Description:1
FORM 2
THE PATENTS ACT 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
AN AUTOMATIC DEVICE FOR DETECTING TEAR FERNING
2. APPLICANT
GD Goenka University,
Sohna Gurugram Road,
Sohna, Haryana, India, 122103
(i) PREAMBLE TO THE DESCRIPTION
COMPLETE
The following specification particularly describes the invention and the manner in which it is to be performed.
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AN AUTOMATIC DEVICE FOR DETECTING TEAR FERNING TECHNICAL FIELD
[0001] The present invention relates to an automatic device for detecting tear ferning patterns, for the diagnosis of dry eye conditions. Most particularly, the invention provides a non-invasive, compact, and portable solution to evaluate tear 5 film quality through high-resolution imaging and automated analysis in clinical settings.
BACKGROUND
[0002] The analysis of tear ferning patterns has become an increasingly important method in understanding the quality and health of the tear film, which plays a 10 crucial role in maintaining ocular surface integrity. Tear ferning refers to the formation of crystal-like structures when a tear sample is allowed to dry on a surface. The presence, shape, and distribution of these crystalline structures provide valuable insights into the composition and overall stability of the tear film. This approach has been utilized for decades to diagnose dry eye syndrome (DES), a 15 condition that affects millions of people worldwide. The significance of detecting tear ferning patterns lies in its non-invasive nature, cost-effectiveness, and ability to provide detailed information regarding ocular health.
[0003] Despite its usefulness, the current state of technology for detecting tear ferning patterns relies heavily on manual observation and subjective assessment by 20 specialists. Typically, the process involves collecting a tear sample, drying it on a glass slide, and observing the crystal patterns under a standard light microscope. This method depends largely on the skills and experience of the examiner, leading to inconsistencies in interpretation and classification. Moreover, the manual process can be both time-consuming and prone to human error, reducing reliability and 25 repeatability across different practitioners. Consequently, there is a pressing need for improved tools that can provide objective, accurate, and real-time analysis of tear ferning patterns to support better diagnostic outcomes.
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[0004] One of the key drawbacks of existing technology is the subjective nature of tear ferning pattern classification. In the traditional method, the morphological patterns of tear ferning are classified into four grades, ranging from Type I (well-formed ferning with a regular branching pattern) to Type IV (no discernible fern-like structures). The classification of these patterns is typically carried out by an 5 ophthalmologist or technician, based solely on visual inspection under a microscope. As a result, this subjective evaluation can vary widely between different observers, leading to significant discrepancies in diagnosis. This lack of standardization is a considerable barrier to the widespread adoption of tear ferning analysis as a reliable diagnostic tool, especially for large-scale studies or routine 10 clinical applications.
[0005] Another major issue is the labor-intensive and cumbersome nature of the tear sample preparation and analysis process. The requirement for tear sample collection, slide preparation, drying time, and microscopic examination adds several layers of complexity to what could be an otherwise straightforward 15 diagnostic procedure. Tear sample collection itself is a delicate process, often requiring the use of capillary tubes or Schirmer’s strips to gather sufficient fluid. Any error in handling can lead to the contamination or loss of the sample, affecting the quality and accuracy of the results. Additionally, the drying process of the tear film is influenced by numerous environmental factors such as temperature and 20 humidity, which can further impact the reproducibility of ferning patterns. These variables make it difficult to establish a consistent protocol for tear ferning analysis across different settings.
[0006] Moreover, the existing methods of detecting and analyzing tear ferning patterns lack technological integration that could enhance accuracy and 25 accessibility. The use of standard microscopes and manual grading means that the entire process must be performed in a clinical setting by a trained professional, which limits accessibility, particularly in rural or underserved areas. Patients often need to schedule separate visits to specialized clinics or laboratories, leading to delays in diagnosis and treatment. Furthermore, the lack of advanced image 30
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capturing and processing capabilities means that a detailed digital archive of tear patterns is rarely maintained, restricting opportunities for longitudinal studies or comparative analysis over time. This results in missed opportunities for advancements in understanding tear film dynamics and for developing tailored treatment strategies for dry eye conditions. 5
[0007] Recent advancements in imaging technology and artificial intelligence (AI) provide an opportunity to address the drawbacks of traditional methods. The integration of automated image processing techniques and machine learning algorithms has the potential to standardize tear ferning analysis, reducing subjectivity and improving accuracy. For instance, using high-resolution digital 10 imaging combined with AI-based pattern recognition can enable the objective classification of tear fern patterns. Automated systems can be trained on large datasets of annotated images to recognize different ferning types and provide consistent results, irrespective of who operates the system. This level of consistency is crucial for making tear ferning a more universally accepted diagnostic technique 15 for dry eye disease and other ocular surface disorders.
[0008] Another approach to modernizing tear ferning analysis involves the development of portable and easy-to-use devices that can be used in various healthcare settings, including primary care clinics and even patients' homes. The integration of sensors and compact imaging devices in a portable platform can 20 facilitate point-of-care diagnostics, allowing quicker screening and monitoring of tear film health. Such devices could include a sample collection mechanism, automated drying under controlled environmental conditions, and an integrated imaging system capable of capturing high-resolution images of the dried tear sample. By incorporating user-friendly interfaces and connectivity features, such 25 devices could help bridge the gap between specialized clinical diagnostics and general healthcare services, providing timely insights into patients' ocular health.
[0009] Additionally, modern optical techniques, such as polarized light microscopy or fluorescence imaging, can enhance the visibility and contrast of tear ferning
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patterns, leading to improved detection sensitivity. By using these advanced imaging modalities, the subtle structural differences between various types of ferning can be more clearly observed, enabling more accurate differentiation between healthy and pathological tear samples. These techniques, when combined with digital image processing, can produce a comprehensive set of quantitative 5 features that can be used for further analysis and classification. Such innovations would not only improve the reliability of tear ferning analysis but also enable a more detailed understanding of tear composition, offering insights into the underlying causes of dry eye syndrome and related conditions.
[0010] While tear ferning analysis holds considerable promise as a diagnostic tool 10 for evaluating tear film quality, the current methods suffer from significant drawbacks, including subjectivity, labor-intensive procedures, and limited technological integration.
[0011] Thus, addressing these problems, the proposed an automatic device for detecting tear ferning patterns addresses traditional challenges by automating the 15 detection process with a high-resolution camera, microscope with auto-focus, and advanced image processing algorithms, ensuring consistent and objective results. Its compact, portable design makes it accessible for use in various clinical settings. An adjustable lighting system provides optimal illumination, improving image clarity. Real-time image processing allows immediate analysis and feedback, 20 expediting diagnosis. Built-in data logging capabilities facilitate longitudinal monitoring of tear health, aiding in personalized patient care and effective management of dry eye conditions.
OBJECTIVE OF THE INVENTION
[0012] The present invention has been developed in response to the present state of 25 the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available techniques and processes.
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[0013] Accordingly, the present invention pertains an automatic device for detecting tear ferning patterns, for the diagnosis of dry eye conditions. Most particularly, the invention provides a non-invasive, compact, and portable solution to evaluate tear film quality through high-resolution imaging and automated analysis in clinical settings. 5
[0014] The yet one more object of present invention has been developed a device to ensure consistent and objective results by eliminating manual observation and interpretation.
[0015] Therefore, the current invention successfully overcoming all the above-discussed shortcomings present in the art. 10
[0016] The main object of the present invention is to develop the device to improve the sterilization process to effectively eliminate harmful microorganisms, reducing the risk of eye infections.
[0017] The main object of the present invention is to develop the device to design a compact and portable device for use in diverse clinical environments. 15
[0018] The main object of the present invention is to develop the device to integrate an adjustable lighting system for optimal sample illumination, enhancing image quality.
[0019] Another object of the present invention is to develop the device to provide real-time image processing and analysis for immediate feedback and faster 20 diagnosis.
[0020] The main object of the present invention is to develop the device to include data logging capabilities to enable longitudinal monitoring and personalized treatment planning for dry eye management.
[0021] The main object of the present invention is to develop the device to enhance 25 accessibility of tear ferning analysis in both urban and rural healthcare settings.
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[0022] The main object of the present invention is to develop the device to improve diagnostic accuracy by utilizing advanced image processing algorithms and high-resolution imaging.
[0023] How the foregoing objects are achieved will be clear from the following brief description. In this context, it is clarified that the description provided is non-5 limiting and is only by way of explanation. Other objects and advantages of the invention will become apparent as the foregoing description proceeds, taken together with the accompanying drawings and the appended claims.
SUMMARY
[0024] This summary is provided to introduce a selection of concepts in a 10 simplified format that is further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention and nor is it intended for determining the scope of the invention.
[0025] According to an aspect of the present invention relates to an automatic 15 device for detecting tear ferning patterns for the diagnosis of dry eye conditions comprises a housing configured with a glass slab holder, which is adapted to hold a glass microscope slide containing a tear fluid sample. The device includes an adjustable lighting module configured to the housing, which provides consistent illumination to the tear sample on the slide. A microscope unit with an automatic 20 focusing module is integrated to magnify the tear ferning patterns formed on the slide, and a high-resolution imaging unit is used to capture these images. The device also features an image processor, configured within the housing, that analyzes the captured images by employing pattern recognition techniques and classifying the tear ferning patterns into predefined grades. A display unit is provided for 25 presenting the captured images, analysis results, and to serve as an interactive user interface for clinicians. Additionally, a data logging unit is included for storing captured images, analysis results, and diagnostic history. The power supply unit is
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configured within the housing to provide the necessary power, and a USB unit is provided for data transfer between the device and external systems.
[0026] In an aspect of the invention, the glass slab holder is holding the glass microscope slide in a stable position during the drying and imaging process, to prevent movement or vibration. 5
[0027] In an aspect of the invention, the adjustable lighting module allows adjustments in brightness and angle to ensure optimal visibility of the tear ferning patterns under varying ambient lighting conditions.
[0028] In an aspect of the invention, the microscope unit is configured to provide automatic focusing to ensure sharp image clarity for detailed analysis of the tear 10 ferning patterns.
[0029] In an aspect of the invention, the high-resolution imaging unit is adjustable focus settings to enable the capture of precise images of microstructural details in the tear ferning pattern.
[0030] In an aspect of the invention, the image processor is configured to classify 15 the tear ferning patterns into grades from 1 to 4 based on the density, branching, and gaps of the crystallized tear ferning structures.
[0031] In an aspect of the invention, the display unit includes a zoom feature that allows a clinician to zoom in on specific areas of the tear ferning pattern for closer inspection. 20
[0032] In an aspect of the invention, further comprising a report generation module configured to generate a comprehensive diagnostic report that includes the captured image, the ferning pattern classification grade, and recommendations for treatment or further testing.
[0033] Accordingly, a method of diagnosing dry eye conditions involves several 25 key steps. First, a tear fluid sample is collected from the patient's lower eyelid and
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placed on a clean, sterile glass microscope slide, which is then inserted into the glass slab holder of the device. The tear fluid sample is allowed to dry under ambient conditions. Next, the dried tear fluid sample is illuminated using the adjustable lighting unit to enhance visibility. High-resolution images of the tear ferning patterns are captured with the microscope unit and high-resolution imaging 5 unit. These captured images are then processed by the image processor to analyze and classify the ferning patterns. The results, along with the captured images, are displayed on the display unit for the clinician's review. A comprehensive diagnostic report is generated, including the image of the ferning pattern, the classification grade, and any additional notes or recommendations. Finally, the captured images 10 and analysis results are transferred using the USB unit for further analysis or integration into electronic health records.
[0034] To further clarify the advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is 15 appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS 20
[0035] The accompanying drawings, which are incorporated herein, and constitute a part of this disclosure, illustrate exemplary embodiments of the disclosed methods and devices in which like reference numerals refer to the same parts throughout the different drawings. Components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present 25 disclosure. Some drawings may indicate the components using block diagrams and may not represent the internal circuitry of each component. It will be appreciated by those skilled in the art that disclosure of such drawings includes disclosure of
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electrical components, electronic components or circuitry commonly used to implement such components.
Figure 1 illustrates a block diagram of an automatic device for detecting tear ferning patterns in accordance with an embodiment of the invention; and
Figure 2 illustrates an isometric view of the lens sterilization and storage device in 5 accordance with an embodiment of the invention.
Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have been necessarily been drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help to improve understanding of aspects of the present invention. Furthermore, 10 in terms of the construction of the device, one or more components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having 15 benefit of the description herein.
DETAILED DESCRIPTION OF EMBODIMENTS
[0036] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will 20 nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. 25
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[0037] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are explanatory of the invention and are not intended to be restrictive thereof.
[0038] Reference throughout this specification to “an aspect”, “another aspect” or similar language means that a particular feature, structure, or characteristic 5 described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
[0039] The terms "comprise", "comprising", or any other variations thereof, are 10 intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises... a" does not, without more constraints, preclude the existence of other 15 devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.
[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skilled in the art to 20 which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.
[0041] 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.
[0042] The terms “having”, “comprising”, “including”, and variations thereof 25 signify the presence of a component.
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[0043] Embodiments of the present invention will be described below in detail with reference to the accompanying drawings.
[0044] The burgeoning field of ocular health management demands innovative solutions to diagnose and monitor conditions like dry eye syndrome. Traditional diagnostic approaches often fall short in providing the precision and detail required 5 for effective treatment planning. As such, an automatic device designed to detect tear ferning patterns has emerged as a pivotal advancement in ophthalmic diagnostics. This device integrates multiple sophisticated components to facilitate accurate detection and analysis of tear fluid samples, ultimately enhancing the clinician's ability to diagnose and manage dry eye conditions effectively. 10
[0045] Referring to Figure 1 illustrates, an automatic device for detecting tear ferning patterns for the diagnosis of dry eye conditions. The automatic device comprises lies a housing that accommodates several critical components, each serving a distinct purpose in the diagnostic process. The housing is configured with a glass slab holder, which is specifically designed to securely hold a glass 15 microscope slide containing a tear fluid sample. This design is paramount for ensuring the stability of the slide during both the drying and imaging processes, thereby preventing any unintended movement or vibration that could compromise the integrity of the captured images. This stability is crucial for maintaining the accuracy of diagnostic results, as even minor shifts in the sample position could 20 lead to misinterpretation of tear ferning patterns.
[0046] Equipped with an adjustable lighting module, the device can provide consistent illumination to the tear sample on the slide. This feature is particularly valuable in clinical settings where ambient light conditions can vary significantly. The adjustable lighting module allows for modifications in both brightness and 25 angle, ensuring optimal visibility of the tear ferning patterns under different lighting conditions. By providing clinicians with a reliable means of illuminating samples, the device enhances the clarity of the visual data, facilitating the identification of subtle characteristics that may indicate varying degrees of dry eye severity.
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[0047] The microscope unit is another integral component of this diagnostic device, equipped with an automatic focusing module that enables the magnification of tear ferning patterns formed on the slide. Automatic focusing technology is a significant advancement that alleviates the need for manual adjustments, thereby streamlining the imaging process and ensuring that clinicians can obtain sharp images with 5 minimal effort. This feature is particularly beneficial in a busy clinical environment, where time efficiency is paramount. Furthermore, the high-resolution imaging unit complements the microscope unit by capturing detailed images of the tear ferning patterns. The ability to adjust focus settings allows for the capture of precise images that reveal microstructural details critical for assessing tear film stability. 10
[0048] The imaging technology employed in this device serves as a powerful diagnostic tool, enabling clinicians to discern intricate details within tear ferning patterns that may be indicative of underlying ocular surface conditions. The integration of high-resolution imaging is essential in providing a comprehensive view of tear film integrity, which is vital for accurately diagnosing dry eye 15 syndrome. By leveraging advanced imaging capabilities, the device equips clinicians with the necessary tools to evaluate tear film stability thoroughly and accurately.
[0049] Once images are captured, they undergo analysis through an integrated image processor designed to perform pattern recognition and classification of the 20 tear ferning patterns. This processor is configured to classify patterns into predefined grades, ranging from 1 to 4, based on criteria such as density, branching, and gaps within the crystallized tear ferning structures. This systematic classification not only standardizes the diagnostic approach but also allows for a nuanced understanding of tear film stability. By employing sophisticated 25 algorithms, the image processor aids clinicians in identifying subtle variations in tear ferning patterns that might be overlooked in traditional assessment methods.
[0050] This objective classification device enhances the clinician's ability to diagnose dry eye conditions accurately and consistently. The incorporation of
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pattern recognition algorithms serves to minimize subjective interpretation, providing a reliable basis for clinical decision-making. The ability to classify tear ferning patterns systematically supports the development of personalized treatment plans tailored to each patient's specific condition, ultimately improving patient outcomes. 5
[0051] The user-friendly display unit of the device is designed to present captured images alongside analysis results, providing clinicians with a comprehensive overview of the diagnostic data. This interactive user interface enables clinicians to zoom in on specific areas of the tear ferning pattern for closer inspection, facilitating detailed analysis of critical features within the sample. The zoom feature 10 is particularly beneficial for examining fine details that may influence diagnosis and treatment recommendations. By allowing clinicians to engage with the visual data dynamically, the display unit enhances the interpretive capabilities of the device, ultimately contributing to more informed clinical decisions.
[0052] In addition to imaging and analysis, the device is equipped with a data 15 logging unit that stores captured images, analysis results, and the diagnostic history of patients. This functionality ensures that critical information is readily accessible for future reference, promoting continuity of care and enabling clinicians to track changes in a patient's condition over time. Such historical data is invaluable for monitoring the effectiveness of treatment plans and making necessary adjustments 20 based on patient response.
[0053] Moreover, the device features a report generation module that compiles comprehensive diagnostic reports, including captured images, classification grades of the ferning patterns, and tailored recommendations for treatment or further testing. The ability to generate detailed reports not only streamlines documentation 25 but also enhances communication between clinicians and patients. These reports can serve as a basis for discussions regarding treatment options, fostering collaborative decision-making that prioritizes patient needs.
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[0054] The reliable operation of the device is supported by a power supply unit integrated into the housing, ensuring that all components function seamlessly during clinical assessments. Additionally, the inclusion of a USB unit facilitates data transfer, allowing clinicians to export captured images and analysis results easily. This feature enhances workflow efficiency within clinical settings by 5 promoting effective data sharing and enabling integration into electronic health records (EHR). The capacity for data transfer ensures that critical diagnostic information is readily available for further evaluation or collaboration among healthcare providers.
[0055] The automatic device for detecting tear ferning patterns represents a 10 significant advancement in the diagnostic assessment of dry eye conditions. By integrating sophisticated imaging technology, automatic analysis, and user-friendly interfaces, the device enhances the clinician's ability to evaluate and diagnose ocular health issues accurately. Its comprehensive approach not only streamlines the diagnostic process but also empowers clinicians with the necessary tools to 15 deliver high-quality, evidence-based care. As the understanding of dry eye syndrome continues to evolve, such innovative diagnostic technologies will play an essential role in improving patient outcomes and advancing the standard of care in ophthalmology. This device stands as a testament to the potential for technological innovation to transform clinical practice, ultimately enhancing the quality of life 20 for patients suffering from dry eye conditions.
[0056] Referring to Figure 2, illustrates a method method commences with the collection of a tear fluid sample from a patient’s lower eyelid. This step is crucial, as the quality and integrity of the tear sample directly influence the diagnostic outcomes. By collecting the tear fluid from the lower eyelid, the clinician can 25 ensure a more representative sample of the patient’s tear film, which is essential for accurate analysis. The method emphasizes the importance of sterile technique to prevent contamination, which could lead to erroneous results. This attention to detail underscores the method's commitment to achieving reliable and reproducible diagnostic outcomes. 30
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[0057] Following sample collection, the tear fluid is placed on a clean, sterile glass microscope slide, which is then inserted into a glass slab holder. This holder is specifically designed to maintain the stability of the slide during the subsequent steps of the process, thereby minimizing the risk of movement or vibration that could compromise the integrity of the sample. The use of a clean and sterile 5 environment is paramount, as it prevents external variables from affecting the tear sample, ensuring that the results reflect the patient’s true ocular condition. The method further involves drying the tear fluid sample under ambient conditions. This drying process is critical for the formation of tear ferning patterns, which are indicative of the tear film's stability and quality. By allowing the tear fluid to dry 10 naturally, the clinician can promote the crystallization of the sample, which is essential for subsequent analysis. The ambient drying process also eliminates the potential artifacts that might arise from accelerated drying techniques, such as the application of heat or forced air. This careful approach ensures that the resulting ferning patterns accurately represent the underlying physiological conditions of the 15 tear film.
[0058] Once dried, the tear fluid sample is illuminated using an adjustable lighting unit. The ability to adjust brightness and angle of illumination is crucial in optimizing the visibility of the tear ferning patterns, particularly under varying ambient lighting conditions that may be present in clinical environments. This step 20 ensures that the clinician can clearly observe the crystallized structures formed within the dried tear sample, facilitating accurate image capture and analysis.
[0059] Capturing high-resolution images of the tear ferning patterns is the next critical step in the diagnostic method. Utilizing a microscope unit combined with a high-resolution imaging unit, the clinician can obtain detailed images that reveal 25 the microstructural features of the tear ferning patterns. The precision of this imaging technology is vital for detecting subtle variations that could indicate different severities of dry eye syndrome. By employing advanced imaging techniques, the method provides clinicians with the tools necessary to discern intricate details within the tear film, enhancing their ability to diagnose and classify 30
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dry eye conditions accurately. After capturing the images, the next phase involves processing the captured data using an integrated image processor. This processor analyzes the tear ferning patterns, employing algorithms designed to classify them based on predefined criteria. This classification process is essential for standardizing the diagnostic approach, enabling the clinician to categorize tear 5 ferning patterns into distinct grades indicative of tear film stability. By utilizing objective metrics for classification, the method minimizes subjective interpretation, providing a reliable framework for clinical decision-making.
[0060] The processed images and analysis results are then displayed on a dedicated display unit, designed to facilitate clinician review. This unit includes a zoom 10 feature that allows the clinician to closely inspect specific areas of the tear ferning pattern, promoting a thorough evaluation of critical features within the sample. The interactive nature of the display enhances the clinician's ability to engage with the diagnostic data actively, ultimately leading to more informed clinical judgments. This emphasis on user interface design reflects the method's commitment to 15 enhancing clinical workflows and improving patient outcomes.
[0061] Following image review, the method culminates in the generation of a comprehensive diagnostic report. This report includes the captured image of the ferning pattern, the corresponding classification grade, and any additional notes or recommendations for treatment or further testing. The report generation module 20 streamlines documentation, ensuring that critical diagnostic information is effectively communicated and easily accessible for ongoing patient management. Such thorough reporting not only aids in treatment planning but also fosters effective communication between clinicians and patients, enhancing the overall quality of care. 25
[0062] To further facilitate the integration of diagnostic results into clinical practice, the method includes a USB unit for transferring captured images and analysis results. This capability allows for seamless data sharing between devices, enabling clinicians to conduct additional analyses or incorporate findings into
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electronic health records (EHR). The ability to transfer diagnostic data enhances clinical efficiency and supports continuity of care, as clinicians can readily access and review patient history and previous diagnostic results. This integration of diagnostic information into EHR systems represents a significant advancement in ocular health management, as it allows for comprehensive tracking of patient 5 outcomes and treatment effectiveness over time.
[0063] The method of diagnosing dry eye conditions outlined herein offers a systematic and comprehensive approach that enhances the accuracy and efficiency of clinical diagnostics. By integrating advanced imaging technology with rigorous sample collection and analysis protocols, this method provides clinicians with the 10 tools necessary to effectively diagnose and manage dry eye syndrome. The emphasis on detailed reporting and seamless data transfer further supports the method’s clinical utility, fostering improved patient outcomes and more informed treatment decisions. As the understanding of dry eye conditions continues to evolve, the implementation of such innovative diagnostic methods will be essential 15 in advancing the standard of care in ophthalmology. This method not only addresses current diagnostic challenges but also positions clinicians to deliver high-quality, evidence-based care tailored to the unique needs of each patient suffering from dry eye conditions.
[0064] While certain present preferred embodiments of the invention have been 20 illustrated and described herein, it is to be understood that the invention is not limited thereto. Clearly, the invention may be otherwise variously embodied, and practiced within the scope of the following claims.
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Claims
WE CLAIM:
1. An automatic device (100) for detecting tear ferning patterns for the diagnosis of dry eye conditions, comprising:
a housing configured with a glass slab holder adapted to hold a glass 5 microscope slide containing a tear fluid sample;
an adjustable lighting module (102) configured to the housing to provide consistent illumination to the tear sample on the slide;
a microscope unit (103), including an automatic focusing module, configured to magnify the tear ferning patterns formed on the slide; 10
a high-resolution imaging unit (101) configured to the housing to capture images of the tear ferning patterns;
an image processor (104) configured to the housing to analyze the captured images of the tear ferning patterns, wherein the analysis includes pattern recognition and classification of the tear ferning patterns into 15 predefined grades;
a display unit (105) configured to housing to present the captured tear ferning images, the analysis results, and provide an interactive user interface for clinicians;
a data logging unit (112) for storing captured images, analysis 20 results, and diagnostic history;
a power supply unit configured to the housing to provide power to the housing; and
a USB unit configured to housing for data transfer between the device and external devices. 25
2. The device (100) as claimed in claim 1, wherein the glass slab holder is holding the glass microscope slide in a stable position during the drying and imaging process, to prevent movement or vibration.
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3. The device (100) as claimed in claim 1, wherein the adjustable lighting module (102) allows adjustments in brightness and angle to ensure optimal visibility of the tear ferning patterns under varying ambient lighting conditions.
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4. The device (100) as claimed in claim 1, wherein the microscope unit (103) is configured to provide automatic focusing to ensure sharp image clarity for detailed analysis of the tear ferning patterns.
5. The device (100) as claimed in claim 1, wherein the high-resolution imaging 10 unit (101) is adjustable focus settings to enable the capture of precise images of microstructural details in the tear ferning pattern.
6. The device (100) as claimed in claim 1, wherein the image processor (104) is configured to classify the tear ferning patterns into grades from 1 to 4 15 based on the density, branching, and gaps of the crystallized tear ferning structures.
7. The device (100) as claimed in claim 1, wherein the display unit (105) includes a zoom feature that allows a clinician to zoom in on specific areas 20 of the tear ferning pattern for closer inspection.
8. The device (100) as claimed in claim 1, further comprising a report generation module configured to generate a comprehensive diagnostic report that includes the captured image, the ferning pattern classification 25 grade, and recommendations for treatment or further testing.
9. A method (200) of diagnosing dry eye conditions, comprising:
collecting (201) a tear fluid sample from a patient's lower eyelid;
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placing (202) the tear fluid sample on a clean, sterile glass microscope slide and inserting the slide into the glass slab holder;
drying (203) the tear fluid sample under ambient conditions;
illuminating (204) the dried tear fluid sample using the adjustable lighting unit; 5
capturing (205) high-resolution images of the tear ferning patterns using the microscope unit and high-resolution imaging unit;
processing (206) the captured images using the image processor to analyze and classify the ferning patterns;
displaying (207) the captured images and the analysis results on the 10 display unit for review by the clinician;
generating (208) a comprehensive diagnostic report including the image of the ferning pattern, the classification grade, and additional notes or recommendations; and
transferring (209) the captured images and analysis results to using 15 USB unit for additional analysis or integration into electronic health records.
20 Dated this 30-09-2024
GD Goenka University,
AGENT OR APPLICANT(s) NAME AND SIGNATURE
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ABTRACT AN AUTOMATIC DEVICE FOR DETECTING TEAR FERNING
The present invention relates to an automatic device designed for detecting tear ferning patterns to diagnose dry eye conditions. It features a housing with a glass slab holder specifically adapted to hold a microscope slide containing a tear fluid 5 sample. An adjustable lighting module ensures consistent illumination of the sample. The device includes a microscope unit with an automatic focusing module for magnifying the tear ferning patterns and a high-resolution imaging unit to capture images of these patterns. To enhance diagnostic accuracy, an image processor analyzes the captured images using pattern recognition, classifying the 10 tear ferning patterns into predefined grades. A display unit presents the images and analysis results, providing an interactive user interface for clinicians. Additionally, a data logging unit stores images, analysis results, and diagnostic history, while a power supply unit powers the device. A USB unit facilitates data transfer between the device and external devices, enhancing its clinical usability. 15
Figure 1
20 , Claims:WE CLAIM:
1. An automatic device (100) for detecting tear ferning patterns for the diagnosis of dry eye conditions, comprising:
a housing configured with a glass slab holder adapted to hold a glass 5 microscope slide containing a tear fluid sample;
an adjustable lighting module (102) configured to the housing to provide consistent illumination to the tear sample on the slide;
a microscope unit (103), including an automatic focusing module, configured to magnify the tear ferning patterns formed on the slide; 10
a high-resolution imaging unit (101) configured to the housing to capture images of the tear ferning patterns;
an image processor (104) configured to the housing to analyze the captured images of the tear ferning patterns, wherein the analysis includes pattern recognition and classification of the tear ferning patterns into 15 predefined grades;
a display unit (105) configured to housing to present the captured tear ferning images, the analysis results, and provide an interactive user interface for clinicians;
a data logging unit (112) for storing captured images, analysis 20 results, and diagnostic history;
a power supply unit configured to the housing to provide power to the housing; and
a USB unit configured to housing for data transfer between the device and external devices. 25
2. The device (100) as claimed in claim 1, wherein the glass slab holder is holding the glass microscope slide in a stable position during the drying and imaging process, to prevent movement or vibration.
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3. The device (100) as claimed in claim 1, wherein the adjustable lighting module (102) allows adjustments in brightness and angle to ensure optimal visibility of the tear ferning patterns under varying ambient lighting conditions.
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4. The device (100) as claimed in claim 1, wherein the microscope unit (103) is configured to provide automatic focusing to ensure sharp image clarity for detailed analysis of the tear ferning patterns.
5. The device (100) as claimed in claim 1, wherein the high-resolution imaging 10 unit (101) is adjustable focus settings to enable the capture of precise images of microstructural details in the tear ferning pattern.
6. The device (100) as claimed in claim 1, wherein the image processor (104) is configured to classify the tear ferning patterns into grades from 1 to 4 15 based on the density, branching, and gaps of the crystallized tear ferning structures.
7. The device (100) as claimed in claim 1, wherein the display unit (105) includes a zoom feature that allows a clinician to zoom in on specific areas 20 of the tear ferning pattern for closer inspection.
8. The device (100) as claimed in claim 1, further comprising a report generation module configured to generate a comprehensive diagnostic report that includes the captured image, the ferning pattern classification 25 grade, and recommendations for treatment or further testing.
9. A method (200) of diagnosing dry eye conditions, comprising:
collecting (201) a tear fluid sample from a patient's lower eyelid;
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placing (202) the tear fluid sample on a clean, sterile glass microscope slide and inserting the slide into the glass slab holder;
drying (203) the tear fluid sample under ambient conditions;
illuminating (204) the dried tear fluid sample using the adjustable lighting unit; 5
capturing (205) high-resolution images of the tear ferning patterns using the microscope unit and high-resolution imaging unit;
processing (206) the captured images using the image processor to analyze and classify the ferning patterns;
displaying (207) the captured images and the analysis results on the 10 display unit for review by the clinician;
generating (208) a comprehensive diagnostic report including the image of the ferning pattern, the classification grade, and additional notes or recommendations; and
transferring (209) the captured images and analysis results to using 15 USB unit for additional analysis or integration into electronic health records