WO2011023748A1 - Réservoir pour une seringue - Google Patents

Réservoir pour une seringue Download PDF

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Publication number
WO2011023748A1
WO2011023748A1 PCT/EP2010/062451 EP2010062451W WO2011023748A1 WO 2011023748 A1 WO2011023748 A1 WO 2011023748A1 EP 2010062451 W EP2010062451 W EP 2010062451W WO 2011023748 A1 WO2011023748 A1 WO 2011023748A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
syringe container
shrink tube
sleeve
container according
Prior art date
Application number
PCT/EP2010/062451
Other languages
German (de)
English (en)
Inventor
Dirk-Henning Menz
Yong Keun Kim
Original Assignee
Pharmpur Gmbh
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42988346&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2011023748(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pharmpur Gmbh filed Critical Pharmpur Gmbh
Publication of WO2011023748A1 publication Critical patent/WO2011023748A1/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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a 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
    • A61M5/32—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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

Definitions

  • the invention relates to a syringe container for a syringe according to the preamble of claim 1.
  • a generic syringe container is known from US 6027482. Therein is described a syringe having a cylindrical syringe container, wherein the syringe container encloses a chamber which serves to receive a substance, such as a pharmaceutically used liquid. At a distal end of the cylindrical syringe container, a tip is arranged through which passes a passage. At the top of a connection arrangement for connecting the syringe container is arranged with a corresponding connector part, said connection arrangement comprises a sleeve which surrounds the tip concentrically. The proximal end of the cuff has an array of inwardly facing projections for frictionally engaging the outside of the tip.
  • the known syringe container is preferably made of glass, which is why the sleeve can not be integrally formed on the tip of the syringe container.
  • the sleeve is made of a thermoplastic material and mechanical attachment of the sleeve to the tip of the syringe container is required.
  • further attachment possibilities are mentioned in DE 199 56 243 A1, for example a sliding seat or a snap fit.
  • the sleeve is used in the known syringe container in particular to protect the preferably designed as a Luer-lock connector between the tip of the syringe container (which is preferably shaped as a Luer cone) and any counterpart with a corresponding counter-cone against inadvertent release of the compound and to ensure the tightness of the connection.
  • the known compounds are leaking in use or can be removed when screwing the counter cone on the syringe, the sleeve.
  • the present invention seeks to further develop a generic syringe container so that the attached to the syringe container counterpart, which has a corresponding connector assembly on the syringe container connector part, tight and tight and can solve neither uncontrolled during assembly nor in use and the cuff does not detach during assembly even by rotational movements.
  • the counterpart attached to the syringe container is as tight as possible and stable against unintentional removal, in particular even when loaded by rotation.
  • connection between the connection arrangement on the syringe container and the corresponding connector part of the counterpart should also be after a possibly required sterilization of existing from the syringe container and the counterpart arrangement or be ensured at (too) tightening the connection.
  • Fig. 1 perspective view of a generic syringe container in a
  • FIG. 2 is a cross-sectional view of the syringe container shown in FIG. 1 with the tip cap attached thereto;
  • Fig. 3 Schematic representation of a syringe container according to the invention with a shrunk in the region of the tip and the cuff
  • Fig. 4 Schematic representation of a generic syringe container with a
  • the syringe container shown in Figures 1 and 2 corresponds to the syringe barrel 12 known from US 6027482. This is made in one piece of a preferably transparent material, such as glass or plastic.
  • the syringe container 12 is a glass cylinder.
  • the syringe container has a proximal end 14, a distal end 16, and a cylindrical wall 18 extending therebetween.
  • the wall 18 surrounds a chamber 20.
  • the chamber 20 serves to receive a pharmaceutically used substance or of medical devices or medicaments.
  • the syringe container can also be used to hold other substances, in particular liquids.
  • a tip 22 is disposed on the syringe container 12.
  • the tip 22 has a passage 24 communicating with the chamber 20.
  • a piston rod assembly with a piston rod 26 and a piston 28 arranged thereon can be inserted in order to be able to push the substance located in the chamber 20 out of the syringe container 12 through the passage 24.
  • the syringe container 12 can be used as intended, as shown schematically in Figure 1, with a cannula 30, for example, to inject the substance via the piston rod assembly from the chamber 20 through the passageway 24 and via the cannula into human or animal tissue.
  • a connection arrangement for connecting the syringe container 12 to a corresponding connector part 42 provided on the cannula 30 is arranged at the tip 22.
  • it is at the top 22 of the Syringe container 12 provided connection assembly around the male part of a Luer-lock connection, which cooperates with a corresponding connector part in the form of the female part of a Luer-Lock connection.
  • the tip 22 tapers conically toward its distal end with a 6% Luer cone (preferably in accordance with the standard DIN EN 20594-1: 1993).
  • the syringe container 12 may be further sealed with a tip cap assembly 54 at its distal end 16.
  • the tip cap assembly 54 illustrated in FIGS. 1 and 2 includes an inner cap 56 and an outer cap 58, wherein the inner cap 56 may be inserted into the outer cap 58 as shown in FIG.
  • This connection arrangement comprises a collar 44 arranged concentrically around the tip 22, which is preferably made of a thermoplastic.
  • the collar 44 is formed as a luer-lock adapter.
  • the proximal end 46 of the sleeve 44 has inwardly protruding projections 50, which are frictionally seated on the outside of the tip 22 of the syringe container 12.
  • On the outer side of the tip 22 may preferably (not shown here) circumferential annular groove may be provided, in which the supernatants 50 of the sleeve 44 frictionally engage to ensure a first attachment of the sleeve 44 at the top 22 of the syringe container 12.
  • the outer cap 58 is preferably an integrally molded sleeve having a proximal end 72 and a distal end 74 and a passage 78.
  • the passage 78 is stepped therein with an inwardly projecting annular rib 80.
  • ribs 84 are provided to facilitate gripping the outer cap.
  • the inner cap 56 is inserted.
  • the inner cap 56 is preferably formed of an elastomeric plastic material which is softer than the plastic material of the outer cap 58.
  • the inner cap 56 has an undercut 70 in the region of its distal end 62.
  • inner cap 56 When the inner cap 56 is inserted into the outer cap 58, the annular rib 80 on the inside of the outer cap 58 engages the undercut 70 on the outside of the inner cap 56, thus retaining the inner cap 56.
  • inner cap 56 In the area of proximal end 60, inner cap 56 has a cavity 66 communicating with a vent 69 on the outer periphery of inner cap 56. In this cavity 66 projects in the proximal direction, a conical or frusto-conical plug 64 ( Figure 2) on the outer circumference of the inner cap 56 ribs 68 are provided to prevent rotation of the inner cap 56 in the outer cap 58.
  • an internal thread 52 is provided at the distal end 48 of the cuff 44, which has a corresponding external thread 82 arranged on the outer surface of the outer cap 58 in the proximal region interacts.
  • the distal end of the tip 22 engages in the cavity 66 of the inner cap 56 until the frontal distal end of the tip 22 abuts the bottom of the cavity 66.
  • the plug 64 engages the passage 24 of the tip 22 and seals this passage 24 from.
  • the cuff 44 tends to disengage from the tip 22 during rotational applications. It has been found that in particular when screwing female, conical counterparts into the sleeve 44 leaks between the tip 22 and the conical counterparts used can occur, which can lead to the complete loss of the connection.
  • the sleeve 44 is erfmdungswash and as shown schematically in Figure 3 via a shrink tube 9 to the container wall 18 of the syringe container 12, wherein the shrink tube 9, the sleeve 44 at least in a proximal region 7 and the container wall 18 in a distal Area 8 engages on the outside.
  • FIG. 3 shows the shrinking tube 9 shrunk over the proximal region 7 of the sleeve 44 and the distal region 8 of the container wall 18.
  • the shrinking tube 9 is in a not yet shrunk state around the proximal region 7 of the sleeve 44 and the distal region 8
  • Container wall 18 is placed to indicate the position of the shrink tube 9, in which it is shrunk over the sleeve 44 and the distal portion 8 of the container wall 18.
  • the shrinking tube 9 lying around in the position of FIG. 4 is shrunk and lies against the proximal region 7 of the sleeve 44 and the distal region 8 of the container wall 18 positively.
  • the sleeve 44 is held at the top 22 of the syringe container 12 by positive engagement and in particular fixed against rotation relative to the syringe container 12.
  • the sleeve 44 can no longer detach from the syringe container 12. A twisting of the sleeve 44 with respect to the syringe container 12 is excluded. As a result, not only a secure seal of the passage 24 is ensured by the tip cap assembly 54 but also a tight fit any counterparts.
  • the heat shrink tubing 9 is preferably a heat shrink tubing made of a polyolefin such as polyethylene. It may alternatively be a polyvinylidene fluoride (PVDF) heat shrink tubing.
  • the shrink tube has a shrinkage ratio of 2: 1 to 3: 1.
  • the heat shrink tubing is made of a transparent material so that contents in the (also preferably transparent) syringe container 12 remain visible.
  • the shrink tube 9 can also be colored, so as to make a mark at the same time.
  • the proximal region 7 of the sleeve 44 encompassed by the shrink tubing 9 extends at least over half the height H of the sleeve 44.
  • the proximal region 7 covered by the shrink tubing 9 extends Cuff 44 over a height of at least 4 mm.
  • the distal region 8 of the container wall 18 encompassed by the shrink sleeve 9 extends at least as far as the cylindrical outer region of the syringe container, and preferably over more than 10 mm and particularly preferably over more than 12 mm.
  • the total height H of the shrink tubing 9 is expediently between 20 mm and 30 mm in the case of a 10 ml syringe in the form of a HYP AK® syringe from Becton Dickinson, and is preferably approximately 25 mm. From the outset, it is easy for a person skilled in the art to adapt the shrink tubing dimensions to syringes with different nominal contents or differing outside diameters.
  • the attachment of the sleeve 44 at the top 22 of the syringe container 12 is also with the use of the syringe container 12 with any conical counterparts such.
  • the cannula is also screwed to the internal thread 52 of the sleeve 44 via a flange 42 (FIG. 1) provided at the proximal end of the cannula.
  • the shrink tube 9 prevents twisting or loosening of the sleeve 44th relative to the container wall 18 of the syringe container 12 and thereby releasing the connection between the cannula 30 and the tip 22 of the syringe container 12.
  • the shrink tube 9 a ensure safe connection of the respective connector part to the connection arrangement of the syringe container according to the invention.
  • the syringe container 12 according to the invention for syringes which are prefilled with a substance and which must be sterilized before use.
  • the shrinking of the shrink tube 9 can in this case take place during the sterilization process, wherein the material of the shrink tube is adapted to the sterilization temperatures. If the shrink tube shrunk at the usual sterilization temperatures (for example, 121 0 C in a steam sterilization), then this is in particular heat shrink tubing made of polyethylene.

Abstract

L'invention concerne un réservoir (12) pour une seringue (10) muni d'une paroi de réservoir (18) entourant une chambre (20) pour le logement d'une substance et d'une pointe (22) dépassant d'une extrémité distale (16) de la paroi de réservoir (18), laquelle pointe présente un passage (24) en communication avec la chambre (20). Un agencement de liaison est disposé sur la pointe (22) pour relier le réservoir de seringue (12) avec un élément de raccordement (58, 42) correspondant et présente un manchon (44) entourant la pointe (22) de façon concentrique. Afin de garantir que la pièce complémentaire montée sur le réservoir de seringue, qui présente un élément de raccordement correspondant à l'agencement de liaison sur le réservoir de seringue, soit logée de façon fixe et étanche et ne puisse pas être détachée de façon incontrôlée ni lors du montage ni lors de l'utilisation et que le manchon ne se détache pas lors du montage même sous l'effet de mouvements de rotation, il est prévu selon l'invention que le manchon (44) soit fixé au moyen d'une gaine thermorétractable (9) sur la paroi de réservoir (18), ladite gaine (9) entourant le manchon (44) au moins dans une zone proximale (7) et la paroi de réservoir (18) dans une zone distale (8), respectivement sur le côté extérieur.
PCT/EP2010/062451 2009-08-27 2010-08-26 Réservoir pour une seringue WO2011023748A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202009011640U DE202009011640U1 (de) 2009-08-27 2009-08-27 Spritzenbehälter für eine Spritze
DE202009011640.9 2009-08-27

Publications (1)

Publication Number Publication Date
WO2011023748A1 true WO2011023748A1 (fr) 2011-03-03

Family

ID=42988346

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/062451 WO2011023748A1 (fr) 2009-08-27 2010-08-26 Réservoir pour une seringue

Country Status (2)

Country Link
DE (1) DE202009011640U1 (fr)
WO (1) WO2011023748A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4119173A1 (fr) * 2021-07-14 2023-01-18 Marco Spichiger Coiffe de fermeture et système de fermeture pour une seringue préremplie d'un médicament ou d'un principe actif médical

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1727755A (en) * 1925-01-15 1929-09-10 Fairleigh S Dickinson Method of permanently securing metal to glass
US6027482A (en) 1994-12-12 2000-02-22 Becton Dickinson And Company Syringe tip cap
DE19956243A1 (de) 1998-11-24 2000-05-25 Becton Dickinson Co Spritze und Spitzenkappe hierfür
US20030187403A1 (en) * 2002-03-30 2003-10-02 Ernest Balestracci Tamper evident overap for a container
WO2010064074A1 (fr) * 2008-12-02 2010-06-10 Becton Dickinson France Récipient de médicament amélioré

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE8408869U1 (de) * 1984-03-22 1984-07-12 Miltex GmbH, 7200 Tuttlingen Hochdruckinjektionsspritze
US6022344A (en) * 1997-12-04 2000-02-08 Npbi International B.V. Cryopreservation bag
DE20315872U1 (de) * 2003-10-15 2004-02-12 B. Braun Melsungen Ag Schutzvorrichtung für eine Injektionsnadel

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1727755A (en) * 1925-01-15 1929-09-10 Fairleigh S Dickinson Method of permanently securing metal to glass
US6027482A (en) 1994-12-12 2000-02-22 Becton Dickinson And Company Syringe tip cap
DE19956243A1 (de) 1998-11-24 2000-05-25 Becton Dickinson Co Spritze und Spitzenkappe hierfür
US20030187403A1 (en) * 2002-03-30 2003-10-02 Ernest Balestracci Tamper evident overap for a container
WO2010064074A1 (fr) * 2008-12-02 2010-06-10 Becton Dickinson France Récipient de médicament amélioré

Also Published As

Publication number Publication date
DE202009011640U1 (de) 2011-01-13

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