Patent Description:
The present disclosure relates generally to the field of tracking administering of medication, and more particularly, apparatus and methods for tracking administering of medication by syringes.

Measuring the quantity and recording the timing of a drug's administration is an integral part of many disease treatments. For many treatments, to achieve the best therapeutic effect, specific quantities of a drug may need to be injected specific times of day. For example, individuals suffering from diabetes may be required to inject themselves regularly throughout the day in response to measurements of their blood glucose. The frequency and volume of insulin injections must be carefully tracked and controlled to keep the patient's blood glucose level within a healthy range. Currently, there are a limited number of methods or devices for automatically tracking the drug administration without requiring the user to manually measure and record the volume, date, and time. A variety of glucose injection syringes/pens have been developed, but there is much room for significant advancement in the technology in order to reduce the size, lower the cost, and enhanced the functionality thus making them a more viable long term solution. For example, current insulin pens are often disposable, but do not include dosage tracking. A smaller portion of the market is composed of reusable pens which are more expensive, and still don't include good dosage tracking capabilities. <CIT> discloses a dosage control system which includes a syringe and a dosage control module.

The present disclosure is directed to systems and methods of drug administration using a syringe with a smart plunger head.

In one aspect, the present disclosure is directed to a plunger head for a syringe. The plunger head may include a transducer that sends and receives ultrasonic signals. The plunger may also include an antenna and a microcontroller that interfaces with the transducer and the antenna. The plunger may also include a power source that powers the microcontroller and the transducer. The transducer, the antenna, the microcontroller, and the power source may be at least partially encapsulated in an elastomer housing that fits within a barrel of the syringe. The microcontroller may be programmed with instructions to calculate data representative of the quantity of medication dispensed from the barrel and transmit the data to a remote device via the antenna.

In another aspect, the present disclosure is directed to a system for tracking administering of a medication dispensed by a syringe. The system may include a plunger head that fits within a barrel of the syringe. The plunger head may include a transducer that sends and receives ultrasonic signals and a first antenna. The plunger head may also include a first microcontroller that interfaces with the transducer and the antenna. The system may also include a cuff that is attachable to the barrel of the syringe. The cuff may include a second microcontroller, a second antenna that receives information from the plunger head via the first antenna, and a power source. The first microcontroller may be programmed with instructions to measure the time it takes for the ultrasonic signals to travel through the medication in the syringe to an end of the barrel and return to the transducer, the second microcontroller may be programmed with instructions to calculate data representative of the quantity of medication dispensed from the barrel based on a change in the time measured.

In another aspect, the present disclosure is directed to a method of tracking administering of a medication delivered by syringe. The method may include depressing a plunger of the syringe. The method may also include sending and receiving ultrasonic signals from a plunger head installed within a barrel of the syringe. The method may further include measuring the time it takes for the signals to travel through the medication to an end of the barrel and return to the transducer. The method may also include calculating the distance the plunger head travels based on a change in the time and calculating a quantity of the medication dispensed based on the distance the plunger head travels. The method may further include selectively transmitting wirelessly the quantity of the medication dispensed to a remote device.

In another aspect, the present disclosure is directed to a plunger head for a medication injection device. The plunger head may include a transducer that sends and receives ultrasonic signals and an antenna. The plunger head may also include a microcontroller that interfaces with the transducer and the antenna, and a power source that powers the microcontroller and the transducer. The transducer, the antenna, the microcontroller, and the power source may be at least partially encapsulated in an elastomer housing that fits within a barrel of the medication injection device. The microcontroller may be programmed with instructions to calculate data representative of the quantity of medication dispensed from the barrel and transmit the data to a remote device via the antenna.

Reference will now be made in detail to embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Where possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

<FIG> shows a perspective view of a syringe <NUM> designed for ejecting a fluid. Syringe <NUM> may include a barrel <NUM>, a plunger <NUM>, a needle <NUM>, and a hub <NUM> connecting needle <NUM> to barrel <NUM>. Barrel <NUM> may be configured to contain a fluid, for example, a medication <NUM> and syringe <NUM> may be configured to dispense medication <NUM> from needle <NUM> when plunger <NUM> is depressed. A standard syringes usually contains a plunger head at the end of the plunger that seals the top of the barrel and forces the fluid out the needle when the plunger is depressed. The plunger head for a standard syringe is usually just a piece of molded plastic.

For Syringe <NUM> shown in <FIG>, the standard plunger head has been replaced with a smart or intelligent plunger head <NUM> that is configured to measure and register the quantity of medication <NUM> administered and the date and time of administration. Plunger head <NUM> may be installed in a standard syringe by withdrawing plunger <NUM> and removing the standard plunger head and installing smart plunger head <NUM>. In some embodiments, syringe <NUM> may be manufactured and supplied with a smart plunger head <NUM> preinstalled. Smart plunger head <NUM> may be referred herein as either smart plunger head <NUM> or plunger head <NUM>.

Plunger head <NUM> may be sized to correspond with the size of barrel <NUM>. For example, plunger head <NUM> may be formed to fit any size syringe. For example, plunger head <NUM> may be sized to fit a <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> syringe.

<FIG> shows a schematic of plunger head <NUM>, according to an exemplary embodiment. Plunger head <NUM> may include a transducer <NUM>, a microcontroller <NUM>, a power source <NUM>, and an antenna (e.g., for near field communication (NFC) or a transceiver <NUM> (e.g., for BLUETOOTH low energy (BLE) communication). In some embodiments, the components of plunger head <NUM> may be at least partially encapsulated in an elastomer (e.g., rubber, ethylene propylene (EPM), Nitrile (NBR), ethylene propylene diene (EPDM), polybutadiene, and polisoprene). Transducer <NUM> may be configured to send and receive ultrasonic signals. Microcontroller <NUM> may be programmed with instructions to control the overall operation of the plunger head. Transceiver <NUM> may be configured to wirelessly communication with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, and a computer) using one or more wireless communication methods. The one or more wireless communication methods may include, for example, radio data transmission, Bluetooth, (BLE), (NFC), infrared data transmission, electromagnetic induction transmission, and/or other suitable electromagnetic, acoustic, or optical transmission methods. Power source <NUM> may be configured to power transducer <NUM>, microcontroller <NUM>, and transceiver <NUM>.

Transducer <NUM> may be an actuator, piezoelectric element, or speaker-like voice coil configured to generate and send a pressure wave or ultrasonic signal. Transducer <NUM> may be sized to be slightly smaller than the inner diameter of barrel <NUM>. As shown in <FIG>, transducer <NUM> may be configured to generate ultrasonic signals <NUM> (e.g., radiated sound energy waves) and send the ultrasonic signals <NUM> down barrel <NUM> toward hub <NUM> and needle <NUM>. The ultrasonic signals can travel through medication <NUM> along the length of barrel <NUM> and bounce or reflect off an end <NUM> of barrel <NUM> and travel back through medication <NUM> to plunger head <NUM>. The reflected ultrasonic signals can be received and detected by transducer <NUM>. The speed of sound in medication <NUM> may be a known value and thus a distance D can be calculated very accurately based on the time it takes for a ultrasonic signal to travel down and back from transducer <NUM>. As plunger head <NUM> is moved down barrel <NUM> distance D will change and by knowing the diameter of barrel <NUM> then the volume of medication <NUM> dispensed may be calculated based on the change in distance D.

In some embodiments a portion of the transducer <NUM> may make direct physical contact with medication <NUM> (e.g., for the best impedance matching). For embodiments where transducer <NUM> makes direct contact with medication <NUM>, transducer <NUM> may be coated to prevent chemical interactions or to improve mechanical impedance matching between the transducer and medication <NUM>. In some embodiments, transducer <NUM> may be molded directly into the material (e.g., elastomer) of the plunger head <NUM>. It is contemplated that there are a variety of configures for maximizing the transfer of ultrasonic signals <NUM> from transducer <NUM> to medication <NUM> and from medication <NUM> to transducer <NUM>.

In some embodiments, transducer <NUM> may be configured to vibrate in order to numb the needle injection site so that the pain is reduced.

As shown in <FIG>, in some embodiments, a porous membrane <NUM> may be placed within barrel <NUM> at end <NUM>. Porous membrane <NUM> may be designed to allow medication <NUM> to pass through while providing a surface with good reflective properties for the ultrasonic signals <NUM> to reflect from. Utilizing porous membrane <NUM> may improve the accuracy of the reflective wave detection and thereby the distance and volume calculations. It is contemplated that other materials may be used besides a porous membrane. It is also contemplated that the geometry of barrel <NUM> at end <NUM> may dictate whether a porous membrane is needed. For example, in some embodiments the geometry of end <NUM> may be designed to produce the desired reflective properties avoiding the need to porous membrane <NUM>.

Microcontroller <NUM> may include one or more processors, including for example, a central processing unit (CPU). The processors may include any suitable type of commercially available processor or may be a custom design. Microcontroller <NUM> may include additional components, for example, non-volatile memory (e.g., a flash memory), volatile memory (e.g., a random access memory (RAM)), and other like components, configured to store information).

Microcontroller <NUM> may be programmed with instructions to control the operation of transducer <NUM>. Microcontroller <NUM> may be programmed with instructions to calculate data representative of the quantity of medication <NUM> dispensed. For example, in some embodiments, microcontroller <NUM> may be programmed to detect and record the reflection times of the ultrasonic signals <NUM>. Based on the reflection times, microcontroller <NUM> may track and produce a time profile of the distance between transducer <NUM> (i.e., plunger head <NUM>) and end <NUM>. Based on the time profile of the distance, microcontroller <NUM> may be able to identify a first distance D<NUM> or starting position (e.g., before medication <NUM> is dispensed), which may correspond with barrel <NUM> being filed and a second distance D<NUM> or ending position (e.g., after medication <NUM> is dispensed), which may correspond with barrel <NUM> being empty. Microcontroller <NUM> may then calculate the change in distance between D<NUM> and D<NUM> and based off of the change in distance may calculate the volume (i.e., amount or quantity) of medication <NUM> dispensed.

In some embodiments, medication <NUM> may include an active medication ingredient and a buffer solution. The concentration of the active medication ingredient may be known or programmed into microcontroller <NUM> enabling the specific volume of the active medication ingredient to be calculated. In some embodiments, for example, the concentration of the active medication ingredient may be stored in the non-volatile memory of microcontroller <NUM>. In some embodiments, additional information regarding the medication <NUM> may also be stored, for example, ultrasonic velocity vs. temperature data.

In some embodiments, in addition to calculating the volume of medication <NUM> as it is dispensed, plunger head <NUM> may first calculate the volume of medication <NUM> while it was initially loaded into syringe <NUM>. For example, in some embodiments, plunger head <NUM> may send and receive ultrasonic signals while medication <NUM> is being drawn into barrel <NUM>. Calculating both the volume of medication <NUM> as it is loaded and dispensed can act as a verification or double check.

Transducer <NUM> and/or microcontroller <NUM> may be programmed to perform various forms of signal conditioning in order to detect the time of the reflected ultrasonic signals <NUM>. The signal conditioning may include, for example, amplification, filters, and envelope detection. Transducer <NUM> and/or microcontroller <NUM> may use the signal conditioning to determine for example, time to first rising edge or time to maximum reflective value in order to determine the reflection time.

Plunger head <NUM> may transmit the amount of medication <NUM> dispensed along with the time and date it was dispensed to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, and a computer) via one or more of the wireless communication methods. Plunger head <NUM> may have a unique identifier so the remote device may be able to identify and process the information received properly. Plunger head <NUM> may transmit this information to the remote device immediately or shortly after the medication is administered or plunger head <NUM> may store the information until the remote device is within range. The information may be stored, for example, in memory of microcontroller <NUM>. In some embodiments, plunger head <NUM> may wait to initiate transmitting of the information to the remote device until initiated by the remote device. For example, a user may initiate information retrieval on the remote device. In some embodiments, the remote device may transmit the information to a caregiver (e.g., a doctor) or upload the information to the cloud so it may be saved to the patient's medical history and may be accessed by the caregiver. The ability of a caregiver or a patient to access and review the dose history may improve treatment. For example, the ability of a caregiver to review a diabetic insulin injection history and continuous glucose measurement data may enable the caregiver to adjust the prescribe treatment to improve the therapeutic effect, for example, by better stabilizing the patients glucose levels.

In some embodiments, microcontroller <NUM> may be configured to simply detect the reflection time of the ultrasonic signals <NUM> and transmit that to the remote device and the remote device may perform all the calculations. For example, in some embodiments, plunger head <NUM> may be a passive device (e.g., battery free) and the remote device may utilize near field communication (NFC) to control microcontroller <NUM> and transducer <NUM>. For embodiments where plunger head <NUM> is a passive device, plunger head <NUM> may rely on the remote device to keep track of the date and time. By simplifying the functionality of plunger head <NUM> the cost of manufacturing may be reduced.

In some embodiments, plunger head <NUM> may also include a crystal oscillator <NUM> configured to keep accurate time so that the date and time of each injection may be accurately recorded and stored in memory of microcontroller <NUM>. Crystal oscillator may be, for example, a <NUM> crystal oscillator. In some embodiments, microcontroller <NUM> may include an internal RC oscillator, which may be calibrated using crystal oscillator <NUM>. The internal RC oscillator may be, for example, a <NUM> RC oscillator. Internal RC oscillator may provide sufficient time accuracy to measure the position (e.g., distance D) of plunger head <NUM> to within, for example, about <NUM> microns. In some embodiments, transducer <NUM> may be used as an oscillator or as a calibrator for the internal RC oscillator. In some embodiments, the frequency of the RC oscillator may be up-converted on microcontroller <NUM> to a higher frequency. For example, the RC oscillator may be used to drive a higher-frequency phase-locked loop.

Power source <NUM> may be any suitable power source. For example, power source <NUM> may be a battery, a capacitor, or the like. In some embodiments, power source <NUM> may be rechargeable via wireless energy transmission, for example, inductive coupling, resonant inductive coupling, radio frequency (RF) link, or the like. In some embodiments, power source <NUM> may be a non-rechargeable battery that is configured to last the operational life of plunger head <NUM>, for which the operational life may be about <NUM> year, about <NUM> years, about <NUM> years, or more. For example, in some embodiments, power source <NUM> may be a watch battery. In some embodiments, where plunger head <NUM> is a passive device as described herein, power source <NUM> may be eliminated.

Antenna or transceiver <NUM> may be used to communicate with a variety of remote devices (e.g., smart phones, glucose monitors, insulin pumps, computers, etc.). Plunger head <NUM> may transmit the information via any suitable wireless communication method. For example, in some embodiments, plunger head <NUM> may utilize radio data transmission, BLUETOOTH or (BLE), (NFC), infrared data transmission or other suitable method. In some embodiments, information may also be wirelessly transmitted from a remote device to plunger head <NUM> via antenna <NUM>. For example, the date and time may be set by writing to microcontroller <NUM> via the wireless communication.

In some embodiments, plunger head <NUM> may also include a force sensor <NUM>. Force sensor <NUM> may be configured to detect when a force is applied to plunger head <NUM> via plunger <NUM>, which for example may indicate that dispensing of medication is going to be initiated. Force sensor <NUM> may be, for example, a simple spring-loaded switch that is molded into the plunger head <NUM>.

In some embodiments, plunger head <NUM> may be configured to only initiate sending and receiving of the ultrasonic signals <NUM> after force sensor <NUM> has detected a force, which indicates dispensing is going to be initiated. Prior to detecting the force, plunger head <NUM> may be in a low-power sleep state that is designed to conserve power (e.g., battery life. ) while still keeping accurate track of the date and time. In some embodiments, force sensor <NUM> may be configured to detect a force when the medication is being loaded or drawn into syringe <NUM> and cause plunger head <NUM> to "wake up.

In some embodiments, transducer <NUM> may be configured to function as a force sensor thereby eliminating the need for a separate force sensor <NUM>. For example, transducer <NUM> may have a piezoelectric element that may detect the dynamic changes in pressure when a user depresses the plunger <NUM>.

In some embodiments, plunger head <NUM> may also include a temperature sensor <NUM>. Temperature sensor <NUM> may be configured to measure the temperature of medication <NUM>. Microcontroller <NUM> may be configured to use the temperature of medication <NUM> to compensate for variations in the temperature that would affect the speed of sound within the medication, thus improving the accuracy of the distance and volume calculations.

In some embodiments, microcontroller <NUM> may also use temperature sensor <NUM> to monitor the temperature of medication <NUM> to ensure that the temperature of medication <NUM> stays within an acceptable range. The efficacy of some medications is affected by temperature. For example, insulin is sensitive to hot and cold temperature. Plunger head <NUM> thus may use temperature sensor <NUM> to monitor the temperature of medication <NUM> and if the temperature of the medication <NUM> goes beyond the acceptable range then plunger head <NUM> may be configured to send an alert. The type of alert may vary. In some embodiments, plunger head <NUM> may include a display (not shown in <FIG>) and the alert may be a flashing light or a visual indicator. In some embodiments, plunger head <NUM> may include a speaker and the alert may be auditory, for example, a beeping sound. In some embodiments, the alert may be transmitted to a remote device and the remote device may display a visual alert and/or play an auditory alert.

In some embodiments, plunger head <NUM> may also be configured to detect air bubbles in medication <NUM>. Air bubbles if injected can be deadly so detection of air bubbles is advantageous. In order to detect air bubbles, transducer <NUM> of plunger head <NUM> may be configured to detect small ultrasonic echoes created by the reflection of the ultrasonic waves off the air bubbles in addition to the main echo caused by the end of barrel <NUM>. Plunger head <NUM> may be configured to transmit an alert if air bubbles are detected. The alert may be communicated in the same ways as the temperature alert described above.

In some embodiments, plunger head <NUM> may also be configured to differentiate, verify, and/or identify medication <NUM> contained in syringe <NUM>. For example, when barrel <NUM> is loaded with medication <NUM>, plunger <NUM> and plunger head <NUM> may be pulled all the way back to its stopping point and the distance from plunger head <NUM> to end <NUM> of barrel <NUM> may be known enabling microcontroller <NUM> to solve for the speed of sound of the fluid, which depends on temperature and density. The temperature may be measured by temperature sensor <NUM> so the density may be determined and based on the density the amount of solids dissolved in the fluid may also be determined. In addition, the viscosity of the medication <NUM> may be measured based on the amplitude of the reflected ultrasonic signals <NUM> because more viscous fluids dissipate more energy. In some embodiments, plunger head <NUM> may also include electrodes <NUM> connected to microcontroller <NUM> configured to measure the conductivity of medication <NUM>. In some embodiment, the electrodes <NUM> may protrude out from the surface of plunger head <NUM> into barrel <NUM> where the electrodes <NUM> may contact medication <NUM>. With the density, conductivity, and viscosity of medication <NUM> determined, microcontroller <NUM> may have a sufficient number of properties to profile medication <NUM>. In some embodiments, the profiling may be configured to differentiate medication <NUM> in order to determine if it from a prescribed class of medication. In some embodiments, the profiling may be configured to verify that medication <NUM> is the same as the medication that is prescribed for the patient. In some embodiments, the profiling may be configured to identify the medication <NUM>.

According to an exemplary embodiment, plunger head <NUM> as described herein may be combined with a syringe that has been modified to include a piezo linear motor. The piezo linear motor may be incorporated into the wall of the barrel of the syringe and a piezo element may be incorporated into plunger head <NUM>. The piezo linear motor may be configured to drive or "walk" the plunger head <NUM> down the barrel of the syringe by driving the piezo element, thereby forcing the medication from the syringe. This embodiment may enable the piezo linear motor to control medication dispensing while plunger head <NUM> may simultaneously track the amount of medication being dispensed. In some embodiments, plunger head <NUM> may control the piezo linear motor or plunger head <NUM> can communication with a remote device that can control the piezo linear motor such that it dispenses a set amount of medication.

<FIG> shows a smart syringe system <NUM>, according to an exemplary embodiment. System <NUM> may be designed for use with a standard disposable syringe <NUM>. Similar to plunger head <NUM>, smart syringe system <NUM> may be configured to measure and register the quantity of medication <NUM> administered and the date and time of administration. Smart syringe system <NUM> may include a smart or intelligent plunger head <NUM>, similar to plunger head <NUM>, and a cuff <NUM>. In some embodiments, plunger head <NUM> may be designed to be disposable after a single use while cuff <NUM> is reusable. Embodiments of plunger head <NUM> designed to be disposable after a single use may houses only the minimum number of components to carry out its function while any optional or ancillary components may be housed in cuff <NUM> to minimize manufacturing cost of plunger head <NUM>. The manufacturing cost of plunger head <NUM> may also be minimized by using lower cost components (e.g., transducers, antennas, and microcontrollers) and materials (e.g., rubbers, polymers, plastics) that are less robust and durable, and instead may be designed for shorter operational life spans.

Plunger head <NUM> may be designed to be supplied with or installed into a disposable syringe <NUM> and after administering a dose of medication <NUM>, syringe <NUM> along with plunger head <NUM> may be disposed of or recycled. In contrast, cuff <NUM> may be designed to be reused numerous times. For example, a disposable syringe <NUM> may be inserted through cuff <NUM> and after medication <NUM> is administered; cuff <NUM> may be removed from the used syringe <NUM> and be saved for later use.

In some embodiments, both plunger head <NUM> and cuff <NUM> may be reusable. For example, after medication <NUM> is administered by syringe <NUM>, both plunger head <NUM> and cuff <NUM> may be removed and saved for later use.

Plunger head <NUM> and cuff <NUM> can come in different sizes so they may be used with any size syringe. For example, plunger head <NUM> may be sized to fit within the barrel <NUM> of any size syringe <NUM> while cuff <NUM> may be configured to have a passage <NUM> configured to receive any size barrel <NUM> of syringe <NUM>.

Plunger head <NUM> and cuff <NUM> (i.e., the smart syringe system <NUM>) in combination may be configured to have some or all of the same components (e.g., a transducer <NUM>, a microcontroller <NUM>, a power source <NUM>, an antenna <NUM>, crystal oscillator <NUM>, force sensor <NUM>, and a temperature sensor <NUM>) as plunger head <NUM> and perform at least all the same operations as plunger head <NUM>. Some of the components may be housed in plunger head <NUM> while some of the components may be housed in cuff <NUM>. To reduce the manufacturing cost of plunger head <NUM>, as described above, plunger head <NUM> may be designed to house the minimum number of components to carry out its functions. For example, system <NUM> may be configured such that all the components that can be housed in cuff <NUM> are, rather than plunger head <NUM>. In some embodiments, such components may include a form of memory for data storage.

According to an exemplary embodiment, plunger head <NUM> may include the transducer <NUM>, antenna <NUM>, and a microcontroller <NUM> while cuff <NUM> may also include a separate microcontroller, a power source, and a separate antenna. To reduce complexity, plunger head <NUM> may be passive (e.g., battery-free) and configured to be controlled and powered by cuff <NUM> via wireless energy transmission. Cuff <NUM> may also be configured to communicate with a remote device (e.g., a smart phone) thereby enabling the volume of medication and the time and date of administering to be uploaded to another device or the cloud.

In some embodiments, cuff <NUM> may include a display. Cuff <NUM> may be configured to display any alerts (e.g., high temperature or improper medication) to the user. Cuff <NUM> may also display the volume, date, and time after medication has been dispensed. The display may also be configured to allow user input (e.g., touch screen). For example, the user may program in the date, the time, the type of medication or other information.

Plunger head <NUM> and system <NUM> described herein may be utilized for a variety of methods for tracking administering of a medication to a patient delivered by syringe. Various methods of utilizing plunger head <NUM> and system <NUM> will now be explained with reference to <FIG>. In some embodiments, the methods as described herein may be performed by a caregiver (e.g., a doctor or nurse) in a hospital or other inpatient setting. In some embodiments, the methods as described herein may be performed by a caregiver (e.g., a doctor, nurse, or parent) at home or outside a hospital. In some embodiments, the methods as described herein may be performed by the patient. It is contemplated that the methods described herein may be performed in other settings by other individuals.

Plunger head <NUM> may be utilized for a method <NUM> of tracking administering of a medication to a patient delivered by a syringe, according to an exemplary embodiment. In some embodiments, at step <NUM>, method <NUM> may begin by installing plunger head <NUM> into the barrel <NUM> of the syringe <NUM> (e.g., a disposable syringe). In some embodiments, the syringe <NUM> may be supplied with plunger head <NUM> already installed.

Next, at step <NUM>, the barrel <NUM> of the syringe may be filled with the medication <NUM>. The barrel <NUM> may be completely filled or only partially with medication <NUM>. In some embodiments, the syringe <NUM> may be supplied prefilled with medication <NUM>. In some embodiments, plunger head <NUM> may be configured to "wake up" in response to a force applied during the filling, which may be detected by force sensor <NUM>.

Once filled, at step <NUM>, the syringe may then be positioned for administration. For example, the needle may be inserted into the skin of the patient or into a drug delivery port connected to the patient. Once in position, the plunger <NUM> of the syringe <NUM> may be depressed, which forces plunger head <NUM> down the barrel <NUM> and forces the medication <NUM> out the needle <NUM>.

In some embodiments, the initial position of plunger head <NUM> (e.g., the distance between plunger head <NUM> and end <NUM>) may be known by plunger head <NUM>. For example, syringe <NUM> may be full and plunger head <NUM> may know the distance between plunger head <NUM> and end <NUM> when filled. In some embodiments, if syringe <NUM> is used multiple times to deliver a medication <NUM>, the previous position of plunger head <NUM> may be known from the last measurement stored. In some embodiments, the initial position of plunger head <NUM> may be measured using plunger head <NUM> prior to any medication <NUM> being delivered, as described below.

Prior to and while plunger <NUM> is being depressed, plunger head <NUM> may send and receive ultrasonic signals <NUM> via transducer <NUM>, at step <NUM>. Plunger head <NUM> may send and receive ultrasonic signals <NUM> the duration of the time the plunger is being depressed. Plunger head <NUM> may measure a time it takes for each of the ultrasonic signals to travel through the medication to an end of the barrel and return to the transducer, at step <NUM>. In some embodiments, at least a portion of the ultrasonic signals <NUM> may be sent and received before any medication <NUM> is dispensed enabling the initial position of plunger head <NUM> and initial volume of medication <NUM> to be calculated.

As described herein, at step <NUM>, plunger head <NUM> may calculate the distance the plunger head <NUM> travels over the course of dispensing medication <NUM>. At step <NUM>, the quantity of medication <NUM> dispensed may be calculated based on the calculated distance the plunger head <NUM> traveled.

For some embodiments of method <NUM>, the calculation of the quantity of medication dispensed may be performed by a remote device (e.g., a smart phone). In some embodiments, method <NUM> may also include transmitting the quantity of the medication dispensed and the time and date the quantity was dispensed to a remote device. In some embodiments, method <NUM> may also include uploading the quantity of the medication dispensed and the time and date the quantity was dispensed to the cloud. In some embodiments, method <NUM> may also include sending the quantity of the medication dispensed and the time and date the quantity was dispensed to a caregiver.

Although method <NUM> is described with reference to plunger head <NUM>, it may also be performed by system <NUM>, as described herein.

The foregoing description has been presented for purposes of illustration. It is not exhaustive and is not limited to precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. For example, the described embodiments of plunger head <NUM>, <NUM> and cuff <NUM> may be adapted for used with a variety of other medication injection devices, including for example, auto-injectors, auto-syringes, injector pens (e.g., insulin pens), or other drug or medication injection devices.

Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps and/or inserting or deleting steps.

The features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended that the appended claims cover all systems and methods falling within the true scope of the disclosure. As used herein, the indefinite articles "a" and "an" mean "one or more. " Similarly, the use of a plural term does not necessarily denote a plurality unless it is unambiguous in the given context. Words such as "and" or "or" mean "and/or" unless specifically directed otherwise. Further, since numerous modifications and variations will readily occur from studying the present disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the claims.

Computer programs, program modules, and code based on the written description of this specification, such as those used by the microcontrollers, are readily within the purview of a software developer. The computer programs, program modules, or code can be created using a variety of programming techniques. For example, they can be designed in or by means of Java, C, C++, assembly language, or any such programming languages. One or more of such programs, modules, or code can be integrated into a device system or existing communications software. The programs, modules, or code can also be implemented or replicated as firmware or circuit logic.

Claim 1:
A plunger head (<NUM>) for a medication injection device (<NUM>), wherein the plunger head comprises:
a transducer (<NUM>) that sends and receives ultrasonic signals (<NUM>);
an antenna (<NUM>);
a microcontroller (<NUM>) that interfaces with the transducer and the antenna;
characterised in that the plunger head further comprises:
a power source (<NUM>) that powers the microcontroller and the transducer;
wherein the transducer, the antenna, the microcontroller, and the power source are at least partially encapsulated in an elastomer housing that fits within a barrel (<NUM>) of the medication injection device; and
wherein the microcontroller is programmed with instructions to calculate data representative of a quantity of medication (<NUM>) dispensed from the barrel and transmit the data to a remote device via the antenna.