WO2001052920A2

WO2001052920A2 - Needleless syringe adaptor

Info

Publication number: WO2001052920A2
Application number: PCT/US2001/002111
Authority: WO
Inventors: Dahyabhai R. Patel; John M. Kay
Original assignee: Jet Medica, L.L.C.
Priority date: 2000-01-21
Filing date: 2001-01-19
Publication date: 2001-07-26
Also published as: WO2001052920A3; AU2001232912A1

Abstract

A syringe adaptor (70) for filling a needleless syringe (10) having a body (12) which defines a delivery chamber (26) and includes a discharge orifice (30) in fluid communication with the delivery chamber (26) with a prescribed dosage of a fluid medication (28) within a pre-filled syringe (72). The syringe adaptor (70) comprises a bonnet portion (82) which is releasably attachable to the body (12) of the needleless syringe (10). Extending from the bonnet portion (82) is a connector portion (88) which is sized and configured to be releasably engagable to the pre-filled syringe (72). The connector portion (88) of the syringe adaptor (70) includes an inflow aperture (96) disposed therein which is placeable into fluid communication with the discharge orifice (30) when the bonnet portion (82) is releasably attached to the body (12). The expulsion of the fluid medication (28) from the pre-filled syringe (72) subsequent to the engagement thereof to the connector portion (88) and the attachment of the bonnet portion (82) to the body (12) facilitates the transfer of the fluid medication (28) from the pre-filled syringe (72) into the delivery chamber (26) of the body (12) via the inflow aperture (96) of the syringe adaptor (70) and the discharge orifice (30) of the body (12).

Description

- i-

NEEDLELESS SYRINGE ADAPTOR

CROSS-REFERENCE TO RELATED APPLICATIONS (Not Applicable)

STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT

(Not Applicable)

BACKGROUND OF THE INVENTION The present invention relates generally to hypodermic injection devices, and more particularly to a gas pressurized, single-use needleless injection device or syringe that avoids piercing the skin by utilizing a high pressure jet to pass a medication or other substance through the skin.

In the medical profession, it is known to administer needleless medication injections through the use of "permanent gun" instruments which are generally referred to as "jet injectors". These prior art devices typically employ the use of either a compression spring or a compressed inert gas to propel fluid medication via a push rod plunger through a small orifice or opening of an injector nozzle. The injector nozzle is pressed directly against the injection site in perpendicular relation thereto, with the fluid medication generally being accelerated at a high rate of speed of between about 800 feet per second and 1,200 feet per second. This rate of speed causes the fluid medication to pierce through the skin's surface without the use of a needle, thus resulting in the fluid medication being deposited in a flower-like pattern under the skin's surface. This method of medication delivery is typically referred to in the medical profession as a subcutaneous injection. The jet injectors and similar needleless injection devices are generally perceived as reducing the relative risk and discomfort of puncturing the epidermis with a hypodermic needle, and being more easily used by persons of limited skill. Thus, the use of such devices has become of increasing interest, particularly by users such as those requiring frequent insulin injections.

Conventional jet injectors as known in the prior art are often cumbersome and awkward to use, with the preparation of a typical, reusable jet injector for administering an injection requiring several steps. More particularly, prior to each injection, the injector nozzle must be sterilized. To satisfy this need, the user removes the injector nozzle from the jet injector and boils the nozzle in water to assure a reasonable degree of sterilization. After the injector nozzle has been cleaned and sterilized, the user replaces it on the jet injector and prepares the same for loading the medication which is to be injected into the skin. A concern often associated with the injector nozzle in the prior art reusable jet injectors is that due to the relatively small opening (approximately 0.004 inches or less) , the nozzle has a tendency to clog if the jet injector is left unused for a period of time or if the user does not clean the nozzle each time after its use and prior to its reuse.

A further deficiency of prior art jet injectors is that loading the same with fluid medication is typically a time consuming and delicate operation. In a typical loading procedure, an adaptor which contains a needle is first placed through the rubber septum of a medication vial. The injector nozzle of the jet injector is then mated or coupled to the adaptor, with the user then proceeding to draw medication into the delivery chamber of the jet injector. This operation may repeated several times, until the trapped air in the delivery chamber is removed. When this pre-injection operation is complete, the user selects an injection site on the skin and administers the injection. However, a used and worn delivery orifice of the injector nozzle can slow down the delivery speed of the injected fluid medication, thus resulting in inadequate penetration and bruising of the skin at the injection site. Additionally, the improper use of jet injectors creates bruising (subdermal hematoma) when the injector nozzle is not firmly pressed against the skin at the injection site. Bruising may also occur if the orifice or^' opening of the injector nozzle is partially clogged or worn out .

With regard the prior art jet injectors employing the use of a compression spring, such compression spring propelled jet injectors are typically considered deficient in that they do not offer linear delivery speeds, i.e., a constant speed of the fluid medication being injected. Moreover, spring propelled jet injectors with weak or deteriorated springs often slow down the delivery speed of the fluid medication while the same is being administered into the skin which can result in improper fluid penetration. Reduced speed of the fluid medication delivery can also cause improper dosing and bruising at the injection site.

In recognition of the aforementioned deficiencies of jet injectors, there has been developed in the prior art single use needless injection devices or syringes, with one such injection device being described in U.S. Patent No. 4,913,699 issued to Parsons on April 3, 1990 which is owned by the Applicant. More particularly, the Parsons reference discloses a pre-sterilized disposable, single- use injection device which has its own compressed gas power source and is small and light enough for the user to carry the device along during the day. The Parsons injection device is adapted to be filled with a selected dosage of fluid medication from existing medication vials, and is operable without the need to cock a spring due to its use of compressed gas as the source of power. Though the Parsons injection device overcomes many of the deficiencies of the prior art jet injectors, it possesses its own deficiencies which detract from its overall utility. More particularly, the Parsons injection device is not provided with a structure (i.e., an adaptor) which allows the same to be quickly and easily filled with fluid medication from within an existing pre-filled syringe. In this regard, currently known in the medical field are single use syringes which are pre-filled with a prescribed dosage of a fluid medication such as insulin, and are engagable to a traditional needle hub for purposes of allowing the user to administer the fluid medication via a traditional needle stick. As will be recognized, many such users would prefer a needleless injection through the use of, for example, the Parsons injection device. However, as indicated above, the Parsons injection device does not include an adaptor which is suited to quickly and easily facilitate the transfer of the fluid medication from the pre-filled syringe thereinto. Additionally, though U.S. Patent No. 4,913,699 discloses various structures and devices which are adapted to facilitate the transfer of fluid medication from within a vial into the Parsons injection device, such structures and devices are relatively complex in their construction, and hence cumbersome to use.

The present invention overcomes these deficiencies by providing a syringe adaptor usable in conjunction with a needleless syringe and specifically suited to facilitate the transfer of a fluid medication from a pre- filled syringe into the needleless syringe in a quick and uncomplicated manner. Also provided by the present invention is a vial adaptor which is operative to facilitate the transfer of fluid medication from within a vial either into an introducer syringe or a simple, easy to use loader device, with either the introducer syringe or loader device being usable to fill the needleless syringe with the fluid medication. These, as well other features and advantages of the present invention, will be discussed in more detail below.

BRIEF SUMMARY OF THE INVENTION In accordance with the present invention, there is provided a syringe adaptor for filling a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a pre-filled syringe. The syringe adaptor comprises a bonnet portion which is releasably attachable to the body of the needleless syringe. Extending from the bonnet portion is a connector portion which is sized and configured to be releasably engagable to the pre-filled syringe. The connector portion of the syringe adaptor includes an inflow aperture disposed therein which is placeable into fluid communication with the discharge orifice when the bonnet portion is attached to the body. The expulsion of the fluid medication from the pre-filled syringe subsequent to the engagement thereof to the connector portion and the attachment of the bonnet portion to the body facilitates the transfer of the fluid medication from the pre-filled syringe into the delivery chamber via the inflow aperture and the discharge orifice. The connector portion of the syringe adaptor preferably defines a tapered bore which fluidly communicates with the bore thereof and is sized and configured to receive and frictionally engage a portion of the pre-filled syringe. In this respect, the slope of the internal surface of the connector portion which defines the bore is sized relative to the slope of that portion of the pre-filled syringe insertable into the bore such that a frictional engagement is facilitated upon the insertion of the pre-filled syringe into the bore. The bonnet portion of the syringe adaptor preferably includes internal threads formed therein so as to allow the syringe adaptor to be threadably connectable to the body of the needleless syringe due to the same typically being formed to include external threads thereon. The external threads of the body and hence the internal threads of the bonnet portion may be Luer threads. The syringe adaptor is preferably sized and configured such that the inflow aperture is in substantial coaxial alignment with the discharge orifice when the bonnet portion is attached to the body of the needleless syringe. Additionally, the pre-filled syringe may include internal threads formed therein with the connector portion of the syringe adaptor including external threads formed thereon such that the pre-filled syringe is threadably connectable to the connector portion of the syringe adaptor. The internal threads of the pre-filled syringe and the external threads of the connector portion may be Luer threads.

Further in accordance with the present invention, there is provided a vial adaptor for facilitating the transfer of a fluid medication within a vial having a cap which includes a pierceable septum into an introducer syringe. The vial adaptor comprises a bonnet portion which is releasably attachable to the cap of the vial. Extending from the bonnet portion is a connector portion which defines a bore sized and configured to receive and releasably engage a portion of the introducer syringe. In addition to the bonnet and connector portions, the vial adaptor comprises an elongate spike portion which extends within the bonnet portion and is advanceable through the septum into the vial when the bonnet portion is attached to the cap. The spike portion defines a fluid passage which communicates with the bore, and includes at least one, and preferably three flow openings formed therein, each of which fluidly communicates with the fluid passage and is normally sealed by the septum when the bonnet portion is attached to the cap. The creation of a vacuum within the introducer syringe subsequent to the attachment of the bonnet portion to the cap of the vial and the engagement of the introducer syringe to the connector portion causes the fluid medication within the vial to be drawn between the septum and the spike portion into the fluid passage via the flow opening (s) and into the introducer syringe. The bore of the vial adaptor is preferably tapered such that the connector portion is frictionally engagable to the introducer syringe.

Still further in accordance with the present invention, there is provided an alternative vial adaptor for facilitating the transfer of a fluid medication within a vial having a cap which includes a pierceable septum into a loader device. This alternative vial adaptor comprises a bonnet portion which is releasably attachable to the cap of the vial, and a connector portion which extends from the bonnet portion. The connector portion is sized and configured to be releasably engagable to the loader device, and includes an outflow aperture disposed therein which is placeable into fluid communication with the loader device. In addition to the bonnet and connector portions, this alternative vial adaptor also comprises an elongate spike portion which extends within the bonnet portion and is advanceable through the septum into the vial when the bonnet portion is attached to the cap. The spike portion defines a fluid passage which communicates with the outflow aperture, and includes at least one, and preferably three flow openings formed therein, each of which fluidly communicates with the fluid passage and is normally sealed by the septum when the bonnet portion is attached to the cap. The creation of a vacuum within the loader device subsequent to the attachment of the bonnet portion to the cap of the vial and the engagement of the loader device to the connector portion causes the fluid medication within the vial to be drawn between the septum and the spike portion into the fluid passage via the flow opening (s) and into the loader device via the outflow aperture. The connector portion of the alternative vial adaptor may be formed to include external threads thereon so as to be threadably connectable to the loader device which is typically formed to include internal threads therein. The external threads of the connector portion and the internal threads of the loader device may comprise Luer threads. The loader device itself preferably comprises a hollow, tubular sheath having opposed ends and including a coupler member disposed on one end thereof. The coupler member is preferably integrally connected to the sheath, and is releasably engagable to the connector portion of the vial adaptor. Additionally, the coupler member is sized and configured such that when engaged to the connector portion, the interior of the sheath is placed into fluid communication with the outflow aperture of the connector portion, and hence the fluid passage defined by the spike portion of the vial adaptor.

The loader device further comprises a piston member which is movably connected to the sheath and movable in a first direction away from the coupler member and a second direction toward the coupler member. More particularly, the piston member is preferably threadably connected to the sheath such that the rotation thereof in a first direction facilitates movement away from the coupler member, with rotation in a second direction opposite the first direction facilitating movement toward the coupler member. Upon the attachment of the vial adaptor to the cap of the vial and engagement of the loader device to the vial adaptor, the movement of the piston in the first direction away from the coupler member creates a vacuum within the sheath which causes the fluid medication to be drawn thereinto from the vial via the fluid passage, the outflow aperture, and the coupler member.

Once filled with the fluid medication, the loader device may be releasably connected to the barrel portion of the body of the needleless syringe, with the subsequent movement of the piston member in the second direction toward the coupler member forcing the fluid medication from within the sheath and into the delivery chamber of the body of the needleless syringe via the coupler member of the loader device and the discharge orifice of the needleless syringe body. The coupler member is preferably provided with internal threads to allow the loader device to be threadably connected to both the connector portion of the vial adaptor and the barrel portion of the body of the needleless syringe, both of which are typically formed to include complimentary external threads. Still further in accordance with the present invention, there is provided a cartridge adaptor for facilitating the transfer of a fluid medication within a cartridge having a cap which includes a pierceable septum into a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber. The cartridge adaptor comprises a bonnet portion which is advanceable over the cap of the cartridge. Extending from the bonnet portion is a connector portion of the cartridge adaptor which sized and configured to be releasably engagable to the needleless syringe. The connector portion includes an inflow opening disposed therein which is placeable into fluid communication with the discharge orifice. In addition to the bonnet and connector portions, the cartridge adaptor includes an elongate spike portion which extends within the bonnet portion and is advanceable through the septum into the cartridge when the bonnet portion is advanced over the cap. The spike portion defines a fluid passage which fluidly communicates with the inflow opening. The application of compressive pressure to the fluid medication within the cartridge subsequent to the advancement of the spike portion through the septum and the engagement of the connector portion to the needleless syringe causes the fluid medication within the cartridge to be forced into the delivery chamber via the fluid passage, the inflow opening, and the discharge orifice.

In the cartridge adaptor, the spike portion may comprise a segment of hypodermic needle tubing. Additionally, the connector portion preferably defines a bore which is sized and configured to receive and releasably engage a portion of the needleless syringe, with the inflow opening being in fluid communication with the bore. Since the body of the needleless syringe typically includes external threads formed thereon, the connector portion of the cartridge adaptor may include internal threads formed therein such that the cartridge adaptor is threadably connectable to the body of the needleless syringe. The external threads of the body and the internal threads of the connector portion may comprise Luer threads.

In certain applications, the cartridge is disposed within an injector pen. When the cartridge is disposed within the injector pen, the septum thereof is exposed and presented at a distal end of the injector pen. For this particular application, the bonnet portion of the cartridge adaptor is preferably sized and configured to receive and releasably engage a portion (i.e., the distal end portion) of the injector pen, with the spike portion being advanceable through the septum when the bonnet portion is engaged to the injector pen. The injector pen typically includes external threads formed thereon, with the bonnet portion thus preferably including internal threads formed therein such that the cartridge adaptor is threadably connectable to the injector pen. The external threads of the injector pen and the internal threads of the bonnet portion may comprise Luer threads. Still further in accordance with the present invention, there is provided a method of filling a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a pre-filled syringe. The method comprises the initial step of providing the syringe adaptor having the above-described structural and functional attributes. The bonnet portion of the syringe adaptor is attached to the body of the needleless syringe, with the pre-filled syringe then being engaged to the connector portion of the syringe adaptor. Thereafter, the fluid medication is transferred from the pre-filled syringe into the delivery chamber of the body via the inflow aperture and the discharge orifice. The bonnet portion of the syringe adaptor is preferably threadably connected to the body of the needleless syringe, with the pre-filled syringe preferably being frictionally engaged to the connector portion of the syringe adaptor. The pre-filled syringe may also be threadably connected to the connector portion of the syringe adaptor as an alternative or in addition to being frictionally engaged thereto. Still further in accordance with the present invention, there is provided a method of filling a needleless syringe having a body which defines a delivery chamber and includes the discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a cartridge of an injector pen. The method comprises the initial step of providing a cartridge adaptor having the above-described structural and functional attributes. The bonnet portion of the cartridge adaptor is attached to the injector pen, with the needleless syringe then being attached to the connector portion of the cartridge adaptor. Thereafter, the fluid medication is transferred from within the cartridge of the injector pen into the delivery chamber of the body via the fluid passage, the inflow opening, and the discharge orifice. The syringe adaptor is preferably threadably connected to both the injector pen and the body of the needleless syringe.

BRIEF DESCRIPTION OF THE DRAWINGS These, as well as other features of the present invention, will become more apparent upon reference to the drawings wherein:

Figure 1 is an exploded view illustrating the needleless syringe of the present invention with an accompanying syringe adaptor constructed in accordance with a first embodiment of the present invention and specifically suited to facilitate the transfer of fluid medication from a pre-filled syringe into the needleless syringe;

Figure 2 is a cross-sectional view taken along line 2-2 of Figure 1, illustrating the syringe adaptor of the first embodiment as releasably attached to the needleless syringe and the manner in which the pre-filled syringe is engagable to the syringe adaptor;

Figure 3 is a partial cross-sectional view of the needleless syringe, syringe adaptor of the first embodiment, and pre-filled syringe as operatively coupled to each other;

Figure 4 is an exploded view illustrating a vial adaptor constructed in accordance with a first embodiment of the present invention for facilitating the transfer of fluid medication from within a vial into an introducer syringe;

Figure 5 is a top perspective view of the vial adaptor shown in Figure 4;

Figure 6 is a cross-sectional view taken along line 6-6 of Figure 5;

Figure 7 is a cross-sectional view taken along line 7-7 of Figure 6;

Figure 8 is an exploded view illustrating a vial adaptor constructed in accordance with a second embodiment of the present invention for facilitating the transfer of fluid medication from within a vial into a loader device of the present invention;

Figure 9 is a partial cross-sectional view illustrating the vial, vial adaptor of the second embodiment, and loader device as operatively coupled to each other;

Figure 10 is a cross-sectional view of the loader device shown in Figures 8 and 9 as operatively coupled to the needleless syringe to fill the fluid medication transferred into the loader device from within the vial into the needleless syringe; Figure 11 is a top perspective view of the vial adaptor of the second embodiment shown in Figures 8 and 9;

Figure 12 is a cross-sectional view taken along line 12-12 of Figure 11;

Figure 13 is a partial side-elevational view of an alternative spike portion for the vial adaptor of the second embodiment shown in Figures 11 and 12;

Figure 14 is a top perspective view of a syringe adaptor constructed in accordance with a second embodiment of the present invention for use as an alternative to the syringe adaptor of the first embodiment shown in Figures 14-16 when a pre-filled syringe including internal threads is used in conjunction with the needleless syringe;

Figure 15 is a cross-sectional view illustrating the syringe adaptor of the second embodiment as releasably attached to the needleless syringe and the manner in which the pre-filled syringe including internal threads is engagable to the syringe adaptor;

Figure 16 is a partial cross-sectional view of the needleless syringe, syringe adaptor of the second embodiment, and pre-filled syringe shown in Figure 15 as operatively coupled to each other; Figure 17 is a cross-sectional view of a cartridge adaptor constructed in accordance with a first embodiment of the present invention;

Figure 18 is a partial cross-sectional view illustrating the manner in which the cartridge adaptor of the first embodiment shown in Figure 17 is used to facilitate the transfer of fluid medication within the cartridge of an injector pen into the needleless syringe;

Figure 19 is a cross-sectional view of a cartridge adaptor constructed in accordance with a second embodiment of the present invention;

Figure 20 is an exploded view illustrating the cartridge adaptor of the second embodiment together with the cartridge and ejector device with which it is preferably used;

Figure 21 is a cross-sectional view illustrating the manner in which the cartridge adaptor of the second embodiment is used to facilitate the transfer of fluid medication from with the cartridge into the needleless syringe upon the actuation of the ejector device;

Figure 22 is an enlargement of a portion of the cross- sectional view shown in Figure 21; Figure 23 is a cross-sectional view of a cartridge adaptor constructed in accordance with a third embodiment of the present invention; and

Figure 24 is a front elevational view of an alternative embodiment of the loader device shown in Figures 8-10.

DETAILED DESCRIPTION OF THE INVENTION As indicated above, the present invention comprises a syringe adaptor which is usable in conjunction with a needleless syringe and is specifically suited for facilitating the transfer of a fluid medication from within a pre-filled syringe into the needleless syringe. Further in accordance with the present invention, there is provided a vial adaptor for facilitating the transfer of fluid medication from within a vial into an introducer syringe, which can in turn be used to transfer the fluid medication into the present needleless syringe via the syringe adaptor. Also provided is a loader device which may be used in conjunction with a vial adaptor for purposes of transferring fluid medication from within the vial into the present needleless syringe. The structural and functional attributes of the needleless syringe, syringe adaptor, vial adaptors, and loader device will all be discussed below. NEEDLELESS SYRINGE

Referring now to the drawings, Figures 1, 2 and 10 illustrate the needleless syringe 10 constructed in accordance with the present invention. The needleless syringe 10 of the present invention constitutes an improvement over the device described in U.S. Patent No. 4,913,699, the disclosure of which is incorporated herein by reference.

The syringe 10 comprises a hollow, tubular body 12. The body 12 includes a gas storage portion 14 which defines a storage chamber 16. In addition to the gas storage portion 14, the body 12 includes an ejector portion 18 defining a piston chamber 20 which is selectively placeable into fluid communication with the storage chamber 16 and has an elongate piston 22 movably disposed therein. The piston 22 itself defines an enlarged face 23 on one end thereof. Also included in the body 12 is a barrel portion 24 defining a delivery chamber 26 for receiving a prescribed dosage or quantity of a fluid medication 28 (as seen in Figure 2), and a discharge orifice 30 which is in fluid communication with the delivery chamber 26 for allowing the fluid medication 28 to be filled thereinto and expelled or ejected therefrom. The volumetric capacity of the delivery chamber 26 is preferably in the range of from about 0.04 milliliters to about 1.0 milliliters.

In the syringe 10, the gas storage, ejector and barrel portions 14, 18, 24 of the body 12 each have a generally circular cross-sectional configuration, with the storage, piston and delivery chambers 16, 20, 26 defined thereby being disposed in coaxial alignment with each other. The body 12 is preferably formed such that the diameter of the gas storage portion 14 exceeds the diameter of the ejector portion 18, with the diameter of the ejector portion 18 exceeding the diameter of the barrel portion 24. In this regard, the gas storage portion 14 transitions into the ejector portion 18 at a first annular shoulder 32, with the ejector portion 18 transitioning into the barrel portion 24 at a second annular shoulder 34. As is apparent from Figures 1-4, in the body 12 of the syringe 10, the delivery chamber 26 is oriented relative to the piston chamber 20 such that the piston 22 is advanceable into the delivery chamber 26. As is best seen in Figures 3 and 4, the barrel portion 24 of the body 12 includes an end wall 42 which defines the distal end of the syringe 10 and has the discharge orifice 30 formed therein. Additionally, attached to the body 12 is an end cap 44 which defines the proximal end of the syringe 10. The body 12 further defines an outer surface and an inner surface having a proximal section 36, an intermediate section 38, and a distal section 40. The proximal section 36 and inner surface of the end cap 44 collectively define the storage chamber 16, with the intermediate section 38 defining the piston chamber 20 and the distal section 40 (including the inner surface of the end wall 42) defining the delivery chamber 26. Integrally connected to and extending radially from the outer surface of the ejector portion 18 of the body 12 in relative close proximity to the first shoulder 32 is a tubular projection 46 which communicates with the piston chamber 20. Additionally, disposed within the ejector portion 18 of the body 12 is a vent aperture 48 which fluidly communicates with the piston chamber 20. The use of the projection 46 and vent aperture 48 will be described in more detail below.

A portion of the outer surface of the barrel portion 24 of the body 12 adjacent the end wall 42 (i.e., adjacent the distal end of the syringe 10) may be formed to include external threads 50 for purposes of allowing the threadable engagement of a protective cap (not shown) to the body 12. As will be recognized, this protective cap is used to shield the discharge orifice 30 for purposes of maintaining the sterility thereof. Upon the removal of this protective cap from the body 12, the external threads 50 may also be used to facilitate the threadable engagement of a syringe adaptor or a loader device, which will each be described below, to the body 12 for purposes of filling the delivery chamber 26 with the fluid medication 28. To maintain the fluid medication within the delivery chamber 26 when filled thereinto, the syringe 10 is provided with a plunger member 52 which is disposed within the delivery chamber 26 and prevents the flow or migration of the fluid medication 28 into the piston chamber 20. The plunger member 52 is preferably fabricated from an inert, rubber material, and is sized and configured so as to maintain a sliding seal with the distal section 40 of the inner surface, of the body 12. Additionally, at least one face of the plunger member 52 is formed to conform to the shape of the delivery chamber 26 at the discharge orifice 30 so that no fluid medication 28 remains within the delivery chamber 26 upon the actuation of the syringe 10. The syringe 10 of the present invention is provided with a source of compressed gas which facilitates the movement of the piston 22 from within the piston chamber 20 into the delivery chamber 26 for purposes of expelling or discharging the fluid medication 28 from therewithin. The source of the compressed gas is preferably a compressed gas cartridge 54 which is disposed within the gas storage portion 14 of the body 12, and more particularly the storage chamber 16. The compressed gas cartridge 54 includes a cylindrically configured body portion 56 and an elongate quill 58 which is integrally connected to the body portion 56 and protrudes axially from one end thereof. Disposed within the compressed gas cartridge 54 is a quantity of compressed gas which is preferably carbon dioxide. The compressed gas cartridge 54 is inserted into the storage chamber 16 prior to the attachment of the end cap 44 to the body 12.

The body portion 56 is preferably sized and configured such that when inserted into the storage chamber 16, the attachment of the end cap 44 to the body 12 will facilitate the compression of the body portion 56 between an annular flange of the end cap 44 and the inner surface of the first shoulder 32, thus fixedly securing the compressed gas cartridge 54 within the gas storage portion 14. When the compressed gas cartridge 54 is properly positioned within the storage chamber 16 of the gas storage portion 14, the quill 58 extends or protrudes axially into the piston chamber 20. As will also be discussed in more detail below, the quill 58 of the compressed gas cartridge 54 is selectively fracturable and, when fractured, releases the compressed gas from within the body portion 56. Thus, the quill 58 defines a fracturable release member of the syringe 10 which, prior to its fracture, normally prevents the flow of the compressed gas from within the storage chamber 16 (i.e., from within the body portion 56 of the compressed gas cartridge 54) into the piston chamber 20.

Though not shown, the syringe 10 may be provided with a liner or sleeve which is disposed within the storage chamber 16 and extends along the proximal section 36 of the inner surface of the body 12. The liner is preferably sized such that when disposed within the storage chamber 16, it is firmly seated between the proximal section 36 and the outer surface of the body portion 56 of the compressed gas cartridge 54. The purpose of the liner is to prevent any leakage or out- gassing of the compressed gas from within the storage chamber 16, as could occur over time as a result of the permeability of the material used to fabricate the compressed gas cartridge 54. In this respect, the liner is used to maintain the "potency" of the compressed gas supply for the syringe 10, thus extending the shelf life thereof.

The syringe 10 of the present invention further comprises a trigger mechanism 62 which is removably attachable to the body 12, and more particularly the ejector portion 18 thereof. The trigger mechanism 62 itself includes an elongate stem portion 64 having an enlarged head portion 66 integrally formed on one end thereof. The stem portion 64 is insertable into the projection 46 and advanceable into the piston chamber 20 in the manner best seen in Figure 2. The advancement of the stem portion 64 into the piston chamber 20 is limited by the engagement of the end thereof opposite that including the head portion 66 formed thereon to the quill 58 of the compressed gas cartridge 54. Due to the protrusion of the projection 46 radially from the ejector portion 18 and the axial extension of the quill 58 into the piston chamber 20, the stem portion 64 extends generally perpendicularly relative to the quill 58 when advanced into the piston chamber 20 via the projection 46.

The stem portion 64 of the trigger mechanism 62 is sized such that when one end thereof is engaged to the quill 58, a gap is defined between the head portion 66 and the distal end of the projection 46. As a result, the application of compressive pressure to the exposed outer surface of the head portion 66 will facilitate the inward radial movement of the stem portion 64, with such movement being limited by the abutment of the head portion 66 against the projection 46. Such inward radial movement causes the stem portion 64 to exert a force, i.e., a moment, against the quill 58 in an amount sufficient to facilitate the fracture or breakage of the same. As indicated above, such fracture of the quill 58 facilitates the immediate release or flow of the compressed gas from within the body portion 56 into the piston chamber 20.

Since the trigger mechanism 62 of the syringe 10 is removably attachable to the body 12 thereof, the syringe 10 is well suited to being pre-filled with the fluid medication 28 due to the reduced susceptibility of the syringe 10 to accidental actuation or discharge during the process of manufacture, assembly, filling, and transport. Though the attachment of the trigger mechanism 62 to the body 12 can be deferred until the syringe 10 is ready for use, the syringe 10 is further preferably provided with a safety member 68 which prevents the actuation of the trigger mechanism 62 when the same is releasably attached to the body 12. As is seen in Figures 1, 2 and 10, the safety member 68 has an arcuate configuration, and is slidably attached to the ejector portion 18 of the body 12. The safety member 68 is preferably sized to circumvent slightly greater than one-half of the circumference the ejector portion 18 so as to be maintainable in slidable engagement thereto. The safety member 68 is moveable back and forth along the ejector portion 18 between a locked position (shown in

Figures 1, 2 and 10) and an unlocked position. When the safety member 68 is in its locked position, the stem portion 64 of the trigger mechanism 62 and a portion of the projection 46 are received into a slot therein, with the stem portion 64 being prevented from radial movement by the engagement of the head portion 66 to the safety member 68 itself. When the safety member 68 is moved to its unlocked position, the application of compressive pressure to the head portion 66 of the trigger mechanism 62 facilitates the radial movement of the stem portion 64 toward the quill 58 and fracture thereof by the force of the stem portion 64 acting thereagainst as discussed above .

In the syringe 10, a liner or sleeve may also be disposed within the delivery chamber 26 and extended along the distal section 40 of the inner surface of the body 12 for purposes of maintaining the bioavailability of the fluid medication 28 filled into the delivery chamber 26. Such liner may be formed to cover the inner surface of the end wall 42. The liner may be fabricated from an inert material which prevents interaction between the fluid medication 28 and the material used to fabricate the body 12, protects the fluid medication 28 from exposure to air in the event the material of the body 12 is permeable, and/or protects the fluid medication 28 from exposure to ultraviolet radiation in the event it is photosensitive. Having thus described the basic structural elements of the syringe 10, the preferred method of using the same will now be discussed with reference to Figures 1, 2 and 10. The syringe 10 will be filled with the fluid medication 28 through the use of either the syringe adaptor or loader device which will be described below. Thereafter, the trigger mechanism 62 is attached to the body 12 by the insertion of the stem portion 64 thereof into the projection 46 in the above-described manner. Subsequent to the insertion of the stem portion 64 into the projection 46, the end wall 42, and in particular the discharge orifice 30 formed therein, is placed into firm abutting contact with the user's skin at the desired injection site. Compressive pressure is then applied to the head portion 66 of the trigger mechanism 62 by one of the fingers of the hand of the user in which the syringe 10 is being grasped. As indicated above, this application of compressive pressure facilitates the inward radial movement of the stem portion 64 which causes it to exert a force against and ultimately fracture the quill 58 of the compressed gas cartridge 54. The fracture of the quill 58 results in the flow of the compressed gas stored within the body portion 56 of the compressed gas cartridge 54 into the piston chamber 20. The gas acts against the enlarged face 23 of the piston 22 which causes the piston 22 to be driven from the piston chamber 20 into the delivery chamber 26 in the manner shown in Figure 4. This action of the piston 22 causes the plunger member 52 to act against the fluid medication 28 in a manner forcing it out of the discharge orifice 30 as a high pressure jet. As the piston 22 moves toward the end wall 42 of the barrel portion 24, gas between the piston 22 and plunger member 52 vents through the vent aperture 48. The compressed gas is also discharged or vented between the stem portion 64 and the inner surface of the projection 46.

The enlarged face 23 of the piston 22 is preferably sized so as to have a larger surface area than the end face of the plunger member 52 against which the piston 22 acts during the discharge of the fluid medication 28 from the delivery chamber 26. This surface area differential results in more pressure being applied to the fluid medication 28 than the compressed gas applies to the face 23 of the piston 22. This pressure application may be utilized to achieve an injection pressure at the discharge orifice 30 of from about 2500-5000 psi, depending on the precise configuration employed, whereas the compressed gas may exhibit a pressure of about 840 psi at room temperature.

As indicated above, the safety member 68 may be included with the syringe 10 for purposes of preventing the accidental discharge thereof after the trigger mechanism 62 has been releasably attached to the body 12. In the event the safety member 68 is included with the syringe 10, the preferred method of using the syringe 10 includes the additional step of moving the safety member 68 from its locked position preventing the radial movement of the stem portion 64, to its unlocked position whereat the application of compressive pressure to the head portion 66 facilitates the fracture of the quill 58 by the force of the stem portion 64 acting thereagainst . As an alternative to the use of the liner within the delivery chamber 26 of the body 12, the body 12 itself may be fabricated from a material which is specifically suited to maintain the bioavailability of the fluid medication 28 filled into the delivery chamber 26. In this respect, the selected material for the body 12 may be one which prevents the exposure of the fluid medication 28 to ultraviolet radiation, one which is of low permeability to prevent the exposure of the fluid medication 28 to air, or one which is inert (e.g., a cyclic olefin copolymer) to prevent any derogatory interaction with the fluid medication 28. SYRINGE ADAPTOR

Referring now to Figures 1-3, as indicated above, many users (e.g., diabetics) of traditional needled syringes would prefer a needleless injection. To allow for such needleless injection through the use of the needleless syringe 10, the present invention includes a syringe adaptor 70 which is specifically configured to facilitate the transfer of fluid medication 28 from within a pre-filled conventional syringe 72 into the needleless syringe 10 in a manner which will be described in more detail below.

The pre-filled syringe 72, as it is currently known in the medical field, comprises a hollow, tubular body 74 which defines an open, tapered distal end 76. Disposed within the body 74 is a piston 78 having a plunger member 80 attached to one end thereof. As will be recognized, the application of compressive pressure to the piston 78 drives the plunger member 80 toward the distal end 76 which causes the fluid medication within the body 74 to be expelled from therewithin via the open distal end 76. An exemplary pre-filled syringe 72 includes a prescribed dosage of a fluid medication 28, such as insulin, within the body 74, with the distal end 76 normally being enclosed by an end cap (not shown) removably attached thereto for preventing leakage of fluid medication 28 from within the body 74. Typically, the syringe 72 is used by initially removing the end cap from the distal end 76 thereof, and thereafter engaging the distal end 76 to a traditional needle hub for purposes of allowing the user to administer the fluid medication 28 via a traditional needle stick.

The syringe adaptor 70 of the present invention comprises a generally cylindrical, annular bonnet portion 82 which preferably includes a plurality of gripping ribs or serrations 84 formed about the circumference of the outer surface thereof. Formed in the inner surface of the bonnet portion 82 are internal threads 86 which are complimentary to the external threads 50 formed on the barrel portion 24 of the body 12 of the needleless syringe 10. Thus, the threads 86 allow the syringe adaptor 70 to be threadably connected to the body 12 of the needleless syringe 10 in the manner shown in Figures 2 and 3. The threads 50, 86 may comprise Luer threads, or conventional male and female threads.

In addition to the bonnet portion 82, the syringe adaptor 70 includes a connector portion 88 which is integral with and extends axially from the bonnet portion 82. The connector portion 88 includes a bore 90 which is collectively defined by a tapered inner surface 92 and end wall 94 thereof. The bore 90 is sized to receive the distal end 76 of the pre-filled syringe 72, with the slope or taper of the inner surface 92 being sized relative to the slope or taper of the distal end 76 such that the syringe 72, and more particularly the body 74 thereof, is frictionally engagable to the syringe adaptor 70 when the distal end 76 is inserted into the bore 90. The connector portion 88 also includes an inflow aperture 96, one end of which communicates with the bore 90 at the end wall 94. The opposite end of the inflow aperture 96 communicates with the interior of the bonnet portion 82 at an arcuately contoured surface section 98 of the connector portion 88. The syringe adaptor 70 is preferably fabricated from a transparent plastic material .

Having thus described the structural attributes of the syringe adaptor 70, the preferred method of using the same to facilitate the transfer of the fluid medication 28 from within the pre-filled syringe 72 into the needleless syringe 10 will now be discussed with particular reference to Figures 1-3. Initially, the syringe adaptor 70 is releasably attached to the body 12 of the needleless syringe 10 by threadably connecting the bonnet portion 82 to the barrel portion 24 of the body 12 in the above-described manner. When the bonnet portion 82 is attached to the barrel portion 24 of the body 12, the discharge orifice 30 is coaxially aligned with the inflow aperture 96 and hence the bore 90, with a protuberance formed on the outer surface of the end wall 42 through which the discharge orifice 30 extends being seated within the arcuate surface section 98 of the connector portion 88 in the manner shown in Figure 3. The seating of the end wall 42 against the connector portion 88 of the syringe adaptor 70 creates a seal which allows for the transfer of the fluid medication from the pre-filled syringe 72 into the needleless syringe 10 with a minimal amount of leakage.

Subsequent to the releasable attachment of the syringe adaptor 70 to the body 12 of the needleless syringe 10, the pre-filled syringe 72 is releasably engaged to the syringe adaptor 70 in the above-described manner. More particularly, the end cap is removed from the distal end 76 of the body 74, with the distal end 76 thereafter being frictionally engaged to the connector portion 88 via its insertion into the bore 90. Due to the inflow aperture 96 being in fluid communication with both the bore 90 and the discharge orifice 30, the application of compressive pressure to the piston 78 forces the fluid medication 28 from within the body 74 of the syringe 72 and into the delivery chamber 26 via the inflow aperture 96 and the discharge orifice 30. Upon the fluid medication being filled into the delivery chamber 26, the syringe 72 is detached from the connector portion 88 of the syringe adaptor 70, with the bonnet portion 82 thereof then being removed (i.e., unscrewed) from the barrel portion 24 of the body 12. Thus, the syringe adaptor 70 is specifically suited to allowing the needleless syringe 10 to be filled with the fluid medication 28 within the pre-filled syringe 72 in a quick and easy manner. In this respect, it is contemplated that the needleless syringe 10, pre-filled syringe 72, and syringe adaptor 70 maybe be pre-packaged together to allow the user the option to administer a needleless injection subsequent to the transfer of the fluid medication 28 from within the syringe 72 into the needleless syringe 10 through the use of the syringe adaptor 70.

Referring now to Figures 14-16, there is depicted a syringe adaptor 70a constructed in accordance with a second embodiment of the present invention. The syringe adaptor 70a is intended for use in conjunction with a pre-filled syringe 72a which is substantially similar in structure and function to the above-described pre-filled syringe 72. However, the pre-filled syringe 72a differs from the pre-filled syringe 72 in that the body 74a thereof further includes an annular, internally threaded skirt portion 75a which extends about (i.e., circumvents) the tapered distal end 76a of the body 74a. In this respect, the distal end 76a extends axially within the skirt portion 75a.

The syringe adaptor 70a of the second embodiment is itself substantially similar in structure and function to the above-described syringe adaptor 70. In this respect, the only structural distinction between the syringe adaptor 70a and the syringe adaptor 70 is that the connector portion 88a of the syringe adaptor 70a is formed to include an integral, externally threaded region 89a which protrudes radially from the distal end thereof. The connector portion 88a defines a bore 90a which is identically configured to the above-described bore 90, and extends axially from a bonnet portion 82a which is identically configured to the above-described bonnet portion 82.

As is best seen in Figures 15 and 16, the syringe adaptor 70a of the second embodiment is specifically suited for use in conjunction with the pre-filled syringe 72a. In this respect, in addition to the body 74a being frictionally engagable to the syringe adaptor 70a when the distal end 76a is inserted into the bore 90a, the body 74a is also threadably connectable to the syringe adaptor 70a by the threadable engagement of the skirt portion 75a to the externally threaded region 89a. As will be recognized, the threads formed on the externally threaded region 89a are configured to be complimentary to those formed internally within the skirt portion 75a. Such external and internal threads may comprise Luer threads. Thus, when the syringe adaptor 70a is used, the engagement thereof to the pre-filled syringe 72a is facilitated both frictionally and through a threaded connection. As will be recognized, such threaded connection between the skirt portion 75a of the body 74a and the externally threaded region 89a prevents the accidental removal or withdraw of the distal end 76a from within the bore 90a during the process of the fluid medication 28 being transferred from within the pre- filled syringe 72a into the delivery, chamber 26 of the body 12 of the needleless syringe 10. As is also seen Figures 15 and 16, the engagement of the syringe adaptor 70a to the needleless syringe 10 is accomplished in the same manner previously described in relation to the engagement of the syringe adaptor 70 to the needleless syringe 10.

VIAL ADAPTOR

Referring now to Figures 4-7, there is depicted a vial adaptor 100 constructed in accordance with a first embodiment of the present invention which is preferably used to facilitate the transfer of fluid medication 28 within a vial 102 having a cap 104 which includes a pierceable septum into an introducer syringe 72a having a configuration identical to that of the previously described pre-filled syringe 72. In this regard, the introducer syringe 72a comprises the hollow, tubular body 74 which defines the open, tapered distal end 76. Disposed within the body 74 is the piston 78 having the plunger member 80 attached to one end thereof. The operation of the introducer syringe 72a occurs in the same manner as previously described with respect to the pre-filled syringe 72.

The vial adaptor 100 of the first embodiment comprises a generally cylindrical, annular bonnet portion 106 which is releasably attachable to the vial 102, and more particularly the cap 104 thereof. As best seen Figures 5 and 6, preferably formed within the bonnet portion 106 in equidistantly spaced relation to each other are a plurality of elongate slots 108 which extend in substantially parallel relation to the axis of the bonnet portion 106, and segregate the same into multiple segments 110 of substantially equal size. The vial adaptor 100 is preferably fabricated from a transparent plastic material, with the selected material being such that the segments 110 of the bonnet portion 106 are capable of resilient flexion. Each of the segments 110 is formed to include an integral, inwardly extending retaining lip 112 which extends along the distal edge thereof.

The vial adaptor 100 further comprises a connector portion 114 which is integral with and extends axially from the bonnet portion 106. The connector portion 114 includes a bore 116 which is collectively defined by a tapered inner surface 118 and end wall 120 thereof. The bore 116 is sized to receive the distal end 76 of the introducer syringe 72a, with the slope or taper of the inner surface 118 being sized relative to the slope or taper of the distal end 76 such that the syringe 72a, and more particularly the body 74 thereof, is frictionally engagable to the vial adaptor 100 when the distal end 76 is inserted into the bore 116. Formed on the outer surface of the connector portion 114 adjacent to the distal end thereof is an external thread 128 which is preferably a Luer thread. The vial adaptor 100 of the first embodiment further comprises an elongate spike portion 122 which extends axially from within the bonnet portion 106 and is advanceable through the septum into the interior of the vial 102 when the bonnet portion 106 of the vial adaptor 100 is attached to the cap 104. As is seen in Figures 6 and 7, the spike portion 122 defines a fluid passage 124 which communicates with the bore 116 at the end wall 120, and includes at least one, and preferably three, flow openings 126 formed therein in close proximity to the distal piercing tip thereof. Each of the flow openings 126 fluidly communicates with the fluid passage 124. The spike portion 122 is preferably sized relative to the bonnet portion 106 such that the distal piercing tip defined by the spike portion 122 does not protrude beyond the distal end of the bonnet portion 106, and more particularly the distal edges of the segments 110. Having thus described the structural attributes of the vial adaptor 100, the preferred method of using the same to facilitate the transfer of the fluid medication 28 from within the vial 102 into the introducer syringe 72a will now be discussed with particular reference to Figure 4. Initially, the vial adaptor 100 is releasably attached to the cap 104 of the vial 100. Such attachment is facilitated by advancing the spike portion 122 through the pierceable septum of the cap 104, with such advancement being continued until such time as the retaining lips 112 of the segments 110 of the bonnet portion 106 are advanced over the cap 104. As will be recognized, the flexibility of the segments 110 allows for the outward flexion thereof as is needed to allow the retaining lips 112 to be advanced over the cap 104. Such outward flexion of the segments 110 is assisted by the engagement of the cap 104 against the inwardly tapered or sloped portions of the retaining lips 112. Upon the retaining lips 112 being advanced over the cap 104, they resiliently return to their original, unflexed configurations, thus resulting in the releasable engagement of the vial adaptor 100 to the vial 102. The vial adaptor 100 is prevented from easily being removed from the cap 104 due to the upward movement of the vial 100 resulting in the retaining lips 112 engaging the cap 104. As such, the segments 110 must be flexed slightly outwardly to allow for the detachment of the vial adaptor 100 from the cap 104 of the vial 102. When the vial adaptor 100 is attached to the cap 104 of the vial 102 in the above-described manner, a substantial portion of the length of the spike portion 122 resides within the interior of the vial 102. Due to the size and configuration of the flow openings 126 within the spike portion 122, such flow openings 126 are normally sealed by the septum of the cap 104, thus substantially mitigating against leakage of the fluid medication 28 from within the vial 102. In this respect, the sealing of the flow openings 126 by the septum of the cap 104 prevents the fluid medication 28 from flowing into the fluid passage 124 and hence into the bore 116 and out of the vial adaptor 100.

Subsequent to the attachment of the vial adaptor 100 to the cap 104 of the vial 102, the introducer syringe

72a is releasably engaged to the vial adaptor 100 in the above-described manner. More particularly, the distal end 76 is frictionally engaged to the connector portion 114 via its insertion into the bore 116. Due to the fluid passage 124 being in fluid communication with the bore 116, the movement of the piston 78 and its plunger member 80 away from the distal end 76 facilitates the creation of a vacuum within the body 74 as results in the fluid medication 28 within the vial 102 being drawn between the septum and the spike portion 122 into the fluid passage 124 via the flow openings 126 and thereafter into the body 74 of the introducer syringe 72a.

Once the introducer syringe 72a has been filled with the fluid medication 28, the introducer syringe 72a is detached from the connector portion 114 of the vial adaptor 100. The filled introducer syringe 72a may then be used to fill the needleless syringe 10 with the fluid medication 28 through the use of the above-described syringe adaptor 70 in accordance with the aforementioned filling technique.

Referring now to Figures 8, 9 and 11-13 there is depicted a vial adaptor 130 constructed in accordance with a second embodiment of the present invention. The vial adaptor 130 of the second embodiment is similar in structure and function to the vial adaptor 100 of the first embodiment, and comprises a generally cylindrical, annular bonnet portion 132 which is releasably attachable to the vial 102, and more particularly the cap 104 thereof. As is best seen in Figures 11 and 12, preferably formed within the bonnet portion 132 in equidistantly spaced relation to each other are a plurality of elongate slots 134 which extend in substantially parallel relation to the axis of the bonnet portion 132, and segregate the same into multiple segments 136 of substantially equal size. The vial adaptor 130 is preferably fabricated from a transparent plastic material, with the selected material being such that the segments 136 of the bonnet portion 132 are capable of resilient flexion. Each of the segments 136 is formed to include an integral, inwardly extending retaining lip 138 which extends along the distal edge thereof.

The vial adaptor 130 further comprises a connector portion 140 which is integral with and extends axially from the bonnet portion 132. The connector portion 140 defines an outflow aperture 142, and includes an external thread 144 formed on the outer surface thereof adjacent its distal end. ^■ The thread 144 preferably comprises a Luer thread.

The vial adaptor 130 of the second embodiment further comprises an elongate spike portion 146 which extends axially within the connector and bonnet portions 140, 132. The spike portion 146 is advanceable through the septum of the cap 104 into the interior of the vial 102 when the bonnet portion 132 of the vial adaptor 130 is attached to the cap 104. As is best seen in Figure 12, the spike portion 146 defines a fluid passage 148 which communicates with the outflow aperture 142 at the distal end of the connector portion 140. The spike portion 146 also includes at least one, and preferably three, flow openings 150 formed therein in close proximity to the distal piercing tip thereof. Each of the flow openings 150 fluidly communicates with the fluid passage 148. The spike portion 146 is preferably sized relative to the bonnet portion 132 such that the distal piercing tip defined by the spike portion 146 does not protrude beyond the distal end of the bonnet portion 132. As seen in Figure 13, the spike portion 146 of the vial adaptor 130 may be formed to include external barbs 147 for purposes of maintaining the same in firm engagement to the septum of the cap 104. Though not shown, the spike portion 122 of the vial adaptor 100 of the first embodiment may also be formed to include the external barbs 147. Additionally, it is contemplated that if the spike portion 122, 146 is formed to include the external barbs 147, the vial adaptor 100,130 need not be formed to include the bonnet portion 106, 132 since the external barbs 147 create a sufficient frictional force of engagement to the septum of the cap 104 as avoids the need for secondary structures to engage the cap 104 for purposes of maintaining the vial adaptor 100, 130 in engagement thereto.

The vial adaptor 130 of the second embodiment is preferably used in conjunction with a loader device 152 which is shown in Figures 8-10. The loader device 152 comprises an elongate, tubular sheath 154. Integrally formed on one end of the sheath 154 is a generally cylindrical, annular coupler member 156. The coupler member 156 is preferably formed to include internal threads on the inner surface thereof, and gripping ribs or serrations 158 which extend about the periphery of the outer surface thereof. The internal threads formed within the coupler member 156 are adapted to be threadably engagable to the thread 144 of the connector portion 140 of the vial adaptor 130. Thus, if the thread 144 of the vial adaptor 130 is a Luer thread, the internal thread of coupler member 156 will also comprise a Luer thread. Those of ordinary skill in the art will recognize that the thread 144, as well as the internal threads of the coupler member 156, may comprise standard male and female threads. As best seen in Figure 9, the coupler member 56 defines an orifice 157, one end of which fluidly communicates with interior of the sheath 154, and the opposite end of which terminates at an arcuately contoured surface segment 158. The loader device 152 further comprises an externally threaded piston member 160 which is threadably connected to the sheath 154 and includes a plunger member 162 attached to one end thereof. In the loader device 152, the rotation of the piston member in a first (i.e., clockwise) direction facilitates the movement of the plunger member 162 toward the coupler member 156. Conversely, the rotation of the piston member 116 in a second (i.e., counter-clockwise) direction opposite the first direction facilitates the movement of the plunger member 162 away from the coupler member 156.

Having thus described the structural attributes of the vial adaptor 130 and loader device 152, the preferred method of using the same will now be discussed with specific reference to Figures 8-10.

Initially, the vial adaptor 130 is releasably attached to the cap 104 in the same manner previously described in relation to the attachment of the vial adaptor 100 of the first embodiment to the cap 104 of the vial 102. Such attachment facilitates the sealing of the flow openings 150 of the spike portion 146 by the septum in the above-described manner regarding the septum sealing the flow openings 126 of the spike portion 122 of the vial adaptor 100.

Subsequent to the attachment of the vial adaptor 130 to the cap 104 of the vial 102, the coupler member 156 of the loader device 152 is threadably connected to the connector portion 140 of the vial adaptor 130. When such threadable connection occurs, the piston member 160 is preferably oriented relative to the sheath 154 such that the plunger member 162 is disposed in close proximity to the orifice 157 of the coupler member 156. The piston member 160 is then rotated in a counter-clockwise direction to facilitate the creation of a vacuum within the interior of the sheath 154. This vacuum causes fluid medication 28 to be drawn between the septum of the cap 104 and the spike portion 146 of the vial adaptor 130 into the flow openings 150, and hence the fluid passage 148. The fluid medication 28 travels through the fluid passage 148 and into the interior of the sheath 154 via the outflow aperture 142 and orifice 157. In this regard, the outflow aperture 142 within the connector portion 140 is preferably disposed within a protuberance formed on the outer surface of the connector portion 140 and extending axially therefrom. The coupler member 56 is formed such that when threadably connected to the connector portion 140, the orifice 157 is coaxially aligned with the outflow aperture 142 and hence the fluid passage 148, with the protuberance in which the outflow aperture 142 is disposed being firmly seated against the arcuately contoured surface segment 158 defined by the coupler member 156. Such sealing creates a seal which prevents leakage during the process of fluid medication 28 being drawn from the vial 102 into the loader device 152. Upon the loader device 152, and in particular the sheath 154 thereof, being filled with the fluid medication 28, the coupler member 156 of the loader device 152 is threadably connected to the thread 50 of the needleless syringe 10 in the manner shown in Figure 10. When such threadable connection occurs, the protuberance formed on the outer surface of the end wall 42 in which the discharge orifice 30 is disposed is firmly seated against the arcuately contoured surface segment 158 of the coupler member 156 to form a substantially fluid-tight seal therebetween. The piston member 160 is then rotated in a clockwise direction so as to force the fluid medication 28 from within the sheath 154 into the delivery chamber 26 defined by the barrel portion 24 of the body 12 via the orifice 157 and discharge orifice 30 which extend in coaxial alignment with each other. Upon the fluid medication 28 being transferred from the loader device 152 into the delivery chamber 26, the coupler member 156 of the loader device

152 is detached (i.e., unscrewed) from the body 12 of the needleless syringe 10.

Referring now to Figure 24, there is depicted a loader device 152a which may be used in conjunction with the vial adaptor 130 as an alternative to the above- described loader device 152. The loader device 152a is substantially similar in structure and function to the loader device 152, and comprises an elongate, tubular sheath 154a. Integrally formed on one end of the sheath 154a is a generally cylindrical, annular coupler member 156a which is identically configured to the above- described coupler member 156. Like the coupler member 156, the coupler member 156a is formed to include internal threads on the inner surface thereof, and gripping ribs or serrations 158a which extend about the periphery of the outer surface thereof. The internal threads formed within the coupler member 156a are adapted to be threadably engagable to the thread 144 of the connector portion 140 of the vial adaptor 130. Thus, if the thread 144 of the vial adaptor 130 is a Luer thread, the internal thread of the coupler member 156a will also comprise a Luer thread. The thread 144 as well as the internal threads of the coupler member 156a may also comprise standard male and female threads. The loader device 152a further comprises a piston member 160a which is reciprocally moveable in a slidable manner within the sheath 154a. Attached to one end of the piston member 160a is a plunger member 162a. Formed on the end of the piston member 160a opposite the end having the plunger member 162a attached thereto is a handle portion 163a.

When the coupler member 156a of the loader device 152a is threadably connected to the connector portion 140 of the vial adaptor 130 after the same has been releasably attached to the cap 104, the piston member 160a is preferably oriented relative to the sheath 154a such that the plunger member 162a is disposed adjacent the coupler member 156a. Thereafter, pulling the handle portion 163a so as to withdraw the piston member 160a from within the sheath 154a facilitates the creation of a vacuum within the interior of the sheath 154a which causes fluid medication 28 to be drawn into the interior of the sheath 154a. Upon the loader device 152a, and in particular the sheath 154a thereof, being filled with the fluid medication 28, the coupler member 156a of the loader device 152a is detached from the vial adaptor 130 and threadably connected to the thread 50 of the needleless syringe 10. The subsequent application of compressive pressure to the handle portion 163a forces the piston member 160a back into the sheath 154a which results in the fluid medication 28 being transferred from within the sheath 154a of the loader device 152a into the delivery chamber 26 of the body 12 of the needleless syringe 10. Upon the fluid medication 28 being transferred from the loader device 152a into the delivery chamber 26, the coupler member 156a of the loader device 152a is detached (i.e., unscrewed) from the body 12 of the needleless syringe 10.

CARTRIDGE ADAPTOR

Referring now to Figures 17 and 18, there is depicted a cartridge adaptor 164 constructed in accordance with a first embodiment of the present invention. The cartridge adaptor 164 is particularly suited for facilitating the transfer of fluid medication 28 from within a cartridge 166 into the delivery chamber 26 of the body 12 of the needleless syringe 10. The cartridge 166 comprises an elongate, tubular body 168 having a cap 170 attached to one end thereof. The cap 170 itself includes a pierceable septum 172. Disposed within the body 168 is a rubber stopper member 174 which prevents the leakage of the fluid medication 28 from within the body 168. In this respect, the fluid medication 28 is maintained between the stopper member 174 and the septum 172 of the cap 170. It is contemplated that the cartridge adaptor 164 of the first embodiment will be employed when the cartridge 166 is disposed within an injector pen 176 which is commonly referred to as an "insulin pen". The injector pen 176 comprises an elongate, tubular housing 178, the outer surface of which includes external threads 80 at one end thereof. Movably disposed within the interior of the housing 178 is a plunger member 182. The cartridge 166 is insertable into the interior of the housing 178, and positionable therewithin such that the septum 172 of the cap 170 is presented or exposed at that end of the housing 178 including the threads 180 formed thereon. Additionally, when the cartridge 166 is operatively positioned within the housing 178, the plunger member 182 is advanceable into the interior of the body 168 of the cartridge 166, and engagable to the stopper member 174. The application of compressive pressure to an actuator member 184 of the injector pen 176 causes the plunger member 182 to act against the stopper member 174 in a manner pressurizing the fluid medication 28 within the body 168 of the cartridge 166. This application of pressure to the fluid medication 28 may be used to facilitate the transfer of the fluid medication 28 from within the cartridge 166 into the needleless syringe 10 through the use of the cartridge adaptor 164 in a manner which will be discussed in more detail below.

Referring now to Figure 17, the cartridge adaptor 164 of the first embodiment comprises a generally cylindrical, annular bonnet portion 186 which is specifically configured to be releasably attachable to the housing 178 of the injector pen 176, and more particularly to the threads 180 formed thereon. In this respect, the bonnet portion 186 is preferably provided with internal threads so as to be threadably connectable to the threads 180 of the housing 178. The internal threads of the bonnet portion 186 and threads 180 of the housing 178 may comprise Luer threads.

The cartridge adaptor 164 further comprises a generally cylindrical, annular connector portion 188 which is integral with and extends axially from the bonnet portion 186. The connector portion 188 includes a bore 190 which is sized to receive a distal end of the barrel portion 24 of the body 12, including the end wall 42 having the discharge orifice 30 formed therein. The connector portion 188 also includes an inflow opening 192, one end of which communicates with the interior of the bonnet portion 186 at an end wall 194. The opposite end of the inflow opening 192 communicates with the bore 190 at an arcuately contoured surface section 196 of the connector portion 188. The connector portion 188 is preferably internally threaded so as to be threadably connectable to the body 12 of the needleless syringe 10, and more particularly to the external threads 50 formed on the outer surface of the barrel portion 24 adjacent the end wall 42. The internal threads of the connector portion 188 may be Luer threads if the external threads 50 are Luer threads. The cartridge adaptor 164 is preferably fabricated from a transparent plastic material.

In addition to the bonnet and connector portions 186, 188, the cartridge adaptor 164 includes a spike portion 198 which is attached to the connector portion 188 and protrudes from the end wall 194 thereof into the interior of the bonnet portion 186. The spike portion

198 defines a beveled distal piercing tip 200. The spike portion 198 preferably extends within the inflow opening 192 such that the end thereof opposite the piercing tip 200 terminates at the arcuately contoured surface section 196 of the connector portion 188. The spike portion 198 is preferably fabricated from a segment of metal hypodermic needle tubing. However, those of ordinary skill in the art will recognize that the syringe adaptor 164, rather than including the metal spike portion 198, may be formed to include an integral spike portion similar to that previously described in relation to the vial adaptors 100, 130. Having thus described the structural attributes of the cartridge adaptor 164 of the first embodiment, the preferred method of using the same to facilitate the transfer of the fluid medication 28 from within the injector pen 176 into the needleless syringe 10 will be now be discussed with particular reference to Figure 18. As indicated above, the cartridge adaptor 164 will typically be used in conjunction with the injector pen 176 having the cartridge 166 loaded thereinto. Initially, the cartridge adaptor 164 is releasably attached to the body 12 of the needleless syringe 10 by threadably connecting the connector portion 188 to the barrel portion 24 of the body 12 in the above-described manner. When the connector portion 188 is attached to the barrel portion 24 of the body 12, the discharge orifice 30 is coaxially aligned with the inflow opening

192, with the protuberance formed on the outer surface of the end wall 42 through which the discharge orifice 30 extends being seated within the arcuate surface section 196 of the connector portion 188 in the manner shown in Figure 18. The seating of the end wall 42 against the connector portion 188 of the cartridge adaptor 164 creates a seal which allows for the transfer of the fluid medication 28 from the injector pen 176 into the needleless syringe 10 with a minimal amount of leakage. Subsequent to the releasable attachment of the cartridge adaptor 164 to the body 12 of the needleless syringe 10, the injector pen 176 is releasably engaged to the cartridge adaptor 164 in the above described manner. More particularly, the spike portion 198 is advanced into the exposed septum 172 of the cap 170 of the cartridge 166, with the threads 180 of the housing 178 thereafter being threadably engaged to the internal threads within the bonnet portion 186. Thus, both the needleless syringe 10 and injector pen 176 are prevented from being inadvertently disconnected 'or separated from the cartridge adaptor 164 due to their threaded connection thereto. Upon the injector pen 176 being threadably connected to the cartridge adaptor 164, compressive pressure is applied to the actuator member 184 of the injector pen 176, thus causing the plunger member 182 to act against the stopper member 174 which in turn forces the fluid medication 28 from within the body 168 of the cartridge 166 into the delivery chamber 26 of the body 12 via the spike portion 198 and discharge orifice 30. This flow path may also include a section of the inflow opening 192. Those of ordinary skill in the art will recognize that the connection of the cartridge adaptor 164 to the housing 178 of the injector pen 176 may be completed prior to the threadable connection of the cartridge adaptor 164 to the body 12 of the needleless syringe 10.

Referring now to Figures 19-22, there is depicted a cartridge adaptor 202 constructed in accordance with a second embodiment of the present invention. The cartridge adaptor 202 of the second embodiment is structurally and functionally similar to the cartridge adaptor 164 of the first embodiment, and includes a connector portion 204 which is identically configured to the above-described connector portion 188, and thus is specifically adapted to be threadably connectable to the body 12 of the needleless syringe 10. The cartridge adaptor 202 of the second embodiment also includes a spike portion 206 which is identically configured to the above-described spike portion 198 of the cartridge adaptor 164, and defines a beveled distal piercing tip 208. The spike portion 206 is advanced into the inflow opening 210 of the connector portion 204 and protrudes from the end wall 212 of the connector portion 204. The end of the spike portion 206 opposite that defining the distal piercing tip 208 preferably terminates at an arcuately contoured surface section 214 of the connector portion 204. Though the spike portion 206 is preferably fabricated from a segment of metal hypodermic needle tubing, it may alternatively be integrally connected to the connector portion 204 similar to the spike portions 122, 146 previously described in relation to the vial adaptors 100, 130.

In addition to the connector portion 204 and spike portion 206, the cartridge adaptor 202 of the second embodiment comprises a bonnet portion 216 which is identically configured to the above-described bonnet portions 106, 132 of the vial adaptors 100, 130. In this respect, formed within the bonnet portion 216 are a plurality of elongate slots 218 which extend in substantially parallel relation to the axis of the bonnet portion 216, and segregate the same into multiple segments 220 of substantially equal size. The cartridge adaptor 202 is preferably fabricated from a transparent plastic material, with the selected material being such that the segments 220 are capable of resilient flexion. Each of the segments 220 is formed to include an integral, inwardly extending retaining lip 222 which extends along the distal edge thereof.

Referring now to Figures 20-22, the cartridge adaptor 202 of the second embodiment is preferably used to facilitate the transfer of fluid medication 28 from within the above-described cartridge 166 into the delivery chamber 26 of body 12 of the needleless syringe 10 when the cartridge 166 is not disposed within a device such as the above-described injector pen 176. As such, the cartridge adaptor 202 of the second embodiment is preferably used in conjunction with an ejector device 224 which comprises an elongate, tubular sheath 226. Integrally formed on one end of the sheath 226 is an enlarged flange 228. The ejector device 224 further comprises an externally threaded piston member 230 which is threadably connected to that end of the sheath 226 opposite the end including the flange 228 formed thereon. In the ejector device 224, the rotation of the piston member 230 in a first (i.e., clockwise) direction facilitates the movement of the piston member 230 toward the flange 228. Conversely, the rotation of the piston member 230 in a second (i.e., counter-clockwise) direction opposite the first direction facilitates the movement of the piston member 230 away from the flange 228. The piston member 230 is sized and configured to be advanceable into the body 168 of the cartridge 166 for reasons which will be discussed in more detail below. Having thus described the structural attributes of the cartridge adaptor 202 and ejector device 224, the preferred method of using the same will now be discussed with specific reference to Figures 21 and 22. Initially, the cartridge 166 is inserted into the interior of the sheath 226 of the ejector device 224 such that the cap 170 is circumvented by the flange 228. When the cartridge 166 is properly positioned within the sheath 226, the piston member 230 extends into the body 168 of the cartridge 166. Thereafter, the spike portion 206 of the cartridge adaptor 202 is advanced into and through the septum 172 of the cap 170, with the bonnet portion 216 of the cartridge adaptor 202 concurrently being advanced over the flange 228 of the sheath 226. The advancement of the spike portion 206 into the interior of the body 168 of the cartridge 166 is continued until such time as the retaining lips 222 of the segments 220 are advanced over the flange 228. As will be recognized, the flexibility of the segments 220 allows for the outward flexion thereof as is needed to allow the retaining lips 222 to be advanced over the flange 228. Upon the retaining lips 222 being advanced over the flange 228, they resiliently return to their original, unflexed configurations, thus resulting in the releasable engagement of the cartridge adaptor 202 to the ejector device 224. The cartridge adaptor 202 is prevented from easily being removed from the ejector device 224 due to the engagement of the retaining lips 222 to the flange 228. Indeed, the segments 220 must be flexed slightly outwardly to allow for the detachment of the cartridge adaptor 202 from the ejector device 224.

Subsequent to the engagement of the cartridge adaptor 202 to the cartridge 166 and ejector device 224 in the above-described manner, the cartridge adaptor 202 is releasably attached to the body 12 of the needleless syringe 10 by threadably connecting the connector portion 204 to the barrel portion 24 of the body 12 in the above- described manner. When the connector portion 204 is attached to the barrel portion 24 of the body 12, the discharge orifice 30 is coaxially aligned with the inflow opening 210, with the protuberance formed on the outer surface of the end wall 42 through which the discharge orifice 30 extends being seated within the arcuate surface section 214 in the manner best shown in Figure 22.

Upon the threaded connection of the cartridge adaptor 202 to the needleless syringe 10, the rotation of the piston member 230 of the ejector device 224 in a clockwise direction causes the piston member 230 of the ejector device 224 to act against the stopper member 174, which in turn causes the fluid medication 28 to be forced from within the body 168 of the cartridge 166 into the delivery chamber 26 of the body 12 via the spike portion 206 and discharge orifice 30. This flow path may also include a section of the inflow opening 210. Subsequent to the completion of this fluid transfer, the cartridge adaptor 202 is detached (i.e., unscrewed) from the body 12 of the needleless syringe 10. Referring now to Figure 23, there is depicted a cartridge adaptor 232 constructed in accordance with a third embodiment of the present invention. The cartridge adaptor 232 is similar in structure to the above- described vial adaptor 130 of the second embodiment, and comprises a cylindrically configured bonnet portion 234. In addition to the bonnet portion 234, the cartridge adaptor 232 comprises a connector portion 236 which is integral with and extends axially from the bonnet portion 234. The connector portion 236 is identically configured to the connector portion 140 of the above-described vial adaptor 130, and defines an outflow aperture 238. The connector portion 236 also includes an external thread 240 formed on the outer surface thereof adjacent its distal end. The thread 240 may comprise a Luer thread. The cartridge adaptor 232 of the third embodiment further comprises an elongate spike portion 242 which is identically configured to the spike portion 146 of the vial adaptor 130 and extends axially within the connector and bonnet portions 236, 234. The spike portion 242 defines a fluid passage 246 which communicates with the outflow aperture 238 at the distal end of the connector portion 236. The bonnet portion 234 is preferably sized so as to extend beyond the distal end of the spike portion 242.

Additional modifications and improvements of the present invention may also be apparent to those of ordinary skill in the art. As such, the parts described and illustrated herein are intended to represent only certain embodiments of the present invention, and are not intended to serve as limitations of alternative devices within the spirit and scope of the invention.

Claims

CLAIMS :

1. A syringe adaptor for filling a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a pre-filled syringe, the syringe adaptor comprising: a bonnet portion releasably attachable to the body of the needleless syringe; and a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the pre- filled syringe and including an inflow aperture disposed therein which is placeable into fluid communication with the discharge orifice when the bonnet portion is attached to the body; wherein the expulsion of the fluid medication from the pre-filled syringe subsequent to the engagement thereof to the connector portion and the attachment of the bonnet portion to the body facilitates the transfer of the fluid medication from the pre-filled syringe into the delivery chamber via the inflow aperture and the discharge orifice.

2. The syringe adaptor of Claim 1 wherein the connector portion defines a bore sized and configured to receive and releasably engage a portion of the pre-filled syringe, the inflow aperture being in fluid communication with the bore.

3. The syringe adaptor of Claim 2 wherein the bore is tapered such that the connector portion is frictionally engagable to the pre-filled syringe.

4. The syringe adaptor of Claim 3 wherein the body includes external threads formed thereon and the bonnet portion includes internal threads formed therein such that the syringe adaptor is threadably connectable to the body of the needleless syringe.

5. The syringe adaptor of Claim 4 wherein the external threads of the body and the internal threads of the bonnet portion are Luer threads.

6. The adaptor of Claim 1 wherein the connector portion of the syringe adaptor is sized and configured such that the inflow aperture is in substantial coaxial alignment with the discharge orifice when the bonnet portion is attached to the body of the needleless syringe.

7. The syringe adaptor of Claim 1 wherein a portion of the pre-filled syringe includes internal threads formed therein and the connector portion includes external threads formed thereon such that the pre-filled syringe is threadably connectable to the connector portion of the syringe adaptor.

8. The syringe adaptor of Claim 7 wherein the internal threads of the pre-filled syringe and the external threads of the connector portion are Luer threads .

9. The syringe adaptor of Claim 7 wherein the connector portion defines a tapered bore which is sized and configured to receive and frictionally engage a portion of the pre-filled syringe, the inflow aperture being in fluid communication with the bore.

10. In combination: a needless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber; a prepared syringe pre-filled with a prescribed dosage of a fluid medication; and a syringe adaptor for transferring the fluid medication from within the prepared syringe into the needleless syringe, the syringe adaptor comprising: a bonnet portion releasably attachable to the body of the needleless syringe; and a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the prepared syringe and including an inflow aperture disposed therein which is placeable into fluid communication with the discharge orifice when the bonnet portion is attached to the body; wherein the expulsion of the fluid medication from the pre-filled prepared syringe subsequent to the engagement thereof to the connector portion and the attachment of the bonnet portion to the body facilitates the transfer of the fluid medication from the prepared syringe into the delivery chamber via the inflow aperture and the discharge orifice.

11. The combination of Claim 10 wherein the connector portion of the syringe adaptor defines a bore sized and configured to receive and releasably engage a portion of the prepared syringe, the inflow aperture being in fluid communication with the bore.

12. The combination of Claim 11 wherein the bore is tapered such that the connector portion is frictionally engagable to the prepared syringe.

13. The combination of Claim 12 wherein the body includes external threads formed thereon and the bonnet portion includes internal threads formed therein such that the syringe adaptor is threadably connectable to the body of the needleless syringe.

14. The combination of Claim 13 wherein the external threads of the body and the internal threads of the bonnet portion are Luer threads .

15. The combination of Claim 10 wherein a portion of the prepared syringe includes internal threads formed therein and the connector portion includes external threads formed thereon such that the prepared syringe is threadably connectable to the connector portion of the syringe adaptor.

16. The combination of Claim 15 wherein the internal threads of the prepared syringe and the external threads of the connector portion are Luer threads .

17. The combination of Claim 15 wherein the connector portion defines a tapered bore which is sized and configured to receive and frictionally engage a portion of the prepared syringe, the inflow aperture being in fluid communication with the bore.

18. A method of filling a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a pre-filled syringe, the method comprising the steps of:

(a) providing a syringe adaptor comprising: a bonnet portion releasably attachable to the body of the needleless syringe; and a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the pre-filled syringe and including an inflow aperture disposed therein which is placeable into fluid communication with the discharge orifice when the bonnet portion is attached to the body;

(b) attaching the bonnet portion of the syringe adaptor to the body of the needleless syringe;

(c) engaging the pre-filled syringe to the connector portion of the syringe adaptor; and

(d) transferring the fluid medication from the pre-filled syringe into the delivery chamber of the body via the inflow aperture and the discharge orifice.

19. The method of Claim 18 wherein the body includes external threads formed thereon, the bonnet portion of the syringe adaptor includes internal threads formed therein, and step (b) comprises threadably connecting the syringe adaptor to the body.

20. The method of Claim 18 wherein the connector portion of the syringe adaptor defines a tapered bore which is sized and configured to receive and frictionally engage a portion of the pre-filled syringe, and step (c) comprises frictionally engaging the pre-filled syringe to the connector portion of the syringe adaptor by inserting a portion of the pre-filled syringe into the bore.

21. The method of Claim 18 wherein a portion of the pre-filled syringe includes internal threads formed therein, the connector portion of the syringe adaptor includes external threads formed thereon, and step (c) comprises threadably connecting the pre-filled syringe to the connector portion of the syringe adaptor.

22. The method of Claim 21 wherein the connector portion of the syringe adaptor defines a tapered bore which is sized and configured to receive and frictionally engage a portion of the pre-filled syringe, and step (c) further comprises frictionally engaging the pre-filled syringe to the connector portion of the syringe adaptor by inserting a portion of the pre-filled syringe into the bore .

23. A method of administering an injection through the use of a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber, the method comprising the steps of: (a) providing a syringe pre-filled with a prescribed dosage of a fluid medication;

(b) providing a syringe adaptor comprising: a bonnet portion releasably attachable to the body of the needleless syringe; and a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the pre-filled syringe and placeable into fluid communication with the discharge orifice when the bonnet portion is attached to the body; (c) attaching the bonnet portion of the syringe adaptor to the body of the needleless syringe;

(d) engaging the pre-filled syringe to the connector portion of the syringe adaptor; and

(e) transferring the fluid medication from the pre-filled syringe into the delivery chamber of the body via the discharge orifice.

24. The method of Claim 23 wherein the body includes external threads formed thereon, the bonnet portion of the syringe adaptor includes internal threads formed therein, and step (c) comprises threadably connecting the syringe adaptor to the body.

25. The method of Claim 23 wherein the connector portion of the syringe adaptor defines a tapered bore which is sized and configured to receive and frictionally engage a portion of the pre-filled syringe, and step (d) comprises frictionally engaging the pre-filled syringe to the connector portion of the syringe adaptor by inserting a portion of the pre-filled syringe into the bore.

26. The method of Claim 23 wherein a portion of the pre-filled syringe includes internal threads formed therein, the connector portion of the syringe adaptor includes external threads formed thereon, and step (d) comprises threadably connecting the pre-filled syringe to the connector portion of the syringe adaptor.

27. The method of Claim 26 wherein the connector portion of the syringe adaptor defines a tapered bore which is sized and configured to receive and frictionally engage a portion of the pre-filled syringe, and step (d) further comprises frictionally engaging the pre-filled syringe to the connector portion of the syringe adaptor by inserting a portion of the pre-filled syringe into the bore .

28. A vial adaptor for facilitating the transfer of a fluid medication within a vial having a cap which includes a pierceable septum into an introducer syringe, the vial adaptor comprising: a bonnet portion releasably attachable to the cap of the vial; a connector portion extending from the bonnet portion, the connector portion defining a bore sized and configured to receive and releasably engage a portion of the introducer syringe; and an elongate spike portion extending within the bonnet portion and advanceable through the septum into the vial when the bonnet portion is attached to the cap, the spike portion defining a fluid passage which fluidly communicates with the bore and is normally sealed by the septum when the bonnet portion is attached to the cap; wherein the creation of a vacuum within the introducer syringe subsequent to the attachment of the bonnet portion to the cap of the vial and the engagement of the introducer syringe to the connector portion causes the fluid medication within the vial to be drawn between the septum and the spike portion into the fluid passage and into the introducer syringe.

29. The vial adaptor of Claim 28 wherein the bore is tapered such that the connector portion is frictionally engagable to the introducer syringe.

30. The vial adaptor of Claim 28 wherein the spike portion includes three flow openings formed therein which each fluidly communicate with the fluid passage and are normally sealed by the septum when the bonnet portion is attached to the cap.

31. A vial adaptor for facilitating the transfer of a fluid medication within a vial having a cap which includes a pierceable septum into a loader device, the vial adaptor comprising: a bonnet portion releasably attachable to the cap of the vial; a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the loader device and including an outflow aperture disposed therein which is placeable into fluid communication with the loader device; and an elongate spike portion extending within the bonnet portion and advanceable through the septum into the vial when the bonnet portion is attached to the cap, the spike portion defining a fluid passage which fluidly communicates with the outflow aperture and is normally sealed by the septum when the bonnet portion is attached to the cap; wherein the creation of a vacuum within the loader device subsequent to the attachment of the bonnet portion to the cap of the vial and the engagement of the loader device to the connector portion causes the fluid medication within the vial to be drawn between the septum and the spike portion into the fluid passage and into the loader device via the outflow aperture.

32. The vial adaptor of Claim 31 wherein the spike portion includes three flow openings formed therein which each fluidly communicate with the fluid passage and are normally sealed by the septum when the bonnet portion is attached to the cap.

33. The vial adaptor of Claim 31 wherein the connector portion of the vial adaptor includes external threads formed thereon and the loader device is formed to include internal threads so as to be threadably engagable to the connector portion.

34. The vial adaptor of Claim 33 wherein the external threads of the connector portion and the internal threads of the loader device are Luer threads.

35. In combination: a vial adaptor for use in drawing a fluid medication from within a vial having a cap which includes a pierceable septum, the vial adaptor comprising: a bonnet portion releasably attachable to the cap of the vial; a connector portion extending from the bonnet portion and including an outflow aperture disposed therein; and an elongate spike portion extending within the bonnet portion and advanceable through the septum into the vial when the bonnet portion is attached to the cap, the spike portion defining a fluid passage which fluidly communicates with the outflow aperture and is normally sealed by the septum when the bonnet portion is attached to the cap; a loader device releasably engagable to the connector portion of the vial adaptor and placeable into fluid communication with the outflow aperture thereof; wherein the creation of a vacuum within the loader device subsequent to the attachment of the bonnet portion to the cap of the vial and the engagement of the loader device to connector portion causes the fluid medication within the vial to be drawn between the septum and the spike portion into the fluid passage and into the loader device via the outflow aperture.

36. The combination of Claim 35 wherein the loader device comprises: a hollow, tubular sheath having opposed ends; a coupler member disposed on one end of the sheath, the coupler member being releasably engagable to the connector portion of the vial adaptor, and sized and configured to place the sheath into fluid communication with the outflow aperture of the connector portion when engaged thereto; and a piston member movably connected to the sheath, the piston member being movable in a first direction away from the coupler member and a second direction toward the coupler member.

37. The combination of Claim 36 wherein the piston member is threadably connected to the sheath.

38. The combination of Claim 36 wherein the connector portion of the vial adaptor includes external threads formed thereon and the coupler member of the loader device is formed to include internal threads so as to be threadably engagable to the connector portion.

39. The combination of Claim 38 wherein the external threads of the connector portion and the internal threads of the coupler member are Luer threads.

40. A cartridge adaptor for facilitating the transfer of a fluid medication within a cartridge having a cap which includes a pierceable septum into a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber, the cartridge adaptor comprising: a bonnet portion advanceable over the cap of the cartridge; a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the needleless syringe and including an inflow opening disposed therein which is placeable into fluid communication with the discharge orifice; and an elongate spike portion extending within the bonnet portion and advanceable through the septum into the cartridge when the bonnet portion is advanced over the cap, the spike portion defining a fluid passage which fluidly communicates with the inflow opening; wherein the application of compressive pressure to the fluid medication within the cartridge subsequent to the advancement of the spike portion through the septum and the engagement of the connector portion to the needleless syringe causes the fluid medication within the cartridge to be forced into the delivery chamber via the fluid passage, the inflow opening, and the discharge orifice .

41. The cartridge adaptor of Claim 40 wherein the spike portion comprises a segment of hypodermic needle tubing.

42. The cartridge adaptor of Claim 40 wherein the connector portion defines a bore sized and configured to receive and releasably engage a portion of the needleless syringe, the inflow opening being in fluid communication with the bore.

43. The syringe of Claim 42 wherein the body includes external threads formed thereon and the connector portion includes internal threads formed therein such that the cartridge adaptor is threadably connectable to the body of the needleless syringe.

44. The syringe adaptor of Claim 43 wherein the external threads of the body and the internal threads of the connector portion are Luer threads.

45. The cartridge adaptor of Claim 40 wherein: the cartridge is disposed within an injector pen; and the bonnet portion of the cartridge adaptor is sized and configured to receive and releasably engage a portion of the injector pen; the spike portion being advanceable through the septum when the bonnet portion is engaged to the injector pen.

46. The cartridge adaptor of Claim 45 wherein the injector pen includes external threads formed thereon and the bonnet portion includes internal threads formed therein such that the cartridge adaptor is threadably connectable to the injector pen.

47. The cartridge adaptor of Claim 46 wherein the external threads of the injector pen and the internal threads of the bonnet portion are Luer threads.

48. The cartridge adaptor of Claim 45 wherein: the spike portion defines a distal piercing tip; and the bonnet portion has a generally cylindrical configuration, and is sized and configured to extend beyond the distal piercing tip of the spike portion and to be slidably advanceable over a portion of the injector pen.

49. A method of filling a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a cartridge of an injector pen, the method comprising the steps of:

(a) providing a cartridge adaptor comprising: a bonnet portion sized and configured to be releasably engagable to the injector pen; a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the needleless syringe and including an inflow opening disposed therein which is placeable into fluid communication with the discharge orifice; and a spike portion extending within the bonnet portion and advanceable into the cartridge when the bonnet portion is engaged to the injector pen, the spike portion defining a fluid passage which fluidly communicates with the inflow opening;

(b) attaching the bonnet portion of the cartridge adaptor to the injector pen; (c) attaching the needleless syringe to the connector portion of the cartridge adaptor; and

(d) transferring the fluid medication from within the cartridge of the injector pen into the delivery chamber of the body via the fluid passage, the inflow opening, and the discharge orifice.

50. The method of Claim 49 wherein the injector pen includes external threads formed thereon, the bonnet portion of the cartridge adaptor includes internal threads formed therein, and step (b) comprises threadably connecting the cartridge adaptor to the injector pen.

51. The method of Claim 49 wherein the body of the needleless syringe includes external threads formed thereon, the connector portion of the cartridge adaptor includes internal threads formed therein, and step (c) comprises threadably connecting the needleless syringe to the cartridge adaptor.

52. A syringe adaptor for filling a needleless syringe having a body which defines a delivery chamber and includes a discharge orifice in fluid communication with the delivery chamber with a prescribed dosage of a fluid medication within a syringe filled therewith, the syringe adaptor comprising: a bonnet portion releasably attachable to the body of the needleless syringe; and a connector portion extending from the bonnet portion, the connector portion being sized and configured to be releasably engagable to the syringe and to place the syringe into fluid communication with the discharge orifice when the bonnet portion is attached to the body and the connector portion is attached to the syringe.