JP2013521832A - Drug injection monitoring device - Google Patents

Abstract

  The drug infusion monitoring device in an exemplary embodiment includes a specific sleeve that is designed to lock onto a specific design of an off-the-shelf infusion pen, and a specific sleeve that is robust regardless of the specific model of the off-the-shelf infusion pen. A universal header designed to lock onto the electronic circuit assembly, an electronic circuit assembly housed by the universal header, a sensor communicatively coupled to the electronic circuit assembly and for automatically detecting injections; A display for displaying the infusion data and a button for enabling manipulation and display of the infusion data, including resetting the time. The drug injection monitoring device can infer completion of injection from the piston of the injection pen that is pushed. The drug infusion monitoring device may further comprise a dose reading system for reading the dose of drug delivered by the off-the-shelf infusion pen, which is coupled to the piston of the off-the-shelf infusion pen. Includes a pre-made injection pen specific clip, the dosage is determined by the position of the clip. A drug injection monitoring device is communicatively coupled to an electronic circuit assembly and includes a micro-optical subsystem having a scale plate reader for taking one or more images of a scale plate of a ready-made injection pen dose And an imaging subsystem communicatively coupled to the electronics assembly for recognizing features of the image taken by the scale reader.

Description

  The present invention relates generally to devices for managing chronic medical conditions that require periodic drug administration by self-infusion. More specifically, the present invention relates to an assembly that is adaptable to various drug infusion delivery devices.

  In order to maintain optimal conditions, patients suffering from chronic medical conditions should follow the prescribed drug dosing schedule, adhere to the prescribed dose, avoid additional doses, avoid missed doses, and various recommended health and safety It is necessary to adhere to the best practices.

  The long-term health of patients with chronic medical conditions depends on daily condition management. Condition management can increase morbidity and mortality, resulting in an increased risk of developing complications. Approaches that focus on the management of chronic conditions are extremely important for patients to reduce the incidence of these complications.

  For example, diabetes occurs when the body does not produce enough insulin, and many diabetics will be required to infuse insulin regularly to control blood glucose levels in the body. One of the risks associated with controlling blood sugar levels with insulin is insulin overdose. Signs of insulin overdose result in hypoglycemia (hypoglycemia) and may also include headache, arrhythmia, increased heart rate or pulse, sweating, shivering, nausea, increased hunger, and anxiety.

  Insulin dependent diabetes needs to continue to accurately track the type and amount of insulin being infused by the patient. Although there are many individual insulin products, currently insulin can be divided into four main types: 1) short-acting insulin, which is soluble and fast acting (30 Lasts for 6-8 hours). Some subtypes of this soluble insulin can act faster and last longer. 2) Intermediate acting insulin-isophen insulin, which acts slightly slower (within 1-2 hours) and lasts for 10-14 hours. 3) Long-acting insulins, such as detemir, glargine, protamine zinc, and zinc suspensions, which act relatively slowly (1-2 hours), relatively long, up to 24 hours Lasts for a while. 4) Various mixtures of the above three main types of insulin. Various amounts of short-acting insulin and intermediate-acting insulin may be mixed together as required by the individual case. Users may suffer from long-term health effects if too little insulin is taken. On the other hand, taking too much insulin can cause the user to suffer from immediate hypoglycemia, resulting in coma and hospitalization.

  This overview is provided that introduces a selection of concepts in a simplified form, 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 to help determine the scope of the claimed subject matter.

  The drug infusion monitoring device in one exemplary embodiment includes a specific sleeve designed to be securely locked to a specific design of an off-the-shelf infusion pen, and a specific sleeve regardless of the specific model of the off-the-shelf infusion pen Universal header designed to be firmly locked to the electronic circuit assembly, an electronic circuit assembly assembled by the universal header, and a sensor communicatively coupled to the electronic circuit assembly for automatically detecting injection And a display for displaying the infusion data and a button for enabling manipulation and display of the infusion data, including resetting the time. The drug injection monitoring device can infer completion of injection from pushing of the piston of the injection pen.

  The drug infusion monitoring device may further comprise a dose reading system for reading the dose of drug delivered by the off-the-shelf infusion pen, which is coupled to the piston of the off-the-shelf infusion pen. Including pre-made injection pen specific clips, the dosage is determined by the position of the clip after injection. A drug injection monitoring device is communicatively coupled to an electronic circuit assembly and includes a micro-optical subsystem having a scale plate reader for taking one or more images of a scale plate of a ready-made injection pen dose And an imaging subsystem communicatively coupled to the electronics assembly for recognizing features of the image taken by the scale reader.

  Illustrative embodiments are illustrated by non-limiting examples in the figures of the accompanying drawings, in which like reference numbers indicate like elements.

1 is a perspective view of a drug injection monitoring device according to an exemplary embodiment. FIG. It is a figure which shows the measurement log | history of the chemical | medical agent injection | pouring monitoring apparatus by one illustrative embodiment. FIG. 6 is a diagram illustrating various messages that may appear on a display screen of a drug infusion monitoring device according to an example embodiment. 1 is a perspective view of a piston break or lock pin device of a drug infusion monitoring device according to an exemplary embodiment. FIG. 1 is a perspective view of a drug injection monitoring device attached to an injection pen according to an exemplary embodiment. FIG. FIG. 6 is a flipped view of a universal header according to an exemplary embodiment. FIG. 2 is a model specific sleeve of an injection pen according to an exemplary embodiment. FIG. 4 is a diagram of a universal header attached to a sleeve according to an exemplary embodiment. FIG. 4 is a diagram of a universal header attached to a sleeve according to an exemplary embodiment. FIG. 4 is an illustration of an empty universal header and sleeve assembly attached to an injection pen with a visible locking indentation, according to an exemplary embodiment. 1 is an exploded view of a drug injection monitoring device according to an exemplary embodiment. FIG. FIG. 6 shows a sleeve attached to a Sanofi Aventis Lantus SoloStar injection pen according to an exemplary embodiment. FIG. 6 shows a universal header attached to a sleeve attached to a Sanofi Aventis Lantus SoloStar infusion pen according to an exemplary embodiment. FIG. 6 shows a sleeve attached to a Novo Nordisk FlexPen infusion pen according to an exemplary embodiment. FIG. 6 shows a universal header attached to a sleeve that is attached to a Novo Nordisk FlexPen infusion pen according to one exemplary embodiment. 3 is a flow diagram illustrating a method for monitoring infusion using a drug infusion monitoring device according to an exemplary embodiment. FIG. 3 illustrates a readable piston subsystem according to an exemplary embodiment. FIG. 1 illustrates a micro-optic and imaging system according to an exemplary embodiment.

  The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings illustrate the description according to an exemplary embodiment. These exemplary embodiments, also referred to herein as “examples,” are described in sufficient detail to enable those skilled in the art to practice the present subject matter. Embodiments may be combined and other embodiments may be formed by introducing structural, logical, or electrical changes without departing from the scope of the claims. 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.

  In this document, the term “one, one (“ a ”or“ an ”)” is used, as is well known in the patent literature, including one or more than one. This document uses the term “or (“ or ”)” to refer to non-exclusive “or” (or “or”), whereby “A or B” means “A” unless otherwise indicated. But not B "," B but not A "and" A and B ". In addition, all publications, patents, and patent documents referenced in this document are hereby incorporated by reference in their entirety as if individually incorporated by reference. Where there are conflicting uses between this document and those documents so incorporated by reference, use in the incorporated reference (s) is deemed to supplement the use of this document. Should be used, ie, inconsistent contradictions, the use in this document will dominate.

  In the exemplary embodiment described herein, the drug infusion monitoring device is a standard infusion pen accessory, which is small enough for a patient to carry in a pocket or handbag. This drug infusion monitoring device may allow the patient to leave an accurate infusion record. In addition to providing a way for a patient to leave a medication infusion record, the medication infusion monitoring device can provide cues and other warnings about events that can affect the patient's health.

  In some embodiments, the drug infusion monitoring device can record events and generate reports to find trends and patterns, thereby adjusting drug dosage, exercise or feeding. it can. Leaving this type of record can give patients with chronic medical conditions a long-term view of their illness, which allows them to control their illness and keep them healthy without complications from it. Help bring a healthy life.

  The drug infusion monitoring device according to an exemplary embodiment can be attached to various off-the-shelf infusion pens to record the time since the last infusion. This device can be activated automatically each time a user infuses a drug, thus providing a reliable means to write down the time elapsed since the last infusion. The ready-made injection pen may have various shapes depending on the manufacturer. To accommodate these various shapes, a method of attaching two parts can be used. The first part may be a sleeve that is designed to lock securely into a particular injection pen. The second part may be a universal header that is attached to the sleeve unit and houses the electronic circuit device.

  FIG. 1 is a perspective view of a drug injection monitoring device 100 according to an exemplary embodiment. As shown in FIG. 1, the medicine injection monitoring apparatus 100 includes a sleeve 120 and a universal header 130. The injection pen 110 is ready-made and is not part of the drug injection monitoring device 100. The infusion pen 110 may include a piston 112, which may be expanded to show the dose of the drug with a scale plate. The universal header 130 may include a display 132 for displaying various data related to drug infusion monitoring. For example, as shown in FIG. 1, the display 132 can display the time since the last infusion. Universal header 130 may also include one or more buttons 134 to allow the user to manipulate and display data related to medication infusion monitoring.

  In some embodiments, one or more buttons 134 can be used to turn on the display 132. In some embodiments, it is not necessary to utilize one or more buttons 134 to turn off the display 132, and the display 132 is automatically turned off after a period of time. In some embodiments, the display 132 does not display the time because the only time displayed is elapsed time. Furthermore, the start time and end time of the injection need not be displayed.

  As shown in FIG. 1, the sleeve 120 fits the injection pen 110 and the universal header 130 is locked to the sleeve 120 with a locking recess (not shown). This approach allows the universal header 130 to be attached to various existing injection pens. Thus, the drug infusion monitoring device 100 assists in attaching the two parts and the sleeve 120 is customized to fit a particular model of the infusion pen. As a result, the universal header 130 that houses the electronic circuit device can be used for various injection pens. In addition, this makes it easy to attach and detach the drug injection monitoring device 100 and allows its precise positioning for various injection pen types without complicated steps. In some embodiments, the drug infusion monitoring device 100 is fully automatic and does not require user input, thereby confirming operation and / or not recording events.

  The drug infusion monitoring device 100 can be characterized as a clip-on infusion recorder attached to the infusion 110 pen to help maintain optimal patient control. The drug injection monitoring device 100 is a clip-on type designed to fit a specific brand of injection pen. The header 130 shown in FIG. 1 can be strong enough for regular use and simple enough for infants and the elderly to attach and detach. The design of the medicine injection monitoring device 100 is thin and light and does not greatly increase the bulk of the injection pen 110.

  FIG. 2 shows a measurement history of the drug injection monitoring device 100 according to an example embodiment. As shown in FIG. 2, the drug infusion monitoring device 100 can record the dose and time (202, 204 and 206) of each infusion along with any warnings over a predetermined period. For example, for regular use, it can be read up to 4 times a day for 30 days. The user can set up to 4 injections and tolerances, which are “scheduled” times that the user will inject.

  FIG. 3 illustrates various messages that may appear on the display 132 of the drug infusion monitoring device 100 according to an example embodiment. As shown in FIG. 3, the display 132 allows the user to store recorded values and receive any warnings or messages directly from the medication infusion monitoring device 100. The drug infusion monitoring device 100 may be audible and visual after one or more of the following occur: an infusion error, an infusion dose outside the expected range, and a “double” infusion. An alarm can be issued. The medicine injection monitoring apparatus 100 can check and detect a certain situation to which a warning should be given. For example, the drug infusion monitoring device 100 can warn when the cartridge of the drug pen 110 is low or when the temperature of the pen exceeds the recommended safe range of the drug. This alarm is used to perform other scheduled events such as alerts, cues, or “injection due” reminders, or cues to change the needle after a certain number of injections or use. Can also be used.

  The alarm feature of the drug infusion monitoring device 100 can address all these points in a way that broadens the basic ideal of a simple alarm. In this regard, the device can learn from past usage patterns, can start predicting the optimal number of injections, and can suggest dosages. Thus, the device can monitor dangerous use, for example, more than recommended doses, or multiple doses in too short a time.

  This device automatically sends the use of the infusion to the “carer”, allowing remote confirmation and monitoring for those who care for the infant's parents and the elderly, It can also include a built-in SMS function that sends general summary information about usage or weekly usage, sends a real-time emergency SMS text message to report "dose" and inform potential risks .

  FIG. 4 is a perspective view of a piston crack or lock pin device of the pharmaceutical injection monitoring device 100 according to an exemplary embodiment. In some embodiments, if the drug infusion monitoring device 100 detects a “dangerous situation” (eg, a dose that is too high), the drug infusion monitoring device 100 may generate an audible alert and a visual alert. Not only can this device activate a locking pin as shown in FIG. 4 that prevents the user from pushing the piston 112. This pin may be spring loaded and the user must turn the dial to a lower dose before the user is allowed to release the pin and begin infusion.

  The drug injection monitoring device 100 can also include an interface for downloading data from a personal computer (PC) to the device and setting the device. As the user builds usage information over several weeks, this data is parsed by separate software on the PC to generate trend information. This information can be used to allow the user to “optimize” their drug usage, and this information can be “feedback” to the pen to suggest “doing” doses, Warning if there is a significant deviation from the dose. This information may be used by a physician to analyze any changes in the user's condition.

  The SMS functionality can allow third parties to be informed of any potentially dangerous situation regarding the level of drug, and in general, monitoring whether drug users are following their recommended routines It may be possible to allow. This can be important when caring for infants and the elderly. The SMS feature allows text messages sent to the infusion pen 110 to be displayed to the user on the display 132 when the downloaded usage data indicates that a routine change is required. It may be further expanded.

  In some embodiments, the user can receive recorded value records, alerts, and messages directly from the device using one or more buttons 134. The device may be able to alert audibly and visually after an infusion error, an infusion dose outside the expected range, and a “double” infusion. The device can also check and detect certain situations that should give a warning. For example, the device can warn when the cartridge is low or when the pen temperature exceeds the recommended safe range for the drug.

  In some embodiments, this alert may be an alert for cues or other scheduled events such as a `` signal to be infused '' signal or a signal to change the needle of the infusion pen after a certain number of infusions or use. Can also be used to conduct events. In addition, the device can learn from past usage patterns, can begin to predict the optimal number of infusions, and can suggest dosages. In addition, the device can monitor dangerous use, eg, more than recommended doses, or multiple doses in too short a time.

  In some embodiments, the device can help remotely monitor patient status by transmitting information wirelessly. For example, the device transmits information about infusion use to allow remote confirmation and remote monitoring for infant parents and caregivers of the elderly, with daily usage for a specified quantity or weekly usage. General summary information about usage can be sent, immediate emergency messages can be sent to report “double doses” and inform about potential risks.

  In some embodiments, the device may include an interface for downloading data for configuring the device. As the user builds usage information over a period of time, this data can be analyzed by separate software on the computing device to generate trend information. This information can be used to allow the user to optimize his or her drug use, and this information is fed back to the pen to suggest dosages and to warn if the user's use deviates significantly can do.

  FIG. 5 is a perspective view of the drug injection monitoring device 100 attached to the injection pen 110 according to an exemplary embodiment. As shown, the drug injection monitoring device 100 can include a sleeve 120 and a universal header 130. Universal header 130 may include a display 132 and one or more buttons 134. The universal header 130 can be attached to the sleeve 120 by sliding the universal header 130 over a rail of the sleeve 120 that is designed to accommodate the universal header 130. When the universal header 130 is so attached, the sleeve 120 squeezes the infusion pen 110 and holds the drug infusion monitoring device firmly in place.

  Thereafter, the drug infusion monitoring device 100 according to one exemplary embodiment can assist in controlling drug infusion by recording, monitoring, recommending, reporting, and protecting the user. The drug infusion monitoring device 100 can be small enough so that the patient can easily carry it anywhere as a standard infusion pen accessory. In addition to providing a quick and easy way to record a patient's medication infusion history, if those readings are provided to the universal header 130, the user can be signaled or warned so that medication Adjustments can be made during exercise or contact. This approach can give a person with chronic symptoms a long-term view of the patient's illness, which allows the patient to control the illness and lead to a healthier life without complicating the associated illness To help.

  The drug infusion monitoring device 100 according to an exemplary embodiment may not require user input because it does not need to confirm operation or record an event. Therefore, the medicine injection monitoring apparatus 100 can be fully automated. The medication infusion monitoring device 100 may include only one button, which is used to turn on the display 132. The drug infusion monitoring device 100 can record the dose and time of each infusion along with any warnings over a period of time. The drug injection monitoring device 100 can be set only for a plurality of injection times and an allowable range, which are the number of times that the user will inject.

  FIG. 6 is an illustration of the universal header 130 turned upside down according to an exemplary embodiment. FIG. 7 is a model specific sleeve for each infusion pen according to an exemplary embodiment. FIG. 8 is a universal header 130 attached to a specific sleeve according to an exemplary embodiment. FIG. 9 is a universal header 130 attached to a specific sleeve assembly according to an exemplary embodiment. The drug injection monitoring device 100 can be attached to various off-the-shelf injection pens to record the time since the last injection. This information helps a ready-made infusion pen user to maintain optimal diabetes control.

  The drug infusion monitoring device 100 is automatically activated each time a user infuses a drug, thus providing a simple and reliable means to write down the time elapsed since the last infusion. The ready-made injection pens may have various shapes depending on the manufacturer. To accommodate these various shapes, a method of attaching two parts is used. The first part may be a sleeve that is designed to lock securely into a particular injection pen. The second component is a universal header unit that is attached to the sleeve and that houses the electronic circuit device. FIG. 10 is an empty universal header and unique sleeve assembly that is attached to a particular injection pen model in which a locking indentation 136 is visible, according to an exemplary embodiment.

  FIG. 11 is an exploded view of the drug injection monitoring device 100 according to an example embodiment. As illustrated, the drug injection monitoring device 100 can include a cover plate 138, an electronic assembly 904, a sensor 902, a drug pen, a universal header 130, and a sleeve 120. In some embodiments, when the drug injection monitoring device 100 is attached to the injection pen 110, the drug injection monitoring device 100 places the sensor 902 on the edge of the piston (not shown) of the injection pen 110. In most injection pens, the user extends the piston to adjust the dose. When the piston is extended, the sensor 902 (eg, a microswitch) is switched to the open state. When sensor 902 is switched to the open state, the timer is reset to zero, indicating that an infusion has started.

  When the piston is pushed to complete the injection, the sensor 902 is closed and the timer starts counting. In some embodiments, a sound generating device (not shown) and / or a vibrating device (not shown) may be worn to alert the user. It will be appreciated that some injection pens may not use a piston to aid in injection. Thus, other techniques can be used to determine the occurrence and / or dosage of an infusion. For example, as described below with respect to FIG. 17, microoptics and an imaging system may be used to determine the occurrence and / or dosage of an injection.

  FIG. 12 illustrates a sleeve attached to a Sanofi Aventis Lantus SoloStar drug pen according to one exemplary embodiment. FIG. 13 shows a universal header attached to a sleeve that attaches to a Sanofi Aventis Lantus SoloStar drug pen according to one exemplary embodiment. FIG. 14 illustrates a sleeve attached to a Novo Nordisk Flexpen drug pen according to an exemplary embodiment. FIG. 15 shows a universal header attached to a sleeve that attaches to a Novo Nordisk FlexPen drug pen, according to an illustrative embodiment.

  FIG. 16 is a flow diagram illustrating a method 1600 for monitoring an infusion using a drug infusion monitoring device according to an example embodiment. The method can begin at operation 1602 when the piston 112 is in a lowered state. At decision block 1604, the method can determine whether the piston 112 is up. If the piston 112 is raised at operation 1602 to adjust the dose, the method 1600 can proceed to operation 1606 where the time display is reset to zero, thus counting the time since the last injection. Start. At operation 1608, relevant environmental data and usage data can be recorded. This relevant environmental data and usage data may include time, date, temperature, dosage, and other sensor data.

  At decision block 1610, it is determined whether an error notification needs to be issued based on a comparison of the recorded environmental and usage data with a predetermined optimal value. For example, if the time between injections is too short, an error may be communicated to the user. Accordingly, if it is determined at decision block 1610 that an error notification needs to be made, method 1600 proceeds to operation 1612 where an error is displayed by display 132. In some embodiments, other suitable alert actions may be taken. For example, if the time interval between two consecutive infusions is too short, vibration alerts and / or audible alerts may be activated.

  On the other hand, if it is determined in decision block 1610 that an error notification need not be made, no error is communicated. In any case, the method 1600 can proceed and at decision block 1614, it can be determined whether the piston 112 is depressed. If the piston 112 is not pushed, the method 1600 remains in idling mode waiting for the piston 112 to be pushed. Once the piston 112 is pushed, the method 1600 can proceed to operation 1618 where the display 132 can begin measuring the time since the last injection by indicating the elapsed time. In addition, a confirmation “beep” may be given.

  At operation 1620, the visual indicator can be set to reinforce this situation. For example, a portion of the device may indicate that it is dangerous to inject again during this period by “shining” red for a predetermined time interval after injection. Once the predetermined time interval has elapsed, the “shine” may turn green, indicating that it is safe to inject again. In addition, if another injection is expected, the elapsed time will go further, but if no other injection has occurred, the “shine” may turn yellow.

  FIG. 17 illustrates a readable piston subsystem according to an exemplary embodiment. As shown in FIG. 17, the secondary digitally readable piston subsystem may be physically attached to the piston head via a pen specific clip 1710 so that the secondary piston is connected to the piston 112 of the injection pen. Move in parallel. As the secondary piston slides in and out of the universal header 130, the electronics assembly inside the header 130 can read the linear position of the secondary piston and thus can infer the drug dose. . While the secondary piston is moving, the display 132 can show the estimated dose to the user for confirmation. The reading taken by the electronics assembly can also be used to time the infusion occurrence.

  FIG. 18 shows a micro-optic and imaging system according to an exemplary embodiment. As shown in FIG. 18, the micro-optics and imaging system may be incorporated into the universal header 130. A sleeve (not shown) can be designed to ensure that the universal header 130 is located on the physical dose scale plate of the injection pen 110. When activating a sensor (not shown) to indicate that an injection is about to start, the imaging system 1810 may be activated and image recognition may be performed by reading the maximum scale plate value. Is then stored in the memory of the drug injection monitoring device 100. During the imaging sequence, the raw data may also be displayed on the display 132, thereby allowing the user to read the actual dial value.

  The exemplary embodiment of the medicine injection monitoring device has been described above. Although embodiments have been described with respect to particular exemplary embodiments, various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the systems and methods described herein. It will be clear. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.

Claims (20)

A specific sleeve that is designed to lock firmly to a ready-made injection pen of a specific design;
A universal header designed to lock securely to the specific sleeve regardless of the specific model of the ready-made injection pen;
An electronic circuit device assembly housed by the universal header;
A sensor communicatively coupled to the electronic circuit equipment assembly for automatically detecting an injection;
A display for displaying infusion data;
A drug infusion monitoring device comprising one or more buttons for enabling manipulation and display of the infusion data, wherein the manipulation includes resetting time.   The apparatus of claim 1, wherein the infusion data includes an elapsed time since the infusion.   The apparatus of claim 1, wherein the detection of the injection is inferred from a push-in of the piston of the injection pen.   The apparatus of claim 1, wherein the universal header is locked to a unique sleeve with a locking recess.   The apparatus of claim 1, wherein the display is automatically turned off after a predetermined time to save power.   The electronic assembly includes one or more sensors for detecting environmental data and usage data, the environmental data and usage data including a time of injection, a temperature at the time of injection, and a dosage. The apparatus of claim 1.   The electronic assembly leaves a record associated with a predetermined infusion schedule, records the dose and the time of each infusion, and generates an alarm, the alarm is a signal for performing an infusion; Late infusion warning, early infusion warning, warning that the temperature of the infusion pen is not within the recommended range of drugs delivered by the infusion pen, warning that the infusion dose is outside the expected range, and The apparatus of claim 6, comprising one or more of cues for changing the needle of the injection pen.   The apparatus of claim 7, wherein the alert comprises one or more of a visual alert, an audible alert, a vibration alert, and an SMS message.   9. The apparatus of claim 8, wherein the visual alarm includes a display of one or more colors indicating the safety of the injection.   8. The electronic assembly according to claim 7, wherein the electronic assembly automatically performs one or more of report creation, measurement history editing, and past usage pattern learning based on the record. apparatus.   The apparatus of claim 1, wherein the one or more buttons are capable of receiving one or more of recorded values, alerts, and messages.   The apparatus of claim 1, wherein the electronic circuit assembly assists in remote monitoring of a patient's condition by communicating information wirelessly via one or more wireless protocols.   The apparatus of claim 1, further comprising a locking pin for preventing the injection by inhibiting the injection mechanism of the injection pen when it is determined that the injection produces an overdose condition according to predetermined criteria.   14. The device of claim 13, wherein the lock pin is released when a low dose is selected, or the lock pin is disabled by a button combination.   The apparatus of claim 1, further comprising an interface for transmitting data from the drug injection monitoring device and remotely configuring the drug injection monitoring device.   16. The apparatus of claim 15, wherein the data is analyzed using separate software to generate trend information, which allows trend and dose optimization.   The apparatus of claim 16, wherein the electronic circuit assembly is programmed according to the analysis. A specific sleeve that is designed to lock firmly to a ready-made injection pen of a specific design;
A universal header designed to lock securely to the specific sleeve regardless of the specific model of the ready-made injection pen;
A medication infusion monitoring device comprising: a dose reading system for reading the dose of medication delivered by the off-the-shelf infusion pen.   The dose reading system includes a pre-made injection pen-specific clip attached to a piston of the pre-made injection pen, and the dose is determined by the position of a clip shaft in the universal header. The device according to claim 18. A specific sleeve that is designed to lock firmly to a ready-made injection pen of a specific design;
A universal header designed to lock securely to the specific sleeve regardless of the specific model of the ready-made injection pen;
An electronic circuit device assembly housed by the universal header;
A sensor communicatively coupled to the electronic circuit equipment assembly for automatically detecting an injection;
A display for displaying infusion data;
A button for enabling manipulation and display of said infusion data, said manipulation comprising resetting time; and
An optical imaging subsystem communicatively coupled to the electronic circuit assembly for taking one or more images of a scale plate of the ready-made injection pen, wherein the particular sleeve comprises: An optical imaging subsystem designed to ensure that a scale reader is positioned over the dose scale, and activated when a micro-optical subsystem detects the injection by the sensor;
A drug injection monitor comprising: an imaging subsystem communicatively coupled to the electronic circuit assembly and recognizing features of the one or more images taken by the scale reader of the micro-optic subsystem apparatus.