WO2011004360A1

WO2011004360A1 - Fluid transfer devices for filling a cartridge with liquid drug dosage

Info

Publication number: WO2011004360A1
Application number: PCT/IL2010/000530
Authority: WO
Inventors: Moshe Barkan; Niv Ben Shalom
Original assignee: Medimop Medical Projects Ltd
Priority date: 2009-07-09
Filing date: 2010-07-01
Publication date: 2011-01-13
Also published as: IL199767A0

Abstract

Fluid transfer devices for use in manual cartridge filling procedure for filling a cartridge with a liquid drug dosage and kits, methods and cartridges therefor. Fluid transfer devices include a cartridge port for sliding receiving a cartridge's leading end and either a vial port for snap fitting onto a vial or a male connector for sealed fluid engagement with a conventional vial adapter including a female connector. The cartridges include a slidable seal and a manual push rod for releasable attachment to the slidable seal for enabling manual displacement of the slidable seal for aspiration and injection purposes.

Description

FLUID TRANSFER DEVICES FOR FILLING A CARTRIDGE WITH

LIQUID DRUG DOSAGE

Field of the Invention

The invention relates to fluid transfer devices for filling a cartridge with a liquid drug dosage.

Background of the Invention

Auto-injectors for self-administration of liquid drugs such as insulin typically employ so-called carpules or cartridges including an open ended tube hermetically sealed by a rubber septum at a leading end and a slidable seal at an opposite trailing end. Cartridges can contain a single liquid drug dosage or a multiple liquid drug dosage. Home users are typically supplied with pre- filled cartridges but may be supplied with empty cartridges requiring a manual cartridge filling procedure for filling same with a liquid drug dosage. The manual cartridge filling procedure includes the following steps: A user prepares a syringe with a liquid drug dosage, mounts a needle on the syringe, punctures the cartridge's rubber septum and injects the liquid drug dosage into the cartridge. The user may have an additional step of reconstituting the liquid drug dosage from a powdered medicament.

Commonly owned PCT International Application No. PCT/IL2007/000343 entitled Fluid Transfer Devices for Use with Cartridges and published under PCT International Publication No. WO 2007/105221 illustrates and describes fluid transfer devices for use with syringes and cartridges for assisting a manual cartridge filling procedure. The fluid transfer devices include a syringe port and a cartridge port for correspondingly slidingly receiving a syringe and a cartridge. WO 2007/105221 's Figures IA, 2, 3 and 4 show fluid transfer devices including a double ended main body having a cartridge port for telescopically receiving a cartridge and a syringe port for receiving a syringe. WO 2007/105221 's Figures IB and 5 show a fluid transfer device similar in construction and operation to the fluid control devices with rotationally detachable vial adapters as illustrated and described in US Patent No. 6,238,372 to Zinger et al.'s Figures 11 to 15.

The cartridge ports preferably includes a primary puncturing member and a secondary puncturing member for correspondingly puncturing a cartridge's rubber septum offset from its center for fluid transfer purposes between a syringe and a cartridge, and venting purposes. The fluid transfer devices are preferably used with stopping devices for preventing ejection of a cartridge's seal during a manual cartridge filling procedure.

There is a need for fluid transfer devices affording a more convenient manual cartridge filling procedure for filling a cartridge with a liquid drug dosage for subsequent use in an auto-injector.

Summary of the Invention

The present invention is directed toward fluid transfer devices for use in manual cartridge filling procedures for filling cartridges with liquid drug dosages from medicament containing vials. The present invention is based on provisioning an otherwise conventional cartridge including a slidable seal with a releasable attachment arrangement and a manual push rod for releasable attachment to the slidable seal for enabling manual displacement of same for aspirating a liquid drug dosage from a vial thereinto. Suitable releasable attachment arrangements include inter alia a screw thread arrangement, and the like. The cartridges can be employed for aspirating either a liquid drug dosage from a liquid medicament containing vial or a reconstituted liquid drug dosage from a powder medicament containing vial whose contents have undergone reconstitution.

The fluid transfer devices of the present invention include a double ended main body having a cartridge port for slidingly receiving a cartridge leading end and either a vial port for snap fitting onto a vial or a male connector for sealed fluid engagement with a conventional vial adapter including a female connector. Suitable vial adapters are illustrated and described in US Design Patent No. 427,308 to Zinger et al. and are commercially available from Medimop Medical Projects Ltd., Ra'anana, Israel. The male connector is preferably a male Luer lock connector.

Cartridge ports necessarily enable convenient manual withdrawal of a cartridge for subsequent deployment in an auto-injector. Cartridge ports can be provisioned with a cartridge snap fit arrangement for removable snap fitting onto a cartridge leading end. The cartridge snap fit arrangement can be implemented by a slotted skirt with a plurality of flex members with inwardly directed ridges for telescopically snap fitting onto a cartridge's leading end. Cartridges can be manually withdrawn from such cartridge snap fit arrangements by bearing a cartridge against the inwardly directed ridges of a slotted skirt's flex members to temporarily slightly outward flex them until a cartridge passes beyond their inwardly directed ridges. Alternatively, cartridge ports can be implemented with a finger operated cartridge snap fit arrangement for releasing a cartridge whereby the cartridge can be freely slidingly withdrawn.

Brief Description of Drawings

In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non- limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:

Fig. 1 is a pictorial representation of a kit including a cartridge, a push rod, a vial and a first preferred embodiment of a fluid transfer device with a cartridge port and a vial port for direct fluid communication between the cartridge and the vial;

Fig. 2 is a longitudinal cross section of an assemblage of Figure l's fluid transfer device, cartridge and vial;

Figs. 3A to 3E show the steps of a manual cartridge filling procedure for filling a cartridge with a reconstituted liquid drug dosage;

Fig. 4 is a longitudinal cross section of a second preferred embodiment of a fluid transfer device with a cartridge port and a male connector for use with a conventional vial adapter with a female connector for direct fluid communication between a cartridge and a vial;

Fig. 5 is a pictorial representation of an alternative implementation of Figure 4's fluid transfer device including a finger operated cartridge snap fit arrangement; and

Fig. 6 is a longitudinal cross section of an assemblage of Figure 5's fluid transfer device, cartridge and vial along line A-A in Figure 5.

Detailed Description of Preferred Embodiments of the Invention

Figures 1 and 2 show a kit 5 including a pre-filled diluent containing cartridge 10, a powder medicament containing vial 30 and a fluid transfer device 40 for use in a manual cartridge filling procedure for filling the cartridge 10 with a reconstituted liquid drug dosage.

The cartridge 10 includes an open ended tube 11 having a longitudinal axis 12, a small diameter cartridge leading end 13, an intermediate neck 14 and a wide diameter cartridge trailing end 16. The cartridge leading end 13 is hermetically sealed by a rubber cartridge septum 17 capped by a metal band 18 leaving a small exposed circular rubber surface 19 of between about 2mm and 3mm in diameter. The trailing end 16 is hermetically sealed by a slidable seal 21. The slidable seal 21 has an exposed trailing surface 22 formed with a screw thread blind bore 23 for screw thread attachment with a push rod 24 having a screw threaded leading end 26. The cartridge 10 contains diluent 27.

The vial 30 includes an open topped bottle 31 having a longitudinal axis 32 and hermetically sealed by a rubber vial stopper 33 capped by a metal band 34. The vial 30 contains a powder drug dosage 36 requiring reconstitution by the cartridge's diluent contents 27. The vial's powder drug contents 36 are typically stored under vacuum. Alternatively, the vial 30 can contain a liquid drug dosage suitable for direct transfer to an empty cartridge.

The fluid transfer device 40 has a longitudinal axis 41 and includes a double ended main body 42 having a cartridge port 43 for slidingly receiving the cartridge leading end 13 therein and a vial port 44 for telescopically snap fitting onto the vial 30. The cartridge port 43 includes a cartridge snap fit arrangement 45 implemented in the form of a slotted skirt 46 with a plurality of flex members 47 having inwardly directed ridges 48 for telescopically removably snap fitting onto the cartridge leading end 13 and a puncturing member 49 for puncturing the cartridge septum 17. The puncturing member 49 is preferably constituted by a metal needle having an outer diameter of, say, about 0.5mm.

The vial port 44 includes a slotted skirt 51 with a plurality of flex members 52 having inwardly directed ridges 53 and a hollow cannula 54 for puncturing the vial septum 33. The puncturing member 49 and the cannula 54 are co-axial with the fluid transfer device's longitudinal axis 41 and enable direct fluid communication between a cartridge 10 and a vial 30 in an assemblage 56 of the fluid transfer device 40, the cartridge 10 and the vial 30

(see Figure 2).

Figures 3A to 3E show the steps of a manual cartridge filling procedure using the kit 5 to reconstitute a liquid drug dosage to fill the cartridge with same as follows:

Figure 3A shows a user screw threading the push rod 24 into a pre-filled cartridge 10 depicted by arrow A, inserting the cartridge 10 into the cartridge port 43 depicted by arrow B and mounting the vial port 44 on the vial 30 depicted by arrow C to form the assemblage 56.

Figure 3B shows the vial 30's vacuum drawing the cartridge's diluent into the vial 30 as depicted by arrow D for reconstituting a liquid drug 57 in the vial. A user may additionally depress the push rod 24 to assist the vacuum to transfer the diluent to the vial 30.

Figure 3C shows the user inverting the assemblage 56 and aspirating the reconstituted liquid drug 57 into the cartridge 10 depicted by arrow E.

Figure 3D shows the user inverting the assemblage 56 into its original upright position, unscrewing the push rod 24 depicted by arrow F and detaching the cartridge 10 from the assemblage 56 depicted by arrow G such that the reconstituted liquid drug filled cartridge 10 is ready for use in an automatic pen (see Figure 3E).

The manual cartridge filling procedure in the case of a vial containing a liquid medicament instead of a powdered medicament omits the steps shown in Figures 3A and 3B for reconstituting a powder drug dosage to a reconstituted liquid drug dosage.

Figure 4 shows a fluid transfer device 60 for use with a conventional vial adapter 70 with a female connector 71. The fluid transfer device 60 has a similar construction as the fluid transfer device 40 and similar parts are likewise numbered. The fluid transfer device 60 differs from the fluid transfer device 40 insofar the former 60 includes a male connector 61 for screw thread fluid engagement on the female connector 71 for enabling fluid communication between a cartridge 10 inserted into the fluid transfer device 60's cartridge port 43 and a vial 30 inserted into the vial adapter 70. The male and female connectors 61 and 71 are preferably Luer lock connectors.

Figures 5 and 6 show the fluid transfer device 60 with a cartridge port 43 implemented by an open ended cartridge holder 62 for slidingly receiving a cartridge 10 and a finger operated cartridge snap fit arrangement 63 for initially snap fitting onto a cartridge 10 on its sliding insertion into the cartridge holder 62 and enabling a user to manually release the cartridge 10 for enabling the cartridge 10 to be freely slidingly withdrawn from the cartridge holder 62. The cartridge holder 62 is typically dimensioned such that a cartridge 10 can be inserted about midway along its length. The cartridge holder 62 includes a pair of opposite support members 64 and the finger operated cartridge snap fit arrangement 63 includes a pair of opposite flex members 66 each having an outwardly directed finger operated member 67. The flex members 66 each terminate in an inwardly directed ridge 68 toward the male connector 61 for snap fit insertion against a cartridge's neck 14 on sliding insertion of a cartridge 10 into the cartridge holder 62. Depression of the pair of opposite flex members 66 towards one another depicted by arrows H outwardly urges the inwardly directed ridges 68 depicted by arrows I thereby enabling a cartridge 10 to be freely withdrawn.

While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims. For example, the cartridge port 43 can be alternately implemented by the open ended cartridge holder 62 and the finger operated cartridge snap fit arrangement 63.

Claims

CLAIMS:

1. A fluid transfer device for use with a cartridge, a vial and a push rod, the cartridge including a small diameter cartridge leading end, an intermediate neck, a large diameter cartridge trailing end, a cartridge septum hermetically sealing the cartridge leading end, a slidable seal hermetically sealing the cartridge trailing end, and the slidable seal having an exposed trailing surface for releasable attachment by the push rod,

the vial including a vial stopper and containing a liquid drug dosage, the fluid transfer device having a longitudinal axis and comprising a double ended main body including

i) a cartridge port for slidingly receiving the cartridge leading end therein and a hollow puncturing member for puncturing the cartridge septum on said sliding insertion of the cartridge leading end into said cartridge port, and

ii) a vial port for telescopically snap fitting onto the vial, said vial port including a hollow cannula for puncturing the vial stopper on said snap fitting thereinto, said hollow cannula being in flow communication with said hollow puncturing member for enabling direct flow communication between the cartridge and the vial on their respective sliding insertion into said cartridge port and snap fitting into said vial port whereupon the push rod enables aspiration of the liquid drug dosage from the vial into the cartridge for filling the cartridge with the liquid drug dosage.

2. A fluid transfer device for use with a cartridge, a vial, a push rod and a vial adapter,

the cartridge including a small diameter cartridge leading end, an intermediate neck, a large diameter cartridge trailing end, a cartridge septum hermetically sealing the cartridge leading end, a slidable seal hermetically sealing the cartridge trailing end, and the slidable seal having an exposed trailing surface for releasable attachment by the push rod, the vial including a vial stopper and containing a liquid drug dosage, the vial adapter having a skirt for telescopically snap fitting on the vial, a hollow cannula for puncturing the vial stopper on the snap fitting the vial adapter on the vial and a female connector for sealed fluid connection with a male connector,

the fluid transfer device having a longitudinal axis and comprising a double ended main body including

ii) a male connector for sealing fluid engagement with the vial adapter's female connector for enabling direct flow communication between the cartridge and the vial on their respective sliding insertion into said cartridge port and snap fitting into the vial adapter whereupon the push rod enables aspiration of the liquid drug dosage from the vial into the cartridge for filling the cartridge with the liquid drug dosage.

3. The device according to either claim 1 or 2 wherein said cartridge port includes a cartridge snap fit arrangement for removably snap fitting onto the cartridge leading end on said sliding insertion of the cartridge leading end thereinto.

4. The device according to claim 3 wherein said cartridge snap fit arrangement is manually operable for releasing a cartridge whereby the cartridge can be freely slidingly withdrawn from said cartridge port.

5. A cartridge for use with a push rod, the cartridge comprising:

(a) an open ended tube having a small diameter cartridge leading end, an intermediate neck, and a wide diameter cartridge trailing end;

(b) a cartridge septum hermetically sealing said cartridge leading end; and (c) a slidable seal hermetically sealing said cartridge trailing end and having an exposed trailing surface for releasable attachment by the push rod for enabling manual displacement of said slidable seal.

6. The cartridge according to claim 5 wherein said exposed trailing surface includes a screw thread blind bore and the push rod includes a screw thread leading end for screw thread attachment in said screw threaded blind bore.

7. A kit for use in a manual cartridge filling procedure for filling a cartridge with a liquid drug dosage, the kit comprising:

(a) a medicament containing vial;

(b) a cartridge with a slidable seal according to either claim 5 or 6;

(c) a fluid transfer device according to any one of claims 1 to 4; and

(d) a push rod for releasable attachment to said slidable seal.

8. A method for filling a cartridge with a liquid drug dosage comprising the steps of:

(a) providing a kit according to claim 7;

(b) preparing an assemblage including the push rod releasably engaged to the slidable seal and the fluid transfer device mounted on the cartridge and the vial containing a liquid drug dosage;

(c) aspirating the liquid drug dosage from the vial into the cartridge;

(d) removing the cartridge from the assemblage; and

(e) detaching the push rod from the cartridge.

9. The method according to claim 8 wherein the vial contains a powder drug dosage and further comprising the step of:

(f) diluting the powder drug dosage to reconstitute the liquid drug dosage in the vial prior to step (c)'s aspiration into the cartridge.