Patent Abstract:
A multi-compartment syringe apparatus ( 500 ) for in-situ mixing of a plurality of products before use, the apparatus comprising: a tube; a hollowed flexible plunger ( 530 ); a one way filter piston ( 514 ), connected to the plunger ( 530 ), the piston confining a first compartment ( 502 ) at a side of a needle ( 540 ) of the apparatus, and a second compartment ( 510 ) at a side of the plunger, wherein the filter allowing passage of content only form the first compartment to the second compartment ( 510 ); a first product ( 506 ), stored in the first compartment ( 502 ); a second product ( 508 ), stored in a first breakable container ( 504 ) disposed in the plunger ( 530 ); thereby the second product ( 508 ) mixes with the first product ( 506 ); and the mixed products are then pushed out of the apparatus, through the needle ( 540 ).

Full Description:
FIELD OF THE INVENTION 
     The present invention relates generally to container apparatus and methods, and more specifically to methods and apparatus for in situ mixing of components prior to use. 
     BACKGROUND OF THE INVENTION 
     It is often desirable or necessary to store two or more components of a product separately and to mix the components shortly before use or application. In some cases, the components may react together and thus need to be stored separately, prior to use. In some cases, these components may be of a medical preparation, a food or beverage, a chemical product, a building product or the like. 
     In the medical field, it is also particularly desirable to mix components in single use batches, to assure consistency in the delivery of the combined components. Compositions comprising at least two of anesthetics, pain killers, antibiotics and antiseptics need to be mixed quickly in emergency medicine, for example. Orthopedic mixtures such as bone fillers and bone cements need to be mixed immediately before use, as do medical adhesives, dental adhesives and the like. 
     There is therefore a need to provide apparatus and methods to perform in-situ mixing of two or more components in a hygienic, sterile manner, prior to application to a patient. Likewise, many other food/beverage/chemical mixtures need to be mixed in such apparatus prior to use. 
     The storage and mixing apparatus should preferably store the components separately prior to mixing. Thereafter, using a simple mechanism, mixing should be relatively quick, and the apparatus should be relatively cheap. 
     Several prior art patent publications in the field include: 
     US Patent Application Publication No. US2003222102 describes a cap device for bottles, which is capable of mixing an additive contained therein with a material contained in a bottle to prepare a mixture in accordance with a simple rotating action of the cap device relative to the bottle, performed by a user, thus allowing the user to easily prepare the mixture just before taking or using the mixture. The cap device has a cap body tightened to an externally threaded mouth of the bottle, with a funnel part integrally formed in the cap body to discharge the additive from the cap body into the bottle through a lower end thereof. A cap cover is assembled with the cap body to cover an open upper end of the cap body while defining a cavity inside both the cap body and the cap cover to contain the additive in the cavity. The cap device also has a valve means for opening or closing the lower end of the funnel part of the cap body in accordance with the rotating action of the cap body relative to the externally threaded mouth of the bottle. 
     U.S. Pat. No. 5,743,312 describes an apparatus for combining liquid or solid components stored in containers includes a cylindrical hollow body for receiving end closures of the containers and at least one cannula for penetrating the end closures. The cannula is mounted in a cannula holder movable in the hollow body, and retainer bridges connect the cannula holder to an inner wall surface of the hollow body. The retainer bridges fracture after the cannula penetrates the end closure in the first container so that the cannula moves toward the second container to penetrate the closure in the second container. Also disclosed is a system including the apparatus, two containers, and outer packaging enclosing the containers and the hollow body. 
     U.S. Pat. No. 7,018,089 discloses a double syringe apparatus and method for mixing two components. 
     US Patent Application Publication No. US2009180923A relates to a self-mixing container with a releasable internal vessel and its usage, wherein said self-mixing container comprises a container body, a double-walled external cap and an internal vessel, and through a corresponding production line, assembling of the self-mixing container with a releasable internal vessel will be realized. The invention makes it possible to pack and seal in a cold filling process at least two different materials in one and the same container body respectively. When in use, at least two kinds of materials are mixed and formulated in one and the same container body in a rapid and automatic way, by means of relative movement of the screw-threads by which the container body, the double-walled external cap and the internal vessel are coupled with each other, and engagement of the ratchet and the pawls, without the structure of the container body being damaged, so that initial fresh active components in the materials sealed therein are preserved, and rapid formulation is achieved. Furthermore, the structure is simple, durable and has a low fabrication cost, and it can be used without great effort or time, especially can be used conveniently when carried on, and it can be broadly applied to pharmaceutical, food and beverage, chemical, farm chemical, disinfectants, or fire-fighting equipments field. 
     US Patent Application Publication No. US2010034574 describes a dispensing device, including inner and outer compartments for housing two different cosmetic liquid materials therein, the outer compartment secured to a cap by threading; a spring biased valve for blocking both openings of the inner and outer compartments when the device is in an inoperative position; and an outlet assembly partially fastened in the valve. An individual may unfasten and remove the cap from the device to unblock the valve, and squeeze both the outer and the inner compartments to push the cosmetic liquid materials to mix in the outlet assembly prior to dispensing out of the device. 
     It is therefore still desirable to provide improved storage and mixing apparatus, which are relatively inexpensive to produce, yet should provide complete and reliable isolation of the components to be mixed prior to use. The apparatus should be suitable for both liquid-powder and liquid-liquid mixes and should be relatively simple to use. The apparatus should further provide precise and accurate delivery of the mixed compositions. At least some of these objectives will be met by the inventions described herein below. 
     SUMMARY OF THE INVENTION 
     It is an object of some aspects of the present invention to provide storage and mixing apparatus for in-situ mixing of at least two components prior to use of a resultant mixture. 
     In some embodiments of the present invention, improved methods and apparatus are provided for in-situ mixing of at least two components prior to use of a resultant mixture. 
     In other embodiments of the present invention, a method and system is described for providing a syringe apparatus and method for in-situ mixing of at least two components prior to use of a resultant mixture. 
     There is thus provided according to an embodiment of the present invention, a multi-compartment apparatus for in-situ mixing of a plurality of components before use, the apparatus including;
         a. an outer container including a first product;   b. an inner container including a second product, wherein the inner container is adapted to release the second product into the first product thereby forming a mixture; and   c. an openable aperture portion, in fluid communication with the outer container, typically including a filter, adapted to filter the mixture prior to release via the aperture.       

     According to some embodiments of the present invention, the first product is a first liquid. 
     Furthermore, according to some embodiments of the present invention, the inner container is disposed in the first liquid. 
     Additionally, according to some embodiments of the present invention, the second product includes a second liquid. 
     According to some additional embodiments of the present invention, the outer container includes at least one flexible portion. 
     According to some yet further embodiments of the present invention, the at least one flexible portion may be manipulated so as to break the inner container to release the second product into the first liquid thereby forming the mixture. 
     Furthermore, according to some embodiments of the present invention, the apparatus is a syringe. 
     According to some additional embodiments of the present invention, the openable aperture further includes a removable lid. 
     Additionally, according to some embodiments of the present invention, upon removal of the removable lid, the filtered mixture is adapted to be released from the apparatus. 
     Additionally, according to some embodiments of the present invention, the multi-compartment apparatus further includes a second inner containing adapted to house a third product. The third product may be a liquid or flowable solid. 
     There is thus provided according to another embodiment of the present invention, a method for multi-product storage and mixing in-situ before use, the method including;
         a. providing a first and second product in the apparatus as described herein;   b. releasing the second product into the first product thereby forming a mixture; and optionally,   c. filtering the mixture to form a filtrate; and   d. applying at least one of the filtrate and the mixture to a destination site.       

     Additionally, according to some embodiments of the present invention, the filtrate is a medical product. 
     There is thus provided according to another embodiment of the present invention, a multi-compartment kit for in-situ mixing of a plurality of components before use, the kit including;
         a) an apparatus as described herein; and   b) instructions on how to use the apparatus.       

     The present invention will be more fully understood from the following detailed description of the preferred embodiments thereof, taken together with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will now be described in connection with certain preferred embodiments with reference to the following illustrative figures so that it may be more fully understood. 
       With specific reference now to the figures in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. 
       In the drawings: 
         FIG. 1  is a simplified pictorial illustration of a multi-compartment apparatus for in-situ mixing of a plurality of components before use, in accordance with an embodiment of the present invention; 
         FIG. 2  is a simplified flow chart of a method for in-situ mixing of a plurality of components using the apparatus of  FIG. 1 , in accordance with an embodiment of the present invention; 
         FIG. 3  is a simplified pictorial illustration of another multi-compartment apparatus, in accordance with an embodiment of the present invention; 
         FIG. 4  is a simplified pictorial illustration of another multi-compartment apparatus, in accordance with an embodiment of the present invention; 
         FIG. 5  is a simplified pictorial illustration of a multi-compartment syringe apparatus, in accordance with an embodiment of the present invention; 
         FIG. 6  is a simplified flow chart of a method for in-situ mixing of a plurality of components using the apparatus of  FIG. 5 , in accordance with an embodiment of the present invention; 
         FIG. 7  is a simplified pictorial illustration of another multi-compartment apparatus, in accordance with an embodiment of the present invention; 
         FIG. 8  is a simplified flow chart of a method for in-situ mixing of a plurality of components using the apparatus of  FIG. 7 , in accordance with an embodiment of the present invention; and 
         FIG. 9  is a simplified pictorial illustration of another multi-compartment apparatus, in accordance with an embodiment of the present invention. 
     
    
    
     In all the figures similar reference numerals identify similar parts. 
     DETAILED DESCRIPTION OF THE INVENTION 
     In the detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that these are specific embodiments and that the present invention may be practiced also in different ways that embody the characterizing features of the invention as described and claimed herein. 
     Reference is now made to  FIG. 1 , which is a simplified pictorial illustration of a multi-compartment apparatus  100  for in-situ mixing of a plurality of components before use, shown in three different positions A, B and C, respectively in accordance with an embodiment of the present invention. 
     Apparatus  100  comprises an external container  102 , made, at least in some parts of a deformable material and contains a first liquid  106 . An internal container  104  is disposed in the first liquid. The internal container comprises a second liquid  108 . External container  102  typically comprises air  110  in an air portion  118 . The apparatus comprises an upper portion  112  above the air portion. The upper portion comprises a filter, which allows passage of liquids from the air portion to an aperture  119 , but does not allow solids to exit at aperture  119  after lid/screw cap  116  has been removed. 
     According to some embodiments, apparatus  100  has a flexible region  117  of made of more flexible material than the other regions  115 . 
     According to some embodiments, regions  115  and region  117  are made of the same material of the same thickness. The material may be suitable formulations of polyethylene, polyurethane, polypropylene, polyamide or combinations thereof. According to one embodiment, the external container is made of a clear molded plastic. In some cases, coloring components or dyes will be added to the material of the outer container, if the first and/or second liquid is light sensitive, by methods well known in the art. 
     According to some embodiments, regions  115  and region  117  are made of the same material, but the flexible region is of a lesser thickness. 
     According to some embodiments, external container  102  is made of a deformable polymeric material, such as a plastic polymer or polymer blend. 
     As is seen in  FIG. 1B , external container  102  may be bent over by pressing on two other regions  115  thereby breaking internal container  104 , which is made of a stiffer, less flexible material than the external container, thereby breaking internal container  104  into pieces and releasing second liquid  108  into first liquid  106  thereby forming a mixture  130  ( FIG. 1C ). According to one embodiment, the internal container may be a sealed frangible glass vial. According to some further embodiments, the internal container may be made of a material, which may be glass, a glass substitute, a fragile or rigid polymer, a polymer blend or combinations thereof. 
     Alternatively, the user can press on a flexible region and break the internal container. 
     Reference is now made to  FIG. 2 , which is a simplified flow chart  200  of a method for in-situ mixing of a plurality of components using the apparatus of  FIG. 1 , in accordance with an embodiment of the present invention. 
     In a first breaking step  202 , the user breaks the inner container (or ampoule) by deforming the outer container from the upper and lower portions  115  or by pressing in on flexible portion  117 . 
     In a mixing step, as shown in  FIG. 1B , inner container  104  is broken into pieces  120  and thereby releases second liquid  108  into first liquid  106  thereby forming a first mixture  130 . The user may additionally shake the apparatus to ensure enhanced mixing. 
     In an opening step  206 , the user opens lid  116  (which may be a screw cap, cork, bung, lid or any other suitable lid). 
     In an application step  208 , the mixture passes through filter  114  to ensure that no pieces  120  exit from aperture  119 . The liquid mixture is then applied to the target site. This may be an external body site, a piece of furniture, it may be eaten/drunk if appropriate, or applied to the required destination site. It should be understood that the mixture may be a suspension, a liquid-gas fluid or any other liquid-like mixture. 
     Reference is now made to  FIG. 3 , which is a simplified pictorial illustration of another multi-compartment apparatus  300 , in accordance with an embodiment of the present invention. Apparatus  300  comprises a netting  326  or filter disposed within an outer container  302 . The netting  326  or filter is suitably disposed adjacent to an upper portion  312  of the apparatus to ensure adequate catching of pieces  120  formed upon breaking of inner container  304 , in addition to a filter  314  disposed in the upper portion  312 . 
     As was shown in  FIG. 1A , in apparatus  100 , the inner container was not attached to any part of the outer container. In contrast, in  FIG. 4 , there is seen a simplified pictorial illustration of another multi-compartment apparatus  400 , in accordance with an embodiment of the present invention. 
     Apparatus  400  comprises attaching means  410  for affixing an inner container  404 , comprising a second liquid  408 , inside an outer container  402  containing a first liquid  406 . The attaching means is constructed and configured to prevent the breakage of the inner container before its intended use. 
     Reference is now made to  FIG. 5 , which is a simplified pictorial illustration of a multi-compartment syringe apparatus  100 , in accordance with an embodiment of the present invention. 
     Multi-compartment syringe apparatus  500  is constructed and configured to enable hygienic and preferably sterile, in-situ mixing of a plurality of components before use. 
     According to some embodiments, apparatus  500  is for medical use for providing a medicament mixture comprising a first liquid  506  and a second liquid  508  after forming the mixture. 
     Multi-compartment syringe apparatus  500  comprises a plunger  530  housing a second container  504  (similar or identical to internal container  104  of  FIG. 1 , which contains a second liquid  508 . The plunger comprises a handle section  532 , an upper section  534  and a lower section  536 . Plunger  530  is made of a similar or identical material to external container  102  ( FIG. 1 ) and may also have flexible portions therein (not shown). 
     Multi-compartment syringe apparatus  500  further comprises a plunger receiving section  510 , made out of a material similar or identical to external container  102  ( FIG. 1 ), which comprises air  512 , a filter  514  disposed below the air and above a first container  502  housing a first liquid  506 . The multi-compartment syringe apparatus  500  further comprises a conical section  542  and hollow needle portion  540 . Section  510  is not sealed, thereby allowing air  512  to penetrate in and out of section  510 , depending on the situation of piston/filter  514 . Filter/piston  514  is connected to plunger  530 . The filter allows liquid passage only from first container  502  into plunger receiving section  510 . 
     It should be noted that the surface of second container  504  is unfolded, thereby upon breaking the container, its entire content (second product) is mixed with the first product. 
     Reference is now made to  FIG. 6 , which is a simplified flow chart  600  of a method for in-situ mixing of a plurality of components, prior to application using the apparatus of  FIG. 5 , in accordance with an embodiment of the present invention. 
     In a breaking step  602 , scheme (A) in  FIG. 5 , the user breaks the inner container  504  (or ampoule) by deforming the plunger  530  such as by pressing in on flexible portion  517 . This releases the second liquid  508  into the plunger. The result of this operation is illustrated in scheme (B) in  FIG. 5 . Reference numeral  508 ′ denotes the spilled content  508  of container  504 . Reference numeral  504 ′ denotes the broken inner container. 
     In an inserting step  604 , while holding syringe apparatus  500  vertically such that needle  540  turns down, the plunger is pulled out and thereby forcing the second liquid  508 ′ to pass through the filter into first container  502 , yet retaining any pieces of the broken ampoule within the plunger. 
     In a mixing step  606 , the second liquid that has been received in first container  502  is mixed with a first liquid  506  forming a mixture ( 507  in  FIG. 5 ). 
     In an injecting step  608  (scheme (D) in  FIG. 5 ), the mixture is injected from the first container via the conical section and needle into the patient. 
     Alternatively, the mixture may be applied via needle  540  to any other suitable destination site. 
     Reference is now made to  FIG. 7 , which is a simplified pictorial illustration of another multi-compartment apparatus  700 , in accordance with an embodiment of the present invention. 
     Apparatus  700  houses a solid particulate product  760  within a lower section  780 . The solid particulate matter is kept dry and separate from a first liquid  706  by means of a membrane  750 . The first liquid is contained within a first container  702  above the lower section of the apparatus. The first container may be constructed of a material similar or identical to first container  102  of  FIG. 1 . The apparatus also comprises a lid  716 , a filter  714  disposed in an upper portion  712  thereof. 
     The apparatus may also comprise an air portion  790  comprising air  710 . 
     A second container  704  is suspended in the first liquid. The second container comprises a second liquid  708  and a sharp pointed end section  770 . 
       FIG. 8  is a simplified flow chart  800  of a method for in-situ mixing of a plurality of components using the apparatus of  FIG. 7 , in accordance with an embodiment of the present invention. 
     In a membrane breaking step  802 , the user pushed pointed end section into membrane  750  by, for example, pressing on the flexible section or by squeezing the first container. 
     Once the membrane is broken, the particulate powder product  760  is released into the first liquid, thereby forming a first mixture (not shown). This first mixing step  804  may additionally require shaking of the apparatus, in some cases. 
     In a second optional breaking step  806 , the user breaks the second container  704  by, for example pressing on the flexible regions or bending the first container. 
     In a second mixing step  808 , the second liquid and first mixture are mixed by diffusion and/or by shaking thereby forming a second mixture. 
     In a mixture application step  810 , the lid is removed and the first or second mixture (depending on the previous steps) is filtered via filter  714  upon release to a destination site or container or person. 
     According to one embodiment, the first liquid is water, the second liquid is milk and the particulate powder is a drink powder, such as frieze-dried coffee or tea and/or sugar and/or artificial sweetener. The second mixture is thus for example, a cold coffee drink. It should be understood that the apparatus may be heated by microwave to supply a hot drink. 
     Reference is now made to  FIG. 9 , which is a simplified pictorial illustration of a multi-compartment apparatus  900  for housing three liquids, in accordance with an embodiment of the present invention. 
     Apparatus  900  comprises a lid  916  (and filter (not shown)) a first container  902  containing a first fluid  906 . Container  902  comprises two sections  920  and  930  with a narrow connecting element  970  enabling fluid connection between the two sections  920 ,  930 . Section  920  comprises first ampoule  904  containing a second liquid  908 . 
     Section  930  comprises a second ampoule  960  containing a third liquid  962 . Ampoules  960  and  904  may be broken to release the third and second liquid into the first liquid. 
     Alternatively, one or more of the ampoules may contain a powder or gel or suspension. Thus, various mixtures may be made in-situ, prior to application to one or more destination sites. 
     The following examples are meant to provide exemplary illustrations of the present invention, which are not intended to be limiting. 
     EXAMPLES 
     Example 1 
     In emergency care, it is often necessary to provide a painkiller and at least one of a) an antibiotic; b) a drug and a c) vaccine. The painkillers, antibiotics, drugs and vaccines are nearly always stored separately. For example, a paramedic may need to provide a painkiller, such as lidocaine and an anti-tetanus vaccine, which can be painful. Rather than inject the patient twice, he can use the multi-compartment syringe apparatus  500  of  FIG. 5  hereinabove and the method of  FIG. 6 , in which the lidocaine preparation is second liquid  508  and the anti-tetanus vaccine is first liquid  506 . 
     The dosages used will be in accordance to the patient&#39;s weight, age, gender as is current practice by medical practitioners in the art. 
     The patient can thus be vaccinated and provided with a painkiller in the form of a mixture simultaneously. 
     Example 2 
     In emergency care, it is often necessary to provide a painkiller and at least one of a) an antibiotic; b) a drug and a c) vaccine. The painkillers, antibiotics, drugs and vaccines are nearly always stored separately. For example, a paramedic may need to provide a painkiller, such as lidocaine and an anti-coagulant, such as heparin. Rather than inject the patient twice, he can use the multi-compartment syringe apparatus  500  of  FIG. 5  hereinabove and the method of  FIG. 6 , in which the lidocaine preparation is second liquid  508  and the heparin solution is first liquid  506 . 
     In many other examples for medical applications, the user can use apparatus  100  of  FIG. 1  comprising one medical component in the inner compartment  104  and a second medical component in the outer compartment  102 . It should be further understood that the apparatus shown in  FIGS. 3 ,  5 ,  7  and  9  may all be used and applied to various different medical applications. 
     The patient can thus be provided with an anti-coagulant and provided with a painkiller in the form of a mixture simultaneously. The dosages used will be in accordance to the patient&#39;s weight, age, gender as is current practice by medical practitioners in the art. 
     Many other examples in the medical field are apparent to a person skilled in the art and the example is not meant to be limiting. 
     Example 3 
     Various glues and adhesives are provided in two separate tubes, such as Epoxy or polyepoxide, which is a thermosetting polymer formed from reaction of an epoxide “resin” with polyamine “hardener”. Epoxy has a wide range of applications, including fiber-reinforced plastic materials and general purpose adhesives. Apparatus  100  may be used to house an epoxy  106  and the polyamine  108  may be housed in an inner ampoule  104 . Using the method of  FIG. 2 , the mixed epoxy may be applied to a target site, such as for bonding two pieces of metal. 
     Example 4 
     Apparatus  700  in  FIG. 7  may be used to prepare coffee. According to one embodiment, the first liquid  706  is water, the second liquid  708  is milk and the particulate powder  760  is a drink powder, such as frieze-dried coffee or tea and/or sugar and/or artificial sweetener. The second mixture, produced using the method of  FIG. 8  is thus for example, a cold coffee drink. It should be understood that the apparatus may be heated by microwave to supply a hot drink. 
     Example 5 
     A sportsperson may wish to drink during his/her sporting activity, such as cycling, swimming and the like. He may use the apparatus of the present invention, such as, but not limited to apparatus  100  as shown in  FIG. 1 . The apparatus may be a flexible or non-flexible bottle of any suitable size, such as 300 ml, 500 ml 1 liter and 1.5 liter. The outer compartment may comprise an energy gel, such as GU Energy Gel and the inner compartment an isotonic drink such as, but limited to GATORADE. 
     Example 6 
     The apparatus of the present invention shown in the figures may be used for keeping two or more beverage components stored separately, which can be mixed shortly before drinking For example, an alcoholic beverage such as Bacardi with coca cola, or vodka with energy drinks, or other kinds of cocktails. These are stored separately before use. 
     There are drinks without alcohol that usually contains more than one component. For example, one may wish to store soda water and tomato juice separately and mix them before use. Numerous other examples of multi-component drinks mixes may be stored separately using the apparatus of the present invention, and can then be hygienically prepared before use. 
     This example applies to a person who goes on a trip or on a nature hike or trek and wants to take with him his favorite drink. Applying the apparatus and methods of the present invention, this may be performed easily, whether the apparatus is made of glass, plastic or any other suitable material. 
     The references cited herein teach many principles that are applicable to the present invention. Therefore the full contents of these publications are incorporated by reference herein where appropriate for teachings of additional or alternative details, features and/or technical background. 
     It is to be understood that the invention is not limited in its application to the details set forth in the description contained herein or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Those skilled in the art will readily appreciate that various modifications and changes can be applied to the embodiments of the invention as hereinbefore described without departing from its scope, defined in and by the appended claims.

Technology Classification (CPC): 0