Image analysis – Applications – Biomedical applications
Reexamination Certificate
2001-02-14
2004-09-14
Mehta, Bhavesh M (Department: 2625)
Image analysis
Applications
Biomedical applications
C600S306000, C377S010000, C356S404000, C250S201300
Reexamination Certificate
active
06792137
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to dermatology and more particularly to a method and device for aiding in screening populations of patients for skin cancer.
2. Background Information
Skin cancer, the most deadly form of which is melanoma, typically is diagnosed by a dermatologist examining pigmented skin lesions (colloquially known as “moles”) and/or other skin abnormalities on a patient. Typically, a dermatologist makes a determination based on visual inspection of each skin lesion's morphology, whether it is likely to be skin cancer or a potential precursor of skin cancer. This determination is made in the context of a patient's clinical history, risk factors for skin cancer, and other information. The dermatologist then decides if a pigmented lesion should the excised for histopathological evaluation.
Cutaneous melanoma starts growing in the top layer of the skin—the epidermis. If it is detected and completely removed while still confined to the epidermis, it can be completely cured, and has a very high cure rate if it has just entered the next skin layer, the papillary dermis. Thus screening and early detection are critical to lowering the morbidity and mortality of this cancer that has been increasing rapidly in incidence and is one of the most common cancers of young people, especially young women.
In 1992 a Consensus Conference sponsored by the National Institutes of Health recommended that skin cancer screening be initiated in the United States, but recognized that primary care physicians do not have sufficient training to perform it well.
If screening is attempted by those without sufficient experience, early melanomas may be missed and too many unnecessary biopsies may be performed.
SUMMARY OF THE INVENTION
It is an object of the present invention to improve access of potential patients to skin cancer screening experts using the Internet, thus enabling more efficient and cost-effective screening of large patient populations. It is a further object of this invention to empower consumers to assist in screening and monitoring their own skin and that of their family members, with guidance from skin cancer experts.
It is a further object of this invention to provide for consumers a digital epiluminescence microscopy (ELM) camera or a digital ELM lens attachment or lens stand that they may used with a digital or analog camera at home to obtain ELM photographs of pigmented lesions on their skin. ELM can improve the accuracy of screening and can help identify early, curable melanoma and benign lesions that mimic melanoma.
In the present invention, consumers may submit digital photographs of their pigmented lesions for clinical inspection by experts using digital cameras that they have at home. Alternatively, for a more accurate skin cancer risk assessment, they may submit photographs obtained with a special optical technique called epiluminescence microscopy (ELM). In this invention, two methods of performing ELM at home will be available to the consumer. In the first technique, the consumer will be instructed to wet their skin using water, alcohol, or oil. This will permit a crude type of ELM image by decreasing refractive-index mismatch at the air-skin interface, allowing visualization of some pigmented structures below the skin surface. The second technique requires a special ELM lens attachment that is also a subject of the present invention.
The present applicant has several patents issued or applications pending related to digital ELM and/or other aspects of monitoring the skin for skin cancer, particularly melanoma. For example U.S. Pat. No. 5,836,872 discloses a method and apparatus for in vivo monitoring of skin surfaces of the body to aid in the diagnosis of skin cancers. A digital ELM image, obtained under standardized conditions, enables in vivo visualization of pigmented or capillary features within the skin otherwise not visible to the eye. The device and method of the above-mentioned patent can aid a dermatologist or other skilled professional in diagnosing melanoma or other skin cancers. These features may be clues to early melanoma or to the presence of a melanoma mimicker that does not need surgery.
Early melanomas can be difficult to recognize since they may look similar to certain benign lesions. Moreover, many benign lesions may look like melanomas. Thus, screening is best performed by dermatologists or other physicians with expertise in skin cancer screening. If ELM-based screening is available the accuracy and cost-effectiveness may be improved further.
Dermatologists however, only see a small fraction of the potential number of patients that need to be screened. For example, in the United States there are only about 8000 dermatologists, but hundreds of thousands of primary care physicians. Thus many patients, in the U.S. and other countries, who need to be screened do not have access to a dermatologist and rely on primary care providers.
The Internet has recently become a leading source of medical information for consumers and holds promise for improving access of patients to both primary care providers and to specialists. Digital cameras are becoming widely available which provide the possibility for consumers to take digital photographs of their own skin lesions and transmit them to experts. Likewise, traditional analog photographs can be scanned so as to form digital images and sent to experts.
The present invention provides a method for providing a preliminary diagnosis of skin cancer, more specifically a screening risk assessment for individual pigmented skin lesion, comprising the steps of:
receiving digital photographs of skin abnormalities from a plurality of patients at a server;
receiving medical information related to the plurality of patients at the server;
assigning an identification to each of the plurality of patients;
reviewing the digital photographs and categorizing the skin abnormalities in the digital photographs into at least three categories so as to define category information, the at least three categories including a first category of a first risk, a second category of risk lower than the first category and a third category of insufficient photograph quality; and
providing the category information as a function of the identification.
The method of the present invention can permit a skilled physician to review the clinical and/or ELM digital photographs from a patient anywhere in the world, and quickly make a screening diagnosis or risk assessment for each photographed pigmented skin lesion.
Advantageously, the server may contain HTML-based pages of information, herein defined as the web pages. The web pages preferably are accessible to the public via the Internet, and contain information on the type of cameras preferable for digital photography with the method of the present invention, including, for example, information on proper photographic techniques for macrophotography of the skin, and ELM techniques such as placing oil, or other liquid, on the skin or using a special lens adapter with crossed polarizing filters. Users, preferably will submit clinical information related to their skin cancer history or risk factors by entering the information into predefined fields on the web pages.
However, the server may also contain HTML- or other computer language-based pages that reside on a server accessible through a private communications network, such as a LAN or WAN. This embodiment can increase the security of the present method.
Preferably, credit card or account information is received along with each photo. Standard e-commerce software may be included at the server to approve credit card submissions.
Information transmitted from and to the clients preferably is transmitted using a secure encryption technology, such as RSA encoding or other types of public key encryption methods. All web pages related to patient information preferably will use the best available security methods, such secure socket layer (SSL) technology or other as may be, or may becom
Azarian Seyed
Davidson Davidson & Kappel LLC
Mehta Bhavesh M
LandOfFree
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