The present application claims priority to European Patent Application No. 20306153.6, entitled “Injection Device with Sensor Assembly”, filed Oct. 5, 2020, the entire disclosure of which is hereby incorporated by reference in its entirety.
The present disclosure relates generally to an injection device and, in some non-limiting embodiments or aspects, to a spring-based injection device including a sensor assembly.
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 injection related data.
Accordingly, provided are improved systems, devices, products, apparatus, and/or methods for capturing and/or transferring injection related data.
According to some non-limiting embodiments or aspects, provided is an injection device for delivering a dose of medicament to a user, the injection device including: a container having an open proximal end, a substantially closed distal end, and a reservoir defined between the open proximal end and the substantially closed distal end, the reservoir including the medicament; a mobile component provided in the container and movable with respect to the container, a movement of the moveable component causing the medicament to be expelled from the container; a spring connected to the mobile component, wherein the spring is configured to cause the mobile component to move within the container to cause the medicament to be expelled from the container; a sensor connected to an end of the spring, wherein the sensor is configured to measure a parameter 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 injection operation of the injection device.
Further embodiments or aspects are set forth in the following numbered clauses:
Clause 1. An injection device for delivering a dose of medicament to a user, the injection device comprising: a container having an open proximal end, a substantially closed distal end, and a reservoir defined between the open proximal end and the substantially closed distal end, the reservoir including the medicament; a mobile component provided in the container and movable with respect to the container, a movement of the moveable component causing the medicament to be expelled from the container; a spring connected to the mobile component, wherein the spring is configured to cause the mobile component to move within the container to cause the medicament to be expelled from the container; a sensor connected to an end of the spring, wherein the sensor is configured to measure a parameter 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 injection operation of the injection device.
Clause 2. The injection device of clause 1, wherein the mobile component includes a plunger rod and a stopper.
Clause 3. The injection device of any of clauses 1 and 2, wherein the sensor connected to the end of the spring is in contact with the stopper.
Clause 4. The injection device of any of clauses 1-3, wherein the end of the spring connected to the sensor is opposite another end of the spring in contact with the stopper.
Clause 5. The injection device of any of clauses 1-4, further comprising: an electrically conductive trace that connects the sensor to the wireless communication device.
Clause 6. The injection device of any of clauses 1-5, wherein the spring forms at least a portion of the electrically conductive trace.
Clause 7. The injection device of any of clauses 1-6, further comprising: a first housing including the container, the mobile component, the spring, the sensor, and the wireless communication device, wherein the sensor is spaced apart from the wireless communication device within the housing.
Clause 8. The injection device of any of clauses 1-7, further comprising: a first housing including the container, the mobile component, the spring, and the sensor; and a second housing including the wireless communication device, wherein the second housing is connected to an external surface of the first housing.
Clause 9. The injection device of any of clauses 1-8, further comprising: a battery configured to provide power to the sensor via the electrically conductive trace.
Clause 10. The injection device of any of clauses 1-9, wherein the sensor includes an adapter plate having a hollow cylinder shape.
Clause 11. The injection device of any of clauses 1-10, further comprising: one or more processors programmed and/or configured to determine, based on the measured parameter, the information associated with the injection operation of the injection device.
Clause 12. The injection device of any of clauses 1-11, wherein the information associated with the injection operation of the injection device includes 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.
Clause 13. The injection device of any of clauses 1-12, further comprising:
Clause 14. The injection device of any of clauses 1-13, wherein the sensor includes a force sensor configured to measure a force associated with the injection operation of the injection device.
Clause 15. The injection device of any of clauses 1-14, wherein the sensor includes an accelerometer configured to measure an acceleration associated with the injection operation of the injection device.
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.).
Referring to
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, a passive needle guard, and/or the like. For example, injection device 102 may include the BD Intevia™ autoinjector, the BD Libertas™ wearable autoinjector, the BD Sonic™ autoinjector, the BD UltraSafe Plus™ passive needle guard for a pre-filled ISO standard glass syringe, and/or the like. As an example,
Computing device 104 may include one or more devices capable of receiving information and/or data from injection device 102 (e.g., from sensor module 210, etc.) and/or communicating information and/or data to injection device 102 (e.g., to sensor module 210, etc.). For example, computing device 104 may include a computing device, a server, a group of servers, a mobile device, a group of mobile devices, a bridge, a router, a hub, and/or the like. In some non-limiting embodiments or aspects, computing device 104 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 104 to receive information directly from and/or communicate information directly to injection device (e.g., wireless communication device 216, etc.) 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 104 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, and/or to another computing device.
Referring now to
Container 202 may have an open proximal end, a substantially closed distal end, and a reservoir defined between the open proximal end and the substantially closed distal end. The reservoir may include a medicament.
Mobile component 204 may be provided in container 202 (e.g., received in the open proximal end of container 202, etc.) and be movable with respect to container 202. For example, a movement of movable component 204 may cause the medicament to be expelled from the container in an injection operation (e.g., expelled from the substantially closed end of container 202 via a needle connected thereto, etc.). As an example, mobile component 204 may include plunger rod 204a and stopper 204b.
Spring 206 may be connected to mobile component 204. For example, spring 206 may be configured to cause mobile component 204 to move within container 202 to cause the medicament to be expelled from container 202. As an example, spring 206 may be held in a compressed position until a trigger that initiates or triggers the injection operation (e.g., a button, a trigger, etc.) is actuated or displaced release spring 206 from its compressed position to cause mobile component 204, which is connected to spring 206, to move distally within container 202 to cause the medicament to be expelled from container 202. In such an example, spring 206 may expand to cause plunger rod 204a and stopper 204b to move distally within container 202. Although
Sensor 208 may be connected to (e.g., directly connected to, directly attached to, integrated with, etc.) an end of spring 206. For example, sensor 208 may be connected to a distal end and/or a proximal end of spring 206. As an example, sensor 208 may be connected to an end of spring 206 in contact with stopper 204a opposite a base of spring 206. In such an example, sensor 208 may be in contact with stopper 204b. As an example, sensor 208 may be connected to another end of spring 206 that is opposite an end of spring 206 that is in contact with stopper 204b. In some non-limiting embodiments or aspects, a first sensor 208 (e.g., a force sensor, an accelerometer, etc.) may be connected to a first end of spring 206 and a second sensor 208 (e.g., an accelerometer, a force sensor, etc.) may be connected to a second end of spring 206 opposite the first end of spring 206.
Sensor 208 may be configured to measure a parameter associated with an injection operation of injection device 102. Sensor 208 may include a force sensor, an accelerometer, or any combination thereof. For example, sensor 208 may include a force sensor (e.g., a strain gauge, an extensometer sensor, a piezoelectric sensor, etc.) configured to measure a force associated with an injection operation of injection device 102. As an example, sensor 208 may measure a mechanical deformation of a force applied to an object where sensor 208 is positioned (e.g., a force applied at an end of spring 206, a force applied to mobile component 204, etc.) and transform the measured parameter into an electrical signal for processing and/or communication at sensor module 210. For example, sensor 208 may include an accelerometer configured to measure an acceleration associated with the injection operation of the injection device. As an example, sensor 208 may measure a speed of displacement of an object (e.g., an end of spring 206, mobile component 204, etc.) on which sensor 208 is positioned along one or more axes of the object and transform the measured parameter into an electrical signal for processing and/or communication at sensor module 210.
As shown in
Electrically conductive trace 209 may connect processor 214, wireless communication device 216, user feedback device 218, power source 220, and/or memory 222 to sensor 208. In some non-limiting embodiments or aspects, at least a portion of electrically conductive trace 209 is integrated in housing 200 (e.g., integrated in a plastic molded housing of injection device 102, etc.). In some non-limiting embodiments or aspects, spring 206 (e.g., a metal spring, an electrically conductive spring, etc.) forms at least a portion of electrically conductive trace 209. For example, as shown in
Processor 214 may be programmed and/or configured to determine, based on a signal or sensor data (e.g., a measured parameter, a measured force, a measured acceleration, etc.) received from sensor 208, information associated with an injection operation of injection device 102. For example, processor 214 may be programmed and/or configured to receive acquisition signals from sensor 208 and, based on the received acquisition signals, processor 214 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 an injection operation of injection device 102. As an example, processor 214 may be programmed and/or configured to compare a signal received from sensor 208 to one or more reference signals (e.g., stored in memory 222, 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. 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 an injection operation of injection device 102 includes at least one of the following: a measured parameter, a measured force, a measured acceleration, 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. Processor 214 may store information associated an injection operation of injection device 102 in memory 222.
Wireless communication device 216 may be configured to wirelessly communicate with computing device 104. For example, wireless communication device 216 may be configured to communicate information associated with an injection operation of injection device 102 to computing device 104. In some non-limiting embodiments or aspects, wireless communication device 216 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 216 to receive information directly from and/or communicate information directly to computing device 104 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 104 may be programmed and/or configured to determine, based on a signal or sensor data (e.g., a measured parameter, a measured force, a measured acceleration, etc.) received from sensor 208 via wireless communication device 216, information associated with an injection operation of injection device 102. For example, computing device 104 may be programmed and/or configured to receive acquisition signals from sensor 208 via wireless communication device 216 and, based on the received acquisition signals, computing device 104 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 an injection operation of injection device 102. As an example, computing device 104 may be programmed and/or configured to compare a signal received from sensor 208 via wireless communication device 216 to one or more reference signals (e.g., stored in a memory, 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.
User feedback device 218 may be configured to provide an indication and/or information associated with an injection operation 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.), or any combination thereof. In some non-limiting embodiments or aspects, user feedback device 218 may include an user input device configured to receive user input from a user.
Power source 220 may be configured to power sensor 208, processor 214, wireless communication device 216, user feedback device 218, and/or memory 222. For example, power source 220 may include a battery (e.g., a rechargeable battery, a disposable battery, etc.) and/or an energy harvester (e.g., a thermoelectric energy harvester, a photovoltaic energy harvester, a piezoelectric energy harvester, etc.)
Memory 222 may be configured to store information associated with an injection operation of injection device 102 in memory 222. In some non-limiting embodiments or aspects, memory 222 may store calibration data associated with one or more calibration settings of sensor 208.
The number and arrangement of devices and systems shown in
Referring now to
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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20306153.6 | Oct 2020 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/077268 | 10/4/2021 | WO |