EP4203889A1 - Dispositif de couplage pour un adaptateur pour un flacon, adaptateur pour un flacon, ensemble comprenant un tel adaptateur, et système comprenant un tel adaptateur - Google Patents

Dispositif de couplage pour un adaptateur pour un flacon, adaptateur pour un flacon, ensemble comprenant un tel adaptateur, et système comprenant un tel adaptateur

Info

Publication number
EP4203889A1
EP4203889A1 EP21773293.2A EP21773293A EP4203889A1 EP 4203889 A1 EP4203889 A1 EP 4203889A1 EP 21773293 A EP21773293 A EP 21773293A EP 4203889 A1 EP4203889 A1 EP 4203889A1
Authority
EP
European Patent Office
Prior art keywords
vial
adapter
coupling device
neck
elastic
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.)
Pending
Application number
EP21773293.2A
Other languages
German (de)
English (en)
Inventor
Karl Martin Berg
Florin Kopp
Varaprasad SIKHILE
Christian Walter
Johannes Bolz
Konstantin Krug-Sauer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP4203889A1 publication Critical patent/EP4203889A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing 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
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61J1/2048—Connecting means

Definitions

  • Coupling device for an adapter for a vial adapter for a vial, set comprising such an adapter and system comprising such an adapter
  • the invention relates to a coupling device for an adapter for a vial for a medical liquid, such an adapter, a set comprising such an adapter and a system comprising such an adapter.
  • a liquid containing an active ingredient can be introduced into a patient's bloodstream.
  • the liquid to be administered is often taken from a so-called vial with an injection syringe.
  • a vial is a liquid container whose opening is typically closed with a septum or an injection stopper that can be pierced with an injection needle.
  • vials are sometimes also referred to as “pierceable injection vials” or simply as “injection vials”.
  • the designations 'ampoule', 'phial' etc. are also used for vials if confusion with other types of ampoules and vials can be ruled out.
  • the liquid container of a vial is made of glass or plastic, for example. Its capacity can contain, for example, a single dose or several single doses of the liquid to be administered.
  • Vials are also filled with dry substance, since some drugs are not sufficiently stable in the dissolved state.
  • the dry substance is dissolved in a solvent placed in the vial (e.g. water or saline) before injection. solved. The solution is then removed from the vial in the manner described above.
  • Vials are also widely used in the laboratory, especially in the field of biotechnology, for manipulating liquids.
  • an adapter for the vial can be used. By connecting the adapter to the vial, a fluid connection to the interior of the vial is established, for example by a hollow mandrel or the like piercing through the septum.
  • the adapter has a fluid connection which is in fluid connection with the hollow mandrel and via which liquid can be removed from the vial or liquid can be supplied to the vial.
  • the fluid connection can be, for example, a connection for a plug-in connection, for example a connection for a Luer connection.
  • the connection preferably has a female Luer cone, since injection syringes and other devices for removing the liquid typically have a male Luer cone.
  • the luer connector can be of the "luer slip" type or of the "luer lock” type.
  • the fluid connection can, for example, also be a connection that has a different type of coupling element.
  • the adapter can be regarded as a transfer device for a medical liquid.
  • the adapter can be a gateway according to the ISO 22413:2010 standard.
  • an adapter has some key advantages. If the withdrawal of liquid from the vial or the addition of liquid to the vial is carried out using a hypodermic syringe fitted with a hypodermic needle, the septum of the vial does not have to be specially pierced. The piercing of the septum of the vial is prone to error, in particular it is often not at the right angle carried out and is associated with a risk of stab wounds. In this context, the use of an adapter is particularly advantageous if the septum would have to be pierced several times without the adapter.
  • the fluid port may be configured so that connecting to a hypodermic syringe or other device for removing or adding fluid is simpler, less prone to error, and less likely to cause injury than piercing a septum with a needle.
  • the fluid connection can be designed, for example, as a plug-in connection, for example as a female Luer connection.
  • the fluid connection can be designed in such a way that the connection to a hypodermic syringe or other device for removing or adding liquid is more secure than the connection via a needle inserted into a septum, which could easily be unintentionally pulled out again.
  • the fluid connection can be equipped with non-positive and/or positive holding means, for example.
  • the adapter offers the possibility of providing a special connection element for the respective application.
  • contamination of the environment must be avoided because contact with medical staff or other people is risky. This is the case, for example, with some cytostatics that are carcinogenic or mutagenic.
  • Such medicinal substances are therefore preferably handled in closed systems by means of so-called “closed system transfer devices” (CSTD).
  • CSTD closed system transfer devices
  • the adapter can have a connection structure suitable for this.
  • an adapter is advantageous or even necessary is the transfer of liquid between a vial and a fluid device, for example another liquid container, for example a container for an infusion solution. It can be particularly advantageous in such cases if a suitable or special for the fluid device trained adapter is traded as an accessory together with the fluid device.
  • Such adapters are known in the prior art, which can be irreversibly connected to the vials.
  • An "irreversible connection” is understood to mean a connection between two objects that cannot be detached, at least not without applying great force or damaging or destroying one of the objects.
  • Each of these adapters is designed for a specific size of vial and can only be used with vials of this size.
  • Vials typically conform to ISO 8362-1 and ISO 8536-1 standards.
  • the diameter of the neck of the vials of the various sizes is 13 mm, 20 mm, 28 mm and 32 mm (each within certain tolerances), whereby one of the two largest diameters mentioned is common in Europe (32 mm) and the other, for example, in the US (28mm).
  • one object of the invention is to provide a coupling device for an adapter for a vial for a medical liquid, with which the adapter can be improved, in particular made more universally usable.
  • the coupling device according to the invention is a coupling device for an adapter for a vial for a medical liquid.
  • the docking device is designed to connect the adapter to the vial.
  • the coupling device has an elastic structure for adapting the adapter to different sizes of the vial.
  • an adapter typically includes at least the following additional devices: a vial connection, which is designed to provide a fluid connection between an interior of the vial connected to the adapter and the adapter, and a fluid connection, which is designed to provide a fluid connection between a fluid device and the adapter, so that a fluid connection between the interior of the vials connected to the adapter and the fluidic device is provided.
  • the coupling device has an elastic structure for adapting the coupling device and thus the adapter as a whole to different sizes of the vial.
  • the coupling device preferably comprises a base body which has an opening for receiving the vial, in particular a section of the neck of the vial.
  • the elastic structure is, for example, connected to the base body or formed in one piece with it.
  • Adaptation to the size of the vial is preferably effected by deforming or deflecting the elastic structure or a part of the elastic structure, depending on the size of the respective vial.
  • the deformation or deflection in this case is greater when connected to a larger vial than when connected to a smaller vial.
  • the size of the vial that is accommodated by the elastic structure is preferably the diameter of the neck of the vial.
  • vials with a size in between e.g. neck diameter d : dmin — d — dmax
  • the width of the range (for example dmax - dmin) is preferably at least 12%, more preferably at least 25%, even more preferably at least 50% of the smallest possible size (for example dmax > 1.12 x dmin or dmax > 1.25 x dmin or dmax > 1.50 x dmin).
  • the expression that the adapter is an 'adapter for a vial' means in particular that the adapter is intended to be connected to a vial.
  • the vial is a "vial for a medical liquid”
  • the vial contains a medical liquid (water, aqueous solution, medical sample, etc.) or that it contains a medical liquid can be absorbed.
  • the adapter according to the invention is an adapter for a vial for a medicinal liquid, comprising:
  • a vial connection which is designed to provide a fluid connection between an interior of the vial connected to the adapter and the adapter
  • a fluid connection which is designed to provide a fluid connection between a fluid device and the adapter, so that a fluid connection is provided between the interior of the vial connected to the adapter and the fluid device.
  • the set according to the invention is a set comprising: a first adapter according to the invention and a second adapter for a vial for a medical liquid, wherein the first and the second adapter are designed for different sizes or size ranges of the vials, wherein the second adapter is preferably also an adapter according to one of the preceding claims and the different sizes of the vial to which the coupling device of the first adapter can be adapted are at least partially different due to the different sizes of the vial to which the coupling device of the second adapter can be adapted.
  • the system according to the invention is a system comprising: an adapter according to the invention and a fluid device, preferably a container for a medicinal liquid, more preferably a container with a medicinal liquid.
  • the vial and the fluid device are not considered part of the adapter or even part of the coupling device in the context of this patent application.
  • this information relates to the operating position of the adapter connected to a vial, in which the direction is from the bottom to the neck of the vial is the bottom-up direction or the vertical direction.
  • a lateral or horizontal direction is a direction transverse thereto.
  • 1 to 4 show partial areas of the longitudinal section of typical vials with the sizes (neck diameter) 13, 20, 28 and 32 mm with dimensions in millimeters.
  • 5 shows an adapter with a coupling device according to a first exemplary embodiment of the invention, which is connected to a vial of a first size, viewed in longitudinal section in a first lateral direction.
  • FIG. 6 shows the adapter with the coupling device according to the first exemplary embodiment of the invention connected to the vial of the first size, in a perspective view in a second lateral direction offset by 90° from the first lateral direction according to FIG is.
  • FIG. 7 shows the coupling device according to the first exemplary embodiment in a perspective view obliquely from above.
  • FIG. 8 shows the coupling device according to the first exemplary embodiment in a perspective view obliquely from below.
  • FIG 9 shows the coupling device according to the first exemplary embodiment in a perspective view in the lateral direction.
  • FIG. 10 shows the coupling device according to the first exemplary embodiment in a perspective view from above.
  • Fig. 11 A to Fig. 11 C show in comparison the situation shown in Fig. 5 (Fig. 11 A), the adapter with the coupling device according to the first embodiment of the invention, which is used with a vial of a larger size than in Fig. 5 (Fig. 11C) and an overlay of the status of the adapter of Fig. 11A and the vial of Fig. 11C.
  • 12A and 12B show two adapters with coupling devices according to the first exemplary embodiment, which are connected to vials of different sizes.
  • FIG. 13 shows a coupling device according to a second embodiment in a perspective view from above.
  • 14 shows a coupling device according to a third exemplary embodiment of the invention in a perspective view obliquely from above.
  • FIG. 15 shows the coupling device according to the third exemplary embodiment of the invention and a vial in a perspective view from the side.
  • FIG. 16A and 16B show in comparison the adapter with the coupling device according to the third embodiment of the invention, which is connected to a smaller vial (Fig. 16A) and a larger vial (Fig. 16B), respectively as a cross section through the coupling device and as a longitudinal section.
  • 17A and 17B show cross-sectional views of the coupling device according to the third embodiment in two different sizes.
  • FIGS. 18A and 18B show perspective views of the coupling device according to the third exemplary embodiment in two different sizes, obliquely from above.
  • FIG. 19 shows an adapter with a coupling device according to a fourth exemplary embodiment of the invention, which is connected to a vial, in a perspective view from the side.
  • 20A and 20B show longitudinal sectional views of the adapter with the coupling device according to the fourth exemplary embodiment, which is connected to vials of two different sizes.
  • FIGS. 1 to 4 The size ratios of typical vials, in particular those corresponding to the ISO 8362-1 standard or the ISO 8536-1 standard, and the typical manufacturing tolerances are indicated in FIGS. 1 to 4 .
  • a vial of a certain size for example a “13 mm vial” or equivalently “vial with 13 mm diameter” or “vial with 13 mm neck diameter” or “vial with the size 13 mm” or analogous designations, a vial of the specified nominal size is referred to, with tolerances of the order of magnitude shown in FIGS. 1 to 4 occurring.
  • an adapter 1 is shown with a kupplungsvoroplasty 11 according to a first embodiment of the invention.
  • the entire object shown in FIGS. 5 and 6 can therefore also be regarded as an exemplary embodiment of the adapter according to the invention.
  • the coupling device 11 or the adapter 1 is shown in an operating state in which the adapter 1 is connected to a vial 2 with a circular cross section.
  • the vial 2 is not part of the adapter 1 .
  • the vial 2 has a container body 21 with a container bottom 22 .
  • the vial 2 also has a neck 23 .
  • the neck 23 has an upper neck section 231 which forms the upper end of the vial 2 and a taper 232 with a smaller diameter than the upper neck section 231 .
  • the diameter of the upper edge section 231 is referred to.
  • the diameter of the container body 21 may differ from the diameter of the upper neck portion 231.
  • a septum 24 is provided at least in the upper neck section 231, which seals the vial 2 tightly.
  • a fastening structure can be provided for fastening the septum 24, for example in the form of a metal ring which is placed in a form-fitting manner around the upper neck section 231 and has an opening for an instrument to pierce the septum.
  • the vial 2 can also be closed with an injection stopper (not shown in FIGS. 5 and 6).
  • other pierceable closures are possible. The closure need not necessarily seal when an instrument that has been used to pierce it to establish fluid communication is withdrawn.
  • the coupling device 11 is designed to be connected to a vial 2 with a circular cross section. Vials with a different cross section, for example with an oval cross section, are at least conceivable.
  • the coupling device 11 is designed to be connected to vials which have a non-circular cross section.
  • FIG. 7 also shows an optional connecting surface 3 for connecting the coupling device 11 to the other components of the adapter 1, preferably by ultrasonic welding.
  • the connecting surface 3 has optional energy-conducting elements 31 to simplify ultrasonic welding.
  • the coupling device 11 comprises snap hooks 111 as a latching structure, which snaps into place when the vial 2 is connected to the coupling device 11 or the adapter 1 on the vial 2 by snapping the snap hooks 111 on the upper section 231 of the neck 23 of the vial when the adapter 1 is attached to the vial 2 2 slide until they have been pushed further to the taper 232.
  • the snap hooks 111 then engage in the taper. This situation is shown in FIG.
  • the snap hooks can be referred to as "locking hooks" or similar.
  • the snap-in structure preferably snaps into place irreversibly on the vial.
  • the latching structure can be designed in such a way that it can be released again, for example by applying a release force or by actuating a release element, by which the latching can be released.
  • the snap-in structure is provided by other structures as an alternative or in addition to the at least one snap hook, for example by at least one snap-in lug ("locking lug") or at least one snap-in bead.
  • the latching structure or the elastic component thereof represents a preferred example of an elastic element, which is also referred to as “second elastic element” in the following.
  • the second elastic element is connected to another elastic element (hereinafter also “first elastic element”) and together with this forms the elastic structure for adapting the coupling device 11 to different sizes of the vial 2.
  • the second elastic element can perform its function unchanged with different deflections of the first elastic element (i.e. with different sizes of the vial).
  • the direction of deformation of the first elastic element for adapting to different vial sizes is further preferably different from the direction of deformation of the second elastic element.
  • the snap-in hooks 111 or other snap-in structures are optionally connected via a cantilever arm 112 to the first elastic element 113 described in detail below (as shown in FIGS. 7 and 8).
  • the cantilever 112 can be elastic and thus contribute to the elastic effect of the first elastic element 113 and/or the second elastic element 111 .
  • the snap hooks 111 or other snap-in structures are arranged directly on a respective first elastic element 113 (as shown in FIGS. 6 and 9).
  • the function of the first elastic element 113 or the first elastic elements 113 is shown in FIGS. 11A to 11C.
  • FIG. 11A corresponds to the situation shown in FIG. 5, in which the snap hooks 111 engage in the narrowing 232 of the vial 2, which has a certain diameter.
  • FIG. 11B does not correspond to a situation that actually occurs, but only serves to clarify the function of the first elastic elements 113.
  • the adapter 1 shown in FIG. 11B is in the same state as the adapter 1 shown in FIG. 11A.
  • the neck 23 of the vial 2 shown in FIG. 11B has a larger diameter.
  • the neck 23 cannot therefore be inserted into the coupling device. This is illustrated in FIG. 11B by the fact that the snap hooks 111 overlap areas of the vial 2, which is not really possible. This problem occurs with conventional adapters when the vial is too large to be connected to the adapter.
  • the coupling device 11 has a wall
  • the at least one first elastic element is designed in a different way, for example as an attachment to the wall or the base body of the coupling device 11 Elements.
  • the number of recesses 115 (one or more) and their shape are chosen such that the first elastic elements 113 have the desired elastic properties.
  • two or three resilient elements are coupled to one another: the snap hooks 111, optionally the cantilever arms 112 and the first elastic elements 113.
  • the spring constants are selected or matched to one another such that the individual spring elements can fulfill their described function.
  • the adaptability according to the invention to different sizes of the vial would not be achievable in the exemplary embodiment without the first elastic elements 113 .
  • the snap hooks 111 and the optional cantilever arms 112 have a significantly higher spring constant than the first elastic elements 113, or the snap hooks 111 and the optional cantilever arms 112 are not designed as spring elements ie they are essentially not deflected or deformed by the forces occurring when using the adapter 1 .
  • the spring action required for snapping in the snap hooks 111 is provided at least to a significant extent by the first elastic elements 113 .
  • the elastic structure is therefore only formed by first elastic elements 113, since there are no second elastic elements.
  • the adaptation of the coupling device 11 and thus of the adapter 1 to vials 2 with different neck diameters is achieved in the manner described.
  • the range of different neck diameters to which an adjustment is possible can include all common neck diameters (typically 13 to 32 mm). This has the advantage that an adapter 1 can be used for all standard vials 2 .
  • an adapter 1 is suitable for neck diameters of 13 to 20 mm
  • at least one additional adapter is required for larger neck diameters, which in turn can be adapted to different Neck diameter can be customizable.
  • an adapter that is so wide that it can also be connected to a vial with a neck diameter of 28 mm or even 32 mm would be relatively bulky as an adapter for a vial with a neck diameter of 13 mm.
  • often only vials with two different neck diameters are used in one and the same work space, so that adaptability to other vials is not required at all.
  • the greater the range in which adaptability is possible the greater the demands on the elastic elements.
  • the upper portion 231 is usually higher in the case of larger vials 2 than in the case of smaller vials 2. From the dimensions given in Figures 1 to 4 it can be seen that the upper portion 231 of common (Particularly standard) vials 2 with a neck diameter of 13 and 20 mm have a height of 3.6 to 3.8 mm (collectively referred to as height h1), while the upper section 231 of conventional (particularly standard) vials 2 with a neck diameter of 28 and 32 mm have a height of 5 mm (h2) and 7 mm (h3).
  • the tip of the vial connection should only protrude as far into the interior of the vial 2 as is necessary, as a protruding hollow dome or a comparable lancing device in the position of the vial 2, in which the bottom 22 points upwards and in which the vial 2 liquid is removed, as an overflow pipe acts that a Withdrawal of liquid is only permitted up to a liquid level at the level of the opening of the tip.
  • the hollow spikes or comparable lancing devices should be of different lengths depending on the diameter of the neck of the vial 2. This relationship is shown in FIG. It can also be useful if the fluid channel in the hollow mandrel or the comparable lancing device has a larger lumen when the vial is larger and therefore has a larger neck diameter, because more liquid is typically removed from a larger vial.
  • a first size with a shorter hollow dome being suitable for vials with a neck diameter of, for example, 13 to 20 mm, while one or more other sizes with a longer hollow mandrel for larger vials (e.g. 28 and/or 32 mm).
  • the coupling device 11 shows the coupling device 11 according to a second exemplary embodiment of the invention.
  • the coupling device 11 has three snap hooks 111 and accordingly three first elastic elements 113; Otherwise, the structure is analogous to the first exemplary embodiment.
  • FIG. 14 shows the coupling device 11' for an adapter 1' according to a third exemplary embodiment of the invention.
  • the docking device 11' has a wall 114' surrounding an opening in which the neck 23 of the vial 2 is received when the adapter T is connected to the vial 2.
  • the wall 114' does not have to have a closed lateral surface as shown in Fig. 14, it can also have recesses, for example, or consist of individual supports or the like.
  • At least one elastic arm 116' is formed onto the wall 114'. In the specific configuration shown in FIG. 14, three elastic arms 116' are provided, but alternatively fewer or more than three elastic arms 116' can be provided.
  • the resilient arms 116' spring in the radial direction, ie they are deflected when forces with a radial component act on the arms 116' in the direction of the wall.
  • the elastic arms 116' are in the form of flat springs which do not extend or only extend in the radial direction.
  • the resilient arms 116' are formed as curved flat springs.
  • straight elastic arms are also possible.
  • the resilient arms 116' provide a resilient structure.
  • An elastic arm 116' can optionally form a first elastic element 116a' in a first section and a second elastic element 116b' in a second section 116b'.
  • the width or height of the elastic arms 116' i.e. their dimension in the vertical direction, is selected such that the elastic arms 116' can snap into the taper 232 of the neck 23 of the vial 2.
  • the upper edge 117' and the lower edge 118' of the elastic arms 116' serve as a snap structure.
  • the lower narrow side 118′ is preferably shaped such that the elastic arm 116′ slides when the neck 23 of the vial 2 is inserted on its upper section 231 and is pressed radially outwards so that the vial 2 and the adapter T move relative to one another that the resilient arm 116' eventually snaps into place.
  • FIG. 15 shows the coupling device 11′ according to the third exemplary embodiment of the invention and a vial in a perspective view from the side.
  • the relative movement to connect adapter T and vial 2 is indicated by an arrow.
  • the front part of the wall 114' in the view is not shown in FIG. 15 so that the elastic arms 116' are visible.
  • the lower narrow side 118' designed for sliding on the upper section 231 of the neck 23 of the vial 2 is, for example, shaped in such a way that a region of the elastic arm 116' has a width that decreases toward the interior of the coupling device 11', ie the elastic arm 116' has a shape that tapers toward the free end of the elastic arm 116'.
  • FIG. 16A shows an adapter 1' with a coupling device 11' according to the third exemplary embodiment in a state in which it is connected to a vial 2 of a first size.
  • the vial connection 12 represents a fluid connection to the interior of the vial by penetrating its closure (exemplified in the figure as an injection stopper).
  • the coupling device 11' is shown in cross-section, with the concentric circles denoting the diameter of the upper section 231 (outer circle), the smallest diameter in the taper 232 (middle circle) and the opening of the vial ( small circle) symbolize.
  • Fig. 16B the same adapter 1' is shown in a state in which it is connected to a vial 2 of a second size.
  • the vial of the second size has a larger neck diameter.
  • the elastic arms 116′ which in turn engage in the taper 232, are deflected or deformed to a greater extent.
  • the adaptation of the coupling device 11' and thus of the adapter 1' to vials 2 with different neck diameters is achieved in the manner described.
  • the range of different neck diameters to which an adjustment is possible can include all common neck diameters (typically 13 to 32 mm). This has the advantage that one adapter 1' can be used for all vials.
  • an adapter 1' is suitable for neck diameters of 13 to 20 mm, while at least one additional adapter is required for larger neck diameters is required, which in turn may be adaptable to different neck diameters.
  • FIGS. 17A and 17B two sizes of the coupling device 11' are shown in cross section in FIGS. 17A and 17B, the size shown in FIG. 17A for vials 2 with a neck diameter of 13 to 20 mm and the size shown in FIG Vials 2 with a neck diameter of 28 to 32 mm is suitable. These diameters are drawn in the form of concentric circles in FIGS. 17A and 17B.
  • the coupling device 11' shown in FIGS. 17A and 17B is not connected to a vial 2, so that the arms 116' are in their rest position.
  • the coupling device 11' of the adapter 1' can be useful to reduce the residual volume to provide different configurations of the coupling device 11' of the adapter 1' for smaller vials 2 (e.g. 13 to 20 mm) and larger vials 2 (e.g. 28 to 32 mm). to prevent the hollow mandrel 12 or a corresponding lancing device, in the case of smaller vials 2, from protruding further into its interior than is necessary.
  • FIG. 19 shows an adapter 1′′ with a coupling device 11′′ according to a fourth exemplary embodiment of the invention.
  • Components that have a function that is analogous to corresponding components according to the first, second and third exemplary embodiment are identified by the same reference number, which is provided with a double inverted comma (").
  • the coupling device 11" has snap hooks 111" which are arranged at the free end of cantilever arms 112".
  • the cantilever arms 112" represent the elastic structure for adjusting the Coupling device 11" ready for different sizes of the vial, ie they are correspondingly elastically deformable.
  • a cantilever arm 112" can optionally form a first elastic element in a first section and a second elastic element in a second section.
  • FIG. 20A the adapter 1' is shown in a state in which it is connected to a vial 2 of a first size.
  • FIG. 20B shows the same adapter 1' in a state in which it is connected to a vial 2 of a second size.
  • the vial 2 of the second size has a larger neck diameter.
  • the elastic arms cantilever arms 112'' are deflected or deformed to a greater extent.
  • the coupling device 11′′ and thus the adapter 1′′ are adapted to vials 2 with different neck diameters.
  • the range of different neck diameters to which an adjustment is possible can include all common neck diameters (typically 13 to 32 mm). This has the advantage that a 1" adapter can be used for all vials.
  • an adapter 1" is suitable for neck diameters of 13 to 20 mm, while at least one additional one is suitable for larger neck diameters Adapter is required, which in turn may be adaptable to different neck diameters.
  • a coupling device 11" with five cantilever arms 112" is shown as an example in FIGS. 19, 20A and 20B. However, more or fewer than five cantilever arms 112'' can also be provided.
  • the various exemplary embodiments of the coupling device according to the invention result in various exemplary embodiments of the adapter 1, 1', 1" according to the invention.
  • the adapter 1, T, 1" according to the exemplary embodiments presented above has a hollow mandrel 12 as a vial connection.
  • the hollow mandrel 12 serves to be pierced with its tip 121 through the septum 24 (or through an alternative pierceable vial closure). , so that the opening located at the tip 121 of the fluid channel arranged inside the hollow mandrel 12 protrudes into the inside of the vial 2 .
  • the hollow mandrel 12 prefferably has one or more additional fluid channels.
  • Another fluid channel can be used, for example, to aerate the vial 2 to equalize the pressure when liquid is removed.
  • the adapter 1, T, 1′′ also has a fluid connection 13 which is designed to provide a fluid connection between a fluid device (not part of the adapter 1, 1′, 1′′ and not shown in the figures) and the adapter 1, 1′ , 1" so that a fluid connection between the interior of the vial 2 connected to the adapter 1, 1', 1" and the fluid device is provided.
  • a fluid device not part of the adapter 1, 1′, 1′′ and not shown in the figures
  • the fluid connection 13 has at least one port 131 which is in fluid connection with the vial connection 12 so that a fluid, for example a liquid, can flow from the interior of the vial 2 to the port 131 .
  • a port 131 provides a connection point for a fluid device in order to provide a fluid connection between the interior of the vial 2 connected to the adapter 1, 1', 1" and the fluid device.
  • the fluid device can be used to remove or supply fluid to the interior of the vial 2
  • the following can act as a fluid device, for example: an injection syringe without an injection needle attached, an injection syringe with an injection needle attached, another fluid container, a hose connection, etc.
  • the fluid connection 13 has a port 131, namely a port 131 in the form of a female Luer cone. In other exemplary embodiments not shown in the figures, the fluid connection 13 has more than one port.
  • the fluid connection 13 can optionally have a pressure compensation device 132, which is shown in FIGS.
  • the pressure equalization device 132 is preferably designed in such a way that no potentially harmful substances can escape from the fluid system into the environment through the pressure equalization device 132 . This is realized, for example, by a filter device.
  • the fluid connection 13 can optionally have a liquid filter 122 and/or a ventilation filter 133, as is shown in FIGS.
  • the adapter 1, T, 1" can also include other components, for example a cover for a port 131 of the fluid connection 13.
  • the vial connection 12 and the fluid connection 13 are connected to one another, for example by gluing and/or welding, in particular ultrasonic welding.
  • the vial connection 12 and the fluid connection 13 are formed in one piece.
  • the vial connection 12 and the fluid connection 13 can, for example, be designed together in the form of a withdrawal spike.
  • a typical removal spike for a medical fluid transfer system for removing medical liquids from medical containers such as vials usually has a hollow spike for piercing a septum or stopper, which spike includes a liquid channel and a ventilation channel.
  • the ventilation duct can open into an optional ventilation filter.
  • the liquid channel can open into an optional liquid filter.
  • An example of a preferred withdrawal spike is described and shown in EP 1 192 927 A2.
  • the coupling device 11 and the unit made up of the vial connection 12 and the fluid connection 13 are connected to one another, for example by gluing and/or welding, in particular ultrasonic welding.
  • the coupling device 11 is formed in one piece with the vial connection 12 or the fluid connection 13 and the third of the components mentioned is connected thereto, for example by gluing and/or welding, in particular ultrasonic welding.
  • the components of the adapter of the above-described and further exemplary embodiments preferably comprise a plastic, more preferably they are made essentially or entirely of plastic.
  • the coupling device 11, 11′, 11′′ comprises plastic, preferably made essentially or entirely of plastic, since the required elastic properties can be provided in a simple manner in this way.
  • At least the coupling device 11 is produced as a one-piece element, more preferably by injection molding a plastic material.
  • the coupling device 11, 11', 11'' is preferably designed such that the adapter can be connected to a vial 2 in accordance with the ISO 8362-1 standard or the ISO 8536-1 standard.
  • the coupling device 11, 11′, 11′′ can more preferably be adapted to at least two of the group of different diameters of the vial made up of 13 mm, 20 mm, 28 mm and 32 mm due to the elastic structure, in particular to the diameters 13 mm and 20 mm or to the diameters 28 mm and 32 mm.
  • the coupling device is designed to irreversibly connect the adapter to the vial.
  • the adaptation can preferably take place continuously, ie the coupling device is not only suitable for vials with the specifically mentioned diameters, but for all diameters of a range that contains the specifically mentioned values, for example 10 mm to 35 mm or 10 mm to 23 mm or 27mm to 33mm.
  • the set according to the invention comprises a first adapter according to an embodiment of the invention described above or another embodiment and a second adapter for a vial for a medical liquid.
  • the first and the second adapter are designed for different sizes or size ranges of the vials, i.e. the second adapter is at least also suitable for vial sizes to which the coupling device of the first adapter cannot be adapted.
  • the second adapter is also preferably an adapter according to one of the exemplary embodiments of the invention described above or another exemplary embodiment.
  • the different sizes of vial to which the coupling device of the second adapter is adaptable in this case are at least partially different from the different sizes of vial to which the coupling device of the first adapter is adaptable.
  • the system according to the invention comprises an adapter according to an embodiment of the invention described above or another one inventive set with several adapters and a fluid device.
  • the system according to the invention offers the advantage, for example, that a fluid device, for example an injection syringe, is provided with a suitable adapter that can be used for vials of different sizes.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un dispositif de couplage (11, 11', 11") pour un adaptateur (1, 1', 1") pour un flacon (2) pour un liquide médical. Le dispositif de couplage (11, 11', 11") est destiné à connecter l'adaptateur (1, 1', 1") au flacon. Le dispositif de couplage (11, 11', 11") a une structure élastique (113, 116', 112") pour ajuster l'adaptateur à différentes tailles du flacon (2).
EP21773293.2A 2020-08-28 2021-08-26 Dispositif de couplage pour un adaptateur pour un flacon, adaptateur pour un flacon, ensemble comprenant un tel adaptateur, et système comprenant un tel adaptateur Pending EP4203889A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020210898.6A DE102020210898A1 (de) 2020-08-28 2020-08-28 Kopplungsvorrichtung für einen Adapter für ein Vial, Adapter für ein Vial, Set umfassend einen derartigen Adapter und System umfassend einen derartigen Adapter
PCT/EP2021/073628 WO2022043446A1 (fr) 2020-08-28 2021-08-26 Dispositif de couplage pour un adaptateur pour un flacon, adaptateur pour un flacon, ensemble comprenant un tel adaptateur, et système comprenant un tel adaptateur

Publications (1)

Publication Number Publication Date
EP4203889A1 true EP4203889A1 (fr) 2023-07-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP21773293.2A Pending EP4203889A1 (fr) 2020-08-28 2021-08-26 Dispositif de couplage pour un adaptateur pour un flacon, adaptateur pour un flacon, ensemble comprenant un tel adaptateur, et système comprenant un tel adaptateur

Country Status (5)

Country Link
US (1) US20240033182A1 (fr)
EP (1) EP4203889A1 (fr)
CN (1) CN115884743A (fr)
DE (1) DE102020210898A1 (fr)
WO (1) WO2022043446A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102022210211A1 (de) 2022-09-27 2024-03-28 B. Braun Melsungen Aktiengesellschaft Adaptervorrichtung zur Kopplung mit medizinischen Vials unterschiedlicher Größe
EP4389104A1 (fr) * 2022-12-19 2024-06-26 Presspart AG Dispositif de fermeture en plusieurs parties pour récipients de médicaments

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7425209B2 (en) 1998-09-15 2008-09-16 Baxter International Inc. Sliding reconstitution device for a diluent container
DE20016945U1 (de) 2000-09-30 2002-02-14 Braun Melsungen Ag Entnahmespike
US6875205B2 (en) * 2002-02-08 2005-04-05 Alaris Medical Systems, Inc. Vial adapter having a needle-free valve for use with vial closures of different sizes
US8523838B2 (en) 2008-12-15 2013-09-03 Carmel Pharma Ab Connector device
JP5829608B2 (ja) 2009-07-29 2015-12-09 アイシーユー・メディカル・インコーポレーテッド 流体移行デバイスおよびその使用方法
WO2013177628A1 (fr) * 2012-05-31 2013-12-05 Noble House Group Pty. Ltd. Port d'échantillonnage
BR112015010886A2 (pt) 2012-12-17 2017-07-11 Unitract Syringe Pty Ltd adaptadores de frasco
WO2016152801A1 (fr) * 2015-03-23 2016-09-29 株式会社ジェイ・エム・エス Adaptateur
AU2016323793B2 (en) 2015-09-17 2021-03-11 J&J SOLUTIONS, INC. d/b/a Corvida Medical Medicament vial assembly

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Publication number Publication date
US20240033182A1 (en) 2024-02-01
WO2022043446A1 (fr) 2022-03-03
CN115884743A (zh) 2023-03-31
DE102020210898A1 (de) 2022-03-03

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