EP0737467A1 - Dispositif de réunir une première composante liquide et une deuxième composante rigide ou liquide au moyen de vide sous des conditions stériles - Google Patents

Dispositif de réunir une première composante liquide et une deuxième composante rigide ou liquide au moyen de vide sous des conditions stériles Download PDF

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Publication number
EP0737467A1
EP0737467A1 EP19960103858 EP96103858A EP0737467A1 EP 0737467 A1 EP0737467 A1 EP 0737467A1 EP 19960103858 EP19960103858 EP 19960103858 EP 96103858 A EP96103858 A EP 96103858A EP 0737467 A1 EP0737467 A1 EP 0737467A1
Authority
EP
European Patent Office
Prior art keywords
hollow body
cannula
container
guide
wall
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP19960103858
Other languages
German (de)
English (en)
Other versions
EP0737467B1 (fr
Inventor
Thomas Dr. Pfeifer
Dietmar Weitzel
Wolfgang Kneip
Bernhard Dr. Vohwinkel
Axel Von Brand
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CLS BEHRING GmbH
Axel Von Brand GmbH
Original Assignee
Behringwerke AG
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 Behringwerke AG filed Critical Behringwerke AG
Publication of EP0737467A1 publication Critical patent/EP0737467A1/fr
Application granted granted Critical
Publication of EP0737467B1 publication Critical patent/EP0737467B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means

Definitions

  • the invention relates to a device for bringing together a first liquid and a second solid or liquid component by means of negative pressure under sterile conditions, with a first container holding the first component and a second container holding the second component under pressure, and a cylindrical hollow body for holding the first container in the area of its closure in a first hollow body opening and a second hollow body opening arranged diametrically to this, for receiving the second container in the region of its closure, and at least one cannula mounted in the hollow body and displaceable in its longitudinal direction for piercing the respectively closing the containers Sealing plug, the cannula being mounted in a cannula holder.
  • Such a device which forms part of a preassembled system for transferring liquids, is known from DE 38 17 101 A1.
  • the system allows the second container with the attached device to be placed on the market, so that in order to transfer liquid into this second container, only the first container has to be attached to the unit formed by the second container and the device.
  • the displaceable mounting of the cannula in the hollow body and a drive-over resistance protruding into the path of the cannula holder ensure that the second container inserted into the hollow body is connected to it but does not come into contact with the cannula.
  • a circumferential projection is provided both on the cannula support and on a bearing sleeve forming part of the hollow body.
  • the resistance resulting from the contact between the two projections for driving over the projection on the bearing sleeve side is greater than the penetration resistance of the cannula when penetrating into the sealing plug of the first container.
  • the disadvantage here is that the formation of the parts with the projections requires an exact dimensioning of the outer projection diameter of the cannula holder and the inner projection diameter of the bearing sleeve in order to achieve the chronological puncturing of the sealing plugs of the containers.
  • the projections also require an increased manufacturing outlay for the device, based on the manufacture of the cannula holder and the hollow body, and the rest of the assembly of the device in the area of the cannula holder is quite complex.
  • the cannula carrier is designed as a plate-shaped body oriented perpendicular to the longitudinal direction of the hollow body, which is connected to the inner wall of the hollow body by means of retaining webs, the retaining webs being able to be torn by applying a manual force , which is greater than the penetration force of the cannula when piercing the sealing plug of the first container.
  • the cannula holder is thus fixed to the inner wall of the hollow body by means of the plate-shaped retaining webs before the cannula is inserted into the sealing plug of the second container.
  • a displacement of the cannula is therefore only possible if the holding bars were previously torn by applying the manual force. This ensures a safe sequential sequence of the movement.
  • the design of the device enables its simple design by, as the case may be, down to the cannula Plastic injection molded part is designed.
  • the cannula carrier is connected to guide projections which are directed towards the inner wall of the hollow body. After the holding webs have been separated, these enable the cannula holder to be guided largely without tilting relative to the inner wall of the hollow body, and thus a largely exact guidance of the cannula in the piercing area to the second container, the cannula also being held in the sealing plug of the first container.
  • the hollow body advantageously has an opening with a circular cross section.
  • a triangular or circular configuration of the cannula holder is appropriate.
  • the cannula holder has, for example, the shape of an equilateral triangle, with three guide lugs which are connected to the cannula holder in the area of the center of the triangular sides of the cannula holder.
  • four guide lugs are preferably connected to the circumference of the cannula carrier.
  • the guide lugs can have radially outer concentric to the cannula and guide lugs extending in the longitudinal direction of the hollow body.
  • a preferred development of the invention provides that guide projections extending in the longitudinal direction thereof are connected to the inner wall of the hollow body, between which the guide projections or the corners of the cannula holder are arranged.
  • the respective guide approach should be connected to the cannula support via a central web and two guide approaches should engage behind the guide approach in the area of the central web.
  • the design of the hollow body with guide lugs necessitates a defined positioning of the cannula carrier relative to the hollow body during its displacement in the longitudinal direction and also prevents relative rotation or tilting of the cannula carrier relative to the hollow body.
  • the container in the hollow body it is advantageously extended in the area of at least one end parallel to the container to be received by the associated hollow body opening.
  • the extension causes the container not only in the area of the plug having the container neck is held, but the extended portion of the hollow body also at least partially surrounds the generally enlarged, voluminous area of the container at a greater or lesser distance, so that tilting of the container in the hollow body is excluded.
  • This is particularly important for the container that holds the substance under negative pressure or vacuum conditions, so that when the liquid is transferred into this container, it does not have to be actively carried out, but is only required for the other container that holds the liquid.
  • the elongated section of the hollow body expediently has an inner diameter which is slightly larger than the outer diameter of the container. This not only prevents the container from accidentally tipping over, but also guides the container in a defined manner.
  • the device with the two containers forms a preassembled, sterile packaged system, in which the two containers are kept out of contact with the cannula in the cylindrical hollow body and a packaging includes the containers and the hollow body in a sterile manner.
  • a transfer system and packaging are available that significantly simplify, accelerate the preparation of the components in the containers, and allow preparation that is completely separate from the immediate use, as well as allow the reconstituted components to be stored for several days.
  • the design and arrangement of the transfer system enables a quick, safe, confusion-free and irreversible transfer of the component located in the first container to the second container containing the other component with the least possible effort for the user and while maintaining sterility even after the components have been merged.
  • Figure 1 shows a cylindrical hollow body 3, the two hollow body openings 6 and 7 have the same inner diameter.
  • the upper hollow body opening 6, based on the orientation of FIG. 1, serves to hold a bottle 1 which holds a liquid
  • the lower opening 7 serves to hold a bottle 2 which holds a substance under vacuum or vacuum conditions.
  • the opening of the respective bottle 1 or 2 closes Rubber stopper, not shown, which is held by means of a crimp cap 4 or 5.
  • the bottle 1 or 2 is inserted into the hollow body 3 and held by the latter.
  • a plate-shaped cannula carrier 9 is arranged within the hollow body 3, which is positioned perpendicular to the central longitudinal axis 31 of the hollow body 3.
  • the cannula support 9 is fixedly connected to the inner wall 30 of the hollow body 3 via a plurality of radially extending holding webs 13.
  • the cannula holder 9 has a through hole for receiving a cannula 8, the through axis of which coincides with the central longitudinal axis 31.
  • the bottle 2 After insertion into the hollow body 3, the bottle 2 contacts stops 10 connected to the inner wall 30 of the hollow body 3, so that it cannot be pushed further into the hollow body 3 in the direction of the cannula 8, but rather is clamped between the assigned inner wall section of the hollow body 3 .
  • the liquid-absorbing bottle 1, on the other hand, is held in a preassembled position in a section of the hollow body 3 facing the actual hollow body opening area, an inner annular bead 33 oriented parallel to the cannula holder 9 projecting into the displacement path of the crimp cap 4 and thus defining the installation position. In the preassembled position shown in FIG.
  • the transfer system is already sealed and sterilized in a peelable outer packaging 14 by the pharmaceutical manufacturer, as illustrated in FIG. 2.
  • This outer packaging 14 consists of a thermoformed soft blister film, preferably PA / PE and a sterilizable, sealable medical paper or a polyethylene spunbond. After the labeled and assembled units have been sealed in, they are sterilized, for example with ethylene oxide. In an appropriately designed Secondary packaging, the user then prepares the components in the sterile outer packaging, while maintaining sterility despite piercing the respective containers.
  • Figures 3a to 3c illustrate the processes to bring the components together.
  • Figure 3a illustrates the pre-assembled system as shown in Figure 1. Proceeding from this, the liquid-absorbing bottle 1 is pushed further into the hollow body 3, the cannula 8 penetrating the sealing plug of the bottle 1, which is made of rubber. This is possible because the penetration or penetration force of the cannula 8 into or through the rubber stopper of the bottle 1 is less than the force required to pull the cannula holder 9 connected to the hollow body 3 via the holding webs 13 from the latter separate. In the advanced position of the bottle 1 shown in FIG.
  • the crimp cap 4 of this bottle 1 comes into contact with the cannula holder 9, so that the push-in force manually exerted on the bottle 1 for pushing in the bottle 1 is transferred directly to the cannula support 9 in the hollow body 3.
  • the retaining webs 13 tear, so that the bottle 1 together with the cannula holder 9 and thus the cannula 8 is displaced further in the direction of the bottle 2 within the hollow body 3, so that the cannula 8 pierces the rubber stopper of this bottle 2 .
  • the negative pressure in the bottle 2 sucks the liquid from the bottle 1 into the bottle 2 and leads to the dissolution or mixing of the solid or liquid component contained therein.
  • the system with the cannula 8 in the transfer position is shown in FIG. 3c.
  • FIGS. 4a and 4b illustrate the device for merging the components described in FIGS. 1 to 3c for the transfer system in detail.
  • the hollow body 3 is formed in the region of the hollow body opening 6 as a ring 34 with retaining webs 16 connected to one another only by thin points.
  • bottles 1 of different volumes for example all injection bottles from 6 to 100 ml, since when activating bottle 1 with a nominal volume greater than or equal to 10 ml, insertion into hollow body 3 is only possible if it is initially used for fixation used ring is blown up and offers the larger body diameter of the bottle 1 place.
  • the cannula carrier 9 essentially has the shape of a circle and is provided with four guide lugs 35 which are connected to the cannula carrier 9 at 90 ° relative to one another on the circumference thereof.
  • the guide lugs 35 have a guide surface 36 which extends concentrically to the cannula 8 and extends in the longitudinal direction of the hollow body 3 radially on the outside. This is arranged at a short distance from the inner wall 30 of the hollow body 3, so that the cannula support 9 after the tearing of the holding webs 13 is free of play and thus can be moved in the hollow body 3 so that it cannot tip over.
  • the hollow body 3 is provided on the inside with four ribs 37, which run in the longitudinal direction of the hollow body 3 and are each offset by 90 ° to one another, which define the receiving diameter of the hollow body 3 for the bottle 1 and thus ensure an exact positioning of the bottle 1, whereby the insertion of this bottle 1 because of its abutment with its crimp cap 4 on the ribs 37 can be carried out with little effort.
  • the ribs 37 penetrate recesses 38 between the guide lugs 35.
  • Reference numeral 15 denotes a holding web arranged in the plane of the stops 10 and connected to the interior of the hollow body 3, which, after the components have been reconstituted when the bottle 2 is pulled out of the hollow body 3, prevents the cannula carrier 9 from falling out of the hollow body 3 or the cannula 8 held in the cannula holder 9 gets stuck in the rubber stopper of the bottle 2.
  • the cannula carrier 9 has essentially the shape of an equilateral triangle and three guide lugs 35 are provided which are connected to the cannula carrier 9 in the area of the center of the triangular sides of the cannula carrier 9.
  • wing-like guide lugs 12 extending in the longitudinal direction thereof are connected, between which the guide lugs 35 of the cannula holder 9 are arranged.
  • the respective guide projection 35 is connected to the cannula support 9 via a central web 39 and two adjacent guide projections 12 engage behind the guide projection 35 in the region of the central web 39.
  • Each guide projection 35 is connected to the hollow body 3 via a holding web 13.
  • the triangular dimension of the cannula carrier 9 is selected so that its tips are positioned with minimal play relative to the inner wall 30 of the hollow body 3, which otherwise also applies to the position of the guide surface 36 of the respective guide projection 35 and the inner wall 30 of the hollow body 3.
  • Adjacent guide lugs 12 are arranged so as to diverge from the inner wall 30 that they accommodate a corner 40 of the cannula holder 9 between them.
  • the crimp cap 4 of the bottle 1 is preassembled on the guide lugs 12 up to the recessed lugs 11 of the guide lugs 12.
  • the guide lugs 12 become radially outward bent, the crimp cap 4 comes into contact with the cannula holder 9 and the retaining webs 13 are blown up when an increased manual force is applied.
  • the hollow body opening 7 has a greater longitudinal extent (compared to the embodiment according to FIG. 6a). This is achieved by an extension of the ring section 45 of the hollow body 3 forming the opening.
  • the inside diameter of the ring section is dimensioned slightly larger than the outside diameter of the bottle 2 in the bottle section 46.
  • Figure 7 illustrates that the outer diameter of the crimp cap 5 is smaller than the outer diameter of the container 2 and the ring portion 45 extends to the side of the flange portion 46. This effectively prevents the bottle 2 from tilting in the hollow body opening 7.
  • the upper hollow body opening 6 is designed accordingly, that is to say that the bottle 1 is also guided there in the area of its bottle section 46, and thus its maximum expanded area.
  • the transfer device according to FIGS. 4a and 4b is suitable for injection bottles 1 and 2 with a nominal size of 20 mm.
  • the transfer device according to FIGS. 5a and 5b serves to transfer a substance from a bottle 1 with a nominal size of 13 mm into a bottle 2 with a nominal size of 20 mm.
  • the device serves to hold bottles 1 and 2 with a nominal size of 13 mm.
  • the embodiment according to FIGS. 7a and 7b also serves to hold bottles 1 and 2 with a nominal size of 13 mm.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Loading And Unloading Of Fuel Tanks Or Ships (AREA)
  • Package Specialized In Special Use (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • External Artificial Organs (AREA)
  • Closing Of Containers (AREA)
EP19960103858 1995-04-11 1996-03-12 Dispositif de réunir une première composante liquide et une deuxième composante rigide ou liquide au moyen de vide sous des conditions stériles Expired - Lifetime EP0737467B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19513666 1995-04-11
DE1995113666 DE19513666C1 (de) 1995-04-11 1995-04-11 Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen

Publications (2)

Publication Number Publication Date
EP0737467A1 true EP0737467A1 (fr) 1996-10-16
EP0737467B1 EP0737467B1 (fr) 1999-06-02

Family

ID=7759443

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19960103858 Expired - Lifetime EP0737467B1 (fr) 1995-04-11 1996-03-12 Dispositif de réunir une première composante liquide et une deuxième composante rigide ou liquide au moyen de vide sous des conditions stériles

Country Status (12)

Country Link
US (1) US5743312A (fr)
EP (1) EP0737467B1 (fr)
JP (2) JP3228496B2 (fr)
KR (1) KR100388864B1 (fr)
AT (1) ATE180663T1 (fr)
AU (1) AU697521B2 (fr)
CA (1) CA2173823C (fr)
DE (2) DE19513666C1 (fr)
DK (1) DK0737467T3 (fr)
ES (1) ES2134527T3 (fr)
GR (1) GR3030958T3 (fr)
ZA (1) ZA962802B (fr)

Cited By (59)

* Cited by examiner, † Cited by third party
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EP1287804A2 (fr) 2001-08-31 2003-03-05 Aventis Behring GmbH Dispositif pour mettre ensemble des composants dans des conditions stériles
EP1372852A1 (fr) * 2001-03-08 2004-01-02 Exelixis, Inc. Appareil a puits multiples
AT503915B1 (de) * 2006-06-21 2008-02-15 Friedrich Ing Pipelka Transfervorrichtung
WO2011104711A1 (fr) * 2010-02-24 2011-09-01 Medimop Medical Projects Ltd Ensemble de transfert de fluide avec mécanisme d'aération
US8051884B2 (en) 2006-07-27 2011-11-08 Csl Behring Gmbh Device for combining components by means of negative pressure under sterile conditions
US8066688B2 (en) 2004-04-29 2011-11-29 Medimop Medical Projects Ltd. Liquid drug medical device
US8070739B2 (en) 2005-08-11 2011-12-06 Medimop Medical Projects Ltd. Liquid drug transfer devices for failsafe correct snap fitting onto medicinal vials
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US10765604B2 (en) 2016-05-24 2020-09-08 West Pharma. Services IL, Ltd. Drug vial adapter assemblages including vented drug vial adapter and vented liquid vial adapter
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US10918796B2 (en) 2015-07-03 2021-02-16 Ferrosan Medical Devices A/S Syringe for mixing two components and for retaining a vacuum in a storage condition
US10945921B2 (en) 2017-03-29 2021-03-16 West Pharma. Services IL, Ltd. User actuated liquid drug transfer devices for use in ready-to-use (RTU) liquid drug transfer assemblages
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US11046818B2 (en) 2014-10-13 2021-06-29 Ferrosan Medical Devices A/S Dry composition for use in haemostasis and wound healing
US11109849B2 (en) 2012-03-06 2021-09-07 Ferrosan Medical Devices A/S Pressurized container containing haemostatic paste
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US5743312A (en) 1998-04-28
JP3704295B2 (ja) 2005-10-12
DE59602051D1 (de) 1999-07-08
CA2173823A1 (fr) 1996-10-12
ZA962802B (en) 1996-10-11
GR3030958T3 (en) 1999-11-30
KR100388864B1 (ko) 2004-03-19
DK0737467T3 (da) 1999-11-29
JP3228496B2 (ja) 2001-11-12
EP0737467B1 (fr) 1999-06-02
AU5053996A (en) 1996-10-24
ES2134527T3 (es) 1999-10-01
DE19513666C1 (de) 1996-11-28
JPH08280778A (ja) 1996-10-29
JP2001333961A (ja) 2001-12-04
KR960037033A (ko) 1996-11-19
ATE180663T1 (de) 1999-06-15
AU697521B2 (en) 1998-10-08
CA2173823C (fr) 2006-06-20

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