EP2194951A1 - Dispositif pour introduire un médicament dans un flacon à perfusion - Google Patents

Dispositif pour introduire un médicament dans un flacon à perfusion

Info

Publication number
EP2194951A1
EP2194951A1 EP08802711A EP08802711A EP2194951A1 EP 2194951 A1 EP2194951 A1 EP 2194951A1 EP 08802711 A EP08802711 A EP 08802711A EP 08802711 A EP08802711 A EP 08802711A EP 2194951 A1 EP2194951 A1 EP 2194951A1
Authority
EP
European Patent Office
Prior art keywords
container
transfer cap
infusion
valve
hollow
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
EP08802711A
Other languages
German (de)
English (en)
Other versions
EP2194951B1 (fr
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
Original Assignee
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/fr
Application granted granted Critical
Publication of EP2194951B1 publication Critical patent/EP2194951B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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 introducing a medicament into an infusion container, which is provided with a sealed removal opening.
  • an infusion container with drip chamber Before an infusion container with drip chamber is attached to carry out the infusion, it is known to mix a drug to the infusion solution such that on the removal opening of the infusion container, a transfer cap with a hollow mandrel for piercing the seal is placed on the infusion container, the a receiving device for a medicament container.
  • 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. Thereafter, 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.
  • This object is achieved by the features of claim 1.
  • 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 from the drug container at any time, which drug was added to the infusion solution.
  • FIG. 1 is a perspective view of the infusion container with medicine container and drip chamber in the ready state for performing an infusion
  • FIG. 9 is a perspective view of the individual elements of the embodiment of FIG .. 8
  • FIG. 1 shows a bottle-shaped infusion container 1, which usually consists of transparent plastic and has flexible wall sections, so that the infusion container 1 can be compressed to generate a pressure in the container, whereupon a negative pressure is created by releasing the elastic sidewall. 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 and perpendicular and not oblique.
  • Fig. 2 shows in a section a first embodiment of the transfer cap 2 in the reproduced in Fig. 1 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 is fastened via elastic latching sections 2.1 to a flange section (FIG. 1) which does not detachably overlap the edge of the sealing cap 1.3 without tools.
  • a substantially hollow cylindrical section 2.2 of the transfer cap is followed by a substantially hollow cylindrical section 2.2 of the transfer cap, on the underside in Fig.
  • a tubular extension 2.3 is formed so that its axis B obliquely to the axis A of the bottle neck 1.2 is located 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 medicament container 3 can engage in the tubular approach 2.3, whereupon the notches 2.31 the medicament 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 hollow mandrel 2.4 In the area of this hollow mandrel 2.4, another hollow mandrel 2.5 is arranged on the transfer cap 2 in such a way that it forms a seal 3.2 of the medicament seal. ten thoughtsers 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 mandrels 2.4 and 2.5 and only releases the connection upon the action of an actuating force.
  • the valve is designed as an elastic valve disk 5, which has three slots 5.1 in the middle region in the shape of a star.
  • 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 mandrel 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 provided laterally next to the off-center and obliquely attached tubular extension 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 with a hollow mandrel 4.1 at the drip chamber 4 through this recess 2.6 can be inserted vertically into the seal area 1.4.
  • infusion solution can flow from the infusion container 1 through the hollow mandrel 4.1 into the drip chamber 4, while the valve disc 5 keeps the connection between the infusion container 1 and the medicament container 3 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 with medicament container 3 is attached to the sealed infusion container 1, so that the hollow mandrel 2.4 pierces the sealing area 1.4, as shown in FIG. 2a.
  • 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 assembly is rotated by 180 ° in the reproduced in Fig. 2a position, whereupon by repeated compression of the flexible walls of the infusion container 1 infusion solution is pressed into 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 by 180 ° in the reproduced in Fig. 2b position, 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 in the sealing area 1.4 of the infusion container 1, after which the infusion can begin in the reproduced in Fig. 1 position ,
  • 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 medicament container 3 is non-detachably connected to the transfer cap 2 and remains in the position shown in FIGS. 1 and 2 on the transfer cap 2 as long as the infusion is carried out.
  • the operator By means of the medicament container 3 remaining on the infusion device, the operator immediately recognizes which medicament is to be added to the infusion solution. was mixed. 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 mandrels 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 a valve actuated by turning, 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 is provided off-center with a passage opening 6.1 with the mouth opening of the hollow mandrel 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 mandrel 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 mandrel 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 valve element 7 displaceable in the axial direction of the tubular extension 2.3.
  • an extension 2.51 is formed on the hollow mandrel 2.5 and has a passage 2.52 (FIG. 4a) closed by the displaceable valve element 7 can be released.
  • FIG. 4 shows the closed position and
  • FIG. 4 a shows the open position in which the sleeve-shaped valve element 7 is displaced in the direction of the medicament container 3, so that the passage channel 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 into the marked by a mark 8.11 open position becomes.
  • 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 mandrels 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 mandrels 2.4 and 2.5 with the intermediate valve, but the flow path can be designed so that there is no interference with the admixing 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 mandrel 2.5, which is formed on a separate component which is inserted on the dividing wall 2.7 (FIG. 6c), is not reproduced in FIGS. 6b and 6c.
  • Figs. 8 and 9 show such Two-part embodiment of the transfer cap 2, wherein at the lower edge of the tubular Ansatz 2.3 in Fig. 9 recesses 2.32 are formed at diametrically opposite locations, the corresponding locking projections 2.33 record at the upper circumference of the hollow cylindrical sections 2.2 when the tubular projection 2.3 on section 2.2.
  • the hollow mandrels 2.4 and 2.5 are integrally formed on the two elements 2.2 and 2.3 of the transfer cap 2, as shown in FIG. 8.
  • the hollow mandrel 2.5 is formed on a partition 2.51 in the tubular extension 2.3 so that there is a chamber 2.52 between hollow mandrel 2.5 and valve 5.
  • recesses 2.32 are 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.
  • the detents 2.31 reproduced in FIG. 2 for receiving the medicament container 3 are designed as latching hooks at opposite locations on the circumference of the tubular extension 2.3, as FIG. 9 shows.
  • adjacent latching sections are formed such that a total of four latching sections 2.1 result.
  • the two hollow mandrels 2.4 and 2.5 are integrally formed on the transfer cap 2 and on the partition wall 2.7, wherein the valve mechanism can be inserted laterally between the two hollow mandrels similar to the reproduced in Fig. 5 design.
  • the sealing area 1.4 at the removal opening of the infusion container 1 can be designed so that two adjacent sealing holes 1.41 and 1.42 are present in the cap 1.3, one of which for the hollow mandrel 2.4 of the transfer cap 2 and the other for the hollow mandrel 4.1 of the drip chamber. 4 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 plugged onto the infusion container 1 or onto 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 mandrel 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 shown in FIG. 1. It is also an embodiment possible in which the medicament container 3 and thus also the tubular projection 2.3 is arranged obliquely to the plane of the drawing in Fig. 1, so that in a side view from the right or left in Fig. 2 of the drug container 3 obliquely to the drip chamber 4 and is oblique to the plane of the drawing in Fig. 2.

Landscapes

  • 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)

Abstract

L'invention se rapporte à un dispositif pour mélanger un médicament à une solution pour perfusion dans un flacon à perfusion (1) dont l'orifice d'écoulement est doté d'une zone d'étanchéité (1.4) comprenant un capuchon de transfert (2) pouvant être raccordé à l'ouverture d'écoulement du flacon à perfusion (1) ainsi qu'une aiguille creuse (2.4) pour perforer la zone d'étanchéité (1.4). Un système de réception (2.3) de flacon à médicament (3) est formé sur le capuchon de transfert (2) et présente une aiguille creuse (2.5) pour perforer un joint (3.2) situé sur le flacon à médicament (3) et une valve (5 ; 6 ; 7 ; 8) est agencée entre les deux aiguilles creuses (2.4, 2.5) dans le capuchon de transfert (2), cette valve interrompant la liaison entre les deux aiguilles creuses (2.4, 2.5) et ne se déplaçant en position ouverte uniquement lors de l'application d'une certaine force. Une zone dégagée (2.6) est aménagée sur le capuchon de transfert (2) pour insérer un instrument de perfusion.
EP20080802711 2007-10-01 2008-09-30 Dispositif pour introduire un médicament dans un flacon à perfusion Active EP2194951B1 (fr)

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 (fr) 2007-10-01 2008-09-30 Dispositif pour introduire un médicament dans un flacon à perfusion

Publications (2)

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

Family

ID=40091757

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20080802711 Active EP2194951B1 (fr) 2007-10-01 2008-09-30 Dispositif pour introduire un médicament dans un flacon à perfusion

Country Status (9)

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

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DE102007046951B3 (de) 2009-02-26
ES2464994T3 (es) 2014-06-04
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RU2010117377A (ru) 2011-11-10
CN101815496A (zh) 2010-08-25
RU2485930C2 (ru) 2013-06-27
US8647320B2 (en) 2014-02-11
WO2009046903A1 (fr) 2009-04-16
BRPI0817631B8 (pt) 2021-06-22
BRPI0817631B1 (pt) 2019-06-25
CN101815496B (zh) 2013-01-02
US20110004184A1 (en) 2011-01-06
EP2194951B1 (fr) 2014-02-26

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