EP2667838B1 - Verbindungsvorrichtung zum verbinden eines ersten reservoirs mit einem zweiten reservoir - Google Patents

Verbindungsvorrichtung zum verbinden eines ersten reservoirs mit einem zweiten reservoir Download PDF

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Publication number
EP2667838B1
EP2667838B1 EP20120703005 EP12703005A EP2667838B1 EP 2667838 B1 EP2667838 B1 EP 2667838B1 EP 20120703005 EP20120703005 EP 20120703005 EP 12703005 A EP12703005 A EP 12703005A EP 2667838 B1 EP2667838 B1 EP 2667838B1
Authority
EP
European Patent Office
Prior art keywords
piercing element
section
reservoir
piercing
connecting device
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.)
Not-in-force
Application number
EP20120703005
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2667838A1 (de
Inventor
Ismael Rahimy
Torsten Brandenburger
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland 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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP20120703005 priority Critical patent/EP2667838B1/de
Publication of EP2667838A1 publication Critical patent/EP2667838A1/de
Application granted granted Critical
Publication of EP2667838B1 publication Critical patent/EP2667838B1/de
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • A61J1/202—Separating means
    • A61J1/2031—Separating means having openings brought into alignment
    • 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
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/10—Coring prevention means, e.g. for plug or septum piecing members
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/9029—With coupling

Definitions

  • the invention relates to a connecting device for connecting a first reservoir to a second reservoir according to the preamble of claim 1.
  • connection devices referred to as "adapters” or “connectors”
  • a first reservoir which contains a medicinal substance
  • a second reservoir in which e.g. a liquid, connect, dilute the medicinal substance, dissolve and transfer to the second reservoir and e.g. to be able to mix with the liquid.
  • the medicinal substance in the first reservoir e.g. is formed in the form of a vial ("vial"), for example, a powder or a liquid.
  • the second reservoir is approximately in the form of a bag (for example in the form of an infusion bag) or a collapsible, flexible bottle.
  • this describes DE 199 30 791 A1 a needle adapter via which a first reservoir can be connected to a second reservoir.
  • the needle adapter has a hollow needle tapered at both ends, with which both a closure of the first reservoir and a closure of the second reservoir can be pierced and a flow connection between the two reservoirs can be established.
  • the provision of a flow connection also takes place by means of a hollow needle tapering at both ends.
  • hollow needles are used as a kind of actuator for opening and closing a separate valve body (see for example in US Pat WO 96/40327 A1 ).
  • such a separate valve body is provided by a membrane having openings.
  • US 4,373,559 A also describes a connection device.
  • the problem underlying the present invention is to provide a connection device which allows the most secure connection between a first and a second reservoir and the establishment of a flow connection between the reservoirs with the largest possible flow cross-section.
  • a re-closing of the flow connection is to be made possible.
  • the piercing member blocks flow communication between the first portion (or the first reservoir located at the first portion) and the second reservoir when disposed at the second portion, while in its second position, communicates flow between the first Section or the first reservoir and the second reservoir allows.
  • the piercing element does not constitute an actuator for opening and closing a separate valve body. Rather, the piercing element itself or components of the piercing element constitute a valve body which blocks or releases a flow connection or a passage opening.
  • the piercing element is arranged and configured such that, when the first reservoir is arranged on the first section, it is moved from the first to the second position, so that after the first reservoir has been arranged, a flow connection is established between the first and the second reservoir ( if the second reservoir is located at the second portion).
  • the piercing element with which the piercing element pierces the closure of the first reservoir when the first reservoir is arranged on the connecting device is designed as a tip.
  • the first and the second section are in particular sections of an (in particular one-piece) adapter part, wherein the piercing element is arranged to be movable relative to this adapter part.
  • the first section of the connecting device is in particular designed so that the first reservoir can be releasably fixed to the first section, eg as a receptacle for a type of medicament container (eg in the form of a glass or plastic bottle or a vial - "Vial").
  • a type of medicament container eg in the form of a glass or plastic bottle or a vial - "Vial"
  • shaped first reservoir wherein in the first section in particular a provided with the (eg in the form of a film or a stopper) provided neck of the medicament container can be used.
  • the first section indicates Connection structures (eg latching structures), via which the medicament container can be releasably fixed to the first section.
  • first and / or the second reservoir not directly, but at least one other element connected to the connection device and in particular can be fixed to this solvable, which will be discussed below.
  • the first reservoir When the first reservoir is arranged on the first portion of the connection device along an arrangement direction, e.g. Moves along the direction of arrangement in the first section, penetrates the piercing end of the piercing element, the closure of the first reservoir.
  • the piercing element is moved in the direction of arrangement with the first reservoir, i. pressed in the direction of the second portion of the connecting device and thus in the direction of the second reservoir, if the second reservoir is arranged on the second portion.
  • the piercing member when disposing the first reservoir, the piercing member is moved to the second position (open position) in which it allows flow communication between the two reservoirs.
  • the piercing element is moved to its second position upon placement of the first reservoir (e.g., only) due to the contact of the reservoir closure with the piercing element.
  • the piercing end penetrates the closure and the movement is generated due to the frictional force between a closure section bearing against the piercing element and the piercing element.
  • the piercing element does not penetrate the reservoir closure at first or only partially, but presses the reservoir closure against the piercing element when the first reservoir is arranged on the connecting device, and consequently the piercing element is moved in the direction of the second position.
  • the connection device has a stop which defines the second position of the piercing element, e.g. when arranging the first reservoir, the piercing element is pressed against the stop and only when a further movement of the first reservoir, the piercing of the piercing element then penetrates the closure.
  • the substance contained in the first reservoir (in particular in the form of a powder or a liquid) can thus be mixed (or dissolved) with the substance contained in the second reservoir (in particular in the form of a liquid). It is also conceivable that the second or the first reservoir is empty and only one transfer takes place from one to the other reservoir.
  • connection device allows the most secure and simple connection of two medical containers, in particular a medicine container (already mentioned above) with a medical bag (for example an infusion, transfusion or food bag). Since the flow connection to the second reservoir is not via a second tip of the piercing element, but in the manner of a valve by moving the piercing element into an open position, it is possible, on the side of the second portion of the connecting device has a larger flow cross-section and thus an overall larger flow between To realize the two reservoirs to allow the fastest possible mixing process.
  • the piercing member is moved to the second position when the first reservoir is positioned at the first portion by being inserted into a first position End position is brought relative to the first portion, wherein the piercing member is formed so that it is movable back into the first position when the first reservoir is moved away from the end position and from the second portion of the connecting device, for example, away from the first portion becomes.
  • the piercing element is thus taken along with an opposite movement of the first reservoir.
  • the flow connection between the first and the second portion of the connecting device closed again, thereby counteracting leakage of a substance located in the second reservoir after removal of the first reservoir or leakage of the substance is prevented as completely as possible.
  • the first reservoir does not necessarily have to be completely removed from the first portion of the connecting device. It is e.g. it is possible for the first reservoir to be moved from the end position to a ready position only, e.g. there is still some connection with the first section, but the piercing element has already been pulled into the blocking position, so that the flow connection between the first and the second reservoir is prevented.
  • the piercing member is movably disposed in a through opening of the connecting device relative to the first and / or second portion such that it is relative to the first and second when disposing the first reservoir (ie, when there is mechanical contact between the closure of the first reservoir and the piercing member) / or the second section is moved.
  • Possible embodiments of the passage opening will be explained below.
  • the piercing element forms a channel via which, in the second position of the piercing element, a flow connection between the first and the second portion of the connecting device, i. between the first and the second reservoir.
  • a flow connection between the first and the second portion of the connecting device, i. between the first and the second reservoir.
  • an edge portion of said through hole on the piercing member so as to block in the first position of the piercing member fluid communication between the first and the second portion via the channel of the piercing member.
  • the channel is designed in the form of a cavity extending in the interior of the piercing element, which extends from an inlet opening located in the region of its piercing end to at least one outlet opening.
  • the edge section of the passage opening blocks the passage between the outlet opening and the second section of the connecting device.
  • the piercing element can be designed in the form of a cannula, the inlet opening of which is formed in the end face of a pointed piercing end, so that the inlet opening is located in the interior thereof after piercing the closure of the first reservoir.
  • the voltage applied to an outer side of the piercing element edge portion of the passage opening does not have to cover the outlet opening directly in the blocking position of the piercing element.
  • the outlet opening of the piercing element can also be designed such that, in the blocking position (in the first position) of the piercing element, on a side of the piercing element facing the piercing end of the piercing element (ie the first reservoir) Adjacent edge portion of the through hole is located, ie the closest possible to the piercing edge portion of the passage opening does not cover the outlet immediately, but still prevents passage of the substance located in the first reservoir in the direction of a second portion of the connecting device arranged second reservoir.
  • the outlet opening is located on a side facing away from the piercing (ie the first reservoir) side of the piercing element abutting edge portion of the passage opening, so that a passage of a substance from the outlet opening of the piercing element in the second section and in the second reservoir is no longer blocked.
  • the piercing element is designed as an at least partially hollow body, for example as a tube.
  • the piercing element may be substantially hollow cylindrical, the outlet opening being e.g. essentially radially.
  • the outlet opening is introduced, for example, in the shell of a hollow body.
  • the outlet opening may extend in sections over the circumference of the piercing element, for example a hollow body.
  • the end of the piercing element which is at a distance from the piercing element is in particular designed to be closed, i. the piercing end facing away from the piercing element has no opening.
  • the piercing element has a plurality of preferably radial outlet openings.
  • the piercing element has an outlet opening and is movable from a first position to a second position, wherein in the first position, the outlet opening of the piercing element is closed and a flow connection between the first and the second section is blocked, while in the second position, the outlet opening of the piercing element is released or open and a flow connection between the first and the second portion is made possible.
  • the piercing member be in the form of a cannula, i. has a channel in the form of a cavity. Rather, it is also conceivable that the channel through which a substance from the first section (from the first reservoir) can enter the second reservoir, is formed as a depression in an outer side of the piercing element.
  • the puncturing element here can be a solid (in particular elongate) body which has on its outer side at least one groove extending along the longitudinal axis of the body, via which the substance can pass from the first into the second section of the connection device.
  • the blocking of such a channel in the first position of the piercing element is in particular realized in that an edge portion of the passage opening on a side facing the second portion of the connecting device side of the groove on the piercing element is tight and thus prevents a substance from the groove in the on second section arranged second reservoir passes.
  • the passage opening is delimited by an elastic material, at least in the region of its edge portion resting against the piercing element.
  • the elastic material is part of an elastic element arranged on or in the second section of the connecting device, which forms an opening which forms a partial region of the through-opening.
  • the Channel in the first position of the piercing element closed by the elastic element.
  • the outlet opening of the channel is closed or covered by the elastic element.
  • a partial section of the elastic element forms the edge section of the passage opening resting against the piercing element, wherein in the first position of the piercing element the outlet opening of the piercing element is covered by this section or the outlet opening is located on a side of the partial section of the elastic element facing the first section of the connecting device ,
  • the elastic element is in particular formed from a rubber-like material, in particular from polyisoprene, bromobutyl or chlorobutyl.
  • the piercing member is arranged and arranged to extend in the first position into or into the elastic member, i. E. it penetrates the elastic element not only in the second position (the open position), but already in the first position (the closed position). This will e.g. realized as small as possible adjustment between the closed and the open position. Furthermore, the force required to move the piercing element is kept as low as possible, since the elastic element does not have to be pierced when moving the piercing element into the second position.
  • the elastic element is formed in the manner of a membrane, through which the piercing element extends, so that the edge portion of the passage opening adjoining the piercing element is formed by a section of the elastic element which abuts the outside of the piercing element like a lip.
  • the piercing element has an opening in the form of a recess in the membrane material which extends through the piercing element.
  • the elastic element has a (eg central) opening, which has a slightly smaller diameter in comparison with the outer diameter of the piercing element before the passage of the piercing element, so that after passing through the piercing element, the edge region of this opening is bent and with a certain prestress on the piercing element Piercing element abuts.
  • the membrane initially has no opening, but the piercing element pierced through the membrane and thus only an opening in the membrane is generated.
  • the membrane is a self-sealing membrane, which would automatically close and seal again after removal of the piercing element.
  • the first portion of the connecting device is shaped in the form of a cup-shaped receptacle, i. the first section comprises a sidewall, e.g. extends substantially parallel to the possible direction of movement (or longitudinal direction) of the piercing element, as well as an obliquely or perpendicular to the side wall extending bottom region.
  • the bottom portion has an opening (e.g., central) forming a portion of the through-hole; i.e. the piercing member is movably passed through the bottom portion of the first portion.
  • the opening in the elastic member which may be in the form of a recess in the elastic member or produced by piercing the piercing member by the elastic member, forms a first portion of the through hole and the opening in the bottom of the first portion a second Subarea that aligns with the first subarea.
  • the passage opening is channel-like and penetrates both the bottom region of the first section and the elastic element, wherein the elastic element is arranged on one side wall of the first section (ie the first reservoir) facing away from the bottom region.
  • a guide (stabilization) of the piercing element can essentially take place via the opening in the bottom of the first section, while the elastic element mainly has a sealing function.
  • the bottom region has stabilizing structures, e.g.
  • the bottom has an area of greater thickness surrounding the opening through which the piercing member extends.
  • the piercing member has means for increasing a frictional force between an outer side of the piercing member and a portion of the closure of the first reservoir which abuts the outside of the piercing member after penetrating the piercing end of the piercing member.
  • the means for increasing the frictional force comprise friction-increasing structures in the outer side of the piercing element, for example in the form of a plurality of depressions and / or elevations of the outer side (in particular in the form of a roughening of the outer side).
  • the means for increasing the frictional force may comprise a friction-increasing coating arranged at least in sections on the outside of the piercing element.
  • the means for increasing the friction force depending on the material of the closure of the first reservoir are designed such that the frictional force occurring between the closure and the outside of the piercing element is greater than a frictional force between the mentioned elastic element and the outside of the piercing element.
  • the piercing element has at least one drain opening.
  • the drain opening is introduced in a jacket of a puncturing element formed at least in sections as a hollow body, preferably in a piercing element formed essentially as a hollow cylinder.
  • the drainage opening in the piercing element is arranged such that, in the second position of the piercing element, in which a flow connection between the first and the second section is made possible, it is located at least in sections in an interior of a reservoir arranged on the first section ,
  • arranging a drain port or a plurality of drain ports in the piercing member causes the remaining amount in a vial, which is positionable as a reservoir at the first section, to be kept small.
  • the piercing element may in particular be formed in one piece, for example of a plastic.
  • the piercing element may also, as described above, have a tip at its piercing end to facilitate penetration of the closure of the first reservoir. At its other end, however, it is in particular not pointed, wherein this end may have a larger outer diameter than the piercing.
  • the region of the larger outer diameter is located in the first position of the piercing element, for example in a through opening of the connecting device described above and there in particular in the region of an elastic element also described above, wherein by the abutment of the edge portion of the elastic member at the region of the larger outer diameter the best possible seal between the piercing element and the elastic element is achieved.
  • the piercing element has, in particular, an elongated, for example substantially cylindrical shape, wherein it is arranged to be movable along its longitudinal axis.
  • the invention is not limited to a particular geometry of the piercing element. Rather, the piercing element may, for example, also have a cylindrical, triangular, cross-shaped or star-shaped cross section.
  • the invention also relates to an arrangement comprising a connecting device as described above and a first reservoir arranged on the first section of the connecting device and / or a second reservoir arranged on the second section of the connecting device.
  • connecting device 1 has a first (upper) portion 11 for placing a (in Fig. 1A not shown) first reservoir in the form of a drug container and a second portion 12 for arranging a second reservoir (not shown) in the form of a bag, for example in the form of an infusion bag on.
  • the first and the second portion 11, 12 are integrally connected to each other, that is formed from a one-piece adapter part, which consists for example of a plastic such as polypropylene or polycarbonate.
  • a one-piece design of the first and second sections is not essential. It is also possible that the first and the second section are separate parts, which are connected to each other via connecting means.
  • the connecting device 1 also has an elongate piercing element in the form of a hollow needle 2.
  • the hollow needle 2 has a piercing in the form of a needle tip 21, with which the hollow needle 2 pierces a closure of the medicine container when it is inserted into the first portion 11 of the connecting device (see. Fig. 2A ).
  • the hollow needle 2 is arranged in a passage opening 3 of the connecting device, that they axially from a in Figure 1A shown first position to a second position ( FIG. 2A ) is movable.
  • the hollow needle 2 blocks a flow connection between the first portion 11 and the second portion 12, that is, the connecting device is closed.
  • liquid or another substance located in the second reservoir
  • the connecting device is closed.
  • the needle tip 21 presses against a closure 51 of the active substance container 5 or partially penetrates into the closure 51.
  • the hollow needle 2 is pushed toward the second portion 12 toward the second portion 12 when moving the drug container 5 to a second position, as in FIG Fig. 2A shown.
  • the second position of the hollow needle 2 is defined by a stop 63 of the second portion 12, wherein the hollow needle is pressed against the stop 63 via the movement of the active substance container 5.
  • the hollow needle 2 Upon further movement of the drug container 5, after the hollow needle has come to rest on the stop 63, the hollow needle 2 will completely penetrate the closure 51, so that a flow connection between the drug container and the hollow needle is produced.
  • the hollow needle already completely penetrates the closure 51 of the drug container before the hollow needle abuts against the stop 63, with movement of the hollow needle into the second position, in particular due to the friction between the outside of the hollow needle and the voltage applied to the outside of the hollow needle portion of the shutter 51 takes place.
  • the first portion 11 of the connecting device is cup-shaped, i. it has a side wall 111 and a bottom portion 112 which is oriented substantially perpendicular to the side wall.
  • the first section may have a docking position and an end position (activation position) (see above).
  • the floor area does not necessarily have to be flat, but may be e.g. also have a curvature.
  • the bottom region 112 there is a central opening 1121, which forms a partial region of the passage opening 3 and provides guidance of the hollow needle 2.
  • the bottom portion 112 has a thickening surrounding the opening 1121 in an annular manner.
  • the second section 12 of the connecting device 1 is configured substantially hollow-cylindrical, wherein in an intermediate region of the adapter part 100 between the first and the second section an elastic element in the form of a membrane 4 is arranged, e.g. clamped or materially connected to the adapter part 100 is connected.
  • the membrane 4 has a central opening 41 which is aligned with the opening 1121 of the first section 11 and which forms a second partial area of the through-opening 3.
  • a portion 42 of the membrane 4 the lip-like (from the rest of the membrane curved) tightly against an outer side of the hollow needle 2, thus forming an edge portion of the through hole 3 from.
  • the membrane seals the connection device.
  • the opening 41 in the membrane 4 may have been present as a recess in the membrane prior to the placement of the piercing element. However, it is also possible that the membrane was first formed continuously and the piercing element was pierced through the membrane.
  • the hollow needle 2 has a channel 22 formed as a cavity, which extends from an inlet 211 arranged in its tip 21 to two outlet openings 23 which are radially opposite one another in the region of the other, blunt end 212 of the hollow needle.
  • outlet openings 23 extend substantially radially, ie perpendicular to the longitudinal direction of the hollow needle 2.
  • outlet openings 23 are provided, for example, those extending predominantly along the main extension direction of the hollow needle 2.
  • the tip 212 facing away from the end 212 of the hollow needle 2 also has a slightly larger outer diameter than the region of the tip 21 and arranged in the opening 1121 of the first portion 11 portion of the hollow needle.
  • the edge portion 42 of the membrane 4 is located in the first position of the hollow needle 2 on the End portion 212 on, so that the outlet openings 23 above, ie on a tip 211 (or the first portion 11) facing side of the adjacent edge portion 42, are located, whereby a flow connection between the first and the second portion 11, 12 over the Cavity 21 of the hollow needle 2 and the outlet openings 22 is blocked.
  • outlet openings are located below the bottom 112 of the first section and thus in the blocking position of the hollow needle there is a certain flow connection between the first section and the area of the adapter part 100 between the bottom 112 and the adjacent edge section 42. Accordingly, this area does not belong to the "second section" 12 of the connecting device, which rather only begins below the position of the outlet openings (relative to the first position of the hollow needle), in particular below the membrane 4.
  • the hollow needle 2 moves when inserting the drug container 5 in the second position, the outlet openings 22 into the second section 12, ie they are then below (on a needle tip 21 opposite side) of the adjacent edge portion 42 of the membrane 4, so that about the outlet openings 22 a flow connection between the first and the second section 11, 12 consists.
  • the second reservoir that is, the medical bag, not shown, according to Figure 1A via another element in the form of a connecting piece 6, which is fixed to the second portion 12 of the connecting device 1, arranged on the second portion 12.
  • This connecting piece 6 has at its end facing away from the connecting device 1 wing-like arm 61 which inserted into an opening of the bag and the bag with the arms 61 or with an area above the boom connected (for example, welded or glued) can be.
  • the connecting piece 6 has connecting structures, for example latching structures, by way of which it is connected to the second section 12 of the connecting device 1.
  • the membrane 4 is clamped by the locking of the connecting piece 6 with the connecting device 1 so that the membrane 4 also realizes a seal between the connecting piece 6 and the connecting device.
  • the first portion 11 of the connection device also has structures by means of which the active substance container 5 can be releasably secured to the first portion or prevent at least an upward slippage (i.e., opposite to the insertion direction).
  • These structures comprise protrusions 110 which project inwardly from the inside of the side wall 111 and, after insertion of the active substance container, can engage behind an edge of its neck.
  • the active substance container 5 is pressed into the first section such that the edge of its neck is below the projections (end position). For example, the drug container is pushed in until the neck (or head) touches the bottom 112 of the first section.
  • protrusions 110 ' are also present on one edge of an opening 1111 of the first section 11, via which the active substance container 5 is inserted into the first section 11, wherein the active substance container 5 is in one Ready position can be arranged on the first portion 11, in which the container neck (in particular a projection 52 of the neck) between these projections 110 'and the projections 110 located further down is located.
  • the hollow needle 21 in the standby position the hollow needle 21 is not yet completely pushed into its second position, so that the flow connection to the second reservoir is still blocked. Only when the medicament container is pushed further down into the end position, the hollow needle is moved to the second position.
  • the projections 110 ' can also be used to bring the first reservoir after use (ie, from the second position) in the standby position, wherein by moving the first reservoir in the standby position, the piercing element is taken back to the first position, so that the Flow communication between the first and the second reservoir is interrupted.
  • the opening 1111 is closed with a closure in the form of a membrane or a film 7 in order to keep the connection device as sterile as possible.
  • the film 7 is removed.
  • the film 7 is e.g. a metal or plastic film (e.g., aluminum or polypropylene).
  • the longitudinal movement of the hollow needle 2 downwardly limiting stop 63 is provided by the connected to the second portion 12 connecting piece 6.
  • a stop is in particular integrally formed with the second portion 12 of the connecting device.
  • the hollow needle 21 returns to the blocking position when the drug container is moved far enough away from the second portion 12, e.g. removed from the first section 11 (i.e., completely disconnected from the connector) or brought to the ready position.
  • the hollow needle 2 has, in the region of the outlet openings 23, a conical portion widening away from its tip 211, which is designed so that withdrawal of the hollow needle 2 from the through-hole 3 beyond the first position is prevented.
  • the conical region of the hollow needle 2 in particular has a collar (cf. FIGS. 3A-D ), whose outer diameter is greater than the diameter of the opening 1121 of the bottom portion 112 of the first portion 11, so that the collar will come into abutment with the withdrawal of the hollow needle from the second position at the edge of the opening 1121.
  • the collar abuts the edge of the opening when the hollow needle is in its first position (the blocking position).
  • the hollow needle 2 may have on its outer side structures which increase a friction between an externally abutting portion of the closure 51 of the active substance container 5, so that the friction to the adjoining portion of the closure in the region of the friction-increased region is greater than outside friction increased area.
  • the friction-increased portion of the outside of the hollow needle 2 has a plurality of intersecting depressions 2100 or elevations. It is also conceivable that the outer side is additionally or alternatively merely roughened or provided with a coating which has a higher coefficient of friction compared to the outside of the hollow needle with respect to the material of the closure 51 of the container has.
  • the friction-increased area of the hollow needle outer side has a coefficient of friction which is greater than the coefficient of friction between the section of the hollow needle outside against which in the second position of the hollow needle the above-mentioned portion 42 of the elastic element, so that when moving the active substance container 5 from the End position ( Fig. 2A ) up the hollow needle 2 is taken up and brought back to its first position.
  • the friction-increasing structure or coating extends in particular only outside the region of the hollow needle 2, which is in its second position with the edge portion 42 of the elastic element 4 in contact.
  • the friction-enhancing structure or coating is only optional. It is also conceivable that the hollow needle is carried along without the presence of friction-increasing agent by moving the drug container from the first section to the first position.
  • FIGS. 3A to 3D show the hollow needle 21 from the Figures 1A and 2A again in detail. It can be seen in particular that the outlet openings 23 are arranged in a conical portion 210, which tapers towards the needle tip 21.
  • the conical portion 210 extends between a first hollow cylindrical portion 240 and a second hollow cylindrical portion 250, which forms the second end 212 of the hollow needle 21 and which has a larger outer diameter than the first hollow cylindrical portion 240.
  • the outlet openings 23 have an at least approximately rectangular cross-section in a section along a plane parallel to the longitudinal axis of the hollow needle.
  • the tip 21 opposite end 212 of the hollow needle 2 forms a closed end, so that in the second position of the hollow needle ( Fig. 2A ), the flow connection between the drug reservoir and the second reservoir only via the inlet opening 211, the cavity 22 and the outlet openings 23 consists.
  • FIGS. 4A to 4C each show a piercing element 2 with various embodiments of a drain opening 260.
  • a drain opening 260 represents a passage for the content, for example a liquid, of the first reservoir in the direction of the second reservoir or vice versa.
  • the drainage openings 260 are introduced into the jacket of the piercing element 2. They are positioned between the inlet opening 211 and the outlet opening 23. They can have different shapes and / or sizes.
  • FIG. 4A a drain opening 260 of elongate shape is shown extending along the longitudinal axis of the piercing member 2.
  • FIG. 4B also shows a drain opening 260 of elongate shape, but extending transversely to the longitudinal axis of the piercing element 2.
  • the length of a drain opening 260 may be on the order of 5 mm to 15 mm.
  • FIG. 4C shows a plurality of small, for example round, discharge openings 260.
  • FIGS. 5A and 5B show the FIGS. 5A and 5B the connecting device 1 without a connected reservoir 5 and the piercing element 2 in its first position, in which the channel, here the outlet opening 23 of the channel, is closed ( FIG. 5A ) and connected to the reservoir 5 and the piercing element 2 in its second position in which the channel, here the outlet opening 23 of the channel, open or is released ( FIG. 5B ).
  • the drainage openings 260 are introduced above the outlet opening 23 in the jacket of the piercing element 2.
  • the drainage openings 260 are displaced or arranged so far along the longitudinal axis of the piercing element 2 upwards, in the direction of the inlet opening 211, that they are in the inserted vial (as an example of a reservoir 5) and thus pierced piercing element 2, the interior of the vial assigned. They extend at least in sections, preferably completely, into the interior of the vial 5.
  • the residual quantity in the vial 5, which is located below the inlet opening 211 of the through-element 2 could not run out of the vial 5 without the outlet openings 260 and thus not be used , Through the drain openings 260, the residual amount in the connected vial 5 can be kept as low as possible.
  • the position of the drainage openings 260 in the piercing element 2 are selected such that the drainage openings 260 are at least in sections, preferably completely above the closure 51, in particular the seal of the closure 51.
  • the drain holes 260 are adjacent to the seal of the shutter 51.

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)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Transmission Of Braking Force In Braking Systems (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
EP20120703005 2011-01-25 2012-01-25 Verbindungsvorrichtung zum verbinden eines ersten reservoirs mit einem zweiten reservoir Not-in-force EP2667838B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20120703005 EP2667838B1 (de) 2011-01-25 2012-01-25 Verbindungsvorrichtung zum verbinden eines ersten reservoirs mit einem zweiten reservoir

Applications Claiming Priority (4)

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US201161435800P 2011-01-25 2011-01-25
EP11151942 2011-01-25
PCT/EP2012/051153 WO2012101178A1 (de) 2011-01-25 2012-01-25 Verbindungsvorrichtung zum verbinden eines ersten reservoirs mit einem zweiten reservoir
EP20120703005 EP2667838B1 (de) 2011-01-25 2012-01-25 Verbindungsvorrichtung zum verbinden eines ersten reservoirs mit einem zweiten reservoir

Publications (2)

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EP2667838A1 EP2667838A1 (de) 2013-12-04
EP2667838B1 true EP2667838B1 (de) 2014-12-31

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US (1) US8857470B2 (pt)
EP (1) EP2667838B1 (pt)
JP (1) JP2014506494A (pt)
CN (1) CN103402483B (pt)
AU (1) AU2012210586B2 (pt)
BR (1) BR112013018834A2 (pt)
CA (1) CA2825251A1 (pt)
CL (1) CL2013002120A1 (pt)
ES (1) ES2531146T3 (pt)
HK (1) HK1191847A1 (pt)
MX (1) MX2013008565A (pt)
WO (1) WO2012101178A1 (pt)
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BR112016024684B1 (pt) 2014-04-21 2022-06-28 Becton Dickinson and Company Limited Sistema para transferência fechada de fluidos e adapatdor de seringa
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ES2531146T3 (es) 2015-03-11
HK1191847A1 (en) 2014-08-08
CN103402483A (zh) 2013-11-20
WO2012101178A1 (de) 2012-08-02
US8857470B2 (en) 2014-10-14
JP2014506494A (ja) 2014-03-17
BR112013018834A2 (pt) 2017-01-31
ZA201305476B (en) 2014-10-29
WO2012101178A9 (de) 2012-11-01
US20120192976A1 (en) 2012-08-02
EP2667838A1 (de) 2013-12-04
AU2012210586B2 (en) 2016-03-17
CN103402483B (zh) 2015-11-25
CL2013002120A1 (es) 2014-04-04
MX2013008565A (es) 2013-08-21
CA2825251A1 (en) 2012-08-02

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