Transfer device with opening cover

Abstract

The present invention relates to a transfer device for transferring a medium, comprising a transfer unit (38) having a first lumen (54) with a first opening (58) for guiding the medium, and a second lumen (52) with a second opening (56) spaced less than the first opening from a distal end (60) of the transfer unit, and a cover (64) extending therethrough that is spaced from the first opening (58) and intersected by a longitudinal axis (55) of the first lumen (54) with the first opening. A restraining member (98) extends between the cover (64) and the first lumen (54) for keeping container closure material away from the first opening when pierced by the transfer unit (38).

Description

[Technical Field]

[0001] The present invention relates to a transfer device for transporting, such as supplying or discharging, a medium such as a liquid, and includes a transfer unit having a first lumen with a first opening for guiding the medium, and a second lumen for pressure balancing, having a second opening that is spaced from the tip of the transfer unit by a smaller distance than the first opening, and a cover extends from the transfer unit at a distance from the first opening, or a section thereof, and is intersected by the longitudinal axis of the first lumen with the first opening. [Background technology]

[0002] Transfer devices for pharmaceutical preparations, called transfer devices in the October 2013 edition of DIN EN ISO 22413, are used to transfer liquids from one container to another. Transfer devices mix liquids or dissolve dry substances and can be used in combination with infusion or injection containers.

[0003] When the term transfer device is used, it can be replaced with the term transfer instrument or transport instrument.

[0004] Transfer devices can be found, for example, in EP 1 329 210 B1 (non-vented two-part transfer device), EP 1 498 097 B1 (two-part transfer device vented on the solvent side), WO 2018 / 111970 A2 (simple one-part transfer device) or DE 1 822 605 U (vented one-part transfer device).

[0005] Two-part transfer devices are often used to reconstitute powdered pharmaceuticals in pharmaceutical vials under negative pressure. Protein-based pharmaceuticals are an example. Because these pharmaceuticals are very sensitive and prone to denaturation, moisture is removed by freeze-drying, also known as lyophilization, to extend their shelf life. This process generates negative pressure within the pharmaceutical vial. In reconstitution using a non-vented two-part transfer device, the negative pressure within the pharmaceutical vial draws liquid from the solvent vial. In this step, the solvent vial is first mated with the first adapter of the transfer device, then rotated 180° and the other adapter is mated with the pharmaceutical vial. Due to the negative pressure within the pharmaceutical vial, liquid is drawn from the other vial. This process continues until pressure equilibrium is achieved.

[0006] However, in some cases, the negative pressure in one drug vial is not sufficient to completely aspirate the liquid from the other vial. Therefore, two-part transfer devices are known that are vented on the solvent side, whereby a separate lumen on the liquid side establishes a connection with the environment, so that the solvent side never experiences negative pressure during transfer, but always experiences ambient pressure. This results in the entire solution being aspirated.

[0007] However, in a corresponding two-part transfer device with two lumens on the solvent side, there is a risk that an air short circuit will occur between the openings of the respective lumens, leading to full or partial pressure equilibrium between the vials, which will prevent or prevent complete aspirating of the liquid. The usual solution to avoid this is to position the upper openings of both lumens at a clear distance from each other along the axis. However, this has the disadvantage that the transfer device must be made significantly longer and thicker to provide stability, which in turn can lead to the disadvantage that in actual application the vial stopper can be pushed into the vial when inserted, preventing transfer.

[0008] In addition to two-part transfer devices, one-part transfer devices (e.g., so-called vial adapters, collection spikes) are also known. Simple one-part transfer devices are used to deliver liquid or powdered medication to a vial by means of a syringe filled with a solvent. When the reconstituted medication is subsequently collected by the syringe, an increasing negative pressure is generated in the vial as the collection proceeds, which in turn leads to an increasing force, the so-called suction force, on the operating part of the syringe. Vented one-part transfer devices prevent this increase in suction force by pressure equilibration with the surroundings.

[0009] A transfer device of the type mentioned at the outset is known from US Patent Application Publication No. 2015 / 0083950 A1.

[0010] From EP 2512399 B1 it is possible to read of a transfer device having two lumens, one lumen for the transport of liquids and the other lumen for ventilation, the use of which is defined. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] European Patent No. 1329210B1 [Patent Document 2] European Patent No. 1498097B1 [Patent Document 3] International Patent Application Publication No. 2018 / 111970A2 [Patent Document 4] German Utility Model Application Publication No. 1822605U [Patent Document 5] US Patent Application Publication No. 2015 / 0083950A1 [Patent Document 6] European Patent No. 2512399B1 [Non-patent literature]

[0012] [Non-Patent Document 1] DIN EN ISO22413 October 2013 edition Summary of the Invention

[0013] The object of the present invention is to improve a transfer device of the type mentioned at the beginning so that, when used to transfer a liquid, pressure balancing occurs without the possibility of air short circuits occurring, while at the same time allowing for a compact design, while preferably ensuring that the throughflow of the liquid is not impeded.

[0014] Yet another aspect is considered in applications of transfer devices where liquid should be transferred conservatively through the transfer device into a vial containing a drug, while at the same time contact between the transfer device and the dissolved drug should be kept as minimal as possible.

[0015] To solve at least one of these aspects, the present invention contemplates that a restraining member extends between the cover and the first lumen, in particular between the edge surrounding the first opening of the first lumen or the wall surrounding the first lumen or the bottom wall of the transfer device and the first lumen, which keeps the material of the closure of the container, which is penetrated by the transfer unit, away from the first opening.

[0016] In accordance with the teachings of the present invention, one of the openings is covered at a distance from the other, so that no direct flow path is provided between the respective openings, but rather the flow must bypass the cover, thereby avoiding short circuits.

[0017] The cover is roof-shaped.

[0018] Such short circuits could possibly be avoided even if the spacing between the respective openings were relatively large, which is not necessarily required based on the teachings of the present invention, which would result in a short design height of the transfer unit in the axial direction of the transfer device, and consequently reduced contact with the dissolved drug compared to the prior art.

[0019] The possible short length of the transfer unit also offers another advantage: if the transfer device has a circumferential wall that accommodates the vial, the edge of the circumferential wall can extend circumferentially over the tip of the transfer unit, thereby eliminating or significantly reducing the risk of injury to the user. In contrast, in the prior art, as can be seen, for example, in EP 3463250 B1 and EP 2512399 B1, the tip of the transfer unit extends in a plane that extends through the edge of the circumferential wall.

[0020] The transfer device according to the invention may be a two-part transfer tool vented on the solvent side, which ensures that the compact, short, and thin design of the transfer unit not only prevents vial stoppers from being pushed in, but also avoids air short circuits. Ideally, the transfer unit is made compact and short enough to be located inside a housing arranged cylindrically around the transfer unit, thereby protecting it from contact by the user and thus preventing contamination. Furthermore, such a compact design with an enclosing housing simultaneously embodies centering of the transfer unit relative to the stoppers, so that the stoppers are inserted centrally or nearly centrally, where they are thinnest, minimizing the risk of push-in.

[0021] The transfer device according to the present invention may be a ventilated one-piece transfer device, which, due to the compact, short, and thin design of the transfer unit, not only prevents the vial stopper from being pushed in, but also ensures that the transfer unit does not sink into the dissolved drug, thereby minimizing contact between the dissolved drug and the transfer device. Furthermore, the transfer unit allows for the safe reconstitution of particularly sensitive lyophilized proteins, since the solvent is directed laterally against the vial wall, avoiding direct spraying of the solvent onto the powder. This safe introduction reduces denaturation and the foam formation often associated with it, and allows for shorter reconstitution times. This is particularly advantageous, especially for emergency medications.

[0022] In particular, the transfer unit is a cannula-like body having a tip, and the distance A from the first opening to the tip is different from the distance B from another second opening of another second lumen to the tip, in particular A>B, and preferably the second lumen is intended to be connected with the environment by means of a second opening, optionally via a filter, or to be connected with one or more internal spaces of a vial in the case of a two-lumen double-ended transfer device.

[0023] In this way, the distance from the second opening to the bottom wall of the transfer device is greater than the distance from the first opening to the bottom wall.

[0024] The cover extending at a distance from the first opening is preferably configured to have a first section having a first side and transitioning to a tip portion, and a second section extending from the first section and having a second side, each first side forming an angle α with the longitudinal axis of the body, and each second side forming an angle β with the longitudinal axis, with α<β.

[0025] The second section may then be intended to merge into a third section of the cover, which has two third sides that form a reflex angle with the second sides.

[0026] Preferably, the invention proposes that the first, second and third sections are delimited on the side located away from the second lumen by a frontal region consisting of a first end-face region on the distal side, with first edges extending parallel or approximately parallel to the distal end and spaced apart from one another, combined with a second end-face region of a first equilateral trapezoid geometry merging into a first side surface and / or a third end-face region of a second equilateral trapezoid geometry merging into a third side surface, the longer base of which coincides with or is adjacent to the longer base of the second end-face region.

[0027] Starting from the third section, a web-like section bounding a free space or passage opening for the medium to be transported then extends as a restricting element, this section preferably having the geometry of a third equilateral trapezoid, the shorter base of which preferably corresponds to the shorter base of the third end face region or is a section thereof or merges into this.

[0028] This web has the advantage in particular that when the closure is punctured, material is pushed into the intermediate space between the cover and the opening in the edge surrounding the first lumen, so that the opening is not at least partially closed.According to the invention, a spacer, such as a web, extends between the cover and the first lumen, in particular the edge surrounding the first opening of the first lumen, or the wall or bottom wall surrounding the first lumen, and is intended to prevent the closure of the vial, which is punctured by the transfer member, from penetrating the intermediate space between the first opening and the cover, or to prevent closure of the first opening to such an extent that it cannot occur.

[0029] The web-like section is preferably a section that transitions into a partial annular section on the bottom side of the transfer unit, or may be a section thereof.

[0030] The free edge of the partial annular section extending toward the tip side can be spaced apart from the third section to form a free space, the free space being bounded by the long side edge of the web-like section, the partial annular section, and the inner long wall section of the transfer unit.

[0031] The long wall section then merges into a transfer unit wall which surrounds, at least in partial areas, the first lumen on the one hand and the second lumen on the other hand.

[0032] Regardless, it is intended that each section of the cover be configured to be generally symmetrical about a plane in which the distal end and the longitudinal axis of the first opening of the first lumen lie.

[0033] The first end face region can then have an outer surface that extends convexly starting from the tip and symmetrically relative to this plane.

[0034] In particular, the third aspects are intended to transition from one another.

[0035] The third side faces, which then merge into one another, act as lateral guides for the media when the media are fed through the transfer device.

[0036] The configuration of the third aspect in this regard ensures that when liquid is guided through the transfer device into the vial containing the drug to be dissolved, the liquid is guided laterally away through the third aspect towards the side wall of the vial, where it flows downward before striking a plane extending through the drug approximately perpendicularly, thereby substantially avoiding bubble formation. In this way, conservative reconstitution is possible.

[0037] To ensure sufficient stability, starting from the cannula-shaped body on the bottom side, i.e. starting from the transfer unit, radially extending webs can extend which protrude from the bottom wall.

[0038] In the bottom area of ​​the transfer unit, and in particular delimited by the bottom wall, at least one opening, preferably two openings, extend, which or these are connected to a second lumen, through which air, for example ambient air, can be supplied to the emptied vial for pressure balancing.

[0039] The design of the transfer unit according to the present invention, in which the first opening has a larger distance from the distal end of the transfer unit than the second opening, and which includes a cover and a restricting member, can also be applied to a two-lumen double-ended transfer device, in which both ends of the two-lumen double-ended transfer device or only one of the ends of the transfer device can have a corresponding design for the cover and restricting member.

[0040] Further details, advantages and features of the invention will become apparent from the claims and the features that can be read therefrom - both by themselves and / or in combination - as well as from the examples that can be read from the following description of the drawings. [Brief explanation of the drawings]

[0041] [Figure 1] FIG. 2 is a partial cross-sectional view of a transfer device. [Figure 2] FIG. 2 is a plan view showing an insert of the transfer device of FIG. 1. [Figure 3] 3 is a perspective view and an enlarged reproduction of the insert of FIG. 2. FIG. [Figure 4] FIG. 3 is a cross-sectional view taken along line FF in FIG. 2. [Figure 5] FIG. 3 is a cross-sectional view taken along the line HH in FIG. 2. [Figure 6] FIG. 2 is a side view showing the transfer unit from diagonally above. [Figure 7] FIG. [Figure 8] FIG. 1 shows the transfer unit from below towards the front. [Figure 9] 1 is a principle diagram of a transfer unit according to the present invention; [Figure 10] FIG. 1 is a diagram illustrating the principle of flow transition. [Figure 11] FIG. 1 is a diagram illustrating the principle of flow transition. [Figure 12] 1 is a principle diagram of an insert of a transfer unit according to the present invention; [Figure 13] 1 is a principle diagram of an insert of a transfer unit according to the present invention; [Figure 14] 1 is a principle diagram of an insert of a transfer unit according to the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0042] 1-11, the teachings of the present invention are directed to a double lumen mechanism of a transfer apparatus or device, referred to as a transfer instrument, which allows for reconstitution of a drug by negative or positive pressure, particularly by negative pressure.

[0043] A transfer device 10 suitable for this purpose can be seen in Figure 1 and its structure corresponds to that of EP 3240520 B1, the disclosure of which is expressly incorporated by reference, the disclosure of which is hereby incorporated by reference.

[0044] The teachings of the present invention are suitable for any transfer device, such as that of EP 3454818 B1, in which a liquid or pharmaceutical solution is transferred from one container, such as a vial or syringe body, to another.

[0045] However, the teachings of the present invention are also intended for use in transfer devices that can be derived from other prior art, such as the prior art mentioned at the outset. In this case, the double lumen, as is known per se, is improved to eliminate short-circuiting between the lumens during proper operation, thus ensuring sufficient pressure balance for transferring a medium from one container to another by negative pressure or for injecting a medium into a container by pressure, since one of the lumens ensures the necessary pressure balance to ensure proper transfer. At the same time, it is ensured that the opening of the lumen through which the liquid is transferred cannot be blocked by the material of the closure to be punctured, such as the stopper of a container such as a vial.

[0046] In FIG. 1, a mixing or transfer device 10 according to the invention is shown purely in principle.

[0047] The transfer device 10 comprises two adapters 12, 14 connected to each other by a threaded connection. The adapters 12, 14 serve to accommodate containers, also called vials (not shown), whose contents are to be mixed together. In particular, one vial contains a medical substance, particularly in the form of a lyophilisate, while the other vial contains a liquid. The lyophilisate is under negative pressure, so that when a connection is established between the vials, the liquid from one vial is sucked into the vial containing the lyophilisate, thus allowing the reconstitution of the drug.

[0048] In the illustration of FIG. 1, adapter 12 serves to accommodate a vial containing a liquid, and adapter 14 serves to accommodate a vial containing a medical substance.

[0049] The adapters 12, 14 each have a hollow cylindrical outer body 16, 18, referred to as a housing, which in this embodiment is closed at its circumferential side and may be made of a shape-stable plastic, thereby providing shape stability.

[0050] Although the drawings show each outer body 16, 18 configured as a hollow cylinder, other shapes are possible, such as polygonal prismatic geometries.

[0051] Each outer body 16, 18 has an intermediate wall 24, 26 extending perpendicular to the longitudinal axis of the adapter 12, 14. Inserts 34, 36, each having a bottom wall 25, 27 and a peripheral wall 35, 37, are inserted into the space between the respective intermediate wall 24, 26 and the peripheral wall 30, 32 of the outer body 16, 18. Extending from each bottom wall 25, 27 toward the opening of the respective insert 34, 36, is a transfer unit 38, 40, also commonly referred to as a cannula body or spike. Transfer unit 38, hereinafter referred to as spike, is constructed in accordance with the teachings of the present invention, i.e., spike 38 has two lumens, one of which is connected to the environment, optionally via a filter, to allow pressure equilibration. In contrast, spike 40, which penetrates into a vial filled with a drug to be reconstituted in accordance with the above description, has a single lumen, as can be seen from the drawing figures.

[0052] Starting from the intermediate walls 24, 26 facing away from the inserts extend hollow cylindrical bodies 41, 42 which engage sealingly with one another when the adapters 12, 14 are screwed together and which are configured in particular as luer locks.

[0053] A filter may be provided between the inserts 34, 36, i.e. between their bottom walls 25, 27 and intermediate walls 24, 26.

[0054] Furthermore, the inserts 34, 36 may have inwardly projecting locking projections for rearwardly engaging the edge regions of the vials and thereby ensuring fixation in the respective adapters 12, 14. The locking projections are not shown in the drawings for reasons of clarity.

[0055] The circumferential walls 35,37 of the inserts 34,36 are at least locally spaced from the inner walls of the outer bodies 16,18.

[0056] Furthermore, the inserts 34, 36 are made of a softer material than the outer bodies 16, 18. The spacing between the outer bodies 16, 18 and the inserts 34, 36 provides a decoupling effect.

[0057] When a drug is reconstituted using negative pressure, a vial containing a solvent is first inserted into the upper adapter 12 shown in the drawing and secured in place by the elastic protrusions, and then the transfer device 10 is rotated 180° to fit the adapter 14 onto the drug vial under negative pressure.

[0058] Since the solvent vial is at approximately ambient pressure, after the connection between the respective vials is established, the liquid is drawn in due to the negative pressure that is generated in the drug vial.

[0059] If the spike 38 only had one lumen, the liquid transfer, and therefore the aspiration, would cease when the pressures in the respective vials were equalized. If the negative pressure in the drug vial was not high enough, the pressure equilibrium would be reached before the liquid transfer was complete. To prevent this, the lumen is connected to the surroundings, allowing the liquid to be transferred to a sufficient extent, since no negative pressure is created in the liquid vial during aspiration.

[0060] The spike 38 extends from the bottom wall 25 of the insert 34 and has a lumen 52, referred to as the secondary lumen, connected to the surroundings, and a lumen 54, referred to as the primary lumen, through which a liquid such as a solvent can flow when the spike 38 penetrates the stopper of a drug vial that is fitted to the insert 34 and is under negative pressure when the spike 40 penetrates the stopper. To this end, the vial is secured within the inserts 38, 40 by the projections.

[0061] As can be seen from the representation in the drawing, the opening 56, referred to as the second opening, of the second lumen 52, which allows for pressure balancing, extends at a greater distance from the bottom wall 25 than the opening 58, referred to as the first opening, of the first lumen 54.

[0062] The tip 60 of the spike 38 extends at a distance from the opening 56 of the second lumen 52, thereby piercing the stopper of the vial. The special shape of the spike 38 allows for puncturing with a point-like load, while at the same time ensuring to a sufficient extent that the cross-sectional expansion of the spike 38 further splits the stopper to be pierced during the subsequent penetration of the spike, and the shape of the outer surface of the spike 38 ensures a light action. In particular, the stopper is intended to split circumferentially in the region of the opening 58 of the first lumen 54, allowing liquid to be drawn into the drug vial without or nearly without flow resistance due to the stopper. At the same time, the stopper or its material ensures that the first opening 58 cannot be blocked or cannot be blocked in such a way that liquid transfer is prevented, as will be explained later.

[0063] Furthermore, in accordance with the teachings of the present invention, short circuits between the openings 56, 58 of the lumens 52, 54 are prevented, ie, air cannot be drawn directly into the first lumen 54.

[0064] These advantages are achieved by having the opening 58 of the first lumen 54 extend through the spike 38 such that a cover 64, which is a section of the body of the spike 38, is provided above it. Here, the cover 64 has an outer geometry that includes a section that extends to the tip 40 of the spike 38 to enable the point-like opening of the vial closure and its rupture to achieve the advantages described above. The cover 64 is intersected by the longitudinal axis 55 of the first lumen 54 and extends generally parallel to the bottom wall 25 of the insert 34, such that the projection of the first opening 58 along the longitudinal axis extends into the interior of the cover 64.

[0065] The structure of the spike 38 will be explained purely in principle with reference to Figure 9. In the following figures, the configurations that should be emphasized will be explained.

[0066] In FIG. 9, the bottom wall 25 of the insert 34 is reproduced in purely principle with the spikes 34 extending from the bottom wall 25 .

[0067] The spike 38 has a base section 39 extending from the base wall 25 that tapers toward the body 61 of the spike 34. Within the base section 39 are passages 43, 44 that connect the second lumen 52 with the surroundings.

[0068] As is clear from the perspective view of Figure 9a, a cover 64, in particular of roof-shaped geometry, extends at a distance relative to the first opening 58, i.e. the opening of the first lumen 54 through which the connection with the spike 40 is made via the mutually engaging luer connections 41, 42, and which ensures that the air entering via the second lumen 52 cannot flow directly into the first opening 58, i.e. no short circuit occurs, but rather the air is diverted so that the liquid contained in the vial contained in the first adapter 12 can be drawn out to the required extent via the first lumen 54.

[0069] 9b shows a plan view of the bottom wall 25 with the spikes 38. A bottom section 39 extending from the bottom wall 25 can be seen, with passage-like openings 43, 44 connected to the second lumen 52.

[0070] Cross section AA can be seen in Figure 9c, which again clearly shows the bottom wall 25 with spike 38, the first and second lumens 54, 52 with openings 58, 56, and the cover 64. This view also clearly shows that the second opening 56 has a smaller spacing relative to the tip 60 of the spike 38 than the first opening 58 of the first lumen 54.

[0071] The ratio of the spacing of the first openings 58 of the first lumen 54 to the distal end 60 to the spacing of the second openings 56 to the distal end 60 is preferably 3:1 to 2:1, in particular 2.4:1, i.e., the spacing of the first openings 58 to the distal end 60 is, for example, two to three times greater than the spacing of the second openings to the distal end 60. Here, the edge regions of the corresponding openings 56, 58 located furthest from the distal end 60 are considered. In FIG. 4, this would be the region 57 of the second openings 56 and the region 53 of the first openings 58.

[0072] 6 to 8, a preferred form of spike 38 having a cover 64 is described which ensures that unwanted short circuits to vials containing liquids are essentially eliminated if the closure is pierced by spike 38 when air is aspirated.

[0073] Spike 38 has, in the area covering first lumen 54 or its opening 58, a first region or section 66 transitioning into tip 60 having first sides 68, 70, which transition into second sections 72 having second sides 74, 76, the first sides 68, 70 of each first section 66 forming an angle α with the longitudinal axis of spike 38, i.e., with its body, and the second sides 74, 76 of each second section 72 forming an angle β with the longitudinal axis, where α is less than β. In particular, first sides 68, 70 extend generally parallel to each other and to the longitudinal axis of spike 38.

[0074] The second section 72 merges into a third section 78, which has side surfaces 80, 82 that face towards the opening 58 of the first lumen 54 and have a so-called convex geometry or curvature relative to it, which may be configured in each section as is clear in principle from the drawings. These sections, when viewed in the direction of the side surfaces 74, 76, form a V-shaped geometry in cross section.

[0075] This portion of spike 38, consisting of first, second, and third regions 66, 72, and 78, is collectively referred to as cover 64 for first opening 58, although third sides 80, 82 do not actually cover first opening 58. Regions or areas 66, 72, and 78 are configured in the portion of spike body 61 through which first lumen 54 extends.

[0076] The first lumen 54 is surrounded circumferentially and in a section by the part-annular wall of the spike body 61 having an outer surface 84. It is followed by a partition surface 88 of the spike body, extending parallel to the longitudinal axis of the spike 38, which delimits a section 90 of the spike body 61, into which the second lumen 52 having the opening 56 extends.

[0077] The partial annular region 86 extends with its distally extending edge 92 in a spaced relationship to the third sides 80, 82, thereby forming two openings 94, 96 separated by a web 98 that originates at the partial annular body 86 and extends to the third region 78, as particularly shown in Figure 7. The web 98 has a trapezoidal geometry in plan view, with its shorter base merging into or becoming the third region 78.

[0078] The web 98 provides an inventive feature of the transfer device that should be emphasized.

[0079] Due to the compact design of the transfer unit, i.e. of the spike 38, the first opening 58 of the first lumen 54 may be located near the area of ​​the bottom surface 25. When the spike 38 pierces a closure, such as a rubber stopper, there would be a risk, without the web 98, that the closure material would seep into the intermediate space between the cover 64 and the first opening 58 to such an extent that it would at least partially close the intermediate space. The web 98 ensures that the closure material is kept away from the first opening 58, so that liquid can be aspirated to the required extent via the passage openings 94, 96 and the first opening 58.

[0080] As can be seen in particular in Figures 6 to 8, the first side surfaces 68, 70 merge into a first end surface region 100, which is rectangular in part and extends up to the tip 60 of the spike 38, the second side surfaces 74, 76 merge into the following second end surface region 102, which has an equilateral trapezoidal geometry, and the third side surfaces 80, 82 merge into a third end surface region 104, which also has an equilateral trapezoidal geometry, with the longer base of the second end surface region 102 and the longer base of the third end surface region 104 coinciding or merging into each other.

[0081] To avoid air short-circuiting between the openings 56, 58 and to balance the respective capillary forces, the air outlet opening 56 is located near the tip 60 of the spike 38, thereby simultaneously limiting the angle of the tip 60.

[0082] The geometry of the spike body 61 above the first opening 58 of the first lumen 54 ensures that, when piercing the vial closure, an initial, approximately point-like load is applied, thereby requiring low force consumption. This is achieved in particular by the first region or area 66, which has parallel or substantially parallel lateral faces 68, 70 extending from the tip 60, and by the outwardly convex end region 60. The first region or area 66 is then delimited by surfaces that extend parallel to the longitudinal axis of the spike 38 and are subdivided by the first area 66, with the surface areas 69, 71 extending in a common plane that also extends parallel to the longitudinal axis of the spike 38 and that preferably intersects with the tip 60. The surface sections 69 , 71 delimit the sections of the spike 38 that extend in a modified manner relative to the first lumen 54 and extend around the second lumen 52 .

[0083] In the ensuing process, the tip region is expanded by the second sides 74,76 to a maximum width at the transition between the second and third sides 74,76 to 80,82, thereby allowing the closure to be split to the desired extent.

[0084] The spike body 61 then extends almost constantly in cross section in the region of the web 98 and the annular section 86, which allows a reliable sliding of the closure along the spike body 61. In this way, the closure can abut to a sufficient extent against the region of the annular section 86, so that the openings 94, 96 are not covered for the passage of the solvent, and thus suction through the first lumen 54 is guaranteed.

[0085] The cover 64 being larger than the first opening 58 in the third section 78 provides the additional benefit of preventing the rubber particles of the closure from being punched out by the edge of the first lumen 54 .

[0086] The offset extension of the first and second sides 68, 70, 74, 76 toward the outer edges of the areas 69, 71 defining the width of the spike 38 reduces the load required to puncture the stopcock compared to a spike that does not have a corresponding reduction in cross-sectional area in the tip region.

[0087] A web 98 extending between openings 94, 96 and transitioning into third section 78 ensures that a closure surrounding spike 38 cannot block second opening 58. The tapering of web 98 from annular section 86 to the cover ensures that openings 94, 96 are wide enough to allow fluid to flow into first lumen 54.

[0088] This is reinforced in particular by the fact that the tip 60 of the spike 38 extends eccentrically within the insert 35, ie at a distance relative to its longitudinal axis 63, as can be seen in principle from FIG.

[0089] The height of the liquid inlet opening 58 is determined by the need for a minimum residual volume for the various vial and closure members, and by the optimum spacing of the openings 56 to allow a pressure equilibrium, allowing a sufficiently large pressure difference to be generated. This allows the capillary forces of the air-permeable lumen 52, which are high compared to the liquid-permeable lumen 54, to be reduced, thus avoiding or reducing to an acceptable extent the inflow of liquid into the second lumen 52.

[0090] The second and third sides 74, 76, 80, 82, and the maximum width of the spike body 61 extend above the first opening 58 through the third section 78, minimizing the risk of air bypass or short circuit.

[0091] In other words, the projection of the first opening 58 in the longitudinal direction of the first lumen 54 is smaller than the plane of the third side surfaces 80, 82 that extend above and face the first opening 58. In the corresponding projection, the first opening 58 is located entirely within the third side surfaces 80, 82.

[0092] The third side surfaces 80, 82, which merge into one another, i.e., form a closed surface, have a convex transition relative to the first opening 58, which further provides the advantage that when a transfer device having a spike 38 constructed according to the present invention is used to introduce liquid into a container by overpressure, i.e., when the tip 60 extends below the opening 58 corresponding to the liquid outlet opening, the liquid exiting the opening 58 hits the obliquely extending side surfaces 80, 82, and thus the liquid jet is redirected laterally onto the inner surface of the vial, so that the drug in the vial is not significantly disturbed and can therefore be dissolved in a safe manner.

[0093] When the dissolved drug is expelled from the vial by a transfer device having a spike 38 configured according to the present invention, the ejection force is significantly lower than that of the prior art due to the configuration of the spike according to the present invention.

[0094] 2 to 5 again show various views or cross sections of the insert 35, illustrating the configuration of the spike 38 according to the invention in order to provide a clear understanding of the same. In particular, cross sections FF and HH also show that the tip 60 of the spike 38 extends recessed, i.e., offset toward the bottom wall 25, relative to the plane 135 extending through the upper edge of the circumferential wall 35 of the insert 34. In this way, the tip 60 does not protrude from the insert 34, thereby minimizing the risk of injury to the user. The risk of contamination is also reduced.

[0095] In particular, the perspective view of FIG. 3 again shows the distinctive feature of the cover 64 extending in spaced relation above the first opening 58 of the first lumen 54 .

[0096] Furthermore, it can be seen that the circumferential wall 35 has cutouts, two of which are designated by the reference numerals 48 and 50. In the region of the cutouts 48 and 50 extend projections (not shown) which penetrate into the interior of the insert 34 and which engage and fix the edge of the vial in a rearward manner.

[0097] It can further be seen that the intermediate wall 25 transitions into the circumferential wall 35 via a circumferential step 125 or step on which the edge of the vial rests, thereby leaving uncovered the passage-like openings 43, 44 that establish a connection between the second lumen 52 and the ambient air. This is one feature of the present invention. Naturally, the number of connections to the second lumen 52 may be more or less than two.

[0098] The eccentric extension of the tip 60 allows the circumferential surface of the spike 38, which extends at a distance from the liquid passage openings 94, 96, to extend closer to the longitudinal axis 63 of the adapter 12 compared to a configuration in which the tip is centrally located, i.e., pierced by the longitudinal axis 63. In this way, a larger space or cross-sectional area is provided in the region of the passage openings 94, 96 for the stopper material to be pierced, so that the stopper material can slide along the circumferential surface of the spike 38 without blocking the openings 94, 96.

[0099] The roof-shaped cover 64 forms a flow resistance for the liquid flowing in the direction of the bottom wall 25, and due to the roof-shaped embodiment expanding in the direction of the bottom wall 25, i.e. due to the asymmetrical conical cross-sectional expansion caused by the cover 64 from the tip 60 in the direction of the bottom wall 25, the liquid is redirected so that it does not flow, as it were, parallel to the longitudinal axis 55 of the first lumen 54. This liquid is the liquid that is in the vial whose closure is perforated by the spike 38.

[0100] The influence on the flow behavior will be explained purely in principle with reference to Figures 10 and 11. In Figure 10, the main flow line of the liquid is represented by the reference numeral 110, and there is no cover on the first opening 58 of the first lumen 54.

[0101] The main flow line of air into the vial, supplied through the second lumen 52, is designated 112. The distance between each of the main flow lines 110, 112 is designated a.

[0102] When the cover 64 according to the present invention is spaced apart from the first opening 58 of the first lumen 54 and liquid enters the intermediate space between the cover 64 and the first opening 58 through the openings 94, 96 and is aspirated by the negative pressure present in the second vial, the main flow line 114 of the aspirated liquid extends further away from the spike 38, resulting in a distance b between the main flow line 112 of the aspirated air and the main flow line 114 of the liquid, where b > a, as is apparent from FIGS. 10 and 11 . The deflection of the aspirated liquid becomes more pronounced the faster the liquid flows or is transported, and the wider the distance b. There is no corresponding effect on the aspirated air. This is important because the air exiting the second opening is more likely to be drawn in the opposite direction to its natural upward movement the narrower the distance a to b. In this manner, due to the roof-shaped geometry of the cover 64, a short circuit between the second opening 56 of the second lumen 52 and the first opening 58 of the first lumen 54 is prevented or reduced to a sufficient extent that the spike 38 can sufficiently aspirate the liquid in the vial into which it extends.

[0103] The distance between the first opening 58 and the cover 64, i.e., the plane pierced by the longitudinal axis 55 of the first lumen, located at the intersection of the sides 80, 82 of the third section 78, is preferably 2 to 3 mm, in particular 2.5 mm, or about 2.5 mm. Starting from this intersection, the distance between the sides 80, 82 of the first opening 58 increases as explained above.

[0104] With reference to Figures 12 to 14, an embodiment of the transfer unit according to the invention will be described purely in principle. Figures 12 and 13 correspond to the basic structure and application of the embodiment described above, in which a container called vial 2 in Figure 12 contains a medical substance, and via a transfer unit 38 according to the invention, preferably of the design described above, and a transfer unit 40, via which vial 2 is connected to vial 1 containing a liquid. Then, due to the negative pressure generated in vial 2, the liquid in vial 1 is sucked out via transfer units 40 and 38. In Figure 12, transfer unit 38 is connected to the ambient air via at least one opening 43 and 44, as described above.

[0105] The only difference between FIG. 13 and FIG. 12 is that the ambient air flowing into the vial 1 via the transfer unit 38 flows through a filter 144 beforehand, thereby providing sterile ventilation.

[0106] Figure 14 is intended to clarify that vials 1 and 2 are connected to one another via a two-lumen double-ended transfer device. The transfer unit has two lumens. In the central region of the transfer unit, an operating part extends to enable the tip of the transfer device to puncture the stoppers of vials 1 and 2. The operating part simultaneously forms an entry limiter.

[0107] At least one end region of the double-ended transfer device is configured according to the transfer unit 38, i.e., the opening with a large distance to the tip of the transfer unit, corresponding to the first opening 58, is provided with a cover. There is also a restricting element that ensures that the punctured closure cannot close the opening that extends closer to the operating part, i.e., the first opening 58 in Figs. 1 to 11.

[0108] The opposite end of the transfer unit also has two openings. Liquid is drawn out of vial 2 by the negative pressure created in vial 1 through a lumen whose opening is spaced farther from the tip of the double-ended cannula that extends into vial 2 than the opening of the second lumen.

[0109] As is typical for a two-lumen, double-ended transfer device, the openings of each lumen are spaced apart at each end of the transfer unit.

[0110] At one end of the double-ended transfer device, the opening of the first lumen extends at a greater distance from the distal end than the opening of the second lumen, and at the other end of the double-ended transfer device, the opening of the second lumen is spaced less from the distal end of the other end than the opening of the first lumen. The following is a summary of the claims as originally filed: [C1] A transfer device (10) for transferring, for example, supplying or discharging a medium such as a liquid, the transfer device comprising: a transfer unit (38) for guiding the medium, the transfer unit (38) having a first lumen (54) with a first opening (58) and a second lumen (52) with a second opening (56) spaced from a tip end (60) of the transfer unit at a distance smaller than the first opening; the transfer unit (38) preferably extending from a bottom wall (25) or an operating portion or an entry limiting portion; and a cover (64) extending from the transfer unit (38) or a section thereof, the cover (64) being intersected by a major axis (55) of the first lumen (54) with the first opening, the cover (64) extending at a distance from the first opening (58). a restraining member (98) extending between the cover (64) and the first lumen (54) for keeping container closure material punctured by the transfer unit (38) away from the first opening. [C2] A transfer device as described in C1, characterized in that the restraining member (98) extends between the cover (64) and an edge surrounding the first opening (58) of the first lumen (54), or between the cover (64) and a wall portion (84) surrounding the first lumen, or between the cover (64) and a wall portion (25) from which the transfer unit (38) extends. [C3] The transfer device described in C1, characterized in that the cover (64) has a first section (66) having first sides (68, 70) that transition to the tip (60) of the transfer unit (38), and a second section (72) that extends from the first sides and has second sides (74, 76), each of the first sides forming an angle α with respect to the longitudinal axis direction of the transfer unit (38), and each of the second sides forming an angle β with respect to the longitudinal axis, with α<β. [C4] A transfer device as described in any one of claims C1 to C3, characterized in that the second section (72) transitions into a third section (78) of the cover (64) having two third sides (80, 82) that form a reflex angle with the second sides (74, 76). [C5] A transfer device according to any one of claims C1 to C4, characterized in that the first, second and third sections (66, 72, 78) are delimited on the side located away from the second lumen (52) by a frontal region (100), which is composed of a first end-face region on the distal side that merges into the first side surface (68, 70) and / or a second end-face region (102) of a first equilateral trapezoid geometry that subsequently merges into the second side surface (74, 76) and / or a third end-face region (104) of a second equilateral trapezoid geometry that merges into the third side surface (80, 82), with the longer base of the third end-face region coinciding with or adjacent to the longer base of the second end-face region. [C6] A transfer device according to any one of claims C1 to C5, characterized in that starting from the third section (78) a web-like section delimiting a free space or passage opening (94, 96) for the medium to be transported extends as the restraining element (98), which preferably has the geometry of a third equilateral trapezoid, the shorter base of which is preferably the shorter base of the third end face region or is a section thereof or merges into it. [C7] A transfer device according to any one of claims C1 to C6, characterized in that the web-like section transitions into or is part of a partial annular section (86) on the bottom side of the transfer unit (38). [C8] A transfer device as described in at least C6, characterized in that the distally extending free edge of the partial annular section (86) is spaced apart from the third section (78) to form the free spaces (94, 96), each of the free spaces being bounded by a long side edge of the web-like section, the partial annular section, and an inner long wall section of the transfer unit (38). [C9] A transfer device according to any one of claims C1 to C8, characterized in that the long wall section transitions into a transfer unit wall that surrounds, at least in partial areas, the first lumen (54) on the one hand and the second lumen (52) on the other hand. [C10] A transfer device described in any one of C1 to C9, characterized in that the multiple sections of the cover (64) are configured symmetrically with respect to a plane on which the tip portion (60) and the longitudinal axis (55) of the first lumen are located. [C11] A transfer device according to at least C10, characterized in that the first end face region (100) has an outer surface that extends convexly symmetrically relative to the plane, starting from the tip (60). [C12] A transfer device according to any one of claims C1 to 11, characterized in that the transfer unit (38) extends from a bottom wall (25) of the transfer device (10), in particular of an insert (34), which bottom wall transitions via a step or stepped portion (125) to a circumferential wall (35) that accommodates a container supported on the opening side above the step or stepped portion, and the transfer unit has at least one opening (43) in the area of ​​the bottom wall, through which air can be sucked from the area of ​​the bottom wall into the second lumen (52). [C13] The transfer device according to any one of C1 to C12, wherein the third side surfaces (80, 82) merge into each other. [C14] A transfer device according to any one of claims C1 to C13, characterized in that the third side surfaces (80, 82) that merge into each other act as lateral guides for the medium in the case of a medium fed via a one-part transfer device. [C15] A transfer device as described in any one of C1 to C14, characterized in that the cover (64) has a guide surface extending at a distance from the first opening (58) and intersecting the longitudinal axis (55) of the first lumen (54), the guide surface having a convex transition with respect to surfaces (80, 82) extending perpendicular to the longitudinal axis. [C16] A transfer device described in any one of C1 to C15, characterized in that the projection of the first opening (58) in the longitudinal direction of the first lumen (54) extends upward from the first opening at a distance and is smaller than the surface (80, 82) of the cover facing the first opening. [C17] A transfer device as described in any one of C1 to C16, characterized in that the body (61) of the transfer unit (38) has a cross-section with an elliptical geometry on the bottom side, and / or the tip portion (60) of the transfer unit extends eccentrically with respect to the circumferential wall (35) surrounding the transfer unit (38). [C18] A transfer device according to any one of claims C1 to C17, characterized in that the length of the transfer unit (38) is smaller than the height of the circumferential wall (34) of the transfer device (10) that surrounds the transfer unit. [C19] A transfer device according to any one of claims C1 to C18, characterized in that the transfer unit is at least one end region of a two-lumen double-ended transfer device.

Claims

1. A transfer device (10) for transferring, such as supplying or discharging, a medium such as a liquid into or out of a container connected to the transfer device (10), comprising a transfer unit (38) for guiding the medium and having a first lumen (54) having a first opening (58) and a second lumen (52) having a second opening (56); the second opening has a smaller distance from the tip (60) of the transfer unit than the distance of the first opening from the tip (60); A transfer device comprising a cover (64) extending from the transfer unit (38) or a section of the transfer unit, the cover (64) being intersected by a longitudinal axis (55) of the first lumen (54) having the first opening, the cover (64) extending at a distance from the first opening (58), the second lumen (52) permits pressure equilibration with ambient air within the container; a restraining member (98) extending between the cover (64) and an edge surrounding the first opening (58) or the first lumen (54) to hold the material of the container closure punctured by the transfer unit (38) away from the first opening.

2. 2. The transfer device of claim 1, wherein the cover has a first section having a first side surface that transitions into the tip end of the transfer unit, and a second section extending from the first side surface and having a second side surface, each of the first side surfaces forming an angle α with respect to the longitudinal axis of the transfer unit, and each of the second side surfaces forming an angle β with respect to the longitudinal axis, with α<β.

3. 3. The transfer device of claim 2, wherein the second section (72) transitions into a third section (78) of the cover (64) having two third sides (80, 82) that form an oblique angle with the second sides (74, 76).

4. 4. The transfer device according to claim 3, wherein the first, second and third sections are delimited on the side located away from the second lumen by a first end-face region, which end-face region is composed of a distal first end-face region merging into the first side face (68, 70) and / or a second end-face region (102) of a first equilateral trapezoid geometry merging into the second side face (74, 76), and / or a third end-face region (104) of a second equilateral trapezoid geometry merging into the third side face (80, 82), with a longer base side coinciding with or adjacent to a longer base side of the second end-face region.

5. 4. The transfer device according to claim 3, wherein the restricting member (98) is a web-like section extending from the third section (78) and defining a free space or passage opening (94, 96) for the medium to be transported.

6. A transfer device as described in claim 5, characterized in that the restraining member has the geometry of a third equilateral trapezoid, the shorter base of which is the shorter base of the third end face region, or is a section thereof, or transitions into it.

7. 7. Transfer device according to claim 5 or 6, characterized in that the web-like section merges into or is part of a partial annular section (86) on the bottom side of the transfer unit (38).

8. 7. A transfer device according to claim 5 or 6, characterized in that the distally extending free edge of the partial annular section (86) is spaced apart from the third section (78) to form the free spaces (94, 96), each of the free spaces being bounded by a long side edge of the web-like section, the partial annular section and an inner long wall section of the transfer unit (38).

9. 9. Transfer device according to claim 8, characterized in that the long wall section merges into a transfer unit wall which surrounds, at least in partial areas, the first lumen (54) on the one hand and the second lumen (52) on the other hand.

10. 5. The transfer device according to claim 4, wherein the sections of the cover (64) are configured symmetrically with respect to a plane in which the tip (60) and the longitudinal axis (55) of the first lumen lie.

11. 11. Transfer device according to claim 10, characterized in that said first end face region (100) has an outer surface that extends convexly symmetrically relative to said plane, starting from said tip (60).

12. 2. A transfer device according to claim 1, characterized in that the transfer unit (38) starts from a bottom wall (25) of the insert (34) of the transfer device (10), the bottom wall transitioning via a step or a stepped section (125) to a circumferential wall (35) accommodating a container supported on the step or stepped section at its opening side, the transfer unit having at least one passage (43) in the area of ​​the bottom wall, through which air can be sucked from the area of ​​the bottom wall into the second lumen (52).

13. 4. Transfer device according to claim 3, characterized in that the third sides (80, 82) merge into one another.

14. 14. Transfer device according to claim 13, characterized in that the third sides (80, 82) that merge into one another act as lateral guides for the medium in the case of a medium fed via a one-part transfer device.

15. 4. The transfer device of claim 3, wherein a longitudinal projection of the first opening (58) of the first lumen (54) extends into the third section (78) of the cover (64).

16. 2. A transfer device according to claim 1, characterized in that the body (61) of the transfer unit (38) has a cross section with an elliptical geometry on the bottom side and / or the tip (60) of the transfer unit extends eccentrically with respect to a circumferential wall (35) surrounding the transfer unit (38).

17. 2. Transfer device according to claim 1, characterized in that the length of said transfer unit (38) is less than the height of the circumferential wall (34) of said transfer device (10) that surrounds said transfer unit.

18. 2. The transfer device of claim 1, wherein the transfer unit is at least one end region of a two-lumen, double-ended transfer device.

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