Abstract:
The present invention is an ophthalmological diagnostic system adapted for use in urgent care facilities, physicians&#39; offices, hospitals, mobile treatment facilities, and in remote areas. The ophthalmological diagnostic system includes a component for securely holding a digital camera in optical communication with an ophthalmoscope and in various embodiments may include hardware and software for analysis and storage of images or video captured using the ophthalmological diagnostic system. The ophthalmological diagnostic system facilitates viewing of images and video by a single diagnostician or multiple diagnosticians.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part application that claims priority to U.S. Nonprovisional application Ser. No. 12/386,912 filed on Apr. 24, 2009 now U.S. Pat. No. 7,883,210, and herein incorporated by reference. 
    
    
     FIELD OF INVENTION 
     The present invention relates to the field of ophthalmology and more particularly to an ophthalmological diagnostic system. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1   a  illustrates a perspective view of an exemplary embodiment of an ophthalmological diagnostic system. 
         FIG. 1   b  illustrates a perspective view of a second exemplary embodiment of an ophthalmological diagnostic system with a memory card and viewing screen. 
         FIG. 1   c  illustrates a perspective view of an exemplary embodiment of an ophthalmological diagnostic system directly connected to a computer. 
         FIG. 2  illustrates an exemplary embodiment of a plurality of ophthalmological diagnostic systems with a diagnostician at a remote location. 
         FIGS. 3 and 4  illustrate exemplary embodiments of an ophthalmological diagnostic system with a plurality of diagnosticians at remote locations. 
         FIG. 5  illustrates an exemplary embodiment of a computer interface for an ophthalmological diagnostic system. 
         FIG. 6  illustrates an exemplary embodiment of a method of using an ophthalmologic diagnostic system. 
         FIG. 7  illustrates an exemplary embodiment of an ophthalmological diagnostic system kit. 
     
    
    
     GLOSSARY 
     As used herein, the term “in optical communication” means two or more devices perceiving the same image. For example, a digital camera in optical communication with an ophthalmoscope is capable of capturing the image as viewed by the ophthalmoscope. 
     As used herein, the term “optical communication housing” refers to a component that holds a device in optical communication with one or more devices. 
     As used herein, the term “image viewing means” refers to a device with an interface capable of displaying an image, video, or other digital representation. 
     As used herein, the term “camera activating means” refers to a component that signals a camera to capture an image or video. 
     As used herein, the term “storage component” refers to a hardware device capable of storing image data including, but not limited to a computer hard drive, database, memory card, flash drive, and an external hard drive. 
     As used herein, the term “grasping component” refers to a protuberance, contour, handle, or another part designed to be gripped by a hand to aid in the removal of one component from another. 
     As used herein, the term “diagnostician” refers to optometrists, ophthalmologists, and other individuals who are trained to analyze and identify conditions of the eye. 
     As used herein, the term “ophthalmological image recipient” refers to an individual who receives an image or video captured using an ophthalmological diagnostic system described herein for purposes of diagnosing or documenting an ophthalmological condition. Ophthalmological image recipients may include but are not limited to optometrists, ophthalmologists, physicians, physician assistants, medical personnel, medical and optometry students, technical and non-technical personnel, administrative personal, and any other individuals who may be involved in diagnosing or documenting an ophthalmological condition. 
     As used herein, the term “field of view” refers to the area or solid angle which can be viewed through an optical instrument, such as an ophthalmoscope. 
     As used herein, the term “filter” refers to a colored lens used to enhance a particular characteristic of an eye. 
     BACKGROUND 
     Ophthalmoscopes and slit lamps used to view the anterior segments and retina of an eye are known in the art. The WELCH ALLYN PANOPTIC ophthalmoscope is one example. The WELCH ALLYN PANOPTIC ophthalmoscope provides a panoramic view larger than standard ophthalmoscopes allowing the doctor to observe and identify conditions, such as hypertension, diabetic retinopathy, and papilledema. 
     When a disease or abnormality is observed, it is desirable to document the image that is visible in a photograph and/or video. Such documentation is important for diagnosis, as well as for comparison purposes and patient education. Ophthalmoscopes and slit lamps known in the art do not allow the doctor to capture the image, requiring that a second piece of equipment be used (e.g., a retinal camera). In an office setting, there are typically multiple machines that are used for photographing the eye. For example, there will be one machine designated for photographing the front of an eye and a second machine designated for photographing the back of an eye. When a patient is being seen in an out-of-office setting, such as a nursing home, it is impractical for the doctor to transport the bulky and expensive equipment required to both view and photograph the eye. 
     Camera equipment known in the art is undesirable for a number of reasons. The large size and bulkiness of existing optical cameras make them impractical to transport. In addition, these optical cameras lack the ability to photograph both the anterior and retina of a patient&#39;s eye, have a limited field of view, require a flash or a beam splitter to separate the optics, are clumsy to use, and/or take photographs of poor quality. 
     Ophthalmoscopes with digital documenting capabilities are known in the art. One is example is disclosed in U.S. Publication No. 2005/0110949 A1 (Goldfain et al.). Goldfain et al. teaches an eye viewing device with an imaging element that allows a practitioner to view an eye and sequentially image the same region of the eye for recording, documentation, and/or analysis. Another example is disclosed in U.S. Pat. No. 6,393,431 (Salvati et al.). Salvati et al. teaches an imaging instrument with a plurality of interchangeable instrument heads with an optical system capable of capturing and storing images and videos. 
     The devices taught by Goldfain et al. and Salvati et al. are not desirable because they are not capable of securing a digital camera to an existing ophthalmoscope without requiring alteration to the ophthalmoscope and allowing the digital camera to be subsequently removed from the ophthalmoscope so that it can be used without the digital camera. In addition, these devices are very costly. 
     GlobalMedia Group, LLC is one example of a company that provides telemedicine services and telemedicine hardware and software that allow healthcare providers to communicate with healthcare providers in other locations. One example of telemedicine hardware provided by GlobalMedia is the TOTALEXAM examination camera. The TOTALEXAM examination camera is a hand-held camera capable of capturing images in healthcare and non-healthcare settings. While the devices and services provided by GlobalMedia allow healthcare professionals to communicate with other healthcare professionals, the devices and services provided by GlobalMedia are not desirable for vision care. 
     It is desirable to have an apparatus capable of securely holding a digital camera and an ophthalmoscope in optical communication. 
     It is desirable to have an apparatus for holding a digital camera in optical communication with an ophthalmoscope allowing the anterior segment and retina of an eye to be photographed. 
     It is desirable to have an apparatus for holding a digital camera in optical communication with an ophthalmoscope that can be used with an existing ophthalmoscope without requiring alteration of the ophthalmoscope. 
     It is desirable to have an apparatus for holding a digital camera in optical communication with an ophthalmoscope that is compact, and makes efficient use of time and current technology. 
     It is desirable to have an ophthalmologic diagnostic system that is portable and specifically designed to be used in the field. 
     It is desirable to have an ophthalmologic diagnostic system that utilizes digital photography, video, and computer software for patient ocular care and quality medical records. 
     SUMMARY OF THE INVENTION 
     The present invention is an ophthalmological diagnostic system comprised of an optical communication housing for holding a digital camera in optical communication with an ophthalmoscope, a digital camera, an ophthalmoscope, and a computer. The optical communication housing houses a digital camera and fits securely over an ophthalmoscope, securely holding the digital camera in the proper position for digitally capturing the image visible through the ophthalmoscope. 
     The ophthalmological diagnostic system allows the user to communicate with diagnosticians for telemedicine purposes, and is specifically designed for use by anyone, including optometrists and ophthalmologists, in non-office settings, remote areas, anywhere traditional ophthalmological cameras are not available, or when communication with specialists for telemedicine purposes is desirable. 
     DETAILED DESCRIPTION OF INVENTION 
     For the purpose of promoting an understanding of the present invention, references are made in the text to exemplary embodiments of an ophthalmologic diagnostic system, only some of which are described herein. It should be understood that no limitations on the scope of the invention are intended by describing these exemplary embodiments. One of ordinary skill in the art will readily appreciate that alternate but functionally equivalent components, materials, designs, and equipment may be used. The inclusion of additional elements may be deemed readily apparent and obvious to one of ordinary skill in the art. Specific elements disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to employ the present invention. 
     It should be understood that the drawings are not necessarily to scale; instead, emphasis has been placed upon illustrating the principles of the invention. In addition, in the embodiments depicted herein, like reference numerals in the various drawings refer to identical or near identical structural elements. 
     Moreover, the terms “substantially” or “approximately” as used herein may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. 
       FIG. 1   a  illustrates a perspective view of an exemplary embodiment of ophthalmological diagnostic system  100  comprised of optical communication housing  10 , digital camera  30 , and ophthalmoscope  20 . Optical communication housing  10  houses digital camera  30  and is contoured to fit securely around ophthalmoscope  20 . 
     Optical communication housing  10  is secured to ophthalmoscope  20  by sliding optical communication housing  10  over ophthalmoscope  20  and snapping it down. When optical communication housing  10  is secured to ophthalmoscope  20 , digital camera  30  is positioned and held at the precise angle that places digital camera  30  in optical communication with ophthalmoscope  20 , providing an uninterrupted line of vision from digital camera  30  to the patient&#39;s eye. Visible in  FIG. 1   a  is interface  25 , the interface between ophthalmoscope  20  and digital camera  30 . 
     In the embodiment shown, ophthalmoscope  20  is a direct ophthalmoscope with a field of view of 25 degrees; however, in various other embodiments, ophthalmoscope  20  may be a direct or indirect ophthalmoscope, a scanning laser ophthalmoscope, or any other type of ophthalmoscope known in the art and may have a field of view ranging from 6.5 to 60 degrees. In various other embodiments, ophthalmoscope diagnostic system  100  may incorporate other technologies, such as optical coherence tomography (OCT), GDX nerve fiber analyzer (Laser Diagnostic Technologies, San Diego, Calif.), or any other technology known in the art for examining the eye. 
     In various embodiments, ophthalmoscope  20  may further include one or more filters or additional lens for enhancing or magnifying the image viewed by ophthalmoscope  20 . For example, ophthalmoscope  20  may include a red-free filter, a cobalt blue filter, a yellow filter, a slit aperture, a half-moon aperture, varying aperture sizes, a corneal viewing lens, and/or any other filter, lens, or component known in the art. In still other embodiments, the software may further include filters or other enhancement features, including but not limited to red-free filters, staining, overlays, magnification, pixel sampling, and measuring. In various embodiments, ophthalmological diagnostic system  100  may utilize software having analysis, enhancement, and/or image management capabilities known in the art, such as CAPSURE (GlobalMedia Group, LLC). 
     In the embodiment shown, optical communication housing  10  further includes snapshot button  15  for taking photographs or video depending on the setting selected. In the embodiment shown, snapshot button  15  is comprised of flexible pieces of optical communication housing  10  that are squeezed to take a photograph or video. In other embodiments, snapshot button  15  may protrude from optical communication housing  10 , be positioned outside of optical communication housing  10 , or be any other selection means that allows the user to take photographs or video. 
     In various other embodiments, digital camera  30  is not activated by pressing snapshot button  15 , but rather may be voice-activated or activated using a foot pedal, key stroke, mouse click, touch screen (e.g., if a viewing screen is used), or by any other means known in the art. 
     In the embodiment shown, optical communication housing  10  is angled to fit snugly around ophthalmoscope  20  and includes side plates  18 , which help to securely hold optical communication housing  10  on ophthalmoscope  20 . In the embodiment shown, side plates  18  are rounded; however, in other embodiments, side plates  18  may be square, rectangular, angled, or any other shape that helps hold optical communication housing  10  in place. 
     Optical communication housing  10  further includes grasping component  40  which aids in the removal of optical communication housing  10  from ophthalmoscope. In the embodiment shown, grasping component  40  is fin-shaped, protrudes from the top of optical communication housing  10 , and has a plurality of ridges that make grasping component  40  easier to grasp. 
     Also visible is USB cable  55 , which connects digital camera  30  to computer  50  (not shown). 
     In an exemplary embodiment, optical communication housing  10  is comprised of a weather and impact resistant vacuum forming ABS plastic, and is molded as two halves and integrated together. The lack of removable or interchangeable parts results in a device that is extremely durable. In other embodiments, optical communication housing  10  may be comprised of another type of plastic or other material, such as resin, aluminum or any other material capable of holding digital camera  30  in optical communication with ophthalmoscope  20 , and may be manufactured as a single piece or using another method known in the art, such as injection molding. 
       FIG. 1   b  illustrates a perspective view of a second exemplary embodiment of ophthalmological diagnostic system  100 . In the embodiment shown, optical communication housing  10  includes viewing screen  85 , which allows the user to view the same image as digital camera  30  and ophthalmoscope  20 , and memory card  95 , for storing acquired photographs and video. 
     In the embodiment shown, viewing screen  85  is secured to the edge of housing a hinge, allowing it to fold inward when not in use, while memory card  95  is inserted into a slot in the top of optical communication housing  10 . In other embodiments, viewing screen  85  and memory card  95  may be positioned elsewhere on optical communication housing  10 . For example, viewing screen  85  may protrude from the top of optical communication housing  10  or be located on the back of optical communication housing  10 , and memory card  95  may be inserted into a slot in the side of optical communication housing  10 . 
     In the embodiment shown, ophthalmological diagnostic system  100  does not require USB cable  55  for connecting digital camera  30  to computer  50  (not shown) as viewing screen  85  and memory card  95  may be used to view and store any acquired images and/or video. 
       FIG. 1   c  illustrates a perspective view of an exemplary embodiment of ophthalmological diagnostic system  100 . In the embodiment shown, digital camera  30  is connected to computer  50  via USB cable  55 . The image viewed by ophthalmoscope  20  is captured by digital camera  30  in the form of a photograph or video and displayed on the screen of computer  50 . To capture the image as a photograph or as a video, snapshot button  15  on optical communication housing  10  is pressed or digital camera  30  is activated by another means, such as by voice, foot pedal, key stroke, mouse click, or touch screen. 
     Ophthalmological diagnostic system  100  allows the image viewed through ophthalmoscope  20  to be captured. The images and/or video may be saved in the patient&#39;s file so that changes may be monitored over time, forwarded to a diagnostician for a consult, shown to a minor patient&#39;s parents, or used for patient education or another purpose. In various embodiments, ophthalmological diagnostic system  100  is ADA complaint. For example, ophthalmological diagnostic system  100  allows the ophthalmologist, optometrist, or other user to communicate with a deaf individual using the images/video captured using ophthalmological diagnostic system  100 . 
     In the embodiment shown, an ophthalmologist is using ophthalmological diagnostic system  100 ; however, the ability to capture images and/or video and forward them to an ophthalmologist for diagnosis makes ophthalmological diagnostic system  100  ideal for use by non-ophthalmologists and non-optometrists (e.g., emergency room doctors, military doctors). In addition, the portability of ophthalmological diagnostic system  100  makes it ideal for out-of-office visits and other settings where traditional ophthalmological camera equipment is not readily available, such as third-world countries, remote areas, combat zones, at sea, and in space. 
       FIG. 2  illustrates an exemplary embodiment of ophthalmological diagnostic systems  100   a ,  100   b ,  100   c  wirelessly connected to image database  90 . In the embodiment shown, ophthalmological diagnostic systems  100   a ,  100   b ,  100   c  are wirelessly connected to image database  90 , which stores images and videos acquired by the user of ophthalmological diagnostic systems  100   a ,  100   b ,  100   c . The images and videos may be wirelessly transmitted from image database  90  to computer  50   d  where they can be viewed and analyzed by a diagnostician, allowing a single diagnostician to be able to remotely view and analyze images and/or videos from multiple locations and users. 
     In an exemplary embodiment, images and videos are labeled and stored in image database  90  in a HIPAA compliant manner. For example, image database  90  will allow only authorized individuals to view the images and videos and will prevent the images and videos from being altered and resaved. In various embodiments, image database  90  may further compile statistical information for educational purposes. 
       FIG. 3  illustrates an exemplary embodiment of ophthalmological diagnostic system  100  connected to computer  50   a  via USB cable  55  and computer  50   a  is wirelessly connected to computers  50   b ,  50   c ,  50   d ,  50   e . In the embodiment shown, the user of ophthalmological diagnostic system  100  is a non-diagnostician. The images and/or video captured by the user are wirelessly transmitted to computers  50   b ,  50   c ,  50   d ,  50   e  where the images and/or video can be viewed and analyzed by a diagnostician and the condition diagnosed, facilitating collaboration among the user and one or more ophthalmologists. In an exemplary embodiment, one or more ophthalmologists can wirelessly transmit information back to computer  50   a  where it can be viewed by the user. 
     In other embodiments, the user of ophthalmological diagnostic system  100  may be an ophthalmologist, optometrist, or another individual trained to analyze and identify conditions of the eye. 
     In the embodiment shown, computer  50   a  is wirelessly connected to four computers and four diagnosticians; however, in other embodiments, computer  50   a  may be wirelessly connected to any number of computers and/or images/video may be received by any number of individuals. 
     In various embodiments, one or more of the diagnosticians viewing the images and/or video from a remote location may be able to control the software on computer  50   a  and/or ophthalmoscope  20  in order to obtain the views necessary for analysis and diagnosis. 
       FIG. 4  illustrates an exemplary embodiment of ophthalmological diagnostic system  100  wirelessly connected to computers  50   a ,  50   b ,  50   c ,  50   d ,  50   e . In various embodiments, ophthalmological diagnostic system  100  includes a wireless card, allowing information to be wirelessly transmitted to one or more devices. 
       FIG. 5  illustrates an exemplary embodiment of computer interface  70  for ophthalmological diagnostic system  100 . In the embodiment shown, interface  70  includes an image field, a plurality of text fields, and a drop down menu for selecting one or more symptoms. The text fields (e.g., anterior chamber angle, cornea diameter, lens length, cup-to-disc ration) allow the diagnostician to input one or more dimensions, which may be relevant to diagnosis. For example, cup-to-disc ratio compares the diameter of the cup portion of the optic disc with the total diameter of the optic disc, and is an important measurement for assessing the progression of glaucoma. 
     In an exemplary embodiment, computer interface  70  allows a user to view, save, and label images and videos, capture a still image from a video, as well as input diagnostic information and patient communication. In various embodiments, computer interface  70  may include a series of questions and/or user and may have additional functions, such as tracking individuals who have viewed the information, listing of potential treatment options, and/or providing a searchable image database for comparing the obtained images and/or videos with other images. 
     In another exemplary embodiment, computer interface  70  may have fields or be configured to allow a user to track, enter, or select signs and systems. The signs and symptoms may be correlated with a database which assists in diagnostics. For example, a corneal staining could be due a scratch or injury. But if other signs and symptoms (e.g., a rash on the nose, watering, burning, or tingling) are present, they could indicate that the appropriate diagnosis is not a scratch but rather a herpetic infection. Treating a patient for a scratch with steroids, rather than identifying herpes, causes hundreds of cases of blindness each year. (An estimated 400,000 individuals in the United States have had some form of ocular herpes. Each year, nearly 50,000 new and recurring cases are diagnosed in the United States.) Herpes simplex is the most common infectious cause of corneal blindness in the United States. 
     In another embodiment, software may be used to grade diabetic retinopathy. 
     In various embodiments, ophthalmological diagnostic system  100  utilizes advanced image analysis software with advanced graphical capabilities that allows the diagnostician to sample and test pixels to search for variants in the eye when a higher resolution image is not available and/or when visual inspection is not sufficient. 
       FIG. 6  illustrates an exemplary embodiment of method  200  for using an ophthalmologic diagnostic system. In step  1 , the user turns on ophthalmoscope  20  and in step  2 , the user adjusts the variable focus tumbler on ophthalmoscope  20  to focus on the desired portion of the eye. For example, to look at the back of the eye, the user will leave the tumbler at zero or move the tumbler downward; to focus on the front of the eye, the user will move the tumbler upward. 
     In step  3 , the user locks on a desired portion of the eye. The image viewed by ophthalmoscope  20  and digital camera  30  is displayed on computer  50 . In step  4 , the user presses snapshot button  15  on optical communication housing  10  to acquire the image or video, which may selected on computer interface  70 . 
     In step  5 , the user may sample the captured images/videos to calculate variances, the presence or absence of a condition, or any other measurement or observation desired. In steps  6  and  7 , the images/videos are authenticated and the user determines if the desired images/videos have been acquired. If not, additional images/videos are acquired. 
     In step  8 , if visual inspection is not sufficient, the diagnostician utilizes image analysis software to sample and test pixels or to enhance the image to search for variants, which may identify one or more conditions. In steps  9  and  10 , the patient&#39;s information is entered, and the images/videos labeled. 
     In other embodiments, the steps of method  200  vary and are dependent on the particular circumstances (e.g., the location, the patient&#39;s condition) as well as the training and education level of the user and diagnostician. 
     The images and videos captured using ophthalmological diagnostic system  100  provide the user or a remote diagnostician with a comprehensive visual image of the eye. The ability to capture a video, in addition to a still image, provides binocularity and motion parallax, allowing the diagnostician to determine the depth and elevation of various portions of the eye. In various embodiments, a plurality of still images may be combined to create a stereoscopic or three-dimensional image of the eye. 
     A comprehensive visual image of the eye can reveal innumerable ocular and systematic traumas and conditions of the eye lid (e.g., blepharitis, herpes zoster, herpes simplex, madarosis, poliosis, pediculosis, chalazions, hordeolums, contact dermatitis, ptosis, dermatochalasis, ectropion, entropion, trichiasis, bell&#39;s palsy, floppy eyelid syndrome, tumors, nevi, papillomas, cysts, hemangiomas, malignancies, neurofibromatosis, dacryocyctitis, and dacryostenosis); conjunctiva (e.g., foreign bodies, subconjunctival hemes, dry eye, chemosis, follicles, papilla, hyperemia/injection, phlyctenule, lymphatic cysts, conjunctivitis—viral, bacterial, or allergic (ocular like GPC or systemic like Chlamydia), episcleritis, scleritis (autoimmune issues, HLA-B27), and malignancies); cornea (e.g., abrasions, foreign bodies, ulcers, recurrent erosions, thermal burns, chemical burns, infections/keratitis (bacterial, fungal, parasitic, viral), dellen, SPK, edema, pannus, arcus senilis, keratopathy, degenerations, keratoconnus, Fuch&#39;s dystrophy, Wilson&#39;s Disease, and corneal neo); anterior chamber and iris (e.g., angle estimates, hyphema, cells/flare (anterior chamber reaction), KP&#39;s uveitis/iritis, cyclodialysis, colobomas, rubeosis (DM), anisocoria, Adies tonic pupil, Argyll Robertson pupil, Horner&#39;s syndrome, and iris nodules (NF); lens (e.g., cataracts, exfoliation, and lens dislocation); vitreous (e.g., floaters, posterior vitreal detachments, hemorrhages, asteroid hyalosis); macula and retina (e.g., hemorrhages, artery occlusions, vein occlusions, diabetic retinopathy, hypertensive retinopathy, macular degeneration (ARMD), vitreal maculopathies, central serous, macular edema, epiretinal membranes, myelination, drug maculopathies, retinal detachments, posterior uveitis, nevi, malignancies, CHRPEs peripheral degenerations, retinitis pigmentosa, albinism, benign retinal tumors, and congential malformations/colobomas); and optic nerve (e.g., optic neuritis (MS), glaucoma, and optic neuropathies). 
       FIG. 7  illustrates an exemplary embodiment of ophthalmological diagnostic system kit  300 . In the embodiment shown, ophthalmological diagnostic system kit  300  is comprised of case  310  and padding  320   a ,  320   b ,  320   c ,  320   d . To assemble kit  300 , padding  320   a  is placed inside case  310 . In the embodiment shown, padding  320   a  contains cavities for optical communication housing  10  secured to ophthalmoscope  20 , ophthalmoscope power supply  22 , USB cable  55 , and power cord  52  for computer  50 . When the components are positioned in the designated cavities, padding  320   b  is placed on top of the components. Padding  320   c  is then placed on top of padding  320   b  and computer  50  is placed inside the cavity in padding  320   c . Padding  320   d  is positioned on top. 
     In various other embodiments, diagnostic system kit  300  may contain any number of layers of padding and or be designed to fit in a larger, smaller, or differently sized case.