Reusable Digital Module for an Auto-Injector

Abstract

Provided herein is a digital module for an auto-injector, which includes a housing having a distal end and a proximal end and configured to releasably mate with an auto-injector, and a first circuit board received within the housing, the circuit board having a proximal end and a distal end and including at least one switch, at least one processor in communication with the at least one switch, at least one communication interface, and at least one power source.

Description

Technical Field

[0001] The present disclosure generally relates to drug delivery devices, and more specifically to autoinjectors.

Background Art

[0002] This application claims the priority of European Application No. 22177576.0, entitled "Reusable Digital Module for Autoinjector", filed on June 7, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Various types of autoinjectors have been developed to enable untrained personnel to administer or self-inject pharmaceutical solutions and other liquid therapeutic agents. Generally, these devices include a reservoir pre-filled with a liquid therapeutic agent and some type of automatic needle injection mechanism that can be triggered by the user. Many of these devices, such as autoinjectors, are designed such that a reservoir, such as a pre-filled syringe, is assembled into the device during device assembly. In addition to automatically deploying the needle injection mechanism, many drug delivery devices automatically shield the needle after use of the device to prevent any unintended contact with the needle.

[0004] Such drug delivery devices have conventionally lacked features that enable a healthcare provider to automatically record or capture data indicating proper administration of the drug. Ensuring timely and proper administration of some pharmaceuticals can be important, particularly in examples such as the evaluation of new drugs in clinical trials where accurate information is essential. It may also be advantageous to include such functionality without changing the appearance of the drug delivery device, without adding additional steps for the user, and without adding additional complexity inside the device.

[0005] Some devices provide the ability to communicate specific information, as described, for example, in Patent Document 1, Patent Document 2, Patent Document 3, Patent Document 4, and Patent Document 10, as well as Patent Document 11, Patent Document 12, and Patent Document 13. However, in this technical field, there is a need for a cost-effective and reusable device that can accurately detect drug delivery and timely transmit this drug delivery information to appropriate stakeholders.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

Patent Document 11

Patent Document 12

Patent Document 13

Patent Document 14

[0007] Provided herein is a digital module for an autoinjector, including a housing having a distal end and a proximal end and configured to releasably mate with an autoinjector, and a first circuit board received within the housing, the circuit board having a proximal end and a distal end and including at least one switch, at least one processor in communication with the at least one switch, at least one communication interface, and at least one power source.

[0008] In certain configurations, the at least one switch is at least one mechanical switch and / or at least one optical sensor. Optionally, the at least one switch is at least one mechanical switch and at least one optical sensor. In other configurations, the at least one mechanical switch is located distal to the at least one optical sensor. The at least one optical sensor may be located distal to the at least one mechanical switch. The at least one circuit board may be a printed circuit board.

[0009] In certain configurations, the housing may define a channel configured to receive a plunger body of the autoinjector. The digital module may also include a second circuit board including at least one switch, at least one processor in communication with the at least one switch, at least one communication interface, and at least one power source. The first circuit board and the second circuit board may be received within the housing on opposite sides of the channel.

[0010] Also provided herein is an autoinjector including a housing having a proximal end and a distal end, a syringe including a barrel, a stopper, and a needle disposed at the distal end of the syringe, at least a portion of the syringe being disposed within the housing, a drive assembly including a drive member and a plunger body, the drive assembly being configured to move the stopper within the barrel upon actuation of the drive assembly, at least a portion of the drive assembly being disposed within the housing, a needle cover having a pre-use position in which the needle is positioned within the needle cover, an actuation position in which the needle cover is shifted proximally thereby enabling actuation of the drive assembly, and a post-use position in which the needle is positioned within the needle cover, and a digital module including a housing having a distal end and a proximal end and configured to releasably mate with an autoinjector, a first circuit board received within the housing, the circuit board having a proximal end and a distal end, and including at least one switch, at least one processor in communication with the at least one switch, at least one communication interface, and at least one power source, wherein the at least one switch is actuated by the plunger body when the plunger body moves distally during actuation of the drive assembly, and actuation of the at least one switch indicates the start and / or end of dose delivery.

[0011] In certain configurations, the at least one switch includes at least one proximal sensor and at least one distal sensor, actuation of the proximal sensor indicating the start of dose delivery and actuation of the distal sensor indicating the end of dose delivery. The plunger body may include a rack having a plurality of teeth, and the at least one switch detects movement of the plunger body based on the passage of one or more teeth. Optionally, the plunger body further includes at least a first flange configured to actuate the at least one switch, and actuation of the at least one switch by the flange indicates the start of dose delivery.

[0012] The plunger body may include at least a second flange configured to activate at least one switch, and activation of the at least one switch by the flange indicates the end of dose delivery. The autoinjector may also include a second circuit board including at least one switch, at least one processor in communication with the at least one switch, at least one communication interface, and at least one power source. The first circuit board and the second circuit board may be received within the housing on opposite sides of the channel.

Brief Description of the Drawings

[0013]

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Best Mode for Carrying Out the Invention

[0014] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the present invention.

[0015] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," and their derivatives shall relate to the present invention as oriented in the drawings. However, it should be understood that the present invention may assume various alternative variations unless explicitly specified to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0016] It should be understood that any numerical range recited herein is intended to include all values and subranges subsumed therein. For example, a range of "1 to 10" is intended to include all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, i.e., ranges having a minimum value of 1 or more and a maximum value of 10 or less.

[0017] As used herein, the terms "communication" and "communicate" refer to the reception or transmission of one or more signals, messages, commands, or other types of data. For one unit (e.g., any device, system, or component thereof) to communicate with another unit means that one unit can receive data from and / or transmit data to the other unit, either directly or indirectly. This can imply a direct or indirect connection that is essentially wired and / or wireless. Further, two units can communicate with each other even if the data being transmitted is modified, processed, relayed, and / or routed between the first unit and the second unit. For example, even if a first unit passively receives data and does not actively transmit data to a second unit, the first unit can communicate with the second unit. As another example, if an intermediate unit processes data from one unit and transmits the processed data to a second unit, the first unit can communicate with the second unit. It will be understood that many other arrangements are possible. Any known electronic communication protocol and / or algorithm can be used, such as TCP / IP (including HTTP and other protocols), WLAN (including 902.11a / b / g / n and other radio frequency-based protocols and methods), analog transmission, Global System for Mobile Communications (GSM), 3G / 4G / LTE, BLUETOOTH®, NFC, RFID, ZigBee, EnOcean, TransferJet, Wireless USB, NarrowBand IoT (NBIoT), Low Power, Wide Area Network Protocol (LoraWan), Ultra-WideBand (UWB), etc., as known to those skilled in the art. In some non-limiting embodiments or aspects, a message can refer to a network packet (e.g., a data packet and / or the like) that contains data.

[0018] As used herein, the term "computing device" can refer to one or more electronic devices configured to process data. A computing device may, in some instances, include components necessary to receive, process, and output data such as a processor, a display, memory, an input device, a network interface, and / or the like. A computing device may be a mobile device. By way of example, a mobile device may include a cellular phone (e.g., a smartphone or a standard cellular phone), a portable computer, a wearable device (e.g., a watch, glasses, lenses, clothing, etc.), a personal digital assistant (PDA), and / or other similar devices. A computing device may also be a desktop computer, or other forms of non-mobile computers including a server, and may be a distributed computing paradigm such as edge computing.

[0019] Provided herein are digital modules for drug delivery devices, drug delivery devices including such modules, and systems and methods including the use of such devices to monitor the delivery of a drug using a drug delivery device. The devices, systems, and methods described herein enable timely and accurate monitoring of drug delivery by interested parties in a cost-effective manner, for example, by using more robust data management solutions to improve the clinical trials of newly developed drugs, thereby improving conventional devices and methods for determining drug administration.

[0020] Patent Document 5, Patent Document 6, Patent Document 7, Patent Document 8, and Patent Document 9 are hereby incorporated by reference in their entirety.

[0021] Shown in FIGS. 1 and 2 is a drug delivery device 100. The drug delivery device 100 can include a first sub-assembly 110, a second sub-assembly 140, and a syringe 116. The first sub-assembly 110 can include a lower housing shell 112, a cap 114, a syringe holder 118, a needle cover 124, and a cassette body 128. The second sub-assembly 140 can include a drive assembly including a plunger body 150, and the plunger body 150 includes a plunger rod 152 and a spring guide member 154 including a drive member 156 and a drive opening 158. The second sub-assembly 140 can further include a motor body 159, a lever actuating member 130, and an upper housing shell 142. The syringe 116 can be received by the syringe holder 118 and can include a barrel 117, a stopper 122, a needle 120, and a rigid needle shield (RNS) 126. Although the RNS is utilized, other suitable needle shield configurations can be utilized. The lower housing shell 112, the cassette body 128, and the upper housing shell 142 generally form a housing for receiving various components of the drug delivery device 100, although other suitable housing arrangements can be utilized. The first sub-assembly 110 and the second sub-assembly 140 are fixed to each other by a lock clip during assembly, although other suitable arrangements can be utilized. The drug delivery device 100 can be an auto-injector, although the features described herein may be incorporated into other suitable drug delivery devices.

[0022] The drug delivery device 100 is configured to automatically deliver a drug from the syringe 116 to a patient during operation of the device 100. More specifically, during operation of the drug delivery device 100, the drive assembly engages the stopper 122 of the syringe 116, moves the syringe 116 such that the needle 120 pierces the patient's skin, and moves the stopper 122 within the barrel 117 of the syringe 116 to deliver the drug within the barrel 117. The drug delivery device 100 includes a storage position, a pre-use position, an operating position, an injection position, and a post-use position as described in Patent Documents 5, 6, 7, 8, and 9. The needle cover 124 is configured to shield the needle 120 of the syringe 116 from the patient when the device 100 is in the pre-use position and the post-use position. In particular, the needle cover 124 is movable between the pre-use position, the operating position, and the post-use position, and a spring 125 biases the needle cover 124 towards the pre-use position and the post-use position. The spring 125 may be positioned between the needle cover 124 and the syringe holder 118, although other suitable arrangements may be utilized. The lever actuating member 130 is movable between a locked position where movement of the drive assembly 40 is blocked and an unlocked position where movement of the drive assembly is permitted. More specifically, the lever actuating member 130 is rotatable about a rotation axis between the locked position and the unlocked position. When the lever actuating member 130 is in the locked position, the lever actuating member 130 engages the motor body 159 and the drive assembly to prevent movement of the drive assembly. When the lever actuating member 130 is in the unlocked position, this can be achieved by pressing the needle cover 124 against the patient's skin at the injection site and shifting the needle cover proximally into the lower housing shell 112, although the lever actuating member 130 is disengaged from the motor body 159, thereby enabling movement of the drive assembly towards the syringe 116. The rotation axis of the lever actuating member 130 extends perpendicular to the longitudinal axis of the device 100, although other suitable arrangements may be utilized.

[0023] Referring again to FIGS. 1 and 2, the drive assembly includes a plunger body 150 having a plunger rod portion 152 and a drive member 156. The drive member 156 is a compression spring received within a drive opening 158 defined by the plunger body 150, although other suitable drive members may be utilized including, but not limited to, compressed gas, electric motors, hydraulics, other types of springs, etc. The drive member 156 engages the plunger body 150 and the motor body 159 and biases the plunger body 150 in a direction extending from the second sub-assembly 14 towards the first sub-assembly 110. The plunger body 150 receives a lever actuating member 130 and defines a lever opening that defines a rotational axis of the lever actuating member 130. The lever actuating member 130 prevents movement of the plunger body 150 when the lever actuating member 130 is in a locked position due to the engagement of the lever actuating member 130 and the motor body 159. When the lever actuating member 130 rotates from the locked position to the released position, the lever actuating member 130 disengages from the motor body 159, whereby the drive member 156 can move the plunger body 150 and the plunger rod 152 towards the first sub-assembly 110. The plunger rod 152 and the drive member 156 are spaced apart from each other and parallel and extend in the longitudinal direction of the device 100.

[0024] The drive assembly 40 is fixed to the upper housing shell 142 and further includes a spring guide member 154 received within the drive opening 158 of the plunger body 15. The drive member 156 is received by the spring guide member 154 such that it is positioned between the plunger body 150 and the spring guide member 154. Also, the drive assembly may include a plunger rod cover 92 that receives the plunger rod 152 of the plunger body 150. The plunger rod cover guides the insertion of the plunger rod 152 into the barrel 115 of the syringe 116 and engages a stopper 122 and is configured to discharge a drug from the barrel 117 of the syringe 116. The plunger rod cover and the plunger rod 152 may be integrally formed or formed as separate members.

[0025] The plunger body 150 of the drive assembly may also include an audible indicator member 160 configured to provide an audible indication to the user when the device 100 transitions to the post-use position. The audible indicator member 160 may be configured to engage one or more ribs of the cassette body 128 when the device 100 is in the injection position, thereby deflecting the audible indicator member 160. When the drug delivery device 100 transitions from the injection position to the post-use position, the audible indicator member 160 disengages from the ribs of the cassette body 128 and contacts the lower housing shell 112 to provide an audible click sensation, although the audible indicator member 160 may also contact other suitable portions of the device 100 to provide an audible indication.

[0026] Continuing to refer to FIG. 1, the drug delivery device 100 may further include a digital module 180. The digital module 180 may be reversibly attachable to the drug delivery device 100 housing, such as the upper housing shell 142. Referring to FIGS. 3 and 8, the digital module may include a housing 182, and the digital module 180 may be reversibly attachable to the drug delivery device 100 via, for example, a hinge connection, a slide connection, a snap connection, a friction fit, and / or other interactions known to those skilled in the art between the upper housing shell 142 and the housing 182.

[0027] The digital module 180 may further include one or more circuit boards, one or more power supplies, one or more processors, one or more communication interfaces, and one or more switches. FIGS. 3 through 13D illustrate various non-limiting embodiments of the arrangement of the components of the digital module 180. In non-limiting embodiments, the circuit board can be a printed circuit board, a flexible substrate for printed electronics, etc., as known in the art. In non-limiting embodiments, a plurality of circuit boards are included, and the circuit boards are optionally connected to each other for electronic communication. In non-limiting embodiments, the switch can independently be an optical sensor, an ultrasonic sensor, a capacitive sensor, a force resistance sensor, an electrical switch, an electromagnetic switch, and / or a mechanical switch, and can communicate with one or more processors on the circuit board. In non-limiting embodiments, the digital module 180 is reusable and can use a suitable rechargeable or replaceable power supply.

[0028] Referring to FIGS. 3 through 7B, a non-limiting embodiment of the digital module 180 is shown that includes a housing 182, a circuit board 184, a power supply 186, a mechanical switch 188, and an optical sensor (e.g., an optical switch) 190. Suitable mechanical switches are known to those skilled in the art and can include the ESE13V05 from Panasonic (Kadoma, Osaka, Japan) and the HDT0001 switch manufactured by C&K (Waltham, Massachusetts). Suitable optical sensors are known to those skilled in the art and can include reflective encoders such as the AEDR-9820 from Broadcom (San Jose, California), slot-type optical gate sensors such as the TCUT1300X01 from Vishay (Malvern, Pennsylvania), and reflective optical sensors such as the OPB9000 from TT Electronics (Woking, UK). In a non-limiting embodiment, a reflective code strip can be applied to the plunger body 150 such that it can be sensed by the optical switch 190 as the plunger body 150 moves distally during dose delivery. Suitable reflective code strips are known to those skilled in the art and can include those from Photo Solutions (Wilsonville, Oregon), Meltec (Nagareyama, Chiba, Japan), GM Nameplate (Seattle, Washington), and pwb (Eisenach, Germany). In a non-limiting embodiment (described below), the rack can be applied to the plunger body 150 or co-molded as part of the plunger body 150 and can include one or more teeth and / or flanges for actuating the switches 188 and / or 190.

[0029] In the illustrated embodiments of FIGS. 3 through 7B, each circuit board 184 includes two switches and an optical sensor 190 positioned distal to a mechanical switch 188. As noted above, any suitable number, combination, and arrangement of switches may be used. In non-limiting embodiments, at least one switch is positioned such that it is actuated before the stopper 122 reaches its most distal position (e.g., end of dose delivery) to include all values and sub-ranges between about 2.2 mm, about 2 mm, about 1.5 mm, about 1.1 mm, or about 1 mm. In the non-limiting embodiments of FIGS. 3 through 7B, the circuit board 184 is disposed in the housing 182 to provide a channel between two circuit boards, and one or more of the switches 188, 190 are disposed facing the channel. As shown in FIGS. 4 through 7B, this allows components of the drive assembly of the drug delivery device 100 to be received within the channel and interact with the switches.

[0030] Figures 4 through 6 show plunger body 150 and digital module 180 (housing 182 not shown). In an embodiment, plunger body 150 includes rack 162. In a non-limiting embodiment, rack 162 can include one or more teeth 164. Teeth 164 can be arranged on rack 162 in any suitable configuration. In a non-limiting embodiment, teeth 164 are arranged at intervals of about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1.0 mm, including all values and sub-ranges therebetween. One of ordinary skill in the art will understand that the number of optical switches 190, and the spacing between teeth 164, can be modified to increase the resolution or robustness of the switches and the information they transmit. Rack 162 can be arranged on plunger body 150 such that one or more teeth 164 interact with one or more optical sensors 190. In a non-limiting embodiment, rack 162 and / or plunger body 150 can also include one or more flanges 166. Plunger body 150 and / or rack 162 can be arranged such that one or more flanges 166 interact with one or more mechanical switches 188.

[0031] Referring now to FIGS. 7A-7B, images of the drug delivery device 100 in its pre-use (FIG. 7A) and post-use (FIG. 7B) positions are shown with respect to the digital module 180. As shown in FIG. 7A, prior to actuation of the drive assembly, the rack 162 is in its proximal position and the mechanical switches 188a, 188b are not actuated. After the drive assembly is actuated, the plunger body 150, along with the rack 162, begins to move distally. One or more flanges 166a, 166b, 166c contact one or more mechanical switches 188a, 188b, activating the digital module 180 and initiating data recording (described in more detail below). In non-limiting embodiments, the digital module 180 may include one or more gyroscopes or other position sensors such that the digital module 180 is activated when the device is picked up by a user. As described in more detail below (see FIGS. 12-15), the switches may be arranged and the processor included on the circuit board 184 may be programmed to determine only the start and end of drug delivery and / or may be arranged and programmed to continuously record data throughout drug delivery. In non-limiting embodiments, the digital module 180 may include one or both configurations. For example, in non-limiting embodiments, the digital module 180 may include both configurations as shown in FIGS. 7A-7B. In the illustrated embodiment of FIGS. 7A-7B, one or more teeth 164 of the rack 162 interact with one or more optical sensors 190a, 190b at the reflective optical sensor 190 in the illustrated embodiment, and thus data may be continuously recorded during the drug delivery procedure. In the non-limiting embodiment of FIGS. 7A-7B, the optical sensor 190b senses the passage of the flange 166c, indicating the end of drug delivery.

[0032] Referring to FIGS. 8 through 11B, another non-limiting embodiment of the digital module 180 including a housing 182 (shown only in FIG. 8), a circuit board 184, a power source 186, a mechanical switch 188, and an optical sensor 190 is shown. In the non-limiting embodiment of FIGS. 8 through 11B, the circuit board 184 is disposed in the housing 182 so as to provide a channel between the two circuit boards 184, and one or more of the switches 188, 190 are disposed facing the channel. As shown in FIGS. 8 through 11B, this allows components of the drive assembly of the drug delivery device 100 to be received within the channel and interact with the switches.

[0033] FIGS. 9 through 10 show a plunger body 150 and a digital module 180 (housing 182 not shown). In an embodiment, the plunger body 150 includes a rack 162. In a non-limiting embodiment, the rack 162 may include one or more teeth 164. The rack 162 may be disposed on the plunger body 150 such that one or more of the teeth 164 are capable of interacting with one or more optical sensors 190. In a non-limiting embodiment, the rack 162 and / or the plunger body 150 may also include one or more flanges 166. The plunger body 150 and / or the rack 162 may be disposed such that one or more of the flanges 166 are capable of interacting with one or more mechanical switches 188. In the non-limiting embodiment of FIGS. 8 through 11B, the optical sensor is a slotted optical sensor disposed such that one or more teeth 164 of the rack 162 pass between two opposing sensors 190.

[0034] Referring now to FIGS. 11A through 11B, images of the drug delivery device 100 in the pre-use (FIG. 11A) and post-use (FIG. 11B) positions are shown with respect to the digital module 180. As shown in FIG. 11A, prior to actuation of the drive assembly, the rack 162 is in the proximal position and the mechanical switches 188a, 188b are not actuated. After the drive assembly is actuated, the plunger body 150, together with the rack 162, begins to move distally. One or more flanges 166a, 166b, 166c contact one or more mechanical switches 188a, 188b, activating the digital module and initiating data recording (described in more detail below). As described in more detail below (see FIGS. 12 through 15), the switches may be arranged and the processor included on the circuit board 184 may be programmed to determine only the start and end of drug delivery and / or may be arranged and programmed to continuously record data throughout drug delivery. In non-limiting embodiments, both configurations may be included in the same digital module, for example, as shown in FIGS. 7A through 7B. In the illustrated embodiment of FIGS. 11A through 11B, one or more teeth 164 of the rack 162 interact with one or more optical sensors 190a, 190b, which are slotted optical sensors in the illustrated embodiment, and thus data may be continuously recorded during the drug delivery procedure. In the non-limiting embodiment of FIGS. 11A through 11B, the mechanical switch 188c disengages from the end of the rack 162 after the proximal end of the rack 162 has passed, indicating the end of drug delivery.

[0035] Referring to FIGS. 12 through 13D, non-limiting embodiments of the arrangement of switches 188, 190, and the interaction between the arranged switches 188, 190 and the teeth 164 and / or flange 166 of the plunger body are shown. As described above, the arrangement of switches 188, 190 can be modified to provide an indication of only the start and end of dosing, the start and end of dosing and continuous monitoring of the dose as it is delivered, or any combination thereof. In the non-limiting embodiment of FIG. 12, when drug delivery is initiated, mechanical switch 188 is actuated by flange 166. This can activate a processor provided on one or more circuit boards. Thereafter, optical sensor 190 detects the passage of teeth 164 as the rack 162 having plunger body 150 moves distally to expel the drug from syringe 116. Thus, the embodiment of FIG. 12 can provide an indication of the start of dose delivery, as well as continuous monitoring of the dose, when each tooth 164 passes through and is sensed by optical switch 190.

[0036] Turning now to FIGS. 13A through 13D, further non-limiting embodiments of the arrangement of switches 188, 190, and the interaction between the arranged switches 188, 190 and the teeth 164 and / or flange 166 of the plunger body are shown. FIG. 13A shows a non-limiting embodiment in which only one optical switch 190 is used to provide continuous monitoring throughout dose delivery. FIG. 13B shows the use of two optical switches 190 arranged such that the phase of the switches is shifted by 90 degrees to provide continuous monitoring throughout dose delivery. This configuration may provide increased resolution and may also be suitable for determining the direction of movement of the plunger body 150. FIG. 13C shows the use of two optical switches 190 with minimal overlap to provide continuous monitoring throughout dose delivery. The nearest switch 190 (S.O.D.) monitors the first half of dose delivery, and the farthest switch 190 (E.O.D.) monitors the second half of dose delivery. FIG. 13D shows the use of two overlapping optical switches to provide continuous monitoring throughout dose delivery. The nearest switch 190 (S.O.D.) monitors dose delivery and near the end of dose delivery, and the farthest switch 190 (E.O.D.) provides improved resolution as the plunger body 150 slows down (due to a drive member providing less force).

[0037] Referring to FIG. 14, a non-limiting embodiment is shown in which a circuit board 184 includes a camera 192 instead of (or in addition to) switches 188, 190. The camera 192, which may be a Time of Flight (ToF) camera, may interact with a reflective element 194, such as a mirror, disposed on the plunger body 150 to detect movement of the plunger body 150 during dose delivery. Although the camera 192 is illustrated, those skilled in the art will understand that other optical distance measurement systems, such as Light Detection and Ranging (LIDAR), may be used to determine the distance between a fixed point and the plunger body 150 during dose delivery, and that time data may be generated and transmitted therefrom as described below.

[0038] Referring now to FIG. 15, there is shown a diagram of an example of an environment in which the systems, devices and / or methods described herein may be implemented. As shown in FIG. 15, the environment can include a drug delivery device 800, a user device 802, a healthcare system 804, and / or a communication network 806. The drug delivery device 800, the user device 802, and the healthcare system 804 can be interconnected (e.g., establish a connection for communication) via a wired connection, a wireless connection, or a combination of wired and wireless connections.

[0039] The drug delivery device 800, which can be an autoinjector as described herein, can include a digital module 810 that includes a first switch 820, any additional switches 830n, a processor 840, and a communication interface 850, as described above. The drug delivery device 800 can be configured to communicate with a user device 802, such as a computing device as described herein.

[0040] The communication network 806 can include one or more wired and / or wireless networks. For example, the communication network 806 can include a BLUETOOTH (registered trademark) connection (e.g., between the drug delivery device 800 and the user device 802), a cellular network (e.g., a Long-Term Evolution (LTE) network, a third-generation (3G) network, a fourth-generation (4G) network, a fifth-generation (5G) network, a Code Division Multiple Access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a low-power wide area network (LPWAN), an ultra-wideband network (UWB), a metropolitan area network (MAN), a telephone network (e.g., a public switched telephone network (PSTN) and / or the like), a private network, an ad hoc network, an intranet, the Internet, an optical fiber-based network, a cloud computing network, and / or the like, and / or a combination of these or other types of networks.

[0041] In some non-limiting embodiments, the user device 802 can be a computing device, a smartphone, a smartwatch, a tablet, a laptop computer, a desktop computer, or other computing device as described herein. The user device 802 can be programmed or configured to communicate with the healthcare system 804, for example, via the communication network 806 and via an application such as a mobile application executable on the user device 802.

[0042] The healthcare system 804 can include a server, a group of servers, and / or other similar devices. A plurality of healthcare systems 804 can provide, for example, systems associated with device manufacturers, systems associated with pharmaceutical manufacturers, systems associated with healthcare providers, systems associated with clinical research, systems associated with government agencies, and / or systems associated with research sponsors, such as sponsors of clinical trials.

[0043] Referring now to FIG. 16, there is shown a diagram of exemplary components of an exemplary computing device 900 that can be used with the systems, devices, and methods described herein. Such a computing device 900 can correspond to components within a drug delivery device as described herein, a user device as described herein, and / or a connection module of a healthcare system as described herein. As shown in FIG. 9, the device 900 can include a bus 902, a processor 904, a memory 906, a storage component 908, an input component 910, an output component 912, and a communication interface 914.

[0044] Bus 902 may include components that enable communication between components of computing device 900. In some non-limiting embodiments, processor 904 may be implemented in hardware, software, or a combination of hardware and software. For example, processor 904 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), and / or the like) that can be programmed to execute functions, a microprocessor, a digital signal processor (DSP), and / or any processing component (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), and / or the like). Memory 906 may include a random access memory (RAM), a read only memory (ROM), and / or another type of dynamic or static storage memory (e.g., flash memory, magnetic memory, optical memory, and / or the like) that stores information and / or instructions for use by processor 904.

[0045] Storage component 908 may store information and / or software related to the operation and use of computing device 900. For example, storage component 908 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, a solid state disk, and / or the like), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium, along with a corresponding drive.

[0046] The input component 910 may include a component that enables the computing device 900 to receive information via user input (e.g., touch screen display, keyboard, keypad, mouse, button, switch, microphone, camera, and / or the like). Additionally or alternatively, the input component 910 may include sensors for sensing information (e.g., global positioning system (GPS) component, accelerometer, gyroscope, actuator, microphone, environmental sensors (e.g., temperature, humidity, etc.) and / or the like). The output component 912 may include a component that provides output information from the computing device (e.g., display, speaker, one or more light emitting diodes (LEDs), tactile indicator, etc.).

[0047] The communication interface 914 may include components such as a transceiver (e.g., a transceiver, a separate receiver and transmitter, etc.) that enable the device to communicate with other devices via, for example, a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication interface 914 may enable the computing device 900 to transmit and / or receive information from another device. For example, the communication interface 914 may include an Ethernet® interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, a cellular network interface, a BLUETOOTH® interface, and / or the like. In a non-limiting embodiment, the communication interface 914 does not operate via short-range wireless communication. Appropriate communication protocols and methods for ensuring communication between the communication interface 914 and the communication interface of another device, such as a computing device (e.g., a desktop computer, a laptop computer, a smartphone, a smartwatch, a PDA, a tablet, etc.), may include encryption using, for example, the secure socket layer (SSL) (e.g., using a public / private key pair as is known in the art). Additional security protocols are disclosed, for example, in Patent Document 14 and Patent Document 15, the contents of which are hereby incorporated by reference in their entirety. In the non-limiting embodiments described herein, the communication interface 914 is provided on the plunger rod. In a non-limiting embodiment, the communication interface 914 is configured to transmit data but not to receive data transmitted by a computing device, such as a user's smartphone.

[0048] A computing device may execute one or more processes described herein. The computing device may execute these processes based on the processor 904 executing software instructions stored by a computer-readable medium such as the memory 906 and / or the storage component 908, and / or being instructed by a separate computing device. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. The non-transitory memory device may include a memory space disposed within a single physical storage device or a memory space spanning multiple physical storage devices.

[0049] The software instructions may be read into the memory 906 and / or the storage component 908 from another computer-readable medium or from another device via the communication interface 914. When executed, the software instructions stored in the memory 906 and / or the storage component 908 may cause the processor 904 to execute one or more processes described herein. Additionally, or alternatively, hardwired circuitry may be used instead of or in combination with software instructions to execute one or more processes described herein. Accordingly, the embodiments described herein are not limited to any particular combination of hardware circuitry and software.

[0050] Referring to FIG. 15, in a non-limiting embodiment, the drug delivery device 800 includes a digital module 810 as described above, which includes a first switch 820 and additional switches 830n that communicate with a processor 840. The processor 840 communicates with a communication interface 850. Thus, the digital module 810 can communicate via the communication interface 850 with a user's computing device 802, such as a smartphone, which has its own associated communication interface and processor, as well as memory, storage components, buses, input components, and / or output components. In a non-limiting embodiment, the communication interface 850 can also communicate with a healthcare system 804.

[0051] In a non-limiting embodiment, the digital module 810 communicates unidirectionally with the user's computing device 802 and / or the healthcare system 804. For example, the digital module 810 can only transmit data to the user device 802 and / or the healthcare system 804 and cannot receive data from the user device 802 and / or the healthcare system 804. In a non-limiting embodiment, the processor associated with the user device 802 can be programmed or configured to put the communication interface associated with the user device 802 into sleep mode until the communication interface transmits data from the digital module 810, based on, for example, a mobile application stored in the memory and / or storage components of the user device 802.

[0052] In a non-limiting embodiment, the mechanical switch 188 can be used to determine the assembly time of the drug delivery device 100. For example, the switch 188 is actuated during the assembly process, and the time data from the assembly can be recorded and processed as described below.

[0053] In a non-limiting embodiment, when the drug delivery device 800 is activated, the first switch 820 is activated. When the first switch 820 is in communication with the processor 840, the processor 840 receives a first signal from the first switch 820 and optionally generates first time data and optionally transmits the first time data to the user device 802 and / or the healthcare system 804 using the communication interface 850, optionally using one or more identifiers (e.g., a device identifier and / or an identifier associated with the communication interface 850). In a non-limiting embodiment, additional data such as data related to the power level of the power source, a counter value, and / or other data related to the drug contained (e.g., expiration date, lot number, manufacturer, etc.) and / or the function of the drug delivery device 800 (e.g., a location determined by GPS, device orientation, etc.) is also transmitted. In a non-limiting embodiment, the first time data and / or one or more identifiers are encrypted before being transmitted to the user device 802. In a non-limiting embodiment, the processor accepts data transmitted by the communication interface 850 of the drug delivery device 800 only if certain conditions are met. In a non-limiting embodiment, one or more conditions can include that any message received from the drug delivery device 800 contains one or more of an identifier associated with the communication interface 850, an identifier associated with the drug delivery device 800, and / or a first identifier associated with the activation of the first switch 820 (e.g., associated with the first signal). In a non-limiting embodiment, following the check, if the message is the first transmitted message containing the first identifier and indicates that the message has not been previously transmitted by the drug delivery device 800, the message received from the drug delivery device when the first switch 820 is activated is accepted by the user device 802 and / or the healthcare system 804.In a non-limiting embodiment, after the check, if the first identifier and combination of identifiers associated with the drug delivery device 800 and / or communication interface 850 have not been previously transmitted to the user device 802 and / or healthcare system 804, the message is accepted by the user device 802 and / or healthcare system 804.

[0054] In a non-limiting embodiment, the user device 802 can generate a first timestamp from the first time data using a processor (e.g., processor 904), and transmit the first timestamp to the healthcare system 804 (optionally, using one or more identifiers associated with the drug delivery device 800 as described herein). In a non-limiting embodiment, when the first timestamp is transmitted to the healthcare system 804, the user device 802 terminates any connection with the digital module 810. In a non-limiting embodiment, for example, an embodiment where continuous monitoring is provided, the drug delivery device 800 continuously collects data during the drug delivery process and optionally transmits it continuously. In such an embodiment, the above may be repeated, for example, second, third, etc. timestamps may be generated based on second, third, etc. time data, and such data and / or timestamps may optionally be transmitted to the user device 802 and / or healthcare system 804 together with any other data described herein.

[0055] In a non-limiting embodiment, at the end of the drug delivery process, the first switch 820, or an additional switch (optical or mechanical) 830n, is actuated. When the first switch 820 or the additional switch 830n is in communication with the processor 840, the processor 840 receives a signal from the first switch 820 or the additional switch 830n, as described above, and final time data is generated. The processor then uses the communication interface 850 to transmit the final time data, optionally with one or more identifiers (e.g., a device identifier and / or an identifier associated with the communication interface 850), to the user device 802. In a non-limiting embodiment, the final time data and / or one or more identifiers are encrypted before being transmitted to the user device 802 and / or the healthcare system 804. As described above, in a non-limiting embodiment, the user device 802 and / or the healthcare system 804 accept data transmitted by the drug delivery device 800 only if certain conditions are met. In a non-limiting embodiment, one or more conditions can include that any message received from the drug delivery device 800 includes one or more of an identifier associated with the communication interface 850, an identifier associated with the drug delivery device 800, and / or a second identifier associated with the actuation of the additional switch 830n. In a non-limiting embodiment, a message received from the drug delivery device upon actuation of the additional switch 830n is accepted by the user device 802 and / or the healthcare system 804 (and, in a non-limiting embodiment, communication between the drug delivery device 800 and the user device 802 and / or the healthcare system 804 is re-established) because such a message is a first transmitted message that includes the second identifier and indicates that the message has not been previously transmitted by the drug delivery device 800.In non-limiting embodiments, the user device 802 and / or the healthcare system 804 can generate a final timestamp from the final time data using a processor (e.g., processor 904), and in the case of the user device 802, the final timestamp can be transmitted to the healthcare system 804 (optionally, using one or more identifiers associated with the drug delivery device 800 as described herein). In non-limiting embodiments, when the final timestamp is transmitted to the healthcare system 804, the user device 802 terminates any connection with the digital module 810.

[0056] In non-limiting embodiments, the user device 802 transmits the final timestamp and / or duration data to the healthcare system 804 (optionally, using one or more identifiers associated with the drug delivery device 810 as described herein). In non-limiting embodiments, the healthcare system can verify the timestamp data and / or duration data by comparing, for example, the timestamp data, duration data, plunger rod travel data (e.g., speed and / or acceleration), and / or combinations thereof to respective predetermined ranges / values. In non-limiting embodiments, data outside of a predetermined range can be marked for follow-up or a message can be sent to the user device 802 to alert of the problem.

[0057] In non-limiting embodiments, the healthcare system 804 may communicate with one or more additional healthcare systems 804. For example, one healthcare system may be maintained by a device manufacturer and may communicate with a healthcare system maintained by a test requester, a pharmaceutical manufacturer, etc. In non-limiting embodiments, a timestamp (a first timestamp, a second timestamp, and / or a final timestamp) and / or duration data, along with one or more identifiers (e.g., a device identifier and / or an identifier associated with the communication interface 850), may be sent from the device manufacturer system to a research sponsor system or a pharmaceutical manufacturer system, and one or more databases may store data associating one or more identifiers (e.g., a device identifier and / or an identifier associated with the communication interface 850) with a patient identifier, enabling the timestamp and / or duration data to be associated with the patient.

[0058] The generated time data can be used in various ways, for example, to predict the time until the end of dose delivery, to determine or estimate the total dispensed amount of the drug, to calculate the continuous and / or average flow rate of the drug during dose delivery, to remove the drug delivery device from the patient's skin (e.g., by detecting an increase in plunger speed), and to determine the backpressure during dose delivery. The drug delivery devices described herein may include one or more indicators such as audible, tactile, and / or visual indicators, and in combination with the collected and generated data, may provide feedback to the patient, such as increasing the dwell time so that it is known that a full dose has been delivered.

[0059] In addition to the switches described herein, the drug delivery devices according to the present disclosure may also include one or more environmental (e.g., temperature and / or humidity) sensors, a GPS unit, and / or a gyroscope (e.g., for determining the injection direction).

[0060] The present disclosure has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiments, but such details are for that purpose only, and it is to be understood that the present disclosure is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A digital module for an auto-injector, comprising: a housing having a distal end and a proximal end and configured to releasably engage with the auto-injector; a first circuit board received within the housing, the circuit board having a distal end and a proximal end; at least one switch; at least one processor in communication with the at least one switch; at least one communication interface; at least one power source; and a first circuit board including the above; and a digital module comprising the above.

2. The digital module according to claim 1, wherein the at least one switch is at least one mechanical switch and / or at least one optical sensor. The digital module according to claim 1.

3. The digital module according to claim 1, wherein the at least one switch is at least one mechanical switch and at least one optical sensor. The digital module according to claim 1.

4. The digital module according to claim 3, wherein the at least one mechanical switch is located distal to the at least one optical sensor. The digital module according to claim 3.

5. The digital module according to claim 3, wherein the at least one optical sensor is located distal to the at least one mechanical switch. The digital module according to claim 3.

6. The digital module according to claim 1, wherein the at least one circuit board is a printed circuit board. The digital module according to claim 1.

7. The digital module according to claim 1, wherein the housing defines a channel configured to receive the plunger body of the auto-injector. The digital module according to claim 1.

8. The digital module further comprises a second circuit board including at least one switch, at least one processor in communication with the at least one switch, at least one communication interface, and at least one power source, wherein the first circuit board and the second circuit board are received within the housing on opposite sides of the channel. The digital module according to claim 7.

9. An auto-injector, comprising: a housing having a distal end and a proximal end; a syringe including a barrel, a stopper, and a needle disposed at the distal end of the syringe, at least a portion of the syringe being located within the housing. ​ ​ ​ ​ A drive assembly including a drive member and a plunger body, wherein the drive assembly is configured to move the stopper into the barrel during operation of the drive assembly, and at least a part of the drive assembly is located within the housing, the drive assembly and, A needle cover having a pre-use position in which the needle is located within the needle cover, an operating position in which the needle cover is shifted proximally, thereby enabling the drive assembly to operate, and a post-use position in which the needle is located within the needle cover, the needle cover and, A digital module, A housing having a distal end and a proximal end and configured to releasably engage with the autoinjector, A first circuit board received within the housing, the circuit board having a distal end and a proximal end, At least one switch, At least one processor communicating with the at least one switch, At least one communication interface, At least one power source, Including, the first circuit board and, Including, the digital module and, Comprising, The at least one switch is actuated by the plunger body when the plunger body moves distally during operation of the drive assembly, and actuation of the at least one switch indicates the start and / or end of dose delivery. Autoinjector.

10. The at least one switch includes at least one proximal sensor and at least one distal sensor, actuation of the distal sensor indicates the start of dose delivery, and actuation of the distal sensor indicates the end of dose delivery. The autoinjector according to claim 9.

11. The plunger body includes a rack having a plurality of teeth, and the at least one switch detects movement of the plunger body based on the passage of one or more teeth. The autoinjector according to claim 9.

12. The plunger body further includes at least one first flange configured to actuate the at least one switch, and actuation of the at least one switch by the flange indicates the start of dose delivery. The autoinjector according to claim 9.

13. The plunger body includes at least one second flange configured to activate the at least one switch, and activation of the at least one switch by the flange indicates the end of dose delivery. The autoinjector according to claim 12. **Claim 14** At least one switch, At least one processor in communication with the at least one switch, At least one communication interface, At least one power source, further comprising a second circuit board including The first circuit board and the second circuit board are received within the housing on opposite sides of the channel. The autoinjector according to claim 9.

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