TWO-PART STORAGE AND MIXING DEVICE FOR THE PRODUCTION OF A BONE CEMENT, AND PERTINENT METHOD

Abstract

A storage and mixing device for the production of a bone cement dough from a monomer liquid and a cement powder as starting components of the bone cement. The storage and mixing device includes: (1) a receptacle having a monomer liquid container which contains the monomer liquid, (2) a cartridge containing the cement powder, (3) a feed plunger, which is accessible from a rear side of the receptacle, arranged in the receptacle, and movable in a longitudinal direction of the receptacle, and (4) a dispensing plunger which is arranged in the cartridge and shiftable in a longitudinal direction inside of the cartridge. The front side of the receptacle is connected or connectable to the rear side of the cartridge with a first securing element on the rear side of the receptacle and a second securing element on the rear side of the cartridge.

The invention also relates to a method for the production of a bone cement dough, in particular of a pasty polymethylmethacrylate bone cement dough, whereby the bone cement dough is produced from a cement powder and a monomer liquid through the use of a storage and mixing device.

Claims

1. A storage and mixing device for the production of a bone cement dough from a monomer liquid and a cement powder as starting components of the bone cement, the storage and mixing device comprising: a receptacle, having a monomer liquid container containing the monomer liquid, a cartridge containing the cement powder, a feed plunger contacting in the receptacle, whereby the feed plunger is movable in a longitudinal direction of the receptacle and is accessible from a rear side of the receptacle, and a dispensing plunger in the cartridge, whereby the dispensing plunger is movable in a longitudinal direction within the cartridge, whereby: a front side of the receptacle is connected or connectable to a rear side of the cartridge such that an internal space of the receptacle is in fluid communication with an internal space of the cartridge such as to be permeable to the monomer liquid, the connection is detachable, and a first securing element is provided on the rear side of the receptacle and a second securing element is provided on the rear side of the cartridge, whereby the first securing element and the second securing element are identical or congeneric.

2. The storage and mixing device according to claim 1, wherein, the dispensing plunger includes: a closable feedthrough: (1) in fluid communication with an internal space of the cartridge, and (2) including a valve, at least two sealing lips, or a self-closing puncturable membrane, whereby, the closable feedthrough is adapted to be closable in liquid tight manner upon the connection between the receptacle and the cartridge being detached.

3. The storage and mixing device according to claim 2, wherein the front side of the receptacle includes: a hollow needle or a tube adapted to connect the inside of the receptacle to the internal space of the cartridge, whereby, the hollow needle or the tube, together with the closable feedthrough, form a liquid permeable connection into the internal space of the cartridge when the receptacle is connected to the cartridge.

4. The storage and mixing device according to claim 2, wherein the front side of the receptacle includes: a connecting plunger, whereby: (1) the connecting plunger is movable in the longitudinal direction within the receptacle, (2) whereby the monomer liquid container is arranged between the connecting plunger and the feed plunger, (3) a passage that is permeable to the monomer liquid and gases is provided in the connecting plunger and the passage is in fluid communication with the internal space of the cartridge, and (4) a motion of the connecting plunger in the direction of the cartridge that is connected to the front side of the receptacle causes the closable feedthrough on the rear side of the cartridge.

5. The storage and mixing device according to claim 1 wherein the front side of the receptacle includes: a screen or a porous disk that is permeable to gases and liquids and is in fluid communication with the cartridge.

6. The storage and mixing device according to claim 1 wherein, the storage and mixing device is a bone cement applicator for storage and mixing of the starting components and for application of the bone cement dough in the area of the spine, whereby the bone cement applicator further comprises an extended dispensing opening connected to the front side of the cartridge, and the extended dispensing opening includes a dispensing tube, a hose, a trocar, or a combination thereof.

7. The storage and mixing device according to claim 6, further comprising: a three-way valve that is: (1) adapted to be moves between a first position and a second position, (2) operable from outside, and (3) is located in the extended dispensing opening or between the extended dispensing opening and the cartridge, a collecting container, for reception of bone cement dough, in fluid communication with the three-way valve, whereby, the extended dispensing opening merges into an application opening at the end of the extended dispensing opening opposite the cartridge, and whereby, when the three-way valve in the first position, the three-way valve opens a fluid passage between the application opening and the cartridge and closes a discharge channel extending toward the collecting container, and when the three-way valve is in the second position, the three-way valve opens the discharge channel and closes the fluid passage.

8. The storage and mixing device according to claim 1 wherein the receptacle further comprises: at least one hollow needle or at least one tube on the front side of the receptacle whereby the receptacle is connected or connectable to the internal space of the cartridge through the needle or tube, and the receptacle is adapted to be liquid-tight except for the needle or tube.

9. The storage and mixing device according to claim 1, wherein, the monomer liquid container is a glass ampoule, a plastic ampoule, a plastic film bag, or an aluminium-plastic compound bag which is openable in the inside of the receptacle.

10. The storage and mixing device according to claim 1 wherein, the first securing element and the second securing element is securable to a single holder of a cartridge gun.

11. The storage and mixing device according to claim 1 wherein, the cross-section of the internal space of the cartridge is at most 4 cm.sup.2.

12. The storage and mixing device according to claim 1 wherein, the cartridge is closed on the front side by a cartridge head, an outlet opening is situated in the cartridge head, and the outlet opening is closed by a closure which is impermeable to the cement powder in the cartridge and which is permeable to gas, whereby the closure is openable through an axial pressure load or by action of a manual force.

13. The storage and mixing device according to claim 1 wherein, the receptacle is closed or closable on the rear side by the feed plunger in liquid-tight manner.

14. The storage and mixing device according to claim 1 wherein, the cartridge is hollow cylinder-shaped and the second securing element is adapted to be connected to an extrusion device, whereby: (1) a cartridge head closes the front side of the hollow cylinder-shaped cartridge, (2) the cartridge head includes an outlet opening, and (3) the outlet opening connects the outside of the cartridge head to the inside of the cartridge head in gas-permeable manner, whereby a dispensing tube is connected to the outlet opening on the cartridge head, and a puncturable membrane is adapted to close the rear side of the dispensing plunger in a liquid-impermeable manner, and the receptacle is hollow cylinder-shaped, whereby, the connecting plunger includes: (1) a porous disk, which is permeable to gases and liquids, and (2) at least one hollow needle on the front side of a connecting plunger connected to the rear side of the porous disk by a channel.

15. The storage and mixing device according to claim 1 wherein, the volume of the monomer liquid in the monomer liquid container is at least as large as the volume of the air-filled intervening spaces between the cement powder particles in the cartridge.

16. The storage and mixing device according to claim 1 wherein, a wall of the receptacle includes at least one ventilation opening, whereby: (1) the ventilation opening connects the internal space of the receptacle, in which the monomer liquid container is arranged, to the surroundings of the storing and mixing device, and (2) the ventilation opening is adapted to be closed by a motion of the feed plunger in the direction of the front side of the receptacle before the monomer liquid container is opened through the motion of the feed plunger.

17. The storage and mixing device according to claim 1 wherein, the cartridge has a compressive strength of more than 10 bar.

18. A method for the production of a bone cement dough from a cement powder and a monomer liquid using a storage and mixing device having a receptacle containing a monomer liquid container with the monomer liquid in it and a cartridge containing the cement powder, whereby the receptacle is secured or securable to the rear side of the cartridge, the method comprising: a) inserting the storage and mixing device in an extrusion device, having a pestle that is propellable in axial direction; b) propelling a feed plunger, supported such as to be mobile in the receptacle on the rear side thereof, in the direction of the cartridge by the pestle, whereby: (1) the motion of the feed plunger opens the monomer liquid container and presses the monomer liquid from the monomer liquid container into the cartridge, and (2) the cement powder mixes with the monomer liquid in the internal space of the cartridge; c) separating the receptacle from the cartridge, whereby the cartridge remains in the extrusion device or is reinserted into the extrusion device after the separation; d) propelling a dispensing plunger, supported in the cartridge on the rear side thereof such as to be mobile, in the direction of the front side of the cartridge by the pestle, whereby the motion of the dispensing plunger expels the mixture consisting of the cement powder and the monomer liquid from the cartridge in the form of the bone cement dough.

19. The method according to claim 18, wherein the method is implemented using a storage and mixing device according to claim 1.

20. The method according to claim 18, wherein the rear side of the cartridge includes a closable feedthrough through which the monomer liquid is pressed into the inside of the cartridge in step b), whereby, the closable feedthrough is being-closed when the receptacle is separated from the cartridge in step c) or closes self-actingly during the separation.

21. The method according to claim 18 wherein, a first securing element is provided on the rear side of the receptacle and a second securing element, is provided on the rear side of the cartridge, whereby, during the insertion of the storage and mixing device in step a), the storage and mixing device is secured to a holder of the extrusion device by the first securing element, and the cartridge is secured to the holder of the extrusion device by the second securing element in step c).

22. The method according to claim 18 wherein a connecting plunger is arranged on the front side of the receptacle, whereby: (1) the monomer liquid container is arranged between the connecting plunger and the feed plunger, (2) the connecting plunger is driven in the direction of the cartridge in step b), while the feed plunger is propelled and before the monomer liquid is pressed into the cartridge, (3) a passage into the cartridge is opened such that the internal space of the cartridge and the internal space of the receptacle are connected to each other between the feed plunger and the connecting plunger in liquid-permeable manner, and (4) a crushing force is applied to the liquid container through a motion of the feed plunger against the connecting plunger (20, 220) such that the liquid container is crushed and the monomer liquid is available in the internal space of the receptacle to be pressed into the cartridge.

23. The method according to claim 18 wherein the mixture of the cement powder and monomer liquid in step d) is pressed out of the cartridge and through an extended dispensing opening, a dispensing tube, a hose, a trocar, a static mixer, or a combination thereof, whereby the bone cement dough is produced in the cartridge, the extended dispensing opening, the dispensing tube, the hose, the trocar, or the static mixer.

24. The method according to claim 18 wherein, a three-way valve, that is: (1) adapted to be moves between a first position and a second position, (2) operable from outside, and (3) located in the extended dispensing opening or downstream from the cartridge, whereby when the three-way valve is brought into a first position or is in the first position, the three-way valve, provides a continuous connection from the internal space of the cartridge through the extended dispensing opening, and an extrusion of the cartridge by the extrusion device takes place in step d), whereby the bone cement dough mixed from the cement powder and the monomer liquid is pressed through the three-way valve and through the extended dispensing opening, and a subsequent step e) takes place, in which the three-way valve is transitioned into a second position, whereby the three-way valve, being in the second position, stops the flow from the cartridge through the three-way valve and a part of the pressurized bone cement dough downstream from the three-way valve in the extended dispensing opening is pressed through the three-way valve into a collecting container.

25. The method according to claim 24, wherein the three-way valve is moved to the first position again in a step f) after step e) causing the bone cement dough to be guided again through the three-way valve through the dispensing opening.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0127] The invention is best understood from the following detailed description when read in connection with the accompanying drawing. It is emphasized that, according to common practice, the various features of the drawing are not to scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Included in the drawing are the following figures:

[0128] FIG. 1 is a schematic cross-sectional view of one embodiment of a storage and mixing device;

[0129] FIG. 2 is a schematic side view of the storage and mixing device shown in FIG. 1.

[0130] FIG. 3 is four schematic cross-sectional views of the storage and mixing device shown in FIGS. 1 and 2 on top of each other for illustration of the workflow of one embodiment of the method;

[0131] FIG. 4 is a schematic cross-sectional view through the front part of the storage and mixing device shown in FIGS. 1 to 3 with an extended dispensing opening connected to it;

[0132] FIG. 5 is three schematic perspective views of parts of the storage and mixing devices shown in FIGS. 1 to 4;

[0133] FIG. 6 is a schematic cross-sectional view of a three-way valve for an extended dispensing opening shown in FIG. 4;

[0134] FIG. 7 is a schematic cross-sectional view of the three-way valve shown in FIG. 6 with a sectional plane perpendicular to the flow direction of the bone cement dough;

[0135] FIG. 8 is a schematic cross-sectional view of the connection of the two parts of the storage and mixing device during its use according to the 2nd figure from the top in FIG. 3;

[0136] FIG. 9 is a schematic cross-sectional view of the connection of the two parts of the storage and mixing device before dispensation according to the 4th figure from the top in FIG. 3;

[0137] FIG. 10 is a schematic perspective partial view (top) and a schematic partial cross-sectional view (bottom) of the rear side of the rear part of one embodiment of a storage and mixing device in the starting state;

[0138] FIG. 11 is two schematic perspective cross-sectional views through a valve system for an alternative storage and mixing device according to the invention, namely a three-way valve in closed position (FIG. 11 top) and in open position (FIG. 11 bottom);

[0139] FIG. 12 is two schematic cross-sectional top views through the valve system according to FIG. 11, namely the three-way valve in open position (FIG. 12 bottom) and in closed position (FIG. 12 top);

[0140] FIG. 13 is a schematic cross-sectional view through a third inventive exemplary embodiment of a storage and mixing device; and

[0141] FIG. 14 is a magnified detail view of the connection of the two parts of the third exemplary embodiment according to FIG. 13 before the start of the extrusion process.

DETAILED DESCRIPTION

[0142] The features and benefits of the disclosed material transport apparatus are illustrated and described by reference to exemplary embodiments. The disclosure also includes the drawing, in which like reference numbers refer to like elements throughout the various figures that comprise the drawing. This description of exemplary embodiments is intended to be read in connection with the accompanying drawing, which is to be considered part of the entire written description. Accordingly, the disclosure expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combinations of features that may exist alone or in other combinations of features.

[0143] In the description of embodiments, any reference to direction or orientation is merely intended for convenience of description and is not intended in any way to limit the scope of the present invention. Relative terms such as front, rear, lower, upper, horizontal, vertical, above, below, up, down, top, and bottom as well as derivatives thereof (e.g., horizontally, downwardly, upwardly, etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description only and do not require that the apparatus be construed or operated in a particular orientation. Terms such as attached, affixed, connected, coupled, interconnected, and similar terms refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both moveable or rigid attachments or relationships, unless expressly described otherwise.

[0144] FIGS. 1 to 5 show various schematic views of a first exemplary storage and mixing device according to the invention. FIGS. 6 and 7 show schematic cross-sectional views as detail views through a valve system that can be used as part of the inventive storage and mixing device according to FIGS. 1 to 5. FIGS. 8 to 10 show further detail views of the inventive storage and mixing device according to FIGS. 1 to 5.

[0145] The storage and mixing device has, as front part (on the top in FIGS. 1, 2, and 4, on the left in FIGS. 3, 5, 6, 8, and 9), a cartridge 1 made of plastics with a cylindrical internal space. The cartridge 1 is detachably connected to a receptacle 2 made of plastics for a glass ampoule 3 (or plastic ampoule 3). The receptacle 2 also comprises a cylindrical internal space into which the glass ampoule 3 is plugged. The monomer liquid 4 is situated in the glass ampoule 3. A cement powder 5 is filled or, preferably, pressed into the internal space of the cartridge 1. The monomer liquid 4 and the cement powder 5 are the starting components 4, 5 of a PMMA bone cement that can be produced with the storage and mixing device. Due to the glass ampoule 3, the monomer liquid 4 can be stored in the receptacle 2 and therefore in the storage and mixing device for very long times.

[0146] A feed plunger 6 made of plastics that is mobile in longitudinal direction in the cylindrical internal space of the receptacle 2 is arranged in the receptacle 2. The feed plunger 6 is arranged in the area of the rear side of the receptacle 2. The glass ampoule 3 can be compressed and thereby cracked in the receptacle 2 by the feed plunger 6 by pushing the feed plunger 6 in the direction of the front side, i.e. in the direction of the cartridge 1. The feed plunger 6 comprises, on its front side, wipers which may assist with wiping off fragments of the glass ampoule 3 from the internal wall of the receptacle 2.

[0147] A dispensing plunger 7 made of plastics is arranged in the rear side (toward the bottom in FIGS. 1, 2, and 4, toward the right in FIGS. 3, 5, 6, 8, and 9) of the internal space of the cartridge 1. A securing element 8 is provided on the rear side of the receptacle 2 and can be used to connect the receptacle 2 to an extrusion device 43 (not shown in FIG. 1, but in FIG. 3). A securing element 9 of identical design is provided on the rear side of the cartridge 1. Both the receptacle 2 and the cartridge 1 can therefore be secured to the same extrusion device 43. The securing elements 8, 9 are preferably suitable and provided for the formation of a bayonet lock 8, 9. As a result, the feed plunger 6, which is freely accessible from the rear side of the receptacle 2, can be driven forward in the direction of the front side using the same extrusion device 43 as the dispensing plunger 7, which is freely accessible from the rear side of the cartridge 1, when the cartridge 1 is not connected to the receptacle 2 (see, for example, FIG. 4).

[0148] The cartridge 1 and the receptacle 2 are detachably connected or are detachably connectable to each other via an external thread 10 on the front side of the receptacle 2 and an internal thread 11 on the rear side of the cartridge 1. The receptacle 2 and the cartridge 1 are connected to each other in liquid-permeable manner with respect to the monomer liquid 4 by a tube 12 made of a metal or of plastics or a feedthrough 14 in the dispensing plunger 7. The feedthrough 14 through the dispensing plunger 7 merges through a pore filter 16, which is impermeable to the cement powder 5, but permeable to the monomer liquid 4, into the internal space of the cartridge 1. Before entering the internal space of the cartridge 1, the feedthrough 14 branches into multiple arms, whereby the arms are not shown in the section according to FIG. 1 since they are not situated in the central plane of the storage and mixing device that is shown and shown in section therein.

[0149] A filter 18, by which the fragments of the glass ampoule 3 can be retained, is arranged in the connection to the tube 12 in the receptacle 2. Instead of the filter 18 or in addition to the filter 18, a screen can be provided just as well or also. The filter 18 is arranged in a connecting plunger 20 to which the tube 12 is secured as well. In this embodiment, the connecting plunger 20 touches against the front side of the receptacle 2 on the inside and serves only the purpose to facilitate the assembly of the storage and mixing device. Theoretically, the tube 12 and the filter 18 can just as well be affixed to the receptacle 2 and the connecting plunger 20 can be omitted.

[0150] The tube 12 is guided through a valve with three sealing lips 22 into the feedthrough 14 through the dispensing plunger 7. The three sealing lips 22 are implemented by a Y-shaped incision in an elastic plastic plug, whereby the plastic stopper forms the rear-side part of the dispensing plunger 7. In the starting state, the tube 12 is guided through said sealing lips 22, and the passage 14 is sealed in liquid-tight manner in the direction of the rear side by the sealing lips 22 touching against the tube 12. When the tube 12 is pulled out of the plug and/or the sealing lips 22, the sealing lips 22 seal the dispensing plunger 7, and thus the cartridge 1, on the rear side in liquid-tight manner.

[0151] The cylindrical connecting plunger 20 has an external circumference that matches the cylindrical geometry of the internal space of the receptacle 2 and is sealed by two circumferential seals 24 in liquid-tight manner with respect to the internal wall of the receptacle 2. Likewise, the feed plunger 6 is sealed in liquid-tight manner with respect to the internal wall of the receptacle 2 by two circumferential seals 26 and the dispensing plunger 7 is sealed in liquid-tight manner with respect to the internal wall of the cartridge 1 by two circumferential seals 28. Moreover, the cartridge 1 and the receptacle 2 are sealed with respect to each other by a seal 30 that is secured to the front surface of the receptacle 2, when the cartridge 1 and the receptacle 2 are secured to each other. The purpose of all of said seals 24, 26, 28, 30 is to prevent monomer liquid 4 or bone cement from exiting in order to prevent contamination of the surroundings (the OR theatre and the user). For this purpose, the seals 24, 26, 28, 30 can consist of rubber.

[0152] In addition, the receptacle 2 is surrounded by a housing 32 made of plastics, whereby the housing 32 is connected to the receptacle 2 and covers, on the front side, the securing element 9 of the cartridge 1, when the cartridge 1 is connected to the receptacle 2. The cartridge 1, the receptacle 2, and the housing 32 can be produced through injection molding.

[0153] The front side of the cartridge 1 merges into a dispensing tube 34 that comprises an external thread. A pore filter 36 that is impermeable to the cement powder 5, but is permeable to gases is arranged in the inside of the dispensing tube 34. A cap 38 is secured to the external thread of the dispensing tube 34, whereby the front part of the cap 38 is filled with a Styrofoam or foam 40. Two wings 42 are provided on the cap 38 such that the cap 38 can be unscrewed conveniently from the dispensing tube 34 in the way of a wing screw. The cap 38 comprises lateral openings. Due to this design, the inside of the cartridge 1 and the cement powder 5 can be sterilized with the aid of ethylene oxide, since the openings in the cap 38, the Styrofoam or foam 40, the pore filter 36, and the intervening spaces between the powder particles of the cement powder 5 are permeable to air. Concurrently, air can be pressed out of the receptacle through the cement powder 5, the pore filter 36, the Styrofoam or foam 40, and the openings in the cap 38, when the feed plunger 6 is pressed in the direction of the receptacle 2.

[0154] The cement powder 5 is enclosed in the cartridge 1, since all openings are closed by the pore filters 16, 36 such as to be impermeable to the cement powder 5. The content of the cartridge 1 can be sterilized by evacuation and rinsing with ethylene oxide in this context. As a result, the storage and mixing device is also well-suited for long-term storage of the cement powder 5.

[0155] FIG. 3 shows four schematic cross-sectional views of the storage and mixing device according to FIGS. 1 and 2 on top of each other for illustration of the workflow of a method according to the invention. At the outset of the method, the storage and mixing device is in the starting state that is also shown in FIG. 1. Accordingly, the cartridge 1 and the receptacle 2 of the storage and mixing device are initially connected to each other through the threads 10, 11. Being in this state, the storage and mixing device is inserted into an extrusion device 43 in the form of a conventional cartridge gun and is secured to the extrusion device 43 using the securing element 8 (see topmost depiction in FIG. 3). Only the front part of the extrusion device 43 is shown. The extrusion device 43 comprises a pestle 44 that can be propelled linearly. Preferably, the pestle 44 is driven manually. The pestle 44 ends, on its front side, in a cup 46 that can be used to push onto the feed plunger 6. For this purpose, the extrusion device 43 is connected to the rear side of the receptacle 2 through an opposite securing element 48 such that the cup 46 pushes onto the feed plunger 6 and propels it in the direction of the cartridge 1, when the pestle 44 is propelled forward. For this purpose, the pestle 44 is supported such as to be linearly mobile with respect to a bearing 50 and, by means of it, with respect to the opposite securing element 48 and therefore with respect to the receptacle 2.

[0156] Operating the extrusion device 43 propels the pestle 44 and, the pestle 44 moves the feed plunger 6 in the direction of the cartridge 1. Since the plastic or glass ampoule 3 touches against the connecting plunger 20 on its front side, the internal space of the receptacle 2 decreases in size and the glass ampoule 3 fractures and the monomer liquid 4 exits from the glass ampoule 3 into the internal space of the receptacle 2. The situation is shown in FIG. 3, 2nd figure from the top and in a magnified detail view in FIG. 8. Supernatant air from the receptacle 2 is pushed through the filter 18, the feedthrough 14, the pore filter 16, through the intervening spaces between the particles of the cement powder 5, through the pore filter 36, through the foam 40, and out of the openings in the cap 38 out of the storage and mixing device.

[0157] Lastly, only small fragments 52 of the glass ampoule 3 remain and are retained by the filter 18 and remain in the receptacle 2. The monomer liquid 4 is pressed through the filter 18, the feedthrough 14, and the pore filter 16 into the cement powder 5 and there starts to react with the cement powder 5 such that the bone cement dough 54 is produced from the mixture 54. This situation is shown in FIG. 3, third figure from the top. In addition, the cartridge 1 with the extended dispensing opening is also shown in FIG. 4 and FIG. 5. At this stage, the storage and mixing device is taken out of the extrusion device 43. The receptacle 2 and the housing 32 are unscrewed from the cartridge 1. In addition, the cap 38 with the pore filter 36 and the foam 40 is unscrewed and an extended dispensing opening is screwed onto the dispensing tube 34. Subsequently, the cartridge 1 with the extended dispensing opening is secured again to the extrusion device 43. Earlier, the extrusion device 43 was reset, i.e. the pestle 44 was pushed back again and transitioned into the starting position. After the tube 12 is pulled out, the sealing lips 22 close by their own action such that no monomer liquid 4 still be present in the feedthrough 14 can exit on the rear side of the cartridge 1, when the cartridge 1 is separate from the receptacle 2 (also see the detail view of the detail magnification according to FIG. 9).

[0158] The opposite securing element 48 of the extrusion device 43 engage the securing element 9 on the rear side of the cartridge 1 in order to secure the extrusion device 43 to the cartridge 1. Since the securing element 9 on the cartridge 1 and the securing element 8 on the receptacle 2 are identical, both can be secured to the same opposite securing element 48 of the same extrusion device 43. This simplifies the design and enables the use of conventional extrusion devices 43. In this context, the securing element 8, 9 and the opposite securing element 48 form a bayonet lock.

[0159] The extended dispensing opening comprises a three-way valve 56 that can be operated manually from outside through a T-handle 58. The three-way valve 56 is seated in a tight fit in a tube 59 that forms a valve seat 59. FIGS. 6 and 7 show schematic cross-sectional views as detail views through a valve system that can be used as part of the inventive storage and mixing device according to FIGS. 1 to 5. A collecting container 60, which is closed with respect to the outside and serves for receiving bone cement dough 54, is arranged in the area of the three-way valve 56. A passage 61 forming the inside of the tube 59 is provided in the tube 59. The passage 61 in the front side of the tube 59 can be connected to the receptacle 60 via the three-way valve 56 such that pressurized bone cement dough 54 can evade from the front side of the extended dispensing opening to this location such that no more than a small amount of the bone cement dough 54 continues to flow from the extended dispensing opening, when the three-way valve 56 is in said closed position. As a result, the amount of bone cement dough 54 that continues to flow is reduced through the use of the three-way valve 56. The three-way valve 56 is screwed onto the dispensing tube 34 with the aid of wings 62. The front part of the tube 59 is connected to a hose 64 that merges into a trocar 66.

[0160] The unscrewed rear-side part of the storage and mixing device, namely the receptacle 2 with the fragments 52 in it and the housing 32, stays behind and can be disposed. The front side of the receptacle 2 has a protective tube 68 provided on it, in which the tube 12 is arranged such that the user cannot get injured as easily on the tube 12.

[0161] The bone cement dough 54 can be dispensed through the hose 64 and the trocar 66. For this purpose, the dispensing plunger 7 is propelled in the direction of the dispensing tube 34 by the pestle 44 and the cup 46. When the three-way valve 56 is open, as is shown in FIG. 3 (bottom drawing) and in FIGS. 6 and 7, the bone cement dough 54 is expelled through the dispensing tube 34, through the three-way valve 56 and the passage 61, through the hose 64 and the trocar 66 and can there be applied to the vertebrae of a patient or theoretically be used for further processing. The three-way valve 56 can be operated in order to interrupt the flow of the bone cement dough 54. Pressurized bone cement dough 54 from the hose 64 and the trocar 66 can flow through the three-way valve 56 into the collecting container 60 without contaminating the surroundings. As a result, the flow of the bone cement dough 54 is interrupted rapidly.

[0162] The trocar 66 is connected to the hose 64 through a Luer system adapter 70 (see FIG. 4 or second embodiment from the top on the left in FIG. 5). The trocar 66 can just as well be directly connected to the hose 64. The first embodiment on the top left in FIG. 5 shows a variant, in which a connector 72 connects a Luer system adapter 74 via a short hose 76 to the cartridge 1. The connector 72 can be screwed onto the dispensing tube 34 of the cartridge 1 with the aid of wings 78 in the way of a wing screw. For this purpose, the connector 72 comprises a matching internal thread.

[0163] The detail view of the detail magnification according to FIG. 6 of the valve system additionally shows that the tube 59 is connected to the hose 64 by an insert 80, which comprises a channel that aligns with the passage 61. For this purpose, the insert 80 is screwed into the tube 59. In order to ensure a pressure-tight connection, the hose 64 is crimped onto the insert 80 by a metal sleeve 82, and the tube 59 is sealed with respect to the internal wall of the dispensing tube 34 by two circumferential seals 84. The underside of the three-way valve 56 is secured with a stopper 86 such that the three-way valve 56 cannot be pulled easily from the valve seat 59 or tube 59. A draining channel 88 can be seen in the valve seat 59 in the sectional plane according to FIG. 7, which is perpendicular to the sectional plane according to FIG. 6 and is situated perpendicular to the passage 61, whereby, with the three-way valve 56 being in the closed position, the bone cement dough 54 can flow from the front side of the extended dispensing opening through said draining channel into the collecting container 60.

[0164] FIG. 10 shows a schematic perspective partial view (top) and a schematic partial cross-sectional view (bottom) as detail view of the rear side of the rear part of a storage and mixing device in the starting state. It can be seen that the wall of the receptacle 2 is provided with multiple ventilation openings 90 through which the internal space of the receptacle 2 can be sterilized with the aid of a sterilizing gas such as ethylene oxide. The ventilation openings 90 are arranged immediately adjacent to the feed plunger 6 such that the feed plunger 6 immediately closes the ventilation openings 90 when it is being propelled in the direction of the cartridge 1. This prevents monomer liquid 4 from exiting through the ventilation openings 90, when the glass ampoule 3 in the receptacle 2 was opened.

[0165] FIGS. 11 and 12 each show two schematic perspective cross-sectional views through an exemplary three-way valve 102 for a second alternative storage and mixing device according to the invention, namely the three-way valve 102 in closed position (FIG. 11 top and FIG. 12 bottom) and in open position (FIG. 11 bottom and FIG. 12 top) for illustration of the mode of function of the three-way valve 102 by the internal design.

[0166] The design of the alternative second storage and mixing device according to the invention is the same as that of the preceding first exemplary embodiment according to FIGS. 1 to 10 unless described otherwise or visualized in FIGS. 11 and 12.

[0167] A tube 103 is arranged as extended dispensing opening on the front side of a cartridge (not shown in FIGS. 11 and 12, but provided as in the preceding exemplary embodiment). A hose 104 through which the bone cement dough (not shown in FIGS. 11 and 12) can be dispensed is secured to the valve system downstream of the valve system. To make sure that the bone cement dough cannot exit in uncontrolled manner, a collection container 109 is provided analogous to the embodiment according to FIGS. 6 and 7 and is intended to receive bone cement exiting from the three-way valve 102. As a result, contamination of the surroundingsi.e. in particular of the surgical areaby bone cement dough is prevented. The hose 104 is connected in pressure-tight manner to the valve system by a sleeve 112 made of metal via a crimping connector.

[0168] A static mixer 114 that extends all the way up to the three-way valve 102 is situated in the inside of the tube 103. The static mixer 114 is used to mix the starting components of the bone cement and/or the pre-mixed bone cement dough, when these are pressed through the static mixer 114 in the tube 103.

[0169] The rotatable three-way valve 102 is sectioned in the plane of symmetry of the channels seen therein in the cross-sectional views according to FIGS. 11 and 12. Accordingly, the channels are cylindrical and continue in the cut-off part of the three-way valve 102 in mirror-symmetrical manner. The channels form a T-piece in the three-way valve 102. The three-way valve 102 sits in a fitting valve seat 116 that touches tightly against the three-way valve 102 and thus seals the channels, when these are rotated in the valve seat 116. The valve seat 116 has two passages 119 situated in it by which the larger through-going channel in the three-way valve 102 can be connected in fluid-tight manner to the tube 103 on one side and to an insert 118 made of metal for attachment of the hose 104 on the other side.

[0170] A draining channel 120 connecting the valve seat 116 to the inside of the collecting container 109 that is closed towards the outside is situated perpendicular to the axis of the two passages 119. The valve seat 116 and the tube 103 are provided as a single part made of plastic material. In the open position of the three-way valve 102 (FIG. 11 bottom, FIG. 12 top), the large through-going channel is connected to the two passages 119 and the small perpendicular channel in the three-way valve 102 is closed through the valve seat 116. Accordingly, the bone cement dough from the cartridge can flow from the tube 103 through the three-way valve 102 and the insert 118 into the hose 104. In the closed position of the three-way valve 102 (FIG. 11 top and FIG. 12 bottom), one side of the large through-going channel is connected to the draining channel 120 to the internal space of the collecting container 109 and the smaller perpendicular channel is connected to the passage 119 to the hose 104, whereas the other passage 119 to the tube 103 is closed by the three-way valve 102. Accordingly, the bone cement dough can flow out of the hose 104 and, if applicable, out of a Luer system adapter (not shown) connected to the hose 104 and/or a connected trocar (not shown) into the collecting container 109. The pressure for this purpose results from an elastic deformation of the hose 104 and, if applicable, trocar that has built up during the extrusion and/or while the bone cement dough was pressed through.

[0171] The three-way valve 102 can be rotated manually in the valve seat 116 by a control element (not shown), such as, for example, a T-handle (see the preceding exemplary embodiment). Being cylindrical on the outside, the three-way valve 102 is guided through a cylindrical borehole in the valve seat 116 and is connected to a stopper (not shown in FIGS. 11 and 12, but provided analogous to the preceding exemplary embodiment) on the side opposite from the control element (not shown) and thus is secured against dropping out or against being inadvertently pulled out of the valve seat 116.

[0172] Due to the design according to the invention, it is feasible to rapidly interrupt the flow of bone cement dough by rotating and thus closing the three-way valve 102 without large amounts of the bone cement dough continuing to flow through an application opening (not shown), into which the hose 104 or the trocar merge. Simultaneously, leakage of the bone cement dough and thus contamination of the surroundings or user is prevented by the collecting container 109 that takes up any excess of bone cement dough. Moreover, the pressure in the rear side of the bone cement applicator, i.e. between the three-way valve 102 and the dispensing plunger of the cartridge, is maintained such that the flow of bone cement dough can be provided again rapidly after the three-way valve 102 is opened again without the pressure having to be built up again on the rear side of the storage and mixing device.

[0173] FIGS. 13 and 14 show two schematic cross-sectional views of a third alternative storage and mixing device according to the invention. In this context, FIG. 13 shows a schematic cross-sectional view through the third exemplary embodiment according to the invention and FIG. 14 shows a detail magnification of the connection of the two parts of the third exemplary embodiment according to FIG. 13 before start of the extrusion process as a detail view.

[0174] The design of the third alternative storage and mixing device according to the invention is the same as that of the first exemplary embodiment according to FIGS. 1 to 10 unless described otherwise or visualized in FIGS. 13 and 14.

[0175] The storage and mixing device has, as front part (on the top in FIG. 13 and on the left in FIG. 14), a cartridge 201 made of plastics that has a cylindrical internal space. The cartridge 201 is detachably connected to a receptacle 202 made of plastics for a glass ampoule 203 (or plastic ampoule 203). The receptacle 202 also comprises a cylindrical internal space into which the glass ampoule 203 is plugged. The monomer liquid 204 is situated in the glass ampoule 203. A cement powder 205 is filled or, preferably, pressed into the internal space of the cartridge 201. The monomer liquid 204 and the cement powder 205 are the starting components 204, 205 of a PMMA bone cement that can be produced with the storage and mixing device. Due to the glass ampoule 203, the monomer liquid 204 can be stored in the receptacle 202 and therefore in the storage and mixing device for very long times.

[0176] A feed plunger 206 made of plastics that is mobile in longitudinal direction in the cylindrical internal space of the receptacle 202 is arranged in the receptacle 202. The feed plunger 206 is arranged in the area of the rear side of the receptacle 202. The glass ampoule 203 can be compressed and thereby cracked in the receptacle 202 by the feed plunger 206 by pushing the feed plunger 206 in the direction of the front side, i.e. in the direction of the cartridge 201. The feed plunger 206 comprises, on its front side, wipers by which may assist in wiping fragments of the glass ampoule 203 off the internal wall of the receptacle 202.

[0177] A dispensing plunger 207 made of plastics is arranged in the rear side (toward the bottom in FIG. 13 and toward the right in FIG. 14) of the internal space of the cartridge 201. A securing element 208 is provided on the rear side of the receptacle 202 and can be used to connect the receptacle 202 to an extrusion device (not shown in FIGS. 13 and 14). A securing element 209 of identical design is provided on the rear side of the cartridge 201. Both the receptacle 202 and the cartridge 201 can therefore be secured to the same extrusion device. The securing element 208, 209 are preferably suitable and provided for the formation of a bayonet lock. As a result, the feed plunger 206, which is freely accessible from the rear side of the receptacle 202, can be driven forward in the direction of the front side using the same extrusion device as the dispensing plunger 207, which is freely accessible from the rear side of the cartridge 201, when the cartridge 201 is not connected to the receptacle 202.

[0178] The cartridge 201 and the receptacle 202 are or can be detachably connected to each other via an external thread 210 on the front side of the receptacle 202 and an internal thread 211 on the rear side of the cartridge 201. The receptacle 202 and the cartridge 201 can be connected to each other in liquid-permeable manner with respect to the monomer liquid 204 by a hollow needle 212 made of a metal or a feedthrough 214 in the dispensing plunger 207. The feedthrough 214 through the dispensing plunger 207 merges through a pore filter 216, which is impermeable to the cement powder 205, but permeable to the monomer liquid 204, into the internal space of the cartridge 201. The feedthrough 214 branches into multiple arms before it enters the internal space of the cartridge 201.

[0179] A filter 218, by which the fragments of the glass ampoule 203 can be retained, is arranged in the connection to the hollow needle 212 in the receptacle 202. Instead of the filter 218 or in addition to the filter 218, a screen 218 can be provided just as well or also. The filter 218 is arranged in a connecting plunger 220 that is arranged such as to be mobile in the internal space of the receptacle 202 and has the hollow needle 212 secured to it. In this context, the hollow needle 212 forms the passage through the connecting plunger 220. The connecting plunger 220 is situated at a distance from the front side of the receptacle 202 in this embodiment. In this embodiment, the connection between the internal space of the receptacle 202 and the internal space of the cartridge 201 is generated only upon a motion of the connecting plunger 220.

[0180] During a motion of the connecting plunger 220, the hollow needle 212 punctures an elastic membrane 242 (see FIG. 14). When the hollow needle 212 is pulled out of the membrane 242, the membrane 242 seal the dispensing plunger 207, and thus the cartridge 201, on the rear side in liquid-tight manner. Such membranes 242 are known from containers used for drawing up syringes in the field of medicine.

[0181] The cylindrical connecting plunger 220 has an external circumference that matches the cylindrical geometry of the internal space of the receptacle 202 and is sealed by two circumferential seals 224 in liquid-tight manner with respect to the internal wall of the receptacle 202. Likewise, the feed plunger 206 is sealed in liquid-tight manner with respect to the internal wall of the receptacle 202 by two circumferential seals 226 and the dispensing plunger 207 is sealed in liquid-tight manner with respect to the internal wall of the cartridge 201 by two circumferential seals 228. Moreover, the cartridge 201 and the receptacle 202 are sealed with respect to each other by a seal 230 that is secured to the front surface of the receptacle 202, when the cartridge 201 and the receptacle 202 are secured to each other. The purpose of all of said seals 224, 226, 228, 230 is to prevent monomer liquid 204 or bone cement from exiting in order to prevent contamination of the surroundings (the OR theatre and the user). For this purpose, the seals 224, 226, 228, 230 can consist of rubber.

[0182] In addition, the receptacle 202 is surrounded by a housing 232 made of plastics, whereby the housing 232 is connected to the receptacle 202 and covers, on the front side, the securing element 209 of the cartridge 201, when the cartridge 201 is connected to the receptacle 202. The cartridge 201, the receptacle 202, and the housing 232 can be produced through injection molding.

[0183] The front side of the cartridge 201 merges into a dispensing tube 234 that comprises an external thread. A pore filter 236 that is impermeable to the cement powder 205, but is permeable to gases is arranged in the inside of the dispensing tube 234. A cap 238 is secured to the external thread of the dispensing tube 234, whereby the front part of the cap 238 is filled with a Styrofoam or foam 240. The cap 238 can be unscrewed from the dispensing tube 234. The cap 238 comprises lateral openings. Due to this design, the inside of the cartridge 201 and the cement powder 205 can be sterilized with the aid of ethylene oxide, since the openings in the cap 238, the Styrofoam or foam 240, the pore filter 236, and the intervening spaces between the powder particles of the cement powder 205 are permeable to air. Concurrently, air can be pressed out of the receptacle through the cement powder 205, the pore filter 236, the Styrofoam or foam 240, and the openings in the cap 238, when the feed plunger 206 is pressed in the direction of the receptacle 201.

[0184] The cement powder 205 is enclosed in the cartridge 201, since all openings are closed by the pore filters 216, 236 such as to be impermeable to the cement powder 205. The content of the cartridge 201 can be sterilized by evacuation and rinsing with ethylene oxide in this context. As a result, the storage and mixing device is also well-suited for long-term storage of the cement powder 205.

[0185] The workflow of a method according to the invention is discussed in the following on the basis of the third exemplary embodiment. At the outset of the method, the storage and mixing device is in the starting state that is also shown in FIGS. 13 and 14. Accordingly, the cartridge 201 and the receptacle 202 of the storage and mixing device are initially connected to each other through the threads 210, 211. Being in this state, the storage and mixing device is inserted into an extrusion device in the form of a conventional cartridge gun and is secured to the extrusion device using the securing element 208.

[0186] The extrusion device comprises a pestle that can be propelled linearly and is designed analogous to the extrusion device 43 according to FIGS. 1 to 10. The extrusion device 43 is connected to the rear side of the receptacle 202 through an opposite securing element such that the pestle pushes onto the feed plunger 206 and propels it in the direction of the cartridge 201, when the pestle is propelled forward. For this purpose, the pestle is supported such as to be linearly mobile with respect to the opposite securing element and therefore with respect to the receptacle 202.

[0187] Operating the extrusion device propels the pestle and, the pestle propels the feed plunger 206 in the direction of the cartridge 201. Since the glass ampoule 203 or plastic ampoule 203 touches against the front side on the connecting plunger 220, the connecting plunger 220 is pushed in the direction of the cartridge 201. The hollow needle 212 punctures the membrane 242 and a plug 222. The purpose of the plug 222 is to stabilize the hollow needle 212. This establishes a liquid-conducting connection between the internal space of the cartridge 201 and the internal space of the receptacle 202. Due to the motion of the feed plunger 206, the feed plunger 206 closes ventilation openings (not shown) that are arranged in the wall of the receptacle 202 in the area of the feed plunger 206 and allow the internal space of the receptacle 202 to be evacuated and sterilized with ethylene oxide in the starting state. The connecting plunger 220 is pushed against the front side of the internal space of the receptacle 202 and cannot be moved any further. As a result, the internal space of the receptacle 202 decreases in size when the feed plunger 206 is propelled further, and the glass ampoule 203 fractures and the monomer liquid 204 exits from the glass ampoule 203 into the internal space of the receptacle 202. Supernatant air from the receptacle 202 is pushed through the filter 218, the feedthrough 214, the pore filter 216, through the intervening spaces of the cement powder 205, through the pore filter 236, through the foam 240, and out of the openings in the cap 238 out of the storage and mixing device.

[0188] Lastly, only small fragments of the glass ampoule 203 remain and are retained by the filter 218 and remain in the receptacle 202. The monomer liquid 204 is pressed through the filter 218, the feedthrough 214, and the pore filter 216 into the cement powder 205 and there starts to react with the cement powder 205 such that the bone cement dough is produced from the mixture. At this stage, the storage and mixing device is taken out of the extrusion device. The receptacle 202 and the housing 232 are unscrewed from the cartridge 201. In addition, the cap 238 with the pore filter 238 and the foam 240 is unscrewed and an extended dispensing opening is screwed onto the dispensing tube 234. Subsequently, the cartridge 201 with the extended dispensing opening is secured again to the extrusion device. Earlier, the extrusion device was reset, i.e. the pestle was pushed back again and transitioned into the starting position. After the hollow needle 212 is pulled out, the membrane 242 closes by its own action such that no monomer liquid 204 still present in the feedthrough 214 can exit on the rear side of the cartridge 201, when the cartridge 201 is separate from the receptacle 202.

[0189] To secure the extrusion device to the cartridge 201, the opposite securing element of the extrusion device engage the securing element 209 on the rear side of the cartridge 201, which were also used for securing to the securing element 208 of the receptacle 202. Since the securing element 209 on the cartridge 201 and the securing element 208 on the receptacle 202 are identical, both can be secured to the same opposite securing element of the same extrusion device. This simplifies the design and enables the use of conventional extrusion devices. In this context, the securing element 208, 209 and the opposite securing element preferably form a bayonet lock.

[0190] The extended dispensing opening can preferably comprise a three-way valve analogous to the first or second embodiment. Likewise, a hose and/or a trocar can be connected to the dispensing tube 234.

[0191] The unscrewed rear-side part of the storage and mixing device, namely the receptacle 202 with the fragments 203 of the glass ampoule 203 in it and the housing 232, can be disposed of once they are unscrewed. The front side of the receptacle has a protective tube 268 provided on it, in which the hollow needle 212 is arranged such that the user cannot get injured as easily on the hollow needle 212.

[0192] The bone cement dough can be dispensed through the hose and the trocar or through the dispensing tube 234. For this purpose, the dispensing plunger 207 is propelled in the direction of the dispensing tube 234 by the pestle. The bone cement dough from the inside of the cartridge 201 is expelled either directly through the dispensing tube 234 or, if the three-way valve is open, through the dispensing tube 234, through the three-way valve, through the hose, and the trocar and can there be applied to the vertebrae of a patient or theoretically be used for further processing. The three-way valve can be operated, if applicable, in order to interrupt the flow of the bone cement dough.

[0193] The features of the invention disclosed in the preceding description and in the claims, figures, and exemplary embodiments, can be essential for the implementation of the various embodiments of the invention both alone and in any combination.

[0194] Although illustrated and described above with reference to certain specific embodiments, the present invention is nevertheless not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the spirit of the invention. It is expressly intended, for example, that all ranges broadly recited in this document include within their scope all narrower ranges which fall within the broader ranges.