WO2020037393A1

WO2020037393A1 - Easy linking transfer system with venting

Info

Publication number: WO2020037393A1
Application number: PCT/CA2019/000119
Authority: WO
Inventors: Mathieu VIENS; Samuel DESPREZ-LANGLOIS
Original assignee: Duoject Medical Systems Inc.
Priority date: 2018-08-22
Filing date: 2019-08-19
Publication date: 2020-02-27
Also published as: CA3015070A1

Abstract

A transfer device for transferring one or more components of a pharmaceutical composition between containers, the transfer device comprising a central portion (210) having a metallic needle (212) extending therethrough, the metallic needle having a piercing end (214) with a fluid passageway (216) extending therethrough, a spike (218) located adjacent the piercing end (214) of the metallic needle (212), the spike (218) having a spike passageway (222) extending therethrough with an outlet from the spike passageway (222) being located proximate the central portion (210), the spike (218) and the metallic needle (212) having a common wall therebetween.

Description

EASY LINKING TRANSFER SYSTEM WITH VENTING

FIELD OF THE INVENTION

The present invention relates to a transfer system and more particularly, relates to an assembly for transferring one or more components of a pharmaceutical composition between containers.

BACKGROUND OF THE INVENTION

Typically, a syringe is filled manually by aspirating a liquid pharmaceutical component from a pharmaceutical vial which traditionally has a penetrable closure. The syringe has a needle that penetrates the penetrable closure following which the syringe is typically filled by drawing air into the body of the syringe, aligning the needle with the vial’s penetrable closure and inserting the needle through the penetrable closure into the vial.

Subsequently, the vial is inverted and air is forced from the body of the syringe into the vial. The plunger is then withdrawn to draw out the desired volume of the pharmaceutical component into the syringe and the needle is removed from the vial.

Many pharmaceutical preparations must be distributed and sold as two or more separate components— typically a solid component and a liquid component. They are mixed just prior to administration. In some instances, the two or more components may each be liquid and require mixing prior to administration to the patient.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an assembly for transferring the contents of a first container to a second container.

According to one aspect of the present invention, there is provided a transfer device comprising a central portion, a metallic needle extending through the central portion, the metallic needle having a piercing end, the metallic needle having a fluid passageway extending therethrough, a spike located adjacent the piercing end of the metallic needle, the spike having a spike passageway extending therethrough, an outlet from the spike passageway being located proximate the central portion, the spike and the metallic needle having a common wall therebetween.

In a large number of cases, the transfer device of the present invention provides for the easy linking of a vial and a syringe whereby the components may be mixed to form a composition in the syringe ready for patient injection.

The contents of the vial may be any suitable pharmaceutical component though in many instances, it will be a dry pharmaceutical component such as a lyophilized product. However, as previously mentioned, it could also be a liquid component.

The syringe will normally contain a liquid component which is frequently a diluent for the active pharmaceutical ingredient in the vial. The syringe may be any conventional syringe readily available from different manufacturers. Typically, the syringe will contain a piston and have a back stop or finger flange attached to one end thereof. A plunger rod will be attachable to the piston of the syringe.

One problem with known transfer devices is that access to the needle or plastic spike within the transfer device should be minimized to prevent accidental pricks. Once such transfer device is shown in International Application PCT/CA2010/001399, the teachings of which are incorporated herein by reference. In the transfer device, a cap is provided to permit access to the syringe side of the device and the luer connection cannot be accessed until the cap is removed. However, the cap can only be removed when the device is coupled to the vial. On some occasions, it is deemed desirable to re-use the transfer device. With the aforementioned transfer device, this was not possible as the vial remains secured to the transfer device and both are disposed of as a unit.

On other occasions, it is deemed best practise to not permit re-use of the transfer device due to possible contamination. However, it is still desirable to protect the user from the needle or spike.

In one embodiment of the present invention wherein the device may not be re-used, the moveable member engages the wall of the housing upon upward movement when the vial is inserted into the housing. The rotational movement moves it to an upper position which, when the vial is pulled down, the moveable member moves to a position where it still protects against accidental needle prick but also cannot be moved upwardly again as it is in a locked position.

In a further embodiment, the moveable member is retracted down to a position from which it started to enable re-use of the transfer device.

In a still further embodiment of the invention, there is provided a transfer device wherein a fluid such as a gas may be vented from a vial when fluid is transferred thereto. In this embodiment, the transfer device is designed to transfer fluid from a first container to a second container. Frequently the second container will contain a powdered medicament while the first container will contain a liquid or diluent therefore.

The transfer device will include a central portion which will have a metallic needle extending therethrough. The metallic needle has a fluid passageway which is designed to transfer the fluid from the first container to the second container. As such, the metallic needle will have a piercing end which is designed to pierce the septum. Located adjacent thereto is a spike which is preferably formed of a plastic material and which will also have an angled end for piercing. The spike will have an inlet which is preferably slightly spaced apart from the inlet to the piercing end of the metallic needle. The spike and the metallic material preferably share a common wall.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus generally described the invention, reference will be made to the accompanying drawings illustrating an embodiment thereof, in which:

Figure 1 is a side elevational view of a transfer device according to the present invention;

Figure 2 is a side elevational view, partially in section, of a vial containing a medicant;

Figure 3 is a side elevational view of a syringe and plunger rod;

Figure 4 is a cross sectional view of the transfer device prior to its use;

Figure 5 is a side sectional view of the device being placed on a vial;

Figure 6 is a side sectional view showing piercing of the vial;

Figure 7 is a cross sectional view illustrating the cap being removed;

Figure 8 is a view, partially in cross section, of a syringe being attached to the transfer device;

Figure 9 is a cross sectional view illustrating a syringe being ready to be placed on the vial;

Figure 10 is a cross sectional view illustrating the syringe attached to the vial;

Figure 11 is a sectional view illustrating the mixing of components;

Figure 12 is a sectional view illustrating the aspiration of the mixture into the syringe; Figure 13 is a cross sectional view illustrating placement of the transfer assembly on a vial;

Figure 14 is an exploded view illustrating the transfer assembly and the vial prior to insertion of the vial;

Figure 15A is a bottom perspective view of a transfer assembly according to one embodiment of the present invention;

Figure 15B is a bottom plan view thereof;

Figure 16A is a perspective view of the transfer assembly according to a further embodiment;

Figure 16B is a bottom plan view thereof;

Figure 17A is an exploded view of the transfer assembly;

Figure 17B is a bottom perspective view thereof;

Figures 17C to 17E show the sequence of placing the transfer assembly on the vial;

Figures 17F to 17H illustrate the placement of the transfer assembly in a further embodiment thereof on a vial;

Figure 18 is an exploded view of the transfer assembly;

Figures 19A to 19D are perspective views illustrating placement of the transfer assembly on a vial and removal thereof;

Figure 20A is a side elevational view of a modified transfer assembly when packaged;

Figure 20B is an exploded view thereof; and

Figure 21 is a cross sectional view of the needle assembly of the transfer assembly of

Figures 20 A and 20B. DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings in greater detail and by reference characters thereto, there is illustrated a transfer system which is generally designated by reference numeral 10 and which is suitable for use with a vial generally designated by reference numeral 12.

Vial 12 has a body 14 with a neck sealed by a septum 16 over which there is a cap 18. A medicant 20 is contained within body 14 and would typically comprise a dry ingredient although a fluid may also be utilized.

Transfer system 10 includes an outer housing 24 and a circular side wall 26. On circular side wall 26 there is a protrusion 28 near the bottom thereof. On its upper end, there is provided a luer connection 30. An inner wall 32 mounts a needle 34 which is hollow in nature and has a piercing end 36. As previously mentioned, needle 34 may be a spike.

Mounted interiorly of outer housing 24 is a moveable member 40. Moveable member 40 has a top wall 42 with an aperture 44 centrally located therein to permit the passage of needle 34. Extending downwardly from top wall 42 is a first leg 46 and a second leg 48. First leg 46 has an outwardly extending flange 50 at the bottom thereof while second leg 48 also has an outwardly extending flange 52.

A cover 56 is provided to receive transfer system 10. Cover 56 has a side wall 57 with a groove 58 which is adapted to engage with protrusion 28 to retain transfer system 10 in position. Side wall 57 is provided with an outwardly extending flange 60 at the bottom thereof. Flange 60 is designed to receive a peelable sealing strip 62 so as to provide a hermetically sealed package.

The transfer system of the present invention is preferably utilized with a syringe which has a syringe body 66 and a plunger 68 mounted therein. A plunger rod 70 is designed to be screwthreadably engageable with plunger 68. Syringe body 66 includes a backstop 72 to permit proper gripping by the hand of a user. At its front end, syringe body 66 includes a luer connector 74. Typically, syringe body 66 is filled with a diluent 76 although any desired fluid may be utilized.

As shown in Figures 8 and 9, plunger rod 70 is connected to plunger 68 and the diluent 76 is then forced into vial body 14 as shown in Figure 10. The medicant and diluent may then be mixed and the assembly inverted as shown in Figure 11. The mixture 80 is then aspirated back into syringe body 66. The mixture 80 is then ready for injection when a needle assembly is connected to luer connector 74.

In the embodiment of Figures 17A to 17H, it will be noted that outer housing 24 is provided with a pair of apertures 86 in side wall 26. Also, in this embodiment, there are provided an extra pair of legs 87 each having buttons 88 formed on an exterior surface thereof. In this embodiment, when the moveable member 40 moves upwardly, buttons 88 engage in apertures 86.

On the interior surface of wall 26, there are provided ribs 90 which have a groove 92 formed therein. Thus, when pressure is exerted on buttons 86 as vial 12 is being withdrawn, moveable member 40 will move downwardly until the top wall 42 engages with groove 92. This retains moveable member 40 in position for further use.

In the embodiment of Figures 18 to 19D, it will be noted that top wall 42 is provided with protrusions 96 and locking latches 98. On the interior there are provided ribs 100 and angled side wall portions 102. The arrangement is such that upon upward movement of moveable member 94, protrusions 96 engage with angled side wall 102 to rotate moveable member 40. Upon withdrawal, locking latches 98 engage with rib 100 so as to prevent further use of the transfer member.

As shown in Figures 18 and 19A to 19D, housing 26 includes a pair of flexible tongues 104 (only one shown). On the inner surface of each flexible tongue 104, there is provided an angled surface 106 and a slot or recess 108. Initially, when vial 12 is inserted, pressure is exerted on angled surface 106 of flexible tongue 104 to release top 42 from the locked position shown in Figure 19A to the released position shown in 19B. Subsequently, movable member 40 is rotated as shown in Figure 19C. During this rotation, projections 96 enter slot or recess 108. This holds the flexible tongue outwardly such that insertion of a further vial will not contact angled surface 106 and top 42 will be retained in a locked position.

As shown in Figures 20A and 20B, the transfer assembly will comprise the transfer device 202 as previously described herein. A cover 204 is mounted over and a removable seal 206 applied.

The transfer device includes a needle assembly generally designated by reference numeral 208 and thus seen in Figure 21. A portion of the body 210 has a needle 212 extending therethrough. Needle 212 is of a metallic material and is over moulded with body portion 210. Needle 212 includes a piercing tip 214 and a needle passageway 216 extends therethrough. A plastic spike 218 is formed as a portion of needle 212. The plastic spike has a piercing tip 220 with a spike venting passageway 222 formed therein. As may been seen, needle passageway 216 and spike venting passageway 222 lie side by side with a portion of needle 212 forming one wall of spike venting passageway 222. Both needle piercing tip 214 and spike piercing tip 220 are angled to provide the best piercing capability. Both tips are sharpened as is known in the art. It will noted that needle passageway 216 extends a little bit further down than the opening to spike venting passageway 222. In use, spike passageway 216 is utilized for transfer of the drug or liquid into a further container, while spike venting passageway 222 permits the egress of either a gas or a liquid therefrom. When transferring from one container to another, the transfer device is inverted and a fluid (normally a gas) in the second container will exit through spike venting passageway 222 to permit equalization of pressures and to allow the liquid transferred through needle passageway 216 to flow smoothly into the second container.

In general, it is preferred that the volume capacity of the venting channel be at least equal to or greater than the volume capacity of the transfer channel.

It will be understood that the above described embodiments are for purposes of illustration and that changes and modifications may be made thereto without departing from the spirit and scope of the invention.

Claims

WE CLAIM:

1. A transfer device comprising:

a central portion (210);

a metallic needle (212) extending through said central portion, said metallic needle having a piercing end (214), said metallic needle having a fluid passageway (216) extending therethrough;

a spike (218) located adjacent said piercing end (214) of said metallic needle (212), said spike (218) having a spike passageway (222) extending therethrough, an outlet from said spike passageway being located proximate said central portion, said spike (218) and said metallic needle (212) having a common wall therebetween.

2. The transfer device of Claim 1 wherein said spike passageway (222) has an inlet located upwardly from said piercing end of said metallic needle.

3. The transfer device of Claim 1 wherein said piercing end (214) of said needle (212) and said piercing end of said spike (218) are angular in nature.

4. The transfer device of Claim 1 wherein said spike (218) is formed of a plastic material.

5. The transfer device of Claim 1 wherein said central portion (210) is formed of a polymeric material.