EP0737467B1 - Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen - Google Patents

Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen Download PDF

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Publication number
EP0737467B1
EP0737467B1 EP19960103858 EP96103858A EP0737467B1 EP 0737467 B1 EP0737467 B1 EP 0737467B1 EP 19960103858 EP19960103858 EP 19960103858 EP 96103858 A EP96103858 A EP 96103858A EP 0737467 B1 EP0737467 B1 EP 0737467B1
Authority
EP
European Patent Office
Prior art keywords
hollow body
cannula
container
cannula holder
holder
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.)
Expired - Lifetime
Application number
EP19960103858
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0737467A1 (de
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
Centeon Pharma GmbH
Axel Von Brand 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
Application filed by Centeon Pharma GmbH, Axel Von Brand GmbH filed Critical Centeon Pharma GmbH
Publication of EP0737467A1 publication Critical patent/EP0737467A1/de
Application granted granted Critical
Publication of EP0737467B1 publication Critical patent/EP0737467B1/de
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 merging a first liquid and a second solid or liquid component by means of negative pressure sterile conditions, with a first receiving the first component Container and a receiving the second component, under vacuum standing second container, and a cylindrical hollow body for receiving of the first container in the area of its closure in a first Hollow body opening and a second, arranged diametrically to this Hollow body opening, for receiving the second container in the area thereof Closure, and at least one stored in the hollow body and in it Longitudinally displaceable cannula for piercing the containers each sealing plug, the cannula in one Cannula holder is stored.
  • Such a device that is part of a pre-assembled system for Transfer of liquids forms is known from DE 38 17 101 A1.
  • the System allows the second container with the attached device in the Bring to trade so that liquid can be transferred to this second container only the first container to the through the second container and the Device formed unit must be plugged.
  • the sliding Storage of the cannula in the hollow body and in the path of the cannula holder protruding overrun resistance ensure that the inserted in the hollow body second container is connected to this, but not in contact with the Cannula arrives. Only after piercing the liquid absorbing first container is the further insertion of the container neck of the first Overrun container overrun resistance and the plug of the pierced the second container, leaving the inside of the two containers is connected by means of the cannula.
  • the known device is both on the cannula holder and on one Part of the hollow body-forming bearing sleeve is a circumferential projection intended.
  • the resistance resulting from the contact of the two projections to drive over the bearing sleeve-side projection is larger than that Penetration resistance of the cannula when penetrating into the plug of the first container.
  • the disadvantage here is that the formation of the parts with the Projections an exact dimensioning of the projection outer diameter of the Needle carrier and projection inner diameter of the bearing sleeve required to the To achieve successive piercing of the sealing plugs of the containers.
  • the projections also require increased manufacturing costs Device related to the manufacture of the cannula holder and the hollow body, otherwise the assembly of the device in the area of the cannula holder is right complex.
  • the problem is solved with a device of the type mentioned in that the cannula holder as a plate-shaped, perpendicular to the longitudinal direction of the hollow body oriented body is formed, the holding webs with the Inner wall of the hollow body is connected, the holding webs through Applying a manual force that is greater than that Penetration force of the cannula when piercing the plug of the first Container.
  • the cannula carrier is thus inserted into the cannula the stopper of the second container by means of the plate-shaped Retaining bars are fixed to the inner wall of the hollow body.
  • a shift in Cannula is therefore only possible if the holding bars have been applied beforehand the manual force were torn. It is therefore a safe sequential Sequence of movement guaranteed.
  • the design of the device enables their simple design by, as appropriate, except for the cannula Plastic injection molded part is designed.
  • the Cannula holder with directed towards the inner wall of the hollow body Leadership approaches. These allow after separating the Retaining webs a relatively tilt-free guidance of the cannula holder relative to the inner wall of the hollow body, thus a largely exact guidance of the Cannula in the puncture area to the second container, the cannula also in the sealing plug of the first container.
  • the hollow body advantageously has an opening with a circular cross section.
  • the cannula holder has, for example, the shape of an equilateral triangle, with three Guiding approaches that are in the middle of the triangle sides of the Cannula holder are connected to this.
  • a circular cannula holder are preferably four, each offset by 90 degrees to each other Guide approaches connected to the circumference of the cannula holder.
  • the Guiding lugs can be concentric on the outside radially and in the longitudinal direction of the hollow body have extending guide tabs.
  • a preferred development of the invention provides that with the inner wall of the hollow body are connected in the longitudinal direction extending lugs, between which the guide lugs or the corners of the cannula holder are arranged.
  • the respective management approach should be via a middle bar be connected to the cannula holder and two guide approaches each Reach behind the leadership approach in the area of the center bar.
  • the design of the Hollow body with guide lugs requires a defined positioning of the Cannula holder relative to the hollow body during its displacement in the longitudinal direction and also prevents relative rotation or tilting of the Cannula holder to the hollow body.
  • 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 the generally enlarged, voluminous area of the Contains at least partially with more or less large distance, so that a tilting of the container in the hollow body is excluded. From This is particularly important for the container that contains the substance Vacuum or vacuum conditions, so when transferring the Liquid in this container does not have to be actively carried, but only this the other, the liquid-absorbing container is required.
  • the elongated section of the hollow body expediently has one Inner diameter that is slightly larger than the outer diameter of the Container. This will not only prevent the accidental tilting of the Prevented container, but led the container defined.
  • the device with the two containers forms a pre-assembled, sterile packaged system in which the two containers are kept out of contact with the cannula in the cylindrical hollow body and a Packaging that encloses the containers and the hollow body sterile.
  • 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 negative pressure 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 holder 9 is arranged inside 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 by the pharmaceutical manufacturer in a peelable outer packaging 14, as is 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 tapping the respective containers.
  • Figures 3a to 3c illustrate the processes around the components merge.
  • Figure 3a illustrates the pre-assembled system as shown in Figure 1 is shown. Proceeding from this, the liquid absorbing Bottle 1 further inserted into the hollow body 3, the cannula 8 the Plug of bottle 1, which is made of rubber, penetrates. This is possible because the penetration or penetration force of the cannula 8 in or by the rubber stopper of the bottle 1 is less than the force required is connected to the hollow body 3 via the holding webs 13 Separate cannula holder 9 from this.
  • Figures 4a and 4b illustrate those in Figures 1 to 3c Transfer system described device for merging the components in detail.
  • the hollow body 3 is in the Area of the hollow body opening 6 as a ring 34 with only thin points interconnected holding webs 16 are formed.
  • the Cannula holder 9 essentially has the shape of a circle and is four Guide approaches 35 provided on the circumference of the cannula holder 9 each 90 ° offset from each other.
  • the leadership approaches 35 have a radially outer concentric to the cannula 8 and in the longitudinal direction of the Hollow body 3 extending guide surface 36. This is a short distance away arranged to the inner wall 30 of the hollow body 3, so that the cannula holder 9th after tearing the retaining webs 13 free of play and thus tilt-proof in the hollow body 3 is movable.
  • the hollow body 3 is inside with four, in the longitudinal direction of the hollow body 3 extending, each offset by 90 ° to each other arranged ribs 37 which provide the receiving diameter of the Specify the hollow body 3 for the bottle 1 and thus an exact positioning of the Ensure bottle 1, the insertion of this bottle 1 because of it System with its crimp cap 4 on the ribs 37 with little effort can be done.
  • the ribs 37 pass through recesses 38 between the Leadership approaches 35.
  • the cannula holder 9 has a essentially the shape of an equilateral triangle and there are three Guide approaches 35 provided in the center of the triangular sides of the Cannula holder 9 are connected to this.
  • Guide approaches 35 With the inner wall 30 of Hollow body 3 are wing-like guide lugs extending in its longitudinal direction 12, between which the guide lugs 35 of the cannula holder 9 are arranged.
  • the respective guide approach 35 is connected via a central web 39 connected to the cannula holder 9 and engage behind two adjacent ones Guiding approaches 12 the guiding approach 35 in the area of the central web 39.
  • everyone Guide projection 35 is connected to the hollow body 3 via a retaining web 13.
  • the triangular dimension of the cannula holder 9 is chosen so that its tips are positioned with minimal play to the inner wall 30 of the hollow body 3 what otherwise also for the position of the guide surface 36 of the respective Guide approach 35 and inner wall 30 of the hollow body 3 applies.
  • Neighbors Guide lugs 12 are arranged diverging from the inner wall 30 so that they take a corner 40 of the cannula holder 9 between them.
  • the hollow body opening has 7 (compared to the embodiment according to FIG. 6a) a greater longitudinal extent on. This is achieved by extending the opening Ring section 45 of the hollow body 3.
  • the inner diameter of the ring section is dimensioned slightly larger than the outer diameter of the bottle 2 in 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 section 45 extends to the side of the flange section 46. This causes a tilting of the Bottle 2 effectively prevented in the hollow body opening 7.
  • the upper Hollow body opening 6 is designed accordingly, that is, it also takes place there a guidance of the bottle 1 in the area of its bottle section 46, thus hers 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 5a and 5b is used 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 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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Package Specialized In Special Use (AREA)
  • Loading And Unloading Of Fuel Tanks Or Ships (AREA)
  • Closing Of Containers (AREA)
  • External Artificial Organs (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
EP19960103858 1995-04-11 1996-03-12 Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen Expired - Lifetime EP0737467B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
DE19513666 1995-04-11

Publications (2)

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

Family

ID=7759443

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19960103858 Expired - Lifetime EP0737467B1 (de) 1995-04-11 1996-03-12 Vorrichtung zum Zusammenführen einer ersten flüssigen und einer zweiten festen oder flüssigen Komponente mittels Unterdruck unter sterilen Bedingungen

Country Status (12)

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

Cited By (7)

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DE10142450C1 (de) * 2001-08-31 2003-06-18 Aventis Behring Gmbh Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen
US7923431B2 (en) 2001-12-21 2011-04-12 Ferrosan Medical Devices A/S Haemostatic kit, a method of preparing a haemostatic agent and a method of promoting haemostatis
US7923031B2 (en) 2004-01-30 2011-04-12 Ferrosan Medical Devices A/S Haemostatic sprays and compositions
US7955288B2 (en) 2002-12-11 2011-06-07 Ferrosan Medical Devices A/S Gelatine-based materials as swabs
US8021684B2 (en) 2004-07-09 2011-09-20 Ferrosan Medical Devices A/S Haemostatic composition comprising hyaluronic acid
US8642831B2 (en) 2008-02-29 2014-02-04 Ferrosan Medical Devices A/S Device for promotion of hemostasis and/or wound healing
US9265858B2 (en) 2012-06-12 2016-02-23 Ferrosan Medical Devices A/S Dry haemostatic composition

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DE10022835B4 (de) * 2000-05-10 2004-10-28 Kellermann, Johann Mechanismus zum Vermischen von Flüssigkeiten und Granulaten
US6558365B2 (en) * 2001-01-03 2003-05-06 Medimop Medical Projects, Ltd. Fluid transfer device
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US7456024B2 (en) * 2001-08-29 2008-11-25 Hexal Pharma Gmbh Method and device for preparing a sample of biological origin in order to determine at least one constituent contained therein
PL371200A1 (en) * 2001-12-21 2005-06-13 Ferrosan A/S A haemostatic kit, a method of preparing a haemostatic agent and a method of promoting haemostatis
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US8172824B2 (en) 2001-08-31 2012-05-08 Csl Behring Gmbh Apparatus for combining components under sterile conditions
US7923431B2 (en) 2001-12-21 2011-04-12 Ferrosan Medical Devices A/S Haemostatic kit, a method of preparing a haemostatic agent and a method of promoting haemostatis
US8283320B2 (en) 2001-12-21 2012-10-09 Ferrosan Medical Devices A/S Haemostatic kit, a method of preparing a haemostatic agent and a method of promoting haemostasis
US7955288B2 (en) 2002-12-11 2011-06-07 Ferrosan Medical Devices A/S Gelatine-based materials as swabs
US7923031B2 (en) 2004-01-30 2011-04-12 Ferrosan Medical Devices A/S Haemostatic sprays and compositions
US8021684B2 (en) 2004-07-09 2011-09-20 Ferrosan Medical Devices A/S Haemostatic composition comprising hyaluronic acid
US8642831B2 (en) 2008-02-29 2014-02-04 Ferrosan Medical Devices A/S Device for promotion of hemostasis and/or wound healing
US9533069B2 (en) 2008-02-29 2017-01-03 Ferrosan Medical Devices A/S Device for promotion of hemostasis and/or wound healing
US9265858B2 (en) 2012-06-12 2016-02-23 Ferrosan Medical Devices A/S Dry haemostatic composition

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DK0737467T3 (da) 1999-11-29
ZA962802B (en) 1996-10-11
CA2173823C (en) 2006-06-20
JP3228496B2 (ja) 2001-11-12
ES2134527T3 (es) 1999-10-01
JPH08280778A (ja) 1996-10-29
ATE180663T1 (de) 1999-06-15
AU5053996A (en) 1996-10-24
AU697521B2 (en) 1998-10-08
DE19513666C1 (de) 1996-11-28
CA2173823A1 (en) 1996-10-12
DE59602051D1 (de) 1999-07-08
JP2001333961A (ja) 2001-12-04
KR960037033A (ko) 1996-11-19
KR100388864B1 (ko) 2004-03-19
EP0737467A1 (de) 1996-10-16
US5743312A (en) 1998-04-28
GR3030958T3 (en) 1999-11-30
JP3704295B2 (ja) 2005-10-12

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