U.S. patent application number 12/287801 was filed with the patent office on 2009-04-16 for method and device for the optical spectroscopic identification of cervical cancer.
This patent application is currently assigned to Remicalm LLC. Invention is credited to Andres Felipe Zuluaga.
Application Number | 20090099460 12/287801 |
Document ID | / |
Family ID | 40534897 |
Filed Date | 2009-04-16 |
United States Patent
Application |
20090099460 |
Kind Code |
A1 |
Zuluaga; Andres Felipe |
April 16, 2009 |
Method and device for the optical spectroscopic identification of
cervical cancer
Abstract
A medical examination device used for the detection of
pre-cancerous and cancerous tissue has an illumination source, a
visualization unit, a contacting optical probe, a detector and a
process unit. One embodiment of the apparatus includes both a
non-contacting macroscopic viewing device (the visualization unit)
for visualizing an interior surface of the cervix, as well as a
fiber optic wand (contacting optical probe) for spectrally
analyzing a microscopic view of the tissue.
Inventors: |
Zuluaga; Andres Felipe;
(Houston, TX) |
Correspondence
Address: |
ELIZABETH R. HALL
1722 MARYLAND STREET
HOUSTON
TX
77006
US
|
Assignee: |
Remicalm LLC
Houston
TX
|
Family ID: |
40534897 |
Appl. No.: |
12/287801 |
Filed: |
October 14, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12229541 |
Aug 25, 2008 |
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12287801 |
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60999095 |
Oct 16, 2007 |
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Current U.S.
Class: |
600/478 |
Current CPC
Class: |
A61B 1/00186 20130101;
A61B 1/0646 20130101; A61B 5/0071 20130101; A61B 5/0084 20130101;
A61B 1/043 20130101; A61B 1/303 20130101; A61B 1/042 20130101; A61B
2560/0437 20130101; A61B 1/00039 20130101; A61B 5/0075
20130101 |
Class at
Publication: |
600/478 |
International
Class: |
A61B 6/00 20060101
A61B006/00 |
Claims
1. A medical examination device comprising: an illumination source,
wherein the illumination source includes a lamp and a plurality of
selectably engageable filters for generating a beam of light of a
selected wavelength; a light directing device for selectably
directing the beam of light from the lamp in a first beam direction
or in a second beam direction; a visualization unit that receives
the beam of light whenever the beam of light is directed in the
first beam direction and radiates a tissue with the received beam
of light, the visualization unit visualizes and captures a
macroscopic view of the tissue from a first emitted light beam
emanating from the tissue illuminated with the received beam of
light; a fiber optic probe having a shaft, a handle, and a fiber
optic bundle having a plurality of excitation fiber optic strands
and a collection fiber optic strand, wherein whenever the beam of
light is directed in the second beam direction the excitation fiber
optic strands receive and transmit the beam of light to a selected
microscopic tissue area at a site of contact with a distal end of
the fiber optic probe, and wherein the collection fiber optic
strand collects a second emitted light beam emanating from the
tissue area illuminated with the beam of light transmitted by the
excitation fiber optic strands; a detector for detecting a
plurality of emission wavelengths from the second emitted light
beam; and a processor for calculating from the emission wavelengths
a probability that the tissue is diseased.
2. The medical examination device of claim 1, wherein the plurality
of filters are in a filter wheel.
3. The medical examination device of claim 1, wherein the lamp
includes a plurality of selectable LEDs.
4. The medical examination device of claim 1, wherein the light
directing device includes a mirror that is reciprocable between a
first mirror position and a second mirror position.
5. The medical examination device of claim 1, wherein the light
directing device includes a beam splitter.
6. The medical examination device of claim 1, wherein the
visualization unit includes an ocular device for visualizing the
macroscopic view of the tissue.
7. The medical examination device of claim 1, wherein the
visualization unit includes a camera for capturing the macroscopic
view of the tissue.
8. The medical examination device of claim 1, wherein the distal
end of the probe is a blunted surface for optimizing contact with
the tissue.
9. The medical examination device of claim 1, wherein the
collection fiber optic strand is centrally positioned in the fiber
optic bundle and is surrounded by multiple coaxial excitation fiber
optic strands.
10. The medical examination device of claim 1, wherein the fiber
optic probe further comprising a disposable sheath for covering the
shaft of the fiber optic probe.
11. The medical examination device of claim 1, wherein the lamp is
a plurality of selectable LEDs, a Xenon arc lamp, a Mercury arc
lamp or a halogen lamp.
12. The medical examination device of claim 1, wherein the beam of
light used to illuminate the tissue for fluorescence excitation has
a wavelength band of about 455-465 nm, 410-430 nm, 375-385 nm, or
340-360 nm.
13. The medical examination device of claim 1, wherein the beam of
light used to illuminate the tissue for reflectance visualization
has a wavelength band of about 400-700 nm, 455-465 nm, or 410-430
nm.
14. The medical examination device of claim 13, wherein the beam of
light is polarized or unpolarized.
15. A medical examination device comprising: an illumination
source, wherein the illumination source includes a lamp and a
plurality of selectably engageable filters for generating a beam of
light of a selected wavelength; a light directing device for
selectably directing the beam of light from the lamp in a first
beam direction or in a second beam direction; a visualization unit
that receives the beam of light whenever the beam of light is
directed in the first beam direction and radiates a tissue with the
received beam of light, the visualization unit captures an image of
a macroscopic view of the tissue from a first emitted light beam
emanating from the tissue illuminated with the received beam of
light; a fiber optic probe having a shaft, a handle, and a fiber
optic bundle having a plurality of excitation fiber optic strands
and a collection fiber optic strand, wherein whenever the beam of
light is directed in the second beam direction the excitation fiber
optic strands receive and transmit the beam of light to a selected
microscopic tissue area at a site of contact with a distal end of
the fiber optic probe, and wherein the collection fiber optic
strand collects a second emitted light beam emanating from the
tissue area illuminated with the beam of light transmitted by the
excitation fiber optic strands; a detector for detecting a
plurality of emission wavelengths from the second emitted light
beam; a user interface unit; and a processor in communication with
the illumination source, the light directing device, the
visualization unit, the fiber optic probe, the detector and the
user interface unit.
16. The medical examination device of claim 15, wherein the user
interface unit informs the processor to selectably activate the
visualization unit or the fiber optic probe.
17. The medical examination device of claim 16, wherein the
processor activates the light directing device to selectably direct
the beam of light in the first beam direction or in the second beam
direction.
18. The medical examination device of claim 15, wherein the user
interface unit informs the processor to select and engage one of
the filters in the illumination source.
19. The medical examination device of claim 15, wherein the
visualization unit includes a camera for capturing the macroscopic
view of the tissue.
20. The medical examination device of claim 15, wherein the
visualization unit captures a first set of images including one
image of the macroscopic view of the tissue for each wavelength of
a first set of selected wavelengths.
21. The medical examination device of claim 20, wherein the first
set of captured images is displayed on a monitor.
22. The medical examination device of claim 15, wherein the fiber
optic probe further comprises a disposable sheath for covering the
shaft of the fiber optic probe.
23. The medical examination device of claim 22, wherein the distal
end of the fiber optic probe and the distal end of the sheath is
blunted to provide close contact with the microscopic tissue
area.
24. The medical examination device of claim 15, wherein the fiber
optic probe sequentially transmits a beam of light to the selected
microscopic tissue area for each wavelength of a second set of
selected wavelengths.
25. The medical examination device of claim 24, wherein the
collection strand of the fiber optic probe collects the second
emitted light beam for each wavelength of the second set of
wavelengths.
26. The medical examination device of claim 25, wherein the
processor calculates a probability that the microscopic tissue area
is diseased from the emission wavelengths detected by the detector
in second emitted light beams collected for the second set of
wavelengths.
27. The medical examination device of claim 15, wherein the
processor calculates from the emission wavelengths of the second
emitted light beam a probability that the microscopic tissue area
is cancerous.
28. The medical examination device of claim 15, wherein the
detector includes a spectrophotometer and a plurality of selectably
engageable filters for filtering the second emitted light beam
before the second emitted light beam enters the detector.
29. A method of detecting cervical cancer comprising the steps of:
filtering a beam of light from an illumination source with a
selection of filters to produce a plurality of desired wavelengths;
sequentially transmitting a first set of wavelengths produced from
the beam of light to a visualization unit; illuminating a portion
of a cervix with the first set of wavelengths transmitted to the
visualization unit; capturing an image of a macroscopic view of the
cervix illuminated with each of the first set of wavelengths;
selecting a microscopic tissue site within the macroscopic view for
further investigation; watching the placement of a distal end of a
fiber optic probe in contact with the selected microscopic tissue
site; activating a light directing device to direct a second set of
wavelengths to a plurality of excitation fibers in the fiber optic
probe; sequentially transmitting the second set of wavelengths
though the excitation fibers to illuminate the selected tissue
site; collecting an emitted light beam emanating from the
illuminated tissue site through a reception fiber optic strand;
conducting a spectral analysis of the collected light using a
spectrometer; and calculating a probability that the selected
tissue site is cancerous.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation-in-part
application of U.S. patent application Ser. No. 12/229,541 filed
Aug. 25, 2008 and entitled "Optical Spectroscopic Device for the
Identification of Cervical Cancer" and, pursuant to 35 U.S.C.
111(b), claims the benefit of the earlier filing date of
provisional application Ser. No. 60/999,095 filed Oct. 16, 2007,
and entitled "Apparatus for Optical Spectroscopic Identification of
Cancer in Clinical Use."
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to a medical device for use in a
clinical environment that utilizes optical spectroscopic means for
the identification of cervical pre-cancerous and cancerous
conditions. More particularly, the present invention relates to a
medical examination apparatus having an illumination source, an
optical probe, a visualization unit, a detector, and a processing
unit for identifying pre-cancerous and cancerous conditions.
[0004] 2. Description of the Related Art
[0005] Cervical cancer is the second most common malignancy in
women worldwide. The mortality associated with cervical cancer can
be reduced if this disease is detected at the early stages of
development or at the pre-cancerous state. A pap smear is used to
screen the general female population for cervical cancer with more
than 70 million performed each year in the United States. In spite
of its broad acceptance as a screening test for cervical cancer,
pap smears probably fail to detect 50-80% Of low grade cancerous
lesions and about 15-30% of high grade lesions.
[0006] While the pap smear is designed for initial screening,
colposcopy and related procedures are typically used to confirm pap
smear abnormalities and to grade cancerous and potential cancerous
lesions. Although it is generally recognized that colposcopy is
highly effective in evaluating patients with abnormal pap smears,
colposcopy has its own limitations. Conventional colposcopy is a
subjective assessment based on the visual observation of the
clinician and the quality of the results depends greatly on the
expertise of the practitioner.
[0007] Commercially available colposcopes are large free-standing
instruments and are generally maintained in a single location
(i.e., one examination room). Furthermore, colposcopes are
expensive and are typically shared by multiple doctors.
Accordingly, when a colposcopic examination is required, the
patient has to be brought to the colposcope. Based on the limited
availability of the colposcope, a special appointment time separate
from the initial appointment is usually required resulting in
additional time and cost to a patient as well as delayed
examinations.
[0008] Accordingly, a portable apparatus, which allows for a
close-up visual medical examination would be advantageous for
providing an examination without relocation of the patient or
providing a separate appointment time. Such an apparatus should be
readily useable and economical, thereby making diagnosis and
treatment more readily available and cost efficient.
SUMMARY OF THE INVENTION
[0009] One embodiment of the invention provides a medical
examination device used for the detection of pre-cancerous and
cancerous tissue having an illumination source, a visualization
unit, a contacting optical probe, a detector and a process unit. A
preferred embodiment of the apparatus includes both a
non-contacting macroscopic viewing device (the visualization unit)
for visualizing the cervix, as well as a fiber optic wand
(contacting optical probe) for spectrally analyzing a microscopic
view of the tissue.
[0010] Another embodiment of the invention is a medical examination
device comprising: A medical examination device comprising: an
illumination source, wherein the illumination source includes a
lamp and a plurality of selectably engageable filters for
generating a beam of light of a selected wavelength; a light
directing device for selectably directing the beam of light from
the lamp in a first beam direction or in a second beam direction; a
visualization unit that receives the beam of light whenever the
beam of light is directed in the first beam direction and radiates
a tissue with the received beam of light, the visualization unit
visualizes and captures a macroscopic view of the tissue from a
first emitted light beam emanating from the tissue illuminated with
the received beam of light; a fiber optic probe having a shaft, a
handle, and a fiber optic bundle having a plurality of excitation
fiber optic strands and a collection fiber optic strand, wherein
whenever the beam of light is directed in the second beam direction
the excitation fiber optic strands receive and transmit the beam of
light to a selected microscopic tissue area at a site of contact
with a distal end of the fiber optic probe, and wherein the
collection fiber optic strand collects a second emitted light beam
emanating from the tissue area illuminated with the beam of light
transmitted by the excitation fiber optic strands; a detector for
detecting a plurality of emission wavelengths from the second
emitted light beam; and a processor for calculating from the
emission wavelengths a probability that the tissue is diseased.
[0011] Yet another embodiment of the present invention is a medical
examination device comprising: an illumination source, wherein the
illumination source includes a lamp and a plurality of selectably
engageable filters for generating a beam of light of a selected
wavelength; a light directing device for selectably directing the
beam of light from the lamp in a first beam direction or in a
second beam direction; a visualization unit that receives the beam
of light whenever the beam of light is directed in the first beam
direction and radiates a tissue with the received beam of light,
the visualization unit captures an image of a macroscopic view of
the tissue from a first emitted light beam emanating from the
tissue illuminated with the received beam of light; a fiber optic
probe having a shaft, a handle, and a fiber optic bundle having a
plurality of excitation fiber optic strands and a collection fiber
optic strand, wherein whenever the beam of light is directed in the
second beam direction the excitation fiber optic strands receive
and transmit the beam of light to a selected microscopic tissue
area at a site of contact with a distal end of the fiber optic
probe, and wherein the collection fiber optic strand collects a
second emitted light beam emanating from the tissue area
illuminated with the beam of light transmitted by the excitation
fiber optic strands; a detector for detecting a plurality of
emission wavelengths from the second emitted light beam; a user
interface unit; and a processor in bi-directional communication
with the illumination source, the light directing device, the
visualization unit, the fiber optic probe, the detector and the
user interface unit.
[0012] Still yet another embodiment of the present invention is a
method of detecting cervical cancer comprising the steps of:
filtering a beam of light from an illumination source with a
selection of filters to produce a plurality of desired wavelengths;
sequentially transmitting a first set of wavelengths produced from
the beam of light to a visualization unit; illuminating a portion
of a cervix with the first set of wavelengths transmitted to the
visualization unit; capturing an image of a macroscopic view of the
cervix illuminated with each of the first set of wavelengths;
selecting a microscopic tissue site within the macroscopic view for
further investigation; watching the placement of a distal end of a
fiber optic probe in contact with the selected microscopic tissue
site; activating a light directing device to direct a second set of
wavelengths to a plurality of excitation fibers in the fiber optic
probe; sequentially transmitting the second set of wavelengths
though the excitation fibers to illuminate the selected tissue
site; collecting an emitted light beam emanating from the
illuminated tissue site through a reception fiber optic strand;
conducting a spectral analysis of the collected light using a
spectrometer; and calculating a probability that the selected
tissue site is cancerous.
[0013] The foregoing has outlined rather broadly several
embodiments of the present invention in order that the detailed
description of the invention that follows may be better understood.
Additional features and advantages of the invention will be
described hereinafter which form the subject of the claims of the
invention. It should be appreciated by those skilled in the art
that the conception and the specific embodiment disclosed might be
readily utilized as a basis for modifying or redesigning the
structures for carrying out the same purposes as the invention. It
should be realized by those skilled in the art that such equivalent
constructions do not depart from the spirit and scope of the
invention as set forth in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] For a more complete understanding of the present invention,
and the advantages thereof, reference is now made to the following
descriptions taken in conjunction with the accompanying drawings,
in which:
[0015] FIG. 1 is a schematic view illustrating the basic components
of the medical examination device and their interrelationship.
[0016] FIG. 2 is a schematic view showing the interrelationship of
the components in one embodiment of the device.
[0017] FIG. 3 is a schematic view showing the interrelationship of
the components of one embodiment of the visualization unit.
[0018] FIG. 4 is a schematic view showing the interrelationship of
the excitation and collection fiber optic strands in one embodiment
of the fiber optic bundle that traverses the optical probe.
[0019] FIG. 5 is an oblique view of the wand from its side on which
the on/off switch is mounted, showing the wand with its disposable
sheath removed.
[0020] FIG. 6 is a view corresponding to FIG. 6, but with the
disposable sheath in position for contact with a patient.
[0021] FIG. 7 is a schematic view showing the interrelationship of
the computer/control and the power supply with the basic components
of the medical examination device.
[0022] FIG. 8 is a schematic view illustrating the interaction of
general components of the device and several optional
accessories.
[0023] FIG. 9 is an oblique frontal view of the first embodiment of
the device.
[0024] FIG. 10 is an oblique rear view of the device of FIG. 1.
[0025] FIG. 11 shows an oblique view of a second embodiment of the
medical examination device while in use.
[0026] FIG. 12 is a side profile view of the device of FIG. 11 in
its stowed position.
[0027] FIG. 13 is a rear view of the stowed device of FIG. 11.
[0028] FIG. 14 is a frontal view of the user interface of the
device when the visualization unit has been selected for use.
[0029] FIG. 15 is a frontal view of the user interface of the
device when the optical probe has been selected for use.
[0030] FIG. 16 is a list of names given one example of a set of six
different wavelengths of light used to illuminate the cervix.
[0031] FIG. 17 is a frontal view of a monitor displaying a set of
six images of macroscopic views of the cervix illuminated at
different wavelengths of light.
[0032] FIG. 18 is a view of the external monitor display when the
operator has selected the "View" mode of operation when the
visualization unit has been selected for use.
[0033] FIG. 19 shows the external monitor display of Wand Results
for a set of tissue sites spectrally analyzed using the wand.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] The present invention relates to an apparatus and method for
obtaining diagnostic evaluations of potential precancerous tissues
and cancerous tumors on externally exposed body surfaces.
Specifically, the apparatus is suitable for the identification of
skin cancers, oral cancers and cervical cancers. The configuration
of the apparatus may be specifically arranged depending on the
anatomical location of the potential cancer. By way of example, a
preferred embodiment of the apparatus for the diagnosis of cervical
cancer includes both a non-contacting colposcope (a macroscopic
visualization unit) and a contacting fiber optic wand (a
microscopic spectral analysis unit).
[0035] A colposcope is a device that provides a magnified view of
an illuminated area of the cervix, the vagina or the vulva. Cancer
and precancerous conditions are usually indicated by the differing
appearance of tissues, including for example the presence of
abnormal vessels and whitening after application of acetic acid.
Cancer is also indicated by different fluorescence than that of
normal tissue.
[0036] As illustrated in FIG. 1, the medical examination device has
an illumination source 100, a visualization unit 200, an optical
probe or fiber optic wand 300, a detector 400, a processing unit
500, and a power supply 600. These basic components may be
implemented in a variety of embodiments and can be packaged in a
number of configurations without departing from the scope of the
invention as set forth in the claims.
[0037] I. Basic Components of the Medical Examination Device
[0038] The Illumination Source
[0039] One of the basic components of the medical examination
device is the illumination source 100. The illumination source
includes a lamp 105, an emergency shutter 102, optional filters and
a light directing device.
[0040] One embodiment of the lamp 105 is a Xenon or Mercury arc
lamp, while other embodiments include LEDs (light emitting diodes),
a Helium Cadmium laser, a halogen lamp, and the like. For example,
one embodiment uses a plurality of selectable LEDs. Since LEDs are
available that emit a variety of colors or emitted wavelength
bands, the use of one or more LEDs can be used to provide the
desired wavelength band of the light beam emitted.
[0041] The generated light is typically transmitted via a liquid
light guide and/or fiber optic cable. The schematic representation
of the examination device shown in FIG. 2 illustrates the light
generated from lamp 105 transmitted via a liquid light guide 104
through an emergency shutter 102 that can be used to shut off all
of the light being transmitted to the tissue in case of an
emergency.
[0042] The illumination source also includes a light directing
device that directs the light to either the visualization unit 200
or the optical probe 300. The medical examination device uses the
same illumination source to provide the light beam for the
visualization unit 200 or the optical probe 300. The light
directing device selectably uses the illumination source for either
the visualization unit 200 or the optical probe 300. An advantage
of using a single illumination source for both the visualization
unit 200 and the optical probe 300 is that the light beam from the
light source can be selectably conditioned or filtered at one
location before the beam is directed to the visualization unit 200
or the optical probe 300.
[0043] A preferred embodiment of the light directing device can
reciprocably direct the emitted light beam in either a first
direction to the visualization unit 200 or in a second direction to
the optical probe 300. For example, one such embodiment of the
light directing device is illustrated in FIG. 2. This light
directing device includes a mirror 120 that is rotatable between a
1.sup.st mirror position 122 and a 2.sup.nd mirror position
124.
[0044] The mirror 120 is biased into the 1.sup.st mirror position
122. The 1.sup.st mirror position 122 is up and allows the light
beam to continue in a forward horizontal direction to enter the
excitation fibers 310 of the wand fiber bundle 302. The mirror 120
is moved into the 2.sup.nd mirror position 124 whenever the
solenoid 130 is selectably actuated. The 2.sup.nd mirror position
124 reflects the light upward to the mirror 210 in the
visualization unit 200 which then reflects the light beam 97 to the
tissue 99 for assessment by the visualization unit 200. One
advantage of using the reciprocable mirror as the light directing
device is that a greater percentage of the light intensity is
delivered to the tissue than when the light is directed using a
beam splitter or dichroic mirror.
[0045] An alternative embodiment of the light directing device is
shown in FIG. 3. Light from the lamp 105 is transmitted through a
fiber optic cable 66 through a lens 64 and/or an excitation filter
65 and into a beam splitter and/or dichroic mirror 122. The beam
splitter and/or a dichroic mirror 122 selectably diverts the light
into a first forwardly extending horizontal path 97 to the tissue
99 for use in the macroscopic visualization unit 200 or into a
second forwardly extending horizontal path 95 for use by the fiber
optic wand 300.
[0046] Commonly the generated light is conditioned and/or filtered
with optical lenses and filters to obtain the desired wavelength
band for the light beam used for the medical examination. The light
is optionally conditioned or filtered using either one or more
selected lenses or filters, or one or more actuated filter wheels
containing a number of filters. If the light beam is to be
conditioned using a lens and/or a filter, the lens or filter is
typically positioned between the lamp 105 emitting the light beam
and the light directing device.
[0047] The embodiment illustrated in FIG. 2 uses both a motor
actuated conditioning filter wheel 110 and a motor actuated
excitation filter wheel 112 to prepare the light used to illuminate
the tissue 99. These filter wheels may contain any number of
filters and/or lenses, such as a polarizer or neutral density
filter or fluorescent filter. Alternatively, the light may be
conditioned or filtered using one or more individual lenses or
filters, such as lens 64 and filter 65 illustrated in FIG. 3.
[0048] Fluorescent and/or reflectance spectra are typically used to
characterize the pre-cancerous or cancerous condition of the tissue
being examined. One or more excitation fluorescence bandwidths may
be used, such as 455-465 nm, 410-430 nm, 375-385 nm and/or 340-360
nm, to excite the tissue. Similarly if reflectance is used to
examine the tissue, then white light (400-700 nm), or narrower
bands such as 455-465 nm, 410-430 nm or 550-590 nm may be used to
illuminate the tissue. Parallel and/or cross-polarized light may
also be used to enhance different tissue structures.
[0049] The Visualization Unit
[0050] The visualization unit 200 provides a wide field macroscopic
view of the tissue 99. The visualization unit 200 is a
non-contacting viewer of the tissue 99 and includes an ocular
viewer, like a colposcope, and is referred to herein as the
colposcope mode. The visualization unit 200 may optionally include
a camera 230. Preferred embodiments will typically include a
binocular viewer 250 and an electronic digital camera 230 for
displaying, capturing and storing reflectance and fluorescence
images of the illuminated tissue 99.
[0051] One embodiment of the visualization unit 200 shown in FIG. 2
directs a light beam 97 to the tissue sample 99. The beam of light
98 resulting from the light beam 97 impinging on the tissue sample
99 is optionally filtered or conditioned before being directed to a
binocular viewer 250 or to a camera 230 for recording. The
embodiment illustrated in FIG. 2 uses a motor actuated filter wheel
220 to filter or condition the beam of light 98 before sending it
through a beam splitter 128 that splits the light beam 98 so that
the image of the tissue can be seen through both the binocular
viewer 250 and the camera 230. Alternatively, a light directing
device that directs the light beam 98 to either the binocular
viewer 98 or the camera 230 may also be used.
[0052] The nature of the light beam 98 will depend on the nature of
the impinging light beam 97. For example, if the light beam 97 is
white light, then the returning light beam 98 is reflected light.
Alternatively, if the light beam 97 is fluorescent light that
impinges on the surface of the tissue 99 causing it to fluoresce,
then the light beam 98 will be the resultant fluorescence from the
tissue 99.
[0053] A second embodiment of the visualization unit 200 is
illustrated in FIG. 3. The fluorescence or reflected light from the
tissue 99 is returned in a beam 98 to the visualization unit 200.
This embodiment of the visualization unit 200 passes the light beam
98 through a beam splitter 128, and then optionally conditions or
filters the beam 98 using one or more preselected lenses or
filters. For example, the beam splitter 128 is shown splitting the
light beam 98 through a lens/filter 127 to be visually displayed to
a monocular device 240 and through a lens/filter 123 to be
photographed by a camera 230.
[0054] Alternatively, the same location on the sample may be viewed
simultaneously through the ocular viewer 240 and the camera 230 by
removing the beam splitter 128 and independently adjusting the
optics of the camera 230 and the ocular device 240.
[0055] The Fiber Optic Wand
[0056] The fiber optic wand or probe 300 provides a microscopic
view of a specific site on the tissue 99. The fiber optic wand 300
is a contacting optical probe that delivers a light beam 95 to the
tissue 99 via an array of multiple fiber optic excitation strands
or fibers 310 and collects the emanated light 96 from the tissue
with one or more fiber optic collection strands or fibers 312.
[0057] An oblique view of the optical probe 300 is shown in FIGS. 5
and 6. The probe has a shaft 370 with a transverse distal end 310
for placing on a tissue site 99 to be examined. The probe handle
380 is on an opposed proximal end of the probe 300. The embodiment
of the wand 300 shown in FIG. 5 has an on/off switch 360 mounted on
the handle 380 for selectably activating data acquisition by the
probe 300.
[0058] A continuous bi-directional fiber optic bundle 302 runs
through the handle 380 and the shaft 370 to the transverse distal
end 310 of the shaft 370. The fiber optic bundle 302 may be
constructed with any number of excitation 310 and collection fibers
312 in any configuration. A cross section of one embodiment of the
fiber optic bundle 302 is shown in FIG. 4. In this embodiment,
reflected or emitted light is received from the illuminated tissue
99 by a single centrally positioned reception strand (or collection
fiber 312) which is surrounded by coaxial multiple outer
illumination strands (or excitation fibers 310).
[0059] The distal tip 310 of the shaft 370 has a blunted surface or
a transverse surface to optimize contact with the tissue. The
optical probe 300 has an optional disposable sheath 350 for
isolating the shaft 370 from the tissue sample, when the wand 300
is to be used in the clinic. When the sheath is in use, the distal
tip 355 of the sheath 350 is blunted to provide good contact
between the distal tip 355 and the microscopic tissue area selected
for further spectral analysis. The sheath 350 and/or its distal tip
355 is constructed of a material that is non- or minimally light
scattering and transparent to the emitted wavelength band of light
used for the spectrographic investigation and any reflected or
fluorescent light passing back into the wand from the tissue 99. In
addition, the material should generate minimal autofluorescence. It
should be noted here that when the disposable sheath 350 is
positioned on the probe 300 that it is considered a part of the
probe and the distal end 355 of the sheath 350 becomes the distal
end of the probe 300.
[0060] The Detector Unit
[0061] The detector unit 400 is used to analyze the collected light
emanating from the tissue 99 that is transmitted through the
collection or reception strand(s) 312 through fiber optic cable 74.
Typically, the detector unit 400 obtains the spectra of the light
beam 96 received from the wand 300. The detector unit is primarily
a spectrometer 400, although it may include optical components for
conditioning and filtering the spectral data transmitted through
the collection fiber(s) 312. Such optical components may be a motor
actuated collection filter wheel 410 as shown in FIG. 2, or one or
more selected individual lens/filter(s) 405 as shown in FIG. 3.
[0062] The Processor Unit
[0063] The processing unit 500 includes a computer and/or one or
more controllers (hereinafter referred to as the
computer/controller 580). The processing unit 500 is programmed to
configure the operating mechanical and optical components of the
medical examination device that are not manually operated. In
addition, the computer/controller 580 processes measured and
derived data and is able to store and/or transfer such data.
[0064] Typically the medical examination device has a computer that
coordinates the overall operation of the device and saves patient
data, as well as several controllers for activating components such
as the solenoid 130 for moving the mirror 120 or activating the
motors for positioning the filter wheels to align the desired
filter/lens into a beam of light.
[0065] One embodiment of the computer/controller 580 and its
interaction with other components of the medical device system is
shown in FIG. 7. The embodiment shown in FIG. 7 is provided with
multiple bidirectional communication ports 10, 60, 61, and 62 to
which data lines 72, 71, 70, and 69 are respectively connected.
These communication ports may be used with a variety of optional
accessories such as shown in FIG. 8 where port 10 is connected to a
data storage device 91 through cable 88, port 61 is connected to an
external display 92 through cable 89, and port 62 is connected to
an external keyboard 93 through cable 90. An external computer is
optionally connected to the computer/controller 580 through one of
the ports such as port 60.
[0066] The bidirectional data line 73 from the computer/controller
580 to the user interface 550 permits the input of instructions to
the computer/controller 580 and the reporting of status to the user
through the user interface 550. Furthermore, a data line 68 from
the spectrometer 400 to the computer/controller 580 permits data
from the spectrometer 400 to be processed by the
computer/controller 580 and then stored.
[0067] The Power Supply
[0068] The power supply 600 for the medical examination device may
either be a rechargeable battery pack or supplied through an
electrical cord. FIG. 7 shows one embodiment of the power supply
600 and its interactions with other components of the medical
examination device.
[0069] FIG. 7 illustrates the power supply 600 in series with a
main power switch 610 for the device and an electric power cord
640. The power supply 600 regulates output voltages and currents
for the various electrical and electronic components of the overall
system of the medical examination device. Power from the power
supply 600 is fed to the visualization unit 200 via power cable
59a, to the processing unit 500 via power cable 59b, to the
detector 400 via the power cable 59c, to the illumination source
100 via the power cable 59d, and to the user interface 550 via the
power cable 59e.
[0070] The Medical Examination Device
[0071] Referring to FIGS. 9 and 10, a first embodiment 700 of the
medical examination device is seen in an oblique frontal view and
an oblique rear view. The first embodiment of the device 700
includes a viewer unit 701, a base unit 710, and a fiber optic wand
300 as interconnected subassemblies.
[0072] In FIG. 9, the medical examination device 700 is seen from
the front side, which is the side adjacent the patient and where
the light beam 97 is emitted from the visualization unit 200 and
the light beam 98 reflected or emitted as fluorescence from the
irradiated patient tissue is received. FIG. 10 shows the device 700
from the rear side which is accessed by the human operator when the
apparatus is in use.
[0073] The lamp 105 may be located in the base unit 710 or the
viewer unit 701, depending on the amount of heat generated by the
lamp and the heat's dissipation by fans, heat sinks, heat pipes,
and the like. Too much heat can adversely affect the life of the
lamp 105, as well as the electronics in the spectrometer 400 and in
the computer/controller 580.
[0074] The visualization unit 200, as see in the schematic
representation of FIG. 8, is positioned in the viewer unit 701 and
is connected to the power supply 600 located in the base unit 710
by the power cable 59a and fiber-optic cables 66 and 74.
[0075] In this first embodiment 700, the lamp 105 is positioned in
the visualization unit 200. Fiber optic cable 66 transmits light
from the lamp 105 through any selected lenses/filters and to the
light directing device. The beam of light is then directed either
in a first direction to the tissue 99 as beam 97, or the beam of
light is directed to the excitation fibers 310 of the wand fiber
optic cable 302 and transmitted to the tissue 99 as beam 95.
[0076] Reflectance or fluorescence light from the target specimen
99 in response to beam 97 is returned in a beam 98 to the viewer
unit 701, where it is filtered and visually displayed by binoculars
250 and photographed by an electronic camera 230. The camera data
is transferred to the computer/controller 580, located in the base
unit 710, by an instrument cable (not shown) and images of the
tissue 99 from the returning beam 98 may be seen on an external
display screen 92.
[0077] When the wand 300 of the device 700 is used, the light from
the fiber-optic cable 66 is filtered and then focused into the
bidirectional fiber optic cable 302. Excitation fibers 310 of the
fiber optic cable 302 transfers that light to the wand 300, where
it is emitted in a beam 95 upon the target tissue 99.
[0078] The light reflected back in a beam 96 from the tissue 99
typically has a different spectral content that the incident light,
depending on the character of the cells illuminated in the
specimen. This reflected light is transmitted back through the
collection fiber(s) 312 of the fiber optic cable 302 to the
spectrometer 400 in the base unit 710. The spectrometer 400 is in
communication with the computer/controller 580, which is typically
positioned in the base unit 710. The computer/controller 580 is
generally used to analyze the spectral data obtained from the
spectrometer 400 and stored in the data storage device 91.
[0079] The base unit 710 has a housing 79 which is mounted on a
three leg base 75. The base 75 has three approximately equispaced
horizontal arms, two of which have nonswiveling fixed casters 76,
while the third has a swiveling caster 17 which can be selectably
locked.
[0080] Extending vertically from the base 75 is a right circular
cylindrical tubular mast mount 77. At its upper end, the mast mount
77 is an aperture mounting a mast 78. At the upper end of the mast
mount 77 is located a mast height adjustment and lock 9. The mast
height adjustment and lock 9 consists of a radially inwardly
extending screw with an enlarged handle which is manually operated
to loosen or tighten the lock 9 against the mast 78.
[0081] The housing 79 mounted on the base unit 710 is typically a
blow-molded plastic box having a rectangular horizontal
cross-section and a horizontal flat bottom, along with rounded
corners. The long horizontal dimension of the housing 79 is
oriented with the radially extending horizontal leg of the
three-leg base 75 upon which it is mounted. The upper face of the
housing 79 slopes slightly downwardly in a radial direction.
[0082] On its vertical rear face adjacent the mast mount 77, the
housing 79 has an inwardly recessed mounting pocket in which are
positioned electrical/electronic connection sockets such as
communication ports 10, 60, 61, and 62. On its right side near the
bottom is another recessed pocket where the electrical power cord
640 enters the housing 79. A main power switch is also positioned
there. Various other penetrations for electrical and fiber-optical
cables are provided as needed in the housing 79.
[0083] An array of cooling vents 16 is positioned on the rear
vertical face of the housing 79 to assist in dissipating any
excessive heat buildup within the housing. If necessary, a fan (not
shown) can be provided inside the housing 79 to aid maintaining a
suitable operating temperature within the housing 79.
[0084] An indicator light 12 is shown in FIG. 10 mounted on the
upper surface of the housing 79. This indicator light 12 is the
startup fault indicator which is connected to the
computer/controller 580 and is illuminated when the automated
startup and checking routine programmed into the
computer/controller 580 experiences a problem.
[0085] Planar tray 13 is parallel to and attached to the upper face
of the housing 79 and provides additional working space for writing
and the like, while a through hole in the right side of the tray
provides a stowage position for the loose stabbing mounting of the
wand 300. Additionally, the user interface 550 is mounted either to
the upper side of housing 79 or to the upper side of tray 13.
[0086] The base unit 710 contains the electric power cord 640 in
series with the main power switch 610 and a power supply 600. Power
from the power supply 600 is fed to the user interface 550 via
power cable 59e, to the computer/controller 580 by cable 59b, to
the spectrometer 400 by cable 59c, to the xenon arc lamp 105 by
cable 59d, and to the viewer unit 701 by power cable 59a.
[0087] The computer/controller 580 is programmed to configure the
operating mechanical and optical components of the viewer unit 701
and the base unit 710 that are not manually operated. In addition,
the computer/controller 580 processes measured and derived spectral
data from the spectrometer 400 and then stores, calculates and/or
transfers such data.
[0088] The computer/controller 580 has communication ports 10, 60,
61, and 62 respectively connected to data lines 72, 71, 70, and 69.
A number of optional external electronic accessories are useable
with the examination device 700.
[0089] The wand 300 has an elongated central small diameter hollow
right circular cylindrical stainless steel shaft 370 which is
coaxial with the bidirectional fiber optic cable 302 and a coaxial
rectangular cross-section handle 380 located at the proximal end of
the wand 300. Handle 380 mounts a switch 360 on one side for
selectably activating data acquisition by the device.
[0090] The distal end of the shaft 370 is reduced in diameter. A
continuous bidirectional coaxial light path is provided by fiber
optic cable 302 through the handle 380 and the shaft 370 to the
transverse distal end 310 of the shaft 370. When in clinical use, a
close fitting tubular transparent disposable plastic sheath 350
having a thin transverse distal end 355 is typically interposed
over the shaft 370 for sanitary reasons.
[0091] The light used by the wand 300 is transmitted to and from
the device 700 over the bidirectional fiber optic cable 302.
Reflected or emitted light received from the illuminated target
tissue 99 is received by a single centrally positioned reception
fiber 312 and sent to the spectrometer 400. The coaxial emission
fibers 310 that surround the reception fiber 312 send light passed
from the viewer unit 701 to the wand 300.
[0092] The viewer unit 701 is mounted on top of the extendable mast
78. The viewer unit 701 in turn supports the wand 300. The viewer
unit 701 serves a light distribution and capture function for the
overall apparatus 700.
[0093] The viewer unit 701 has, from its lower end, a tilt and tilt
lock adjustment 7 attached to the top end of the extendable mast 78
of the base unit 710, a fine focus and focus lock adjustment 6, and
a housing 120 which supports and contains most of the subassemblies
and components of the viewer unit 701.
[0094] The housing 120 of the viewer unit 701 is hollow and made of
blow-molded plastic so that its corners are rounded. The lower
portion of housing 120 has a rectangular horizontal cross-section
which linearly tapers upwardly where it joins an enlarged upper
head portion. The upper head portion extends slightly forward and a
relatively larger distance rearward. The upper head is tapered so
that it widens and gets taller as it extends rearwardly from the
front vertical face. A vertically elongated window 5 is centrally
located on the forward vertical face of the upper head, while the
rearward vertical face has a central recess where the binocular 250
viewing unit and its rearwardly horizontally extending binocular
eyepieces are mounted. The housing 120 is pierced in its lower
section to admit the power cable 59a and one or more other
electrical data cables (not shown) into the interior of housing
120.
[0095] The user interface 550 is shown in FIGS. 14 and 15. The user
interface 550 is a relatively simple operator interface device with
multiple selector switches, status indicator lights, and a liquid
crystal display (LCD) for text or graphic signal messages. The user
interface can be either permanently mounted onto the upper surface
of the housing 79 of the base unit 710 or made separable so that it
is connected to the base unit 710 by an intermediate cable
containing data line 73 and power line 59e.
[0096] A second embodiment 800 of the medical examination device is
seen in use in an oblique side view in FIG. 11, a stowed position
side view in FIG. 12, and a stowed position frontal view in FIG.
13.
[0097] The second embodiment of the examination device 800 consists
of a viewer unit 803, a base unit 801, and a wand 300 as
interconnected primary subassemblies. The base unit 801 is
functionally similar to base unit 710 of the first embodiment 700,
although the base unit is repackaged in order to permit it to stow
more compactly and the casters are eliminated. The wand in the
device 800 is substantially similar to wand of the first device
embodiment 700, except that the wand extends from the base unit 801
rather than the viewer unit 803.
[0098] The light directing device illustrated in FIG. 2 is easily
configured to direct the light to the wand 300 from the base unit
801. The viewer unit 803 is also functionally similar to viewer
unit 701 of the first embodiment. One primary difference is that
the viewer unit 803 is mounted on an articulated arm 804 with
joints which are either frictionally restrained or restrained by a
selectably actuated locking mechanism so that the linkage will
remain rigidly in place until the operator elects to reposition
it.
[0099] Operation of the Medical Examination Device
[0100] The medical examination device is connected to a power
source. For example, the electrical power cord 640 is plugged into
the wall. The power to the medical examination device is turned on
at the main power switch 610.
[0101] FIGS. 14 and 15 illustrate one embodiment of the user
interface 550 that interacts with the medical examination device.
The user interface 550 is turned on using a power button 18 located
at the upper right side of the user interface device. The power
button 18 serves as an off/on switch for the user interface 550,
while the power indicator 19 is a status light for showing the
power off/on status of the user interface.
[0102] Once the power is turned on, the medical examination device
undergoes a test of its various components. The base unit
electronics are initially tested and if the system passes the base
unit test, then the lamp 105 is turned on and the visualization
unit is tested and the viewer and camera 230 are calibrated. Then
the wand 300 is turned on and calibrated. If all of the components
pass the tests and are properly calibrated, then the system either
goes into a standby mode, or an operational mode.
[0103] An indicator light 12 is shown in FIG. 10 mounted on the
upper surface of the housing 79. This indicator light 12 is the
startup fault indicator which is connected to the
computer/controller 580 and is illuminated when the automated
startup and checking routine programmed into the
computer/controller 580 experiences a problem. Just below the power
button 18 on the user interface 550 is an LCD user interface
display 20. If the automated startup and checking routine
programmed into the computer/controller 580 experiences a problem,
the specific problem will be identified on the user interface
display 20 as "Error X" where the X represents a numerical
designation of the specific instrument error encountered.
[0104] FIG. 14 shows a new patient button switch 21, a patient
completion button switch 22, and a save button switch 23, arranged
from left to right adjacent the bottom edge of the LCD user
interface display 20. Button switches 21, 22, and 23 provide
operator instructions to the computer/controller 580.
[0105] On the left side of the user interface 550 below the new
patient button switch 21, a view button switch 24, a display wand
button switch 25, and a display image button switch 26 are
sequentially downwardly positioned. These operator selectable
switches provide operator instructions to the computer/controller
580. On the right side of the user interface 550 below the patient
completion button switch 22, an up button switch 27, a
select/acquire button switch 28, and a down button switch 29 are
sequentially downwardly positioned.
[0106] To begin acquiring patient data, the new patient button
switch 21 is pushed to signal the computer/controller 580 to begin.
Typically the view mode, or colposcope mode, will be activated
first by pressing the view button switch 24. When the visualization
unit 200 is on and the display image button 26 is pressed, real
time images of a macroscopic region of the illuminated area of the
cervix are displayed through the ocular viewer 240, the camera 230,
and/or an external monitor display 92. Fluorescent and/or
reflectance spectra are typically used for the operator's initial
screen of the tissue. The operator of the medical examination
device can use these real time reflected images to select a desired
area of the tissue for further spectral analysis.
[0107] One or more excitation fluorescence bandwidths may be used,
such as 455-465 nm, 410-430 nm, 375-385 nm and/or 340-360 nm, to
excite the tissue. Similarly if reflectance is used to examine the
tissue, then white light (400-700 nm), or narrower bands such as
455-465 nm, 410-430 nm or 550-590 nm may be used to illuminate the
tissue. Parallel and/or cross-polarized light may also be used to
enhance different tissue structures.
[0108] Once the operator has selected a data acquisition area of
the tissue 99, the select/acquire button 28 is pressed to signal
the computer/controller 580 to begin acquiring an image set for the
selected area of illuminated tissue. An image set includes an image
captured and displayed on the external monitor for each of the
filters used to select particular excitation wavelengths of light,
as for example each of the filters in the excitation filter wheel
112. One embodiment of the medical examination device uses six
images in a set, three reflectance images (white, blue and violet)
and three fluorescent images (ultraviolet, violet and blue). As
shown in FIG. 16, each image of the set is associated with a
reference number and an abbreviated name for the type of excitation
beam used to illuminate the tissue.
[0109] Once the images of the tissue have been captured, the
display image button 26 is pressed to shut off the light and
display the images on the monitor 92. All six of the images may be
displayed on the monitor as illustrated in FIG. 17, or a single
image may be selected and shown on the monitor as shown in FIG. 18.
The up button switch 27, the select/acquire button switch 28, and
the down button switch 29 are used to cycle through the images and
select the particular image that the operator desires to
examine.
[0110] The LCD user interface display 20 has several different text
or symbolical status displays which are programmed to appear in
predetermined locations on the display. Examples of the symbols
displayed for the view mode are illustrated in FIG. 14. The upper
left corner of the LCD user interface display 20 holds the
instrument mode display 30, which in this case indicates the "View"
mode associated with use of the visualization unit 200, or the
colposcope mode. The lower left corner of the LCD user interface
display 20 holds the filter settings display 31, showing in this
case that the "Rf 1 White" filter (i.e., white light reflectance)
is in use. The upper right corner of the LCD user interface display
20 holds the illumination timer display 32, showing that the tissue
was illuminated ("1 minute and 16 seconds"). The lower right corner
holds a symbolic indicator 34 which indicates that the illumination
is on ("<") or off (">").
[0111] FIG. 18 illustrates an external monitor display of a
macroscopic view 41 of the illuminated cervix. An electronically
displayed set of pertinent sample data is displayed around the
periphery of the visual image of the tissue specimen 99 as seen
through the binocular 250, the camera 230, and/or on an optional
external monitor display 92.
[0112] Examples of text or symbolic status displays shown on the
monitor showing the real time view of the cervix are also shown in
FIG. 18. The top left corner gives the patient identifier 39
("20070825") and right below the patient identifier is the current
filter setting, in this case Filter 5 or a fluorescent violet light
beam for the excitation of the tissue. In the center at the top of
the monitor is the illumination timer display and at the top right
is a removable memory capacity indicator 42. At the bottom right
hand corner of the monitor is the firmware revision 44 being used
to interact with the computer/controller 580 and store the patient
images.
[0113] The operator may acquire a set of images for a number of
areas on the tissue. For example, one embodiment of the medical
examination device allows the operator to acquire and store four
sets of six images of the tissue for each patient. An experienced
operator can select tissue regions that appear abnormal or that are
suspect as cancerous or pre-cancerous for further analysis.
[0114] Once the operator has examined the cervical images and
selected one or more areas for further analysis, the operator may
press the view button 24 for a real time view of a cervical area
and place the tip 310 of the wand 300 or the distal tip 355 of the
disposable sheath 350 in contact with the selected area of the
tissue. Generally, the distal tip 310 of the wand and the distal
tip 355 of the disposable sheath 350 is blunted or flat to
facilitate good contact between the distal tip 310 or 355 with the
microscopic area of the tissue selected for spectral analysis. The
operator can contact the exact area of the tissue that is desired
with the wand 300, because the operator can watch a real-time view
of the wand 300 being placed in contact with the tissue while the
device is in the view mode.
[0115] Once the wand 300 is in place, the display wand button 25 is
pressed and the light directing device will direct the beam of
light to the optical probe or wand 300. The operator can see the
selected contact area on the monitor to further verify the proper
placement of the wand 300. The wand 300 is a microscopic probe used
to acquire a spectral analysis of one or a few cells of the cervix
versus the macroscopic view of the cervix seen by the colposcope
mode.
[0116] Once the positioning of the wand 300 is verified, the
operator can then press the on/off switch 360 mounted on the handle
380 of the wand to selectably activate data acquisition by the
probe or wand 300. The probe will deliver the light beam 95 to the
tissue 99 via an array of multiple fiber optic excitation fibers
310 and collect the emanated light 96 from the tissue via one or
more collection fibers 312.
[0117] One or more excitation bandwidths may be used and one or
more collection bandwidths may be used for spectral analysis of the
tissue. For example, white light (400-700 nm) may be delivered to
the tissue and the reflected light collected via the collection
fibers 312 and sent to the detector unit 400. Similarly,
fluorescent light of one or more wavelengths may be used to excite
the tissue and the spectra of the collected light obtained by the
detector unit 400 and sent to the computer/controller 580 for
spectral analysis.
[0118] For example, one embodiment of the wand 300 is programmed to
collect and process the four spectral images, one reflectance image
and three fluorescent images. The computer/controller 580 uses
programmed algorithms to analyze the spectral data collected to
assess the likelihood of disease at the site analyzed. The
likelihood of disease, pre-cancerous or cancerous tissue changes,
is reported as a composite of the four spectra as a probability
score between 0 and 100, referred to as the spectroscopic
evaluation result or the assessment index.
[0119] In FIG. 15, the LCD user interface display 20 shows a
typical display when the wand 300 and its associated spectroscopic
diagnostic procedures are in use. The instrument mode display 30
shows that the wand 300 has been enabled, while the illumination
timer 32 indicates the elapsed time during the wand operation
("07:32"). A wand measurement acquisition number display 54
("Result") is shown on the left bottom side of the LCD, while a
spectroscopic evaluation result 55 ("01:082") is shown as the
numerical scale assessment index at the right bottom side of the
LCD.
[0120] The operator can utilize the wand 300 to acquire a set of
spectral images and an assessment index for a number of sites on
the tissue. The results of a series of data acquisitions may be
shown on the external monitor as illustrated in FIG. 19 and any
specific result may be selected using the up button 27, the down
button 29 and the select/acquire button 28.
[0121] Once the data on a patient has been acquired (i.e., the
macroscopic sets of images and the assessment index for a number of
tissue sites), the save button is pushed and all of the data is
saved and stored under the corresponding patient number. The
operator then presses the patient complete button and can begin the
assessment of a new patient.
[0122] Currently, the likelihood of cervical disease is determined
by examining the cervix using a colposcope and performing a biopsy
on suspect areas of the cervix. The medical examination device of
the present invention provides for an on site evaluation of the
cervix for the likelihood of disease with the view mode providing a
macroscopic view of the cervix tissue illuminated with various
wavelengths of light and a microscopic spectral analysis of various
sites in the cervix suspected of disease. Such an on site
assessment of cervical tissue negates the need for a patient to
reschedule an appointment at a different location and the need to
wait for a biopsy report. Thus, the medical examination device
makes diagnosis and treatment more readily available and affordable
for women.
[0123] It should be appreciated by those skilled in the art that
the conception and the specific embodiment disclosed might be
readily utilized as a basis for modifying or redesigning the
medical examination device for carrying out the same purposes as
the invention. It should be realized by those skilled in the art
that such equivalent constructions do not depart from the spirit
and scope of the invention as set forth in the appended claims.
* * * * *