[go: up one dir, main page]

WO2009061140A2 - Système de seringue et contenant de médicament - Google Patents

Système de seringue et contenant de médicament Download PDF

Info

Publication number
WO2009061140A2
WO2009061140A2 PCT/KR2008/006553 KR2008006553W WO2009061140A2 WO 2009061140 A2 WO2009061140 A2 WO 2009061140A2 KR 2008006553 W KR2008006553 W KR 2008006553W WO 2009061140 A2 WO2009061140 A2 WO 2009061140A2
Authority
WO
WIPO (PCT)
Prior art keywords
drug
syringe
solvent
chamber
sealing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/KR2008/006553
Other languages
English (en)
Other versions
WO2009061140A3 (fr
Inventor
Jin Eon So
Jae Yoon Lee
Joon Ho Lee
Hoon Sung Jeh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LG Chem Ltd
Original Assignee
LG Life Sciences Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by LG Life Sciences Ltd filed Critical LG Life Sciences Ltd
Publication of WO2009061140A2 publication Critical patent/WO2009061140A2/fr
Publication of WO2009061140A3 publication Critical patent/WO2009061140A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • A61M2005/3139—Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
    • A61M2005/31598—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/283—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

Definitions

  • the present invention relates to a syringe system capable of administering a drug in highly dispersed suspension form and a drug container.
  • powder drugs to be injected in suspension form are generally filled into vials.
  • suspension medium is filled into the vial to mix with the powder drug, then the drug in suspension form obtained by shaking the vial is drawn up by a disposable syringe for administration.
  • the suspension medium is oil
  • a syringe system including: a chamber; a sealing unit for sealing an upper portion of the chamber and slidable within the chamber; a drug and solvent containing portion defined by the chamber and the sealing unit and containing a drug and a solvent; and a mixing improvement member for assisting the mixing of the drug and the solvent by movement in the drug and solvent containing portion.
  • a syringe system includes a syringe having a chamber, a first sealing unit for sealing an upper portion of the chamber and slidable within the chamber, and a drug containing portion defined by the chamber and the first sealing unit and containing a drug; and a solvent container including a chamber, a second sealing unit for sealing an upper portion of the chamber and slidable within the chamber, a solvent containing portion defined by the chamber and the second sealing unit and containing a solvent, and a syringe receptor disposed next to an upper side of the second sealing unit.
  • the syringe is capable of being in fluid communication with the solvent container by fitting into the syringe receptor and penetrating the second sealing member.
  • a syringe system including: a syringe including a chamber, a first sealing unit for sealing an upper portion of the chamber and slidable within the chamber, and a solvent containing portion defined by the chamber and the first sealing unit and containing a solvent; and a drug container including a chamber, a second sealing unit for sealing an upper portion of the chamber and slidable within the chamber, a drug containing portion defined by the chamber and the second sealing unit and containing a drug, and a syringe receptor disposed next to an upper side of the second sealing unit, wherein the syringe is capable of being in fluid communication with the drug container by fitting into the syringe receptor and penetrating the second sealing member.
  • a drug container removed from the syringe system for storing a drug in suspension form.
  • a syringe system having a drug mixing improvement member and a syringe system having a syringe and a container prefilled with a drug and a solvent and having a drug mixing improvement member assists an even mixing of the drug and the solvent to make a suspension, and enables to make suspension again from separated layers of the suspension during storage, whereby powder drugs obtained from various method are capable of being administered in a highly dispersed suspension form.
  • FIG. 1 illustrates a cross sectional view of a syringe system in accordance with a first embodiment of the present invention
  • FIG. 2 illustrates a cross sectional view of a syringe system in accordance with a first example of a second embodiment of the present invention
  • FIG. 3 illustrates a cross sectional view of a solvent container forming a syringe system in accordance with the first example of the second embodiment of the present invention
  • FIG. 4 illustrates a cross sectional view of a syringe forming a syringe system in accordance with the first example of the second embodiment of the present invention
  • FIG. 5 illustrates cross sectional views showing operational procedures of a syringe system in accordance with the first example of the second embodiment of the present invention
  • FIG. 6 illustrates a cross sectional view of a syringe system in accordance with a second example of the second embodiment of the present invention
  • FIG. 7 illustrates a cross sectional view of a solvent container forming a syringe system in accordance with the second example of the second embodiment of the present invention
  • FIG. 8 illustrates a cross sectional view of a syringe forming a syringe system in accordance with the second example of the second embodiment of the present invention
  • FIG. 9 illustrates cross sectional views showing operational procedures of a syringe system in accordance with the second example of the second embodiment of the resent invention
  • FIG. 10 illustrates a cross sectional view of a syringe system in accordance with a third embodiment of the present invention
  • FIG. 11 illustrates a cross sectional view of a drug container forming a syringe system in accordance with the third embodiment of the present invention
  • FIG. 12 illustrates a cross sectional view of a syringe forming a syringe system in accordance with the third embodiment of the present invention
  • Figs. 13 and 14 illustrate cross sectional views sequentially showing operational procedures of a syringe system in accordance with the third embodiment of the resent invention.
  • FIG. 15 to 20 illustrate cross sectional views of exemplary drug containers to be used in the syringe system in accordance with the third embodiment of the present invention. Best Mode for Carrying Out the Invention
  • syringe chamber is a part of a conventional syringe, e.g., a barrel, a cartridge, and so forth, in which a needle may be fitted to the low end portion of the syringe and the upper portion of the syringe may be insulated by appropriate sealing member.
  • the term "sealing member” refers to an appropriate member such as a plunger of the conventional syringe which insulates the upper portion of the chamber of the syringe to define a space inside the chamber.
  • the mixing member may be moved up and down by means of a rod within the chamber.
  • mixing improvement member is for mixing the drug and the solvent, disposed in the chamber or drug container of the syringe, and made from a material having specific gravity of 2 or more or a material coated with inert or protection substances, thereby not being effected by the drug and the solvent as well as causing no effect on the drug and the solvent.
  • materials are, e.g., stainless steel, glass, plastic, ceramic, and so forth. Among those materials, stainless steel may be preferred.
  • USU316L is preferred which is used for the materials of a container for manufacturing medical products and a needle of a syringe. It is advantageous to follow post processes such as an elector-polishing and a passivity treatment in consideration of stability.
  • the shape and the number of the mixing improvement member may be modified without specific limitation.
  • one or more mixing improvement members having sphere shape or similar of 5mm diameter or less may be used, and it is also possible to have a shape of a cylinder conforming to a cross sectional shape of the chamber. It is effective for the mixing improvement member to have a cylindrical shape or similar shape having a hole along the central axis thereof so that, when the viscosity of the solvent is high or is increased upon mixing the drug and the solvent, or the amount of drug are large, the mixing improvement member can be reciprocally moved without difficulty within a drug containing portion, resulting in easier discharge of the mixed suspension.
  • the mixing improvement member has a cylindrical shape having a hole along the central axis thereof or similar to prevent the needle passed therethrough from damaging and to assist the reciprocal movement and the discharge of the mixed suspension. It is preferable that the mixing improvement member of the cylindrical shape having the hole along the central axis thereof has a diameter of more than 0.7 to less than 1 ratio with respect to an inner diameter of the chamber, more preferably 0.85 to 0.98. A height of such mixing improvement member may be varied depending on characteristics of the drug and the solvent, amounts of the filled drug and solvent, and the outer and inner diameters of the mixing improvement member.
  • the height should be sufficient enough to prevent a rotation of the mixing improvement member in a lateral direction thereof and a damage of a point of the syringe needle.
  • the hole also should have appropriate shape and size to prevent the damage of the needle during mixing procedure.
  • one end portion of the cylindrical mixing improvement member at the bottom end side of the drug container has a rounded shape so as to assist the mixing at the bottom corner portion in the drug container.
  • solvent container and "drug container” refer to members having inner space to store the drug or the solvent which can be fitted with the syringe and can be in fluid communication with the syringe.
  • a tube with one end portion thereof sealed, a prefilled syringe, a cartridge, a barrel, and so forth may be used for the containers.
  • Fig. 1 illustrates a syringe system in accordance with a first embodiment of the present invention.
  • the syringe system includes a barrel 15; a needle inserted to lower end portion of the barrel 15; a plunger 13 sealing an upper portion of the barrel 15; and a rod 17 inserted to upper portion of the plunger 13 to move the plunger 13.
  • a drug containing portion 11 is formed in a space defined by the barrel 15 and the plunger 13.
  • a drug is filled in the drug containing portion 11 and a mixing improvement member 12 is disposed in the drug containing portion 11 to improve the mixing of the drug and a solvent.
  • a needle 18 of the syringe system may be protected by a protection cap 19.
  • the drug to be injected is filled in the drug containing portion 11 in a powder from and converted to an injectable state by injecting the solvent to make suspension.
  • the drug may be filled in the drug containing portion 11 in another form such as suspension.
  • the syringe system After injecting the solvent in the drug containing portion 11 filled with the powder drug, the syringe system is agitated in a lengthwise direction thereof to improve the mixing of the powder drug and the solvent with the mixing improvement member 12 reciprocating in the drug containing portion 11, thereby evenly dispersing the drug into the solvent in a short period time and preventing the drug from sticking to an inner wall of the drug containing portion 11. Further, in case that a drug is stable in suspension form for long period time, the drug in suspension form is stored in the drug containing portion 11 with the mixing improvement member 12. To administer the drug, a drug sedimented during storage is converted to an evenly dispersed drug in suspension form again by simply agitating the stored syringe system several times.
  • the dry powder according to the present invention may be manufactured in various method, such as rapid solvent removal method, spray drying method, roller drying method, solvent sedimentation method, and lyophilization method. Further, the syringe system according to present invention is advantageous to administer protein drug, sustained release type peptide drug, and vaccine which were administered in suspension form by conventional prefilled syringe.
  • the barrel, plunger, rod, and needle among the components of the syringe system according to present invention may have any material, shape, and size conventionally used in medical field.
  • the syringe system having the mixing improvement member 12 according to present invention is conveniently used to administer the mixed drug in highly dispersed suspension form obtained by mixing the powder drug and the solvent with simple operation of agitating it in lengthwise direction thereof.
  • FIGs. 2 to 9 illustrate exemplary syringe systems for administering drug in accordance with a second embodiment of the present invention.
  • Fig. 2 shows one syringe system in accordance with the second embodiment of the present invention.
  • the syringe system includes a solvent container 210 and a syringe 220 fitted to the solvent container 210 and filled with a drug.
  • the solvent container 210 may have rounded shape or chamfered edge at a lower end portion thereof to prevent it from damaging by a point of a needle penetrating the plunger 213 when assembling.
  • the solvent container 210 includes a barrel 215; the solvent containing portion 211; a plunger 213 sealing the solvent containing portion 211 and slidable in a lengthwise direction thereof, and a syringe receptor 214 disposed next to the plunger 213 in an upper end direction thereof.
  • a supporting member 216 At the upper end portion of the barrel 215, there is provided a supporting member 216 outwardly extended for operational convenience.
  • the syringe 220 includes a barrel 225; a drug containing portion 221; a plunger 223 sealing the drug containing portion 221 and slidable in a lengthwise direction thereof; a needle 228 fitted to an end portion of the barrel 225; a rod 227 inside the barrel 225 to move the plunger 223; and a supporting member 226 provided at an upper end portion of the barrel 225 to support the operation of the rod 227.
  • the needle 228 of the syringe 220 may be protected by a needle protection cap 229.
  • the drug containing portion 221 may be provided with a mixing improvement member 222 to assist the mixing of the drug and the solvent.
  • Fig. 5 shows operational procedures of the syringe system shown in Fig. 2.
  • the needle 228 of the syringe 220 is penetrated through the plunger 213 of the solvent container to contact with the solvent.
  • the supporting member 216 of the solvent container 210 and the supporting member 226 of the syringe 220 is pushed together in arrow directions as shown in first drawing of Fig. 5, then the solvent is transferred to the drug containing portion 221 of the syringe 220 due to the pressure acting on the solvent containing portion 211 while moving the plunger 223 backward.
  • the drug and the solvent are then mixed by agitating the syringe system in lengthwise direction, as shown in second drawing of Fig. 5.
  • the mixing improvement member 222 which is optionally used assists the mixing.
  • the mixed drug can be administered after removing the syringe 220.
  • FIG. 6 shows the other syringe system in accordance with the second embodiment of the present invention.
  • a solvent container 210' shown in Fig. 6 may be that of a conventional prefilled syringe system shown in Fig. 7 which includes a barrel 215'; the solvent containing portion 211 ' ; a plunger 213' sealing the solvent containing portion 211' and slidable in a lengthwise direction thereof, and a syringe receptor 214' disposed next to the plunger 213' in an upper end direction thereof.
  • a supporting member 216' outwardly extended for operational convenience.
  • the lower end portion of the barrel 215' may be sealed with sealing device such as a Luer lock 230' and Luer lock sheath 231'.
  • the syringe system is formed by inserting the needle 28' of the syringe 220' into the syringe receptor 214' as shown in Fig. 8.
  • the needle 228' may be protected by a needle protection cap 229'.
  • a supporting member 226' At the upper end portion of the syringe 220', there is provided a supporting member 226' for operational convenience.
  • the supporting member 226' may be formed to have the shape for use in conventional prefilled syringe systems, it is preferable for the supporting member 226' to have a shape having a groove at a center portion thereof conforming to a shape of an upper end portion of the rod 227' so that whole upper end portion of the rod 227' fits inside the groove when the rod 227' is pushed fully, and it is also preferable for the supporting member 226' to be integrated with the rod when the rod 227' is pushed fully to prevent the rod 227' from being moved backward.
  • a mixing improvement member 222' may be used for such syringe system too.
  • Fig. 9 shows operational procedures of the syringe system of Fig. 6.
  • the operational procedures of transferring the solvent to the drug containing portion 221' and mixing the drug and the solvent are same with the procedure shown in Fig. 5.
  • the rod 227' is inserted into the syringe 220', then the supporting member 226' together with the rod 227' is pushed in the direction shown in second drawing of Fig. 9 to transfer the mixed drug suspension to the solvent containing portion 221'.
  • the mixed drug can be administered after removing the Luer lock sheath 231' and fitting the needle.
  • the whole syringe 220' functions as a rod.
  • Figs. 10 to 14 illustrate syringe system for administering drug in accordance with a third embodiment of the present invention, in which the drug container is a type of tube 310.
  • the tube 310 is sealed by a plunger 313, thereby defining a drug containing portion 311.
  • One end of the plunger 313 faces with the drug containing portion 311, and at the other end of the plunger 313, a receptor for syringe 320 is formed.
  • a mixing improvement member 312 may be inserted in the drug containing portion 311 to assist the mixing of the drug and the solvent.
  • the syringe 320 includes a barrel 325; a solvent containing portion 321; a plunger 323 sealing the solvent containing portion 321 and slidable in a lengthwise direction thereof; a needle 328 fitted to a lower end portion of the barrel 325; a rod 327 inserted into an upper end portion of the plunger 323 to move the plunger 323; and a supporting member 326 provided at an upper end portion of the barrel 325 to support the operation of the rod 327.
  • a fixing member 326' may be arranged above the supporting member 326 to fix the supporting member 326 thereto.
  • the needle 328 of the syringe 320 may be protected by a needle protection cap 329.
  • the drug containing portion 321 may be provided with a mixing improvement member 322 to assist the mixing of the drug and the solvent.
  • the supporting member 326 may be modified variously, it is preferable that a supported portion of the supporting member 322 is disposed in the middle portion of the barrel 325, as shown in Fig. 12, so that it is easy to grasp the lower end surface of the tube 310 with a thumb and the supporting member 322 with index and middle fingers, rather than the supported portion is outwardly extended at a wing portion of the upper end portion of the barrel of conventional syringes.
  • the needle 328 of the syringe 320 may be protected by a needle protection cap 329.
  • Figs. 13 and 14 show operational procedures of the syringe system of Fig. 10 se- quentially.
  • the syringe 320 is fitted to a syringe receptor 314 of the tube 310 filled with the solvent while the needle 328 penetrates to the drug containing portion 311 filled with the drug and the mixing improvement member 312.
  • the solvent is transferred to the drug containing portion 311 while pushing the plunger 313 in the tube 310 to the upper end direction of the tube 310.
  • the syringe system is then agitated in lengthwise direction thereof to mix the drug and the solvent.
  • the optionally used mixing improvement member 312 is reciprocally moved within the drug containing portion 311 during such agitation, thereby evenly dispersing the drug throughout the solvent in a short period of time.
  • the mixed suspension then is transferred to the inside of the syringe 320 by pushing the lower end of the tube 310 and the supporting member 326 in the directions shown in the third drawing of Fig. 13 respectively while pushing the plunger 323 backward.
  • the syringe 320 is removed from the tube.
  • the mixed suspension is separated into a drug layer and a solvent layer due to the difference of specific gravity during storage in the mixed state, the drug is transferred to the drug containing portion 311 to make the suspension again, then the suspension is transferred back to the syringe 320 for the administration.
  • Method for transferring the drug suspension after mixing the drug and solvent to the syringe differs from the conventional method.
  • the conventional method e.g., a vial method
  • the whole tube is depressed toward the syringe to inject the mixed drug suspension as shown in the third drawing of Fig. 13. Therefore, most of the drug suspension can be transferred even in the case that the viscosity of the solvent is high or the viscosity of the mixed suspension is increased more than that of the solvent.
  • the syringe system in accordance with the third embodiment of the present invention may be applicable to administration of a multidose formulation if the drug and the solvent are prefilled sufficient enough in an amount of two times of administration or more.
  • the mixed suspension obtained from evenly mixing the drug and the solvent in the drug containing portion of the drug container is transferred after inserting the needle into the drug container, only a predetermined amount of the mixed suspension is transferred to the syringe and then the syringe is removed from the drug container.
  • another syringe is fitted to the drug container, thereby enabling multiple administration of the drug.
  • the drug container for use in the syringe system in accordance with third embodiment of the present invention may be used for storing the drug suspension that is guaranteed for long term stability. That is, the stored drug suspension in the drug container is capable of being drawn up by fitting the syringe thereto right before administration. In this case, it is also applicable to administer the multidose formulation.
  • the syringe system in accordance with the present invention has simpler mixing procedures than the conventional vial method, and can minimize waste of the drug.
  • the mixed suspension drug is transferred to the syringe according to the vial method, much of air can be introduced into the syringe if the needle is not immersed in the mixed drug. Accordingly, it is very important to control the depth of the needle in the vial. Further, in case that the mixed suspension is not transparent, operators can not determine the depth of the needle immersed in the mixed drug, thereby requiring high skill.
  • the needle of the syringe system according to the present invention is inserted into the solvent or drug container with a fixed depth when assembling the syringe and the solvent or drug container. Accordingly, it can be used for beginners, and is safe so as to prevent needle accident and contamination.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un système de seringue qui comporte une seringue ayant une chambre, une première unité d'étanchéité destinée à étanchéifier une partie supérieure de la chambre et pouvant coulisser à l'intérieur de la chambre, et une partie contenant de médicament définie par la chambre et la première unité d'étanchéité et contenant un médicament; et un contenant de solvant comportant une chambre, une seconde unité d'étanchéité pour étanchéifier une partie supérieure de la chambre et pouvant coulisser à l'intérieur de la chambre, une partie contenant de solvant définie par la chambre et la seconde unité d'étanchéité et contenant un solvant, et un récepteur de seringue placé à proximité d'un côté supérieur de la seconde unité d'étanchéité. La seringue peut être en communication fluidique avec le contenant de solvant par adaptation dans le récepteur de seringue et pénétration du second élément d'étanchéité.
PCT/KR2008/006553 2007-11-08 2008-11-07 Système de seringue et contenant de médicament Ceased WO2009061140A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2007-0113789 2007-11-08
KR1020070113789A KR101439466B1 (ko) 2007-11-08 2007-11-08 약물 주사 장치 및 약물 주사용 키트

Publications (2)

Publication Number Publication Date
WO2009061140A2 true WO2009061140A2 (fr) 2009-05-14
WO2009061140A3 WO2009061140A3 (fr) 2009-08-06

Family

ID=40626344

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2008/006553 Ceased WO2009061140A2 (fr) 2007-11-08 2008-11-07 Système de seringue et contenant de médicament

Country Status (5)

Country Link
KR (1) KR101439466B1 (fr)
AR (1) AR069196A1 (fr)
CL (1) CL2008003297A1 (fr)
TW (1) TW200930426A (fr)
WO (1) WO2009061140A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9333147B2 (en) 2010-08-09 2016-05-10 Arte Corporation Device for sealing a vessel and method of manufacturing a sealed vessel
US11090375B2 (en) 2014-01-21 2021-08-17 Pfizer Inc. Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190298935A1 (en) * 2016-12-02 2019-10-03 Novo Nordisk A/S A prefilled injection device with cleaning chamber
KR102067941B1 (ko) * 2019-09-18 2020-01-20 송치훈 플런저의 후진을 보조하는 주사기
CN112755330A (zh) * 2021-01-19 2021-05-07 中国人民解放军联勤保障部队第九二七医院 一种用于蛇咬伤紧急救治的快速自行封闭针

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4317446A (en) * 1980-09-04 1982-03-02 Schering Corporation Prefilled disposable syringe
US5586975A (en) * 1994-02-18 1996-12-24 Takeda Chemical Industries. Ltd. Air and liquid tight container with a slidable gasket
DE19912322A1 (de) * 1999-03-19 2000-09-28 Vetter & Co Apotheker Spritze für medizinische Zwecke
FR2799654B1 (fr) * 1999-10-13 2002-01-11 Sod Conseils Rech Applic Dispositif pour reconstituer une solution, une suspension ou une dispersion therapeutique et procede de preparation et de conditionnement dans ce dispositif
JP4112851B2 (ja) * 2001-11-27 2008-07-02 テルモ株式会社 ２室型プレフィルドシリンジ

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9333147B2 (en) 2010-08-09 2016-05-10 Arte Corporation Device for sealing a vessel and method of manufacturing a sealed vessel
US11090375B2 (en) 2014-01-21 2021-08-17 Pfizer Inc. Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof
US11160855B2 (en) 2014-01-21 2021-11-02 Pfizer Inc. Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof
US11872274B2 (en) 2014-01-21 2024-01-16 Pfizer Inc. Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof

Also Published As

Publication number Publication date
AR069196A1 (es) 2010-01-06
CL2008003297A1 (es) 2009-06-12
KR20090047769A (ko) 2009-05-13
WO2009061140A3 (fr) 2009-08-06
KR101439466B1 (ko) 2014-09-15
TW200930426A (en) 2009-07-16

Similar Documents

Publication Publication Date Title
EP1225938B1 (fr) Carpule de medicament et dispositif d'injection
US3826260A (en) Vial and syringe combination
AU726258B2 (en) Reconstituting device for injectable medication
JP6313356B2 (ja) 薬剤再構成系
JP6199483B2 (ja) インライン乾燥薬剤モジュールを有するバイアルアダプタを備える医療用デバイス
US4792329A (en) Multi-compartment syringe
US5364387A (en) Drug access assembly for vials and ampules
FI92467B (fi) Menetelmä ja laite injektointia varten
JPH01131671A (ja) 注射器並びに注射器の組立て方法
US3527216A (en) Hypodermic syringe assembly
JP2009504523A (ja) バイパスを備えていないデュアルチャンバ型容器
EP1044697A1 (fr) Seringue à usage unique
WO2009061140A2 (fr) Système de seringue et contenant de médicament
CA2844127A1 (fr) Obturateur/piston pour carpules d'ensemble seringue-carpule
US9375385B2 (en) Pre-filled active vial having integral plunger assembly
US20140124514A1 (en) Method and apparatus for adding buffers and other substances to medical cartridges
US11878157B2 (en) Syringe-connector device for the separate administration of controlled quantities at least two products in a single injection
WO2025106336A1 (fr) Prévention de colmatage de dispositifs d'administration à aiguille
TW202019505A (zh) 預充填注射裝置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08847088

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 08847088

Country of ref document: EP

Kind code of ref document: A2