U.S. patent application number 15/481087 was filed with the patent office on 2018-10-11 for position determination device and system for determining and registering an injection location.
The applicant listed for this patent is Nordic Healthcare Advisory ApS. Invention is credited to David Tobias Boggild-Damkvist, Rasmus Tjalk-Boggild.
Application Number | 20180289901 15/481087 |
Document ID | / |
Family ID | 62067755 |
Filed Date | 2018-10-11 |
United States Patent
Application |
20180289901 |
Kind Code |
A1 |
Boggild-Damkvist; David Tobias ;
et al. |
October 11, 2018 |
POSITION DETERMINATION DEVICE AND SYSTEM FOR DETERMINING AND
REGISTERING AN INJECTION LOCATION
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).
Inventors: |
Boggild-Damkvist; David Tobias;
(Frederiksberg, DK) ; Tjalk-Boggild; Rasmus;
(Frederiksberg, DK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Nordic Healthcare Advisory ApS |
Frederiksberg |
|
DK |
|
|
Family ID: |
62067755 |
Appl. No.: |
15/481087 |
Filed: |
April 6, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/31568 20130101;
A61M 2205/3317 20130101; A61M 2205/3584 20130101; A61M 2205/13
20130101; A61M 2205/581 20130101; A61M 2205/3327 20130101; A61M
2205/3375 20130101; A61M 2205/52 20130101; A61M 2205/584 20130101;
A61M 2205/59 20130101; A61M 2205/3306 20130101; A61M 2205/50
20130101; A61M 2205/43 20130101; A61M 5/427 20130101; A61M 5/20
20130101; A61M 2205/583 20130101; A61M 2205/70 20130101; A61M
5/31525 20130101; A61M 2205/35 20130101; A61M 2205/502 20130101;
A61M 5/3202 20130101 |
International
Class: |
A61M 5/42 20060101
A61M005/42 |
Claims
1. A position determination device for determining and registering
an injection location of a liquid drug administered on a body part
of a user, wherein 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.
2. The position determination device according to claim 1, wherein
the one or more processing units 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.
3. The position determination device according to claim 1, wherein
the position determination device is further configured to be
secured to a liquid drug administration device.
4. The position determination device according to claim 3, wherein
the position determination device has a generally hollow
cylindrical shape with an opening or cut-out configured to receive
at least a part of the liquid drug administration device when being
secured to this.
5. The position determination device according to claim 3, wherein
the position determination device comprises a locking or attachment
mechanism configured to releasably engage with a mating or
corresponding locking or attachment mechanism of the liquid drug
administration device thereby attaching the position determination
device at a predetermined location on and/or predetermined
orientation in relation to the liquid drug administration
device.
6. The position determination device according to claim 5, wherein
the locking or attachment mechanism corresponds to a locking or
attachment mechanism of a cap of the liquid drug administration
device.
7. The position determination device according to claim 5, wherein
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.
8. The position determination device according to claim 1, wherein
the position determination device comprises a main body or housing
and a first separable and interchangeable part, 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 accommodate a different liquid drug
administration device, where 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, or 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.
9. The position determination device according to claim 1, wherein
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.
10. The position determination device according to claim 2, wherein
the position determination device is 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 an actual action of the user
activating the liquid drug administration device to administer the
liquid drug.
11. The position determination device according to claim 1, wherein
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.
12. The position determination device according to claim 9, wherein
the position determination device further comprises a sound sensor
configured to register one or more distinct sounds caused by the
liquid 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, and/or a vibration sensor 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.
13. The position determination device according to claim 1, wherein
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.
14. The position determination device according to claim 1, wherein
the position determination element comprises at least one gyroscope
and/or at least one accelerometer configured to provide the
position signal representing a current location of the position
determination device.
15. The position determination device according to claim 1, wherein
the position determination element comprises at least one
magnetometer or magnetism measuring element configured to provide
the position signal representing a current location of the position
determination device by measuring a relative drop in signal
strengths along respective axes of the magnetometer or magnetism
measuring element in relation to a permanent or electromagnet
source that is kept stationary at least during determination of the
injection location, at least one sound transceiver configured to
provide the position signal representing a current location of the
position determination device by emitting a predetermined sound
signal that is reflected by a sound reflecting source, that is kept
stationary at least during determination of the injection location,
and measuring a period of time from emitting the predetermined
sound signal until the reflected signal is received by the at least
one sound transceiver, at least one sound sensor configured to
provide the position signal representing a current location of the
position determination device by measuring a sound level of a
predetermined sound signal emitted by a sound emitting source that
is kept stationary at least during determination of the injection
location, at least one light sensor configured to provide the
position signal representing a current location of the position
determination device by measuring an angle of a predetermined light
signal being emitting by a light source and reflected by a
reflector having a material with predetermined reflective
properties, the light source being configured to pivot in different
directions, where the at least one light sensor, the light source,
and the reflector are kept stationary at least during determination
of the injection location, and/or at least one radio signal sensor
configured to provide the position signal representing a current
location of the position determination device by measuring a signal
strength of a predetermined radio signal emitted by a radio signal
source, that is kept stationary at least during determination of
the injection location, or by measuring a period of time from
emitting a predetermined radio signal by a radio signal source,
that is kept stationary at least during determination of the
injection location, until the emitted radio signal is received by
the at least one radio signal sensor.
16. The position determination device according to claim 15,
wherein 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.
17. The position determination device according to claim 1, wherein
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.
18. The position determination device according to claim 1, wherein
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.
19. The position determination device according to claim 1, wherein
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 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.
20. The position determination device according to claim 1, wherein
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.
21. The position determination device according to claim 20,
wherein 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 taking into account data
representing one or more previously registered actual injection
locations.
22. The position determination device according to claim 1, wherein
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.
23. The position determination device according to claim 1, wherein
the liquid drug is one selected from the group consisting of:
insulin, a drug for multiple sclerosis therapy with interferons and
immune suppressives, 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.
24. The position determination device according to claim 1, wherein
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.
25. The position determination device according to claim 1, wherein
the position determination device is for determining and
registering an injection location of self-administered liquid drug
administration on a user, or 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.
26. 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.
27. The position determination system according to 26, wherein 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.
28. Use of the position determination device according to claim 1
to register one or more locations of actual injection
locations.
29. Use of the position determination system according to claim 26,
to register one or more locations of actual injection locations.
Description
FIELD OF THE INVENTION
[0001] 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
[0002] 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.
[0003] 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.
[0004] 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.).
[0005] 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.
[0006] 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/abstra-
ct). 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.
[0007] 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.
[0008] A typical example of patient education material is found
e.g. at:
http://www.cc.nih.gov/ccc/patient_education/pepubs/subq.pdf
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] There is therefore a need for improved injection location
handling and/or management.
[0016] It would also be a benefit to provide precise data about
actual injection location(s).
SUMMARY OF INVENTION
[0017] It is an object to alleviate at least one or more of the
above mentioned drawbacks at least to an extent.
[0018] Furthermore, it is an object to provide improved injection
location handling and/or management.
[0019] Additionally, it is an object to enable precise data
relating to actual injection location(s).
[0020] A first aspect of the invention is defined in claim 1.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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).
[0028] In some embodiments, the position determination device
comprises a locking or attachment mechanism configured to
releasably engage with a mating or corresponding locking or
attachment mechanism of a liquid drug administration device (i.e.
the locking or attachment mechanism of the position determination
device is compatible with the locking or attachment mechanism of
the liquid drug administration device), thereby attaching the
position determination device at a predetermined location on the
liquid drug administration device and/or a predetermined
orientation in relation to the drug administration device. It is
facilitated by such a locking or attachment mechanism that a
distance from the position determination device to the needle (or
another point of reference) of the drug administration device is
known a priori. This avoids the need (or at least reduces it) for
re-calibration every time the position determination device is
attached to the drug administration device and may also increase
the accuracy of the injection location determination. In some
further embodiments, the locking or attachment mechanism of the
position determination device corresponds to a locking or
attachment mechanism of a cap of the liquid drug administration
device. In this way, the position determination device may be
attached or secured to the liquid drug administration device
instead of the cap liquid drug administration device (using the
existing locking or attachment mechanism of the liquid drug
administration device normally otherwise used for attaching its
cap). Additionally, the position determination device is attached
or secured to the liquid drug administration device at an a priori
known location.
[0029] 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.
[0030] 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.
[0031] 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.).
[0032] 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] In some embodiments, the position determination device
further comprises [0037] a memory and/or storage comprising data
representing at least one previous injection location, [0038] at
least one indicator element, configured to signal to the user
[0039] 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 [0040] 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.
[0041] 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.
[0042] 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.
[0043] 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.
[0044] 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.
[0045] In some embodiments, the position determination element
comprises one or more elements adding further reference point(s)
and parameter(s) for determining the injection location. In some
such embodiments, the position determination element comprises at
least one magnetometer or magnetism measuring element configured to
provide the position signal representing a current location of the
position determination device by measuring a relative drop in
signal strengths along respective axes of the magnetometer or
magnetism measuring element in relation to a permanent or
electromagnet source that is kept stationary at least during
determination of the injection location. In some other such
embodiments, the position determination element comprises at least
one sound transceiver configured to provide the position signal
representing a current location of the position determination
device by emitting a predetermined sound signal that is reflected
by a sound reflecting source, that is kept stationary at least
during determination of the injection location, and measuring a
period of time from emitting the predetermined sound signal until
the reflected signal is received by the at least one sound
transceiver. In some further such embodiments, the position
determination element comprises at least one sound sensor
configured to provide the position signal representing a current
location of the position determination device by measuring a sound
level of a predetermined sound signal emitted by a sound emitting
source that is kept stationary at least during determination of the
injection location. In some yet other such embodiments, the
position determination element comprises at least one light sensor
configured to provide the position signal representing a current
location of the position determination device by measuring an angle
of a predetermined light signal being emitting by a light source
and reflected by a reflector having a material with predetermined
reflective properties, the light source being configured to pivot
in different directions, where the at least one light sensor, the
light source, and the reflector are kept stationary at least during
determination of the injection location. In some yet further such
embodiments, the position determination element comprises at least
one radio signal sensor configured to provide the position signal
representing a current location of the position determination
device by measuring a signal strength of a predetermined radio
signal emitted by a radio signal source, that is kept stationary at
least during determination of the injection location, or by
measuring a period of time from emitting a predetermined radio
signal by a radio signal source, that is kept stationary at least
during determination of the injection location, until the emitted
radio signal is received by the at least one radio signal
sensor.
[0046] 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.
[0047] 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.
[0048] 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.
[0049] 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.
[0050] 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.
[0051] In some embodiments, the position determination device is
further configured to [0052] register a starting position in
response to the user moving the position determination device to a
pre-determined starting position, [0053] 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, [0054] 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.
[0055] In some embodiments, the position determination device is
further configured to [0056] 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.
[0057] In some embodiments, the position determination device is
further configured to [0058] register a starting position when the
user has moved the position determination device to a starting
position, [0059] if used, register a region in connection with the
starting position defining a region suitable for receiving
injections, [0060] 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.
[0061] 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.
[0062] 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.
[0063] In some embodiments, the position determination device is
for determining and registering an injection location of
self-administered liquid drug administration on a user.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] Another aspect of the present invention is a use of a
position determination device as disclosed herein and/or according
to any one of claims 1-25 (and combinations thereof) or the
position determination system as disclosed herein and/or according
to claim 26 and/or 27 to register one or more locations of actual
injection locations.
[0070] 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.
[0071] 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.
[0072] 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
[0073] All headings and sub-headings are used herein for
convenience only and should not be constructed as limiting the
invention in any way.
[0074] 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.
[0075] 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
[0076] FIG. 1 illustrates a schematic block diagram of embodiments
of a position determination device;
[0077] FIGS. 2a-2d schematically illustrate different views of one
exemplary embodiment of a position determination device e.g. as
illustrated in FIG. 1;
[0078] FIG. 3a schematically illustrates a perspective view of the
position determination device of FIGS. 2a-2d being secured to a
liquid drug administration device;
[0079] FIG. 3b schematically illustrates a perspective view of the
position determination device and the liquid drug administration
device of FIG. 3a before the position determination device is
secured to the liquid drug administration device;
[0080] FIG. 4 schematically illustrates a flow chart of one
embodiment of position determination by a position determination
device e.g. as shown in FIGS. 1 to 3b and 8 to 9 and embodiments
thereof;
[0081] FIG. 5 schematically illustrates a flow chart of one
embodiment of a method of suggesting an injection location;
[0082] FIG. 6 schematically illustrates a flow chart of one
embodiment of a calibration method of a position determination
device, e.g. as shown in FIGS. 1 to 3b;
[0083] FIG. 7 schematically illustrates a separate electric device
displaying a `heatmap` view or similar of earlier injections;
[0084] FIG. 8 schematically illustrates an embodiment of a locking
mechanism for attaching an embodiment of a position determination
device to a drug administration device;
[0085] FIGS. 9a and 9b schematically illustrate an embodiment of
the position determination device attached to a drug administration
device and by itself;
[0086] FIG. 10 schematically illustrates an exemplary sound signal
emitted from a liquid drug administration device when incrementing
and decrementing 10 drug dosage units, respectively;
[0087] 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
[0088] FIGS. 12a and 12b schematically 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
[0089] 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.
[0090] 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.
[0091] 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. in FIGS. 2a
and 3a-3b, whereas the term "distal direction" is meant to refer to
a direction parallel and opposite to the proximal direction.
[0092] FIG. 1 illustrates a schematic block diagram of embodiments
of a position determination device.
[0093] Shown is one embodiment of a position determination device
100 and a liquid drug administration device 200. The position
determination device 100 may e.g. be integrated with the liquid
drug administration device 200 or alternatively be (releasably)
attached or secured to the liquid drug administration device 200,
e.g. as shown and explained further in connection with FIGS. 3a-3b
and 8-9 or alternatively of another type.
[0094] The liquid drug administration device 200 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 200 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.
[0095] The position determination device 100 comprises one or more
position determination elements 110 and in this particular and
other embodiments, one or more processing units 150, at least one
digital memory and/or storage 160, and at least one communications
unit 120, preferably one or more standardized wireless
communications units e.g. like Wi-Fi, Bluetooth, NFC, etc.
communications units.
[0096] If the position determination device 100 is integrated with
the liquid drug administration device 200 they may share one or
more elements, such as the processing unit(s), the digital
memory/storage, and/or the communication unit(s).
[0097] Further shown is a separate electric device 300 comprising
its own one or more processing units 150', at least one digital
memory and/or storage 160', at least one communications unit 120',
and optionally a display 310.
[0098] Preferably, the position determination device 100 (and/or
the liquid drug administration device 200) may wirelessly
communicate or exchange data and information with the separate
electric device 300.
[0099] The separate electric device 300 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.
[0100] The position determination device 100 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.
[0101] According to an aspect of the present invention, the
position determination element 110 is configured to provide, during
use, a position signal representing a current location of the
position determination device 100 and the one or more processing
units 150 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 the position
determination unit 110. Alternatively (or in addition), the
position determination device 100 is configured to transmit, via
the communications unit 120, the position signal representing
directly or indirectly the current location to the separate
electric device 300, the liquid drug administration device 200,
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.
[0102] According to a further aspect of the present invention, the
position determination device 100 may be attached or secured and
(releasably) locked in relation to the drug administration device
200 with the use of a locking mechanism according to various
embodiments (see e.g. 701 in FIGS. 8 and 9 for one embodiment) at a
predetermined location on and/or predetermined orientation in
relation to the drug administration device 200. In this way, it is
ensured by such a locking mechanism that a distance from the
position determination device 100 to the needle of the drug
administration device 200 is always known a priori. This avoids (or
at least reduces) the need for re-calibration every time the
position determination device 100 is attached to the drug
administration device 200.
[0103] In some further embodiments, the position determination
device 100 attaches to the drug administration device 200 like a
cap of the drug administration device 200 normally would when the
position determination device 100 is not present, i.e. the locking
mechanism of the position determination device 100 corresponds to
the locking mechanism of the cap in that they will be the same or
at least similar or compatible. This ensures that the position
determination device 100 can be attached or secured to the drug
administration device 100 in a reliable way, since the locking
mechanism position determination device 100 is a `copy` of or at
least being corresponding to the locking mechanism of the cap.
[0104] In some further embodiments, the position determination
device 100 is further configured to allow the cap of the drug
administration device 200 to be attached to the position
determination device 100 rather than directly to the drug
administration device 200 itself when the position determination
device 100 is attached or secured to the drug administration device
200 (see e.g. 702 in FIGS. 8 and 9). This ensures that the cap may
still be attached thereby protecting the relevant parts of the drug
administration device 200 in a usual way.
[0105] The actual injection location may e.g. be calculated in the
following manner: From a known or predetermined starting position,
the position determination element 110 is reset to represent a
zero-length movement vector. As the position determination device
100 is moved, the position determination element 110 update its
internal representation of the distance moved to produce a 3D
movement vector. When the position determination device 100 is
moved to an anchor point, this movement vector is compared to the
calibrated vectors to determine which anchor point the position
determination device 100 is at. In addition, data from the position
determination element 110 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
with FIG. 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 element 100 (and e.g. the liquid drug administration
device 200 as attached or integrated) is moved by the user to a
final injection site.
[0106] 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.
[0107] Depending on specific circumstances, the location signal or
signals as obtained by the one or more position determination
elements 110 may comprise a certain amount of (background) noise.
In some embodiments, the position determination device 100
comprises elements to at least reduce or mitigate such noise.
According to some such embodiments, the one or more position
determination elements 110 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 the position determination device 100 is stationary or in
movement (e.g. in relation to a background measurement of standard
gravity g).
[0108] For portions of the obtained signal that is determined to
reflect a movement of the position determination device 100, 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.
[0109] In some embodiments, the position determination device 100
may automatically transmit, using the wireless communications unit
120, 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 elements 110)
to the separate electric device 300 and/or the liquid drug
administration device 200. 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, the position
determination device 100 may automatically transmit, using the
wireless communications unit 120, a signal representing the actual
injection location or a signal representing current location or
subsequent current locations as obtained by the one or more
position determination elements 110 to the separate electric device
300 and/or the liquid drug administration device 200. In this way,
the separate electric device 300 and/or the liquid drug
administration device 200 can derive the data representing an
actual injection location.
[0110] In some embodiments, the data representing an actual
injection location is derived in response to the user administering
the liquid drug using the liquid drug administration device 200.
This may in some embodiments be an actual action of the user
actually activating the liquid drug administration device 200 to
administer the liquid drug that triggers deriving the data
representing an actual injection location.
[0111] In some embodiments, the position determination device 100
may also comprise at least one indicator element (see e.g. 202,
203, and 204 in FIGS. 2a-3b and 9).
[0112] 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 the position determination device 100,
as determined by the position determination element 110, 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.
[0113] 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 the position determination device 100, as
determined by the position determination element 110, 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.
[0114] In addition or as an alternative, the separate electric
device 300 and/or the liquid drug administration device 200 may
comprise at least indicator element performing the same
function(s).
[0115] 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.
[0116] The one or more position determination elements 110 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.
[0117] Alternatively, other types of position determination
elements may be used e.g. including absolute measurement elements.
In such embodiments, the one or more position determination
elements 110 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.
[0118] Alternatively, the one or more position determination
elements 110 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.
[0119] Furthermore, the one or more position determination elements
110 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.
[0120] Additionally, the one or more position determination
elements 110 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 separate electric device 300 or
alternatively, the respective source may be separate from both the
separate electric device 300 and the position determination device
100.
[0121] 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 liquid drug
administration device 200 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.
[0122] In some embodiments, the one or more position determination
elements 110 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.
[0123] FIGS. 2a-2d schematically illustrate different views of one
exemplary embodiment of a position determination device e.g. as
illustrated in FIG. 1.
[0124] Shown in FIG. 2a is one exemplary embodiment of a position
determination device 100 corresponding, in function at least, to
embodiments already described in connection with FIG. 1 and as
disclosed herein. This particular embodiment is of a position
determination device 100 that is configured to be (releasably)
attached or secured, during use, to a liquid drug administration
device, e.g. like 200 described in connection with FIG. 1 and
elsewhere.
[0125] The position determination device 100 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 in FIGS. 8 and 9 for one example).
[0126] Alternatively, the position determination device 100 may be
configured to be (releasably) secured to the liquid drug
administration device 200 due to its particular shape, e.g. such as
shown in this figure and explained further in the following in
connection with FIGS. 3a and 3b.
[0127] In this and corresponding embodiments, the position
determination device 100 comprises one activation or operation
button or similar 201 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.
[0128] In the shown embodiment, the position determination device
100 comprises a confirmation light or LED 202, a warning light or
LED 203, and a wireless communications connection light or LED
204.
[0129] The confirmation light or LED 202 may, as disclosed herein,
indicate when a given position is ok for drug injection, while the
warning light or LED 203 may indicate when a given position is not
ok. The connection light or LED 204 may indicate when a wireless
connection is established to a separate electric device (e.g. like
300 in FIGS. 1 and 7) and/or a liquid drug administration device
(e.g. like 200 in FIGS. 1, 3, 8, and 9).
[0130] 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.
[0131] The indications could also be given on a separate electric
device (e.g. like 300 in FIGS. 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. like 200 in FIGS. 1, 3, 8,
and 9) instead or in duplication.
[0132] Also indicated in FIG. 2a is a proximal and a distal
direction. The proximal direction is a direction generally towards
the end of the position determination device 100 that normally
would be closest to the injection element of a liquid drug
administration device (see e.g. 200 in FIGS. 1, 3a-3b, 8, and 9)
that the position determination device 100 is secured to while the
distal direction is parallel and opposite to the proximal
direction.
[0133] It should be noted, that the orientation of the position
determination device 100 when secured to the liquid drug
administration device in certain embodiments may not be
significant. The shown embodiment of the position determination
device 100 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.degree. (so the otherwise distal end of the position
determination device 100 now would be in the proximal direction of
the liquid drug administration device) while still working.
[0134] Shown in FIG. 2b is the position determination device 100 of
FIG. 2a shown from `above`, i.e. shown from a direction pointing
towards the activation or operation button 201 and the indicators
202, 203, and 204.
[0135] Shown in FIG. 2c is the position determination device 100 of
FIG. 2a shown from one side.
[0136] Shown in FIG. 2d is the position determination device 100 of
FIG. 2a shown from one end. As can be seen, the position
determination device 100 in this view has a more or less circular
ring shape with an opening or cut-out 240 for receiving at least a
part of the liquid drug administration device when being secured to
this.
[0137] The position determination device 100 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 device 200 (and to be
released therefrom again).
[0138] FIG. 3a schematically illustrates a perspective view of the
position determination device of FIGS. 2a-2d being secured to a
liquid drug administration device.
[0139] Shown is the position determination device 100 of FIG. 2a in
a state where it is attached or secured to a liquid drug
administration device 200 that e.g. may be of the type mentioned in
connection with FIG. 1, and in particular a liquid insulin
administration device such as an insulin pen or similar.
[0140] The liquid drug administration device 200 may be of any
suitable type and in this and corresponding embodiments of the
position determination device 100 it does not require any
modification of the liquid drug administration device to take
advantage of the present invention. Moving and using the liquid
drug administration device 200 will move the position determination
device 100 with a fixed positional relationship between them. If
the position determination device 100 is removed and attached back
onto the liquid drug administration device 200 at another position
there may in certain cases be a need for re-calibration, unless the
position and/or orientation of the position determination device
100 on the liquid drug administration device 200 is known a priori
as disclosed herein.
[0141] FIG. 3b schematically illustrates a perspective view of the
position determination device 100 and the liquid drug
administration device 200 of FIG. 3a before the position
determination device 100 is secured to the liquid drug
administration device 200.
[0142] In this and corresponding embodiments, the position
determination device 100 is simply snapped or clicked onto the
liquid drug administration device 200 as indicated by the four
broken lines. The shape of the position determination device 100
being generally of a hollow cylindrical shape with its opening or
cut-out--as also shown in FIGS. 2a-2d--enables the position
determination device 100 to easily but securely be temporarily
attached or fixed to the liquid drug administration device 200.
[0143] The specific shape of the position determination device 100
of FIG. 3b and 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.
[0144] Alternatively, the position determination device 100 may be
`slided` onto the liquid drug administration device 200 from one of
the ends. As other alternatives, the position determination device
100 may comprise one or more attachment or securing elements
enabling it to be secured to the liquid drug administration device
200 in other ways (whereby the position determination device 100
may have a different shape) e.g. as described in connection with
FIGS. 8 and 9.
[0145] Embodiments corresponding to the one shown in FIGS. 2 and 3
can only fit with certain designs of liquid drug administration
devices 200 (although the shape and/or size may be changed). In
order to accommodate a wider set of liquid drug administration
devices 200 by a single position determination device 100, some
embodiments of a position determination device 100 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 liquid drug administration device 200 or specific set of
similar (similar in the sense that the same fitter component can
receive, attach to, or connect with) type(s) of liquid drug
administration devices 200 and the other part is the main part of
the position determination device 100 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 the
position determination device 100 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.
[0146] The liquid drug administration device 200 will typically
comprise at least one activation button or other activation
elements to initiate the actual administration of the liquid drug
to the user.
[0147] In some embodiments, the position determination device 100
will derive data (or obtain and e.g. transmit a position signal)
representing an actual injection location based on the user
specifically activating the liquid drug administration device 200
to administer the liquid drug.
[0148] In this way, only one activation action from the user is
needed even if the position determination device 100 and the liquid
drug administration device 200 are separate devices.
[0149] If the position determination device 100 is integrated with
the liquid drug administration device 200 this is of course
relatively easily enabled.
[0150] Even if the position determination device 100 is not
integrated with the liquid drug administration device 200 an
alternative measure may e.g. be that pressing the activation button
or the like on the liquid drug administration device 200 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 liquid drug administration device 200.
[0151] This could e.g. be achieved if the position determination
device 100 is located on the liquid drug administration device 200
so that the position determination device's activation button is on
top of (or in any other engaging relationship with) the activation
button of the drug administration device 200. It is to be
understood that the specific location of the various activation
buttons may be different in specific implementations.
[0152] Alternatively, a pressure sensor may e.g. be connected to
the activation button of the liquid drug administration device 200
to allow the position determination device 100 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 liquid drug administration device 200.
[0153] According to some embodiments, the remote distance
measurement may be performed e.g. by [0154] 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, [0155] 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
[0156] 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.
[0157] 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 liquid drug
administration device 200 to administer the liquid drug for those
drug administration devices 200 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
with FIG. 10.
[0158] For liquid drug administration devices 200 that incorporate
mechanical aspects to prime or set a dosage to be administered, a
position determination device 100 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 with FIG. 11.
[0159] In some embodiments (including the ones explained in
connection with FIGS. 1 to 2d and in the following), the position
determination device 100 may 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 200.
Alternatively, the amount of liquid drug being administered by the
liquid drug administration device 200 may be determined as shown
and described in connection with FIG. 10 and/or FIG. 11. In this
way, dosage data may be collected (and communicated further on) by
the position determination device 100 in situations where a liquid
drug administration device 200 otherwise does not support this.
[0160] FIG. 4 schematically illustrates a flow chart of one
embodiment of position determination by a position determination
device e.g. as shown in FIGS. 1 to 3b and 8 to 9 and embodiments
thereof.
[0161] The method starts or initiates at step 401 and at step 402
the user activates the position determination device (e.g. a
position determination device as disclosed herein such as one shown
and explained in connection with FIGS. 1-3b and 8-9 and variations
thereof or alternatively of another type) by pressing an
appropriate activation element (e.g. like 201 shown in FIGS. 2a-3b,
and 9).
[0162] At step 403, the user moves the position determination
device, or rather moves the liquid drug administration device (e.g.
like 200 shown and explained in connection with FIGS. 1, 3a-3b, and
8-9 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.
[0163] 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 in FIGS. 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 with FIGS. 1,
3a-3b, and 8-9).
[0164] For relevant embodiments, at least one indicator element,
e.g. a confirmation light or LED like 202 in FIGS. 2a-3b and 8-9,
is activated until the position determination device 100 (and the
liquid drug administration device) is moved again.
[0165] At step 404, 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.
[0166] The anchor point location may e.g. be chosen by the user or
suggested or recommended e.g. as described in connection with step
504 of FIG. 5.
[0167] 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 in FIGS. 1 and 7), in the memory and/or storage of a
liquid drug administration device (e.g. 200 shown and explained in
connection with FIGS. 1, 3a-3b, and 8-9).
[0168] 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.
[0169] In some embodiments, the anchor point is not necessarily
needed and step 403 proceeds directly to step 405. This depends on
the used position determination scheme.
[0170] At step 405, 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
with step 506 of FIG. 5.
[0171] 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 like 203 in FIGS. 2a-3b and 9, will activate prompting
the user that current position is not suitable or recommended for
injection and that another injection location should be chosen.
[0172] 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 like 202 in FIGS. 2a-3b,
is activated to signal that it is ok to perform an injection at the
current injection location.
[0173] At step 406, 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. like 201 shown in FIGS. 2a-3b and 9) 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 in FIGS. 1 and 7), in the memory and/or storage of a
liquid drug administration device (e.g. 200 shown and explained in
connection with FIGS. 1, 3a-3b, and 8-9). 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.
[0174] 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 in
FIGS. 1 and 7) and/or a liquid drug administration device (e.g. 200
shown and explained in connection with FIGS. 1, 3a-3b, and 8-9) and
stored there for later use and/or retrieval. After the transmission
is completed, the position determination device may deactivate and
the method ends at step 407. 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.
[0175] 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.
[0176] 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.
[0177] FIG. 5 schematically illustrates a flow chart of one
embodiment of a method of suggesting an injection location.
[0178] The method starts or initiates at step 501 and at step 502
(which may correspond to step 402 in FIG. 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
with FIGS. 1-3b and 8-9 and variations thereof or alternatively of
another type) by pressing an appropriate activation element (e.g.
201 shown in FIGS. 2a-3b, and 9).
[0179] At step 503 (which may correspond to step 403 in FIG. 4),
the user moves the position determination device and the liquid
drug administration device (e.g. like 200 shown and explained in
connection with FIGS. 1, 3a-3b, and 8-9 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.
[0180] 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 in FIGS. 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 with FIGS. 1,
3a-3b, and 8-9). For relevant embodiments, at least one indicator
element, e.g. a confirmation light or LED like 202 in FIGS. 2a-3b
and 9, is activated until the position determination device 100
(and the liquid drug administration device) is moved again.
[0181] At step 504, an appropriate injection location to use is
derived.
[0182] The injection location to use this particular time may be
derived by a separate electric device (e.g. 300 in FIGS. 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.
[0183] 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.
[0184] 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.
[0185] At step 505, 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 like 203 in FIGS. 2a-3b, and 9) and/or on a separate
electric device (e.g. 300 in FIGS. 1 and 7).
[0186] 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 in FIGS. 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 with FIGS. 1,
3a-3b, and 8-9). 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.
[0187] In some embodiments, the anchor point is not necessarily
needed and step 503 proceeds directly to step 506. This depends on
the used position determination scheme
[0188] At step 506, the injection location (as being associated
with the registered anchor point) to use next as derived at step
504 is displayed e.g. on the display of the position determination
device, the separate electric device, or in another suitable
way.
[0189] At step 507, the user moves the liquid drug administration
device (and thereby the position determination device) to the
presented suggested injection location.
[0190] For relevant embodiments, at least one indicator element,
e.g. a warning light or LED like 203 in FIGS. 2a-3b, and 9, will
activate and stay activated until the position determination device
is moved within a predetermined threshold distance of the injection
location that was displayed at step 506.
[0191] The predetermined threshold may be defined in the user's
entered guidelines or be an overall general threshold.
[0192] 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 like 202 in FIGS. 2a-3b, is activated to
signal that it is ok to perform an injection at the current
injection location.
[0193] At step 508, 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. like 201 shown in FIGS. 2a-3b, and 9) 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 in FIGS. 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 with FIGS. 1, 3a-3b, and 8-9). 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.
[0194] 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 in
FIGS. 1 and 7) and/or a liquid drug administration device (e.g. 200
shown and explained in connection with FIGS. 1, 3a-3b, and 8-9) and
stored there for later use and/or retrieval. After the transmission
is completed, the position determination device may deactivate and
the method ends at step 509. 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.
[0195] FIG. 6 schematically illustrates a flow chart of one
embodiment of a calibration method of a position determination
device.
[0196] The method starts or initiates at step 601 and at step 602
the user activates the position determination device (e.g. a
position determination device as disclosed herein such as one shown
and explained in connection with FIGS. 1-3b and 8-9 and variations
thereof or alternatively of another type) by pressing an
appropriate activation element (e.g. 201 shown in FIGS. 2a-3b, and
9).
[0197] At step 603, the user moves the position determination
device, or rather moves the liquid drug administration device (e.g.
200 shown and explained in connection with FIGS. 1, 3a-3b, and 8-9)
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 in FIGS. 1 and 7).
[0198] This starting position is intended to be used for the
following position determinations (e.g. at least until a next
(re-)calibration).
[0199] At step 604, 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 in FIGS. 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 with FIGS. 1, 3a-3b,
and 8-9).
[0200] 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.
[0201] 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 in FIGS. 1 and 7) and/or a liquid drug administration
device (e.g. 200 shown and explained in connection with FIGS. 1,
3a-3b, and 8-9) for storage and/or visual feedback to the user.
[0202] At step 606, 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.
[0203] At step 607, the user moves the position determination
device and the liquid drug administration device to the shown
anchor position.
[0204] At step 608, 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 in FIGS. 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 with FIGS. 1,
3a-3b, and 8-9) 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 in FIGS. 2a-3b, and
9). 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.
[0205] At step 609, 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 at
step 605 for the starting position.
[0206] At step 610 it is checked whether this procedure is to be
done for any further anchor points. If yes, the method loops back
to step 606 whereby steps 606-610 is repeated in connection with
the next anchor point. If no (signifying no remaining anchor
points), the calibration process terminates at step 611.
[0207] In this way, simple and reliable calibration is
provided.
[0208] It is noted, that the methods illustrated and described in
connection with FIGS. 4, 5, and 6 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.
[0209] FIG. 7 schematically illustrates a separate electric device
displaying a `heatmap` view or similar of earlier injections.
[0210] Shown is a separate electric device 300, e.g. corresponding
to the one shown in FIGS. 1 and 7, having a display 310 to be used
according to some aspects in connection with some embodiments of a
position determination device as disclosed herein (e.g. such as 100
shown in FIGS. 1-3b, 8-9, and variations thereof or of another
type) and a liquid drug administration device (e.g. such as 200
shown in FIGS. 1 and 3a-3b, 8-9, and variations thereof or of
another type).
[0211] 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.
[0212] 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.
[0213] 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.
[0214] 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.
[0215] In a recommendation mode (e.g. as indicated in FIG. 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.
[0216] 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.
[0217] FIG. 8 schematically illustrates an embodiment of a locking
mechanism for attaching an embodiment of a position determination
device to a drug administration device.
[0218] Shown is an embodiment of a position determination device
100 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.
[0219] In this and corresponding embodiments, the position
determination device 100 as disclosed herein comprises one
exemplary embodiment of an attachment element in the form of a
locking mechanism 701 configured to releasably engage with a mating
or corresponding locking mechanism 801 of the liquid drug
administration device 200. The shown drug administration device 200
comprises a cap 210 and a main body 211. More specifically, the
locking mechanism 701 is configured to engage with a locking
mechanism 801 of the main body 211 of the drug administration
device 200 that normally is used to engage a locking mechanism of
the cap 210, i.e. the locking mechanism 701 of the position
determination device 100 corresponds to the locking mechanism of
the cap in that they will be the same or at least similar or
compatible.
[0220] In some further embodiments, and as shown, the locking
mechanism 701 is further configured to engage with the locking
mechanism 702 of the cap 210 (see e.g. also 702 in FIG. 9) so that
the cap 210 still can be attached to the drug administration device
200 even with the position determination device 100 in place, now
just connecting with the position determination device 100 instead
of directly to the drug administration device 200.
[0221] The locking mechanism 701 allows the user an easy way to
attach/detach the position determination device 100 to/from the
drug administration device 200 in a reliable way. The specific
embodiment of such a locking mechanism 701 will typically depend on
the specific shape, size, and/or form of the cap 210 of the drug
administration device 200 and how this attaches to the main body of
the drug administration device 200.
[0222] FIGS. 9a and 9b schematically illustrate an embodiment of
the position determination device attached to a drug administration
device and by itself.
[0223] Shown in FIG. 9a is illustrated an embodiment of the
position determination device 100 attached to a drug administration
device 200 as disclosed herein, respectively, where the cap 210 of
the drug administration device 200 is also attached to the main
body 211 of the drug administration device 200. The cap 210 is
shown transparently and with a cut-out to illustrate parts of the
main body 211 of the drug administration device 200. The attachment
is done using a locking mechanism 701 as disclosed herein. In some
embodiments of the locking mechanism 701, and as shown, it further
comprises an engaging element 702 for allowing a locking mechanism
of the cap 210 to engage so that the cap 210 may be attached to the
position determination device 100 instead of to the main body 211
of the liquid drug administration device 200 (see e.g. also FIG.
8).
[0224] The shown liquid drug administration device 200 also
comprises an activation button 201, as well as a number of
indicator elements here in the form of a confirmation light or LED
202, a warning light or LED 203, and a wireless communications
connection light or LED 204 for user feedback as disclosed
herein.
[0225] FIG. 10 schematically illustrates an exemplary sound signal
emitted from a liquid drug administration device when incrementing
and decrementing 10 (as an example) drug dosage units,
respectively.
[0226] 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.
[0227] Shown is a graph 1000 comprising an exemplary sound signal
or profile 1001 (forth only denoted sound profile) as obtained by a
suitable sound sensor where the x axis indicates time and they axis
indicates amplitude of the sound profile 1001.
[0228] 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.
[0229] 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 spikes 1002 are similar to each
other and the dosage decrement spikes 1002' are similar to each.
Furthermore, the dosage increments spikes 1002 are different to the
dosage decrement spikes 1002'. 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.
[0230] 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).
[0231] For sound profiles of the type shown in FIG. 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.
[0232] 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.
[0233] 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.
[0234] 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.
[0235] 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.
[0236] 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).
[0237] 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.
[0238] 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.
[0239] 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.
[0240] 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.
[0241] Shown is a graph 1100 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 signals 1101, 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.
[0242] The exemplary vibration signals 1101, 1101', 1101'' have
been obtained for a drug administration device that incorporates a
spring mechanism for priming the dosage.
[0243] As clearly can be seen, seven spikes 1102 are present in
each vibration signal 1101, 1101', 1101''--one for each of the
exemplary seven drug dosage unit increases.
[0244] 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.
[0245] 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 with FIG. 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.
[0246] In this way, at least one accelerometer or movement
detection element may be used to reliably capture the changes in
dosage using vibration signals.
[0247] 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.
[0248] Similar vibration signals may likewise be used for detecting
decreasing a drug dosage and/or actual drug administration.
[0249] 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.
[0250] To further increase precision and reliability of detecting
dosage settings (and dosage delivery), a combination of both sound
(e.g. as described in connection with FIG. 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.
[0251] 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.
[0252] FIGS. 12a and 12b schematically 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.
[0253] Illustrated in FIG. 12a is cross section of a position
determination device 100 and a liquid drug administration device
200 as generally disclosed herein. The liquid drug administration
device 200 is a liquid drug administration device 200 of a first
type, i.e. a first liquid drug administration device 200. The
position determination device 100 comprises a main body or housing
1201 and a first separable and interchangeable part 1202 (also
referred to herein as fitter or fitter component) being attached,
in this particular and corresponding embodiments, to the main body
or housing 1201 via a number (here two as an example) of securing
elements 1220. The first separable and interchangeable part 1202
also connects with (or otherwise accommodates) the first liquid
drug administration device 200, in this particular example by
receiving it (fully or partly). The main body or housing 1201
comprises the position determination element, the one or more
processing units, and other functional elements as disclosed
herein.
[0254] Illustrated in FIG. 12b is a cross section of a position
determination device 100 with the same main body or housing 1201 as
in FIG. 12a but now attached to a different separable and
interchangeable part 1202' (i.e. a second separable and
interchangeable part 1202') that connects with (or otherwise
accommodates) a second liquid drug administration device 200' being
of different shape, type, etc. than the first liquid drug
administration device 200.
[0255] As can be seen, this allows for changing between respective
separable and interchangeable parts only in order to accommodate or
connect the position determination device 100--or rather its main
body or housing 1201--with different drug administration
devices.
[0256] In some alternative embodiments, the main body or housing
1201 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'.
[0257] 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.
[0258] 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.
[0259] 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 liquid drug
administration device 200, 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.
[0260] 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.
[0261] 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.
[0262] 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.
[0263] 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.
[0264] 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.
[0265] 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.
* * * * *
References