MIXING AND DISPENSING SYSTEM AND METHOD OF MIXING AND DISPENSING MATERIAL FROM A MIXING AND DISPENSING SYSTEM

A mixing and dispensing system for a two-component material, such as a bone cement, the mixing and dispensing system including a handle connected to the mixer via a mixing shaft. The mixing shaft extends through the piston from the piston driving end in the direction of the outlet end in order to move the mixer in dependence on movements initiated via the handle, and with the handle being detachable, in particular in a non-destructive manner, from the mixing shaft via a connector.

CROSS-REFERENCE RELATED APPLICATION

This application claims priority to European Patent Application No. 19206082.0, filed Oct. 30, 2019, the contents of which are hereby incorporated herein by reference in their entirety.

BACKGROUND

Field of the Invention

The present invention relates to a mixing and dispensing system for a two-component material, such as a bone cement, the mixing and dispensing system comprising a handle connected to the mixer via a mixing shaft, wherein the mixing shaft extends through the piston from the piston driving end in the direction of the outlet end in order to move the mixer in dependence on movements initiated via the handle, and with the handle being detachable, in particular in a non-destructive manner, from the mixing shaft via a connector. The invention further relates to a method of mixing and dispensing material from a mixing and dispensing system.

Background Information

Mixing and dispensing systems are known to mix two-component materials, such as the ones used in joint replacement surgery. On mixing two-component material, such as cement, e.g. PMMA (poly-methyl methacrylate) used e.g. in joint replacement surgery, such as hip replacement surgery, cracks in the cement mantle may facilitate a mechanical loosening of the prosthesis.

Moreover, the cement is to be used in a sterile environment and may be rather harmful to the user of the mixing and dispensing system which is why the possible contact of the user with the cement prepared in the mixing and dispensing system is not desirable.

SUMMARY

For this reason it is an object of the invention to provide a mixing and dispensing system in which the two-component material can be sufficiently mixed, such that no fatigue cracks occur in the solidified two-component material and in which the contact a user of the mixing and dispensing system may have with the two-component material to be mixed can be minimized.

This object is satisfied by a mixing and dispensing system described herein.

Such a mixing and dispensing system for a two-component material, such as a bone cement, comprises a cartridge having a piston driving end and an outlet end and a chamber formed therebetween for storage of at least a first component of the two-component material, a piston arranged moveable to and fro between the piston driving end and the outlet end and stored initially at the piston driving end, a mixer arranged within the chamber between the piston and the outlet end, wherein the mixer is moveable relative to the piston and the chamber and a handle connected to the mixer via a mixing shaft, wherein the mixing shaft extends through the piston from the piston driving end in the direction of the outlet end in order to move the mixer in dependence on movements initiated via the handle, and with the handle being detachable, in particular in a non-destructive manner, from the mixing shaft via a connector.

The mixer is provided with the cartridge in order to mix the two-component material within the cartridge to achieve the desired mixing results and to avoid the provision of further components that would require increased cost of manufacture and would further be required to be produced in a sterile environment.

The handle can initiate both rotational and translational movements of the mixer in order to thoroughly mix the two-component materials. Following the mixing the handle can then be removed in a non-destructive and/or tool-free manner via the connector.

In this way a pre-loaded and sterile cartridge of the mixing and dispensing system can be made available which is particularly useful in a medical environment of use. Moreover, since the handle can be removed by way of a connector, there is no danger of a user of the mixing and dispensing system coming into contact with the mixed two-component material.

The handle may comprise a rod and the rod is detachable from the mixing shaft via said connector. Such rods can easily be inserted into mixing shafts and may have an outer shape complementary to an inner shape of the mixing shaft which at least in regions is non-symmetrical in order to transmit both rotational and translational forces from the rod to the mixing shaft.

The connector may be part of a drive interface for applying translational as well as rotational forces at the mixer via said rod and mixing shaft, such as a drive interface formed by a tight fit respectively a force fit. In this way both translational as well as rotational forces can be transmitted from the handle to the mixer.

The rod may comprise elements more flexible than the mixing shaft at the connector. Such elements can be used to disconnect the rod from the mixing shaft in a simple manner.

The connector may comprise one or more buttons that can be depressed to disengage the handle from the mixing shaft. The provision of such buttons makes available well defined points of activation of the connector for detaching the rod respectively the handle from the mixing shaft.

The one or more buttons may be connected to the elements more flexible than the mixing shaft. In this way the elements which have to be actuated to disconnect the rod from the mixing shaft are in direct connection with the buttons which initiate the disconnection of the rod from the mixing shaft.

The connector, i.e. the buttons thereof, may be arranged outside of the cartridge. In this way the access to the connector can be achieved in a simple manner.

The rod may extend from the handle beyond the connector towards the mixer within said mixing shaft. In this way a stable connection between the rod and the mixing shaft in the region of the connector can be achieved.

By way of example between 10 and 50%, in particular 15 to 40% of a length of the rod may project beyond the connector into the mixing shaft in order to facilitate a stable connection between the rod and the mixing shaft.

The handle may be arranged at least substantially perpendicular to the mixing shaft. In this way a user can beneficially grip the handle relative to the mixing shaft in order to initiate both rotational and translation movements of the mixer.

The mixing shaft may be journaled by said piston. This means that the mixing shaft may pass through the piston between the handle and the mixer. This facilitates a smaller construction of the cartridge which produces less waste material on producing and using such cartridges.

The rod may be journaled by said mixing shaft. This means that the rod is received within the mixing shaft rather than the mixing shaft being received within the rod.

The mixer may be moveable axially along a longitudinal axis between the piston and the outlet end and is rotatable about the longitudinal axis. In this way beneficial mixing results of the two-component material to be mixed can be achieved as rotational as well as translational movements of the mixer can be carried out in the cartridge.

The piston may be releasably locked in a storage position at the piston driving end prior to mixing with said mixer; and the piston may be moveable via a dispensing mechanism, such as a threaded dispenser, following the release of the piston from the storage position for dispensing said two-component material from said cartridge. In this way a construction space of the cartridge can be further reduced reducing the waste material following use of the mixing and dispensing system, since the piston is stored in the cartridge. Moreover, through the use of a dispensing mechanism, the two-component material can be dispensed in an expedient and accurate manner.

The mixer may comprise two or more vanes extending radially outward from the mixing shaft. Such vanes enable an improved mixing of the two-component material in the cartridge.

The mixer may comprise two or more vanes extending radially outward from the mixing shaft, said two or more vanes may be connected to an outer ring. The provision of an outer ring can stabilize the mixer and hence lead to improved mixing results in comparison to mixers without such outer rings.

The outlet end may comprise a first interface via which an ampoule container and a dispensing outlet can be releasably connected to the cartridge. The piston driving end may comprise a second interface via which a dispensing mechanism can be connected to the cartridge after the handle has been removed from the mixing shaft. The provision of such first and second interfaces ensures a reliable and quick exchange of the respective components at the mixing and dispensing system, which particularly in a surgical environment where the medical professionals use gloves etc. can be particularly beneficial.

According to a further aspect the present invention relates to a method of mixing and dispensing material from a mixing and dispensing system, the method comprising the steps of:moving the mixer in dependence on movements initiated via the handle, and detaching the handle from the mixing shaft via a connector.

By way of such a method the handle can be reliably removed from the mixing and dispensing system while the user does not come into contact with the mixed two-component material, such that pre-loaded and sterile mixed two-component materials can be made available in a sterile cartridge which is particularly useful in a medical environment of use.

DETAILED DESCRIPTION

In the following the same reference numerals will be used for parts having the same or equivalent function. Any statements made having regard to the direction of a component are made relative to the position shown in the drawing and can naturally vary in the actual position of application.

FIG. 1Ashows a side view of components of a mixing and dispensing system10for mixing a two-component material M′, M″, such as a bone cement.FIG. 1Bshows a sectional view taken along the sectional line B:B ofFIG. 1Aof the mixing and dispensing system10.

The mixing and dispensing system10comprises a cartridge12for storage of a first component M′ of the two-component material M′, M″, the cartridge12comprising a mixer14arranged therein.

An ampoule container16for receiving an ampoule18comprising a second component M″ of the two-component material M′, M″ is connected to the cartridge12via a first interface20. The first interface20is configured to releasably connect and disconnect the cartridge12with and from said ampoule container16. A longitudinal axis A extends between said cartridge12and said ampoule container16and through said first interface20.

The ampoule container16further comprises an activation element24. On moving said activation element24from a storage position into an activated position, a part26of said activation element24moves perpendicular to said longitudinal axis A such that the part26contacts a top32of said ampoule18for opening said ampoule18when said activation element24is displaced from the storage position into the activated position. Thereby the second component M″ stored in said ampoule18can be released from said ampoule18into said cartridge12to come into contact with said first component M′ stored in said cartridge12for mixing the two-component material M′, M″ in said cartridge12with said mixer14.

The activation element24is arranged partly at an outer wall28of the ampoule container16. More specifically a rotatable switch30, such as a half turn coupling30′, of the activation element24is arranged at the outer wall28. The activation element24further comprises an activation plunger26′ arranged within said ampoule container16. The activation plunger26′ is configured to contact the top32of said ampoule18for opening said ampoule18when said activation element24is displaced from the storage position into the activated position.

In this connection also a quarter turn coupling or the like would be feasible to activate the activation plunger26′.

In order to displace the activation plunger26′ from the storage position into the activated position, the rotatable switch30is rotated about an axis of rotation R to produce an axial movement of said activation plunger26′ along said axis of rotation R of said rotatable switch30.

A vacuum port22is also arranged at the ampoule container16for providing a vacuum within the mixing and dispensing system10. The vacuum port22is arranged remote from the activation element24in such a way that it does not come into contact with the rotatable switch30on rotating the rotatable switch30about the axis of rotation R.

On mixing two-component material M′, M″, such as cement M, M″, e.g. PMMA (poly-methyl methacrylate) used e.g. in joint replacement surgery, such as hip replacement surgery, cracks in the cement mantle may facilitate a mechanical loosening of the prosthesis. In order to avoid this a vacuum is applied on mixing the cement M′, M″ in the cartridge12to reduce the cement porosity of the cement such that less cracks, pores etc. are formed in the cement and particularly its mantle.

In this connection it should be noted that the cartridge12should be sealed off to the outside during the mixing of the two-component material M′, M″, such that a contamination or the like of the two-component material M′, M″ can be avoided.

For this purpose the vacuum port22is arranged at the outer wall28of the ampoule container16such that it can evacuate a chamber50of the cartridge12formed between a piston driving end46and an outlet end48of the cartridge12.

In order to evacuate the chamber50, a groove96, in particular an L-shaped groove96, leads from the vacuum port22to the chamber50through the first interface20to the cartridge12. The vacuum port22can be connected to a source of vacuum (not shown) via a vacuum line98in a manner known per se.

In this connection it should be noted that a corresponding passage or groove can also be provided extending from the vacuum port22to the chamber50if the vacuum port22is arranged at the cartridge12rather than at the ampoule container16.

It should further be noted in this connection that it is preferred to have the vacuum port22at the ampoule container16since this makes the handling of the cartridge12simpler after mixing and disconnecting of the ampoule container16, since no vacuum port22would then be present at the cartridge12.

The mixer14is also arranged within the chamber50between the piston34and the outlet end48, with the mixer14being moveable relative to the piston34and the chamber50during mixing of the cement M′, M″. The mixer14can be moved radially about said longitudinal axis A and axially along said longitudinal axis A for mixing said two-component material M′, M″.

A piston34is arranged moveable to and fro between the piston driving end46and the outlet end48of the cartridge and is stored initially at the piston driving end46. The piston34is pre-positioned within the cartridge12such that once a force above a threshold pressure is applied on the piston34, the piston34can dispense the mixed two-component material M′, M″ from the cartridge. Such forces can typically be selected in the range of 100 to 3000 N.

The piston34may be moveable via a threaded dispenser40(seeFIG. 4A) following the release of the piston34from the storage position for dispensing said two-component material M′, M″ from said cartridge12.

Once the ampoule18has been opened the second component M″ stored therein is moved into the cartridge12via a passage100arranged at the ampoule container16for mixing in the chamber50.

In order to avoid glass splinters (not shown) from being moved together with the second component M″ into the cartridge12, a net102is arranged around the top32of the ampoule18.

A cap106can be placed onto the end104of the ampoule container16remote from the end108present at the first interface20. The cap106can act as a stand for the ampoule container16, such that on storing and/or activating the mixing and dispensing system10, the mixing and dispensing system10can stand on a surface via this cap106.

A part36, more specifically a rod36′, of the mixer14is detachable via a connector38of a drive interface38′, in such a way that the threaded dispenser40of a dispensing mechanism40′ (seeFIG. 4A) can be connected to the mixing and dispensing system10via a second interface42of the cartridge12at the piston driving end46.

The mixer14is connected to a handle52via a mixing shaft54and the rod36′. The mixing shaft54extends between the handle52and the mixer14and passes through the piston34via a piston passage56such that the mixer14can be moved in dependence on movements initiated via the handle52and indeed relative to the piston34and the chamber50.

The handle52is detachable, in particular in a non-destructive manner, from the mixing shaft54via the connector38. In this connection it should be noted that the handle52can also be removed without the use of tools, i.e. in a tool-free manner.

On storing the mixing and dispensing system10, the handle52and part of the mixing shaft54are stored in a stand110that comprises respective grooves112,114for receiving and storing the handle52and part of the mixing shaft54. An end118of the stand is arranged adjacent to the piston driving end46in the storage state of the mixing and dispensing system10. As indicated inFIG. 1B, the stand110may comprise a support116to reinforce the stand110and to ensure the handle52and thus the mixer14is not moved in the storage state of the mixing and dispensing system10.

In this connection it should be noted that the precise position of the mixer14within the cartridge12is not pre-defined in the storage state of the mixing and dispensing system10, the stand110should merely ensure that the mixer14does not move in the storage state of the mixing and dispensing system10.

FIG. 2Ashows an enlarged view of the first interface20and of the activation element24ofFIG. 1A. The first interface20is formed by a bayonet type interface in order to releasably couple the ampoule container16to the cartridge12. As indicated inFIG. 4Aalso a dispensing outlet44can be releasably coupled to the cartridge12via the first interface20.

To form the first interface20an outer surface120of the cartridge12comprises pins122extending radially therefrom. The pins122engage matching slots124(see alsoFIG. 2B) present in a cap126of the first interface20. InFIG. 2Aapertures128of the slots124are visible. In this connection it should be noted that between 2 and 6, preferably between 2 and 4 pins122with matching slots124can be provided. The cap126in this way sits on the outlet end48of the cartridge12.

A distance between the cap126and the activation element24shown is such that the switch30can be rotated by at most approximately 270° relative to the ampoule container16. This means that a distance the activation plunger26′ can travel between the storage position and the activation position has to be achieved by at most a 270° degree turn of the rotatable switch30, with the illustrated design of the rotatable switch30.

If more turns are desired then a distance between the cap126and the rotatable switch30has to be increased, such that these components do not interfere with one another.

Additionally or alternatively, the activation element24could be snap fit into place and the rotation thereof can be used solely for displacing the activation plunger26′ along the axis of rotation R.

In the present instance, it has been found to be prudent to use a half turn coupling as the rotatable switch30as in this way one achieves a maximum distance the plunger26′ can travel in a well-defined manner through a minimum rotation of the rotatable switch30to achieve the opening of an ampoule18stored in the ampoule container16.

FIG. 2Bshows an enlarged view of the section through the first interface20and the activation element24ofFIG. 1B. A membrane130is visible between the top32of the ampoule and the cap126. This membrane130aids in preventing glass splinters from arriving in the cartridge12.

As is further evident in the sectional drawing indicated inFIG. 2B, the plunger26′ is arranged at the rotatable switch30. To bring about the rotation of the rotatable switch30, this comprises an inner thread132, which can rotate on an outer thread134of a hollow projection136projecting radially outwardly from an outer surface138of the ampoule container16.

The plunger26′ projects from within the rotatable switch30through the outer wall28of the ampoule container16via the hollow projection136, so that a tip26″ of the plunger26′ can contact the top32of the ampoule18above a neck140of the ampoule18in order to break and/or open the ampoule18.

For the purpose of breaking and/or opening the top32of the ampoule, the tip26″ may have a specific shape, such as the frustoconical shape shown inFIG. 2B, or also have a conical shape or have a rounded shape.

In this connection it should be noted that the rotatable switch30may be integrally formed together with the plunger26′ having the tip26″ as one piece in an injection molding process.

The specific design of the mixer14is also shown inFIG. 2B. The mixer14is moveable axially along the longitudinal axis A between the piston34and the outlet end48and is rotatable about the longitudinal axis A. In order to carry out the mixing the mixer comprises several vanes62extending radially outward from the mixing shaft54. At their radial outer ends the vanes62are connected to an outer ring64. By way of this mixer14design the two-component material M′, M″ can be thoroughly mixed. Also other designs of mixers14are possible (not shown).

FIG. 3Ashows an enlarged sectional view of the handle52of the mixing and dispensing system10shown inFIG. 1B. The mixing shaft54extends between the handle52and the mixer14through the piston34via the piston passage56and into the cartridge12. The mixing shaft54is journaled by said piston34in the piston passage56.

To connect the handle52to the mixing shaft54, a rod36′ that is non-releasably connected to the handle52projects into said mixing shaft54and is thereby journaled by said mixing shaft54. The rod36′ extends from the handle52beyond the connector38towards the mixer14within said mixing shaft54.

In order to release the handle52from the mixing shaft54, the connector38has to be arranged outside of the cartridge12for actuation thereof. On releasing the handle52two buttons60have to be depressed to disengage the handle52from the mixing shaft54.

This is possible in the present example, since the rod36′ comprises elements58more flexible than the mixing shaft54at the connector38. On pressing the buttons60, the buttons66press the elements58such that they deflect inwardly so that the rod26′ of the handle can disengage from the mixing shaft54.

This is made possible, since the elements58are able to deflect relative to the mixing shaft54and hence are more flexible than the mixing shaft54, due to less material being provided and the elements58therefore being less rigid than the mixing shaft54.

Also other methods of releasably and non-destructively releasing the handle52from the mixing shaft are possible, for example using threaded components (not shown).

Part of the second interface42is also indicated inFIG. 3A, where an inner thread142is present at an inner surface80of a cartridge wall90of the cartridge12, via which second interface42the threaded dispenser40(seeFIG. 4A) can be releasably coupled to the cartridge12.

FIG. 3Bshows an enlarged side view of the handle ofFIG. 3A. The handle52is formed by a bar144in this example, but also other shapes are possible, such as a knob or the like. The bar144of the handle52is arranged perpendicular to the mixing shaft54.

FIG. 3Cshows an exploded view of the handle52ofFIG. 3Bpartly removed from a mixing shaft54. The connector38is part of a drive interface38′ for applying translational as well as rotational forces initiated via said handle52at the mixer14specifically via said rod36′ and mixing shaft54.

For this purpose and as indicated inFIG. 3Can end146of the rod36connected to the handle52may comprise a hexagonal fitting148. The hexagonal fitting148engages a hexagonal shaped socket150formed in the mixing shaft54. In this way both translational and rotational forces can be transmitted from the handle52to the mixer14via this tight fit respectively force fit detachable connection. In this connection it should be noted that also other kinds of detachable connections are possible provided they permit a transmission of rotational and translational forces from the handle52to the mixer14.

FIG. 4Ashows a sectional view similar to the one ofFIG. 1Bwith the threaded dispenser40, i.e. a dispensing mechanism40′, arranged at the piston driving end46and the dispensing outlet44arranged at the outlet end48of the cartridge12of the mixing and dispensing system10.

The dispensing outlet44is releasably connectable to said cartridge12via said first interface20on removal of said ampoule container16(seeFIGS. 1A to 2B). The dispensing outlet44shown has an inlet43at its end adjacent the first interface20and an outlet45at its opposite end, with an inner diameter of the dispensing outlet44tapering from the inlet43towards the outlet45, such that the outlet45has a smaller diameter than the inlet43. The dispensing outlet44thus has a frustoconical shape. In this connection it should be noted that also other shapes of dispensing outlets44can be provided (not shown).

The dispensing mechanism40′ comprises a sleeve66having a first thread68arranged at an outer surface70thereof for connecting the sleeve66to the piston driving end46of the cartridge12. The dispensing mechanism40′ further comprises a cartridge plunger72that can be arranged partly within said sleeve66, the cartridge plunger72being moveable with and relative to said sleeve66, and the cartridge plunger72having a second thread74arranged at an outer surface76thereof. The second thread74can interact with an inner thread78present at an inner surface80of the sleeve66. The cartridge plunger72comprises an engagement part82for rotating at least the cartridge plunger72and depending on the state of use of the threaded dispenser40′ also the sleeve66.

FIG. 4Bshows a part sectional part schematic view of the threaded dispenser40ofFIG. 4A. First and second holding members84,86are present between the cartridge plunger72and the sleeve66. The first and second holding members84,86are configured to hold the cartridge plunger72at the sleeve66when a torque below a pre-defined threshold is applied at the cartridge plunger72in a manner similar to a torque wrench. Moreover, the first and second holding members84,86are configured to release the cartridge plunger72from the sleeve66once a torque above a pre-defined threshold is applied at the cartridge plunger72.

In this connection it should be noted that the pre-defined threshold can be selected in the range of 0.2 to 1.2 Nm.

The first holding member84is formed at an outer surface76of the cartridge plunger72and comprises a plurality of teeth84′. The second holding member86is formed at the inner surface80of the sleeve66and comprises a plurality of cams86′. The plurality of teeth84′ and the plurality of cams86′ are formed complementary to one another.

The plurality of teeth84′ are configured to slip over the plurality of cams86′ when a torque applied at said cartridge plunger72exceeds the pre-defined threshold, in a manner similar to a slipper type torque wrench.

The engagement part82is formed as a handle in the embodiment shown. As the case may be the engagement part82may comprise a coupling point152such as a hexagonal socket for connecting the dispensing mechanism40′, i.e. the threaded dispenser40to a further component, such as a power tool or a hand tool for rotating the cartridge plunger72.

FIG. 4Cshows an enlarged view of the section shown inFIG. 4Ain the region of the piston driving end46of the cartridge12. The first thread68is configured to engage the inner surface88of the cartridge wall90of the cartridge12.

On moving the sleeve66into the cartridge12it is configured to release the piston34present in said cartridge12from a storage position of said piston34. Once the sleeve66has arrived at its final position in the cartridge12, the cartridge plunger72experiences a resistance so that the torque required to turn the cartridge plunger72further in the direction of the longitudinal axis A exceeds the pre-defined threshold, whereby the cartridge plunger72disengages from the sleeve66at the first and second holding members84,86and slips out of engagement from the sleeve66.

Then the second thread74starts to turn relative to the sleeve66in the inner thread78present at the inner surface80of the sleeve66. This moves the cartridge plunger72further along the longitudinal axis A into the cartridge12. The cartridge plunger72is configured to move the piston34present in said cartridge12to and fro along the longitudinal axis A of said cartridge12once the sleeve66has released the piston34from the storage position of said piston.

On releasing the handle52from the mixing shaft54, neither the mixer14nor the mixing shaft54are removed, the threaded dispenser40is moved over the mixing shaft54, which is received in a passage92configured for receiving the mixing shaft54.

FIG. 4Dshows a part sectional part schematic view of the first and second threads68,74of the threaded dispenser40ofFIG. 4A. The first and second threads68,74have different pitches, with the second thread74being finer than the first thread68, i.e. the second thread74has a lower thread pitch than the first thread68.

FIG. 4Eshows an enlarged partial view of part of the threaded dispenser40ofFIG. 4A. The sleeve66has an abutment94at an end thereof remote to the end that is initially introduced into the cartridge12. The abutment94comes into contact with the piston driving end46of the cartridge12once the sleeve66has arrived at its final position in the cartridge12. This is typically the position in which the torque on the cartridge plunger72can reach the pre-defined threshold in order to disengage the cartridge plunger72from the sleeve66.

FIG. 4Fshows a sectional view taken along the section A:A ofFIG. 4E. In this drawing like inFIG. 4Eone can see that the abutment94is arranged at the same axial height as the second holding member86which in turn may be formed by the plurality of cams86′ within the sleeve66.

FIG. 4Gshows an enlarged view of part of the section ofFIG. 4F. In this view both the plurality of cams86′ as well as the plurality of teeth84′ respectively forming the second and first holding members86,84are visible. If a torque less than a pre-defined threshold is applied at the plunger then the teeth84′ mesh with the cams86′ to rotate the sleeve66. If a torque exceeding the pre-defined threshold is applied, then the teeth84′ slip over the cams86′ so that the cartridge plunger72can move relative to the sleeve66.

On activating the mixing and dispensing system10illustrated inFIGS. 1A and 1B, the activation element24is moved from the storage position into the activated position, thereby the part26, i.e. the activation plunger26′, of said activation element24is moved perpendicular to said longitudinal axis A and comes into contact with the top32of the ampoule18to open this and to release the second component M″ stored therein. The second component M″ is brought into contact with the first component M′ in said cartridge12. The first and second components M′, M″ of the two-component material M′, M″ are then mixed in the chamber50of the cartridge12with said mixer14.

To mix the two-component material M′, M″, the mixer is moved via the mixing shaft54and handle52to and fro along the longitudinal axis A and by rotating the handle52, the mixer is also rotated about the longitudinal axis A. The vanes62and the outer ring64bring about a thorough through mixing of the two-component material M′, M″, as the mixer is moved through the chamber50and through the two-component material M′, M″.

It should be noted that the handle52and/or the mixing shaft54may have a socket, such as the hexagonal socket150, via which the mixer14and the mixing shaft54can be set into rotation using e.g. a power tool. In this way more uniform mixing results of the two-component material M′, M″ can possibly be achieved.

In this connection it should be noted that the vacuum applied via the vacuum port22can be applied either before or during opening of the ampoule18. If the vacuum is applied before breaking of the ampoule18, this has the advantage that movement of the second component M″ stored in the ampoule18into the cartridge12can be assisted through the use of the vacuum as soon as the ampoule18is open as the vacuum so to say sucks the second component M″ into the cartridge12.

Moreover, due to the presence of the vacuum the amount of air and thus pores in the mixed two-component material M′, M″ is significantly reduced, so that less air is present in the mixture reducing the amount of fatigue cracks that may appear in the solidified two-component material M′, M″, leading to improved adhesion results between the two-component material M′, M″ and the surfaces (not shown) between which it is applied.

Following the mixing of the two-component material M′, M″ with the mixing and dispensing system10the handle52connected to the mixer14via the mixing shaft54is detached. For this purpose a user presses the buttons60present at the connector38. By pressing the buttons60the elements58more flexible than the mixing shaft54present at the rod36′ allow the rod36′ to disengage from the mixing shaft54in the regions of the apertures55present in the mixing shaft54, whereby the rod36′ can be removed from the mixing shaft54to detach the handle52from the mixing shaft54via the connector38.

In order to dispense material from the mixing and dispensing system10the user has to remove the ampoule container16from the cartridge12via the first interface20. Following which the user can arrange a dispensing outlet44, such as the dispensing outlet44shown inFIG. 4A, at the cartridge12using the first interface20.

Following this the user now has several options to press the mixed two-component material M′, M″ out of the chamber50of the cartridge12. One option is to install an insert (not shown) at the second interface42, via which a dispensing gun can be connected to the cartridge12, for dispensing the two-component material M′, M″ from the cartridge12.

The other option is to use the dispensing mechanism40′ discussed in relation toFIGS. 4A to 4G. This is done by attaching the sleeve66at the second interface42, by turning the cartridge plunger72, such that the first thread68of the sleeve66is turned into the inner thread142. During the connection of the sleeve66to the cartridge the force on the sleeve66is below a pre-defined threshold value such that the sleeve66is entrained by the first and second holding members84,86and transmits the rotations of the cartridge plunger72onto the sleeve66. Once the abutment94contacts the cartridge12, the sleeve66is finally installed at the second interface42. As the sleeve66reaches its final position it also releases the piston34from the storage position for dispensing said two-component material M′, M″ from said cartridge12.

In this final position the sleeve66experiences a resistance at the cartridge which means that an increased force has to be applied at the cartridge plunger72in order to rotate this further. This means that a force above the pre-defined threshold value is applied at the cartridge plunger72, such that the first holding members84slip past the second holding members86so that the second thread74present at the outer surface outer surface76of the plunger can interact with the inner thread78present at an inner surface80of the sleeve66.

The cartridge plunger72then comes into contact with the piston34for dispensing said two-component material M′, M″ from said cartridge12. Once the cartridge plunger72has slipped past the first and second holding members84,86one rotates only the cartridge plunger72via the engagement part82. The engagement part82can be rotated either by hand or using a power tool (not shown) connectable to the engagement part via the coupling point152.

On moving the piston34via the cartridge plunger72, the mixer14may at least at some point of the dispensing process rest on the piston34and be entrained via the piston34.

The dispensing mechanism40′ is designed in a way that allows a fast forwarding at the beginning, i.e. while the sleeve66is attached to the cartridge12via the second interface42, and once the torque above a pre-defined threshold is achieved changes over to the cartridge plunger72having a lower pitch which transmits higher forces when needed for dispensing the two-component material M′, M″ via the dispensing outlet44.

In this connection it should be noted that a material of at least one of the cartridge12, the ampoule container16, the cap126of the first interface20, the cap106and the stand110and of the piston34may be polypropylene (PP).

A material of at least one of the handle52, the rotatable switch30, the rod36′, and the threaded dispenser40may be one of PP and polyamide (PA).

The net102and of the membrane130may be formed of a thermoplastic elastomer (TPE).

Using the above mixing and dispensing system10a user, such as a medical professional, can minimize exposure to the two-component material M′, M″. If, for example PMMA is used as a Monomer then this Monomer can be disturbing for the respiratory tract. The use of the ampoule container described in the foregoing, the disconnectable handle and the dispensing mechanism40′ reduces the risk of the medical professional coming into contact with the monomer. Moreover, if the dispensing mechanism40′ is used one can use the mixing and dispensing system10independent of a multiple-use dispensing gun.