The present invention relates to a connector device for establishing fluid communication between a first container and a second container, allowing sterile mixing of the contents of said first container and said second container. More specifically the present invention relates to a connector device for establishing fluid communication between a first container and a second container, said connector device comprising a first tube member having a first end for engaging the first container, said connector device further comprising a second tube member joined with said first tube member at a first end, and having at a second end an engagement member for engagement of said second container, wherein said first tube member comprises a first piercing member adapted to pierce said first container to allow fluid flow from said first container into said first tube member, said first piercing member comprising a shaft extending from an proximal end of said piercing member towards a distal end of said first piercing member, and a pointed head arranged at said proximal end.

Generally, the present invention lies within the field of delivery of pharmaceutical solutions to patients. A very large number of different pharmaceutical compounds are administered to patients as solutions, typically by use of a flexible container containing the solution and being attached by tubes to an intravenous (IV) catheter. Some pharmaceutical solutions are provided as ready-for-use solutions, but very often, the pharmaceutical com- pound is provided in a solid form, typically as a sterile powder. Such powders have to be reconstituted in a diluent liquid before being administered to the patient. Different liquids may be used as diluents, very common ones are saline solutions, such as an isotonic potassium chloride solution, and dextrose solutions. The diluents are typically provided in a pre-filled sterile container, such as a flexible polymer container of the bag-type, which is very common in hospitals. The sterile powder or other pharmaceutical compound is typically provided in a small bottle commonly known as a vial. Sometimes the pharmaceutical compound is provided as a concentrate, which then has to be di- luted, rather than reconstituted, in the diluent.

In order to reconstitute the solid pharmaceutical compound it has to be brought into contact with the diluent. Since the final solution is typically to be administered intravenously to the patient, it is very important that the reconstitution is carried out without any risk of contamination of the diluent, solid or final solution. Typically, the solid in the vial can be reconstituted simply by allowing diluent to enter the vial and thereby allowing the diluent and solid to mix. Sometimes the mixing can be facilitated by either shaking the connected vial and diluent container or alternatively by pressing and releas- ing the diluent container to push diluent into the vial and create a current in the liquid.

After proper reconstitution of the solid in the diluent, the final solution is typically administered to a patient by mounting one end of a tube with a drip-chamber to the diluent container and attaching the other end to an IV catheter. The flow can optionally be controlled and monitored by an infusion pump. Often, however, the diluent container is simply placed above the patient, so that gravity will cause the solution to flow from the container to the patient. In such cases the flow can be controlled by use of a mechanically adjustable clamp attached to the tube.

As mentioned previously, it is of the utmost importance that the final solution, which is to be administered to a patient, remains sterile. Thus, it is very important that the equipment used to reconstitute the solid pharmaceutical compound minimizes any risk of contamination by either being easy to sterilise after use, and/or by being designed as disposable single-use items.

Furthermore, a large number of the pharmaceutical solids and resulting solutions used for IV therapy, such as chemotherapeutic agents, are toxic and potentially harmful to hospital personnel. Other substances for IV administration, such as antibiotics, may not be directly toxic, but may still be potentially harmful to the environment. It is therefore a requirement of hos- pital staff as well as authorities, that all possible measures should be taken to avoid spillage or leaks of the pharmaceutical solids and solutions. This obviously includes constructing the equipment used for reconstitution in a way that minimizes the risk of spillage and leaks.

A further requirement of hospital personnel, which is linked to reduc- ing the above risks, is that the equipment should be easy to use. Ease of use also implies that it should be made as hard as possible to misuse or damage the equipment in any way. One way to achieve ease of use is to design the equipment as disposable single-use items as this eliminates the task of sterilising equipment after use.

An additional requirement is that it should be clear from the equipment used for reconstitution that it has been used. This would reduce the risk of re-use of contaminated equipment. Also, it would help minimize the risk of the potentially very harmful situation where more than one vial of pharmaceutical compound is reconstituted in the same diluent, thus doubling the concentration of the final solution. To eliminate the problem of accidentally reusing contaminated equipment, many users require that the equipment is designed so that it is only technically possible to use it once.

Moreover, equipment designed for single-use is preferable in several usage situations, as this eliminates the risk of contamination following re- peated use or faulty sterilisation. A further advantage of single-use equipment is that it makes the equipment easier and faster to use since it eliminates the need for sterilisation. Nevertheless, a single-use design poses greater challenge to the supplier of the equipment, in order to make it economically sound.

As mentioned previously, it is known in the art to mix, reconstitute or dilute a pharmaceutical compound or composition in a diluent under sterile conditions. However, the prior art still generally fails to provide an optimal solution to the above mentioned problems and requirements. As a perfect illustration of this unmet need, hospital personnel as well as health authori- ties are currently demanding new and improved solutions to their problems within the area of making final solutions for IV administration. The currently available equipment fails to meet the combined requirements of e.g. ease of use, minimized risk of contamination, minimized risk of leaks, and thereby increase safety for the user.

EP-A-2043585 discloses a connector which generally fulfils the above requirements for use in reconstituting or diluting pharmaceuticals for intravenous administration. However, despite the fact that this connector generally fulfils the above requirements there is still room for improvement. One place where such an improvement could be desired, is in the construction of the means for retaining the diluent container. More specifically, in EP-A-2043585, the connector has a number of retaining elements at the end of a tube member, in EP-A-2043585 referred to as flanges arranged in a concentric manner around a loosely held piercing member for piecing the closure, e.g. through a rubber membrane, of the diluent container. The flanges comprise tabs adapted for engaging the neck of the first container. When the neck of the container is pushed into engagement with the end of the tube member, the flanges bend slightly outwardly, allowing the neck of the first container to pass the tabs and fully engage with the end of the tube member. When the broad part of the neck has passed the tabs, the flanges return to their normal position, whereby the tabs make it difficult to disengage the fluent container. The container can be further secured in the engagement with the connector by employing a locking ring, which may slide over the outside of the flanges once the fluent container is engaged, thus preventing the flanges from bending outwards, and thus pre- venting disengagement of the fluent container. Furthermore, the locking ring disclosed in EP-A-2043585 may be provided with an internal shoulder adapted to engage with a recess of each flange in the activated position of the locking ring. Thereby, the locking ring is locked in its activated position, so that the flanges cannot be bent radially outwards, and consequently so that the neck of the fluent container cannot be disconnected from the connector.

It will be understood that this construction with flanges allows only for connection with the one specific dimension of the neck of the diluent container, for which it is constructed, e.g. such as the rigid neck of a flexible diluent bag container. A diluent container with different neck dimensions cannot be retained, e.g. because the dimensions are too small for it to be retained, or because the dimensions are too big to allow insertion between the flanges.

It is an object of the invention to overcome this drawback, and pro- vide a connector device allowing the use of different necks of diluent containers with one and the same connector device.

According to a first aspect of the invention this object is achieved by a connector device according to the opening paragraph characterized in that the pointed head of said first piercing member comprises at least one rib and forming at least a first barb, that said shaft comprises an oblong slit extend- ing along said shaft between said proximal end and said distal end of said first piercing member, and that the shaft comprises a first arresting member, arresting said first piercing member in said first tube member.

By constructing the first piercing member of the connector device in this manner it becomes possible for the connector device to be attached to a wide variety of diluent containers with different types of closures, because the piercing member will be able to hold an attached container irrespective of the dimensions of the neck of the container, and even irrespective of whether a neck is present or not. At the same time the use of a slit with an oblong hole serves the dual purpose of increasing the flexibility of the shaft so as to facilitate insertion and engagement of the arresting member in the flow passage of the connector device, and serving as a flow passage for the diluent.

According to a first preferred embodiment, said rib comprises a first cut-out. This provides the rearmost part of the pointed head, as seen in the pointing direction, with increased flexibility thereby easing insertion through the closure of the container. Furthermore this flexibility allows a reduction in the size of the hole pierced in the closure, thus preventing an unnecessary large hole from being made.

According to another preferred embodiment, said rib comprises a generally triangular shape, said first cut-out being formed in a first side of said generally triangular shape and a further cut out being formed in a second side of generally triangular shape. This further increases the flexibility of the rearmost part of the pointed head, while still leaving a secondary barb for arresting the shaft in the fluid flow channel of the connector device.

According to a further preferred embodiment, the width of the pointed head at the barb is adapted to match approximately the external diameter of distal end of the external extension of the flow channel. This facilitates the penetration of the flow channel through the sealing member of the closure of the first container.

According to yet another embodiment, at least one further barb is provided along the shaft, said further barb being directed in the opposite direction with respect to said first barb. This further barb in conjunction with the first barb or the secondary barb arrests the shaft in the opposite direction of the latter, so as to arrest the shaft in both directions.

According to yet another preferred embodiment, said shaft has a non-circular cross-section. Using a non-circular cross-section facilitates the passage of the fluid into said oblong slit behind said pointed head, and in particular out of the oblong slit again into the fluid flow passage within the connector device.

This is in particular the case if according to a further preferred embodiment, the non-circular cross-section comprises two essentially flat opposite sides between which the oblong slit forms a through hole.

According to yet a further embodiment, the connector device is adapted for the attachment of a separate additional retaining member. This allows for additional optional securing of the connector device to the first container, in cases where such additional security may be required.

According to still a further embodiment, the first tube member comprises a second end for discharge of fluid from the device. This allows for attachment of an IV tube or a further connector device.

According to another preferred embodiment the second tube member comprises a second piercing member adapted to allow fluid communication from said second container between said first tube member and said second tube member. This allows mixing of the diluent of the first container, with the contents of a second container.

The invention will now be described in greater detail using non- limiting exemplary embodiment and referring to the drawings on which :

Fig. 1 shows a partial cross-section of a connector device according to the invention taken generally along the line I-I in Fig. 2,

Fig. 2 shows a top plan view of the connector device of Fig. 1, Fig. 3 shows an end view of the connector device of Fig. 1 as seen from the left-hand side in Fig. 1,

Fig. 4 is a detailed view of a part of the cross-section of a flow channel and the first piercing member of the connector device of Fig. 1,

Fig. 5 is an isometric view of the first piercing member of Fig. 4, Fig. 6 is a partial cross sectional view of the connector device corresponding to that of Fig. 1 but with an optional locking ring attached,

Figs. 7 and 8 show cross-sections of the connector device of Fig. 1 attached to diluent containers with differing closures.

Referring first to Fig. 2, a top plan view of the connector device 1 ac- cording to the invention is shown. Large parts of the connector device 1 are identical with parts of the connector device disclosed in EP-A-2043585, which is hereby incorporated in this description by reference.

The connector device 1 comprises a first tube member 3 and a second tube member 4. The second tube member 4 comprises an engagement member 14. The engagement member comprises a collar 17 with two flanges 33, which may bend for insertion of the neck of a bottle, a vial or the like. The engagement member 14 has an internal thread 59 at one end 15 adapted to correspond to a thread 58 provided externally on the second tube member 4. The external thread 58 is preferably provided along the entire length of the second tube 4, i.e. all the way from the first end 12 of the second tube 4 to the second end 13 of the second tube 4.

Associated with the first tube member 3 is a fluid flow channel 2 in which a first piercing member 9, which will be described in greater detail below, is held or retained.

Within the second tube member 4 a second piercing member 19 is held in a movable manner allowing it to change its position with respect to the second tube member 4. This second piercing member 19 is adapted for piercing a container held in the engagement member 14. In an inactive position, i.e. the position shown in Fig. 1, the second piercing means 19 is typi- cally housed partly within the second tube member 4, without extending into the first tube member 3 and with the piercing end extending beyond the second tube member 4 but not beyond the engagement member 14. This prevents any contact between the piercing member 19 and the surroundings, which increases the safety for the user as well as the patient. For prevention of undesired motion of the engagement member 14 in the rightward direction in Fig. 1 a removable locking means 21 may be provided. After removal of removable locking means 21, the end cap of a container (not shown) held by the engagement means may be pierced by the second piercing member 19, by turning the engagement means 14 on the thread 58, so as to move it in the right-hand direction in Fig. 1 into an active position. The end cap of the container would normally be of a construction similar to the end cap 11, which holds an elastomeric sealing 10 at the distal end 6 of the tube member 3, in a manner which allows the elastomeric sealing to be pierced, e.g. after removal of a protective cap 37. After the second piercing member 19 has pierced the elastomeric sealing of the container the inside of the container will be in fluid communication with the first tube 3. Optionally the second piercing means 19 may be held loosely within the second tube 4 and be adapted to further pierce a barrier or as seal between the second tube 4 and the first tube 3 in the active position, i.e. in addition to the piercing of the cap of the container upon turning the engagement member 14 on the thread 58. The thread 58 is constructed so that return movement is not possible, and accordingly attached vials or containers could not be removed again.

As can be seen from Fig. 1 the first tube member 3 comprises a flow channel 2, with a distal end 40 located within the tube member 3, and a proximal end 5 at an external extension of said tubular member 3 thus forming the proximal end of said side tubular member 3. At the distal end 6 of the first tube member 3 it is closed by an end cap 11, holding an elastomeric sealing 10. The flow channel 2 is preferably formed integrally with the first tube member 3 and of the same material.

Turning now to Fig. 4, a cross-section of a portion of the external extension of said first tube member 3 around the proximal end 5 of the flow passage 2 is shown in greater detail, together with the first piercing member 9, held in an arrested manner therein. An isometric view of a preferred embodiment of the first piercing member 9 itself is shown in Fig. 5, to which ref- erence may also be made in the following.

As can be seen, the first piercing member 9 comprises a pointed head 7, in shape not unlike an arrowhead, with a point 8 at the proximal end of the piercing member 9. The pointed head 7 is arranged at the proximal end of a shaft 41. The pointed head 7 comprises at least one rib 16 extending in a plane corresponding to the crosswise and lengthwise direction of said shaft 41. The rib 16 has a taper towards the point 8 at the proximal end, and thus forms first barb 18 directed away from the point 8 at the proximal end, still very much like an arrowhead. Preferably there are two opposite ribs 16 arranged on either side of the shaft 41, so as to form a generally triangular pointed head, as perhaps best seen in the cross-section of Fig. 4. As can be seen from the cross-section, the width of the pointed head 7 at the barb 18 is adapted to match approximately the external diameter (of the distal end 5) of the external extension of the flow channel 2. The shaft 41 comprises an oblong slit 20, which extends along the shaft 41, and forms a though hole in the crosswise direction of the shaft 41, i.e. in a direction perpendicular to the plane of the ribs 16. The oblong slit 20 thus extends along a length of said shaft 41 between said proximal end 8 and the distal end 30 of the piercing member. The pointed head 7 comprises at least one further tapered rib 23 arranged in e.g. a right angle to plane of the first rib 16, and the pointed head may comprise a flattened portion 24, i.e. without a taper, in front of said further tapered rib 23 towards the point 8 at the proximal end.

To facilitate the penetration of the pointed head 7 through the closure, such as through the elastomeric sealing 31 of the first container 22, cf. Figs. 7 and 8, the rib 16 may comprise a cut-out 25 so as to provide a part of the rib 16, i.e. a barb portion 26, with increased flexibility. This flexibility may further be increased by using a further cut-out 27 in another side of the generally triangular shape of the rib 16, i.e. the opposite side of the barb portion 26. Preferably this cut-out 27 is provided in such a manner that a secondary barb 28 is formed below the first barb 18, i.e. closer to the shaft 41. This increased flexibility, provided by the cut-outs 25, 27 on one or both sides of the barb portion 26, not only facilitates the penetration of an elastomeric sealing, but if the sealing is made of material less elastic than an elastomer, such as the plastic material typically used for diluent container bags, the hole pierced will still be small enough to prevent leakage.

The secondary barb 28, together with at least one further arresting member 29 provided on the shaft 41, is sufficient to hold and retain the piecing member 9 in the flow channel 2, the secondary barb 28 and the further arresting member 29 engaging on either end of a preferably cylindrical narrowed portion 42 formed at the end of the flow passage 2, when the piercing member 9 is inserted in the flow channel 2. This allows the piercing member 9 to be manufactured as a separate member and possibly of a different material than the first tube member 3.

The oblong slit 20 facilitates this insertion because it provides and increased flexibility of the shaft 41, but this is only a part of the purpose of the oblong slit 20. The main purpose of the oblong slit 20 is to serve as a flow passage allowing the diluent to flow from the first container 22 via the flow channel 2 into the first tube 3, where it is to be mixed with the contents of the container attached to the attachments means 14. Accordingly, the oblong slit 20 is located in such a manner in the piercing member 9 that it extends beyond the secondary barbs 28 towards the point 8 at the proximal end. This allows the diluent fluid from the container to flow over the ribs 16 on either side of the rib 23 into the oblong slit 20. The diluent fluent then flows partially in the oblong slit 20 and out again near the distal end 30 of the piercing member 9 and into the unobstructed flow channel 2. By using an oblong slit 20 it is in this way possible to keep the effective cross-section of the passage in the flow channel 2 rather big, so that any pressure increase in the passing liquid diluent is kept down. This is in some cases important as the diluents may comprise additives, such as medically active substances, which are pressure sensitive, prone to changes or even destruction at a molecular level upon pressure increases. Accordingly, the width of the oblong slit 20 is preferably in the interval between approximately 1/4 and 3/4 of the diameter of the shaft 41, preferably approximately 1/3. This provides a good compromise between the forces necessary to keep the arresting members 29 in engagement with the end of the narrowed portion 42, and the desire to obstruct the flow channel 2 the least possible.

In the preferred embodiment of the piercing member 9 shown in Fig. 5 it will be noted that the shaft 41 comprises two essentially flat sides 32 (one not visible) and two rounded sides 38. The cross-section of the shaft 41 is thus non-circular. Preferably, the rounded sides are generally circular, with a diameter fitting the diameter of the narrowed portion 42 of the flow channel 2, the cross-section thus comprising two diametrically opposed circular segments. The rounded sides 38 carry the arresting members 29. The oblong slit 20 forms a though hole between the essentially flat sides 32. The flat sides 32 facilitate the flow of diluent around the pointed head 7 and into the flow channel 2 without being obstructed by the sealing 31 of the closure of the diluent container 22. Furthermore the oblong slit 20 and the flat sides in combination restrict the flow in the flow channel 2 as little as possible. Other non-circular cross-sections of the shaft 41 may alternatively be used, but as will be understood from the above circular or at least partially circular cross- sections may also be used.

Constructing the connector device 1 as described above, i.e. with a first piercing member 9 with a shaft 41 with retaining means 29, a pointed head 7 with first barbs 18, and an oblong slit 20 in said shaft, where the shaft is located in a flow channel 2, allows the connector device 1 to be attached to the first container 22 without the use of any further attachment or holding means. Experience has shown that this attachment is sufficiently strong to ensure that the connector device 1 is not pulled free of the container 22 under the weight of an attached second container, possible additional connector devices 1 with additional containers, and the attached IV tube. Accordingly, this obviates the need for additional retaining members which in turn allows the connector device 1 to be used with various closures of first containers 22, as illustrated in Figs. 7 and 8.

This, however, does not exclude applying a separate retaining member 39, as illustrated in the alternative embodiment of Fig. 6. The separate retaining member 39, has an annular generally tubular shape, with tabs 34, 35 arranged in parallel with axial direction of the generally tubular shape, but directed in opposite directions, respectively. The tabs 34, 35 are provided with holding barbs 36, 37, respectively. The connector device 1 is adapted to engage the barbs 37 of the tabs 35 by means of an annular flange 43, formed concentrically around the flow channel 2 on the connector device 1. When the barbs 37 engage behind the flange 43, and a the elastomeric membrane of a neck of a first container 22 is pierced by the piercing means 9 and the proximal end 5 of external part of the flow channel 2, i.e. the situation illustrated without the separate retaining member 39 in Fig. 7, the hold- ing barbs 36 will engage behind the neck and hold the connector device 1 securely in connection with the first container 22.

Though the above description has been given with reference to specific embodiments, it should be noted that these are only examples, and the person skilled in the art will readily identify numerous other embodiments and variants without departing from the scope of the claims. In particular, many variations to the shape of the pointed head of the piercing member may be possible, e.g. omitting the flattened portion, using instead a continuous or discontinuous taper.