US20180289901A1

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Publication number: US20180289901A1
Application number: US15/481,087
Authority: US
Inventors: David Tobias Bøggild-Damkvist; Rasmus Tjalk-Bøggild
Original assignee: Nordic Healthcare Advisory Aps
Current assignee: Nordic Healthcare Advisory Aps
Priority date: 2017-04-06
Filing date: 2017-04-06
Publication date: 2018-10-11
Also published as: EP3606582B1; EP3606582A2; WO2018185727A2; US20200030551A1; US11458259B2; ES3034585T3; WO2018185727A3; DK3606582T3

Abstract

The present invention relates to a position determination device (100) (and system) for determining and registering an injection location of a liquid drug administered on a body part of a user, wherein the position determination device (100) (and system) comprises a position determination element (110) configured to provide a position signal representing a current location of the position determination device (100), and one or more processing units (150) configured to derive data representing an actual injection location based on the user in response to a current location being determined by the position determination unit (110).

Description

FIELD OF THE INVENTION

The invention relates generally to embodiments of a position determination device for and method of determining and registering an injection location of self-administered liquid drug administration on a user. Further the invention relates to calibration of such position determination devices.

BACKGROUND OF THE INVENTION

A growing number of people have a condition involving liquid drug delivery administration where the user themselves deliver the relevant liquid drug (i.e. self-administration) by injection at an appropriate injection location or site using an injection device or the like.

Preferably, the liquid drug to be delivered is insulin but the invention is applicable to all liquid drug delivery devices where a user administers a drug on at least a somewhat regular basis, e.g. several times a day or less frequent like a number of times in a week, etc., by injection into an appropriate body part.

Other examples of user-administered liquid drugs includes MS therapies with interferons and immune suppressives (e.g. like Avonex, Rebif, Copaxone etc.), different hormone therapies (growth hormone, anti-/hormone follow-up treatments to breast or prostate cancer, etc.).

In such recurring self-injection regimens it is very important that the user does not inject the drug at the same location every time or too often as this may cause ‘pockets’ of the drug to gather under the skin, cause hard lumps, and/or cause extra fat deposits to develop as well as the onset of lipohypertrophy and/or similar skin/tissue damages (that may change the way the liquid drug is absorbed by the body at that location), and so on.

Therefore educating the user in injection techniques is often an important part of such treatment regimens and according to a current best practice in the US and the rest of the world it is recommended to change/rotate between injections locations (see e.g. Mayo Clin Procedings, September 2016; 91(9):1231-1255, Anders H. Frid, MD; Gillian Kreugel, DSN; Giorgio Grassi, MD; Serge Halimi, MD; Debbie Hicks, DSN; Laurence J. Hirsch, MD; Mike J. Smith, DSN; Regine Wellhoener, MD; Bruce W. Bode, MD; Irl B. Hirsch, MD; Sanjay Kalra, MD; Linong Ji, MD; and Kenneth W. Strauss, MD: http://www.mayoclinicproreedings.org/article/S0025-6196(16)30321-4/abstract). Furthermore, it may be recommended to inject not closer than 3 or even 1 cm (or some other distance(s)) of a previous injection location; at least within a given timeframe.

To remember and keep track of the injections, users may use certain memory systems and/or simple schematics, but compliance has been shown to usually be lowered over time, in particular for user administered injection schemes.

A typical example of patient education material is found e.g. at: http://www.cc.nih.gov/ccc/patient_education/pepubs/subq.pdf

However, there is scientific evidence that a significant number of users may still forget where the last injection was made (see e.g. Diabetes Meab. 2013 October: 39(5): 445-35, Blanco M, Hernandez M T, Strauss K W, Amaya M., https://www.ncbi.nlm.nih.gov/pubmed/23886784). Furthermore, even if rotating perhaps some body locations are still used more frequently than others.

Some users may also be relatively young children, which may have a harder time sticking rigorously to a recommended rotation scheme and/or remembering it fully all the time.

Patent application WO 2015/085019 discloses a device and method to encourage injection site rotation and prevent lipodystrophy from repeated injection to a body area where optical devices employing optical mouse or projection technology help locate and/or distribute injection sites within a body area and where a mobile phone app tracks injections and locations to select next injection site.

Patent application WO 2014/161952 discloses a dose logging device for a drug delivery device where a magnet is used to determine an amount of drug expelled from a reservoir for the drug delivery device.

Patent application WO 2015/136564 discloses an add-on module for monitoring and control of compliance to therapy for injectable drugs contain in pre-filled syringes having means for controlling an amount of injectable liquid and a rate of injection and means for controlling an inclination at which the injection is made with respect to skin surface in the area of injection and means for warning a user of possible anomalies during injection.

Patent application WO 2014/023763 discloses a pen-type drug injection device and add-on monitoring module for monitoring and logging dose setting and administration where the module comprises a processor and a sensor for determining the quantity of medicament that has been delivered and wherein the sensor is arranged to detect movement of a drive screw of the injection device during medicament delivery.

There is therefore a need for improved injection location handling and/or management.

It would also be a benefit to provide precise data about actual injection location(s).

SUMMARY OF INVENTION

It is an object to alleviate at least one or more of the above mentioned drawbacks at least to an extent.

Furthermore, it is an object to provide improved injection location handling and/or management.

Additionally, it is an object to enable precise data relating to actual injection location(s).

A first aspect of the invention is defined in claim1.

According to the first aspect of the present invention is provided, a position determination device for determining and registering an injection location of a liquid drug administered on a body part of a user, where the position determination device comprises a position determination element configured to provide a position signal representing a current location of the position determination device, and one or more processing units configured to derive data representing an actual injection location on the user in response to a current location being determined by the position determination unit.

In this way, specific data is automatically obtained of where (and potentially when) one or more drug injections actually have been made. This enables improved injection location handling and/or management of the drug administration and in particular reliable data-logging of actual drug injection locations.

In some embodiments, the improved injection location handling and/or management of the drug administration includes using knowledge of previous injections locations to recommend the next appropriate injection location taking this knowledge into account—e.g. to adhere to and comply with a rotation scheme, a regimen, schedules for administering the drug, etc. and to improve drug absorption and avoid the drawbacks mentioned earlier, to actively warn a user if the user is about to use an injection location that is too close to an earlier injection location (e.g. within a given time-frame), and further on, as will be explained further in the following.

In some embodiments, the actual injection location may e.g. be calculated in the following manner: From a known or predetermined starting position, the position determination element is reset to represent a zero-length movement vector. As the position determination device is moved, a representation of the distance moved is updated in according thereto to produce a 3D movement vector until the position determination device is moved (e.g. via one or more anchor points as disclosed herein but not necessarily) by the user to a final injection site whereby a position of the injection site may be determined.

In some embodiments, the one or more processing units is/are configured to derive the data representing an actual injection location on the user in response to a current location being determined by the position determination unit in response to the user administering the liquid drug using a liquid drug administration device. In this way, the action of the user specifically causing administration of the liquid drug is tied directly to obtaining the actual injection location, which increases the reliability of the obtained injection location data. The liquid drug administration device may be of any suitable type that is used by a user or a medical professional to administer a liquid drug at an appropriate injection location on a given user. The liquid drug administration device may e.g. be an insulin administration device such as an insulin pen (simple or ‘smart’), a syringe, an insulin doser, an insulin pump, etc. Alternatively, the liquid drug administration device may e.g. be a syringe or other drug delivery device for delivery of interferons, immune suppressives, hormone therapies, or other drugs or liquids.

In some embodiments, the position determination device is further configured to be (e.g. releasably) secured to a liquid drug administration device. In this way, a user can use the liquid drug administration device to administer the liquid drug as he/she normally would while obtaining reliable data of where one or more drug injections actually have been made. Furthermore, additional capabilities or ‘intelligence’ may readily be provided to a simple (‘non-smart’) liquid drug administration device such as a disposable liquid drug administration device such as certain simple insulin pens or other. This also ties movement of the liquid drug administration device directly to movement of the position determination device, which can increase accuracy and/or reliability of the injection location determination.

In some embodiments, the position determination device has a generally hollow cylindrical shape with an opening or cut-out configured to receive at least a part of a liquid drug administration device when being secured to this. This enables simple attachment to (and e.g. detachment from) the liquid drug administration device. To facilitate this further, the position determination device may e.g. have pliable walls enabling it to ‘snap’ onto the liquid drug administration device (and to be released therefrom again).

In some further embodiments, the locking or attachment mechanism is further configured to releasably engage with a mating or corresponding locking or attachment mechanism of a cap of the liquid drug administration device thereby enabling the cap to be attached to the position determination device (even when the position determination device is attached to the drug administration device), i.e. the position determination device is (once in place) located between the drug administration device and the cap. This enables the cap still to be used for protection even when the position determination device is attached to the liquid drug administration device.

In some embodiments, the position determination device comprises a main body or housing (preferably comprising the position determination element, the one or more processing units, and other functional elements as disclosed herein) and a first separable and interchangeable part (a fitter component) wherein the first separable and interchangeable part is selected from a set of a plurality of separable and interchangeable parts, where each separable and interchangeable part of the set is configured to receive, attach with, and/or otherwise accommodate a different liquid drug administration device. In some further embodiments, the main body or housing and the first separable and interchangeable part, when joined or attached together, are configured to receive and/or accommodate a first liquid drug administration device, e.g. by enclosing the first liquid drug administration device when the main body or housing and the first separable and interchangeable part are joined or attached together. Alternatively, the first separable and interchangeable part is configured to connect with the first liquid drug administration device and to connect with the main body or housing, i.e. the first separable and interchangeable part is an intermediate way of connecting the first liquid drug administration device to the main body or housing of the position determination device. In this way, only the first separable and interchangeable part/the fitter component needs to be chosen or changed to accommodate a different type of liquid drug administration device while keeping the main body or housing of the position determination device (preferably comprising the position determination element, the one or more processing units, and other functional elements as disclosed herein) the same. The fitter component may e.g. be simple casing produced in a wide set of variations with the purpose of locking on to or connecting with the specific drug administration device (or a set or a class of specific similar drug administration devices) and providing a vehicle that the main part of the position determination device attaches to by one or more securing elements, e.g. a set of groves, magnets, or other suitable fixation mechanisms.

In some embodiments, the position determination device further comprises a wireless communications unit configured to automatically transmit the position signal or the derived data representing an actual injection location to a separate electric device (and/or the liquid drug administration device). This communication may be realized using standard such as e.g. Bluetooth, Bluetooth low energy (BLE), Near Field Communications (NFC), wifi, etc. to facilitate communication with a general (or special) purpose computation and communication device (e.g. a smartphone, a tablet, a laptop, a computer, etc.).

In some embodiments, the position determination device is configured to derive the data representing an actual injection location one the user in response to response to a current location being determined by the position determination unit in response an actual action of the user activating the liquid drug administration device to administer the liquid drug triggers deriving the data representing an actual injection location. In this way, precise registration of the injection location is provided as the moment of deriving the data is tied directly to the actual drug administration.

In some embodiments, a mechanical or remote sensor is attached directly to, or attached in connection with, an activation button or element of the liquid drug administration device where the mechanical or remote sensor is configured to detect movement or activation of the activation button or element of the liquid drug administration device. In some alternative embodiments, a sensor is configured to detect activation of the activation button or element by other ways than movement.

A mechanical sensor may e.g. be physically attached or parallel to the activation button or element. A remote sensor could measure the distance to the activation button or element and determine any changes in the activation button or element's position in relation to the position determination device.

In some embodiments, the position determination device further comprises a sound sensor configured to register one or more distinct sounds caused by the drug administration device when operated by a user to release or administer a drug dosage as an actual action of the user and wherein the position determination device is configured to trigger deriving the data representing an actual injection location in response to registering and identifying the one or more distinct sounds. Such distinct sounds are common e.g. among insulin administration devices and other types of liquid drug administration devices to allow users with impaired sight to hear when the dosage is released. Alternatively, or in addition, the position determination device further comprises a vibration sensor (e.g. a (3 axis) accelerometer or other movement detector) configured to register one or more distinct vibrations caused by a user operating the liquid drug administration device to release a drug dosage as an actual action of the user and wherein the position determination device is configured to trigger deriving the data representing an actual injection location in response to registering and identifying the one or more distinct vibrations. Accordingly, registration and identification of sound and/or vibrations signals or profiles may be used to reliably capture the actual release of the liquid drug by the liquid drug administration device. Predetermined sound and/or vibration profiles (e.g. for several different liquid drug administration devices) may be stored in a suitable memory and/or storage (e.g. of the position determination device or an external device) and be used to compare with obtained sound and/or vibration signals to determine whether and when the liquid drug is actually released or administered.

In some embodiments, the position determination device further comprises

- a memory and/or storage comprising data representing at least one previous injection location,
- at least one indicator element, configured to signal to the user
- that a current location of the position determination device, as determined by the position determination element, is at a location where it is acceptable and/or advisable to perform an injection taking into account at least the data representing at least one previous injection location, and/or
- that a current location of the position determination device, as determined by the position determination element, is at a location where it is not acceptable and/or not advisable to perform an injection taking into account at least the data representing at least one previous injection location.

Accordingly, improved injection location handling and/or management of the drug administration is provided that includes using knowledge of previous injections locations to recommend the next appropriate injection location taking this knowledge into account—e.g. to adhere to and comply with a rotation scheme, a regimen, schedules for administering the drug, etc. and to improve drug absorption and avoid the drawbacks mentioned earlier, to actively warn a user if the user is about to use an injection location that is too close to an earlier injection location (e.g. within a given time-frame), and further on.

Alternatively, the data representing at least one previous injection location is stored in a memory and/or storage of an external device and the position determination device may then simple receive a (ok and/or not ok) signal from the external device.

An indicator element may e.g. be or comprise one or more of a light emitter, an LED, a sound emitter, vibration or haptic unit, graphical element(s) as part of a graphical user interface displayed on a display or similar, etc. or any other suitable emitter or indicator capable of signaling suitable indications to the user.

In some embodiments, the position determination element comprises at least one gyroscope (may also be referred to a gyrometer) and/or at least one accelerometer configured to provide the position signal representing a current location of the position determination device. In some further embodiments, the position determination element comprises three gyroscopes and three accelerometers aligned orthogonally corresponding to the three primary axes of the device frame. Such setups allow the position determination device to capture accelerations and rotations for a device being moved freely in 3D space.

In some embodiments, the one or more position determination elements comprise a combination of the exemplary embodiments comprising one or more elements adding further reference point(s) and parameter(s) for determining the injection location given above and as disclosed herein. This will add further reference point(s) and parameter(s) for determining the injection location thereby further increasing the quality and/or reliability thereof.

In some embodiments, the permanent or electromagnet source, the sound reflecting source, the sound emitting source, the light source, the reflector, and/or the radio signal source is located in a cap of a liquid drug administration device. In this way, the respective element(s) (to be kept stationary at least during determination of the injection location), are readily available at the time of injection. The element(s) (e.g. the cap) may e.g. simply be placed on a table or other during determination of injection location thereby providing a fixed reference point for use in determination of the injection location.

In some embodiments, the position determination device is further configured to register an actual amount of administered liquid drug and/or a time-stamp when or in connection with deriving data representing an actual injection location. In this way, an accurate data or diary log may automatically be provided that improves daily diabetes administration for the user and/or as well as providing data for improving treatment by healthcare professionals, for academic use, etc.

In some embodiments, the position determination device further comprises an image sensor or other sensor element configured to detect an amount of liquid drug being administered by the liquid drug administration device. In this way, dosage data may be collected (and communicated further on) by the position determination device in situations where a liquid drug administration device otherwise does not support this. In some embodiments, this is achieved by using an image sensor that is e.g. hand held by the user or mounted on e.g. a pair of glasses or elsewhere on the user. The image produced by the image sensor would then e.g. be digitally processed to identify the liquid drug administration device, an injection region or location, and a location of the liquid drug administration device in relation to the injection region or location. This may be achieved by using any suitable image processing techniques such as but not limited to e.g. edge detection, ANN (artificial neural networks), DNN (deep neural networks), or some combination or derivation hereof. In some embodiments, image recognition may be used to augment or supplement the position determination techniques described herein. The image recognition could e.g. add a second source of data to the movement based and/or other detector based technique(s) disclosed herein thus improving precision and/or reliability further. In other embodiments, image recognition could be used to determine actual starting points of the movement of hand and drug administration device thus reducing the need for fixed calibration.

In some embodiments (e.g. in combination with registering release or administering a drug dosage as described above and disclosed herein), the position determination device further comprises a sound sensor configured to register one or more distinct sounds caused by a user operating the liquid drug administration device to increase and/or decrease a drug dosage as one or more actual actions of the user and wherein the position determination device is configured to derive an amount of liquid drug being administered by the liquid drug administration device in response to registering and identifying the one or more distinct sounds and/or a vibration sensor (e.g. a (3 axis) accelerometer or other movement detector) configured to register one or more distinct vibrations caused by a user operating the liquid drug administration device to increase and/or decrease a drug dosage as one or more actual actions of the user and wherein the position determination device is configured to detect an amount of liquid drug being administered by the liquid drug administration device in response to registering and identifying the one or more distinct vibrations.

In some embodiments, the position determination device is further configured to

- register a starting position in response to the user moving the position determination device to a pre-determined starting position,
- register a location of an anchor position in response to the position determination unit determining the movement from the starting position to the anchor position,
- register a location of the actual injection location in response to the position determination unit determining the movement from the anchor position to the injection location.

In some embodiments, the position determination device is further configured to

- recommend the anchor position and/or recommend the location of the actual injection location in response to stored and/or received data representing a rotation schema (e.g. stored as data in the position determination device or in a separate electric device and being received therefrom) taking into account data representing one or more previously registered actual injection locations.

In some embodiments, the position determination device is further configured to

- register a starting position when the user has moved the position determination device to a starting position,
- if used, register a region in connection with the starting position defining a region suitable for receiving injections,
- register one or more anchor points, by determining their relative position in relation to the starting position, and for each anchor point registering a region defining a region associated with the given anchor point being suitable for receiving injections.

In some embodiments, the liquid drug is one selected from the group consisting of: insulin, a drug for multiple sclerosis therapy with interferons and immune suppressives (e.g. like Avonex, Rebif, Copaxone etc.), a drug for hormone therapy, a drug for growth hormone therapy, and a drug for hormone/anti-hormone follow-up treatment to breast or prostate cancer.

In some embodiments, the position determination device is integrated with a liquid drug administration device and wherein the derived data or position signal representing an actual injection location is transferred to at least another electric element of the liquid drug administration device.

In some embodiments, the position determination device is for determining and registering an injection location of self-administered liquid drug administration on a user.

In some embodiments, the position determination device is for determining and registering an injection location of administered liquid drug administration on a user administered by a medical professional.

According to some embodiments, the position determination device as disclosed herein may be used in connection with a dock or similar to recharge and/or transfer information and/or data as generally known.

According to a second aspect is provided a position determination system for determining and registering an injection location of a liquid drug administered on a body part of a user, wherein the position determination system comprises a position determination element configured to provide a position signal representing a current location of the position determination device, and one or more processing units configured to derive data representing an actual injection location on the user in response to a current location being determined by the position determination unit.

In some embodiments, the position determination system further comprises a liquid drug administration device and wherein the one or more processing units are configured to derive the data representing an actual injection location based on a current location determined by the position determination unit in response to the user administering the liquid drug using the liquid drug administration device.

In some further embodiments, one or more of the elements of the system as described above correspond(s) to one or more similar elements of the position determination device or one or more similar elements as described in connection with the position determination device as disclosed herein.

Another aspect of the present invention is a use of a position determination device as disclosed herein and/or according to any one of claims1-25 (and combinations thereof) or the position determination system as disclosed herein and/or according to claim26 and/or27 to register one or more locations of actual injection locations.

According to another aspect of the present invention is provided an electronic device configured to collect and/or obtain data representing a history of actual injection locations (e.g. obtained or provided by a position determination device as disclosed herein) where one or more processing units of the device is/are configured to display a graphical representation on a display of at least a part of the data representing a history of actual injection locations as a ‘heat map’ or similar where the individual values (location e.g. together with further relevant information like time of injection, actual amount of injected liquid drug, etc.) are represented and/or displayed as colors according to a color scheme superimposed on a picture or a graphic representation of the overall injection area(s), e.g. like the torso, the thighs, upper arms, or what other injection area the user has defined, etc. The values may e.g. be stored in a matrix data structure and/or any other suitable data structure. The color scheme may e.g. be one from green to red where a given injection location is marked yellow if it was taken in (too) close proximity (e.g. within 1 or 3 cm, or as chosen by the user) to one another injection location made within a predetermined time (e.g. a week or other timeframe as e.g. determined by the user), and red if it is in (too) close proximity to 2 or more injection locations, and green in all other cases.

The heatmap may be displayed to a user prior to the user performing an injection thus enabling the user to check an intended injection location in relation to previous injection locations.

In a recommendation mode, the device itself may show status of injection locations based on the same color scheme or recommend locations based on the chosen rotation principles and e.g. assessment of possible lipohypertrophy by medical professionals thereby guiding the user to a suitable injection site. In some further embodiments, this involves showing injection history, areas to avoid because of lipohypertrophy, and/or areas to inject in. The aspect of displaying previous injection locations like this may be used independently of the described aspects and embodiments of the position determination device as disclosed herein although they together work especially well.

Definitions

All headings and sub-headings are used herein for convenience only and should not be constructed as limiting the invention in any way.

The use of any and all examples, or exemplary language provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a schematic block diagram of embodiments of a position determination device;

FIGS. 2a-2dschematically illustrate different views of one exemplary embodiment of a position determination device e.g. as illustrated inFIG. 1;

FIG. 3aschematically illustrates a perspective view of the position determination device ofFIGS. 2a-2dbeing secured to a liquid drug administration device;

FIG. 3bschematically illustrates a perspective view of the position determination device and the liquid drug administration device ofFIG. 3abefore the position determination device is secured to the liquid drug administration device;

FIG. 4 schematically illustrates a flow chart of one embodiment of position determination by a position determination device e.g. as shown inFIGS. 1 to 3band8 to9 and embodiments thereof;

FIG. 5 schematically illustrates a flow chart of one embodiment of a method of suggesting an injection location;

FIG. 6 schematically illustrates a flow chart of one embodiment of a calibration method of a position determination device, e.g. as shown inFIGS. 1 to 3b;

FIG. 7 schematically illustrates a separate electric device displaying a ‘heatmap’ view or similar of earlier injections;

FIG. 8 schematically illustrates an embodiment of a locking mechanism for attaching an embodiment of a position determination device to a drug administration device;

FIGS. 9aand 9bschematically illustrate an embodiment of the position determination device attached to a drug administration device and by itself;

FIG. 10 schematically illustrates an exemplary sound signal emitted from a liquid drug administration device when incrementing and decrementing10 drug dosage units, respectively;

FIG. 11 schematically illustrates an example of the vibrations emitted by a liquid drug administration device, as measured by an accelerometer or similar, when increasing the drug dosage by 7 units; and

FIGS. 12aand 12bschematically illustrate an embodiment of a position determination device comprising a main or overall body or housing that is separable into two parts with one part being an interchangeable fitter component that is adapted to receive or attach to a specific liquid drug administration device.

DETAILED DESCRIPTION OF THE INVENTION

Various aspects and embodiments of a position determination device for and methods of determining and registering an injection location of administered liquid drug administration on a user and calibration of such position determination devices as disclosed herein will now be described with reference to the figures.

When/if relative expressions such as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical”, “clockwise” and “counter clockwise” or similar are used in the following terms, these refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only.

In that context, it may be convenient to define that the term “proximal direction” in the appended figures is meant to refer to the direction of the position determination device (and its associated or integrated liquid drug administration device) that normally, during use, would point towards an injection element of the liquid drug administration device, as depicted e.g. inFIGS. 2aand 3a-3b, whereas the term “distal direction” is meant to refer to a direction parallel and opposite to the proximal direction.

FIG. 1 illustrates a schematic block diagram of embodiments of a position determination device.

Shown is one embodiment of aposition determination device100 and a liquiddrug administration device200. Theposition determination device100 may e.g. be integrated with the liquiddrug administration device200 or alternatively be (releasably) attached or secured to the liquiddrug administration device200, e.g. as shown and explained further in connection withFIGS. 3a-3band8-9 or alternatively of another type.

The liquiddrug administration device200 may be of any suitable type that is used by a user or a medical professional to administer a liquid drug at an appropriate injection location on a given user. The liquiddrug administration device200 may e.g. be an insulin administration device such as an insulin pen (simple or ‘smart’), a syringe, an insulin doser, an insulin pump, etc. Alternatively, the liquid drug administration device may e.g. be a syringe for delivery of interferons, immune suppressives, hormone therapies, or other drugs or liquids.

Theposition determination device100 comprises one or moreposition determination elements110 and in this particular and other embodiments, one ormore processing units150, at least one digital memory and/orstorage160, and at least onecommunications unit120, preferably one or more standardized wireless communications units e.g. like Wi-Fi, Bluetooth, NFC, etc. communications units.

If theposition determination device100 is integrated with the liquiddrug administration device200 they may share one or more elements, such as the processing unit(s), the digital memory/storage, and/or the communication unit(s).

Further shown is a separateelectric device300 comprising its own one ormore processing units150′, at least one digital memory and/orstorage160′, at least onecommunications unit120′, and optionally adisplay310.

Preferably, the position determination device100 (and/or the liquid drug administration device200) may wirelessly communicate or exchange data and information with the separateelectric device300.

The separateelectric device300 may e.g. be a mobile communications and/or computation device such as a smartphone, a tablet, a laptop or PC, etc. or a separate dedicated special purpose device, such as a data-logger or the like.

Theposition determination device100 is for determining and registering an injection location of (e.g. self-administered) liquid drug administration on a body part of a user as will be explained in the following and as disclosed herein.

According to an aspect of the present invention, theposition determination element110 is configured to provide, during use, a position signal representing a current location of theposition determination device100 and the one ormore processing units150 is/are configured to derive, during use, data representing an actual injection location on the user in response to a current location being determined by theposition determination unit110. Alternatively (or in addition), theposition determination device100 is configured to transmit, via thecommunications unit120, the position signal representing directly or indirectly the current location to the separateelectric device300, the liquiddrug administration device200, and/or another device instead of deriving the data representing an actual injection location. The derivation of the data may e.g. then be performed by the receiving device.

According to a further aspect of the present invention, theposition determination device100 may be attached or secured and (releasably) locked in relation to thedrug administration device200 with the use of a locking mechanism according to various embodiments (see e.g.701 inFIGS. 8 and 9 for one embodiment) at a predetermined location on and/or predetermined orientation in relation to thedrug administration device200. In this way, it is ensured by such a locking mechanism that a distance from theposition determination device100 to the needle of thedrug administration device200 is always known a priori. This avoids (or at least reduces) the need for re-calibration every time theposition determination device100 is attached to thedrug administration device200.

In some further embodiments, theposition determination device100 attaches to thedrug administration device200 like a cap of thedrug administration device200 normally would when theposition determination device100 is not present, i.e. the locking mechanism of theposition determination device100 corresponds to the locking mechanism of the cap in that they will be the same or at least similar or compatible. This ensures that theposition determination device100 can be attached or secured to thedrug administration device100 in a reliable way, since the locking mechanismposition determination device100 is a ‘copy’ of or at least being corresponding to the locking mechanism of the cap.

In some further embodiments, theposition determination device100 is further configured to allow the cap of thedrug administration device200 to be attached to theposition determination device100 rather than directly to thedrug administration device200 itself when theposition determination device100 is attached or secured to the drug administration device200 (see e.g.702 inFIGS. 8 and 9). This ensures that the cap may still be attached thereby protecting the relevant parts of thedrug administration device200 in a usual way.

The actual injection location may e.g. be calculated in the following manner: From a known or predetermined starting position, theposition determination element110 is reset to represent a zero-length movement vector. As theposition determination device100 is moved, theposition determination element110 update its internal representation of the distance moved to produce a 3D movement vector. When theposition determination device100 is moved to an anchor point, this movement vector is compared to the calibrated vectors to determine which anchor point theposition determination device100 is at. In addition, data from theposition determination element110 may e.g. be used to determine the relative position in relation to the torso or the limb where the anchor point is located. The border of the injection area around the anchor points is calibrated e.g. as described in connection withFIG. 6. Using the calibrated area, the anchor position, the starting position, and the internal movement vector, the exact position of the injection site may be determined when the position determination element100 (and e.g. the liquiddrug administration device200 as attached or integrated) is moved by the user to a final injection site.

In this way, specific data is obtained of where (and e.g. when) one or more drug injections actually have been made. This enables improved injection location handling and/or self-management of the drug administration including e.g. using knowledge of previous injections locations to recommend the next appropriate injection location taking this knowledge into account—e.g. to adhere to and comply with a rotation scheme, a regimen, schedules for administering the drug, etc. and to improve drug absorption and avoid the drawbacks mentioned earlier, to actively warn a user if the user is about to use an injection location that is too close to an earlier injection location (e.g. within a given time-frame), and further on, as will be explained further in the following.

Depending on specific circumstances, the location signal or signals as obtained by the one or moreposition determination elements110 may comprise a certain amount of (background) noise. In some embodiments, theposition determination device100 comprises elements to at least reduce or mitigate such noise. According to some such embodiments, the one or moreposition determination elements110 comprises at least one accelerometer or other suitable movement detection element where movement sensor data or one or more movement sensor signals is used to determine whether theposition determination device100 is stationary or in movement (e.g. in relation to a background measurement of standard gravity g).

For portions of the obtained signal that is determined to reflect a movement of theposition determination device100, the signal will contain first an acceleration (indicating a start of the movement) and subsequently a deceleration (indicating an end of the movement) back to a stationary position. This may be compared against a priori knowledge of human arm movement to fit the noisy signal to a noise-free curve and thereby extract a signal with at least reduced noise that then may be used for determination of the injection location as disclosed herein.

In some embodiments, theposition determination device100 may automatically transmit, using thewireless communications unit120, the derived data representing an actual injection location (or alternatively a signal representing the actual injection location as obtained by the one or more position determination elements110) to the separateelectric device300 and/or the liquiddrug administration device200. In this way, the data relating to actual injection is readily made available and may be used for various purposes e.g. as disclosed herein. Alternatively, theposition determination device100 may automatically transmit, using thewireless communications unit120, a signal representing the actual injection location or a signal representing current location or subsequent current locations as obtained by the one or moreposition determination elements110 to the separateelectric device300 and/or the liquiddrug administration device200. In this way, the separateelectric device300 and/or the liquiddrug administration device200 can derive the data representing an actual injection location.

In some embodiments, the data representing an actual injection location is derived in response to the user administering the liquid drug using the liquiddrug administration device200. This may in some embodiments be an actual action of the user actually activating the liquiddrug administration device200 to administer the liquid drug that triggers deriving the data representing an actual injection location.

In some embodiments, theposition determination device100 may also comprise at least one indicator element (see e.g.202,203, and204 inFIGS. 2a-3band9).

The at least one indicator element (e.g. light, LED, sound emitter, etc.) may be configured to signal to the user, during use, that a current location of theposition determination device100, as determined by theposition determination element110, is at a location where it is acceptable or advisable to perform an injection taking into account at least the data representing at least one previous injection location.

The at least one indicator element may alternatively or in addition be configured to signal to the user, during use, that the current location of theposition determination device100, as determined by theposition determination element110, is at a location where it is not acceptable or advisable to perform an injection taking into account at least the data representing at least one previous injection location.

In addition or as an alternative, the separateelectric device300 and/or the liquiddrug administration device200 may comprise at least indicator element performing the same function(s).

One or more of the at least one indicator elements may also be graphical elements as part of a graphical user interface displayed on a display.

The one or moreposition determination elements110 may e.g. comprise at least one gyroscope and/or at least one accelerometer to determine a location, e.g. in a relative way using fixed known/calibrated positions, as will be explained further in the following and as disclosed herein.

Alternatively, other types of position determination elements may be used e.g. including absolute measurement elements. In such embodiments, the one or moreposition determination elements110 may e.g. comprise a magnetometer or similar configured to derive the location in relation to a permanent or electromagnet source that is kept stationary at least during determination of the injection location. The location can thereby be derived by measuring a relative drop in signal strengths along three axes of the magnetometer or similar thereby given a distance and angle to the magnet source.

Alternatively, the one or moreposition determination elements110 may e.g. comprise a sound sensor for deriving a distance to a stationary (at least during determination of the injection location) sound emitting source by measuring a level of (e.g. ultra) sound. The distance in these embodiments may e.g. be derived by synchronizing clocks before the measurements or activating the sound source at fixed intervals and measuring the delay between the sound being emitted and being received thereby deriving a distance between the sound sensor and the stationary sound source. The stationary source (then not being sound emitting) may also comprise a material with predetermined reflective properties and measure the time for the signal to travel back and forth enabling deriving a distance between them.

Furthermore, the one or moreposition determination elements110 may e.g. comprise a light sensor, a reflector or similar, and light source similar to the sound sensor setup, but using visible, infrared, or ultraviolet light instead of sound waves as the property being measured. In such a setup, the light source, the reflector or similar, and the light sensor may be arranged at fixed positions in relation to each other where the light source pivots to allow emitting light at various angles in relation to the light sensor. By measuring the angle at which light is returned by the material of the reflector (having predetermined reflective properties), the distance can be derived e.g. using standard techniques for IR/UV distance measurements as readily known.

Additionally, the one or moreposition determination elements110 may e.g. comprise a radio signal source and sensor to derive the distance between the two e.g. by measuring the relative signal strength or by measuring the time for a signal to travel between the source and the sensor. In some embodiments, the respective source may e.g. be the separateelectric device300 or alternatively, the respective source may be separate from both the separateelectric device300 and theposition determination device100.

In some expedient embodiments, the stationary (at least during determination of the injection location) element may be located or integrated e.g. in the cap of the liquiddrug administration device200 thereby allowing the stationary element to readily be available at the time of injection. The stationary element (e.g. the cap) may e.g. simply be placed on a table or other during determination of injection location thereby providing a fixed reference point for use in determination of the injection location.

In some embodiments, the one or moreposition determination elements110 comprises a combination of the exemplary embodiments given above and as disclosed herein. This will add further reference point(s) and parameter(s) for determining the injection location thereby further increasing the quality and/or reliability thereof.

FIGS. 2a-2dschematically illustrate different views of one exemplary embodiment of a position determination device e.g. as illustrated inFIG. 1.

Shown inFIG. 2ais one exemplary embodiment of aposition determination device100 corresponding, in function at least, to embodiments already described in connection withFIG. 1 and as disclosed herein. This particular embodiment is of aposition determination device100 that is configured to be (releasably) attached or secured, during use, to a liquid drug administration device, e.g. like200 described in connection withFIG. 1 and elsewhere.

Theposition determination device100 may e.g. be configured to be secured to the liquid drug administration device using one or more suitable attachment elements or similar (not shown; see e.g.701 inFIGS. 8 and 9 for one example).

Alternatively, theposition determination device100 may be configured to be (releasably) secured to the liquiddrug administration device200 due to its particular shape, e.g. such as shown in this figure and explained further in the following in connection withFIGS. 3aand3b.

In this and corresponding embodiments, theposition determination device100 comprises one activation or operation button or similar201 and at least one indicator element (here three as an example)202,203,204 such as one or more lights, LEDs, etc., and/or one or more sound emitters used to signal the user of various indications, information, status, etc.

In the shown embodiment, theposition determination device100 comprises a confirmation light orLED202, a warning light orLED203, and a wireless communications connection light orLED204.

The confirmation light orLED202 may, as disclosed herein, indicate when a given position is ok for drug injection, while the warning light orLED203 may indicate when a given position is not ok. The connection light orLED204 may indicate when a wireless connection is established to a separate electric device (e.g. like300 inFIGS. 1 and 7) and/or a liquid drug administration device (e.g. like200 inFIGS. 1, 3, 8, and 9).

It should be noted, that the functions of two or more lights or LEDs could be done by fewer lights or LEDs, e.g. only a single one. As an example, one multi-colored light or LED could be e.g. green for confirmation and red for warning. In addition or as alternatives, the indications could also be audible e.g. using one or more sound emitters or the indications of whether a position is ok or not ok could be done by vibration or a set of different vibrations e.g. using one or more haptic elements.

The indications could also be given on a separate electric device (e.g. like300 inFIGS. 1 and 7) e.g. in an app or program running on a smartphone, tablet, laptop, PC, etc. and/or on a liquid drug administration device (e.g. like200 inFIGS. 1, 3, 8, and 9) instead or in duplication.

Also indicated inFIG. 2ais a proximal and a distal direction. The proximal direction is a direction generally towards the end of theposition determination device100 that normally would be closest to the injection element of a liquid drug administration device (see e.g.200 inFIGS. 1, 3a-3b,8, and9) that theposition determination device100 is secured to while the distal direction is parallel and opposite to the proximal direction.

It should be noted, that the orientation of theposition determination device100 when secured to the liquid drug administration device in certain embodiments may not be significant. The shown embodiment of theposition determination device100 could e.g. be rotated about its central axis on the liquid drug administration device and it could e.g. also be flipped or turned 180° (so the otherwise distal end of theposition determination device100 now would be in the proximal direction of the liquid drug administration device) while still working.

Shown inFIG. 2bis theposition determination device100 ofFIG. 2ashown from ‘above’, i.e. shown from a direction pointing towards the activation oroperation button201 and the

indicators

202,203, and204.

Shown inFIG. 2cis theposition determination device100 ofFIG. 2ashown from one side.

Shown inFIG. 2dis theposition determination device100 ofFIG. 2ashown from one end. As can be seen, theposition determination device100 in this view has a more or less circular ring shape with an opening or cut-out240 for receiving at least a part of the liquid drug administration device when being secured to this.

Theposition determination device100 may e.g. have a suitable ‘soft’ or flexible material on its inside on parts that are to be in contact with the liquid drug administration device when attached thereto and/or have pliable walls enabling it to ‘snap’ onto the liquid drug administration device200 (and to be released therefrom again).

FIG. 3aschematically illustrates a perspective view of the position determination device ofFIGS. 2a-2dbeing secured to a liquid drug administration device.

Shown is theposition determination device100 ofFIG. 2ain a state where it is attached or secured to a liquiddrug administration device200 that e.g. may be of the type mentioned in connection withFIG. 1, and in particular a liquid insulin administration device such as an insulin pen or similar.

The liquiddrug administration device200 may be of any suitable type and in this and corresponding embodiments of theposition determination device100 it does not require any modification of the liquid drug administration device to take advantage of the present invention. Moving and using the liquiddrug administration device200 will move theposition determination device100 with a fixed positional relationship between them. If theposition determination device100 is removed and attached back onto the liquiddrug administration device200 at another position there may in certain cases be a need for re-calibration, unless the position and/or orientation of theposition determination device100 on the liquiddrug administration device200 is known a priori as disclosed herein.

FIG. 3bschematically illustrates a perspective view of theposition determination device100 and the liquiddrug administration device200 ofFIG. 3abefore theposition determination device100 is secured to the liquiddrug administration device200.

In this and corresponding embodiments, theposition determination device100 is simply snapped or clicked onto the liquiddrug administration device200 as indicated by the four broken lines. The shape of theposition determination device100 being generally of a hollow cylindrical shape with its opening or cut-out—as also shown inFIGS. 2a-2d—enables theposition determination device100 to easily but securely be temporarily attached or fixed to the liquiddrug administration device200.

The specific shape of theposition determination device100 ofFIG. 3band corresponding devices are particularly well suited to be secured to pen-type liquid drug administration devices. But the shape may of course vary according to the liquid drug administration device that it is to be used together with.

Alternatively, theposition determination device100 may be ‘slided’ onto the liquiddrug administration device200 from one of the ends. As other alternatives, theposition determination device100 may comprise one or more attachment or securing elements enabling it to be secured to the liquiddrug administration device200 in other ways (whereby theposition determination device100 may have a different shape) e.g. as described in connection withFIGS. 8 and 9.

Embodiments corresponding to the one shown inFIGS. 2 and 3 can only fit with certain designs of liquid drug administration devices200 (although the shape and/or size may be changed). In order to accommodate a wider set of liquiddrug administration devices200 by a singleposition determination device100, some embodiments of aposition determination device100 involves a main or overall body or housing that comprises or is separable into (at least) two parts with one part being an interchangeable fitter component (also referred to as a separable and interchangeable part) that is adapted to receive, attach to, or connect with a specific liquiddrug administration device200 or specific set of similar (similar in the sense that the same fitter component can receive, attach to, or connect with) type(s) of liquiddrug administration devices200 and the other part is the main part of theposition determination device100 comprising the position determination element, the one or more processing units, and other functional elements as disclosed herein. The fitter component may e.g. be simple casing produced in a wide set of variations with the purpose of locking on to the specific drug administration device (or set or class) and providing a vehicle that the main part of theposition determination device100 attaches to by one or more securing elements, e.g. a set of groves, magnets, or other suitable fixation mechanisms. In this way, only the fitter component needs to be chosen or changed to accommodate another type of liquid drug administration device.

The liquiddrug administration device200 will typically comprise at least one activation button or other activation elements to initiate the actual administration of the liquid drug to the user.

In some embodiments, theposition determination device100 will derive data (or obtain and e.g. transmit a position signal) representing an actual injection location based on the user specifically activating the liquiddrug administration device200 to administer the liquid drug.

In this way, only one activation action from the user is needed even if theposition determination device100 and the liquiddrug administration device200 are separate devices.

If theposition determination device100 is integrated with the liquiddrug administration device200 this is of course relatively easily enabled.

Even if theposition determination device100 is not integrated with the liquiddrug administration device200 an alternative measure may e.g. be that pressing the activation button or the like on the liquiddrug administration device200 physically will activate the activation button of the position determination device at the same time. It may also be the other way around where activation of the activation button of the position determination device physically will activate an activation button or the like on the liquiddrug administration device200.

This could e.g. be achieved if theposition determination device100 is located on the liquiddrug administration device200 so that the position determination device's activation button is on top of (or in any other engaging relationship with) the activation button of thedrug administration device200. It is to be understood that the specific location of the various activation buttons may be different in specific implementations.

Alternatively, a pressure sensor may e.g. be connected to the activation button of the liquiddrug administration device200 to allow theposition determination device100 to register the position at the exact moment of the injection. This pressure sensor may be manual, mechanical or may be implemented using a remote distance measurement e.g. as described in the following. This distance measurement would be used to detect movement of the activation button of the liquiddrug administration device200.

According to some embodiments, the remote distance measurement may be performed e.g. by

- using an IR light source, light sensor and a reflector having a material with predetermined reflective properties. By measuring the angle at which light from the source is reflected on the material and returned to the sensor the distance can be derived,
- by placing a magnetic source at or near the activation button and a magnetic sensor at a known, static position. In this embodiment the distance is derived by measuring the strength of the magnetic signal and comparing to a baseline for the magnetic source, and/or
- by using other distance measuring techniques such as using a camera to e.g. measure the relative size of the activation button from a static position thereby deriving the distance.

A microphone or other sound sensor may also be used as another alternative to derive data representing an actual injection location based on the user specifically activating the liquiddrug administration device200 to administer the liquid drug for thosedrug administration devices200 that incorporates distinct sounds for increase, decrease, and release of the drug dosage. This is common e.g. among insulin administration devices to allow users with impaired sight to hear when the dosage is respectively increased, decreased, or released. An aspect of this and embodiments thereof are shown and explained further in connection withFIG. 10.

For liquiddrug administration devices200 that incorporate mechanical aspects to prime or set a dosage to be administered, aposition determination device100 comprising at least one accelerometer or other suitable movement detection element, the at least one accelerometer/movement detection element may according to some embodiments be used to capture the changes in dosage. An aspect of this and embodiments thereof are shown and explained further in connection withFIG. 11.

In some embodiments (including the ones explained in connection withFIGS. 1 to 2dand in the following), theposition determination device100 may further comprises an image sensor or other sensor element configured to detect an amount of liquid drug being administered by the liquiddrug administration device200. Alternatively, the amount of liquid drug being administered by the liquiddrug administration device200 may be determined as shown and described in connection withFIG. 10 and/orFIG. 11. In this way, dosage data may be collected (and communicated further on) by theposition determination device100 in situations where a liquiddrug administration device200 otherwise does not support this.

FIG. 4 schematically illustrates a flow chart of one embodiment of position determination by a position determination device e.g. as shown inFIGS. 1 to 3band8 to9 and embodiments thereof.

The method starts or initiates atstep401 and atstep402 the user activates the position determination device (e.g. a position determination device as disclosed herein such as one shown and explained in connection withFIGS. 1-3band8-9 and variations thereof or alternatively of another type) by pressing an appropriate activation element (e.g. like201 shown inFIGS. 2a-3b, and9).

Atstep403, the user moves the position determination device, or rather moves the liquid drug administration device (e.g. like200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9 or alternatively of another type) with the attached or integrated position determination device to a given pre-determined or pre-selected starting position. The starting position may e.g. be the navel, a knee, an elbow, or any other appropriate starting position as calibrated and may be used as the starting point of any location determination for the associated drug injection. The starting position may e.g. be selected by the user.

After a few seconds of non-movement (or by the user activating an appropriate activation element or some other action or means), the current position (being the starting position) is automatically registered and stored as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), and/or in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9).

For relevant embodiments, at least one indicator element, e.g. a confirmation light or LED like202 inFIGS. 2a-3band8-9, is activated until the position determination device100 (and the liquid drug administration device) is moved again.

Atstep404, the position determination device (and the liquid drug administration device) is moved to another location referred to as an anchor point or the like related to a desired injection location. An anchor point may e.g. be the left knee of the user if the desired injection location is at the left thigh, etc.

The anchor point location may e.g. be chosen by the user or suggested or recommended e.g. as described in connection withstep504 ofFIG. 5.

After a few seconds of non-movement (or by the user activating an appropriate activation element), the current position (being the anchor point) is automatically registered and stored as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9).

For relevant embodiments, the least one indicator element, e.g. the confirmation light or LED, is activated until the position determination device (and the liquid drug administration device) is moved again.

In some embodiments, the anchor point is not necessarily needed and step403 proceeds directly to step405. This depends on the used position determination scheme.

Atstep405, the position determination device (and the liquid drug administration device) is moved to a desired injection location. The desired injection location may e.g. be chosen by the user or suggested or recommended e.g. as described in connection withstep506 ofFIG. 5.

If the position of the desired injection location is determined to be too close to previous injection locations (e.g. within about 1 or about 3 cm as advised in the current state of the diabetes treatment art within a given time-frame) by the one or more processing units of the position determination device according to overall general or the user's specifically entered guidelines, then at least one indicator element, e.g. a warning light or LED like203 inFIGS. 2a-3band9, will activate prompting the user that current position is not suitable or recommended for injection and that another injection location should be chosen.

The position determination device (and the liquid drug administration device) should then be moved to a new injection location and when that is done and the new injection location is determined—by the one or more processing units like described above and elsewhere—to be suitable then least one indicator element, e.g. a confirmation light or LED like202 inFIGS. 2a-3b, is activated to signal that it is ok to perform an injection at the current injection location.

Atstep406, the user activates the liquid drug administration device to administer the liquid drug at the injection location and also presses or activates an appropriate activation element (e.g. like201 shown inFIGS. 2a-3band9) to register and store the position of the actual injection location as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9). As noted previously, it may alternatively be the activation of the liquid drug administration device that triggers the registration and storage of the actual injection location.

Accordingly, data representing the position of the actual injection location is stored in the device itself and/or, if possible, transmitted to a separate electric device (e.g.300 inFIGS. 1 and 7) and/or a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9) and stored there for later use and/or retrieval. After the transmission is completed, the position determination device may deactivate and the method ends atstep407. If transmission for some reason is not possible due to the receiving device being out of reach, being shut down, being in flight mode, or for other reasons, the device itself may deactivate as stated, and then transmit the stored data to the other device upon a subsequent activation and when possible.

Data representing a number of actual positions may in this way be collected, e.g. together with additional information, time-stamp, amount of administered liquid drug (for embodiments supporting that), etc. This provides a very comprehensive ‘diary’ for the user, which may be useful for a user in improving self-administration routines as well as for medical professionals e.g. to check for regimen compliance, gather data for research, improve patient education, etc.

Using both a starting point and an anchor point increases the precision of the registration of the injection location. However, in some alternative embodiments, an anchor point may be selected in some way (e.g. by the user choosing one or by being recommending one) and the injection location is determined relative only to the selected anchor point, i.e. a starting point is not used.

FIG. 5 schematically illustrates a flow chart of one embodiment of a method of suggesting an injection location.

The method starts or initiates atstep501 and at step502 (which may correspond to step402 inFIG. 4) the user activates the position determination device (e.g. a position determination device as disclosed herein such as one shown and explained in connection withFIGS. 1-3band8-9 and variations thereof or alternatively of another type) by pressing an appropriate activation element (e.g.201 shown inFIGS. 2a-3b, and9).

At step503 (which may correspond to step403 inFIG. 4), the user moves the position determination device and the liquid drug administration device (e.g. like200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9 or alternatively of another type) to a given pre-determined or pre-selected starting position, e.g. like the navel, a knee, an elbow, or any other appropriate starting position as calibrated.

After a few seconds of non-movement (or by some other action or means), the current position (being the starting position) is automatically registered and stored as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), and/or in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9). For relevant embodiments, at least one indicator element, e.g. a confirmation light or LED like202 inFIGS. 2a-3band9, is activated until the position determination device100 (and the liquid drug administration device) is moved again.

Atstep504, an appropriate injection location to use is derived.

The injection location to use this particular time may be derived by a separate electric device (e.g.300 inFIGS. 1 and 7). Alternatively, it may be derived by the one or more processing units of the position determination device or a liquid drug administration unit.

The inject location to use at this time is derived according to general or the user's specifically entered guidelines stored as data. This may for example be according to a scheme where the determination of injection sites e.g. follow a circular or spiral pattern across the belly to ensure an even spread of sites over a given period like a week, a linear upward moving of sites on the thighs alternating between the right and the left, or a time-based guideline always advising about the injection site unused for the longest amount of time to ensure the largest spread. The used guidelines should be chosen based on dialogue with medical professionals and individual preferences.

After the injection location to use next has been derived, an anchor point associated with the given next injection location is presented to the user, e.g. on a display of the position determination device, the separate electric device, or in another suitable way.

Atstep505, the user moves the liquid drug administration device (and thereby the position determination device) to the presented anchor point or the like of the suggest injection location. If the user moves the liquid drug administration device and the position determination device to a different location than the suggested position, a warning may e.g. displayed to the user (e.g. using at least one indicator element such as a warning light or LED like203 inFIGS. 2a-3b, and9) and/or on a separate electric device (e.g.300 inFIGS. 1 and 7).

After a few seconds of non-movement (or by some other action or means), the current position (being the anchor point) is automatically registered and stored as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), and/or in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9). For relevant embodiments, the least one indicator element, e.g. the confirmation light or LED, is activated until the position determination device (and the liquid drug administration device) is moved again.

In some embodiments, the anchor point is not necessarily needed and step503 proceeds directly to step506. This depends on the used position determination scheme

Atstep506, the injection location (as being associated with the registered anchor point) to use next as derived atstep504 is displayed e.g. on the display of the position determination device, the separate electric device, or in another suitable way.

Atstep507, the user moves the liquid drug administration device (and thereby the position determination device) to the presented suggested injection location.

For relevant embodiments, at least one indicator element, e.g. a warning light or LED like203 inFIGS. 2a-3b, and9, will activate and stay activated until the position determination device is moved within a predetermined threshold distance of the injection location that was displayed atstep506.

The predetermined threshold may be defined in the user's entered guidelines or be an overall general threshold.

For relevant embodiments, when the position determination device comes within the predetermined threshold distance of the injection location then least one indicator element, e.g. a confirmation light or LED like202 inFIGS. 2a-3b, is activated to signal that it is ok to perform an injection at the current injection location.

Atstep508, the user activates the liquid drug administration device to administer the liquid drug at the injection location and also presses or activates an appropriate activation element (e.g. like201 shown inFIGS. 2a-3b, and9) to register and store the position of the actual injection location as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), and/or in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9). As noted previously, it may alternatively be the activation of the liquid drug administration device that triggers the registration and storage of the actual injection location.

Accordingly, data representing the position of the actual injection location is stored in the device itself and/or, if possible, transmitted to a separate electric device (e.g.300 inFIGS. 1 and 7) and/or a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9) and stored there for later use and/or retrieval. After the transmission is completed, the position determination device may deactivate and the method ends atstep509. If transmission for some reason is not possible due to the receiving device being out of reach, being shut down, being in flight mode, or for other reasons, the device itself may deactivate as stated, and then transmit the stored data to the other device upon a subsequent activation and when possible.

FIG. 6 schematically illustrates a flow chart of one embodiment of a calibration method of a position determination device.

The method starts or initiates atstep601 and atstep602 the user activates the position determination device (e.g. a position determination device as disclosed herein such as one shown and explained in connection withFIGS. 1-3band8-9 and variations thereof or alternatively of another type) by pressing an appropriate activation element (e.g.201 shown inFIGS. 2a-3b, and9).

Atstep603, the user moves the position determination device, or rather moves the liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9) with the attached or integrated position determination device to a given pre-determined or pre-selected starting position and keeps the position determination device still. It may be that the user chooses the starting position him- or herself or that it is pre-defined and presented in some way, e.g. using a separate electric device (e.g.300 inFIGS. 1 and 7).

This starting position is intended to be used for the following position determinations (e.g. at least until a next (re-)calibration).

Atstep604, the user activates an appropriate activation element and the current position (being the starting position) is then registered and stored as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), and/or in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9).

At step,605 the user indicates a boundary of the injection area that is to be associated with the starting position (if there is one to be associated). In some embodiments, this may be done by the user moving the position determination device from the starting position to an edge of the injection area and then, while keeping the activation element active or pressed, the user traces the edge of the injection area with the position determination device (being attached or integrated with the liquid drug administration device). Alternatively, other ways to indicate the boundary and/or the injection area may be used.

The position determination device then registers and stores the injection area and/or boundary as data in its memory and/or storage and/or transmits the data to the separate electric device (e.g.300 inFIGS. 1 and 7) and/or a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9) for storage and/or visual feedback to the user.

Atstep606, the separate electric device displays or presents information to the user about which anchor position to register. Alternatively, the position determination device or a liquid drug administration unit displays or presents the information to the user.

Atstep607, the user moves the position determination device and the liquid drug administration device to the shown anchor position.

At step608, the current position (being the anchor point) is automatically registered and stored as data in the memory and/or storage of the position determination device, in the memory and/or storage of a separate electric device (e.g.300 inFIGS. 1 and 7), and/or in the memory and/or storage of a liquid drug administration device (e.g.200 shown and explained in connection withFIGS. 1, 3a-3b, and8-9) e.g. by keeping the position determination device still for a predetermined amount or time or by activating an appropriate activation element (e.g.201 shown inFIGS. 2a-3b, and9). For relevant embodiments, the least one indicator element, e.g. the confirmation light or LED, is activated after registration until the position determination device (and the liquid drug administration device) is moved again.

Atstep609, the user indicates the boundary of the injection area that is to be associated with the current anchor position and it is registered and stored in the same manner as atstep605 for the starting position.

Atstep610 it is checked whether this procedure is to be done for any further anchor points. If yes, the method loops back to step606 whereby steps606-610 is repeated in connection with the next anchor point. If no (signifying no remaining anchor points), the calibration process terminates atstep611.

In this way, simple and reliable calibration is provided.

It is noted, that the methods illustrated and described in connection withFIGS. 4, 5, and6 and embodiments and variations thereof each (individually or in any combination) may be used independently of the described aspects and embodiments of the position determination device as disclosed herein although they together work especially well.

FIG. 7 schematically illustrates a separate electric device displaying a ‘heatmap’ view or similar of earlier injections.

Shown is a separateelectric device300, e.g. corresponding to the one shown inFIGS. 1 and 7, having adisplay310 to be used according to some aspects in connection with some embodiments of a position determination device as disclosed herein (e.g. such as100 shown inFIGS. 1-3b,8-9, and variations thereof or of another type) and a liquid drug administration device (e.g. such as200 shown inFIGS. 1 and 3a-3b,8-9, and variations thereof or of another type).

As already mentioned, actual injections locations may preferably be registered on an ongoing basis using the position determination device and the liquid drug administration device.

According to these aspects, the actual injection locations may be shown as a graphical representation of data generally known as a ‘heat map’ or similar where the individual values (location e.g. together with further relevant information like time of injection, actual amount of injected liquid drug, etc.) are represented as colors in a color scheme superimposed on a picture or a graphic representation of the overall injection area(s), e.g. like the torso, the thighs, upper arms, or what other injection area the user has defined, etc. The values may e.g. be stored in a matrix data structure and/or any other suitable data structure.

The color scheme may e.g. be one from green to red where a given injection location is marked yellow if it was taken in (too) close proximity (e.g. within 1 or 3 cm, or as chosen by the user) to one another injection location made within a predetermined time (e.g. a week or other timeframe as e.g. determined by the user), and red if it is in (too) close proximity to 2 or more injection locations, and green in all other cases.

The heatmap may be updated from the device when activated thus enabling the user to check an intended injection location in relation to previous injection locations.

In a recommendation mode (e.g. as indicated inFIG. 5), the device itself may show status of injection locations based on the same color scheme or recommend locations based on the chosen rotation principles and e.g. assessment of possible lipohypertrophy by medical professionals thereby guiding the user to a suitable injection site. In some further embodiments, this involves showing injection history, areas to avoid because of lipohypertrophy, and/or areas to inject in.

The aspect(s) of showing previous injection locations like this may be used independently of the described aspects and embodiments of the position determination device as disclosed herein although they together work especially well.

FIG. 8 schematically illustrates an embodiment of a locking mechanism for attaching an embodiment of a position determination device to a drug administration device.

Shown is an embodiment of aposition determination device100 as disclosed herein being attached to a drug administration device, here in the form of an insulin pen or other pen type liquid drug administration device, as well as an enlargement illustrating further details.

In this and corresponding embodiments, theposition determination device100 as disclosed herein comprises one exemplary embodiment of an attachment element in the form of alocking mechanism701 configured to releasably engage with a mating orcorresponding locking mechanism801 of the liquiddrug administration device200. The showndrug administration device200 comprises acap210 and amain body211. More specifically, thelocking mechanism701 is configured to engage with alocking mechanism801 of themain body211 of thedrug administration device200 that normally is used to engage a locking mechanism of thecap210, i.e. thelocking mechanism701 of theposition determination device100 corresponds to the locking mechanism of the cap in that they will be the same or at least similar or compatible.

In some further embodiments, and as shown, thelocking mechanism701 is further configured to engage with thelocking mechanism702 of the cap210 (see e.g. also702 inFIG. 9) so that thecap210 still can be attached to thedrug administration device200 even with theposition determination device100 in place, now just connecting with theposition determination device100 instead of directly to thedrug administration device200.

Thelocking mechanism701 allows the user an easy way to attach/detach theposition determination device100 to/from thedrug administration device200 in a reliable way. The specific embodiment of such alocking mechanism701 will typically depend on the specific shape, size, and/or form of thecap210 of thedrug administration device200 and how this attaches to the main body of thedrug administration device200.

FIGS. 9aand 9bschematically illustrate an embodiment of the position determination device attached to a drug administration device and by itself.

Shown inFIG. 9ais illustrated an embodiment of theposition determination device100 attached to adrug administration device200 as disclosed herein, respectively, where thecap210 of thedrug administration device200 is also attached to themain body211 of thedrug administration device200. Thecap210 is shown transparently and with a cut-out to illustrate parts of themain body211 of thedrug administration device200. The attachment is done using alocking mechanism701 as disclosed herein. In some embodiments of thelocking mechanism701, and as shown, it further comprises anengaging element702 for allowing a locking mechanism of thecap210 to engage so that thecap210 may be attached to theposition determination device100 instead of to themain body211 of the liquid drug administration device200 (see e.g. alsoFIG. 8).

The shown liquiddrug administration device200 also comprises anactivation button201, as well as a number of indicator elements here in the form of a confirmation light orLED202, a warning light orLED203, and a wireless communications connection light orLED204 for user feedback as disclosed herein.

FIG. 10 schematically illustrates an exemplary sound signal emitted from a liquid drug administration device when incrementing and decrementing10 (as an example) drug dosage units, respectively.

The liquid drug administration device may e.g. be one as disclosed herein or alternatively of another type as long as it generates distinct sounds in connection with dosage increments and decrements. As mentioned, such distinct sounds are common among insulin administration devices and some other types of drug administration devices to allow users with impaired sight to hear when the dosage is respectively increased or decreased. Many devices also generate a different sound in connection with release or administration of the drug.

Shown is agraph1000 comprising an exemplary sound signal or profile1001 (forth only denoted sound profile) as obtained by a suitable sound sensor where the x axis indicates time and they axis indicates amplitude of thesound profile1001.

The graph illustrates the sound profile of the distinct “click-sounds” as emitted by a liquid drug injection device for 10 dosage increments followed by 10 dosage decrements.

The graph clearly shows 20 distinct spikes. Furthermore, each dosage increment and each dosage decrement clearly produces a

distinct spike

1002,1002′, respectively, in the obtained sound profile. The dosage increments spikes1002 are similar to each other and thedosage decrement spikes1002′ are similar to each. Furthermore, the dosage increments spikes1002 are different to thedosage decrement spikes1002′. This enables the spikes to be differentiated from each other (and from noise) and enabling identification of what type of dosage action (increment or decrement) was taken by the user. A dosage increment or decrements is typically associated with a predetermined change in dose/units of the drug.

In this way, it is possible to exactly and reliably derive the amount of drug that is administered by ‘counting’ the pulses of each type (by obtaining the sound profile by a sound sensor and analyzing the sound profile to identify the respective spikes).

For sound profiles of the type shown inFIG. 10, a determination of whether a spike is related to a dosage increment or a dosage decrement may simply (but still reliably) e.g. be done by locating amplitude values respectively above/below a predetermined max/min threshold, by determining on what side (above/below) of an amplitude baseline a particular spike is, or by any other suitable method. Spikes above or below a certain threshold from the baseline could be filtered out or ignored.

As mentioned, a further distinct sound (and thereby further distinct spike) may also be generated by drug release thereby enabling corresponding determination of exactly when the drug is released by analyzing the sound profile in a corresponding way.

Additionally, determined distance between spikes, determined number of spikes, determined shape of signal or parts thereof, etc. may e.g. be compared with anticipated/predetermined distance between spikes, anticipated/predetermined number of spikes, anticipated/predetermined shape of signal or parts thereof, etc. when determining whether a spike is related to a dosage increment, decrement, and/or release/administration.

As an example, a sound profile may e.g. be captured by an appropriate sound sensor and ‘translated’ into changes in and/or release/administration of dosage e.g. using digital or analogue signal processing techniques.

In some embodiments, two or more separate sound sensors is used to filter out background noise and enhance the signal available for processing as generally known.

The sound sensor(s) may e.g. be comprises by a position determination device (e.g. as disclosed herein or alternatively of another type), by a separate electric device (e.g. as disclosed herein or alternatively of another type), and/or a liquid drug administration device (e.g. as disclosed herein or alternatively of another type).

This particular aspect is generally independent of the described aspects and embodiments of the position determination device as disclosed herein (and other disclosed aspects) although they together work especially well.

FIG. 11 schematically illustrates an example of the vibrations emitted by a liquid drug administration device, as measured by an accelerometer or similar, when increasing the drug dosage by 7 (as an example) units.

The liquid drug administration device may e.g. be one as disclosed herein or alternatively of another type as long as it incorporate mechanical aspects to prime or set a dosage (increment and/or decrement) to be administered.

The accelerometer or similar may e.g. be comprised by the liquid drug administration device or alternatively it could be comprised by a position determination device as disclosed herein or another device in vibratory transferring contact (at least during use) with the liquid drug administration device.

Shown is agraph1100 comprising three

exemplary vibration signals

1101,1101′,1101″ as obtained by at least one (3D or three-axis) accelerometer or other suitable movement detection element where the x axis indicates time and the y axis indicates extent of acceleration force of the vibration signals1101,1101′,1101″. Each of the three vibrations signals is associated with a different axis (1100: x,1100′: y,1100″: z) of the accelerometer or movement detection element.

The

exemplary vibration signals

1101,1101′,1101″ have been obtained for a drug administration device that incorporates a spring mechanism for priming the dosage.

As clearly can be seen, sevenspikes1102 are present in each

vibration signal

1101,1101′,1101″—one for each of the exemplary seven drug dosage unit increases.

Each increase is associated with a signal (spike) along all three axes (thereby being present in all the three vibration signals). The strength or extent and profile of the signal may be different for other types of drug administration devices.

The vibration signals, once obtained, may ‘translated’ into changes in dosage using e.g. digital or analogue signal processing techniques, e.g. somewhat along the lines as explained in connection withFIG. 10 or any other suitable ‘spike detection’ method. Predetermined vibration profiles (e.g. for several different liquid drug administration devices) may also be stored and compared to the obtained vibration signals to derive the information.

In this way, at least one accelerometer or movement detection element may be used to reliably capture the changes in dosage using vibration signals.

Having three vibrations signals readily available to analyze and derive information from (where a spike is present at least to some extent in all the three at least sometimes; in some situation a spike may only be (significantly) present in one or two of the vibration signals) increases the reliability and thereby accuracy of registering setting of a specific dosage (increment and/or decrement) to be administered by the liquid drug administration device using vibration signals.

In some embodiments, a plurality of accelerometers or movement detection elements may be used to measure the vibrations as they travel through the drug administration device which can be used to further reduce any (background) noise.

To further increase precision and reliability of detecting dosage settings (and dosage delivery), a combination of both sound (e.g. as described in connection withFIG. 10) and acceleration/movement detection sensors may be used. In such embodiments, each sensor setup, could measures the drug dosage independently and may subsequently be combined into a single measurement for drug dosage.

Illustrated inFIG. 12ais cross section of aposition determination device100 and a liquiddrug administration device200 as generally disclosed herein. The liquiddrug administration device200 is a liquiddrug administration device200 of a first type, i.e. a first liquiddrug administration device200. Theposition determination device100 comprises a main body orhousing1201 and a first separable and interchangeable part1202 (also referred to herein as fitter or fitter component) being attached, in this particular and corresponding embodiments, to the main body orhousing1201 via a number (here two as an example) of securingelements1220. The first separable andinterchangeable part1202 also connects with (or otherwise accommodates) the first liquiddrug administration device200, in this particular example by receiving it (fully or partly). The main body orhousing1201 comprises the position determination element, the one or more processing units, and other functional elements as disclosed herein.

Illustrated inFIG. 12bis a cross section of aposition determination device100 with the same main body orhousing1201 as inFIG. 12abut now attached to a different separable andinterchangeable part1202′ (i.e. a second separable andinterchangeable part1202′) that connects with (or otherwise accommodates) a second liquiddrug administration device200′ being of different shape, type, etc. than the first liquiddrug administration device200.

As can be seen, this allows for changing between respective separable and interchangeable parts only in order to accommodate or connect theposition determination device100—or rather its main body orhousing1201—with different drug administration devices.

In some alternative embodiments, the main body orhousing1201 and the respective separable and

interchangeable part

1202,1202′, when joined or attached together, are configured to receive and/or accommodate a respective liquid

drug administration device

200,200′.

In some embodiments as disclosed herein, the position determination device further comprises a temperature sensor configured to continuously monitor whether the liquid drug is kept at safe temperature. A warning may be given before the temperature reaches levels that will make the liquid drug unfit for use. This warning may be given using audiovisual cues and/or by the separate electric device.

According to an alternate aspect of the invention, image recognition may be used as a method of locating injection sites. In some embodiments this may be achieved by using an image sensor that is e.g. hand held by the user or mounted on e.g. a pair of glasses or elsewhere on the user. The image produced by the image sensor would then e.g. be digitally processed to identify the liquiddrug administration device200, an injection region or location, and a location of the liquid drug administration device in relation to the injection region or location. This may be achieved by using any suitable image processing techniques such as but not limited to e.g. edge detection, ANN (artificial neural networks), DNN (deep neural networks), or some combination or derivation hereof.

In some embodiments image recognition may be used to augment or supplement the position determination techniques described herein. For example, the image recognition could add a second source of data to the movement or other based technique(s) as disclosed herein thus improving precision and/or reliability further. In other embodiments, image recognition could be used to determine actual starting points of the movement of hand and drug administration device thus reducing the need for fixed calibration.

Even though, the description mainly mentions user-administrated injection where a person to receive the liquid drug is also the user to administer the drug it is to be understood that at least for certain aspects, the user may e.g. be a medical professional or the like administering the liquid drug to another person.

Some of the different components are only disclosed in relation to a single embodiment of the invention, but is meant to be included in the other embodiments without further explanation.

Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims.

In the claims enumerating several features, some or all of these features may be embodied by one and the same element, component or item. The mere fact that certain measures are recited in mutually different dependent claims or described in different embodiments does not indicate that a combination of these measures cannot be used to advantage.

It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, elements, steps or components but does not preclude the presence or addition of one or more other features, elements, steps, components or groups thereof.