Adapter for mixing system for preparing bone cement paste, and kit for preparing bone cement paste comprising adapter and mixing system

Abstract

To provide an adapter for a mixing system suitable for preparing a bone cement paste by a safe and flexible method operated either manually or with electrical assistance, furthermore, to provide a kit for preparing a bone cement paste from two starting components comprising such an adapter and a mixing system and a method for preparing a bone cement paste.SOLUTION: An adapter for a mixing system for a bone cement paste is provided, and is an adapter (100) for a mixing system for preparing a bone cement paste from two starting components, comprising a fastening element (110) for reversibly fastening the adapter to a handle (210) of the mixing system and a connecting element (120) for reversibly connecting the adapter to an electric drive device, where the adapter is designed to establish a force-transmitting connection between the electric drive device (400) and the handle, whereby a mixing rod (230) can be mechanically manipulated by using the electric drive device.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an adapter for a mixing system for preparing a bone cement paste from two starting components, comprising: a fastening element for reversibly fastening the adapter to a handle of the mixing system, the handle being designed to mix two starting components in a container of the mixing system by a mixing rod of the mixing system, thereby preparing a bone cement paste; a connecting element for reversibly connecting the adapter to the electric drive; The adapter is designed to establish a force transmission connection between the electric drive and the handle, whereby the mixing rod can be mechanically operated using the electric drive.

[0002] The invention further relates to a kit for preparing a bone cement paste from two starting components, comprising such an adapter and a mixing system, as well as a method for preparing a bone cement paste from two starting components by means of such a kit. [Background technology]

[0003] Great efforts have been made to demonstrate devices and methods for providing bone cement that allow for simple, reliable, and rapid preparation of bone cement paste. An important aspect in the provision of bone cement paste is the avoidance of entrapment of air, such as air bubbles, in the bone cement. To avoid this, several vacuum cementing systems have been described, examples of which are described in U.S. Pat. Nos. 6,033,105(A), 5,624,184(A), 4,671,263(A), 4,973,168(A), 5,100,241(A), WO 99 / 67015(A1), EP 1020167(A2), U.S. Pat. No. 5,586,821(A), EP 1016452(A2), DE 3640279(A1), WO 94 / 26403(A1), EP 1005901(A2), EP 1886647(A1) and U.S. Pat. No. 5,344,232(A).

[0004] There is a desire in the market to simplify the provision of bone cement pastes. A further development is the development of mixing systems in which both starting components are stored in separate areas of the mixing system and are not mixed together in the mixing system itself until just before cementing application. Such closed, so-called complete prepacked mixing systems are described, for example, in the following documents: EP 0,692,229 (A1), DE 10,2009,031,178 (B3), U.S. Pat. No. 5,997,544 (A), U.S. Pat. No. 6,709,149 (B1), DE 698,12,726 (T2), EP 0,796,653 (A2), and U.S. Pat. No. 5,588,745 (A).

[0005] In the above-mentioned mixing systems, the monomer liquid is mechanically mixed with the bone cement powder, for example, by a manually operable mixing rod.

[0006] The presence of a manually operable mixing rod incorporated into the mixing system provides the user with the advantage that the bone cement paste can be mixed and prepared without additional aids such as a spatula, etc. Furthermore, the mixing rod incorporated into the mixing system minimizes application errors by the user and allows the bone cement paste to be prepared under the most sterile conditions possible.

[0007] However, depending on the consistency and / or volume of the final desired bone cement paste, a manual mixing rod can require a significant amount of effort when mixing the starting components. Mechanical, and especially electrical, assistance in manipulating the mixing rod can make mixing the starting components easier for the user.

[0008] There is therefore a demand on the market for a system that is suitable for and / or can be modified to prepare bone cement pastes in the simplest, safest and at the same time flexible way possible, operated either manually or with mechanical and in particular electrical assistance, depending on the preferences of the user of the mixing system. Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present invention to at least partially overcome one or more of the drawbacks arising from the prior art.

[0010] In particular, the present invention is based on the object of providing an adapter for a mixing system for preparing bone cement paste, which adapter allows a simple, quick, safe to use and cost-effective connection between the mixing system and an electric drive, thereby making it easier to mix the starting components of the bone cement paste.

[0011] In particular, the adapter is intended to enable the simplest and fastest possible connection between the electric drive and the mixing rod of the mixing system, so that the starting components can be mixed in the mixing system. Preferably, the adapter is intended to be reversibly connectable to both the mixing system and the electric drive.

[0012] A further object of the present invention is to provide a kit for preparing bone cement paste comprising such an adapter and a mixing system capable of mixing the starting components of the bone cement paste by means of a mixing rod.

[0013] A further object of the present invention is to provide a method by which a bone cement can be prepared from two starting components, whereby at least some of the previously mentioned objects are at least partially achieved. [Means for solving the problem]

[0014] Contributions to the at least partial realization of at least one of the above-mentioned objects are made by the features of the independent claims. The dependent claims provide preferred embodiments that contribute to the at least partial realization of at least one of the objects.

[0015] A first embodiment of the invention is an adapter for a mixing system for preparing a bone cement paste from two starting components, comprising: a fastening element for reversibly fastening the adapter to a handle of the mixing system, the handle being designed to mix two starting components in a container of the mixing system by a mixing rod of the mixing system, thereby preparing a bone cement paste; a connecting element for reversibly connecting the adapter to the electric drive; The adapter is designed to establish a force transmission connection between the electric drive and the handle, whereby the mixing rod can be mechanically operated using the electric drive.

[0016] In one embodiment of the adapter, the fastening element comprises a receptacle for receiving at least 20%, preferably at least 40%, most preferably at least 60% of the surface area of ​​the handle, based on the total surface area of ​​the handle. This embodiment is a second embodiment of the invention, which is preferably dependent from the first embodiment of the invention.

[0017] In one embodiment of the adapter, the receptacle has an interior shape that is substantially complementary to the exterior shape of the handle to allow for a substantially interlocking connection of the handle to the interior of the adapter. This embodiment is a third embodiment of the present invention, which is preferably dependent on the second embodiment of the present invention.

[0018] In one embodiment of the adapter, the adapter comprises a reversibly removable closure cap designed to secure the handle within the receptacle by at least partially covering the receptacle. This embodiment is a fourth embodiment of the present invention and is preferably dependent on the second to fourth embodiments of the present invention.

[0019] In one embodiment of the adapter, the closure cap can be reversibly and removably fastened to the receptacle by a lock, a clamp, a cotter pin, and / or a hook-and-loop fastener to at least partially cover the receptacle. This embodiment is a fifth embodiment of the present invention and is preferably dependent on the fourth embodiment of the present invention.

[0020] In one embodiment of the adapter, the connecting element is arranged at an end of the adapter axially opposite the fastening element. This embodiment is a sixth embodiment of the invention, preferably dependent on any one of the previous embodiments of the invention.

[0021] In one embodiment of the adapter, the connecting element comprises a rod having, in radial cross section, a circular, square or preferably hexagonal cross section. This embodiment is a seventh embodiment of the invention and is preferably dependent on any one of the previous embodiments of the invention.

[0022] In one embodiment of the adapter, the adapter is designed such that when the adapter is fastened to the handle of the mixing system, the mixing rod of the mixing system has a common longitudinal axis with the connecting element of the adapter. This embodiment is an eighth embodiment of the present invention and is preferably dependent on any of the previous embodiments of the present invention.

[0023] A ninth embodiment of the present invention relates to a kit for preparing a bone cement paste from two starting components, comprising an adapter according to any of the first to eighth embodiments of the present invention, and a mixing system comprising a container in which a bone cement powder can be, or preferably is, stored as a first starting component, and a mixing rod axially displaceably and rotatably mounted in the container and comprising a handle accessible from outside the container, for rotating the mixing rod inside the container and thus preparing the bone cement paste.

[0024] In one embodiment of the kit, the mixing system comprises a reservoir in which a monomer liquid can be, and preferably is, stored as the second starting component. This embodiment is a tenth embodiment of the present invention, which is preferably dependent from the ninth embodiment of the present invention.

[0025] An eleventh embodiment of the present invention relates to a method for preparing a bone cement paste from two starting components using a kit according to either the ninth or tenth embodiment of the present invention, comprising the following method steps: a. providing two starting components in a container; b. fastening the adapter to the handle using a fastening element; c. connecting the adapter to the electric drive using a connecting element; d. mixing the starting components in the container with a mixing rod by operating an electric drive device, wherein a bone cement paste is prepared by mixing.

[0026] One embodiment of the method includes a method step e., which includes removing the adapter from the handle of the mixing rod. This embodiment is a twelfth embodiment of the present invention, and is preferably dependent on the eleventh embodiment of the present invention.

[0027] An embodiment of the method includes a method step f., which includes removing the bone cement paste from the mixing system. This embodiment is a thirteenth embodiment of the present invention, and is preferably dependent on the eleventh or twelfth embodiment of the present invention. general

[0028] In this specification, range specifications also include the values ​​specified as limits. A specification of the type "in the range from X to Y" for a quantity A consequently means that A can take on values ​​X, Y and values ​​between X and Y. A range limited on one side of the type "up to Y" for a size A consequently means values ​​Y and less than Y.

[0029] Some of the described features are associated with the term "substantially." The term "substantially" should be understood as meaning that under actual conditions and manufacturing techniques, a mathematically precise interpretation of terms such as "overlap," "perpendicular," "diameter," or "parallelism" can never be given precisely, but can only be given within a certain manufacturing tolerance. For example, "substantially perpendicular axes" encompass angles of 85 to 95 degrees relative to each other, and "substantially the same volume" includes a deviation of up to 5% by volume. For example, a "device consisting essentially of plastic" includes a plastic content of 95 to 100% by weight. For example, "substantially complete filling of volume B" includes a filling of 95 to 100% by volume of the total volume of B.

[0030] The terms "proximal" and "distal" are used only to designate spatially opposite ends of a device or other structural units of a device and do not allow any conclusions regarding their orientation relative to the human body, e.g., a user of the device. "Distal to" and "proximal to" or similar expressions only describe the spatial arrangement of two structural units of a device relative to each other. [Mode for Carrying Out the Invention]

[0031] The present invention first provides an adapter for a mixing system for preparing a bone cement paste from two starting components, comprising: a fastening element for reversibly fastening the adapter to a handle of the mixing system, the handle being designed to mix two starting components in a container of the mixing system by a mixing rod of the mixing system, thereby preparing a bone cement paste; a connecting element for reversibly connecting the adapter to the electric drive; The adapter is designed to establish a force transmission connection between the electric drive and the handle, whereby the mixing rod can be mechanically operated using the electric drive.

[0032] The adapter is used to temporarily and reversibly connect a mixing system for preparing bone cement paste from two starting components to an electric drive, such as an electric drill, so that the electric drive can transmit rotational motion to the mixing rod of the mixing system via the adapter. The rotating mixing rod serves to mix the starting components in the mixing system, particularly in the mixing system's container, thereby preparing the bone cement paste.

[0033] The adapter thus gives the user of the mixing system the option of operating the mixing system both manually, i.e., using physical force to mix the bone cement paste, and with an electric drive. The adapter thus simply, inexpensively, and quickly increases the flexibility for the user of the mixing system.

[0034] The adapter is designed to be reversibly fastened to a handle of the mixing system by a fastening element, and the handle is directly or indirectly connected to the mixing rod, such that rotation of the handle results in a rotational movement of the mixing rod, which can mix the starting components in the mixing system to form a bone cement paste.

[0035] The handle of the mixing system is designed to be grasped by a user's hand, thereby facilitating the user's manipulation of the mixing rod of the mixing system and, therefore, the rotation of the mixing rod. The handle is a component that can be firmly grasped by hand to rotate the mixing rod, and preferably also to move it axially within the mixing system. Preferably, the handle is ergonomically shaped so that it can be easily and securely grasped by hand.

[0036] The adapter is provided with a connecting element for temporarily and reversibly connecting the adapter to an electric drive device, such as a drill of some kind.

[0037] The adapter therefore comprises two elements, namely a fastening element and a connecting element, for reversibly connecting the mixing system to the electric drive in such a way that the rotational movement of the electric drive is transmitted particularly directly and immediately via the adapter to the mixing rod of the mixing system.

[0038] The fastening element can have different shapes so as to be reversibly fastened to the handle of the mixing system.

[0039] One embodiment of the adapter is characterized in that the fastening element comprises a receptacle for receiving at least 20%, preferably at least 40%, and most preferably at least 60% of the surface area of ​​the handle, based on the total surface area of ​​the handle.

[0040] The receptacle is a structured and / or shaped recess suitable for receiving and at least partially surrounding the handle therein, so that the handle can be inserted into the receptacle.

[0041] Preferably, the entire handle is receivable in a receptacle of the fastening element.

[0042] The receptacle therefore surrounds at least a portion of the surface area of ​​the handle, preferably at least 20%, preferably at least 40%, and most preferably at least 60%, based on the total surface area of ​​the handle, and thus mimics the hand of a user of the mixing system, ensuring that the adapter is securely fastened to the mixing system.

[0043] One embodiment of the adapter is characterized in that the receptacle has an interior shape that is substantially complementary to the exterior shape of the handle of the mixing system to allow the handle to be substantially interlocked inside the adapter.

[0044] As a result, the adapter ensures that the mixing rod is rotated in the most direct and controllable way possible by the electric drive.

[0045] The adapter can have different shapes to securely and reversibly fasten the mixing rod within the receptacle.

[0046] One embodiment of the adapter is characterized in that the adapter comprises a reversibly removable closure cap designed to secure the handle within the receptacle by at least partially covering the receptacle.

[0047] When the closure cap is open, the handle can be inserted into the holder, and then the cap can be closed to secure the handle to the receptacle. When closed, the closure cap covers the opening of the receptacle through which the handle can be inserted into the receptacle, so that the handle can no longer be removed from the receptacle through the opening without opening the closure cap. Thus, the closure cap is a simple way of mechanically securing the handle in the receptacle.

[0048] Preferably, the receptacle and the closure cap are formed in two parts.

[0049] More preferably, the adapter is formed in two parts, the fastening element and the receptacle being integrally formed and forming a first part of the two-part adapter, and the closure cap forming a second part of the two-part adapter.

[0050] The closure cap may have a different shape so that it is reversibly fastenable to the receptacle, thereby at least partially covering the receptacle and thus fastening the handle within the receptacle.

[0051] One embodiment of the adapter is characterized in that the closure cap can be reversibly and detachably fastened to the receptacle by locking, by clamping, by means of a cotter pin and / or by means of a hook-and-loop fastener in order to at least partially cover the receptacle, in particular the opening of the receptacle. These different types of fastening options allow for an easy and particularly quick fastening of the adapter to the handle of the mixing system, which is particularly advantageous during operation.

[0052] One embodiment of the adapter is characterized in that the connecting element is arranged at the end of the adapter axially opposite the fastening element. Preferably, the connecting element and the fastening element are arranged on a common axis, in particular the longitudinal axis of the adapter. This allows the adapter to transmit forces from the electric drive to the mixing system as efficiently as possible. This also makes the adapter easier to use.

[0053] The connecting element can have different designs so as to be reversibly connectable to the electric drive.

[0054] Preferably, the adapter is designed to reversibly connect the handle of the mixing system to an electric drive, preferably comprising a chuck, preferably a three-jaw chuck, coupled to a rotating spindle. In such a system, it may be intended to transmit a rotational movement, preferably performed via the rotating spindle, to the mixing system via the chuck and the adapter.

[0055] An embodiment of the adapter is characterized in that the connecting element comprises a rod with a circular, square or preferably hexagonal cross section in radial cross section, which can be quickly, easily and securely clamped in the chuck of the electric drive, allowing a rotational movement of the rotating spindle via the chuck and the clamped adapter and ultimately to the mixing rod for mixing the bone cement paste.

[0056] One embodiment of the adapter is characterized in that the adapter is designed so that when the adapter is fastened to the handle of the mixing system, the mixing rod of the mixing system has a common axis, in particular a longitudinal axis, with the connecting element of the adapter. In this embodiment, the adapter acts as a kind of extension of the mixing rod, and the user can rotate the mixing rod using the fastening means instead of the handle of the mixing system. Furthermore, this design allows efficient and easy rotation of the mixing rod via an electric drive.

[0057] The invention further relates to a kit for preparing a bone cement paste from two starting components, the kit comprising an adapter according to any one of the previous embodiments and a mixing system.

[0058] The mixing system comprises a container in which bone cement powder can be, or preferably is, stored as a first starting component, and a mixing rod having a handle reversibly axially displaceable and rotatably mounted in the container, in particular mounted for reversible rotation about its own longitudinal axis, The handle is arranged outside the container and is designed to rotate the mixing rod inside the container, preferably to move the mixing rod axially inside the container, thus preparing the bone cement paste.

[0059] The features of the mixing system described in relation to the adapter also apply to the mixing system of the kit.

[0060] One embodiment of the kit is characterized in that the mixing system comprises a reservoir capable of, and preferably does, store a monomer liquid as the second starting component. Preferably, the monomer liquid is disposed in a monomer liquid container.

[0061] The monomer liquid container is a container for the monomer liquid that allows the monomer liquid to be stored safely, particularly under sterile conditions, until use. A variety of monomer liquid containers are known to those skilled in the art.

[0062] For example, the monomer liquid container may be a bag. A preferred bag is a multi-layer composite film having an EVOH (ethylene vinyl alcohol) barrier layer, optionally including a metal coating, particularly an aluminum coating.

[0063] Preferably, the monomer liquid container is an ampoule, preferably a glass ampoule, which is preferred because it allows for more controlled opening and it is easier for the entire monomer liquid to flow out of the ampoule which opens in a fluidly conducting manner.

[0064] Preferably, both the bone cement powder (in the container) and the at least one monomer liquid container (in the reservoir) are stored in the mixing system, which makes it easier for the user to use the kit and in particular allows the bone cement paste to be prepared under sterile conditions.

[0065] The present invention also relates to a method for preparing a bone cement paste from two starting components using a kit according to any one of the previous embodiments, comprising the following method steps: a. providing two starting components in a container; b. fastening the adapter to the handle using a fastening element; c. connecting the adapter to the electric drive using a connecting element; d. mixing the starting components in the container with the mixing rod by operating the electric drive, wherein a bone cement paste is prepared by mixing.

[0066] In method step a), the two starting components of the bone cement paste are provided in a container of the mixing system of the kit for mixing, and for this purpose, a monomer liquid is preferably transferred as the second starting component from a reservoir of the mixing system into the container of the mixing system in which the bone cement powder is already stored as the first starting component.

[0067] In method step b, the adapter is fastened to the handle of the mixing system using the fastening element.

[0068] In a preferred embodiment of method step b, to do this, the handle is inserted into a receptacle of the fastening element, preferably substantially complementary to the outer shape of the handle, and the receptacle is secured by a reversibly removable closure cap by partially covering the receptacle, preferably such that at least 60% of the surface area of ​​the handle, based on the total surface area of ​​the handle, is received in the receptacle.

[0069] In method step c, the adapter is connected to the electric drive by means of a connecting element.

[0070] In a preferred embodiment of method step c), a connecting element in the form of a rod with a hexagonal radial cross section is clamped in a chuck of the electric drive.

[0071] Method steps a, b and c can be performed in any order, however preferably the adapter is connected to at least the electric drive before the monomer liquid is delivered to the bone cement powder.

[0072] In step d of the method, the starting components are mixed in the mixing system to prepare a bone cement paste. For this purpose, the electric drive is operated appropriately, so that the rotational movement of the drive is transmitted to the handle of the mixing system via an adapter, preferably directly. By turning the handle, the mixing rod of the mixing system is rotated, preferably directly, and the starting components are mixed in the mixing system.

[0073] One embodiment of the method is characterized in that in one method step, step e, the adapter is removed from the handle of the mixing rod, which method step is preferably performed after method step d. By removing the adapter from the handle, the electric drive and the mixing system are again separated, and the user of the kit can continue to use the mixing system as if the bone cement paste had been mixed by manually manipulating the mixing rod. The adapter is therefore immediately available again, for example, for use with another mixing system, preferably of the same design.

[0074] One embodiment of the method is characterized in that in one method step, step f, the bone cement paste is removed from the mixing system. Method step f occurs after method step d. Preferably, if used, it occurs after method step e.

[0075] The kit and / or mixing system is characterized by the fact that it prepares a bone cement paste consisting of two starting components. Bone cement paste is a substance suitable in the field of medical technology for creating a stable connection between artificial joints, such as hip and knee joints, and bone material. Upon hardening, the bone cement paste transforms into bone cement. These bone cements are preferably polymethyl methacrylate bone cements (PMMA bone cements). PMMA bone cements have long been used in medical applications, dating back to the work of Sir Charnley (Charnley, J., Anchorage of the femoral head test of the drawing of the femur, J. Bone Joint Surg. 1960(42), 28-30). PMMA bone cement can be produced from a bone cement powder as the first starting component and a monomer liquid as the second starting component. With the appropriate composition, the two starting components can be shelf-stable separately from each other. Upon contacting the two starting components, swelling of the polymer component of the bone cement powder produces a plastically deformable bone cement paste. Polymerization of the monomers is initiated by radicals, and as the polymerization of the monomers progresses, the viscosity of the bone cement paste increases until it is fully hardened.

[0076] The bone cement powder is 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 can further comprise a hydrophilic additive that aids in the distribution of the monomer liquid within the bone cement powder. In a further embodiment, the bone cement powder can further comprise an initiator that initiates polymerization. In a further embodiment, the bone cement powder can further comprise a radiopaque material. In yet another embodiment, the bone cement powder can further comprise a pharmaceutically active substance, such as an antibiotic.

[0077] The bone cement powder preferably comprises or consists of at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer as a hydrophilic additive, an initiator, and a radiopaque material. More preferably, the bone cement powder comprises or consists of at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer, an initiator, a radiopaque material, and a hydrophilic additive. Most preferably, the bone cement powder comprises or consists of at least one particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer, an initiator, a radiopaque material, a hydrophilic additive, and an antibiotic.

[0078] According to the invention, the particle size of the particulate polymethyl methacrylate and / or particulate polymethyl methacrylate copolymer of the bone cement powder of the sieve fraction may correspond to less than 150 μm, preferably less than 100 μm.

[0079] According to the present invention, the hydrophilic additive may be particulate and / or fibrous. In a further embodiment, the hydrophilic additive may be slightly soluble, preferably insoluble, in methyl methacrylate. In a further embodiment, the hydrophilic additive may have a water absorption capacity of at least 0.6 g of methyl methacrylate per gram of hydrophilic additive. In a further embodiment, the hydrophilic additive may comprise a chemical substance having at least one OH group. Preferably, the hydrophilic additive may have an OH group covalently bonded to its surface. Examples of such preferred hydrophilic additives may be additives selected from the group including cellulose, oxidized cellulose, starch, titanium dioxide, and silicon dioxide, with fumed silicon dioxide being particularly preferred. In one embodiment, the particle size of the hydrophilic additive may correspond to a sieve fraction of less than 100 μm, preferably less than 50 μm, and most preferably less than 10 μm. The hydrophilic additive may be present in an amount of 0.1 to 2.5 wt. % based on the total weight of the bone cement powder.

[0080] According to the present invention, the initiator may contain or consist of dibenzoyl peroxide.

[0081] According to the present invention, radiopaque materials are understood to be substances that allow the bone cement to be visualized on diagnostic X-ray images. Examples of radiopaque materials include barium sulfate, zirconium dioxide, and calcium carbonate.

[0082] According to the present invention, the pharmaceutically active substance can comprise 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 include gentamicin, clindamycin, and vancomycin, among others.

[0083] According to the present invention, the monomer liquid can comprise or consist of the monomer methyl methacrylate. In one embodiment, the monomer liquid comprises, in addition to the monomer, an activator such as N,N-dimethyl-p-toluidine dissolved therein, or consists of methyl methacrylate and N,N-dimethyl-p-toluidine.

[0084] Features disclosed in relation to the adapter are also disclosed in relation to the kit, mixing system, and method, and vice versa. [Brief explanation of the drawings]

[0085] The invention is further explained by the following examples with the aid of the drawings, to which the invention is not limited.

[0086] [Figure 1] 1 is a perspective side view of an exemplary kit for preparing bone cement paste including an adapter and a mixing system, and a perspective side view of an electric drive unit. [Figure 2] 2 is a schematic longitudinal cross-sectional view of the components and electric drive of the kit of FIG. 1; [Figure 3] 3A and 3B are schematic longitudinal and side views of the adapter of FIGS. 1 and 2, respectively, with the closure cap open and closed; [Figure 4] 3 is a schematic longitudinal section through the kit and electric drive of the previous figure, in which the adapter is connected to the electric drive via a connecting element; FIG. [Figure 5] FIG. 2 is a schematic longitudinal section through the kit and electric drive of the previous figure, in which the adapter is connected to the electric drive via a connecting element and to the handle of the mixing system via a fastening element; [Figure 6] 10 is a perspective side view of the kit and electric drive of the previous figure, with the adapter connected to the electric drive via a connecting element and to the handle of the mixing system via a fastening element. FIG. [Figure 7] FIG. 1 is a schematic side view of another exemplary kit for preparing bone cement paste having an adapter and a mixing system; [Figure 8] 1 shows a flow chart of a method for preparing a bone cement paste. DETAILED DESCRIPTION OF THE INVENTION

[0087] 1 is a perspective side view of an exemplary kit 300 for preparing bone cement paste from two starting components and an exemplary electric driver 400. The kit 300 includes an adapter 100 and a mixing system 200 including a handle 210. The adapter 100 is designed to connect to both the handle 210 of the mixing system 200 and the chuck 410 of the electric driver 400, thereby forming a force-transmitting connection between the handle 310 and the electric driver 400, such that rotational motion of the electric driver 400 can be transmitted to the handle 210 via the adapter 100, allowing bone cement paste to be prepared in a container 220 of the mixing system 200. This functionality will be described in more detail in connection with the following figures.

[0088] FIG. 2 is a schematic longitudinal cross-sectional view of a portion of the kit 300 and the electric drive 400 of FIG. 1 . The adapter 100 includes a fastening element 110 in the form of a receptacle for receiving the handle 210 of the mixing system 200. The receptacle 110 is shaped to fully receive the handle 210 and has an inner shape that is substantially complementary to the outer shape of the handle. Thus, the illustrated embodiment allows for a substantially interlocking connection of the handle 210 to the inside of the adapter 100, and in particular to the inside of the fastening element 110 of the adapter 100. To secure the handle 210 to the fastening element 110 after the handle 210 has been inserted, the adapter 100 includes a reversibly removable closure cap 116 that is open in FIG. 2 . When the closure cap 116 is open, the handle 210 can be inserted into and removed from the fastening element 110. Regarding the function of the closure cap 116, reference is made to the following figures, in particular to FIG. 3 .

[0089] At its axially opposite end to the fastening element 110, the adapter 100 is provided with a connecting element 120 in the form of a rod, in particular a hexagonal rod (see FIG. 3 ), which can be inserted into a chuck 410 of the electric drive 400 and fixed therein.

[0090] 2 shows that the handle 210 is connected to a mixing rod 230 that projects into the interior 225 of the container 220 of the mixing system 200 and is rotatably and axially displaceably mounted therein. At the end axially opposite the handle 210, the mixing rod 230 is provided with a mixing element 235 in the form of a radially projecting blade that facilitates mixing of the starting components of the bone cement paste.

[0091] Bone cement powder 500 is stored within interior 225 as the first starting component of the bone cement paste.

[0092] FIG. 3 shows the adapter 100 of FIGS. 1 and 2 in both a schematic longitudinal cross-sectional view (3A and 3B) and a perspective side view (3A' and 3B').

[0093] 3A and 3A', the closure cap 116 is open, as already shown in Figure 2. Upon opening, the closure cap 116 is displaced radially outward from the longitudinal axis 105 of the adapter 100, which extends through the connecting element 120. As a result, the opening 115 of the fastening element 110 is released, so that the handle 410 of the mixing system 200 (see, e.g., Figure 2) can be inserted into the adapter 100 and secured within the fastening element 110.

[0094] 3B and 3B', however, the closure cap 116 is closed. The closure cap 116 can be reversibly switched from an open state to a closed state by moving it in the direction of the longitudinal axis 105. When closed, the closure cap 116 can fix the handle 210 of the mixing system 200 in the fastening element 110, so that a rotational movement applied to the connecting element 120 can be transmitted to the handle 210 via the fastening element 110. For this purpose, the closure cap 116 covers a part of the opening 115 of the fastening element 110, thereby preventing the handle 210, which is placed in the fastening element 110, from being removed therefrom. To reliably fix the closure cap 116 in the closed state, the closure cap is reversibly fastened to the fastening element 110 by a lock.

[0095] 4 is a schematic longitudinal section through the kit 300 and electric drive of FIGS. 1 and 2, in which the connecting element 120 is inserted into a chuck 410 of the electric drive 400 and fixed therein. The closure cap 116 is in an open state so that the handle 410 can be inserted into the fastening element 110, as also already shown in FIG.

[0096] FIG. 5 is a schematic longitudinal cross-sectional view of the kit 300 and electric drive of FIGS. 1, 2, and 4, with the addition that the handle 210 of the mixing system 200 is fixed to the fastening means 110. For this purpose, the closure cap 116 is moved in the direction of the longitudinal axis 105 of the adapter 100 (see FIG. 3), so that the closure cap is locked to the fastening means 110 in a closed state and thus fastened. Thus, the adapter 100 of FIG. 5 enables a force-transmitting connection between the electric drive 400, particularly the chuck 410, and the handle 210 of the mixing system 200. Thus, the rotational movement caused by appropriate actuation of the electric drive 400 is directly transmitted to the mixing rod 230, thereby allowing the bone cement paste to be mixed during its preparation. In FIG. 5, only the provision of a monomer liquid as a second starting component in the interior 225 of the container 220 is omitted.

[0097] Figure 6 is a perspective side view of the kit 300 and electric driver of Figures 1, 2, 4, and 5, with the adapter 100 connected to both the electric driver 400 and the handle 210, thus establishing a force transmission connection between the two, as described with respect to Figure 5. By properly operating the electric driver 400, the starting components of the bone cement paste can be mixed within the mixing system 200, particularly within the interior 225 of the container 220 (see, e.g., Figure 2), thereby preparing the bone cement paste.

[0098] 7 is a schematic side view of another exemplary kit 300′ for preparing a bone cement paste from two starting components. The kit 300′ comprises the adapter 100 as already described in the previous figures and another exemplary mixing system 200′. The mixing system 200′ differs from the mixing system 200 of the previous figures by an additional reservoir 240 in which a glass ampoule (not shown) filled with a monomer liquid as the second starting component is stored. Furthermore, bone cement powder is stored in a container 210′ ​​of the mixing system 200′ as the first starting component (not shown). For the exact structure and function of the mixing system 200′, reference is made to the disclosure of EP 3093067 A1.

[0099] With respect to the use of the adapter 100 with the mixing system 200', and particularly with its handle 210', reference is made to the previous figure, as the mixing system 200' does not differ significantly in essential respects from the mixing system 200 of the previous figure. Thus, the adapter 100 can be used with the mixing system 200' in a manner substantially similar to that of the above-described figures.

[0100] FIG. 8 shows an exemplary method 600 for preparing a bone cement paste from two starting components using the kit 300, 300′ of the previous figure, including method steps 610-640, and optionally method step 650 and / or method step 660, although the order of method steps 610-630 may differ from that shown.

[0101] In method step 610, two starting components are provided in the container 210, 210′ ​​of the mixing system 200, 200′, in particular in the interior 225 of the container 210, 210′. Preferably, the bone cement powder 500 is already stored in the container 210, 210′ ​​as the first starting component of the bone cement paste before the monomer liquid is transferred into the container 210, 210′ ​​as the second starting component. The monomer liquid is preferably stored in the reservoir 240 of the mixing system 200′ before being transferred into the container 210, 210′.

[0102] In method step 620, the adapter 100 is fastened to the handle 210, 210′ ​​of the mixing system 200, 200′ by the fastening element 110. For this purpose, the handle 210, 210′ ​​is preferably inserted into a receptacle of the fastening element 110 and secured there by a closure cap 116.

[0103] In method step 630, the adapter 100 is connected to an electric drive 400, preferably to a chuck 410 of the electric drive, preferably by means of a connecting element 120 in the form of a rod, preferably a hexagonal rod.

[0104] Method steps 620 and 630 establish a force transmission connection between the electric drive 400 and the handle 210, 210' so that the mixing rod 230, 230' can be mechanically manipulated using the electric drive.

[0105] In method step 640, the starting components of the bone cement paste prepared in the containers in method step 610 are mixed. For this purpose, the electric drive 400 is suitably activated, for example by pressing a power button on the electric drive 400, whereby a rotational movement of the electric drive 400 is transmitted via the adapter 100 and the handles 210, 210′ ​​to the mixing rods 230, 230′ of the mixing systems 200, 200′. The mixing rods 230, 230′, thus driven by the electric drive 400, mix the starting components provided for preparing the bone cement paste.

[0106] In optional method step 650, the adapter 100 may again be detached from the handle 210, 210' of the mixing system 200, 200', allowing continued manual manipulation of the handle 210, 210' and / or continued use of the adapter 100 with another mixing system 200, 200'.

[0107] In optional method step 660, the bone cement paste prepared during method 600 is removed from mixing system 200, 200'. To this end, method step 650 is preferably performed first. [Explanation of symbols]

[0108] 100 adapter 110 Fastening Elements 115 Opening 116 Closure Cap 120 connecting elements 200, 200' Mixed System 210, 210' handle 220, 220' container 225 Internal 230, 230' Mixed Rod 235 Mixed elements 240 reservoir 300, 300' Kit 400 Electric Drive 410 Chuck 500 Bone Cement Powder 600 ways 610 offers 620 Conclusion 630 connections 640 mixed 650 Removal 660 Delete

Claims

1. An adapter (100) for a mixing system (200, 200') for preparing a bone cement paste from two starting components, comprising: a fastening element (110) for reversibly fastening the adapter (100) to a handle (210, 210') of the mixing system (200, 200'), the handle (210, 210') being designed to mix the two starting components in the containers (220, 220') of the mixing system (200, 200') by means of a mixing rod (230, 230') of the mixing system (200, 200'), thereby preparing the bone cement paste; a connecting element (120) for reversibly connecting the adapter (100) to an electric drive (400); The adapter (100) is designed to establish a force transmission connection between the electric drive unit (400) and the handle (210, 210'), whereby the mixing rod (230, 230') can be mechanically operated using the electric drive unit (400), adapter (100).

2. 2. The adapter (100) of claim 1, wherein the fastening element (110) comprises a receptacle for receiving at least 20%, preferably at least 40%, and most preferably at least 60% of the surface area of ​​the handle (210, 210'), based on the total surface area of ​​the handle (210, 210').

3. 3. The adapter (100) of claim 2, wherein the receptacle has an interior shape that is substantially complementary to an exterior shape of the handle (210, 210') to enable the handle (210, 210') to be substantially interlocked with the interior of the adapter (100).

4. 3. The adapter (100) of claim 2, comprising a reversibly removable closure cap (116) designed to secure the handle (210, 210') within the receptacle by at least partially covering the receptacle.

5. 5. The adapter (100) of claim 4, wherein the closure cap (116) can be reversibly and removably fastened to the receptacle by locking, clamping, cotter pins, and / or hook-and-loop fasteners to at least partially cover the receptacle.

6. The adapter (100) of claim 1, wherein the connecting element (120) is disposed at an end of the adapter (100) axially opposite the fastening element (110).

7. 2. The adapter (100) of claim 1, wherein the connecting element (120) comprises a rod having, in radial cross section, a circular, square, or preferably a hexagonal cross section.

8. The adapter (100) of claim 1, wherein the adapter (100) is designed so that when the adapter (100) is fastened to the handle (210, 210') of the mixing system (200, 200'), the mixing rod (210, 210') of the mixing system (200, 200') has a common longitudinal axis with the connecting element (120) of the adapter (100).

9. A kit (300, 300') for preparing a bone cement paste from two starting components, comprising: an adapter (100) according to claim 1; and a mixing system (200, 200'), the mixing system (200, 200') comprising a container (220, 220') in which a bone cement powder (500) is or can be stored as a first starting component; a mixing rod (230, 230') axially displaceably and rotatably mounted within the container (220, 220') and having a handle (210, 210') accessible from outside the container (220, 220'), for rotating the mixing rod (230, 230') inside the container (220, 220'), thereby preparing the bone cement paste.

10. 10. The kit (300') of claim 9, wherein the mixing system (200') comprises a reservoir (240) in which a monomer liquid is or can be stored as a second starting component.

11. 10. A method (600) for preparing a bone cement paste consisting of two starting components by means of a kit (300, 300') according to claim 9, comprising the following method steps: a. Providing (610) the two starting components in the vessels (220, 220'); b. fastening (620) the adapter (100) to the handle (210, 210') using the fastening element (110); c. Connecting (630) the adapter (100) to an electric drive (400) using the connecting element (120); and d) mixing (640) the starting components in the container (220, 220') with the mixing rod (230, 230') by operating the electric driver (400), wherein the bone cement paste is prepared by mixing (640).

12. 12. The method (600) of claim 11, further comprising method step e., wherein method step e. comprises removing (650) the adapter (100) from the handle (210, 210') of the mixing rod (230, 230').

13. 12. The method (600) of claim 11, further comprising a method step f., wherein the method step f. comprises removing the bone cement paste (660) from the mixing system (200, 200').

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