Patent Publication Number: US-2021187199-A1

Title: Systems and methods for delivering a substance to a living being

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/671,670 filed May 15, 2018, entitled SYSTEMS AND METHODS FOR DELIVERING A SUBSTANCE TO A LIVING BEING, which is incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present application relates to systems and methods for delivering a substance into a patient. In particular, the present application relates to systems and methods for delivering a dose of a substance into an object and subsequently verifying that the object was a living being. 
     BACKGROUND 
     As drug delivery devices gain new functionalities (e.g., sensors and connectivity), they are being transformed into medication adherence monitoring devices. For the first time, these devices can provide medication consumption data outside of a clinical environment. Further, as health care professionals begin to make treatment and business decisions based on the medication consumption data, validity and accuracy of such data are becoming ever more important. 
     SUMMARY 
     In one embodiment, a device for delivering a dose of a substance to a living being includes (i) a contact sensor positioned such that the contact sensor is in contact with an object when the device is in a proper position for delivering a dose of the substance to the object, (ii) a temperature sensor, (iii) a delivery apparatus configured to deliver a dose of the substance to the object after the delivery apparatus is activated, and (iv) a transmitter configured to communicate with an external device. The device further includes one or more processors configured to determine, using the contact sensor, whether the contact sensor is in contact with the object and activate the delivery apparatus after determining that the contact sensor is in contact with the object. The delivery apparatus, after being activated, delivers a dose of the substance to the object. The processors are further configured to measure, using the temperature sensor, temperature of the object after the delivery apparatus is activated and transmit, using the transmitter, a communication to the external device. The communication includes the measured temperature, and the external device, in response to receiving the communication, (i) determines, based on the measured temperature, whether the object was a living being, and (ii) records that the substance has been delivered successfully to a living being after determining that the object was a living being. 
     In another embodiment, a method for delivering a substance to a living being by a device includes determining whether a contact sensor is in contact with an object, activating a delivery apparatus after determining that the contact sensor is in contact with the object, delivering a dose of the substance to the object after the delivery apparatus is activated, measuring temperature of the object after the delivery apparatus is activated, and transmitting a communication to the external device. The communication includes the measured temperature, and the external device, in response to receiving the communication, (i) determines, based on the measured temperature, whether the object was a living being, and (ii) records that the substance has been delivered successfully to a living being after determining that the object was a living being. 
     In yet another embodiment, a device for delivering a dose of a substance to a living being includes a contact sensor positioned such that the contact sensor is in contact with an object when the device is in a proper position for delivering a dose of the substance to the object, a temperature sensor, and a delivery apparatus configured to deliver a dose of the substance to the object after the delivery apparatus is activated. The device further includes one or more processors configured to determine, using the contact sensor, whether the contact sensor is in contact with the object and activate the delivery apparatus after determining that the contact sensor is in contact with the object. The delivery apparatus, after being activated, delivers a dose of the substance to the object. The processors are further configured to measure, using the temperature sensor, temperature of the object after the delivery apparatus is activated, determine, based on the measured temperature, whether the object was a living being, and record that the substance has been delivered successfully to a living being after determining that the object was a living being. 
     In another embodiment, a method for delivering a dose of a substance to a living being includes determining whether a contact sensor is in contact with an object, activating a delivery apparatus after determining that the contact sensor is in contact with the object, delivering a dose of the substance to the object after the delivery apparatus is activated, measuring temperature of the object after the delivery apparatus is activated, determining, based on the measured temperature, whether the object was a living being, and recording that the substance has been delivered successfully to a living being after determining that the object was a living being. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates an example of a drug delivery device for delivering a dose of a substance to a patient in accordance with the disclosed embodiments. 
         FIG. 2  illustrates various hardware components of the drug delivery device of  FIG. 1 . 
         FIG. 3  illustrates an example of a drug delivery device  100  in accordance with the disclosed embodiments. 
         FIGS. 4-7  illustrate additional examples of arrangements for sensing surfaces in accordance with the disclosed embodiments. 
         FIGS. 8-10  are example graphs illustrating temperature measured by temperature sensor  106  before, during, and after contact sensor  104  is in contact with an object. 
         FIG. 11  illustrates an example of a process  1100  for delivering a substance to a living being by drug delivery device  100  in accordance with the disclosed embodiments 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  illustrates an example of a drug delivery device  100  for delivering a dose of a substance to a patient  120  in accordance with the disclosed embodiments. As shown in  FIG. 1 , drug delivery device  100  may include a delivery apparatus  102 , a contact sensor  104 , and a temperature sensor  106 . Further as shown in  FIG. 1 , delivery apparatus  102  may include an actuator  108 , a container  110 , and a needle  112 . 
     Overview 
     In the example of  FIG. 1 , patient  120  or another person (e.g., a health care professional) is attempting to use drug delivery device  100  to deliver a single dose of a substance (e.g., vaccine, medication) in container  110  into an arm of patient  120  via needled  112 . Here, patient  120  may insert needle  112  of drug delivery device  100  into the arm such that contact sensor  104  comes in contact with the arm when needle  112  is properly inserted (e.g., to a correct depth and/or in a correct orientation). Contact sensor  104 , after determining that it is indeed in contact with an object (i.e., patient  120 ), activates delivery apparatus  102 . In response, delivery apparatus  102 , using actuator  108 , expels a single dose of the substance in container  110  via needle  112 . In one example, container  110  may be a syringe that includes a plunger, and actuator  108  may expel the substance via needle  112 , for example, by pushing on the plunger. 
     Temperature sensor  106  may be arranged to measure temperature at a location proximate to contact sensor  104  and/or to a location where needle  112  would puncture the object. For example, temperature sensor  106  may be disposed adjacent, or substantially proximate (e.g., within −1 cm of each other), to contact sensor  104  and/or a location where needle  112  would puncture the object. 
     Additionally, temperature sensor  106  may be configured to measure the temperature before and while contact sensor  104  comes in contact with an object (i.e., patient  120  in FIG. 1 ). Thus, temperature sensor  106  may be capable of measuring ambient temperature (e.g., when contact sensor  104  is not in contact with the object) as well as temperature of the object while contact sensor  104  is in contact with the object (“contact temperature”). In some embodiments, temperature sensor  106  may be further configured to measure the temperature after contact sensor  104  loses contact (i.e., disengages) with the object (“post-contact temperature”). In some embodiments, the ambient temperature and/or post-contact temperature may be used to calibrate temperature sensor  106  and/or the measured contact temperature. 
     As used herein, the terms “ambient temperature” refer to temperature measured by temperature sensor  104  before contact sensor  104  comes in contact with an object. The terms “contact temperature” refer to temperature measured by temperature sensor  106  while contact sensor  104  is in contact with an object. The terms “post-contact temperature” refer to the temperature measured by temperature sensor  106  after contact sensor  104  disengages with the object. The measured temperature may be considered post-contact temperature (i) for a predetermine amount of time after contact sensor  104  disengages, (ii) until the temperature stabilizes (e.g., variance is below a threshold value), and/or (iii) until the measured temperature reaches, or become close to, a previously-measured ambient temperature or a predetermined temperature. As used herein, the terms “measured temperature” refers to ambient temperature, contact temperature, and post-contact temperature as a collective. 
     After the substance is delivered, the measured temperature may be used to determine whether the object to which the substance was delivered (“target object”) was a living being, as opposed to an inanimate object. The measured temperature may be further used to identify an area of the target object to which the substance was delivered (“delivery area/site”). For example, contact temperature that is maintained between 86° F. and 94° F. (in a 75° F. environment) may indicate that the target object was likely a human being. Similarly, contact temperature that is initially at 92° F. and decreases to 89° F. after −10 seconds may also indicate that the target object was likely a human being and that the delivery area was likely an abdomen or upper thigh area (shortly after the clothing was removed from the area). Contact temperature that increases rapidly (e.g., from 62° F. to 71° F. in 15 seconds) may also indicate that the target object was likely a human being and that the delivery area was likely applied with some ice prior to the delivery of the dose. The inventor(s) of the present application have been determined that the rate at which human skin temperature rises in room temperature after applying ice may be substantially constant. In contrast, contact temperature that is maintained at or around room temperature (e.g., 75° F.) may indicate that the target object was likely an inanimate object (e.g., wet paper towel or an orange). The inventor(s) also determined that the magnitude of temperature decrease or increase may also be affected by the person&#39;s baseline skin temperature and the ambient temperature. 
     In some embodiments, drug delivery device  100  may determine whether the target object was a living being or an inanimate object. Alternatively, or additionally, drug delivery device  100  may transmit data (e.g., measured temperature, contact sensor data) to an external device, and the external device may determine whether the target object was a living being or an inanimate object. 
     Capability to distinguish, after delivering a dose, whether the target object was a living being or an inanimate object is important for various reasons. For example, such a capability may be used to determine whether a patient is adhering to a prescribed regimen in situations where adherence is critical (e.g., a clinical study) and/or in situations where there are reasons for patients to “fake” an injection (e.g., psychiatric patients or “professional” patients being compensated for taking a medication). In another example, such a capability may be used to improve accuracy in determining whether a dose is delivered successfully to a patient. In particular, such a capability may be used to distinguish, for example, an accidental discharge of the drug that may result when an injection device is dropped. In yet another example, such a capability may be used to distinguish a syringe priming process and/or a test/practice injection process (e.g., into a dummy injection pad). 
     Confirming that an injection device is in contact with a patient is important for preventing premature activation and pausing incomplete dosing events. But, while pressure and capacitive sensors may be reliable for detecting contact with an object, they can easily be activated by objects other than patient skin. For example, a patient may be able to activate a drug delivery device using a moist paper towel or an orange. Temperature is a more reliable metric for differentiating between patient tissue and other objects. But, temperature may not be a reliable activation mechanism for a drug delivery device because skin temperature can vary, especially if a patient applies ice to the injection site in order to reduce pain. In contrast, skin temperature can be used to validate drug delivery events that are initiated by other mechanisms. In particular, a constant temperature over the course of a drug delivery event in the range of 30-35 C is highly correlated to patient tissue. A rising skin temperature over the course of a drug delivery event would be correlated to an iced injection site. Thus, a patient sensing system that uses a contact sensor to activate a drug delivery device and a temperature sensor to validate the drug delivery event provides the best of both worlds: reliable device activation and reliable dosing data. 
     In some embodiments, drug delivery device  100  may be an inhalation device and delivery apparatus  102 , after being activated, may release inhalant stored in container  110 . In some embodiments, the inhalation device would be in contact with the user&#39;s lips and/or inner mouth. The temperature recorded before, during and after activation of the inhalation device would indicate whether the device was properly oriented with respect to the user&#39;s mouth. 
     Delivery Apparatus 
     In  FIG. 1 , delivery apparatus  102  may be configured to expel a dose of the substance contained in container  110  via needle  112  (e.g., into the arm of patient  120  if needle  120  is inserted in the arm) after delivery apparatus  102  is activated and/or in response to delivery apparatus  102  being activated. In some embodiments, delivery apparatus  102  may cease expelling the substance after delivery apparatus  102  is deactivated and/or in response to delivery apparatus  102  being deactivated. 
     Delivery apparatus  102  may be activated/deactivated based on a signal from other components of drug delivery device  100 . For example, delivery apparatus  102  may be activated in response to a signal generated by contact sensor  104  indicating that contact sensor  104  is in contact with an object. In another example, delivery apparatus  102  may be activated in response to a signal from a processor indicating that contact sensor  104  is in contact with an object. In yet another example, delivery apparatus  102  may be activated in response to a signal indicating that contact sensor  104  is in contact with an object and an input from a user indicating that the user is ready to receive the dose. Correspondingly, delivery apparatus  102  may be deactivated in response a signal generated by contact sensor  104  indicating that contact sensor  104  is no longer in contact with the object. In another example, delivery apparatus  102  may be deactivated in response to a signal from a processor indicating that contact sensor  104  is no longer in contact with an object. 
     In some embodiments, delivery apparatus  102 , after being activated, may deactivate itself (or be deactivated by another component) (i) after a predetermined amount of time, (ii) after determining that a predetermined amount of the substance (e.g., a dose) is expelled, and/or (iii) after determining that an amount of the substance contained in container  110  has reached a predetermined value. For example, delivery apparatus  102  may deactivate itself after 5 seconds, after 1 mL of the substance is expelled from container  110 , and/or after determining that the volume of the substance in container  110  reached 1 mL. In some embodiments, delivery apparatus  102  may deactivate itself (or be deactivated by another component) after a set of predetermined conditions are met. Such conditions may be met, for example, (i) when contact temperature measured by temperature sensor  106  exhibits an unexpected trend (e.g., sudden drop/increase in temperature), (ii) when the substance is expelled at an unexpected (e.g., too fast for needle  112 ), and/or (iii) when contact pressure sensed by contact sensor  104  fluctuates in an unexpected manner (e.g., too much vibration). Meeting these conditions may indicate, for example, that drug delivery device  100  is malfunctioning and/or being used improperly. 
     In some embodiments, delivery apparatus  102  may be configured to perform additional processes upon activation and/or deactivation. As an example, in some embodiments, needle  112  of delivery apparatus  102  may be retractable. In this example, needle  112  may be in a retracted position initially such that, when contact sensor  104  comes into contact with an object, needle  112  is not in contact with the object. After being activated, delivery apparatus  102  may be configured to extend needle  112  so as to puncture the object and deliver the substance. Correspondingly, after being deactivated, delivery apparatus  102  may be configured to retract needle  112  to disengage with the object. In some embodiments, after being activated, delivery apparatus  102  may be configured to rapidly extend needle  112  so as to puncture the object, deliver a dose of the substance, and rapidly retract needle  112  to disengage with the object after the dose is delivered. 
     In  FIG. 1 , delivery apparatus  102  may deliver a dose of the substance in container  110  using actuator  108 . In some embodiments, container  110  may include a tubular structure containing the substance and a plunger at an end opposite to needle  112 . In these embodiments, actuator  108  may include a linear actuator arranged to push the plunger into the tubular structure such that the substance is expelled through needle  112 . In some embodiments, the linear actuator may include a hollow drive shaft and a lead screw may be disposed inside and connected to the hollow drive shaft. 
     In some embodiments, delivery apparatus  102  may include one or more sensors for detecting an amount of the substance expelled from container  110  and/or an amount of the substance remaining in container  110 . 
     In some embodiments, drug delivery device  100  may be a reusable/recyclable device. In these embodiments, container  110  may include a sufficient amount of the substance for a plurality of doses, and needle  112  may be replaceable and/or cleanable. Alternatively, or additionally, container  110  may be replaceable (e.g., when container  110  no longer contains sufficient amount of the substance for a dose). In some embodiments, container  110  and needle  112  may be mechanically coupled such that both parts can be replaced simultaneously. For example, needle  112  may be a part of a replaceable container  110 . 
     As discussed above, in some embodiments, needle  112  may be retractable. In these embodiments, needle  112  may be manually extended and/or retracted. Alternatively, or additionally, needle  112  may extend and/or retract automatically (e.g., in response to an input from a user or when delivery apparatus  102  is activated/deactivated). In some embodiments, needle  112  may rapidly extend in a manner that can puncture, for example, the arm of patient  120 . In some embodiments, needle  112  may have a length and arranged such that an insertion depth of needle  112  is in a predetermined range (e.g., between 4 mm-12 mm). 
     The processes above are described as being performed by delivery apparatus  102  (e.g., activation/deactivation of delivery apparatus  102 , extending/retraction of needle  112 , actuating actuator  108 ). However, in some embodiments, the processes may be at least partially performed, or enabled, by one or more processors that may be internal and/or external to delivery apparatus  102 . That is, one or more processors may be configured to perform the above-described processes at least partially and/or enable delivery apparatus  102  to perform them. Further, one or more of such processors may be shared among components of drug delivery device  100 . 
     Contact Sensor 
     In  FIG. 1 , contact sensor  104  is used to detects when contact sensor  104  comes into contact with an object, such as an arm of patient  120 . In particular, contact sensor  104  may be arranged relative to other components of drug delivery device  100  such that contact sensor  104  comes in contact with an object after needle  112  is positioned properly for insertion into the object. Further, contact sensor  104  may be configured to activate delivery apparatus  102  after determining that contact sensor  104  is in contact with an object, thereby causing delivery apparatus  102  to expel the substance contained in container  110  into the object. For example, after determining that contact sensor  104  has come in contact with an object, contact sensor  104  may transmit (or cause a processor to transmit) a signal to actuator  108  of delivery apparatus  102 . In some embodiments, contact sensor  104  may further determine whether the contact with the object is proper or not. In these embodiments, contact sensor  104  may be configured to activate delivery apparatus  102  after determining that contact sensor  104  is in in contact with an object and that the contact is also proper. 
     Correspondingly, contact sensor  104  may be configured to deactivate delivery apparatus  102  after determining that contact sensor  104  is no longer in contact with a target object. In embodiments where contact sensor  104  is further configured to determine whether the contact with the object is proper, contact sensor  104  may be configured to deactivate delivery apparatus  102  after determining that contact sensor  104  is no longer in contact with an object or determining that the contact is improper. 
     Furthermore, contact sensor  104  may generate data that can provide context to the temperature data measured by temperature sensor  106  (“temperature context data”). In particular, data generated by contact sensor  104  may be used to determine which portion of temperature data measured by temperature sensor  106  is ambient temperature (i.e., temperature before contact sensor  104  is in contact with an object), which portion is contact temperature (i.e., temperature while contact sensor  104  is in contact with the object), and which portion is post-contact temperature (i.e., temperature when contact sensor  104  is no longer in contact with the object). 
     In some embodiments, contact sensor  104  may be a mechanical sensor that measures pressure applied to a sensing surface. In these embodiments, contact sensor  104  (or a processor(s)) may determine that contact sensor  104  is in contact with an object by determining whether the measured pressure at the sensing surface is above a threshold value and/or maintained above the threshold value for a predetermined amount of time. Correspondingly, contact sensor  104  may determine that contact sensor  104  is not in contact with an object by determining whether the measured pressure at the sensing surface is below a threshold value and/or maintained below the threshold value for a predetermined amount of time. 
     In some embodiments, contact sensor  104  may be an electrical sensor that measures conductivity between points on a sensing surface(s) that is in contact with a target object (i.e., patient tissue). In these embodiments, contact sensor  104  (or a processor(s)) may determine that contact sensor  104  is in contact with the target object by determining whether the measured conductivity is above a threshold value and/or maintained above the threshold value for a predetermined amount of time. Correspondingly, contact sensor  104  may determine that contact sensor  104  is not in contact with an object by determining whether the measured conductivity at the sensing surface is below a threshold value and/or maintained below the threshold value for a predetermined amount of time. 
     The threshold value(s) may be predetermined or dynamically determined, for example, based on data collected from a plurality of drug delivery devices and/or based on data previously collected from drug delivery device  100 . 
     In some embodiments, contact sensor  104  may determine that contact sensor  104  is or is not in contact with the target object when data generated by contact sensor  104  (e.g., data indicative of conductivity or pressure) satisfies one or more predetermined criteria. For example, contact sensor  104  may determine that contact sensor  104  is not in contact with the target object (or that the contact is improper) when the detected pressure/conductivity has a variance above a threshold variance value (e.g., even when the pressure is above the threshold value). In another example, contact sensor  104  may determine that contact sensor  104  is no longer in contact with the target object (or that the contact is improper) when the detected pressure/conductivity suddenly changes by a predetermined amount/percentage (e.g., even when the pressure/conductivity after the change is above the threshold value). 
     In some embodiments, contact sensor  104  may further include an inertial sensor (e.g., accelerometer, gyroscope), a directional sensor (e.g., magnetometer), and/or an image sensor to determine whether drug delivery device  100  is in a proper orientation/position relative to a target object. Such a sensor(s) may be used to determine whether the contact with a target object is proper or not. 
     In some embodiments, data generated by contact sensor  104  (e.g., raw data indicative of conductivity or pressure) may be provided to a processor or other components in drug delivery device  100 . In these embodiments, the data may be used, in conjunction with data from temperature sensor  106 , to determine whether a target object was a living being or an inanimate object. 
     In some embodiments, contact sensor  104  may include a plurality of sensors. For example, contact sensor  104  may include both a mechanical sensor and an electrical sensor described above. 
     The processes above are described as being performed by contact sensor  104  (e.g., determining whether there is contact, determining whether the contact is proper, activating/deactivating delivery apparatus  102 , generating temperature context data). However, in some embodiments, the processes may be at least partially performed, or enabled, by one or more processors that may be internal and/or external to contact sensor  104 . That is, one or more processors may be configured to perform the above-described processes at least partially and/or enable contact sensor  104  to perform them. Further, one or more of such processors may be shared among components of drug delivery device  100 . 
     Temperature Sensor 
     As discussed above, temperature sensor  106  may be capable of measuring ambient temperature, contact temperature, post-contact temperature. The terms “ambient temperature” refers to the temperature measured by temperature sensor  104  before contact sensor  104  comes in contact with an object. The terms “contact temperature” refers to the temperature measured by temperature sensor  106  while contact sensor  104  is in contact with an object. The terms “post-contact temperature” refers to the temperature measured by temperature sensor  106  after contact sensor  104  disengages with the object. 
     Temperature sensor  106  may be configured to detect temperature at a location near contact sensor  104 . Accordingly, temperature sensor  106  may be capable of measuring temperature of an area of an object that comes in contact with contact sensor  104  (“contact area”). In some embodiments, temperature sensor  106  may be disposed adjacent, or substantially proximate, to contact sensor  104 . 
     In some embodiments, temperature sensor  106  may be configured to make at least one measurement of ambient temperature. In some embodiments, temperature sensor  106  may be configured to make a plurality of measurements of ambient temperature. In some embodiments, temperature sensor  106  may be configured to make measurements of ambient temperature periodically and/or based on a predetermined timing scheme. For example, temperature sensor  106  may be configured to make a measurement of ambient temperature every 5 seconds. In some embodiments, measurement rate for ambient temperature may be dynamically determined based on a number of factors including, for example, battery level, rate of change in the recently measured ambient temperature, and/or variance of the recently measured ambient temperature. For example, temperature sensor  106  may increase the measurement rate for ambient temperature when the variance of the ambient temperature measured in the last few minutes are above a threshold variance. In another example, temperature sensor  106  may increase the measurement rate for ambient temperature when the last several measured ambient temperatures show a sharp increase/decrease. In yet another example, temperature sensor  106  may decrease the measurement rate for ambient temperature when drug delivery device  100  has less than, for example, −10% battery level. 
     In some embodiments, temperature sensor  106  may make at least one measurement of contact temperature. In some embodiments, temperature sensor  106  may be configured to make a plurality of measurements of contact temperature. In some embodiments, temperature sensor  106  may be configured to make measurements of contact temperature periodically and/or based on a predetermined timing scheme. For example, temperature sensor  106  may be configured to make a measurement of contact temperature every 10 milliseconds. In some embodiments, measurement rate for contact temperature may be dynamically determined based on a number of factors including, for example, rate of change in the recently measured contact temperature, and/or variance of the measured contact temperature. For example, temperature sensor  106  may increase the measurement rate for contact temperature when the variance of the contact temperature measured in the last few measurements are above a threshold variance. In another example, temperature sensor  106  may increase the measurement rate for contact temperature when the last several measurements show a sharp increase/decrease. In some embodiments, a measurement rate of contact temperature may be higher than a measurement rate of ambient temperature. 
     In some embodiments, temperature sensor  106  may make at least one measurement of post-contact temperature. In some embodiments, temperature sensor  106  may be configured to make a plurality of measurements of post-contact temperature. As discussed above, the measured temperature may be considered post-contact temperature, as opposed to ambient temperature, for a predetermine amount of time after contact sensor  104  disengages a target object, until the temperature stabilizes (e.g., variance is below a threshold value), and/or until the measured temperature reaches, or become close to, a previously-measured ambient temperature or a predetermined temperature. In some embodiments, the post-contact temperature may include at least one measurement after the temperature stabilizes. 
     In some embodiments, temperature sensor  106  may be configured to make measurements of post-contact temperature periodically and/or based on a predetermined timing scheme. For example, temperature sensor  106  may be configured to make a measurement of post-contact temperature every 10 milliseconds. In some embodiments, measurement rate for post-contact temperature may be dynamically determined based on a number of factors including, for example, battery level, rate of change in the recently measured post-contact temperature, and/or variance of the measured post-contact temperature. For example, temperature sensor  106  may increase the measurement rate for post-contact temperature when the variance of the post-contact temperature measured in the last few minutes are above a threshold variance (e.g., 20%). In another example, temperature sensor  106  may increase the measurement rate for post-contact temperature when the last several measured post-contact temperatures show a sharp increase/decrease (e.g., 2 F/sec). In yet another example, temperature sensor  106  may decrease the measurement rate for post-contact temperature when drug delivery device  100  has less than, for example, −25% battery level. 
     In some embodiments, a measurement rate of post-contact temperature may be lower than a measurement rate of contact temperature. In some embodiments, a measurement rate/timing of post-contact temperature may be the same, or substantially the same, as a measurement rate/timing for ambient temperature. 
     The processes above are described as being performed by temperature sensor  106  (e.g., determining measurement timing/scheme, taking a measurement, identifying ambient/contact/post-contact temperature measurements). However, in some embodiments, the processes may be at least partially performed, or enabled, by one or more processors that may be internal and/or external to temperature sensor  106 . That is, one or more processors may be configured to perform the above-described processes at least partially and/or enable temperature sensor  106  to perform them. Further, one or more of such processors may be shared among components of drug delivery device  100 . 
     Identifying Living Being/Inanimate Object 
     In the example of  FIG. 1 , drug delivery device  100 , based on the measured temperatures (e.g., ambient temperature, contact temperature, and/or post-contact temperature), may determine whether a target object was a living being or an inanimate object. In some embodiments, drug delivery device  100  may determine whether a target object was a living being or an inanimate object further based on data generated by contact sensor  104  (e.g., raw sensor data or data indicative of whether contact sensor  104  is in contact with an object). 
     In some embodiments, drug delivery device  100  may determine whether a target object was a living being or an inanimate object further based temperature context data (generated by contact sensor  104  or one or more processors). As discussed above, temperature context data may include, for example, data that may be used to determine which portion of the temperature data is ambient temperature (i.e., temperature before contact sensor  104  is in contact with an object), which portion of the temperature data is contact temperature (i.e., temperature while contact sensor  104  is in contact with the object), and which portion of the temperature data is post-contact temperature (i.e., temperature when contact sensor  104  is no longer in contact with the object). In one example, the temperature context data may include time/date corresponding to when ambient temperature ends, contact temperature begins/ends, and/or when post-contact temperature begins/ends. In another example, temperature context data may identify temperature measurements corresponding to (i) the first and/or last ambient temperature measurements, (ii) the first and/or last contact temperature measurements, and/or (iii) the first and/or last post-contact temperature measurements. 
     In some embodiments, drug delivery device  100  may transmit the measured temperature to an external device, and the external device may analyze the measured temperature to determine whether a target object was a living being or an inanimate object. Alternatively, or additionally, drug delivery device  100  transmit the measured temperature to an external device, and the external device may partially analyze the measured temperature and transmit the result of the analysis back to drug delivery device  100 . In response, drug delivery device  100  may complete the analysis to determine whether a target object was a living being or an inanimate object. 
     In some embodiments, drug delivery device  100  determines whether a target object of a dose was a living being or an inanimate object after each dose. Alternatively, drug delivery device  100  determine, in batch, whether target objects of a plurality of doses are a living being or an inanimate object. 
     In some embodiments, after the dose is delivered, drug delivery device  100  may record that a dose is delivered. In some embodiments, the record may include, for example, time/date when the dose was delivered, identification of the substance, identification of container  110 , volume of the dose inside container  110 , volume of the dose delivered while contact sensor  104  is activated. The record may further include whether the dose was likely delivered to a living being or an inanimate object. In some embodiments, drug delivery device  100  may transmit the record(s) to an external device (e.g., patient&#39;s mobile device, a cloud-based application, a “smart” case for device  100 ). 
     In some embodiments, drug delivery device  100 , based on measured ambient temperature and/or post-contact temperature, calibrates the contact temperature prior to using the contact temperature to determine whether a target object was a living being or an inanimate object. In some embodiments, drug delivery device  100  may use a predetermined ratio(s) that quantitatively describes the relationship between (i) ambient and/or post-contact temperature and (ii) the contact temperature. For example, for every 1° F. below 80° F. that an ambient and/or post-contact temperature drops, the contact temperature may be expected to drop 0.25° F. In these embodiments, a contact temperature of 82° F. would not register as a living being when the ambient and/or post-contact temperature was 75° F. But, a contact temperature of 82° F. would be registered as a living being when the ambient and/or post-contact temperature was 60° F. 
       FIG. 2  illustrates various hardware components of drug delivery device  100  of  FIG. 1 . As discussed above, drug delivery device  100  includes delivery apparatus  102 , contact sensor  104 , and temperature sensor  106 . As shown in  FIG. 2 , drug delivery device  100  may further include one or more processors  202 , and a transmitter  204 . Although not shown in  FIG. 2 , drug delivery device  100  may further include one of more of the following components: battery, receiver (or transceiver), RFID tag/transmitter (e.g., for identifying device  100 , container  110 , and/or delivery apparatus  102 ), a needle cap, LED display, motion sensor(s) (e.g. accelerometer, magnetometer, gyroscope), temperature sensor for measuring temperature of the substance in container  110 . 
     As discussed above, processors  202  may be configured to at least partially perform and/or enable one or more functionalities of components such as delivery apparatus  102 , contact sensor  104 , and temperature sensor  106 . Processors  202  may be further configured to transmit, using transmitter  204 , a communication  220  to an external device  210 . In some embodiments, one or more processors  202  may be a part of contact sensor  104 , temperature sensor  106 , and/or delivery apparatus  102 . In some embodiments, processors  202  may include an analog and/or digital circuit for processing signal generated and/or received by contact sensor  104 , temperature sensor  106 , and/or delivery apparatus  102 . For example, processors  202  may include thresholding circuit(s), signal conditioning circuit(s), and/or analog-to-digital and/or digital-to-analog converter(s). 
     In  FIG. 2 , communication  220  may include data that can be used by external device  210  to determine whether a target dose(s) is likely a living being or an inanimate object. In some embodiments, communication  220  may include measured temperature  222 . For example, communication  220  may include contact temperature measured by temperature sensor  106 . In another example, communication  220  may include contact temperature as well as ambient temperature and/or post-contact temperature measured by temperature sensor  106 . In yet another example, communication  220  may include contact temperature as well as a stabilized portion of post-contact temperature measured by temperature sensor  106 . In some embodiments, communication  220  may further include temperature context data  224 . As discussed above, temperature context data  224  may be used to identify which portion of measured temperature  222  corresponds to ambient temperature, contact temperature, and/or post-contact temperature. In some embodiments, temperature context data  224  may identify which portion of measured temperature  222  corresponds to a stabilized portion of post-context temperature. 
     In some embodiments, each measurement included in measured temperature  222  may be associated with data (e.g., a timestamp) indicative of when the measurement was taken. In some embodiments, each measurement included in measured temperature  222  may be associated with data indicative of when the measurement was taken with respect to when delivery apparatus  102  is activated and/or deactivated. 
     In some embodiments, communication  220  may further include data generated by contact sensor  104  (e.g., data generated during contact, data that was used to determine that contact sensor  104  is or is not in contact with an object). 
     In some embodiments, communication  220  may further include data associated with one or more doses delivered by drug delivery device  100 , such as a volume of a dose, identification of the substance, identification of a patient associated with device  100 , and time/date when the dose was delivered. 
     Communication  220  may be transmitted (i) after a dose is delivered, (ii) after a predetermined number of doses have been delivered, (iii) based on a predetermined schedule, (iv) based on an input from a user (e.g., after a user presses a button on drug delivery device  100 ), and/or (v) based on a request from an external device (e.g., external device  210 ). 
     External device  210 , based on data included in communication  220 , may determine whether the target object to which a dose delivered by drug delivery device  100  was indeed a living human being. Alternatively, or additionally, external device  210  may partially analyze the measured temperature and transmit the result of the analysis back to drug delivery device  100 . In response, drug delivery device  100  may complete the analysis to determine whether the target object was a living being or an inanimate object. 
     Transmitter  204  may include a wired and/or a wireless transmitter(s). For example, transmitter  204  may include a Bluetooth transmitter, a near-field communication (NFC) transmitter, or a cellular transmitter (e.g. LTE). 
     In some embodiments, external device  210  may be a mobile device, for example, operated by patient  120  or a healthcare professional. In some embodiments, external device  210  may be a dedicated device is paired with external device  210 . In some embodiments, external device  210  may be capable of encasing drug delivery device  100  when not in use. In some embodiments, external device  210  may a implemented on a cloud platform. 
       FIG. 3  illustrates an example of a drug delivery device  100  in accordance with the disclosed embodiments. As shown in  FIG. 3 , drug delivery device  100  may have a cylinder-like structure, and contact sensor  104  and temperature sensor  106  may be disposed on the needle-end of the cylinder-like structure. In particular, a sensing surface of contact sensor  104  may have a ring shape. Further, a sensing surface of temperature sensor  106  may be disposed within the ring-shaped sensing surface of contact sensor  104 . In  FIG. 3 , needle  112  is in a retracted state; needle  112  may extend (e.g., after delivery apparatus  102  activates) through the center of the ring shape. In some embodiments, a sensing surface of temperature sensor  106  may have a ring shape, and a sensing surface of contact sensor  104  may be disposed within the sensing surface of the temperature sensor  106 . 
       FIGS. 4-7  illustrate additional examples of arrangements for sensing surfaces in accordance with the disclosed embodiments. In  FIG. 4 , contact sensor  104  and temperature sensor  106 , as a collective, may form a ring shape. A portion of the ring (e.g., half of the ring) may be a surface of contact sensor  104 , and another portion of the ring may be a surface of temperature sensor  104 . Needle  112  may be disposed, or extend through, the center of the ring. In  FIG. 5 , sensing surfaces of contact sensor  104  and temperature sensor  106  may be separated by a needle. Thus, in  FIG. 5 , a sensing surface of a contact sensor  104  may be disposed substantially proximate to a sensing surface of temperature sensor  106 . In  FIG. 6 , sensing surfaces of contact sensor  104  and temperature sensor  106  may be adjacent to each other. The sensing surfaces may also be adjacent to needle  112 . In  FIG. 7 , a sensing surface of a contact sensor  104  forms an inner ring while a sensing surface of temperature sensor  106  forms an outer ring. The centers of the rings may be aligned. Needle  112  may be disposed, or extend through, the center of both rings. 
     In some embodiments, contact sensor  104  may include a mechanical pressure sensor, and temperature sensor  106  may be arranged such that temperature sensor  106  comes in contact with an object after the mechanical pressure sensor  104  becomes compressed upon contact with the object. In some embodiments, contact sensor  104  and temperature sensor  106  may be arranged such that both sensors come in contact with an object substantially at the same time. For example, a sensing surface of contact sensor  104  and a sensing surface of temperature sensor  106  may be at substantially the same level. 
       FIGS. 8-10  are example graphs illustrating temperature measured by temperature sensor  106  before, during, and after contact sensor  104  is in contact with an object. 
       FIG. 8  illustrates an example graph  800  illustrating temperature measured by temperature sensor  106  around a time period when drug delivery device  100  delivers a dose to a living patient  120 . In  FIG. 8 , prior to t 1 , the measured temperature is steady (i.e., low variance) at room temperature. The temperature measured during this time may be considered ambient temperature. 
     At t 1 , contact sensor  104  and temperature sensor  106  come in contact with the abdomen of patient  120 . Thus, the measured temperature begins to rapidly increase at an expected rate (e.g., 75° F. to 92° F. over 3 seconds). 
     At t 2 , delivery apparatus  102  is activated, and delivery apparatus  102  begins delivering a dose into the arm of patient  120 . A delay between t 1  and t 2  may be due to the time taken for contact sensor  104  (or a processor) to determine that contact sensor  104  is indeed in contact with an object. For example, contact sensor  104  may wait until the measured pressure/conductivity stabilizes before determining that contact sensor  104  is in contact with an object. Alternatively, or additionally, there may be an intentional delay between t 1  and t 2 , for example, to ensure that patient  120  is ready/emotionally ready for the injection. In some embodiments, t 1  and t 2  may be the same. That is, delivery apparatus  102  may be activated as soon as contact sensor  104  is in contact with an object. In between t 2  and t 3 , the measured temperature may be affected primarily by two variables: temperature of the substance and ambient temperature. In the example of  FIG. 8 , the substance in container  110  is at room temperature. But, if the substance in container  110  was at refrigerated temperatures, the measured temperature may decrease at an expected rate as the injection site is cooled by the refrigerated substance. In the example of  FIG. 8 , one or more pieces of clothing covering the contact area (abdomen) have been removed immediately, and exposure to the ambient temperature decreases the measured temperature. At least for these reasons, the measured temperature may increase at a slower, expected rate and/or decrease at an expected rate while the dose is being delivered into patient (e.g., 92° F. to 89° F. over 10 seconds). 
     At t 3 , a dose is delivered and patient  120  may disengage drug delivery device  100  from the abdomen. Thus, the measured temperature begins to decrease. 
     At t 4 , contact sensor  104  determines that contact sensor  104  is no longer in contact with an object. Any delay between t 3  and t 4  may be due to the time taken for contact sensor  104  (or a processor) to determine that contact sensor  104  is no longer in contact with an object. For example, contact sensor  104  may wait until the measured pressure/conductivity stabilizes before determining that contact sensor  104  is no longer in contact with an object. In some embodiments, t 3  and t 4  may be the same. That is, delivery apparatus  102  may be deactivated immediately after contact sensor  104  disengages with the object. 
     At t 5 , the measured temperature may reach the previously measured ambient temperature prior to t 1 . In some embodiments, the measured temperature between t 3  and t 5  may be used to calibrate the measured temperature between t 1 /t 2  and t 3 /t 4 . In some embodiments, the measured temperature after t 5  may be used to calibrate the measured temperature between t 1 /t 2  and t 3 /t 4 . In some embodiments, the measured temperature before t 1  may be used to calibrate the measured temperature between t 1 /t 2  and t 3 /t 4 . In some embodiments, calibration may involve using a predetermined ratio(s) that quantitatively describes the relationship between (i) ambient (t 1 ) and/or post-contact (t 5 ) temperature and (ii) the contact temperature (t 1 -t 3 ). For example, for every 1 F.° below 80F.° that an ambient and/or post-contact temperature drops, the contact temperature is expected to drop 0.25 F.°. Therefore, a contact temperature of 82 F.° would not register as a living being when the ambient and/or post-contact temperature was 75 F°. But, a contact temperature of 82 F.° would be registered as a living being when the ambient and/or post-contact temperature was 60 F.°. 
     In the example of  FIG. 8 , drug delivery device  100  or an external device may determine that the target object was a living being because the rates of temperature increase and/or decrease after t 2  were at expected rates. Moreover, ambient temperature measure prior to t 1  or measured temperature after t 5  may be used to calibrate the contact temperature (i.e., between t 1 /t 2  and t 3 /t 4 ). 
       FIG. 9  illustrates another example graph  900  illustrating temperature measured by temperature sensor  106  around a time period when drug delivery device  100  delivers a dose to a living patient  120 .  FIG. 9  is similar to  FIG. 8 , except that patient  120  of  FIG. 9  may have applied ice to the contact area before device  100 /contact sensor  104  comes in contact with patient  120 . 
     Accordingly, when contact sensor  104  and/or temperature sensor  106  come in contact with the abdomen of patient  120  at t 1 , the measured temperature begins to decrease at an expected rate for an iced contact (e.g., 75° F. to 62° F. over 3 seconds) as the temperature sensor reaches equilibrium with the temperature of the iced contact site. Furthermore, in contrast to the example of  FIG. 8 , the measured temperature then begins to increase at another expected rate as the iced area begins to warm (e.g., 62° F. to 71° F. over 15 seconds). 
     In the example of  FIG. 9 , drug delivery device  100  or an external device may determine that the target object was a living being and that the delivery area was an iced area because the rates of temperature decrease and subsequent increase after t 1  were at expected rates for an iced area of a living being. The rate of the increase after t 1  may be especially important for determining that the target object was a living being because body heat will cause the measured temperature of the contact site to increase faster than an inanimate object that was iced or taken out of the refrigerator. 
     The expected rates and/or values may be predetermined. For example, a vendor/manufacturer of drug delivery device  100  may conduct experiments to determine the expected rates and/or values. In some embodiments, the multiple set of expected rates and/or values may be determined, each set being associated with a particular injection site (e.g., arm, thigh, abdomen). In some embodiments, each set may be associated with a different body size and/or composition. For example, a set of expected rates and/or values may be determined for a person having a relatively high body fat percentage while another set of expected rates and/or values may be determined for a person having a relatively low body fat percentage. In some embodiments, a set of expected rates and/or values may be associated with a particular substance in container  110 . For example, certain substances that may cause inflammation/increase in skin temperature may have a different set of expected rates and/or values than substances that do not cause inflammation/increase in skin temperature. In some embodiments, the expected rates and/or values may be associated with a particular person. 
     In some embodiments, the expected rates and/or values may be determined based on historical temperature measurements received from a plurality of drug delivery devices. In such embodiments, statistical analysis may be applied to define a series of expected rates and values. For example, drug delivery events that have a set of rates and values similar to  FIG. 8  would be categorized as non-iced sites, and events that have a set of rates and values similar to  FIG. 9  would be categorized as iced sites. In some embodiments, further statistical analysis would be applied to create a quantitative range of contact temperature over time, for each category. In some embodiments, statistical analysis is applied to create a quantitative range for specific timepoints, such as t 1 , or time ranges, such as t 1 -t 3 . By creating quantitative ranges, outliers and anomalies can be identified, and drug delivery events previously labeled as living being can be corrected and labeled as inanimate objects. In some embodiments, the quantitative ranges are created using calibrated contact temperature measurements, correcting for variance in ambient temperature. In some embodiments, the expected rates and/or values may be determined based on historical, temperature measurements received from a particular drug delivery device  100 . In such embodiments, statistical analysis may be applied to create an intrapersonal quantitative range of contact temperature over time, in order to identify anomalies that differ from the patient&#39;s normal injection routine. 
       FIG. 10  illustrates yet another example graph illustrating temperature measure by temperature sensor  106  when drug delivery device  100  delivers a dose to an inanimate object (e.g., orange or wet paper towel). In  FIG. 10 , the measured temperature remains at, or substantially near, the ambient temperature. Thus, drug delivery device  100  or an external device may determine that the target object was an inanimate object because the rates of temperature change after t 1  were not at the expected rates. 
       FIG. 11  illustrates an example of a process  1100  for delivering a dose of a substance to a living being by a drug delivery device  100  in accordance with the disclosed embodiments. 
     At a step  1102 , contact sensor  104 , or a processor using contact sensor  104 , may determine whether the device is in contact with an object. 
     At a step  1104 , contact sensor  104 , or a processor using contact sensor  104 , may activate delivery apparatus  102  after determining that the device  100  or a sensing surface of contact sensor  104  is in contact with the object. The activation of delivery apparatus  102  may cause delivery apparatus  102  to deliver a dose of the substance to the object, for example, by actuating actuator  108  to push on a plunger of a container  110  that include the substance. 
     At a step  1106 , temperature sensor  106 , or a processor using temperature sensor  106 , may measure temperature of the object. In some embodiments, the measured temperature may include a plurality of measurements. In some embodiments, measuring of the temperature of the object may include measuring the temperature of the object periodically and/or based on a predetermined measurement timing scheme. 
     At an optional step, temperature sensor  106 , or a processor using temperature sensor  106 , may measure temperature before the delivery apparatus is activated and/or temperature after the delivery apparatus is deactivated. In some embodiments, the measured temperature of the object may be calibrated by the temperature before the delivery apparatus is activated and/or the temperature after the delivery apparatus is deactivated. 
     At an optional step, contact sensor  104 , or a processor using contact sensor  104 , may deactivate delivery apparatus  102  after determining that the device  100  or a sensing surface of contact sensor  104  is no longer in contact with the object 
     At an optional step, a transmitter, or a processor using the transmitter, may transmit a communication to an external device. The communication may include the measured temperature. 
     At a step  1108 , the external device, in response to receiving the communication, may determine whether the object was a living being based on the measured temperature. Alternatively, a processor of drug delivery device  100  may determine whether the object was a living being based on the measured temperature. In some embodiments, the determination of whether the object was a living being may include comparing the measured temperature with data generated based on previously measured temperatures transmitted by one or more drug delivery devices or a particular drug delivery device. In some embodiments, the determination of whether the object was a living being may include comparing a rate of temperature change after the delivery apparatus is activated with an expected rate of temperature change. In some embodiments, the determination of whether the object was a living being may include determining whether the measured temperature changed at least by a predetermined amount after the delivery apparatus is activated. 
     At a step  1110 , the external device or a processor of drug delivery device  100  may record that a dose of the substance has been delivered successfully after determining that the object was a living being. 
     At an optional step, contact sensor  104 , delivery apparatus  102 , and/or a processor of drug delivery device  100  may be configured to deactivate the delivery apparatus  102  after determining that the device  100  or a sensing surface of contact sensor  104  is no longer in contact with the object. 
     In some embodiments, delivery apparatus  102  may be configured to deliver the dose of the substance to a delivery site of the object. In these embodiments, the contact sensor, the temperature sensor, and the delivery apparatus may be substantially proximate to each other such that, when the delivery apparatus is activated, the contact sensor determines whether the contact sensor is in contact with the delivery site of the object and the temperature sensor measures temperature at the delivery site of the object. 
     From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but that various modifications may be made without deviating from the scope of the invention. Accordingly, the invention is not limited except as by the appended claims.