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WO2008153569A1 - Système optique d'imagerie de lésions tissulaires - Google Patents

Système optique d'imagerie de lésions tissulaires Download PDF

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Publication number
WO2008153569A1
WO2008153569A1 PCT/US2007/071296 US2007071296W WO2008153569A1 WO 2008153569 A1 WO2008153569 A1 WO 2008153569A1 US 2007071296 W US2007071296 W US 2007071296W WO 2008153569 A1 WO2008153569 A1 WO 2008153569A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
light source
light
frame
camera
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2007/071296
Other languages
English (en)
Inventor
Mohammed Saidur Rahman
Rebecca Rae Richards-Kortum
Ann M. Gillenwater
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
William Marsh Rice University
Original Assignee
William Marsh Rice University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by William Marsh Rice University filed Critical William Marsh Rice University
Priority to PCT/US2007/071296 priority Critical patent/WO2008153569A1/fr
Publication of WO2008153569A1 publication Critical patent/WO2008153569A1/fr
Priority to US12/638,459 priority patent/US20100210951A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/04Instruments 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
    • A61B1/043Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/06Instruments 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
    • A61B1/0646Instruments 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/06Instruments 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
    • A61B1/0661Endoscope light sources
    • A61B1/0684Endoscope light sources using light emitting diodes [LED]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/06Instruments 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
    • A61B1/0661Endoscope light sources
    • A61B1/0692Endoscope light sources head mounted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/24Instruments 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 mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0071Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0075Measuring 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084Measuring 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
    • A61B5/0086Measuring 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 using infrared radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0088Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for oral or dental tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00163Optical arrangements
    • A61B1/00186Optical arrangements with imaging filters

Definitions

  • the 5-year survival rate for oral cancer is one of the lowest of all major cancers. In the U.S., only 54% of all patients with oral cancer live for five years or more after the initial diagnosis [2]. The survival rate drops below 30% for developing countries mainly due to the lack of awareness, inadequate screening programs, and inability to detect disease in early stages [3]. Although it has been shown that early detection can improve the 5-year survival rate to 80%, there has been very little improvement over the last three decades on the survival outcome of oral cancer. For the vast majority of cases, the disease is diagnosed late at an advanced stage, requiring more aggressive treatment and still resulting in poor survival and increased morbidity. Thus, detecting oral cancer at an early stage remains key to improving survival outcome of the disease and quality of life for patients.
  • the standard method for screening and detection of oral neoplasia is visual inspection of oral cavity under white light. Once identified, suspicious lesions must be biopsied and undergo histological evaluation to determine the presence and extent of the disease. Clinical manifestations such as white patches (leukoplakia) and red patches (erythroplakia), are assessed during the visual examination to mark suspected lesions [4]. Unfortunately, even for experienced physicians these clinical signatures are difficult to differentiate from nonspecific inflammation and irritation which also appears as white or red patches. Furthermore, many lesions appear clinically occult, which can also result in a failure to biopsy. Although biopsy can be used as an alternative screening method, it is not a practical solution as it can both result in patient discomfort and accrue the cost especially when screening large populations in developing countries. Altogether, a non-invasive low-cost screening tool is needed that is both sensitive and specific and can be easily translated to the poor resource settings in developing countries.
  • Fluorescence imaging has been shown to be an effective alternative method for screening and diagnosis of pre-cancers in several organ sites including oral cavity, cervix, lung and skin [5-10].
  • Several groups including Betz et al, Onizawa et al, Paczona et al and Sivstun et al have shown that examining the oral cavity under a fluorescence excitation light source can overcome some of the detection limitations associated with standard white light examination.
  • Betz et al and Paczona et al used a xenon arc lamp as a light source to excite tissue at wavelengths between 375-440nm and detect the autofluorescence signals above 515nm using a color CCD [7, 8].
  • Onizawa et al used an UV flash lamp with an illumination peak at 360nm to induce porphyrin-like fluorescence at 630nm and recorded signals on photographic film [9]. Later, Sivstun et al conducted a study to find the optimal excitation and emission wavelengths for direct visualization of oral cavity for differentiating normal tissue from neoplasia [10]. Lane et al recently proposed a simple hand-held device for direct visualization of tissue autofluorescence above 480nm using a metal halide mercury lamp with excitation wavelengths between 360-460nm [H]. The device is currently approved for medical use by the Food and Drug Administration (FDA) in the U.S. All of these studies highlight the fact that examining the autofluorescence signal of the oral cavity under fluorescence excitation wavelengths between 360-460nm can be a powerful tool for screening oral cancer.
  • FDA Food and Drug Administration
  • an a device for examining tissue comprising: a frame, at least one light-emitting diode light source mounted on the frame for illuminating a tissue, wherein the at least one light-emitting diode light source is chosen from a fluorescent light source, a polarized white light source, or an unpolarized white light source, at least one loupe mounted on the frame for visually observing the tissue, at least one filter disposed between the tissue and the loupe for filtering light reflected from the tissue, an energy source operably connected to the at least one light- emitting diode light source.
  • the light source may be fluorescent, polarized white light, or unpolarized white light.
  • the camera may be any suitable camera for recording images of tissue under the above mentioned light conditions.
  • the energy source may be any energy source suitable to power the optical device for a desired amount of time.
  • the present disclosure relates to a method for visualizing tissue comprising: illuminating a tissue with at least one light-emitting diode light source chosen from a fluorescent light source, a polarized white light source, and an unpolarized white light source; and observing the tissue after illumination with the at least one light- emitting diode light source.
  • Figure 1 is an example construction of the optical device of the present invention.
  • Figure 2 shows the beam pattern of fluorescence illumination and beam uniformity of the device of the present invention.
  • Figure 3 is floor of mouth images of a normal volunteer captured by the optical device under fluorescence, un-polarized white light reflectance, and polarized white light reflectance.
  • Figure 4 is floor of mouth images of a patient captured by the optical device under fluorescence, un-polarized white light reflectance, and polarized white light reflectance.
  • the present disclosure relates to a device for examining tissue comprising:a frame, at least one light-emitting diode light source mounted on the frame for illuminating a tissue, wherein the at least one light-emitting diode light source is selected from the group consisting of: a fluorescent light source, a polarized white light source, and an unpolarized white light source, at least one loupe mounted on the frame for visually observing the tissue, at least one filter disposed between the tissue and the loupe for filtering light reflected from the tissue, an energy source operably connected to the at least one light-emitting diode light source.
  • the device may also comprise a camera mounted on the frame for capturing images of the tissue or a display monitor operably connected to the camera for receiving a signal produced by the camera.
  • the light source utilized in the device of the present disclosure may be a fluorescent or white light source.
  • Appropriate white light sources include both polarized and unpolarized white light sources.
  • the light sources of the present disclosure are in the form of light-emitting diodes (LEDs) so as to minimize the size, weight, and energy consumption of the device.
  • LEDs light-emitting diodes
  • An example of an LED that may be used in the device of the present disclosure is the Luxeon Royal Blue- K2 LED.
  • An example of a white light source that may be used in the device of the present disclosure is the Heine LoupeLight.
  • the device of the present disclosure may optionally comprise a camera. Suitable cameras for this device include any camera capable of capturing images in a field provided by the fluorescent or polarized or unpolarized white light sources described above.
  • the energy source utilized in the device of the present disclosure can be any energy source capable of supplying energy to the device for an adequate period of time.
  • the energy source is a battery.
  • the energy source is a lithium-ion battery.
  • FIG. 1 An example embodiment of the system of the present invention is shown in Figure 1.
  • the complete system weights only three pounds and consists of a commercially available surgical head-light with loupes (Heine USA Ltd.), light emitting diodes, a remote-head CCD camera (Prosilica EC1380C), and a lithium-ion battery.
  • the 2.5x magnification binocular loupes provided a working distance (WD) of 250mm, field of view (FOV) of 55mm, and depth of field (DOF) of 55mm.
  • WD working distance
  • FOV field of view
  • DOF depth of field
  • the resolution of the loupe was tested with a U.S. Air Force resolution target and up to 4 line pairs per millimeter could be resolved.
  • the head-light system was modified to provide excitation light for fluorescence imaging with a blue LED (Luxeon Royal Blue- K2).
  • the 75OmW rated LED provides a peak irradiance of 15mW/cm "2 at the center of the measurement site with peak intensity at 455nm.
  • An additional light source Heine LoupeLight
  • a rechargeable lithium-ion battery provided with the head-light system was used for powering the light sources and can be used continuously for four hours.
  • the camera was powered and controlled by a laptop computer through an IEEE 1394 Firewire port. Images of objects on the camera were made parfocal with binocular loupes using a focus adjustable c-mount lens.
  • a polarizer was placed in front of the white LED light; an additional polarizer oriented at 90° relative to the first can be placed in the detection light path to remove any specular reflection if desired.
  • the filter and polarizer in the detection path of the camera were placed using a custom designed filter holder. This holder contains three positions to allow different optical components to be easily interchanged during patient examinations in different imaging modes. Since uniformity of light illumination can influence the perceived contrast of measured objects, we characterized the beam pattern of the fluorescence light and white light prior to taking any tissue images.
  • the illumination profile of the portable screening system was measured on a uniform diffusive surface with the integrated CCD camera. In order to avoid interference from ambient light, all images including patient measurements were acquired in a relatively dark room. Images were recorded in a programmed graphical user interface software in Lab View. All imaging measurements on human were taken with prior consent from the subjects and according to a protocol approved by the Institutional Review Board (IRB) at Rice University and MD Anderson Cancer Center.
  • IRS Institutional Review Board
  • beam pattern of the fluorescence illumination across the field of view is represented in grayscale value with white indicating a region of higher light intensity and black indicating no light.
  • the cross-section of the beam pattern is shown in Figure 2b to indicate the uniformity of illumination across the field.
  • the white light illumination was also characterized in a similar fashion and revealed similar beam pattern.
  • Figure 3 shows images of the floor of mouth of a normal subject using different imaging modes of the portable screening system. Although the bright fluorescence signal from the teeth partially saturates the image, green autofluorescence signal from tissue is clearly visible in Figure 3a. Similarly, in the standard white light image (un-polarized), strong specular reflection in some regions partially saturates the image and hinders observation of underlying tissue structures. In comparison, in the cross-polarized image, the specular reflection is removed allowing good visualization of the sub-epithelial structures as shown in Figure 3c.
  • Figure 4 shows images of the floor of mouth in a subject diagnosed with dysplasia in the region.
  • the arrow in the fluorescence image is pointed at an area with strong loss of fluorescence.
  • the un-polarized and polarized white light reflectance images of the same area showed no obvious clinical abnormalities.
  • Both of the white light images show the proposed resection tissue drawn by the surgeon following examination with the PS2 system.
  • Lam S MacAulay C, Hung J, LeRiche A, Prof ⁇ o E, and Palcic B, Detection of dysplasia and carcinoma in situ with a lung imaging fluorescence endoscope device, J. Thorac.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Audiology, Speech & Language Pathology (AREA)
  • Dermatology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)

Abstract

La présente invention, conformément à un mode de réalisation, concerne un dispositif optique pour la visualisation directe, l'imagerie, et des mesures spectroscopiques des anomalies tissulaires au niveau de différents sites anatomiques. De tels sites incluent, mais sans se limiter à cela, la cavité orale, le col de l'utérus, et la peau. Dans un mode de réalisation, le dispositif se compose de : un cadre ; au moins une source lumineuse à diodes émettrices de lumière montée sur le cadre et permettant d'illuminer un tissu, où la au moins une source lumineuse à diodes émettrices de lumière est choisie parmi une source de lumière fluorescente, une source de lumière blanche polarisée, et une source de lumière blanche non polarisée ; au moins une loupe montée sur le cadre et permettant d'observer visuellement le tissu ; au moins un filtre placé entre le tissu et la loupe et permettant de filtrer la lumière réfléchie par le tissu ; une source d'énergie reliée de manière fonctionnelle à la au moins une source lumineuse à diodes émettrices de lumière.
PCT/US2007/071296 2007-06-15 2007-06-15 Système optique d'imagerie de lésions tissulaires Ceased WO2008153569A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US2007/071296 WO2008153569A1 (fr) 2007-06-15 2007-06-15 Système optique d'imagerie de lésions tissulaires
US12/638,459 US20100210951A1 (en) 2007-06-15 2009-12-15 Optical System for Imaging of Tissue Lesions

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/071296 WO2008153569A1 (fr) 2007-06-15 2007-06-15 Système optique d'imagerie de lésions tissulaires

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/638,459 Continuation US20100210951A1 (en) 2007-06-15 2009-12-15 Optical System for Imaging of Tissue Lesions

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Publication Number Publication Date
WO2008153569A1 true WO2008153569A1 (fr) 2008-12-18

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5709459A (en) * 1993-10-08 1998-01-20 Cogent Light Technologies, Inc. Surgical luminaire
US6120161A (en) * 1998-04-08 2000-09-19 Techman International Corporation Video headlight and cable
US20060285316A1 (en) * 2005-06-20 2006-12-21 Welch Allyn, Inc. Hybrid surgical headlight system utilizing dual illumination paths and coaxial optics

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5709459A (en) * 1993-10-08 1998-01-20 Cogent Light Technologies, Inc. Surgical luminaire
US6120161A (en) * 1998-04-08 2000-09-19 Techman International Corporation Video headlight and cable
US20060285316A1 (en) * 2005-06-20 2006-12-21 Welch Allyn, Inc. Hybrid surgical headlight system utilizing dual illumination paths and coaxial optics

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