Patent Description:
Embodiments herein generally relate to automated medication delivery and, more particularly, to wireless medication delivery systems using wearable medication delivery devices.

"Artificial pancreas" systems can be medication delivery systems that typically monitor a user's glucose levels, determine an appropriate level of insulin for the user based on the monitored glucose levels, and subsequently dispense the insulin to the user. Sophisticated control algorithms needed for these systems generally require powerful computing resources and significant power resources. As a result, conventional medication delivery systems do not provide for wireless communications between system components, fully autonomous operation, enhanced user experiences involving ubiquitous electronic devices like cellphones, and improved security features. A need therefore exists for an insulin management system that includes such features.

Document <CIT> discloses a wearable automated medication delivery system according to the preamble of claim <NUM>.

In the following description, various embodiments of the present disclosure are described with reference to the following drawings, in which:.

Various embodiments of the present disclosure include systems and methods for delivering a medication to a person using a wearable medical device in accordance with a wireless signal received from an electronic device. In various embodiments, the electronic device is a smart watch, smart necklace, module attached to the medical device, or any other type or sort of electronic device that may be worn or carried on the body of the person and executes an algorithm that computes the times and dosages of delivery of the medication. For example, the electronic device may execute an artificial-pancreas algorithm that computes the times and dosages of delivery of insulin. The electronic device may also be in communication with a sensor, such as a glucose sensor, that collects data on a physical attribute or condition of the person, such as a glucose level. The sensor may be disposed in or on the body of the person and may be part of the medical device or may be a separate device. Alternately, the medical device may be in communication with the sensor in lieu of or in addition to the communication between the sensor and the electronic device. The communication may be direct (if, e.g., the sensor is integrated with or otherwise a part of the medical device) or remote/wireless (if, e.g., the sensor is disposed in a different housing than the medical device). In these embodiments, the sensor and/or medical device contains computing hardware (e.g., a processor, memory, firmware, etc.) that executes some or all of the algorithm that computes the times and dosages of delivery of the medication.

Various embodiments described herein include systems and methods for automatically delivering medication to a user. A sensor coupled to a user can collect information regarding the user. A controller can use the collected information to determine an amount of medication to provide the user. The controller can instruct a drug delivery device to dispense the medication to the user. The drug delivery device can be a wearable insulin pump that is directly coupled to the user. The controller can be part of or implemented in a cellphone. A user can be required to provide a confirmation input to allow a determined amount of insulin to be provided to the user based on detected glucose levels of the user.

<FIG> illustrates a first exemplary wearable automated medication delivery system <NUM>. The wearable automated medication delivery system <NUM> can include a medical device <NUM>. The medical device <NUM> can be attached to the body of a user and can deliver a medication to the user. The medical device <NUM> can be a wearable device. In particular, the medical device <NUM> can be directly coupled to a user (e.g., directly attached to a body part and/or skin of the user). A surface of the medical device <NUM> can include an adhesive to facilitate attachment to the user.

The medical device <NUM> can include a number of components to facilitate automated delivery of a medication to the user. For example, the medical device <NUM> can include a reservoir for storing the medication, a needle or cannula for delivering the medication into the body of the person, and a pump for transferring the medication from the reservoir, through the needle or cannula, into the body of the user. The medical device <NUM> can also include a power source such as a battery for supplying power to the pump and/or other components of the medical device <NUM>.

The medical device <NUM> can store and provide any medication or drug to the user. In various embodiments, the medical device <NUM> can be an automated wearable insulin delivery device. For example, the medical device <NUM> can be the OmniPod® (Insulet Corporation, Billerica, MA) insulin delivery device as described in <CIT>, <CIT>, or <CIT>.

The medical device <NUM> can also contain analog and/or digital circuitry for controlling the delivery of the medication. The circuitry can be implemented as a controller. The circuitry can include discrete, specialized logic and/or components, an application-specific integrated circuit, a microcontroller or processor that executes software instructions, firmware, or any combination thereof. In various embodiments, the control circuitry can be configured to cause the pump to deliver doses of the medication to the person at predetermined intervals. The size and/or timing of the doses may be programmed into the control circuitry using a wired or wireless link by the user or by a third party (such as a health care provider).

Instructions for determining the delivery of the medication to the user (e.g., the size and/or timing of any doses of the medication) can originate locally (e.g., based on determinations made by the medical device <NUM>) or can originate remotely and then provided to the medical device <NUM>. Remote instructions can be provided to the medical device <NUM> over a wired or wireless link. The medical device <NUM> can execute any received instructions for the delivery of the medication to the user. In this way, under either scenario, the delivery of the medication to the user can be automated.

In various embodiments, the medical device <NUM> can communicate via a wireless link <NUM> with an electronic device <NUM>. The electronic device <NUM> can be any electronic device such as, for example, an Apple Watch. The electronic device <NUM> can be a wearable wireless accessory device. The wireless link <NUM> can be any type of wireless link provided by any known wireless standard. As an example, the wireless link can provide communications based on Bluetooth, Wi-Fi, a near-field communication standard, a cellular standard, or any other wireless protocol.

<FIG> illustrates a second exemplary wearable automated medication delivery system <NUM>. The wearable automated medication delivery system <NUM> can also include the medical device <NUM>. As shown in <FIG>, the medical device <NUM> can communicates via a wireless link <NUM> with a sensor <NUM>. The wireless link <NUM> can be the same type of communication link as the link <NUM> in that it can provide wireless communications over any known wireless protocol or standard.

The control circuitry in the medical device <NUM> may include circuitry implementing a wireless transmitter, receiver, and/or transceiver for communication over the link <NUM> or <NUM>. Information may be transmitted between the medical device <NUM> and the electronic device <NUM> over the link <NUM> and/or between the medical device <NUM> and the sensor <NUM> over the link <NUM>. The shared information may include handshake/pairing information, data, commands, status information, or any other such information.

In various embodiments, the electronic device <NUM> transmits a command to the medical device <NUM> that specifies an action for the medical device <NUM> to take regarding delivery of the medication. In another embodiment, the sensor <NUM> sends a signal to the medical device <NUM> via the link <NUM>, and the medical device <NUM> executes an algorithm to determine an action for the medical device <NUM> to take regarding delivery of the medication. The action may be delivery of a bolus of the medication, a change in a time, frequency, or schedule of future deliveries of the medication, a change in a size of future deliveries of the medication, or any other such action. The command may further comprise a bolus size, a bolus time, or any other such additional information. The medical device <NUM> may transmit a confirmation message back to the electronic device <NUM> upon receipt of the command and/or after completion of the action.

In various embodiments, the electronic device <NUM> transmits the command as specified by an algorithm executing thereon, such as an artificial-pancreas algorithm. The algorithm may execute in the context of a software application running on the electronic device. The user may download this application from an application store, such as the Apple iTunes store, or from any other source. The algorithm may be used to compute appropriate times and doses of delivery of the medication. In some embodiments, the algorithm bases these computations at least in part on information known about the person, such as sex, age, weight, or height, and/or on information gathered about a physical attribute or condition of the person (e.g., from the sensor <NUM>). For example, the algorithm may determine an appropriate delivery of the medication based on glucose level monitoring of the user. The software application may further permit the person to access status information regarding the medical device <NUM>, such as its battery level, number of doses remaining, amount of time in use, or other such status information. The software application may instead or in addition allow the person to issue commands to the medical device <NUM>, such as a command to deliver a bolus.

In various embodiments, as shown in <FIG> and <FIG>, the sensor <NUM> is worn on the body of the person or implanted within the person and is used to collect information regarding one or more physical attributes or conditions of the person. The sensor <NUM> can be coupled to the user and worn on a body part of the user. The sensor <NUM> can be a glucose sensor. For example, the sensor <NUM> can be a continuous glucose monitor (CGM). Although the sensor <NUM> is depicted as separate from the medical device <NUM>, in various embodiments, the sensor <NUM> and medical device <NUM> may be incorporated into the same unit. That is, in various embodiments, the sensor <NUM> can be a part of the medical device <NUM> and contained within the same housing of the medical device <NUM> (e.g., the sensor <NUM> can be positioned within or embedded within the medical device).

The sensor <NUM> can include one or more sensing elements, an electronic transmitter, receiver, and/or transceiver for communicating with the electronic device <NUM> over a link <NUM> or with medical device <NUM> over the link <NUM>. The link <NUM> can be the same type of wireless link as the links <NUM> or <NUM>. The sensor <NUM> can also include a power source for supplying power to the sensing elements and/or transceiver. Communications provided by the sensor <NUM> may include data gathered from the sensing elements. This data can be transmitted continually, at periodic intervals, and/or during or after a change in sensed data (e.g., if a glucose level or rate of change in the level exceeds a threshold). The software application executing the algorithm may use this collected information to send a command to the medical device <NUM> to, for example, deliver a bolus to the person, change the amount or timing of future doses, or other commands.

The electronic device <NUM> can be considered to be a wireless accessory device or an intermediate device. In various embodiments, the electronic device <NUM> can relay commands for delivery of a medication from a remote source to the medical device <NUM>. In various embodiments, the electronic device <NUM> can include a controller for determining delivery of the medication (e.g., the electronic device can include a controller for executing an "artificial pancreas" algorithm). The electronic device <NUM> can also relay sensor data from the sensor <NUM> to the medical device <NUM>. In general, the electronic device <NUM> can relay communications between any of the devices depicted in <FIG> and <FIG> (e.g., communications in any direction between any two devices depicted).

The sensor <NUM> can be any type of sensor and is not limited to a CGM. The sensor <NUM> can include one or more sensors housed in the same physical unit.

The electronic device <NUM> and/or the medical device <NUM> may communicate with one more remote devices <NUM>, which may include computers, servers, storage devices, cloud-based services, or other similar devices. The remote device <NUM> may be owned or operated by, for example, health-care companies or services, pharmacies, doctors, nurses, or other such medically-related entities. The remote device <NUM> may include a cloud-based data management system. A user may wish, for example, to back up data collected from the sensor <NUM>, back up a record of medication delivery times and doses provided by the medical device <NUM>, or back up other such information. A wireless link <NUM> may be used to connect the electronic device <NUM> to the remote devices <NUM> and/or a wireless link <NUM> may be used to connect the medical device <NUM> to the remote devices <NUM>. The wireless links <NUM> and <NUM> can be of the same type as the other wireless links described herein.

Alternatively or in addition thereto, the electronic device <NUM> may communicate with a local device <NUM>. The local device <NUM> can be a dedicated control or monitoring device (e.g., a diabetes management device an/or a custom handheld electronic computing device), cellular phone, laptop computer, tablet, desktop computer, or other similar electronic computing device. The local device <NUM> can communicate with the electronic device <NUM> over a wireless link <NUM>. The wireless link <NUM> can be of the same type as the other wireless links described herein.

A software application executing on the local device <NUM> may be used to send commands to the medical device <NUM> (e.g., via the electronic device <NUM>) and/or receive status information about the medical device <NUM> (e.g., via the electronic device <NUM>). In other embodiments, the local device <NUM> instead or in addition communicates directly via a wireless link <NUM> with the medical device <NUM>. The wireless link <NUM> can be of the same type as the other wireless links described herein.

Additionally, the sensor <NUM> may communicate via a wireless link with the local device <NUM>. The local device <NUM> may communicate with the remote devices <NUM> via a wireless link <NUM>. The wireless link <NUM> can be of the same type as the other wireless links described herein.

<FIG> illustrates a third exemplary wearable automated medication delivery system <NUM>. As part of the wearable automated medication delivery system <NUM>, an electronic device <NUM> can hang from a necklace or lanyard hung around a user's neck. Alternatively, the electronic device <NUM> can be a wearable patch. The electronic device <NUM> can operate and provide the functionality of the electronic device <NUM>. That is, the electronic device <NUM> can include some or all of the features described above with reference to the electronic device <NUM> of <FIG>.

Each of the wearable automated medication delivery systems <NUM>, <NUM>, and <NUM> described in relation to <FIG>, <FIG>, and <FIG> can be part of a diabetes management system. Such a diabetes management system can monitor a user's glucose levels (as well as other physical attributes of a person) and can determine appropriate levels of insulin to provide a user over time. The appropriate levels of insulin (e.g., in terms of dosages and delivery times) can be adjusted over time based on the user's glucose levels or other physical conditions. The insulin to provide a user can be determined using an "artificial pancreas" algorithm. The algorithm can be implemented by a controller that executes instructions stored in a memory. The controller can determine the amount of insulin to provide based on received sensor data (e.g., glucose levels of the user). The controller can then instruct the medical device <NUM> of the automated medication delivery systems <NUM>, <NUM>, and <NUM> to automatically deliver the determined amount of insulin to a user.

The controller for determining the delivery of insulin to the user, any sensor used for collecting and providing data to the controller, and any device providing monitoring output information and capable of receiving user input information can be distributed in any manner across any number of devices. In various embodiments, a glucose sensor (e.g., the sensor <NUM>) is provided as a separate device from a wearable insulin pump (e.g., the medical device <NUM>). In various embodiments, a glucose sensor (e.g., the sensor <NUM>) is provided as part of a wearable insulin pump (e.g., the medical device <NUM>). In various embodiments, the controller for determining the delivery of insulin to the user (e.g., the controller for executing the "artificial pancreas" algorithm) can be provided within a wearable insulin pump (e.g., the medical device <NUM>). In various embodiments, the controller for determining the delivery of insulin to the user (e.g., the controller for executing the "artificial pancreas" algorithm) can be provided in a separate electronic device (e.g., the electronic device <NUM>, the electronic device <NUM>, the local device <NUM>, or the remote device <NUM>).

In various embodiments, any device or component forming a part of a diabetes management systems provided by the wearable automated medication delivery systems <NUM>, <NUM>, and <NUM> can communicate wirelessly with any other device or component of the system. Any type of wireless link can be used based on any known wireless standard or protocol. Further, in various embodiments, one or more of the devices or components can communicate with one or more remote severs or computing devices including remote cloud-based server systems to provide further monitoring, backup, storage, and/or processing capabilities. The components shown in the wearable automated medication delivery systems <NUM>, <NUM>, and <NUM> can communicate directly with one another or can communicate indirectly using a relay or intermediate communication device such as, for example, the electronic device <NUM> or <NUM>.

In various embodiments, the controller for determining the delivery of insulin to the user (e.g., for executing an "artificial pancreas" algorithm) can be provided as part of an electronic device (e.g., the electronic device <NUM> or electronic device <NUM>) that is separate from a sensor (e.g., the sensor <NUM>) for monitoring a condition or attribute of the user and separate from a wearable insulin pump (e.g., the medical device <NUM>). Under such a scenario, the sensor <NUM> can send sensor data (e.g., glucose level data or other user data) to the electronic device <NUM> or <NUM>. The electronic device <NUM> or <NUM> can determine an insulin dose based on the received sensor data. The electronic device <NUM> or <NUM> can then communicate the determined dosage to the wearable insulin pump <NUM>. The wearable insulin pump <NUM> can then automatically provide the dosage to the user without patient input. Monitoring data (e.g., glucose level data and/or dosage data) can be provided to a monitoring device (e.g., the local device <NUM> or a remote device <NUM>) for storage or review (e.g., presentation of current or past data related to delivery of the insulin to the user).

In various embodiments, the controller for determining the delivery of insulin to the user (e.g., for executing an "artificial pancreas" algorithm) can be provided as part of the wearable insulin pump (e.g., the medical device <NUM>). Under such a scenario, the sensor <NUM> can send sensor data (e.g., glucose level data or other user data) to the wearable insulin pump <NUM>. The wearable insulin pump <NUM> can determine an insulin dose based on the received sensor data. The wearable insulin pump <NUM> can then automatically provide the dosage to the user without patient input. Monitoring data (e.g., glucose level data and/or dosage data) can be provided to a monitoring device (e.g., the local device <NUM> or a remote device <NUM>) for storage or review (e.g., presentation of current or past data related to delivery of the insulin to the user). Under this scenario, the wearable insulin pump <NUM> (which can operate as a drug delivery device) can include a communications interface built-in to the wearable insulin pump <NUM> to provide wireless communication capabilities. Alternatively, an add-on device can be coupled to the wearable insulin pump <NUM> (e.g., an attachable device) to provide a wireless communication interface and wireless communication capabilities to the wearable insulin pump <NUM>.

In various embodiments, the controller for determining the delivery of insulin to the user (e.g., for executing an "artificial pancreas" algorithm) can be provided as part of the wearable insulin pump (e.g., the medical device <NUM>). Further, the sensor <NUM> can be provided as part of the wearable insulin pump <NUM>. That is, the sensor <NUM> can be embedded within the wearable insulin pump <NUM>. Under such a scenario, the sensor <NUM> can send sensor data (e.g., glucose level data or other user data) to the wearable insulin pump <NUM>. The wearable insulin pump <NUM> can determine an insulin dose based on the received sensor data. The wearable insulin pump <NUM> can then automatically provide the dosage to the user without patient input. Monitoring data (e.g., glucose level data and/or dosage data) can be provided to a monitoring device (e.g., the local device <NUM> or a remote device <NUM>) for storage or review (e.g., presentation of current or past data related to delivery of the insulin to the user).

In various embodiments, the controller for determining the delivery of insulin to the user (e.g., for executing an "artificial pancreas" algorithm) can be provided as part of the local electronic device <NUM>. For example, the local electronic device <NUM> can be a mobile device or a cellphone. The cellphone <NUM> can include an app for determining insulin delivery to the user. Under such a scenario, the sensor <NUM> can send sensor data (e.g., glucose level data or other user data) to the cellphone <NUM> (e.g., directly or indirectly using the electronic device <NUM> or <NUM> as a relay). The cellphone <NUM> can determine an insulin dose based on the received sensor data. The cellphone <NUM> can communicate the insulin dosage information to the wearable insulin pump <NUM>. The cellphone <NUM> can communicate with the wearable insulin pump <NUM> directly or indirectly - for example, indirectly by way of the electronic device <NUM> or <NUM>. After receiving the dosage information, the wearable insulin pump <NUM> can provide the dosage to the user. Monitoring data (e.g., glucose level data and/or dosage data) can be provided to a monitoring device (e.g., the local device <NUM> or a remote device <NUM>) for storage or review (e.g., presentation of current or past data related to delivery of the insulin to the user). As an alternative to a cellphone, the local device <NUM> can be a dedicated handheld electronic computing device that does not include all of the capabilities of a cellphone (e.g., does not provide an Internet connection or cellular communications interface).

When dosage information is generated and/or provided from the cellphone <NUM>, user input can be required before the wearable insulin pump <NUM> is allowed to provide the dosage. For example, a user may be required to confirm a command to provide a dosage before the dosage is provided. The wearable insulin pump <NUM> or the electronic device <NUM> can include an output device for alerting the user that user confirmation is requested. The alert can be alarm provided visually, audibly, or by other means (e.g., such as vibrating). The wearable insulin pump <NUM> or the electronic device <NUM> can further include a user input device for receiving a confirmation input from the user. For example, the user input can be provided by tapping or pressing a button or by receiving an input using an accelerometer provided on the wearable insulin pump <NUM> or the electronic device <NUM>. This confirmation requirement can represent a cybersecurity measure for the safety of the user.

In various embodiments, the user can be required to provide a confirmation input within a predetermined amount of time after the alarm is provided. If the confirmation is not received within the predetermined amount of time, then the delivery of the insulin to the user can be blocked. Alternatively, if the confirmation is received within the predetermined amount of time, then delivery can be provided as planned. The alarm or alert can indicate receipt of an instruction relating to delivery of the insulin to the user. The confirmation can protect the user from erroneously scheduled insulin delivery to the user. In various embodiments, when a dedicated handled electronic device is used rather than a cellphone for the local device, such confirmation requirements may not be implemented as the security risk to the user is reduced.

In various embodiments, the electronic device <NUM> can be provided to include the controller for determining medication dosages and times and/or for providing communications between one or more other components of the systems <NUM>, <NUM>, and <NUM>. In various other embodiments, the electronic device <NUM> is not necessarily present when the controller for determining medication dosages and times can be housed in another component of the systems <NUM>, <NUM>, and <NUM> and/or when the other system components can communicate without using the electronic device <NUM> as an intermediary.

<FIG> and <FIG> illustrate first and second views of the medical device <NUM>. As shown in <FIG> and <FIG>, the medical device <NUM> can include an electronics module <NUM> that is attached or coupled to the medical device <NUM>. Further, the medical device <NUM> can include a pad or other surface <NUM> for adhering to the user. The pad <NUM> can be coupled to a portion of the medical device <NUM>. The pad <NUM> can include an adhesive that can be used to attach the medical device <NUM> to the user.

The attached module <NUM> can include some or all of the features described above with reference to the electronic device <NUM> of <FIG>. In various embodiments, the module <NUM> can include a transceiver to enable the medical device <NUM> to wirelessly communicate with any other device or component depicted in <FIG>, <FIG>, or <FIG>. The module <NUM> and the medical device <NUM> can communicate over any known wireless or wired communication standard or protocol. In some embodiments, for example, near-field communication is used for communication between the medical device <NUM> and the module <NUM>. In other embodiments, a wired connection, such as a universal serial bus connection, is used for communication between the medical device <NUM> and the module <NUM>.

The electronic device <NUM> may be removably attached to the medical device <NUM> so that the electronic device <NUM> may be used with a plurality of medical devices <NUM>. The electronic device <NUM> may be sealed and waterproof. The electronic device <NUM> may have a battery that can be rechargeable using wireless charging.

In various embodiments, the medical device <NUM> described herein includes a user-input device and/or a user-output device. The user-input device can be a button disposed on the device <NUM>, an acceleration sensor for sensing motion of the medical device <NUM>, or any other such input device. The user-output device may be a speaker for playing sound, a vibration generator (e.g., a motorized gear with an offset center of gravity) for creating vibrations, metal terminals for delivering an electric shock to the body of the person, a visual display and/or one or more lights for providing a visual alarm, or any other such output device.

In various embodiments, when a command is received at the medical device <NUM> from the electronic device <NUM>, the electronic device <NUM>, or from the local electronic device <NUM>, an action associated with the command (e.g., delivery of a bolus) is not carried out until input is received from the user. The input may include pressing the button on the medical device <NUM>, shaking the medical device <NUM> (as sensed by the acceleration sensor), tapping the medical device <NUM> one or more times (as sensed by the acceleration sensor), scanning an RFID or NFC tag, keycard, or fob, or any other such input. If an input is not received within a certain amount of time (e.g., <NUM> seconds, one minute, two minutes, or any other amount of time), the medical device <NUM> may not carry out the action. That is, a determined insulin dose may not be delivered. In some embodiments, the output device alerts the person to the arrival of the command at the medical device <NUM> by, for example, sounding an alarm, vibrating, or providing a visual signal. The output device may similarly alert the user after execution of the action and/or if the action is cancelled due to lack of user input.

<FIG> illustrates a flowchart <NUM> of a method for dispensing a medication with a wearable medical device in accordance with the techniques described herein. In a first step <NUM>, a wireless command for an action associated with delivering medication is received from an electronic device. In a second step <NUM>, user input is received from a person wearing the medical device confirming the action. In a third step <NUM>, the action associated with delivering the medication is executed only if the user input confirming the action is received.

The method shown in <FIG> can be implemented in various embodiments that require a user to confirm an action prior to any medication dosage being delivered to the user. As an example, the method of <FIG> can be implemented when a cellphone <NUM> is used to determine the dosage to provide to a user (e.g., the cellphone <NUM> includes a controller that executes an "artificial pancreas" algorithm) and the determined dosage is provided to the wearable insulin pump <NUM> directly from the cellphone <NUM> or by way of the electronic device <NUM> or <NUM>. In various other embodiments described herein, insulin dosages can be provided entirely automatically without patient input.

<FIG> illustrates an exemplary wearable automated medication delivery system <NUM>. The wearable automated medication delivery system <NUM> can include the wearable insulin delivery device <NUM>, the CGM sensor <NUM>, and a handheld electronic computing device <NUM>. The handheld electronic computing device <NUM> can be a mobile device or cellphone or can be a dedicated custom electronic device. The wearable insulin delivery device <NUM> and the CGM sensor <NUM> can each be directly coupled to a user.

The CGM sensor <NUM> can provide sensor data to the wearable insulin delivery device <NUM> and/or the handheld electronic computing device <NUM>. The handheld electronic computing device <NUM> can include a controller or processor and a memory. The memory can store instructions that can be executed by the controller or processor. The instructions can implemented an "artificial pancreas" algorithm. In general, the handheld electronic computing device <NUM> can include a controller for determining a delivery of insulin to the user (e.g., in terms of dosage amounts and times) based on data from the sensor <NUM> and providing a corresponding instruction regarding the determined delivery of the insulin to the wearable insulin delivery device <NUM>.

In various embodiments, as mentioned above, the sensor <NUM> can be provided as part of or embedded within the wearable insulin delivery device <NUM>. Additionally, in various embodiments, as mentioned above, the system <NUM> can include an intermediate wireless device (e.g., the electronic device <NUM> or <NUM>) that can relay information wirelessly between the devices depicted in <FIG>.

In general, the system <NUM> can automatically monitor glucose levels of the user, automatically determine a delivery of insulin to the user based on the monitored glucose levels, and automatically provide the determined amount of insulin to the user. Each of these steps can be performed without any user input or interaction. In various embodiments, a user confirmation can be required before the insulin is provided to the user as discussed above. For example, when handheld electronic computing device <NUM> is implemented as a cellphone, for added security, the user can be required to confirm or acknowledge the determined delivery of insulin to the user. Without receiving such confirmation, the delivery can be blocked or prevented. This security feature can mitigate hacking or other cybersecurity risks.

As discussed above, the wearable insulin delivery device <NUM> can include one or more user output devices that can be used to provide an alarm, alert, or indication to the user that an instruction for insulin delivery has been determined or received. This indication can be audible, visual, and/or vibrational for example. In various embodiments, the indication can include one or more flashing light emitting diodes and/or a vibration provided by the wearable insulin delivery device <NUM>. One or more user input devices provided with the wearable insulin delivery device <NUM> can be used to provide a required confirmation from the user. The input devices can include a button, a touch screen, or an accelerometer (e.g., such that the input can be a tapping or movement of the wearable insulin delivery device <NUM>). Although user input may be needed to ensure the final step of providing the determined level of insulin to the user occurs, such embodiments can be considered as largely automatic with one or more added security features for the user.

Certain embodiments of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those embodiments, but rather the intention is that additions and modifications to what was expressly described herein are also included within the scope of the disclosure. Moreover, it is to be understood that the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express herein, without departing from the scope of the disclosure. In fact, variations, modifications, and other implementations of what was described herein will occur to those of ordinary skill in the art without departing from the the scope of the disclosure. As such, the disclosure is not to be defined only by the preceding illustrative description. Further, many of the techniques and embodiments described are not limited to the delivery of insulin but are applicable to the automated delivery of any medication to a user.

Accordingly, what has been disclosed inter alia is a wearable automated insulin delivery system, comprising a sensor coupled to a user, the sensor detecting glucose levels of the user; a cellphone, the cellphone determining a delivery of insulin to the user based on the detected glucose levels of the user; and a wearable drug delivery device having a reservoir of insulin and a user input device, the wearable drug delivery device directly coupled to the user, the wearable dru delivery device receiving an instruction from the cellphone for the delivery of insulin to the user, wherein the user is required to provide confirmation of delivery using the user input device before the insulin is delivered to the user.

Furthermore, what has also been disclosed is such a system, wherein the wearable drug delivery device includes a user output device and wherein the user output device provides an alarm to the user to prompt the user to provide the confirmation.

Furthermore, what has also been disclosed is such a system, wherein the alarm is a visual alarm.

Claim 1:
A wearable automated medication delivery system, comprising:
a glucose sensor (<NUM>) which can be coupled to a user;
a controller to receive information from the sensor, the controller to determine a delivery of a medication to a user based on the information from the sensor; and
a wearable drug delivery device (<NUM>) which can be directly coupled to the user, the wearable drug delivery device to automatically deliver the medication to the user based on an instruction from the controller;
characterized by an electronics module (<NUM>) which can be removably attached or coupled to the drug delivery device (<NUM>), wherein a wired communication is used for communication between the drug delivery device (<NUM>) and the electronics module (<NUM>), and
wherein the electronics module (<NUM>) provides a wireless communications interface,
wherein the module executes an algorithm that computes the times and dosages of delivery of the medication.