A fluorescence device for oral health

Abstract

A fluorescence device for oral health consist of portable device of optical spectroscopy characterized in that software, hardware, light source, camera, touch screen and battery assess oral cavity in situ in real time, non invasively utilizes desired wavelength light to produce fluorescence; analysed said fluorescence and reflectance of oral cavity tissues to detect oral lesions, oral cancer, early cancers or pre-cancerous conditions as well as visual assessment in patients effectively.

Description

[0001] Title of the Invention

[0002] “A Fluorescence Device for Oral Health”

[0003] Field of the Invention

[0004] The present disclosure relates generally to field of medical devices. More specifically the present invention relates to fluorescence device for real -time diagnosis / screening of oral cavity cancer and visual assessment to identify oral lesions to confirm the clinical situations preferably helpful to diagnose oral cancers and early cancers or pre-cancerous alterations noninvasively using fluorescence effect from light source, effectively analysed with GUI software and hardware.

[0005] Background of Invention

[0006] Information from the background discussion that follows could be helpful in comprehending the current invention. It does not imply that any of the data presented here is previous art, pertinent to the invention being claimed at this time, or that any publication, whether explicitly or implicitly.

[0007] The fact that 1.7 million cases are expected to be recorded in 2035 compared to 1 million cases reported in 2012 indicates an increase in cancer occurrences. A significant difficulty is the high mortality, as seen by the 5-year survival rate of less than 45%. In India, the primary causes of this are late diagnosis, a dearth of efficient diagnostic resources in rural regions, and a high frequency of risk factors like pan masala and tobacco use. The International Agency for Research on Cancer (IARC) reported 1.35 lakh new cases and 0.75 lakh deaths from oral cancer in India, making it the second most common cancer worldwide. India has a rapid increase in oral cancer.

[0008] Fluorescence imaging is a type of non-invasive imaging technique that can help visualize biological processes taking place in a living organism. Images can be produced from a variety of methods including: microscopy, imaging probes, and spectroscopy. Fluorescence itself is a form of luminescence that results from matter emitting light of a certain wavelength after absorbing electromagnetic radiation. Molecules that re-emit light upon absorption of light are called fluorophores. Fluorescence imaging photographs fluorescent dyes and fluorescent proteins to mark molecular mechanisms and structures. It allows one to experimentally observe the dynamics of gene expression, protein expression, and molecular interactions in a living cell. It essentially serves as a precise, quantitative tool regarding biochemical applications.

[0009] To ameliorate the current situation of high morbidity and high death rates associated to oral cancer, early and effective diagnosis is required. Conventional Oral Examination (COE), oral cytology, oral brush biopsy, staining (Toluidine Blue, Lugol's Iodine, Methylene Blue), and light-based detection systems are screening techniques used to diagnose oral cancer and pre-cancer stages. The process of tissue biopsy and histological evaluation is used to confirm the diagnosis of mouth cancer. Nevertheless, this process takes a lot of time and is invasive. Determining the affected area is essential to prevent the needless removal of healthy areas.

[0010] Therefore, a non-invasive and efficient screening method is needed prior to biopsy. The different fluorophores that is naturally present in the epithelial lining and submucosa of the oral cavity cause fluorescence when exposed to UV-visible light. The main fluorophores are collagen, tryptophan, nicotinamide adenine dinucleotide (NADH), flavin adenine dinucleotide (FAD), and porphyrin. As the condition worsens, there are variations in three of these fluorophores' concentrations. Because fluorescence-based optical techniques are sensitive to modest morphological and biochemical changes as the disease progresses, they may be used for early cancer diagnosis.

[0011] Over the past few decades, a variety of optical approaches have been employed for the early diagnosis of various types of cancer. Of these, fluorescence spectroscopy has separately emerged as the most successful and has been extensively investigated by researchers. This method is less time-consuming and has good sensitivity and specificity. Due to their high cost and large number of components, these heavy systems appear to be very difficult to transfer from the lab to the clinic or for commercial application. But there isn't a single integrated device that looks at the anomaly in the mouth, scans the affected area, and measures the area at specific points. There is time based need and requirement for the detection of oral cancer can signify a reliable, user-friendly, and reasonably priced device.

[0012] Thus, the present invention relates to an optical spectroscopy based portable device preferably utilizes two types of signals from light source that is fluorescence and reflectance are detected for oral cancer detection and fluorescence imaging of oral cavity tissue in situ for early diagnosis of cancer effectively.

[0013] Object of the Invention

[0014] The primary object of the invention is to develop a portable device using principle of optical spectroscopy based on the principle of optical fluorescence, reflectance and fluorescence imaging to detect and analyze in real time pre cancerous or cancerous lesion in oral cavity and / or asses the clinical situation, in situ with economic significance and devoid of invasion to tissue, biopsy and histopathology.

[0015] The secondary objective of the invention is that the optical spectroscopy device is preferably embodied with Graphic User Interface (GUI) software, hardware, Light Emitting Diode (LED) light source, touch screen, Charge Coupled Device (CCD) camera and battery herein said software analyzes the tissue data through fluorescence and reflectance and automatic acquisition and processing of tissue fluorescence images.

[0016] The another objective of the invention is that the optical spectroscopy analyses the oral cavity within 15 mins non invasively to signify its suitability compare to conventional procedures, herein a predetermine wavelength light is emerging from the device analyses the fluorescence and reflectance of light after diffusing from the tissue effectively from oral cavity without altering and damaging the tissue, further assess in situ normal and abnormal oral tissues.

[0017] Summary of the Invention

[0018] The present invention relates to an optical spectroscopy based portable device preferably utilizes two types of signals from light source that is fluorescence and reflectance are detected and analyzed the data using software to detect oral cancer and fluorescence imaging to detect oral lesions in situ in real time to diagnose cancer at pre cancerous and cancerous stage effectively using GUI software, LED light and CCD Camera.

[0019] A Fluorescence device for oral health comprising of a portable device having size; length of 120 mm, diameter of 40 mm and weight of 140 gm, works on optical spectroscopy preferably operates two diffrenent mehos wherein one method comprises: a light source preferably Light Emitting Diode (LED) light source to emit the desired wavelength, incident on the oral cavity tissues and diffuse through it, the fluorescence and the diffused reflectance analysed from emitted signals converted into spectra separately using a Graphic User Interface (GUI) software configured in hardware, the data analysis displayed on the touch screen works on a conventional battery of laptop or tab to detect oral cancer; while the other method utilizes a Light Emitting Diode (LED) light source to emit the desired wavelength, incident on the oral cavity tissues and the emitted fluorescence from oral cavity tissues analysed from emitted signals detected by Charge Coupled Device (CCD) camera which generates two dimensional fluorescence spectral images automatically processed and interpreted from Graphic User Interface (GUI) software signify real time in situ non invasive visual assessment to identify oral lesions to confirm the clinical situations preferably oral cancers, early cancers or pre-cancerous conditions. One of the preferred embodiments of the present invention is to utilize the desired wavelength non invasively without alerting or damaging the tissue part and analysed the data within 15 min.

[0020] One of the preferred embodiments of the present invention is to utilize the desired wavelength non invasively without alerting or damaging the tissue part and analysed the data within 15 min.

[0021] One of the preferred embodiments of the present invention is GUI software embodied in the housing of the device analyses the data and displays the spectra of fluorescence and reflectance separately on the touch screen of the device.

[0022] One of the preferred embodiments of the present invention is to utilize the desired wavelength using LED light source, incident on oral cavity tissue, herein the fluorescence generated within the tissues, emitted spectral signals, analysed for normal and abnormal fluorescence images.

[0023] One of the preferred embodiments of the present invention is that the emitted fluorescence signals detected through CCD camera, which further process it to generate the fluorescence images, the generated images are evaluated for assessment of clinical situation of oral cavity.

[0024] One of the preferred embodiments of the fluorescence images generated by CCD camera can be automatically processed, developed and integrated using GUI software in real time to identify oral lesions to confirm the clinical situations preferably helpful to diagnose oral cancers, early cancers or pre-cancerous conditions effectively.

[0025] Brief Description of Drawings

[0026] The following thorough explanation of the various aspects of the invention, taken in conjunction with the corresponding drawing that represents various aspects and other features of the disclosure invention. Figure 1 : Flow chart of method (A) to operate the device, to detect oral cancer Figure 2: Flow chart of method (B) for visual assessment, to detect cancerous conditions.

[0027] Detailed Description of the Invention

[0028] The following description is of exemplary embodiments only and is not intended to limit the scope, applicability or configuration of the invention in any way. Rather, the following description provides a convenient illustration through explanation and figures for implementing exemplary embodiments of the invention. Various changes to the described embodiments may be made in the function and arrangement of the ingredients described without departing from the scope of the invention.

[0029] The use of “including”, “comprising” or “having” variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

[0030] A non-invasive and efficient screening method is needed prior to biopsy by utilizing fluorophores that is naturally present in the epithelial lining and sub mucosa of the oral cavity cause fluorescence when exposed to UV-visible light. As fluorescence-based optical techniques are sensitive to modest morphological and biochemical changes as the disease progresses, they may be used for early cancer diagnosis. Over the past few decades, a variety of optical approaches have been employed for the early diagnosis of various types of cancer. Of these, fluorescence spectroscopy has separately emerged as the most successful and has been extensively investigated by researchers. This method is less time-consuming and has good sensitivity and specificity. Due to their high cost and large number of components, these heavy systems appear to be very difficult to transfer from the lab to the clinic or for commercial application. But there isn't a single integrated device that looks at the anomaly in the mouth, scans the affected area, and measures the area at specific points. There is time based need and requirement for the detection of oral cancer can signify a reliable, user-friendly, and reasonably priced device. There is also time based need wherein non-invasive and efficient screening method is needed prior to biopsy by utilizing fluorophores that is naturally present in the epithelial lining and sub mucosa of the oral cavity cause fluorescence when exposed to UV-visible light. As fluorescence-based optical techniques are sensitive to modest morphological and biochemical changes as the disease progresses, they may be used for early cancer diagnosis. .

[0031] Thus, the present invention relates to an optical spectroscopy based portable device preferably utilizes two types of signals from light source that is fluorescence and reflectance are detected and analyzed the data using software to detect oral cancer while the another method relates to fluorescence imaging for real -time visual assessment of oral cavity and to identify oral lesions to confirm the clinical situations preferably oral cancers, early cancers or pre-cancerous conditions.

[0032] A Fluorescence device for oral health comprising of a portable device having size; length of 120 mm, diameter of 40 mm and weight of 140 gm, works on optical spectroscopy preferably operates two diffrenent mehos wherein one method comprises: a light source preferably Light Emitting Diode (LED) light source to emit the desired wavelength, incident on the oral cavity tissues and diffuse through it, the fluorescence and the diffused reflectance analysed from emitted signals converted into spectra separately using a Graphic User Interface (GUI) software configured in hardware, the data analysis displayed on the touch screen works on a conventional battery of laptop or tab to detect oral cancer; while the other method utilizes a Light Emitting Diode (LED) light source to emit the desired wavelength, incident on the oral cavity tissues and the emitted fluorescence from oral cavity tissues analysed from emitted signals detected by Charge Coupled Device (CCD) camera which generates two dimensional fluorescence spectral images automatically processed and interpreted from Graphic User Interface (GUI) software signify real time in situ non invasive visual assessment to identify oral lesions to confirm the clinical situations preferably oral cancers, early cancers or pre-cancerous conditions.

[0033] Preferred embodiments of a fluorescence device for oral cancer i) Main Housing or Hardware: The body of optical spectroscopy device that is hardware having configured with light source, touch screen, CCD camera and software. ii) Light Emitting Diode (LED) light source: LED source is an important source to emit light of desire wavelength to produce fluorescence spectroscopic effect, The optical spectroscopy device uses the LED light source which emits the desired spectroscopic wavelength light that incident at oral cavity. Fluorescence and reflectance is analysed accordingly with usage of software. In anothere application light incident on oral cavity tissue, wherein fluorescence generated within the tissues, emitted spectral signals, analysed for normal and abnormal fluorescence images. iii) Graphic User Interface (GUI) software: GUI software is the preferred embodiment of the present device configured into the housing, analyses or processes the data of emitted fluorescence and reflectance coming from the oral cavity tissues into spectra. The spectra is analysed, documented and reflected on the touch screen. In another application of the device the fluorescence images generated by CCD camera can be automatically processed, developed and integrated using GUI software in real time to identify oral lesions to confirm the clinical situations preferably helpful to diagnose oral cancers, early cancers or pre-cancerous conditions effectively. iv) Touch Screen: One of the preferred embodiment of the present device is touch screen is provided to display the spectroscopic data analysed by the GUI software herein the separate readings of fluorescence and reflectance emitted from oral tissues displayed. The touch screen is user friendly and easy to operate. v) Charge Coupled Device (CCD) camera: The emitted fluorescence signals from the oral cavity tissues are detected through CCD camera, which further process it to generate the fluorescence images, the generated images are evaluated for assessment of clinical situation of oral cavity. vi) Battery: The present device works on the conventional batteries, specifically used in laptops or tabs, embodied into the main housing of the device.

[0034] As the different components of the present device are small in size, enables it to portable from one location to another and easy to operate thereof.

[0035] Table no. 01 : Preferred embodiments of the device

[0036] Steps involved in the method to operate the device i) Locating the oral cavity tissue: The oral cavity tissues to be investigated are located and introduced to spectroscopic light source. ii) Emitting the desired wavelength from LED light and Detecting the images : By switching “On” the switch of the light source, emission of preferred wavelength falls on to the oral cavity tissue, the emitted spectroscopic and diffuse reflectance emission of light comes back to the device for analysis in one application while in another application the oral cavity tissue are exposed to LED light in situ to produce fluorescence effect and emits the spectral signals, said emitted fluorescence spectral signals by oral cavity tissues are detected, processed and converted to generation of fluorescence images using Charge Coupled Device (CCD) camera for the clinical visual assessment and interpretation of normal and abnormal clinical conditions. iii) Automatic processing the emitted spectroscopic signals: Emitted spectroscopic signals from the oral cavity tissue are processed using GUI software, herein the software process, analyse and document the data and reflects by displaying it on the touch screen provided on the device in one application while another application generated fluorescence images from the CCD camera are processed and developed automatically using Graphic User Interface (GUI) software in real time with speedy analysis of images to draw the clinical inference, effectively works from the power of conventional battery of laptop or tab. (Table No. 1 and Figure No. 1 and 2)

[0037] Method to operate the device

[0038] A) Locating the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis, recording both; the emitted fluorescence lights from the oral cavity; and the reflecting light emits after diffusing from the tissue separately, processing and analysing the input data emitted fluorescence and reflectance light from oral cavity tissues form GUI software, herein GUI software analyses the data separately and effectively; displaying the process data of fluorescence and reflectance on the touch screen of the device; documenting and storing the data in software for future use. The optical spectroscopy device works on the power of conventional battery of laptop or tab. The overall investigation is operated from

[0039] 10 to 15 min. . (Table No. 1 and Figure No. 1 )

[0040] B) Emitting the desired wavelength light through Light Emitting Diode (LED), exposed to oral cavity tissue in situ for 10 to 15 min to produce fluorescence effect through emission of spectral signals; detecting the emitted fluorescence spectral signals by oral cavity tissues, processed and generation it into fluorescence images using Charge Coupled Device (CCD) camera for visual assessment and interpretation; processing the generated fluorescence images from the CCD camera which acquire and interpreted, automatically using Graphic User Interface (GUI) software in real time for 10 to 15 min with speedy analysis of images to draw the clinical inference. (Table No. 1 and Figure No. 2 )

[0041] Example 1

[0042] Locating the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis, recording the emitted fluorescence lights from the oral cavity for 10 mins, processing and analysing the input data emitted fluorescence light from oral cavity tissues form GUI software, herein GUI software analyses the data separately and effectively; displaying the process data of fluorescence on the touch screen of the device; documenting and storing the data in software for future use.

[0043] Example 2

[0044] Locating the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis, recording the emitted fluorescence lights from the oral cavity for 15 mins, processing and analysing the input data emitted fluorescence light from oral cavity tissues form GUI software, herein GUI software analyses the data separately and effectively; displaying the process data of fluorescence on the touch screen of the device; documenting and storing the data in software for future use.

[0045] Example 3

[0046] Locating the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis, recording the reflecting light emits after diffusing from the tissue for 10 mins of emitted reflectance light software, herein GUI software analyses the data separately and effectively; displaying the process data of reflectance on the touch screen of the device; documenting and storing the data in software for future use.

[0047] Example 4

[0048] Locating the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis, recording the reflecting light emits after diffusing from the tissue for 15 mins of emitted reflectance light software, herein GUI software analyses the data separately and effectively; displaying the process data of reflectance on the touch screen of the device; documenting and storing the data in software for future use.

[0049] Example 5

[0050] Emitting the desired wavelength light through Light Emitting Diode (LED), exposed to oral cavity tissue in situ for 10 min to produce fluorescence effect through emission of spectral signals; detecting the emitted fluorescence spectral signals by oral cavity tissues, processed and generation it into fluorescence images using Charge Coupled Device (CCD) camera for visual assessment and interpretation in real time to draw the clinical inference.

[0051] Example 6

[0052] Emitting the desired wavelength light through Light Emitting Diode (LED), exposed to oral cavity tissue in situ for 10 min to produce fluorescence effect through emission of spectral signals; detecting the emitted fluorescence spectral signals by oral cavity tissues, processed and generation it into fluorescence images using Charge Coupled Device (CCD) camera for visual assessment and interpretation; processing the generated fluorescence images from the CCD camera which acquire and interpreted, automatically using Graphic User Interface (GUI) software in real time with speedy analysis of images to draw the clinical inference.

[0053] Example 7

[0054] Emitting the desired wavelength light through Light Emitting Diode (LED), exposed to oral cavity tissue in situ for 15 min to produce fluorescence effect through emission of spectral signals; detecting the emitted fluorescence spectral signals by oral cavity tissues, processed and generation it into fluorescence images using Charge Coupled Device (CCD) camera for visual assessment and interpretation in real time to draw the clinical inference.

[0055] Example 8

[0056] Emitting the desired wavelength light through Light Emitting Diode (LED), exposed to oral cavity tissue in situ for 15 min to produce fluorescence effect through emission of spectral signals; detecting the emitted fluorescence spectral signals by oral cavity tissues, processed and generation it into fluorescence images using Charge Coupled Device (CCD) camera for visual assessment and interpretation; processing the generated fluorescence images from the CCD camera which acquire and interpreted, automatically using Graphic User Interface (GUI) software in real time with speedy analysis of images to draw the clinical inference.

[0057] Scope of the Invention

[0058] Fluorescence spectroscopy has separately emerged as the most successful and has been extensively investigated by researchers. This method is less time-consuming and has good sensitivity and specificity. The present portable fluorescence device preferably real time assess oral cavity in situ, non invasively, further locates the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis, recording the reflecting light emits after diffusing from the tissue for 15 mins of emitted reflectance of light, herein GUI software analyses the data separately and effectively; displaying the process data of reflectance on the touch screen of the device; documenting and storing the data in software for future use while another application of the device which utilizes desired wavelength light from LED to produce fluorescence emitted through oral cavity tissues detected and identified using CCD cameras and GUI software for clinical visual assessment of oral cavity preferably oral cancers, early cancers or pre-cancerous conditions in patients effectively in future.

[0059] It is to be understood that the present invention is not limited to the embodiments described above, it should be clear that various modifications and alterations can be made along with various features of one embodiment included in other embodiments, within the scope of the present invention.

Claims

We claim,1- A Fluorescence device for oral health comprising a portable device of optical spectroscopy characterized in that a Graphic User Interface (GUI) software; a hardware; a Light Emitting Diode (LED) light source; a touch screen, a Charge Coupled Device (CCD) camera and a battery effectively analysed fluorescence and reflectance of oral cavity tissues and fluorescence images for visual assessment to detect oral lesions, oral cancers and early pre cancerous and cancerous conditions.2- The fluorescence device for oral health as claimed in claim 1, having size; length of 120 mm, diameter of 40 mm and weight of 140 gm.3- The fluorescence device for oral health as claimed in claim 1, operates through a method to detect oral cancer comprises the following steps: i) Locating the oral cavity of the investigational personnel, the espoused oral cavity tissues are introduced to spectroscopic light emission of desired wavelength of analysis; ii) recording both, the emitted fluorescence lights from the oral cavity and the reflecting light emits after diffusing from the tissue separately; iii) processing and analysing the input data emitted fluorescence and reflectance light from oral cavity tissues form GUI software, herein GUI software analyses the data separately and effectively; iv) displaying the process data of fluorescence and reflectance on the touch screen of the device; and v) documenting and storing the data in software for future use.4- The fluorescence device for oral health as claimed in claim 1, operates through a method to generate fluorescence images in situ for visual assessment of oral lesions, pre-cancerous and cancerous comprises the following steps:i) emitting the desired wavelength light through Light Emitting Diode (LED), exposed to oral cavity tissue in situ to produce fluorescence effect through emission of spectral signals; ii) detecting the emitted fluorescence spectral signals by oral cavity tissues, processed and generation it into fluorescence images using Charge Coupled Device (CCD) camera for visual assessment and interpretation; iii) processing the generated fluorescence images from the CCD camera which acquire and interpreted, automatically using Graphic User Interface (GUI) software in real time for 10 to 15 min with speedy analysis of images to draw the clinical inference.

Images