Abstract:
A medication injection supervisor device, in one example embodiment, comprises a particular sleeve, the particular sleeve being designed to lock onto to a prefabricated injection pen of a particular design, a universal header designed slide onto the particular sleeve irrespective of the particular model of the prefabricated injection pen, an electronics assembly housed by the universal header, a sensor to detect an injection automatically, the sensor being communicatively coupled to the electronics assembly, a display to display injection data, and a button to allow manipulation and display of the injection data, including resetting of the time. The medication injection supervisor device can infer the completion of the injection from a plunger of the injection pen being depressed.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional of Non-Provisional Application 12/724,411 filed on Mar. 15, 2010, which is incorporated herein by reference. This application also claims the benefit of the filing date of Provisional Application 61/175,810 filed on May 6, 2009, which is incorporated herein by reference. 
     
    
     FIELD 
       [0002]    The present invention relates generally to devices for management of chronic medical conditions requiring periodic administration of medications by self injection. More specifically, the present invention relates to an assembly adaptable to a variety of medication injection delivery devices. 
       BACKGROUND 
       [0003]    To maintain optimum conditions, a patient suffering from a chronic medical condition is required to conform to a prescribed administration schedule of a medication, adhere to a prescribed dosage, avoid extra administrations, avoid missed administrations, and adhere to various recommended health and safety best practices. 
         [0004]    The long-term health of the patient with a chronic medical condition depends on the day-to-day management of the condition. Mismanagement of the condition can result in significant morbidity and mortality and carry an increased risk of developing complications. Focused approach to management of a chronic medical condition is essential for the patient, in order to reduce the occurrence of these complications. 
         [0005]    For example, diabetes occurs when the body does not produce enough insulin resulting for many diabetics in a requirement of a periodic insulin injection to control glucose levels in the body. One of the dangers associated with controlling glucose levels with insulin is insulin overdose. Symptoms of an insulin overdose reflect low blood sugar levels (hypoglycemia) and can include headache, irregular heartbeat, increased heart rate or pulse, sweating, tremor, nausea, increased hunger, and anxiety. 
         [0006]    An insulin dependent diabetic needs to keep accurate track of the type and amount of insulin he is injecting. Individual insulin products are numerous, but currently insulin may be divided into four major types: 1) Short-acting insulin, which is soluble and acts quickly (within 30-60 minutes) and lasts between 6 and 8 hours. Some subtypes of this soluble insulin may act faster and last for a shorter time. 2) Intermediate-acting insulin-isophane insulin, which acts slightly more slowly (within 1-2 hours) and lasts between 10 and 14 hours. 3) Long-acting insulin such as determir, glargine, protamine zinc, and zinc suspension, which acts comparatively slowly (1-2 hours) and lasts comparatively much longer, for up to 24 hours. 4) Various mixtures of the above-mentioned three major types of insulin. Different amounts of the short and intermediate-acting insulin can be mixed together depending on the requirements of an individual case. A user can suffer long-term health consequences if too little insulin is taken. If, on the other hand, too much insulin is taken, the user can suffer immediate hypoglycemia leading to coma and hospitalization. 
       SUMMARY 
       [0007]    This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. 
         [0008]    A medication injection supervisor device, in one example embodiment, comprises a particular sleeve, the particular sleeve being designed to rigidly lock onto to a prefabricated injection pen of a particular design, a universal header designed to rigidly lock onto the particular sleeve irrespective of the particular model of the prefabricated injection pen, an electronics assembly housed by the universal header, a sensor to detect an injection automatically, the sensor being communicatively coupled to the electronics assembly, a display to display injection data, and a button to allow manipulation and display of the injection data, including resetting the time. The medication injection supervisor device can infer the completion of the injection from depressing of a plunger of the injection pen. 
         [0009]    The medication injection supervisor device can further include a dosage reading system to read a dosage of medication delivered by the prefabrication injection pen, the dosage reading system including a clip specific to the prefabricated injection pen coupled to a plunger of the prefabricated injection pen, the dosage being determined by a position of the clip after an injection. The medication injection supervisor device can further include a micro optics subsystem communicatively coupled to the electronics assembly and having a dial reader to take one or more images of a dosage dial of the prefabricated injection pen, and an imaging subsystem communicatively coupled to the electronics assembly to recognize characters in the images taken by the dial reader. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0010]    Example embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which: 
           [0011]      FIG. 1  is a perspective view of a medication injection supervisor device, in accordance with an example embodiment; 
           [0012]      FIG. 2  shows the measurement history of a medication injection supervisor device, in accordance with an example embodiment; 
           [0013]      FIG. 3  shows various messages that may appear on the display screen of a medication injection supervisor device, in accordance with an example embodiment; 
           [0014]      FIG. 4  is a perspective view of plunger break or locking pin device of a medication injection supervisor device, in accordance with an example embodiment; 
           [0015]      FIG. 5  is a perspective view of a medication injection supervisor device mounted on an injection pen, in accordance with an example embodiment; 
           [0016]      FIG. 6  is an inverted view of a universal header, in accordance with an example embodiment; 
           [0017]      FIG. 7  is a sleeve specific to an injection pen model, in accordance with an example embodiment; 
           [0018]      FIG. 8  is a universal header being mounted on a sleeve, in accordance with an example embodiment; 
           [0019]      FIG. 9  is a universal header mounted on a sleeve, in accordance with an example embodiment; 
           [0020]      FIG. 10  is an empty universal header and sleeve assembly mounted on an injection pen with locking indents visible, in accordance with an example embodiment; 
           [0021]      FIG. 11  is an exploded view of an medication injection supervisor device, in accordance with an example embodiment; 
           [0022]      FIG. 12  shows a sleeve being mounted on a Sanofi Aventis Lantus SoloStar injection pen, in accordance with an example embodiment; 
           [0023]      FIG. 13  shows a universal header being installed on a sleeve mounted on a Sanofi Aventis Lantus SoloStar injection pen, in accordance with an example embodiment; 
           [0024]      FIG. 14  shows a sleeve being mounted on a Novo Nordisk FlexPen injection pen, in accordance with an example embodiment; 
           [0025]      FIG. 15  shows a universal header being installed on a sleeve mounted on a Novo Nordisk FlexPen injection pen, in accordance with an example embodiment; 
           [0026]      FIG. 16  is a flow diagram showing a method for supervising injections using the medication injection supervising device, in accordance with an example embodiment; 
           [0027]      FIG. 17  shows a readable plunger subsystem, in accordance with an example embodiment; and 
           [0028]      FIG. 18  shows a micro optics and imaging system, in accordance with an example embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show illustrations in accordance with example embodiments. These example embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the present subject matter. The embodiments can be combined, and other embodiments can be formed by introducing structural, logical or electrical changes without departing from the scope of what is claimed. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined by the appended claims and their equivalents. 
         [0030]    In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one. In this document, the term “or” is used to refer to a nonexclusive “or,” such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls. 
         [0031]    In the example embodiments described herein, the medication injection supervisor device is an attachment to a standard injection pen, which is sufficiently small to be carried by patients in a pocket or a purse. The medication injection supervisor device can allow patients to keep accurate injection records. In addition to providing a method for keeping one&#39;s medication injection records, the medication injection supervisor device can provide reminders and other warnings about events that may affect patient&#39;s health. 
         [0032]    In some example embodiments, the medication injection supervisor device can record events and generate reports to spot trends and patterns so that adjustments can be made to medication dosage, exercise, or eating. This kind of record keeping can provide someone with a chronic medical condition with a long-term view of his disease that will in turn help him control the disease and lead a healthier life without complications therefrom. 
         [0033]    The medication injection supervisor device, according to an example embodiment, can be mounted on a variety of prefabricated injection pens to record the time since last injection. The device can automatically trigger whenever the user injects the medication and thus can provide a reliable means to note the time elapsed since the last injection. Prefabricated injection pens can be of various shapes, depending on the manufacturer. To accommodate these various shapes, a two-part attachment method can be used. The first part can be a sleeve designed to lock solidly and robustly on the particular injection pen. The second part can be a universal header attached to the sleeve unit and housing the electronics. 
         [0034]      FIG. 1  is a perspective view of a medication injection supervisor device  100 , in accordance with an example embodiment. As shown in  FIG. 1 , the medication injection supervisor device  100  includes a sleeve  120  and a universal header  130 . An injection pen  110  is prefabricated and is not a part of the medication injection supervisor device  100 . The injection pen  110  can include a plunger  112 , which can be extended to dial a medication dosage. The universal header  130  can include a display  132  to display various data related to medication injection supervision. For example, as shown in  FIG. 1 , the display  132  can display the time since last injection. The universal header  130  can also include one or more buttons  134  to allow the user to manipulate and display the data related to medication injection supervision. 
         [0035]    In some example embodiments, the one or more buttons  134  can be used to turn on the display  132 . In some example embodiments, it is not necessary to utilize the one or more buttons  134  to turn off the display  132 , which turns off automatically after a certain period of time. In some example embodiments, the display  132  does not display the time of day, as the time displayed is elapsed time only. Furthermore, there is no requirement for start and end times of injections to be displayed. 
         [0036]    As shown in  FIG. 1 , the sleeve  120  is adapted to the injection pen  110  and the universal header  130  is locked onto the sleeve  120  at locking indents (not shown). This approach allows the universal header  130  to be mounted on a variety of existing injection pens. Thus, the medication injection supervisor device  100  facilitates a two-part attachment method, wherein the sleeve  120  is customized to fit a specific model of an injection pen. This allows the universal header  130  that houses the electronics to be used on a variety of injection pens. Additionally, this allows easy attachment and removal of the medication injection supervisor device  100 , and for its precise positioning for various injection pen types without complex steps. In some example embodiments, the medication injection supervisor device  100  is fully automatic and requires no user input so that there is no need to confirm any action and/or to record an event. 
         [0037]    The medication injection supervisor device  100  can be characterized as a clip-on injection recorder that attaches to the injection  110  pen to assist in maintaining optimum patient control. The medication injection supervisor device  100  is a clip-on designed to fit an injection pen of a specific brand. The header  130 , shown in  FIG. 1  can be robust enough for regular use and simple enough for very young children and the elderly to fit and remove. The design of the medication injection supervisor device  100  is slim and lightweight so as not to increase the total bulkiness of the injection pen  110  significantly. 
         [0038]      FIG. 2  shows the measurement history of the medication injection supervisor device  100 , in accordance with an example embodiment. As shown in  FIG. 2 , the medication injection supervisor device  100  can record the dosage and time of each injection ( 202 ,  204 , and  206 ) along with any warnings over a predetermined period of time. For example, for regular usage there can be up to four readings a day for thirty days. A user can have the ability to set up to four injection times and tolerances, these being the “scheduled” times the user is due to inject. 
         [0039]      FIG. 3  shows various messages that may appear on the display  132  of the medication injection supervisor device  100 , in accordance with an example embodiment. The display  132 , as shown in  FIG. 3 , allows the user to step through the memory of recorded values directly from the medication injection supervisor device  100  as well as any warnings or messages. The medication injection supervisor device  100  has the ability to issue an alarm in both an auditory and a visual manner after the occurrence of one or more of the following: a missed injection, an injection dosage outside of the expected range, and a “double” injection. The medication injection supervisor device  100  can also check for and detect certain situations where a warning is to be provided. For example, the medication injection supervisor device  100  can warn when the cartridge of the medication pen  110  is low or the pen temperature has exceeded recommended safe range for the medication. The alarm may also be used to provide an alert, a reminder, or other scheduled event such as an “injection due” reminder or a reminder to change the needle after a given number of injections or uses. 
         [0040]    The alarm features of the medication injection supervisor device  100  can address all of these points in a way that extends the basic ideal of a simple alarm. In this regard, the device can learn from a past usage pattern and can start to predict optimum injection times and suggest dosage. Thus, the device can monitor for dangerous usage, e.g. injecting a larger than recommended dosage or multiple dosages in a too-short period of time. 
         [0041]    The device can also be comprised of a built-in SMS capability to automatically send injection usage to a “carer”, to allow remote confirmation and monitoring for parents of young children as well as those looking after the elderly, to send general summary information concerning daily or weekly usage to nominated numbers, and to send real-time emergency SMS text messages to report “double dosage” to inform of a potential risk. 
         [0042]      FIG. 4  is a perspective view of a plunger break or locking pin device of the medication injection supervisor device  100 , in accordance with an example embodiment. In some example embodiments, when the medication injection supervisor device  100  detects a “dangerous situation” (e.g. a too high a dose) not only can it generate an auditory and visual alarm, but it can also activate a locking pin as shown in  FIG. 4  that will prevent the user from pressing the plunger  112 . This pin can be spring loaded and designed such that the user must dial a lower dose before the pin is released and the user allowed to proceed with the injection. 
         [0043]    The medication injection supervisor device  100  may also include an interface to download data to and configure the device from a Personal Computer (PC). As the user builds up usage information over a number of weeks, this data is analyzed via separate software on the PC to produce trend information. This can be used to allow the user to “optimize” his medication usage, and is “fed back” into the pen to suggest the “expected” dosage and warn if the user is deviating significantly from it. This information can also be used by a medical practitioner to analyze any change in the user&#39;s condition. 
         [0044]    The SMS functionality can allow a third party to be informed of any potentially dangerous situations concerning medication levels and generally, to allow monitoring whether the medication user is keeping to his recommended routine. This can be important when looking after young children and the elderly. The SMS feature can be extended further to allow text messages to be sent to the injection pen  110  to be displayed to the user on the display  132  should the usage data that has been downloaded indicate that a change in routine is required. 
         [0045]    In some example embodiments, the user can step through the memory of recorded values, warnings, and messages directly from the device using the one ore more buttons  134 . The device can have the ability to alarm in both an auditory and visual manner after the occurrence of missed injections, injection dosages being outside the expected range, and “double” injections. The device can also check for and detect certain situations where a warning is to be provided. For example, the device can warn when the cartridge is low or the pen temperature has exceeded its recommended safe range for medication. 
         [0046]    In some example embodiments, the alarm may also be used to provide an alert for reminders or other scheduled events such as an “injection due” reminder and a reminder to change the injection pen&#39;s needle after a given number of injections or uses. Furthermore, the device can learn from a past usage pattern and can start predicting optimum injection times and suggest dosage amounts. Additionally, the device can monitor for dangerous usage, e.g. injecting a larger than recommended dosage or multiple dosages in a too-short period of time. 
         [0047]    In some example embodiments, the device can facilitate remote monitoring of the patient&#39;s condition by sending information wirelessly. For example, the device can send information concerning injection usage to allow remote confirmation and monitoring to parents of young children and those who care for the elderly, send general summary information on daily or weekly usage to nominated numbers, and send instant emergency messages to report “double dosage” to inform of a potential risk. 
         [0048]    In some example embodiments, the device can include an interface for downloading data to configure the device. As the user builds up usage information over a period of time, this data can be analyzed via separate software on a computing device to produce trend information. This information can be used to enable the user to optimize his medication usage, and can be fed back into the pen to suggest a dosage, and warn if the user&#39;s usage is deviating significantly. 
         [0049]      FIG. 5  is a perspective view of the medication injection supervisor device  100  installed on the injection pen  110 , in accordance with an example embodiment. As shown the medication injection supervisor device  100  can include the sleeve  120  and the universal header  130 . The universal header  130  can, in turn, include the display  132  and the one or more buttons  134 . The universal header  130  can be mounted on the sleeve  120  by sliding the universal header  130  on rails of the sleeve  120  designed to accommodate the universal header  130 . When the universal header  130  is so mounted, the sleeve  120  squeezes the injection pen  110  holding the medication injection supervisor device tightly in place. 
         [0050]    Thereafter, the medication injection supervisor device  100 , according to an example embodiment, can assist in the control of medication injections by recording, monitoring, recommending, reporting, and protecting a user. The medication injection supervisor device  100  can be small enough so one can easily carry it with him wherever he goes as an attachment to a standard injection pen. In addition to providing a quick and easy method of recording his medication injection history, a user can be provided with a reminder or a warning if those reading were fed into the universal header  130  so that adjustments can be made in medication, exercise, or eating. This approach can provide someone with a chronic condition with a long-term view of his disease that will in turn help him control the disease and lead a healthier life without complications related thereto. 
         [0051]    The medication injection supervisor device  100 , according to an example embodiment, may require no user input because there is no need to confirm any action or to record any event. Thus, the medication injection supervisor device  100  can be fully automated. The medication injection supervisor device  100  can include only one button, which is used to turn on the display  132 . The medication injection supervisor device  100  can record the dosage and time of each injection along with any warnings over a time period. It can have the ability to set a plurality of injection times and tolerances, which are the scheduled times the user is due to inject. 
         [0052]      FIG. 6  is an inverted view of the universal header  130 , in accordance with an example embodiment.  FIG. 7  is the sleeve specific to each injection pen model, in accordance with an example embodiment.  FIG. 8  is the universal header  130  being mounted on a specific sleeve, in accordance with an example embodiment.  FIG. 9  is the universal header  130  mounted on a specific sleeve assembly, in accordance with an example embodiment. The medication injection supervisor device  100  can be mounted on a variety of prefabricated injection pens to record the time since last injection. This information assists the user of the prefabricated injection pen in maintaining optimum diabetic control. 
         [0053]    The medication injection supervisor device  100  automatically triggers whenever the user injects, and thus provides a simple and reliable means to note the elapsed time since the last injection. The prefabricated injection pens can be of various shapes, depending on their respective manufacturers. To accommodate these various shapes, a two-part attachment method is used. The first part is a sleeve designed to lock solidly and robustly on the particular injection pen. The second part is a universal header unit attached to the sleeve that houses the electronics.  FIG. 10  is an empty universal header and specific sleeve assembly mounted on a specific injection pen model with the locking indents visible  136 , in accordance with an example embodiment. 
         [0054]      FIG. 11  is an exploded view of the medication injection supervisor device  100 , in accordance with an example embodiment. As shown, the medication injection supervisor device  100  can include a cover plate  138 , an electronic assembly  904 , a sensor  902 , a medication pen, the universal header  130 , and the sleeve  120 . In some example embodiments, when the medication injection supervisor device  100  is mounted on an injection pen  110 , it positions the sensor  902  over the edge of the plunger (not shown) of the injection pen  110 . In most injection pens, users extend the plunger to dial a dosage. When the plunger is extended, the sensor  902  (e.g. a micro switch) is toggled to the open state. When the sensor  902  is toggled to the open state, the timer is reset to zero to indicate that the injection has started. 
         [0055]    When the plunger is pressed to complete the injection, the sensor  902  is closed and the timer starts counting. In some example embodiments, a sound-generating unit (not shown) and/or a vibrational unit (not shown) can be installed to alert the user. It will be understood that some injection pens may not use a plunger to facilitate injections. Therefore, other techniques can be used to determine the occurrence of an injection and/or the dosage. For example, a micro optics and imaging system, as described below with reference to  FIG. 17  can be used to determine the occurrence of an injection and/or the dosage. 
         [0056]      FIG. 12  shows a sleeve being mounted on a Sanofi Aventis Lantus SoloStar medication pen, in accordance with an example embodiment.  FIG. 13  shows a universal header being installed on a sleeve mounted on a Sanofi Aventis Lantus SoloStar medication pen, in accordance with an example embodiment.  FIG. 14  shows a sleeve being mounted on a Novo Nordisk Flexpen medication pen, in accordance with an example embodiment.  FIG. 15  shows a universal header being installed on a sleeve mounted on a Novo Nordisk FlexPen medication pen, in accordance with an example embodiment. 
         [0057]      FIG. 16  is a flow diagram showing a method  1600  for supervising injections using the medication injection supervisor device, in accordance with an example embodiment. The method can commence at operation  1602  when the plunger  112  is in the down state. At decision block  1604  it can be determined whether or not the plunger  112  is raised. If the plunger  112  is raised at operation  1602  to dial a dosage, the method  1600  can proceeds to operation  1606  where the time display is reset to zero, thus starting the time count from the last injection. At operation  1608 , relevant environmental and usage data can be recorded. The relevant environmental and usage data can include time, date, temperature, dosage amount, and other sensor data. 
         [0058]    At decision block  1610 , it is determined based on the comparison of the recorded environmental and usage data to predetermined optimal values, whether or not an error notification needs to be issued. For example, if the time between injections is too short, an error can be communicated to the user. Thus, if at decision block  1610  it is determined that an error notification needs to be made, the method  1600  proceeds to operation  1612  where the error is displayed via the display  132 . In some example embodiments, other appropriate warning actions can be taken. For example, if the time interval between two consecutive injections is too short, vibrational and/or audio alerts can be activated. 
         [0059]    If, on the other hand, it is determined at decision block  1610  that no error notification needs to be made, the error is not communicated. In either case, the method  1600  can proceed and at decision block  1614  it can be determined whether the plunger  112  is depressed. If the plunger  112  is not depressed, the method  1600  remains in the idle mode waiting for the plunger  112  to be depressed. Once the plunger  112  is depressed, the method  1600  can proceed to operation  1618  where the display  132  can start measuring time from the last injection by showing the elapsed time. Additionally, a confirmation “beep” can be provided. 
         [0060]    At operation  1620 , visual indicators can be set to reinforce the status. For example, a section of the device can “glow” red for a predetermined time interval after the injection to indicate that it would be dangerous to inject again during this period. Once the predetermined time interval has elapsed, the “glow” can become green indicating that it is safe to inject again. Additionally, if the elapsed time is further exceeded past a point where another injection is expected but has not occurred the “glow” can change to yellow. 
         [0061]      FIG. 17  shows a readable plunger subsystem, in accordance with an example embodiment. As shown in  FIG. 17 , a secondary digitally readable plunger subsystem can be physically attached to the plunger head via a pen specific clip  1710  so that this secondary plunger moves in parallel with the injection pen plunger  112 . As the secondary plunger slides in and out of the universal header  130 , an electronics assembly inside the header  130  can read linear positions of the secondary plunger and thus infer the dosage of the medication. During the motion of the secondary plunger, the display  132  can show the user the inferred dosage for confirmation. The readings taken by the electronics assembly can be also used to time the occurrences of injections. 
         [0062]      FIG. 18  shows a micro optics and imaging system, in accordance with an example embodiment. As shown in  FIG. 18 , the micro optics and imaging system can be incorporated in the universal header  130 . The sleeve (not shown) can be designed to ensure that the universal header  130  is positioned over the physical dosage dial of the injection pen  110 . When the sensor (not shown) is triggered to indicate that an injection is about to start, an imaging system  1810  can be activated and an image recognition performed by reading the maximum dial value which is then stored in the memory of the medication injection supervisor device  100 . During the imaging sequence, the raw data can also be displayed on the display  132  to allow the user to the actual dial value. 
         [0063]    Thus, example embodiments of a medication injection supervisor device have been described. Although embodiments have been described with reference to specific example embodiments, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the system and method described herein. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.