Compact auto-injector

Abstract

To provide a suitable compact automatic injector.SOLUTION: A novel single use auto-injector for delivering a fixed amount of medicament is described. The auto-injector may include a sealed housing rotatably held in a cover. Once the auto-injector is positioned at the injection location, a user can transition the housing from a locked to an armed position. The user can then compress the sealed housing into the cover and trigger activation mechanisms that initiate the injection. A first activation mechanism engages an interlock to prevent reuse of the auto-injector. A second activation mechanism straightens and extends a curved needle to a set the exposed needle length. A third activation mechanism pierces a sealed reservoir, allowing the medicament to be forced through the injection needle. Following the injection, the auto-injector expands and interlocks, retracting the needle into the auto-injector and preventing reuse.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 552,052, filed August 30, 2017, entitled "Compact Auto-Injector," and U.S. Provisional Patent Application No. 62 / 568,567, filed October 5, 2017, entitled "Protective Case for an Auto-Injector," the contents of both of which are incorporated herein by reference in their entireties.

[0002] (Technical field) The present invention relates generally to automatic medication injectors, and more particularly to relatively low profile and high aspect ratio automatic injectors that allow for the administration of a desired dose of medication intramuscularly or subcutaneously. [Background technology]

[0003] The auto-injector market is growing rapidly through increased prescriptions along with signs of new uses. Auto-injectors are becoming more prevalent because they offer an innovative approach to administering drugs or biologics, promoting safety, improving dosing accuracy, and potentially increasing patient compliance, especially in self-administration settings.

[0004] Existing auto-injectors cause patients to actively seek alternatives to address the anxiety experienced by patients associated with existing problems: poor portability, unnecessary attention, accidental injection, and lacerations. Improved auto-injectors are needed. Summary of the Invention [Means for solving the problem]

[0005] Through human-centered design, auto-injector embodiments described herein are portable, intuitive, and easy to use. Auto-injector technology is variably applicable to many use indications requiring a fixed-dose, single-use intramuscular or subcutaneous injection. Auto-injector embodiments are designed to consider human factors. The enhanced ergonomics of device embodiments, combined with high aspect ratio syringe technology, are designed to fit modern lifestyles. Embodiments of the present invention include high aspect ratio auto-injector technology that enables the creation of portable and wearable auto-injectors for the safe and effective administration of epinephrine and other medications. (Note that the exemplary value ranges in the chart in FIG. 141 relate to the delivery of multiple medications, but can be adjusted as needed to accommodate the delivery of other medications.) FIG. 1 provides an exemplary illustration of how the aspect ratio of an auto-injector is calculated using both a conventional auto-injector and the inventive auto-injector described herein. As used herein, with reference to FIG. 1, height (H) is defined as the maximum linear length of the auto-injector away from the skin during injection (perpendicular to the injection surface), and width (W) is measured as the minimum linear length above the surface in contact with the patient's skin during injection (parallel to the injection surface).

[0006] 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 available in an emergency. The objectives of a safe, easy-to-use, portable, and wearable auto-injector, as well as other objectives, will be apparent to those skilled in the art.

[0007] In one aspect, the present invention is a compact auto-injector for delivering a drug dose subcutaneously or intramuscularly. The auto-injector may consist of two main components: a sealed housing and a cover. Inside the sealed housing are located a drug reservoir containing a drug, a drug dispensing system (MDS), and a needle extension system (NES). During injection, the drug reservoir and the needle extension system are in fluid connection.

[0008] The sealed housing may be rotatably retained within the cover. In one embodiment, the sealed housing may be rotated relative to the cover from an initial position to a second position following user input through a designed interface. At least one of the components comprising the sealed housing or the cover may include indicia indicating the first, second, or subsequent position. The sealed housing may be constrained and supported during transition so that the sealed housing may be displaced relative to the cover in a controlled manner. The automatic injector may further include a biasing member whose function includes displacing the sealed housing relative to the cover. In various embodiments, the biasing member may be a spring integrally formed with the sealed housing or cover, or conversely, a separate component that may be positioned between the sealed housing and the cover. The automatic injector may further include an interlocking device so that the sealed housing cannot be displaced unless a mechanism is removed or released by the user when use of the automatic injector is desired.

[0009] To assist the user in performing the proper dose, the auto-injector should be properly oriented during injection. The auto-injector may aid in orientation using markings, tactile surfaces, material color or transparency, and other indicia to indicate the selected side. Furthermore, while the auto-injector may exist with a rotational aid, the aid may be contoured, textured, coated, or a combination of the like to further indicate orientation and operation. Additionally, the auto-injector may include a viewing window into the interior of the auto-injector for medication inspection, which may further assist the user in establishing orientation.

[0010] In one aspect, the sealed housing consists of two components, a top and a bottom, which fit together. A drug reservoir containing a drug, a drug dispensing system (MDS), and a needle extension system (NES) are located inside the sealed housing. The bottom half embodiment can provide an opening for the injection needle to pass through. The two halves are geometrically shaped so that they can position and secure the internal components. The two halves that make up the sealed housing can provide a mechanism or interface for rotating the housing relative to the cover. In some embodiments, the sealed housing can assist in determining the locking locations for the MDS and NES, as well as assist in the release of both systems during injection. In addition, the housing can provide features for determining the angular displacement or rotation of the needle barrel to which the injection needle is attached. The sealed housing can assist in providing alignment during displacement relative to the cover. Furthermore, each of the two halves can provide features to assist in assembly of the two halves and ensure proper internal alignment. The sealed housing can provide a means for restraining or supporting the injection needle. Additionally, the two halves may include or be aligned with an interlock to prevent displacement of the sealing housing relative to the cover once an injection is administered.

[0011] A drug dispensing system (MDS) for dispensing a drug comprises a plunger, a biasing member, a retainer, and a keeper. The biasing member may resemble a mechanical compression spring. The spring may be held in a state of potential energy that is released during injection. The retainer, which displaces the plunger, may constrain and support the spring on one end and have a fixed point on the opposite end. The retainer may be secured in place using a separate locking mechanism that facilitates self-locking or that can be released or unlocked during injection. The keeper may constrain and support the side of the spring opposite the retainer and control the displacement of the retainer relative to the keeper. The displacement of the retainer relative to the keeper is proportional to the volume of drug dispensed. The MDS may further include a dispensing needle coupled to the retainer in constant fluid communication with the injection needle. When the retainer contacts the plunger, the dispensing needle pierces the plunger and communicates with the contained drug, which is therefore also in fluid communication with the injection needle. Upon release, the retaining device further displaces the plunger, pumping the dose out of the reservoir, through the dispensing needle, through the fluid connection, and through the injection needle. Flexible tubing or a combination of rigid and flexible tubing can be used to interconnect the dispensing needle with the injection needle.

[0012] In some embodiments, a needle extension system (NES) can include a curved needle, a needle barrel for supporting the curved needle, a needle barrel guide for aligning the needle barrel and the needle during administration, and a biasing member coupled to the needle barrel for rotating the needle barrel, straightening the curved needle, and unfolding the distal end of the tissue. The biasing member can be a torsion spring. In some embodiments, the axis of rotation of the needle barrel can be substantially perpendicular to the longitudinal axis of the drug reservoir. The NES can include a needle barrel cap or another means for securing or fixing the proximal end of the needle to the barrel. Additionally, the needle barrel cap can assist in securing the flexible tubing to the needle. The barrel cap and / or barrel can provide a means for determining the start and end rotational positions of the needle proportional to the depth of injection. In some embodiments, the needle barrel can be secured using a locking mechanism to maintain the potential energy of the torsion spring while held under load and then released or removed during injection. Additionally, the needle barrel guide can maintain the concentricity of the needle barrel during injection. The step of triggering deployment of the curved needle through the opening in the housing can include manually compressing the auto-injector when the housing is aligned with the cover for injection for rotation of the needle barrel to drive the distal end of the curved needle through the opening. Advantageously, the step of retracting the distal end of the needle through the opening results from releasing the manual compression of the auto-injector. Following the injection, displacement of the sealed housing relative to the cover can activate an interlock, preventing further reuse of the auto-injector.

[0013] In certain embodiments, the housing is protected by a cover that provides protection for the sealed housing during storage of the automatic injector. The cover may also provide a means of constraining and supporting the sealed housing so that it is displaced relative to the cover in a controlled manner. In various embodiments, a biasing member facilitates this displacement of the housing relative to the cover. The biasing member may be a spring integrally formed with the cover or the sealed housing, or conversely, a separate component that may be disposed between the sealed housing and the cover. The cover may act or function as a trigger mechanism for the injection. In addition to acting or functioning as protection and a trigger mechanism, the cover may also provide a stable base or platform for performing the injection. The injection-contact surface of the cover may provide a tactile surface that may facilitate the following functionality: providing a stabilizing base for the automatic injector during injection, assisting the user in establishing orientation, and attaching the automatic injector to the injection site through an adhesive layer or other attachment means. Additionally, the constraining support of the sealed housing by the cover may serve as a means of alignment during injection. When the sealing housing is displaced relative to the cover to perform an injection, the cover will maintain alignment and release the MDS and NES during manual compression of the automatic injector from the armed position to the injection position. Manual compression of the sealing housing during injection reduces the overall height of the automatic injector and brings the sealing housing into contact with the intended trigger or protrusion on the cover. Contact with the trigger or protrusion between the cover and the sealing housing during injection may release energy stored in the biasing member, resulting in both needle deployment and medication dispensing, due to the user's compression of the automatic injector. Compressing the sealing housing against the cover causes the distal end of the needle to protrude through the opening and beyond the cover, dispensing the desired dose. In some embodiments, the cover can serve as a means to straighten the needle and provide a backing to support the needle during injection. In this way, the length of the needle deployed into tissue may be straight and perpendicular to the injection surface. Additionally, the cover can guide the sealing housing during manual compression, providing a means to assist in alignment between the two components and ensure proper release of the MDS and NES.Upon releasing the applied compressive force, the biasing member displaces the sealing housing relative to the cover, increasing the height of the automatic injector and retracting the distal end of the needle, hiding the needle and protecting the user from accidental needlesticks. Advantageously, the automatic injector can include an interlocking device for preventing subsequent manual compression of the automatic injector, thereby rendering the automatic injector single-use. The interlocking device can be a contact structure within the housing and the cover. The method described above includes the steps of triggering deployment of a curved injection needle through an opening in the housing, straightening the injection needle and embedding the distal end of the injection needle into tissue at a desired depth, triggering puncture of a medication reservoir with a dispensing needle to provide fluid communication between the reservoir and the curved injection needle, dispensing a dose through the injection needle, and then retracting the distal end of the injection needle.

[0014] In certain embodiments, the auto-injector will be presented with a safety mechanism that is first removed before any subsequent operation. An injection surface is exposed to the user upon removal of the safety mechanism, which may further assist in establishing the auto-injector orientation. The safety mechanism may also provide a means to prevent displacement of the sealing housing relative to the cover prior to removal, so that an injection sequence cannot begin without first removing the mechanism. Alternatively, or in addition, the safety mechanism may remove a protective shroud or sheath that would protect the user from the injection needle in the event of accidental ejection, or perform similar functionality. Thus, removal of the safety mechanism may provide or facilitate the following functionality: establishing the orientation of the auto-injector, providing an interlock to prevent displacement of the sealing housing relative to the cover prior to removal, protecting the user from the injection needle, removing the injection needle or associated or connected components that would further protect the user from the needle, and protecting a tactile coating or surface on the injection-contacting surface of the cover.

[0015] Prior to performing an injection, the injection needle in the NES and the dispensing needle in the MDS can be covered or sealed to maintain a predetermined standard of cleanliness during storage of the auto-injector. Subsequently, one embodiment of the auto-injector can use a needle sheath to provide protection for the user from the distal end of the injection needle. The needle sheath can completely encase the injection needle and prevent any contamination of the needle prior to use. In one embodiment, the needle sheath is used in conjunction with another component to protect the distal portion of the injection needle, which may become embedded in tissue, from contaminants. The needle sheath can also provide a means to prevent the needle from injuring the user in the event of accidental ejection. In other embodiments, the needle sheath can be secured to a safety mechanism to assist in preventing accidental injection. The needle sheath can provide a means of securing and aid in removal prior to use. In one embodiment, the needle sheath has a snap fit that allows for attachment of the needle sheath to the safety mechanism and aids in removal prior to injection. Alternatively, the needle sheath may serve only to prevent the needle from becoming contaminated, and the safety mechanism may provide protection to the user from accidental ejection of the needle.

[0016] In some embodiments, the auto-injector may have an internal power source to enable certain functionality of the auto-injector during storage, during injection, and after injection. The auto-injector may provide audible instructions for administering the injection. Additionally, connectivity of the auto-injector to an everyday smart device enables additional functionality. The connected smart device may display visual and / or audible instructions for administering the injection. Some embodiments may allow the user to monitor the temperature and location of the auto-injector. Additionally, the connected smart device may allow the user to check whether other auto-injectors are nearby. Additional embodiments may allow the smart device to contact emergency responders or next of kin once an injection has been initiated. Furthermore, information about the auto-injector may be remotely monitored by the manufacturer.

[0017] In one aspect, the present invention relates to a compact, high aspect ratio auto-injector for delivering a drug dose subcutaneously or intramuscularly. The auto-injector can include a housing, a drug dispensing system including a drug reservoir disposed within the housing and adapted to contain a dose, and a needle extension mechanism coupled to the drug reservoir, the needle extension mechanism comprising a curved injection needle adapted to be straightened during needle deployment to facilitate dispensing of the dose by the auto-injector.

[0018] In some embodiments of the above aspects, the housing includes a sealed housing rotatably held within the cover. The housing may also include an interface for receiving user input and facilitating manual rotation of the housing relative to the cover from a first locked position to a second unlocked position. In some cases, the housing, the cover, the label, and / or a component directly visible to the user includes indicia indicating the locked, unlocked, and armed positions. The automatic injector may also include a biasing member such that when the housing is rotated to the unlocked position, the sealed housing is automatically displaced axially relative to the cover, increasing the height of the automatic injector. The biasing member may include a spring integrally formed with the housing and disposed between the housing and the cover. In some cases, the automatic injector also includes an interlocking device such that the housing cannot be rotated relative to the cover or displaced axially relative to the cover without removal of the interlocking device. In some cases, manual compression of the automatic injector in the armed position reduces the height of the automatic injector, straightens and extends the distal end of the needle through the housing, dispenses a dose through the needle, and activates a mechanism that activates the interlocking device. In such a case, upon release of the manual compression, the biasing member may automatically displace the housing axially relative to the cover, increasing the height of the auto-injector and retracting the distal end of the needle into the housing. The auto-injector may also include an interlock for preventing subsequent manual compression of the auto-injector, thereby rendering the auto-injector single-use. The interlock may include contact structures in the housing and the cover.

[0019] In some embodiments of the above aspects, the drug dispensing system can further include a plunger within the drug reservoir that forms a sealed cavity for holding the dose. The drug dispensing system can include a dispensing needle in fluid communication with the injection needle. In some cases, the automatic injector can include a flexible tube that interconnects the dispensing needle with the injection needle. The drug dispensing system can also include a spring, a retaining device, and a locking mechanism such that, when the locking mechanism is released, the spring displaces the retaining device, causing the dispensing needle to pierce the plunger and provide fluid communication with the dose. In some cases, the cover includes a second trigger for releasing the retaining device and the locking mechanism. A spring (e.g., a compression spring) can further displace the plunger through the dispensing needle and out of the vial to the injection needle.

[0020] In some embodiments of the above aspects, the needle extension mechanism can include a needle barrel for supporting the curved needle, a spring (e.g., a torsion spring) coupled to the barrel for rotating the barrel to unwind the curved needle, and a barrel locking mechanism for preventing accidental rotation of the barrel. The cover forms an opening through which the distal end of the needle passes during rotation of the barrel, allowing the needle to straighten. In some cases, releasing the barrel locking mechanism allows the spring to rotate the barrel and deploy the needle. In some cases, the cover includes a first trigger for releasing the needle locking mechanism. The needle extension mechanism can also include a barrel cap for securing the proximal end of the needle to the needle barrel.

[0021] In another aspect, the invention relates to a method of operating a compact, high-aspect ratio auto-injector for delivering a drug dose subcutaneously or intramuscularly. The auto-injector can include a housing, a drug dispensing system including a drug reservoir adapted to contain a dose, and a needle extension mechanism coupled to the drug reservoir, the needle extension mechanism including a curved needle. The method can include triggering deployment of a distal end of the curved needle through an opening in a cover of the housing to straighten the needle, triggering puncture of the drug reservoir to provide fluid communication between the reservoir and the curved needle, dispensing the dose through the needle at a desired injection site, and then retracting the distal end of the needle into the auto-injector.

[0022] In some embodiments of the above aspects, the automatic injector further includes an interlocking device such that the housing cannot be rotated relative to the cover or axially displaced relative to the cover without removing the interlocking device. In some cases, the housing can include a sealed housing rotatably held within the cover, and the method further includes manually rotating the housing relative to the cover from a first locked position to a second unlocked position, where the sealed housing is automatically displaced axially relative to the cover to an armed position and increases the height of the automatic injector. In some cases, the method includes determining the locked, unlocked, and armed positions based on indicia on at least one of the housing, the cover, the label, and a component directly visible to the user. The method can further include adhering the cover to the desired injection site prior to triggering the automatic injector. In some cases, the step of triggering puncturing the drug reservoir includes manually compressing the automatic injector when the automatic injector is in the armed position, which activates a drug dispensing mechanism and triggers puncturing of the plunger in the drug reservoir with the distal end of the dispensing needle. The step of triggering the puncturing of the drug reservoir may further include pumping the dose from the reservoir out to the injection needle.

[0023] In some embodiments of the above aspect, manually compressing the auto-injector when the auto-injector is in the armed position further includes activating a needle extension mechanism to trigger deployment of the curved needle through the opening in the cover. In some cases, activating the needle extension mechanism, including deploying the curved needle through the opening in the cover, further includes rotating the needle barrel to drive the distal end of the curved needle through the opening. In some cases, activating the needle extension mechanism includes deploying the distal end of the curved needle through the opening in the cover and straightening the needle. Retracting the distal end of the needle into the auto-injector can result from releasing the manual compression of the auto-injector. The method can also include removing the auto-injector from the desired injection site after dispensing the dose. The method can also include automatically engaging the auto-injector after needle retraction to prevent reuse of the auto-injector and exposure of the distal end of the needle. The method can also include disposing of the auto-injector after a single use. The present invention provides, for example, the following. (Item 1) 1. A compact, high aspect ratio auto-injector for delivering a drug dose subcutaneously or intramuscularly, said auto-injector comprising: The housing and a drug dispensing system disposed within the housing, the drug dispensing system comprising a drug reservoir adapted to contain the dose; a needle extension mechanism coupled to the drug reservoir; Equipped with The automatic injector, wherein the needle extension mechanism comprises a curved needle, the curved needle adapted to be straightened during needle deployment to facilitate dispensing of the dose by the automatic injector. (Item 2) Item 1, wherein the housing comprises a sealed housing rotatably held within a cover. (Item 3) 3. The automatic injector of claim 2, wherein the housing further comprises an interface for receiving user input, the interface facilitating manual rotation of the housing relative to the cover from a first locked position to a second unlocked position. (Item 4) Item 4. The automatic injector of item 3, wherein at least one of the housing, the cover, the label, and the user-visible component includes indicia indicating the locked position, the unlocked position, and the armed position. (Item 5) Item 4. The automatic injector of item 3, further comprising a biasing member whereby, when the housing is rotated to the unlocked position, the sealing housing is automatically displaced axially relative to the cover, increasing the height of the automatic injector. (Item 6) Item 6. The automatic injector of item 5, wherein the biasing member comprises a spring, the spring being integrally formed with the housing, the spring being integrally formed with the cover, or the spring being disposed between the housing and the cover. (Item 7) Item 6. The automatic injector of item 5, further comprising a linkage whereby the housing cannot be rotated relative to the cover or axially displaced relative to the cover without removal of the linkage. (Item 8) 6. The auto-injector of claim 5, wherein manual compression of the auto-injector in the armed position activates a mechanism that reduces the height of the auto-injector, straightens the distal end of the needle and extends it through the housing, dispenses the dose through the needle, and activates a linkage. (Item 9) Item 9. The automatic injector of item 8, wherein upon release of manual compression, the biasing member automatically displaces the housing axially relative to the cover, increasing the height of the automatic injector and retracting the distal end of the needle into the housing. (Item 10) 10. The auto-injector of claim 9, further comprising an interlocking device that prevents subsequent manual compression of the auto-injector, thereby making the auto-injector single-use. (Item 11) Item 11. The automatic injector of item 10, wherein the interlocking device comprises contact structures within the housing and the cover. (Item 12) Item 10. The automatic injector of item 1, wherein the medication dispensing system further comprises a plunger within the medication reservoir, the plunger forming a sealed cavity for holding the dose. (Item 13) Item 13. The automatic injector of item 12, wherein the medication dispensing system further comprises a dispensing needle in fluid communication with the injection needle. (Item 14) Item 14. The automatic injector according to item 13, further comprising a flexible tube interconnecting the dispensing needle with the injection needle. (Item 15) Item 14. The automatic injector of item 13, wherein the medication dispensing system further comprises a spring, a retaining device, and a locking mechanism, whereby, when the locking mechanism is released, the spring displaces the retaining device, causing the dispensing needle to pierce the plunger and provide fluid communication with the dose. (Item 16) Item 16. The automatic injector of item 15, wherein the cover includes a second trigger for releasing the retaining device and the locking mechanism. (Item 17) Item 16. The automatic injector of item 15, wherein the spring further displaces the plunger, thereby pumping the dose out of the vial, through the dispensing needle, and into the injection needle. (Item 18) Item 16. The automatic injector of item 15, wherein the spring comprises a compression spring. (Item 19) 2. The automatic injector of claim 1, wherein the needle extension mechanism further comprises a needle barrel for supporting the curved needle, a spring coupled to the barrel for rotating the barrel to unwind the curved needle, and a barrel locking mechanism for preventing inadvertent rotation of the barrel. (Item 20) 20. The automatic injector of claim 19, wherein the spring comprises a torsion spring. (Item 21) 20. The automatic injector of claim 19, wherein the cover defines an opening through which the distal end of the needle passes to straighten the needle during rotation of the barrel. (Item 22) 22. The automatic injector of claim 21, wherein release of the barrel locking mechanism allows the spring to rotate the barrel and deploy the needle. (Item 23) 23. The automatic injector of claim 22, wherein the cover includes a first trigger for releasing the needle barrel locking mechanism. (Item 24) 20. The automatic injector of claim 19, wherein the needle extension mechanism further comprises a needle barrel cap for securing the proximal end of the injection needle to the needle barrel. (Item 25) 1. A method of operating a compact, high aspect ratio auto-injector for delivering a drug dose subcutaneously or intramuscularly, the auto-injector comprising: a housing; a drug dispensing system comprising a drug reservoir adapted to contain the dose; and a needle extension mechanism coupled to the drug reservoir, the needle extension mechanism comprising a curved injection needle, the method comprising: triggering deployment of a distal end of a curved needle through an opening in a cover of the housing to straighten the needle; triggering puncture of the drug reservoir to provide fluid communication between the reservoir and the curved injection needle; dispensing the dose through the needle at a desired injection site; thereafter, retracting the distal end of the needle into the automatic injector. A method comprising: (Item 26) 26. The method of claim 25, wherein the automatic injector further comprises a linkage whereby the housing cannot be rotated relative to the cover or axially displaced relative to the cover without removal of the linkage. (Item 27) 26. The method of claim 25, wherein the housing comprises a sealed housing rotatably held within a cover, the method further comprising manually rotating the housing relative to the cover from a first locked position to a second unlocked position, wherein the sealed housing is automatically displaced axially relative to the cover to an armed position, increasing the height of the automatic injector. (Item 28) 28. The method of claim 27, further comprising determining the locked, unlocked, and equipped positions based on indicia on at least one of the housing, the cover, a label, and a component directly visible to the user. (Item 29) 28. The method of claim 27, further comprising adhering the cover to the desired injection site prior to triggering the automatic injector. (Item 30) 26. The method of claim 25, wherein the step of triggering the puncturing of the drug reservoir comprises manually compressing the automatic injector when the automatic injector is in the armed position, the compressing actuating the drug dispensing mechanism and triggering the puncturing of a plunger in the drug reservoir with a distal end of a dispensing needle. (Item 31) 31. The method of claim 30, wherein triggering the puncturing of the drug reservoir further comprises pumping the dose from the reservoir out to the injection needle. (Item 32) 31. The method of claim 30, wherein manually compressing the automatic injector when the automatic injector is in the armed position further comprises activating the needle extension mechanism and triggering deployment of the curved injection needle through the opening in the cover. (Item 33) Item 33. The method of item 32, wherein activating the needle extension mechanism, which includes deploying the curved needle through the opening in the cover, further comprises rotating a needle barrel to drive the distal end of the curved needle through the opening. (Item 34) Item 33. The method of item 32, wherein activating the needle extension mechanism includes deploying the distal end of the curved needle through the opening in the cover to straighten the needle. (Item 35) Item 26. The method of item 25, wherein the step of retracting the distal end of the needle into the automatic injector results from releasing manual compression of the automatic injector. (Item 36) 26. The method of claim 25, further comprising removing the auto-injector from the desired injection site after dispensing the dose. (Item 37) 26. The method of claim 25, further comprising automatically engaging the auto-injector after retraction of the needle to prevent reuse of the auto-injector and exposure of the distal end of the needle. (Item 38) 26. The method of claim 25, further comprising the step of disposing of the auto-injector after a single use. [Brief explanation of the drawings]

[0024] In the drawings, reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the invention are described with reference to the following drawings:

[0025] [Figure 1] FIG. 1 is a comparison of form factor aspect ratios of existing auto-injectors compared to an exemplary high aspect ratio auto-injector, according to various embodiments.

[0026] [Figure 2]FIG. 2 is a depiction of an injection sequence showing a user's input actions with an auto-injector and the subsequent auto-injector output, according to various embodiments.

[0027] [Figure 3] FIG. 3 is a schematic isometric view of an auto-injector in a retracted or locked position, according to various embodiments.

[0028] [Figure 4] FIG. 4 is a schematic side view of an auto-injector in a retracted or locked position, according to various embodiments.

[0029] [Figure 5] FIG. 5 is a schematic isometric exploded view of the interior of an auto-injector, according to various embodiments.

[0030] [Figure 6] FIG. 6 is a schematic side exploded view of the interior of an auto-injector, according to various embodiments.

[0031] [Figure 7] 7-11 are schematic side views of successive steps in performing an injection, according to various embodiments (eg, as depicted in FIG. 2). [Figure 8] 7-11 are schematic side views of successive steps in performing an injection, according to various embodiments (eg, as depicted in FIG. 2). [Figure 9] 7-11 are schematic side views of successive steps in performing an injection, according to various embodiments (eg, as depicted in FIG. 2). [Figure 10] 7-11 are schematic side views of successive steps in performing an injection, according to various embodiments (eg, as depicted in FIG. 2). [Figure 11] 7-11 are schematic side views of successive steps in performing an injection, according to various embodiments (eg, as depicted in FIG. 2).

[0032] [Figure 12] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 13] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 14] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 15] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 16] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 17] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 18] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 19] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 20] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 21] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 22] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 23] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 24]12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 25] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 26] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 27] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 28] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 29] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 30] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 31] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 32] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 33] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 34] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 35] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 36] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 37] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 38] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 39] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 40] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 41] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 42] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 43] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 44] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 45] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 46] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 47] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 48] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 49]12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 50] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 51] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 52] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 53] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 54] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 55] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 56] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 57] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 58] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 59] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 60] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 61] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 62] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 63] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 64] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 65] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 66] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 67] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 68] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 69] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 70] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 71] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 72] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 73] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 74]12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 75] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 76] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 77] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 78] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 79] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 80] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 81] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 82] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 83] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 84] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 85] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 86] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 87] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 88] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 89] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 90] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 91] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 92] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 93] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 94] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 95] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 96] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 97] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 98] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 99]12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 100] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 101] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 102] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 103] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 104] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 105] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 106] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 107] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 108] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 109] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 110] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 111] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 112] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 113] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 114] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 115] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 116] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 117] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 118] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 119] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 120] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 121] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 122] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 123] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 124]12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 125] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 126] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 127] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 128] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 129] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 130] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 131] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 132] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 133] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 134] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 135] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 136] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 137] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 138] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 139] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments. [Figure 140] 12-140 are schematic diagrams of various system assemblies and components of an auto-injector, according to various embodiments.

[0033] [Figure 141] FIG. 141 is a chart listing exemplary ranges of values ​​for certain parameters of an auto-injector, according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0034] A first embodiment of the auto-injector 1 is described below. Exemplary user interactions and inputs with the auto-injector 1 are described first, followed by exemplary internal mechanisms of the components of the auto-injector 1 and their interactions.

[0035] To assist the user in performing the proper dose, the auto-injector 1 should be properly oriented during injection. The auto-injector 1 may assist in orientation using markings, tactile surfaces, material color or transparency, and / or other indicia to indicate the selected side. Furthermore, the auto-injector 1 may provide itself with a rotation aid MC-301 (see, e.g., FIG. 29 ), which may be contoured, textured, coated (or a combination of the like) to further indicate orientation and operation. Additionally, the auto-injector 1 may include a viewing window into the interior of the auto-injector 1 for medication inspection, which may further assist the user in establishing proper orientation.

[0036] In certain embodiments, the auto-injector 1 includes a safety mechanism SS-200 (see, e.g., FIGS. 3-7) that must first be removed before any subsequent operation. An injection surface MC-121 (see, e.g., FIG. 17) is exposed to the user upon removal of the safety mechanism SS-200 and may further assist in establishing proper orientation. The safety mechanism SS-200 may also provide a means to prevent displacement of the sealed housing MC-200, MC-300 (see, e.g., FIGS. 3-6) relative to the cover MC-100 (see, e.g., FIGS. 3-6) prior to removal, so that an injection sequence may not begin without first removing the mechanism SS-200. Alternatively, or in addition, the safety mechanism SS-200 may protect the user from the injection needle NES-700 (see, e.g., FIG. 65) in the event of accidental ejection or upon removal of a protective shroud or sheath NES-100 (see, e.g., FIGS. 38-40), which serves similar functionality. Thus, removal of safety mechanism SS-200 may provide or facilitate the following functionality: establishing the orientation of the auto-injector 1; providing an interlock SS-204 (see, e.g., Figures 101-102) to prevent displacement of the sealing housing MC-200, MC-300 relative to the cover MC-100 prior to removal; protecting the user from the needle NES-700; removing an associated or connected component NES-100 that further protects the needle NES-700 or would further protect the user from the needle NES-700; and protecting a tactile coating or surface on the injection contact surface MC-121 of the cover MC-100 (see, e.g., Figure 17).

[0037] In various embodiments, in addition to the internal components disclosed below, the auto-injector 1 includes two main parts, a sealed housing MC-200, MC-300, which is rotatably held within a cup-shaped cover MC-100, which also forms the bottom or injection contact surface MC-121. The sealed housing MC-200, MC-300 is made from an upper MC-300 half and a lower MC-200 half, which are joined together through ultrasonic welding or an alternative means that provides sufficient adhesion or strength. In some embodiments, the bond between the upper MC-300 half and the lower MC-200 half can be such that it is an airtight seal. Additionally, the housing MC-200, MC-300, or one of the subsequent halves comprising the housing MC-200, MC-300, may include tabs MC-210 (see, e.g., FIG. 12), which are molded or formed protrusions that guide and restrain the housing MC-200, MC-300 within the cover MC-100 during operation. The sealed housing MC-200, MC-300 serves as the primary interface for the user to perform the subsequent injection. The two halves that form the sealed housing are geometrically shaped such that they can position and secure the internal components (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).

[0038] The cover MC-100 provides a protective shroud around the housings MC-200, MC-300 and supports the housings for rotation. In some embodiments, the first step in performing or initiating an injection is removing the safety mechanism SS-200. The next step may be placing the injection contact surface MC-121 of the cover MC-100 in place. As previously described, the safety mechanism SS-200 may assist the user in establishing the overall orientation of the auto-injector 1, and thus, upon removal of the safety mechanism SS-200, the injection contact surface MC-121 of the cover MC-100 is exposed, which may further establish this orientation. The injection contact surface MC-121 of the cover MC-100 may provide a tactile surface that may facilitate the following functionality: providing a stabilizing base for the auto-injector 1 during injection, assisting the user in establishing orientation, and / or attaching the auto-injector 1 to the injection site through adhesive or other attachment means.

[0039] In various embodiments, the cover MC-100 has a spring SS-300 (see, e.g., FIGS. 5-6) disposed or formed therein to bias the housings MC-200, MC-300 away from the cover MC-100 during activation and facilitate use. The side walls of the cover MC-100 may include channels, slots, detents, etc. MC-103 (see, e.g., FIG. 15) that correspond to different positions MC-117, MC-118, MC-119, MC-120 (see, e.g., FIG. 18) or tabs or protrusions MC-210 (see, e.g., 21-22) on the side walls of the housings MC-200, MC-300 or positions (e.g., lock, unlock, arm, and inject) that cooperate with such components to maintain alignment and control relative movement between the various positions (e.g., locked, unlocked, armed, and inject). Channels, slots, detents, etc. MC-103 formed in cover MC-100 guide housings MC-200, MC-300 during twisting, expansion, compression, and subsequent expansion of auto-injector 1, facilitating different stages of the injection method and use. Additionally, the cover MC-100 facilitates a means of activating the interlock SS-100 (see, e.g., FIGS. 11-14) so ​​that when the cover MC-100 is in the injection position MC-120 and an injection is initiated, subsequent expansion of the housing MC-200, MC-300 relative to the cover MC-100 prevents double compression of the auto-injector 1, making the auto-injector 1 single-use. The trigger mechanism MC-109 (see, e.g., FIGS. 19-20) is designed so that the interlock SS-100 will always be activated before the MDS or NES to ensure that the sharps injury prevention feature functions even if the injection needle NES-700 is deployed. The cover MC-100 may include formed, molded, or stamped geometric shapes MC-101, MC-102, or indicia to provide orientation of the housing MC-200, MC-300 for assembly or operational control of the auto-injector 1.

[0040] In various embodiments, when the auto-injector 1 is in the storage position MC-117, prior to use, the auto-injector 1 is in a locked position where 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, a user manually rotates the housing MC-200, MC-300 by applying an actuation force to a gripping surface MC-301 (e.g., one or more indentations, protrusions, textures, coatings, or combinations) formed on the top surface MC-300 of the housing MC-200, MC-300. The user-applied force displaces the closed housing MC-200, MC-300 relative to the cover MC-100 from the locked position MC-117 to the unlocked position MC-118. Indicia such as alignment marks on the side walls of the housings MC-200, MC-300 and the cover MC-100 may indicate the different positions (MC-117, MC-118, MC-119, MC-120) of the auto-injector 1. The alignment indicia may also be indicated using labels that are externally visible or other components of the auto-injector 1 (e.g., interlock SS-100). When the housings MC-200, MC-300 are rotated from the locked position MC-117 to the unlocked position MC-118, the housings MC-200, MC-300 are biased away from the cover MC-100 and the auto-injector 1 extends to the armed position MC-119. The extension from the unlocked position MC-118 to the armed position MC-119 is performed automatically using stored potential energy within the biasing member SS-300 such that the user need only apply a motive force to the gripping surface MC-301 to move the auto-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 may be constrained and guided by tabs or protrusions MC-210 on the sealing housing MC-200, MC-300 and channels, slots, detents, etc. MC-103 on the cover MC-100.

[0041] In various embodiments, when the housing MC-200, MC-300 is in the armed position MC-119, tabs or protrusions MC-210 on the housing MC-200, MC-300 and guides on the cover wall MC-103 prevent the housing MC-200, MC-300 from being rotated back to the unlocked position MC-118 and the locked position MC-117. In the armed position MC-119, the auto-injector 1 can only be displaced vertically toward the injection position MC-120. The orientation of the auto-injector 1 is such that the upper side MC-300 faces upward (i.e., away from the injection site) and the flat bottom surface MC-121 of the cover MC-100 faces the injection site. To inject medication, the user applies a normal force perpendicular to the upper MC-300, pushing the sealing housing MC-200, MC-300 into the cover MC-100, initiating the activation sequence of the auto-injector 1 and the injection of medication. The interlock mechanism SS-100 is activated just before the auto-injector 1 reaches the injection position MC-120 so that when the user releases pressure, the interlock SS-100 is engaged and a second injection cannot be attempted. To ensure a full dose, the user maintains force on the sealing housing MC-200, MC-300, maintaining the injection position MC-120 for a predetermined duration, and then releases pressure on the upper MC-300 of the auto-injector 1. Releasing pressure on the sealing housing MC-200, MC-300 allows the sealing housing MC-200, MC-300 to translate relative to the cover MC-100 using the biasing member SS-300, thereby retracting the needle NES-700. In various embodiments, since the interlocks SS-100 have previously activated the MC-109, they will engage themselves while the sealing housings MC-200, MC-300 translate relative to the cover MC-100. After the injection is performed and the interlocks SS-100 engage the trigger mechanism MC-109, a force that is at least twice the injection force on the sealing housings MC-200, MC-300 will not allow the needle NES-700 to be exposed from the injection contact surface MC-121 of the cover MC-100 and can be safely discarded.

[0042] The following list of items (1-11) describes an exemplary activation sequence of the internal components and mechanisms of the auto-injector 1, as well as the interaction of the individual components, according to various embodiments.

[0043] 1.) Before initiating an injection, the user may remove the safety mechanism SS-200 before any subsequent action. Upon removal, the safety mechanism SS-200 exposes the injection surface MC-121 to the user, protecting the injection surface MC-121, which may further assist in establishing proper orientation. The safety mechanism SS-200 may also provide a means (e.g., interlock SS-204) to prevent the sealing housing MC-200, MC-300 from displacing relative to the cover MC-100 prior to removal, so that the injection sequence may not begin without first removing the mechanism SS-200. The safety mechanism SS-200 may also remove the needle sheath NES-100, which protects the user from the injection needle NES-700 in the event of accidental ejection. Additionally, the sheath NES-100, in combination with the barrier NES-600 (see, e.g., Figures 38-40), can cover the needle NES-700 to prevent any possible contamination during storage of the needle NES-700. Thus, during injection, the needle NES-700 is sterile prior to removal of the needle sheath NES-100.

[0044] 2.) Following removal of 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, which causes the sealed housing MC-200, MC-300 to automatically move to the armed position MC-119 by biasing member SS-300. As a result, the housing MC-200, MC-300 translates and rotates a constrained distance and angle. The mechanism that initiates the internal activation sequence inside the sealed housing MC-200, MC-300 when the user applies force to transition the sealed housing MC-200, MC-300 from the armed position MC-119 to the injection position MC-120 is a trigger or protrusion MC-106, MC-107 (see, e.g., Figures 15-16). Activation triggers or protrusions MC-106, MC-107 can be molded or formed on the surface of the cover MC-100. A cavity MC-202 (see, e.g., Figures 22-23) can be molded or formed in the lower half MC-200 of the sealed housing MC-200, MC-300 to allow the sealed housing MC-200, MC-300 and cover MC-100 to rotate and translate relative to one another without interfering with or damaging the activation mechanisms MC-106, MC-107 or alignment mechanisms MC-105 (see, e.g., Figures 19-20). During assembly, activation, and injection, the protrusions or tabs MC-210 molded or formed on the sealing housing MC-200, MC-300 and the corresponding channels, slots, detents, etc. MC-103 on the cover MC-100 may interface and provide sufficient clearance and alignment to prevent damage to the protrusions or triggers MC-105, MC-106, MC-107 on the cover.The cover MC-100 may also have alignment posts or protrusions MC-105 that interface with corresponding cavities MC-211 (see, e.g., FIG. 23) in the sealing housing MC-200, MC-300 during injection (e.g., when the auto-injector 1 is in position MC-120), which may assist in aligning the sealing housing MC-200, MC-300 and the cover MC-100 and direct triggers MC-106, MC-107 on the cover MC-100 with corresponding locking mechanisms NES-500 (see, e.g., FIGS. 38-41), MDS-100 (see, e.g., FIGS. 69-73) located within the sealing housing MC-200, MC-300. 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 assist in maintaining alignment between the sealed housing MC-200, MC-300 and the cover MC-100 during relative movement.

[0045] 3.) When a user applies force to the top surface MC-300 of the seal housing MC-200, MC-300, compressing the seal housing MC-200, MC-300 into the cover MC-100 and performing an injection, the first system to be activated can be the interlock system SS-100. Activating the interlock system SS-100 first ensures that the interlock system SS-100 will always engage the trigger mechanism MC-109 when the user deploys the needle extension system (NES). In some embodiments, the interlock SS-100 is activated by an interference fit between the cover MC-109 and the interlock SS-101 (see, e.g., FIGS. 98-100) when the seal housing MC-200, MC-300 is compressed during an injection. Following injection and release of pressure on the sealing housing MC-200, MC-300, the sealing housing MC-200, MC-300 can be automatically displaced relative to the cover MC-100, and the interlock SS-100 is deployed or engaged. Prior to activation, the interlock SS-100 can be held in a stored state within a cavity MC-201 (see, e.g., FIG. 103), MC-314 (see, e.g., FIGS. 29-34) within the sealing housing MC-200, MC-300.

[0046] 4.) Following activation of the interlock SS-100, the needle extension system (NES) can be activated. The corresponding needle extension trigger or protrusion MC-107 on the cover MC-100 breaks the plane of the enclosure MC-200, MC-300 at a predetermined location MC-203 (see, e.g., FIG. 23) and contacts the NES retainer or locking mechanism NES-500. The NES retainer or locking mechanism NES-500 can retain the potential energy of the biasing member NES-800 (see, e.g., FIGS. 67-68). The biasing member NES-800 can be coupled to the needle barrel NES-200 (see, e.g., FIGS. 46-50) at a predetermined contact point NES-202 (see, e.g., FIGS. 48-50). In one embodiment, the biasing member NES-800 is a torsion spring that rotates the needle barrel NES-200. The retainer or locking mechanism NES-500 can maintain the potential energy of the torsion spring NES-800 through an interference portion NES-201 (see, e.g., FIG. 47) with the needle barrel NES-200. The interface portion NES-501 (see, e.g., FIGs. 60-62) between the needle extension trigger or protrusion MC-107 on the cover MC-100 and the retainer or locking mechanism NES-500 disengages the locking mechanism NES-500 and releases the potential energy stored in the torsion spring NES-800. Release of the torsion spring NES-800 rotates the needle barrel NES-200 and deploys the curved injection needle NES-700. The housing can have an internal geometric portion MC-307 (see, e.g., FIG. 31) to facilitate disengagement of the locking mechanism NES-500 during injection.

[0047] 5.) When the locking mechanism NES-500 disengages from the needle barrel NES-200, the torsion spring NES-800 can rotate the needle barrel NES-200. The needle NES-700 can be secured to and retained within the needle barrel NES-200 by the needle barrel cap NES-300 (see, e.g., Figures 51-54), which mates with a corresponding recess NES-207 formed in the needle barrel NES-200. The needle barrel cap NES-300 can secure the needle NES-700 to the needle barrel NES-200 through a friction fit between elements NES-306 (see, e.g., Figures 53-54) and NES-206 (see, e.g., Figures 46-47). Additionally, the barrel cap NES-300 may secure the flexible tubing NES-900 (see FIG. 40) to the injection needle NES-700 through a friction or compression fit formed by elements NES-304 (see FIG. 51), NES-305 (see FIG. 51), NES-204 (see FIG. 49), and NES-205 (see FIG. 49). Furthermore, the needle barrel cap NES-300 provides a contact surface NES-301 (see FIG. 52) for limiting the rotation of the needle barrel NES-200 to a specific angle. In various embodiments, the bottom half of the hermetic housing MC-200, MC-300, provides an interface MC-218 (see, e.g., FIGS. 21-22) that contacts the needle barrel cap NES-300 during rotation and limits the angular displacement of the barrel NES-200 to a desired rotation angle proportional to the desired injection depth. The barrel cap NES-300, the seal housing MC-200, and the bottom half MC-200 of the MC-300 cooperate to prevent over-rotation of the injection needle NES-700 and ensure proper injection depth is achieved. The needle barrel NES-200 maintains alignment along its axis of rotation during rotation through guides (e.g., NES-203 (see FIG. 46), NES-303 (see FIG. 51), NES-208 (see FIG. 48)) formed in the seal housing MC-200 and the halves of the MC-300 (e.g., MC-207, MC-312, MC-316, MC-302, MC-310, MC-309, MC-216), as well as the needle barrel guide NES-400 (see FIGS. 55-59).These guides may maintain axial alignment and prevent translation of the needle barrel NES-200 and injection needle NES-700 relative to the sealing housing MC-200, MC-300 during injection. The needle barrel guide NES-400 may also provide a channel NES-401 (see FIG. 55) for constraining, supporting, and guiding the NES locking mechanism NES-500 (see, e.g., FIGS. 60-62) during retraction and injection of the auto-injector 1. In some embodiments, the needle barrel cap NES-300 may be ultrasonically welded (see weld NES-210 (FIG. 49), NES-307 (FIG. 51)) or utilize another means of joining the two components together. Additionally, the NES components of the system may be integrated independently of the housing MC-200, MC-300 during assembly.

[0048] 6.) Upon rotation of the needle NES-700, the curved distal end NES-701 (see FIGS. 65-66) of the needle passes through an opening MC-204 (see FIG. 23) formed in the lower half of the hermetic housing MC-200, MC-300 and contacts the needle guide MC-110 (see FIG. 19) on the cover MC-100 such that a portion of the curved needle NES-700 is straightened during unwinding. The location where the needle NES-700 contacts surfaces MC-112, MC-113 (see FIG. 19) on the needle guide MC-110 can be such that the distal end NES-701 (e.g., lancet) does not contact the guide MC-110 to reduce the possibility of scratching or rubbing the needle guide MC-110 and to reduce the possibility of generating residue. In addition to the needle guide MC-110, the sealed housing MC-200, MC-300 may provide a brace MC-309 (see Figures 31-34) to further limit the radial displacement possible (relative to the needle shaft) during injection.

[0049] 7.) After the needle barrel locking mechanism NES-500 is disengaged by the first trigger MC-107, further compression of the housing MC-200, MC-300 into the cover MC-100 allows the second trigger MC-106 to initiate release of the drug dispensing system (MDS) and deliver the drug. Similar to the NES, the drug dispensing trigger MC-106 contacts the corresponding locking mechanism MDS-100, releasing the locking mechanism MDS-100. The trigger MC-106 contacts the interface portion MDS-101 (see FIG. 74) when the locking mechanism MDS-100 is in place MC-203. The locking mechanism MDS-100 maintains the stored potential energy of the biasing member MDS-700 (see FIG. 72). In one embodiment, biasing member MDS-700 is a compression spring constrained and supported by retainers MDS-400, MDS-300 (see FIGS. 72-73) and keeper MDS-200 (see FIGS. 72-73). Release of fastener or locking mechanism MDS-100 allows retainers MDS-300, MDS-400 to displace relative to keeper MDS-200 and contact plunger MDS-900 (see FIG. 72). After contacting plunger MDS-900, retainers MDS-300, MDS-400 and plunger MDS-900 displace together. The total displacement of the retainer MDS-300, MDS-400, and concomitantly, the plunger MDS-900, is determined by the keeper MDS-200, which may provide an interference or other feature MDS-201 (see FIGS. 78-80), MDS-309 (see FIGS. 81-84), MDS-409 to limit the movement of the retainer MDS-300, MDS-400. Thus, the displacement of the retainer MDS-300, MDS-400 relative to the keeper MDS-200 may be proportional to the amount of medication released from the reservoir MDS-800 (see FIGS. 94-95). Additionally, the housing MC-200, MC-300 may have an internal geometry MC-306 (see FIG. 31) sufficient to assist in disengagement of the retainer or locking mechanism MDS-100 during injection.

[0050] 8.) Upon release of the MDS fixture or locking mechanism MDS-100 (FIG. 74), the retaining device MDS-300, MDS-400 may be displaced and contact the plunger MDS-900 due to the stored potential energy of the compression spring MDS-700. The dispensing needle MDS-600 is coupled to the retaining device MDS-300, MDS-400 and may be in fluid contact with the injection needle NES-700 through flexible tubing NES-900. Furthermore, the dispensing needle MDS-600, like the injection needle NES-700, is protected with a protective barrier MDS-500 to prevent any contamination prior to injection MC-120. Thus, release of the compression spring MDS-700 brings the retainer MDS-300, MDS-400 into contact with the plunger MDS-900, forcing the dispensing needle MDS-600 to pierce both the protective barrier MDS-500 and the plunger MDS-900. Medication is dispensed from the reservoir MDS-800 out of the dispensing needle MDS-600 (see FIG. 91 ) in the opposite direction of movement of the plunger MDS-900. In various embodiments, the retainer MDS-300, MDS-400 consists of two halves (e.g., MDS-300, MDS-400) that are ultrasonically welded together or by an alternative means that provides sufficient adhesion or strength (e.g., with welding MDS-405, MDS-305 (see FIGS. 84, 85)). The retainer halves MDS-300, MDS-400 may secure the dispensing needle MDS-600 through a friction fit (MDS-602, MDS-302, MDS-402 (see FIGS. 82, 84, 91)). Additionally, the retainer halves MDS-300, MDS-400 may secure the flexible tubing NES-900 to the dispensing needle MDS-600 through a friction or compression fit MDS-303, MDS-304, MDS-403, MDS-404 (see FIGS. 83-85) to prevent any possible disengagement during dispensing. When mated together, each half of the holding device MDS-300, MDS-400 may have orientation features MDS-301, MDS-401 (see Figures 83-85) that force proper alignment of the two halves MDS-300, MDS-400 during assembly, which also act to maintain the dispensing needle MDS-600 and tubing NES-900 in proper alignment.To maintain a sealed reservoir MDS-800 and to avoid contaminating the medication, the dispensing needle MDS-600 may only penetrate the protective barrier MDS-500 (see FIGS. 89-90) and the plunger MDS-900 during injection.

[0051] 9.) Both the needle extension and drug dispensing triggers MC-106, MC-107, which actuate the NES and MDS, respectively, may have complementary contoured surfaces to their respective locking mechanisms NES-501 (see FIGS. 60-62), MDS-101 (see FIG. 74) at the contact points to reduce the force required to disengage and limit induced stresses in the triggers MC-106, MC-107. Additionally, via predetermined interaction locations MC-203, the housings MC-200, MC-300 may provide constrained supports MC-219 (see FIG. 26) to limit any possible displacement of the triggers MC-106, MC-107 induced by the disengagement force.

[0052] 10.) The proximal end MDS-604 of the dispensing needle MDS-600 (see FIG. 91) may be fluidly connected to the proximal end NES-703 of the injection needle NES-700 (see FIG. 65) by a length of flexible hose or tubing NES-900. The timing of activation of the NES and MDS may be such that the injection needle NES-700 is implanted in tissue and the drug is dispensed within a specified or predetermined time frame.

[0053] 11.) After injection and release of pressure on the sealing housing MC-200, MC-300 by the user, the sealing housing MC-200, MC-300 may automatically translate relative to the cover MC-100 due to the biasing member SS-300. In some embodiments, the biasing member is a compression spring SS-300. During subsequent expansion of the sealing housing MC-200, MC-300, the interlock SS-100 is removed from their cavity MC-201, MC-314, limiting any relative movement between the sealing housing MC-200, MC-300 and the cover MC-100. The interlock SS-100 prevents the automatic injector 1 from being crushed, thereby preventing subsequent extension of the distal end NES-701 of the needle NES-700 from the cover MC-100. The expansion of the sealing housing MC-200, MC-300 relative to the cover MC-100 may be sufficient to completely withdraw and conceal the needle NES-700 within the auto-injector 1. Additionally, channels, slots, detents, etc. MC-103 in the cover MC-100 and molded or formed tabs or protrusions MC-210 on the sealing housing MC-200, MC-300 may prevent any rotation of the cover MC-100 or sealing housing MC-200, MC-300 relative to one another. The interlock SS-100, which prevents subsequent collapse of the auto-injector 1, and the inability to rotate the cover MC-100 or housing MC-200, MC-300, allows for a means of safe disposal and prevents accidental needle exposure NES-700.

[0054] The following paragraphs describe alternative embodiments of the auto-injector 1, including alternative or complementary configurations and activation sequences of the auto-injector 1.

[0055] In this embodiment, the auto-injector 1 may have an internal power source to enable certain functionality of the auto-injector 1 during storage, during injection, and after injection. The auto-injector 1 may provide audible instructions for administering an injection. Additionally, connectivity of the auto-injector 1 to an everyday smart device enables additional functionality. The connected smart device may display visual and / or audible instructions for administering an injection. Some embodiments may allow a user to monitor the temperature and location of the auto-injector 1. Additionally, the connected smart device may allow a user to see if other auto-injectors 1 are nearby. Additional embodiments may allow the smart device to contact emergency responders or next of kin once an injection has been initiated. Additionally, information about the auto-injector 1 may be remotely monitored by the manufacturer.

[0056] Similar to the embodiments described above, this embodiment can establish the orientation of the auto-injector 1 prior to performing any injection through appropriate ergonomic principles. The auto-injector 1 can present the user with an intuitive interface that leverages existing mental models from everyday use. With respect to the user interface, additional or alternative embodiments would provide the same benefits, with possible variations of the following elements that can assist the user in establishing an orientation prior to performing an injection: geometric shapes or elements 1101 (see FIG. 115), tactile surfaces, markings, markings, and / or coloring.

[0057] In certain embodiments, the auto-injector 1 includes a safety SS-200 that must be removed before any subsequent operation. The injection surface MC-121 is exposed to the user once the safety SS-200 is removed and may further assist in establishing proper orientation. The safety SS-200 may also provide a means to prevent the auto-injector 1 from moving from the locked position 3102 (see FIGS. 110-111) to the unlocked positions 3103, 3104 (see FIGS. 110-111) prior to removal, so that an injection sequence cannot be initiated without first removing the safety SS-200. Alternatively, or in addition, the safety SS-200 may remove a protective shroud or sheath NES-100, which may protect the user from the injection needle 4102 (see FIG. 122) in the event of accidental ejection, or facilitate similar functionality. Thus, removal of safety mechanism SS-200 may provide or facilitate, for example, the following functionality: establishing the orientation of the auto-injector 1, providing interlock SS-204 to prevent rotation of the sealed housing prior to removal, protecting the user from the injection needle 4102, removing the injection needle 4102 or an associated or coupled component NES-100 that would further protect the user from the injection needle 4102, and protecting the tactile coating or surface on the injection contact surface MC-121 of cover 3100 (see Figures 110-111).

[0058] In addition to the internal components disclosed below, the auto-injector 1 includes two main parts, the sealed housing 1100, 2100 (see FIGS. 105-107), which are rotatably held within the cup-shaped cover 3100 and may also form the bottom or injection contact surface MC-121. The sealed housing can be made from an upper half 1100 and a lower half 2100 that are joined together through ultrasonic welding or alternative means that provide sufficient adhesive or bond strength. In some embodiments, the bond between the upper half 1100 and the lower half 2100 halves may form an airtight seal. In some cases, the housing 1100, 2100, or one of the subsequent halves 1100, 2100 comprising the housing 1100, 2100, includes a molded or formed protrusion 2107 (see FIGS. 112-113) that guides and restrains the 1100, 2100 within the cover 3100 during operation. The sealed housing 1100, 2100 can serve as the primary interface for the user to perform the injection. In addition to the optionally sealed housing 1100, 2100, the sealed housing 1100, 2100 can include an additional sealing component MC-215 (see FIG. 26), MC-315 (see FIGS. 31-32), or a composite to completely enclose the housing's internal chamber. This sealed chamber can perform the following functions, for example: providing and maintaining a desired internal cleanliness standard, providing a water-resistant enclosure, and allowing a pressure differential between the internal and external environments. Some embodiments of the auto-injector 1 can maintain the desired internal conditions until the time of injection. The two halves 1100, 2100 that form the sealed housing can have geometries 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 secure internal components.

[0059] The following list of items (1-14) describes another exemplary activation sequence of the internal components and mechanisms of the auto-injector 1, as well as the interaction of the individual components, according to various embodiments.

[0060] 1.) When the user unlocks the housing 1100, 2100 from the cover 3100, the housing 1100, 2100 automatically moves to the deployed position 3103 (see FIGS. 110-111). The housing 1100, 2100 translates and rotates a constrained distance and angle. The mechanism that activates the internal activation sequence inside the sealed housing is a trigger or protrusion MC-106, MC-107 molded or formed on the surface of the cover 3100. Cavities MC-202, MC-211 are molded or formed into the bottom half 2100 of the sealed housing 1100, 2100, allowing the sealed housing and cover 2100 to rotate and translate relative to each other without interfering with or damaging the activation or alignment mechanism. During assembly (see position 3105), activation (see positions 3102, 3103), and injection (see position 3104), the protrusions or tabs 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) may interface and provide sufficient clearance and alignment to prevent damage to the protrusions or triggers MC-106, MC-107 on the cover 3100. Further, the cover 3100 may have alignment posts or protrusions MC-105 that interface with corresponding cavities MC-211 in the sealing housings 1100, 2100 during injection to aid in aligning the sealing housings 1100, 2100 and the cover 3100 and to orient triggers MC-106, MC-107 on the cover 3100 along with corresponding locking mechanisms 5100 (see FIG. 136), 7110 (see FIG. 116) disposed within the sealing housings 1100, 2100. Additionally, the cover 3100 and / or sealing housings 1100, 2100 may include additional features that aid in maintaining alignment between the sealing housings 1100, 2100 and the cover 3100 during relative movement. Automatic expansion can occur due to a spring 3101 (see FIGS. 108-111) disposed or formed therein, biasing the housing 1100, 2100 away from the cover 3100 during activation to facilitate use. In certain embodiments, the housing 1100, 2100 can be returned to the locked position 3102 to maintain the internal sealing properties 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.

[0061] 2.) In certain embodiments, the inner injection needle 4102 is not aligned with the needle opening MC-112 formed in the bottom side of the cover 3100. Thus, if the injection needle 4102 is inadvertently misfired, the sharp distal end of the needle NES-701 will not penetrate through the bottom side of the cover MC-121. The user may verify the positioning of the housing 1100, 2100 relative to the cover 3100 using markings and indicia present on the auto-injector 1.

[0062] 3.) Once the auto-injector 1 is in the unlocked position MC-118 and transitions to the activated position 3103, 3104, the housing 1100, 2100 can rotate freely without interference with the triggers MC-106, MC-107. Prior to manual compression of the auto-injector 1 to facilitate an injection, the housing 1100, 2100 can be reset or returned to the locked position 3102 in the event of accidental movement to the activated position 3103.

[0063] 4.) When housing 1100, 2100 is compressed into cover 3100 and transitions from the loaded position 3104 to the injection position MC-120, triggers or protrusions MC-106, MC-107 on cover 3100 puncture designated locations MC-203 on housing 2100 and contact corresponding locks 5100, 7110, initiating the injection sequence. This allows triggers MC-106, MC-107 to penetrate through the bottom side of lower housing half 2100 without causing any inaccuracies or damaging the structure of triggers MC-106, MC-107. Accordingly, the areas MC-203 penetrated by triggers MC-106, MC-107 may include perforations or other auxiliary MC-219 (e.g., different materials, etc.).

[0064] 5.) When the user compresses the auto-injector 1 and administers the injection, the first trigger MC-107 punctures the lower housing half 2100 and initiates the unwinding of the curved injection needle 4102. The unwinding is initiated by the first trigger MC-107 disengaging the locking mechanism 5100. The first trigger MC-107 punctures the housing and contacts the unwinding locking mechanism 5100. The unwinding locking mechanism 5100 is disengaged by retracting the needle barrel 4100 from its retracted, activated, and armed positions 3102, 3103, 3104 (see FIGS. 125-130). The housing 1100, 2100 may have sufficient internal geometry (see elements MC-306, MC-307 (see FIG. 31 )) to assist in disengaging the locking mechanism 5100, 7110 during injection. Unwinding of the needle 4102 prior to engagement with the first trigger MC-307 may be prevented by the unwinding locking mechanism 5100, preventing the needle barrel 4100 from rotating. The corresponding torsion spring 8100 therefore remains wound and under load. In this embodiment, a portion of the needle 4102 has a helical shape prior to injection and a straightened shape during injection. The helical shape of the needle 4102 allows the auto-injector 1 to maintain a low profile and a high aspect ratio. Additionally, the needle 4102 may be made of a material that will not be damaged during manufacturing or unwinding during injection.

[0065] 6.) When the locking mechanism 5100 disengages from the needle barrel 4100, the torsion spring 8100 allows the needle barrel 4100 to freely rotate at a set angle. The injection needle 4102 can be secured in a retaining device 4103 (see FIG. 122) that mates with a corresponding recess 4112 (see FIGS. 125-126) formed in the needle barrel 4100. As the needle barrel 4100 rotates, a portion of the helical injection needle 4102 unwinds. In this embodiment, the portion of the needle 4102 that was curved prior to injection can be straightened during injection and embedded in the tissue. A pair of opposing ribs 2102 (see FIG. 108), 1104 (see FIGS. 114-115) molded into the upper and lower housing halves 1100 and 2100 keep the needle barrel 4100 in place and properly aligned during rotation, both during unwinding and recoil. Additionally, ribs or housings 4113 (see Figures 125-126), 1104, 2102 that align and guide the needle barrel 4100 may be formed or have a geometry (see elements 1103 (see Figures 114-115), 2103 (see Figure 112)) that allow the injection needle 4102 to be guided and disengaged from the needle barrel 4100.

[0066] 7.) The distal end NES-701 of the helical injection needle 4102 passes through an opening 2111 (see FIGS. 112-113) of similar size to the injection needle 4102 formed in the lower housing half 2100 so that the injection needle 4102 is straightened during unwinding through the opening 2111. Controlling the rotation of the needle barrel 4100 with an interference element 4107 (see FIGS. 125-127) ensures that the barrel 4100 is rotated a desired predetermined number of degrees and that the distal end NES-701 of the needle 4102 is stopped at the desired injection depth.

[0067] 8.) Additionally, as the distal end NES-701 of the needle 4102 exits the lower housing half 2100, it may pass through and puncture a seal covering the opening 2111. The seal acts as a barrier between the interior of the housing 1100, 2100 and the external environment. This seal may be an adhesively attached thin TPE film (e.g., Santoprene® material) that keeps the housing 1100, 2100 sealed. Additionally, this type of seal allows the distal end NES-701 of the needle 4102 to pass through without removing any material, avoiding the plugging effect and partial or complete blockage of the internal lumen or bore of the needle 4102 during injection. The seal may also ensure that a sterile internal environment of the housing is maintained.

[0068] 9.) Once the unwinding rotation of the needle barrel 4100 is complete, the torsion spring 8100 can disengage from the needle barrel 4100. The torsion spring 8100 can disengage from the needle barrel 4100 because the unwinding spring tensioner 4104 (see FIG. 128), which is in contact with both the needle barrel 4100 and the torsion spring 8100, has a torsion spring contact point 4106 (see FIG. 128) and a collared surface 4105 (see FIGS. 129-130) that has a non-circular shape. In one embodiment, the torsion spring contact surface 4114 (see FIGS. 137-138), due to the non-circular collar 4105, causes axial displacement of the torsion spring 8100, allowing the proximal end 8103 (see FIG. 140) of the torsion spring 8100 to rise up and out of the contact point 4106 on the barrel 4100 and disengage from the needle barrel 4100. Disengagement can occur such that the rebound torsion spring 8101 that effects the rebound of the injection needle 4102 on the barrel 4100 does not require rewinding of the unwound torsion spring 8100.

[0069] 10.) After needle barrel locking mechanism 5100 is disengaged by first trigger MC-107, further compression of housing 1100, 2100 into cover 3100 allows second trigger MC-106 to initiate dispensing of medicament. Plunger 7102, associated with reservoir or vial 7100 containing medicament, is urged or driven forward by compression spring 7106, which then dispenses the medicament. Compression spring 7106 is activated when second trigger MC-106 releases retaining device 7101, which constrains and holds spring 7106 in a retracted position. Compression spring 7106 drives retaining device 7101 and then plunger 7102 into vial 7100, forcing the medicament out of vial 7100 through dispensing port 7104.

[0070] 11.) The proximal end NES-703 of the injection needle 4102 is fluidly connected to the dispense port 7104 by a length of flexible hose or tubing NES-900. The timing of the unwinding NES and drug administration MDS is such that the injection NES and drug MDS delivery occur within a short, specified time window (e.g., a few seconds after compression).

[0071] 12.) Once the auto-injector 1 is compressed against the injection site and the injection begins, the individual holds the auto-injector 1 against the injection site for a specified duration. Upon release of pressure on the auto-injector 1 after the specified duration, the needle 4102 begins to rebound. Due to the biasing member 3101, the housing 1100, 2100 automatically expands, which upon expansion releases the third locking mechanism 9100 (see FIGS. 133-134) which in turn activates the rebound torsion spring 8101 (see FIG. 129).

[0072] 13.) While the auto-injector 1 is in the compressed configuration, the recoil torsion spring 8101 can be maintained in a wound state by a separate tensioner 9101 (see FIGS. 131-132) and a retaining device 9100. This recoil spring retaining device 9100 can maintain the tensioned state of the recoil torsion spring 8101 during compression of the auto-injector 1 and injection of a dose. Note that the recoil spring 8101 can be disengaged from the needle barrel 4100 during unwinding of the injection needle 4102. Following expansion, after injection, the recoil spring 8101 can engage with an interference element 4107 of the needle barrel 4100 such that the injection needle 4102 is caused to recoil. This engagement 4107 of the recoil spring 8101 on the needle barrel 4100 is facilitated by axial movement of the needle barrel 4100 during the unwinding process. When the recoil spring 8100 disengages from the needle barrel 4100, to prevent the recoil torsion spring 8101 from unwinding (and prematurely recoil the injection needle 4102), the trigger MC-106 activates the recoil spring retainer 9100 so that full compression of the automatic injector 1 acts as a temporary spring retainer until the automatic injector 1 is extended.

[0073] 14.) When the auto-injector 1 is allowed to extend after the injection is completed, the trigger MC-106 disengages, releasing the tensioner 9101 and allowing the recoil torsion spring 8101 to recoil 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.

[0074] The table below provides the names and brief descriptions of the reference numbers that appear in the figures. [Table 1-1] [Table 1-2] [Table 1-3] [Table 1-4] [Table 1-5] [Table 1-6] [Table 1-7] Each numerical value presented herein is considered to represent an exemplary minimum or maximum value within the range of the corresponding parameter. Thus, when added to a claim, the exemplary value provides explicit support for claiming ranges that may exist above or below the numerical value in accordance with the teachings herein. All values ​​between the minimum and maximum values ​​within each numerical range presented herein (including within the chart shown in Figure 141) are contemplated and expressly supported herein, subject to the number of significant digits expressed within each particular range.

[0075] The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and the use of such terms and expressions is not intended to exclude any equivalents of the features or portions thereof shown and described. Additionally, while certain embodiments of the present invention have been described, it will be apparent to those skilled in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the present invention. The structural features and functions of some embodiments may be arranged in various combinations and permutations, all of which are considered to be within the scope of the disclosed invention. Unless otherwise required, the described steps of the various methods may be performed in any order, and some steps may be performed substantially simultaneously. Therefore, the described embodiments are to be considered in all respects only as illustrative and not restrictive. Furthermore, the configurations described herein are intended to be illustrative and not restrictive in any way. Similarly, while physical illustrations are provided for illustrative purposes, it is not intended to be bound by any particular theory or mechanism or to limit the claims accordingly.

Claims

[Claim 1] The invention described in this specification.

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