U.S. patent application number 14/380255 was filed with the patent office on 2015-01-15 for medical apparatus and method.
This patent application is currently assigned to POLYPHOTONIX LIMITED. The applicant listed for this patent is Polyphotonix Limited. Invention is credited to Luke Stuart Barclay, Duncan Hill, Martin Neil Holland, Richard Anthony Kirk, Thomas Snell.
Application Number | 20150018900 14/380255 |
Document ID | / |
Family ID | 45939977 |
Filed Date | 2015-01-15 |
United States Patent
Application |
20150018900 |
Kind Code |
A1 |
Kirk; Richard Anthony ; et
al. |
January 15, 2015 |
MEDICAL APPARATUS AND METHOD
Abstract
A medical apparatus and method of operating a medical apparatus
are disclosed. The apparatus includes a radiation source for
emitting radiation towards an area to be treated of a patient; a
mount element arranged to be worn by the patient for positioning
the radiation source in a predetermined position relative to the
area to be treated; a sensor element arranged to provide a signal
indicative of whether the apparatus is being worn by the patient;
and at least one controller arranged to receive the signal from the
sensor, and to determine whether the apparatus is being worn by the
patient, and to determine duration data indicative of the duration
for which the radiation source emits radiation whilst the apparatus
is being worn by the patient.
Inventors: |
Kirk; Richard Anthony;
(London, GB) ; Holland; Martin Neil; (Maidenhead,
GB) ; Snell; Thomas; (Stockton-on-Tees, GB) ;
Hill; Duncan; (Durham, GB) ; Barclay; Luke
Stuart; (Gateshead, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Polyphotonix Limited |
Sedgefield, Durham |
|
GB |
|
|
Assignee: |
POLYPHOTONIX LIMITED
Sedgefield, Durham
GB
|
Family ID: |
45939977 |
Appl. No.: |
14/380255 |
Filed: |
February 4, 2013 |
PCT Filed: |
February 4, 2013 |
PCT NO: |
PCT/GB2013/050254 |
371 Date: |
August 21, 2014 |
Current U.S.
Class: |
607/88 |
Current CPC
Class: |
A61N 2005/0626 20130101;
A61F 9/029 20130101; A61N 5/0618 20130101; A61N 2005/0662 20130101;
A61N 2005/0648 20130101; A61N 2005/0653 20130101; A61F 9/04
20130101; A61N 5/0613 20130101 |
Class at
Publication: |
607/88 |
International
Class: |
A61N 5/06 20060101
A61N005/06; A61F 9/02 20060101 A61F009/02; A61F 9/04 20060101
A61F009/04 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 22, 2012 |
GB |
GB1203005.2 |
Claims
1. A medical apparatus, comprising: a radiation source for emitting
radiation towards an area to be treated of a patient; a mount
element arranged to be worn by the patient for positioning the
radiation source in a predetermined position relative to the area
to be treated; a sensor element arranged to provide a signal
indicative of whether the apparatus is being worn by the patient;
and at least one controller arranged to receive the signal from the
sensor, and to determine whether the apparatus is being worn by the
patient, and to determine duration data indicative of the duration
for which the radiation source emits radiation whilst the apparatus
is being worn by the patient.
2. A medical apparatus as claimed in claim 1, wherein the
controller is further arranged to control the operation of the
radiation source.
3. A medical apparatus as claimed in claim 2 wherein the controller
is arranged to control the operation of the radiation source such
that radiation is emitted when the signal received from the sensor
element indicates that the apparatus is being worn by the
patient.
4. A medical apparatus according to claim 1, wherein the mount
element comprises a mask, goggles or a visor arranged to be
attached to a patient's face or head, for positioning the radiation
source in a predetermined position relative to at least one eye of
the patient.
5. A medical apparatus according to claim 1, wherein the radiation
source comprises an organic light emitting diode (OLED).
6. A medical apparatus according to claim 5, wherein: wherein the
mount element comprises a mask, goggles or a visor arranged to be
attached to a patient's face or head, for positioning the radiation
source in a predetermined position relative to at least one eye of
the patient; and the radiation source comprises a pair of OLEDs
supported by the mount element such that when the apparatus is used
by a patient each OLED is in a predetermined position relative to
at least one eye of the patient.
7. A medical apparatus as claimed in claim 1 further comprising at
least one further sensor element arranged to provide a signal
indicative of whether the apparatus is being worn by the
patient.
8. A medical apparatus according to claim 1, wherein the or each
sensor element comprises a capacitive sensor supported by the mount
such that when the apparatus is worn by a patient the capacitive
sensor is in close proximity to the patient's skin.
9. A medical apparatus according to claim 1, wherein the or each
sensor element comprises a light emitter and receiver arrangement
supported by the mount such that when the apparatus is worn by a
patient the receiver is prevented from receiving light from the
light emitter.
10. A medical apparatus according to claim 1, wherein the
controller is arranged to control the radiation source such that
radiation is emitted when the signal received from the sensor
element indicates that the apparatus is being worn by the patient
only if a predetermined radiation emission dosage has not been
exceeded.
11. A medical apparatus according to claim 1, further comprising a
memory component arranged to store the duration data.
12. A medical apparatus according to claim 1, further comprising an
output circuit arranged to transmit the duration data.
13. A medical apparatus according to claim 10, wherein the output
circuit comprises an RFID circuit arranged to transmit the duration
data to an associated RFID receiver.
14. A method of operating a medical apparatus for emitting
radiation towards an area to be treated of a patient, comprising:
operating a sensor element to provide a signal indicative of
whether the apparatus is being worn by a patient; supplying the
signal from the sensor element to a controller; and determining
duration data indicative of the duration for which a radiation
source emits radiation whilst the apparatus is being worn by the
patient; using the signal from the sensor element.
15. A method as claimed in claim 14, further comprising controlling
the radiation source such that the radiation source emits radiation
when the signal from the sensor element indicates that the
apparatus is being worn by the patient.
16. A method as claimed in claim 14 wherein the radiation source is
supported by a mount element arranged to be worn by the patient for
positioning the radiation source in a predetermined position
relative to the area to be treated of the patient.
17. A method as claimed in claim 14 further comprising storing the
duration data.
18. A method as claimed in claim 14 further comprising outputting
the duration data for transmission from the apparatus.
19. (canceled)
20. (canceled)
Description
[0001] The present invention relates to a medical apparatus and a
method. In particular, but not exclusively, the present invention
relates to a medical apparatus such as a facial mask, bandage or
plaster for directing radiation into a patient's eyes or other area
requiring treatment, and a method of operating such a medical
apparatus.
[0002] Phototherapy has been used for various therapeutic and
cosmetic purposes. It generally involves the use of specific
wavelengths of light radiation being administered to a patient.
Phototherapy may be used to treat chronic infections such as
hepatitis (A, B or C), bacterial infections, wounds, precancer
conditions, seasonal affective disorder (SAD), various
dermatological and cosmetic purposes such as skin rejuvenation, and
various eye diseases such as diabetic macular edema, retinopathy of
prematurity, wet or dry age-related macular degeneration and
diabetic retinopathy, for example.
[0003] Diabetic retinopathy is a condition in which damage to the
retina in the eye occurs and is caused by diabetes. More
specifically, diabetic retinopathy is the result of microvascular
retinal changes where hyperglycemia-induced intramural pericyte
death and thickening of the basement membrane cause damage to the
wall of blood vessels in the eye. This damage changes the formation
of the blood-retinal barrier and also makes the retinal blood
vessels become more permeable. Small blood vessels, such as those
in the eye, are particularly vulnerable to poor blood sugar
control. An overaccumulation of glucose and/or fructose damages the
blood vessels in the retina. Damaged blood vessels are likely to
leak fluid and lipids onto the macula. This condition can therefore
lead to impaired vision and ultimately blindness. The condition can
be treated by preventing the complete dark adaptation of the eye by
providing some degree of light radiation to the eyes or eyelids
during sleep. This is because, during dark adaptation, the eye
requires an increased oxygen level, and thus the blood vessels must
work harder during dark adaptation. Therefore by preventing
complete dark adaptation of the eye, the blood vessels are less
stressed and can rejuvenate over time. For diabetic retinopathy,
preferably light having a wavelength of between around 460 to 550
nm is administered to the eyes or eyelids, which corresponds to the
scotopic sensitivity of the eye. Of course for other diseases or
conditions, other wavelength ranges may be useful.
[0004] It has been found useful to administer the radiation to the
eye area by providing a mask type of device for a patient to wear
during sleep, the mask configured to be secured over the patient's
head to cover the eye area, and adapted to include light emitting
sources in the region of the eyes. The light sources may be
electroluminescent emitters, light emitting devices, light emitting
cells (LECs), light emitting electrochemical cells (LEECs), LEDs or
OLEDs, for example, and are arranged to emit light towards the eye
area. The radiation acts to stimulate the rods of the eye leading
to hyperpolarization and desensitization of the rod cells, which
lowers their metabolic rates and hence results in a drop in oxygen
consumption in the retina.
[0005] WO2011/135362 discloses a radiation treatment apparatus for
directing electromagnetic radiation into a patient's eyes.
Radiation treatment may be started or stopped by a patient input
(on/off switch) to switch at least one organic semiconductor
radiation emitting device on or off. Preferably the or each organic
semiconductor radiation emitting device comprises an organic light
emitting diode (OLED). Advantageously, the heat output from an OLED
is less that that generated by a conventional light emitting diode
(LED). OLEDs also emit light over a larger surface area than
conventional LEDs, which assists in ensuring that radiation is
directed correctly through the patient's eyelids and pupil to reach
the retina of the eye. The or each OLED is mounted in a mask,
goggles or a visor so that the electromagnetic radiation emitted by
the or each OLED is directed into at least one eye of the patient,
with the or each OLED in a predetermined position relative to the
or each eye of the patient. Preferably, the mask, goggles or visor
are provided with a securing strap or other means for securing the
or each OLED to the patients face or head.
[0006] The radiation treatment apparatus disclosed WO2011/135362
may include a power supply and a controller for controlling the
supply of power to the OLEDs. This provides the flexibility to vary
the time and intensity of radiation exposure as part of a treatment
regime. The duration and conditions of operation of the OLEDs may
be recorded in a memory. In addition, sensor means may be provided
to sense the surroundings of the apparatus, for instance to
deactivate the OLEDs during daylight, or to take account of the
body temperature or movement of the patient.
[0007] However, it is generally known that some patients do not
adhere to the instructions of their doctor, physician or other
advisor in terms of following the instructed treatment dosage
and/or treatment regime, and/or follow the instructions on the
patient information leaflet accompanying a medicine or
apparatus.
[0008] In terms of a radiation treatment apparatus as described in
WO2011/135362, the actual usage of the device by a patient in the
correct manner (e.g. for the correct period of time and for the
correct number of days, etc.), as prescribed by a doctor for
example, cannot be guaranteed.
[0009] The present invention seeks to at least partly mitigate the
above-mentioned problems.
[0010] According to a first aspect of the present invention there
is provided a medical apparatus, comprising: [0011] a radiation
source for emitting radiation towards an area to be treated of a
patient; [0012] a mount element arranged to be worn by the patient
for positioning the radiation source in a predetermined position
relative to the area to be treated; [0013] a sensor element
arranged to provide a signal indicative of whether the apparatus is
being worn by the patient; and [0014] at least one controller
arranged to receive the signal from the sensor, and to determine
whether the apparatus is being worn by the patient, and to
determine duration data indicative of the duration for which the
radiation source emits radiation whilst the apparatus is being worn
by the patient.
[0015] According to a second aspect of the present invention there
is provided a method of operating a medical apparatus for emitting
radiation towards an area to be treated of a patient, comprising:
[0016] operating a sensor element to provide a signal indicative of
whether the apparatus is being worn by a patient; [0017] supplying
the signal from the sensor element to a controller; and [0018]
determining duration data indicative of the duration for which a
radiation source emits radiation whilst the apparatus is being worn
by the patient; using the signal from the sensor element.
[0019] Certain embodiments of the present invention provide the
advantage that the apparatus can itself determine an indication of
how long the apparatus has been used by the patient.
[0020] Certain embodiments of the present invention provide the
advantage that a patient's usage of the apparatus can be recorded
and/or transmitted for monitoring by a doctor or other monitoring
service. Thus, compliance by the patient with a treatment regime
can be determined. In some cases, a patient having knowledge that
such compliance is being monitored will have a higher motivation to
actually follow the treatment regime, thereby improving compliance
with the instructed treatment regime.
[0021] Certain embodiments of the invention provide the advantage
that data corresponding to a patient's usage of the apparatus can
be stored, and/or transmitted continuously, intermittently or upon
request to a receiver (such as a computer operated by the patient's
doctor).
[0022] Embodiments of the invention are further described
hereinafter with reference to the accompanying drawings, in
which:
[0023] FIG. 1 illustrates an exploded perspective view of a
radiation treatment apparatus;
[0024] FIG. 2 illustrates an alternative radiation treatment
apparatus;
[0025] FIG. 3 schematically illustrates a radiation treatment
apparatus according to an embodiment of the present invention;
[0026] FIG. 4 is a partially cut away view of a radiation treatment
apparatus according to an embodiment of the present invention;
[0027] FIG. 5 is a flow chart describing how capacitive sensors are
used within a radiation treatment apparatus according to an
embodiment of the present invention;
[0028] FIG. 6 is a flow chart describing the operation of a
radiation treatment apparatus according to an embodiment of the
present invention; and
[0029] FIGS. 7a and 7b illustrate an alternative radiation
treatment apparatus.
[0030] In the drawings like reference numerals refer to like
parts.
[0031] Certain elements of the apparatus described in WO2011/135362
may be used with the present invention. The contents of
WO2011/135362 are incorporated herein by reference.
[0032] As illustrated in FIG. 1, an exploded perspective view of a
radiation treatment apparatus 2 as disclosed in WO2011/135362
comprises supports (or mounts) 4, 6 to be located adjacent to the
eyes of a patient, the supports 4, 6 each supporting a respective
OLED 14, 16. It will be appreciated that other radiation emitting
devices could be used, though OLEDs are particularly advantageous
for the reasons given above. It has been found that OLEDs emitting
radiation within the range 460 nm to 550 nm, centred at 480 nm to
500 nm, are particularly suitable for treatment of diabetic
retinopathy. This is because when the radiation is filtered through
the eyelids 8, 10 of a patient who is asleep, radiation centred at
about 510 nm reaches the retinas of the patient, which is
particularly efficacious for the treatment of diabetic retinopathy.
Alternatively, radiation centres at about 670 nm may be useful for
the treatment of dry AMD, for example. Of course other ranges of
wavelengths or light radiation are known to be useful to treat
other conditions. It will also be appreciated that the dosage
regime for light radiation will also likely include the time period
for which radiation treatment occurs, the frequency of the periods,
and luminance of the light radiation (measured by candela per metre
squared--cd/m.sup.2). Other conditions will of course require
different dosage regimes. An adjustable strap 12 couples the
supports 4, 6 together so that the spacing between the OLEDs 14, 16
can be matched to the spacing between a patient's eyes. A securing
strap 18 secures the apparatus to the patients head. The OLEDs 14,
16 are powered by at least one battery 20 housed in at least one
recess 22 and activated by a switch 24.
[0033] WO2011/135362 discloses a range of alternative embodiments,
for instance mounting the OLEDs in a face mask. The face mask may
be formed from a flexible material. The face mask may be secured by
a strap similar to strap 18 shown in FIG. 1, or it may, for
instance, be adhesively mounted to the patient's eye socket or
face. Alternatively, the OLEDs could be integrated into a visor
mounted to the patient's head via a head strap. FIG. 2 illustrates
an alternative radiation treatment apparatus disclosed in
WO2011/135362 that takes the form of a mask. The mask comprises a
flexible portion 30 to conform to the shape of the patient's face.
The flexible portion 30 extends to form straps 32 which extend
either around the patient's head or are secured by the patient's
ears passing through apertures 34. The OLEDs 14, 16 are
incorporated into the flexible mask such that they are brought into
close proximity to the patient's eyes. FIG. 2 further illustrates
one or more sensors 36, for instance to sense ambient light levels,
body temperature or movement of the patient for use in controlling
the operation of the apparatus to minimise disturbance to the
user's sleep.
[0034] The present invention provides a radiation treatment
apparatus comprising an improvement to the radiation treatment
apparatuses disclosed in WO2011/135362. As noted above, some
patients may not correctly follow a treatment regime prescribed by
a doctor. Specifically, some patients may not correctly wear the
apparatus or may not wear the apparatus at all, for instance
removing the apparatus before the full prescribed radiation
exposure has been reached for that treatment session. The present
invention allows compliance with a treatment regime to be monitored
by detecting when or for how long the apparatus is worn. This
allows a determination to be made whether the correct radiation
exposure has been delivered to the patient.
[0035] Referring now to FIG. 3, this schematically illustrates
components of an apparatus 100 in accordance with an embodiment of
the present invention. It will be appreciated that the purpose of
FIG. 3 is to present the main functional units of an apparatus in
accordance with an embodiment of the present invention, and places
no limitation on the actual structure of the apparatus. However,
one such structure would be a structure as depicted in FIG. 1 or
FIG. 2, for example. The apparatus 100 comprises at least one
radiation source 102, for instance at least one electroluminescent
emitter, in this case an OLED. The radiation source 102 or each
radiation source may be positioned in or on a mask, goggles or
visor, or other such support structure or mount so as to be placed
in a predetermined position relative to a patient's eye (or other
area to be treated). The support structure may be for example as
generally shown in FIGS. 1 and 2 and as described in WO2011/135362,
and so will not be further described here. The apparatus further
comprises a processor 104 and a battery 106 (or other source of
power, for instance a power supply socket allowing a power supply
wire to be coupled to the apparatus 100). The battery 106 is
coupled to the processor 104 and the radiation source 102 so as to
enable the supply of power to both. The processor 104 is coupled to
the radiation source 102 so as to control the operation of the
radiation source, and in particular to turn the radiation source
102 on and off in accordance with a prescribed treatment regime.
The apparatus further comprises a memory 108 coupled to the
processor 104. The memory 108 is arranged to store instructions for
controlling the processor 104 and data relating to the treatment
regime, for instance intensity of electromagnetic radiation emitted
by the radiation source 102.
[0036] FIG. 3 further illustrates a compliance sensor 110 coupled
to the processor 104. The compliance sensor is arranged to provide
a signal to the processor 104 indicative of whether the apparatus
100 is being worn by the patient. In one embodiment, to be
described in greater detail below, the compliance sensor 110
comprises a capacitive sensor arranged to provide a signal to the
processor 104 indicative of the capacitance at the sensor, which
can be interpreted to determine whether the sensor is close to or
in contact with skin (indicating that the apparatus 100 is being
worn) or whether the sensor is close to or in contact with air
(indicating that the apparatus 100 is not being worn). FIG. 3
further illustrates a clock circuit 112 coupled to the processor
104. The clock circuit 112 is arranged to provide a timing signal
allowing the processor 104 to calculate the duration for which the
apparatus 100 has been worn, or the times at which the apparatus is
put on or taken off, or both. Data relating to when and/or for how
long the apparatus has been worn (hereinafter compliance data) may
be stored in memory 108. Alternatively, or in addition, the
compliance data may be passed from the processor 104 to an output
circuit 114 for transmission to another device. For instance, the
output circuit may be a radio frequency (RF) transmitter arranged
to transmit compliance data wirelessly to a patient's computer, or
directly or indirectly to a doctor's computer to allow compliance
of the patient with a treatment regime to be monitored.
Alternatively, the output 114 could be used to download compliance
data periodically from the memory, for instance when the patient
visits the doctor.
[0037] In addition to passively recording when and/or for how long
the patient has worn the apparatus, the signal from the compliance
sensor 110 may be used to assist the processor 104 in controlling
the radiation source. This may be to ensure that the radiation
source 102 is only activated when the apparatus 100 is being worn.
Additionally, the processor 104 may be adapted to monitor the
duration of radiation exposure while the apparatus 100 is being
worn such that further exposure is prevented, i.e. the radiation
source is switched off, once the prescribed dosage for that dosage
session has been reached. Data relating to the duration of use,
that is data recording the patient's radiation exposure from the
OLED whilst wearing the mask may form part of the compliance data.
By monitoring when the apparatus is worn, embodiments of the
present invention provide an apparatus capable of autonomously
delivering a specific radiation dosage according to a predetermined
treatment regime to the eye, or eyes, or other area of a patient.
Embodiments of the present invention further provide the ability to
make records of, and monitor, compliance with a predetermined
treatment regime.
[0038] A capacitive sensor, such as may be used to form the
compliance sensor 110, is operated by taking a first measurement of
the capacitance of the sensor at a first time and at a second,
later, time taking a second measurement of the capacitance of the
sensor. When a capacitive sensor is exposed to air the capacitance
varies significantly due to natural variations in the surroundings
of the sensor. Conversely, when a capacitive sensor is in contact
with, or in close proximity to, a patient's skin the capacitance
remains more stable. Consequently, if the first and second
measurements of the capacitance of the sensor are close to one
another (within a predetermined tolerance) then this indicates that
the sensor is in contact with or close to the patient's skin (and
hence indicates that the apparatus is being worn). If the two
measurements are further apart than the predetermined tolerance,
then this indicates that the apparatus is not being worn. In one
embodiment a capacitive sensor periodically charges and discharges
at a frequency determined by its capacitance (which, as noted above
varies according to the surroundings of the sensor). The capacitive
sensor may transmit this periodic signal to the processor 104. By
comparison to a regular timing signal received from the clock 112,
the frequency of the signal from the sensor can be determined and
compared with earlier readings to determine whether the apparatus
is being worn.
[0039] Alternatives to capacitive sensors to form the compliance
sensor 110 include thermal sensors, ultrasonic sensors,
photodiodes, a strain gauge that is for example coupled to an
apparatus securing strap (to measure strain as the strap is
stretched when pulling on the apparatus) or coupled to another
portion of the apparatus and capable of measuring bending as the
apparatus is put on, and a blood oxygen monitor. Indeed, any sensor
known in the art capable of providing an indication whether the
apparatus is being worn may be used. Where a capacitive sensor, in
particular, is used it can be desirable to use multiple capacitive
sensors such as two sensors, one on either side of a mask, three
sensors, or four sensors spaced apart around a mask to accommodate
variations in the shape of patient's faces. For instance, for some
patients not all of the sensors may contact the patient's face.
There are surprisingly large variations in facial shapes due to
genetics and origin. In some embodiments it may be sufficient for
one capacitive sensor to register that it is in contact with, or in
close proximity to, the patient's skin to determine that the
apparatus is being correctly worn. Alternatively, it may be
necessary that every sensor, or a predetermined number of sensors,
register that they are in contact with, or in close proximity to,
the patient's skin to determine that the apparatus is being
correctly worn. The higher number of sensors may help to obtain a
more reliable result.
[0040] As noted above, compliance data may be stored within the
apparatus 100 in memory 108, or compliance data may be transmitted
from the apparatus 100 continuously or intermittently, or both. The
method of sending data, e.g. compliance data, to a device (for
example a computer), may be known as machine-to-machine monitoring
(M2M). In a first exemplary embodiment, the output circuit 114 may
be an RFID chip such that compliance data stored in memory 108 may
be retrieved wirelessly from the apparatus periodically, for
instance when the patient visits their doctor. The apparatus may
optionally include a recharging element using an induction to power
the RFID chip by induction (rather than using battery 106).
[0041] In a second exemplary embodiment, output circuit 114 may
comprise a Bluetooth (RTM) transmitter arranged to transmit
compliance data to an associated device such as a mobile telephone
or a computer, where that data may be stored or further
transmitted, for instance ultimately to a doctor or other person
responsible for monitoring the patient's compliance with the
treatment regime. It will be appreciated that further variations
are possible, for instance using a wired connection to the
apparatus. Wired connections may, for example, be via USB,
FireWire.TM., Thunderbolt.TM. or Lightning.TM.. Alternatively, data
may be communicated via "Li-Fi" (the transmission of communication
using visible light).
[0042] An application (or `app`) specifically created to interact
with the mask may be installed on a mobile telephone (cellular
phone), which may be programmed to store information relating to
the use of the mask. For example, the application may be configured
to log mask wear history (e.g. including total duration of wear and
specific times of wear) and/or set reminders to tell the patient
when they need to wear the mask. The application may also further
transmit data to a doctor or other person responsible for
monitoring the patient's compliance with the treatment regime. It
will be appreciated that software of similar capabilities may
provide the same function when installed on any PC, tablet or other
suitable electronic device. The data from the mask may be
transmitted to the application and/or the software (installed on
any suitable electronic device) via any wireless or wired
means.
[0043] M2M monitoring may use short range wireless communication
(for example in homes and hospitals) which may be via personal area
networks (e.g. Bluetooth.TM., Zigbee.TM., MyWi.TM.) or local area
networks (e.g. Wi-Fi).
[0044] Telehealth refers to the delivery of health-related services
and/or information via telecommunication technologies (and it is
appreciated that this may be known by other names elsewhere).
Telecare is a similar system in which a patient is connected with a
monitoring centre through which an alarm is raised if the patient
requires assistance. The mask of the present invention may be
integrated with such systems to monitor health and/or transmit data
to any required locations. For example, for long range monitoring
(e.g. from a home to a doctor in a different location), these
systems may be utilized to provide communication via the
internet.
[0045] Referring now to FIG. 4, there is shown a partially cut away
view of a radiation treatment apparatus according to an embodiment
of the present invention. Specifically, FIG. 4 illustrates a
printed circuit board (PCB) 120 supporting the OLEDs 102 (for an
apparatus having two OLEDs, one for each eye) and shaped to fit on
or in an eye mask generally of the form illustrated in FIG. 2, 8 or
9. The area A indicates generally where the user's nose may be when
the mask is fitted to the user's face. FIG. 4 shows a processor 104
and four separate capacitive sensors 110, forming compliance
sensors, spaced apart around the periphery of the PCB 120. The
capacitive sensors extend from the PCB as flaps that may be folded
against a user's face. There is also shown a power supply
transistor chip 122 for controlling the supply of power to the
OLEDs and the processor 104. In the embodiment shown in FIG. 4
there is a single processor 104, which additionally implements the
functions of the clock 112, memory 108 and output 114 shown in FIG.
3. It will be appreciated that the PCB shown in FIG. 4 may, as a
whole, be considered as a mount for positioning the various
elements with respect to the user. The PCB can be incorporated into
the design of a mask as in FIG. 2, within the mask structure or
adhered onto a mask structure. Therefore the mask structure itself
may be considered the mount. Forming the main electronic components
onto a PCB structure may help enable a simpler, more cost effective
manufacturing process. Of course it will be realised that the PCB
or mount may be of any suitable shape to fit together with any
suitable facial mask. The PCB or mount may have a different layout
and design when used in a bandage or plaster, for example.
[0046] Referring now to FIG. 5, this illustrates in the form of a
flow chart the process of determining whether the patient is
wearing the apparatus 100 by interpreting the output from a
capacitive compliance sensor 110 in a processor 104. At step S2 the
processor 104 switches on a small current to the capacitive sensor
110, the current being supplied to a processor pin coupled to one
terminal of the capacitive sensor 110. At step S4 a timer
controlled by the clock circuit 112 is reset and started. At step
S6 the processor waits 30 mS (milliseconds) while counting the
number of oscillations of the voltage charging and discharging
across the capacitive sensor. At step S8 the timer is stopped once
30 mS is reached and the number of oscillations is read. At step
S10 a check is made whether the capacitive sensor is turned on.
That is, a check is made whether the previous readings from the
capacitive sensor indicate that the apparatus is being worn. If the
capacitive sensor is ON this indicates that the previous recorded
state of the sensor is that the apparatus is not being worn (the
sensor is not in contact with skin. If the capacitive sensor is on
then at step S12 a check is made whether the number of oscillations
counted in the 30 mS period of time is significantly lower than the
average of previous measurements. When a capacitive sensor is in
contact with, or in close proximity to, skin the capacitive load is
increased, which lowers the number of oscillations. The processor
checks to see whether the oscillation count is lower than the
average by a predetermined proportion or amount. If the answer is
yes then this indicates that the patient has put the apparatus on,
thereby bringing the sensor into contact with skin. Therefore at
step S14 the status of the sensor is set to OFF. This change of
state may be used to update information held in the memory 108 or
sent to the output 114 indicating when and/or for how long the
patient has worn the apparatus. Given the change of state, at step
S16 the running average is reset and a new average calculation
begun with the new reading. At step S18 the power supply to the
capacitive sensor is turned off to conserve power. In order to
conserve power the compliance monitoring functions may be set to
only operate periodically, for instance once per second, such that
for the majority of the time the apparatus is in a reduced power
mode. If at step S12 it is determined that the count of
oscillations is not significantly less than the average value (or
is the same, or higher) it is determined that the patient continues
to not be wearing the apparatus. At step S20 the average number of
oscillations in a 30 mS period is updated. That is, the average of
a predetermined number of previous measurements is updated with the
new measurement allowing the sensor to keep track of gradually
changing capacitive conditions. The process then returns to step
S18.
[0047] Similarly, if at step S10 it is determined that the current
states of the sensor is OFF (indicating that the patient was
wearing the apparatus when the sensor was last checked) then at
step S22 a check is made whether the number of oscillations counted
in the 30 mS period of time is significantly higher than the
average of previous measurements. If the answer is yes then this
indicates that the patient has removed the apparatus. Therefore at
step S24 the status of the sensor is set to ON. At step S16 the
running average is reset and a new average calculation begun with
the new reading and at step S18 the power supply to the capacitive
sensor is turned off to conserve power. If at step S22 it is
determined that the count of oscillations is not significantly
higher than the average value (or is the same, or lower) it is
determined that the patient continues to be wearing the apparatus.
At step S26 the average number of oscillations in a 30 mS period is
updated and the process returns to step S18.
[0048] Referring now to FIG. 6, this illustrates in the form of a
flow chart the main processing loop of a radiation treatment
apparatus according to an embodiment of the present invention. The
flow chart in FIG. 6 operates as a continuous loop until the power
supply is lost, as is the case for the flow chart of FIG. 5.
Similar to FIG. 5, the operation of FIG. 6 is designed to conserve
power by powering down approximately once per second and by using a
lower power and relatively slow 32 kHz clock. Upon powering up each
cycle the processor is arranged to read the capacitive sensors as
described in FIG. 5, update the stored compliance data (or transmit
new compliance data) and then power down again.
[0049] At step S30 the processor checks if the OLED or each OLED is
currently on. If the OLEDs are on then the apparatus cannot be
powered down, so at step S32 the processor waits 1.1 S. If power
down is possible (i.e. the OLED is not switched on) then at step
S34 the processor powers down for 1.1 S before turning on and
measuring the or each capacitive sensors at step S36. At step S38
the processor determines whether at least one sensor on the left of
the apparatus mask and at least one sensor on the right are
indicating that the apparatus is being worn. The processor also
determines if further radiation emissions are necessary to meet the
prescribed radiation emission for that dosage session. If the
answer to both questions is yes then at step S40 the or each OLED
is switched on or remains on. If the answer to at least one
question is no then at step S42 the or each OLED is switched off.
At step S44 the process updates the timers recording the duration
and/or times at which the mask was worn and/or radiation was
emitted while the mask was worn. The process then returns to step
S30.
[0050] A further embodiment of the present invention is shown in
FIGS. 7a and 7b. Apparatus 200 incorporates the general principles
of the embodiments described above, but is arranged to be worn as a
bandage over any area of a user as required. Here the apparatus is
used on the arm 201 of a patient. The bandage may be tied or
adhered to the arm 201 in a known manner. As shown in the
cross-sectional view of FIG. 7b, the apparatus 200 includes a
flexible outer layer 202, which may be soft cotton for example for
patient comfort. The apparatus 200 also includes a radiation source
204, which in this example is an OLED, on the skin-facing side of
the apparatus in use. The radiation source is linked to a
controller (not shown) which may function in the same way as the
processor 104 described above. In turn, the controller is also
linked to a compliance sensor for monitoring the usage of the
apparatus 200, in a similar manner as described above. For ease,
the OLED 204, controller and sensor may be formed on a PCB 205 that
can effectively be laminated onto the outer layer 202. Compliance
can be monitored in the same way with respect to FIGS. 5 and 6.
Optionally, a further inner layer may be included to help improve
patient comfort. Aptly this layer would be transparent at least in
the area of the OLED so as to not interfere with the radiation
emission.
[0051] Various modifications to the detailed designs as described
above are possible. For example at least some of the separate
functional components illustrated in FIG. 3 may be reduced in
number by combining their functions into a single processor. The
skilled person will appreciate that the present invention may be
implemented in hardware or software as required.
[0052] Although the radiation source has been described above as an
OLED, this may be any electroluminescent emitter, light emitting
device, light emitting cell (LEC), light emitting electrochemical
cell (LEEC), LED or similar device.
[0053] Although discrete, intermittent measurements have been
described above, it will be realised that continuous monitoring of
radiation emission or wear by the user may be possible.
[0054] The apparatus of the present invention when embodied as a
facial mask may take the general form as shown in FIG. 1 or FIG. 2,
or other similar form to appropriately locate the radiation source
in the eye region and encompass the above-described features of the
invention. FIG. 8 shows another configuration of a facial mask 80
having a strap or straps 82 and a facial portion 84 for holding the
components of the invention described above. FIG. 9 shows a yet
further configuration of a facial mask 90 having a strap or straps
92 and a facial portion 94. The strap(s) 92 connect with the facial
portion 94 at a lower position on the portion 94 (in the
orientation shown on the drawing and in normal use) compared with
the mask 80. By lowering the relative position of the strap(s) 92,
the strap(s) is provided closer to an opening 96 to the area A
where a user's nose may be located in use. As such, upon
positioning the mask 90 on the head, the tension of the strap(s) 92
acts to increase the width of the opening 96. This may be useful
for users with larger than average noses and/or heads.
[0055] As an optional additional feature, the apparatus of the
present invention may include one or more moisture detector for
detecting the presence of liquid on the apparatus. An internal
moisture detector may be used to determine whether a user has
exposed the apparatus to a wet environment, for example dropping
the apparatus in a drink or bath tub, thereby helping to identify
the liability for damage to the apparatus.
[0056] As an alternative to the above-described arrangement, a
medical apparatus may be provided in which an additional sensor is
provided, such as a capacitance sensor, as a user input control on
the apparatus. The capacitance sensor may be in the form of a
button that a user presses to initiate start-up of the apparatus.
Then, within a predetermined time length such as 10 seconds from
pushing the button, the user should put the apparatus in place on
the area to be treated (as confirmed by the other capacitance
sensors 110). By incorporating such a user-operated sensor, the
apparatus then requires a deliberate act by the user to switch on
the apparatus prior to the monitoring. This may help positively
confirm when the device should be turned on to emit radiation (i.e.
an extra check), and may also help positively reinforce to the user
the need to comply with the specified treatment regime.
[0057] In another alternative arrangement, the sensor element of
the apparatus may be in the form of a light emitter and receiver
arrangement, for example including an infrared light emitter at one
location of the apparatus and a photodetector or diode located at
another location of the apparatus. Aptly, the emitter and receiver
may be respectively located on either side of a nose locating area
of a facial mask, such that by placement of the mask on a user's
face, the user's nose will block any infrared light from the
emitter being received at the receiver. That is, the "line of
sight" of the infrared radiation is blocked by the nose when the
mask is being worn. Thereby, the receiver will be able to provide
an indication (e.g. a signal) to monitor whether the mask is in
place on the user's face, and optionally also for how long the mask
is in place on the user's face by providing a signal to a
controller in a similar manner as described above. Such an
arrangement may be used instead of the compliance sensor 110
described above, or may be used as an addition to one or more
compliance sensor, such as the capacitance sensor described above.
Provision of such an arrangement may help to prevent a user
purposely or inadvertently `cheating the system`, for example where
a facial mask is worn or rides up above the eye area but is still
in contact with the skin.
[0058] In addition to the above-described functions, apparatus
according to the invention may also be programmed with a specified,
predetermined dosage regime, e.g. treatment time length and number
of treatments (e.g. 8 hours treatment for 10 days), and light
intensity/luminance level. Aptly the intensity may be variable, for
instance at a less bright level at the beginning of a treatment
period (as the user gets used to the apparatus or begins to fall
asleep) and increases to a further brightness level for a next part
of the treatment period.
[0059] In a further variation, the apparatus of the invention may
be designed to receive instructions on a dosage regime that may be
set by a doctor or other instructor. The steps for receiving
instructions may be opposite to the above-described sending of
information from the apparatus. For example, a RF receiver may be
included that receives an input and sends the signal to processor
104. The processor may then control the radiation source 107 in
accordance with the instructions. This may be useful if the dosage
regime for a patient needs to be changed over time, for example as
their health improves. With the above-described invention, a dosage
scheme of radiation can be automatically delivered to a patient
when the apparatus is secured in place on the patient. By
monitoring when and for how long the patient wears the apparatus it
can be monitored whether the full dosage scheme is delivered to the
patient: that is, the patient's compliance with the dosage scheme
can be monitored.
[0060] It will be clear to a person skilled in the art that
features described in relation to any of the embodiments described
above can be applicable interchangeably between the different
embodiments. The embodiments described above are examples to
illustrate various features of the invention.
[0061] Throughout the description and claims of this specification,
the words "comprise" and "contain" and variations of them mean
"including but not limited to", and they are not intended to (and
do not) exclude other moieties, additives, components, integers or
steps.
[0062] Throughout the description and claims of this specification,
the singular encompasses the plural unless the context otherwise
requires. In particular, where the indefinite article is used, the
specification is to be understood as contemplating plurality as
well as singularity, unless the context requires otherwise.
[0063] Features, integers, characteristics, compounds, chemical
moieties or groups described in conjunction with a particular
aspect, embodiment or example of the invention are to be understood
to be applicable to any other aspect, embodiment or example
described herein unless incompatible therewith. All of the features
disclosed in this specification (including any accompanying claims,
abstract and drawings), and/or all of the steps of any method or
process so disclosed, may be combined in any combination, except
combinations where at least some of such features and/or steps are
mutually exclusive. The invention is not restricted to the details
of any foregoing embodiments. The invention extends to any novel
one, or any novel combination, of the features disclosed in this
specification (including any accompanying claims, abstract and
drawings), or to any novel one, or any novel combination, of the
steps of any method or process so disclosed.
[0064] The reader's attention is directed to all papers and
documents which are filed concurrently with or previous to this
specification in connection with this application and which are
open to public inspection with this specification, and the contents
of all such papers and documents are incorporated herein by
reference.
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