Pharmaceutical filling system

Abstract

A drug filling system (30) supplies a drug to a delivery device (20). The drug filling system (30) includes a main housing (40) having: an air pump (42); a vial adapter (44) configured to engage a vial (10) containing the drug, the vial adapter (44) being in communication with the air pump (42); a syringe housing (46) carrying a syringe (70), the syringe housing (46) being selectively in communication with the vial adapter (44) and the delivery device (20); and a valve (60) that locks and unlocks movement of a plunger (72) in the syringe (70).

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 908,343, filed September 30, 2019, pursuant to 35 U.S. SC §119(e), which is incorporated herein by reference in its entirety. Technical Field

[0003] Various exemplary embodiments of the present invention relate to filling a delivery device with a drug via a drug filling system such as a syringe assembly. Background Technology

[0004] Systems such as delivery devices and syringe assemblies are commonly used to administer medications, such as insulin, to patients. However, inefficiencies and inconveniences can arise. These challenges include minimizing air entering the delivery device, preventing backflow of medication during and after the filling step, and improving safety, operability, and stability. Summary of the Invention

[0005] One aspect of the invention is to provide a pharmaceutical filling system that facilitates improved alignment and engagement with a delivery device. During engagement, the pharmaceutical filling system removes unwanted air from the delivery device before filling it with pharmaceuticals. After filling the delivery device with pharmaceuticals, the pharmaceutical filling system is configured to prevent backflow of pharmaceuticals from the delivery device into the pharmaceutical filling system. Such a system provides efficient and improved accuracy in transferring pharmaceuticals to the delivery device.

[0006] Another aspect of the invention provides a syringe assembly for filling a delivery device with a medication. After filling is complete, the syringe assembly is locked to prevent medication from flowing back into the syringe assembly.

[0007] In another aspect of the invention, the syringe assembly includes an adapter with ergonomic features to improve safety, operability, and stability. In yet another aspect of the invention, the adapter has a needle that engages a needleless syringe that can be reused to fill the delivery device.

[0008] The foregoing and / or other aspects of the present invention can be achieved by providing a pharmaceutical filling system for supplying a pharmaceutical agent to a delivery device, the pharmaceutical filling system comprising a main housing having: an air pump; a vial adapter configured to engage a vial containing the pharmaceutical agent, the vial adapter being in communication with the air pump; a cylinder selectively in communication with the vial adapter and the delivery device; and a valve that locks and unlocks movement of a plunger within the cylinder.

[0009] The foregoing and / or other aspects of the present invention can also be achieved by providing a method for filling a delivery device with a drug using a drug filling system, the method comprising attaching the drug filling system to the delivery device, establishing fluid communication between the delivery device and the drug filling system, connecting a vial to the drug filling system to establish fluid communication, setting a dosage on a plunger of a cylinder in the drug filling system, releasing the plunger of the cylinder, pulling the plunger to remove air from the delivery device, transferring the drug from the vial to the cylinder, and filling the delivery device with the drug.

[0010] The foregoing and / or other aspects of the present invention can also be achieved by providing a pharmaceutical filling system for supplying a pharmaceutical agent to a delivery device, the pharmaceutical filling system comprising an alignment platform having a needle configured to communicate with the delivery device, the alignment platform comprising: an air pump for removing air from the delivery device; a diaphragm configured to engage the air pump; and a needle cover that closes the needle when it is not in use.

[0011] The foregoing and / or other aspects of the present invention can also be achieved by providing a syringe assembly for delivering a drug to a delivery device, the syringe assembly including: a dose scale for setting a dose amount disposed on a plunger head; a plunger including a plunger head disposed on a proximal end of the plunger; and a syringe barrel connected to a needle; and a plunger locking assembly, wherein after the syringe delivers the drug to the delivery device, the plunger locking assembly prevents the drug from flowing back into the syringe.

[0012] The foregoing and / or other aspects of the present invention can also be achieved by providing a syringe assembly for filling a syringe and delivery device with a pharmaceutical agent, the syringe assembly including a syringe having: a needle for transferring the pharmaceutical agent; and an adapter configured to engage a vial carrying the pharmaceutical agent, wherein the adapter includes one of an ergonomic feature or a needle depth control feature.

[0013] The foregoing and / or other aspects of the present invention can also be achieved by providing a syringe assembly for filling a syringe and a delivery device with a drug, the syringe assembly comprising: a needleless syringe having a syringe connector; an adapter including a needle configured to engage a vial carrying a drug; and an adapter connector configured to engage the syringe connector, wherein the distal end of the adapter engages the vial to receive the drug and engages the delivery device to transfer the drug.

[0014] Finally, the foregoing and / or other aspects of the present invention can also be achieved by providing a syringe assembly for filling a syringe and a delivery device with a drug, the syringe assembly comprising: a syringe having a needle for transferring the drug; and an adapter attached to the syringe and configured to engage a drug-carrying vial, the adapter including a housing that encloses the syringe and a base configured to be mounted on a delivery device, wherein when the adapter is engaged with the vial, the drug travels from the vial to the syringe, and when the adapter is engaged with the delivery device, the drug travels from the syringe to the delivery device.

[0015] Additional and / or other aspects and advantages of the invention will be set forth in the description which follows, or will be apparent from the description, or may be learned by practice of the invention. Attached Figure Description

[0016] The above aspects and features of the invention will become more apparent from the description of exemplary embodiments thereof with reference to the accompanying drawings, wherein:

[0017] Figure 1 This is a schematic diagram of a first exemplary embodiment of a pharmaceutical filling system;

[0018] Figure 2 yes Figure 1 A perspective view of the pharmaceutical filling system;

[0019] Figure 3 yes Figure 2 A transparent perspective view of the pharmaceutical filling system;

[0020] Figure 4 This is shown as the path when air is removed from the delivery device. Figure 2 A cross-sectional view of the drug filling system taken by line AA;

[0021] Figure 5 This is shown as the path when delivering a drug to a delivery system. Figure 2 A cross-sectional view of the drug filling system taken by line AA;

[0022] Figure 6 This is a schematic diagram of a second exemplary embodiment of the pharmaceutical filling system;

[0023] Figure 7 yes Figure 6 Exploded view of the pharmaceutical filling system;

[0024] Figure 8 Is with Figure 7 An exploded view of a syringe assembly used in conjunction with a drug filling system;

[0025] Figure 9 Is with Figure 8A perspective view of the plunger locking assembly used in conjunction with the syringe assembly;

[0026] Figure 10 It is the plunger locking assembly along Figure 9 A cross-sectional view of line BB;

[0027] Figure 11 This is a perspective view of a third exemplary embodiment of a syringe assembly attached to a medicine bottle via an adapter;

[0028] Figure 12 It shows in Figure 11 A first embodiment of an adapter used in a syringe assembly;

[0029] Figure 13 It shows in Figure 11 A second embodiment of the adapter used in the syringe assembly;

[0030] Figure 14 It shows in Figure 11 A third embodiment of the adapter used in the syringe assembly;

[0031] Figure 15 It shows when removed from the vial Figure 11 The adapter used in the syringe assembly;

[0032] Figure 16 This is a side perspective view of a fourth exemplary embodiment of a syringe assembly having an integrated adapter attached to a vial;

[0033] Figure 17 yes Figure 16 Top perspective view of the syringe component;

[0034] Figure 18 It is installed on the delivery device Figure 16 Bottom perspective view of the syringe assembly;

[0035] Figure 19 This is a perspective view of a fifth exemplary embodiment of a syringe assembly without an adapter;

[0036] Figure 20 yes Figure 19 A perspective view of the syringe assembly engaging with the vial to fill the medication;

[0037] Figure 21 yes Figure 19 A perspective view of the syringe assembly engaging with the delivery device to transfer the medication;

[0038] Figure 22 This is a sixth exemplary embodiment of a needleless injector assembly with a needle adapter and an exploded view of a vial;

[0039] Figure 23 It is shown as being connected to the medicine bottle. Figure 22 A perspective view of the syringe assembly shown;

[0040] Figure 24 It is shown as a joining delivery device Figure 22 A perspective view of the syringe assembly shown;

[0041] Figure 25 It is shown as an edge for joining to the delivery device Figure 24 A cross-sectional view of the syringe assembly taken by line CC;

[0042] Figure 26 This is a cross-sectional view of a seventh exemplary embodiment of a syringe assembly having an alignment adapter that engages with a delivery device;

[0043] Figure 27 yes Figure 26 Exploded view of the syringe assembly and vial;

[0044] Figure 28 A delivery device is shown, which is configured to engage Figure 26 syringe components;

[0045] Figure 29 This is a flowchart of a method for transferring medication into a syringe assembly using an adapter before the medication is dispensed into the delivery device. Detailed Implementation

[0046] Figure 1-5 A drug filling system 30 according to one embodiment is shown. The drug filling system 30 is configured to engage a drug vial 10 to receive a drug and to engage an insulin delivery device (IDD) 20 to transfer and fill the drug. Figure 1 A schematic diagram of the overall operation of the drug filling system 30 is shown. Figure 2-5 A cavity on the bottom surface of the drug filling system 30 is shown, which advantageously provides alignment and is configured to engage the insulin delivery device 20.

[0047] Figure 2 and 3 The drug filling system 30 is shown to include a main housing 40, which includes an air pump 42, a vial adapter 44, a flow path 45, a cylinder 46 with a viewing window 48, an outlet port 50 communicating with a needle 54, and a spring element 52 cooperating with a spring 53. The air pump 42 is preferably manually operated, but can also be operated automatically. The air pump 42 is in fluid communication with the vial adapter 44.

[0048] When a user wishes to transfer medication from vial 10 to cylinder 46 within the main housing 10, vial 10 is attached to vial adapter 44. Vial adapter 44 includes a double-lumen vial tip that pierces the diaphragm within vial 10. The user then uses air pump 42 to pump air into vial 10. This increased pressure within vial 10 causes the medication to exit vial 10 and enter cylinder 46 via flow path 45.

[0049] The syringe 46 carries the medication and includes a viewing window 48 to provide a visual indication of how much medication is in the syringe 46. Specifically, the viewing window 48 is translucent and may include a dosage mark that is visible when the user observes how much medication is in the syringe 46 through the viewing window 48. The syringe 46 may also include a buoyant, colored member that floats on top of the medication to indicate how much medication is in the syringe 46 when observed through the viewing window 48. Further details of the syringe cartridge component 70 will be described below.

[0050] like Figure 4 and 5 As shown, the main housing 40 also includes an outlet port 50 disposed in the spring element 52, which selectively communicates with the needle 54 and the insulin delivery device 20 based on the movement of the manual switching valve 60. The needle 54 is disposed in a cavity on the bottom surface of the drug filling system 30. The needle 54 is configured to puncture the septum in the insulin delivery device 20. The manual switching valve 60 advantageously controls a three-way valve and cooperates with a plunger locking feature. Further details of the manual switching valve 60 will be described below.

[0051] Figure 1 A manual on / off valve 60 is shown positioned between the vial adapter 44, the insulin delivery device 20, and the cartridge 46 to provide selective fluid communication. Figure 1 A manual air pump 42 is also shown. Figure 4 The manual switch valve 60 is shown being pressed to actuate the spring element 52. In this configuration, the main housing 40 communicates with the insulin delivery device 20 to remove air through the outlet port 50 and needle 54. Air removal occurs when the user pulls the venting plunger 72 upward. The flow path 45 between the vial adapter 44 and the cartridge 46 is misaligned and disengaged at this position.

[0052] Figure 5 The manual switch valve 60 is shown released (natural position), which allows the spring element 52 and outlet port 50 to be misaligned with the needle 54. Therefore, the main housing 40 is not in fluid communication with the insulin delivery device 20. Instead, the flow path 45 is aligned to provide fluid communication between the vial adapter 44 and the cartridge 46. As a result, medication is transferred from the vial 10 to the cartridge 46.

[0053] In order to transfer the drug to the insulin delivery device 20, such as Figure 4 As shown, the manual switch valve 60 is pressed to align the cylinder 46, outlet port 50, and needle 54. The user then presses the vent plunger 72 to transfer the medication. This position is thus used to remove air from the insulin delivery device 20 and transfer the medication into the insulin delivery device 20.

[0054] Spring element 52 is a rigid component disposed near the bottom surface of the main housing 40. As described above, spring element 52 cooperates with manual on / off valve 60 to control the flow of the medicine. Specifically, as Figure 2 and 3 As shown, spring element 52 engages spring 53, which descends to its lowest point on a portion of the main housing 40 to ensure compression. This configuration allows spring element 52 to slide into various flow path positions based on user operation of the manual switching valve 60.

[0055] like Figure 2 , 4 As shown in Figure 5, the manual switching valve 60 includes an arm 62, a pivot 64, a stop element 66, and a button 68. As described above, the manual switching valve 60 is equipped with a button 68 to control the operation of the drug filling system 30. Specifically, the button 68 is located at the distal end of the arm 62, adjacent to the spring element 52. The stop element 66 is located at the proximal end of the arm 62, near the top of the cylinder 46.

[0056] As described below, the stop element 66 is configured to engage and disengage one of a plurality of dose scale stops 76 to aid in dose setting. Figure 2 As shown, a stop element 66 may also be provided at the top of the cylinder 46 to advantageously prevent backflow after the medication has been transferred to the insulin delivery device 20. In this way, the user is not advantageously required to keep the vent plunger 72 down after medication delivery to ensure that the medication does not leave the insulin delivery device 20.

[0057] Arm 62 rotates about a pivot 64 disposed between button 68 and stop element 66. Pivot 64 allows arm 62 to rotate between an engaged position and a disengaged position based on user activation of button 68.

[0058] The syringe barrel assembly 70 includes a vent plunger 72, a dose scale 74, and a plurality of dose scale stops 76. The vent plunger 72 advantageously includes a fluid-blocking membrane that prevents medication from exiting the barrel 46, and a one-way valve that allows air to escape from the barrel 46 while retaining medication therein. Specifically, the vent plunger 72 allows air to leave the medication filling system 30 when air is removed from the insulin delivery device 20. Furthermore, when the barrel 46 is filled with medication, air previously located in the barrel 46 is released through the vent plunger 72.

[0059] A dose scale 74 is positioned on the proximal end of the ventilation plunger 72. The user rotates the dose scale 74 to set the desired dose. As the dose scale 74 rotates, the plunger 72 also rotates along with a plurality of dose scale stops 76 disposed on the plunger 72. Figure 3 A plurality of dose scale stops 76 are shown, each corresponding to a different dose. Preferably, the dose scale stops 76 are molded in the plunger 72 and along the axial length of the plunger 72. Based on the set dose from the dose scale 74, one of the dose scale stops 76 is aligned with the stop element 66 to limit the amount of drug entering the cylinder 46.

[0060] For example, some insulin delivery devices 20 may incorporate a flexible storage chamber, such as a flexible pouch. These insulin delivery devices 20 can provide back pressure during drug filling, as well as excess air that should be removed during drug filling to provide high accuracy. The drug filling system 30 disclosed herein advantageously prevents drug backflow and removes air to improve filling accuracy and control drug delivery volume, while minimizing needle exposure.

[0061] Figure 6-10 A pharmaceutical filling system 130 according to a second embodiment is shown. Figure 6 A schematic diagram of a drug filling system 130 is shown, which cooperates with a vial 110 and an insulin delivery device 120 as described similarly above. The drug filling system 130 also includes a needle-free vial adapter 140, an alignment platform 150, a needle-free injector 170, and a plunger locking assembly 180. Advantageously, the alignment platform 150 is the only component in the drug filling system 130 that uses a needle.

[0062] Figure 6 and 8 The proximal end of the vial adapter 140 is shown to include a Luer lock 142. The proximal end of the vial adapter 140 is configured to engage the syringe 170 to establish fluid communication. The distal end of the vial adapter 140 is configured to establish fluid communication by piercing a septum in the vial 110 via a needle (not shown).

[0063] Figure 6 and 7 Alignment platform 150 is shown. The lower surface of alignment platform 150 advantageously provides an alignment element for mounting purposes and is configured to engage insulin delivery device 120. Alignment platform 150 includes a slit diaphragm 152, a fixation device cavity 154, an air pump 156, a needle cover 158, and a needle 160. Slit diaphragm 152 provides selective fluid communication with air pump 156 and syringe 170. Fixation device cavity 154 provides space for mounting alignment platform 150 using a fixation device and providing stability.

[0064] The air pump 156 differs from the air pump used in the embodiments described above. Specifically, the air pump 156 is preferably operated automatically, but it can also be operated manually. The air pump 156 is removable. The air pump 156 includes two one-way valves and a retractable chamber, such as a ball joint, bellows, or piston cylinder. The air pump 156 is configured to engage the slit diaphragm 152 and remove air from the insulin delivery device 120 before filling with medication. Figure 6 As shown, needle 160 is disposed on the lower surface of alignment platform 150 and aligned with slit diaphragm 152. Needle 160 is configured to pierce the diaphragm of insulin delivery device 120 to establish fluid communication with alignment platform 150.

[0065] The needle cover 158 is used to cover the needle 160 and engage the alignment platform 150. For example... Figure 7 As shown, the needle cover 158 is uniquely shaped to surround the slit diaphragm 152 and the Luer connector, while engaging the top and bottom surfaces of the alignment platform 150 to ultimately cover and seal the needle 160.

[0066] Figure 8 A syringe 170 is further shown, which has a plunger 172, a plunger head 174, a dose scale 176, and a syringe barrel (not shown), as is conventionally understood by those skilled in the art. Figure 9 and 10 A plunger locking assembly 180 cooperating with syringe 17 is shown. As all the medication is dispensed from the syringe barrel, the plunger locking assembly 180 advantageously locks the plunger 172 to prevent medication from flowing back into the syringe barrel.

[0067] The plunger locking assembly 180 includes a locking button 182, a locking flange 184 having a first protrusion 186 and a second protrusion 188, a locking base 190, a circular extruder 191, a base locking flange 192, and a compression spring 198. The locking button 182 is advantageously and conveniently positioned above the plunger head 174 of the plunger 172. The locking button 182 is button-shaped and includes a plurality of legs or locking flanges 184 extending through a cavity in the plunger head 174.

[0068] like Figure 9 and 10 As shown, the syringe 170 also includes an accidental press prevention ring 178. The accidental press prevention ring 178 includes a raised surface surrounding the locking button 182 to advantageously prevent the locking button 182 from being accidentally pressed. In one embodiment, the accidental press prevention ring 178 includes a continuous wall surrounding the locking button 182. In another embodiment, the accidental press prevention ring 178 includes a wall having gaps spaced apart around the locking button 182.

[0069] For example, if the user drops the syringe 170, the locking button 182 will not be pressed beyond the top surface of the anti-accidental trigger ring 178 to safely prevent accidental triggering. The anti-accidental trigger ring 178 is designed to require intentional pressing of the locking button 182, which extends into the anti-accidental trigger ring 178. This configuration advantageously prevents accidental triggering of the locking button 182 of the plunger locking assembly 180 while allowing the user's fingers to operate the syringe 170.

[0070] Each of the multiple locking flanges 184 includes a first protrusion 186 and a second protrusion 188. The first protrusion 186 secures the plunger locking assembly 180 to the plunger head 174 of the syringe 170. When in the locked position, the second protrusion 188 secures the locking button 182 to the locking base 190.

[0071] like Figure 9 As shown, the locking base 190 is preferably secured to the syringe barrel by a snap-locking device, but other securing methods are also considered. The locking base 190 includes a circular extrusion 191 extending upward and toward the plunger head 174. A plurality of base locking flanges 192 are disposed at the inner diameter and proximal end of the circular extrusion 191. The plurality of base locking flanges 192 engage a second protrusion 188 of the locking button 182 to lock the plunger 172 after drug dispensing. The plunger head 174 can also be rotated from the locked position to disengage the plunger 172 from the locking button 182 and into the unlocked position.

[0072] A compression spring 198 is disposed between the locking button 182 and the plunger head 174 to hold the locking button 182 in the unlocked position before the user compresses it into the locked position. Therefore, in the unlocked position, the compression spring 198 is compressed to allow the plunger 172 to operate. However, in the locked position after medication dispensing, the compression spring 198 is further compressed to engage the plurality of base locking flanges 192 with the second protrusion 188 of the locking button 182.

[0073] Figure 11-15 A syringe assembly 230 according to a third embodiment is shown, which fills a syringe 240 with medication and dispenses the medication into an insulin delivery device 220. The syringe assembly 230 includes a syringe 240 having well-known components, such as a flange 242 allowing a user to grip the syringe 240, a cartridge 243 carrying the medication, a dose indicator 244 providing a visual indication of the dosage in the syringe 240, a plunger 245 for moving the medication into and out of the cartridge 243, a plunger head 246 providing space for finger pressing / actuation, and a needle 248 on which the medication flows.

[0074] The syringe assembly 230 also includes an adapter 250 that provides alignment between the syringe 240 and the vial 210, and alignment between the syringe 240 and the insulin delivery device 220. The adapter 250 also allows the user to hold the vial 210 and the syringe 240 together when engaged. Figure 11 The syringe 230 is shown during the engagement of the adapter 250. Figure 15 A syringe 230 detached from adapter 250 is shown. Adapter 250 includes an alignment tube 252 that facilitates aligning syringe 240 with vial 210 or insulin delivery device 220.

[0075] Compared to syringe 240, alignment tube 252 is a larger target. As a result, alignment tube 252 advantageously allows the user to more efficiently align syringe 240 and adapter 250 for engagement with vial 210 or insulin delivery device 220. Improved alignment efficiency also advantageously reduces accidental needle bending. Locking mechanism 254, preferably a snap-lock or threaded lock, is provided on the distal end of adapter 250 to engage vial 210 and insulin delivery device 220.

[0076] Figure 12-14 Several embodiments of the adapter 250 are shown, which provide various advantageous features related to ergonomics and control of needle depth. Figure 12 Two arms 256 on the alignment tube 252 of the adapter 250 are shown, which protrude outward from the centerline of the alignment tube 252 to advantageously assist in the ergonomic handling and control of the syringe assembly 230.

[0077] Figure 13 Multiple curved recesses 257 are shown, each recess having a centrally located protrusion 258. The curved recesses 257 are advantageously configured to ergonomically engage the user's fingers, and the protrusions 258 advantageously provide friction for the user to maintain a grip on the adapter 250.

[0078] Figure 14 A needle depth control mechanism 259 is shown. The alignment tube 252 is replaced by, or preferably cooperates with, the needle depth control mechanism 259. The needle depth control mechanism 259 includes a sleeve assembly having two or more collinear sleeves that rotate relative to each other. The sleeve assembly functions as a telescopic device; its inner diameter decreases as it rotates, similar to a telescopic rod.

[0079] The needle depth control mechanism 259 advantageously controls the needle insertion into the vial 210 and insulin delivery device 220, and reduces needle pricks. This configuration is particularly advantageous for maximizing drug extraction from the vial 210, as a shorter needle allows for the recovery of more drug. Furthermore, the sleeve assembly of the needle depth control mechanism 259 is retractable to store the adapter 250 in a compact and secure space.

[0080] Figure 16-18 A syringe assembly 230 according to a fourth embodiment is shown, as described similarly above, but including an alternative adapter 251. In this embodiment, the adapter 251 is integrated into a plunger locking assembly 270. The plunger locking assembly 270 includes a housing 272, a flange slot 278, a plunger lock 280, and a mounting flange 282.

[0081] The housing 272 of the plunger locking assembly 270 carries or encloses the syringe assembly 230. The flange slot 278 is a cavity that engages the flange 242 of the syringe 240. Figure 17 It is shown that after the drug is dispensed, the plunger lock 280 is positioned above the plunger head 246 to prevent backflow into the syringe 240. Figure 16 and 18 A mounting flange 282 is shown at the distal end of the plunger locking assembly 270 to provide engagement with the vial 210, and a mounting surface is also provided for alignment when engaging the insulin delivery device 220.

[0082] Figure 19-21 A syringe assembly 230 according to a fifth embodiment is shown, which has no adapter and a second embodiment having a plunger locking assembly 271. The plunger locking assembly 271 includes some of the features described above and also includes a dosage window 274 and a gripping surface 276. Specifically, the housing 272 of the plunger locking assembly 271 includes the gripping surface 276 for a user to securely grip the plunger locking assembly 271.

[0083] Figure 20 A syringe 240 is shown attached to a plunger locking assembly 271 that engages with a vial 210. A dosage window 274 on the housing 272 of the plunger locking assembly 271 is advantageously enlarged to allow the user to conveniently see the amount of dosage in the barrel 243 of the syringe 240 and the gradual movement of the plunger 245 during filling and dispensing. Figure 21 The syringe 240 in the plunger locking assembly 271 is shown engaging with the insulin delivery device 220 to transfer the drug.

[0084] Figure 22-25 A syringe assembly 330 according to a sixth embodiment is shown. In this embodiment, the vial 310 and insulin delivery device 320 are similar to those described above. Figure 24An insulin delivery device 320 is shown, which includes a septum 324 and a thin film cover 322 to close the insulin delivery device 320 and the septum 324 before use. The septum 324 provides selective fluid communication to the insulin delivery device 320.

[0085] The syringe assembly 330 includes a needleless syringe 340 and a syringe connector 342. The needleless syringe 340 is advantageously used to reduce needle pricks and improve safety. The syringe connector 342 is preferably a Luer connector, but other forms of engagement are also possible.

[0086] The syringe assembly 330 also includes an adapter 350 configured to engage the vial 310 and the insulin delivery device 320. The adapter 350 includes an adapter connector 352 configured to engage the syringe connector 342. A needle 354 is disposed at the distal end of the adapter 350 to engage the septum of the vial 310 and the insulin delivery device 320. Before use, the needle 354 is sealed by a rubber sleeve 356 to protect it from accidental use.

[0087] Figure 23 The diagram shows a syringe 330 connected to an adapter 350 and engaged with a vial 310 to fill the syringe 330 with medication. After filling, Figure 25 The syringe 330 is shown connected to the adapter 350 and engaged with the insulin delivery device 320. Specifically, the needle 354 of the adapter 350 pierces the septum 324 of the insulin delivery device 320 to establish fluid communication.

[0088] Figure 26-28 A syringe assembly 430 according to a seventh embodiment is shown. In this embodiment, the vial 410 and insulin delivery device 420 are similar to those described above. However, Figure 28 The insulin delivery device 420 also includes an alignment imprint 422 and a needle port 424. The alignment imprint 422 includes an outline printed on a label of the insulin delivery device 420 to guide engagement of the syringe assembly 430. The needle port 424 is a hole alignment feature to provide mechanical alignment between the insulin delivery device 420 and the syringe assembly 430.

[0089] The syringe assembly 430 includes a syringe 440 having a needle 442, a flange 444, and a needle cover 446, as conventionally understood by those skilled in the art. Figure 26 The syringe 440 is shown in the adapter 450. Figure 27 An exploded view of a syringe assembly 430 is shown, wherein the adapter 450 includes a housing 452, a slot 454, a base 456, and a hole 458.

[0090] The housing 452 is configured to carry the syringe 440. The slot 454 is configured to engage the flange 444 of the syringe 440 to secure the engagement. The base 456 is used for mounting to the insulin delivery device 420 and is also configured to engage the vial 410. Figure 27 and 28 As shown, the base 456 is positioned on the alignment imprint 422 of the insulin delivery device 420, thereby allowing for proper alignment and engagement. A hole 458 in the base 456 provides mechanical alignment with the needle port 424 of the insulin delivery device 420.

[0091] Figure 29 A flowchart illustrating how a user transfers medication from a vial to a syringe assembly using an adapter, as described in several related embodiments above, is presented. This transfer occurs before the medication is dispensed into the delivery device. Step 500: Attach the vial adapter to the vial. Step 505: Attach the needle to the syringe. Step 510: Retract the plunger to the desired dose. Step 515: Move the needle cover. Step 520: Insert the syringe into the vial adapter until the needle enters the vial. Step 525: Press the plunger to provide air pressure into the vial. Step 530: Rotate the syringe and vial so that the vial is positioned above the syringe. The user then retracts the plunger to draw in the desired dose of medication. Step 535: Remove the syringe from the vial and vial adapter. Step 540: The syringe is now ready to fill the insulin delivery device.

[0092] The foregoing detailed description of certain exemplary embodiments has been provided to explain the principles of the invention and its practical application, thereby enabling others skilled in the art to understand various embodiments of the invention and various modifications suitable for the intended particular use. This description is not necessarily exhaustive or intended to limit the invention to the precise embodiments disclosed. Furthermore, any of the embodiments, features, and / or elements disclosed herein can be combined with each other to form various additional combinations not specifically disclosed, provided that the combined embodiments, features, and / or elements do not contradict each other. Therefore, additional embodiments are possible and are intended to be included within the scope of this specification and the invention. This specification describes specific examples to achieve a more general objective, which can be achieved in another manner.

[0093] As used herein, the terms “front,” “back,” “up,” “down,” “upward,” “downward,” and other orientation descriptors are intended to facilitate the description of exemplary embodiments of the invention and are not intended to limit the structure of exemplary embodiments of the invention to any particular location or orientation. Degree terms such as “substantially” or “approximately” are understood by those skilled in the art to refer to a reasonable range around and including a given value, for example, general tolerances associated with the manufacture, assembly, and use of the described embodiments.

Claims

1. A pharmaceutical filling system for supplying a pharmaceutical agent to a delivery device, the pharmaceutical filling system comprising: Main housing, the main housing having: air pump; A medicine bottle adapter configured to engage a medicine bottle containing medication, the medicine bottle adapter being in communication with the air pump; A tube, which is selectively connected to the vial adapter and the delivery device; and The valve locks and unlocks the movement of the plunger within the cylinder. The valve includes a pivot and a button connected to an arm, the arm including a stop element, the arm rotating relative to the pivot such that the stop element engages and disengages with the plunger in the cylinder.

2. The pharmaceutical filling system according to claim 1, wherein: The valve is unlocked to remove air from the cylinder from the delivery device; The valve is locked to prevent the cylinder from receiving more than a preset dose of the medicine from the vial adapter; The valve is unlocked to deliver the medicine from the cylinder to the delivery device; and After the medicine is delivered, the valve is locked to prevent the medicine from flowing back from the delivery device into the cylinder.

3. The pharmaceutical filling system according to claim 1, wherein: When the button is pressed, the plunger in the cylinder disengages from the stop element.

4. The pharmaceutical filling system according to claim 1, wherein: The stop element is located at the distal end of the arm.

5. The pharmaceutical filling system according to claim 1, wherein: The plunger of the cylinder expels air from the cylinder; The plunger includes a dose scale located at the proximal end of the plunger and a corresponding dose scale stop position for indicating the dose; and The cylinder includes a viewing window for indicating the amount of medicine contained in the cylinder.

6. A method for filling a delivery device with a pharmaceutical agent using the pharmaceutical filling system according to claim 1, the method comprising: Attach the drug filling system to the delivery device; Establish fluid communication between the delivery device and the drug filling system; Connect the medicine bottle to the medicine filling system to establish fluid communication; The dosage is set on the plunger of the cylinder in the drug filling system; Release the cylinder via the valve to allow operation of the plunger and the cylinder; Pull the plunger to remove air from the delivery device; The valve locks the cylinder to prevent movement of the plunger and the cylinder; Transfer the medicine from the medicine bottle to the cylinder; Press the valve to release the plunger and the cylinder to perform the operation; and The delivery device is filled with the drug.

7. The method of claim 6, further comprising rotating the plunger of the cylinder after the transfer step to set the dosage.

8. The method of claim 6, further comprising puncturing a diaphragm in the delivery device to establish fluid communication with the drug filling system.

9. The method of claim 6, further comprising pumping air into the vial to transfer the medicine from the vial to the cylinder.

10. The method of claim 6, further comprising venting excess air from the plunger of the cylinder after the locking step.

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