WO2008077484A1 - Chapeau pour une seringue et/ou une carpule, et son procédé de fabrication - Google Patents

Chapeau pour une seringue et/ou une carpule, et son procédé de fabrication Download PDF

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Publication number
WO2008077484A1
WO2008077484A1 PCT/EP2007/010845 EP2007010845W WO2008077484A1 WO 2008077484 A1 WO2008077484 A1 WO 2008077484A1 EP 2007010845 W EP2007010845 W EP 2007010845W WO 2008077484 A1 WO2008077484 A1 WO 2008077484A1
Authority
WO
WIPO (PCT)
Prior art keywords
attachment
sealing element
syringe
core
holding element
Prior art date
Application number
PCT/EP2007/010845
Other languages
German (de)
English (en)
Other versions
WO2008077484A8 (fr
Inventor
Petra Hund
Joachim Glocker
Original Assignee
Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg
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 Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg filed Critical Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg
Publication of WO2008077484A1 publication Critical patent/WO2008077484A1/fr
Publication of WO2008077484A8 publication Critical patent/WO2008077484A8/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
    • 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
    • A61M5/50—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

Definitions

  • the invention relates to an attachment for a syringe or a carpule according to the preamble of claim 1, in addition a method for producing such an attachment according to the preamble of claim 12, finally a method for producing such an attachment according to the preamble of claim 22.
  • Attachments for a syringe and / or a cartridge and a method for their preparation are known. They serve to seal the syringe or carpule until it is put to use. It has been found that in some cases the access to the interior of the syringe or carpule in the long run can not be optimally sealed, in particular does not remain gas-tight.
  • the object of the invention is therefore to provide an essay which does not have this disadvantage.
  • an essay which comprises the features mentioned in claim 1. It has a base body and at least one sealing element which can be introduced into the base body and which is arranged in the region of an opening of the syringe or carpule.
  • the article is characterized in that it comprises at least one sealing element Teflon and / or PTFE (poly-tetra-fluoro-ethylene) and characterized in that the sealing element is elastically mounted in the attachment, so applied in the mounted state of the attachment with a resilient force and pressed against the opening.
  • Particularly preferred is an embodiment which is characterized in that the sealing element is coated with Teflon and / or PTFE. It is therefore possible to equip the sealing element with a core whose strength and elasticity properties are optimally adaptable to the required sealing properties, and which can be coated with Teflon and / or PTFE.
  • the sealing element made of Teflon or PTFE.
  • a sealing element which consists only of a material, is particularly inexpensive to produce.
  • the object of the invention is also to provide a method by which an attachment can be produced, which does not have the disadvantage mentioned.
  • an attachment is provided, at least one sealing element comprising Teflon and / or TPFE is introduced into the attachment and fastened by means of an injection molding process.
  • the attachment at least the base body, is produced by injection molding.
  • TPE is used for the holding element.
  • a two-component injection molding process is used in the production of the attachment and of the retaining element. It is possible to produce the attachment and the retaining element in a single process step.
  • the sealing element introduced into the attachment is positioned and held on a first core introduced through an opening of the attachment.
  • it is preferably held by means of a negative pressure on the first core, in particular sucked by a vacuum.
  • the sealing element introduced into the attachment is fixed to the first core by a second core, which is introduced into the attachment from the side opposite the opening.
  • a method is preferred in which the second core forms the inner contour of the injected material.
  • a method for producing an article is proposed to solve this problem, having the features mentioned in claim 22.
  • a sealing element is introduced between two cores, which are preferably arranged in alignment with each other. The sealing element is arranged in an injection mold, then the sealing element held by the cores is encapsulated with plastic.
  • the inner contour of the injection mold is formed so that an attachment is molded during encapsulation of the sealing element with plastic.
  • the inner contour of the injection mold is designed so that a Haiteelement is formed during encapsulation of the sealing element with plastic.
  • a method is preferred which is characterized in that in a two-component injection molding process, the sealing element is encapsulated with a holding element and an attachment in one process step.
  • FIG. 1 shows a longitudinal section through an embodiment of a
  • FIG. 1 shows an attachment 1, which is placed on a syringe 3, which comprises an inner space 5.
  • the article 1 has a base body 7, in which a sealing element 9 is inserted, which is arranged in the region of an opening 11 of the syringe 3.
  • the syringe 3 has a projection 13 with a passage 15, the opening 11 of which is closed by the sealing element 9.
  • the sealing element 9 is preferably fixed elastically in the base body 7 of the attachment 1.
  • a holding element 19 made of an elastic material is inserted into an interior 17 of the main body 7, which holds the sealing element 9.
  • the holding element 19 - as in the embodiment illustrated here - can also be preferably designed as a sealing cap which surrounds the neck 13 from the outside and fills the interior 17.
  • the sealing element 9 is preferably formed as a disc, in particular as a round disc. But is also preferred an embodiment of the sealing element 9, which is cap-shaped and the opening of the syringe 3 or carpule, here the projection 13 overlaps.
  • the article 1 is preferably made of hard plastic, for example PP (poly-propylene) or PE (polyethylene).
  • the sealing element 9 comprises Teflon and / or PTFE (polytetrafluoroethylene). It can be provided that the sealing element 9 has a core which is adapted to the forces occurring during sealing of the syringe 3 or carpule forces. It can be used here hard plastic, metal or glass. Preferably, however, the sealing element 9 is made entirely of Teflon or PTFE. In particular when producing the sealing element 9 made of Teflon, the following advantage results: This material is distinguished by the fact that it is particularly gas-tight and chemically inert.
  • a sealing element 9 made of Teflon is pressed against an opening of a syringe 3 or carpule, it securely closes off the opening.
  • Teflon but also with the use of PTFE ensures that an interaction of the sealing element 9 with the contents of the syringe 3 or carpule practically completely eliminated and a high storage stability is ensured.
  • the holding element 19 is preferably made of a softer material than the sealing element 9, in particular TPE (thermoplastic elastomer) is used. Particular preference is given to using materials for the main body 7 of the attachment 1 and for the retaining element 19, which can be produced by means of an injection molding process. Particularly preferred are plastic materials, with which the attachment 1, in particular its base body, and the holding element 19 can be produced in a two-component injection molding process.
  • the holding element 19 is preferably characterized in that it comprises elastic material, in particular consists of an elastic material and thus the sealing element 9 is acted upon by a yielding force and pressed against the opening of the syringe 3 or carpule. As a result, the sealing element 9 reliably seals the syringe 3 or the carpule for a long time.
  • the attachment 1 comprises at its end facing the syringe 3 a retaining ring 21 which engages around a fastening ring 23 placed directly on the syringe 3 and which is otherwise connected to the base body 7 of the attachment 1 via a predetermined breaking line 25.
  • a predetermined breaking line 25 typically, this allows the attachment 1 to be removed from a syringe 3 or carpule by bursting the predetermined breaking line 25 by turning, tilting or pulling forces and the attachment 1 is removed, while the retaining ring 21 and the attachment ring 23 remain on the syringe 3 or carpule.
  • a softer, more grippy material can be provided on the outer side of the attachment 1, at least in some areas, in order to provide gripping regions 27, so that the attachment 1 is well grasped even with protective gloves and slightly detached from the syringe 3 Carpule can be removed.
  • the holding member 19 and the handle portions 27 are made of one and the same material, the injection-molded on the main body 7 of the attachment 1 is molded in a single process step. It is also possible in this case to produce the gripping regions 27 simultaneously with the holding element 19 and the base body 7 in a two-component injection molding process.
  • Figure 1 shows that the sealing element 9 is pressed sealingly against the opening 11 in the mounted state of the attachment 1. It is in principle possible that the sealing element 9 is held directly by the base body 7 of the attachment 1. Preferably, however, it is provided that the sealing element 9 is attached elastically to the base body 7. It is conceivable, for example, to provide the inner wall of the inner space 17 with a groove and to allow the sealing element 9 to snap in there. Particularly preferred is an embodiment of the article 1, in which in such a groove an elastic material is introduced, in particular injected, which then forms the retaining element 19 for the sealing element 9 and this holds yielding.
  • the interior 17 of the cap 1 is provided with a substantially over the height of the inner space 17 extending holding member 19, in particular injected, on the one hand the sealing element 9 elastically holds, on the other hand preferably - In the attached state of the essay 1 - additionally comprises the neck 13 from the outside elastically and seals.
  • the sealing element 9 on its side facing away from the opening 11 of a sufficient amount of material of the holding member 19 is included, so that it is resiliently pressed against the opening 11 of the main body 7 of the attachment 1.
  • a structure 29 may be provided on its outer side, preferably circumferential grooves and ribs in the base body 7 of the attachment 1, here in the holding element 19 engage and contribute to the secure anchoring of the sealing element 9.
  • the sealing element 9 can preferably also be provided with an outer contour in order to be securely anchored in the attachment 1 or in the retaining element 19.
  • the outer edge of the sealing element 9 can be jagged or star-shaped.
  • the article 1 is provided in the region of its top 31 with an opening 33 which extends to the sealing element 9, so also penetrates the holding member 19 above the sealing element 9. As a result, the sealing element 9 is accessible from above.
  • the opening 33 serves to be able to hold the sealing element 9 in the manufacture of the article 1 at a desired position.
  • FIG. 2 shows a reduced, the embodiment shown in Figure 1 of the article 1.
  • the same parts are provided with the same reference numerals, so reference is made in this regard to the description of Figure 1.
  • the main body 7 of the attachment 1 is essentially cylindrical, the external diameter of the attachment 1 being substantially cylindrical.
  • the predetermined breaking line 25 between the main body 7 and the retaining ring 21 is clearly visible.
  • the outside diameter of the main body 7 can approximately correspond to that of the syringe 3 or carpule.
  • the attachment 1 is provided at its end remote from the syringe 3 with an enlarged outwardly projecting region 35, so that the attachment 1 can be more easily grasped and removed from the syringe 3 or rotated.
  • flattening preferably concave flattening, can be provided, which are provided with a non-slip material for forming the at least one gripping region 27.
  • concave gripping regions 27 are formed on two opposite sides. The number and design of these areas can be adapted to the different applications. Also, grippy material can be provided on a cylindrically shaped portion 35 without providing recessed grips.
  • an essay 1 is provided.
  • a sealing element 9 is introduced and secured at a suitable location. It is conceivable to anchor the sealing element 9 to the inner wall of the inner space 17, for example clipping it into a groove present there. This is possible in particular if the Attachment 1 itself consists of an elastic material, so that with attached attachment 1 on a syringe 3 or carpule, the sealing element 9 is resiliently pressed against an opening of the syringe / carpule.
  • the sealing element 9 is anchored in the interior 17 of the attachment 1 by means of an injection molding process in which an elastic retaining element 19 is realized.
  • a sealing element 9 it is therefore possible to attach the sealing element 9 to a base body 7 of an attachment 1 in any desired manner, for example clipping into a groove.
  • a holding element 19 is provided, which consists of elastic material.
  • the article 1 of an elastic material, in particular by means of an injection molding process, and thereby to overmold the sealing element 9 at least in its edge region so that it is securely held inside the article 1. It is also conceivable to provide a groove on the inner wall of the interior 7, to insert the sealing element 9 there and to overmold it with an elastic material in such a way that it is elastically held within the groove.
  • the article 1 can also be made of a rather inelastic material.
  • the sealing element 9 is held in the region of the groove by means of a first core inserted through the opening 33 and a second core inserted into the attachment 1 from the opposite side and then encapsulated with an elastic material which encapsulates the Holding element 19 forms.
  • the sealing element 9 which is preferably designed as a disk, can be held by two cores, one of which is introduced through the opening 33 into the interior 17 of the base 7 of the attachment 1.
  • the cores are arranged substantially in alignment with each other, so that their central axes practically coincide.
  • the sealing element 9 is held by a first core, which is inserted through the opening 33 in the attachment 1.
  • This first core preferably has a suction bore, through which the sealing element 9 can be sucked by a vacuum.
  • a second core is preferably provided, which is inserted through the opening 33 of the opposite side of the attachment 1 and the sealing element 9 presses against the first core so as to fix it in a specific position.
  • the second core may have a certain outer contour, so that the material injected into the attachment 1 adapts to this outer contour and forms the inner contour of the injected material, for example the retaining element 19. If a holding element 19 is injected into the attachment, the second core preferably has the shape of the subsequently introduced attachment 13 of a syringe or carpule.
  • the sealing element 9 can be held at a desired position and then encapsulated with the holding element 19, so that the attachment 1 shown in FIG. 1 is created.
  • the holding element 19 can be formed as a sealing element which encloses an attachment 13 of the syringe 3 or carpule.
  • the guided through the opening 33 core on the one hand holds the sealing element 9, which then on the other hand supported on a second core, is formed so that it closes the opening 33 tight, so that the material of the holding member 19 during injection in the interior 17 of the body 7 through the top 31 can not escape.
  • the gripping regions 27 can be injection-molded onto the base body 7 of the attachment 1 at the same time as the holding element 19.
  • the article 1 can also be produced in a single process step.
  • the sealing element 9 is clamped and held between two cores.
  • the main body 7 of the attachment 1 and the holding element 19 are produced in a two-component injection molding process, whereby the grip regions 27 can also be realized at the same time.
  • the holding element 19, as in the exemplary embodiment according to FIG. 1, is cap-shaped in order to encompass a projection 13 of a syringe 3 or carpule, then the cavity enclosed by the holding element 19 is formed in the manufacturing process by a shaped body which passes through the mold second core is realized and which holds the sealing element 9 on one side, while on the other side a core is provided, which then passes through the opening 33 of the base body 7.
  • the sealing element 9 is encapsulated, wherein in a two-component injection molding process, the holding element 19 and the attachment 1 are produced in a common process step. It is also possible first to produce the holding element 19 in an injection molding process and then to overmold this with plastic to produce the attachment 1. It is also possible, as explained above, to produce the attachment 1 in a first step, to introduce the sealing element 9 into it and to hold it by means of a core guided through the opening 33 and through a core, which may also be formed as a molding, and then to inject the holding member 19 in the article 1.
  • the second core which is used as a molded body, and the first core, which passes through the opening 33, are removed.
  • the opening 33 can ultimately be dispensed with if the sealing element 9 is held by a shaped body, for example by means of negative pressure, while the retaining element 19 is injected around the sealing element 9.
  • the attachment 1, at least its base body 7, can also be produced.

Abstract

L'invention concerne un chapeau (1) pour une seringue (3) ou une carpule, avec un corps de base (7) et avec au moins un élément d'étanchéité (9) pouvant être introduit dans le corps de base (7) et disposé dans la région d'une ouverture (11) de la seringue (3) ou de la carpule. Ce chapeau est caractérisé par le fait que l'élément d'étanchéité au moins unique (9) comprend du Téflon et/ou du PTFE et est fixé élastiquement dans le chapeau (1).
PCT/EP2007/010845 2006-12-21 2007-12-12 Chapeau pour une seringue et/ou une carpule, et son procédé de fabrication WO2008077484A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102006060605.1 2006-12-21
DE102006060605 2006-12-21
DE102007003523 2007-01-19
DE102007003523.5 2007-01-19

Publications (2)

Publication Number Publication Date
WO2008077484A1 true WO2008077484A1 (fr) 2008-07-03
WO2008077484A8 WO2008077484A8 (fr) 2008-08-21

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2007/010845 WO2008077484A1 (fr) 2006-12-21 2007-12-12 Chapeau pour une seringue et/ou une carpule, et son procédé de fabrication

Country Status (1)

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WO (1) WO2008077484A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4412836A (en) * 1979-04-27 1983-11-01 The West Company, Incorporated Syringe assembly
EP0917882A1 (fr) * 1997-11-19 1999-05-26 Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg Seringue en particulier une seringue ou ampoule préremplie
EP1099450A1 (fr) * 1999-11-11 2001-05-16 Helvoet Pharma Belgium N.V. Capuchon de protection pour une canule
EP1101505A1 (fr) * 1999-11-19 2001-05-23 Schott Glas Capuchon pour une seringue pré-rempliable, à usage unique
US20030078546A1 (en) * 2001-10-22 2003-04-24 Jensen James U. Injection needle assembly
EP1466638A2 (fr) * 2003-04-09 2004-10-13 Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg Seringue préremplie ou carpule à usage médical
EP1502616A1 (fr) * 2003-08-01 2005-02-02 Bünder Glas GmbH Protecteur d'aiguille pour des seringues en verre

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4412836A (en) * 1979-04-27 1983-11-01 The West Company, Incorporated Syringe assembly
EP0917882A1 (fr) * 1997-11-19 1999-05-26 Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg Seringue en particulier une seringue ou ampoule préremplie
EP1099450A1 (fr) * 1999-11-11 2001-05-16 Helvoet Pharma Belgium N.V. Capuchon de protection pour une canule
EP1101505A1 (fr) * 1999-11-19 2001-05-23 Schott Glas Capuchon pour une seringue pré-rempliable, à usage unique
US20030078546A1 (en) * 2001-10-22 2003-04-24 Jensen James U. Injection needle assembly
EP1466638A2 (fr) * 2003-04-09 2004-10-13 Arzneimittel GmbH Apotheker Vetter & Co. Ravensburg Seringue préremplie ou carpule à usage médical
EP1502616A1 (fr) * 2003-08-01 2005-02-02 Bünder Glas GmbH Protecteur d'aiguille pour des seringues en verre

Also Published As

Publication number Publication date
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