Drug delivery device with skin contact sensor

Abstract

Provided herein is a wearable drug delivery device including: a housing having a skin-facing surface that defines a cannula opening, the skin-facing surface configured for releasable attachment to a patient's skin; a microcontroller received within the housing and including at least one processor; a sensor in communication with the microcontroller, the sensor configured to detect the patient's skin; a container disposed within the housing and configured to store a pharmaceutical composition therein; and a cannula in fluid communication with the container, the cannula being movable from an initial position in which the cannula is disposed within the housing to a use position in which the cannula extends through the cannula opening.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 405,099, filed September 9, 2022, entitled "Drug Delivery Device with Skin Contact Sensor," the entire disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates to wearable drug delivery devices, and in particular to wearable drug delivery devices that are capable of detecting detachment of the device from the skin of a user.

[0003] 2. Description of Related Art Medical devices such as wearable injectors, auto-injectors, and other drug delivery devices have the advantage of providing treatment to patients at locations remote from clinical facilities and / or while worn individually under the patient's clothing. Wearable medical devices can be configured to be applied to the patient's skin and automatically deliver a dose of a pharmaceutical composition within a predetermined period of time. After the device delivers the pharmaceutical composition to the patient, the patient can subsequently remove and discard the device.

[0004] In certain situations, drug delivery devices must be worn for periods ranging from minutes, hours, or days prior to drug delivery. In other situations, injections are administered over longer periods or with multiple consecutive injections (e.g., insulin, Alzheimer's disease medication, Parkinson's disease medication, chemotherapy, etc.). In these situations, soft catheters may be used. However, removal of the device (partial, complete, temporary, and / or permanent) can lead to catheter migration outside the target injection site, causing failure. Furthermore, this failure may be silent and may go unnoticed by the patient. Therefore, there is a need in the art for robust sensors and alerts for use in wearable drug delivery devices. Summary of the Invention

[0005] Provided herein is a wearable drug delivery device including: a housing including a skin-facing surface that defines a cannula opening, the skin-facing surface configured for releasable attachment to a patient's skin; a microcontroller received within the housing and including at least one processor; a sensor in communication with the microcontroller, the sensor configured to detect the patient's skin; a container disposed within the housing and configured to store a pharmaceutical composition therein; and a cannula in fluid communication with the container, the cannula being movable from an initial position in which the cannula is disposed within the housing to a use position in which the cannula extends through the cannula opening.

[0006] In one embodiment, the sensor is a proximity sensor.

[0007] In one embodiment, the drug delivery device is securable to the patient.

[0008] In one embodiment, the drug delivery device is a wearable device.

[0009] In one embodiment, the proximity sensor is a capacitive sensor, an inductive sensor, and / or an ultrasonic sensor.

[0010] In one embodiment, the sensor is an ultrasonic sensor and includes an emitter and a receiver.

[0011] In one embodiment, the sensor is an optical sensor.

[0012] In one embodiment, the optical sensor includes an emitter and a receiver.

[0013] In one embodiment, the drug delivery device further comprises an adhesive patch disposed between the housing and the patient's skin.

[0014] In one embodiment, the sensor is disposed at least partially in and / or on the surface of the adhesive patch.

[0015] In one embodiment, the sensor includes a separable electrical circuit, a strain gauge, and / or a piezoelectric material.

[0016] In one embodiment, the adhesive patch includes one or more openings therethrough, and the sensor is aligned with the one or more openings.

[0017] In one embodiment, the sensor is an optical sensor or an ultrasonic sensor.

[0018] In one embodiment, the sensor includes an emitter and a receiver.

[0019] In one embodiment, the sensor includes a switch.

[0020] In one embodiment, the switch is a mechanical switch.

[0021] In one embodiment, the processor is programmed or configured to receive data from the sensor regarding whether the drug delivery device is in contact with the patient's skin and determine whether the wearable drug delivery device is properly positioned on the patient's skin based on the status of the wearable drug delivery device and the data.

[0022] In one embodiment, the processor is programmed or configured to provide a feedback indication to the patient based on at least one of correct placement and orientation of the device.

[0023] In one embodiment, the processor is programmed or configured to provide instructions for adjusting or modifying the positioning of the drug delivery device before, during, and / or after injection.

[0024] In one embodiment, the wearable drug delivery device further includes at least one of an indicator capable of communicating the status of the wearable drug delivery device to the user and a communication module configured to transmit data related to the status of at least one characteristic of the wearable drug delivery device.

[0025] In one embodiment, the at least one processor is further programmed or configured to provide an alert via the indicator and / or communication module upon determining that the wearable drug delivery device is not properly positioned on the patient's skin.

[0026] In one embodiment, the alert is an audible, tactile, and / or visual indication.

[0027] In one embodiment, the container is a flexible container.

[0028] In one embodiment, the container is a syringe barrel.

[0029] In one embodiment, the device further comprises a motor configured to expel the pharmaceutical composition from the container.

[0030] In one embodiment, the data received from the sensor is used to determine whether the delivery device should avoid completion or pursue delivery if contact with the patient is interrupted before the second condition is met.

[0031] In one embodiment, the second condition is at least one of complete delivery, a pressure change below a threshold indicative of tissue resorption, and deployment or removal of the insertion mechanism. [Brief explanation of the drawings]

[0032] [Figure 1] 1 is a perspective view of a medication delivery device according to one aspect or embodiment of the present application; [Figure 2] FIG. 2 is a perspective view of the drug delivery device of FIG. 1 with the top cover removed. [Figure 3] FIG. 2 is a schematic diagram of the drug delivery device of FIG. 1. [Figure 4] FIG. 2 is a schematic diagram of the drug delivery device of FIG. 1. [Figure 5] FIG. 2 is a schematic diagram of the drug delivery device of FIG. 1. [Figure 6] FIG. 2 is a schematic diagram of the drug delivery device of FIG. 1. [Figure 7] FIG. 1 illustrates a non-limiting embodiment or aspect of an environment in which the systems, devices, and / or methods described herein may be implemented. [Figure 8] 8 is a diagram of a non-limiting embodiment or aspect of components of one or more devices of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION

[0033] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0034] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the invention as oriented in the drawings. It will be understood, however, that the invention may assume various alternative modifications unless expressly specified to the contrary. It will also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are simply exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0035] All numbers used in this specification and claims should be understood as being modified in all instances by the term "about," by which is meant a range of plus or minus ten percent of the stated value. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The terms "first," "second," etc. are not intended to refer to any particular order or chronology, but instead refer to different states, properties, or elements. "At least" means "greater than or equal to."

[0036] As used herein, the term "cannula" may refer to needles, cannulas, catheters, and similar structures that allow fluid communication between a container of a pharmaceutical composition and a patient.

[0037] As used herein, the term patient may refer to a human or non-human animal.

[0038] As used herein, the terms “communication” and “communicating” refer to the receipt or transfer of one or more signals, messages, commands, or other types of data. For one unit (e.g., any device, system, or component thereof) to communicate with another unit means that the unit can receive data from and / or transmit data to the other unit, directly or indirectly. This may refer to a direct or indirect connection that is wired and / or wireless in nature. Furthermore, two units may communicate with each other even if the transmitted data is modified, processed, relayed, and / or routed between the first and second units. For example, a first unit may communicate with a second unit even if the first unit passively receives data and does not actively transmit data to the second unit. As another example, a first unit may communicate with a second unit if an intermediate unit processes data from the one unit and transmits the processed data to the second unit. It will be appreciated that many other arrangements are possible. Any known electronic communication protocol and / or algorithm may be used, such as TCP / IP (including HTTP and other protocols), WLAN (including 802.11a / b / g / n and other radio frequency-based protocols and methods), analog transmission, Global System for Mobile Communications (GSM), 3G / 4G / LTE, Bluetooth, ZigBee, EnOcean, TransferJet, Wireless USB, and the like 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 and / or the like) containing data.

[0039] As used herein, the term "computing device" may refer to one or more electronic devices configured to process data. A computing device, in some examples, may include components necessary 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. By way of example, a mobile device may include a mobile phone (e.g., a smartphone or a standard mobile phone), a portable computer, a wearable device (e.g., a watch, glasses, lenses, clothing, and / or the like), a personal digital assistant (PDA), and / or other similar devices. A computing device may also be a desktop computer or other form of non-mobile computer.

[0040] 1 and 2, drug delivery device 10 includes a reservoir, an insertion mechanism 16, control electronics 18, a cover 20, and a base 22. In a non-limiting embodiment, drug delivery device 10 is a wearable auto-injector, such as an insulin or bone marrow stimulating agent delivery device. Drug delivery device 10 can be attached to a patient's skin and activated to inject a pharmaceutical composition from reservoir 12 into the patient. Drug delivery device 10 can be pre-filled with the pharmaceutical composition, or drug delivery device 10 can be filled with the pharmaceutical composition by the patient or a medical professional prior to use.

[0041] The drug delivery device 10 is configured to deliver a pharmaceutical composition, e.g., a dose of any desired drug, into a patient's body via subcutaneous injection at a slow and controlled injection rate. An exemplary duration of delivery achieved by the drug delivery device 10 can range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the pharmaceutical composition delivered by the drug delivery device 10 can range from about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The amount of pharmaceutical composition delivered to a patient can be adjusted.

[0042] 3-5, the drug delivery device 10 may further include an adhesive patch 70 for securing the drug delivery device 10 to a patient's skin 80, and may further 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 described herein (and shown, e.g., in FIG. 9), e.g., one or more processors, and optionally, memory storing programming instructions for providing, e.g., the functionality described below. FIGS. 3-5 illustrate non-limiting embodiments of sensors that may be useful for detecting whether the drug delivery device 10 is in proximity to (e.g., attached to) a patient's skin. While sensors including capacitive and / or inductive sensors ( FIG. 3 ), optical and / or ultrasonic sensors ( FIG. 4 ), and separable electrical circuits, strain gauges, and / or piezoelectric materials ( FIG. 5 ) are illustrated, one skilled in the art will understand that other sensors, including switches, such as mechanical switches, may be used to determine proximity to a patient's skin. For example, the mechanical switch may be biased to the first configuration, e.g., 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 be held against a biasing force in the second configuration. Upon partial and / or complete detachment or dislodgment from the skin 80, the switch may transition partially or fully to the first configuration, which may be detected by the microcontroller 24, which may alert the patient to the condition, as described herein. In non-limiting embodiments, the drug delivery device may include any type, number, and arrangement of sensors 26 described herein.

[0043] 3, a non-limiting embodiment is shown in which sensor 26 is a proximity sensor, such as a capacitive and / or inductive sensor, capable of detecting changes in the environment surrounding the sensor based on changes in the electric and / or magnetic fields generated by different materials (e.g., air vs. skin) present in the vicinity of the sensor. The detected field changes, when processed by microcontroller 24, can determine whether drug delivery device 10 has been moved relative to the patient's skin 80 such that cannula 48 has not reached or can reach the proper injection depth. Suitable capacitive and inductive sensors are known to those skilled in the art and are commercially available.

[0044] With reference to FIG. 4 , a non-limiting embodiment is shown in which the sensor 26 is an optical and / or ultrasonic sensor. In a non-limiting embodiment, the optical and / or ultrasonic sensor 26 includes an emitter 26 a and a detector 26 b, which may be in the same sensor unit or different sensor units. In a non-limiting embodiment, the emitter 26 a is a light-emitting diode (LED), and the detector 26 b is a photodiode. In a non-limiting embodiment, the adhesive patch 70 includes one or more openings therethrough, and the sensor 26 (and / or components thereof, such as the emitter 26 a and / or the detector 26 b) may, in some embodiments, be aligned with the one or more openings such that there is no adhesive pad between the sensor 26 and the patient's skin 80. As noted above, a change in the detected signal (e.g., ultrasonic or optical), when processed by the microcontroller 24, may determine whether the drug delivery device 10 has been moved relative to the patient's skin 80, such that the cannula 48 has not reached or is unable to reach the proper injection depth.

[0045] 5, a non-limiting embodiment is shown in which the sensor 26 is at least partially integrated into the adhesive patch 70, e.g., via a separable electrical circuit, a strain gauge, and / or a piezoelectric material. By "integrated," it is contemplated that the sensor may be at least partially received within and / or on the surface of the adhesive patch 70. The adhesive patch 70 may have one or more openings 72, as described above, to correspond, for example, to pre-cut or cuttable portions of the patch 70. Such openings 72 may distinguish between sections of the patch 70 that are heat-staken to the base of the drug delivery device 10 and those sections that are not. Such a sensor may detect a change in the orientation of the drug delivery device 10 relative to the patient's skin 80, for example, based on deformation of the adhesive patch 70, which may include one or more portions of the sensor 26. As described above, changes in the detected signal (e.g., interruption of the electrical circuit, strain amplitude, and / or piezoelectric signal), when processed by the microcontroller 24, may determine whether the drug delivery device 10 has been moved relative to the patient's skin 80 such that the cannula 48 has not reached or is unable to reach the proper injection depth.

[0046] In non-limiting embodiments of the drug delivery device 10 described herein, the microcontroller 24 in communication with the sensor 26 may be programmed or configured to compare signals received from the sensor 26 to appropriate reference values ​​corresponding to the type of sensor 26 included in the drug delivery device 10 to determine whether the drug delivery device 10 is properly placed on the patient's skin 80. In non-limiting embodiments, upon determining that the drug delivery device 10 is not properly placed on the patient's skin 80, an alert may be transmitted via any visual, audible, and / or tactile means by the microcontroller 24 in communication with an appropriate type of indicating device (e.g., a light source such as an LED, a speaker, and / or a device that generates a tactile indication). In non-limiting embodiments, the microcontroller 24 may also store data related to the placement of the drug delivery device 10 in memory to provide a history for later review and / or comparison.

[0047] Referring to FIG. 6, a schematic diagram of possible components of a 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, although one 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, including a computing device (e.g., a microcontroller 24) that controls the operation of the drug delivery device 10, a sensor 26, a pump and valve controller 28, sensing electronics 30, and deployment electronics 32. The drug delivery device 10 includes a fluidics subsystem, including a reservoir 12, a volume sensor 34 for the reservoir 12, a reservoir fill port 36, and a metering system 38, including a pump and valve actuator 40 and a pump and valve mechanism 42. One skilled in the art will understand that any suitable container may be used in the context of the present invention. For example, while FIG. 6 references a syringe having a fill port 36 and a reservoir 12, other suitable containers, such as flexible containers, may also be used in the present invention. The fluidic subsystem may further 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 disposed entirely 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 described in U.S. Pat. No. 10,449,292, the entirety of which is incorporated herein by reference.

[0048] 7, a 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 including a microcontroller 704 and one or more sensors as described herein, a computing device such as 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., establish a connection to communicate) via a wired connection, a wireless connection, or a combination of wired and wireless connections.

[0049] Drug delivery device 702, which may be a wearable drug delivery device as described herein, may include one or more sensors in communication with microcontroller 704, as described above, which may also include a communication interface for transmitting and / or receiving data from user device 706. One or both of microcontroller 704 and user device 706 may be a computing device as described herein, including any components described herein and / or illustrated in FIG. 8 described below.

[0050] The communication network 708 may include one or more wired and / or wireless networks. For example, the communication network 708 may include a Bluetooth connection (e.g., 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) and / or the like), a private network, an ad hoc network, an intranet, the Internet, an optical fiber-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.

[0051] User device 706, in some non-limiting embodiments, may be a computing device as described herein, a smartphone, a smartwatch, a tablet, a laptop computer, a desktop computer, or other computing device. User device 706 may be programmed or configured to communicate with other systems, such as healthcare systems associated with pharmaceutical manufacturers, device manufacturers, clinical trial sponsors, and / or physicians, for example, via a communications network 708, for example, via applications, such as mobile applications, executable on user device 706.

[0052] Referring to Figure 8, a diagram of example components of an example computing device useful in the devices, systems, and methods described herein is shown. Such a computing device 900 may correspond, for example, to components within a drug delivery device as described herein and / or a user device such as a mobile phone, tablet, laptop computer, smart watch, or other personal communication device, as shown in example environment 700 of Figure 7. As shown in Figure 9, computing device 900 may include a bus 902, a processor 904, memory 906, storage components 908, input components 910, output components 912, and / or a communication interface 914.

[0053] The bus 902 may include components that enable communication between 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), 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 functions. The memory 906 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 the processor 904.

[0054] 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, a solid-state disk, and / or the like), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium, along with a corresponding drive.

[0055] Input components 910 may include components that enable computing device 900 to receive information, such as via user input (e.g., a touchscreen display, a keyboard, a keypad, a mouse, buttons, switches, a microphone, and / or the like). Additionally or alternatively, input components 910 may include sensors for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, and the like). Output components 912 may include components that provide output information from the computing device (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), and / or the like).

[0056] The communication interface 914 may include transceiver-like components (e.g., a walkie-talkie, a separate receiver and transmitter, etc.) that enable the device to communicate with other devices, for example, via a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication interface 914 may enable the computing device 900 to send 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, a Wi-Fi interface, a cellular network interface, a Bluetooth interface, and / or the like. In a non-limiting embodiment, the communication interface 914 operates via one or both of near field communication and RFID. Suitable communication protocols and methods for securing communications between communication interface 914 and a communication interface of another device, such as a computing device (e.g., a desktop computer, a laptop computer, a smartphone, a smartwatch, a PDA, a tablet, etc.), may include encryption (e.g., using public / private key pairs, as known in the art) using, for example, Secure Sockets Layer (SSL). Additional security protocols are disclosed, for example, in U.S. Patent Nos. 9,445,264 and 9,463,325, the contents of which are incorporated herein by reference in their entireties.

[0057] The computing device may perform one or more processes described herein. The computing device may perform these processes based on the processor 904 executing software instructions stored by a computer-readable medium, such as the memory 906 and / or the storage component 908, 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 may include memory space located within a single physical storage device or memory space spread across multiple physical storage devices. Software instructions may be loaded into the memory 906 and / or the storage component 908 from another computer-readable medium or from another device via the communication interface 914. When executed, the software instructions stored in the memory 906 and / or the storage component 908 may cause the processor 904 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, the embodiments described herein are not limited to any specific combination of hardware circuitry and software.

[0058] While the present invention has been described in detail for purposes of illustration, based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for this purpose only, and the invention is not limited to the disclosed embodiments, but rather 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 housing comprising a skin-facing surface defining a cannula opening, wherein the skin-facing surface is configured to be releasably attached to the patient's skin, A microcontroller, which includes at least one processor, is housed within the aforementioned housing. A sensor that communicates with the microcontroller and is configured to detect the patient's skin, A container placed within the housing and configured to store a pharmaceutical composition therein, A cannula that flows with the container, wherein the cannula is transitionable from an initial position in which it is positioned within the housing to a position in which it extends through the cannula opening. Drug delivery devices, including those mentioned above.

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 fixable.

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 includes an emitter 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, comprising an emitter and a receiver for the optical sensor.

9. The drug delivery device according to 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 disposed within and / or on the surface of the adhesive patch.

11. The drug delivery device according to claim 10, wherein the sensor comprises a separable electrical 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 through which 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 comprises an emitter and a receiver.

15. The drug delivery device according to claim 1, wherein the sensor includes a switch.

16. The drug delivery device according to claim 15, wherein the switch is a mechanical switch.

17. The aforementioned processor, The sensor receives data relating to whether the drug delivery device comes into contact with the patient's skin. The drug delivery device according to claim 4, further programmed or configured to determine whether the wearable drug delivery device is properly positioned on the patient's skin based on the status of the wearable drug delivery device and the data.

18. The drug delivery device according to claim 1, wherein the processor is programmed or configured to provide feedback to the patient based on at least one of the correct placement and orientation of the drug delivery device.

19. The drug delivery device according to claim 1, wherein the processor is programmed or configured to provide instructions for adjusting or modifying the placement of the drug delivery device before, during, and / or after injection.

20. The drug delivery device according to claim 17, further comprising at least one of an indicator capable of informing a user of the status of the wearable drug delivery device, and a communication module configured to transmit data relating to the status of at least one characteristic of the wearable drug delivery device.

21. The drug delivery device according to claim 20, further programmed or configured to provide an alert via the indicator and / or the communication module when at least one processor determines that the wearable drug delivery device is not properly positioned on the patient's skin.

22. The drug delivery device according to claim 21, wherein the alert is an audible, tactile, and / or visual indication.

23. The drug delivery device according to claim 1, wherein the container is a flexible container.

24. The drug delivery device according to claim 1, wherein the container is a syringe barrel.

25. The drug delivery device according to claim 1, further comprising a motor configured to discharge the pharmaceutical composition from the container.

26. The drug delivery device according to claim 15, wherein data received from the sensor is used to determine whether the drug delivery device should avoid completion or pursue delivery if contact with the patient is interrupted before a second condition is met.

27. The drug delivery device according to claim 26, wherein the second state is at least one of completion of delivery, a pressure change below a threshold indicating tissue absorption, and deployment or removal of the insertion mechanism.

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