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Portable digital medical camera for capturing images of the retina or the external auditory canal, and methods of use

Portable digital medical camera for capturing images of the retina or the external auditory canal, and methods of use description/claims

This application claims priority of Provisional application Ser. No. 60/700,513 filed on Jul. 19, 2005, the disclosure of which is incorporated herein by reference.

This invention was made with Government support under (Grant Number 2 R44 EY 13492-02) awarded by the National Bye Institute. The Government has certain rights in the invention. The inventor is an employee of the assignee, Optimum Technologies, Inc. of Southbridge, Mass.

This invention relates to a digital camera that is adapted to capture high-quality images of the retina and/or the external auditory canal of the ear, and transmit the images to an expert at a remote location, and to methods by which such a camera is used.

Diabetic Retinopathy is the leading cause of blindness of adults aged 20-74 years, causing up to 14,000 new cases of blindness each year. 15.7 million Americans, or 8.2% of the adult population, have diabetes, with approximately one-third of these cases undiagnosed. Nearly half of these people will develop some form of detectable diabetic eye disease in their lifetime. Ominously, the incidence of the more common Type 2 diabetes (formerly known as non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes) is predicted to rise sharply within the next decade, farther increasing the number of Americans at risk for vision loss and blindness. These facts show that diabetic retinopathy is a very serious and pervasive health risk among the American populace. Fortunately, blindness caused by diabetic retinopathy can be successfully prevented, if detected early enough. Strict monitoring and control of blood sugar levels has been shown to delay onset and slow progression of diabetic eye disease. For those who have already developed diabetic retinopathy, laser coagulation treatment has been shown to significantly reduce the risk of blindness. The odds of successful treatment are higher when treatment is administered in the early stages of the disease, further increasing the importance of early detection.

There is no disagreement on the need for regular screening of the diabetic population, but studies indicate that many people at risk still do not get adequate screening for ocular complications of diabetes. One study found that 26% of younger-onset diabetics and 36% of older-onset diabetics had not had an ophthalmic exam, and that 7% of younger-onset and 11% of older-onset diabetics had either never had an eye exam, or had not visited an ophthalmologist within the previous two years. The lack of proper screening is even more severe among the population groups that are at greater risk, such as African Americans or Latinos; groups who are nearly two times more likely than non-Hispanic whites to get diabetes. Characteristics of groups less likely to get the recommended ophthalmic care include low education, low income, shorter duration of diabetes, less severe diabetic retinopathy, no history of ocular problems, inadequate or no health insurance, and youth. Minorities, non-English speakers, those not seeing a diabetes specialist, and non-insulin users are also less likely to get the recommended eye exams. Potential barriers to screening include cost, lack of time, lack of transportation, no insurance coverage for the eye exam, lack of access to a local eye care provider, lack of a referral from the treating physician, lack of awareness about the importance of screening, and lack of understanding of potential risks and benefits.

Telemedicine is a method of providing medical care from a remote location electronically via telephone, Internet, satellite, or other electronic means. In a typical telemedicine application, a device known as a “telemedicine peripheral” is used to collect physiological data or images, which are transmitted to an expert at a remote site for analysis. The person who takes the data need not be highly skilled if the peripheral can be made simple enough to use. In some cases, the person using the telemedicine peripheral device may be the patient themselves, as evidenced by the growing market for home care telemedicine monitoring peripherals. Another popular application of telemedicine is a remote consultation facilitated by a videoconference between the patient and the medical caregiver.

Telemedicine has historically been touted as a solution to the problem of access to medical care. Telemedicine is a viable way of addressing the issues of remote location, lack of access to specialty providers, and managed care cost constraints. Telemedicine promises improved access to medical care to diverse groups of people ranging from astronauts and soldiers to rural families and inner city residents. The notion has been around for decades, but the enabling technology is relatively new. Growth has been rapid in the 1990s, but implementation is still low. Some of the barriers to widespread implementation include technical issues such as bandwidth and image compression, licensing issues, malpractice concerns, physician reluctance, confidentiality concerns, and reimbursement issues. The technological barriers are retreating quickly due to advances in the rapidly expanding field of telecommunications. Driven by increasing technological breakthroughs and the pressures of cost-containment, interest in resolving the legal, ethical and reimbursement issues telemedicine continues to build on both a national and local level. Several states have developed their own telemedicine pilot programs, and various branches of the federal government have made a significant investment in telemedicine research and development.

Patient acceptance of telemedicine has been reported under numerous studies to be consistently positive, with overall satisfaction as high as 98.3%. User satisfaction is also positive, eliminating another potential barrier to widespread use. Telemedicine is proving to be a cost-effective way to provide medical care, particularly when used for screening purposes. For example, the Navy determined in a recent study that installation of telemedicine systems on-board ships would be cost effective, saving unnecessary MEDEVACs costing several thousand dollars each. Overall, the outlook is positive for the future growth of telemedicine. Telemedicine has the potential to completely revolutionize the healthcare industry, restructuring nearly every aspect of twenty-first century medicine.

TeleOphthalmology seems particularly well suited to rapid screening for diabetic eye disease. Several studies indicate that non-mydriatic retinal imaging, including digital imaging, is a viable and effective way to screen for diabetic retinopathy. Problems with this method include false positives, which are rare, and poor image quality unsuitable for accurate diagnosis. These problems are not pervasive, and do not outweigh the advantages of this method of screening. The main cause of poor image quality is corneal opacity, which is a problem mainly for older patients. Such patients are far more likely to be under regular ophthalmic care, and are less likely to need this type of screening for this reason.

Currently, ophthalmology systems for telemedicine exist, but their usefulness has been restricted by their high cost, large size, and complexity of use. Even products touted as “hand held” include a tethered connection to a larger base unit (Nidek NM-100 is one such example). These products tend to be multi-functional and are intended for use by ophthalmologists, optometrists, or other highly skilled medical professionals. Their costs range from $12,500-$32,000 or more for complete instruments that are telemedicine-ready, to thousands of dollars for a simple video add-on that is useful only if the physician also possesses a compatible ophthalmoscope. Physicians in poor or rural areas are not likely to have the space, funds, or skills necessary to make use of these devices. These instruments are less likely to appeal to other primary care providers as well.

This invention features a simple, compact, low-cost screening device targeted toward medical practitioners with little or no prior experience with retinal imaging or imaging of the external auditory canal. The market for such devices is likely to grow in size as the shift toward lower-cost medical providers continues, driven by the managed care industry. An aging population, and rapidly growing incidence of diabetes also drive this market. Primary care physicians are called on more frequently to do the work of specialists, and nurse practitioners are taking on more of the duties of doctors, including seeing patients. Doctors will continue to surrender more of their traditional duties to less-skilled staff and will assume more of a care manager and advisory role for their patients. It is important for medical device developers to keep this trend in mind in order to place the proper emphasis on ease of use and simplicity of their devices, especially those intended for use by non-specialists. Since it is clear in the case of diabetic retinopathy screening that the best chance of maximizing the diagnosis of retinal disorders is through screening within the primary care setting, the invention provides for increased access to screening for the populations that need it the most. In rural and underserved areas where the lack of specialists coincides with the lowest rate of screening, highest risk of undetected diabetic eye disease, and the least amount of resources to buy large and expensive equipment, the small, low-cost inventive digital ophthalmoscope provides a promising means to decrease the incidence of blindness and vision loss among diabetics.

The inventive handheld, battery-powered device acquires images of the retina. The images can be transmitted from the examination site to an expert reading center via a standard telephone line, cellular link, or Internet connection. An expert consultant can then view the images on a high-resolution color monitor. The images may be compared to previous images stored for that particular patient, or to a library of standard diagnostic images. A diagnostic response may be made back to the referring party within minutes, either by telephone, fax, pager, or e-mail. If evidence of retinal abnormality is seen, the patient may be referred to an ophthalmologist for a complete mydriatic exam and follow-up treatment. For the primary care physician, routine screening of high-risk patients may be offered economically. The periodic monitoring of known diabetic patients will improve their standard of care and reduce medical costs by detecting ocular problems at an early, treatable stage. The device may also be used as part of a routine physical exam, and may be able to identify previously undiagnosed diabetics by means of diabetic retinopathy. Some patients already have detectable diabetic retinopathy by the time a diagnosis of diabetes is made. An eye exam included as part of a routine physical may also allow other eye diseases to be detected earlier and referred to an ophthalmologist, since patients with no perceived visual problems are not as likely to have regular eye exams.

In addition to the telemedicine service, image data can also be output from the inventive device in standard file formats for storage in any personal computer. Data formats can be compatible with emerging Picture Archiving and Communication Systems (PACS) standards such as the Digital Imaging and Communication in Medicine (DICOM) standard, enabling integration with the user's medical management software. Optional color printers may be used to produce hard copy records of the images for inclusion in paper records, to give to the patient, or to provide to another consulting practitioner. The ability to store images is important in order for a healthcare worker to quickly assess disease progression. There is a great opportunity for the advancement of scientific knowledge by having access to larger numbers of retinal images for research purposes.

• Provisional Patent
• Utility Patent

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