Patent Publication Number: US-7896860-B2

Title: Transportation device of medicine

Description:
TECHNICAL FIELD 
     The present invention relates to a transportation device of a medicine, which is suitable for a medical operation, such as an addition of a medicine (co-infusion) to a medical bag, such as a dripping bag during an execution of an infusion operation. 
     BACKGROUND TECHNOLOGY 
     When an infusion operation such as a dripping infusion is done from a medical bag (first medical storage) for storing therein with medicines (first medicines) such as a liquid glucose and physiological saline, et al, a situation may occur that an addition (co-infusion) of different medicines (second medicines) such as vitamins to the medical bag is needed. Such a medical bag for infusion is formed as a bag from a flexible plastic film such as polyethylene, the medical bag having a sealed structure of an outlet port, which is provided with a plug made of an elastic material such as a rubber (first rubber plug). A co-infusion container (second medical storage) for storing therein with medicines for co-infusing operation with the medical bag is formed as a rigid plastic mold body and is provided with a rubber plug (second rubber plug) for sealing an injection port (co-infusion port) of a needle shape. Under un-wrapped condition of the second rubber plug, the needle shaped injection port of the second medical storage pierces the first rubber plug, which causes the medicine(s) in second medical storage medicine to be introduced into the first medical storage for obtaining co-infusion operation. As a system of such a principle of transportation, a relatively movable structure of a body (cylindrical portion) of a needle shaped injection port of the second medical storage (co-infusion container) is proposed. In this structure, when the needle shaped injection port of the second medical storage (co-infusion container) pierces the first rubber plug sealing the first medical storage, the second rubber plug sealing the second medical storage is broken, which allows the co-infusion process to be commenced. See patent publication No. 1. 
     Patent Publication No. 1: Japanese Examined Patent Publication No. 6-59302 
     DISCLOSURE OF THE INVENTION 
     Problem to be Solved by the Invention 
     In the prior art, a rubber plug (second rubber plug) seals the co-infusion container (second medical storage). Upon a piercing of a rubber plug (first rubber plug) of the first medical storage by the needle shaped injection port of the co-infusion container, a relative movement of the body of the needle shaped injection port is generated. Due to such a relative movement, the second rubber plug is opened, so that a transportation (co-infusion) of the second medicine in the co-infusion container to the first medical storage is occurred. In this prior art, the second rubber plug for obtaining a sealed structure of the co-infusion container is press fitted to the latter in a manner that a relative movement for separating the second rubber plug is generated when commencing a co-infusion process. However, such a press fitting makes the structure to be complicated on one hand and, on the other hand, a number of parts to be increased, resulting in a problem of an increased production cost. Furthermore, it may be likely that the rubber plug is completely separated and is dropped to the space inside the co-infusion container. In order to prevent such a separation from being occurred, an improvement of a rubber plug supported by a flexible member has been proposed, which, however, makes the structure to be highly completed. 
     The present invention aims to overcome the above-mentioned problems in the prior art and to provide a structure by which a positive sealing function is obtained during a transportation (co-infusion) process without increasing number of parts. 
     Means for Solving the Problem 
     According to the invention claimed in claim  1 , a medical transportation device is provided, which comprises: a first body for receiving a medicine from a storage thereof, and; a second body connected relatively movably with the first body and having an opening for discharging the medicine at a position spaced from the fist body; the medicine being normally under a sealed condition with respect to said opening; said first and second bodies having, in the direction of said relative movement, opposed areas, which are at least partially broken during said relative movement for releasing said sealed condition, thereby allowing the transportation of the medicine from said opening. 
     According to the invention claimed in claim  2 , a medical transportation device according to claim  1  is provided, wherein said at least partially broken part during said relative movement is a weak part, which is integrally formed to the rest. 
     According to the invention claimed in claim  3 , a medical transportation device is provided, which comprises: a first cylindrical body for receiving a medicine from a storage thereof, and; a second cylindrical body slidably movably inserted to the first cylindrical body and having an opening for discharging the medicine at a position spaced from the fist body; said first and second cylindrical bodies having first and second ends, respectively, which are opposite in the direction of said slide movement; the medicine being normally under a sealed condition in said first cylindrical body; a relative slide movement between the first and second cylindrical bodies causing said opposed ends to be contacted with each other, so that a part of the first end contacting the second end is at least partially broken, resulting in a release of the sealed condition of the medicine in the first cylindrical body, thereby allowing the medicine to be transported from said opening. 
     According to the invention claimed in claim  4 , a medical transportation device is provided, which is for transporting, to a first medicine sealed in a first storage by a plug made of an elastic material, a second medicine in a second storage, said device comprising: a first cylindrical body opened to the second storage for receiving the medicine from the second storage, and; a second cylindrical body slidably movably inserted to the first cylindrical body and having a needle portion at its end remote from said first cylindrical body: said needle portion being adapted for piercing to said plug for transporting said second medicine into said first storage; said first and second cylindrical bodies having first and second ends, respectively, which are opposite in the direction of said slide movement; the second medicine being normally under a sealed condition in said first cylindrical body; a relative slide movement between the first and second cylindrical bodies causing said opposed ends to be contacted with each other, so that a part of the first end contacting the second end is at least partially broken, resulting in a release of the sealed condition of the medicine in the first body, thereby allowing the medicine to be transported from said needle portion. 
     According to the invention claimed in claim  5 , a medical transportation device according to claim  4  is provided, wherein a value of slide resistance force between the first and second cylindrical bodies is larger than a value of piercing resistance force of said plug by said needle portion. 
     According to the invention claimed in claim  6 , a medical a medical transportation device according to claim  3  or  4  is provided, wherein said part of the first end of the first cylindrical body broken at least partially is a lug, which extends, in cantilever fashion, toward the second end of the second cylindrical body. 
     According to the invention claimed in claim  7 , a medical transportation device according to claim  6  is provided, wherein said lug is an integrally formed part of said first cylindrical body, and said first end is provided with a weak part connected to said lug. 
     According to the invention claimed in claim  8 , a medical transportation device according to claim  6  or  7  is provided, wherein said second end of the second cylindrical body has a recess having a shape, which is complimentary with that of the lug at the first end of the first cylindrical member. 
     According to the invention claimed in claim  9 , a medical transportation device according to claim  8  is provided, wherein it further comprises means for relative rotational positioning between said first and second cylindrical bodies during their relative slide movement. 
     According to the invention claimed in claim  10 , a medical transportation device according to any one of claims  3  to  9  is provided, wherein it further comprises means for confirming a completion of said relative movement between the first and second cylindrical bodies until a release of the sealed condition by said breakage. 
     According to the invention claimed in claim  11 , a method is provided for transportation to a first medical storage storing a first medicine under a sealed manner by a plug made of an elastic material from a second storage storing in a sealed manner a second medicine, said method comprising the steps of: providing a transportation device having first cylindrical body opened to the second storage, and a second cylindrical body slidably movably inserted to the first cylindrical body and formed as a needle having an opening at its end remote from the first cylindrical body; inserting at first the medicine in said second storage into said first cylindrical body, while being held therein under a sealed condition; piercing said needle to said plug of the first storage; moving said first and second cylindrical bodies relatively in a manner that said opposed ends in the direction of the relative movement are contacted and broken at least partially, so that said sealed condition of the second medicine in the first body is released, and; moving the second medicine into the first storage by way of said opening, so that the second medicine is mixed to the first medicine in said first storage. 
     According to the invention claimed in claim  12 , a medical transportation device according claim  11 , further comprising the step of adjusting a value of a resistance force of the slide movement between the first and second cylindrical bodies is larger than a value of resistance force as occurred when said plug is pierced by said needle portion. 
     Operational Effects of the Invention 
     In an operational effect of the invention claimed in claim  1 , the medicine in the first body is inwardly sealed under a usual condition, which prevents the medicine from being discharged from the opening. A discharge of the medicine is obtained by a relative movement between the first and second bodies, by which relative movement the opposed areas are at least partially broken, resulting in a release of the inner sealed condition of the medicine and in a discharge of the medicine by way of the opening. Thanks to the release of the medicine by the breakage of the opposed areas, a separate part otherwise needed, such as a rubber plug, is eliminated, resulting in a corresponding reduction in cost, while obtaining a simplified and positive opening operation. 
     In an operational effect of the invention claimed in claim  2 , the integrated structure of the partial breakable part assures a further reduction in the cost, while keeping a reliable release operation. 
     In an operational effect of the invention claimed in claim  3 , the partial breakage by the contact of the opposed ends of the first and second tubular bodies assures a further simplified and positive releasing operation, while assuring a cost reduction by a reduction in part number as well as a simplification of the construction. 
     In an operational effect of the invention claimed in claim  4 , a piercing of the needle part of the second container to the plug of the first container together with a relative slide movement between the first and second tubular bodies until a mutual contact of the respective opposed ends assures that the first tubular body facing the second tubular body is at least partially broken, resulting in the release of the sealed condition of the second medicine in the first tubular body, so that the second medicine is transported into the first container via the needle shaped part pierced to the plug of the first container. As a result, a positive co-infusion of the second medicine into the first medicine is obtained. Furthermore, the release of the sealed condition by the partial breakage assures a cost reduction thanks to the reduction in part number as well as a simplified structure. 
     In an operational effect of the invention claimed in claim  5 , a release of the sealed condition of the second medicine by the relative movement of between the first and second tubular bodies is done after the completion of the piercing of the needle part to the plug of the first container, which eliminates any possibility of leakage of the second medicine during the execution of the co-infusion operation. 
     In an operational effect of the invention claimed in claim  6 , the broken part is constructed by the lug toward the opposed wall, to which a bending force is applied in a manner that the lug is broken at its root portion, thereby assuring a reliable release operation. 
     In an operational effect of the invention claimed in claim  7 , the lug of integrated structure makes its molding process to be simplified, on one hand and, on the other hand, the release of the sealed condition to be reliable due to the fact that the lug is able to be positively broken. 
     In an operational effect of the invention claimed in claim  8 , the lug after the completion of the breakage is stored in the recessed portion, so that an increased co-infusion efficiency is obtained, on one hand and, on the other hand, the broken part is prevented from being floated in the inside space. 
     In an operational effect of the invention claimed in claim  9 , the provision of the positioning means makes it possible that the lug and the recess are reliably engaged when a release of the sealed condition is done. 
     In an operational effect of the invention claimed in claim  10 , the provision of the means for confirming the release of the sealed condition by the breakage assures that a co-infusion operation is reliably practiced even when an operator is untrained. Such a confirmation means is constructed by any suitable means including auditory means such as clicking means and visual means including an identification mark or characters et al. 
     In an operational effect of the invention claimed in claim  11 , a piercing of the needle part of the second container to the plug of the first container followed by a relative slide movement between the first and second tubular bodies assures that that a release of the sealed condition of the second medicine and a subsequent transportation of to the first container are obtained for obtaining a simplified and a reliable mixing operation with the first medicine. 
     In an operational effect of the invention claimed in claim  12 , a release of the sealed condition of the second container is surely occurred after the completion of the piercing to the plug of the first container, so that a positive transportation of the second medicine in the second container is obtained, while preventing any leakage from being occurred. 
    
    
     
       BRIEF EXPLANATION OF ATTACHED DRAWINGS 
         FIG. 1  is a partially sectional plan view of a port body and needle body prior to their assembly, viewed along lines I-I in  FIG. 2 . 
         FIG. 2  is similar to  FIG. 1  but illustrates a partially sectional side view, taken along line II-II in  FIG. 1 . 
         FIG. 3  is an end view of the port body at a portion spaced from the side where a soft container is to be located, taken along lines III-III in  FIG. 1 . 
         FIG. 4  is a transverse cross-sectional view of the fitted part between the port body and the needle body, taken along lines IV-IV in  FIG. 6 . 
         FIG. 5  is a transverse cross-sectional view of the needle body, taken along lines V-V in  FIG. 1 . 
         FIG. 6  is a partially sectional plan view of a co-infusion assembly under an assembled but non-released condition, taken along lines VI-VI in  FIG. 7 . 
         FIG. 7  is a partially sectional plan view of a co-infusion assembly under an assembled but released condition, taken along lines VII-VII in  FIG. 6 . 
         FIG. 8  is a partially sectional plan view of a co-infusion assembly during an execution of co-infusion operation. 
         FIG. 9  is a partially sectional plan view of a co-infusion container provided with a means for confirming a released condition based on an alignment of projected parts, wherein (a) illustrates a non-released condition and (b) a released condition. 
         FIG. 10  is a partially sectional plan view of a co-infusion container provided with a means for confirming a released condition based on an alignment of transparent parts, wherein (a) illustrates a non-released condition and (b) a released condition. 
         FIG. 11  is a partially sectional plan view of a co-infusion container provided with a means for confirming a released condition based on a closure of indexing part, wherein (a) illustrates a non-released condition and (b) a released condition. 
         FIG. 12  is a partially sectional plan view of a co-infusion container provided with a means for confirming a released condition based on a coincidence of index marks, wherein (a) illustrates a non-released condition and (b) a released condition. 
     
    
    
     EXPLANATION OF REFERENCE NUMERALS 
     
         
         
           
               10  Port Body 
               11  Needle Body 
               12  Central Flow Channel of Port Body 
               20  Breakable Lug 
               30  Positioning Rib 
               40  Central Flow Channel of Needle Body 
               42  Needle Part 
               46  Side Hole 
               50  Recess For Reception of Breakable Lug 
               60  U-Shaped Guide 
               62  Guide Groove 
               80  Soft Container 
               84  Space for Storing Medicine of Soft Container 
               90  Infusion Bag 
               94  Space of Infusion Bag 
               96  Port Member of Infusion Bag 
           
         
       
    
     BEST MODE FOR PRACTICING THE INVENTION 
     Now, a first embodiment of the present invention will be explained, which is directed to a medical injection device for injecting (co-infusing), into an infusion bag (first medical storage) for storing therein with a medicine(s) such as a glucose and physiological saline solution et al (first medicine(s)), a different medicine(s) such as a vitamin(s) (second medicine(s)). In  FIGS. 1 and 2 , medical injection device includes a port body  10  (a first body or a first cylindrical body of the invention) and a needle body  11  (a second body or a second cylindrical body of the invention). As will be explained later, the port body  10  is connected to a soft container (second container) made of plastic films for storing therein with a second or additional medicine(s) for a co-infusion. As also be explained later, the needle body  11  has a needle portion, which is pierced to a rubber plug of an infusion bag, so that the medicine stored in the plastic soft container is introduced (co-infused) into the infusion bag. 
     In  FIGS. 1 and 2 , the port body  10  is preferably made of a plastic material, which has rigidity high enough to make the port body to maintain its shape and which includes, although non-exclusively, ABS (acrylonitrile-styrene-butadien co-polymer) resin, PP (polypropylene) resin, PE (polyethylene) resin, rigid PVC (polyvinyl chloride) resin, PC (polycarbonate) resin, COP (cycloolefin) resin, PS (polystyrene) resin, acrylate resin or PET (polyethylene terephthalate) resin, et al. The port body  10  forms, generally, a cylindrical shape and has a central flow channel  12 , which extends in the axial direction. The central flow channel  12  has an opened first end  12 - 1  remote from the needle body  11 , which is more or less widened and has a closed second end  12 - 2  located adjacent the needle body  11 . At the end faced with the needle body  11 , the port body  10  forms a vertical wall  14  located below the horizontal diametric line, an inclined wall  16  of relatively thin thickness located above the horizontal diametric line, providing an axially projected part  10 - 1  and an uppermost vertical wall  18  as an extension from the inclined wall  16  (See also  FIG. 3 ). In short, the portions  14 ,  16  and  18  construct an end wall of the port body  10  faced with the needle body  11 , which extends along the entire area of the end of the central flow channel  12  adjacent the needle body  11 . In other words, the central flow channel  12  is usually closed at the end adjacent the needle body  11 . 
     As shown in  FIG. 3 , the inclined wall  16  is integrally formed with a lug  20  of a rod shape. Due to the inclination of the wall  16 , the lug  20  is directed downward with respect to the axis of the port body  10  as shown in  FIG. 1  and extends across the vertical wall portion  18 , which is the end of the port body  10  adjacent the needle body  11 . When the port body  10  is inserted into the needle body  11  as will be fully explained later, the lug  20  is initially engaged with the opposed surface of the needle body  11 , which causes the lug  20  to be bent downward in  FIG. 1 . The inclined wall  16 , from which the lug  20  is extended, is thin walled at the root end of the lug  20  and forms a weak or breakable part  22 . An engagement of the lug  20  with the opposed surface of the needle body  11  causes the lug  20  to be forced downward, so that the lug  20  is finally broken at the weak part  22  at least at the stretched side, so that the seal or closure of the port body  10  at the end adjacent the needle body is released, which causes the central flow channel  12  to be opened to the needle body  11 . Such a thin walled portion  22  in the inclined wall  16  is formed at the entire or partial periphery of the breakable lug  20 . Furthermore, the lug  20  may be hollowed, so that a thin walled structure is obtained along its entire or partial peripheral wall. Furthermore, in order to obtain an easily breakable structure, the lug  20  may advantageously be formed with an U-shaped notch(s) functioning as a thin walled portion according to the present invention. 
     The port body  10  is formed with an annular groove  24  along its outer periphery, to which annular groove  24  O-ring  26  is fitted, which O-ring is for obtaining a sealing function of the inserted portion between the port body  10  and the needle body  11 . Furthermore, the port body  10  is, at its diametric opposed locations of its outer periphery, formed with positioning ribs  30  (positioning means according to the present invention), each of which ribs extends along the longitudinal direction from an ring shaped flange portion  28  to a location adjacent the annular groove  24 . As will be explained later, when the port body  10  is inserted to the needle body  11 , these ribs  30  are fitted to respective positioning grooves of the needle body  11 , so that a relative positioning between the parts  10  and  11  is positively obtained in a circumferential direction, thereby preventing the parts  10  and  11  from relatively rotating. Finally, the rib  30  is, at its opposed side surfaces, integrally formed with semispherical shaped projections  32  for obtaining locking function. 
     Furthermore, the port body  10  is formed with a flattened flange portion  34  at a location on the side of the open end  12 - 1  of the central flow channel  12 . As will be explained later, plastic films constructing a soft container for storing a medicine(s) for a co-infusion are thermally bonded to the flange portion  34  under a liquid sealed manner. 
     Now, a construction of the needle body  11  will be explained. The needle body  11  is, as similar to the port body  10 , formed as a cylindrical shape and is preferably made of a plastic material, which is rigid enough for needle body  11  to maintain its shape and which include, although non-exclusively, ABS (acrylonitrile-styrene-butadien co-polymer) resin, PP (polypropylene) resin, PE (polyethylene) resin, rigid PVC (polyvinyl chloride) resin, PC (polycarbonate) resin, COP (cycloolefin) resin, PS (polystyrene) resin, acrylate resin or PET (polyethylene terephthalate) resin, et al. The needle body  11  is generally formed as a cylindrical shape and has a central flow channel  40  extending axially. The channel  40  has a first, straight open end  40 - 1 , to which the leading end of the port body  10  is inserted as will be explained later and a second end  40 - 2  extending to a needle part  42  of the needle body  11 . The central flow channel  40  has a reduced inner diameter at the needle part  42 . The needle body  11  has side holes  46  opened outside at locations slightly upstream from a pointed end  42 - 1  of the needle part  42 . During a co-infusion process, a medicine from the co-infusion container is transported to an infusion bag via the side holes  46  as will be described later. 
     The straight portion of the central flow channel  40  has an inner bottom  40 - 3 , which is formed with a pair of raised lands  48  ( FIG. 5 ) astride the longitudinal axis of the central flow channel  40 . These lands  48  terminate at edges  48 - 1  and  48 - 2  crossing at angle of 90 degree, so that a groove or recess  50  extending along the diametric direction is formed between the opposed edges  48 - 2  and a crescent shaped recess  51  is formed on one side of the inline edges  48 - 1  away from the lands  48 . The groove  50  has a width, which is more or less larger than the diameter of the lug  20  of the port body  10 . When an insertion of the port body  10  into the needle body  11  is commenced for the co-infusion operation, the lug  20  is reliably received by the groove  50 . In the situation that the insertion of the port body  10  into the needle body is completed and the lug  20  is broken at the weak portion  22 , the lug  20  is completely stored and held in the groove  50 , resulting in a reduction of a dead space volume, on one hand and, on the other hand, a waste-less transportation of the medicine in the co-infusion container into the infusion bag. 
     As shown in  FIG. 1 , the needle body  11  is, on its outer surface, formed with an annular groove  54  at a location adjacent the needle  42 . An O-ring  56  is fitted to the annular groove  54  for obtaining a seal function with respect to a needle protection cap  58  as shown in  FIG. 6 . Furthermore, the needle body  11  is integrally formed with a pair of U-shaped guides  60  at diametrically opposed positions adjacent the open end of the needle body  11  away from the needle  42 - 1 . As shown in  FIG. 2 , each of the guides  60  is formed as a U-shaped cross-section and is provided with an inner guide groove  62  opened to the port body  10 . Thus, the guide ribs  30  of the port body  10  are capable of being inserted to the respective guide grooves  62 . As shown in  FIG. 2 , each of the guide grooves  62  is provided with a pair of opposed inner walls, each of which is formed with a series of stepped tapered surfaces  62 - 1  and  62 - 2  and locking notches  62 A and  62 B at the ends of tapered surfaces  62 - 1  and  62 - 2 , respectively. As will be described later, the locking projections  32  of the guide ribs  30  on the port body  10  are selectively engaged with these locking notches  62 A and  62 B, so that a locking or detent of two stepped varied depth of the port body  10  with respect to the needle body  11  is obtained between a sealed condition, where the device is assembled but not released and a fully push-in condition, where the device is released and a co-infusion process is done. 
     The O-rings  26  and  56  are made from an elastic material although not limitative, which includes a rubber, such as silicon rubber, butyle rubber, isoprene rubber or natural rubber or a high-molecular elastomer, such as styrene based elastomer, olefin based elastomer, polyester based elaster or nylon based elastomer. 
     Now, a manner of use of the medical transportation device of the present invention will be explained, when applied for a co-infusion process to an infusion bag.  FIGS. 6 and 7  illustrate an assembled condition of the port body  10  and the needle body  11 , wherein the port body  10  is, from its closed end, inserted to the open end  40 - 1  at the rear end of the needle body  11 . Prior to the insertion, a positioning is done in a rotating direction between the port body  10  and the needle body  11  in a manner that the ribs  30  on the port body  10  is aligned with guide grooves  62  on the needle body  11  and that the projected part  10 - 1  of the port body  10  is opposed with the recess  51  of the needle body  11 . When such a positioning is obtained, the port body  10  is pushed into the needle body  11 , which causes the positioning ribs  30  to be guided and inserted into the respective guide grooves  62 . By a further insertion of the port body  10  into the needle body  11 , the lock projections  32  on the positioning ribs  30  move on the first tapered surfaces  62 - 1  of the respective guide groove  62 , so that a condition as shown in  FIG. 7  is finally obtained, where the lock projection  32  climbs over the first tapered surface  62 - 1 . At this condition, the lock projection  32  of the positioning rib  30  engages with the lock notch (recessed portion)  62 A at a leading end of the second tapered surface  62 - 2 . As a result, the port body  10  and the needle body  11  are locked at the relative axial position (an assembled but non-released state) as shown in  FIGS. 6 and 7  against some degree of a resilient force. In this assembled position, the weak, lug  20  at the leading end of the port body  10  is, as shown in  FIG. 6 , faced with the groove  50  between the lands  48  and spaced from the faced bottom wall  40 - 3  of the cylindrical bore of the needle body  11 , so that the lug  20  maintains the integrated condition with respect to the remaining part of the port body, i.e., the thin walled inclined wall  16  ( FIG. 3 ). Thus, the central flow channel  12  of the port body  12  maintains the closed or non-released condition at the end  12 - 2  adjacent the needle body  11 . Finally, a needle cap  58  is attached. 
     In the assembled condition between the port body  10  and the needle body as shown in  FIGS. 10 and 11 , a formation of a soft container for co-infusion as well as a sealed introduction of a medicine are done. Namely, a pair of plastic resin films is superimposed and their opposed outer peripheral portions are subjected to a thermally bonding process, so as to obtain a bag (soft container). Such a soft container is shown partly by a reference numeral  80  in  FIG. 6  and has a sealed part  82  (thermally bonded part of the plastic films) along the outer periphery of the container. However, the soft container  80  is partly non-sealed at a location along the outer periphery, so that an opening is formed. To the opening, the flattened flange portion  34  of the port body  10  is inserted and the plastic films at the opening of the soft container  80  are, then, welded to the opposed outer surface of the flattened flange  34 . Then, a medicine(s) is introduced into a space  84  inside the soft container  80 , which is sealed in a well-known manner. Thus, a co-infusion container assembly as shown in  FIG. 6  is obtained, which assembly is constructed by an injector part constructed by the port body  10 , to which the needle part  11  is fitted, with the needle  42  covered by the needle cap  58  and the soft container  80  connected to the injector part. 
     Next, a co-infusion operation to an infusion bag, using the container assembly shown in  FIGS. 6 and 7  will be explained. As illustrated in  FIG. 8 , such an infusion bag  90  (soft container) may, in a well known manner, be constructed by a pair of superimposed, plastic films, which are thermally bonded for forming a bag having a thermally bonded outer peripheral part  92 , having an inner space  94  for storing a medicine(s) for an infusion, such as glucose liquid and/or physiological saline solution and by an inlet port  96  at an upper end of the thermally bonded outer peripheral part  92 . The inlet port  96  is a molded article of a cylindrical shape from a suitable plastic resin material. The inlet port  96  is, at its outer end, provided with a plug  98  made of a resilient material, such as a rubber. In order to transport (co-infuse) the medicine in the soft container  80  into the infusion bag  90 , the co-infusion assembly is entirely pushed toward the infusion bag  90  in a manner that the needle  42  of the assembly pierces the rubber plug  98  of the bag  90 . A force needed for obtaining a slide movement between the port body  10  and the needle body  11  (slide resistance) is made larger than a force needed for piercing the rubber plug  98  with the needle  42  (piercing resistance) by suitable adjustments of various factors, such as a degree of fitting between the port body  10  and the needle body  11 , a shape of the needle and a type of surface working, et al. As a result, a relative position between the port body  10  and the needle body  11  as shown in  FIG. 6 , i.e., the position of the lug  20  spaced from the opposed surface  40 - 3 , is maintained until the needle  42  is pierced fully to the rubber plug  98  as shown in  FIG. 8 . As a result, the closed or non-released state of the end  12 - 2  of the central flow channel  12 , i.e., the sealed state of the medicine in the soft container  84  is maintained. As a result, the medicine in the soft container  80  is prevented from being issued or leaked from the assembly. 
     In order to commence a co-infusion operation, under a condition that the needle  42  is completely pierced to the rubber plug  98  as shown in  FIG. 8 , the co-infusion bag assembly is further pushed along a direction toward the medical bag  90 , which finally causes the port body  10  to be displaced against the slide resistance with respect to the needle body  11 , so that a relative slide movement of the port body  10  with respect to the needle body  11  is commenced. During such a slide movement, the lug  20  at the tip end of the port body  10  is firstly guided into the groove  50  between the lands  48  ( FIG. 5 ) and is secondly contacted with the opposed surface  40 - 3 , so that the lug  20  is subjected to a bending force directed downwardly in  FIG. 6  due to the downwardly directed inclination, resulting in a breakage of the lug  20  at the weak, thin wall portion at the root  22 . Such an opening or release by the breakage of the lug  20  may occur at the bending side, i.e., the lug  20  may still be connected at the opposite side.  FIG. 8  shows a fully pushed-in condition that the port body  10  and needle body  11  are contacted with each other at their faced ends, where the lug  20  is under an upright position and is stored in the groove  50  between the lands  48 . In this fully pushed-in condition as shown by  FIG. 8 , the locking projections  32  climb over the second taper surfaces  62 - 2  of the guide groove  62  and are engaged with the respective notches  62 B, so that the relative position between the port body  10  and needle body  11  as shown in  FIG. 8 , i.e., the opened state of the assembly is maintained under a resilient force. As a result of the breakage of the lug  20  as shown in  FIG. 8 , the sealed condition at the inclined surface  16  ( FIG. 3 ) is broken or released, resulting in a creation of an opening  89  ( FIG. 8 ), through which the central flow channel  12  of the port body  10  is made communication with the central flow channels  40  and  40 - 2  of the needle body  11 . As a result, the medicine stored in the soft container  80  is introduced into the central flow channels  12 ,  12 - 2 ,  40  and  40 - 2  and is, via the side holes  46 , transported into the space  94  inside the infusion bag  90 . 
     In the above embodiment, when the push-in operation is done until the rapture of the lug  20 , the locking projection  32  climb over to the second notches  62 B shown in  FIG. 7 , which causes a click to be generated, which functions as an auditory notification to an operator that the push-in operation for obtaining an opened condition (a release of the sealed condition) of the device is completed. Additionally or alternatively, a visual means may be provided for notifying a desired push-in depth as obtained even to any untrained operator, thereby preventing an erroneous operation from being occurred. Namely, in the instant embodiment, when a push-in operation is done so that the lug  20  is broken, a gap between the annular flange  28  on the port body  10  and guide rib  30  on the needle body  11  is just cancelled. Thus, a zero value of such gap becomes a verification or notification that a desired degree of the push-in operation is obtained. 
       FIG. 9  illustrates a modification of confirmation means of the completion of a push-in operation. Namely, in this embodiment, the guide rib  30  of the port body  10  is formed with a projected portion  30 A and the U-shaped guide  60  of the needle body  11  is formed with a projected portion  60 A. At the usual, non-opened condition, where the lug  20  is un-broken as shown in  FIG. 9(   a ), the projected portions  30 A and  60 A are separated from each other. At the opened condition, where the lug  20  is broken as shown in  FIG. 9(   b ), the projected portions  30 A and  60 A are aligned, so that the push-in depth between the port body  10  and needle body  11  for obtaining the opening is easily and positively affirmed. 
       FIG. 10  illustrates a modification of means for a confirmation of the completion of a push-in operation, including a transparent type alignment system. Namely, the port body  10  has, at its tubular part  10 ′ inserted to the needle body  11 , a circumferentially extending transparent band  70 . On the other hand, the needle body  11  has, at its tubular part  11 ′ to which the tubular part  10 ′ of the port body  10  is inserted, a circumferentially extending transparent band  72 . The port body  10  and the needle body  11  are made opaque by printing or label adhesion or embossing (surface roughing) et al at locations other than those where the transparent band  70  and  72  are located. In a usual non-opened condition, where the lug  20  is unbroken as shown in  FIG. 10(   a ), the transparent band  70  and  72  are axially spaced and not overlapped, thereby preventing from being entirely see-through. In an opened condition, where the lug  20  is broken as shown in  FIG. 10(   b ), the transparent band  70  and  72  are overlapped and thus entirely see-through, which becomes a notification of a completion of a desired depth of push-in operation. 
     In the embodiment of  FIG. 10 , a modification is possible, wherein a suitable letter, such as “RELEASE” or “OPEN”, is printed on the band shaped area  70  of the port body  10 , which is now not necessarily be transparent. In a usual non-opened condition, where the lug  20  is unbroken as shown in  FIG. 10(   a ), the transparent band  70  and  72  are axially spaced and not overlapped, so that the band  70  is covered by the non-transparent part of the needle body  11  located on the upper side, which prevents the letter of “RELEASE” or “OPEN” from being seen. In an opened condition, where the lug  20  is broken as shown in  FIG. 10(   b ), the transparent band  70  and  72  are overlapped, so that the letter of “RELEASE” or “OPEN” printed on the band area  70  of the port body  10  located on the lower side is seen through the transparent band area  72  of the needle body  11  located on the upper side, which functions as a notification of a completion of a desired depth of push-in operation. 
       FIG. 11  shows a different embodiment of a confirmation means of a push-in depth, where an identification part  74  is provided on the port body  10 , which part is closed during the opened condition. Namely, the identifying part  74  is a letter, such as “NON-RELEASE” or “CLOSE” or a mark or line et al and is arranged at the location adjacent the flange  28 . In a usual non-opened condition, where the lug  20  is unbroken as shown in  FIG. 11(   a ), the flange  28  is spaced from the end of the needle body  11 , so that the identification part  74  is outwardly exposed, causing an operator to notice the indication of “NON-RELEASE” or “CLOSE”. In an opened condition, where the lug  20  is broken as shown in  FIG. 11(   b ), the indication such as “NON-RELEASE” or “CLOSE” is covered by the needle body  11 , which is opaque, which prevents the letter or line from being visually noticed, which functions as a notification of a completion of a desired depth of push-in operation. 
       FIG. 12  shows a different embodiment of a confirmation means of a push-in depth for a confirmation by a coincidence of lines. Namely, on the outer periphery of the port body  10 , a first judging mark  76  of line shape is printed. On the needle body  11 , a second judging line  78  astride a groove  11 B is printed at the end of the body  11 . In a usual non-opened condition, where the lug  20  is unbroken as shown in  FIG. 12(   a ), the lines  76  and  78  are spaced, so that a judgment of un-opened condition is obtained. In an opened condition, where the lug  20  is broken as shown in  FIG. 12(   b ), the lines  76  and  78  are coincided, so that a judgment of opened condition is obtained.