EP1287804B1 - Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen - Google Patents

Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen Download PDF

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Publication number
EP1287804B1
EP1287804B1 EP20020017985 EP02017985A EP1287804B1 EP 1287804 B1 EP1287804 B1 EP 1287804B1 EP 20020017985 EP20020017985 EP 20020017985 EP 02017985 A EP02017985 A EP 02017985A EP 1287804 B1 EP1287804 B1 EP 1287804B1
Authority
EP
European Patent Office
Prior art keywords
hollow body
container
cannula
cannula holder
closure
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
EP20020017985
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1287804A2 (de
EP1287804A3 (de
Inventor
Thomas Pfeifer
Dietmar Palm
Michael Becker
Michael Seipp
Rainer Wabnegg
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.)
CSL Behring GmbH
Original Assignee
CSL Behring GmbH Deutschland
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 CSL Behring GmbH Deutschland filed Critical CSL Behring GmbH Deutschland
Publication of EP1287804A2 publication Critical patent/EP1287804A2/de
Publication of EP1287804A3 publication Critical patent/EP1287804A3/de
Application granted granted Critical
Publication of EP1287804B1 publication Critical patent/EP1287804B1/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
    • 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
    • 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
    • A61J1/2055—Connecting means having gripping means

Definitions

  • the invention relates to a device for combining a liquid component accommodated in a first container and a solid or liquid component received in a second container under sterile conditions.
  • Such a preassemblable device is known from the prior art. It is a device for passing a solvent from a bottle into a second bottle containing a pharmaceutical product to dissolve the product.
  • a transfer system is classified as a disposable medical device.
  • the two glass bottles are preassembled in the transfer device. Sterile packaging ensures that storage of the reconstituted product can take up to 36 hours.
  • a device of the type mentioned is in the EP 0 737 467 A1 described.
  • a secured, directed transfer is achieved by first piercing the closure of the first container containing the liquid component by means of a cannula and then displacing a cannula carrier receiving the cannula by means of this container in the direction of the second container receiving the solid or liquid component so that its closure is pierced by means of the cannula.
  • the cannula carrier takes a single cannula, which is sufficient for the merging of the components, as prevails before the piercing of the second container in this vacuum.
  • the cannula carrier is formed as a plate-shaped, perpendicular to the longitudinal direction of the two containers receiving hollow body oriented body which is connected via retaining webs with the inner wall of the hollow body, wherein the holding webs are rupturable by applying a manual force that is greater than the penetration force of the cannula Piercing the sealing plug of the initially opened container.
  • a disadvantage of this device is that the cannula carrier initially firmly connected to the hollow body is not defined separated from the hollow body.
  • the type of force introduction possibly an asymmetrical introduction of force, first rupture holding webs in an area of the cannula carrier, which involves the risk that the cannula carrier and thus the cannula in a tilted with respect to the longitudinal direction of the two containers position.
  • the result is that in particular the closure of the second container is not exactly pierced and problems arise when passing the liquid, in particular under the aspect of the applied vacuum.
  • the invention proposes according to the claims 1 and 4, two basic designs of the device.
  • a first cylindrical hollow body for receiving the first container in the region of the closure in a receiving opening of this hollow body and a second cylindrical hollow body for receiving the second container in the region of the closure in provided a diametrically arranged receiving opening.
  • the first hollow body and the cannula carrier are thus not separable, they represent a permanent assembly.
  • the cup-shaped design of the assembly ensures that the assembly, especially in the region of the first hollow body, is precisely guided in the second hollow body.
  • the cannula carrier forms the bottom of the pot and the first hollow body, the pot wall, whereby the first hollow body is not extended beyond the cannula carrier out.
  • the pot wall should have at least one guide section which cooperates with at least one guide section of the second hollow body. Due to the precise guidance of the assembly due to its cup-shaped design in the second hollow body ensures that the assembly and thus the cannula support does not tilt.
  • the cannula In a displacement movement of the cannula carrier, the cannula is defined in the longitudinal direction of the two hollow body moves by moving the first container in the direction of the second container and pierces the shutter.
  • the cannula holder takes the cannula firmly, so that it is not displaceable in the longitudinal direction.
  • only one cannula is received by the cannula carrier, wherein there is a vacuum in the second container.
  • the liquid component located in the first container passes into the second container due to the vacuum mixes with the solid or liquid component located there under sterile conditions.
  • the terms "cannula carrier” and “cannula” are to be understood comprehensively.
  • the cannula carrier and the cannula can form two separate components, wherein the cannula carrier is made in particular of plastic and the cannula in particular of metal. But it is quite conceivable to make the cannula carrier and the cannula in one piece, wherein the cannula is designed in the manner of a mandrel or spikes. Preferably, this assembly is made of plastic.
  • the spike / spike has one or two passages according to the circumstances. If there is vacuum in the second bottle, one passage is sufficient.
  • the two hollow bodies are inserted into each other and form the first hollow body and a cup-shaped cannula carrier with at least one of this cannula received separate components, wherein the first hollow body and the cannula carrier inserted into each other and in Guided longitudinal direction of the two hollow bodies are displaceable relative to each other.
  • the first hollow body and the cannula carrier do not form a structural unit. Instead, the cannula carrier, in order to ensure the precise guidance during its displacement, cup-shaped.
  • the first hollow body serves to receive the first container, while the cannula carrier serves to mount the cannula and its precise guidance in the longitudinal direction of the two hollow bodies.
  • the function of the storage of the first hollow body and the storage of the cannula is thus shifted in this design to two basic components, in contrast to the first solution.
  • the cannula carrier may well accommodate more than one cannula, depending on the application.
  • the pot wall should have at least one guide section which cooperates with at least one guide section of the first hollow body.
  • the first hollow body is mounted immovably in inserted in this first container in the second hollow body. If the first container is inserted into the first hollow body, only the advancement of the cup-shaped cannula carrier takes place when advancing the first container.
  • the first hollow body or the cup-shaped cannula carrier forming a structural unit with the cannula carrier has latching means for locking in different positions of the cannula carrier in complementary latching means of the second hollow body. These locking means ensure a defined displacement of the cannula holder and thus the cannula safely. If the closure of the first container is to be pierced before the cannula carrier is advanced and before it comes into contact with the closure of the second container, the detent of the cannula holder in this position must be dimensioned so that it is in contact of the closure of the first container the cannula does not move.
  • the puncture resistance of the closure of the second container is greater than that of the closure of the first container, so that the closure of the second container brings about the resistance with respect to the cannula which, when the first container is advanced, causes the latter Lock is punctured. In this case, the aforementioned detent would not be required.
  • the second detent serves to fix the cannula carrier or a component connected thereto in the maximally advanced position. It ensures that when removing the second container from the second hollow body of the cannula carrier is not tightened and therefore the cannula is pulled out of the closure of the second container.
  • Essential aspects of the device according to the invention are thus in handling safety and robustness in the application by a new design of the cannula holder, which is no longer firmly connected to a cylindrical hollow body and is no longer designed as a disc.
  • the design as a "pot” allows a much stronger guided movement when activated according to the principle "piston in the cylinder".
  • the activation of the device takes place in a vertically oriented position by pressure on the first container located above.
  • the first and / or second hollow body is formed segment-shaped in the region of its container-side end.
  • the segments form in particular spreading tabs, which can embrace a crimp cap of the respective container.
  • the device is used in particular in connection with containers which are designed as vials. It is preferably glass vials with a filling volume of 1 to 10 ml.
  • the device has a visual endpoint display, in which by viewing window reaching the end position of the cannula holder and thus the puncturing of the closure of the second container can be traced by means of the cannula.
  • the second hollow body is provided for this purpose laterally with the or the viewing windows.
  • the device For immediate use, the device, that is, with the two pre-assembled in the hollow containers in a package, especially a soft plastic packaging, sealed. It thus exists during the reconstitution procedure There is no risk of microbiological contamination since the transfer process can take place within the sterile outer packaging and also allows storage of the reconstituted product under sterile conditions.
  • the device according to the invention also prevents the handling of cannulas with freely accessible needle tips. There is no risk of injury during removal of the product bottle after reconstitution because the cannula carrier is retained in the device.
  • the device is immediately available because of the pre-assembly of the relevant components. Within a short time, the liquid can be transferred from the first to the second container. This requires a considerable time savings during the preparation process.
  • the reconstitution can either be prepared beforehand by a single person or take place directly in the sterile area of an operating room.
  • FIGS. 1 and 2 illustrate the device according to the invention, also referred to as the transfer system 1, in a three-part embodiment.
  • a first hollow body 2 serves for the displaceable reception of a cup-shaped cannula carrier 3 and can be inserted into the second hollow body 4.
  • the hollow body 2 serves as a holder for a solvent bottle and is provided for this purpose with various parallel to the longitudinal axis of the cylindrical hollow body 2 arranged flexible segments 5. These carry inwardly directed beads 6.
  • the opening 7 of the hollow body 2, which is the top of the transfer system when using the transfer, serves to accommodate the solvent bottle.
  • In the region of the lower opening 8 of the hollow body 2 is provided with an inner guide portion 9 for the cannula carrier 3 received by this, which has an outer complementary guide surface 10, so that the cannula carrier 3 is guided in the hollow body 2 with little play.
  • the cup-shaped cannula support 3 receives in the region of its bottom portion 11 fixed to a central, axially directed transfer cannula 12, which is provided with pointed ends.
  • the length of the transfer cannula 12 is dimensioned so that their respective projections, with respect to the bottom portion 1 of the cannula support 3, sufficient to pierce the closures of the containers cooperating with the device.
  • the second hollow body 4 serves to receive the first hollow body 2 and the cannula carrier 3 in its advanced position.
  • the relative to the position of use of the device lower end of the hollow body 4 is provided according to the design of the hollow body 2 with flexible segments 13, which in turn have inwardly directed beads 14.
  • the second container which receives the solid or liquid component, inserted into the hollow body 4.
  • the hollow body 4 is widened so that, when the hollow body 2 is inserted in it, its flexible segments have sufficient space to be spread outwards.
  • the hollow body 2 is held in the hollow body 4 in the region of its lower, outer guide section 17, which is provided with a circumferential one Locking groove 18 is provided, in which in the region of the complementary inner guide portion 19 a local circumferential locking projection 20 engages. In the inserted position of the hollow body 2, this is thus fixed relative to the hollow body 4.
  • the cannula support 3 has in the region of its outer guide portion 10 has a circumferential latching projection 21, which cooperates in the largely remote from the bottom opening 11 position with an extension 22 in the hollow body 4. If the cannula carrier 3 is acted upon by applying a force directed in the direction of the opening 15, the cannula carrier 3 is advanced until the latching projection 21 rests with a latching groove 23 of the hollow body 4 located further in the front in the hollow body 4. In this position, the cannula carrier 3 rests with its bottom portion 11 against a circumferential annular projection 24 of the hollow body 4.
  • FIG. 1 illustrates the mounting state of the transfer system 1 when inserted into the hollow body 4 hollow body 2, before advancing the cannula holder 3 in the direction of the opening 15 in the hollow body 4th
  • FIG. 3 shows the different steps in the assembly and in the activation of the transfer system 1.
  • step a is the Einzelteilildwolf according to FIG. 2 illustrates, further provided for insertion into the hollow body 2 glass bottle 25 which receives the solvent.
  • the bottle 25 is provided with an elastic, pierceable closure 26 and has a crimp cap 27 in the region of the closure.
  • the other, the fixed or designed liquid component receiving glass bottle 28 which can be inserted from below into the hollow body 4.
  • orientation shown - glass bottle top 25 and glass bottle bottom 28 - is, starting from the mounting state of the transfer system 1 according to FIG. 1 or mounting condition b. in FIG. 3 , the glass bottle 25 inserted into the hollow body 2 and the glass bottle 28 in the hollow body 4.
  • FIG. 3 illustrates the beads 6 of the segments 5 and the beads 14 of the segments 13, the bottles 25 and 28, wherein the bottle 28 abuts the annular projection 24 of the hollow body 4. If the two bottles 25 and 28 are now pressed towards one another or the glass bottle 25 is pressed further into the hollow body 2, the cannula 12 of the cannula holder 3 remaining in its position pierces the closure 26 of the bottle 25, the bottle having a greater diameter during advancement of the bottle Bottle body, the segments 5 of the hollow body 1 are spread outwards. This condition is too d. in FIG. 3 illustrated.
  • FIGS. 4 and 5 is different from the one after the FIGS. 1 and 2 in that instead of the two components - hollow body 2 and cannula carrier 3 - a component 29 is provided, which unites the function of these two components in itself.
  • Matching components are in the FIGS. 4 and 5 as well as the functional representation after FIG. 6 for the sake of simplicity designated by the same reference numerals.
  • the assembly 29 is pot-shaped and is formed by the cylindrical hollow body 2 and the cannula carrier 3.
  • the assembly 29 is provided with an outer circumferential locking projection 30, whose function is that of the locking projection 21 on the cannula carrier 3 in the embodiment according to the FIGS. 1 and 2 equivalent.
  • the outer guide portion 31 of the assembly 29 cooperates with the inner guide portion 32 of the hollow body 4, which is provided in the two functional positions of the cannula holder 3 of the assembly 29 with inner locking grooves 33 and 34, in their function of the extension 22 and the locking groove 23 correspond to the hollow body 2 in the embodiment described above.
  • the bottles 25 and 28 inserted into this, wherein the upper bottle 25 engages with its crimp cap 27 in a circumferential recess 35 of the flexible segments 5 of the assembly 29.
  • the segments 5 are spread over the bottle body to the outside and the crimp cap 27 of the bottle 25 against the cannula support 3, in particular in the region of the projection 36 which carries the cannula 12 moves.
  • the assembly 29 is moved out with its locking projection 30 from the locking groove 33 of the hollow body 4.
  • the lower end position of the cannula holder 3 is to e. in FIG.
  • FIGS. 7A to 7D illustrate a sealed in a blister foil transfer system 1 with the bottles inserted therein 25 and 28, in a state as in the Figures 3 and 6 to the stage c. is illustrated.
  • the Blister sheet 37 is welded to a sealing paper 38, which is preferably continuous for a sterilizing agent.
  • FIG. 7A shows the arrangement in a plan view
  • FIG. 7B this in a side view
  • the Figures 7C and 7D make cuts according to the lines AA and BB in FIG. 7A represents.

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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)
  • External Artificial Organs (AREA)
  • Sampling And Sample Adjustment (AREA)
EP20020017985 2001-08-31 2002-08-10 Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen Expired - Lifetime EP1287804B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10142450 2001-08-31
DE2001142450 DE10142450C1 (de) 2001-08-31 2001-08-31 Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen

Publications (3)

Publication Number Publication Date
EP1287804A2 EP1287804A2 (de) 2003-03-05
EP1287804A3 EP1287804A3 (de) 2003-10-29
EP1287804B1 true EP1287804B1 (de) 2012-02-01

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP20020017985 Expired - Lifetime EP1287804B1 (de) 2001-08-31 2002-08-10 Vorrichtung zum Zusammenführen von Komponenten unter sterilen Bedingungen

Country Status (11)

Country Link
US (1) US8172824B2 (ja)
EP (1) EP1287804B1 (ja)
JP (1) JP4359030B2 (ja)
KR (1) KR100895418B1 (ja)
AT (1) ATE543482T1 (ja)
AU (1) AU2002300778B2 (ja)
CA (1) CA2399826C (ja)
DE (1) DE10142450C1 (ja)
DK (1) DK1287804T3 (ja)
ES (1) ES2380655T3 (ja)
MX (1) MXPA02007786A (ja)

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JP6978428B2 (ja) * 2016-11-21 2021-12-08 テルモ株式会社 薬液充填ユニット、薬液充填セット、および充填アダプタ
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IL254802A0 (en) 2017-09-29 2017-12-31 Medimop Medical Projects Ltd A device with two vial adapters includes two identical perforated vial adapters
CN108433816B (zh) * 2018-04-17 2020-08-11 陕西省人民医院 一种用于医疗器械的可调整型放置架
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JP2023546374A (ja) 2020-10-09 2023-11-02 アイシーユー・メディカル・インコーポレーテッド 流体移送デバイスおよびそれのための使用の方法
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DE10142450C1 (de) 2003-06-18
MXPA02007786A (es) 2004-07-16
CA2399826C (en) 2011-09-27
DK1287804T3 (da) 2012-05-07
JP4359030B2 (ja) 2009-11-04
EP1287804A2 (de) 2003-03-05
ES2380655T3 (es) 2012-05-17
EP1287804A3 (de) 2003-10-29
US20030069538A1 (en) 2003-04-10
ATE543482T1 (de) 2012-02-15
US8172824B2 (en) 2012-05-08
AU2002300778B2 (en) 2008-01-31
KR100895418B1 (ko) 2009-05-07
JP2003126221A (ja) 2003-05-07
CA2399826A1 (en) 2003-02-28
KR20030019186A (ko) 2003-03-06

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