Device and method of use for injecting a medicament

Abstract

A device for injecting a medication is provided. The device has a housing with a container capable of holding the medication therein. At its proximal end, the container has a needle and a stopper. The device includes a plunger capable of engaging the stopper at one end. At the opposite end, the plunger engages a first elastic member and can move the stopper within the container to inject the medication from the container. The device includes a collar with a distal end and a proximal end, the distal end engaging with a carriage to cause rotation, and the proximal end engaging a second elastic member. The second elastic member can engage a skin sensor having a distal end and a proximal end. At the proximal end, the skin sensor can include an injection site. The housing has a cap capable of reducing or preventing movement of the skin sensor. [Selected Figure] Figure 2

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 62 / 642,281, filed Mar. 13, 2018, entitled "Delivery Device and Method", the entire contents of which are incorporated herein by reference.

Background Art

[0002] An autoinjector is a drug delivery device that facilitates the injection of a predetermined dosage of a drug. Autoinjectors are particularly useful for self - administration by patients or by those who are not trained.

[0003] Typically, an autoinjector allows for more delicate control over the injection process since the user can choose the injection site and inject the drug. By controlling the injection process more delicately, syringe - related trepidation, pain, and anxiety can be reduced, and patient compliance with taking a particular drug can be enhanced.

[0004] In many cases, autoinjectors can be effective in treating acute or chronic conditions. For example, in a chronic condition such as diabetes, an autoinjector can hold a specific dosage of insulin. The additional control provided by an autoinjector, along with a specific dosage of insulin, can increase patient compliance and prevent the administration of an inaccurate amount of drug to the patient.

[0005] In acute conditions such as the acute treatment of migraines, some patients are instructed to administer an emergency injection of a selective serotonin receptor agonist, such as sumatriptan. An autoinjector allows the patient to accurately control the dosage of the drug themselves, even when the patient is facing the pain and visual disturbances associated with a debilitating migraine.

[0006] Typically, an auto-injector device has one or more specific dosages of a drug pre-filled in a container such as a syringe. The syringe has a needle for the patient to pierce the skin and a plunger for delivering the drug from the syringe and the needle to the injection site.

[0007] After the injection is performed and the drug is discharged from the syringe, a needle guard or skin sensor can be deployed after the injection to cover the needle in order to reduce or prevent further puncture injuries from the needle or due to re-use of the needle.

[0008] Sometimes, an auto-injector with a needle guard or skin sensor can be unreliable, and the needle guard or skin sensor may deploy inappropriately or jam, preventing drug administration. This can be a particularly serious problem in life-threatening situations where the drug is urgently needed.

[0009] Therefore, it is desirable to provide a new device for administering a drug and a method for providing reliable and safe injections to the user. A device and method for injecting a drug that enables accurate administration of the drug to the injection site and can be used by untrained persons would be most beneficial. SUMMARY OF THE INVENTION

[0010] A new device and method for injecting a drug are provided that provide reliable and safe injections to the user. The device and method for injecting a drug provided enable accurate administration of the drug to the injection site and can be used by untrained persons.

[0011] The described delivery device and method include a housing having a proximal end and a distal end. The housing has a container disposed therein and configured to hold a medicament. In some embodiments, the container can be a syringe, having a needle at the proximal end and a stopper disposed within the container. At the distal end, the container is coupled to a plunger that can have a distal end and a proximal end. In some embodiments, at the proximal end, the plunger is configured to engage the stopper, and the distal end of the plunger engages an energy storage member and is configured to move the stopper within the container to expel the medicament from the container and discharge it from the needle. The energy storage member can be a first and / or a second elastic member. In some embodiments, the first elastic member can be a spring. The device has a carriage having at least a portion of the container disposed therein and rotatable relative to the housing. The device further includes a collar having a distal end and a proximal end, the distal end of the collar being configured to engage the carriage and rotate the carriage, and the proximal end of the collar being configured to engage, in some embodiments, a second elastic member that can be a spring. The device includes a skin sensor having a distal end and a proximal end, the distal end of the skin sensor being configured to engage the second elastic member, and the proximal end of the skin sensor being configured to contact the injection site. A cap configured to engage the proximal end of the housing can reduce or prevent movement of the skin sensor when the device is in an initial storage state.

[0012] In some embodiments, when the cap is removed from the housing of the device and an injection force is applied to the skin sensor, the second elastic member is compressed and engages the collar, and the collar rotates the carriage. As the carriage rotates, the first elastic member engages the plunger to expel the medicament from the container and discharge it from the needle.

[0013] In various embodiments, the devices of this disclosure are disposable and contain a single dose of a medicament. In some embodiments, the skin sensor retracts when the needle is inserted and is configured to extend to surround the needle after the medicament has been injected, protecting the user from accidental puncture injury. In other embodiments, a first elastic member, which can be a spring, is in a compressed state before an injection force is applied to the skin sensor. In yet other embodiments, the distal end of the plunger includes a restraint member that is configured to reduce or prevent movement of the plunger and to hold the first elastic member in a compressed state.

[0014] Rotation of the carriage causes rotation of the high-speed member of the plunger to decompress the first elastic member, enabling the plunger to move the stopper within the container or enabling the syringe to discharge the medicament from the container and release it from the needle.

[0015] In various embodiments, the needle of the container is protected at its proximal end by a needle shield. The needle shield can be made of a material that is flexible relative to the housing and / or can be a rigid member relative to the first or second elastic member.

[0016] In many embodiments, the device can further include a cap insert coupled to the cap. The cap insert can have a capture member for the needle shield, and the capture member is configured to remove the needle shield of the needle when the cap is removed from the housing.

[0017] In some embodiments, the device further comprises a skin sensor insert coupled to the skin sensor, the skin sensor insert being configured to couple to the cap insert. In other embodiments, the skin sensor insert is not configured to couple to the cap insert. In other embodiments, the skin sensor insert comprises a locking surface configured to lock with a locking surface of the cap before the cap is removed. In various embodiments, the locking drive surface of the skin sensor insert is a W-shaped cam, and the locking surface of the cap is a triangular cam that couples to the W-shaped cam of the skin sensor insert. In other embodiments, the locking surface is a U-shaped slot 237 and a skin sensor insert surface as described below.

[0018] This disclosure also provides a method of injecting a dosage of a medicament, the method comprising the step of injecting a dosage of the medicament into an injection site using an injection device, the injection device comprising a housing having a distal end, the housing having a container disposed therein, the container being configured to hold the medicament, the container having a needle at its proximal end and having a stopper disposed within the container, a housing, a plunger having a distal end and a proximal end, the proximal end of the plunger being configured to engage the stopper, the distal end of the plunger being configured to engage a first elastic member, the plunger moving the stopper within the container to discharge the medicament from the container and release it from the needle, a carriage having at least a portion of the container disposed therein and being rotatable relative to the housing, a collar having a distal end and a proximal end, the distal end of the collar being configured to engage the carriage to cause rotation of the carriage, the proximal end of the collar being configured to engage a second elastic member, a skin sensor having a distal end and a proximal end, the distal end of the skin sensor being configured to engage the second elastic member, the proximal end of the skin sensor being configured to contact a skin site, and a cap configured to engage the proximal end of the housing to prevent movement of the skin sensor. In various embodiments, removal of the cap, which is removed from the housing before injecting a dosage of the medicament into the injection site, exposes the skin sensor that can be applied to the injection site with an injection force and the needle can be inserted into the patient's skin to inject the medicament from the container through the needle. The needle is then withdrawn from the injection site. In various embodiments, application of the skin sensor to the injection site and withdrawal of the needle from the injection site are performed manually.

[0019] This disclosure also provides a removable cap for a device that injects a medicament. In some embodiments, the cap can be a cap for an autoinjector and can comprise a tubular body having a substantially elliptical cross-sectional profile, the tubular body having a proximal end and a distal end, the proximal end being configured to receive a cap insert for covering the tubular body of the cap, and the distal end being configured to receive the housing of the device. In various aspects, the cap further comprises a grip mechanism at the distal end of the tubular body, and in other aspects, the cap comprises lock lugs or cams for providing a locking mechanism for the device. In some aspects, the cap comprises a recess for retaining the housing of the device. In some aspects, the cap insert of the device comprises a cover for a needle shield of a needle attached to a container, a cap insert body, and a capture member, the container being disposed within the housing of the device. In many aspects, the capture member is a tubular shaft centrally disposed along the longitudinal axis on the cover of the cap, the tubular shaft further comprising a clip hook for engaging the needle shield of the needle. Also, the cap insert comprises two arms disposed around the capture member of the cap insert configured to engage the proximal end of the cap and having opposing inner concave surfaces.

[0020] In various embodiments, the cap is configured to engage the proximal end of the housing and the skin sensor, and the cap has a locking surface configured to lock using the locking surface of the skin sensor to prevent movement of the skin sensor. In some aspects, the locking surface of the cap includes a recess or a protrusion, and the skin sensor further includes a skin sensor insert, and the skin sensor insert includes a recess or a protrusion that locks with the recess or the protrusion of the locking surface of the cap. In other aspects, the recess or the protrusion of the cap is a triangular cam, and the recess or the protrusion of the skin sensor insert is a W-shaped cam configured to couple with the triangular cam of the cap. In many aspects, the skin sensor insert includes lugs configured to engage U-shaped slots within the carriage and / or slots within the skin sensor.

[0021] In various aspects, the carriage of the device described in this disclosure includes a tubular body having a proximal end, a distal end, a lower portion at the proximal end, and an upper portion at the distal end, the upper portion having a base, the base having a lower rim, an upper rim, and two arms extending from the upper rim, the arms forming a U-shape facing each other, and the upper rim and the carriage being configured to receive a drug container. In many aspects, the carriage can be monolithic. In many aspects, at the proximal end, the carriage includes an abort rail, an injection rail, and a lock or inverted J rail, all the rails being spaced apart and adjacent to each other, and the abort rail being disposed between the lock rail and the injection rail. In various embodiments, the lock rail includes a U-shaped slot configured to engage a lug of the skin sensor insert to prevent movement of the skin sensor when the device is dropped or subjected to an impact. In many aspects, when the cap is removed from the housing, a second elastic member drives the needle guard insert along the slope of the U-shaped slot to disengage from the lock rail.

[0022] In many embodiments, the skin sensor insert further includes external pins, and the skin sensor includes an external slot and a cam surface configured such that the external pins of the skin sensor insert travel along the cam surface of the skin sensor and engage with the slot of the skin sensor on the assembly. In some aspects, the distal end of the skin sensor further includes a cam for engaging a collar. In other aspects, the collar further includes a threshold face at its distal end, and the cam of the skin sensor rotates the threshold face of the collar to engage the carriage and generate a threshold force that can vary from about 9 N to about 23 N.

[0023] This disclosure also provides a method of injecting a medicament, the method comprising injecting a dosage of the medicament into an injection site using an injection device, the injection device comprising a housing having a proximal end, the housing having a container disposed therein, the container being configured to hold the medicament, the container having a needle at its proximal end and a stopper disposed within the container, a plunger having a distal end and a proximal end, the proximal end of the plunger being configured to engage the stopper, the distal end of the plunger engaging a first elastic member to move the stopper within the container to dispense the medicament from the container and discharge it from the needle, a carriage disposed within the container and having at least a portion of the container, the carriage being rotatable relative to the housing, a collar having a distal end and a proximal end, the distal end of the collar engaging the carriage to cause rotation of the carriage, the proximal end of the collar being configured to engage a second elastic member, a skin sensor having a distal end and a proximal end, the distal end of the skin sensor being configured to engage the second elastic member, the proximal end of the skin sensor being configured to contact the skin, a proximal end of the housing, and a cap configured to engage the skin sensor, the cap being configured to lock with a lock surface of the skin sensor to prevent movement of the skin sensor.

[0024] In various embodiments, the carriage of the device described in this disclosure has at least a portion that engages a constrainer, the constrainer being at least partially disposed within the carriage and holding a container therein, the constrainer having an audible and / or tactile feedback member that indicates the administration of a drug, and the carriage being rotatable relative to a housing.

[0025] In many aspects, the constrainer comprises a cylindrical body and a wing member. The cylindrical body of the constrainer has a proximal end and a distal end and is configured to contact the constrainer at the proximal end and a plunger at the distal end. The wing member of the constrainer body extends along the longitudinal axis of the cylindrical body of the constrainer and comprises a feedback arm, the wing member, and a bridge member connecting the body to the wing member. In various embodiments, the constrainer is monolithic. In many embodiments, the constrainer further comprises a retaining clip between the proximal end and the distal end of the cylindrical body, the retaining clip being configured to suspend the container or, in some aspects, a syringe within the carriage. In some embodiments, the cylindrical body of the constrainer has a notch around the retaining clip of the container, the notch being substantially rectangular and forming a U-shape around the retaining clip of the constrainer. In other aspects, the retaining clip is a rectangular component at the outer edge around the body of the constrainer. In many aspects, the retaining clip comprises a body having a distal end adjacent to the distal end of the constrainer body and a proximal end adjacent to a notch within the constrainer body. The body of the retaining clip has a tapered and / or arcuate surface facing the inner surface of the constrainer body. In other aspects, the retaining clip further comprises a tab portion extending towards the inner surface of the constrainer body.

[0026] In various embodiments, the wing body of the wing member of the restraint is substantially rectangular. The wing body includes a first surface, a second surface facing the first surface, and side surfaces disposed between the first surface and the second surface. The first surface has a feedback arm and a bridge member connected to the wing body. The second surface can have a groove and a ridge. In many aspects, the first and second surfaces are substantially rectangular. In other embodiments, the bridge member on the first surface bisects the wing body that defines an upper wing above the cylindrical body of the restraint and a lower wing below the cylindrical body.

[0027] In many embodiments, the feedback arm of the wing member of the restraint includes an upper arm, a lower arm, and an elbow joint connecting the upper arm and the lower arm. In other embodiments, the upper arm has a first end adjacent to the first surface of the upper wing and a second end with a tip that protrudes beyond the elbow joint such that the lower arm forms an L-shape with the upper arm and the lower arm is longer than the tip of the upper arm. In many aspects, the feedback arm extends toward the restraint body such that a U-shape is formed between the upper arm, the lower arm, and the restraint body. In some aspects, the bridge member includes a rectangular arm and a triangular support, and the triangular support abuts against the first surface of the lower wing. In various embodiments, the restraint is configured such that when the plunger contacts the U-shaped opening of the feedback arm, the plunger actuates to push a drug into the interior of the container and generates an audible and / or tactilely perceptible sound that provides a signal to be released from the needle. In many aspects, the feedback arm is flexible with respect to the housing such that the upper portion of the plunger moves beyond the feedback. In other aspects, the upper arm of the feedback arm is configured to extend horizontally away from the restraint body, and the plunger is movable longitudinally within the container.

[0028] The present disclosure also provides a method of injecting a dosage of a medicament, the method comprising injecting a dosage of the medicament at an injection site using an injection device, the injection device comprising: a housing having a proximal end, the housing having a container disposed therein, the container holding the medicament, the container having a needle at the proximal end and a stopper disposed within the container; a plunger having a distal end and a proximal end, the proximal end of the plunger being configured to engage the stopper, the distal end of the plunger being configured to engage a first elastic member, the plunger moving the stopper within the container to dispense the medicament from the container and discharge it from the needle; a carriage having at least a portion that engages the container, the container being at least partially disposed within the carriage, the carriage holding the container, the restraint having an audible and / or tactile feedback member for indicating administration of the medicament; a collar having a distal end and a proximal end, the distal end of the collar being configured to engage the carriage to cause rotation of the carriage, the proximal end of the collar being configured to engage a second elastic member; a skin sensor having a distal end and a proximal end, the distal end of the skin sensor being configured to engage the second elastic member, the proximal end of the skin sensor being configured to contact the skin; and a cap that engages the proximal end of the housing to prevent movement of the skin sensor.

[0029] Other features and advantages of this disclosure will become apparent from the following detailed description. However, the detailed description and specific examples, while indicating some embodiments of this disclosure, are for illustration only and will be apparent to those skilled in the art from this detailed description that various changes and modifications are possible within the spirit and scope of this disclosure. In part, other aspects, features, benefits, and advantages of the embodiments will become apparent with respect to the following description, the appended claims, and the accompanying drawings. Further, the relationships between objects in the figures are not to scale and may in fact be the opposite with respect to size. The figures are for the purpose of understanding and clarifying the structure of each object shown and some functions may be exaggerated in order to show a particular function of the structure.

Brief Description of the Drawings

[0030]

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Mode for Carrying Out the Invention

[0031] This disclosure can be more easily understood by referring to the following detailed description of the disclosure presented in connection with the accompanying drawings, which together form a part of the disclosure. This disclosure is not limited to the specific devices, methods, conditions or parameters described and / or shown herein, and the terms used herein are for the purpose of describing specific embodiments by way of example only and are not intended to limit the claimed disclosure. The following description is presented to enable those skilled in the art to make and use the disclosure.

[0032] Although the numerical ranges and parameters indicating the broad scope of this application are approximations, the numerical values shown in the specific examples are reported as accurately as possible. However, each numerical value inherently includes certain errors that inevitably result from the standard deviation found in each test measurement. Further, all ranges disclosed herein are to be understood to include any and all sub-ranges subsumed therein. For example, the range of "1 to 10" includes any and all sub-ranges (and including) between the minimum value of 1 and the maximum value of 10, i.e., any and all sub-ranges having a minimum value of 1 or more and a maximum value of 10 or less, such as 5.5 to 10.

[0033] Definition As used herein, and as including the appended claims, the singular forms "a", "an", and "the" include the plural, and references to a particular numerical value include at least that particular value, unless the context clearly dictates otherwise. As used herein, ranges can be expressed from a particular value of "about" or "approximately" and / or to another particular value of "about" or "approximately". When such a range is expressed, another embodiment includes from a particular value and / or to another particular value. Spatially relative terms such as "under", "below", "lower", "over", "upper", etc. are used to describe the placement of one element relative to a second element for ease of explanation. These terms are intended to encompass different orientations of the device in addition to the orientation shown in the figures. Further, terms such as "first", "second", etc. are also used to describe various elements, regions, sections, etc. and are not intended to be limiting. Similar terms refer to similar elements throughout the description. As used herein, "having", "containing", "including", "comprising" are open-ended terms indicating the presence of a feature but not excluding additional elements or features. The term "agent" includes substances suitable for injection for treating a condition or disease. An agent can include an active pharmaceutical ingredient and an excipient. The term "proximal" end of a self-injector or device refers to the end closest to the patient's skin. The term "distal" end refers to the end farthest from the patient's skin.

[0034] The following headings do not limit the disclosure in any way. Embodiments under any one heading can be used in conjunction with embodiments under any other heading. Next, specific embodiments of the present application are referred to in detail, and examples thereof are shown in the accompanying figures. The application is described in relation to the illustrated embodiments, but it will be understood that they are not intended to limit the application to those embodiments.

[0035] Device for injecting a drug New drug delivery devices and methods are described that provide reliable and safe injections to users. The drug delivery devices and methods provided enable accurate delivery of a drug to an injection site and can be used by untrained individuals. The present application provides embodiments of a delivery device and related methods of use for injecting at least one dose of a drug. The drug can be, for example, a liquid such as a solution, suspension, emulsion, gel, colloid, or foam.

[0036] The delivery device can be filled with any drug to be injected. For example, the delivery device can be filled with one or more drug dosages. Suitable drugs include, for example, analgesics, anti-inflammatory substances, hormones, beta agonist agents, alpha agonist agents, beta antagonist agents, alpha antagonist agents, benzodiazepines (e.g., diazepam), glucose regulators (e.g., insulin, glucagon, dextrose), anesthetics (e.g., opioids), narcotic antagonists (e.g., naloxone), cholinergic agents, anticholinergic agents, muscarinic agents, muscarinic antagonists, steroids, chloride salts (e.g., potassium chloride, sodium chloride, calcium chloride), iodide salts, cholinesterase reactivators, cholinesterase agonists, antibacterial agents, antiarrhythmic agents, vasodilators, defect contractants, anticoagulants, cardiovascular drugs, anti-Parkinson's drugs, antipsychotic drugs, immunosuppressive drugs, antihistamines, selective serotonin receptor agonists, or combinations thereof. The drug can be in the form of a liquid such as a solution, suspension, emulsion, gel, colloid, or foam.

[0037] In some embodiments, the delivery device includes a new emergency release pen. In some embodiments, the emergency release pen is a single-use disposable auto-injector with a pre-filled syringe. In some embodiments, the emergency release pen allows a patient to self-inject a drug, such as glucagon to treat hypoglycemia or naloxone to treat an overdose of a narcotic. In some embodiments, the emergency release pen is configured to be in an initial state where a cap covers the skin sensor or needle guard of the emergency release pen. The cap is removed to expose the skin sensor. The user applies an injection force to the skin sensor, which in turn ultimately moves the drug out of the container or syringe into the plunger and out of the needle into the injection site to deliver the drug. After the drug is released and the needle is withdrawn from the injection site, the skin sensor returns to its extended position to protect or cover the needle and prevent further use and unwanted puncture of the skin.

[0038] The illustrated delivery device 10 can be a disposable self-injector 12 that is a device for injecting a drug. In various embodiments, the needle and depth of penetration of the device can be designed for different amounts of drug and many types of injections. For example, in some embodiments, the self-injector 12 can be a disposable device, and in some embodiments, it can deliver up to 0.3 ml, and in some aspects, deliver 0.4 ml of a low-viscosity formulation to an injection site having a needle injection depth of 12.7 mm to 16 mm. In other embodiments, the device can be designed to deliver more or less than the amounts shown above. In many embodiments, the device can be configured for intrathecal, epidural, intradermal, intramuscular, intravenous, intraperitoneal, intracardiac, intra-articular, and / or intracorporeal injection. As further described, the insertion and withdrawal of the needle is manually driven while the injection is spring-driven. The delivery device protects the needle when it is withdrawn. The delivery device has at least a dosage observation window so that the contents of the syringe or drug container can be seen before operation, and has additional pips or bumps on the housing to limit the risk of rolling off the inclined plane. Contrary to many conventional self-injectors, the delivery device of this disclosure is actuated by a skin sensor or needle guard rather than by an actuation button or actuator button to prevent unwanted needle punctures.

[0039] Referring to FIGS. 1 through 3, the self-injector 12 includes a removable cap 14 that covers the skin sensor 32 and functions as a needle shield remover. The self-injector 12 is also generally cylindrical along the longitudinal axis LL and includes a housing 18 that houses most of the other components of the self-injector 12 together with the upper part of the housing. In some embodiments, the housing 18 includes a collar 16 that fits into the skin sensor 32, a needle 28, and a syringe or container having a syringe stopper 31 that is slidably positioned on the syringe or container, all of which are at least partially included in a carriage 40 configured to engage a plunger 42. The self-injector 12 has a proximal end 19 and a distal end 23.

[0040] When the user removes the cap 14, that action automatically removes the needle shield 23 that covers the needle 28 of the syringe or container 30. In some embodiments, the needle shield 23 can be made of a rigid material that provides a rigid needle shield 24 to protect the needle 28. In other embodiments, the needle shield 23 can be made of a flexible material to provide a flexible needle shield 26. In still other embodiments, the needle 28 can be protected by a flexible needle shield 26 covered by a rigid needle shield 24. After the cap 14 is removed, the skin sensor 32 is not fully extended and is partially retracted. In some embodiments, the partially retracted skin sensor 32 is a fail-safe mechanism to prevent accidental injection.

[0041] To inject the drug, the user presses the skin sensor 32 against the skin at the site where injection is required, whereby the skin sensor can be fully retracted towards the distal end of the carriage 40, and the skin sensor engages with the skin sensor spring 36 and engages with the collar 16 without the collar rotating. The collar 16 engages with the carriage 40 and rotates the carriage when the needle 28 is inserted to a specific depth. When the carriage 40 rotates, it rotates the plunger 42 disposed at the distal end 21 of the carriage 40. The distal end of the carriage has a slot / hole that allows the plunger 42 to extend after the carriage 40 is fully rotatable to a position where the plunger 42 can pass through a channel present within the carriage.

[0042] In some embodiments, the autoinjector 12 includes a cap 14 configured to cover the skin sensor 32 when the autoinjector 12 is in a stored state. One embodiment of the cap 14 is shown in FIGS. 4A-4D. In this embodiment, the cap 14 generally has an elongated tubular body 14a with open ends, and generally has an elliptical cross-sectional shape. The major axis d1 on the ellipse is about 28 mm, and the minor axis d2 is 25 mm. At the proximal end, the cap 14 has a proximal opening 90 adapted to receive a cap insert 15 and a clip recess 102 that provides secure clip retention between the cap 14 and the cap insert 15. The cap 14 has a distal opening 91 on the opposite side of the proximal opening 90 adapted to connect to the housing 18 via a profiled interface 100, facilitating removal of the cap from the housing 18 by providing a natural lead out and providing tension to the label when the cap is twisted off. Externally, the cap 14 includes a grip mechanism 103 that facilitates holding of the cap. Internally, the cap 14 includes locking lugs or cams 104 for providing a locking means for actuating the autoinjector when the cap 14 is attached and the skin sensor insert 34 is in the locked position. The cap 14 also includes a retention hole 106 that interacts with a soft location bump on the housing 18. The length of the tubular body 14a is about 30 mm from the proximal end to the retention hole 106.

[0043] The cap insert 15 is coupled to the cap 14 and covers an opening 90 that extends through the proximal end of the cap 14. One embodiment of the cap insert 15 is shown in FIGS. 5A-5D. In this embodiment, the cap insert 15 includes a flat cover 110 and a cap insert body 114. The flat cover 110 has a substantially elliptical shape sized similar to the elliptical cross-sectional profile of the cap 14. The flat cover 110 includes a rigid and / or flexible needle shield capture member 124 disposed at the center of the circular flat cover 110 that projects in the distal direction. In some aspects, the rigid and / or flexible needle shield capture member 124 is formed as a tubular shaft 126 having a clip hook 128 configured to engage the end flange 27 of the rigid needle shield 24 and remove it when the cap 14 is removed. The capture member 124 has a length of about 10 mm and an outer diameter of about 8 mm. In various embodiments, the cap insert body 114 has opposing inner concave surfaces, is disposed around the needle shield capture member 124, extends longitudinally along axis CC, and has two arms 115 spaced apart from each other. Each arm 115 has an upper body 116 and a lower body 118 that abuts the upper body 116. The upper body of the arm 115 includes a base 117 from which a clip mechanism 120 extends distally along the longitudinal axis CC to provide a secure clip hold between the cap 14 and the cap insert 15. In other embodiments, each clip mechanism 122 extends from the base 117 and has two arms that form a U-shape therebetween. The lower body 118 of the arm 115 includes a clip opening 112 for providing a positive mechanism for clipping to the skin sensor 32.

[0044] In some embodiments, the syringe or container 30 is protected by a flexible needle shield 26 coupled to a rigid needle shield (RNS) 24, as shown, for example, in FIGS. 2 and 18a. The flexible needle shield 26 wraps around the needle 28 and is surrounded by the rigid needle shield 24, both configured to protect the needle 28 of the syringe or container 30. The rigid needle shield 24 has a tapered surface with a cylindrical shape at the tip of the needle 28 and has an end flange 27 for interacting with the clip hook 128 of the tubular shaft 126 of the cap insert 15. When the cap 14 is removed, the clip hook 128 catches on the end flange 27 of the rigid needle shield 24 and is removed from the syringe or container 30. In some aspects, the clip hook 128 of the cap insert 15 can simultaneously remove the flexible needle shield 26 and the rigid needle shield 24 when the cap assembly of the cap 14 and the cap insert 15 is removed. In some embodiments, the rigid needle shield 24 can have a length of about 25 mm to 35 mm and an outer diameter of about 5 mm at its distal end.

[0045] To initiate the operation of the autoinjector 12, the user removes the cap 14 by pulling and / or twisting. This action can result in three main actions. (i) The label fixed to both the autoinjector body and the cap 14 tears in two, (ii) the rigid needle shield 24 is pulled out of the autoinjector 12, and (iii) the skin sensor lock that secures the autoinjector during transportation is released. The device label is intended to be attached to both the device body and the cap, and when the cap is removed, the label tears along the perforation line of the profile, serving as evidence of unauthorized use and losing sterility. The cap assembly (cap 14 and cap insert 15) is clipped to the end flange 27 of the rigid needle shield (RNS) 24 during assembly, so when the cap 14 is removed, the RNS is simultaneously pulled out of the syringe. Thus, when the cap is removed, the needle shield is also removed.

[0046] Referring to FIGS. 6A-6D, in one embodiment, the housing 18 generally has an elongated tubular body with open ends and has a generally oval cross-sectional profile that is substantially the same size as the removable cap 14. The tubular body 133 of the housing 18 includes a lower portion 134, an upper portion 135, and two openings, a proximal opening 136 and a distal opening 138. In some embodiments, the tubular body 133 of the housing 18 is monolithic. At the proximal end, the lower portion 134 has a proximal opening 136 with a substantially round circumference and has a substantially cylindrical portion 137 configured to fit into the cap assembly. In some embodiments, at the proximal opening 136, the lower portion 134 has an outer diameter of about 20 mm. At the distal end, the lower portion 134 has a profiled interface 144 adjacent to the upper portion 135 to provide a natural lead to the cap 14. The cylindrical portion 137 includes two pips spaced apart from each other and configured to provide a natural fit with the retaining holes 106 of the cap 14. The tubular body 137 of the housing 18 also includes a gripping mechanism 142 that is continuous with the gripping mechanism 103 of the cap 14 to provide a smooth gripping portion of the self-injector 12 prior to use. The housing can be of various shapes including, but not limited to, cylindrical, circular, square. The housing has a profile and can be easily gripped during use. In some embodiments, the housing can be angled for right-handed and left-handed users or can be general for both hands.

[0047] To improve the visibility of the syringe and its contents, the tubular body of the housing 18 may have at least two windows 140 disposed on the spaced-apart cylindrical portions 137. The windows 140 are configured to enable visualization of materials such as, for example, the syringe or container 30 and / or the drug within the syringe or container 30. In one embodiment, the window 140 is configured to be a first color, such as red, when there is no syringe and / or drug within the housing 18, and a second color, such as green, when there is a syringe and / or drug within the housing 18. The housing 18 further includes a grip mechanism 142 that mates with the grip mechanism 103 of the cap 14. The housing 18 also includes a profiled cap interface 144 that mates with the cap 14 to provide a natural lead out and tension when the cap 14 is twisted. To provide secure retention of the skin sensor 32 and eliminate the possibility of the skin sensor being removed after use, the housing 18 has at least two (2) skin sensor slots 148. At the lower part of each window 140, the tubular body of the housing 18 includes an assembly hole 150 that enables secure retention of the skin sensor 32 when the cap assembly is mated during the automatic assembly of the auto-injector. In some embodiments, the total length of the tubular body 133 of the housing is about 90 mm.

[0048] Other elements of the auto-injector included in the housing 18 include a skin sensor insert 34, a skin sensor spring 36, a carriage 40, a collar 16, a retainer 38, a carriage thrust bearing 41, a plunger 42, a plunger spring 44, an upper housing 20, and an upper housing insert 22, all of which interact with each other as described herein.

[0049] The skin sensor 32 is disposed within the housing 18. The end of the skin sensor 32 is configured to engage tissue, such as the skin, when the self-injector 1 injects a substance, such as a drug, into or under the patient's skin. One embodiment of the skin sensor 32 is shown in FIGS. 7A-7D. Referring to FIGS. 7A and 7B, the skin sensor 32 includes a lower tubular portion 172 disposed proximally, an upper tubular portion 174 disposed distally, and a body 170 having a bore 161 extending throughout the body 170. At the proximal end, the bore 161 is adjacent to the front surface 171 of the tubular lower portion 172, and the front surface 171 has a central opening 173 configured such that the needle 28 can pass therethrough when the self-injector 12 is pressed against the injection site and the skin and the skin sensor retracts.

[0050] Compared to the upper tubular portion 174 disposed distally, the tubular lower portion 172 has a reduced diameter profile adapted to allow the skin sensor insert 34 to incorporate a locking mechanism. In some embodiments, the diameter of the lower portion 172 is about 15 mm. Externally, the lower tubular portion 172 also includes at least two spaced-apart cap assembly retention pips 164 that facilitate the clipping of the cap 14 sub-assembly to the skin sensor 32. The upper tubular portion 174 of the skin sensor body 170 includes a base 175 that abuts the lower portion 172 and two arms 176 having opposing internal concave surfaces that generally extend axially from the base 175 along the longitudinal axis DD and are adapted to receive the skin sensor spring 36.

[0051] The upper tubular portion 174 of the skin sensor 32 includes at least clip slots 160 configured to receive at least the outer lugs 186 of the skin sensor insert 34. In some embodiments, the upper tubular portion 174 has two clip slots 160 configured to receive the outer lugs 196 of the skin sensor insert 34. Each arm 176 includes an outer lug 162 having a double dovetail section that provides a secure position within the housing 18 to ensure functionality and eliminate the possibility of removal of the skin sensor 32 after use. In some aspects, the diameter of the upper tubular portion 174 of the skin sensor 32 is about 20 mm. In other aspects, the overall length of the skin sensor 32 is about 57 mm.

[0052] The upper tubular portion 174 of the skin sensor 32 also includes a skin sensor cam or ramp 166 that can interact with the outer tab 62 of the collar 16 to overcome the initial threshold force generated by the interaction of the end face 171 of the skin sensor 32 with the user's skin. The upper tubular portion 174 of the skin sensor 32 further includes an assembly relief feature 167 added to the skin sensor base 175 that provides position and clip shape when assembling the skin sensor insert 34. Further, the assembly relief feature 167 can provide assembly assistance and lock the skin sensor insert 34 to the carriage while the two components are fixed together.

[0053] The skin sensor insert 34 is disposed within the skin sensor 32. An embodiment of the skin sensor insert 34 is illustrated in FIGS. 8A-8D. Referring to FIGS. 8A-8D, the skin sensor insert 34 includes a tubular body 190 having a cylindrically-shaped distal upper body 192 that defines a bore 191 and abuts a proximally-located lower cylindrical skirt 194 having a surface 193 that extends generally radially outward from a base 188 and an upper body 192. In various embodiments, the diameter of the upper body 192 is about 14 mm. In some embodiments, the diameter of the base 188 is about 17 mm. The skirt 194 extends generally axially from the base 188 and includes a pair of actuating wings or W-shaped cams 198 that provide means for the cap assembly to interact with the skin sensor insert 34 to rotationally drive the pin 200 to a locked position. In some embodiments, externally, the upper body 192 includes a spring alignment boss 196 that reduces the risk of excluding potential spring end capture and provides compensation for an increase in the length of the skin sensor spring 36. An embodiment of the skin sensor spring is shown in FIG. 16a. Internally, the upper body 192 further includes a pin 200 necessary to enable the desired locking function of sliding the carriage ramp upward for a locking mechanism, as further described in this disclosure. The skirt 194 includes an external retaining pin 202 that holds the skin sensor insert 34 in the skin sensor and provides the rotational freedom necessary for the locking mechanism.

[0054] The housing 18 further includes a carriage 40 and a collar 16 configured to slide on top of the carriage 40. One embodiment of the carriage 40 is shown in FIGS. 9A-9B. The carriage 40 has a tubular body 210 along a longitudinal axis, the tubular shape having a lower portion 212 and an upper portion 214 that abuts the lower portion 212. In one aspect, the carriage 40 is monolithic and made of a transparent material. The lower portion 212 has a proximal opening 211. In some aspects, the outer diameter of the lower portion 212 is about 10 mm. Externally, the lower portion 212 comprises at least one ramp ridge 228, and in some embodiments, two ramp ridges 228 are spaced apart from each other, and in some aspects, are on opposite sides of the lower portion 212 and are disposed at the distal end of the lower portion 212. The ramp ridge 228 provides a carriage threshold surface 233 configured to partially rotate the carriage 40 and receive the collar 16 in cooperation with the skin sensor 32, and has a straight edge 229 and an arcuate edge 230 that meet at point 231. The skin sensor 32 provides a preload to the spring 36, the preload force acting axially on the collar 16, thereby creating a moment of rotation on the carriage 40 by the arcuate edge 230. In some embodiments, the arcuate edge 230 can be helical. In various aspects, the straight edge 229 can have a length of about 25 mm and the arcuate edge 230 can have a length of about 30 mm.

[0055] In various embodiments, the lower portion 212 includes an abort rib or rail 232, injection rails or ribs 234 spaced apart from each other, and an inverted J rib or lock rail 236, all disposed around the proximal opening 211 of the carriage body 210 and included for the function of needle insertion and aborting, and the injection function available to the autoinjector 12. The abort rib or rail 232 and the injection rib or rail 234 are spaced apart from each other, but the abort rib is disposed adjacent to the injection rib in a state where the abort rib is shorter than the injection rib. In various embodiments, the injection rail 234 abuts against the straight edge 229 of the inclined ridge 228. In some aspects, the abort rail 232 has a length of about 20 mm, and the injection rail has a length of about 36 mm. The abort rib 232 is located between the inverted J rib, or rail 236, and the injection rail 234. The inverted J rib 236 has a straight side 238 and a U-shaped channel 237. In various aspects, the straight side 238 of the inverted J rail 236 has a length of about 16 mm. In other aspects, all of the outer rails of the carriage 40 have a thickness of about 1.5 mm. In some embodiments, the abort rib 232, the injection rib 234, and the inverted J rib or lock rail 236 are spaced apart and include pairs facing each other.

[0056] In other embodiments, the upper portion 214 includes a base 216 having a lower rib 218 and an upper rim 220, both rims being configured to receive a carriage thrust bearing 41. In some embodiments, the upper portion 214 of the carriage 40 further extends from the upper rim 220 disposed around the distal opening 227 and includes two arms or ears 226 that face each other and form a U-shape with the upper rim 220. In various embodiments, the lower rim 218 has an outer diameter of about 10 mm, and the upper rim 20 has an outer diameter of about 17 mm. In other embodiments, the arms or ears 226 have a length of about 21 mm.

[0057] Color 16 is coupled to the skin sensor 32 at the proximal end and to the carriage 40 at the distal end. One embodiment of the Color 16 is illustrated in FIGS. 11A - 11D. In this embodiment, the Color 16 has a tubular body 50 with a bore 49 therethrough, and the body 50 is defined by a ribbed wall having a proximal opening 51 and a distal opening 53. Externally, the Color 16 includes ribs 54 and a ridge 55, both of which are useful for optimizing the ejector and provide sufficient wall thickness. In one embodiment, the rib 54 has a length of about 17 mm.

[0058] Distally, the tubular body 50 has a collar threshold surface 64 configured to couple with a carriage threshold surface 233 under the load of the skin sensor spring 36. In one embodiment, a carriage thrust bearing 41 is shown in FIGS. 10A and 10B. The carriage thrust bearing 41 has a proximal or lower surface 43a, a distal or upper surface 43b, and four tabs 48. The surface 43a of the four tabs 48 contacts the bottom of a slot in the housing 18 that defines where the carriage thrust bearing 41 is axially positioned in the housing 18. The distal surface 43b contacts the underside of the upper rim 220 of the carriage 40. In some embodiments, the outer diameter of the carriage thrust bearing 41 is about 20 mm. Proximally, the tubular body 50 of the collar 16 includes a spring alignment boss 52. In various embodiments, bosses 51 around the proximal opening 51 are spaced from each other and configured to preclude potential end capture of the skin sensor spring 36 that couples to the collar 16. The tubular body 50 of the collar 16 includes two windows 58 spaced apart and facing each other, each window being surrounded by a flag region 57 that provides an indicator to the patient when the autoinjector 12 is in use. In some aspects, the length of the window 58 is about 17 mm and, when the window 58 is square-shaped, the width is about 7 mm. In some embodiments, the collar 16 is manufactured in green to function as a patient indicator of the state of the autoinjector. The tubular body 50 also includes an assembly mechanism 56 located at the proximal end under each window opening 58. In some embodiments, distally at the end of the tube 50, the collar 16 includes an outer tab 62 movably disposed in a slot of the housing 18 to align the collar 16 rotationally with the housing 18.

[0059] The position of the syringe or container 30 is further controlled by a restraint 38. In some embodiments, the restraint 38 is configured to suspend the syringe or container 30 at the center of the carriage 40, thereby transmitting the needle injection load to the housing 18. One embodiment of the restraint 38 is illustrated in FIGS. 12A-12B. In this embodiment, the restraint 38 includes a cylindrical body 250, a wing member 270 adjacent to the body 250 and extending along the longitudinal axis BB, and a bridge member 330 connecting the cylindrical body 250 to the wing member 270. In some embodiments, the cylindrical body 250 is supported by two bridge members 330 between two wing members 270.

[0060] The cylindrical body 250 is defined by a peripheral wall 251, a distal opening 252, and a proximal opening 254 on the opposite side thereof. At the proximal end, the restraint body 250 has a flat surface 256 that contacts the syringe or container 30, and at the distal end, the cylindrical body 250 has a rim 255.

[0061] In various embodiments, on the peripheral wall 251, the restraint body 250 includes a syringe holding clip 258 attached to the rim 255. In some aspects, the outer diameter of the restraint body 250 is about 14 mm. Surrounding the holding clip 258 is a substantially rectangular notch 260, which, together with the holding clip, is configured to secure the syringe or container 30 suspended at the center of the carriage 40. In some aspects, the holding clip 258 is formed in a square shape with a tapered or arcuate tab extending toward the inner surface of the restraint body 250. In some aspects, the notch 260 forms a U-shape around the slightly recessed holding clip 258.

[0062] In various embodiments, the restraint 38 includes wing members 270, and in some embodiments, includes two wings 270 that are spaced apart from each other and connected to the restraint body 250 by a bridge member 330. In some embodiments, the wing member 270 has a rectangular body 272 with a first face 274, a second face 276, and a side face 278 between the first and second faces. In other embodiments, the length of the wing member 270 can be about 40 mm. The first face 274 can include a feedback arm 300 and a bridge member 330. In other embodiments, the second face 276 can include a groove 280 and a bridge 282. The side face 278 can also include a groove 288 and a ridge 289.

[0063] In various embodiments, the bridge member 330 bisects the body 272 of the wing member 270, defines an upper wing portion 284 on the restraint body 250, and defines a lower wing portion 286 below the restraint body 250. In some embodiments, the upper wing portion 284 is longer than the lower wing portion 286. In other embodiments, the upper wing portion 284 can have a length of about 22 mm and the lower wing portion 286 can have a length of about 17 mm. The groove 280a on the second face 276 of the upper wing portion 284 is larger than the groove 280b on the second face 276 of the lower wing portion 286. In some embodiments, the wing member 270 includes at least two grooves. In various embodiments, the bridge member 330 includes a rectangular arm 332 and a triangular support 334 disposed below and in contact with the rectangular arm 332. The triangular support 334 is lighter than the restraint body 250 and has a triangular surface that can press against more contact points on the wing member body 272.

[0064] In some embodiments, feedback arm 300 includes an upper arm 302, a lower arm 304, and an elbow joint 306 connecting the upper arm 302 and the lower arm 304. The upper arm 302 includes a first end adjacent to the first surface 274 of the upper wing portion 284 and a second end 309 having a tip 310 that slightly protrudes above the elbow joint 306 that forms an L-shape with the lower arm 304, and the lower arm is longer than the tip 310. In other embodiments, the upper arm 302 and the lower arm 304 extend toward the restraint body 250 and form a U-shape with the upper wing portion 284. In some embodiments, the restraint 38 is monolithic. In various embodiments, the upper arm 302 can have a length of about 6 mm and the lower arm 304 can have a length of about 2 mm.

[0065] In various embodiments, the restraint 38 is configured to generate an audible and / or tactile feedback to indicate that the plunger 42 actuates to push the drug within the syringe or container 30 when the plunger 42 contacts the elbow joint 306 of the feedback arm 300. In various embodiments, the container 30 does not move longitudinally relative to the housing 18.

[0066] Syringe 30 includes, for example, a stopper 30 that is movably positioned therein, as shown in FIG. 3. One embodiment of the syringe or container 30 is shown in FIGS. 17A and 17B. In the embodiment of FIG. 17B, the syringe or container 30 contains a drug. One embodiment of the stopper 31 is shown in FIGS. 17A and 17D. In various embodiments, the stopper 31 engages with the plunger 42 to move the stopper 31 within the syringe or container 30 to discharge the drug from the syringe or container 30. The syringe or container 30 further includes a needle 28. In various embodiments, depending on the location of the injection, the length of the needle 28 can be varied from about 7 / 8 of an inch to about 1 inch, have a gauge of about 25 to about 27G, from about 7 / 8 of an inch to about 1 1 / 4 inches, have a gauge of about 22 to 25G, and from about 1 inch to about 1 1 / 2 inches, and have a gauge of about 19 to about 25G.

[0067] The plunger 42 extends through the restrictor 38 into the syringe or container 30 to move a stopper within the syringe or container 30 to release a material, such as a drug, from the self-injector 12. One embodiment of the plunger 42 is shown in FIGS. 13A - 13D. In this embodiment, the plunger 42 includes an upper rod 400 at its distal end, a lower rod 500 at its proximal end, and a body 420 therebetween. The upper rod 400 connects to the lower rod 500 at its proximal end. The upper rod 400 forms a cross-sectional shape that is perpendicular to each other and in a cross shape. The lower rod 500 connects to the upper rod 400 at its distal end and to the stopper 31 at its proximal end. The lower rod 500 includes four rims 502 that are perpendicular to each other and form a cross-sectional shape. At the proximal end, the lower rod 500 has a flat, round base 506 for accessing the stopper 31. At the proximal end of the lower part of the body 420, the lower rod 500 includes a protrusion 508 disposed on one of the rims for orientation purposes. In some aspects, the lower rod 500 has a larger diameter than the upper rod 400. In various aspects, the upper rod 400 can have a length of about 25 mm, and the lower rod 500 can have a length of about 40 mm. In some aspects, the flat, round base 506 can have a diameter of about 5 mm. The body 420 of the plunger 42 includes a lower cylindrical portion 422, an upper cylindrical portion 424, and an intermediate portion 440 therebetween. The lower cylindrical portion 422 has a smaller diameter than the upper cylindrical portion 424 and is configured to fit with the restrictor 38. In some embodiments, the lower cylindrical portion 422 can have an outer diameter of about 8 mm, and the upper cylindrical portion 424 can have an outer diameter of about 10 mm. At its distal end, the upper cylindrical portion 424 includes a bayonet 450 having a semi-rectangular U-shaped shape 452 configured to couple with the upper housing 20. At its distal end, the upper cylindrical portion also includes a spring guide 454, and in some aspects, includes two spring guides spaced apart and facing each other and configured to facilitate the movement of the plunger spring 44. In some embodiments, the upper cylindrical portion 424 includes two bayonets 450 spaced apart from each other.The middle part 440 includes a lug 430, and in some embodiments, two lugs spaced apart from each other and facing each other, and is configured to prevent the plunger 42 from firing until the auto-injector 12 is actuated. The body 420 of the plunger 46 also extends from an upper cylindrical portion 424 to a lower cylindrical portion 422 and includes an opening 460 configured to receive the plunger spring 44. In some embodiments, the plunger 42 is monolithic.

[0068] In various embodiments, the housing upper part 20 is coupled to the housing 18 at the proximal end, and at the distal end, the housing upper part 20 is coupled to the housing upper insert 22. One embodiment of the housing upper part 20 is shown in FIGS. 14A - 14B. The housing upper part 20 includes a tubular substantially elliptical body 530 having a proximal opening 541, a distal opening 543, a proximal edge 536, a distal edge 538, and wings 542. In various aspects, the body 530 can have an elliptical profile, the profile major axis d1 of the elliptical profile is about 28 mm, and the minor axis d2 is about 25 mm. In other aspects, the length of the body 530 can be about 15 mm. The wings 542 are disposed at the proximal edge 536 of the tubular body 530, and the wings 542 have a retaining clip 544 configured to snap onto the housing 18. In some aspects, the retaining clip 544 has a clip body 546 attached to the proximal edge of the wing 542 and a snap portion 548 at the distal edge 549 of the retaining clip 544. Surrounding the retaining clip 544 is a substantially square notch 550, which, together with the retaining clip 544 and the snap portion 548, is configured to secure the housing 18. In some aspects, the notch 550 forms a U - shape around the retaining clip 544. In other aspects, the tubular body 530 of the housing upper part 20 includes two wings 542 spaced apart from each other and facing each other. In many aspects, the wings 542 can have a length of about 15 mm.

[0069] In various aspects, at the proximal edge of the tubular body 530, the housing upper portion 20 comprises a locking mechanism 552 for the plunger 42. The mechanism 552 comprises a platform 554, a frame 566 around the notch, and an alignment guide 560. The frame 566 abuts against a tab 565, which projects inwardly the tubular body 30 configured to securely hold the housing upper insert 22. In some aspects, the mechanism 552 includes four frames 566 around four notches 564, with each tab 565 and two alignment guides 560 all spaced apart from each other. The platform 554 comprises a lower stage 556 disposed adjacent to the wing 542, a bayonet upper surface 558 coupled to the bayonet 450 of the plunger 42, a longer tooth projection 561 and a shorter tooth projection 562, all configured to receive and fix the upper cylindrical portion 424 of the plunger body 420. In other embodiments, the tubular body 530 includes an alignment guide 560 disposed intermediate between the lower stage 556 and the distal edge 538. In some aspects, the tubular body 530 includes two alignment guides 560 facing each other at a spaced apart interval. In various aspects, the housing upper portion 20 is monolithic.

[0070] In many embodiments, the upper housing 20 is coupled to the upper housing insert 22. One embodiment of the upper housing insert 22 is illustrated in FIGS. 15A - 15C. The upper housing insert 22 includes a convex, substantially elliptical upper portion 600 and a tubular body 602 attached to the elliptical upper portion 600 at the distal end 612. In various aspects, the elliptical upper portion 600 can have a substantially elliptical profile, where the major axis d1 of the elliptical profile is about 28 mm and the minor axis d2 is 25 mm. At the proximal end, the tubular body 602 has a proximal opening 614 configured to couple with the upper housing 20. In various aspects, the tubular body 602 is defined by a wall 603 and includes a notch 604 disposed towards the proximal end of the wall 603 and configured to receive the tab 565 of the upper housing 20. In some embodiments, the height of the wall 603 is about 13 mm, and the wall 603 further includes a V - shaped compliance slot 610 and a V - shaped orientation mechanism 606 having two ramps 607 at the proximal edge 615 of the tubular body 602. In various embodiments, the wall 603 includes four notches 604, two slots 610, and two orientation mechanisms 606. Internally, the tubular body 602 includes a substantially alignment guide 624. The upper housing insert 22 further includes cylindrical, spaced - apart, U - shaped plunger spring wells 620. At its distal end 626 (not shown), the spring well 620 is centrally located and attached to the upper convex portion 600. In various aspects, the spring well 620 can have an outer diameter of about 7 mm. The spring well 620 is configured to receive the upper rod 400 of the plunger 42 and the plunger spring 44. In various embodiments, the upper housing insert 22 is monolithic.

[0071] The plunger spring 44 is shown in one embodiment of FIG. 16B. The plunger spring 44 is disposed in the upper housing insert 22. When the auto-injector 12 is in use, the plunger spring 44 engages the plunger 42 to push the syringe stopper 31 and release a material, such as a drug, from the syringe or container of the auto-injector 12. In some embodiments, when extended, the length of the plunger spring 44 can be about 58 mm and the outer diameter can be about 4 mm.

[0072] Skin sensor lock Internally, the removable cap 14 has a cam 104 that drives a skin sensor insert (SSI) 34 around the inside of the skin sensor when the cap 14 is assembled to the auto-injector 12. When the SSI rotates, its internal lug or pin 200 engages under the angled locking surface of a modified U-shaped slot or reverse J-shaped slot on the surface of the carriage 40. The SSI has an external lug or external retaining pin 202 that engages the clip slot 160 of the skin sensor 32. Thus, when the auto-injector is configured for storage and is subject to a drop or impact, the skin sensor 32 is prevented from moving under inertial forces by the load path skin sensor clip slot 160 - SSI external pin 196 - SSI internal lug 200 - carriage 40 - restraint 38 - housing 18. When the cap 14 is removed, the cam 104 releases the SSI 34 from its locked position. The SSI 34 returns to the unlocked position by the action of the skin sensor or drive spring 36 and the inclined surfaces of the modified U-shaped slot or reverse J-shaped slot of the carriage 40.

[0073] Self-injector 12 that actuates the syringe at the injection site, when pressed against the injection site, the skin sensor 32 retracts therein, starts the operation sequence, and causes the needle 28 to appear. The movement of the self-injector 12 relative to the skin sensor 32 is affected by a threshold value where the user needs to first apply a high force of 23 N to start the operation, and then the force can be reduced to 9 N. The threshold force is generated by the interaction of the cam surface 171 of the skin sensor that drives the collar 16. The movement of the collar 16 is resisted by the reverse-angle pair of surfaces between the collar 16 and the carriage 40 that are held in contact by the skin sensor or the drive spring 36. In some embodiments, the reverse-angle surfaces are the surface 64 of the collar 16 and the surface 233 of the carriage 40.

[0074] When the threshold is exceeded, the internal mechanism of the self-injector controls the start of injection according to the needle insertion depth. When the self-injector 12 is pressed against the injection site, the skin sensor 32 compresses the skin sensor spring. This skin sensor spring acts on the collar that applies torque to the carriage component 40 via the helical cam 228 of the carriage 40, and its rotation is controlled by the mechanism inside the skin sensor 32, for example, the skin sensor insert 34.

[0075] When the skin sensor 32 is fully pressed down to the target needle insertion depth, the carriage 40 is released and rotated, whereby the plunger 42 rotates. The plunger 42 is held against the force of the injection spring or the plunger spring 44 by the bayonet mechanism 558 in the upper part of the housing 20, and when rotated, it can move freely under the injection spring or the plunger spring 44, driving the stopper 31 in the syringe or container 30 and discharging the dosage. The syringe or container 30 is suspended at the center of the carriage 40 by a restraint 38 that transmits the needle insertion and injection load to the housing 18. The restraint 38 has two feedback arms 300 that are flicked by the plunger 42 when the plunger 42 passes through, thereby creating an audible / tactile feedback indicating that the dosage has been delivered.

[0076] Withdrawal of the syringe from the injection site When the injection is complete and time is allowed for the dose to diffuse, the user withdraws the autoinjector 12 from the injection site. When the autoinjector 12 is withdrawn, the needle 28 is withdrawn and the skin sensor 32 advances to cover it. When the needle 28 is free, the skin sensor 32 is locked in a position advanced (compared to the starting position) by further rotation of the carriage 40 under the torque generated by the skin sensor spring - collar - helical cam system, preventing any contact with the contaminated sharp. This advanced position also prevents the cap 14 from being properly replaced. In this state, the stopper 31 and the red plunger 42 are visible through the window of the autoinjector, further indicating that the autoinjector has been used properly.

[0077] The cap and rigid needle shield removal operations are shown in one embodiment of FIGS. 18A - 18C. FIG. 18A shows a syringe or container 30 housed within a flexible needle shield 26 surrounded by a rigid needle shield 24. FIG. 18A also shows a cap assembly 13 with a removable cap 14 and a cap insert 15. The clip 128 of the cap insert 15 engages the rigid needle shield 24 when the autoinjector 12 is assembled as shown in FIG. 18B. As shown in FIG. 18C, when the cap 14 is removed, the clip 128 of the cap insert 15 catches on the end of the flange 27 of the rigid needle shield 24 and removes it.

[0078] The skin sensor lock operation is shown in one embodiment of FIGS. 19A through 19D. FIG. 19A illustrates the start of the assembly of the skin sensor 32 and the cap 14. During the assembly of the cap 14, the cam 104 of the cap 14 engages and rotates with the cam 198 of the skin sensor insert 34. FIG. 19B is a cutaway view showing the cap cam 104 that is first in contact with the skin sensor insert cam 198. FIG. 19C shows the fully assembled cap including the skin sensor insert, and the skin sensor. FIG. 19D is a cutaway view showing the cap cam 104 fully engaged with the local skin sensor insert cam 198. In the embodiment shown in FIG. 19D, the skin sensor insert 34 is rotated such that its internal lug or pip 200 engages the locking mechanism of the carriage 40. When the cap 14 is removed, the skin sensor spring 36 drives the skin sensor insert 34 down the incline of the reverse J rib or rail 236 of the carriage 40 to disengage it from the carriage locking mechanism. The skin sensor spring 36 is illustrated in one embodiment of FIG. 16A. In some aspects, when extended, the skin sensor spring 36 can have a length of about 75 mm and an outer diameter of about 17 mm.

[0079] Figures 20A through 20E illustrate one embodiment of the operation of the skin sensor assembly. Before the assembly operation is initiated, the skin sensor insert external retaining pin 202 needs to engage with the angled skin sensor clip slot within the skin sensor 32. As a result, the skin sensor insert 34 is constrained before this operation is initiated. In Figure 20A, the skin sensor insert 34 is shown before the skin sensor insert pin 200 moves to the reverse J rib of the carriage 40. In Figures 20B and 20C, when the skin sensor is pushed in, the skin sensor insert pin 200 rubs along the cam surface 166 of the skin sensor, causing the skin sensor insert to rotate and engage the internal lug 200 with the carriage lock mechanism. In Figures 20D and 20E, the skin sensor insert pin 200 moves to the U-shaped angled channel or slot 238 of the reverse J rail. This is achieved by continuing to push the skin sensor 32 into the sub-assembly, and the skin sensor insert pin 200 is pushed into the U-shaped slot 237.

[0080] Figures 21A through 21E illustrate one embodiment of the activation threshold showing the interaction between the skin sensor 32, the color 16, and the carriage 40. Figure 21A shows the skin sensor 32 in a ready-to-use state, the color slot 148 of the housing, and the carriage 40. Figure 21B shows the initial movement of the skin sensor 32. Figure 21C shows further movement of the skin sensor 32 where the skin sensor cam 166 rotates the color, slides the color threshold surface 64 beyond the carriage threshold surface 233, and generates a threshold reaction force. In the embodiment of Figure 21D, at the release point from the threshold surface between the color threshold surface 64 and the carriage point 231, the color 16 rotates and the threshold surfaces slip past each other at the carriage point 231 and the color point 63. In the embodiment of Figure 21E, after the threshold, in the needle insertion stage, the color 16 is moving to the main helical cam 228 of the carriage 40. The force from the drive spring 36 on the skin sensor or the color 16 generates torque on the carriage 40. In this embodiment, the skin sensor 32 is disengaged from the color drive cam 66 and the color 16 is now against its running surface 68 within the housing 18.

[0081] In the embodiment of Figure 22, to rotate the carriage 40, a skin sensor spring 36 (not shown) applies a load to the helical form 228 of the carriage 40 via the color 16. The rotation of the carriage 40 can be blocked by a stop rib or rail 232 that contacts the skin sensor insert pin 200. In this embodiment, the skin sensor insert pin 200 is shown at the limit of insertion prior to transitioning to the injection stage. At this stage, if the user stops the insertion of the autoinjector and withdraws the needle 28 before transitioning to the injection stage, the skin sensor 32 advances but is not locked. In subsequent attempts, the autoinjector will operate but there is no threshold force required to activate it.

[0082] In the embodiments illustrated in FIGS. 23A and 23B, the auto-injector 12 is shown at the transition point to the start of the injection phase. In FIG. 23A, the force of the drive or skin sensor spring 36 (not shown) exerts torque on the carriage 40. The skin sensor insert lug 200 travels onto the injection rib or rail 234 beyond the top of the stop rib 232, thereby enabling the carriage 40 to rotate. In FIG. 23B, the ear or arm 226 of the carriage begins to rotate the plunger 42. The plunger 42 is held in the upper housing 20 via a bayonet mechanism 450. In the embodiments shown in FIGS. 24A and 24B, rotation of the carriage 40 causes the plunger 42 to be pushed out of its bayonet 450 shelf, and the plunger driver 42 freely advances the stopper 31 under a plunger spring (not shown).

[0083] The embodiments shown in FIGS. 25A through 25D illustrate the interaction of the collar, carriage, and skin sensor insert in the lockout phase after the needle has been withdrawn. In FIG. 25A, the collar 16 is still applying torque to the carriage 40. In FIG. 25B, the carriage 40 is reduced or prevented from rotating relative to the carriage injection rib or rail 234 by the skin sensor insert lug 200. FIGS. 25C and 25D show that when the needle has been fully withdrawn, the skin sensor insert lug 200 drops off the end of the injection rib 234 and enters the lockout mechanism.

[0084] In some embodiments, the operation of the delivery device 10 also involves the autoinjector 12, which is also schematically shown in FIGS. 26-36. In the embodiment shown in FIG. 26, the autoinjector 12 is at rest. Prior to the engagement between the cap cam 104 and the W-shaped cam 198 of the skin sensor insert 34, the parallelogram lug 200 of the skin sensor insert 34 is positioned at the bottom of the U-shaped slot of the reverse J rib 236 of the carriage 40 under the downward load from the skin sensor spring 36 (not shown). The upper end of the skin sensor spring 36 acts on the collar 16 to maintain the threshold mechanism in the engaged state. The skin sensor spring 36 (not shown) acts upward on the collar 16 and downward on the skin sensor insert 34.

[0085] In the embodiment of FIG. 27, the autoinjector 12 is also stationary in the storage state. The lug 200 of the skin sensor insert 34 is pushed to the right by the action of the cap cam 104, engaging the skin sensor insert lug 200 with the locking mechanism of the carriage 40. Since the collar 16 is engaged at the bottom of the carriage cam 228 (not shown), the carriage 40 cannot rotate. The skin sensor spring 36 (not shown) acts upward on the collar 16 and downward on the skin sensor insert 34. The plunger 42 bears the load from the injection or the plunger spring 44 (downward in this figure, not shown) and is held by the upper housing 20.

[0086] In FIG. 28, when the cap is removed, the skin sensor insert 34 is released, and the skin sensor insert 34 is pushed out of the carriage 40 locking mechanism by the skin sensor spring 36 and the angled slope of the locking mechanism of the carriage 40 (the same state as before final assembly). The embodiment of FIG. 29 shows the first movement of the skin sensor 32. The threshold force mechanism is overcome. The lug 200 of the skin sensor insert 34 is leaving the U-shaped slot 237 of the carriage 40. The collar 18 now applies torque to the carriage 40, but the carriage has not yet moved.

[0087] Figure 30 shows the needle insertion stage. At this stage, color 16 moves under the skin sensor spring 36 to the information and drives the carriage 40 rotatably. When the stop rail 232 contacts the skin sensor insert lug 200, the rotation of the carriage 40 stops. The upper ear or arm 226 of the carriage has rotated to the plunger lug 430 (not shown). Further, the insertion of the needle compresses the skin sensor spring 36.

[0088] The embodiment of Figure 31 shows an interrupted insertion that occurs when the user withdraws the autoinjector 12 before fully inserting the needle 28. In this embodiment, the carriage 40 cannot rotate. The skin sensor 32 covers the needle 28 simultaneously with the withdrawal of the autoinjector 12. The skin sensor is not locked out, allowing a second attempt at insertion. In some aspects, this state may or may not occur and is not part of the normal usage sequence. The skin sensor 32 can protrude further from the body of the autoinjector 12 than the starting position.

[0089] The embodiment of Figure 32 shows the autoinjector 12 transitioning to the injection stage. The skin sensor insert lug 200 is high enough to clear the stop rail 232, allowing the carriage 40 to rotate. At the last point before the carriage rotates freely, the maximum spring compression within the device is reached, and the autoinjector 12 is in an instantaneous state.

[0090] Figure 33 shows the operation of the autoinjector 12 in the injection stage. To start the injection, the plunger 42 is released. The needle 28 is fully inserted, and the skin sensor insert lug 200 has passed through the stop rail or rib 232. The color 16 drives the carriage 40 freely to rotate again until it is fully inserted or until the injection rib 234 contacts the skin sensor insert lug 200. This rotation of the carriage also frees the plunger 42 from the upper part 20 of the housing (the plunger 42 is shown in an instantaneous state about to start moving).

[0091] The embodiment shown in FIG. 34 shows the complete injection stage. At this stage, the stopper 31 reaches its end stop. The injection or plunger spring 44 drives the plunger 42, and thus the plunger, to inject the dose. In some embodiments, when the auto-injector 12 is configured to fully discharge, an injection end stop occurs where the stopper 31 reaches the bottom of the syringe or container 30. In other embodiments, when the auto-injector 12 is configured to partially discharge, an injection end stop occurs when the plunger 42 stops on the restrictor.

[0092] In the embodiment of FIG. 35, the skin sensor 32 is extended. For example, when the user withdraws the needle from the leg, the skin sensor spring 36 pushes out the skin sensor 32. The carriage 40 is prevented or reduced from rotating as the skin sensor insert lug 200 moves against the insertion or injection rib 2324, so the carriage 40 cannot rotate and the collar 18 cannot move.

[0093] FIG. 36 shows a skin sensor 32 lockout. The skin sensor insert lug 200 clears the complete insertion or injection rail 234, allowing the carriage 40 to make its final rotation. The collar 18 drives the carriage 40 through that final rotation. The auto-injector 12 is now locked so that it will not move even if the skin sensor 32 is pushed.

[0094] The embodiments of FIGS. 37A - 37E illustrate the entire cycle of the injection phase using the delivery device 10 described in this application. In some embodiments, the delivery device 10 can be an auto - injector 12. FIG. 37A shows the auto - injector 12 in its initial storage state. FIG. 37B shows the auto - injector 12 with the cap removed and positioned against an injection site, e.g., the skin surface. FIG. 37C shows the auto - injector 12 with the safety system activated, the needle inserted into the injection site 700, and the plunger 42 (not shown) released. In FIG. 37D, the plunger 42 descends and connects with the stopper 31, delivering the drug dose from the container or syringe 30 through the needle 28. FIG. 37E shows the auto - injector after the skin sensor 32 has returned to its starting position and covered the needle 28. The device components (e.g., needles, caps, drugs, etc.) can be sterilized.

[0095] In various embodiments, one or more components of the device for injecting a drug can be sterilized by radiation in a final packaging sterilization step. Final sterilization of the product ensures a greater degree of sterility than a process such as an aseptic process that requires individually sterilizing the individual product components and assembling the final package in a sterile environment. In some embodiments, one or more components of the device can be assembled individually.

[0096] In various embodiments, gamma rays can be used in the final sterilization process, including using the ionizing energy from gamma rays that penetrate deeply into the device. Gamma rays are very effective at killing microorganisms, leave no residues, and do not have enough energy to impart radioactivity to the device. Gamma rays can be used when the device is in the package and gamma sterilization does not require a high - pressure or vacuum state, so there is no stress on the package seal or other components. Further, gamma rays eliminate the need for a permeable packaging material.

[0097] In various embodiments, an electron beam (e-beam) can be used to sterilize one or more components of a device. E-beam radiation is a type of ionizing energy and is generally characterized by low transmittance and high dose rate. E-beam irradiation is similar to gamma processing in that it changes various chemical and molecular bonds upon contact, including the reproductive cells of microorganisms. The beam generated for e-beam sterilization is a concentrated stream of high-charge electrons generated by the acceleration and conversion of electricity. E-beam sterilization can be used, for example, when the agent is in gel form. To sterilize the agent and / or one or more components of the device, other methods can also be used, including, but not limited to, gas sterilization such as ethylene oxide or steam sterilization.

[0098] One or more components of the device can be made from materials such as polyurethane, polyurea, polyether (amide), PEBA, thermoplastic elastomer olefin, copolyester, styrene-based thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with a high non-ferrous metal content, metals with a relatively low ratio of iron, carbon fiber, glass fiber, plastic, ceramic, or combinations thereof.

[0099] It will be apparent to those skilled in the art that various modifications and changes can be made to the various embodiments described herein without departing from the spirit or scope of the teachings herein. Accordingly, the various embodiments are intended to cover other modifications and variations of the various embodiments within the scope of the present teachings.

Claims

1. In a device for injecting a drug, a housing having a proximal end, the housing having a container disposed therein, the container being configured to hold a drug, the container having a needle at its proximal end and having a stopper disposed within the container, the housing; a plunger having a distal end and a proximal end, the proximal end of the plunger being configured to engage the stopper, the distal end of the plunger being configured to engage a first elastic member, moving the stopper within the container to inject the drug from the container and discharge it from the needle, the plunger; a carriage having at least a portion of the container disposed therein, the carriage being rotatable relative to the housing, the carriage; a collar having a distal end and a proximal end, the distal end of the collar engaging the carriage and causing rotation of the carriage, the proximal end of the collar being configured to engage a second elastic member, the collar; a skin sensor having a distal end and a proximal end, the distal end of the skin sensor being configured to engage the second elastic member, the proximal end of the skin sensor being configured to contact an injection site, the skin sensor; a cap configured to engage the proximal end of the housing to prevent the skin sensor from compressing the second elastic member; comprising a device for injecting a drug, wherein the carriage has a carriage threshold surface and the collar has a collar threshold surface, and when the second elastic member is compressed, the second elastic member rotates the carriage via the carriage threshold surface to the collar threshold surface.

2. The device according to claim 1, wherein the cap is removed from the housing, an injection force is applied to the skin sensor, the second elastic member is compressed, engages the collar, rotates the carriage in the collar, and when the carriage rotates, the first elastic member engages the plunger to inject the drug from the container and discharge it from the needle.

3. (i) The device is disposable and comprises a single dose of medicament, (ii) the skin sensor is configured to retract when the needle is inserted and to surround and extend around the needle after the medicament has been injected, or (iii) the first elastic member is in a compressed state before an injection force is applied to the skin sensor, the device according to claim 1.

4. The distal end of the plunger comprises a restraint member, the restraint member being configured to reduce or prevent movement of the plunger and to hold the first elastic member in a compressed state, the device according to claim 2.

5. Rotation of the carriage causes rotation of the restraint member of the plunger, decompressing the first elastic member and causing the plunger to move the stopper within the container to inject the medicament from the container and discharge it from the needle, the device according to claim 4.

6. The device according to claim 1, further comprising a needle shield covering the needle at the proximal end.

7. The needle shield comprises a flexible material relative to the housing and / or a rigid material relative to the first or second elastic member, the device according to claim 6.

8. The device further comprises a cap insert coupled to the cap, the cap insert having a capture member for the needle shield, the needle shield protecting the needle at the proximal end, the capture member being configured to remove the needle shield of the needle when the cap is removed from the housing, the device according to claim 6.

9. The device according to claim 8, further comprising a skin sensor insert coupled to the skin sensor, the skin sensor insert being configured to couple with the cap insert.

10. The skin sensor insert comprises a locking surface configured to lock with a locking surface of the cap before the cap is removed, the device according to claim 9.

11. The locking surface of the skin sensor insert is a W-shaped cam, the device according to claim 10.

12. The locking surface of the cap is a triangular cam that engages the W-shaped cam of the skin sensor insert, the device according to claim 11.

13. The device according to claim 1, further comprising an upper housing coupled to the housing and an upper housing insert coupled to the upper housing.

14. The device according to claim 13, wherein the first elastic member is a spring configured to couple the upper housing insert to the plunger.

15. The device according to claim 1, wherein the second elastic member applies torque to the carriage and rotates the carriage when compressed.

16. The device according to claim 1, wherein the agent includes an analgesic, an anti-inflammatory substance, a hormone, a beta agonist, an alpha agonist, a beta antagonist, an alpha antagonist, a beta antagonist, a benzodiazepine, a glucose regulator, a narcotic, a narcotic antagonist, a cholinergic agonist, an anti-cholinergic agonist, a muscarinic agonist, a muscarinic antagonist, a steroid, a chloride salt, an iodide salt, a cholinesterase reactivator, a cholinesterase agonist, an antibacterial agent, an antiarrhythmic agent, a vasodilator, a vasoconstrictor, an anticoagulant, a cardiovascular agent, an anti-Parkinson's disease agent, an antipsychotic agent, an immunosuppressant, an antihistamine, or a combination thereof.

17. When the skin sensor is displaced in the direction of its distal end, the needle protrudes from the skin sensor. After the needle has protruded a predetermined amount from the skin sensor, the skin sensor is further displaced in the direction of its distal end so that the injection of the agent is initiated, according to the device of claim 1.

18. The skin sensor is configured such that when it is displaced in the direction of its distal end, the needle protrudes from the skin sensor and the injection of the agent is initiated. After the injection of the agent is completed, when the skin sensor returns to its initial state, the skin sensor is locked so that it cannot be displaced again, according to the device of claim 1.

19. A device for injecting an agent, the device comprising: A housing having a proximal end, the housing having a container disposed within the housing, the container being configured to hold an agent, the container having a needle at its proximal end, the needle being protected by a needle shield at its proximal end, and the container having a stopper disposed within the container. A plunger having a distal end and a proximal end, wherein the proximal end of the plunger is configured to engage with the stopper, and the distal end of the plunger is configured to engage with a first elastic member, and the stopper is moved within the container to inject a drug from the container and discharge it from the needle. A plunger, A carriage having at least a portion of the container disposed therein, wherein the carriage is rotatable with respect to the housing. A carriage, A collar having a distal end and a proximal end, wherein the distal end of the collar is configured to engage with the carriage, causing rotation of the carriage, and the proximal end of the collar is configured to engage with a second elastic member. A collar, A skin sensor having a distal end and a proximal end, wherein the distal end of the skin sensor is configured to engage with the second elastic member, and the proximal end of the skin sensor is configured to contact the injection site. A skin sensor, A cap configured to engage with the proximal end of the housing so as to prevent the skin sensor from compressing the second elastic member, A cap insert coupled to the cap, the cap insert having a capture member for the needle shield, the capture member being configured to remove the needle shield by removing the cap from the proximal end of the housing. A cap insert, Comprising, The carriage has a carriage threshold surface, the collar has a collar threshold surface, and when the second elastic member is compressed, the second elastic member rotates the carriage via the carriage threshold surface to the collar threshold surface. A device for injecting a drug.

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