Drug delivery device with skin contact sensor
By integrating sensors and microcontrollers in the wearable drug delivery device, real-time monitoring of the contact status of the device and the skin, the problem of failure caused by the separation of the device after drug delivery is solved, and the reliability and safety of drug delivery are achieved.
Patent Information
- Application Number
- CN202380060010.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-09-09
- Filing Date
- 2023-09-08
- Publication Date
- 2025-03-28
AI Technical Summary
Existing wearable drug delivery devices may cause the device to separate from the skin after drug delivery, resulting in failure of drug delivery, and this failure is often silent and difficult for patients to detect.
A wearable drug delivery device including a microcontroller, sensor, container and cannula is designed. The sensor is used to detect the contact state of the device and the skin. The microcontroller receives sensor data to determine whether the device is correctly arranged on the skin and provides feedback and alarms if necessary.
By monitoring the contact status of the device and the skin in real time, ensure that the drug delivery device works in the correct position and orientation, avoiding drug delivery failure, and improving the reliability and safety of delivery.
Smart Images

Figure CN119730892A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to U.S. Provisional Application No. 63 / 405,099, filed on September 9, 2022, entitled “Drug Delivery Device with Skin Contact Sensor,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field
[0003] The present disclosure relates to wearable drug delivery devices, and more particularly to wearable drug delivery devices capable of detecting separation of the device from the skin of a user. Background Art
[0004] Medical devices such as wearable injectors, auto-injectors, and other drug delivery devices have the advantage of providing treatment to a patient at a location remote from a clinical facility and / or when the medical device is worn separately under the patient's clothing. The wearable medical device can be applied to the patient's skin and configured to automatically deliver a dose of a pharmaceutical composition over a predetermined period of time. After the device delivers the pharmaceutical composition to the patient, the patient can then remove and dispose of the device.
[0005] In some cases, the drug delivery device must be worn for a period of time (for minutes, hours, or days) before drug delivery. In other cases, injections are administered over a longer period of time or multiple consecutive injections (e.g., insulin, Alzheimer's drugs, Parkinson's drugs, chemotherapy, etc.). In these cases, a soft catheter can be used. However, device (partial, complete, temporary and / or permanent) separation may cause the catheter to migrate outside the target injection site and cause failure. In addition, such failures may be silent and may not be noticed by the patient. Therefore, there is a need in the art for robust sensors and alarms for wearable drug delivery devices. Summary of the invention
[0006] Provided herein is a wearable drug delivery device comprising: a housing having a skin-facing surface defining a sleeve opening, the skin-facing surface being configured to be releasably attached to the patient's skin; a microcontroller received within the housing and comprising at least one processor; a sensor communicating with the microcontroller, the sensor being configured to detect the patient's skin; a container disposed within the housing and configured to store a drug composition therein; and a sleeve being fluidly connected to the container, the sleeve being capable of being converted from an initial position, in which the sleeve is disposed within the housing, to a use position, in which the sleeve extends through the sleeve opening.
[0007] In one embodiment, the sensor is a proximity sensor.
[0008] In one embodiment, the drug delivery device is securable to a patient.
[0009] In one embodiment, the drug delivery device is a wearable device.
[0010] In one embodiment, the proximity sensor is a capacitive sensor, an inductive sensor, and / or an ultrasonic sensor.
[0011] In one embodiment, the sensor is an ultrasonic sensor and includes a transmitter and a receiver.
[0012] In one embodiment, the sensor is an optical sensor.
[0013] In one embodiment, the optical sensor includes a transmitter and a receiver.
[0014] In one embodiment, the drug delivery device further comprises an adhesive patch arranged between the housing and the patient's skin.
[0015] In one embodiment, the sensor is at least partially arranged within the adhesive patch and / or on a surface of the adhesive patch.
[0016] In one embodiment, the sensor includes severable circuits, strain gauges, and / or piezoelectric materials.
[0017] In one embodiment, the adhesive patch includes one or more openings therethrough, and wherein the sensor is aligned with the one or more openings.
[0018] In one embodiment, the sensor is an optical sensor or an ultrasonic sensor.
[0019] In one embodiment, the sensor includes a transmitter and a receiver.
[0020] In one embodiment, the sensor comprises a switch.
[0021] In one embodiment, the switch is a mechanical switch.
[0022] In one embodiment, the processor is programmed or configured to: receive data from the sensor related to whether the drug delivery device is in contact with the patient's skin; and determine whether the wearable drug delivery device is properly placed on the patient's skin based on the state of the wearable drug delivery device and the data.
[0023] In one embodiment, the processor is programmed or configured to provide feedback indication to the patient based on at least one of proper placement and orientation of the device.
[0024] In one embodiment, the processor is programmed or configured to provide instructions to adjust or correct placement of the drug delivery device before, during, and / or after an injection.
[0025] In one embodiment, the wearable drug delivery device further comprises at least one of an indicator capable of communicating a condition of the wearable drug delivery device to a user and a communication module configured to transmit data related to a state of at least one attribute of the wearable drug delivery device.
[0026] In one embodiment, at least one processor is further programmed or configured to provide an alert via the indicator and / or the communication module upon determining that the wearable drug delivery device is not properly positioned on the patient's skin.
[0027] In one embodiment, the alert is an audible indication, a tactile indication, and / or a visual indication.
[0028] In one embodiment, the container is a flexible container.
[0029] In one embodiment, the container is a syringe barrel.
[0030] In one embodiment, the device further comprises a motor configured to expel the pharmaceutical composition from the container.
[0031] In one embodiment, data received from the sensor is used to determine whether the delivery device should refrain from completing the delivery or should continue the delivery if contact with the patient is lost before the second condition is satisfied.
[0032] In one embodiment, the second condition is at least one of: delivery completion, a pressure change below a threshold indicating tissue resorption, and deployment or removal of an insertion mechanism. BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Figure 1 is a perspective view of a drug delivery device according to one aspect or embodiment of the present application;
[0034] Figure 2 The top cover is removed Figure 1 A three-dimensional view of a drug delivery device;
[0035] Figure 3 yes Figure 1 Schematic diagram of a drug delivery device;
[0036] Figure 4 yes Figure 1 Schematic diagram of a drug delivery device;
[0037] Figure 5 yes Figure 1 Schematic diagram of a drug delivery device;
[0038] Figure 6 yes Figure 1 Schematic diagram of a drug delivery device;
[0039] Figure 7 is a schematic diagram of a non-limiting embodiment or aspect of an environment in which the systems, apparatuses, and / or methods described herein may be implemented; and
[0040] Figure 8 yes Figure 7 Schematic diagram of a non-limiting embodiment or aspect of components of one or more devices. DETAILED DESCRIPTION
[0041] The following description is provided to enable those skilled in the art to produce and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutes will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.
[0042] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may present various alternative variations unless expressly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.
[0043] All numbers used in the specification and claims are to be understood as being modified in all cases by the term "about". "About" refers to a range of plus or minus ten percent of the specified value. As used in the specification and claims, the singular forms "a", "an", and "the" include plural references unless the context clearly indicates otherwise. The terms "first", "second", etc. do not refer to any particular order or sequence, but rather to different conditions, characteristics, or elements. "At least" means "greater than or equal to".
[0044] As used herein, the term "cannula" may refer to needles, cannulas, catheters, and similar structures that allow fluid communication between a pharmaceutical composition container and a patient.
[0045] As used herein, the term "patient" may refer to a human or a non-human animal.
[0046] As used herein, the terms "communication" and "transmission" refer to the reception or transmission of one or more signals, messages, commands or other types of data. A unit (for example, any device, system or its parts) communicates with another unit and means that the unit can directly or indirectly receive data from the other unit and / or send data to the other unit. This can refer to a direct connection or indirect connection that is wired and / or wireless in nature. In addition, although the data sent can be modified, processed, relayed and / or routed between the first unit and the second unit, the two units can still communicate with each other. For example, even if the first unit passively receives data and does not actively send data to the second unit, the first unit can also communicate with the second unit. As another example, if the intermediate unit processes the data from a unit and sends the processed data to the second unit, the first unit can communicate with the second unit. It should be understood that many other arrangements are possible. Any known electronic communication protocol and / or algorithm may be used, such as Transmission Control Protocol / Internet Protocol (TCP / IP) (including Hypertext Transfer Protocol (HTTP) and other protocols), Wireless Local Area Network (WLAN) (including 802.11a / b / g / n and other radio frequency-based protocols and methods), analog transmission, Global System for Mobile Communications (GSM), third generation (3G) / fourth generation (4G) / long term evolution (LTE), Bluetooth (BLUETOOTH), ZigBee, EnOcean, TransferJet, and Wireless USB, etc., known to those skilled in the art. In some non-limiting embodiments, a message may refer to a network packet (e.g., a data packet, etc.) including data.
[0047] As used herein, the term "computing device" may refer to one or more electronic devices configured to process data. In some examples, the computing device may include components required to receive, process, and output data, such as a processor, a display, a memory, an input device, and / or a network interface. The computing device may be a mobile device. As an example, the mobile device may include a cellular phone (e.g., a smartphone or a standard cellular phone), a portable computer, a wearable device (e.g., a watch, glasses, lenses, and / or clothing, etc.), a personal digital assistant (PDA), and / or other similar devices. The computing device may also be a desktop computer or other form of non-mobile computer.
[0048] refer to Figure 1 and Figure 2 , the drug delivery device 10 includes a reservoir, an insertion mechanism 16, control electronics 18, a cap 20, and a base 22. In a non-limiting embodiment, the drug delivery device 10 is a wearable automatic injector (e.g., an insulin or bone marrow stimulant delivery device). The drug delivery device 10 can be mounted on the patient's skin and can be triggered to inject the drug composition from the reservoir 12 into the patient's body. The drug delivery device 10 can be pre-filled with the drug composition, or can be filled with the drug composition by the patient or a medical professional before use.
[0049] The drug delivery device 10 is configured to deliver a dose of a drug composition (e.g., any desired drug) to a patient via subcutaneous injection at a slow, controlled injection rate. An exemplary duration of delivery achieved by the drug delivery device 10 may be in the range of about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the drug composition delivered by the drug delivery device 10 may be in the range of about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The volume of the drug composition delivered to the patient may be adjusted.
[0050] refer to Figures 3 to 5 , the drug delivery device 10 may also include an adhesive patch 70 for securing the drug delivery device 10 to the patient's skin 80, and may also include a computing device (e.g., a microcontroller 24, and a sensor 26 in communication with the microcontroller). The microcontroller 24 may include one or more components of a computing device as described herein (and, for example, shown in FIG. 9 ), such as one or more processors, and, for example, an optional memory for storing programming instructions to provide the functionality described below. Figures 3 to 5 1 shows non-limiting examples of sensors that can be used to detect whether the drug delivery device 10 is in proximity to (eg, attached to) the patient's skin. Although capacitive sensors and / or inductive sensors ( Figure 3 ), optical sensors and / or ultrasonic sensors ( Figure 4 ) and sensors including separable circuits, strain gauges and / or piezoelectric materials ( Figure 5 ), but those skilled in the art will recognize that other sensors, including switches such as mechanical switches, may be used to determine proximity to the patient's skin. For example, the mechanical switch may be biased to the first configuration, for example, by a spring or other resilient member. When the drug delivery device 10 is properly applied to the patient's skin 80, the switch may remain in the second configuration against the biasing force. Upon partial and / or complete separation or removal from the skin 80, the switch may be partially or completely converted to the first configuration, which may be detected by the microcontroller 24, which may provide an alert to the patient for such a condition as described herein. In a non-limiting embodiment, the drug delivery device may include any type, number, and arrangement of sensors 26 as described herein.
[0051] Steering Figure 3 , shows a non-limiting embodiment in which the sensor 26 is a proximity sensor such as a capacitive sensor and / or an inductive sensor that can detect changes in the sensor's surroundings based on changes in the electric and / or magnetic fields due to the presence of different materials (e.g., air and skin) near the sensor. When processed by the microcontroller 24, the detected field changes can determine whether the drug delivery device 10 has moved relative to the patient's skin 80, such that the cannula 48 may not be at the proper injection depth or may not be able to reach the proper injection depth. Suitable capacitive sensors and inductive sensors are known to those skilled in the art and are commercially available.
[0052] refer to Figure 4, shows a non-limiting embodiment in which the sensor 26 is an optical sensor and / or an ultrasonic sensor. In a non-limiting embodiment, the optical sensor and / or ultrasonic sensor 26 includes an emitter 26a and a detector 26b, which may be in the same sensor unit or in different sensor units. In a non-limiting embodiment, the emitter 26a is a light-emitting diode (LED), and the detector 26b is a photodiode. In a non-limiting embodiment, the adhesive patch 70 includes one or more openings passing therethrough, and the sensor 26 (and / or its components, such as the emitter 26a and / or the detector 26b) may be aligned with the one or more openings so that in some embodiments, there is no adhesive pad between the sensor 26 and the patient's skin 80. As described above, when processed by the microcontroller 24, changes in the detected signal (e.g., an ultrasonic or optical signal) can determine whether the drug delivery device 10 has moved relative to the patient's skin 80, so that the cannula 48 may not be at the appropriate injection depth or may not reach the appropriate injection depth.
[0053] refer to Figure 5 , shows a non-limiting embodiment in which the sensor 26 is at least partially incorporated into the adhesive patch 70, for example, by a detachable circuit, a strain gauge, and / or a piezoelectric material. By "incorporated", it is contemplated that the sensor may be at least partially received within the adhesive patch 70 and / or on the surface of the adhesive patch 70. As described above, the adhesive patch 70 may have one or more openings 72 (e.g., corresponding to pre-cut or detachable portions of the patch 70). Such openings 72 may distinguish between portions of the patch 70 that are heat staked to the base of the drug delivery device 10 and those portions of the patch 70 that are not heat staked to the base. Such a sensor may, for example, detect changes in the orientation of the drug delivery device 10 relative to the patient's skin 80 based on deformation of the adhesive patch 70, which may include one or more portions of the sensor 26. As described above, changes in detected signals (e.g., circuit interruption, strain amplitude, and / or piezoelectric signal), when processed by the microcontroller 24, can determine whether the drug delivery device 10 has moved relative to the patient's skin 80 such that the cannula 48 may not be at the proper injection depth or may not be able to reach the proper injection depth.
[0054] In the non-limiting embodiment of the drug delivery device 10 described herein, the microcontroller 24 in communication with the sensor 26 can be programmed or configured to compare the signal received from the sensor 26 and compare it to an appropriate reference value corresponding to the type of sensor 26 included in the drug delivery device 10 to determine whether the drug delivery device 10 is properly arranged on the patient's skin 80. In a non-limiting embodiment, when it is determined that the drug delivery device 10 is not properly arranged on the patient's skin 80, an alarm can be sent by any visual, auditory and / or tactile means by means of the microcontroller 24 communicating with an appropriate type of indication device (e.g., a light source such as an LED, a speaker and / or a device that produces a tactile indication). In a non-limiting embodiment, the microcontroller 24 can also store data related to the arrangement of the drug delivery device 10 in a memory to provide a history for later review and / or comparison.
[0055] refer to Figure 6 , a schematic diagram of possible components of the drug delivery device 10 is shown. In a non-limiting embodiment, the drug delivery device 10 may include a power source 14. In a non-limiting embodiment, the power source 14 is a DC power source including one or more batteries, but those skilled in the art will understand that other power sources may be included. As described above, the drug delivery device 10 may also include control electronics 18, which includes a computing device (e.g., a microcontroller 24) that controls the activation of the drug delivery device 10, a sensor 26, a pump and valve controller 28, a sensing electronics 30, and a deployment electronics 32. The drug delivery device 10 includes a fluidics sub-system, which includes a reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a metering system 38, which includes a pump and valve actuator 40 (e.g., a motor) and a pump and valve mechanism 42. Those skilled in the art will understand that any suitable container may be used in the context of the present invention. For example, although Figure 6 Reference is made to a syringe having a fill port 36 and a reservoir 12, but other suitable containers such as flexible containers may be used with the present invention. The fluid subsystem may also include an occlusion sensor 44, a deployment actuator 46, a cannula 48 for insertion into the patient's skin, and a fluid line 50 in fluid communication with the reservoir 12 and the cannula 48. In one aspect or embodiment, the insertion mechanism 16 is configured to move the cannula 48 from a retracted position positioned completely within the device 10 to an extended position in which the cannula 48 extends outside the device 10. The drug delivery device 10 may operate in the same manner as discussed in U.S. Pat. No. 10,449,292, which is incorporated herein by reference in its entirety.
[0056] refer to Figure 7 , a schematic diagram of an example environment 700 in which the devices, systems, and / or methods described herein may be implemented is shown. The environment 700 may include a drug delivery device 702 (the drug delivery device 702 including a microcontroller 704 and one or more sensors described herein), a computing device (e.g., a mobile device 706 associated with a patient), and / or a communication network 708. The drug delivery device 702 and the mobile device 706 may be interconnected (e.g., connected to communicate) via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection.
[0057] The drug delivery device 702 may be a wearable drug delivery device as described herein, which may include one or more sensors as described above in communication with the microcontroller 704, which may also include a communication interface for sending data to and / or receiving data from the user device 706. One or both of the microcontroller 704 and the user device 706 may be a computing device as described herein, which may include a computing device as described herein and / or in Figure 8 Any components described below as illustrated in .
[0058] Communications network 708 may include one or more wired networks and / or wireless networks. For example, the communication network 708 may include a Bluetooth connection (e.g., a Bluetooth connection between the drug delivery device 702 and the user device 706), a cellular network (e.g., a Long-term Evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a fifth generation (5G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a low-power wide area network (LPWAN), an ultra-wideband network (UWB), a metropolitan area network (MAN), a telephone network (e.g., a public switched telephone network (PSTN)), etc.), a private network, an ad hoc network, an intranet, the Internet, a fiber-based network and / or a cloud computing network, etc., and / or a combination of some or all of these or other types of networks.
[0059] The user device 706 may be a computing device, a smartphone, a smart watch, a tablet computer, a laptop computer, a desktop computer, or other computing device as described herein in some non-limiting embodiments. The user device 706 may be programmed or configured to communicate with other systems (health care systems associated with drug manufacturers, device manufacturers, clinical trial sponsors, and / or physicians), for example, via a communication network 708 (e.g., via an application such as a mobile application that may be executed on the user device 706).
[0060] refer to Figure 8 , which shows a schematic diagram of example components of an exemplary computing device that can be used in the devices, systems, and methods described herein. For example, Figure 7As shown in the exemplary environment 700 of , such a computing device 900 can correspond to the components within the drug delivery device as described herein and / or a user device (e.g., a mobile phone, a tablet computer, a laptop computer, a smart watch or other personal communication device). As shown in FIG. 9 , the computing device 900 may include a bus 902, a processor 904, a memory 906, a storage component 908, an input component 910, an output component 912 and / or a communication interface 914.
[0061] The bus 902 may include components that allow communication between multiple components of the computing device 900. In some non-limiting embodiments, the processor 904 may be implemented in hardware, software, or a combination of hardware and software. For example, the processor 904 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), and / or an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component that can be programmed to perform a function (e.g., a field-programmable gate array (FPGA) and / or an application-specific integrated circuit (ASIC), etc.). The memory 906 may include a random access memory (RAM), a read-only memory (ROM), and / or another type of dynamic memory or static memory (e.g., flash memory, magnetic memory, and / or optical memory, etc.) that stores information and / or instructions for use by the processor 904.
[0062] The storage component 908 may store information and / or software related to the operation and use of the computing device 900. For example, the storage component 908 may include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optical disk, and / or a solid-state hard disk, etc.), 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 with a corresponding drive.
[0063] Input components 910 may include components that allow computing device 900 to receive information, for example, via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, buttons, switches, and / or a microphone, etc.). Additionally or alternatively, input components 910 may include sensors for sensing information (e.g., a Global Positioning System (GPS) component, an accelerometer, a gyroscope, and / or an actuator, etc.). Output components 912 may include components that provide output information from a computing device (e.g., a display, a speaker, and / or one or more light emitting diodes (LEDs), etc.).
[0064] The communication interface 914 may include a transceiver-like component (e.g., a transceiver, a separate receiver and a transmitter, etc.) that enables the device to communicate with other devices (e.g., via a wired connection, a wireless connection, or a combination of a wired connection and a wireless connection). The communication interface 914 may allow the computing device 900 to send information to another device and / or receive information from another device. For example, the communication interface 914 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, Interface, cellular network interface and / or Bluetooth interface, etc. In a non-limiting embodiment, the communication interface 914 operates through one or both of near field communication and radio frequency identification (RFID). Suitable communication protocols and methods for implementing communication between the communication interface 914 and the communication interface of another device (e.g., a computing device (e.g., a desktop computer, a laptop computer, a smart phone, a smart watch, a PDA, a tablet computer, etc.) may include, for example, encryption using a secure socket layer (SSL) (e.g., by using a public key / private key pair known in the art). Additional security protocols are disclosed in, for example, U.S. Patents Nos. 9,445,264 and 9,463,325, the contents of which are incorporated herein by reference in their entirety.
[0065] The computing device can perform one or more processes described herein. The computing device can be based on the processor 904 executing the software instructions stored by the computer-readable medium (such as, memory 906 and / or storage component 908) and / or being instructed by a separate computing device to perform these processes. Computer-readable media (e.g., non-transient computer-readable media) are defined as non-transient memory devices in this article. Non-transient memory devices include memory spaces located inside a single physical storage device or memory spaces distributed on multiple physical storage devices. Software instructions can be read from another computer-readable medium or from another device to the memory 906 and / or storage component 908 via the communication interface 914. The software instructions stored in the memory 906 and / or storage component 908 can make the processor 904 perform one or more processes described herein when executed. Additionally or alternatively, hard-wired circuits can be used to replace software instructions or to perform one or more processes described herein in combination with software instructions. Therefore, the embodiments described herein are not limited to any specific combination of hardware circuits and software.
[0066] Although the present invention has been described in detail based on what is currently considered to be the most practical and preferred embodiments for the purpose of illustration, it should be understood that such detail is for this purpose only and that the present invention is not limited to the disclosed embodiments, but on the contrary, the present invention is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
Claims
1. A drug delivery device, comprising: a housing including a skin-facing surface defining a cannula opening, the skin-facing surface being configured to releasably attach to the skin of a patient; a microcontroller received within the housing and comprising at least one processor; a sensor in communication with the microcontroller, the sensor being configured to detect the patient's skin; a container disposed within the housing and configured to store a pharmaceutical composition therein; as well as A sleeve is in fluid communication with the container, the sleeve being convertible from an initial position in which the sleeve is disposed within the housing to a use position in which the sleeve extends through the sleeve opening.
2. The drug delivery device according to claim 1, wherein: The sensor is a proximity sensor.
3. The drug delivery device according to claim 1, wherein: The drug delivery device is securable to a patient.
4. The drug delivery device according to claim 1, wherein: The drug delivery device is a wearable device.
5. The drug delivery device according to claim 2, wherein: The proximity sensor is a capacitive sensor, an inductive sensor and / or an ultrasonic sensor.
6. The drug delivery device according to claim 5, wherein: The sensor is an ultrasonic sensor and comprises a transmitter and a receiver.
7. The drug delivery device according to claim 1, wherein: The sensor is an optical sensor.
8. The drug delivery device according to claim 7, wherein: The optical sensor includes a transmitter and a receiver.
9. The drug delivery device of claim 1, further comprising an adhesive patch disposed between the housing and the patient's skin.
10. The drug delivery device according to claim 9, wherein: The sensor is at least partially arranged within the adhesive patch and / or on a surface of the adhesive patch.
11. The drug delivery device according to claim 10, wherein: The sensor includes a separable circuit, a strain gauge and / or a piezoelectric material.
12. The drug delivery device according to claim 9, wherein: The adhesive patch includes one or more openings therethrough, and wherein the sensor is aligned with the one or more openings.
13. The drug delivery device according to claim 12, wherein: The sensor is an optical sensor or an ultrasonic sensor.
14. The drug delivery device according to claim 13, wherein: The sensor includes a transmitter and a receiver.
15. The drug delivery device of claim 1, wherein: The sensor includes a switch.
16. The drug delivery device of claim 15, wherein: The switch is a mechanical switch.
17. A drug delivery device according to any one of claims 1 to 14, wherein: The processor is programmed or configured to: receiving data from the sensor, the data relating to whether the drug delivery device is in contact with the patient's skin; and Based on the status of the wearable drug delivery device and the data, it is determined whether the wearable drug delivery device is properly positioned on the patient's skin.
18. A drug delivery device according to any one of claims 1 to 17, wherein: The processor is programmed or configured to provide feedback indication to the patient based on at least one of proper placement and orientation of the device.
19. A drug delivery device according to any one of claims 1 to 18, wherein: The processor is programmed or configured to provide instructions to adjust or correct placement of the drug delivery device before, during, and / or after an injection.
20. The drug delivery device of claim 17, wherein: The wearable drug delivery device further includes at least one of an indicator capable of communicating a condition of the wearable drug delivery device to a user and a communication module configured to transmit data related to a state of at least one attribute of the wearable drug delivery device.
21. The drug delivery device of claim 20, wherein: At least one processor is further programmed or configured to provide an alert via the indicator and / or the communication module upon determining that the wearable drug delivery device is not properly positioned on the patient's skin.
22. The drug delivery device of claim 20, wherein: The alarm is an audible indication, a tactile indication and / or a visual indication.
23. The drug delivery device of claim 1, wherein: The container is a flexible container.
24. The drug delivery device of claim 1, wherein: The container is a syringe barrel.
25. The drug delivery device of claim 1, wherein: The device also includes a motor configured to expel the pharmaceutical composition from the container.
26. The drug delivery device of claim 15, wherein: Data received from the sensor is used to determine whether the delivery device should refrain from completing a delivery or should continue to deliver if contact with the patient is lost before a second condition is satisfied.
27. The drug delivery device of claim 26, wherein: The second condition is at least one of: delivery completion, a pressure change below a threshold indicating tissue resorption, and deployment or removal of an insertion mechanism.
Citation Information
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