Cartridge-type automatic syringe

Abstract

The present invention is an automatic injector for administering and self-administering medications by subcutaneous, intramuscular, or intradermal injection, and for administering drug solutions or suspensions. The automatic injector may include three modules for ease of assembly, primarily including a standard cartridge module with a stopper and septum, a power supply and indicator module that presses against the cartridge stopper to pressurize the contents, an injection progress indicator, and a needle shuttle consisting of two needles, one of which is an injection needle and the other a septum needle. A needle guard ensures that the needle is always covered, thereby concealing it before and after injection and preventing needlestick injuries after use.

Description

[Technical Field]

[0001] The present invention relates to an auto-injector for administration and self-administration of medicaments by subcutaneous, intramuscular or intradermal injection, and for a medicament solution or suspension. The present application describes an injection system that may be used by a patient or by a healthcare worker for self-injection.

[0002] Auto-injectors automate the injection stroke and eliminate the need for a patient or healthcare worker to actuate a plunger rod.

[0003] The auto-injector according to the present invention comprises an outer casing that holds a standard cartridge comprising a barrel in which medicament contents are enclosed by a movable plunger or stopper at one end, and a seal or septum and a metallic crimp or cap for holding the septum in place at the other end. Biasing means presses against the movable plunger or stopper of the cartridge, thereby pressurizing the medicament contents. A needle shuttle held within the casing comprises two needles mounted and connected to each other, the first needle being an injection needle and the second needle being a septum needle. Means or a shoulder retains the cartridge in its correct position when inserted, and prevents the cartridge from being pressed against the needle shuttle. A needle guard is connected to the casing and is biased outward by means such as a spring so that the needle is always covered by the needle guard, thereby concealing the needle before and after injection.

[0004] The auto-injector according to the present invention may further comprise a needle guard locking mechanism that prevents the needle guard from being pushed back a second time, thereby preventing needle stick injuries after use.

[0005] The automatic syringe may further include an indicator. The indicator may be in the form of an indicator rod attached to a biasing means or a movable plunger or stopper, and moving together with them, thereby indicating the progress of injection. The indicator rod may be connected to and used to operate any other indicator, such as a rotary indicator or an electronic indicator or a connectable device.

[0006] In one embodiment, the indicator extends beyond the rear casing to a distance determined by the filling volume, allowing the user to monitor the injection status.

[0007] In a preferred embodiment, the indicator rod has a closed end containing a spring. The outer casing includes a portion, e.g., a cap with a transparent or viewing window, that allows monitoring of the progress and status of the injection. When the drug volume is completely injected, the indicator is no longer visible, indicating the end of the injection. Placing the spring inside the indicator has the advantage that the spring can be longer than if the indicator were placed inside the spring, allowing the device to be shorter. A longer spring means a larger average force, which is advantageous in the case of viscous drugs.

[0008] The present invention further relates to an automatic syringe designed in a modular manner, comprising a plurality of subassemblies or modules. For ease of assembly, the modular automatic syringe comprises three subassemblies: a cartridge, a power supply and indicator subassembly, and a needle and needle guard subassembly.

[0009] The cartridge subassembly comprises a barrel and a drug volume defined by a plunger and a compressed partition.

[0010] The power supply and indicator assembly comprises a biasing means or spring and an indicator rod held within the rear casing. The present invention enables the cartridge to have a variable filling volume when assembled with the power supply and indicator subassembly.

[0011] To indicate the status and progress of the injection process, an indicator rod may be connected to it so as to move together with a biasing means or spring or movable plunger or stopper during the assembly of the device.

[0012] If the biasing means is a spring, the spring may further include a spring locking member. In this case, the power supply and indicator assembly may further include a second, weaker spring for pressurizing the cartridge contents before injection while the first spring is locked by the spring locking member. The second spring also avoids pressure shock when the second spring is relaxed.

[0013] The needle and needle guard subassembly comprises a front casing that holds a needle shuttle having an injection needle and a septum needle, and holds the shuttle within the casing; a needle guard biased outward by a spring to prevent needle stick injuries; a locking mechanism to prevent the needle guard from being pushed back a second time; and means for holding the cartridge in the correct position when inserted.

[0014] The injection needle and the septum needle may have the same or different diameters or gauges. The injection needle and the septum needle may have the same or different types of bevel tips. For example, to minimize injection time, the septum needle may have a larger diameter or smaller gauge than the injection needle. For simplicity, one needle may be used with two sharp ends or bevels. Different needle gauges and / or bevels can be used to ensure that the injection needle penetrates the injection site before the septum needle penetrates the septum, in order to ensure a complete injection. Injection needle replacement allows for adaptation for subcutaneous, intramuscular, or intradermal injection.

[0015] A modular auto-injector may be assembled in a simple two-step process, such as placing the cartridge in the needle and needle guard subassembly, and then connecting the needle and needle guard subassembly to the power supply and indicator subassembly so that the drug contents in the cartridge are pressurized. If the device is intended for single use, any means of connection to lock the subassemblies of the modular auto-injector together, such as snap-fits, may be used.

[0016] In a preferred embodiment, the modular automatic syringe is reassembled or can be used multiple times. In this case, the needle and needle guard assembly and the power supply and indicator assembly may be connected by bayonet fittings or screws, or hinged to each other to allow for reversible connection. In addition, the biasing means of the power supply and indicator assembly can enable multiple uses, such as an electric motor, a liquefied gas canister, or a spring with means for recompressing itself. Finally, the needle and needle guard assembly is equipped with a seal and a removable needle cap that keeps the needle and cartridge partition sterile at all times.

[0017] Embodiments of the automatic syringe according to the present invention may be assembled under sterile conditions or subjected to final sterilization after assembly.

[0018] If the drugs in the cartridge are small molecules (non-biological), the assembled device may be ultimately sterilized in the blister or pouch using gas, vapor, radiation such as gamma rays, e-beam or anything else.

[0019] When sterilizing devices containing sensitive drug contents such as biological agents, the blister / pouch containing the assembled device shall have at least a portion formed from a gas-permeable material. The device may have gas passages to ensure that the outer surfaces of the needle and cartridge septum are sterilized. The device may then be placed in a gaseous environment such as ethylene oxide or nitrogen dioxide for sterilization.

[0020] To prevent the gas from affecting sensitive drug contents, the cartridge assembly may preferably have gas-impermeable components, particularly plungers / stoppers and septa / caps. The gas used should preferably not be hot, preferably lower than body temperature, preferably below 36°C.

[0021] The device may be supplied as a medical device ready for use, or as a pre-assembled combination product ("kit") for self-assembly by the user.

[0022] Sterilization may be performed before or after assembly, in which case the device is ultimately sterilized. If sterilization is performed before assembly, only the needle and guard subassembly or module 182 need to be sterilized. The assembled device may be ultimately sterilized in a blister or pouch. If the device is sterilized outside the blister, a needle cap and possibly a seal are required. If the device is assembled by the user, the cartridge can be supplied in a blister, or if a blister is not used, the partition needs to be wiped with ethanol before device assembly.

[0023] Table 1 outlines various sterilization options, with options 3-6 allowing for reassembly.

[0024] [Table 1]

[0025] The auto-injector according to the present invention may be used with drug suspensions or solutions and APIs or biologics. If the suspension is unstable due to a tendency to settle, the cartridge needs to be shaken before use for re-mixing.

[0026] The modular design has the advantage that each subassembly can be manufactured separately under individually adapted conditions. Furthermore, the modular design allows for flexibility in manufacturing and enables different auto-injectors to share modules. The modular design also allows for interchangeability of parts, which creates the additional advantage that modules or subassemblies can be exchanged to alter the characteristics of the auto-injector. For example, by exchanging the needle and hub and needle guard assembly, the device can be changed from a subcutaneous auto-injector to an intramuscular or intradermal auto-injector. This also enables the power supply module to be a reusable device. With a modularly designed auto-injector, the cartridge can also be replaced after use or after its service life has expired.

[0027] The present invention enables the manufacture of an auto-injector featuring the use of standard industrial syringe cartridges, a dry needle during storage and various other advantages.

[0028] Specific embodiments of the present invention are described below with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] [Figure 1] Fig. 1 is a diagram showing an auto-injector. [Figure 2] Fig. 2 is a diagram showing an auto-injector in which an indicator rod is attached to a stopper. [Figure 3a] Fig. 3 is a diagram showing the auto-injector during injection. [Figure 3b] Fig. 4 is a diagram showing the auto-injector during injection. [Figure 4] Fig. 5 is a diagram showing the auto-injector after injection is completed. [Figure 5]This is a diagram showing a modular automatic syringe. [Figure 6] This is a three-dimensional diagram of a modular automatic syringe. [Figure 7] This figure shows a subassembly having a locking member. [Figure 8] This figure shows a subassembly with an additional spring. [Figure 9] This figure shows another embodiment. [Figure 10] This figure shows another embodiment. [Figure 11] This figure shows an assembled and ready-to-use autosynergia exposed to a gaseous environment for sterilization. [Figure 12] This is a diagram showing an assembled and ready-to-use automatic syringe. [Figure 13] This is a diagram showing an assembled and ready-to-use automatic syringe.

[0030] Figure 1 shows an automatic syringe 101 according to the present invention. A standard cartridge 102 has a barrel 103 in which a drug solution or suspension 107 inside is confined by a movable plunger or stopper 104 at one end and a rubber seal or partition and a metal crimping portion 105 at the other end. The cartridge 102 is held in a casing 110. A biasing means 112 presses against the stopper 104 and pressurizes the contents 107. A needle shuttle 120 is held in the casing 110. The shuttle 120 has two needles 121 and 122 that are attached to and connected to each other. Needle 121 is an injection needle, and needle 122 is a partition needle. Means 127 hold the cartridge 103 in its correct position when inserted and prevent the cartridge 103 from being pressed against the shuttle. A needle guard 131 and a spring 132 are held in the casing 110. The needle guard 131 is intended to prevent needle stick injuries after injection.

[0031] Figure 2 shows an automatic syringe 101 with an indicator rod 111 attached to a stopper 104.

[0032] Figures 3a and 3b show the auto-injector 101 during injection. The auto-injector 101 is pressed against the injection site 201. The needle 121 is inside the injection site 201 and delivers the drug solution or suspension 107a as a bolus dose. The needle guard 131 is pressed against the injection site 201 and is pushed backward against the casing 110 against a spring 132, pushing the shuttle 120 back. The needle 122 penetrates the septum 105, and the pressurized contents 107 flow into the injection site 201 via needles 121 and 122, delivering the bolus dose 107a. The indicator 111 is moving forward, indicating the progress of the injection. To ensure a complete injection, the injection needle penetrates the injection site (Figure 3a) before the septum needle penetrates the septum (Figure 3b).

[0033] In Figure 4, the automatic syringe 101 has finished injecting, and the needle guard 131 has been pushed back by the spring 132 and locked in place by the locking mechanism 135.

[0034] Figure 5 shows a modular automatic syringe according to the present invention, which consists of three subassemblies: a cartridge subassembly 181, a needle and needle guard subassembly 182, and a power supply and indicator subassembly 183.

[0035] The cartridge subassembly 181 includes a cartridge 102 with a barrel 103, and a drug volume 107 held by a plunger 104 and a partition 105.

[0036] The power supply and indicator subassembly 183 includes a biasing means or spring 112 and an indicator rod 111 held within the casing 110a.

[0037] The needle and needle guard subassembly 182 has a casing 110b, which holds a needle shuttle 120 with needles 121 and 122. A needle guard 131 for preventing needle stick injuries is biased outward by a spring 132. The module 182 may be supplied in a sterile condition. The module 182 also has a guard locking mechanism, i.e., a shoulder 127, which holds the cartridge 102 in its correct position when inserted (not shown).

[0038] Module 182 may include a needle for subcutaneous, intramuscular, or intradermal injection.

[0039] Figure 6 shows a three-dimensional view of a modular auto-injector. After the cartridge 181 is placed in the sub-assembly 182, the sub-assemblies 183 and 182 are locked together in the directions of arrows 187 and 188, pressurizing the drug contents in the cartridge 181.

[0040] The assembled automatic syringe 184 is shown with an additional indicator cap, an indicator knob 111a attached to an indicator rod 111 (not shown), and an additional front cap 141, which are optional features.

[0041] In Figure 7, the subassembly 183a has a locking member 251 which holds the spring 112 in a compressed state by the indicator rod 111 and releases it to simplify the assembly of the device. After the device is assembled, the locking member 251 is slowly removed to release the spring 112 and slowly compress the cartridge contents to avoid pressure shock. The locking member 251 may be a nut or any other mechanism on a threaded indicator rod.

[0042] In Figure 8, subassembly 183b has an additional spring 112b that is weaker than the spring 112 that compresses the drug solution in the cartridge after the device is assembled. Before injection, the locking device 251 is removed, which allows spring 112 to fully pressurize the contents of the cartridge.

[0043] Figure 9 shows another embodiment. For easy assembly, a latch 253 holds the spring 112 in a compressed state and then returns it to its original state. When the device is assembled, the latch 253 releases the spring by the outward axial movement of the indicator 111, compressing the drug contents.

[0044] Figure 10 shows another embodiment of the present invention. Module 186 is a combination of subassemblies 181 and 182, having a cartridge 102 supplied to the user, to which needles 121 and 122 are attached and held in place by the needles 121 and 122.

[0045] Figure 11 shows an assembled and ready-to-use autosyringe placed in a blister or pouch 488 and exposed to a gaseous environment for final sterilization, where 489 indicates the sterilized area.

[0046] Figure 12 shows an assembled and ready-to-use automatic syringe, in which the indicator 111 includes a spring 112 inside and a cap 122 that allows observation of the injection progress.

[0047] Figure 13 is ,needle To maintain a sterile state Additional seal 128 and The image shows an assembled and ready-to-use autosynergy, including an elastomer needle cap 126. The use of the cap 126 and selective seal 128 allows for final sterilization without the use of a blister pack. For easier removal from the needle guard 131, the cap 126 is formed from an elastomer material such as rubber.

[0048] A preferred embodiment of the present invention is: A cartridge subassembly 181 includes a barrel 103 and a drug volume 107 held by a partition wall 105 pressed against a movable plunger or stopper 104, A power supply and indicator subassembly 183 including a rear casing 110a that holds a biasing means 112 and an indicator rod 111, The needle and needle guard subassembly 182 includes a front casing 110b that holds a needle shuttle 120 having an injection needle 121 and a septum needle 122, a needle guard 131 and a spring 132, a locking mechanism 135 that prevents the needle guard 131 from being pushed back a second time, and means or shoulder 127 for holding the cartridge 102 in its correct position when the device is assembled, the assembled device being placed in a blister or pouch 488 and finally sterilized, the needle and needle guard subassembly 182 It is a modular automatic syringe that is ready for use and equipped with [features / equipment].

[0049] Another preferred embodiment of the present invention is, A cartridge subassembly 181 includes a barrel 103 and a drug volume 107 held by a movable plunger or stopper 104 and a partition or cap 105 that is pressed against it, • An indicator assembly 183 including a rear casing 110a and an indicator rod 111 containing a spring 112 inside, A needle and needle guard subassembly 182 comprising a front casing 110b that holds a needle shuttle 120 having an injection needle 121 and a septum needle 122, a needle guard 131 and a spring 132, a locking mechanism 135 that prevents the needle guard 131 from being pushed back a second time, and a shoulder portion 127 that holds the cartridge 102 in the correct position when inserted. ,needle To maintain a sterile state Seal 128 and A needle and needle guard subassembly 182, including a removable elastomer needle cap 126, • Reversible connection means 129 that allow the device to be reassembled and assembled by the user. Equipped with, Assembly 182 is supplied sterile and ready for use in a blister pack and / or with seal 128 and needle cap 126. This is a ready-to-use and reusable modular automatic syringe.

Claims

1. A modular automatic syringe, An outer casing that holds a standard cartridge consisting of a barrel in which the drug contents are enclosed by a movable plunger at one end and a seal and metal crimping portion at the other end, A biasing means that presses the movable plunger of the cartridge to pressurize the contents of the drug, A needle shuttle held within the outer casing, comprising two needles attached to and connected to each other, wherein the first needle is an injection needle and the second needle is a septum needle, Means for holding the cartridge in the correct position when inserted, A needle guard held in the outer casing, the needle guard being biased outward by a spring such that the injection needle is always covered by the needle guard, Equipped with, The outer casing consists of a rear casing that holds the biasing means and a front casing that holds the needle shuttle. The aforementioned modular automatic syringe is Three subassemblies, namely, Cartridge subassembly and Power supply and indicator subassemblies, Needle and needle guard subassembly, Furthermore, The cartridge subassembly consists of the cartridge, The power supply and indicator subassembly includes the rear casing that holds the biasing means, The needle and needle guard subassembly comprises the front casing that holds the needle shuttle having the injection needle and the partition needle, the needle guard and the spring, a locking mechanism that prevents the needle guard from being pushed back a second time, and a shoulder that holds the cartridge in the correct position when inserted. The modular automatic syringe is assembled by inserting the cartridge subassembly into the needle and needle guard subassembly, and then connecting the needle and needle guard subassembly to the power supply and indicator subassembly. A modular automatic syringe.

2. The modular automatic syringe according to claim 1, further comprising an indicator rod attached to the movable plunger.

3. The modular automatic syringe according to claim 2, wherein the indicator rod has a closed end containing the biasing means in the form of a spring inside, and the outer casing has a transparent portion that allows monitoring of the progress and status of the injection.

4. The modular automatic syringe according to any one of claims 1 to 3, wherein the cartridge subassembly comprises the barrel and a drug volume defined by the movable plunger and the crimped partition.

5. The modular automatic syringe according to claim 2 or 3, wherein the power supply and indicator subassembly comprises the biasing means and the indicator rod held within the rear casing.

6. The modular automatic syringe according to claim 5, wherein the indicator rod is connected to the movable plunger so as to move together with the movable plunger.

7. The modular automatic syringe according to claim 5 or 6, wherein the biasing means of the power supply and indicator subassembly is a spring further comprising a spring locking member.

8. The modular automatic syringe according to claim 7, wherein the power supply and indicator subassembly further comprises an additional spring weaker than the spring for pressurizing the drug contents before injection while the spring of the biasing means is locked by the spring locking member.

9. A modular automatic syringe according to any one of claims 1 to 8, for reassembly, wherein the needle and needle guard subassembly further comprises a seal and a needle cap, the biasing means of the power supply and indicator subassembly is an electric motor or a liquefied gas canister or a spring having means for recompressing itself, and the needle and needle guard subassembly and the power supply and indicator subassembly are reversibly connected by bayonet fitting or screw or hinged to each other.

10. A method for assembling a modular automatic syringe according to any one of claims 1 to 9, The steps include inserting the cartridge subassembly into the needle and needle guard subassembly, The steps include connecting the power supply and indicator subassembly to the needle and needle guard subassembly having the inserted cartridge subassembly via connecting means so that the drug contents in the cartridge subassembly are pressurized, Methods that include...

11. The steps include inserting a pre-assembled modular automatic syringe into a blister pack or pouch, The steps include: Exposing the blister or pouch to final sterilization; The method according to claim 10, further comprising:

12. The method according to claim 11, wherein the final sterilization is performed with ethylene oxide or nitrogen dioxide.

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