WO2009126720A1

WO2009126720A1 - Fluid control device having a safety needle

Info

Publication number: WO2009126720A1
Application number: PCT/US2009/039924
Authority: WO
Inventors: Terrence Edward Weston; Freddy Zinger
Original assignee: West Pharmaceutical Services, Inc.
Priority date: 2008-04-08
Filing date: 2009-04-08
Publication date: 2009-10-15

Abstract

A fluid control device is provided that includes a flow control member displaceable between first and second flow control positions enabling flow paths between pairs of ports, such as a first port, a second port, and a third port. The second port is configured to receive a syringe. The third port includes an adaptor having a fluid conduit member for extending into an interior of a medicinal vessel attached to the adaptor. The fluid control device further includes a safety needle connected to the first port.

Description

TITLE OF THE INVENTION [0001] Fluid Control Device Having A Safety Needle

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority pursuant to 35 U.S. C. § 119(e) of U.S. Provisional Patent Application No. 61/043,238, filed April 8, 2008, the disclosures of which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0003] The present invention relates to the incorporation of a passive needle protection system for needles used with a fluid control device for facilitating the safe parenteral administration of medicine, and more specifically to a fluid control device having a passive needle protection system where the passive needle protection system is automatically armed or activated through use of the fluid control device.

[0004] Drugs intended for parenteral administration are typically stored in a medicinal vessel either as a dry powder or as a solution. The solution can be ready for immediate use or in the form of a liquid concentrate which requires reconstitution with a physiological solution prior to administration in a similar manner to a dry powder drug. The physiological solution can be provided in a pre-filled syringe or a medicinal vessel.

[0005] Medicinal vessels typically fall into one of three categories. The first type is a vial or a glass bottle closed by a rubber stopper which can be penetrated by a puncturing tool, for example, a needle, and which is self-closing upon withdrawal of the puncturing tool. Such a vial or glass bottle can contain a single dose or multiple doses of a drug. The drug contained in a vial can be under a high vacuum. The second type is an ampoule whose top portion is broken off enabling access to its contents. The third type is an I.V. bag provided with a sample port for enabling access to its contents. The sample port can be of the pre-slit septum type.

[0006] Regardless of the manner in which a drug is stored, there is a need to transfer fluid under sterile conditions before its administration to a patient by a dispensing tool be it a needle, a pre-slit septum, or the like. When a prior dilution of a drug is required, the process requires at least two fluid transfers. The problem of ensuring proper fluid transfer under aseptic conditions is especially acute in the case of administration of drugs by patients in their homes.

[0007] Though a removable cap is usually included, accidental needle sticks can occur when the needle is not in use or when replacing a cap on the needle. Additionally, the dispensing tools discussed above permit the re-use of needles. [0008] Various safety shield systems have been developed and proposed for conventional hypodermic syringes. Such safety shield systems may include a tubular shield that is spring biased to enclose the needle cannula and to lock in the extended enclosed position following injection. Such safety shield systems for conventional hypodermic syringes are operated manually, requiring an additional action, such as a twist or other force, to activate the safety shield. [0009] It would therefore be desirable to provide a fluid control device with a passive needle shield. More specifically, it would be desirable to provide a fluid control device with a needle shield that is activated or armed automatically during the preparation of the solution.

BRIEF SUMMARY OF THE INVENTION

[0010] In a preferred embodiment, the present invention provides for a fluid control device comprising: a first port; a second port to receive a syringe; a third port that includes an adaptor having a fluid conduit member extending into an interior of a medicinal vessel attached to the adaptor; a flow control member displaceable between first and second flow control positions enabling flow paths between pairs of ports of the first, second, and third ports; and a safety needle connected to the first port that includes: a needle, a hub at least partially surrounding and mounted to the needle and connected to the first port such that the needle is in fluid communication with the first port, a slidable sleeve mounted on the hub and in direct sliding engagement with the hub in an axial direction, the slidable sleeve having a radially elastically deformable portion, and the hub having a radially converging or diverging portion, wherein the slidable sleeve is slidable in a first axial direction between a first position to fully or substantially fully surround the needle and a second position to expose the needle, wherein sliding between the first and second positions causes deformation of the radially elastically deformable portion, and wherein the slidable sleeve is slidable in a second axial direction between the second position and a third position to fully surround the needle, the force to slide the slidable sleeve in the second axial direction being provided by the radially elastically deformable portion.

[0011] In another preferred embodiment, the present invention provides for a fluid control device comprising: a first port; a second port to receive a syringe; a third port that includes an adaptor having a fluid conduit member extending into a medicinal vessel attached to the adaptor; a flow control member connected to the adaptor and displaceable between first and second flow control positions respectively enabling flow paths between pairs of the first, second and third ports; a safety needle that includes: a needle in communication with the first port, a needle hub at least partially surrounding the needle, and a sleeve slidable configured to slide relative to the needle hub between an initial position, an intermediate position, a retracted position, and an extended position; a pack that includes a camming member, wherein the pack initially covers the needle, needle hub, and slidable sleeve; and an activation device for activating the safety needle that includes: a base mounted to the fluid control device, and a camming surface on the base, wherein the camming surface operatively engages the camming member to move the pack proximally and to move the slidable sleeve into the intermediate position.

[0012] In yet another preferred embodiment, the present invention provides for a fluid control device comprising: a first port; a second port to receive a syringe; a third port that includes an adaptor having a fluid conduit member extending into an interior of a medicinal vessel attached to the adaptor; a flow control member displaceable between first and second flow control positions enabling flow paths between pairs of ports of the first, second, and third ports; and a safety needle connected to the first port that includes: a needle, a hub at least partially surrounding the needle and connected to the first port such that the needle is in fluid communication with the first port, a slidable sleeve mounted on the hub and in direct sliding engagement with the hub in an axial direction, the slidable sleeve having a radially elastically deformable portion, and the hub having a radially converging or diverging portion, wherein the slidable sleeve is slidable in a first axial direction between a first position wherein the needle is at least partially exposed and a second position wherein the needle is further exposed, sliding between the first and second positions causing deformation of the radially elastically deformable portions, and wherein the slidable sleeve is slidable in a second axial direction between the second position and a third position to fully surround the needle, the force to slide the slidable sleeve in the second axial direction being provided by the bias of the radially elastically deformable portions.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0013] The following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. [0014] In the drawings :

[0015] Fig. 1 is a perspective view of an assembled fluid control device including a base member, an integrally formed adaptor cum flow control member and a safety needle for use with a syringe and a medicinal vessel; [0016] Fig. 2 is a perspective view of the fluid control device and safety needle of Fig. 1 before assembly;

[0017] Fig. 3 is a cross-sectional elevational view of the fluid control device and safety needle of

Fig. 1 taken along line B-B, after insertion of a syringe and the attachment of a vial and before rotation of the adaptor relative to the base member;

[0018] Fig. 4 is a cross-sectional plan view of the fluid control device and safety needle of Fig. 1 taken along line A-A after insertion of a syringe and the attachment of a vial and before rotation of the adaptor relative to the base member;

[0019] Fig. 5 is a cross-sectional plan view of the fluid control device and safety needle of Fig. 1 taken along line C-C before rotation of the adaptor relative to the base member;

[0020] Fig. 6 is a cross-sectional elevational view of the fluid control device and safety needle of

Fig. 1 taken along line B-B after rotation of the adaptor relative to the base member;

[0021] Fig. 7 is a cross-sectional plan view of the fluid control device and safety needle of Fig. 1 taken along line A-A after rotation of the adaptor relative to the base member;

[0022] Fig. 8 is a cross-sectional plan view of the fluid control device and safety needle of Fig. 1 taken along line C-C after rotation of the adaptor relative to the base member;

[0023] Fig. 9 is an exploded perspective view of a modified integrally formed adaptor cum flow control member adapted such that the adaptor breaks off from the flow control member on rotation of the adaptor relative to the base member beyond a pre-determined position;

[0024] Fig. 10 is an exploded perspective view of a fluid control device and safety needle including the modified adaptor cum flow control member of Fig. 9 after the adaptor has been broken off;

[0025] Fig. 11 is a perspective view of an assembled fluid control device and safety needle including a base member and an adaptor designed for releasable engagement with the base member;

[0026] Fig. 12 is an exploded perspective view of the fluid control device and safety needle of

Fig. 11 after the adaptor has been rotated through a quarter turn ready for its detachment from the base member;

[0027] Fig. 13 is a cross-sectional elevational view of the base member of the fluid control and safety needle device of Fig. 11 ;

[0028] Fig. 14 is a cross-sectional elevational view of the adaptor of the fluid control and safety needle device of Fig. 11;

[0029] Fig. 15 is a perspective view of the flow control member of the fluid control and safety needle device of Fig. 11; [0030] Figs. 16A and 16B are cross-sectional elevational views of a fluid control device in which the flow control member is required to be rotated through 180 degrees to enable switching between its flow control positions;

[0031] Fig. 17 is a cross-sectional elevational view of a fluid control device and safety needle provided with an arrangement for the venting of a vial attached to its adaptor;

[0032] Figs. 18 A and 18B are elevational views of a fluid control device having a filter for filtering air venting a vial attached to its adaptor, the filter being provided as a discrete element exterior to the device;

[0033] Fig. 19 is a cross-sectional elevational view of a fluid control device and safety needle having an adaptor provided with a cavity for receiving a filter for filtering air venting a vial attached thereto;

[0034] Fig. 20 is a cross-sectional elevational view of a fluid control device and safety needle in a first operative position enabling flow communication between a medicinal vessel containing a powder drug and a medicinal vessel containing a physiological solution for enabling reconstitution of the powder drug;

[0035] Fig. 21 is a cross-sectional elevational view of the fluid control device and safety needle of Fig. 20 in a second operative position enabling flow communication between the vial containing the reconstituted drug and a syringe;

[0036] Fig. 22 is a cross-sectional elevational view of the fluid control and safety needle device of Fig. 20 in a third operative position enabling flow communication between the syringe and a dispensing port;

[0037] Fig. 23 is a rear side perspective view of the safety needle shown in Fig. 1 ;

[0038] Fig. 24 is a front elevational view of the safety needle shown in Fig. 1;

[0039] Fig. 25 is a side elevational view of the safety needle shown in Fig. 1 and a perspective view of a packing sleeve;

[0040] Fig. 26 is a partial side cross-sectional elevational view of the safety needle and packing sleeve shown in Fig. 25;

[0041] Fig. 27A is a side elevational view of the safety needle shown in Fig. 1 in the storage position;

[0042] Fig. 27B is a cross-sectional elevational view of the safety needle taken along line B-B in

Fig. 27A;

[0043] Fig. 27C is a side elevational view of the safety needle shown in Fig. 27 A in the ready or loading position; [0044] Fig. 27D is a cross-sectional elevational view of the safety needle taken along line D-D in Fig. 27C;

[0045] Fig. 27E is a side elevational view of the safety needle shown in Fig. 27 A in the fully retracted position;

[0046] Fig. 27F is a cross-sectional elevational view of the safety needle taken along line F-F in

Fig. 27E;

[0047] Fig. 27G is a side elevational view of the safety needle shield shown in Fig. 27A in the fully extended position;

[0048] Fig. 27H is a cross-sectional elevational view of the safety needle taken along line H-H in Fig. 27G;

[0049] Fig. 28 is a partial perspective view of an assembled fluid control and safety needle device of Fig. 1 including a cammed base member, an adaptor and a safety needle;

[0050] Fig. 29 is a side elevational view of an alternative safety needle for attachment to the fluid control device;

[0051] Fig. 30 is a center-line cross-sectional elevational view of the safety needle shown in Fig.

29;

[0052] Fig. 31 is a center-line cross-sectional elevational view of the slidable sleeve of the safety needle shown in Fig. 30 with the slidable sleeve partly retracted to expose the hollow needle;

[0053] Fig. 32 is a center-line cross-sectional elevational view of the safety needle shown in Fig.

30 with the slidable sleeve in an extended and locked position;

[0054] Fig. 33 is a partial side elevational view of a detent mechanism of the safety needle shown in Fig. 29;

[0055] Fig. 34 is a bottom plan view of the receiving end of the slidable sleeve of the safety needle shown in Fig. 29 showing the cantilever arms;

[0056] Fig. 35 is a center-line cross-sectional elevational view of the safety needle shown in Fig.

30;

[0057] Fig. 36 is a cross-sectional elevational view of another alternative integral syringe barrel and needle hub safety needle for attachment to the fluid control device of the present invention;

[0058] Fig. 37 is a side elevational view of yet another alternative safety needle as assembled by the manufacturer but prior to inserting it into a pack, for attachment to the fluid control device of the present invention;

[0059] Fig. 37A is a partial enlarged side elevational view of the safety needle shown in Fig. 37; [0060] Fig. 38 is a center-line cross-sectional elevational view of the safety needle shown in Fig.

37 in a pack;

[0061] Fig. 38A is a top plan view of the safety needle shown in Fig. 38;

[0062] Fig. 39 is a partial cross-sectional elevational view of the safety needle shown in Fig. 37 showing how the pack is used to hold the safety needle;

[0063] Fig. 40 is a partial cross-sectional elevational view of the safety needle shown in Fig. 37 in an initial position with the pack removed;

[0064] Fig. 41 is a partial cross-sectional elevational view of the safety needle shown in Fig. 40 with an alternative shroud to increase the protection against needle stick injuries, while allowing the needle bevel to be seen immediately prior to giving the injection;

[0065] Fig. 42 is a partial cross- sectional elevational view of the safety needle shown in Fig. 37 during injection into a patient;

[0066] Fig. 42A is a top plan view of the safety needle shown in Fig. 42;

[0067] Fig. 43 is a partial cross-sectional elevational view of the safety needle shown in Fig. 37 in an extended position following injection with the protective slidable sleeve locked in the extended position to cover the tip of the needle;

[0068] Fig. 43 A is a center-line cross-sectional elevational view of the safety needle shown in

Fig. 37 showing part of the locking mechanism;

[0069] Fig. 44 is a cross-sectional elevational view of another alternative safety needle and packing sleeve for attachment to the fluid control device of the present invention;

[0070] Fig. 45 is a perspective view of the hub of the safety needle shown in Fig. 44;

[0071] Fig. 46 is a perspective view of yet another alternative safety needle and packing sleeve with a releasable membrane partially removed for attachment to the fluid control device of the present invention;

[0072] Fig. 47 is a cross-sectional elevational view of the packing sleeve shown in Fig. 46 with the safety needle removed;

[0073] Fig. 48 is a center-line cross-section elevational view of the safety needle and packing sleeve shown in Fig. 46 with the safety needle in an initial position;

[0074] Fig. 49 is a center-line cross-section elevational view of the safety needle and packing sleeve shown in Fig. 46 with the safety needle in an intermediate position;

[0075] Fig. 50 is a perspective view of another alternative safety needle in an initial position for attachment to the fluid control device of the present invention; [0076] Fig. 51 is an exploded perspective view of the safety needle shown in Fig. 50 with the nose cone shown in cross-section;

[0077] Fig. 52 is a rear plan view of the proximal end of the safety needle shown in Fig. 50 with the slidable sleeve in a retracted position;

[0078] Fig. 53 is a perspective view of the safety needle shown in Fig. 50 in an extended position;

[0079] Fig. 54 A is a side elevational view of the safety needle shown in Fig. 50 in the initial position with the packing sleeve shown in Fig. 46 in cross-section;

[0080] Fig. 54B is a cross-sectional elevational view of the safety needle and packing sleeve shown in Fig. 54A taken along line B-B;

[0081] Fig. 54C is a partial cross-sectional elevational view of the safety needle and packing sleeve shown in Fig. 54A in an intermediate position;

[0082] Fig. 54D is a cross-sectional elevational view of the safety needle and packing sleeve shown in Fig. 54C taken along line D-D;

[0083] Fig. 54E is a side elevational view of the safety needle shown in Fig. 54A after removing the packing sleeve and in the intermediate position just prior to injection;

[0084] Fig. 54F is a side elevational view of the safety needle shown in Fig. 54A injected into a patient and in the retracted position;

[0085] Fig. 54G is a cross-sectional elevational view of the safety needle shown in Fig. 54F taken along line G-G;

[0086] Fig. 54H is a side elevational view of the safety needle shown in Fig. 54A following removal from a patient in the extended position;

[0087] Fig. 541 is a cross-sectional elevational view of the safety needle shown in Fig. 54H taken along line I-I;

[0088] Fig. 55 J is a cross-sectional elevational view of the safety needle shown in Fig. 541 with the slidable sleeve in a tilted and locked position;

[0089] Fig. 55 is an elevational view of yet another alternative safety needle for attachment to the fluid control device of the present invention;

[0090] Fig. 56 is a cross-sectional elevational view of the safety needle of Fig. 55 assembled within a packing sleeve; and

[0091] Fig. 57 is an elevational view of a needle hub of the safety needle of Fig. 55. DETAILED DESCRIPTION OF THE INVENTION

[0092] Certain terminology is used in the following description for convenience only and is not limiting. The words "right," "left," "lower" and "upper" designate directions in the drawings to which reference is made. The words "inwardly" and "outwardly" refer to directions toward and away from, respectively, the geometric center of a fluid control device and needle shield or safety needle in accordance with the present invention, and designated parts thereof. The terminology includes the words noted above, derivatives thereof and words of similar import. [0093] Figs. 1-8 depict a first preferred embodiment of a fluid control device, generally designated 10, that is generally described in U.S. Patent No. 6,238,372, which is hereby incorporated by reference in its entirety. The fluid control device 10 is constructed and operative in accordance with the teachings of the present invention for enabling fluid flow control between a syringe 32, a medicinal vessel 28 and a needle 122 (Fig. 3). The fluid control device 10 includes an elongated base member 11 having a port 12 adapted for receiving the syringe 32 and a dispensing port 13 for attachment to a safety needle 150. The dispensing port 13 is preferably threadingly attached to the safety needle 150 as shown. The safety needle 150 may also be attached to the fluid control device 10 by a snap fit, Luer adapter fit or some other form of connection or may be integrally formed or molded to the fluid control device 10. The port 12 is typically fashioned as a female Luer connector for engaging with a corresponding male Luer connector (not shown) of the syringe 32 but the syringe 32 could be connected to the port 12 in some other manner. [0094] As shown in Figs. 3, 4, 6 and 7, the port 12 includes a lumen 14 having an interior opening 14' and the dispensing port 13 includes a lumen 16 having an interior opening 16'. The lumens 14 and 16 are co-axial and in fluid communication via a bore 17 transversely disposed relative to the elongated base member 11. The bore 17 includes an upper peripheral flange 18 and a lower minor peripheral abutment wall portion 19' protruding radially inwardly relative to its major peripheral wall portion 19" (see Fig. 5). As shown, the abutment wall portion 19' typically extends through an arc angle of about 90 degrees.

[0095] Referring to Figs. 2-4, the fluid control device 10 further includes an integrally formed adaptor cum flow control member, generally designated 20, for insertion into the bore 17 in which it is restrained by a peripherally formed groove 22 designed for receiving the flange 18 therein. The flow control member 20 is formed with two flow ducts. The first flow duct 23 (see Fig. 3) is in the form of an L-shaped channel having a radial aperture 23' for registration with the interior opening 14' and an axial aperture 23" of a fluid conduit member 24 integrally formed as part of the adaptor 20" on disposition of the flow control member 20' in a first flow control position enabling fluid communication between a syringe inserted in the port 12 and a vessel attached to the adaptor 20". The second flow duct 25 (see Fig. 4) in the form of a peripheral slightly longer than a semi-circular groove 25 having a first end portion 25' for registration with one of the interior openings 14' and 16' and a second end portion 25" for registration with the other of the interior openings 14' and 16' on disposition of the flow control member 20' in a second flow control position enabling fluid communication between a syringe 32 inserted in the port 12 and the needle 122. [0096] In addition, the flow control member 20' is provided with a minor peripheral abutment wall portion 26' protruding radially outwardly relative to its major peripheral wall portion 26" (see Fig. 5). As shown, the abutment wall portion 26' typically extends through an arc angle of about 90 degrees. The minor peripheral abutment wall portions 19' and 26' are so disposed such that they assume substantially diagonally opposing positions relative to one another (see Fig. 5) in the first flow control position of the flow control member 20'.

[0097] The adaptor 20" is shown to be adapted for the attachment thereto of a vial 28 (not drawn to size) provided with a rubber stopper 29. As such, one side of the fluid conduit member 24 is fashioned with a sharp point which serves as a puncturing tool 30 for penetrating the rubber stopper 29 on attachment of a vial 28 to the adaptor 20". Alternatively, the adaptor 20" can be adapted for the attachment of an ampoule 31 (not drawn to size, see Fig. 1), the difference being that such an adaptor will preferably have relatively long springy grips.

[0098] Each stage of the two stage operation of the fluid control device 10 for the administration of a drug provided in powder form for dilution with a physiological solution provided in a pre-filled syringe is now described with reference to Figs. 3-5 and Figs. 6-8, respectively. [0099] As shown in Figs. 3-5, the fluid control device 10 is best provided in a set-up position in which the flow control member 20' is in its first flow control position and the two minor abutment wall portions 19' and 26' are diagonally opposed to one another. It should be noted, as best seen in Fig. 4, that the semi-circular groove 25 registers with the interior opening 16' but does not provide a flow path.

[00100] In this arrangement, a pre-filled syringe 32 is inserted into the port 12 and the vial 28 is attached to the adaptor 20" so that the puncturing tool 30 punctures the vial's rubber stopper 29, thereby enabling fluid communication with its interior via the fluid conduit member 24. Typically, the syringe 32 requires actuation for expressing its contents into the vial 28 while, in some cases, if the contents of the vial 28 are under vacuum, then the physiological solution of the syringe 32 can be sucked into the vial 28 without user intervention. Thereafter, the contents of the vial 28 are shaken so as to reconstitute the powdered drug. The fluid control device 10 together with the vial 28 are then preferably inverted and the syringe 32 is aspirated so as to draw the reconstituted liquid drug thereinto.

[00101] Turning now to Figs. 6-8, the vial 28 together with the adaptor 20" are rotated in either a clockwise or a counter clockwise direction relative to the base member 11 until the abutment wall portion 26' is stopped by the abutment wall portion 19' (see Fig. 8). On rotation of the adaptor 20", the flow control member 20' is rotated to its second flow control position enabling a flow path between the syringe 32 and the dispensing port 13 through the end portions 25' and 25" of the semicircular groove 25 registering with the interior openings 14' and 16'. The medicament can then be dispensed by actuation of the syringe 32.

[00102] It can now be readily appreciated that the fluid control device 10 ensures that a drug can be administered to a patient under aseptic conditions. Furthermore, it can be readily appreciated that the fluid control device 10 presents a "fool-proof delivery device in the sense that a patient is required to perform a minimal number of actions to administer a drug and that the drug can only be dispensed in a single operative position of the fluid control device 10.

[00103] Figs. 9 and 10 depict a second preferred embodiment of a fluid control device, generally designated 34, constructed and operative in accordance with the teachings of the present invention for enabling fluid flow control between a syringe, a medicinal vessel and a dispensing port. The fluid control device 34 is similar in construction and operation to the fluid control device 10 and therefore the same reference numbers are used where appropriate.

[00104] The main difference between the two fluid control devices 34 and 10 resides in the fact that the former includes an integrally formed adaptor cum flow control member 35 provided with a weakened portion, generally designated 36, between the abutment wall portion 26' of its flow control member 35' and the adaptor 35". As shown, this weakened portion 36 is achieved by leaving radially extending vanes 36' formed by cut-outs 36".

[00105] The advantage of this design is that after rotation of the vial 28 (not shown) and the adaptor 35" through 90 degrees so as to rotate the flow control member 35' from the first flow control position to the second flow control position, any further rotational torque applied will snap off the adaptor 35" which can then be discarded together with the vial, thereby rendering a less cumbersome and lighter remaining assembly (see Fig. 10) to facilitate the administration of a drug. [00106] A further difference between the fluid control devices 34 and 10 resides in the fact the former includes a dispensing port 38 fashioned as a male Luer connector. [00107] Figs. 11-15 depict a third preferred embodiment of a fluid control device, generally designated 40, constructed and operative in accordance with the teachings of the present invention for enabling fluid flow control between a syringe, a medicinal vessel and a dispensing port. The fluid control device 40 is similar in construction and operation to the fluid control device 10 and therefore the same reference numerals are used where appropriate.

[00108] The main difference between the two fluid control devices 40 and 10 resides in the fact that the former includes an adaptor 41 designed for a non-destructive detachable engagement with a flow control member 42. As such, the base member 11 is provided with a downwardly depending rectangular shaped skirt 43 having outwardly extending flanges 43' and 43" for engagement by an upwardly extending rectangular shaped grip 44 of the adaptor 41 which includes inwardly directed grooves 44' and 44" for receiving and retaining the flanges 43' and 43". In addition, the adaptor 41 is provided with an upwardly extending stem 46 having a rectangular shaped key 46' for insertion into a similarly sized and shaped slot 42' formed in the underside of the flow control member 42 (Fig. 15).

[00109] In the fluid control device 40, the flow control member 42 is disposed in its first flow control position enabling a flow path between the port 12 and a vial 28 to be attached to the adaptor 41 when the adaptor 41 is mounted on the base member 11. Conversely, on the rotation of the adaptor 41 relative to the base member 11 to a position enabling axial detachment therefrom (see Fig. 12), the adaptor 41 urges the flow control member 42 from its first flow control position to its second flow control position enabling a flow path between the port 12 and the dispensing port 13. Preferably, there is a screw thread engagement between the base member 11 and the adaptor 41 designed such that there is an axial displacement of the adaptor 41 away from the base member 11 when it is rotated from its engaging position to its disengaging position.

[00110] It can be readily appreciated that the advantage of this design over the design of the fluid control device 34, while retaining all the advantages of the latter, resides in the fact that the former is reusable after sterilization while the latter can only be used once due to the destruction of the adaptor cum flow control member 42.

[00111] Figs. 16A and 16B depict a fourth preferred embodiment of a fluid control device, generally designated 48, constructed and operative in accordance with the teachings of the present invention for enabling fluid flow control between a syringe (not shown), a medicinal vessel (not shown) and a dispensing port. The fluid control device 48 is similar in construction and operation to the fluid control device 10 and therefore the same reference numerals are used where appropriate. [00112] The main difference between the two fluid control devices 48 and 10 resides in the fact that the former includes a flow control member 49 which is required to be rotated through a 180 degree turn between its first flow control position (see Fig. 16A) and its second flow control position (see Fig. 16B). In particular, the flow control member 49 includes an inclined channel 50 having a radial aperture 50' for registration with the interior opening 14' and an axial aperture 50" for registration with the fluid conduit member 24 so as to enable the flow path between a syringe and the interior of the medicinal vessel. The flow control member 49 also includes a second inclined channel 52 having a radial aperture 52' for registration with the interior opening 14' and a radial aperture 52" for registration with the interior opening 16' to enable the flow path between a syringe to the dispensing port 13. As shown, in this case, the lumens 14 and 16 are aligned but not co-axial. [00113] Figs. 17-19 depict other modified fluid control devices, generally designated 53, 54 and 55, constructed and operative in accordance with the teachings of the present invention for enabling fluid flow control between a syringe, a medicinal vessel or vial 28 and the needle 122. The fluid control device 53, 54 and 55 are similar in construction and operation to the fluid control device 10 and therefore the same reference numerals are used where appropriate. The main difference between the fluid control devices 53, 54 and 55 and the fluid control device 10 is that they provide arrangements for venting vial 28 and, if necessary, for filtering incoming air. [00114] Turning now to Fig. 17, the fluid control device 53 includes an adaptor 56 provided with a venting conduit 58 for venting a vial 28 to the atmosphere in addition to the fluid conduit member 24. The venting conduit 58 is preferably provided with a filter 59 for filtering incoming air. Filters 59 applicable to the present invention are well known in the art and a detailed description of them is not necessary for a complete understanding of the invention. Such filters 59, for example can include porous materials that include porous plastic, porous paper, porous ceramic materials, and the like. Turning now to Figs. 18a and 18b, the fluid control device 54 is similar to the fluid control device 53 except that it includes a filter 60 exterior to the adaptor 56. Turning now to Fig. 19, the fluid control device 55 is similar to the fluid control device 53 except that its adaptor 61 includes an integrally formed distally disposed filter 62. Radially spaced vents 63 communicate with the vial 28 through the filter 62 to filter the air traveling into the vial 28.

[00115] Figs. 20-22 depict a fluid control device, generally designated 64, for enabling the reconstitution of a powder drug with a physiological solution contained in a medicinal vessel instead of within a pre-filled syringe as required with the fluid control device 10. The fluid control device 64 is similar in construction and operation to the fluid control device 10 and therefore the same reference numerals are used where appropriate.

[00116] The main difference between the two fluid control devices 64 and 10 resides in the fact that the former is adapted to be fitted with two medicinal vessels and, as such, its base member 11 is provided with a port 12, a dispensing port 13 and two bores 17A and 17B which are interconnected by a channel 65. As shown, the medicinal vessels are vials 28 A and 28B where the vial 28A contains the powdered drug and the vial 28B contains the physiological solution for diluting the powdered drug. As explained in greater detail below for the case when the vial 28 A has its contents under a high vacuum, the sequence and order of the attachment of the vials 28 A and 28B to the adapters 41 A and 41B is not arbitrary.

[00117] In this case, the flow control member 42 A has a first flow control position in which its L- shaped flow duct 23 A registers in flow communication with the channel 65 and a medicinal vessel attached to its adaptor 41 A (see Figs. 20 and 21) and a second flow control position in which its peripheral groove flow duct 25A registers in fluid communication with the channel 65 and the dispensing port 13 (see Fig. 22). In contrast, the flow control member 42B has a first flow control position in which its L- shaped flow duct 23 B registers in fluid communication with the channel 65 and a medicinal vessel 28B attached to its adaptor 41 B (see Fig. 20) and a second flow control position in which its peripheral groove flow duct 25B registers in fluid communication with the channel 65 and the port 12 (see Figs. 21 and 22).

[00118] The operation of the fluid control device 64 for the administration of a powder drug provided in the vial 28A after reconstitution with a physiological solution provided in the vial 28B is now described. First, as shown in Fig. 20, the fluid control device 64 is provided in its first operative position, namely, enabling the flow path between the vials 28A and 28B when they are attached to the base member 11. It should be noted that the vial 28B is attached to the adaptor 41 B and thereafter the vial 28 A is attached to the adaptor 41 A such that the physiological solution contents of the vial 28B is sucked into the vial 28 A. Reconstitution typically requires shaking the fluid control device 64. As shown in Fig. 21, the adaptor 41B together with the vial 28B are then rotated so as to enable their detachment from the base member 11 while, at the same time, effecting the rotation of the flow control member 42B to the second position to enable a flow path between the port 12 and the remaining vial 28 A. A syringe 66 is inserted into the port 12 and, after inversion of the fluid control device 64 such that the vial 28 containing the reconstituted drug assumes an upward position, the syringe 66 is aspirated to draw the contents of the vial 28A thereinto. Thereafter, as shown in Fig. 22, the adaptor 41 A together with the vial 28 A are rotated so as to enable their detachment from the base member 11 while, at the same time, effecting the rotation of the flow control member 42A to the second position to enable a flow path between the syringe 66 and the dispensing port 13. Finally, in this position, the syringe 66 is actuated so as to express the drug for its administration to a patient via the safety needle 122. [00119] Referring to Figs.23-27H, the safety needle, generally designated 150, is described and shown. A related safety needle, for use with conventional syringes, is generally described in published European Patent Application Number 1 535 640 Al, which is hereby incorporated by reference in its entirety.

[00120] The safety needle 150 of the present invention includes a needle hub 152 having a conical shape. The proximal end 154 of the needle hub 152 includes a mount 120 corresponding with the mount (not shown) of the dispensing port 13. The mount 120 of the needle hub 152 is preferably configured to mount to or otherwise engage with the dispensing port 13 of the fluid control device 10 to allow the safety needle 150 to be used with and easily adapted to the fluid control device 10. The fluid control device 10 may be reused while the safety needle 150 is disposed of or recycled after each use. Alternatively, the proximal end 154 of the safety needle 150 may be integrally formed with the dispending port 13.

[00121] When the safety needle 150 is mounted onto the fluid control device 10, the needle 122 is received within the dispensing port 13 and in fluid communication with the fluid control device 10. A preferred embodiment of the safety needle 150 includes a slidable sleeve 156 that is engaged with the needle hub 152 by cantilever arms 158. The safety needle 150 includes a circular retaining ring 160, disposed around the cantilever arms 158 of the slidable sleeve 156. The retaining ring 160 is rotatably engaged with the distal end of the needle hub 152 and functions to retain the slidable sleeve 156 on the needle hub 152. Specifically, referring to Fig. 24, the retaining ring 160 includes four evenly spaced apart holes 162 for accommodating each of the four cantilever arms 158 of the slidable sleeve 156 with sufficient clearance to allow sliding and flexing of the cantilever arms 158 when captured within the retaining ring 160. The flexing of the cantilever arms 158 creates a leaf spring arrangement of the sliding sleeve 156.

[00122] Referring to Fig. 28, the safety needle 150 can alternatively be assembled to the fluid control device 201 having an activating fluid control device 200 that primes or activates the safety needle 150 prior to injection. Referring to Figs. 25-28 a packing sleeve 164 is preferably removably mounted on the needle hub 152 over the slidable sleeve 156. The activating fluid control device 200 initially contains the safety needle 150 in an initial position (Figs. 27A-27B) covered with the packing sleeve 164. A proximal end 164a of the packing sleeve 164 includes a camming member, such as a radially extending pin 165. In the initial position, there is little, or no load on the cantilever arms 158, but the slidable sleeve 156 is keyed (not shown) such that the slidable sleeve 156 does not detach from the distal end of needle hub 152. The packing sleeve 164 initially houses the safety needle 150 in the initial position. When the safety needle 150 is installed on the activating fluid control device 200, the pin 165 of the packing sleeve 164 engages a camming surface 180 on the base member 220 of the fluid delivery device 200 (Fig. 28). The camming surface 180 is preferably configured as a groove 180 on the base member 220. The packing sleeve 164 and base member 220 must be rotated relative to each other in order to remove the packing sleeve 164 from the base member 220. That is, rotating or twisting the safety needle 150 relative to the adaptor 235 urges camming engagement of the pin 165 along the groove 180. The groove 180 includes a first end 180a that is radially spaced a first distance from a central longitudinal axis of the adapter 235 and a second end 180b that is radially spaced a second distance from the centrally longitudinal axis of the adaptor 235. The second distance is smaller than the first distance such that the arch formed by the groove 180 draws the packing sleeve 164 radially inwardly. That is, the groove 180 is radially space further from a center of the activating fluid control device 200 and curves inwardly toward an opening 182, e.g., groove exit 182, such that the pin 165 is urged toward the center of the activating fluid control device 200. As a result, the packing sleeve 164 is pulled toward the center of the activating fluid control device 200 as the safety needle 150 is twisted toward the groove exit 182. [00123] Because the distal end of the slidable sleeve 156 abuts the distal interior end of the packing sleeve 164 (Fig. 26), twisting the safety needle 150 with respect to the base member 220 forces the needle hub 152 into the cantilever arms 158 and the cantilever arms 158 slide up the needle hub 152 until at least one of the cantilever arms 158 snaps over a catch 166 and arms or sets the safety needle 150 in to an intermediate or injection position (see Figs. 27C and 27D). In the intermediate position, the needle 122 is at least partially exposed and ready for injection. In the intermediate position, the catch 166 prevents retraction of the slidable sleeve 156 along the same path in which the slidable sleeve 156 entered the catch 166. The needle hub 152 is prevented form further displacement with regard to the cantilever arms 158 by a shoulder 168 in the packing sleeve 164. The safety needle 150 is then removed from the base member 220 in the intermediate position in a similar manner to that of the fluid control device 64 and the packing sleeve 164 is then removed from the safety needle 150. Though it is preferred that removal of the safety needle 150 from the base member 220 activates or sets the safety needle 150 into the intermediate position, the safety needle 150 can alternatively be activated by removal of the packing sleeve 164. [00124] The needle 122 may be partially exposed or completely concealed when the safety needle 150 is in the storage position as shown in Figs. 27A and 27B. The packing sleeve 164 covers the needle 122 until the safety needle 150 is administered. Once the safety needle 150 has been removed from the base member 220 and the packing sleeve 164 has been removed from the safety needle 150, a shot may be administered to a patient. When the shot is administered, the safety needle 150 is initially either in the storage position shown in Figs. 23, 27 A and 27B or the loading or intermediate position shown in Figs. 27C and 27D. The needle 122 is inserted into the skin of the user (not shown) until the slidable sleeve 156 comes into contact with the skin. Further movement of the needle 122 into the skin urges the slidable sleeve 156 up the needle hub 152 as shown in Figs. 27E and 27F and thus the cantilever arms 158 are forced further outwardly by the conical surface of the needle hub 152. The slidable sleeve 156 is urged into the catch 166 and then forced against a cam surface 170 which causes the slidable sleeve 156 and cantilever arms 158 to rotate with respect to the needle hub 152. As the slidable sleeve 156 is urged further up the needle hub 152, more of the needle 122 is exposed and inserted deeper into the skin. When the needle 122 is withdrawn from the skin, the resulting spring leaf force of the cantilever arms 158 causes the slidable sleeve 156 to rapidly extend into a protective position shown in Figs. 27G and 27H covering the tip of the needle 122 and thereby inhibiting accidental needle sticks with the needle 122 thereafter. The slidable sleeve 156 bypasses the catch 166 because the cantilever arms 158 are now radially offset from the catch 166 and are unimpeded as they slide down the needle hub 152. In the protective position, the cantilever arms 158 are locked into grooves 172 (Fig. 27H) near the distal most end of the hub 152 such that the slidable sleeve 156 is no longer slidable with respect to the needle hub 152 and the needle 122 remains completely covered to prevent accidental needle sticks. Though the safety needle 150 preferably has the above configuration, it is within the spirit and scope of the present invention that any suitable safety needle 150 can be used.

[00125] Figs. 29-36 illustrate yet another alternative safety needle applicable to the present invention. Figs. 29 and 30 show the general arrangement of a safety needle 1001 (Ie. the safety needle accessory and the needle 1003) of the type which may be used with the present invention as fitted to a male Luer taper connector 1004 with the end of the needle 1003 enclosed by the slidable sleeve 1005 of dispensing port 13. The slidable sleeve 1005 is prevented from longitudinal movement on the needle hub or hub 1007 by a locking ring 1013, which may be removed by pulling on the tab 1014. The removable locking ring 1013 may be connected to the needle hub 1007 and/or the slidable sleeve 1005. Although embodied in the drawings as cylindrical, the cylindrical shape of the needle hub 1007 and slidable sleeve 1005 may be replaced by triangular, rectangular or other shapes to suit the application.

[00126] Fig. 30 is a cross-section through the longitudinal axis of the safety needle 1001. The needle hub 1007 is cylindrical and terminates at the end which receives the dispensing port 13 with a conical section 1008, and is molded onto the needle 1003. The conical section 1008 has an inner female Luer cone 1024 which is shown frictionally attached to the male Luer cone 1004 of dispensing port 13 (the Luer system for attaching the needle 1003 to the dispensing port 13 can e.g., be of a taper friction fit or a screw thread, and both are included in the present invention). The cylindrical slidable sleeve 1005 shrouds the needle 1003 and the needle hub 1007, and is freely sliding on and guided by the needle hub 1007. At the receiving end (i.e. the end which receives the dispensing port 13) of slidable sleeve 1005, there are four cantilever arms 1009 which bear resiliently upon the surface 1018 of the conical section 1008. The slidable sleeve 1005 is free to slide on the needle hub 1007, but is temporarily prevented from doing so by the locking ring 1013. The locking ring 1013 is integrally molded with the slidable sleeve 1005 by a frangible joint 1015, and may be partially or wholly detached by pulling on the tab 1014 to break the frangible joint 1015. It is preferred that the ring 1013 remains attached to the slidable sleeve 1005 to reduce the number of discarded parts. In addition, the frangible joint provides a tamper-evident lock. Alternatively, the locking ring 1013 may be molded to the needle hub 1007 via a suitable frangible connection. When the locking ring 1013 is removed, as shown in Fig. 31 the slidable sleeve 1005 may be pushed in the direction of arrow X by acting on the face 1006, and moves relative to the needle hub 1007 to expose the needle 1003. As the slidable sleeve 1005 moves, the cantilever arms 1009 are forced outwardly by the surface 1018 of the conical section 1008. The cantilever arms 1009 are resilient and the reaction force against the surface 1018 produces a resultant force in the direction of arrow Y acting against arrow X, so that when the original force is removed, the slidable sleeve 1005 returns to cover the tip of needle 1003.

[00127] Since the resultant force is provided by the slidable sleeve 1005 itself, no separate spring, e.g. a helical spring, is required in this embodiment although a separate spring could be used if desired. Thus, the resultant force may be generated within the slidable sleeve 1005, for example by the slidable sleeve 1005 having an elastically deformable portion, and/or by the safety needle 1001 further comprising an elastically deformable member, such as a spring (not shown). [00128] As shown in Fig. 34, the cantilever arms 1009 may have pads 1017 or radially inwardly extending projections, which bear onto the surface 1018 and, by suitably designing the bearing surfaces of the pads 1017, various spring characteristics may be obtained. Although four cantilever arms 1009 are shown, any number of cantilever arms 1009 could be employed. At least one cantilever arm 1009 is required for this embodiment although two to six cantilever arms 1009, and preferably four cantilever arms 1009, are preferred.

[00129] Although the surface 1018 of the hub 1007 is exemplified by a conical surface, other embodiments may be used within the scope of the present invention. In Figs. 29-33 and 35, the surface 1018 is straight, i.e. substantially conical by which the applicant means sufficiently conical to generate a resultant force, however, the surface need not be straight as shown, but may be curved to give a more linear return rate. Thus, the force in the direction of arrow Y could be substantially constant over a reasonable working stroke of the slidable sleeve 1005. In addition, the whole surface 1018 of the receiving end of the needle hub 1017 need not be conical. In fact, just one tapered section, e.g. a tapered ridge, would be sufficient. The tapered section does not have to project from the surface of the needle hub 1007. The tapered section could also descend into the wall of the needle hub 1007, i.e. a tapered detent rather than a tapered ridge. Also, as described below with reference to Fig. 36, provided the slidable sleeve 1005 is suitably configured, a projection 1032 in the surface 1018 of the needle hub 1007 will suffice.

[00130] The different arrangements provide a great deal of design flexibility in the safety needle 1001. For example, the linearity of the return rate may be varied depending on the particular requirements for a particular application.

[00131] Referring to Figs. 31 and 32, when the slidable sleeve 1005 returns in direction Y, it travels slightly past its original starting position, so that the resilient pawl 1020 which was initially depressed by the surface 1025 of hub 1007, snaps out to act against face 1016 of the hub 1007. This ensures that the slidable sleeve 1005 cannot be pushed back toward the dispensing port 13, and therefore the needle 1003 is safely and securely covered. It is preferred that there is a pre-load between the cantilever arms 1009 and hub 1007 to ensure that the slidable sleeve 1005 is sufficiently biased in the direction of arrow Y to complete its full displacement potential. [00132] The slidable sleeve 1005 preferably has a first extended position or initial position where the slidable sleeve 1005 is able to be moved toward the receiving end of the needle hub 1007 and a second extended position where the slidable sleeve 1005 is in a locked position. The different start and finish positions of the slidable sleeve 1005 is achieved by a detent mechanism shown in Fig. 33, which is to be read in conjunction with Figs. 30-32. After the first two or three millimeters of movement, a detent integral with the slidable sleeve "switches" so that the return of the slidable sleeve 1005 trips a latching pawl, so that the slidable sleeve returns only to the "safe" position (position e); that is the pawl prevents the slidable sleeve 1005 from being moved toward the syringe a second time, and thus protects the tip of the needle. As part of the detent mechanism, an inside surface of the slidable sleeve 1005 has a pin 1010 which engages a sprag 1026 and a resilient pawl 1019 attached to the needle hub 1007 thereby holding the slidable sleeve 1005 in the first extended position and, in use, allowing the slidable sleeve 1005 to move into the second extended position. The pin 1010 is integral or attached to the slidable sleeve 1005. The sprag 1026, resilient pawl 1019, and recess 1027 are molded integrally with the needle hubs 1007, 1008, and the pin 1010 extends into the recess 1027, and is allowed to move freely except where controlled by the detent mechanism, as further described below, and the boundaries of the recess 1027. [00133] In the initial assembly of the safety needle 1001, the slidable sleeve 1005 is placed over the needle 1003 with pin 1010 proximate to the sprag 1026 (formed as part of the needle hub 1007) at position a (Fig. 33). As the slidable sleeve 1005 is moved further, the pin 1010 deflects the resilient pawl 1019, until the pin 1010 is trapped behind sprag 1026 at position b. In this position the slidable sleeve 1005 is trapped on the needle hubs 1007, 1008 and cannot be removed without applying considerable force. This is the position of the components as supplied to the end user, and the location of the locking ring 1013 takes account of this. With the locking ring 1013 removed, the slidable sleeve 1005 is pushed further toward the dispensing port 13, and the pin 1010 again deflects the resilient pawl 1019 until the pin 1010 reaches position c. The distance j defines the initial displacement of the slidable sleeve 1005, when starting the injection, and the tip of needle 1003 may be level with the face 1006 of slidable sleeve 1005. The slidable sleeve 1005 may now be moved toward the syringe until the pin 1010 reaches the end wall 1028 of the recess 1027 at position d. This position defines the maximum displacement of slidable sleeve 1005, and thus the maximum exposure of the needle 1003. At any time the force acting on slidable sleeve 1005 is removed, the slidable sleeve 1005 will return in the direction of arrow Y (Fig. 31) until pin 1010 reaches position e. The pin 1010 also helps prevent the removal of slidable sleeve 1005, but additionally the tooth 1021 is now proximate to face 1022 on a cantilever arm 1009 (see Fig. 32), which prevents the removal of the slidable sleeve 1005. In the final position, a pawl 1020 engages with face 1016 of hub 1007 and prevents the slidable sleeve 1005 from being moved. It should be noted that with the present diagrammatic presentation of the safety needle 1001, a small amount of rotational movement is necessary between the slidable sleeve 1005 and hub 1007 to permit the pin 1010 to move from position c to position e, but the rotation is preferably negligible.

[00134] The detent mechanism is interchangeable between the slidable sleeve 1005 and needle hub 1007 if required. Also, the detent mechanism described hereinabove is but one of a number of such mechanisms, the main requirement being to permit the following sequence of operation: permit the slidable sleeve 1005 to be moved sufficiently so that the opening 1002 in the slidable sleeve 1005 is level with or just in front of the tip of the needle 1003, at which position the detent must be activated so that if the displacing force on the slidable sleeve 1005 is removed, the slidable sleeve 1005 slides forward and locks, thus protecting the user from contact with the tip of the needle 1003. Typically, the tip of the needle 1003 would be about 3 mm back from the face of the opening 1002 in the slidable sleeve 1005 at the start, and 1 mm back from the face when the detent is activated. [00135] Fig. 35 shows the device 1001 as previously described, except that in this embodiment the needle 1003 is bonded into the outlet end of the dispensing port 13. The needle 1003 is free to pass through the needle hub 1007, and the conical section 1008 is adapted at 1031 to snap-fit over a projection 1030 to hold the device 1001 to the needle hub 1007. Alternatively, a more defined snap- fitting projection may be formed, the object being to make the safety needle 1001 difficult to remove after assembling it to the dispensing port 13.

[00136] Fig. 36 shows an alternative version of safety needle 1001 in which the needle hub 1007 is integral with the dispensing port 13. The slidable sleeve 1005 is then attached to the needle hub 1007 in the manner as described hereinbelow. The material of the needle hub 1007 is a drug- compatible material.

[00137] As mentioned hereinabove, Fig. 36 also shows the separate feature of the projection 1032 on the surface 1018 of the needle hub 1007 which may be used to deflect the slidable sleeve 1005 thereby generating the resultant force. This embodiment, i.e. incorporating the projection 1032, provides a highly non-linear return rate since the length of the slidable sleeve 1005 is effectively reduced as the slidable sleeve 1005 and the needle hub 1007 are slid together, thereby increasing the stiffness of the slidable sleeve 1005.

[00138] As an alternative to the tapered outer surface of the needle hub 1007, the slidable sleeve 1005 may have at least one cantilever arm 1009 (Fig. 30) which engages a helical track (not shown) on the outer surface of the needle hub 1007 such that, in use, as the needle 1003 is inserted into a patient, the at least one cantilever arm 1009 is displaced radially by the helical track on the outer surface of the needle hub 1007 thereby generating the resultant force. Thus, as the slidable sleeve 1005 is caused to move toward the receiving end of the needle hub 1007, one or more cantilever arms 1009 are forced to follow the direction of the helical tracks. Since the cantilever arms 1009 are resilient, a resultant force will be generated.

[00139] As an alternative to cantilever arms 1009, the receiving end of the slidable sleeve 1005 itself may have elastic properties such that, in use, as the needle 1003 is inserted into a patient, the resultant force is generated within the slidable sleeve 1005. By elastic properties the applicant means that the resultant force is generated within a radially continuous slidable sleeve, i.e. a sleeve without cantilever arms 1009. The elastic properties may be achieved by using an elastic material, such as an elastomeric polymer. Alternatively, the receiving end of the slidable sleeve 1005 may be concertinaed, with the ridges, of course, running parallel to the hollow needle 1003 . The elastic properties could also be generated using a circumambient spring (not shown) attached to the slidable sleeve 1005. [00140] As a further alternative, instead of the resultant force being generated in the slidable sleeve 1005 itself, the safety needle 1001 may incorporate an alternative, or additional, resultant mechanism, such as a helical spring. Such safety needles are exemplified in U.S. Patent Numbers US 4,911,693, US 4,813,940 and US 5,104,384.

[00141] Figs. 37-43a illustrate another alternative version of the safety needle 1001 in which the needle hub 1007 and the slidable sleeve 1005 are adapted to allow the slidable sleeve 1005 to be retracted into and held at an intermediate position (Fig. 40) between the extended position (Fig. 37) and the retracted position (Fig. 42) such that, in use, the tip of the needle 1003 projects partially from the slidable sleeve 1005, that is the needle bevel is exposed. In this intermediate position the locking mechanism is not engaged and hence the slidable sleeve 1005 may be retracted further into the (fully) retracted position as it is inserted into the patient. The advantages of this arrangement are that exposing the tip of the needle 1003 partially allows the user to position the needle 1003 more precisely on, for example, the patient's skin 1048, and also facilitates the aspiration of trapped air and excess drug. The use of a pack 1035 on the safety needle 1001 prevents needle stick injuries when the safety needle 1001 is in the intermediate position.

[00142] Fig. 37 shows the device as assembled by the manufacturer, and comprises a needle hub 1007, being of conical or other tapering form. The slidable sleeve 1005 has cantilever arms 1009 attached or integral, the arms 1009 terminating with an radially inwardly extending projection 1033, which engages with an undercut 1034 of the needle hub 1007, shown in greater detail in Fig. 37a. In the position shown, there is little load on the spring cantilever arms 1009, but sufficient to hold the components together. Referring to Fig. 38, this is a center-line cross-section through the safety needle 1001 assembled into its pack 1035. The pack 1035 is releasably mounted on the needle hub 1007 and slidable sleeve 1005. That is, the safety needle 1001 is held within the pack 1035, for example by friction, but may be removed by the user. To facilitate releasable mounting, the pack 1035 and safety needle 1001 have engageable portions which may simply be the surfaces of the pack 1035 and safety needle 1001. The surfaces may be textured or have projections. The pack 1035 is preferably tubular and is also preferably made from a deep-drawn vacuum formed plastic material. The pack 1035 is shown with a flange 1036 and open at the receiving end of the needle hub 1007, and closed at the injection end by the extension 1037. The inner face of shoulder 1038 rests on the end face of the slidable sleeve 1005. The needle hub 1007 has one or more projections 1039, which provide a light factional retaining force on the inside of the pack 1035 to prevent the safety needle 1001 from falling out. The safety needle 1001 may be further retained inside the pack 1035 by a releasable (peel-off) membrane 1040, which is preferably gas permeable. The membrane 1040 is bonded to flange 1036, and may be made from a porous material such as Tyvek^® which is spun- bonded high-density polyethylene available from DuPont and which is used extensively in pharmaceutical packaging to permit a sterilizing gas, such as ethylene oxide, to penetrate the pack 1035 while preventing ingress of bacteria during storage. Other peelable materials may be used according to the sterilization process used. The membrane 1040 may have a tag 1041 to assist in removal. The needle hub 1007 has a syringe adaptor 1024 which may be configured to suit the common Luer taper or threaded Luer lock nozzles.

[00143] Referring to Fig. 39, to assemble the safety needle 1001 to a dispensing port 13, the user removes the peelable membrane 1040 by pulling on tag 1041. Holding the pack 1035, the user pushes the adaptor 1024 of the needle hub 1007 in the direction of the arrow X onto the dispensing port 13. This causes the inner face of the shoulders 1038 to press against the surface of slidable sleeve 1005 which moves toward the dispensing port 13. The injection end of the pack 1035 has an extension 1037 which is capable of housing the tip of the needle 1003 in the intermediate position and the shoulders 1038 of the extension 1037 abut against the injection end of the slidable sleeve 1005 thereby causing the slidable sleeve 1005 to move in to the intermediate position when the pack 1035 is caused to move toward the receiving end of the needle hub 1007. At the same time, the cantilever arms 1009 are forced outwardly as they travel up the surface of the needle hub 1007, until the small shoulder 1044 on the slidable sleeve 1005 reaches a projection 1045 on the needle hub 1007, thus preventing further movement. At or about this point, at least one of the projections 1033 of the arms 1009 snaps over a catch 1046 on the needle hub 1007. The cantilever arms 1009 are now loaded radially, and exerting a resultant force urging the slidable sleeve 1005 off the needle hub 1007. The pack 1035 may now be removed, and catch 1046 prevents the slidable sleeve 1005 from moving with respect to the needle hub 1007 through the resultant force of the cantilever arms 1009. With the pack 1035 removed, the safety needle 1001 appears as shown in Fig. 40, and is ready for use. The needle tip 1003 is thus partially exposed, i.e. the bevel of the needle may be seen by the user projecting from the slidable sleeve 1005, and the user may aspirate trapped air and excess drug. Fig. 41 shows the safety needle 1001 ready for use position, as in Fig. 12, but with an extension 1047 on face of slidable sleeve 1005 extended to partially shroud the tip of the needle 1003, which will afford more protection to the user and the patient prior to injection.

[00144] Referring to Figs. 42 and 42a, the user then pushes the needle 1003 in the direction of arrow A through the patient's epidermis 1048 and into the subcutaneous tissue 1049, which brings the face of the slidable sleeve 1005 into contact with the stratum corneum of the patient's epidermis 1048. Further movement in the direction of arrow A pushes the slidable sleeve 1005 toward the dispensing port 13, and thus the cantilever arms 1009 are forced further outwardly by the conical surface of the needle hub 1007. At the same time, the end of at least one cantilever arm 1009 is forced against a cam 1050 which causes the slidable sleeve 1005 and cantilever arms 1009 to rotate in the direction of arrow B, until the ends of the cantilever arms 1009 drop into grooves 1051. The grooves 1051 have a slope toward the needle 1003, which maintains the resultant force of the cantilever arm 1009. At this point, (which represents only a millimeter or two of movement of the slidable sleeve 1005), if the needle 1003 is withdrawn from the patient, the resultant force of the cantilever arms 1009 urges the slidable sleeve 1005 toward the tip of the needle 1003 until the tip of the needle 1003 is shielded by the slidable sleeve 1005. At the end of travel of the cantilever arms 1009, projections 1033 on the cantilever arm 1009, which are still sliding in the grooves 1051, drop into the holes 1052 in the hub 1007. This locks the slidable sleeve 1005 in position and prevents the slidable sleeve 1005 from being pushed back toward the dispensing port 13, or being pulled off the needle hub 1007. This position is shown in Figs. 43 and 43a, the latter being a section through the center-line, and the safety needle 1001 rotated to show the grooves 1051 and holes 1052, with the projections 1033 on the cantilever arms 1009 located within the holes 1052. Although the lockably engaging projections 1033 and holes 1052 are shown with reference to cantilever arms 1009, any slidable sleeve 1005 may be locked into the extended position using one or more projections 1033 and corresponding one or more holes 1052. Such an arrangement results in a less complex, and hence less costly, safety needle 1001 and avoids introducing opposing frictional and/or detent forces which result from an integral but independent locking mechanism. An advantage of the projection 1033/hole 1052 mechanism is that this locking mechanism provides substantially no resistance against the resultant force as the slidable sleeve 1005 moves from the retracted position to the extended position. When the slidable sleeve 1005 reaches the extended position the locking mechanism engages which then resists the resultant force.

[00145] The pack 1035 confers safe storage and handling advantages, allows the safety needle 1001 to be assembled to a dispensing port 13 without risking premature operation of the safety mechanism, and does not add to the overall cost of the device, since it is similar to the vacuum- formed covers already in use for needles and syringes. For the user, the operation of the safety needle 1001 is practically identical to the use of a standard needle.

[00146] It is preferable that the coefficient of friction between the slidable sleeve 1005 and the needle hub 1007 is low, so that the resultant biasing force to return the slidable sleeve 1005 is not compromised by "stiction", or so high that the force required on the patient's skin to deflect the slidable sleeve 1005 is excessive. This may be achieved by careful selection of materials. Such materials are known in the art, for example, the needle hub could be made from a high-density polyethylene or similar drug-compatible plastics material, and the slidable sleeve 1005 from an inexpensive plastics material such as polycarbonate, polystyrene, polyester or PVC. A more expensive, highly creep-resistant plastics material, for example polyphenylene sulfone, could also be used. As an alternative, the slidable sleeve 1005, or just the at least one cantilever arm 1009, may be made from metal, preferably stainless steel. The metal would be fabricated sufficiently thinly to provide the required elastic properties. If necessary, a lubricant may be used, or a lubricant may be incorporated with the polymers. Generally the materials should be suitable for sterilization by gamma radiation, but it is possible to select materials compatible with sterilization by steam or other gas, such as ethylene oxide.

[00147] In a preferred embodiment, the slidable sleeve 1005, prior to use, is not under any substantial load. Any substantial load indicates a load which is sufficient to cause the material of the slidable sleeve 1005 to undergo creepage during storage at ambient temperature. [00148] Figs. 44 and 45 show yet another alternative safety needle 1101 for connecting with the fluid control device of the present invention. The safety needle 1101 includes a needle hub 1107 and a slidable sleeve 1105 that are adapted to allow the slidable sleeve 1105 to be retracted into and held at an intermediate position (not shown) while the needle 1103 is still contained within the pack 1135. This alternative safety needle 1101 allows the safety needle 1101 to be stored without any substantial load on the slidable sleeve 1105 thereby preventing creepage during storage. [00149] Fig. 44 shows a center-line cross-section through the safety needle 1101 assembled into its pack 1135 and Fig. 45 shows a perspective view of the needle hub 1107. The pack 1135 is releasably mounted on the needle hub 1107 and slidable sleeve 1105. The pack 1135 is preferably tubular and is also preferably made from a deep-drawn vacuum formed plastic material. The pack 1135 is shown with a flange 1136 and open at the receiving end of the needle hub 1107, and closed at the injection end by the extension 1137 defined by a plurality, e.g. six, ribs 1153. The ribs 1153 rest on the end or distal face of the slidable sleeve 1105. The needle hub 1 107 has one or more projections 1139, which provide a light frictional retaining force on the inside of the pack 1135 to prevent the safety needle 1101 from falling out. The pack 1135 may also have a partially textured internal surface 1154 which engages the projections 1139 in order to prevent rotation of the safety needle 1101 within the pack 1135. The safety needle 1101 may be further retained inside the pack 1135 by a releasable (peel-off) membrane 1140 as described in the above embodiment. The needle hub 1107 has an adaptor 1124 which may be configured to suit the common Luer taper or threaded Luer lock nozzles. [00150] In the position shown in Fig. 44, the safety needle 1101 is as assembled by the manufacturer. The slidable sleeve 1105 has cantilever arms 1109 attached or integral, the arms 1109 each terminating with a projection 1133, which engages with indent 1155 of the needle hub 1107. The indent 1155 is of sufficient depth that the cantilever arms 1109 are under substantially no load, i.e. the sleeve 1105 is not radially expanded. In this position, the slidable sleeve 1105 is prevented from sliding off the needle hub 1107 by the pack 1135 and the engagement between the projection 1133 on the cantilever arms 1109 and the indent 1155 on the hub 1107.

[00151] To assemble the safety needle 1101 to a dispensing port (not shown), the user removes the peelable membrane 1140 by pulling on tag 1141. Holding the pack 1135, the user pushes the adaptor 1124 of the needle hub 1107 onto the dispensing port. This causes the inner face of the ribs 1153 to press against the distal face of slidable sleeve 1105 which moves toward the dispensing port. The injection end of the pack 1135 is capable of housing the tip of the needle when the safety needle 1101 is in the intermediate position. The ribs 1153 of the pack 1135 abut against the injection end of the slidable sleeve 1105 thereby causing the slidable sleeve 1105 to move in to the intermediate position when the pack 1135 is caused to move towards the receiving end of the needle hub 1107. The indent 1155 has a tapering interior surface which causes the sleeve 1105 to expand radially outwardly as the sleeve 1105 is caused to move up the surface of the needle hub 1107. The sleeve 1105 is caused to move until the sleeve 1105 is in the intermediate position wherein the tip of the needle 1103 is partially exposed. At or about this point, at least one of the projections 1133 snaps over a catch 1156 on the needle hub 1107. The cantilever arms 1109 are now loaded radially, and exerting a resultant force urging the slidable sleeve 1105 down the needle hub 1107. This resultant force is countered by the catch 1156 on the hub 1 107. The pack 1135 may now be removed, and catch 1156 prevents the slidable sleeve 1105 from sliding down the needle hub 1107 through the resultant force in the cantilever arms 1109. With the pack 1135 removed, the safety needle 1101 is ready for use. The tip of the needle 1103 is thus partially exposed i.e., the bevel of the needle 1103 may be seen by the user projecting from the slidable sleeve 1105, and the user may aspirate trapped air and excess drug.

[00152] Once the safety needle 1 101 is in the intermediate position and the pack 1135 is removed, the user then pushes the needle 1103 through the patient's epidermis 1048 and into the subcutaneous tissue 1049, which brings the face of the slidable sleeve 1105 into contact with the stratum corneum of the patient's epidermis 1048 (see Fig. 42). Further movement of the needle 1103 into the patient's skin pushes the slidable sleeve 1105 toward the dispensing port, and thus the cantilever arms 1109 are forced further outwardly by the conical surface of the needle hub 1107. At the same time, the end of at least one cantilever arm 1109 is forced against a cam 1157 on the hub 1107 which causes the slidable sleeve 1105 and cantilever arms 1109 to rotate (in an analogous manner to Fig. 43), until the ends of cantilever arms 1109 are directed along a guide 1158. As shown in Fig. 45, the catch 1156 and the cam 1157 are preferably formed into a single structure. The projections 1133 follow guides 1158 as the sleeve 1105 is caused to retract. As the sleeve 1105 retracts, the sleeve 1105 is deflected radially outwardly by the sloping of the hub 1107 toward the needle 1103.

[00153] At this point, (which represents only a millimeter or two of movement of the slidable sleeve 1105), if the safety needle 1101 is withdrawn from the patient, the resultant force of the cantilever arms 1109 urges the slidable sleeve 1105 toward the tip of the needle 1103 until the tip of the needle 1103 is shielded by the slidable sleeve 1105. At the end of travel of the projections 1133 and the cantilever arms 1109, the projection 1133 on the cantilever arms 1109, which are still following the guides 1158, drop into the opening 1159. This locks the slidable sleeve 1105 in position and prevents the slidable sleeve 1105 from being pushed back toward the dispensing port, or being pulled off the needle hub 1107.

[00154] The opening 1159 is shown further toward the injection end of the hub 1107 than the indent 1155. This allows the opening 1159 to be a circumferentially continuous hole which permits free rotation of the sleeve 1105 around the hub in the locked position. The free rotation provides a more secure locked position. In a simple hole/projection arrangement, accidental rotation of the sleeve 1105 might distort the sleeve 1105 sufficiently to disengage the hole 1159 and projection 1133. Allowing free rotation means that the rotation is not resisted preserving the integrity of the locking mechanism.

[00155] Referring to Figs. 46-49, an alternative version of the packing sleeve or pack, generally designated 1235, is shown for use with a medical device, preferably the safety needle 1101 as shown in Figs. 44-45 and described above. In addition to the above described features, the safety needle 1101 may include a circular retaining ring (not shown) disposed around the cantilever arms 1109 of the slidable sleeve 1105 to retain the slidable sleeve 1105 on the needle hub 1107. The pack 1235 prevents the safety needle 1101 from being removed from the pack 1235 without first activating or priming the safety needle 1101 to move the safety needle 1101 from the initial position to the intermediate position.

[00156] The pack 1235 includes a generally hollow body 1270 having a distal end 1270a and an open proximal end 1270b. The body 1270 surrounds at least a portion of the safety needle 1101, preferably the entire safety needle 1101, and the open proximal end 1270b is initially preferably covered by a releasable membrane 1240 such that the safety needle 1101 is sealed within the pack 1235. The membrane 1240 is bonded to a flange 1272 extending radially outwardly from the body 1270 proximate the proximal end 1270b. The membrane 1240 is preferably gas permeable and may be made from a porous material such as Tyvek^® which is spun-bonded high-density polyethylene, which is used extensively in pharmaceutical packaging to permit a sterilizing gas, such as ethylene oxide, to penetrate the pack 1235 while preventing ingress of bacteria during storage. Other peelable materials may be used according to the sterilization process used. The membrane 1240 may have a tab or tag (not shown) to assist removal. The body 1270 is preferably tubular and is made from a deep-drawn vacuum formed polymeric material, but the body 1270 may have any shape, such as rectangular and may be comprised of any suitable material. [00157] Referring to Figs. 46 and 48, the body 1270 has at least one, and preferably four tracks 1274 that extend radially outwardly into the body 1270 proximate the proximal end 1270b of the body 1270. However, the tracks 1274 may extend radially inwardly from the body 1270 or be formed by ridges that extend radially inwardly from the body 1270. It is preferred that the tracks 1274 be equally circumferentially spaced around an interior surface 1270c of the body 1270 that correspond to the plurality of members or projections 1139 extending from the needle hub 1107. Though it is preferred that the projections 1139 engage with the corresponding tracks 1274, the member or projection 1139 may be any portion of the needle hub 1107 in contact with the body 1270. The tracks 1274 are in sliding engagement with the projections 1139 such that the motion of the needle hub 1107 relative to the body 1270 is dictated by a path the projections 1139 follow along the tracks 1274 while the slidable sleeve 1105 is prevented from moving toward the distal end 1270a of the body 1270 by a ledge 1253. The ledge 1253 is preferably comprised of a plurality of ribs 1253a that form a cavity 1237 for receiving the needle 1103 when the safety needle 1101 is in the intermediate position.

[00158] The tracks 1274 each have an activation leg 1276 and a releasing leg 1278. The activation leg 1276 is preferably slanted or angled with respect to a longitudinal axis L of the body 1270 such that the activation leg 1276 has a horizontally extending direction. Alternatively, the activation leg 1276 may be stepped such that the vertical and horizontal directions are separated. The activation leg 1276 preferably has a retaining bump 1280 (Fig. 46) that extends generally parallel to the longitudinal axis L of the body 1270 and projects radially inwardly from the track 1274 and is proximate a first end 1276a of the activation leg 1276. The activation legs 1276 also each preferably have an assembly path 1282. The assembly paths 1282 and the first ends 1276a of the activation legs 1276 are preferably separated by a ramp 1284 that is inclined toward the distal end 1270a of the body 1270. The assembly paths 1282 are preferably generally triangular in shape and encompass portions of the proximal end 1270b between the releasing legs 1278, such that during assembly, the projections 1139 extending from the needle hub 1107 are directed toward and aligned with the corresponding ramps 1284. The assembly paths 1282 help to ensure that the safety needle 1101 is properly inserted into the body 1270. The projections 1139 are then urged over the ramps 1284 with a predetermined amount of force such that the projections 1139 snap fit into the first ends 1276a of the activation legs 1276 and the ramps 1284 and the retaining bumps 1280 retain the projections 1139 within the first ends 1276a of the activation legs 1276. [00159] The body 1270 preferably includes at least one, and preferably four, retaining ribs 1286 between the tracks 1274 and the distal end 1270a of the body 1270. The retaining ribs 1286 preferably extend the length of cantilever arms 1109 but the retaining ribs 1286 may extend any length so long as they are proximate the cantilever arms 1109 when the safety needle 1101 is in the initial position. The retaining ribs 1286 preferably extend in the axial direction and project radially inwardly from the interior surface 1270c of the body 1270. Each retaining rib 1286 is preferably circumferentially aligned with the first end 1276a of a respective activation leg 1276 such that each retaining rib 1286 is proximate and circumferentially aligned with a respective cantilever arm 1109 when the safety needle 1101 is in the initial position. The retaining ribs 1286 are preferably spaced between, or unaligned with, the cantilever arms 1109 when the safety needle 1101 is moved out of the initial position (i.e. twisted relative to the packing sleeve 1235) as described further below. [00160] Referring to Figs. 48 and 49, the safety needle 1101 is inserted into the body 1270 in an initial position and is not removable from the body 1270 in this position once assembled (Fig. 48). The retaining ribs 1286 prevent the slidable sleeve 1105 from unintentionally moving relative to the hub 1107 and out of the initial position. For example, if the pack 1235 is dropped on the proximal end 1270b or is otherwise jolted, the slidable sleeve 1105 is prevented from sliding toward the proximal end 1270b of the body 1270 because any deflection of the cantilever arms 1109 is limited by the retaining ribs 1286. As a result, the slidable sleeve 1105 preferably cannot move until the cantilever arms 1109 are twisted out of alignment with the retaining ribs 1286. To remove the body 1270 from the safety needle 1101 or other injection or medical device, the user must twist the needle hub 1207 relative to the body 1270 with a predetermined amount of torque such that the projections 1139 snap over the retaining bumps 1280. The retaining bumps 1280 also ensure that the safety needle 1101 is fully secured to the dispensing port because the projections 1139 will not have sufficient predetermined circumferential twisting force to overcome the retaining bumps 1280 until the safety needle 1101 is fully twisted onto the dispensing port. For example, if a user fails to fully tighten the safety needle 1101 onto the dispensing port, when the user goes to remove the pack 1235, the pack 1105 and safety needle 1101 will twist together with respect to the dispensing port until the threaded or luer connection between the safety needle 1101 and the dispensing port is fully engaged. Once the safety needle 1101 can no longer be twisted relative to the dispensing port the user will continue twisting the pack 1235 until the twisting force surpasses the predetermined amount of torque such that the projections 1139 snap or slide over the retaining bumps 1280 and the pack 1235 twists relative to the safety needle 1101 and dispensing port. Though it is preferred that the retaining bumps 1280 extend generally parallel to the longitudinal axis L of the body 1270, the retaining bumps 1280 may be positioned generally perpendicular to the longitudinal axis L or at an angle to the longitudinal axis L so that the initial movement of the needle hub 1107 with respect to the body 1270 is at least partially toward the distal end 1270a of the body 1270. [00161] After the initial twist, or other movement to overcome the retaining bumps 1280, the user then urges the needle hub 1107, or whatever the needle hub 1107 may be connected to, toward the distal end 1270a of the body 1270. Pushing the needle hub 1107 toward the distal end 1270a of the body 1270 causes the projections 1139 to follow the paths of the activation legs 1276 such that the needle hub 1107 twists and the needle hub 1107 advances toward the distal end 1270a. Twisting of the needle hub 1107 also twists the slidable sleeve 1105 such that the cantilever arms 1109 are unaligned with the retaining ribs 1286 and therefore enabling the cantilever arms 1109 to move in the radial direction as the slidable sleeve 1105 slides over the needle hub 1107. Similar to an above described embodiment, urging the needle hub 1107 toward the distal end 1270a causes the needle hub 1107 to slide up into the cantilever arms 1109 of the slidable sleeve 1105 and into the activated or intermediate position (Fig. 49, shown without ribs 1286). In order to remove the body 1270 from the safety needle 1101, the projections 1139 must first follow the path set forth by the activation legs 1276. The activation legs 1276 terminate at a second end 1276b at which point the safety needle 1101 is in the activated or intermediate position. The releasing legs 1278 extend in a direction that is generally parallel with the longitudinal axis L of the body 1270 from the second ends 1276b such that once the projections 1139 reach the second ends 1276b and the safety needle 1101 is in the intermediate position, the projections 1139 may be pulled along the releasing legs 1278 and out of the body 1270. The tracks 1274 prevents the user from having to remember to push the safety needle 1101 toward the distal end 1270a of the body 1270 to set the safety needle 1101 in the intermediate position before removing the body 1270 because the body 1270 cannot be removed from the safety needle 1101 until the safety needle 1101 is set in the intermediate position. [00162] Referring to Figs. 50-54J, there is shown yet another alternative safety needle, generally designated 1301. The safety needle 1301 is similar to the previously described embodiments and similar numbering has been used to indicate similar elements. The safety needle 1301 differs from the other embodiments as set forth below. The safety needle 1301 is for automatically covering a tip 1303a (Fig. 54E) of a needle 1303 following removal of the needle 1303 from the epidermis and subcutaneous tissue, generally referred to as skin of a patient (not otherwise shown). [00163] Referring, to Figs. 50 and 54J, the hollow needle 1303 has a longitudinal axis (not shown) that extends along the length of the needle 1303. A needle hub (hub) 1307 is mounted onto aportion of the needle 1303 and has an outer surface 1318, a receiving end 1307b distal to the tip 1303a of the needle 1303 and an injection end 1307a proximal to the tip 1303a of the needle 1303. The needle hub 1307 also includes one or more projections 1339, similar to those of projections 1139 of needle hub 1107, for engagement with tracks 1274 (Fig. 54A), as further described below. The hub 1307 is preferably co-molded or affixed to the needle 1303 with an epoxy or other fastening device or substance such that the safety needle 1301 can be mounted to a dispensing port 13 (Fig. 1). However, the safety needle 1301 may be mounted over a needle that is already affixed to the dispensing port 13 during use. The injection end 1307a of the hub 1307 preferably includes at least one and preferably four equally spaced recesses 1359 extending radially inwardly. The recesses 1359 can also be configured as a circumferential slot, such as slot 1159, as described above. At least a portion of the outer surface 1318 of the hub 1307 tapers inwardly toward the injection end 1307a. The hub 1307 is preferably at least partially frusto-conical in shape such that the outer surface 1318 has a straight line taper, but the outer surface 1318 can be concavely tapered or tapered in some other manner.

[00164] The hub 1307 preferably includes at least one and preferably four ramped indents 1355. The hub 1307 also preferably includes at least one and preferably four catches 1356 spaced axially from the ramped indents 1355. Each catch 1356 preferably includes a cammed surface 1357 axially extending from the catch 1356. Axially extending guides 1358 preferably extend from the cammed surfaces 1357. The cammed surface 1357 and guides 1358 form a helical track as described further below.

[00165] Referring to Figs. 51 and 52, the outer surface 1318 of the hub 1307 decreases in radial dimension from the needle 1303 moving circumferentially from each catch 1356 such that the outer surface 1318 is partially flattened between each catch 1356. The outer surface 1318 is preferably convex in the circumferential direction and has a radius of curvature that is larger than or about the same distance from the needle 1303 to the outer surface 1318, but the outer surface 1318 may have any shape such an concave. The outer surface 1318 of the hub 1307 is preferably convexly and smoothly shaped to ensure smooth operation as described further below. [00166] Referring to Figs. 51 and 53, the hub 1307 includes at least one and preferably four circumferentially spaced indicator markings 1364. The indicator markings 1364 are visual marks that are preferably circumferentially inline with the ramped indents 1355 and are between each of recesses 1359 or at least between the ramped indents 1355 and the injection end 1307a of the hub 1307. The indicator markings 1364 are preferably a green colored sticker that is affixed to the hub 1307 by an epoxy, but the indicator markings 1364 can be any marking that is visually distinguishable from the hub 1307, such as a textured surface, paint, a light, a reflector or co-molded material.

[00167] Referring to Figs. 50 and 51, a slidable sleeve 1305 is slidably mounted to the hub 1307. The slidable sleeve 1305 has a mounting end 1305b distal to the tip 1303a of the needle 1303 and an injection end 1305a proximal to the tip 1303a of the needle 1303. The slidable sleeve 1305 preferably includes a nose cone 1362 and at least one and preferably four resilient cantilever arms 1309. The cantilever arms 1309 extend in the axial direction and have a resilient flexure in the radial direction. The cantilever arms 1309 are preferably equally spaced circumferentially from each other, but may be asymmetrically spaced or joined together such that the slidable sleeve 1305 forms an enclosed sheath. The cantilever arms 1309 are preferably joined by a ring 1309a that is then mounted into the nose cone 1362. However, the cantilever arms 1309 may be integrally formed with the nose cone 1362 without the need for the ring 1309a. The nose cone 1362 has a needle hole 1362a. The material surrounding the needle hole 1362a preferably extends axially into the nose cone 1362 such that an axially extending dip 1362b is formed around the needle hole 1362a inside of the nose cone 1362. Each cantilever arm 1309 preferably includes a projection or foot 1333 extending radially inwardly proximate the mounting end 1305a of the slidable sleeve 1305. Each foot 1333 preferably has an enlarged end such that each foot 1333 has an enlarged distal width 1333b and a reduced proximal width 1333a (see Figs. 51 and 52). Each foot 1333 is in sliding contact with the outer surface 1318 of the hub 1307 during use.

[00168] The tip 1303a of the needle 1333 is located inside the slidable sleeve 1305 when the slidable sleeve 1305 is in the extended position (Fig. 53) and the tip 1303a of the needle 1303 projects from the slidable sleeve 1305 when the slidable sleeve 1305 is in the retracted position (Figs. 54F and 54G). The feet 1333 are mounted within the corresponding ramped indents 1355 in an initial position (Fig. 50). The initial position is preferably axially between the retracted and the extended positions, but the extended position may be between the initial position and the retracted position such that the slidable sleeve is held more securely in the extended position. The outer surface 1318 of the hub 1307 deflects the feet 1333, and correspondingly, the slidable sleeve 1305, outwardly in a radial direction as the slidable sleeve 1305 slides axially toward the receiving end 1307b of the hub 1307.

[00169] Referring to Figs. 54A-54J, the safety needle 1301 is preferably initially sealed within a pack 1235 described above (Figs. 54A-54D). The pack 1235 must be first moved further over the hub 1307 before the pack 1235 can be removed from the safety needle 1301 (Figs. 54C-54D). Removing the pack 1235 urges the slidable sleeve 1305 over the hub 1307 such that the feet 1333 are urged along the ramped indents 1355 and into the catches 1356. The catches 1356 retain the slidable sleeve 1305 in an intermediate position (Fig. 54E). The tip 1303a of the needle 1303 preferably extends slightly from the slidable sleeve 1305 in the intermediate position though the tip 1303a may be partially shrouded or entirely covered. The slidable sleeve 1305 is preferably spring biased against the hub 1307 in the intermediate position. The tip 1303a of the needle 1303 is then injected into the skin 1048 (Figs. 54F and 54G). The needle 1303 may extend into the skin 1048 and into the subcutaneous tissue 1049 depending on the type of injection. The needle 1303 may have a predetermined maximum exposed length to prevent over insertion into the skin 1048. As the needle 1303 extends into the skin 1048 the skin 1048 abuts against the injection end 1305a of the slidable sleeve 1305 generating a displacement force in the axial direction. The displacement force urges the slidable sleeve 1305 axially with respect to the hub 1307 such that the feet 1333 contact the cammed surfaces 1357 and twist the slidable sleeve with respect to the hub 1307. The decrease of the radial dimension of the hub 1307 causes the feet 1333 to twist further away from the catches 1356 such that the feet 1333 are preferably spaced between the catches 1356 (see Figs. 52, 54F and 54G). The radially outwardly extending guides 1358 prevent the slidable sleeve 1305 from twisting too far in either circumferential direction if an external force twists the slidable sleeve 1305 relative to the hub 1307. However, the cammed surfaces 1357 and the guides 1358 may be omitted such that the direction of the feet 1333 is dictated only by the slope of the outer surface 1318 of the hub 1307. Alternatively, the guides 1358 may be more narrowly positioned to form a helical track that the feet 1333 more closely follow. As the feet 1333 slide toward the retracted position, a restoring force is generated within the slidable sleeve 1305 due to the radial expansion of the cantilever arms 1309. Once the feet 1333 are circumferentially spaced from the catches 1356 the restoring force urges the slidable sleeve 1305 to move toward the injection end 1307a of the needle hub 1307 down the outer surface 1318 of the hub 1307 and into the extended position upon removal of the displacement force (i.e. withdraw of the needle 1303 from the skin 1048). The feet 1333 then slide into and are retained within the respective recess 1359 in the extended position to "lock" the slidable sleeve 1305 over the tip 1303a of the needle 1303 to prevent reuse and/or an accidental needle stick of the needle 1303. [00170] Referring to Fig. 53, in the extended position, at least one of the indicator markings 1364 is visible between at least two of the cantilever arms 1309 to ensure to the user that the safety needle 1301 is in the extended position and can be safely disposed of. The indicator marking 1364 is preferably covered in the initial and intermediate positions. Alternatively, an additional indicator marking may be provided to indicate that the slidable sleeve 1305 is in the intermediate position Such a configuration may be obtained by requiring a twist of the slidable sleeve 1305 relative to the hub 1307 between the initial and intermediate positions. Alternatively further, the indicator marking 1364 may only be visible in the initial and intermediate positions and covered in the extended position to indicate that the safety needle 1301 is not locked and ready for use. [00171] Referring to Figs. 54H-54J, once the safety needle 1301 is in the extended position, urging the slidable sleeve 1305 in a radial direction causes the needle hole 1362a to unalign with the tip 1303a of the needle 1303 and dispose the tip 1303a in the dip 1362b. In this tilted position, the sharpened tip 1303a may also extend into the polymeric material of the slidable sleeve 1305 to further ensure that the needle 1303 cannot be resused.

[00172] The slidable sleeve 1305 preferably has little or no load in the initial position to reduce the cantilever arms from creeping. However, the slidable sleeve 1305 may have a degree of biasing force on the hub 1307 in the initial position. A resilient biasing ring (not shown) may be mounted over the mounting end 1305b of the slidable sleeve 1305 to add a biasing force or the recesses 1359 may be positioned between the initial and intermediate positions. Alternatively, the ramped indents 1355 may be recessed toward the needle 1303 more than the recesses 1359 such that the slidable sleeve 1305 is initially not under any substantial load but the slidable sleeve 1305 is biased against the hub 1307 in the extended position. Additionally, the recesses 1359 or the injection end 1307a of the hub may extend varying radial lengths from the needle 1303 or axially offset such that the slidable sleeve is automatically tilted in the extended position to prevent the tip 1303a from aligning with the needle hole 1362a.

[00173] Figs. 55-57 illustrate another alternative safety needle 2101 applicable to the fluid control devices described above. The safety needle 2101 is substantially similar in structure and operation as that of the safety needle 1101 described above, except as further noted below. [00174] The safety needle 2101 includes a slidable sleeve 2105, a hub 2107, and a pack 2135. The slidable sleeve 2105 is substantially the same as described above for slidable sleeve 1105 and includes cantilever arms 2109. The hub 2107 is substantially the same as described above for hub

1107 and includes indents 2155, catches 2156, and guides 2158.

[00175] The safety needle 2101 differs from safety needle 1101 in that the initial position of the safety needle 2101 is shown in Fig. 55. That is, in the initial position, the needle 2103 is partially exposed out from the distal end of the slidable sleeve 2105. Thus, the initial position of the safety needle 2101 is essentially equivalent to the intermediate position of safety needle 1101. In addition, the final position or needle shield position for the safety needle 2101 is substantially the same as for safety needle 1101. However, unlike safety needle 1101, the safety needle 2101 has no intermediate position.

[00176] The pack 2135, as best shown in Fig. 56, is configured to house the safety needle 2101 in the initial position. Thus, upon the removal of the pack 2135, the safety need 2101 is in the ready for injecting position.

[00177] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention.

Claims

CLAIMS What is claimed is:

1. A fluid control device comprising: a first port; a second port to receive a syringe; a third port that includes an adaptor having a fluid conduit member extending into an interior of a medicinal vessel attached to the adaptor; a flow control member displaceable between first and second flow control positions enabling flow paths between pairs of ports of the first, second, and third ports; and a safety needle connected to the first port that includes: a needle, a hub at least partially surrounding and mounted to the needle and connected to the first port such that the needle is in fluid communication with the first port, a slidable sleeve mounted on the hub and in direct sliding engagement with the hub in an axial direction, the slidable sleeve having a radially elastically deformable portion, and the hub having a radially converging or diverging portion, wherein the slidable sleeve is slidable in a first axial direction between a first position to fully or substantially fully surround the needle and a second position to expose the needle, wherein sliding between the first and second positions causes deformation of the radially elastically deformable portion, and wherein the slidable sleeve is slidable in a second axial direction between the second position and a third position to fully surround the needle, the force to slide the slidable sleeve in the second axial direction being provided by the radially elastically deformable portion.

2. The fluid control device of claim 1, wherein the adaptor is integrally formed with the flow control member to form an integrally formed control member.

3. The fluid control device of claim 1, wherein the integrally formed control member includes a frangible portion enabling a forced non-reversible detachment of the adaptor from the flow control member.

4. The fluid control device of claim 1, wherein the adaptor is connected to the flow control member by a coupling enabling detachment of the adaptor from the flow control member.

5. The fluid control device of claim 1, wherein the flow control member is configured to rotate about a central axis of the third port to move between the first and second flow control positions.

6. The fluid control device of claim 1 , wherein the adaptor further includes a venting conduit extending into the medicinal vessel.

7. The fluid control device of claim 6, wherein the venting conduit includes an in-line filter.

8. The fluid control device of claim 1 , wherein the second port includes an in-line filter.

9. The fluid control device of claim 1 , further comprising a fourth port that includes: a second adaptor having a second fluid conduit member extending into an interior of a second medicinal vessel attached to the second adaptor; and a second flow control member displaceable between third and fourth flow control positions enabling flow paths between pairs of ports of the first, second, third and fourth ports.

10. A fluid control device comprising: a first port; a second port to receive a syringe; a third port that includes an adaptor having a fluid conduit member extending into a medicinal vessel attached to the adaptor; a flow control member connected to the adaptor and displaceable between first and second flow control positions respectively enabling flow paths between pairs of the first, second and third ports; a safety needle that includes: a needle in communication with the first port, a needle hub at least partially surrounding the needle, and a sleeve slidable configured to slide relative to the needle hub between an initial position, an intermediate position, a retracted position, and an extended position; a pack that includes a camming member, wherein the pack initially covers the needle, needle hub, and slidable sleeve; and an activation device for activating the safety needle that includes: a base mounted to the fluid control device, and a camming surface on the base, wherein the camming surface operatively engages the camming member to move the pack proximally and to move the slidable sleeve into the intermediate position.

11. The fluid control device of claim 10, wherein the pack further comprises: a generally hollow body surrounding at least a portion of the safety needle, the hollow body including: a longitudinal axis, a distal end, an open proximal end, and at least one track configured proximate the open proximal end, the at least one track having: an activation leg, a releasing leg, wherein the at least one track being in sliding engagement with at least one member extending from the needle hub such that the motion of a portion of the safety needle relative to the body is dictated by a path that the at least one member follows along the respective at least one track, the safety needle being in the initial position when the at least one member is proximate to a first end of the activation leg and in the intermediate position when the at least one member is proximate to a second end of the activation leg, the releasing leg extending from the second end of the activation leg and allowing the at least one member to be slid toward and then removed from the proximal end of the body.

12. The fluid control device of claim 10, wherein the pack further comprises a generally hollow body surrounding at least a portion of the safety needle when in the initial and intermediate positions, and wherein the generally hollow body is configured to only be removable from the safety needle when the safety needle is in the intermediate position.

13. The fluid control device of claim 10, wherein the sleeve includes a radially inwardly extending portion proximate to a proximal end of the sleeve to slidingly engage the needle hub and for engagement with the needle hub in the intermediate and extended positions.

14. The fluid control device of claim 13, wherein the needle hub includes at least one recess and wherein the radially inwardly extending portion slides into the recess and is retained by the recess in the extended position.

15. The fluid control device of claim 10, wherein the needle hub includes an indicator marking that is covered by the slidable sleeve in the initial and retracted positions and visible in the extended position.

16. The fluid control device of claim 10, wherein the base of the activation device is mounted to the adaptor of the third port.

17. The fluid control device of claim 10, wherein the camming member is attached to a proximal end of the pack.

18. The fluid control device of claim 10, wherein camming engagement of the safety needle with the activation device moves the slidable sleeve into the intermediate position and the flow control member from the first flow control position to the second flow control position

19. The fluid control device of claim 10, wherein the camming surface is a radially-arched groove configured to receive the camming member.

20. The fluid control device of claim 19, wherein the radially-arched groove includes: a first end radially spaced a first distance from a central longitudinal axis of the adaptor; and a second end radially spaced a second distance from the central longitudinal axis of the adaptor, wherein the second distance is smaller than the first distance.

21. The fluid control device of claim 19, wherein the radially-arched groove includes an opening to disengage the camming member from the activation device.

22. The fluid control device of claim 19, wherein the needle includes a needle tip, wherein the needle hub includes a injection end mounted to and partially surrounding the needle and a receiving end mounted to the first port, and wherein the slidable sleeve includes a distal end slidable over the needle and a proximal end mounted on the needle hub so that wherein the needle tip projects from the slidable sleeve in the retracted position, wherein the intermediate position is between the initial position and the retracted position and the slidable sleeve is releasably held in the intermediate position by the needle hub, and wherein injecting the needle into a patient releases the slidable sleeve from the intermediate position toward the retracted position, the slidable sleeve being biased with respect to the needle hub in the retracted position such that upon removal of the needle from the patient the slidable sleeve moves toward the injection end of the needle hub and into the extended position in which the slidable sleeve covers the needle tip.

23. The fluid control device of claim 22, wherein the pack covers the needle tip in the intermediate position and is removable from the base member when the slidable sleeve is in the intermediate position.

24. A fluid control device comprising: a first port; a second port to receive a syringe; a third port that includes an adaptor having a fluid conduit member extending into an interior of a medicinal vessel attached to the adaptor; a flow control member displaceable between first and second flow control positions enabling flow paths between pairs of ports of the first, second, and third ports; and a safety needle connected to the first port that includes: a needle, a hub at least partially surrounding the needle and connected to the first port such that the needle is in fluid communication with the first port, a slidable sleeve mounted on the hub and in direct sliding engagement with the hub in an axial direction, the slidable sleeve having a radially elastically deformable portion, and the hub having a radially converging or diverging portion, wherein the slidable sleeve is slidable in a first axial direction between a first position wherein the needle is at least partially exposed and a second position wherein the needle is further exposed, sliding between the first and second positions causing deformation of the radially elastically deformable portions, and wherein the slidable sleeve is slidable in a second axial direction between the second position and a third position to fully surround the needle, the force to slide the slidable sleeve in the second axial direction being provided by the bias of the radially elastically deformable portions.