This present application claims priority to European Patent Application No. 20305683.3 filed Jun. 22, 2020, the entire disclosure of which is hereby incorporated by reference in its entirety.
The present disclosure relates generally to a sensor assembly and, in some non-limiting embodiments or aspects, a sensory assembly for attachment to an injection device and configured for wireless communication.
A wide variety of injection devices for fluid injections are currently commercially available. However, many of these devices do not provide any mechanism to capture and/or transfer drug injection related data.
Accordingly, provided are improved systems, devices, products, apparatus, and/or methods for identifying devices connected to device connectors.
According to some non-limiting embodiments or aspects, provided is a sensor assembly for an injection device including: a housing including: a sensor configured to detect a movement of a component of the injection device associated with an injection operation of the injection device; and a wireless communication device configured to communicate, to a computing device, information associated with the movement of the component of the injection device; and a mechanical interface configured to attach the housing to an exterior surface of the injection device.
According to some non-limiting embodiments or aspects, provided is a system including: an injection device and a sensor assembly including: a housing including: a sensor configured to detect a movement of a component of the injection device associated with an injection operation of the injection device; and a wireless communication device configured to communicate, to a computing device, information associated with the movement of the component of the injection device; and a mechanical interface configured to attach the housing to an exterior surface of the injection device.
Further embodiments or aspects are set forth in the following numbered clauses:
Clause 1. A sensor assembly for an injection device comprising: a housing including: a sensor configured to detect a movement of a component of the injection device associated with an injection operation of the injection device; and a wireless communication device configured to communicate, to a computing device, information associated with the movement of the component of the injection device; and a mechanical interface configured to attach the housing to an exterior surface of the injection device.
Clause 2. The sensor assembly of clause 1, wherein the component of the injection device includes at least one of the following: a stopper of a plunger, a rod of the plunger, a mobile trigger that triggers the movement of the plunger, a mobile component of the injection device that triggers the injection operation, a needle shield, or any combination thereof, and wherein the sensor is configured to detect the movement of the at least one of the stopper of the plunger, the rod of the plunger, the mobile trigger, the mobile component of the injection device that triggers the injection operation, the needle shield, or any combination thereof.
Clause 3. The sensor assembly of any of clauses 1 and 2, wherein the information associated with the movement of the component of the injection device includes at least one of the following: a start time of the injection operation, a duration of the injection operation, an end time of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, a time of a needle shield deployment, a measured internal noise or vibration of the injection device (e.g., an acoustic and/or vibration profile, etc.), a measured injection force (e.g., a spring force, etc.), or any combination thereof.
Clause 4. The sensor assembly of any of clauses 1-3, wherein the housing includes one or more processors programmed and/or configured to determine, based on sensor data received from the sensor, the information associated with the movement of the component of the injection device.
Clause 5. The sensor assembly of any of clauses 1-4, wherein the housing includes a user feedback device, and wherein the user feedback device includes at least one of the following: a display, a light-emitting diode (LED), an audio output device, or any combination thereof.
Clause 6.The sensor assembly of any of clauses 1-5, wherein the housing includes a battery configured to power the sensor.
Clause 7. The sensor assembly of any of clauses 1-6, wherein the wireless communication device includes a short range wireless communication device.
Clause 8. The sensor assembly of any of clauses 1-7, wherein the housing includes a memory.
Clause 9. The sensor assembly of any of clauses 1-8, wherein the injection device includes one of the following: an auto injector, a pen injector, a wearable injector, a safety syringe device, a pre-filled syringe, and a passive needle guard.
Clause 10. The sensor assembly of any of clauses 1-9, wherein the mechanical interface is configured to index a position of the sensor relative to a drug inspection window of the injection device, and wherein the sensor is calibrated according to the indexed position of the sensor relative to the drug inspection window of the injection device.
Clause 11. The sensor assembly of any of clauses 1-10, wherein the housing is removably attached to the mechanical interface.
Clause 12. The sensor assembly of any of clauses 1-11, wherein the housing is integrated with the mechanical interface.
Clause 13. The sensor assembly of any of clauses 1-12, wherein the mechanical interface includes a base plate configured to be attached to the exterior surface of the injection device.
Clause 14. The sensor assembly of any of clauses 1-13, wherein the mechanical interface includes the exterior surface of the injection device.
Clause 15. The sensor assembly of any of clauses 1-14, wherein the mechanical interface includes an adhesive.
Clause 16. The sensor assembly of any of clauses 1-15, wherein the mechanical interface includes an adhesive label.
Clause 17. The sensor assembly of any of clauses 1-16, wherein the mechanical interface includes a ring or sleeve configured to fit around the exterior surface of the injection device, and wherein the ring or sleeve includes at least one of an elastomeric material and a heat-shrinkable material.
Clause 18. The sensor assembly of any of clauses 1-17, wherein the mechanical interface includes a rigid deformable clip configured to clip onto the exterior surface of the injection device.
Clause 19. The sensor assembly of any of clauses 1-18, wherein the sensor includes an optical sensor.
Clause 20. The sensor assembly of any of clauses 1-19, wherein, when the housing is attached to the injection device via the mechanical interface, the optical sensor is positioned to detect the movement of the component of the injection device through a drug inspection window of the injection device.
Clause 21. The sensor assembly of any of clauses 1-20, wherein the optical sensor includes an array of photodetector and LED pairs.
Clause 22. The sensor assembly of any of clauses 1-21, wherein the optical sensor includes a single photodetector and LED pair, and wherein the component of the injection device includes a printed or gradated pattern visible through the drug inspection window of the injection device.
Clause 23. The sensor assembly of any of clauses 1-22, wherein, when the housing is attached to the injection device via the mechanical interface, the housing partially overlaps a drug inspection window of the injection device.
Clause 24. The sensor assembly of any of clauses 1-23, wherein the injection device includes a plurality of drug inspection windows, and wherein, when the housing is attached to the injection device via the mechanical interface, the housing fully overlaps one of the plurality of drug inspection windows.
Clause 25. The sensor assembly of any of clauses 1-24, wherein the sensor includes an acoustic or vibration sensor.
Clause 26. The sensor assembly of any of clauses 1-25, wherein, when the housing is attached to the injection device via the mechanical interface, the acoustic or vibration sensor is positioned to measure an internal noise or vibration of the injection device to detect the movement of the component of the injection device.
Clause 27. The sensor assembly of any of clauses 1-26, further comprising: one or more processors programmed and/or configured to compare a signal received from the acoustic sensor or the vibration sensor to one or more reference signals to determine at least one of the following: a start time of the injection operation, a duration of the injection operation, an end time of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, a time of a needle shield deployment, a measured internal noise or vibration of the injection device, a measured injection force, or any combination thereof.
Clause 28. The sensor assembly of any of clauses 1-27, wherein the sensor includes a magnetic sensor.
Clause 29. The sensor assembly of any of clauses 1-28, wherein the component of the injection device includes a magnet, and wherein, when the housing is attached to the injection device via the mechanical interface, the magnetic sensor is positioned to measure a magnetic field modification and/or a magnetic evolution created by the magnet to detect the movement of the component of the injection device.
Clause 30. The sensor assembly of any of clauses 1-29, wherein, when the housing is attached to the injection device via the mechanical interface, the magnetic sensor is positioned at a center of a range of motion of the magnet.
Clause 31. The sensor assembly of any of clauses 1-30, wherein the magnet includes a printed or gradated magnetic pattern or scale.
Clause 32. A system comprising: an injection device; and the sensor assembly according to any of clauses 1-31.
These and other features and characteristics of the present disclosure, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of limits. As used in the specification and the claims, the singular form of “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
Additional advantages and details of embodiments or aspects of the present disclosure are explained in greater detail below with reference to the exemplary embodiments that are illustrated in the accompanying schematic figures, in which:
It is to be understood that the present disclosure may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply 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 as limiting.
For purposes of the description hereinafter, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and derivatives thereof shall relate to the present disclosure as it is oriented in the drawing figures. However, it is to be understood that the present disclosure may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments or aspects of the present disclosure. Hence, specific dimensions and other physical characteristics related to the embodiments or aspects of the embodiments disclosed herein are not to be considered as limiting unless otherwise indicated.
No aspect, component, element, structure, act, step, function, instruction, and/or the like used herein should be construed as critical or essential unless explicitly 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, a combination of related and unrelated items, etc.) and may be used interchangeably with “one or more” or “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,” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based at least in partially on” unless explicitly stated otherwise.
As used herein, the terms “communication” and “communicate” refer to the receipt or transfer of one or more signals, messages, commands, or other type of data. For one unit (e.g., any device, system, or component thereof) to be in communication with another unit means that the one unit is able to directly or indirectly receive data from and/or transmit data to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature. Additionally, two units may be in communication with each other even though the data transmitted may be modified, processed, relayed, and/or routed between the first and second unit. For example, a first unit may be in communication with a second unit even though the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may be in communication with a second unit if an intermediary unit processes data from one unit and transmits processed data to the second unit. It will be appreciated that numerous other arrangements are possible.
It will be apparent that systems and/or methods, described herein, can be implemented in different forms of hardware, software, or a combination of hardware and software. The actual specialized control hardware or software code used to implement these systems and/or methods is not limiting of the implementations. Thus, the operation and behavior of the systems and/or methods are described herein without reference to specific software code, it being understood that software and hardware can be designed to implement the systems and/or methods based on the description herein.
Some non-limiting embodiments or aspects are described herein in connection with thresholds. As used herein, satisfying a threshold may refer to a value being greater than the threshold, more than the threshold, higher than the threshold, greater than or equal to the threshold, less than the threshold, fewer than the threshold, lower than the threshold, less than or equal to the threshold, equal to the threshold, etc.
As used herein, the term “computing device” or “computer device” may refer to one or more electronic devices that are configured to directly or indirectly communicate with or over one or more networks. The 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 necessary components to receive, process, and output data, and normally includes a display, a processor, a memory, an input device, 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 may be executed by a processor to facilitate the interaction between software components, such as a client-side front-end and/or server-side back-end for receiving data from the client. An “interface” refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user may interact, either directly or indirectly (e.g., through a keyboard, mouse, touchscreen, etc.).
As used herein, the term “server” may refer to or include one or more processors or computers, storage devices, or similar computer arrangements that are operated by or facilitate communication and processing for multiple parties in a network environment, such as the Internet, although it will be appreciated that communication may be facilitated over one or more public or private network environments and that various other arrangements are possible. Further, multiple computers, e.g., servers, or other computerized devices, such as POS devices, directly or indirectly communicating in the network environment may constitute a “system,” such as a merchant’s POS system. As used herein, the term “data center” may include one or more servers, or other computing devices, and/or databases.
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 cellular phone (e.g., a smartphone or standard cellular phone), a portable computer (e.g., a tablet computer, a laptop computer, etc.), a wearable device (e.g., a watch, pair of glasses, lens, clothing, and/or the like), a personal digital assistant (PDA), and/or other like devices. The terms “client device” and “user device,” as used herein, refer to any electronic device that is 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.
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 may be executed by a processor to facilitate interaction between software components, such as a client-side front-end and/or server-side back-end for receiving data from the client. An “interface” refers to a generated display, such as one or more graphical user interfaces (GUIs) with which a user may interact, either directly or indirectly (e.g., through a keyboard, mouse, etc.).
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Injection device 102 may be configured to perform an injection operation to deliver a dose of medicament to a user. Injection device 102 may include injection devices with or without injection needles. Injection device 102 may be a disposable type injection device (e.g., a single use injection device, etc.) or a re-usable type injection device. Injection device 102 may include an auto injector, a pen injector, a wearable injector, and/or a passive needle guard. For example, injection device 102 may include the BD Intevia™ autoinjector, the BD Libertas™ wearable autoinjector, the BD Sonic™ autoinjector, and/or the BD UltraSafe Plus™ passive needle guard for a pre-filled ISO standard glass syringe. As an example,
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Sensor assembly 104 may include a housing 140 and a mechanical interface 142. Housing 140 may include (e.g., house, encompass, etc.) a sensor 144, a processor 146, a wireless communication device 148, a user feedback device 150, a power source 152, a memory 154, and/or a real-time clock (RTC) 156.
Mechanical interface 142 may be configured to attach (e.g., removably attach, permanently attach, etc.) housing 140 to an exterior surface of injection device 102. For example, housing 140 may be removably attached to mechanical interface 142, permanently attached to mechanical interface 142, and/or integrated with mechanical interface 142. In some non-limiting embodiments or aspects, mechanical interface 142 is configured to index a position of sensor 144 relative to drug inspection window 120 of injection device 102 and/or component 122 within injection device 102. For example, sensor 144 may be calibrated according to the indexed position of the sensor relative to drug inspection window 120 of injection device 102 and/or a position of component 122 within injection device 102. As an example, a first mechanical interface 142 may be configured to index a position of sensor 144 relative to drug inspection window 120 of injection device 102 and/or component 122 within injection device 102 for a first type of injection device 102, and a second mechanical interface 142 may be configured to index a position of sensor 144 relative to drug inspection window 120 of injection device 102 and/or component 122 within injection device 102 for a second type of injection device 102 different than the first type of injection device. Further details regarding non-limiting embodiments or aspects of mechanical interface 142 are provided below with regard to
Sensor 144 may be configured to detect a movement of component 122 of injection device 102 associated with an injection operation of injection device 102. For example, sensor 144 may be configured to detect a movement (e.g., a movement, a displacement, etc.) of at least one of a piston, a stopper of a plunger, a rod of the plunger, and a mobile trigger that initiates or triggers the movement of the plunger. In some non-limiting embodiments or aspects, sensor 144 may include at least one of the following types of sensors: an optical sensor, an acoustic sensor, a vibration sensor, an acceleration sensor, a magnetic sensor, or any combination thereof. Further details regarding non-limiting embodiments or aspects of sensor 144 are provided below with regard to
Processor 146 may be programmed and/or configured to determine, based on a signal or sensor data received from sensor 144, information associated with a movement of component 122 of injection device 102. In some non-limiting embodiments or aspects, processor 146 may include a low power microcontroller unit (MCU). In some non-limiting embodiments or aspects, information associated with movement of component 122 of injection device 102 includes at least one of the following: a start time of the injection operation, a duration of the injection operation, an end time of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, a time of a needle shield deployment, a measured internal noise or vibration of injection device 102 (e.g., an acoustic and/or vibration profile, etc.), a measured injection force (e.g., a spring force, etc.) or any combination thereof. Processor 146 may store information associated with movement of component 122 of injection device 102 in memory 154.
Wireless communication device 148 may be configured to wirelessly communicate with computing device 106. For example, wireless communication device 148 may be configured to communicate information associated with movement of component 122 of injection device 102 to computing device 106. In some non-limiting embodiments or aspects, wireless communication device 148 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 enables wireless communication device 148 to receive information directly from and/or communicate information directly to computing device 106 via a short range wireless communication connection (e.g., a communication connection that uses NFC protocol, a communication connection that uses Radio-frequency identification (RFID), a communication connection that uses a Bluetooth® wireless technology standard, and/or the like).
User feedback device 150 may be configured to provide an indication associated with an injection operation and/or information associated with movement of component 122 of injection device 102 to a user. For example, user feedback device 150 may include at least one of the following: a display, a light-emitting diode (LED), an audio output device (e.g., a buzzer, a speaker, etc.), a tactile or haptic feedback device (e.g., a vibrator, etc.) or any combination thereof.
Power source 152 may be configured to power sensor 144, processor 146, wireless communication device 148, user feedback device 150, memory 154, and/or RTC 156. For example, power source 152 may include a battery (e.g., a rechargeable battery, a disposable battery, etc.), an energy harvester (e.g., an energy harvester configured to derive energy from one or more external sources, such as electromagnetic energy, solar energy, thermal energy, wind energy, salinity gradients, kinetic energy, and/or the like, etc.), or any combination thereof.
Memory 154 may be configured to store information associated with movement of component 122 of injection device 102 in memory 154. In some non-limiting embodiments or aspects, memory 154 may store calibration data associated with one or more calibration settings of sensor 144. For example, sensor 144 may be calibrated according to an indexed position of sensor 144 relative to drug inspection window 120 of injection device 102. As an example, mechanical interface 142 may be configured to index a position of sensor 144 relative to drug inspection window 120 of injection device 102.
RTC 156 may include a computer clock (e.g., in the form of an integrated circuit, etc.) that keeps track of the current time. For example, processor 146 may time stamp information associated with a movement of component 122 of injection device 102 based on the current time of RTC 156.
Computing device 106 may include one or more devices capable of receiving information and/or data from sensor assembly 104 and/or one or more other computing devices and/or communicating information and/or data to sensor assembly 104 and/or the one or more other computing devices. For example, computing device 106 may include a computing device, a server, a group of servers, a mobile device, a group of mobile devices, a receiving unit, a router device, a bridge device, a hub device, and/or the like. In some non-limiting embodiments or aspects, 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 enables computing device 106 to receive information directly from and/or communicate information directly to wireless communication device 148 via a short range wireless communication connection (e.g., a communication connection that uses NFC protocol, a communication connection that uses Radio-frequency identification (RFID), a communication connection that uses a Bluetooth® wireless technology standard, and/or the like). In some non-limiting embodiments or aspects, computing device 106 may include and/or upload information and/or data to an electronic data management system, such as a hospital record system, a system used during a clinical trial to collect the trial related information, and/or the like.
The number and arrangement of devices and systems shown in
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In some non-limiting embodiments or aspects, base plate 202 may include an external feature (e.g., a clamshell, etc.), and sensor assembly 104 may be integrated in the external feature (e.g., within the clamshell, etc.)
In some non-limiting embodiments or aspects, base plate 202 may include an external surface of injection device 102. For example, base plate 202 may be integrated with the external surface of injection device 102.
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Processor 146 may be programmed and/or configured to receive acquisition signals from acoustic or vibration sensor 744. Based on the received acquisition signals, processor 146 may be programmed and/or configured to perform signal processing (e.g., filtering, pattern detection etc.) on the received signals, perform threshold level(s) extraction, and/or determine information associated with a movement of component 122 of injection device 102. For example, processor 146 may be programmed and/or configured to compare a signal received from acoustic or vibration sensor 744 to one or more reference signals (e.g., stored in memory 154, etc.) to determine at least one of the following: a start time of the injection operation, a duration of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, or any combination thereof.
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Although embodiments or aspects have been described in detail for the purpose of illustration and description, it is to be understood that such detail is solely for that purpose and that embodiments or aspects are not limited to the disclosed embodiments or aspects, but, on the contrary, are intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. In fact, any of these features can be combined in ways not specifically recited in the claims and/or disclosed in the specification. Although each dependent claim listed below may directly depend on only one claim, the disclosure of possible implementations includes each dependent claim in combination with every other claim in the claim set.
Number | Date | Country | Kind |
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20305683.3 | Jun 2020 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/066851 | 6/21/2021 | WO |