EP2667838B1 - Connecting device for connecting a first reservoir to a second reservoir - Google Patents

Connecting device for connecting a first reservoir to a second 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)
French (fr)
Other versions
EP2667838A1 (en
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/en
Publication of EP2667838A1 publication Critical patent/EP2667838A1/en
Application granted granted Critical
Publication of EP2667838B1 publication Critical patent/EP2667838B1/en
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)

Description

Die Erfindung betrifft eine Verbindungsvorrichtung zum Verbinden eines ersten Reservoirs mit einem zweiten Reservoir gemäß dem Oberbegriff des Anspruchs 1.The invention relates to a connecting device for connecting a first reservoir to a second reservoir according to the preamble of claim 1.

Aus der Medizintechnik sind Verbindungsvorrichtungen (als "adapter" oder "Konnektoren" bezeichnet) bekannt, mit denen sich ein erstes Reservoir, das eine medizinische Substanz enthält, mit einem zweiten Reservoir, in dem sich z.B. eine Flüssigkeit befindet, verbinden lässt, um die medizinische Substanz verdünnen, auflösen und in das zweite Reservoir überführen und z.B. mit der Flüssigkeit vermischen zu können. Die medizinische Substanz im ersten Reservoir, das z.B. in Form einer Phiole ("Vial") ausgeformt ist, ist beispielsweise ein Pulver oder eine Flüssigkeit. Das zweite Reservoir ist etwa in Form eines Beutels (zum Beispiel in Form eines Infusionsbeutels) oder einer kollabierbaren, flexiblen Flasche ausgebildet.From medical technology, connection devices (referred to as "adapters" or "connectors") are known, with which a first reservoir, which contains a medicinal substance, with 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.

Beispielsweise beschreibt die DE 199 30 791 A1 einen Nadeladapter, über den ein erstes Reservoir mit einem zweiten Reservoir verbunden werden kann. Der Nadeladapter weist eine an ihren beiden Enden spitz zulaufende Hohlnadel auf, mit der sowohl ein Verschluss des ersten Reservoirs als auch ein Verschluss des zweiten Reservoirs durchstochen und eine Strömungsverbindung zwischen den beiden Reservoiren hergestellt werden kann. In der US 6 022 339 A erfolgt das Bereitstellen einer Strömungsverbindung ebenso mittels einer an ihren beiden Enden spitz zulaufenden Hohlnadel. Ferner werden Hohlnadeln eingesetzt als eine Art Aktor zum Öffnen und Schließen eines separaten Ventilkörpers (siehe zum Beispiel in der WO 96/40327 A1 ). In der EP 0 795 651 A1 wird ein solcher separater Ventilkörper zum Beispiel durch eine Membran mit Öffnungen bereitgestellt. US 4 373 559 A beschreibt ebenso eine Verbindungsvorrichtung.For example, 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. In the US 6 022 339 A the provision of a flow connection also takes place by means of a hollow needle tapering at both ends. Furthermore, 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 ). In the EP 0 795 651 A1 For example, such a separate valve body is provided by a membrane having openings. US 4,373,559 A also describes a connection device.

Das der vorliegenden Erfindung zugrunde liegende Problem besteht darin, eine Verbindungsvorrichtung zu schaffen, die eine möglichst sichere Verbindung zwischen einem ersten und einem zweiten Reservoir und das Herstellen einer Strömungsverbindung zwischen den Reservoiren mit einem möglichst großen Strömungsquerschnitt ermöglicht. Insbesondere soll auch ein Wiederverschließen der Strömungsverbindung ermöglicht werden.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. In particular, a re-closing of the flow connection is to be made possible.

Dieses Problem wird durch die Verbindungsvorrichtung mit den kennzeichnenden Merkmalen gemäß Anspruch 1 gelöst. Weiterbildungen der Erfindung sind in abhängigen Ansprüchen angegeben.This problem is solved by the connecting device having the characterizing features according to claim 1. Further developments of the invention are specified in the dependent claims.

Demnach wird eine Verbindungsvorrichtung zum Verbinden eines ersten mit einem zweiten Reservoir bereitgestellt, mit

  • einem ersten Abschnitt zum Anordnen, insbesondere Verbinden, des ersten, mit einem Verschluss verschlossenen Reservoirs;
  • einem zweiten Abschnitt zum Anordnen, insbesondere Verbinden, des zweiten Reservoirs; und
  • einem Durchstechelement, das bei einem Anordnen des ersten Reservoirs an dem ersten Abschnitt mit einem Durchstechende den Verschluss des ersten Reservoirs durchsticht, wobei
  • das Durchstechelement einen Kanal aufweist und (relativ zu dem ersten und dem zweiten Abschnitt) aus einer ersten Position in eine zweite Position bewegbar ist, wobei
  • in der ersten Position der Kanal des Durchstechelements verschlossen oder geschlossen ist und eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt blockiert ist, während
  • in der zweiten Position der Kanal des Durchstechelements freigegeben oder offen ist und eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt ermöglicht ist.
Accordingly, a connecting device is provided for connecting a first to a second reservoir, with
  • a first portion for arranging, in particular connecting, the first reservoir closed with a closure;
  • a second section for arranging, in particular connecting, the second reservoir; and
  • a piercing member piercing the closure of the first reservoir when disposing the first reservoir at the first portion with a piercing end, wherein
  • the piercing member has a channel and is movable (relative to the first and second portions) from a first position to a second position, wherein
  • in the first position, the channel of the piercing member is closed or closed, and flow communication between the first and second portions is blocked while
  • in the second position, the channel of the piercing element is released or opened and a flow connection between the first and the second section is made possible.

Weiterhin wird die Erfindung auch beschrieben durch eine Verbindungsvorrichtung zum Verbinden eines ersten mit einem zweiten Reservoir mit

  • einem ersten Abschnitt zum Anordnen des ersten, mit einem Verschluss verschlossenen Reservoirs;
  • einem zweiten Abschnitt zum Anordnen (insbesondere Verbinden) des zweiten Reservoirs; und
  • einem Durchstechelement, das bei einem Anordnen (insbesondere Verbinden) des ersten Reservoirs an dem ersten Abschnitt mit einem Durchstechende den Verschluss des ersten Reservoirs durchsticht, wobei
  • das Durchstechelement (relativ zu dem ersten und dem zweiten Abschnitt) aus einer ersten Position in eine zweite Position bewegbar ist, wobei es in der ersten Position eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt blockiert, während es in der zweiten Position eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt ermöglicht.
Furthermore, the invention is also described by a connecting device for connecting a first to a second reservoir
  • a first portion for disposing the first reservoir closed with a closure;
  • a second section for arranging (in particular connecting) the second reservoir; and
  • a puncture member piercing the closure of the first reservoir when arranging (in particular connecting) the first reservoir to the first portion with a piercing end, wherein
  • the piercing member (relative to the first and second portions) is movable from a first position to a second position, blocking flow communication between the first and second portions in the first position, and communicating fluidly between the first and second portions in the second position first and second section allows.

Insbesondere blockiert das Durchstechelement in der ersten Position eine Strömungsverbindung zwischen dem ersten Abschnitt (oder dem an dem ersten Abschnitt angeordneten ersten Reservoir) und dem zweiten Reservoir, wenn dieses an dem zweiten Abschnitt angeordnet ist, während es in seiner zweiten Position eine Strömungsverbindung zwischen dem ersten Abschnitt oder dem ersten Reservoir und dem zweiten Reservoir ermöglicht. Das Durchstechelement stellt keinen Aktor zum Öffnen und Schließen eines separaten Ventilkörpers dar. Vielmehr stellt das Durchstechelement selbst oder Bestandteile des Durchstechelements stellen einen Ventilkörper dar, welcher eine Strömungsverbindung oder eine Durchgangsöffnung blockiert oder freigibt.In particular, in the first position, 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.

Beispielsweise ist das Durchstechelement so angeordnet und ausgebildet, dass es bei einem Anordnen des ersten Reservoirs an dem ersten Abschnitt aus der ersten in die zweite Position bewegt wird, so dass nach Anordnen des ersten Reservoirs eine Strömungsverbindung zwischen dem ersten und dem zweiten Reservoir hergestellt wird (falls das zweite Reservoir an dem zweiten Abschnitt angeordnet ist).For example, 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).

Insbesondere ist das Durchstechende, mit dem das Durchstechelement beim Anordnen des ersten Reservoirs an der Verbindungsvorrichtung den Verschluss des ersten Reservoirs durchsticht, als Spitze ausgebildet. Der erste und der zweite Abschnitt sind insbesondere Abschnitte eines (insbesondere einstückigen) Adapterteils, wobei das Durchstechelement relativ zu diesem Adapaterteil bewegbar angeordnet ist.In particular, 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.

Der erste Abschnitt der Verbindungsvorrichtung ist insbesondere so ausgebildet, dass das erste Reservoir an dem ersten Abschnitt lösbar festgelegt werden kann, z.B. als Aufnahme für ein nach Art eines Medikamentenbehälter (z.B. in Form einer Glas- oder Kunststoffflasche bzw. einer Phiole - "Vial") ausgeformtes erstes Reservoir, wobei in den ersten Abschnitt insbesondere ein mit dem (z.B. in Form einer Folie oder eines Stopfens ausgebildeten) Verschluss versehener Hals des Medikamentenbehälters eingesetzt werden kann. Beispielsweise weist der erste Abschnitt Verbindungsstrukturen (z.B. Raststrukturen) auf, über die der Medikamentenbehälter an dem ersten Abschnitt lösbar festgelegt werden kann.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"). 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. For example, the first section indicates Connection structures (eg latching structures), via which the medicament container can be releasably fixed to the first section.

Es wird darauf hingewiesen, dass es durchaus möglich ist, dass das erste und/oder das zweite Reservoir nicht unmittelbar, sondern über mindestes ein weiteres Element mit der Verbindungsvorrichtung verbunden und insbesondere an dieser lösbar festgelegt werden kann, worauf weiter unten noch eingegangen werden wird.It should be noted that it is quite possible that the 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.

Wird das erste Reservoirs an dem ersten Abschnitt der Verbindungsvorrichtung entlang einer Anordnungsrichtung angeordnet, z.B. entlang der Anordnungsrichtung in den ersten Abschnitt hineinbewegt, durchdringt das Durchstechende des Durchstechelementes den Verschluss des ersten Reservoirs. Darüber hinaus wird über den mechanischen Kontakt des Verschlusses mit dem Durchstechelement das Durchstechelement in Anordnungsrichtung mit dem ersten Reservoir mitbewegt, d.h. in Richtung des zweiten Abschnitts der Verbindungsvorrichtung und somit in Richtung des zweiten Reservoirs gedrückt, falls das zweite Reservoir an dem zweiten Abschnitt angeordnet ist.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. In addition, via the mechanical contact of the closure with the piercing element, 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.

Somit wird beim Anordnen des ersten Reservoirs das Durchstechelement in die zweite Position (Öffnungsstellung) bewegt, in der es eine Strömungsverbindung zwischen den beiden Reservoiren ermöglicht. Insbesondere wird das Durchstechelement beim Anordnen des ersten Reservoirs (z.B. ausschließlich) aufgrund des Kontaktes des Reservoirverschlusses mit dem Durchstechelement in seine zweite Position bewegt. Hierbei ist denkbar, dass beim Anordnen des ersten Reservoirs an der Verbindungsvorrichtung das Durchstechende den Verschluss durchdringt und aufgrund der Reibungskraft zwischen einem an dem Durchstechelement anliegenden Verschlussabschnitt und dem Durchstechelement die Bewegung erzeugt wird.Thus, 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. In particular, 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. In this case, it is conceivable that when the first reservoir is arranged on the connecting device, 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.

Es ist jedoch auch möglich, dass das Durchstechelement den Reservoirverschluss zunächst nicht oder nur teilweise durchdringt, sondern beim Anordnen des ersten Reservoirs an der Verbindungsvorrichtung der Reservoirverschluss gegen das Durchstechelement drückt und das infolgedessen das Durchstechelement in Richtung auf die zweite Position bewegt wird. Insbesondere weist die Verbindungsvorrichtung einen Anschlag auf, der die zweite Position des Durchstechelements definiert, wobei z.B. beim Anordnen des ersten Reservoirs das Durchstechelement gegen den Anschlag gedrückt wird und erst bei einem Weiterbewegen des ersten Reservoirs das Durchstechende des Durchstechelementes dann den Verschluss durchdringt.However, it is also possible that 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. In particular, 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.

Nach dem Anordnen des ersten Reservoirs an der Verbindungsvorrichtung lässt sich somit die in dem ersten Reservoir enthaltene Substanz (insbesondere in Form eines Pulvers oder einer Flüssigkeit) mit der im zweiten Reservoir enthaltenen Substanz (insbesondere in Form einer Flüssigkeit) vermischen (bzw. auflösen). Auch ist denkbar, dass das zweite oder das erste Reservoir leer ist und lediglich ein Umfüllen aus dem einen in das andere Reservoir erfolgt.After arranging the first reservoir on the connecting device, 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.

Die erfindungsgemäße Verbindungsvorrichtung erlaubt insbesondere ein möglichst sicheres und einfaches Verbinden zweier medizinischer Behälter, insbesondere eines (oben bereits erwähnten) Medizinbehälters mit einem medizinischen Beutel (z.B. einem Infusions-, Transfusions-, oder Nahrungsmittelbeutels). Da die Strömungsverbindung zu dem zweiten Reservoir nicht über eine zweite Spitze des Durchstechelementes, sondern nach Art eines Ventils durch Bewegen des Durchstechelements in eine Öffnungsstellung erfolgt, ist es möglich, auf Seiten des zweiten Abschnitts der Verbindungsvorrichtung einen größeren Strömungsquerschnitt und somit einen insgesamt größeren Fluss zwischen den beiden Reservoiren zu realisieren, um einen möglichst schnellen Mischvorgang zu ermöglichen.In particular, the connection device according to the invention 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.

Das Durchstechelement wird insbesondere in die zweite Position bewegt, wenn das erste Reservoir dadurch an dem ersten Abschnitt angeordnet wird, dass es in eine Endstellung relativ zu dem ersten Abschnitt gebracht wird, wobei das Durchstechelement so ausgebildet ist, dass es zurück in die erste Position bewegbar ist, wenn das erste Reservoir aus der Endstellung und von dem zweiten Abschnitt der Verbindungsvorrichtung weg bewegt wird, z.B. von dem ersten Abschnitt entfernt wird.In particular, 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.

Das Durchstechelement wird also bei einer entgegengesetzten Bewegung des ersten Reservoirs mitgenommen. Infolgedessen wird z.B. bei einem Entfernen des ersten Reservoirs die Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt der Verbindungsvorrichtung wieder verschlossen, wodurch einem Austreten einer in dem zweiten Reservoir befindlichen Substanz nach dem Entfernen des ersten Reservoirs entgegengewirkt oder ein Austreten der Substanz möglichst ganz verhindert wird. Um das Durchstechelement in seine erste Position (die Sperrposition) zurück zu bringen, muss das erste Reservoir jedoch nicht unbedingt vollständig von dem ersten Abschnitt der Verbindungsvorrichtung entfernt werden. Es ist z.B. möglich, dass das erste Reservoir aus der Endstellung lediglich in eine Bereitschaftsstellung bewegt wird, in z.B. noch eine gewisse Verbindung mit dem ersten Abschnitt besteht, das Durchstechelement jedoch bereits in die Sperrposition gezogen wurde, so dass die Strömungsverbindung zwischen dem ersten und dem zweiten Reservoir unterbunden ist.The piercing element is thus taken along with an opposite movement of the first reservoir. As a result, e.g. upon removal 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. However, in order to return the piercing member to its first position (the blocking position), 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.

Das Durchstechelement ist in einer Durchgangsöffnung der Verbindungsvorrichtung relativ zu dem ersten und/oder zweiten Abschnitt bewegbar angeordnet, so dass es beim Anordnen des ersten Reservoirs (d.h. wenn ein mechanischer Kontakt zwischen dem Verschluss des ersten Reservoirs und dem Durchstechelement besteht) relativ zu dem ersten und/oder dem zweiten Abschnitt bewegt wird. Mögliche Ausgestaltungen der Durchgangsöffnung werden weiter unten erläutert.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.

Gemäß einer anderen Variante der Erfindung bildet das Durchstechelement einen Kanal aus, über den in der zweiten Position des Durchstechelements eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt der Verbindungsvorrichtung, d.h. zwischen dem ersten und dem zweiten Reservoir, besteht. Hier liegt z.B. ein Randabschnitt der erwähnten Durchgangsöffnung an dem Durchstechelement so an, dass er in der ersten Position des Durchstechelements eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt über den Kanal des Durchstechelements sperrt.According to another variant of the invention, 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. Here is e.g. 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.

Beispielsweise ist der Kanal in Form eines sich im Inneren des Durchstechelementes erstreckenden Hohlraums ausgebildet, der von einer im Bereich seines Durchstechendes befindlichen Eintrittsöffnung bis zu mindestens einer Austrittsöffnung verläuft. In der ersten Position des Durchstechelements sperrt der Randabschnitt der Durchgangsöffnung die Passage zwischen der Austrittsöffnung und dem zweiten Abschnitt der Verbindungsvorrichtung. Das Durchstechelement kann in Form einer Kanüle ausgebildet sein, deren Eintrittsöffnung in der Stirnseite eines spitzen Durchstechendes ausgebildet ist, so dass sich die Eintrittsöffnung nach Durchstechen des Verschlusses des ersten Reservoirs in dessen Innern befindet. Somit kann, falls sich das Durchstechelement in seiner Öffnungsstellung befindet, die im ersten Reservoir befindliche Substanz über die Eintrittsöffnung in den Hohlraum des Durchstechelementes und schließlich über dessen Austrittsöffnung in den zweiten Abschnitt der Verbindungsvorrichtung und in das zweite Reservoir gelangen.For example, 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. In the first position of the piercing element, 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. Thus, if the piercing element is in its open position, the substance located in the first reservoir can reach the cavity of the piercing element via the inlet opening and finally into the second section of the connecting device and into the second reservoir via its outlet opening.

Der an einer Außenseite des Durchstechelementes anliegende Randabschnitt der Durchgangsöffnung muss in Sperrstellung des Durchstechelementes die Austrittsöffnung nicht unmittelbar überdecken. Vielmehr kann die Austrittsöffnung des Durchstechelementes auch so ausgebildet sein, dass sie sich in Sperrstellung (in der ersten Position) des Durchstechelementes auf einer dem Durchstechende des Durchstechelementes (d.h. dem ersten Reservoir) zugewandten Seite des anliegenden Randabschnitts der Durchgangsöffnung befindet, d.h. der am Durchstechelement möglichst dicht anliegende Randabschnitt der Durchgangsöffnung deckt die Austrittsöffnung nicht unmittelbar ab, verhindert jedoch dennoch ein Durchtreten der im ersten Reservoir befindlichen Substanz in Richtung eines am zweiten Abschnitts der Verbindungsvorrichtung angeordneten zweiten Reservoirs.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. Rather, 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.

In der zweiten Position des Durchstechelementes befindet sich die Austrittsöffnung auf einer dem Durchstechende (d.h. dem ersten Reservoir) abgewandten Seite des am Durchstechelement anliegenden Randabschnitts der Durchgangsöffnung, so dass ein Durchtreten einer Substanz aus der Austrittsöffnung der Durchstechelements in den zweiten Abschnitt und in das zweite Reservoir nicht mehr blockiert wird.In the second position of the piercing element, 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.

In einer Ausführungsform der Erfindung ist das Durchstechelement als ein zumindest abschnittsweise hohler Körper, beispielsweise als ein Rohr, ausgebildet. Das Durchstechelement kann im Wesentlichen hohlzylindrisch ausgebildet sein, wobei die Austrittsöffnung z.B. im Wesentlichen radial verläuft. Die Austrittsöffnung ist zum Beispiel in dem Mantel eines Hohlkörpers eingebracht. Die Austrittsöffnung kann sich abschnittsweise über den Umfang des Durchstechelements, beispielsweise eines Hohlkörpers, erstrecken. Das von dem Durchstechende beabstandete Ende des Durchstechelementes ist insbesondere geschlossen ausgebildet, d.h. die dem Durchstechende abgewandte Stirnseite des Durchstechelementes weist keine Öffnung auf. Insbesondere weist das Durchstechelement mehrere vorzugsweise radiale Austrittsöffnungen auf. Es sind jedoch selbstverständlich auch anders gestaltete Austrittöffnungen denkbar, wie weiter unten erläutert.In one embodiment of the invention, 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. In particular, the piercing element has a plurality of preferably radial outlet openings. However, it is of course also differently shaped outlet openings conceivable, as explained below.

Die Erfindung kann in dieser Ausgestaltung auch dadurch beschrieben werden, dass das Durchstechelement eine Ausgangsöffnung aufweist und aus einer ersten Position in eine zweite Position bewegbar ist, wobei in der ersten Position die Ausgangsöffnung des Durchstechelements verschlossen ist und eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt blockiert ist, während in der zweiten Position die Ausgangsöffnung des Durchstechelements freigegeben oder offen ist und eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt ermöglicht wird.The invention can also be described in this embodiment in that 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.

Es wird darauf hingewiesen, dass es nicht zwingend erforderlich ist, dass das Durchstechelement in Form einer Kanüle ausgebildet ist, d.h. einen Kanal in Form eines Hohlraums aufweist. Vielmehr ist auch denkbar, dass der Kanal, über den eine Substanz aus dem ersten Abschnitt (aus dem ersten Reservoir) in das zweite Reservoir gelangen kann, als Vertiefung in einer Außenseite des Durchstechelementes ausgeformt ist. Insbesondere kann es sich hier bei dem Durchstechelement um einen massiven (insbesondere länglichen) Körper handeln, der an seiner Außenseite mindestens eine sich entlang der Längsachse des Körpers erstreckende Nut aufweist, über die die Substanz aus dem ersten in den zweiten Abschnitt der Verbindungsvorrichtung gelangen kann.It should be understood that it is not mandatory that 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. In particular, 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.

Das Blockieren eines derartigen Kanals in der ersten Position des Durchstechelementes wird insbesondere dadurch realisiert, dass ein Randabschnitt der Durchgangsöffnung auf einer dem zweiten Abschnitt der Verbindungsvorrichtung zugewandten Seite der Nut an dem Durchstechelement dicht anliegt und somit verhindert, dass eine Substanz aus der Nut in das am zweiten Abschnitt angeordnete zweite Reservoir gelangt.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.

Gemäß einer anderen Ausgestaltung der Erfindung ist die Durchgangsöffnung zumindest in dem Bereich ihres an dem Durchstechelement anliegenden Randabschnitts durch ein elastisches Material begrenzt. Beispielsweise ist das elastische Material Bestandteil eines am oder im zweiten Abschnitt der Verbindungsvorrichtung angeordneten elastischen Elementes, das eine Öffnung ausbildet, die einen Teilbereich der Durchgangsöffnung darstellt. Insbesondere ist der Kanal in der ersten Position des Durchstechelements durch das elastische Element verschlossen. In der Ausgestaltung des Durchstechelements als ein zumindest abschnittsweiser hohler Körper oder ein Rohr ist die Austrittsöffnung des Kanals durch das elastische Element verschlossen oder abgedeckt.According to another embodiment of the invention, the passage opening is delimited by an elastic material, at least in the region of its edge portion resting against the piercing element. For example, 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. In particular, the Channel in the first position of the piercing element closed by the elastic element. In the embodiment of the piercing element as an at least partially hollow body or a tube, the outlet opening of the channel is closed or covered by the elastic element.

Insbesondere bildet ein Teilabschnitt des elastischen Elementes den am Durchstechelement anliegenden Randabschnitt der Durchgangsöffnung, wobei in der ersten Position des Durchstechelementes die Austrittsöffnung des Durchstechelementes durch diesen Teilabschnitt abgedeckt wird oder sich die Austrittsöffnung auf einer dem ersten Abschnitt der Verbindungsvorrichtung zugewandten Seite des Teilabschnitts des elastischen Elementes befindet. Das elastische Element ist insbesondere aus einem gummiartigen Material gebildet, insbesondere aus Polyisopren, Brombutyl oder Chlorbutyl.In particular, 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.

Es ist möglich, dass das Durchstechelement so angeordnet und beschaffen ist, dass es sich in der ersten Position in das elastische Element hinein oder durch das elastische Element hindurch erstreckt, d.h. es durchdringt das elastische Element nicht erst in der zweiten Position (der geöffneten Stellung), sondern bereits in der ersten Position (der geschlossenen Stellung). Dadurch wird z.B. ein möglichst geringer Verstellweg zwischen der geschlossenen und der geöffneten Stellung realisiert. Des Weiteren wird die Kraft, die zum Bewegen des Durchstechelementes erforderlich ist, möglichst gering gehalten, da das elastische Element bei Bewegen des Durchstechelementes in die zweite Position nicht erst durchstochen werden muss.It is possible that 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.

Insbesondere ist das elastische Element nach Art einer Membran ausgeformt, durch die sich das Durchstechelement hindurch erstreckt, so dass der am Durchstechelement anliegende Randabschnitt der Durchgangsöffnung durch einen Teilabschnitt des elastischen Elements gebildet wird, der lippenartig an der Außenseite des Durchstechelementes anliegt. Das Durchstechelement weist insbesondere eine Öffnung in Form einer Aussparung in dem Membranmaterial die auf, durch sich das Durchstechelement hindurch erstreckt. Beispielsweise weist das elastische Element eine (z.B. mittige) Öffnung auf, die vor dem Hindurchführen des Durchstechelementes im Vergleich mit dem Außendurchmesser des Durchstechelementes einen etwas kleineren Durchmesser besitzt, so dass nach Hindurchführen des Durchstechelementes der Randbereich dieser Öffnung abgebogen und mit einer gewissen Vorspannung an dem Durchstechelement anliegt.In particular, 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. In particular, the piercing element has an opening in the form of a recess in the membrane material which extends through the piercing element. For example, 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.

Es ist allerdings auch möglich, dass die Membran zunächst keine Öffnung aufweist, sondern das Durchstechelement durch die Membran durchgestochen und dadurch erst eine Öffnung in der Membran erzeugt wird. Beispielsweise ist die Membran eine selbstabdichtende Membran, die sich nach Entfernen des Durchstechelementes selbständig wieder verschließen und abdichten würde.However, it is also possible that the membrane initially has no opening, but the piercing element pierced through the membrane and thus only an opening in the membrane is generated. For example, the membrane is a self-sealing membrane, which would automatically close and seal again after removal of the piercing element.

Gemäß einer weiteren Erfindungsvariante ist der erste Abschnitt der Verbindungsvorrichtung in Form einer becherartigen Aufnahme ausgeformt, d.h. der erste Abschnitt umfasst eine Seitenwand, die z.B. im Wesentlichen parallel zu der möglichen Bewegungsrichtung (oder Längserstreckungsrichtung) des Durchstechelementes verläuft, sowie einen schräg oder senkrecht zu der Seitenwand verlaufenden Bodenbereich. Der Bodenbereich weist insbesondere eine (z.B. zentrale) Öffnung auf, die einen Teilbereich der Durchgangsöffnung ausbildet; d.h. das Durchstechelement ist bewegbar durch den Bodenbereich des ersten Abschnitts hindurchgeführt.According to a further variant of the invention, 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. In particular, 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.

Insbesondere bildet die Öffnung in dem elastischen Element, die in Form einer Aussparung in dem elastischen Element vorhanden oder durch Hindurchstechen des Durchstechelementes durch das elastische Element erzeugt worden sein kann, einen ersten Teilbereich der Durchgangsöffnung aus und die Öffnung in dem Boden des ersten Abschnitts einen zweiten Teilbereich, der mit dem ersten Teilbereich fluchtet. Mit anderen Worten ist die Durchgangsöffnung kanalartig ausgebildet und durchsetzt sowohl den Bodenbereich des ersten Abschnitts als auch das elastische Element, wobei das elastische Element auf einer der Seitenwand des ersten Abschnitts (d.h. dem ersten Reservoir) abgewandten Seite des Bodenbereichs angeordnet ist.In particular, 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. In other words, 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.

Es wird darauf hingewiesen, dass eine Führung (Stabilisierung) des Durchstechelementes im Wesentlichen über die Öffnung in dem Boden des ersten Abschnitts erfolgen kann, während dem elastischen Element hauptsächlich eine Dichtfunktion zukommt. Insbesondere weist der Bodenbereich stabilisierende Strukturen auf, z.B. weist der Boden einen die Öffnung, durch die sich das Durchstechelement hindurch erstreckt, umgebenden Bereich größerer Dicke auf.It should be noted that 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. In particular, the bottom region has stabilizing structures, e.g. For example, the bottom has an area of greater thickness surrounding the opening through which the piercing member extends.

Gemäß einer anderen Ausführungsform der Erfindung weist das Durchstechelement Mittel zum Erhöhen einer Reibungskraft zwischen einer Außenseite des Durchstechelementes und einem Abschnitt des Verschlusses des ersten Reservoirs, der nach Durchdringen des Durchstechendes des Durchstechelementes an der Außenseite des Durchstechelementes anliegt, auf. Beispielsweise umfassen die Mittel zum Erhöhen der Reibungskraft reibungserhöhende Strukturen in der Außenseite des Durchstechelementes zum Beispiel in Form einer Mehrzahl von Vertiefungen und/oder Erhöhungen der Außenseite (insbesondere in Form einer Aufrauung der Außenseite).According to another embodiment of the invention, 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. For example, 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).

Des Weiteren ist es möglich, dass die Mittel zum Erhöhen der Reibungskraft eine zumindest abschnittsweise an der Außenseite des Durchstechelementes angeordnete reibungserhöhende Beschichtung umfassen. Beispielsweise sind die Mittel zur Erhöhung der Reibungskraft in Abhängigkeit von dem Material des Verschlusses des ersten Reservoirs so ausgelegt, dass die zwischen dem Verschluss und der Außenseite des Durchstechelementes auftretende Reibungskraft größer ist als eine Reibungskraft zwischen dem erwähnten elastischen Element und der Außenseite des Durchstechelements. Somit ist sichergestellt, dass das Durchstechelement bei einem Entfernen des ersten Reservoirs aus dem ersten Abschnitt der Verbindungsvorrichtung in seine erste Position zurückgeholt und das zweite Reservoir verschlossen wird.Furthermore, it is possible for the means for increasing the frictional force to comprise a friction-increasing coating arranged at least in sections on the outside of the piercing element. For example, 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. Thus, it is ensured that the piercing element is retrieved when removing the first reservoir from the first portion of the connecting device in its first position and the second reservoir is closed.

In einer weiteren Ausführungsform der Erfindung weist das Durchstechelement wenigstens eine Ablauföffnung auf. Insbesondere ist die Ablauföffnung in einem Mantel eines zumindest abschnittsweise als Hohlkörper ausgebildeten Durchstechelements, vorzugsweise in einem im Wesentlichen hohlzylindrisch ausgebildeten Durchstechelement, eingebracht. In einer Ausgestaltung ist die Ablauföffnung in dem Durchstechelement so angeordnet ist, dass sie sich in der zweiten Position des Durchstechelements, in der eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt ermöglicht ist, zumindest abschnittsweise in einem Innenraum eines an dem ersten Abschnitt angeordneten Reservoirs befindet. Die Anordnung einer Ablauföffnung oder einer Vielzahl an Ablauföffnungen in dem Durchstechelement bewirkt zum Beispiel, dass die Restmenge in einem Vial, welches als Reservoir an dem ersten Abschnitt positionierbar ist, gering gehalten werden kann.In a further embodiment of the invention, the piercing element has at least one drain opening. In particular, 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. In one embodiment, 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 , For example, 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.

Das Durchstechelement kann insbesondere einstückig ausgebildet sein, zum Beispiel aus einem Kunststoff. Das Durchstechelement kann zudem, wie oben beschrieben, an seinem Durchstechende eine Spitze aufweisen, um ein Durchdringen des Verschlusses des ersten Reservoirs zu erleichtern. An seinem anderen Ende ist es hingegen insbesondere nicht spitz ausgebildet, wobei dieses Ende einen größeren Außendurchmesser als das Durchstechende aufweisen kann. Der Bereich des größeren Außendurchmessers befindet sich in der ersten Position des Durchstechelementes z.B. in einer oben beschriebenen Durchgangsöffnung der Verbindungsvorrichtung und dort insbesondere im Bereich eines ebenfalls oben beschriebenen elastischen Elementes, wobei durch das Anliegen des Randabschnitts des elastischen Elementes an dem Bereich des größeren Außendurchmessers eine möglichst gute Abdichtung zwischen dem Durchstechelement und dem elastischen Element erzielt wird.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.

Das Durchstechelement weist, wie oben bereits erwähnt, insbesondere eine längserstreckte, zum Beispiel im Wesentlichen zylindrische Form auf, wobei es entlang seiner Längsachse bewegbar angeordnet ist. Die Erfindung ist jedoch selbstverständlich nicht auf eine bestimmte Geometrie des Durchstechelementes festgelegt. Vielmehr kann das Durchstechelement zum Beispiel auch einen zylindrischen, dreieckigen, kreuz- oder sternförmigen Querschnitt aufweisen.As already mentioned above, the piercing element has, in particular, an elongated, for example substantially cylindrical shape, wherein it is arranged to be movable along its longitudinal axis. Of course, 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.

Die Erfindung betrifft auch eine Anordnung aus einer wie oben beschriebenen Verbindungsvorrichtung sowie einem an dem ersten Abschnitt der Verbindungsvorrichtung angeordneten ersten Reservoir und/oder einem an dem zweiten Abschnitt der Verbindungsvorrichtung angeordneten zweiten Reservoir.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.

Die Erfindung wird im Folgenden anhand von Ausführungsbeispielen in Bezug auf die Figuren näher erläutert. Es zeigen:

Figur 1A
eine Schnittansicht einer Verbindungsvorrichtung gemäß einem ersten Ausführungsbeispiel der Erfindung;
Figur 1B
die Verbindungsvorrichtung aus Figur 1A in einer perspektivischen Darstellung gemäß einer ersten Ansicht;
Figur 1C
die Verbindungsvorrichtung aus Figur 1A in perspektivischer Darstellung gemäß einer zweiten Ansicht;
Figur 2A
eine Schnittansicht der Verbindungsvorrichtung aus Figur 1A mit einem an ihrem ersten Abschnitt angeordneten ersten Reservoir;
Figur 2B
die Verbindungsvorrichtung aus Figur 2A in einer ersten perspektivischen Ansicht;
Figur 2C
die Verbindungsvorrichtung aus Figur 2A in einer zweiten perspektivischen Ansicht;
Figur 2D
das Durchstechelement der Verbindungsvorrichtung aus Figur 2A in perspektivischer Ansicht;
Figur 3A
eine Seitenansicht des Durchstechelementes der Verbindungsvorrichtung aus Figur 1A;
Figur 3B
eine Schnittansicht des Durchstechelementes aus Figur 3A;
Figur 3C
eine Schnittansicht des Durchstechelementes aus Figur 3A senkrecht zu seiner Längsrichtung;
Figur 3D
eine perspektivische Ansicht des Durchstechelementes der Figur 3A;
Figur 4A
die perspektivische Ansicht des Durchstechelementes aus Figur 3D mit einer Ablauföffnung;
Figur 4B
die perspektivische Ansicht des Durchstechelementes aus Figur 4A mit einer weiteren Ausführungsform einer Ablauföffnung;
Figur 4C
die perspektivische Ansicht des Durchstechelementes aus Figur 4A mit einer Vielzahl an Ablauföffnungen;
Figur 5A
eine Schnittansicht der Verbindungsvorrichtung aus Figur 1A mit einem Durchstechelement und eingebrachten Ablauföffnungen in einer Sperrstellung; und
Figur 5B
eine Schnittansicht der Verbindungsvorrichtung aus Figur 5A mit einem Reservoir und dem Durchstechelement und den eingebrachten Ablauföffnungen in einer Öffnungsstellung.
The invention will be explained in more detail below with reference to exemplary embodiments with reference to the figures. Show it:
Figure 1A
a sectional view of a connecting device according to a first embodiment of the invention;
FIG. 1B
the connection device Figure 1A in a perspective view according to a first view;
Figure 1C
the connection device Figure 1A in a perspective view according to a second view;
FIG. 2A
a sectional view of the connecting device Figure 1A with a first reservoir disposed at its first portion;
FIG. 2B
the connection device FIG. 2A in a first perspective view;
Figure 2C
the connection device FIG. 2A in a second perspective view;
FIG. 2D
the piercing element of the connecting device FIG. 2A in perspective view;
FIG. 3A
a side view of the piercing element of the connecting device Figure 1A ;
FIG. 3B
a sectional view of the piercing element FIG. 3A ;
FIG. 3C
a sectional view of the piercing element FIG. 3A perpendicular to its longitudinal direction;
Figure 3D
a perspective view of the piercing element of FIG. 3A ;
FIG. 4A
the perspective view of the piercing element Figure 3D with a drain opening;
FIG. 4B
the perspective view of the piercing element FIG. 4A with a further embodiment of a drain opening;
FIG. 4C
the perspective view of the piercing element FIG. 4A with a plurality of drain holes;
FIG. 5A
a sectional view of the connecting device Figure 1A with a piercing element and introduced drainage openings in a blocking position; and
FIG. 5B
a sectional view of the connecting device FIG. 5A with a reservoir and the piercing element and the introduced drainage openings in an open position.

Die in Figur 1A gezeigte erfindungsgemäße Verbindungsvorrichtung 1 weist einen ersten (oberen) Abschnitt 11 zum Anordnen eines (in Fig. 1A nicht dargestellten) ersten Reservoirs in Form eines Wirkstoffbehälters sowie einen zweiten Abschnitt 12 zum Anordnen eines zweiten Reservoirs (nicht dargestellt) in Form eines Beutels, z.B. in Form eines Infusionsbeutels, auf. Der erste und der zweite Abschnitt 11, 12 sind einstückig miteinander verbunden, d.h. aus einem einstückigen Adapterteil gebildet, das zum Beispiel aus einem Kunststoff wie Polypropylen oder Polykarbonat besteht. Eine einstückige Ausbildung des ersten und des zweiten Abschnitts ist jedoch nicht unbedingt erforderlich. Es ist auch möglich, dass der erste und der zweite Abschnitt separate Teile sind, die über Verbindungsmittel miteinander verbunden sind.In the Figure 1A shown connecting device 1 according to the invention 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. However, 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.

Die Verbindungsvorrichtung 1 weist darüber hinaus ein längliches Durchstechelement in Form einer Hohlnadel 2 auf. Die Hohlnadel 2 besitzt ein Durchstechende in Form einer Nadelspitze 21, mit der die Hohlnadel 2 einen Verschluss des Medizinbehälters durchsticht, wenn dieser in den ersten Abschnitt 11 der Verbindungsvorrichtung eingesetzt wird (vgl. Fig. 2A).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 ).

Des Weiteren ist die Hohlnadel 2 so in einer Durchgangsöffnung 3 der Verbindungsvorrichtung angeordnet, dass sie axial aus einer in Figur 1A gezeigten ersten Position in eine zweite Position (Figur 2A) bewegbar ist. In der ersten Position blockiert die Hohlnadel 2 eine Strömungsverbindung zwischen dem ersten Abschnitt 11 und dem zweiten Abschnitt 12, d.h. die Verbindungsvorrichtung ist geschlossen. Somit wird z.B. verhindert, dass aus einem bereits vor dem Anordnen des Wirkstoffbehälters an dem zweiten Abschnitt 12 der Verbindungsvorrichtung befestigten zweiten Reservoir Flüssigkeit (oder eine andere in dem zweiten Reservoir befindliche Substanz) austritt.Furthermore, 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. In the first position, 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. Thus, for example, liquid (or another substance located in the second reservoir) that exits from a second reservoir, which is already secured to the second section 12 of the connecting device before the active substance container is arranged, is prevented from escaping.

Wird nun der Wirkstoffbehälter 5 in den als becherartige Aufnahme gestalteten ersten Abschnitt 11 der Verbindungsvorrichtung 1 eingesetzt, drückt die Nadelspitze 21 gegen einen Verschluss 51 des Wirkstoffbehälters 5 oder dringt teilweise in den Verschluss 51 ein. Zudem wird die Hohlnadel 2 aufgrund des Kontaktes des Verschlusses 51 mit der Außenseite der Hohlnadel beim Bewegen des Wirkstoffbehälters 5 in Richtung auf den zweiten Abschnitt 12 zu (d.h. nach unten) in eine zweite Position gedrückt, wie in Fig. 2A dargestellt.If the active substance container 5 is now inserted into the first section 11 of the connecting device 1 designed as a cup-like receptacle, the needle tip 21 presses against a closure 51 of the active substance container 5 or partially penetrates into the closure 51. In addition, due to the contact of the shutter 51 with the outside of the hollow needle, 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.

Die zweite Position der Hohlnadel 2 ist durch einen Anschlag 63 des zweiten Abschnitts 12 festgelegt, wobei die Hohlnadel über die Bewegung des Wirkstoffbehälters 5 gegen den Anschlag 63 gedrückt wird. Bei einem Weiterbewegen des Wirkstoffbehälters 5, nachdem die Hohlnadel an dem Anschlag 63 zur Anlage gekommen ist, wird die Hohlnadel 2 den Verschluss 51 vollständig durchdringen, so dass eine Strömungsverbindung zwischen dem Wirkstoffbehälter und der Hohlnadel hergestellt wird.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. 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.

Es wird darauf hingewiesen, dass es auch möglich ist, dass die Hohlnadel den Verschluss 51 des Wirkstoffbehälters bereits vollständig durchdringt, bevor die Hohlnadel an dem Anschlag 63 anliegt, wobei eine Bewegung der Hohlnadel in die zweite Position insbesondere aufgrund der Reibung zwischen der Außenseite der Hohlnadel und dem an der Außenseite der Hohlnadel anliegenden Abschnitt des Verschlusses 51 erfolgt.It should be noted that it is also possible that 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.

In dieser zweiten Position besteht eine Strömungsverbindung zwischen dem ersten Abschnitt 11 und dem zweiten Abschnitt 12, so dass über die Hohlnadel 2 Wirkstoff aus dem Wirkstoffbehälter 5 in einen am zweiten Abschnitt 12 der Verbindungsvorrichtung angeordneten Beutel gelangen bzw. auch umgekehrt eine Substanz aus einem am zweiten Abschnitt angeordneten Beutel in den Wirkstoffbehälter befördert werden kann, um den Wirkstoff aufzulösen, zu verdünnen oder zu mischen. In der zweiten Position der Hohlnadel ist die Verbindungsvorrichtung also geöffnet.In this second position there is a flow connection between the first portion 11 and the second portion 12, so that pass through the hollow needle 2 active substance from the drug container 5 in a arranged on the second portion 12 of the connecting device bag or vice versa, a substance from one on the second Section arranged pouches can be conveyed into the drug container to dissolve the drug, to dilute or to mix. In the second position of the hollow needle, the connecting device is thus opened.

Wie erwähnt, ist der erste Abschnitt 11 der Verbindungsvorrichtung becherartig ausgebildet, d.h. er weist eine Seitenwand 111 auf sowie einen Bodenbereich 112, der im Wesentlichen senkrecht zu der Seitenwand orientiert ist. Der erste Abschnitt kann eine Andockposition und eine Endposition (Aktivierungsposition) besitzen (s.u.). Selbstverständlich muss der Bodenbereich nicht unbedingt plan verlaufen, sondern kann z.B. auch eine Krümmung aufweisen. In dem Bodenbereich 112 befindet sich eine zentrale Öffnung 1121, die einen Teilbereich der Durchgangsöffnung 3 ausbildet und für eine Führung der Hohlnadel 2 sorgt. Um eine möglichst stabile Führung der Hohlnadel zu realisieren, weist der Bodenbereich 112 eine die Öffnung 1121 ringartig umgebende Verdickung auf.As mentioned, 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). Of course, the floor area does not necessarily have to be flat, but may be e.g. also have a curvature. In 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. In order to realize the most stable possible guidance of the hollow needle, the bottom portion 112 has a thickening surrounding the opening 1121 in an annular manner.

Der zweite Abschnitt 12 der Verbindungsvorrichtung 1 ist im Wesentlichen hohlzylindrisch ausgestaltet, wobei in einem Zwischenbereich des Adapterteils 100 zwischen dem ersten und dem zweiten Abschnitt ein elastisches Element in Form einer Membran 4 angeordnet ist, z.B. eingeklemmt oder stoffschlüssig mit dem Adapterteil 100 verbunden ist. Die Membran 4 weist eine zentrale, mit der Öffnung 1121 des ersten Abschnitts 11 fluchtende Öffnung 41 auf, die einen zweiten Teilbereich der Durchgangsöffnung 3 darstellt. Ein Teilabschnitt 42 der Membran 4, der lippenartig (vom Rest der Membran abgekrümmt) an eine Außenseite der Hohlnadel 2 dicht anliegt, bildet somit einen Randabschnitt der Durchgangsöffnung 3 aus.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.

Durch das Anliegen des Teilabschnitts 42 kann eine gewisse Klemmung der Hohlnadel 2 erfolgen, die zwar ihre axiale Bewegbarkeit in der Durchgangsöffnung nicht behindert, jedoch ein ungewolltes Abrutschen der Hohlnadel in Richtung auf den zweiten Abschnitt 12 der Verbindungsvorrichtung verhindern kann. Zudem dichtet die Membran, wie weiter unter beschrieben, die Verbindungsvorrichtung ab.Due to the abutment of the section 42, a certain clamping of the hollow needle 2 can take place, which, while not hindering its axial mobility in the passage opening, can prevent unwanted slippage of the hollow needle in the direction of the second section 12 of the connection device. In addition, as further described below, the membrane seals the connection device.

Es wird darauf hingewiesen, dass die Öffnung 41 in der Membran 4 bereits vor dem Anordnen des Durchstechelementes als Aussparung in der Membran vorhanden gewesen sein kann. Es ist jedoch auch möglich, dass die Membran zunächst durchgehend ausgebildet war und das Durchstechelement durch die Membran hindurchgestochen wurde.It should be noted that 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.

Die Hohlnadel 2 weist einen als Hohlraum 22 ausgeformten Kanal auf, der sich von einer in ihrer Spitze 21 angeordneten Eintrittsöffnung 211 bis zu zwei Austrittsöffnungen 23, die sich im Bereich des anderen, stumpfen Endes 212 der Hohlnadel radial gegenüberliegen, erstreckt.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.

Die im Ausführungsbeispiel der Figuren 1A und 2A gezeigten Austrittsöffnungen 23 verlaufen zwar im Wesentlichen radial, d.h. senkrecht zur Längserstreckungsrichtung der Hohlnadel 2. Es ist jedoch auch denkbar, dass zusätzlich oder alternativ anders ausgestaltete Austrittsöffnungen vorgesehen werden, zum Beispiel solche, die sich überwiegend entlang der Haupterstreckungsrichtung der Hohlnadel 2 erstrecken.In the embodiment of the Figures 1A and 2A Although shown outlet openings 23 extend substantially radially, ie perpendicular to the longitudinal direction of the hollow needle 2. However, it is also conceivable that additionally or alternatively differently configured outlet openings are provided, for example, those extending predominantly along the main extension direction of the hollow needle 2.

Das der Spitze 21 abgewandte Ende 212 der Hohlnadel 2 weist zudem einen etwas größeren Außendurchmesser als der Bereich der Spitze 21 bzw. der in der Öffnung 1121 des ersten Abschnitts 11 angeordnete Teilabschnitt der Hohlnadel auf. Der Randabschnitt 42 der Membran 4 liegt in der ersten Position der Hohlnadel 2 an dem Endbereich 212 an, so dass sich die Austrittsöffnungen 23 oberhalb, d.h. auf einer der Spitze 211 (bzw. dem ersten Abschnitt 11) zugewandten Seite des anliegenden Randabschnitts 42, befinden, wodurch eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt 11, 12 über den Hohlraum 21 der Hohlnadel 2 und die Austrittsöffnungen 22 blockiert ist.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.

Es wird darauf hingewiesen, dass sich die Austrittsöffnungen unterhalb des Bodens 112 des ersten Abschnitts befinden und somit in Sperrstellung der Hohlnadel eine gewisse Strömungsverbindung zwischen dem ersten Abschnitt und dem Bereich des Adapterteils 100 zwischen dem Boden 112 und dem anliegenden Randabschnitt 42 besteht. Dieser Bereich gehört entsprechend nicht zu dem "zweiten Abschnitt" 12 der Verbindungsvorrichtung, der vielmehr erst unterhalb der Position der Austrittsöffnungen (bezogen auf die erste Position der Hohlnadel), insbesondere unterhalb der Membran 4, beginnt.It should be noted that the 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.

Wird die Hohlnadel 2, wie in Figur 2A gezeigt, beim Einsetzen des Wirkstoffbehälters 5 in die zweite Position bewegt, gelangen die Austrittsöffnungen 22 in den zweiten Abschnitt 12 hinein, d.h. sie befinden sich dann unterhalb (auf einer der Nadelspitze 21 abgewandten Seite) des anliegenden Randabschnitts 42 der Membran 4, so dass über die Austrittsöffnungen 22 eine Strömungsverbindung zwischen dem ersten und dem zweiten Abschnitt 11, 12 besteht.If the hollow needle 2, as in FIG. 2A shown, 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.

Da, wie in Figur 2A gezeigt, nach dem Anordnen des Wirkstoffbehälters 5 die Spitze 21 und damit die Eintrittsöffnung 211 der Hohlnadel 2 den Verschluss 51 des Wirkstoffbehälters 5 durchdrungen hat und sich im Innern des Wirkstoffbehälters 5 befindet, wird über die Hohlnadel 2 eine Strömungsverbindung zwischen dem Wirkstoffbehälter 5 und einem an dem zweiten Abschnitt 12 angeordneten Beutel (nicht dargestellt) hergestellt.There, as in FIG. 2A shown after arranging the drug container 5, the tip 21 and thus the inlet opening 211 of the hollow needle 2 has penetrated the closure 51 of the drug container 5 and is located inside the drug container 5, via the hollow needle 2 is a flow connection between the drug reservoir 5 and a the second section 12 arranged bags (not shown) produced.

Das zweite Reservoir, d.h. der nicht dargestellte medizinische Beutel, wird gemäß Figur 1A über ein weiteres Element in Form eines Verbindungsstücks 6, das an dem zweiten Abschnitt 12 der Verbindungsvorrichtung 1 festgelegt ist, an dem zweiten Abschnitt 12 angeordnet. Dieses Verbindungsstück 6 weist an seinem der Verbindungsvorrichtung 1 abgewandten Ende flügelartige Ausleger 61 auf, die in eine Öffnung des Beutels eingeführt und der Beutel mit den Auslegern 61 oder mit einem Bereich oberhalb der Ausleger verbunden (zum Beispiel verschweißt oder verklebt) werden kann. An seinem den Auslegern 61 abgewandten Ende 62 weist das Verbindungsstück 6 zum Beispiel Verbindungsstrukturen auf, z.B. Raststrukturen, über die es mit dem zweiten Abschnitt 12 der Verbindungsvorrichtung 1 verbunden ist. Darüber hinaus wird die Membran 4 durch das Verrasten des Verbindungsstücks 6 mit der Verbindungsvorrichtung 1 so geklemmt, dass die Membran 4 auch eine Dichtung zwischen dem Verbindungsstück 6 und der Verbindungsvorrichtung realisiert.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. At its end 62 facing away from the arms 61, 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. In addition, 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.

Darüber hinaus weist auch der erste Abschnitt 11 der Verbindungsvorrichtung Strukturen auf, über die der Wirkstoffbehälter 5 an dem ersten Abschnitt lösbar festgelegt werden kann oder die zumindest ein Herausrutschen nach oben (d.h. entgegen der Einsetzrichtung) verhindern. Diese Strukturen umfassen Vorsprünge 110, die von der Innenseite der Seitenwand 111 nach innen abstehen und nach Einsetzen des Wirkstoffbehälters einen Rand seines Halses hintergreifen können. Der Wirkstoffbehälter 5 wird so in den ersten Abschnitt gedrückt, dass sich der Rand seines Halses unterhalb der Vorsprünge befindet (Endstellung). Beispielsweise wird der Wirkstoffbehälter soweit eingedrückt, bis der Hals (oder Kopf) auf dem Boden 112 des ersten Abschnitts aufsetzt.In addition, 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.

Darüber hinaus sind auch an einem Rand einer Öffnung 1111 des ersten Abschnitts 11, über die der Wirkstoffbehälter 5 in den ersten Abschnitt 11 eingesetzt wird, Vorsprünge 110' vorhanden, wobei der Wirkstoffbehälter 5 in einer Bereitschaftstellung an dem ersten Abschnitt 11 angeordnet sein kann, in der sich der Behälterhals (insbesondere eine Auskragung 52 des Halses) zwischen diesen Vorsprüngen 110' und den weiter unten gelegenen Vorsprüngen 110 befindet. Insbesondere wird in der Bereitschaftstellung die Hohlnadel 21 noch nicht vollständig in ihre zweite Position gedrückt, so dass die Strömungsverbindung zu dem zweiten Reservoir noch gesperrt ist. Erst wenn der Medikamentbehälter weiter nach unten in die Endstellung gedrückt wird, wird die Hohlnadel in die zweite Position bewegt.In addition, 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. In particular, 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.

Die Vorsprünge 110' können auch dazu genutzt werden, das erste Reservoir nach Verwendung (d.h. aus der zweiten Position) in die Bereitschaftsstellung zu bringen, wobei durch Bewegen des ersten Reservoirs in die Bereitschaftsstellung das Durchstechelement zurück in die erste Position mitgenommen wird, so dass die Strömungsverbindung zwischen dem ersten und dem zweiten Reservoir unterbrochen wird.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.

Darüber hinaus kann vorgesehen sein, dass die Öffnung 1111 mit einem Verschluss in Form einer Membran oder einer Folie 7 verschlossen ist, um die Verbindungsvorrichtung möglichst steril zu halten. Vor dem Einsetzen des Wirkstoffbehälters 5 wird die Folie 7 entfernt. Die Folie 7 ist z.B. eine Metall- oder Kunststofffolie (z.B. aus Aluminium oder Polypropylen).In addition, it can be provided that 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. Before inserting the drug container 5, the film 7 is removed. The film 7 is e.g. a metal or plastic film (e.g., aluminum or polypropylene).

Der die Längsbewegung der Hohlnadel 2 nach unten begrenzende Anschlag 63 wird durch das mit dem zweiten Abschnitt 12 verbundene Verbindungsstück 6 bereitgestellt. Es ist jedoch natürlich auch denkbar, dass ein derartiger Anschlag insbesondere einstückig mit dem zweiten Abschnitt 12 der Verbindungsvorrichtung ausgeformt ist.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. However, it is of course also conceivable that such a stop is in particular integrally formed with the second portion 12 of the connecting device.

Wird der in den ersten Abschnitt eingesetzte Wirkstoffbehälter nach oben (entgegen der Einsetzrichtung bzw. von dem zweiten Abschnitt 12 weg) bewegt, wird die Hohlnadel aufgrund der Reibung zwischen dem durchstochenen Verschluss 51 des Wirkstoffbehälters und der äußeren Oberfläche der Hohlnadel 21 nach oben mitgenommen. Daher gelangt die Hohlnadel 21 wieder in die Sperrposition, wenn der Wirkstoffbehälter weit genug von dem zweiten Abschnitt 12 weg bewegt wird, z.B. aus dem ersten Abschnitt 11 entfernt (d.h. vollständig von der Verbindungsvorrichtung getrennt) oder in die Bereitschaftsstellung gebracht wird.If the active substance container used in the first section is moved upwards (counter to the insertion direction or away from the second section 12), the hollow needle is carried upwards due to the friction between the pierced closure 51 of the active substance container and the outer surface of the hollow needle 21. Therefore, 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.

Die Hohlnadel 2 weist im Bereich der Austrittsöffnungen 23 einen sich von ihrer Spitze 211 weg verbreiternden konischen Abschnitt auf, der so gestaltet ist, dass ein Herausziehen der Hohlnadel 2 aus der Durchgangsöffnung 3 über die erste Position hinaus verhindert wird. Der konische Bereich der Hohlnadel 2 weist insbesondere einen Kragen auf (vgl. Figuren 3A-D), dessen Außendurchmesser größer als der Durchmesser der Öffnung 1121 des Bodenbereichs 112 des ersten Abschnitts 11 ist, so dass der Kragen bei einem Herausziehen der Hohlnadel aus der zweiten Position an dem Rand der Öffnung 1121 zur Anlage kommen wird. Insbesondere liegt der Kragen an dem Rand der Öffnung an, wenn sich die Hohlnadel in ihrer ersten Position (der Sperrposition) befindet.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. In particular, the collar abuts the edge of the opening when the hollow needle is in its first position (the blocking position).

Wie in Figur 2D gezeigt, kann die Hohlnadel 2 an ihrer Außenseite Strukturen aufweisen, die eine Reibung zwischen einem an der Außenseite anliegenden Abschnitt des Verschlusses 51 des Wirkstoffbehälters 5 erhöhen, so dass die Reibung zu dem anliegenden Teilabschnitt des Verschlusses im Bereich des reibungserhöhten Bereiches größer ist als außerhalb des reibungserhöhten Bereiches.As in FIG. 2D 2, 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.

Beispielsweise weist der reibungserhöhte Bereich der Außenseite der Hohlnadel 2 eine Mehrzahl sich kreuzender Vertiefungen 2100 oder Erhöhungen auf. Es ist auch denkbar, dass die Außenseite zusätzlich oder alternativ lediglich aufgeraut ist oder mit einer Beschichtung versehen ist, die einen im Vergleich zur Außenseite der Hohlnadel erhöhten Reibungskoeffizienten zu dem Material des Verschlusses 51 des Behälters besitzt. Insbesondere weist der reibungserhöhte Bereich der Hohlnadelaußenseite einen Reibungskoeffizienten auf, der größer ist als der Reibungskoeffizient zwischen dem Abschnitt der Hohlnadelaußenseite, an dem in der zweiten Position der Hohlnadel der oben erwähnte Abschnitt 42 des elastischen Elements anliegt, so dass bei Bewegen des Wirkstoffbehälters 5 aus der Endstellung (Fig. 2A) nach oben die Hohlnadel 2 nach oben mitgenommen und in ihre erste Position zurückgeholt wird.For example, 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. In particular, 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.

Die reibungserhöhende Struktur bzw. Beschichtung erstreckt sich insbesondere nur außerhalb des Bereiches der Hohlnadel 2, der in deren zweiter Position mit dem Randabschnitt 42 des elastischen Elementes 4 in Kontakt ist. Natürlich sind die reibungserhöhende Struktur oder Beschichtung nur optional. Es ist auch denkbar, dass die Hohlnadel auch ohne das Vorhandensein reibungserhöhender Mittel durch Bewegen des Wirkstoffbehälters aus dem ersten Abschnitt in die erste Position mitgenommen wird.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. Of course, 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.

Die Figuren 3A bis 3D zeigen die Hohlnadel 21 aus den Figuren 1A und 2A noch einmal im Detail. Es ist insbesondere zu erkennen, dass die Austrittsöffnungen 23 in einem konischen Teilbereich 210 angeordnet sind, der sich zur Nadelspitze 21 hin verjüngt. Der konische Teilbereich 210 erstreckt sich zwischen einem ersten hohlzylindrischen Bereich 240 und einem zweiten hohlzylindrischen Bereich 250, der das zweite Ende 212 der Hohlnadel 21 ausbildet und der einen größeren Außendurchmesser als der erste hohlzylindrische Bereich 240 aufweist.The 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.

Zwischen dem konischen Bereich 210 und dem zweiten Teilbereich 250 befindet sich ein Kragen 255, der einen noch größeren Außendurchmesser als der zweite Teilbereich 250 besitzt und der in der ersten Position der Hohlnadel 2 (vgl. Figur 1A) in den Randabschnitt 42 des elastischen Elements 4 eindrückt.Between the conical region 210 and the second partial region 250 there is a collar 255, which has an even larger outer diameter than the second partial region 250 and which in the first position of the hollow needle 2 (cf. Figure 1A ) is pressed into the edge portion 42 of the elastic element 4.

Gemäß Figur 3B haben die Austrittsöffnungen 23 in einem Schnitt entlang einer zur Längsachse der Hohlnadel parallelen Ebene einen zumindest näherungsweise rechteckigen Querschnitt. Selbstverständlich sind jedoch, wie bereits oben erwähnt, auch andere Ausgestaltungen der Austrittsöffnungen denkbar. Das der Spitze 21 gegenüberliegende Ende 212 der Hohlnadel 2 bildet ein geschlossenes Ende aus, so dass in der zweiten Position der Hohlnadel (Fig. 2A) die Strömungsverbindung zwischen dem Wirkstoffbehälter und dem zweiten Reservoir nur über die Eintrittsöffnung 211, den Hohlraum 22 sowie die Austrittsöffnungen 23 besteht.According to FIG. 3B 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. Of course, however, as already mentioned above, other embodiments of the outlet openings conceivable. 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.

Die Figuren 4A bis 4C zeigen jeweils ein Durchstechelement 2 mit verschiedenen Ausführungsformen einer Ablauföffnung 260. Eine Ablauföffnung 260 stellt einen Durchgang dar für den Inhalt, beispielsweise eine Flüssigkeit, des ersten Reservoirs in Richtung des zweiten Reservoirs oder umgekehrt. Die Ablauföffnungen 260 sind in dem Mantel des Durchstechelements 2 eingebracht. Sie sind zwischen der Eintrittsöffnung 211 und der Austrittsöffnung 23 positioniert. Sie können unterschiedliche Formen und/oder Größen besitzen.The 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.

Als ein Beispiel ist in Figur 4A eine Ablauföffnung 260 mit länglicher Form dargestellt, welche sich entlang der Längsachse des Durchstechelements 2 erstreckt. Figur 4B zeigt ebenso eine Ablauföffnung 260 mit länglicher Form, die sich aber quer zur Längsachse des Durchstechelements 2 erstreckt. Die Länge einer Ablauföffnung 260 kann in einer Größenordnung von 5 mm bis 15 mm liegen. Figur 4C zeigt eine Vielzahl von kleinen, beispielsweise runden, Ablauföffnungen 260.As an example, in 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.

Um die Wirkungsweise der Ablauföffnungen 260 zu illustrieren, zeigen abschließend die Figuren 5A und 5B die Verbindungsvorrichtung 1 ohne ein angeschlossenes Reservoir 5 und dem Durchstechelement 2 in seiner ersten Position, in welcher der Kanal, hier die Austrittsöffnung 23 des Kanals, geschlossen ist (Figur 5A) und mit angeschlossenem Reservoir 5 und dem Durchstechelement 2 in seiner zweiten Position, in welcher der Kanal, hier die Austrittsöffnung 23 des Kanals, geöffnet oder freigegeben ist (Figur 5B). Die Ablauföffnungen 260 sind oberhalb der Auslassöffnung 23 in dem Mantel des Durchstechelements 2 eingebracht. Die Ablauföffnungen 260 sind soweit entlang der Längsachse des Durchstechelements 2 nach oben, in Richtung auf die Eintrittsöffnung 211, verschoben oder angeordnet, dass sie bei eingesetztem Vial (als ein Beispiel für ein Reservoir 5) und damit heruntergedrücktem Durchstechelement 2, dem Innenraum des Vials 5 zugeordnet sind. Sie erstrecken sich zumindest abschnittsweise, vorzugsweise vollständig, in den Innenraum des Vials 5. Die Restmenge in dem Vial 5, die sich unterhalb der Eintrittsöffnung 211 des Durchelements 2 befindet, könnte ohne die Ablauföffnungen 260 nicht aus dem Vial 5 ablaufen und somit nicht genutzt werden. Durch die Ablauföffnungen 260 kann die Restmenge in dem angeschlossenen Vial 5 möglichst gering gehalten werden. Die Position der Ablauföffnungen 260 in dem Durchstechelement 2 sind so gewählt, dass die Ablauföffnungen 260 sich zumindest abschnittsweise, vorzugsweise vollständig oberhalb des Verschlusses 51, insbesondere der Dichtung des Verschlusses 51, sind. Vorzugsweise grenzen die Ablauföffnungen 260 an die Dichtung des Verschlusses 51.To illustrate the operation of the drain holes 260, finally 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. Preferably, the drain holes 260 are adjacent to the seal of the shutter 51.

BezugszeichenlisteLIST OF REFERENCE NUMBERS

11
Verbindungsvorrichtungconnecting device
22
Hohlnadelcannula
33
DurchgangsöffnungThrough opening
44
Membranmembrane
55
Wirkstoffbehälterdrug container
66
Verbindungsteilconnecting part
77
Foliefoil
1111
erster Abschnittfirst section
1212
zweiter Abschnittsecond part
2121
Spitzetop
2222
Hohlraumcavity
2323
Austrittsöffnungoutlet opening
4141
Öffnungopening
4242
Randabschnittedge section
5151
Verschlussshutter
5252
Auskragungprojection
6161
Auslegerboom
6262
EndeThe End
6363
Anschlagattack
100100
Adapterteiladapter part
110, 110'110, 110 '
Vorsprunghead Start
111111
SeitenwandSide wall
112112
Bodenbereichfloor area
210210
konischer Bereichconical area
211211
Eintrittsöffnunginlet opening
212212
EndeThe End
240240
erster Teilbereichfirst subarea
250250
zweiter Teilbereichsecond subarea
255255
Kragencollar
260260
Ablauföffnungdrain hole
11111111
Öffnungopening
11211121
Öffnung BodenbereichOpening floor area
21002100
Vertiefungdeepening

Claims (14)

  1. Connecting device for connecting a first reservoir in the form of a medicament container to a second reservoir, with
    - a first section (11) for arrangement of the first reservoir (5) closed with a seal (51);
    - a second section (12) for arrangement of the second reservoir; and
    - a piercing element (2) which, when the first reservoir (5) is arranged on the first section (11), penetrates the seal (51) of the first reservoir (5) with a piercing end (21), wherein
    the piercing element (2) has a channel and is movable from a first position to a second position, and,
    in the first position, the channel of the piercing element (2) is closed and a flow connection between the first section (11) and second section (12) is blocked, whereas,
    in the second position, the channel of the piercing element (2) is freed and a flow connection between the first section (11) and second section (12) is permitted,
    characterized in that the piercing element (2) is arranged movably, in a through-opening (3), relative to the first section (11) and second section (12).
  2. Connecting device according to Claim 1, characterized in that the piercing element (2) is moved to the second position when the first reservoir (5) is arranged on the first section (11) such that it is brought to an end position relative to the first section (11), wherein the piercing element (2) is designed and arranged such that it can be moved back to the first position by movement of the first reservoir (5) from the end position and away from the second section (12) of the connecting device (1).
  3. Connecting device according to Claim 1, characterized in that,
    - in the second position of the piercing element (2), a flow connection exists between the first section (11) and second section (12) of the connecting device (1) via the channel, wherein
    - in the first position of the piercing element (2), an edge section of the through-opening (3) bears on the piercing element (2) and blocks a flow connection between the first section (11) and second section (12) via the channel.
  4. Connecting device according to Claim 3, characterized in that the channel is designed in the form of a cavity (22) which extends in the interior of the piercing element (2) and which runs from an inlet opening (211), located in the area of its piercing end (21), to at least one outlet opening (23).
  5. Connecting device according to Claim 4, characterized in that the outlet opening (23) is arranged such that, in the first position of the piercing element (2), it is located on a side of the edge section of the through-opening (3) facing towards the piercing end (21) and, in the second position of the piercing element (2), it is located on a side of the edge section of the through-opening (3) facing away from the piercing end (21),
    in particular wherein the piercing element (2) is designed as a hollow body, preferably a substantially hollow cylinder, and the outlet opening (23) extends substantially radially, wherein the end of the piercing element (2) remote from the piercing end is designed closed.
  6. Connecting device according to one of the preceding claims, characterized in that the channel is formed as a depression in an outer surface of the piercing element (2).
  7. Connecting device according to one of Claims 1 to 6, characterized in that the through-opening (3) is delimited by an elastic element, at least in the area of its edge section that closes the channel of the piercing element (2) in the first position of the piercing element,
    in particular wherein the channel of the piercing element (2) is closed by the elastic element in the first position.
  8. Connecting device according to Claim 7, characterized in that, in the first position, the piercing element (2) extends into the elastic element or through the elastic element.
  9. Connecting device according to Claim 7 or 8 when referred back to Claim 4, characterized in that the edge section of the through-opening bearing on the piercing element (2) is formed by a partial section of the elastic element, wherein in the first position of the piercing element (2) the outlet opening (23) is closed by this partial section or the outlet opening (23) is located on a side of this partial section of the elastic element facing towards the first section (11) of the connecting device.
  10. Connecting device according to Claim 8 or 9, characterized in that the elastic element is designed in the manner of a membrane (4), wherein the piercing element (2) runs through the membrane (4), and the partial section bearing on the piercing element (2) is formed by a partial section (42) of the membrane (4) that rests like a lip on the outer surface of the piercing element (2),
    in particular wherein the piercing element (2) runs through an opening formed as a recess in the membrane (4) or is pushed through an originally continuous section of the membrane (4).
  11. Connecting device according to one of Claims 1 to 10, characterized in that the first section (11) is configured in the form of a cup-like receptacle, and a bottom (112) of the first section (11) has an opening (1121), which forms a partial area of the through-opening (3).
  12. Connecting device according to one of the preceding claims, characterized in that the piercing element (2) has means for increasing a frictional force between an outer surface of the piercing element (2) and a section of the seal (51) of the first reservoir (5) which, after penetration of the piercing end (21) of the piercing element (2), bears on the outer surface of the piercing element (2), wherein the means for increasing the frictional force comprise friction-increasing structures in the outer surface of the piercing element (2), in particular a roughing of the outer surface, and/or a friction-increasing coating arranged on the outer surface of the piercing element,
    in particular wherein the connecting device has a limit stop (63), which defines the second position of the piercing element (2).
  13. Connecting device according to one of the preceding claims, characterized in that the piercing element (2) has at least one discharge opening (260),
    in particular wherein the discharge opening (260) is formed in a jacket of a piercing element (2) designed at least in part as a hollow body, preferably in a substantially hollow cylindrical piercing element (2).
  14. Connecting device according to one of the two preceding claims, characterized in that the discharge opening (260) is arranged in the piercing element (2) in such a way that, when the piercing element (2) is in the second position, in which a flow connection is permitted between the first section (11) and second section (12), said discharge opening (260) is located at least in part in an interior of a reservoir (5) arranged on the first section (11).
EP20120703005 2011-01-25 2012-01-25 Connecting device for connecting a first reservoir to a second reservoir Not-in-force EP2667838B1 (en)

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US201161435800P 2011-01-25 2011-01-25
EP11151942 2011-01-25
EP20120703005 EP2667838B1 (en) 2011-01-25 2012-01-25 Connecting device for connecting a first reservoir to a second reservoir
PCT/EP2012/051153 WO2012101178A1 (en) 2011-01-25 2012-01-25 Connecting device for connecting a first reservoir to a second reservoir

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JP (1) JP2014506494A (en)
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JP2014506494A (en) 2014-03-17
US20120192976A1 (en) 2012-08-02
CN103402483B (en) 2015-11-25
BR112013018834A2 (en) 2017-01-31
CL2013002120A1 (en) 2014-04-04
ES2531146T3 (en) 2015-03-11
WO2012101178A9 (en) 2012-11-01
AU2012210586B2 (en) 2016-03-17
EP2667838A1 (en) 2013-12-04
US8857470B2 (en) 2014-10-14
MX2013008565A (en) 2013-08-21
HK1191847A1 (en) 2014-08-08
CA2825251A1 (en) 2012-08-02
ZA201305476B (en) 2014-10-29
CN103402483A (en) 2013-11-20
WO2012101178A1 (en) 2012-08-02

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