University of Houston (Houston, TX) Texas Instruments Incorporated (Dallas, TX)
1. Field of the Invention
This invention is connected to dermoscopy as well as biomedical screening equipment. The present invention relates to the creation of a medical device that is handheld that can be used for real-time skin cancer screening.
2. Description of the Related Art
The most common form of cancer, representing about half the number of all cancer forms. The most fatal kind of skin cancer is called melanoma which incidences rise by 33% per year. It is essential to check for suspicious skin pigmentation and other signs regularly. Skin cancer at its earliest stages has a high rate of cure, and it requires an easy treatment.
The American Cancer Society predicts that one out of six people will develop skin cancer and one out of nine will develop melanoma over their lives. The risk of melanoma is much higher in patients with dysplastic or clinically-abnormalpigmented nevi. A mole or nevus is a typical skin growth that is composed of melanocytes (special pigment-producing cells), which control the color of hair as well as the skin’s appearance. Dysplastic nevi are sometimes referred to as melanomas early, are skin lesions thatcarry an increased risk of developing melanoma.
Early detection of melanoma in patients with dysplastic nevi is vital. If detected at an earlier stage, skin cancer has one of the best cure rates and, in the majority of instances, the treatment is very simple and involves excision of the lesion.Moreover when detected at an earlier stage, skin cancers are very economical to treat, while at a later stage cancerous lesions often result in near fatal consequences and have extremely high costs for treatment.
When a malignancy is detected, early changes in the nevus are usually characterized by an uneven pattern of pigmentation before it can become fatal. The research shows that the diagnosis of visual signs by dermatologists is only 58% accurate. This is in contrast to 30% of non-specialists (doctor who do not specialize in early melanoma diagnosis). It is also known that diagnostic accuracy can be improved 80-93% by using imaging techniques like epiluminescence microscopy, to bettervisualize the pigmentation pattern, and by combining it with a clinically accepted quantitative scoring methods used by dermatologists for classification of lesions, such as the well-known A (asymmetry), B (border), C (color), and D (differentiation)rule and Menzies method, which is based on number of colors, symmetry of pattern, and the positive features of the lesion.
Imaging modalities currently in use depend on the pigmentation aspects of lesions, including its shape as well as its color and texture. Recent research has revealed a connection between angiogenesis and increased blood flow, which creates new blood vessels in response to a growing tumor’s high metabolic rate.
The devices currently used to study the skin’s surface can only capture images in one mode at an time. Furthermore, the images acquired are not readily processed. Though such devices find interesting uses, they present great limitations to users sincethe acquired images have to be transferred to personal computers to further analyze. The software currently available does not do image analysis, and it is not able to offer a clear diagnostic for doctors.
Thus, there is a need recognized in the art for a system which combines image acquisition with automated image analysis in medical devices for screening for skin cancer. Furthermore the prior art does not have portable handheld devices as well as software that can provide real-time skin cancer screening. This invention meets the long-standing desire and need in the field of science.
The present invention is directed towards a device that screens the individual’s skin in real time. The device includes means to program the device, controls to interact with users, methods to collect and display an image of the part of an individual’s skin, means to analyze and classify the image, as well as a method for controlling either or both data exchange with a personal computer and software receipt via a personal computer. The invention described herein is directed towards an additional device that includes devices to power the device. Another device similar to the present invention has means of housing it that can be both transported and carried in one hand.
The present invention is directed towards a device that screens the skin of an individual in real time. The device comprises a programmable digital signal microprocessor with a memory storing instructions executable by the processor and digitally linked to the other components of the device. The other components are a boot flash for parallel flash memory digitally connected to the microprocessor, an input device, a sensor having a combination of one or more light sources and one or more imaging sensors, adigital to analog signal video encoder connected to an off-board display terminal, an on-board display terminal, a wireless device configured to wirelessly communicate between the programmable digital signal microprocessor and a personal computer,including a parallel for a Universal Asynchronous Receiver/Transmitter, and a power management unit. A housing is also available in the gadget.
The present invention is further directed to a method of screening the skin of an individual in real-time. The method involves placing the handheld device in the area of interest that is prone to skin lesions. The invention also provides an equivalent method that wirelessly communicates the classification results to an individual computer.
The present invention is directed further still to a digital processor-implemented system for classifying a region of interest on the skin of an individual. The system is comprised of the module for pre-processing as well as image segmentation for the area of interest, a module for classifying an image of a lesions that occurs within the region of interest as a benign or malignant one as defined by one or more of a size variation and shape irregularity or formation each of which comprises apartial classification as well as a module that allows for decision-making based on the concept of confidence-based weighted averages of partial classifications and an image reconstruction module for three-dimensional image reconstruction of the area of the region of interest. A similar system is described in the present invention. It comprises an element that permits wireless communication between the processor (and personal computers) and a module for image reconstruction.
The present invention is further directed still to a processor readable medium that includes processor executable instructions to detect skin cancers of an individual in real-time. The method comprises of acquiringone or more images of a particular area on the skin, using one or more ways, preprocessing the acquired image(s) comprising extracting the lesion from the background and determining a border of the lesion using a region-fusion basedsegmentation with narrow band graph partitioning algorithms and classifying the skin lesions as malignant or benign using a confidence based weighted averaging of a mix of partial classifications based upon the characteristics of the skin lesions and displaying the results of classification.
The following description of the preferred versions of this invention, that is to be made public, will provide additional advantages and characteristics of the invention.Click here to view the patent on USPTO website.
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What is a software medical device?
The FDA refers to software functions that may comprise ” Software as a Medical Device” (SaMD) and “Software in Medical Device (SiMD) ), which is software that is integral to (embedded within) a medical device.
Section 201(h) of the Federal Food Cosmetic, Drug, and Act, ?21 U.S.C. 321(h),(1) defines medical devices as apparatus, device that are a machine, a contrivance, implant, in vitro-reagent, or other similar or related articles, including a component, or accessory which is. . . (b) intended for use in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of diseases in man or other animals, or (c) is designed to alter the structure or the function of the human body or any other animal.? Therefore, in order to be considered a medical device , and thus subject to FDA regulation, your program must meet one of two criteria:
- It must be intended to be used in diagnosing or treating an individual patient.
- It should not be designed to alter the structure or function of the body.
If the software you use is designed to be utilized by health professionals to diagnose, manage, or treat hospital patient records or other healthcare facilities, the FDA is likely to view such software to be medical devices and subject to regulatory review.
Is Your Software a Medical Device?
FDA’s current oversight, which focuses on the functions of the software over its platform is designed to ensure that FDA regulates to only devices that have functions that could pose danger to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is looking at include
- Software functions that aid those with mental disorders that are diagnosed (e.g. anxiety, depression and post-traumatic stress disorder (PTSD) for instance.) through the use of “Skill of the Day” or a behavioral strategy or audio message which the user can access when they are suffering from anxiety.
- Software functions that offer periodic reminders, motivational advice as well as educational information for patients who are recovering from addiction or trying to quit;
- Software functions that utilize GPS location data to warn asthmatics when they are near places of risk (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
- Software that makes use of games and videos to motivate people to do their exercise at home.
- Software functions that ask the user to input the herb or drug they wish to take in conjunction and offer information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
- Software functions that take into account the characteristics of the patient, like gender, age, and risk factors, to provide specific counseling, screening and preventive advice from established and well-respected authorities.
- Software functions that make use of a checklist to determine typical symptoms and give advice about when to see a doctor.
- Software functions guide a user through the questionnaire of signs and symptoms to provide an advice on the kind of health facility that is suitable for their needs.
- Mobile apps that are intended to let users make a pre-determined nurse call or emergency call using broadband or cellular phone technology.
- Apps that let patients or caregivers to communicate emergency alerts to first responders via mobile phones
- Software functions keep track of medication and offer user-configured reminders for improved drug adherence
- Software functions give patients access to their health information. This can include historical trending and comparisons of vital sign (e.g. body temperature, heart rate or blood pressure).
- Software functions that show trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rates)
- Software features let users either manually or electronically enter blood pressure data, to share it via e-mail or track it, and then trend it, and then upload it to an electronic health record.
- Mobile applications that give dental health reminders and tracking tools for users with gum disease;
- Apps that give mobile users access to information and tools for prediabetes patients;
- Apps that allow users to display messages and images on their mobile devices. These apps are a great option for addicts looking to quit addictive behaviors.
- Software functions that report drug-drug interactions and relevant information about safety (side effects and drug interactions, active ingredient) as a report , based on demographic data (age, gender) and medical information (current diagnosis) and the current medication and
- Software functions allow the surgeon to determine the best intraocular lens powers for the patient, as well as the direction of the implantation. The information is determined by the surgeon’s inputs (e.g. the expected astigmatism caused by surgery, the patient’s axial length, preoperative corneal astigmatism , etc.).
- Software, usually mobile apps transforms mobile platforms into a medical device that is regulated.
- Software that is connected to a mobile platform via the use of a lead or sensor to monitor and display electrical signals from the heart (electrocardiograph; ECG).
- Software that attaches sensors or other devices to the mobile platform in order to view, record and analyze eye movements to diagnose balance issues.
- Software that asks potential donors about their history as donors and their records, and/or sends those answers to an institution for blood collection. The software helps determine if a potential donor is eligible to collect blood or any other component.
- Software that connects to an existing device for control of the device’s operation, function or power source.
- Software that alters or deactivates the functions of an infusion pump.
- Software that regulates inflation or deflation of a blood pressure cuff
- Software to calibrate hearing aids and analyzes the sound characteristics and electroacoustic frequency of masters hearing aids and group hearing aids.
What does it mean if your software/SaaS is classified as a medical device?
SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.
So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.
Software As Medical Device Patenting Considerations
The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.
Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.
In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.
The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.
When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.
An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.
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