WO2008110890A1 - Dispositif d'administration d'un produit - Google Patents

Dispositif d'administration d'un produit Download PDF

Info

Publication number
WO2008110890A1
WO2008110890A1 PCT/IB2008/000535 IB2008000535W WO2008110890A1 WO 2008110890 A1 WO2008110890 A1 WO 2008110890A1 IB 2008000535 W IB2008000535 W IB 2008000535W WO 2008110890 A1 WO2008110890 A1 WO 2008110890A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrel
product
foregoing
closing
administering
Prior art date
Application number
PCT/IB2008/000535
Other languages
English (en)
Inventor
Gianpaolo Belloli
Original Assignee
Gianpaolo Belloli
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 Gianpaolo Belloli filed Critical Gianpaolo Belloli
Priority to EP08719246A priority Critical patent/EP2121085A1/fr
Publication of WO2008110890A1 publication Critical patent/WO2008110890A1/fr

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
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • 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
    • 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
    • A61M2005/3121—Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
    • 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
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A61M5/003—Kits for diabetics

Definitions

  • This invention relates to a device for administering a liquid product to a user, in particular for administering a pharmaceutical product or the like.
  • Syringes for administering pharmaceutical products are known. These syringes comprise a glass barrel for containing the pharmaceutical product and a needle fixedly inserted into the glass body and used to inject a predetermined dose of the product into the patient.
  • the glass barrel is sterilized together with the predetermined product dose, with the disadvantage of a high cost, however, due to the use of glass and to the need to handle a containing barrel into which the needle has been pre-inserted.
  • An additional cost factor for syringes of this kind is the need to use suitable means, such as, for example a separate cap made of a suitable material, to close the end of the needle through which the liquid is injected.
  • these customary prefilled syringes present an additional problem when it comes to disposing of them. Indeed, since the barrel of the syringe is made of glass and the pre-inserted needle is made of metal, the syringe barrel cannot be readily disposed of in bins used for collecting waste glass. Indeed, plastic syringes with empty containing bodies are also known.
  • a needle is inserted into the end hub of the containing barrel and is used to draw product into the containing barrel and to inject the product into the patient.
  • plastic syringes are not designed to receive a product and thus to be sterilized at a high temperature in an autoclave together with the product.
  • This invention provides a device for administering a liquid product to a user, in particular a pharmaceutical product, comprising a barrel that presents a product containing space, which leads to a product outlet opening, and means for associating the containing space with means for injecting the product, the device being characterized in that it comprises means for closing the product outlet opening, said closing means being connected to the barrel through breakable connection means.
  • the invention also provides an advantageous method for making a device for administering a liquid product to a user, in particular for making a device for administering a pharmaceutical product or the like, an advantageous method for administering a liquid product to a user, in particular for administering a pharmaceutical product or the like, and an advantageous kit for administering a liquid product to a user, in particular for administering a pharmaceutical product or the like.
  • FIG. 1A is a schematic perspective view of a preferred embodiment of the device for administering a liquid product according to the invention.
  • FIG. 1B is a schematic longitudinal section view of the first preferred embodiment of the device for administering a product
  • FIGS. 2A to 2E are schematic perspective views illustrating the different steps of making the first preferred embodiment of the device for administering a liquid product according to the invention
  • FIGS. 3A to 3F are schematic perspective views illustrating the different steps in the procedure for using the first preferred embodiment of the administering device
  • - Figure 4 is a schematic perspective view of a first preferred embodiment of an administering kit comprising a first preferred embodiment of the administering device
  • - Figure 5 is a schematic perspective view of a second preferred embodiment of an administering kit comprising a second preferred embodiment of the administering device
  • FIG. 6 is a schematic perspective view of a third preferred embodiment of an administering kit comprising a third preferred embodiment of the administering device according to the invention.
  • FIG. 7 is a schematic perspective view of a fourth preferred embodiment of an administering kit comprising the third preferred embodiment of the administering device according to the invention.
  • Figures IA and IB illustrate a first preferred embodiment of a device, in particular in the form of a component or part of a syringe, for administering a liquid product to a user, in particular for administering a pharmaceutical product.
  • the device 10 comprises a cylindrical containing barrel 12 made of a suitable plastic material and having an outside surface and an inside surface 12' forming a space or chamber 14 for containing the liquid product 11 to be administered.
  • the containing space 14 leads to an outlet opening 16 through which the product 11 is transferred from the syringe to respective means, or needle, for injecting the product into the user's body and to be associated with the barrel 12 at the time of use.
  • respective means or needle
  • the needle is not illustrated in Figures IA and IB.
  • the device according to the invention comprises means for driving the product out of the barrel 12 and means for associating it, or connecting it, with respective injection means, in particular with a respective needle, as described in more detail below.
  • the product 11 outlet opening 16 is advantageously closed by suitable closing means 18 that are integrally connected to the barrel 12 through breakable connecting means, labelled 20 in the drawings.
  • the closing means or cap 18 are advantageously made of a plastic material as a single part with the barrel 12.
  • the breakable connecting means 20 are also advantageously made as a single part with the barrel 12.
  • the means for associating the needle with the product injection means comprise the outside surface 17 of a product outlet nozzle 15, and extending from the barrel 12, in particular from the end wall 12" of the barrel.
  • the head of the infusion needle is pressed over the outside surface of the nozzle 15.
  • the product outlet opening 16 opens at the free end of the nozzle 15.
  • the product nozzle 15 extends from the barrel and is conical in shape, tapering towards the free end product outlet opening 16.
  • the means 18 for closing the barrel opening 16 are embodied by a full, enlarged portion of material which is associated with the nozzle 15 at the free product outlet end 16' of the nozzle 15.
  • the closing means 18 are embodied by a full, enlarged portion that extends radially or peripherally beyond the peripheral or outside edge of the nozzle 15, at the point where it connects to the enlarged portion 18.
  • the closing portion 18 has a substantially cylindrical part 18a, from which extends a conical portion 18b which is smaller in diameter than the cylindrical portion 18a and which tapers or converges towards the portion connected to the nozzle 15.
  • the enlarged portion 18a extends radially beyond the peripheral profile of the nozzle 15, forming an area that easily attaches or connects to advantageous snap means for facilitating breakage, as described in more detail below.
  • the closing portion 18 is longitudinally aligned with the barrel and with the nozzle 15 extending therefrom.
  • the breakable connecting means 20 are embodied by at least one pre-weakened area located between the barrel 12 and the means 18 that close the product outlet opening 16.
  • the breakable connecting means 20 comprise a pre- weakened area provided at the means for association with the product injection means, and, more specifically, at the end of the nozzle 15 through which the product passes.
  • the breakable connecting means are embodied by a circumferentially thinner portion whose diameter is smaller than the outside diameter of the nozzle 15, and of the closing element 18b at the connection between the closing portion 18 and the nozzle 15.
  • the pre-weakened area 20 is obtained by reducing the thickness or diameter of the portion that extends circumferentially around the full circular profile of the nozzle 15.
  • the breakable connecting portion 20 is defined by the reduced thickness of the closing element or seal 18b and has a transversal strip 20' for delimiting and sealing the opening 16 at the end of the nozzle.
  • the nozzle 15 is sealed in such a way as to avoid damage to the nozzle when the closure 18 is removed so that the user can easily fit the injection needle head.
  • advantageous means are provided for holding or gripping the closing means 18, said gripping means comprising a first and a second radial tab 181 and 182 that are transversally or radially aligned with each other and extend from the outside surface of the enlarged cylindrical portion 18a of the closure 18.
  • the grip tabs 181, 182 have a respective flattened body 181a, 182a, with a suitably shaped profile, having a portion 181b, 182b extending transversally of the enlarged portion 18a and respective portions 181c, 182c which extend longitudinally towards the barrel 12 and which taper radially towards the centre, that is to say, converge towards the end surface 12" of the barrel.
  • the radial tabs 181, 182 extend radially beyond the peripheral edge of the cylindrical barrel 12.
  • the grip tabs 181, 182 have respective radial ends 181', 182', of reduced diameter or thickness, which connect them to the barrel 12, in particular to the outside surface of the nozzle 15 near the end 12" of the barrel, and which define respective breakable means for connection to the barrel.
  • the barrel 12 has an inlet opening 22.
  • said opening is advantageously used to fill the product 11 into the barrel and to insert product drive means, such as the plunger 24 for example, into the barrel.
  • the device according to the invention also advantageously comprises, at the same end as the inlet opening 22, means for closing the barrel 12 and for holding the product within.
  • the means for closing the barrel at the inlet opening end 22, comprise a stopper 24 that is pressed in in such a way that its outside circumferential surface rubs against the inside surface 12' of the barrel 12.
  • the stopper 24 constitutes means for holding the liquid product 11 within the barrel and also serves as means for driving the liquid out of the syringe.
  • the stopper 24 comprises means 28 for engaging means used for driving the liquid out, said engagement means being embodied by a central recess formed in the middle of the stopper 24, into which a suitable pin forming part of a plunger rod, not illustrated in Figures IA and IB, can be inserted.
  • the recess 28 for engaging the plunger rod is located on the side of the stopper 24 facing the outside of the barrel. As illustrated, at its inlet opening end 22, the barrel 12 has a widened edge
  • the film 26 has a substantially quadrangular, or rectangular, shape, while the engagement edge 121 has a curvilinear profile.
  • corner portions 26a of the sealing film 26 extend transversally beyond the corresponding portion 121' of the widened engagement edge and serve as means for facilitating the removal of the sealing film 26 from the respective end of the barrel 12.
  • the widened edge 121 has, in particular, a first and a second transversal lip 121a, 121b extending radially to a greater extent on two opposite sides of the barrel 12.
  • this provides a large surface for connection to the sealing film 26 which makes it possible, if necessary, to hold the product 11 within the barrel 12 instead of using the stopper 24 for this purpose, as shown clearly in Figure 5.
  • the retaining portion 121 has a substantially elliptic profile and extends transversally, or radially, beyond the peripheral edge of the barrel 12, with the lips 121a, 121b substantially aligned with the grip tabs 181, 182 of the closing means 18 at the product outlet end.
  • the invention provides a device for administering a liquid 11, which contains said liquid in a prefilled and sterilized condition, and which is provided with suitable means for closing the outlet end 16 and the inlet end 22, and where the means for closing the barrel at the outlet end are advantageously in the form of breakable means.
  • Figures 2 A to 2E illustrate a method for making a device for administering a liquid product to a user, in particular a pharmaceutical product.
  • the method comprises the step of preparing a barrel 12 of the type described above, that is to say, having means for closing or sealing a liquid outlet opening which are connected to the barrel by breakable means that can be snapped off at the liquid outlet opening 16 and comprising means 17 for association with respective injection means, the liquid outlet opening 16 being located at the end of said association means.
  • the barrel 12 has a chamber, or space, 14 for containing the product and an opening 22 which communicates with the containing chamber or space 14 and through which the product 11 is filled, as shown in Figure 2B.
  • means 24, 26 for closing the product containing space 14 are placed, as illustrated in Figures 2C, 2D and 2E and the barrel 12 with the product 11 in it is sterilized at a high temperature in a suitable autoclave.
  • sterilization is performed after the means 24, 26 for closing the product containing space 14 have been placed.
  • an empty barrel having the characteristics described above, labelled 12 is filled with liquid 11 by suitable means 30 through the inlet opening 22, as illustrated in Figure 2B.
  • a stopper 24 is inserted into the opening 22 to serve both as means for closing the barrel 12 and as a plunger for driving the liquid out, and lastly, as illustrated in Figures 2D and 2E, a film or membrane 26 is applied to the transversal tabs 121a, 121b at the top of the barrel
  • FIGS 3A to 3F illustrate an advantageous method for administering a liquid product to a user, in particular for administering a pharmaceutical product or the like.
  • the injection means or needle 40 comprise a head 41 that is applied to the outside surface 17 of the product outlet nozzle 15 extending from the barrel 12 and having at the end of it a product outlet opening 16 from which the closing element 18 was previously separated.
  • FIGS. 4 to 7 illustrate different kits for administering a liquid product to a user, in particular for administering a pharmaceutical product.
  • a first embodiment 50 of the kit comprises a container 52 consisting of a base, made preferably of rigid or semi-rigid plastic, and a top sealing film 54 that cooperates with the widened edge 53 of the container 52.
  • the kit comprises an administering device embodied by a prefilled barrel 12, as described above, in closed or sealed condition, a plunger rod 44, packed in a respective bag 44', and a needle holder cap 43, packed in a respective bag 43', containing a needle which is not shown in Figure 4.
  • Figure 5 shows a second preferred embodiment 150 of the administering kit, comprising a container 52, 54 identical to the one of the first embodiment and therefore not described again.
  • the second kit embodiment comprises an administering device 110 having a barrel 112 prefilled with product, a plunger rod 144, packed in a respective bag 44' and prefitted with a plunger 24 for driving the liquid 11.
  • the administering device 110 is the same as the device 10 described above, differing only in that the stopper/plunger 24 is not pre- inserted into the barrel 112.
  • the means for closing the opening 22 are therefore constituted by the film 26 alone.
  • Figure 6 illustrates a third preferred embodiment 250 of the kit for administering a liquid product, in particular for administering a pharmaceutical product.
  • the third embodiment comprises an administering device 222 having a barrel prefilled with the liquid to be administered, where the liquid is held within the barrel 12 solely by the stopper/plunger 24 with the plunger rod 44 already fitted to it being preinserted into the plunger/stopper 24 inside the barrel 12 and extending longitudinally outside the barrel.
  • the third embodiment also comprises a needle holder cap 43, containing a needle and packed in a respective bag 43'.
  • This third kit is a package comprising a container 152 consisting of a base, made preferably of rigid or semi-rigid plastic and provided with a top sealing film 154 applied to the widened edge 153 of the container base.
  • the container 152, 154 is smaller in size than the containers of the first and second kit embodiments 50, 150 described above.
  • a fourth preferred kit 350 for administering a liquid product to a user in particular for administering a pharmaceutical product or the like, comprises an administering device 222 having the same characteristics as the third preferred embodiment and is not described again.
  • the device 222 of the fourth preferred kit embodiment is housed in a container 352 which is even smaller since it does not include an injection needle and which also consists of a container base 352, made preferably of rigid or semirigid plastic and provided with a top sealing film 354 applied to the widened edge 353 of the container base.
  • kits for easily administering a liquid product, in particular a pharmaceutical product or the like to a user are provided.
  • the body of the device is made preferably of a plastic material, especially a rigid plastic material, that is resistant to high temperatures.

Abstract

L'invention concerne un dispositif (10) servant à administrer un produit liquide à un utilisateur, en particulier un produit pharmaceutique. Ledit dispositif comprend un récipient (12) formé d'un espace (14) destiné à contenir un produit (11), associé à une ouverture de sortie de produit et pourvu de moyens d'entraînement du produit hors du récipient (12) et de moyens destinés à associer ledit produit à des moyens d'injection de produit. Le dispositif comprend des moyens (18) de fermeture de l'ouverture (16) de sortie du produit, lesdits moyens (18) de fermeture étant connectés au récipient (12) à l'aide de moyens (20) de connexion cassables.
PCT/IB2008/000535 2007-03-12 2008-03-07 Dispositif d'administration d'un produit WO2008110890A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08719246A EP2121085A1 (fr) 2007-03-12 2008-03-07 Dispositif d'administration d'un produit

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITBO2007A000166 2007-03-12
ITBO20070166 ITBO20070166A1 (it) 2007-03-12 2007-03-12 Dispositivo per la somministrazione di un prodotto.

Publications (1)

Publication Number Publication Date
WO2008110890A1 true WO2008110890A1 (fr) 2008-09-18

Family

ID=39668123

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/000535 WO2008110890A1 (fr) 2007-03-12 2008-03-07 Dispositif d'administration d'un produit

Country Status (3)

Country Link
EP (1) EP2121085A1 (fr)
IT (1) ITBO20070166A1 (fr)
WO (1) WO2008110890A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10675280B2 (en) 2001-10-20 2020-06-09 Sprout Pharmaceuticals, Inc. Treating sexual desire disorders with flibanserin
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0737485A1 (fr) * 1993-12-28 1996-10-16 HIGASHIKAWA, Tetsuro Seringue
DE19925621A1 (de) * 1998-06-16 1999-12-23 Buelent Yilmaz Injektionsspritze
FR2781145A1 (fr) * 1998-07-15 2000-01-21 Cediat Mediffusion Ensemble kit destine a pratiquer une injection de medicament et a collecter les elements du kit apres leur utilisation
WO2001043799A1 (fr) * 1999-12-14 2001-06-21 Biodome Seringue pre-remplie et son procede de fabrication
WO2001054755A1 (fr) * 2000-01-25 2001-08-02 Protective Shield Limited Systeme de distribution et son appareil
WO2004075955A1 (fr) * 2003-02-25 2004-09-10 Jean-Denis Rochat Dispositif et procede de conditionnement d’un medicament et de prise de sang

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0737485A1 (fr) * 1993-12-28 1996-10-16 HIGASHIKAWA, Tetsuro Seringue
DE19925621A1 (de) * 1998-06-16 1999-12-23 Buelent Yilmaz Injektionsspritze
FR2781145A1 (fr) * 1998-07-15 2000-01-21 Cediat Mediffusion Ensemble kit destine a pratiquer une injection de medicament et a collecter les elements du kit apres leur utilisation
WO2001043799A1 (fr) * 1999-12-14 2001-06-21 Biodome Seringue pre-remplie et son procede de fabrication
WO2001054755A1 (fr) * 2000-01-25 2001-08-02 Protective Shield Limited Systeme de distribution et son appareil
WO2004075955A1 (fr) * 2003-02-25 2004-09-10 Jean-Denis Rochat Dispositif et procede de conditionnement d’un medicament et de prise de sang

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10675280B2 (en) 2001-10-20 2020-06-09 Sprout Pharmaceuticals, Inc. Treating sexual desire disorders with flibanserin
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

Also Published As

Publication number Publication date
EP2121085A1 (fr) 2009-11-25
ITBO20070166A1 (it) 2008-09-13

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