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Claims  |
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We claim:
1. A bandage comprising:
a pad positionable in contact with a patient;
a microcontroller contained within the pad; and
a sensor coupled to the microcontroller to provide a signal to the
microcontroller, the signal being related to the status of the pad,
wherein the microcontroller records information related to the signal from
the sensor.
2. The bandage of claim 1 wherein the sensor generates a signal having an
upper limit and a lower limit.
3. The bandage of claim 1 wherein the sensor generates a first signal when
the pad is in a first state, and the sensor generates a second signal when
the pad is in a second state.
4. The bandage of claim 3 further comprising a timer coupled to the
microcontroller for generating a time signal.
5. The bandage of claim 4 wherein the microcontroller records the time at
which the signal from the sensor switches between the first signal and the
second signal.
6. The bandage of claim 3 wherein the sensor is a contact-sensitive sensor
adapted to be positioned between an adhesive strip and the patient.
7. The bandage of claim 1 further comprising an indicator coupled to the
microcontroller such that the microcontroller can activate the indicator
based on the signal from the sensor.
8. The bandage of claim 1 further comprising a data transfer port formed in
the pad, the data transfer port allowing for an external connection to the
microcontroller contained within the pad.
9. The bandage of claim 1 wherein the pad is substantially opaque.
10. The bandage of claim 1 further comprising a power supply connected to
the microcontroller, the power supply being contained in the pad.
11. An eye patch for use in occlusion therapy, the eye patch comprising:
a pad;
a microcontroller contained within the pad, the microcontroller having a
memory capable of storing information;
means for attaching the eye patch to an eye area of a patient; and
a sensor coupled to the microcontroller, the sensor providing a signal to
the microcontroller, the signal from the sensor indicating whether the eye
patch is attached to the patient, wherein the microcontroller records
information related to the signal from the sensor in the memory.
12. The eye patch of claim 11 further comprising a power supply connected
to the microcontroller, the power supply being contained within the pad.
13. The eye patch of claim 11 further comprising a data transfer port
formed in the pad, the data transfer port allowing for an external
connection to the microcontroller, wherein information can be transferred
into and out of the microcontroller through the data transfer port.
14. The eye patch of claim 11 wherein the means for attaching the pad to a
patient is at least one adhesive strip.
15. The eye patch of claim 11 wherein the sensor is a contact-sensitive
sensor positioned between the means for attaching and the patient, such
that the sensor generates a first signal when the eye patch is in contact
with the patient, and the sensor generates a second signal when the eye
patch is out of contact with the patient.
16. The eye patch of claim 15 further comprising a timer coupled to the
microcontroller wherein the microcontroller records the time at which the
signal from the sensor switches between the first signal and the second
signal such that the microcontroller records when the eye patch is in
contact with the patient.
17. The eye patch of claim 16 wherein the timer an oscillator which is
contained within the pad and external to the microcontroller.
18. The eye patch of claim 11 further comprising:
a protective shield having a front and a back, the pad being attached to
the front of the shield; and
a cushion member attached to the back of the shield such that the cushion
member is adapted to contact the patient.
19. An eye patch for use in occlusion therapy, the eye patch comprising:
a pad;
a programmable microcontroller contained within the pad, the
microcontroller having a memory capable of storing information;
means for attaching the pad to a patient over an eye area of the patient;
a power supply connected to the microcontroller and contained within the
pad;
a sensor coupled to the microcontroller, the sensor generating a first
signal when the eye patch is in contact with the patient, and a second
signal when the eye patch is out of contact with the patient;
a data transfer port formed in the pad, the data transfer port allowing for
an external connection to the microcontroller such that information can be
transferred into and out of the microcontroller through the data transfer
port; and
a timer contained within the pad and coupled to the microcontroller, the
timer generating a time-dependent signal, wherein the microcontroller
records the time at which the signal from the sensor switches between the
first signal and the second signal, such that the microcontroller records
when the eye patch is in contact with the patient relative to the time
signal generated by the timer.
20. The eye patch of claim 19 further comprising:
a protective shield having a front and a back, the pad being attached to
the front of the shield; and
a cushioned member attached to the back of the shield such that the
cushioned member is adapted to contact the patient.
21. A method of monitoring a patient wearing a bandage, the method
comprising the steps of:
positioning a microcontroller within the bandage;
securing the bandage to the patient at a desired location;
attaching a sensor to the microcontroller;
positioning the sensor such that the sensor generates a signal based on the
status of the patient and the bandage;
monitoring the signal generated by the sensor; and
recording in memory in the microcontroller information desired from the
signal generated by the sensor.
22. The method of claim 21 further comprising the step of activating a
timer upon initially securing the bandage to the patient such that the
timer forms a basis for determining when the bandage is secured to the
patient.
23. The method of claim 21 further comprising the step of downloading the
recorded information from the memory of the microcontroller to an external
computer such that the recorded information stored within the
microcontroller can be read.
24. The method of claim 21 further comprising the step of positioning a
power supply within the bandage, the power supply providing power to the
microcontroller.
25. A method of determining patient compliance in wearing an eye patch, the
method comprising the steps of:
positioning a microcontroller within the eye patch;
securing the eye patch to the patient at the desired location;
attaching a sensor to the microcontroller;
positioning the sensor between the bandage and the patient such that the
sensor generates a first signal when the bandage is in contact with the
patient and generates a second signal when the bandage is not in contact
with the patient;
monitoring the signal generated by the sensor;
determining when the signal from the sensor changes between the first
signal and the second signal; and
recording in a memory in the microcontroller the time at which the signal
from the sensor changes.
26. The method of claim 25 further comprising the step of activating a
timer upon initially securing the eye patch to the patient, such that the
timer forms a basis for determining when the eye patch is in contact with
the patient.
27. The method of claim 25 further comprising the step of downloading the
recorded information from the memory of the microcontroller to an external
computer, such that the recorded information stored within the
microcontroller can be read.
28. The method of claim 25 further comprising the step of positioning a
power supply within the eye patch the power supply providing power to the
microcontroller and the sensor.
29. The method of claim 25 wherein the step of attaching the sensor
comprises attaching a contact-sensitive sensor. |
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Claims |
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Description |
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BACKGROUND OF THE INVENTION
The present invention relates to a bandage having internal components that
record, process, store and/or deliver information concerning the usage of
the bandage. More specifically, the invention relates to an eye patch that
includes a microcontroller which records, processes, and delivers
information concerning the times the eye patch was worn by a patient.
Amblyopia, often referred to as "lazy eye", generally refers to poor vision
in one eye as a result of improper development during infancy and
childhood. Amblyopia is the most common vision defect of childhood,
occurring in approximately 1%-5% of the population. Amblyopia can be
caused by any condition that affects normal bilateral usage of the eyes
and normal visual development during childhood. In many cases, the
conditions associated with amblyopia may be inherited. The most common
cause of amblyopia is a misalignment of the eyes because of muscle
problems. Other causes include significant differences in focusing between
the two eyes, high amounts of astigmatism, retinal defects, and other
visual disorders such as cataracts. Generally, amblyopia occurs when the
child relies exclusively on his or her better eye for vision. For example,
when the child has one crossed eye because of muscle problems, the crossed
eye effectively "turns off" to avoid double vision, resulting in the child
using only the better eye. As use of the crossed eye diminishes, the
muscles and parts of the brain required for its normal function weaken,
reinforcing the amblyopia, as a feed-forward process.
If amblyopia is detected early in the child's development, treatment is
often very effective (success rates up to 93%) in correcting the
amblyopia. The best approach to manage amblyopia is to detect the
disfunction before the age of two and break the feed-forward spiral of
amblyopic disuse. If amblyopia starts, it can most effectively be cured if
children are adequately treated before the ages of six to seven years. To
correct amblyopia, a child must be made to use the weak eye instead of
relying only upon the strong eye. This is done by occlusion therapy, which
involves patching or covering the strong eye for several hours during the
day, often for weeks to as long as years, to force the weak eye into
usage.
In order to treat amblyopia, a critical factor is patient compliance. Since
amblyopia must be treated when children are under the age of six, it is
often difficult for the physician to determine whethe r the patient is
following the prescribed occlusion therapy. In some studies, the patient
compliance rate has been found to be around 50%. Thus, although specific
patching regimes can be prescribed, until now, their effectiveness has
been difficult to determine. Presently, patient compliance is typically
measured by clinical attendants or by a parental occlusion log book which
details the amount of time a child is wearing the eye patch. While an
occlusion log book is an attempt to monitor occlusion, it suffers from
several weaknesses, such as bias of the third-party recorder and the
inability to monitor the patient for the entire duration of the therapy.
Recently, an occlusion dose monitor (ODM) has been developed to help the
physician more accurately determine patient compliance. The ODM is a
portable datalogger that can measure the time an eye patch is in contact
with the skin by means of a reduced resistance between two miniature
electrocardiogram electrodes. The datalogger is worn in a shoulder bag by
the patient and includes a pair of leads connected between the datalogger
and the eye patch. When a patient is wearing the ODM, the physician can
recover information from the datalogger as to when the eye patch was worn,
giving the physician an objective measurement of how accurately his
therapy has been followed. Before the ODM, it was not possible for the
physician to distinguish between poor patient compliance and physiologic
non-responsiveness to occlusion. By using an ODM, however, the physician
can objectively monitor the period of time the eye patch was worn by the
patient and adjust his dose accordingly.
Although the discussed ODM has been used to measure patient compliance, the
datalogger contained in a shoulder bag is cumbersome and inconvenient for
an otherwise active child to use, especially if occlusion therapy is
prescribed for an extended continuous period of time. Additionally, the
externally worn datalogger is subject to physical damage when worn by a
young child who is active or unconcerned with preventing damage to the
datalogger. Finally, the datalogger can draw abnormal attention to the
young patient, which increases the patient's resistance to treatment.
Thus, it is readily apparent that a compact bandage or eye patch which
includes small and unobtrusive components that can accurately record and
store data concerning the status of the bandage and the patient would be a
great advantage.
BRIEF SUMMARY OF THE INVENTION
The present invention is a bandage that includes components capable of
recording and/or analyzing data related to the use of the bandage. The
components are contained within the bandage so that it can be worn by a
patient with minimal interference in the patient's normal activities.
The bandage of the invention is particularly useful as an eye patch and
includes a pad member that is positionable in contact with the patient.
Preferably, the pad is positioned over an eye of the patient to completely
block that eye's sight. A microcontroller is embedded and completely
contained within the pad. A power supply is also completely contained
within the pad such that the power supply enables the microcontroller.
The bandage of the invention includes a sensor that is connected to the
microcontroller and provides a signal to the microcontroller related to
the status of the pad. In one embodiment of the invention, the sensor
provides a first signal when the pad is in contact with the patient, and
provides a second signal when the pad is out of contact with the patient.
The microcontroller includes a timer and memory that records when the
signal from the sensor changes between the first signal and the second
signal. By recording the changes in the signal from the sensor, the
microcontroller records when the pad is attached to and removed from the
patient. When the eye patch is used according to a doctor's instructions,
the microcontroller functions to monitor and record the amount of time the
eye patch is worn by the patient in an objective manner.
The bandage of the invention further includes a data transfer port formed
in the pad between the microcontroller and the exterior of the pad. The
data transfer port allows the bandage to be interrogated by an external
computer such that the stored information in the microcontroller that is
received from the sensor can be downloaded and analyzed to determine how
the bandage was used by the patient.
By using the bandage of the invention, a physician can more accurately
determine the period of time a patient wore the bandage. In this manner,
the physician can determine whether the patient has complied with the
physician's instructions.
It is an object of the invention to provide a bandage that includes
internal components capable of monitoring and/or recording the status of
the bandage and the patient. More specifically, it is an object of the
invention to provide an eye patch that can monitor and record the amount
of time the eye patch was worn by a patient.
It is another object of the invention to provide a bandage that includes
self-contained components capable of recording information related to the
use of the bandage. Finally, it is an object of the invention to provide a
bandage which can be interrogated by an external computer to read and
analyze the data acquired and stored by the bandage.
Other features and advantages of the invention may be apparent to those
skilled in the art upon inspecting the following drawings and description
thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
The drawings illustrate the best mode presently contemplated of carrying
out the invention.
In the drawings:
FIG. 1 is a front view showing the bandage of the invention as applied over
the eye of a patient;
FIG. 2 is a section view taken along line 2--2 in FIG. 1 showing the data
acquisition components internally mounted within a pad;
FIG. 3 is a perspective view showing the connection between the bandage of
the present invention and an external computer.
FIG. 4 is a detailed circuit diagram showing the internal circuitry used to
acquire data and contained within the bandage; and
FIG. 5 is a flowchart of the operating software for the bandage of the
invention.
DETAILED DESCRIPTION OF THE DRAWINGS
Referring first to FIG. 1, thereshown is the bandage of the present
invention, generally referred to by reference numeral 10. In the preferred
embodiment of the invention, the bandage 10 is an eye patch 12 that
functions to block sight from one eye of a patient 14. Although the
bandage 10 will be discussed as being the eye patch 12 in the present
description, it should be understood that the bandage 10 could take a
variety of different forms or be constructed from a variety of materials
while still operating under the scope of the invention, as will be further
detailed below. As can be seen in FIG. 1, the eye patch 12 is attached to
the face of the patient 14 by a suitable attachment means, such as a pair
of adhesive strips 16. The adhesive strips 16 each pass over the eye patch
12 and make contact with the face of the patient 14. Although the
invention is described as having a pair of adhesive strips 16, it is
contemplated by the inventors that the adhesive strips 16 could be
replaced by a continuous adhesive border surrounding the outer edges of
the eye patch 12. Further, it is contemplated by the inventors that the
attachment means could take several forms, so long as a suitable means
exists for holding the eye patch 12 in place on the patient's face.
In the preferred embodiment of the invention, the eye patch 12 is useful in
occlusion therapy for treating visual disorders, most particularly
amblyopia. Occlusion therapy is a well-known therapy for treating
amblyopia and includes blocking the vision from the patient's good eye,
thereby forcing the patient to use the amblyopic or weak eye exclusively.
For the bandage 10 to work as the eye patch 12, the eye patch 12 must be
sufficiently opaque such that the patient 14 is unable to see through the
eye patch 12. Since the goal of the eye patch 12 is to prevent the patient
14 from having any vision out of their strong eye, the inventors
contemplate an adhesive means completely surrounding the outer peripheral
edges of the eye patch 12 to attach the eye patch 12 to the patient's
face. A continuous adhesive strip surrounding the outer circumference of
the eye patch 12 is contemplated as being the most effective attachment
means, since the continuous adhesive strip would more effectively prevent
the patient 14 from "peeking" out under the bottom of the eye patch 12 to
use their good eye. Since the eye patch 12 is typically used on children
under the age of 6, it is important to prevent the patient 14 from
cheating and using their good eye for vision.
FIG. 2 shows the internal configuration of the bandage 10 used as the eye
patch 12. The eye patch 12 of the preferred embodiment generally includes
three layers; an outer pad 18, a protective shield 20, and a cushion
member 22. The outer pad 18 is a generally soft, cloth-like member having
a series of internal components that gather and store data concerning the
status of the bandage 10, as will be discussed in greater detail below.
Specifically, the outer pad 18 surrounds a circuit board 24. The circuit
board 24 includes a series of components, which are shown in FIG. 4,
mounted on a flat circuit board having a size of approximately 1/2 inch by
1/2 inch. The components mounted on the circuit board 24 are connected to
a power supply 26 by wires 28. Although the power supply 26 is shown as
being located externally from the circuit board 24, it is contemplated by
the inventors that the power supply could be attached to the circuit board
24 while still operating under the scope of the invention. As shown in
FIG. 2, the power supply 26 is completely contained within the outer pad
18 along with the circuit board 24.
The circuit board 24 is connected by further wires 30 to a data transfer
port 32 such that information can be uploaded or downloaded from the
components mounted to the circuit board 24. FIG. 3 schematically shows the
eye patch 12 coupled to a computer 34 by a cable 36 extending between the
data transfer port 32 and an input/output port 38 contained on the
computer 34. Although FIG. 3 shows the computer 34 connected directly to
the eye patch 12, it should be understood that a conventional interface
component may be required between the computer 34 and the eye patch 12 to
condition the signal from the eye patch 12. Additionally, it is presently
contemplated by the inventors that the cable 36 could be replaced by other
equivalent means for transferring data between the eye patch 12 and the
computer 34, such as infrared or radio frequency communication. Along with
being able to download information stored in the eye patch 12, the
computer 34 can be used to program the components mounted to the circuit
board 24 contained within the outer pad 18. In the preferred embodiment of
the invention, the computer 34 could be a conventional personal computer
capable of running a variety of commercially available programs used both
to download information from the eye patch 12 and to program the
components contained on the circuit board 24.
Referring again to FIG. 2, it can be seen that the outer pad 18 is
connected to a protective shield 20 by any known adhesive means, such as a
common adhesive bond between the cloth-like outer pad 18 and the
protective shield 20. In one embodiment of the invention, the protective
shield 20 is a polycarbonate lens having generally the shape shown in FIG.
1. Since the eye patch 12 is placed over the eye of a patient, it may be
desirable to provide protection for the patient's eye.
In the preferred embodiment of the invention, a cushion member 22 is
securely connected to the back face 40 of the protective shield 20. The
cushion member 22 can be formed of any cushion-like material which will
provide an increased level of comfort for the patient wearing the eye
patch 12. Since the cushion member 22 will be in contact with the
patient's skin, it is contemplated that the cushion member 22 will be a
hypo-allergenic material typically used in commercially available
bandages.
Although the eye patch 12 has been described as having a three layer
construction to provide additional protection and comfort for the patient,
it is contemplated by the inventors that the outer pad 18 could be used
alone either as an eye patch 12 or for other purposes that will become
readily apparent in the following discussion. In the preferred embodiment
of the invention, the outer pad 18 is constructed of a generally opaque
material such that the patient 14 is unable to see through the outer pad
18.
In addition to the components described and shown in FIG. 2, a sensor 42 is
also connected to the circuit board 24 by a pair of wires. The sensor 42
is used to make a specific measurement as to the status of the outer pad
18 or the condition of the patient to which the outer pad 18 is attached.
In the embodiment shown in FIG. 1, the sensor 42 is positioned between the
adhesive strip 16 and the skin of patient 14 such that the eye patch 12
can be monitored by the internal components of the outer pad 18 to
determine the duration of time the eye patch 12 is in contact with the
patient 14. By placing the sensor 42 between the adhesive strip 16 and the
patient 14, the sensor 42 provides information to the internal components
contained within the outer pad 18 concerning the amount of time the eye
patch 12 is worn by the patient.
In the preferred embodiment of the invention, the sensor 42 is a
contact-sensitive switch that is in the closed position when the adhesive
strip 16 is in contact with the patient. Specifically, the adhesive strip
16 holds the contact-sensitive switch in the closed position to generate a
first signal when the eye patch 12 is applied to the patient 14. When the
adhesive strip 16 is removed from the patient, the contact-sensitive
switch opens and generates a second signal. Although the invention has
been described as incorporating a contact-sensitive switch as the sensor
42, it is contemplated by the inventors that a wide variety of sensors
and/or switches could be used as the sensor. For example, the sensor 42
could be a heat sensitive sensor, a tactile pressure sensor, an electrical
switch that responds to skin resistance, or any other type of sensor which
measures a variable important to the desired use of the bandage 10. When
the sensor 42 is replaced by one of the contemplated alternatives, the
signal generated by the sensor will vary between an upper limit and lower
limit, rather than the ON and OFF state associated with the
contact-sensitive switch as described above. In either case, the
components mounted to the circuit board 24 are capable of receiving
information from the sensor 42 and storing or processing such information.
It is contemplated by the inventors that the bandage 10 could be modified
for a variety of purposes other than use as the eye patch 12. For
instance, the bandage 10 could be modified such that the sensor 42
monitors the status of a wound to which the bandage 10 is applied. In this
type of embodiment, the sensor 42 could be a pH sensor (or a monitor of
oxygen saturation) that monitors the acidity (or the oxygen tension) of
the wound to determine whether the wound is infected or healing. In any
event, the internal components mounted to the circuit board 24 are capable
of receiving data from the sensor 42 and storing or processing the data
within the internal components mounted to the circuit board 24.
FIG. 4 shows a circuit diagram for the electronic components mounted to the
circuit board 24. The electronic components are centered around a
microcontroller 46. The microcontroller 46 is preferably a programmable
microcontroller that can be programmed by an external programmer in a
conventional manner. In the preferred embodiment of the invention, the
microcontroller 46 is Part No. PIC12C509, sold by the Microchip
Corporation. The factory assigned pin designations for the microcontroller
46 are shown in FIG. 4 for the ease of understanding. The microcontroller
46 can be programmed by a commercially available programming kit, such as
Part No. DV003001-ND, also sold by Microchip. The programmer allows the
user to program the microcontroller 46 by using software loaded onto a
conventional PC.
The power supply 26 is connected to the microcontroller 46 by the wires 28
between the VDD pin 48 and the VSS pin 50. In the preferred embodiment of
the invention, the power supply 26 is a small battery, such as a 3-volt
lithium battery. The power supply 26 provides the required electrical
power to run the microcontroller 46. In addition to being connected to the
power supply 26, the VDD pin 48 and the VSS pin 50 are each connected to
an output terminal 52 and 54, respectively. The output terminals 52 and 54
are each connected by a separate wire to the data transfer port 32. In
this manner, the computer 34 can receive and/or send information from the
VDD pin 48 and the VSS pin 50 separately. For example, through the output
terminal 52, the computer 34 can monitor the current status of the power
supply 26. Additionally, the output terminal 54 connected to the VSS pin
50 provides the computer 34 with a reference voltage to which the output
signals from the microcontroller 46 can be compared.
The sensor 42 is shown in FIG. 4 as being a contact-sensitive switch
operable between an ON and an OFF position. The sensor 42 is connected
between a GP0 pin 56 and ground, such that when the membrane switch is
closed, the GP0 pin 56 is grounded. Since the GP0 pin 56 is directly
affected by the sensor 42, the GP0 pin 56 will also be referred to as the
sensor state pin. An output terminal 58 is also connected to the GP0 pin
56 such that the microcontroller 46 can communicate with the computer 34
through the output terminal 58. In addition to functioning as the sensor
state pin, the GP0 pin 56 will also be referred to as the data output pin
since the microcontroller 46 is able to send its stored information to the
external computer 34 through the GP0 pin 56.
As can be further seen in FIG. 4, a GP1 pin 60 is connected through output
terminal 62 to the data transfer port 32. The GP1 pin 60 will be referred
to as the read-out pin since it is used by the computer 34 to indicate to
the microcontroller 46 that the stored information in the microcontroller
46 is to be sent to the computer 34. A GP2 pin 64 is connected to an
output terminal 66 such that the GP2 pin 64 can communicate with the
external computer 34 through the data transfer port 32. The GP2 pin 64
functions as a data strobe pin such that the external computer 34 will
know when valid data is present on the GP0 pin 56 of the microcontroller
46.
An external oscillator 68 is attached to the microcontroller 46 in the
preferred embodiment of the invention. Although the microcontroller 46
selected in the preferred embodiment includes an internal timing feature,
the external oscillator 68 provides more accurate and reliable timing. The
external oscillator 68 includes a quartz oscillator 69 and a pair of
capacitors 70 and 71. The external oscillator 68 is connected between the
two oscillator pins 72 and 74 on the microcontroller 46. The more reliable
timing of the external oscillator 68 can be important in applications in
which the bandage 10 is used for long durations. However, the oscillator
contained within the microcontroller 46 can be utilized while still
operating within the scope of the invention. A master clear line reset
(MCLR) pin 76 is connected to an output terminal 78. The external computer
34 can supply a reset signal to the microcontroller 46 through the MCLR
pin 76, the importance of which will be discussed below.
Although not shown in the Figures, it is contemplated by the inventors to
include an indicator on the bandage 10 that would be coupled to the
microcontroller 46. The indicator would be activated by the
microcontroller based on | | |
