DE102018218302A1 - Device for providing bone cement - Google Patents

Abstract

The invention relates to a device for providing a bone cement from two starting components, comprising a hollow cylindrical first container in which a monomer liquid can be stored as the first starting component, a hollow cylindrical second container having a container wall, a first interior and a second interior, in the first interior a bone cement powder can be stored as a second starting component, and wherein the monomer liquid can be conveyed into the second interior, a fluid-conducting conveying means arranged between the first interior and the second interior, the first container and the second container being axially connected to one another. The invention further relates to a method for providing a bone cement from two starting materials by means of a device comprising a hollow cylindrical first container in which a monomer liquid is stored as a first starting component in a vessel, a hollow cylindrical second container having a container wall, a first interior and a second interior, wherein a bone cement powder is stored in the first interior as the second starting component, the monomer liquid being able to be conveyed into the second interior, a fluid-conducting conveying means arranged between the first interior and the second interior, and wherein the first container and the second container are axially connected to one another.

Description

The invention relates to a device for providing a bone cement from two starting components, comprising a hollow cylindrical first container in which a monomer liquid can be stored as the first starting component, a hollow cylindrical second container having a container wall, a first interior and a second interior, in the first interior a bone cement powder can be stored as the second starting component, and wherein the monomer liquid can be conveyed into the second interior, a fluid-conducting conveying means arranged between the first interior and the second interior, the first container and the second container being axially connected to one another. The invention further relates to a method for providing a bone cement from two starting materials by means of a device comprising a hollow cylindrical first container in which a monomer liquid is stored as a first starting component in a vessel, a hollow cylindrical second container having a container wall, a first interior and a second interior, wherein a bone cement powder is stored in the first interior as a second starting component, the monomer liquid being able to be conveyed into the second interior, a fluid-conducting conveying means arranged between the first interior and the second interior, and wherein the first container and the second container are axially connected to one another.

Background of the Invention

Significant efforts are being made to demonstrate devices and methods for providing bone cement by means of which bone cement can be provided simply, safely and quickly. An important aspect in the provision of bone cement is the avoidance of air pockets in the bone cement. To avoid this, a variety of vacuum cementing systems have been described, of which the following are mentioned as examples: US 6,033,105 A , US 5,624,184 A , US 4,671,263 A , US 4,973,168 A , US 5,100,241 A , WO 99/67015 A1 , EP 1020167 A2 , US 5,586,821 A , EP 1016452 A2 , DE 3640279 A1 , WO 94/26403 A1 , EP 1005901 A2 , EP 1886647 A1 , US 5,344,232 A .

There is a desire in the market to simplify the provision of bone cement. A further development consists in the development of cementing systems in which both starting components are stored in separate areas of the mixing systems and are only mixed with one another immediately before the cementing application in the cementing system. Such closed, so-called full-prepacked systems are mentioned in the following documents: EP 0692229 A1 , DE 10 2009 031 178 B3 , US 5,997,544 A , US 6,709,149 B1 , DE 698 12 726 T2 , EP 0796653 A2 , US 5,588,745 A .

In the DE 10 2016 121 607 A1 describes a full prepack system, the container filled with monomer liquid being stored axially behind the bone cement. It is disadvantageous that the container filled with monomer liquid must be completely destroyed in the course of mixing the starting components. It has also been found to be disadvantageous that the force input for mixing the starting components and later also for discharging the mixed bone cement always also acts on the remains of the destroyed container. This leads to increased effort on the part of the user and to jerky and uncontrollable movements both in the course of the destruction of the containers and in the course of the mixing and later discharge of the mixed cement. Both significantly complicate the applicability of the full prepack system, particularly in the context of time-critical operating conditions. It has also turned out to be equally disadvantageous that the destroyed container makes the use of the full prepack system more difficult. This occurs, for example, through fragments of the container that retain the monomer liquid, which is then not available for the production of the bone cement. Another disadvantage arises from wedging of the remains of the container within the mixing and discharge device. Another disadvantage is the risk potential of the fragments for both the user and the patient.

tasks

An object of the present invention is to at least partially overcome one or more of the disadvantages arising from the prior art.

In particular, the invention is based on the aim of providing devices for providing a bone cement from two starting components with a lower force required by the user than previous cementing systems, which are also easy to use and safe to use. The goal is also to minimize the risk of infection for the patient. The devices should be suitable for being able to store the two starting components separately from one another. The two starting components should be able to be brought together in the device within a few seconds in the closed device. The device is intended to provide the bone cement without mechanical mixing of the starting components. The device should also be designed so that the Users do not have to carry out any assembly steps. The device should be able to provide the bone cement without an external vacuum. The device should be able to discharge the bone cement provided. The device should be able to dispense the bone cement provided without conversion measures. The device should be able to provide and dispense the bone cement without conversion measures and without external equipment such as hoses, vacuum sources or extrusion devices. The device should be able to be operated with as few work steps as possible in order to minimize sources of error by the user.

It is a further object of the invention to provide a method with which bone cement can be provided from two starting components, by means of which at least some of the tasks already described are at least partially achieved.

Preferred embodiments of the invention

• |1| Vorrichtung zum Bereitstellen eines Knochenzements aus zwei Ausgangskomponenten, umfassend
  • ein hohlzylinderförmiges erstes Behältnis, in dem eine Monomerflüssigkeit als erste Ausgangskomponente lagerbar ist,
  • ein hohlzylinderförmiges zweites Behältnis aufweisend eine Behältniswand, einen ersten Innenraum und einen zweiten Innenraum,
  • wobei in dem ersten Innenraum ein Knochenzementpulver als zweite Ausgangskomponente lagerbar ist, und
  • wobei die Monomerflüssigkeit in den zweiten Innenraum förderbar ist,
  • ein fluidleitendes Fördermittel, angeordnet zwischen dem ersten Innenraum und dem zweiten Innenraum,
  • wobei das erste Behältnis und das zweite Behältnis axial miteinander verbunden sind,
  • gekennzeichnet durch
  • einen axial im zweiten Behältnis verschiebbaren Austragskolben, angeordnet zwischen erstem Behältnis und zweitem Innenraum,
  • wobei der Austragskolben derart mit der Behältniswand zusammenwirkt, dass
  • in einer ersten Position des Austragskolbens das erste Behältnis und der zweite Innenraum fluidleitend für die Monomerflüssigkeit verbunden sind, und
  • in einer zweiten Position des Austragskolbens das erste Behältnis und der zweite Innenraum nicht fluidleitend für die Monomerflüssigkeit verbunden sind.
• |2| Vorrichtung nach Ausführungsform 1, dadurch gekennzeichnet, dass die Behältniswand ein erstes Teilstück mit mindestens einer Vertiefung und ein zweites Teilstück, welches vertiefungsfrei ausgebildet ist, aufweist.
• |3| Vorrichtung nach Ausführungsform 2, dadurch gekennzeichnet, dass der Austragskolben in der ersten Position derart an das erste Teilstück angrenzt, dass der Austragskolben von der Monomerflüssigkeit über die mindestens eine Vertiefung umströmbar ist.
• |4| Vorrichtung nach Ausführungsform 2 oder 3, dadurch gekennzeichnet, dass der Austragskolben in der zweiten Position derart an das zweite Teilstück angrenzt, dass der Austragskolben von der Monomerflüssigkeit nicht umströmbar ist.
• |5| Vorrichtung nach einer der vorhergehenden Ausführungsformen, dadurch gekennzeichnet, dass der Austragskolben bombiert ist.
• |6| Vorrichtung nach einer der vorhergehenden Ausführungsformen, dadurch gekennzeichnet, dass das erste Behältnis und der Austragskolben einstückig ausgestaltet sind.
• |7| Vorrichtung nach einer der vorhergehenden Ausführungsformen, dadurch gekennzeichnet, dass das erste Behältnis ein Gefäß mit der Monomerflüssigkeit beinhaltet.
• |8| Vorrichtung nach Ausführungsform 7, dadurch gekennzeichnet, dass das erste Behältnis eine Öffnungsvorrichtung für das Gefäß aufweist.
• |9| Vorrichtung nach Ausführungsform 7 oder 8, dadurch gekennzeichnet, dass das Gefäß eine Glasampulle ist.
• |10| Vorrichtung nach Ausführungsform 9, dadurch gekennzeichnet, dass die Öffnungsvorrichtung ein Anstechdorn ist.
• |11| Vorrichtung nach einer der Ausführungsformen 8 bis 10, dadurch gekennzeichnet, dass das erste Behältnis einen axial verschiebbaren Förderkolben umfasst, ausgestaltet derart, dass das Gefäß durch den Förderkolben auf die Öffnungsvorrichtung förderbar ist.
• |12| Vorrichtung nach einer der vorhergehenden Ausführungsformen, dadurch gekennzeichnet, dass das erste Behältnis zumindest teilweise axial in das zweite Behältnis einschiebbar ist, derart, dass der Austragskolben über die Länge des zweiten Innenraums und mindestens einen Teil der Länge des ersten Innenraums bewegbar ist.
• |13| Vorrichtung nach einem der vorhergehenden Ausführungsformen, dadurch gekennzeichnet, dass das erste Behältnis ein Außengewinde und das zweite Behältnis ein Innengewinde aufweist, wobei das Außengewinde und das Innengewinde form- und/oder kraftschlüssig miteinander verbunden oder verbindbar sind.
• |14| Verfahren zum Bereitstellen eines Knochenzementes aus zwei Ausgangskomponenten mittels einer Vorrichtung umfassend ein hohlzylinderförmiges erstes Behältnis, in dem eine Monomerflüssigkeit als erste Ausgangskomponente in einem Gefäß lagert,
  • ein hohlzylinderförmiges zweites Behältnis aufweisend eine Behältniswand, einen ersten Innenraum und einen zweiten Innenraum,
  • wobei in dem ersten Innenraum ein Knochenzementpulver als zweite Ausgangskomponente lagert,
  • wobei die Monomerflüssigkeit in den zweiten Innenraum förderbar ist,
  • ein fluidleitendes Fördermittel, angeordnet zwischen dem ersten Innenraum und dem zweiten Innenraum, und wobei das erste Behältnis und das zweite Behältnis axial miteinander verbunden sind, zumindest umfassend die folgenden sequenziellen Teilschritte:
    1. a. Öffnen des Gefäßes,
    2. b. Fließen der Monomerflüssigkeit um den Austragskolben herum in den zweiten Innenraum,
    3. c. Fördern der Monomerflüssigkeit aus dem zweiten Innenraum in den ersten Innenraum durch eine erste Verschiebung des ersten Behältnisses in das zweite Behältnis,
    4. d. Ausbildung des Knochenzements aus Knochenzementpulver und Monomerflüssigkeit.
• |15| Verfahren nach Ausführungsform 14, dadurch gekennzeichnet, dass der Knochenzement in einem Teilschritt e) durch eine zweite Verschiebung des ersten Behältnisses in das zweite Behältnis aus der Vorrichtung ausgetragen wird.

A contribution to the at least partial fulfillment of at least one of the aforementioned tasks is made by the features of the independent claims. The dependent claims provide preferred embodiments that help at least partially accomplish at least one of the tasks.

• | 1 | Device for providing a bone cement from two starting components, comprising
  • a hollow cylindrical first container in which a monomer liquid can be stored as the first starting component,
  • a hollow cylindrical second container having a container wall, a first interior and a second interior,
  • wherein a bone cement powder can be stored as a second starting component in the first interior, and
  • wherein the monomer liquid can be conveyed into the second interior,
  • a fluid-conducting conveying means, arranged between the first interior and the second interior,
  • the first container and the second container being axially connected to one another,
  • marked by
  • a discharge piston which can be displaced axially in the second container, arranged between the first container and the second interior,
  • the discharge piston cooperating with the container wall in such a way that
  • in a first position of the discharge piston, the first container and the second interior are fluidly connected for the monomer liquid, and
  • in a second position of the discharge piston, the first container and the second interior are not connected in a fluid-conducting manner for the monomer liquid.
• | 2 | Device according to embodiment 1, characterized in that the container wall has a first section with at least one recess and a second section, which is designed without a recess.
• | 3 | Device according to embodiment 2, characterized in that the discharge piston adjoins the first section in the first position in such a way that the discharge piston can flow around the monomer liquid via the at least one recess.
• | 4 | Device according to embodiment 2 or 3, characterized in that the discharge piston in the second position adjoins the second section such that the discharge liquid cannot flow around the monomer liquid.
• | 5 | Device according to one of the preceding embodiments, characterized in that the discharge piston is cambered.
• | 6 | Device according to one of the preceding embodiments, characterized in that the first container and the discharge piston are designed in one piece.
• | 7 | Device according to one of the preceding embodiments, characterized in that the first container contains a vessel with the monomer liquid.
• | 8 | Device according to embodiment 7, characterized in that the first container has an opening device for the vessel.
• | 9 | Device according to embodiment 7 or 8, characterized in that the vessel is a glass ampoule.
• | 10 | Device according to embodiment 9, characterized in that the opening device is a piercing spike.
• | 11 | Device according to one of the embodiments 8 to 10, characterized in that the first container comprises an axially displaceable delivery piston, designed in such a way that the vessel can be delivered to the opening device by the delivery piston.
• | 12 | Device according to one of the preceding embodiments, characterized in that the first container is at least partially axially insertable into the second container, such that the discharge piston is movable over the length of the second interior and at least part of the length of the first interior.
• | 13 | Device according to one of the preceding embodiments, characterized in that the first container has an external thread and the second container has an internal thread, the external thread and the internal thread being positively and / or non-positively connected or connectable to one another.
• | 14 | Method for providing a bone cement from two starting components by means of a device comprising a hollow cylindrical first container in which a monomer liquid is stored as a first starting component in a vessel,
  • a hollow cylindrical second container having a container wall, a first interior and a second interior,
  • wherein a bone cement powder is stored in the first interior as the second starting component,
  • wherein the monomer liquid can be conveyed into the second interior,
  • a fluid-conducting conveying means, arranged between the first interior and the second interior, and wherein the first container and the second container are axially connected to one another, at least comprising the following sequential substeps:
    1. a. Opening the vessel,
    2. b. Flow of the monomer liquid around the discharge piston into the second interior,
    3. c. Conveying the monomer liquid from the second interior into the first interior by a first displacement of the first container into the second container,
    4. d. Formation of bone cement from bone cement powder and monomer liquid.
• | 15 | Method according to embodiment 14, characterized in that the bone cement is discharged from the device in a sub-step e) by a second displacement of the first container into the second container.

General

In the present description, range information also includes the values mentioned as limits. An indication of the type “in the range from X to Y” in relation to a size A therefore means that A can assume the values X, Y and values between X and Y. Unilaterally limited areas of the type "up to Y" for a size A mean accordingly as values Y and less than Y.

Detailed description of the invention

A first object of the invention relates to a device for providing a bone cement from two starting components, comprising a hollow cylindrical first container in which a monomer liquid can be stored as the first starting component, a hollow cylindrical second container comprising a container wall, a first interior and a second interior, wherein in a bone cement powder can be stored as the second starting component in the first interior, and wherein the monomer liquid can be conveyed into the second interior, a fluid-conducting conveying means arranged between the first interior and the second interior, the first container and the second container being axially connected to one another by means of an axially displaceable discharge piston arranged between the first container and the second interior, the discharge piston cooperating with the container wall in such a way that in a first position d discharge piston, the first container and the second interior are fluidly connected for the monomer liquid, and in a second position of the discharge piston, the first container and second interior are not fluidly connected for the monomer liquid. The arrangement of the discharge piston between the first container and the second interior space allows a direct, non-acting force on the monomer liquid conveyed into the second interior space by an axial displacement of the discharge piston. As a result, the vessel does not have to be completely destroyed after the vessel has been opened and the monomer liquid has flowed out. The result is less effort for the user and at the same time a controlled delivery of the monomer liquid into the first interior, since there are no fragments of the vessel in the displacement path of the discharge piston. Since the vessel only has to be opened selectively but not completely destroyed, there is also a lower risk of wedging due to fragments of the vessel during use of the device. The risk of injury from fragments is reduced for both the patient and the user.

The spatial position of the discharge piston between the first container and the second interior means that the discharge piston, in interaction with the container wall, must first be designed to be permeable to gases and liquids, so that the monomer liquid can get into the second interior. As a result, the discharge piston must be designed to be impermeable to liquids and solids, since otherwise the monomer liquid cannot be conveyed from the second interior to the first interior. According to the invention, the discharge piston undergoes a transformation from permeable to gases and liquids to impermeable to liquids and solids in the course of using the device. According to the invention, a position of the discharge piston means a state of the discharge piston or a spatial arrangement of the discharge piston in the second container.

In one embodiment, the discharge piston has at least one opening in the first position, which allows the exchange of gases and liquids between the first container and the second interior. The at least one opening in the second position of the discharge piston for liquid and solid matter is accordingly closed. For example, the discharge plunger in the first position can have at least one opening, which can be closed by rotating the discharge plunger about the longitudinal axis of the discharge plunger into the second position, so that no more exchange takes place.

The device according to the invention has hollow cylindrical containers. A hollow cylindrical container is to be understood as a tubular container which comprises an interior space and a container wall surrounding the interior space. The hollow cylindrical container has a cross section perpendicular to a longitudinal axis. According to the invention, it can be provided that a container comprises more than one interior. For example, a container can comprise two interior spaces, three interior spaces or four interior spaces. If a container comprises more than one interior space, then according to the invention these interior spaces are preferably separated from one another by a partition wall or a conveying means. According to the invention, the cross section of the containers can take any shape. For example, the cross section can be oval, square, pentagonal, hexagonal, irregular or circular.

It is preferred that the hollow cylindrical container has a cylindrical geometry with a rotationally symmetrical axis with a round cross section. This geometry allows easy handling for the user and reduces the risk of wedging of moving parts within the device due to the absence of edges. According to the invention, the containers can consist of a wide variety of materials or combinations of materials. For example, the device can be made of plastic. The plastic is preferably a transparent plastic, since in this way the user can visually check that the device is functioning properly while the device is in use.

The device according to the invention is characterized in that the first hollow cylindrical container and the second hollow cylindrical container are axially connected to one another. A connection is axial if the two longitudinal axes of the hollow cylindrical containers run essentially in the same direction and preferably essentially overlap. According to the invention, in the case of an axial connection, the cross-sectional planes of the connected containers are essentially parallel to one another.

The term "essentially" is to be understood in such a way that under real conditions and manufacturing techniques, a mathematically exact interpretation of terms such as "overlay", "vertical" or "parallelism" can never be exact, but only within certain manufacturing error tolerances. For example, the two longitudinal axes of the containers can be spaced apart by up to 5 mm, in particular by up to 2 mm, or have an outside angle of up to 5 °, in particular up to 2 °.

A further embodiment of the device according to the invention is characterized in that the container wall has a first section with at least one depression and a second section, which is designed without a depression. According to the invention, a section of the container wall is to be understood as an area of the container wall that extends in the axial direction, the area encompassing the full radial circumference of the container wall. A depression means a weakening of the thickness of the container wall, the weakening being designed on an inside of the container wall. The depressions can have any cross-sectional shapes such as round, oval, triangular, square or irregular. The depressions extend essentially axially in the container wall. The extension can run parallel to the longitudinal axis of the container or at an angle of less than 90 °. The depressions can have different widths perpendicular to the axial extent. In one embodiment, the width of the depression extends over the entire circumference of the container. In another embodiment, the depressions have a width between 0.2 mm and 3 cm, in particular between 0.5 mm and 1.5 mm. The depressions can have different depths. For example, the depressions have a depth of 0.01 mm to 2 mm, in particular of 0.1 mm to 1 mm. The depth and width of the depressions is chosen in such a way that the structural integrity of the Container is not adversely affected. For example, the depressions can have a depth of 0.5 mm and a width of 1.5 cm. The first section can have one or more than one depression. For example, the first section can have four depressions which are evenly distributed on the wall of the container with a center point angle of 90 ° between two depressions.

A further embodiment of the device according to the invention is characterized in that the discharge piston adjoins the first section in the first position such that the discharge liquid can flow around the discharge piston via the at least one recess. According to the invention, the discharge piston is in the first position at the spatial height of the first section. The depressions have a longer axial extension than an outer surface of the discharge piston adjoining the first section, so that the monomer liquid can flow from the first container around the outer surface of the discharge piston into the second interior. An advantage of this embodiment is that gravity can be used to convey the monomer liquid from the first container into the second interior, which makes additional equipment, such as pumps, superfluous. For this purpose, after the vessel has been opened, the device is held in such a way that the first container is arranged spatially higher than the second container. In addition, the structure of the device according to the invention minimizes possible sources of error and application errors, since in order to convey the monomer liquid into the second interior, only the vessel has to be opened and the device has to be held according to the orientation described above. An additional conversion or additional work step, such as flipping a lever, is not necessary.

A further embodiment of the device according to the invention is characterized in that the discharge piston in the second position is adjacent to the second section such that the monomer liquid cannot flow around the discharge piston. According to the invention, the discharge plunger lies in the second position at the spatial height of the second section, such that the discharge plunger and the container wall do not permit the exchange of liquid and solid matter between the first container and the second interior. The outer surface of the discharge plunger can connect directly to the container wall of the second section, or the outer surface of the discharge plunger can have one or more sealing rings that adjoin the container wall. The outer surface preferably has one or more sealing rings. The sealing rings preferably span the entire outer surface of the discharge piston and are mounted perpendicular to the longitudinal axis of the device. The sealing rings consist of a flexible plastic, designed in such a way that the sealing rings on the one hand ensure a good seal of the discharge plunger in the second position between the first container and the second interior, and on the other hand do not make the axial displacement of the discharge plunger too difficult for the user. A compromise between these two properties has been found with the use of two sealing rings. The embodiment of the device according to the invention reduces sources of error, since the axial displacement of the discharge piston to convey the monomer liquid from the second interior to the first interior automatically closes the second interior in a non-fluid-conducting manner to the first container. An additional conversion or additional work step, such as flipping a lever, is not necessary.

Another embodiment of the device according to the invention is characterized in that the discharge piston is cambered. According to the invention, the discharge piston can take various forms on an upper side facing the first vessel. For example, the top can be flat or cambered. According to the invention, a domed discharge piston is understood to mean a curved discharge piston, the curvature being most pronounced in the region of the axis of rotation of the discharge piston and decreasing towards the outside. The upper side is preferably cambered, so that the monomer liquid, after flowing out of the open vessel, is directed in the direction of the depressions in the container wall of the second container. A cambered discharge piston thus reduces the risk of incomplete delivery of the monomer liquid into the second interior.

A further embodiment of the device according to the invention is characterized in that the first container and the discharge piston are designed in one piece. According to the invention, the term “in one piece” is understood to mean that the first container and the discharge piston are firmly connected to one another or that the first container and the discharge piston consist of only one part. In one embodiment, the discharge piston is fixedly connected to the first housing, for example with a screw, a nail, a clamp, a wedge or a rivet. In a further embodiment, the first container is shaped in such a way that a base of the first container forms the discharge piston. If the first container and the discharge piston are formed in one piece, an input of force on the first container can be used directly to convey the monomer liquid from the second interior into the first interior. One advantage is that there are no additional components are necessary to bring about an axial movement of the discharge piston, which makes the device simpler and safer to use. Another advantage is that the force applied to move the discharge piston is axially applied to the device, which reduces the effort required by the user.

A further embodiment of the device according to the invention is characterized in that the first container contains a vessel with the monomer liquid. According to the invention, a vessel includes the monomer liquid all storage options which can store the monomer liquid hermetically sealed and sterile and which can be destroyed by manual force. Examples of vessels containing the monomer liquid are glass ampoules, plastic ampoules and plastic bags. Glass ampoules are preferred due to the ease of sterilization and easy opening by manual force.

A further embodiment of the device according to the invention is characterized in that the first container has an opening device for the vessel. According to the invention, an opening device is to be understood as a device which is suitable for destroying and thus opening the structural integrity of the vessel. According to the invention, the design of the opening device is to be selected as a function of the structural stability of the vessel. According to the invention, the material of the opening device is capable of destroying the structural integrity of the material of the vessel. It is advantageous if the opening device has a small diameter in comparison to the surface of the vessel to be opened. This reduces the force required to open the vessel. For example, the vessel can be opened by piercing or cutting. Examples of opening devices include piercing mandrels, needles, cannulas and cutting edges. In a preferred embodiment, the vessel is a glass ampoule and the opening device is a piercing spike. The antechorn has the advantage that it can open the glass ampoule selectively, but leaves the rest of the ampoule intact. In a further preferred embodiment, the vessel is a glass ampoule and the opening device is a piercing mandrel, arranged such that the piercing mandrel opens an ampoule bottom of the glass ampoule. A typical glass ampoule has an ampoule body, an ampoule head and an ampoule base. The ampoule head is characterized by a small diameter compared to the ampoule body, which acts as a predetermined breaking point. The glass ampoule is typically opened at the predetermined breaking point. The ampoule base typically has the same diameter as the ampoule body. According to the invention, it is advantageous if the glass ampoule is broken open at the bottom of the ampoule. By piercing the ampoule base by means of a piercing mandrel, the opening of the glass ampoule is controlled by a large area difference between the opening device and the ampoule base. On the other hand, the ampoule head does not break off from the rest of the ampoule body when it is opened, which reduces both the effort required to open it and the number of fragments.

A further embodiment of the device according to the invention is characterized in that the first container comprises an axially displaceable delivery piston, configured in such a way that the vessel can be delivered to the opening device by the delivery piston. According to the invention, a delivery piston is to be understood as an axially movable component which can press the vessel onto the opening device and thereby open it by means of a targeted axial displacement within the first container. According to the invention, the vessel is mounted between the opening device and the delivery piston. The delivery piston can take different forms on the side facing the vessel. For example, the delivery plunger can be flat or shaped as a shoulder element. If the vessel is an ampoule, preferably a glass ampoule, the delivery plunger is preferably designed as a shoulder element. As already described above, it is advantageous if the glass ampoule on the ampoule base is opened. The ampoule head accordingly points in the direction of the delivery piston. A shoulder element is preferred because the shoulder element does not attach to the ampoule head, but rather to the ampoule body. The shoulder element is designed in such a way that contact only occurs with one shoulder, but not with the ampoule head of the vessel. The shoulder element is shaped like a tube, the cavity having such a large diameter that the ampoule head, but not the shoulder of the vessel, can be accommodated in the shoulder element. The shoulder element thus protects the ampoule head from uncontrolled breaking off. As a result, the force applied by the delivery piston does not act on the predetermined breaking point and the ampoule head remains on the ampoule body with the advantages already described above. According to the invention, the delivery piston can be provided with a screwing means on an end facing away from the vessel. The screw means is able to effect the axial displacement of the delivery piston via a thread. The screwing means can preferably be designed as a handle, so that the force input is easier for the user to apply. In one embodiment, the screw means can have an internal thread and the first container can have an external thread, the threads being positive and / or non-positive cooperate to push the vessel onto the opening device by means of the delivery piston.

A further embodiment of the device according to the invention is characterized in that the first container can be inserted at least partially axially into the second container. According to the invention, the term “insertable” is understood to mean that a cross-sectional extent of the first container can be completely accommodated in the second container. A total length of the device is shortened by the insertion of the first container into the second container by the length of the first container, which is shifted into the second container. By first moving the first container into the second container, after opening the vessel and flowing the monomer liquid from the vessel into the second interior, the monomer fluid can be conveyed from the second interior into the first interior. After the first shift, the bone cement formed from bone cement powder and monomer liquid forms in the first interior. In a preferred embodiment, the formed bone cement can then be discharged from the device by a second displacement of the first container into the second container. This has the advantage that both the formation and the removal of the bone cement are carried out sequentially with a similar work step, in particular without additional external equipment or conversion measures. This prevents the user from confusing work steps. Another advantage of inserting the first container into the second container is that the vessel does not have to be completely destroyed. After the selective opening of the vessel, no more force has to be applied to the vessel, the vessel can rather be left intact up to the opened position. On the one hand, this reduces the effort required by the user of the device, and on the other hand, the breakage of the vessel with the disadvantages described above.

A further embodiment of the device according to the invention is characterized in that the first container has an external thread and the second container has an internal thread, the external thread and the internal thread being positively and / or non-positively connected or connectable to one another. External and internal threads interact in such a way that the first container can be moved into the second container by means of a relative rotary movement of the two containers to one another. In general, the first container can be shifted into the second container in different ways. For example, the first container can be pushed in by pressing on an end facing away from the second container. An advantage of shifting by means of external and internal threads is that the effort required by the user can be reduced. It is preferred if the external and / or internal threads are designed to be self-locking, so that the relative rotation of the two containers relative to one another can only be carried out in the direction of the displacement of the first container into the second container. On the one hand, the self-locking can further reduce the effort required by the user, since no force has to be used to prevent the first container from turning back out of the second container. On the other hand, self-locking increases the risk of a user error, since once the device has been used can only ever run in a predetermined direction. Inclusion of air bubbles in the bone cement can thus be avoided, for example.

Another embodiment of the device according to the invention is characterized in that the device has a fluid-conducting conveying means. According to the invention, a fluid-conducting conveying means is to be understood as a structure which separates interior spaces of a container from one another in such a way that gas and liquid exchange can take place between the interior spaces, but an exchange of solids is essentially prevented. Examples of fluid-conducting conveyors are pore disks, sieves, nets and membranes.

1. a. Öffnen des Gefäßes,
2. b. Fließen der Monomerflüssigkeit um den Austragskolben herum in den zweiten Innenraum,
3. c. Fördern der Monomerflüssigkeit aus dem zweiten Innenraum in den ersten Innenraum durch eine erste Verschiebung des ersten Behältnisses in das zweite Behältnis,
4. d. Ausbildung des Knochenzements aus Knochenzementpulver und Monomerflüssigkeit.

A second object of the present invention relates to a method for providing a bone cement from two starting components by means of a device comprising a hollow cylindrical first container in which a monomer liquid is stored as the first starting component, a hollow cylindrical second container having a container wall, a first interior and a second interior, wherein a bone cement powder is stored in the first interior as a second starting component, and wherein the monomer liquid can be conveyed into the second interior, a fluid-conducting conveying means arranged between the first interior and the second interior, the first container and the second container being axially connected to one another, at least comprising the following sequential substeps:

1. a. Opening the vessel,
2. b. Flow of the monomer liquid around the discharge piston into the second interior,
3. c. Conveying the monomer liquid from the second interior into the first interior by a first displacement of the first container into the second container,
4. d. Formation of bone cement from bone cement powder and monomer liquid.

A further embodiment of the method according to the invention is characterized in that the bone cement is removed from the device in a sub-step e) by a second displacement of the first container into the second container. The bone cement can generally be discharged from the device in different ways. For example, the discharge can be carried out by levers attached to the second container or by a separate, extra-connected discharge pump. It is preferred that the discharge can take place without separate external equipment and without additional components on the device itself. The second displacement of the first container into the second container means that no separately required discharge pumps and also no additional components, such as levers, are necessary. An advantage is thus that the use of the device is simplified and there is a lower risk of an error during use.

The device according to the invention is characterized in that it provides bone cements from two starting components. According to the invention, a bone cement is understood to be a substance which is suitable in the field of medical technology for establishing a stable connection between artificial joints, such as hip and knee joints, and bone material. Bone cements are preferably polymethyl methacrylate bone cements (PMMA bone cements). PMMA bone cements have long been used in medical applications and can be traced back to the work of Sir Charnley (cf. Charnley, J. Anchorage of the femoral head prosthesis of the shaft of the femur. J. Bone Joint Surg. 1960; 42, 28-30. ). PMMA bone cements can be produced from a bone cement powder as the first starting component and a monomer liquid as the second starting component. With a suitable composition, the two starting components can be stable in storage separately from one another. When the two starting components are brought into contact, swelling of the polymer components of the bone cement powder produces a plastically deformable bone cement, which is also referred to as a bone cement paste. Polymerization of the monomer by radicals is initiated. As the monomer continues to polymerize, the viscosity of the bone cement increases until it hardens completely.

According to the invention, a bone cement powder is understood to be a powder which comprises at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer. Examples of copolymers are styrene and / or methyl acrylate. In one embodiment, the bone cement powder can additionally comprise a hydrophilic additive, which supports the distribution of the monomer liquid within the bone cement powder. In a further embodiment, the bone cement powder can additionally comprise an initiator which initiates the polymerization. In a further embodiment, the bone cement powder can additionally comprise an X-ray opaque. In yet another embodiment, the bone cement powder can additionally comprise pharmaceutically active substances, such as antibiotics.

The bone cement powder preferably comprises at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer, an initiator and an X-ray opaque or consists of these components. The bone cement powder further preferably comprises at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer, an initiator, an X-ray opaque and a hydrophilic additive or consists of these components. Most preferably, the bone cement powder comprises at least one particulate polymethyl methacrylate and / or a particulate polymethyl methacrylate copolymer, an initiator, an X-ray opaque, a hydrophilic additive and an antibiotic or consists of these components.

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

According to the invention, the hydrophilic additive can be particulate and / or fibrous. In a further embodiment, the hydrophilic additive can be sparingly soluble, preferably insoluble, in methyl methacrylate. In a further embodiment, the hydrophilic additive can have an absorbency of at least 0.6 g of methyl methacrylate per gram of hydrophilic additive. In a further embodiment, the hydrophilic additive can have a chemical substance with at least one OH group. It can preferably be provided that the hydrophilic additive has covalently bonded OH groups on its surface. Examples of such preferred hydrophilic additives can be additives selected from the group comprising cellulose, oxycellulose, starch, titanium dioxide and silicon dioxide, with pyrogenic silicon dioxide being particularly preferred. In one embodiment, the particle size of the hydrophilic additive can correspond to the sieve fraction of less than 100 μm, preferably less than 50 μm and most preferably less than 10 μm. The hydrophilic additive can be contained in an amount of 0.1 to 2.5% by weight based on the total weight of the bone cement powder.

According to the invention, the initiator can contain dibenzoyl peroxide or consist of dibenzoyl peroxide.

According to the invention, an X-ray opaque is understood to be a substance which makes it possible to make the bone cement visible on X-ray diagnostic images. Examples of X-ray opaques can include barium sulfate, zirconia, and calcium carbonate.

According to the invention, the pharmaceutically active substance can comprise one or more antibiotics and optionally added co-factors for the one or more antibiotics. The pharmaceutically active substance preferably consists of one or more antibiotics and optionally added co-factors for the one or more antibiotics. Examples of antibiotics include gentamicin, clindamycin and vancomycin.

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

Examples

The invention is further illustrated below by examples. The invention is not restricted to the examples.

Figure list

• 1 schematic drawing of a cross section of a device for providing a bone cement from two starting components
• 2nd the device 1 rotated 90 ° to the right
• 3rd the device 2nd when opening a container with monomer liquid
• 4th the device 3rd when conveying the monomer liquid into a first interior
• 5 Device off 4th in the formation of the bone cement
• 6 Device off 5 when discharging the bone cement
• 7 Device off 6 after completion of the discharge process
• 8th Flow chart (method for providing a bone cement from two starting components)

Description of the figures

1 shows a device 100 in an initial state. The device 100 is in one piece, but made up of several components. The device 100 has a first container 200 and a second container 300 on. The device 100 is tubular. The first container 200 and the second container 300 are axially connected. The first container 200 and the second container 300 are common on the middle of the device 100 arranged. The first container 200 protrudes into the second container 300 inside. The first container 200 seals the second container 300 to the surroundings of the device 100 from.

The first container 200 owns on part of an outer surface 201 an external thread 240 . At a first end 202 of the first container 200 is a screwdriver 231 arranged. The screwdriver 231 encloses the first end 202 of the first container 200 hood-like. The screwdriver 231 has an internal thread 232 , which is positive and / or non-positive with the external thread 240 cooperates. The screwdriver 231 is designed as a handle. The force input for turning the first container in the opposite direction is the handle 200 against the second container 300 easier for the user to apply. The internal thread 232 is not entirely on the external thread 240 turned up so that a cavity A 235 between screw means 231 and first container 200 consists. On the screw 231 is a delivery piston 230 arranged in the form of a shoulder element. The delivery piston is H-shaped in cross section. The delivery piston 230 protrudes from the first end 202 in the first container 200 inside. The delivery piston 230 in the form of a shoulder element is designed so that contact only with one shoulder 212 , but not with a head 213 of a vessel 210 can come about. The delivery piston 230 is shaped like a tube, the cavity having such a large diameter that the head 213 of the vessel 210 , but not the shoulder 212 of the vessel 210 can be included. The delivery piston thus protects 230 the head 213 of the vessel 210 before an uncontrolled abort. The delivery piston 230 can only be on the shoulder 212 of the vessel 210 act. The first container 200 has a second end 203 with an opening device 220 in the form of a piercing spike.

In the first container 200 is a monomer liquid 211 stored. The monomer liquid 211 is in the vessel 210 stored in the form of a glass ampoule. The container 210 is preferably shaped as a glass ampoule, because the monomer liquid 211 can be stored hermetically sealed and sterile in a glass ampoule. The container 210 is also preferably formed as a glass ampoule, because a Glass ampoule can be opened easily. The container 210 is between the opening device 220 and the delivery piston 230 stored such that the vessel 210 not free yourself in the first container 210 can move. This causes an uncontrolled movement of the vessel 210 and thus prevents accidental breakage or opening of the vessel. The container 210 , the opening device 220 and the first container 200 form a cavity B 236 out.

On an outside of the second end 203 of the first container 200 is a discharge piston 400 appropriate. The discharge piston 400 is on an upper side facing the first container 401 cambered. The discharge piston 400 is firm with the first container 200 connected. The discharge piston 400 is positive and / or non-positive with the first container 200 connected. The discharge piston is with a screw device 410 with the second end 203 of the first vessel 200 connected. The discharge piston 400 and the first vessel 200 are designed in one piece. The discharge piston 400 borders with an outer surface 420 on a container wall 310 of the second container 300 . The discharge piston faces on the outer surface 420 two sealing rings 430 on.

The second container has a first end 301 an internal thread 302 . On the internal thread 302 is a threaded sleeve 303 with an internal thread 350 upset. The internal thread 350 can be positive and / or non-positive with the external thread 240 work together. The threaded sleeve 303 forms with the internal thread 202 and the external thread 350 a co-axial double thread pairing. By using the threaded sleeve 303 can be the first container 200 with a smaller diameter than without using the threaded sleeve 303 be trained. This reduces the risk of wedging between the first container 200 and second container 300 when using the device 100 . The threaded sleeve 303 prevents the first container from being completely pulled apart 200 from the second container 300 , because the threaded sleeve has an undercut for the second end 203 of the first vessel 200 forms. The second end 203 of the first vessel 200 has an outer diameter and the threaded sleeve 303 an inner diameter, the outer diameter of the first end 203 larger than the inside diameter of the threaded sleeve 303 is. This reduces the risk of accidental opening and thus contamination of the device 100 . The second container 300 has a first interior 320 and a second interior 330 . In the first interior 320 is a bone cement powder 321 stored. The entire second interior 330 is with the bone cement powder 321 filled out. The bone cement powder 321 is in the first interior 320 that compacted the bone cement powder 321 is not freely movable. In the spaces between the bone cement powder 321 there is a gas. The first interior 320 is with the second interior 330 via a fluid-conducting funding 340 connected. The grant 340 is permeable to gases and liquids, but impermeable to solids, such as the bone cement powder 321 , designed. The grant 340 points in the direction of the container wall 310 two sealing rings 341 on.

The second interior 330 borders the discharge piston in an upper area 400 . The discharge piston 400 is in a first position at the level of a first section 311 of the second container 300 . The first section 311 has at least one depression 312 in the container wall 310 . The deepening 312 runs in the axial direction of the second container 300 . The deepening 312 has a longer axial extent than the discharge piston 400 . The deepening 312 is designed such that the monomer liquid 211 the discharge piston 400 at the level of the first section 311 flow around and so into the second interior 330 can reach.

2nd shows the device 100 out 1 rotated 90 ° to the right. The screwdriver 231 is shaped as a handle for one hand. To prevent the delivery piston from being screwed in unintentionally 230 to prevent is directly below the screw 231 on the external thread 240 a fuse 234 appropriate. The fuse 234 blocks the external thread 240 for the screwdriver 231 . With fuse attached 234 it is not possible to use the internal thread 232 of the screwdriver 231 completely on the external thread 240 to turn. With fuse attached 234 the cavity A remains 235 between screw means 231 and first container 200 consist. The delivery piston can thus 230 the container 210 not on the opening device 220 press. With fuse attached 234 a cavity B remains 236 between opening device 220 , Vessel 210 and first container 200 . The fuse 234 can be perpendicular to the longitudinal axis of the device 100 pull off. The axial extension of the cavity A 235 is so long that the screwdriver is turned down 231 on the external thread 240 , and thus a conveying of the vessel 210 on the opening device 220 , the structural integrity of the vessel 210 punctually destroyed. The axial extension of the cavity A 235 is short enough so that the vessel 210 only punctured punctually, but not completely destroyed. An axial extension of the cavity B 236 is advantageously at least as long as an axial extension of the cavity A. 235 , because by turning the screw down 231 the container 210 can only be opened selectively.

3rd shows compared to 2nd , the device 100 after removing the fuse 234 (see. 2nd ) and with the delivery pistons turned down 230 . The screwdriver 231 was completely on the external thread 240 turned up. The screwdriver 231 was so on the external thread 240 turned on so that no cavity A 235 (see. 2nd ) more between screws 231 and external thread 240 consists. The delivery piston 230 has the vessel 210 in a first movement onto the opening device 220 pushed and thus opened. The delivery piston has the vessel 210 so on the opening device 220 pressed that no cavity B 236 (see. 2nd ) more between the first container 200 , Opening device 220 and vessel 210 consists. The opening device 220 has the structural integrity of the vessel 210 punctually destroyed. After unscrewing the screw 231 on the external thread 240 , and thus the opening of the vessel 210 , has a continued counter-rotation of the first container 200 against the second container 300 no effect on the device 100 . This serves to reduce security risks due to incorrect use of the device 100 . The screwing down 231 on the external thread 240 only serves to open the vessel 210 . Further process steps must be initiated separately. This prevents a user of the monomer liquid 211 after opening the vessel 210 not enough time out of the vessel 210 in the second interior 330 to flow. The second interior 330 is spatially above the first interior 320 arranged. Through the opening of the vessel 210 the monomer liquid flows 211 according to the gravity from the vessel 210 . The monomer liquid 211 flows through gravity through at least one bushing 250 in the bottom of the first vessel 200 towards the discharge piston 400 . The discharge piston is in the first position at the level of the first section 311 . The monomer liquid 211 flows around the discharge piston 400 through the wells 312 in the container wall 310 in the second interior 330 . The monomer liquid 211 flows around the discharge piston 400 by means of the wells 312 in the first section 311 . The second interior 330 comprises a volume which is at least the volume of the monomer liquid 211 corresponds. The second interior 330 can the entire monomer liquid 211 record, tape.

4th shows compared to 3rd , a pushing together by means of a first axial displacement of the first container 200 in the second container 300 . In the course of the first axial shift, the first container became 200 in a first step into the second container 300 over a distance corresponding to a length of an area 241 of the first container 200 pressed down without external thread. The length of the area 241 is so long that the discharge piston 400 from the height of the first section 311 to the level of a second section 315 is moved. The second section 315 has no depressions in the container wall 310 on. The discharge piston 400 separates at the level of the second section 311 the second interior 330 fluid impermeable towards the first container 200 from. The first step is to use the monomer liquid 211 tight in the second interior 330 compared to the first container 200 cut off. The first step of the first axial displacement thus serves to reduce safety risks due to incorrect use of the device 100 . The first step of the first axial displacement ensures that the whole is in the second interior 330 flowed monomer liquid 211 is available for further process steps and not back into the first container 200 can flow.

After completing the first step, the device 100 rotated so that the first interior 320 spatially above the second interior 330 is arranged. This has the advantage of a subsequent delivery of the monomer liquid 211 in the first interior 320 runs from the bottom to the top. Thus, a gas that is between the individual particles of the bone cement powder 321 is present when pumping the monomer liquid 211 in the first interior 320 dodge upwards, which reduces the risk of air pockets in the bone cement.

The external thread acts in a second step of the first axial displacement 240 of the first container 200 by rotation about the longitudinal axis of the device 100 positive and / or non-positive with the internal thread 302 of the second container 300 together. The interaction can take place either through direct contact of the internal thread 302 with the external thread 240 , or through an action of the threaded sleeve 303 respectively. The interaction between the threaded sleeve is shown in the figure 303 . The first axial displacement is subsequently carried out by rotating the first container in opposite directions 200 relative to the second container 300 continued. The device 100 is designed such that the counter-rotation of the first container relative to the second container 300 can only take place in the direction of the first axial displacement. The device 100 is designed such that after the second step of the first axial displacement has been inserted, the first container 200 and the second container 300 cannot be turned apart again. On the one hand, this has the advantage that a user does not have to apply any additional force to turn the device back 100 to prevent. On the other hand, the risk of air bubbles forming is reduced.

By the first axial displacement of the first container 200 in the second container 300 is the discharge piston 400 from the first section 311 into a second section 315 been postponed and a promotion of the monomer liquid 211 in the first interior 320 has started. By a continued first axial displacement of the first container 200 in the second container 300 becomes the monomer liquid from the second interior 330 about the funding 340 in the bone cement powder 321 in the first interior 320 pressed.

5 shows the device 100 after completion of the first axial displacement. The first axial displacement is complete when the discharge piston 400 the grant 340 reached. Reaching the grant 340 becomes a user of the device 100 due to an increased back pressure in the course of the counter-rotation of the first container 200 against the second container 300 displayed. On the one hand is the funding 340 so tight in the second container 300 arrested that the bone cement powder 321 condenses in the first interior 320 is storable and a user feels a noticeable back pressure upon completion of the first axial displacement. On the other hand is the funding 340 light enough in the second container 300 slidable so that a user has no difficulty moving the conveyor 340 in the further use of the device 100 Has. The grant 340 has two sealing rings on an outer surface 341 on. The sealing rings 341 guarantee a compromise between firm locking and easy displacement of the conveyor 340 . The entire monomer liquid 211 is in the first interior 320 been promoted. The monomer liquid 211 has the gas in the gaps between the bone cement powder 321 repressed. The gas in the spaces between the bone cement powder 321 is in the direction of a discharge opening 500 which is adjacent to the first interior 320 is arranged, pushed. The discharge opening 500 is with a locking pin 501 Mistake. The locking pin 501 prevents unwanted discharge of the bone cement powder 321 from the device 100 . The locking pin 501 is for gases and optionally also for the monomer liquid 211 designed permeable. The gas from the gaps between the bone cement powder 321 is through the locking pin 501 from the device 100 been driven out.

After the first axial displacement is complete, all of the bone cement powder is 321 from the monomer liquid 211 wetted. After wetting the bone cement powder completely 321 through the monomer liquid 211 the volume of the bone cement powder expands 321 out. When expanding the bone cement powder 321 becomes the locking pin 501 partly from the discharge opening 500 expelled. This shows the user that the device is functioning properly 100 and complete wetting of the bone cement powder 321 with the monomer liquid 211 at. By mixing bone cement powder 321 and monomer liquid 211 a bone cement forms 322 out. Merging bone cement powder 321 and monomer liquid 211 results in swelling of the bone cement powder 321 .

6 shows the device 100 in the course of a second axial displacement of the first container 200 in the second container 300 . The locking pin 501 (see. 5 ) was through a discharge cannula 502 replaced. The second axial displacement is caused by continued counter rotation of the first container 200 against the second container 300 about the longitudinal axis of the device 100 performed, the internal thread 350 the threaded sleeve 303 positive and / or non-positive with the external thread 240 cooperates. The discharge piston pushes in the course of the second axial displacement 400 the grant 340 towards the discharge opening 500 . By the second axial displacement of the first container 200 in the second container 300 becomes the bone cement 322 from the second interior 320 from the device 100 into the discharge cannula 502 promoted.

7 shows the device 100 after completion of the second axial displacement of the first container 200 in the second container 300 . The grant 340 is through the discharge piston 400 to the bottom of the second container 300 been pushed. The bone cement 322 is completely out of the device 100 been squeezed out. The discharge cannula 502 ensures the application of the bone cement 322 at the desired location. The discharge cannula 502 is still with remains of the bone cement 322 filled. The device 100 has by pushing the first container together 200 in the second container 300 assumed a shorter axial extent. The container 210 is after the discharge of the bone cement 322 not completely destroyed. The container 210 is after the discharge of the bone cement 322 through the opening device 220 only open selectively.

1 to 7 show the device 100 in the course of providing and mixing the starting components and removing the bone cement 322 . A user begins removing the fuse 234 from the external thread 240 of the first container 200 . The fuse 234 has the purpose of unintentionally opening the vessel 210 with the monomer liquid 211 to prevent. Is the fuse 234 removed, the user initially does not screw it completely onto the external thread 240 of the first container 200 screwed on 231 down. The screwdriver 231 acts on the delivery piston 230 one so that this continues into the first container 200 is inserted. In this respect, the delivery piston 230 axially movable in the first container 200 be arranged. Screwing the screwing agent 231 results in an axial movement of the delivery piston 230 towards the vessel 210 . The delivery piston transmits 230 - essentially - the axial movement of the screw 231 on the shoulder of the vessel 210 to put this on the opening device 220 to press and thus open selectively. The delivery piston 230 serves as a transmission medium in the thread when screwing on the screw 231 on the external thread 240 , arising in the device 100 directed force on the vessel 210 . The shoulder 212 of the vessel 210 is structurally so stable that the opening of the vessel 210 only adjacent to the opening device 220 happens. In a variant, the screw can be 231 only so far on the external thread 240 turn that vessel down 210 punctually, but not completely destroyed.

After unscrewing the screwdriver completely 231 on the external thread 240 Continued rotary movement does not lead to any further axial movement of the delivery piston 230 . Only the first container 200 can then about its longitudinal axis within the device 100 be rotated. Is the vessel 210 opened, the monomer liquid flows 211 from inside the vessel 210 towards the discharge piston 400 . As described above, the discharge plunger is 400 in the first position for the monomer liquid 211 permeable. To the monomer liquid 211 in the second interior 330 to promote the device 100 held so that the container 200 spatially above the second container 300 lies. This causes gravity to deliver the monomer liquid 211 in the second interior 330 exploited, which is why no external equipment, such as a pump or a vacuum connection, is necessary. To substantially complete transfer of the monomer liquid 211 in the second interior 330 to ensure the device 100 in the position described above, with the second container 300 down, a period of 60 seconds, in particular 30 seconds, preferably 10 seconds. To after pumping the monomer liquid 211 in the second interior 330 a backflow into the first container 200 to prevent the first container 200 at least partially into the second container by means of the first axial movement 300 inserted. This transfers the discharge piston 400 from the first position to the second position. Thus the monomer liquid 211 no longer through the deepening 312 towards the first container 200 flow back.

Then the device 100 rotated so that the second container 300 spatially above the first container 200 is arranged. This has the advantage that when the monomer liquid is subsequently conveyed 211 from the second interior 330 in the first interior 320 the gas that is in the second interior 330 and between the particles of the cement powder 321 located in the direction of the discharge opening 500 is ousted. This targeted directing of the gas in the direction of the discharge opening 500 the device 100 reduces the risk of gas inclusions within the mixed bone cement 322 .

To the monomer liquid 211 from the second interior 330 in the first interior 311 to promote, a force must be exerted on the discharge piston 400 towards the funding 340 . The external thread works for this 240 of the first container 200 with the internal thread 302 of the second container 300 together. The interaction can take place directly - ie positively and / or non-positively - or, as shown, by the participation of a threaded sleeve 303 . The user turns the screwdriver for this 231 such that the external thread 240 into the internal thread 350 the threaded sleeve 303 intervenes and the first container 200 via this rotary movement into the second container 300 is screwed in. The screwing in can preferably not be undone, which in turn reduces the formation of gas inclusions. A corresponding screw-back lock ensures that if there is an interruption in conveying, any in the device 100 forces do not increase the distance between the discharge pistons 400 and the funding 340 , in particular discharge opening 500 to care.

The first axial displacement is complete when the discharge piston 400 the grant 340 has reached, especially touched. At this point is the delivery of the monomer liquid 211 in the first interior 320 completed. The end of the first axial displacement is caused to the user by an increased back pressure when turning the screwing means 231 and by partially expelling the locking pin 502 displayed.

Before the user continues turning the screwdriver 231 initiates the second axial displacement, the device remains in the position described to form the bone cement 322 to ensure enough time. The time period depends on the composition and properties of the starting materials and can take from 5 seconds to 5 minutes. Then the second axial displacement of the first container 200 in the second container 300 initiated. Depending on the application site of the bone cement 322 it makes sense to use the device 100 at the discharge opening 500 before discharging the bone cement 322 with the discharge cannula 502 equip. The second axial displacement continues until the desired amount or the total bone cement 322 from the device 100 was held. The spatial orientation of the device 100 in the course of the second axial displacement, any choice can be made as required.

8th shows a flow chart containing the steps 610 to 650 of a process 600 for providing a bone cement from two starting components by means of the device 100 comprising the hollow cylindrical first container 200 in which the monomer liquid 211 as the first starting component in the vessel 210 stores the hollow cylindrical second container 300 showing the container wall 310 , the first interior 320 and the second interior 330 , being in the first interior 320 the bone cement powder 321 is stored as the second starting component, and wherein the monomer liquid 211 in the second interior 330 is eligible, the fluid-conducting funding 340 , arranged between the first interior 320 and the second interior 330 , being the first container 200 and the second container 300 are axially connected. In a preferred embodiment of the method 600 is the vessel 210 a glass ampoule due to its easy sterilization and good destructibility. In a further preferred embodiment of the method 600 is the discharge piston 400 at a first position within the second vessel 300 . The first position is characterized in that on the discharge piston 400 bordering container wall 310 Indentations 312 having.

In a first step 610 becomes the vessel 210 open. The vessel is preferred 210 only opened selectively and not completely destroyed. In a preferred embodiment of the method 600 is the first container 200 before the step 610 spatially above the second container 300 arranged so that the monomer liquid 211 according to gravity down towards the second container 300 can flow. In a further preferred embodiment of the method 600 takes place step 610 by turning down the delivery piston 230 which is the vessel 210 on the opening device 220 presses in the form of a piercing mandrel and thus opens selectively.

In a second step 620 the monomer liquid flows 211 out of the vessel 210 around the discharge plunger 400 around in the second interior 330 . In a further preferred embodiment of the step 620 flows around the monomer liquid 211 the discharge piston 400 over at least one well 312 in the container wall 310 . In a further preferred embodiment of the step 620 flows around the monomer liquid 211 the discharge piston 400 about recesses 312 in the form of a groove. In a preferred embodiment of the step 620 is the discharge piston 400 cambered so the entire monomer liquid 211 towards the wells 312 is directed.

In a third step 630 becomes the monomer liquid 211 from the second interior 330 in the first interior 320 by a first shift of the first container 200 in the second container 300 promoted. In a preferred embodiment of the step 630 the discharge plunger is inserted in a first step 400 from the first position to a second position. The second position is characterized in that on the discharge piston 400 bordering container wall 310 is designed without deepening. The monomer liquid 211 can the discharge piston 400 Do not flow around at the second position. The discharge piston 400 closes the second interior 330 at the second position for liquids and solids compared to the first container 200 from. In a further preferred embodiment of the step 630 becomes the device 100 after the first step rotated so that the second container 300 spatially above the first container 200 is arranged. This has the consequence that a between the particles of the bone cement powder 321 gas present in the further course of the process 600 More trouble-free, with reduced risk of air pockets, from the bone cement powder 321 through the monomer liquid 211 displaces. In a further preferred embodiment of the step 630 shows the first container 200 an external thread 240 and the second container 300 an internal thread 302 on, with external thread 240 and internal thread 302 can interact positively and / or non-positively around the first container 200 in the second container 300 to postpone. In a further preferred embodiment of the step 630 the device has a threaded sleeve 303 on. The threaded sleeve forms with the internal thread 302 and the external thread 240 a co-axial double thread pairing. The external thread acts in a second step of the first axial displacement 240 and the internal thread 302 , preferably over the threaded sleeve 303 , so together that the first container 200 in the second container 300 is inserted. The second step of the first axial displacement promotes the monomer liquid 211 from the second interior 330 in the first interior 320 .

In a fourth step 640 there is formation of the bone cement 322 from bone cement powder 321 and monomer liquid 211 . In a preferred embodiment of the step 640 starts the formation of the bone cement 322 with a wetting of the bone cement powder 321 through the monomer liquid 211 . After wetting, the bone cement powder swells 321 .

In an optional fifth step 650 is a second shift of the first container 200 in the second container 300 the bone cement 322 from the device 100 expelled. In a preferred embodiment of the step 650 the bone cement is expelled 322 from the device 100 via a continued counter-rotation of the first container 200 against the second container 300 . In a further preferred embodiment, the vessel is 210 after removal of the bone cement 322 not completely destroyed. In a further preferred embodiment of the method 600 is the vessel 210 after removal of the bone cement 322 only open selectively.

An advantage of the method according to the invention 600 is that the vessel 210 in the course of the mixing, and optionally the discharge, of the bone cement 322 does not have to be completely destroyed. On the one hand this reduces the effort required by the user, on the other hand the disadvantages of fragments of the vessel described above become 210 avoided. Another advantage of the method according to the invention 600 is that the substeps 630 and 650 run sequentially with similar process steps and there is no possibility to change or to confuse the order of the process steps. So that's the procedure 600 simple, safe and quick to implement.

1. 1. das Gefäß für die Monomerflüssigkeit öffnet,
2. 2. die Monomerflüssigkeit in das Knochenzementpulver fördert und
3. 3. den fertigen, mischungsfrei aus Monomerflüssigkeit und Knochenzementpulver gebildeten, Knochenzement austrägt.

In summary, it can be stated that the invention is characterized by a device which has two containers, the monomer liquid being stored in the first container and the bone cement powder in the second container. According to the invention, the first container is pushed into the second container, the axial insertion of the first container sequentially one after the other

1. 1. opens the vessel for the monomer liquid,
2. 2. promotes the monomer liquid in the bone cement powder and
3. 3. discharges the finished, cement-free, formed from monomer liquid and bone cement powder.

It is noted that embodiments of the invention are described with reference to various matters. In particular, some embodiments are described with reference to device claims, while other embodiments are described with reference to method claims. A person skilled in the art will, however, see from the above and the description that, unless stated otherwise, in addition to a combination of features which belong to one type of object, a combination of features which relate to different objects is also disclosed in this application are. All features can be combined with one another, which can lead to synergy effects that are greater than a simple addition of the feature effects.

While the invention has been illustrated and described in detail in the drawings and the description above, these figures and descriptions are to be regarded as illustrative or exemplary and in no way as restrictive. The invention is not limited to the disclosed embodiments. Variations of the disclosed embodiments may be understood and carried out by those skilled in the art upon studying the drawings, the disclosure, and the dependent claims.

In the claims, the word "comprehensive" does not exclude other elements or steps. The indefinite article "a" or "an" also does not exclude a large number. The mere fact that certain features are cited in independent claims does not suggest that a combination of these features cannot be used to advantage. Any reference signs in the claims should not be interpreted as limitations.

Reference list

100

contraption

200

first container

201

Outside surface of the first container

202

first end of the first container

203

second end of the first container

210

vessel

211

Monomer liquid

212

Shoulder of the vessel

213

Head of the vessel

220

Opening device

230

Delivery piston

231

Screwdriver

232

Internal thread of the screw

233

Shoulder element

234

Securing the delivery piston

235

Cavity A

236

Cavity B

240

External thread

241

Area without external thread

250

Implementations

300

second container

301

first end of the second container

302

Internal thread of the second container

303

Threaded sleeve

310

Container wall

311

first section

312

deepening

315

second section

320

first interior

321

Bone cement powder

322

Bone cement

330

second interior

340

Funding

341

Conveyor sealing rings

350

Internal thread of the threaded sleeve

400

Discharge piston

401

Top of discharge piston

410

Screwing device

420

Outer surface of the discharge piston

430

Discharge piston sealing rings

500

Discharge opening

501

Locking pin

502

Discharge cannula

600

Method of providing a bone cement

610

Opening the vessel

620

Flow of the monomer liquid

630

first shift of the first container into the second container

640

Formation of the bone cement

650

second shift of the first container into the second container

QUOTES INCLUDE IN THE DESCRIPTION

This list of documents listed by the applicant has been generated automatically and is only included for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• US 6033105 A [0002]
• US 5624184 A [0002]
• US 4671263 A [0002]
• US 4973168 A [0002]
• US 5100241 A [0002]
• WO 9967015 A1 [0002]
• EP 1020167 A2 [0002]
• US 5586821 A [0002]
• EP 1016452 A2 [0002]
• DE 3640279 A1 [0002]
• WO 9426403 A1 [0002]
• EP 1005901 A2 [0002]
• EP 1886647 A1 [0002]
• US 5344232 A [0002]
• EP 0692229 A1 [0003]
• DE 102009031178 B3 [0003]
• US 5997544 A [0003]
• US 6709149 B1 [0003]
• DE 69812726 T2 [0003]
• EP 0796653 A2 [0003]
• US 5588745 A [0003]
• DE 102016121607 A1 [0004]

Non-patent literature cited

• Charnley, J. Anchorage of the femoral head prosthesis of the shaft of the femur. J. Bone Joint Surg. 1960; 42, 28-30. [0030]

Claims (15)

Device (100) for providing a bone cement (322) comprising two starting components, comprising a hollow cylindrical first container (200) in which a monomer liquid (211) can be stored as the first starting component, a hollow cylindrical second container (300) having a container wall (310) , a first interior (320) and a second interior (330), wherein a bone cement powder (321) can be stored as a second starting component in the first interior (320), and wherein the monomer liquid (211) can be conveyed into the second interior (330) , a fluid-conducting conveying means (340) arranged between the first interior (320) and the second interior (330), the first container (200) and the second container (300) being axially connected to one another, characterized by an axially in the second container (300) displaceable discharge piston (400), arranged between the first container (200) and the second interior space (330), the discharge piston (400) cooperates with the container wall (310) such that in a first position of the discharge piston (400) the first container (200) and the second interior (330) are fluid-conducting for the monomer liquid (211), and in a second position of the discharge piston (400), the first container (200) and the second interior (330) are not connected in a fluid-conducting manner for the monomer liquid (211). Device (100) after Claim 1 , characterized in that the container wall (310) has a first section (311) with at least one depression (312) and a second section (315), which is designed without a depression. Device (100) after Claim 2 , characterized in that the discharge piston (400) adjoins the first section (311) in the first position such that the discharge piston (400) can be flowed around by the monomer liquid (211) via the at least one recess (312). Device (100) after Claim 2 or 3rd , characterized in that the discharge piston (400) adjoins the second section (315) in the second position such that the discharge piston (400) cannot flow around the monomer liquid (211). Device (100) according to one of the preceding claims, characterized in that the discharge piston (400) is cambered. Device (100) according to one of the preceding claims, characterized in that the first container (200) and the discharge piston (400) are designed in one piece. Device (100) according to one of the preceding claims, characterized in that the first container (200) contains a vessel (210) with the monomer liquid (211). Device (100) after Claim 7 , characterized in that the first container (200) has an opening device (220) for the vessel (210). Device (100) after Claim 7 or 8th , characterized in that the vessel (210) is a glass ampoule. Device (100) after Claim 9 , characterized in that the opening device (220) is a piercing spike. Device (100) according to one of the Claims 8 to 10th , characterized in that the first container (200) comprises an axially displaceable delivery piston (230), configured in such a way that the vessel (210) can be delivered to the opening device (220) by the delivery piston (230). Device (100) according to one of the preceding claims, characterized in that the first container (200) can be inserted at least partially axially into the second container (300) such that the discharge piston (400) extends over the length of the second interior (330). and at least part of the length of the first interior (320) is movable. Device (100) according to one of the preceding claims, characterized in that the first container (200) has an external thread (240) and the second container (300) has an internal thread (302), the external thread (240) and the internal thread (302 ) are positively and / or non-positively connected or connectable. Method (600) for providing a bone cement (322) from two starting components by means of a device (100) comprising a hollow cylindrical first container (200) in which a monomer liquid (211) is stored as a first starting component in a vessel (210), a hollow cylindrical second Container (300) comprising a container wall (310), a first interior space (320) and a second interior space (330), a bone cement powder (321) being stored as a second starting component in the first interior space (320), the monomer liquid (211) in the second interior (330) is conveyable, a fluid-conducting Conveying means (340) arranged between the first interior (320) and the second interior (330), and wherein the first container (200) and the second container (300) are axially connected to one another, at least comprising the following sequential substeps: a. Opening the vessel (210), b. Flowing the monomer liquid (211) around the discharge piston (400) into the second interior (330), c. Delivery of the monomer liquid (211) from the second interior (330) into the first interior (320) by a first displacement of the first container (200) into the second container (300), i. Formation of the bone cement (322) from bone cement powder (321) and monomer liquid (211). Method (600) according to Claim 14 , characterized in that the bone cement (322) is discharged from the device (100) in a partial step e) by a second displacement of the first container (200) into the second container (300).

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