Patent Application
20210202060
The present disclosure relates generally to the field of tracking the administration of medication, and more particularly, apparatus and methods for tracking the administration of medication by medication injection devices.
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.
The present disclosure is directed to apparatuses and methods of drug administration using a medication injection device.
In one aspect, the present disclosure is directed to a plunger head for a medication injection device. The plunger head may include a first component that houses electronic components and a second component that couples to the first component to form the plunger head. When the plunger head is installed within a barrel of the medication injection device the second component may separate the first component from medication contained within the barrel.
In another aspect, the present disclosure is directed to a method of manufacturing a plunger head for a medication injection device. The method may include assembling a first component of the plunger head, which houses electronic components, using lower temperature assembly steps. The method may also include sterilizing the first component using a lower temperature sterilization method. The method may further include molding a second component of the plunger head from an elastomer to define a bucket shape. The method may also include sterilizing the first component using a higher temperature sterilization method. The method may further include attaching the first component to the second component to form the plunger head.
In another aspect, the present disclosure is directed to another plunger head for a medication injection device. The plunger head may include a transducer that sends and receives ultrasonic signals, an antenna, and a microcontroller that interfaces with the transducer and the antenna. The plunger head may also include a power source that powers the microcontroller and the transducer. 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 and to automatically differentiate an air shot of medication versus an injection of medication.
In another aspect, the present disclosure is directed to a method of tracking injections of a medication delivered by a medication injection device. The method may include depressing a plunger of the medication injection device. The method may also include sending and receiving ultrasonic signals from a plunger head installed within a barrel of the medical injection device. 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 plunger head. The method may also include calculating the distance the plunger head travels based on a change in the time. The method may further include calculating a quantity of the medication dispensed based on the distance the plunger head travels. The method may also include automatically differentiating an air shot of medication versus an injection of medication using an algorithm, wherein the algorithm is programmed to recognize an air shot based on one or more conditional states. The method may also include selectively transmitting wirelessly the quantity of the medication dispensed to a remote device.
In another aspect, the present disclosure is directed to another plunger head for a medication injection device. The plunger head may include a transducer that sends and receives ultrasonic signals, an antenna, and a microcontroller that interfaces with the transducer and the antenna. The plunger head may also include a power source that powers the microcontroller and the transducer. The microcontroller may be programmed with instructions to calculate a quantity of medication dispensed from a barrel of the medication injection device based on a plurality of logged data samples and transmit the quantity of medication dispensed to a remote device via the antenna. The microcontroller may also be programmed with instructions to log each data sample in order to generate the plurality of logged data samples at an approximately regular interval. After the quantity of medication is transferred to the remote device, the time and date maintained by the remote device may be used to back-interpolate the time corresponding to each data sample in order to determine the approximate time the quantity of medication was dispensed.
In another aspect, the present disclosure is direction to another method of tracking injections of a medication delivered by a medication injection device. The method may include depressing a plunger of the medication injection device and sending and receiving ultrasonic signals from a plunger head installed within a barrel of the medical injection device. The method may also include measuring the time it takes for the signals to travel through the medication to an end of the barrel and return to the plunger head and determining a position of the plunger head based on the travel time of the signals and logging a data sample representative of the position. The method may further include logging a plurality of the data samples representative of the position of the plunger at an approximately regular interval. The method may also include calculating the distance the plunger head travels based on a change in the position 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. The method may also include back-interpolating the time corresponding to each data sample logged in order to determine the approximate time the quantity of medication was dispensed, using the time and date maintained by the remote device as a reference time.
In another aspect, the present disclosure is directed to another plunger head for a medication injection device. The plunger head may include a transducer that sends and receives ultrasonic signals, an antenna, and a microcontroller that interfaces with the transducer and the antenna. The plunger head may also include a power source that powers the microcontroller and the transducer and a temperature sensor that measures a temperature associated with the plunger head. The plunger head may be stored in a low-power sleep mode prior to use during which the plunger head periodically wakes up to measure the temperature.
In another aspect, the present disclosure is directed to a method of operation for a medication injection device that has a temperature sensor associated with the device that measures an ambient temperature. The method may include entering the medication injection device into a low-power sleep mode. The method may also include periodically measuring the ambient temperature while in the low-power sleep mode and detecting a temperature change and then transitioning the medication injection device into an initialization mode. The method may further include pairing the medication injection device with a remote device while in the initialization mode. The method may also include entering an operational mode after a successful pairing of the medication device with the remote device. The method may further include measuring and logging a plunger head position of the medication injection device once in the operational mode.
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.
10 designed for ejecting a fluid. Syringe 10 may include a barrel 12, a plunger 14, a needle 16, and a hub 18 connecting needle 16 to barrel 12. Barrel 12 may be configured to contain a fluid, for example, a medication 20 and syringe 10 may be configured to dispense medication 20 from needle 16 when plunger 14 is depressed. A standard syringe 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 rubber.
For syringe 10 shown in
Plunger head 22 may be sized to correspond with the size of barrel 12. For example, plunger head 22 may be formed to fit any size syringe. For example, plunger head 22 may be sized to fit a 1 ml, 2 ml, 3 ml, 5 ml, 10 ml, 20 ml, 30 ml, or 50 ml syringe.
Transducer 24 may be configured to send and receive ultrasonic signals. Microcontroller 26 may be programmed with instructions to control the overall operation of the plunger head. Transceiver 30 may be configured to wirelessly communicate with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or 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, near field communication (NFC), infrared data transmission, electromagnetic induction transmission, and/or other suitable electromagnetic, acoustic, or optical transmission methods. Power source 28 may be configured to power transducer 24, microcontroller 26, transceiver 30, temperature sensor 36, and other electronic components of plunger head 22.
In some embodiments, as shown in
In some embodiments, plunger head 22 may formed of a plurality of components. For example, plunger head 22 may be formed of a first component 31 and a second component 33 that may be fixedly or releasably coupled together such that first component 31 and second component 33 may form plunger head 22, as shown in
In some embodiments, as shown in
The thickness of second component 33 may vary. For example, in some embodiments, the thickness of second component may be about 0.5 millimeters, about 0.6 millimeters, about 0.7 millimeters, about 0.8 millimeters, about 0.9 millimeters, about 1 millimeter, about 1.1 millimeter, greater than about 1.1 millimeter, or less than about 0.5 millimeters.
In some embodiments, as shown in
Structural support system 35 may be, for example, a rigid skeleton, cylinder, container, or frame work that surrounds or encloses one or more of the electronic components. Although
In some embodiments, one or more of the electronic components may be exposed from first component 31. For example, in some embodiments, a portion of transducer 24 may be exposed from the bottom of first component 31 so that when first component 31 is inserted within second component 33, it mates flush with second component 33.
In some embodiments, first component 31 may also be designed to facilitate proper positioning and orientation of one or more of the electronic components. For example, the shape of first component 31 and second component 33 may be such that when first component 31 is inserted into second component 33, transducer 24 may be pointed generally down a center of barrel 12 when installed. In some embodiments, second component 33 may also be designed to facilitate proper orientation of antenna/transceiver 30 when receiving first component 31.
Structural support system 35 may be made generally semi rigid or rigid and may be formed of a variety of different materials, for example, plastic, elastomers, composites, metals, or combinations thereof.
In some embodiments, first component 31 may also be arranged to provide additional functionality including, for example, power source 28 (e.g., battery). For example, power source 28 may be positioned such that when no compressive forces are applied to first component 31, then there is no electrical contact between power source 28 and the electronic components, thereby keeping the other electronic components powered down (i.e., conserving power). But when compressive forces are applied to first component 31, power source 28 or one or more of the other electronic components may be moved and brought into electrical contact thereby powering up. In other words, in some embodiments, power source 28 may be positioned within first component 31, such that the compressive force applied by plunger 14 acts as an off/off switch, which initiates (e.g., wakes up or powers up) the electronic components of plunger head 22.
Separating plunger head 22 into first component 31 (that house the electronic components and second component 33 (that contacts the medication) may provide additional advantages. For example, a challenge with monolithic encapsulating or overmolding of electronic components is that the process usually exposes the electronic components to higher temperatures during both the molding step and later sterilization step(s), which may damage the electronic components, in particular, power source 28 (e.g., the battery). By splitting plunger head 22 into separate components (i.e., first component 31 and second component 33), a lower temperature (e.g., about 60 degrees Celsius or less) series of steps for manufacturing and sterilization can be employed for first component 31, which houses the electronic components, while a higher temperature (e.g., greater than about 60 degrees Celsius) series of steps for manufacturing and sterilization can be employed for second component 33, which contacts medication 20. The first component 31 and second component 33 may then be attached (e.g., by adhesive, bonding, or friction), or another attachment means to form a completed sealed and sterile plunger head 22.
Although the multiple component arrangements (e.g., first component 31 and second component 33) is described herein with reference to plunger head 22, it is contemplated that this multiple or separate component arrangement may be utilized in other applications where electronic components are being packaged (e.g., encapsulated or over-molded) for applications of use where they are alongside sensitive materials (e.g., liquids, medications, chemicals, etc.).
A method 200 of manufacturing plunger head 22 formed of first component 31 and second component 33 will now be explained with reference to
Transducer 24 may be an actuator, piezoelectric element, or speaker-like voice coil configured to generate and send a pressure wave or ultrasonic signal. Transducer 24 may be sized to be slightly smaller than the inner diameter of barrel 12. As shown in
As shown in
In some embodiments, microcontroller 26 may be configured to use the temperature of medication 20 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 26 (or simply a controller) may be attached to a printed circuit board and 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 26 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). In some embodiments, microcontroller or controller may include logic that can be dynamically updated in software or the like or may have static logic that is implemented in hardware.
Microcontroller 26 may be programmed with instructions to control the operation of transducer 24. Microcontroller 26 may be programmed with instructions to calculate data representative of the quantity of medication 20 dispensed. For example, in some embodiments, microcontroller 26 may be programmed to detect and record the reflection times of the ultrasonic signals 25. Based on the reflection times, microcontroller 26 may track and produce a time profile of the position of transducer 24 (i.e., plunger head 22). Based on the time profile of the position, microcontroller 26 may be able to identify a first distance D1 or starting position (e.g., before medication 20 is dispensed), which may correspond with barrel 12 being filed and a second distance D2 or ending position (e.g., after medication 20 is dispensed), which may correspond with barrel 12 being empty. Microcontroller 26 may then calculate the change in distance between D1 and D2 and based off of the change in distance may calculate the volume (i.e., amount or quantity) of medication 20 dispensed.
In some embodiments, microcontroller 26 may be programmed to automatically differentiate a portion of the volume dispensed as part of an air shot versus the portion of volume injected into a patient. An air shot may be defined as priming of the medication injection device by dispensing a small quantity (e.g., 2 units) of medication 20 into the air prior to injection. An air shot is a common practice associated with medication injection devices and the primary purposes are to remove bubbles from the medication, fill the needle, and clear any potential debris from the needle (e.g., when a needle is reused). Failure to differentiate the volume disposed as part of an air shot could lead to more medication than was actually injected being recorded and this can lead to inaccurate medication injection records. By recognizing and air shot, microcontroller 26 can subtract the volume of medication dispensed during the air shot from the total volume of medication 20 dispensed to determine the actual volume of medication 20 injected in a patient. In some embodiments, the volume of the air shot and the volume of the actual injection may be logged and recorded so a caregiver may monitor if recommended procedures (e.g., an air shot) are being followed.
Microcontroller 26 may be programmed to recognize an air shot using an algorithm based on one or more conditional states. The algorithm may be programmed to recognize a dispensed volume of medication as an air shot when there is a short gap (e.g., about 5 seconds, about 4 seconds, about 3 seconds, about 2 seconds) between a first volume and a second volume of medication being dispensed. In other words, a first volume of medication dispensed when there is a sequence of at least two or more dispensing events in a row may be recognized as an air shot. In some embodiments, the algorithm may also be programmed to incorporate and recognize an air shot base on the volume of the amount disposed. For example, the algorithm may be programmed to recognize a dispensed volume that is about equal to a recommend air shot volume (e.g., 2 units) as an air shot. In some embodiments, the algorithm may also be programmed to incorporate and recognize an air shot based on an orientation of the medical injection device or plunger head 22. For example, in some embodiments plunger head 22 may include an accelerometer that microcontroller 26 may utilize to determine orientation. In some embodiments, the algorithm may also be programmed to incorporate and recognize an air shot based on a rate of pressure decline of medication 20 within barrel 12 after an initial movement of plunger head 22. For example, transducer 24 may function as a piezoelectric element and measure pressure of medication 20. Further it may be determined that a faster pressure decline may correspond with an air shot because for an air shot medication 20 is just being shot in the air against no back pressure. In comparison, when medication 20 is being injected into a patient there is a back pressure caused by the tissue.
In some embodiments, medication 20 may include an active medication ingredient and a buffer solution. The concentration of the active medication ingredient may be known or programmed into microcontroller 26 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 26. In some embodiments, additional information regarding the medication 20 may also be stored, for example, ultrasonic velocity vs. temperature data.
Transducer 24 and/or microcontroller 26 may be programmed to perform various forms of signal conditioning in order to detect the time of the reflected ultrasonic signals 25. The signal conditioning may include, for example, amplification, filters, and envelope detection. Transducer 24 and/or microcontroller 26 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 22 may transmit data (e.g., the amount of medication 20 dispensed and time and date it was dispensed) to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) via one or more of the wireless communication methods. Plunger head 22 may have a unique identifier so the remote device may be able to identify and process the information received properly. Plunger head 22 may transmit this information to the remote device immediately or shortly after the medication is administered or plunger head 22 may store the information until the remote device is paired and within range. The information may be stored, for example, in memory of microcontroller 26. In some embodiments, plunger head 22 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 prescribed treatment to improve the therapeutic effect, for example, by better stabilizing the patient's glucose levels.
In some embodiments, plunger head 22 may also include a crystal oscillator 32 configured to keep a real time clock (RTC) so that the date and time of each injection may be accurately recorded and stored in memory of microcontroller 26. Crystal oscillator may be, for example, a 32 KHZ crystal oscillator. In some embodiments, microcontroller 26 may include an internal oscillator (e.g., RC oscillator), which may be calibrated using crystal oscillator 32. The internal RC oscillator may be, for example, a 10 MHZ RC oscillator. Internal RC oscillator may provide sufficient time accuracy to measure the position (e.g., distance D) of plunger head 22 to within, for example, about 150 microns. In some embodiments, transducer 24 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 26 to a higher frequency. For example, the RC oscillator may be used to drive a higher-frequency phase-locked loop.
In some embodiments, plunger head 22 may be designed to back-interpolate the time of each injection enabling crystal oscillator 32 to be eliminated. In order to maintain the RTC, crystal oscillator 32 may consume a significant amount of power, thus eliminating the crystal oscillator 32 can save a significant amount of power as well as save space.
Plunger head 22 may back-interpolate the time of each injection by relying on the real time clock of the remote device. The method of back-interpolating may start with plunger head 22 taking and logging a series of data samples (e.g., plunger head 22 positions). Plunger head 22 may be programmed to take and log the data samples at an approximately regular interval. The data samples, may be stored, for example in a memory of microcontroller 26 in the order measured. The data samples may be logged and stored into memory with other data values (e.g., calculated injection volume, temperature, etc.). The collection of logged data samples may be transferred/transmitted (e.g., uploaded) to a remote device, which will receive the data samples in the same order. The remote device may rely on the approximately regular interval of the data sample logging to back-interpolate from the actual time at time of transfer, as determined by the RTC of the remote device. By back-interpolating the approximate time of each data sample logged may be determined. For example, if there were six samples transferred to the remote device and they were known to have been captured at about 60 minute intervals then the remote device may determine the time of each of the six samples were logged working backwards from the time of data transfer. However, this example produces about a 60 minute uncertainty in the calculated time of the data sample points because the time of transfer may not be synchronized with the time of data sample logging. However, plunger head 22 may be programmed to log data samples at a faster frequency to reduce the uncertainty or increase the accuracy. For example, data samples may be logged every 30 minutes, 15 minutes, 10 minutes, 5 minutes, 1 minute, or less than 1 minute.
The approximately regular interval may be determined or maintained by a less accurate, less power consuming, smaller timing device (e.g., an oscillator). It is noted that the reduce accuracy of the timing device may result in the approximately regular interval drifting due to a variety of factors, for example, temperature, voltage, or factory determined offsets. However, in some embodiments, plunger head 22 may store the factory determined offsets and be programmed with instructions to measure and log the temperature and/or voltage. Microcontroller 26 may be programmed with instructions to use the factory determined offsets and the logged temperatures and voltages to generate a model to correct drift (i.e., change in interval) between the approximately regular intervals caused by variability in the temperature and the voltage. This same method may also be used in other embodiments to correct drift even in a more accurate time tracking system (e.g., a quartz referenced system).
Although the above described back-interpolation and drift correction method is described in reference to plunger head 22, it is contemplated that this method could be used in other sensor or sampling systems to provide timestamps of useful accuracy for a sequence of sensor samples that do not contain an accurate time reference. This method provides cost, power, and space savings while providing an accurate time reference for a sensor system.
Antenna or transceiver 30 may be used to communicate with a variety of remote devices (e.g., smart phones, glucose monitors, insulin pumps, computers, etc.). Plunger head 22 may transmit the information via any suitable wireless communication method. For example, in some embodiments, plunger head 22 may utilize radio data transmission, BLUETOOTH or (BLE), near field communication (NFC), infrared data transmission or other suitable method. In some embodiments, information may also be wirelessly transmitted from a remote device to plunger head 22 via antenna 30. For example, the date and time may be set by writing to microcontroller 26 via the wireless communication.
In some embodiments, plunger head 22 may also include a force sensor 34. Force sensor 34 may be configured to detect when a force is applied to plunger head 22 via plunger 14. Force sensor 34 may be, for example, a simple spring-loaded switch that is molded into the plunger head 22. In some embodiments, transducer 24 may be configured to function as a force sensor thereby eliminating the need for a separate force sensor 34. For example, transducer 24 may have a piezoelectric element that may detect the dynamic changes in pressure when a user depresses plunger 14.
Power source 28 may be any suitable power source. For example, power source 28 may be a battery, a capacitor, or the like. In some embodiments, power source 28 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 28 may be a non-rechargeable battery that is configured to last the storage and operational life of plunger head 22, for which the combined storage and operational life may be about 1 year, about 2 years, about 3 years, or more. For example, in some embodiments, power source 28 may be a watch battery. In some embodiments, where plunger head 22 is a passive device as described herein, power source 28 may be eliminated.
It is common for goods, including medical injection devices, to have a long storage life between the time of manufacture and time of use/sale. Products that include embedded electronics, in particular a battery, it can be a challenge to conserve battery power while the products are in storage. Some products have no on/off switch, buttons, or removable/rechargeable batteries, so the traditional approach of disconnecting or turning off the device while in storage may not be feasible. Also, certain products (e.g., medical injection devices) that include perishable goods (e.g., medication) it may be advantageous to have the product monitor the storage environment (e.g., temperature, light, etc.) and log or store this data and this can't be done if the battery is disconnected.
To address this challenge, plunger head 22 may be designed to enter a low-power sleep mode while in storage. Plunger head 22 may be programmed to enter low-power sleep mode as part of the manufacturing and testing process for plunger head 22 or the medication injection device. When in low-power sleep mode the rate of power consumption may be a fraction of the rate of power consumption for normal operation. While in low-power sleep mode, microcontroller 26 may be programmed with instructions to periodically wake up to measure the temperature. Microcontroller 26 may also log the temperature to create a temperature history. Alternatively, in some embodiments microcontroller 26 may be programmed to log the temperature only when there is a change in temperature, thus saving on data storage. The efficacy of some medications is affected by temperature. For example, insulin is sensitive to hot and cold temperatures. Plunger head 22 thus may monitor the temperature medication 20 through storage and up through use to ensure it stays within an acceptable range. If the temperature of the medication 20 goes outside the acceptable range then plunger head 22 may be configured to send an alert. The type of alert may vary. In some embodiments, plunger head 22 may include a display (not shown in
In some embodiments, plunger head 22 may also be designed to utilize the temperature measurement to transition between modes. For example, a medication injection device that includes plunger head 22 and medication 20 may often be stored at a lower temperature (e.g., below a normal room temperature of about 20 to about 22 degrees Celsius). Subsequently, prior to use, often the temperature will be the medication device, including plunger head 22 and in particular medication 20 will be raised to room temperature because injection of cold fluids can be painful. Thus, usually there will be a transition from a lower temperature to a higher temperature shortly before use thereby triggering a change in the mode of plunger head 22.
As described above, in lower power sleep mode plunger head 22 can periodically measure the temperature, thus microcontroller 26 may be programmed to detect the temperature change that is expect prior to use and when detected microcontroller 26 may be programmed to transition plunger head 22 from low-power sleep mode into an initialization mode. Microcontroller 26 may be programmed to pair with a remote device while in the initialization mode. After a successful pairing, microcontroller 26 may be programmed to transition plunger head 22 to an operational mode and start sending and receiving ultrasonic waves and measuring the position of transducer 24. In some embodiments, microcontroller 26 may be programmed to reenter the low-power sleep mode if it is unable pair with a remote device within a certain period of time (e.g., if no remote device is present). Microcontroller 26 may also be programmed to reenter the low-power sleep mode after a period of inactivity (e.g., no measurable change in transducer 24 position after a programmed period of time). Microcontroller 26 may also be programmed to reenter the low-power sleep mode if a subsequent temperature change (e.g., a decrease in temperature from normal room temperature) is detected. Microcontroller 26 may be programmed to transition directly from the low-power sleep mode back to the operational mode if a successful pairing with a remote device has already occurred.
In some embodiments, plunger head 22 may also be configured to detect air bubbles in medication 20. Air bubbles if injected can be deadly so detection of air bubbles is advantageous. In order to detect air bubbles, transducer 24 of plunger head 22 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 12. Plunger head 22 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 22 may also be configured to differentiate, verify, and/or identify medication 20 contained in syringe 10. For example, when barrel 12 is loaded with medication 20, plunger 14 and plunger head 22 may be pulled all the way back to its stopping point and the distance from plunger head 22 to end 27 of barrel 12 may be known enabling microcontroller 26 to solve for the speed of sound of the fluid, which depends on temperature and density. The temperature may be measured by temperature sensor 36 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 20 may be measured based on the amplitude of the reflected ultrasonic signals 25 because more viscous fluids dissipate more energy. In some embodiments, plunger head 22 may also include electrodes 38 connected to microcontroller 26 configured to measure the conductivity of medication 20. In some embodiments, the electrodes 38 may protrude out from the surface of plunger head 22 into barrel 12 where the electrodes 38 may contact medication 20. With the density, conductivity, and viscosity of medication 20 determined, microcontroller 26 may have a sufficient number of properties to profile medication 20. In some embodiments, the profiling may be configured to differentiate medication 20 in order to determine if it from a prescribed class of medication. In some embodiments, the profiling may be configured to verify that medication 20 is the same as the medication that is prescribed for the patient. In some embodiments, the profiling may be configured to identify the medication 20.
According to an exemplary embodiment, plunger head 22 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 22. The piezo linear motor may be configured to drive or “walk” the plunger head 22 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 22 may simultaneously track the amount of medication being dispensed. In some embodiments, plunger head 22 may control the piezo linear motor or plunger head 22 can communication with a remote device that can control the piezo linear motor such that it dispenses a set amount of medication.
Plunger head 42 may be designed to be supplied with or installed into a disposable syringe 10 and after administering a dose of medication 20, syringe 10 along with plunger head 42 may be disposed of or recycled. In contrast, cuff 44 may be designed to be reused numerous times. For example, a disposable syringe 10 may be inserted through cuff 44 and after medication 20 is administered; cuff 44 may be removed from the used syringe 10 and be saved for later use.
In some embodiments, both plunger head 42 and cuff 44 may be reusable. For example, after medication 20 is administered by syringe 10, both plunger head 42 and cuff 44 may be removed and saved for later use.
Plunger head 42 and cuff 44 can come in different sizes so they may be used with any size syringe. For example, plunger head 42 may be sized to fit within the barrel 12 of any size syringe 10 while cuff 44 may be configured to have a passage 46 configured to receive any size barrel 12 of syringe 10.
Plunger head 42 and cuff 44 (i.e., the smart syringe system 40) in combination may be configured to have some or all of the same components (e.g., a transducer 24, a microcontroller 26, a power source 28, an antenna 30, crystal oscillator 32, force sensor 34, and a temperature sensor 36) as plunger head 22 and perform at least all the same operations as plunger head 22. Some of the components may be housed in plunger head 42 while some of the components may be housed in cuff 44. To reduce the manufacturing cost of plunger head 42, as described above, plunger head 42 may be designed to house the minimum number of components to carry out its functions. For example, system 40 may be configured such that all the components that can be housed in cuff 44 are, rather than plunger head 42. In some embodiments, such components may include a form of memory for data storage.
According to an exemplary embodiment, plunger head 42 may include the transducer 24, antenna 30, and a microcontroller 26 while cuff 44 may also include a separate microcontroller, a power source, and a separate antenna. To reduce complexity, plunger head 42 may be passive (e.g., battery-free) and configured to be controlled and powered by cuff 44 via wireless energy transmission. Cuff 44 may also be configured to communicate with a remote device (e.g., a smart phone, a glucose sensor, an insulin pump, or a computer) 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 44 may include a display. Cuff 44 may be configured to display any alerts (e.g., high temperature or improper medication) to the user. Cuff 44 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 22 and system 40 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 22 and system 40 will now be explained with reference to
Plunger head 22 may be utilized for a method 100 of tracking administering of a medication to a patient delivered by a medication injection device (e.g., a syringe), according to an exemplary embodiment. In some embodiments, at step 102, method 100 may begin by installing plunger head 22 into barrel 12 of syringe 10 (e.g., a disposable syringe). In some embodiments, syringe 10 may be supplied with plunger head 22 already installed. For embodiments corresponding to other medication injection devices (e.g., insulin pen), plunger head 22 may be installed as part of the original manufacturing process, which may also include loading of medication 20 (e.g., insulin)
Optionally, at step 104, the barrel 12 of the syringe may be filled with the medication 20. This step may be eliminated for embodiments were the medication 20 comes prefilled. The barrel 12 may be completely filled or only partially with medication 20.
At step 106, 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 14 of the syringe 10 may be depressed, which forces plunger head 22 down the barrel 12 and forces the medication 20 out the needle 16. Optionally, prior to step 106, method 100 may also include performing an air shot which may be automatically differentiated from the actual injection.
In some embodiments, the initial position of plunger head 22 (e.g., the distance between plunger head 22 and end 27) may be known by plunger head 22. For example, syringe 10 may be full and plunger head 22 may know the distance between plunger head 22 and end 27 when filled. In some embodiments, if syringe 10 is used multiple times to deliver a medication 20, the previous position of plunger head 22 may be known from the last measurement stored. In some embodiments, the initial position of plunger head 22 may be measured using plunger head 22 prior to any medication 20 being delivered, as described below.
Prior to and while plunger 14 is being depressed, plunger head 22 may send and receive ultrasonic signals 25 via transducer 24, at step 108. Plunger head 22 may send and receive ultrasonic signals 25 the duration of the time the plunger is being depressed. Plunger head 22 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 110. In some embodiments, at least a portion of the ultrasonic signals 25 may be sent and received before any medication 20 is dispensed enabling the initial position of plunger head 22 and initial volume of medication 20 to be calculated.
As described herein, at step 112, plunger head 22 may calculate the position of plunger head 22 and a distance plunger head 22 travels over the course of dispensing medication 20. At step 114, the quantity of medication 20 dispensed may be calculated based on the calculated distance the plunger head 22 traveled. As described herein, in some embodiments plunger head 22 may automatically differentiate an air shot and if an air shot is performed may subtract the volume of medication 20 dispensed as part of the air shot from the total volume dispensed in order to determine the actual volume of medication 20 injected.
For some embodiments of method 100, the calculation of the quantity of medication dispensed may be performed by a remote device (e.g., a smart phone, a glucose sensor, an insulin pump, or a computer). In some embodiments, method 100 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 100 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 100 may also include sending the quantity of the medication dispensed and the time and date the quantity was dispensed to a caregiver.
For some embodiments, method 100 may also include logging a plurality of data samples (e.g., position of plunger head 22) at an approximately regular interval and then back-interpolating the time corresponding to each data sample logged to determine the approximate time the quantity of medication 20 was disposed using the RTC maintained by the remote device as a reference time.
Although method 100 is described with reference to plunger head 22, it may also be performed by system 40, 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 22, 42 and cuff 44 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 spirit and 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 disclosure.
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.
Other embodiments will be apparent from consideration of the specification and practice of the embodiments disclosed herein. It is intended that the specification and examples be considered as example only, with a true scope and spirit of the disclosed embodiments being indicated by the following claims.
The present application is a continuation of U.S. application Ser. No. 15/499,037, filed on Apr. 27, 2017, which claims the benefit of U.S. Provisional Application No. 62/329,605, filed Apr. 29, 2016, the contents of all of which are hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62329605 | Apr 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15499037 | Apr 2017 | US |
| Child | 17201992 | US |
