EP2194951B1 - Vorrichtung zum einführen eines medikaments in einen infusionsbehälter - Google Patents

Vorrichtung zum einführen eines medikaments in einen infusionsbehälter Download PDF

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Publication number
EP2194951B1
EP2194951B1 EP20080802711 EP08802711A EP2194951B1 EP 2194951 B1 EP2194951 B1 EP 2194951B1 EP 20080802711 EP20080802711 EP 20080802711 EP 08802711 A EP08802711 A EP 08802711A EP 2194951 B1 EP2194951 B1 EP 2194951B1
Authority
EP
European Patent Office
Prior art keywords
hollow
container
transfer cap
infusion
valve
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.)
Active
Application number
EP20080802711
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2194951A1 (de
Inventor
Karl-Heinz Proksch
Julian Titze
Helmut Freigang
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.)
B Braun Melsungen AG
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B Braun Melsungen 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 B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP2194951A1 publication Critical patent/EP2194951A1/de
Application granted granted Critical
Publication of EP2194951B1 publication Critical patent/EP2194951B1/de
Active 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • 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
    • A61J1/2058—Connecting means having multiple connecting ports

Definitions

  • the invention relates to a device for adding a medicament to an infusion solution in an infusion container according to the preamble of claim 1.
  • a device of this kind is made US 5 647 845 A known, wherein on a cylindrical transfer cap on the outer circumference in the region of a transverse to the axis of the transfer cap inserted, rotatable valve body an angled pipe piece is attached, to which an infusion set can be connected.
  • a connection can be established between the hollow mandrel attached to the transfer cap, which is inserted into the sealing area of an infusion container, and the angled tubular piece. At the exposed end of this pipe piece, contamination may occur during the handling of the device.
  • infusion solution is first forced into the medicament container by repeatedly compressing the flexible infusion container.
  • the assembly is rotated so that the infusion container at the bottom and the drug container is at the top, whereupon the contents of the drug container is sucked back into the infusion container by this again compressed and released several times.
  • the drug container with transfer cap is removed from the infusion container and the infusion set attached to the infusion container, whereupon the infusion can begin.
  • This procedure is associated with the risk of contamination of the infusion solution, because after removal of the medicament container, the removal opening of the infusion container is exposed and contaminating ambient air can penetrate into the infusion container.
  • the invention has for its object to form a device of this kind so that the admixing of the drug for infusion without the risk of contamination.
  • Another advantage is a simplification of handling, because the drug container does not need to be removed from the infusion container. As a result, the staff can read at any time on the basis of the drug container, which drug was added to the infusion solution.
  • Fig. 1 shows a bottle-shaped infusion container 1, which usually consists of transparent plastic and flexible wall sections, so that the infusion container 1 can be compressed to generate a pressure in the container, whereupon by releasing a negative pressure is generated by the elastic side walls Reset.
  • a bottleneck 1.2 On the lower side in the operating position of the infusion container is provided with a bottleneck 1.2, on which a transfer cap 2 is attached.
  • 3 is a medicament container, usually a glass bottle, which is inserted with its axis oblique to the axis of the infusion container 1 in the transfer cap 2.
  • 4 is a drip chamber of an infusion set, which is connected to the infusion container 1.
  • Fig. 1 shows the operating position of the device in which an infusion is carried out, wherein the drip chamber 4 is arranged with its axis substantially parallel to the axis of the infusion container 1 or perpendicular and not oblique.
  • Fig. 2 shows in a section a first embodiment of the transfer cap 2 in the in Fig. 1 reproduced operating position.
  • a sealing cap 1.3 is attached fluid-tight, which is provided with a pierceable seal area 1.4.
  • the transfer cap 2 via elastic latching sections 2.1 on a flange ( Fig. 1 ), which do not detachably overlap the edge of the sealing cap 1.3 without tools.
  • Placed overhead flange with the catches 2.1 is followed by a substantially hollow cylindrical section 2.2 of the transfer cap, on the underside in Fig.
  • a tubular approach 2.3 is formed so that its axis B is oblique to the axis A of the bottle neck 1.2 on the infusion container 1.
  • This tubular approach 2.3 forms a receiving device for the drug container 3, which engages with its bottleneck 3.1 in this tubular approach 2.3.
  • the tubular extension 2.3 is provided on its circumference with elastic hooks or notches 2.31, so that the provided with a flange or a crimp cap 3.1 of the medicine container 3 can engage in the tubular extension 2.3, whereupon the notches 2.31 the drug container 3 in the connecting position lock.
  • the transfer cap 2 is provided on the side facing the infusion container 1 with a hollow mandrel 2.4, which pierces the sealing region 1.4 of the sealing cap 1.3, when the transfer cap 2 is attached to the bottle neck 1.2 of the infusion container 1.
  • a further hollow dome 2.5 is arranged on the transfer cap 2 such that it forms a seal 3.2 of the medicament container 3 pierces when the drug container 3 is inserted into the tubular neck 2.3.
  • a valve is arranged in the transfer cap 2, which interrupts the connection between the two hollow domes 2.4 and 2.5 and releases the connection only upon the action of an actuating force.
  • the valve is designed as an elastic valve disc 5, which has three slots 5.1 in the middle region in a star shape.
  • This valve disc 5 is clamped on the circumference between annular shoulders, wherein an annular shoulder is formed on a partition wall 2.7 of the transfer cap 2, on which the hollow mandrel 2.4 is formed, and the opposite annular shoulder is formed on the flange of an element provided with the hollow dome 2.5, as Separate component is used in this embodiment in the transfer cap 2 and in the region of the partition wall 2.7.
  • the transfer cap 2 is laterally adjacent to the off-center and obliquely attached tubular approach 2.3 with a recess 2.6 ( Fig. 1 ), through which the sealing area 1.4 of the sealing cap 1.3 is exposed, so that the infusion set can be inserted with a hollow dome 4.1 at the drip chamber 4 through this recess 2.6 perpendicular to the sealing area 1.4.
  • infusion solution can flow from the infusion container 1 through the hollow dome 4.1 in the drip chamber 4, while the valve disc 5 keeps the connection between the infusion container 1 and drug container 3 is closed.
  • the transfer cap 2 with the tubular attachment 2.3 is first attached to the neck of the medicament container 3, so that the hollow mandrel 2.5 pierces the seal 3.2.
  • the transfer cap 2 is connected to the medicament container 3 such that it can not be detached from the transfer cap 2 without a tool.
  • the transfer cap 2 is attached to the sealed infusion container 1 with medicine container 3, so that the hollow mandrel 2.4 penetrates the seal area 1.4, as this Fig. 2a shows.
  • the infusion container 1 may be positioned with the bottle neck on the top, so that the transfer cap 2 and the medicament container 3 are attached to the infusion container 1 from above.
  • the closed valve 5 prevents it from leaking out of the medicament container 3.
  • the arrangement is 180 ° in the in Fig. 2a rotated position reproduced, which is pressed by repeated compression of the flexible walls of the infusion container 1 infusion solution in the drug container 3.
  • the valve disc 5 opens by bending between the slots 5.1 elastic valve lugs bend and allow a passage of infusion liquid to the drug container 3.
  • the arrangement is again rotated 180 ° in the in Fig. 2b rotated position reproduced, whereupon by repeated compression of the infusion container 1, the infusion solution admixed drug from the drug container 3 is sucked into the infusion container 1.
  • the valve disc 5 opens by the negative pressure generated in the infusion container 1 after releasing the compressed side walls of the infusion container. 1
  • the hollow mandrel 4.1 of the drip chamber 4 is inserted through the recess 2.6 in the transfer cap 2 into the sealing area 1.4 of the infusion container 1, whereupon the infusion in the in Fig. 1 starting position reproduced.
  • the connection between the drug container 3 and infusion container 1 is interrupted by the valve disc 5, because no forces acting on the valve disc 5. It can thus flow back no infusion solution in the underlying drug container 3.
  • the medicine container 3 is not detachably connected to the transfer cap 2 and remains in the in Fig. 1 and 2 reproduced position on the transfer cap 2, as long as the infusion is performed.
  • drug container 3 By remaining on the infusion device drug container 3 is immediately recognizable to the operator, which drug admixed to the infusion solution has been. Because the medicament container 3 is not released from the infusion container 1 or the transfer cap 2 after the mixing process, contamination in the connection area between the medicament container 3 and the infusion container 1 can not occur. After attaching the medicine container 3, the system remains closed.
  • the arranged in the transfer cap 2 valve between the obliquely arranged and separated hollow domes 2.4 and 2.5, which ensures that the medicament container 3 need not be removed, can be formed in various ways.
  • Fig. 3 shows a second embodiment with an actuatable by turning valve, wherein on the hollow mandrel 2.5, a valve disc 6 is formed, which is rotatably supported between detents on the partition wall 2.7 of the transfer cap 2 and eccentrically provided with a passage opening 6.1, with the mouth opening of the hollow dome 2.4 can be aligned.
  • Fig. 3 shows the closed position of the valve disc 6, in which a closed area of the valve disc 6 of the mouth opening of the hollow dome 2.4 is opposite.
  • Fig. 3a shows the connection position of the valve disc 6, in which the passage opening 6.1 is aligned with the hollow dome 2.4.
  • valve disc 6 can be rotated with hollow mandrel 2.5 formed thereon, a positive connection between seal 3.2 and hollow mandrel 2.5 is expediently formed in that the hollow mandrel 2.5, for example, has an oval cross-section.
  • the valve disc 6 can also be rotated into the open or closed position.
  • Fig. 4 shows a third embodiment with a displaceable in the axial direction of the tubular extension 2.3 valve element 7.
  • a neck 2.51 is formed on the hollow dome 2.5, which has a passage 2.52 ( Fig. 4a ), which can be closed and released by the displaceable valve element 7.
  • Fig. 4 shows the closed position and the Fig. 4a the open position in which the sleeve-shaped valve element 7 is displaced in the direction of the medicament container 3, so that the passageway 2.52 is released.
  • Fig. 5 shows a fourth embodiment of the valve between the obliquely arranged hollow mandrels 2.4 and 2.5 in the transfer cap 2, which has a rotatable valve body 8 with a protruding on the transfer cap 2 knob 8.1.
  • the shaft-shaped valve body 8 is rotatable in a transverse bore of a lug on the hollow mandrel 2.5 and provided with a passage opening 8.2, which can be aligned with the hollow mandrel 2.5 and a connection opening to the hollow mandrel 2.4, when the knob 8.1 is rotated in the marked by a mark 8.11 open position , Fig. 5a shows the open position.
  • the medicament container 3 is attached obliquely to the vertical in the operating position on the transfer cap 2, so that the flow path between the two hollow domes 2.4 and 2.5 can be kept as short as possible. But it is also possible to make the transfer cap 2 on the side of the medicament container 3 wider, so that the medicament container 3 can be positioned approximately perpendicular, ie with its axis B approximately parallel to the axis A of the infusion container 1. Although this results in a longer flow path between the two hollow domes 2.4 and 2.5 with the intermediate valve, but the flow path can be designed so that there is no interference with the mixing of the drug.
  • a valve element between the two hollow mandrels can be provided, which is transversely displaceable to the axes A, B of the infusion container 1 and the medicament container 3 for opening and closing the connection between the two containers in the transfer cap 2.
  • Fig. 6 shows the transfer cap 2 in various perspective views, wherein the hollow dome 2.5, which is formed on a separate component, which on the partition wall 2.7 (Fig. Fig. 6c ) is used in the Fig. 6b and 6c is not reproduced.
  • Fig. 8 and 9 show such Two-part embodiment of the transfer cap 2, wherein at the bottom of the tubular neck 2.3 in Fig. 9 Recesses 2.32 are formed at diametrically opposite locations, the corresponding locking projections 2.33 record at the upper periphery of the hollow cylindrical sections 2.2 when the tubular projection 2.3 is attached to the section 2.2.
  • Fig. 8 and 9 are the hollow domes 2.4 and 2.5 formed on the two elements 2.2 and 2.3 of the transfer cap 2, as this Fig. 8 shows.
  • the hollow mandrel 2.5 is formed on a partition wall 2.51 in the tubular extension 2.3 in such a way that a chamber 2.52 results between the hollow dome 2.5 and the valve 5.
  • 2.34 designated edge portion of the tubular extension 2.3 are in Fig. 9 reproduced recesses 2.32 formed.
  • valve in the form of the valve disc 5 is clamped between the two elements 2.2 and 2.3 between the partitions 2.7 and 2.51.
  • Fig. 8 and 9 are the in Fig. 2 reproduced notches 2.31 for receiving the medicament container 3 as a latching hook at opposite locations on the circumference of the tubular extension 2.3 formed as Fig. 9 shows.
  • At the hollow cylindrical section 2.2 are instead of the opposite latching sections 2.1 in Fig. 6b in the Fig. 8 and 9 adjacent latching sections formed so that a total of four locking sections 2.1 result.
  • the sealing area 1.4 at the removal opening of the infusion container 1 can be designed such that two adjacent sealing openings 1.41 and 1.42 are present in the cap 1.3, one of which is for the hollow dome 2.4 of the transfer cap 2 and the other for the hollow dome 4.1 of the drip chamber 4th is provided.
  • Fig. 7 shows such a shaped, approximately rectangular sealing area 1.4 on the infusion container 1, wherein the border of the rectangular portion 1.4 is part of the sealing cap 1.3.
  • an alignment device can be integrally formed on the transfer cap 2, by means of which the transfer cap 2 can only be attached to the infusion container 1 or to the sealing cap 1.3, that one of the openings 1.41, 1.42 under the recess 2.6 and the other is located under the hollow dome 2.4 of the transfer cap. In this way, incorrect positioning of the transfer cap 2 on the sealing cap 1.3 is prevented.
  • the medicament container 3 and the drip chamber 4 are arranged so that they lie with their axes substantially in one plane, as this Fig. 1 shows. It is also an embodiment possible in which the medicament container 3 and thus also the tubular approach 2.3 obliquely to the plane in Fig. 1 is arranged so that in a side view from right or left in Fig. 2 the medicament container 3 obliquely to the drip chamber 4 and obliquely to the plane in Fig. 2 lies.

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Closures For Containers (AREA)
EP20080802711 2007-10-01 2008-09-30 Vorrichtung zum einführen eines medikaments in einen infusionsbehälter Active EP2194951B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200710046951 DE102007046951B3 (de) 2007-10-01 2007-10-01 Vorrichtung zum Einführen eines Medikaments in einen Infusionsbehälter
PCT/EP2008/008283 WO2009046903A1 (de) 2007-10-01 2008-09-30 Vorrichtung zum einführen eines medikaments in einen infusionsbehälter

Publications (2)

Publication Number Publication Date
EP2194951A1 EP2194951A1 (de) 2010-06-16
EP2194951B1 true EP2194951B1 (de) 2014-02-26

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP20080802711 Active EP2194951B1 (de) 2007-10-01 2008-09-30 Vorrichtung zum einführen eines medikaments in einen infusionsbehälter

Country Status (9)

Country Link
US (1) US8647320B2 (ru)
EP (1) EP2194951B1 (ru)
CN (1) CN101815496B (ru)
BR (1) BRPI0817631B8 (ru)
DE (1) DE102007046951B3 (ru)
ES (1) ES2464994T3 (ru)
MY (1) MY156061A (ru)
RU (1) RU2485930C2 (ru)
WO (1) WO2009046903A1 (ru)

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EP2194951A1 (de) 2010-06-16
WO2009046903A1 (de) 2009-04-16
US8647320B2 (en) 2014-02-11
BRPI0817631B1 (pt) 2019-06-25
RU2485930C2 (ru) 2013-06-27
MY156061A (en) 2016-01-15
BRPI0817631A2 (pt) 2015-03-24
CN101815496A (zh) 2010-08-25
RU2010117377A (ru) 2011-11-10
BRPI0817631B8 (pt) 2021-06-22
DE102007046951B3 (de) 2009-02-26
ES2464994T3 (es) 2014-06-04
CN101815496B (zh) 2013-01-02
US20110004184A1 (en) 2011-01-06

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