Note: Descriptions are shown in the official language in which they were submitted.
CA 02290898 1999-11-25
a,
VAGINAL PROBE HAVING AN IMPROVED SENSOR
AND METHOD OF USING SAME
SCOPE OF THE INVENTION
The present invention relates to a probe used to determine the status of one
or more body
conditions of a human and/or animal subject, and more particularly a probe
provided with an
improved sensor which is adapted for insertion into the subject's mouth,
vagina or anus to sense
one or more body characteristics indicative of a given body condition, and a
method of using
such a probe.
BACKGROUND OF THE INVENTION
Vaginal or anal probes which are used to sense or measure a subject's body
characteristics to provide an indication of a particular body condition are
known. United States
Patent No. 5,209,238 to Sundhar, which issued May 11, 1993 discloses one prior
art vaginal
probe. The probe of Sundhar consists of a cylindrically shaped housing which
has positioned
therealong a number of longitudinally spaced electronic bio-sensors embedded
in the probe
surface. In its operation, the probe is used to determine whether or not a
human female is
ovulating by sensing the state of four body characteristics: basal body
temperature; mucous
density; pH level; and LH level. As a result of the sensed values, the user is
provided with a
visual output as to whether or not the received data is indicative of the
presence of a viable egg.
The probe disclosed in U.S. Patent No. 5,209,238 suffers certain disadvantages
in that for
proper operation it is necessary to ensure the positioning of the sensors in
close contact with the
walls of the user's vagina. If gaps may exist between the user's vaginal
tissues and the sensors.
This in turn may lead to false sensor readings indicating a user is not
ovulating when she may be,
or vice versa.
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2
The difficulties associated with the Sundhar probe construction are further
compounded
if the user's vagina is dry. In such a case, air pockets may exist about the
sensors, resulting in
poor contact with the sensed vaginal fluids, increasing the likelihood of
inaccuracies and
misreadings.
In addition, electronic bio-sensors currently available are both costly and
limited in the
types of body characteristics which may be sensed.
SUNB1~IARY OF THE INVENTION
The present invention seeks to overcome those disadvantages of prior art
devices by
providing a probe which has a replaceable strip or substrate which is
releasably secured to the
probe housing to permit the in vitro sensing of one or a number of different
body conditions.
A further object is to provide a probe for sensing body characteristics of an
animal or
human subject and which is adapted for use either orally, vaginally and/or
anally.
Another object of the invention is to provide a probe which may be used to
sense a
condition of human or animal tissues, including diseases or bacteria in meats,
liquids, fish or
poultry to be used for human consumption.
Another object of the invention is to provide a probe having one or more
sensors for
sensing a body characteristic which provides an indication of a user's
existing body condition,
and in which at least one of the sensors is positioned along a surface of the
probe which
substantially conforms to the physiology of the user's body at the point which
the sensor is to be
used.
A further object of the invention is to provide an improved sensor for use in
an oral,
vaginal or anal probe, which permits accurate sensor readings of a body
condition to be taken in
vivos.
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3
A further object of the invention is to provide an improved chemically
activated strip for
use in an oral, vaginal or anal probe, which permits accurate indications of a
body condition to
be taken in vivos.
Another object of the invention is to provide a probe having one or more
sensors adapted
to sense an indication on a chemically activated paper, plastic, metal, glass
or other substrate
which is coated or uncoated, so as to provide the desired indication of a
particular body condition
upon contact with a patient's body tissues or fluids.
A further object of the invention is to provide a probe having one or more
sensors which
may be operated in conjunction with a number of different types of strip media
which provide
indications thereon which are representative of differing body conditions.
Another object of the invention is to provide a probe having an end portion
sized for
insertion into a subject's mouth, vagina or anus, and which includes a number
of sensors which
may be operated either singularly or plurally, in various selected
combinations, or
simultaneously to sense various body characteristics of the subject which are
indicative of
different body conditions.
Another object of the invention is to provide a vaginal probe used to sense a
number of
different and continuous possible body conditions in a human subject by the
selective activation
and deactivation of different sensors disposed thereon.
A further object of the invention is to provide a vaginal probe which may be
used to
sense body characteristics of an animal, and which includes a transponder
transmitter and/or
signal receiver which permits the probe to be identified for use with an
individual animal having
a specific receiver or transponder signal transmitter.
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4
In furtherance of at least some of the foregoing objects, the invention
provides a probe
having at least one, and preferably a number of sensors which are used to
determine the status of
one or more different body conditions of a human or animal subject. Possible
body conditions to
be assessed by the probe include by way of non-limiting examples, the presence
of the viable egg
in a female subject, whether or not a female subject is ovulating or has
ovulated, an indication of
a probable pregnancy or menopause, hormone imbalance, infertility and/or the
presence of a
possible disease or infection in the subject, such as yeast infection, HIV,
thyroid disorders,
AIDS, cancer or hepatitis.
In use of the probe, the sensors are operable to sense one or more of the
subject's body
characteristics which provide indications of the body condition to be
determined. For example,
the sensors may be used to sense body temperature, inhibin, the pH level of
sensed fluids, male
or female hormone levels such as Luteinising hormone (LH) level of vaginal
fluids, cervical
mucous density, estrogen levels, progesterone levels, estradiol levels,
vaginal cavity pressures,
follicle stimulating hormone (Fsh) levels, blood colouration, and/or human
chorionic
gonadotropohin (hCG) hormone levels. Data collected by the sensors is then
processed and
analyzed to determine the status of the particular body condition, and the
calculated information
respecting the status of the subject's body condition is output on a light
emitting diode (LED),
liquid crystal display (LCD), voltage or current display, or by an audio
speaker provided as part
of the probe, and/or presented on a computer screen which is linked to the
probe.
Most preferably, the probe has an elongated end portion which is sized to
permit insertion
into the subject's vagina. The insertable end portion is configured to
releasably retain a medium
which is adapted to provide an indication of the sensed body characteristic
thereon. Suitable
media include flexible, rigid or semi-rigid paper, plastics such as MylarTM
and LexanTM, metal or
other suitable substrates, which may be in the form of strips. The strips may
optionally be
chemically treated or coated. For example, the indication may consist of a
change in current
flow, resistivity, voltage or conductivity along the strip, or changes in
colour, clarity, opaqueness
or shading of or along part or all of the strip. It is to be appreciated that
the indication may result
from a chemical change or reaction between the patient's body fluids, such as
saliva, cervical
CA 02290898 1999-11-25
mucous, vaginal fluid, blood or urine, and the strip, or the partial or
complete dissolutions of
coatings applied over the strip. Optical sensors such as infrared (IR),
ultraviolet (UV) light or
laser and/or current, voltage, resistance or conductivity sensors are provided
at locations on or in
the probe housing so as to provide a reading of the resulting indication on or
along the strip.
Data from the sensors is electronically transmitted to integrated circuitry
for analysis and output.
The insertable portion of the probe may also be contoured so as to have a
complementary
shape to fit the physiology of the subject's vagina, anus or mouth depending
on where the sensor
is to be placed. For example, where the sensor is to be used vaginally on a
human subject, the
probe may include a contoured portion which is characterized by a gently
curving concave
surface. The concave surface curves in a longitudinally extending arc and is
configured for
placement against the anterior wall of a woman's vagina. In this manner, the
insertable end
portion of the probe follows the natural curvature of the anterior vaginal
wall, ensuring close
contact between the probe and the body tissues which make up the subject's
vaginal walls.
The replaceable strip media may be releasably secured to the probe in a number
of
possible manner. For example, the strip media may be provided with an adhesive
backing which
enables it to be secured in place along part of the insertable end portion of
the probe. Optionally,
the probe may be provided with a groove or depression having a complementary
shape to the
strip media to enable its simplified positioning, and ensuring that indicating
regions on the strip
locate the desired position relative to the strip sensors.
The probe could alternately be provided with a covering cap used to retain the
strip in the
desired position, sandwiched at least partially between the cap and the
remainder of the probe.
The covering cap could be configured for mechanical coupling to the probe by
means of a
threaded coupling slot engagement or snap fit arrangement. If desired, fluid
flow slits and/or
grooves could be formed in the covering cap to assist in directing body fluids
towards openings
therein which lead towards the indicating regions in the strip. In an
alternate embodiment, the
insertable portion of the probe may also define a slot which extends into the
probe interior. The
slot is sized to receive and releasably retain the strip medium therein. With
this arrangement, a
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sensor, such as a light sensor, IR sensor, UV sensor, photovolatic cell,
resistance sensor, voltage
and/or current sensor, or conductivity sensor is housed substantially within
the probe interior and
is used to detect indications on or electron flow along the medium.
The optical sensors may include transmitter and receptor elements disposed on
the same
or opposite sides of the medium to detect the indicating colour, opacity or
the like. Where the
strip medium is releasably secured to the outer surface of the probe, the
optical sensor would
include transmitter and receptor elements disposed on the same side of the
strip. If desired the
probe may include electronics which permit the optical sensor to be used with
different strip
medium to provide indications of different body conditions.
Other secondary sensors may also be provided along the insertable end portion
of the
probe. Such secondary sensors may include temperature sensors as well as
biosensors, infrared
(IR) sensors, electrical resistance sensors, electromagnetic radiation
sensors, chemical sensors,
photovolatic sensors, photoconductors and detectors, or thermal imaging
arrays. Other types of
sensors may also be used. The sensors are electronically coupled to the
integrated circuitry
which is either housed within the probe housing itself, and/or an external
computer by means of
either a connecting cable and interface port or by wireless transmitter and
receiver.
Most preferably, the insertable end portion of the probe is configured to
ensure good
contact between the probe sensors and the subject's body fluids and/or
tissues. This
advantageously eliminates air pockets and false readings, and ensures more
accurate sensor
readings.
Where the probe is to be used for veterinary applications, the insertable end
portion of the
probe may be formed having a larger or smaller size, depending upon the animal
with which the
probe is intended to be used. In veterinary applications, the probe preferably
also includes a
transponder signal receiver adapted to receive a transponder signal from a
transponder signal
transmitter mounted on an animal collar or tag. In this manner, the probe may
be electronically
CA 02290898 1999-11-25
7
coded for use with a particular animal, so as to minimize the possibility of
disease transmission
to other animals.
Accordingly, in one aspect the present invention resides in combination a
probe for
sensing a body condition of a human or animal subject and a disposable medium
adapted to
provide an indication thereon which is representative of said body condition
when contacted with
body fluids or tissues from said subject,
said probe including an end portion sized for insertion into said subject's
mouth, anus or
vagina, and a sensor adapted to sense said indication on said medium while
said medium is
secured to said probe and generate data signals representative of said
indication,
an attachment mechanism used to releasably secure said disposable medium to
said end
portion so as to permit its insertion therewith into said subject's mouth,
anus or vagina,
an integrated circuit electronically linked to said sensor for processing said
data signals.
In another aspect, the present invention resides in combination a probe for
sensing a body
condition of a human or animal subject and a disposable medium adapted to
provide an
indication thereon representative of said body condition when contacted with
body fluids from
said subject,
said probe having an end portion sized for insertion into said subject's
mouth, anus or
vagina,
a slot formed in said end portion and extending into an interior of said
probe, said slot
sized to receive said medium therein,
a sensor disposed proximate to said slot, said sensor adapted to sense said
indication on
said medium and generate data signals representative of said indication,
an integrated circuit electronically linked to said sensor for processing said
data signals.
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8
In a further aspect, the present invention resides in combination a probe for
sensing a
body condition of a human or animal subject and a strip medium having an
activatable portion
adapted to provide an indication thereon which is representative of said body
condition when
contacted with body fluids from said subject,
said probe having an end portion sized for insertion into said subject's
mouth, anus or
vagina,
an attachment mechanism releasably securing said medium to said end portion so
as to
permit its insertion therewith into said subject's mouth, anus or vagina, the
attachment
mechanism comprising a removable cover sized for insertion over at least part
of said insertable
end portion,
said medium being releasably retained at least partially by said cover and
said part of said
insertable end portion, said cover permitting substantially unrestricted flow
of said body fluids
therethrough to said activatable portion when said strip medium is retained
thereby.
In a further aspect, the present invention resides in a probe for use with a
disposable
medium having an activatable portion providing an indication of determining a
body condition
of a human subject, the probe comprising,
a generally cylindrical housing elongated along a longitudinal axis and having
a first end
portion sized for insertion into the subject's mouth, vagina or anus, and a
second end portion,
an attachment mechanism for releasably securing said medium to said first end
portion so
as to permit its insertion therewith into said subj ect's mouth, vagina or
anus,
at least one sensor disposed along said first end portion for sensing said
indication and
generating data signals representative of said sensed body characteristic,
an integrated circuit for receiving said data signals from said at least one
sensor and for
processing said data signals, and
CA 02290898 1999-11-25
s,
9
an output electronically linked to said integrated circuit for outputting
information
representing the status of said body characteristic.
BRIEF DESCRIPTION OF THE DRAWINGS
Reference is now made to the following detailed description taken together
with the
accompanying drawings in which:
Figure 1 is a schematic front view of a vaginal probe for use on a human
subject in
accordance with a preferred embodiment of the invention;
Figure 2 is an enlarged exploded view of the end tip of the probe shown in
Figure 1
showing the manner of securing a replaceable strip thereto;
Figure 3 is an enlarged cross-sectional view of the end tip of the probe shown
in Figure 1
taken along lines 3-3;
Figure 4 illustrates schematically a side view showing the placement of the
probe of
Figure 1 during sensor operation;
Figure 5 illustrates schematically a side view of an end tip of the probe in
accordance
with a second embodiment of the invention;
Figure 6 is a schematic view of a probe for use on an animal subject in
accordance with
another aspect of the invention;
Figure 7 is a schematic view of a probe in accordance with a further aspect of
the
invention;
Figure 8 is an enlarged cross-sectional view of the insertable endmost tip of
the probe
shown in Figure 7; and
Figure 9 is an exploded schematic view of the end tip of the probe in
accordance with a
further embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
Reference is first made to Figures 1 to 3 which show a vaginal probe 10 which
is
operable to determine the current status of a number of different body
conditions of a human
CA 02290898 1999-11-25
female patient, including whether or not the patient has conceived, the
presence of possible
diseases or infections, pre and/or post menopause in females, or whether or
not the patient has
ovulated, is currently fertile or ovulating or is about to ovulate.
As seen best in Figure 1, the probe 10 comprises a molded housing 12 which is
formed
having a generally cylindrical shape and which is elongated in a
longitudinally direction. The
housing consists of a semi-rigid rubber or plastic insertable end portion 14
which is sized for
insertion into a woman's vagina 20 (Figure 4) and an external end portion 16
along the exterior
of which are provided operational controls 21 used to operate the probe 10 and
a liquid crystal
display (LCD) 22. The controls 21 include switches used to turn the probe 10
off or on, as well
as switches used to select a specific body condition to be sensed. As will be
described, while
controls 21 and a display 20 are provided, the probe 10 is most preferably
adapted for cordless
use and is housed within a base 39 which includes controls 40 as well as a
primary LCD 41.
The insertable end portion 14 has a maximum lateral thickness T1 (Figure 1)
selected at
between about 0.5 and 2 cm, and preferably about 1 cm. The insertable end
portion 14 extends
from an endmost tip 24 rearwardly to merge into the exterior end portion 16,
and has an overall
axial length of between about 5 and 15 cm. As will be described hereafter with
reference to
Figure 4, the length of the insertable portion 14 is selected so that when the
end portion 14 is
fully inserted into the patient's vagina 20, the tip 24 locates immediately
adjacent to and most
preferably in contact with the patient's cervix 26 (Figure 4).
The probe 10 is used in conjunction with a disposable generally rectangular
flexible strip
34. The strip 34 is formed as a coated cellulose, MylarTM, or LexanTM or other
plastic substrate.
A sensing region 35 (Figure 2) of the strip 34 is provided with a reactive die
or other suitable
chemical coating to provide a visual indication such as colour, shading,
clarity or opaqueness,
which is representative of one or more sensed body conditions when contacted
with vaginal
fluids. For example, the coating may change to a particular colour when
contacted with a
particular hormone concentration. Alternately, part of the coating may
dissolve when contacted
CA 02290898 1999-11-25
11
with fluids having a predetermined pH. Most preferably, the strip 34 also
includes a control
region 35' (Figure 2) which provides a base line or control reading used to
calibrate the probe 10.
Figure 2 shows the probe 10 as including a removable cap 28 which is
configured for
positioning over the end tip 24. The cap 28 is formed having a hollow thimble-
like construction
and is removably secured over the end tip 24 of the probe 10 by the threaded
engagement
between internal threads 29 formed about the open end of the cap 28, and
complementary formed
external threads 30 formed about the probe housing 12. The cap 28 defines an
inner cavity
which is configured to substantially correspond to the profile of the end tip
24 and which further
defines a narrow rectangular recess or positioning groove 32 formed along its
interior surface.
The groove 32 has a complementary profile to that of the replaceable strip 34.
As is shown, the
positioning groove 32 is located so that when the cap 28 is secured over the
tip 24, the strip 34
locates along a forwardmost side portion of the insertable portion 14.
Figures lto 3 show best the tip 24 as including a pair of sensors 36,38. Each
sensor
includes, respectively, an infrared emitter 36a,38a (Figure 2), such as an
infrared diode adapted
to output plused, broadband IR energy, and an infrared receptor 36b,38b
(Figure 2), such as a
photodiode synchronized to receive the pulsed IR energy. The cap 28, recess 32
and sensors
36,38 are positioned so that when the cap 28 is secured to the remainder of
the probe 10 through
coupling of the threads 29 with threads 30, the strip 34 is secured
substantially within the
positioning groove 32 with the sensing region 35 of the strip 34 immediately
adjacent to the
emitter and receptor 38a,38b and the control region 35' of the strip 34
immediately adjacent the
emitter and receptor 36a,36b, as for example is shown in Figure 3.
Slits and/or apertures 33 are formed through the cap 28 adjacent the sensors
36,38, to
permit the substantially unrestricted flow of vaginal fluids through the cap
28 to the recess 32
and strip media 34. The apertures 33 advantageously also permit the visual
inspection of the
sensing region 35 and control region 35' in the qualitative analysis of the
strip 34.
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12
Each of the sensors 36,38 are selected to provide data signals to an
integrated circuit 64
which are representative of a resulting colour, shading, clarity or opacity
indication on the strip
media 34. Sensor 36 is provided as a "control" sensor used to read the control
region 35' and
establish a base line reading. Sensor 38 is used to sense the indication of
the exposed portion of
the strip.
The integrated circuit 64 initially receives all input data signals from the
sensor 38 and
accepts data within specified limits, converting the input data signals to
digital data. The circuit
64 then calculates all input data signals and yields a decision with respect
to the sensed body
characteristic. Data signals from the sensor 36 are similarly input, and the
integrated circuit 64
challenges all decisions for exceptions and validates the decision, and then
displays results. The
integrated circuit 64 further records the input data signals, and exceptions
to the data and
calculated decisions for closer therapeutic scrutiny of any specific session.
It is to be appreciated that the sensor configuration shown in Figures 1 to 3
is
advantageous in that it permits the replacement and substitution of the strip
34 after each test.
Following each test, the cap 28 is removed by unscrewing the threads 29,30 and
the strip 34
replaced. The present invention advantageously allows different types of
strips 34 to be used
with the same probe 10, for sensing different human characteristics. For
example, following the
use of the coated Mylar strip 34 to sense hormone levels, a strip formed from
litmus paper may
be used to sense the pH of vaginal fluids.
Six longitudinally spaced apart secondary sensors 42,44,46,48,50,52 are
positioned
axially aligned with each other along a medial portion of the insertable
portion 14 of the probe
10. By way of non-limiting examples, suitable secondary sensors for use with
the probe 10
would include photovolatic sensors such as those manufactured by Sensors
Unlimited, Inc.,
electro-optic detectors including photoconductors, photodiodes, thermophile
and pyroelectric
sensors such as those sold under the name EPNETM by Abtech Laboratories
Products, as well as
chemoresistance sensors and bio-analytical biotransducers. It is to be
appreciated that the
positioning of the secondary sensors 42,44,46,48,50,52 is most preferably
selected to conform to
CA 02290898 1999-11-25
13
the curvature of part of the patient's anterior vaginal wall 90 (Figure 4) to
ensure that, when
inserted, the secondary sensors 42,44,46,48,50,52 are maintained in close
contact therewith.
This advantageously and substantially eliminates any air pockets between the
secondary sensors
42,44,46,48,50,52 and the patient's vaginal tissues which may give rise to
false sensor readings.
Sensor 42 is a biosensor used to sense human chorionic gonadotrophin (hCG)
levels in
the patient's vaginal fluids. It is generally believed if pregnant, hCG
numbers will tend to
increase following pregnancy. The probe 10 and either the integrated circuit
64 may thereby be
used to analyze two consecutive hCG tests immediately following ovulation as
an indicator of
unlikely pregnancy. hCG hormones produced during pregnancy are detectable in
the blood, urine
or cervical mucous 1 to 2 days after implantation ( 10 days after ovulation).
This hormone
increases rapidly in the first trimester, reaching a peak 60 to 80 days after
fertilization; then
drops off quickly to 10 to 30% of the peak value for the rest of the
pregnancy. It serves to
maintain progesterone production by the corpus luteum in the early part of
pregnancy. By the
time hCG drops at the beginning of the second trimester, the placenta can make
sufficient
progesterone to maintain the endometrium. In general, a sensed hCG level of
less than 5 mILJ/ml
would be generally indicative that the patient was not pregnant.
Sensor 44 comprises an ultrasound sensor used to sense Luteinising hormone
(LH) levels.
As disclosed in U.S. Patent No. 5,209,238 to Sundhar, by ascertaining the
amplitude of reflected
ultrasonic energy from vaginal tissues, it is possible to ascertain the
presence of LH levels in the
patient. These levels in turn may be used to correlate whether or not the
patient has or may be
currently ovulating.
Sensor 46 is an estrogen biosensor which is used to ascertain the levels of
one or more of
estradiol, estrone, and estriol in the patient's vaginal fluids. Sensor 48
also consists of a
biosensor used to sense progesterone levels in the patient's vaginal fluids,
and may be used in
conjunction with sensor 46 to evaluate whether or not the patient has
conceived or about to start
ovulation. Like estrogen, progesterone is made in the ovaries. Progesterone
production begins
rising at ovulation and increases rapidly until it reaches an average
production of about 22
CA 02290898 1999-11-25
14
milligrams per day. If an egg is not fertilized, progesterone production (as
well as that of
estrogen) falls quickly. This initiates the menstrual flow. Progesterone is
necessary for the
survival of a fertilized egg, the resulting embryo, and the fetus throughout
gestation. It is also
the precursor of other steroid hormones including cortisol, aldosterone,
estrogen, and
testosterone. Progesterone has many other functions, among them protecting
against breast
fibrocysts, helping the body use fat for energy, and helping to normalize blot
clotting and blood
sugar levels.
Sensor 50 operates as either a UTI sensor or pH sensor to measure acidity or
alkalinity
via the electrical potential of the vaginal fluids. Sensor 52 consists of
biosensor used to sense the
presence of a possible disease in the patient. In addition, Figure 4 also
shows the probe 10 as
also including a basal body temperature (BBT) sensor 56.
The primary sensors 36,38, as well as the secondary sensors 42,44,46,48,50,
52,56 are
each electronically coupled to the integrated circuit 64 (Figure 1) contained
within the housing
12 by an optical fiber coupling and/or lead wires 66. Power to the probe 10
and sensors
36,38,42,44,46,48,50,52,56 is supplied by an internal battery 70. The
integrated circuit 64 may
also include memory used to store previous data from the patient by date, time
and type of data,
and permit a comparison of stored data from currently sensed data. Optionally,
one or more
amplifiers 71 with signal processing capability may also be housed within the
external end
portion 16 of the probe 10 for use in amplifying the sensor signals. The wires
66 also
electronically link the controls 21 and LCD 22 to the integrated circuit 64,
battery 70 and to the
base unit 39 via an interface port 72. In this manner the controls 21 and/or
40 are used to
selectively actuate and/or receive data from one or a combination of sensors
36,38,42,44,46,48,
50,52,56 depending upon the patient's body condition to be determined. The
controls 21 are also
configured to automatically turn the probe 10 to a "power ofd' state after a
predetermined period
of over-use, to preserve battery 70 life.
In a preferred embodiment, the probe 10 is designed for both portable as well
as in clinic
use by both professional staff as well as by the patent directly. In addition
to the internal battery
CA 02290898 1999-11-25
70, the integrated circuit 64 may also be connected to a computer 75 (Figure
4) via the interface
port 72 located on the external end portion 16 of the probe 10. The interface
port 72 permits the
probe 10 to be linked to a personal computer 75 either wirelessly or through a
control cable 76 in
the manner shown in Figure 4. The computer 75 may be used in place of the base
unit 39 in the
control of the probe 10 and/or to input to and receive output from the probe
10, visually
indicating the status of the patient's body condition which is sensed. Patient
data and medical
history is preferably also stored in the computer 75, including for example,
information as to the
patient's name, social security data, age, known allergies. Optimally, the
personal computer 75
may also be used to store data from previous diagnostic tests to permit a user
to chart changes in
the sensed body characteristics and, for example, provide an indication of a
likely pregnancy or
the like.
The operation of the probe 10 is shown best with reference to Figure 4. The
strip media
34 is positioned within the cap positioning groove 32. The cap 28 is coupled
over the probe end
tip 24 and secured in place by the engagement between the threads 29,30. The
insertable end
portion 14 of the probe 10 is then placed into the patient's vagina 20. The
insertable end portion
14 is inserted into the subject's vagina 20 so that the endmost tip 24 locates
adjacent to the outer
end of the patient's cervix 26, and with the external end portion 16
maintained external to the
patient. Where the probe 10 is used vaginally on a human female, the probe 10
is positioned so
that the sensors 42,44,46,48,50,52 are moved into juxtaposition with the
anterior vaginal wall 90
of the patient's vagina 20. In this position, the basal body temperature
sensor 56 locates in
contact with the posterior vaginal wall 90. When the probe 10 is inserted into
a subject's vagina
20, if the cervix 26 is closed the end tip 24 may be used to apply pressure
against the closed
cervix 26 to facilitate the escape of fluids therefrom. With the probe 10
fully inserted, mucous
from the cervix 26 may pass through the cap apertures 33 to activate the strip
34. The sensors
36,38 are then operated to sense indications, such as change of colour,
opacity, clarity, or
shading on the strip at both the exposed sensing portion 35, as well as the
control portion 35'.
The data from the sensors 36,38 is thereafter processed by the integrated
circuit 64 or exported to
either the base unit 39 or the personal computer 75 (Figure 4) for display
and/or analysis.
Following a determination of the sensor reading, the probe 10 may optionally
be removed and a
CA 02290898 1999-11-25
16
different strip media adapted to provide an indication of a different body
characteristic may be
inserted into the cap positioning groove 32.
The secondary sensors 42,44,46,48,50,52,56 are also actuated by means of
either the
controls 21 on the exterior portion 16 of the probe 10, (or via the computer
75 if the interface
port 72 is used) to sense the desired body characteristic. It is to be
appreciated that the sensors
42,44,46,48,50,52,56 may be operated independently depending upon which body
condition is to
be analyzed, or simultaneously for an overall diagnostic analysis.
Alternately, all of the
secondary sensors 42,44,46,48,50, 52,56 may be continuously operated and the
integrated circuit
64 used to selectively screen and analyze data signals therefrom, depending on
the body
condition to be sensed. Following their activation, data received from the
sensors
42,44,46,48,50,52, 56 is processed by the integrated circuit 64 (or by the
computer 75) to
determine the status of the particular body condition, and the status of the
body condition in their
output to the user via the LCD 22 or the display 41. Data output from each
sensor 42,
44,46,50,52,56 is also compared and validated against each other to ensure an
accurate and true
reading by the probe 10.
While the embodiment of the invention shown in Figures 1 to 4 illustrates the
releasable
cap 28 as securing the strip media 34 along a forwardmost side of the probe
10, the invention is
not so limited. If desired, the cap 28 could secure the strip 34 directly over
the endmost tip 24 of
the probe 10. Alternately, the strip 34 could be provided along a lowermost
side of the probe,
depending upon the characteristic to be sensed. Similarly, while the cap is
shown as being held
in place by a threaded coupling, other means of securing the cap 28 in place
will also become
apparent. By way of non-limiting examples, the cap 28 could be held in
position by friction
engagement between a flange and a complementary shaped slot, by press fitting,
or by
mechanical fasteners such as tabs, pins, clips or the like.
Although Figure 1 illustrates the cap 28 as including the positioning groove
32, it is to be
appreciated that the groove 32 could equally be provided in the surface of the
probe housing 12
or omitted without departing from the spirit and scope of the invention.
Alternately, the probe 10
CA 02290898 1999-11-25
17
or cap 28 may be formed having a key or projection (not shown) configured to
engage a
complementary shaped recess in the strip 34 to ensure its correct positioning.
Figure 5 shows a modified probe end tip 24 in accordance with a further
embodiment of
the invention in which like reference numerals are used to identify like
components. In Figure 5,
the cap 28 is omitted. The strip 34 is provided with an adhesive backing 78
which is used to
releasably secure the strip 34 to the probe 10. The end tip 24 is provided
with a guide recess 80
which extends across the apex of the tip 24 and which is formed having a
substantially
complementary size to the strip media 34. As with the embodiment described
with reference to
Figures 1 to 4, a control sensor 36 consisting of an IR emitter and IR
receptor and a fluid sensor
consisting of an IR emitter and IR receptor are provided in the probe housing
12 immediately
adjacent the recess 80 so as to sense respectively, the indications on both
the control region 35'
and sensed region 35 on the strip media 34.
Figure 5 further shows the probe 10 as including a laser reader 82. The reader
82 is
configured to identify visual indicia such as a bar code 84 which is printed
on the strip 34. The
laser reader 82 is connected to the integrated circuit 64 via the lead wire
66, and may be used to
automatically calibrate the probe 10 for sensing a particular body
characteristic in response to the
bar code information 84.
Figure 6 illustrates a modified probe 10 for use in veterinary applications,
and wherein
like reference numerals are used to identify like components. Like the
apparatus shown in
Figure 1, the probe 10 of Figure 6 is adapted to be used as either a stand
alone unit, or in a
clinical environment if connected to a computer in the manner shown in Figure
4. In a more
economical model, however, the probe 10 could be provided without the computer
interface port
72 restricting the probe 10 to portable in field use.
Figure 6 further shows the probe cap 28 as including a number of fluid
directing flow
grooves 86. The fluid flow grooves 86 are formed in the cap 28 and extend in a
generally
longitudinal orientation towards the apertures 33. The grooves 86 preferably
have approximate
CA 02290898 1999-11-25
18
dimensions of 0.5 to 1 mm in both lateral width and depth and permit the
substantially
unrestricted movement of fluids therealong. The flow grooves 86 assist in
directing any fluids
directly into the cap apertures 33 to ensure complete activation of the strip
media 34. It is to be
appreciated that although not shown, flow grooves or slits could also be
provided within the cap
28 of the vaginal probe 10 described as being for human use with reference to
Figure 1.
Although not essential, the probe 10 of Figure 6 is typically larger in size
than the probe
of Figure 1 described for human use. The probe 10 of Figure 6 could optionally
include
fewer or more secondary sensors 42,44,46,48,50,52,56 depending upon the
characteristics to be
sensed. The probe 10 is additionally provided with an internal transponder
signal receiver 92
which is electronically linked to the LCD display 22, integrated circuit 64
and lead wires 66.
The transponder signal receiver 92 is adapted to receive a signal from a
transponder signal
transmitter 94 which is mounted on a collar 96 to be secured to a subject
animal. The
transponder signal receiver 92 advantageously permits the user to identify
precisely which
animal out of a herd is to be diagnosed with the probe 10. Where highly
contagious diseases
may be present in a herd, the transponder signal receiver 92 is used to
isolate the probe 10 for use
with the infected animal, minimizing the likelihood of cross-infection between
the herd animals.
In addition, the probe 10 integrated circuit 64 is selectively operable for
each coded transponder
signal to provide a stored data base of diagnostics for a number of different
herd animals.
Although the preferred embodiment of the invention illustrates the probe as
having two
primary strip reading sensors 36,38, six secondary sensors 42,44,46,48,50,52
and a basal body
temperature sensor 56, the invention is not so limited. If desired, the probe
10 could equally
include fewer or more primary and/or secondary sensors without departing from
the spirit and
scope of the present invention. Similarly, while Figures 1 and 5 illustrate
the strip media 34 as
being secured to the probe housing 10 by either an adhesive backing 78 or
through the
mechanical clamping of a cap 28, the invention is not so limited and other
means of securing the
strip media to the probe 10 during in vivos data collection are also possible.
Figures 7 and 8
show a differing sensor arrangement in which like reference numerals are used
to identify like
components. Figures 7 and 8 show best the probe 10 as including a modified
sensor arrangement
CA 02290898 1999-11-25
19
at its endmost tip 24. The end tip 24 is provided with an inwardly extending
rectangular slot 120
which extends between l and 2 cm inwardly into the interior of the probe
housing and which has
a width of between about 0.5 and 4 mm. The slot 120 is sized to releasably
receive therein a
disposable fluid absorbent litmus paper strip 122 as the replaceable strip
media.
Like the probe 10 of Figure 1, the probe 10 of Figure 7 is adapted for cord
free operation
and includes a rechargeable battery 110 which is charged by means of a power
base unit 112.
The base unit 112 is adapted to be plugged directly into a wall outlet and
includes an internal
transformer 114 used to regulate the power supply and used to provide charging
power to the
battery 110, as well as microprocessor 116. While the embodiment of the
invention shown in
Figure 1 illustrates the probe housing 12 as including controls 21 and a
liquid display 22 in
addition to the base unit controls 40, it is to be appreciated that the probe
10 could be
preprogrammed from the base unit 39 itself.
Rearwardly from the tip 24, the insertable end portion 14 is provided with a
contoured
portion 136 which is configured to provide a complementary shape and size to
the physiology of
the patient's vagina 20. The contoured portion 136 includes a concave surface
which curves
gently as a longitudinally extending arc a distance of approximately 5 to 8
cm. The curvature of
the contoured portion is generally complementary to the curvature of part of
the patient's vagina
20 (Figure 4). Secondary sensors 44,46,48 are preferably provided as a
longitudinally extending
array along the portion 136, to maintain their close contact with the
patient's vaginal walls.
The optical sensor used to identify the visual indication on sensing region 35
(Figure 8)
of the strip 122 is positioned at the distal end of the slot 120. The optical
sensor consists of an
infrared emitter 126 and an optical receptor 128 positioned upon opposite
sides of the slot 120 so
as to locate on each side of the strip 122 when positioned therein.
In a simplified embodiment, the paper strip 122 consists of litmus paper which
changes
colour having regard to the hCG level in a patient's vaginal fluids. In use, a
strip 122 adapted to
provide the desired indication representing the hCG or other hormone level is
inserted into the
CA 02290898 1999-11-25
slot 120 so as to be frictionally retained thereby and the probe 10 is
inserted into the patient's
vagina. As the distal end of the probe 10 is inserted into the patient's
vagina, fluids from the
vagina are absorbed by the paper strip 122. The absorbed fluids activate the
strip 122 and
provide a colour indication representative of the body condition sensed. The
infrared emitter
126 and receptor 128 are then activated to sense the colour indication on the
indicator portion 35
of the strip 122 which is positioned therebetween.
If insufficient fluid or cervical mucous exists, the subject may alternately
urinate on or
apply blood to the strip 122 and then insert the strip 122 into the slot 120
for analysis.
While the embodiment of the invention Figures 7 and 8 illustrate the infrared
emitter 126
and receptor 128 as being positioned on opposite sides of the strip 122, the
invention is not so
limited. If desired, the infrared emitter and receptor 126,128 could be
positioned on the same
side of the strip and operated to measure reflected light.
In an alternate embodiment shown in Figure 9, in which like reference numerals
are used
to identify like components, the strip 34 may be fixedly secured to the cap 28
for either reuse or
with the entire cap 28 and strip 34 assembly disposed after each use. Where
the cap 28 is
disposable with the strip 24, the cap 28 may be formed from glass, plastics,
spagnum paper or
mixtures thereof for more economical manufacture. With this construction, the
cap 28 is
interchangeable and most preferably is configured to automatically preprogram
the probe 10 to
recognize the strip 34 mounted therein. In one simplified construction, a
series of switches
102,104,106 are provided about the end tip 24 connected to the integrated
circuit by the wires 66.
The activation of a particular switch 102,104,106 causes the integrated
circuit to automatically
preprogram the probe sensors 36,38 for operation with a particular pre-
selected strip 34. The cap
28 is provided with an internally disposed boss 110 positioned to activate the
particular switch
corresponding to the strip 34 retained therein, when the cap 28 is fully
secured in place.
The strip 34 could also be provided with a number of separate indicator
portions, each
responsive to different body conditions. With such a strip, a number of
optical sensors used to
CA 02290898 1999-11-25
21
read the separate indicator portions, or those of different strips may be
movably provided within
the probe housing 12. For example, sensors disposed within the housing may be
selectively
moved into an operational reading position by mounting on a manual or motor
driven turn table,
so as to rotate into the desired reading position depending on the type or
portion of the strip 34 to
be read.
While the preferred embodiment of the invention discloses the strip media as
comprising
coated MylarTM or litmus paper strips used to determine hCG or pH
concentration, other media
including metals, papers, glass or plastics and/or other body conditions may
also be used with the
probe. Similarly, while an infrared emitters 38a and receptors 38b may be
preferred, other
lasers, UV or visible light emitters and receptors may also be used without
departing from the
spirit and scope of the invention. Similarly, the strip 34 could provide a
change in voltage,
current, resistance or conductivity as an indication of the sensed body
characteristic. With this
arrangement, sensors measuring electrical resistance, voltage, current or
conductivity along the
strip could also be employed in place of optical sensors.
While the preferred embodiment of the invention illustrates the probe as
including a
series of longitudinally extending secondary sensors 42,44,46,48,50,52,56 the
invention is not so
limited. If desired, the secondary sensors could be provided in a lateral or
staggered array, or
omitted in their entirety.
Although the preferred embodiment of Figure 7 illustrates the probe 10 as
including a
contoured portion 132 as a preferred construction for use with a human
subject, other contour
configurations are also possible depending upon the intended animal subject
with which the
probe 10 is to be used.
While the embodiment shown in Figures 7 and 8 illustrate the litmus paper
medium as
being inserted through a slot 120 located at the distal most tip 24 of the
sensor 10, the slot 120
could equally be provided as a longitudinally elongated slit extending along
at least part of the
length of the end portion 14.
CA 02290898 1999-11-25
22
Similarly, while the preferred embodiment discloses the probe 10 as sensing
specific
body characteristics of a subject, it is to be appreciated that different
types of sensors may be
used to sense other body characteristics depending on the body condition which
is to be
analyzed. Alternately, the probe 10 may be used to evaluate the condition of
various foods and
liquids to determine their suitability for consumption. In particular, the
probe may be activated
to determine the condition of meats, fish, poultry or other foods or liquids
to detect the presence
of diseases or potentially harmful bacteria.
The detailed description of the invention describes the sensing media as being
in the form
of an elongated rectangular strip. It is to be appreciated that the strip
could be provided with
almost any two dimensional or even three dimensional shape suitable for
mounting on or in the
probe housing.
While the preferred embodiment describes the probe housing as being from a
semi-rigid
rubber or plastic material, the probe housing could be formed partially or
wholly from other
materials including rigid plastics, composites, stainless steel or other
metals.
Although the detailed description describes and illustrates various preferred
embodiments, the invention is not so limited. Many modifications and
variations will now occur
to persons skilled in the art. For a more precise definition of the invention,
reference may be had
to the appended claims.
