SE1550571A1 - Medical device with safety features - Google Patents

Abstract

ABSTRACT There is provided a method for logging insulin inj ections carried out by a medical device Withinjection means comprising the steps of a) deterrnining the amount of insulin that Was ej ectedby the medical device, b) storing, in the memory of the device, the time of ej ection togetherWith data from a) as an ej ection event, c) deterrnining, With a proximity sensor in the device,said proximity sensor able to sense the proximity of a solid object in the direction of theinjection needle, if ej ection by the medical device takes place in the proximity of a solidobject and e) tagging the ej ection event as an injection event if the ej ection takes place in theproximity of a solid object and as a priming ej ection if the ej ection does not take place in the proximity of an object. 29

Description

BACKGROUND Diabetic 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. Wag requires several different devices to detect this: aids for testing blood glucose levels including aids for taking a blood sample (such as a lancet), an anxiety test strips and blood glucose feeders, a device for injecting insulin and replacement needles and a logbook and pen for recording blood glucose. injections. The diabetic patient must bring this equipment with him, which not only is responsible but also entailed a risk for the patient because% dust of the equipment creates a risk for the patient as incorrect treatment can take place.

Furthermore, since it is very important that the patient really treats himself, it is unfortunate that the self-administration causes minimal response for 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 barbaric medical device which integrates blood glucose supply and insulin injection. It has a lancet to take a blood sample. The lancet and the injection means are placed in the same spirit 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 s5 who 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 showing both the blood glucose level and the amount of insulin that will be injected by the device.

Diabetic patients are accustomed to performing the various steps including blood glucose feeding and insulin injection in a certain order and in a certain way. This helps the patient perform the procedure p5 in a safe manner. There is therefore a need for a things and integrated device.

There is also a need for improved logging of injections. At present, the registration of blood glucose feeds is usually manually by the patient. Manual registration often causes handling errors, s5 can e.g. the patient forgets to insert a value, or insert the wrong value. Automatic logs have been suggested, e.g. and WO2012068214.

Before each injection, it is important that the user "primer" the injection needle, to ensure that there are no air bubbles or stops in the needle. This is done by spraying 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 differentiate between actual injections and primer injections based on the velocity of the liquid 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 a different speed from Ong to running, such a solution cannot be used.

There is therefore a need for improved logging that can differentiate between real injections and priming injections p5 in a safe and easy way. SUMMARY OF THE INVENTION In a first aspect of the invention, there is provided a barbaric medical device for injecting insulin comprising a blood glucose feeder, a first display which can show the glucose content of a blood sample as determined by the blood glucose feeder, means for injecting insulin into a patient to set the amount of insulin to be injected, including a second display showing the amount of insulin to be injected, characterized in that the device comprises an inactivating means which automatically switches off the first display when the means for setting the amount of insulin to be injected is installed so that injection of insulin till5ts.

The device has the advantage that the user does not confuse blood glucose feeds shown on the first display with the installation of the insulin injection device. The user does not believe that the value of the blood glucose supply is the amount of insulin he or she has just injected. P5 s5 sat guided the user through the procedure step by step.

The first display can be an electronic display such as an LCD or an OLED display.

This has the advantage that the display can be made small and can show a starting number of different symbols and figures, as well as moving objects.

The second display can be a mechanical display. Mechanical displays are very reliable and do not require electricity. This has the advantage that the entire injection means can be driven by the user, which is reliable and does not require any batting. The fact that there are no electrical parts also reduces the risk of electric shocks to the user.

The inactivating means suitably comprises a sensor which senses when the means for adjusting the amount of insulin is instant so that injection of insulin is allowed. The sensor can be a position sensor. The sensor is suitably connected to a process unit that controls the first 3 displays. The activating means may also comprise a process unit and connections between the sensor, the process unit and the first display.

The first display may be such that it automatically shuts off when the means for setting the amount of insulin to be injected is set so that injection of insulin is not. The workflow when the device is used is suitably indicated on the device so that the other person makes a mental connection between each of the different steps and the different ways of interacting with the device. This can be achieved in a manner described below.

The housing of the device can therefore be arranged to further separate the various components p5 set as described below. The angle between a line perpendicular to and directed towards the surface of the first display and a line perpendicular to and directed towards the surface of the second display may, for example, be at least 60 °. This has the advantage that the user cannot see both displays at the same time, which further separates the different steps in the process and reduces the risk of errors by the user.

When the device has several different functions and also comprises a lancet intended to be a blood sample, the device may further be designed to further separate the different steps of taking a blood sample, providing a supply of blood glucose value and injecting insulin. Connecting the various functions to the way to interact with the device guides the user in the process. The method of interacting with the device is distinct for each of the steps of taking a blood sample, taking a blood glucose feed, injecting insulin and logging actions. The design of the device makes it easier to remember the correct sequence of the different procedures.

The device may therefore have an elongate housing and further comprise a place for attaching a lancet located in one end of the housing and be arranged so that the means for injecting insulin comprises a container housing intended for connecting an insulin container, where said insulin container can be connected to an injection needle, and there naninda injection needle is coated, when connected to the insulin reservoir, in the opposite spirit of the extended housing, and that an injection trigger is coated in the same arid of the housing as the site for connecting the lancet. 4 The first display is clA conveniently placed on the holster approximately in the middle between the place to connect a lancet and the injection needle.

The angle between the lancet and the injection needle, when connected, is suitably about 160-220 °, more preferably 1700-1900, and most preferably around 1800.

When the device has a location for connection of a lancet and where the blood glucose feeder includes a port for a test strip, the angle between the test strip, when inserted into the port and the lancet, is preferably 0-135 °, more preferably 800-1000, and most preferably about 90 °. °.

When the device has a blood glucose feeder and a port for a test strip, the angle between the test strip, when inserted into the port for the test strip, and the injection needle is preferably 0 - 135 °, more preferably 80 ° -100 °, and most preferably about 90 °.

In a second 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 act, determining, with a proximity sensor in the device, where said proximity sensor can frame the proximity of a solid object in the direction of the injection needle, if expulsion of the medical device takes place near a solid object, mark the injection as an expulsion injection takes place near a solid object and which a priming injection if expulsion does not occur near a solid forem51.

The method can be used to log transactions 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 for p5 s5 set a reliable log for injections and glucose feeds, which improves safety.

It is preferred that expulsions be marked as an actual injection about the distance, when injection takes place, from the front cradle 4 of the container housing to a mold 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 is 0.1 mm.

In one embodiment, the method is such that injection operations are accessible to the user through a user interface p5 the injection device and priming expulsions are not accessible to the user through a user interface p5 the injection device. The priming actions are only accessible through, for example, a data port, or after a code is entered. When set, the priming actions are not visible to the user. This has the advantage that the user does not confuse the priming actions with actual injections in the log.

The priming trades are, however, still available to physicians, nurses and persons who are to perform service on the device.

The user can use an interface to mark actual injections with additional information with a selected Iran group of a blood glucose supply, throat status, intake of m5Itid and exercise. In particular, the method may include the additional step of automatically marking an actual injection with a blood glucose feed if the blood glucose feed is given within 30 minutes of the injection. The advantage of this is that the blood glucose level is affected by insulin injections, meals, exercise and illness. It is thus important that the user, when going through his blood glucose feeds, can take his view of 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 third aspect of the invention, there is provided a medical device invention which is illustrated in carrying out the method according to the invention. Thus, there is also a barbaric medical device for injecting insulin comprising means for injecting insulin into a patient, means for automatically saving the amount of insulin injected at a given time as an injection action and a proximity tendon which may be similar to a solid. direction as the injection needle where the medical device is configured to mark an injection act as an injection if injection occurs near a solid form and mark the expulsion as a priming injection if expulsion does not occur near a form. The sensor can suitably be an infrared sensor. The device may be arranged to mark expulsion as injections when the distance from the front cradle of the container housing to a mold is less than a threshold value T which is described in more detail below. The threshold width can be 200 mm. In an alternative embodiment, the device adapted to perform the method is configured to mark expulsions as injections if the distance from the sensor to the needle tip (D1) is greater than the distance from the sensor to the form (D2) when insulin is injected and where D1-D2 is 0.01 mm. is DEFINITIONS As anyands have, he refers "anyandare" and "patient" to the person anyander the device for testing blood glucose and injecting itself with insulin.

Although insulin is often referred to in the application, the invention can be used with devices for injecting other drugs which 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.

To "mark" means to store additional information about a database record in a database. 7 CORRECT DESCRIPTION OF FIGURES FIG. 1 Jr a schematic view of the medical device.

FIG. 2-3 Jr schematic overview pictures of an injection needle and an insulin container.

FIG. 4-5 show examples p5 the outside of the device.

FIG. 6 shows examples p5 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 p5 how the first and the second display and second features of the device can be arranged.

FIG. 14 shows the threshold reading of a performance 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 p5 database.

FIG. 17 shows various connections to a process unit.

FIG. 18-19 are flow charts showing examples of how blood glucose feeds and injections are logged.

FIG. 20-22 shows how a proximity sensor can be used to classify expulsion actions.

DESCRIPTION OF EXAMPLES OF EMBODIMENTS FIG. 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 is placed by someone else 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 43 of the container 40 of the device shown in FIGS. 2 and 3. The container 40 and the needle 42 are usually provided separately from the device and are not included in this invention. Back to Fig. 1, the vane of 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 comprise a piston 41 which provides for expulsion of medicament through the needle 42. The front of the main part of the container 40 may rest against the front cradle 4 having the container housing 10 as shown in Fig. 14 (note that the needle points in opposite 11511 in Fig. 1 and FIG 14).

The device suitably comprises a blood glucose feeder 9. The device 1 is suitably barbaric. The user can easily take the device with him.

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 which tints the user to hold it in the hand. The cover may have one or more removable parts which serve as grate 8, for example as grate 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 feeder.

Typically, the device 1 p5 is used as follows. 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 second p5 a test strip. The other end of the test strip has continued into the blood glucose feeder through port 2. Based on this value, the user sets the amount of insulin to be injected. The user then injects the amount of insulin and injects himself.

The device 1 has a cross section with at least one display. The display can show different types of information, such as blood glucose feeds, injections, date and time. It is often unfortunate that the injection device, including the display showing the amount of insulin to be injected, is user-driven, i.e. operated by the user. SAdana injection devices have proven to be very reliable because they do not need electricity and the drive mechanisms are very reliable. Example p5 User-driven drive mechanisms for injecting insulin include mechanisms driven by the user by depressing an injection trigger.

Example p5 user-driven mechanisms are known in the art. Examples include US 5,593,390, US 6,221,046 and WO2009027950. A user-driven device can 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 tv5 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 installation.

Fig. 4 shows an example p5 outside the device 1. The first display 3 is mounted in the housing 7. The second display 6 and the dose installation means 5 are also visible5. A part of the cover 7 forms a removable grate cover 8 which protects the injection needle. When the cover cap 8 is placed there, the needle 42 is inside the housing 7.

Fig. 5 initially shows the same thing as Fig. 5, d5 it shows the housing 7 of the device 1 with the grate cap 8 removed to show the container housing 10, the squeegee 42 (with additional protective cap).

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. 1. Preferably, the device 1 is equipped with a blood glucose feeder 9 as shown in FIG. 1. The blood glucose feeder is selectable in the field. Usually Ors blood glucose feed with a disposable test strip that is kanda in the field. The test strip may be of a type that contains one or more chemicals that react with glucose in the blood in a manner that allows the blood glucose level to be fed. The test strip can e.g. be of the standard glucose oxidase / ferrocyanide type where the glucose concentration affects an electric current on a set that can be translated into a blood glucose concentration.

Blood glucose supply from the feeder 9 is started automatically when a test strip is inserted into the port 2. For example, a sensor can be charged 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 blood drop towards the edge p5 the test strip which absorbs the blood and moves it with capillary force along the stick to the place 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 feeder 9, the glucose concentration can be determined and shown on the first display 3 within a few seconds, which means that the user can go to injection mode and set the amount of insulin to be injected. The blood glucose value is usually expressed as mmol / L or mg / L and the device can 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 cradle 4 which restricts the movement of the insulin container 40 in the direction of injection. Vienna 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 l axis. The container 40 can be replaced by a simple set 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 designed in different ways as long as it is suitable for injecting insulin from an insulin container 10 into a patient and can be combined with sensors p5 it sat as described below.

Injections and sensors described below. The means for injecting insulin comprises means 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 of hoisting with which the user may instruct the device 1 to make the second dose setting. It can be, for example, plus / minus buttons or a lever. The rotatable button suitably has screws that improve grip. The amount of insulin to be injected is shown on a display 6, called the second display 6, which is described in more detail below. Typically, the installation values for the second display are 6: 0, 1.0, 1.5, 2.0, 2.5 and s5 further where the numbers represent insulin units, where one unit is 0.01 ml of drug.

The means for injecting insulin also comprises an injection trigger 12. This may be in the form of a button which can be pressed down by the user. The dose button and the injection trigger can be integrated p5 s5 so 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 mechanism operated by the user. 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 so 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 set by turning the dose setting means 5 so that the mechanism 13 can move the piston 41 so that insulin is expelled from the container. And that the dose setting means determines how the piston is to move. The drive mechanism 13 can be combined with an inactivating means which suitably comprises At least one sensor which can karma of motion or installation of the drive mechanism 13. In general, sensors which can karma of motion or installation have a mechanism of choice. The sensor may be a position sensor as the canner of the position has a part of the drive mechanism 13. The At least one sensor may be connected to and arranged to communicate with the process unit 19.

The device suitably has an inactivating means which comprises a sensor 17 which can karma when the dose setting means is instant so that injection of insulin is allowed as described below.

Preferably, the device has a sensor 33 that can detect the amount of insulin that has been expelled from the device. The sensor 33 at- connected to the drive mechanism 13 p5 sA set 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 by rotation has 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 has gear 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 part 27 rotates during injection of insulin which causes rotation has gears 32 and 31. Rotation has the gear 31 and the signal from the magnet sensor 33 is proportional to the rotation has the rotating part 27 and thus against 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 displaying input. The user can obtain information such as the status of the device, the blood glucose level, and the installation of the dosing installation from at least one display. Some embodiments of the device 1 have a single display. In this application, the "first display" must refer to this display.

In a preferred embodiment the device has tv5 or several displays: a first display 3 and a second display 6. In this embodiment the purpose of the second display 6 is mainly to show the installation of the dose setting means, and thus to show the amount of insulin to be injected (or to express themselves more clearly: 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 the blood glucose level is shown on the first display 3. In particular, the blood glucose food level is 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 the blood glucose level.

The first display 3 can be either fitted or turned off. In this application, the term "p5slagen" means that the first display 3 can show letters and numbers, for example the blood glucose value, and "rejected" 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 I5g probability be confused with an actual dose installation or an actual blood glucose value, and duck is considered to be 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) s5, it should be considered off. As a further example, the first display shows several lines containing several lines of the same number, e.g. the number "8", it should also be considered rejected, as this can probably not be mistaken for an actual glucose level or injection. Figs. 7-9 show a set p5 which the second display 6 can be arranged when it is a mechanical display. 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 installation 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 FIGS. 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 installation knob 5 is rotated. The selected dose is shown 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 the selected the value is indicated by a line or an arrow.

In a preferred embodiment, the first display 3 is automatically turned off, by an inactivating means, for example a position sensor, when the dose setting means 5 is instantaneous to inject insulin. Thus, the first display 3 is turned off when the dose setting means is installed p5 - for example - 1.0, 1.5, 4.5 and s5 further, but is inactive when the setting is 0 (zero) or any other setting which results in insulin not can be injected. For example, in addition to installation 0 (zero), there may also be an "off" layer 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 that the user will look at the blood glucose level and think that the food level 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 supply). P5 s5 sat guides the user towards taking the next step in the procedure.

A schematic overview of an example p5 an inactivating means of the device is shown in FIG. When the dose knob is rotated, a sensor 17 which may include a switch 18 sends a signal to the process unit 19 which shuts 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 slot 14 in the rotating part of the dose installation means. Springans! Age Jr sAdant that the device can go into the gap only nal '. dose setting button 5 Jr set to zero.

Another example of a clear sensor 17 is shown in FIG. 6. The circuit breaker 18 Jr is arranged to frame a descending and rotating motion of the sleeve 14 which houses 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 circuit breaker 18. When the user turns the installation knob 5 to adjust the amount of insulin to be injected, the sleeve 14 rotates and moves up in Fig. 6 shows that the part 29 releases the circuit breaker 18 which sends a signal to the process unit 19.

The inactivating means can be arranged in many other ways. S5, for example, a semiconductor-type accelerometer of the type used in mobile telephones (smartphones) can be used to karma of motion or motion 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 adapted by a person skilled in the art so that they can be detected by sensor 17 and sensor 33. S5 shows e.g. US 5,593,390 injection means with cam members which can act on a rake which can act as a sensor 17.

The device can be Adan 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 must 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 Jr was in a position which does not thaw 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 tints to first display 3 slAs on.

In one embodiment, the display automatically shuts off when the injection of insulin has been completed. This can be achieved by the sensor 17 sensing that the dose setting means is returned to zero during expulsion. Referring to FIG. 6, the sleeve 14 moves downward while expelling the drug so that the member 29 reaches the circuit breaker 18 when the trigger 12 is depressed so that the nail engages.

This strikes the first display 3 p5 again. This allows the user to mark the injection document 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 of using the first display 3 to log the injection operation.

In one embodiment, the first display 3 and the second display 6 are not visible at the same time to the user p5 s5 so that the user cannot read off the first display at the same time as the second display. An advantage of this arrangement is that the user cannot confuse the values on the tv5 displays. The tv5 displays can, for example, be geometrically arranged so 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 preferably on different surfaces of the device p5 set as shown in FIGS. 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 p5 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 at least 45 °, more preferred 60 °, more preferred At least 700, more preferred at least 80 ° and most preferred 5 at least 900. Line which is perpendicular to the surface of the display refers to a line which 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 Iran which the user p5 most easily sat looking at the p5 display. When the angle α is 45 ° or more, it is black 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 FIGS. 1 and FIG. 13. The lancet is typically a sharp needle made of surgical steel which can penetrate a small area of skin so that a drop of blood can be obtained. which can be used for glucose feeding. 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 that is sufficient for the lancet to puncture the skin and preferably has a stroke depth of 2-3 mm.

Lancet mechanisms are the choice in the field. 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 noted 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 in a spirit 23 of the housing 7 and the container housing 10 is preferably located in the opposite arid 24 of the extended housing. Furthermore, the injection trigger 12 is preferably located in the same arid 23 of the housing 7 as the location for connecting the lancet 22.

This has the advantage that the user, when he or she is in a position to interact with the injection trigger 12, for example by having a finger positioned to press the injection trigger 12, 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 feeder, the port 2 of the test strip is also preferably located in the middle of the extended shape as shown in Fig. 13. P5 Thus, the glucose feed interaction stalls are located in the center of the housing 7 of the device 1. The center of the surface of the first display 3 is thus located about 50% of the spirit of the housing 7. About 50% includes 30% to 70%, more preferably 35% to 6% and most preferably 40% to 60% of the distance from the shell spirit. Furthermore, the second display is preferably located in one spirit of the housing, preferably the same spirit 23 as the lancet 22. This further separates the first and second displays and mentally connects each display to a particular set of interacting with the device, making it easier to to remember. It also has the advantage that the first display 3 is clearly visible when the device is held with tv5 Under.

To further point out the workflow and allocate the different functions to different parts of the device, the angle 13 between the lancet, when the device has a place to connect a lancet, and the injection needle is preferably around 160 ° -220 °, most preferably around 1800. The lancet 22 and the injection needle points to p5 s5 sat St different hall. Since the injection needle is not included in the invention, the direction of the injection needle is determined by the direction of the container housing 10.

The test strip port includes an opening in the housing and an extended tunnel that guides the test strip to the glucose feeder 9. The cross section of the tunnel is slightly larger than the cross section of the test strip s5 that the test strip is guided to the glucose feeder 9. If the device has a lancet 22 or a location to connect the lancet and a glucose feeder, the test strip port is suitably arranged at the angle γ between the test strip 28, when inserted into the test strip port, and the lancet 22, from 45 ° to 135 °, preferably about 90 °.

When the device has a glucose feeder, the angle between the test strip 28, when inserted into the test strip port, and the injection needle is suitably from 0 to 135 °, preferably about 900 °.

The medical device 1 can be equipped with a proximity sensor 35 connected to a process unit 19.

This can preferably be done without contacting Ors with the object. The proximity sensor should be able to karma of anyone else's body if the skin is bare or covered by clothes. It should also be able to karma of skin of different shades.

The proximity sensor 35 may be a sensor which feeds remotely and which sends a signal to the process unit 19 which can be translated into an output measure. Alternatively, the sensor may be a binary proximity sensor which does not feed the aystand but which creates a detectable signal of a fixed forearm Jr within a threshold distance. The proximity sensor 35 is suitably arranged to transmit a change in a signal when a forearm 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 sending the signal when there is no longer any object within the threshold distance. The sensor may also be arranged to continuously transmit 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 as shown in FIG.

The proximity sensor 35 responds suitably to a shape of a certain thickness so that it does not detect a finger or a small shape which passes through the detection zone, but so that it reacts to a larger shape such as a bone or the user's stomach. The proximity sensor 35 should be such that the sensor of the distance from the medical device to the body or a part of the body has a patient who is lamped to receive 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 the amplitude, frequency, phase shift or shading of an object. The desired signal can be brought about 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 form51.

LED technology is used to sand the IR wave. Examples of proximity sensors are US 8536507 B2 and US 8350216 B2.

The sensor can be used to automatically distinguish between priming injections and real injections as shown in FIGS. 15 and 20-22. This is due to the fact that the user put "primary" injections on the steering wheel, i.e. that he does not prime injections by injecting into a form. When the device 1, with the aid of the proximity sensor 35 [canner of a solid object 50 within a certain distance T, it is assumed that the expulsion act 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 prime 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 scanning zone 51 is also shown5. In this figure, the solid form 50 is not within the threshing state T and the expulsion is logged as a priming injection.

Figures 21, 5, on the other hand, show substantially the same thing as Figure 22, but there is a solid form, 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 sand 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. The sensor 35 is sensed in an approximate direction towards the tip of the needle 42, so that it can be removed when a forearm is in front of the tip of the needle.

The signal from the proximity sensor 35 can be used to distinguish between injection operations 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 operations.

The device comprises a process unit 19 which controls the device. The process unit receives data from the glucose feeder 9, the sensor 17 (which includes the switch 18) for the dose setting means, the expulsion sensor 33 and the proximity sensor 35. The process unit 19 also receives input from the user and controls the first display 3. It can store information in a database 200, for example. 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 an architecture on a nanometer scale, 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 feeds, preferably in the form of a database 200. The process unit 19 can also be connected to a computer through a data port 36, to scan data and to update software stored on the device. Such a connection can be, for example, a USB or a micro-USB connection. The data port 36 can also be a wireless connection such as a Bluetooth or a Wi-Fl connection.

Various different connections to the process unit 19 are shown in FIG. 17. The process unit may have an interface for a circuit breaker 18 of sensor 17 which can when the dose setting means is installed so that injection of insulin tints.

The processing unit 19 may also have an interface for the sensor 33 which detects 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 feeder 9. The battery 34 can be conveniently riveted and replaced by a cover in the housing. The connection for charging may 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 feeder 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 unit but can also be accessed through a wireless network.

The database can be used to log blood glucose feeds 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 feeds 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 first display 3 of the device.

Glucose feeding operations and expulsion operations are stored as records in the database 200. A schematic overview of the database 200 is shown in FIG.

The user can, for example, n5 the electronic logbook by selecting commands in the menu by scrolling through the display using +/- buttons and dA see a list of blood glucose feeds or injection operations, or b5da. The trades can be displayed in chronological order with the most recent trade first. Injections and glucose trades can be marked with additional information, i.e. Additional information regarding these transactions can be stored in the database.

Figs. 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 transactions according to the method of logging of the invention. The steps in FIGS. 15, 18 and 19 are controlled by software stored in the memory and executed by the process unit p5 conventionally set. Which appropriate 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. 15. The electronic log includes a database 200 stored in the memory of the process unit 19. In step 600, an injection operation is stored in the memory of the device. where the injection document contains information about the amount of drug expelled and the time and date for this. During or immediately after expulsion, the proximity sensor 35 detects if there is any solid object 50 near the injection needle direction. If there is no solid forem5I nearby, e.g. if a threshold value for distance to a solid object is exceeded, a decision is made in 601 to mark the expulsion action as a priming action in 602. If there is a fixed object nearby, the action is marked as an injection in step 603. 22 The method is automatically performed by the device. Decision step 601 can be performed in 5 different ways. In the case where the proximity sensor 35 sends a signal which can be translated into an aystAndmAtt, the signal can be processed by the process unit 19 which has stored the threshold value and compared the signal with the threshold value and makes the decision in 601. If it is a binary proximity sensor, the sensor 35 can decide am there is a fixed foremAlinom the threshold distance and sends a signal am this to the process unit 19.

In a preferred embodiment, the threshold reading T can be set relative to a position fixed in front of the injection needle, preferably the front cradle 4 of the container housing 10.

The threshold distance T is fed from the inner surface of the front cradle 4 to where a solid form causes a change in a signal which causes an expulsion action to be classified as a priming injection or an injection as shown in FIG.

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 other observer observes that drug is expelled from the needle at a normal rate, i.e. s5 that no air is left in the n5len and s5 that there is no stop in the n5len. In normal use, it is thus unlikely that priming Ors with n5len near a solid form51.

Appropriately indicated that it includes the fixed lengths of needles (including the needle base) but at the same time sufficient map so that incorrect logging does not occur, 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, when injection occurs when there is no solid form within 200 mm, 100 mm, 50 mm, 40 mm, 30 mm, 25 mm, 20 mm, 18 mm, or 15 mm from the front cradle 4, it is highly probable that the expulsion action is a priming injection.

These ayst5nd tints the fiesta containers, lengths of injection needles and different types of needle bases.

The sensor feed can be performed relatively quickly (under 1 second) and can be performed at any time during expulsion, or immediately after expulsion. Alternatively, feed is performed several times during expulsion. In the following, with reference to Figs. 18 and 19, it is described how the user can use the electronic logbook to log glucose feeds and drug injection operations.

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 feeder 9 which is automatically switched on.

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 sufficient battery power for the subsequent steps to be performed. . The first display 3 is then switched on p5, which shows the user that the device is ready for a blood glucose test. At this stage, the display aptly shows text instructing the user to enter a blood sample, s5 which e.g. "MISSING BLOOD SAMPLES". The user takes a blood sample, apparently by using lancet 22, and places a drop of blood on the test strip. If this is not Ors within an appropriate time frame, such as e.g. 5 minutes, the program in the process unit 19 can switch off the device so that the battery is saved. The integrated blood glucose feeder 9 automatically detects when a blood sample is inserted and feeds the blood glucose level into the blood. Since it takes some time to ora this, the microprocessor can suitably inform the user p5 first display 3 that feed is paying, e.g. by displaying a timer that breaks down or by displaying the text "ANALYZING". 5 seconds is usually sufficient to analyze the blood sample. The device may then display an instruction to the user to remove the test strip from the test strip port 9. The blood glucose feed is stored in step 400 as a blood glucose feed 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 feed in the database. 200. This may include adding data indicating some of the following: if the user has recently been eating, if the user has recently exercised, or if the user is feeling unwell. This procedure is called "marking" the blood glucose supply action. The user can, for example, by scrolling in a menu, first select "ground" and then select one of "MEAL", "EXERCISE" or "BAD". If the user, in step 402, chooses not to add a mark, s5, the device can be automatically switched off in step 404 after a certain period of inactivity, e.g. 10 seconds. The blood glucose supply and injection operations in the database 200 can be accessed by any other user. This can be done by e.g. start the device and select "LOGBOOK" in the menu. The user can d5 read the various blood glucose supply actions 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.

Injections can be stored in the database 200 p5 as follows. 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 instantaneous for injection of insulin, the process unit is set to a state so that it is ready to receive a signal from sensor 33 and sensor 33 sense 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 Iran sensor 17 can be 6N / en anyandas of 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 so that injection of insulin is allowed, the process unit 19 in a state so that it is ready to receive a signal from the proximity sensor 35 and the proximity sensor 35 is set to 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 operation together with the date and time of expulsion.

In step 502, the proximity sensor scans whether expulsion is taking place in the vicinity of a solid object51. The proximity sensor can be configured to continuously supply 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 operation. This can conveniently be done immediately after the expulsion has begun or immediately after the expulsion has ended. The presence of a solid form during this time is sufficient to log the expulsion document as an injection.

If the distance to a fixed object is greater than the determined threshold distance T, the action is marked as a prime injection in step 504. If there is a fixed object within the threshold distance, the expulsion action is determined to be an injection and the expulsion action is marked as such in step 505.

The injection action can then be displayed, in step 506, on the first display 3 of the device. This is done when the injection has been completed, which is emitted by sensor 17 or another sensor, e.g. sensor 33. The user may now be offered the opportunity to, in step 508, mark the injection action in step 507 in the same manner as the glucose feeding action may be marked.

The injection action is apparently only shown on the first display 3 after the injection has been completed. It may be possible to perform marking only if it Ors within a certain time, such as. within 10 seconds. After this time has elapsed, the device can switch itself off so that battery power is saved.

Marking may, in turn, involve some of the following actions: that the user has recently eaten, that the user has recently exercised, or that the user has occasionally. For example, by scrolling through a menu, the user can first select "ground" and then select one of "MEAL", "MOTION" or "ILLAMA".

The injection action in the database 200 can be automatically linked to a blood glucose feed 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 be 30 minutes after or before a blood glucose feeding operation. Even more preferred is the time 30 minutes after a blood glucose feeding operation. This is done by storing information linking the injection action to a blood glucose supply action in the memory 38. 26 The expulsion action in the database 200 can further be stored together with information on whether the expulsion action was an actual injection or a priming expulsion. The electronic logbook may indicate that expulsion actions that are marked as priming expulsions are not accessible to the user via the user interface on the device.

However, these transactions may be available after a code is entered or via a data port, or b5da. This has the advantage that the user does not see the priming actions and thus does not confuse the actual injections in the log with the priming actions. However, the priming expulsions are still available to a Mare or nurse who will check that the user is taking medication as prescribed, or a technician who will perform service on the device.

Fig. 16 schematically shows a database 200 containing two examples of records representing insulin injection operations. Trade 201 is an example p5 a priming injection action and action 202 is an example p5 an actual injection that has been marked with "MALTID" by the user, d5 the user ingested a meal in connection with the injection.

The database 200 may be such that expulsions are tracked as injections unless a mark in the database classifies the expulsion as a priming expulsion p5 set as shown in FIG. 16. Alternatively, the database may be Adan that expulsions Jr priming actions 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. In this embodiment, an expulsion is classified as an injection when insulin is expelled, the distance from the sensor to the tip of the needle (D1). greater than the distance of the Iran sensor to a solid object (D2) and where D1-D2 distances AI in this embodiment, an expulsion is logged as an injection has penetrated at least A mm into the solid object, i.e. the patient's body. A should be chosen so that the sight 27 is taken so that the needle will penetrate sufficiently far into the body and also5 to take the sight so that injection can be honored through clothes, such as a lost 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 must be stored in the process unit or in the hardware. 28

Claims (6)

1. Method for logging insulin injections carried out by a medical device With injection means comprising the steps of a) deterrnining the amount of insulin that Was ej ected by the medical device, b) storing, in the memory of the device, the time of ejection together With datafrom a) as an ej ection event, c) deterrnining, With a proximity sensor in the device, said proximity sensor ableto sense the proximity of a solid object in the direction of the injection needle,if ej ection by the medical device takes place in the proximity of a solid object, d) tagging the ejection event as an injection event if the ej ection takes place in theproximity of a solid object and as a priming ej ection if the ejection does not take place in the proximity of an object.

2. The method of claim 1 Where an ejection is tagged as a real injection if, When insulinis injected, the distance from the site of attachment for a needle to an object is less than 200 mm.

3. The method of claim 1 Where an injection is recorded as a real injection if, Wheninsulin is injected, the distance from the sensor to the tip of the needle (D1 ) is larger than the distance from the sensor to an object (Dg )and Where D1-D22 0.1 mm

4. The method according to any one claims 1-3 Where the injections events are accessibleto the user thought a user interface on the inj ector device and the priming ej ections are not accessible to the user via a user interface on the injector device. 27

5. The method according to any one claims 1-4 comprising the additional step of the userusing a user interface to tag a real injection event With an additional inforrnationregarding one selected from the group consisting of a blood glucose measurement, health status, taking a meal and exercise.

6. The method according to any one claims l-5 comprising the additional step ofautomatically tagging a real injection event With a blood glucose measurement if the blood glucose measurement has been made Within 30 min of the injection. 28