Compact autoinjector

Abstract

A compact autoinjector includes a sealed housing rotatably retained in a cap. Once the autoinjector is positioned at the injection position, the user may transition the housing from the locked position to the standby position. The user may then compress the sealing housing into the cap, thereby triggering an activation mechanism that initiates the injection. The first activation mechanism is engaged with the interlocking device to prevent the auto-injector from being reused. A second activation mechanism straightens and extends the curved needle to set the length of the exposed needle. A third activation mechanism pierces the sealed reservoir, allowing the medication to be forced through the injection needle. After injection, the autoinjector extends and interlocks, retracting the needle into the autoinjector and preventing reuse.

Description

[0001] This application is a divisional application of the Chinese invention patent application No. 201880065137.1, which has entered the Chinese national phase of the international application PCT / US2018 / 048878 with the invention name “Compact Automatic Injector” and the international application date of August 30, 2018.

[0002] Cross-application of related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 552,052, filed on August 30, 2017, entitled “Compact Auto-Injector,” and U.S. Provisional Patent Application No. 62 / 568,567, filed on October 5, 2017, entitled “Protective Case for an Auto-Injector,” the contents of which are incorporated herein by reference in their entirety. Technical Field

[0004] The present invention relates generally to medication autoinjectors, and more particularly to an autoinjector having a relatively low profile and a high aspect ratio. The autoinjector allows for intramuscular or subcutaneous administration of a desired dose of medication. Background Art

[0005] The autoinjector market is growing rapidly due to increased prescriptions as well as new indications for use. Autoinjectors are becoming increasingly dominant as they offer an innovative way to administer drugs or biologics and can improve safety, improve dosing accuracy, and increase patient compliance, especially in the self-administration setting.

[0006] Existing auto-injectors cause patients to actively seek alternatives to address the anxiety they feel associated with existing pain points; poor portability, lack of concentration, accidental injections, and lacerations. An improved auto-injector is needed. Summary of the invention

[0007] Through a human-centered design focus, embodiments of the auto-injectors described herein are portable, intuitive, and easy to use. Auto-injector technology can be widely used for a variety of indications requiring a fixed dose, one-time intramuscular or subcutaneous injection. Embodiments of the auto-injector are designed to take human factors into account. The enhanced ergonomics of embodiments of the device combined with high aspect ratio injector technology are designed to match modern lifestyles. Embodiments of the present invention include high aspect ratio auto-injector technology that enables the creation of a portable, wearable auto-injector for safe and effective dosing of epinephrine and other medications (note, Fig.141The exemplary numerical ranges in the chart of relate to the delivery of a variety of drugs, but can be adjusted as needed to accommodate the delivery of other drugs). Figure 1 An example illustration of how to calculate the aspect ratio of an auto-injector using both a conventional auto-injector and the auto-injector of the present invention described herein is provided. Figure 1 As shown, the height (H) is defined as the maximum straight-line length of the autoinjector away from the skin during injection (perpendicular to the injection surface), while the width (W) is defined as the minimum straight-line length of the surface in contact with the patient's skin during injection (parallel to the injection surface).

[0008] The novel auto-injector technology can be easily incorporated into an auto-injector that can be worn in a bracelet, pendant, or other accessory to ensure that the auto-injector is always within reach in an emergency. The purpose of a safe, easy-to-use, portable wearable auto-injector, as well as other purposes, will be apparent to those skilled in the art.

[0009] In one aspect, the present invention is a compact automatic injector for delivering a dose of a drug subcutaneously or intramuscularly. The automatic injector may consist of two main components: a sealed housing and a cap. Arranged within the sealed housing is a drug reservoir containing the drug, a drug dispensing system (MDS), and a needle extension system (NES). During injection, the drug reservoir and the needle extension system are fluidly connected.

[0010] The sealing housing can be rotatably retained in the cover. In one embodiment, after the user inputs through the design interface, the sealing housing can be rotated from the initial position to the second position relative to the cover. At least one of the components including the sealing housing or the cover can include a mark indicating the first, second or subsequent position. The sealing housing can be constrained during conversion so that the sealing housing can be displaced relative to the cover in a controlled manner. The automatic injector may further include a biasing member, the function of which includes displacing the sealing housing relative to the cover. In various embodiments, the biasing member can be a spring, which is integrally formed with the sealing housing or the cover, or conversely, the spring is a separate component that can be arranged between the sealing housing and the cover. The automatic injector may further include an interlocking device so that the sealing housing cannot be displaced unless the user has removed or released the mechanism when the automatic injector is needed.

[0011] To assist the user in performing appropriate dosing, the auto-injector should be correctly oriented when injecting. The auto-injector can assist with orientation through labels, tactile surfaces, material color or transparency, and other markings indicating the selected side. In addition, the auto-injector can provide itself with a rotation aid, which can be contoured, textured, coated, or a combination thereof to further indicate orientation and operation. In addition, the auto-injector can include an observation window to view the interior of the auto-injector for drug inspection, which can further assist the user in establishing orientation.

[0012] In one aspect, the sealed housing is composed of two parts: a top half and a bottom half, which are matched together. Disposed in the sealed housing is a drug reservoir containing drugs, a drug dispensing system (MDS) and a needle extension system (NES). An embodiment of the bottom half can provide a hole for the injection needle to pass through. The geometry of the two half bodies makes it possible to position and fix the internal components. The two half bodies constituting the sealed housing can provide a mechanism or interface for rotating the housing relative to the cover. In some embodiments, the sealed housing can help determine the fixed position for the drug dispensing system and the needle extension system, and help release the two systems during injection. In addition, the housing can provide a feature for determining the angular displacement or rotation of the syringe to which the injection needle is fixed. The sealed housing can help provide alignment during displacement relative to the cover. In addition, both of the half bodies can provide a feature to assist the assembly of the two half bodies to ensure correct internal alignment. The sealed housing can provide a device for supporting or supporting the injection needle. In addition, once the injection has been performed, the two half bodies can receive or align interlocking devices to prevent the sealed housing from being displaced relative to the cover.

[0013] The drug dispensing system (MDS) for dispensing drugs is composed of a plunger, a biasing member, a retainer and a retainer. The biasing member can be similar to a mechanical compression spring. The spring can be kept in a state of potential energy to be released during injection. The retainer that displaces the plunger can constrain the spring at one end and have a fixed point at the other end. The retainer can promote self-fixation or be fixed in place using a separate locking mechanism that can be released or unlocked during injection. The retainer can constrain the side of the spring opposite to the retainer and control the displacement of the retainer relative to the retainer. The displacement of the retainer relative to the retainer is proportional to the volume of the drug distributed. The drug dispensing system can further include a dispensing needle, which is connected to the retainer and maintains constant fluid communication with the injection needle. Once the retainer contacts the plunger, the dispensing needle pierces the plunger and communicates with the contained drug, so the drug is also in fluid communication with the injection needle. Once the retainer is released, the retainer further displaces the plunger to pump the dose out of the reservoir through the dispensing needle, through the fluid connector, and through the injection needle. Flexible tubing or a combination of rigid and flexible tubing may be used to interconnect the dispensing needle and the injection needle.

[0014] In some embodiments, a needle extension system (NES) may include a curved injection needle, a syringe for supporting the curved injection needle, a syringe guide for aligning the syringe and the injection needle during administration, and a biasing member, the biasing member being coupled to the syringe for rotating the syringe to straighten the curved injection needle so as to deploy the distal end into the tissue. The biasing member may be a torsion spring. In some embodiments, the rotation axis of the syringe may be substantially perpendicular to the longitudinal axis of the drug reservoir. The needle extension system may include a syringe cap or another device for retaining or fixing the proximal end of the injection needle to the syringe. In addition, the syringe cap may help fix the flexible tube to the needle. The syringe cap and / or the syringe may provide a device for determining the starting rotation position and the ending rotation position of the injection needle in proportion to the injection depth. In some embodiments, the syringe may be fixed with a locking mechanism to maintain the potential energy of the torsion spring while remaining under load so as to be released or removed during injection. In addition, the syringe guide may maintain the concentricity of the syringe during injection. The step of triggering the deployment of the curved injection needle through the hole in the housing may comprise: manually compressing the autoinjector when the housing is aligned with the cover for injection, and rotating the syringe to drive the distal end of the curved injection needle through the hole. Advantageously, the step of retracting the distal end of the injection needle through the hole is caused by releasing the manual compression of the autoinjector. After injection, displacement of the sealing housing relative to the cover may actuate the interlock device, thereby preventing further reuse of the autoinjector.

[0015] In some embodiments, the housing is protected by a cover that provides protection for the sealed housing during storage of the automatic injector. The cover can also provide a device that constrains the sealed housing so that the sealed housing is displaced relative to the cover in a controlled manner. In various embodiments, the biasing member promotes this displacement of the housing relative to the cover. The biasing member can be a spring that is integrally formed with the cover or the sealed housing, or conversely, the spring is a separate component that can be arranged between the sealed housing and the cover. The cover can act as or serve as a trigger mechanism for injection. In addition to acting as or serving as a protection and trigger mechanism, the cover can also provide a stable base or platform to perform injection. The injection contact surface of the cover can provide a tactile surface that can promote the following functions: providing a stable base for the automatic injector during injection; helping the user to establish orientation; and fixing the automatic injector to the injection position by an adhesive layer or other attachment means. In addition, the constraint of the sealed housing by the cover can also be used as an alignment means during injection. Once the sealed housing has been moved relative to the cover to perform the injection, the cover will be manually compressed from the standby position to the injection position to release the drug dispensing system and the needle extension system to keep the alignment. Manual compression of the seal housing while performing an injection reduces the overall height of the auto-injector and brings the seal housing into contact with the intended trigger or protrusion on the cover. When performing an injection, the contact of the trigger or protrusion between the cover and the seal housing caused by the user's compression of the auto-injector may release the energy stored in the biasing member, thereby deploying the injection needle and dispensing the drug. When the seal housing is compressed relative to the cover, the distal end of the injection needle will protrude through the cover through the hole and dispense the desired dose. In some embodiments, the cover can be used as a device to straighten the injection needle and provide a support member to support the injection needle during injection. In this way, the section of the injection needle deployed into the tissue can be straight and perpendicular to the injection surface. In addition, the cover can provide a device to guide the seal housing during manual compression to facilitate alignment between the two components, thereby ensuring the correct release of the drug dispensing system and the needle extension system. When the applied compressive force is released, the biasing member displaces the seal housing relative to the cover, thereby increasing the height of the auto-injector and retracting the distal end of the injection needle to hide the needle and protect the user from accidental needle sticks. Advantageously, the auto-injector can include an interlocking device to prevent subsequent manual compression of the auto-injector, thereby making the auto-injector single-use. The interlocking means may be abutment structures in the housing and the cover. The method comprises the steps of triggering a bent injection needle to be deployed through a hole in the housing; straightening the injection needle to embed the distal end of the injection needle into the tissue at a desired depth; triggering a dispensing needle to pierce the drug reservoir to provide fluid communication between the reservoir and the injection needle; dispensing a dose through the injection needle; and then retracting the distal end of the injection needle.

[0016] In certain embodiments, a safety mechanism will be provided to the auto-injector to be removed first before any subsequent operation. Once the safety mechanism has been removed, the injection surface may be exposed to the user, further assisting in establishing the orientation of the auto-injector. The safety mechanism may also provide a device to prevent the seal housing from shifting relative to the cover before removal, so that the injection procedure may not be started without first removing the safety mechanism. Alternatively or additionally, the safety mechanism may protect the user from the injection needle if the injection needle is accidentally discharged or a protective cover or sheath performing a similar function is removed. Thus, removal of the safety mechanism may provide or facilitate the following functions: establishing the orientation of the auto-injector; providing an interlocking device to prevent the seal housing from shifting relative to the cover before removal; protecting the user from the injection needle; removing a combined or coupled component that will further protect the injection needle or protect the user from the injection needle; and a tactile coating or surface on the injection contact surface of the protective cover.

[0017] Before performing an injection, the injection needle in the needle extension system and the distribution needle in the drug dispensing system can be covered or sealed to maintain a predetermined cleaning standard during storage of the automatic injector. Therefore, one embodiment of the automatic injector can provide the user with protection from the distal end of the injection needle by means of a needle shield. The needle shield can completely enclose the injection needle to prevent any contamination of the needle before use. In one embodiment, the needle shield is used in combination with another component to protect the distal part of the injection needle to be embedded in the tissue from contamination. The needle shield can also provide a device to prevent the needle from injuring the user when an accidental discharge occurs. In other embodiments, the needle shield can be fixed to a safety mechanism to help prevent accidental injection. The needle shield can provide a fixing device to help remove before use. In one embodiment, the needle shield has a snap-fit ​​portion that allows the needle shield to be connected to the safety mechanism to assist in removal before injection. Alternatively, the needle shield can be used only to prevent the injection needle from being contaminated, and the safety mechanism can provide protection for the user to avoid accidental discharge of the injection needle.

[0018] In some embodiments, the auto-injector may have an internal power source to allow certain functions of the auto-injector to be implemented during storage, during injection, and after injection. The auto-injector may provide auditory instructions for performing the injection. In addition, the connection of the auto-injector to everyday smart devices allows other functions to be performed. The connected smart device can display visual and / or auditory instructions for performing the injection. Certain embodiments may allow the user to monitor the temperature and location of the auto-injector. In addition, the connected smart device may allow the user to see if there are other auto-injectors nearby. Once the injection has been initiated, additional embodiments may allow the smart device to contact emergency responders or next of kin. In addition, information about the auto-injector can be remotely monitored by the manufacturer.

[0019] In one aspect, the present invention relates to a compact high aspect ratio autoinjector for delivering a dose of a drug subcutaneously or intramuscularly. The autoinjector may include: a housing; a drug dispensing system disposed within the housing and including a drug reservoir adapted to contain the dose; and a needle extension mechanism coupled to the drug reservoir, the needle extension mechanism including a curved injection needle adapted to be straightened during needle deployment to facilitate dispensing of the dose by the autoinjector.

[0020] In some embodiments of the above aspects, the housing includes a sealed housing rotatably retained in the cover. The housing may also include an interface for receiving user input to facilitate manual rotation of the housing from a first locked position to a second unlocked position relative to the cover. In some cases, the housing, cover, label and / or a component directly visible to the user include markings indicating a locked position, an unlocked position and a standby position. The automatic injector may also include a biasing member so that when the housing is rotated to the unlocked position, the sealed housing is automatically axially displaced relative to the cover, thereby increasing the height of the automatic injector. The biasing member may include a spring that is integrally formed with the housing, integrally formed with the cover, and disposed between the housing and the cover. In some cases, the automatic injector also includes an interlocking device so that the housing cannot be rotated relative to the cover or cannot be axially displaced relative to the cover without removing the interlocking device. In some cases, manually compressing the automatic injector in the standby position reduces the height of the automatic injector and activates a mechanism that straightens the distal end of the injection needle and extends it through the housing, distributes the dose through the injection needle, and activates the interlocking device. In this case, upon release of manual compression, the biasing member may automatically displace the housing axially relative to the cover, thereby increasing the height of the autoinjector and retracting the distal end of the injection needle into the housing. The autoinjector may also include an interlock to prevent subsequent manual compression of the autoinjector, thereby making the autoinjector single-use. The interlock may include abutment structures in the housing and the cover.

[0021] In some embodiments of the above aspects, the drug dispensing system may further include a plunger, which is located in the drug reservoir and forms a sealed cavity for holding a dose. The drug dispensing system may include a distribution needle that is in fluid communication with the injection needle. In some cases, the automatic syringe may include a flexible tube that interconnects the distribution needle with the injection needle. The drug dispensing system may also include a spring, a retainer, and a locking mechanism so that when the locking mechanism is released, the spring displaces the retainer and forces the distribution needle to pierce the plunger to provide fluid communication with the dose. In some cases, the cover includes a second trigger to release the retainer and the locking mechanism. A spring (e.g., a compression spring) may further move the plunger out of the bottle and reach the injection needle through the distribution needle.

[0022] In some embodiments of the above aspects, the needle extension mechanism may further include: a syringe for supporting the bent injection needle; a spring (e.g., a torsion spring) coupled to the syringe for rotating the syringe to uncoil the bent injection needle; and a syringe locking mechanism to prevent accidental rotation of the syringe. The cover may form a hole through which the distal end of the injection needle passes during rotation of the syringe to straighten the injection needle. In some cases, release of the syringe locking mechanism allows the spring to rotate the syringe and deploy the injection needle. In some cases, the cover includes a first trigger to release the syringe locking mechanism. The needle extension mechanism may also include a syringe cap to secure the proximal end of the injection needle to the syringe.

[0023] In another aspect, the present invention relates to a method of operating a compact high aspect ratio autoinjector for delivering a dose of medication subcutaneously or intramuscularly. The autoinjector may include: a housing; a medication dispensing system including a medication reservoir adapted to contain a dose; and a needle extension mechanism coupled to the medication reservoir, the needle extension mechanism including a curved injection needle. The method may include the steps of: triggering the distal end of the curved injection needle to deploy through a hole in a cover of the housing to straighten the injection needle; triggering puncture of the medication reservoir to provide fluid communication between the reservoir and the curved injection needle; dispensing the dose at a desired injection location through the injection needle; and then, retracting the distal end of the injection needle into the autoinjector.

[0024] In some embodiments of the above aspects, the automatic injector further comprises an interlocking device, so that the housing cannot be rotated relative to the cover or cannot be axially displaced relative to the cover without removing the interlocking device. In some cases, the housing may include a sealed housing rotatably held in the cover, and the method further comprises manually rotating the housing relative to the cover from a first locked position to a second unlocked position, in which the sealed housing is automatically axially displaced relative to the cover to a standby position, thereby increasing the height of the automatic injector. In some cases, the method further comprises the steps of determining the locked position, the unlocked position, and the standby position based on a mark on at least one of the housing, the cover, the label, and the components directly visible to the user. The method may further comprise adhering the cover to the desired injection position before triggering the automatic injector. In some cases, the step of triggering the piercing of the drug reservoir comprises manually compressing the automatic injector when the automatic injector is in the standby position, the manual compression of the automatic injector comprising activating the drug dispensing mechanism, triggering the plunger in the drug reservoir to be pierced with the distal end of the dispensing needle. The step of triggering the piercing of the drug reservoir may further comprise pumping the dose from the reservoir to the injection needle.

[0025] In some embodiments of the above aspects, the step of manually compressing the auto-injector when the auto-injector is in the standby position further includes activating the needle extension mechanism, thereby triggering the bent injection needle to be deployed through the hole in the cover. In some cases, the step of activating the needle extension mechanism to trigger the bent injection needle to be deployed through the hole in the cover further includes rotating the syringe to drive the distal end of the bent injection needle through the hole. In some cases, the step of activating the needle extension mechanism includes deploying the distal end of the bent injection needle through the hole in the cover to straighten the injection needle. The step of retracting the distal end of the injection needle into the auto-injector can be caused by releasing the manual compression of the auto-injector. The method may also include the step of removing the auto-injector from the desired injection position after dispensing the dose. The method may also include the step of automatically interlocking the auto-injector after the needle is retracted to prevent the auto-injector from being used again and to prevent the distal end of the injection needle from being exposed. The method may also include the step of disposing the auto-injector after a single use. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In the drawings, reference numerals generally refer to the same components throughout the different views. Also, the drawings are not necessarily drawn to scale, emphasis instead generally being placed upon illustrating the principles of the invention.

[0027] In the following description, various embodiments of the present invention will be described with reference to the following drawings, in which:

[0028] Figure 1 is a comparison of existing autoinjector form factor aspect ratios and an exemplary high aspect ratio autoinjector according to various embodiments;

[0029] Figure 2 is a diagram of an injection procedure according to various embodiments, indicating user inputs to the auto-injector and subsequent outputs of the auto-injector;

[0030] Figure 3 is a schematic isometric view of an autoinjector in a storage or locked position according to various embodiments;

[0031] Figure 4 is a schematic side view of an autoinjector in a storage or locked position according to various embodiments;

[0032] Figure 5 is a schematic isometric exploded view of the interior of an autoinjector according to various embodiments;

[0033] Figure 6 is a schematic exploded side view of the interior of an automatic injector according to various embodiments;

[0034] Figure 7-11 According to various embodiments (for example, Figure 2Schematic side view of a procedural step in performing an injection according to the embodiment depicted in FIG.

[0035] Figure 12-140 is a schematic diagram of various system components and parts of an automatic injector according to various embodiments; and

[0036] Fig.141 is a chart listing exemplary ranges of values ​​for certain parameters of autoinjectors according to various embodiments. DETAILED DESCRIPTION

[0037] The following describes a first embodiment of the autoinjector 1. Example user interactions and inputs with the autoinjector 1 are first described, followed by a description of example internal mechanisms and component interactions of the autoinjector 1.

[0038] To assist the user in performing proper dosing, the autoinjector 1 should be properly oriented when injecting. The autoinjector 1 may assist with orientation by means of a label, tactile surface, material color or transparency, and / or other markings indicating a selected side. In addition, the autoinjector 1 may provide itself with a rotation assist device MC-301 (see, e.g. Fig.29 ), the rotation assist device can be contoured, textured, coated (or a combination thereof) to further indicate orientation and operation. In addition, the auto-injector 1 can include an observation window to observe the interior of the auto-injector 1 for drug inspection, which can further assist the user in establishing the correct orientation.

[0039] In certain embodiments, the autoinjector 1 includes a safety mechanism SS-200 (see, e.g. Figure 3-7 ), the safety mechanism will initially be removed before any subsequent operation. Once the safety mechanism SS-200 has been removed, the injection surface MC-121 (see e.g. Fig.17 ) can be exposed to the user, which further helps establish the correct orientation. The safety mechanism SS-200 can also provide a means to prevent the sealed housing MC-200, MC-300 from being removed before (see, e.g. Figure 3-6 ) relative to the cap MC-100 (see e.g. Figure 3-6 ) so that the injection procedure cannot be started without first removing the safety mechanism SS-200. Alternatively or additionally, in the event of an accidental discharge or removal of a protective cover or sheath NES-100 that performs a similar function (see, e.g. Figure 38-40 ), the safety mechanism SS-200 can protect the user from the injection needle NES-700 (see e.g. Fig.65 ) injury. Therefore, the removal of the safety mechanism SS-200 can provide or facilitate the following functions: establish the orientation of the automatic injector 1; provide an interlock SS-204 (see, e.g. Figures 101-102) to prevent the sealing housing MC-200, MC-300 from shifting relative to the cover MC-100 before removal; protecting the user from the injection needle NES-700; removing the combined or connected parts NES-100, which will further protect the injection needle NES-700 or protect the user from the injection needle NES-700; and protecting the injection contact surface MC-121 of the cover MC-100 (see, for example Fig.17 ) on a tactile coating or surface.

[0040] In various embodiments, in addition to the internal components discussed below, the automatic injector 1 also includes two main parts: a sealed housing MC-200, MC-300, which is rotatably retained in a cup-shaped cover MC-100, which also forms a bottom side or injection contact surface MC-121. The sealed housing MC-200, MC-300 is made of an upper half MC-300 and a lower half MC-200 that are joined together by means of ultrasonic welding or alternative means that provide sufficient attachment and strength. In some embodiments, the bond between the upper half MC-300 and the lower half MC-200 can be a hermetic seal. In addition, the housing MC-200, MC-300 or one of the subsequent half bodies that constitute the housing MC-200, MC-300 can include a tab MC-210 (see, for example Fig.12 ), the tab is a molded or formed protrusion that guides and constrains the housing MC-200, MC-300 within the cap MC-100 during operation. The sealed housing MC-200, MC-300 serves as the primary interface for the user to perform subsequent injections. The two halves that form the sealed housing have such a geometry (e.g., MC-201, MC-202, MC-204, MC-205, MC-206, MC-207, MC-208, MC-211, MC-213, MC-214, MC-216, MC-217, MC-218, MC-304, MC-305, MC-309, MC-310, MC-311, MC-312, MC-313, MC-314, MC-316) that they can position and secure the internal components.

[0041] The cap MC-100 provides a protective shield around the housing MC-200, MC-300 and supports the housing for rotation. In some embodiments, the first step in performing or starting an injection is to remove the safety mechanism SS-200. The next step may be to place the injection contact surface MC-121 of the cap MC-100 in the appropriate position. As previously described, the safety mechanism SS-200 can help the user establish the overall orientation of the automatic injector 1; therefore, once the injection contact surface MC-121 of the cap MC-100 is exposed from its removal, the orientation can be further established. The injection contact surface MC-121 of the cap MC-100 can provide a tactile surface that can facilitate the following functions: providing a stable base for the automatic injector 1 during injection, helping the user establish orientation, and / or securing the automatic injector 1 to the injection site by an adhesive or other attachment device.

[0042] In various embodiments, the cover MC-100 has a spring SS-300 disposed or formed therein (see, e.g., Figure 5-6 ) is used to bias the housing MC-200, MC-300 away from the cover MC-100 during activation for ease of use. The side wall of the cover MC-100 may include a channel, a slot, a detent, etc. MC-103 (see, for example Fig.15 ), the channels, slots, detents, etc. correspond to different positions MC-117, MC-118, MC-119, MC-120 (see Fig.18 ) or a tab or protrusion MC-210 on the side wall of the housing MC-200, MC-300 or such a part forming the housing MC-200, MC-300 (see Figure 21-22 ) positions (e.g., locked position, unlocked position, standby position, and injection position) to maintain alignment and control relative movement between the various positions (e.g., locked position, unlocked position, standby position, and injection position). The channels, slots, detents, etc. MC-103 formed in the cap MC-100 guide the housing MC-200, MC-300 during the twisting, extension, compression, and subsequent extension of the automatic injector 1 to facilitate the different stages and uses of the injection method. In addition, the cap MC-100 facilitates activation of the interlock device SS-100 (see, e.g., Figure 11-14 ), so that once the cap MC100 is in the injection position MC-120 and the injection is started, the housing MC-200, MC-300 has been subsequently extended relative to the cap MC-100, and the automatic injector 1 cannot be compressed a second time, thereby making the automatic injector 1 a single use. The trigger mechanism MC-109 (see, for example Figure 19-20) is designed so that if the injection needle NES-700 is ever deployed, the interlock SS-100 is always activated before the MDS or NES to ensure that the sharps protection feature works. The cap MC-100 may also include formed, molded or embossed geometric shapes MC-101, MC-102 or markings to provide orientation of the housing MC-200, MC-300 for assembly of the automatic injector 1 or for operational management.

[0043] In various embodiments, when the auto-injector 1 is in the storage position MC-117 and before use, the auto-injector 1 is in a locked position, in which the spring SS-300 is compressed and the auto-injector 1 is restrained. To move from the locked position MC-117 to the unlocked position MC-118, the user rotates the housing MC-200, MC-300 by applying an activation force to a gripping surface MC-301 (e.g., one or more recesses, protrusions, textures, coatings, or a combination thereof, etc.) formed on the upper surface MC-300 of the housing MC-200, MC-300. The force applied by the user causes the sealed housing MC-200, MC-300 to shift from the locked position MC-117 to the unlocked position MC-118 relative to the cover MC-100. Markings (e.g., alignment marks on the side walls of the housing MC-200, MC-300 and the cover MC-100) can indicate different positions (MC-117, MC-118, MC-119, MC-120) of the auto-injector 1. The alignment mark may also be indicated using a label or other component of the automatic injector 1 (e.g., interlock SS-100) that is observable from the outer surface. Once the housing MC-200, MC-300 is rotated from the locked position MC-117 to the unlocked position MC-118, the housing MC-200, MC-300 is biased away from the cover MC-100, and the automatic injector 1 is extended to the standby position MC-119. The extension from the unlocked position MC-118 to the standby position MC-119 is automatically performed by means of the potential energy stored in the biasing member SS-300, so that the user only needs to apply an activation force to the gripping surface MC-301 to move the automatic injector 1 from the locked position MC-117 to the unlocked position MC-118. The automatic translation and rotation of the sealing housing MC-200, MC-300 relative to the cover MC-100 can be constrained and guided by the tabs or protrusions MC-210 on the sealing housing MC-200, MC-300 and the channels, slots, detents, etc. MC-103 on the cover MC-100.

[0044] In various embodiments, once the housing MC-200, MC-300 is in the standby position MC-119, the tabs or protrusions MC-210 on the housing MC-200, MC-300 and the guides on the cover wall MC-103 prevent the housing MC-200, MC-300 from rotating back to the unlocked position MC-118 and the locked position MC-117. In the standby position MC-119, the autoinjector 1 can only be vertically displaced toward the injection position MC-120. The orientation of the autoinjector 1 is such that the top side MC-300 faces upward (i.e., away from the injection position), wherein the flat bottom surface MC-121 of the cover MC-100 abuts against the injection site. To inject the drug, the user applies a normal force perpendicular to the top side MC-300, thereby pushing the sealed housing MC-200, MC-300 into the cover MC-100 to start the activation procedure of the autoinjector 1 and start the injection of the drug. The interlock mechanism SS-100 is activated just before the autoinjector 1 reaches the injection position MC-120, so that once the user releases the pressure, the interlock device SS-100 is engaged and a second injection cannot be attempted. To ensure a full dose, the user maintains force on the sealed housing MC-200, MC-300 to maintain the injection position MC-120 for a specified duration, and then releases the pressure acting on the top side MC-300 of the autoinjector 1. The release of the pressure acting on the sealed housing MC-200, MC-300 can allow the sealed housing MC-200, MC-300 to translate relative to the cover MC-100 with the help of the biasing member SS-300, thereby retracting the needle NES-700. In various embodiments, since the interlock device SS-100 has been previously activated MC-109, they will engage themselves when the sealed housing MC-200, MC-300 translates relative to the cover MC-100. After the injection has been performed and the interlock device SS-100 has engaged with the trigger mechanism MC-109, the force acting on the sealed housing MC-200, MC-300 (at least twice the injection force) will not allow the needle NES-700 to be exposed from the injection contact surface MC-121 of the cover MC-100 and be safely disposed of.

[0045] The following bulleted list (1-11) describes an example activation procedure of the internal components and mechanisms of the autoinjector 1 and the interaction of the various components according to various embodiments.

[0046] 1.) Before initiating an injection, the user can remove the safety mechanism SS-200 before any subsequent operations. The safety mechanism SS-200 protects the injection surface MC-121 so that when removed, the injection surface MC-121 is exposed to the user, which can further help establish the correct orientation. The safety mechanism SS-200 can also provide a device (e.g., an interlock device SS-204) that prevents the sealing housing MC-200, MC-300 from shifting relative to the cover MC-100 before removal, so that the injection procedure cannot be started without first removing the safety mechanism SS-200. The safety mechanism SS-200 can also remove the needle sheath NES-100, which protects the user from the injection needle NES-700 in the event of an accidental discharge. In addition, the sheath NES-100 is connected to the barrier NES-600 (see, for example Figure 38-40 ) combination can cover the injection needle NES-700 and can prevent any possible contamination during the storage of the injection needle NES-700. Therefore, at the time of injection, before removing the needle sheath NES-100, the injection needle NES-700 is sterile.

[0047] 2.) After removing the safety mechanism SS-200, the user can rotate the sealed housing MC-200, MC-300 from the locked position MC-117 to the unlocked position MC-118, whereupon the sealed housing MC-200, MC-300 is automatically moved to the standby position MC-119 by the biasing member SS-300. As a result, the housing MC-200, MC-300 translates and rotates a certain limited distance and angle. When the user applies force and converts the sealed housing MC-200, MC-300 from the standby position MC-119 to the injection position MC-120, the mechanism that initiates the internal activation program within the sealed housing MC-200, MC-300 is a trigger or protrusion MC-106, MC-107 (see, e.g. Figure 15-16 ). The activation trigger or protrusion MC-106, MC-107 can be molded or formed on the surface of the cover MC-100. The cavity MC-202 (see e.g. Figure 22-23 ) is molded or formed in the bottom half MC-200 of the sealed housing MC-200, MC-300 to allow the sealed housing MC-200, MC-300 and the cover MC-100 to rotate and translate relative to each other without interfering with or damaging the activation mechanism MC-106, MC-107 or the alignment mechanism MC-105 (see, e.g. Figure 19-20). During assembly, activation and injection, the protrusions or tabs MC-210 molded or formed on the sealed housing MC-200, MC-300 and the corresponding channels, slots, detents, etc. MC-103 on the cover MC-100 can be docked to provide sufficient clearance and alignment to prevent damage to the protrusions or triggers on the covers MC-105, MC-106, MC-107. The cover MC-100 can also have an alignment post or protrusion MC-105, which aligns with the corresponding cavity MC-211 in the sealed housing MC-200, MC-300 (see, for example, when the automatic injector 1 is in position MC-120) during injection. Fig.23 ) docking, so that they can help align the sealed housing MC-200, MC-300 and the cover MC-100 to utilize the corresponding locking mechanism NES-500 (see for example) provided in the sealed housing MC-200, MC-300 Figure 38-41 ), MDS-100 (see e.g. Figures 69-73 ) triggers MC-106, MC-107 on the directional cover MC-100. In some embodiments, the cover MC-100 and / or the sealed housing MC-200, MC-300 may include additional features (e.g., MC-103, MC-104, MC-109, MC-115, MC-210, SS-102) that help maintain alignment between the sealed housing MC-200, MC-300 and the cover MC-100 during relative movement.

[0048] 3.) When the user applies force to the top surface MC-300 of the sealing housing MC-200, MC-300 to press the sealing housing MC-200, MC-300 into the cover MC-100 to perform an injection, the first system to be activated may be the interlock system SS-100. The interlock system SS-100 is activated first to ensure that when the user deploys the needle extension system (NES), the interlock system SS-100 will always engage with the trigger mechanism MC-109. In some embodiments, when the sealing housing MC-200, MC-300 is compressed during an injection, the interlock device SS-100 is activated by the interference fit between the cover MC-109 and the interlock device SS-101 (see, e.g. Figures 98-100 ). After injection and release of the pressure acting on the sealed housing MC-200, MC-300, the sealed housing MC-200, MC-300 can be automatically displaced relative to the cover MC-100, and the interlocking device SS-100 is deployed or engaged. Before activation, the interlocking device SS-100 can be kept in the cavity MC-201 in the sealed housing MC-200, MC-300 in a storage state (see, for example Fig.103 ), MC-314 (see e.g. Figure 29-34)middle.

[0049] 4.) After activating the interlock SS-100, the needle extension system (NES) may be activated. The corresponding needle extension trigger or protrusion MC-107 on the cover MC-100 is in a predetermined position MC-203 (see e.g. Fig.23 ) in the sealing housing MC-200, MC-300 and contact the fixing or locking mechanism NES-500 of the NES. The fixing or locking mechanism NES-500 of the NES can save the potential energy of the biasing member NES-800 (see, for example Figures 67-68 ). The biasing member NES-800 may be provided at a designated contact point NES-202 (see e.g. Figures 48-50 ) is connected to the syringe NES-200 (see for example Figures 46-50 In one embodiment, the biasing member NES-800 is a torsion spring that causes the syringe NES-200 to rotate. The fixing or locking mechanism NES-500 may be provided by an interfering portion NES-201 of the syringe NES-200 (see, e.g., Fig.47 ) to maintain the potential energy of the torsion spring NES-800. The contact portion NES-501 between the needle extension trigger or protrusion MC-107 on the cover MC-100 and the fixing or locking mechanism NES-500 (see, e.g. Figure 60-62 ) disengages the locking mechanism NES-500, thereby releasing the potential energy stored in the torsion spring NES-800. The release of the torsion spring NES-800 causes the syringe NES-200 to rotate and the curved injection needle NES-700 to deploy. The housing may have an internal geometric structure portion MC-307 (see, e.g. Fig.31 ) to facilitate the disengagement of the locking mechanism NES-500 during injection.

[0050] 5.) Once the locking mechanism NES-500 is disengaged from the syringe NES-200, the torsion spring NES-800 can rotate the syringe NES-200. The injection needle NES-700 can be rotated by making the element NES-308 (see e.g. Figure 53-54 ) a syringe cap NES-300 that cooperates with a corresponding recess NES-207 formed in the syringe NES-200 (see, e.g. Figure 51-54 ) is fixed and retained in the syringe NES-200. The syringe cap NES-300 can be fixed and retained in the syringe NES-200 by the element NES-306 (see for example Figure 53-54 ), NES-206 (see e.g. Figures 46-47 ) between the friction fit between the injection needle NES-700 fixed to the syringe NES-200. In addition, the syringe cap NES-300 can be fixed by the element NES-304 (see Fig.51 )、MES-305(See Fig.51 )、NES-204(See Fig.49 ), NES-205 (see Fig.49 ) to form a friction fit or press fit to connect the flexible tube NES-900 (see Fig.40 ) is fixed to the injection needle NES-700. In addition, the syringe cap NES-300 provides a contact surface NES-301 (see Fig.52 ), which is used to limit the rotation of the syringe NES-200 to a specific angle. In various embodiments, the bottom half MC-200 of the sealed housing MC-200, MC-300 provides an interface MC-218 (see, for example, Figure 21-22 ), the interface MC-218 contacts the syringe cap NES-300 during rotation to limit the angular displacement of the syringe NES-200 to a desired rotation angle, which is proportional to the desired injection depth. The syringe cap NES-300 and the sealed housing MC-200, the bottom half MC-200 of the MC-300 work together to prevent the injection needle NES-700 from over-rotating and ensure that the proper injection depth is achieved. During rotation, the syringe NES-200 passes through a guide (e.g., NES-203 (see NES-203) formed in the half (e.g., MC-207, MC-312, MC-316, MC-302, MC-310, MC-309, MC-216) of the sealed housing MC-200, MC-300 Fig.46 ), NES-303 (see Fig.51 ), NES-208 (see Fig.48 )) and the syringe guide NES-400 (see Figure 55-59 ) along its axis of rotation. These guides can maintain axial alignment and prevent the syringe NES-200 and injection needle NES-700 from translating relative to the sealed housing MC-200, MC-300 during injection. The syringe guide NES-400 can also provide a channel NES-401 (see Fig.55 ) to support and guide the NES locking mechanism NES-500 during storage and injection of the auto-injector 1 (see e.g. Figure 60-62 In some embodiments, the syringe cap NES-300 can be ultrasonically welded (see welding section NES-210 ( Fig.49 )、NES-307( Fig.51 )) Or another means of combining the two components together can be utilized. In addition, during assembly, the NES component of the system can be integrated independently of the housing MC-200, MC-300.

[0051] 6.) When the injection needle NES-700 is rotated, the distal end of the bent injection needle NES-701 (see Figures 65-66) through the hole MC-204 formed in the lower half MC-200 of the sealed housing MC-200, MC-300 (see Fig.23 ) and with the needle guide MC-110 on the cover MC-100 (see Fig.19 ) contacts, so that a portion of the bent injection needle NES becomes straight during unwinding. The injection needle NES-700 contacts the surfaces MC-112, MC-113 on the needle guide MC-110 (see Fig.19 ) can be positioned so that the distal NES-701 (e.g., lancet) does not contact the guide MC-110 to reduce the chance of scratching or scraping the needle guide MC-110 and reduce the chance of generating debris. In addition to the needle guide MC-110, the sealed housing MC-200, MC-300 can also provide a support MC-309 (see Figure 31-34 ) to further limit possible radial (relative to the needle axis) deflection during injection.

[0052] 7.) After the syringe locking mechanism NES-500 has been disengaged by the first trigger MC-107, the housing MC-200, MC-300 is further compressed into the cover MC-100, which allows the second trigger MC-106 to initiate the release of the drug dispensing system (MDS) and deliver the drug. Similar to the NES, the drug dispensing trigger MC-106 contacts the corresponding fixed or locking mechanism MDS-100 MDS-101 and releases the locking mechanism MDS-100. When the fixed or locking mechanism MDS-100 is in the predetermined position MC-203, the trigger MC-106 is in the interface portion MDS-101 (see Fig.74 The fixing or locking mechanism MDS-100 maintains the potential energy stored in the biasing member MDS-700 (see Fig.72 In one embodiment, the biasing member MDS-700 is a compression spring which is formed by the retainer MDS-400, MDS-300 (see Figure 72-73 ) and holder MDS-200 (see Figure 72-73 ) constraint. The release of the fixing or locking mechanism MDS-100 allows the retainers MDS-300, MDS-400 to shift relative to the retainer MDS-200, thereby making contact with the plunger MDS-900 (see Fig.72 ). After contacting the plunger MDS-900, the retainers MDS-300, MDS-400 and the plunger MDS-900 are displaced together. The total displacement of the retainers MDS-300, MDS-400 and, subsequently, the plunger MDS-900 is determined by the retainer MDS-200, which may provide an interference feature or other feature MDS-201 (see Figures 78-80 )、MDS-309(See Figures 81-84 )、MDS-409(See Figures 85-88 ) to limit the movement of the retainers MDS-300 and MDS-400. In this way, the displacement of the retainers MDS-300 and MDS-400 relative to the retainer MDS-200 can be proportional to the amount of medicine discharged from the reservoir MDS-800 (see Figures 94-95 ). In addition, the housing MC-200, MC-300 may have a sufficient internal geometry MC-306 (see Fig.31 ) to assist in disengagement of the fixation or locking mechanism MDS-100 during injection.

[0053] 8.) Release the fixing or locking mechanism of the MDS MDS-100 (see Fig.74 ), due to the potential energy stored in the compression spring MDS-700, the retainers MDS-300 and MDS-400 can be displaced and contact the plunger MDS-900. The dispensing needle MDS-600 can be connected to the retainers MDS-300 and MDS-400 and in fluid contact with the injection needle NES-700 through the flexible tube NES-900. In addition, the dispensing needle MDS-600 is protected by the protective barrier MDS-500 like the injection needle NES-700 to prevent any contamination before injecting MC-120. Therefore, the release of the compression spring MDS-700 causes the retainers MDS-300 and MDS-400 to contact the plunger MDS-900, thereby forcing the dispensing needle MDS-600 to pierce both the protective barrier MDS-500 and the plunger MDS-900. The drug is discharged from the reservoir MDS-800 in the opposite direction to the movement of the plunger MDS-900 from the dispensing needle MDS-600 (see Fig.91 ) are distributed. In various embodiments, the retainers MDS-300, MDS-400 are welded by ultrasonic welding (for example, with welding parts MDS-405, MDS-305 (see Fig.84 , 85 )) or by alternative means providing adequate attachment and strength. The retainer halves MDS-300, MDS-400 may be friction fit (MDS-602, MDS-302, MDS-402 (see Fig.82 , 84 , 91)) to fix the dispensing needle MDS-600. In addition, the retainer half MDS-300, MDS-400 can be friction-fitted or press-fitted with MDS-303, MDS-304, MDS-403, MDS-404 (see Figures 83-85) secures the flexible tube NES-900 to the dispensing needle MDS-600 to prevent any possible detachment during dispensing. When assembled together, each half of the holder MDS-300, MDS-400 can have an orientation feature MDS-301, MDS-401 (see Figures 83-85 ), this orientation feature forces the two halves MDS-300, MDS-M to align correctly during assembly, and it can also play a role in keeping the dispensing needle MDS-600 and the tube NES-900 in correct alignment. In order to maintain the sealed reservoir MDS-800 and not contaminate the drug, during injection, the dispensing needle MDS-600 can only penetrate the protective barrier MDS-500 (see Figures 89-90 ) and plunger MDS-900.

[0054] 9.) The needle extension trigger and drug dispensing trigger MC-106, MC-107 that activate NES and MDS respectively can have their respective locking mechanisms NES-501 at the contact point (see Figure 60-62 )、MDS-101(See Fig.74 ) complementary contoured surfaces to reduce the force required for disengagement and limit the stress induced in the trigger MC-106, MC-107. In addition, via the predetermined interaction position MC-203, the housing MC-200, MC-300 can provide a support MC-219 (see Fig.26 ) to limit any possible deflection in the trigger MC-106, MC-107 caused by the breakaway force.

[0055] 10.) Proximal end of the dispensing needle MDS-600 MDS-604 (see Fig.91 ) can be connected to the proximal end NES-703 of the injection needle NES-700 through a section of flexible hose or flexible tube NES-900 (see Fig.65 ) fluid connection. The timing of activation of the NES and MDS can allow the injection needle NES-700 to be embedded in the tissue and then dispense the drug within a specified or predetermined time frame.

[0056] 11.) After injection and release of the pressure on the sealed housing MC-200, MC-300 by the user, the sealed housing MC-200, MC-300 can automatically translate relative to the cover MC-100 due to the biasing element SS-300. In some embodiments, the biasing member is a compression spring SS-300. During the subsequent extension of the sealed housing MC-200, MC-300, the interlocking device SS-100 is removed from its cavity MC-201, MC-314 and limits any relative movement between the sealed housing MC-200, MC-300 and the cover MC-100. The interlocking device SS-100 prevents the automatic injector 1 from collapsing, thereby preventing the distal end NES-701 of the injection needle NES-700 from subsequently extending from the cover MC-100. The extension of the sealed housing MC-200, MC-300 relative to the cover MC-100 is sufficient to completely withdraw the injection needle NES-700 and hide it in the automatic injector 1. In addition, the channel, slot, detent, etc. MC-103 in the cover MC-100 and the molded or formed tab or protrusion MC-210 on the sealing housing MC-200 can prevent any rotation of the cover MC-100 or the sealing housing MC-200, MC-300 relative to each other. The interlock device SS-100 can prevent the subsequent collapse of the automatic injector 1 and make the cover MC-100 or the housing MC-200, MC-300 unable to rotate, which allows a safe disposal method to prevent accidental exposure of the needle NES-700.

[0057] The following paragraphs describe another embodiment of the autoinjector 1 , which includes alternative or complementary configurations and activation procedures of the autoinjector 1 .

[0058] In this embodiment, the auto-injector 1 may have an internal power source to allow certain functions of the auto-injector 1 during storage, during injection, and after injection. The auto-injector 1 may provide auditory instructions for performing the injection. In addition, the connection of the auto-injector 1 to everyday smart devices allows additional functionality. The connected smart device may display visual and / or auditory instructions for performing the injection. Certain embodiments may allow the user to monitor the temperature and location of the auto-injector 1. In addition, the connected device may allow the user to see if there are other auto-injectors 1 nearby. Once the injection has been initiated, additional embodiments may allow the smart device to contact emergency responders or next of kin. In addition, information related to the auto-injector 1 may be remotely monitored by the manufacturer.

[0059] Similar to the above embodiment, this embodiment can establish the orientation of the auto-injector 1 before any injection is performed through appropriate human factors engineering principles. The auto-injector 1 can provide an intuitive interface for the user by leveraging existing mental models in daily use. With respect to the user interface, additional or alternative embodiments will provide the same benefits through possible variations in the following aspects: Geometry or element 1101 (see Fig.115 ), tactile surfaces, markings, labels and / or coloring, which can help the user establish orientation prior to performing an injection.

[0060] In some embodiments, the auto-injector 1 includes a safety mechanism SS-200 that is removed prior to any subsequent operation. Once the safety mechanism SS-200 has been removed, the injection surface MC-121 is exposed to the user, further helping to establish the correct orientation. The safety mechanism SS-200 may also provide a means of preventing the auto-injector 1 from being removed from the locked position 3102 (see FIG. Figures 110-111 ) moves to the unlocked position 3103, 3104 (see Figures 110-111 ) so that an injection procedure cannot be initiated without first removing the safety mechanism SS-200. Alternatively or additionally, the safety mechanism SS-200 can protect the user from the injection needle 4102 if an accidental discharge occurs or a protective shield or sheath NES-100 is removed that can facilitate a similar function (see Fig.122 ). Thus, removal of the safety mechanism SS-200 may provide or facilitate the following functions, such as: establishing the orientation of the automatic injector 1; providing an interlock SS-204 to prevent rotation of the sealing housing prior to removal; protecting the user from the injection needle 4102; removing the incorporated or coupled component NES-100 that further protects the injection needle 4102 or protects the user from the injection needle 4102; and protecting the tactile coating or surface on the injection contact surface MC-121 of the cap 3100 (see Figures 110-111 ).

[0061] In addition to the internal components discussed below, the autoinjector 1 may also include two main parts, namely a sealed housing 1100, 2100 rotatably retained in a cup-shaped cover 3100 (see Figures 105-107), the cover may also form the bottom side or injection contact surface MC-121. The sealed housing may be made of an upper half 1100 and a lower half 2100 joined together by means of ultrasonic welding or by alternative means that provide sufficient attachment and bonding strength. In some embodiments, the bond between the upper half 1100 and the lower half 2100 may form a hermetic seal. In some cases, the housing 1100, 2100 or one of the subsequent halves 1100, 2100 that make up the housing 1100, 2100 includes a molded or formed protrusion 2107 (see Figures 112-113 ), the protrusion guides and constrains the housing 1100, 2100 within the cover 3100 during operation. The sealed housing 1100, 2100 can be used as the primary interface for the user to perform an injection. In addition to the hermetically sealed housing 1100, 2100, the sealed housing 1100, 2100 can also include an additional sealing component MC-215 (see Fig.26 ), MC-315 (see Figure 31-32 ) or a composite to completely enclose the interior chamber of the housing. The sealed chamber can perform the following functions, such as: providing and maintaining the desired cleanliness standards inside; providing a waterproof shell; and allowing a pressure difference between the internal and external environments. Some embodiments of the automatic injector 1 can preserve the desired internal conditions until the injection. The two halves 1100, 2100 forming the sealed housing can have geometric structures and / or components (e.g., 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 2101, 2102, 2103, 2104, 2105, 2106, 2108, 2109, 2110, 2112, 2113) that can position and fix the internal components.

[0062] The following bulleted list (1-14) describes another example activation procedure of the internal components and mechanisms of the autoinjector 1 and the interaction of the various components according to various embodiments.

[0063] 1.) When the user unlocks the housing 1100, 2100 from the cover 3100, the housing 1100, 2100 automatically moves to the standby position 3103 (see Figures 110-111). The housing 1100, 2100 translates and rotates certain limited distances and angles. The mechanism for activating the internal activation program inside the sealed housing is a trigger or protrusion MC-106, MC-107, which is molded or formed on the surface of the cover 3100. Cavities MC-202, MC-211 are molded or formed in the lower half 2100 of the sealed housing 1100, 2100 to allow the sealed housing and the cover 2100 to rotate and translate relative to each other without interfering with or damaging the activation mechanism or alignment mechanism. During assembly (see position 3105), activation (see positions 3102, 3103) and injection (see position 3104), the protrusion or tab 2107 molded or formed on the sealed housing 1100, 2100 and the corresponding channels, slots, detents, etc. 3106, 3108, 3107 on the cover 3100 (see Fig.110 ) to provide sufficient clearance and alignment to prevent damage to the protrusions or triggers MC-106, MC-107 on the cover 3100. In addition, the cover 3100 can have alignment posts or protrusions MC-105 that mate with corresponding cavities MC-211 in the sealed housing 1100, 2100 during injection so that they can help align the sealed housing 1100, 2100 and the cover 3100 to utilize the corresponding locking mechanism 5100 (see Fig.136 )、7110(See Fig.116 ) Orient the trigger MC-106, MC-107 on the cover 3100. In addition, the cover 3100 and / or the sealed housing 1100, 2100 may include additional features that help maintain the alignment between the sealed housing 1100, 2100 and the cover 3100 during relative movement. The automatic extension can be provided by a spring 3101 disposed therein or formed therein (see Figures 108-111 ) occurs to bias the housing 1100, 2100 away from the cover 3100 during activation, thereby facilitating use. In some embodiments, the housing 1100, 2100 can return to the locked position 3102 and maintain the internal sealing of the sealed housing. To return to the locked position 3103, 3104, the user compresses the housing 1100, 2100 into the cover 3100 and rotates the housing 1100, 2100 in the opposite direction.

[0064] 2.) In certain embodiments, the internal injection needle 4102 is not aligned with the needle hole MC-112 formed in the bottom side of the cap 3100. Therefore, if the injection needle 4102 is inadvertently unable to be activated, the sharp distal end of the needle NES-701 will not penetrate the bottom side of the cap MC-121. The user can verify the positioning of the housing 1100, 2100 relative to the cap 3100 with the help of the markings and labels present on the auto-injector 1.

[0065] 3.) Once the auto-injector 1 is in the unlocked position MC-118 and has been moved to the activated position 3103, 3104, the housing 1100, 2100 can be freely rotated without interfering with the trigger MC-106, MC-107. Before the auto-injector 1 is manually compressed to facilitate injection, if it has been accidentally moved to the activated position 3103, the housing 1100, 2100 can be reset or returned to the locked position 3102.

[0066] 4.) When the housing 1100, 2100 is compressed into the cover 3100, thereby switching from the standby position 3104 to the injection position MC-120, the trigger or protrusion MC-106, MC-107 on the cover 3100 pierces the designated position MC-203 on the housing 2100, thereby contacting the corresponding locking member 5100, 7110 and starting the injection procedure. In order to allow the trigger MC-106, MC-107 to penetrate the bottom side of the lower half 2100 of the housing without causing any loose cracks or damaging the structure of the trigger MC-106, MC-107. Therefore, the area MC-203 penetrated by the trigger MC-106, MC-107 can contain perforations or other auxiliary materials MC-219 (for example, different materials, etc.).

[0067] 5.) When the user compresses the autoinjector 1 to perform an injection, the first trigger MC-107 pierces the lower half 2100 of the housing and initiates the unwinding of the curved injection needle 4102. Unwinding is initiated by disengaging the first trigger MC-107 from the locking mechanism 5100. The first trigger MC-107 pierces the housing and contacts the unwinding locking mechanism 5100. The unwinding locking mechanism 5100 is disengaged by retracting from the syringe 4100 (see Figures 125-130 ), the unwinding locking mechanism is seated on the syringe during the storage, activation and standby positions 3102, 3103, 3104. The housing 1100, 2100 can have a sufficient internal geometry (see elements MC-306, MC-307 (see Fig.31 )) to assist the locking mechanism 5100, 7110 to disengage during injection. Before engaging with the first trigger MC-307, the injection needle 4102 can be prevented from unwinding by the unwinding locking mechanism 5100, thereby preventing the syringe 4100 from rotating. Therefore, the corresponding torsion spring 8100 remains wound and under load. In this embodiment, a portion of the injection needle 4102 has a spiral shape before injection and has a straightened shape during injection. The spiral shape of the injection needle 4102 allows the automatic injector 1 to maintain a low profile and a high aspect ratio. In addition, the needle 4102 can be made of a material that will not be damaged during manufacturing or will not unwind during injection.

[0068] 6.) Once the locking mechanism 5100 is disengaged from the syringe 4100, the torsion spring 8100 allows the syringe 4100 to rotate freely to a set angle. The injection needle 4102 can be fixed to the holder 4103 (see Fig.122 ), which is formed with a corresponding recess 4112 in the syringe 4100 (see Figures 125-126 ) When the syringe 4100 rotates, a portion of the spiral injection needle 4102 unwinds. In this embodiment, the portion of the needle 4102 that is bent before injection can be straightened and embedded in the tissue during injection. A pair of opposing ribs 2102 (see FIG. 21) molded into the upper half 1100 and the lower half 2100 of the housing Fig.108 )、1104(See Figures 114-115 ) holds the syringe 4100 in place and maintains proper alignment during unwinding and rewinding. In addition, a rib or housing 4113 (see Figures 125-126 ), 1104, 2102 or having a geometric structure that guides and allows the injection needle 4102 to be detached from the syringe 4100 (see element 1103 (see Figures 114-115 )、2103(See Fig.112 )).

[0069] 7.) The distal end NES-701 of the spiral injection needle 4102 passes through the hole 2111 formed in the lower half 2100 of the housing (see Figures 112-113 ), so that the injection needle 4102 is straightened during unwinding by the hole 2111, which has a size similar to that of the injection needle 4102. By the interference element 4107 (see Figures 125-127 ) controls the rotation of the syringe 4100, which ensures that the syringe 4100 rotates to the desired predetermined angle, thereby ensuring that the distal end NES-701 of the needle 4102 stops at the desired injection depth.

[0070] 8.) Additionally, when the distal end NES-701 of the needle 4102 exits the lower half 2100 of the housing, it can pass through and pierce the seal covering the hole 2111. The seal acts as a barrier between the interior of the housing 1100, 2100 and the external environment. The seal can be an adhesively adhered TPE film (e.g., The TPE film keeps the housing 1100, 2100 hermetically sealed. In addition, this type of seal allows the distal end of the needle 4102 NES-701 to pass through without removing any material, thereby avoiding the cork effect and partial or complete blockage of the lumen or hole of the needle 4102 during injection. The seal can also ensure that the sterile internal environment of the housing is maintained.

[0071] 9.) Once the unwinding rotation of the syringe 4100 is completed, the torsion spring 8100 can be disengaged from the syringe 4100. Because the unwinding spring tensioner 4104 (see Fig.128 ) includes a torsion spring contact point 4106 (see Fig.128 ) and having a non-circular shape with a collar surface 4105 (see Figures 129-130 ), so the torsion spring 8100 can be disengaged from the syringe 4100. In one embodiment, due to the non-circular collar 4105, the torsion spring contacts the surface 4114 (see Figures 137-138 ) causes the torsion spring 8100 to deflect axially, thereby allowing the proximal end 8103 of the torsion spring 8100 (see Fig.140 ) rises and extends from the contact point 4106 on the syringe 4100 and disengages from the syringe 4100. The occurrence of disengagement can make it unnecessary to rewind the unwinding torsion spring 8100, which performs the rewinding of the injection needle 4102 onto the syringe 4100.

[0072] 10.) After the syringe locking mechanism 5100 has been disengaged by the first trigger MC-107, further compression of the housing 1100, 2100 into the cap 3100 allows the second trigger MC-106 to initiate the dispensing of the drug. The plunger 7102 associated with the reservoir or bottle 7100 containing the drug is pushed or driven forward by the compression spring 7106, which in turn dispenses the drug. When the second trigger MC-106 releases the retainer 7101 that constrains and holds the compression spring 7106 in the storage position, the compression spring 7106 is actuated. The compression spring 7106 drives the retainer 7101 and, in turn, drives the plunger 7102 into the bottle 7100 to force the drug out of the bottle 7100 through the dispensing port 7104.

[0073] 11.) The proximal end NES-703 of the injection needle 4102 is fluidly connected to the dispensing port 7104 through a section of flexible hose or flexible tubing NES-900. The timing of the unwinding NES and the drug administration MDS is such that the delivery of the injection NES and the drug MDS occurs within a short designated time window (e.g., a few seconds after compression).

[0074] 12.) Once the auto-injector 1 has been pressed against the injection site and the injection has begun, the person holds the auto-injector 1 against the injection site for a specified duration. After releasing the pressure on the auto-injector 1, after the specified duration, the rewinding of the injection needle 4102 begins. Due to the biasing member 3101, the housing 1100, 2100 automatically extends and releases the third locking mechanism 9100 (see Figures 133-134 ), which in turn activates the rewind torsion spring 8101 (see Fig.129 ).

[0075] 13.) When the auto-injector 1 is in the compressed configuration, the rewinding torsion spring 8101 can be tightened by another tensioner 9101 (see Figures 131-132 ) and retainer 9100 are maintained in a wound state. The rewind spring retainer 9100 can maintain the tension of the rewind torsion spring 8101 during compression and dose injection of the automatic injector 1. Note that the rewind spring 8101 can be disengaged from the syringe 4100 during the unwinding of the injection needle 4102. After extension, after injection, the rewind spring 8101 can engage the interference element 4107 of the syringe 4100, causing the injection needle 4102 to rewind. The axial movement of the syringe 4100 during the unwinding process promotes this engagement 4107 of the rewind spring 8101 on the syringe 4100. In order to prevent the rewind torsion spring 8101 from unwinding (and prematurely rewinding the injection needle 4102) once the unwind spring 8100 is disengaged from the syringe 4100, the trigger MC-106 actuates the rewind spring retainer 9100, causing the entire automatic injector 1 to compress and act as a temporary spring retainer until the automatic injector 1 is extended.

[0076] 14.) Once the autoinjector 1 is allowed to extend after the injection has been completed, the trigger MC-106 disengages, releasing the tensioner 9101 and allowing the rewind torsion spring 8101 to rewind the injection needle 4102 into the housing 1100, 2100. The interlock SS-100 then prevents the injection needle 4102 from being able to be deployed again.

[0077] The following table provides the names and brief descriptions of the reference numbers that appear in the accompanying drawings:

[0078]

[0079]

[0080]

[0081]

[0082]

[0083]

[0084]

[0085]

[0086]

[0087]

[0088]

[0089]

[0090]

[0091]

[0092] It is intended that each numerical value provided herein represents an exemplary minimum or maximum value within the range of the corresponding parameter. Therefore, according to the teachings herein, when these exemplary numerical values ​​are added to the claims, the exemplary numerical values ​​provide clear support for claiming the range, which can be higher or lower than the numerical value. Fig.141 Every value between the minimum and maximum value within each numerical range provided in the illustrated graphs is contemplated and expressly supported herein, subject to the number of significant digits expressed within each specific range.

[0093] The terms and expressions used herein are used as terms and expressions of description, but not limitation, and when such terms and expressions are used, it is not intended to exclude any equivalents of the features shown and described or parts thereof. In addition, although certain embodiments of the present invention have been described, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein can be used without departing from the spirit and scope of the present invention. The structural features and functions of some embodiments can be arranged in various combinations and arrangements, and are all considered to fall within the scope of the disclosed invention. Unless otherwise necessary, the steps recorded in the various methods can be performed in any order, and certain steps can be performed substantially simultaneously. Therefore, the embodiments described should be considered to be exemplary and non-restrictive in all respects. In addition, the constructions described herein are intended to be illustrative and not restrictive. Similarly, although physical explanations have been provided for explanatory purposes, it is not intended to be bound by any particular theory or mechanism or to limit the claims based on this.

Claims

1. A compact high aspect ratio autoinjector for subcutaneous or intramuscular delivery of a drug dose, the autoinjector comprising: case; a drug dispensing system disposed within the housing and comprising a drug reservoir adapted to contain the drug dose; as well as A needle extension mechanism is coupled to the drug reservoir, the needle extension mechanism comprising a curved injection needle and a needle guide adapted to straighten the curved injection needle during deployment of the curved injection needle through the needle guide to facilitate dispensing of the dose by the automatic injector.

2. The automatic injector of claim 1, wherein the housing comprises a sealed housing rotatably retained in the cap.

3. The autoinjector of claim 2, wherein the housing further comprises an interface that receives user input to facilitate manual rotation of the housing relative to the cap from a first locked position to a second unlocked position.

4. The autoinjector of claim 3, wherein at least one of the housing, the cap, the label, and the component directly visible to the user includes indicia indicating the locked position, the unlocked position, and the armed position.

5. The autoinjector of any one of claims 1 to 4, wherein the drug dispensing system further comprises a plunger within the drug reservoir and forming a sealed cavity for retaining the dose.

6. The autoinjector of any one of claims 1 to 4, wherein the drug dispensing system further comprises a dispensing needle in fluid communication with the injection needle.

7. The autoinjector of claim 6, further comprising a flexible tube interconnecting the dispensing needle with the injection needle.

8. An automatic injector according to any one of claims 1 to 4, wherein the drug dispensing system further comprises a spring, a retainer and a locking mechanism, such that when the locking mechanism is released, the spring displaces the retainer and forces the dispensing needle to pierce the plunger to provide fluid communication with the dose.

9. The autoinjector of any one of claims 1 to 4, wherein the needle extension mechanism further comprises: A syringe, which is used to support the curved injection needle; a spring coupled to the syringe for rotating the syringe to deploy the curved injection needle; and a syringe locking mechanism for preventing accidental rotation of the syringe.

10. A compact autoinjector device for delivering a dose of a drug to a user, the device comprising: a first sterile chamber containing a distal end of a dispensing needle and positioned proximate a drug reservoir containing the drug dose; as well as A second sterile chamber is remote from and not adjacent to the first sterile chamber and contains a distal end of an injection needle that is fluidly coupled to the dispensing needle.

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