Compressed gas autoinjector

Abstract

A medicament delivery device, the medicament delivery device comprising: a housing; a container provided within the housing and configured to contain a medicament; the plunger is arranged in the container in a sliding manner; a plunger rod configured to urge the plunger through the container to dispense the medicament when the container contains the medicament; and a gas canister configured to travel with the plunger rod and contain compressed gas, where the gas canister is configured to release the compressed gas to drive the plunger rod to dispense the medicament out of the distal end of the container.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480061658.5 (22) Application Date 2024.09.27 (30) Priority Data 63 / 586,999 2023.09.29 US (85) PCT International Application Entering National Phase Date 2026.03.25 (86) PCT International Application Application Data PCT / US2024 / 049077 2024.09.27 (87) PCT International Application Publication Data WO2025 / 072836 EN 2025.04.03 (71) Applicant Gilead Sciences, Inc. Address: California, USA (72) Inventors C.D. Boudista Trevino J. Coates R. Earl W. Harris K. Hewson J. Hills L.S.T. Ho M. Patel F.A. Penrose J. Shefferd (74) Patent Agency King & Wood Mallesons, Beijing 11256 Patent Attorney Ma Hui Lv Xiaoyu (51) Int.Cl. A61M 5 / 20 (2006.01) (54) Invention Title: Compressed Gas Auto-Injector (57) Abstract: A drug delivery device comprising: A housing; a container disposed within the housing and configured to contain a pharmaceutical agent; a plunger slidably disposed within the container; a plunger rod configured to push the plunger through the container to dispense the pharmaceutical agent when the container contains the pharmaceutical agent; and a gas canister configured to travel with the plunger rod and contain compressed gas, wherein the gas canister is configured to release the compressed gas to drive the plunger rod to dispense the pharmaceutical agent from a distal end of the container. Claims (3 pages), Description (9 pages), Drawings (13 pages), CN 121909055 A, 2026.04.21, CN 1 21 90 90 55 A 1. A drug delivery device, comprising: a housing; a container disposed within the housing and configured to contain a drug; a plunger slidably disposed within the container; a plunger rod configured to push the plunger through the container to dispense the drug when the container contains the drug; and a gas canister configured to travel with the plunger rod and contain compressed gas, wherein the gas canister is configured to release the compressed gas to drive the plunger rod to dispense the drug from a distal end of the container. 2. The drug delivery device of claim 1, wherein the container contains 1 mL to 10 mL of drug. 3. The drug delivery device of claim 1 or claim 2, wherein the container contains 2 mL to 8 mL of drug.4. The drug delivery device according to any one of claims 1 to 3, wherein the container contains 4 mL to 6 mL of drug. 5. The drug delivery device according to any one of claims 1 to 4, wherein the container contains 5 mL of drug. 6. The drug delivery device according to any one of claims 1 to 2, wherein the container contains 3 mL to 10 mL of drug. 7. The drug delivery device according to any one of claims 1 to 6, wherein the drug has a viscosity in the range of 1 cP to 3000 cP. 8. The drug delivery device according to any one of claims 1 to 7, wherein the drug has a viscosity in the range of 1 cP to 2250 cP. 9. The drug delivery device according to any one of claims 1 to 8, wherein the drug has a viscosity in the range of 1750 cP to 2750 cP. 10. The drug delivery device according to any one of claims 1 to 9, wherein the drug has a viscosity in the range of 2000 cP to 2200 cP. 11. The drug delivery device according to any one of claims 1 to 10, wherein the drug has a viscosity of at least 2200 cP. 12. The drug delivery device of any one of claims 1 to 11, further comprising a button configured to activate an element configured to puncture the gas canister, wherein the gas canister is configured to release the compressed gas upon puncture. 13. The drug delivery device of any one of claims 1 to 12, further comprising an interlocking device configured to prevent the element from puncturing the gas canister when the interlocking device is in a locked position. 14. The drug delivery device of claim 13, wherein the housing includes a cutout configured to receive the interlocking device when the interlocking device is in an unlocked position. 15. The drug delivery device of claim 14, wherein the cutout allows the interlocking device to bend radially when the interlocking device is in the unlocked position. 16. The drug delivery device of any one of claims 13 to 15, wherein the housing prevents the interlocking device from bending radially when the interlocking device is in the locked position. 17. The drug delivery device according to any one of claims 1 to 16, further comprising a needle configured to be attached to a distal end of the container. 18. The drug delivery device according to claim 17, wherein the interlocking device is configured to move to an unlocked position when the needle is attached to the drug delivery device. 19. The drug delivery device according to claim 17 or claim 18, wherein the needle is a size 20 to 21. 20. The drug delivery device according to claim 17 or claim 18, wherein the needle is smaller than a size 25.21. The drug delivery device of claim 17 or claim 18, wherein the needle is a gauge of 18 to 25. 22. The drug delivery device of any one of claims 17 to 21, wherein the needle has a length of at least 1.5 inches. 23. The drug delivery device of any one of claims 17 to 21, wherein the needle has a length of 1.5 inches to 2 inches. 24. The drug delivery device of any one of claims 17 to 21, wherein the needle has a length of 0.75 inches to 2.25 inches. 25. The drug delivery device of any one of claims 17 to 24, further comprising a needle protector configured to selectively cover the needle. 26. The drug delivery device of any one of claims 1 to 25, wherein the housing includes at least one vent. 27. The drug delivery device of any one of claims 1 to 26, wherein the gas canister is attached to the plunger rod. 28. The drug delivery device of any one of claims 1 to 27, wherein the gas canister is disposed within the plunger rod. 29. A method of delivering a pharmaceutical agent contained in a container, the method comprising: puncturing a gas canister to release compressed gas to drive a plunger rod and dispense the pharmaceutical agent, wherein the gas canister is configured to travel with the plunger rod. 30. The method of claim 29, wherein puncturing the gas canister comprises pressing a button to activate an element configured to puncture the gas canister. 31. The method of claim 29 or claim 30, further comprising attaching a needle to a distal end of the container. 32. The method of claim 31, wherein attaching the needle to the container moves an interlocking device from a locked position to an unlocked position, wherein the interlocking device prevents the button from moving in the locked position and allows the button to move in the unlocked position. 33. The method of claim 31 or claim 32, wherein attaching the needle to the container comprises screwing a needle seat onto the threads of a container retainer. 34. The method of any one of claims 29 to 33, further comprising discharging the compressed gas from a housing via one or more vent holes. 35. The method of any one of claims 29 to 34, wherein the gas canister is attached to the plunger rod. 36. The method according to any one of claims 29 to 35, wherein the gas canister is disposed within the plunger rod. Claims 2 / 3 pages 3 CN 121909055 A 37. A kit comprising: a drug delivery device according to any one of claims 1 to 28; and a needle. 38. The kit according to claim 37, wherein the needle is configured to attach to the drug delivery device.39. The kit of claim 37, wherein the kit comprises a plurality of needles. 40. The kit of claim 39, wherein the needles have different sizes. 41. The kit of claim 39 or claim 40, wherein the needles have different shapes. 42. The kit of any one of claims 37 to 41, wherein the needles are configured to attach to the drug delivery device. Claims 3 / 3 Page 4 CN 121909055 A Cross-Reference to Related Applications of Compressed Gas Autoinjector

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 586,999, filed September 29, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to medical injection. Background Art

[0003] Injection generally refers to the act of administering a liquid (e.g., a drug) into a patient's body tissues. Injecting a drug into a patient allows the drug to be absorbed relatively quickly. Summary of the Invention

[0004] This system and method can provide relatively high-volume injection of relatively high-viscosity drugs. For example, in some embodiments, the autoinjector described herein provides a relatively easy-to-use device for injecting 5 ml (mL) volumes of a drug with a viscosity of 3000 centipoise (cP) without requiring a relatively large amount of effort from the user. Typically, the gas canister included in the autoinjector provides sufficient injection force to inject the drug at the desired rate to meet the desired delivery time. Using a gas canister to provide a large injection force reduces the force required by the user to adequately deliver the injection. In some embodiments, the gas canister is included in the plunger rod to reduce the volume of the autoinjector. Generally, autoinjectors with a reduced volume are easier for the user to manage and use than larger autoinjectors. In some embodiments, the autoinjector includes an interlocking device that prevents the autoinjector from firing until the desired time or action, for example, when the needle is attached to the distal end of the autoinjector's syringe barrel.

[0005] In one embodiment, the drug delivery device provided herein includes: a housing; a container disposed within the housing and configured to contain a drug; a plunger slidably disposed within the container; a plunger rod configured to push the plunger through the container to dispense the drug when the container contains the drug; and a gas canister configured to travel with the plunger rod and contain compressed gas, wherein the gas canister is configured to release the compressed gas to drive the plunger rod to dispense the drug from a distal end of the container.

[0006] Some embodiments provided herein incorporate one or more of the following features.

[0007] In some embodiments, the container contains 1 mL to 10 mL of drug.

[0008] In some embodiments, the container contains 2 mL to 8 mL of drug.

[0009] In some embodiments, the container holds 4 mL to 6 mL of the agent.

[0010] In some embodiments, the container holds 5 mL of the agent.

[0011] In some embodiments, the container holds 3 mL to 10 mL of the agent.

[0012] In some embodiments, the agent has a viscosity in the range of 1 cP to 3000 cP.

[0013] In some embodiments, the agent has a viscosity in the range of 1 cP to 2250 cP.

[0014] In some embodiments, the agent has a viscosity in the range of 1750 cP to 2750 cP.

[0015] In some embodiments, the agent has a viscosity in the range of 2000 cP to 2200 cP.

[0016] In some embodiments, the agent has a viscosity of at least 2200 cP.

[0017] In some embodiments, the drug delivery device includes a button configured to activate an element configured to puncture a gas canister, wherein the gas canister is configured to release compressed gas upon puncture.

[0018] In some embodiments, the drug delivery device includes an interlocking device configured to prevent the element from puncturing the gas canister when the interlocking device is in a locked position.

[0019] In some embodiments, the housing includes a cutout configured to receive the interlocking device when it is in an unlocked position.

[0020] In some embodiments, the cutout allows the interlocking device to bend radially when it is in the unlocked position.

[0021] In some embodiments, the housing prevents the interlocking device from bending radially when it is in the locked position.

[0022] In some embodiments, the drug delivery device includes a needle configured to attach to a distal end of a container.

[0023] In some embodiments, the interlocking device is configured to move to an unlocked position when the needle is attached to the drug delivery device.

[0024] In some embodiments, the needle is a size 20 to 21.

[0025] In some embodiments, the needle is smaller than a size 25.

[0026] In some embodiments, the needle is a size 18 to 25.

[0027] In some embodiments, the needle has a length of at least 1.5 inches.

[0028] In some embodiments, the needle has a length of 1.5 inches to 2 inches.

[0029] In some embodiments, the needle has a length of 0.75 inches to 2.25 inches.

[0030] In some embodiments, the drug delivery device includes a needle protector configured to selectively cover the needle.

[0031] In some embodiments, the housing includes at least one vent.

[0032] In some embodiments, a gas canister is attached to the plunger rod.

[0033] In some embodiments, the gas canister is disposed within the plunger rod.

[0034] In another embodiment, this document provides a method for delivering a pharmaceutical agent contained in a container, the method comprising puncturing a gas canister to release compressed gas to drive a plunger rod and dispense the pharmaceutical agent, wherein the gas canister is configured to travel with the plunger rod.

[0035] Some embodiments provided herein include one or more of the following features.

[0036] In some embodiments, puncturing the gas canister includes pressing a button to activate an element configured to puncture the gas canister.

[0037] In some embodiments, the method includes attaching a needle to a distal end of the container.

[0038] In some embodiments, attaching the needle to the container causes an interlocking device to move from a locked position to an unlocked position, wherein the interlocking device prevents the button from moving in the locked position and allows the button to move in the unlocked position.

[0039] In some embodiments, attaching the needle to the container includes screwing a needle seat onto the threads of a container retainer.

[0040] In some embodiments, the method includes discharging compressed gas from the housing via one or more vents.

[0041] In some embodiments, the gas canister is attached to the plunger rod.

[0042] In some embodiments, the gas canister is disposed within the plunger rod.

[0043] In one embodiment, a kit is provided herein that includes a drug delivery device according to any of the above embodiments. The kit also includes needles.

[0044] In some embodiments, the needles are configured to attach to the drug delivery device. Specification 2 / 9 pages 6 CN 121909055 A

[0045] In some embodiments, the kit includes a plurality of needles.

[0046] In some embodiments, the needles have different sizes.

[0047] In some embodiments, the needles have different shapes.

[0048] In some embodiments, the needles are configured to attach to the drug delivery device.

[0049] Details of one or more embodiments of the subject matter described herein are set forth in the following drawings and description. Other features, objects, and advantages of the subject matter will be apparent from the description and drawings and the claims. Brief Description of the Drawings

[0050] FIG1 shows an example autoinjector.

[0051] FIG2 shows the internal components of an example autoinjector.

[0052] FIG3 shows a gas canister disposed within the plunger.

[0053] Figures 4A to 4C illustrate an interlocking device to prevent accidental firing of the autoinjector.

[0054] Figure 5 illustrates the needle attached to the autoinjector.

[0055] Figures 6A and 6B illustrate an unlocking interlocking device that allows firing of the autoinjector.

[0056] Figures 7A to 7C illustrate the movement of the interlocking device that allows firing of the autoinjector.

[0057] Figures 8A and 8B illustrate firing of the autoinjector.

[0058] Figure 9 illustrates a needle safety cap covering the needle.

[0059] Figure 10 is a table of delivery time versus force for high-viscosity pharmaceuticals.

[0060] The same reference numerals and names in the various figures indicate the same elements. Detailed Description

[0061] In some embodiments, the systems and methods provided herein provide relatively high-volume injections of relatively high-viscosity pharmaceuticals and provide relatively large injection forces while reducing the force applied by the user to adequately deliver the injection. In some embodiments, the systems and methods also prevent the firing of the autoinjector until a desired time or action, e.g., when the needle is attached to the autoinjector.

[0062] Figure 1 illustrates an example autoinjector 100, which includes a housing 102, a button 104 on a proximal end 106 of the housing 102, and a needle holder 108 attached to a distal end 110 of the housing 102. The needle holder 108 includes a needle safety device 112 that can selectively cover the needle 114 of the needle holder 108. For example, a user can bend the needle safety device 112 about the hinge 116 to move the needle safety device 112 over the needle 114. The needle 114 is covered by a needle cap 118, which the user removes before using the autoinjector 100. In some embodiments, the button 104 is located at other locations on the autoinjector. For example, the button 104 may be a side button located somewhere between the proximal end 106 and the distal end 110 of the housing 102. In some embodiments, the button is a lever that rotates relative to the housing 102 to activate the device. In some embodiments, the housing 102 includes a flange configured to receive the user's finger.

[0063] The housing 102 includes a label 122 that provides information about the autoinjector 100. For example, in some embodiments, the label 122 includes medication information such as the type of medication, the dosage, the delivery time of the dosage, the expiration date of the medication, the batch or lot number, information identifying the autoinjector 100 as a single-use autoinjector, and company information. Optionally, the housing 102 does not include the label 122.

[0064] The housing 102 also includes a window 120 through which the user can see the medication contained within the autoinjector 100, for example, the medication contained in the container of the autoinjector 100 (see discussion below). In some embodiments, the window 120 helps the user determine whether the autoinjector 100 has been used. Before using the autoinjector 100, the user can see through the window 120 to determine whether there is medication inside the autoinjector 100, for example, to determine whether the autoinjector has not been used. In some embodiments, during use of the autoinjector 100, the user can see through the window 120 to determine whether the volume of medication in the autoinjector 100 is decreasing.In some embodiments, after using the autoinjector 100, the user sees through window 120 to determine that there is no medication in the autoinjector 100, for example, to determine that the autoinjector 100 has been used. In some embodiments, the user sees the plunger through window 120 and determines that the autoinjector 100 has been used. In some embodiments, the user determines that the autoinjector has been used because button 104 remains in the use position.

[0065] In some embodiments, the autoinjector 100 is used for intramuscular injection, which is injected into the patient's muscle. Intramuscular injection may involve a longer and / or thicker needle than subcutaneous injection, which is guided into the fatty tissue between the patient's skin and muscle. As an example, in some embodiments, needle 114 is 20 gauge and 1.5 inches long. As another example, in some embodiments, needle 114 is 27 gauge and 0.5 inches long. Injecting medication with a longer needle may involve a relatively large injection force compared to injecting medication with a shorter needle, for example when the medication is a high-volume, high-viscosity medication. Similarly, injecting a drug through a finer needle may involve a relatively large injection force compared to injecting a drug through a wider needle. For example, intramuscular injection of high-volume, high-viscosity drugs may be relatively difficult due to the relatively large injection force and delivery time involved. In some embodiments, the autoinjector 100 (and other autoinjectors described herein) provides sufficient injection force to inject relatively high-volume, relatively high-viscosity drugs through a needle configured for intramuscular injection within the delivery time described below. The needle may have various sizes for intramuscular injection (e.g., 20 to 21 gauge, smaller than 25 gauge, 18 to 25 gauge, etc.). The needle may also have various lengths for intramuscular injection (e.g., at least 1.5 inches, 1.5 to 2 inches, 1 to 2 inches, 0.75 to 2.25 inches, etc.). In some embodiments, the kit includes the autoinjector 100 and multiple needles. The multiple needles may be of different sizes, different gauges, different shapes, etc., and the user can select a needle suitable for a specific injection. The user can attach a selected needle to the autoinjector 100 and use the autoinjector 100 as described herein.

[0066] FIG2 illustrates an example autoinjector 200 that can provide a relatively large injection force to inject a relatively high volume, relatively high viscosity agent (e.g., similar to the autoinjector 100 of FIG1) through a needle 234 configured for intramuscular injection. The autoinjector 200 includes a housing 202, a container 204 held within the housing 202, a plunger 206 slidably disposed within the container 204, a piston 208, and a gas canister 210. The container 204 is held in a container holder 212 connected to the housing 202.Container 204 can contain a medication (not shown), and the auto-injector 200 can be activated by a user to dispense the medication from container 204. For example, the user can press button 214 on the proximal end 226 of housing 202 to puncture gas canister 210, thereby releasing compressed gas from gas canister 210. The compressed gas may include, for example, argon, carbon dioxide, krypton, xenon, etc. Button 214 is biased in the proximal direction by button spring 218. Button 214 activates firing pin 216, which punctures the end of gas canister 210, as discussed further below. The compressed gas expands, driving piston 208 against plunger 206 and through container 204. As plunger 206 moves distally through container 204, the medication is dispensed through needle 234. When the medication is a relatively high viscosity medication (e.g., 3000 cP), the plunger 206 can provide a relatively large force (e.g., 380 Newtons (N), which may be a time-averaged force) to dispense the medication from the needle 234 within the desired delivery time (e.g., within 50 seconds). A rapidly expanding gas (e.g., released from the gas canister 210) can provide the necessary force, for example, for intramuscular injection. For example, in some embodiments, a rapidly expanding gas, such as that described with respect to the autoinjector 200, can provide a greater force than that provided in an autoinjector using a drive spring.

[0067] As an example, in some embodiments, the container 204 has an internal volume that holds 5 mL of medication. In some embodiments, as described on pages 4 / 9 of a specification (CN 121909055 A), the container 204 holds various volumes of medication (e.g., 1 mL to 10 mL, 2 mL to 8 mL, 4 mL to 6 mL, 3 mL to 10 mL, etc.).

[0068] In the autoinjector 200, a gas canister 210 is disposed within a piston 208. For example, the piston 208 includes a plunger rod portion 220 and a canister retainer portion 222. The plunger rod portion 220 is configured to interact with a plunger 206 to drive the plunger 206 through a container 204. This interaction may include inserting a distal end of the plunger rod portion 220 into a cavity defined within the plunger 206. The canister retainer portion 222 provides a recess to receive the gas canister 210 within it. A seal 224 seals the connection between the plunger rod portion 220 and the canister retainer portion 222, and seals the other end of the canister retainer portion 222. When the gas canister 210 releases compressed gas, the seal 224 prevents the released gas from leaving other portions of the piston 208. The released gas is directed proximally such that the force of the expanding gas drives the piston 208 distally to dispense the medication. Pressure vessel 228 is connected to container retainer 212 and keeps piston 208 aligned with container 204. Released gas expands within pressure vessel 228 to drive piston 208 and plunger 206 into container 204.

[0069] The placement of the gas canister 210 within the piston 208 reduces the volume of the autoinjector 200. For example, if the gas canister were not placed within the piston, the housing would need to extend beyond the piston 208 by at least the length of the gas canister 210 to provide sufficient space for it. Instead, because the length of the gas canister 210 is incorporated into the piston 208, the housing 202 does not need to extend beyond the piston 208 by the additional length of the gas canister 210. In some embodiments, the gas canister is partially (e.g., at least partially) placed within the piston. Reducing the volume of the autoinjector 200 is advantageous because an autoinjector with a reduced volume is easier for the user to manage and use than a bulkier, larger autoinjector.

[0070] The autoinjector 200 also includes a needle hub 230 detachably connected to the distal end of the container 204. The needle hub 230 includes a needle safety device 232 that can selectively cover the needle 234 of the needle hub 230 (e.g., similar to the needle hub 108 of FIG. 1). The needle 234 is covered by a needle cap 236, which the user removes before using the autoinjector 200. The needle hub 230 also includes a needle hub seal 238 that seals the connection between the needle hub 230 and the container 204. The needle hub seal 238 prevents leakage between the container 204 and the needle hub 230.

[0071] In some embodiments, the autoinjector cap 240 is attached to the distal end of the housing 202 before the needle hub 230 is attached to the distal end of the container 204. For example, to use the autoinjector 200, the user can remove the autoinjector cap 240 from the distal end of the autoinjector 200 and then attach the needle hub 230 to the distal end of the container 204. The user can then press button 214 to dispense the medication, as discussed above. In some embodiments, the autoinjector cap 240 includes a Luer point 242 that seals the distal end of the container 204. The Luer cap 242 reduces (e.g., prevents) leakage from the distal end of the container 204 before use of the autoinjector 200. In some embodiments, the Luer cap 242 is configured to be releasably attached to a corresponding Luer tip disposed on the distal end of the container 204.

[0072] The autoinjector 200 may also include an interlocking device 244 to prevent the button 214 from being pressed before the needle seat 230 is attached to the container 204. The interaction between the interlocking device 244 and the button 214 will be described in more detail below. Before use of the device, the interlocking device 244 is biased in a locked position in the distal direction by an interlocking device spring 246. For example, the interlocking device spring 246 may be disposed between the housing 202 and the interlocking device 244 to bias the interlocking device 244 in the distal direction. When the interlocking device 244 is in the locked position, the interlocking device 244 prevents the button 214 from being pressed, as discussed further below.Because interlocking device 244 prevents button 214 from being pressed, firing pin 216 cannot pierce gas canister 210 to dispense medication. When needle seat 230 is attached to container 204, needle seat 230 overcomes the bias of interlocking device spring 246 to move interlocking device 244 to the unlocked position. When interlocking device 244 is in the unlocked position, interlocking device 244 allows button 214 to be pressed, as discussed further below. Because interlocking device 244 allows button 214 to be pressed (after needle seat 230 is attached to container), firing pin 216 is able to pierce gas canister 210 to dispense medication through needle seat 230. Specification 5 / 9 pages 9 CN 121909055 A

[0073] Figure 3 shows an example of pressure vessel 300. Pressure vessel 300 may be similar to pressure vessel 228 of Figure 2. Pressure vessel 300 is connected to container holder 302 to keep piston 304 aligned with container 306. Piston 304 includes a gas canister 308 disposed within piston 304. For example, piston 304 includes a plunger rod portion 310 and a canister portion 312. The plunger rod portion 310 is configured to interact with a plunger 314 to drive the plunger 314 through container 306. Canister portion 312 provides a recess to receive gas canister 308 within canister portion 312.

[0074] In some embodiments, pressure vessel 300 includes one or more piston seals 316 that seal the connection between plunger rod portion 310 and canister portion 312. Piston seal 316 may be formed of, for example, nitrile rubber (e.g., having a Shore A hardness of 70). Piston seal 316 prevents gas released from gas canister 308 from escaping via the connection between plunger rod portion 310 and canister portion 312. In some embodiments, one or more piston seals 316 are static seals. For example, a static seal may form a seal between components that do not move relative to each other. In some embodiments, there is no seal between the plunger rod portion 310 and the canister portion 312. For example, the plunger rod portion 310 and the canister portion 312 may be formed as a single piece, such that there is no connection between the plunger rod portion 310 and the canister portion 312 for gas venting. When the plunger rod portion 310 and the canister portion 312 are two connected pieces, one or more piston seals 316 can prevent gas from venting via the connection between the plunger rod portion 310 and the canister portion 312.

[0075] In some embodiments, the pressure vessel 300 also includes one or more lip seals 318 that seal the area between the piston 304 and the pressure vessel 300. The lip seals 318 may be formed of, for example, nitrile rubber (e.g., having a Shore A hardness of 75 or 85). The lip seals 318 prevent gas from escaping around the piston 304 and entering the container 306. Keeping the expanding gas close to the piston 304 drives the piston 304 distally.If gas can escape around piston 304, piston 304 may not be sufficiently driven distally to dispense the agent. A lip seal 318 can retain the expanding gas close to piston 304 by sealing the area between piston 304 and pressure vessel 300. In some embodiments, one or more lip seals 318 are dynamic seals. For example, a dynamic seal can form a seal between components that move relative to each other.

[0076] In some embodiments, pressure vessel 300 also includes one or more striker seals 320 that seal the area between pressure vessel 300 and a striker 322 that pierces gas canister 308. The striker seal 320 can be formed of, for example, an elastomer (e.g., a fluoropolymer, such as Viton™, having a Shore A hardness of 70). The striker seal 320 can be formed of rubber. The striker seal 320 prevents gas from escaping through the rear of pressure vessel 300. Retaining the expanding gas within pressure vessel 300 provides a defined volume for the gas to expand therein. A defined volume is provided for the gas to expand within which the force exerted on piston 304 by the expanding gas is controlled. For example, if the expanding gas is not limited to a defined volume, the gas may not exert the desired injection force on piston 304. The firing pin seal 320 can retain the expanding gas within a defined volume of pressure vessel 300 by sealing the area between pressure vessel 300 and firing pin 322. In some embodiments, one or more firing pin seals 320 are dynamic seals.

[0077] Figures 4A through 4C illustrate an autoinjector 200 with interlocking device 244 in a locked position and cap 240 removed by the user before using the autoinjector 200. Removing cap 240 from the autoinjector 200 allows a needle hub (not shown) to be attached to the autoinjector 200, as discussed above.

[0078] Interlocking device 244 is biased to the locked position in the distal direction by interlocking device spring 246. For example, an interlocking spring 246 may be disposed between the housing 202 and the interlocking device 244 to bias the interlocking device 244 in a distal direction. When the interlocking device 244 is in the locked position, it prevents the button 214 from being pressed. For example, the interlocking device 244 includes an interlocking device latch 248 that interacts with a button latch 250 to prevent the button 214 from being pressed. When a user attempts to press the button 214, for example, as shown by arrow F in FIG4B, the interlocking device latch 248 interacts with the button latch 250 and prevents the button 214 from moving to a position sufficient to cause the firing pin 216 to pierce the gas canister 210. For example, FIG4C shows a closer view of the firing pin 216, which cannot pierce the gas canister 210.

[0079] In some embodiments, when the interlocking device 244 is in the locked position, the button 214 is capable of moving a relatively small distance (e.g., 2 mm). This relatively small distance is still insufficient for the firing pin 216 to pierce the gas canister 210. The button spring 218 can bias the button 214 away from the interlocking device 244 in a proximal direction.

[0080] In some embodiments, the pressure vessel 228 includes a protrusion 252 to prevent the button latch 250 from being biased inward away from the interlocking device latch 248 and from moving past the interlocking device latch 248 when the interlocking device 244 is in the locked position. In some embodiments, the button latch 250 is not flexible and cannot be biased inward, and the protrusion 252 is optional.

[0081] FIG5 shows a needle holder 230 attached to an autoinjector 200. For example, a user can attach the needle holder 230 to the autoinjector 200. Attaching the needle holder 230 to the autoinjector 200 can move the interlocking device from the locked position to the unlocked position, as discussed above. In the example shown, the needle hub 230 is rotated to attach to the autoinjector 200, for example, via a threaded connection. In some embodiments, the needle hub 230 is attached to the autoinjector via other connections (e.g., bayonet connections, snap-fit ​​connections, etc.). The needle hub 230 may be connected to the container 204 of the autoinjector 200, as discussed above. The rotation of the needle hub 230 is indicated by arrow 254 in a clockwise direction. In some embodiments, the needle hub 230 is rotated 90° to attach the needle hub 230 to the autoinjector 200. The needle hub 230 may be designed such that the needle hub can be rotated by various amounts (e.g., 180°, 270°, 360°, etc.) to attach the needle hub 230 to the autoinjector 200.

[0082] Figures 6A and 6B show an autoinjector 200 with an interlocking device 244 that has been moved to an unlocked position due to the attachment of the needle hub 230. As discussed above, attaching the needle hub to the autoinjector moves the interlocking device proximally to the unlocked position. The proximal movement of the interlocking device 244 is indicated by arrow 258. When the interlocking device 244 is in the unlocked position, the button 214 can be pressed, causing the firing pin 216 to pierce the gas canister 210 to dispense the medication. As shown in Figure 6B, the user can press the button 214, causing the button latch 250 of the button 214 to move through the interlocking device latch 248. The pressing of the button is indicated by arrow 260. When the button 214 is pressed, the button spring 218 is pressed, and the button latch 250 moves through the interlocking device latch 248. The button latch 250 is able to move through the interlocking device latch 248 because the interlocking device latch 248 is radially deflected outward through a cutout 256 in the housing 202. The radial deflection of the interlocking device latch 248 is indicated by arrow 262.When the interlocking device 244 moves proximally to the unlocked position, the interlocking device latch 248 aligns with the cutout 256 in the housing 202 to allow the interlocking device latch 248 to deflect outward. As the interlocking device latch 248 deflects radially outward through the cutout 256, the push-button latch 250 has space to move through the interlocking device latch 248, allowing the firing pin 216 to pierce the gas canister 210. For example, Figure 6B shows the firing pin 216 piercing the gas canister 210. As discussed above, expanding gas can provide a large injection force to inject high-volume, high-viscosity agents through a needle configured for intramuscular injection.

[0083] Figures 7A to 7C show the interlocking device latch 248, the push-button latch 250, and the cutout 256 in the housing 202 when the interlocking device 244 is in the locked position and when the interlocking device 244 is in the unlocked position. Figure 7A shows the interlocking latch 248, button latch 250, and cutout 256 when the interlocking device 244 is in the locked position (e.g., before the needle hub 230 is attached to the autoinjector 200). When the interlocking device 244 is in the locked position, the interlocking latch 248 is not aligned with the cutout 256 in the housing 202. Therefore, the housing 202 prevents the interlocking latch 248 from deflecting radially outward. Because the interlocking latch 248 cannot deflect radially outward, the interlocking latch 248 prevents the button latch 250 from moving distally.

[0084] Figure 7B shows the interlocking latch 248, button latch 250, and cutout 256 when the interlocking device 244 is in the unlocked position. For example, as discussed above, when the needle hub 230 is attached to the autoinjector 200, the interlocking device 244 moves proximally from the locked position to the unlocked position. The interlocking device 244 moves proximally to the unlocked position, aligning the interlocking device latch 248 with the cutout 256 in the housing 202. When the interlocking device latch 248 is aligned with the cutout 256, the interlocking device latch 248 can be radially deflected outward. The tilted engagement between the push-button latch 250 and the interlocking device latch 248 causes the interlocking device latch 248 to be radially deflected outward. The outward deflection of the interlocking device latch 248 is indicated by arrow 262. Because the interlocking device latch 248 is aligned with the cutout 256, the housing 202 does not prevent the interlocking device latch 248 from being radially deflected outward. Because the interlocking device latch 248 can be radially deflected outward, the interlocking device latch 248 does not prevent the push-button latch 250 from moving distally.

[0085] Figure 7C shows the interlocking device latch 248, the button latch 250, and the cut 256 when the button latch 250 moves past the interlocking device latch 248. Because the needle hub 230 is connected to the autoinjector 200, the interlocking device latch 248 is aligned with the cut 256.Button latch 250 passes through interlocking latch 248, and the movement of button latch 250 is indicated by arrow 264. Due to the movement of button latch 250, interlocking latch 248 now approaches button latch 250. Interlocking latch 248 prevents button latch 250 from moving proximally after injection begins. Preventing proximal movement of button latch 250 prevents button 214 from moving proximally after injection begins. The engagement between interlocking latch 248 and button latch 250 is not an oblique engagement, so button latch 250 does not cause interlocking latch 248 to deflect radially outward. As button latch moves past interlocking latch 248, firing pin 216 punctures gas canister 210, as discussed above. As discussed above, expanding gas can provide a large injection force to inject high-volume, high-viscosity agents through a needle configured for intramuscular injection.

[0086] Figures 8A and 8B illustrate an autoinjector 200 dispensing medication after the button latch 250 moves past the interlocking latch 248. As discussed above and shown in Figure 8A, the firing pin 216 pierces the gas canister 210. Piercing the gas canister 210 causes compressed gas to expand into the pressure vessel 228, driving the piston 208 distally to dispense medication, as discussed above. The rapid expansion of the compressed gas provides sufficient injection force to inject a high volume, high viscosity liquid within the desired injection time. Figure 8B shows the piston 208 moving into the container 204 to dispense medication. The movement of the piston 208 is indicated by arrow 268.

[0087] In some embodiments, the autoinjector 200 includes a dose initiation click feature 266 that produces an audible sound when the firing pin 216 pierces the gas canister 210. For example, the clicking feature 266 can emit an audible sound when the piston 208 compresses the clicking feature 266. An audible sound can help, for example, warn the user that the gas canister 210 has been punctured. In some embodiments, the clicking feature 266 can emit an audible sound when the dose is fully dispensed. In some embodiments, the clicking feature 266 can emit a continuous clicking sound during dose dispensing.

[0088] In some embodiments, the autoinjector 200 includes a plurality of vents 270 that allow compressed gas to escape from the autoinjector 200 after the dose has been fully dispensed. For example, the pressure vessel 228, the interlocking device 244, and the housing 202 may include vents 270. The location of the vents 270 allows compressed air to push the piston 208 through the container 204, and the vents 270 do not allow gas to escape during dispensing. For example, the vents 270 are not accessible to expanding gas until the piston has moved to the distal position of the dose end. Gas can only reach the vent 270 when the piston 208 reaches the distal position of the dose end.

[0089] Figure 9 shows the needle seat 230 after the dose has been dispensed, as described above.In some embodiments, the user can move the needle safety device 232 to cover the needle 234 by bending the needle safety device 232 about a hinge. The movement of the needle safety device 232 over the needle 234 is indicated by arrow 272. Covering the needle 234 with the needle safety device 232 can prevent accidental needle pricks after the dose is dispensed.

[0090] Figure 10 shows an example table of forces and delivery times for delivering high-volume, high-viscosity medications using the above-described autoinjector 200. High-viscosity medications can have a viscosity of, for example, 2250 cP. In some embodiments, the medication can have a variety of viscosities (e.g., 1 cP to 3000 cP, 1 cP to 2250 cP, 1750 cP to 2750 cP, 2000 cP to 2500 cP, at least 2200 cP, etc.). The viscosity of the medication can also vary depending on the temperature of the medication. For example, the viscosity of the medication at 18°C ​​can be higher than that at 28°C. In one example, the viscosity of the agent may be 2220 cP at 18°C, 1330 cP at 23°C, and 800 cP at 28°C. The force provided by the compressed gas can be designed to meet the desired delivery time for the modified agent's viscosity. The values ​​in Figure 10 are exemplary values ​​for an agent with a viscosity of 2220 cP at 18°C, 1330 cP at 23°C, and 800 cP at 28°C. Calculate the values ​​for a needle length of 2 inches, a needle size of 20, an agent volume of 5 mL, and a container radius of 5.93 mm. A relatively low injection force (e.g., an average force of 140 N) provides a maximum delivery time of 142 seconds (e.g., when the agent's viscosity is 2220 cP at 18°C) and a minimum delivery time of 50 seconds (e.g., when the agent's viscosity is 800 cP at 28°C). A relatively moderate injection force (e.g., an average force of 230 N) provides a maximum delivery time of 83 seconds (e.g., when the viscosity of the agent is 2220 cP at 18°C) and a minimum delivery time of 30 seconds (e.g., when the viscosity of the agent is 800 cP at 28°C). A relatively high injection force (e.g., an average force of 380 N) provides a maximum delivery time of 50 seconds (e.g., when the viscosity of the agent is 2220 cP at 18°C) and a minimum delivery time of 18 seconds (e.g., when the viscosity of the agent is 800 cP at 28°C). Therefore, if the desired maximum delivery time is 50 seconds, the gas canister should apply an average injection force of 380 N to meet the desired delivery time.

[0091] Several embodiments have been described. However, it should be understood that various changes and modifications may be made without departing from the spirit and scope of this disclosure. Therefore, other embodiments are within the scope of the following claims.Instruction manual page 9 / 9, page 13, CN 121909055 A, Figure 1; Instruction manual figure 1 / 13, page 14, CN 121909055 A, Figure 2; Instruction manual figure 2 / 13, page 15, CN 121909055 A, Figure 3; Instruction manual figure 3 / 13, page 16, CN 121909055 A, Figure 4A; Instruction manual figure 4 / 13, page 17, CN 121909055 A, Figure 4B; Instruction manual figure 4C; Instruction manual figure 5 / 13, page 18, CN 121909055 A, Figure 5; Instruction manual figure 6 / 13, page 19, CN 121909055 A, Figure 6A; Instruction manual figure 7 / 13, page 20, CN 121909055 A, Figure 6B; Instruction manual figure 8 / 13, page 21, CN 121909055 A, Figure 7A+7B+7C; Instruction manual figure 9 / 13, page 22, CN. 121909055 A Figure 8A Instruction Manual Appendix 10 / 13 Page 23 CN 121909055 A Figure 8B Instruction Manual Appendix 11 / 13 Page 24 CN 121909055 A Figure 9 Instruction Manual Appendix 12 / 13 Page 25 CN 121909055 A Figure 10 Instruction Manual Appendix 13 / 13 Page 26 CN 121909055 A.

Claims

1. A drug delivery device, comprising: case; A container, which is disposed within the housing and configured to contain a pharmaceutical agent; A plunger, which is slidably disposed within the container; A plunger rod configured to push a plunger through the container to dispense the medication when the container contains the medication; and A gas canister configured to travel with the plunger rod and contain compressed gas, wherein the gas canister is configured to release the compressed gas to drive the plunger rod to dispense the agent from the distal end of the container.

2. The drug delivery device according to claim 1, wherein the container contains 1 mL to 10 mL of drug.

3. The drug delivery device according to claim 1 or claim 2, wherein the container contains 2 mL to 8 mL of drug.

4. The drug delivery device according to any one of claims 1 to 3, wherein the container contains 4 mL to 6 mL of drug.

5. The drug delivery device according to any one of claims 1 to 4, wherein the container contains 5 mL of drug.

6. The drug delivery device according to any one of claims 1 to 2, wherein the container contains 3 mL to 10 mL of drug.

7. The drug delivery device according to any one of claims 1 to 6, wherein the drug has a viscosity in the range of 1 cP to 3000 cP.

8. The drug delivery device according to any one of claims 1 to 7, wherein the drug has a viscosity in the range of 1 cP to 2250 cP.

9. The drug delivery device according to any one of claims 1 to 8, wherein the drug has a viscosity in the range of 1750 cP to 2750 cP.

10. The drug delivery device according to any one of claims 1 to 9, wherein the drug has a viscosity in the range of 2000 cP to 2200 cP.

11. The drug delivery device according to any one of claims 1 to 10, wherein the drug has a viscosity of at least 2200 cP.

12. The drug delivery device according to any one of claims 1 to 11, further comprising a button configured to activate an element configured to puncture the gas canister, wherein the gas canister is configured to release the compressed gas upon puncture.

13. The drug delivery apparatus according to any one of claims 1 to 12, further comprising an interlocking device configured to prevent the element from puncturing the gas canister when the interlocking device is in a locked position.

14. The drug delivery device of claim 13, wherein the housing includes a cutout configured to receive the interlocking device when the interlocking device is in the unlocked position.

15. The drug delivery device of claim 14, wherein the cut allows the interlocking device to bend radially when the interlocking device is in the unlocked position.

16. The drug delivery device according to any one of claims 13 to 15, wherein when the interlocking device is in the locked position, the housing prevents the interlocking device from bending radially.

17. The drug delivery device according to any one of claims 1 to 16, further comprising a needle configured to be attached to a distal end of the container.

18. The drug delivery device of claim 17, wherein the interlocking device is configured to move to an unlocked position when the needle is attached to the drug delivery device.

19. The drug delivery device according to claim 17 or claim 18, wherein the needle is a size 20 to 21.

20. The drug delivery device according to claim 17 or claim 18, wherein the needle is smaller than size 25.

21. The drug delivery device according to claim 17 or claim 18, wherein the needle is of size 18 to 25.

22. The drug delivery device according to any one of claims 17 to 21, wherein the needle has a length of at least 1.5 inches.

23. The drug delivery device according to any one of claims 17 to 21, wherein the needle has a length of 1.5 inches to 2 inches.

24. The drug delivery device according to any one of claims 17 to 21, wherein the needle has a length of 0.75 inches to 2.25 inches.

25. The drug delivery device according to any one of claims 17 to 24, further comprising a needle protector configured to selectively cover the needle.

26. The drug delivery device according to any one of claims 1 to 25, wherein the housing includes at least one vent.

27. The drug delivery device according to any one of claims 1 to 26, wherein the gas canister is attached to the plunger rod.

28. The drug delivery device according to any one of claims 1 to 27, wherein the gas canister is disposed within the plunger rod.

29. A method for delivering a pharmaceutical agent contained in a container, the method comprising: The gas canister is punctured to release compressed gas to drive a plunger rod and dispense the medication, wherein the gas canister is configured to travel with the plunger rod.

30. The method of claim 29, wherein piercing the gas canister comprises pressing a button to activate an element configured to pierce the gas canister.

31. The method of claim 29 or claim 30, further comprising attaching the needle to the distal end of the container.

32. The method of claim 31, wherein attaching the needle to the container moves the interlocking device from a locked position to an unlocked position, wherein the interlocking device prevents the button from moving in the locked position and allows the button to move in the unlocked position.

33. The method of claim 31 or claim 32, wherein attaching the needle to the container comprises screwing the needle seat onto the threads of the container retainer.

34. The method according to any one of claims 29 to 33, further comprising discharging the compressed gas from the housing via one or more vents.

35. The method according to any one of claims 29 to 34, wherein the gas canister is attached to the plunger rod.

36. The method according to any one of claims 29 to 35, wherein the gas canister is disposed within the plunger rod.

37. A reagent kit comprising: The drug delivery device according to any one of claims 1 to 28; and Needle.

38. The kit of claim 37, wherein the needle is configured to attach to the drug delivery device.

39. The kit of claim 37, wherein the kit comprises a plurality of needles.

40. The kit of claim 39, wherein the needles have different sizes.

41. The kit according to claim 39 or claim 40, wherein the needle has a different shape.

42. The kit according to any one of claims 37 to 41, wherein the needle is configured to attach to the drug delivery device.

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