Pressurized gas-powered liquid transfer device and system

Abstract

To provide a pressurized gas driving device and a system for transferring a medical fluid from a supply source vial to an injection device and / or mixing, diluting or reconfiguring the medicine and transferring obtained medical fluid to the injection device.SOLUTION: A transfer device for transferring a medical fluid from a vial to a medical fluid injection device includes a vial holder 142 where a vial spike positioned within the vial holder is configured to enter a vial containing a medical fluid when the vial is inserted into the vial holder. An expansion chamber 144 having an interior cavity is in fluid communication with the vial spike. A pressurized gas cartridge is positioned with the interior cavity of the expansion chamber, while a puncture tip is configured to puncture the pressurized gas cartridge when actuated by a user. The vial spike is also configured to be in fluid communication with an injection device attached to the transfer device.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] [Priority Claim] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 572,911, filed October 16, 2017, the contents of which are incorporated herein by reference in their entirety.

[0002] The present subject matter relates generally to devices for transferring fluids from a vial to a medical device, and particularly to pressurized gas-driven devices and systems for transferring liquid medications from a source vial to an injection device and / or for mixing, diluting or reconstituting medications and transferring the resulting liquid medication to an injection device. [Background technology]

[0003] Injection devices worn by patients temporarily or long-term are well known in the medical field. The subject matter of this application relates particularly, but not exclusively, to a transfer device for use with the injection device described in commonly assigned PCT Application WO 2014 / 204894, published December 24, 2014, which is incorporated herein by reference in its entirety. The injection device includes an internal elastic bladder that can be filled with any suitable injectable agent, whether a drug, antibiotic, biologic, or other injectable agent, for subcutaneous injection, typically a bolus injection, into the patient while the device is worn by the patient.

[0004] The injection device must be filled (wholly or partially) with the desired injectable agent before injecting the patient. The above-mentioned published PCT application also discloses various transfer devices for transferring an injectable agent from a source, such as one or more vials, to the injection device. In some situations, it may be necessary to dilute or reconstitute the injectable agent, and various devices for accomplishing this are disclosed in the above-mentioned application. The present application discloses additional novel designs and improvements for such transfer, dilution, and / or reconstitution transfer devices that allow for lower manufacturing costs and less waste. The transfer devices described herein may be variously referred to as transfer modules, accessories, add-ons, or other suitable terms, without intending any limitations on the structure or function of the devices not described herein. Summary of the Invention

[0005] There are several aspects of the present subject matter that may be embodied separately or together in the devices and systems described and claimed below. These aspects may be used alone or in combination with other aspects of the subject matter described herein, and the description of these aspects is not intended to exclude the use of these aspects individually or the claiming of such aspects as sets of separate or different combinations set forth in the appended claims.

[0006] In one aspect, a transfer device for transferring a pharmaceutical fluid from a vial to a pharmaceutical fluid injection device includes a vial elevator configured to receive a vial containing the pharmaceutical fluid and a vial elevator shaft within which the vial elevator moves between an extended position and a retracted position. A vial spike is disposed within the vial elevator shaft, and the vial spike is disposed within the vial when the vial elevator is in the retracted position. An expansion chamber has an internal cavity, and a pressurized gas cartridge is disposed within the internal cavity of the expansion chamber. A puncture tip is configured to puncture the pressurized gas cartridge when activated by a user. The vial spike is in fluid communication with the internal cavity of the expansion chamber and is configured to provide fluid communication between an injection device attached to the transfer device and a vial disposed within the vial elevator when the vial elevator is in the retracted position and the vial spike is disposed within the vial.

[0007] In another aspect, a transfer device for transferring a medication fluid from a vial to a medication fluid injection device includes a vial holder. The vial holder includes a vial spike disposed within the vial holder. The vial spike is configured to enter a vial containing the medication fluid when the vial is inserted into the vial holder. An expansion chamber has an internal cavity in fluid communication with the vial spike and the pressure release hole. A pressurized gas cartridge is disposed within the internal cavity of the expansion chamber. The puncture tip is configured to puncture the pressurized gas cartridge when actuated by a user. The vial spike is configured to be in fluid communication with an injection device attached to the transfer device. A plunger rod is slidably disposed within the pressure release hole and configured to move between a closed position and a vent position.

[0008] In yet another aspect, a transfer device for transferring a medication fluid from a vial to a medication fluid injection device includes a vial holder. The vial holder includes a vial spike disposed within the vial holder. The vial spike is configured to enter a vial containing the medication fluid when the vial is inserted into the vial holder. The expansion chamber has an internal cavity in fluid communication with the vial spike. A pressurized gas cartridge is disposed within the internal cavity of the expansion chamber. The puncture tip is configured to puncture the pressurized gas cartridge when activated by a user. The vent filter includes a housing. The housing includes a fluid inlet, a liquid outlet, a gas outlet, a hydrophilic membrane disposed within the housing and in fluid communication with the fluid inlet and the liquid outlet, and a hydrophobic membrane disposed within the housing and in fluid communication with the fluid inlet and the gas outlet. The vial spike is configured to provide medication fluid from a vial inserted in the vial holder to the fluid inlet of the vent filter, such that a liquid portion of the medication fluid flows through the hydrophilic member and out of the housing through the liquid outlet. The liquid outlet is configured to be in fluid communication with an injection device attached to the transfer device. The gas portion of the medication fluid flows through the hydrophobic membrane and exits the housing through the gas outlet. [Brief explanation of the drawings]

[0009] FIG. 1 is a schematic diagram of a single vial pressurized gas-powered transfer system and injection device.

[0010] FIG. 2 is a schematic diagram of a dual vial pressurized gas-driven transfer system and injection device.

[0011] FIG. 3A is a perspective view of one embodiment of a pressurized gas-powered transfer device of the present disclosure having an injection device attached thereto.

[0012] 3B is a perspective view of the pressurized gas-powered transfer device of FIG. 3A with the injection device removed.

[0013] FIG. 4 is an exploded view of the pressurized gas-powered transfer device of FIGS. 3A and 3B.

[0014] FIG. 5A is an enlarged perspective view of the vial holder of the pressurized gas powered transfer device of FIGS. 3A-4 with the vial elevator in the raised or extended position.

[0015] FIG. 5B is a perspective view of the vial holder of FIG. 5A with the vial elevator in a retracted or lowered position.

[0016] FIG. 6 is a perspective view of the vial elevator of the vial holder of FIGS. 5A and 5B.

[0017] FIG. 7 is a cross-sectional view of the vial holder of FIGS. 5A to 6 taken along a horizontal cutting plane.

[0018] FIG. 8 is an enlarged perspective view of the stop tabs, stop pins, locking arms and locking pawls of the vial elevator and the elevator shaft cam ramps of the vial elevator shaft of the vial holder of FIGS. 5A-7.

[0019] FIG. 9 is an enlarged perspective view of a lock shoulder of the lock arm of the vial elevator of FIGS. 5A to 8. FIG.

[0020] FIG. 10 is a first perspective view of the vial spike hub assembly of the injection device of FIGS. 3A-4.

[0021] FIG. 11 is a second perspective view of the vial spike hub assembly of the injection device of FIGS. 3A-4.

[0022] FIG. 12A is a side view of the vial spike hub assembly of FIGS. 10 and 11 with the hub cap removed prior to insertion of the vial spike into the vial.

[0023] FIG. 12B is a side view of the vial spike hub assembly of FIG. 12A during initial insertion of the vial spike into the vial.

[0024] FIG. 12C is a side view of the vial spike hub assembly of FIGS. 12A and 12B with the vial spike fully inserted into the vial.

[0025] FIG. 13 is a cross-sectional view of the gas tube of the vial spike hub assembly of FIGS. 10 and 11 before crimping.

[0026] FIG. 14 is a cross-sectional view of the gas tube of the vial spike hub assembly of FIGS. 10 and 11 after crimping.

[0027] FIG. 15 is a first perspective view of the vial hub assembly and pressurized gas extension chamber of the transfer device of FIGS. 3A-4.

[0028] FIG. 16 is a second perspective view of the vial hub assembly and pressurized gas extension chamber of the transfer device of FIGS. 3A-4.

[0029] FIG. 17 is a perspective view of the chamber bottom of the pressurized gas expansion chamber of the transfer device of FIGS. 3A to 4. FIG.

[0030] FIG. 18 is an enlarged perspective view showing the pressurized gas canister located at the bottom of the chamber of FIG.

[0031] FIG. 19 is a top perspective view of an upper chamber portion of the pressurized gas expansion chamber of the transfer device of FIGS. 3A to 4. FIG.

[0032] FIG. 20 is a bottom perspective view of the upper chamber of the pressurized gas expansion chamber of the transfer device of FIGS. 3A to 4. FIG.

[0033] FIG. 21 is an enlarged cross-sectional view of the gas cartridge piercing mechanism of the transfer device of FIGS. 3A-4.

[0034] FIG. 22 is a second cross-sectional view of the gas cartridge piercing mechanism of the transfer device of FIGS. 3A-4.

[0035] 23 is an enlarged top view of the elevator and flexible wall cam ramp of the gas cartridge piercing mechanism of FIGS. 21 and 22. FIG.

[0036] FIG. 24 is an enlarged cross-sectional view showing the elevator cam ramps of the vial elevator engaging with the locking tabs on the base plate.

[0037] FIG. 25 is an enlarged top view of the pinch tube extension and blade of the vial holder of the transfer device of FIGS. 3A-4.

[0038] FIG. 26A is an enlarged side view of the pinch tube blade of FIG. 25 beginning to engage the transfer tube of the transfer device of FIGS. 3A-4.

[0039] FIG. 26B is an enlarged side view of the pinch tube blade of FIG. 25 engaging the transfer tube of the transfer device of FIGS. 3A-4.

[0040] FIG. 27 is a cross-sectional view of the ventilation filter of the transfer device of FIGS. 3A-4 taken along a vertical cutting plane.

[0041] FIG. 28 is a side view of the retaining strap of the transfer device of FIGS. 3A-4.

[0042] FIG. 29 is an enlarged perspective view of the open hinge tabs of the retaining ring of the transfer device of FIGS. 3A-4.

[0043] FIG. 30A is a cross-sectional view of the pressure relief assembly of the transfer device of FIGS. 3A-4 along a vertical cutting plane with an injection device attached, prior to use of the device.

[0044] FIG. 30B is a cross-sectional view of the pressure relief assembly of the transfer device of FIGS. 3A-4 taken along a vertical cutting plane during a first portion of the injection stage.

[0045] FIG. 30C is a cross-sectional view of the pressure relief assembly of the transfer device of FIGS. 3A-4 taken along a vertical cutting plane during a second portion of the injection stage.

[0046] FIG. 30D is a cross-sectional view of the pressure relief assembly of the transfer device of FIGS. 3A-4 taken along a vertical cutting plane during the final venting stage.

[0047] FIG. 31 is an enlarged perspective view of a retaining ring of the transfer device of FIGS. 3A-4.

[0048] FIG. 32 is an enlarged view of a portion of the retaining ring of FIG. 31 showing cooperating posts for retaining the adhesive liner tab or safety strip of the injection device. DETAILED DESCRIPTION OF THE INVENTION

[0049] As described in commonly assigned, previously published PCT application WO 2016 / 154413, which is incorporated herein by reference in its entirety, FIG. 1 is a schematic diagram of a single-vial transfer system including a pressure vessel in the form of a pre-filled pressurized gas cylinder or cartridge 100, a flow restrictor and / or pressure regulator 101, a liquid drug vial 102, and an injection device 103. The gas cylinder may be any suitable commercially available cylinder or a custom cylinder. For example, a variety of possible cylinders are available, including high-pressure gas-filled disposable cylinders with capacities ranging from 1 to 1000 cc. The cylinders may be filled to suitable pressures of 2000 to 3000 psig or greater. It should be understood that relatively small-volume disposable cylinders are suitable for the present subject matter. For example, the cylinder may have a volume of 10 ml or less, more preferably less than 5 ml, such as 1 to 2 ml, and be pressurized to 500 psig or greater, such as from 900 psig to 2000 to 3000 psig.

[0050] The gas may be any suitable gas, including, but not limited to, an inert gas. Because the gas will be in contact with the medication, it is preferable that the gas be pathogen-free, i.e., free of active pathogens. Nitrogen or argon may be suitable gases. Upon release from the cylinder, such as by puncturing with a puncture pin, the gas is directed through a suitable flow path from the cylinder through a flow restrictor and / or pressure regulator 101 to the vial 102. Alternatively, the gas exiting the cylinder may be directed through a filter having a pore size of 0.2 μm or less to filter the gas.

[0051] The flow restrictor and / or pressure regulator 101 may be of any suitable configuration. By way of example only, in the disclosed embodiments described below, the flow restrictor and pressure regulator may take the form of a chamber formed within the device within which the cartridge is placed and to which the vial 102 and injection device 103 are attached. From the restrictor / regulator, a flow path 104 directs gas to the vial 102. The restrictor / regulator may take the form of a filter as described above.

[0052] Vial 102 may be a standard drug vial having a rigid container portion 105, usually glass, open at one end and sealed by a pierceable diaphragm or septum 106 of latex, silicone or other material. The process of the present invention is preferably carried out with the vial in an inverted vertical position so that gas flows into the closed end of the vial, forcing essentially all of the drug out of the vial under the force of the pressurized gas.

[0053] From the vial, flow path 107 directs the medication under gas pressure to a suitable container, such as injection device 103, examples of which are described in the commonly assigned, previously published PCT application WO 2014 / 204894, as noted above. The injection device can have a liquid reservoir, such as an expandable reservoir for receiving the medication, e.g., a reservoir that expands under pressure from the medication. When removed from flow path 107, the reservoir may be biased to release the medication when the user activates the injection device. By way of example only, the injection volume can be 1 to 50 mL.

[0054] It should be noted that terms such as "injectable fluid," "injectable," "drug," "medication," and the like are used interchangeably herein.

[0055] The underside of the injection device 103 may include a fill port 108 and a dispense port 112. As shown in FIG. 1 , the fill port 108 is an interface that allows the transfer device fill path 107 to transfer liquid to the injection device 103. The fill port 108 preferably includes a check valve that prevents the pressurized injection from leaking from the injection device 103 when the injection device is detached from the transfer device and the fill port 108 is detached from the fill path 107.

[0056] The medication is released from the injection device 103 through an injection cannula that passes through the dispensing port 112 .

[0057] For purposes of illustration and not limitation, Figure 2 is a schematic diagram of a pressurized gas-powered dual-vial resuspension and transfer system including a pressure vessel in the form of a pre-filled pressurized gas cylinder or cartridge 120, a flow restrictor and / or pressure regulator 121, a liquid diluent vial 122D, a drug vial 122M, and the injection device 103 of Figure 1. (Each vial 122D, 122M may also contain a liquid drug.) As in Figure 1, gas cylinder 120 may be any suitable commercially available cylinder or may be a custom cylinder.

[0058] Also, as with the single vial system, the gas may be any suitable gas, preferably, but not limited to, pathogen-free, i.e., an inert gas that does not contain active pathogens. Upon release, such as by puncturing with a puncture pin, the gas is directed from the cylinder through a flow restrictor and / or pressure regulator 121 to the diluent vial 122D via an appropriate flow path. Alternatively, the gas exiting the cylinder may be directed through a filter having a pore size of 0.2 μm or less to filter the gas.

[0059] 1, flow restrictor and / or pressure regulator 121 may be of any suitable configuration, including a chamber formed within the device within which the cartridge is placed and to which vials 122D, 122M and injection device 103 are attached. From the restrictor / regulator, flow path 124 directs gas to vial 122D. The restrictor / regulator may take the form of a filter as described above.

[0060] Diluent (or first liquid drug) vial 122D and drug (or second liquid drug) vial 122M may each be a standard drug vial having a rigid container portion, usually glass, open at one end and sealed by a pierceable diaphragm or septum 126D, 126M of latex, silicone, or other material. The process of the present invention is preferably carried out with the vials in an inverted vertical position so that gas flows into the closed end of the vial, forcing essentially all of the diluent and / or drug out of the vial under the force of the pressurized gas before the gas exits the drug vial.

[0061] Flow path 127D conducts the diluent (or liquid drug) under gas pressure from diluent (or first liquid drug) vial 122D to drug vial 122M, where it can resuspend the drug if in a dry state such as a lyophilized form, or dilute the drug if in a liquid concentrated form (or simply combine or mix with the drug if in a liquid non-concentrated form). From drug vial 122M, the combined drug and diluent or diluted or mixed liquid drug flows under gas pressure through flow path 127M to any suitable container, such as injection device 103 disclosed in the previously-identified PCT application.

[0062] An embodiment of the pressurized gas-powered transfer device of the present disclosure is generally designated 140 in Figures 3A and 3B. The transfer device includes two main parts: (1) a vial holder generally designated 142, and (2) a gas expansion chamber generally designated 144. As shown in Figure 3A and described in more detail below, an injection device 103 can be docked to the expansion chamber 144 to receive a liquid medication.

[0063] Although the embodiments disclosed below use a single vial, alternative embodiments include transfer stations that can accommodate two or more vials in the manner shown in FIG.

[0064] Additionally, while the transfer device embodiments discussed below are single-use, disposable devices, alternative embodiments include reusable transfer devices.

[0065] Vial holder 142 includes a vial elevator shaft, generally designated 146 in Figures 4, 5A, and 5B. Housed therein is a vial elevator 148. Vial elevator shaft 146 is fixed to a base plate 150 (Figure 4) of the transfer device. Vial elevator 148 slides vertically within vial elevator shaft 146 in a telescopic manner between an extended position, shown in Figure 5A, and a retracted position, shown in Figure 5B.

[0066] As shown in FIG. 6, vial elevator 148 includes a circular rim 152 from which locking arms 154a-154d extend downward. Additionally, splines 156a, 156b (also shown in FIG. 7) extend downward from rim 152, as do actuating arms 158 for a pressurized gas cylinder piercing mechanism. Stop tabs 162a-162d extend radially from the central bottom of the elevator and each feature a stop pin 164a-164d. An opening 166 is formed in the center of the bottom of vial elevator 148 to receive an upward-facing vial spike attached to the bottom of base plate 150 (FIG. 4), as described in more detail below.

[0067] As shown in FIG. 7, the vial elevator shaft 146 has a sidewall 168 that includes inward channels 174a, 174b for slidingly receiving the splines 156a, 156b of the vial elevator 148 to provide radial alignment of the vial elevator within the vial elevator shaft and to provide a smooth transition as the vial elevator moves.

[0068] As shown for lock arm 154a in Figure 8, vial elevator shaft sidewall 168 also features an inwardly extending cam ramp 170a (Figure 8). Similar cam ramps are provided for lock arms 154b-154d.

[0069] As further illustrated in Figure 8, the distal or lower end of locking arm 154a includes a pawl 176a, while the upper portion of locking arm 154a includes a vial lock shoulder 178a, with reference to Figure 9. Locking arms 154b-154d feature similar structure.

[0070] In operation, as shown for vial 102 in Figure 1, an inverted vial is lowered into vial elevator 148 when the vial elevator is in the extended position (Figure 5A) until a downward-facing surface is formed by the septum (106 in Figure 1) or until the edge of the vial engages stop pins 164a-164d (Figure 6) of stop tabs 162a-162d. The user then gently pushes down on the vial, causing vial elevator 148 to move downward into vial elevator shaft 146 to the retracted position shown in Figure 5B.

[0071] As the vial elevator 146 moves downward toward the retracted position shown in FIG. 5B, the pawls (176a in FIG. 8) on the distal ends of the locking arms 154a-154d are moved inward by the bias of the elevator shaft cam ramps (170a in FIG. 8). As this occurs, the downward-facing end faces of the vial (the septum and / or vial rim) push downward against the stop pins 164a-164d, thereby forcing downward the distal ends of the stop tabs 162a-162d of the vial elevator 148. When the vial elevator 148 reaches the retracted position shown in FIG. 5B, the vial lock shoulders (178a in FIG. 9) of the locking arms 154a-154d have moved into a position where they engage the neck (180 in FIG. 1) of the vial 102. As a result, the vial is locked within the vial holder 142.

[0072] By way of example only, each vial may have a volume of 1 to 50 mL with a neck finish of 13 to 20 mm.

[0073] If a user attempts to push the vial elevator 148 of FIGS. 4-6 downward into the vial elevator shaft of FIGS. 4-5B without a vial in the vial elevator, the inward-moving pawls (176a of FIG. 8) on the distal ends of the locking arms 154a-154d engage with the distal ends of the stop tabs 162a-162d, as shown in FIG. 8. This prevents the vial elevator 148 from moving to the retracted position of FIG. 5B. The spacing from the bottom of the vial elevator 148 to the bottom of the base plate (150 of FIG. 4) is such that when the locking arm pawls engage the stop tabs, the tips of the vial spikes, which are positioned on the bottom of the vial holder base, are below the bottom of the vial elevator (i.e., the upward-pointing vial spikes have not yet passed through the openings 166 in the elevator bottom). As a result, the user is protected from pricking their fingers with the vial spikes.

[0074] As previously mentioned and illustrated in Figures 4, 10, and 11, vial spike 182 is attached to the bottom of base plate 150 via vial spike hub 184. The vial spike has a sharp tip that passes through the vial's diaphragm or septum (106 in Figures 1, 12B, and 12C) and has two flow paths: one for the inflow of compressed gas to force liquid out of the vial, and one for the outflow of liquid to the injection device.

[0075] 4, 10, and 11, vial spike hub 184 includes a housing 192 having a gas inlet fitting 194 and a fluid outlet fitting 196. The fluid outlet fitting may optionally be included in a hub cap 198 that is secured to housing 192 to provide access to the housing cavity (202 in FIGS. 12A-12C) during assembly.

[0076] 10-12C, vial spike 182 may take the form of a cannula, preferably constructed from stainless steel, having a sharpened tip 204 and liquid openings 206, 208. A semi-flexible gas tube 212, preferably constructed from polyamide, features a gas exit opening 214 and extends through vial spike 182 as well as vial spike hub cavity 202 and gas inlet fitting 194. As described in more detail below, the lower end of gas tube 212 is in selective fluid communication with a source of pressurized air or gas.

[0077] For gas entering through gas tube 212 to reach the headspace of a vial, such as vial 102 of Figures 12B and 12C, it must be able to pass through liquid openings 206, 208 of the vial spike and reach the top surface of the liquid medication in the vial. As a result, as shown in Figures 10 and 11, gas tube opening 214 is generally positioned higher than liquid openings 206, 208 of vial spike 182 when pressurized gas is introduced into the vial.

[0078] Cavity 202 allows gas tube 212 to bend within vial spike hub housing 192 to prevent gas tube 212 from buckling or bending against the vial's diaphragm or septum (106 in FIGS. 12B and 12C) as vial spike 182 moves therethrough. More specifically, with reference to FIG. 12A, prior to insertion of vial spike 182 into a vial, gas tube 212 is in its natural, extended position, with gas exit opening 214 extending directly below the pointed tip 214 of vial spike 182.

[0079] Referring to FIG. 12B, when the vial spike 182 is inserted into the septum 106, the upper end of the gas tube 212 is pressed down into the vial spike 182 by the septum, protecting it from bending and buckling. The gas tube 212 has column strength that biases it to want to remain straight when no external force is applied to it. As illustrated in FIG. 12B, these properties allow the gas tube 212 to flex downward within the cavity 202 of the vial spike hub housing 192 when a downward force is applied to the tip of the tube (such as the force applied by the vial septum 106 in FIG. 12B). Because the gas tube 212 has an affinity for remaining straight, once the septum is seated on the vial spike, the force of the vial septum 106 is transferred from the upper end of the gas tube 212 to the vial spike 182, after which it springs back to its original extended position, as shown in FIG. 12C.

[0080] After the vial spike and gas tube are fully positioned in the vial, pressurized air is released through the gas tube and gas tube opening into the vial headspace. The tip of the gas tube (extended position) with the gas outlet opening is usually higher than the fluid outlet opening of the vial spike, allowing air to bubble up through the liquid medication into the headspace or closed end of the vial.

[0081] An optional feature of the gas tube 212 that helps the gas reach the top of the vial is the shape of the gas tube opening 214 at the tip of the gas tube. Rather than a circular opening shape (Figure 13), the gas tube 212 is pinched at the tip, creating a thin, long oval shape at the gas tube opening 214 (Figure 14). This shape acts as a restriction at the tube's exit point. This allows the gas to escape from the tube at high velocity, preventing the gas from having an opportunity to be drawn into the vial spike's liquid flow path. This concept is best explained as being similar to someone restricting the flow of water from a garden hose by placing their thumb / finger over the outlet. Doing this increases the velocity of the fluid flow exiting the tube.

[0082] When pressurized gas is introduced into the vial headspace, the liquid in the vial is forced out through the vial spike liquid outlets 206, 208 (Figures 10 and 11). This liquid flows into the vial spike hub cavity 202 (Figures 12A-12C) and exits through the fluid outlet fitting 196 (Figures 10 and 11). Residual fluid in this subassembly should be reduced as much as possible. To accomplish this, the fluid outlet fitting 196 is positioned near the bottom of the cavity 202.

[0083] 15 and 16, gas tube 212, which passes through gas inlet fitting 194 (or simply cavity 202) of vial spike hub housing 192, is joined or connected to flexible transfer tube 222. The opposite end of transfer tube 222 is connected to a gas expansion chamber, generally designated 144, which serves as a source of pressurized gas for pressurizing the vial in the manner described above.

[0084] 4 and 15-17, the gas expansion chamber 144 includes an upper expansion chamber portion 226 and a lower expansion chamber portion 228. As shown in FIG. 15, the transfer tube 222 is connected to a pressurized gas supply port of the gas expansion chamber 144. As shown in FIG. 4, the bottom portion 228 of the expansion chamber is received by the base plate 150 of the transfer device.

[0085] 17 and 18, the expansion chamber bottom 228 defines an expansion chamber interior cavity 230 and includes a bracket 232 configured to hold and support a gas cartridge 234 (also shown in FIG. 4) containing a compressed gas, such as compressed nitrogen. Of course, cartridges containing other types of compressed or pressurized gas can be used.

[0086] As shown in Figures 17 and 19, ribs 236, 238 are formed on the bottom surfaces of the chamber top 226 and chamber bottom 228, respectively, to support the chamber and limit deflection or bursting. The upper surface of the chamber top 226, shown in Figure 20, is provided with a recess 242 for holding a filter through which fluid passes from the vial spike hub to an injection device attached to the transfer device, as described in more detail below.

[0087] Chamber posts 244 (FIG. 17) on the edges of the chamber bottom 228 align with openings formed in tabs 246 (FIG. 19) extending from the chamber top 226 (also shown in FIG. 4) when they are assembled. The chamber top and bottom can then be glued together. The chamber posts 244 also mate with hexagonal holes on the retaining ring, shown at 250 in FIG. 4, to keep it attached to the device. The X-posts, shown at 252 in FIG. 17, allow for additional bonding surface and prevent the large surface area of ​​the chamber top 226 from flexing when the gas expansion chamber's internal cavity (230 in FIG. 17) is pressurized. Flexible wall supports on the base plate 150, shown at 254 in FIG. 4, provide additional support to the gas expansion chamber's sidewalls 256 (FIGS. 4 and 15-17) when the gas expansion chamber is pressurized.

[0088] The interior cavity 230 of the expansion chamber 144 is pressurized when a gas cartridge 234 (FIGS. 4 and 18) disposed therein is punctured. The cartridge puncturing mechanism for accomplishing this will now be described.

[0089] 4, 15, 16, 21 and 22, flexible wall 260 features an inner surface that holds a sharpened piercing tip 264 and an outer surface that is provided with flexible wall cam ramps 266. By way of example only, flexible wall 160 may be constructed of plastic having a thickness of approximately 0.030 inches for flexibility.

[0090] Flexible wall 260 is positioned to cover an opening, designated 268 in Figures 17, 21, and 22, through which piercing tip 264 passes, as shown in Figures 21 and 22. The flexible wall is glued in place with an adhesive and then sandwiched between support ribs 274 (Figures 4, 21, and 22) formed on base plate 150 after the transfer device is assembled. Referring to Figure 4, support ribs 274 feature vertical slots 276 that accommodate flexible wall cam ramps 266.

[0091] As previously discussed with reference to Figure 6, the actuator arm 158 extends downwardly from the lip 152 of the vial elevator 148. This is also shown in Figure 22. As shown in Figures 4, 6, 22 and 23, the distal end of the actuator arm 158 is provided with an elevator cam ramp 278.

[0092] When a vial is inserted into the vial elevator (148 in FIGS. 4-6) and the vial elevator is pushed down so that it retracts into the vial elevator shaft (146 in FIGS. 4-5B), the vial elevator's actuation arm 158 moves downward, causing the elevator cam ramp 278 to interact with the flexible-wall cam ramp 266, as shown in FIGS. 22 and 23, to move the central portion of the flexible wall 260, and thus the puncture tip 264, inward, puncturing the end of the pressurized gas cartridge 234 (also shown in FIG. 18). In doing so, the flexible wall elastically deforms concavely (as viewed from outside the gas expansion chamber 144). The flexible-wall cam ramp 266 and the elevator cam ramp each preferably feature a 20-degree angle (from vertical) to reduce the force and displacement required to bend and move the central portion of the flexible wall 260.

[0093] The shape and volume of the internal cavity 230 (FIG. 17) of the gas expansion chamber 144 are such that the pressure of the gas supplied to the transfer tube 222, and therefore the pressure of the gas provided to the vial spike hub and vial, is less than the pressure of the gas in the gas cartridge 234 (FIG. 18). As a result, the internal cavity 230 functions as a pressure regulator.

[0094] Referring to FIG. 22, the elevator shaft wall 168 features a pin 282 that is received by an opening formed in the chamber top 226, thereby linking the elevator shaft to the expansion chamber and limiting movement from the top of the elevator shaft, which helps ensure puncture of the gas cartridge.

[0095] Support ribs 274 on the base plate 150 limit the vertical movement of the flexible wall cam ramps 266 which helps eliminate backlash that can cause misfires.

[0096] As illustrated in Figures 18 and 22, the angle at which the piercing tip 264 engages the pressurized gas cartridge 234 is preferably such that it forces the piercing tip into the corner of the piercing area of ​​the cartridge, i.e., the thinnest wall of the cartridge, creating the smallest piercing load.

[0097] 22 and 24, the base plate also features an elevator locking tab 284 that flexes out of the way when the vial elevator is retracted into the vial elevator shaft and the vial elevator cam ramp 278 passes over it. Then, as shown in FIG. 24, the elevator locking tab 284 flexes back over the elevator cam ramp 278, preventing removal of the vial from the vial elevator after transfer of the vial contents has begun.

[0098] A tubing pinch extension, designated 286 in Figures 5B, 7, 25, 26A and 26B, defines a slot 288 on the elevator shaft that serves as a holding location for the transfer tube 222 (Figures 15, 16, 26A and 26B) extending between the pressurized gas expansion chamber and the gas tube of the vial spike hub.

[0099] The vial elevator includes a tube pinch blade with a sloped bottom, shown at 292 in Figures 6, 7, 25, 26A and 26B, and at 294 in Figures 6 and 26A. The tube pinch blade 292 passes through a corresponding opening in the tube pinch extension (295 in Figure 25).

[0100] As shown in Figures 26A and 26B, as the vial elevator and vial descend to a retracted position within the vial elevator shaft, the tube pinch blade 292 travels through the pinch tube extension 286 and pinches the transfer tube 222 against the edges defining the slot 288 of the pinch tube extension until the vial elevator is in its fully retracted position (Figure 5B). One aspect of the system is the timing at which the gas cylinder is punctured and gas is introduced into the vial. As the vial is inserted into the elevator and pushed to the end of its travel, the elevator interacts with a flexible wall to puncture the gas canister. It is desirable for the vial spike to be in the vial before pressurized gas enters the vial. Once the tube is pinched and punctures the gas canister during elevator movement, there is no flow of pressurized gas to the vial until the vial spike is fully inserted into the vial (i.e., when the vial elevator of FIG. 5B is in its fully retracted position). As shown in FIG. 25, pinch blade 292 preferably features an arrowhead shape, with the tip of the arrowhead (296 in FIG. 25) pinching the tube and the flat portion of the rear of the arrowhead pinching the tube by abutting against the corresponding side of opening 295 against a normal force.

[0101] Transfer tube 222 is preferably constructed of tubing that is rigid enough to be able to be pinched and released without impeding air flow. By way of example only, transfer tube 222 may be PVC or other compatible tubing having an inner diameter of 0.030 inches and an outer diameter of 0.060 inches.

[0102] As previously explained, the liquid within the vial is forced by the pressurized gas to exit the vial spike, vial spike hub cavity 202 (FIGS. 12A-12C), and out the vial spike hub's fluid outlet fitting 196 (FIGS. 15 and 16). As shown in FIGS. 15 and 16 (and FIG. 3B), a fluid transfer line 290 directs the fluid from the fluid outlet fitting 296 to a vent filter, designated 293 in FIGS. 3B, 15, and 16. A schematic diagram of the vent filter is shown in FIG. 27. The vent filter is generally designated 293.

[0103] The vent filter is used to expel front-end and rear-end air from the system during drug delivery, preventing air from entering the injection device. More specifically, as explained above, a puncture is made in the pressurized canister, which is used as the driving force to force the liquid and air out of the vial. The empty fluid transfer line 290 between the vial spike hub and the vent filter 293 is filled with front-end air that must be expelled from the system before the liquid is forced into the injection device.

[0104] 27, the vent filter includes a housing 297 having a fluid inlet port 299 to which a fluid transfer line 290 is connected, an air outlet port 311, and a liquid outlet port 313 (also shown in FIG. 3B) to which a fill port of an injection device (103 in FIG. 3A) is connected to receive liquid. The housing also includes a hydrophilic membrane 315 and a hydrophobic membrane 317, between which a fluid chamber 319 is disposed. The fluid chamber 319 receives fluid from the fluid transfer line 290. As a result, front-end air trapped in the fluid path passes through the hydrophobic membrane 317 and exits through the air outlet port 311 into the atmosphere. The filtered liquid passes through the hydrophilic membrane 315 and exits through the liquid outlet portion 313 to enter the injection device.

[0105] The inherent flow restriction of the hydrophilic membrane 315, coupled with the pressure required to fill the syringe, causes front-end air to be expelled. These factors cause the front-end air to find the path of least resistance as it is routed through the vent filter 293. This occurs not through the restrictive hydrophilic membrane 315 and into the syringe, but through the hydrophobic membrane 317 and air exit port 311. The hydrophilic membrane of the vent filter allows liquid to pass through it and enter the syringe. When the hydrophilic membrane becomes wet with liquid, air cannot pass through, allowing only liquid to pass through, preventing air from entering the syringe. The hydrophilic filter not only filters air, but also has the ability to prevent aggregates or particles from the formulation from being transferred into the syringe.

[0106] Once all of the liquid has been transferred to the injection device, residual air pressure still exists within the transfer device, including the expansion chamber. This air enters the filter, is blocked by hydrophilic membrane 315, exits through vent filter 293, and passes through hydrophobic membrane 317 to the atmosphere. This process continues until a certain pressure is reached within the internal cavity of the gas expansion chamber, at which point a pressure relief assembly, described below, vents the remaining pressure in the system.

[0107] The pore size of the hydrophilic membrane 315 is preferably set by the differential pressure of the delivery system and the internal pressure of the syringe device. If the pressure becomes higher than what the vent filter 293 can handle, air can enter the syringe device.

[0108] The liquid outlet port 313 can optionally accept a cannula to aid in filling the syringe device. By way of example only, the cannula may be a 19 gauge needle with a curled tip that reduces the risk of damaging the syringe device's filling septum.

[0109] As described above with reference to Figure 20, the upper surface of the upper chamber section 226 is provided with a recess 242 for holding the ventilation filter 293 (as shown in Figure 3B), which allows the overall height of the system to be reduced.

[0110] Referring to FIG. 3A, the retaining strap 301 holds the injection device 103 to the transfer device 140 during transport. Furthermore, the retaining strap 301 is intended to remain latched during the transfer of the medication from the vial to the injection device 103. Once all of the medication has been transferred to the injection device, the retaining strap 301 automatically releases, indicating to the user that the injection device is ready to be placed on the body. Additionally, a final ejection from the transfer device occurs, releasing any residual pressure in the gas expansion chamber that remains after the medication has been completely transferred to the injection device. This feature prevents the user from prematurely removing the injection device from the transfer device. Without the strap, the user may attempt to remove the injection device before all of the medication has been transferred from the vial. The mechanisms that perform these functions are now described.

[0111] 3A, 4, and 28, retention strap 301 includes a first end having a D-shaped fastener 303 and a second end featuring a hook 305 and a pair of opposing latch pins 307. As shown in FIGS. 3B, 4, and 29, retaining ring 250 is provided with a pair of open hinge tabs 309. As shown in FIG. 3A, hinge tabs 309 engage with D-shaped fasteners 303 of retention strap 301 when the strap is used to secure an injection device to a transfer device. As described in more detail below, the other end of the retention strap (including hooks 305 and latch pins 307) is secured with a pressure release assembly as shown in FIG. 3A.

[0112] As shown in Figures 4 and 17, the bottom 228 of the expansion chamber has a pressure relief hole 302. As shown in Figures 30A-30D, a pressure relief assembly, generally designated 304, is disposed within the pressure relief hole 302. As shown in Figures 4 and 30A, the pressure relief assembly includes a plunger rod 308, an O-ring 310, and a plunger rod compression spring 312. The inner end of the plunger rod 308 is provided with spaced apart collars 314a, 314b with the O-ring 310 disposed therebetween, and the outer end of the plunger rod is provided with a J-shaped slot 316.

[0113] The transfer device 140 is shown prior to use, with the injection device 103 positioned thereon and secured thereto by the retaining strap 301, in Figure 3A. The configuration of the pressure release assembly 304 corresponding to the initial state of the transfer device shown in Figure 3A is shown in Figure 30A. Referring to Figure 30A, the latch pin 307 of the retaining strap 301 engages the closed end of the J-shaped slot 316 to hold the plunger rod 308 in the position shown, against the bias of the compression spring 312 in the direction of arrow 322.

[0114] Additionally, the hook 305 of the retaining strap hooks onto a ledge 324 on the retaining ring 250 .

[0115] The configuration of pressure release assembly 304 during the injection phase is shown in Figure 30B, when the user pushes a vial into the vial elevator of the transfer device and moves it toward the retracted position to activate the transfer device and initiate the transfer of medication from the vial to the injection device.

[0116] As described above, the act of pushing the vial into the system punctures the pressurized gas cartridge (234 in FIGS. 18 and 22), thereby filling the interior cavity 230 of the pressurized gas expansion chamber 144 with pressurized gas. This pressure within the expansion chamber's interior cavity 230 urges the plunger rod 308 in the direction of arrow 326 against the bias of the compression spring 312. The plunger rod 308 is in a closed position where the O-ring 310 reduces or eliminates leakage of pressurized gas from the interior cavity 230 of the expansion chamber 144. As a result, as shown in FIG. 30B, the pin 307 of the retaining strap 301 moves toward the rounded bottom of the J-shaped slot 316 in the plunger rod 308.

[0117] 30B, retaining strap 301 is molded (preferably from plastic) to have an inherent biased spring force that causes it to swing to the right (in the direction of arrow 328). As a result, when pin 307 moves to the position shown in Figure 30B, hook 305 of retaining strap 301 moves to the position shown in Figure 30C on ledge 324 of retaining ring 250, and pin 307 moves within J-shaped slot 316 to the position shown in that figure.

[0118] At the time corresponding to Figure 30C, the transfer device has transferred fluid from the vial to the injection device, and gas pressure still exists within the interior cavity 230 of the expansion chamber 144, again holding the plunger rod 308 in the position shown in Figure 30C against the bias of the compression spring 312. Meanwhile, as shown in Figure 30C, the latch pin 307 of the retaining strap 301 contacts the wall of the J-shaped slot 316 in the plunger rod 308, thereby keeping the hook 305 latched to the ledge 324 of the retaining ring 250.

[0119] Once transfer of fluid to the injection device is complete, the vent filter 293 (FIG. 27) begins to vent the compressed air within the transfer device to the atmosphere, allowing the pressure within the interior cavity 230 of the expansion chamber 144 to decrease. As the pressure within the expansion chamber 144 decreases, the compression spring 312 begins to expand or extend (spring extension not shown), causing the plunger rod 308 to move in the direction of arrow 322 in FIG. 30A to the position shown in FIG. 30D. As a result, the latch pin 307 of the retaining strap 301 exits the open end of the J-shaped slot 316 in the plunger rod 308, and the hook 305 of the retaining strap 301 (due to the molded bias of the retaining strap) disengages from the ledge 324 of the retaining ring 250, as shown in FIG. 30D, releasing the end of the retaining strap.

[0120] The characteristics of the compression spring 312 can be selected to retract at a particular pressure in the internal cavity 230 of the expansion chamber 144, thereby unlocking the retaining strap 301 at a particular pressure.

[0121] 30D, plunger rod 308 also functions as a final air vent to relieve additional pressure within expansion chamber 144. This occurs when O-ring 310 passes through the "vent position" (shown in FIG. 30D) of pressure relief hole 302 when plunger rod 308 is in the vent position, allowing any remaining pressurized air to escape from interior cavity 230 of expansion chamber 144 past the O-ring and plunger rod.

[0122] Referring to Figure 31, the retaining ring is shown removed from the transfer device and is generally designated 250, the front finger notches are designated 332, and the rear finger notches are designated 334. The front finger notches 332 allow thumb placement for removal of the injection device when attached to the transfer device (as shown in Figure 3A), and the rear finger notches 334 allow multiple finger placement for removal of the injection device when attached to the transfer device.

[0123] 31 and 32, the retaining ring includes downwardly extending adhesive capture posts 336 that cooperate with corresponding posts 338 formed on the top of the expansion chamber 144 to mechanically capture adhesive tabs 342 on the release liner. The release liner removably covers the adhesive-covered surface of the injection device, which is used to secure the injection device to the user. As a result, the release liner remains on the transfer device when the injection device is withdrawn from the transfer device's retaining ring 250. Furthermore, the cooperating posts 336, 338 can be used to capture the distal end of a safety strip attached to the injection device to prevent accidental actuation of the injection device. Because the posts 336, 338 retain the distal end of the safety strip, when the safety strip is pulled from the transfer device's retaining ring 250, the safety strip is automatically removed from the injection device, and the injection device is thus ready to be actuated to perform an injection.

[0124] Thus, the retaining ring 250 makes assembly of the injection device to the transfer device easier. Instead of having to somehow press the injection device's safety strip and release liner adhesive tabs into the transfer device, attaching the retaining ring 250 to the expansion chamber 144 is the last step in assembly, capturing and mechanically locking the safety strip and tabs to the adhesive liner and safety strip.

[0125] While the present subject matter is described herein with reference to particular structures, methods, and examples, it will be understood that this is for purposes of illustration only, and that the present subject matter is applicable to a wide range of devices and systems employing the subject matter, but which differ in their specific configuration and appearance.

[0126] Aspect 1. a) a vial elevator configured to receive a vial containing a pharmaceutical fluid; b) a vial elevator shaft within which said vial elevator moves between an extended position and a retracted position; c) a vial spike disposed within the vial elevator shaft so as to be disposed within the vial when the vial elevator is in the retracted position; d) an expansion chamber having an internal cavity; e) a pressurized gas cartridge disposed in the interior cavity of the expansion chamber; and f) a puncturing tip configured to puncture the pressurized gas cartridge when activated by a user; g) the vial spike in fluid communication with the interior cavity of the expansion chamber and configured to be in fluid communication with an injection device attached to the transfer device and a vial disposed within the vial elevator when the vial elevator is in the retracted position and the vial spike is within the vial. and a transfer device for transferring a medicinal fluid from a vial to a medicinal fluid injection device, the transfer device comprising:

[0127] Aspect 2. further comprising a cartridge puncturing mechanism including the puncturing tip; 2. The transfer device of claim 1, wherein the cartridge puncturing mechanism is configured to puncture the pressurized gas cartridge with the puncturing tip when the cartridge puncturing mechanism is engaged by the vial elevator as the vial elevator moves toward the retracted position.

[0128] Aspect 3. the lancing mechanism includes a flexible wall having a first side on which the lancing tip is disposed and a second side on which a flexible wall cam ramp is disposed; the expansion chamber includes an opening over which the flexible wall is disposed and the puncture tip extends into the interior cavity; 3. The transfer device of claim 2, wherein the vial elevator includes a vial elevator cam ramp that engages the flexible wall cam ramp to move the puncturing tip toward the pressurized gas cartridge when the vial elevator is moved toward the retracted position.

[0129] Aspect 4. the vial elevator shaft includes a shaft cam ramp; the vial elevator includes a plurality of locking arms that are moved radially inward by the shaft cam ramps when the vial elevator is moved toward the retracted position; 2. The transfer device of claim 1, wherein each of the locking arms includes a locking shoulder configured to engage a vial inserted within the vial elevator when the vial elevator is in the retracted position.

[0130] Aspect 5. the vial elevator includes a plurality of radially extending locking tabs; each of the locking tabs includes a locking post; each of the locking arms includes a locking pawl; the locking pawl engages the locking tab to limit movement of the vial elevator toward the retracted position when the locking post is not engaged with a vial disposed within the vial elevator; 5. The transfer device of claim 4, wherein the locking tab is moved to a position where it is not engaged by the locking pawl when the vial elevator moves toward the retracted position when the locking post is engaged by a vial disposed in the vial elevator.

[0131] Aspect 6. the vial elevator includes a vial spike opening that receives the vial spike when the vial elevator is in the retracted position; Aspect 6. The transfer device of aspect 5, wherein the vial spike is configured such that when the vial elevator locking pawl engages the locking tab, the vial spike does not pass through the vial spike opening.

[0132] Aspect 7. the vial elevator includes a plurality of radially extending splines; the vial elevator shaft includes a plurality of slots;

[0013] Aspect 7. The transfer device of any one of aspects 1 to 6, wherein the splines slide within slots as the vial elevator moves between the extended position and the retracted position.

[0133] Aspect 8. the expansion chamber is in fluid communication with the vial spike via a transfer tube; the vial elevator shaft includes a slot through which the transfer tube passes; the vial elevator includes a tube pinch blade;

[0023] Aspect 8. The transfer device of any one of aspects 1 to 7, wherein the tube pinch blades are configured to pinch the transfer tube against the vial elevator shaft and release the transfer tube when the vial elevator moves from the extended position to the retracted position.

[0134] Aspect 9. the vial spike includes a liquid inlet and is attached to a vial spike hub having a hub cavity in fluid communication with the liquid inlet of the vial spike; the hub cavity is configured to be in fluid communication with an injection device attached to the transfer device; the transfer device further comprises a semi-flexible gas tube; the semi-flexible gas tube extends through the vial spike in fluid communication with the expansion chamber and has a gas exit opening; the gas outlet opening is located above the liquid inlet of the vial spike when the vial spike is in the vial and the vial elevator is in the retracted position; the gas tube is bent within the hub cavity; Aspect 9. The transfer device of any one of aspects 1 to 8, wherein the gas outlet opening is configured to retract into the vial spike upon contact of the gas tube with a vial septum during insertion of the vial spike into the vial.

[0135] Aspect 10. 10. The transfer device of embodiment 9, wherein the gas tube is formed from polyamide.

[0136] Aspect 11. a) a vial holder; b) a vial spike disposed within the vial holder and configured to enter a vial containing a pharmaceutical fluid when the vial is inserted into the vial holder; c) an expansion chamber having an internal cavity in fluid communication with the vial spike and the pressure relief hole; d) a pressurized gas cartridge disposed with the interior cavity of the expansion chamber; e) a puncturing tip configured to puncture the pressurized gas cartridge when activated by a user; f) the vial spike configured to be in fluid communication with an injection device attached to the transfer device; g) a plunger rod slidably disposed within the pressure relief hole and configured to move between a closed position and a vent position; and a transfer device for transferring a medicinal fluid from a vial to a medicinal fluid injection device, the transfer device comprising:

[0137] Aspect 12. h) a compression spring biasing the plunger rod in a first direction toward the interior cavity of the expansion chamber; i) a retaining strap configured to secure the injection device to the transfer device, the retaining strap having a first end attached to the transfer device and a second end removably attached to the plunger rod, the retaining strap limiting movement of the plunger rod in the first direction; 12. The transfer device of embodiment 11, further comprising:

[0138] Aspect 13. A transfer device as described in aspect 12, wherein the plunger rod includes a J-shaped slot into which the second end of the retaining strap is received.

[0139] Aspect 14. Aspect 14. The transfer device of aspect 12 or aspect 13, wherein the retaining strap is configured to secure the injection device to the expansion chamber.

[0140] Aspect 15. a retaining ring attached to the expansion chamber and configured to receive an injection device; A transfer device as described in aspect 14, wherein the second end of the retaining strap includes a hook that engages with the retaining ring when the second end of the retaining strap is attached to the plunger rod.

[0141] Aspect 16. an O-ring disposed on the plunger rod and engaging a sidewall of the pressure relief hole when the plunger rod is in a closed position; A transfer device as described in any one of aspects 1 to 15, wherein the O-ring does not engage with a sidewall of the pressure relief hole when the plunger rod is in the vent position so that pressurized gas in the internal cavity is vented through the pressure relief hole.

[0142] Aspect 17. a) a vial holder; b) a vial spike disposed within the vial holder and configured to enter a vial containing a pharmaceutical fluid when the vial is inserted into the vial holder; c) an expansion chamber having an internal cavity in fluid communication with the vial spike; d) a pressurized gas cartridge disposed within the interior cavity of the expansion chamber; and e) a puncturing tip configured to puncture the pressurized gas cartridge when activated by a user; f) i) a housing having a fluid inlet, a liquid outlet, and a gas outlet; ii) a hydrophilic membrane disposed within the housing and in fluid communication with the fluid inlet and the liquid outlet; iii) a hydrophobic membrane disposed within the housing and in fluid communication with the fluid inlet and the gas outlet; a ventilation filter including g) the vial spike configured to provide medicament fluid from a vial inserted within the vial holder to the fluid inlet of the vent filter, the liquid outlet being configured to be in fluid communication with an injection device attached to the transfer device, such that a liquid portion of the medicament fluid flows through the hydrophilic membrane and exits the housing through the liquid outlet, and a gas portion of the medicament fluid flows through the hydrophobic membrane and exits the housing through the gas outlet. and a transfer device for transferring a medicinal fluid from a vial to a medicinal fluid injection device, the transfer device comprising:

[0143] Aspect 18. 18. The transfer device of embodiment 17, wherein an upper portion of the expansion chamber includes a recess within which the vent filter is disposed.

Claims

[Claim 1] 1. A transfer device for transferring a medicinal fluid from a vial to a medicinal fluid injection device, comprising: a) a vial holder; b) a vial spike disposed within the vial holder and configured to enter a vial containing a pharmaceutical fluid when the vial is inserted into the vial holder; c) an expansion chamber having an internal cavity in fluid communication with the vial spike; d) a pressurized gas cartridge disposed within the interior cavity of the expansion chamber; and e) a puncturing tip configured to puncture the pressurized gas cartridge when activated by a user; f) i) a housing having a fluid inlet, a liquid outlet, and a gas outlet, said gas outlet being open to atmosphere; ii) a hydrophilic membrane disposed within the housing and in fluid communication with the fluid inlet and the liquid outlet, the hydrophilic membrane including pores configured to filter aggregates or particles from a liquid portion of the medication fluid; iii) a hydrophobic membrane disposed within the housing and in fluid communication with the fluid inlet and the gas outlet; a ventilation filter including g) the vial spike being in fluid communication with the fluid inlet of the vent filter, the liquid outlet configured to be in fluid communication with an injection device attached to the transfer device, and such that the liquid portion of the medication fluid flows through the hydrophilic membrane and exits the housing through the liquid outlet, and such that the gas portion of the medication fluid flows through the hydrophobic membrane and exits the housing through the gas outlet. and A transfer device wherein the top of the expansion chamber includes a recess in which the vent filter is disposed.

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