Reusable digital module for autoinjection devices

Abstract

Provided herein is a digital module for an automatic injection device, the digital module comprising a housing having a distal end and a proximal end and configured to releasably mate with an automatic injection device, and a first circuit board received within the housing, the circuit board has a proximal end and a distal end and includes 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

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

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

[0003] The present disclosure relates generally to a drug delivery device and, more particularly, to an automatic injection device. Background Art

[0004] Various types of automatic injection devices have been developed to allow for the administration or self-injection of drug solutions and other liquid therapeutic preparations by untrained personnel. Typically, these devices contain a reservoir prefilled with the liquid therapeutic preparation and some type of automatic needle injection mechanism that can be triggered by the user. Many of these devices, such as automatic injection devices, are designed so that during the assembly process of the device, the reservoir (such as a prefilled syringe) is assembled into the device. In addition to automatically deploying the needle injection mechanism, many drug delivery devices also automatically shield the needle after the device is used to prevent any accidental contact with the needle.

[0005] Such drug delivery devices traditionally lack features that allow a healthcare provider to automatically record or capture data showing proper administration of a drug. Ensuring timely, proper administration of certain drugs can be critical, particularly in situations such as evaluating new drugs in clinical trials, where accurate information is essential. It can 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.

[0006] While some devices provide the ability to communicate specific types of information, for example, as described in International Patent Application Publication Nos. WO 2016 / 087512, WO 2017 / 070391, WO 2018 / 111969, WO 2018 / 213837, WO 2021 / 094797 and U.S. Patent Application Publication Nos. 2019 / 0083708, 2019 / 0321555, and 2019 / 0344019, there remains a need in the art for a cost-effective, reusable device that accurately detects drug delivery and can communicate that drug delivery information to the appropriate stakeholders in a timely manner. Summary of the invention

[0007] A digital module for an automatic injection device is provided herein, the digital module comprising: a housing having a distal end and a proximal end and configured to releasably mate with the automatic injection device; and a first circuit board received in the housing, the first circuit board having a proximal end and a distal end and comprising at least one switch, at least one processor communicating with the at least one switch, at least one communication interface, and at least one power source.

[0008] In some 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 positioned distally of the at least one optical sensor. The at least one optical sensor may be positioned distally of 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 automatic injection device. 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 automatic injection device, the automatic injection device comprising: a housing having a proximal end and a distal end; a syringe, the syringe comprising a barrel, a stopper, and a needle arranged at the distal end of the syringe, at least a portion of the syringe being positioned within the housing; a drive assembly comprising a drive member and a plunger body, the drive assembly being configured to move the stopper within the barrel when the drive assembly is actuated, at least a portion of the drive assembly being positioned within the housing; a needle cover, the needle cover having a pre-use position, an actuation position, and a post-use position, in the pre-use position, in which the needle is positioned within the needle cover, and in the actuation position, the needle cover has been displaced proximally to allow the drive assembly to be actuated a digital module comprising: a housing having a distal end and a proximal end and being configured to releasably mate with the housing of the automatic injection device; and a first circuit board received in the housing of the digital module, the first circuit board having a proximal end and a distal end and comprising 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 activated by the plunger body when the plunger body moves distally during actuation of the drive assembly, and wherein activation of the at least one switch indicates the start of dose delivery and / or the end of dose delivery.

[0011] In certain configurations, the at least one switch comprises at least one proximal sensor and at least one distal sensor, and wherein activation of the proximal sensor indicates the start of dose delivery, and activation of the distal sensor indicates the end of dose delivery. The plunger body may comprise a rack having a plurality of teeth, and wherein 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 comprises at least a first flange, the first flange being configured to actuate the at least one switch, and wherein the first flange actuating the at least one switch indicates the start of dose delivery.

[0012] The plunger body may include at least a second flange, the second flange being configured to actuate the at least one switch, and wherein the second flange actuates the at least one switch to indicate the end of dose delivery. The automatic injection device may also include a second circuit board, the 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] Figure 1is a side view of a drug delivery device with a digital module according to a non-limiting embodiment described herein;

[0014] Figure 2 is a cross-sectional view of a drug delivery device with a digital module according to a non-limiting embodiment described herein;

[0015] Figure 3 is a perspective view of a digital module according to a non-limiting embodiment described herein;

[0016] Figure 4 is a perspective view of a plunger body and a digital module according to a non-limiting embodiment described herein;

[0017] Figure 5 is a perspective view of a plunger body and a digital module according to a non-limiting embodiment described herein;

[0018] Figure 6 is a top view of a plunger body and a digital module according to a non-limiting embodiment described herein;

[0019] Fig. 7A and 7B is a partial top view of a drug delivery device with a digital module according to a non-limiting embodiment described herein;

[0020] Figure 8 is a perspective view of a plunger body and a digital module according to a non-limiting embodiment described herein;

[0021] Fig. 9 is a perspective view of a plunger body and a digital module according to a non-limiting embodiment described herein;

[0022] Fig.10 is a top view of a plunger body and a digital module according to a non-limiting embodiment described herein;

[0023] Fig.11A and 11B is a partial top view of a drug delivery device with a digital module according to a non-limiting embodiment described herein;

[0024] Fig.12 is a schematic diagram of the operation of a digital module according to a non-limiting embodiment described herein;

[0025] Figures 13A-13D is a schematic diagram of the operation of a digital module according to a non-limiting embodiment described herein;

[0026] Fig.14 is a partial side view of a digital module according to a non-limiting embodiment described herein;

[0027] Fig.15 diagrams of non-limiting embodiments or aspects of environments in which the systems, apparatuses, and / or methods described herein may be implemented; and

[0028] Fig.16 for Fig.15 A diagram of a non-limiting embodiment or aspect of components of one or more devices. DETAILED DESCRIPTION

[0029] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and substitutes will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the present invention.

[0030] For the purpose of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the present invention when the present invention has the orientation in the accompanying drawings. However, it should be understood that the present invention may take various alternative variations, unless otherwise expressly specified to the contrary. It should also be understood that the specific devices illustrated in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0031] It should be understood that any numerical range recited herein is intended to include all values ​​and subranges contained therein. For example, a range of "1 to 10" is intended to include all subranges between the recited minimum value of 1 and the recited maximum value of 10 (and including the recited minimum value of 1 and the recited maximum value of 10), i.e., having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10.

[0032] As used herein, the term "communication" refers to the reception or transmission of one or more signals, messages, commands, or other types of data. A unit (e.g., any device, system, or component thereof) communicating with another unit means that the unit can directly or indirectly receive data from another unit and / or send data to another unit. This can refer to a direct or indirect connection that is wired and / or wireless in nature. In addition, two units can communicate with each other, even if the transmitted data may be modified, processed, relayed, and / or routed between the first and second units. For example, a first unit can communicate with a second unit, even if the first unit passively receives data and does not actively send data to the second unit. As another example, if an intermediate unit processes data from a unit and sends processed data to a second unit, the first unit can communicate with the second unit. It should be understood that many other arrangements are also possible. Any known electronic communication protocol and / or algorithm may 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), and the like known to those skilled in the art. In some non-limiting embodiments, a message may refer to a network data packet (e.g., a data packet and / or the like) containing data.

[0033] As used herein, the term "computing device" may refer to one or more electronic devices configured to process data. In some examples, the computing device may include components necessary to receive, process, and output data, such as a processor, a display, a memory, an input device, a network interface, and / or the like. The computing device may be a mobile device. As an example, the 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, and / or the like), a personal digital assistant (PDA), and / or other similar devices. The computing device may also be a desktop computer or other form of non-mobile computer, including a server, and a distributed computing model, such as edge computing.

[0034] Provided herein is a digital module for a drug delivery device, a drug delivery device including such a digital module, and a system and method for monitoring drug delivery of the drug delivery device using such a drug delivery device. The devices, systems, and methods described herein improve conventional devices and methods for determining the administration of a drug by enabling relevant stakeholders to monitor drug delivery in a timely and accurate manner in a cost-effective manner, for example, improving clinical trials of newly developed drugs with more robust data management solutions.

[0035] International Patent Application Publication Nos. WO 2020 / 173991, WO 2020 / 173992, WO 2020 / 173993, WO 2020 / 173994, and WO 2020 / 173995 are incorporated herein by reference in their entirety.

[0036] Steering Figure 1 and Figure 2 , showing a drug delivery device 100. The drug delivery device 100 can include a first subassembly 110, a second subassembly 140, and a syringe 116. The first subassembly 110 can include a lower housing shell 112, a cap 114, a syringe holder 118, a needle cover 124, and a box body 128. The second subassembly 140 can include a drive assembly, the drive assembly including a plunger body 150, the plunger body 150 including a plunger rod 152 and a spring guide member 154, the spring guide member including a drive member 156 and a drive opening 158. The second subassembly 140 can further include a motor body 159, a rod actuation member 130, and an upper housing shell 142. The syringe 116 can be received by the syringe holder 118 and includes a barrel 117, a stopper 122, a needle 120, and a rigid needle shield (RNS) 126. Although RNS is used, other suitable needle shield arrangements can also be used. The lower housing shell 112, the box body 128, and the upper housing shell 142 generally form a housing for receiving the various components of the drug delivery device 100, but other suitable housing arrangements may be utilized. The first subassembly 110 and the second subassembly 140 may be secured to each other by locking clips during assembly, but other suitable arrangements may also be used. The drug delivery device 100 may be an automatic injection device, but the features described herein may be incorporated into other suitable drug delivery devices.

[0037] The drug delivery device 100 is configured to automatically deliver a dose of a drug from the syringe 116 to the patient when the drug delivery device 100 is actuated. More specifically, when the drug delivery device 100 is actuated, the drive assembly is configured to engage the stopper 122 of the syringe 116, move the syringe 116 so that the needle 120 pierces the patient's skin, and move 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 actuation position, an injection position, and a post-use position, as described in International Patent Application Publication Nos. WO 2020 / 173991, WO 2020 / 173992, WO 2020 / 173993, WO 2020 / 173994, and WO 2020 / 173995. The needle cover 124 is configured to protect the needle 120 of the syringe 116 from the patient when the drug delivery device 100 is in the pre-use and post-use positions. In particular, the needle cover 124 can be moved between the pre-use position, the actuation position, and the post-use position, wherein the spring 125 biases the needle cover 124 toward the pre-use position and the post-use position. The spring 125 can be positioned between the needle cover 124 and the syringe holder 118, but other suitable arrangements can also be used. The rod actuation member 130 can be moved between a locked position and a released position, in which the movement of the drive assembly is blocked, and in which the movement of the drive assembly is allowed. More specifically, the rod actuation member 130 can rotate around the rotation axis between the locked position and the released position. When the rod actuation member 130 is in the locked position, the rod actuation member 130 engages with the motor body 159 and the drive assembly to prevent the movement of the drive assembly. When the lever actuation member 130 is in the released position (which may be achieved by pressing the needle cover 124 against the patient's skin at the injection site, causing the needle cover to be displaced proximally into the lower housing shell 112), the lever actuation member 130 is disengaged from the motor body 159, thereby allowing the drive assembly to move toward the syringe 116. The axis of rotation of the lever actuation member 130 extends perpendicular to the longitudinal axis of the drug delivery device 100, although other suitable arrangements may be utilized.

[0038] Reference again Figure 1 and Figure 2, the drive assembly includes a plunger body 150 having a plunger rod portion 152 and a drive member 156. The drive member 156 can be a compression spring received in a drive opening 158 defined by the plunger body 150, but other suitable drive members can be utilized, including but not limited to compressed gas, electric motors, hydraulic pressure, 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 subassembly 140 toward the first subassembly 110. The plunger body 150 defines a rod opening that receives the rod actuation member 130 and defines an axis of rotation of the rod actuation member 130. When the rod actuation member 130 is in the locked position, the rod actuation member 130 prevents movement of the plunger body 150 by the engagement of the rod actuation member 130 with the motor body 159. When the rod actuation member 130 is rotated from the locked position to the released position, the rod actuation member 130 is disengaged from the motor body 159, thereby allowing the drive member 156 to move the plunger body 150 and the plunger rod 152 toward the first subassembly 110. The plunger rod 152 and the drive member 156 are spaced apart and parallel to each other and extend in the longitudinal direction of the drug delivery device 100.

[0039] The drive assembly further includes a spring guide member 154 that is fixed to the upper housing shell 142 and received in the drive opening 158 of the plunger body 150. The drive member 156 is received by the spring guide member 154 so that the drive member 156 is positioned between the plunger body 150 and the spring guide member 154. The drive assembly may also include a plunger rod cover that receives the plunger rod 152 of the plunger body 150. The plunger rod cover may be configured to guide the plunger rod 152 to be inserted into the barrel 117 of the syringe 116 and engage the stopper 122 to dispense the drug from the barrel 117 of the syringe 116. The plunger rod cover and the plunger rod 152 may be formed integrally or as separate components.

[0040] The plunger body 150 of the drive assembly may also include an audio indicator member 160 configured to provide an audible indication to the user when the drug delivery device 100 is converted to the post-use position. The audio indicator member 160 may be configured to engage one or more ribs of the box body 128 when the drug delivery device 100 is in the injection position, thereby deflecting the audio indicator member 160. When the drug delivery device 100 is converted from the injection position to the post-use position, the audio indicator member 160 may disengage from the rib(s) of the box body 128 and contact the lower housing shell 112 to provide an audible click, but the audio indicator member 160 may also contact other suitable parts of the drug delivery device 100 to provide an audible indication.

[0041] Continue to refer Figure 1 , the drug delivery device 100 may further include a digital module 180. The digital module 180 may be reversibly attached to the housing of the drug delivery device 100, for example, to the upper housing shell 142. Figure 3 and Figure 8 , the digital module may include a housing 182, and the digital module 180 may be reversibly attached to the drug delivery device 100, for example by a hinged connection, a sliding 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.

[0042] 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. Figure 3-13D Various non-limiting embodiments of the arrangement of the components of the digital module 180 are shown. In a non-limiting embodiment, the circuit board (one or more) can be a printed circuit board, a flexible substrate for printed electronics, and the like known in the art. In a non-limiting embodiment, more than one circuit board is included, and the circuit boards are connected to each other, optionally in electronic communication with each other. In a non-limiting embodiment, the switch can 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 independently, and can communicate with one or more processors on the circuit board (one or more). In a non-limiting embodiment, the digital module 180 is reusable and can use a suitable rechargeable or replaceable power supply.

[0043] refer to Figure 3-7B, shows a non-limiting embodiment of a digital module 180, which includes a housing 182, a circuit board 184, a power supply 186, a mechanical switch 188 (one or more), and an optical sensor (one or more) (e.g., an optical switch) 190. Suitable mechanical switches are known to those skilled in the art and may include the ESE13V05 from Panasonic (Kadoma, Osaka, Japan), and the HDT0001 switch produced by C&K (Waltham, MA). Suitable optical sensors are known to those skilled in the art and may include reflective encoders, such as the AEDR-9820 from Broadcom (San Jose, CA), slotted light gate sensors, such as the TCUT1300X01 from Vishay (Malvern, PA), and reflective optical sensors, such as the OPB9000 from TT Electronics (Woking, United Kingdom). In a non-limiting embodiment, a reflective code strip can be applied to the plunger body 150 and can thus 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 code strips from Photo Solutions (Wilsonville, OR), Meltec (Nagareyama, Nagareyama City, Chiba, Japan), GM Nameplate (Seattle, WA), and pwb (Eisenach, Germany). In a non-limiting embodiment (discussed below), a rack can be applied to the plunger body 150, or co-molded as part of the plunger body 150, and the rack can include one or more teeth and / or flanges to actuate the switches 188 and / or 190.

[0044] exist Figure 3-7B In the illustrated embodiment, each circuit board 184 includes two switches, and the optical sensor 190 is arranged distal to the mechanical switch 188. As described above, any suitable number, combination, and arrangement of switches may be used. In a non-limiting embodiment, at least one switch is positioned so that it is actuated about 2.2 mm, about 2 mm, about 1.5 mm, about 1.1 mm, or about 1 mm, including all values ​​and sub-ranges therebetween, before the stopper 122 reaches its most distal position (e.g., the end of dose delivery). Figure 3-7B In a non-limiting embodiment, the circuit board 184 is arranged in the housing 182 in a manner to provide a passage between the two circuit boards, wherein one or more switches 188, 190 are arranged facing the passage. Figure 4-7BAs shown in , this allows components of the drive assembly of the drug delivery device 100 to be received in the channel and interact with the switch.

[0045] Now turn to Figure 4-6 , showing the plunger body 150 and the digital module 180 (wherein the housing 182 is 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 teeth 164 may be arranged on the rack 162 in any suitable configuration. In a non-limiting embodiment, the 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. It will be understood by those skilled in the art that the number of optical switches 190 and the spacing between the teeth 164 can be modified to enhance the resolution or robustness of the switches and the information they transmit. The rack 162 can be arranged on the plunger body 150 in a manner that allows one or more teeth 164 to interact 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 arranged in a manner that allows the one or more flanges 166 to interact with the one or more mechanical switches 188.

[0046] Reference now Figure 7A-7B , showing the position before use relative to the digital module 180 ( Fig. 7A ) and the post-use position ( Figure 7B ) in an image of the drug delivery device 100. Fig. 7A As shown in , before the drive assembly is actuated, the rack 162 is in the proximal position and the mechanical switches 188a, 188b have not yet been actuated. After the drive assembly is actuated, the plunger body 150 with the rack 162 begins to move distally. One or more flanges 166a, 166b, 166c contact one or more mechanical switches 188a, 188b, causing the digital module 180 to wake up and begin recording data (as will be described in more detail below). In a non-limiting embodiment, the digital module 180 may include one or more gyroscopes or other positioning sensors so that the digital module 180 is awakened when the user picks up the drug delivery device. As will be described in more detail below (see Figure 12-15), a switch may be arranged, and a processor included on 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 the drug delivery process. In a non-limiting embodiment, digital module 180 may include one or both arrangements. For example, in a non-limiting embodiment, digital module 180 may include two arrangements, such as Figure 7A-7B As shown in Figure 7A-7B In the illustrated embodiment, one or more teeth 164 on the rack 162 interact with one or more optical sensors 190a, 190b (reflective optical sensors 190 in the illustrated embodiment) so that data can be continuously recorded during the drug delivery process. Figure 7A-7B In a non-limiting embodiment, optical sensor 190b senses the passage of flange 166c, which indicates the end of drug delivery.

[0047] Steering Figure 8-11B , shows another non-limiting embodiment of a digital module 180, the digital module comprising a housing 182 (only in Figure 8 ), a circuit board 184, a power supply 186, a mechanical switch 188 (one or more), and an optical sensor 190 (one or more). Figure 8-11B In a non-limiting embodiment, the circuit boards 184 are arranged in the housing 182 in a manner that provides a passage between the two circuit boards 184, wherein one or more switches 188, 190 are arranged facing the passage. Figure 8-11B As shown in , this allows components of the drive assembly of the drug delivery device 100 to be received in the channel and interact with the switch.

[0048] Now turn to Figure 9-10 , showing the plunger body 150 and the digital module 180 (wherein the housing 182 is 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 arranged on the plunger body 150 in a manner that allows the one or more teeth 164 to interact 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 arranged in a manner that allows the one or more flanges 166 to interact with one or more mechanical switches 188. Figure 8-11B In a non-limiting embodiment, the optical sensor is a slotted optical sensor arranged such that one or more teeth 164 of the rack 162 pass between two opposing sensors 190 .

[0049] Reference now Figures 11A-11B, showing the position before use relative to the digital module 180 ( Fig.11A ) and the post-use position ( Fig. 11B ) in an image of the drug delivery device 100. Fig.11A As shown in FIG. 1 , before the drive assembly is actuated, the rack 162 is in the proximal position and the mechanical switches 188a, 188b have not yet been actuated. After the drive assembly is actuated, the plunger body 150 with the rack 162 begins to move distally. One or more flanges 166a, 166b, 166c contact one or more mechanical switches 188a, 188b, causing the digital module to wake up and begin recording data (as will be described in more detail below). As will be described in more detail below (see FIG. 1 ), the plunger body 150 with the rack 162 begins to move distally. Figure 12-15 ), a switch may be arranged and a processor included on 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 the drug delivery process. In a non-limiting embodiment, both arrangements may be included in the same digital module, such as Figure 7A-7B As shown in Figures 11A-11B In the illustrated embodiment, one or more teeth 164 on the rack 162 interact with one or more optical sensors 190a, 190b (slotted optical sensors in the illustrated embodiment) so that data can be continuously recorded during the drug delivery process. Figures 11A-11B In a non-limiting embodiment, the mechanical switch 188c falls off the end of the rack 162 after the proximal end of the rack 162 passes, indicating the end of drug delivery.

[0050] refer to Figure 12-13D , shows a non-limiting example of an 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. As described above, the arrangement of switches 188, 190 may be modified to provide only an indication of the start of a dose and an end of a dose, to provide an indication of the start of a dose, an indication of the end of a dose, and continuous monitoring of the dose as it is delivered, or any combination thereof. Fig.12 In a non-limiting embodiment, when drug delivery begins, the mechanical switch 188 is actuated by the flange 166. This can wake up a processor disposed on one or more circuit boards. Thereafter, as the rack 162 moves distally with the plunger body 150 to expel the drug from the syringe 116, the optical sensor 190 detects the passage of the teeth 164. Thus, as each tooth 164 passes by and is sensed by the optical switch 190, Fig.12 Embodiments may provide an indication of the start of dose delivery, as well as continuous monitoring of the dose.

[0051] Now turn to Figures 13A-13D , showing further non-limiting examples of arrangements of switches 188, 190 and interactions between the arranged switches 188, 190 and the teeth 164 and / or flange 166 of the plunger body. Fig.13A A non-limiting embodiment is shown in which only a single optical switch 190 is used to provide continuous monitoring throughout the dose delivery process. Fig. 13B The use of two optical switches 190 is shown, arranged so that the switches are 90° out of phase to provide continuous monitoring throughout the dose delivery process. This arrangement can provide enhanced resolution and can also be suitable for determining the direction of travel of the plunger body 150. Fig. 13C The use of two optical switches 190 is shown with minimal overlap to provide continuous monitoring throughout the dose delivery process. The most proximal switch 190 (SOD) monitors the first half of the dose delivery, while the most distal switch 190 (EOD) monitors the second half of the dose delivery. Fig.13D The use of two optical switches is shown, which overlap to provide continuous monitoring throughout the dose delivery process. The most proximal switch 190 (SOD) monitors dose delivery, and the most distal switch 190 (EOD) provides enhanced resolution near the end of dose delivery as the plunger body 150 slows (due to less force provided by the drive member).

[0052] Steering Fig.14 , a non-limiting embodiment is shown in which the circuit board 184 includes a camera 192 instead of (or in addition to) the 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 a camera 192 is illustrated, it will be appreciated by those skilled in the art 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 time data may be generated and transmitted therefrom, as described below.

[0053] Reference now Fig.15 , a diagram showing an example environment in which the apparatus, systems, and / or methods described herein may be implemented. Fig.15As shown in FIG. 8 , the environment may 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 may be interconnected (e.g., connected for communication) via a wired connection, a wireless connection, or a combination of wired and wireless connections.

[0054] The drug delivery device 800, which may be an automatic injection device as described herein, may include a digital module 810 as described above, including a first switch 820, optional additional switches 830n, a processor 840, and a communication interface 850. The drug delivery device 800 may be configured to communicate with a user device 802 (e.g., a computing device as described herein).

[0055] The communication network 806 may include one or more wired and / or wireless networks. For example, the communication network 806 may include a Bluetooth 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, a fiber-optic-based network, a cloud computing network and / or the like, and / or a combination of some or all of these or other types of networks.

[0056] The user device 802 may be a computing device as described herein, and in some non-limiting embodiments, may be a smartphone, a smart watch, a tablet computer, a laptop computer, a desktop computer, or other computing device. The user device 802 may be programmed or configured to communicate with the healthcare system 804, for example, via a communication network 806, for example, via an application executable on the user device 802, such as a mobile application.

[0057] The healthcare system 804 may include a server, a group of servers, and / or other similar devices. More than one healthcare system 804 may be provided, such as a system associated with a device manufacturer, a system associated with a pharmaceutical manufacturer, a system associated with a healthcare provider, a system associated with a clinical study, a system associated with a government agency, and / or a system associated with a research sponsor (e.g., a sponsor of a clinical trial).

[0058] Reference now Fig.16, a diagram showing exemplary components of an exemplary computing device 900 that may be used in the systems, devices, and methods described herein. Such a computing device 900 may 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. Fig. 9 As shown in , computing device 900 may include a bus 902 , a processor 904 , a memory 906 , a storage component 908 , an input component 910 , an output component 912 , and / or a communication interface 914 .

[0059] The bus 902 may include components that allow communication between components of the computing device 900. In some non-limiting embodiments, the processor 904 may be implemented in hardware, software, or a combination of hardware and software. For example, the 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), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform a function (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), and / or the like). The 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 the processor 904.

[0060] The storage component 908 may store information and / or software related to the operation and use of the computing device 900. For example, the 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 cassette, a magnetic tape, and / or another type of computer-readable medium, and corresponding drives.

[0061] Input components 910 may include components that allow computing device 900 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, buttons, switches, a microphone, and / or the like). Additionally or alternatively, input components 910 may include sensors for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, a microphone, an environmental sensor (e.g., temperature, humidity, etc.), and / or the like). Output components 912 may include components that provide output information from the computing device (e.g., a display, a speaker, one or more light emitting diodes (LEDs), a tactile indicator, and / or the like).

[0062] The communication interface 914 may include transceiver-like components (e.g., transceivers, separate receivers, and transmitters, etc.) that enable the device to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication interface 914 may allow the computing device 900 to send information 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, Interface, cellular network interface, Bluetooth interface and / or the like. In a non-limiting embodiment, the communication interface 914 is not operated by near field communication. Suitable 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 smart phone, a smart watch, a PDA, a tablet computer, etc.) may include encryption, for example, using a secure socket layer (SSL) (e.g., by using a public key / private key pair as known in the art). Additional security protocols are disclosed in, for example, U.S. Patents Nos. 9,445,264 and 9,463,325, the contents of which are incorporated herein by reference in their entirety. In the non-limiting embodiments described herein, the communication interface 914 is disposed on the plunger rod. In a non-limiting embodiment, the communication interface 914 is configured to send data, but is not configured to receive data sent by a computing device (e.g., a user's smart phone).

[0063] The computing device may perform one or more processes described herein. The computing device may perform these processes based on a processor 904 that executes software instructions stored by a computer-readable medium such as a memory 906 and / or storage component 908, and / or is 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 storage device. A non-transitory storage device includes storage space located within a single physical storage device or storage space distributed on multiple physical storage devices.

[0064] The software instructions may be read from another computer-readable medium or another device into the memory 906 and / or storage component 908 via the communication interface 914. When executed, the software instructions stored in the memory 906 and / or storage component 908 may cause the processor 904 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Therefore, the embodiments described herein are not limited to any specific combination of hardware circuitry and software.

[0065] refer to Fig.15In a non-limiting embodiment, the drug delivery device 800 includes a digital module 810 as described above, the digital module including a first switch 820 and an additional switch 830n in communication with a processor 840. The processor 840 is in communication with a communication interface 850. The digital module 810 can thus communicate with a user's computing device 802 (such as a smartphone) through the communication interface 850, the computing device having 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.

[0066] In a non-limiting embodiment, the digital module 810 communicates with the user's computing device 802 and / or the healthcare system 804 in a one-way manner, for example, the digital module 810 can only send data to the user device 802 and / or the healthcare system 804, but cannot receive data from the user device 802 and / or the healthcare system 804. In a non-limiting embodiment, a processor associated with the user device 802 can be programmed or configured to place a communication interface associated with the user device 802 in a sleep mode, for example based on a mobile application stored in a memory and / or storage component of the user device 802, until the communication interface 850 sends data from the digital module 810.

[0067] In a non-limiting embodiment, the mechanical switch 188(s) may be used to determine the assembly time of the drug delivery device 100, for example, the switch 188(s) may be actuated during the assembly process, and the assembly time data may be recorded and processed as described below.

[0068] In a non-limiting embodiment, when the drug delivery device 800 is actuated, the first switch 820 is activated. Since the first switch 820 is in communication with the processor 840, the processor 840 receives the 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, wherein the first time data optionally has 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 is also transmitted, such as data related to the power level of the power source(s), a counter value, and / or other data related to the contained drug(s) (e.g., expiration date, batch number, manufacturer, etc.) and / or other data related to the function of the drug delivery device 800 (e.g., location as determined by GPS, device orientation, etc.). 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 may include that any message received from the drug delivery device 800 includes one or more of the following: an identifier associated with the communication interface 850, an identifier associated with the drug delivery device 800, and / or a first identifier associated with activation of the first switch 820 (e.g., associated with a first signal). In a non-limiting embodiment, if after checking, the message is the first transmitted message including the first identifier, indicating that the message has not been previously transmitted by the drug delivery device 800, the user device 802 and / or the healthcare system 804 accepts the message received from the drug delivery device when the first switch 820 is activated. In a non-limiting embodiment, if after checking, the combination of the first identifier and the identifier associated with the drug delivery device 800 and / or the communication interface 850 has not been previously transmitted to the user device 802 and / or the healthcare system 804, the user device 802 and / or the healthcare system 804 accepts the message.

[0069] In a non-limiting embodiment, the user device 802 may generate a first timestamp based on the first time data by a processor (e.g., processor 904), and may transmit the first timestamp (optionally, with one or more identifiers associated with the drug delivery device 800 as described herein) to the healthcare system 804. 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, such as those embodiments that provide continuous monitoring, the drug delivery device 800 continuously collects and optionally continuously transmits data during the drug delivery process. In such an embodiment, the above operations may be repeated, for example, a second, third, etc. timestamp may be generated based on the second, third, etc. time data, and such data and / or timestamps (optionally with any other data described herein) may be transmitted to the user device 802 and / or the healthcare system 804.

[0070] In a non-limiting embodiment, when the drug delivery process is nearing the end, the first switch 820 or the additional switch (optical or mechanical) 830n is actuated. Since the first switch 820 or the additional switch 830n communicates with the processor 840, as described above, the processor 840 receives a signal from the first switch 820 or the additional switch 830n and generates final time data. The processor then transmits the final time data to the user device 802 using the communication interface 850, and the final time data optionally has one or more identifiers (e.g., a device identifier and / or an identifier associated with the communication interface 850). 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 accepts the data transmitted by the drug delivery device 800 only if certain conditions are met. In a non-limiting embodiment, the one or more conditions may include any message received from the drug delivery device 800 that includes one or more of the following: an identifier associated with the communication interface 850, an identifier associated with the drug delivery device 800, and / or a second identifier associated with activation of the additional switch 830n. In a non-limiting embodiment, the user device 802 and / or the healthcare system 804 accepts the message received from the drug delivery device when the additional switch 830n is activated (and, in a non-limiting embodiment, reestablishes communication between the drug delivery device 800 and the user device 802 and / or the healthcare system 804), because such a message is the first transmitted message that includes the second identifier, indicating that the message has not been previously transmitted by the drug delivery device 800. In a non-limiting embodiment, the user device 802 and / or the healthcare system 804 may generate a final timestamp based on the final time data using a processor (e.g., processor 904), and in the case of the user device 802, the final timestamp (optionally with one or more identifiers associated with the drug delivery device 800 as described herein) may be transmitted to the healthcare system 804. In a non-limiting embodiment, when the final timestamp is transmitted to the healthcare system 804 , the user device 802 terminates any connection with the digital module 810 .

[0071] In a non-limiting embodiment, the user device 802 transmits the final timestamp and / or duration data to the healthcare system 804 (optionally with one or more identifiers associated with the drug delivery device 810 as described herein). In a non-limiting embodiment, the healthcare system can verify the timestamp data and / or duration data, such as by comparing the timestamp data, duration data, plunger rod travel data (e.g., velocity and / or acceleration), and / or a combination thereof to a predetermined range / value for each. In a non-limiting embodiment, data that falls outside of the predetermined range can be flagged for follow-up, or a message can be sent to the user device 802 to indicate the problem.

[0072] In a non-limiting embodiment, the healthcare system 804 can communicate with one or more additional healthcare systems 804. For example, one healthcare system can be maintained by a device manufacturer and can communicate with a healthcare system maintained by a study sponsor, a drug manufacturer, etc. In a non-limiting embodiment, the 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), can be transmitted from the device manufacturer system to the study sponsor or drug manufacturer system, where one or more databases can store data associating the one or more identifiers (e.g., a device identifier and / or an identifier associated with the communication interface 850) with a patient identifier, thereby allowing the timestamp and / or duration data to be associated with the patient.

[0073] The generated time data can be used in various ways, for example, to predict the time before the end of dose delivery, to determine or estimate the total dispensed volume of the drug, to calculate the continuous and / or average flow rate of the drug during dose delivery, the removal of the drug delivery device from the patient's skin (e.g., by detecting an increase in plunger speed), and to determine the back pressure during dose delivery. The drug delivery device as described herein can be equipped with one or more indicators, such as auditory, tactile, and / or visual indicators, which can be combined with the collected and generated data to provide feedback to the patient, such as increasing the dwell time to let the patient know that a full dose has been delivered.

[0074] In addition to switches as described herein, a drug delivery device according to the present disclosure may also include one or more environmental (eg, temperature and / or humidity) sensors, a GPS unit, and / or a gyroscope (eg, for determining injection orientation).

[0075] Although the present disclosure has been described in detail based on what are currently considered to be the most practical and preferred embodiments for the purpose of illustration, it should be understood that such details are used only for this purpose and that the present disclosure is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should 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 automatic injection device, comprising: a housing having a distal end and a proximal end and configured to releasably mate with an automatic injection device; as well as a first circuit board received in the housing, the first circuit board having a proximal end and a distal end and comprising: 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 supply.

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.

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.

4. The digital module according to claim 3, wherein: The at least one mechanical switch is positioned distally from the at least one optical sensor.

5. The digital module according to claim 3, wherein: The at least one optical sensor is positioned distally from the at least one mechanical switch.

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

7. The digital module according to claim 1, wherein: The housing defines a channel configured to receive a plunger body of the automatic injection device.

8. The digital module according to claim 7, further comprising a second circuit board, wherein the second circuit board comprises: at least one switch; at least one processor in communication with the at least one switch of the second circuit board; at least one communication interface; as well as At least one power supply, Wherein the first circuit board and the second circuit board are received in the housing on opposite sides of the channel.

9. An automatic injection device, comprising: a housing having a proximal end and a distal end; a syringe comprising a barrel, a stopper, and a needle disposed at a distal end of the syringe, at least a portion of the syringe being positioned 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 when the drive assembly is actuated, at least a portion of the drive assembly being positioned 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 has been displaced proximally to permit the drive assembly to be actuated, and a post-use position in which the needle is positioned within the needle cover; as well as Digital modules, including: a housing of the digital module having a distal end and a proximal end and configured to releasably mate with the housing of the automatic injection device; and a first circuit board received within the housing of the digital module, the first circuit board having a proximal end and a distal end and comprising: 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 supply, wherein the at least one switch is activated by the plunger body when the plunger body is moved distally during actuation of the drive assembly, and wherein activation of the at least one switch indicates the start of dose delivery and / or the end of dose delivery.

10. The automatic injection device of claim 9, wherein: The at least one switch comprises at least one proximal sensor and at least one distal sensor, and wherein activation of the proximal sensor indicates the start of dose delivery and activation of the distal sensor indicates the end of dose delivery.

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

12. The automatic injection device according to claim 9, wherein: The plunger body further comprises at least a first flange, the first flange being configured to actuate the at least one switch, and wherein the at least one switch is actuated by the first flange to indicate the start of dose delivery.

13. The automatic injection device according to claim 12, wherein: The plunger body comprises at least a second flange configured to actuate the at least one switch, and wherein actuation of the at least one switch by the second flange indicates end of dose delivery.

14. The automatic injection device of claim 9, further comprising a second circuit board, the second circuit board comprising: at least one switch; at least one processor in communication with the at least one switch of the second circuit board; at least one communication interface; as well as At least one power supply, Wherein the first circuit board and the second circuit board are received within the housing of the digital module on opposite sides of a channel.

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