoid repetition, reference is made to the description above. For Figures 2 to 6 or Figure 7 The modifications to the illustrated implementation scheme have the same reference symbols with two apostrophes.

[0148] Compared to the above embodiment, in addition to the first port 660a″ and the second port 600b″, system 700″ includes a third port 600c, which is fluidly connected to the reservoir 500″ via a third connection device 550c. The third connection device 550c is designed to be separate from the other two connection devices 550a″ and 550b″. The third port 600c is reversibly fluidly connected to a third injector 650c, which, like the two other injectors 650a″ and 650b″, contains the powder component 400″ and is equipped with a fluid flow filter 660c to prevent solids, particularly the powder component 400″ and / or portions of the reservoir 300″, from passing between the third injector 650c and the device 100″. The third injector 650c includes an injector piston 670c, which is axially displaceable within the third injector 650c.

[0149] Between the storage tank 300′ and the storage container 500″, an opening device 200″ in the form of an inclined plane is arranged in the receiving container 110″, particularly in the front receiving section 112″, wherein, compared with the aforementioned embodiment, the opening device is not designed as part of the storage container 500″.

[0150] The storage device 500″ is divided into three compartments 510a, 510b, and 510c, in which... Figure 8 Of the three compartments 510a, 510b, and 510c, only the first compartment 510a is visible. Each of the compartments 510a, 510b, and 510c is fluidly connected to one of the ports 600a″, 600b, and 600c. The first compartment 510a is fluidly connected to the first port 600a″ via a first connecting device 550a″, and the second compartment 510b... Figure 8 Not shown in the image; see example. Figure 9 or Figure 10 ) is fluidly connected to the second port 600b" via the second conducting device 550b″, and the third compartment 510c ( Figure 8 Not shown in the image; see example. Figure 9 or Figure 10 The third port 600c is fluidly connected via a third connecting device 550c. For this purpose, each compartment 510a, 510b, 510c includes a compartment conduit 515 that leads to the associated connecting device 550a″, 550b″, 550c and thus creates a fluid connection (only the compartment conduit 515 of the first compartment 510a is visible).

[0151] Figure 9 It is a plan view including the storage unit 500" along the longitudinal axis of the system 700″. Figure 8Details of the system 700″. In each case, the first compartment 510a is separated from the second compartment 510b and the third compartment 510c by a partition wall 520. In each case, the individual compartments 510a, 510b, and 510c are fluidly connected to the corresponding connecting devices 550a″, 550b″, and 550c″ by one of the compartment pipes 515.

[0152] Figure 10 It shows Figure 8 and Figure 9 A perspective side view of a reservoir 500″ of a system 700″, the reservoir being divided into compartments 510a, 510b, and 510c. Two partition walls 520 separating compartments 510a, 510b, and 510c each have a height 521 (marked only for the partition walls separating the first compartment 510a and the second compartment 510b), which together define the volume of each individual compartment 510a, 510b, and 510c. The individual compartments 510a, 510b, and 510c have substantially equal volumes, such that an equal amount of liquid component 350″ (unmarked) can be stored in each compartment 510a, 510b, and 510c. In the illustrated embodiment of the reservoir 500″, the height 521 of the partition wall 520 is not constant across the entire extension of the respective partition wall 520. In another embodiment, not shown, the height 521 of the partition wall 520 is constant across the entire extension. Compartments 510a, 510b, and 510c each include fluidly open upper compartment sides 511a, 511b, and 511c, which face towards... Figure 8 The receiving container 110″, and the liquid component 350″ can be used. Figure 8 After the storage tank 300″ has been opened, the water flows through the upper compartment side.

[0153] Figure 11 It shows Figures 8 to 10 System 700″, which is related to Figure 8 In contrast, the later receiving segment 111' has already been removed. Figure 8 The transport stabilizing device 113″ is then inserted segmentally into the front receiving section 112′, thereby pushing the tank 300″ against the opening device 200″ and thus fluidly opening it. Liquid component 350″ has flowed from the tank 300″, specifically through… Figure 10 The upper compartment sides 511a, 511b, 511c flow into the reservoir 500″ and have already filled compartments 510a, 510b, 510c (shown only for the first compartment 510a). The amount of liquid component 350″ is selected such that, in this case, compartments 510a, 510b, 510c have a height 521 that at least segmentally protrudes beyond the partition wall 520 (see...). Figure 10The filling level is 522. Therefore, compartments 510a, 510b, and 510c have an excess of liquid component 350″ that overflows the upper compartment sides 511a, 511b, and 511c. This excess allows for uniform filling of all compartments 510a, 510b, and 510c, making it irrelevant whether the liquid component 350″ from the tank 300″ flows uniformly into all compartments 510a, 510b, and 510c or only unevenly into the first compartment 510a. The excess liquid component ensures that the filling level of each individual compartment 510a, 510b, and 510c is adapted, since compartments 510a, 510b, and 510c are fluidly connected to each other via the upper compartment sides 511a, 511b, and 511c.

[0154] The filling level 522 of compartments 510a, 510b, and 510c is 1 mm higher than the height of the partition wall 520, so that substantially equal amounts of liquid component 350″ can be delivered in each of syringes 650a″, 650b″, and 650c.

[0155] Figure 12 It shows Figures 8 to 11 System 700″, which is related to Figure 11 In contrast, by partially axially pulling the syringe piston 670a″ out of the first syringe 650a″, liquid component 350″ (not visible) is delivered from the first compartment 510a into the first syringe 650a″ via the first connecting device 550a″ and the first port 600a″. This forms a bone cement clump 450″ from the two starting components in the first syringe 650″. Liquid component 350″ remains in the second compartment 510b and the third compartment 510c at a fill level 522, which corresponds to the lowest height 521 of the partition wall 520 (not shown). This allows for a time-shifted delivery of the bone cement clump 450″ in the second syringe 650b″ and the third syringe 650c, which have the aforementioned advantages, compared to the delivery in the first syringe 650a″.

[0156] Figure 13 It is used by means of, according to Figures 2 to 6 , Figure 7 and Figures 8 to 12 The flowchart of the method 800 for providing bone cement blocks 350, 350', 350″ in systems 700, 700', 700″ includes steps 810 to 840.

[0157] In step 810, the storage tanks 300, 300', and 300'" stored in the receiving containers 110, 110', and 110'" are opened by means of the opening devices 200, 200', and 200'". Preferably, the storage tanks 300, 300', and 300'" are opened by inserting the rear receiving sections 11, 111', and 111'" into the front receiving sections 112, 112', and 112'". This pushes the storage tanks 300, 300', and 300'", preferably in the form of glass ampoules, against the opening devices 200, 200', and 200'", preferably in the form of inclined planes, and thereby opens them.

[0158] In step 820, after the tanks 300, 300', 300″ have been opened, liquid components 350, 350', 350″ flow out of the tanks and into reservoirs 500, 500', 500″. In one embodiment of method 800, liquid component 350″ flows into reservoir 500″, which is divided into separate compartments 510a, 510b, 510c. This allows for the pre-dispensing of liquid component 350″ within reservoir 500″ and makes it easier for the user of method 800 to perform part-by-part and time-shifted mixing of the bone cement clump 450″.

[0159] In step 830, a first portion of the liquid components 350, 350′, 350″ is delivered from the reservoir to the first syringes 650a, 650a′, 650a″.

[0160] In one embodiment, delivery 830 occurs from the first compartment 510a to the first syringes 650a, 650a′, 650a″.

[0161] Following step 830, a first portion of bone cement clumps 450, 450', 450'' can be provided in the first syringes 650a, 650a', 650a''' by mixing the two starting components. Preferably, for example, the first syringes 650a, 650a', 650a''' are not designed with a mixing device and the provision can be performed without mechanical action but by shaking the first syringes 650a, 650a', 650a''''. After the bone cement clumps 450, 450', 450''''''''''''''''''''''''''''''''''''''''''''''''''""""' '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''"""'"'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''" ...'

[0162] After a time offset, such as after the processing time of the bone cement clumps 450, 450', 450' in the first syringes 650a, 650a', 650a'″ expires or after the bone cement clumps 450, 450', 450'″ in the first syringes 650a, 650a', 650a'″ are consumed, and independently of step 830, in step 840 a second portion of the liquid components 350, 350', 350'″ is delivered from the reservoir to the second syringes 650b, 650b', 650b'″.

[0163] In one embodiment, delivery 840 occurs from the second compartment 510b to the second syringes 650a, 650a′, 650a″.

[0164] Following step 840, a second portion of the bone cement clumps 450, 450', 450'' in the second syringes 650b, 650b', 650b''' can be provided by mixing the two starting components. Preferably, the second syringes 650b, 650b', 650b''' are not designed with a mixing device and can be provided without mechanical action but by, for example, shaking the second syringes 650b, 650b', 650b'''. After the bone cement clumps 450, 450', 450'''' are provided in the second syringes 650b, 650b', 650b''''', the processing time for the bone cement clumps 450, 450', 450'''' begins. The bone cement clumps 450, 450', 450''''' are preferably used during this processing time.

[0165] Method 800 allows for the partial provision of bone cement clumps 450, 450', 450'', which represents a simplification for the user of the method. Specifically, due to the specific processing times of the bone cement clumps 450, 450', 450'' used, the time pressure on the user for performing Method 800 is reduced. This allows for a wider selection of different compositions of the bone cement clumps 450, 450', 450''. Furthermore, the method enables more resourceful use of individual tanks 300, 300', 300'' of the liquid components 350, 350', 350''.

[0166] Figure Labels

[0167] 100, 100′, 100″ equipment

[0168] 110, 110′, 110″ (Collect container)

[0169] 111, 111′, 111″ Receiving segment

[0170] 112, 112′, 112″ forward receiving sections

[0171] 113, 113″ Transport stabilizing device

[0172] 200, 200′, 200″ Open the device

[0173] 300, 300′, 300″ storage tanks

[0174] 310 Glass Ampoule Head

[0175] 320 Glass Ampoule Neck

[0176] 330 Glass Ampoule Body

[0177] 350, 350′, 350″ Liquid components

[0178] 400, 400′, 400″ Powder composition

[0179] 450, 450′, 450″ bone cement clumps

[0180] 500, 500′, 500″ storage

[0181] 505 Storage Pipeline

[0182] 510a First compartment

[0183] 510b Second Compartment

[0184] 510c Third compartment

[0185] 511a, 511b, 511c Upper compartment side

[0186] 515 Compartment Piping

[0187] 520 partition wall

[0188] 521 Height of the partition wall

[0189] 522 Fill Level

[0190] 550a, 550a′, 550a″ First Conducting Device

[0191] 550b, 550b′, 550b″ Second Conductor

[0192] 550c Third Conductor

[0193] 600a, 600a′, 600a″ First Port

[0194] 600b, 600b', 600b'" Second Port

[0195] 600c Third Port

[0196] 610a and 610b filter units

[0197] 650a, 650a′, 650a″ First syringe

[0198] 650b, 650b′, 650b″ Second syringe

[0199] 650c Third Syringe

[0200] 660a and 660b filters

[0201] 660a″, 660b″, 660c

[0202] 670a and 670b syringe pistons

[0203] 670a′, 670b′

[0204] 670a″, 670b″, 670c

[0205] 700, 700′, 700″ system

[0206] 800 Method for providing bone cement clumps

[0207] 810 Open

[0208] 820 Flow

[0209] 830 First Conveyor

[0210] 840 Second Conveyor

Claims

1. An apparatus (100, 100, 100') for providing liquid components (350, 350', 350'') from two starting components as a first starting component of bone cement clumps (450, 450', 450''), said apparatus comprising: A receiving container (110, 110´, 110´´), wherein the receiving container is capable of storing a tank (300, 300´, 300´´) containing the liquid component (350, 350´, 350´´). Opening device (200, 200´, 200´´), the opening device being used to open the storage tank (300, 300´, 300´´). A reservoir (500, 500´, 500´´), fluidly connected to the receiving container (110, 110´, 110´´), for receiving the liquid component (350, 350´, 350´´) from the tank (300, 300´, 300´´). At least one port (600a, 600b, 600a', 600b', 600a'', 600b'', 600c) is provided for fluidly connecting the device (100, 100', 100'') to a syringe (650a, 650b, 650a', 650b', 650a'', 650b'', 650c), the syringe being capable of storing powder components (400, 400', 400'') as a second starting component of the bone cement clump (450, 450', 450''); as well as At least one conducting device (550a, 550b, 550a', 550b', 550a'', 550b'', 550c) fluidly connects the memory (500, 500', 500'') and the at least one port (600a, 600b, 600a', 600b', 600a'', 600b'', 600c) to each other. The storage unit (500´´) is divided into a plurality of compartments (510a, 510b, 510c) by means of at least one partition wall (520), and one of the compartments (510a, 510b, 510c) is fluidly connected to one of the ports (600a´´, 600b´´, 600c) via one of the connecting devices (550a´´, 550b´´, 550c).

2. The device (100, 100´, 100´´) according to claim 1, the device comprising a plurality of ports (600a, 600b, 600a´, 600b´, 600a´´, 600b´´, 600c) and a plurality of switching devices (550a, 550b, 550a´, 550b´, 550a´´, 550b´´, 550c), wherein one of the plurality of switching devices (550a, 550b, 550a´, 550b´, 550a´´, 550b´´, 550c) in each case connects the memory (500, 500´, 500´´) and the plurality of ports (600a, 600b, 600a´, 600b´, 600c) to the storage device (500, 500´, 500´´). One of the ports in 600a´´, 600b´´, 600c) is fluidly connected to each other.

3. The device (100´´) according to claim 1, wherein each of the plurality of compartments (510a, 510b, 510c) has substantially equal volume.

4. The device (100´´) according to claim 1, wherein the plurality of compartments (510a, 510b, 510c) are fluidly open in each case at the upper compartment side (511a, 511b, 511c) facing the receiving container (110´´), such that the plurality of compartments (510a, 510b, 510c) are fluidly connected to each other via the upper compartment side (511a, 511b, 511c).

5. The device (100, 100´, 100´´) according to any one of the preceding claims, wherein the at least one conducting device (550a, 550b, 550a´, 550b´, 550a´´, 550b´´, 550c) is a tube.

6. The device (100, 100', 100'') according to claim 5, wherein the tube has an inner diameter in the range of 0.5 mm to 3 mm.

7. A system (700, 700, 700') for providing bone cement lumps (450, 450', 450'') from two starting components, the system comprising a device (100, 100', 100'') according to any one of claims 1 to 6, wherein a reservoir (300, 300', 300'') containing a liquid component (350, 350', 350'') as the first starting component is stored in the receiving container (110, 110', 110''), and the system comprising a plurality of syringes (650a, 650b, 650a', 650b', 650a'', 650b'', 650c), each syringe containing a powder component (400, 400', 400'') as the second starting component.

8. The system (700, 700´, 700´´) of claim 7, wherein the device (100, 100´, 100´´) includes a plurality of ports (600a, 600b, 600a´, 600b´, 600a´´, 600b´´, 600c), and the number of ports (600a, 600b, 600a´, 600b´, 600a´´, 600b´´, 600c) corresponds to the number of syringes (650a, 650b, 650a´, 650b´, 650a´´, 650b´´, 650c).

9. The system (700, 700', 700'') of claim 8, wherein the syringes (650a, 650b, 650a', 650b', 650a'', 650b'', 650c) are reversibly fluidly connected to the ports (600a, 600b, 600a', 600b', 600a'', 600b'', 600c).

10. The system (700´´) according to any one of claims 7 to 9, wherein the device (100´´) is the device (100´´) according to claim 4, wherein such an amount of liquid component (350´´) is stored in the tank (300´´), and after the tank (300´´) has been opened, all compartments (510a, 510b, 510c) of the reservoir (500´´) can be filled with the liquid component (350´´) and in this case have a filling level (522) that at least segmentally protrudes beyond the height (521) of the at least one partition wall (520) separating the plurality of compartments (510a, 510b, 510c).

11. The system (700´´) of claim 10, wherein the filling level (522) of the plurality of compartments (510a, 510b, 510c) protrudes at least segmentally beyond the height (521) of the partition wall by a maximum of 1 mm.

12. The system (700, 700', 700'') according to any one of claims 7 to 9, wherein substantially equal amounts of the powder components (400, 400', 400'') are stored in the syringes (650a, 650b, 650a', 650b', 650a'', 650b'', 650c).

13. A method (800) for providing bone cement clumps (450, 450', 450'') from two starting components using a system (700, 700'', 700'') according to any one of claims 7 to 12, wherein the plurality of syringes (650a, 650b, 650a', 650b', 650a'', 650b'', 650c) comprises at least a first syringe (650a, 650a', 650a'') and a second syringe (650b, 650b', 650b''), the method comprising the steps of: a. The storage tank (300, 300, 300') is opened (810) by means of the opening device (200, 200', 200''). b. Allow the liquid components (350, 350', 350'') to flow (820) from the open tank (300, 300', 300'') into the reservoir (500, 500', 500''). c. A first portion of the liquid components (350, 350', 350'') is delivered (830) from the reservoir (500, 500', 500'') into the first syringe (650a, 650a', 650a''). d. A second portion of the liquid component (350, 350´, 350´´) is delivered (840) from the reservoir (500, 500´, 500´´) into the second syringe (650b, 650b´, 650b´´).

14. The method (800) of claim 13, wherein the system (700, 700', 700'') comprises a first port (600a, 600a', 600a'') and a first conducting device (550a, 550a', 550a'') for fluidly connecting the first port (600a, 600a', 600a'') to the reservoir (500, 500', 500''), and a second port (600b, 600b', 600b'') and a second conducting device (550b, 550b', 550b'') for fluidly connecting the second port (600b, 600b', 600b'') to the reservoir (500, 500', 500''), wherein the liquid component (350, A first portion of the liquid component (350, 350') is delivered (830) from the reservoir (500, 500', 500') into the first syringe (650a, 650a', 650a') via the first port (600a, 600a', 600a'), and a second portion of the liquid component (350, 350', 350') is delivered (840) from the reservoir (500, 500', 500') into the second syringe (650b, 650b', 650b') via the second port (600b, 600b').

15. The method (800) according to claim 14, wherein the reservoir (500'') comprises a first compartment (510a) and a second compartment (510b), wherein after the reservoir (300'') has been opened, a first portion of the liquid component (350'') flows into the first compartment (510a), and a second portion of the liquid component (350'') flows into the second compartment (510b), wherein the first compartment (510a) is fluidized via the first connecting device (550a''). The first chamber (600a'') is connected to the first port (600a''), and the second chamber (510b) is fluidly connected to the second port (600b'') via the second connecting device (550b''), and a first portion of the liquid component (350'') is delivered (830) from the first chamber (510a) to the first syringe (650a''), and a second portion of the liquid component (350'') is delivered (840) from the second chamber (510b) to the second syringe (650b'').

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