Pre-assembled reconstitution and injection device

Abstract

The present invention relates to a pre-assembled reconstitution and injection device, comprising an injection section having a cartridge for holding a diluent or drug product and a reconstitution section having a vial for holding a drug, whereby the injection section may only be disassembled from the reconstitution section after activation of the device has occurred. In an embodiment for use with a pen needle, the reconstitution section comprises a vial needle hub having a reconstitution needle for piercing both the vial and cartridge. In an embodiment of the invention for use with a hypodermic needle, the injection section comprises a cartridge needle hub with a cartridge needle and male luer connection having threads for securing a hypodermic needle, and the reconstitution section comprises a needle hub with a vial needle and a female luer connection for engagement with the male luer connection.

Description

[0001] PRE-ASSEMBLED RECONSTITUTION AND INJECTION DEVICE

[0002] Field of the Invention

[0003] The present invention relates to an injection device, and more specifically to a pre-assembled reconstitution and injection device.

[0004] Background of the Invention

[0005] Most pre-assembled devices are for injection only and use a prefilled syringe or a cartridge. When a drug is not suitable for being in a liquid form (e.g. not stable over time), a user may need to perform a reconstitution using a syringe filled with diluent, add it to a drug vial, wait for the drug to be dissolved and then withdraw the admixture back in the syringe again. Such manipulations could result in misuse and risks such as needle prick injuries, dosage error (e.g. no dose, low dose or overdose), contamination, sterility breach, etc., all of which impact the safety of the end-user and / or the patient.

[0006] There are few pre-assembled injection devices that also permit reconstitution. For example, U.S. patent number 8,915,902 for Inter Vial Transfer System issued December 23, 2014 discloses a pre-assembled cartridge-based reconstitution device in which a cartridge and a vial are pre-assembled inside the device to safely enable diluent and drug to be mixed while minimizing the risk of exposure to needles.

[0007] Dual chamber cartridges also exist in which two chambers are separated by a plunger, and a system allows two substances in the adjacent chambers to be mixed or reconstituted right before administration. See, for example, Canadian Patent Application number 2,116,031 for Dual-Chamber Injection Cartridge. These dual chamber cartridges and associated devices require the specific structure to function and cannot use standard sized vials and cartridges that are widely available and can be filled by many manufacturers.

[0008] What is needed is a pre-assembled device which enables drug reconstitution and injection using readily available vials and cartridges and reduces risks to patient safety such as mis-dosage, needlestick injuries, etc. while supporting the overall user experience. Summary of the Invention

[0009] In an embodiment of the present invention there is a pre-assembled reconstitution and injection device, comprising an injection section having a cartridge for holding a diluent or a drug product and a reconstitution section having a vial for holding a drug. The device can be adjusted from a locked state to an activated state, and the injection section may only be disassembled from the reconstitution section after the device reaches the activated state.

[0010] In a first embodiment of the present invention there is a pre-assembled reconstitution and injection device, comprising an injection section and a reconstitution section, wherein the reconstitution section comprises a housing which houses a vial socket which holds a vial, the vial socket having vial socket tabs. A housing interior comprises vial socket tab unlocking profiled ribs and vial socket tabs activation profiled ribs, whereby the vial socket can rotate in the housing by way of the vial socket tabs moving in the vial socket tab unlocking profiled ribs, and the vial socket can move up the housing by way of the vial socket tabs moving along the vial socket tab activation ribs.

[0011] The reconstitution section of the first embodiment of the present invention further comprises a vial needle hub having a vial needle hub lower body in which a reconstitution needle is fixed and extends both above and below the vial needle hub lower body, and a vial needle hub upper body with vial needle hub arms having vial needle hub tabs, needle hub locking ribs and a rib opening, wherein the vial needle hub lower body fits inside the vial socket. The injection section comprises a cartridge holder which holds the cartridge, the cartridge has a first open end into which fits a cartridge plunger attached to a plunger rod, which plunger rod extends out of the first open end of the cartridge holder, and a second open end of the cartridge holder comprises a needle attachment means.

[0012] The cartridge holder may comprise one or more cartridge holder windows.

[0013] The vial socket may comprise a vial socket body, a vial socket base, vial socket members on the vial socket body having protruding knobs for moving inside L-shaped keyways in the housing, and vial socket arms extending from the vial socket body. The vial socket may also comprise one or more vial socket windows. The reconstitution section may also comprise a spring and a locking sleeve, wherein the locking sleeve comprises locking sleeve body extending from which are locking sleeve latches and locking sleeve backstop ribs, and wherein the spring is between the vial needle hub upper body and the locking sleeve body. The housing interior may also comprise a horizontal rib and upper ribs that lock the locking sleeve in place when the injection section is removed from the reconstitution section as the horizontal rib secures the locking sleeve backstop ribs, preventing the locking sleeve from being ejected from the reconstitution section.

[0014] The cartridge holder may comprise first cartridge holder tabs, and the housing interior, at a top housing body opening, comprises a first cartridge holder keyway for receiving the first cartridge holder tabs. The vial needle hub blocking rib of the vial needle hub blocks the rotation of the first cartridge holder tabs in the first cartridge holder key way.

[0015] The housing interior may further comprise lower recesses and upper recesses for holding the vial needle hub tabs, and the cartridge holder may further comprise cartridge holder latches, and the plunger rod further comprises a first plunger rod rib, a backstop plunger rod rib, and a dosage plunger rod rib, wherein the cartridge holder latches stop the plunger rod from being withdrawn beyond any of the first plunger rod rib, backstop plunger rod rib, and dosage plunger rod rib once any of the plunger rod ribs move past the cartridge holder latches.

[0016] In an embodiment of the present invention, there is a method of adjusting the first embodiment of the pre-assembled reconstitution and injection device from the locked state to the activated state through the steps of: rotating the vial socket base of the vial socket so that the protruding knobs move in the L-shaped key way of the housing as the vial socket tabs rotate in the housing vial socket tab unlocking profiled ribs; pushing the vial socket base against a hard surface so that the vial socket moves up the housing by way of the vial socket tabs moving up the vial socket tab activation profiled ribs and the protruding knobs moving up the L-shapcd keyways, causing the reconstitution needle to pierce the vial; wherein the vial socket arms come up against the ends of the vial needle hub arms, causing the vial needle hub arms to move inward, such that the vial needle hub moves upwards with the vial socket until the vial needle hub tabs move from the lower recesses in the housing to the upper recesses in the housing; the cartridge is pierced by the reconstitution needle when the protruding knobs have moved to the top of the L-shaped keyways and the vial needle hub tabs are in the upper recesses of the housing; the vial needle hub blocking rib moves out of the first cartridge holder keyway to permit the movement of the first cartridge holder tabs in the first cartridge holder keyway; the plunger rod is depressed and the diluent in the cartridge is transferred to the vial containing a drug through the reconstitution needle; the device is swirled to combine the drug and diluent to an admixture; the device is rotated approximately 180 degrees, and the plunger is pulled back to transfer the admixture from the vial to the cartridge through the reconstitution needle; wherein the first cartridge holder tabs are moved out of the first cartridge holder key way permitting the injection section to be removed from the reconstitution section; and wherein the spring pushes the locking sleeve, causing it to move up to the top housing body opening causing the locking sleeve latches to engage with the horizontal rib to prevent the locking sleeve from being ejected from the reconstitution section and blocking the re-attachment of the injection section to the reconstitution section.

[0017] The method of adjusting the first embodiment of the pre-assembled reconstitution and injection device may further include the step of attaching a pen needle assembly to the needle attachment means of the cartridge holder.

[0018] In a second embodiment of the present invention there is a pre-assembled reconstitution and injection device, comprising an injection section and a reconstitution section, wherein the reconstitution section comprises a housing which houses a vial socket which holds a vial, the vial socket having vial socket tabs. A housing interior comprises vial socket tab unlocking profiled ribs and vial socket tabs activation profiled ribs, whereby the vial socket can rotate in the housing by way of the vial socket tabs moving in the vial socket tab unlocking profiled ribs, and the vial socket can move up the housing by way of the vial socket tabs moving along the vial socket tab activation ribs. The injection section also comprises a cartridge needle hub with a threaded interior for hypodermic needle attachment, a cartridge needle, a male luer connection, and cartridge needle hub latches. The reconstitution section also comprises a needle hub with a vial needle and a female luer connection for engagement with the male luer connection.

[0019] In the second embodiment of the present invention, the cartridge holder comprises anti-rotation ribs, a pre-activation groove, and an activation groove, and the cartridge needle hub latches of the cartridge needle hub move from the pre-activation groove when the device is in a locked state to the activation groove when the device is in an activated state

[0020] In a third embodiment of the present invention there is a pre-assembled reconstitution and injection device, comprising an injection section and a reconstitution section, wherein the reconstitution section comprises a housing which houses a vial socket which holds a vial, the vial socket having vial socket tabs. A housing interior comprises vial socket tab unlocking profiled ribs and vial socket tabs activation profiled ribs, whereby the vial socket can rotate in the housing by way of the vial socket tabs moving in the vial socket tab unlocking profiled ribs, and the vial socket can move up the housing by way of the vial socket tabs moving along the vial socket tab activation ribs.

[0021] The third embodiment of the present invention may also comprise an injection section and a reconstitution section, wherein the reconstitution section comprises a housing which houses a vial socket which holds a drug vial and comprises a tamper-proof tab comprising a tab from which sides extend a pair of tab legs ending in tab leg tabs, which tab legs form a U-shape with a tab base between the tab legs and above the tab, and a base of the vial socket rests in the tab base, and on the inside of the housing comprises a pair of tab leg slots, and the vial socket is prevented from fully inserting into the housing by the tab leg tabs resting in the tab leg slots.

[0022] The injection device may also comprise a cartridge holder which holds a cartridge with a first open end into which fits a cartridge plunger attached to a plunger rod, which plunger rod extends out of a first open end of the cartridge holder, and a second open end of the cartridge holder comprises a needle attachment means, and wherein a second end of the cartridge rests in a locking ring body which has a pair of locking ring legs extending out of the second end of the cartridge holder. The housing in addition to and above the pair of tab legs slots comprises a pair of lower vial socket tabs slots, upper vial socket tab slots, lower needle hub tab slots, upper needle hub tab slots, and the vial socket has a pair of vial socket tabs, and the vial needle hub has a pair of vial needle hub tabs. The inside of the cartridge holder comprises a pair of lower locking ring tab slots and upper locking ring tab slots, and the locking ring legs end in locking ring lock tabs. The housing may additionally comprise, on the inside a housing lock tab, and the locking ring body additionally comprises at least one locking ring lock tab, and the cartridge holder additionally comprises a keyway slot, into which the locking ring lock tab fits, and the keyway slot is bisected by a keyway finger on one side, into which the housing lock tab fits, and a key way body on the other side.

[0023] A method of activating the pre-assembled reconstitution and injection device of the third embodiment of the present invention, wherein the locking ring tabs are in the lower locking ring tab slots, vial needle hub tabs are in lower hub tab slots, and vial socket tabs are in lower vial socket tab slots, and wherein the tamper-proof tab is pulled off and the base of the vial socket is depressed on a hard surface which moves the locking ring tabs to the upper locking ring tab slots, vial needle hub tabs to the upper hub tab slots and vial socket tabs to the upper vial socket tab slots and activates the device by connecting any diluent or drug product in the cartridge to any drug in the drug vial, and pushes the locking ring lock tab up in the needle slot, which locks the vial socket and locks the locking ring inside the housing and allows the housing lock tab to be moved from the key way finger to the key way body and release the injection section from the reconstitution section.

[0024] Brief Description of the Figures

[0025] These and other aspects of the present invention will be apparent from the brief description of the drawings and the following detailed description in which:

[0026] Figure la is a front view of a first embodiment of a pre-assembled reconstitution and injection device of the present invention in a first configuration.

[0027] Figure lb is an exploded view of the pre-assembled reconstitution and injection device of Figure la.

[0028] Figure 1c is a further exploded view of the injection section of the pre-assembled reconstitution and injection device of Figure lb.

[0029] Figure Id is a further exploded view of the reconstitution section of the pre-assembled reconstitution and injection device of Figure lb.

[0030] Figure le is an interior view of the housing of Figure la.

[0031] Figure 2a is a side view of the pre-assembled reconstitution and injection device of Figure la.

[0032] Figure 2b is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 2a taken on the line 2b-2b.

[0033] Figure 2c is a close-up view of the pre-assembled reconstitution and injection device of Figure 2b.

[0034] Figure 2d is a cross-sectional view taken on the line 2d-2d of Figure 2a.

[0035] Figure 2e is a top view of Figure 2a. Figure 2f is a cross-sectional view taken on the line 2f-2f of Figure 2e.

[0036] Figure 3a is a front view of the pre-assembled reconstitution and injection device of Figure la in a second configuration.

[0037] Figure 3b is a side view of the pre-assembled reconstitution and injection device of Figure 3a.

[0038] Figure 3c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 3b taken on the line 3c-3c.

[0039] Figure 3d is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 3b taken on the line 3d-3d.

[0040] Figure 3e is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 3b taken on the line 3e-3e.

[0041] Figure 3f is a top view of the pre-assembled reconstitution and injection device of Figure 3a.

[0042] Figure 3g is a sectional view of Figure 3f taken on the line 3g-3g.

[0043] Figure 4a is a front view of the pre-assembled reconstitution and injection device of Figure la in a third configuration.

[0044] Figure 4b is a side view of the pre-assembled reconstitution and injection device of Figure 4a.

[0045] Figure 4c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 4b taken on the line 4c-4c.

[0046] Figure 5a is a front view of the pre-assembled reconstitution and injection device of Figure la in a fourth configuration.

[0047] Figure 5b is a side view of the pre-assembled reconstitution and injection device of Figure 5a.

[0048] Figure 5c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 5b taken on the line 5c-5c.

[0049] Figure 5d is a close-up view of the pre-assembled reconstitution and injection device of Figure 5c. Figure 5e is a top view of the pre-assembled reconstitution and injection device of Figure 5a.

[0050] Figure 5f is a sectional view of Figure 5e taken on the line 5f-5f.

[0051] Figure 5g is a cross-sectional view of Figure 5b taken on the line 5g-5g.

[0052] Figure 6a is a front view of the pre-assembled reconstitution and injection device of Figure la in a fifth configuration.

[0053] Figure 6b is a side view of the pre-assembled reconstitution and injection device of Figure 6a.

[0054] Figure 6c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 6b taken on the line 6c-6c.

[0055] Figure 7a is a front view of the pre-assembled reconstitution and injection device of Figure la in a sixth configuration.

[0056] Figure 7b is a side view of the pre-assembled reconstitution and injection device of Figure 7a.

[0057] Figure 7c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 7b taken on the line 7c-7c.

[0058] Figure 7d is a top view of the pre-assembled reconstitution and injection device of Figure 7a.

[0059] Figure 7e is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 7d taken on the line 7e-7e.

[0060] Figure 8a is a front view of the pre-assembled reconstitution and injection of Figure 7a where the injection section has been removed from the reconstitution section.

[0061] Figure 8b is a side view of Figure 8a.

[0062] Figure 8c is a cross-sectional view of Figure 8a taken on the line 8c-8c.

[0063] Figure 8d is a is a cross-sectional view of Figure 8b taken on the line 8d-8d.

[0064] Figure 9a is an inverted front view of the injection section of Figure 8b with a pen needle assembly. Figure 9b is a side view of Figure 9a.

[0065] Figure 9c is a cross-sectional view of Figure 9b taken on the line 9c-9c.

[0066] Figure 10a is a side view of a second embodiment of a pre-assembled reconstitution and injection device that uses a luer assembly in a first configuration.

[0067] Figure 10b is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 10a taken on the line 10b- 10b.

[0068] Figure 10c is a close-up view of the pre-assembled reconstitution and injection device ofFigure 10b.

[0069] Figure 1 la is an exploded view of the injection section of the pre-assembled reconstitution and injection device that uses a luer assembly ofFigure 10a.

[0070] Figure 1 lb is an exploded view of the reconstitution section of the pre-assembled reconstitution and injection device that uses a luer assembly of Figure 10a.

[0071] Figure 12a is a side view of the pre-assembled reconstitution and injection device that uses a luer assembly ofFigure 10a in a fourth configuration.

[0072] Figure 12b is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 12a taken on the line 12b- 12b.

[0073] Figure 12c is a close-up view of the pre-assembled reconstitution and injection device ofFigure 12b.

[0074] Figure 13a is a front view of the pre-assembled reconstitution and injection device having a luer assembly of Figure 12a where the injection section has been removed from the reconstitution section.

[0075] Figure 13b is a side view of the pre-assembled reconstitution and injection device having a luer assembly ofFigure 13a.

[0076] Figure 14a is an inverted front view of the injection section of Figure 13b with a hypodermic needle assembly. Figure 14b is a side view of the injection section with the hypodermic needle assembly of Figure 14a.

[0077] Figure 14c is a cross-sectional view of the injection section with the hypodermic needle assembly of Figure 14b taken on the line 14c- 14c.

[0078] Figure 15a is a front view of a third embodiment of a pre-assembled reconstitution and injection device of the present invention in a first configuration.

[0079] Figure 15b is an exploded view of the pre-assembled reconstitution and injection device of Figure 15a.

[0080] Figure 15c is a further exploded view of the injection section of the pre-assembled reconstitution and injection device of Figure 15b.

[0081] Figure 15d is a further exploded view of the reconstitution section of the pre-assembled reconstitution and injection device of Figure 15b.

[0082] Figure 16a is a side view of the pre-assembled reconstitution and injection device of Figure 15a.

[0083] Figure 16b is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 16a taken on the line 16b- 16b.

[0084] Figure 16c is a close-up view of the pre-assembled reconstitution and injection device ofFigure 16b.

[0085] Figure 16d is the pre-assembled reconstitution and injection device of Figure 16c without a tamper-proof tab, vial socket, locking ring and vial needle hub.

[0086] Figure 17a is a front view of the pre-assembled reconstitution and injection device of Figure 15a in a second configuration without a tamper-proof tab.

[0087] Figure 17b is a side view of the pre-assembled reconstitution and injection device of Figure 17a. Figure 17c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 17b taken on the line 17c-17c.

[0088] Figure 17d is a horizontal cross-sectional view of the pre-assembled reconstitution and injection device of Figure 17b taken on the line 17d-17d.

[0089] Figure 18a is a front view of the pre-assembled reconstitution and injection device of Figure 15a in a third configuration.

[0090] Figure 18b is a side view of the pre-assembled reconstitution and injection device of Figure 18a.

[0091] Figure 18c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 18b taken on the line 18c- 18c.

[0092] Figure 19a is a front view of the pre-assembled reconstitution and injection device of Figure 15a in a fourth configuration.

[0093] Figure 19b is a side view of the prc-asscmblcd reconstitution and injection device of Figure 19a.

[0094] Figure 19c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 19b taken on the line 19c- 19c.

[0095] Figure 19d is a close-up view of the pre-assembled reconstitution and injection device of Figure 19c.

[0096] Figure 20a is a front view of the pre-assembled reconstitution and injection device of Figure 15a in a fifth configuration.

[0097] Figure 20b is a side view of the pre-assembled reconstitution and injection device of Figure 20a.

[0098] Figure 20c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 20b taken on the line 20c-20c. Figure 21a is a front inverted view of the pre-assembled reconstitution and injection device of Figure 15a in a sixth configuration.

[0099] Figure 21b is a side view of the pre-assembled reconstitution and injection device of Figure 21a.

[0100] Figure 21c is a cross-sectional view of the pre-assembled reconstitution and injection device of Figure 21b taken on the line 21c-21c.

[0101] Figure 22a is a front view of the injection section of the pre-assembled reconstitution and injection device of Figure 21a with a pen needle.

[0102] Figure 22b is a side view of the injection section of the pre-assembled reconstitution and injection device of Figure 22a.

[0103] Figure 22c is a cross-sectional view of the injection section of the pre-assembled reconstitution and injection device of Figure 22b taken on the line 22c-22c.

[0104] Figure 23a is a rotated side view of the pre-assembled reconstitution and injection device of Figure 17a.

[0105] Figure 23b is a close-up view of the locking mechanism of the injection section of the preassembled reconstitution and injection device of Figure 23a.

[0106] Figure 23c is a rotated side view of the pre-assembled reconstitution and injection device of Figure 19a.

[0107] Figure 23d is close-up view of the locking mechanism of the injection section of the preassembled reconstitution and injection device of Figure 23c.

[0108] Figure 23e is a rotated side view of the pre-assembled reconstitution and injection device of Figure 21a during injection section detachment.

[0109] Figure 23f is close-up view of the locking mechanism of the injection section of the preassembled reconstitution and injection device of Figure 23e. Detailed Description of the Invention

[0110] In an embodiment of the present invention shown in Figures 1 to 9, there is a pre-assembled reconstitution and injection device 10 for use with a pen needle assembly 110. For the purposes of describing the present invention, the orientation of top and bottom of the parts of the first pre-assembled reconstitution and injection device 10 in Figures 1 to 6 is the same as the top and bottom of the pages. The Figures 1 to 6, respectively, show the progression of the preassembled reconstitution and injection device 10 from storage or locked position in a first configuration (Figures 1 and 2), to an unlocked position in a second configuration (Figure 3), and then the transition in third configuration (Figure 4) from unlocked (Figure 3) to an activated position in a fourth configuration (Figure 5). Figure 6 shows a fifth configuration in which a diluent is transferred from the cartridge to the vial having an active drug to be mixed together to form an admixture. Figure 7 shows a sixth configuration of the pre-assembled reconstitution and injection device 10 turned approximately 180 degrees in which the admixture is withdrawn back into the cartridge. Figure 8 shows the injection section removed from the reconstitution section 14 of the pre-assembled reconstitution and injection device 10. Figure 9 shows the injection section with a pen needle ready for injection.

[0111] As shown in Figure la, in the first configuration, the first embodiment of the pre-assembled reconstitution and injection device 10 comprises a plunger rod 20, cartridge holder 30, housing 40, a locking sleeve 96 (seen in Figure Id), a spring 210 (seen in Figure Id) and vial socket 50. In Figure lb, for purposes of describing the invention, an injection section 12 is shown separate from a reconstitution section 14 and these respective sections arc shown in exploded view in Figures 1c and Id, respectively. In actual use, when the first pre-assembled reconstitution and injection device 10 is in the first configuration shown in Figures la, 2a and 3a, a user is not able to separate the injection section 12 from the reconstitution section 14.

[0112] As shown in Figures lb and 1c, the injection section 12 is comprised of the cartridge holder 30 (comprising an upper cartridge holder 30a and a lower cartridge holder 30b) holding a cartridge 70 with a cartridge cap 74 and a cartridge plunger 73, and a plunger rod 20. As shown in Figure Id, the reconstitution section 14 is comprised of a vial needle hub 90, a housing 40, a locking sleeve 96, a spring 210, a drug vial 100 and the vial socket 50.

[0113] As shown in Figures la-lc, the plunger rod 20 fits into the open end of the upper cartridge holder 30a and extends into the cartridge 70 to be secured to a cartridge plunger 73. As seen in Figures Ib-lc, in this embodiment the lower cartridge holder 30b comprises a cartridge holder body 34 having two cartridge holder windows 35. There is a pen needle attachment 37 at the bottom end of the lower cartridge holder 30b and first cartridge holder tabs 204 adjacent to the bottom end of the two cartridge holder windows 35. Adjacent the top end of the two cartridge holder windows 35 are second cartridge holder tabs 206. Above the top end of the two cartridge holder windows 35 is a finger flange 32. The pen needle attachment 37 rests in the locking sleeve 96 in the locked state or first configuration of the device.

[0114] Although preferred, it is understood that the invention will function without the cartridge holder windows 35, or with only one cartridge holder windows 35.

[0115] As seen in Figure 1c, the cartridge holder 30 is made up of the upper cartridge holder 30a and the lower cartridge holder 30b. The lower cartridge holder 30b has aligners 200 and the top cartridge holder 30a contains cartridge holder ribs (not shown) that receive the aligners 200 to prevent rotation of the upper cartridge holder 30a relative to the lower cartridge holder 30b. The upper cartridge holder 30a further comprises an opening at a top end (not shown) to receive the plunger rod 20, and the upper cartridge holder 30a has a top finger flange member 333 at a bottom end. In an embodiment of the present invention, the upper cartridge holder 30a further comprises cartridge holder latches 28 for engagement with plunger rod ribs 25a, 25b, 25c on the plunger rod 20 (see Figures 3g and 7e).

[0116] Above the finger flange 32 of the lower cartridge holder 30b is a pair of finger flange ribs 202 that engage the top finger flange member 333 of the upper cartridge holder 30a.

[0117] Although Figure 1c shows an exploded view of the cartridge holder 30, it is understood that the cartridge holder 30 a single inseparable unit.

[0118] The finger flange 32 is adapted to receive the top finger flange member 333 so that the cartridge 70 is located in the cartridge holder 30 and is approximately the same length as the interior of the cartridge holder 30 such that when the plunger rod 20 is depressed, the cartridge cap 74 comes up against the bottom of the cartridge holder 30 forcing the diluent 76 in die cartridge 70 out through a reconstitution needle 92, the top of which pierces the cartridge cap 74.

[0119] The finger flange 32 is useful for injecting with one hand since two fingers may rest on either side of it when the plunger flange 22 is depressed with a thumb. A cartridge holder window 35 permits viewing of the diluent 76 and later the mixture of active drug 106 with diluent 76 (referred to as the admixture 108 shown in Figure 6c); see, for example, Figure lb. As seen in Figure Id, the vial needle hub 90 comprises a vial needle hub upper body 93 with vial needle hub arms 179 having vial needle hub tabs 94 and a vial needle hub lower body 95, with a reconstitution needle 92 fixed within which extends above the vial needle hub upper body 93 and into the vial needle hub lower body 95. The vial needle hub upper body 93 comprises needle hub locking ribs 218 underneath which is a rib opening 219. The vial needle hub lower body 95 fits inside the vial socket 50.

[0120] The vial socket 50 has an open top end and a vial socket base 59 at the bottom end and comprises a vial socket body 52 with a vial socket window 57 in the front and a vial socket window 57 in the back. Although preferred, it is understood that the invention will function without the vial socket windows 57, or with only one vial socket window 57. In a further embodiment of the present invention, neither cartridge holder windows 35 or vial socket windows 57 are needed to see the interior if the cartridge holder 30 and vial socket 50 are transparent or translucent.

[0121] In an embodiment of the invention shown, around the top of the vial socket body 52 there are four vial socket tabs 53. However, it is understood that the invention will also work with two vial socket tabs 53. Referring to Figure Id, between each vial socket window there are protruding knobs 208 which protrude from vial socket members 251 cut out from the vial socket body 52.

[0122] The drug vial 100 comprises a drug vial body 102 within which is an applicable active drug 106 and is covered at the top with a drug vial stopper (not shown) held by a drug vial crimp 104. The drug vial 100 is inserted up past the vial socket base 59 into the vial socket body 52 and is seen through the vial socket windows 57.

[0123] The locking sleeve 96 comprises locking sleeve body 97, extending from which are locking sleeve latches 98 and locking sleeve backstop ribs 99. A spring 210 rests in the vial needle hub upper body 93. The locking sleeve 96, via the locking sleeve body 97, rests on the spring 210. The locking sleeve 96 is pushed towards the bottom of the lower cartridge holder 30b in the locked and unlocked state of the injection device 10 due to the vial needle hub upper body 93 and the small compression of the spring 210 (see Figure 2c). When the injection section 12 is removed from the reconstitution section 14 as seen in Figures 8a, 8b and 8c, the spring 210 pushes the locking sleeve 96 up. The locking sleeve backstop ribs 99 prevent the locking sleeve 96 from being expelled from the device by the spring. The locking sleeve latches 98 engage with a horizontal rib 226 (in the interior of the housing body 42) to lock into place, as seen in Figure 8c. If a user pushes down on the locking sleeve 96, the locking sleeve latches 98 move outwards causing the locking sleeve 96 to be more securely held in place. The extent to which the locking sleeve latches 98 can move outwards is limited by upper ribs 227 (in the interior of the housing body 42). As a result of this functionality, the locking sleeve 96 mechanically makes the device 10 single-use because it blocks a user from reattaching the injection section 12 to the reconstitution section 14.

[0124] The locking sleeve 96 also serves a safety function as the reconstitution needle is below the locking sleeve body 97 and so a user cannot accidentally be poked by the needle as it is never exposed.

[0125] The housing 40 comprises the housing body 42 with a top housing body opening 212 for connection with the injection section 12 and a bottom housing body opening 214 that holds the vial socket 50. Tire housing body 42 comprises two L-shaped keyways 216 along which the protruding knobs 208 travel.

[0126] In an embodiment of the present invention, the plunger rod 20 is not unique and may be the type known and used in the industry with a plunger flange 22 to push the plunger body 24 and a threaded end 26 for attachment to a cartridge plunger 73 in a cartridge 70. Likewise, the cartridge 70 may be the type used in the industry with a cartridge body 72 within which is an applicable diluent 76. Although a diluent 76 is stated to be contained in the cartridge body 72, it is nevertheless understood that the cartridge body 72 could also contain a drug product such as lyophilized drug or a liquid drug.

[0127] In an embodiment of the present invention, plunger rod bumps 246 are added to the top of the plunger rod, underneath the plunger flange 22 to compensate for pressure build up during the transfer of the diluent from the cartridge 70 to the vial 100, and the transfer from the vial 100 back to the cartridge 70 after mixing of the diluent 76 and drug 106 in the vial 100. It is understood that the drug 106 may be either a solid or a liquid.

[0128] As seen in Figures 3g, 5f and 7e, in a further embodiment of the present invention, the plunger rod 20 is unique and also comprises a first plunger rod rib 25a, a backstop plunger rod rib 25b, and a dosage plunger rod rib 25c. The plunger rod ribs 25a, 25b, 25c engage with cartridge holder latches 28 such that when the plunger rod 20 is inserted into the top of the upper cartridge holder 30a the first plunger rod rib 25a engages with the cartridge holder latches 28 to prevent the plunger rod 20 from being removed from the injection section 12 during assembly of the device 10. With further pressure to the plunger rod 20, the backstop plunger rod rib 25b engages the cartridge holder latches to prevent the plunger rod 20 from being removed from the cartridge holder 30 beyond the backstop plunger rod rib’s 25b engagement point with the cartridge holder latches 28. With even further pressure to the plunger rod 20, the dosage plunger rod rib 25c engages the cartridge holder latches 28 to prevent the plunger rod 20 from being removed from the cartridge holder 30 beyond dosage plunger rod rib’s 25c engagement point with the cartridge holder latches 28. This embodiment enables the complete expulsion of the diluent 76 from the cartridge 70 into the vial 100 for mixture with the drug 106. However, it limits a user’s ability to remove the admixture 108 of the drug and diluent beyond the volume permitted to re-enter the cartridge that is determined by the distance up to the dosage plunger rod rib 25c.

[0129] For example, the dosage plunger rod rib 25c may be placed at a location that permits 1 mL of admixture 108 to re-enter the cartridge 70, even if there is more admixture 108 present in the drug vial 100. This allows a manufacturer of the device to pre-set the amount of admixture that a user can access and ultimately inject. This is important in situations where more diluent must be added to the drug in the vial to obtain a desired concentration for use, however, the volume to be injected is less than the volume of the diluent needed to achieve the desired concentration. In an embodiment where the desired concentration of the admixture is achieved through using all of the diluent in the cartridge, the dosage plunger rod rib 25c is not present on the plunger rod 20 as the backstop plunger rod rib 25b is able to act as both a backstop and dosage rib.

[0130] As seen in Figure le, the interior of the housing body 42 comprises vial socket tab unlocking profiled ribs 220 that receive each of the four vial socket tabs 53 and provide a path of travel in one direction only for each of the vial socket tabs, preventing the vial socket tabs from moving in the reverse direction. The interior of the housing body 42 also comprises vial socket tab activation profiled ribs 221 from which the vial socket tabs 53 travel up the length of when moving from a pre-active (unlocked) to active state. The interior of the housing also comprises two lower recesses 222 that hold the vial needle hub tabs 94 in a first configuration in which the device has not yet been activated and two upper recesses 224 that hold the vial needle hub tabs 94 in the fourth, fifth and sixth configurations.

[0131] The interior of the housing body 42 at the top housing body opening 212 comprises a first cartridge holder keyway 228 for receiving the first cartridge holder tabs 204 of the lower cartridge holder 30b, allowing the injection section 12 to be removed from the reconstitution section 14 via the cartridge holder 30 after the device has been activated. Before the device has been activated, the first cartridge holder tabs 204 rest in the first cartridge holder keyway 228 and are prevented from rotating due to the physical interference of the needle hub locking rib 218 of the vial needle hub 90 in a first, locked / storage, state of the device. Once the device is unlocked and activated as the vial needle hub 90 moves up the interior of the housing, the first cartridge holder keyway 228 is no longer blocked by the needle hub locking rib 218, and the first cartridge holder tabs 204 can rotate in a counterclockwise direction only (the shape of the first cartridge holder keyway 228 prevents the clockwise rotation of the first cartridge holder tabs 204) and as such, the injection section can be rotated and removed from the reconstitution section.

[0132] In an embodiment of the present invention there is also a second cartridge holder key way 230 for receiving second cartridge holder tabs 206 of the cartridge holder 30. The second cartridge holder keyway 230 provides additional stability and support for the pre-assembled reconstitution and injection device 10 when activated. Also, after the device 10 is unlocked, the second cartridge holder tabs 206 helps stop the user from inadvertently removing the injection section 12 because of the resistance caused by the second cartridge holder tabs 206.

[0133] Figures 2a to 2f shows the first pre-assembled reconstitution and injection device 10 of Figure la, still in the first / locked configuration.

[0134] In the cross-section views seen in Figures 2b and 2c, the top of the reconstitution needle 92 is adjacent the cartridge cap 74 and the bottom of the reconstitution needle 92 is adjacent the drug vial stopper 105. In this first configuration, the vial socket tabs 53 rest in the vial socket tab unlocking profiled ribs 220 and the vial needle hub tabs 94 rest in the lower recesses 222 of the housing 40. As described above, the injection section 12 cannot be removed from the reconstitution section 14 because the first cartridge holder tabs 204 rest in the first cartridge holder key way 228 and are prevented from rotating due to the physical interference of the needle hub locking rib 218 of the vial needle hub 90.

[0135] The shape of the vial socket tabs 53 only permit the counterclockwise rotation of the vial socket 50 in the vial socket tab unlocking profiled ribs 220 of the housing 40, see Figure 2d.

[0136] Figure 3a to 3g shows the pre-assembled reconstitution and injection device 10 in a second configuration in which the device 10 is unlocked by rotating the vial socket base 59 such that the protruding knobs 208 move in the L-shaped keyways 216 of the housing 40 so that the protruding knobs 208 are now in a position that allows for the vial socket 50 to be moved up along the path of the L-shaped key ways 216. Figure 3e shows that in this first configuration of the device, the first cartridge holder tabs 204 are still prevented from rotating due to the needle hub locking rib 218 of the vial needle hub 90.

[0137] Chronologically, Figures 4a to 4c show that the upward movement of the vial socket 50 causes the vial needle hub 90 to be pushed up so that the bottom of the reconstitution needle 92 pierces the drug vial stopper 105 of the drug vial 100. In this third configuration, the protruding knob 208 of the vial socket 50 move up the L-shaped keyway 216 of the housing (see Figure 4b). At the same time, as seen in Figures 3g to 4c to 5f, the vial socket tabs 53 move up the vial socket tab activation profiledribs 221 of the housing 40, and the ends of the vial socket arms 55 come up against the ends of the vial needle hub arms 179, moving the vial needle hub arms 179 inwards, causing the vial needle hub 90 to similarly move upwards until the vial needle hub tabs 94 move from the lower recesses 222 in the housing 40 to the upper recesses 224 in the housing 40.

[0138] As shown in Figures 5a to 5d, in the fourth configuration, this causes the top of the reconstitution needle 92 to pierce the cartridge cap 74 of the cartridge 70. For the purposes of illustrating what occurs, Figures 4a to 4c and Figures 5a to 5f are described as a third and a fourth configuration, respectively. However, this sequential fluid path opening occurs in one fluid motion, and the third configuration is a transitional state of the activation after piercing the drug vial 100 used for the purpose of describing the present invention. When the vial socket base 59 of the first pre-assembled reconstitution and injection device 10 as shown in Figures 3a to 3c is firmly depressed on a hard surface, the vial socket 50 is pushed up until the vial socket base 59 is flush against the bottom of the housing body 42 as shown in Figures 5a to 5c.

[0139] It is important that the drug vial 100 is pierced before the cartridge 70 is pierced to prevent loss of diluent 76 from the cartridge 70 should it be pierced first. This is not a concern when piercing the drug vial 100 as the drug 106 is in a solid form.

[0140] As seen in Figures 3c to 4c to 5d, the vial socket tabs 53 are moving up from being in vial socket tab unlocking profiled ribs 220 in Figure 3c, in transition in Figure 4c and in Figure 5f the vial socket tabs 53 moves up the vial socket tab activation profiled ribs 221 and fit into upper vial socket tab slots 47 inside the housing 40. Likewise, the vial needle hub tabs 94 move from lower recesses 222, up and into upper recesses 224 inside the housing 40. As seen in Figure 5c, the reconstitution section 14 can’t be disassembled since there is nothing to grip or pull on at the top of the housing body 42 and pulling down on the vial socket base 59 will, if any movement is even possible, cause the vial socket members 251 to move inward and hold tighter onto the vial 100. This means that the drug vial 100 can’t be accessed or used again and the reconstitution needle 92 can’t be accessed or used again.

[0141] As shown in Figures 6a to 6c, to transfer the diluent into the drug vial 100, the plunger flange 22 has been pushed down so the plunger rod 20 pushes the cartridge plunger 73, which pushes the diluent into the drug vial 100. The user may then swirl or shake the first pre-assembled reconstitution and injection device 10 to fully dissolve the active drug in the diluent to form an admixture 108.

[0142] As shown in Figures 7a to 7e, the first pre-assembled reconstitution and injection device 10 is inverted upside down by about 180 degrees and the plunger rod 20 is retracted from a fully depressed position in the cartridge by pulling the plunger flange 22 to draw the admixture 108 back into the cartridge 70. In an embodiment of the invention with plunger ribs 25a, 25b, 25c (shown in Figure 7e) the amount to which the plunger rod 20 is retracted is determined by the placement of the dosage rib 25c. The user can see when the drug vial 100 is empty (or the proper dosage has been removed) through the vial socket windows 57 and can see the admixture 108 in the cartridge 70. The device 10 is again inverted by about 180° before the injection section 12 is detached from the reconstitution section 14, as shown in Figure 8a. By holding the housing 40 and clockwise turning of the cartridge holder body 34, the injection section 12 may now be detached from the reconstitution section 14.

[0143] The function of the locking sleeve 96 is illustrated in Figures 8a to 8d. When the injection section 12 is removed from the reconstitution section 14, the locking sleeve 96 is pushed upwards by the spring 210 causing the horizontal rib 226 of the housing 40 to lock the locking sleeve 96 in place. The upper ribs 227 act to further limit the locking sleeve latches 98 from extending too far outward when the injection section 12 is removed from the reconstitution section 14. Also, if a user presses down on the locking sleeve 96, the locking sleeve latches 98 splay outward preventing the movement of the locking sleeve 96. This also prevents the reuse of the reconstitution section as the locking sleeve 96 physically blocks the ability of an injection section from being re-connected to the existing reconstitution section once it has been disconnected, and so the locking sleeve 96 makes the device 10 mechanically a single-use device. The locking sleeve 96 prevents access to the reconstitution needle 92 preventing a user from being pricked as the reconstitution needle 92 is lower than the locking sleeve 96, and thus there is no opportunity for a user to inadvertently get pricked with the needle.

[0144] As shown in Figures 9a to 9c, a pen needle assembly 110 comprising a pen needle 112 with pen needle cap 111 is screwed onto the pen needle attachment 37 on the cartridge holder 30. The cartridge holder 30 and plunger rod 20 with pen needle 112 may now be used just like a regular syringe to deliver the admixture 108 through injection by the user or a medical professional.

[0145] In operation, a user receives a pre-assembled reconstitution and injection device 10 of the present invention in its first configuration that is locked as shown in Figures la, 2a to 2f. A user twists the vial socket base 59 of the vial socket 50 so that the protruding knobs 208 of the vial socket 50 move in the bottom of the L-shaped key ways 216 of the housing 40. This is the second / unlocked configuration seen in Figures 3a to 3f. As is seen in Figure 3d, the vial socket tabs 53 rotate in the housing vial socket tab unlocking profiled ribs 220 of the housing 40, and as seen in Figure 3e, the cartridge holder tabs 204 of the cartridge holder 30 are prevented from rotating because they are blocked by the needle hub locking rib 218 of the vial needle hub 90.

[0146] The user then pushes the vial socket base 59 against a hard surface, forcing the vial socket 50 to move up the housing, seen in Figures 4a to 4c. In this third configuration the protruding knobs 208 move up the L-shaped keyways 216 and the vial socket tabs 53 move up the vial socket tab activation profiled ribs 221. The reconstitution needle 92 pierces the drug vial stopper 105. The ends of the vial socket arms 55 come up against the ends of the vial needle hub arms 179, causing the vial needle hub arms 179 to move inward, and the vial needle hub 90 to similarly move upwards until the vial needle hub tabs 94 move from the lower recesses 222 in the housing 40 to the upper recesses 224 in the housing 40. When the protruding knobs 208 are at the top of the L-shaped keyways 216 and the vial needle hub tabs 94 are in the upper recesses 224, the device is now in the fourth, fully activated, configuration as seen in Figures 5a to 5e. In the fourth configuration, the reconstitution needle 92 pierces the cartridge cap 74, and the first cartridge holder tabs 204 can now rotate in the first cartridge holder keyway 228 as die needle hub locking rib 218 has been moved up the housing and the rotational path of the first cartridge holder tabs 204 is no longer blocked.

[0147] In the fifth configuration, shown in Figures 6a to 6c, the plunger flange 22 is depressed so that the diluent in the cartridge 70 is expelled from the cartridge, travels through the reconstitution needle 92 and enters the vial 100. The device is then gently swirled or shaken so that the drug in the vial is reconstituted in the diluent to form an admixture 108 so that it may be injected into a subject. As shown in Figures 7a to 7e, the device 10 is then flipped upside down so that the admixture 108 of the diluent and the drug are at the bottom of the vial 100 and the plunger rod 20 is pulled back from the device, allowing the admixture 108 to travel through the reconstitution needle 92 and back into the cartridge 70. In an embodiment of the invention, the plunger rod 20 is retracted up to the dosage plunger rod rib 25c, or the backstop plunger rod rib 25b if the dosage plunger rod rib 25c is not present.

[0148] The injection section 12 is then rotated so that it can be removed from the reconstitution section 14, as seen in Figures 8a to 8d. When the injection section 12 is removed from the reconstitution section 14, the spring 210 pushes the locking sleeve 96 up to the top housing body opening 212. This causes the horizontal rib 226 of the housing 40 to lock the locking sleeve 96 in place as the locking sleeve backstop ribs 98 engage with the horizontal rib 226 such that the locking sleeve 96 cannot be pulled up and out of the top housing body opening 212. The upper ribs 227 act to further limit the locking sleeve latches 98 from extending too far outward when the injection section 12 is removed from the reconstitution section 14.

[0149] Once the injection section 12 has been removed from the reconstitution section 14, a pen needle assembly 110 can be screwed on to the pen needle attachment 37 of the cartridge holder 30, as seen in Figures 9a to 9c, and the device 10, having the reconstituted diluent / drug mixture in the cartridge, is ready to be used on a subject.

[0150] In the present invention, the plunger rod 20 is not used to lock the device, and the injection section 12 is used after a needle is screwed as shown in Figures 9a to 9c. The injection section 12 looks like a syringe even though there is a cartridge 70 in it, and aids in the user taking the next step of securing a pen needle assembly 110.

[0151] As described above, the first pre-assembled reconstitution and injection device 10 is single-use and mechanically not reusable, does not expose any needles other than the pen needle 112 which must be used for injections.

[0152] The first pre-assembled reconstitution and injection device 10 is pre-assembled so that a user doesn’t need to assemble the device, which avoids mistakes. The user also cannot accidentally mix the wrong diluent and drug since they can’t remove the cartridge or vial which are preinstalled when the device 10 is manufactured. The structure of the pre-assembled reconstitution and injection device 10 of the present invention requires sequential activation of the device as each step / configuration of the device must take place before the next step can happen. This means that the device must first be unlocked, then activated, the transfer of the diluent from the cartridge to the vial takes place next, followed by the mixture of the drug and diluent, the drug / diluent is then transferred back to the cartridge. The injection section 12 with the cartridge can then be removed, at which point the locking sleeve 96 acts to secure the reconstitution section 14 so that it can no longer be used. This is a stroke driven sequence in which each movement, or stroke, of the device must take place before the next step can be taken.

[0153] The structure of the pre-assembled reconstitution and injection device 10 of the present invention also provides tactile and audible feedback to a user each time a step in the sequence takes place. This occurs due to the movement of the vial socket tabs 53 when they are rotated in the vial socket tab unlocking profiled ribs 220, causing audible and tactile feedback when the device is unlocked. The movement of the vial socket tab 53 up the vial socket tab activation profiled ribs 221 also cause audible and tactile feedback as the device becomes activated. Finally, the movement of the vial needle hub latches 94 from the lower recesses 222 to the upper recesses 224 provides further audible and tactile feedback to indicate to a user that both the cartridge cap 73 and the vial stopper 105 have been pierced by the reconstitution needle 92 and so the transfer of the diluent from the cartridge to the vial can now take place by depressing the plunger rod 20.

[0154] This audible and tactile feedback is also accompanied by visual feedback for the user due to the cartridge holder windows 35 and the vial socket windows 57, which visually show a user where the drug and diluent are at any time in the sequential activation of the device. Visual feedback of the device 10, particularly before the steps of activation and reconstitution, includes the movement of the protruding knobs 208 in the L-shaped keyways 216, indicating to the end user where they are in the reconstitution process, be it locked (the protruding knobs 208 in the lower portion of the L-shaped keyways 216, blocked from moving upward), unlocked (the protruding knobs 208 in the lower portion of the L-shaped key ways 216, able to move upward) or fully activated (the protruding knobs 208 in the upper portion of the L-shaped key ways 216).

[0155] The drug vial 100 is installed when the first pre-assembled reconstitution and injection device 10 is manufactured, not by a user. In assembling, the drug vial 100 is pushed down into the vial socket 50. Separately, the vial needle hub 90 is inserted into the bottom of the housing 40. Separately, the plunger rod 20 is inserted into the cartridge holder 30 and then the plunger threaded end 26 of the plunger rod 20 is screwed into a cartridge plunger 73 in the cartridge 70. The spring 210 is inserted around the reconstitution needle 92 extending up from the vial needle hub upper body 93 and the locking sleeve 96 is placed above the spring 210. The pen needle attachment 37 of the cartridge holder 30 rests in the locking sleeve 96. The housing 40, made up of two identical components (see one half in Figure le) is secured around the inner mechanisms so that the device is in its first configuration. The first pre-assembled reconstitution and injection device 10 is configured as described above which avoids piercing the drug vial 100 and cartridge 70 during shipping.

[0156] As most of the mechanisms of the prc-asscmblcd reconstitution and injection device 10 of the present invention are located in the housing, when the injection section 12 is removed from the reconstitution section 14, there are minimal features for the end user to see.

[0157] Because it is pre- assembled, the first pre- assembled reconstitution and injection device 10 is placed into packaging, e.g. a pouch or tray, and is then sterilized via a gas process (CD, ETO or NO2). The user may open the sterile barrier package before usage. The fact that the sterilization process must be performed after assembly means that all surfaces must be accessible by gas and the inside of the needle and fluid device path must be sterilized.

[0158] In a second embodiment of the present invention, a luer assembly is used in place of a pen needle assembly to attach a hypodermic needle to the injection section after reconstitution has taken place. This second embodiment can be seen in Figures 10 to 14. In this embodiment, rather than a vial needle hub having a double-ended reconstitution needle 92 to pierce both the vial and the cartridge there are instead two separate needles, a cartridge needle 340 (seen in Figure 10c) to pierce the cartridge 70 and a vial needle 320 to pierce the vial 100.

[0159] As seen in Figure 1 la, an end of the cartridge holder 30 has anti-rotation ribs 360, a preactivation groove 370, and an activation groove 380. In the luer assembly, there is also a cartridge needle hub 330 that comprises a male luer connection 332, cartridge needle 340 (not shown) extending towards the cartridge, a threaded interior (not shown in Figures Ila or 1 lb) and cartridge needle hub latches 336. In the embodiment shown in Figure I la, there arc 4 cartridge needle hub latches 336, however, it is understood that there may be more or less cartridge needle hub latches 336. The cartridge needle hub 330 fits on an end of the cartridge housing 30 by way of the cartridge needle hub latches 336 engaging with the pre-activation groove 370 when the device is in a storage or locked state, and the cartridge needle hub latches 336 move up to the activation groove 380 when the device has been activated.

[0160] In this second or luer embodiment instead of a reconstitution needle that extends both towards the cartridge and the vial, there is only one vial needle 320 that extends towards the vial 102; see Figure 11b. The needle hub 310 also comprises a female luer connection 350 that extends from the vial needle hub lower body 95 towards the male luer connection 332 of the cartridge needle hub 330. The female luer connection 350 can be seen in Figures 10b, 10c, 12b and 12c.

[0161] In the luer embodiment of the invention, a separate cartridge needle 340 and vial needle 320 is needed because when the injection section 12 is removed from the reconstitution section 14, a different needle is needed to pierce the cartridge cap 74 because a hypodermic needle 370 only has one needle for inj ecting into a subj ect and has no needle to pierce the cartridge cap, whereas a pen needle is double ended so that one end can pierce the cartridge, and the other end can be injected into a subject.

[0162] In a typical hypodermic needle that would be used with a luer assembly, there is a single-ended needle that is used to inject a subject, and so what is needed with the luer embodiment of the present invention is a second needle to pierce the cartridge so that the reconstituted admixture 108 can flow out of the cartridge 70 and then through the hypodermic injection needle 370 for injection into a subject.

[0163] In this luer embodiment of the present invention, the reconstitution needle has been separated into two needles because one needle must stay back in the cartridge so that the reconstituted admixture 108 can be injected into a subject when a hypodermic needle is attached to the luer. Separating the reconstitution needle in the luer embodiment of the present invention means that there is no exposure to a needle when the injection section 12 is removed from the reconstitution section 14. As such, a spring or locking sleeve is not required for the luer embodiment of the present invention to work. However, it is still desirable to include a spring and locking sleeve in the luer embodiment of the present invention (not shown in Figures 10- 14) to prevent rc-usc of the device.

[0164] The activation steps for this luer assembly embodiment are the same as the pen needle assembly embodiment. Figures 10a to 10c show the device in a locked / storage state. In the locked / storage state, there is a gap between the threaded male luer connection 330 and the female luer connection 350 so that sterilization gas can move between all parts of the device. When the device is activated the vial needle 320 pierces the vial stopper 105. Figure 12a to 12c shows the luer embodiment of the present invention in an activated state, where the vial socket 50, needle hub 310, and cartridge needle hub 330 have moved up the housing 40 such that a leak- free seal between the threaded male luer connection 330 and female luer connection 350 has been formed, and such that the cartridge needle 340 has pierced the cartridge cap 74, creating a leak-tight fluid pathway between the cartridge 70 and the vial 100 via the vial needle 320 and cartridge needle 340. The diluent 76 in the cartridge is then ejected from the cartridge 70 by pressing down on the plunger rod 20 and moves to the vial 100 where it is mixed with the active drug 106 by gently swirling the device 10. The device 10 is then turned upside down so that the reconstituted admixture 108 can be returned to the cartridge 70 by pulling back the plunger rod 20. At this point the injection section 12 is removed from the reconstitution section 14, as shown in Figures 13a and 13b.

[0165] As seen in Figures 14a, 14b, and 14c, once the injection section 12 has been removed from the reconstitution section, the injection / hypodermic needle assembly 360 can be secured to the cartridge needle hub 330 by way of screwing the hypodermic needle 370 on the cartridge needle hub threads 334 (shown in Figure Ila). In an embodiment of the present invention, the hypodermic needle assembly 360 comprises a hypodermic needle 370 and a hypodermic needle cap 380 to avoid a user being pocked with the needle 370. The needle cap 380 is removed before the injection of the reconstituted diluted / active drug mixture.

[0166] In a third embodiment of the present invention shown in Figures 15 to 23, there is a preassembled reconstitution and injection device 10 for use with a pen needle assembly 110. For the purposes of describing this third embodiment of the present invention, the orientation of top and bottom of the parts of the pre-assembled reconstitution and injection device 10 in Figures 15 to 20 is the same as the top and bottom of the pages. The Figures 15 to 19, respectively show the progression of the pre-assembled reconstitution and injection device 10 from resting, in a first configuration, to ready to use or unlocked, in a second configuration, and then activation in a third to a fourth configuration. Figure 20 shows a fifth configuration in which a diluent is transferred from the cartridge to the vial having an active drug to be mixed together to form an admixture. Figure 21 shows a sixth configuration of the pre-assembled reconstitution and inj ection device 10 turned 180 degrees in which the admixture is withdrawn back into the cartridge. Figure 22 shows the injection section with a pen needle. Figure 23 shows how the injection section of Figure 22 is released from the pre-assembled reconstitution and injection device of Figures 18 to 21.

[0167] As shown in Figure 15a, in the first configuration, the embodiment of the pre-assembled reconstitution and injection device 10 comprises a plunger rod 20, cartridge holder 30, housing 40, vial socket 50 and a tamper-proof tab 60. As shown in Figure 15b, for purposes of describing the invention, an injection section 12 is shown at the top of Figure 15b separate from a reconstitution section 14 and these respective sections are shown in exploded view in Figures 15c and 15d, respectively. In actual use, when the pre-assembled reconstitution and injection device 10 is in the first configuration shown in Figures 15a, 16a and 17a, a user is not able to separate the injection section 12 from the reconstitution section 14.

[0168] As shown in Figures 15b and 15c, the injection section 12 is comprised of the cartridge holder 30 holding a cartridge 70 with a cartridge cap, a plunger rod 20, and holding a locking ring 80. As shown in Figure 15d, the reconstitution section 14 is comprised of a vial needle hub 90, the housing 40, a drug vial 100, the vial socket 50 and the tamper-proof tab 60.

[0169] As shown in Figures 15a-15d, the plunger rod 20 fits into the open end of the cartridge 70 while the other end of the cartridge 70 having a cartridge cap 74 fits into a locking ring 80 which rests inside the cartridge holder 30 such that a locking ring legs 84 are on either side of a pen needle attachment 37 of the cartridge holder 30 and only part of the plunger rod 20 is seen coming out of a finger flange neck 31 of the cartridge holder 30.

[0170] The plunger rod 20 is not unique and may be the type known and used in the industry with a plunger flange 22 to push the plunger body 24 and a threaded end 26 for attachment to a cartridge plunger 73 in a cartridge 70. Likewise, the cartridge 70 may be the type used in the industry with a cartridge body 72 within which is an applicable diluent 76. Although a diluent 76 is stated to be contained in the cartridge body 72, it is nevertheless understood that the cartridge body 72 could also contain a drug product such as a lyophilized drug or a liquid drug.

[0171] The locking ring 80 has an upper U-shaped locking ring body 82 comprising a locking ring cartridge channel 85 and extending below are a pair of locking ring legs 84. The cartridge cap 74 and part of the cartridge 70 fit into the locking ring cartridge channel 85 and the pen needle attachment 37 rests between the locking ring legs 84. The locking ring body 82 has a locking ring tab 81 on each side at the opening of the locking ring cartridge channel 85 and has a locking ring lock tab 83 at each side above each of the locking ring legs 84. In this third embodiment the cartridge holder 30 comprises a finger flange body 33 above a cartridge holder body 34 but it will be understood that this could be of the same diameter. The finger flange 32 is useful for injecting with one hand since two fingers may rest on either side of it when the plunger flange 22 is depressed with a thumb. A cartridge holder window 35 permits viewing of the diluent 76 and later the mixture of active drug 106 with diluent 76, forming an admixture 108.

[0172] The vial needle hub 90 comprises a vial needle hub upper body 93 with vial needle hub tabs 94 and a vial needle hub lower body 95, with a reconstitution needle 92 fixed within which extends above the vial needle hub upper body 93 and into the vial needle hub lower body 95. The vial needle hub lower body 95 fits inside the vial socket 50. The vial socket 50 has an open top end and a vial socket base 59 at the bottom end and comprises a vial socket body 52 with a vial socket window 57 in the front and a vial socket window 57 in the back. Although preferred, it is understood that the invention will function without the vial socket windows 57, or with only one vial socket window 57.

[0173] On each side of the vial socket body 52 there is a vial socket tab 53 each of which is above vial socket tab openings 54 shown in Figure 17b. Referring to Figure 15d, a pair of vial socket guides 51 bracket each vial socket tab 53 and extend down below each vial socket window 57. The drug vial 100 comprises a drug vial body 102 within which is an applicable active drug 106 and is covered at the top with a drug vial stopper 105 held by a drug vial crimp 104. The drug vial 100 is inserted up past the vial socket base 59 into the vial socket body 52 and is seen through the vial socket windows 57. It is understood that the drug 106 may be either a solid or a liquid.

[0174] The tamper-proof tab 60 comprises a pair of tab legs 61 rising on each side from a tab base 66 under which is a tab pull 68. At the top of each tab leg 61 is a tab leg tab 62 above a tab leg groove 63. The tab leg tabs 62 fit into a tab leg slot 45 (shown in Figures 16c and 16d) inside the bottom of the housing body 42. On either side of the housing window 44 are interior angled grooves (not shown) into which the vial socket guides 51 fit such that the bottom of the housing body 42 covers them in the first configuration.

[0175] Figures 16a to 16c shows the pre-assembled reconstitution and injection device 10 of Figure 15a, still in the first configuration. Figure 16d shows the pre-assembled reconstitution and injection device 10 without the vial socket 50, locking ring 80 and vial needle hub 90 to show the slots in housing body 42 and cartridge holder body 34, namely lower locking ring tab slots 86 and upper locking ring tab slots 87, and the slots in the housing 40, namely tab leg slot 45, lower vial socket tab slot 46, upper vial socket tab slot 47, lower needle hub tab slot 41 and upper needle hub tab slot 43.

[0176] The tamper-proof tab 60 may be tapped on a hard surface but the pre-assembled reconstitution and injection device 10 shown in Figures 15 and 16 remains in first configuration. Pushing down on the tamper-proof tab 60 causes the tab legs 61 to move outwardly pushing the tab leg tabs 62 further into the tab leg tab slots 45 (shown in Figures 16b and 16c) and locking further.

[0177] By pulling down on the tab pull 68, the pair of tab leg tabs 62 slip out of the tab leg tab slots 45 and the tamper-proof tab 60 is removed. Figures 17a to 17c show the pre-assembled reconstitution and injection device 10 without the tamper-proof tab 60 and in cross-section.

[0178] In the cross-section views seen in Figures 16b and 16c and Figure 17c, the top of the reconstitution needle 92 is adjacent the cartridge cap 74 and the bottom of the reconstitution needle 92 is adjacent the drug vial stopper 105.

[0179] After the tamper-proof tab 60 is removed, the pre-assembled reconstitution and injection device 10 is in a second configuration as shown in Figures 17a to 17c.

[0180] Chronologically, Figures 18a to 18c show that the upward movement of the vial socket 50 causes the vial needle hub 90 to be pushed up so that the bottom of the reconstitution needle 92 pierces the drug vial stopper 105 of the drug vial 100, and next, as shown in Figures 19a to 19d, the top of the reconstitution needle 92 pierces the cartridge cap 74 of the cartridge 70. For the purposes of illustrating what occurs, Figures 18a to 18c and Figures 19a to 19d are described as a third and a fourth configuration, respectively. However, this sequential fluid path opening occurs in one fluid motion, and the third configuration is a transitional state of the activation after piercing the drug vial 100 used for the purpose of describing the present invention. When the vial socket base 59 of the pre-assembled reconstitution and injection device 10 as shown in Figures 17a to 17c is firmly depressed on a hard surface, the vial socket 50 is pushed up until the vial socket base 59 is flush against the bottom of the housing body 42 as shown in Figures 19a to 19c.

[0181] As seen in Figures 17c to 18c to 19d, the vial socket tabs 53 are moving up from being in lower vial socket tab slot 46 in Figure 17c, in transition in F igure 18c and in F igure 19d the vial socket tabs 53 fit into upper vial socket tab slots 47 inside the housing 40. Likewise, the vial needle hub labs 94 move from lower hub tab slots 41, up and into upper hub tab slots 43 inside the housing 40. As seen in Figure 19d, the reconstitution section 14 can’t be disassembled since there is nothing to grip or pull on at the top of the housing body 42 and pulling down on the vial socket base 59 will, if any movement is even possible, only cause the vial socket tabs 53 to bend outward and lock even more firmly into the upper vial socket tab slots 47. This means that the drug vial 100 can’t be accessed or used again and the reconstitution needle 92 can’t be accessed or used again.

[0182] The locking ring 80 locks the injection section 12 in the reconstitution section until the preassembled reconstitution and injection device 10 is activated.

[0183] When looking from Figure 17c to 18c to 19d the locking ring tabs 81 are pushed up out of lower locking ring tab slots 86 until they fit into upper locking ring tab slots 87 inside the cartridge holder 30. This also prevents the locking ring legs 84 from being accessible and they remain up in the cartridge holder body 34 since locking ring 80 is locked in place by the locking ring tabs 81 remaining in the upper locking ring tab slots 87.

[0184] As shown in Figures 20a to 20c, to transfer the diluent 76 into the drug vial 100, the plunger flange 22 is pushed down and the plunger rod 20 pushes the cartridge plunger 73, which pushes the diluent into the drug vial 100. The user may then swirl or shake the pre-assembled reconstitution and injection device 10 to fully dissolve the active drug 106 in the diluent 76.

[0185] As shown in Figures 21a to 21c, the pre-assembled reconstitution and injection device 10 is flipped upside down and the plunger rod 20 is pulled out by pulling the plunger flange 22 down to draw the diluent 76 with the dissolved active drug 106 back into the cartridge 70. The user can see when the drug vial 100 is empty through the vial socket windows 57 and can see the diluent 76 with the dissolved active drug 106 in the cartridge 70. By holding the housing 40 and clockwise turning of the cartridge holder body 34, the injection section 12 may now be detached from the reconstitution section 14.

[0186] As shown in Figures 22a to 22c, a pen needle assembly 110 comprising a pen needle 112 with pen needle cap 111 is screwed onto the pen needle attachment 37 on the cartridge holder 30. The cartridge holder 30 and plunger rod 20 with pen needle 112 may now be used just like a regular syringe to deliver the dissolved active drug 106 in diluent 76 through injection by the user or a medical professional.

[0187] As shown in Figures 23a to 23f, the injection section 12 cannot be unscrewed before the preassembled reconstitution and injection device 10 is in the fourth configuration. The reconstitution section in Figures 23a, 23c, and 23e is cut away to show the locking mechanism of the keyway slot 39, housing lock tab 83, and keyway finger 38. As shown in Figures 23a and 23b, in the first configuration before activation, the locking ring lock tab 83 is in the lower part of the keyway slot 39 which locks the housing lock tab 83 in the keyway finger 38 and prevents the injection section 12 from being unscrewed.

[0188] When the pre-assembled reconstitution and injection device 10 is moving from the first configuration to the third configuration and fourth configuration, the locking ring legs 84 are pushed up by the vial needle hub 90, as seen in Figure 19d, which moves the locking ring tabs 81 from lower locking ring tab slots 86 to upper locking ring tab slots 87. As seen in Figures 23c to 23f, this allows the housing lock tab 48 to move from the key way finger 38 and into the key way body 36. This permits the injection section 12 to be pulled out of the housing 40.

[0189] As shown in Figures 15 to 16, the pre-assembled reconstitution and injection device 10 in a first configuration will not work and cannot be depressed to activate without removing the tamper-proof tab 60 as is shown in the second configuration in Figures 17. Before activation of the pre-assembled reconstitution and injection device 10, locking ring tabs 81 are in lower locking ring tab slots 86, vial needle hub tabs 94 are in lower hub tab slots 41, and vial socket tabs 53 are in lower vial socket tab slots 46. Removing the tamper-proof tab 60 and depressing the pre-assembled reconstitution and injection device 10 shown in Figures 17 on a hard surface activates the device by connecting the cartridge 70 with the drug vial 100 and unlocking the locking ring lock tab 83 as shown in Figures 18 to 21, so that the injection section 12 may be unscrewed and independent from the reconstitution section as shown in Figures 22. As shown in Figures 21, after activation of the pre-assembled reconstitution and injection device 10, locking ring tabs 81 are in upper locking ring tab slots 87, vial needle hub tabs 94 are in upper hub tab slots 43 and vial socket tabs 53 are in upper vial socket tab slots 47. This activation locks the vial socket 50 and locks the locking ring 80 inside the housing 40.

[0190] In this third embodiment of the present invention, the plunger rod 20 is not used to lock the device, and the injection section 12 is used after a needle is screwed on, as shown in Figures 22. The injection section 12 looks like a syringe even though there is a cartridge 70 in it, and aids in the user taking the next step of securing a pen needle assembly 110.

[0191] As described above, the third embodiment of the pre-assembled reconstitution and injection device 10 is single use and mechanically not reusable, does not expose any needles other than the pen needle 112 which must be used for injections. The third embodiment of the pre-assembled reconstitution and injection device 10 is preassembled so that a user doesn’t need to assemble the device, which avoids mistakes. The user also cannot accidently mix the wrong diluent and drug since they can’t remove the cartridge or vial which are pre-installed when the device 10 is manufactured. The pre-assembled reconstitution and injection device 10 can’t be depressed without removing the tamper-proof tab 60, which is a further safety feature.

[0192] The drug vial 100 is installed when the third embodiment of the pre-assembled reconstitution and injection device 10 is manufactured, not by a user. In assembling, the drug vial 100 is pushed up into the vial socket 50 and then the vial socket 50 is pushed down onto the tab legs 61 of the tamper-proof tab 60. Separately, the vial needle hub 90 is inserted into the bottom of the housing 40. Separately, the plunger rod 20 is inserted into the finger flange neck 31 of the finger flange body 33 and then the plunger threaded end 26 of the plunger rod 20 is screwed into a cartridge plunger 73 in the cartridge 70. The locking ring 80 is inserted in the cartridge holder body 34 and into the top of the housing 40. The cartridge 70 is inserted into the locking ring cartridge channel 85 and pushed down. The bottom of the housing 40 is then pushed down onto the vial socket 50, which has the drug vial 100 and tamper-proof tab 60 installed as described above. The pre-assembled reconstitution and injection device 10 is configured as described above which avoids piercing the drug vial 100 and cartridge 70 during shipping.

[0193] Because it is pre-assembled, the third embodiment of pre-assembled reconstitution and injection device 10 is placed into packaging, e.g. a pouch or tray, and is then sterilized via a gas process (CD, ETO or NO2). The user may open the sterile barrier package before usage. The fact that the sterilization process must be performed after assembly means that all surfaces must be accessible by gas and the inside of the needle and fluid device path must be sterilized.

[0194] While embodiments of the invention have been described in the detailed description, the scope of the claims should not be limited by the preferred embodiments set forth in the examples but should be given the broadest interpretation consistent with the description as a whole.

Claims

CLAIMSWhat is claimed is:

1. A pre-assembled reconstitution and injection device, comprising an injection section having a cartridge for holding a diluent or a drug product and a reconstitution section having a vial for holding a drug, wherein the device can be adjusted from a locked state to an activated state, and the injection section may only be disassembled from the reconstitution section after the device reaches the activated state.

2. A pre-assembled reconstitution and injection device, comprising an injection section and a reconstitution section, wherein the reconstitution section comprises a housing which houses a vial socket which holds a vial, the vial socket having vial socket tabs, and wherein a housing interior comprises vial socket tab unlocking profiled ribs and vial socket tabs activation profiled ribs, whereby the vial socket can rotate in the housing by way of the vial socket tabs moving in the vial socket tab unlocking profiled ribs, and the vial socket can move up the housing by way of the vial socket tabs moving along the vial socket tab activation ribs.

3. The pre-assembled reconstitution and injection device of claim 2, wherein the reconstitution section further comprises a vial needle hub having a vial needle hub lower body in which a reconstitution needle is fixed and extends both above and below the vial needle hub lower body, and a vial needle hub upper body with vial needle hub arms having vial needle hub tabs, needle hub locking ribs and a rib opening, wherein the vial needle hub lower body fits inside the vial socket.

4. The pre-assembled reconstitution and injection device of claims 2 or 3, in which the injection section comprises a cartridge holder which holds the cartridge, the cartridge has a first open end into which fits a cartridge plunger attached to a plunger rod, which plunger rod extends out of the first open end of the cartridge holder, and a second open end of the cartridge holder comprises a needle attachment means.

5. The pre-assembled reconstitution and injection device of claims 4, in which the cartridge holder further comprises one or more cartridge holder windows.

6. The pre-assembled reconstitution and injection device of any one of claims 4 to 5, in which the vial socket further comprises a vial socket body, a vial socket base, vial socket members on the vial socket body having protruding knobs for moving inside L-shaped keyways in the housing, and vial socket arms extending from the vial socket body.

7. The pre-assembled reconstitution and injection device of claim 5, wherein the vial socket further comprises one or more vial socket windows.

8. The pre-assembled reconstitution and injection device of any one of claims 4 to 7, wherein the reconstitution section further comprises a spring and a locking sleeve, wherein the locking sleeve comprises locking sleeve body extending from which are locking sleeve latches and locking sleeve backstop ribs, and wherein the spring is between the vial needle hub upper body and the locking sleeve body.

9. The pre-assembled reconstitution and injection device of claim 8, wherein the housing interior further comprises a horizontal rib and upper ribs that lock the locking sleeve in place when the injection section is removed from the reconstitution section as the horizontal rib secures the locking sleeve backstop ribs, preventing the locking sleeve from being ejected from the reconstitution section.

10. The pre-assembled reconstitution and injection device of any one of claims 4 to 9, wherein the cartridge holder further comprises first cartridge holder tabs, and the housing interior, at a top housing body opening, comprises a first cartridge holder keyway for receiving the first cartridge holder tabs.

11. The pre-assembled reconstitution and injection device of claim 10, wherein the vial needle hub blocking rib of the vial needle hub blocks the rotation of the first cartridge holder tabs in the first cartridge holder key way.

12. The pre-assembled reconstitution and injection device of any one of claims 4 to 11, wherein the housing interior further comprises lower recesses and upper recesses for holding the vial needle hub tabs.

13. The preassembled reconstitution and injection device of any one of claims 4 to 12, wherein the cartridge holder further comprises cartridge holder latches, and the plunger rod further comprises a first plunger rod rib, a backstop plunger rod rib, and a dosageplunger rod rib, wherein the cartridge holder latches stop the plunger rod from being withdrawn beyond any of the first plunger rod rib, backstop plunger rod rib, and dosage plunger rod rib once any of the plunger rod ribs move past the cartridge holder latches.

14. A method of adjusting the pre-assembled reconstitution and injection device of claim 13 from the locked state to the activated state through the steps of: rotating the vial socket base of the vial socket so that the protruding knobs move in the L-shaped key way of the housing as the vial socket tabs rotate in the housing vial socket tab unlocking profiled ribs; pushing the vial socket base against a hard surface so that the vial socket moves up the housing by way of the vial socket tabs moving up the vial socket tab activation profiled ribs and the protruding knobs moving up the L-shaped keyways, causing the reconstitution needle to pierce the vial; wherein the vial socket arms come up against the ends of the vial needle hub arms, causing the vial needle hub arms to move inward, such that the vial needle hub moves upwards with the vial socket until the vial needle hub tabs move from the lower recesses in the housing to the upper recesses in the housing; the cartridge is pierced by the reconstitution needle when the protruding knobs have moved to the top of the L-shaped keyways and the vial needle hub tabs are in the upper recesses of the housing; the vial needle hub blocking rib moves out of the first cartridge holder key way to permit the movement of the first cartridge holder tabs in the first cartridge holder key way; the plunger rod is depressed and the diluent in the cartridge is transferred to the vial containing a drug through the reconstitution needle; the device is swirled to combine the drug and diluent to an admixture; the device is rotated approximately 180 degrees, and the plunger is pulled back to transfer the admixture from the vial to the cartridge through the reconstitution needle; wherein the first cartridge holder tabs are moved out of the first cartridge holder key way permitting the injection section to be removed from the reconstitution section; wherein the spring pushes the locking sleeve, causing it to move up to the top housing body opening causing the locking sleeve latches to engage with the horizontalrib to prevent the locking sleeve from being ejected from the reconstitution section and blocking the re-attachment of the injection section to the reconstitution section.

15. The method of claim 14, wherein a pen needle assembly is attached to the needle attachment means of the cartridge holder.

16. The pre-assembled reconstitution and injection device of claim 2, wherein the injection section further comprises a cartridge needle hub with a threaded interior for hypodermic needle attachment, a cartridge needle, a male luer connection, and cartridge needle hub latches; and the reconstitution section further comprises a needle hub with a vial needle and a female luer connection for engagement with the male luer connection.

17. The pre-assembled reconstitution and injection device of claim 16, wherein the cartridge holder comprises anti-rotation ribs, a pre-activation groove, and an activation groove, and the cartridge needle hub latches of the cartridge needle hub move from the pre-activation groove when the device is in a locked state to the activation groove when the device is in an activated state.

18. A pre-assembled reconstitution and injection device, comprising an injection section and a reconstitution section, wherein the reconstitution section comprises a housing which houses a vial socket which holds a drug vial and comprises a tamper-proof tab comprising a tab from which sides extend a pair of tab legs ending in tab leg tabs, which tab legs form a U-shape with a tab base between the tab legs and above the tab, and a base of the vial socket rests in the tab base, and on the inside of the housing comprises a pair of tab leg slots, and the vial socket is prevented from fully inserting into the housing by the tab leg tabs resting in the tab leg slots.

19. The pre-assembled reconstitution and injection device of claim 18, in which the injection device comprises a cartridge holder which holds a cartridge with a first open end into which fits a cartridge plunger attached to a plunger rod, which plunger rod extends out of a first open end of the cartridge holder, and a second open end of the cartridge holder comprises a needle attachment means, and wherein a second end of thecartridge rests in a locking ring body which has a pair of locking ring legs extending out of the second end of the cartridge holder; the housing in addition to and above the pair of tab legs slots comprises a pair of lower vial socket tabs slots, upper vial socket tab slots, lower needle hub tab slots, upper needle hub tab slots, and the vial socket has a pair of vial socket tabs, and the vial needle hub has a pair of vial needle hub tabs; the inside of the cartridge holder comprises a pair of lower locking ring tab slots and upper locking ring tab slots, and the locking ring legs end in locking ring lock tabs; the housing additionally comprises on the inside a housing lock tab, and the locking ring body additionally comprises at least one locking ring lock tab, and the cartridge holder additionally comprises a key way slot, into which the locking ring lock tab fits, and the keyway slot is bisected by a keyway finger on one side, into which the housing lock tab fits, and a keyway body on the other side.

20. A method of activating the pre-assembled reconstitution and injection device of claim 19, wherein the locking ring tabs are in the lower locking ring tab slots, vial needle hub tabs are in lower hub tab slots, and vial socket tabs are in lower vial socket tab slots, and wherein the tamper-proof tab is pulled off and the base of the vial socket is depressed on a hard surface which moves the locking ring tabs to the upper locking ring tab slots, vial needle hub tabs to the upper hub tab slots and vial socket tabs to the upper vial socket tab slots and activates the device by connecting any diluent or drug product in the cartridge to any drug in the drug vial, and pushes the locking ring lock tab up in the needle slot, which locks the vial socket and locks the locking ring inside the housing and allows the housing lock tab to be moved from the keyway finger to the keyway body and release the injection section from the reconstitution section.

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