Automatic syringes and related methods of use

Abstract

The auto-injector includes a housing and a cartridge located within the housing, the cartridge containing a drug. The auto-injector further includes a fluid conduit that is movable from a retracted configuration to an deployed configuration and configured to deliver the drug from the cartridge to the patient, and a temperature sensor configured to measure the temperature of the drug. A controller is coupled to the temperature sensor and is configured to transmit a first signal to an external device if the temperature sensor detects that the temperature of the drug has risen above a threshold temperature.

Description

Technical Field

[0001] Cross - reference to Related Applications This patent application claims the benefit of 35 U.S.C.§119 to U.S. Provisional Patent Application No. 63 / 508,780, filed on June 16, 2023, and U.S. Provisional Patent Application No. 63 / 551,995, filed on February 9, 2024, each of which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to an auto - injector and related methods of use.

[0003] Introduction In various available auto - injectors, upon activation by the user, the needle is deployed and fluid is delivered from the needle to the user. After completion of fluid delivery, the needle can be stored for user comfort, needle safety, and product aesthetics. However, in many auto - injectors, there is a lack of proper monitoring of the system and patient data. Further, many auto - injectors may lack proper control logic for stopping the injection when appropriate.

Summary of the Invention

[0004] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate various embodiments and, together with the description, serve to explain the principles of the disclosed embodiments and forms.

[0005] Aspects of the present disclosure may be implemented in relation to the embodiments illustrated in the accompanying drawings. These drawings show different aspects of the present disclosure, and where appropriate, similar reference numerals are used to denote similar structures, components, materials, and / or elements in different figures. Various combinations of structures, components, and / or elements other than those specifically shown are contemplated and are within the scope of the present disclosure.

[0006] Furthermore, many embodiments are described and illustrated herein. This disclosure is not limited to a single aspect or embodiment thereof, or any combination and / or substitution of aspects and / or embodiments thereof. Furthermore, each aspect and / or embodiment of this disclosure may be used alone or in combination with one or more other aspects and / or embodiments of this disclosure. For the sake of brevity, certain substitutions and combinations are not discussed and / or illustrated separately herein. In particular, embodiments or embodiments described herein as “exemplary” should not be construed as, for example, preferred or advantageous over other embodiments or embodiments, but rather are intended to reflect or indicate that the embodiment(s) are “exemplary” embodiments. [Brief explanation of the drawing]

[0007] [Figure 1] This is a perspective view of an automatic syringe as an example of the disclosure. [Figure 1A] This is a perspective view of a portion of the housing of an automatic syringe as disclosed in this disclosure. [Figure 1B] This is a perspective view of a portion of the housing of an automatic syringe as disclosed in this disclosure. [Figure 2] This is a bottom view of the automatic syringe according to this disclosure. [Figure 3] This is a side view of an automatic syringe showing an activation switch that extends away from the tissue-facing surface, as disclosed herein. [Figure 3A] This is a cross-sectional view of an autosyringer showing an activation switch extending away from a tissue-facing surface, as disclosed herein. [Figure 3B] This is a cross-sectional view of an automatic syringe showing an activation switch in a partially depressed position, as disclosed herein. [Figure 3C] This is a cross-sectional view of an automatic syringe showing the activation switch in the fully depressed position, as disclosed herein. [Figure 4] This is an exploded view of the automatic syringe as disclosed in this document. [Figure 4A] This is a schematic diagram of the control system for the automatic syringe as disclosed herein. [Figure 4B] Exploded view of an auto-injector according to the present disclosure. [Figure 4C] Perspective view of a housing and a part of an electronic device board according to an aspect of the present disclosure. [Figure 5] Exploded view of a needle mechanism according to the present disclosure. [Figure 5A] Perspective view of a fluid conduit according to the present disclosure. [Figure 5B] Cross-sectional view of a needle of a fluid conduit according to the present disclosure. [Figure 6] Perspective view of the needle mechanism of FIG. 5 in a first position according to the present disclosure. [Figure 7] Side view of the needle mechanism of FIG. 5. [Figure 8] Side view of the needle mechanism of FIG. 5. [Figure 9] Side view of the needle mechanism of FIG. 5. [Figure 10] Side view of the needle mechanism of FIG. 5. [Figure 11] Side view of the needle mechanism of FIG. 5. [Figure 12] Side cross-sectional view of a part of an auto-injector according to the present disclosure. [Figure 13A] Side cross-sectional view of a piercing mechanism according to the present disclosure. [Figure 13B] Side cross-sectional view of an auto-injector according to the present disclosure. [Figure 14] Side cross-sectional view of a piercing mechanism according to the present disclosure. [Figure 15] Side view of a needle insertion switch according to the present disclosure. [Figure 16A] Perspective view of a lock for an auto-injector according to an aspect of the present disclosure. [Figure 16B] Bottom view of an auto-injector and a lock according to the present disclosure. [Figure 16C] Cross-sectional view of an auto-injector and a lock according to the present disclosure. [Figure 16D] Cross-sectional view of an auto-injector and a lock according to the present disclosure. [Figure 16E] Perspective view of a lock for an auto-injector according to an aspect of the present disclosure. [Figure 16F] Side view of a lock for an auto-injector according to an aspect of the present disclosure. [Figure 17] Bottom view of an electronic device substrate for an auto-injector according to the present disclosure. [Figure 17A] Perspective view of an electronic device substrate for an auto-injector according to the present disclosure. [Figure 18] Shows a flowchart of an exemplary method according to the present disclosure. [Figure 19] Shows a flowchart of an exemplary method according to the present disclosure. [Figure 20] Shows a flowchart of an exemplary method according to the present disclosure. [Figure 20A] Shows a graph related to the electrical control of an auto-injector according to the present disclosure. [Figure 20B] Shows a graph related to the electrical control of an auto-injector according to the present disclosure. [Figure 21] Shows a flowchart of an exemplary method according to the present disclosure. [Figure 22] Shows a flowchart of an exemplary method according to the present disclosure. [Figure 23] Shows a flowchart of an exemplary method according to the present disclosure. [Figure 24] Shows a diagram of patient data transmission according to the present disclosure. [Figure 25] Shows a functional block diagram of an auto-injector and a mobile device according to the present disclosure. [Figure 26] Shows different types of data related to an auto-injector according to the present disclosure. [Figure 27] Shows an exemplary method for collecting biometric information according to the present disclosure. [Figure 28] Shows an exemplary method for verifying a patient's identity according to the present disclosure. [Figure 29] Shows an exemplary method for collecting data related to the temperature of a patient's injection site according to the present disclosure. [Figure 30] Shows an exemplary method for notifying a user of excessive swelling at an injection site according to the present disclosure. [Figure 31]This disclosure provides an exemplary method for comparing injection force data of automatic syringes. [Figure 32] This disclosure provides an exemplary method for measuring needle depth data during injection. [Figure 33] This disclosure provides an exemplary method for comparing injection data related to the auto-injector. [Figure 34] This disclosure provides an exemplary method for comparing injection frequency data. [Figure 35] This disclosure provides an exemplary method for comparing temperature data of drugs. [Figure 36] This disclosure illustrates an exemplary method for warming a drug. [Figure 37] This disclosure provides an exemplary method for comparing administration rate data related to auto-injectors. [Figure 38] This disclosure provides an exemplary method for verifying patient compliance with the instructions for use related to the auto-injector. [Figure 39] This disclosure provides an exemplary method for comparing the charge status of the batteries of the auto-injectors. [Figure 40] This disclosure illustrates an exemplary embodiment of an automatic syringe that provides voice feedback. [Figure 41] This disclosure provides an exemplary method for detecting leaks in an automatic syringe. [Figure 42] This disclosure provides an exemplary method for verifying the inventory history of an auto-injector or drug. [Figure 43] This disclosure provides an exemplary method for locating an automatic syringe. [Figure 44] This disclosure provides an exemplary method for correcting an error condition in an automatic syringe. [Figure 45] This disclosure provides an exemplary method for detecting whether an automatic syringe has been tampered with. [Figure 46] This disclosure provides an exemplary method for displaying data related to data collected via an automated syringe. [Figure 47] This disclosure provides an exemplary method for detecting the strength of an adhesive related to an automatic syringe. [Figure 48] This disclosure provides an exemplary method for determining the type and dosage of a drug in an automatic injector. [Figure 49] This disclosure provides exemplary methods to encourage adherence to the drug administration treatment plan. [Figure 50] This disclosure provides exemplary methods for addressing the mental state of patients associated with the administration of drugs using an auto-injector. [Figure 51] This disclosure illustrates an exemplary thermal element in an automatic syringe. [Figure 52] This disclosure illustrates an exemplary thermal element in an automatic syringe. [Modes for carrying out the invention]

[0008] Furthermore, many embodiments are described and illustrated herein. This disclosure is not limited to a single aspect or embodiment thereof, or any combination and / or substitution of aspects and / or embodiments thereof. Each aspect and / or embodiment of this disclosure may be used alone or in combination with one or more other aspects and / or embodiments of this disclosure. For brevity, many combinations and substitutions are not described individually herein.

[0009] In particular, for the sake of simplicity and clarity in the illustrations, specific aspects of the figures illustrate the general structure and / or construction methods of various embodiments. Descriptions and details of well-known features and techniques may be omitted so as not to unnecessarily obscure other features. Elements in the figures are not necessarily drawn to a fixed scale. Dimensions of some features may be exaggerated relative to others to improve the understanding of the exemplary embodiments. For example, a person skilled in the art will understand that section views are not drawn to scale and should not be considered to represent proportional relationships between different components. Section views are provided to help illustrate the various components of the depicted assembly and to show their relative positional relationships.

[0010] Detailed explanation Details of each embodiment of this disclosure shown in the attached drawings are described below. Where possible, the same reference numerals are used throughout the drawings for identical or similar parts. In the following description, relative terms such as “approximately,” “substantially,” and “approximately” indicate a possible variation of ±10% in the stated values.

[0011] As described above, existing auto-injectors can be inadvertently activated if dropped or vibrated. Furthermore, existing auto-injectors may lack proper control logic to stop injection at the appropriate time. These shortcomings can lead to premature drug dispensing, increase the complexity of self-administration of drugs, cause user error, and cause discomfort to the user. Therefore, this disclosure relates to various embodiments of injection devices (e.g., auto-injectors) for self-administration of drugs or other therapeutic agents by users. Specifically, according to certain embodiments, the possibility of inadvertent activation of the auto-injector is reduced, and the auto-injector may further incorporate control logic that improves the operation of the auto-injector and the user experience.

[0012] Further details of the additional auto-injectors described herein can be found in PCT / US2018 / 031077 by Arnott, et al., filed on 4 May 2018 and published as WO2018 / 204779 A1, which is incorporated herein by reference in its entirety. Further details of the additional vial puncturing systems described herein can be found in U.S. Patent No. 10,182,969, filed on 10 March 2016, which is incorporated herein by reference in its entirety.

[0013] Entire system An example of such an auto-injector 2 is shown in Figures 1, 2, and 3. As shown in Figure 1, the auto-injector 2 may include a housing 3 having a tissue engagement surface (e.g., bottom surface) 4 into which the needle can be deployed and retracted. As shown in Figures 1 and 1A, the housing 3 may include a transparent window 50. The transparent window 50 allows an observer to view one or more displays or to see the inside of the auto-injector 2 and its components, such as the primary container and / or the drug contained in the primary container.

[0014] In some embodiments, and as shown in Figure 1, the auto-syringe 2 may include a number of openings 51 configured to facilitate the transmission of sound (e.g., from a speaker) generated within the housing 3. The auto-syringe 2 may have any suitable dimensions to enable portability and self-wearing by the user. In one example, the auto-syringe 2 may have a length of about 2.98 inches, a width of about 2.07 inches, and a height of about 1.07 inches. However, other suitable values ​​may also be used, for example, a length of about 0.5 inches to about 5.0 inches, a width of about 0.5 inches to about 3.0 inches, and a height of about 0.5 inches to about 2.0 inches.

[0015] The automatic syringe 2 can be oriented around a longitudinal axis 40 (e.g., the X-axis), a transverse axis 42 (e.g., the Y-axis) substantially perpendicular to the longitudinal axis 40, and a longitudinal axis 44 (e.g., the Z-axis) substantially perpendicular to both the longitudinal axis 40 and the transverse axis 42.

[0016] As shown in Figure 1, the adhesive patch 12 can be bonded to the tissue engagement surface 4 to help secure the auto-syringe 2 to the user's body (e.g., skin). The adhesive patch 12 may be formed from cloth or other suitable material and may contain an adhesive. The adhesive may be water-based or solvent-based, and may be, for example, a hot-melt adhesive. Suitable adhesives include acrylic, dextrin, and urethane adhesives, as well as natural and synthetic elastomers. In some examples, the adhesive provided on the patch 12 may begin to function upon contact with the user's skin. In yet another example, the patch 12 may consist of a nonwoven polyester substrate and an acrylic or silicone adhesive. The patch 12 may be bonded to the housing 3 by, for example, double-sided adhesive or by other mechanisms such as ultrasonic welding. The patch 12 may have a length dimension greater than the width of the auto-syringe 2.

[0017] As shown in Figure 2, the auto-injector 2 may include an opening 6 through which the needle can be deployed and retracted. An activation switch 1409 may be located on the tissue engagement surface 4 and configured to activate the auto-injector 2 or to put the auto-injector 2 into "ready" mode. A touch sensor 1410 may also be located on the tissue engagement surface 4 and configured to help the auto-injector 2 controller determine whether the auto-injector 2 is placed on the user's skin (indicating that the auto-injector should fire or deploy the needle) or whether the activation switch 1409 has been improperly activated (indicating that the operation of the auto-injector 2 should be stopped). To facilitate programming of the auto-injector 2, a connection port 13 may also be located on the tissue engagement surface 4.

[0018] The automatic syringe 2 may be configured to operate in three or more stages, for example, including an injection sequence activation stage, an injection stage, and a storage stage, each of which will be described in further detail herein. The injection sequence activation stage, the injection stage, and the storage stage may be collectively referred to as the "injection sequence" herein.

[0019] Referring to Figures 3A, 3B, and 3C, which show a cross-section of the automatic syringe 2, the activation switch 1409 may be a mechanical plunger-type switch. For example, the activation switch 1409 may include a plunger 1450 having a plunger contact surface 1452. The plunger contact surface 1452 may be generally circular (or may have another suitable shape) and may be large enough to be comfortably pressed by soft skin. In some embodiments, the plunger contact surface 1452 may have a diameter or width in the range of about 2 mm to about 10 mm, a diameter in the range of about 4 mm to about 8 mm, or a diameter of about 6 mm. The activation switch 1409 may further include a shaft 1442, a biasing member 1444, a biasing collar 1446, and a plunger flange 1454. The biasing member 1444 may be, for example, a spring and may surround the shaft 1442. The biasing member 1444 is fixed at one end or immobilized by the biasing collar 1446. The plunger flange 1454 may be configured to contact the plunger switch 1448 or to push down the plunger switch 1448. For clarity, the term "activation switch" and / or references to the activation switch 1409 as used herein should be understood to encompass any or all components of the activation switch 1409, including the shaft 1442, the biasing member 1444, the biasing collar 1446, the plunger switch 1448, the plunger 1450, the plunger contact surface 1452, and the plunger flange 1454.

[0020] In the free state, i.e., when the plunger 1450 is not pressed against the user's skin or otherwise pressed, the plunger 1450 may extend outward from the tissue engagement surface 4, as shown in Figure 3A. In the free state, the plunger contact surface 1452 may be at a distance from the tissue engagement surface 4 in the range of approximately 1 mm to approximately 16 mm, approximately 5 mm to approximately 12 mm, or approximately 8.5 mm. In the free state, the biasing member 1444 may bias the plunger 1450 to extend outward from the tissue engagement surface by pressing against the biasing collar 1446. In the free state, the plunger flange 1454 contacts or pushes down the plunger switch 1448. When the plunger flange 1454 contacts or pushes down the plunger switch 1448, the electrical circuit associated with the plunger switch 1448 may be completed or closed.

[0021] When the plunger 1450 is pressed against the user's skin or otherwise pushed in, the plunger 1450 may initially transition to a partially pushed-in state, as shown in Figure 3B. In the partially pushed-in state, the biasing member 1444 may be compressed against the biasing collar 1446. The plunger flange 1454 may also be disengaged from contact with the plunger switch 1448 or not push down the plunger switch 1448. If the plunger flange 1454 is separated from, not in contact with, or not pushing down the plunger switch 1448, the electrical circuit associated with the plunger switch 1448 may be disconnected or opened. This configuration allows the automatic syringe 2 to be kept in a reduced power state while the plunger 1450 is pushed in, such as when the automatic syringe 2 is being packaged.

[0022] As shown in Figure 3B, the plunger 1450 does not necessarily move to a fully depressed state (shown in Figure 3C) before the plunger flange 1454 disengages from contact with the plunger switch 1448. On the other hand, as shown in Figure 3C, in the fully depressed state, the plunger 1450 may be pushed inward such that the plunger contact surface 1452 is coplanar or nearly coplanar with the tissue engagement surface 4.

[0023] The plunger flange 1454 may disengage from contact with the plunger switch 1448 after, for example, less than 5 mm of movement by the plunger 1450, less than 3 mm of movement by the plunger 1450, less than 1 mm of movement by the plunger 1450, or approximately 0.75 mm of movement by the plunger 1450, all of which occur, for example, when the maximum indentation distance is 8.5 mm. In other words, the plunger 1450 may transition from a free state in which the plunger flange 1454 is in contact with the plunger switch 1448 to a partially indented state in which the plunger flange 1454 is not in contact with the plunger switch 1448, after the plunger 1450 has moved a portion of the maximum indentation distance relative to the housing 3 of the automatic syringe 2. For example, the plunger 1450 may transition to an indented state after moving approximately 5%, 10%, or 20% of the maximum indentation distance. Therefore, the automatic syringe 2 and plunger switch 1448 can adequately respond when the plunger 1450 is pressed against the user's skin. For example, the automatic syringe 2 and plunger switch 1448 can adequately respond when pressed against users with varying skin hardness or varying body fat content. While examples of travel distances for the plunger 1450 are provided herein, it should be understood that this disclosure is not limited to specific examples and any appropriate travel distance may be used.

[0024] The biasing member 1444 may have sufficient rigidity to ensure that the plunger flange 1454 remains in contact with the plunger switch 1448 or continuously pushes down the plunger switch 1448 in the free state. The biasing member 1444 may also have sufficient rigidity to ensure that the plunger 1450 is comfortably pushed down when pressed against the user's skin. The biasing member 1444 can bias the plunger 1450 to maintain the free state.

[0025] Although the activation switch 1409 is shown as a mechanical plunger switch in Figures 3A-3C, it should be understood that the activation switch 1409 may be any other suitable type of switch, such as a rocker switch, optical switch, slow switch, toggle switch, or temperature switch. Furthermore, although the electrical circuit associated with the plunger switch 1448 is described herein as being closed when the plunger 1450 is in a free state and open when the plunger 1450 is in a pressed state, it should be understood that the reverse configuration may be used. For example, the electrical circuit associated with the plunger switch 1448 may be open when the plunger 1450 is in a free state and closed when the plunger 1450 is in a pressed state. In addition, or alternatively, the activation switch 1409 may take the form of an integrated switch or include an integrated switch. For example, the plunger may include a conductive portion that closes the circuit when the conductive portion contacts the circuit board (e.g., the first electronic circuit board 1402) and / or electrical contacts mounted on or on the circuit board.

[0026] The method for controlling the automatic syringe 2 according to the position of the activation switch 1409 will be described in more detail below with reference to Figure 23.

[0027] Furthermore, as shown in Figure 4B, in some embodiments, the automatic syringe 2 may include multiple LEDs 52. The LEDs 52 may be arranged in a ring configuration or in any other suitable configuration. As will be described in more detail below, light from one or more LEDs 52 can indicate various operating states of the automatic syringe 2.

[0028] Auto-injector housing Referring to Figures 1A and 1B, the housing 3 of the auto-injector 2 may include an upper portion 30. The upper portion 30 may form the part of the housing 3 that faces the tissue engagement surface 4. The upper portion 30 may include a transparent window 50 through which the user can see the contents of the auto-injector 2, including the vial and / or the drug contained in the vial. The transparent window 50 may be positioned on the side of the upper portion 30, as shown in Figure 1, and may be formed to conform to the rounded / curved shape of the upper portion 30. The transparent window 50 may also be a generally rectangular shape with rounded corners.

[0029] The upper portion 30 may also include a plurality of transparent windows 54. The transparent windows 54 may be formed on the upper surface of the upper portion 30 and may be arranged in any suitable configuration, such as a circular, elliptical, rectangular, or linear configuration. The transparent windows 54 may be spaced apart from each other in the circumferential direction, for example. The transparent windows 54 can allow light from one or more LEDs located inside the housing 3 to be visible to the user. As described herein, light from one or more LEDs can indicate various operating states of the auto-injector 2.

[0030] The transparent windows 50 and 54 may be integrally formed as part of the upper portion 30. As shown in Figure 1B, the upper portion 30 may include a transparent portion 500 formed from a transparent material. The transparent portion 500 may be continuous so that the transparent windows 50 and 54 are formed from a single piece of transparent material. Furthermore, the transparent portion 500 may be integrated with the upper portion 30 so that the upper portion 30 including the transparent windows 50 and 54 is manufactured as a single part.

[0031] To form the upper portion 30 as a single part, the upper portion 30 may be manufactured using, for example, a double-shot molding process. Figure 19 shows an exemplary method 1900 for molding the upper portion 30 using double-shot molding or insert molding. In step 1910, a first material may be introduced into a first mold having a first core and a first mold cavity. The first material may be a transparent material with low opacity, for example, for transparent windows 50 and 54. The first material may be, for example, transparent acrylic, transparent acrylonitrile butadiene styrene (ABS), polycarbonate, polyvinyl chloride (PVC), or polyethylene terephthalate glycol (PETG). The first mold may be configured to form, for example, the transparent portion 500.

[0032] In step 1920, the material in the first core and the first mold cavity may be moved within the second mold cavity to form the second mold. As it is moved, the first core may hold the first material. The second mold may be configured to form, for example, an upper portion 30. In step 1930, the second material may be introduced into the second mold cavity containing the first material. The second material may be introduced around the first material and the first core in the unoccupied space of the second mold cavity to form the upper portion 30. The second material may be a highly opaque material such as white plastic. The second material may be, for example, ABS, polycarbonate, ABS-polycarbonate blend, PVC, or PETG.

[0033] Therefore, the generally opaque upper portion 30, including the transparent windows 50 and 54, can be formed from two different materials to form a single part. By forming the upper portion 30 as a single part, the overall number of steps required to assemble the automatic syringe 2 can be reduced. For example, in some embodiments, no fastening or bonding steps or materials are required to join the transparent and opaque portions of the housing. By avoiding unnecessary assembly steps, the appearance of the decorative surface of the automatic syringe 2 can be further improved. Furthermore, by forming the upper portion 30 as a single part, the overall structural integrity of the automatic syringe 2 can be improved. Furthermore, by forming the upper portion 30 as a single part, sink marks on the decorative surface can be reduced or eliminated.

[0034] needle mechanism Referring to Figures 5 to 11, the needle mechanism 20 includes a carrier 202 that is movable (e.g., slidable) within the housing 3 between a first position (Figure 6) and a second position (Figure 7). The needle mechanism 20 may also include a fluid conduit 300 that is attached to the carrier 202 and can be deployed into the user and retracted by the driver 320. A shuttle 340 (e.g., a shuttle actuator) may be configured to move the driver 320 via a deployment gear 360 and a retraction gear 362. The shuttle 340 may be coupled to an elastic member (e.g., a spring 370). A cover 380 (Figure 5) may be coupled to the carrier 202 so as to surround the various components of the needle mechanism 20.

[0035] Referring to Figure 5, the fluid conduit 300 may extend from a first end 302 to a second end 304. As shown in more detail in Figure 5A, the first end 302 may include a needle 306 configured to be inserted into the user. The needle 306 may include a sharp tip and / or an angled tip and may extend generally along or parallel to the axis 44. The second end 304 may include a needle 308 substantially similar to the needle 306 but which may be positioned within the auto-injector 2 to access a drug to be injected into the user through a cartridge 1302 (shown in Figure 13 and described in more detail below). The fluid conduit 300 may include an intermediate section 310 which includes a first section extending along or parallel to the axis 40 and a second section extending along or parallel to the axis 40. The first and second portions of the intermediate section 310 may be joined by a meandering section 312, which facilitates the bending of the fluid conduit 300 and the movement of the needle 306 along the axis 44 during deployment into and retraction from the user. Although the meandering section 312 is shown, any other suitable shape that allows for bending of the fluid conduit 300, e.g., coiled, curved, or other shapes, is also contemplated. The meandering section 312, or a similar structure, may act as a cantilever when the needle 306 is deployed and / or retracted. The meandering section 312 may also bias the fluid conduit 300 into the deployment configuration shown in Figure 5. Once the needle 308 penetrates the cartridge 1302 and establishes fluid communication with the cartridge 1302 (see, for example, Figure 14), the drug can be delivered from the cartridge 1302 into the user through the needle 308, the intermediate section 310, and the needle 306 (penetrating the user's skin). In some examples, the fluid conduit 300 may consist only of metal or a metal alloy. In other examples, the fluid conduit 300 may be any other suitable material, such as a polymer. The needle 308 and the intermediate section 310 may define a 22 or 23 gauge thin-walled needle, and the needle 306 may be a 27 gauge thin-walled needle. Other needle sizes, such as 6 gauge to 34 gauge, and other needle wall thicknesses, such as normal wall, very thin wall, and ultra-thin wall, may also be available as appropriate. The fluid conduit 300 may reduce the amount of material in contact with the drug, reduce seams and assembly steps, and require less sterilization than conventional devices.

[0036] As shown in Figure 5B, the needle 308 may be configured to include a needle tip 308a and a side port 308b. The side port 308b is in fluid communication with the fluid path 308c, allowing the fluid to enter the fluid conduit 300 through the side of the needle 308 rather than through the tip of the needle 308. The rear wall of the side port 308b may be inclined at an angle θ with respect to the longitudinal axis of the fluid path 308c. In some embodiments, the angle θ may be between about 20° and 60°, between about 30° and 50°, or about 40°. By configuring the needle 308 in this way, the needle 308 can be optimized for puncturing the primary container of the autosynergy 2, which may be a sealed cartridge or vial. The relative positional relationship between the needle tip 308a and the side port 308b allows for puncturing the seal of the primary container without coring or cutting a portion of the seal having an opening to the fluid path 308c. This minimizes or prevents small pieces of coring or cut seals from entering the fluid path 308c.

[0037] Needle 306 may be configured substantially similarly to needle 308, as shown in Figure 5B. Alternatively, in some embodiments, either or both of needles 306 and 308 may be a 3-bevel needle, a 5-bevel needle, or any other suitable type of needle. In some embodiments, either or both of needles 306 and 308 may be a pencil-point needle having a round hole or a hole of any other suitable shape.

[0038] The carrier 202 may be formed from plastic (e.g., injection-molded plastic), metal, metal alloy, etc., and may include a flange 204 having an opening 206, and supports 210 and 212. The carrier 202 may also include an opening 216 from which a needle or other fluid conduit can be deployed. The opening 216 may be a slot recessed from the end face of the carrier 202, or in an alternative embodiment, the entire perimeter of the opening 216 may be defined by the material of the carrier 202. The carrier 202 also includes a driver path 218. The driver path 218 may be a slot in the carrier 202 extending along or parallel to the axis 44. The driver path 218 may be configured to receive a projection of the driver 320, such as a projection 330, which will be described in more detail below. The carrier 202 may also include a shuttle path 220 from which the shuttle 340 can travel, as will be described in more detail below.

[0039] The carrier 202 may also include a fastener 240 configured to engage with the shuttle 340. The fastener 240 may be a cantilever having a fixed end 241 (Figure 8) and a free end 242 (Figure 8). The fastener 240 may include an inclined ramp 243 (Figures 9 and 12) which, when engaged or pushed by a ramp 1500 (described with reference to Figure 12), deflects the fastener 240 about the fixed end 241. In a first position, the free end 242 may prevent or obstruct the movement of the shuttle 340, while in a second configuration, the movement of the shuttle 340 may be permitted. The relationship between the fastener 240 and the shuttle 340 will be described in further detail in this application.

[0040] The driver 320 includes two racks 322 and 324 (shown in Figure 8) that are parallel to each other and positioned on opposing sides of the driver 320. The racks 322 and 324 include teeth and may be configured to engage with the deployment gear 360 and the retraction gear 362, respectively, to drive rotation. The driver 320 may include a lumen 326 (or track, recess, or other suitable structure) (Figure 5) configured to receive the needle 306 of the fluid conduit 300. The driver 320 may also include a projection 330 (Figures 6 and 7) configured to slide within the driver path 218 of the carrier 202. The projection 330 may include a hook-like configuration that can "hook" onto an obstacle 600, as will be described in more detail below.

[0041] Continuing to refer to Figure 5, the shuttle 340 may include a rack 342 configured to engage with gears 360 and 362. The shuttle 340 may also include an end face 344 and a recess 346 extending along the length of the shuttle 340 in the same direction as the rack 342. A slot 348 (Figure 9) may extend along the length of the recess 346. The slot 348 may extend through the center of the recess 346 and may extend along the entire or substantially entire recess 346.

[0042] The shuttle 340 can move along the track 220 from a first starting position (Figure 8) to a second intermediate position (Figures 9 and 10), and from the second position to a third final position (shown between the second and third configurations in Figure 11). As the shuttle 340 moves along the track 220, the rack 342 engages first with the deployment gear 360 and then with the retraction gear 362. At any given time, the rack 342 is always engaged with one or more of the deployment gear 360 and the retraction gear 362. In some examples, such as when the rack 342 is longitudinally positioned between the deployment gear 360 and the retraction gear 362, the rack 342 does not engage with either the deployment gear 360 or the retraction gear 362. The shuttle 340 may be configured to move only along one axis (e.g., axis 40) and only in one direction along that axis. The force required to move the shuttle 340 along the track 220 may be provided by the extension of the spring 370. The spring 370 may be compressed from a stationary state, and the expansion of the spring 370 may move the shuttle 340 along the track 220 through the series of positions / configurations described above. At various positions of the shuttle 340, different features of the automatic syringe 2 may directly or indirectly prevent the movement of the shuttle 340. Alternatively, the spring 370 may be biased into a compressed configuration. In this alternative embodiment, the spring 370 may be expanded from a stationary state, and the compression of the spring 370 may move the shuttle 340 along the track 220 through the series of positions / configurations described above.

[0043] The first position of the shuttle 340 shown in Figure 8 may correspond to the unused, undeployed, and / or new state of the automatic syringe 2. In this first position, the driver 320 may be in an undeployed state. The shuttle 340 is maintained in the first position by positioning an obstacle 600 in the path of the driver 320 (Figure 6). The obstacle 600 may be a shelf of the housing 3 or another suitable blocking device, which can prevent the driver 320 from moving by engaging with and / or holding the projection 330. Thus, since the driver 320, the deployment gear 360, and the rack 342 are coupled to each other, blocking the driver 320 also prevents the shuttle 340 from moving. The shuttle 340 can move from the first position to the second position by moving the obstacle 600 relative to the carrier 202 (or vice versa). In one example, the carrier 202 is moved (e.g., to the left in Figure 6) while the obstacle 600 remains stationary.

[0044] When the path of the driver 320 is free from the obstacle 600 (Figure 7), the spring 370 extends, allowing the shuttle 340 to move along the track 220. This linear motion of the shuttle 340 may cause the deployment gear 360 to rotate counterclockwise (or clockwise in other examples) via the rack 342, and the rotation of the deployment gear 360 may cause the driver 320 to move downward along the axis 44 via the rack 322 of the driver 320. This downward movement of the driver 320 may allow the needle 306 to penetrate the user's skin. In some examples, the driver 320 may be configured to move only along the axis 44 relative to the carrier 202.

[0045] The shuttle 340 can be moved by the expansion of the spring 370 until its end face 344 abuts against the free end 242 of the fastener 240, so that the shuttle 340 is maintained in the second position shown in Figures 9 and 10. At this point, the free end 242 can prevent further expansion of the spring 370 and further movement of the shuttle 340 along the track 220. In this second position, the fluid conduit 300 can be deployed into the user, and fluid from the cartridge 1302 can be injected into the user via the needle 306. Furthermore, while the shuttle 340 is in the second position, the rack 342 can engage with the deployment gear 360 to maintain the needle 306 in the deployed configuration. The shuttle 340 can move from the second position to the third position by the deflection of the fastener 240 around its fixed end 241. Further details of this deflection are described below with respect to Figures 12 to 14. The deflection of the fastener 240 causes the spring 370 to continue expanding, further biasing the shuttle 340 along the track 220. In some examples, as the shuttle 340 moves from a second position to a third position, the fastener 240 is received by and / or within the recess 346 of the shuttle 340, and the ramp 243 can slide within the slot 348.

[0046] The movement of the shuttle 340 from the second position to the third position may correspond to the retraction of the needle 306 from the user into the housing 3. In particular, the rack 342 can be rotated in the same direction (e.g., counterclockwise or clockwise) as the deployment gear 360 is rotated, in engagement with the retraction gear 362. The rotation of the retraction gear 362 may bias the driver 320 back to the retracted position via the rack 324. The shuttle 340 may reach the third position in which the driver 320 is fully retracted when its end face 344 engages with the wall of the carrier 202, when the free end 242 of the fastener 240 reaches the end of the recess 346, and / or when the spring 370 reaches a resting state.

[0047] In some embodiments, once the driver 320 moves from the extended state back to the retracted state, it may be prevented from moving from the retracted state. As a result, the needle 306 is prevented from being redeployed to the user. In this configuration, the auto-syringe 2 may be a single-use device (e.g., discarded after completing one injection). In other embodiments, the auto-syringe 2 may be reset and reused. Furthermore, in some examples, the extension gear 360 and the retraction gear 362 may be the only rotating gear located within the auto-syringe 2. Perforation system and sterilization connector

[0048] Figures 13 and 14 illustrate the features of the puncture system 1300 of the automatic syringe 2. Additional details of the exemplary puncture system can be found in U.S. Patent Application Publication 2016 / 0262984 A1 of Arnott et al., published on September 15, 2016, which is incorporated herein by reference in its entirety. The puncture system 1300 includes a primary container, which may be a cartridge 1302 having a first end 1304 and a second end 1306. Alternatively, the primary container may be a chamber, syringe, vial, flexible pouch, or any other suitable fluid-containing structure.

[0049] The cartridge 1302 may include a cavity 1308 that opens at a first end 1304 and extends toward a second end 1306. The second end 1306 may include a neck 1310, and a cap 1312 engages with the neck 1310 to close the second end 1306. A partition 1314 is positioned between the cartridge 1302 and the cap 1312 to assist in closing the second end 1306 and to allow the needle 308 (e.g., a fixed needle) to be inserted into the cartridge 1302. The cavity 1308 may be closed at the first end 1304 by a piston 1316.

[0050] In some examples, cartridge 1302 may have a capacity of 5 mL, but any other suitable capacity (e.g., 1 mL to 50 mL, or 2 mL to 10 mL, or 3 mL to 6 mL, or 2 mL to 5 mL, or other suitable ranges) may be available depending on the drug to be delivered. In other examples, cartridge 1302 may have a capacity of 1 mL or more, or 2 mL or more, or 3 mL or more, or 4 mL or more, or 5 mL or more, or 10 mL or more, or 15 mL or more. Cartridge 1302 may contain and store the drug for injection to the user and may help maintain the sterility of the drug. Cartridge 1302 may have a neck with a diameter of 13 mm, a length of 45 mm, and an inner diameter of 19.05 mm. These values ​​are merely illustrative, and other suitable dimensions may be used as appropriate. In some examples, cartridge 1302 may be formed using conventional materials and may be shorter than existing devices, which may help the auto-injector 2 remain cost-effective and compact. Cartridge 1302 may be a shortened version of the ISO 10mL cartridge.

[0051] The partition wall 1314 may comprise an uncoated bromobutyl material or other suitable material. The piston 1316 may comprise a fluoropolymer-coated bromobutyl material and may also comprise a conical nose 1316a that helps reduce dead volume in the cartridge 1302. The piston 1316 may comprise one or more rubber materials, among other materials, such as halobutyl (e.g., bromobutyl, chlorobutyl, fluorobutyl) and / or nitrile.

[0052] The drilling system 1300 may also include a top 1354 located at the second end 1306. The top 1354 may include a base 1355 positioned to cover the partition wall 1314 and the opening of the cartridge 1302. The top 1354 may include a chamber 1356 extending away from the piston 1316 from the base 1355. The chamber 1356 includes an opening 1358 that defines and communicates with the cavity 1357. In some embodiments, the top 1354 may be integrated with the partition wall 1314 (e.g., integrated or one-piece structure). In alternative embodiments (not shown), the top 1354 is provided on the fluid conduit 300 or assembled first and not installed directly on / with the cartridge 1302 and / or integrated with the partition wall 1314.

[0053] A portion of the fluid conduit 300, such as the needle 308 and a tube, may extend into the cavity 1357 through the opening 1358 of the chamber 1356, but not through the base 1355 in the pre-operation state. The opening 1358 may be pre-formed or may be formed by the needle 308 penetrating the chamber 1356. The opening 1358 of the chamber 1356 may form a sterile sliding seal around the needle 308 to prevent pathogens or other contaminants from migrating into the cavity 1357. The needle 308 can move relative to the top 1354 without destroying the sterile seal between them. The cavity 1357 may be sterile or aseptic so that the inner surface of the cavity 1357 and the needle 308 are sterilized. In another embodiment, the cavity 1357 may be sterilized after the needle 308 has been inserted into the cavity 1357 through the opening 1358. In an alternative embodiment, instead of the top portion 1354, a spirally flexible (e.g., rubber) bellows or bladder member forms a cavity 1357, allowing for parallel movement of the cartridge 1302 relative to the needle 308 (or vice versa). The flexible member may also seal the needle 308 after sterilization or form a cavity 1354 around the needle 308.

[0054] The piston 1316 may be coupled to a translation mechanism 1366 configured to translate the piston 1316 and the cartridge 1302 toward a second end 1306. The movement of the piston 1316 toward the second end 1306 causes the piston 1316 to act on the contents (e.g., pharmaceuticals, drugs) in the cartridge 1302, ultimately transmitting force to the second end 1306 of the cartridge 1302, moving the cartridge 1302 along the longitudinal axis 40. The translation mechanism 1366 may include a 12 mm motor with a 5-speed gear reducer (360:1). The translation mechanism 1366 may have spring contacts that form an electrical connection with the associated printed circuit board (e.g., a first electronic board 1402). The motor may be configured to produce a torque of approximately 136 mN*m at 36 rpm. These design parameters of the motor are merely illustrative, and any other suitable motor may also be used.

[0055] The translation mechanism 1366 may include a main screw mechanism coupled to a piston 1316 that extends axially during relative rotation around the longitudinal axis 40. This telescopic main screw may have a 7° / 45° serrated screw shape with an output of 100N, a stroke of 20mm, and a pitch of 0.75mm. Materials for the main screw mechanism may include acetal and polybutylene terephthalate. The main screw mechanism may extend into the piston 1316 to reduce dead space behind the piston 1316. Figures 13 and 14 show a piston 1316 with longitudinally spaced threads, but in some examples, such threads may not be present. In another exemplary embodiment (not shown), the translation mechanism 1366 may include a manually engageable surface or member that is manually operated by a user to move the piston 1316. For example, the drilling system 1300 may include a cartridge or plunger coupled to the back of the piston 1316. In another exemplary embodiment (not shown), the translation mechanism 1366 may include a pneumatically or hydraulically driven member that is operated or started by a user to move the piston 1316. The driving member may be, for example, an expansion bellows, an expansion bladder, an expansion diaphragm, or a sliding seal or piston. Direct pneumatic or hydraulic pressure may provide the force required to move the piston 1316.

[0056] The drilling system 1300 also includes a collar 1390 coupled to or fixed to the second end 1306. The collar 1390 may include a plurality of circumferentially spaced fingers 1392 that engage with the neck 1310 and surround the neck 1310. The collar 1390 may be fixed to or coupled to the second end 1306. The collar 1390 may include a wall 1390a that extends at least partially around the neck 1310, the opening of the second end 1306, the cap 1312, the partition wall 1314, and / or the top 1354. The wall 1390a of the collar 1390 is positioned radially or laterally outward of the neck 1310 and may extend longitudinally beyond the neck 1310, the cap 1312, and the partition wall 1314.

[0057] In the pre-operation state of the drilling system 1300 shown in Figure 13, the edge 1393 of the collar 1390 may engage with a corresponding radially or laterally extending cam, latch, or actuation part 1394 of the driver retaining member 1395. The retaining member 1395 is slidable relative to the collar 1390. In the pre-operation state or pre-operation configuration shown in Figure 13, the collar 1390 and the retaining member 1395 may be configured such that at least a portion of the cam or actuation part 1394 of the retaining member 1395 is positioned directly behind the retaining part 1399 of the driver 1398, which is slidable within the retaining member 1395. The wall 1391 of the driver 1398 may extend into and through the end cap portion 1396 of the retaining member 1395 into the internal portion of the retaining member 1395, and the retaining part 1399 of the driver 1398 may extend radially outward from the wall 1391. In some embodiments, the wall 1391 of the driver 1398 may be substantially cylindrical, and the retaining portion 1399 of the driver 1398 may be a flange extending around the end of the wall 1391.

[0058] In the pre-operation state of the drilling system 1300, an elastically deformed biasing member or elastic member 1397 may be positioned between the cap portion 1396 of the retaining member 1395 and the retaining portion 1399 of the driver 1398. The biasing member 1397 may exert a force on the driver 1398 in the pre-operation state of the drilling system 1300 acting toward the cartridge 1302. The biasing member 1397 may be any member that is effective in applying a force in the pre-operation state and then releasing such force during operation, as described below with reference to Figure 14. In some embodiments, the biasing member 1397 may be a conical or flat spring.

[0059] The needle 308 of the fluid conduit 300 can be fixed to or coupled to the driver 1398 so that the fluid conduit 300 moves together with the driver 1398. In the pre-operation state of the piercing system 1300, the needle 308 may be positioned within the sterile cavity 1357, but not through the base 1355 of the top 1354, the partition 1314, and / or within the cavity 1308 of the cartridge 1302.

[0060] In some embodiments, instead of the cavity 1357, the needle 308 may be placed inside the plug when the piercing system 1300 is in a pre-operation state. The plug may be a solid plug without holes, cavities, or openings, and may be formed from a first rubber material. The first rubber material may be permeable to sterilization gases, such as ethylene oxide or vaporized hydrogen peroxide. The first rubber material may particularly include one or more of isoprene, ethylene propylene diene monomer (M class) rubber (EPDM), and styrene butadiene. The permeability of the first rubber material to sterilization gases allows the needle 308 to be sterilized before use while it is placed inside the plug. The plug may be molded around the needle 308 so that the needle 308 pierces the plug.

[0061] To move the drilling system 1300 from the pre-operation state shown in Figure 13, the translation mechanism 1366 can be activated to move the piston 1316 toward the second end 1306 and to translate the cartridge 1302 toward the driver 1398 along the longitudinal axis 40. Since the needle 308 is not yet in fluid communication with the cartridge 1302, activating the translation mechanism 1366 applies pressure to the fluid contained within the cartridge 1302, which is then applied to the cartridge 1302 itself. This pressure also causes the edge 1393 to push the working part 1394, deflecting the working part 1394 radially outward. Without the working part 1394 blocking its path, the retaining part 1399 and the needle 308 are moved toward the cartridge 1302 by the expansion of the biasing member 1397. The driver 1398 can be coupled to the flange 204 of the carrier 202, and therefore this movement of the driver 1398 toward the cartridge 1302 can also move the carrier 202 in the same direction. This movement corresponds to the movement of the carrier 202 toward the housing 3 in Figures 6 and 7, which allows the projection 330 to pass through the obstacle 600 and insert the needle 306.

[0062] Furthermore, as the needle 308 moves toward the second end 1306 of the cartridge 1302, the needle 308 penetrates the base 1355 of the top 1354, the partition 1314, and the cavity 1308, establishing fluid communication with the contents of the cartridge 1302. Once the needle 308 is in fluid communication with the cartridge 1302, further movement of the piston 1316 toward the second end 1306 biases the fluid to pass through the needle 308 and the rest of the fluid conduit 300. In some embodiments, the puncture system 1300 may be configured so that, after operation, no more of the needle 308 extends into the cavity 1308 than the portion already placed in the sterile cavity 1357. This may help prevent contamination of the contents of the cartridge 1302 by the non-sterile portion of the needle 308.

[0063] The biasing member 1397 may be configured to expand so that the fluid conduit 300 perforates the top 1354 and / or partition wall 1314 at a high speed, such as at least about 10 mm / second or at least about 40 mm / second. Relatively rapid perforation of the top 1354 and / or partition wall 1314 by the biasing member 1397 may help prevent leakage of the contents of the cavity 1308, which may be under pressure from the piston 1316.

[0064] After the drug has been delivered to the user via the needle 306, the needle 306 may be automatically withdrawn from the user. Referring to Figures 12-14, the parallel movement mechanism 1366 may be operated in reverse mode such that the rotation of the main screw is in the opposite direction compared to the insertion step. This reverse rotation may move the piston 316 back toward the first end 1304 and also move the cartridge 1302 in the opposite direction along the axis 40 (compared to the time between fluid delivery and insertion of the needle 306). The movement of the cartridge 1302 in the opposite direction may press the ramp 1500 (mounted on the wall 1391) in Figure 12 against the ramp 243 of the stopper 240. This deflects the stopper 240 about the fixed end 241 of the stopper 240 in the direction of arrow 240a, allowing the shuttle 340 to move from its second position to its third position and retract the needle 306 as described above. In this way, both the withdrawal and insertion of the needle into the patient can be achieved with a single spring within the device.

[0065] It is further intended that the fluid conduit 300 may be the sole fluid conduit of the auto-injector 2 configured to communicate fluidly with the cartridge 1302. Thus, during normal operation of the auto-injector 2, the drug from the cartridge 1302 can only be delivered to the user through the fluid conduit 300. In addition, the needle 306 may be the sole needle of the auto-injector 2 configured to be delivered into the patient. In this way, the fluid can be delivered from the cartridge 1302 to the patient using a single metal or plastic component.

[0066] Locking component (drop pin) Referring to Figures 16A to 16D, the automatic syringe 2 may include a locking component 1610. As shown in Figure 16A, the locking component 1610 may include a locking portion (e.g., a projection) 1612 having a curved surface 1614, and may further include a cover portion 1616. The cover portion 1616 may be shaped to match the tissue engagement surface 4 of the automatic syringe 2, as shown in Figure 16D. The cover portion 1616 and the tissue engagement surface 4 may be concave to receive an anatomical part 1600 of the user. The anatomical part 1600 may be, for example, the thigh, buttocks, arm, posterior, or any other part of the body suitable for injection. The locking portion 1612 may be connected to the cover portion 1616. In some embodiments, the locking component 1610 may be formed as a single piece such that the locking portion 1612 and the cover portion 1616 are integrally connected. The locking component 1610 may be formed from any suitable rigid or semi-rigid material. The lock component 1610 may be formed from, for example, methyl methacrylate acrylonitrile butadiene styrene (ABS), and may also have a frosted, transparent appearance indicating that the lock component 1610 is disposable.

[0067] As shown in Figures 16B to 16C, the locking component 1610 may be positioned on or adjacent to the tissue engagement surface 4 of the auto-syringe 2 so that the locking portion 1612 can extend into the auto-syringe 2. The locking component 1610 may also be positioned on or adjacent to the liner 12a so that the adhesive patch 12 can be initially covered before use of the auto-syringe 2. The locking component 1610 may be positioned relative to the liner 12a so that, in response to the removal of the liner 12a from the adhesive patch 12, the locking component 1610 can also be removed from the tissue engagement surface 4. The locking portion 1612 may extend into the auto-syringe 2 through a locking opening 1630 formed in the tissue engagement surface 4. When the locking component 1610 is positioned on or adjacent to the tissue engagement surface 4, the cover portion 1616 may be attached to the tissue engagement surface 4 via an adhesive placed between the cover portion 1616 and the tissue engagement surface 4. The locking component 1610 may be positioned on or adjacent to the tissue engagement surface 4 so that it can be selectively removed by the user.

[0068] Referring to Figures 16C to 16D, if the locking component 1610 is positioned on or adjacent to the tissue engagement surface 4, the locking portion 1612 may extend into the automatic syringe 2 to prevent movement of one or more internal mechanisms of the automatic syringe 2. For example, if the locking component 1610 is positioned on or adjacent to the automatic syringe 2, the locking portion 1612 may extend into the automatic syringe 2 to engage with one or more internal components of the automatic syringe 2 to prevent those components from moving and / or operating.

[0069] Referring to Figure 16D, if the locking component 1610 is positioned on or adjacent to the tissue engagement surface 4, the locking portion 1612 may extend into the auto-syringe 2 so as to be positioned within the puncture system 1300. As previously stated herein, the collar 1390 may be coupled to or fixed to the second end 1306 of the cartridge 1302. Also as previously stated herein, when the puncture system 1300 moves from its pre-operational state, the cartridge 1302, and therefore the collar 1390, may move toward the retaining portion 1399 in a direction parallel to the longitudinal axis of the cartridge 1302. When the locking portion 1612 extends into the auto-syringe 2 and is adjacent to the collar 1390, the locking portion 1612 may prevent the cartridge 1302 from moving toward the retaining portion 1399, or prevent the cartridge 1302 and the collar 1390 from applying force to the operating portion 1394. Therefore, even if the motor is operated in some way while the locking part 1612 is in its locked position, fluid communication between the needle 308 and the cartridge 1302 cannot be established, and the needle 306 cannot be deployed outside the housing 3. Furthermore, when in the locked position, the locking part 1612 prevents the cartridge 1302 from moving toward the needle 308, thereby preventing deflection of the operating part 1394, and as a result, preventing the holding part 1399 and the needle 308 from moving toward the cartridge 1302. If the automatic syringe 2 is dropped or subjected to vibration, the locking part 1612 can further prevent the puncture system 1300 from moving from its pre-operation state, and as a result, prevent the cartridge 1302 from being punctured by the needle 308.

[0070] When the locking component 1610 is positioned on or adjacent to the tissue engagement surface 4, the locking component 1610 may further function as a spacer between the user's skin and the tissue engagement surface 4. For example, the locking component 1610 may have a thickness such that the touch sensor 1410, which will be described in more detail below, cannot detect the user's skin, thereby preventing unintentional operation of the automatic injector 2. The locking component 1610 may have a thickness of, for example, about 1 mm to about 5 mm, or about 3 mm.

[0071] Therefore, the locking component 1610 can function as an effective safety mechanism to prevent unintentional operation of the automatic syringe 2. When the locking component 1610 is positioned on or adjacent to the tissue engagement surface 4, the locking component 1612 can prevent the movement of various internal components of the automatic syringe 2. If the automatic syringe 2 is dropped on the floor before use, for example, the locking component 1610 can prevent unintentional puncture of the cartridge 1302 and / or unintentional initiation of the injection sequence. The locking component 1610 can also prevent such movement and / or unintentional initiation of the injection sequence if the automatic syringe 2 is subjected to vibration during transport.

[0072] If the user wishes to use the auto-injector 2 and / or is ready to use it, the user may separate the locking component 1610 from the tissue engagement surface 4, thereby removing the locking portion 1612 from the locking opening 1630. The user may, for example, peel off the cover portion 1616 from the tissue engagement surface 4. Alternatively, the user may peel off the liner 12a from the adhesive patch 12, thereby removing the locking component 1610 from the tissue engagement surface 4. When the locking component 1610 is separated from the tissue engagement surface 4, the curved surface 1614 allows the locking portion 1612 to swing within the locking opening 1630, thereby allowing the locking portion 1612 to be easily removed from the locking opening 1630. With the locking portion 1612 removed from the locking opening 1630, the auto-injector 2 may be ready to be used, for example, so that an injection sequence can be initiated.

[0073] Figures 16E and 16F show the locking component 1610 according to several embodiments. As shown in Figures 16E and 16F, the locking component 1610 may have an increased width (compared to the depiction of the locking component 1610 in Figures 16A-16C) to ensure that the locking component 1610 extends over the touch sensor 1410 when the locking component 1610 is placed on the automatic syringe 2. Furthermore, the locking component 1610 may have a ribbed structure and may include a gap or recess 1618 and a hinge 1620. The gap 1618 may prevent the conduction of a capacitive electric field between the user's skin and the touch sensor 1410 when the automatic syringe 2 is placed near the user with the locking component 1610 in place. The hinge 1620 allows the locking component 1610 to flex when it is detached from the automatic syringe 2. In some embodiments, a removable cover other than and / or separate from the locking component 1610 may extend over and cover the touch sensor 1410 to prevent unintentional skin detection.

[0074] electronic equipment Figure 4A shows the control system 1400 of the automatic syringe 2. The control system 1400 may include components located on the first electronic circuit board 1402 and the second electronic circuit board 1404, as well as a power supply 1406. The first electronic circuit board 1402 may include a controller 1408, a start switch 1409, a touch sensor 1410, a needle insertion switch 1412, and an emitter 1414. The second electronic circuit board 1404 may include a detector 1416, a sound module 1418, a vision module 1420, and a tactile module 1422. Figure 4A shows the sound module 1418, the vision module 1420, and the tactile module 1422 included on the second electronic circuit board 1404, but in some embodiments, one or more of the aforementioned modules may be included on the first electronic circuit board 1402. One or more components of the first electronic circuit board 1402 and the second electronic circuit board 1404 may be operably coupled to a controller 1408 and powered by a power supply 1406. The controller 1408 may also be operably coupled to a translation mechanism 1366 and may be configured to control the operation of the translation mechanism 1366 to initiate and control the insertion and retraction of the needle, as described above. The translation mechanism 1366 may be coupled to the first electronic circuit board 1402 via one or more spring contacts during the final assembly step in which the cartridge 1302 is inserted into the housing 3. As described herein, the translation mechanism 1366 may include a motor, a gear mechanism, and a main screw mechanism.

[0075] Most of the assembly of the auto-injector 2 can be performed, for example, on an assembly line in a manufacturing facility. The two device halves (or parts) can then be shipped to a drug filling facility or a final assembly facility. In fact, the two separate parts 1490 and 1492 do not need to be the same size, as shown in Figure 4B. Once a drug vial, for example, cartridge 1302, is filled with the drug or other pharmaceutical, cartridge 1302 can be assembled together with the rest of the auto-injector 2. For example, the two device halves (parts 1490 and 1492) can be assembled together with the filled drug cartridge 1302. In one example, part 1490 and the translation mechanism 1366 can be snap-fitted into place at the rear of cartridge 1302. Part 1490 may be part of a housing 3 that includes a base or module configured to house the translation mechanism 1366 and its associated electronics. Part 1492 may be part of housing 3 which includes substantially all of the other components described herein, including, for example, the needle mechanism, sterile connector, and puncture mechanism described herein. In this example, the electrical connection of the motor of the translation mechanism 1366 needs to be made while snapping the translation mechanism 1366 into place behind the cartridge 1302 (i.e., during the assembly step in which parts 1490 and 1492, and the cartridge 1302, are combined to form a complete and functional automatic syringe 2). To accommodate such an electrical connection, the drive system of the translation mechanism 1366 may include one or more spring contacts 1494 (see Figure 4C) that contact pads 1495 (see also Figure 4C) on the first electronic circuit board 1402 during assembly. Not shown in Figure 4C, the drive system of the translation mechanism 1366 may include additional spring contacts that may contact additional pads on the first electronic circuit board 1402 during assembly. Such additional spring contacts and additional pads may serve to connect additional components of the translation mechanism 1366, such as a tachometer, motor encoder, or other sensor or device, to the first electronic circuit board 1402. Thus, the connection of the translation mechanism 1366 to the first electronic circuit board 1402 (including the controller 1408) can be made without the use of loose wires or other similar structures.

[0076] Such assembly processes may be relatively simpler than those for simpler devices with relatively more complex final assembly processes (e.g., automatic syringes). As a result, the assembly processes described herein may lead to reductions in labor costs.

[0077] In some embodiments, the automatic syringe 2 may include a single (i.e., only or exactly one) electronic substrate 1710, as shown in Figures 17 and 17A, on which components of the control system 1400 described herein may be arranged. As shown in Figure 17A, the electronic substrate 1710 may include a first substrate segment 1712 and a second substrate segment 1714. The first substrate segment 1712 and the second substrate segment 1714 may be physically and electrically connected via a flexible segment 1716. The flexible segment 1716 may be, for example, a ribbon cable, a flexible conductive substrate, or an equivalent. In some embodiments, the flexible segment 1716 may be formed from a fiberglass board that is machined thin enough to bend and is sometimes called "semi-flex". In some embodiments, the flexible segment 1716 may be formed from a flexible polymer. Flexible polymers can be formed by a process sometimes called "rigid-flex," in which a sandwich of glass fibers, flexible polymer, and glass fibers is initially formed. Subsequently, the first and second portions of glass fibers may be removed, leaving a thin flexible polymer portion.

[0078] The electronic circuit board 1710 may include one or more brackets 1720 for mounting the electronic circuit board 1710 inside the automatic syringe 2 or for securing it in any other way. The first circuit board segment 1712 may further include a notch 1718. The notch 1718 may be positioned such that the first circuit board segment 1712 can be positioned to allow a needle to pass through the notch 1718 when deployed.

[0079] In some embodiments, as described herein, the first substrate segment 1712 may correspond to the first electronic circuit board 1402, and the second substrate segment 1714 may similarly correspond to the second electronic circuit board 1404. By connecting the first substrate segment 1712 and the second substrate segment 1714 via a flexible segment 1716, the first substrate segment 1712 may be positioned adjacent to the tissue engagement surface 4 of the auto-syringe 2, while the second substrate segment 1714 may be positioned on the opposite side of the auto-syringe 2 toward the upper portion 30 of the housing 3. Thus, a single electronic circuit board 1710 can be used to connect components positioned on the tissue engagement surface 4 side and components positioned on the upper portion 30 side. Such a configuration eliminates the need for complex wiring or soldering, and can facilitate the assembly of the auto-syringe 2.

[0080] As shown in Figure 17, the electronic circuit board 1710 may be positioned within the housing 3. The first circuit board segment 1712 may be positioned adjacent to the tissue engagement surface 4, while the second circuit board segment 1714 may be positioned on the opposite side of the automatic syringe 2 (for example, behind the first circuit board segment 1712 in Figure 17). The flexible segment 1716 may be bent or folded in such a position to maintain the connection between the first circuit board segment 1712 and the second circuit board segment 1714.

[0081] The touch sensor 1410 may be incorporated within or on the first substrate segment 1712 of the electronic circuit board 1710. To enable proper detection of the user's skin, the touch sensor 1410 and the first substrate segment 1712 may be positioned in close proximity to the tissue engagement surface 4 of the housing 3. The tissue engagement surface 4 of the housing 3, or a portion of the tissue engagement surface 4 adjacent to the touch sensor 1410, may be thin enough so that a detectable electric field can be formed between the touch sensor 1410 and the user's skin. In some embodiments, the portion of the tissue engagement surface 4 adjacent to the touch sensor 1410 may be less than about 2 mm, about 1 mm, or less than 1 mm. Furthermore, the portion of the tissue engagement surface 4 adjacent to the touch sensor 1410 may be made from a solid material such as plastic. By forming a portion of the tissue engagement surface 4 adjacent to the touch sensor 1410 from a solid material, as opposed to a rib material, a hollow material, or a hollow material, the dielectric constant between the user's skin and the touch sensor 1410 can be optimized for the responsiveness of the touch sensor 1410.

[0082] In addition, the touch sensor 1410 may be positioned within or on the electronic circuit board 1710 so as to be adjacent to or near the opening 6 from which the needle can be deployed. Positioning the touch sensor 1410 adjacent to or near the opening 6 increases the likelihood that the touch sensor 1410 can detect the user's skin when the automatic syringe is properly positioned. Furthermore, the curvature of the tissue engagement surface 4 can reduce the likelihood that the touch sensor 1410 may misinterpret a flat surface, such as a tabletop, as the user's skin by creating a space between the touch sensor 1410 and the flat surface.

[0083] By integrating the touch sensor 1410 into or on the electronic circuit board 1710, the need for one or more wires and / or other circuits connecting the touch sensor 1410 to a separate electronic circuit board can be eliminated. This simplifies the assembly of the automatic syringe 2 and can reduce the cost of the automatic syringe.

[0084] Since the electronic substrate 1710 may be positioned adjacent to the tissue engagement surface 4, the electronic substrate 1710 may include a notch to allow a needle to penetrate the electronic substrate 1710 and subsequently unfold through the opening 6. Furthermore, the electronic substrate 1710 may be positioned so that the touch sensor 1410 is directly adjacent to the opening 6 and there is no gap between the edge of the touch sensor 1410 and the opening 6. Alternatively, the electronic substrate 1710 may be positioned so that a gap exists between the edge of the touch sensor 1410 and the opening 6, and the gap has a maximum width of, for example, 5 mm, 2 mm, or 1 mm.

[0085] The controller 1408 may be configured to receive information from the system and system components described above, process the information according to various algorithms, and generate control signals for controlling the internal mechanisms of the automatic syringe 2, including the translation mechanism 1366. Examples of such algorithms are described below with reference to Figures 18 and 20-23. The processor may receive information from the system and system components, process the information according to various algorithms, and generate information signals that can be directed to the voice module 1418, the visual module 1420, the tactile module 1422, or other indicators, for example, of the second electronic circuit board 1404, to inform the user of system status, component status, treatment status, or any other useful information being monitored by the system. The processor may be a digital IC processor, an analog processor, or any other suitable logic or control system that executes the control algorithms.

[0086] As described above with respect to Figures 3A and 3B, the activation switch 1409 may be a mechanical plunger-type switch extending away from the tissue engagement surface 4 of the auto-injector 2. The activation switch 1409 may include an electrical circuit that is complete unless the activation switch 1409 is pressed. For example, when the auto-injector 2 is attached to the user's skin, the switch 1409 may be pressed, the electrical circuit may be interrupted, and the controller 1408 may be indicated that the auto-injector 2 should be activated. To conserve power, the components of the auto-injector 2 may be in idle or sleep mode until the switch 1409 is activated. In yet another example, the auto-injector 2 may have no power supplied at all until the switch 1409 is activated, and the power to the auto-injector 2 may be completely cut off by the activation or deactivation of the switch 1409. Although a mechanical plunger-type switch is disclosed, any other suitable mechanism for activating the auto-injector 2 may be utilized, including, for example, a button pressed by the user, an audio signal, and a radio signal from another electronic device.

[0087] The touch sensor 1410 may be configured to assist the controller 1408 in determining whether the auto-injector 2 is properly deployed on the user's skin. In one example, the touch sensor 1410 may be a capacitive sensing electrode or any other device configured to distinguish contact between skin and other materials, such as wood, plastic, metal, or another material. When skin is near the capacitive sensing electrode, a signal indicating such contact may be sent to the controller 1408. Thus, the touch sensor 1410 may function to verify that the auto-injector 2 is properly positioned on the user's skin, even when the switch 1409 is pressed. The touch sensor 1410 may include a capacitive sensing electrode coupled inside the first electronic circuit board 1402 and the housing 3. The housing 3 and adhesive patch 12 may function as an overlay (insulator) that acts as a dielectric between the user's skin and the capacitive sensing electrode. Alternatively, the touch sensor 1410 may be incorporated into or on the electronic circuit board 1710, as previously described herein, and as a result, the capacitive sensing electrode may also be incorporated into or on the electronic circuit board 1710. Contact between the housing 3 and / or a portion of the adhesive patch 12 near the capacitive sensing electrode may increase the capacitance of the electrode by, for example, about 1 to about 10 pF, thereby indicating the placement of the auto-injector 2 on the skin surface.

[0088] The needle insertion switch 1412 may be configured to send a signal to the controller 1408 indicating that the needle 306 has been deployed into the user. For example, referring to Figure 15, the needle insertion switch 1412 may include a curved cantilever 1510 including a first contact 1512. The needle insertion switch 1412 may also include a second contact 1514. The first contact 1512 may be positioned to make electrical contact with the second contact 1514 when the needle 306 is deployed into the user. During the deployment of the needle 306, the driver 320 may move downward along the axis 44, deflecting the curved cantilever 1510 and the first contact 1512 toward the second contact 1514. When the first contact 1512 and the second contact 1514 are connected to each other, a signal indicating that the needle 306 has been successfully deployed into the user may be sent to the controller 1408. The separation of the first contact 1512 and the second contact 1514 can indicate that the needle 306 has been retracted away from the user.

[0089] The emitter 1414 and detector 1416 may act as a light-blocking sensor or photointerrupter to enable the controller 1408 to determine the state of the automatic syringe 2. The emitter 1414 may be a light-emitting diode (LED) or other suitable light-emitting element, and the detector 1416 may be a phototransistor configured to receive light emitted by the emitter 1414, for example. In one example, the emitter 1414 may emit infrared light, but other suitable wavelengths of light may be used. The use of infrared light may help reduce interference from external light.

[0090] As shown in Figure 13B, the emitter 1414 and the detector 1416 may be positioned facing each other within the housing 3 so as to allow the light beam 1430 to pass from the emitter 1414 through the cartridge 1302 to the detector 1416. The cartridge 1302 and any fluid contained therein may be at least partially transparent to the beam 1430 so that the beam 1430 can pass through the cartridge 1302 and its contents. When the piston 1316 is moved toward the second end 1306 during drug delivery (see Figures 13 and 14), the piston 1316, in particular the shoulder of the piston 1316, may block the beam 1430. When the detector 1416 is unable to detect the beam 1430, a signal may be transmitted to the controller 1408, which may interpret the signal as indicating the end of the injection (e.g., that all of the drug contained in the cartridge 1302 has been discharged). In some examples, the refraction path of the beam 1430 may be considered when positioning the emitter 1414 and detector 1416 relative to each other. For example, since the beam 1430 may be refracted as it passes through the cartridge 1302 and any liquid contained therein, the emitter 1414 and detector 1416 may be offset from each other as appropriate. In addition, the emitter 1414 and detector 1416 may be offset from the center of the housing 3 so that the shoulder of the piston 1316 can block the beam 1430. In at least some examples, a light-blocking sensor or similar mechanism may help avoid false detections in the event of a drive system failure. That is, a light switch may help the controller 1408 determine with greater accuracy than other mechanisms that injection was not completed.

[0091] The audio module 1418 may include a speaker or the like for providing audio feedback to the user. The opening in the housing 3 may facilitate the transmission of sound from the audio module 1418 to the user. The audio module 1418 may generate tones or other sounds to indicate the start and end of an injection and / or any other benchmark during the injection, such as an error. The visual module 1420 may include one or more LEDs or similar devices for providing visual feedback to the user. The visual module 1420 may include LEDs of different colors to provide various messages to the user. For example, multiple blue LEDs arranged in a ring may be used to show the progress of the injection over time, one or more green LEDs may be used to show the completion of the injection, and a red LED may be used to show an error to the user. Other appropriate colors, combinations, and / or numbers of LEDs may be used in various examples. For example, a combination of red, blue, and purple LEDs may be used. In one configuration, eight LEDs may be arranged in a circle having a diameter of approximately 26.5 mm, or a diameter of approximately 10.0 mm to approximately 40.0 mm. This exemplary quantity and arrangement of LEDs is not intended to be limiting, and it should be understood that any quantity and / or arrangement of LEDs may be used. The LEDs may be activated sequentially around a circle to indicate the progress of the injection (for example, in a progress ring arranged similarly to a clock, see LED 52 in Figure 4B, for example). The controller 1408 may also be configured to receive feedback from various sensors and readjust the speed at which the various LEDs are activated based on the feedback from the sensors. For example, the LEDs in the progress ring may be activated in three or more operating stages, including, for example, the injection sequence activation stage, the injection stage, and the storage stage. Those skilled in the art will recognize that the auto-injector 2 may have more or fewer operating stages than the three described above. While there may be an expected time to complete each stage, there may be some variation in the time actually experienced in any of the aforementioned operating stages of the auto-injector 2.The algorithm can be used, for example, to help avoid premature activation of LEDs if a particular stage finishes earlier than expected, or to halt progress along the ring if a particular stage takes longer than expected. At any given point in time, the algorithm can determine the rate at which the remaining LEDs in the progression ring should be activated by dividing the estimated remaining time until drug delivery is complete by the number of unactivated LEDs in the progression ring.

[0092] For example, before the injection sequence activation phase, the LEDs may be activated at a rate equal to the estimated time for the entire drug delivery process (e.g., the estimated time to complete all phases of the injection sequence activation, injection, and storage) divided by the total number of inactive LEDs in the progress ring. In other words, the estimated time for the entire drug delivery process may be divided by the total number of LEDs in the progress ring minus the number of LEDs that have already been activated. Therefore, for example, if one LED is already activated, the estimated time for the entire drug delivery process may be divided by a number one less than the total number of LEDs in the progress ring.

[0093] After the injection sequence activation phase is complete, the LEDs may be activated at a rate equal to the value obtained by dividing the total estimated time to complete the remaining phases (e.g., injection phase and storage phase) by the number of unlit LEDs in the progression ring. After the injection phase is complete, the LEDs may be activated at a rate equal to the value obtained by dividing the estimated time to complete the storage phase by the number of unlit LEDs.

[0094] In some embodiments, a subset of LEDs can be used to indicate the progress of the injection stage. For example, in an embodiment having eight LEDs arranged on the housing of the automatic syringe 2, the first LED may be illuminated to indicate needle insertion. Then, the second through seventh LEDs can be illuminated sequentially to indicate the progress of the injection stage. Finally, the eighth LED can be illuminated to indicate needle retraction. While exemplary configurations of LEDs and their corresponding logic have been described, it should be understood that the number of LEDs for each stage of the injection process can be changed as desired.

[0095] Furthermore, the visual module 1420 may include a display screen, touchscreen, or other suitable device to provide one-way or two-way communication with the user. The visual module 1420 is visible to the user from outside the housing 3 through a window within the housing 3. The tactile module 1422 may include, for example, a tactile motor configured to produce vibrations that the user can feel. The vibrations may signal the start and end of an injection and / or help provide the user with additional information.

[0096] The controller 1408 may be coupled to a wireless communication module and an antenna. The wireless communication module may be configured to transmit data from the controller 1408 to, for example, a mobile device 1407, a computer, a mobile phone, etc. The mobile device 1407 may include any suitable mobile device, such as a smartphone, laptop, smartwatch, headset, etc. The mobile device 1407 enables the user 1449 to perform tasks such as texting, making calls, and searching the internet. The wireless communication module may be configured to transmit information via one or more wireless modalities, such as, among other things, Bluetooth, Bluetooth low energy (BLE), near-field communication (NFC), infrared, cellular networks, and wireless networks. The antenna may be any suitable device configured to assist the wireless communication module in data transmission and / or amplification. Accordingly, the controller 1408 may be configured to transmit diagnostic information of the user and / or the auto-injector 2, information regarding the completion of injection, and / or information regarding the error status of the auto-injector 2 to the user's device or the cloud. Signals indicating needle insertion and / or early device removal may also be transmitted via the wireless communication module. Furthermore, the controller 1408 may be configured to transmit temperature information of the auto-injector 2. For example, the user can monitor the temperature of the auto-injector 2 via the mobile device 1407 and / or application, for example, when the auto-injector 2 is removed from the refrigerator. The user can also monitor the temperature of the drug inside the auto-injector 2 via the mobile device 1407 and / or application. The mobile device 1407 and / or application may be configured to show the user whether the drug has reached a suitable temperature for administration. In addition, the mobile device 1407 and / or application may be configured to show the user whether the drug has reached a temperature such as an inappropriately high temperature that could impair the drug. The controller 1408 may also receive start commands and / or delay commands via the wireless communication module.The controller 1408 may further receive operation adjustment commands, such as commands relating to adjusting a preferred operating speed. In some embodiments, the controller 1408 may receive commands to increase the injection speed, or commands to decrease the injection speed, or commands to pause the injection.

[0097] In some embodiments, the controller 1408 may communicate with a mobile application on the user's mobile device via a wireless communication module. The mobile application may be configured to facilitate the use of the auto-injector 2 and improve the user experience. In some embodiments, the mobile application may be used to automatically check the expiration date of the medication contained in the auto-injector 2. Such a function may free the user from the need to manually check the expiration date and may improve user safety. Based on the expiration date, the mobile device may be configured to warn the user and / or disable the use of the auto-injector 2. In some embodiments, the mobile application may be used to warn the user regarding product recalls and / or disable the device in the event of a product recall. For example, the mobile application may access a database via the internet to determine whether a particular device, lot of the device, medication, and / or lot of medication has been recalled. In some embodiments, the mobile application may be configured to verify whether the auto-injector 2 and / or medication are genuine and not counterfeit. The mobile application may perform verification, for example, by matching the product serial number or digital signature with a database of authenticated products. In some embodiments, some or more parts of the automatic syringe 2 may be disposable, and the mobile application may be configured to verify the authenticity of such parts before use.

[0098] In some embodiments, a mobile application may be used to facilitate the injection sequence. For example, the mobile application may synchronize with the events of the injection sequence and provide the user with simultaneous instructions on when to perform which task (e.g., pressing down switch 1409, holding auto-injector 2 against the skin, removing auto-injector 2). The mobile application may provide the user 1449 with injection training. In some embodiments, the instructions may be narrated aloud. In some embodiments, the instructions may be provided visually via a display on the mobile device. In some embodiments, the mobile application may be configured to provide a detailed display of the progress of the injection sequence. For example, the mobile application may provide textual, visual, and / or audible instructions of the progress with a finer granularity than that indicated by LEDs, as previously described herein.

[0099] In some embodiments, a mobile application allows a user to control the functions of the auto-injector 2 by providing commands. More specifically, the user may provide commands to the mobile application (provided by one or more input means, including, for example, touch input, keyboard input, stylus input, voice input, or any combination thereof), which are then transmitted to the auto-injector 2. For example, the user may control when to start an injection sequence by providing a start command. As another example, the user may pause an active injection sequence by providing a pause command to the mobile application. In yet another example, the user may issue a command to stop / cancel an injection sequence. In some embodiments, the mobile application may be used to control customizable operating parameters of the auto-injector 2. For example, the user may adjust the needle insertion speed and / or drug dispensing speed via the mobile application. In some embodiments, the user may adjust the needle insertion depth via the mobile application. In some embodiments, the user may enable, disable, and / or personalize visual and audible feedback from the auto-injector 2 via the mobile application.

[0100] In some embodiments, the mobile application may be configured to record and store the date and / or time of injections. Based on the date and / or time of injections, as well as the user's prescription information, the mobile application may be configured to automatically create reminders for subsequent injections. In some embodiments, the mobile application may be configured to receive various types of contextual data related to the user (e.g., schedule information, habit information, etc.) (e.g., at predetermined intervals, in response to predetermined events, etc.). The mobile application may leverage this contextual data to provide reminders at the optimal time (e.g., when contextual data indicates that the user is likely to be at home rather than at the gym). In some embodiments, upon completion of an injection, the mobile application may be configured to provide the user with a notification along with positive feedback on adherence to the prescription plan. In some embodiments, the mobile application may offer points and / or rewards for continued adherence.

[0101] In some embodiments, the mobile application may be configured to authenticate the user of the auto-injector 2 before use. For example, the mobile application may verify the user's identity before injection using biometric authentication, two-factor authentication, or other appropriate authentication protocol in relation to the user's mobile device. Depending on the user's authentication, the mobile application may activate or unlock the auto-injector. Such user authentication can deter misuse and / or waste of expensive medication by someone other than the intended user.

[0102] In some embodiments, the mobile application may be configured to detect the operating status of the auto-syringe 2. For example, the mobile application may be configured to detect the device's battery level, and if a low battery indicator is displayed, the mobile application may be configured to provide the user with a notification indicating the need to charge the device. In some embodiments, the mobile application may be configured to detect mechanical and / or electrical failures of the auto-syringe 2 and to communicate such information to the user. In some embodiments, the mobile application may be informed by the auto-syringe 2 whether a part or cartridge has been inserted incorrectly. The mobile application may then be configured to provide the user with a notification of the incorrect assembly and / or to provide the user with instructions detailing how to properly insert, connect, or position the various components of the auto-syringe 2.

[0103] In one embodiment, the auto-injector 2 may be configured to track data related to various types of errors that may be encountered during use. Non-limiting examples of error-related data include the designation of the type of error identified by the auto-injector 2 (e.g., hardware error, software error, user procedure error, etc.), when the error occurred during the therapeutic administration process (e.g., before, after, during, etc.), the amount of drug delivered despite the error (e.g., no drug, part of the drug including the exact or estimated amount, all of the drug, etc.), and whether the error is correctable (e.g., by the user, by a technician, etc.). In one embodiment, this error data may be stored locally on the device and retrieved later. In another embodiment, the error data may be transmitted (e.g., substantially in real time when the error occurs) to one or more other devices and / or applications (e.g., via a wired or wireless connection). For example, some or all of the error data may be sent to the HCP, which may then log the error data and / or take subsequent steps to rectify the error (e.g., send a notification to the patient's device instructing the patient on how to correct the error, assign a technician or other individual to the patient to rectify the error, or replace the device).

[0104] Data related to administration completion and status may also be tracked. Non-limiting examples of dose-related data include dose delivery rate, total time required for the dose to be fully administered, total time remaining until the current dose is delivered, date the dose was delivered, location the dose was delivered, and / or total amount of dose delivered. Multiple dosing events may be compared to identify similarities and / or differences between events. These comparisons may provide additional contextual information related to device operation and / or user adherence to schedules. For example, if dosing data shows that the dose delivery rate differs from one dosing event to the next, it may suggest a problem with the auto-injector 2 and / or its components. Another example is if dosing data shows that a patient consistently takes their dose while in a monitored environment (e.g., a clinic, hospital) but not consistently takes their dose while at home. In such situations, the patient may be more closely monitored at home to ensure that they are adhering to their prescribed dosing schedule and to ensure optimal results.

[0105] Dosage preparation data can also be tracked to ensure accurate dose delivery to individual patients. For example, general information about each patient's auto-injector can be obtained, for example, by scanning a QR code associated with the patient's auto-injector (e.g., a QR code displayed on a sticker affixed to the outside of the auto-injector). Scanning the QR code (e.g., by a mobile device) can reveal various types of information, such as the auto-injector's serial number, component ID, expiration dates of the components and / or medications contained within it, details of the patient to whom the auto-injector is assigned, and the frequency of administration per prescription. Auto-injector 2 may be configured to track when the last dose was administered and can automatically send instructions to issue a re-prescription to a mobile application and / or a designated device. Auto-injector 2 may also be configured to track device usage data (e.g., medication warm-up time, medication temperature at different points before, after, or during administration, dosage frequency, etc.) and provide that information to the user and / or HCP via a mobile application and / or one or more voice and / or visual prompts integrated with auto-injector 2. If the auto-injector 2 detects a problem and / or error in use (for example, if the patient's dosage is changed or an incorrect prescription is given, or if the patient selects and uses the wrong auto-injector when there are multiple auto-injectors in the home), the auto-injector 2 may be configured to dynamically deactivate to prevent misuse. In addition or alternatively, the auto-injector 2 may transmit a message to a mobile application indicating that a noteworthy error or problem has occurred, which the patient or HCP can then address.

[0106] To further ensure that the correct auto-injector is being used by the appropriate patient, certain safety measures may be put in place. For example, a QR code (e.g., present on a bracelet issued to the patient) may be scanned first (e.g., by the device administrator) to assign the device to the patient. The patient may then be required to have the QR code scanned (e.g., by the auto-injector, or by another device connected to the auto-injector) to confirm that they are authorized to receive treatment. If authorized, the patient may then receive treatment using auto-injector 2. If not authorized, the patient may be prevented from receiving an injection from auto-injector 2. In some embodiments, a temporal element may be present in the scan so that the patient is only eligible to receive treatment within a predetermined time frame. More specifically, if the patient scans the QR code outside of a predetermined time interval, or scans the QR code more than a predetermined number of times within a particular time window (e.g., more than once a day), they may be prevented from receiving treatment.

[0107] Auto-injector 2 may also be configured to track the location on the patient's body where previous injections have been administered, and subsequently provide recommendations regarding new injection sites (e.g., via a mobile application) based on the location of the last injection and / or the patient's medical condition. For example, if a patient has previously received one or more injections in their left arm, auto-injector 2 may send a recommendation to the patient (e.g., via a mobile application to the patient's device) to administer the next injection in a location where the patient has not previously received an injection or has not received an injection for a given period of time (e.g., the right arm). In another example, if a patient has a particular medical condition, auto-injector 2 may provide recommendations for injection sites to deliver the medication to specific locations on the body that are deemed optimal for treating that condition. In yet another example, the mobile application may provide the user with signals to identify tissue injection sites with firmer tissue based on the perceived / sensed plunger press. For example, if the mobile application receives a signal from the auto-injector 2 indicating that the plunger has not been fully or consistently depressed over a predetermined time span, the mobile application may associate this signal with a determination that the injection site tissue is not suitable for injection, and may subsequently send a notification to the user informing them of this determination and / or providing a recommendation for an alternative injection site (e.g., an injection site with firmer tissue).

[0108] Specific sales-related data associated with the auto-syringe 2 can also be tracked. For example, the number of auto-syringes in stock at a specific location (e.g., a clinic, hospital, or other type of retail store) can be continuously tracked to prevent that location from running out of stock. In one embodiment, if the number of auto-syringes at a particular location becomes low (e.g., if the number of available auto-syringes falls below a predetermined threshold), the system may be configured to automatically order more auto-syringes from the supplier.

[0109] The auto-injector 2 may also be configured to track various types of data related to drug delivery. For example, the auto-injector 2 may be configured to track how deeply the injection needle 306 has been inserted into the skin (e.g., subcutaneous layer, intramuscular layer, etc.), the strength of the adhesive securing the auto-injector 2 to the patient's body (e.g., by monitoring the pressure profile, receiving body shape instructions, receiving success indicators for each injection site, etc.), the orientation of the auto-injector 2 during the injection process (e.g., tracked by an integrated accelerometer, etc.). Artificial intelligence (AI) software may be used to assess whether HCP assistance is needed based on the characteristics of injection delivery. For example, the AI ​​may detect that a particular injection has been inserted too deeply into the patient (e.g., from data obtained from a gyroscope integrated into the auto-injector 2, another type of depth measurement mechanism, etc.), and / or that the auto-injector is not properly positioned relative to the patient's body, and may dynamically provide alerts on a mobile application accessible to the patient and / or on another device associated with the responsible caregiver.

[0110] From an HCP's perspective, aggregate information obtained from multiple auto-injectors used by a group of patients may allow the HCP to simultaneously track the treatment status of multiple patients. For example, the HCP may monitor the status of each patient's injection process. If there is a problem with any patient's injection process, the HCP may notify the patient of their location (e.g., if the patient leaves the building) to respond to the patient more quickly. Patient location data may be obtained, for example, via a QR code on a device and / or by tracking the patient's hospital band or medical ID bracelet. In addition or alternatively, in certain embodiments, the HCP may compare aggregate data to identify which patients or groups of patients are experiencing side effects from treatment, or are achieving better outcomes than other patients.

[0111] In some cases, a mobile application may prompt the patient for additional contextual data that can then be used to improve the auto-injector 2 and / or patient experience. For example, the patient may be prompted to: report on their experience using the device (e.g., pain level, observed leakage, comfort level, bolus size, who administered the device (e.g., assistant), the site where the device was administered (e.g., thigh, abdomen), take a photograph of the administration site (e.g., for later evaluation by an HCP or clinician), provide a display of their medication list (e.g., to monitor for the occurrence of interactions), provide biometric information (e.g., blood pressure, heart rate, etc.) for adverse event analysis, and / or provide disease progression information based on treatment. In some embodiments, the patient may be prompted to provide input on their treatment experience after each treatment, after side effects to the treatment have been identified, after errors in use have been detected, etc.

[0112] Other types of data may be tracked by the auto-injector 2 and / or transmitted to a mobile application and / or one or more other designated devices. For example, geographical data of all auto-injectors in circulation may be tracked to provide an indicator of where the need for auto-injectors is higher and inform manufacturing and supply chain decisions. Purchase information of auto-injectors may be recorded to ensure that there is no shortage of supply in any location or population. In addition or alternatively, in some embodiments, geographical data may be used to inform other treatment decisions. For example, if some or a large number of patients associated with a particular geographical area are experiencing side effects to a particular form of treatment, an HCP may be prompted to investigate whether the characteristics of the treatment offered to patients need to be adjusted (e.g., taking into account various environmental factors, etc.).

[0113] Figures 26–50 provide a summary of non-limiting data types that can be tracked by the auto-injector 2 and / or transmitted to one or more other devices and / or applications for presentation. For example, various types of visual representations (e.g., in the form of graphs or charts) can be generated for any of the tracked data (e.g., graphs showing the date of device use, the amount of medication delivered per use, etc.). These charts allow viewers to more quickly understand how consistently the patient is taking the medication, how accurately the medication is being delivered (e.g., whether substantially the same amount of medication is delivered each time, whether the delivered amount varies from dose to dose, etc.). Data summarizing patient hesitations and concerns about use can also be tracked. These comments can then be used to adjust aspects of the auto-injector 2 to improve the functionality of the device and the user experience.

[0114] The auto-injector 2 may be configured to detect patient reaction symptoms at the injection site. For example, it may detect heat and / or swelling at the injection site, and if this heat and / or swelling is greater than a predetermined threshold, it may serve as an indicator that an adverse reaction is occurring. For example, a temperature sensor may be placed on the skin contact surface adjacent to the injection site, and this temperature sensor is configured to measure the change in temperature from the first moment the needle 306 contacts the skin throughout the injection process. A change in skin temperature exceeding a predetermined threshold temperature, or a change in skin temperature occurring within a predetermined period, may indicate a patient reaction. In some embodiments, the location where the patient receives the injection (e.g., at home, in a hospital, etc.) may be logged. Characteristics associated with injections administered at multiple location points may be compared to determine whether one location is "better" than another in terms of correct device operation, a better patient experience, etc.

[0115] Figure 24 discloses various methods for collecting and storing data related to the auto-injector 2 from three perspectives: the patient's perspective, the HCP's perspective, and the clinician / clinical research perspective.

[0116] With regard to the patient, data may be collected and transmitted using one or more sensors, components, and / or protocols associated with the device itself (e.g., a camera, a Global Positioning System (GPS) 1463, an accelerometer 1469, a Bluetooth beacon, a printer, a Near Field Communication (NFC) antenna 1471, a gyroscope 1467, wired communication (e.g., a USB port 1473)). In addition or alternatively, one or more external devices may be configured to communicate with electronic devices integrated into the auto-injector 2 (e.g., various mobile devices such as phones, tablets, laptops and / or hybrid devices, USB, microUSB, etc.) and receive and / or capture the aforementioned data types. Possible modes of communication between external devices and the auto-injector 2 can be facilitated by Bluetooth, NFC, physical connection, etc. The user may interact with applications residing on these devices to input and receive information, update calendar data, scan QR codes, and take images of relevant administration events (e.g., injection site images). In some embodiments, the auto-injector 2 may be compatible with certain add-on devices. For example, a Polaroid camera may be connected to the auto-injector 2 and configured to print various types of images and / or data. In another example, a medical / hospital bracelet may connect wirelessly to the auto-injector 2 and may also include a camera component for scanning a QR code on the bracelet. In some embodiments, the bracelet may include a scannable micro USB that can communicate with the auto-injector 2 to store data. For elderly patients, additional connectivity features may be considered that may improve the user experience. For example, knowing that the patient is over a certain age and / or has certain limited abilities, the auto-injector 2 may be configured to send a signal to the HCP service that triggers a call to the patient's landline telephone (e.g., if the patient does not have a mobile device, etc.). Similarly, the auto-injector 2 may be configured to send information to the HCP for the patient's medical records and / or to automatically update the patient records and mail a summarized letter to the patient.

[0117] From an HCP perspective, various tools can be used to acquire, store, and / or display data from the auto-injector. For example, substantially real-time data related to one or more patients can be tracked and presented on various devices (e.g., monitors, laptops, pagers, televisions, etc.) to ensure patient compliance (e.g., compliance with injection schedules). Data obtained by the auto-injector 2 may be stored in the device itself (e.g., in an integrated database) and later retrieved manually, provided to add-on devices or external components, and / or wirelessly transmitted to another storage location (e.g., a server). The frequency at which data is transmitted to other devices may vary (e.g., data may be transmitted each time it is collected, only when a predetermined amount of data has been collected, or when a predetermined event (e.g., receipt of a command from an HCP or other user to transmit data) is detected).

[0118] From a clinical research perspective, transmitting data to an external database (e.g., via Bluetooth) can provide live updates on trends, errors, and correlations between data types. If the data is physically stored on the device itself, it can be manually extracted and uploaded to a central data processing unit for analysis.

[0119] Figures 26–50 provide a summary of non-limiting methods for collecting and storing auto-injector data from the perspective of patients, HCPs, and / or clinicians / clinical research.

[0120] From the patient's perspective, in one embodiment, some or all of the data acquired on the patient's device may be compiled into a PDF report that can be sent via email, text, etc. In another embodiment, once the injection is complete, a notification may be sent to the patient's device (or present on a mobile application accessible via the patient's device) prompting the patient to complete a log or questionnaire to track their experience. In yet another embodiment, the patient's calendar may be automatically updated to reflect the next medication event. In yet another embodiment, a notification may be sent to the patient reminding them of the next medication event.

[0121] From an HCP perspective, in one embodiment, data related to each administration may be automatically entered into the patient's file. This data may be shared with any individual who may come into contact with the patient and / or be responsible for their care (e.g., nurses). The patient may have some control over which types of data are automatically synchronized to the HCP portal. In another embodiment, the HCP may receive alerts when the patient needs assistance with medication administration. This information may be used by the HCP to improve the subsequent patient experience (e.g., scheduling a nurse or other individual to be present at the designated medication time).

[0122] From a clinician's perspective, in one embodiment, there may be a clinical trial portal that can be configured to automatically populate patient-specific databases. The clinical trial portal can track any warnings that occurred during the experience of use, and / or any adverse events that may have occurred in the patient during or after use. In another embodiment, the clinical trial portal can identify any trends that have occurred in the patient data, and these trends can be automatically updated as new data is received.

[0123] In some embodiments, the auto-injector 2 may be configured to assist the user in finding the auto-injector 2. For example, the auto-injector 2 may be configured to pair with a mobile device before use. The auto-injector 2 may be configured to enter a low-power mode with wireless connectivity enabled while in its packaging before use. As previously stated herein, the auto-injector 2 may be enabled in any one or more suitable wireless modes, such as, for example, Bluetooth or Bluetooth low energy (BLE) module 1457, near-field communication (NFC) module 1417, infrared, cellular network connectivity (e.g., cellular modem 1421), and wireless network connectivity (e.g., WiFi module or network card 1419). In some embodiments, the auto-injector 2 or its packaging may be provided to the user with a QR code or barcode. The user may scan the QR code or barcode with a mobile device to pair the mobile device with the auto-injector 2. Alternatively, or in addition to the above, the auto-injector 2 may be in pairing mode by default when in its packaging in low-power mode. In such a case, when the mobile device approaches the auto-injector 2, the user may detect the auto-injector 2 on the mobile device. The user may then be prompted to pair the auto-injector 2 with the mobile device. In yet another embodiment, the auto-injector 2 may be pre-configured to pair with a specific user's mobile device. For example, the HCP may be pre-configured to associate the auto-injector 2 with a user account in a mobile application. The user may use the mobile application to detect and pair the auto-injector 2 via a unique communication channel and / or an encrypted communication channel.

[0124] Once the user's mobile device is paired with the auto-syringe 2, the user may use the mobile device to find the auto-syringe 2 if it is misplaced. In some embodiments, the user may use the mobile device to turn on the light of the auto-syringe 2 and / or make the auto-syringe 2 emit a sound. Furthermore, the user may use the mobile device to make the auto-syringe 2 emit haptic feedback such as vibration. The user may then use the light, sound, and / or haptic feedback to locate the device. In some embodiments, the user may use the mobile device to track the geographical location of the auto-syringe 2. The mobile device may use a wireless connection with the auto-syringe 2 and / or GPS functionality to display the location of the auto-syringe 2 on a map.

[0125] In some embodiments, the auto-injector 2 may be configured to warn the user whether the auto-injector 2 and / or the drug inside it are at risk in connection with an attempt to locate the auto-injector 2. For example, the auto-injector 2 may transmit information to a mobile device indicating that the auto-injector 2 has been exposed to an unsuitable environment, such as an environment that is excessively hot or cold. In some embodiments, the auto-injector 2 may transmit information to a mobile device indicating the rate of temperature change of the drug inside the auto-injector 2. In such embodiments, a warning may be provided to the user via the mobile device indicating that the temperature of the drug is approaching a threshold that makes it unsafe to administer the drug. The warning may include an estimated time until the threshold is reached.

[0126] In some embodiments, the auto-injector 2 may transmit information to the mobile device 1407 indicating that the auto-injector 2 and / or associated packaging have been tampered with during a predetermined period before the location tracking function is activated. In some examples, the auto-injector 2 may transmit information to the mobile device 1407 indicating that the auto-injector 2 has been moved in an improper manner. For example, the auto-injector 2 may transmit information indicating that it has been dropped or subjected to other impacts that may impair its function. In some embodiments, if the auto-injector 2 has been used to complete an injection sequence, the auto-injector 2 may transmit an indication to the mobile device indicating that it has been used. In some embodiments, the device location tracking function may be disabled after the injection sequence.

[0127] In some embodiments, the auto-injector 2 may be configured to provide location information to parties other than the user, such as the device manufacturer, HCP, and pharmacy. For example, the location tracking function may be enabled before the auto-injector 2 is shipped. The auto-injector 2 may be configured to provide location information to the manufacturer, HCP, pharmacy, etc., before shipment. After shipment, the relevant parties may track the location of the auto-injector 2 to ensure that it is transported as expected. The relevant parties may track the location of the auto-injector 2, for example, to deter theft and / or fraud. In some embodiments, the relevant parties may automatically receive a warning if the auto-injector 2 deviates from an expected or predetermined route.

[0128] Figure 18 shows an exemplary method 2000 according to the present disclosure. Method 2000 begins in step 2002, in which the user may position the auto-syringe 2 on their body such that the tissue engagement surface 4 is in contact with the skin surface. The user may position the auto-syringe 2 on their skin after removing the locking component 1610, as previously described herein, so that the touch sensor 1410 can detect the proximity of the skin. The auto-syringe 2 may be attached to any suitable location, such as the thigh, abdomen, shoulder, forearm, upper arm, leg, buttocks, or another suitable location. The auto-syringe 2 may be secured to the skin by an adhesive patch 12. The securing of the auto-syringe 2 in step 2002 may be interrupted by pressing an activation switch 1409 that extends outward from the tissue engagement surface 4, thereby interrupting the circuit. Disrupting the circuit may cause a signal to be sent to the controller 1408 indicating that the activation switch 1409 has been pressed. Alternatively, any other suitable mechanism may power on or activate the auto-injector 2 before or after step 2002. When the activation switch 1409 is pressed, the auto-injector 2 may emit an audible sound and / or illuminate one or more LEDs (e.g., one or more LEDs of a first color, e.g., blue) to indicate that the activation switch 1409 has been pressed.

[0129] If the auto-injector 2 is activated in step 2002, method 2000 may proceed to step 2004, in which the controller 1408 may determine whether the tissue engagement surface 4 is located on a skin surface. In step 2004, the controller 1408 may receive a measurement from the touch sensor 1410 indicating whether the auto-injector 2 is located on skin or another surface. For example, if the touch sensor 1410 is in contact with skin when the capacitance value received from the touch sensor 1410 is within a predetermined range, method 2000 may proceed to step 2008. For example, if the touch sensor is not in contact with skin when the capacitance measurement received from the touch sensor 1410 indicates that the auto-injector 2 is in contact with a non-skin surface such as wood or metal, method 2000 may proceed to step 2006. In step 2006, the auto-injector 2 may be put into an error state. In an error state, an LED (e.g., a red LED) may be activated to indicate to the user that an error has occurred, or a message may be displayed on the display screen. In some examples, the auto-injector 2 may need to be manually reset before the injection can be completed. In other examples, the auto-injector 2 may loop back to step 2004, where the controller 1408 continuously attempts to determine whether the touch sensor 1410 is in contact with the skin. Method 2000 may also require the touch sensor 1410 to be in contact with the skin throughout the entire injection. Thus, if at any point during the injection the controller 1408 determines that the touch sensor 1410 is no longer in contact with the skin, the controller 1408 may stop the injection (e.g., by stopping further movement of the translation mechanism 1366), generate an error signal or message, and retract the needle 306 if it was extended. By stopping the injection and retracting the needle 306, the risk of administering the drug outside the body (i.e., wet injection) and / or needle stick injury may be reduced.At the determination in step 2004, the auto-injector 2 may emit an audible sound and / or illuminate one or more LEDs to indicate that the auto-injector 2 is positioned on the skin surface. In one example, one or more additional LEDs of a first color may be illuminated at this stage to indicate further progress of the injection.

[0130] In step 2008, the controller 1408 may transmit a signal to activate the translation mechanism 1366. When activated, the translation mechanism 1366 moves toward the second end 1306 of the cartridge 1302 (see Figures 13 and 14), and may move the cartridge 1302 itself in the same direction. This may move the needle 308 in the opposite direction to access the cartridge 1302, as described above. The movement of the driver 1398 and the needle 308 moves the carrier 202 in the same direction, which explains the sequence of events by which the needle 306 is finally deployed into the user by the mechanism described in Figures 5 to 11. The translation mechanism 1366 continues to move toward the second end 1306 until the desired amount of medication contained in the cartridge 1302 is administered to the user. When the translation mechanism is activated, the auto-injector 2 may emit an audible sound and / or illuminate one or more LEDs to indicate that injection is in progress. For example, additional LEDs of the first color may be illuminated as the injection progresses, providing the user with a visual indication of the progress.

[0131] Method 2000 proceeds to step 2010, where the controller 1408 may determine whether the injection is complete. This determination may be based on the blocking of the beam 1430 by the piston 1316 (as described with reference to Figures 4A, 13, and 14). That is, when the beam 1430 is blocked (not received by the detector 1416), the controller 1408 may determine that the injection is complete. Once the controller 1408 determines that the injection is complete, it may transmit a signal to the translation mechanism 1366 to reverse the rotation direction of the main screw, thereby allowing the lamp 1500 to push the lamp 243 of the stopper 240, enabling the retraction of the needle 306 as described above with reference to Figure 11. In one example, the controller 1408 may introduce a delay after receiving the indication that the beam 1430 has been blocked. The delay may be, for example, 0.1 seconds to 60 seconds.

[0132] In addition, a different end detection mechanism may be used instead of, or in combination with, the above-mentioned interruption-type sensor. For example, the motor current of the translation mechanism 1366 can be used to determine whether the injection is complete. That is, when the piston 1316 reaches the second end 1306 of the cartridge 1302, the motor current increases (for example, as a result of the piston 1316 engaging with the end of the cartridge 1302), and all or substantially all of the contents of the cartridge 1302 are ejected. One exemplary combination may include the use of a beam 1430, where the interruption of the beam 1430 indicates, for example, that 90-98 percent of the injection is complete. Then, the motor current of the translation mechanism 1366 can be analyzed to determine whether the remaining 2-10 percent of the injection is complete. In another example, instead of using an optical switch, a delay from the start of the translation mechanism 1366 may be used by the controller 1408 to determine when to reverse the translation mechanism 1366. In one example, this delay could be, for example, about 1 second to about 120 seconds, but other appropriate times are also intended. In any case, the delay from the start can be long enough to allow the cartridge 1302 to be emptied. In yet another example, the beam 1430 can be used in conjunction with the encoder. The encoder may be configured to detect the position of the piston 1316. If the encoder alone is used to detect the position of the piston 1316, drive system issues may interfere with accurate detection. For example, the piston 1316 may rotate when pushed by the main screw. Such rotation can introduce uncertainty regarding the actual position of the piston 1316. However, when used with the beam 1430, the controller 1408 may be configured to recalibrate the encoder in response to the interruption of the beam 1430. Such recalibration may allow the controller 1408 to update the actual position of the encoder and resume accurate detection of the position of the piston 1316 using the encoder.

[0133] When it is determined that the injection is complete, the auto-injector 2 may indicate the completion of the injection by emitting an audible sound and / or by illuminating one or more LEDs. In some examples, one or more LEDs of a second color (e.g., green) different from the first color may be illuminated to inform the user that the injection is complete. In some examples, all LEDs of the device may be illuminated in the second color, and other indicators may also be used. For example, all LEDs may be illuminated in the second color and may also blink intermittently at the end of the injection.

[0134] In some cases, the timing of the injection procedure, measured from the initial activation of the activation switch 1409 to the retraction of the needle 306 away from the user after drug delivery, can be approximately 20 to 90 seconds, or approximately 25 to 60 seconds, approximately 30 to 45 seconds, or approximately 120 seconds or less, or approximately 90 seconds or less, or approximately 60 seconds or less, or approximately 45 seconds or less, or approximately 30 seconds or less. Such timing represents a significant improvement over existing devices where the injection timing can be considerably longer, sometimes as long as approximately 9 minutes or more.

[0135] Method 2000 may also include additional steps. For example, Method 2000 may include steps to determine whether the drug in cartridge 1302 is too cold to deliver to the user, whether the power supply 1406 has sufficient energy to complete the injection, whether the needle 306 has been deployed and / or retracted prematurely, whether the current of the motor of the translation mechanism 1366 is within an appropriate range, and whether the injection procedure has been extended beyond the maximum allowable procedure time. If the controller 1408 detects any of the above errors, it may communicate such errors to the user and terminate the injection in progress by, for example, stopping or reversing the translation mechanism 1366 and retracting the needle 306 away from the user. The auto-injector 2 may emit an audible sound indicating any of the additional steps described above and / or illuminate one or more LEDs. For example, one or more LEDs of a third color (e.g., red) different from the first and second colors may be illuminated.

[0136] Figure 20 shows an exemplary method 2020 for controlling the torque of the motor of the translation mechanism 1366 and detecting the point at which the motor stalls. In step 2022, the controller 1408 may initiate the injection sequence. As previously stated herein, the injection sequence may be initiated by pressing the start switch 1409 against the user's skin and / or by detecting the user's skin by the touch sensor 1410. During the injection sequence, the motor of the translation mechanism 1366 may be driven by applying a voltage to it.

[0137] In step 2024, as the injection sequence progresses, the controller 1408 may maintain the motor of the translation mechanism 1366 at a constant speed. The constant speed may be, for example, a rotational speed measured in revolutions per minute (RPM). The controller 1408 may maintain the motor at a constant speed by changing the voltage applied to the motor. For example, if a higher load is applied to the motor due to an obstacle, increased fluid pressure, increased part friction, or other cause, the controller 1408 may compensate for the increased load by increasing the voltage applied to the motor. Conversely, if the load applied to the motor decreases, the controller 1408 may compensate for the decrease in load by decreasing the voltage applied to the motor. Maintaining the motor at a constant speed may reduce the likelihood of the user experiencing pain at the injection site. For example, maintaining the motor at a constant speed may prevent the bolus from becoming excessively large, thereby reducing the risk of pain.

[0138] During the injection sequence, the controller 1408 may monitor the current supplied to the motor. The motor current may indicate the torque generated by the motor. For example, a higher motor current may indicate a higher torque being generated by the motor. In step 2026, the controller 1408 may determine whether the motor current exceeds a first current threshold. The first current threshold may be determined and / or set based on the maximum torque that can be safely generated by the motor. The maximum torque may be reached, for example, when the injection sequence is interrupted in any way. If the controller 1408 determines that the motor current does not exceed the first current threshold, method 2020 returns to step 2024, and the controller 1408 may continue to maintain the motor at a constant speed. On the other hand, if the controller 1408 determines that the motor current exceeds the first current threshold, method 2020 may proceed to step 2028.

[0139] In step 2028, the controller 1408 may reduce the motor voltage to maintain the motor current below a second current threshold. In some embodiments, the second current threshold may be greater than the first current threshold and may be more closely correlated with the maximum torque that the motor can safely generate. In some embodiments, the second current threshold may be less than or equal to the first current threshold. If the injection sequence is interrupted, the motor speed may slow down and the motor impedance may decrease. As the motor impedance decreases, a lower voltage may be required to maintain the motor current below the second current threshold. The controller 1408 may monitor the average motor voltage applied to the motor. The average motor voltage may be, for example, time-averaged.

[0140] Steps 2024–2028 of Method 2020 can generally be illustrated by the graph depicted in Figure 20B, in which a curve representing the relationship between the voltage applied to the motor of the translation mechanism 1366 and the current consumed by the motor is plotted. The curve can be characterized by the following equation: V = iR + Vemf

[0141] In the above equation, V is the voltage applied to the motor, i is the current consumed by the motor, R is the coil resistance of the motor, V emf V is the back electromotive force acting with respect to the applied voltage at a given speed. As shown in Figure 20B, the curve may include a constant speed region in which the motor can be maintained at a constant speed (step 2024). In the constant speed region, V emf The coefficient can remain nearly constant, and the curve can be nearly linear.

[0142] As shown in Figure 20B, the current consumed by the motor may increase as the load (i.e., torque) acting on the motor of the translation mechanism 1366 increases. As the current approaches the maximum current, the voltage applied to the motor may decrease to keep the current below the maximum current (steps 2026 and 2028). The current consumed by the motor may be kept below the maximum current using proportional-integral (PI) control. As illustrated, there may be a minimum voltage at which the motor will stall.

[0143] Steps 2030-2038 of Method 2020 may correspond to a control sequence for preventing motor stall. Figure 20A shows a graph that may represent the voltage applied to the motor and the current consumed by the motor over time according to steps 2030-2038.

[0144] In step 2030, the controller 1408 may determine whether the average motor voltage has dropped below a first threshold voltage. A drop in the average motor voltage below the first threshold voltage may indicate that the injection sequence is being interrupted. If the controller 1408 determines that the average motor voltage has not dropped below the first threshold voltage, method 2020 returns to step 2028, and the controller 1408 may continue to maintain the motor current below a second current threshold. Figure 20A illustrates five intervals in which the controller 1408 may maintain the motor current at a constant value (e.g., below a second current threshold), namely, approximately 35 seconds to approximately 37 seconds, approximately 39 seconds to approximately 41.5 seconds, approximately 43.5 seconds to approximately 46 seconds, approximately 48 seconds to approximately 50.5 seconds, and approximately 52.5 seconds to approximately 55 seconds. As shown in Figure 20A, the voltage applied to the motor during each interval may decrease, with some variation, to keep the motor current below the second current threshold. Although the voltage during each interval in Figure 20A is shown decreasing, the voltage does not necessarily need to decrease to keep the motor current below the second current threshold; instead, it may be kept flat in certain circumstances.

[0145] On the other hand, if the controller 1408 determines that the average motor voltage has fallen below a first threshold voltage, the controller 1408 may pause the injection sequence for a first time interval. When pausing the injection sequence, the controller 1408 may stop applying voltage to the motor. In some embodiments, the first time interval may be, for example, 2 seconds. Figure 20A shows four such pauses between approximately 37 seconds and 39 seconds, between approximately 41.5 seconds and 43.5 seconds, between approximately 46 seconds and 48 seconds, and between approximately 50.5 seconds and 52.5 seconds.

[0146] The first time interval may be long enough to allow the fluid pressure in the auto-injector 2 to dissipate. Alternatively, the first time interval may be short enough not to prompt the user to remove the auto-injector 2 from their skin (for example, the first time interval may be set shorter than the user's typical reaction time to misidentify the end of the injection). The first time interval may also be visually indicated by the illumination of one or more LEDs on the progress ring or by another light within the auto-injector 2. To indicate the first time interval and that the injection sequence is paused rather than stopped, the LEDs may be illuminated, for example, in a specific pattern or according to a specific color scheme.

[0147] After pausing the injection sequence, the controller 1408 may resume the injection sequence in step 2034. To resume the injection sequence, the controller 1408 may resume supplying voltage to the motor of the translation mechanism 1366. In step 2036, the controller 1408 may determine whether the average motor voltage has fallen below a first threshold voltage within a second time interval. The second time interval may be shorter than the first time interval and may be set and / or determined to indicate confirmation that the injection sequence is being interrupted. The second time interval may be, for example, about 0.9 seconds. If the motor voltage has not fallen below a first threshold voltage within the second time interval, method 2020 may return to step 2030. On the other hand, if the controller 1408 determines that the motor voltage has fallen below a first threshold voltage within the second time interval, method 2020 may proceed to step 2038, and the controller 1408 may abort the injection sequence.

[0148] In some embodiments, when the controller 1408 is performing steps 2028-2036, it may perform step 2026 consecutively. For example, when steps 2028-2036 are performed, the controller 1408 may continue to determine whether the motor current exceeds a first current threshold. If the motor current continues to exceed the first current threshold, method 2020 may proceed to steps 2028-2036 as described herein. On the other hand, if the motor current falls below the first current threshold, method 2020 returns to step 2024, and the controller 1408 may maintain the motor at a constant speed. In other words, if a high load on the motor due to an obstacle, high fluid pressure, etc., dissipates during the execution of steps 2028-2036, the controller 1408 may simply return to maintaining a constant motor speed rather than unnecessarily proceeding to the remaining steps.

[0149] Therefore, Method 2020 may enable the controller 1408 to effectively distinguish between a situation in which the needle may be partially blocked or a high frictional force may act on the injection sequence, and a situation in which the injection sequence is so obstructed that it cannot be overcome. In the former situation, the auto-injector 2 is capable of completing the injection sequence, and the injection sequence is not terminated prematurely. In the latter situation, the auto-injector 2 is not capable of completing the injection sequence, and the injection sequence is terminated appropriately. In such a situation, the auto-injector 2 may emit an audible sound and / or illuminate one or more LEDs to indicate that the injection has been terminated before completion. Method 2020 may further enable the cartridge 1302 to be used on an emergency basis, for example, when the user administers an injection without first warming the auto-injector 2 to reduce the viscosity of the drug. Method 2020 further allows the injection of viscous drugs to proceed at a slower speed than otherwise permissible for the motor and gear reduction ratios.

[0150] Figure 21 shows an exemplary method 2100 for detecting the end of drug administration using emitter 1414 and detector 1416. Method 2100 can be used, for example, to detect the time when the entire dose of the drug has been administered to the user and to terminate the corresponding injection sequence.

[0151] In step 2102, the controller 1408 may initiate the injection sequence. As previously stated herein, the injection sequence may be initiated by pressing the activation switch 1409 against the user's skin and / or by detecting the user's skin by the touch sensor 1410. In step 2104, the controller 1408 may repeatedly turn the emitter 1414 on and off periodically. The emitter 1414 may be rapidly turned on and off in a rectangular wave pattern so that the emitter 1414 is turned on and off several times per second. The repeated on and off of the emitter 1414 allows the detector 1416 to be exposed to light generated by the emitter 1414 in combination with ambient light, and also to ambient light alone.

[0152] In step 2106, the controller 1408 may receive a first signal from the detector 1416 corresponding to the time when the emitter 1414 is off. The first signal may correspond to and / or indicate ambient light detected by the detector 1416. In step 2108, the controller 1408 may receive a second signal from the detector 1416 corresponding to the time when the emitter 1414 is on. The second signal may correspond to and / or indicate light emitted by the emitter 1414 in combination with ambient light, such as that detected by the detector 1416.

[0153] In step 2110, the controller 1408 may calculate the difference between a first light quantity represented by a first signal and a second light quantity represented by a second signal. This difference can indicate the amount of light detected by the detector 1416 that is due to light emitted by the emitter 1414, rather than ambient light. In step 2112, the controller 1408 may determine whether the difference is less than a threshold. If the controller 1408 determines that the difference is not less than a threshold, method 2100 may return to step 2106. On the other hand, if the controller 1408 determines that the difference is less than a threshold, the controller 1408 may terminate the injection sequence in step 2114.

[0154] Therefore, Method 2100 can be used to reduce the influence of ambient light when detecting the end of drug administration. Specifically, Method 2100 can address situations where ambient light can reach the detector 1416 even though the light from the emitter 1414 indicating the end of administration is blocked from reaching the detector 1416, forming a false negative reading that indicates the end of administration has not been reached.

[0155] Figure 22 shows another exemplary method 2200 for detecting the end of drug administration using emitter 1414 and detector 1416. Method 2200 can be used, for example, to detect the time when the entire dose of the drug has been administered to the user and to terminate the corresponding injection sequence.

[0156] In step 2202, the controller 1408 may initiate the injection sequence. As previously stated herein, the injection sequence may be initiated by pressing the activation switch 1409 against the user's skin and / or by detecting the user's skin by the touch sensor 1410. In step 2204, the controller 1408 may activate the emitter 1414 or cause the emitter 1414 to emit light.

[0157] In step 2206, the controller 1408 may continue the injection sequence for a first period. The first period may be a predetermined period corresponding to a time when it is unlikely or improbable that the entire dose will be administered. For example, the first period may be approximately 20% to 50% of the total injection time. During the first period, the controller 1408 cannot interrupt the injection sequence in response to a signal received from the detector 1416 (however, it can interrupt the injection sequence due to an obstruction or stall, as illustrated with reference to Figure 20).

[0158] In step 2208, after the end of the first period, the controller 1408 may determine whether the amount of light received by the detector 1416 is less than a first threshold light amount. The controller 1408 may make this determination based on the signal received from the detector 1416 indicating the light received by the detector 1416. The first threshold light amount may correspond to the amount of light received by the detector 1416 at the end of administration. If the controller 1408 determines that the amount of light received by the detector 1416 is not less than the first threshold light amount, the controller 1408 continues the injection sequence, and method 2200 may remain at step 2208. On the other hand, if the controller 1408 determines that the amount of light received by the detector 1416 is less than the first threshold light amount, the method may proceed to step 2210.

[0159] In step 2210, the controller 1408 may determine whether the amount of light received by the detector 1416 is equal to or greater than a first threshold amount. If the controller 1408 determines that the amount of light received by the detector 1416 has risen to or greater than the first threshold amount, the controller 1408 continues the injection sequence, and method 2200 may return to step 2208. On the other hand, if the controller 1408 determines that the amount of light received by the detector 1416 remains below the first threshold amount, the method may proceed to step 2212. Step 2210 effectively allows the controller 1408 to "clear" an abnormal interruption in the injection sequence of light received by the detector, which may be caused by bubbles in the cartridge 1302 blocking the light path between the emitter 1414 and the detector 1416, for example, if the amount of light subsequently meets or exceeds the first threshold amount.

[0160] In step 2212, the controller 1408 may determine whether the motor current exceeds a first current threshold. The first current threshold may be determined and / or set based on a current indicating the end of the injection sequence. The first current threshold may be set, for example, based on a current indicating that the piston 1316 has reached the second end 1306 of the cartridge 1302. If the controller 1408 determines that the motor current does not exceed the first current threshold, the controller 1408 may continue the injection sequence, and method 2200 may return to step 2208. On the other hand, if the controller 1408 determines that the motor current has exceeded the first current threshold, method 2200 may proceed to step 2214, and the controller 1408 may terminate the injection sequence.

[0161] Therefore, Method 2200 enables precise identification of the end of an injection sequence by identifying the moment when both the light received by the detector 1416 and the motor current indicate the end of administration. By performing steps 2208, 2210, and 2212 sequentially, misidentification of the end of administration due to either an abnormal interruption of light or an abnormal high-current event alone can be mitigated. In particular, Method 2200 can reduce the influence of bubbles in cartridge 1302 on the detection of the end of drug administration.

[0162] Figure 23 shows an exemplary method 2300 for operating the activation switch 1409 of the automatic syringe 2 according to this disclosure. In particular, Figure 23 shows an exemplary sequence of the position of the activation switch 1409 and the corresponding function of the automatic syringe 2.

[0163] First, in step 2302, the auto-syringer 2 may be placed in the package such that the plunger 1450 is in the depressed position and the auto-syringer 2 is in low-power sleep mode. In some embodiments, during manufacturing, the auto-syringer 2 may be programmed to be in an awake or active state. In some embodiments, the auto-syringer 2 may be configured to transition to low-power sleep mode if the plunger 1450 is depressed for a predetermined period after programming, such as when the auto-syringer is placed in the package. The predetermined period may be any suitable period such as 60 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 2 minutes, or any other suitable period. The auto-syringer 2 may be sealed in the package such that the package indicates that the auto-syringer 2 has not been previously used. The package may be made from any suitable material, including paper, cardboard, plastic, cellophane, etc. The package can press down on the plunger 1450 so that the plunger 1450 is flush or nearly flush with the housing 3 of the autosyringer 2 and prevents the plunger 1450 from extending outward from the autosyringer 2. When the plunger 1450 is pressed down, the circuit associated with the activation switch 1409 is open, thereby keeping the autosyringer 2 in a low-power sleep mode.

[0164] In step 2304, the auto-syringe 2 can be removed from the package such that the plunger 1450 is no longer pressed down by the package and the plunger 1450 extends outward from the auto-syringe 2. When the plunger 1450 moves from the pressed-down state to the free or extended state, the plunger flange 1454 can contact or press down the plunger switch 1448, thereby completing the circuit associated with the activation switch 1409.

[0165] In step 2306, in response to the completion of the circuitry associated with the activation switch 1409, the auto-injector may transition from low-power sleep mode to active mode. In active mode, the auto-injector 2 may calibrate the touch sensor 1410. The auto-injector 2 may calibrate the touch sensor 1410 by detecting the value or measurement of the touch sensor 1410 in ambient air that is not in contact with the user's skin. The auto-injector 2 may perform such calibration during a predetermined period after (and possibly immediately after) the auto-injector 2 has been removed from the package, and such calibration is performed before the user exposes their skin to the touch sensor 1410. In active mode, the auto-injector 2 may further detect whether the emitter 1414 and / or detector 1416 are functioning properly, whether the needle is properly positioned, whether the motor of the translation mechanism 1366 is responsive and / or operable, and / or perform other appropriate condition tests. The auto-injector 2 may detect the needle position, for example, using a switch or detector configured to report the needle position to the controller 1408. In active mode, the auto-injector 2 may further illuminate one or more backlights to allow the user to inspect the vial and / or the drug contained in the vial through the transparent window 50. In active mode, the auto-injector 2 may further display other indicators indicating that the auto-injector 2 is ready for use.

[0166] In step 2308, the auto-injector 2 may be positioned against the user's skin so that the plunger 1450 is pushed down into the auto-injector 2. When the plunger 1450 is pushed down, the activation switch 1409 and associated circuitry may be moved to the open state. As described above with reference to Figure 18 and Method 2000, the auto-injector 2 may further detect contact with the skin using the touch sensor 1410. In response to the detection of the plunger 1450 being pushed down and contact with the skin, the auto-injector 2 may initiate the injection sequence in step 2310. The injection sequence may be a sequence that injects a drug into the user, as described herein.

[0167] In step 2312, the auto-injector 2 is removed from the user's skin, and the plunger 1450 may again extend outward from the auto-injector 2. When the plunger 1450 extends outward, the circuit associated with the activation switch 1409 may transition from an open state to a closed state. In response, the auto-injector 2 may terminate the injection sequence in step 2310 and begin retracting the patient's needle, for example, by reversing the motor. The auto-injector 2 may begin retracting the needle to prevent wet injection if the injection sequence has progressed to completion, or if the auto-injector is removed from the skin prematurely or accidentally. Alternatively, in some embodiments, the controller 1408 may determine whether the value received from the touch sensor 1410 indicates that the auto-injector 2 remains in contact with the user's skin. If the value received by the controller 1408 indicates that the auto-injector 2 remains in contact with the user's skin, the auto-injector 2 may pause the injection sequence, thereby preventing wet injection. When the plunger 1450 is pushed down again, thereby opening the circuit associated with the start switch 1409, the automatic syringe 2 can resume the injection sequence.

[0168] According to the method 2300 described above, the activation switch 1409 may function to keep the auto-syringe 2 in a low-power sleep mode when it is inside the package, and to transition the auto-syringe 2 to an active mode when it is removed from the package, indicating that the auto-syringe 2 has been placed against the user's skin for the injection sequence, and indicating that the auto-syringe 2 has been removed from the user's skin at the end of the injection sequence. Furthermore, the signal from the activation switch 1409 may be compared with the signal from the touch sensor 1410 to more accurately determine whether the auto-syringe 2 has been removed from the user's skin, or whether, for example, an accidental or minor movement of the auto-syringe has occurred.

[0169] Data collection and transmission

[0170] Figure 24 shows an exemplary schematic diagram for data collection, storage, and transmission from the auto-injector 2. Data may flow bidirectionally, allowing a healthcare provider (HCP) 1451 or clinical trial administrator 1453 to communicate with a patient 1447 or a user 1449 of the mobile device 1407. The data may be stored locally in the non-volatile memory (NVM) of the auto-injector 2 or the NVM of the mobile device 1407, or remotely, for example, on a cloud server. Dictionaries, language structures, and / or key-value pairs may be employed for data storage.

[0171] Figure 25 shows a functional block diagram illustrating how the auto-injector 2 and the mobile device 1407 transmit data to each other and from the mobile device 1407 to the patient 1447, user 1449, HCP 1451, and clinical trial administrator 1453. For example, data collected by the auto-injector 2 may be transmitted to the controller 1475 of the mobile device 1407 via the wireless communication module 1411 of the auto-injector 2. In particular, the auto-injector 2 may transmit data to the wireless communication module 1415 of the mobile device 1407 via the wireless communication module 1411 of the auto-injector 2 by any suitable method, including communication via near-field communication (NFC) 1417 or Bluetooth module 1457, WiFi module 1419, satellite 1443, and / or cellular modem 1421 which can communicate with cellular tower 1441. Once data is transmitted from the auto-injector 2 to the mobile device 1407, the data may be selectively transmitted via the wireless communication module 1415 of the mobile device 1407 to the HCP 1451 or the clinical trial administrator 1453, or any other suitable recipient, as will be discussed in detail herein. The mobile device 1407 may transmit the data to the HCP 1451 or the clinical trial administrator 1453 via a suitable telecommunications medium, including via a cellular tower 1441, satellite 1443, the internet, Wi-Fi, and / or a remote server 1445. Once the data is sent to the HCP 1451 and / or the clinical trial administrator 1453, the HCP 1451 and / or the clinical trial administrator 1453 may aggregate all the data from one patient 1447 or multiple patients 1447 for analysis.

[0172] As previously stated herein, the controller 1408 of the auto-injector 2 may include a number of functionalities. The controller 1408 may be communicatively coupled to the wireless communication module 1411 and the sensor 1433. The controller 1408 may be configured to perform various functions, including transmitting data, information, notifications, warnings, etc., to the mobile device 1407 via the wireless communication module 1411. As will be discussed herein, the controller 1408 may be configured to disable the deployment of the needle 306 of the auto-injector 2. This may occur automatically or, for example, after receiving a command from the controller 1475 of the mobile device 1407.

[0173] To disable the automatic syringe 2, the plunger 1450 (Figures 3-3C) may be coupled to the housing 3 and made movable relative to the housing 3. One or more electronic components may be used during the injection performed by the automatic syringe 2 and may be formed within an electrical circuit. In the first configuration, the first portion of the plunger 1450 may be located inside the housing 3 and the electrical circuit may be open. In such an embodiment, one or more electronic components may be in a low-power sleep mode. In the second configuration, the plunger 1450 may be moved outward relative to the housing 3, and the first portion of the plunger 1450 extends outside the housing 3. In the second configuration, the electrical circuit is closed and one or more electronic components may transition from a low-power sleep mode to an active mode. The plunger 1450 may also be movable from the second configuration toward the housing 3 to a third configuration, and unless otherwise instructed by the controller 1408, the automatic syringe 2 may be configured to start the injection only after the plunger 1450 has been moved to the third configuration and one or more electronic components are in an active mode. However, under certain conditions described herein, the auto-injector 2 may be configured to prevent the initiation of injection even after the plunger 1450 has moved to the third configuration. For example, as discussed herein, if the drug temperature rises above a threshold temperature, the auto-injector 2 may become unusable even though the plunger 1450 has been pushed down to the third configuration.

[0174] The auto-injector 2 may include a number of additional electromechanical components. For example, the auto-injector 2 may include a thermal element 1429, which may include a heating coil powered, for example, by a battery or some other power source. The thermal element 1429 may selectively heat the drug in the cartridge 1302 based on a signal from the controller 1408 of the auto-injector 2. When a signal is received from the controller 1408, the thermal element 1429 may heat to a desired or optimal temperature related to the drug. The auto-injector 2 may be rendered unusable until the drug is heated to the desired temperature. The thermal element 1429 may be coupled to the controller 1408 of the auto-injector 2 and may take the form of a wire coil, ribbon element, tubular element, resistive wire enclosed in a ceramic or metal sheath, mica band, thick film element, and / or thermoelectric heat pump (also known as a Peltier element). The controller 1408 may raise or lower the temperature of the thermal element 1429 by selectively powering the thermal element 1429. The heating element 1429 can reach any suitable temperature for warming the autoinjector 2 and / or the drug in it. For example, the heating element 1429 can warm the drug to temperatures between approximately 0°F and 32°F, 32°F and 47°F, 47°F and 59°F, 59°F and 77°F, 77°F and 98.6°F, 68°F and 104°F, 98°F and 108°F, 122°F and 140°F, and 122°F and 158°F, as well as up to approximately 212°F, depending on the type of drug. Factors that influence the temperature range include, for example, protein stability, desired viscosity of the drug, efficacy, and / or patient comfort. The controller 1408 may be configured to raise the temperature of the thermal element 1429 while simultaneously monitoring the temperature of the thermal element 1429 and / or the drug using a thermocouple or thermometer 1437 on or inside the housing 3 of the auto-injector 2. When the controller 1408 detects a threshold temperature via the thermometer 1437, the controller 1408 may cut off power supply to the thermal element 1429. Although described as being included in or on the auto-injector 2, the thermal element 1429 may be, for example, an add-on device or a third-party device.

[0175] Figure 51 shows a thermal element 1429 within the automatic syringe 2. The automatic syringe 2 may include a thermal interface 1543 between the reusable portion 1533 and the disposable portion 1535 of the automatic syringe 2. The disposable portion 1535 may include, for example, a cartridge 1302, a translation mechanism 1366, a needle 308, and a fluid path 308c, while the reusable portion 1533 may include all other components. However, both the disposable portion 1535 and the reusable portion 1533 may each include any components described herein. The disposable portion 1535 may have a thermally conductive block 1537 for transferring heat from the interface 1543 to the fluid path. The reusable portion 1533 may include a thermal element 1429 and a sensor (e.g., a thermometer 1437 as described herein) on the block 1539 for transferring heat to the interface 1543. Interface 1543 may include a flexible thermal interface material (e.g., graphoil, braided metal, or filled rubber) between block 1539 of the reusable portion 1533 and block 1537 of the disposable portion 1533.

[0176] Figure 52 shows an embodiment substantially similar to that in Figure 51, except that the disposable portion 1535 includes a thermal element 1429, a thermometer 1437, a thermal conductive block 1537, and a thermal conductive block 1539. An electrical contact interface 1541 between the reusable portion 1533 and the disposable portion 1535 may engage when the cassette (e.g., the disposable portion 1535) is placed in the auto-syringe 2. Either portion 1533 or portion 1535 may include blocks 1537 and 1539.

[0177] As described above, the auto-injector 2 includes a thermocouple or thermometer 1437 on or inside the housing 3, which may track the temperature of multiple structures within the auto-injector 2, including the drug, the electronics of the auto-injector 2, and / or the patient's injection site. The thermometer 1437 may include a digital thermometer coupled to the controller 1408 of the auto-injector 2. The thermometer 1437 may be communicably coupled to the controller 1408 by wired or wireless connection. The controller 1408 may be configured to compare the measured temperature with a predefined and / or expected temperature range. As an example, the temperature range for the drug is between approximately -320°F and approximately -238°F, between approximately -238°F and approximately 32°F, between approximately 32°F and approximately 47°F, between approximately 47°F and approximately 59°F, between approximately 59°F and approximately 77°F, between approximately 68°F and approximately 77°F, between approximately 59°F and approximately 86°F, between approximately 77°F and approximately 98.6°F, between approximately 95°F and approximately 104°F, between approximately 98.6°F and approximately 212°F, and above approximately 212°F. If the temperature of the drug measured by the controller 1408 via the thermometer 1437 is below a predetermined threshold, the controller 1408 may start heating the drug via the thermal element 1429. As another example, the temperature range for the injection site may be approximately 95.0°F to 99.0°F. The user 1449 may initiate the heating sequence, or the heating sequence may be initiated automatically. For example, the heating sequence may be initiated when a button on the bottom of the auto-injector 2 is pressed, or, if heating is presumed to be rapid, in response to the user 1449 pressing a button on the mobile device 1407 to initiate the heating sequence. Alternatively, or in addition to the above, the heating sequence may be initiated automatically when the auto-injector 2 is removed from its manufacturing packaging. If the injection site reaches a predefined maximum temperature, the controller 1408 of the auto-injector 2 may disable the auto-injector 2. Alternatively, for comparison, the auto-injector 2 may transmit temperature data to the mobile device 1407 via the respective wireless communication modules 1411 and 1415.Based on that comparison, the auto-syringe 2 may receive a deactivation command from the mobile device 1407 that disables the fluid conduit 300 of the auto-syringe 2 from being in an deployed configuration until the auto-syringe 2 receives a second command from the mobile device 1407 that overrides the first command. In some embodiments, the thermometer 1437 may be configured to detect fluid leakage in the auto-syringe 2 by, for example, a rapid rise or fall in temperature that may indicate leakage. Although described as being included in or on the auto-syringe 2, the thermometer 1437 may be, for example, an add-on device or a third-party device.

[0178] The automatic syringe 2 may include a fluid sensor 1439 located within the housing 3, or coupled to the housing 3 and communicatively coupled to the controller 1408. The fluid sensor 1439 may include any suitable fluid detection sensor, including level sensors, pressure sensors, temperature sensors, pH sensors, conductivity sensors, turbidity sensors, chemical composition sensors, destructive pin moisture sensors, non-destructive moisture sensors, paper moisture sensors, and / or viscosity sensors. The fluid sensor 1439 may include detection elements that can interact with the detected fluid, and may include pressure-sensitive diaphragms or bellows, thermistors, electrodes for pH sensors or conductivity sensors, and / or floats. The fluid sensor 1439 may include a transducer that converts the physical characteristics of the detected leak into an electrical signal, including strain gauges, thermoelectric devices, or sets of electromagnetic coils. The fluid sensor 1439 may be communicatively coupled to the controller 1408 of the automatic syringe 2 by wire or wireless. If a leak is detected, the controller 1408 of the auto-injector 2 may transmit a leak detection signal to the mobile device 1407 via the wireless communication module 1411 of the auto-injector 2. When the leak detection signal is received by the mobile device 1407, the mobile device 1407 may be configured to display a notification to the user and / or patient of the auto-injector 2, or to disable the auto-injector 2. Although described as being contained within or on the auto-injector 2, the fluid sensor 1439 may be, for example, an add-on device or a third-party device.

[0179] The auto-injector 2 and / or mobile device 1407 may include a biometric sensor 1425. The biometric sensor 1425 may sense the biometrics of the user of the auto-injector 2 to verify that the user is an authorized user. The auto-injector 2 may include the biometric sensor 1425 on or inside the housing 3. The biometric sensor 1425 may be any suitable biometric sensor, including a fingerprint sensor, a facial recognition sensor, an iris or retinal sensor, a voice recognition sensor, or a palm vein sensor. Although described as being included inside or on the auto-injector 2, the biometric sensor 1425 may be, for example, an add-on device or a third-party device.

[0180] The automatic syringe 2 may include a gyroscope 1431. The gyroscope 1431 may include an optical gyroscope or a micro-electromechanical gyroscope and may be used to detect the orientation and / or angular velocity of the automatic syringe 2. In some embodiments, the gyroscope 1431 may be used to detect whether the automatic syringe 2 has been previously rotated and replaced with its original packaging, thereby determining whether the automatic syringe 2 may have been tampered with. As another example, the gyroscope 1431 may be used, for example, to measure the angle and / or orientation of the automatic syringe 2 during the injection sequence. Although described as being included in or on the automatic syringe 2, the gyroscope 1431 may be, for example, an add-on device or a third-party device. The automatic syringe 2 may include an accelerometer 1435. The accelerometer 1435 may include, or take the form of, any suitable accelerometer device, including a micro-electromechanical device, a piezoelectric device, a capacitive device, a piezoresistive device, a servo device, or an optical fiber device. The accelerometer 1435 may be configured to measure or infer the orientation of the user 1449 based on the orientation of the auto-injector 2. Although described as being included in or on the auto-injector 2, the accelerometer 1435 may be, for example, an add-on device or a third-party device.

[0181] Figure 26 provides a high-level, non-exhaustive list of various types of data that the auto-injector 2 may transmit to the mobile device 1407 via a wireless communication module for data tracking and analysis, while Figures 27–50 illustrate exemplary methods of data that the auto-injector 2 and the mobile device 1407 may track. For example, the auto-injector 2 may collect biometric data 1501, patient identification information 1503, temperature data 1505, injection force data 1507, needle depth data 1509, injection data 1511, injection frequency data 1513, charge status 1515, leak data 1517, location data 1519, error status data 1521, and / or inventory data 1523 for the auto-injector 2 and / or cartridge 1302. Furthermore, any of the aforementioned data may be collected by a third-party device, such as a blood pressure monitor, and input into the mobile device 1407. While only a few types of data are shown, any appropriate data may be collected via the auto-injector 2 and / or transmitted to the mobile device 1407. Figure 26 also shows a non-exhaustive list of actions the mobile device 1407 may take, including disabling the auto-injector 2, notifying the healthcare provider (HCP) 1525, notifying the clinical trial administrator 1527, and notifying the user 1529 about the data and various aspects of the data, including trends, inconsistencies, and disparities. For example, data may be collected for in-hospital tracking and statistical analysis and transmitted to the HCP 1525. Alternatively, data may be collected for clinical trial tracking, e.g., participant compliance with a drug dosing plan, and transmitted to the clinical trial administrator 1527. Clinical trial tracking may include, for example, updating a file for a given patient 1447 in real time. In some embodiments, all tracked auto-injectors 2 may be examined, the data aggregated and cross-referenced, and trends analyzed.

[0182] Refer to Figure 27, which shows an exemplary method 2700 for recording patient biometric information. Method 2700 may include step 2702 prompting the user to enter the patient's biometric information into the mobile device 1407 via the mobile device 1407 before, during, or after administering a drug via the auto-injector 2. In one embodiment, Method 2700 may include an optional step 2704 in which the biometric information is measured via a third-party device before being entered. Method 2700 may further include step 2706, which includes recording the biometric information via the mobile device 1407. The biometric information may be recorded by the auto-injector 2 automatically transmitting the biometric information to the mobile device 1407, or by the user manually entering the biometric information into the mobile device 1407. Here, biometric information may include any appropriate biometric information, such as patient identifier; patient demographics; blood pressure; heart rate; patient pain level; body temperature (e.g., at the injection site); patient comfort level; identity of the user who administered the drug to the patient; injection site; patient medication list; blood flow rate; hematological toxicity; blood oxygen saturation; and the progression and symptoms of the patient's disease.

[0183] Patient identifiers may include, for example, appropriate identifiers such as name, date of birth (DOB), age, disease, fingerprints, and facial scan. Patient demographics may include, for example, the patient's age, sex, gender identity, sexual history, education level, address, nationality, ethnicity, marital status, family status, household income, employment status, and / or religion. Blood pressure may include, for example, systolic / diastolic blood pressure measurements. Heart rate may include, for example, heartbeats per minute. Pain level may include any pain scale from 1 to 10 entered by the patient or user via mobile device 1407. Temperature data may include the patient's body temperature (e.g., 98.6 degrees Fahrenheit) or injection site temperature. The patient's body temperature and / or injection site temperature may be collected via the temperature sensor 1437 of the auto-injector 2. Patient comfort level may include the patient's mood (e.g., happy, sad, or anxious) or any comfort level (e.g., a scale from 1 to 10). Patient hesitation may be tracked. The identity of the user who administered the drug to the patient may include, for example, a nurse, doctor, or family member. The injection site may include, for example, the type of injection (e.g., intramuscular or subcutaneous) or the part of the body where the injection was administered (e.g., thigh, abdomen, or shoulder). The patient medication list may include, for example, medications taken by the patient in addition to drugs (e.g., insulin for diabetic patients) and may be cross-referenced by the controller 1408 of the auto-injector 2 and / or the mobile device 1407 for interaction. Blood flow data may include a description or image (taken via the mobile device 1407) of the type or amount of blood flow at the injection site after drug administration. Blood flow data may be collected, inferred, and / or estimated from regularly available data, including, for example, data collected by the mobile device 1407 (e.g., a smartphone, smartwatch, headset, and / or any other medical monitoring device). Depending on the collected blood flow data, HCP1451 and / or clinical trial administrator1453 may determine whether the blood flow is normal (e.g., healthy), abnormal, or pathological. Hematological toxicity data may include the amount of substances in the patient's blood and may include estimates or inferences of hematological toxicity based on the amount of drugs administered and other biological information (e.g., age, weight, medication list, disease progression).Blood oxygen saturation data may include the percentage of oxygen-saturated hemoglobin in the patient's blood. Disease progression in the patient may include appropriate characterization of the patient's disease. For example, disease progression data may include cancer staging (e.g., stages 1-4). In other examples, disease progression may identify other characteristics of the disease, such as early stage, advanced stage, progressive, in remission, or cured. Disease progression in user 1449 may be tracked as a function of treatment (e.g., whether progression slowed or accelerated after treatment). Symptoms may be tracked, for example, for adverse events associated with drug administration. Symptoms may be tracked, for example, via a mobile application on a mobile device 1407.

[0184] Method 2700 may include step 2708, which includes determining whether the biometric information falls within an expected range. The expected range may be, for example, a range predicted by the patient's demographics (e.g., age, weight, etc.), disease progression, or medical history. The expected blood pressure range includes appropriate systolic / diastolic blood pressure measurements, such as, for example, less than 120 mmHg / 80 mmHg, 120-129 mmHg / less than 80 mmHg, 130-139 mmHg / 80-89 mmHg, greater than 140 mmHg / greater than 90 mmHg, greater than 180 mmHg / greater than 120 mmHg. Comparing measured or entered biometric data with expected biometric data may include any appropriate comparison method, including direct comparison, the use of sorting and retrieval algorithms, data hashing, value comparison by relational operators, data visualization tools, and / or various statistical methods including t-tests, ANOVA, correlation coefficients, etc.

[0185] Method 2700 may include any number of actions based on whether the biometric information is within the expected range. For example, Method 2700 may include an alternative step 2710a, which includes notifying the user via a mobile device that the biometric information is outside the expected range, including whether incorrect biometric information was entered, based on whether the biometric information is within the expected range. Another example is that if the progression of the disease exceeds a predetermined threshold, or if a predetermined injection site has been used too many times, Method 1000 may include recommending a new injection site. Method 1000 may include analyzing the biometric information for trends using a machine learning algorithm and notifying the user of the trends via a mobile device 1407. Step 2710a may include disabling the auto-injector 2 by disabling the fluid conduit 300 of the auto-injector 2 from being in a deployed configuration related to drug administration.

[0186] Method 2700 may include, as an alternative step 2710b, transmitting biometric information to an HCP or clinical trial administrator. Transmission of biometric information may include transmitting biometric information via a remote server or any suitable data transmission method (e.g., NFC, Bluetooth, WiFi, cellular modem, or satellite).

[0187] In some embodiments, the mobile application may be configured to authenticate the user of the auto-injector 2 before use. For example, the mobile application may verify the user's identity before injection using biometric authentication, two-factor authentication, or other appropriate authentication protocol in relation to the user's mobile device. Depending on the user's authentication, the mobile application may activate or unlock the auto-injector. Such user authentication can deter misuse and / or waste of expensive medication by anyone other than the intended or authorized user.

[0188] Figure 28 shows an exemplary method 2800 for verifying a patient's identity. Method 2800 includes step 2802, which includes prompting the user to enter patient identification information before administering a drug via the auto-injector 2 or via the mobile device 1407. Here, the user may be the patient or a third party (e.g., a nurse, doctor, or family member). The patient identification information may include any appropriate patient identifier (e.g., name, DOB, age, fingerprint, facial scan, etc.) as previously stated. The user may enter the patient identifier via the mobile device 1407, for example, by entering the identifier into the mobile device 1407. Alternatively, the user may verify the patient's identity using the biometric sensors 1425 of the mobile device 1407, such as a fingerprint scanner and / or facial scanner. Method 2800 may also include an optional step of recording or logging the entered patient identification information for future reference.

[0189] Method 2800 may include step 2806, which includes comparing the entered patient identification information with expected patient identification information. Expected patient identification information may include predetermined identification data such as the patient's name, DOB, and / or a unique patient identification number, a QR code, and / or a barcode associated with patient 1447 (e.g., on a medical bracelet). In some embodiments, the HCP may remotely set the expected patient identifier. In other embodiments, the expected patient identifier may be set by the user or patient to prevent others from operating the auto-injector 2. In yet another embodiment, the user 1449 or HCP 1451 may assign the auto-injector 2 to a given patient 1447 by scanning a QR code or barcode. Patient 1447 may then have to scan a QR code or barcode associated with that patient 1447 in order to use the auto-injector 2.

[0190] Method 2800 may include step 2808a, which involves initiating drug administration based on a comparison of entered patient identification information with patient identification information compared to that patient identification information. That is, once the patient's identity is confirmed, the auto-injector 2 may initiate its administration sequence.

[0191] Method 2800 may include an alternative step 2808b, which includes disabling the auto-injector 2 based on a comparison of entered patient identification information with patient identification information compared. Step 2808b may include disabling the auto-injector 2 by disabling the fluid conduit 300 of the auto-injector 2 from being in an deployed configuration related to drug administration.

[0192] Figure 29 shows an exemplary method 2900 for collecting data related to the temperature of a patient's injection site. Step 2902 may include receiving measured temperature data (e.g., thermal radiation of the injection site) from the auto-injector 2 to the patient's injection site in the auto-injector 2. The temperature data may be measured via a temperature sensor (e.g., thermometer 1437) on the housing 3 of the auto-injector 2.

[0193] Method 2900 may include step 2904, which involves comparing measured temperature data with expected temperature data. Step 2904 may include comparison methods described herein, such as direct comparison, statistical comparison, and the like.

[0194] Method 2900 may include step 2906a, which includes notifying the user of the temperature data based on a comparison of the temperature data with the expected temperature data. If the temperature data is equal to or near the threshold temperature, Method 2900 may include doing nothing. If the temperature data exceeds the threshold temperature, Method 2900 may include starting the cooling system, opening a valve to release the hot fluid, triggering an alarm or warning light, cutting off power to some or all of the autosyringer 2, activating the heat sink, or disabling and / or powering down the autosyringer 2. If the temperature data is below the threshold temperature, Method 2900 may include activating the heating system (e.g., the heat element 1429), closing a valve to retain heat and / or preventing the ingress of cold fluid, triggering an alarm and / or warning light, increasing power to the components of the autosyringer 2 and / or disabling or powering down the autosyringer 2. Temperature data can be measured in real time while the drug is being administered through the automatic injector 2. Furthermore, notifying the user may include notifying the user of the device's temperature in real time.

[0195] Method 2900 may include step 2906b, which includes transmitting temperature data to a healthcare provider or clinical trial administrator via a wireless communication module of a mobile device. The transmission of temperature data may include transmitting biometric information via any suitable data transmission method of a remote server or mobile device 1407 (e.g., NFC, Bluetooth, WiFi, cellular modem, or satellite).

[0196] Figure 30 shows an exemplary method 3000 for notifying a user of excessive swelling at an injection site. Method 3000 may include step 3002, which includes receiving swelling data at the patient's injection site. This may be received in real time (e.g., while the auto-injector is dispensing the drug) or at any time thereafter. The swelling data may include data related to the temperature and / or curvature of the injection site, for example, via a pressure sensor. An increase in the temperature of the injection site may indicate, for example, an increase in blood flow to the injection site due to swelling.

[0197] Method 3000 may include step 3004, which includes comparing the measured swelling data with an expected swelling data range. Step 3004 may include comparison methods described herein, e.g., direct comparison, statistical comparison, etc. Method 3000 may include step 3006a, which includes notifying the user and / or patient of the swelling data based on a comparison of the measured swelling data with an expected swelling data range. The notification may include a summary of the swelling data, trends, discrepancies and / or differences between the measured data and the expected data. For example, the notification may show the user 1449 the temperature at the injection site. The notification may include audio feedback or a visual warning (e.g., a notification on a mobile device 1407). Method 3000 may include step 3006b, which includes transmitting the swelling data to an HCP or clinical trial administrator. Transmitting the swelling data may include wirelessly transmitting the swelling data to a computing device of an HCP or clinical trial administrator.

[0198] In further embodiments, if swelling data indicates severe swelling, method 3000 may also include disabling the auto-injector 2 despite the user attempting to use it. Disabling the auto-injector 2 may include the mobile device controller disabling the configuration in which the fluid conduit of the auto-injector is deployed.

[0199] Figure 31 shows an exemplary method 3100 for comparing injection force data of an auto-syringe 2. Method 3100 may include step 3102, which includes receiving injection force data from the auto-syringe 2, collected through a sensor 1427 on the housing 3 of the auto-syringe 2. The injection force data may be measured, for example, through the sensor 1427 of the auto-syringe 2.

[0200] Method 3100 may include step 3104, which involves comparing injection force data with expected injection force data using a controller 1455 of a mobile device 1407. Step 3104 may include comparison methods described herein, such as direct comparison or statistical comparison.

[0201] Method 3100 may include step 3106a, which includes notifying the user of the auto-injector 2 of any discrepancy between the injection force data and the expected injection force data, based on a comparison of the injection force data with the expected injection force data. The notification may be made via any suitable means considered herein, e.g., text notification, voice feedback, etc. The notification may include, for example, a table containing past injection force data points having the injection force of the last injection (e.g., 1 megapascal (MPa), 2.5 MPa, 4 MPa, 6 MPa, etc.), the amount of drug injected, and / or the corresponding injection site. Method 3100 may optionally include giving the user the option to log the injection force data for further analysis and / or record keeping. Notifying the user of the auto-injector 2 of the compared injection force data may further include, for example, recommending a different injection site to the patient. This recommendation may be made via any suitable means, including text or voice guidance. In some embodiments, the recommendation may include displaying instructions on a mobile device 1407 to guide the patient and / or user to a different injection site.

[0202] Method 3100 may include step 3106b, which involves transmitting injection force data to an HCP or clinical trial administrator via a wireless communication module 1415 of a mobile device 1407, based on a comparison of injection force data.

[0203] Figure 32 shows an exemplary method 3200 for measuring needle depth data during injection. Method 3200 may include step 3202, which includes receiving needle depth data relating to the depth to which the needle 306 of the auto-injector 2 penetrates the user's injection site. The needle depth data may be collected while administering a drug using the auto-injector 2. Step 3202 may also include, for example, measuring the angle at which the injection needle 306 is inserted into the injection site.

[0204] Method 3200 may include step 3204, which involves comparing needle depth data with expected needle depth data via a controller 1455 of a mobile device 1407. Step 3204 may include comparison methods described herein, such as direct comparison or statistical comparison. Expected needle depth data may vary depending on the type of injection (e.g., subcutaneous or intramuscular). For subcutaneous injections, expected needle depth data may range from less than 6 millimeters (mm) to about 13 mm. For intramuscular injections, expected needle depth data may range from less than 16 mm to about 25 mm, depending on the patient's age. For example, if the needle depth is below a threshold (e.g., the needle 306 does not penetrate deeply enough into the injection site) or above a threshold (e.g., the needle 306 penetrates too deeply into the injection site), the mobile device 1407 may notify the user 1449 of the injection error or failure, terminate the injection, automatically retract the needle 306, display a notification to change the needle 306, recommend a new injection site, and / or disable the auto-injector 2. The notification may include injection depth data points or a table of past injection depth data points with corresponding injection sites.

[0205] Method 3200 may include step 3206 of notifying the user 1449 of the injection depth data based on a comparison of the needle depth data with the expected needle depth data. In one embodiment, Method 3200 may include an optional step 3208a of recommending a new injection site to the user if the needle depth data is too high or too low. Method 3200 may optionally include modifying the length of time the needle 306 protrudes from the housing 3 of the auto-injector 2 while the drug is being injected. For example, the amount of time the needle 306 protrudes from the housing 3 may be increased or decreased depending on the amount the carrier 202 slides between a first position and a second position.

[0206] Method 3200 may include step 3208b, which involves transmitting needle depth data to an HCP or clinical trial administrator via a wireless communication module 1415 of a mobile device 1407.

[0207] Injection data

[0208] Figure 33 shows an exemplary method 3300 for comparing injection data from an auto-syringe 2. Method 3300 may include step 3202, which includes receiving injection data from the auto-syringe 2 on a mobile device 1407. The injection data may include at least one of the bolus size and the injection rate. The bolus size may be estimated, for example, by the amount the piston 1316 is pushed down in the cartridge 1302. The injection data may also include the length of the needle over time (for example, the needle 306 may become dull or shorter with use). Method 3300 may include step 3304, which includes comparing the injection data with expected injection data. Step 3304 may include the comparison methods described herein, e.g., direct comparison, statistical comparison, etc.

[0209] Method 3300 may include an optional step 3306, which involves analyzing injection data for trends using a machine learning algorithm. The trends may be displayed, for example, on a mobile device 1407, so that the user or patient can view them.

[0210] Method 3300 may include steps 3308a to 3308c, which are results based on a comparison of injection data. Step 3308a may include notifying the user of the auto-injector 2 of any discrepancy between the injection data and the expected injection data. For example, if too little or too much medication is administered, the user 1449 may be notified via voice feedback from the auto-injector 2 or via the mobile device 1407. Step 3308b may include disabling the auto-injector 2 despite the user attempting to use it. Disabling the auto-injector 2 may include the controller 1455 of the mobile device 1407 disabling the configuration in which the needle 306 of the auto-injector 2 is deployed. Step 3308c may include transmitting the injection data to the HCP 1451 or clinical trial administrator 1453 via the wireless communication module 1415 of the mobile device 1407.

[0211] Figure 34 shows an exemplary method 3400 for comparing injection frequency data. Method 3400 may include step 3402, which includes receiving injection frequency data from auto-injector 2 on a mobile device 1407. Auto-injector 2 may be a single-use (e.g., disposable) device. Injection frequency data may include at least one of the date and time of injection. Injection frequency data may rely on historical injection data that has been automatically recorded based on previous injections by user 1449. For example, user 1449 may require authentication to activate auto-injector 2, and if the injection is successful, the auto-injector 2 mobile application may automatically update user 1449's profile to indicate the success of the injection. A predetermined time may be set for the next injection, and auto-injector 2 may only be activated within a predetermined window. Furthermore, auto-injector 2 may only be activated after a minimum time (e.g., 24 hours) has elapsed since the last injection.

[0212] Method 3400 may include step 3404, which involves comparing injection frequency data with expected frequency data via a mobile device 1407, based on the comparison of injection frequency data with expected frequency data. Step 3404 may include comparison methods described herein, e.g., direct comparison, statistical comparison, etc. Expected injection frequency data may include, for example, how a drug dosing plan is provided by the HCP or drug manufacturer. For example, the expected injection frequency of a drug may be multiple times a day, daily, weekly, or any combination thereof. Method 3400 may include step 3408a, which involves notifying the user of the auto-injector 2 of the next dose via the mobile device 1407, e.g., notifying the user of the upcoming scheduled injection date and time. The notification may also, or alternatively, include a table of historical data including date, time, injection site, amount of drug administered, and / or other appropriate information. Method 3400 may further include an optional step 3410a, which involves adding a calendar appointment on the mobile application of the mobile device 1407. In some embodiments, such appointments may be automatically scheduled on a mobile application on a mobile device 1407 for the next expected injection. In yet another embodiment, frequency data may be used to determine the time when patient 1447 is scheduled to receive the medication. In such embodiments, method 3400 may include notifying user 1449 of the time to take the medication. In yet another example, method 3400 may include notifying user 1449 of the time to remove the medication from the refrigerator to warm it before use.

[0213] Alternatively, or in addition, Method 3400 may include step 3408b, which includes notifying the user of any discrepancy between injection frequency data and expected injection frequency data. The notification may, for example, be displayed on a mobile device 1407 indicating that the user has been administered the drug outside the expected injection frequency range, for example, that too little or too much of the drug has been administered over a given period (e.g., days, weeks, or months). Method 3400 may also include step 3408b, which includes transmitting the injection frequency data to at least one of the HCP and the clinical trial manager.

[0214] Figures 35 and 36 show exemplary methods 3500 and 3600 for comparing temperature data received from an auto-injector 2. Method 3500 may include step 3502, which includes receiving temperature data from the auto-injector 2. The temperature data may be measured by at least one temperature sensor (e.g., thermometer 1437) coupled to the housing 3 of the auto-injector 2. Method 3500 may include step 3504, which involves comparing the temperature data with expected temperature data to determine whether the drug is at a predetermined threshold temperature. Step 3504 may include comparison methods described herein, such as direct comparison, statistical comparison, and the like.

[0215] Method 3500 may include a number of modification actions depending on the comparison in step 3504. In some embodiments, if the drug must be kept below a threshold temperature, e.g., a low temperature, Method 3500 may include continuously monitoring the temperature of the drug. If the temperature approaches or exceeds a first threshold but is still within a predetermined temperature range safe for administration, Method 3500 may include sending an alert to the user 1449, HCP 1451, etc. If the temperature of the drug exceeds a second threshold for a period of time exceeding the threshold, the syringe may be rendered unusable. Method 3500 may include step 3506a, which includes notifying the user of the auto-injector of the temperature data via a mobile device 1407 based on a comparison of the temperature data with expected temperature data. Alternatively, or in addition, Method 3500 may include step 3506b, which includes initiating a warming sequence for the drug. Step 3506b may be automatic (e.g., without user intervention) or based on user input.

[0216] Referring here to Figure 36, Method 3600 may include warming the drug with a heating element 1429 adjacent to the cartridge 1302 or vial containing the drug within the housing 3 of the auto-injector 2. Method 3600 may include step 3604, which includes displaying the temperature of the drug in real time via a mobile device 1407 as the drug warms up to a predetermined threshold temperature. The mobile device 1407 may further display an estimated remaining time until the drug warms up to the predetermined threshold temperature. In some embodiments, Method 3600 may further include disabling the auto-injector 2 based on a command from the mobile device 1407 sent to the controller 1408 of the auto-injector 2. The command may disable the drug injection function of the auto-injector 2.

[0217] Figure 37 shows an exemplary method 3700 for comparing administration rate data. Method 3700 may optionally include step 3702, which includes administering a drug using an auto-injector 2. Method 3700 may include step 3704, which includes receiving administration rate data from the auto-injector 2 during or after administering the drug using the auto-injector 2. The administration rate data may include the amount of drug delivered to the patient per unit time (e.g., milliseconds, seconds, minutes). Method 3700 may include step 3706, which includes comparing the administration rate data with expected administration rate data. Step 3704 may include comparison methods described herein, such as direct comparison, statistical comparison, etc.

[0218] Method 3700 may include step 3708, which involves changing the injection rate of a drug by sending a command from the mobile device 1407 to the auto-injector 2 to the motor in the piston 1316 of the auto-injector to change the speed at which the piston 1316 moves through the cartridge 1302 containing the drug, based on a comparison of the infusion rate data with the expected infusion rate data. Changing the injection rate may include decreasing or increasing the injection rate, or doing nothing if the infusion rate data is within the expected range. In some embodiments, Method 3700 may include using the mobile device 1407 to recommend a new injection site to the user based on whether the infusion rate data is below a threshold of the expected infusion rate data. For example, if the infusion rate data is below a threshold of the expected infusion rate data, the controller 1408 of the auto-injector 2 may infer that the injection site is, for example, callous or too swollen and recommend an alternative injection site to the user.

[0219] Figure 38 shows an exemplary method 3800 for verifying that a patient is complying with instructions for use (IFU). Method 3800 may include step 3802, which includes, for example, displaying the IFU on a mobile device 1407. Method 3800 may include step 3804, which includes receiving compliance data on the mobile device 1407 while administering the drug to the user using an auto-injector 2. Compliance data may include the user's adherence to prescribed instructions for use related to the administration of the drug, for example, a drug administration treatment plan provided by an HCP. Compliance data may include the frequency of injections, the date and time of injections, whether the patient 1447 was injected at a prescribed time or within a prescribed date and / or the amount of drug administered. Where appropriate, compliance data may be automatically logged and / or automatically sent to an HCP 1451 or a clinical trial administrator 1453. Alternatively, Method 3800 may include prompting the user 1449 to enter into the mobile device 1407 whether the patient 1447 has complied with the drug administration treatment plan.

[0220] Method 3800 may include step 3806, which includes comparing compliance data with instructions for use. Step 3304 may include comparison methods as described herein, e.g., direct comparison, statistical comparison, etc. Method 3800 may include steps 3808a to 3808c, which are actions taken based on the comparison of compliance data with instructions for use. Step 3808a may include displaying a non-compliance warning on the mobile device 1407. Step 3808b may include displaying IFUs on the display of the mobile device 1407 so that the patient and / or user can follow them while the drug is being administered to the user using an auto-injector. Alternatively, or in addition, step 3808c may include transmitting compliance data to at least one of the HCP or clinical trial administrator. Alternatively, or in addition, method 3800 may include disabling the auto-injector 2 by sending a command from the controller 1455 of the mobile device 1407 to disable the auto-injector 2 from being in a deployed configuration, based on comparison. For example, if too many injections are recorded in a short period of time, or if too much medication is administered in a short period of time, the auto-injector 2 may be disabled to prevent toxicity in the patient 1447.

[0221] Figure 39 shows an exemplary method 3900 for comparing the charge state of the battery of the auto-syringe 2. Method 3900 may include step 3902, which includes receiving the charge state of the battery of the auto-syringe 2. The charge state may be received by any suitable method, including wired or wireless communication between the auto-syringe and the mobile device 1407. The charge state may be measured by measuring the current entering and leaving the battery, the battery voltage, and / or the battery temperature.

[0222] Method 3900 may include step 3904, which includes comparing the charge state of a battery with a predetermined threshold. Step 3904 may include comparison methods described herein, such as direct comparison, statistical comparison, and the like.

[0223] Method 3900 may include step 3906, which involves calculating the remaining battery life of the battery of the auto-injector 2. The remaining battery life of the battery may include using the Coulomb counting method, the open-circuit voltage method, and / or a Kalman filter.

[0224] Method 3900 may include steps 3908a and 3908b, each including an action taken based on the comparison in step 3906. Step 3908b may include displaying a warning on a mobile device indicating that the charge level of the auto-syringe battery is below a predetermined threshold, if the charge level is below a predetermined threshold. This warning may include, for example, an instruction to plug a charger into the auto-syringe 2. Method 3900 may further include displaying the charge level and the estimated remaining time until charging is complete in real time on, for example, a mobile device 1407.

[0225] Figure 40 shows an exemplary embodiment 4000 of providing audio or flashing light feedback from the auto-injector 2. Method 4000 may include step 4002, which includes measuring drug-related data. Drug-related data may include any appropriate data, including expiration date, lot information including lot number, serialization via QR code including component ID, manufacturer, volume level of drug in cartridge 1302, success / failure of injection, whether the needle 306 is broken, or drug temperature. Step 4002 may be completed before, during, or after administration of the drug. Method 4000 may include step 4004, which includes comparing the drug-related data with an expected data range for the drug. Method 4000 may include step 4006, which includes providing audio feedback via the speaker of the auto-injector 2 and / or flashing light on LED 52, based on the comparison in step 4004. The audio or flashing light feedback may be provided for any appropriate reason, including detection of an error condition in the auto-injector 2 or success / failure of injection. In some embodiments, the voice feedback may include an audible message indicating “injection complete” or “injection failed.” Method 4000 may include an optional step 4008 which includes lowering the volume of the voice feedback or disabling a flashing light.

[0226] Figure 41 shows an exemplary method 4100 for detecting a leak in an auto-syringe 2. Method 4100 may include step 4102, which includes detecting a leak of a drug from a vial or cartridge 1302. The leak may be detected by a suitable method, for example, an optical sensor, pressure sensor, flow sensor, or temperature sensor in the auto-syringe 2. The leak may be detected by detecting a sudden temperature change, chemical change, etc. If a leak is detected, Method 4100 may include step 4104, which includes transmitting leak data to a mobile device 1407. Method 4100 may include steps 4106a and 4106, which take action in response to the detected leak. For example, step 4106a may include disabling the auto-syringe 2 by disabling the needle 306 of the auto-syringe 2 from being in a deployed configuration in response to the detection of a leak. Step 4106b may include notifying the user that a leak has occurred in the auto-syringe 2, for example, by displaying a warning via a mobile device 1407.

[0227] Figure 42 shows an exemplary method 4200 for verifying the inventory history of an auto-injector 2 or a drug. Method 4200 may include step 4202, which includes receiving device identification data related to at least one of the drug in the cartridge 1302 of the auto-injector 2 or the auto-injector 2 itself. The identification data may include serialization via a QR code including a serial number, batch number, lot number, or component ID, manufacturer, drug identifier (e.g., name), inventory management unit (SKU), reorder point, or any appropriate identifier including a barcode.

[0228] Method 4200 may include step 4204, which includes retrieving inventory data associated with device identification data from a remote server. The relevant inventory data may include update information related to, for example, lot number or batch number of the auto-injector 2 or cartridge 1302. For example, if there is a manufacturer recall for either the auto-injector 2 or cartridge 1302, that information is retrieved from the remote server. Step 4202 may be completed, for example, by a mobile device 1407. Step 4202 may be completed automatically (for example, without user input) or manually. In some embodiments, Method 4200 may include collecting inventory data relating to the personal inventory supplies of user 1449. In such cases, if the inventory data falls below a threshold, Method 4200 may include ordering and / or replenishing the personal inventory of user 1449. This may be done manually, by soliciting input from user 1449 via a mobile application on mobile device 1407, or automatically at the time of the last dose. In other embodiments, the acquired inventory data may include the number of cartridges 1302 and / or auto-injectors 2 in stock at a given location (e.g., a pharmacy, a manufacturer's warehouse, or a healthcare provider's premises). When inventory is low or completely depleted, Method 4200 may include automatic replenishment at the location where the inventory was depleted. For example, if the number of auto-injectors 2 and / or cartridges 1302 falls below a threshold, Method 4200 may include automatically sending a replenishment order to the manufacturer of auto-injectors 2 and / or cartridges 1302. The inventory data may also be used to determine sales data and / or market share in a given region. For example, the market share of the manufacturer of auto-injectors 2 and / or cartridges 1302 can be estimated based on how often the inventory is depleted.

[0229] Method 4200 may include comparison steps 4206a and 4206b. Step 4206a includes comparing the received inventory data with recall data. If a recall is issued for either the auto-injector 2 or the cartridge 1302, Method 4600 may proceed to step 4208a, which includes displaying a warning to the user on the mobile device 1407. Alternatively, or in addition, step 4202b may include comparing the received inventory data with the expiration dates associated with the auto-injector 2 and / or the cartridge 1302. If step 4202b determines that the auto-injector 2 and / or the cartridge 1302 have expired, Method 4200 proceeds to step 4208b, which includes displaying a warning on the mobile device 1407. The warning may include, for example, a past expiration date and a statement to discontinue use of the drug, or recall information including the date the recall was issued, the manufacturer, and the nature of the recall (e.g., contaminated drug). In any situation, method 4200 may include step 4210, which includes, based on comparison, disabling the needle 306 of auto-injector 2 from being in a deployed configuration. Auto-injector 2 may be disabled, for example, by the controller 1455 of mobile device 1407 sending a command to the controller 1408 of auto-injector 2. Alternatively, or in addition, method 4200 may include purchasing more medication and / or auto-injectors 2, for example via mobile device 1407, to replace expired and / or recalled medication or auto-injectors 2.

[0230] Figure 43 shows an exemplary method 4300 for locating the auto-syringe 2. Method 4300 may include step 4302, which includes requesting the location of the auto-syringe 2 via a mobile device 1407. For example, if the auto-syringe 2 is spatially distant from the user, the user may attempt to locate the auto-syringe 2 by geolocation tracking. In some embodiments, the user can track the location of the auto-syringe 2 using an indoor positioning system (e.g., a WiFi module 1419 and / or a Bluetooth module 1457) and / or a GPS module 1461. The location may also be determined remotely by the user via the mobile device 1407 after enabling audible feedback through the speaker of the auto-syringe 2.

[0231] Method 4300 may include step 4304, which involves receiving a position signal associated with the auto-injector 2 and transmitted via the auto-injector 2's wireless communication module. The auto-injector 2 may determine its own position using its wireless communication module 1411.

[0232] Method 4300 may include step 4306, which includes displaying the location of the auto-syringe 2 on the display of the mobile device 1407. Displaying the location may include, for example, displaying a notification or map display of the location of the auto-syringe 2 to the mobile device 1407. The location may be displayed in real time, or a table and / or map of past locations may be displayed. In some embodiments, location data may be used to verify or predict the identity of the user 1449. For example, if the location of the auto-syringe 2 is expected to be in one place, but the location data reveals that the auto-syringe 2 is in another distant location, the mobile device 1407 may notify the user 1449 and / or disable the auto-syringe 2. In other embodiments, Method 3400 may include disabling the auto-syringe 2 if it is too far from the mobile device 1407. In another example, method 4300 may include disabling the auto-syringe based on its proximity to another auto-syringe 2, for example, to protect against accidental use by an incorrect user. Disabling the auto-syringe 2 may be completed manually by the user 1449 by inputting into the mobile device 1407, or it may be completed automatically by the mobile device 1407. In such an embodiment, the controller 1408 of the auto-syringe 2 may disable the auto-syringe 2 from being in a deployed configuration.

[0233] Figure 44 shows an exemplary method 4400 for correcting an error condition of the auto-injector 2. Method 4400 may include step 4402, which includes receiving error data related to the error condition of the auto-injector 2 via a mobile device 1407. The error data may include at least one of the type, date, or time related to the error condition, and the amount of medication administered to the user via the auto-injector regardless of the error condition. The type of error may be any type of failure, including needle deployment failure, mechanical failure, trigger mechanism failure, dosage failure (e.g., under- or over-dosing), type of medication failure, design defect of the auto-injector 2, and / or battery failure. The error data may include whether the error of the auto-injector 2 includes a complete or partial failure of the auto-injector 2 to administer medication to the user.

[0234] Method 4400 may include any steps 4404a to 4404c, which include: step 4404a: recording a date and time error; step 4404b: recording whether the error condition is correctable (e.g., whether the user corrects the error condition or whether the error condition is fatal to the auto-injector 2); and step 4404c: recording the amount of drug administered despite the error condition.

[0235] Method 4400 may include step 4406, which involves comparing error data with known error types, for example, to determine the correctability of an error condition, using any suitable comparison method described herein.

[0236] Method 4400 may include corrective steps 4408-4412. Step 4408 includes notifying the user of the error condition by displaying a notification on the mobile device 1407 based on a comparison of the error data with known error types. The notification may include error data (e.g., type of error, date, or time) and / or instructions for corrective action. For example, instructions for corrective action may include restarting the auto-injector or re-injecting at a different injection site. If correctable, Method 4400 may include step 4410, which includes displaying corrective steps that the user should take to correct the error condition. This may be, for example, a list of steps to be followed to correct the error condition. Method 4400 may include step 4412, which includes encouraging the user to contact the manufacturer for assistance and / or to file a complaint. If the error condition is not correctable, Method 4400 may include disabling the automatic injector 2's needle 306 from being in a deployed configuration via the controller 1455 of the mobile device 1407. Complaints can be submitted, for example, through a mobile application on a mobile device 1407.

[0237] Figure 45 shows an exemplary method 4500 for detecting whether an auto-syringe 2 has been tampered with. Method 4500 may include step 4502, which includes detecting tampering data associated with the auto-syringe 2 using at least one sensor associated with the auto-syringe 2. Tampering data may be generated by a tampering switch, e.g., a physical switch that detects whether the housing 3 of the auto-syringe 2 has been opened; optical tampering detection including an optical sensor that detects whether the auto-syringe 2 has been opened; an integrated circuit designed to detect unauthorized access to the auto-syringe 2; an accelerometer 1435 and / or gyroscope 1431 that detects changes in motion or orientation; and a magnetic sensor that detects changes in the magnetic field. For example, detecting tampering data associated with the auto-syringe 2 may include determining whether the housing 3 has been opened. In another example, Method 4500 may include verifying whether the drug in the auto-syringe 2 has been tampered with.

[0238] Method 4500 may include step 4504, which includes comparing detected tampered data with expected tampered data. Expected tampered data may include a desired state in which the auto-syringe 2 is not tampered with. Expected tampered data may also include known types of tampering, such as the housing 3 being open. If tampering is identified, Method 4500 may include disabling the configuration in which the needle 306 of the auto-syringe 2 is deployed via the controller 1455 of the mobile device 1407.

[0239] Figure 46 shows an exemplary method 4600 for displaying data related to data collected via the auto-injector 2. Method 4600 may include step 4602, which includes receiving data related to the administration of the auto-injector 2 and / or the drug. The data related to the auto-injector 2 may be any data, including the data described herein (e.g., temperature data, error status, charge status, etc.). Method 4600 may include step 4604, which includes analyzing the data related to the auto-injector. Method 4600 may include steps 4606a and 4606b for dealing with the analyzed data. For example, step 4606a displays the analyzed data in one of the following on a mobile device 1407: chart, graph, spreadsheet, etc. Alternatively, or in addition, step 4606b may include prompting the user to send the information to an HCP or clinical trial administrator.

[0240] Figure 47 shows an exemplary method 4700 for detecting the strength of an adhesive associated with an auto-injector 2, for example, an adhesive patch 2. Method 4700 may include step 4702, which includes detecting the adhesive strength of the adhesive in the auto-injector 2. Step 4704 includes comparing the adhesive strength to a known value, and step 4706 may include notifying the user via a mobile device 1407, for example, the adhesive strength, a table of past adhesive strengths, and / or a recommendation with instructions to change the adhesive in the auto-injector 2.

[0241] Figure 48 shows an exemplary method 4800 for determining the type and dosage of medication in an auto-injector 2. Method 4800 may include step 4802, which includes determining the type and dosage of medication by scanning an identifier on the cartridge 1302 of the auto-injector 2. The scan may be performed with any third-party camera, for example, a camera built into a mobile device 1407. Step 4804 includes comparing the type and dosage of medication with the expected type and dosage of medication for the patient to which the auto-injector 2 is associated. Based on the comparison in step 4802, method 4800 may proceed to step 4806a or step 4806b. For example, if the type of medication is not the expected type of medication for a given patient, or if the dosage is an incorrect dosage, method 4806a proceeds to step 4806b, which includes displaying a warning on the mobile device 1407 associated with the auto-injector 2 and / or disabling the auto-injector 2.

[0242] Figure 49 shows an exemplary method 4900 for encouraging adherence to a drug administration treatment plan. The drug administration treatment plan may be prescribed by an HCP along with medications delivered by an auto-injector 2. Accordingly, method 4900 may include step 4902, which involves tracking injection data associated with the auto-injector 2. The data may be tracked, for example, via a mobile application on a mobile device 1407. Method 4904 may include analyzing the injection data for trends over a period of time. For example, data may be analyzed for daily injections prescribed by an HCP. Depending on the data and trend analysis, method 4900 may proceed to steps 4906a to 4906c. Step 4906a includes displaying trend and / or motivational quotes on the mobile device 1407 to encourage adherence to the drug administration treatment plan. Injection compliance may be gamified. Based on the trend analysis, if the patient is adhering to the drug administration treatment plan, the mobile application on the mobile device 1407 may provide the patient with an incentive. Other embodiments may include posting online leaderboards and / or injection statistics. Incentives may include, for example, monetary rewards, cryptocurrency, discounts on future drug purchases, and / or digital badges. Alternatively, or in addition thereto, step 4906c may include submitting injection data to an HCP or clinical trial administrator for review or placement in the patient's medical file.

[0243] Figure 50 shows an exemplary method 5000 corresponding to a patient's mental state related to the administration of a drug by an auto-injector 2. Method 5000 may include step 5002, which includes detecting the patient's mental state. This may include entering the patient's mental state into a mobile application on a mobile device 1407. The mental state may include, for example, happiness, sadness, worry, tension, anxiety, etc. Alternatively, or in addition, the mental state may be on any scale from 1 to 10 based on the patient's concerns about receiving the drug. Method 5000 may include step 5004, which includes comparing the patient's mental state to an expected or expected acceptable range of mental states. If the patient's mental state is outside the expected range, step 5006 may include, for example, delaying the administration of the drug to allow the patient to calm down.

[0244] It should be understood that one or more steps of the various methods described herein may be combined in particular embodiments. Furthermore, in particular embodiments, fewer steps than all of the steps of the methods described herein may be performed, and / or additional steps not described herein may be performed. Moreover, the steps described herein do not necessarily have to be performed in the exact order presented.

[0245] In particular, the reference to "one embodiment" or "an embodiment" in this specification means that the specific features, structures, or characteristics described in relation to the embodiment can be included, adopted, and / or incorporated into one, some, or all of the embodiments of the present disclosure. The use or occurrence of the phrases "in one embodiment" or "in another embodiment" in this specification does not refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of one or more other embodiments, nor are they limited to a single exclusive embodiment. The same applies to the terms "embodiment" and "example". The present disclosure is not limited to a single aspect or its embodiment, or any combination and / or substitution of aspects and / or embodiments. Furthermore, each of the aspects and / or embodiments of the present disclosure may be used alone or in combination with one or more of the other aspects and / or embodiments of the present disclosure. For the sake of brevity, specific substitutions and combinations are not individually discussed and / or illustrated in this specification.

[0246] Furthermore, as indicated above, embodiments or implementations described as "exemplary" in this specification should not be construed as, for example, more preferable or advantageous than other embodiments or implementations, but rather are intended to convey or indicate that the embodiment(s) is / are "exemplary" embodiment(s).

[0247] The present disclosure is further illustrated by the following non-limiting clauses.

[0248] <Clause 1. An autoinjector, comprising: a housing; a cartridge disposed within the housing, the cartridge containing a drug; a fluid conduit configured to deliver the drug from the cartridge to a patient and movable from a stored configuration associated with administration of the drug to a deployed configuration; a temperature sensor configured to measure the temperature of the drug; and a controller coupled to the temperature sensor, the controller being configured to transmit a first signal to an external device when the temperature sensor senses that the temperature of the drug has risen above a first threshold temperature.

[0249] Clause 2. The autoinjector according to claim 1, wherein the first threshold temperature is less than the minimum safe temperature for the drug.

[0250] Clause 3. The autoinjector according to claim 1, wherein the first signal causes the external device to display a warning.

[0251] Clause 4. The autoinjector according to claim 3, wherein the controller is configured to transmit a second signal when the temperature of the drug drops below the threshold temperature after rising above the threshold temperature.

[0252] Clause 5. The autoinjector according to claim 4, wherein the second signal cancels the warning on the external device.

[0253] Clause 6. The autoinjector according to claim 1, wherein the controller is configured to prevent initiation of injection by the autoinjector when the temperature of the drug rises above a second threshold temperature that is higher than the first threshold temperature.

[0254] Clause 7. The autoinjector according to claim 6, wherein the second threshold temperature is the minimum safe temperature of the drug.

[0255] Clause 8. Further comprising a plunger coupled to the housing and movable relative to the housing, and one or more electronic components used during injection performed by the automatic syringe, the one or more electronic components formed within an electrical circuit, wherein in a first configuration, a first portion of the plunger is located within the housing, the electrical circuit is open, and the one or more electronic components are in a low-power sleep mode; in a second configuration, the plunger moves outward relative to the housing, the first portion of the plunger extends outward from the housing, and in the second configuration, the electrical circuit is closed, and the one or more electronic components are in a low-power sleep mode; The automatic syringe according to claim 7, wherein the sub-device component transitions from the low-power sleep mode to an active mode, the plunger is movable from the second configuration toward the housing to a third configuration, and unless otherwise instructed by the controller, the automatic syringe is configured to initiate injection by the automatic syringe only after the plunger has been moved toward the third configuration and one or more electronic components are in the active mode, and if the drug rises above the second threshold temperature, the automatic syringe is configured to prevent the initiation of injection by the automatic syringe after the plunger has been moved toward the third configuration.

[0256] Clause 9. The automatic syringe according to claim 1, wherein the controller is configured to continuously transmit temperature data of the drug to the external device.

[0257] Clause 10. The auto-injector according to claim 1, further comprising a thermal element connected to the controller and adjacent to the cartridge, wherein the controller is configured to selectively raise the temperature of the drug based on input provided by a user via a mobile device communicating with the auto-injector via the thermal element.

[0258] Clause 11. An automatic syringe comprising: a cartridge disposed within a housing for containing a drug; a fluid conduit configured to deliver the drug from the cartridge to a patient and movable from a retracted configuration to an deployed configuration; a position sensor; and a controller coupled to the position sensor, configured to prevent the automatic syringe from initiating an injection based on a position detected by the position sensor.

[0259] Clause 12. The automatic syringe according to claim 11, wherein the sensor includes at least one of a Global Positioning System (GPS) module, a WiFi module, a cellular modem, and a Bluetooth module.

[0260] Clause 13. Further comprising a plunger coupled to the housing and movable relative to the housing, and one or more electronic components used during injection performed by the automatic syringe, the one or more electronic components formed within an electrical circuit, wherein in a first configuration, a first portion of the plunger is located within the housing, the electrical circuit is open, and the one or more electronic components are in a low-power sleep mode; in a second configuration, the plunger moves outward relative to the housing, the first portion of the plunger extends outward from the housing, and in the second configuration, the electrical circuit is closed, and the one or more electronic components are in a low-power sleep mode; The automatic syringe according to claim 11, wherein the equipment component transitions from the low-power sleep mode to an active mode, the plunger is movable from the second configuration toward the housing to a third configuration, and unless otherwise instructed by the controller, the automatic syringe is configured to initiate injection by the automatic syringe only after the plunger has been moved toward the third configuration and one or more electronic equipment components are in the active mode, and the automatic syringe is configured to prevent initiating injection by the automatic syringe after the plunger has been moved toward the third configuration, based on the position detected by the position sensor.

[0261] Clause 14. The automatic syringe according to claim 11, further comprising a feedback module including at least one of a voice component configured to produce audible feedback, a visual component configured to produce visual feedback, and a haptic component configured to produce tactile feedback.

[0262] Clause 15. The automatic syringe according to claim 14, wherein the controller is configured to receive a first signal from an external device and, in response to the first signal, cause the feedback module to emit at least one of the audible feedback, the visual feedback, and the tactile feedback.

[0263] Clause 16. The automatic syringe according to claim 14, wherein the audible feedback is configured to be reduced by the user via an external device when it is emitted.

[0264] Clause 17. An automatic syringe comprising: a housing; a cartridge disposed within the housing for containing a drug; a fluid conduit configured to deliver the drug from the cartridge to a patient and movable from a stored configuration to an deployed configuration related to the administration of the drug; a fluid sensor configured to detect fluid within the housing; and a controller configured to prevent the automatic syringe from initiating an injection when the fluid sensor detects fluid within the housing.

[0265] Clause 18. The automatic syringe according to claim 17, wherein the fluid sensor includes an optical fluid sensor.

[0266] Clause 19. The automatic syringe according to claim 17, wherein the fluid sensor is adjacent to the partition wall of the cartridge.

[0267] Clause 20. Further comprising a plunger coupled to the housing and movable relative to the housing, and one or more electronic components used during injection performed by the automatic syringe, the one or more electronic components formed within an electrical circuit, wherein in a first configuration, a first portion of the plunger is located within the housing, the electrical circuit is open, and the one or more electronic components are in a low-power sleep mode; in a second configuration, the plunger moves outward relative to the housing, the first portion of the plunger extends outward from the housing, and in the second configuration, the electrical circuit is closed, and the one or more electronic components are in an electrical circuit. The automatic syringe according to claim 17, wherein the equipment component transitions from the low-power sleep mode to an active mode, the plunger is movable from the second configuration toward the housing to a third configuration, and unless otherwise instructed by the controller, the automatic syringe is configured to initiate injection by the automatic syringe only after the plunger has been moved toward the third configuration and one or more electronic components are in the active mode, and if the fluid sensor detects a leak in the housing, the automatic syringe is configured to prevent the initiation of injection by the automatic syringe after the plunger has been moved toward the third configuration.

Claims

1. It is an automatic syringe, Housing and A cartridge disposed within the housing, the cartridge containing the drug, A fluid conduit configured to deliver the drug from the cartridge to the patient and movable from a retracted configuration to an deployed configuration related to the administration of the drug, A temperature sensor configured to measure the temperature of the aforementioned drug, A controller coupled to the temperature sensor, The automatic syringe includes a controller configured to transmit a first signal to an external device when the temperature sensor detects that the temperature of the drug has risen above a first threshold temperature.

2. The automatic syringe according to claim 1, wherein the first threshold temperature is below the minimum safe temperature for the drug.

3. The automatic syringe according to claim 1, wherein the first signal causes the external device to display a warning.

4. The automatic injector according to claim 3, wherein the controller is configured to transmit a second signal when the temperature of the drug rises above the threshold temperature and then falls below the threshold temperature.

5. The automatic syringe according to claim 4, wherein the second signal is the cancellation of the warning on the external device.

6. The automatic syringe according to claim 1, wherein the controller is configured to prevent the automatic syringe from initiating injection when the temperature of the drug rises above a second threshold temperature that is higher than the first threshold temperature.

7. The automatic syringe according to claim 6, wherein the second threshold temperature is the minimum safe temperature of the drug.

8. A plunger coupled to the housing and movable relative to the housing, One or more electronic components used during injections performed by the automatic syringe, further comprising one or more electronic components formed within an electrical circuit, In the first configuration, the first portion of the plunger is located inside the housing, the electrical circuit is open, and one or more electronic components are in a low-power sleep mode. In the second configuration, the plunger moves outward relative to the housing, and the first portion of the plunger extends outward from the housing. In the second configuration described above, the electrical circuit is closed, and one or more electronic components transition from the low-power sleep mode to the active mode. The plunger is movable from the second configuration toward the housing toward the third configuration. Unless otherwise instructed by the controller, the automatic syringe is configured to initiate injection only after the plunger has moved to the third configuration and one or more electronic components are in the active mode. The automatic syringe according to claim 7, wherein if the drug temperature rises above the second threshold temperature, the automatic syringe is configured to prevent the initiation of injection by the automatic syringe after the plunger has been moved to the third configuration.

9. The automatic syringe according to claim 1, wherein the controller is configured to continuously transmit the temperature data of the drug to the external device.

10. The auto-injector according to claim 1, further comprising a thermal element connected to the controller and adjacent to the cartridge, wherein the controller is configured to selectively raise the temperature of the drug based on input provided by a user via a mobile device communicating with the auto-injector through the thermal element.

11. It is an automatic syringe, A cartridge placed inside a housing, the cartridge containing a drug, A fluid conduit configured to deliver the drug from the cartridge to the patient, and which is movable from a stored configuration to an deployed configuration, Position sensor and, The automatic syringe includes a controller coupled to the position sensor, the controller configured to prevent the automatic syringe from initiating an injection based on the position detected by the position sensor.

12. The automatic syringe according to claim 11, wherein the sensor includes at least one of a Global Positioning System (GPS) module, a Wi-Fi module, a cellular modem, and a Bluetooth module.

13. A plunger coupled to the housing and movable relative to the housing, One or more electronic components used during injections performed by the automatic syringe, further comprising one or more electronic components formed within an electrical circuit, In the first configuration, the first portion of the plunger is located inside the housing, the electrical circuit is open, and one or more electronic components are in a low-power sleep mode. In the second configuration, the plunger moves outward relative to the housing, and the first portion of the plunger extends outward from the housing. In the second configuration described above, the electrical circuit is closed, and one or more electronic components transition from the low-power sleep mode to the active mode. The plunger is movable from the second configuration toward the housing toward the third configuration. Unless otherwise instructed by the controller, the automatic syringe is configured to initiate injection only after the plunger has moved to the third configuration and one or more electronic components are in the active mode. The automatic syringe according to claim 11, wherein the automatic syringe is configured to prevent the initiation of injection by the automatic syringe after the plunger has been moved to the third configuration based on the position detected by the position sensor.

14. The automatic syringe according to claim 11, further comprising a feedback module including at least one of an audio component configured to produce audible feedback, a visual component configured to produce visual feedback, and a haptic component configured to produce tactile feedback.

15. The aforementioned controller, Receive a first signal from an external device, The automatic syringe according to claim 14, configured to cause the feedback module to emit at least one of the audible feedback, the visual feedback, and the tactile feedback in response to the first signal.

16. The automatic syringe according to claim 14, wherein the audible feedback, when emitted, is configured to be reduced by the user via an external device.

17. It is an automatic syringe, Housing and A cartridge disposed within the housing, the cartridge containing the drug, A fluid conduit configured to deliver the drug from the cartridge to the patient and movable from a retracted configuration to an deployed configuration related to the administration of the drug, A fluid sensor configured to detect the fluid inside the housing, An automatic syringe, comprising a controller configured to prevent the automatic syringe from initiating an injection when the fluid sensor detects fluid within the housing.

18. The automatic syringe according to claim 17, wherein the fluid sensor includes an optical fluid sensor.

19. The automatic syringe according to claim 17, wherein the fluid sensor is adjacent to the partition wall of the cartridge.

20. A plunger coupled to the housing and movable relative to the housing, One or more electronic components used during injections performed by the automatic syringe, further comprising one or more electronic components formed within an electrical circuit, In the first configuration, the first portion of the plunger is located inside the housing, the electrical circuit is open, and one or more electronic components are in a low-power sleep mode. In the second configuration, the plunger moves outward relative to the housing, and the first portion of the plunger extends outward from the housing. In the second configuration described above, the electrical circuit is closed, and one or more electronic components transition from the low-power sleep mode to the active mode. The plunger is movable from the second configuration toward the housing toward the third configuration. Unless otherwise instructed by the controller, the automatic syringe is configured to initiate injection only after the plunger has moved to the third configuration and one or more electronic components are in the active mode. The automatic syringe according to claim 17, wherein if the fluid sensor detects a leak in the housing, the automatic syringe is configured to prevent the initiation of injection by the automatic syringe after the plunger has been moved to the third configuration.

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