Abstract:
The device for storing, mixing, and dispensing components is provided with means for mixing ( 6 ) a first component ( 27 ) with a second, liquid component ( 28 ) and for dispensing the mixed materials. The individual components ( 27, 28 ) are stored in respective containers ( 2, 3 ) that are arranged side by side, and a valve assembly ( 8 ) is arranged in the transfer area ( 7 ) between the outlet area ( 26 ) of the container ( 3 ) for storing the second, liquid component ( 28 ) and the liquid inlet ( 25 ) of the container ( 2 ) for storing the first component ( 27 ). Such a device allows an unproblematic storage of the different components without a local separation of the containers and an efficient mix thereof. This applies especially if the first component is a powder or a granular or porous substance, e.g. bone cement or bone replacement material.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to a device and method for storing, mixing and dispensing components, comprising means for mixing a first component with a second, liquid component and for dispensing the mixture, according to the preambles of claims  1  and  15 . The first component may be a powdery, granular, or porous bone replacement material or bone cement or a similar material for use in medicine or dentistry. 
     Devices according to the preamble of claim  1  are available on the market and generally comprise a container in which the powdery material is stored and to which the liquid component is added, the components being subsequently mixed and the mixture being dispensed by means of a piston. 
     The locally separated storage of at least two components may add complexity to stockkeeping and make the admixture of the smaller, liquid component problematic, e.g. due to confusion. 
     Further devices where the components are stored separately are known in the art, the smaller, liquid component being e.g. stored behind the piston or thrust rod of the chamber for the larger, powdery component. Arrangements of this kind generally comprise a valve that is arranged between the components and through which the liquid component may be supplied to the powdery component. The disadvantage of this solution is that no controllable transfer of the components is possible. U.S. Pat. No. 3,370,754 may be cited as an example standing for a number of references regarding this prior art. 
     A set for preparing and applying a tissue adhesive is known from EP-0 292 472, where in each case four syringe bodies are combined in pairs via a coupling member to form a respective unit. The coupling member comprises respective cones for receiving corresponding conical portions on the syringes. The reference only discloses a connection between two adjacent syringes, however without a valve arrangement, so that the possible applications are limited. 
     U.S. Pat. No. 6,402,364 discloses a dispenser for colored cosmetic compositions where a centrally arranged syringe is arranged to aspirate colors from one or another adjacent container via a screw lid having a channel in order to mix and dispense them. Such an arrangement is unsuitable for the medical field. 
     WO 00 35506 discloses a container for a powder and a container for a liquid for the preparation of bone cement where a coupling for vacuum is necessarily required, the connection between the two containers being basically always open and the container for the liquid being opened just before the mixing operation. However, selectively establishing a connection between the containers is not possible. 
     On the background of this prior art, it is the object of the present invention to provide a device and a method for storing, mixing, and dispensing components, more particularly powdery, granular, porous and liquid materials that allows a simple handling and arrangement of the containers while the components are fully separated during storage, and a simple control of the introduction of the second, liquid component into the first component, and that offers a wide range of applications such as external aspiration or introduction of a liquid into the dispensing device. The device attaining this object is defined in claims  1  and  15 . 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be explained in more detail hereinafter with reference to drawings of exemplary embodiments. 
         FIG. 1  shows a first exemplary embodiment of a device of the invention, partly sectioned and in a perspective view, 
         FIG. 2  schematically shows a detail of the solution according to  FIG. 1 , 
         FIG. 3  shows a first exemplary embodiment of a valve in a section of  FIG. 2 , 
         FIGS. 4-7  show different method steps during the transfer of one component into the other as well as during mixing and dispensing of the conditioned mixture in the device according to  FIG. 1 , 
         FIG. 8  shows an embodiment variant having a piston without a thrust rod for the second, liquid component, 
         FIG. 9  shows a second exemplary embodiment of the dispensing piston without a thrust rod, 
         FIG. 10  shows another exemplary embodiment having a vacuum coupling, 
         FIG. 11  shows another exemplary embodiment of a device according to the invention, 
         FIG. 12  shows the device of  FIG. 11  in a different outlet configuration and position of a thrust rod, 
         FIG. 13  shows a perspective view of another exemplary embodiment of a device according to the invention for aspirating a liquid, mixing the latter with a powder, and dispensing the mixture, 
         FIG. 14  shows the device of  FIG. 13  in a partial longitudinal section just before use, 
         FIG. 15  shows the device of  FIG. 14  after the transfer of the liquid, 
         FIG. 16  shows an enlarged detail of the inlet/outlet area in the form of a three-way valve of the syringe of  FIG. 13  and a section A according to line A-A, 
         FIG. 17  shows the inlet/outlet of  FIG. 16  in a different section plane and a section B according to line B-B, 
         FIG. 18  shows the inlet/outlet of  FIG. 16  in a further section plane and a section C according to line C-C, 
         FIG. 19  shows the closed position of the valve in a fourth section D, 
         FIG. 20  shows a further outlet accessory, 
         FIG. 21  shows a two-component syringe having separate storage containers, and 
         FIG. 22  shows the assembled two-component syringe of  FIG. 21 . 
         FIG. 23  shows a three-component syringe having separate storage containers, and 
         FIG. 24  shows the assembled three-component syringe of  FIG. 23 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  schematically shows the basic structure of a device  1  of the invention in a first embodiment including a container  2  for a powdery material, a container  3  for a liquid material, a piston assembly  4  for dispensing the mixed materials, a piston assembly  5  for transferring the liquid component to container  2 , and a mixing arrangement  6  for mixing the powdery and the liquid components in container  2 , as well as a transfer area  7  between outlet area  26  of second container  3  and inlet  25  of first container  2 . At the rear, the containers are provided with retaining flanges  51 . 
     Alternatively, instead of a powdery material, the first component may be a liquid, granular, porous, or pasty material to which a liquid is admixed prior to dispensing. Hereinafter, however, reference is made to a powdery material by way of example, and for the sake of simplicity, the first container is designated as the powder container and the second or third container as the liquid container. Also, the dispensing devices may be commercial cartridges. Moreover, the term “mixing” here also includes the dissolution of one component in another. 
     Container  2  for the first component, a powdery material  27 , and container  3  for the second, liquid component  28  are arranged side by side and separated by an air gap so that the risk of diffusion from one container to the other is substantially excluded. The side by side arrangement requires a connection between the liquid component and the powdery material, and means for selectively closing or opening the connection between the containers must be provided in transfer area  7 . This is advantageously realized by a valve arrangement  8  as described below. 
     Mixing arrangement  6  is essentially composed of a mixing rod  9  that is movable back and forth in the container and provided with a turning knob  10  and a mixing member, in the present example a mixing disk  11 , which is either perforated as in the present example and/or provided with peripheral cutouts or has another suitable design. Mixing disk  11  is capable of being both rotated and moved back and forth by means of the mixing rod and the turning knob in order to ensure a thorough mix of the powdery material and the liquid component. 
     The mixing arrangement is no longer used after the mixing operation, and therefore, as illustrated in  FIG. 1 , mixing rod  9  is provided with a predetermined breaking point  12  at the height of thrust plate  13  of the piston assembly approximately. At this point, the projecting end of the mixing rod including the turning knob can be broken off. 
     A mixing arrangement including a mixing rod that extends through the piston, a turning knob, and a mixing disk may also be used for other syringes or dispensing appliances without a valve arrangement. 
     With regard to the piston assembly for the second, liquid component, two variants are generally possible, i.e. a piston assembly having a piston  14  and thrust rod  15  or a piston assembly according to  FIG. 8  having only a piston  14  that is displaceable by negative pressure. 
       FIGS. 1-3  illustrate a first embodiment of valve arrangement  8  that is in the form of a valve cap  17  having an enclosure  18  with a bracket  18 B and two bayonet lugs  18 A engaging in corresponding sockets  16  and  20  arranged on enclosure bottom  53  of container  2  and enclosure bottom  54  of container  3 . Inside cap enclosure  18 , a plug assembly  19  of two pairs of plugs  21  and  22  is arranged that is reversible with respect to the enclosure and comprises a knob  19 A that projects from the enclosure. Plugs  21  are solid and serve as closures of transfer area  7 , whereas plugs  22  are provided with respective bores  23  that are interconnected by a connecting channel  24 , as appears in  FIG.3 . 
     Depending on which pair of plugs is inserted in inlet  25  of container  2  and outlet  26  of container  3 , the two containers are either connected to each other or not. By removing the cap, rotating the plugs by 90° and reconnecting it by means of the bayonet lock, the connection is selectively interrupted or established. 
       FIGS. 4-7  illustrate four different phases in the application of a device according to  FIG. 1 . In the illustration of  FIG. 4 , piston assembly  5  has been operated to inject liquid  28  into container  2 , and according to  FIG. 5 , after changing the valve from open to closed, it has been mixed with powder  27  by means of mixing arrangement  6 . 
     In the illustration of  FIG. 6 , the mixer rod end of the mixing arrangement has been broken off at the predetermined breaking point and then removed so that the device is ready for dispensing after removing the valve cap. In the illustration of  FIG. 7 , a dispensing tip  29  has been attached and the mixture dispensed by piston assembly  4 . 
     In the embodiment variant according to  FIG. 8 , piston  14  in container  3  is actuated by negative pressure rather than by a thrust rod. By retracting piston assembly  4  with piston  35  from an intermediate position, a negative pressure is generated by which piston  14  in container  3  is moved in the direction of outlet  26 . To this end, there must be an open connection between outlet  26  and inlet  25 . In this variant it is useful if the wall of container  2  comprises an internal groove or bead and piston  35  comprises corresponding means for preventing it from being pulled out completely. 
     In another embodiment variant according to  FIG. 9 , piston  58  of the cartridge or of container  2  is not actuated by a thrust rod that is connected thereto but by the thrust rod of a dispensing appliance, and predetermined breaking point  59  of mixing rod  9  is nearer to the piston. Piston  58  should have a sufficient axial length to prevent canting of piston  58  when the mixing rod is broken off at predetermined breaking point  59 . 
     In an application of the arrangement under vacuum according to  FIG. 10 , a vacuum source is connected to empty liquid container  3  that communicates with powder container  2  and applies vacuum to the latter in order to mix under vacuum.  FIG. 10  illustrates the inlet end  36  of container  3  in whose closure a filter  37  is incorporated. Internal diameter D 2  of the inlet end is larger than that D 1  of the rest of the container, thereby forming a shoulder  38 .  FIG. 10  illustrates the aspiration after piston  14 , here provided with sealing lips  40 , has been actuated to transfer the liquid into container  2 . By the application of vacuum, symbolically indicated by arrows  41 , piston  14  is retracted until the sealing lips reach enlarged area D 2 , thereby allowing the air contained in the containers to escape, which is a prerequisite for an optimally air-free, thorough mix of certain powders such as PMMA. Filter  37  may also be located in the vacuum coupling nozzle. 
       FIGS. 11 and 12  illustrate a device  42  where a third container  44  is arranged in enclosure  43  next to the two containers  2  and  3 . This third container  44  including piston  45  and thrust rod  46  may be designed like container  3  with a piston and thrust rod but may possibly have a different dimension, and it is filled with another liquid component  52 , e.g. with a hormone, with antibiotics or the like. 
     In the starting position of  FIG. 11 , outlet  48  for the mixture from containers  2  and  3  and outlet  49  of container  44  are sealed by a common closure  55  that interrupts the connection as long as the first liquid transferred to the powder is being admixed. For dispensing the second liquid and the mixture, the closure is removed and a mixer  30  or an accessory is attached to common outlet  47 . To this end, the usual bayonet coupling members in enclosure bottom  57  may be used. 
       FIG. 12  suggests that the liquid from container  3  has first been transferred to container  2  and subsequently the mixture from container  2  and the component from container  44  are dispensed through the common mixer. 
     Based on  FIGS. 11 and 12 , not only one but also further additional containers similar to container  44  can be arranged around container  2 , each comprising a respective closure of the outlets and a common coupling of the container outlet and of the outlet of container  2 . 
     In  FIGS. 13 to 18 , an appliance according to the invention is indicated that allows aspirating a liquid, e.g. blood, mixing it with a powder, and dispensing the mixture.  FIG. 13  shows a perspective view of appliance  60  including powder container  61 , marked “A”, for powder  71  and a liquid container  62 , marked “B”, for a liquid  72 . On the inlet side, mixing rod  65  with turning knob  66  and loose thrust rod  69  with thrust flange  74  as well as retaining flange  75  are visible. 
     Located on the outlet side is valve assembly  73  including fastening portion  76  with bayonet coupling members  77  and rotary ring  100  whose free end is provided with a handle portion  78  and near indicator disk  76 A of fastening portion  76  with a pointer  79 , pointer  79  indicating the current position of the three-way valve on indicator disk  76 A, for example A—B, connection between the two storage containers or A—O or B—O, connection between container A or container B and the inlet/outlet, or according to  FIG. 19  the closed position. For alignment during the attachment of the valve assembly, the fastening portion is provided with a nose  80 . 
     The valve assembly may be fastened in another manner than by bayonet coupling members, e.g. by means of a rotationally secure snap-on connection that may also be provided directly on the valve body. 
     Near the inlet, a piston  63  is arranged in powder container  61  through which mixing arrangement  64  with mixing rod  65 , turning knob  66  and mixing disk  67  passes. Liquid container  62  is provided near its inlet with a piston  68  that is displaceable toward outlet  70  by means of a separate, loose thrust rod  69 . 
     In the application of double syringe  60  as in the preceding examples, i.e. for transferring the liquid, mixing, and dispensing, between the illustrations of  FIG. 14  and  FIG. 15 , thrust rod  69  has been thrust in completely, liquid  72  has been transferred from liquid container  62  to powder container  61 , thrust rod  69  has been drawn off and then pushed in between piston  63  and the underside of turning knob  66  such that when pressing on the mixing rod, the latter actuates piston  63  via thrust rod  69  to dispense mixture  71 + 72 . To this end, the cross-section of the thrust rod may be a little more than semi-circular in shape so as to partially enclose the mixing rod and clamp it by its profile. 
     In the illustrations of  FIGS. 14 and 15 , valve assembly  73  has only been represented and described summarily in order to explain the operation of the loose thrust rod. The detailed description of valve assembly  73  follows with reference to  FIGS. 16-19 . 
     Dispensing appliance  60  according to  FIGS. 16 to 19  is primarily useful also for receiving a liquid such as e.g. blood in liquid container  62  and subsequently mixing it with the powder after its transfer to the powder container, and then dispensing it. To this end, the containers are connected to each other or to common inlet/outlet  101  via rotary ring  100 . 
     Also, the thrust rod and the piston end are so designed that the thrust rod can be coupled for retracting the piston by the thrust rod in order to aspirate a liquid. This coupling may e.g. be realized by providing an offset circular step having a slightly smaller diameter than the piston on the thrust rod side of the piston end, an internal groove at the piston side end of the slightly more than semicircular thrust rod being slidable thereon or releasable therefrom. 
     Valve assembly  73  in the form of a three-way valve is essentially composed of fastening portion  76 , a valve body  81  that is secured thereto, and a rotary ring  100 . Valve body  81  includes a coupling portion  106  that is insertable in the two container outlets  104  and  105  by coupling nozzles  102  and  103  and is followed on its outlet side by inlet/outlet portion  107 . Coupling portion  106  is maintained in a circular groove  115  of fastening portion  76  by means of a circular collar  114 . 
     Inlet/outlet portion  107  is provided with a bore  109  that is angled and ends at the periphery of the inlet/outlet portion. Analogously, inlets/outlets  110 ,  111  of coupling portion  106  of the valve body also end at the periphery, as appears most clearly in  FIG. 17 , and more specifically at the same height as the orifice of bore  109  in the inlet/outlet. Inlet/outlet portion  107  is surrounded by rotary ring  100 , which is retained on coupling portion  106  and extends beyond the peripheral entrances/exits of the inlets/outlets and is provided with an internal groove  112  that extends over a little more than a third of the circumference, as appears in sectional views A, B, C, D. 
     As appears when comparing  FIGS. 16 to 19  or A, B, C, and D, respectively, internal groove  112 , depending on the position of the rotary ring, either connects liquid container  62  to common inlet/outlet  101 ,  FIG. 16 , A, the two inlets/outlets  110  and  111  to each other,  FIG. 17 , B, or powder container  61  to common inlet/outlet  101 ,  FIG. 18 , C, or the rotary ring is in a closed position, D,  FIG. 19 , without a connection to any inlet or outlet. 
     In the position of  FIG. 16 , a liquid, e.g. blood can be aspirated by retracting piston  68 . In the position of  FIG. 17 , the rotary ring has been rotated by 120°, thereby connecting the two containers to each other and allowing the liquid to be transferred to the powder container. After a further rotation of the rotary ring by 60°, both containers are closed and the mixture can be mixed. Then the valve assembly is brought to the position of  FIG. 18 , thereby allowing the mixture in powder container  61  to be dispensed. It is also possible to aspirate another liquid into the liquid container, to transfer it to the powder container and to mix it subsequently. 
     Inlet/outlet  101  is in the form of a Luer connector having a thread  108  and allowing the connection either of another syringe or of an outlet attachment. However, it is also possible to disconnect the valve assembly by means of the bayonet coupling and to attach another connecting part, e.g. another Luer connector  31  of common use, see  FIG. 20 , by means of the bayonet connection. 
     Valve assembly  73  may alternatively be used for other devices than the described ones, e.g. in a general manner as a three-way valve with a rotary ring having a partial circular internal groove for connecting two container inlets/outlets either to each other or each to a common inlet/outlet, or closing all inlets/outlets. Again, in such an embodiment, the valve assembly may be fastened in another manner than by bayonet coupling members, e.g. by means of a rotationally secure snap-on connection that may also be provided directly on the valve body, i.e. without a fastening portion. 
     Other valve assemblies are also possible, e.g. an automatic valve assembly or a simple rotary or flat sealing rotary valve having a turning knob with a groove, which either establish or close a connection. 
       FIGS. 21-24  illustrate that instead of being made of one piece, the multicomponent syringes or cartridges may be manufactured and filled as separate storage containers that are joined prior to use and when required. 
       FIGS. 21 and 22  illustrate a powder container  82  and a liquid container  83 , the container of the larger cross-section, i.e. powder container  82 , comprising a retaining flange  84  whose part  85  that extends beyond container  82  serves for receiving the second container  83 . For this purpose, the projecting part  85  is provided with a circular bead  86  on its circumference. 
     On the outlet side, the larger container has an outlet flange  87  comprising the usual bayonet coupling means  88  as well as an opening  89  for receiving the outlet  90  of the smaller container. The described arrangement also applies to 1:1 containers. 
     Correspondingly, the same applies for a three-component syringe arrangement according to  FIGS. 23 and 24 . Powder container  91  comprises a retaining flange  92  having two projecting parts  93  and  94  that are each provided with circular beads  95  and  96  extending around parts  93  and  94  that serve for retaining liquid containers  83  and  97 , respectively. Outlet flange  98  comprises two bayonet coupling lugs  88 A and  88 B and a central double bayonet lug  88 D as well as two openings  89 A and  89 B for receiving outlets  90  and  99  of the respective liquid containers. The two bayonet couplings serve for connecting containers  91  and  83  or  91  and  97  that may either be provided with a valve assembly or an outlet attachment or a mixer. 
     In the illustrated exemplary embodiments, the outlet of the liquid container is inserted in opening  89 A or  89 B and the container is snapped in over bead  86  or  95 ,  96 . The connection and attachment of the individual containers forming a two-, three-, or multicomponent dispensing appliance may alternatively be achieved by other means, e.g. by means of snap-on connections or the like. Also, a double syringe or double cartridge may be connected to a further separate container in this manner.