Pressurized gas powered liquid transfer device and system

Abstract

A transfer device for transferring medical fluid from a vial to a medical fluid injection device includes a vial holder, wherein a vial needle positioned within the vial holder is configured to enter a vial containing medical fluid when the vial is inserted into the vial holder. An inflation chamber having an internal cavity is in fluid communication with the vial needle. A pressurized gas cartridge is positioned with the internal cavity of the inflation chamber, and a piercing tip is configured to pierce the pressurized gas cartridge when actuated by a user. The vial needle is also configured to be in fluid communication with an injection device attached to the transfer device.

Description

[0001] Priority Claim

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 060,924, filed August 4, 2020, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention generally relates to apparatus for transferring fluids from a vial to a medical device, and more particularly to pressurized gas-powered apparatuses and systems for transferring liquid drugs from a source vial to an injection device and / or for mixing, diluting or reconstituted drugs and transferring the resulting liquid drugs into the injection device. Background Technology

[0004] Injection devices worn temporarily or permanently by patients are well known in the medical field. The subject matter of this application relates to a transfer device, which is used particularly, but not exclusively, with the injection device described in co-assigned PCT Publication WO2014 / 204894, published on December 24, 2014, the entire contents of which are incorporated herein by reference. The injection device includes an internal elastic sac that can be filled with any suitable injectable drug, whether a pharmaceutical, antibiotic, biologic, or other injectable formulation, for subcutaneous injection, typically via a bolus injection, into a patient while the device is worn.

[0005] Before being injected into a patient, the injection device must be filled (fully or partially) with the required injectable solution. The aforementioned PCT publication also discloses various transfer devices for transferring injectable solutions from sources such as one or more vials into the injection device. In some cases, the injectable solution must be diluted or reconstituted, and various devices are disclosed in the aforementioned applications to achieve this. This application discloses further novel designs and improvements that allow for lower manufacturing costs and less waste to be disposed of for such transfer devices used for transfer, dilution, and / or reconstitution. The transfer devices described herein may be referred to differently as transfer modules, accessories, add-ons, or other suitable terms, without any limitation on the structure or function of devices not set forth herein. Summary of the Invention

[0006] Several aspects of this subject matter may be implemented individually 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 the individual use of these aspects or the individual claims to these aspects or the different combinations set forth in the appended claims.

[0007] In one aspect, a transfer device for transferring medical fluid from a vial to a medical fluid injection device includes a vial lifter and a vial lifter shaft configured to receive a vial containing medical fluid, the vial lifter being movable between an extended position and a retracted position within the vial lifter shaft. A vial needle is positioned within the vial lifter shaft such that when the vial lifter is in the retracted position, the vial needle is positioned within the vial. An expansion chamber is in fluid communication with the vial needle via a gas passage. An injection device port is in fluid communication with the vial needle via a liquid passage. A pressurized gas cylinder is positioned together with the expansion chamber. The transfer device also includes a puncture tip. A trigger spring has a hammer. The trigger spring is configured to be deflected and released when the vial lifter moves from the extended position to the retracted position. A flexible wall portion is positioned adjacent to the pressurized gas cylinder or the puncture tip and is configured to be engaged by the hammer of the trigger spring upon release of the trigger spring after deflection, such that the flexible wall portion causes the puncture tip to puncture the pressurized gas cylinder, thereby pressurizing the expansion chamber.

[0008] On the other hand, a method for transferring a liquid medication from a vial to an injection device includes the following steps: puncturing a pressure vessel with a puncture tip by using a deflected and then released trigger spring to provide relative movement between the pressure vessel and the puncture tip; depressurizing air from the punctured pressure vessel in an expansion chamber; and directing air from the expansion chamber to the vial to expel the liquid medication from the vial and direct the liquid medication from the vial to the injection device. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of a single-vial pressurized gas power transfer system and an injection device.

[0010] Figure 2 This is a schematic diagram of a dual-bottle pressurized gas transfer system and an injection device.

[0011] Figure 3 This is a perspective view of an embodiment of the pressurized gas dynamic transfer device of the present invention with an attached injection device.

[0012] Figure 4 The injection device has been removed. Figure 3 A perspective view of a pressurized gas power transfer device.

[0013] Figure 5A The casing cover has been removed. Figure 3 and 4 An enlarged perspective view of the vial holder of the transfer device.

[0014] Figure 5B The diagram shows the removal of the cam ring and the elevator shaft. Figure 5A Medicine bottle holder.

[0015] Figure 6A yes Figure 5A and5B An enlarged top view of the medicine bottle lifter.

[0016] Figure 6B yes Figure 6A A perspective view of the medicine bottle lifter.

[0017] Figure 7 yes Figure 5A An enlarged perspective view of the lifting shaft.

[0018] Figure 8 yes Figure 5A Enlarged perspective view of the cam ring.

[0019] Figure 9 This is a perspective view of an embodiment of the transfer device and the medicine bottle containing liquid medicine of the present invention.

[0020] Figure 10A yes Figure 3 Bottom perspective view of the transfer device.

[0021] Figure 10B The substrate has been removed. Figure 10A The transfer device.

[0022] Figure 11 yes Figure 3 and 4 A magnified transparent perspective view of the vial needle of the transfer device.

[0023] Figure 12 yes Figure 11 An alternative view.

[0024] Figure 13 yes Figure 4 A partially transparent cross-sectional view of the transfer device.

[0025] Figure 14A The casing cover has been removed. Figure 3 and 4 A perspective view of the transfer device.

[0026] Figure 14B The expansion chamber housing has been removed. Figure 14A The transfer device.

[0027] Figure 15 yes Figure 3 Alternate perspective view of the transfer device.

[0028] Figure 16 yes Figure 15 Enlarged perspective view of the retaining band.

[0029] Figure 17 yes Figure 3 , 4Enlarged perspective view of the decompression piston assembly, pivot plate, and part of the retaining belt of the transfer device of 15.

[0030] Figure 18 The casing cover has been removed. Figure 3 An enlarged perspective view of the transfer device.

[0031] Figure 19 It is the version with the pivot plate and decompression piston assembly removed. Figure 18 Enlarged perspective view of the ventilation housing and ventilation holes of the transfer device.

[0032] Figure 20 yes Figure 19 Bottom perspective view of the ventilation housing and ventilation holes.

[0033] Figure 21 yes Figure 3 , 4 Enlarged perspective view of the core of the pressure-reducing piston assembly of the transfer device of 15.

[0034] Figure 22 yes Figure 3 , 4 Enlarged perspective view of the sealing ring of the pressure reducing piston assembly of the transfer device of 15.

[0035] Figure 23 yes Figure 3 , 4 A perspective view of the decompression piston assembly of the transfer device of 15.

[0036] Figure 24 yes Figure 3 , 4 Enlarged top perspective view of the pivot plate of the transfer device of 15.

[0037] Figure 25 yes Figure 23 and 24 Top perspective view of the decompression piston assembly and pivot plate. Detailed Implementation

[0038] As described in the previously published PCT international application publication number WO2016 / 154413, which was jointly assigned and published on April 25, 2019 (which is incorporated herein by reference in its entirety), Figure 1This 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 medication vial 102, and an injection device 103. The gas cylinder can be any suitable commercially available cylinder or can be a custom-made cylinder. For example, various potential cylinders can be used with high-pressure filled disposable gas cylinders with capacities ranging from 1 to 1000 cc. The cylinder can be filled to a suitable pressure of 2000-3000 psig or higher. It should be understood that relatively small-capacity disposable gas cylinders will be suitable for this subject matter. For example, the cylinder can have a volume of 10 ml or less, more preferably less than 5 ml, such as 1-2 ml, pressurized to 500 psig or greater, such as from 900 psig to 2000-3000 psig or greater.

[0039] The gas can be any suitable gas, such as, but not limited to, inert gases. Since the gas will come into contact with the drug, it is preferably pathogen-free, i.e., free of active pathogens. Nitrogen or argon may be suitable gases. When released from the gas cylinder, for example by puncture with a needle, the gas is directed from the cylinder through a suitable flow path via a flow restrictor and / or pressure regulator 101 to the drug vial 102. Alternatively, the gas exiting the cylinder may be filtered through a filter with an pore size of 0.2 μm or smaller.

[0040] The flow restrictor and / or pressure regulator 101 can be any suitable configuration. By way of example only, in the embodiments disclosed below, the flow restrictor and pressure regulator can take the form of a chamber formed in a device to which the gas cartridge is located and to which the vial 102 and injection device 103 are attached. From the flow restrictor / regulator, flow path 104 directs the gas to the vial 102. The restrictor / regulator can take the form of the filter described above.

[0041] The vial 102 can be a standard vial with a rigid container portion 105, typically made of glass, open at one end and sealed by a puncture-resistant diaphragm or spacer 106 made of latex, silicone, or other materials. This method is preferably carried out with the vial in an inverted, upright position, allowing gas to flow towards the closed end of the vial, expelling substantially all of the medication from the vial under the force of the pressurized gas.

[0042] Flow path 107 guides the drug from the vial to a suitable container, such as injection device 103, under gas pressure, an example of which is described in the previously published PCT international application publication number WO2014 / 204894, which is jointly assigned. The injection device may have a liquid reservoir, such as an expandable reservoir for receiving the drug, for example, a reservoir that expands under pressure from the drug. Once the injection device is removed from flow path 107, the reservoir may be biased to expel the drug when the user actuates the injection device. By way of example only, the syringe capacity may be 1-50 ml.

[0043] It should be noted that the terms "injectable fluid", "injection", "drug", and "pharmaceutical" are used interchangeably in this article.

[0044] The lower surface of the injection device 103 may include a filling port 108 and a dispensing port 112. For example... Figure 1 As shown, the filling port 108 is an interface that allows the transfer device filling path 107 to transfer liquid to the injection device 103. The filling port 108 preferably includes a check valve to prevent leakage of pressurized injection from the injection device 103 when the injection device is removed from the transfer device and the filling port 108 is removed from the filling path 107.

[0045] The drug is dispensed from the injection device 103 through the injection cannula passing through the dispensing port 112.

[0046] For illustrative purposes and not for limitation, Figure 2 This is a schematic diagram of a pressurized gas-powered dual-vial resuspension and transfer system, which includes a pressure vessel in the form of a pre-filled pressurized gas cylinder or gas cartridge 120, a flow restrictor and / or pressure regulator 121, a liquid diluent vial 122D, and a drug vial 122M. Figure 1 Injection device 103. (Each vial 122D and 122M may also contain liquid medication). For example... Figure 1 As shown, gas cylinder 120 can be any suitable commercially available gas cylinder, or it can be a custom-made gas cylinder.

[0047] Similar to a single-vial system, the gas can be any suitable gas, such as, but not limited to, an inert gas, preferably free of pathogens, i.e., free of live pathogens. Upon release, for example by puncture with a needle, the gas is directed through a suitable flow path from the gas cylinder through a flow restrictor and / or pressure regulator 121 into the diluent vial 122D. Alternatively, the gas exiting the cylinder can be filtered through a filter with an pore size of 0.2 μm or smaller.

[0048] As in Figure 1As in the system, the flow restrictor and / or pressure regulator 121 can be any suitable configuration, including a chamber formed in a device in which the gas cartridge is located and vials 122D and 122M and injection device 103 are attached. From the flow restrictor / regulator, flow path 124 directs the gas to vial 122D. The restrictor / regulator can take the form of the filter described above.

[0049] The diluent (or first liquid drug) vial 122D and the drug (or second liquid drug) vial 122M can each be configured as a standard vial, having a rigid container portion, typically made of glass, open at one end and sealed by a puncture-resistant diaphragm or spacer 126D and 126M made of latex, silicone, or other materials. This method is preferably carried out with the vials in an inverted, upright position, allowing gas to flow towards the closed end of the vial, and expelling substantially all of the diluent and / or drug from the vial under the force of pressurized gas before any gas leaves the vial.

[0050] Flow path 127D guides the diluent (or liquid drug) from diluent (or first liquid drug) vial 122D to drug vial 122M under gas pressure. In drug vial 122M, if the drug is in dry or lyophilized form, it can be resuspended, or if the drug is in a concentrated liquid form, it can be diluted (or if the drug is in a non-concentrated liquid form, it can simply be combined or mixed with the drug). From drug vial 122M, the combined drug and diluent or diluted or mixed liquid drug flow under gas pressure through flow path 127M to any suitable container, such as the injection device 103 disclosed in the previously identified PCT application.

[0051] exist Figure 3 and 4 In this context, embodiments of the pressurized gas power transfer device of the present invention are generally indicated by 140. The transfer device includes a housing cover 136 and a base plate 138. Figure 5A , 5B (and 10A). The transfer device comprises two main parts: (1) a vial holder generally indicated by 142, and (2) a gas expansion section generally indicated by 144. Figure 3 As shown and explained in more detail below, the injection device 103 can dock with the gas expansion unit 144 to receive liquid medication.

[0052] Although the embodiments disclosed below use a single vial, alternative embodiments include those that can... Figure 2 The transfer station shown can accommodate two or more medicine bottles.

[0053] Furthermore, although the embodiments of the transfer device discussed below are single-use disposable devices, alternative embodiments include reusable transfer devices.

[0054] The vial holder 142 includes a vial lifter shaft, in Figure 3 and 4 The bottle lifter 148, generally designated 148, houses a bottle lifter shaft within the bottle lifter shaft 146. As described and shown in the commonly assigned PCT International Application Publication No. WO2019 / 079335 (the contents of which are incorporated herein by reference), the bottle lifter 148 slides vertically within the bottle lifter shaft 146 in a telescopic manner between a raised or extended position and a lowered or retracted position. In the raised or extended position, the bottle lifter 148 is in a telescopic position... Figure 3-5B As shown in Figure 9, in the lowered or retracted position, the medicine bottle lifter 148 is positioned downward within the medicine bottle lifter shaft 146.

[0055] like Figure 5A and 5B As shown, the housing cover has been removed, and the vial lifter shaft 146 is fixedly attached to the channel plate 190 of the transfer device. More specifically, the bottom of the vial lifter shaft 146 includes hooks (one of which is located at...). Figure 7 (shown as 139), the hook engages the rectangular ring structures 147a-147c of the channel plate 190 via a snap-fit ​​connection. Figure 5B ).

[0056] like Figure 5A , 5B As shown in 6A and 6B, the vial lifter 148 includes a circular edge 152 from which locking arms 154a-154d extend downward. The distal end of each locking arm 154a-154d is forked, such that each locking arm has a claw 155a-155d defining a notch 157a-157d. Furthermore, the upper portion of each locking arm 154a-154d includes a vial locking shoulder 178a-178d.

[0057] In addition, such as Figure 5A , 5B As further shown in 6A and 6B, splines 156a-156d extend downward from edge 152, each spline including an outwardly facing cam hook 158a-158d. Stop tabs 162a-162d extend radially from the central bottom of the elevator, and each has a stop pin 164a-164d. The distal ends of the stop tabs 162a-162d engage the distal ends of the pawls 155a-155d, thereby preventing inward movement of the pawls.

[0058] Opening 166 ( Figure 6A and 6B ) is formed at the center of the bottom of the medicine bottle lifter 148, and receives the material mounted on the channel plate 190. Figure 5A and 5B The needle of the vial points upwards, which will be explained in more detail below.

[0059] like Figure 7 As shown, the vial lift shaft is shown separately and generally designated as 146. The vial lift shaft has a sidewall 168 that includes inwardly facing channels 174a-174d that slidably receive splines 156a and 156b of the vial lift 148 to provide radial alignment of the vial lift shaft and to provide a smooth transition as the vial lift moves.

[0060] Similarly, Figure 7 As shown, the inner surface of the sidewall 168 includes inwardly extending cam ramps 170a-170d.

[0061] exist Figure 5A and Figure 8 The cam ring, generally designated 182, includes sidewalls 184 having notches and a central opening 188. Each notch includes an edge that defines cam surfaces 186a-186d.

[0062] like Figure 5A As shown, the central opening of the cam ring 182 is sized to accommodate the vial lifter shaft 146, allowing the cam ring to be rotatably positioned on the channel plate 190. Figure 5A As shown, when the medicine bottle lifter is in the raised or extended position, the hook 158a of spline 156a is located on top of the cam surface 186a of the cam ring 182. The hooks 158b-158d of splines 156b-156d are in the same position relative to the cam surfaces 186b-186d.

[0063] During operation, when the medicine bottle lifter is in the raised or extended position ( Figure 3-5B When, such as Figure 9 As shown in the image, medicine bottle 153, in an inverted position, is placed into medicine bottle lifter 148 until the downward surface formed by the diaphragm or edge of the medicine bottle aligns with the stop pins 164a-164d of the stop tabs 162a-162d. Figures 5A-6B The bottle is then engaged. The user then gently presses down on the bottle. When this occurs, the distal ends of the stop tabs 162a-162d of the bottle lifter 148 are pushed downwards as the downward-facing end face of the bottle (diaphragm and / or bottle edge) pushes downwards on the stop pins 164a-164d. As a result, the claws 155a-155d of the locking arms 154a-154d can move freely inwards.

[0064] As the user continues to press down on the medicine bottle, the medicine bottle lifter 148 moves downward toward the retracted position (along...). Figure 5A (In the direction of arrow 169) enter the stationary medicine bottle lift shaft 146.

[0065] As the vial lifter 146 moves downward toward the retracted position, due to the inclined surface of the lifter shaft cam ( Figure 7 The push of the 170a-170d locks the claw on the distal end of the 154a-154d. Figure 6A and 6B 155a-155b) moves inward. When the bottle lifter 148 reaches the fully retracted position, the bottle locking shoulder of the locking arms 154a-154d ( Figures 5A-6B The cam hooks 178a-178d have been moved to their positions engaging the bottle neck. Furthermore, each cam hook 158a-158d (Figs. 5a-6B) has engaged a corresponding rectangular lifter locking ring, such as lifter locking rings 182a and 182b illustrated for cam hooks 158a and 158b. As a result, the bottle lifter 148 is locked in the lowered or retracted position, and the bottle is locked within the bottle holder 142.

[0066] For example only, each vial may have a capacity of 1-50 ml and a neck diameter of 13-20 mm.

[0067] As previously stated, if a user attempts to push the bottle lifter 148 downwards into the bottle lifter shaft 146, and there is no bottle in the bottle lifter, the inward movement of the pawls 155a-155d on the distal ends of the locking arms 154a-154d is prevented due to engagement with the distal ends of the stop tabs 162a-162d, thereby preventing the bottle lifter 148 from moving to the retracted position. (Channel plate) Figure 5A and 5B The distance between the bottom of the vial holder 190 and the bottom of the vial lifter 148 is such that when the pawl of the locking arm engages with the stop tab, the tip of the vial needle located at the bottom of the vial holder base is below the bottom of the vial lifter (i.e., the upward-pointing vial needle has not yet passed through the opening 166 at the bottom of the lifter). As a result, the user's finger is prevented from being pricked by the vial needle.

[0068] like Figure 10A As shown, the substrate 138 covers the bottom of the housing 136 of the transfer device 140. Figure 10B As shown, the removal of the substrate exposes the channel plate (generally indicated by 190) and the gas expansion chamber 194, which serves as a pressurized gas source for pressurizing the vial, as described below.

[0069] like Figure 10B As shown, the gas expansion chamber 194 is provided with a support 202, which is configured to hold and support the gas cylinder 204 containing compressed gas (e.g., compressed nitrogen). Figure 10B(Seen in transparent form). Of course, cylinders containing other types of compressed or pressurized gas can be used. As will be explained in more detail below, the gas cylinder is punctured to provide pressurized air, thereby forcing the liquid from the vial ( Figure 9 153) is driven to the injection device connected to the transfer device 140. Figure 3 (103 in the middle).

[0070] The channel plate 190 is provided with a filter recess 206 for holding the filter 208, as explained in more detail below, through which fluid travels from the vial needle interface to the injection device mounted on the transfer device.

[0071] Similar to liquid channel 214, gas channel 212 is formed in channel plate 190. By way of example only, the channel plate may be formed of plastic, in which the channels are cut, molded, or otherwise formed. The inlet of gas channel 212 is in fluid communication with gas expansion chamber 194, while the outlet of liquid channel 214 is in fluid communication with filter recess 206.

[0072] Integrating the gas and liquid channels 212 and 214 into the channel plate offers advantages in terms of manufacturing efficiency and shorter channel length. The latter reduces the pressure drop of the fluid flowing through the channel, thus allowing the use of lower-pressure gas cylinders. This structure also facilitates the scalability of the transfer device. By way of example only, the base plate, housing cover, channel plate, and other components of the transfer device can be made of plastic and fixed together by laser bonding, ultrasonic welding, or adhesives.

[0073] like Figure 11 and 12 As shown, the inlet of the liquid channel 214 is in fluid communication with the lower end of the vial needle, generally indicated by 216, via a conduit 218. The conduit 218 is located within... Figure 5B and 11 Within the boss shown at 219, the boss is formed on the top surface of the channel plate 190 and is located within the medicine bottle lifter ( Figure 5A and 5B Below the central portion of (148). The vial needle 216 is secured to the hole in the boss 219 by adhesive to prevent fluid "short-circuiting" relative to the gas passage 212. The vial needle 216 may be in the form of a sleeve, preferably made of stainless steel, with a tip forming a liquid opening 220.

[0074] The gas tube 222 has a gas outlet opening 224 and extends through the vial needle 216. The lower end of the gas tube 222 is fixed within the channel plate 190 and is in fluid communication with the outlet of the gas channel 212. By way of example only, the gas tube may be made of polyamide.

[0075] In order for the incoming gas from gas tube 222 to reach the top space of the vial locked within the device as described above, it should be able to pass through the liquid opening 220 of the vial needle and reach the top surface of the liquid medication in the vial. As a result, as Figure 11 As shown, the gas tube opening 224 is positioned above the liquid opening 220 of the vial needle 216.

[0076] In an alternative embodiment, two separate needles with independent lumens can be used as vial needles and gas tubes.

[0077] when Figures 5A-6B When the vial lifter 148 moves to the lowered and retracted position (whereby the vial needle passes through the central opening 166 of the vial lifter), the tip of the vial needle 216 passes through the vial diaphragm or septum. The vial needle 216 and the gas tube 222 provide two fluid paths—one allowing compressed gas to enter to expel liquid from the vial, and the other for discharging liquid into the injection device.

[0078] After the needle and gas tube are fully positioned inside the vial, compressed gas from the punctured compressed gas cylinder 204 and gas expansion chamber 194... Figure 10B Then the pressurized air in gas path 212 is released into the top space of the vial through gas tube 222 and gas tube opening 224. The tip of gas tube 222, which has gas outlet opening 224, is typically higher than the fluid outlet opening 220 in vial needle 216, thereby allowing air to bubble upward through the liquid drug and enter the top space or closed end of the vial.

[0079] The liquid medicine in the vial is propelled by pressurized gas to leave through the vial needle opening 220 and the conduit 218, and flows out through the liquid channel 214 to the lower part or the inlet side of the ventilation recess 206.

[0080] Reference Figure 13 The housing 136 of the transfer device 140 includes an injection device support surface 227. An injection device port, such as a transfer sleeve 229, passes through the injection device support surface 227. The tip portion of the transfer sleeve 229 enters the filling port of the injection device located on the injection device support surface (e.g., ...). Figure 3 (As shown in injection device 103). The bottom portion of transfer sleeve 229 is in fluid communication with the upper side or outlet side of filter recess 206. By way of example only, the transfer sleeve may be a 19-gauge tube with rounded edges, which reduces the risk of damaging the filling diaphragm of the injection device.

[0081] Continue to refer to Figure 13Ventilation filter 208 is used to vent air from the front and rear ends of the system during drug transfer, preventing air from entering the injection device. More specifically, as described above, the pressure vessel is punctured and used as the driving force to expel liquid and air from the vial. The empty liquid passage 214 between the vial needle 216 and the filter recess (and filter 208) is filled with front-end air, which should be vented from the system before liquid can be pushed into the injection device.

[0082] Reference Figure 10A The filter recess is provided with an air outlet 231, which is formed in the filter recess cover 233. As explained in PCT International Application Publication No. WO2016 / 154413 (incorporated above by reference), filter 208 ( Figure 13 The filter 208 comprises a hydrophilic membrane and a hydrophobic membrane, with a fluid chamber located therebetween. The filter recess 206 receives fluid from the liquid channel 214. As a result, the air trapped in the fluid path passes through the hydrophobic membrane of the filter 208 and flows out from the air outlet port 231 into the atmosphere. The filtered liquid passes through the hydrophilic membrane of the filter 208, flows out through the transfer sleeve 229, and enters the injection device.

[0083] Due to the inherent flow restriction of the hydrophilic membrane, coupled with the pressure required for filling the injection device, air at the front end is expelled. These factors force the air at the front end to find the path of least resistance when passing through filter 208, namely through the hydrophobic membrane and air outlet port 231. Figure 10A Instead of passing through a restrictive hydrophilic membrane and entering the injection device, the fluid passes through the hydrophilic membrane of the venting filter and enters the injection device. Once the hydrophilic membrane is wetted by the fluid, it will not allow air to pass through, allowing only the fluid to pass through, thus preventing air from entering the injection device. The hydrophilic filter is also capable of filtering not only air but also aggregates or particles that have migrated from the drug product into the injection device.

[0084] Once all the liquid has been transferred to the injection device, residual air pressure remains in the transfer device, including in the gas expansion chamber 194. This air enters the filter 208, is blocked by the hydrophilic membrane, and exits through the hydrophobic membrane into the atmosphere via the filter recess 206. This process continues until the specified pressure is reached in the gas expansion chamber, and as described below, the pressure-reducing assembly releases the remaining pressure in the system.

[0085] As mentioned earlier, when the gas cylinder 204 located therein ( Figure 10B When punctured, the gas expansion chamber 194 is pressurized. The gas cylinder puncture mechanism used to do this will now be described.

[0086] Reference Figure 14AThe gas expansion chamber housing 234 includes a flexible wall portion 236. By way of example only, the flexible wall portion 236 may be made of plastic with a thickness of approximately 0.030” to achieve flexibility.

[0087] The trigger spring, generally designated 238, includes a distal hammer portion 242 and a latch portion 243, and a proximal multi-bend retaining portion 244. A bracket 246 formed on the channel plate 190 and a retaining post 248 cooperate to securely hold the proximal retaining portion of the trigger spring in place. The hammer portion 242 is pushed by the spring force of the trigger spring and engages with the flexible wall portion 236 of the gas expansion chamber housing 234, as... Figure 14A As shown. For example only, the trigger spring 238 can be made of metal or steel.

[0088] Continue to refer to Figure 14A The connecting rod 252 includes a first recess 254 and a second recess 256. The first recess 254 is engaged by a latch portion 243 on the distal end of a trigger spring 238. The second recess 256 is engaged by a connecting rod hook 258 formed on or fixed to the cam ring 182. By way of example only, the connecting rod may be made of steel, metal, or plastic.

[0089] like Figure 14B As shown, the gas cylinder cap 262 has an inner surface that holds the puncture tip, indicated by dashed line 264, which has a pointed tip. The cap 262 holds the puncture tip 264 in a position opposite to the seal of the pressurized gas cylinder 204.

[0090] For example, through comparison Figure 14A and 14B As shown, the cap 262 is positioned adjacent to and engages with the inner surface of the flexible wall portion 236 at a position corresponding to the engagement position of the hammer portion 242 of the trigger spring with the flexible wall portion. As a result, the flexible wall portion 236 is sandwiched between the pressurized gas canister cap 262 and the hammer portion 242 of the trigger spring 238.

[0091] As mentioned above, Figure 14B As shown, when the medicine bottle lifter is in the raised or extended position, the cam hook 158a of spline 156a is located on the top of the cam surface 186a of the cam ring 182, and the cam hook 158d of spline 156d is located on the top of the cam surface 186d. The cam hooks 158b and 158c of splines 156b and 156c (… Figure 6A and 6B ) relative to cam surfaces 186b and 186c ( Figure 8 They are in the same position.

[0092] When the medicine bottle is inserted into the medicine bottle lifter ( Figure 4In -6 of 148), and is pushed downward, causing the medicine bottle lifter 148 to lower and retract into the medicine bottle lifter shaft 146, the spline hooks 158a-158d of the medicine bottle lifter move downward along the corresponding cam surfaces 186a-186d of the cam ring, causing the cam ring along Figure 14A and 14B Rotate in the direction of arrow 270 (i.e., counterclockwise).

[0093] When the cam ring rotates in the direction of arrow 270 ( Figure 14B The connecting rod 252 is along the hook 258 of the cam ring 182. Figure 14A and 14B The trigger spring is pulled in the direction of arrow 272. As a result, the hammer 242 of the trigger spring is pulled away from the flexible wall 236 of the gas expansion chamber housing against the push of the trigger spring. This happens until the latch 243 of the trigger spring slides out of the first notch 254 of the connecting rod 252, so that the deflecting hammer 242, now spaced apart from the flexible wall 236, is released.

[0094] Due to the elastic force acting on the deflecting trigger spring, the released hammer 242 impacts the flexible wall portion as it springs back to its initial position. This forces the central region of the flexible wall portion 236 and... Figure 14B The puncture tip 264 moves inward and punctures the seal of the pressurized gas cylinder 204. In doing so, the flexible wall elastically deforms in a concave manner (when viewed from the outside of the gas expansion chamber housing 234). As a result, pressurized gas from the gas cylinder fills the gas expansion chamber and flows via the gas passage 212 to the gas pipe 222. Figure 11 As mentioned above.

[0095] It should be noted that, in alternative embodiments, a flexible wall may be used to push the gas cylinder toward a fixed puncture tip to puncture the seal of the pressurized gas cylinder.

[0096] Gas expansion chamber 194 ( Figure 10B The shape and volume of ) allow gas to be supplied to gas pipe 222 via gas channel 212. Figure 11 Therefore, the gas pressure supplied to the medicine bottle located in the lowered or retracted medicine bottle lifter is less than that of the gas cylinder 204. Figure 14B The gas pressure in the cavity 194 is thus controlled. As a result, the cavity 194 acts as a pressure regulator.

[0097] Reference Figure 14AThe tuning pin 276 is optionally disposed on the channel plate 190 and is engaged by the side of the connecting rod 252 when it is pulled by the hook 258 of the cam ring 182 in the manner described above. As a result, when the connecting rod moves, the tuning pin deflects the connecting rod 252, which is preferably elastic, and thus affects the release of the latch portion 243 of the trigger spring through the notch 254. Therefore, the positioning of the tuning pin 276 can be adjusted to fine-tune the release point of the trigger spring hammer portion 242 by retracting it into the bottle lifter shaft 146 relative to the bottle lifter 148 (and the bottle thus positioned therein).

[0098] like Figure 3 and 15 As shown, during transport, a retaining strap, generally indicated by 300, holds the injection device 103 onto the transfer device 140. Furthermore, as described below, the retaining strap 300 maintains a latch during the transfer of medication from the vial to the injection device 103. Once all medication has been transferred to the injection device, the retaining strap 300 is automatically released, indicating to the user that the injection device is ready to be placed on the body.

[0099] In addition, final venting is performed from the transfer device 140, which releases gas from the expansion chamber 194. Figure 10B The residual pressure within the vial persists even after the medication has been completely transferred to the injection device 103. This feature prevents the user from prematurely removing the injection device from the transfer base. Without it, the user might remove the injection device before all the medication has been transferred from the vial. The mechanisms that perform these functions will now be described.

[0100] like Figure 16 As shown, the retaining band 300 includes a first end 301 having a pair of hinge pins 303 and a second end 302 having a latch hook 305. Figure 15 As shown, the hinge pin 303 is housed within the hinge pin socket 308, allowing the hinge pin 303 to rotate freely therein. For illustrative purposes only, the hinge pin can also be secured within the hinge pin socket by a snap-fit ​​mechanism.

[0101] like Figure 17 As shown, the latch hook at the second end 302 is fixed to the pivot plate 308. Figure 3 and 15 The latch position is shown. As described below, during the process of releasing air pressure from the transfer device, the pivot plate 308 moves from... Figure 17 Pivot at the position shown in the direction of arrow 312 (i.e., counterclockwise) to release the latch hook 305 holding the band 300. Figure 16 This allows the injection device to be removed from the transfer device for use.

[0102] like Figure 10B and 18As shown, the expansion chamber 194 is provided with a ventilation housing 320. The ventilation housing includes... Figure 10B , 19 And the pressure relief or ventilation hole indicated by 322 in 20.

[0103] like Figure 14A and 17 As shown, the pressure-reducing piston assembly, generally indicated by 324, is positioned within the pressure-reducing port of the vent housing 320. The pressure-reducing piston assembly includes... Figure 21 The core, generally designated 330, has a head 332 (also...). Figure 14A , 18 (shown in 23 and 25) and flange 334. See reference... Figure 21 The head 332 includes a pair of ear plates 336a and 336b, shoulders 338a and 338b, and a stop 342. (See reference...) Figure 22 and 23 The sealing ring 344 is attached to the bottom of the core below the flange 334. For example... Figure 14B and 23 As shown, the compression coil spring 346 is also located around the core above the flange 334.

[0104] The pressure-reducing piston assembly 324 is inserted forward through the bottom opening of the hole 322 (in) Figure 20 (visible in the middle) and make ear plates 336a and 336b ( Figure 21 ) pass upwards Figure 19 The corresponding portion of the cross-shaped top opening 348 of the ventilation housing is attached to the ventilation housing 320. As a result, see reference... Figure 23 The compression coil spring 346, flange 334, and sealing ring are all located inside the holes of the ventilation housing.

[0105] like Figure 14A and 18 As shown, the aforementioned pivot plate 308 is pivotally attached to the mounting post 352, which is positioned near the ventilation housing 320. A torsion spring 354 is also positioned on the mounting post 352 and pushes the pivot plate 308 counterclockwise. Figure 25 The arrow in the diagram (374) rotates. For example... Figure 24 As shown, the pivot plate includes an arcuate main slot 356 with a stop wall 358, a pair of opposing recesses 362a and 362b, and a pair of opposing slots 364a and 364b.

[0106] like Figure 14A and 18 As shown, the arc-shaped main slot 356 covers the top of the vent housing 320, similarly... Figure 25 As shown, due to Figure 23Driven by the compression of the helical spring 346, the head 332 of the piston assembly is located within the elongated slot 356, and the arms 336a and 336b of the piston assembly are initially located within the recesses 362a and 362b of the pivot plate 308. Figure 10B As shown, when the depressurization assembly is in this configuration (which corresponds to the transfer device before the pressurized gas cylinder in the expansion chamber is punctured), the sealing ring 344 is located inside the vent 322 and closes the vent 322.

[0107] Figure 3 and 15 The diagram shows a transfer device 140 before use, on which an injection device 103 is positioned and secured to it by a retaining band 300. Figure 14A , 18 23 and 25 show the corresponding Figure 3 and 15 The arrangement of the decompression piston assembly 324 and the pivot plate in the initial state of the transfer device is shown.

[0108] The user then inserts and pushes the vial containing the liquid medication into the vial lifter of the transfer device, and moves it to the retracted position, thereby activating the transfer device and beginning to transfer the medication from the vial into the injection device.

[0109] As described above, the action of pushing the medicine bottle into the system causes the pressurized gas cylinder ( Figure 10B and 14B 204) was punctured, thereby filling the pressurized gas expansion chamber 194 with pressurized gas. Figure 10B The pressure in the gas expansion chamber pushes the bottom of the sealing ring 344. Figure 10B and 23 This forces the piston assembly to overcome the push of the piston assembly compression spring 346 and move along... Figure 23 Arrow 372 points upwards. As a result, refer to... Figure 25 The piston assembly arms 336a and 336b emerge from the recesses 362a and 362b of the pivot plate 308. Figure 24 The pivot plate 308 rises from the center due to the torsion spring 354. Figure 14A and 18 Driven by ) along Figure 25 Rotate in the direction of arrow 374 until the stop 342 of the piston assembly contacts the stop wall 358 of the pivot plate 308. At this time, the sealing ring 344 remains within the vent 322, and the vent remains closed when liquid medication is transferred from the vial to the injection device. Furthermore, refer to... Figure 17 The retaining band 300 is engaged with the pivot plate 308, such that the retaining band prevents the injection device from being removed from the transfer device during the transfer of liquid medication.

[0110] Once the transfer of fluid to the injection device is complete, the ventilation filter 208 ( Figure 10B and 13 ) Start by transferring compressed air from the liquid path 214 of the transfer device ( Figure 12 This allows the expansion chamber 194 ( ) to be released into the atmosphere. Figure 10B and 13 The pressure in the expansion chamber decreases. As the pressure in the expansion chamber decreases, the compression spring 346 ( Figure 14B and 23 It begins to expand or extend, and refers to Figure 10B The sealing ring 344 of the pressure-reducing piston assembly moves downward within the ventilation hole 322 of the ventilation housing 320. Figure 10B and 20 A ventilation notch, indicated by 382, ​​is formed in the ventilation housing 320. When the sealing ring 344 descends below the notch, compressed air from the expansion chamber 194 bypasses the sealing ring and enters the ventilation port 322. This causes the sealing ring 344 to move further downwards into the expansion chamber, allowing the remaining pressurized air in the expansion chamber to be rapidly discharged through the ventilation port 322 during the final ventilation stage, and through the ventilation port 384 formed in the injection device support surface 227. Figure 4 It is released into the atmosphere.

[0111] After the final ventilation phase, expansion chamber 194 ( Figure 10B The pressure inside is at atmospheric pressure, so there is no longer any pressure pushing upwards to the bottom of the sealing ring 344 of the pressure-reducing piston assembly. As a result, the compression spring 346 ( Figure 14B and 23 The piston extends further freely, and the piston head falls downward relative to the pivot plate 308. When this occurs, the stop 342 ( Figure 23 and 25 Slide downwards and away from the pivot plate stop surface. Figure 23-25 (358). As the compression spring extends further, piston arms 336a and 336b then pass through Figure 24 and 25 The relative slots 364a and 364b fall and leave the pivot plate 308. As the piston arms 336a and 336b leave the pivot plate 308, due to the torsion spring 354 ( Figure 14A and 18 Driven by ), the pivot plate further along Figure 25 Arrow 374 or Figure 17 Rotate in the direction of arrow 312 (counterclockwise). As a result, refer to... Figure 17 Pivoting plate 308 pivots away from the latch hook of retaining band 300. Figure 16 (305), causing the belt to be released. Then, the belt 300 is held in place by pin 303 on the opposite end ( Figure 16The pivoting mechanism allows the injection device to be removed from the transfer device for patient use.

[0112] Although this topic is described herein with reference to specific structures, methods and examples, this is for illustrative purposes only, and it should be understood that this topic can be applied to a wide range of devices and systems that may differ in specific configurations and appearances, while still employing this topic.

Claims

1. A transfer device for transferring medical fluid from a vial to a medical fluid injection device, comprising: a) A medicine bottle lifter configured to receive medicine bottles containing medical fluid; b) A bottle lifter shaft, within which the bottle lifter moves between an extended position and a retracted position; c) The vial needle is positioned inside the vial lifter shaft so that when the vial lifter is in the retracted position, the vial needle is positioned inside the vial. d) Expansion chamber, which is in fluid communication with the vial needle via a gas passage; e) The injection device port is in fluid communication with the vial needle via a liquid channel; f) A pressurized gas cylinder positioned together with the expansion chamber; g) Puncture tip; h) A trigger spring with a hammer, the trigger spring being deflected and released when the vial lifter moves from the extended position to the retracted position; as well as i) A flexible wall portion positioned adjacent to the pressurized gas cylinder or the puncture tip, and configured to engage with the hammer of the trigger spring upon release of the trigger spring after deflection, such that the flexible wall portion causes the puncture tip to puncture the pressurized gas cylinder, thereby pressurizing the expansion chamber.

2. The transfer device according to claim 1, further comprising a channel plate, wherein the gas and liquid channels are formed in the channel plate.

3. The transfer device according to claim 2, wherein, The gas and liquid channels are cut into the channel plate.

4. The transfer device according to claim 2, wherein, The gas and liquid channels are molded into the channel plate.

5. The transfer device according to claim 1, further comprising a ventilated filter positioned in the circuit having the liquid passage.

6. The transfer device according to claim 1, wherein, The bottle lifter shaft includes a shaft cam ramp, and the bottle lifter includes a plurality of locking arms that move radially inward via the shaft cam ramp when the bottle lifter moves toward the retracted position. Each locking arm includes a locking shoulder configured to engage a bottle inserted into the bottle lifter when the bottle lifter is in the retracted position.

7. The transfer device according to claim 6, wherein, The bottle lifter includes a plurality of radially extending locking tabs, each locking tab including a locking post, and each locking arm including a locking claw. When the locking post is not engaged by a bottle located in the bottle lifter, the locking claw engages with the locking tab to restrict movement of the bottle lifter toward a retracted position. When the locking post is engaged by a bottle located in the bottle lifter, as the bottle lifter moves toward the retracted position, the locking tabs move to a position where they are not engaged by the locking claw.

8. The transfer device according to claim 7, wherein, The vial lifter includes a vial needle opening that receives a vial needle when the vial lifter is in the retracted position. The vial needle is configured such that it will not pass through the vial needle opening when the vial lifter locking claw engages the locking tab.

9. The transfer device according to any one of claims 1-8, wherein, The bottle lifter includes a cam hook and a cam ring rotatably positioned around the bottle lifter. The cam ring includes a cam surface configured to be passed through by the cam hook when the bottle lifter moves from an extended position to a retracted position, thereby rotating the cam ring. The cam ring is also configured to deflect and release the trigger spring when it rotates.

10. The transfer device according to claim 9, wherein, The cam ring includes a linkage hook and a link attached to the linkage hook and a trigger spring, the link being configured to deflect and release the trigger spring when the cam ring rotates.

11. The transfer device according to claim 9, wherein, The bottle lifter includes a spline, the cam hook is positioned on the spline, and the lifter shaft includes a slot in which the spline travels when the bottle lifter moves from the extended position to the retracted position.

12. The transfer device according to claim 9, further comprising a vent and a piston assembly, the piston assembly including a piston spring and a seal, wherein, The piston spring is configured to push the seal toward a position that allows airflow through the vent when the pressure inside the expansion chamber drops below a first predetermined level.

13. The transfer device of claim 12, further comprising a retaining band and a pivot plate, the retaining band being configured to secure the injection device to the transfer device, wherein the pivot plate is pivotally mounted to the transfer device to pivot between a latching position in which the pivot plate engages the retaining band and a release position in which the retaining band is released, the pivot plate being operably connected to the piston assembly such that the pivot plate pivots to the release position when the pressure in the expansion chamber drops below a second predetermined level.

14. The transfer device according to claim 13, wherein, The piston spring is a compression helical spring, and also includes a torsion spring configured to push the pivot plate to the release position.

15. The transfer device according to claim 1, wherein, The vial needle includes a sleeve in fluid communication with the liquid channel and a gas tube located within the sleeve, wherein the gas tube is in fluid communication with the gas channel.

16. A method for transferring a liquid drug from a vial to an injection device using the transfer device of claim 1, comprising the following steps: a. The pressure vessel is punctured using a puncture tip by providing relative movement between the pressure vessel and the puncture tip through a deflected and then released trigger spring; b. Depressurize the air supply from the punctured pressure vessel in the expansion chamber; c. Guide air from the expansion chamber to the vial to expel the liquid medication from the vial; d. Guide the liquid medication from the vial to the injection device.

17. The method of claim 16, further comprising filtering the liquid drug as it travels into the injection device.

18. The method according to claim 16, wherein, Step ad is performed by the transfer device and also includes the following steps: a. Use a retaining strap to prevent the injection device from being removed from the transfer device; b. When the pressure inside the expansion chamber drops below a predetermined level, release the retaining band.

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