Patent Application
20230390504
The present invention relates generally to drug delivery devices and components therefor, and in particular, to components allowing for detection and communication of the injection status of drug delivery devices.
Drug delivery devices have traditionally lacked features that would allow a healthcare provider to confirm appropriate administration of medicaments. Ensuring timely, appropriate administration of some medicaments can be critical, particularly, for example, in the instance of the evaluation of new drugs in clinical trials, where accurate information is essential.
While some devices provide the ability to communicate certain types of information, for example as described in International Patent Application Publication Nos. WO 2016/087512, WO 2017/070391, WO 2018/111969, WO 2018/213837, and WO 2021/094797, and in U.S. Patent Application Publication Nos. 2019/0083708, 2019/0321555, and 2019/0344019, a need exists in the art for a cost-effective device that accurately detects injection status, and can communicate this drug delivery information to appropriate stakeholders.
Provided herein is a drug delivery device including a syringe barrel having a proximal end, a distal end, and a sidewall arranged between the proximal end and the distal end defining an interior configured to hold a composition, a plunger rod received at least partially within the interior of the syringe, the plunger rod having a proximal end, a distal end, and a stopper arranged at the distal end, and a sensor assembly, including a capacitive element and a short-range communication device in electrical communication with the capacitive element, wherein the short-range communication device is capable of measuring capacitance at the capacitive element.
Also provided herein is a system including a drug delivery device including a syringe barrel having a proximal end, a distal end, and a sidewall arranged between the proximal end and the distal end defining an interior configured to hold a composition, a plunger rod received at least partially within the interior of the syringe, the plunger rod having a proximal end, a distal end, and a stopper arranged at the distal end, and a sensor assembly, including a capacitive element and a short-range communication device in electrical communication with the capacitive element, wherein the short-range communication device is capable of measuring capacitance at the capacitive element. The system also includes an NFC-enabled mobile device.
Also provided herein is a method of monitoring drug delivery status, including steps of providing a drug delivery device including a syringe barrel having a proximal end, a distal end, a needle arranged at the distal end, and a sidewall arranged between the proximal end and the distal end defining an interior configured to hold a composition, a plunger rod received at least partially within the interior of the syringe, the plunger rod having a proximal end, a distal end, and a stopper arranged at the distal end, and a sensor assembly, including a capacitive element and a short-range communication device in electrical communication with the capacitive element, wherein the short-range communication device is capable of measuring capacitance at the capacitive element, powering, with a mobile device, the sensor assembly to obtain first capacitance data, and transmitting, with the short-range communication device and to the mobile device, the first capacitance data.
The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
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. Any known electronic communication protocols, including proprietary communication protocols, and/or algorithms can be used such as, for example, TCP/IP (including HTTP and other protocols), WLAN (including 502.11a/b/g/n and other radio frequency-based protocols and methods), analog transmissions, Global System for Mobile Communications (GSM), UltraWideB and (UWB), 3G/4G/LTE, BLUETOOTH, ZigBee, EnOcean, TransferJet, Wireless USB, and the like known to those of skill in the art. In some non-limiting embodiments, a message may refer to a network packet (e.g., a data packet and/or the like) that includes data.
As used herein, the term “computing device” may refer to one or more electronic devices configured to process data. A computing device may, in some examples, include the necessary components to receive, process, and output data, such as a processor, a display, a memory, an input device, a network interface, and/or the like. A computing device may be a mobile device. As an example, a mobile device may include a cellular phone (e.g., a smartphone or standard cellular phone), a portable computer, a wearable device (e.g., watches, glasses, lenses, clothing, and/or the like), a personal digital assistant (PDA), and/or other like devices. A computing device may also be a desktop computer or other form of non-mobile computer.
As used herein, “electrical communication,” refers to a state of communication, for example through a conductive lead, antenna, etc., between one or more capacitive elements, such as a capacitor, and a short-range communication device, such as an NFC or RFID chip/tag, whereby the NFC or RFID chip/tag is capable of detecting and/or measuring a change in capacitance at the capacitive element(s).
Provided herein are drug delivery devices, systems including drug delivery devices, and methods using such systems and devices. Drug delivery devices described herein, as well as systems and methods including the same, include a sensor assembly including a short-range communication device to allow for monitoring of status of the drug delivery device, and communication of that status.
Turning to
With reference to
As noted above, sensor assembly 160 includes at least one capacitive element 150. In non-limiting embodiments, at least one capacitive element 150 includes a pair of capacitor plates. Suitable materials for capacitor plates are known to those of skill in the art. Those of skill in the art will also appreciate that the electrical field stored by a capacitor is influenced by the arrangement of the capacitor (e.g., size of and distance between capacitor plates) and the local environment, including materials surrounding and/or adjacent to the capacitor. As the capacitive element 150 is in electrical communication (e.g., via one or more leads) with short-range communication device 140 (and any optional further communication devices, such as an RFID device), short-range communication device (e.g., NFC chip) 140 can, when powered, detect and/or determine capacitance at the capacitive element 150, which, as noted, may be affected by surrounding/adjacent materials. In non-limiting embodiments, sensor assembly 160 is arranged at or near distal end 114 of needle shield 110. In non-limiting embodiments, capacitive element 150 includes a pair of capacitor plates arranged parallel to one another. In non-limiting embodiments, capacitive element 150 includes capacitor plates separated from one another by air or an insulating material, such as ceramic, glass, paper, and/or plastic.
For example, with reference to
Turning to
As shown in
While the illustrated embodiments (e.g.,
Turning to
Referring now to
Drug delivery device 502, which can be a rigid drug container, a syringe, autoinjector, wearable injector, and/or pump as described herein, can include, as described above, a sensor assembly including short-range communication device 504 and capacitive element(s). As described above, drug delivery device 502 can be configured to communicate with a user device 506.
User device 506 can be a computing device as described herein, in some non-limiting embodiments, a smartphone. User device 506 can be programmed or configured to communicate, for example through communication network 508, with a healthcare system 510, for example through a mobile application executable on user device 506.
Communication network 508 may include one or more wired and/or wireless networks. For example, communication network 508 may include a BLUETOOTH connection (e.g., between drug delivery device 502 and user device 506), a cellular network (e.g., a long-term evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a fifth generation (5G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a UWB network, a local area network (LAN), a low-power wide area network (LPWAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., the public switched telephone network (PSTN) and/or the like), a private network, an ad hoc network, an intranet, the Internet, a fiber optic-based network, a cloud computing network, and/or the like, and/or a combination of some or all of these or other types of networks.
Healthcare system 510 may include a server, a group of servers, and/or other like devices. More than one healthcare system 510 can be provided, for example, a system associated with a device manufacturer, a system associated with a pharmaceutical manufacturer, a system associated with a healthcare provider, a system associated with a government agency, and/or a system associated with a study sponsor, for example a sponsor of a clinical trial.
Referring now to
Bus 602 may include a component that permits communication among the components of a computing device 600. In some non-limiting embodiments, processor 604 may be implemented in hardware, software, or a combination of hardware and software. For example, processor 604 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), and/or the like), a microprocessor, a digital signal processor (DSP), and/or any processing component (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), and/or the like) that can be programmed to perform a function. Memory 606 may include random access memory (RAM), read-only memory (ROM), and/or another type of dynamic or static storage memory (e.g., flash memory, magnetic memory, optical memory, and/or the like) that stores information and/or instructions for use by processor 604.
Storage component 608 may store information and/or software related to the operation and use of computing device 600. For example, storage component 608 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optic disk, a solid state disk, and/or the like), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and/or another type of computer-readable medium, along with a corresponding drive.
Input component 610 may include a component that permits computing device 600 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, and/or the like). Additionally or alternatively, input component 610 may include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, and/or the like). Output component 612 may include a component that provides output information from a computing device (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), and/or the like).
Communication interface 614 may include a transceiver-like component (e.g., a transceiver, a separate receiver, and transmitter, etc.) that enables device to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interface 614 may permit computing device 600 to transmit and/or receive information from another device. For example, communication interface 614 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, a cellular network interface, BLUETOOTH interface, UWB interface, and/or the like. In non-limiting embodiments, communication interface 614 operates through one or both of near-field communication and RFID. Suitable communication protocols and methods for securing communications between communication interface 614 and a communication interface of another device, such as a computing device (e.g., desktop computer, laptop computer, smartphone, smart watch, PDA, tablet, etc.,) can include encryption, e.g., using a secure socket layer (SSL) (e.g., by using public/private key pairs as are known in the art). Additional security protocols are disclosed in, for example, U.S. Pat. Nos. 9,445,264 and 9,463,325, the contents of which are hereby incorporated by reference in their entirety.
A computing device may perform one or more processes described herein. A computing device may perform these processes based on processor 604 executing software instructions stored by a computer-readable medium, such as memory 606 and/or storage component 608, and/or being instructed by a separate computing device. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A non-transitory memory device includes memory space located inside of a single physical storage device or memory space spread across multiple physical storage devices.
Software instructions may be read into memory 606 and/or storage component 608 from another computer-readable medium or from another device via communication interface 614. When executed, software instructions stored in memory 606 and/or storage component 608 may cause processor 604 to perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, embodiments described herein are not limited to any specific combination of hardware circuitry and software.
With reference once again to
In non-limiting embodiments, short-range communication device 504 is in one-way communication with a user's computing device 506, e.g., the short-range communication device 504 can only transmit data to the user device 506, and cannot receive data from the user device 506.
As described above, in non-limiting embodiments, upon being placed near drug delivery device 502, user's computing device 506, by virtue of being enabled for NFC, can deliver power to sensor assembly including short-range communication device 504, which can, based on short-range communication device 504 being in electrical communication with capacitive elements, generate and/or record first, second, third, etc. capacitance data which may be transmitted to user's computing device 506, optionally with one or more identifiers (e.g., a device identifier, drug identifier, lot identifier, and/or an identifier associated with short-range communication device 504). In non-limiting embodiments, capacitance data and/or one or more identifiers are encrypted before being transmitted to user device 506. In addition, other sensors can be provided that are in communication with short-range communication device 504 (or any other included communication device, such as an RFID device) and allow for transmission of, for example, GPS data, gyroscope data, temperature data, humidity data, light exposure data, and the like, which may be relevant to any composition that is to be held within drug delivery device 502.
In non-limiting embodiments, user device 506 and/or healthcare system 510, based on software installed thereon, may compare first, second, etc. capacitance data received from drug delivery device 502 to one or more pre-determined capacitance values. Such pre-determined capacitance values may be stored in memory of user device 506 and/or healthcare system 510, and may include predicted or actual capacitance values for various stages of drug delivery. For example, pre-determined capacitance values may include capacitance measured when the syringe is full of a composition (e.g., plastic, glass, a higher density of metal from a compressed needle shield spring, and/or the composition are adjacent capacitive element(s)) (pre-injection), and/or when the syringe has been actuated (e.g., plastic, glass, the rubber stopper, and or a lower density of metal from an expanded spring) are adjacent capacitive element(s)) (post-injection). Results of the comparison(s), as well as received capacitance data and/or one or more identifiers and/or additional data described herein, may be stored on one or both of user device 506 and/or healthcare system 510, and transmitted therebetween via network 508. In non-limiting embodiments, if any capacitance data falls outside of a predetermined range, a message can be generated by or sent to user device 506. In addition, data may be stored by user device 506 and/or healthcare system 510, such that if a particular sensor assembly (e.g., short-range communication device 504) is believed to have not been used previously, but data is detected and/or stored that is indicative of capacitance in a post-use configuration, an alert may be sent to the user device 506 that the drug delivery device 502 may have been previously used or may have been tampered with.
In non-limiting embodiments, healthcare system 510 may be in communication with one or more additional healthcare systems 510. For example, one healthcare system may be maintained by the device manufacturer, and may be in communication with a healthcare system maintained by a study sponsor, pharmaceutical manufacturer, or the like. In non-limiting embodiments, capacitance data (first capacitance data, second capacitance data, etc. and/or any comparisons between the measured capacitance data and predetermined capacitance levels), together with one or more identifiers (e.g., a device identifier and/or an identifier associated with the short-range communication device 504), may be transmitted from device manufacturer system to study sponsor or pharmaceutical manufacturer system, where one or more databases may store data associating the one or more identifiers (e.g., a device identifier and/or an identifier associated with the short-range communication device 504) with a patient identifier, allowing for association of any collected data with the patient.
Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments, but, on the contrary, is 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 can be combined with one or more features of any other embodiment.
| Number | Date | Country | Kind |
|---|---|---|---|
| 22176651.2 | Jun 2022 | EP | regional |
