Vial adapter having a needle-free valve for use with vial closures of different sizes

The invention relates generally to connectors of the type used for the transfusion and dispensing of injection fluids, and more particularly to a vial adapter which includes a sharpened tube designed to pierce the vial closure, a shield to protect the operator from accidental puncture with a sharp tube, and a valve connector, opposite the sharp tube for connection to another device for fluid flow.

Access openings for injecting fluid into the system or removing fluid therefrom are well known and widely used. Conventionally, vials of liquid medicaments for injection generally use rubber diaphragms located on the neck of the vial and provided for piercing made of an elastomer such as butyl rubber or the like. The closure itself, ensuring a firm seal of the diaphragm over the vial opening, is usually made of metal as a tin cap clamped over the rubber diaphragm and the vial neck flange by rolling. The outer diameter of this clamped member is a measure of the size of the vial. The closure also includes an opening or attachment port through which the diaphragm and the neck of the vial can be accessed. A sharp tube is inserted into this hole and locates the external element by piercing the rubber diaphragm. The open end of the tube, after passing through the rubber diaphragm, forms a connection with the interior of the vial to allow fluid flow.

The recognition of the usefulness of the adapters came as a result of their ability to use a sharpened tube in the fluid path to operate in a system that connects the vial to another fluid reservoir or to a fluid transfer device. The adapter may, for example, on the side opposite the sharpened tube, include a female Luer fitting for attachment of a syringe nozzle. The adapter thereby becomes a means for adapting the vial to the syringe or for adapting the sharpened tube to a syringe nozzle shaped as a Luer tip.

It has long been recognized that there is a means for attaching or seating a vial adapter to keep it in place while fluid is being transferred between the vial and other device and thus prevent the adapter and vial from unintentionally disconnecting. The adapter may, for example, have two arms which engage the neck or collar of the vial to secure the adapter to the vial. Other means include a skirt that surrounds the outer portion of the vial closure and grips the vial closure under its rolled-on cap, thereby providing a firm grasp of the vial neck flange and the bottom of the closure.

It is also recognized that it is advisable to provide the cap with a valve. The cap with the valve allows for connection with the interior of the vial by means of a sharpened tube without the risk of fluid leakage from the vial through the adapter. This method ensures that when a second device is prepared for a fluid, it can be easily attached to the adapter and the fluid flow between the vial and the second device will actuate the valve. One solution in use today is the use of two pieces to form a valve adapter for a vial. The vial adapter includes a sharpened tube designed to pierce the vial closure and a female Luer connector at the other end. A valve device with a male end is attached to the tip of the female Luer fitting. Thus, the operation of valve formation in the cap requires two parts. It is therefore desirable to have only one part which would not only allow the vial to connect to the blunt tube but also ensure that a valve will exist between them. Medical device manufacturers strive to obtain such effective and reliable devices, but at the same time they wish to keep their cost as low as possible.

Some of the existing and available attachments have various imperfections. For example, most adapters are designed to function with only one vial closure dimension. These adapters do not seat securely on vial closures whose diameter is smaller or larger than the diameter for which they are designed. Therefore, on vials with closures of other sizes, these caps are useless. Moreover, some of the vial adapters do not sufficiently protect the operator from accidentally biting the skin by the sharpened tube on the adapter. This is due to the fact that the cap guard or other device that holds the vial is not large enough to obscure the sharpened tube and the operator is thus exposed to the risk of a possible needle stick injury.

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The described restriction of the functionality of caps in cooperation with only one size of vials is also accompanied by an important cost element for hospitals or other medical entities, due to the need to have numerous types and sizes of caps in stock. This is due to the fact that vials with numerous neck sizes and closure diameters are widely available and frequently found in medical devices. It is common for hospitals to have a whole set of different adapters in stock to ensure they always have the correct adapter at their disposal to properly attach to the various closures of existing vials. If a hospital must maintain a stock of caps for every possible size of closure, this can result in logistical problems as well as increased costs. The most common vial closures are 13 and 20 mm diameter closures. Reducing the number of cap types that have to be in the hospital's warehouse can significantly reduce problems with stocking properly sized caps and save money.

In recent years, in an attempt to reduce the risk of accidental stings of medical personnel with sharpened devices, there has also been a trend to use devices with needle-free valves. Couplings or adapters for injecting or withdrawing fluid, in which sharp tubes are not used, have been introduced in particular numbers in particular. This is at least in part the result of research into the transmission of certain blood diseases by accidentally puncturing people dealing with sharp tubes. It is therefore desirable to have joints in which there are as few as possible sharpened surfaces, since this risk would be severely reduced thereby.

Further, it is desirable that the needle-free connectors be configured to allow easy antiseptic cleansing or other sterilization prior to connection. All external surfaces involved in the transfer of the fluid should be particularly easily accessible for cleaning prior to making the connection. Some earlier types of joints have a small gap or gap created by play between parts. Such a solution, when trying to sterilize the connector, is difficult and inconvenient to clean. In another alternative, connectors which require a cap to maintain a sterile connection before use are not readily available as they are inconvenient to remove and replace the cap and moreover the production of the cap increases the cost.

It follows from the above that it would be desirable to provide a needleless connector as part of the valve forming part of the above-mentioned cap. Such a step would increase the safety of medical personnel handling the cap.

While adapters exist that are capable of working with different vial closure sizes, the need to provide a practical way to accommodate a wide range of vial closure sizes is still evident. Where a adapter is used to connect to both the large size and the small size of a vial closure, the arms used therein for small size must yield when the connection is to be made to the larger size of the closure. The arms, which simply bend in this design, may still exert a relatively high pressure on the vial and cause the vial to pop out of the adapter. The small arms of such caps try to keep the adapter on the vial, while the longer arms tend to separate them. It is obvious that this solution is undesirable. It is also undesirable to have longer arms that simply break off when in contact with the larger size of the closures, as this means producing small plastic particles that are beyond any control. In addition, attempting to design breakable arms may add to the cost as the arms would have to be designed to withstand the specific forces involved in handling small vial closures while breaking when handling large vial closures.

For the above reasons, the people involved in the development of medical caps agree on the need for a universal single adapter capable of being used on vials of various sizes. There is also agreement on the need for a safety device to be placed around the sharpened tube of such a cap to protect operators from accidental pricking the skin. There is also a recognized need for an adapter that could connect the vial to another fluid transfer device by means of a needleless valve, thus obviating the need for sharp needles that could cause accidental punctures to operators. There is also a recognition of the need for the valve to be an integral part of the vial adapter. The present invention meets these and other needs.

The subject of the invention is a vial adapter for connecting to vial closures of various diameters, where each closure has a seal and each vial has a neck containing:

A cap body having a first end with an inner rim including an annular set of grippers and a second end, the body being thick at the inner rim; and a sharpened tube extending from a first end of the cap body for piercing the vial closure seal to create a fluid pathway between the vial and the first end.

The cap according to the invention is characterized in that the set of grippers comprises:

a first set of grippers extending radially from the inner rim inwardly, each having a first length and positioned and shaped to snap under a vial closure around a neck; and a second set of grippers extending radially from the inner periphery of the cap body inwardly, each having a second length greater than the first length of the first group of grippers and positioned and shaped to latch under a vial closure around the neck, each gripper of the second group it is so shaped that when the vial adapter is seated on a closure with a diameter larger than the selected size, each of the grippers in the second group flexes and deforms plastically thereby allowing the first group of grippers to click under the larger closure.

In one preferred embodiment of the vial adapter of the invention, the length of each of the first group of grippers is selected so that they can include vial closures of larger diameter.

In another preferred embodiment of the vial adapter of the invention, the length of each of the second group of grippers is selected to accommodate smaller diameter vial closures.

In yet another preferred embodiment of the vial adapter of the invention, the grippers of the second group are thinner than the body of the adapter at the inner periphery, and the plastic deformation of the second group of grippers occurs along the length of the thinner second grippers. In a particularly preferred case, the thickness of the second group of grippers is chosen such that, under plastic deformation, the second group of grippers does not exert a significant force on the closure that could cause the vial adapter to disengage from the closure.

In a further preferred embodiment of the vial adapter according to the invention, the second group of grippers comprises a narrowed segment in which plastic deformation occurs.

In a further preferred embodiment of the vial adapter of the invention, the length of each gripper in the second group is selected such that when the adapter grips a smaller diameter vial closure, each gripper of the second group is elastically deformed to grip the smaller closure. In a particularly preferred case, the second group of grippers is elastically deformed by an axial force along the central axis of the vial adapter such that the second group of grippers snaps under a retaining cap clamped around a rubber seal positioned in the vial opening.

In a further preferred embodiment of the vial adapter according to the invention, the second group of grippers is arranged on the inner rim such that the grippers of the second group alternate with the grippers of the first group.

In another preferred embodiment of the vial adapter of the invention, the adapter body further includes a shield that is part of the adapter body and extends from the first end far enough to cover the sharpened portion of the sharpened tube to prevent the operator of the vial adapter from being accidentally pricked by the sharpened tube.

In yet another preferred embodiment of the vial adapter of the invention, the tube includes a protruding rib which is positioned such that when the tube contacts the rubber seal closing the vial, the protruding rib prevents rotation of the tube with the rib piercing the rubber seal of the closure. In a particularly advantageous case, the rib protruding from the tube is elongated and is oriented parallel to the longitudinal axis of the central tube. In another particularly preferred case, the sharpened tube has a plurality of projecting fins disposed parallel to the longitudinal centerline of the tube.

In a further preferred embodiment of the vial adapter according to the invention, each of the grippers of the first group has an end and each of the grippers of the second group has an end, the ends of the first group of grippers and the ends of the second group of grippers being flush.

In a further preferred embodiment, the vial adapter of the invention further comprises a needle-free, repeatable-sealing valve at the other end.

The needle-free valve opens to allow fluid to flow when a blunt tube is seated in the valve, and closes when the blunt tube is removed to prevent fluid flow. More preferably, the needle-free valve capable of repeatedly sealing comprises a valve housing within which a deformable piston element is disposed to provide a fluid path through its interior, the piston element having an exposed opening which closes to prevent fluid flow when nothing is left to the needle-free valve. is introduced, and which opens to allow fluid to flow when fluid is introduced into the valve. In a particularly preferred case, the housing of a valve capable of repeatedly sealing comprises a port, an outlet port, a first section having a first cross-sectional dimension adjacent to the port, and a second section having a second cross-sectional dimension which is larger than the first section, the piston element comprising a deformable head. a plunger with a bore, moving from the first section of the valve housing, when fluid is introduced into the needle-free valve and moving towards the second section of the valve housing when nothing is introduced into the needle-free valve, and the first section being sized to deform the plunger head so that the orifice is closed; and the second section is sized to allow the plunger head to return to its natural shape where the bore is open, providing a fluid flow path between the port and the outlet. In another particularly preferred case, the housing of the needle-free valve capable of being repeatedly sealed has a connection port and an outlet port, and when fluid is introduced into the needle-free valve, the interior of the deformable piston element provides a fluid path through the needle-free valve between the port port and the outlet port.

The subject of the invention in the examples of implementation is shown in the drawing, where

Fig. 1 is a perspective view of a vial adapter conforming to the principles of the present invention from a sharp tube side view of the adapter; the cap has at one end a needleless Luer tip, a shield surrounding the sharpened tube at the other end, and an annular set of grippers disposed on the inner periphery of the shield, facing radially towards the sharpened tube and intended to grip the closure of the vial; the sharpened tube closure is meant to pierce;

Fig. 2 is a perspective view of the vial adapter of Fig. 1, viewed from the needle-free valve side of the cap, specifically illustrating the location of a needle-free, repeatable-sealing valve on the body portion of the cap including a female Luer tip as well as showing the plunger plunger. part of the part of the cap containing the needle-free valve;

Fig. 3 is a sectional view of the cap shown in Fig. 1 and Fig. 2 in its closed or inactive state, with an unactivated needleless portion capable of repeatedly sealing at one end, with a plunger member inside the housing, and with a sharpened tube surrounded by a slotted sheath with slots. a partial view of the gripper of the first gripper group as well as a folded gripper of the second gripper group;

Fig. 4 is a partially sectioned side view of the vial adapter with the skirt in fragmentary section ready to be mounted on a vial with a 20mm closure;

Fig. 5 is a partially sectioned side view of the vial adapter mounted to the vial with a 20 mm closure shown in Fig. 4; as you can see, the sharpened tube pierced the vial closure, thereby establishing a path for fluid flow from the vial;

Fig. 6 is a partially sectioned side view of the vial adapter seating securely on the vial with a 13mm closure; a second group of articulated grippers with the hinge structure engaging the 13 mm closure and the sharpened tube in position after piercing the vial closure;

Fig. 7 is the same view as Fig. 6 but without a section through the vial; the longer gripper of the second group is shown that engages the neck of the vial and its smaller closure; the gripper of the first group of shorter grippers is not in contact with the vial;

Fig. 8 is the same view as Fig. 5 but without a section through the vial; the longer gripper of the second group is shown plastically deformed at the location of the narrowed hinge and the gripper of the first group that engages the neck of the vial and its smaller closure;

Fig. 9 is a sharp-tube end view of the vial adapter of Fig. 1, particularly illustrating the annular set of the first group of grippers alternating with the second group of longer grippers, as well as showing the gaps existing in the shield. In Fig. 9, each long gripper is positioned between two short grippers;

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Fig. 10 is an enlarged view showing a detailed view of the hinge gripper of the second group of grippers shown in Fig. 9;

Fig. 11 is an enlarged detail view of the flexural gripper of Fig. 10 illustrating in particular the plastic deformation that takes place on the articulated portion of the gripper as the cap is seated on the large closure of the vial;

Fig. 12 is an enlarged view of the gripper of the first group of grippers in Fig. 9;

Fig. 13 is an end view of the adapter in an alternative embodiment to Fig. 9 of the vial adapter, showing in particular a different arrangement of the annular set of grippers with two shorter grippers interposed between each of the two longer grippers;

Fig. 14 is an enlarged view of the sharpened tube in an alternative embodiment where the longitudinal ribs extending from the base of the tube are particularly well visible and prevent it from rotating when pierced into the diaphragm of the vial closure;

Fig. 15 is a view similar to Fig. 3 except that a Luer connector has been inserted into the valve and in response the internal plunger has returned to flow through the cap to its natural open position to provide fluid flow through the cap;

Fig. 16 and Fig. 17 are views of a plunger member as applicable to a needleless valve of a vial adapter showing the elliptical shape of the plunger head with a marquee-shaped naturally open bore.

As shown in the drawing illustrating the invention, in which, throughout the figures, reference numerals represent the same elements, shown in perspective in a bottom view of Fig. 1, a vial adapter 21 has a body 23 with a first end 23 that includes a skirt 27 with a surrounding sharpened point. a tube 33 with an annular set of grippers 28, and a second end 35 including a repeatably sealed needle-free valve 37. Details of the repeatably sealing needleless valve 37 are contained in US Patent 5,676,346 issued October 14, 1997 to Leinsing under the title. Needleless Connector Valve. This document is hereby incorporated by reference, although the valve is discussed generally below. In Fig. 1 it can be seen that the ring set of grippers comprises several short grippers 29 and several long grippers 31 (for clarity, only one of them, indicated by the respective reference numerals, is shown in the drawing). It should be noted that the sharpened tube 33 includes openings 39 through which fluid can flow.

The needle-free valve 37 can be better viewed with reference to the top perspective view of Fig. 2. At the other end 35, the repeatably sealable needle-free valve 37 includes a female Luer connector 41. The Luer connector 41 is configured to mate with all standard fittings. male ANSI tips as well as other blunt tubing or fluid transfer devices. Also noticeable is the plunger head 43 of the deformable piston element 45 with an orifice 47 that is naturally open but closed in this case to prevent fluid flow through the cap. In this embodiment, the piston element 45 is housed in a valve housing 49 that houses a transparent tubular element 51 and an opaque female Luer 41, mounted in this version on a body portion 51.

Fig. 3 is a partially sectioned side view of the cap, previously shown in perspective in Figs. 1 and Fig. 2. The piston element 45 has a hollow interior 53 allowing full fluid flow through the needle-free valve 37 into the connecting passage 55 in sharpened tube 33. The channel 55 of the sharpened tube 33 communicates with an aperture 39 at the sharp end of the tube and provides a fluid path for the fluid through the tube 33. In Fig. 3 adapter for vial 21 is shown in a condition without blunt tube insertion therein. However, since the plunger head 43 of the piston element 45 is provided with an orifice 47, the natural condition of which is an opening, and thus, with the opening of the piston element, it becomes possible for fluid to flow therethrough. In the configurations of Fig. 1, Fig. 2, and Fig. 3, the opening 47 is forcibly closed by the difference between it and the female opening 57 of the female Luer 41. An important detail is that the plunger head 43 is elliptical in shape and has an awning-shaped bore 47. The dimensions of the plunger head 43 are selected so that when the plunger head is pressed into the circular tapered bore 57 of the female Luer 41, bore 47 is closing completely, sealing the fluid path 53. Adjacent lips, fitting tightly together, form a seal and under the influence of the pressure present in the piston element of the internal fluid passage, when nothing is seated in the valve, they exert additional pressure to help close the opening; this is shown in Fig. 1 to Fig. 3. In order for the lips to function as a seal, they include conical sections protruding from the side walls of the opening. The angle of their taper is selected so that the pressure existing in the interior of the valve when the plunger is closed causes the lips to press against each other and to keep the opening closed.

The first end 25 of the body 23 also includes a base 61, from the center of which a sharpened tube 33 extends. The base also has a recess 63 into which a bellows portion 65 of the piston element is seated. In this embodiment, the piston element 45 includes a bellows with a total of four corrugations, although more or less may be encountered in other variations. The bellows portion 65 provides a resilient force that causes the plunger head 43 to move into the female Luer 57.

The sharpened tube 33 is contained within a protective sheath 27, the length of which is at least the same as that of the sharpened tube 33, and which surrounds the tube and protects the operator of cap 21 from being punctured by the sharpened end of tube 33. For simplicity, Fig. 3 shows only two grippers, one belonging to it. to the first group of grippers 29 and one belonging to the second group of longer grippers 31. These grippers are formed on the inner periphery 67 surrounding the sharpened tube 31 of the envelope 27. As shown in the following detailed description, as well as as shown in the other drawings, the grippers are used as a means of seating and clamping the vial adapter 37 on its closed rubber diaphragm and ring-clamped neck.

The female Luer connector 41 also includes an external thread 69 onto which an additional male Luer sealing ring can be threaded to ensure a tight fit of the two couplings.

Fig. 4 shows the application of a vial adapter 21 to a vial 71 provided with a closure 73. The sharpened tube 33 moves through the access opening 75 of the closure 73 and is pushed through the rubber diaphragm 77 to establish a fluid path and utilize the vial contents. covers diaphragm 77, except for access opening 75 only. The cap is rolled around the lower part of the vial neck flange, which ensures that the vial closure diaphragm is firmly fixed on the neck. In certain instances, the vial closure opening 75 includes a sheath that is perforated to peel it off (this sheath is not shown). The casing is removed by the operator who tears it off the opening by breaking the links between the perforations.

As can be seen from the details in Fig. 4, the drug vial 71 includes a body 81 connected to a neck 83 that accesses the interior of the vial 71 and terminates in a flange with an outwardly extending flange 79; the flange with the flange define the opening 85 of the vial 71. The surrounding of the opening 85 of the vial with an outer flange 79 makes it possible to conveniently clamp the closure 77 covering the opening of the vial 85 thereon.

It is also seen from Fig. 4 that each gripper of the first group of grippers 29 and each gripper of the second group of grippers 31 have ends 89, both of which are arranged at the ends of the grippers of the first group and of the second group of grippers. in one plane, marked in this embodiment variant by a dashed line and the number 87.

In other variants, the tips of the grippers are not placed in the common plane. An additional feature of the grippers is that the first group and the second group pass each other along the inner periphery 67 of the cover 27.

As can be seen from Fig. 1, Fig. 2 and Fig. 4, the cover 27 in this embodiment is longer than the length of the sharpened tube 33 in order to protect the operator of the cap 21 from being stabbed by the sharp end of the tube 33. The cover 27 is further provided with slots to provide a possibility. bending outwards when depositing on the closures of larger vials.

In particular, it can be seen from Fig. 5 that the first step in using the vial adapter 21 is to place the end of the adapter, including the sharpened tube 33 surrounded by a shield 27, in close proximity to the rubber diaphragm 77 on the vial closure 71. The cap is then manually pressed onto the closure 73 of the vial. 71 by a force axially directed along the central axis 91 of the sharpened tube 33 and large enough for the sharpened tube 33 to pierce the rubber diaphragm of the closure. If the diameter of the vial closure is relatively large, for example 20 mm or more, the second group of hinge grippers 31 will deform plastically during the vial's mounting movement and bend to a vertical or nearly vertical position approximately parallel to the central axis 91 of the vial (as seen in Fig. 5). At the same time, the first group of shorter and stiff grippers will engage the larger closure of the vial.

In this embodiment, the lower portion of the shield 27 includes a bell-shaped portion 93 that assists in aligning the shield 27 against the closure 73 of the vial.

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To aid in aligning the shield with the vial closure before the sharpened tip of the tube 33 penetrates the closure, in the embodiment shown, the bell portion extends further than the sharpened tip of the tube 33.

In the embodiment shown, the first set of grippers 29, having a shorter length, are designed such that when a cap is seated on a vial with a 20 mm ± 3 mm diameter closure, the first group of grippers will retain the cap in the position shown in Fig. 5. As the vial closure comes into contact with the first group of grippers 27, a second group of longer, articulated grippers 31 designed to engage vial closures with a diameter of 13 mm ± 4 mm plastically deforms and dislocates as shown in Figure 5. Plastic deformation of the second the group of grippers 31 occurs when the grippers are bent so that correspondingly high stresses occur in them. Moreover, the thickness of the second group of grippers is selected such that when they are plastically deformed, they do not exert a significant force on the closure 73 which exceeds the selected diameter. In the case of Fig. 5, the long grippers 31 are plastically deformed as shown so that they do not exert enough pressure on the vial to tear it out of the adapter. Instead, the deformed grippers 31 exert a slight relieving force against the clamping effect of the vial closure and itself inside the adapter 21.

If the vial closure 73 has a smaller diameter as shown in Fig. 6, and especially in this embodiment where the closure is 13mm 4mm in diameter, the first group of grippers 29 will not engage the vial closure device, but the second group of grippers will do so. 31. When the vial adapter 21 is manually pressed against the closure 73 of the vial 71 by a force directed along the central axis 91 of the sharpened tube 33, during this movement, the second group of longer, articulated grippers 31 elastically deforms and snaps under the annular cap of the closure 73. This is shown. in Fig. 6.

Fig. 7 and Fig. 8 show a schematic representation of the operation of the grippers on the closures of vials 73 of different dimensions. Fig. 7 schematically shows the operation of the second group of longer grippers 31 gripping the smaller vial closure 73, while the first group of grippers 29 performs no function. Fig. 8 first shows the plastic deformation of the second group of grippers 31 as the adapter 21 is fitted to a vial that is too large to be gripped by these larger grippers 31. Instead, the vial closure 73 is gripped by shorter grippers 29 belonging to the first group.

Fig. 9 is an end view of the vial adapter of Fig. 3 taken in the direction of the lines marked 9. There is a view of the inner rim 67 of the enclosure 27 showing the alternating arrangement of the first group of shorter grippers 27 and the second group of longer grippers 31. In the display of Fig. 9, a second group is shown. the grippers 31 pass the first group of grippers 29 on the inner periphery 67 such that each of the grippers of the second group is positioned between the two grippers of the first group. Since there are three grippers in each group, and in this case they are spaced equidistantly around the inner periphery 67, the grippers of each group are spaced 120 ° apart. In other embodiments, however, the grippers may be spaced at different angular distances. Fig. 9 shows the obvious central position of the sharpened tube 33.

Fig. 10 and Fig. 11 show an enlarged view of the changes taking place in the second group of grippers 31, each of which includes, in order to hinge or create a plastic deformation point, a narrowed segment 95. Fig. 10 shows in particular the gripper 31 in its normal state. configuration existing before seating the cap on the vial closure. In contrast, Fig. 11 shows the gripper of Fig. 10 after the narrowed segment 95 was plastically deformed and the gripper was permanently in a new vertical configuration, resulting from plastic deformation of the material. Plastic deformation of this gripper 31 belonging to the second group occurs - as shown in Fig. 11 and Fig. 8 - during the deposition process of the vial adapter 21 with the larger closure, in a variant where the closure has a diameter of approx. 20 mm.

Fig. 12 is an enlarged view of a gripper 29 of the first group of grippers 27 that is used to grip vial closures with a larger diameter, e.g., 20mm.

Fig. 13 illustrates an alternative embodiment of the annular set of grippers 97 in which the annular set of grippers surrounding the sharpened tube 33 is arranged on the inner periphery 67 of the shell 27 so that one gripper 31 of the second group of longer grippers alternates several grippers 29 with the first group of shorter grippers. In this variant, several shorter grippers 29 have a serrated profile, and between each pair of longer grippers there are three shorter grippers 29.

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Fig. 14 shows a sharpened tube 33 with an elongated rib 99 which is positioned such that when the tube contacts the rubber diaphragm of the vial closure and when the sharpened tube with the fin pierces the rubber diaphragm of the closure, the rib prevents rotation of the tube. As shown, the rib 99 protruding from the tube has an elongated shape and is located parallel to the longitudinal axis 101 of the central sharpened tube 33.

In the embodiment shown, the sharpened tube 33 has several ribs 99 protruding from the tube and counteracting its rotation.

Fig. 15 is a view similar to Fig. 3, except that a male Luer 103 is inserted into the needle-free valve 37 whereby piston element 45 is pressed further into valve body 23 and bellow spring portion 65 pressurizes. In response, opening 47 of resilient piston member 45 returns to its natural open state allowing fluid to flow through the needle-free valve and through channel 55 within sharpened tube 33, thus allowing fluid to flow through and through vial adapter.

Fig. 16 and Fig. 17 show further details of the piston element 45 shown and discussed above. The bellows portion 65 in these drawings has more folds than the piston portion shown earlier; however, the operation of the piston element is the same as discussed above with reference to Fig. 3 and Fig. 15. The elliptical shape of the piston head 43 is clearly visible with an awning-shaped bore 47, the natural condition of which is the opening.

It should therefore be considered that a comprehensive vial adapter has been developed. The design of this cap is such that the wearer, thanks to the existence of the cover, is prevented from being accidentally pricked by the tube, the cap can easily be used to adapt the pierceable diaphragms to cooperate with needleless devices. One cap houses both a sharpened tube and a needle-free unit capable of repeatedly sealing, thereby obviating the need for two separate caps. The adapter also reduces the need for multiple adapter sizes in stocks as adapters in accordance with the present invention are capable of being fitted to multiple sized vial closures.

While specific embodiments of the invention have been illustrated and described above, it will be apparent to those skilled in the art that various modifications may be made thereto without departing from the spirit and letter of the invention. Accordingly, there is no intention that the invention should be limited except as set out in the appendix.