Patent Publication Number: US-2023146155-A1

Title: A medical syringe barrel and a package thereof

Description:
TECHNICAL FIELD 
     The present invention relates to a medical syringe barrel for constituting a medical syringe and a package for transporting it. 
     BACKGROUND ART 
     In general, a medial syringe comprises a syringe barrel having a tip on which a needle is to be attached and a syringe plunger which is to be inserted into the syringe barrel from an opening on the other end for moving a piston in the axial direction. A flange is formed at the opening on the other end of the syringe barrel to project radially outward. There are the Lure Tip type, the Lure Lock type or the like as a type of a syringe tip portion to which an injection needle is to be attached. The structure for fixing an injection needle is determined by the ISO standards in view of medical accident prevention. The Lure Lock type is a type of having a locking function at a syringe tip portion and it is suitable for connecting with an injection needle firmly. 
     Although the diameter of a Lure Lock part as the tip portion of a syringe barrel is determined by the ISO standards, it is necessary to reduce the inner diameter of the barrel section in which an internal-use solution is filled in a minimal capacity syringe in view of necessity of keeping a predetermined stroke for the sake of being easy to use at the time of injection. When a syringe barrel having an outer diameter of a barrel section which is equal to the diameter of a Lure Lock section is manufactured by injection molding of a thermoplastic resin material, it causes a molding defect in the barrel section having an increased wall thickness. For this reason, as shown in Patent Document 1, a barrel was proposed for keeping a sufficient stroke by making the outer diameter of a barrel section smaller than the diameter of the Lure Lock section. Patent Document 2 discloses a structure of a syringe barrel comprising a large outer diameter section at the end edge side which has an inner diameter larger than the inner diameter of an intermediate section. 
     For simplifying the medicine management, controlling the infection, preventing errors at the time of dispensing, speeding up the administration and so on, a prefilled syringe, in which an accurate dosage of medicine is previously filled, is used. In general, the components for assembling a syringe like a syringe barrel, a piston and a plunger are transported to a pharmaceutical company, and it is filled with an internal-use solution and a syringe is assembled. Therefore, it is necessary to transport a syringe keeping a sterilized state, and it is proposed to use a container comprising a nest and a tub as shown in Patent Documents 3 and 4 as an example. 
     Patent Document 1: Japanese laid-open patent application 2013-116289
 
Patent Document 2: Japanese design registration No. 1468280
 
Patent Document 3: International laid-open patent application WO2014/109011A1
 
Patent Document 4: Japanese patent No. 6040025
 
     DISCLOSURE OF INVENTION 
     Problems to be Resolved by the Invention 
     When a syringe barrel shown in Patent Document 1 or 2 is stored in a nest shown in Patent Document 3 or 4 for transporting the syringe barrel together with other components like a piston and a plunger to a pharmaceutical company for assembling a syringe as a prefilled syringe, a rattle is generated in the nest at the time of transportation. There is a possibility that the rattle causes a breakage by bringing members into contact mutually during the transportation, and it may cause trouble when the syringe barrel is drawn from the nest. 
     Therefore, it is desired to provide a syringe barrel and a package thereof which can prevent the members from undesirable mutual contact at the time of transporting them in a nest and drawing from the nest and thereby realize easy drawing operation. 
     Means for Solving the Problems 
     (1) A medical syringe barrel according to the present invention comprises a tubular barrel section for accommodating an internal-use solution in the interior thereof, an injection nozzle section formed at one end of the barrel section, and a flange section formed at an opening section on the other end of the barrel section to project radially outward. 
     The barrel section includes an intermediate body part having an outer diameter which is smaller than the outer diameter of the injection nozzle section and a large outer diameter barrel section having an outer diameter which is equal to the outer diameter of the injection nozzle section. The large outer diameter barrel section is formed between the flange section and the intermediate body part. 
     When a medical syringe barrel configured as described above is inserted into a tubular member of a nest from above taking the syringe barrel with the injection nozzle section facing down, the injection nozzle section having an outer diameter which is slightly smaller than the inner diameter of the tubular member of the nest passes through the tubular member, the intermediate body part and the large outer diameter barrel section are inserted into the tubular member in this order, and then the syringe barrel is stored in the tubular member by bringing the flange section into contact with the upper end of the tubular member. 
     By setting the outer diameter of the large outer diameter barrel section equal to the outer diameter of the injection nozzle section, it becomes possible to prevent rattle of the syringe barrel in the tubular member when the syringe barrel is transported by storing in the nest. It becomes hard to cause displacement because the center axis of the tubular member coincides with the center axis of the syringe barrel. It also makes easy to draw the syringe barrel from the tubular member in a straight line. 
     (2) In a medical syringe barrel according to the present invention described in (1), the axial length of the large outer diameter barrel section is set to ⅓ or less of the axial length of the barrel section. 
     By setting the length of the large outer diameter barrel section to an appropriate value, it is possible to restrain rattle of the syringe barrel inside the tubular member, prevent displacement and make the drawing of the syringe barrel from the tubular member easier more effectively. On the other hand, if the large outer diameter barrel section is too long, there is an inconvenience that the distance between the opening at the flange section side of the syringe barrel and the piston default position (the predetermined content filled position) becomes long at the time of vacuum plugging of the piston. Therefore, it is preferable to set the axial length of the large outer diameter barrel section to ⅓ or less of the length of the barrel section. 
     (3) A package of a medical syringe barrel according to the present invention comprises a nest including a flat plate member and a tubular member, and at least one syringe barrel being held in the nest, the flat plate has at least one opening, one end of the tubular member is connected to the opening and the other end of the tubular member protrudes upward from the flat plate member. 
     The syringe barrel held in the nest includes a tubular barrel section for accommodating an internal-use solution in the interior thereof, an injection nozzle section formed at one end of the barrel section, and a flange section formed at an opening section on the other end of the barrel section to project radially outward. The barrel section includes an intermediate body part having an outer diameter which is smaller than the outer diameter of the injection nozzle section and a large diameter barrel section having an outer diameter which is equal to the outer diameter of the injection nozzle section. 
     The inner diameter of the tubular member is set to a value which is larger than the outer diameter of the large outer diameter barrel section and smaller than the outer diameter of the flange section. The flange section is in contact with the protruding end of the tubular member, and at least a portion of the barrel section is held inside the tubular member. 
     When a medical syringe barrel configured as described above is inserted into a tubular member of a nest from above taking the syringe barrel with the injection nozzle section facing down, the injection nozzle section having an outer diameter which is slightly smaller than the inner diameter of the tubular member of the nest passes through the tubular member, the intermediate body part and the large outer diameter barrel section are inserted into the tubular member in this order, and then the syringe barrel is stored in the tubular member by bringing the flange section into contact with the upper end of the tubular member. 
     By setting the outer diameter of the large outer diameter barrel section to be equal to the outer diameter of the injection nozzle section, it becomes possible to prevent rattle of the syringe barrel inside the tubular member when the syringe barrel is transported. It becomes hard to cause displacement because the center axis of the tubular member coincides with the center axis of the syringe barrel. It also makes easy to draw the syringe barrel from the tubular member in a straight line. 
     (4) In a package of a medical syringe barrel according to the present invention described in (3), the axial length of the large outer diameter barrel section is set to ⅓ or less of the axial length of the barrel section. 
     By setting the length of the large outer diameter barrel section to an appropriate value, it is possible to restrain rattle of the syringe barrel inside the tubular member, prevent displacement and make the drawing of the syringe barrel from the tubular member easier more effectively. On the other hand, if the large outer diameter barrel section is too long, there is an inconvenience that the distance between the opening of the flange of the syringe barrel and the piston default position (the predetermined content filled position) becomes long at the time of vacuum plugging of the piston. Therefore, it is preferable to set the axial length of the large outer diameter barrel section to ⅓ or less of the axial length of the barrel section. 
     Effect of Invention 
     According to a medical syringe barrel and a package thereof according to the present invention, it is possible to secure a sufficient stroke even for operating a Lure Lock type small capacity syringe, and it is possible to restrain rattle of the syringe barrel inside the tubular member, prevent displacement and make the drawing of the syringe barrel from the tubular member easier more effectively at the time of transporting the syringe barrel while holding the syringe barrel in the tubular member of the nest. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG.  1    (A) shows a perspective view of a configuration example of a medical syringe made by assembling a syringe barrel, in which an internal-use solution is filled, according to one embodiment of the present invention together with a piston, a plunger and a finger grip, and (B) shows a perspective view of a medical syringe shown in (A) which is observed from a different angle. 
         FIG.  2    (A) shows an axial cross-sectional view of a syringe barrel according to one embodiment of the present invention, and (B) shows a side view observed from the arrow B in (A). 
         FIG.  3    shows a perspective view of a schematic configuration of a container used for a package of a medical syringe barrel according to one embodiment of the present invention. 
         FIG.  4    shows a partial cross-sectional view of a package of a medical syringe barrel according to one embodiment of the present invention. 
         FIG.  5    shows a perspective view of an exterior appearance of a package of a medical syringe barrel according to one embodiment of the present invention. 
         FIG.  6    shows an example of using a tiptoe of an arm for handling a syringe barrel in a package of a medical syringe barrel according to one embodiment of the present invention. 
     
    
    
     A MODE FOR IMPLEMENTING THE INVENTION 
     A configuration of a medical syringe barrel according to one embodiment of the present invention will be explained below referring to the drawings.  FIG.  1    shows a perspective view of a configuration example of a medical syringe which is assembled by a syringe barrel according to one embodiment of the present invention, a piston, a plunger and a finger grip, in which the syringe barrel is filled with an internal-use solution. This medical syringe is a prefilled syringe with a minimal capacity for ophthalmic use as an example, and a disposable syringe for which a single time use is assumed. 
     In  FIG.  1   , a syringe  10  is an assembly made of a syringe barrel  20 , a finger grip  30 , a syringe plunger  40  and a piston  50 . An internal-use solution  60  is accommodated in a hollow barrel section of the tubular syringe barrel  20 , and it is arranged so that the internal-use solution  60  is pushed out from the tip of the syringe barrel  20  by pushing the piston  50  with the tip of the syringe plunger  40 . 
     As shown in  FIG.  1   , a syringe barrel  20  has a transparent tubular body of a molded article made of glass or a polyolefin resin material as an example, and it is possible to visually recognize the internal-use solution  60 , the piston  50  and a part of the syringe plunger  40  which are inside the hollow barrel section. 
       FIG.  2    is an axial cross-sectional view which shows a configuration of the syringe barrel  20  according to one embodiment of the present invention. The syringe barrel  20  is a molded article by injection molding of a synthetic resin material like a polyolefin resin material, and comprises a tubular barrel section  21  for accommodating an internal-use solution in the interior thereof, an injection nozzle section  22  which is formed at one end of the barrel section  21  and to which a needle as an example is to be attached, and a flange section  23  which is formed at an opening section on the other end of the barrel section  21  to project radially outward. The syringe barrel  20  is used for a minimal capacity syringe of 0.25 m for ophthalmic use as an example. 
     In  FIG.  2    (A), the injection nozzle section  22  is formed as a Lure Lock type and complied with the ISO 80369-7 standards, wherein a screw tube part is connected to the outer side of a cylindrical nozzle tube part, the cylindrical nozzle tube part has a tapered surface, which is formed to be thinner toward the tip, on the outer circumference, and the screw tube part has a male screw on the inner wall. In this structure, by fitting an injection needle to the injection nozzle section  22  firmly, it is possible to certainly prevent the attached injection needle from becoming loose or being dislocated from the injection nozzle section, when it is used in the medical field or the like. Such a syringe barrel  20  may be used for mixed injection to a drip infusion portion, a two-liquid blending syringe between syringes or the like. 
     The injection nozzle section  22  is complied with the International Standards ISO80369-7 for preventing misconnection, and the shape and so on are determined by the standards. In  FIG.  2   , the axial length C of the screw tube part of the injection nozzle section  22  is 70% or longer of the outer diameter D 22 . As shown in  FIG.  2 (B) , the flange section  23  has a shape of connecting both ends of the two arcs by two straight lines respectively when the syringe barrel  20  is observed from the direction shown by the arrow B in  FIG.  2 (A) . The inner wall  22 N of the nozzle tubular part of the injection nozzle section  22 , the inner wall  21 N of the intermediate body part  21 M and the inner wall  24 N of the large outer diameter barrel section  24  are viewed in this order concentrically. 
     In a minimal capacity syringe of 0.25 m for ophthalmic use as an example has a small inner diameter (the diameter of the inner wall  21 N) of the barrel section (the intermediate body part  21 M), in which an internal-use solution is filled, in view of easy use at the time of injection and necessity for keeping a predetermined length of the stroke. 
     In a normal syringe barrel having an equal outer diameter through the range from the injection nozzle section to the end edge of the barrel section (immediately before the flange section), if the inner diameter of the intermediate body part is made smaller, it will cause an imperfect molding which is called as sink marks because the thickness of the barrel section becomes larger. In this embodiment, as the syringe barrel  20  is an injection molded article of a synthetic resin material, the thickness of the intermediate body part  21 M is not made larger and the outer diameter D 21  of the intermediate body part  21 M is made smaller in order to prevent an imperfect molding like sink marks by injection molding. 
     A large outer diameter barrel section  24  having an outer diameter which is larger than the outer diameter of the intermediate body part  21 M is formed between the flange section  23  and the intermediate body part  21 M. The thickness of the large outer diameter barrel section  24  is set to be equal to the thickness of the intermediate body part  21 M, and the inner diameter of the large outer diameter barrel section  24  (the diameter of the inner wall  24 N) is set to a larger value. 
     The outer diameter D 24  of the large outer diameter barrel section  24  is set to a value which is equal to the outer diameter D 22  of the screw tube part of the injection nozzle section  22 . It is preferable to set the outer diameter D 21  of the intermediate body part  21 M to 50% or larger with respect to the outer diameter D 22  of the injection nozzle section  22  or the outer diameter D 24  of the large outer diameter barrel section  24 . There is a continuous curved connection part between the flange section  23  and the large outer diameter barrel section  24 . There is a tapered part between the large outer diameter barrel section  24  and the intermediate body part  21 M. 
     The axial length “d” of the part of the large outer diameter barrel section  24  having an outer diameter which is equal to the outer diameter D 22  of the injection nozzle section  22  is determined in consideration of the length of the intermediate body part which is required for making a minimal capacity syringe and the length of the intermediate body part  21 M which is required for vacuum plugging of the piston. If the axial length “d” of the part of the large outer diameter barrel section  24  having an outer diameter which is equal to the outer diameter D 22  of the injection nozzle section  22  is too long, there is an inconvenience that the distance between the opening and the piston default position (the predetermined content filled positron) becomes longer at the time of vacuum plugging of the piston. The piston default position will not be set in the portion which has a larger inner diameter than the inner diameter of the intermediate body part  21 M for accommodating an internal-use solution. 
     Due to the above considerations, the axial length “d” of the portion of the large outer diameter barrel section  24  having an outer diameter which is equal to the outer diameter D 22  of the injection nozzle section  22  is set to a value in the range of L/3≥d&gt;0 in relation with the length L of the barrel section  21  of the syringe barrel  20 . 
     When a syringe barrel  20  configured as described above is transported to a pharmaceutical company or the like, a container for medical equipment, which comprises a nest and a tub shown in  FIG.  3   , is used. A container  300  comprises a nest  310 , a tub  320  and a film  330 . The nest  310  comprises a flat plate member  311  and plural tubular members  312  which protrude upward from the flat plate member  311 . The flat plate member  311  has plural openings, and one end of each of plural tubular members  312  is connected to each of the openings respectively, and the other ends of the plural tubular members protrude upward from the flat plate member  311 . The inner diameter of each opening is equal to the inner diameter of each tubular member  312 , and they are formed so that the center of each opening coincides with the center of each tubular member  312  respectively. 
     Each tubular member  312  functions as a holder for holding a syringe barrel  20 . As shown in  FIG.  4   , the inner diameter “a” of the tubular member  312  is set to be larger than the outer diameter D 24  of the large outer diameter barrel section  24 , the shortest outer diameter “b” of the flange section  23  is set to be larger than the inner diameter “a” of the tubular member  312 . The flange section  23  is brought into contact with the protruding end of the tubular member  312 , and a part of the barrel section  21  is held inside the tubular member  312 . 
     In this embodiment, when the length “Lb” is a sum of the axial length “d” of the portion of the large outer diameter barrel section  24  which is equal to the outer diameter D 22  of the injection nozzle section  22  and the thickness of the flange section  23 , and the length “La” is a sum of the axial length of the tubular member  312  and the thickness of the flat plate member  311 , it is preferable to set the length “Lb” to 40% through 60% of the length “La.” The length “La” is determined by the ISO standards. 
     As shown in  FIG.  3   , each of the plural syringe barrels  20  is held in each of the plural tubular members  312  in the nest  310  respectively and the nest  310  is stored in the tub  320 . The tub  320  is sealed with a gas impermeable film  330  and then a medical syringe barrel package by the container  300  for medical equipment shown in  FIG.  5    is obtained. The package is sterilized and transported to a pharmaceutical company or a medical institute, When the syringe barrel  20  is for a prefilled syringe, the container  300  can be opened at the pharmaceutical company or the medical institute, and the syringe barrel  20  can be filled with an internal-use solution immediately. 
     Other than the above-described package for sealing the opening portion with a gas impermeable film, the following package configurations are available, and these packaging methods and other known package configurations can be applied to the present embodiment. 
     (1) a method for packaging the entire tub under a reduced pressure condition after sealing the opening portion of the tub with a gas permeable film;
 
(2) a method for sealing the opening portion with a gas impermeable film under a reduced pressure condition after sealing the opening portion with a gas permeable film; and
 
(3) a packaging method for packaging and transporting keeping the cleanliness inside the tub at an appropriate control value which is different from the above-described methods.
 
     Next, the operation of a medical syringe barrel and a package thereof according to the present embodiment will be explained. The syringe barrel  20  having the shape shown in  FIG.  2    is produced by injection molding of a synthetic resin material, and the syringe barrel  20  is inserted into the tubular member  312  from above taking the syringe barrel  20  with the injection nozzle section  22  facing down by supporting the flange section  23  with the tiptoes  600  of the arm, and inserting the injection nozzle section  22 , the intermediate body part  21 M and the large outer diameter barrel section  24  into the tubular member  312  in this order, as shown in  FIG.  6   . A part of the syringe barrel  20  is held by the tubular member  312  by supporting the flange section  23  by the protruding end of the tubular member  312 . 
     As the outer diameter D 22  of the injunction nozzle section  22  is set to be equal to the outer diameter D 24  of the large outer diameter barrel section  24  and the inner diameter “a” of the tubular member  312  is set to be slightly larger than the outer diameters D 22  and D 24  of the two sections, the rattle is prevented inside the tubular member  312 . When the syringe barrel  20  is transported to a pharmaceutical company in a condition of being stored in the container  300  shown in  FIG.  5    and filled with an internal-use solution, the syringe barrel  20  is pulled up by supporting the flange section  23  by the tiptoes  600  of the arm as shown in  FIG.  6   . 
     At this moment, as the outer diameter D 22  of the injection nozzle section  22  is equal to the outer diameter D 24  of the large outer diameter barrel section  24 , the syringe barrel  20  is pulled up in a condition that the center axis of the syringe barrel  20  approximately coincides with the center axis of the tubular member  312 . By this configuration, the syringe barrel  20  can be drawn out from the tubular member  312  in a straight line. 
     Therefore, it is possible to prevent collision of the syringe barrel  20  with a member like the inner wall of the tubular member  312  because the operation of drawing out from the syringe barrel  20  becomes stable. 
     According to the embodiment described above, it is possible to provide a medical syringe barrel and a package thereof which secures a sufficient stroke for operation of a Lure Lock type small capacity syringe, prevents rattle during transportation by holding a syringe barrel inside a tubular member of a nest and makes the drawing out operation easy. A medical syringe barrel and a package thereof according to the present embodiment is preferable for a prefilled syringe which is assembled by filling an internal-use solution in a syringe barrel in advance. 
     EXPLANATION OF REFERENCES 
     
         
           10  syringe 
           20  syringe barrel 
           21  barrel section 
           21 M intermediate body part 
           22  injection nozzle section 
           23  flange section 
           24  large outer diameter barrel section 
           30  finger grip 
           40  syringe plunger 
           50  piston 
           60  internal-use solution 
           300  container 
           310  nest 
           311  flat plate member 
           312  tubular member 
           320  tub 
           330  film 
           600  tiptoe of arm