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
  • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
  • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/20—Gaseous substances, e.g. vapours
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/20—Targets to be treated
  • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
• • 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
  • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
  • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
  • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting

Definitions

• Administration system comprising an administration device and a protection device provided with a closure membrane
• the present invention relates to an administration system comprising an administration device and a protection device configured to at least partially protect a connection end piece of the administration device.
• connection end piece comprising a tubular connection part intended for the passage of a fluid, and a locking sleeve surrounding the tubular connection part and comprising an internal thread
• a protection device at least partially delimiting an internal chamber in which the connection endpiece at least partially extends, the protection device comprising:
• a protective part which is separably connected to the administration device, the protective part covering at least partially and protecting at least partially the connection end piece,
• a coupling part rotatably coupled to the protective part and to the shutter part so that a rotation of the protective part about an axis of rotation substantially parallel to a longitudinal axis of the part of tubular connection causes rotation of the closure part and release of the free end of the tubular connection part
• Such a configuration of the administration system makes it possible in particular to expose the connection end piece of the administration device to a sterilization gas, such as steam, and therefore to effectively sterilize the administration device. .
• the administration system in order to overcome this problem, it is known to arrange the administration system in a package, such as a blister pack provided with at least one wall permeable to sterilization gas.
• a package such as a blister pack provided with at least one wall permeable to sterilization gas.
• the presence of such packaging implies an additional opening step for the user.
• the present invention aims to remedy all or part of these drawbacks.
• the technical problem underlying the invention therefore consists in providing an administration system which is simple and economical in structure, while allowing optimal sterilization of the administration device and while guaranteeing the sterility of the connection nozzle. of the administration device.
• an administration system comprising:
• connection end piece comprising a tubular connection part intended for the passage of a fluid
• a protection device at least partially delimiting an internal chamber in which the connection endpiece at least partially extends, the protection device comprising:
• a protective part which is separably connected to the administration device, the protective part covering at least partially and protecting at least partially the connection end piece,
• a coupling part rotatably coupled to the protective part and to the shutter part so that a rotation of the protective part about an axis of rotation substantially parallel to a longitudinal axis of the part of tubular connection causes rotation of the closure part and release of the free end of the tubular connection part
• the coupling part is separate from the protection part, in that the at least one passage orifice is provided on the coupling part and in that the protection device further comprises a membrane closure extending at least partially over the coupling part and covering at least partially the at least one passage orifice.
• the administration system may further exhibit one or more of the following characteristics, taken alone or in combination.
• the at least one passage orifice is intended for the passage of a sterilization gas
• the closure membrane is porous and permeable to the sterilization gas.
• the closure membrane completely covers the at least one passage orifice.
• the closure membrane tightly covers the at least one passage orifice.
• the closure membrane is impermeable to the fluid.
• the closure membrane is located upstream of the at least one passage orifice with respect to a direction of circulation of the sterilization gas through the protection device.
• the protective part at least partially surrounds the connection end piece.
• the closure membrane is impermeable to microorganisms.
• the closure membrane is made of Tyvek (registered trademark) or of porous paper and permeable to a sterilization gas.
• connection end piece comprises a locking sleeve surrounding the tubular connection part and comprising an internal thread.
• the at least one passage orifice opens into the internal chamber opposite an annular volume delimited by the locking sleeve and the tubular connection part.
• the closure membrane at least partially covers the coupling part.
• the closure membrane bears against the coupling part.
• the protection device comprises a plurality of distributed orifices, and for example regularly distributed, around the longitudinal axis of the tubular connection part.
• the closure membrane is substantially planar.
• the closure membrane is fixed to the protective part and / or to the coupling part, for example by heat sealing.
• the coupling part comprises first rotating coupling means configured to cooperate with second rotating coupling means provided on the protective part.
• the first rotary coupling means comprise a plurality of coupling projections provided on the coupling part and angularly offset from one another
• the second rotary coupling means comprise a plurality of coupling notches provided on the protective part and angularly offset from each other.
• the coupling projections extend substantially radially with respect to the longitudinal axis of the tubular connection part.
• the coupling part comprises a central coupling housing in which the closure part is mounted.
• the central coupling housing and the closure part each have a non-circular, for example hexagonal, cross section.
• the passage orifices are distributed around the central coupling housing.
• the coupling part and the shutter part are in one piece.
• the coupling part and the sealing part are formed by an insert interposed between the protective part and the connection end piece, and for example mounted on the protective part.
• the insert may for example be made of elastomer.
• the protective part includes an internal housing in which the coupling part is arranged.
• the coupling part comprises a first surface facing the administration device and a second surface opposite the first surface
• the protective part comprising an annular fixing surface which extends around the second surface of the coupling part and which is substantially coplanar with the second surface of the coupling part, the closure membrane partially extending over the second surface of the coupling part and partially over the surface ring fixing.
• the second surface of the coupling part extends substantially perpendicular to the longitudinal axis of the tubular connection part.
• the closure part is connected by a breakable zone to the free end of the tubular connection part of the connection end piece.
• the breakable zone between the tubular connection part and the closure part is produced by an annular thinning of the material along the connection line between the free end of the tubular connection and the sealing part.
• the coupling part is coupled in rotation to the protective part and to the shutter part so that a rotation of the protective part around the axis of rotation causes a rotation of the closure part and a rupture of the breakable zone.
• the protection device comprises drive ribs formed on an external surface of the protection part, each drive rib extending substantially parallel to the longitudinal axis of the protection part. tubular connection.
• the protective part comprises a protective sleeve connected by a breakable connecting portion to the administration device.
• the protective sleeve is coaxial with the tubular connection part.
• the coupling part is rotatably coupled to the protective part and to the sealing part so that a rotation of the protective part around the axis of rotation also causes the breakable link portion to break.
• the breakable connecting portion connects the protective sleeve to a body of the administration device from which the connection end protrudes.
• the protective sleeve surrounds the locking sleeve.
• the breakable connecting portion connects the protective sleeve to a free end of the locking sleeve.
• the breakable connection portion comprises a plurality of breakable connection tabs angularly spaced from one another relative to the longitudinal axis of the tubular connection part.
• each connecting lug is substantially aligned longitudinally with a respective drive rib.
• the breakable connecting portion is annular.
• the breakable connection portion between the protective sleeve and the administration device is produced by an annular thinning of the material along the connection line between the protective sleeve and the device. of Directors.
• the breakable connecting portion comprises a tearable strip connecting the protective sleeve to the administration device, and more particularly to the body of the administration device.
• the tearable strip has a gripping tab.
• each drive rib is provided on an external surface of the protective sleeve.
• the at least one passage orifice opens out opposite an annular volume delimited by the locking sleeve and the protective sleeve.
• the coupling part comprises an external coupling surface configured to cooperate, for example by friction, with an internal surface of the protective sleeve, and an internal coupling surface configured to cooperate , for example by friction, with an external surface of the locking sleeve.
• the external coupling surface of the coupling part forms the first rotation coupling means
• the internal surface of the protective sleeve forms the second rotation coupling means.
• the coupling part comprises at least one annular sealing rib provided on the internal coupling surface and configured to cooperate in leaktight manner with the external surface of the locking sleeve.
• the coupling part extends in the annular volume delimited by the locking sleeve and the protective sleeve.
• the coupling part comprises an anchoring part configured to cooperate with the internal thread of the locking sleeve so as to block in translation the coupling part relative to the administration device .
• the anchoring part is configured to allow the coupling part to be unscrewed relative to the connection end piece.
• the shutter part comprises a shutter portion sealingly closing the free end of the tubular connection part of the connection end piece, and an annular sealing portion configured to cooperate sealingly with an external surface of the tubular connection part.
• the protective part comprises a tubular wall projecting away from the administration device.
• the tubular wall is coaxial with the tubular connection part.
• the protective sleeve has an external diameter substantially equal to the external diameter of the body of the administration device.
• the protective sleeve could have an external diameter less than the external diameter of the body of the administration device, and an internal diameter greater than or equal to the internal diameter of the locking sleeve.
• the outer diameter of the protective sleeve can be greater than the outer diameter of the locking sleeve.
• the closure part is made of elastomer.
• the shutter part comes from material, and in particular comes from molding, with the connection end piece.
• the coupling part is made of plastic and for example polypropylene.
• the tubular connection part is frustoconical.
• the locking sleeve is coaxial with the tubular connection part.
• connection piece of the administration device is of the Luer Lock, NR-Fit or similar type.
• the protective part is tubular.
• the coupling part is tubular.
• the administration device is a pre-filled syringe.
• the administration device is an empty syringe, a vial or even an administration bag, such as an infusion bag.
• the protective part comes from material, and in particular comes from molding, with the connection end piece.
• Figure 1 is a partial perspective view of an administration system according to a first embodiment of the invention.
• Figure 2 is a partial view in longitudinal section of the delivery system of Figure 1.
• Figure 3 is a partial truncated perspective view of the delivery system of Figure 1 in which the closure membrane has been removed.
• Figure 4 is a top view of the delivery system of Figure 1 in which the closure membrane has been removed.
• Figure 5 is a partial view in longitudinal section of a delivery system according to a second embodiment of the invention.
• Figure 6 is a partial view in longitudinal section of a delivery system according to a third embodiment of the invention.
• Figure 7 is a partial truncated perspective view of the delivery system of Figure 6 in which the closure membrane has been removed.
• Figure 8 is a partial view in longitudinal section of an administration system according to a fourth embodiment of the invention.
• Figure 9 is a partial perspective view of the administration system of Figure 8.
• Figure 10 is a top view of the delivery system of Figure 8 in which the closure membrane has been removed.
• Figure 11 is a longitudinal sectional view of an administration system according to a fifth embodiment of the invention.
• FIGS. 1 to 4 represent an administration system 2 according to a first embodiment of the invention, which comprises an administration device 3 and a protection device 4 mounted on the administration device 3.
• the administration device 3 is formed by a pre-filled syringe and comprises a body 5 of generally cylindrical shape provided with a proximal end (not visible in FIGS. 1 to 4) and d 'a distal end 6.
• the internal volume of the body 5 can for example be filled with a drug solution, a solvent, or any other fluid which can be administered to a patient, or else be filled with a gas or a solid, such as a powder and in particular a lyophilized product.
• the administration device 3 also comprises a connection end piece 7 disposed at the distal end 6 of the body 5.
• the connection end piece 7 comprises a tubular connection part 8 fluidly connected to the interior volume of the body 5, and a locking sleeve 9 arranged coaxially with the tubular connection part 8 and surrounding the latter.
• the locking sleeve 9 preferably has an internal thread 11, and the tubular connection part 8 is preferably frustoconical.
• the protection device 4 comprises a protection part 12 which is tubular and which is separably connected to the administration device 3.
• the protection part 12 at least partially delimits an internal chamber 13 in which the connection end piece at least partially extends 7.
• the protective part 12 at least partially covers and at least partially protects the connection end piece 7.
• the protective part 12 comprises a protective sleeve 14 which surrounds the locking sleeve 9 and which is connected to the administration device 3, and more particularly to the body 5 of the administration 3, by a breakable connection portion 15.
• the breakable connection portion 15 may be annular and be produced for example by an annular thinning of the material along the connection line between the protective sleeve 14 and the body 5 of the administration device 3.
• the protective sleeve 14 is advantageously coaxial with the tubular connection part 8, and has for example an internal diameter greater than the external diameter of the locking sleeve 9 and less than the external diameter of the body 5.
• the protection device 4 further comprises a shutter part 16 sealing the free end of the tubular connection part 8 of the connection end piece 7.
• the part obturation 16 comes integrally with the connection end piece 7, and is connected by a breakable zone 17 to the free end of the tubular connection part 8 of the connection end piece 7.
• the breakable zone 17 can for example be produced by an annular thinning of the material along the connection line between the free end of the tubular connection part 8 and the closure part 16.
• the protective device 4 also comprises a coupling part 18 disposed in an internal housing 19 delimited by the protective part 12, and more particularly by the protective sleeve 14.
• the coupling part 18 can for example be made of plastic material and in particular polypropylene.
• the coupling part 18 has the general shape of a disc, and has a first surface 18.1 facing the administration device 3 and a second surface 18.2 which is opposite the first surface. 18.1 and which is substantially planar.
• the second surface 18.2 of the coupling part 18 extends substantially perpendicular to the longitudinal axis A of the tubular connection part 8, and the protective part 12 comprises an annular fixing surface 21 which extends around of the second surface 18.2 of the coupling part 18 and which is substantially coplanar with the second surface 18.2.
• the coupling part 18 is separate from the protective part 12, and comprises several coupling projections 22 (see FIGS. 3 and 4) offset angularly from one of the others with respect to the longitudinal axis A and configured to cooperate with coupling notches 23 provided on the protective part 12 and angularly offset from one another with respect to the longitudinal axis A.
• the projections d coupling 22 extend substantially radially with respect to the longitudinal axis A.
• the coupling part 18 further comprises a central coupling housing 24 in which the shutter part 16 is mounted.
• the central coupling housing 24 and the shutter portion 16 each have a non-circular, for example hexagonal, cross section.
• the coupling part 18 is thus coupled in rotation to the protective part 12 and to the sealing part 16 so that a rotation of the protective part 12, and more particularly of the protective sleeve 14, around d an axis of rotation parallel to the longitudinal axis A of the tubular connection part 8 causes rotation of the closure part 16 and a rupture on the one hand of the breakable connecting portion 15 and on the other hand of the breakable zone 17.
• the protective device 4 also comprises several passage orifices 25 provided on the coupling part 18 and opening into the internal chamber 13.
• Each passage orifice 25 is more particularly intended for the passage of a sterilization gas which can for example be water vapor or ethylene oxide.
• the passage orifices 25 are regularly distributed around the central coupling housing 24, and therefore regularly distributed around the longitudinal axis A of the tubular connection part 8.
• each passage orifice 25 opens into the internal chamber 13 at least partially opposite an annular volume 26 (see FIG. 3) delimited by the locking sleeve 9 and the tubular connection part 8.
• each orifice passage 25 could also lead into the internal chamber 13 at least partially opposite an annular volume delimited by the locking sleeve 9 and the protective sleeve 14.
• the protection device 4 further comprises a closure membrane 27 which is substantially planar and which is located upstream of the passage orifices 25 relative to a direction of circulation of the sterilization gas through the protection device 4.
• the membrane closure 27 is porous and permeable to sterilization gas.
• the closure membrane 27 is impermeable to microorganisms, and is for example made of Tyvek (registered trademark).
• the closure membrane 27 covers the coupling part 18 and in particular the passage orifices 25, and is fixed to the annular fixing surface 21 of the protective part 12.
• the protection device 4 also comprises several drive ribs 28 which extend parallel to the longitudinal axis A of the tubular connection part 8, and which are formed on a surface of the protective part 12, and more particularly of the protective sleeve 14.
• Such drive ribs 28 facilitate the rotational driving of the protective part 12 by a user, and also prevents the latter from attempting to separate the protection device 4 of the administration device 3 by traction or bending.
• the drive ribs 28 are regularly distributed around the longitudinal axis A.
• the protective device 4 could be devoid of the drive ribs 28.
• FIG. 5 shows a delivery system 2 according to a second embodiment of the invention which differs from the first embodiment shown in Figures 1 to 4 essentially in that the breakable connecting portion 15 connects the protective sleeve 14 at a free end of the locking sleeve 9.
• the protective sleeve 14 has an internal diameter corresponding substantially to the internal diameter of the locking sleeve 9.
• Figures 6 and 7 show a delivery system 2 according to a third embodiment of the invention which differs from the second embodiment shown in Figure 5 essentially in that the protective part 12 comprises a tubular wall 29 which projecting opposite the administration device 3 and which is coaxial with the protective sleeve 14.
• the tubular wall 29 projects relative to the closure membrane 27.
• FIGS. 8 to 10 represent a delivery system 2 according to a fourth embodiment of the invention which differs from the first embodiment shown in FIGS. 1 to 4 essentially in that the protection device 4 comprises an insert 31, for example made of elastomer, fixed to the protective part 12 and forming the coupling part 18 and the closure part 16.
• the coupling part 18 and the part shutter 16 are in one piece.
• the breakable connection portion 15 comprises a plurality of breakable connection tabs 32 angularly spaced from one another relative to the longitudinal axis A of the tubular connection part 8
• each link tab 32 is substantially aligned longitudinally with a respective drive rib 28.
• the coupling part 18 extends in an annular volume delimited by the locking sleeve 9 and the protective sleeve 14, and comprises an external coupling surface 33.1 configured to cooperate, for example by friction, with an internal surface of the protective sleeve 14, and an internal coupling surface 33.2 configured to cooperate, for example by friction, with an external surface of the locking sleeve 9.
• the part coupling 18 comprises several annular sealing ribs 30 provided on the internal coupling surface 33.2 and offset along the longitudinal axis A of the tubular connection part 8. Such annular sealing ribs 30 are configured to cooperate tightly with the external surface of the locking sleeve and thus form a sterile barrier which prevents the passage of impurities towards the free end of the connection piece 7.
• the fourth embodiment of the invention differs from the first embodiment of the invention also in that the closure part 16 comprises a closure portion 16.1 sealingly closing the free end of the tubular connection part 8 of the connecting piece 7, and an annular sealing portion 16.2 which extends along an external surface of the tubular connecting part 8, the annular sealing portion 16.2 being configured to cooperate in leaktight manner with the external surface of the tubular connection part 8.
• Figure 11 shows a delivery system 2 according to a fifth embodiment of the invention which differs from the first embodiment shown in Figures 1 to 4 essentially in that the breakable connecting portion 15 comprises a tearable strip 34 connecting the protective sleeve 14 to the administration device 3, and more particularly to the body 5 of the administration device 3.
• the tearable strip 34 comprises a gripping tongue 35.
• the coupling part 18 further comprises an anchoring part 36 configured for cooperate with the internal thread 11 of the locking sleeve 9 so as to block in translation the coupling part 18 relative to the administration device 3.
• the anchoring part 36 protrudes towards the administration device 3 and is configured to allow the coupling part 18 to be unscrewed relative to the connection end piece 7.
• the anchoring part 36 may for example be formed by several anchoring tongues 37 extending substantially parallel to the longitudinal axis A of the tubular connection part 8, the anchoring tabs being distributed around the tubular connection part 8.
• the closure part 16 could be separate from the coupling part 18 and from the connection end piece 7, be made of elastomer and be attached and fixed to the coupling part 18 so as to be coupled in rotation to the latter.
• the sterilization step of the administration device can be carried out by irradiation, and in particular by irradiation with gamma or beta rays.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Heart & Thoracic Surgery (AREA)
• Anesthesiology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Epidemiology (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=65031520

Family Applications (1)

Country Status (7)

Cited By (2)

Families Citing this family (3)

Family Cites Families (11)

• 2018
  • 2018-07-27 FR FR1857000A patent/FR3084263B1/fr active Active
• 2019
  • 2019-07-24 CA CA3106141A patent/CA3106141A1/fr active Pending
  • 2019-07-24 US US17/263,478 patent/US20210162141A1/en not_active Abandoned
  • 2019-07-24 EP EP19761918.2A patent/EP3829681A1/de not_active Withdrawn
  • 2019-07-24 WO PCT/FR2019/051838 patent/WO2020021201A1/fr unknown
  • 2019-07-24 CN CN201980064034.8A patent/CN112770799B/zh active Active
  • 2019-07-24 JP JP2021504250A patent/JP2021531126A/ja not_active Ceased

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