EP3484417A1

EP3484417A1 - Mixing and delivery system for bone replacement material

Info

Publication number: EP3484417A1
Application number: EP17733767.2A
Authority: EP
Inventors: Benjamin NIEBER
Original assignee: Medmix Systems AG
Current assignee: Medmix Switzerland AG
Priority date: 2016-07-12
Filing date: 2017-06-19
Publication date: 2019-05-22
Also published as: US20190223931A1; CN109475416A; WO2018010914A1

Abstract

A mixing and delivery system (1) and a method for impregnating granules (G) with a liquid and for delivering a resulting mixture are specified. The mixing and delivery system (1) has a container (2) for holding the granules. In a distal end region (25) of the container is arranged a separation element (4), which is designed to retain granules but allow liquid to pass through. The container has a predefined breaking point (27) proximal of the separation element (4) so that the distal end region between the predefined breaking point and the distal container end (23) can be broken off from the container together with the separation element (4), thereby creating a delivery opening on the container for delivering the mixture.

Description

TITLE

MIXING AND DISTRIBUTION SYSTEM FOR BONE REPLACEMENT MATERIAL

TECHNICAL AREA

The present invention relates to a mixing and dispensing system and a corresponding method for impregnating granules with a liquid and for discharging the mixture. STATE OF THE ART

In various medical fields, such as dentistry, orthopedics or reconstructive surgery, bone replacement materials (bone graft materials) are used. The bone substitute material usually consists of a granular (particulate) phase of natural or synthetic origin (eg a biphasic calcium phosphate / hydroxylapatite material) and a liquid phase (eg endogenous blood or a physiological sodium chloride solution). The bone substitute material usually has a pasty consistency. Conventionally, the granular material, hereinafter referred to as granules, is provided in a dish and the liquid phase is added, whereby the granules are wetted. To apply the finished bone graft material thus prepared to the patient, it is brought to the destination with a spatula. Depending on the location of the destination, this may be difficult if not impossible, and since the material is loose and piled on the spatula, there is a risk that the material may slip off the spatula as it is fed. In addition, such handling is time consuming and in the production must be taken to ensure that the granules and the liquid phase are mixed in a correct ratio with each other, so that the Bone substitute material receives the desired pasty consistency.

It has therefore been proposed in the prior art to take up the granules in a syringe and to wet them directly in the syringe with the liquid phase. In order to retain the granules in the syringe, but to allow the absorption of the liquid phase into the syringe, it is known to provide a filter or sieve on the syringe.

Thus, EP 0 470 393 B1 discloses a granular syringe in which a cap with a disk of porous material is plugged or screwed onto the outlet end of the syringe housing. To discharge the mixture, the cap is removed and a plunger is pushed forward.

EP 1 093 767 B1 discloses a syringe with a syringe barrel which is filled with granules. On the cylinder, a cannula tip is attached by means of a friction fit, which has a sieve in a recess. Through an opening, blood is sucked into the syringe barrel. If the blood is sufficiently mixed with the granules, the cannula tip is manually pushed down from the syringe barrel. From EP 2 436 342 B1 a syringe for the application of bone substitute material is known, which has a cylinder, is received in the granules. The cylinder has at its distal end an external thread on which a removable attachment is held with an internal thread. The attachment has an injection opening and drainage openings, through which liquid can be injected or sucked into the cylinder. If the bone substitute material is sufficiently saturated with liquid, the attachment is unscrewed and replaced by a curved discharge nozzle.

In such syringes, however, there is still room for improvement regarding the handling.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a mixing and dispensing system for To provide impregnation of granules with a liquid and for discharging the mixture, which ensures an effective impregnation of the granules and discharge of the mixture and thereby has an easy handling. The mixing and discharge system should also be easy and inexpensive to manufacture.

This object is achieved by a mixing and dispensing system having the features of claim 1. Further embodiments are given in the dependent claims. Thus, there is provided a mixing and dispensing system for impregnating granules with a liquid and for discharging a mixture resulting therefrom, which has a syringe-like container for receiving the granules, with a peripheral container wall, a proximal container end and a distal container end. In particular, the container may form an elongated cavity of substantially constant cross-section. The distal end of the container forms a container opening for introducing the liquid into the container. A feed element arranged displaceably in the container serves for discharging the mixture along a distal discharge direction. Disposed in a distal end portion of the container is a separator which is adapted to retain granules but to allow the passage of liquid. The container has a predetermined breaking point proximal to the separating element, so that the distal end region located between the predetermined breaking point and the distal container end can be broken off from the container together with the separating element and thereby a discharge opening for discharging the mixture is created on the container.

Due to the presence of the separating element, the granules can on the one hand be retained in the container and effectively impregnated with liquid. For example, a sieve with a plurality of defined sieve openings or a filter can serve as separating element. In particular, the separating element may be formed as a flat plastic disc manufactured by injection molding with a plurality of defined passage openings. On the other hand, the separation element can be removed after impregnation of the granules with liquid due to the predetermined breaking point in a very simple manner. The resulting mixture can be discharged directly through the thus created discharge opening, without the need for an essay or the like to be attached to the mixing and dispensing system. The handling is thereby facilitated and is very intuitive.

The Trermelement may be formed integrally with the container wall according to a first embodiment. An integrally formed respectively integrally with the container wall separating element has the advantage that a production of the container together with the separating element can be carried out in the same manufacturing step. This can be done in particular by injection molding. According to further embodiments, however, the separating element may also be formed separately from the container. This has the advantage that the release agent can be very easily adapted to the requirements of different types of granules and liquid phase, e.g. to different particle sizes of the granules, without the need to change the injection mold of the entire container. It can be made a single type of container, which can then be provided depending on the requirements with the appropriate separator. In this case, the release agent can be made depending on the requirements of the same or a different material than the container.

Advantageously, the separating element is at least fixed against displacement along the distal discharge direction, preferably also in the opposite (proximal) direction in the container. For this purpose, the container wall may have at least one corresponding retaining means (eg in the form of at least one inwardly projecting projection in the form of a nose or a circumferential bead, or in the form of an inside groove), which supports the separating element against displacement at least in the distal, preferably also in the proximal direction is fixed in the container.

In addition, the release agent may be secured against rotation about the longitudinal axis of the container by the same or other retention means engaging the release means along the circumference. This is particularly advantageous when the release agent is initially connected to a closure, as will be described in more detail below.

The mixing and dispensing system further preferably comprises a removable closure on to close the container opening. The provision of a closure prevents contamination of the container opening and of the container contents from occurring prior to use of the mixing and dispensing system due to environmental influences. For the use of the mixing and dispensing system, the closure is removed from the container so that the liquid can be received in the container through the container opening. After impregnation of the granules with the liquid, the closure can be re-attached to the container if necessary to re-close the container opening. The closure can serve as a break-off aid for easier termination of the distal end region.

It is preferred if the closure has a stopper which extends counter to the discharge direction through the container opening to the separating element into the distal end region of the container. Such a closure prevents the transport of prefilled mixing and application system fine granules ("dust"), which are often inevitably present in the granules pass through the openings of the separator and accumulate between the separator and the closure.

The closure may e.g. be fixable by a pure plug connection on the container. Alternatively, it can be fixed by means of a threaded connection to the container. In this case, different embodiments of a threaded connection are conceivable. For example, the closure may have an internal thread which engages with a corresponding external thread on a distal outer side of the container when the closure is screwed or axially pressed onto the container. On the other hand, an external thread on the stopper is conceivable, which engages with a corresponding internal thread on a distal inner side of the container wall when the stopper is screwed into the container opening or pressed in axially. In particular, it is preferable to provide a round thread or saw thread, so that the closure against the discharge direction can be easily pressed onto the container opening or pressed into the container opening, but can only be removed again from the container opening via a screwing along the discharge direction.

In advantageous embodiments, the closure is initially with the separating element connected, wherein the separating element is fixed to the container such that the separating element remains in the container when the closure is removed from the container. This has the advantage that the separating element when assembling the mixing and dispensing system can be very easily introduced into the container. The separating element thus automatically reaches the intended location in the distal end of the container when the closure is attached to the container.

In this case, the closure is preferably formed in one piece with the separating element and in particular connected to the separating element via a predetermined breaking point. The unit of closure and separating element can in turn be produced by injection molding.

In this case, it is of particular advantage if the closure is fixed to the container via a threaded connection, in particular with round or saw thread, as described above. In this case, the closure together with the separating element can be connected to the container during assembly of the mixing and discharge system by axial pressing or pressing. Preferably, the separating element engages in the retaining means of the container wall and is thereby fixed in the container. Subsequently, the closure can be solved without aids only by a screw again from the container. The connection between the closure and the separating element ruptures without the user having to use excessive forces. The separation of the closure from the separating element succeeds particularly easily when the separating element is fixed not only axially, but also with respect to rotations in the container. In this case, act on the connection between the closure and separating element when unscrewing the closure not only tensile forces, but also torsional forces, which facilitates the separation of the compound.

Preferably, the container has a curvature and forms, distally of the curvature, an angled portion which extends outwardly from the central longitudinal axis with respect to a central longitudinal axis of the container, the angled portion preferably being at a bend angle between 20 ° and 50 ° extends outwardly away from the central longitudinal axis, and wherein the distal end portion is disposed in the angled portion. In other words, thus are the separating element and the predetermined breaking point in the angled portion of the container, so that the discharge opening after the distal end portion has been broken off, is also located in the angled portion of the container. Such an angled design of the container allows the user a targeted discharge of the mixture at the site.

In order to enable the user to facilitate the termination of the distal end region from the container, break-off aids can be provided at the distal end region. For example, may be provided on the outside of the distal end portion longitudinal ribs, retaining wings or transverse grooves, which are included by the user for the Abbruchvorgang and provide a better grip.

The feed element preferably has a piston which is connected to a piston rod. In order to reduce the friction between piston rod and container inner wall, it is advantageous if the piston rod has an outer diameter which is smaller than the inner diameter of the container. In order nevertheless to ensure a good guidance of the piston rod, annular guide beads can be formed on the peripheral surface of the piston rod. If the container has a curvature, it is also advantageous if the piston rod has a region of reduced outer diameter in a distal region, the reduced diameter being smaller than the outer diameter in the proximal region. In this way, the piston rod becomes more flexible and can follow the curvature more easily. Even in the area of reduced outside diameter, ring-shaped guide beads can be attached to the piston rod so that good guidance of the piston rod in the container is nevertheless ensured.

The container may be prefilled with granules having an average granule diameter. The separating element then preferably has passage openings whose diameter is smaller than the average granule diameter.

The mixing and discharging system described above can be used as follows. First, the mixing and discharge system is provided with granules, and the granules is soaked in a liquid. In order to create the discharge opening for discharging the mixture to the container, the distal end region is broken off together with the separating element at the predetermined breaking point. To discharge the mixture from the discharge port, the piston rod is displaced along the distal discharge direction.

Preferably, the impregnation of the granules is carried out by absorbing the liquid by the feed element is moved counter to the discharge. For example, the discharge opening can be immersed in a reservoir with liquid. Alternatively, the impregnation of the granules can be effected by injecting the liquid through the container opening and the separating element. For example, a moistening syringe can be filled with liquid for this purpose, wherein the syringe cannula is guided through the separating element and thus supplies the liquid to the granules. It is advantageous if the cannula is inserted through an already prefabricated opening of the separating element into the container.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will be described below with reference to the drawings, which are given by way of illustration only and are not to be interpreted as limiting. In the drawings show:

1 shows a perspective view of a mixing and discharge device with a closure according to a first embodiment;

Fig. 2 shows a central longitudinal section through the mixing and discharge of the

FIG. 1;

3 shows a detailed view of the region A of FIG. 2 with a separating element according to a first embodiment;

4 shows a detailed view of the region A of FIG. 2 with a separating element according to a second embodiment;

Fig. 5 is a detail view of the area A of Figure 2 with the separator of the first embodiment, but a closure according to a second

embodiment; 6 shows a perspective view of the mixing and discharging device of FIG. 1 with a closure according to a third embodiment;

Fig. 7 shows a central longitudinal section through the mixing and discharge of the

Figure 6;

Fig. 8 is a detail view of area B of Fig. 7;

9 shows a central longitudinal section through a mixing and discharging device with a closure according to a fourth embodiment, wherein the closure forms a unit with a separating element according to a third embodiment;

Fig. 10 is a detail view of the area C of Fig. 9;

1 1 shows a detailed view of the region C of FIG. 9 with a closure according to a fifth embodiment, wherein the closure forms a unit with a separating element according to a fourth embodiment;

12 shows a detailed view of the region C of FIG. 9 with a closure according to the fifth embodiment and a separating element according to a fifth embodiment

embodiment;

13 shows a detailed view of the region C of FIG. 9 with a closure according to a sixth embodiment and a separating element according to the fourth embodiment;

14 shows a detail view of the region C of FIG. 9 with a closure according to the sixth embodiment and a separating element according to the fifth embodiment

embodiment;

Fig. 15 is a detail view of the area D of Fig. 13;

Fig. 16 is a detail view of the area E of Fig. 14;

Fig. 17 is a central longitudinal section through the mixing and discharge of the

Figure 9 after the closure has been removed;

Fig. 18 is a detail view of the area H of Fig. 17;

19 shows an illustration of a filling process according to a first variant;

20 shows an illustration of a filling process according to a second variant;

Fig. 21 is a detail view of the area G of Fig. 20;

FIG. 22 shows a central longitudinal section through a mixing and discharging device with broken end region; FIG.

Fig. 23 is a detail view of the area H of Fig. 22; a perspective view of a container of the mixing and discharge device with break-off aid according to a first embodiment; a perspective view of a container of the mixing and discharge device with break-off aid according to a second embodiment;

a perspective view of a container of the mixing and discharge device with break-off aid according to a third embodiment;

a central longitudinal section through a mixing and discharging device after the removal of the end portion in an initial state, at the beginning of the discharge process;

the mixing and discharging device of Figure 27 in an intermediate state after a part of its contents has been discharged; and

the mixing and discharging device of Figure 24 in a final state after the contents have been completely discharged.

DESCRIPTION OF PREFERRED EMBODIMENTS In FIGS. 1 to 3, a first embodiment of a mixing and discharging device 1 according to the invention is illustrated in various views. The mixing and discharging device 1 comprises a container 2 with a separating element 4 and a feed element 3 displaceably arranged in the container 2 for discharging a mixture along a distal discharge direction L. The container 2 is closed by a closure 5.

The distal discharge direction L is defined as the direction along which the feed element 3 moves into the container 2 to discharge the mixture from the container 2. The opposite direction is called the proximal direction.

The container 2 has a peripheral container wall 21, which delimits a cylindrical container interior 215 for receiving a granulate G, as well as a proximal container end 22 and a distal container end 23. The proximal end of the container 22 forms an insertion opening 216, which opens into the container interior 215. After the granules G has been filled into the container 2 via this insertion opening 216, the feed element 3 is also introduced through the insertion opening 216 into the container 2. At the proximal end 22, the container 2 has a holding plate 212 which revolves around the central longitudinal axis Z. Alternatively, of course, holding wings may be provided, as is common practice in syringes. The distal container end 23 forms a container opening 24 for receiving a liquid F into the container interior 215. As can be seen in particular from FIG. 3, the separator 4 is arranged in the form of a filter or sieve in a distal end region 25 of the container 2. It serves to retain the granules G in the container interior 215, but to allow the passage of liquids F into the container interior 215.

The advancing element 3 has a piston rod 37, at the distal end 33 of which a piston 39 is formed. At its proximal end 32, the piston rod 37 has a pressure plate 31 designed as a thumb rest, which is designed to advance the piston rod 37 along the distal discharge direction L in order to discharge the mixture or withdraw it against this discharge direction in order to receive liquid into the container 2.

As will be explained in detail below in connection with FIGS. 22 to 26, the container 2 has a predetermined breaking point 27 proximal to the separating element 4, so that the distal end region 25 of the container 2 lying between the predetermined breaking point 27 and the distal container end 23 together with the separating element 4 is breakable from the container 2, whereby a discharge opening 28 for discharging the mixture is formed on the container 2.

As further shown in Figures 1 and 2, the container 2 has a curvature region 29 and forms an angled portion 213 distally of the curvature. The angled portion 213 extends with respect to a central one Longitudinal axis Z of the container 2 in a curvature angle α of about 30 ° from the central longitudinal axis Z to the outside. Proximal of the curvature of the container 2 has a straight portion 214, which extends parallel to the central longitudinal axis Z of the container 2.

As can be seen in particular in FIG. 2, the separating element 4 is arranged distally from the straight region 214 in the angled section 213 of the container 2. The separating element 4 completely fills the clear cross-section of the container interior 215 and is manufactured in one piece with the container wall 21.

So that liquids can be received in the container interior 215, the separating element 4 has passage openings 41, which extend completely along the discharge direction L through the separating element 4. On the one hand liquids can be taken up in the container 2, but at the same time the granules G remains in the container 2, the passage openings 41 have a diameter which is smaller than the average granule diameter. For example, the separating element 4 may be a sieve having a multiplicity of round openings with a diameter of 0.6 mm, so that granulate G with an average granule diameter of approximately 1 mm is retained in the container interior 215. The mean granule diameter here means the average particle size, determined by a sieve analysis according to DIN EN 933-1: 2012-03. Distal from the separating element 4 is the container opening 24, through which the liquid F can be received in the container 2 and which is closed before use of the mixing and dispensing system 1 with the removable closure 5.

In Figure 4, a separating element 4 'is shown according to a second embodiment, which, in contrast to the integrally formed separating element of Figures 1 to 3, is formed separately from the container 2 and can be subsequently inserted into the container interior 215.

As can be seen from FIGS. 1 to 4, the closure 5 has a plug 57 and is inserted with the latter into the container opening 24. In the distal direction, the closure 5 projects beyond the distal container end 23 and is provided with a handle 53 provided, which can be taken by a user for the removal of the shutter 5 well.

While the closure 5 in this case only partially projects into the container opening 24 and is arranged at a distance from the separating element 4 in the container 2, the closure may however also have a stopper which extends through the distal end region 25 all the way to the separating element 4. Such a closure 5 'is shown in Figure 5 and has the additional advantage that it prevents fine granules whose diameter is smaller than the diameter of the passage openings 41 of the separating element 4, in the distal end region 25 between the separating element 4 and the sealing plug accumulate.

The mixing and discharging device 1 of Figures 6 to 8 has a closure according to a second embodiment, wherein the closure as a closure cap 5 "is formed and here has an internal thread 52. The container 2 has the outside in the region of the container opening 24 has a corresponding external thread 21 1, so that the closure cap 5 "can be screwed onto the distal container end 23. However, it is also conceivable that the closure cap 5 "is formed without an internal thread and that the container 2 has no external thread, so that the closure cap 5" is attached solely to the distal container end 23. It is also conceivable that the closure cap 5 "also has a stopper 57 which extends through the distal end region 25 as far as the separating element 4. The closure cap 5" here is provided with holding wings 55, 55 'for easier handling. 9 to 16 show various combinations of closures 5 "', 5"",5""', each having a separating element 4", 4 "', 4"", in all these embodiments, the closure 5"', 5 "", 5 ""'are each initially connected to the separating element 4 ", 4"', 4 "", wherein the separating element 4 ", 4"', 4 "" is fixed to the container 2 such that the separating element 4 " 4 "', 4""remains in the container 2 when the closure 5"', 5 "", 5 ""'is removed from the container 2. For this, the closure 5 "', 5"",5""' in one piece via a predetermined breaking point 51 with the separating element 4 ", 4"', 4 "" connected. Such an embodiment allows a simplified production of the mixing and dispensing system 1, since the joint production of the separating element 4 ", 4"', 4 "" and the closure 5 "', 5"",5""'compared to a production of the container 2 with integrated separating element 4 is simpler only for production-technical reasons Moreover, a separating element 4 ", 4"', 4 "" connected to the closure 5 "', 5"",5""'also facilitates the assembly of the separating element 4 ", 4"', 4 "" in the container 2, since the separating element 4 ", 4"', 4 "" can be introduced into the container 2 by means of the closure 5 '", 5"",5""' In addition, a separate production of the separating element 4 ', 4 ", 4"', 4 "" also permits adaptations of the mixing and discharging device 1 to different types of granules for the same container design, since the separating element 4 ', 4 ", 4"', 4 "" with different passage openings 41', 41 ", 41"', 41 "" can be provided, the grain size of the respective Correspond to granules.

Thus, a displacement of the separately formed partition member 4 "in the container interior 215 in the proximal and distal direction is prevented, the container wall 21 according to Figure 10 inwardly projecting retaining means in the form of protrusions 210, 210 ', 210", 210 "', which are arranged proximally and distally of the separating element 4 "and thus fix the separating element 4" in the container 2. The projections 210, 210 ', 210 ", 210"' are formed integrally with the container wall 21 and extend from the container wall 21 in Direction of the container interior 215 at least partially along the proximal side 42 and the distal side 43 of the separating element 4 ", wherein the projections 210, 210 ', 210", 210 "' directly adjacent to the proximal and distal sides 42, 43 of the separating element 4" Alternatively or additionally, however, the separating element 4 "', 4""may have lateral recesses 44, 44', 44" into which the projections 210, 210 'engage n and the separating element 4 "', 4""thus fix with respect to a rotation in the container 2. As can be seen in particular from FIGS. 11, 13 and 15 or 12, 14 and 16, the separating element 4 "'can project, for example, on both sides with two projections 210, 210' which project into corresponding lateral recesses 44, 44 'in a separating element edge ( see FIG. 15) or on both sides, each with a projection 210 which projects into a laterally centrally formed recess 44 "in the separating element 4""(see FIG. 16), being fixed in the container 2. Next, in the figures 11 to 16 of the closure 5 "", 5 "'" fixed in each case via a threaded connection to the container 2. As shown in FIGS. 11 and 12 or 13 and 14, the container wall 21 can have a round thread 211 'or a saw thread 211 "on the inside in the distal end region 25, which has a corresponding external thread 52', 52" on the sealing plug 5 "". , 5 ""'engages. The provision of such a threaded connection has the advantage that the closure 5 "", 5 ""'together with the separating element 4'",4""can be pushed into the container 2 during assembly in the proximal direction through the container opening 24. A subsequent Removing the closure 5 "", 5 ""'by pulling on the closure in the distal direction is achieved by the between the internal thread 211', 211 "of the container 2 and the external thread 52 ', 52" of the closure 5 "", 5 ""' Instead, the closure 5 "", 5 "" can be removed from the container 2 solely by means of a screwing action. By virtue of the screwing action, both tensile forces and torsional forces act simultaneously when the closure 5 "", 5 ""'is removed on the predetermined breaking point 51 between the separating element 4 "', 4""and the closure 5"",5""', so that the predetermined breaking point 51 breaks with less force than would be the case with a pure axial peeling. After the closure 5, 5 ', 5 ", 5"', 5 "", 5 "'" has been removed from the mixing and discharging device 1, the container opening 24 is released. This state is shown in FIGS. 17 and 18.

The granulate G in the container interior 215 is now soaked with liquid F. One possibility for impregnating the granulate G consists, as shown in FIG. 19, in that the liquid F is absorbed into the container interior 215. For this purpose, the mixing and dispensing system 1 is immersed with its released container opening 24 in a reservoir with liquid F, and a suction of the liquid takes place in that the feed element 3 is withdrawn against the discharge L in the container 2. In this case, the impregnating liquid passes through the passage openings 41, 4, 41 ", 4", 41 "" of the separating element 4, 4 ', 4 ", 4"', 4 "" into the container interior 215.

Another possibility for impregnation of the granules G is shown in Figure 20, wherein Liquid F is injected through the container opening 24 and through the passage openings 41, 4, 41 ", 41 '", 41 "" of the separating element 4, 4', 4 ', 4 ", 4"', 4 "" into the container interior 215 becomes. For this purpose, a moistening syringe 6 can be used, the syringe cannula 61 of which has an outer diameter which is equal to or smaller than the diameter of the passage openings 41, 41 ', 41 ", 41"', 41 "" of the separating element 4, 4 ', 4 ", 4 '", 4""is. As a result, the syringe cannula 61 can be inserted directly through the passage openings 41, 41 ', 41 "without firstly piercing the separating element under the force of the force.From the granules G was impregnated with the liquid, the finished bone substitute material can be discharged from the mixing and discharging device 1 For this, however, the separating element 4, 4 ', 4 ", 4"', 4 "" must be removed from the mixing and discharging device 1. As already mentioned, the container 2 has proximally from the separating element 4, 4 ', 4 ". , 4 "', 4""via a predetermined breaking point 27, so that the distal end region 25 located between the predetermined breaking point 27 and the distal container end 23 together with the separating element 4, 4', 4", 4 "', 4""from the container This is illustrated in Figures 22 and 23. As shown in Figures 27 to 29, a discharge port 28 for discharging the mixture is thereby provided in the container 2. As further shown in Figures 22 and 23, the present invention is incorporated herein by reference the predetermined breaking point 27 in the angled portion 213 of the container 2, so that the discharge opening 28 after the distal end portion 25 has been stopped, also in the angled portion 213 of the container 2 is located.

As can be seen in FIGS. 24 to 26, the distal end region 25 of the container 2 may have an external snap-off aid, for example in the form of longitudinally extending ribs 217, retaining wings 217 'or transverse grooves 217 ", which give the user better grip and As a result, it is also possible for the closure cap to serve as a break-off aid If, for example, the closure cap 5 "of FIG. 6 is again placed on the distal container end 23 after impregnation of the granulate G, these holding wings 55, 55 Of course, all the closures disclosed herein may be re-applied to the distal container end 23 after impregnation of the granules applied and taken for breaking the distal end portion 25.

The container 2 is formed in the present embodiments as a cylindrical tube which defines a constant inner diameter DB. In order to reduce the friction between the container wall and the piston rod, the piston rod 37 of the advancing element 3 has an outer diameter in a proximal region 34, which is a little smaller than the inner diameter DB of the container 2. In order nevertheless to ensure a good guidance of the piston rod 37 in the container interior 215, the piston rod 37 radially outwardly projecting, circumferential, annular Führungswülste 38, 38 ', 38 ", 38"', which bear against the container wall 21. So that the piston rod 37 can also follow the angled section 213 of the container 2 well, the piston rod 37 has a region of further reduced diameter 36 in a distal region 35. The reduced diameter DK of the piston rod 37 is smaller than the diameter in the proximal region 34 of the piston rod 37, which gives the piston rod 37 in the distal region of the container 2 a good flexibility.

FIG. 27 shows the mixing and discharging device 1 in the initial state, at the beginning of the discharge of the mixture. The distal end region 25 of the container 2 was broken off together with the separating element 4, 4 ', 4 ", 4"', 4 "" and the piston rod 37 was retracted in the proximal direction and extends parallel to the central longitudinal axis Z.

In FIG. 28, the mixing and discharging device 1 is shown in an intermediate state, wherein the piston 39 has been partially advanced into the container 2 along the distal discharge direction L and has discharged part of the mixture. If now the piston 39 is advanced further in the distal direction, then both the piston 39 and the distal region 35 of the piston rod 37 follow the angled portion 213 of the container 2, whereby this flexibility of the piston rod 37 in particular by the reduced diameter portion 36 of the piston rod 37th is guaranteed.

Figure 29 shows the final state in which the piston 39 has been advanced to the outlet opening 28 of the container 2 in the distal direction and the piston rod 37 completely received in the container interior 215. The length dimension of the piston 39 and the area of tapered diameter 36 corresponds to the length dimension of the angled portion 213 of the container 2. As shown in FIG. 28, the piston 39 and the guide bead 38 seal against the container wall 21 of the container 2.

LIST OF REFERENCE NUMBERS

1 mixing and discharge system

2 containers

21 container wall

22 proximal end of the container

23 distal end of the container

24 container opening

25 distal area

27 predetermined breaking point

28 discharge opening

29 curvature area

210-210 "'retention means

21 1-21 1 "thread

212 retaining plate

213 angled section

214 straight area

215 container interior

216 insertion opening

217-217 "Cancellation aid

3 feed element

31 pressure plate

32 proximal end

33 distal end

34 proximal area

35 distal area

36 rejuvenation

37 piston rod

38 guide bead

39 pistons

4_4 "" separator

41-41 "" ports

42 proximal side 43 distal side

44-44 "lateral recess

45 separator edge

5-5 "" 'shutter

51 predetermined breaking point

52-52 "thread

53 Grab handle

54 proximal extension

55, 55 'retaining wing

57 plugs

6 humidifying syringe

61 syringe cannula

L Discharge direction Z Central longitudinal axis α Curvature angle

DB container diameter

DK piston diameter

G granules

F liquid

Claims

1. Mixing and dispensing system (1) for impregnating granules (G) with a liquid (F) and for discharging a mixture resulting therefrom, comprising:

a container (2) for receiving the granules (G), comprising a peripheral container wall (21), a proximal container end (22) and a distal container end (23), the distal container end (23) having a container opening (24) for inserting the Liquid (F) forms in the container (2);

a feed element (3) mounted displaceably in the container (2) for discharging the mixture along a distal discharge direction (L); and

a separating element (4, 4 ', 4 ", 4"', 4 "") arranged in a distal end region (25) of the container (2), which is designed to retain granules (G) but prevents the passage of liquid ( F) to allow;

characterized in that

the container (2) has a predetermined breaking point (27) proximal to the separating element (4, 4 ', 4 ", 4"', 4 ""), so that the distal end located between the predetermined breaking point (27) and the distal container end (23) End region (25) together with the separating element (4, 4 ', 4 ", 4"', 4 "") from the container (2) can be broken off and thereby on the container (2) a discharge opening (28) for discharging the mixture is created ,

2. mixing and dispensing system (1) according to claim 1, wherein the separating element (4) is formed integrally with the container wall (21).

3. mixing and dispensing system (1) according to claim 1, wherein the separating element (4 ', 4 ", 4"', 4 "") is formed separately from the container (2).

4. mixing and dispensing system (1) according to claim 3, wherein the container wall (21) at least one retaining means (210, 210 ', 210 ", 210"'), which the separating element (4 ', 4 ", 4"' , 4 "") fixed at least with respect to the distal discharge direction (L) in the container (2).

5. mixing and dispensing system (1) according to claim 4, wherein at least one of the retaining means (210, 210 ', 210 ", 210'"), the separating element (4 ', 4 ", 4"', 4 "") with respect to rotations fixed in the container (2).

6. mixing and dispensing system (1) according to one of the preceding claims, further comprising a removable closure (5, 5 ', 5 ", 5"', 5 "", 5 "" ') to the container opening (24) closure.

7. mixing and dispensing system (1) according to claim 6, wherein the closure (5, 5 ', 5 ", 5"', 5 "", 5 "" ') has a plug (57) which opposes the discharge direction extends through the container opening (24) to the separating element (4, 4 ', 4 ", 4"', 4 "") into the container (2).

8. mixing and dispensing system (1) according to claim 6 or 7,

the closure (5 "', 5" ", 5" "') being connected to the separating element (4", 4 "', 4" "), and

wherein the separating element (4 ", 4 '", 4 "") is fixed to the container (2) such that the separating element (4 ", 4"', 4 "") remains in the container (2) when the closure ( 5 "', 5" ", 5" "') is removed from the container (2).

9. mixing and dispensing system (1) according to claim 8, wherein the closure (5 "', 5" ", 5" "') in one piece with the separating element (4", 4 "', 4" ") is formed.

10. mixing and dispensing system (1) according to claim 9, wherein the closure (5 "', 5" ", 5"' ") via a predetermined breaking point (51) with the Trermelement (4", 4 "', 4" " ) connected is.

11. mixing and dispensing system (1) according to one of the preceding claims, wherein the container (2) has a curvature (29) and distally of the curvature (29) forms an angled portion (213), which with respect to a central longitudinal axis ( Z) of the container (2) extends outwardly away from the central longitudinal axis (Z), wherein the angled portion (213) preferably extends outwardly at a bend angle (a) between 20 ° and 50 ° from the central longitudinal axis (Z), and

wherein the distal end portion (25) is disposed in the angled portion (213).

12. mixing and dispensing system (1) according to claim 11,

the container (2) defining an internal diameter (DB), the advancing element (3) having a piston (39) connected to a piston rod (37), and the piston rod (37) in a distal region (35). has an area of reduced outside diameter (36),

wherein the reduced outer diameter (DK) is smaller than the inner diameter (DB), so that the piston rod (37) in the region of the reduced outer diameter (36) from the container wall (21) is spaced, and

wherein the piston rod (37) in the region of reduced outer diameter (36) has at least one radially outwardly projecting guide bead (38), which rests against the container wall (21).

13. mixing and dispensing system (1) according to one of the preceding claims, wherein the container (2) with granules (G) is prefilled with a mean granule diameter, and

wherein the separating element (4, 4 ', 4 ", 4"', 4 "") has passage openings (41, 41 ', 41 ", 4", 41 "") whose diameter is smaller than the average granule diameter.

14. A method for impregnating granules (G) with a liquid (F), comprising:

Providing a granulate (G) prefilled mixing and dispensing system (1) according to one of the preceding claims;

Impregnating the granules (G) with a liquid (F);

Canceling the distal end portion (25) together with the separating element (4, 4 ', 4 ", 4"', 4 "") at the predetermined breaking point (27) to the discharge opening (28) for discharging the mixture to the container (2) to create; and

Displacing the piston rod (37) along the distal discharge direction (L) to discharge the mixture from the discharge port (28).

15. The method according to claim 14, wherein the impregnation of the granules (G) by sucking the liquid (F) takes place by the feed element (3) against the discharge direction (L) is moved.

16. The method of claim 14, wherein the impregnation of the granules (G) by injecting the liquid (F) through the container opening (24) and the separating element (4, 4 ', 4 ", 4"', 4 "") takes place therethrough ,

17. The method according to claim 16, wherein the injection of the liquid (F) takes place by a cannula (61) through prefabricated openings of the separating element (4, 4 ', 4 ", 4"', 4 "") in the container (2 ) is introduced.