U.S. patent application number 11/574705 was filed with the patent office on 2008-08-07 for optoelectronic device for the detection of uterine cancer, comprising a self-positioning attachment.
This patent application is currently assigned to Ave Eugenio Garza Sada #2501 Sur, Col. Tecnologic. Invention is credited to Jose Antonio Viornery Escorza, Arturo Hernandez Fuentes, Noel Leon Rovira, Norma Frida Roffe Samaniego.
Application Number | 20080188757 11/574705 |
Document ID | / |
Family ID | 39676773 |
Filed Date | 2008-08-07 |
United States Patent
Application |
20080188757 |
Kind Code |
A1 |
Rovira; Noel Leon ; et
al. |
August 7, 2008 |
Optoelectronic Device For The Detection Of Uterine Cancer,
Comprising A Self-Positioning Attachment
Abstract
The present invention relates to a portable device which
analyses cervical tissue using two simultaneous measurements,
namely an electrical measurement and an optical measurement. The
aforementioned device examines different areas of cervical tissue,
taking electrical measurements from same in different frequency
ranges and optical measurements in three different wavelengths.
Once the measurements have been obtained, they are processed by a
configurable device or microcontroller in accordance with
mathematical formulae obtained from multiple measurements taken
from healthy and cancerous tissues. Three possible responses can be
obtained from the processing of the measurements: healthy tissue,
cancerous tissue or the presence of human papilloma virus. The
inventive device can be used as a self-detection device since it is
equipped with an attachment for positioning same upon detection of
proximity to the cervix in order to take a correct measurement. The
aforementioned attachment also comprises an accessory which can be
used to perform the alternative method in which a cell sample is
taken and sent for laboratory analysis in order to obtain an
immediate response, which can be used by the user or by another
person. The purpose of the invention is to provide a
minimally-invasive diagnostic device for Papanicolaou testing and
to offer an alternative method to the examination that requires the
taking of a cell sample.
Inventors: |
Rovira; Noel Leon; (Nuevo
Leon, MX) ; Fuentes; Arturo Hernandez; (Coahulla,
MX) ; Escorza; Jose Antonio Viornery; (Hidalgo,
MX) ; Samaniego; Norma Frida Roffe; (Nuevo Leon,
MX) |
Correspondence
Address: |
FISH & RICHARDSON PC
P.O. BOX 1022
MINNEAPOLIS
MN
55440-1022
US
|
Assignee: |
Ave Eugenio Garza Sada #2501 Sur,
Col. Tecnologic
Nuevo Leon
MX
|
Family ID: |
39676773 |
Appl. No.: |
11/574705 |
Filed: |
February 20, 2006 |
PCT Filed: |
February 20, 2006 |
PCT NO: |
PCT/MX2006/000011 |
371 Date: |
November 27, 2007 |
Current U.S.
Class: |
600/476 ;
600/547; 600/569 |
Current CPC
Class: |
A61B 5/0059 20130101;
A61B 5/0084 20130101; A61B 5/4325 20130101; A61B 5/053 20130101;
A61B 2010/0216 20130101; A61B 5/4331 20130101 |
Class at
Publication: |
600/476 ;
600/569; 600/547 |
International
Class: |
A61B 5/053 20060101
A61B005/053; A61B 10/02 20060101 A61B010/02; A61B 6/00 20060101
A61B006/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 21, 2005 |
MX |
NL/A/2005/000016 |
Mar 1, 2005 |
MX |
NL/A/2005/000018 |
Claims
1. A portable device for detecting uterine cervical cancer by means
of simultaneous electrical and optical measurements, characterized
by comprising five parts: a) a casing inside of which it is located
the whole electronic part of the system consisting of a printed
card containing the necessary LEDs for optical measurement, as well
the photodiodes for receiving the luminous reflection from the
cells; also containing a microcontroller which sends the signals
for electrical stimulation, which is amplified by operational
amplifiers for then stimulating the cells; the microcontroller or
configurable circuit receives the signals from the diodes and
electrodes for performing an analog-to-digital conversion and
interpreting the measurements; b) a test tube containing the fiber
optics wiring needed for transmitting the light outputs and inputs;
c) a set of output and input optic fibers placed on the test tube
tip and also gold electrodes which generate current and take
measurements; d) a positioning attachment; e) a sample collecting
attachment.
2. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized in that the test tube is preferably about
4.0-7.0 mm. diameter, with four gold electrodes of 0.8-1.2 mm.
diameter, spaced each other by a middle circle of 1.5-2.0 mm.,
applying a peak to peak current between 10 .mu.A and 1 mA for an
effective measurement.
3. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized in that the fibers are sandwiched in an
epoxy resin which protects the wiring throughout the test tube, and
in the middle of a disposable cover.
4. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized in that the epoxy resin is manufactured
from a sterilizable plastics material.
5. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized in that the electronic card is connected
to one or more outer LEDs indicating the result.
6. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized in that the electronic part is a printed
card containing LEDs, photodiodes, microcontroller or configurable
circuit and operational amplifiers.
7. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized by containing a positioning attachment,
which serves as a guide for easily locating the cervix, and
consists of a circular member in the shape of a diaphragm,
including an internal concave surface, an external surface, a bore
on its center portion and a flexible plastic tube with a first end
joined to a center portion of the diaphragm shaped circular member
matching the center bore thereof.
8. The portable device for detecting uterine cervical cancer by
means of simultaneous electrical and optical measurements according
to claim 1, characterized by containing a cervix sample collecting
attachment consisting of cytological brushes which utilize, as a
guide for obtaining the samples, a positioning attachment which
serves as a guide for easily locating the cervix and consists of a
circular member in the shape of a diaphragm, including an internal
concave surface, an external surface, a bore on its center portion
and a flexible plastic tube with a first end joined to a center
portion of the diaphragm shaped circular member matching the center
bore thereof; said sample collecting attachment consisting of a
solid, rigid plastic sample collecting tube having a diameter
lesser than the rigid guide member, having a first and second end,
wherein the second end includes a plastic ring as an auxiliary grip
which allows to easily handle and rotate the sample collection
rigid tube, and preferably using three cytological scraping brushes
equidistantly joined to the first end of the rigid tube.
9. A method of controlling a portable device for performing
measurements and calculating the condition of a tissue,
characterized by outputting a current to the tissue, measuring the
voltage through the tissue, calculating the impedance and saving
the result; emitting different wavelength lights using LEDs,
measuring tissue luminescence and saving the result; calculating
the condition of the tissue based on mathematical formulae, and
lighting up a LED depending on the generated result; the readings
from the measurements are compared to mathematical formulae
programmed in the device in real time; said mathematical formulae
consider the impedance and luminance which are normally obtained
from the taken measurements; the obtained value is compared in the
central processing unit and is classified as normal (green LED) or
abnormal (yellow or red LED); in the case of the optical
measurement, three different wavelengths are output and the
luminance with which each of them returns is received; because the
size of the test tube is so reduced the transmission is done
throughout the whole test tube by means of fiber optics, these
fibers being connected to the three LEDs for outputting the signal,
whereas for performing the reading there is a photodiode also
connected to the fiber optics, then the signal is digitalized and
the comparison is made, thus subsequently sending the signal
whether normal or abnormal for displaying the final result to the
user by means of LEDs.
Description
BACKGROUND OF THE INVENTION
[0001] The identification of various kinds of tissues is based on
their response both to an electrical stimulus and the response to
light incidence. There are currently many apparatus and techniques
for identifying different kinds of tissues, both normal and tissues
infected with human papilloma virus, precancerous and cancerous.
Many optical principles exist which are already tested for
identifying tissues such as Spectroscopic Fluorescence, Raman
Spectroscopy and OCT. On other hand biological tissues have a
characteristic electrical impedance which is related to the
frequency in that the tissue has components having both resistive
and charge storing (capacitive) characteristics. Impedance
magnitude and its dependence on the frequency are a function of the
tissue composition.
[0002] The starting point of this invention focuses in the fact
that no uterine cervical cancer detection method displays a
sufficiently precise reliability, which gives a high risk of an
erroneous diagnosis, this turning into a very important matter if
we understand that this type of cancer can be cured if it detected
at an early stage, otherwise being mortal.
[0003] The conventional Papanicolau or uterine cervical cancer
testing has been practically the same since about 60 years. Since
1940 the death percentage in women having cervical cancer has
decreased 70%, mainly because many women undergo Papanicolau
testing or uterine cervical cancer tests. Although not infallible,
this test detects 95% of cervical cancers and, more importantly, it
detects them in a state which is not visible to the naked eye yet
and, therefore, they can be treated and almost invariably cured.
Despite the increase in worldwide opportune uterine cervical cancer
detection campaigns by the Papanicolau testing, in some countries,
specially those of the third world or undeveloped ones, there are
still strong cultural and psychological barriers in women and
occasionally in their couples which cause women not to undergo a
Papanicolau testing.
[0004] Among some of these barriers there are wrong beliefs, fear
to obtain an adverse result, to the pain in the examination or
shyness as the examination could be undertaken by a male person or
in the presence of strange persons in an assisting facility.
[0005] Currently there has been uncountable optical, electrical and
biomedical research, and further each one of them has different
variants. For instance the review article "Relation between tissue
structure and imposed electrical current flow in cervical
neoplasia" relates to studies performed on the cervix tissue
reaction when electrical pulses are applied at different frequency
ranges. This article discloses a thorough research of every part
intervening in this invention, particularly on the electrical
measurement, optical measurement, the electronics inside the device
and the assembly materials.
[0006] Inventions currently exist that use electrical impedance
measurement from tissue. Representative patents are: U.S. Pat. No.
4,458,694, "Apparatus and method for detection of tumors in
tissue"; U.S. Pat. No. 5,353,802, "Device for measurement of
electrical impedance of organic and biological materials"; U.S.
Pat. No. 5,361,762, "Apparatus for detecting properties,
differences and changes of humans or animals bodies"; and U.S. Pat.
No. 6,026,323, "Tissue diagnostic system". In relation to the
optical part based on the methods of light reflection from tissues
the representative patents are the following: U.S. Pat. No.
4,930,516, "Method for detecting cancerous tissue using visible
native luminescence"; U.S. Pat. No. 5,503,853, "Use of light
conveyed by fiber optics to locate tumors. Physiological probe";
U.S. Pat. No. 5,439,000, "Method of diagnostic tissue with
guidewire", and U.S. Pat. No. 6,026,323, "Tissue diagnostic
system".
[0007] With respect to self-detection devices, some important
inventions have been found. U.S. Pat. No. 3,995,618 to Kingsley et
al. claims a cervical sample collecting device which can be
self-administered comprising an outer tube and an inner tube
telescopically positioned inside the outer tube, a wet cervical
sponge having a setting solution and mounted in the front end
portion of the inner tube and projecting outwardly from it and a
protecting sleeve which surrounds the inner tube and the cervical
sponge before and after its insertion into the vagina.
[0008] U.S. Pat. No. 5,231,992 claims a device for self-obtaining
cervix cell and fluid samples comprising a cervical cell and fluid
collector, formed of a disc shaped body manufactured from a
polyurethane foam which is placed in the patient's cervix and
fluids and cells adhere to the device walls.
[0009] U.S. Pat. No. 6,155,990 to Fournier claims a device for
auto-sampling culture material or specimens used in cytological or
microbiological study techniques, which comprises a cardboard tube
housing a retractable sponge that includes a grip adapted for
serving as a screwable cap for sealing and preserving a sample
within a tube.
[0010] U.S. Pat. No. 6,302,853 to Sak, Robert F. claims a device
and method for collecting cervical tissue samples comprising an
insertion tube and an introduction guide member which guides the
insertion tube into the vaginal cavity. A cervical sample collector
is included that is positioned inside the vaginal insertion tube
and extends into the vaginal cavity for collecting the sample,
which has to be rotated until completing a revolution.
[0011] U.S. Pat. No. 6,402,700 to Richards, claims an personal
apparatus and method for taking cervical cell samples that includes
an insertion handle, a flexible speculum ring and means for movably
attaching the speculum ring to the insertion handle. The speculum
ring includes two adjacent ring halves circumferentially divided in
order to allow the expansion of the speculum tube housed inside the
hollow ring halves. The method comprises inserting the flexible
speculum assembly inside user's vagina, moving the speculum ring
into a raised position surrounding the cervix, separating the ring
halves for expanding the tube, defining an speculum aperture and
inserting a sampling tool through the orifice until it contacts the
cervix or the surface of the areas adjacent thereto.
[0012] Australian Patent No. A61B 10/00 discloses a device for
cervical tissue sample collection comprising a cylindrical barrel
with an inner shaft. Said shaft has in its one end a circular brush
and a sponge. The device is introduced in the vagina, and once it
is inside the shaft is pushed and the end is rotated. The sponge
and brush will collect a sample of the tissues. Once the process
has ended, the shaft end wherein the brush and sponge are located
can be detached and sent to analysis.
[0013] British Patent No. GB 2159240 teaches a method for obtaining
cervical canal cells by inserting a conical shaped brush for
trapping the cells therein.
[0014] The main disadvantage of these devices claimed by all the
above disclosed patents resides in the fact that the user cannot
achieve a correct localization of the cervix, therefore the sample
is taken from wrong places consequently obtaining very poor quality
samples which are inadequate for their analysis, thus causing the
need of repeating the test or that the user has to attend an
specialist.
[0015] From the above disclosure, a need has been found for having
a device which relies in the correct positioning and locating of
the cervix and that also does not always uses an invasive method
based on the retrieval and sample collection of the cervix, and
that this new device by means of an accurate localization of the
cervix performs simultaneous electrical and optical tissue
measurements, and in the case of the test resulting positive to
cancer this same device by means of an attachment retrieves the
tissue samples in order for them to be sent to a laboratory and
follow the common procedure. Other advantage of this invention is
that the user has the choice of performing the detection test
without requiring the presence of a skilled physician.
BRIEF DISCLOSURE OF THE DRAWINGS
[0016] The drawings herein attached are briefly disclosed in the
following.
[0017] FIG. 1 shows an schematic view of the present invention
apparatus.
[0018] FIG. 2 shows a side view of the test piece used in the
present invention.
[0019] FIG. 3 depicts an isometric cross-section view of the casing
or handle used in the present invention.
[0020] FIG. 4 depicts a cross-section view of the casing or handle
used in the present invention.
[0021] FIG. 5 shows a view of the test tube making contact with the
cervix in the present invention.
[0022] FIG. 6 is an schematic view of the assembled positioning
attachment.
[0023] FIG. 7 is a top view of the positioning attachment.
[0024] FIG. 8 is an schematic view of the sample collecting
attachment.
[0025] FIG. 9 is a block diagram showing the operation of the
present invention device.
[0026] FIG. 10 is a flowchart showing the operation of the
device.
DISCLOSURE OF THE INVENTION
[0027] The invention presented in this document is a novel system
designed for detecting cancer, precancer and human papilloma
virus.
[0028] The device is a portable uterine cervical cancer detection
optoelectronic system. It is an instrument manipulated by the
physician or its user and displays a real time result, being
optional the collection of physical tissue samples for testing. In
its outer part the present invention consists of three main
components, being the first one the casing (1) inside of which it
is located the whole electronic part of the system which rests on a
printed card containing the necessary LEDs for optical measurement,
as well the photodiodes for receiving the luminous reflection from
the cells; the printed card also contains a microcontroller or
configurable device that has several functions, on of them being
the sending of signals amplified by operational amplifiers for the
electrical stimulation of the cells; an interface receiving the
signals from the diodes and electrodes for performing an
analog-to-digital conversion and sending them to the
microcontroller or configurable device in order for it to read the
collected measurements to give a response which will be instantly
displayed in light indicators; the second part is the test tube (2)
through which the fiber optics wiring (4) pass that are needed for
transmitting the light outputs and inputs; on other hand there is
the test tube tip (3) in which the output (10) and input (11) fiber
optics are located, also the gold electrodes which generate the
current and perform electrical measurements (9). The fibers are
sandwiched in an epoxy resin (12) which protects the wiring
throughout the test tube manufactured from a sterilizable plastics
material preferably Ultem (8). Outside the test tube a disposable
cover (13) is disposed for the hygienic reutilization of the
device.
[0029] The positioning attachment consists of a circular member
(14) of flexible medical grade plastic in the shape of a diaphragm,
including an internal concave surface (15), an external surface
(16), a bore (17) on its center portion and a circular ring (18) of
the same material depending on its periphery. It also contains a
flexible guide member comprising a flexible plastic tube (19) with
a diameter similar to that of the center bore (17) of the diaphragm
shaped circular member (14), having a first end (20) joined to the
center portion of the positioning member, matching the center bore
thereof and depending from its outer surface, and a second end
(21). Finally, it has a rigid, hollow guide member (22) with a
diameter lesser than the flexible plastic tube (19) of the
positioning member, having first and second ends and a plastic ring
(23) joined to its second end (21).
[0030] The sample collecting attachment, shown in FIG. 8, consists
of a sample collection solid rigid plastic tube (24) having a
diameter lesser than the rigid guide member, having a first (25)
and second (26) end, wherein the second end includes a plastic ring
(27) joined to the second end (26) as an auxiliary grip which
allows to easily handle and rotate the sample collection rigid
tube, and three cytological scraping brushes (28) equidistantly
joined to the first end of the rigid tube at an angle of about 15
grades to a vertical reference axis of the rigid tube.
[0031] The user begins the testing for uterine cervical cancer
detection by means of the control panel (29) which performs the
general turning on and off functions. The operation of the device
actuates the electrical and optical stimulation by sending the
corresponding signals and performing the measurements. Signal
sending and processing of the measurement data retrieved in the
different measurements are performed in an electronic card (6)
which contains the processing unit implemented by a microcontroller
or configurable circuit. This processing unit sends the optical
signals through the light emitting circuit (35) and the electrical
signals through the current injection circuit (37). The central
processing unit receives the resulting luminance through the light
receiving circuit (36), and the voltage present in the tissue
through the voltage measuring circuit (38) and stores them in the
storage system (34). With the measurements captured from the
signals received by these data, the condition of the tissue is
calculated and the result is delivered in real time by the three
outer LEDs (7 and 32) (wherein a green LED indicates that the
person is healthy, a yellow LED indicates the presence of human
papilloma virus, and a red LED indicating the presence of cancerous
cells). In FIG. 9 the device block diagram can be observed, which
apart from the aforementioned components, shows the test tube (31)
and positioning attachment (33).
[0032] FIG. 10 depicts a flowchart explaining the device operation.
As seen in the chart, the cancer detection process is automated and
executed in real time, thus providing instant results, which is
very convenient for self-detection.
[0033] The physician or user performing the testing passes the tip
of the test tube through the cervix where the measurements are done
by using electrical pulses at different frequencies, as well as
light pulses in three different wavelengths.
[0034] The readings obtained from the measurements are processed in
the microcontroller or configurable device according to
mathematical formulae, which were designed from tests performed on
healthy and cancerous tissue in order for the detection to be
possible. The processing outcome is the classification of the
measurements as normal (green LED) or abnormal (yellow or red LED).
When an abnormality is found on a sample there are two possible
causes and actions: Presence of human papilloma virus (yellow LED
lights up), presence of cancer cells (red LED lights up).
[0035] This invention provides as main feature that it is an
instrument capable of taking two simultaneous measurements, the
electrical and the optical ones, from very small tissue sections,
in that currently there are no evidences that the tests are
affected each other.
[0036] Moreover, the device posses an attachment that can be used
for performing a self-detection, that is, the person itself can
perform the cervical cancer test without needing help from other
person, and thus the above explained differs from all the up to now
patented devices such as the one entitled "Hybrid probe for tissue
type recognition", that entitled "Apparatus for tissue type
recognition within a body canal", that entitled "Integral sheathing
apparatus for tissue recognition probes", and that entitled "Tissue
diagnostic system".
[0037] The invention consists of the sequence of tests performed by
the two electrical and optical measurement methods; in order for
the tests to be adequately performed the tip of the test tube needs
to contact the patient cervix, it is important that the measurement
is taken through the whole cervix in order to have a significant
measurement of all the tissues.
[0038] In the case of the electrical part, the current is applied
to the surface and the same does not necessarily expands through
the surface of the tissue but it penetrates therein to a certain
depth. The features of the electrical impedance of the tissues can
be explained by changes in cell arrangements and the size of the
nucleus. This relation constitutes the basis for knowing the tissue
structure starting from the electrical impedance spectrum
measurements, that is to say, this pattern will serve us to
differentiate normal tissues from precancerous ones. The main
changes in precancerous tissue occur by the subdivision in the
surface cell layers and there also occurs an increase in the
nucleus size. The proposed method is performed with a test tube of
about 4.0-7.0 mm. diameter, with four gold electrodes of 0.8-1.2
mm. diameter, spaced each other by a middle circle of 1.5-2.0 mm.,
applying a 10 .mu.A peak to peak current at several frequencies.
The condition of the tissue is related to the frequency in that the
tissue has components having both resistive and charge storage
(capacitive) characteristics. The magnitude of the impedance and
its dependence on the frequency are a function of the tissue
composition. The measurement is performed with the same electrodes
located in the test tube.
[0039] In the case of the optical part, three different wavelengths
are output and the luminance with which each of them returns is
received. Because the size of the test tube is so reduced the
transmission is done throughout the whole test tube by means of
fiber optics, these fibers being connected to the three. LEDs for
outputting the signal, whereas for performing the reading there is
a photodiode also connected to the fiber optics, then the signal is
digitalized and the comparison is made, thus subsequently sending
the signal whether normal or abnormal for displaying the final
result to the user by means of three LEDs.
[0040] The best method for both measurements to be successfully
performed requires a series of steps which will now be disclosed
briefly and in order: Placing the tip of the test tube on the
cervix and performing a scanning or sweep therethrough; performing
the electrical stimulation and sending the optic pulses; receiving
the measurement of impedance value and light intensities,
digitizing the signal; processing the measurements by comparing
them to values previously obtained and synthesized in a
mathematical formula and obtaining an instant response. It is
advisable to make a scanning on the cervix from between one and two
minutes in order to obtain a reliable measurement.
* * * * *