WO2012150587A1

WO2012150587A1 - Vial adaptor

Info

Publication number: WO2012150587A1
Application number: PCT/IL2012/000178
Authority: WO
Inventors: Igor Denenburg
Original assignee: Sabiedriba Ar Ierobezotu Atbildibu "Sdmd"
Priority date: 2011-05-03
Filing date: 2012-05-01
Publication date: 2012-11-08

Abstract

The invention is a vial adaptor for connecting a medical vessel to a drug vial. The vial adaptor comprises a hollow body having: a sidewall comprising two reversible locking elements located on opposite sides of its interior; a top wall comprising a central structure comprising a bottom part adapted for creating a fluid passage between the interior of the vial and a top part adapted to allow connection to a medical vessel; and a bottom that is open allowing the sidewall to be slipped over a cap of the drug vial. The sidewall has a horizontal cross-sectional area defined by a short axis that passes through the center of the locking elements and a long axis that is orthogonal to the short axis and that passes through the geometrical center of the cross-sectional area.

Description

VIAL ADAPTOR

Field of the Invention

The present invention relates to the field of liquid transfer devices. More particularly, the invention relates to an apparatus for transferring liquid drugs from disposable medication vials.

Background of the Invention

Drug vials are used in medicine as a sterile way of storing drugs as liquids or powders. Fig. 1 schematically illustrates a typical medicine vial. The vial (1) has a cylindrical body (3) and a smaller diameter neck portion (5) protruding upwardly from a shoulder portion (4). An annular shaped metallic cap (6) having a diameter larger than the neck portion (5) is located on top of vial (1). The cap (6) keeps the contents of the vial hermetically sealed within vial (1) and has a self-sealing septum (7) made of a polymeric material, e.g. rubber, in its center. A sharp instrument, e.g. a needle attached to a syringe can penetrate through the septum (7) and be used to extract the contents of the vial. Normally, when using a syringe for extracting a liquid drug from a medicine vial a large gauge needle is used to extract the drug and then it is exchanged for a smaller gauge needle for injecting the drug into a patient. In order to avoid having to exchange disposable needles a vial adaptor comprising means for piercing the septum of the vial on one side and means for connection with a needleless syringe on the other side is frequently supplied to provide a passage for fluids between the interiors of the vial and the syringe.

Prior art adaptors that are intended to provide needleless transfer of medications are generally of two types. The first type is an adaptor that, when fitted to the vial becomes permanently attached and can not be easily removed from the vial. A typical example of this type of vial adaptor is described in US 4,662,878. This patent describes a plastic adaptor, with a hollow cylindrical body that can be connected by means of fluid tight seals to a medicine vial at its bottom end and to a needleless injector at its top end. The hollow body is divided into a top part and a bottom part by a wall. The bottom part of the body is adapted to shde over the top of the vial and to become permanently attached onto the vial by means of a plurality of detents which lock onto the top of the vial and prevent the release of the adaptor. A sharp tipped hollow probe, located at the center of the bottom part of the body of the adaptor penetrates the seal of the vial allowing a liquid drug to be extracted through the hollow probe and transferred into the needleless injector.

This type of adaptor is not suitable in at least two scenarios which arise in the transfer of drugs. In the first scenario, only a small amount of the drug contained within the vial is needed. In this case, after transfer of the required amount of drug and disconnecting the needleless injector, the remaining portion of the drug and attached adaptor may have to be discarded because of the danger of contamination if the vial is stored for later use with the seal of the vial kept open by the probe of the adaptor or when connecting a second needleless injector. In the second scenario drugs may have to be drawn into a single needleless injector from two or more vials. In this case, after attaching an adaptor and withdrawing the drug from the first vial, a second adaptor must be attached to the second vial and the needleless injector must be disconnected from the first adaptor and connected to the second one, i.e. because of the permanent connection to the vial, this type of vial adaptor can not be used to complete all phases of the drug transfer. The second type of prior art vial adaptor has a flexible locking system that can be easily removed from the vial when needed, and later connected to a different vial. This locking system however occasionally connects the adaptor to the vial very loosely and may allow the adaptor to be released unintentionally from the vial, before completion of the drug extraction procedure.

A typical example of this type of vial adaptor is described in WO 2009/105489. This patent application describes a vial adaptor configured to be attached to a wide range of vial sizes. The adaptor is connected to a needleless syringe at one end and to the medicine vial at its other end. The adaptor has one or two deflectable tabs on the sides of the adaptor, which can be either bent by hand of the user or in response to contact with the vial top, to lock the adaptor onto the vial by abutment surfaces extended in the direction of the vial. The deflectable tabs allow the easy release of the adaptor from the vial when one tab is pulled by hand opening the lock on one side thereby allowing the adaptor to be slid off the vial.

For some medical needs, the medicine administered to a patient is a combination of several drugs in liquid form that are stored in separate vials or the drug may be supplied in a powdered form that must be mixed with a solvent, e.g. water, that is supplied in a separate vial. In these cases a special type of vial adaptor is supplied for connecting the two vials together and for later extraction of the mixed medicine.

US 6,558,365 describes an aseptic mixing vial adaptor, comprised of two adaptors that are adapted to be locked together. At first one of the adaptors is connected to a medicine vial containing a powdered drug and the other adaptor is connected to a medicine vial containing the liquid. At a second stage, the adaptors are joined together so that the liquid may be transferred to the vial containing the powdered drug where they are mixed together. After the mixing is completed, the two adaptors are separated and a needleless syringe is connected to the adaptor of the vial containing the mixture for the extraction of the medicine. It is an object of the present invention to provide a vial adaptor for a secure connection and the extraction of fluids from a vial by means of a needleless syringe.

It is an additional object of the present invention to provide a vial adaptor having a flexible locking system that, on the one hand, provides a secure connection to a vial and on the other hand, allows the vial adaptor to be easily released from the vial when desired.

Further purposes and advantages of this invention will appear as the description proceeds.

Summary of the Invention

The invention is a vial adaptor for connecting a medical vessel to a drug vial. The vial adaptor comprises a hollow body having:

(a) a sidewall comprising two reversible locking elements located on opposite sides of its interior;

(b) a top wall comprising a central structure located at its center, the central structure comprising a bottom part, which protrudes downwards and is adapted for creating a fluid passage between the interior of the vial, and a top part, which protrudes upwards and is adapted to allow connection to a medical vessel; and

(c) a bottom that is open allowing the sidewall to be slipped over a cap of the drug vial. The sidewall has a horizontal cross-sectional area defined by a short axis that passes through the center of the locking elements and a long axis that is orthogonal to the short axis and that passes through the geometrical center of the cross-sectional area.

The sidewall is adapted such that: (a) in an unstressed configuration the shortest distance measured between the two locking elements measured along a line parallel to or coincident with the short axis is greater than the diameter of a neck of the vial and shorter than the diameter of the cap of the vial; (b) an inwardly directed force applied to locations on the sidewall intersected by the long axis causes the shape of the sidewall to be changed into a stressed configuration in which the shortest distance becomes longer than the diameter of the cap of the vial; and (c) the sidewall returns to the unstressed configuration upon removal of the force. In embodiments of the vial adaptor of the invention the outside surface of the sidewall at the locations at which the sidewall is intersected by the long axis are roughened of otherwise patterned to form gripping surfaces.

In embodiments of the vial adaptor of the invention portions of the material of the sidewall have been removed to form windows.

In embodiments of the vial adaptor of the invention the bottom part of the central structure comprises a hollow spike. Embodiments of the hollow spike comprise a pointed tip and at least one opening to allow fluid communication between the outside of the spike and its hollow interior.

In embodiments of the vial adaptor of the invention the top part of the central structure comprises a channel into which the tip of a needleless syringe can be inserted. The channel can have a sloping interior wall adapted to allow the tip of a syringe to be forced into the channel and held in place by friction. In embodiments of the vial adaptor of the invention the top part of the central structure comprises components of a locking system. The vial components of the locking system on the central structure can be either a male or a female Luer lock.

Embodiments of the vial adaptor of the invention are manufactured by molding a medical grade material. In embodiments of the vial adaptor of the invention the sidewalls have a thickness in the range of 0.5mm to 3.0mm.

Embodiments of the vial adaptor of the invention comprise a filter. In embodiments of the vial adaptor of the invention the central structure is replaced with a flange having a component of a locking system created on its inner surface. The flange is located on the top center of the top wall surrounding a hole through the top wall. In embodiments of the vial adaptor of the invention the vial connector is adapted to allow connection to a needleless syringe.

All the above and other characteristics and advantages of the invention will be further understood through the following illustrative and non- limitative description of embodiments thereof, with reference to the appended drawings.

Brief Description of the Drawings

In the drawings:

- Fig. 1 schematically illustrates a typical medicine vial; - Fig. 2 schematically illustrates the structure of a typical embodiment of the vial adaptor;

- Fig. 3 schematically shows a vertical cross-section of the vial adaptor illustrated in Fig. 2;

- Fig. 4A schematically shows a bottom view of the side wall of the vial adaptor illustrated in Fig. 2 in its unstressed configuration;

- Fig. 4B schematically shows a bottom view of the side wall of the vial adaptor illustrated in Fig. 2 in its stressed configuration;

- Figs. 5A and 5B are bottom views that schematically show two examples of shapes of sidewall (11) that are suitable for the vial adaptor of the invention;

- Fig. 6 schematically illustrates an embodiment of the invention in which the connector comprises a male Luer lock;

- Fig. 7 schematically shows a vertical cross-section of a vial adaptor for a carpula according to the invention;

- Fig. 8 schematically illustrates a vertical cross-sectional view of a vial adaptor that comprises a filter;

- Fig. 9A to Fig. 9D schematically illustrates an embodiment of the vial adaptor of the invention configured to connect two vials together for the mixing of their contents before transferring the mixed contents to a medical vessel; and

- Fig. 10A to Fig. IOC schematically illustrates another embodiment of the vial adaptor of the invention configured to connect two vials together for the mixing of their contents before transferring the mixed contents to a medical vessel.

Detailed Description of the Drawings

Fig. 2 schematically illustrates the structure of a typical embodiment of the vial adaptor according to the present invention. The vial adaptor (2) comprises a hollow body (8) having a sidewall (11) and top wall (9). Located at the center of the top wall (9) there is a central structure (12), which comprises a bottom part that protrudes downwards and is adapted for creating a fluid passage between the interior of the vial and a top part that protrudes upwards and is adapted to allow connection of a medical vessel, i.e. a structure for containing or conveying a liquid transferred to it from a drug vial e.g. a syringe, catheter, hose, or stopcock. The bottom of the body (8) of the connector (2) is open allowing the sidewall (11) to be slipped over the cap (6) of the drug vial.

Fig. 3 schematically shows a vertical cross-section of vial adaptor (2) taken in plane E-E of Fig. 2. Two reversible locking elements (20) are located on opposite sides of the interior of sidewall (11). In this embodiment locking elements (20) are comprised of inwardly sloping sections (44) on the inside of sidewall (11). The inwardly sloping sections (44) have flat upper sides, or ledges (46). As will be described herein below, the ledges (46) fit around the neck (5) and under the cap (6) of the vial, thereby connecting vial adaptor (2) to vial (1). Reversible locking elements (20) can by provided in other forms, e.g. ridges created on the inside surface of sidewall (11), as long as they comprise a portion that projects inwardly from the sidewall in a manner similar to that of ledges (46).

Fig. 4A schematically shows a bottom view of the sidewall (11) of the vial adaptor (2). In this embodiment of the vial adaptor, in an unstressed state the circumference of sidewall (11) has an elliptical shape. Herein, the phrase 'shape in an unstressed state' refers to the 'natural' state of the sidewall (11), i.e. the shape in which the sidewall is manufactured. A straight line drawn between the centers of the two locking means defines a first axis B-B, known herein as the short axis, and a line that is orthogonal to the short axis and that passes through the geometrical center of the area bounded by sidewall (11) defines a second axis A- A, known herein as the long axis. The dimensions of the sidewall (11) are chosen such that distance di between the interior ends of the ledges (46) measured along short axis B- B, i.e. the shortest distance between the two locking elements (20), is greater than the diameter of the neck (5) of the vial (1) but less than the diameter of the cap (6). The sidewall (11) of vial adaptor (2) is made of flexible material so that an inwardly directed force along the axis A-A exerted on the two locations (22) on the sidewall (11) that lie a distance Di apart changes the shape of the sidewall (11) into a stressed configuration. In the stressed configuration, as is shown in Fig. 4B, the circumference of the bottom of the sidewall (11) assumes a roughly circular shape. The distance between points 22 becomes D2 < Di and at the same time the distance between the interior edges of ledges (46) on the sidewall located on B-B move away from each other to a maximum distance d2 > di, wherein d2 is greater than the diameter of cap (6) of the vial. Herein, the phrase 'shape in an stressed state' refers to the shape of the sidewall (11) when inward forces are applied to the outside surface of sidewall (11) at the two locations (22) at which long axis A-A intersects the sidewall.

Thus when the locations (22) located at the intersection of axis A-A with sidewall (11) of the vial adaptor (2) are pushed inward, the sidewall assumes a circular shape allowing it to be slipped over the cap (6) of the vial. When the inward force is removed internal stress in the material of the sidewall returns it to its original elliptical cross-sectional shape i.e. its unstressed configuration, with the ledges (46) around the neck (5) and confined under the cap (6) of the vial, thereby locking vial adaptor (2) to vial (1). To release the vial adaptor (2) from vial (1) it is only necessary to push inwards on locations (22) and the sidewall (11) can be slipped over the cap of the vial (1). In some embodiments the outside surface of sidewall (11) at locations (22) may be roughened of otherwise patterned to form gripping surfaces as shown in Fig. 2. In embodiments of the connector of the invention the sidewall (11) is made more flexible by removing portions of the material to form windows (10) as shown in Fig. 2. The circumference of the bottom of sidewall (11) of the vial adaptor of the invention need not necessarily have an elliptical shape in the unstressed configuration. It is only necessary that the cross-sectional area of the sidewall (11) can be described in terms of two orthogonal axis A-A and B-B and different lengths Di and di and that the sidewall (11) can be put into a stressed configuration wherein the lengths become D2 and d2 all of which satisfy the conditions described above. Figs. 5A and 5B show two examples of shapes of sidewall (11) that are suitable for the vial adaptor of the invention. Referring to Fig. 2 and Fig. 3, the central structure (12) is configured to allow fluid passage between the vial and the syringe. The bottom part of central structure (12) comprises a hollow spike (18) with a solid pointed tip (26) adapted to penetrate the rubber septum (7) at the top of the vial (1). The hollow spike (18) has small openings (24) cut into its side just above the tip (26) to allow fluid to flow into its hollow interior (14).

The top part of central structure (12) comprises a channel (30) to which a medical vessel can be connected such that it is in fluid communication with the interior (14) of spike (18).

Channel (30) can be adapted, for example by giving it a sloping interior wall, such that the tip of a syringe can be forced into the channel and held in place by friction. In other embodiments of the invention a locking system that provides a more positive connection between a medical vessel and the central structure of the vial adaptor can be provided. For example, Fig. 6 schematically illustrates an embodiment of the invention in which a medical vessel comprising a female Luer lock on its distal end can be easily connected to the central structure of a connector whose central structure comprises a male Luer lock (42) created on the top wall (12) of vial adaptor (2).

The vial adaptors of the invention are best manufactured by molding a suitable medical grade material e.g. nylon, polypropylene, or polycarbonate. To enable the adaptor to be relatively easily changed from the unstressed to the stressed configuration so that a user can attach the connector to the vial by simply pushing the two together so that the locking elements slide over the cap of the vial and so that a user can detach the connector from a vial by simply squeezing the ends of the long axis with his/her fingers, the walls of the main body (8) are made as thin as possible, e.g. 0.5 to 3.0mm depending on the size of the vial, while maintaining the strength and structural integrity of the connector. The vial adaptor of the invention may be manufactured in sizes suitable to be attached to the standard drug vials that are commercially available as well as to non-conventionally dimensioned vials. The following table shows the lengths of di and Di (see Fig. 4A) for prototypes of the vial adaptor of the invention that have been produced by the inventor for various standard vial sizes, wherein A = the diameter of the vial cap ±lmm.

If B = the diameter of the neck, then the lengths of di and Di can in general be determined for any vial, standard or nonstandard, from the relationships: A>di>B; Di>2A-B; di+Di>2A_; Di> di, A>B. It is noted that vial 8 is not a common size for drug vials. This diameter is characteristic of carpulas that have a ratio of length/diameter that are much larger than for vials. Fig. 7 schematically shows a vertical cross- section of a vial adaptor designed for connection to a carpula. Because of the small diameter of the septum the spike has to be narrower than those in adaptors for the larger sized vials. Thus for adaptors designed for connection to carpulas as shown in Fig. 7 the spike is optionally made of metal which is attached to the central structure (12) either by being placed in the mold and embedded in the plastic during the molding process of the rest of the adaptor or attached to the adaptor in a separate step after the molding has taken place, for example by being force fit into a socket created during the molding process.

Another embodiment of the vial adaptor of the invention, comprises a filter (32), is schematically shown in Fig. 8. This embodiment is intended to prevent contamination of the contents of the vial. In other embodiments the vial adapter comprises an air vent filter that allows clean air to enter the vial replacing the liquid that is drawn out by the syringe. Fig. 9A to Fig. 9D and Fig. 10A to Fig. IOC respectively schematically illustrate two embodiments of vial adaptors of the invention configured to connect two vials together for the mixing of their contents before transferring the mixed contents to a medical vessel. Fig. 9A shows a vial adapter (2) comprised of a side wall (11) having a horizontal cross-section defined by a short and a long axis as defined above and a top wall (9). Attached to the center of top wall (9) is a central structure (12) having a top part comprising a vertical channel (30) through its center and a male Luer lock (42) at its upper end and a bottom part comprised of spike (18). The spike (18) comprises openings near its tip that allow the channel (30) to be in fluid communication with the surroundings of the tip of spike (18) via the hollow interior of the spike.

Fig. 9B shows a modified vial adapter (2'). Sidewall (11') and top wall (9') are similar to the corresponding parts of the vial adapter shown in Fig. 9A; but, there is no central structure similar to central structure (12) of the vial adapter shown in Fig. 9A. Attached at the top center of top wall (9') is a flange with a female Luer lock (42') created on its inner surface. The top wall (9') has a hole through which a spike (18') (shown in Fig. 9C) is inserted. Spike (18') has openings near its tip allowing fluid communication between the surroundings of the tip and its hollow interior. The shaft of spike (18') is elongated so that, when the two vial adaptors (11) and (11') are connected together, the spike (18') projects above the top wall (9') a distance sufficient to pass through channel (30) in vial adaptor (2) and butt up against the top of spike (18) such that there is fluid communication between the interiors of both spikes and the tip if spike (18') is able to penetrate the septum of the vial attached to vial adaptor (11') as shown in Fig. 9D. The vial adapters shown in Fig. 9A and Fig. 9B and spike shown in Fig. 9C are supplied to the user connected together as shown in cross-section in Fig. 9D. To mix a liquid contained in a first drug vial with a powder in a second vial, the user presses the sidewalls of one of the vial adaptors to force the sidewalls into its stressed configuration, slides the sidewall over the cap of the vial, and removes the force allowing the sidewall to return to its unstressed configuration locking the vial to the adaptor. This is repeated for the other vial. The vial with the powdered drug is attached to vial adaptor (2) first and then vial with the liquid is attached to vial adaptor (2'). As the tip of spike (18') passes through the septum of the vial, vacuum in the vial containing the powder sucks liquid through openings (24'), the interiors of spikes (18) and (18'), and out through openings (24). After all of the liquid has passed into the vial containing the powder, the vial adaptors are separated. Spike (18') has a protrusion (34) near its tip that prevents it from being pulled back through the septum of the vial, so that as vial adaptor (2') and the attached empty vial is pulled away from the vial adaptor (2), spike (18') is pulled out of channel (30). The tip of a needleless syringe can now be inserted into channel (30) and used to draw the drug dissolved in the liquid out of the vial.

Fig. 10A shows a vial adapter (2) comprised of a side wall (11) having a horizontal cross-section defined by a short and a long axis as defined above and a top wall (9). Attached to the center of top wall (9) is a central structure (12) having a top part comprising a vertical channel (30) through its center and a male Luer lock (42) at its upper end and a bottom part comprised of spike (18). The spike (18) comprises openings near its tip that allow channel (30) to be in fluid communication with the surroundings of the tip of spike (18) via the hollow interior of the spike. The elongated shaft of a second spike (18') passes through channel (30) and butts up against the top of spike (18) such that there is fluid communication between the interiors of both spikes as shown in Fig. IOC.

The vial adaptor (2) as shown in Fig. 10A, with spikes pointing in opposite directions can be used to carry out the mixing procedure by attaching the vial adaptor to the vial containing the powder and then pushing the tip of spike (18') through the septum of the vial containing the liquid. After all of the liquid has been sucked into the vial containing the powder, the empty vial with the tip of spike (18') held inside it by protrusion (34) is pulled away allowing connection to a medical vessel, e.g. by inserting the tip of a needless syringe into channel (30). If desired to increase the stability of the vial containing the liquid during the transfer process a skirt (11"') shown in Fig. 10B can by provided. Skirt (11"') has the same structure as the sidewall of vial adaptor (2). Skirt (11'") fits over the top of vial adaptor (2) with its bottom edge pressed against the top of sidewall (11) as shown in Fig. IOC. Connection of the vials, the transfer of liquid to the vial containing the powder, separation of the vials, and attachment of a needless syringe are carried out mutatis mutandis as described herein above in relation to Figs. 9A to 9C.

Although embodiments of the invention have been described by way of illustration, it will be understood that the invention may be carried out with many variations, modifications, and adaptations, without exceeding the scope of the claims.

Claims

A vial adaptor for connecting a medical vessel to a drug vial, said vial adaptor comprising a hollow body having:

(b) a top wall comprising a central structure located at its center, said central structure comprising a bottom part, which protrudes downwards and is adapted for creating a fluid passage between the interior of the vial, and a top part, which protrudes upwards and is adapted to allow connection to a medical vessel; and

(c) a bottom that is open allowing said sidewall to be slipped over a cap of said drug vial;

wherein,

(i) said sidewall has a horizontal cross-sectional area defined by a short axis that passes through the center of said locking elements and a long axis that is orthogonal to said short axis and that passes through the geometrical center of said cross-sectional area;

(ii) said sidewall adapted such that in an unstressed configuration the shortest distance measured between said two locking elements measured along a line parallel to or coincident with said short axis is greater than the diameter of a neck of said vial and shorter than the diameter of said cap of said vial;

(iii) said sidewall adapted such that an inwardly directed force applied to locations on said sidewall intersected by said long axis causes the shape of said sidewall to be changed into a stressed configuration in which said shortest distance becomes longer than the diameter of said cap of said vial; and

(iv) said sidewall adapted such that said sidewall returns to said unstressed configuration upon removal of said force.

2. The vial adaptor of claim 1, wherein the outside surface of the sidewall at the locations at which said sidewall is intersected by the long axis are roughened of otherwise patterned to form gripping surfaces.

3. The vial adaptor of claim 1, wherein portions of the material of the sidewall have been removed to form windows.

4. The vial adaptor of claim 1, wherein the bottom part of the central structure comprises a hollow spike.

5. The vial adaptor of claim 4, wherein the hollow spike comprises a pointed tip and at least one opening to allow fluid communication between the outside of said spike and its hollow interior.

6. The vial adaptor of claim 1, wherein the top part of the central structure comprises a channel into which the tip of a needleless syringe can be inserted.

7. The vial adaptor of claim 6, wherein the channel has a sloping interior wall adapted to allow the tip of a syringe to be forced into said channel and held in place by friction.

8. The vial adaptor of claim 1, wherein the top part of the central structure comprises components of a locking system.

9. The vial adaptor of claim 8, wherein the components of the locking system are one of a male and a female Luer lock.

10. The vial adaptor of claim 1, wherein said vial adaptor is manufactured by molding a medical grade material.

11. The vial adaptor of claim 1, wherein the sidewalls have a thickness in the range of 0.5mm to 3.0mm.

12. The vial adaptor of claim 1, comprising a filter.

13. The vial adaptor of claim 1, wherein the central structure is replaced with a flange having a component of a locking system created on its inner surface, said flange located on the top center of the top wall surrounding a hole through said top wall.

14. The vial adaptor of claim 1, wherein said vial connector is adapted to allow connection to a needleless syringe.