US20090062662A1 - Optical spectroscopic device for the identification of cervical cancer - Google Patents
Optical spectroscopic device for the identification of cervical cancer Download PDFInfo
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- US20090062662A1 US20090062662A1 US12/229,541 US22954108A US2009062662A1 US 20090062662 A1 US20090062662 A1 US 20090062662A1 US 22954108 A US22954108 A US 22954108A US 2009062662 A1 US2009062662 A1 US 2009062662A1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N21/6486—Measuring fluorescence of biological material, e.g. DNA, RNA, cells
-
- 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
- A61B1/00043—Operational features of endoscopes provided with output arrangements
- A61B1/00045—Display arrangement
- A61B1/00048—Constructional features of the display
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- A61B1/00163—Optical arrangements
- A61B1/00195—Optical arrangements with eyepieces
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61B1/045—Control thereof
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- A—HUMAN NECESSITIES
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- 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
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- 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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- 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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- 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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- A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
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- A61B1/00163—Optical arrangements
- A61B1/00193—Optical arrangements adapted for stereoscopic vision
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- 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
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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
- A61B1/06—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
- A61B1/07—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 using light-conductive means, e.g. optical fibres
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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
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2201/00—Features of devices classified in G01N21/00
- G01N2201/08—Optical fibres; light guides
- G01N2201/084—Fibres for remote transmission
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, pursuant to 35 U.S.C. 111(b), claims the benefit of the earlier filing date of provisional application Ser. No. 60/966,382 filed Aug. 27, 2007, and entitled “Medical Examination Device” and 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% 0f 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.
- A second embodiment of the invention is a medical examination device comprising: an illumination source, wherein the illumination source includes a lamp and a light directing device for selectably directing a beam of light from the lamp in a first direction or in a second direction; a visualization unit that receives the beam of light directed in the first direction from the illumination source and radiates a tissue with the received beam of light, the visualization unit visualizes a macroscopic view of the tissue from the light emanating from the tissue illuminated with the beam of light; a fiber optic probe including both an excitation fiber optic strand and a reception fiber optic strand, wherein the excitation fiber optic strand receives the beam of light directed in the second direction from the illumination source and transmits the received beam of light to radiate the tissue at a site of contact with a distal end of the probe, and wherein the collection fiber optic strand receives the light emanating from the tissue illuminated with the beam of light from the excitation fiber optic strand and transmits the light to a detector for spectral analysis.
- 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 engaged filters for preparing a beam of light with a selected wavelength; a light beam directing device for directing the beam of light into a first beam position or a second beam position; a visualization unit that receives the beam of light in the first beam position and radiates a tissue with the received beam of light, the visualization unit further comprising an ocular device that visualizes a macroscopic view of the tissue from the light emanating from the tissue illuminated with the 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 reception fiber optic strand, wherein the excitation fiber optic strands receive the beam of light in the second beam position and transmit the received beam of light to radiate the tissue at a site of contact with a distal end of the probe, and wherein the collection fiber optic strand receives the light emanating from the tissue illuminated with the second beam of light and transmits the light to a detector for spectral analysis.
- Yet another embodiment of the present invention is a method of screening for cervical cancer using spectral analysis comprising the steps of: illuminating a portion of a cervix with a first beam of light; visualizing a macroscopic view of the cervix from the light emanating from the tissue illuminated with the first beam of light; examining the macroscopic view of the cervix to select a tissue site for further investigation; placing a distal end of a fiber optic probe in contact with the selected tissue site while visualizing the macroscopic view of the cervix; transmitting a second beam of light though a fiber optic cable to illuminate the selected tissue site with the second beam of light to generate fluorescence or reflectance light at the selected tissue site; collecting the generated fluorescence or reflectance light; conducting a spectral analysis of the collected light using a spectrometer; and examining the spectral analysis to determine if 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 is a frontal view of the user interface of the device when the visualization unit has been selected for use. -
FIG. 12 is a frontal view of the user interface of the device when the optical probe has been selected for use. -
FIG. 13 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. 14 shows the external monitor display when the optical probe is in use and the “View Wand” mode has been selected. -
FIG. 15 shows an oblique view of a second embodiment of the medical examination device while in use. -
FIG. 16 is a side profile view of the device ofFIG. 15 in its stowed position. -
FIG. 17 is a rear view of the stowed device ofFIG. 15 . -
FIG. 18 is an oblique view of a third embodiment of the medical examination device using the optical probe for data acquisition on a patient. - 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. - 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 95 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
optical 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. Thedistal tip 355 of thesheath 350 is used to contact the tissue specimen of interest. 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. - 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 59 a 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 inFIG. 11 and 12 . 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. - Referring to
FIG. 11 , apower button 18 located at the upper right side of the panel of the device serves as an off/on switch for theuser interface 550, whilepower indicator 19 is a status light for showing the power off/on status of the user interface. Just below thepower button 18 is the LCD user interface display 20, with a newpatient button switch 21, a patientcompletion button switch 22, and asave button switch 23 arranged from left to right adjacent the bottom edge of the LCD display. 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, a view 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 patientcompletion button switch 22, an upbutton switch 27, a select/acquire button switch 28, and adown button switch 29 are sequentially downwardly positioned. - The LCD display has several different text or symbolical status displays which are programmed to appear in predetermined locations on the display. These symbols are illustrated in
FIGS. 11 and 12 . Referring toFIG. 11 , the upper left corner 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 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 holds theillumination timer display 32, showing 1 minute and 16 seconds. The lower right corner holds asymbolic indicator 34 which indicates that the illumination is on or off. - When the
visualization unit 200 is on and thedisplay image 26 is pressed, the macroscopic image of the illuminated area of the cervix is displayed through the ocular viewer, the camera, or an external monitor display.FIG. 13 illustrates an external monitor display having a live view 41 of the cervix from the camera. 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. The different text or symbolic status displays shown on the monitor are also shown inFIG. 13 . The top left corner gives thepatient 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 illumination. In the center at the top of the monitor is the illumination timer display and at the top right is the removablememory capacity indicator 42. At the bottom right hand corner of the monitor is thefirmware revision display 44. - In
FIG. 12 , the LCD of theuser interface 550 is showing 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. 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 a numerical scale assessment index at the right bottom side of the LCD. The complete results of a series of data acquisitions may also be shown as illustrated inFIG. 14 . - A
second embodiment 800 of the medical examination device is seen in use in an oblique side view inFIG. 15 , a stowed position side view inFIG. 16 , and a stowed position frontal view inFIG. 17 . - 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. - A third,
simplified embodiment 900 of the examination device is seen in use in an oblique side view inFIG. 18 . This embodiment is simplified to provide only awand 300 for making visual spectroscopic evaluations of selected tissue sites. Accordingly, the controls and support equipment are much simpler, permitting their inclusion within adesktop box 901. Thedesktop box 901 provides apower supply 600, alamp 105 with lenses/filters, some simplified controls, an electronicdigital camera 230, means for a liquid crystal display of the reflected light image of thetissue specimen 99, and aspectrometer 400 for numerically evaluating the results. The major difference in thethird embodiment 900 is that avisualization unit 200 is not provided. - 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.
Claims (32)
1. A medical examination device comprising:
an illumination source, wherein the illumination source includes a lamp and a light directing device for selectably directing a beam of light from the lamp in a first direction or in a second direction;
a visualization unit that receives the beam of light directed in the first direction from the illumination source and radiates a tissue with the received beam of light, the visualization unit visualizes a macroscopic view of the tissue from the light emanating from the tissue illuminated with the beam of light;
a fiber optic probe including both an excitation fiber optic strand and a reception fiber optic strand, wherein the excitation fiber optic strand receives the beam of light directed in the second direction from the illumination source and transmits the received beam of light to radiate the tissue at a site of contact with a distal end of the probe, and wherein the collection fiber optic strand receives the light emanating from the tissue illuminated with the beam of light from the excitation fiber optic strand and transmits the light to a detector for spectral analysis.
2. The medical examination device of claim 1 , further comprising a filter wheel between the lamp and the light directing device.
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 occular 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 recording the macroscopic view of the tissue.
8. The medical examination device of claim 1 , wherein the fiber optic probe has a transverse distal end for contacting the tissue.
9. The medical examination device of claim 1 , wherein the fiber optic probe includes a handle, a shaft, and a bi-directional fiber optic bundle with the reception fiber optic strand centrally positioned and surrounded by multiple coaxial excitation fiber optic strands.
10. The medical examination device of claim 9 , further comprising a disposable sheath for covering the shaft of the fiber optic probe.
11. The medical examination device of claim 1 , wherein the beam of light used to radiate the tissue for fluorescence excitation has a wavelength band of about 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
12. The medical examination device of claim 1 , wherein the beam of light used to radiate the tissue for reflectance visualization has a wavelength band of about 400-700 nm, 455-465 nm, or 410-430 nm.
13. The medical examination device of claim 12 , wherein the beam of light is polarized or unpolarized.
14. A medical examination device comprising:
an illumination source, wherein the illumination source includes a lamp and a plurality of selectably engaged filters for preparing a beam of light with a selected wavelength;
a light beam directing device for directing the beam of light into a first beam position or a second beam position;
a visualization unit that receives the beam of light in the first beam position and radiates a tissue with the received beam of light, the visualization unit further comprising an ocular device that visualizes a macroscopic view of the tissue from the light emanating from the tissue illuminated with the 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 reception fiber optic strand, wherein the excitation fiber optic strands receive the beam of light in the second beam position and transmit the received beam of light to radiate the tissue at a site of contact with a distal end of the probe, and wherein the collection fiber optic strand receives the light emanating from the tissue illuminated with the second beam of light and transmits the light to a detector for spectral analysis.
15. The medical examination device of claim 14 , wherein the plurality of filters are in a filter wheel.
16. The medical examination device of claim 14 , wherein the lamp is a plurality of selectable LEDs, a Xenon arc lamp, a Mercury arc lamp or a halogen lamp.
17. The medical examination device of claim 14 , wherein the light directing device includes a mirror that is reciprocable between a first mirror position and a second mirror position.
18. The medical examination device of claim 14 , wherein the light directing device includes a beam splitter.
19. The medical examination device of claim 14 , wherein the visualization unit includes a camera for recording the macroscopic view of the tissue.
20. The medical examination device of claim 14 , wherein the fiber optic probe has a transverse distal end for contacting the tissue.
21. The medical examination device of claim 14 , wherein the reception fiber optic strand is centrally positioned and surrounded by multiple coaxial excitation fiber optic strands.
22. The medical examination device of claim 14 , further comprising a disposable sheath for covering the shaft of the fiber optic probe.
23. The medical examination device of claim 14 , wherein the beam of light used to radiate the tissue for fluorescence excitation has a wavelength band of about 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
24. The medical examination device of claim 14 , wherein the beam of light used to radiate the tissue for reflectance visualization has a wavelength band of about 400-700 nm, 455-465 nm, or 410-430 nm.
25. The medical examination device of claim 24 , wherein the beam of light is polarized or unpolarized.
26. A method of screening for cervical cancer using spectral analysis comprising the steps of:
illuminating a portion of a cervix with a first beam of light;
visualizing a macroscopic view of the cervix from the light emanating from the tissue illuminated with the first beam of light;
examining the macroscopic view of the cervix to select a tissue site for further investigation;
placing a distal end of a fiber optic probe in contact with the selected tissue site while visualizing the macroscopic view of the cervix;
transmitting a second beam of light though a fiber optic cable to illuminate the selected tissue site with the second beam of light to generate fluorescence or reflectance light at the selected tissue site;
collecting the generated fluorescence or reflectance light;
conducting a spectral analysis of the collected light using a spectrometer; and
examining the spectral analysis to determine if the selected tissue site is cancerous.
27. The medical examination device of claim 26 , wherein the first beam of light used to radiate the tissue for fluorescence excitation has a wavelength band of about 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
28. The medical examination device of claim 26 , wherein the first beam of light used to radiate the tissue for reflectance visualization has a wavelength band of about 400-700 nm, 455-465 nm, or 410-430 nm.
29. The medical examination device of claim 28 , wherein the beam of light is polarized or unpolarized.
30. The medical examination device of claim 26 , wherein the beam of light used to radiate the tissue for fluorescence excitation has a wavelength band of about 455-465 nm, 410-430 nm, 375-385 nm, or 340-360 nm.
31. The medical examination device of claim 26 , wherein the beam of light used to radiate the tissue for reflectance visualization has a wavelength band of about 400-700 nm, 455-465 nm, or 410-430 nm.
32. The medical examination device of claim 31 , wherein the beam of light is polarized or unpolarized.
Priority Applications (10)
Application Number | Priority Date | Filing Date | Title |
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US12/229,541 US20090062662A1 (en) | 2007-08-27 | 2008-08-25 | Optical spectroscopic device for the identification of cervical cancer |
AU2008293972A AU2008293972B2 (en) | 2007-08-27 | 2008-08-26 | Optical spectroscopic device for the identification of cervical cancer |
CA2696340A CA2696340C (en) | 2007-08-27 | 2008-08-26 | Optical spectroscopic device for the identification of cervical cancer |
CN2008801026482A CN101828103B (en) | 2007-08-27 | 2008-08-26 | Optical spectroscopic device for the identification of cervical cancer |
PCT/US2008/010094 WO2009029254A1 (en) | 2007-08-27 | 2008-08-26 | Optical spectroscopic device for the identification of cervical cancer |
GB1004110A GB2465316B (en) | 2007-08-27 | 2008-08-26 | 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 |
PCT/US2008/011767 WO2009051728A1 (en) | 2007-10-16 | 2008-10-15 | Method and device for the optical spectroscopic identification of cervical cancer |
US13/467,866 US9157862B2 (en) | 2007-08-27 | 2012-05-09 | Optical spectroscopic device for the 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 |
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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 |
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US13/467,866 Continuation US9157862B2 (en) | 2007-08-27 | 2012-05-09 | Optical spectroscopic device for the identification of cervical cancer |
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US13/467,866 Expired - Fee Related US9157862B2 (en) | 2007-08-27 | 2012-05-09 | Optical spectroscopic device for the identification of cervical cancer |
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AU (1) | AU2008293972B2 (en) |
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GB2465316B (en) | 2011-11-02 |
GB2465316A (en) | 2010-05-19 |
US9157862B2 (en) | 2015-10-13 |
WO2009029254A1 (en) | 2009-03-05 |
US20120220880A1 (en) | 2012-08-30 |
AU2008293972B2 (en) | 2013-05-02 |
CA2696340C (en) | 2014-10-28 |
AU2008293972A1 (en) | 2009-03-05 |
GB201004110D0 (en) | 2010-04-28 |
CN101828103A (en) | 2010-09-08 |
CN101828103B (en) | 2012-11-07 |
CA2696340A1 (en) | 2009-03-05 |
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