RU2841007C1 - Button-triggered autoinjector - Google Patents

Abstract

FIELD: medical science.

SUBSTANCE: group of inventions generally refers to button-triggered autoinjectors and, in some embodiments, to button-triggered launchers for delivering large amounts of drug for subcutaneous penetration. According to the first version, the injector comprises the body, the drug container, the button, the stopper, the piston movable in relation to the stopper, and the power source configured to push the piston distally along the long axis. Body has a proximal end and a distal end and extends along a long axis. Drug container comprises a drug volume. Button has a button body, a button opening extending through the button body, a plate extending distally from the proximal end of the button body, and is coupled to the body. Button is rotatable about a longitudinal axis between a locked position and an unlocked position and movable along the longitudinal axis between a pre-start position and a trigger position. Stopper has a stopper body, a crown formed at the proximal end of the stopper body, configured to engage the button plate, and an engagement element extending from the stopper body. Engagement element is movable between an engagement position and a disengagement position, at least partially disposed within the button. Piston displacement relative to retainer is prevented by push-button in pre-start position. Turning the button to the unlocked position aligns the button hole with the engagement member, and turning the button to the unlocked position and moving the button distally along the longitudinal axis, relative to the body, to the starting position enables moving the piston relative to the stopper. According to a second embodiment, the injector also comprises a plunger within the drug container; and a power source configured to push the piston distally along the longitudinal axis. Drug container has a Luer lock extending from its distal end. Stopper is at least partially located inside button. Movement of the piston relative to the stopper is prevented by the button in the pre-starting position, and turning the button into the unlocked position and moving the button distally along the longitudinal axis, relative to the body, into the starting position enables moving the piston relative to the stopper. According to a third embodiment of the injector, the drug container is fixed relative to the body; stopper is fixed relative to the body.

EFFECT: invention is capable of delivering a large dose of the viscous medicament over a delivery time suitable for a manual device.

20 cl, 24 dwg

Description

AREA OF TECHNOLOGY

[0002] The present invention generally relates to push-button triggered autoinjectors and, in some embodiments, push-button triggered devices for delivering large volumes of a drug to penetrate the surface of the skin.

ESSENCE OF THE INVENTION

[0003] In specific embodiments, an injector comprises: a housing having a proximal end and a distal end extending along a longitudinal axis; a drug container containing a volume of drug; a button associated with the housing, where the button is capable of rotating about a longitudinal axis between a locked position and an unlocked position, and movable along the longitudinal axis between a pre-fire position and a fire position; a stopper at least partially located inside the button; a piston movable relative to the stopper; and a power source configured to push the piston distally along the longitudinal axis. In specific embodiments, the piston is prevented from moving relative to the stopper by means of the button in the pre-fire position. In specific embodiments, rotating the button to the unlocked position and moving the button distally along the longitudinal axis, relative to the housing, to the fire position allows the piston to move relative to the stopper.

[0004] In particular embodiments, the button includes a button body, a button opening passing through the button body, and a plate extending distally from a proximal end of the button body. In particular embodiments, the stopper includes a stopper body, a crown formed on the proximal end of the stopper body, having a configuration for engaging the button plate, and an engagement element extending from the stopper body, where the engagement element is configured to move between an engaged position and a disengaged position. In particular embodiments, at least a portion of the plate engages the crown when the button is in a locked position and in an unlocked position.

[0005] In particular embodiments, the piston includes a piston body and a piston opening extending through the piston body, where the piston opening has a configuration for receiving at least a portion of the engagement element when the button is in the pre-fire position. In particular embodiments, the engagement element comprises: a flexible leg extending along the longitudinal axis; and a projection extending radially therefrom. In particular embodiments, the projection extends radially inward from the end of the flexible leg. In particular embodiments, rotation of the button to the unlocked position aligns the button opening with the engagement element. In particular embodiments, distal movement of the button to the fire position allows the engagement element to flex radially outward and pass, at least partially, through the button opening.

[0006] In particular embodiments, the drug container includes a Luer lock extending from its distal end, the injector further includes a plunger located inside the Luer lock. In particular embodiments, the piston engages the plunger, thereby moving the plunger relative to the drug container when the button is moved to the firing position. In particular embodiments, the movement of the plunger relative to the drug container expels a volume of drug from the drug container through the Luer lock.

[0007] In particular embodiments, the injector further comprises: a needle connected to a luer lock, where the needle is in fluid communication with the drug container. In particular embodiments, the injector further comprises: a luer cap with a removable connection to the luer lock in a storage configuration, where the luer cap is fully recessed inside the housing. In particular embodiments, the button is prevented from moving proximally relative to the housing after the button has been moved from the pre-fire position to the fire position. In particular embodiments, the volume of the drug is at least 10 ml. In particular embodiments, the stopper is fixed relative to the housing, and the drug container is fixed relative to the housing.

[0008] In particular embodiments, the present invention relates to a method of delivering a drug to a subject using an injector, wherein the injector comprises a housing having a proximal end and a distal end extending along a longitudinal axis, a drug container containing a volume of drug, a button associated with the housing, wherein the button is rotatable about the longitudinal axis between a locked position and an unlocked position, and movable along the longitudinal axis between a pre-fire position and a fire position, a stop at least partially located within the button, a plunger movable relative to the stop, and a power source configured to push the plunger distally along the longitudinal axis, wherein the method comprises: detaching a luer cap from a luer tip of the drug container using a luer cap remover, wherein the luer cap is fully recessed within the housing; attaching a needle to a luer lock wherein the needle is in fluid communication with a container for the drug; rotating a button to an unlocked position; inserting at least a portion of the needle into the body of a subject; moving the button distally relative to the housing to a firing position; expelling a volume of drug through the needle into the body of the subject; and withdrawing the needle from the body of the subject.

[0009] In specific embodiments, the piston is prevented from moving relative to the stopper by means of a button in the pre-fire position. In specific embodiments, turning the button to the unlocked position and moving the button distally along the longitudinal axis relative to the housing to the fire position allows the piston to move relative to the stopper.

[0010] In particular embodiments, the method may further include: rotating the button to an unlocked position to align the button opening from the button with the engagement element of the stopper. In particular embodiments, the method may further include: moving the button distally to the firing position, thereby allowing the engagement element to flex radially outward and pass, at least partially, through the button opening.

[0011] In particular embodiments, the method may further include: engaging the plunger with the piston located in the drug device, thereby moving the plunger relative to the drug container when the button is moved to the firing position. In particular embodiments, the method may further include: moving the plunger relative to the drug container, pushing a volume of drug from the drug container through the needle. In particular embodiments, the method may further include: preventing the button from moving proximally relative to the housing after the button is moved to the firing position.

BRIEF DESCRIPTION OF DRAWINGS

[0012] The foregoing summary of the invention, as well as the following detailed description of embodiments of a push-button-activated autoinjector, can be better understood when read in conjunction with the accompanying drawings of an illustrative embodiment. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentation shown.

[0013] On the drawings:

[0014] Fig. 1 is a front view of a push-button activated autoinjector in accordance with an illustrative embodiment of the present invention;

[0015] Fig. 2 is a side view of the autoinjector of Fig. 1;

[0016] Fig. 3 is a front sectional view of the autoinjector of Fig. 1;

[0017] Fig. 4 is a side sectional view of the autoinjector of Fig. 1;

[0018] Fig. 5 is a partial and translucent front view of the autoinjector of Fig. 1;

[0019] Fig. 6 is a partial and translucent front view of the autoinjector of Fig. 1;

[0020] Fig. 7 is a partial front sectional view of the autoinjector of Fig. 1 with the button in the pre-fire position;

[0021] Fig. 8 is a partial side sectional view of the autoinjector of Fig. 1 with the button in the pre-fire position;

[0022] Fig. 9 is a partial front sectional view of the autoinjector of Fig. 1 with the button in the firing position;

[0023] Fig. 10 is a partial side sectional view of the autoinjector of Fig. 1 with the button in the firing position;

[0024] Fig. 11 is a front view of the autoinjector button of Fig. 1;

[0025] Fig. 12 is a bottom perspective sectional view of the autoinjector button of Fig. 1;

[0026] Fig. 13 is a top perspective view of the autoinjector stopper of Fig. 1;

[0027] Fig. 14 is a side sectional view of the autoinjector stopper of Fig. 1;

[0028] Fig. 15 is a bottom perspective view of the autoinjector piston of Fig. 1;

[0029] Fig. 16 is a side view of the autoinjector piston of Fig. 1;

[0030] Fig. 17 is a front view of the medication container of the autoinjector of Fig. 1 with a needle attached thereto;

[0031] Fig. 18 is a front sectional view of the drug container of the autoinjector of Fig. 1 with a plunger located therein and a needle attached thereto;

[0032] Fig. 19 is a front view of the front housing of the autoinjector of Fig. 1;

[0033] Fig. 20 is a side view of the front housing of the autoinjector of Fig. 1;

[0034] Fig. 21 is a front view of the luer lock remover of the autoinjector of Fig. 1;

[0035] Fig. 22 is a front view of the needle housing of the autoinjector of Fig. 1;

[0036] Fig. 23A is a front view of a luer lock remover located at the distal end of the autoinjector of Fig. 1;

[0037] Fig. 23B is a front view of the luer cap removed from the autoinjector of Fig. 1;

[0038] Fig. 24A is a front view of the needle and needle sheath inserted into the autoinjector of Fig. 1;

[0039] Fig. 24B is a front view of the needle attached to the autoinjector of Fig. 1; and

[0040] Fig. 24C is a front view of the needle sheath removed from the needle and autoinjector of Fig. 1.

DETAILED DESCRIPTION

[0041] The present invention generally relates to autoinjectors, push-button triggered devices, which are used in the delivery of large volumes of injectable liquid, such as a drug, (e.g., 10 ml or larger doses) to penetrate the surface of the skin (e.g., subcutaneous and intramuscular injections). Devices that deliver large volumes of drug are often subject to configuration limitations as the volume of drug delivery increases, such as spring force limitations and breakage of the syringe container. Due to current configurations of the general design of devices and limitations of biological absorption factors that limit the speed and volume of injection, injection devices are often held for long periods of time, and this often leads to the use of other delivery methods, such as body delivery systems that are attached to the patient during delivery.

[0042] Increasingly, more and more biologics allow for administration to patients at home. However, for many biologics, the large doses and resulting large volume of drug that must be delivered often preclude self-administration due to the length of time required to hold the delivery device in place. Protein hyperconcentration can be used to reduce the injection volume in specific cases, but the resulting drug often has a much higher viscosity than traditional biologics. High-power injectors can allow delivery of these hyperconcentrated proteins. However, the typical design of hand-held injectors only allows for the injection of up to 2.5 ml of viscous drug within 30 seconds.

[0043] By developing enzymes that locally degrade hyaluronan (HA) in the subcutaneous (SC) space, thereby temporarily removing the barrier to fluid flow, it is possible to reduce the traditional limitations of biological absorption factors that limit the rate and volume of injection. Thus, it is possible to deliver higher volumes of viscous drugs. Accordingly, there is a need to provide a hand-held device capable of delivering a high dose (e.g., 3 ml, 5 ml, 10 ml, 20 ml and up to 50 ml) of a viscous drug, in a delivery time suitable for a hand-held device.

[0044] Drug delivery technology for high doses of viscous drug is currently based on the proprietary recombinant human hyaluronidase enzyme PH20 (e.g., rHuPH20; Halozyme, Inc.), which facilitates SC delivery of co-administered therapeutic agents. rHuPH20 acts by degrading HA, which plays a role in the resistance to high fluid flow in the SC space, limiting SC delivery, distribution, and absorption of large volumes of drug. Co-administration of rHuPH20 with injectable therapeutic agents can overcome the time and volume barriers associated with existing SC therapeutic formulations and has been shown to reduce the burden on patients and healthcare providers compared to intravenous formulations. rHuPH20 has countless applications in the modern field of injectable therapeutics by enhancing the distribution and absorption of other injectable drugs, such as in cancer therapies (e.g. trastuzumab and rituximab), in the treatment of immunodeficiency, in subcutaneous urography to improve the resorption of radiocontrast media, and in the delivery of rehydration fluid.

[0045] With reference to the detailed drawings, wherein like reference numerals designate like elements throughout, Fig. 1-24C shows an autoinjector, generally designated 10, in accordance with an illustrative embodiment of the present invention.

[0046] As shown in Fig. 1-4, the injector 10 may include a housing 100, a drug container 102, a button 104, a stopper 106, a plunger 108 and an energy source 110. The housing 100 may have a proximal end and a distal end that extend along a longitudinal axis L. The housing 100 may have a configuration to allow a user to grasp or hold the injector 10. The housing 100 may be shaped to fit the user's hand for one-handed operation. The housing 100 may have a generally oval cross-section to facilitate positioning the injector 10 in the user's hand. The housing 100 may further include a bulge that extends along the longitudinal axis L of the housing (as shown in Fig. 1) to facilitate alignment or positioning of the injector 10 in the user's hand. The housing 100 may substantially accommodate the components shown in Fig. 11-18.

[0047] The housing 100 may comprise a front housing 112 and a rear housing 114. The front housing 112 and the rear housing 114 may be connected together by means of a connection on a hooking element. In some embodiments, the front housing 112 and the rear housing 114 are connected using an adhesive or other suitable means to prevent separation during use of the injector 10. The rear housing 114 may have a generally oval cross-section with open proximal and distal ends. The proximal end of the rear housing 114 may have a generally circular opening that is sized and shaped to allow at least a portion of the button 104 to pass through it. The distal end of the rear housing 114 may have an opening that is sized and shaped to receive at least a portion of the front housing 112 therein. As shown in FIG. 19, the front housing 112 may have a neck 120 extending from its proximal end. The neck 120 may include a neck projection 122 extending radially from it. The neck projection 122 may enter a recess in the rear housing (not shown) when the neck 120 is located in the rear housing 114.

[0048] As shown in Fig. 5, the rear housing 114 may include a status window 116 extending therethrough. The status window 116 may have a generally oval shape and size to display the indicators of the button 104, as described in more detail below. The status window 116 may be located at the proximal end of the rear housing. The status window 116 is shown on the front side of the rear housing 114 in Fig. 1, but it should be understood that the status window 116 may be located on either side of the rear housing 114.

[0049] As shown in Figs. 1 and 19, the front housing 112 may be conical and include a medication window 118 extending therethrough. The medication window 118 may include a transparent film or may be empty. The medication window 118 allows the user to visually inspect the contents of the medication container 102 before, during, and after using the injector 10. In some embodiments, the medication window 118 may include one or more lines or symbols to identify the volume of medication in the medication container 102. The front housing 112 may include a rimmed distal end 124, as shown in Figs. The rimmed distal end 124 may be molded to varying lengths to accommodate different sized needles to provide the proper injection depth.

[0050] In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 7 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 7.5 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 8 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 8.5 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 9 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 9.5 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 10 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 10.5 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 11 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 11.5 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 12 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 12.5 mm of the needle 132 to pass through it. In some embodiments, the rimmed distal end 124 may have a shape and size to allow approximately 13 mm of the needle 132 to pass through it.

[0051] A drug container 102 containing a drug may be located within the housing 100. The drug container 102 may be fixed relative to the housing 100. Within the scope of the invention, the drug may contain drugs, biological agents, solutions, gels, suspensions or other substances that can be delivered via a syringe or a needle, and such terms may be used interchangeably as mentioned in the description and claims. The drug container 102 may be a pre-filled syringe. In some embodiments, the drug container 102 may be an insertable cartridge with a drug. In some embodiments, the drug container 102 may be filled using a vial with a needle or another suitable filling method. In one embodiment, the drug container 102 is one of a pre-filled cartridge, a pre-filled syringe with a fixed needle, a vial, or another container containing an injectable liquid. The drug container 102 has a distal portion and a proximal portion opposite the distal portion.

[0052] As shown in Fig. 17-18, the container for the medicine 102 may comprise a container portion 126 defining a liquid chamber containing the medicine. In one embodiment, the container portion 126 of the container for the medicine 102 has a maximum volume of approximately 10 ml. In one embodiment, the container portion 126 of the medicine container 102 has a maximum volume selected from about: 3 ml, 3.5 ml, 4 ml, 4.5 ml, 5.5 ml, 6 ml, 6.5 ml, 7 ml, 7.5 ml, 8 ml, 8.5 ml, 9 ml, 9.5 ml, 10 ml, 10.5 ml, 11 ml, 11.5 ml, 12 ml, 12.5 ml, 13 ml, 13.5 ml, 14 ml, 14.5 ml, 15 ml, 15.5 ml, 16 ml, 16.5 ml, 17 ml, 17.5 ml, 18 ml, 18.5 ml, 19 ml, 19.5 ml, 20 ml, 25 ml, 30 ml, 35 ml, 4 0 ml, 4.5 ml and 50 ml.

[0053] As shown in Fig. 3, 4 and 18, the container for the drug 102 may further comprise a plunger 128 movable within the container portion 126, relative to the container for the drug 102. Prior to use or firing of the injector 10, the plunger 128 may be positioned at the distal end of the container portion 126. The plunger 128 may seal the drug in the container portion 126. The plunger 128 may be made of a rubber material. In one embodiment, the plunger 128 is made of plastic, butyl rubber, polyisoprene, polytetrafluoroethylene, high density polyethylene or other thermosetting elastomers.

[0054] The flange 130 may extend outwardly from the distal portion of the drug container 102. In one embodiment, the flange 130 is a luer lock. In one embodiment, the flange 130 is a luer lock. As shown in Fig. 3-4, the flange 130 may include a luer cap 134 with a removable connection thereto. The luer cap 134 may be connected to the flange 130 in a storage configuration. The luer cap 134 may be completely located within the housing 100. In one embodiment, the luer cap 134 may be at least partially located within the housing 100.

[0055] In one embodiment, as shown in Fig. 17-18, the flange 130 may be capable of being connected to a needle 132, in fluid communication with a drug in the container portion 126. The needle 132 may include a connector 133 at its proximal end. The connector 133 may be a threaded member having a shape and size to mate with the flange 130. In some embodiments, the connector 133 includes deformable ribs that engage the flange 130 to connect the needle 132 thereto. The needle 132 may be a 25 gauge needle. In some embodiments, the needle 132 may be a 15 gauge needle, a 16 gauge needle, a 17 gauge needle, an 18 gauge needle, a 19 gauge needle, a 20 gauge needle, a 21 gauge needle, a 22 gauge needle, a 23 gauge needle, a 24 gauge needle, a 25 gauge needle, a 26 gauge needle, a 27 gauge needle, a 2 8 gauge needle, a 2 9 gauge needle, a 30 gauge needle, a 31 gauge needle, a 32 gauge needle, a 33 gauge needle, a 34 gauge needle, or a 35 gauge needle.

[0056] In one embodiment, the flange 130 may be capable of being connected to a set of tubes (not shown) in fluid communication with the drug in the container portion 126. The needle 132 may be connected to the flange 130 by a user, as described in more detail below. In one embodiment, the permanent needle 27 may be pre-attached and extend from the distal portion of the drug container 102.

[0057] The injector 10 may be configured to deliver all or part of the drug in the drug container 102. The drug contained in the drug container 102 may have a volume of approximately 10 ml. In one embodiment, the drug contained in the drug container 102 corresponds to a volume selected from:

a) 3 ml - 5 ml, 3 ml - 10 ml, 3 ml - 15 ml, 3 ml - 20 ml, 3 ml - 25 ml, 3 ml - 30 ml, 3 ml - 35 ml, 3 ml - 4 0 ml, 3 ml - 4 5 ml, 3 ml - 50 ml, 5 ml - 10 ml, 5 ml - 15 ml, 5 ml - 20 ml, 5 ml - 25 ml, 5 ml - 30 ml, 5 ml - 35 ml, 5 ml - 4 0 ml; 5 ml - 4 5 ml, 5 ml - 50 ml, 10 ml - 15 ml; 10 ml - 20 ml; 10 ml - 25 ml; 10 ml - 30 ml; 10 ml - 35 ml; 10 ml - 4 0 ml, 10 ml - 50 ml;

b) from about 3 ml to about 5 ml, from about 3 ml to about 10 ml, from about 3 ml to about 15 ml, from about 3 ml to about 20 ml, from about 3 ml to about 25 ml, from about 3 ml to about 30 ml, from about 3 ml to about 35 ml, from about 3 ml to about 40 ml, from about 3 ml to about 45 ml, from about 3 ml to about 50 ml, from about 5 ml to about 10 ml, from about 5 ml to about 15 ml, from about 5 ml to about 20 ml, from about 5 ml to about 25 ml, from about 5 ml to about 30 ml, from about 5 ml to about 35 ml, from about 5 ml to about 40 ml; from about 5 ml to about 45 ml, from about 5 ml to about 50 ml, from about 10 ml to about 15 ml; from about 10 ml to about 20 ml; from about 10 ml to about 25 ml; from about 10 ml to about 30 ml; from about 10 ml to about 35 ml; from about 10 ml to about 40 ml, from about 10 ml to about 50 ml;

c) at least about 3 ml, at least about 3.5 ml, at least about 4 ml, at least about 4.5 ml, at least about 5.5 ml, at least about 6 ml, at least about 6.5 ml, at least about 7 ml, at least about 7.5 ml, at least about 8 ml, at least about 8.5 ml, at least about 9 ml, at least about 9.5 ml, at least about 10 ml, at least about 10.5 ml, at least about 11 ml, at least about 11.5 ml, at least about 12 ml, at least about 12.5 ml, at least about 13 ml, at least about 13.5 ml, at least about 14 ml, at least about 14.5 ml, at least about 15 ml, at least about 15.5 ml, at least about 16 ml, at least about 16.5 ml, at least about 17 ml, at least about 17.5 ml, at least about 18 ml, at least about 18.5 ml, at least about 19 ml, at least about 19.5 ml, at least about 20 ml, at least about 25 ml, at least about 30 ml, at least about 35 ml, at least about 40 ml, at least about 45 ml, at least about 50 ml; and

d) at least 3 ml, at least 3.5 ml, at least 4 ml, at least 4.5 ml, at least 5.5 ml, at least 6 ml, at least 6.5 ml, at least 7 ml, at least 7.5 ml, at least 8 ml, at least 8.5 ml, at least 9 ml, at least 9.5 ml, at least 10 ml, at least 10.5 ml, at least 11 ml, at least 11.5 ml, at least 12 ml, at least 12.5 ml, at least 13 ml, at least 13.5 ml, at least 14 ml, at least 14.5 ml, at least 15 ml, at least 15.5 ml, at least 16 ml, at least 16.5 ml, at least 17 ml, at least 17.5 ml, at least 18 ml, at least 18.5 ml, at least 19 ml, at least 19.5 ml, at least 20 ml, at least 25 ml, at least 30 ml, at least 35 ml, at least 40 ml, at least 45 ml, at least 50 ml.

[0058] The flow rate of the injector 10 is highly dependent on the viscosity and volume of the drug. However, the injector 10 can deliver the full volume of drug at a rate of approximately 0.33 ml/s. The injector 10 can deliver 10 ml of drug at a rate of 0.33 ml/s. In one embodiment, the injector 10 delivers the full deliverable volume of drug at a rate of:

a) 0.5 ml/10 s, 0.75 ml/10 s, 1 ml/10 s, 1.25 ml/10 s, 1.5 ml/10 s, 1.75 ml/10 s, 2 ml/10 s, 2.25 ml/10 s, 2.5 ml/10 s, 2.75 ml/10 s, 3 ml/10 s, 3.25 ml/10 s, 3.5 ml/10 s, 3.75 ml/10 s, 4 ml/10 s, 4.2 5 ml/10 s, 4.5 ml/10 s, 4.7 5 ml/10 s, 5 ml/10 s;

b) 2 ml/30 s, 2.5 ml/30 s, 3 ml/30 s, 3.5 ml/30 s, 4 ml/30 s, 4.5 ml/30 s, 5 ml/30 s, 5.5 ml/30 s, 6 ml/30 s, 6.5 ml/30 s, 7 ml/30 s, 7.5 ml/30 s, 8 ml/30 s, 8.5 ml/30 s, 9 ml/30 s, 9.5 ml/30 s, 10 ml/30 s, 10.5 ml/30 s; And

c) 4 ml/min, 5 ml/min, 6 ml/min, 7 ml/min, 8 ml/min, 9 ml/min, 10 ml/min, 11 ml/min, 12 ml/min, 13 ml/min, 14 ml/min, 15 ml/min, 16 ml/min, 17 ml/min, 18 ml/min, 19 ml/min, 20 ml/min, 21 ml/min.

[0059] The viscosity of the drug may be 1-20 cP. In one embodiment, the drug may have a viscosity of:

a) 1 SP, 2 SP, 3 SP, 4 SP, 5 SP, 6 SP, 7 SP, 8 SP, 9 SP, 10 SP, 11 SP, 12 SP, 13 SP, 14 SP, 20 15 SP, 16 SP, 17 SP, 18 SP, 19 SP, 20 SP; And

b) between 1-20 cP, between 2-19 cP, between 3-18 cP, between 4-17 cP, between 5-16 cP, between 6-15 cP, between 7-14 cP, between 8-13 cP, between 9-12 cP, between 10-11 cP.

[0060] In some embodiments, the user's experience is improved if the injector 10 delivers the full volume of the drug as quickly as possible. Faster delivery may result in less pain and discomfort for the patient. The injector 10 may deliver the full deliverable volume of the drug in less than 5 seconds. In some embodiments, the injector 10 may deliver the full deliverable volume of the drug in less than 10 seconds, less than 15 seconds, less than 20 seconds, less than 25 seconds, less than 30 seconds, less than 35 seconds, less than 40 seconds, less than 45 seconds, less than 50 seconds, less than 55 seconds, less than 60 seconds, less than 70 seconds, less than 80 seconds, less than 90 seconds, less than 100 seconds, less than 110 seconds, or less than 120 seconds. In some embodiments, the injector 10 may deliver the full volume of medication in between 5-120 seconds, between 10-110 seconds, between 15-100 seconds, between 20-90 seconds, between 25-80 seconds, between 30-70 seconds, between 35-60 seconds, between 40-55 seconds, or between 45-50 seconds.

[0061] As shown in Fig. 1-10, the button 104 may be connected to the housing 100. The button 104 may be capable of rotation about the longitudinal axis L between the locked position and the unlocked position and may be movable along the longitudinal axis L between the pre-start position and the start position. The proximal end of the button 104 may be closed, and the distal end of the button 104 may be open. As shown in Fig. 11-12, the button 104 may include a button housing 136. The button housing 136 may have a generally cylindrical shape.

[0062] The button 104 may include a lock indicator 142 thereon to indicate a lock status of the button and/or to indicate that the button 104 is in a locked position. The lock indicator 142 may be engraved, etched, printed, or molded into the button 104. In one embodiment, the lock indicator 142 is a decal fixed to the button 104 using an adhesive. In one embodiment, the lock indicator 142 is applied to the button 104 by spray painting, powder coating, silk screening, laser marking, pad printing, or heat marking. The lock indicator 142 may be a graphic image of a lock indicating that the button 104 is in a locked position. The lock indicator 142 may be any combination of shapes and/or words.

[0063] The button 104 may include an unlocking indicator 14 4 thereon to indicate the locking status of the button and/or to indicate that the button 104 is in an unlocked position. The unlocking indicator 14 4 may be engraved, etched, printed or molded into the button 104. In one embodiment, the unlocking indicator 144 is a decal fixed to the button 104 using an adhesive. In one embodiment, the unlocking indicator 144 is applied to the button 104 by spray painting, powder coating, silk screening, laser marking, pad printing or heat marking. The unlocking indicator 144 may be a graphic image of a lock indicating that the button 104 is in an unlocked position. The unlocking indicator 144 may be any combination of shapes and/or words.

[0064] The button 104 may further include a rotation indicator 146 for indicating the direction in which the button 104 is movable about the longitudinal axis L. The rotation indicator 146 may be engraved on the button 104. In one embodiment, the rotation indicator 146 is a decal fixed to the button 104 using an adhesive. In one embodiment, the rotation indicator 14 6 is applied to the button 104 by spray painting, powder coating, silk screen printing, laser marking, pad printing or heat marking. The rotation indicator 146 may be an arrow indicating the direction in which the button 104 must be rotated relative to the housing 100 to move from the locked position to the unlocked position. The rotation indicator 146 may be any combination of shapes and/or words.

[0065] The button 104 may further include a translation indicator 148 for indicating the direction in which the button 104 is movable about the longitudinal axis L. The translation indicator 148 may be engraved on the button 104. In one embodiment, the translation indicator 148 is a decal fixed to the button 104 using an adhesive. In one embodiment, the translation indicator 14 8 is applied to the button 104 by spray painting, powder coating, silk screening, laser marking, pad printing or heat marking. The translation indicator 14 8 may be an arrow indicating the direction in which the button 104 must be rotated relative to the housing 100 to be translated from the pre-start position to the start position. The translation indicator 14 8 may be any combination of shapes and/or words.

[0066] The button 104 may further include a lock indicator 150 to indicate that the injector 10 has been fired and the button 104 is locked in the firing position. The lock indicator 150 may be engraved on the button 104. In one embodiment, the lock indicator 150 is a decal fixed to the button 104 using an adhesive. In one embodiment, the lock indicator 150 is applied to the button 104 by spray painting, powder coating, silk screening, laser marking, pad printing or heat marking. The lock indicator 150 may have an oval shape and a size to fill at least a portion of the status window 116 of the housing 100. The lock indicator 150 may be any combination of shapes and/or words.

[0067] In one embodiment, the button 104 comprises a partial dosing indicator (not shown) of a drug, such as a primary fill volume, at the location of the locking indicator 142. The partial dosing indicator may be engraved, etched, printed or molded into the button 104. In one embodiment, the partial dosing indicator is a decal fixed to the button 104 using an adhesive. In one embodiment, the partial dosing indicator is applied to the button 24 by spray painting, powder coating, silk screen printing, laser marking, pad printing or heat marking.

[0068] The proximal end of the button body 136 may include one or more ribs 138 that extend laterally inward or outward. One or more ribs 138 may increase friction when the user grips the button 104 to rotate the button 104 about the longitudinal axis L. The button 104 may be configured to rotate 45 about the longitudinal axis L. In some embodiments, the button 104 is configured to rotate 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 100°, 110°, 120°, 130°, 140°, 150, 160°, 170° or 180° about the longitudinal axis L. In some embodiments, the button 104 is configured to rotate between 20°-180°, between 25°-170°, between 30°-160°, between 35°-150°, between 40°-140°, between 45°-130°, between 50°-120°, between 55°-110°, between 60°-100°, between 65°-90°, between 70°-85° or between 75°-80° around the longitudinal axis L.

[0069] As shown in Fig. 11-12, the button 104 may include a button opening 14 0 that extends through the button housing 136. The button opening 140 may be located near the distal end of the button housing 136. The button opening 140 may have a shape and size to receive the stop component 106, as described in more detail below. The button 104 may include two button openings 140, separated by spaces, on the button housing 136. In some embodiments, there is one button opening 140.

[0070] As shown in Fig. 12, the button 104 may include a plate 152 that extends distally from the proximal end of the button 104. The plate 152 may extend from the inner surface of the button 104. The plate 152 may have a generally curved shape similar to the shape of the button body 136. The space between the button body 136 and the plate 152 may be the same along the width of the plate 152. The plate may include a projection 154 that extends radially inward along its inner portion. The projection 154 may extend along the length of the plate 152. In one embodiment, the projection 154 may extend from only a portion of the plate 152. The projection may have a generally rounded shape.

[0071] As shown in Fig. 11, the button 104 may include a button projection 156 extending radially outward from the button housing 136. The button projection 156 may be located between a proximal end and a distal end of the button housing 136. The button projection 156 may be shaped and sized to engage a shoulder 158 of the rear housing 114 to prevent proximal movement of the button 104 beyond a predetermined position, as shown in Fig. 7. The projection of the button 156 may have a generally flat proximal end that engages the step 158. The interaction of the projection of the button 156 and the step 158 may allow the button 104 to smoothly rotate relative to the housing 100. The projection of the button 156 may prevent the button 104 from rotating beyond a predetermined level when the projection of the button 156 engages the end of the step 158. The button 104 may further include a rim 157 that extends around the circumference of the button housing 136. The rim 157 may prevent the button 104 from deforming. In some embodiments, as shown in Fig. 11, there are a plurality of rims 157 that extend around the circumference of the button housing 136.

[0072] As shown in Fig. 6, the stopper 106 may be at least partially located inside the button 104. The button 104 may be pivotable and movable relative to the stopper 106. As shown in Fig. 13, the stopper 106 may comprise a stopper housing 160. The stopper housing 160 may have a generally cylindrical shape. The stopper may include a stop collar 162 extending radially outward from it. The stop collar 162 may be located at a distal end of the stopper housing 160. The stop collar 162 may include a collar engagement member 164 extending radially from it. The collar engagement member 164 may have a shape and size for receiving in a stopper receptacle 166 of the housing 100. As shown in Fig. 1, the engagement element of the coupling 164 can be located in the receiver of the stopper 166 when the injector 10 is assembled. The stopper 106 can be fixed relative to the housing 100.

[0073] As shown in Fig. 13, the stopper 106 may include a crown 168 formed on the proximal end of the stopper body 160. The crown 168 may have a configuration for engaging the button plate 152. The crown 168 may include one or more teeth 170 formed thereon. The tooth 170 may have a shape and size for receiving the projection 154 of the plate 152. The crown 168 may further include a surface 172 having a configuration for preventing distal movement of the button 104 relative to the stopper 106. As shown in Fig. 13, the crown 168 may include a locking tooth 170a adjacent to the surface 172 and an unlocking tooth 170b distant from the surface 172. When the projection 154 is received by the locking tooth 170a, the surface 172 may prevent the button 104 from moving along the longitudinal axis L, relative to the stopper 106. When the projection 154 is received by the unlocking tooth 170b, the button may be able to move along the longitudinal axis L, relative to the stopper 106.

[0074] As shown in Fig. 13, the stopper 106 may include an engagement element 174 that extends from the stopper body 160. The engagement element 174 may be movable between an engagement position and a disengaged position. The engagement element 174 may include a flexible leg 176 that extends along the longitudinal axis L and a projection 178 that extends radially from it. The projection 178 may have a generally triangular cross-section and may extend radially inward from the end of the flexible leg 176.

[0075] As shown in Fig. 14, the plunger 108 can be at least partially located in the stopper 106. The plunger 108 can be fixed, relative to the stopper 106, when the engaging member 174 is in the engaged position. The plunger 108 can be movable, relative to the stopper 106, when the engaging member 174 is in the disengaged position. As shown in Figs. 15-16, the plunger 108 can include a plunger body 180. The plunger body 180 can be generally cylindrical and can have a closed distal end. The plunger body 180 can have a configuration with a length for displacing a predetermined volume of the drug. For example, the length of the plunger body 180 can be increased to displace a larger volume of the drug or can be shortened to displace a smaller volume of the drug. The distal end of the piston 108 may have a configuration for interacting with the plunger 128 of the container for the drug 102. The distal end of the piston 108 may include a piston projection 182 extending from it. The piston projection 182 may enter the inside of the plunger 128. In some embodiments, the distal end of the piston 108 is smooth and does not include a piston projection 182.

[0076] Referring to Fig. 9-10, the piston 108 may include a piston opening 184 that extends through the piston body 180. The piston opening 184 may have a size and shape to receive at least a portion of the engagement member 174 when the button 104 is in the pre-start position. The piston opening 184 may have a generally rectangular shape. As shown in Fig. 13, the piston opening 184 may receive a projection 178 of the engagement member 174 when the engagement member is in the engaged position.

[0077] The energy source 110 may have a configuration for pushing the piston 108 distally along the longitudinal axis L, relative to the stop 106. As shown in Fig. 14, the energy source 110 may be located, at least partially, inside the piston 108. The proximal end of the energy source 110 may engage the proximal end of the stop 106 and may engage the distal end of the piston 108. In an illustrative embodiment, the energy source 110 includes a compression spring, however, another suitable energy source may be used, such as an electric pump, an elastomeric or gas compression spring, or a gas generator, or other suitable parts for storing energy.

[0078] The energy source 110 may be a compression spring. The energy source 110 may have a diameter of 5 mm. The energy source 110 may have a diameter of 6 mm. The energy source 110 may have a diameter of 7 mm. The energy source 110 may have a diameter of 8 mm. The energy source 110 may have a diameter of 9 mm. The energy source 110 may have a diameter of 10 mm. The energy source 110 may have a diameter of 11 mm. The energy source 110 may have a diameter of 12 mm. The energy source 110 may have a diameter of 13 mm. The energy source 110 may have a diameter of 14 mm. The energy source 110 may have a diameter of 15 mm. The energy source 110 may have a wire diameter of 0.75 mm. The energy source 110 may have a wire diameter of 1 mm. The energy source 110 may have a wire diameter of 1.25 mm. The energy source 110 may have a wire diameter of 1.5 mm. The 110 power source may have a wire diameter of 1.75 mm. The 110 power source may have a wire diameter of 2 mm.

[0079] The power source 110 can generate a force of at least 8 lbf (36 N), a force of at least 9 lbf (40 N), a force of at least 10 lbf (44 N), a force of at least 11 lbf (49 N), a force of at least 12 lbf (53 N), a force of at least 13 lbf (58 N), a force of at least 14 lbf (62 N), a force of at least 15 lbf (67 N), a force of at least 16 lbf (71 N), a force of at least 17 lbf (76 N), a force of at least 18 lbf (80 N), a force of at least 19 lbf (85 N), a force of at least 20 lbf (89 N), a force of at least 21 lbf (93 N), a force of at least 22 pounds-force (98 N), a force of at least 23 pounds-force (102 N), a force of at least 2 4 pounds-force (107 N), a force of at least 25 pounds-force (111 N), a force of at least 26 pounds-force (116 N), a force of at least 27 pounds-force (120 N), a force of at least 28 pounds-force (125 N), a force of at least 29 pounds-force (12 9 N), or a force of at least 30 pounds-force (133 N). The energy source 110 can generate a force between 8-30 lbf (36-133 N), a force between 9-2 9 lbf (40-12 9 N), a force between 10-28 lbf (44-125 N), a force between 11-27 lbf (49-120 N), a force between 12-26 lbf (53-116 N), a force between 13-25 lbf (58-111 N), a force between 14-24 lbf (62-107 N), a force between 15-23 lbf (67-102 N), a force between 16-22 lbf (71-98 N), a force between 17-21 lbf (76-93 N), or a force between 18-20 lbf (80-89 N).

[0080] The power source 110 can generate a force of up to 15 pounds-force (67 N) before the launch event. The power source 110 can generate a force of up to 17.5 pounds-force (78 N) before the launch event. The power source 110 can generate a force of up to 20 pounds-force (89 N) before the launch event. The power source 110 can generate a force of up to 22.5 pounds-force (100 N) before the launch event. The power source 110 can generate a force of up to 25 pounds-force (111 N) before the launch event. The power source 110 can generate a force of up to 27.5 pounds-force (122 N) before the launch event. The power source 110 can generate a force of up to 30 pounds-force (133 N) before the launch event.

[0081] The energy source 110 can generate a residual force of 8 pounds-force (36 N) after displacing the full volume of liquid from the primary container. The energy source 110 can generate a residual force of 10 pounds-force (44 N) after displacing the full volume of liquid from the primary container. The energy source 110 can generate a residual force of 12 pounds-force (53 N) after displacing the full volume of liquid from the primary container. The energy source 110 can generate a residual force of 14 pounds-force (62 N) after displacing the full volume of liquid from the primary container. The energy source 110 can generate a residual force of 16 pounds-force (71 N) after displacing the full volume of liquid from the primary container. The energy source 110 can generate a residual force of 18 pounds-force (80 N) after displacing the full volume of liquid from the primary container. The energy source 110 can generate a residual force of 20 pounds-force (89 N) after displacing the full volume of liquid from the primary container.

[0082] It is possible to prevent the movement of the piston 108, relative to the stopper 106, by means of the button 104, when the button 104 is in the locked position. As shown in Fig. 6, the hole of the button 140 and the engagement element 174 are not aligned along the longitudinal axis L, when the button 104 is in the locked position. Thus, the body of the button 136 prevents the engagement element 174 from bending radially outward in response to pushing the piston 108 distally by the energy source 110. Rotation of the button 104, relative to the longitudinal axis L, from the locked position to the unlocked position can align the hole of the button 140 and the engagement element 174. As discussed above, rotation of the button 104, relative to the longitudinal axis L, can move the projection 154 of the plate 152 from the locking tooth 170a to the unlocking tooth 170b. At least a portion of the plate 152 may engage the crown 168 when the button 104 is in the locked position and when the button 104 is in the unlocked position.

[0083] Referring to Fig. 9-10, the movement of the button 104 distally along the longitudinal axis L, relative to the housing, from the pre-fire position to the fire position may allow the movement of the piston 108, relative to the stop 106. The movement of the button 104 to the fire position may cause the opening of the button 140 to overlap the engagement member 174. The energy source 110 pushing the piston 108 distally may cause the engagement member 174 to flex radially outward. The distal movement of the button 104 to the fire position may allow the engagement member 174 to flex radially outward and pass, at least partially, through the opening of the button 140. The piston 108 is free to move distally, relative to the stop 106, when the engagement member 174 is received in the opening of the button 140.

[0084] The piston 108 may engage the plunger 128, thereby moving the plunger 128 relative to the container for the drug 102, when the button is moved to the firing position. The movement of the plunger 128 relative to the container for the drug 102 may push a volume of the drug out of the container for the drug 102 through the flange 130. The drug can be expelled through the needle 132, when the needle 132 is connected to the flange 130.

[0085] The button 104 may be prevented from moving proximally relative to the housing 100 after the button 104 has moved from the pre-fire position to the fire position. The injector 10 may be a disposable injector. The radial outward bending of the engagement member 174 may prevent the button 104 from moving proximally along the longitudinal axis L when the button 104 is in the fire position.

[0086] The present invention may relate to a method of delivering a drug to a subject using an injector 10. The injector 10 may include a housing 100 having a proximal end and a distal end extending along a longitudinal axis L, a drug container 102 containing a volume of drug, a button 104 associated with the housing 100, where the button 104 is capable of rotating about the longitudinal axis L between a locked position and an unlocked position, and movable along the longitudinal axis between a pre-fire position and a fire position, a stopper 106 at least partially located inside the button 104, a piston 108 movable relative to the stopper 106, and a power source 110 configured to push the piston 108 distally along the longitudinal axis L.

[0087] As shown in Fig. 23, the method may include detaching the luer cap 134 from the flange 130 of the container for the drug 102 using the luer cap remover 186. As discussed above, the luer cap 134 may be fully recessed within the housing 100. As shown in Fig. 21, the luer cap remover 186 may include a flange 187 that extends radially outward from the end of the luer cap remover 186. The flange 187 may be a generally circular piece with a diameter larger than the diameter of the luer cap remover 186. The flange 187 may prevent the luer cap remover 186 from being positioned entirely within the housing 100. The flange 187 may include one or more user recesses 188 formed at its outer end. The user recess 188 may provide a surface for the user to more easily grip and rotate the luer cap remover 186. The user recesses 188 may be cutouts on the outer end of the flange 187. In some embodiments, the user recesses extend from the outer end of the flange 187. The end of the luer cap remover 186 opposite the user recess 188 may include a luer cap receptacle 190. The luer cap receptacle 190 may have a shape and size to allow it to receive the luer cap 134. The luer cap receptacle 190 may include at least one rib 191 extending radially inward from the inside of the luer cap receptacle 190 to frictionally retain the luer cap 134, when the luer cap 134 is located therein. The luer cap receiver 190 may include a groove 193 formed along its length. The groove 193 may have a generally rectangular shape and may allow the ends of the luer cap receiver 190 to bend radially inward or outward when it is located in the housing 100 to accommodate the luer cap 134. The luer cap remover 186 may allow the user to rotate the luer cap 134 to remove the luer cap 134 from the flange 130.

[0088] As shown in Fig. 24, the method may include connecting the needle 132 to the flange 130. The needle 132 may be in fluid communication with the drug container 102 when the needle 132 is connected thereto. The needle 132 may include a needle sheath 192 connected thereto. The needle sheath 192 may provide protection for the tip and prevent unintentional insertions of the needle. The needle sheath 192 may include one or more ribs that allow a user to hold and rotate the needle 132 to connect the needle 132 to the flange 130. The needle sheath 192 may be removed from the needle, as shown in Fig. 24, to thereby expose the needle 132 for use.

[0089] The method may include rotating the button 104 to an unlocked position. As discussed above, rotating the button 104 to an unlocked position may align the button opening 140 of the button 104 with the engaging element 174 of the stopper 106. After moving to the unlocked position, the button 104 may be in a pre-fire position. The piston 108 may be prevented from moving relative to the stopper 106 by means of the button 104 in the pre-fire position.

[0090] The method may include inserting at least a portion of the needle 132 into the subject's body. The needle 132 may be inserted to an insertion depth. After inserting the needle 132 into the subject's body, the method may include moving the button 104 distally, relative to the housing 100, to a firing position. In some embodiments, rotating the button 104 to an unlocked position and moving the button 104 distally along a longitudinal axis L, relative to the housing 100, to a firing position may allow the piston 108 to move relative to the stop 106. Moving the button 104 distally to the firing position may allow the engagement member 174 to flex radially outward and pass, at least partially, through the opening of the button 140 by closing the opening of the button 140 and the engagement member 174.

[0091] The method may include pushing a volume of a drug through a needle 132 into the body of a subject. The piston 108 may engage a plunger 128 located in a drug container 102, thereby moving the plunger 128 relative to the drug container 102 when the button 104 is moved to the firing position. In some embodiments, the movement of the plunger 128 relative to the drug container 102 pushes a volume of the drug from the drug container 102 through the needle 132. The button 104 may be prevented from moving proximally relative to the housing 100 after the button 104 is moved to the firing position. The method may include removing the needle 132 from the body of the subject after the drug has been pushed through it. The user may dispose of the injector 10 after use.

[0092] The term "about" or "approximately" is used herein to provide a literal justification for the exact quantity it precedes, as well as for a quantity that is about or approximately the quantity the term precedes. In determining whether a quantity is about or approximately a specifically recited quantity, an unlisted quantity of about or approximately may be a quantity that, in the context in which it is presented, provides a substantial equivalent to the specifically recited quantity. It should be understood that all numerical values and ranges described herein are approximate values and ranges, regardless of whether "about" is used in connection therewith. It should also be understood that the term "about", as used herein in connection with a number, refers to a value that may be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive) of that number, ±2% (inclusive) of that number, ±3% (inclusive) of that number, ±5% (inclusive) of that number, ±10% (inclusive) of that number, or ±15% (inclusive) of that number. It should further be understood that when a numerical range is described in the present specification, any numerical value falling within the range is also specifically described.

[0093] It will be apparent to those skilled in the art that changes may be made to the illustrative embodiments shown and described above without departing from the broad inventive concepts thereof. It should be understood that the embodiments and claims described in this specification are not limited in their application to the construction details and arrangements of components set forth in the description and illustrated in the drawings. Instead, the description and drawings provide examples of contemplated embodiments. The embodiments and claims described in this specification are further capable of other embodiments and of being practiced and carried out in various ways.

[0094] Specific features of the illustrative embodiments may or may not form part of the claimed invention, and various features of the described embodiments may be combined. Unless otherwise specifically indicated in this specification, singular terms are not limited to a single element, but should instead be read to mean "at least one." Finally, unless otherwise specifically indicated in this specification, a described or claimed method should not be limited to performing its steps in a written order, and one skilled in the art will recognize that the steps may be performed in any practicable order.

Claims (57)

1. An injector containing: a body having a proximal end and a distal end that extend along the longitudinal axis; a container for a medicinal product containing a volume of a medicinal product; a button having a button housing, a button opening passing through the button housing, and a plate extending distally from a proximal end of the button housing, connected to the housing, where the button is configured to rotate about a longitudinal axis between a locked position and an unlocked position and move along the longitudinal axis between a pre-start position and a start position; a stopper having a stopper body, a crown formed at a proximal end of the stopper body, configured to engage a button plate, and an engagement element extending from the stopper body, where the engagement element is configured to move between an engagement position and a disengaged position, at least partially located inside the button; a piston movable relative to the stopper; and an energy source configured to push the piston distally along the longitudinal axis, wherein the movement of the piston relative to the stopper is prevented by means of a button in the pre-start position, wherein turning the button to the unlocked position aligns the button hole with the engagement element, and In this case, turning the button to the unlocked position and moving the button distally along the longitudinal axis, relative to the body, to the starting position allows the piston to move relative to the stopper. 2. The injector of claim 1, wherein at least a portion of the plate engages the crown when the button is in the locked position and in the unlocked position. 3. An injector according to claim 1, wherein the piston includes a piston body and a piston opening passing through the piston body, wherein the piston opening is configured to receive at least a portion of the engagement element when the button is in the pre-start position. 4. The injector according to item 1, wherein the engagement element comprises: a flexible stem extending along the longitudinal axis; and a projection extending radially from it. 5. The injector of claim 4, wherein the projection extends radially inward from the end of the flexible leg. 6. The injector of claim 1, wherein distal movement of the button to the firing position allows the engagement element to bend radially outward and pass at least partially through the opening of the button. 7. The injector of claim 1, wherein the container for the drug comprises a Luer lock extending from its distal end, wherein the injector further comprises: a plunger located inside a container for the medicine. 8. An injector according to claim 7, wherein the piston engages the plunger, thereby moving the plunger, relative to the container for the drug when the button is moved to the firing position. 9. An injector according to claim 8, wherein movement of the plunger relative to the drug container expels a volume of drug from the drug container through the Luer lock. 10. The injector according to item 7, additionally containing: a needle attached to a Luer lock, where the needle is in fluid communication with the container for the drug. 11. The injector according to item 7, additionally containing: Luer cap, with removable Luer connection in storage configuration, where the luer cap is fully recessed into the housing. 12. An injector according to claim 1, wherein proximal movement of the button relative to the housing is prevented after the button has moved from the pre-start position to the start position. 13. An injector according to claim 1, wherein the volume of the medicinal product is at least 10 ml. 14. The injector according to claim 1, wherein the stopper is fixed relative to the housing, and wherein the container for the drug is fixed relative to the housing. 15. An injector containing: a body having a proximal end and a distal end that extend along the longitudinal axis; a container for a medicinal product having a Luer lock extending from its distal end and containing a volume of a medicinal product; a button connected to the housing, wherein the button is designed with the possibility of rotation around a longitudinal axis between a locked position and an unlocked position and movement along the longitudinal axis between a pre-start position and a start position; a stopper located at least partially within the button; piston movable relative to the stopper; a plunger located inside the container for the drug; and an energy source configured to push the piston distally along the longitudinal axis, wherein the movement of the piston relative to the stopper is prevented by means of a button in the pre-start position, and In this case, turning the button to the unlocked position and moving the button distally along the longitudinal axis, relative to the body, to the starting position allows the piston to move relative to the stopper. 16. An injector according to claim 15, wherein the piston engages the plunger, thereby moving the plunger, relative to the container for the drug when the button is moved to the firing position. 17. An injector according to claim 16, wherein movement of the plunger relative to the drug container expels a volume of drug from the drug container through the Luer lock. 18. The injector according to item 15, additionally containing: a needle attached to a Luer lock, where the needle is in fluid communication with the container for the drug. 19. The injector according to item 15, additionally containing: Luer cap, with removable Luer connection in storage configuration, where the luer cap is fully recessed into the housing. 20. An injector containing: a body having a proximal end and a distal end that extend along the longitudinal axis; a container for a medicinal product containing a volume of a medicinal product, wherein the container for the medicinal product is fixed relative to the housing; a button connected to the housing, wherein the button is designed with the possibility of rotation around a longitudinal axis between a locked position and an unlocked position and movement along the longitudinal axis between a pre-start position and a start position; a stopper at least partially located inside the button, where the stopper is fixed relative to the housing; a piston movable relative to the stopper; and an energy source configured to push the piston distally along the longitudinal axis, wherein the movement of the piston relative to the stopper is prevented by means of a button in the pre-start position, and In this case, turning the button to the unlocked position and moving the button distally along the longitudinal axis, relative to the body, to the starting position allows the piston to move relative to the stopper.