The present disclosure generally relates to systems and methods for controlling the operational state of a medical device and thereby regulating power consumption by the device. More specifically, and without limitation, the present disclosure relates to systems and methods for automatically transitioning a medical device from a lower-power operational state into an active operational state after one or more predetermined conditions are satisfied.
A variety of medical devices exist, including those that are used for administering drugs to a patient, such as insulin. Measuring the quantity and recording the timing of a drug's administration is an integral part of many medical treatments. For many treatments, to achieve the best therapeutic effect, specific quantities of the drug may need to be injected at specific times of the 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 products that are capable of automatically tracking drug administration without requiring a user to manually measure and record the volume and/or time of administration. Medication injection devices, such as glucose injection syringes and pens, have been developed in this area, but there is much room for improvement. For example, such devices would benefit from enhanced functionality and/or reliability.
Another challenge in developing medical devices that automatically track the drug administration is the regulation and maintenance of power, which can be particularly challenging when long storage periods exist between the time of manufacture and the time of use/sale of the device. In particular, for electronics-based medical devices that use a battery or other power source to track drug administration, it can be a challenge to conserve power over a long storage period.
To conserve a battery or other power source, one approach is to enable the device to be manually turned off or disconnected from the power source while it is in storage and to be turned back on or reconnected to the power source shortly before use. However, such an approach requires the addition of a number of structural components (buttons, switches, etc) that increase cost and complexity. Further, due to the complexity of such arrangements, incorrect usage and/or inadvertent power consumption may arise (e.g., due to the user forgetting to turn off the product or leaving it turned on for a long period).
The present disclosure generally relates to systems and methods for controlling the operational state of a medical device, such as a syringe that includes electronics for tracking drug administration. More specifically, and without limitation, the present disclosure relates to systems and methods for automatically transitioning the medical device from a low-power operational state into an active operational state after one or more predetermined conditions are satisfied.
In accordance with one example embodiment, a method is provided for controlling the operational state of a medical device that includes a power source and a sensor for measuring at least one variable. The method includes providing the medical device in a low-power operational state, and periodically measuring the at least one variable using the sensor. The method also further includes determining, based on the periodically measured at least one of the variable, whether one or more transition conditions are satisfied, and transitioning the medical device into an active operational state when it is determined that the one or more transition conditions are satisfied. In accordance with this embodiment, the low-power operational state draws less current from a power source of the medical device than active operational state.
In accordance with another example embodiment, a medical device is provided that includes a power source and a sensor for measuring at least one variable. The medical device also includes at least one processor that is configured to periodically measure the at least one variable using the sensor and determine, based on the periodically measured at least one variable, whether one or more transition conditions are satisfied. In addition, the at least one processor is configured to transition the medical device from a low-power operational state into an active operational state when it is determined that one or more transition conditions are satisfied. According to this embodiment, the lower-power operational state draws less current from the power source than the active operational state.
In accordance with yet another example embodiment, a medical injection device is provided that includes a power source, a sensor for measuring at least one variable, and a transducer that generates signals to track an injected dosage. The device also includes at least one processor that is configured to periodically measure the at least one variable using the sensor and determine, based on the periodically measured at least one variable, whether one or more transition conditions are satisfied. In addition, the at least one processor is configured to transition the medical injection device into an active operational state when it is determined that the one or more transition conditions are satisfied. Furthermore, after the transition of the medical injection device to the active operational state, the at least one processor may determine the amount of an injected dosage based on the output of the transducer.
Before explaining example embodiments of the present disclosure in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The disclosure is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as in the abstract, are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception and features upon which this disclosure is based may readily be utilized as a basis for designing other structures, methods, and systems for carrying out the several purposes of the present disclosure. Furthermore, the claims should be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present disclosure.
The accompanying drawings, which are incorporated in and constitute part of this specification, and together with the description, illustrate and serve to explain the principles of various exemplary embodiments.
Embodiments of the present disclosure provide improved systems and methods for controlling the operational state of a medical device with a power source (such as a battery), whereby the medical device is transitioned into an active operational state after one or more predetermined conditions are satisfied. In accordance with some embodiments, a sensor is used to detect when the medical device is being stored or transported, and causes the medical device to operate in a low-power operational state to conserve the power source. In some embodiments, when it is detected that the medical device is about to be used by the individual, the medical device is caused to transition to an active operational state. When the medical device is in an active operational state, a transducer may be coupled to the power source so that it can track administration of a drug by the medical device.
Reference will now be made in detail to the embodiments implemented according to the disclosure, the examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
For syringe 10 shown in
Transducer 24 may be configured to send and receive ultrasonic signals, and generate an output reflecting, for example, the transmission and receipt of such signals. Microcontroller 26 may be programmed with instructions to control the overall operation of the components of plunger head 22. 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 32, and other electronical components of plunger head 22.
In some embodiments, as shown in
Transducer 24 may include an actuator, piezoelectric element, and/or speaker-like voice coil. Further, as noted above, transducer 24 may generate and send a pressure wave or ultrasonic signal. Transducer 24 may be sized to be smaller than the inner diameter of barrel 12 and, as noted above, encapsulated in an elastomer 21. As shown in
In some embodiments, microcontroller 26 may be attached to a printed circuit board and may include one or more processors, including for example, a central processing unit (CPU). The processor(s) may be implemented using a commercially available processor or may be a custom designed processor (e.g., an application-specific integrated circuit (ASIC)). Microcontroller 26 may include additional components including, 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 programmable instructions and data.
In some embodiments, microcontroller 26 is programmed with a set of instructions to control the operation of transducer 24 and other components of plunger head 22. For example, microcontroller 26 may be programmed with instructions to receive output signals from transducer 24 and calculate the quantity of medication 20 dispensed based on the ultrasonic signals 25 generated by transducer 24. 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 and/or other data reflecting 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 on the change in distance calculate the volume (i.e., amount or quantity) of medication 20 dispensed. In some embodiments, microcontroller 26 may be programmed to take into account signal delays between microcontroller 26 and transducer 24 for the calculation of distance D.
In some embodiments, a second microcontroller may be programmed with a set of instructions to control the operation of transducer 24 and other components of plunger head 22. In some embodiments, the second microcontroller may be a part of transducer 24. For example, the processor may be fabricated in the same substrate as transducer 24 so as to reduce the electrical parasitics between the processor and transducer 24. In these embodiments, the processor send calculated distance D, volume of medication 20 dispensed, and/or volume of medication 20 remaining to microcontroller 26. 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.
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.
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 a non-rechargeable battery that is configured to last the storage and operational life of plunger head 22. For example, in some embodiments, power source 28 may be a conventional small-sized battery (e.g., a watch battery).
At manufacturing stage 410, syringe 10 is manufactured, assembled, and/or prepared for distribution to a storage facility. As shown in
At a sub-stage 414, a fully assembled syringe 10 may be filled with medication 20. In some embodiments, medication 20 may be chilled (e.g., to about 3 degrees Celsius) prior to being drawn into syringe 10 because medication 20, such as insulin, may have a longer shelf life at lower temperatures. In some embodiments, manufacturing stage 410 may further include, for example, a sub-stage (not shown) during which plunger head 22 is attached to plunger 14 and/or a sub-stage (not shown) during which plunger 14 and/or plunger head 22 are inserted into barrel 12.
At distribution stage 420, syringe 10, prefilled with medication 20, may be transported to a storage facility by a vehicle. To preserve the efficacy and/or to prolong the shelf life of medication 20, syringe 10 may be stored in a temperature-controlled compartment of the vehicle while being transported. In some embodiments, the temperature-controlled compartment of the vehicle may be at a temperature lower than the room temperature. For example, the temperature-controlled compartment of the vehicle may be configured to be at a temperature of about 3 degrees Celsius. In some embodiments, it is contemplated that syringe 10 will be subjected to vibrations (e.g., due to road vibrations) and/or other movements (e.g., due to vehicle accelerations/decelerations) during transportation. Alternatively, or additionally, it is contemplated that syringe 10 will be subjected to various noises generated from the vehicle, as well as random noises originating from outside the vehicle. As further described below, these conditions may be detected by plunger head 22 to control the transition of syringe 10 between one or more operational states.
At storage stage 430, syringe 10 may be stored in a storage facility. For example, at storage stage 430, syringe 10 may be stored in a temperature-controlled area of the storage facility to preserve the efficacy and/or to prolong the shelf life of medication 20. The temperature of the temperature-controlled area in the storage facility may be the same as or different from the temperature of the temperature-controlled compartment of the vehicle used for transportation. It will be appreciated that, if syringe 10 is configured to continuously operate in a fully functioning operational state (i.e., an active operational state) while being stored in the storage facility, a significant portion of power stored in power source 28, if not all, would be consumed before syringe 10 is distributed to and/or used by the user.
To address the above challenges, the operational state of the syringe 10 may be controlled to consume a lower amount of power (i.e., a low-power operational state) compared to an active operational state while being stored in the storage facility (i.e., at storage stage 430). In such cases, microcontroller 26 of syringe 10 may detect when syringe 10 is being stored in the storage facility, and based on the detection, maintain syringe 10 in a low-power operational state. Subsequently, syringe 10 may be controlled to transition into an active operational state after syringe 10 leaves the storage facility, e.g., after the user receives syringe 10 and/or shortly before syringe 10 is used. As further described below, one or more predetermined conditions may be detected by plunger head 22 to control the operational state of syringe 10 as it moves into and later out of the storage facility. According to the disclosed embodiments, when syringe 10 is operating in the active operational state, it provides one or more functionalities (e.g., automatic tracking of the injected dosage and communication of such information to a remote device) that are not enabled or operational in the low-power operational state.
In some embodiments, syringe 10 may transition into the low-power operational state at an earlier stage, e.g., at distribution stage 420 or manufacturing stage 410. In such cases, microcontroller 26 of syringe 10 may be configured to detect when syringe 10 is being manufactured or transported in a vehicle, and based on this detection, maintain syringe 10 in the low-power operational state.
According to some embodiments, syringe 10, operating in the low-power operational state, may consume a lower amount of power compared to the active operational state by isolating one or more components from power source 28 or otherwise reducing power consumption. For example, syringe 10, operating in the low-power operational state, may cause a clock frequency of microcontroller 26 to become lower than the maximum clock frequency or turn off a portion of microcontroller 26. In some embodiments, syringe 10, operating in the low-power operational state, may decouple one or more components of syringe 10 from power source 28. For example, syringe 10, operating in the low-power operational state, may open a relay or switch between power source 28 and one or more components (such as transducer 24) so as to prevent current from flowing into the component(s).
In some embodiments, syringe 10 may operate in one of a plurality of low-power operational states. For example, syringe 10 may operate in a first low-power operational state where power is provided to a first subset of components of syringe 10 or in a second low-power operational state where power is provided to a second subset of components of syringe 10. The amount of power consumed in each of the low-power operational states may be the same or different.
Referring again to
Syringe 10 may be reused to inject the remaining medication 20 at least once after the first injection. In such cases, syringe 10 may be controlled to transition into the low-power operational state between injections. Syringe 10 may be stored in the refrigerator between the injections, and syringe 10 may transition into the low-power operational state, for example, when the change in temperature is detected. Alternatively, syringe 10 may be stored outside the refrigerator between injections, and syringe 10 may transition into the low-power operational state, for example, when the measured acceleration is below a threshold amount.
Between t=0 and t=t1, syringe 10 is being manufactured and is at supply chain stage 410 prior to sub-stage 412. Therefore, during this period, the measured temperature may be at the ambient temperature of the factory (T1) since temperature sensor 32 has not been embedded into plunger head 22 and remains is exposed. In some cases, the ambient temperature may be at the room temperature (i.e., 26 degrees Celsius).
Between t=t1 and t=t2, syringe 10 is still being manufactured but has moved to sub-stage 412 of manufacturing stage 410. As discussed above, sub-stage 412 may involve pouring hot, liquid elastomer over the electronics, including temperature sensor 32, to form plunger head 22. Therefore, during this period, the measured temperature may increase to a temperature (T2) that is slightly below the temperature of the liquid elastomer that is poured over the electronics. The measured temperature may subsequently decrease as the elastomer is cooled while hardening. For example, as shown in
Between t=t2 and t=t3, syringe 10 is at sub-stage 414 of manufacturing stage 410. At sub-stage 414, as discussed above, syringe 10 may be filled with or is being filled with medication 20. Therefore, during this period, the measured temperature may decrease to a temperature (T3) that is slightly above the temperature of medication 20.
Between t=t3 to t=t4, syringe 10 is at distribution stage 420. At distribution stage 420, as discussed above, syringe 10 may be loaded onto a temperature-controlled compartment of a vehicle. Also, as discussed above, the temperature-controlled compartment of the vehicle may be configured to be at a temperature below the room temperature so as to preserve the efficacy and prolong the shelf life of medicine 20. Therefore, as shown in
Between t=t4 to t=t5, syringe 10 is at storage stage 430. At storage stage 430, as discussed above, syringe 10 is stored in a temperature-controlled area of the storage facility. Also, as discussed above, the temperature-controlled area of the storage facility may be configured to be at a temperature below the room temperature so as to preserve the efficacy and prolong the shelf life of medicine 20. Therefore, the measured temperature may change to the temperature of the temperature-controlled area (T5). In such cases, T5 may be substantially the same as T4 or T3. In some embodiments, T5 may be between 3 degrees Celsius and 8 degrees Celsius. Additionally, or alternatively, the temperature variation at storage stage 430 may be lower or higher than or the same as the temperature variation at distribution stage 420.
Between t=t5 to t=t6, syringe 10 is at sub-stage 442 of consumer stage 430. At sub-stage 442, as discussed above, syringe 10 may be distributed to the user and stored in the user's refrigerator. Therefore, the measured temperature may change to the temperature inside the user's refrigerator (T6). In such cases, T6 may be between 3 degrees Celsius and 8 degrees Celsius. The temperature variation at sub-stage 442 may be higher than the temperature variation at prior supply chain stages, for example, because the user's refrigerator is opened frequently.
Between t=t6 to t=t7, syringe 10 is at sub-stage 444 of consumer stage 430. At sub-stage 444, as discussed above, syringe 10 may be warmed before being used by the user. Therefore, the measured temperature may be the ambient temperature of the location where the user uses syringe 10. For example, as shown in
In
According to the disclosed embodiments, syringe 10 may operate in one operational state at a given time chosen from the set of operational states 600. However, in some embodiments, syringe 10 may be associated with a plurality of sets of operational states, and syringe 10 may operate in a plurality of operational states, each chosen from a different set of operational states.
In some embodiments, microcontroller 26 may keep track of which operational state(s) syringe 10 is in (i.e., the current operational state). Furthermore, microcontroller 26, when operational, may provide control signals and/or instructions to other electronical components, such as the temperature sensor 26 and transducer 24. Additionally, or alternatively, microcontroller 26 may also execute one or more sets of instructions or programs, such as a diagnostic software, if defined by the current operational state.
According to the disclosed embodiments, syringe 10 may transition from a first operational state to a second operational state by satisfying a transition condition associated with the first operational state. In some embodiments, satisfying a transition condition may be based on one or more criteria involving a time-dependent variable, such as the measured temperature, measured acceleration, internal voltage, and/or internal timer. For example, a transition condition may be satisfied, at least in part, when the measured temperature is within a predetermined range of values for a predetermined amount of time. As another example, a transition condition may be satisfied, at least in part, when the measured temperature changes at a predetermined rate or within a predetermined range. Additionally, or alternatively, satisfying a transition condition may be based on a variance of a variable. For example, a transition condition may be satisfied, at least in part, when the measured temperature is at a predetermined temperature and has a variance that is below a predetermined level of variance. In some embodiments, a transition condition may be based on a plurality of variables. For example, satisfying a transition condition may be based on the at least two of the following measured variables: temperature, sound, acceleration, rotation, gas composition/mixture, and/or light intensity. In another example, satisfying a transition condition may be based on a comparison of at least two of the above variables.
In
According to the disclosed embodiments, operational state 620 defines behavior of syringe 10 after the molding process for forming plunger head 22 is initiated at sub-stage 412 of manufacturing stage 410. Thus, when syringe 10 is in operational state 620, microcontroller 26 may perform one or more functions that are appropriate during and after the formation of plunger head 22. For example, while syringe 10 is in operational state 620, microcontroller 26 may execute a diagnostic program to ensure that one more components have not been damaged by the hot, liquid elastomer poured over the electronics. In some embodiments, operational state 620 may be a low-power operational state.
According to the disclosed embodiments, syringe 10 may transition from operational state 610 to operational state 620 by satisfying a transition condition 615. Transition condition 615 may be satisfied when syringe 10 is determined to have transitioned into sub-stage 412. For example, transition condition 615 may be satisfied, at least in part, when the measured temperature increases from T1 to T2 in a first predetermined amount of time and/or decreases from T2 to T1 in a second predetermined amount of time. As previously discussed, such changes in the measured temperature may be expected when syringe 10 transitions into sub-stage 412 because of the process for forming plunger head 22.
According to the disclosed embodiments, operational state 630 defines behavior of syringe 10 after or while syringe 10 is filled with medication 20 at sub-stage 414 of manufacturing stage 410. Thus, when syringe 10 is in operational state 630, microcontroller 26 may perform one or more functions that are appropriate while syringe 10 is being filled with medication 20 and/or after syringe 10 is filled with medication 20. For example, while syringe 10 is in operational state 620, microcontroller 26 may execute a program that calibrates transducer 30.
According to the disclosed embodiments, syringe 10 may transition from operational state 620 to operational state 630 by satisfying a transition condition 625. Transition condition 625 may be satisfied when syringe 10 is determined to have transitioned into sub-stage 414. For example, transition condition 625 may be satisfied, at least in part, when the measured temperature changes to T3 in a predetermined amount of time. As discussed above, such changes in the measured temperature may be expected when syringe 10 transitions into sub-stage 414 because, for example, medication 20 may be chilled before being drawn into syringe 10. According to the disclosed embodiments, operational state 640 defines behavior of syringe 10 after or while syringe 10 is transported to a storage facility in a vehicle at distribution stage 420. Thus, when syringe 10 is in operational state 640, microcontroller 26 may perform one or more functions that are appropriate during or after syringe 10 is loaded onto a temperature-controlled compartment of a vehicle. For example, while syringe 10 is in operational state 640, microcontroller 26 may use transceiver 30 to communicate with an inventory system accessible through a transceiver installed in the vehicle. In some embodiments, operational state 640 may be a low-power operational state. In embodiments where syringe 10 is associated with a plurality of low-power operational states, operational state 640 may be the low-power operational state consuming the lowest amount of power.
According to the disclosed embodiments, syringe 10 may transition from operational state 630 to operational state 640 by satisfying a transition condition 635. Transition condition 635 may be satisfied when syringe 10 is determined to have transitioned into distribution stage 420. For example, transition condition 635 may be satisfied, at least in part, when the measured temperature changes from T3 to T4 in a predetermined amount of time. Additionally, or alternatively, transition condition 635 may be defined such that transition condition 635 is satisfied, at least in part, when a road noise or vehicle vibration is detected using, for example, a microphone or inertial sensors. As discussed above, such changes in the measured temperature, noises, and/or vibrations may be expected when syringe 10 is loaded onto a vehicle and transitions into distribution stage 420.
According to the disclosed embodiments, operational state 650 defines behavior of syringe 10 while being stored in a storage facility at storage stage 430. Thus, when syringe 10 is in operational state 650, microcontroller 26 may perform one or more functions that are appropriate while syringe 10 is being stored in a temperature-controlled area of the storage facility. For example, while syringe 10 is in operational state 650, microcontroller 26 may use transceiver 30 to communicate with an inventory system accessible through a transceiver installed in the storage facility. In some embodiments, operational state 650 may be a low-power operational state. In embodiments where syringe 10 is associated with a plurality of low-power operational states, operational state 650 may be the low-power operational state consuming the lowest amount of power.
According to the disclosed embodiments, syringe 10 may transition from operational state 640 to operational state 650 by satisfying a transition condition 645. Transition condition 645 may be satisfied when syringe 10 is determined to have transitioned into storage stage 430. For example, transition condition 645 may be defined such that transition condition 645 is satisfied, at least in part, when measured temperature changes from T4 to T5 in a predetermined amount of time. As discussed above, such changes in the measured temperature may be expected when syringe 10 is unloaded from the vehicle and stored in the storage facility.
According to the disclosed embodiments, operational state 660 defines behavior of syringe 10 after syringe 10 has been sold/provided to a user at consumer and is being stored in a refrigerator of the user at sub-stage 442 of consumer stage 440. Thus, when syringe 10 is in operational state 660, microcontroller 26 may perform one or more functions that are appropriate while syringe 10 is in the refrigerator of the user. For example, while syringe 10 is in operational state 660, microcontroller 26 may use transceiver 30 to communicate with an inventory system accessible through a wireless router installed in the user's home.
According to the disclosed embodiments, syringe 10 may transition from operational state 650 to operational state 660 by satisfying a transition condition 655. Transition condition 655 may be satisfied when syringe 10 is determined to have transitioned into sub-stage 442 of consumer stage 440. For example, transition condition 655 may be defined such that transition condition 655 is satisfied, at least in part, when the measured temperature changes from T5 to T6 in a predetermined amount of time. In another example, transition condition 655 may be defined such that transition condition 655 is satisfied, at least in part, when the variability of the measured temperature changes. As discussed above, such changes in the measured temperature and/or variability may be expected when syringe 10 is moved from the storage facility into the refrigerator of the user (e.g., due to the difference in the temperature of the storage facility and the refrigerator).
According to the disclosed embodiments, operational state 670 defines behavior of syringe 10 after or while syringe 10 is warmed up before being injected into the user at sub-stage 444 of consumer stage 440. Thus, syringe 10 (or microcontroller 26) in operational state 670 may perform one or more functions that are appropriate after or while syringe 10 is removed from the refrigerator of the user and is warmed up before being injected into the user. In some embodiments, operational state 670 may be an active operational state, as discussed above with respect to
In some embodiments, microcontroller 26 may use transceiver 30 to pair and being communicating with the user's remote device. After the pairing of syringe 10 with the remote device, microcontroller 26 may periodically determine the volume of remaining medication 20 in syringe 10 using transducer 30 and transmit the information to the remote device. Furthermore, the remote device may be configured to log the received information and track the injected dosage. The remote device may be further configured to communicate the tracked dosage information to a third party. For example, the remote device may be configured to send the dosage information to a health care professional or to a program executing on a cloud platform to be analyzed.
According to the disclosed embodiments, syringe 10 may transition from operational state 660 to operational state 670 by satisfying a transition condition 665. Transition condition 655 may be satisfied when syringe 10 is determined to have transitioned into sub-stage 444 of consumer stage 440. For example, transition condition 665 may be defined such that transition condition 655 is satisfied, at least in part, when the measured temperature changes from T6 to T7 in a predetermined amount of time. As discussed with reference to
It will be appreciated from this disclosure that process 700 may also be implemented to control the operational state of a non-medical device. For example, process 700 may be performed to control the operational state of a mobile phone, a tablet device, a laptop, or a wearable device. In another example, process 700 may be performed by an Internet-of-Things (IOT) device. Also in some embodiments, process 700 may be implemented for a device supplementing a medical device. For example, process 700 may be performed to control the operational state of a device attached to a packaging of a medical device.
Referring again to
At step 720, the processor may measure, periodically, at least one variable using a sensor of the medical device. In some embodiments, the processor may be configured to periodically measure the at least one variable approximately once one minute, once per hour, or once per day. In cases where multiple variables are measured, the processor may be configured to measure the variables at the same or different rates (e.g., a first variable of the at least one variable at a first rate and a second variable of the at least one variable at a second rate).
In some embodiments, the processor may measure a variable depending on the operational state of the medical device. For example, the processor may control a sensor to measure the variable at a first rate while the medical device is in the first operational state and at a second rate while the medical device is in a second operational state. In still other embodiments, the processor may be configured to measure a first variable using a first sensor while the medical device is in a first operational state and measure a second variable using a second sensor while the medical device is in the second operational state.
In some embodiments, the sensor may be a temperature sensor, a voltage-sensing circuit, a current-sensing circuit, accelerometer, gyroscope, microphone, light sensor, or gas sensor and configured to measure ambient temperature, voltage, current, linear acceleration, angular acceleration, sound level, light intensity, or gas concentration, respectively. In some embodiments, the variable may be a composite variable calculated based on a plurality of variables.
At step 730, the processor may determine, based on the measurement of at least one variable, whether one or more transition conditions are satisfied. In some embodiments, the determination of whether the one or more transition conditions are satisfied may be based on whether the measured variable is in a predetermined range of values for a predetermined amount of time. For example, the one or more transition conditions may be satisfied when a measured temperature is between 3 and 8 degrees Celsius, between 17 and 28 degrees Celsius, above 2 degrees Celsius, or below 40 degrees Celsius.
In some embodiments, the determination of whether the one or more transition conditions are satisfied is based on at least one of: a magnitude of change of the variable, a rate of change of the variable, and a variability of the variables. For example, the one or more transition conditions may be satisfied when the measured temperature changes by 5-10 degrees Celsius, when the measured temperature changes by a predetermined amount in the last 5 minutes, when the measured temperature is greater than 12 degrees Celsius, or combination thereof. In another example, the one or more transition conditions may be satisfied when variability of the measured temperature increases or decreases.
At step 740, the processor may transition the medical device into a second operational state after the one or more transition conditions are satisfied. In some embodiments, the satisfaction of the transition conditions may be required to follow a predetermined sequence to be deemed satisfied. For example, the medical device may transition from a first operational state to a second operational state when it is determined that a first transition condition is satisfied first and then the second transition condition is satisfied.
In some embodiments, the processor may transition the medical device into an intermediate operational state after a subset of the one or more transition conditions are satisfied in a subset of the predetermined sequence. For example, the processor may transition the medical device from the first operational state to the intermediate operational state after the first transition condition is satisfied and from the intermediate operational state to the second operational state after the second transition condition is satisfied.
In embodiments where the medical device is syringe 10, the processor may track the injected dosage using the output of transducer 30 while the medical device is in the second operational state.
In some embodiments, the processor may transition the medical device back into the first operational state after a second one or more transition conditions are satisfied in a second predetermined sequence. For example, the medical device may be transitioned into the first operational state from the second operational state after a third and a fourth transition conditions are satisfied in order.
In some embodiments, the second operational state may be the active operational state discussed above with respect to
In embodiments where the medical device further includes a transceiver, the processor may be further configured to communicate with a remote device after the transitioning of the medical device into the second operational state.
In the preceding specification, various exemplary embodiments and features have been described with reference to the accompanying drawings. It will, however, be evident that various modifications and changes may be made thereto, and additional embodiments and features may be implemented, without departing from the broader scope of the invention as set forth in the claims that follow. For example, advantageous results still could be if components in the disclosed systems were combined in a different manner and/or replaced or supplemented by other components. Other implementations are also within the scope of the following exemplary claims. The specification and drawings are accordingly to be regarded in an illustrative rather than restrictive sense. Moreover, it is intended that the disclosed embodiments and examples be considered as exemplary only, with a true scope of the present disclosure being indicated by the following claims and their equivalents.
This application claims benefit to U.S. Provisional Application No. 62/431,774, filed on Dec. 8, 2016, the contents of which are incorporated herein by reference.
Number | Date | Country | |
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62431774 | Dec 2016 | US |