Patent Publication Number: US-2018028401-A1

Title: Double-chamber infusion bag and production method therefor

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of International Patent Application No. PCT/CN2015/000405 with a filing date of Jun. 15, 2015, designating the United States, now pending, and further claims priority to Chinese Patent Application No. 201510167772.9 with a filing date of Apr. 10, 2015. The content of the aforementioned applications, including any intervening amendments thereto, are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present application relates to packing technology, particularly relates to medical sealed container, more particularly relates to a sealed container for infusion preparations, and specifically relates to a double-chambered infusion bag and method for producing the same. 
     BACKGROUND 
     In the pharmaceutical industry, it is often required to mix a solid powder medicament with a liquid medicament before being applied to an organism. The mixing operation of the medicaments should be performed under aseptic condition. In order to improve the efficiency and convenience in the mixing operation of the medicaments, a soft infusion bag having two independent chambers was proposed in the prior art, the soft infusion bag has a first chamber, a second chamber, and an output tube. The first chamber is accommodated with the liquid medicament, the second chamber is accommodated with the powder medicament, and the first chamber is separated from the second chamber by a peelable strip pseudo soldering structure arranged between a front bag film and a rear bag film of the soft infusion bag. The peelable strip pseudo soldering structure may be peeled under an increased pressure in the first chamber generated by pressing the bag body at the first chamber, so that the liquid medicament enters the second chamber to realize the mixing operation. Since the output tube is arranged at one side of the first chamber and is always located at a lower end of the soft infusion bag during infusion, while the powder medicament is accommodated inside the second chamber at an upper part of the soft infusion bag, it often occurs that the powder medicament remains in the second chamber and cannot be completely mixed with the liquid medicament, which results in inaccurate dose and waste of the medicaments. In addition, such type of design also easily results in misoperation that the infusion is directly conducted without opening the peelable pseudo soldering structure to allow the solid medicament to be mixed with the liquid medicament, which does not have the treating efficacy. 
     SUMMARY 
     It is an object of the invention to provide a double-chambered infusion bag, and this kind of double-chambered infusion bag aims at, among others, solving the technical problem that in the prior art, the similar infusion bags have power medicament residue, and cannot be, or cannot be completely, mixed with the liquid medicament. 
     A double-chambered infusion bag of the present application comprises a sealed soft infusion bag, the soft infusion bag comprising a piece of a front bag film, a piece of a rear bag film, and an output tube. The front bag film and the rear bag film are both rectangular, the front bag film and the rear bag film are permanently connected at peripheries thereof by a permanent soldered structure, the front bag film and the rear bag film are provided therebetween with a first chamber and a second chamber, the first chamber and the second chamber are arranged from the top downward along a lengthwise direction of the soft infusion bag, the first chamber and the second chamber are separated by a first peelable strip pseudo soldering structure arranged between the front bag film and the second bag film, the first chamber is accommodated with a liquid medicament, the second chamber is accommodated with a powder medicament, the output tube is arranged at a lower end of the soft infusion bag, the output tube is separated from the second chamber via a second peelable strip pseudo soldering structure arranged between the front bag film and the rear bag film, a breakthrough pressure of the second peelable strip pseudo soldering structure is equal to or greater than a breakthrough pressure of the first peelable strip pseudo soldering structure; and a striated structure is defined on a surface of the front bag film facing the rear bag film, or, a striated structure is defined on a surface of the rear bag film facing the front bag film, or, striated structures are respectively defined on a surface of the front bag film and a surface of the rear bag film that face each other. 
     Further, a periphery of the output tube is permanently connected with the front bag film and the rear bag film via the permanent soldered structure. 
     Further, a width of the second chamber is smaller than a width of the first chamber. 
     Further, outer peripheries of the front bag film and the rear bag film of the second chamber are permanently connected with compound aluminum films or transparent or semi-transparent compound films with barrier properties having silica or alumina plating layers, and the permanent connection of at least one outer side is able to be peeled under a certain external force. 
     The present application further provides a method for producing the double-chambered infusion bag, and the method comprises a process of soldering the front bag film and the rear bag film, in which, during the process of soldering the front bag film and the rear bag film, the front bag film and the rear bag film are permanently connected at peripheries thereof by the permanent soldered structure to form the soft infusion bag, at least one first peelable strip pseudo soldering structure and at least one second peelable strip pseudo soldering structure are processed between the front bag film and the rear bag film to form the first chamber and the second first chamber from the top downward, meanwhile, the output tube is fixed at the lower end of the soft infusion bag, and the second peelable strip pseudo soldering structure is used to separate an upper end of the output tube from the second chamber, after the front bag film and the rear film are soldered, the liquid medicament is filled into the first chamber and the first chamber is sealed; the soft infusion bag and the output tube are then sterilized and dried; thereafter, one side of the soft infusion bag is cut to form a second channel at one side of the second chamber, the power medicament is filled into the second chamber via the second channel; and the second channel is sealed after the filling of the powder medicament. 
     Further, in the step of permanent connection of the front bag film and the rear bag film at the peripheries thereof via the permanent soldered structure, a first channel for introducing the liquid medicament is reserved at an upper end of the front bag film and an upper end of the rear bag film. 
     Further, after the filling of the power medicament and the sealing of the second channel, outer sides of the soft infusion bag are permanently connected with compound aluminum films or transparent or semi-transparent compound films with barrier properties having silica or alumina plating layers, and the permanent connection of at least one outer side is able to be peeled under a certain external force. 
     Further, a periphery of the soft infusion bag is performed with punching modification. 
     Working principle of the present application is as follows: the first chamber is separated from the second chamber via the first peelable strip pseudo soldering structure. In use, the soft infusion bag is squeezed to allow the liquid medicament in the first chamber to pierce the first peelable strip pseudo soldering structure to enter the second chamber where the liquid medicament is mixed with the powder medicament, the squeeze of the soft infusion bag is continued, mixed medicaments in the first chamber and the second chamber pierce the second peelable strip pseudo soldering structure to enter the output tube, and are then output via an infusion tube that is inserted into the output tube. 
     Compared with the prior art, effects of the present application is positive and obvious. The present application arranges the second chamber accommodating the powder medicament between the first chamber accommodating the liquid medicament and the output tube for outputting the medicaments, thus ensuring the complete mixing of the powder medicament and the liquid medicament. The breakthrough pressure of the peelable strip pseudo soldering structure that is adjacent to the liquid medicament accommodated chamber is smaller than or equal to the breakthrough pressure of the peelable strip pseudo soldering structure that is adjacent to the output tube, thus ensuring that the powder medicament is mixed with the liquid medicament in advance before entering the output tube. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a structural schematic diagram of a double-chambered infusion bag; 
         FIG. 2  is a schematic diagram of a step of bag fabrication in a process for preparing the double-chambered infusion bag; 
         FIG. 3  is a schematic diagram of a step of filling of a liquid medicament in the process for preparing the double-chambered infusion bag; 
         FIG. 4  is a schematic diagram of a step of sterilization in the process for preparing the double-chambered infusion bag; 
         FIG. 5  is a schematic diagram of a step of cutting of one side of the second chamber in the process for preparing the double-chambered infusion bag; 
         FIG. 6  is a schematic diagram of a step of filling of a powder medicament in the process for preparing the double-chambered infusion bag; 
         FIG. 7  is a schematic diagram of a step of attaching of aluminum films in the process for preparing the double-chambered infusion bag; 
         FIG. 8  is a schematic diagram of a step of punching modification in the process for preparing the double-chambered infusion bag; 
         FIGS. 9 a -9 c    are structural schematic diagrams showing front and rear bag films for preparing the double-chambered infusion bag; 
         FIGS. 10 a  and 10 b    are structural schematic diagrams of a striated structure. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     Example 1 
     As shown in  FIGS. 1 and 9   a , a double-chambered infusion bag of the present application comprises a sealed soft infusion bag  1 . The soft infusion bag  1  comprises a piece of a front bag film  3 , a piece of a rear bag film  4 , and an output tube  2 . The front bag film  3  and the rear bag film  4  are both rectangular. The front bag film  3  and the rear bag film  4  are permanently connected at peripheries thereof by a permanent soldered structure. The front bag film  3  and the rear bag film  4  are provided therebetween with a first chamber  11  and a second chamber  12 . The first chamber  11  and the second chamber  12  are arranged from the top downward along a lengthwise direction of the soft infusion bag  1 , in which, the first chamber  11  and the second chamber  12  are separated by a first peelable strip pseudo soldering structure  13  that are arranged between the front bag film  3  and the rear bag film  4 . The first chamber  11  is accommodated with a liquid medicament  15 , and the second chamber  12  is accommodated with a powder medicament  16 . The output tube  2  is arranged at a lower end of the soft infusion bag  1 . The output tube  2  is separated from the second chamber  12  via a second peelable strip pseudo soldering structure  14  arranged between the front bag film  3  and the rear bag film  4 . A breakthrough pressure of the second peelable strip pseudo soldering structure  14  is equal to or greater than a breakthrough pressure of the first peelable strip pseudo soldering structure  13 , and a width of the second chamber  12  is smaller than a width of the first chamber  11 . 
     Further, as shown in  FIGS. 9 a -9 c , 10 a  and 10 b   , a striated structure  5  is defined on a surface of the front bag film  3  facing the rear bag film  4 , or, a striated structure  5  is defined on a surface of the rear bag film  4  facing the front bag film  3 , or, striated structures  5  are respectively defined on a surface of the front bag film  3  and a surface of the rear bag film  4  that face each other. With the striated structure  5 , a sterilization process of 121° C. can be adopted to produce the double-chambered infusion bag. The striated structure  5  is capable of preventing the front and rear bag films  3  and  4  from adhering to each other when performing sterilization under 121° C. At the same time, steam will enter into the cavity of the striated structure  5  when performing sterilization under 121° C. so as to perform moist-heat sterilization in the infusion bag. The sterilization process of 121° C. is the most economical and safe process for producing the double-chambered infusion bag. Without the striated structure  5 , it can adopt a sterilization process of 107° C. However, the sterilization effect is also watered-down and more time is needed for sterilization which will directly affect production efficiency. Alternatively, without the striated structure  5 , a ray sterilization process may be adopted. However, this sterilization process is expensive and will bring a risk of exposure to radiation to operators. 
     Further, a periphery of the output tube  2  is permanently connected with the front bag film and the rear bag film via the permanent soldered structure. 
     Further, outer peripheries of the front bag film and the rear bag film of the second chamber are permanently connected with compound aluminum films or transparent or semi-transparent compound films  17  with barrier properties having silica (SiO2) or alumina (Al2O3) plating layers, and the permanent connection of at least one outer side is able to be peeled under a certain external force. 
     A method for producing the above double-chambered infusion bag, the method comprises a process of soldering the front bag film and the rear bag film, in which, as shown in  FIG. 2 , during the process of soldering the front bag film and the rear bag film, the front bag film and the rear bag film are permanently connected at peripheries thereof by the permanent soldered structure to form the soft infusion bag  1 , the a first peelable strip pseudo soldering structure  13  and the at least one second peelable strip pseudo soldering structure  14  are processed between the front bag film and the rear bag film to form the first chamber  11  and the second first chamber  12  from the top downward, meanwhile, the output tube  2  is fixed at the lower end of the soft infusion bag  1 , and the second peelable strip pseudo soldering structure  14  is used to separate an upper end of the output tube  2  from the second chamber  12 . As shown in  FIG. 3 , after the front bag film and the rear film are soldered, the liquid medicament is filled into the first chamber  11  and the first chamber  11  is then sealed. As shown in  FIG. 4 , the soft infusion bag  1  and the output tube  2  are then sterilized and dried. As shown in  FIG. 5 , thereafter, one side of the soft infusion bag  1  is cut to form a second channel at one side of the second chamber  12 , the power medicament  16  is filled into the second chamber  12  via the second channel, as shown in  FIG. 6 , the second channel is sealed after the filling of the powder medicament  16 . 
     Further, in the step of permanent connection of the front bag film and the rear bag film at the peripheries thereof via the permanent soldered structure, a first channel for introducing the liquid medicament is reserved at an upper end of the front bag film and an upper end of the rear bag film. 
     As shown in  FIG. 7 , further, after the filling of the power medicament  16  and the sealing of the second channel, outer sides of the soft infusion bag  1  are attached with aluminum films  17 . 
     As shown in  FIG. 8 , further, a periphery of the soft infusion bag  1  is performed with punching modification. 
     Working principle of the present example is as follows: the first chamber  11  is separated from the second chamber  12  via the first peelable strip pseudo soldering structure  13 . In use, the soft infusion bag  1  is squeezed to allow the liquid medicament  15  in the first chamber  11  to pierce the first peelable strip pseudo soldering structure  13  to enter the second chamber  12  where the liquid medicament  15  is mixed with the powder medicament  16 , the squeeze of the soft infusion bag  1  is continued, mixed medicaments in the first chamber  11  and the second chamber  12  pierce the second peelable strip pseudo soldering structure  14  to enter the output tube  2 , and are then output via an infusion tube that is inserted into the output tube  2 .