• 专利附录
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    • 专利摘要:

    公开号:SE1550571A2
    申请号:SE1550571
    申请日:2013-11-20
    公开日:2016-06-14
    发明作者:Leif Halll；Truls Sjöstedt
    申请人:Brighter Ab Publ；
    IPC主号:
    专利说明:

    Method and device for logging injections of drugs that are madeof a medical device with injection meansThe present invention relates to an improved device for injecting a drug for use by diabetic patients, or other patients self-administering injectable drugs.
    BACKGROUNDDiabetic patients who inject insulin must check their blood glucose levels several times a day and perform insulin injections. They also need to record their blood glucose levels and the amount of insulin they inject in order to monitor the course of the disease. Today, several different devices are required to handle this: aids for testing blood glucose levels including aids for taking a blood sample (such as a lancet), disposable test strips and blood glucose meters, a device for injecting insulin and replacement needles and a logbook and pen for recording blood glucose values and injections. The diabetic patient must bring this equipment with him, which is not only cumbersome but also involves a risk for the patient as loss of the equipment creates a risk for the patient as malpractice can occur.
    Furthermore, since it is very important that the patient really treats himself, it is desirable that the self-administration causes minimal inconvenience to the patient, and affects the patient's life as little as possible.
    To solve this problem, devices have been developed which integrate all these functions, for example WO2009027950 which shows a portable medical device which integrates blood glucose measurement and insulin injection. It has a lancet to take a blood sample. The lancet and the injection means are located at the same end of an extended casing to prevent blood splashing on mechanical moving parts or electronic parts inside the casing. The site http://www.brightercompany.com/product-information as visited November 6, 2013 showed a film showing a medical device. It has a port for inserting a test strip next to and parallel to the injection needle. The device has a display that shows both blood glucose values and the amount of insulin that will be injected by the device.
    Diabetic patients are accustomed to performing the various steps including blood glucose measurement and insulin injection in a certain order and in a certain way. This helps the patient perform the procedure safely. There is therefore a need for a safe and integrated device.
    There is also a need for improved logging of injections. At present, blood glucose measurements are usually recorded manually by the patient. Manual registration often causes handling errors, so e.g. the patient forgets to enter a value, or enter the wrong value. Automatic logs have been suggested, e.g. and WO2012068214.
    Before each injection, it is important that the user "primary" the injection needle, to ensure that there are no air bubbles or stops in the needle. This is done by injecting a small amount of drug from the needle. A disadvantage of current automatic logs is that they cannot distinguish between real injections and priming injections. WO2009083600 proposes a medical device that can log insulin injections and distinguish between actual injections and primer injections based on the velocity of the fluid during expulsion. However, this presupposes that the expulsion speed is controlled by the device. In devices where the injection speed varies, for example by the user using a plunger having different speeds from time to time, such a solution cannot be used.
    There is therefore a need for improved logging that can differentiate between real injections and priming injections in a safe and easy way.
    SUMMARY OF THE INVENTIONIn one aspect of the invention there is provided a method of logging insulin injections performed by a medical device with injection means comprising the steps of determining the amount of insulin expelled from the medical device, storing the time of expulsion together with time data as an expulsion event, determining, with a proximity sensor in the device, where said proximity sensor can detect the proximity of a solid object in the direction of the injection needle, if expulsion of the medical device takes place in the vicinity of a solid object, mark the injection as an injection event if expulsion occurs near a solid object and as a priming injection if expulsion does not occur in the vicinity of a solid object.
    The method can be used to log events in an electronic logbook that can be easily accessed by the user through a user interface on the device. The electronic logbook is an improvement on current logbooks that cannot distinguish between real injections and priming injections. The user thus receives a reliable log for injections and glucose measurements, which improves safety.
    It is preferred that expulsions be marked as an actual injection if the distance, when injecting, from the front wall 4 of the container housing to an object is less than a threshold value T, which may be 200 mm.
    In an alternative embodiment, the injection is saved as an actual injection if, when insulin is injected, the distance from the sensor to the needle tip (D1) is greater than the distance from the sensor to the object (D2) and where D1-D2> 0.1 mm.
    In one embodiment, the method is such that injection events are available to the user through a user interface on the injection device and priming expulsions are not available to the user through a user interface on the injection device. The priming events are only available through, for example, a data port, or after a code is entered. In this way, the priming events are not visible to the user. This has the advantage that the user does not confuse the priming events with actual injections in the log. However, the priming events are still available to physicians, nurses, and service personnel.
    The user can use an interface to label real injections with additional information with a selected from the group of a blood glucose measurement, health status, meal intake and exercise. In particular, the method may include the additional step of automatically labeling an actual injection with a blood glucose measurement if the blood glucose measurement is made within 30 minutes of the injection. The advantage of this is that blood glucose values are affected by insulin injections, meals, exercise and illness. It is thus important that the user, when going through his blood glucose measurements, can take into account meals etc. in a simple way. The advantage of automatic marking is that marking takes place even if the user forgets to mark.
    In a second aspect of the invention there is provided a medical device invention which is suitable for carrying out the method according to the invention. Thus, a portable medical device for injecting insulin is provided comprising means for injecting insulin into a patient, means for automatically saving the amount of insulin injected at a given time as an injection event and a proximity tendon which can sense the proximity of a solid object in the same direction. as the injection needle where the medical device is configured to label an injection event as an injection if injection occurs in the vicinity of a solid object and label the expulsion as a priming injection if ejection does not occur in the vicinity of an object. The sensor may suitably be an infrared sensor. The device may be arranged to label expulsion as injections when the distance from the front wall of the container housing to an object is less than a threshold value T which is described in more detail below. The threshold value can be 200 mm. In an alternative embodiment, the device suitable for performing the method is configured to label expulsions as injections if the distance from the sensor to the needle tip (D1) is greater than the distance from the sensor to the object (D2) when insulin is injected and where D1-D2> 0.01 mm.
    DEFINITIONSAs used herein, "user" and "patient" refer to the person using the device to test blood glucose and inject himself with insulin.Although insulin is often referred to in the application, the invention can be used for devices for injecting other drugs that the patient gives himself, such as growth hormone.
    "Insulin" refers not only to insulin in its natural form but also to variants and analogues given to diabetic patients.
    "Tagging" means storing additional information about a database record in a database.
    BRIEF DESCRIPTION OF THE FIGURESFIG. 1 is a schematic view of the medical device.
    FIG. 2-3 are schematic overview views of an injection needle and an insulin container.
    FIG. 4-5 show examples of the outside of the device.
    FIG. 6 shows examples of how sensors can be arranged.
    FIG. 7-9 are examples of how the second display can be arranged.
    FIG. 10 is a schematic overview of a sensor connection to a process unit.
    FIG. 11-13 show examples of how the first and the second display and second features of the device can be arranged.
    FIG. 14 shows the threshold distance of a distance sensor of the device.
    FIG. 15 is a flow chart showing a method of logging insulin injections.
    FIG. 16 is a schematic overview of an example of a database.
    FIG. 17 shows various connections to a process unit.
    FIG. 18-19 are flow charts showing examples of how blood glucose measurements and injection events are logged. FIG. 20-22 shows how a proximity sensor can be used to classify expulsion events.
    DESCRIPTION OF EXAMPLES OF EMBODIMENTSFIG. 1 is a general overview of the medical device 1, which in a preferred embodiment comprises injection means comprising a container housing 10. The container 40 is placed by the user in the container housing 10 of the device 1. Injection of insulin is performed with a needle 42 whose needle base 44 is connected to the top the container 40 by the user shown in FIG. 2 and 3. The container 40 and the needle 42 are usually provided separately from the device and are not included in this invention. Returning to FIG. 1, wherein the injection means further comprises a drive mechanism 13 which provides for expulsion of insulin through the needle 42 and means for adjusting the amount of insulin to be injected (dose setting means).
    The drive mechanism 13 may include a piston 41 which provides for expulsion of drug through the needle 42. The front of the main portion of the container 40 may rest against the front wall 4 of the container housing 10 as shown in FIG. 14 (note that the needle points in opposite directions in FIG. 1 and FIG. 14).
    The device suitably comprises a blood glucose meter 9. The device 1 is suitably portable. The user can then easily take the device with them.
    A preferred design of the device 1 comprises a housing 7 which is a hollow body containing the various parts of the device. The housing 7 suitably has a size and shape that allows the user to hold it in his hand. The cover may have one or more removable parts which serve as cover caps 8, such as the cover cap for the injection needle. The cover can be made of plastic or metal, where plastic is preferred. The drive mechanism 13 is included in the housing 7, as well as the process unit and the glucose meter.
    Typically, the device 1 is used in the following manner. First, the user uses the lancet 22 to puncture the skin to obtain a drop of blood. The drop is then brought into contact with the end of a test strip. The other end of the test strip has been inserted into the blood glucose meter through port 2. Based on this value, the user sets the amount of insulin to be injected. The user then adjusts the amount of insulin and injects himself.
    The device 1 has an interface with at least one display. The display can show different types of information, such as blood glucose measurements, injection events, date and time. It is often desirable that the injection means, including the display showing the amount of insulin to be injected, be user operated i.e. operated by the user. Such injection means have proven to be very reliable because they do not require electricity and the drive mechanisms are very durable. Examples of user-driven drive mechanisms for injecting insulin include mechanisms driven by the user by depressing an injection trigger. Examples of user-driven mechanisms are known in the field. Examples include US 5,593,390, US 6,221,046 and WO2009027950. A user-driven device may suitably have a mechanical display. These do not need any electricity and are very reliable.
    However, it is convenient that the device 1 has a display which is small, light and which can display a variety of symbols and characters which can be easily connected to a microprocessor. Therefore, in a preferred embodiment, the device 1 has two displays: a first display 3 which is non-mechanical, preferably an electronic display such as e.g. an OLED, PDP or LCD display, and a second display 6 which is mechanical and which shows the dose setting. FIG. 4 shows an example of the outside of the device 1. The first display 3 is mounted in the housing 7. The second display 6 and the dose setting means 5 are also visible. A part of the housing 7 forms a removable cover cover 8 which protects the injection needle. When the cover 8 is attached, the needle 42 is inside the housing 7. FIG. 5 shows substantially the same thing as FIG. 5, as it shows the housing 7 of the device 1 with the cover 8 removed to show the container housing 10, the needle 42 (with additional protective cover). First display 3, second display 6 and dose setting means 5 are also visible.
    The medical device 1 will now be described in more detail with reference to FIG. Preferably, the device 1 is equipped with a blood glucose meter 9 as shown inFIG. 1. Blood glucose meters are well known in the field. Blood glucose is usually measured with a disposable test strip known in the field. The test strip can be of a type that contains one or more chemicals that react with glucose in the blood in a way that allows the blood glucose level to be measured. The test strip can e.g. be of standardglucose oxidase / ferrocyanide type where the glucose concentration affects the electric current in a way that can be translated into a blood glucose concentration.
    Blood glucose measurement of the meter 9 is suitably started automatically when a test strip is inserted into the port 2. For example, a sensor can detect when a test strip is inserted into the port 2. An example of how the test strip is inserted into the port is shown in FIG. 13. The user then touches a drop of blood against the edge of the test strip which absorbs the blood and moves it with capillary force along the stick to the site where the chemical reaction takes place. Typically, a blood drop with a volume of 1-20 microliters is used.
    With the help of the blood glucose meter 9, the glucose concentration can be determined and shown on the first display 3 within a few seconds, which allows the user to go into injection mode and set the amount of insulin to be injected. Blood glucose readings are usually expressed as mmol / L or mg / L and the device may suitably display the blood glucose concentration in any of these units.
    The means for injecting insulin comprises a container housing 10 for inserting a container 40 which is filled with insulin. The container housing 10 has at least one front wall 4 which restricts the movement of the insulin container 40 in the direction of injection. The needle 42 in FIG. 2 and FIG. 3 can be snapped or screwed onto the top of the container 40, or connected to the container 40 with a luer-type lock. The container 40 can be easily replaced by the user.
    The injection means comprises a drive mechanism 13 which causes the piston 41 to move when the user presses the trigger 12. The drive mechanism 13 can be performed in various ways as long as it is suitable for injecting insulin from an insulin container 10 into a patient and can be combined with sensors on the manner described below.
    Injections and sensors described below. The means for injecting insulin comprises means 5 for adjusting the amount of insulin to be injected (dose setting means). The dose setting means may be a rotatable knob 5, but may also be any means by which the user may instruct the device 1 to change the dose setting. It can be, for example, plus / minus buttons or a lever. The rotatable button suitably has grooves that improve grip. The amount of insulin to be injected is shown on a display 6, called a second display 6, which is described in more detail below. Typically, the setting values for the second display are 6: 0,1.0,1.5, 2.0, 2.5 and so on where the numbers represent insulin units, where one unit is 0.01 ml of drug.
    The means for injecting insulin also includes an injection trigger 12. This may be in the form of a button which can be pressed by the user. The dose button and the injection trigger can be integrated in such a way that the rotatable button 5,12 can be pressed down and that injection takes place when it is pressed down.
    The drive mechanism 13 may be an electric pump. However, it is preferred that it be a user-driven mechanism. Examples of mechanical drive mechanisms are, for example, US 5,593,390, US 6,221,046 and WO2009027950.
    The drive mechanism 13 can be driven by the user in such a way that when the user uses the injection trigger 12, the power is transmitted to the drive mechanism 13. The amount of insulin to be injected is adjusted by turning the dose setting means 5 so that the mechanism 13 can move the plunger 41 so that insulin is expelled from the container And that the dose setting means determines how far the piston should move.
    The drive mechanism 13 can be combined with an inactivating means which suitably comprises at least one sensor which can sense movement or setting of the drive mechanism 13. In general, sensors which can sense movement or setting of a mechanism are well known. The sensor may be a position sensor which senses the position of a part of the drive mechanism 13. The at least one sensor may be connected to and arranged to communicate with process unit 19.
    The device suitably has an inactivating means which comprises a sensor 17 which can sense when the dose setting means is set so that injection of insulin is allowed as described below.
    Preferably, the device has a sensor 33 that can sense the amount of insulin that has been expelled from the device. The sensor 33 is connected to the drive mechanism 13 in such a way that it can send a signal which is related or proportional to the amount of insulin which has been driven out of the device. An example of how such a sensor can be arranged is shown in Fig. 6 which shows a sensor which senses rotation of a part of the drive mechanism 13. Rotating part 27 is part of the drive mechanism 13 and has an edge which forms a gear 32 to which gear 31 is connected. Rotation of gears 31 is detected by a magnet sensor 33 which sends a signal to the process unit 19. When the user presses the injection trigger 12, the rotating member 27 rotates during injection of insulin causing rotation of gears 32 and 31. Rotation of gear 31 and signal from magnet sensor 33 is proportional to the rotation of the rotating part 27 and thus to the amount of insulin that has been expelled.
    The device 1 has a user interface which comprises one or more displays, buttons for navigating menus, a display and an input device for making inputs. The user can obtain information such as the status of the device, blood glucose values, and the setting of the dose setting from at least one display. Some embodiments of the device 1 have a single display. In this application, "first display" shall refer to this display.
    In a preferred embodiment the device has two or more displays: a first display 3 and a second display 6.1 this embodiment the purpose of the second display 6 is mainly to show the setting of the dose setting means, and thus to show the amount of insulin to be injected (or to express oneself). clearer: to be injected by the device). In a preferred embodiment, the second display 6 shows only the setting of the dose setting means. Other information such as blood glucose values is shown on the first display 3.1 in particular blood glucose values are shown on the first display. In one embodiment, the device has a mechanical display (second display 6) that can show the amount of insulin to be injected by the device and at least one electronic display (first display 6) that can show blood glucose values.
    The first display 3 can be either on or off. In this application, "turned on" means that the first display 3 can show letters and numbers, for example blood glucose values, and "turned off" means that the first display 3 does not show any letter, number or symbol that can be confused with a letter or number. For example, the first display 3 may show lines or circles or other figures that can only with low probability be confused with an actual dose setting or an actual blood glucose value, and still be considered rejected. This indicates to the user that the first display 3 is not broken but that it does not currently show any information. For example, if most of the display shows several lines with dashes (so-called dashes), it should be considered off. As another example can be mentioned if the first display shows several lines containing several lines of the same number, e.g. the number "8", it should also be considered as rejected, as this can probably not be mistaken for a real glucose value or injection.
    FIG. 7-9 show a way in which the second display 6 can be arranged when it is a mechanical display. Here, the second display 6 is arranged on the short side of the device 1. The sleeve 14 which is part of the drive mechanism 13 rotates with the dose setting means 5, and the sleeve 14 has dose markings on the outside. The sleeve 14 is arranged in the housing 7 so that a part of the sleeve 14 is visible through a window 15 in the housing 7 as shown in FIG. 7-9. FIG. 8 shows the display seen from above and FIG. 9 is an enlargement of FIG. 8. The sleeve 14 is connected to the dose knob 5 so that the sleeve 14 rotates when the dose setting knob 5 is rotated. The selected dose is displayed in the window 15 and is indicated by an arrow or a line 16 on the housing 7. Rotation of the sleeve 14 determines the amount of insulin to be injected by the drive mechanism 13. The second display 6 can also be such that all the numbers are visible and that the selected the value is indicated by a line or an arrow.
    In a preferred embodiment, the first display 3 is automatically switched off, by an inactivating means, for example a position sensor, when the dose setting means 5 is set so that injection of insulin is allowed. Thus, the first display 3 is turned off when the dose setting means 5 is set to - for example - 1,0,1,5, 4,5 and so on, but is inactive when the setting is 0 (zero) or any other setting that results in insulin can not be injected. For example, in addition to setting 0 (zero), there may also be an "off" mode which also deactivates the injection means, which allows activation of the first display 3.
    This arrangement directs the user's attention to the second display showing the amount of insulin to be injected. This reduces the risk of the user setting the wrong value. For example, there is no risk of the user looking at the blood glucose value and believing that the measured value for blood glucose is the dose to be injected. Furthermore, the user is instructed to take the next step in the procedure and complete that step and not go back to the previous step (which was the blood glucose measurement). In this way, the user is guided towards taking the next step in the procedure.
    A schematic overview of an example of an inactivating means of the device is shown inFIG. When the dose knob is rotated, a sensor 17 which may include a switch 18 sends a signal to the process unit 19 which turns off the first display 3. The sensor 17 may for example comprise a spring which causes a device to press against a rotating part of the dose setting means, where said device can move a switch 18 when the device goes down into the gap in the rotating part of the dose setting means. The position of the gap is such that the device can enter the gap only when the dose setting button 5 is set to zero.
    Another example of such a sensor 17 is shown in FIG. The switch 18 is arranged to sense a downward and rotating movement of the sleeve 14 which sets the amount of insulin to be injected. When the sleeve 14 is in its lowest position, the drive mechanism 13 is set to zero and the part 29 of the sleeve 14 is in contact with the switch 18. When the user turns the setting knob 5 to set the amount of insulin to be injected, the sleeve 14 rotates and moves upwards in FIG. 6 so that the part 29 releases the switch 18 which sends a signal to the process unit 19.
    The inactivating means can be arranged in many other ways. For example, a semiconductor-type accelerometer of the type used in mobile phones (smartphones) can be used to sense movement or position of a part of the drive mechanism 13.
    The dose setting means of the user-driven mechanisms of US 5,593,390, US 6,221,046 and WO2009027950 can be easily adapted by a person skilled in the art so that they can be sensed by sensor 17 and sensor 33. Thus, e.g. US 5,593,390 injection means with cam members which can act on a counter which can act as a sensor 17.
    The device can be such that the first display 3 is reactivated automatically when the dose setting means is set to zero. This is a practical way for the user to reactivate the display if necessary, if e.g. the user has forgotten the blood glucose value and has to double check it.
    At the same time, it forces the user to set the value to zero if he or she needs to turn on the first display. This can be achieved by sensor 17 sensing that the dose setting means 5 is set in a position which does not allow injection of insulin. When the user, as described above, sets the dose setting means 5 to zero, the sleeve 14 is in its lowest position in FIG. 6. When the sleeve 14 is in this position, the part 29 is in contact with the switch 18 which sends a signal to the process unit 19 which allows the first display 3 to be switched on.
    In one embodiment, the display automatically turns on when the injection of insulin has been completed. This can be achieved by the sensor 17 sensing that the dose setting means has returned to zero during expulsion. Referring to FIG. 6, the sleeve 14 moves downwards during expulsion of the drug so that the part 29 reaches the switch 18 when the trigger 12 is pressed down so that zero is reached. Thus, the first display 3 is switched on again. This allows the user to notice the injection event as described below, if he or she wishes to do so. Again, the user's attention is drawn to the next step in the process which is to use the first display 3 to log the injection event.
    In one embodiment, the first display 3 and the second display 6 are not visible to the user at the same time, so that the user cannot read the first display at the same time as the second display. An advantage of this arrangement is that the user cannot mix the values on the two displays. The two displays can, for example, be arranged geometrically in such a way that it is only possible to see one display at a time. Alternatively, the display can be of a type where the numbers are only visible from a certain angle.
    The displays are preferred on different surfaces of the device in the manner shown in FIG. 11-12 where the first display 3 is on a first side 20 of the housing 7 and the second display 6 is on a second side 21 of the housing. The relationship between the surfaces of the displays 3.6 can be defined by the angles between the surfaces of the displays. FIG. 12 shows an example of an elongate device 1 seen from the dose setting means 5. The angle α between a line which is perpendicular and directed towards the surface of the first display 3 and a line which is perpendicular and directed towards the surface of the second display 6 is at least 45 °, more preferably 60 °, more preferably at least 70 °, more preferably at least 80 ° and most preferably at least 90 °. Line that is perpendicular to the surface of the display refers to a line that passes through the surface of the display on the part of the display where the displayed number is visible. Typically, this will be the direction from which the user most easily looks at the display. When the angle α is 45 ° or more, it is difficult for the user to see both displays at the same time, which reduces the risk of confusion of the two displays and further directs the attention of the user / patient.
    The device may be equipped with a lancet mechanism for connecting a replaceable lancet 22 as schematically shown in FIG. 1 and FIG. 13. The lancet is typically a sharp needle made of surgical steel that can make a small hole in the skin so that a drop of blood can be obtained, which can be used for glucose measurement. Typically, the lancet is driven by a spring mechanism and is ejected after interaction by the user, for example when the user presses a trigger.
    It is preferred that the lancet and its mechanism be enclosed in the housing 7 when not in use, and that the tip of the lancet 22 be pushed out through a small opening in the housing 7 when the user presses the trigger. The lancet should be pushed out at a speed sufficient for the lancet to puncture the skin and preferably have a stroke depth of 2-3 mm. Lancet mechanisms are well known in the art. An example of a lancet mechanism is shown in WO2009027950. The lancet can also be powered by gas pressure. An advantage of the device also including a lancet is that the user has fewer loose things to keep track of.
    The housing of the device may be elongate and have approximately the proportions shown in FIG. 13,FIG. 4 and FIG. 5. Again, it should be pointed out that the size of the casing is such that it can rest in the user's hand in a simple manner. When the housing is extended, the lancet or location for connecting the lancet 22 is suitably located at one end 23 of the housing 7 and the container housing 10 is preferably located at the opposite end of the extended housing 24. Furthermore, the injection trigger 12 is preferably located at the same end 23 of the housing 7 as the location for connecting the lancet 22. This has the advantage that when the user is in a position to interact with the injection trigger 12, for example by having a finger positioned to press the injection trigger 12, he will not try to inject himself. with the lancet 22.
    When the housing 7 is extended, the first display 3 is suitably located in the middle of the extended shape as shown in FIG. 13. When the device comprises a glucose meter, the port 2 of the test strip is also preferably located in the middle of the extended shape as shown in FIG. 13. In this way, both interaction sites for glucose measurement are located in the middle of the housing 7 of the device 1. The center of the surface of the first display 3 is thus located about 50% from the end of the housing 7. About 50% comprises 30% to 70%, more preferably 35% to 65% and most preferably 40% to 60% of the distance from the end of the housing. Furthermore, the second display is preferably located at one end of the housing, preferably the same end 23 as the lancet 22. This further separates the first and second displays and mentally connects each display to a particular way of interacting with the device, making this easier to access. remember. It also has the advantage that the first display 3 is clearly visible when the device is held with two hands.
    The medical device 1 can be equipped with a proximity sensor 35 connected to a process unit 19.
    This can preferably be done without contact with the object. The proximity sensor must be able to sense the user's body if the skin is bare or covered with clothing. It should also be able to feel skin of different colors.
    The proximity sensor 35 may be a sensor which measures distance and which sends a signal to the process unit 19 which can be translated into a distance measure. Alternatively, the sensor may be a binary proximity sensor which does not measure the distance but which creates a detectable signal if a solid object is within a threshold distance.
    The proximity sensor 35 is suitably arranged to transmit a change in a signal when an object is within a threshold distance. The sensor can thus be arranged to send a signal when an object is within a threshold distance and to stop transmitting the signal when there is no longer an object within the threshold distance. The sensor can also be arranged to continuously send a signal if there is no object within the threshold distance, but to stop transmitting the signal if it is an object within the threshold distance. The threshold distance T is defined in the manner shown in FIG. 14.
    The proximity sensor 35 suitably reacts to an object of a certain thickness so that it does not sense a finger or a small object passing through the detection zone, but so that it reacts to a larger object such as a bone or the user's stomach. The proximity sensor 35 should be such that it senses the distance from the medical device to the body or part of the body of a patient that is suitable for receiving an insulin injection.
    The sensor can be based on heat, IR (infrared light) or radio, where IR is preferred. The sensor can be based on amplitude, frequency, phase shift or shading of an object. The desired signal can be produced by a change in, e.g. capacitance, alternatively the sensor may comprise a transmitter and a receiver. Preferably, the IR sensor has a transmitter that emits IR and a receiver that receives IR reflected by a solid object. LED technology is suitably used to transmit the IR wave. Examples of proximity sensors are US 8536507 B2 and US 8350216 B2.
    The sensor can be used to automatically distinguish priming injections from real injections in the manner shown in FIG. 15 and 20-22. This is because the user "primary" injections properly, i.e. that he does not primary injections by injecting into an object. When the device 1, by means of the proximity sensor 35, senses a solid object 50 within a certain distance T, it is assumed that the expulsion event is a correct injection and when there is no solid object 50 within a certain distance T, it is assumed that the expulsion is a priming injection.
    FIG. 20 is a schematic view showing the device 1 with the needle 42 pointing in the direction of a solid object. The proximity sensor 35 with sensing zone 51 is also shown. In this figure, the solid object 50 is not within the threshold distance T and the expulsion is logged as a priming injection.
    FIG. 21, on the other hand, shows substantially the same thing as FIG. 22 but here there is a solid object, the patient's body, within the threshold distance T and the expulsion is logged as a real injection. The detection zone is not shown in FIG. 21 for clarity.
    The proximity sensor 35 can suitably transmit and receive through an opening in the housing 7. The proximity sensor 35 is suitably placed as close to the tip of the needle as is practically possible, and directed towards the tip of the needle. Sensing of the sensor 35 is done in an approximate direction towards the tip of the needle 42, so that it can sense when an object is in front of the tip of the needle.
    The signal from the proximity sensor 35 can be used to distinguish between injection events and priming expulsions in the manner described below. The signal is suitably received by the process unit 19 which uses the signal to distinguish between priming expulsions and injection events.
    The device comprises a process unit 19 which controls the device. The processing unit receives data from the glucose meter 9, the sensor 17 (which includes the switch 18) for the dose setting means, the expulsion sensor 33 and the proximity sensor 35. The processing unit 19 also receives input from the user and controls the first display 3. It can store information in a database 200 which can be shown on the first display 3 in the form of an electronic logbook. The process unit 19 can be an integrated circuit, which using today's technology can have a nanometer-scale architecture, similar to that used in today's mobile phones. The process unit therefore does not take up much space in the housing 7. There is also a memory 38 which allows the user to save data, for example by logging injections and blood glucose measurements, preferably in the form of a database 200. The process unit 19 can also be connected to a computer by a data port 36, for transmitting data and for updating software stored on the device. Such a connection can be, for example, a USB or a micro-USB connection. The data port 36 may also be a wireless connection such as a Bluetooth or a Wi-Fi connection.
    Various different connections to the process unit 19 are shown in FIG. The processing unit may have an interface for a switch 18 of sensor 17 which senses when the dose setting means is set to allow injection of insulin.
    The processing unit 19 may also have an interface for sensor 33 which senses insulin injections performed by the insulin injection means.
    The process unit 19 is driven by an energy source such as a battery 34. The battery 34 also drives other components of the device which require electricity such as the first display 3 and the integrated glucose meter 9. The battery 34 can be conveniently accessed and replaced by a hatch in the housing. The connection for charging can be a USB data port. The data port 36 can also be used to retrieve data stored in the memory of the process unit 19.
    The process unit 19 is also connected to the first display 3 and to the integrated blood glucose meter 9 and to the proximity sensor 35.
    The process unit 19 further has a device 36 for manual input of data e.g. buttons, a mini-joystick, navigation pad or similar device with which data can be entered and with which one can navigate and scroll in menus. A clock 37 provides time and date information and can also act as a timer for the process unit 19.
    The process unit 19 comprises a memory 38, such as e.g. a flash memory, for storing software and data created by the device 1 and by the user, such as a database 200. The memory does not necessarily have to be included in the device but can also be accessed through a wireless network.
    The database can be used to log blood glucose measurements and insulin injections in a logbook so that users can retrieve them.
    In a preferred embodiment, the device has an integrated electronic logbook that can log blood glucose measurements and insulin injections. The electronic log is essentially a database 200 stored in a memory 38 of the process unit 19 where the database 200 can be easily accessed through the user interface, preferably the device's first display 3. Glucose measurement events and expulsion events are stored as records in the database 200. A schematic overview of the database 200 shown in FIG. 16.
    For example, the user can access the electronic logbook by selecting commands in the menu by scrolling through the display using +/- buttons and then see a list of blood glucose measurements or injection events, or both. Conveniently, the events can be displayed in chronological order with the most recent event first. Injection events and glucose events can be labeled with additional information, i.e. additional information regarding these events can be stored in the database.
    FIG. 15, 18 and 19 are flow charts showing examples of how the process unit 19 and the sensor 35 operate when the user performs processing and logs events according to the method of logging of the invention. The steps in FIG. 15, 18 and 19 are controlled by software stored in the memory and performed by the process unit in a conventional manner. Any suitable programming language or programming technology can be used to implement the database and the electronic log.
    In its most general form, the method of logging drug injection is an implementation of the method schematically shown in FIG. The electronic log comprises a database 200 stored in the memory of the process unit 19 38.1 step 600, an injection event is stored in the memory of the device, the injection event containing information on the amount of drug expelled and the time and date thereof. During or immediately after expulsion, the proximity sensor 35 detects if there is any solid object 50 in the vicinity of the direction of the injection needle. If there is no solid object nearby, e.g. if a threshold value for distance to a solid object is exceeded, a decision is made in 601 to label the expulsion event as a priming event in 602. If there is a solid object nearby, the event is labeled as an injection in step 603.
    The method is preferably performed automatically by the device. Decision step 601 can be performed in various ways. In case the proximity sensor 35 transmits a signal that can be translated to a distance measure, the signal can be processed by the process unit 19 which has stored the threshold value and compares the signal with the threshold value and makes the decision in 601. In the case of a binary proximity sensor, the sensor 35 can decide if there is a fixed object within the threshold distance and sends a signal about this to the process unit 19.
    In a preferred embodiment, the threshold distance T can be set relative to a position fixed relative to the injection needle, preferably the front wall 4 of the container housing 10 is measured from the inner surface of the front wall 4 to where a solid object causes a change in a signal which causes an expulsion event to be classified as a priming injection or an injection as shown in FIG. 14.
    The user has normally been instructed to prime injections by holding the injection means vertically with the needle pointing upwards and then injecting a small amount of drug while the user observes that drug is expelled from the needle in a normal manner, i.e. so that no air is left in the needle and so that there is no blockage in the needle. In normal use, it is thus unlikely that priming is done with the needle near a solid object.
    T is suitably selected so that it includes most lengths of needles (including the needle base) but at the same time short enough so that incorrect logging does not occur, if the user, for example, holds the device under a lamp when priming takes place. Needles for injecting insulin are usually between 4 mm and 13 mm long. Thus, if injection occurs when there is no solid object within 200 mm, 100 mm, 50 mm, 40 mm, 30 mm, 25 mm, 20 mm, 18 mm, or 15 mm from the front wall 4, the expulsion event is most likely is a priming injection. These distances allow most containers, lengths of injection needles and different types of needle bases.
    The sensor measurement can be performed relatively quickly (under 1 second) and can be performed at any time during expulsion, or immediately after expulsion. Alternatively, measurement is performed several times during expulsion.
    In the following, with reference to FIG. 18 and 19 how the user can use the electronic logbook to log glucose measurements and drug injection events. A user starts a test by inserting a test strip into the port of test strip 2. This can be detected by the integrated blood glucose meter 9, which is then switched on automatically. Alternatively, the user turns on the device manually by using the manual input device 36. The process unit 19 can then execute a system checking program to check that the device is operating normally, and for example check that there is enough battery power to perform the subsequent steps. . The first display 3 is then suitably switched on, which shows the user that the device is prepared for a blood glucose test. At this stage, the display suitably shows text instructing the user to enter a blood sample, such as e.g. "WAITING FOR BLOOD TEST". The user then takes a blood sample, preferably using lancet 22, and places a drop of blood on the test strip. If this is not done within a suitable time frame, such as e.g. 5 minutes, the program in the process unit 19 can possibly switch off the device so that the battery is saved. The integrated blood glucose meter 9 automatically detects when a blood sample is inserted and then measures the level of glucose in the blood. Since it takes some time to do this, the microprocessor can conveniently inform the user on the first display 3 that measurement is in progress, e.g. by displaying a timer that counts down or by displaying the text "ANALYZING". 5 seconds is usually enough to analyze the blood sample. The device can then display an instruction to the user to remove the test strip from the test strip port 9. The blood glucose measurement is stored in step 400 as a blood glucose measurement event in the database 200 in the process unit memory 38 together with the date and time of the assay. The blood glucose value is then shown on the first display 3 in step 401. However, step 401 can be performed at the same time as, or before, step 400. The user can now, in step 402, be given the opportunity, in step 403, to store additional information together with the blood glucose measurement in the database. 200. This may include adding data indicating any of the following: if the user has recently eaten, if the user has recently exercised, or if the user is unwell. This procedure is called "tagging" the blood glucose measurement event. For example, by scrolling through a menu, the user can first select "mark" and then select one of "MEAL", "MOTION" or "NAUGHTY". If the user, in step 402, chooses not to add a label, then the device can be switched off automatically in step 404 after a certain period of inactivity, e.g. 10 seconds. The blood glucose measurement events and the injection events in the database 200 can be accessed at any time by the user. This can be done by e.g. start the device and select "LOGBOOK" in the menu. The user can then read the various blood glucose measurement events in a list by scrolling through the menu. The database 200 can also be conveniently accessed through the data port 36, so that the contents of the database 200 can be transferred to a PC, tablet or other type of computer.
    Injection events can be stored in the database 200 in the following manner. In step 500, the process unit detects an insulin injection and determines the amount of insulin that has been expelled. This can be achieved by the sensor 33 sending a signal to the process unit 19.
    When the injection means has a sensor 17, the process unit 19 may use a signal from sensor 17 to be prepared to receive input from sensor 33 as follows. When sensor 17 sends a signal to the process unit 19 that the dose setting means is set to allow injection of insulin, the process unit is put in a state so that it is ready to receive a signal from sensor 33 and sensor 33 is put in a state to create and send a signal to the process unit 19. Sensor 33 can thus be activated by sensor 17.
    The signal from sensor 17 can also be used by the process unit to be ready to receive input from the proximity sensor 35 as follows: When the sensor 17 sends a signal to the process unit 19 that the dose setting means is set to allow injection of insulin, the process unit 19 is set to a state so that it is ready to receive a signal from the proximity sensor 35 and the proximity sensor 35 is set in a state where it is prepared to create and send a signal to the process unit 19. Sensor 35 can thus be activated by sensor 17.
    Information about the amount of insulin that has been expelled is stored, in step 501, the device's memory 38, preferably in the database 200, as an expulsion event along with the date and time of expulsion.
    In step 502, the proximity sensor detects whether expulsion is taking place in the vicinity of a solid object. The proximity sensor can be configured to continuously measure proximity during expulsion, and that step 502 is after steps 500 and 501 is solely due to the fact that the signal from the proximity sensor 35 can be processed by the process unit after storing the expulsion event. This can conveniently be done immediately after the expulsion has begun or immediately after the expulsion has ended. The presence of a solid object during this time is sufficient to log the expulsion event as an injection.
    If the distance to a solid object is greater than the determined threshold distance T, the event is marked as a priming injection in step 504. If there is a solid object within the threshold distance, the expulsion event is determined to be an injection and the expulsion event is marked as such in step 505.
    The injection event can then be displayed, in step 506, on the device's first display 3. This is conveniently done when the injection has been completed, which is determined by sensor 17 or another sensor, e.g. sensor 33. The user may now be offered the opportunity, in step 508, to label the injection event in step 507 in the same manner as the glucose measurement event may be labeled. The injection event is conveniently shown only on the first display 3 after the injection has been completed. It may be possible to perform marking only if it is done within a certain time, such as. within 10 seconds. After this time has elapsed, the device can turn itself off so that battery power is saved.
    Labeling can, again, include any of the following events: that the user has recently eaten, that the user has recently exercised, or that the user is feeling unwell. For example, by scrolling through a menu, the user can first select "mark" then select one of "MEAL", "MOTION" or "NAUGHTY".
    The injection event in the database 200 can be automatically linked to a blood glucose measurement in the database if injection has been made within a certain time. The time can be 60 minutes, 30 minutes, 20 minutes, 15 minutes or 10 minutes. It is preferred that the time is 30 minutes after or before a blood glucose measurement event. Even more preferably, the time is 30 minutes after a blood glucose measurement event. This is done by storing information linking the injection event to a blood glucose measurement event in the memory 38. The expulsion event in the database 200 may further be stored together with information on whether the expulsion event was an actual injection or a priming expulsion. The electronic logbook may be such that expulsion events marked as priming expulsions are not available to the user via the user interface of the device.
    However, these events may be available after a code is entered or through a data port, or both. This has the advantage that the user does not see the priming events and thus does not confuse the actual injections in the log with the priming events. However, the priming expulsions are still available to a doctor or nurse who wants to check that the user is taking medication as prescribed, or a technician to service the device.
    FIG. 16 schematically shows a database 200 containing two examples of records representing insulin injection events. Event 201 is an example of a priming injection event and event 202 is an example of an actual injection that has been labeled "MEAL" by the user, when the user ingested a meal in connection with the injection.
    The database 200 may be such that expulsions are counted as injections unless a label in the database classifies the expulsion as a priming expulsion in the manner shown inFIG. Alternatively, the database may be such that expulsions are priming events unless they are labeled with a label classifying the expulsion as an actual injection.
    In an alternative embodiment of the method, the electronic log takes into account the length of the needle in the manner shown in FIG. 22.1 In this embodiment, an expulsion is classified as an injection if, when insulin is expelled, the distance from the sensor to the tip of the needle (D1) is greater than the distance from the sensor to a solid object (D2) and whereD1-D2> distance AIn this embodiment, an expulsion is logged as an injection if the needle has penetrated at least A mm into the solid object, i.e. the patient's body. A should be chosen so as to take into account that the needle should penetrate far enough into the body and also to take into account that injection should be possible through clothing, such as a loosely knitted sweater. A can be, for example, 0.1 mm, 0.5 mm, 1 mm, 5 mm or 10 mm, depending on the length of the needle. The length of the needle should be stored in the process unit or in the hardware.
    权利要求:
    Claims (5)
    [1]
    A method of logging drug injections made by a medical device with injection means comprising the steps of: a. Determining the amount of drug expelled from the medical device; b. Storing the time of expulsion together with data from a) in the device's memory; as an expulsion event, c. determining, with a proximity sensor of the device, where the proximity sensor can detect the presence of a solid object in the direction of the injection needle, if expulsion made by the medical device has been made in the vicinity of a solid object, by detecting if there is a solid object within a threshold distance from the medical device, d. mark the expulsion event as an injection event if expulsion takes place in the vicinity of a solid object and as a priming expulsion if expulsion does not occur in the vicinity of an object.
    [2]
    The method of claim 1 wherein the injection events are accessible to the user through a user interface of the medical device and priming expulsions are not available to the user through a user interface of the medical device.
    [3]
    A method according to any one of claims 1 to 2, comprising the further step of the user using the user interface to label an injection event with additional information regarding a selected from the group consisting of a blood glucose value, health status, meal intake and exercise.
    [4]
    A method according to any one of claims 1 to 3 comprising the further step of automatically labeling an injection event with a blood glucose measurement if the blood glucose measurement was made within 30 minutes of the injection.
    [5]
    A portable medical device for injecting drugs comprising means for injecting drugs into a patient, means for automatically storing, in a memory, the amount of drugs injected at a given time as an expulsion event and a proximity tendon which may sense the proximity of a solid object in the same direction as the injection needle by detecting if there is a solid object within a threshold distance from the medical device, where the medical device is configured to label an expulsion event as an expulsion injection occurs near a solid object and label the expulsion event as a priming expulsion if expulsion does not occur in the vicinity of a solid object.
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    同族专利:
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    SE1550571A|SE539856C2|2013-11-20|2013-11-20|Method and apparatus for logging injections of drugs made by a medical device with injection means|SE1550571A| SE539856C2|2013-11-20|2013-11-20|Method and apparatus for logging injections of drugs made by a medical device with injection means|
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