U.S. patent application number 16/522115 was filed with the patent office on 2021-01-28 for wearable device for recording motion data.
The applicant listed for this patent is Global Kinetics Pty Ltd. Invention is credited to Richard Byers, Brendan Fafiani, Richard Walker, Rod Wiebenga.
Application Number | 20210022659 16/522115 |
Document ID | / |
Family ID | 1000005326313 |
Filed Date | 2021-01-28 |
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United States Patent
Application |
20210022659 |
Kind Code |
A1 |
Fafiani; Brendan ; et
al. |
January 28, 2021 |
WEARABLE DEVICE FOR RECORDING MOTION DATA
Abstract
A wearable device comprising a data logger, a motion sensor, and
a memory component is disclosed for recording motion data. The
motion sensor may detect movement of the device when worn by a
subject, and the memory component may store motion data from the
motion sensor. A casing may be included for retaining the data
logger and providing a contact barrier between at least part of the
data logger and the subject. The contact barrier may substantially
prevent contact contamination of at least part of the data logger
while the device is worn by the subject for collection and storage
of subject-specific motion data. The casing is controllably
accessible to release the data logger in a substantially
uncontaminated state.
Inventors: |
Fafiani; Brendan; (Port
Melbourne, AU) ; Walker; Richard; (Wheelers Hill,
AU) ; Wiebenga; Rod; (Cremorne, AU) ; Byers;
Richard; (Cremorne, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Global Kinetics Pty Ltd |
Melbourne |
|
AU |
|
|
Family ID: |
1000005326313 |
Appl. No.: |
16/522115 |
Filed: |
July 25, 2019 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G08B 7/06 20130101; A61B
5/0002 20130101; A61B 5/4809 20130101; A61B 5/112 20130101; A61B
2560/0214 20130101; A61B 5/4815 20130101; A61B 5/1118 20130101;
A61B 5/681 20130101; A61B 5/4082 20130101; A61B 5/1101 20130101;
A61B 5/4833 20130101; A61B 5/7455 20130101; A61B 5/7405 20130101;
G08B 21/24 20130101; A61B 5/743 20130101; A61B 2562/0219
20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; G08B 7/06 20060101 G08B007/06; G08B 21/24 20060101
G08B021/24; A61B 5/11 20060101 A61B005/11 |
Claims
1. A wearable device for recording motion data, the wearable device
comprising: a. a data logger having a battery, a motion sensor
configured to detect movement of the wearable device when worn by a
subject, and a memory component configured to store motion data
from the motion sensor; b. a casing and a bezel for retaining the
data logger; c. one or more fasteners configured to couple the
bezel with the casing to securely retain the data logger in the
casing; and d. a strap attached to or integral with the casing for
wearing by the subject; wherein the data logger has side walls, an
under-surface, and a screen on an upper surface thereof, and
wherein the casing and the bezel together form a contact barrier
that prevents contact contamination between the subject and the
side walls and under-surface of the data logger while the wearable
device is worn by the subject for collection and storage of
subject-specific motion data, and wherein the fasteners are
operable only by use of a tool or special skill to control release
of the secure data logger from the casing in a substantially
uncontaminated state.
2. The wearable device according to claim 1, wherein the data
logger includes contact couplings for coupling with a docking
station or cable, and wherein the contact couplings are
inaccessible when the data logger is securely retained in the
casing.
3. The wearable device according to claim 1, wherein the data
logger includes a screen and the wearable device includes a
transparent protector providing a contact barrier between the
screen and the subject.
4. The wearable device according to claim 3, wherein the bezel,
casing and transparent protector substantially prevent contact
contamination of the data logger including the screen by the
subject.
5. The wearable device according to claim 1, wherein the data
logger includes a processor that is configurable to present the
subject with one or medication reminders based on subject-specific
parameters received during configuration of the wearable
device.
6. The wearable device according to claim 5, wherein the data
logger includes one or more of: a. a loudspeaker and the one or
more medication reminders are presented as an audible prompt
emitted from the loudspeaker. b. a screen and the one or more
medication reminders are presented as a visible prompt presented on
the screen; and c. a vibrating element and the one or more
medication reminders are presented as a haptic prompt presented by
the vibrating element.
7. The wearable device according to claim 2, wherein the data
logger is configurable to communicate with an external processor
via the contact couplings, and the external processor is adapted to
perform one or more of: a. configuring the data logger for wear by
the subject during an assessment period; b. processing motion data
stored by the data logger; c. generating a report based on
processed motion data from the data logger; and d. reconditioning
the data logger after wear by the subject.
8. The wearable device according to claim 1, wherein the data
logger and/or component parts thereof are adapted to be refurbished
or recycled.
9. The wearable device according to claim 8, wherein the casing and
the strap are disposable or recyclable.
10. The wearable device according to claim 1, wherein the data
logger is operable for continuous recording of motion data that is
indicative of presence or absence of movement disorder symptoms and
behaviours selected from a group including: bradykinesia,
dyskinesia, tremor, fluctuations, immobility and gait.
11. The wearable device according to claim 1, wherein the data
logger is operable for continuous recording of motion data for a
minimum of 72 hours.
12. The wearable device according to claim 1, wherein the data
logger includes a sensor for determining if the wearable device is
being worn by the subject.
13. A kit for recording motion data, the kit comprising: a wearable
device comprising a data logger having a battery, a motion sensor
configured to detect movement of the wearable device when worn by a
subject, a memory component configured to store motion data from
the motion sensor, a casing and a bezel for retaining the data
logger, and one or more fasteners configured to couple the bezel
with the casing to securely retain the data logger in the casing,
and a strap attached to or integral with the casing for wearing by
the subject, wherein the data logger has side walls, an
under-surface, and a screen on an upper surface thereof, and
wherein the casing and the bezel together form a contact barrier
that prevents contact contamination between the subject and the
side walls and under-surface of the data logger while the wearable
device is worn by the subject for collection and storage of
subject-specific motion data, and wherein the fasteners are
operable only by use of a tool or special skill to control release
of the secure data logger from the casing in a substantially
uncontaminated state; a. a tray for receiving the wearable device;
and b. a carton for housing the tray and the wearable device during
delivery of the wearable device to and from the subject, the carton
having a fastening portion operable by the subject to fasten the
carton closed for delivery of the device, storing motion data from
the subject, to a recipient.
14. The kit according to claim 13, wherein the tray is moulded to
receive one or more accessories for the wearable device, the
accessories including but not limited to: a. a cleaning cloth; and
b. a strap extension.
15. The kit according to claim 13, wherein the tray is moulded to
receive the casing and strap separately from the data logger.
16. The kit according to claim 13, wherein the carton has a
foldable closure and the fastening portion includes an adhesive
with a removable release liner on the foldable closure.
17. The kit according to claim 13, wherein the carton is pre-marked
with a recipient location and postal authority for delivery of the
carton and contents from the subject to the recipient location.
18. The kit according to claim 13, wherein the carton includes a
foldable lid having an inside panel displaying one or both of
instructions for use of the device and instructions for sending the
used device storing motion data from the subject, in the carton, to
the recipient.
19. The kit according to claim 13, wherein the data logger has a
screen and the wearable device includes a transparent protector
providing a contact barrier between the screen and the subject.
20. The kit according to claim 13, wherein the data logger is
adapted to be removed from the casing by the recipient by use of a
tool or special skill.
21. The kit according to claim 13, wherein the data logger and/or
its component parts is adapted to be refurbished or recycled.
22. A system for recording motion data for a subject, the system
comprising: a wearable device comprising: a data logger having a
battery, a motion sensor configured to detect movement of the
wearable device when worn by a subject, a memory component storing
motion data from the motion sensor, a casing and a bezel for
retaining the data logger, one or more fasteners configured to
couple the bezel with the casing to securely retain the data logger
in the casing, and a strap attached to or integral with the casing
for wearing by the subject, wherein the data logger has side walls,
an under-surface, and a screen on an upper surface thereof, and
wherein the casing and the bezel together form a contact barrier
that prevents contact contamination between the subject and the
side walls and under-surface of the data logger while the wearable
device is worn by the subject for collection and storage of
subject-specific motion data, and wherein the fasteners are
operable only by use of a tool or special skill to control release
of the secure data logger from the casing in a substantially
uncontaminated state, and providing a contact barrier between at
least part of the data logger and the subject; a. a configuration
terminal comprising a processor and a communicative coupling
adapted to communicate with the data logger, the configuration
terminal being operable to configure the data logger to record
motion data for a specific subject; and b. an analysis terminal
comprising a processor and a communicative coupling adapted to
communicate with the data logger, the analysis terminal being
operable to extract subject-specific motion data stored on the data
logger and generate one or more subject-specific reports from the
extracted data which present objective characteristics of the
movement data recorded for the specific subject; wherein the casing
is controllably accessible by use of the tool or special skill to
release the data logger in a substantially uncontaminated
state.
23. The system according to claim 22, wherein the configuration
terminal configures the data logger by transmission, through the
communicative coupling, of a configuration file containing
configuration data pertaining to one or more of: a. prescribing or
treating clinician; b. subject; c. body location of the wearable
device during wear; d. medication prescribed to the subject; and e.
concurrent therapies including device assisted therapies.
24. The system according to claim 22, wherein objective
characteristics presented in reports generated by the analysis
terminal include: a. graphs charting bradykinetic and/or dyskinetic
behaviour over time; b. values representing amount or proportion of
time spent in one or more of bradykinesia, dyskinesia, tremor,
immobile, inactive, active; c. values representing a bradykinesia
or dyskinesia score, quality of sleep, and sleep fragmentation; d.
number of steps taken; e. medication dosage compliance; f.
fluctuations; g. device assisted therapy suitability; h. quality of
sleep; i. medication reminders provided; j. medication
acknowledgements; and k. target ranges for one or more objective
parameters contained in the report, such as bradykinesia and
dyskinesia.
25. The system according to claim 22, wherein the data logger has
one or more contact couplings for coupling with one or both of the
configuration terminal and the analysis terminal using a cable or
docking station; and wherein the contact couplings are inaccessible
when the data logger is retained in the casing and bezel.
26. The system according to claim 22, further including a tool for
releasing the data logger from the casing.
27. The wearable device according to claim 11, wherein the data
logger is operable for continuous recording of motion data for up
to at least 10 days.
Description
TECHNICAL FIELD
[0001] The present disclosure relates to a wearable device for
recording motion data. It relates particularly, but not
exclusively, to a wearable device and an associated kit and system
for use in assessment of movement disorders in a continuous,
passive (i.e. non-task based), remote fulfilment model where the
subject being assessed is ambulatory and able to continue daily
living during recording.
BACKGROUND OF THE ART
[0002] A broad range of movement disorders exist. Parkinson disease
(PD) is one of the most prevalent, affecting over 6 million people
globally. PD is a progressive disorder of the nervous system,
affecting the frontal lobe of the brain which controls impulsive
and non-impulsive movement. People with PD have less dopamine, a
neurotransmitter released by brain neurons in the part of the brain
which helps regulate movement. People with PD experience movement
related symptoms such as bradykinesia, rigidity, tremor and
postural instability. Non-movement symptoms may include speech and
swallowing difficulties, cognitive impairment or behavioural
change, and sleep disturbance.
[0003] Skilled neurologists can detect the presence of bradykinesia
and dyskinesia and provide a measure of its severity. However this
is inherently subjective and scores may vary between different
periods of observation performed by a single neurologist and there
can be differences in scores given by different neurologists.
Furthermore, this assessment can only be done when the neurologist
is with the patient, whereas the response to treatment with drugs
such as Levodopa or L-Dopa may fluctuate over the course of the day
and from day to day and thus continuous objective monitoring is
desirable.
[0004] While experienced clinicians can usually detect and estimate
the severity of bradykinesia and other movement disorders during a
period of observation, these disorders are not easily quantified
making disease management and medication management challenging.
Moreover, a period of observation in the clinic is finite
(typically a period of 10 or so minutes) usually requires the
subject to undertake some clinician-directed motor tasks and is
undertaken in an environment that is not familiar to the patient,
potentially altering or exacerbating symptoms from what is
experienced in day-to-day life. Self-reporting of symptoms by
patients can do away with the environmental problem but this can be
unreliable and is also subjective.
[0005] Objective monitoring of movement disorders using a wearable
device would enable clinicians to diagnose and evaluate disease
state and progression more precisely. It would also assist
clinicians to establish e.g. when the management of PD using L-Dopa
related oral therapies was failing and required advanced therapies
such as deep brain stimulation (DBS) to maintain good control of
symptoms.
[0006] Wearable devices exist for the collection of movement
related data however these are not convenient for use in the
assessment of more than one subject due to the risk of transferring
bioburden between subjects. Cleaning can be performed however this
is inconvenient and may damage the device.
[0007] It would be desirable to provide device that overcomes or
ameliorates one or more of the problems associated with known
approaches to monitoring movement disorders such as Parkinson's
disease.
[0008] The discussion of the background included herein including
reference to documents, acts, materials, devices, articles and the
like is included to explain the context of the present disclosure.
This is not to be taken as an admission or a suggestion that any of
the material referred to was published, known or part of the common
general knowledge any other country as at the priority date of any
of the claims.
BRIEF SUMMARY
[0009] Viewed from one aspect, the present disclosure provides a
wearable device for recording motion data, the device comprising: a
data logger having a battery, a motion sensor configured to detect
movement of the device when worn by a subject, and a memory
component configured to store motion data from the motion sensor; a
casing for retaining the data logger and providing a contact
barrier between at least part of the data logger and the subject;
and a strap attached to or integral with the casing for wearing by
the subject; wherein the contact barrier substantially prevents
contact contamination of at least part of the data logger while the
device is worn by the subject for collection and storage of
subject-specific motion data, and wherein the casing is
controllably accessible to release the data logger in a
substantially uncontaminated state.
[0010] In some embodiments, the data logger includes contact
couplings for coupling with a docking station or cable, and wherein
the contact couplings are inaccessible when the data logger is
retained in the casing.
[0011] In some embodiments, the data logger includes a screen and
the device includes a transparent protector providing a contact
barrier between the screen and the subject. The wearable device may
include a bezel configured to releasably couple with one or both of
the data logger and the casing, the bezel, casing and transparent
protector substantially preventing contact contamination of the
data logger including the screen by the subject.
[0012] In some embodiments, the data logger includes a processor
that is configurable to present the subject with one or medication
reminders based on subject-specific parameters received during
configuration of the device. The data logger includes one or more
of: a loudspeaker and the one or more medication reminders are
presented in the form of an audible prompt emitted from the
loudspeaker; a screen and the one or more medication reminders are
presented in the form of a visible prompt presented on the screen;
and a vibrating element and the one or more medication reminders
are presented in the form of a haptic prompt presented by the
vibrating element.
[0013] In some embodiments, the data logger is configurable to
communicate with an external processor via the one or more contact
couplings, and the external processor is adapted to perform one or
more of: configuring the data logger for wear by a subject during
an assessment period; processing motion data stored by the data
logger; generating a report based on processed motion data from the
data logger; reconditioning the data logger after wear by the
subject. Alternatively/additionally, communication between the data
logger and an external processor may be by wireless communication
means.
[0014] In some embodiments, the data logger and/or its component
parts is adapted to be refurbished or recycled.
[0015] In some embodiments, the casing and the band are disposable
or recyclable.
[0016] In some embodiments, the data logger is operable for
continuous recording of motion data that is indicative of the
presence or absence of movement disorder symptoms and behaviours
selected from a group including: bradykinesia, dyskinesia, tremor,
fluctuations, immobility, daytime somnolence, medication adherence,
daytime sleep, night-time sleep, sleep duration, sleep quality and
gait.
[0017] In some embodiments, the data logger is operable for
continuous recording of motion data for a minimum of 72 hours and
up to at least 10 days.
[0018] In some embodiments, the data logger includes a sensor for
determining if the device is being worn by the subject.
[0019] Viewed from another aspect, the present disclosure provides
a kit for recording motion data, the kit comprising: a wearable
device comprising a data logger having a battery, a motion sensor
configured to detect movement of the device when worn by a subject,
a memory component configured to store motion data from the motion
sensor, a casing for retaining the data logger and providing a
contact barrier between at least part of the data logger and the
subject, and a strap attached to or integral with the casing for
wearing by the subject; a tray for receiving the wearable device;
and a carton for housing the tray and the wearable device during
delivery of the wearable device to and from the subject, the carton
having a fastening portion operable by the subject to fasten the
carton closed for delivery of the device, storing motion data from
the subject, to a recipient.
[0020] In some embodiments, the tray is moulded to receive one or
more accessories for the wearable device, the accessories including
but not limited to: a cleaning cloth; and a strap extension. The
tray may be moulded to receive the casing and strap separately from
the data logger.
[0021] In some embodiments, the carton has a foldable closure and
the fastening portion includes an adhesive with a removable release
liner on the foldable closure.
[0022] In some embodiments, the carton is pre-marked with a
recipient location and postal authority such as a prepaid shipping
label, for delivery of the carton and contents from the subject to
the recipient location.
[0023] In some embodiments, the carton includes a foldable lid
having an inside panel displaying one or both of instructions for
use of the device and instructions for sending the used device
storing motion data from the subject, in the carton, to the
recipient.
[0024] In some embodiments, the data logger has a screen and the
wearable device includes a bezel and a transparent protector
providing a contact barrier between the screen and the subject, the
bezel being configured to couple with one or both of the data
logger and the casing, wherein the bezel and the transparent
portion substantially prevent contact contamination by the subject
of the data logger including the screen.
[0025] In some embodiments, the data logger is adapted to be
removed from the casing by the recipient.
[0026] In some embodiments, the data logger and/or its component
parts is adapted to be refurbished or recycled.
[0027] Viewed from another aspect, the present disclosure provides
a system for recording motion data for a subject, the system
comprising: a wearable device comprising: a data logger having a
battery, a motion sensor configured to detect movement of the
device when worn by a subject, a memory component storing motion
data from the motion sensor and a casing for retaining the data
logger and providing a contact barrier between at least part of the
data logger and the subject; a configuration terminal comprising a
processor and a communicative coupling adapted to communicate with
the data logger, the configuration terminal being operable to
configure the data logger to record motion data for a specific
subject; and an analysis terminal comprising a processor and a
communicative coupling adapted to communicate with the data logger,
the analysis terminal being operable to extract subject-specific
motion data stored on the data logger and generate one or more
subject-specific reports from the extracted data which present
objective characteristics of the movement data recorded for the
specific subject; wherein the casing is controllably accessible to
release the data logger in a substantially uncontaminated
state.
[0028] In some embodiments, the configuration terminal configures
the data logger by transmission, through the communicative
coupling, of a configuration file containing configuration data
pertaining to one or more of: prescribing or treating clinician;
subject; body location of the device during wear; medication
prescribed to the subject; and concurrent therapies including
device assisted therapies.
[0029] In some embodiments, objective characteristics presented in
reports generated by the analysis terminal include: graphs charting
bradykinetic and/or dyskinetic behaviour over time; values
representing amount or proportion of time spent in one or more of
bradykinesia, dyskinesia, tremor, immobile, inactive, active;
values representing a bradykinesia or dyskinesia score, quality of
sleep, and sleep fragmentation; number of steps taken; medication
dosage compliance; fluctuations; device assisted therapy
suitability; quality of sleep; medication reminders provided;
medication acknowledgements; and target ranges for one or more
objective parameters contained in the report, such as bradykinesia
and dyskinesia.
[0030] In some embodiments, the data logger has one or more contact
couplings for coupling with one or both of the configuration
terminal and the analysis terminal using a cable or docking
station, and the contact couplings are inaccessible when the data
logger is retained in the casing.
[0031] In some embodiments, the system includes a tool for
releasing the data logger from the casing.
[0032] It is to be noted that any one of the aspects mentioned
above may include any of the features of any of the embodiments of
other aspects mentioned above and may include any of the features
of any of the embodiments described below, as appropriate.
[0033] It is to be understood each of the various aspects described
herein may incorporate features, modifications and alternatives
described in the context of one or more other aspects, such as but
not limited to the various features and functions of a wearable
device, a kit, a system, a data logger, a tool, a carton, a tray
and the like. For efficiency, such features, modifications and
alternatives have not been repetitiously disclosed for each and
every aspect although one of skill in the art will appreciate that
such combinations of features, modifications and alternatives
disclosed for some aspects apply similarly for other aspects and
are within the scope of and form part of the subject matter of this
disclosure.
BRIEF DESCRIPTION OF DRAWINGS
[0034] The present disclosure will now be described in greater
detail with reference to the accompanying drawings. It is to be
understood that the embodiments shown are examples only and are not
to be taken as limiting the scope of the invention as defined in
the claims appended hereto.
[0035] FIG. 1A is an isometric view from above, of a wearable
device according to an embodiment of the disclosure. FIG. 1B is an
isometric view from below, of the wearable device of FIG. 1A.
[0036] FIG. 2 is an exploded view of the wearable device of FIG.
1A.
[0037] FIG. 3 is an isometric view from below, of a data logger
according to an embodiment of the disclosure.
[0038] FIG. 4A is an isometric view from above, of a carton for a
kit according to an embodiment of the disclosure. FIG. 4B is an
isometric view from below, of the carton of FIG. 4A. FIG. 4C is a
top view of a blank for the carton in FIGS. 4A and 4B.
[0039] FIG. 5A is an isometric view from above of a tool for
accessing a data logger in a wearable device according to an
embodiment of the disclosure. FIG. 5B is an isometric view from
below, of the tool of FIG. 5A.
[0040] FIG. 6A is an isometric view from above of a kit according
to an embodiment of the disclosure. FIG. 6B is an isometric view
from above of a moulded tray of a kit according to an embodiment of
the disclosure. FIG. 6C is an isometric view from below, of the
moulded tray of FIG. 6B.
[0041] FIG. 7 is a schematic illustration of a system for recording
motion data in a subject, according to an embodiment of the
disclosure.
[0042] FIGS. 8A to 8F are examples of pages of a report generated
by a system according to embodiments of the disclosure.
DETAILED DESCRIPTION
[0043] Referring firstly to FIGS. 1A, 1B and 2, there is shown a
wearable device 100 for recording motion data. The device 100
comprises a data logger 110 having a battery, a motion sensor
configured to detect movement of the device when worn by a subject,
and a memory component configured to store motion data from the
motion sensor. The motion sensor within data logger 110 may
comprise any motion sensing element capable of generating an
electric output indicative of movement of the subject as detected
by motion of the device 100 while worn, e.g. on the subject's
wrist. The motion sensor may include, for example, an
accelerometer, gyroscope, micro electro mechanical system (MEMS)
device or other inertial sensor although it is contemplated that
pressure, light and other sensors configurable to detect movement
of the device 100 during wear by the subject may be utilised. Data
logger 110 may further include a capacitive sensor or other sensor
for determining if the logger is being worn by a subject or not.
Outputs from the capacitive sensor may be stored by the memory
component. Typically, data logger 110 also includes a processor
that is configurable to control interoperation of the battery,
motion sensor, memory component, capacitive sensor and other
functional features of the data logger.
[0044] Device 100 further includes a casing 120 for retaining the
data logger. In the embodiment illustrated, casing 120 provides a
cradle that contains data logger 110 in a manner that provides a
contact barrier between the subject wearing the device and the
sides and underside of the data logger. The upper surface of data
logger 110 includes a screen 112 and the device 100 includes a
transparent protector 140 providing a contact barrier between the
screen and the subject. Additionally, device 100 includes a bezel
150 which is configured to releasably couple with casing 120, such
that the bezel, casing and transparent protector 140 substantially
prevent contact contamination of data logger 110 including screen
112 by the subject. In some embodiments, bezel 150 may couple with
data logger 110, and these two parts may couple with casing 120 to
securely retain the data logger. In numerous examples, the device
100 is substantially tamper proof such that a special tool or skill
is required to separate bezel 150 from casing 120 to release data
logger 110 from within. It is intended that removal of data logger
110 from casing 120 by hand is difficult, if not impossible for one
not in possession of a special tool or skill.
[0045] It is to be understood, that casing 120 could completely
enclose data logger 110 in a manner that provides a contact barrier
precluding physical contact between any part of the data logger and
the subject. In some arrangements, casing 120 may be a unitary
piece. In other arrangements, casing 120 may comprise two (or more)
parts that cooperate to preclude contact between the subject and
data logger 110. A casing 120 provided in multiple cooperating
parts or a casing cooperating with a bezel 150 as shown in FIGS.
1A, 1B and 2 may incorporate screws, friction fit fasteners or
other fasteners that are operable by a tool to release data logger
110 from casing 120 to provide access to subject-specific motion
data which is recorded during a period of wear of the device 100 by
the subject and stored on the memory component of data logger 110.
Ideally access to a tool to release data logger 110 from casing 120
is restricted to entities having permission to access the
subject-specific motion data.
[0046] Device 100 includes strap 130 which may be attached to or
integral with casing 120 for wearing by the subject. Typically,
strap 130 is configured for wearing of device 100 to the subject's
left or right wrist so that the device may be worn like a watch.
Thus, buckle 131 is utilised with tongue 132 and holes 133 to
appropriately size and secure device 100 on the subject's wrist. It
is to be understood, however, that other fasteners could be adopted
such as e.g. hook and loop fastening materials, magnetic fasteners
and the like. It is also to be understood that strap 130 may be
configured in a manner, or replaced by a fastening that enables
device 100 to be worn on a different body area such as the chest,
ankle, abdomen, thigh, upper arm or the like.
[0047] The contact barrier formed by casing 120, or by casing 120
in conjunction with transparent protector 140 and bezel 150
substantially prevents contact contamination of data logger 110
while the device 100 is worn by the subject for collection and
storage of subject-specific motion data. Because casing 120 is
controllably accessible requiring a special tool or skill to
release data logger 110 in a substantially uncontaminated state,
entities who have access to the subject-specific motion data stored
on the data logger are not exposed to bio burden that could
otherwise be transferred on device 100. Advantageously, this also
makes possible recycling or refurbishment of data logger 110 and
its component parts as the risk of cross contamination or transfer
of bioburden is minimised.
[0048] As shown in FIG. 3, data logger 110 includes contact
couplings 114 which are provided on the underside for coupling with
a docking station or cable. Owing to the casing 120, contact
couplings 114 are inaccessible when the data logger is in use by
the subject. Thus not only does casing 120 prevent contact
contamination of data logger 110 including contact couplings 114,
subject-specific data stored on the data logger is protected since
access to the contact couplings is restricted to entities who have
access to the tool or special skill necessary to release the data
logger from the casing. While the embodiment shows contact
couplings 114 in the form of four physical contacts, it is to be
understood that other data transmission couplings may be adopted
into the form of data logger 110, such as a USB socket or the like
which is configured to contact and communicatively couple with a
corresponding plug, cable or docking station. Further, it is to be
understood that as an alternative or in addition to contact
couplings 114, data logger 110 may include a component for wireless
data transmission e.g. using Bluetooth or other techniques and
standards as would be appreciated by one of skill in the art.
[0049] In preferred embodiments, the processor of data logger 110
is configurable to present the subject with one or medication
reminders based on subject-specific parameters received during
configuration of the device. In the embodiment illustrated, the
data logger processor is configurable to cause screen 112 to
present one or more medication reminders in the form of a visible
prompt presented on the screen. This reminder is accompanied by a
haptic or vibrational cue that is generated by a vibrating element
contained within data logger 110 and controlled by the data logger
processor. In some embodiments, data logger 110 may also include a
loudspeaker and medication reminders may be presented in the form
of an audible prompt emitted from the loudspeaker controlled by the
data logger processor.
[0050] In numerous examples, the data logger processor is also
configurable to receive inputs from the subject. Such inputs may
include, for example, a medication acknowledgement indicating that
the necessary medication has been consumed. This may follow a
medication prompt. In an embodiment where screen 112 is touch
sensitive, such an input may be received e.g. by the user swiping a
finger across the screen (covered by transparent protector 140), or
e.g. depressing an element of casing 120 that in turn actuates a
button on data logger 110, thereby avoiding direct contact between
the subject and the data logger. Preferably, one or more of the
haptic, visible and audible medication reminder prompts are
repeated until a medication acknowledgement is supplied to device
100 by the subject. When a medication acknowledgement input is
supplied by the subject, the data logger processor may respond by
causing presentation of a tick or other display on screen 112, or
causing an audible tone or announcement to be presented by the
loudspeaker.
[0051] When data logger 110 of device 100 is outside the casing
120, it is operable to communicate with one or more external
processors via contact couplings 114 although wireless
communication may be utilised as described above. An external
processor can be utilised to configure data logger 110 for wear by
a subject during an assessment period, process subject-specific
motion data collected during an assessment period and stored by the
data logger 110, and generate one or more reports based on
subject-specific motion data stored by the data logger. A single
external processor may perform all of these functions, or separate
external processors may perform individual functions. It is to be
understood that an external processor may be distributed or
accessed over a secure network, or may reside in a single secure
location.
[0052] After release of data logger 110 from casing 120 using a
special tool or skill, the casing together with strap 130 may be
discarded and disposed of or recycled. The memory component of data
logger 110 is accessed by the external processor through contact
couplings 114 on the data logger which are connected with a docking
station or cable adapted to communicate with the external
processor. Once subject-specific data has been extracted from the
memory component of data logger 110, the data logger may be
returned to the manufacturer for refurbishment or recycling either
in its entirety, or in its component parts.
[0053] Wearable device 100 enables safe and biohazard free use of
data logger 110 for continuous recording of motion data for use in
diagnosis and/or analysis of movement disorder symptoms in a
subject. These symptoms may include, but are not limited to
bradykinesia, dyskinesia, tremor, fluctuations, immobility daytime
somnolence, medication adherence and the like. Recorded motion data
may also be used to monitor sleep (day time and night time)
including duration and quality of sleep, as well as gait and other
movement-related behaviours that are not solely experienced by
those with movement disorders. Advantageously, recording of motion
data using the inventive device is passive, in that the subject is
not required to perform particular tasks to determine the presence
or absence of certain symptoms. Motion data output by the motion
sensor and stored by the memory component may be processed by the
external processor using any suitable methodology. One suitable
methodology is disclosed in WO2009/149520 entitled "Detection of
Hypokinetic and/or Hyperkinetic States", the entire disclosure of
which is hereby incorporated herein by reference.
[0054] Data logger 110 is operable for continuous recording of
motion data. Ideally, to capture a statistically significant set of
motion data for the subject, an assessment period involves wear of
device 100 and collection of motion data for a minimum of 72 hours
and up to at least 10 days, although a period of about 6 days is
often considered to be clinically sufficient.
[0055] FIGS. 4A to 4C and 6A to 6C relate to a kit 600 for
recording motion data. The kit 600 includes a carton 210 for
housing a tray 220 and the wearable device 100 during delivery of
the wearable device to and from the subject. The carton 210 may
have any suitable shape and be manufactured from any material that
is sufficiently rigid to prevent damage to the wearable device
contained during the usual course of delivery by postal or courier
service or the like. Tray 220 also serves to protect device 100 by
being moulded to receive the device in a section that effectively
immobilises the device inside carton 210. Typically the carton is
manufactured from cardboard and the tray is manufactured from a
moulded pulp. Use of these materials is advantageous in that they
are low cost, lightweight, can be printed upon, manufactured using
some recycled materials and can be recycled themselves at the end
of their lifecycle. However there are many other suitable materials
as would be understood by one of skill in the art.
[0056] In numerous examples, tray 220 is moulded to provide a
suitably contoured slot 221 for receiving the wearable device 100.
Spare slots 222, 223 may be provided to receive accessories for the
device such as strap extensions, cloths, folded paper inserts for
instructions, patient forms and the like although it is to be
understood that such slots need not be occupied even when provided
in moulded tray 220. A ledge 224 provided around the internal
periphery of tray 220 may be used to support an instruction insert
or leaflet within carton 210.
[0057] In some embodiments, tray 220 includes slots 221, 223 to
receive the strap 130 and casing 120 separately from the data
logger 210. In this embodiment, some assembly of the wearable
device 100 is required before it can be worn by the subject.
Because it is intended for contact access to data logger 110 to be
restricted to entities, a kit dispatched in this form is not
intended for direct delivery e.g. from the manufacturer to the
subject. Rather, it may be sent to a clinic or other entity e.g.
for configuration of data logger 110 prior to device 100 being
forwarded on to a subject for assessing movement disorder symptoms.
In such an arrangement the entity would fasten the configured data
logger 110 into the casing 120 and bezel 150 to provide a contact
barrier between the data logger and the subject, before returning
it to carton 210 and tray 220 for dispatch to the subject.
[0058] In the embodiment shown in FIG. 4A, carton 210 has a
fastening portion in the form of a lip 211 extending from a lid 212
of the carton. To close carton 210, lip 211 is folded inside the
opposing carton wall 213. Lip 210 is operable to close the carton
containing the device 100 when it has been configured for use by
the subject for recording motion data from the subject for use in
e.g. assessment of movement disorder symptoms. Once the device 100
has been configured and enclosed within carton 210, it may be
further enclosed within a postal bag or the like for dispatch to
the subject. In some embodiments, the carton itself may be
dispatched to the subject, without a postal bag.
[0059] Upon receipt of carton 210 by the subject, it is opened to
reveal the configured device 100 within. In preferred embodiments,
the inside surface 214 of lid 212 contains instructions printed
directly onto the lid material, or on a label affixed to the inside
lid surface, informing the subject on correct use of the device.
Instructions may include how to initialise and wear device 100.
Ideally, the instructions include directions for returning the
device 100 to a recipient. These instructions include directing the
subject to place the device 100 storing motion data from the
subject into the slot 221 of tray 220 and fasten the carton 210
closed by removing release liner 215 from adhesive strip 216 on the
lip 211 before closing the container as described above. Other
fastening means such as a tab and slot arrangement are also
contemplated and within the scope of the disclosure.
[0060] In numerous examples, carton 210 is marked with a recipient
location and postal authority for delivery of the carton and its
contents from the subject to the recipient location. Thus, a
prepaid shipping label may be printed on or affixed to the base
217. Typically, the recipient is an entity who, upon receipt of the
carton 210, removes device 100 and utilises a tool to release the
data logger 110 containing the subject-specific motion data from
the casing 120, and accesses contact couplings 114 to extract the
motion data. The casing 120, strap 130, bezel 150 and transparent
protector 140 may be discarded or recycled.
[0061] An example of a tool 500 utilised to release data logger 110
from casing 120 is illustrated in FIGS. 5A and 5B. Tool 500 has a
handle portion 510 which can be gripped by a user and a lever
extension 520 which is inserted into a corresponding void formed
between the casing 120 and bezel 150 and used as a lever to
overcome the friction fit that otherwise holds the two parts
together. Ideally the void is sized and shaped to be unobtrusive
and difficult to utilise to separate the casing 120 and bezel 150
in the absence of tool 500.
[0062] Ideally, after use the data logger is refurbished or
recycled. Refurbishment of data logger 110 may involve removing and
discarding the bezel 150 and transparent protector 140, inspecting
the data logger, cleansing existing data stored on the memory
component, loading testing firmware via contact couplings 114,
conducting functional testing, loading production firmware,
charging or replacing the battery, placing the data logger in sleep
mode and, if appropriate, fitting a new transparent protector and
bezel. At the conclusion of the refurbishment process, data logger
110 is entirely reconditioned and satisfies the requirements of a
newly manufactured data logger. Since the data logger 110 is
uncontaminated by the first use and other components of the
wearable device are new, there is no risk of contamination by
transfer of bioburden from the wearable device.
[0063] FIG. 7 is a schematic illustration of a system 300 for
recording motion data in a subject 350, according to an embodiment
of the disclosure. The system includes a wearable device 100 as
described above, a configuration terminal 310 and an analysis
terminal 320. Configuration terminal 310 has a processor (not
shown) and a communicative coupling 312 adapted to connect with
contact couplings 114 of the data logger 110. Configuration
terminal 310 is operable to configure data logger 110 to record
motion data for a specific subject 350 while wearing the device
100. Configuration terminal 310 includes a user input device such
as a keyboard 313 or touch screen 314 receiving inputs from an
entity, such as a person or application. The inputs enable the data
logger 110 to be configured for use in recording motion data for a
specific subject.
[0064] The configuration inputs may include data that is specific
to the subject such as e.g. name, date of birth, medications
prescribed, concurrent therapies in place such as device assisted
therapies (e.g. Deep Brain Stimulation--DBS) and bodily location of
the device 100 during wear (e.g. left or right wrist, chest, left
or right ankle etc.). Additionally, the inputs may include data
that is specific to a treating clinician of the specific subject,
such as the clinician's name and location, contact details and the
like. Configuration terminal 310 configures data logger 110 by
transmission of a configuration file that is based on the
configuration inputs, from the configuration terminal processor, to
the device using a docking station or cable 312 contacting contact
couplings 114 of the data logger 110 being configured although
wireless transmission is also contemplated. Ideally, the data
logger 110 is configured for ambulatory and continuous recording of
motion data for subjects having Parkinson's disease or other
diseases that involve movement disorders although the subject need
not have a movement disorder to benefit from use of the device to
record motion data.
[0065] Once data logger 110 is configured it is clipped into a
casing 120 having a strap 130 and packed into the carton 210 with
tray 220 for dispatch via a delivery service a subject 350 for
assessment. Subject 350 receives carton 210, removes device 100 and
wears it for the period indicated in the instructions printed on a
paper insert provided in carton 210 or printed on the carton's
inside lid surface 214. Typically the period of wear (and recording
of motion data) is 6 to 10 days. In some examples, the battery
contained within data logger 110 is sufficient for a period of
continuous monitoring of 6 to 10 days, i.e. the subject does not
need to charge the data logger during the period of wear. In some
embodiments, the battery contained within data logger 110 is
sufficient for a period of continuous monitoring of up to 28
days.
[0066] At the conclusion of the monitoring period, subject 350
replaces the device 100 in the tray 220 in carton 210, and fastens
carton lid 212 closed by removing release liner 215 from adhesive
strip 216 on the lip 211 and closing the container as described
above. In a preferred embodiment, the data logger processor is
configured to cause screen 112 to display an envelope or other icon
or text indicating to the subject that the monitoring period has
ended. Alternatively/additionally a loudspeaker or vibrational
element of data logger 110 may provide an audible and/or haptic
cue, respectively, that the monitoring period has ended.
[0067] The subject returns the carton 210 which is fastened closed
and contains the device 100 with subject-specific motion data
stored on data logger 110 to a recipient. Return of carton 210
containing the device 100 is typically enabled by a prepaid
shipping label which is printed onto or affixed to carton 210 prior
to dispatch to subject 350.
[0068] Upon receipt of carton 210 from the subject, the data logger
110 is released from the casing 120 and strap 130, typically using
a special tool, and discards the casing, strap and packaging. The
stored motion data is extracted from data logger 110 by analysis
terminal 320. This is achieved by connecting contact couplings 114
on the logger 110 with a docking station 322 or cable that permits
transmission of the motion data from the memory component to the
analysis terminal 320 for processing and/or using wireless
transmission. The analysis terminal 320 may, in some embodiments,
reside in docking station 322 or the docking station may, like
cable 312, connect with the terminal e.g. via a USB input. Although
the analysis terminal 320 is shown as separate from configuration
terminal 310 and docking station 322, it is to be understood that
this is for illustrative purposes and to facilitate explanation.
Thus, a single terminal may be utilised to provide the
configuration and analysis functions although these functions may
be distributed across different terminals or indeed across
different networks of interconnected processing devices.
[0069] Analysis terminal 320 is operable to extract
subject-specific motion data stored on data logger 110 and generate
one or more subject-specific reports from the extracted data which
present objective characteristics of the movement disorder symptoms
evident in motion data recorded for the specific subject. An
example of pages from a report of the type contemplated is
illustrated in FIGS. 8A to 8G. Objective characteristics that may
be presented or analysed in reports generated by analysis terminal
320 include but are not limited to graphs 810, 811 charting
dyskinetic and bradykinetic behaviour over time respectively, a
table 812 presenting patient results calculated by a processor of
analysis terminal 320 and reporting on objective measures such as
e.g. Median Dyskinesia Score (DKS), percentage of time spent in
Dyskinesia (PTD), Median Bradykinesia Score (BKS), percentage of
time spent in tremor (PTT), percentage of time spent immobile
(PTI), number of steps taken, Dosage Compliance, Fluctuations in
Dyskinesia score (FDS), DBS selection score and the like.
[0070] Report 800 may include a notes region 820 for including
non-chart and non-tabular information such as a legend indicating
the meaning of symbols appearing in charts 810, 811 e.g. where a
capsule icon 821 indicates presentation of a medication reminder to
the subject during assessment and a vertical line 822 denotes a
medication acknowledgement input by the subject. Notes region 820
may also include text or graphical notes manually added by a
technician curating the report generated automatically by the
processor of analysis terminal 320, prior to the report being
dispatched to a clinician for use in determining progress or
treatment of the subjects' movement disorder symptoms.
[0071] Report 800 may take any suitable form however in some
embodiments the report is divided into sections that include e.g.
Daytime Session average scores for BK and DK, Daytime Patient
Results, Daytime Summaries (e.g. for tremor and immobility although
other measures could be indicated), Nighttime Summaries, and Daily
plots for various measures that can be obtained by from the motion
data. The report may also indicate time periods when device 100 is
off the subject's wrist. The processor may generate the report
including, as shown in FIG. 8D, expanded time periods following key
events such as medication reminders or medication acknowledgements,
to provide more detailed views of motion data collected during
periods of time following those events. The report may also
include, as shown in FIG. 8E, longitudinal views of measures such
as DK and BK. The longitudinal views may be generated automatically
by the analysis terminal processor which accesses a repository of
motion data previously obtained from the subject for whom the
report is being generated. The report may also include a Summary
section as exemplified in FIG. 8F.
[0072] In some embodiments, system 300 includes a specially
designed a tool 500 for releasing the data logger from the
casing.
[0073] Advantageously, the present disclosure provides a wearable
device for recording motion data, and a kit and system therefor,
for assessment of subjects having movement disorder diseases such
as Parkinson's disease. Thus, subjects having symptoms of a
movement disorder can, after initial consultation from their
clinician, receive a kit, or carton containing the device and
everything that is needed to complete functional assessment without
the requirement to attend a clinic, or undertake task based tests
as has been the case in the past. Rather, the subject opens the
carton, applies the wearable device like a wrist watch, and carries
on with daily living with minimal interference, inconvenience and
negative impact. In one example, aside from a wrist-worn wearable
device, no sensors are required to be placed elsewhere on the body
and no specific configuration of the device is required to be
performed by the subject who is ambulatory and burden free.
[0074] Owing to the arrangement of the data logger component of the
wearable inside a protective casing and elements that prevent the
subject from physically contacting the data logger, the device is
robust in that there can be no interference by the subject in the
configuration of the device e.g. due to cognitive or physical
impairment. Additionally, concealment of contact couplings within
the casing can minimise the risk of unauthorised or unintended
dissemination of motion and other data stored on the memory
component of the data logger. These aspects, combined with features
of the device relating to medication reminders and acknowledgements
give rise to high patient compliance, both with medication regimens
and wearing of the device for the assessment duration enabling
collection of continuous, high quality motion data.
[0075] A clinician may have on hand one or more data loggers, or
may order them from a supplier, and may utilise a configuration
terminal to configure the data logger for a specific subject who is
a patient of the clinician. In such an arrangement, the clinician
would connect a cable or docking station adapted to connect with
contact couplings, typically on the back of the data logger, to his
or her computer. The computer may be configured with software to
generate a configuration file and push that to the data logger
processor, or to log on to a web based or remotely hosted
application that enables the configuration file to be created and
pushed, via the cable or docking station, to the data logger. Once
configured, the clinician secures the data logger in a casing with
a strap, places it into the tray and dispatches the kit to the
subject. After the subject has utilised the device it is returned
to a recipient for data extraction and reports generated by the
analysis terminal are delivered electronically to the
clinician.
[0076] In other embodiments, a clinician may utilise an ordering
system, ideally an online ordering system which enables the
clinician to enter various subject and clinician--specific input
parameters that enable a third party to configure a device and
deliver it directly to the subject. After the subject has utilised
the device, it is returned for data extraction and analysis and
reports generated by the analysis terminal are delivered
electronically to the treating clinician. This eliminates the need
for the clinician to hold and handle stock and technology with
which it may not be familiar, yet ensures that the clinician can
swiftly order the service and receive reports delivered as part of
the service.
[0077] Where the terms "comprise", "comprises", "comprised" or
"comprising" are used in this specification (including the claims)
they are to be interpreted as specifying the presence of the stated
features, integers, steps or components, but not precluding the
presence of one or more other features, integers, steps or
components or group thereof.
[0078] It is to be understood that various modifications, additions
and/or alterations may be made to the parts previously described
without departing from the ambit of the present disclosure as
defined in the claims appended hereto.
[0079] Future patent applications may be filed in the United States
of America or overseas on the basis of or claiming priority from
the present application. It is to be understood that the following
claims are provided by way of example only, and are not intended to
limit the scope of what may be claimed in any such future
application. Features may be added to or omitted from the claims at
a later date so as to further define or re-define the invention or
inventions.
* * * * *