US20090099460A1 - Method and device for the optical spectroscopic identification of cervical cancer - Google Patents
Method and device for the optical spectroscopic identification of cervical cancer Download PDFInfo
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- US20090099460A1 US20090099460A1 US12/287,801 US28780108A US2009099460A1 US 20090099460 A1 US20090099460 A1 US 20090099460A1 US 28780108 A US28780108 A US 28780108A US 2009099460 A1 US2009099460 A1 US 2009099460A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0071—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00002—Operational features of endoscopes
- A61B1/00039—Operational features of endoscopes provided with input arrangements for the user
- A61B1/00042—Operational features of endoscopes provided with input arrangements for the user for mechanical operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00163—Optical arrangements
- A61B1/00186—Optical arrangements with imaging filters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
- A61B1/042—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by a proximal camera, e.g. a CCD camera
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
- A61B1/043—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for fluorescence imaging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
- A61B1/0646—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements with illumination filters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/303—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the vagina, i.e. vaginoscopes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0075—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0437—Trolley or cart-type apparatus
Definitions
- 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.
- 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
- FIG. 3 is a schematic view showing the interrelationship of the components of one embodiment of the visualization unit.
- FIG. 6 is a view corresponding to FIG. 6 , but with the disposable sheath in position for contact with a patient.
- FIG. 9 is an oblique frontal view of the first embodiment of the device.
- FIG. 11 shows an oblique view of a second embodiment of the medical examination device while in use.
- FIG. 16 is a list of names given one example of a set of six different wavelengths of light used to illuminate the cervix.
- 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.
- 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.
- FIG. 19 shows the external monitor display of Wand Results for a set of tissue sites spectrally analyzed using the wand.
- 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.
- 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.
- 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).
- 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.
- the illumination source 100 includes a lamp 105 , an emergency shutter 102 , optional filters and a light directing device.
- 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 .
- This light directing device includes a mirror 120 that is rotatable between a 1 st mirror position 122 and a 2 nd mirror position 124 .
- the Visualization Unit The Visualization Unit
- 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.
- 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 .
- 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 .
- 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 .
- 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.
- 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 .
- 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.
- the new patient button switch 21 is pushed to signal the computer/controller 580 to begin.
- the view mode or colposcope mode, will be activated first by pressing the view button switch 24 .
- 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.
- 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.
- white light 400-700 nm
- 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.
- 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.
- 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.
- 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.
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.
Description
- 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.”
- 1. Field of the Invention
- 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.
- 2. Description of the Related Art
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
-
FIG. 1 is a schematic view illustrating the basic components of the medical examination device and their interrelationship. -
FIG. 2 is a schematic view showing the interrelationship of the components in one embodiment of the device. -
FIG. 3 is a schematic view showing the interrelationship of the components of one embodiment of the visualization unit. -
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. -
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. -
FIG. 6 is a view corresponding toFIG. 6 , but with the disposable sheath in position for contact with a patient. -
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. -
FIG. 8 is a schematic view illustrating the interaction of general components of the device and several optional accessories. -
FIG. 9 is an oblique frontal view of the first embodiment of the device. -
FIG. 10 is an oblique rear view of the device ofFIG. 1 . -
FIG. 11 shows an oblique view of a second embodiment of the medical examination device while in use. -
FIG. 12 is a side profile view of the device ofFIG. 11 in its stowed position. -
FIG. 13 is a rear view of the stowed device ofFIG. 11 . -
FIG. 14 is a frontal view of the user interface of the device when the visualization unit has been selected for use. -
FIG. 15 is a frontal view of the user interface of the device when the optical probe has been selected for use. -
FIG. 16 is a list of names given one example of a set of six different wavelengths of light used to illuminate the cervix. -
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. -
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. -
FIG. 19 shows the external monitor display of Wand Results for a set of tissue sites spectrally analyzed using the wand. - 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).
- 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.
- As illustrated in
FIG. 1 , the medical examination device has anillumination source 100, avisualization unit 200, an optical probe or fiberoptic wand 300, adetector 400, aprocessing unit 500, and apower 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. - I. Basic Components of the Medical Examination Device
- The Illumination Source
- One of the basic components of the medical examination device is the
illumination source 100. The illumination source includes alamp 105, anemergency shutter 102, optional filters and a light directing device. - 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. - 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 fromlamp 105 transmitted via a liquidlight guide 104 through anemergency shutter 102 that can be used to shut off all of the light being transmitted to the tissue in case of an emergency. - The illumination source also includes a light directing device that directs the light to either the
visualization unit 200 or theoptical probe 300. The medical examination device uses the same illumination source to provide the light beam for thevisualization unit 200 or theoptical probe 300. The light directing device selectably uses the illumination source for either thevisualization unit 200 or theoptical probe 300. An advantage of using a single illumination source for both thevisualization unit 200 and theoptical 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 thevisualization unit 200 or theoptical probe 300. - 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 theoptical probe 300. For example, one such embodiment of the light directing device is illustrated inFIG. 2 . This light directing device includes amirror 120 that is rotatable between a 1stmirror position 122 and a 2ndmirror position 124. - The
mirror 120 is biased into the 1stmirror position 122. The 1stmirror position 122 is up and allows the light beam to continue in a forward horizontal direction to enter theexcitation fibers 310 of thewand fiber bundle 302. Themirror 120 is moved into the 2ndmirror position 124 whenever thesolenoid 130 is selectably actuated. The 2ndmirror position 124 reflects the light upward to themirror 210 in thevisualization unit 200 which then reflects thelight beam 97 to thetissue 99 for assessment by thevisualization 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. - An alternative embodiment of the light directing device is shown in
FIG. 3 . Light from thelamp 105 is transmitted through afiber optic cable 66 through alens 64 and/or anexcitation filter 65 and into a beam splitter and/ordichroic mirror 122. The beam splitter and/or adichroic mirror 122 selectably diverts the light into a first forwardly extendinghorizontal path 97 to thetissue 99 for use in themacroscopic visualization unit 200 or into a second forwardly extendinghorizontal path 95 for use by thefiber optic wand 300. - 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. - The embodiment illustrated in
FIG. 2 uses both a motor actuatedconditioning filter wheel 110 and a motor actuatedexcitation filter wheel 112 to prepare the light used to illuminate thetissue 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 aslens 64 andfilter 65 illustrated inFIG. 3 . - 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.
- The Visualization Unit
- The
visualization unit 200 provides a wide field macroscopic view of thetissue 99. Thevisualization unit 200 is a non-contacting viewer of thetissue 99 and includes an ocular viewer, like a colposcope, and is referred to herein as the colposcope mode. Thevisualization unit 200 may optionally include acamera 230. Preferred embodiments will typically include abinocular viewer 250 and an electronicdigital camera 230 for displaying, capturing and storing reflectance and fluorescence images of theilluminated tissue 99. - One embodiment of the
visualization unit 200 shown inFIG. 2 directs alight beam 97 to thetissue sample 99. The beam oflight 98 resulting from thelight beam 97 impinging on thetissue sample 99 is optionally filtered or conditioned before being directed to abinocular viewer 250 or to acamera 230 for recording. The embodiment illustrated inFIG. 2 uses a motor actuatedfilter wheel 220 to filter or condition the beam oflight 98 before sending it through abeam splitter 128 that splits thelight beam 98 so that the image of the tissue can be seen through both thebinocular viewer 250 and thecamera 230. Alternatively, a light directing device that directs thelight beam 98 to either thebinocular viewer 98 or thecamera 230 may also be used. - The nature of the
light beam 98 will depend on the nature of the impinginglight beam 97. For example, if thelight beam 97 is white light, then the returninglight beam 98 is reflected light. Alternatively, if thelight beam 97 is fluorescent light that impinges on the surface of thetissue 99 causing it to fluoresce, then thelight beam 98 will be the resultant fluorescence from thetissue 99. - A second embodiment of the
visualization unit 200 is illustrated inFIG. 3 . The fluorescence or reflected light from thetissue 99 is returned in abeam 98 to thevisualization unit 200. This embodiment of thevisualization unit 200 passes thelight beam 98 through abeam splitter 128, and then optionally conditions or filters thebeam 98 using one or more preselected lenses or filters. For example, thebeam splitter 128 is shown splitting thelight beam 98 through a lens/filter 127 to be visually displayed to amonocular device 240 and through a lens/filter 123 to be photographed by acamera 230. - Alternatively, the same location on the sample may be viewed simultaneously through the
ocular viewer 240 and thecamera 230 by removing thebeam splitter 128 and independently adjusting the optics of thecamera 230 and theocular device 240. - The Fiber Optic Wand
- The fiber optic wand or probe 300 provides a microscopic view of a specific site on the
tissue 99. Thefiber optic wand 300 is a contacting optical probe that delivers alight beam 95 to thetissue 99 via an array of multiple fiber optic excitation strands orfibers 310 and collects the emanated light 96 from the tissue with one or more fiber optic collection strands orfibers 312. - An oblique view of the
optical probe 300 is shown inFIGS. 5 and 6 . The probe has ashaft 370 with a transversedistal end 310 for placing on atissue site 99 to be examined. The probe handle 380 is on an opposed proximal end of theprobe 300. The embodiment of thewand 300 shown inFIG. 5 has an on/offswitch 360 mounted on thehandle 380 for selectably activating data acquisition by theprobe 300. - A continuous bi-directional
fiber optic bundle 302 runs through thehandle 380 and theshaft 370 to the transversedistal end 310 of theshaft 370. Thefiber optic bundle 302 may be constructed with any number ofexcitation 310 andcollection fibers 312 in any configuration. A cross section of one embodiment of thefiber optic bundle 302 is shown inFIG. 4 . In this embodiment, reflected or emitted light is received from the illuminatedtissue 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). - The
distal tip 310 of theshaft 370 has a blunted surface or a transverse surface to optimize contact with the tissue. Theoptical probe 300 has an optionaldisposable sheath 350 for isolating theshaft 370 from the tissue sample, when thewand 300 is to be used in the clinic. When the sheath is in use, thedistal tip 355 of thesheath 350 is blunted to provide good contact between thedistal tip 355 and the microscopic tissue area selected for further spectral analysis. Thesheath 350 and/or itsdistal 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 thetissue 99. In addition, the material should generate minimal autofluorescence. It should be noted here that when thedisposable sheath 350 is positioned on theprobe 300 that it is considered a part of the probe and thedistal end 355 of thesheath 350 becomes the distal end of theprobe 300. - The Detector Unit
- The
detector unit 400 is used to analyze the collected light emanating from thetissue 99 that is transmitted through the collection or reception strand(s) 312 throughfiber optic cable 74. Typically, thedetector unit 400 obtains the spectra of thelight beam 96 received from thewand 300. The detector unit is primarily aspectrometer 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 actuatedcollection filter wheel 410 as shown inFIG. 2 , or one or more selected individual lens/filter(s) 405 as shown inFIG. 3 . - The Processor Unit
- The
processing unit 500 includes a computer and/or one or more controllers (hereinafter referred to as the computer/controller 580). Theprocessing 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. - 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 themirror 120 or activating the motors for positioning the filter wheels to align the desired filter/lens into a beam of light. - One embodiment of the computer/
controller 580 and its interaction with other components of the medical device system is shown inFIG. 7 . The embodiment shown inFIG. 7 is provided with multiplebidirectional communication ports FIG. 8 whereport 10 is connected to adata storage device 91 throughcable 88,port 61 is connected to anexternal display 92 throughcable 89, andport 62 is connected to anexternal keyboard 93 throughcable 90. An external computer is optionally connected to the computer/controller 580 through one of the ports such asport 60. - The
bidirectional data line 73 from the computer/controller 580 to theuser interface 550 permits the input of instructions to the computer/controller 580 and the reporting of status to the user through theuser interface 550. Furthermore, adata line 68 from thespectrometer 400 to the computer/controller 580 permits data from thespectrometer 400 to be processed by the computer/controller 580 and then stored. - The Power Supply
- 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 thepower supply 600 and its interactions with other components of the medical examination device. -
FIG. 7 illustrates thepower supply 600 in series with amain power switch 610 for the device and anelectric power cord 640. Thepower 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 thepower supply 600 is fed to thevisualization unit 200 viapower cable 59 a, to theprocessing unit 500 viapower cable 59 b, to thedetector 400 via thepower cable 59 c, to theillumination source 100 via thepower cable 59 d, and to theuser interface 550 via thepower cable 59 e. - The Medical Examination Device
- Referring to
FIGS. 9 and 10 , afirst embodiment 700 of the medical examination device is seen in an oblique frontal view and an oblique rear view. The first embodiment of thedevice 700 includes aviewer unit 701, abase unit 710, and afiber optic wand 300 as interconnected subassemblies. - In
FIG. 9 , themedical examination device 700 is seen from the front side, which is the side adjacent the patient and where thelight beam 97 is emitted from thevisualization unit 200 and thelight beam 98 reflected or emitted as fluorescence from the irradiated patient tissue is received.FIG. 10 shows thedevice 700 from the rear side which is accessed by the human operator when the apparatus is in use. - The
lamp 105 may be located in thebase unit 710 or theviewer 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 thelamp 105, as well as the electronics in thespectrometer 400 and in the computer/controller 580. - The
visualization unit 200, as see in the schematic representation ofFIG. 8 , is positioned in theviewer unit 701 and is connected to thepower supply 600 located in thebase unit 710 by thepower cable 59a and fiber-optic cables - In this
first embodiment 700, thelamp 105 is positioned in thevisualization unit 200.Fiber optic cable 66 transmits light from thelamp 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 thetissue 99 asbeam 97, or the beam of light is directed to theexcitation fibers 310 of the wandfiber optic cable 302 and transmitted to thetissue 99 asbeam 95. - Reflectance or fluorescence light from the
target specimen 99 in response tobeam 97 is returned in abeam 98 to theviewer unit 701, where it is filtered and visually displayed bybinoculars 250 and photographed by anelectronic camera 230. The camera data is transferred to the computer/controller 580, located in thebase unit 710, by an instrument cable (not shown) and images of thetissue 99 from the returningbeam 98 may be seen on anexternal display screen 92. - When the
wand 300 of thedevice 700 is used, the light from the fiber-optic cable 66 is filtered and then focused into the bidirectionalfiber optic cable 302.Excitation fibers 310 of thefiber optic cable 302 transfers that light to thewand 300, where it is emitted in abeam 95 upon thetarget tissue 99. - The light reflected back in a
beam 96 from thetissue 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 thefiber optic cable 302 to thespectrometer 400 in thebase unit 710. Thespectrometer 400 is in communication with the computer/controller 580, which is typically positioned in thebase unit 710. The computer/controller 580 is generally used to analyze the spectral data obtained from thespectrometer 400 and stored in thedata storage device 91. - The
base unit 710 has ahousing 79 which is mounted on a threeleg base 75. Thebase 75 has three approximately equispaced horizontal arms, two of which have nonswiveling fixedcasters 76, while the third has a swivelingcaster 17 which can be selectably locked. - Extending vertically from the
base 75 is a right circular cylindricaltubular mast mount 77. At its upper end, themast mount 77 is an aperture mounting amast 78. At the upper end of themast mount 77 is located a mast height adjustment andlock 9. The mast height adjustment andlock 9 consists of a radially inwardly extending screw with an enlarged handle which is manually operated to loosen or tighten thelock 9 against themast 78. - The
housing 79 mounted on thebase 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 thehousing 79 is oriented with the radially extending horizontal leg of the three-leg base 75 upon which it is mounted. The upper face of thehousing 79 slopes slightly downwardly in a radial direction. - On its vertical rear face adjacent the
mast mount 77, thehousing 79 has an inwardly recessed mounting pocket in which are positioned electrical/electronic connection sockets such ascommunication ports electrical power cord 640 enters thehousing 79. A main power switch is also positioned there. Various other penetrations for electrical and fiber-optical cables are provided as needed in thehousing 79. - An array of cooling
vents 16 is positioned on the rear vertical face of thehousing 79 to assist in dissipating any excessive heat buildup within the housing. If necessary, a fan (not shown) can be provided inside thehousing 79 to aid maintaining a suitable operating temperature within thehousing 79. - An
indicator light 12 is shown inFIG. 10 mounted on the upper surface of thehousing 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. -
Planar tray 13 is parallel to and attached to the upper face of thehousing 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 thewand 300. Additionally, theuser interface 550 is mounted either to the upper side ofhousing 79 or to the upper side oftray 13. - The
base unit 710 contains theelectric power cord 640 in series with themain power switch 610 and apower supply 600. Power from thepower supply 600 is fed to theuser interface 550 viapower cable 59 e, to the computer/controller 580 bycable 59 b, to thespectrometer 400 bycable 59 c, to thexenon arc lamp 105 bycable 59 d, and to theviewer unit 701 bypower cable 59 a. - The computer/
controller 580 is programmed to configure the operating mechanical and optical components of theviewer unit 701 and thebase unit 710 that are not manually operated. In addition, the computer/controller 580 processes measured and derived spectral data from thespectrometer 400 and then stores, calculates and/or transfers such data. - The computer/
controller 580 hascommunication ports data lines examination device 700. - The
wand 300 has an elongated central small diameter hollow right circular cylindricalstainless steel shaft 370 which is coaxial with the bidirectionalfiber optic cable 302 and a coaxial rectangular cross-section handle 380 located at the proximal end of thewand 300. Handle 380 mounts aswitch 360 on one side for selectably activating data acquisition by the device. - The distal end of the
shaft 370 is reduced in diameter. A continuous bidirectional coaxial light path is provided byfiber optic cable 302 through thehandle 380 and theshaft 370 to the transversedistal end 310 of theshaft 370. When in clinical use, a close fitting tubular transparent disposableplastic sheath 350 having a thin transversedistal end 355 is typically interposed over theshaft 370 for sanitary reasons. - The light used by the
wand 300 is transmitted to and from thedevice 700 over the bidirectionalfiber optic cable 302. Reflected or emitted light received from the illuminatedtarget tissue 99 is received by a single centrally positionedreception fiber 312 and sent to thespectrometer 400. Thecoaxial emission fibers 310 that surround thereception fiber 312 send light passed from theviewer unit 701 to thewand 300. - The
viewer unit 701 is mounted on top of theextendable mast 78. Theviewer unit 701 in turn supports thewand 300. Theviewer unit 701 serves a light distribution and capture function for theoverall apparatus 700. - The
viewer unit 701 has, from its lower end, a tilt and tiltlock adjustment 7 attached to the top end of theextendable mast 78 of thebase unit 710, a fine focus and focuslock adjustment 6, and ahousing 120 which supports and contains most of the subassemblies and components of theviewer unit 701. - The
housing 120 of theviewer unit 701 is hollow and made of blow-molded plastic so that its corners are rounded. The lower portion ofhousing 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 elongatedwindow 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. Thehousing 120 is pierced in its lower section to admit thepower cable 59 a and one or more other electrical data cables (not shown) into the interior ofhousing 120. - The
user interface 550 is shown inFIGS. 14 and 15 . Theuser 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 thehousing 79 of thebase unit 710 or made separable so that it is connected to thebase unit 710 by an intermediate cable containingdata line 73 andpower line 59 e. - A
second embodiment 800 of the medical examination device is seen in use in an oblique side view inFIG. 11 , a stowed position side view inFIG. 12 , and a stowed position frontal view inFIG. 13 . - The second embodiment of the
examination device 800 consists of aviewer unit 803, abase unit 801, and awand 300 as interconnected primary subassemblies. Thebase unit 801 is functionally similar tobase unit 710 of thefirst 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 thedevice 800 is substantially similar to wand of thefirst device embodiment 700, except that the wand extends from thebase unit 801 rather than theviewer unit 803. - The light directing device illustrated in
FIG. 2 is easily configured to direct the light to thewand 300 from thebase unit 801. Theviewer unit 803 is also functionally similar toviewer unit 701 of the first embodiment. One primary difference is that theviewer unit 803 is mounted on an articulatedarm 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. - Operation of the Medical Examination Device
- 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 themain power switch 610. -
FIGS. 14 and 15 illustrate one embodiment of theuser interface 550 that interacts with the medical examination device. Theuser interface 550 is turned on using apower button 18 located at the upper right side of the user interface device. Thepower button 18 serves as an off/on switch for theuser interface 550, while thepower indicator 19 is a status light for showing the power off/on status of the user interface. - 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 andcamera 230 are calibrated. Then thewand 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. - An
indicator light 12 is shown inFIG. 10 mounted on the upper surface of thehousing 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 thepower button 18 on theuser interface 550 is an LCDuser 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 theuser interface display 20 as “Error X” where the X represents a numerical designation of the specific instrument error encountered. -
FIG. 14 shows a newpatient button switch 21, a patient completion button switch 22, and asave button switch 23, arranged from left to right adjacent the bottom edge of the LCDuser interface display 20. Button switches 21, 22, and 23 provide operator instructions to the computer/controller 580. - On the left side of the
user interface 550 below the newpatient button switch 21, aview button switch 24, a displaywand button switch 25, and a displayimage button switch 26 are sequentially downwardly positioned. These operator selectable switches provide operator instructions to the computer/controller 580. On the right side of theuser interface 550 below the patient completion button switch 22, an upbutton switch 27, a select/acquire button switch 28, and adown button switch 29 are sequentially downwardly positioned. - 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 theview button switch 24. When thevisualization unit 200 is on and thedisplay image button 26 is pressed, real time images of a macroscopic region of the illuminated area of the cervix are displayed through theocular viewer 240, thecamera 230, and/or anexternal 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. - 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.
- 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 theexcitation 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 inFIG. 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. - 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 themonitor 92. All six of the images may be displayed on the monitor as illustrated inFIG. 17 , or a single image may be selected and shown on the monitor as shown inFIG. 18 . The upbutton switch 27, the select/acquire button switch 28, and thedown button switch 29 are used to cycle through the images and select the particular image that the operator desires to examine. - 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 inFIG. 14 . The upper left corner of the LCDuser interface display 20 holds theinstrument mode display 30, which in this case indicates the “View” mode associated with use of thevisualization unit 200, or the colposcope mode. The lower left corner of the LCDuser 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 LCDuser interface display 20 holds theillumination timer display 32, showing that the tissue was illuminated (“1 minute and 16 seconds”). The lower right corner holds asymbolic indicator 34 which indicates that the illumination is on (“<”) or off (“>”). -
FIG. 18 illustrates an external monitor display of amacroscopic view 41 of the illuminated cervix. An electronically displayed set of pertinent sample data is displayed around the periphery of the visual image of thetissue specimen 99 as seen through the binocular 250, thecamera 230, and/or on an optionalexternal monitor display 92. - 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 thiscase 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 removablememory capacity indicator 42. At the bottom right hand corner of the monitor is thefirmware revision 44 being used to interact with the computer/controller 580 and store the patient images. - 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.
- 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 thetip 310 of thewand 300 or thedistal tip 355 of thedisposable sheath 350 in contact with the selected area of the tissue. Generally, thedistal tip 310 of the wand and thedistal tip 355 of thedisposable sheath 350 is blunted or flat to facilitate good contact between thedistal tip wand 300, because the operator can watch a real-time view of thewand 300 being placed in contact with the tissue while the device is in the view mode. - Once the
wand 300 is in place, thedisplay wand button 25 is pressed and the light directing device will direct the beam of light to the optical probe orwand 300. The operator can see the selected contact area on the monitor to further verify the proper placement of thewand 300. Thewand 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. - Once the positioning of the
wand 300 is verified, the operator can then press the on/offswitch 360 mounted on thehandle 380 of the wand to selectably activate data acquisition by the probe orwand 300. The probe will deliver thelight beam 95 to thetissue 99 via an array of multiple fiberoptic excitation fibers 310 and collect the emanated light 96 from the tissue via one ormore collection fibers 312. - 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 thedetector 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 thedetector unit 400 and sent to the computer/controller 580 for spectral analysis. - 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. - In
FIG. 15 , the LCDuser interface display 20 shows a typical display when thewand 300 and its associated spectroscopic diagnostic procedures are in use. Theinstrument mode display 30 shows that thewand 300 has been enabled, while theillumination 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. - 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 inFIG. 19 and any specific result may be selected using the upbutton 27, thedown button 29 and the select/acquire button 28. - 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.
- 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.
- 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.
Claims (29)
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.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/287,801 US20090099460A1 (en) | 2007-10-16 | 2008-10-14 | Method and device for the optical spectroscopic identification of cervical cancer |
PCT/US2008/011767 WO2009051728A1 (en) | 2007-10-16 | 2008-10-15 | Method and device for the optical spectroscopic identification of cervical cancer |
US13/469,269 US9198579B2 (en) | 2007-10-16 | 2012-05-11 | Method and device for the optical spectroscopic identification of cervical cancer |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US99909507P | 2007-10-16 | 2007-10-16 | |
US12/229,541 US20090062662A1 (en) | 2007-08-27 | 2008-08-25 | Optical spectroscopic device for the identification of cervical cancer |
US12/287,801 US20090099460A1 (en) | 2007-10-16 | 2008-10-14 | Method and device for the optical spectroscopic identification of cervical cancer |
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US12/229,541 Continuation-In-Part US20090062662A1 (en) | 2007-08-27 | 2008-08-25 | Optical spectroscopic device for the identification of cervical cancer |
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Also Published As
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WO2009051728A1 (en) | 2009-04-23 |
US9198579B2 (en) | 2015-12-01 |
US20120226167A1 (en) | 2012-09-06 |
WO2009051728A8 (en) | 2009-09-03 |
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