The present invention relates to accessories for optical human or animal tissue examination instruments, particularly to a coupling and calibration accessory that can be attached to a hand-held optical probe for tissue live examination and pathology. Hereafter, wherever the term “animal” is used in the specification, claims, drawings or abstract, it is intended to and shall encompass non-human animals in the general scientific sense as well as human beings.
Dermoscopy is the examination of skin with an instrument known as a dermoscope to identify skin lesions or other pathology. It is a widely accepted tool for examining the abnormalities of skin conditions including pigmented lesions, especially helpful in diagnostics of various skin cancer conditions. Giuseppe Argenziano et al, “Dermoscopy Improves Accuracy of Primary Care Physicians to Triage Lesions Suggestive of Skin Cancer,” J Clin Oncol 2006; 24:1877-1882. A traditional dermoscope has several components, including a magnifier, a light source that is nonpolarized, a transparent plate and a liquid coupling medium between the dermoscope and the skin. The typical strength of the magnifier is 3×-10×. The dermoscope allows a clinician to observe and analyze skin lesions without the obstruction of skin surface reflections.
Modern dermoscopy has advanced beyond mere magnification to the use of digital imaging techniques that employ multiple illumination wavelengths and polarization orientations, to examine the skin's subsurface features that are not observable merely with the naked eye. Darrell S. Rigel, M D et al. “The Evolution of Melanoma Diagnosis: 25 Years Beyond the ABCDs,” Ca Cancer J Clin 2010; 60:301-316. With the advent of multi-wavelength (sometimes called multispectral) and hyperspectral imaging techniques, more complex dermoscopes have been introduced to capture the skin image formed by diffused light from the illuminated skin at different wavelengths and polarizations.
Skin is generally classified as belonging to certain skin types which are dependent on the kind of melanin present in the tissue and its concentration S. Del Bino, et al., “Relationship between skin response to ultraviolet exposure and skin color type,” 2006 Pigment Cell Res. 19; 606-614. Areas of skin from different body sites also provide a wide range of optical properties (such as absorption and fluorescence) due to their physiological and anatomical characteristics (such as the amounts of melanin, collagen, blood and other components) even within a specific skin type. Different anatomical sites have different conformations which can affect the ability of a measurement device to easily access them. For example, the area next to the nose, ear, or eye is more difficult to access than a broad flat area of the back. Dermoscopes used to examine these different areas of skin need to conform to the site being measured to facilitate accurate observations with acceptable stability. Acceptable stability requires minimal axial, lateral, rotational and angular movement of the dermoscope during the scanning procedure.
Calibration targets are commonly used in reflection-based multispectral and hyperspectral imaging systems to extract the instrument spectral response, including the effect of the light source, detector spectral sensitivity and light transmission properties of system optics. The calibration targets also help to identify spatial variations due to illumination source, transmission optics, or detector characteristics. To maintain high measurement accuracy in multispectral and hyperspectral advanced dermoscopy, the system should be calibrated before the skin examination. However, the varying optical characteristics and unique skin surface of each individual present a calibration challenge in modern multispectral and hyperspectral dermoscopy.
In addition, it is vital that a dermoscope which is used for examination of multiple patients provides a way of ensuring that it is aseptic, i.e. there is no transmission of even trace amounts of any contamination, such as potentially infectious agents, between patients.
The accessory device is a disposable end-cap with a unique identification, a removable calibration target that has responses graduated for various skin types as well as conformations suitable for various anatomical locations.
An end cap for use with a dermoscope having a scope aperture adapted to emit light to illuminate animal tissue and receive light emitted from the tissue in response to illumination of the tissue, and a data processor adapted to process data regarding light emitted from the animal tissue is disclosed. The end cap comprises, a tube having a first end forming a tube aperture adapted to receive light from and transmit light into the scope aperture, and a second end; a calibration target adapted to be removably disposed at the second end of the tube so as to receive light from the dermoscope through the tube aperture and the scope aperture; and an end cap identifier disposed on the end cap so as to uniquely identify the end cap so that the data processor may associate the end cap with data regarding light emitted from tissue of an individual subject and calibration data derived from light received from the calibration target.
A method for calibrating a dermoscope having a scope aperture adapted to emit light to illuminate the animal tissue and receive light emitted from the tissue in response to illumination of the tissue, and a data processor adapted to process data regarding light emitted from the animal tissue is disclosed. The method for calibrating comprises: identifying the skin type of an subject whose skin is to be examined; selecting an end cap corresponding to the skin type of the subject, the end cap having a tube having a first end forming a tube aperture adapted to receive light from and transmit light into the scope aperture, and a second end, and a calibration target adapted to be removably disposed at the end of the tube so as to receive light from the dermoscope through the tube aperture and the scope aperture, the calibration target corresponding to the selected skin type; entering data regarding the optical characteristics of the calibration target into the data processor; and causing the data processor to calibrate the response of the dermoscope to take into account the assumed optical characteristics of the skin based on the optical characteristics of the calibration target.
A method for examining animal tissue to identify lesions is also disclosed. This method comprises providing a dermoscope having a scope aperture adapted to emit light to illuminate a portion of the tissue and receive light emitted from the tissue in response to illumination of the tissue, and a data processor adapted to process data regarding light emitted from the tissue; providing an end cap adapted to be placed on the scope aperture, the end cap having a calibration target and a unique identifier representing the type of end cap and optical characteristics of the calibration target; reading the unique identifier to provide to the data processor the type of end cap and optical characteristics of the calibration target; placing the end cap on the scope aperture; taking one or more measurements of the calibration target; calibrating the dermoscope based on the measurements of the calibration target, the type of calibration target and the optical characteristics of the calibration target; removing the calibration target from the end cap; illuminating the tissue over a plurality of wavelengths and a plurality of polarizations while measuring the reflected illumination light; and based on the preceding measurements of intensity, producing data representative of one or more characteristics of the tissue.
It is to be understood that this summary is provided as a means for generally determining what follows in the drawings and detailed description, and is not intended to limit the scope of the invention. The foregoing and other objects, features, and advantages of the invention will be readily understood upon consideration of the following detailed description taken in conjunction with the accompanying drawings.
Referring to
In general, modern multispectral and hyperspectral dermoscopes collect complex optical data in order to function as medical diagnostic devices. Such instruments need to be calibrated before their use to cancel out variations caused by the instrument performance such as light source variations (e.g., an aging light source) or changing environmental conditions (e.g., room temperature). The instrument should be calibrated with respect to its response as a function of wavelength and polarization of light. The instrument should also be calibrated to take into account any spatial variations across the field of view caused by the instrument, (e.g., brightness variation due to the illumination). After calibration, the data measured will only be dependent on the tissue optical properties.
The accuracy, reliability and safety of such modern dermoscopes can be improved when calibrated with a single-use disposable end-cap that includes a calibration target having optical properties that are optimized according to the patient skin type. The embodiments of the subject end-cap described herein can be used in a variety of multispectral and hyperspectral dermoscopes and are not limited to use with the preferred multimode optical imaging system disclosed in the '910 application.
Referring more specifically to
An elastomeric ring 116 may be provided between end 108 of the tube 102 and the calibration target 112. When the target is removed and the ring 116 is placed against tissue to be examined, the ring both cushions the skin and provides a light-tight seal against the variable skin surface, which, together with the tube 102, acts as a barrier preventing ambient light from entering the illumination and detection paths of the dermoscope. The ring also provides partial compensation for the effect of operator pressure which may deform the examined skin and may reduce slippage of the end cap when placed against the skin, which could otherwise cause image blur or mis-registration. The tube itself can also be shaped to optimize stability and accessibility for skin examination at different anatomical locations.
The removable calibration target 112 is preferably provided with a releasable adhesive 117. The adhesive enables the target to be attached to the second end 108 of the tube, where no elastomeric ring is provided, or to the elastomeric ring 116 when it is provided. Once the dermoscope is calibrated, as discussed below, the calibration target may be removed by pulling it away from the tube, or the ring, so as to break the grip of the adhesive.
The calibration target is mounted on the end-cap with its inner face disposed at approximately the plane where the tissue will be during an examination. Ordinarily, the calibration target will remain in place during the system calibration procedure but will be removed prior to the patient examination. Removal of the calibration target from the end-cap will present an aseptic surface for contact with the patient skin. The purpose of the aseptic surface is to provide a clean sanitary surface for each new patient to assist with infection control and to prevent the transmission of communicable diseases.
It is important for the optical properties of the calibration target to be optimized according to the patient skin type to improve system accuracy as a result of calibration. In dermatology, clinical practitioners classify skin by its appearance into a number of skin types. “Relationship between skin response to ultraviolet exposure and skin color type”, S. Del Bino et al. Pigment Cell Res. 19; 606-614 (2006) Currently there are six commonly accepted skin types from skin type I (white pale skin) to skin type VI (black skin). Each of these skin types can reemit a specific portion of illuminated light due to their specific absorption and scattering properties. To provide the best accuracy for skin examination, the system should be calibrated for the range of remitted light for that skin type. To that end, a number of different types of calibration targets should be provided to obtain the best accuracy and dynamic range for system calibration and skin examination procedures. Preferably at least two calibration target types should be provided and as many as six may be advantageous, but for most purposes it is believed that three calibration targets, namely one target 119 shown by
Referring again to
Turning to
Referring to
The calibration target may vary based on the shape and size of the second end of the end cap tube, i.e., circular and large in this case of end cap 100 or circular and small in the case of end cap 200. Referring now to
In use, the identifier may be manually entered into the data processor of the dermoscope by a keyboard, particularly in the case of a code visible to the human eye. The identifier may be a one or 2D barcode that is scanned by a barcode scanner for input to the processor or a multi-dimensional symbol that is captured by an imaging device. Alternatively, the identifier may be represented by an encoded signal produced by an RFID tag that is attached to the end cap and can be read by an RFID scanner. In another embodiment the identifier may be incorporated in the field of view of the imaging device adjacent to the removable calibration target and the tissue field of view.
The unique identifier 114 or 214 provided with each end-cap is used to inform the system software what type of end-cap and what type of calibration target has been placed on the hand-piece. The identifier allows the system software to recognize the calibration target and adjust the image capture parameters for the calibration and patient measurement procedures based on the type of calibration target being used. For example, type IV skin may require a longer image exposure time at certain wavelengths. The system may also adjust other image capture parameters such as camera gain, dynamic range, or pixel binning.
The identifier 114 or 214 also allows the system software to determine if the end-cap has been previously used or if too much time has elapsed since calibration. If the end-cap has been used, it may be unsanitary and should be discarded. A new end-cap should be used and a new calibration should be performed. If too much time has elapsed since the end-cap was used for calibration, it may have been exposed to ambient contamination, may be unsanitary and should be discarded. A new end-cap should be used and a new calibration be performed. If too much time has elapsed since the end-cap was used for calibration, the calibration may no longer be valid due to the system variations and a new calibration be performed.
The identifier 114 or 214 allows the system software to recognize the shape of the end-cap tube and configure the imaging system accordingly. In some embodiments, the end-cap is shaped to provide enhanced access to a small area of the tissue. When the image is captured, the field of view may be reduced compared to the standard imaging field of view. The system software can adjust the size of image it needs to capture, the speed of acquisition, or the system resolution to provide optimal imaging for the specific anatomical region or for the specific end-cap.
Referring again to
Multimode optical imaging system software in the workstation uses the unique identifier to identify the characteristics of the end-cap and calibration target being used from a database of known characteristics. It then configures the multimode optical imaging system settings, such as field of view, exposure time for each waveband, and the like. The system software then makes calibration measurements on the calibration target to normalize the system response for the type of the skin being imaged. After the calibration procedure, the calibration target will be removed from the end-cap allowing access to the aseptic surface and skin-imaging procedure can begin.
A representative block diagram of a dermoscope system 300 for capturing and processing multimode optical measurements is shown in
The illumination light source 310 may, for example, comprise a Xenon arc lamp incorporated in a spectral programmable light source, such as the product sold under the mark OneLight® Spectra by OneLight Corporation, Vancouver, BC, polarized in only one linear state. The detected light from the tissue sample can be divided into two optical paths comprising cross and parallel polarizations using a beam-splitter and two orthogonally oriented polarizers and each polarization image detected by an individual CCD camera in each path, as will be understood by a person having ordinary skill in the art.
Alternatively, the light emitted from the tissue sample may be spectrally filtered and passed through a polarization selection unit comprising a liquid crystal variable retarder and a linear polarizer that is oriented orthogonally to the illumination polarization. The liquid crystal variable retarder can be controlled to selectively rotate the polarization of the light emitted from the tissue sample prior to passing it through the linear polarizer, such that the fixed linear polarizer can act as a cross, 45 degree, parallel, or any other angle of polarization filter and the signal from each state can be sequentially captured with a single CCD camera.
In
An end-cap of the present invention might also be deployed in a multimode endoscopic measurement delivering hyperspectral light though a light pipe or optical fiber, and receiving emitted light through the same or a separate light pipe or optical fiber. Applicable polarization selection and spectral filtering methods may be selected by a person having ordinary skill in the art.
A dermoscope, such as one including a system 300 as described above, must be calibrated by scanning a reference target to correct illumination inhomogeneities, adjust exposure time for each spectral band to ensure an acceptable signal to noise ratio, subtract the dark current image, remove hot or bad pixel defects from the camera, and store the instrument spectral response characteristics so that the measured tissue optical data become independent of system responses and reflect the true characteristic response of the tissue.
A representative calibration method 370 according to the invention, implemented at step 360 of
The database of the known characteristics may include the shape of the end-cap, the lot number of the components used in the manufacture of the end-cap, the measured reference target response, whether the end-cap has been used before, and other characteristics that may be useful. The dermoscope imaging acquisition system configuration includes adjusting the exposure time, wavelength ranges, polarization settings, illumination power, camera gain, pixel binning, and other similar image acquisition settings. The image validation checks that the image has sufficient brightness for analysis, that the image is not saturated, that the image is not out of focus, that all the images in the image set are captured, that the images are not blurred due to unwanted dermoscope or target movement, that the images are captured within the allowable temperature range and other similar factors. The calibration process produces correction factors that correct for the wavelength dependent response and spatially dependent response for each pixel. These correction factors can be stored in a form of multi-dimensional image data cube.
A multimode multispectral/hyperspectral dermoscope such as the SkinSpect™ multimode imaging system provided by Spectral Molecular Imaging Inc., Beverly Hills, Calif., can combine hyper-spectral, polarization, and autofluorescence imaging modalities to capture images of the skin for analysis.
Referring to
In general, a multimode, multispectral or hyperspectral imaging system may be used with tissues other than the dermis of the skin. For example, the imaging system may be used to examine open wounds, or tissues exposed during the surgery. In such cases, calibration target with different optical properties, such as those corresponding to wounds like chronic ulcers, will be required to maintain optical system accuracy. It is a further object of this invention to provide calibration targets suitable for tissues other than skin. In addition, the end-cap may be used with a dermoscope applied to animals other than a human being.
The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, to exclude equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited by the claims that follow.
Applicants hereby claim the benefit of priority under 35 U.S.C. §120 to Farkas et al. U.S. Provisional Patent Application No. 61/759,910, filed Feb. 1, 2013 and entitled METHOD AND SYSTEM FOR CHARACTERIZING TISSUE IN THREE DIMENSIONS USING MULTIMODE OPTICAL MEASUREMENTS, the contents of which are hereby incorporated by reference in this disclosure.
Number | Date | Country | |
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61846525 | Jul 2013 | US |