阅读说明：本技术 加压气体动力液体转移装置和系统 (Pressurized gas powered liquid transfer devices and systems ) 是由 D.L.鲍雷勒 D.盖格 M.J.赫德尔斯顿 J.罗威 J.R.帕尔默 D.斯蒂芬奇 于 2018-10-16 设计创作，主要内容包括：一种用于将药物流体从小瓶转移到药物流体注射装置的转移装置,包括小瓶保持器,其中当小瓶插入小瓶保持器时,位于小瓶保持器内的小瓶刺针配置为进入容纳药物流体的小瓶。具有内部腔的膨胀室与小瓶刺针流体连通。加压气体筒与膨胀室的内部腔一起定位,而穿刺尖端配置成当由使用者致动时刺穿加压气体筒。小瓶刺针还配置为与附接到转移装置的注射装置流体连通。(A transfer device for transferring a pharmaceutical fluid from a vial to a pharmaceutical fluid injection device includes a vial holder, wherein a vial spike located within the vial holder is configured to enter a vial containing the pharmaceutical fluid when the vial is inserted into the vial holder. An expansion chamber having an internal cavity is in fluid communication with the vial spike. The pressurized gas cartridge is positioned with the interior cavity of the expansion chamber, and the piercing tip is configured to pierce 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.)

1. A transfer device for transferring a medicinal fluid from a vial to a medicinal fluid injection device, comprising:

a) a vial elevator configured to receive a vial containing a pharmaceutical fluid;

b) a vial elevator well within which a vial elevator moves between an extended position and a retracted position;

c) a vial spike positioned within the vial elevator well such that the vial spike is positioned 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 positioned with the interior cavity of the expansion chamber;

f) a piercing tip configured to pierce a pressurized gas cartridge when actuated by a user; and

g) the vial spike is in fluid communication with the interior cavity of the expansion chamber and is configured to be in fluid communication with an injection device attached to the transfer device and a vial located within the vial lifter when the vial lifter is in the retracted position and the vial spike is located in the vial.

2. The transfer device of claim 1, further comprising a cartridge puncturing mechanism having a puncturing tip, the cartridge puncturing mechanism configured to puncture a pressurized gas cartridge with the puncturing tip when the cartridge puncturing mechanism is engaged by the vial lifter as the vial lifter moves toward the retracted position.

3. The transfer device of claim 2, wherein the puncture mechanism comprises a flexible wall having a first side and a second side, the puncture tip being located on the first side and a flexible wall camming ramp being located on the second side, and wherein the expansion chamber comprises an opening over which the flexible wall is located, wherein the puncture tip extends into the internal cavity, and wherein the vial lifter comprises a vial lifter camming ramp that engages the flexible wall camming ramp to move the puncture tip toward the pressurized gas cartridge when the vial lifter is moved toward the retracted position.

4. The transfer device of claim 1, wherein the vial elevator well comprises a well camming ramp and the vial elevator comprises a plurality of locking arms that move radially inward through the well camming ramp as the vial elevator moves toward the retracted position, each of the locking arms comprising a locking shoulder configured to engage a vial inserted into the vial elevator when the vial elevator is in the retracted position.

5. The transfer device of claim 4, wherein a plurality of radially extending locking tabs are included in the vial lifter, each of the locking tabs includes a locking post, and each of the locking arms includes a locking pawl that engages the locking tab to limit movement of the vial lifter toward the retracted position when the locking post is not engaged by a vial located in the vial lifter, and the locking tabs move to positions in which they are not engaged by the locking pawls as the vial lifter moves toward the retracted position when the locking post is engaged by a vial located in the vial lifter.

6. The transfer device of claim 5, wherein the vial lifter includes a vial spike opening that receives the vial spike when the vial lifter is in the retracted position, the vial spike configured such that the vial spike does not pass through the vial spike opening when the vial lifter locking pawl engages the locking tab.

7. The transfer device of any one of the preceding claims, wherein the vial elevator comprises a plurality of radially extending splines and the vial elevator well comprises a plurality of slots within which the splines slide as the vial elevator moves between the extended and retracted positions.

8. A transfer device according to any one of the preceding claims wherein the expansion chamber is in fluid communication with the vial spike via a transfer tube and the vial elevator well comprises a slot through which the transfer tube passes and wherein the vial elevator comprises a tube squeeze blade which presses the transfer tube against the vial elevator well and then releases the transfer tube when the vial elevator moves from the extended position to the retracted position.

9. The transfer device of any one of the preceding claims, wherein the vial spike comprises a liquid inlet and is mounted to a vial spike hub having a hub cavity in fluid communication with the liquid inlet of the vial spike and configured to be in fluid communication with an injection device attached to the transfer device, and the transfer device further comprises a semi-flexible gas tube extending through the vial spike, the semi-flexible gas tube being in fluid communication with the expansion chamber and having a gas outlet opening that is located above the liquid inlet of the vial spike when the vial spike is in the vial and the vial lifter is in the retracted position, the gas tube flexing in the hub cavity and retracting into the vial spike when the gas tube is in contact with the septum of the vial during insertion of the vial spike into the vial.

10. The transfer device of claim 9, wherein the gas tube is made of polyamide.

11. 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 positioned within the vial holder and configured to enter a vial containing a pharmaceutical fluid upon insertion of the vial into the vial holder;

c) an expansion chamber having an internal cavity in fluid communication with the vial spike and a pressure relief vent;

d) a pressurized gas cartridge positioned with the interior cavity of the expansion chamber;

e) a piercing tip configured to pierce a pressurized gas cartridge when actuated by a user;

f) the vial spike is configured to be in fluid communication with an injection device attached to a transfer device; and

g) a plunger rod slidably positioned within the pressure relief bore and configured to move between a closed position and a vented position.

12. The transfer device of claim 11, further comprising:

h) a compression spring urging the plunger rod in a first direction towards the interior cavity of the expansion chamber;

i) a retaining band configured to secure the injection device to the transfer device and having a first end attached to the transfer device and a second end removably attached to the plunger rod, thereby restricting movement of the plunger rod in a first direction.

13. The transfer device of claim 12 wherein the plunger rod includes a J-shaped slot within which the second end of the retention strap is received.

14. The transfer device of any one of claims 12 and 13, wherein the retention strap is configured to secure an injection device to the expansion chamber.

15. The transfer device of claim 14 further comprising a retaining ring mounted to the expansion chamber and configured to receive an injection device, and wherein the second end of the retaining band includes a hook that engages the retaining ring when the second end of the retaining band is attached to the plunger rod.

16. The transfer device of any one of the preceding claims further comprising an O-ring located on the plunger rod and engaging a sidewall of the pressure relief aperture when the plunger rod is in the closed position, the O-ring not engaging the pressure relief aperture when the plunger rod is in the venting position, thereby allowing pressurized gas in the internal chamber to vent through the pressure relief aperture.

17. 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 positioned 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 positioned within the interior cavity of the expansion chamber;

e) a piercing tip configured to pierce a pressurized gas cartridge when actuated by a user;

f) an exhaust gas filter, comprising:

i. a housing having a fluid inlet, a liquid outlet, and a gas outlet;

a hydrophilic membrane located in the housing and in fluid communication with the fluid inlet and the liquid outlet;

a hydrophobic membrane located in the housing and in fluid communication with the fluid inlet and the gas outlet; and

g) the vial spike is configured to provide the drug fluid from a vial inserted into the vial holder to the fluid inlet of the vent filter such that a liquid portion of the drug fluid flows through the hydrophilic member and out of the housing through a liquid outlet configured to be in fluid communication with an injection device attached to the transfer device, and a gas portion of the drug fluid flows through the hydrophobic membrane and out of the housing through a gas outlet.

18. The transfer device of claim 17, wherein a top portion of the expansion chamber includes a recess, the exhaust filter being located within the recess.

Technical Field

The present invention relates generally to devices for transferring fluids from vials (visas) to medical devices, and more particularly to pressurized gas powered devices and systems for transferring liquid drugs from source vials to injection devices and/or for mixing, diluting or reconstituting drugs and transferring the resulting liquid drug into injection devices.

Background

Injection devices that are worn by a patient temporarily or for extended periods of time are well known in the medical field. The subject matter of the present application relates to a transfer device, particularly but not exclusively for use with an injection device described in commonly assigned PCT published application number WO2014/204894, published 12-24, which is hereby incorporated by reference in its entirety. The injection device comprises an inner elastomeric bladder which may be filled with any suitable injectable medicament, whether a drug, antibiotic, biological or other injection, for subcutaneous injection (typically a bolus) into the patient when the device is worn by the patient.

The injection device must be filled (in whole or in part) with the desired injectant prior to injection into the patient. The above-mentioned PCT published application also discloses various transfer devices for transferring injectate from a source, such as one or more vials, into an injection device. In some cases, the injectate must be diluted or reconstituted, and various devices for accomplishing this are disclosed in the above-mentioned applications. The present application discloses additional novel designs and improvements to such transfer devices for transfer, dilution and/or reconstitution, allowing for lower manufacturing costs and less waste disposal. The transfer devices described herein may be variously referred to as transfer modules, accessories, or by other suitable terminology without intending any limitations on the structure or function of the devices not set forth herein.

Disclosure of Invention

Aspects of the present subject matter 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 together is not intended to exclude these aspects from use alone or from the claims set forth below either alone or in various combinations.

In one aspect, a transfer device for transferring a pharmaceutical fluid from a vial to a pharmaceutical fluid injection device comprises: a vial elevator configured to receive a vial containing a pharmaceutical fluid; and a vial elevator well within which the vial elevator moves between an extended position and a retracted position. The vial spike is positioned within the vial elevator well such that the vial spike is positioned within the vial when the vial elevator is in the retracted position. The expansion chamber has an internal cavity, and a pressurized gas cartridge is positioned with the internal cavity of the expansion chamber. The piercing tip is configured to pierce the pressurized gas cartridge when actuated by a user. The vial spike is in fluid communication with the interior cavity of the expansion chamber and is configured to be in fluid communication with an injection device attached to the transfer device and a vial located within the vial lifter when the vial lifter is in the retracted position and the vial spike is located in the vial.

In another aspect, a transfer device for transferring a pharmaceutical fluid from a vial to a pharmaceutical fluid injection device includes a vial holder, wherein a vial spike is positioned within the vial holder and is configured to enter a vial containing a pharmaceutical fluid upon insertion of the vial into the vial holder. The expansion chamber has an internal cavity in fluid communication with the vial spike and a pressure relief vent. A pressurized gas cartridge is positioned with the interior cavity of the expansion chamber. The piercing tip is configured to pierce 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. The plunger rod is slidably positioned within the pressure relief bore and is configured to move between a closed position and a vented position.

In yet another aspect, a transfer device for transferring a pharmaceutical fluid from a vial to a pharmaceutical fluid injection device comprises: a vial holder, wherein the vial spike is positioned within the vial holder and configured to enter a vial containing a pharmaceutical fluid upon insertion of the vial into the vial holder. The expansion chamber has an internal cavity in fluid communication with the vial spike. A pressurized gas cartridge is positioned within the interior cavity of the expansion chamber. The piercing tip is configured to pierce the pressurized gas cartridge when actuated by a user. The exhaust gas filter includes: a housing having a fluid inlet, a liquid outlet, and a gas outlet; a hydrophilic membrane located in the housing and in fluid communication with the fluid inlet and the liquid outlet; a hydrophobic membrane located in the housing and in fluid communication with the fluid inlet and the gas outlet. The vial spike is configured to provide the pharmaceutical fluid from a vial inserted into the vial holder to the fluid inlet of the vent filter such that the liquid portion of the pharmaceutical 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 gaseous portion of the drug fluid flows through the hydrophobic membrane and out of the housing through the gas outlet.

Drawings

FIG. 1 is a schematic view of a single vial pressurized gas power transfer system and an injection device.

Fig. 2 is a schematic diagram of a dual vial pressurized gas power transfer system and injection device.

Fig. 3A is a perspective view of an embodiment of the pressurized gas power transfer device of the present disclosure with an injection device attached.

Fig. 3B is a perspective view of the pressurized gas power transfer device of fig. 3A with the injection device removed.

Fig. 4 is an exploded view of the pressurized gas power transfer device of fig. 3A and 3B.

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 a raised or extended position.

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

FIG. 6 is a perspective view of the vial lifter of the vial holder of FIGS. 5A and 5B.

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

FIG. 8 is an enlarged perspective view of the stop tab, stop pin, locking arm and pawl of the vial lifter of FIGS. 5A-7 and the lifter well camming ramp of the vial lifter well of the vial holder.

FIG. 9 is an enlarged perspective view of a locking shoulder of the locking arm of the vial lifter of FIGS. 5A-8.

Fig. 10 is a first perspective view of the vial spike hub assembly of the injection device of fig. 3A-4.

Fig. 11 is a second perspective view of the vial spike hub assembly of the injection device of fig. 3A-4.

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 a vial.

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

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.

FIG. 13 is a cross-sectional view of the gas tube of the vial spike hub assembly of FIGS. 10 and 11 prior to crimping.

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

Fig. 15 is a first perspective view of the vial hub assembly and pressurized gas extension chamber of the transfer device of fig. 3A-4.

Fig. 16 is a second perspective view of the vial hub assembly and pressurized gas extension chamber of the transfer device of fig. 3A-4.

Fig. 17 is a perspective view of the chamber bottom of the pressurized gas expansion chamber of the transfer device of fig. 3A-4.

FIG. 18 is an enlarged perspective view showing the pressurized gas canister positioned with the chamber bottom of FIG. 17.

Fig. 19 is a top perspective view of the chamber top of the pressurized gas expansion chamber of the transfer device of fig. 3A-4.

Fig. 20 is a bottom perspective view of the chamber top of the pressurized gas expansion chamber of the transfer device of fig. 3A-4.

Fig. 21 is an enlarged cross-sectional view of the gas cartridge puncturing mechanism of the transfer device of fig. 3A-4.

Fig. 22 is a second cross-sectional view of the gas cartridge puncturing mechanism of the transfer device of fig. 3A-4.

Fig. 23 is an enlarged top plan view of the lifter and flexible wall camming ramp of the gas cartridge puncturing mechanism of fig. 21 and 22.

FIG. 24 is an enlarged cross-sectional view showing the lifter camming ramp of the vial lifter engaging the locking tab of the base plate.

FIG. 25 is an enlarged top view of the squeeze tube extension and paddle of the vial holder of the transfer device of FIGS. 3A-4.

Fig. 26A is an enlarged side view of the extruded tube blade of fig. 25 beginning to engage the transfer tube of the transfer device of fig. 3A-4.

Fig. 26B is an enlarged side view of the extruded tube blade of fig. 25 engaged with a transfer tube of the transfer device of fig. 3A-4.

Fig. 27 is a cross-sectional view of the exhaust filter of the transfer device of fig. 3A-4 taken along a vertical cutting plane.

Fig. 28 is a side view of a retaining band of the transfer device of fig. 3A-4.

Fig. 29 is an enlarged perspective view of an open hinge tab of the retaining ring of the transfer device of fig. 3A-4.

Fig. 30A is a cross-sectional view of the pressure relief assembly of the transfer device of fig. 3A-4 taken along a vertical cutting plane prior to use of the device and with an injection device attached.

Fig. 30B is a cross-sectional view of the pressure relief assembly of the transfer device of fig. 3A-4 taken along a vertical cutting plane during a first portion of a launch (fire) phase.

Fig. 30C is a cross-sectional view of the pressure relief assembly of the transfer device of fig. 3A-4 taken along a vertical cutting plane during a second portion of a launch stage.

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

Fig. 31 is an enlarged perspective view of the retaining ring of the transfer device of fig. 3A-4.

Fig. 32 is an enlarged view of a portion of the retaining ring of fig. 31 showing a mating post for retaining an injection device adhesive liner tab or safety band.

Detailed Description

As described in commonly assigned, previously published PCT application WO2016/154413, the entire contents of which are incorporated herein by reference, fig. 1 is a schematic diagram of a single vial transfer system that includes 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 cylinder may be any suitable cylinder commercially available or may be a custom cylinder. For example, a variety of possible gas cylinders may be used, with high pressure gas-filled disposable gas cylinders having a capacity of 1 to 1000 cc. The cylinder may be charged to a suitable pressure of up to 2000-. It should be understood that relatively small capacity disposable gas cylinders would be suitable for use in the present subject matter. For example, the cylinders can have a volume of 10ml or less, more preferably less than 5ml, such as 1-2ml, pressurized to 500psig or more, such as from 900psig up to 2000-.

The gas may be any suitable gas, such as, but not limited to, an inert gas. Since the gas will come into contact with the drug, the gas is preferably pathogen free, i.e. free of active pathogens. Nitrogen or argon may be suitable gases. When released from the gas cylinder, such as by puncture of a puncture needle, gas is directed through a suitable flow path from the gas 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.

The flow restrictor and/or the pressure regulator 101 may have any suitable configuration. By way of example only, in the embodiments of the present disclosure described below, the flow restrictor and pressure regulator may take the form of a chamber formed in the device within which the cartridge (cartridge) is located and to which the vial 102 and injection device 103 are attached. The flow path 104 directs gas from the restrictor/regulator to the vial 102. The flow restrictor/regulator may take the form of the filter described above.

The vial 102 may be a standard drug vial having a rigid container portion 105, typically glass, open at one end and sealed by a pierceable membrane or septum 106 of latex, silicone or other material. Preferably, the method is carried out with the vial in an inverted upright position such that gas flows to the closed end of the vial to force substantially all of the medicament from the vial under the force of the pressurized gas.

The flow path 107 directs the drug from the vial under pressure of a gas to a suitable container, such as the injection device 103, an example of which is described in commonly assigned, previously published PCT application number WO2014/204894, as previously described. The injection device may have a liquid reservoir, such as an expandable reservoir for containing the drug, e.g. a reservoir that expands under pressure from the drug. Once removed from the flow path 107, the reservoir may be biased to expel the drug when the user actuates the injection device. For example only, the syringe may have a capacity of 1-50 mL.

It should be noted that "injectate," "drug," "medicament," and similar terms are used interchangeably herein.

The lower surface 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 apparatus fill path 107 to transfer liquid to the injection device 103. The filling port 108 preferably comprises a check valve to prevent leakage of pressurized injection from the injection device 103 when the injection device is removed from the transfer apparatus and the filling port 108 is removed from the filling path 107.

The medicament is expelled from the injection device 103 via an injection cannula passing through the dispensing port 112.

For purposes of illustration and not limitation, fig. 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 dilution vial 122D, a drug vial 122M, and the injection device 103 of fig. 1. (each vial 122D and 122M may also contain a liquid drug). The cylinder 120 may be any suitable cylinder commercially available, as shown in fig. 1, or may be a custom cylinder.

Also similar to the single vial system, the gas may be any suitable gas, such as but not limited to an inert gas, which is preferably pathogen free, i.e. free of active pathogens. When released, such as by puncture of a puncture needle, gas is directed through a suitable flow path from the gas cylinder through a flow restrictor and/or pressure regulator 121 into dilution cylinder 122D. 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.

As in the system of fig. 1, the flow restrictor and/or pressure regulator 121 may have any suitable configuration, including a chamber formed in the device within which the cartridge is positioned and to which the vials 122D and 122M and injection device 103 are attached. A flow path 124 directs gas from the restrictor/regulator to the vial 122D. The flow restrictor/regulator may take the form of the filter described above.

The diluent (or first liquid drug) vial 122D and the drug (or second liquid drug) vial 122M may each be of standard drug vial configuration, having a rigid container portion, typically glass, open at one end and sealed by pierceable films or septa 126D and 126M of latex, silicone, or other material. Preferably, the method is carried out with the vial in an inverted upright position such that gas flows to the closed end of the vial to force substantially all of the diluent and/or drug out of the vial under the force of the pressurized gas before any gas exits the drug vial.

The flow path 127D directs the diluent (or liquid drug) from the diluent (or first liquid drug) vial 122D into the drug vial 122M under pressure of a gas, where the drug can be resuspended if in a dried lyophilized form, or can dilute the drug if in a liquid concentrated form (or can simply be combined or mixed with the drug if in a liquid non-concentrated form). The combined drug and diluent or diluted or mixed liquid drug flows under pressure of the gas from the drug vial 122M through the flow path 127M to any suitable container, such as the injection device 103 disclosed in the aforementioned PCT application.

An embodiment of the pressurized gas power transfer apparatus of the present disclosure is indicated generally at 140 in fig. 3A and 3B. The transfer device comprises two main parts: (1) a vial holder, generally indicated at 142, and (2) a gas expansion chamber, generally indicated at 144. Referring to fig. 3A and explained in more detail below, the injection device 103 may be docked to the expansion chamber 144 to receive the liquid medicament.

While the embodiments disclosed below use a single vial, alternative embodiments include a transfer station that can accommodate two or more vials in the manner shown in fig. 2.

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

The vial holder 142 includes a vial elevator well (e.g., generally indicated at 146 in FIGS. 4, 5A and 5B) within which is received a vial elevator 148. The vial elevator well 146 is secured to the base plate 150 (fig. 4) of the transfer device. The vial elevator 148 slides vertically within the vial elevator well 146 in a telescoping manner between an extended position shown in fig. 5A and a retracted position shown in fig. 5B.

As shown in FIG. 6, the vial lifter 148 includes a circular edge 152 with locking arms 154a-154d extending downwardly therefrom. In addition, splines 156a and 156b (also shown in fig. 7) extend downwardly from rim 152, as do actuating arms 158 of the pressurized cylinder puncturing mechanism. Stop tabs 162a-162d extend radially from the central base of the riser and each have a stop pin 164a-164 d. An opening 166 is formed in the center of the bottom of the vial lifter 148 and receives an upwardly directed vial spike mounted on the bottom of the base plate 150 (FIG. 4), as will be described in more detail below.

As shown in fig. 7, the vial elevator well 146 has a side wall 168 that includes inwardly facing channels 174a and 174b that slidingly receive the splines 156a and 156b of the vial elevator 148 to provide radial alignment of the vial elevator in the vial elevator well and to provide a smooth transition as the vial elevator moves.

As shown by locking arm 154a in FIG. 8, vial elevator well side wall 168 also has an inwardly extending camming ramp 170a (FIG. 8). Similar camming ramps are provided for locking arms 154b-154 d.

As further shown in fig. 8, the distal or lower end of the locking arm 154a includes a pawl 176a, while with reference to fig. 9, the upper portion of the locking arm 154a includes a vial locking shoulder 178 a. Locking arms 154b-154d have a similar configuration.

In operation, a vial in an inverted orientation (as shown for vial 102 in fig. 1) is lowered into the vial lifter 148 with the vial lifter in the extended position (fig. 5A) until a downward surface formed by the septum (106 of fig. 1) or edge of the vial engages the stop pins 164a-164d of the stop tabs 162a-162d (fig. 6). The user then gently presses the vial downward and the vial elevator 148 moves downward into the vial elevator well 146 toward the retracted position shown in fig. 5B.

As the vial lifter 146 moves downwardly toward the retracted position shown in FIG. 5B, the claws (170 a of FIG. 8) on the distal ends of the locking arms 154a-154d move inwardly as a result of the urging of the lifter well camming ramp (176 a of FIG. 8). As this occurs, the distal ends of the stop tabs 162a-162d of the vial lifter 148 are pushed downward as the downward facing end surfaces (septum and/or vial edge) of the vial push downward on the stop pins 164a-164 d. When the vial lifter 148 reaches the retracted position shown in fig. 5B, the vial locking shoulders (178 a of fig. 9) of the locking arms 154a-154d have moved to a position where they engage the neck (180 of fig. 1) of the vial 102. As a result, the vial is locked within the vial holder 142.

For example only, each vial may have a capacity of 1-50mL and a neck (neck finish) of 13-20 mm.

If a user attempts to push the vial lifter 148 of fig. 4-6 down into the vial lifter well 146 of fig. 4-5B without a vial in the vial lifter, the inward-facing pawls (176 a of fig. 8) on the distal ends of the locking arms 154a-154d will engage the distal ends of the stop tabs 162a-162d, as shown in fig. 8, to prevent the vial lifter 148 from moving into the retracted position of fig. 5B. The spacing between the bottom of the base plate (150 of FIG. 4) and the bottom of the vial lifter 148 is such that the tip of the vial spike on the bottom of the vial holder base is below the bottom of the vial lifter (i.e., the upwardly directed vial spike has not yet passed through the opening 166 in the bottom of the lifter) when the pawl of the locking arm engages the stop tab. As a result, the user is protected from pricking his fingers with the vial spike.

As previously described, and shown in FIGS. 4, 10 and 11, the vial spike 182 is mounted to the bottom of the base plate 150 by a vial spike hub 184. The vial spike has a tip that is directed through the vial membrane or septum (106 in fig. 1, 12B and 12C) and has two fluid paths-one allowing the entry of compressed gas to force liquid out of the vial and the other for expelling the liquid to the injection device.

As shown in fig. 4, 10 and 11, the 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 hubcap 198, the hubcap 198 being secured to the housing 192 to provide access to a cavity (202 of fig. 12A-12C) of the housing during assembly.

As shown in FIGS. 10-12C, the vial spike 182 may take the form of a cannula, preferably made of stainless steel, having a pointed tip 204 and liquid openings 206 and 208. A semi-flexible gas tube 212, preferably made of polyamide, has a gas outlet opening 214 and extends through the vial spike 182 and the chamber 202 of the vial spike hub and the gas inlet fitting 194. As will be explained in more detail below, the lower end of the gas tube 212 is selectively in fluid communication with a source of pressurized air or gas.

In order for gas entering from gas tube 212 to reach the headspace of a vial, such as vial 102 of fig. 12B and 12C, it should be able to pass through the vial spike liquid openings 206 and 208 and reach the top surface of the liquid drug in the vial. As a result, as shown in FIGS. 10 and 11, when pressurized gas is introduced into the vial, the gas tube opening 214 is generally positioned higher than the liquid openings 206 and 208 of the vial spike 182.

To prevent the gas tube 212 from flexing or being bent by the membrane or septum of the vial (106 of fig. 12B and 12C) as the vial spike 182 moves therethrough, the cavity 202 allows the gas tube 212 to flex within the vial spike hub housing 192. More specifically, referring to fig. 12A, prior to insertion of the vial spike 182 into the vial, the gas tube 212 is in a natural extended position with the gas outlet 214 located just below the pointed tip 214 of the vial spike 182.

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 by the septum down into the vial spike 182, where it is prevented from bending and flexing. The column strength of the gas tube 212 biases it to desirably remain straight when no external force is applied thereto. As shown in fig. 12B, these properties allow the gas tube 212 to flex downward in the cavity 202 of the vial spike hub housing 192 when a downward force is applied to the tip of the tube (the force applied by the vial septum 106 in fig. 12B). Because of the ability of the gas tube 212 to remain straight, the vial septum 106 springs back to its original extended position after its force has exited the top end of the gas tube 212 and has transferred to the vial spike 182 as the septum is seated on the vial spike, as shown in FIG. 12C.

After the vial spike and gas tube are fully seated within the vial, pressurized air is released into the vial headspace through the gas tube and gas tube opening. The tip of the gas tube (in its extended position) with the gas outlet opening is typically higher than the fluid outlet opening in the vial spike so that air bubbles through the liquid medicament and into the headspace or closed end of the vial.

An optional feature of the gas tube 212 that helps the gas to reach the top of the vial is the shape of the gas tube opening 214 at the tip of the gas tube. Instead of a circular opening shape (fig. 13), the gas tube 212 is squeezed at the tip, creating an elongated oval shape for the gas tube opening 214 (fig. 14). This shape acts as a restriction at the exit point of the tube, which in turn causes the gas to be released from the tube at a higher velocity, thereby preventing the gas from having the opportunity to be drawn into the liquid flow path of the vial spike. This concept is best described as being similar to a person placing a thumb/finger on the outlet to restrict water flow from the garden pipe-doing so increases the velocity of the fluid flow exiting the pipe.

When pressurized gas is introduced into the headspace of the vial, the liquid in the vial is forced out through the vial spike liquid outlets 206 and 208 of fig. 10 and 11. The liquid travels down into the chamber 202 (fig. 12A-12C) of the vial spike hub and out through the fluid outlet fitting 196 (fig. 10 and 11). The residual fluid in the subassembly should be minimized. To this end, the fluid outlet fitting 196 is positioned near the bottom of the cavity 202.

Referring to fig. 15 and 16, gas tube 212 passing through gas inlet fitting 194 (or cavity 202 only) of vial spike hub housing 192 is connected or spliced to flexible transfer tube 222. The opposite end of the transfer tube 222 is connected to a gas expansion chamber, generally indicated at 144, which serves as a source of pressurized gas for pressurizing the vials in the manner described above.

As shown in fig. 4, 15-17, gas expansion chamber 144 includes an expansion chamber top 226 and an expansion chamber bottom 228. As shown in fig. 15, the transfer tube 222 is connected to the pressurized gas supply port of the gas expansion chamber 144. As shown in fig. 4, the expansion chamber bottom 228 is received by the transfer device substrate 150.

Referring to fig. 17 and 18, expansion chamber bottom 228 defines an expansion chamber interior cavity 230 and is provided with a bracket 232 configured to hold and support a gas canister 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 may be used.

As shown in fig. 17 and 19, ribs 236 and 238 are formed on the bottom surfaces of the chamber top 226 and chamber bottom 228, respectively, and support the chamber to limit deflection or rupture. As shown in fig. 20, the top surface of the chamber top 226 is provided with a recess 242 for holding a filter through which fluid travels from the vial spike hub to an injection device mounted on the transfer device, as explained in more detail below.

Chamber posts 244 (fig. 17) on the edge of chamber bottom 228 align with openings formed in tabs 246 (fig. 19) that extend from chamber top 226 when assembled (also shown in fig. 4). The top and bottom of the chamber may then be glued together with an adhesive. The chamber post 244 also mates with a hex hole on the retaining ring, shown as 250 in fig. 4, so that it remains attached to the device. The X-post, indicated at 252 in fig. 17, allows for additional gluing surface and does not allow for large surface area of the chamber top 226 to flex when the internal cavity (230 of fig. 17) of the gas expansion chamber is pressurized. The flexible wall support (indicated at 254 in fig. 4) of the base plate 150 provides additional support for the gas expansion chamber sidewalls 256 (fig. 4 and 15-17) when the gas expansion chamber is pressurized.

When the gas cartridge 234 (fig. 4 and 18) located therein is pierced, the internal cavity 230 of the expansion chamber 144 is pressurized. A cartridge puncturing mechanism for doing so will now be described.

Referring to fig. 4, 15, 16, 21 and 22, flexible wall 260 has an inner surface that retains a piercing tip 264 having a sharp point and an outer surface that is provided with a flexible wall camming ramp 266. For example only, the flexible wall 160 may be made of plastic, having a thickness of about 0.030 "for flexibility.

Flexible wall 260 is positioned over an opening, indicated at 268 in fig. 17, 21 and 22, through which piercing tip 264 passes, as shown in fig. 21 and 22. The flexible wall is glued in place with an adhesive and then sandwiched between support ribs 274 (fig. 4, 21 and 22) formed on the base plate 150 after assembly of the transfer device. Referring to FIG. 4, the support rib 274 has a vertical slot 276 that receives the flexible wall camming ramp 266.

As previously described with reference to fig. 6, an actuating arm 158 extends downwardly from the edge 152 of the vial lifter 148. This is also shown in fig. 22. As shown in fig. 4, 6, 22 and 23, the distal end of the actuator arm 158 is provided with a lifter camming ramp 278.

When a vial is inserted into the vial lifter (148 of fig. 4-6) and pushed downward to retract the vial lifter into the vial lifter well (146 of fig. 4-5B), the actuation arm 158 of the vial lifter moves downward such that, referring to fig. 22 and 23, the lifter camming ramp 278 interacts with the flexible wall camming ramp 266 to force the central portion of the flexible wall 260, and thus the puncturing tip 264, to move inward and puncture the end of the pressurized gas cartridge 234 (also shown in fig. 18). In this way, the flexible wall is elastically deformed in a concave manner (when viewed from the outside of the gas expansion chamber 144). The flexible wall camming ramp 266 and the lifter camming ramp each preferably have a 20 degree angle (from vertical) to reduce the force and displacement required to bend and thus move the central portion of the flexible wall 260.

The shape and volume of the internal cavity 230 (fig. 17) of gas expansion chamber 144 is such that the pressure of the gas provided to transfer tube 222, and thus the vial spike hub and vial, is less than the pressure of the gas in gas cartridge 234 (fig. 18). As a result, the internal cavity 230 acts as a pressure regulator.

Referring to fig. 22, the elevator shaft wall 168 has a pin 282 that is received by an opening formed in the chamber top 226 such that the elevator shaft is connected to the expansion chamber, thereby restricting any movement from the top of the elevator shaft to help ensure puncturing of the gas cartridge.

The support ribs 274 of the base plate 150 limit the vertical movement of the flexible wall camming ramp 266, which helps eliminate any slack that would cause a misfire (misfire).

As shown in fig. 18 and 22, the angle at which piercing tip 264 engages pressurized gas cartridge 234 is preferably such that it forces the piercing tip into the corner of the cartridge piercing area, where the thinnest wall of the cartridge produces the least piercing load.

As shown in fig. 22 and 24, the base plate also has a lifter lock tab 284 that flexes as the vial lifter retracts into the vial lifter well and the vial lifter camming ramp 278 rides over it. The elevator lock tab 284 then curves back over the elevator camming ramp 278, as shown in fig. 24, to prevent removal of the vial from the vial elevator after transfer of the vial contents has begun.

The tube squeeze extension, indicated at 286 in fig. 5B, 7, 25, 26A and 26B, defines a slot 288 on the elevator well that serves as a holding location for the transfer tube 222 (fig. 15, 16, 26A and 26B) that extends between the pressurized gas expansion chamber and the gas tube of the vial spike hub.

The vial lifter includes a tube squeezing blade, indicated at 292 in fig. 6, 7, 25, 26A and 26B, having a sloped bottom surface, indicated at 294 in fig. 6 and 26A. The tube press blade 292 passes through a corresponding opening (295 of fig. 25) of the tube press extension.

As shown in fig. 26A and 26B, as the vial lifter and vial are moved downward to the retracted position in the vial lifter well, the tube squeeze blade 292 travels through the squeeze tube extension 286 and squeezes the transfer tube 222 against the edges of the slot 288 defining the squeeze tube extension until the vial lifter is in the fully retracted position (fig. 5B). One aspect of the system is the timing of the gas cylinder being pierced and gas being introduced into the vial. When the vial is inserted into the elevator and pushed to the end of the stroke, the elevator interacts with the flexible wall to pierce the gas canister. It is desirable that the vial spike is in the vial prior to flowing the pressurized gas into the vial. By squeezing the tube during travel of the elevator and puncturing of the gas canister, no pressurized gas flows into the vial until the vial spike is fully inserted into the vial (i.e., when the vial elevator is in the fully retracted position of fig. 5B). As shown in fig. 25, the crush blades 292 preferably have an arrow shape with the tip of the arrow (296 of fig. 25) crushing the tube and the arrow back plane against normal forces to crush the tube by abutting against the corresponding side of the opening 295.

Transfer tube 222 is preferably constructed of a tube that is sufficiently rigid so that it can be squeezed and released without disturbing the air flow. For example only, transfer tube 222 may be a PVC or other compatible tube having a 0.030 "inner diameter and a 0.060" outer diameter.

As previously explained, the liquid in the vial is forced by the pressurized gas out through the vial spike, vial spike hub cavity 202 (fig. 12A-12C) and out through the fluid outlet fitting 196 (fig. 15 and 16) of the vial spike hub. As shown in fig. 15 and 16 (and 3B), the fluid transfer line 290 directs fluid from the fluid outlet fitting 296 to an exhaust filter, indicated at 293 in fig. 3B, 15 and 16. A schematic of an exhaust gas filter is shown in fig. 27, wherein the exhaust gas filter is generally indicated at 293.

The vent filter is used to vent front and back air from the system during drug transfer to prevent air from entering the injection device. More specifically, as described above, the pressurized canister is punctured and serves as a driving force to push liquid and air from the vial. The empty fluid transfer line 290 between the vial spike hub and the vent filter 293 is filled with front air that should be expelled from the system before the liquid is pushed into the injection device.

Referring to fig. 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 of fig. 3A) is connected to receive liquid. The housing further comprises a hydrophilic membrane 315 and a hydrophobic membrane 317 between which a fluid chamber 319 is provided. The fluid chamber 319 receives fluid from the fluid transfer line 290. As a result, the front air trapped in the fluid path passes through the hydrophobic membrane 317, through the air outlet port 311 and into the atmosphere. The filtered liquid passes through the hydrophilic membrane 315 and enters the injection device through the liquid outlet portion 313.

The front air is vented due to the inherent flow restriction of hydrophilic membrane 315, plus the pressure required to fill the injection device. These factors force the front air to find the path of least resistance when sent through the vent filter 293, i.e. through the hydrophobic membrane 317 and through the air outlet port 311 rather than through the restricted hydrophilic membrane 315 and into the injection device. The hydrophilic membrane of the vent filter allows liquid to pass through it and into the injection device. Once the hydrophilic membrane is wetted with liquid, it will not allow air to pass through it, only the liquid, thereby preventing air from entering the injection device. The hydrophilic filter also has the ability to not only filter air but also prevent aggregates or particles from the drug product from migrating into the injection device.

Once all of the liquid is transferred into the injection device, residual air pressure is still present in the transfer device, including the expansion chamber. This air enters the filter and is blocked by the hydrophilic membrane 315 and is exhausted from the exhaust filter 293 to the atmosphere through the hydrophobic membrane 317. This process continues until a specified pressure is reached within the interior cavity of the gas expansion chamber and a pressure relief assembly, described below, releases the remaining pressure in the system.

The pore size of hydrophilic membrane 315 is preferably set by the pressure differential of the transfer system and the internal pressure of the injection device. If the pressure is higher than the exhaust filter 293 can handle, it will allow air to enter the injection device.

The liquid outlet port 313 may optionally receive a cannula to assist in filling the injection device. By way of example only, the cannula may be a 19 gauge needle having a curled tip to reduce the risk of damaging the filling septum of the injection device.

As previously noted with reference to fig. 20, the top surface of the chamber top 226 is provided with a recess 242 for retaining an exhaust filter 293 (shown in fig. 3B). This helps to reduce the overall height of the system.

Referring to fig. 3A, a retaining strap 301 retains the injection device 103 on the transfer device 140 during transport. Furthermore, the retaining strap 301 is intended to retain the latch during transfer of the drug from the vial to the injection device 103. Once all the medicament has been transferred to the injection device, the retaining band 301 is automatically released, indicating to the user that the injection device is ready to be placed on the body. In addition, a final venting from the transfer device is performed to release residual pressure inside the gas expansion chamber, which remains after the drug has been completely transferred to the injection device. This feature prevents the user from prematurely removing the injection device from the transfer base. Without the band, the user may be induced to remove the injection device before all of the medicament has been removed from the vial. The mechanism for performing these functions will now be described.

As shown in fig. 3A, 4 and 28, the retention strap 301 includes a first end having a D-shaped fastener 303 and a second end having a hook 305 and a pair of opposing latch pins 307. As shown in fig. 3B, 4 and 29, the retaining ring 250 is provided with a pair of open hinge tabs 309. As shown in fig. 3A, when the tape is used to secure an injection device to a transfer device, the hinge tab 309 engages the D-shaped fastener 303 of the retention tape 301. As will be explained in more detail below, the other end of the retainer strap (including the hook 305 and latch pin 307) is secured with a pressure relief assembly in the manner shown in fig. 3A.

As shown in fig. 4 and 17, the expansion chamber bottom 228 is provided with a pressure relief vent 302. As shown in fig. 30A-30D, a pressure relief assembly, generally indicated at 304, is located within the pressure relief vent 302. As shown in fig. 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 collars 314a and 314b between which the O-ring 310 is located, while the outer end of the plunger rod is provided with a J-shaped slot 316.

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

In addition, the hook 305 of the retainer strap is hooked to the shelf 324 on the retainer ring 250.

The configuration of the pressure relief assembly 304 during the launch phase is shown in fig. 30B. The launch phase is the phase in which the user pushes the vial into the vial lifter of the transfer device and moves it to the retracted position to activate the transfer device and transfer the drug from the vial into the injection device.

As described above, the act of pushing the vial into the system causes the pressurized gas cartridge (234 of fig. 18 and 22) to be pierced, thereby filling the internal cavity 230 of the pressurized gas expansion chamber 144 with pressurized gas. This pressure in the expansion chamber interior 230 urges the plunger rod 308 in the direction of arrow 326 against the urging of the compression spring 312. The plunger rod 308 is in a closed position in which the O-ring 310 reduces or eliminates leakage of pressurized gas from the internal cavity 230 of the expansion chamber 144. As a result, the pin 307 of the retention strap 301 moves toward the rounded bottom of the J-shaped slot 316 of the plunger rod 308, as shown in fig. 30B.

With continued reference to fig. 30B, the retainer strap 301 is molded (preferably of plastic) such that it has a biasing spring force inherent in the component that causes it to want to swing to the right (in the direction of arrow 328). As a result, when pin 307 is moved to the position shown in fig. 30B, hook 305 of retainer strap 301 is moved to the position shown in fig. 30C on shelf 324 of retainer ring 250, while pin 307 is moved in J-shaped slot 316 to the position shown in the figure.

At a time corresponding to fig. 30C, the transfer device is transferring fluid from the vial to the injection device and there is still gas pressure within the internal cavity 230 of the expansion chamber 144, which holds the plunger rod 308 in the position shown in fig. 30C, again against the urging of the compression spring 312. At the same time, as shown in fig. 30C, the latch pin 307 of the retention strap 301 contacts the wall of the J-shaped slot 316 of the plunger rod 308, which retains the hook 305 latched on the shelf 324 of the retention ring 250.

Once the transfer of fluid to the injection device is complete, the vent filter 293 (fig. 27) begins to vent the compressed air in the transfer device to the atmosphere. This allows the pressure in the internal cavity 230 of the expansion chamber 144 to decrease. As the pressure in the expansion chamber 144 decreases, the compression spring 312 begins to expand or expand (spring expansion is not shown) and the plunger rod 308 moves in the direction of arrow 322 of fig. 30A to the position shown in fig. 30D. As a result, the latch pin 307 of the retention strap 301 clears the open end of the J-shaped slot 316 of the plunger rod 308, causing the hook 305 of the retention strap 301 (due to the molded bias of the retention strap) to release the shelf 324 of the retention ring 250 and release the end of the retention strap, as shown in fig. 30D.

The characteristics of the compression spring 312 may be selected to retract at a particular pressure of the internal cavity 230 of the expansion chamber 144, thereby allowing the retention strap 301 to unlock at the particular pressure.

With continued reference to fig. 30D, the plunger rod 308 also acts as a final vent to relieve any additional pressure in the expansion chamber 144. This occurs when plunger rod 308 is in the vented position, once O-ring 310 passes through the "vented position" in vent hole 302 (as shown in fig. 30D), allowing the remaining compressed air to escape interior cavity 230 of expansion chamber 144 past the O-ring and the plunger rod.

Referring to fig. 31, wherein the retaining ring is shown removed from the transfer device and is generally indicated at 250, the front finger cut is indicated at 332 and the back finger cut is indicated at 334. The front finger cut-out 332 allows thumb placement for removal of the injection device when attached to the transfer device (as shown in fig. 3A), while the rear finger cut-out 334 allows multi-finger placement for removal of the injection device when attached to the transfer device.

Further, referring to fig. 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 the adhesive tabs 342 of the release liner. A 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 with the transfer device when the injection device is pulled out of the retaining ring 250 of the transfer device. Additionally, the mating posts 336 and 338 may be used to capture the distal end of a safety band attached to the injection device to prevent accidental activation of the injection device. The posts 336 and 338 hold the distal end of the safety belt so that when it is pulled out of the retaining ring 250 of the transfer device, the safety belt is automatically removed from the injection device and the injection device is thus ready to be activated to perform an injection.

Thus, the retaining ring 250 makes assembly of the injection device to the transfer device easier. It is not necessary to somehow plug the injection device safety band and release liner adhesive tab into the transfer device, but rather attaching the retaining ring 250 to the expansion chamber 144 is the final step of assembly and captures and thus mechanically locks to the adhesive liner and safety band.

Although the subject matter has been described herein with reference to particular structures, methods, and examples, this is for illustrative purposes only and it is to be understood that the subject matter is applicable to a wide range of devices and systems that may vary in particular configuration and appearance while still employing the subject matter.