Device for injecting a medicament Device for injecting a medicament

Abstract

A device for injecting a medicament is provided. The device has a housing with a container for containing a medicament within the housing. The container has a needle and a stopper at a proximal end thereof. The device includes a plunger engageable at one end with the stopper. At an opposite end, the plunger is engageable with a first resilient member to move the stopper within the container to inject the medicament from the container. The device includes a collar having a distal end and a proximal end, the distal end being engageable with a carriage and causing rotation thereof, and the proximal end being engageable with a second resilient member. The second resilient member can be engageable with a skin sensor having a distal end and a proximal end. At the proximal end, the skin sensor can contact an injection site. The housing has a cap that can reduce or prevent movement of the skin sensor.

Description

[0001] This application is a divisional application of the applicant’s patent application No. 201980029950.8 (PCT / IB2019 / 000243) entitled “Apparatus for injecting drugs and method of use”, filed on March 12, 2019. Technical Field

[0002] This application relates to a device for injecting drugs. Background Technology

[0003] An autoinjector is a drug delivery device that facilitates the administration of a predetermined dose of medication. Autoinjectors are particularly beneficial for patients self-administering or for untrained personnel administering medication.

[0004] Autoinjectors typically allow users greater control over the injection process, enabling them to choose the injection site and administer medication. This increased control can reduce needle-related hesitation, pain, and anxiety, and can also improve patient adherence to specific medications.

[0005] Autoinjectors are typically used to treat acute or chronic conditions. For example, in chronic conditions such as diabetes, autoinjectors can maintain a specific dose of insulin. The added control provided by autoinjectors, along with the specific insulin dose, enhances patient adherence and prevents the administration of incorrect dosages.

[0006] In acute conditions, such as the acute treatment of migraines, some patients are instructed to receive an emergency injection of a selective serotonin receptor agonist, such as sumatriptan, during a migraine attack. Even when patients are facing pain and visual disturbances often associated with debilitating migraines, autoinjectors allow patients to take control and administer medication precisely to relieve migraines.

[0007] Typically, an autoinjector device has one or more specific doses of medication pre-loaded in a container such as a syringe. The syringe is connected to a needle for the patient to puncture the skin, and to a plunger to expel the medication from the syringe through the needle to the injection site.

[0008] After the injection has taken place and the medication has been expelled from the syringe, some autoinjectors have needle protectors or skin sensors that can be deployed and cover the needle after injection to help reduce or prevent further needle pricks or reuse of the needle.

[0009] Sometimes, autoinjectors with needle protectors or skin sensors can be unreliable, and the needle protectors or skin sensors may be improperly deployed or blocked, preventing drug administration. This can be a serious problem, especially in life-threatening situations where medication is urgently needed.

[0010] Therefore, there is a desire to provide new devices and methods for injecting drugs that offer reliable and safe delivery to users. Devices and methods for injecting drugs that allow for accurate delivery to the injection site (even by untrained personnel) would be most beneficial. Summary of the Invention

[0011] Novel devices and methods for injecting drugs are described, enabling reliable and safe delivery to users. The provided devices and methods allow for accurate delivery of drugs to the injection site and can be used even by untrained personnel.

[0012] The described delivery device and method include a housing having a proximal end and a distal end. The housing has a container disposed therein, the container being configured to contain a drug. In some aspects, the container may be a syringe and has 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 may have both a distal and a proximal end. In some embodiments, at the proximal end, the plunger is configured to engage with the stopper, and the distal end of the plunger is configured to engage with an energy storage member and move the stopper within the container to inject the drug from the container away from the needle. The energy storage member may be a first and / or a second resilient member. In some aspects, the first resilient member may be a spring. The device also has a carriage having at least a portion of the container disposed therein, the carriage being 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 cause rotation of the carriage, and the proximal end of the collar being configured to engage a second resilient member, which in some aspects may be a spring. The device includes a skin sensor having a distal end and a proximal end. The distal end of the skin sensor is configured to engage with a second elastic member, and the proximal end of the skin sensor is configured to contact an injection site. When the device is in its initial storage state, a cap configured to engage the proximal end of the housing reduces or prevents movement of the skin sensor.

[0013] In some embodiments, when the cap is removed from the device housing and an injection force is applied to the skin sensor, the second resilient member is compressed and engages the collar, causing the collar to rotate the carriage. As the carriage rotates, the first resilient member engages the plunger to inject the medication from the container away from the needle.

[0014] In several aspects, the device disclosed herein is disposable and includes a single-dose medication. In some aspects, the skin sensor is configured to retract during injection of the needle and extend after the medication is injected to surround the needle to protect the user from accidental needlestick injuries. In other aspects, a first resilient member, which may be a spring, is compressed before an injection force is applied to the skin sensor. In other embodiments, the distal end of the plunger includes a restraining member configured to reduce or prevent plunger movement and to hold the first resilient member in a compressed state.

[0015] The rotation of the carriage causes the piston's restraining member to rotate, which releases the first elastic member from compression and allows the piston to move the stopper within the container or syringe to inject the drug from the container away from the needle.

[0016] In several embodiments, the needle tip of the container is protected proximally by a needle shield. The needle shield may be made of a flexible material relative to the housing, and / or may be a rigid material relative to the first or second elastic member.

[0017] In many respects, the device may also include a cap insert coupled to the cap. The cap insert may have a capturing member for the needle shroud, the capturing member being configured to remove the needle shroud from the housing when the cap is removed.

[0018] In some aspects, the device also includes a skin sensor insert coupled to a skin sensor, the skin sensor insert being configured to engage with a cap insert. In other aspects, the skin sensor insert is not configured to engage with a cap insert. In other aspects, the skin sensor insert includes a locking surface configured to lock with a locking surface of the cap prior to cap removal. In several 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 coupled to the W-shaped cam of the skin sensor insert. In other aspects, the locking surface is a U-shaped slot 237 and a skin sensor insert surface, as described below.

[0019] This disclosure also provides a method of injecting a dose of drug, the method comprising injecting a dose of drug at an injection site using an injection device, the injection device comprising: a housing having a proximal end, the housing having a container disposed within the housing, the container being configured to contain a drug, 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 being configured to engage a first resilient member and move the stopper within the container to inject the drug from the container away from the needle; a carriage having at least a portion of a container disposed therein, the carriage 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 and cause rotation of the carriage, the proximal end of the collar being configured to engage a second resilient 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 resilient member, the proximal end of the skin sensor being configured to contact the injection site; and a cap configured to engage the proximal end of the housing to reduce movement of the skin sensor. In several embodiments, the cap is removed from the housing before injecting the dose of drug at the injection site. Removing the cap reveals a skin sensor, which can be applied to the injection site with injection force to allow the needle to pierce the patient's skin, thus enabling the injection of medication from the container through the needle. The needle is then withdrawn from the injection site. In several embodiments, applying the skin sensor to the injection site and withdrawing the needle from the injection site are performed manually.

[0020] This disclosure also provides a removable cap for a device for injecting medication. In some embodiments, the cap may be the cap of an autoinjector and may include a tubular body having a generally 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 a housing of the device. In several aspects, the cap also includes a gripping feature at the distal end of the tubular body and a locking lug or cam for providing a locking mechanism for the device. In other aspects, the cap includes a recess for retaining the housing of the device. In several aspects, the cap insert of the device includes a cap, a cap insert body, and a capture member for attaching a needle shroud to a container disposed within the housing of the device. In many aspects, the capture member is a tubular shaft centrally disposed on the cap cap along a longitudinal axis, the tubular shaft also including a clamp configured to engage the needle shroud. The cap insert also includes two arms having opposing concave surfaces and disposed around the capture member of the cap insert configured to engage the proximal end of the cap.

[0021] In several embodiments, the cap is configured to engage the proximal end of the housing and the skin sensor, the cap having a locking surface configured to lock with the skin sensor to prevent movement of the skin sensor. In some aspects, the locking surface of the cap includes a recess or protrusion, and the skin sensor further includes a skin sensor insert that includes a recess or protrusion that locks with the recess or protrusion of the cap's locking surface. In other aspects, the recess or protrusion of the cap is a triangular cam, and the recess or protrusion of the skin sensor insert is a W-shaped cam configured to engage with the triangular cam of the cap. In many aspects, the skin sensor insert includes a lug configured to engage a U-shaped slot in a carriage and / or a slot in the skin sensor.

[0022] In several aspects, the carriage of the device described in this disclosure includes a tubular body having a proximal end and 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 edge, an upper edge and two arms extending from the upper edge, the arms facing each other to form a U-shape with the upper edge and the carriage configured to receive a drug container. In many aspects, the carriage may be integral. In many aspects, the carriage includes a stop track, an injection track and a locking or inverted J-shaped track at its proximal end, all tracks being spaced apart from and adjacent to each other, wherein the stop track is disposed between the locking track and the injection track. In several embodiments, the locking track includes a U-shaped slot configured to engage a lug of a skin sensor insert to reduce or prevent movement of the skin sensor in the event of a drop or impact to the device. In many aspects, when the cap is removed from the housing, a second resilient member drives the needle protector insert downward along the inclination of the U-shaped slot and disengages it from engagement with the locking track.

[0023] In many embodiments, the skin sensor insert further includes an external pin, and the skin sensor includes an external slot and a cam surface configured to allow the external pin of the skin sensor insert to extend along the cam surface of the skin sensor and engage with the slot of the skin sensor. In some aspects, the skin sensor also includes a cam at its distal end for engaging with a collar. In other aspects, the collar also includes a threshold surface at its distal end, and the cam of the skin sensor rotates the threshold surface of the collar and engages with a carriage to generate a threshold force varying from about 9 N to about 23 N.

[0024] This disclosure also provides a method for injecting a dose of a drug, the method comprising injecting a dose of the drug at an injection site using an injection device, the injection device comprising: a housing having a proximal end, the housing having a container disposed within the housing, the container being configured to contain a drug, 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 resilient member and move the stopper within the container to dispense the drug from the container and the needle; and a carriage having at least one of the containers disposed therein. The device comprises: a slide 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 slide and cause rotation of the slide, and the proximal end of the collar being configured to engage a second resilient 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 resilient member, and the proximal end of the skin sensor being configured to contact an injection site; and a cap configured to engage the proximal end of the housing and the skin sensor, the cap having a locking surface configured to lock with a locking surface of the skin sensor to prevent movement of the skin sensor.

[0025] In several embodiments, the carriage of the device described in this disclosure has at least a portion of a carriage engaging a restraint, the restraint being at least partially disposed within the carriage and housing a container therein, the restraint having auditory and / or tactile feedback members to indicate drug dispensing, and the carriage being rotatable relative to the housing. In many aspects, the restraint includes a cylindrical body and a wing member. The cylindrical body of the restraint has a proximal end and a distal end, and is configured to contact the container at the proximal end and a plunger at the distal end. The wing member of the restraint body extends along the longitudinal axis of the cylindrical body of the restraint and includes a feedback arm, the wing body, and a bridging member connecting the body to the wing member. In several embodiments, the restraint is integral.

[0026] In many embodiments, the restraint also includes a retaining clip between a proximal and a distal end of its cylindrical body, the retaining clip being configured to suspend a container or, in some respects, a syringe in a carriage. In some embodiments, the cylindrical body of the restraint has a cutout around the retaining clip of the container, wherein the cutout is generally rectangular and forms a U-shape around the retaining clip of the restraint. In other aspects, the retaining clip is a rectangular piece on the periphery of the circumference of the restraint body. In many aspects, the retaining clip includes a body having a distal end adjacent to the distal end of the restraint body and a proximal end adjacent to the cutout in the restraint body. The body of the retaining clip has a tapered and / or arcuate surface pointing toward an inner surface of the restraint body. In other aspects, the retaining clip also includes a tab portion extending toward an inner surface of the restraint body.

[0027] In several embodiments, the wing body of the restraint's wing member is substantially rectangular. The wing body includes a first surface, a second surface opposite the first surface, and a side surface disposed between the first and second surfaces. The first surface has a feedback arm and a bridging member connected to the wing body, and the second surface may have grooves and ridges. In many respects, the first and second surfaces are substantially rectangular. In other embodiments, the bridging member of the first surface divides the wing body in two, defining an upper wing above the cylindrical body of the restraint and a lower wing below the cylindrical body of the restraint.

[0028] In many embodiments, the feedback arm of the restraint's wing member includes an upper arm, a lower arm, and an elbow joint connecting the upper and lower arms. In other embodiments, the upper arm includes a first end adjacent to a first surface of the upper wing and a second end including a distal end that protrudes beyond the elbow joint to form an L-shape with the lower arm, such that the lower arm is longer than the distal end of the upper arm. In many aspects, the feedback arm extends toward the cylindrical body, forming a U-shape between the upper arm, lower arm, and cylindrical body. In some aspects, the bridging member includes a rectangular arm and a triangular support, wherein the triangular support abuts against the first surface of the lower wing. In several embodiments, the restraint is configured to generate audible and / or tactile sounds, thereby providing a signal indicating that the plunger has been actuated to push medication into the container and out of the needle when it contacts the U-shaped opening of the feedback arm. In many aspects, the feedback arm is flexible relative to the housing, such that the upper portion of the plunger is configured to move through the feedback arm. In other aspects, the upper arm of the feedback arm is configured to extend horizontally away from the restraint body, thereby allowing longitudinal movement of the plunger within the container.

[0029] This disclosure also provides a method for injecting a dose of drug, the method comprising injecting a dose of drug at an injection site using an injection device, the injection device comprising: a housing having a proximal end, the housing having a container disposed within the housing, the container being configured to contain a drug, 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 resilient member and move the stopper within the container to dispense the drug from the container out of the needle; and a carriage having at least a portion engaging a restraint. A restraint is disposed within a carriage and houses the container therein, the restraint having auditory and / or tactile feedback members to indicate drug dispensing, the carriage being rotatable relative to the housing; a collar having distal and proximal ends, the distal end of the collar configured to engage the carriage and cause rotation of the carriage, the proximal end of the collar configured to engage a second elastic member; a skin sensor having distal and proximal ends, the distal end of the skin sensor configured to engage the second elastic member, the proximal end of the skin sensor configured to contact the skin; and a cap configured to engage the proximal end of the housing to prevent movement of the skin sensor.

[0030] Other features and advantages of this disclosure will become apparent from the following detailed description. However, it should be understood that while the detailed description and specific examples indicate various embodiments of this disclosure, they are given by way of illustration only, as various changes and modifications within the spirit and scope of this disclosure will be apparent to those skilled in the art from this detailed description. Attached Figure Description

[0031] Other aspects, features, benefits, and advantages of the embodiments will be apparent in part from the following description, the appended claims, and the accompanying drawings.

[0032] Figure 1 This is a perspective view of a device for injecting drugs, which may be an autoinjector.

[0033] The device is shown assembled and capped;

[0034] Figure 2 yes Figure 1 An exploded view of an embodiment of the device, which may be an auto-injector;

[0035] Figure 3 yes Figure 1 A cross-sectional view of the device;

[0036] Figure 4A and 4B yes Figure 1 A perspective view of the removable cap of the device in the image;

[0037] Figure 4C and 4D They are Figure 4A and 4B Top and bottom views of the movable cap;

[0038] Figure 5A and 5B yes Figure 1 A perspective view of the cap insert of the device in the image;

[0039] Figure 5C and 5D They are Figure 5A and 5B Side and bottom views of the cap insert;

[0040] Figure 6A and 6B yes Figure 1 A perspective view of the housing of the device;

[0041] Figure 6C and 6D They are Figure 6A and 6B The top and bottom views of the shell are shown.

[0042] Figure 7A and 7B yes Figure 2 A perspective view of the skin sensor of an autoinjector;

[0043] Figure 7C and 7D They are Figure 7A and 7B The top and bottom views of the skin sensor shown;

[0044] Figure 8A and 8B yes Figure 3 A perspective view of the skin sensor insert of the device;

[0045] Figure 8C and 8D They are Figure 8A and 8B Top and bottom views of the skin sensor insert shown;

[0046] Figure 9A and 9B yes Figure 2 A perspective view of the carriage of the device in the image;

[0047] Figure 10A and 10B yes Figure 2 A perspective view of the carriage thrust bearing of the device in the middle;

[0048] Figure 11A and 11B yes Figure 2 A perspective view of the collar of the device in the middle;

[0049] Figure 11C and 11D They are Figure 11A and 11B The top and bottom views of the collar shown;

[0050] Figure 12A and 12B yes Figure 2 A perspective view of the constraint mechanism in the device;

[0051] Figure 13A and 13B yes Figure 2 A perspective view of the plunger in the device;

[0052] Figure 13C and 13D They are Figure 13A and 13B The top and bottom views of the plunger shown;

[0053] Figure 14A and14B yes Figure 2 A perspective view of the top of the housing of the device;

[0054] Figure 15A , 15B And 15C is Figure 2 A perspective view of the top insert of the housing of the device;

[0055] Figure 16A and 16B They are Figure 2 A perspective view of the skin sensor spring and plunger spring in the device;

[0056] Figure 17A and 17B They are Figure 3 Perspective and side views of the syringe or container of the device;

[0057] Figure 17C and 17D They are Figure 3 Perspective and side views of the plug in the device;

[0058] Figure 18A and 18B yes Figure 3 A perspective view of the interaction between the cap and the rigid needle guard in an embodiment of the device;

[0059] Figure 18C yes Figure 3 A cross-sectional view of the interaction between the cap and the rigid needle guard in an embodiment of the device;

[0060] Figure 19A , 19B 19C and 19D are Figure 3 A perspective view of the components of an embodiment of the device;

[0061] Figure 20A , 20B 20C, 20D, and 20E are Figure 3 A perspective view of the components of an embodiment of the device;

[0062] Figure 21A , 21B 21C, 21D, and 21E are Figure 3 A perspective view of the components of an embodiment of the device;

[0063] Figure 22 yes Figure 3 A perspective view of the components of an embodiment of the device;

[0064] Figure 23A , 23B And 23C is Figure 3A perspective view of the components of an embodiment of the device;

[0065] Figure 24A and 24B yes Figure 3 A perspective view of the components of an embodiment of the device;

[0066] Figure 25A , 25B 25C and 25D are Figure 3 A perspective view of the components of an embodiment of the device;

[0067] Figure 26 , 27 Numbers 28, 29, 30, 31, 32, 33, 34, 35, and 36 are Figure 3 A schematic diagram of the components of an embodiment of an auto-injector; and

[0068] Figure 37A , 37B 37C, 37D, and 37E are Figure 1 A diagram illustrating the injection phase cycle of an autoinjector.

[0069] Furthermore, the relationships between objects in the diagram may not be drawn to scale; in fact, they may have opposite relationships in size. The diagrams are intended to make the structure of each object clear and understandable; therefore, some features may be exaggerated to show specific characteristics of the structure. Detailed Implementation

[0070] This disclosure can be more readily understood by referring to the following detailed description presented in conjunction with the accompanying drawings. Figure 1 This forms part of the present disclosure. It should be understood that this disclosure is not limited to the specific apparatus, methods, conditions, or parameters described and / or shown herein, and the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to limit the claimed disclosure. The following description is presented to enable any person skilled in the art to make and use this disclosure.

[0071] Although the numerical ranges and parameters used to illustrate the broad scope of this application are approximations, the numerical values ​​described in specific instances are reported as precisely as possible. However, any numerical value inherently contains some error, which is necessarily caused by the standard deviation in their respective test measurements. Furthermore, all ranges disclosed herein should be understood to encompass any and all subranges contained therein. For example, the range "1 to 10" includes any and all subranges between the minimum value of 1 and the maximum value of 10, i.e., all subranges where the minimum value is greater than or equal to 1 and the maximum value is less than or equal to 10, such as 5.5 to 10.

[0072] definition

[0073] When used in the specification and including the appended claims, the singular form and "the" include the plural, and unless the context clearly specifies otherwise, a reference to a particular value includes at least that particular value.

[0074] The scope described herein may be expressed as from “about” or “approximately” a particular value and / or to “about” or “approximately” another particular value. When expressing such a scope, another embodiment includes from one particular value and / or to another particular value.

[0075] For ease of description, spatial relative terms such as "below," "under," "down," "above," and "upper" are used to explain the position of one element relative to a second element. These terms are intended to cover different orientations of the device, in addition to including orientations different from those depicted in the figures. Furthermore, terms such as "first" and "second" are also used to describe various elements, areas, parts, etc., and are not intended to be limiting. Throughout the specification, similar terms refer to similar elements.

[0076] As used herein, the terms “having,” “comprising,” “including,” etc., are open-ended terms that indicate the presence of the stated element or feature but do not exclude other elements or features.

[0077] The term "medicine" includes substances suitable for injection to treat a condition or disease. A medicine may include active pharmaceutical ingredients and excipients.

[0078] The term "proximal end" in an autoinjector or device refers to the end closest to the patient's skin.

[0079] The term "distal" refers to the end furthest from the patient's skin.

[0080] The following headings are not intended to limit this disclosure in any way; embodiments under any heading may be used in conjunction with embodiments under any other heading.

[0081] Reference will now be made in detail to certain embodiments of this application, examples of which are illustrated in the accompanying drawings. Although the present application will be described in conjunction with the illustrated embodiments, it should be understood that they are not intended to limit the present application to those embodiments.

[0082] Device for injecting drugs

[0083] A novel drug delivery device and method for providing reliable and safe injections to users are described. The provided drug delivery device and method allow for precise delivery of drugs to the injection site and can be used even by untrained personnel.

[0084] This application provides embodiments of a delivery device for injecting at least one dose of a drug and related methods of use. The drug may be in liquid form, such as a solution, suspension, emulsion, gel, colloid, or foam.

[0085] The delivery device can be loaded with any medication to be injected. For example, the delivery device can be loaded with one or more doses of medication. Suitable medications include, for example, analgesics, anti-inflammatory agents, hormones, beta agonists, alpha agonists, beta antagonists, alpha antagonists, benzodiazepines (e.g., diazepam), glucose regulators (e.g., insulin, glucagon, glucose), anesthetics (e.g., opioids), anesthetic antagonists (e.g., naloxone), cholinergics, anticholinergics, muscarinic agonists, muscarinic antagonists, steroids, chloride salts (e.g., potassium chloride, sodium chloride, calcium chloride), iodide salts, cholinesterase reactivators, cholinesterase agonists, antibacterial agents, antiarrhythmic agents, vasodilators, vasoconstrictors, anticoagulants, cardiovascular agents, anti-Parkinson's agents, antipsychotics, immunosuppressants, antihistamines, selective serotonin receptor agonists, or combinations thereof. Drugs can be in liquid form, such as solutions, suspensions, emulsions, gels, colloids, or foams.

[0086] In some embodiments, the delivery device includes a novel emergency release pen. In some embodiments, the emergency release pen is a single-use, disposable autoinjector with a pre-filled syringe. In some embodiments, the emergency release pen is configured to allow a patient to self-inject medication, such as glucagon to treat hypoglycemia or naloxone to treat anesthetic overdose. In some embodiments, the emergency release pen is configured in an initial state, wherein a cap covers the skin sensor or needle protector of the emergency release pen. The cap is removed to expose the skin sensor. The user applies injection force to the skin sensor, which ultimately causes the plunger to remove the medication from the container or syringe and the needle to the injection site to deliver the medication.

[0087] After the medication is injected and the needle is withdrawn from the injection site, the skin sensor then returns to the extended position to shield or cover the needle, preventing further use and unwanted skin punctures.

[0088] The delivery device 10 shown may be a single-use autoinjector 12, a device for injecting medication. In various embodiments, the needle and penetration depth of the device can be designed for different volumes of medication and various types of injection. For example, in some embodiments, the autoinjector 12 may be a disposable device, and in some embodiments, it delivers up to 0.3 ml (in some respects 0.4 ml) of low-viscosity formulation to an injection site with an injection depth of 12.7 mm to 16 mm needles. In other embodiments, the device may be designed to deliver volumes larger or smaller than those described above. In many embodiments, the device may be configured for subcutaneous, intramural, epidural, intradermal, intramuscular, intravenous, intraperitoneal, intracardiac, intra-articular, and / or cavernous sinus injections. As discussed further, the needle insertion and withdrawal are manually actuated while the injection is spring-driven. Once the needle is withdrawn, the delivery device protects the needle. The delivery device has at least a dose observation window to allow viewing of the contents of the syringe or medication container before operation, and additional dots or ridges on the housing to limit the risk of rolling off the inclined plane. Unlike many conventional autoinjectors, the delivery device of this disclosure is activated in several ways not by a start or actuator button, but by a skin sensor or needle protector to prevent unwanted needle pricks.

[0089] Reference Figure 1-3 The autoinjector 12 includes a removable cap 14 that covers the skin sensor 32 and functions as a needle shield remover. The autoinjector 12 also includes a housing 18, which is generally cylindrical along its longitudinal axis LL and houses most of the other components of the autoinjector 12 together with a housing top 20. In some embodiments, the housing 18 includes a collar 16 for inserting the skin sensor 32, a syringe or container 30 having a needle 28, and a syringe plug 31 slidably located within the syringe or container 30, all of which are at least partially included in a carriage 40 configured for engagement with a plunger 42. The autoinjector 12 has a proximal end 19 and a distal end 23.

[0090] When the user removes the cap 14, this action automatically removes the needle shield 23 covering the needle 28 of the syringe or container 30. In some embodiments, the needle shield 23 may be made of a rigid material to provide a rigid needle shield 24 protecting the needle 28. In other embodiments, the needle shield 23 may be made of a flexible material to provide a flexible needle shield 26. In still other embodiments, the needle 28 may 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 will not be fully extended but will be partially retracted. In some embodiments, the partially retracted skin sensor 32 is a fail-safe mechanism to prevent mis-injection.

[0091] To administer the medication, the user presses the skin sensor 32 onto the skin at the injection site. This allows the skin sensor to retract fully toward the distal end 21 of the carriage 40. The skin sensor engages the skin sensor spring 36, which engages the collar 16 without rotation. Once the needle 28 has been inserted to the designated depth, the collar 16 engages the carriage 40, causing the carriage to rotate. This rotation of the carriage 40 causes the plunger 42, located at the distal end 21 of the carriage 40, to rotate. The distal end of the carriage has a slot / hole that allows the plunger 42 to extend after the carriage 40 has fully rotated to a position allowing the plunger 42 to pass through a channel present in the carriage.

[0092] 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... Figures 4A-4D As shown in the figure. In this embodiment, the cap 14 has a generally elongated tubular body 14a, which is open at both ends and has a generally elliptical cross-sectional profile. The major axis d1 of the elliptical profile is approximately 28 mm, while the minor axis d2 is approximately 25 mm. At the proximal end, the cap 14 has a proximal opening 90 adapted to receive a cap insert 15 and a clamping recess 102 providing positive clamping retention between the cap 14 and the cap insert 15. Opposite to the proximal opening 90, the cap 14 has a distal opening 91 adapted to connect to the housing 18 via a shaped interface 100, which facilitates removal of the cap from the housing 18 by providing natural withdrawal and thus providing tension on the label when the cap is unscrewed. Externally, the cap 14 includes a gripping feature 103 that helps retain the cap. Internally, the cap 14 includes a locking actuation lug or cam 104 to provide a locking method for activating the autoinjector when the cap 14 is installed and the skin sensor insert 34 is in the locked position. The cap 14 also includes a retaining hole 106, which interacts with a soft positioning protrusion on the housing 18 to enhance cap retention. The length of the tubular body 14a from the proximal end to the retaining hole 106 is approximately 30 mm.

[0093] The cap insert 15 is attached to the cap 14 to cover the opening 90 extending through the proximal end of the cap 14. Figures 5A-5DAn embodiment of the cap insert 15 is shown. In this embodiment, the cap insert 15 includes a flat cap 110 and a cap insert body 114. The flat cap 110 has a generally elliptical shape with dimensions similar to the elliptical cross-sectional profile of the cap 14. The flat cap 110 includes a rigid and / or flexible needle shield capturing member 124, which is centrally positioned on the circular flat cap 110 and projects distally. In some aspects, the rigid and / or flexible needle shield capturing member 124 is shaped as a tubular shaft 126 with a hook 128 configured to engage with and remove the end flange 27 of the rigid needle shield 24 upon removal of the cap 14. The capturing member 124 has a length of approximately 10 mm and an outer diameter of approximately 8 mm. In several aspects, the cap insert body 114 has two arms 115 having opposing concave surfaces and disposed around the needle shield capturing member 124, extending longitudinally along axis CC and spaced apart from each other. Each arm 115 has an upper body 116 and a lower body 118 adjacent to the upper body 116. The upper body 116 of the arm 115 includes a base 117, and a clip feature 120 extends distally from the base 117 along a longitudinal axis CC to provide reliable positive clip retention between the cap 14 and the insert 15. In another embodiment, each clip feature 120 has two arms extending from the base 117, forming a U-shape between them. The lower body 118 of the arm 115 includes a clip hole 122 to provide a positive feature for clamping onto the skin sensor 32.

[0094] In some embodiments, the syringe or container 30 is protected by a flexible needle shield 26 coupled to a rigid needle shield (RNS) 24, such as... Figure 2 As shown in Figure 18a, a flexible needle guard 26 encloses the needle 28 and is surrounded by a rigid needle guard 24, both configured to protect the needle 28 of the syringe or container 30. The rigid needle guard 24 includes a cylindrical tapered surface at the end of the needle 28 and has an end flange 27 for interacting with a hook 128 of the tubular shaft 126 of the cap insert 15. When the cap 14 is removed, the hook 128 engages with the end flange 27 of the rigid needle guard 24 to remove it from the syringe or container 30. In some aspects, when the cap 14 and the cap assembly of the cap insert 15 are removed, the hook 128 of the cap insert 15 can simultaneously remove both the flexible needle guard 26 and the rigid needle guard 24. In some embodiments, the rigid needle guard 24 may have a length of about 25 mm to about 35 mm and an outer diameter of about 5 mm at its distal end.

[0095] To initiate operation of the autoinjector 12, the user removes the cap 14 by pulling and / or twisting. This action causes three key effects: (i) the label attached to both the autoinjector body and the cap 14 is split in two; (ii) the rigid needle shield 24 is pulled out from within the autoinjector 12; and (iii) the skin sensor lock that secures the autoinjector during transport is released. The device label is designed to be affixed to both the device body and the cap simultaneously, so removing the cap tears the label along the contour of the perforation, thus providing evidence of tampering that compromises sterility.

[0096] The cap assembly (cap 14 and cap insert 15) is clamped onto the end flange 27 of the rigid needle guard (RNS) 24 during assembly so that the RNS is pulled off the syringe simultaneously when the cap 14 is removed. Therefore, the needle guard is also removed when the cap is removed.

[0097] refer to Figures 6A-6D In one embodiment, the housing 18 has a generally elongated tubular body that opens at both ends and has a generally elliptical cross-sectional profile of 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 a single piece. At the proximal end, the lower portion 134 includes a proximal opening 136 having a generally circular circumference and a generally cylindrical portion 137 configured to fit into the cap assembly. In some embodiments, the lower portion 134 has an outer diameter of approximately 20 mm at the proximal opening 136. The lower portion 134 has a shaped interface 144 at its distal end adjacent to the upper portion 135 to provide natural lead-out to the cap 14. The cylindrical portion 137 includes two pins 141 spaced apart from each other and configured to provide natural engagement with the retention hole 106 of the cap 14. The tubular body 133 of the housing 18 also includes a gripping feature 142, which is positioned continuous with the gripping feature 103 of the cap 14 to provide a smooth gripping portion for the autoinjector 12 before use.

[0098] The housing can have various shapes, including but not limited to cylindrical, circular, or rectangular. The housing can have a contour that allows for easy gripping of the device during use. In some embodiments, the housing can be tilted for right-handed and left-handed users, or can be ambidextrous.

[0099] To improve the visibility of the syringe and its contents, at least two spaced-apart windows 140 may be provided above the cylindrical portion 137 within the tubular body of the housing 18. The windows 140 are configured to allow visualization of materials, such as the syringe or container 30 and / or medication within it. In one embodiment, the windows 140 are configured with a first color, such as red when there is no syringe and / or medication within the housing 18, and a second color, such as green when there is a syringe and / or medication within the housing 18. The housing 18 also includes a gripping feature 142 that mates with a gripping feature 103 of the cap 14. The housing 18 also includes a shaped cap interface 144, which also mates with the cap 14 to provide natural draw and tension when the cap 14 is unscrewed. To provide positive retention of the skin sensor 32 and eliminate the possibility of removal after use, the housing 18 includes at least two (2) skin sensor slots 148. Below each window 140, the tubular body of the housing 18 includes an assembly hole 150 configured to securely hold the skin sensor 32 when the cap assembly is assembled during the automatic assembly of the autoinjector. In some embodiments, the overall length of the tubular body 133 of the housing 18 is approximately 90 mm.

[0100] Other components of the autoinjector included in housing 18 include skin sensor 32, which includes skin sensor insert 34, skin sensor spring 36, carriage 40, collar 16, restraint 38, carriage thrust bearing 41, plunger 42, plunger spring 44, housing top 20, and housing top insert 22, all of which interact with each other as described herein.

[0101] A skin sensor 32 is disposed within the housing 18. One end of the skin sensor 32 is configured to engage with tissue (e.g., skin) when the autoinjector 12 injects material (e.g., a drug) into or beneath the patient's skin. One embodiment of the skin sensor 32 is... Figures 7A-7D As shown in the image. (Reference) Figure 7A and 7B The skin sensor 32 includes a body 170 having a lower tubular portion 172 located proximally, an upper tubular portion 174 located distally, and an aperture 161 extending through the body 170. At the proximal end, the aperture 161 is bounded by a front face 171 of the lower tubular portion 172, wherein the front face 171 has a central aperture 173 configured to allow the needle 28 to move through once the autoinjector 12 is pressed against the injection site and the skin sensor retracts.

[0102] Compared to the distal upper tubular portion 174, the lower tubular portion 172 has a reduced diameter profile, adapted to allow the skin sensor insert 34 to incorporate a locking mechanism. In some embodiments, the lower portion 172 has a diameter of approximately 15 mm. Externally, the lower tubular portion 172 also includes at least two cap assembly holding points 164 spaced apart from each other, facilitating clamping 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 adjacent to the lower portion 172 and two arms 176 extending generally axially from the base 175 along a longitudinal axis DD and having opposing concave surfaces adapted to receive the skin sensor spring 36. The upper tubular portion 174 of the skin sensor 32 includes at least a clamping groove 160 configured to receive at least the external lug 196 of the skin sensor insert 34. In some embodiments, the upper tubular portion 174 has two clamping grooves 160 configured to receive the external lug 196 of the skin sensor insert 34. Each arm 176 includes an external lug 162 with a double dovetail portion that provides an upright position within the housing 18 to ensure functionality and eliminate the possibility of removing the skin sensor 32 after use. In some respects, the diameter of the upper tubular portion 174 of the skin sensor 32 is approximately 20 mm. In other respects, the overall length of the skin sensor 32 is approximately 57 mm.

[0103] The upper tubular portion 174 of the skin sensor 32 also includes a skin sensor cam or ramp 166, which in some respects can interact with the outer lug 62 of the collar 16 to overcome the initial threshold force generated by the interaction between the end face 171 of the skin sensor 32 and the user's skin. The upper tubular portion 174 of the skin sensor 32 also includes a component release feature 167 added to its skin sensor base 175, which provides positioning and clamping form during assembly of the skin sensor insert 34. Furthermore, the component release feature 167 can provide assembly assistance and lock the skin sensor insert 34 to the carriage 40, while the two components are secured together.

[0104] The skin sensor insert 34 is disposed within the skin sensor 32. Figures 8A-8D An embodiment of the skin sensor insert 34 is shown. (See reference...) Figures 8A-8DThe skin sensor insert 34 includes a tubular body 190 having a cylindrical, distally located upper body 192 defining an aperture 191 and abutting a proximal lower cylindrical skirt 194 having a base 188 and a face 193 extending generally radially outward from the upper body 192 and perpendicular to the base 188. In several embodiments, the upper body 192 has a diameter of about 14 mm. In some embodiments, the base 188 has a diameter of about 17 mm. The skirt 194 includes a pair of actuating wings or W-shaped cams 198 extending generally axially from the base 188 to provide means for the cap assembly to interact with the skin sensor insert 34 and to rotatably drive the pin 200 to a locked position. In some embodiments, externally, the upper body 192 includes a spring alignment boss 196, which reduces the risk of potential spring end jamming and compensates for an increase in the length of the skin sensor spring 36. An embodiment of the skin sensor spring is shown in Figure 16a. Internally, the upper body 192 also includes a pin 200 for achieving the desired locking function, allowing the inclined surface of the carriage to slide upwards 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 required for the locking mechanism.

[0105] The housing 18 also includes a carriage 40 and a collar 16 configured to be slidably positioned above the carriage 40. Figures 9A-9B An embodiment of the carriage 40 is shown in the figure.

[0106] The carriage 40 has a tubular body 210 along a longitudinal axis AA, the tubular body having a lower portion 212 and an upper portion 214 adjacent to the lower portion 212. In one aspect, the carriage 40 is a single piece 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 approximately 10 mm. Externally, the lower portion 212 includes at least one ramp ridge 228, and in some embodiments includes two ramp ridges 228 that are spaced apart from each other on opposite sides of the lower portion 212 and located at the distal end of the lower portion 212. The ramp ridges 228 have straight edges 229 and arcuate edges 230 that meet at point 231 and provide a carriage threshold surface 233 configured to receive a collar 16 such that the collar cooperating with the skin sensor 32 can partially rotate the carriage 40. The skin sensor 32 is pre-compressed on the spring 36, and this pre-compression force acts axially on the collar 16, which induces a rotational torque on the carriage 40 through the arcuate edge 230. In some embodiments, the arcuate edge 230 may be helical. In several aspects, the straight edge 229 may have a length of about 25 mm, while the arcuate edge 230 may have a length of about 30 mm.

[0107] In several embodiments, the lower portion 212 includes at least a stop rib or track 232, spaced-apart injection tracks or ribs 234, and an inverted J-shaped rib or locking track 236, all arranged around the proximal opening 211 of the carriage body 210 and including functions for needle insertion and stop, as well as injection functions available to an autoinjector. The stop rib or track 232 and the injection rib or track 234 are spaced apart but arranged adjacent to each other, with the stop rib being shorter than the injection rib. In several embodiments, the injection track 234 is adjacent to the straight edge 229 of the ramp ridge 228. In some aspects, the stop track 232 has a length of about 20 mm, and the injection track has a length of about 36 mm. The stop rib 232 is located between the inverted J-shaped rib or track 236 and the injection track 234. The inverted J-shaped rib 236 has a straight edge 238 and a U-shaped channel 237. In several aspects, the straight edge 238 of the inverted J-shaped track 236 has a length of about 16 mm. In other respects, all external tracks of carriage 40 have a thickness of approximately 1.5 mm. In some embodiments, the stop rib 232, injection rib 234, and inverted J-shaped rib or locking track 236 comprise a pair that are spaced apart from each other and face each other.

[0108] In other embodiments, the upper portion 214 includes a base 216 having a lower edge 218 and an upper edge 220, both edges configured to receive the carriage thrust bearing 41. In some embodiments, the upper portion 214 of the carriage 40 further includes two arms or lugs 226 extending from the upper edge 220 positioned around the distal opening 227, facing each other and forming a U-shape with the upper edge 220. In several embodiments, the outer diameter of the lower edge 218 is approximately 10 mm, and the outer diameter of the upper edge 20 is approximately 17 mm. In other embodiments, the length of the arms or lugs 226 is approximately 21 mm.

[0109] The collar 16 is connected to the skin sensor 32 at the proximal end and to the carriage 40 at the distal end. Figure 11A-11D An embodiment of the collar 16 is shown. In this embodiment, the collar 16 has a tubular body 50 with a hole 49 passing through it. The body 50 is defined by a ribbed wall having a proximal opening 51 and a distal opening 53, and is configured to slide on a carriage 40. Externally, the collar 16 includes ribs 54 and ridges 55, both of which can be used for ejector optimization and to provide sufficient wall thickness. In one embodiment, the length of the rib 54 is approximately 17 mm. At the distal end, the tubular body 50 has a collar threshold surface 64, which is configured to engage with the carriage threshold surface 233 under the load of the skin sensor spring 36. In one embodiment, Figure 10A and 10BThe image shows a carriage thrust bearing 41. The carriage thrust bearing 41 has a proximal surface or lower surface 43a, a distal surface or upper surface 43b, and four tabs 48. The surfaces 43a of the four tabs 48 contact the bottom of a slot in the housing 18, defining the axial position of the carriage thrust bearing 41 within the housing 18. The distal surface 43b contacts the bottom side of the upper edge 220 of the carriage 40. In some embodiments, the outer diameter of the carriage thrust bearing 41 is approximately 20 mm.

[0110] At its proximal end, the tubular body 50 of the collar 16 includes a spring-aligning boss 52. In several embodiments, the bosses 52 are spaced apart from each other around the proximal opening 51 and configured to eliminate potential end jamming of the skin sensor spring 36 coupled to the collar 16. The tubular body 50 of the collar 16 includes two spaced-apart windows 58 facing each other, each window being framed by a marked area 57 provided to the patient as an indicator when the autoinjector 12 is used. In some aspects, the length of the window 58 is about 17 mm, and the width is about 7 mm when the window 58 is rectangular. In several embodiments, the collar 16 is manufactured green to serve as a patient indicator of the status of the autoinjector. The tubular body 50 also includes an assembly feature 56 located at its proximal end below each window opening 58. In some embodiments, at the distal end of the tube 50, the collar 16 includes an external tab 62 movably disposed in a slot in the housing 18 to rotatably key the collar 16 to the housing 18.

[0111] The position of the syringe or container 30 is further controlled by the 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 transferring the needle injection load to the housing 18. Figure 12A-12B An embodiment of the restraint 38 is shown. In this embodiment, the restraint 38 includes a cylindrical body 250, a wing member 270 adjacent to the body 250 and extending along a longitudinal axis BB, and a bridging member 330 connecting the cylindrical body 250 to the wing member 270. In some embodiments, the cylindrical body 250 is supported by two bridging members 330 between two wing members 270.

[0112] The cylindrical body 250 is defined by a circumferential wall 251, a distal opening 252, and an opposing proximal opening 254. The restraint body 250 has a flat surface 256 at its proximal end that contacts the syringe or container 30, while the cylindrical body 250 has an edge 255 at its distal end.

[0113] In several embodiments, the restraint body 250 includes a syringe retaining clip 258 attached to an edge 255 within its circumferential wall 251. In some aspects, the outer diameter of the restraint body 250 is approximately 14 mm. Surrounding the retaining clip 258 is a generally rectangular cutout 260, which, together with the retaining clip 258, is configured to secure a syringe or container 30 suspended at the center of the carriage 40. In some aspects, the retaining clip 258 has a rectangular shape formed as a tapered or arcuate protrusion extending toward the inner surface of the restraint body 250. In some aspects, the cutout 260 forms a U-shape around the slightly concave retaining clip 258.

[0114] In several aspects, the restraint 38 includes wing members 270, which in some aspects are two wings 270 spaced apart from each other and connected to the restraint body 250 via bridging members 330. In some aspects, the wing members 270 have a rectangular body 272 including a first surface 274, a second surface 276, and a side surface 278 between the first and second surfaces. In other aspects, the length of the wing members 270 may be approximately 40 mm. The first surface 274 may include a feedback arm 300 and the bridging member 330. In other aspects, the second surface 276 may include a groove 280 and a ridge 282. The side surface 278 may also include a groove 288 and a ridge 289.

[0115] In several embodiments, the bridging member 330 divides the body 272 of the wing member 270 in two, thereby defining an upper wing portion 284 above the restraint body 250 and a lower wing portion 286 below the restraint body 250. In some aspects, the upper wing portion 284 is longer than the lower wing portion 286. In other aspects, the upper wing portion 284 may have a length of about 22 mm, while the lower wing portion 286 may have a length of about 17 mm. A groove 280a on the second surface 276 of the upper wing portion 284 is larger than a groove 280b on the second surface 276 of the lower wing portion 286. In some aspects, the wing member 270 includes at least two grooves.

[0116] In several respects, the bridging member 330 includes a rectangular arm 332 and a triangular support 334 disposed below and adjacent to the rectangular arm 332. The triangular support 334 has a triangular surface that can be lightly pressed and has more contact points with the wing member body 272 than with the restrainer body 250.

[0117] In some aspects, the 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 a first surface 274 of the upper wing portion 284 and a second end 309 having a distal end 310 slightly protruding above the elbow joint 306, the distal end 310 forming an L-shape with the lower arm 304, the lower arm being longer than the distal end 310. In other aspects, 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 aspects, the restraint 38 is a single piece. In several aspects, the upper arm 302 may have a length of approximately 6 mm, while the lower arm 304 may have a length of approximately 2 mm.

[0118] In several embodiments, the restraint 38 is configured to generate auditory and / or tactile feedback to indicate that the plunger 42 has been activated to push the drug into the syringe or container 30 when it contacts the elbow joint 306 of the feedback arm 300. In several embodiments, the container 30 does not move longitudinally relative to the housing 18.

[0119] The syringe 30 includes a stopper 31 movably positioned therein, for example, as shown in the image. Figure 3 As shown. Figure 17A and 17B An embodiment of a syringe or container 30 is shown. Figure 17B In one embodiment, the syringe or container 30 contains the drug 29. Figure 17C and 17D An embodiment of the stopper 31 is shown. In several embodiments, the stopper 31 is configured to engage with a plunger 42 to allow the stopper 31 to move within the syringe or container 30 to expel medication from the syringe or container 30. The syringe or container 30 also includes a needle 28. In several embodiments, depending on the injection site, the length of the needle 28 may vary from about 7 / 8 inch to about 1 inch and has a specification from about 25 to about 27 G, from about 7 / 8 inch to about 1 1 / 4 inch and has a specification from about 22 to about 25 G, and from about 1 inch to about 1 1 / 2 inch and has a specification from about 19 to about 25 G.

[0120] The plunger 42 extends through the restraint 38 and into the syringe or container 30 to move the plug 31 within the syringe or container 30 to expel a material such as a drug from the autoinjector 12. Figures 13A-13DAn embodiment of a plunger 42 is shown. 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 between them. The upper rod 400 is connected to the lower rod 500 at its proximal end. The upper rod 400 includes four (4) edges 402 that are perpendicular to each other and form a cross-section. The lower rod 500 is connected to the upper rod 400 at its distal end and to a plug 31 at its proximal end. The lower rod 500 includes four (4) edges 502 that are perpendicular to each other and form a cross-section. The lower rod 500 has a flat, circular base 506 at its proximal end for insertion into the plug 31. The lower rod 500 includes a protrusion 508 on one of the edges for orientation purposes at its distal end, located below the body 420. In several respects, the lower rod 500 has a larger diameter than the upper rod 400. In several respects, the upper rod 400 may have a length of about 25 mm, and the lower rod 500 may have a length of about 40 mm. In some respects, the flat, circular base 506 may have a diameter of approximately 5 mm.

[0121] The body 420 of the plunger 42 includes a lower cylindrical portion 422, an upper cylindrical portion 424, and an intermediate portion 440 located therebetween. The diameter of the lower cylindrical portion 422 is smaller than the diameter of the upper cylindrical portion 424 and is configured to engage with the restrainer 38. In some embodiments, the lower cylindrical portion 422 may have an outer diameter of about 8 mm, while the upper cylindrical portion 424 may have an outer diameter of about 10 mm. The upper cylindrical portion 424 includes a bayonet 450 with a semi-rectangular U-shape 452 at its distal end, configured to engage with the top of the housing 20. The upper cylindrical portion also includes a spring guide 454 at its distal end, and in some respects includes two spring guides spaced apart from and facing each other and configured to facilitate movement of the plunger spring 44. In some embodiments, the upper cylindrical portion 424 includes two bayonet 450s spaced apart from each other. The intermediate portion 440 includes lugs 430 and, in some respects, two lugs spaced apart from and facing each other, both configured to prevent the plunger 42 from firing until actuating the autoinjector 12. The body 420 of the plunger 46 also includes a bore 460 extending from the upper cylindrical portion 424 to the lower cylindrical portion 422 and configured to receive the plunger spring 44. In some embodiments, the plunger 42 is a single piece.

[0122] In several embodiments, the housing top 20 is connected to the housing 18 at its proximal end, and the housing top 20 is connected to the housing top insert 22 at its distal end. Figures 14A-14BAn embodiment of the housing top 20 is shown. The housing top 20 includes a generally elliptical tubular body 530 having a proximal opening 541, a distal opening 543, a proximal edge 536, a distal edge 538, and a wing 542. In several aspects, the body 530 may have an elliptical profile, wherein the major axis d1 of the elliptical profile is approximately 28 mm, and the minor axis d2 is approximately 25 mm. In other aspects, the length of the body 530 may be approximately 15 mm. The wing 542 is disposed at the proximal edge 536 of the tubular body 530, and the wing 542 has a retaining clip 544 configured to snap into 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-fit ​​portion 548 at the distal edge 549 of the retaining clip 544. Surrounding the retaining clip 544 is a generally rectangular cutout 550, which, together with the retaining clip 544 and the snap-fit ​​portion 548, constitutes a fixation to the housing 18. In some respects, the cutout 550 forms a U-shape around the retaining clip 544. In other respects, the tubular body 530 of the housing top 20 includes two wings 542 spaced apart from each other and facing each other. In many respects, the wings 542 may have a length of about 15 mm.

[0123] In several aspects, at the proximal edge of the tubular body 530, the housing top 20 includes a mechanism 552 for locking into the plunger 42. Mechanism 552 includes a platform 554, a frame 566 surrounding a notch 564, and alignment guides 560. The frame 566 abuts a tab 565 that projects inwardly to the tubular body 30 configured to securely hold the housing top insert 22. In some aspects, mechanism 552 includes four frames 566 surrounding four notches 564, each notch having a tab 565 and two alignment guides 560, all spaced apart from each other. The platform 554 includes a lower step 556 disposed near the wing 542, a latching surface 558 engaging with a latch 450 of the plunger 42, a longer toothed protrusion 561, and a shorter toothed protrusion 562, all configured to receive and secure the upper cylindrical portion 424 of the plunger body 420. In other embodiments, the tubular body 530 includes an alignment guide 560 disposed intermediately between the lower step 556 and the distal edge 538. In some aspects, the tubular body 530 includes two alignment guides 560 spaced apart from each other and facing each other. In several aspects, the housing top 20 is a single piece.

[0124] In many embodiments, the housing top 20 is coupled to the housing top insert 22. Figures 15A-15CAn embodiment of a housing top insert 22 is shown. The housing top insert 22 includes a convex, generally elliptical top 600 and a tubular body 602 attached to the elliptical top 600 at a distal end 612. In several aspects, the elliptical top 600 may have a generally elliptical profile, wherein the major axis d1 of the elliptical profile is approximately 28 mm and the minor axis d2 is approximately 25 mm. At the proximal end, the tubular body 602 has a proximal opening 614 configured to engage with the housing top 20. In several aspects, the tubular body 602 is defined by a wall 603 including a cutout 604 disposed proximal to the wall 603 and configured to receive a tab 565 of the housing top 20. In some embodiments, the height of the wall 603 is approximately 13 mm. The wall 603 also includes an assembly-compliant V-shaped slot 610 and a V-shaped orientation feature 606 having two ramps 607 at the proximal edge 615 of the tubular body 602. In several embodiments, wall 603 includes four cutouts 604, two slots 610, and two directional features 606. Internally, tubular body 602 includes alignment guides 624. The housing top insert 22 also includes a plunger spring trap 620, which is cylindrical and has U-shaped cutouts 622 spaced apart from each other. The spring trap 620 is centrally located at its distal end 626 (not shown) and attached to the convex top 600. In several aspects, the spring trap 620 may have an outer diameter of approximately 7 mm. The spring trap 620 is configured to receive the upper rod 400 of the plunger 42 and the plunger spring 44. In several embodiments, the housing top insert 22 is a single piece.

[0125] exist Figure 16B One embodiment shows a plunger spring 44. The plunger spring 44 is disposed in the top insert 22 of the housing. When the autoinjector 12 is used, the plunger spring 44 engages the plunger 42 to push the syringe plug 31 to expel material, such as a drug, from the syringe or container 30 of the autoinjector 12. In some embodiments, when extended, the plunger spring 44 may have a length of approximately 58 mm and an outer diameter of approximately 4 mm.

[0126] Skin sensor lock

[0127] Internally, the removable cap 14 has a cam 104 that drives the skin sensor insert (SSI) 34 around the interior of the skin sensor 32 when the cap 14 is assembled onto the autoinjector 12. As the SSI rotates, its internal lug or pin 200 engages below the inclined locking surface of a modified U-shaped slot or inverted J-shaped slot on the surface of the carriage 40. The SSI has an external lug or external retaining pin 202 that engages on a clamping slot 160 in the skin sensor 32. Thus, if the autoinjector is dropped or impacted while configured for storage, movement of the skin sensor 32 is prevented under inertial forces via the load path: skin sensor clamping 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. SSI34 returns to its unlocked position via the action of the skin sensor or the drive spring 36 and the inclined surface of the modified U-shaped slot or inverted J-shaped slot on the carriage 40.

[0128] Start the syringe at the injection site.

[0129] When the autoinjector 12 is pressed against the injection site, the skin sensor 32 retracts, initiating the operating sequence and allowing the needle 28 to extend. The movement of the autoinjector 12 relative to the skin sensor 32 is subject to a threshold force requiring the user to apply an initial high force of 23 N to begin operation, which can then be reduced to 9 N. This threshold force is generated by the interaction of the cam surface 171 with the skin sensor on the drive collar 16. The movement of the collar 16 is resisted by a pair of angled surfaces between the collar 16 and the carriage 40, which are held in contact by the skin sensor or the drive spring 36. In some embodiments, the angled surfaces are surface 64 of the collar 16 and surface 233 of the carriage 40.

[0130] Once the threshold is overcome, the internal mechanism of the autoinjector controls the initiation of injection relative to the depth of needle insertion. When the autoinjector 12 presses against the injection site, the skin sensor 32 compresses the skin sensor spring 36. This skin sensor spring acts on a collar 16, which applies torque to a component of the carriage 40 via a helical cam 228. The rotation of this helical cam is controlled by features inside the skin sensor 32, such as the skin sensor insert 34.

[0131] When the skin sensor 32 is fully pressed to achieve the target needle insertion depth, it releases the carriage 40 to rotate, thereby rotating the plunger 42. The plunger 42 is held in place by a bayonet feature 558 in the top 20 of the housing against the force of the injection spring or plunger spring 44, and as it rotates, it moves freely under the action of the plunger spring or injection spring 44, thus driving the stopper 31 in the syringe or container 30 to expel the dose. The syringe or container 30 is suspended at the center of the carriage 40 by a restraint 38, which transfers the needle insertion and injection load to the housing 18. The restraint 38 has two feedback arms 300 that are tapped by the plunger 42 as it passes, providing audible / tactile feedback to indicate that a dose has been delivered.

[0132] Remove the syringe from the injection site.

[0133] Once the injection is complete and time allows for dose diffusion, the user withdraws the autoinjector 12 from the injection site. As the autoinjector 12 is withdrawn, the needle 28 is pulled out, and the skin sensor 32 advances to cover it. As the needle 28 is released, the skin sensor 32 is locked in the advanced position (compared to its initial position) by further rotation of the carriage 40 under the torque generated by the skin sensor spring-coil-helical cam system, thus preventing any contact with the contaminated tip. This advanced position also prevents the cap 14 from being safely replaced. In this state, the stopper 31 and the red plunger 42 are visible in the autoinjector window, further indicating to the user that the autoinjector has been successfully used.

[0134] exist Figures 18A to 18C One embodiment illustrates the removal operation of the cap and rigid needle sheath. Figure 18A A syringe or container 30 is shown, which is enclosed in a flexible needle shield 26 surrounded by a rigid needle shield 24. Figure 18A Also shown is a cap assembly 13 including a removable cap 14 and a cap insert 15. When the autoinjector 12 is assembled as shown in FIG18b, the clip 128 of the cap insert 15 engages with the rigid needle guard 24. When the cap 14 is removed, the clip 128 of the cap insert 15 engages with the end of the flange 27 of the rigid needle guard 24 to remove it, as shown in FIG18c.

[0135] exist Figures 19A-19D One embodiment illustrates the skin sensor locking operation. Figure 19A The assembly of skin sensor 32 and cap 14 is shown to begin. During cap 14 assembly, cam 104 of cap 14 engages with cam 198 of skin sensor insert 34, causing them to rotate. Figure 19B This is a cross-sectional view showing the initial contact between the cap cam 104 and the skin sensor insertion cam 198. Figure 19CThe fully assembled cap and skin sensor, including its skin sensor insert, are shown. Figure 19D This is a cross-sectional view showing the cap cam 104 fully engaged with the skin sensor insertion cam 198. Figure 19D In the illustrated embodiment, the skin sensor insert 34 has been rotated such that its inner lug or point 200 now engages with the locking feature of the carriage 40. Upon removal of the cap 14, the skin sensor spring 36 drives the skin sensor insert 34 downwards along the inclined surface of the inverted J-rib or track 236 of the carriage 40 and disengages it from the carriage locking feature. Figure 16A One embodiment shows a skin sensor spring 36. In some aspects, when extended, the skin sensor spring 36 may have a length of about 75 mm and an outer diameter of about 17 mm.

[0136] Figures 20A-20E An embodiment of the skin sensor assembly operation is illustrated. Before the assembly operation begins, the external retaining pin 202 of the skin sensor insert needs to be engaged into the tilted skin sensor clamping slot 160 in the skin sensor 32. As a result, the skin sensor insert 34 will be constrained before this operation begins. Figure 20A The image shows a skin sensor insert 34 before the skin sensor insert pin 200 has moved into the inverted J-shaped rib of the carriage 40. Figure 20B and 20C In this configuration, when the skin sensor is pushed, the skin sensor insertion pin 200 rubs along the cam surface 166 in the skin sensor, causing the skin sensor insert to rotate and engage the inner lug 200 into the carriage locking feature. Figure 20D and 20E In this process, the skin sensor insertion pin 200 moves into the U-shaped inclined channel or slot 237 of the inverted J-shaped track. This is accomplished by continuing to press the skin sensor 32 onto the sub-assembly, driving the skin sensor insertion pin 200 into the U-shaped slot 237.

[0137] Figures 21A-21E An embodiment of the actuation threshold is shown, illustrating the interaction between the skin sensor 32, the collar 16, and the slide 40. Figure 21A The skin sensor 32 is shown in a ready-to-use state, the collar slot 148 in the housing 18 and the carriage 40. Figure 21B The initial movement of the skin sensor 32 is shown. Figure 21C Further movement of the skin sensor 32 is shown, wherein the skin sensor cam 166 drives the collar 16 to rotate, thereby causing the collar threshold surface 64 to slide across the carriage threshold surface 233, thus generating a threshold reaction force. Figure 21DIn one embodiment, at the release point of the threshold surface between the collar threshold surface 64 and the carriage point 231, the collar 16 has been rotated such that the threshold surfaces are located at the carriage point 231 and the collar point 63, which have slid past each other. Figure 21E In this embodiment, after the threshold, during the needle insertion phase, the collar 16 has moved onto the main helical cam 228 of the carriage 40. The force from the skin sensor or drive spring 36 on the collar 16 generates torque on the carriage 40. In this embodiment, the skin sensor 32 has been removed from the collar drive cam 66, and the collar 16 now abuts against its working surface 68 in the housing 18.

[0138] exist Figure 22 In this embodiment, 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 a collar 16. Rotation of the carriage 40 can be prevented by a stop rib or track 232 that contacts the skin sensor insertion pin 200. In this embodiment, the skin sensor insertion pin 200 is shown at its insertion limit before transitioning to the injection phase. At this phase, if the user aborts the insertion of the autoinjector and withdraws the needle 28 before transitioning to the injection phase, the skin sensor 32 will advance but not lock. In subsequent attempts, the autoinjector will operate, but without the threshold force required to actuate it.

[0139] exist Figure 23A and 23B In the illustrated embodiment, the autoinjector 12 is shown at the transition point to the start of the injection phase. Figure 23A In the middle, the force of the drive or skin sensor spring 36 (not shown) applies torque to the carriage 40. The skin sensor insertion lug 200 passes over the top of the stop rib 232 onto the injection rib or track 234, thereby allowing the carriage 40 to rotate. Figure 23B In the middle, the carriage lug or arm 226 begins to rotate the plunger 42. The plunger 42 is held in the top 20 of the housing by its bayonet feature 450.

[0140] exist Figure 24A and 24B In the illustrated embodiment, the rotation of the carriage 40 has pushed the plunger 42 away from the holder of its bayonet 450, and the plunger driver 42 is free to advance the plunger 31 under the action of the plunger spring 44 (not shown).

[0141] Figures 25A to 25D The illustrated embodiment demonstrates the interaction between the collar, carriage, and skin sensor insert during the locking phase after needle withdrawal. Figure 25A Meanwhile, collar 16 continues to apply torque to carriage 40. Figure 25B In the middle, the skin sensor is inserted into the lug 200 to reduce or prevent the carriage 40 from rotating against the carriage injection rib or the track 234. Figure 25C and 25D The illustration shows the situation when the needle 28 (not shown) is fully withdrawn so that the skin sensor insertion lug 200 falls from the end of the injection rib 234 and enters the locking feature.

[0142] The operation of the delivery device 10 (in some respects, the auto-injector 12) is also schematically shown in Figure 26-36 As shown in [the image]. Figure 26 In the illustrated embodiment, the autoinjector 12 is stationary. Before engagement of the cap cam 104 and the W-shaped cam 198 of the skin sensor insert 34, the parallelogram-shaped lug 200 of the skin sensor insert 34 is positioned at the bottom of the U-shaped slot 237 in the inverted J-shaped rib 236 of the carriage 40 under a downward load from the skin sensor spring 36 (not shown). The upper end of the skin sensor spring 36 acts on the collar 16, maintaining threshold feature engagement. The skin sensor spring 36 (not shown) acts upward on the collar 16 and downward on the skin sensor insert 34.

[0143] exist Figure 27 In this embodiment, the autoinjector 12 remains stationary in its stored state. The lug 200 of the skin sensor insert 34 is pushed to the right by the cap cam 104, thereby engaging the skin sensor insert lug 200 into the locking feature of the carriage 40. The carriage 40 cannot rotate because the collar 16 engages at the bottom of the carriage cam 228 (not shown). 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 in place by the housing top 20.

[0144] exist Figure 28 In the middle, removing the cap will release the skin sensor insert 34, which is pushed out of the locking feature of the slide 40 by the angled ramp of the skin sensor spring 36 and the locking feature of the slide 40 (same as the state before final assembly).

[0145] Figure 29 The embodiment illustrates the first movement of the skin sensor 32. The threshold force mechanism is overcome. The lug 200 of the skin sensor insert 34 exits the U-shaped slot 237 of the carriage 40. The collar 18 can now apply torque to the carriage 40, but the carriage has not yet moved.

[0146] Figure 30The needle insertion stage is shown. In this stage, the collar 16 moves upward under the load of the skin sensor spring 36 and has already rotatably driven the carriage 40. The carriage 40 stops rotating when the stop rail 232 contacts the skin sensor insertion lug 200. The carriage top lug or arm 226 has rotated to the plunger lug 430 (not shown). Further needle insertion compresses the skin sensor spring 36.

[0147] Figure 31 The embodiment illustrates an aborted 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 at the same rate as the withdrawal of the autoinjector 12. The skin sensor is not locked, allowing for a second insertion attempt. In some respects, this state may or may not occur and is not part of the normal sequence of use. The skin sensor 32 may extend further from the body of the autoinjector 12 compared to the initial position.

[0148] Figure 32 The embodiment illustrates the transition of the autoinjector 12 to the injection phase. The skin sensor insertion lug 200 is high enough to disengage from the stop track 232 and is about to allow the carriage 40 to rotate. At the last point before the carriage is released from rotation, the maximum internal spring compression is reached, and the autoinjector 12 is in a momentary state.

[0149] Figure 33 The operation of the autoinjector 12 during the injection phase is illustrated. To initiate injection, the plunger 42 is released. The needle 28 is fully inserted, and the skin sensor insertion lug 200 clears the stop track or rib 232. The collar 16 freely drives the carriage 40 to rotate again and actuate it until it is fully inserted or the injection rib 234 contacts the skin sensor insertion lug 200. This rotation of the carriage also releases the plunger 42 from the top of the housing 20 for injection (the plunger 42 is shown in an immediate state about to begin its stroke).

[0150] Figure 34 The illustrated embodiment shows the completed injection phase. In this phase, the stopper 31 reaches its end stop. The injection or plunger spring 44 drives the plunger 42, and thus the plunger injects the dose. In some embodiments, if the autoinjector 12 is configured to be completely emptied, the injection end stop occurs where the stopper 31 touches the bottom of the syringe or container 30. In other embodiments, if the autoinjector 12 is configured to be partially emptied, the injection end stop occurs when the plunger 42 stops on the restraint.

[0151] exist Figure 35In this embodiment, the skin sensor 32 is extended. For example, when the user withdraws the needle from their leg, the skin sensor spring 36 pushes the skin sensor 32 out. The slip ring 18 cannot move because the carriage 40 cannot rotate, as its movement is reduced or prevented by the skin sensor insertion lug 200 against the insertion or injection rib 234.

[0152] Figure 36 The locked skin sensor 32 is shown. The skin sensor insertion lug 200 disengages from the fully inserted or injection track 234, causing the carriage 40 to rotate finally. The collar 18 drives the carriage 40 by its final rotation. The autoinjector 12 is now locked so that pushing the skin sensor 32 will not move it.

[0153] Figures 37A-37E The embodiments illustrate the entire cycle of the injection phase using the delivery device 10 described in this application. In some embodiments, the delivery device 10 may be an autoinjector 12. Figure 37A An autoinjector 12 in its initial storage state is shown. Figure 37B An autoinjector 12 is shown with its cap removed and positioned against an injection site 700, such as the skin surface. Figure 37C The automatic injector 12 is shown when the safety system is activated, the needle is inserted into the injection site 700, and the plunger 42 (not shown) is released. Figure 37D In the middle, the plunger 42 moves downward to connect with the stopper 31 and delivers a dose of drug from the container or syringe 30 through the needle 28. Figure 37E The autoinjector is shown after the skin sensor 32 returns to its starting position to shield the needle 28.

[0154] Device components (e.g., needles, caps, medications, etc.) can be sterilized. In several embodiments, one or more components of the device for injecting medication can be sterilized by radiation during a final sterilization step in the final packaging. Final sterilization of the product provides greater assurance of sterility compared to processes such as aseptic processes, which require sterilization of individual product components and assembly of the final package in a sterile environment. In some embodiments, one or more components of the device can be aseptically assembled.

[0155] In several embodiments, gamma radiation can be used in the terminal sterilization step, which involves utilizing the ionizing energy from gamma rays to penetrate deeply into the device. Gamma rays are highly effective at killing microorganisms, leaving no residue, and do not have sufficient energy to impart radioactivity to the device. Gamma rays can be used when the device is in packaging and gamma sterilization does not require high pressure or vacuum conditions, thus avoiding stress on packaging seals and other components. Furthermore, gamma radiation eliminates the need for permeable packaging materials.

[0156] In several embodiments, electron beam (e-beam) radiation can be used to sterilize one or more components of the device. Electron beam radiation includes forms of ionizing energy and is typically characterized by low penetration and high dose rates. Electron beam radiation is similar to gamma-ray treatment because it alters various chemical and molecular bonds upon contact, including those affecting the reproductive cells of microorganisms. The beam generated for electron beam sterilization is a concentrated, highly charged stream of electrons produced through electrical acceleration and conversion. For example, electron beam sterilization can be used when a drug is contained in a gel form.

[0157] Other methods may also be used to sterilize one or more components of a drug and / or device, including but not limited to gas sterilization, such as sterilization with ethylene oxide or steam.

[0158] One or more components of the device may be made of materials such as polyurethane, polyurea, polyether (amide), PEBA, thermoplastic elastomers, olefins, copolyesters and styrene-based thermoplastic elastomers, steel, aluminum, stainless steel, titanium, nickel-titanium, metal alloys with high non-ferrous metal content and low iron content, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.

[0159] It will be apparent to those skilled in the art that various modifications and variations can be made to the various embodiments described herein without departing from the spirit or scope of the teachings herein. Therefore, it is intended that the various embodiments cover other modifications and variations of the various embodiments within the scope of these teachings.

Claims

1. A removable cap for a device for injecting drugs, the cap comprising: A tubular body having a generally 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, and the distal end being configured as a housing for receiving a device. The cap insert includes a cap, a cap insert body, and a capture member for attaching a needle guard to a container, wherein... The cap also includes a locking lug or cam for providing a locking mechanism for the device, wherein the device includes a skin sensor insert configured to initiate injection, the skin sensor insert including a locking surface configured to lock with a locking surface of the cap before the cap is removed, the locking surface of the skin sensor insert including a W-shaped cam, and the locking surface of the cap including a triangular cam configured to engage with the W-shaped cam of the skin sensor insert to prevent the device from injecting medication without first removing the cap.

2. The removable cap according to claim 1, wherein, The cap also includes a gripping feature at the distal end of the tubular body and a locking lug or cam for providing a locking mechanism for the device.

3. The removable cap according to claim 1, wherein, The cap includes a recess for holding the housing of the device.

4. The removable cap according to claim 1, wherein, The cap insert includes a cap, a cap insert body, and a capture member for attaching a needle to a needle in the container.

5. The removable cap according to claim 4, wherein, The capturing member is a tubular shaft centrally disposed on the cap along a longitudinal axis, the tubular shaft also including a clamping hook configured to engage the needle shroud.

6. The removable cap according to claim 4, wherein, The cap insert includes two arms having opposing concave surfaces and arranged around a capture member of the cap insert configured to engage with the proximal end of the cap.

7. An apparatus for dispensing a drug, the apparatus comprising: A housing having a proximal end, the housing having a container disposed within the housing, the container being configured to contain a drug, 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, and the distal end of the plunger being configured to engage a first resilient member and move the stopper within a container to dispense medication from the container away from the needle. A carriage having at least a portion of a container disposed therein, the carriage 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 and cause rotation of the carriage, and the proximal end of the collar being configured to engage with 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, and the proximal end of the skin sensor being configured to contact the skin; as well as A cap, configured to engage the proximal end of the housing and a skin sensor, the cap having a locking surface configured to lock with a locking surface of the skin sensor to reduce movement of the skin sensor. The proximal end of the tubular body of the cap is configured to receive a cap insert for covering the tubular body of the cap. The cap insert includes a cap, a cap insert body, and a capture member for attaching a needle guard to a needle in the container. The cap further includes a locking lug or cam for providing a locking mechanism for the device. The skin sensor includes a skin sensor insert configured to initiate injection. The skin sensor insert includes a locking surface configured to lock with the locking surface of the cap before the cap is removed. The locking surface of the skin sensor insert includes a W-shaped cam, and the locking surface of the cap includes a triangular cam configured to engage with the W-shaped cam of the skin sensor insert to prevent the device from injecting medication without first removing the cap.

8. The apparatus according to claim 7, wherein, The skin sensor insert includes a lug configured to engage a U-shaped slot in the carriage and / or a slot in the skin sensor.

9. The apparatus according to claim 7, wherein, The concave or protruding portion of the cap includes a triangular cam.

10. The apparatus according to claim 8, wherein, The carriage has a proximal end and a distal end, the proximal end being configured to engage with a lug of the skin sensor insert, and the distal end being configured to engage with the collar.

11. The apparatus according to claim 8, wherein, The carriage includes a tubular body having a proximal end and a distal end, a lower portion at the proximal end of the tubular body, an upper portion at the distal end of the tubular body, and a base between the upper and lower portions of the tubular body.

12. The apparatus according to claim 11, wherein, The proximal end of the carriage also includes a stop rail, an injection rail, and a locking rail, which are spaced apart from each other and adjacent to each other.

13. The apparatus according to claim 10, wherein, The lower part of the tubular body of the carriage also includes a stop rail, an injection rail, and a locking rail, which are located at the proximal end of the lower part of the tubular body of the carriage, spaced apart from each other and adjacent to each other.

14. The apparatus according to claim 12, wherein, The locking track is positioned between the stop track and the injection track.

15. The apparatus according to claim 14, wherein, The locking track includes a U-shaped slot configured to engage a lug of the skin sensor insert to reduce or prevent movement of the skin sensor in the event of a drop or impact.

16. The apparatus according to claim 15, wherein, When the cap is removed from the housing and an injection force is applied to the skin sensor, the second elastic member is compressed and drives the needle protector insert down the ramp of the U-shaped slot and disengages from the locking track.

17. The apparatus according to claim 11, wherein, The skin sensor insert also includes an external pin, and the skin sensor includes an external slot and a cam surface configured to allow the external pin of the skin sensor insert to extend along the cam surface of the skin sensor and engage with the slot of the skin sensor.

18. The apparatus according to claim 8, wherein, The distal end of the skin sensor also includes a cam for engaging with the collar.

19. The apparatus according to claim 18, wherein, The collar also includes a threshold surface at its distal end, and the cam of the skin sensor rotates the threshold surface of the collar and engages with the slide to generate a threshold force.

20. The apparatus according to claim 19, wherein, The threshold force varies from 9N to 23N.

21. The apparatus according to claim 10, wherein, The carriage also includes a helical cam at its distal end, the helical cam having a straight edge and an arcuate edge, the edges defining a point configured to receive the collar so that the collar can rotate the carriage.

22. The apparatus according to claim 21, wherein, The second elastic member is a spring, which applies torque to the carriage when compressed, thereby causing the carriage to rotate.

23. The apparatus according to claim 7, wherein, The drugs include analgesics, anti-inflammatory agents, hormones, beta agonists, alpha agonists, beta antagonists, alpha antagonists, benzodiazepines, glucose regulators, anesthetics, anesthetic antagonists, cholinergics, anticholinergics, muscarinic agonists, muscarinic antagonists, steroids, chloride salts, iodide salts, cholinesterase reactivators, cholinesterase agonists, antibacterial agents, antiarrhythmic agents, vasodilators, vasoconstrictors, anticoagulants, cardiovascular agents, anti-Parkinson's agents, antipsychotics, immunosuppressants, antihistamines, or combinations thereof.

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