Sensor assembly and system

Abstract

A sensor assembly for an injection device may include a disposable label and / or a reusable housing.SOLUTION: The disposable label may be configured to be affixed to an injection device and to include an electrically conductive trace. The first portion of the electrically conductive trace may be configured to be altered in response to a first operation of the injection device. The reusable housing may be removably coupled to the disposable label and may include a processor and / or a wireless communication device. The processor may be removably electrically coupled to the electrically conductive trace and may be configured to be activated in response to a modification of the first portion of the electrically conductive trace. The wireless communication device can be configured to wirelessly communicate information related to the modification of the first portion of the electrically conductive trace to a computing device. The system may include a sensor assembly and an injection device.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to sensor assemblies and systems. [Background technology]

[0002] 1. Field The present application relates generally to a sensor assembly for an injection device, and in non-limiting embodiments or aspects, to a sensor assembly for automatically capturing and communicating information related to use of the injection device.

[0003] 2.Technical considerations A wide variety of injection devices for injecting fluids are currently commercially available, but many of these devices do not provide any mechanism for capturing and / or transmitting compliance observation data and / or other information related to use of the injection device. Summary of the Invention

[0004] Thus, what is provided is an improved system, device, product, apparatus, and / or method for capturing and / or transmitting compliance observation data and / or other information related to the use of an injection device.

[0005] According to certain non-limiting embodiments or aspects, provided is a sensor assembly for an injection device, the sensor assembly including: a disposable label configured to be affixed to the injection device, the disposable label including an electrical conductive trace configured to alter a first portion of the electrical conductive trace in response to an alteration of the first portion of the injection device; and a reusable housing removably coupled to the disposable label, the reusable housing including a processor removably electrically coupled to the electrical conductive trace, the processor configured to be activated in response to the alteration of the first portion of the electrical conductive trace; and a wireless communication device configured to wirelessly communicate information related to the alteration of the first portion of the electrical conductive trace to a computing device.

[0006] According to certain non-limiting embodiments or aspects, provided is a system including an injection device; a disposable label affixed to the injection device, the disposable label including an electrical conductive trace configured to alter a first portion of the electrical conductive trace in response to a first operation of the injection device; and a reusable housing removably coupled to the disposable label, the reusable housing including a processor removably electrically coupled to the electrical conductive trace, the processor configured to be activated in response to the alteration of the electrical conductive trace; and a wireless communication device configured to wirelessly communicate information related to the alteration of the electrical conductive trace to a computing device.

[0007] Further embodiments or aspects are described in the following numbered sections.

[0008] Section 1. A sensor assembly for an injection device, the sensor assembly comprising: a disposable label configured to be affixed to the injection device, the disposable label including an electrical conductive trace, a first portion of the electrical conductive trace configured to be altered in response to a first portion of the injection device; and a reusable housing removably coupled to the disposable label, the reusable housing including a processor removably electrically coupled to the electrical conductive trace, the processor configured to be activated in response to the alteration of the first portion of the electrical conductive trace; and a wireless communication device configured to wirelessly communicate information related to the alteration of the first portion of the electrical conductive trace to a computing device.

[0009] Section 2. The sensor assembly of clause 1, wherein the disposable label includes a plurality of first conductive pads electrically coupled to the electrical conductive traces, the reusable housing includes a plurality of spring contacts electrically coupled to the processor and removably electrically coupled to the plurality of first conductive pads, and the reusable housing includes a rigid deformable clip configured to clip onto an exterior surface of the injection device.

[0010] Section 3. The sensor assembly of any of clauses 1 and 2, wherein the disposable label includes at least one connector extending from the disposable label, the reusable housing includes at least one opening into which the at least one connector is received, and the at least one connector includes a plurality of first electrical connectors electrically coupled to the electrically conductive traces and removably electrically coupled to a plurality of second electrical connectors in the at least one opening, the plurality of second electrical connectors electrically coupled to the at least one processor.

[0011] Section 4. The sensor assembly of any of sections 1 to 3, wherein the at least one connector includes a plurality of connectors, and the at least one opening includes a plurality of openings corresponding to the plurality of connectors.

[0012] Section 5. The sensor assembly of any of sections 1 to 4, wherein each of the connectors of the plurality of connectors includes a single first electrical connector and each of the apertures of the plurality of apertures includes a single second electrical connector.

[0013] Clause 6. The sensor assembly of any of clauses 1 to 5, wherein the at least one connector is press-fit into the at least one opening.

[0014] Section 7. The sensor assembly of any of sections 1 to 6, wherein the disposable label includes a plurality of first conductive pads electrically coupled to the electrical conductive traces, and the reusable housing includes a plurality of second conductive pads coupled to the processor and removably electrically coupled to the plurality of first conductive pads via a conductive adhesive applied to at least one of the plurality of first conductive pads and the plurality of second conductive pads.

[0015] Section 8. The sensor assembly of any of sections 1 to 7, wherein the disposable label includes an adhesive layer.

[0016] Section 9. The sensor assembly of any of sections 1 to 8, wherein the disposable label includes a battery.

[0017] Clause 10. The sensor assembly of any of clauses 1 to 9, wherein the reusable housing includes a battery.

[0018] Clause 11. The sensor assembly of any of clauses 1 to 10, wherein the disposable label includes a further electrically conductive trace, a first portion of the further electrically conductive trace configured to be altered in response to a second operation of the injection device that is different from the first operation of the injection device, and the processor is removably electrically coupled to the further electrically conductive trace.

[0019] Clause 12. The sensor assembly of any of clauses 1 to 11, wherein the first operation of the injection device includes removing a cap or cover of the injection device, and the second operation of the injection device includes activating a button of the injection device or deploying a needle shield of the injection device.

[0020] Clause 13. The sensor assembly of any of clauses 1 to 12, wherein the second portion of the electrically conductive trace is configured to be altered in response to a second operation of the injection device that is different from the first operation of the injection device.

[0021] Clause 14. The sensor assembly of any of clauses 1 to 13, wherein the first operation of the injection device includes removing a cap or cover of the injection device, and the second operation of the injection device includes activating a button of the injection device or deploying a needle shield of the injection device.

[0022] Clause 15. The sensor assembly of any of clauses 1-14, wherein the disposable label includes at least one sensor, the at least one sensor including at least one of an optical sensor, a temperature sensor, a force sensor, or any combination thereof, and the at least one sensor is electrically coupled to the electrically conductive trace.

[0023] Clause 16. The sensor assembly of any of clauses 1 to 15, wherein the reusable housing includes at least one sensor, the at least one sensor including at least one of a vibration sensor, an accelerometer, an optical sensor, a magnetic sensor, or any combination thereof.

[0024] Clause 17. The sensor assembly of any of clauses 1 to 16, wherein altering the first portion of the electrically conductive trace comprises cutting the first portion of the electrically conductive trace.

[0025] Section 18. A system comprising a sensor assembly according to any one of sections 1 to 17 and a container for accommodating the sensor assembly.

[0026] Clause 19. The system of clause 18, wherein the disposable label includes a further electrically conductive trace, a portion of the label including the further electrically conductive trace is affixed to the container, a first portion of the further electrically conductive trace is configured to be altered in response to removal of the sensor assembly from the container, and the processor is removably electrically coupled to the further electrically conductive trace.

[0027] Clause 20. The system of any of clauses 18 and 19, wherein the second portion of the electrically conductive trace is configured to change in response to removal of the sensor assembly from the container, and the portion of the disposable label is affixed to the container.

[0028] Section 21. A system comprising: an injection device; a sensor assembly including: a disposable label affixed to the injection device, the disposable label including an electrically conductive trace, wherein a first portion of the electrically conductive trace is configured to be altered in response to a first operation of the injection device; and a reusable housing removably coupled to the disposable label, the reusable housing including a processor removably electrically coupled to the electrically conductive trace, the processor configured to be activated in response to the alteration of the electrically conductive trace; and a wireless communication device configured to wirelessly communicate information related to the alteration of the electrically conductive trace to a computing device.

[0029] Clause 22. The system of clause 21, wherein the disposable label includes a plurality of first conductive pads electrically coupled to the electrical conductive traces, the reusable housing includes a plurality of spring contacts electrically coupled to the processor and removably electrically coupled to the plurality of first conductive pads, and the reusable housing includes a rigid deformable clip removably fastened onto an exterior surface of the injection device.

[0030] Clause 23. The system of either clause 21 or clause 22, wherein the disposable label includes at least one connector extending from the disposable label, the reusable housing includes at least one opening into which the at least one connector is received, and the at least one connector includes a plurality of first electrical connectors electrically coupled to the electrically conductive traces and removably electrically coupled to a plurality of second electrical connectors in the at least one opening, the plurality of second electrical connectors electrically coupled to the at least one processor.

[0031] Clause 24. The system of any of clauses 21 to 23, wherein the at least one connector includes a plurality of connectors, and the at least one opening includes a plurality of openings corresponding to the plurality of connectors.

[0032] Clause 25. The system of any of clauses 21-24, wherein each of the connectors of the plurality of connectors includes a single first electrical connector, and each of the apertures of the plurality of apertures includes a single second electrical connector.

[0033] Clause 26. The system of any of clauses 21 to 25, wherein the at least one connector is press-fit into the at least one aperture.

[0034] Clause 27. The system of any of clauses 21 to 26, wherein the disposable label includes a plurality of first conductive pads electrically coupled to the electrical conductive traces, and the reusable housing includes a plurality of second conductive pads coupled to the processor and removably electrically coupled to the plurality of first conductive pads via a conductive adhesive applied to at least one of the plurality of first conductive pads and the plurality of second conductive pads.

[0035] Clause 28. The system of any of clauses 21 to 27, wherein the disposable label includes an adhesive layer.

[0036] Clause 29. The system of any of clauses 21 to 28, wherein the disposable label includes a battery.

[0037] Clause 30. The system of any of clauses 21 to 29, wherein the reusable housing includes a battery.

[0038] Clause 31. The system of any of clauses 21 to 30, wherein the disposable label includes a further electrically conductive trace, a first portion of the further electrically conductive trace configured to be altered in response to a second operation of the injection device that is different from the first operation of the injection device, and wherein the processor is removably electrically coupled to the further electrically conductive trace.

[0039] Clause 32. The system of any of clauses 21 to 31, wherein the first operation of the injection device includes removing a cap or cover of the injection device, and the second operation of the injection device includes activating a button of the injection device or deploying a needle shield of the injection device.

[0040] Clause 33. The system of any of clauses 21 to 32, wherein the second portion of the electrically conductive trace is configured to be altered in response to a second operation of the injection device that is different from the first operation of the injection device.

[0041] Clause 34. The system of any of clauses 21 to 33, wherein the first operation of the injection device includes removing a cap or cover of the injection device, and the second operation of the injection device includes activating a button of the injection device or deploying a needle shield of the injection device.

[0042] Clause 35. The system of any of clauses 21 to 34, wherein the disposable label includes at least one sensor, the at least one sensor including at least one of an optical sensor, a temperature sensor, a force sensor, or any combination thereof, and the at least one sensor is electrically coupled to the electrically conductive traces.

[0043] Clause 36. The system of any of clauses 21 to 35, wherein the reusable housing includes at least one sensor, the at least one sensor including at least one of a vibration sensor, an accelerometer, an optical sensor, a magnetic sensor, or any combination thereof.

[0044] Clause 37. The system of any of clauses 21 to 36, wherein altering the first portion of the electrically conductive trace comprises cutting the first portion of the electrically conductive trace.

[0045] Clause 38. The system of any of clauses 21 to 37, further comprising a container housing the sensor assembly and the injection device.

[0046] Clause 39. The system of any of clauses 21 to 38, wherein the disposable label includes a further electrically conductive trace, a portion of the label including the further electrically conductive trace is affixed to the container, a first portion of the further electrically conductive trace is configured to be altered in response to removal of the sensor assembly from the container, and the processor is removably electrically coupled to the further electrically conductive trace.

[0047] Clause 40. The system of any of clauses 21 to 39, wherein a second portion of the electrically conductive trace is configured to change in response to removal of the sensor assembly from the container, and a portion of the disposable label is affixed to the container.

[0048] These and other features of the present disclosure, as well as the method of operation and function of related elements of structure and economy of combination of parts and manufacture, will become more apparent from a consideration of the following description and the appended claims, with reference to the accompanying drawings, all of which form a part of this specification, in which like reference numerals indicate corresponding parts in the various views. It is to be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended as a definition of limitations. As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. [Brief explanation of the drawings]

[0049] Further advantages and details of embodiments or aspects of the present disclosure are explained in greater detail below with reference to exemplary embodiments illustrated in the accompanying schematic drawings.

[0050] [Figure 1] FIG. 1 is a diagram of a non-limiting embodiment or aspect of an environment in which the systems, devices, products, apparatus, and / or methods described herein may be implemented. [Figure 2] FIG. 2 is a perspective view of a non-limiting embodiment or aspect of a component of the sensor assembly of FIG. 1. [Figure 3A] 2 is a perspective view of a non-limiting embodiment or aspect of one or more devices and / or components of one or more systems of FIG. 1. [Figure 3B] 2 is a perspective view of a non-limiting embodiment or aspect of one or more devices and / or components of one or more systems of FIG. 1. [Figure 4A] 2 is a perspective view of a non-limiting embodiment or aspect of one or more devices and / or components of one or more systems of FIG. 1. [Figure 4B] 2 is a perspective view of a non-limiting embodiment or aspect of one or more devices and / or components of one or more systems of FIG. 1. [Figure 4C]2 is a perspective view of a non-limiting embodiment or aspect of one or more devices and / or components of one or more systems of FIG. 1. [Figure 5] 2A-2C are diagrams of non-limiting embodiments or aspects of components of the sensor assembly of FIG. 1. [Figure 6] 1 is a diagram of an implementation of a non-limiting embodiment or aspect of a sensor assembly. [Figure 7] FIG. 1 is a perspective view of an implementation of a non-limiting embodiment or aspect of a sensor assembly. [Figure 8] FIG. 1 is a perspective view of an implementation of a non-limiting embodiment or aspect of a sensor assembly. [Figure 9] FIG. 1 is a perspective view of an implementation of a non-limiting embodiment or aspect of a system including a sensor assembly. DETAILED DESCRIPTION OF THE INVENTION

[0051] It should be understood that the present disclosure may contemplate various alternative modifications and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are merely exemplary and non-limiting embodiments or aspects. Hence, specific dimensions and other physical characteristics related to the embodiments or aspects disclosed herein are not to be considered limiting.

[0052] For purposes of the following description, the terms "end," "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the present disclosure as oriented in the drawing figures. However, it should be understood that the present disclosure may contemplate various alternative modifications and step sequences, unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments or aspects of the present disclosure. Accordingly, specific dimensions and other physical characteristics related to the embodiments or aspects of embodiments disclosed herein are not to be considered limiting, unless otherwise indicated.

[0053] As used herein, no aspect, component, element, structure, act, step, function, instruction, and / or the like should be construed as critical or essential unless expressly described as such. Also, as used herein, the articles "a" and "an" are intended to include one or more items and may be used interchangeably with "one or more" and "at least one." Furthermore, as used herein, the term "set" is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" and "at least one." Where only one item is intended, the term "one" or similar language is used. Also, as used herein, the terms "has," "have," "having," and the like are intended to be open-ended terms. Furthermore, the phrase "based on" is intended to mean "based at least in part on," unless expressly stated otherwise.

[0054] As used herein, the terms “communication” and “communicate” refer to the receipt or transfer 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 the unit can receive data from and / or transmit data to the other unit, directly or indirectly. This may refer to a direct or indirect connection, wired and / or wireless in nature. Furthermore, two units may communicate with each other even if the transmitted data may be modified, processed, relayed, and / or forwarded between the first and second units. For example, a first unit may communicate with a second unit even if the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may communicate with a second unit if an intermediate unit processes data from the one unit and transmits the processed data to the second unit. It will be appreciated that many other configurations are possible.

[0055] It will be apparent that the systems and / or methods described herein can be implemented in different forms of hardware, software, or a combination of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods is not limiting of the implementation. Thus, the operation and behavior of the systems and / or methods are described herein without reference to specific software code, and it will be understood that software and hardware can be designed to implement the systems and / or methods based on the description herein.

[0056] Some non-limiting embodiments or aspects are described herein in relation to a threshold value. As used herein, meeting a threshold value may refer to a value being greater than the threshold value, more than the threshold value, higher than the threshold value, equal to or greater than the threshold value, less than the threshold value, less than the threshold value, lower than the threshold value, less than the threshold value, equal to the threshold value, etc.

[0057] As used herein, the terms "computing device" or "computer device" may refer to one or more electronic devices configured to communicate directly or indirectly with or via one or more networks. A computing device may be a mobile device, a desktop computer, or the like. Furthermore, the term "computer" may refer to any computing device that includes the components necessary to receive, process, and output data and typically includes a display, a processor, memory, input devices, and a network interface. An "application" or "application program interface (API)" refers to computer code or other data sorted on a computer-readable medium that can be executed by a processor to facilitate interaction between software components to receive data from a client, e.g., a client-side front-end and / or a server-side back-end. An "interface" refers to a generated display, e.g., one or more graphical user interfaces (GUIs), with which a user may interact either directly or indirectly (e.g., via a keyboard, mouse, touchscreen, etc.).

[0058] As used herein, the term "server" may refer to or include one or more processors, computers, storage devices, or similar computer configurations operated by or facilitating communication and processing for multiple parties in a network environment, such as the Internet, although it will be understood that communication may be facilitated through one or more public or private network environments, and various other configurations are possible. Furthermore, multiple computers, such as, for example, servers, or other computerized devices, such as POS devices, communicating directly or indirectly within a network environment may constitute a "system," such as, for example, a merchant's POS system. As used herein, the term "data center" may include one or more servers, other computing devices, and / or databases.

[0059] As used herein, the term "mobile device" may refer to one or more portable electronic devices configured to communicate with one or more networks. As an example, a mobile device may include a mobile phone (e.g., a smartphone or a standard mobile phone), a portable computer (e.g., a tablet computer, a laptop computer, etc.), a wearable device (e.g., a watch, eyeglasses, lenses, clothing, and / or the like), a personal digital assistant (PDA), and / or other similar devices. As used herein, the terms "client device" and "user device" refer to any electronic device configured to communicate with one or more servers or remote devices and / or systems. A client device or user device may include a mobile device, a network-enabled appliance (e.g., a network-enabled television, refrigerator, thermostat, and / or the like), a computer, and / or any other device or system capable of communicating with a network.

[0060] As used herein, the term "application" or "application program interface" (API) refers to computer code, a set of rules, or other data sorted on a computer-readable medium that can be executed by a processor to facilitate interaction between software components to receive data from a client, e.g., a client-side front-end and / or a server-side back-end. "Interface" refers to a generated display, e.g., one or more graphical user interfaces (GUIs), with which a user may interact either directly or indirectly (e.g., via a keyboard, mouse, etc.).

[0061] Referring to FIG. 1 , a non-limiting embodiment or aspect of an environment 100 in which the systems, devices, products, apparatuses, and / or methods described herein may be implemented is shown. As shown in FIG. 1 , environment 100 may include an injection device 102, a sensor assembly 104, and / or a computing device 106. The number and arrangement of devices and systems shown in FIG. 1 are provided as an example. There may be additional, fewer, different, or differently arranged devices and / or systems compared to the devices and systems shown in FIG. 1 . Furthermore, two or more devices and / or systems shown in FIG. 1 may be implemented within a single device and / or system, or a single device and / or system shown in FIG. 1 may be implemented as multiple distributed devices and / or systems. Additionally or alternatively, a set of devices and / or systems (e.g., one or more devices or systems) of environment 100 may perform one or more functions described as being performed by another set of devices and / or systems of environment 100.

[0062] The injection device 102 can be configured to perform an injection action to administer a dose of medication to a user. The injection device 102 can include a needle- or needleless injection device. The injection device 102 can be a disposable injection device (e.g., a single-use injection device) or a reusable injection device. The injection device 102 can include an autoinjector, a pen-type injector, a wearable injector, and / or a passive needle guard. For example, the injection device 102 can include a BD Intevia™ autoinjector, a BD Libertas™ wearable autoinjector, a BD Sonic™ autoinjector, and / or a BD UltraSafe Plus™ passive needle guard for prefilled ISO-standard glass syringes. Further details regarding non-limiting embodiments or aspects of the injection device 102 are provided below with respect to FIGS. 3A, 3B, and 4A-4C.

[0063] 2 , the sensor assembly 104 may include a disposable label 130 configured to be affixed to the injection device 102 and / or a reusable housing 150 removably coupled to the disposable label 130. The disposable label 130 may include a flexible and / or tearable (or easily cut) substrate. For example, the disposable label 130 may be formed from paper, tamper-evident tape, one or more polymers (e.g., PET, etc.), a flexible printed circuit board (PCB), or any combination thereof. The disposable label 130 may include an electrically conductive trace 132 (e.g., circuitry, etc.). For example, the electrically conductive trace 132 may be on a surface of the disposable label 130 and / or may be located within the disposable label 130 (e.g., integrated, housed, not exposed, etc.). As an example, the electrically conductive traces 132 may include a conductive material applied to the disposable label 130 by at least one of a printing (e.g., inkjet printing, screen printing, etc.) process, a metal deposition and / or etching process, a flexographic printing process, or any combination thereof.

[0064] The portion 134 of the disposable label 130 may be configured to be altered (e.g., bent, torn, cut, etc.). Altering the portion 134 of the disposable label 130 may cause a corresponding portion of the electrically conductive trace 132 to be altered. For example, a first portion of the electrically conductive trace 132 may be configured to be altered in response to operation of the injection device 102. By way of example, the portion 134 of the disposable label 130 may be pre-cut, perforated, and / or the like, and tearing and / or cutting the portion 134 of the disposable label 130 may cause the corresponding portion of the electrically conductive trace 132 to be torn and / or cut, thereby changing the state of the circuit formed by the electrically conductive trace 132 (e.g., opening the circuit, closing the circuit, changing the resistance of the circuit, changing the voltage or current flowing through the circuit, etc.). In such an example, a first portion of the disposable label 130 including at least a portion of the electrically conductive traces 132 may be affixed to a removable and / or actuatable element (e.g., a cap, button, etc.) of the injection device 102, and the remainder of the disposable label 130 affixed to the first portion via portion 134 may be affixed elsewhere on the injection device 102, and removal and / or actuation of the removable and / or actuatable element (e.g., a cap, button, etc.) of the injection device 102 may cause portion 134 of the disposable label 130 to tear and / or cut, thereby causing the corresponding portion of the electrically conductive traces 132 to tear and / or cut, changing the state of the circuit formed by the electrically conductive traces 132.

[0065] 3A and 3B are perspective views of an implementation 300 of a non-limiting embodiment or aspect of a sensor assembly 104 for an injection device 102. As shown in FIG. 3A, a first portion of a disposable label 130 including at least a portion of an electrically conductive trace 132 may be affixed to the cap of the injection device 102, and the remainder of the disposable label 130 may be affixed to the body of the injection device 102. As shown in FIG. 3B, removal of the cap of the injection device 102 may cause a portion 134 of the disposable label 130 to tear and / or cut, thereby causing a corresponding portion of the electrically conductive trace 132 to tear and / or cut, changing the state of the circuit formed by the electrically conductive trace 132.

[0066] 4A-4C are perspective views of an implementation 400 of a non-limiting embodiment or aspect of a sensor assembly 104 for an injection device 102. As shown in FIG. 4A, a first portion of a disposable label 130 including at least a portion of the electrically conductive traces 132 may be affixed to a button of the injection device 102, and the remainder of the disposable label 130 may be affixed to the body of the injection device 102. As shown in FIG. 4B, actuation of the button of the injection device 102 may cause a portion 134 of the disposable label 130 to tear and / or cut, thereby causing a corresponding portion of the electrically conductive traces 132 to tear and / or cut, changing the state of the circuit formed by the electrically conductive traces 132. FIG. 4C illustrates an alternative position of the sensor assembly 104 in which a first portion of the disposable label 130 including at least a portion of the electrically conductive traces 132 may be affixed to the cover of the injection device 102, and the remainder of the disposable label 130 may be affixed to the body of the injection device 102. Removal of the cover of the injection device 102 may cause a portion 134 of the disposable label 130 to tear and / or cut, thereby causing a corresponding portion of the electrically conductive trace 132 to tear and / or cut, changing the state of the circuit formed by the electrically conductive trace 132.

[0067] In some non-limiting embodiments or aspects, the disposable label 130 includes an adhesive layer 136. For example, the adhesive layer 136 may adhere the disposable label 130 to packing and / or a container for the injection device 102 and / or the sensor assembly 104. By way of example, as shown in FIG. 2 , the electrically conductive traces 132 may be on a first side of the disposable label 130 (e.g., the same side of the disposable label 130 to which the reusable housing 150 is affixed), and the adhesive layer 136 may be on a second side of the disposable label 130 that is opposite the first side of the disposable label 130.

[0068] In some non-limiting embodiments or aspects, the disposable label 130 includes a sensor 137. For example, the sensor 137 may include at least one of an optical sensor (e.g., a printed photodetector, etc.), a temperature sensor, a force sensor (e.g., a force resistance sensor, a membrane switch, etc.), or any combination thereof. As an example, the sensor 137 may be electrically coupled to the electrically conductive traces 132. In some non-limiting embodiments or aspects, the sensor 137 may be used in place of or in addition to the portion 134 to detect the removal and / or actuation of a removable and / or actuatable element (e.g., a cap, a button, etc.) of the injection device 102. For example, a photodetector may be used to sense ambient light when a cap of the injection device 102 is removed, and a temperature or force sensor may be used to sense a temperature change or force applied to a surface when a user actuates a button and / or the like of the injection device 102 (e.g., using a force resistance sensor printed on the label 130, a membrane switch on the label 130, etc.).

[0069] In some non-limiting embodiments or aspects, the disposable label 130 includes a battery 138 and / or a memory 139. For example, the battery 138 and / or the memory 139 may be connected to the electrically conductive traces 132. The battery 138 may provide power to components of the reusable housing 150 when the reusable housing 150 is affixed to the disposable label 130 (e.g., upon alteration of the electrically conductive traces 132, etc.). The battery 138 may include a flexible battery, a thin-film battery, a printed battery, or any combination thereof. The memory 139 may store a unique identifier associated with the disposable label 130 and / or the injection device 102. For example, the unique identifier may be accessed by and / or provided to components of the reusable housing 150 (e.g., a processor, etc.) when the reusable housing 150 is affixed to the disposable label 130 (e.g., upon alteration of the electrically conductive traces 132, etc.).

[0070] The reusable housing 150 may include (e.g., carry, house, encompass, etc.) a processor 152 and / or a wireless communication device 154. The processor 152 may be removably electrically coupled to the electrically conductive traces 132. In some non-limiting embodiments or aspects, the processor 152 may be configured to be activated in response to a change in a portion of the electrically conductive traces 132 (e.g., in response to opening a circuit, closing a circuit, changing the resistance of the circuit, changing the voltage or current flowing through the circuit, etc.). For example, a change in the electrically conductive traces 132 may wake the processor 152 from a deep sleep mode. As an example, the circuit formed by the electrically conductive traces 132 may be initially intact and operate as a closed switch, and when a user activates or operates the injection device 102 and tears the disposable label 130, the electrically conductive traces 132 may be disconnected and operate as an open switch. However, non-limiting embodiments or aspects are not so limited, and the circuit formed by the electrically conductive traces 132 may have, as an initial state, a closed circuit, an initial resistance, an initial voltage, an initial current, or any combination thereof, and after modification, the circuit formed by the electrically conductive traces 132 may have, as a different state, an open circuit, a second resistance, a second voltage, a second current, or any combination thereof. In some non-limiting embodiments or aspects, the processor 152 and the wireless communication device 154 are implemented in a single system-on-chip component.

[0071] The wireless communication device 154 may be configured to communicate wirelessly with the computing device 106. For example, the wireless communication device 154 may be configured to communicate information associated with the use and / or operation of the injection device 102 to the computing device 106 (e.g., information associated with changes in the electrically conductive traces 132, sensor data, unique identifiers, etc.). In some non-limiting embodiments or aspects, the wireless communication device 154 includes one or more computing devices, chips, contactless transmitters, contactless transceivers, NFC transmitters, RFID transmitters, contact-based transmitters, Bluetooth transceivers, and / or the like that enable the wireless communication device 154 to receive information directly from and / or communicate information directly to the computing device 106 via a short-range wireless communication connection (e.g., a communication connection using an NFC protocol, a communication connection using radio frequency identification (RFID), a communication connection using the Bluetooth wireless technology standard, a communication protocol using the Zigbee wireless technology standard, a communication protocol using the Ant wireless technology standard, and / or the like).

[0072] Now referring to FIG. 5, in some non-limiting embodiments or aspects, the reusable housing 150 includes (e.g., carries, houses, encompasses, etc.) a sensor 155, a user feedback device 156, an RTC 157, a power source 158, and / or a memory 159.

[0073] The sensor 155 may include at least one of a vibration sensor, an accelerometer, an optical sensor, a magnetic sensor, or any combination thereof. In some non-limiting embodiments or aspects, the sensor 155 is configured to detect movement of a component of the injection device 102 associated with an injection operation of the injection device 102. For example, the sensor 155 may be configured to detect movement (e.g., movement, displacement, etc.) of at least one of a piston, a plunger stopper, a plunger rod, and a movable trigger that initiates or causes movement of the plunger.

[0074] Processor 152 may be programmed and / or configured to determine, based on the state of electrically conductive trace 132, the signal or sensor data received from sensor 137, and / or the signal or sensor data received from sensor 155, information associated with the use and / or operation of injection device 102. In some non-limiting embodiments or aspects, the information associated with the use and / or operation of injection device 102 includes at least one of: a time of removal of the cap of injection device 102, a time of removal of the cover of injection device 102, a time of actuation of the button of injection device 102, a start time of the injection operation, a duration of the injection operation, a speed of the injection operation, a backpressure profile of the injection operation, or any combination thereof. Processor 152 may store information associated with the use and / or operation of injection device 102 in memory 159.

[0075] The user feedback device 156 may be configured to provide the user with an indication associated with the injection operation and / or information related to the use and / or operation of the injection device 102. For example, the user feedback device 156 may include at least one of a display, a light emitting diode (LED), an audio output device (e.g., a buzzer, a speaker, etc.), or any combination thereof.

[0076] The RTC 157 may include a computer clock (e.g., in the form of an integrated circuit) that records the current time. For example, the processor 152 may receive timestamp information associated with the use and / or operation of the injection device 102 based on the current time of the RTC 157 (e.g., time of cap removal, time of button actuation, etc.).

[0077] The power source 158 may be configured to provide power to the processor 152, the wireless communication device 154, the sensor 155, the user feedback device 156, the RTC 157, and / or the memory 159. For example, the power source 158 may include a battery (e.g., a rechargeable battery, a disposable battery, etc.).

[0078] The memory 159 may be configured to store information related to the use and / or operation of the injection device 102. In some non-limiting embodiments or aspects, the memory 159 stores a unique identifier associated with the reusable housing 150 and / or the injection device 102. For example, the unique identifier may be accessed by and / or provided to the processor 152 in response to changes in the electrically conductive traces 132.

[0079] 5 and again to FIG. 1, computing device 106 may include one or more devices capable of receiving information and / or data from sensor assembly 104 and / or communicating information and / or data to sensor assembly 104. For example, computing device 106 may include a computing device, a server, a group of servers, a mobile device, a group of mobile devices, and / or the like. In some non-limiting embodiments or aspects, the computing device 106 includes one or more computing devices, chips, contactless transmitters, contactless transceivers, NFC transmitters, RFID transmitters, contact-based transmitters, and / or the like that enable the computing device 106 to receive information directly from and / or communicate information directly to the wireless communication device 154 via a short-range wireless communication connection (e.g., a communication connection using an NFC protocol, a communication connection using radio frequency identification (RFID), a communication connection using the Bluetooth® wireless technology standard, a communication protocol using the Zigbee wireless technology standard, a communication protocol using the Ant wireless technology standard, and / or the like). In some non-limiting embodiments or aspects, the computing device 106 may include and / or upload information and / or data to an electronic data management system, such as, for example, a hospital records system, a system used during a clinical trial to collect trial-related information, and / or the like.

[0080] Reference is now made to FIG. 6 , which is a diagram of an implementation 600 of a non-limiting embodiment or aspect of the sensor assembly 104. As shown in FIG. 6 , the disposable label 130 may include an additional electrically conductive trace 133, and the processor 152 may be removably electrically coupled to the additional electrically conductive trace. In some non-limiting embodiments or aspects, the additional electrically conductive trace may be the same as or similar to the electrically conductive trace 132, except that a second portion of the disposable label 130 including at least a portion of the additional electrically conductive trace 133 may be affixed to a different removable and / or actuatable element (e.g., cap, button, etc.) of the injection device 102 than the first portion of the disposable label 130 including at least a portion of the electrically conductive trace 132. As an example, the portion 135 of the additional electrically conductive trace 133 may be configured to change in response to a second operation of the injection device 102 that is different from a first operation of the injection device 102 corresponding to the change in portion 134 of the electrical conductive trace 132. As an example, the first operation of the injection device 102 may include removing a cap or cover of the injection device 102, and the second operation of the injection device 102 may include activating a button on the injection device 102 or deploying a needle shield on the injection device 102.

[0081] 6 , in some non-limiting embodiments or aspects, a second portion of the electrically conductive traces (e.g., the electrically conductive trace 132, the further electrically conductive trace 133, etc.) is configured to be altered in response to a second action of the injection device 102 that is different from a first action of the injection device responsive to the alteration of the first portion of the electrically conductive traces. For example, the disposable label 130 may include portions 135 a, 135 b, ... 135 n that are configured to be altered (e.g., bent, torn, cut, etc.) to cause a corresponding portion of the further electrically conductive trace 133 to be altered, thereby changing the state of the circuit formed by the further electrically conductive trace 133 (e.g., open the circuit, close the circuit, change the resistance of the circuit, change the voltage or current flowing through the circuit, etc.). As an example, the disposable label 130 may include multiple portions each including a first resistor R1, a second resistor R2, and a third resistor R3, each connected to the reusable housing 150 and connected to each other via portions 135a, 135b, and 135n, respectively.In such an example, a first portion of the disposable label 130 (e.g., including resistor Rn, etc.) including at least a portion of the further electrically conductive trace 133 may be affixed to a removable and / or actuatable element of the injection device 102 (e.g., a cap, a button, etc.), and another portion of the disposable label 130 (e.g., including resistor R2, etc.) that is affixed to the first portion via portion 135n may be affixed elsewhere on the injection device 102 (e.g., another removable and / or actuatable element of the injection device 102, etc.), and removal and / or actuation of the removable and / or actuatable element of the injection device 102 (e.g., a cap, a button, etc.) may activate the disposable label 130. The removal and / or actuation of another removable and / or actuatable element of the injection device 102 may cause the tearing and / or severing of portion 135n of the disposable label 130, thereby causing a corresponding portion of the further electrically conductive trace 133 to tear and / or cut, changing the state of the circuit formed by the further electrically conductive trace 133, and the removal and / or actuation of another removable and / or actuatable element of the injection device 102 may cause the tearing and / or severing of portion 135b of the disposable label 130, thereby causing a corresponding portion of the further electrically conductive trace 133 to tear and / or cut, changing the state of the circuit formed by the further electrically conductive trace 133. For example, a first actuation of the injection device 102 may include the removal of a cap or cover of the injection device 102, and a second actuation of the injection device 102 may include the actuation of a button on the injection device 102 or the deployment of a needle shield on the injection device 102.

[0082] In some non-limiting embodiments or aspects, a further portion of the disposable label 130 affixed to another portion via portion 135b (e.g., including resistor R1, etc.) may be affixed elsewhere on the injection device 102 (e.g., to a further removable and / or actuatable element of the injection device 102, etc.), and removal and / or actuation of the further removable and / or actuatable element of the injection device 102 may cause the portion 135a of the disposable label 130 to be torn and / or cut, thereby causing a corresponding portion of the further electrically conductive trace 133 to be torn and / or cut, changing the state of the circuit formed by the further electrically conductive trace 133. By way of example, the change caused in the state of the circuit may be different in response to the tearing and / or cutting of each of portions 135a, 135b, ... 135n (e.g., the change opens the circuit, closes the circuit, changes the resistance of the circuit, changes the voltage or current flowing through the circuit, etc.).

[0083] Reference is now made to FIG. 7 , which is a diagram of an implementation 700 of a non-limiting embodiment or aspect of the sensor assembly 104. As shown in FIG. 7 , the disposable label 130 may include a plurality of first conductive pads 702 electrically coupled to the electrically conductive traces 132 (and / or the additional electrically conductive traces 133), and the reusable housing 150 may include a plurality of spring contacts 704 electrically coupled to the processor 152 and removably electrically coupled to the plurality of first conductive pads 702. The reusable housing 150 may include a rigid deformable clip 706 configured to clip onto an outer surface of the injection device 102. For example, the rigid deformable clip 706 may include a half-pipe shape, and when the clip 706 is pressed onto the injection device 102 and contacts the plurality of first conductive pads 702 with the plurality of spring contacts 704, the material forming the half-pipe shape is configured to deform around and grip the outer surface of the injection device 102. The reusable housing 150 may be attached to and / or integrated with the rigid deformable clip 706. For example, the reusable housing 150 may be attached to the rigid deformable clip 706 via a clip, a snap fit, an adhesive, and / or other mechanical interface. The rigid deformable clip 706 may be configured and / or dimensioned according to the type (e.g., size, model, etc.) of the injection device 102.

[0084] In some non-limiting embodiments or aspects, the disposable label 130 includes a plurality of first conductive pads electrically coupled to the electrical conductive traces 132 (and / or the additional electrical conductive traces 133), and the reusable housing 150 is coupled to the processor 152 and includes a plurality of second conductive pads removably electrically coupled to the plurality of first conductive pads via a conductive adhesive applied to at least one of the plurality of first conductive pads and the plurality of second conductive pads. For example, instead of or in addition to the rigidly deformable clip 706 and spring contacts 704 shown in FIG. 7 , the disposable label 130, the reusable housing 150, the plurality of first conductive pads, and / or the plurality of second conductive pads may include an adhesive layer (and / or the disposable label 130 in contact with the reusable housing 150) configured to maintain contact between the plurality of first conductive pads and the plurality of second conductive pads.

[0085] Reference is now made to FIG. 8 , which is a diagram of an implementation 800 of a non-limiting embodiment or aspect of the sensor assembly 104. As shown in FIG. 8 , the disposable label 130 may include at least one connector 802 extending from the disposable label 130, the reusable housing 150 may include at least one opening 804 into which the at least one connector 802 is received, and the at least one connector 802 may include a plurality of first electrical connectors (e.g., wires, pins, etc.) electrically coupled to the electrically conductive traces 132 (and / or the additional electrically conductive traces 133) and removably electrically coupled to a plurality of second electrical connectors (e.g., wires, pins, etc.) in the at least one opening 804, the plurality of second electrical connectors being electrically coupled to the processor 152. In some non-limiting embodiments or aspects, the at least one connector 802 is press-fit into the at least one opening 804.

[0086] In some non-limiting embodiments or aspects, the at least one connector 802 includes a plurality of connectors 802, and the at least one aperture 804 includes a plurality of apertures 804 corresponding to the plurality of connectors 802. In some non-limiting embodiments or aspects, each of the connectors of the plurality of connectors includes a single first electrical connector (e.g., a single wire, a single pin, etc.), and each of the apertures of the plurality of apertures includes a single second electrical connector (e.g., a single wire, a single pin, etc.).

[0087] Reference is now made to FIG. 9 , which is a diagram of an implementation 900 of a non-limiting embodiment or aspect of a system including a sensor assembly 104. As shown in FIG. 9 , a system according to a non-limiting embodiment or aspect may include an injection device 102, a sensor assembly 104, and / or a container 902. The disposable label 130 of the sensor assembly 104 may include electrical conductive traces (e.g., electrical conductive trace 132, additional electrical conductive trace 133, etc.) with a portion of the disposable label 130 including the electrical conductive trace attached to the container 902. For example, a portion of the electrical conductive traces (e.g., portion 134, portions 135a, 135b, ... 135n, etc.) may be configured to change upon removal of the sensor assembly 104 from the container 902. As an example, a reusable housing 150 may be reused with multiple disposable labels 130 and / or injection devices 102. For example, the container 902 may contain multiple disposable labels 130 and / or injection devices 102 and reusable housings 150, and the reusable housings 150 may be attached to a different disposable label 130 / injection device 102 each time a new disposable label 130 / injection device 102 is removed from the container 902. Thus, costs may be lower than disposing of the entire module for each injection device, the pairing process between the module and the computing device 106 may only be performed once, if at all, the user may be required to return only the reusable housing (avoiding manipulation of sharps) to a physician (or investigator in the case of a clinical trial) for calibration or adherence purposes, and any applicable recycling processes requiring disassembly of electronic components may be mitigated.

[0088] While embodiments or aspects have been described in detail for purposes of illustration and description, it should be understood that such detail is for that purpose only, and that the embodiments or aspects are not limited to the disclosed embodiments or aspects, but rather are 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 or aspect can be combined with one or more features of any other embodiment or aspect. Indeed, any of these features may be combined in ways not specifically recited in the claims and / or specifically disclosed herein. While each dependent claim listed below may depend directly on only one claim, the disclosure of possible implementations includes each dependent claim in combination with all other claims in the claim set.

Claims

1. A sensor assembly (104) for an injection device (102), comprising: A disposable label (130) attached to the injection device (102), an electrically conductive trace (132), wherein a first portion of the electrically conductive trace (132) is configured to be altered in response to a first operation of the injection device (102); a disposable label (130) including: a reusable housing (150) removably connected to the disposable label (130), a processor (152) removably electrically coupled to the electrically conductive traces (132), the processor (152) configured to be activated in response to a change in the electrically conductive traces (132); a wireless communication device (154) configured to wirelessly communicate information related to the alteration of the electrically conductive trace (132) to a computing device; a reusable housing (150) comprising: Equipped with The disposable label (130) includes at least one connector (802) extending from the disposable label (130), the reusable housing (150) includes at least one opening (804) into which the at least one connector (802) is received, and the at least one connector (802) includes a plurality of first electrical connectors electrically coupled to the electrically conductive traces (132) and removably electrically coupled to a plurality of second electrical connectors in the at least one opening (804), the plurality of second electrical connectors being electrically coupled to the processor (152).

2. the at least one connector (802) includes a plurality of connectors, and the at least one opening (804) includes a plurality of openings corresponding to the plurality of connectors; 2. The sensor assembly (104) of claim 1, wherein each of the connectors of the plurality of connectors includes a single first electrical connector, and each of the apertures of the plurality of apertures includes a single second electrical connector.

3. The sensor assembly (104) of claim 1, wherein the at least one connector (802) is press-fit into the at least one opening (804).

4. the disposable label includes a further electrically conductive trace (133), a first portion of the further electrically conductive trace (133) configured to be changed in response to a second operation of the injection device (102) that is different from the first operation of the injection device (102); the processor (152) is removably electrically coupled to the further electrically conductive traces (133); 2. The sensor assembly (104) of claim 1, wherein the first operation of the injection device (102) includes removing a cap or cover of the injection device (102), and the second operation of the injection device (102) includes activating a button on the injection device (102) or deploying a needle shield on the injection device (102).

5. a second portion of the electrically conductive trace (132) configured to be altered in response to a second operation of the injection device (102) that is different from the first operation of the injection device (102); 2. The sensor assembly (104) of claim 1, wherein the first operation of the injection device (102) includes removing a cap or cover of the injection device (102), and the second operation of the injection device (102) includes activating a button on the injection device (102) or deploying a needle shield on the injection device (102).

6. 2. The sensor assembly (104) of claim 1, wherein the disposable label (130) includes at least one sensor (137), the at least one sensor (137) including at least one of an optical sensor, a temperature sensor, a force sensor, or any combination thereof, and the at least one sensor (137) is electrically coupled to the electrically conductive trace (132).

7. 10. The sensor assembly of claim 1, wherein the reusable housing includes at least one sensor, the at least one sensor including at least one of a vibration sensor, an accelerometer, an optical sensor, a magnetic sensor, or any combination thereof.

8. The sensor assembly (104) of claim 1, wherein the alteration of the first portion of the electrically conductive trace (132) comprises a cut in the first portion of the electrically conductive trace (132).

9. The sensor assembly of claim 1; a container (902) for housing the sensor assembly; A system comprising:

10. 2. The sensor assembly (104) of claim 1, wherein the disposable label (130) includes a further electrically conductive trace (133), a portion of the disposable label (130) including the further electrically conductive trace (133) is affixed to a container (902), a first portion of the further electrically conductive trace (133) is configured to be altered in response to removal of the sensor assembly (104) from the container (902), and the processor (152) is removably electrically coupled to the further electrically conductive trace (133).

11. 2. The sensor assembly (104) of claim 1, wherein a second portion of the electrically conductive trace (132) is configured to be altered in response to removal of the sensor assembly (104) from a container (902), and a portion of the disposable label (130) is affixed to the container (902).

12. The sensor assembly (104) of claim 1; The injection device (102) of claim 1; A system comprising:

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