US20040024354A1

US20040024354A1 - Transfer device and method for transferring a pharmaceutical component between a vial and a syringe

Info

Publication number: US20040024354A1
Application number: US10/367,607
Authority: US
Inventors: David Reynolds
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-01-11
Filing date: 2003-02-14
Publication date: 2004-02-05
Also published as: JPH11510087A; DE69712499T2; US6149623A; ES2176661T3; PT928182E; US6638244B1; DE69712499D1; CA2242915A1; JP4187790B2; AU1362697A; ATE217181T1; AU726244B2; EP0928182B1; CA2242915C; EP0928182A1; DK0928182T3; WO1997025015A1

Abstract

A transfer device and method for deploying one or more pharmaceutical components between a medicine vial and a syringe.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of co-pending patent application Ser. No. 09/668,159 filed on Sep. 25, 2000, which is a continuation-in-part of application Ser. No. 09/114,063, filed on Jul. 13, 1998, which is a continuation-in-part of International Patent Application PCT/CA97/00017, filed on Jan. 10, 1997, which is a continuation-in-part of application Ser. No. 08/584,041, filed Jan. 11, 1996 and now abandoned.[0001]

FIELD OF THE INVENTION

The present invention is directed to a syringe adapter, and more particularly to a device that allows a user to reconstitute medicine in sealed vials.

BACKGROUND

Many pharmaceutical preparations must be distributed as two or more separate components which can only be combined shortly before administration of the preparation, usually because the combined preparation is subject to rapid deterioration or otherwise unstable, and the components are only stable when stored separately. Typically at least one component of such a preparation is a liquid which acts as a solvent, diluent or carrier for the other component.

Traditionally such preparations have been prepared shortly before administration by taking one component packaged in a conventional pharmaceutical vial having a neck closed by a penetrable elastomeric stopper secured to a neck of the vial by a cap, taking a second liquid component in a hypodermic syringe, injecting the second component into the vial through the stopper, swilling the vial impaled on the syringe to dissolve, dilute or suspend the first component in the second component, and aspirating the combined components back into the syringe by withdrawing its plunger. This procedure requires a degree of dexterity, is subject to the errors commonly associated with manual onsite preparation of pharmaceuticals, and may compromise sterility. If a third component is used, the procedure must be repeated.

In endeavours to overcome these problems, many proposals have been made for systems to provide prepackaged two component pharmaceuticals, but these tend to suffer from one or more problems of their own such as complex and expensive structure requirements for specialized filling equipment, complex manipulation at the time of use, and often most serious of all, a heavy burden in time and expense in obtaining regulatory approval for a new product.

U.S. Pat. No. 3,872,867 (Killinger) utilizes a tubular assembly incorporating a double ended cannula, into which two pharmaceutical vials are pressed in order to combine components in the two vials. The system requires that one of the vials is under vacuum at pressure, and merely results in a vial containing the combined product, which must still be transferred to a syringe for administration.

U.S. Pat. No. 3,563,373 (Paulson) discloses an arrangement utilizing two cartridges in tandem for packaging a two component pharmaceutical, utilizing an intermediate assembly incorporating a double ended needle, which penetrates the piston of one cartridge and neck stopper of the other. The arrangement cannot utilize a standard pharmaceutical vial.

U.S. Pat. No. 4,060,082 (Lindberg) also requires two syringes in tandem for combining a two component pharmaceutical, as well as specialized auxiliary pistons in the syringes.

U.S. Pat. No. 4,583,971 (Bocquet et al) discloses apparatus for transferring liquid through a cannula from a flexible container to dissolve a pharmaceutical, and returning the solution to the flexible container. The system is dependent upon manipulation of a tangible closure through the flexible container and could not be used to transfer liquid from a syringe to a pharmaceutical vial and back again.

U.S. Pat. No. 5,171,214 (Kolber et al) discloses a combination of a vial assembly, a syringe assembly, and an adapter for attaching the vial assembly to the syringe assembly so that a liquid constituent may be transferred from the syringe to the vial and the admixed compounds returned to the syringe. A special vial and special syringe are required, and indeed the system is predicated upon the use of a proprietary vial assembly.

An object of the present invention is to provide a delivery system for two component pharmaceuticals which is economical to manufacture, easy to manipulate, and can minimize regulatory burdens.

SUMMARY OF THE INVENTION

According to the invention, there is provided an activation assembly for preparing a prefilled syringe from separately prepackaged components of a multicomponent pharmaceutical preparation, the assembly comprising a two part tubular body; the body defining in a first part a first cylindrical recess at one end of a diameter to receive, as a sliding fit, a discharge end of cylindrical body of a protosyringe at which end is located a closure, broachable on activation of the protosyringe, the recess also receiving a substantial portion of the cylindrical body of the protosyringe, which contains a first, liquid component of the pharmaceutical preparation and which is provided at its opposite end with a piston displaceable longitudinally of the cylindrical body and forming a hermetic seal therewith; a second cylindrical recess defined in the other end of the tubular body by a second detachable part to receive a cap securing a penetrable closure at the neck of the pharmaceutical vial containing a second component of the pharmaceutical preparation; the tubular body defining in said first part a passage connecting the cylindrical recesses; a hub movable longitudinally of the tubular body within the passage; a cannula extending longitudinally of the tubular body from said hub to a distal end directed towards the second recess; a penetrable shield member covering the distal end of the cannula and located to contact a penetrable closure of a pharmaceutical vial inserted in the cylindrical recess, and a hollow cylindrical overcap concentric with the hub assembly and located within the tubular body in the first cylindrical recess, the overcap being connected to the hub to limit movement of the latter into the passage; the depth of the cylindrical recesses, the length of the passage connecting the recesses, the extent of the cannula from the hub, and the location of the overcap i the first cylindrical recess being such that upon a protosyringe received in the first cylindrical recess and a vial received in the second recess being displaced towards each other, the overcap is displaced onto the discharge end of the protosyringe and the hub moves longitudinally so that the cannula penetrates the penetrable shield member and the penetrable closure of the vial to place the cap of the protosyringe and the vial in fluid communication through the cannula; wherein the protosyringe and the vial can be driven directly towards each other to effect penetration of the shield member and the penetrable closure of the vial, wherein a portion of the hub supporting the cannula is separately formed and detachable from the hub assembly, the hub assembly having a luer on which said separately formed portion is releasably lodged, and wherein means is provided within the detachable part of the tubular assembly to detain, within the tubular assembly, said one end of the cannula when the cannula is driven into a position into a position penetrating the cap of the pharmaceutical vial.

Two terms used in the preceding paragraph and elsewhere in this specification and the appended claims require mention. A ‘protosyringe’ is an assembly intended to form the basis of a prefilled syringe but requiring the addition of components to form a complete syringe. At minimum, it includes a cylindrical body containing at least a component of a pharmaceutical product, the body being closed at one end by a broachable closure and being at an opposite end with a piston connected to or provided with means for connection to an activating plunger so that the latter may be used to displace the contents of the body. Protosyringes include bottomless vials as described in my U.S. Pat. No. 5,364,369; cartridges; and prefilled syringes requiring at least addition of an overcap as defined below and introduction of a further component of the pharmaceutical product to provide a ready to use syringe. An ‘overcap’ is a cap adapted to be lodged on the cap of a protosyringe and providing means for supporting a needle or other instrumentality through which contents of a syringe formed from the protosyringe may be discharged. In some instances, a complete prefilled syringe itself may be used as a protosyringe if it has a luer connection closed by a cap of penetrable material over which an overcap may be received.

The invention also extends to the combination of such an assembly with a protosyringe and/or pharmaceutical vials already engaged in their associated cylindrical recesses. If the protosyringe is already engaged in the first cylindrical recess, its free end may be covered by a removable cap to prevent accidental projection into the cylindrical bottom resulting in premature actuation of the assembly. When a protosyringe or vial is preengaged in its cylindrical recess, the associated sealing member in the assembly is in resilient contact with the penetrable closure of the vial in areas concentric with the cannula so as to help maintain sterility of areas of the sealing members and closures intended to be penetrated by the cannula.

The hub assembly and a modified overcap may also be utilized in conjunction with a protosyringe or pharmaceutical vial to provide alternative delivery systems for pharmaceuticals contained in the protosyringe or vial.

Further features of the invention will be apparent from the following description of embodiments of the invention.

IN THE DRAWINGS

FIG. 1 is an exploded view of the components of an assembly according to the invention, including both a protosyringe, in this case a bottomless vial, and a pharmaceutical vial; [0017]
FIG. 2 illustrates an assembly according to the invention, including a bottomless vial, as it might be shipped; [0018]
FIG. 3 illustrates a similar assembly, but further including a pharmaceutical vial, ready for activation; [0019]
FIG. 4 illustrates in part sectional view components of an assembly according to FIG. 3, but with upper components removed for clarity; [0020]
FIG. 5 is a similar view to FIG. 4, but showing the illustrated components in the relationship which they assume after activation of the assembly in order to prepare a completed prefilled syringe; [0021]
FIG. 6 is a view of the assembly corresponding to FIG. 3, after activation; [0022]
FIG. 7 is a view of the assembly after the plunger has been pressed upwardly to transfer liquid from the bottomless vial to the pharmaceutical vial; [0023]
FIG. 8 is a view showing a mixing step; [0024]
FIG. 9 shows upper portions of the assembly being removed, leaving a syringe ready for application of a needle or other discharge means; [0025]
FIG. 10 shows a partially exploded view of a modified embodiment of delivery system utilizing a different form of protosyringe; [0026]
FIGS. 11 and 12 are fragmentary sectional views of an alternative form of syringe socket and associated parts which permit elements of the delivery system to be used in further embodiments of delivery system in conjunction with prefilled protosyringes or pharmaceutical vials; [0027]
FIG. 13 shows in section a cap which may be applied to a luer on a hub portion of the embodiment of FIGS. 11 and 12 to enable the hub to be driven from the position to FIG. 11 to that of FIG. 12 to activate a prefilled protosyringe; [0028]
FIG. 14 shows in an exploded view parts of an alternative activation system for use with the embodiment of FIGS. 11 and 12 so as to activate a syringe or vial for use in conjunction with a standard flexible mini-bag; [0029]
FIG. 15 shows an assembled syringe ready for activation; [0030]
FIG. 16 shows an activated syringe applied to a mini-bag; [0031]
FIG. 17 is an exploded view illustrating components of a presently preferred modification of the embodiment of FIGS. [0032] 1-9;
FIG. 18 shows the parts shown in FIG. 17 assembled ready for use, less the plunger; [0033]
FIGS. 19 and 20 illustrate a presently preferred modification of the embodiment of FIGS. 11 and 12; [0034]
FIG. 21 illustrates the assembled components of a further embodiment of assembly according to the invention; [0035]
FIG. 22 is an exploded view of components of a hub assembly used in the embodiment of FIG. 21; [0036]
FIG. 23 illustrates a modification of the embodiment of FIG. 18, showing how the assembly of the invention may be used to activate pharmaceuticals having more than two components; [0037]
FIG. 24 illustrates an assembly in accordance with a further embodiment of the invention; [0038]
FIG. 25 is a flow diagram illustrating the preparation of assemblies in accordance with the embodiment of FIGS. 17 and 18; and [0039]
FIGS. 26 and 27 are exploded and assembled views of a further embodiment of the invention. [0040]
FIG. 28 is an exemplary illustration of a pharmaceutical delivery system including a pharmaceutical transfer assembly in a retracted or “unactivated” postion according to an embodiment of the invention. [0041]
FIG. 28[0042] a is a variation of the embodiment of FIG. 28.
FIG. 28[0043] b is a variation of the embodiment of FIG. 28a showing a fully assembled device.
FIGS. 29 and 30 illustrate successive stages in deployment of the pharmaceutical delivery system of FIG. 28 for transfer of a pharmaceutical component between a vial and a syringe. [0044]
FIGS. 29[0045] a and 30 a illustrate successive stages in deployment of the pharmaceutical delivery system of FIG. 28a for transfer of a pharmaceutical component between a vial and a syringe.
FIG. 30[0046] b is a plan view taken along line A-A of the transfer device of FIG. 30A.
FIG. 31 is an exemplary illustration of a pharmaceutical delivery system including a pharmaceutical transfer assembly in a retracted or “unactivated” postion according to another embodiment of the invention. [0047]
FIG. 31[0048] a is a variation of the embodiment of FIG. 31.
FIG. 31[0049] b is a variation of the embodiment of FIG. 31 a showing a fully assembled device.
FIGS. 32 and 33 illustrate successive stages in deployment of the pharmaceutical delivery system of FIG. 31 for transfer of a pharmaceutical component between a vial and a syringe. [0050]
FIGS. 32[0051] a and 33 a illustrate successive stages in deployment of the pharmaceutical delivery system of FIG. 31 a for transfer of a pharmaceutical component from a vial to a syringe.
FIG. 34 is an exemplary illustration of a pharmaceutical delivery system including a pharmaceutical transfer assembly in a retracted or “unactivated” postion according to yet another embodiment of the invention. [0052]
FIG. 34[0053] a is a variation of the embodiment of FIG. 34 showing a fully assembled device.
FIGS. 35 and 36 illustrate successive stages in deployment of the pharmaceutical delivery system of FIG. 34 for transfer of a pharmaceutical component between a vial and a syringe. [0054]
FIG. 37 is an exemplary illustration of a pharmaceutical delivery system including a pharmaceutical transfer assembly in a retracted or “unactivated” postion according to yet another embodiment of the invention. [0055]
FIG. 37A is a perspective view of a portion of the transfer assembly shown in FIG. 37.[0056]

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring first to FIGS. [0057] 1 to 3, the parts are shown of an assembly for preparing a syringe containing a pharmaceutical preparation, components A and B of which are contained respectively in a pharmaceutical vial 2 and a protosyringe in the form of a bottomless vial 4 consisting of a cylindrical body 6, open at one end and provided with a neck 8 at its other end, the neck being closed by an elastomeric closure 10 secured in place by a metal cap 12 crimped over the neck. A piston 14 is lodged in the open end of the body, the piston being provided with means 16 by which a detachable plunger 18 may be secured to the piston. The plunger will normally be shipped detached from the piston, both to reduce the overall length of the assembly, and to permit a removable cap 20 to be applied over a projecting end of the bottomless vial 4 as shown in FIG. 2 so as to prevent inadvertent premature activation of the assembly.
At least one of the components A and B is liquid; usually it will be convenient to locate a liquid component in the bottomless vial but it would be possible to locate a solid component in the bottomless vial provided that the latter also contains an air or gas volume sufficient to displace liquid contents of the [0058] vial 2.
Since a typical two component pharmaceutical for administration via a syringe comprises an active ingredient and a liquid solvent, diluent or carrier (hereinafter collectively referred to as diluent for convenience) which in the majority of cases will be one of only a few different types (most usually distilled water), it will usually be advantageous to place the active component in the [0059] vial 2; this is because in many, if not most cases, a suitable vial package of the active ingredient will already be certified by regulatory cylindrical recess 31 into which may be slid the body 6 of the bottomless vial 4, although not initially to the full extent permitted by the depth of the recess.
The [0060] end portion 26 of the syringe socket includes a guide 52 with detents 53 for controlling longitudinal movement of a hub 34 having gapped longitudinal ribs 33. The hub is formed at a front end with a liquid delivery conduit through a standard luer as utilized in the industry for coupling needles, or other delivery instrumentalities forming liquid delivery conduit extensions, to syringes and other sources of liquid pharmaceuticals. Such a luer comprises an internally threaded socket 36 for locking a needle in place, and a tapered central spigot 38 for establishing a seal with a complementary socket on the needle. In the present instance, a hollow transfer needle 40 has a socket 41 lodged on the central spigot, but is not provided with threads to engage those of the socket 36, so the needle 40 may be pulled from the spigot 38. A tapered shoulder 42 is formed on the transfer needle 40. The hub 34 has a hollow needle or cannula 44 projecting from its end opposite the spigot 38 and in communication with a central passage in the spigot. A flexible needle sheath or shield 46 of thin rubber covers the needle 44, having a portion 48 engaging a socket in the end of the hub 34, and a flattened end 50 over the free end of the needle. Internally of the guide 52, the end portion 26 of the syringe socket also contains an extension of the cylindrical recess 31 dimensioned to provide an overcap which is a press fit over the cap 12 of the bottomless vial 4.
The [0061] vial coupling 22 has a passage extending from recess 30 which receives vial 2 to its internally threaded end, the passage being closed by a rubber stopper or shield 54. Between the rubber stopper and the internally threaded end of coupling 22, passage is formed internally with resilient pawls 56 which will detain the shoulder 42 of the needle 40 when the latter is pressed past the pawls.
The assembly just described may be shipped on its own with neither vial installed, in which case a removable cover (not shown) will be required to cover the cylindrical recess in the [0062] coupling 22 to maintain sterility, or with one or both vials installed (see FIGS. 2 and 3). When a vial 2 is installed, any removable central portion of a cap 60 covering a penetrable closure 58 of the vial is flipped off, so that the penetrable closure may contact a rib 64 on the stopper 54 to enclose an axial sterile zone of the two rubber parts 58 and 54. Likewise, an axial zone of the closure 10, similarly exposed, contacts the end 50 of the needle sheath 46 to provide protected zones on the contacting rubber parts.
In order to activate the assembly, after installation of the vials to provide the arrangement shown in FIG. 3, the bottomless vial is pressed into the [0063] syringe socket 24, and the plunger 18 is attached to reach the condition shown in FIG. 6.
Thereafter, the assembly is inverted and [0064] plunger 18 is activated to project the liquid content B from the bottomless vial into the pharmaceutical vial, (see FIG. 7), the assembly then being swilled as shown in FIG. 8 to dissolve, mix or suspend the contents of the vial 2 in the liquid, which is then aspirated back into the bottomless vial by withdrawing the plunger to reach a condition similar to that of FIG. 6, except that component A is now incorporated into component B to leave a product C in the bottomless vial. The vial 22 is now unscrewed from the syringe socket 24 and withdrawn, taking with it the transfer needle 40 which is pulled off the spigot 38 by the pawls 56, thus leaving the luer of hub 34 ready to receive a needle or other fluid connection instrumentality, and providing a completed ready to use syringe, filled with the two component pharmaceutical (see FIG. 9). The hub 34 is retained on the cap 12 of the bottomless vial by the syringe socket 24, with the needle providing a passage between the body 6 and the luer 36, 38.
If the initial position of liquid and solid components is reversed, the step of FIG. 7 may be performed without inversion, with reciprocation of the syringe plunger being used to force air or gas from the [0065] vial 4 to the vial 2, and liquid from the vial 2 to the vial 4.
A presently preferred modification of the assembly described above is shown in FIGS. 17 and 18, in which the same reference numerals are used to designate similar parts, and only the differences are described. In this modification, the [0066] flange 35 of the hub 34 is extended to form the overcap, and the portion 26 of the syringe socket 24 acts to receive the forward portion of this overcap when the syringe body 6 is forced forward against and into the overcap during activation of the syringe. As best understood from FIG. 25, this rearrangement facilitates assembly. The cap 20 is replaced by a driver in the form of a tubular cylindrical element 21, which snaps into the opening of the syringe socket 24 as shown in FIG. 18 in a position in which it covers the rear of the protosyringe, and from which position it can be driven forward to activate the assembly. The element 21 has a bottom aperture to accommodate the plunger 18. The stopper 54 is replaced by a flexible sheath 54 similar to the shield 46, since this is found to simplify assembly and provides complete coverage of the needle 40.
It will be noted that the [0067] plunger 18 in the embodiment of FIGS. 17 and 18 is provided with ribs 18 at its distal end. This facilitates an alternative mode of activation of the assembly in which the plunger 18 is assembled to the piston 14 prior to activation, and activation is achieved by pressure on the plunger. This initially drives the hub forward so that the cannula 40 penetrates the closure of he vial 2, then drives the cap 12 into the overcap 35 to penetrate the closure of the protosyringe so that the contents of the latter may be delivered into the vial. The ribs 18 a abut the periphery of the opening in the bottom of the driver 21 as the plunger nears the end of its stroke, and presses forward the driver so that it snaps into the sleeve 24, thus signalling the completion of activation.
Various modifications are possible within the scope of the invention, the above description being of a presently preferred example. For instance, the [0068] needle 40 could be permanently secured to the hub 34, and the pawls in the vial omitted. Such an arrangement does not provide the user with any choice as to the needle to be used on the finished syringe, and needle length may be severely limited by the need to avoid excess needle extent to the vial 2, which would make it difficult to aspirate its contents.
Likewise, the [0069] bottomless vial 4 may be replaced by other forms of protosyringe such as cartridges, or by a prefilled syringe provided with an elastomeric closure covering a luer connection, the front end of the syringe accepting an overcap providing such a needle connection and acting to retain the hub. Such an arrangement is exemplified in FIG. 10, which shows the bottomless vial replaced by a protosyringe which is a conventional prefilled syringe having a conventional luer nozzle 101 protected by a protective rubber sealing cap 100 over a front end of the syringe body, and the syringe socket 24 is modified in shape to receive the body 6 of the syringe, with longitudinal internal ribs 102 to grip the syringe body. As before, a cap 20 prevents the syringe body from being driven fully into the syringe socket 24 until activation is required, and the end 50 of the shield 46 rests against the cap 100 to help maintain sterility of the zones to be penetrated by the needle 44.
Yet further forms of protosyringe may be employed. For example, a known form of diluent vial comprises a [0070] body 6 in the form of a glass tube with a piston at both ends. The piston at one end is similar to the piston 14 with an extension similar to the extension 16. The piston at the other end fulfils the function of the neck 8, stopper 10 and cap 12 of the bottomless vial shown in FIG. 1. In conventional use, this other end of the vial is inserted into an open end of a sleeve which at its other end supports a luer or needle externally and an axial hollow pin projecting internally. The piston at the other end of the vial has an axial passage, through the piston and an outward extension of the piston, closed at its outer end by a bung which is displaced by the hollow pin on insertion of the vial into the sleeve, thus establishing communication between the needle or luer and the interior of the vial. Protosyringe from a vial into a syringe is completed by applying a plunger to the piston at the first end. This type of protosyringe can be substituted in the present invention for that shown in FIG. 1 or FIG. 17. During activation, the overcap 16 or 35 will be driven into the extension of the piston at said other end of the vial so that the needle 44 penetrates the sheath 46 and displaces the bung. The bung may be replaced by an integral septum in the passage of the piston which is penetrated by the needle 44.
The syringe socket itself may be made detachable from the completed syringe except for the overcap, or may be truncated in length as shown in FIGS. 11 and 12. It will be seen that the [0071] syringe socket 24 is shortened and reduced in diameter to receive the cap 12 of a bottomless vial, the syringe socket being pushed down over the cap 12 to engage the shoulder of the syringe body 6.
On activation of the syringe the [0072] hub 34 is driven downwardly relative to the end portion 26 of the socket 24 from the position shown in FIG. 11 to the position shown in FIG. 12. In the position shown in FIG. 11, the end 50 of the rubber shield 46 rests against the closure 10 so as to provide a protected contact zone, which is penetrated by the needle 44 on the hub 34 as the hub is driven downwardly through the guide 52 until a flange 35 on the bottom of the hub 34 contacts the closure 10. At this point the needle 44 establishes communication with the interior of the body 6 of the protosyringe.
FIG. 21 shows how the arrangement of FIGS. 11 and 12 (or FIGS. 19 and 20 considered below) may be used in an arrangement in which the assembly is activated by insertion of the [0073] vial 2. As best seen in FIG. 22, the component 42 is lengthened and modified so that it, the penetrable shield 54 on the cannula 40, and the cannula 40 itself, project into the vial socket 32. On insertion of the vial 2, the shield 54 is pressed into a recess in the arrangement 42 so that it is penetrated by the cannula, which also penetrates the closure of the vial 2, and the vial closure presses on the component 42 so as to drive the cannula 44 through its sheath or shield and the penetrable closure of the protosyringe. If the modification of FIGS. 19 and 20 is used, with a hub 34 modified as shown in FIG. 22 so that the flange 35 provides the overcap, this driving action also drives the overcap 35 onto the cap of the protosyringe. If the arrangement of FIGS. 11 and 12 is used, the cap of the protosyringe is already lodged in the overcap.
FIG. 13 illustrates an alternative means of driving the [0074] hub 34. The luer spigot 38 of the hub 34 is covered by a conventional moulded cover 104, shown in section in FIG. 13, screwed into the socket 36 and providing a convenient driver for the hub which can be unscrewed and discarded preparatory to fitting a needle to the luer of the hub.
FIGS. 14 and 15 illustrate an alternative driver arrangement, making use of a known type of adapter used to couple syringes to flexible mini-bags so that the contents of the syringe may be discharged into the bag and mixed with the contents of the latter. The adapter [0075] 106 consists of a tube 108 which has an internally threaded socket 118 at one end for screwing in the present case on to complementary external threads on the portion 26 of a syringe socket 24, and slots 110 at the other end to engage lugs on a nipple of the bag so that the nipple is guided into the adapter concentrically aligned with a needle 112 fitted to the spigot 38 of the hub 34. A cap 114 covers the slotted end of the tube 108, and has a concentric internal tubular extension 116 that sheathes the needle 112, and extends the socket 36 of the hub 34 when the latter is in the position shown in FIG. 11, with the tube 108 extending only part way into the cap 114. Pushing further on the cap will force the hub 34 from the position shown in FIG. 11 to the position shown in FIG. 12, thus activating the syringe. The cap 114 may then be removed, and the syringe applied to a mini-bag as shown in FIG. 16. Alternatively the tube 10 may also be removed providing a ready to use syringe.
Instead of a protosyringe in the form of a bottomless vial, the arrangement of FIGS. 11, 12, [0076] 14 and 15 may also be used to activate a regular pharmaceutical vial so that its contents may be mixed with those of a mini-bag or other flexible bag. Liquid from the flexible bag may be caused to enter the activated vial through the needle, and the admixed contents of the vial then allowed to run back into the bag through the needle by suitable manipulation of the bag and the attached activated vial.
The arrangement shown in FIGS. 11 and 12 may also be modified as shown in FIGS. 19 and 20 by extending the [0077] flange 35 of the hub 34 to form the overcap (see also FIG. 22). In order to accommodate downward movement of the overcap while preventing inward movement of the protosyringe, the reduced diameter portion of the syringe socket is extended downward as at 27 to form a shoulder limiting insertion of the protosyringe.
FIG. 23 shows a modification of the embodiment of FIGS. 17 and 18 to allow preparation of a three component pharmaceutical. The [0078] vial socket 22 is bifurcated, as is the component 42, so as to provide two vial sockets 30, and two needles which are not seen since they are covered by sheaths 54. On activation of the assembly by driving the driver 21 into the syringe socket 24, the closures of the vials will be penetrated simultaneously, enabling liquid from the protosyringe body 6 to enter both vials 2 and dissolve or suspend their contents. On activation, latch members 56 engage the component 42 to retain it, as in previous embodiments.
A [0079] further vial socket 30 and a further branch of the component 42 may be provided for each additional component to be handled.
Referring now to FIG. 24, the principles of the invention may also be utilized with protosyringes in the form of a shell vial (or as shown, the functional equivalent of a shell vial produced by reversing a [0080] bottomless vial 206 as described in U.S. Pat. No. 5,364,369A and applying a driver cap 220 to its cap end). Such shell vials are normally formed into a completed syringe by screwing a threaded extension 216 of a piston 214 into a free end of a plunger stem within a concentric syringe shell connected to the other end of the plunger. A double ended needle extends axially of the plunger stem and out of its other end. Screwing the extension 216 fully onto the plunger stem causes the needle to penetrate the piston so that the contents of the shell vial may be expelled through the needle by driving the vial onto the plunger stem. Such an arrangement is described in U.S. Pat. No. 5,171,214A already referenced above. In the present instance, a syringe socket 224 provides the shell, and the hub assembly utilized in the embodiment of FIGS. 1 -10, modified as shown in FIGS. 17 and 18, is further modified by providing an elongated cannula 244 surrounded by a concentric plunger stem 218 positioned on the cannula by passing through a flange 245 and entering the overcap 35. The length of the cannula 244 is such that it ends short of a penetrable septum (not shown) within the piston 21 with the components in the unactivated state shown in FIG. 24, with the piston extension 216 screwed into a threaded socket at the bottom of stem 218.
The assembly is activated by driving the shell vial upwardly so that a reduced [0081] diameter portion 219 of the stem 228 enters the overcap 35, permitting the cannula 244 to perforate the septum in the piston. Further upward movement causes the cannula supported at the upper end of the hub to penetrate the sheath 64 and the penetrable closure of the vial 2, whereafter activation can proceed as previously described save that the shell vial 206 is manipulated in place of a conventional plunger.
Referring now to FIG. 25, there is shown a flow diagram of the preparation of an assembly in accordance with the invention, specifically the embodiment of FIGS. 17 and 18. [0082]
Starting at the top left, the [0083] parts 34, 35, 42, 46 and 64 are assembled to form the hub assembly 300, which is then sterilized by gamma radiation (step 320). Within a clean room 314 (top right) the parts 6, 12, 14, 16 are assembled and filled to provide a protosyringe 304 to the cap of which the overcap 35 is applied, but not far enough for the cannula within the overcap 35 to penetrate the shield or sheath 46, to provide subassembly 306, which then passes through an inspection station 316.
In the [0084] meanwhile parts 21, 22 and 24 are assembled to provide a subassembly 302 and, together with the plunger 18, sterilized by gamma radiation at 322. The assembly 306 of protosyringe and hub assembly is inserted into the assembly 302 under a laminar flow hood to provide the assembly 308, whereafter, in the same environment, a vial 2, from which any protective metal disc on the cap has been flipped off, is inserted into the vial socket of the assembly 308, which corresponds exactly to that of FIG. 18. The contacting surface of the penetrable closure 58 (see FIG. 1) of the vial 2 and the surface 50 of the shield 64 are sterilized by a high intensity ultraviolet flash or an antiseptic spray 318 during this step, whereafter the resulting assembly 310 together with the plunger 18 is sealed into a plastic tray 312. The tray is vacuum formed with a recess shaped to correspond to the profile of the assembly 310. In particular, it is advantageous that this recess snugly embraces the narrower portion of the actuator 21 to avoid any possibility of inadvertent activation prior to use occasioned by shock or rough handling.
Variations are of course possible in this procedure. For example, the [0085] protosyringe 304 like the vial might be preproduced and terminally sterilized, and assembled to the hub assembly to produce the assembly 306 in a similar manner to combination of assemblies 302 and 308.
In the embodiments described above, activation of the protosyringe involves penetration of the closure of the protosyringe by a second cannula on the hub, but the invention is also applicable to protosyringes activated by other means. In U.S. Pat. No. 3,967,759 (Baldwin), there is disclosed a protosyringe in which the closure at the capped end of the body of the protosyringe is a plug lodged in an end of a tubular body, which closure is breached by ejection of the plug into a hollow interior of the cap such that the contents of the syringe may bypass the plug within the cap. [0086]
Such a protosryinge is activated by application of fluid pressure to the plug by the application in turn of longitudinal pressure to the piston of the protosyringe by a plunger, and thus the second cannula and its associated sheath is not required. [0087]
This arrangement is exemplified in FIGS. 26 and 27, in which the same reference numerals are used to identify the same parts as in FIGS. [0088] 1-8 or 17, and only the points of difference will be discussed in detail. The components shown in the left hand portions of FIG. 26, with the exception of a filter 400, are essentially identical to the corresponding components of the embodiment of FIGS. 17 and 18, but the protosyringe shown in the right hand of FIG. 26 is essentially similar to that described with reference to FIGS. 1-4 of U.S. Pat. No. 3,967,759 (Baldwin), the text and drawings of which are incorporated herein by reference, except that the piston retainer 402 pressed into the rear of the body 6 is formed without the external flange 25 shown in the Baldwin patent, and the connector 37 of the Baldwin patent is replaced by a more conventional luer connector 36, 38 forming a hub integral with the cap 12, which otherwise corresponds to the cap 31 of the Baldwin patent, and is secured to the body 6 by means of a flange 404 pressed onto the body. The plug 10 corresponds to the plug 51 of the Baldwin patent, and may be formed with ribs similar to the ribs 53 of Baldwin or other means to ensure that, once the plug moves forward from the body 6 into the cap 12, the seal formed by the plug remains broached, and liquid can bypass the plug. There are other systems known using displaceable plugs generally similar to that disclosed in the Baldwin patent but differing in detail in the means used to ensure that the plug remains bypassed once broached, and these could also be utilized.
An [0089] adaptor 400 containing a filter may be provided secured to the connector 41 on the cannula 40, the adaptor being a press fit on the luer 38, such that when the cannula 40 is captured by the detents 56 and the portion 22 is removed, the adaptor 400 discarded with the cannula 40 and the portion 22. This enables a filter, incorporated in the adaptor 400, to be utilized during transfer of liquid between the vial 2 and the protosyringe during an activation process, so that any particulate may be removed from the reconstituted pharmaceutical as it is drawn back into the protosyringe.
The activation process is generally quite similar to that previously described. Referring to FIG. 27, pressing down on the [0090] activation cap 21 causes the latter to move into the open end of the socket 24 and press the piston retainer 402 at the rear end of the body 6 so as to move the cap 12 into the overcap 26. This moves the hub assembly formed by the luer 34, adaptor 400 and cannula 40 upwardly within the sleeve 22 until the cannula 40 pierces the closure of the vial 2. The plunger 18 can then be attached to the piston 14, and on applying pressure to the plunger, the plug 10 is moved forward to broach the closure of the protosyringe at its capped end, allowing the contents of the syringe to be discharged through the cannula 40 into the vial 2. After admixture (See FIGS. 4-9), the dissolved pharmaceutical is withdrawn back into the protosyringe through the cannula 40 and the filter in adaptor 400, and the filled syringe is removed as shown in FIG. 9, leaving behind the cannula 40 and the adaptor 400 containing the filter, and presenting the luer 34 for attachment of a hypodermic needle or other injection instrumentality.
In another possible variation, the portion of [0091] cap 12 beyond the body 6 has a smaller rather than larger internal diameter than the body 6, and the plug 10 is initially lodged in that portion of the cap 12. The 44 of the FIG. I or 17 embodiment is replaced by an activator rod, and the hub is made axially movable relative to the protosyringe as in the previous embodiments, so that on actuation of the syringe, the rod is projected against the plug 10 in the cap 12 and dislodges it into the body 6 to broach the seal of the protosyringe.
FIGS. [0092] 28-30 illustrate an embodiment of a syringe device similar to that of FIGS. 26 and 27, with like reference numerals used to indicate like parts, wherein vial coupler 22 includes a first open end having a vial socket 32 for receiving the cap end of vial 2 having a penetrable closure 4, and a second open end for receiving a mounting end of syringe 66. Vial coupler 22 further includes a series of ribs 22 c formed on inner wall 22 a and extending longitudinally down the length of the vial coupler. Adaptor 400 comprises annular retaining member 401 appropriately sized for retention within a portion 23 via detents 26, 28 formed on ribs 22 c. The detents operate to impede longitudinal movement of the adapter so as to confine the adapter to portion 23 when the device is in the retracted position or “unactivated” state, as shown in FIG. 28. This in turn maintains the position of the hub and needle assembly comprising hub shoulder 42 and socket connector 41, with hollow needle or cannula 40 retained within the shoulder portion. As shown in FIG. 28, the cannula is staked within the hub shoulder providing an enlarged blunt mounting end received by adapter 400. In an exemplary embodiment, retaining member 401 also operates as a filter for trapping particulate matter traversing the passageway between syringe 66 and vial 2 when the device is in the advanced position or “activated” state (i.e. when the vial is penetrated by needle or cannula 40) resulting from a longitudinal force applied to adapter 400 of magnitude sufficient to move retaining member 401 from beyond the region confined by the detents toward vial 2 (see FIG. 29). A series of ribs 401 a formed about the circumference of retaining member 401 are adapted to slidably interlock with corresponding longitudinal ribs 22 c (best seen in the embodiment shown in FIG. 30b) extending down vial coupler 22 to prevent rotation of retaining member 401 and the needle and hub assembly. Luer 38 is formed on syringe 66 for coupling adapter 400 at externally threaded open receiving end 404 via cooperating internal threads formed on the syringe luer portion. Other well known means for releasably coupling syringe 66 to adapter 400 may be employed (e.g. press fit or snap fit). Adapter 400 further includes open receiving end 406 which is secured to socket connector 41 for establishing the passageway through the hub and needle arrangement. Other well known means for securing adapter 400 to connector 41 of the hub and needle arrangement may be employed, including for example, press fit or snap fit, adhesive coupling and the like.
[0093] Syringe 66 further includes socket 24 capable of carrying a transferable material such as a fluid for transfer between the syringe and the vial 2 through vial coupler 22. Still referring to FIGS. 28-30, the method for deploying the pharmaceutical delivery system comprises coupling luer 38 of syringe 66 to adapter 400; advancing the syringe 66 and thus the adapter 400 (and hub and needle assembly) longitudinally within the vial coupler 22 from the retracted position to the advanced position whereby the hub shoulder portion moves past the resilient pawls 56 during advancement and the tip 40 a of cannula 40 penetrates the penetrable closure on vial 2 to create fluid communication between the vial and the syringe. A plunger rod (not shown) is inserted into flange end 68 in the direction illustrated by arrow A (FIG. 29) to project the contents of the material in socket 24 into pharmaceutical vial 2. The assembly is then swilled to dissolve, mix or suspend the contents of vial 2 with that of the pharmaceutical component from the syringe. Withdrawing the plunger aspirates the contents of the vial 2 into the syringe 66, and the syringe is detached from the adapter 400 (and hub and needle assembly) by unscrewing luer 38 from adapter end 404 to provide a syringe without needle but otherwise ready for use (see FIG. 30). The bottom portion of hub shoulder 42 rests on and is retained by the top of horizontal extensions 56 b of pawls 56. Pawls 56 thus prevent retraction of the hub shoulder 42 from the advanced position, thus retaining the hub and needle assembly including the adapter within vial coupler 22.
Note that the method for deploying the pharmaceutical delivery system using a [0094] pre-filled syringe 66 described herein is applicable for both single and multi-component pharmaceutical transfer between a vial and syringe. That is, vial 2 may contain a pharmaceutical component (e.g. a fluid or powder) and the prefilled syringe may contain another pharmaceutical component (e.g. a fluid or powder). In the case of a fluid component stored in the syringe, the fluid contents of the syringe are injected into the vial (e.g. by depression of a plunger); the components are then mixed within the vial and then aspirated into the syringe (e.g. by retraction of the plunger). In the case of a powder stored in the syringe (or if no pharmaceutical component is stored in the syringe) and a fluid component stored in the vial, the syringe would contain an air or gas volume sufficient to displace the liquid contents of the vial 2 so as to facilitate transfer of the fluid contents of the vial to the syringe for mixing. Note that mixing contemplates multiple injection and/or aspiration of the contents between the syringe and the vial, as well as swilling of the contents of the vial and/or the syringe.
In a modification to the embodiment depicted in FIGS. [0095] 28-30 and described above, FIG. 28a illustrates an embodiment of a pharmaceutical transfer assembly in a retracted or “unactivated” position wherein the same reference numerals are used to describe similar parts and only the differences are described. As shown in FIG. 28a, vial coupler 22 further includes an elongated rib segment 22 b adapted for accommodating cap portion 36 of syringe 66 within the vial coupler. Rib segment 22 b is adapted to enable receipt of syringe portion 36 to provide increased stability and structural integrity upon coupling with the vial. Shoulder 22 b ₁operates to prevent further insertion or advancement of the syringe within the vial coupler 22 beyond annular sleeve top surface 36 a. FIG. 28a further shows upper portion 42 a of hub shoulder 42 is partially retained within the horizontal extensions 56 b of pawls 56 in the retracted position (rather than disposed beneath extensions 56 b as shown in FIG. 28), thereby providing further stabilization of the hub and needle assembly within the vial coupler 22.
FIG. 29[0096] a illustrates the assembly of FIG. 28a wherein syringe 66 is coupled to receiving end 404 of adapter 400 and the syringe advanced within rib segment 22 b to abut shoulder 22 b ₁, whereby the entire hub shoulder 42 moves past the resilient pawls 56 during advancement and the tip 40 a of cannula 40 penetrates the penetrable closure on vial 2 to create fluid communication between the vial and the syringe. FIG. 30a illustrates the assembly of FIG. 28a after detachment of the syringe from the adapter 400 whereby the bottom portion of hub shoulder 42 rests on and is retained by the top of horizontal extensions 56 b of pawls 56. FIG. 30b shows a plan view along lines A-A of FIG. 30a which best illustrates the meshing of longitudinal ribs 22 c extending down the inner wall of vial coupler 22 with ribs 401 a formed about the circumference of retaining member 401 to slidably interlock to prevent rotation of retaining member 401. Ribs 42 b formed on hub shoulder 42 are adapted to mesh with corresponding slots S in pawls 56 to prevent rotation of the hub shoulder and the needle and hub assembly.
[0097] Syringe 66 may be pre-attached to the vial coupler assembly during the manufacturing stage by coupling luer 38 to receiving end 404 of adapter 400. FIG. 28b shows syringe cap portion 36 disposed within rib segment 22 b in the retracted position (i.e. not advanced within rib segment 22 b so as to abut shoulder 22 b ₁as shown in FIG. 29a). In a preferred embodiment, the syringe and vial coupler assembly may be pre-attached with the vial 2 separately packaged for subsequent attachment to the assembly by the user.
FIGS. [0098] 31-33 illustrate an exemplary embodiment wherein vial coupler 312 includes retaining member or stopper 412 having a first portion in frictional engagement with the interior surface of pawls 56 and a second portion in frictional engagement with cannula 40 for maintaining the needle and hub assembly in a predetermined retracted (i.e. “unactivated”) position. Stopper 412 has at least a portion of its outer surface in contact engagement with the interior surface of resilient pawls 56. Stopper 412 is disposed adjacent to the penetrable closure of vial 2. An outer diameter of stopper 412 is sufficiently larger than the inner diameter of pawls 56 such that the stopper frictionally engages the pawls for maintaining the stopper in a predetermined position absent applying a longitudinal force to the stopper (i.e. when the assembly is in the retracted or “unactivated” position). Bore 413 is formed within a central interior portion of stopper 412 and is adapted for receiving the tip end of cannula 40. The inner diameter of the bore is sufficiently smaller than the diameter of the cannula to permit insertion of a portion of the cannula into the bore such that the bore frictionally engages the cannula, thereby maintaining the cannula and hub assembly in a predetermined position within the vial coupler as shown in FIG. 31. Bore 413 may be a blind bore, extending only partially along the longitudinal axis of the stopper, or may be originally absent from the stopper, which is penetrable by the cannula upon advancement of the hub and needle assembly in response to application of sufficient longitudinal force in the direction toward vial 2. In an exemplary embodiment, stopper 412 may be formed of an elastomeric material such as rubber or other pliable material sufficient to frictionally engage both the interior surface of pawls 56 and the exterior surface of cannula 40. Stopper 412 is sized such that both the stopper and the hub shoulder 412 can be accommodated within pawls 56 when the device is in the advanced position. Also, stopper 412 serves to limit the degree of advancement of the hub shoulder within vial coupler 12 and accordingly limits the advancement of the needle 40 into the vial. As shown in FIGS. 31-32, stopper 412 has lower portion 414 whose outer diameter is sized to frictionally engage a first interior portion 561 of pawls 56. Upper portion 416 has an outer diameter sized to frictionally engage a second interior portion 563. Stopper 412 further includes a body portion 418 of uniform diameter less than the interior diameter of pawls 56. A conical head end portion 419 extending from upper portion 416 terminates in contact engagement with the outer surface of the penetrable closure of vial 2.
[0099] Cannula 40 is retained within hub shoulder 42 coupled to socket connector 41. The cannula may either be staked within the hub assembly. In the embodiment of FIGS. 31-32, socket connector 41 is a press or friction fit onto luer 38 of syringe 66. Other connection means are contemplated, including, for example, threadingly mating socket connector 41 and luer 38. FIG. 32 illustrates the syringe coupled to the hub and needle assembly before activation. The method for deploying the pharmaceutical delivery system comprises coupling luer 38 of syringe 66 to socket connector 41; advancing the syringe 66 and the hub and needle assembly longitudinally within the vial coupler 312 such that the cannula moves through the bore formed in stopper 412 and penetrates the penetrable closure on vial 2 to create fluid communication between the vial and the syringe. The shoulder 42, attached to the cannula, also moves through the vial coupler and is captured by the pawls 56. A plunger rod inserted into flange end 68 projects the contents of the material in socket 24 into pharmaceutical vial 2, as previously described. The assembly is then swilled to dissolve, mix or suspend the contents of vial 2 with that of the pharmaceutical component from the syringe. Withdrawing the plunger aspirates the contents of the vial 2 into the syringe 66, and the syringe is decoupled from the connector 41 by detaching luer 38 to provide a syringe without needle but otherwise ready for use. The bottom portion of hub shoulder 42 rests on and is retained by the top of horizontal extensions 56 b of pawls 56. The stopper and shoulder hub and needle are retained within the vial coupler 312 by pawls 56, as shown in FIG. 33.
FIGS. 31[0100] a, 32 a and 33 a illustrate an exemplary pharmaceutical delivery system and successive stages of deployment of the system corresponding to that illustrated in FIGS. 31-33 and described above, but with the additional features as identified in FIGS. 28a, 29 a and 30 a. In particular, as shown in FIGS. 31a, 32 a, and 33 a, vial coupler 312 further includes elongated rib segment 22 b adapted for accommodating cap portion 36 of syringe 66 within the vial coupler to provide increased stability and structural integrity upon coupling with the vial. Shoulder 22 b ₁operates to prevent further insertion or advancement of the syringe within the vial coupler 312 beyond annular sleeve top surface 36 a. FIG. 31a further shows that upper portion 42 a of hub shoulder 42 is partially retained within the horizontal extensions 56 b of pawls 56 in the retracted position rather than disposed beneath extensions 56 b as shown in FIG. 31), thereby providing further stabilization of the hub and needle assembly within the vial coupler 312. It is understood that the syringe and vial coupler assembly may be pre-attached, with the vial 2 separately packaged for subsequent attachment to the assembly by the user.
FIG. 31[0101] b is a variation of the embodiment of FIG. 31a showing a fully assembled device in the retracted position. Note that the syringe and vial coupler assembly may be pre-attached, with the vial 2 separately packaged for subsequent attachment to the assembly by the user.
A modification of the assembly described above is shown in FIGS. [0102] 34-36, in which the same reference numerals are used to describe similar parts and only the differences are described. In the exemplary embodiment illustrated in FIGS. 34-36, vial coupler 512 includes retaining member or stopper 612 mounted onto a portion of cannula 40. The cannula extends longitudinally through the central interior portion of stopper 612. Retaining member 612 may be frictionally fitted onto the cannula, or alternatively, molded as a top portion of hub shoulder 42. Still further, retaining member 612 may be fixedly secured or staked onto the cannula by any well known means, such as adhesive bonding, welding, and the like. As shown in FIG. 34, the bottom surface 612 b of retaining member 612 rests on top of horizontal extensions 56 b in lower portion 518 of pawls 56 when in the retracted or “inactivated” position and is disposed adjacent to the hub shoulder and socket arrangement shown in FIG. 34. In this manner the cannula, which is coupled to the member 612, is maintained in a predetermined position prior to fluid coupling. Extended rib segment 22 b is adapted for accommodating cap portion 36 of syringe 66 within the vial coupler to provide increased stability and structural integrity upon coupling with the vial. Shoulder 22 b ₁operates to prevent further insertion or advancement of the syringe within the vial coupler 512 beyond annular sleeve top surface 36 a. FIG. 34 further shows that upper portion 42 a of hub shoulder 42 is partially retained within the horizontal extensions 56 b of pawls 56 in the retracted position, thereby providing further stabilization of the hub and needle assembly within the vial coupler 512. Retaining member 612 may be formed of a plastic or plastic-like material. The maximum diameter D of the retaining member is slightly less than the internal diameter of pawls 56 such that a clearance C exists between the retaining member and pawls for facilitating longitudinal sliding movement and guidance of the cannula as it is protracted forward (i.e. advanced) towards the vial in response to application of a longitudinal force. Retaining member 612 may also be formed of a rubber or elastomeric material, and having at least a portion of its outer surface frictionally engaged with the interior surface of pawls 56 for assisting in maintaining the cannula in a predetermined position absent applying a longitudinal force.
Upon application of a longitudinal force to [0103] socket 41 in the direction of vial 2 sufficient to overcome the resistive force of the pawls against hub shoulder 42, the stopper 612 moves with the cannula and hub assembly to the advanced position wherein the cannula tip penetrates the penetrable closure. Upon advancement, the stopper 612 is disposed in the upper portion 519 of pawls 56, as shown in FIG. 35, with the bottom portion of hub shoulder 42 resting on and retained by the top of horizontal extensions 56 b of pawls 56 in lower portion 519. Shoulder 22 b ₁abuts annular sleeve top surface 36 a to prevent further insertion or advancement of the syringe within the vial coupler 22 and accordingly limits the advancement of the needle 40 into the vial. Stopper 612 is sized such that both the stopper and the hub shoulder 42 can be accommodated within pawls 56 when the device is in the advanced position as shown in FIGS. 35-36. Upon advancement of the stopper, needle and hub assembly to the activated position and reconstitution of the pharmaceutical components in the vial 2 and syringe socket 24, the syringe is unscrewed from the connector socket and the stopper, shoulder hub and needle are retained within the vial coupler 512 by pawls 56, as shown in FIG. 36.
FIG. 34[0104] a is a variation of the embodiment of FIG. 34 showing a fully assembled device. Note that the syringe and vial coupler assembly may be pre-attached, with the vial 2 separately packaged for subsequent attachment to the assembly by the user.
FIG. 37 shows yet another embodiment of a transfer device for transferring pharmaceutical components between a vial and a syringe according to an aspect of the invention. Vial coupler [0105] 222 comprises opposing first and second open axial ends 224, 226. First open end 224 includes a flanged portion 225 adapted for engaging an end of a medicine vial 2 having a penetrable closure 4. Second open end 226 is adapted for receiving syringe 660. Retaining member 228 extending inwardly from the interior surface of vial coupler 222 operates to engage and retain protractible luer 720 within the vial coupler. Protractible luer 720 comprises a luer body having internally threaded opening 722 for threadingly mating with an enlarged blunt mounting end 734 of syringe needle 40. As shown in FIG. 37, hub portion 730 is fixedly secured to needle 40 at end 732, opposite enlarged blunt mounting end 734. Protractible luer 720 further comprises at an end opposite end 722 a female luer lock 724 having a threaded opening for releasably engaging a male luer lock (not shown) disposed beneath protective cap 380 on syringe 660. Protractible luer body 720 includes on its annular outer surface 723 a set of detents 725, 727 spaced apart from one another for enabling retaining member 228 to retain the protractible luer within the vial coupler 222 in either the retracted or advanced position.
FIG. 37 illustrates the [0106] protractible luer body 720 in the retracted position. Longitudinal arm portion 229 of retaining member 228 is sized to fit between protrusions 725, 727 (for example, snap fit) with protrusion 727 having edge 727 a serving to abut end 229 a to retain the luer in the retracted position. The method for deploying the pharmaceutical delivery system comprises coupling the male luer lock (not shown) of syringe 660 to female luer lock 724 of the protractible luer and advancing the syringe 660 longitudinally within the vial coupler 222, causing a corresponding longitudinal movement of luer 720. Tapered portion 725 b of protrusion 725 slides over arm portion 229 during advancement such that, upon completion, the arm is retained between detent edge 725 a and annular flange 723. The arm 229 serves to abut the inner annular flange shoulder 723 a to limit the degree of insertion of the syringe and accordingly the advancement of the needle 40 into the vial. Ribs 726 formed about the circumference of luer body 720 cooperate in interlocking fashion with corresponding ribs (not shown) formed on the interior of arm 229 to prevent rotation of the protractible luer assembly, as shown in FIG. 37a. Once the transfer assembly has been deployed into the advanced position, the protractible luer remains fixed within the vial coupler with arm 229 confined by flange edge 723 a and protrusion edge 725 a. Upon reconstitution of the contents of the vial and syringe socket, syringe 660 may be removed from luer 720 (by unthreading the male luer lock from end 724) and the rest of the pharmaceutical delivery system, including vial 2, and the transfer assembly including the protractible luer can be safely discarded.
Although illustrated and described herein with reference to certain specific embodiments, the present invention is nevertheless not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the spirit of the invention. [0107]

Claims

What is claimed is:

1. A syringe safety device configured to form a fluid coupling between a sealed vial and a syringe, the syringe safety device comprising: a tubular connector having opposing first and second axial open ends, the first open axial end being adapted to engage an end of a medicine vial with stopper; and a sliding joint received in the second open axial end of the tubular connector, the sliding joint having opposing first and second open axial ends and a passageway between the first and second axial open ends, the first axial open end being adapted to engage with a mounting end of a syringe needle, the second axial end of the sliding joint further being adapted to releasably engage at least a releasable needle receiver on a distal end of a barrel of a syringe without needle, the syringe being releasably removable from the sliding joint after fluid coupling with the vial through the passageway of the sliding joint without removal of the sliding joint from the tubular connector and without the needle.

2. The syringe safety device according to claim 1 further comprising a syringe needle with one pointed end and one enlarged blunt mounting end, the needle being non-releasably captured in the tubular connector with the sliding joint.

3. The syringe safety device according to claim 2 wherein the sliding joint is slidably mounted in the tubular connector and the first axial end of the sliding joint is engaged with the blunt mounting end of the enclosed needle to support and axially move the needle in the tubular connector and sufficiently to form a leak resistant fluid coupling between the blunt mounting end of the needle and the sliding joint.

4. The syringe safety device according to claim 2 wherein the first axial end of the sliding joint is configured to releasably mate with the blunt mounting end of the enclosed needle.

5. The syringe safety device according to claim 1 wherein the second axial end of the sliding joint is open and has an inner chamber exposed at the second end of the tubular connector, the inner chamber being configured to releasably receive at least a needle mount provided on the distal end of the syringe to removably mount a needle to the distal end of the syringe.

6. The syringe safety device according to claim 1 in combination with the sealed vial.

7. The combination of claim 6 wherein the syringe is prefilled with a fluid.

8. The syringe safety device according to claim 1, wherein the tubular connector includes a set of detents formed on an inner surface thereof, and wherein the sliding joint includes a retaining member disposed between the detents prior to fluid coupling for retaining the needle in a predetermined position.

9. The syringe safety device according to claim 8, wherein the retaining member comprises an in-line filter.

10. The syringe safety device according to claim 1, further comprising a retaining member mounted on the needle and operable for retaining the needle in a predetermined position prior to fluid coupling.

11. The syringe safety device according to claim 10, wherein the retaining member frictionally engages an inner surface of the tubular connector for retaining the needle in the predetermined position prior to fluid coupling.

12. The syringe safety device according to claim 10, wherein the retaining member is made of a material penetrable by the needle in response to application of a force onto the sliding joint in a longitudinal direction toward the vial.

13. The syringe safety device according to claim 11, wherein the retaining member is disposed adjacent to the vial.

14. The syringe safety device according to claim 10, wherein the retaining member is disposed adjacent to the sliding joint prior to fluid coupling.

15. The syringe safety device according to claim 2, wherein the syringe is a conventional syringe.

16. A transfer device for transferring a pharmaceutical component between a sealed vial and a syringe, comprising:

a tubular connector having opposing first and second axial open ends, the first open axial end being adapted to engage an end of a medicine vial having a penetrable closure;

a sliding joint received in the second open axial end of the tubular connector, the sliding joint having opposing first and second open axial ends and a passageway between the first and second axial open ends, the first axial open end being adapted to engage with an enlarged blunt mounting end of a syringe needle, the second axial end of the sliding joint further being adapted to releasably engage at least a releasable needle receiver on a distal end of a barrel of a conventional syringe without needle, the syringe being releasably removable from the sliding joint after coupling with the vial through the passageway of the sliding joint without removal of the sliding joint from the tubular connector and without the needle.

17. The device of claim 16, wherein the pharmaceutical component transferred comprises a fluid.

18. The device of claim 16, wherein the medicine vial contains a fluid, and wherein the sliding joint fluidly couples with the vial through the passageway of the sliding joint.

19. A transfer device for transferring fluid between a sealed vial and a syringe, comprising:

a syringe needle; and

a movable adapter disposed in the tubular connector, the adapter having opposing first and second open axial ends and a passageway between the first and second axial open ends, the first axial open end being adapted to engage with a mounting end of the syringe needle, the second axial end of the adapter further being adapted to releasably engage at least a releasable needle receiver on a distal end of a barrel of a syringe without needle, the syringe being releasably removable from the adapter after coupling with the vial through the passageway of the adapter without removal of the adapter from the tubular connector and without the needle.

20. A transfer device for transferring a pharmaceutical component from a vial to a syringe, comprising:

a tubular connector having opposing first and second axial open ends, the first open axial end being adapted to engage an end of a medicine vial having a penetrable closure, the second open end being adapted to receive a portion of a syringe;

a syringe needle; and

a protractible luer assembly having a first portion coupled to the syringe needle and a second portion for releasably coupling to the syringe, the luer assembly having a passageway for pharmaceutical component transfer therebetween, the luer assembly longitudinally protractible from a first retracted position within the tubular connector to a second advanced position, wherein in the first retracted position a retaining assembly formed on the interior of the tubular connector engages a first portion of the luer assembly and the syringe needle is contained within the tubular connector apart from the penetrable closure, and wherein in the second advanced position, advancement of the first portion of the luer assembly from the retaining assembly advances the syringe needle to pierce the penetrable closure for establishing the pharmaceutical component transfer, wherein the syringe is releasably removable from the protractible luer assembly upon completion of the pharmaceutical component transfer and the syringe needle and protractible luer is retained in said tubular connector.

21. The device of claim 20, wherein the interior of the tubular connector engages a second portion of the luer assembly when the device is in the advanced position.

22. The device of claim 20, wherein the retaining assembly comprises an arm segment extending from the interior of the tubular connector and in contact engagement with protrusions formed on the luer assembly for retaining therein.

23. A method for deploying a pharmaceutical component between a vial and a syringe, comprising:

providing a tubular transfer device having a first end receiving a medicine vial having a penetrable closure containing a pharmaceutical component, and a protractible luer assembly disposed in the interior of the transfer device, the protractible luer assembly having a first end coupled to a syringe needle, the syringe needle extending towards the first end of the tubular transfer device receiving the vial, a second end opposite the first end, and a passageway therebetween, the luer assembly protractible from a first retracted position to a second advanced position within the tubular transfer device;

coupling a portion of a syringe without needle to the second end of the protractible luer assembly of the transfer device, the syringe having a socket for accommodating another pharmaceutical component;

applying a longitudinal force through the syringe to the protractible luer assembly to advance the assembly from the first retracted position wherein the syringe needle is apart from the vial, to the second advanced position wherein the syringe needle penetrates the penetrable closure of the vial to establish a passage between the vial and the syringe through the passageway of the luer assembly, the luer assembly being retained in the second advanced position within the tubular transfer device;

transferring at least one pharmaceutical component between the vial and the syringe socket through the passage; and

detaching the portion of the syringe from the second end of the protractible luer assembly, whereby the protractible luer assembly and syringe needle is retained within the tubular transfer device upon detachment, and whereby the syringe containing the transferred at least one pharmaceutical component is presented for attachment to another syringe needle.

24. The method of claim 23, wherein the step of transferring comprises injecting a fluid from the syringe into the vial via the passage; and aspirating the contents of the vial into the syringe via the passage.

25. The method of claim 24, further comprising the step of mixing the contents of the vial after the step of injecting and before the step of aspirating.

26. The method of claim 24, further comprising mixing the contents of the syringe after the step of aspirating.

27. A transfer device for transferring a pharmaceutical component from a vial to a syringe, comprising:

a syringe needle;

a protractible luer assembly having a first portion coupled to the syringe needle and a second portion for releasably coupling to the syringe, the luer assembly having a passageway for pharmaceutical component transfer therebetween, the luer assembly longitudinally protractible from a first retracted position within the tubular connector wherein the syringe needle is contained within the tubular connector apart from the penetrable closure, to a second advanced position toward the vial, wherein the syringe needle pierces the penetrable closure for establishing the pharmaceutical component transfer via the passageway; and

means disposed in the tubular connector for retaining the protractible luer assembly including the needle within the tubular connector upon advancement of the protractible luer assembly to the advanced position and release of the second portion of the luer assembly from the syringe.