Patent Description:
The present invention relates generally to wearable injection and/or infusion devices, and in particular, to wearable injection and/or infusion devices for administrating a therapeutic agent to a patient.

Various types of automatic injection devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by untrained personnel or to be self-injected. Generally, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation, and some type of automatic needle-injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as <NUM>, an auto-injector is typically used, which typically has an injection time of about <NUM> to <NUM> seconds. When the volume of fluid or drug to be administered is above <NUM>, the injection time generally becomes longer resulting in difficulties for the patient to maintain contact between the device and the target area of the patient's skin. Further, as the volume of drug to be administered becomes larger, increasing the time period for injection becomes desirable. The traditional method for a drug to be injected slowly into a patient is to initiate an IV and inject the drug into the patient's body slowly. Such a procedure is typically performed in a hospital or outpatient setting.

Certain devices allow for self-injection or self-infusion in a home setting and are capable of gradually injecting a liquid therapeutic preparation into the skin of a patient. In some cases, these devices are small enough (both in height and in overall size) to allow them to be "worn" by a patient while the liquid therapeutic preparation is being infused into the patient. These wearable injection and/or infusion devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic preparation to flow out of a reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism to cause the liquid therapeutic preparation to begin to flow at the proper time and a triggering mechanism to initiate the injection.

While various wearable injection and/or infusion devices exist in the art, there is a need in the art for an improved wearable injection and/or infusion device.

Document <CIT> discloses a delivery device with a housing, a drive mechanism and a detection module. Documents <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT> also disclose delivery devices.

Generally, provided is an improved wearable injection and/or infusion device configured for administrating a therapeutic agent to a patient. In some examples, the wearable injection and/or infusion device may be configured for continuous monitoring of dose progression. In other examples, the wearable injection and/or infusion device may be configured for detecting a stall in dose progression based on a detected delivery rate. In further examples, the wearable injection and/or infusion device may be configured for detecting a temperature of the therapeutic agent and adjusting at least one dose progression protocol based on a detected temperature. In other examples, the wearable injection and/or infusion device may be configured to enable external communication of data to a remote device. In further examples, the wearable injection and/or infusion device may incorporate enhanced visual indicators about a status of the device.

In some examples of the present disclosure, a delivery device for delivering a medical fluid to a patient may have a housing configured for receiving a container at least partially filled with the medical fluid. The delivery device further may have a drive mechanism associated with the housing configured for delivering the medical fluid from the container to the patient in a dosing procedure. The delivery device further may have a module configured for detecting at least one of a property of the dosing procedure and a property of the medical fluid. The module may have at least one dose detection sensor configured for detecting an initiation, progression, and completion of the dosing procedure based on a position of a stopper within the container. The module further may have at least one temperature sensor configured for measuring a temperature of the medical fluid within the container based on a temperature of the container.

In other examples of the present disclosure, the at least one dose detection sensor may be configured for measuring a rate of delivery of the medical fluid to the patient based on detecting a change in the position of the stopper as a function of time. The module may be configured to stop the drive mechanism if the rate of delivery of the medical fluid measured by the at least one dose detection sensor is below a minimum threshold or above a maximum threshold. An output of the at least one dose detection sensor may be a function of an output of at least one temperature sensor. The at least one dose detection sensor may be an optical sensor array configured to detect an actual volume of the medical fluid in the container or estimate a volume of the medical fluid in the container based on the position of the stopper within the container. The optical sensor array may have one or more infrared emitters configured to emit electromagnetic energy in an infrared spectrum and one or more infrared detectors configured to detect electromagnetic energy in the infrared spectrum.

In other examples of the present disclosure, the temperature of the medical fluid may be a function of an ambient environment temperature outside the housing of the delivery device and a local temperature within the housing of the delivery device. The module may be configured to prevent actuation of the drive mechanism if a temperature of the medical fluid within the container is below a minimum threshold or above a maximum threshold.

In other examples of the present disclosure, the module further may have at least one activation detection switch configured for detecting the initiation of the dosing procedure and at least one completion detection switch configured for detecting the completion of the dosing procedure. The at least one activation detection switch may be configured to detect at least one of a position and a velocity of at least one component of the drive mechanism and the at least one completion detection switch may be configured to detect at least one of a position and a velocity of at least one component of the drive mechanism. The at least one activation detection switch may be a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor without direct physical contact with at least one component of the drive mechanism. The at least one completion detection switch may be a mechanical sensor in direct physical contact with at least one component of the drive mechanism or an optical sensor without direct physical contact with at least one component of the drive mechanism.

In other examples of the present disclosure, the module further may have a communication element configured for external communication with a remote device via a wired connection, a wireless connection, or a combination of the wired connection and the wireless connection. The communication element may be a one-way communication element configured to send information to the remote device or receive information from the remote device, or a two-way communication element configured to send information to the remote device and receive information from the remote device. The remote device may be configured to provide at least one of contextual instructions for using the delivery device, safety protocol information about the dosing procedure, and a status indication of at least one stage of the dosing procedure.

In other examples of the present disclosure, the module further may have one or more indicators configured for providing at least one of information about a state of the dosing procedure and operation instructions to a user. The one or more indicators may have at least one visual indicator having at least one light, the at least one light is a single or multi-color light-emitting diode configured for at least one of steady state and flashing operation. The one or more indicators may have at least one audible indicator configured for delivering an audible message to a user. The delivery device may have a cover removably connectable to the housing, wherein the module is connected to the cover.

As used herein, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

Spatial or directional terms, such as "left", "right", "inner", "outer", "above", "below", and the like, relate to the invention as shown in the drawing figures and are not to be considered as limiting as the invention can assume various alternative orientations.

All numbers and ranges used in the specification and claims are to be understood as being modified in all instances by the term "about". By "about" is meant plus or minus twenty-five percent of the stated value, such as plus or minus ten percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of "<NUM> to <NUM>" should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of <NUM> and the maximum value of <NUM>; that is, all subranges or subratios beginning with a minimum value of <NUM> or more and ending with a maximum value of <NUM> or less. The ranges and/or ratios disclosed herein represent the average values over the specified range and/or ratio.

The terms "first", "second", and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

The term "at least" is synonymous with "greater than or equal to".

The term "not greater than" is synonymous with "less than or equal to".

As used herein, "at least one of" is synonymous with "one or more of'. For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

The discussion of the invention may describe certain features as being "particularly" or "preferably" within certain limitations (e.g., "preferably", "more preferably", or "even more preferably", within certain limitations). It is to be understood that the invention is not limited to these particular or preferred limitations but encompasses the entire scope of the disclosure.

In various non-limiting examples or aspects, and with reference to <FIG>, the present disclosure is directed to a wearable injection and/or infusion device that may be configured for continuous monitoring of dose progression. In other examples, the wearable injection and/or infusion device may be configured for detecting a stall in dose progression based on a detected delivery rate. In further examples, the wearable injection and/or infusion device may be configured for detecting a temperature of the therapeutic agent and adjusting at least one dose progression protocol based on the detected temperature. In other examples, the wearable injection and/or infusion device may be configured to enable external communication of data to a remote device. In further examples, the wearable injection and/or infusion device may incorporate enhanced visual indicators about a status of the device.

With reference to <FIG>, a wearable injection and/or infusion device <NUM> is shown in accordance with one example. The wearable injection and/or infusion device <NUM> is configured for being connected to the skin of a patient to deliver a dose of a therapeutically effective amount of a therapeutic agent at a predetermined delivery rate. For example, the therapeutic agent may be any type of drug, chemical, biological, or biochemical substance that, when delivered in a therapeutically effective amount, achieves a desired therapeutic effect. The wearable injection and/or infusion device <NUM> has a housing <NUM> for enclosing a syringe assembly <NUM> (shown in <FIG>) that is in fluid communication with a container <NUM> (shown in <FIG>) filled with the therapeutic agent. The wearable injection and/or infusion device <NUM> is operable to deliver the therapeutic agent from the container <NUM> to the patient using the syringe assembly <NUM>.

With reference to <FIG>, the housing <NUM> of the wearable injection and/or infusion device <NUM> has a cover <NUM> that may be removably connected to the housing. The cover <NUM> may have a module <NUM> (shown in <FIG>) comprising a plurality of components configured for dose progression, stall detection, temperature measurement, and external communication. As discussed herein, the module <NUM> may include one or more sensors, such as environmental sensors (e.g. temperature), to both improve the dose detection algorithms (e.g. fluid viscosity temperature effects) and to provide feedback to the user (e.g. drug is too cold for injection). The module <NUM> may additionally include one or more indicators (e.g. audible, visible, tactile) to provide feedback or instruction to the user. The module <NUM> may also include communication capabilities to transmit device data to an external device (e.g. a smartphone). The module <NUM> is integrated with the cover <NUM> such that, when the cover <NUM> is connected to the housing <NUM>, the module <NUM> does not interfere with the underlying function of the wearable injection and/or infusion device <NUM>. The module <NUM> may include additional sensors to detect mechanical motions associated with injector operation (e.g. switches to detect activation, completion, needle insertion/withdrawal, or other device events and states). The module <NUM> may have one or more additional sensors to continuously monitor dose delivery, such as an optical sensor array, capacitive sensor array, inductive sensor array, etc..

In some examples, the cover <NUM>, including the module <NUM> may be provided as a replacement to an existing cover of an existing wearable injection and/or infusion device (not shown). In such examples, the cover <NUM> and the module <NUM> may be integrated with the wearable injection and/or infusion device to provide additional functionality to the wearable injection and/or infusion device afforded by the module <NUM>. For example, the cover <NUM> may be used with the wearable injection and/or infusion device disclosed in International Patent Application No. <CIT> (published as <CIT>).

The cover <NUM> has a viewing window <NUM> for viewing the contents of the container <NUM>, such as viewing a fill volume of the container <NUM>. A filter (not shown) may be provided on the viewing window <NUM> for filtering the ambient light passing through the window <NUM>. The housing <NUM> further has an indicator <NUM> for indicating a status of the wearable injection and/or infusion device <NUM>.

With reference to <FIG>, the wearable injection and/or infusion device <NUM> further has an activation detection switch <NUM> and a completion detection switch <NUM> for detecting an activation/completion of a dosing procedure. The wearable injection and/or infusion device <NUM> further has an activation detection button switch <NUM> to detect the state of an injector activation button <NUM> (shown in <FIG>). The wearable injection and/or infusion device <NUM> further has a wireless communication element <NUM> for communication with a remote device, an on/off switch <NUM> for powering the device <NUM> on/off, and a charging port <NUM> for recharging a battery <NUM>. The wearable injection and/or infusion device <NUM> further has an audible indicator <NUM>, one or more temperature sensors <NUM>, and a dose detection array <NUM>.

With reference to <FIG>, a controller <NUM> may be provided for controlling one or more of the components of the wearable injection and/or infusion device <NUM>. In some examples, the controller <NUM> includes a processor <NUM>, memory <NUM>, storage component <NUM>, and a bus <NUM> for communicating with various components of the wearable injection and/or infusion device <NUM>. The bus <NUM> includes a component that permits communication among the components of the wearable injection and/or infusion device <NUM>. In some non-limiting embodiments, processor <NUM> is implemented in hardware, firmware, or a combination of hardware and software. For example, the processor <NUM> includes a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), 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), etc.) that can be programmed to perform a function. Memory <NUM> includes a random access memory (RAM), a read only memory (ROM), and/or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and/or instructions for use by the processor <NUM>.

Storage component <NUM> stores information and/or software related to the operation and use of the wearable injection and/or infusion device <NUM>. For example, the storage component <NUM> includes a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optic disk, a solid state disk, etc.), a cartridge, a magnetic tape, and/or another type of computer-readable medium, along with a corresponding drive. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A memory device includes memory space located inside of a single physical storage device or memory space spread across multiple physical storage devices.

The wearable injection and/or infusion device <NUM> can perform one or more processes described herein. The wearable injection and/or infusion device <NUM> can perform these processes based on the processor <NUM> executing software instructions stored by a computer-readable medium, such as the memory <NUM> and/or storage component <NUM>. Software instructions can be read into the memory <NUM> and/or the storage component <NUM> from another computer-readable medium or from another device via the bus <NUM>. When executed, software instructions stored in the memory <NUM> and/or the storage component <NUM> cause the processor <NUM> to perform one or more processes described herein. Additionally, or alternatively, hardwired circuitry can be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, examples described herein are not limited to any specific combination of hardware circuitry and software.

In some non-limiting examples, the controller <NUM> includes additional components, fewer components, different components, or differently arranged components than those shown in <FIG>. Additionally, or alternatively, a set of components (e.g., one or more components) of the controller <NUM> can perform one or more functions described as being performed by another set of components of the wearable injection and/or infusion device <NUM>.

In some examples, the cover <NUM> and the module <NUM> may be configured to track the mechanical state of the underlying components of the wearable injection and/or infusion device <NUM>. For example, detection switches <NUM>, <NUM> within the module <NUM> may be configured to detect at least one characteristic of at least one component of the wearable injection and/or infusion device <NUM>, such as a position, velocity, and/or changes in state of a component from a first state to a second state. For example, detection switches <NUM>, <NUM> within the module <NUM> may be configured to detect the mechanical motions associated with changes in injector state, such as needle shield removal, injector unlock, activation button depression, injection activation, and injection completion. In some examples, the detection switches <NUM>, <NUM> may be mechanical components, with direct mechanical interactions with the underlying components. In other examples, the detection switches <NUM>, <NUM> may be infrared-based optical sensors (e.g. reflectance or photointerrupter sensors) to allow non-contact detection. Transitions in device state may be used as triggers to start or stop other system measurements such as temperature or dose progression.

In some examples, the wearable injection and/or infusion device <NUM> may be configured to monitor dose progression and detect stalling of dose progression using the module <NUM>. For example, the dose detection array <NUM> of the module <NUM> may be an optical sensor array for tracking a dispense chain. The dose detection array <NUM> may be configured to detect, or estimate using an algorithm, a volume of therapeutic agent that is delivered to the patient. The dose detection array <NUM> may be configured so as to not contact the components of the wearable injection and/or infusion device, and therefore not impact the delivery of the therapeutic agent. For example, the dose detection array <NUM> may be positioned on a lateral side of the container <NUM>. The dose detection array <NUM> may be configured for detecting a progression of a stopper in a longitudinal direction of the container <NUM> and correlate the position of the stopper with a volume of the therapeutic agent that has been delivered and/or a volume of the volume of the therapeutic agent remaining in the container <NUM>. In some examples, the dose detection array <NUM> may be an optical system having one or more emitters that emit electromagnetic energy, such as visible or infrared light, that is reflected from the stopper and the container <NUM> to be received by one or more detectors. The reflective nature of the dose detection array <NUM> allows for the components to be placed on one side of the container <NUM>. This makes a more compact and easier to manufacture system than an arrangement where emitters and detectors are positioned opposite one another.

In some examples, such as shown in <FIG>, the dose detection array <NUM> may be an infrared-based optical sensor array comprising one or more infrared emitters <NUM> (e.g. IR LEDs, and phototransistors or photodiodes) configured to emit electromagnetic energy in an infrared spectrum and one or more infrared detectors <NUM> configured to detect electromagnetic energy in the infrared spectrum. The dose detection array <NUM> may be integrated with the cover <NUM> such that removal of the cover <NUM> from the housing <NUM> also removes the dose detection array <NUM> from the housing <NUM>.

With continued reference to <FIG>, emitters <NUM> and detectors <NUM> may be interleaved on a common circuit board. The number of emitters <NUM> may be the same or different from the number of detectors <NUM>. In some examples, emitters <NUM> and detectors <NUM> may be arranged in an alternating pattern, where each emitter/detector is positioned between a pair of detectors/emitters. The dose detection array <NUM> may be in electronic communication with a controller for controlling the optical components and processing the detector output to establish a location of the stopper. The wearable injection and/or infusion device <NUM> may further have other electronic devices to connect the controller to the dose detection array <NUM> (e.g. multiplexers, amplifiers, A/D, etc). The infrared spectrum offers improved immunity to external noise sources, such as visible light sources. Infrared light emitted from the emitters is also not visible to the user.

In use, a single emitter <NUM> may be activated to emit infrared light, while one or more detectors <NUM> detect the infrared light reflected from the container <NUM>. This sequence can be repeated iteratively between different emitter/detector combinations. The sampling of all detectors <NUM> may be done simultaneously, or in a sequential manner. In some examples, emitters <NUM> may be active for less than <NUM> per measurement (<NUM>% duty cycle). The detector measurements are compared against a pre-existing set of reference measurements, and matched to the most likely reference point, which correlates to a stopper/plunger position. The number of reference measurement points may be higher than the number of detectors <NUM>, in order to improve position resolution (e.g. <NUM> reference points using <NUM> detectors). In this manner, the dose detection array <NUM> functions similar to a multi-step encoder, such as a <NUM>-step absolute position encoder. The method to match the acquired values to the reference minimizes the error between the collected data and the reference. Weighting methods may be used to selectively favor certain emitter/detector combinations at different times or positions during injection. Additional filtering may be employed to preprocess the data, such as to minimize ambient light effects. In some examples, the dose detection array <NUM> may have ~<NUM> step resolution. To minimize effects of ambient infrared energy, a number of background measurements may be taken when no emitters are energized, so as to establish a detector baseline. This baseline value may then be subtracted from the detector measurements when an emitter is energized. Synchronous modulation techniques may also be utilized to isolate the target measurement from background energy levels.

In some examples, signal measurements may be processed using feature recognition methods to identify known signal features (e.g. local maxima or minima) which correspond to specific stopper/plunger positions, thus alleviating or minimizing the reliance on a pre-existing set of reference measurements. Feature recognition methods can include fuzzy logic and machine learning based techniques.

The determination of dose progression may be founded on a position-based algorithm, from which a volume of the delivered dose can be calculated. The change in position of the stopper as a function of time can be used to calculate the velocity of the stopper, and therefore a rate of delivery of the therapeutic agent. The algorithm can compensate for known variations in the fluid delivery components, such as variability in the diameter and length of the container <NUM>. Velocity data of the stopper/plunger can be used to determine whether the dosing procedure is stalled. For example, a minimum threshold (stall condition) may correspond with a minimum stopper/plunger velocity combined with any error sources (noise, ambient IR, etc.). For example, stall detection time may be dictated by a slowest acceptable delivery rate, such as <NUM>µl/s. <FIG> show various performance parameters as a function of time.

As optical components are known to be temperature sensitive, temperature compensation may be applied using measurements from temperature sensors, to continuously correct for temperature-related measurement errors. With reference to <FIG>, input from one or more temperature sensors may be passed through one or more filters to compensate for any temperature-related measurement errors.

In injection systems where the container <NUM> must first translate a fixed distance to pierce the septum, the dose detection array can also be used to detect the position of the entire container <NUM> (including plunger). A separate reference measurement set can be utilized to determine the position of the entire container <NUM>. Once the container is detected to be in the pierced state, the algorithm can switch to the reference set used to detect plunger position.

In some examples, computed position and velocity data can be used to determine whether the device was prematurely removed from the injection site. For example, a maximum velocity threshold may correspond to the maximum expected stopper/plunger velocity when injected into a body (i.e. a high pressure site). Velocities higher than this threshold may correspond to injection in air (i.e. a low pressure site). A large, sudden unexpected change in position or velocity, can thus be used to indicate an undesirable change at the injection site (e.g. from premature removal or needle withdrawal).

In some examples, the wearable injection and/or infusion device <NUM> may be configured to measure temperature, such as the temperature of the therapeutic agent inside the container <NUM>. For example, one or more temperature sensors <NUM> may be used to detect a temperature of the container <NUM>. Using this temperature data, a temperature of the therapeutic agent inside the container <NUM> may be predicted based on at least one of a plurality of factors, such as temperature at one or more locations within the injector relative to the temperature of the container, spatial temperature gradient within the injector, rate of change of temperature at the measurement locations of the container (i.e. temporal gradient). Temperature sensor data may be used to predict or estimate ambient environment temperature during transient temperature conditions. By estimating the ambient environment temperature, versus a local temperature within the device, the temperature of the therapeutic agent inside the container can be better predicted over time. Temperature data may be used to indicate whether the wearable injection and/or infusion device <NUM> is ready to perform a dosing procedure. For example, certain therapeutic agents can only be delivered if they are at a predetermined temperature (or temperature range). The wearable injection and/or infusion device <NUM> may prevent delivery of the therapeutic agent if the therapeutic agent is above/below such predetermined temperature (or temperature range). In some examples, the wearable injection and/or infusion device <NUM> may permit delivery of the therapeutic agent that is outside of a predetermined temperature (or temperature range) using an augmented dosing procedure, such as an increased or decreased delivery rate.

Temperature data can also be combined with dose progression data to detect or estimate whether an abnormal delivery rate (or stall in dose progression) is likely caused by a temperature-related change in therapeutic agent viscosity (e.g. stall due to increase in viscosity at cold temperatures). In these scenarios, changes in a temperature data can be used to indicate whether the abnormal delivery condition is expected to resolve (e.g. injection is currently stalled but likely to resume since temperatures are increasing), such as to prevent premature removal for temporary delivery disruptions.

In some examples, the wearable injection and/or infusion device <NUM> may be configured for external communication with a remote device <NUM> via a network, such as shown in <FIG>. The communication may be a one-way communication, wherein the wearable injection and/or infusion device <NUM> is configured to only send information to the remote device <NUM> or receive information from the remote device <NUM>. In other examples, the wearable injection and/or infusion device <NUM> may be configured for two-way communication with the remote device <NUM>, wherein the wearable injection and/or infusion device <NUM> is configured to both send information to the remote device <NUM> and receive information from the remote device <NUM>. In some examples, the wearable injection and/or infusion device <NUM> may have a transceiver-like component (e.g., a transceiver, a separate receiver and transmitter, etc.) that enables the wearable injection and/or infusion device <NUM> to communicate with the remote device <NUM>, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. The transceiver-like component can permit the wearable injection and/or infusion device <NUM> to receive information from the remote device <NUM> and/or provide information to the remote device <NUM>.

In some examples, the network may include one or more wired and/or wireless networks. For example, network may include a cellular network (e.g., a long-term evolution (LTE) network, a third generation (<NUM>) network, a fourth generation (<NUM>) 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 metropolitan area network (MAN), a telephone network (e.g., the public switched telephone network (PSTN)), 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 these or other types of networks.

In some examples, the wearable injection and/or infusion device <NUM> may be configured for wireless external communication, such as using a Bluetooth or Wi-Fi or cellular communication protocol, with an application <NUM> on a remote device <NUM>, such as a tablet or a mobile telephone or a server-based application. The application <NUM> on the remote device <NUM> may be configured to display real-time data regarding the performance of the wearable injection and/or infusion device <NUM>. In some examples, the application <NUM> on the remote device <NUM> may be configured to display any data associated with the wearable injection and/or infusion device <NUM> (<FIG>). In some examples, the wearable injection and/or infusion device <NUM> may have a BLE/MCU radio for wireless external communication with the remote device.

The remote device may be configured to provide contextual instructions to patient during use of the wearable injection and/or infusion device <NUM>. For example, the remote device may provide instructions to patient on how to set up and initiate a dosing procedure using the wearable injection and/or infusion device <NUM>. In some examples, the remote device may indicate to the patient that a dosing procedure is ongoing and provide status indication of various stages of the dosing procedure. In further examples, the remote device may provide instructions to the patient on a procedure to be followed in an extraordinary event, such as in an instance when the dosing procedure may stall. The wearable injection and/or infusion device <NUM> may be configured to send information, using the remote device, to a third party, such as the patient's medical provider or medical insurance company about time, date, and volume of the therapeutic agent delivered to the patient. The wearable injection and/or infusion device <NUM> may contact such third party in case of an extraordinary event, such as by sending a text alert or dialing a telephone number of the third party.

Data from the wearable injection and/or infusion device <NUM> may be transmitted to the remote device in real time and/or the data may be stored in a remote database for post-delivery use. In some examples, the remote device may be used to run a safety protocol prior to when the wearable injection and/or infusion device <NUM> initiates a dosing procedure. For example, the remote device can check for drug recalls, verify that the correct therapeutic agent is used, and/or verify the time and volume of the last dosing procedure. The wearable injection and/or infusion device <NUM> may be blocked from initiating a new dosing procedure depending on whether the safety protocol run on the remote device detects any abnormalities.

In some examples, the wearable injection and/or infusion device <NUM> may have one or more enhanced electronic indicators. For example, the wearable injection and/or infusion device <NUM> may have one or more visual indicators, such as an LED-based indicator with <NUM>-colors (blue, red, white). Alternatively, or in addition, the wearable injection and/or infusion device <NUM> may have one or more audible indicators, such as a piezo-based buzzer with chimes/beeps.

Claim 1:
A delivery device (<NUM>) for delivering a medical fluid to a patient, the delivery device (<NUM>) comprising:
a housing (<NUM>) configured for receiving a container (<NUM>) at least partially filled with the medical fluid;
a drive mechanism associated with the housing (<NUM>) configured for delivering the medical fluid from the container (<NUM>) to the patient in a dosing procedure; and
a module (<NUM>) configured for detecting at least one of a property of the dosing procedure and a property of the medical fluid, the module (<NUM>) comprising:
at least one dose detection sensor (<NUM>) configured for detecting an initiation, progression, and completion of the dosing procedure based on a position of a stopper within the container (<NUM>);
characterized in that:
the module (<NUM>) further comprises at least one activation detection switch (<NUM>) configured for detecting the initiation of the dosing procedure and at least one completion detection switch (<NUM>) configured for detecting the completion of the dosing procedure; and
the at least one activation detection switch (<NUM>) is configured to detect at least one of a position and a velocity of at least one component of the drive mechanism, and wherein the at least one completion detection switch (<NUM>) is configured to detect at least one of a position and a velocity of at least one component of the drive mechanism.