Vial adaptor and manufacturing method therefor

A vial adaptor for releasably holding a vial (1010) and releasable connection to an injector (1008) comprising: a dual-sleeved member (11) comprising a forward facing sleeve (12) and a rearward facing sleeve (16) adapted to operably engage a front end of a forward housing (1040) of said injector (1008), and comprising a vial stopper piercing member (46); and a vial engaging element (60) adapted to slidingly translate within said forward facing sleeve (12) and releasibly hold said vial (1010) in a position whereby said vial stopper piercing member (46) pierces a stopper of said vial (1010), said vial engaging element (60) adapted to allow forward movement of a plunger of said injector (1008) when said vial (1010) is in said position. In other aspects, a vial-stopper piercing spike and a method of manufacturing same is described.

FIELD OF THE INVENTION

The present invention relates to an appliance for administering a medication, in particular a vial adaptor and a vial stopper-piercing member therefor and method of manufacturing the member.

BACKGROUND OF THE INVENTION

It is conventional to store drugs, vaccines, medicaments, solutions and the like (hereinafter, “medication(s)”) in a sealed vial or other similar container for later use. Such medications may be stored in a dry or powdered form and reconstituted in liquid form for later use, by adding a solvent, for example; alternatively, the medication may be stored in a vial in a liquid form.

A conventional vial for storing medication has an open end, a radial rim surrounding the open end, a planar rim portion that overlies the vial rim, and a reduced diameter neck portion adjacent the rim. Commonly, such vials are closed by an elastomeric stopper, or other pierceable closure, which is pierced by a syringe.

Vial adaptors, which are disposed intermediate a vial and an injection device (hereinafter used interchangeably with the term “injector” or the like) are commonly used to aid in the withdrawal of medication from a vial. Such adaptors help to hold the vial; align the syringe with the vial's stopper; and avoid accidental pricking of a user's finger.

WO 2008/047372 discloses an example of an injection device for the withdrawal of medication from a vial and injection of the medication, the device including a vial adaptor and an injector.

Rigid (non-collapsible) vials require the influx of air when medication is withdrawn, to prevent the formation of a vacuum therein. For such purpose, among other purposes, vial adaptors have been developed; some of which include a bi-functional (e.g. dual-passage or dual-conduit) stopper-piercing member that pierces the vial's stopper and is designed to allow air to flow into the vial via one conduit while medication is being withdrawn via another conduit. Some vial adaptors have a filter at the air entrance of the air conduit to prevent entry of particulate matter or bacteria into the vials during the medicament withdrawal process and air influx (e.g. as disclosed in U.S. Pat. No. 5,766,147).

U.S. Pat. No. 5,766,147 also describes a bi-functional stopper-piercing member, referred to therein as a needle, depicted as grooves in the outer surface of the needle. A possible issue with such grooves is that the typically elastomeric, i.e. resilient, stopper may block or partially block the grooves. On the other hand, internal passages/conduits can be difficult to manufacture due to the small size and possibility of buckling of the mold pins creating the conduits as a result of temperature change, and/or manufacturing design, during the manufacturing process.

SUMMARY OF THE INVENTION

According to one aspect, the invention relates to an improved adaptor to aid in the activity of transferring fluid from a first container, such as a conventional medical vial having a pierceable closure or stopper, and a second container, such as an injection device (hereinafter also referred to as an “injector”) and which simultaneously allows air flow, introducing filtered atmospheric air into the vial by means of single bi-functional (dual-conduit) stopper-piercing member (hereinafter also referred to as a “spike”).

The adaptor, hereinafter also referred to as a “vial adapter” comprises two parts, an exterior part, which forms a dual sleeved housing for engaging with the injector; and an interior part (hereinafter also referred to as a “crown”) that is movable within one sleeve of the exterior part and adapted for engaging with the vial. The crown is inwardly into a sleeve of the exterior part (housing) upon inserting the vial therein.

When the vial is inserted into the crown, a plunger locking mechanism of the injector is deactivated to allow withdrawal of medication from the vial and ejection of fluid back into the vial (or into a different vial if seated properly in the adaptor). Removal of the vial from the vial adapter will move the interior part in the vial removal direction locking the plunger locking mechanism to prevent ejection of fluid from the injector.

The vial adapter provides a convenient releasable attachment mechanism intermediate the vial and injector, and additionally provides easy manipulation and use as it is activated automatically upon vial insertion and prevents the possibility of human error.

It is a particular feature of the vial adaptor of the present invention that it is useable in combination with a conventional drug vial and an appropriate injector, to prevent accidental ejection of medication at inappropriate circumstances, however allows a liquid to be withdrawn from a first vial and ejected into the same or a different vial when the vial is seated (positioned) appropriately in the adaptor.

This feature is particularly suited to the preparation of a medication prepared by withdrawing a solvent from a first vial seated in the adaptor, removing that vial from the adaptor and placing a second vial containing a solid (e.g. powder), then injecting the solvent into the second vial; which can then be withdrawn into the injector for administering the medication.

An example of such a conventional vial and appropriate injector is described in WO 2008/047372, which is incorporated herein in its entirety. The vial adaptor is typically made of a plastic material, although not limited to any particular material.

Accordingly, the invention provides a vial adaptor for releasably holding a vial and having a releasable connection to an injector comprising: a dual-sleeved member comprising a forward facing sleeve and a rearward facing sleeve adapted to operably engage a front end of a forward housing of said injector, and comprising a vial stopper piercing member; and a vial engaging element adapted to slidingly translate within said forward facing sleeve and releasably hold said vial in a position whereby said vial stopper piercing member pierces a stopper of said vial establishing fluid communication between said vial and said injector and air communication between said vial and atmosphere, said vial engaging element adapted to allow forward movement of a plunger of said injector when said vial is in said position.

According to another aspect, the present invention relates to a bi-functional stopper-piercing member (hereinafter also referred to as a “spike”) that provides a conduit for withdrawing fluid from a vial while allowing ambient air to enter to neutralize pressure in the vial via another conduit. The conduits are internal to the spike and thus cannot be blocked, or partially blocked, by an external member, such as the vial's stopper. The conduits are preferably spaced apart to the extent possible, to reduce the possibility of air, which tends to form bubbles when entering the vial, from entering the fluid withdrawal conduit. For this purpose, the ends of the conduits that pass into the vial are preferably located at different heights along the spike and face in opposite directions. Preferably, the outlet of the air conduit is adjacent the piercing end (tip) of the spike while the end of the fluid withdrawal conduit is set back from the spike's tip. At the non-piercing end of the spike there is preferably a base that aids in connecting the spike to the remainder of the vial adaptor. Typically, the conduits are parallel to each other and the longitudinal axis of the spike.

Accordingly, the present invention provides a spike adapted to pierce a vial-stopper, the spike comprising: an elongated needle with a piercing end and an opposite end; first and second spaced apart interior conduits generally parallel to the longitudinal axis of the needle, said first conduit extending from a point adjacent said piercing end to a point adjacent to or at the end of said opposite end of the needle and to an exterior surface of the spike, said second conduit extending from a point set back from said piercing end to a point adjacent to or at the end of said opposite end of the needle and to an exterior surface of the spike.

According to yet another aspect, the present invention relates to a method of producing a dual-conduit stopper-piercing member, which allows longitudinal thermal expansion and lateral stability to the mold pins that define the conduit during the molding process.

Accordingly, the present invention provides a method of producing a plastic spike with a dual interior conduits comprising: engaging a pair of molds to each other to form a mold assembly; introducing longitudinal pins between said molds; introducing lateral pins until their semi-circumferential recesses interface with said longitudinal pins; and injecting a molten polymer into said mold assembly.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following detailed description of the invention refers to the accompanying drawings. Dimensions of components and features shown in the figures are chosen for convenience or clarity of presentation and are not necessarily shown to scale. Wherever possible, the same reference numbers will be used throughout the drawings and the following description to refer to the same and like parts.

FIGS. 1 and 2illustrate elements of a prior art injection device composed of an injector1008; a typical container (herein after “drug vial” or “vial”; and designated as1010); and a vial adaptor1020for connecting between the injector and vial. For understanding the vial adaptor of the present invention, designated with reference numeral10, vial1010and injector1008will first be briefly described. It should be understood that the below described vial and injector are merely examples of a vial and an injector with which the present vial adaptor can be used.

InFIG. 1it is seen that vial1010includes a body portion1012and a neck and rim portion (partially seen), disposed below a crimped member1014for fastening an elastomeric seal (not shown) to the vial.

FIG. 1illustrates injector1008, which typically has a needle guard1030that is positioned by a compression spring1032within a forward end of a forward housing1040to engage, at a front end thereof, vial adaptor10. At each rearward most portion of free ends of arms1319of needle guard1030are upwardly and downwardly facing protrusions1344adapted to enable the release of the plunger1049from its locked orientation; detailed below. Needle guard1030is typically “right-to-left” symmetrical such that if the needle guard is turned over, upwardly and downwardly facing protrusions1344merely exchange directions with no effect on function; the oppositely facing protrusions merely easing assembly of injector1008. At each side of forward housing1040(only one side seen), near its forward end, is a vial adaptor engaging recess1041.

A syringe1046, including a rear flange1047and having a hypodermic needle1048integrally formed therewith, is engaged by a plunger1049. Syringe1046and plunger1049are typically located within forward housing1040. Syringe1046may be a conventional syringe, such as a commercially available syringe sold under the catalog designation BD-Hypak™ or may be any other suitable syringe or cartridge.

Plunger1049selectably engages a selectable driving assembly1050, which includes a selectable driving element1051and a pair of elastomeric motion damping elements1052and1054. Selectable driving assembly1050is typically at least partially seated within a rear housing1060, forward of a main compression spring1062, which is also seated within rear housing1060. Main compression spring1062provides selectable forward displacement to the selectable driving assembly1050. Selectable operation of plunger1049by selectable driving assembly1050causes the plunger1049to inject liquid contents of syringe1046through hypodermic needle1048.

Plunger1049further includes a threaded protrusion1470, which threadably engages a corresponding threaded socket (not shown) formed in a rear surface of a resilient piston1471which sealingly engages the interior of syringe1046. Rearward of threaded protrusion1470is a generally circular cylindrical portion1472having a first cross sectional radius, followed by a relatively short circular cylindrical portion1474having a second cross sectional radius greater than the first radius and defining a rearward facing shoulder1475. Rearward of portion1474is a third generally circular cylindrical portion1476having a third cross sectional radius, typically equal to the first radius. Rearward of portion1476is formed a toothed portion1477, each tooth1478thereof having a generally transverse forwardly facing portion1480and a slanted rearwardly facing portion1482. The particular shape of the teeth of toothed portion1477enables rearward movement of the plunger1049at any time, and requires a specific configuration of ejector1008in order to enable forward movement of the plunger1049. Plunger1049is typically symmetrical about a longitudinal axis1484, which, when the injector is assembled, is coaxial with a longitudinal axis A1of vial adaptor10(FIG. 3).

Rear housing1060has associated therewith an actuation button1070, operative to selectably actuate operation of selectable driving assembly1050. Within rear housing1060are seated a rear end element1080, operative to seal the rear end of the rear housing, and a plunger locking element1090, cooperative with rear end element1080and operative to lock the plunger1049when contents of the syringe1046should not be injected through needle1048.

FIG. 2depicts details of the exemplary plunger locking element1090ofFIG. 1. Plunger locking element1090includes an upright back portion1800having at a central bottom region thereof a plunger engaging protrusion1802having a curved bottom facing edge surface1804which is engageable with teeth1478of a toothed portion1477of the plunger1049(FIG. 1) to prevent the plunger1049from moving forward.

An actuation button engagement surface1806is provided on a forwardly extending protrusion1808of the top portion of plunger locking element1090. Actuation button engagement surface1806is engaged by the underside of actuation button1070(FIG. 1) and is rotated thereby about an axis1810releasing the locking of the plunger1049during actuation of the injection device.

A pair of forwardly facing protrusions1812, each having a curved forward end1814, define axis1810about which plunger locking element1090rotates during actuation of the device. These protrusions are adapted to be seated in corresponding hemispherical recesses in the rear end element1080(not seen).

A resilient leg1820extends downwardly from back portion1800, generally underneath one of forwardly facing protrusions1812and constantly urges plunger locking element1090to rotate about axis1810to a position in which plunger1049(FIG. 1) is locked (i.e. the plunger cannot move forward). When plunger locking element1090is rotated about axis1810, resilient leg1820abuts against a forward facing protrusion of the rear end element1080(FIG. 1) and the plunger1049is released. A pair of downward facing protrusions1822(only one seen), each having a slanted forwardly facing surface1824, a generally planar bottom surface1826, and a generally planar rearwardly facing surface1828, is formed on either of forwardly facing protrusions1812of the plunger locking element1090.

During operation of the injector, such as during the injection stage, upwardly facing protrusions1344of arms1319of needle guard1030(FIG. 1) align with bottom surface1826of protrusions1822, after rotation of the plunger locking element1090about axis1810, thereby releasing the plunger1049(FIG. 1).

A preferred embodiment of vial adaptor10is now described with reference toFIGS. 3-9C. Vial adaptor10includes a dual-sleeved member11designed to operably and reversibly engage injector1008, in particular the front end of needle guard1030thereof; and a vial engaging element or crown60that fits within one end of the dual facing body and is adapted to reversibly engage vial1010. It is seen that vial adaptor10is typically side-to-side symmetric about its longitudinal axis A1(FIG. 3).

Dual-sleeved member11has a generally circular cylindrical forward facing sleeve12, which is configured to enclose crown60. Sleeve12is formed with a pair of opposing leafs14(FIG. 4). Integrally formed with sleeve12, and facing in the opposite direction, is a generally rectangular cylindrical rearward facing sleeve16having curved side walls18and curved edge walls20. A pair of hinged finger engagement portions22is integrally formed within edge walls20. Side walls18are formed with rearward facing cutouts24.

Hinged finger engagement portions22each include a generally planar portion26having an outwardly curved forward end28, with a finger engagement surface30, and raised side edges32extending along both sides of portion26. An inwardly facing retaining protrusion34(FIG. 6) is located on an inwardly facing surface of a rearward end36of each finger engagement portion22. Each of inwardly facing retaining protrusions34generally correspond a left and a right side vial adaptor engaging recess1041when vial adaptor10is positioned completely and properly on the forward end of forward housing1040. A pair of integrally formed side hinges38supports planar portion26in an elongate cut out40formed in each of edge walls20.

Generally where forward facing sleeve12and rearward facing sleeve16meet, there is an internal bulkhead42having defined at its center a dual-conduit spike46, which extends forwardly. In use, a needle49of spike46punctures the elastomeric seal of vial1010(FIG. 1), to enable fluid communication between the interior of the vial and the interior of syringe1046(FIG. 1) via a medicine conduit inlet50adjacent though slightly inboard of a forward end of spike46. There is also communication between the interior of the vial and the ambient air, via an air conduit outlet52formed adjacent the tip of spike46. This communication takes place only after the vial adaptor10moves rearwardly along axis A1(FIG. 3) and hypodermic needle1048of syringe1046pierces the septum58such that the needle tip is inside lumen54.

Extending rearwardly from bulkhead42into the interior of rearward facing sleeve16is a generally cylindrical fluid passageway defining lumen54which has at a rearward end thereof a septum receiving recess56in which a septum58is located. At the other end of bulkhead42, a base57of spike46is held, typically in association with a seal59.

Crown60is adapted to correspond to and slidingly and reversibly engage with the interior of opposing leafs14of forward facing sleeve12. Crown60is in the form of a generally cylindrical sleeve-like portion whose interior configuration is adapted to correspond to crimped member1014of the vial1010, for releasably holding the vial. Crown60has an annular base62at an end thereof whereby the overall configuration of the crown is generally cup-shaped. In the center of base62is an aperture through which spike46passes.

The cylindrical sleeve-like portion of crown60is defined by three sets of parallel curved strips slightly spaced apart from each other and connected to base62. A first set of strips is a pair of opposing strips64each of which is hingedly connected to base62and has a recess or aperture66. Apertures66are adapted to releasably receive a pair of projections68each projecting from opposing hinged strips70formed in the leaves14of forward facing sleeve12of the engagement member11. Where strips64connect to base62is a chamfer72to ease sliding of projections68upon strips64prior to the projections entering into apertures66.

A second portion of the cylindrical sleeve-like portion of crown60is defined by a second pair of opposing strips74rigidly connected at base62at an intermediate point along the strips whereby each strip has an extension76extending below the base portion. The extensions76are designed so they push needle guard1030(FIG. 1) rearward when vial10is inserted into (crown60of) vial adaptor10, which in turn disengages plunger locking element1090(FIG. 1) from plunger1049(FIG. 1) to enable forward movement of the plunger.

A third portion of the cylindrical sleeve-like portion of crown60is defined by a set of four strips78, each of which is hingedly connected to base62and each of which has a dually projecting bulb80with an outwardly projecting portion83engagable with four corresponding apertures81, which are disposed adjacent the free ends of leaves14; two apertures in each leaf. Each bulb80also has an inwardly projecting portion82adapted to slide over and hold crimped member1014of vial1010.

Preferably, some or all of the strips64,74and78have one or more ribs, for example, ribs84of opposing strips74, for reinforcing those strips, if required, and easing and ensuring proper alignment of crown60within forward end12; e.g., wherein ribs84slidingly interface with wings86.

Needle49of spike46includes a longitudinal air conduit90(FIG. 7) extending from air conduit outlet52to an air conduit extension92(FIG. 5B) whereby there is a passageway between air conduit outlet52and a filter94seated in a filter housing96. Parallel to air conduit90is a medication conduit98extending from medicine conduit inlet50to lumen54.

FIGS. 10 and 11respectively showing isometric and exploded views of an assembly200of the molding parts used in a preferred embodiment of a method of manufacturing spike46. The hidden edges inFIG. 10are shown by dashed lines. Assembly200includes molds210A and210B, having structured recesses for embodying the exterior shape212(shown in dashed line font inFIG. 11) of spike46.

Assembly200includes a longitudinal pin214for the formation of longitudinal air conduit90, and a longitudinal pin216for the formation of longitudinal medication conduit98. Lateral pins218A and218B are used to form medication conduit inlet50, and lateral pins220A and220B are used to form the lateral air conduit extensions92.

The molding process is preferably performed as follows; initially, molds210A and210B are engaged to each other. Longitudinal pins214and216are then introduced into (between) molds210A and210B. Subsequently lateral pins and218A,218B,220A and220B are introduced until semi-circumferential recesses222(FIG. 11) of those pins interface with longitudinal pins214and216. A molten polymer (not shown) is thence injected into mold assembly200, and then cooled, to form bi-functional spike46.

It should be noted that pins214and216are not longitudinally constrained by molds210A and210B and lateral pins218A,218B,220A and220B whereby the possibility of deformation or buckling of conduits90and98as a result of thermal influences is reduced or prevented.

Pins214and216are typically only about0.7millimeters in diameter and hence may easily deform during the molding process, particularly during multiple repetitions of the process. In order to prevent such deformation and form air aperture52and lateral air conduit extensions92, lateral pins220A and220B are used for centering and stabilizing longitudinal pin214and lateral pins218A and218B are used for centering and stabilizing longitudinal pin216, as well as forming the medication conduit inlet50.

To elaborate on the centering and stabilizing feature of lateral pins218A,218B,220A and220B, reference is now made toFIG. 12. As seen in enlarged views A and B, lateral pins218A and220A have semi-circumferential recesses222at their tips, conforming respectively to the exterior surfaces of longitudinal pins214and216. Lateral pins218B and220B also have respectively matching semi-circumferential recesses at their tips (not visible). These semi-circumferential recesses222at the tips of the lateral pins218A,218B,220A and220B help prevent a substantial lateral displacement of the pins214and216, while allowing for axial expansion thereof, which may result from the increase in temperature during the molding process.

During use of vial adaptor10, crown60translates between two positions: a position wherein outwardly projecting potions83of bulbs80project into respective corresponding apertures81of leaves14of forward facing sleeve12, which occurs when vial1010is removed from crown60of vial adaptor10; and a position wherein projections68projecting from opposing hinged strips70slide over chamfers72and project into respective corresponding apertures66of opposing strips64, which occurs upon pushing the vial axially into the adaptor.

To withdraw medicine from vial1010using adaptor10, rearward facing sleeve16is first placed over the front portion of forward housing1040whereby inwardly facing retaining protrusions34of hinged finger engagement portions22enter recesses1041forcing hypodermic needle1048of syringe1046to pierce the septum58such that the needle tip is inside lumen54. At this point, crown60is typically in a position wherein outwardly projecting portions83of bulbs80project into respective corresponding apertures81of leaves14of forward facing sleeve12, which occurs when vial1010is removed from crown60of vial adaptor10.

Then vial1010is pushed into crown60of adaptor10causing spike46to pierce the vial's stopper. When vial1010is pushed into crown60, crimped member1014slides over inwardly projecting portion82, urging strips78to bend outward about their hinged connection with base62. Vial1010is properly seated in crown60when projections68projecting from opposing hinged strips70have slid over chamfers72and project into respective corresponding apertures66of opposing strips64. Vial1010is held in place by inwardly projecting portion82as strips78are not free to bend outward because outwardly projecting portions83interfacing with the inside of sleeves14do not allow this.

Plunger1049is then withdrawn backward to withdraw medication from vial1010, while filtered ambient air enters the vial. In this position, extensions76of opposing strips74press needle guard1030backward such that upwardly facing protrusions align with bottom surface1826resulting in plunger locking element1090pivoting about its axis1810whereby plunger engaging protrusion1802disengages from teeth1478and plunger1049can also be moved forward. If a first vial1010with a liquid (solvent or carrier) were to be replaced with a second vial, for example, a vial with a powdered medication, the liquid could be injected into the second vial, where it would dissolve the powder, and then the resulting solution could be withdrawn into syringe1046of injector1008for injection.

When vial1010is removed from crown60of vial adaptor10, the crown is returned to its initial location in that the crown is moved by inwardly projecting portions82in the neck of the vial until outwardly projecting portion83to apertures81at which point inwardly projecting portions82are released from the vial's neck. Crown60is stopped and allows the vial1010to slide out. In the process, projections68exit opening apertures66and returns to its initial location opposite chamfers72. Movement of the crown60to its initial location causes plunger1049to re-lock.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as modifications thereof which would occur to persons skilled in the art upon reading the foregoing specification and which are not in the prior art.