Breast cancer is pervasive. Early detection for breast cancer includes doing monthly breast self-exams and visiting a doctor to perform clinical breast exams and mammograms. However, monthly breast self-exams are performed by individuals that might not know what to look for or might not perform these exams regularly. Additionally, these users might not be able to visit the doctor physically due to the pandemic or other mobility concerns. Better early detection methods are needed.
The technology disclosed herein, in accordance with one or more various embodiments, is described in detail with reference to the following figures. The drawings are provided for purposes of illustration only and merely depict typical or example embodiments of the disclosed technology. These drawings are provided to facilitate the reader's understanding of the disclosed technology and shall not be considered limiting of the breadth, scope, or applicability thereof. It should be noted that for clarity and ease of illustration these drawings are not necessarily made to scale.
The figures are not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be understood that the invention can be practiced with modification and alteration, and that the disclosed technology be limited only by the claims and the equivalents thereof.
Embodiments of the application provide a breast cancer detection system by incorporating a medical device (e.g., formed as a sports bra), one or more user devices, and an analytics computing device. The medical device is incorporated with a plurality of sensors to detect changes in density (or other metrics) of the breast tissue. The medical device is placed snuggly over the breast tissue to generate measurements by the plurality of sensors. The measurements are transmitted to the analytics computing device to analyze over a time period. When the measurements exceed a threshold value, the analytics computing device may perform an action, including transmitting an electronic communication to a physician user or a patient user (e.g., to identify a potential issue, to transfer the measurement data, to recommend an action to the patient user). In some examples, the analytics computing device may be incorporated with a physician's office to update a patient's medical records or to notify the physician of the measurements.
Although breast tissue and a medical device (shaped like a sports bra) are illustrated and described throughout the disclosure, various types of tissue, body parts, and medical devices may be implemented. For example, any location where a lump (e.g., formed under the skin and pushed outward so that it is measurable at the surface of the skin, etc.) or change in tissue (e.g., soft, squishy, flexible to stiff, coarse, inflexible, etc.) may benefit from the medical device described herein. In either of these instances, the medical device may apply sensors to encompass the area of the body that may grow the lump or change in tissue.
Technical embodiments are realized throughout the disclosure. For example, standard systems do not incorporate a medical device operated by the user with a breast cancer detection system. The user must visit a physician's office to perform a clinical exam or mammogram. Even if the user has time to perform self-examinations, they are not trained to identify what differences in tissue measurements mean from month to month (or other time periods). With more frequent use, more measurement readings are obtained by the medical device described herein, thus allowing for more accurate readings and improving the data analytics overall. These analytics and results created were previously unattainable. Users are empowered to use the medical device with everyday life, which can detect changes in breast tissue more frequently and with more precision.
In another example, medical device 120 may transmit measurements to user device 130 via a first network 140 (e.g., near field communication (NFC), Bluetooth®, or other wired/wireless communication) and user device 130 may transmit measurements to analytics computing device 110 via a second network 140 (e.g., Internet). User 150 may operate medical device 120 by turning on medical device 120 (e.g., activating a battery embedded in medical device 120) or by putting on medical device 120 (e.g., to apply pressure to the sensors and initiate the process of generating measurements).
In another example, analytics computing device 110 may be embedded as a software application or cloud-based service at user device 130, such that analytics computing device 110 and user device 130 are a single device (as illustrated by the dashed line in
User device 130 may comprise a mobile device operated by user 150, including a smartphone, laptop computer, desktop computer, and the like. User device 130 may include customary device components of a mobile device, including an antenna, camera, battery, graphical user interface, memory, computer readable media, processor, and the like. User device 130 is configured to receive electronic communications from analytics computing device 110. User device 130 is also configured to provide the electronic communications at a graphical user interface to display information (e.g., for user 150).
User 150 may operate user device 130 to receive measurements from medical device 120 (e.g., via antennas at each medical device 120 and user device 130), transmit measurements to analytics computing device 110, or receive electronic communications from analytics computing device 110 regarding the modeling or measurements. Any of these transmissions may be initiated automatically, as described herein.
In some examples, user 150 may operate user device 130 to provide user information for a user profile and/or register to access analytics computing device 110 (either as an embedded software application at user device 130, as a standalone device accessible via network 140, or a cloud-implemented service, etc.). As part of the registration process, user may provide biographical and/or health information that may be stored in a user profile (discussed with
The user identifier may link to medical device 120 to user device 130 and user 150 as well. For example, when medical device 120 is powered on within a proximate distance to user device 130, the two devices may perform a handshake operation. Medical device 120 may transmit a beacon with identifying information (e.g., device identifier, number of sensors, location of sensor by sensor identifier, etc.) that is received by user device 130 (e.g., via a first network, NFC, Bluetooth®, etc.). User device 130 may receive the beacon and, in some examples, transmit a response to medical device 120. User device 130 may parse the beacon to determine the identifying information of medical device 120, and may transmit the identifying information to analytics computing device 110. Analytics computing device 110 may add the identifying information of medical device 120 to the user profile associated with user device 130 to correlate medical device 120, user device 130, and user 150 with the user profile.
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In each of these examples, fabric is provided to cover various sensors embedded within medical device 120. Fabric may be sewn to the structure of medical device 120 so that a first surface of the fabric communicatively connects with the skin of the user and an opposite surface of the fabric communicatively connects with one surface of the sensors. Various types of fabric may be used, including cotton, jersey, silk, satin, denim, velvet, thin and flexible polymer, or other fabrics that may help cover the sensors and the skin. Additional detail is provided with
Sensors 520 may comprise gauge-based pressure sensors, pressure transducer, pressure transmitter, pressure sender, pressure indicator, piezometer, manometer, or other similar sensor. Each sensor 520 may generate a measurement of pressure for an area surrounding the sensor, which may be based on the pressure produced between placing medical device 120 on the body of user 150 and measuring the resistance provided by the breast tissue.
In some examples, sensors 520 may measure density in the breast tissue. Each sensor may generate a measurement of density for an area around the sensor location of user 150 based on the density measurement produced by placing medical device 120 on the body and the detection of the density in the breast tissue generated by the sensor 520.
Sensors 520 may be adhered to fabric 510 to form a lattice or mesh of sensors to form the outline of medical device 120. In other examples, sensors 520 may be adhered to other sensors (e.g., first sensor 520A adhered to fabric 510A, second sensor 520B adhered to fabric 510A, etc.). Any adhesive is permissible. Fabric 510 with the lattice or mesh of sensors may form the outline of medical device 120.
The lattice or mesh of sensors 520 may be communicatively connected to each other, forming a plurality of connected sensors. In some examples, the angles between line segments connecting nearest neighbor points may approximately equal right angles, and the lengths of these line segments between nearest neighbor points may approximately be equal. As illustrated in
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In embodiments where first fabric layer 510A and/or second fabric layer 510B are implemented with medical device 120, either fabric layer 510A may be substantially tight to provide resistance against sensors 520 in the instance that a measurement value is received from the breast tissue. For example, the breast tissue may change over a time period to increase the density at a first location of a sensor from the plurality of sensors 520. Second fabric layer 520B may provide resistance so that, when the sensor physically pushes back in response to the increased pressure from the breast tissue and toward second fabric layer 520B, the fabric will provide resistance. The sensor may more accurately measure the pressure received from the breast tissue corresponding with the physical location of the sensor based on the resistance provided by the fabric.
In embodiments where first fabric layer 510A and/or second fabric layer 510B are removed, sensors 520 may form a lattice or mesh with each other, and while user 150 is wearing medical device 120, sensors 520 may be placed against the user's skin. Sensors 520 may be adhered to each other (e.g., directly adhered, adhered via conductive wires between the sensors, etc.) and the edges of the lattice or mesh of sensors 520 may form the outline of medical device 120. When pressure is applied to sensors from the user's skin, the resistance may be provided by surrounding sensors. Each of the sensor that is closest to the physical location of the breast tissue that provides the pressure data may also receive pressure data based on the lattice or mesh configuration of the sensors. In this case, the sensor and surrounding sensors may all measure the increased pressure received from the breast tissue corresponding with the physical location of the sensor. This may identify a wider area for a doctor checkup, but may still identify increased pressure over a time period at the particular location.
Sensor measurements may be transmitted along the line segments of the lattice or mesh of sensors 520 to processor 610, as illustrated in
Memory 620 may comprise random-access memory (RAM) or other dynamic memory to store information and instructions to be executed by processor 610. Memory 620 may be configured to store temporary variables or other intermediate information during execution of instructions to be executed by processor 610. Memory 620 may be connected to a bus for storing static information and instructions. Processor 610 may execute the computer-implemented instructions to receive the sensor measurements from sensors 520 and transmit them via antenna 640 to a second device (e.g., user device 130, etc.).
The sensor measurements may be transmitted in accordance with rules executed by processor 610. For example, the sensor measurements may be received as pressure is applied to a threshold number of sensors in the layer of sensors 520 (e.g., a baseline measurement, at least 70% of the sensors identifying some pressure which shows that the user is wearing medical device 120, etc.). Once the threshold number of sensors in the layer of sensors 520 detects a pressure measurement, processor 610 may determine the measurement (e.g., after a predetermined time period, like ten seconds, etc.) corresponding with each sensor and transmit the measurements and unique sensor identifier to user device 130 or analytics computing device 110 (or first to user device 130 via near field communication (NFC), and then transmit to analytics computing device 110 via network 140, etc.).
Battery 630 may comprise a standard battery or wearable battery, either of which may provide power to processor 610, memory 620, sensors 520, and antenna 640, or to charge one or more capacitors incorporated with medical device 120. In some examples, battery 630 may be charged via a power cable being plugged into the wall (while medical device 120 is not in use) and a converter, if needed. In some examples, graphene (e.g., two-dimensional carbon) and other related materials can be directly incorporated into medical device 120 to produce the charge.
Antenna 640 is also embedded with medical device 120. Antenna 640 may comprise a radio frequency (RF) front end design tuned for multiband or single band applications with single or multiple feeds. This may include a dual band GPS/Bluetooth® antenna (1 feed or 2 feeds), multiband 4G antenna using 1 feed or 2 feeds (1 for low band, 1 for high band), or 5G antenna. Antenna 640 may be channeled through the Industrial/Scientific/Medical (ISM) band. Antenna 640 may be communicatively coupled with user device 130 via a wireless network to transmit electronic communications between the two devices.
In any of these instances, medical device 120 may generate measurements of the breast tissue to form a baseline model of the breast tissue using the lattice or mesh of sensors 520 that cover the breast tissue. Sensors 520 may continue to generate measurements over time. The additional measurements may identify changes to the baseline model of breast tissue, creating a unique mapping of how the breast tissue (at the particular location) changes during various time periods (e.g., daily, monthly, etc.). Some of these changes over time may correspond with a monthly cycle of the user and are expected changes in the breast tissue. Some changes may be indications of breast cancer, as illustrated in
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Communication circuit 810 is configured to receive electronic communications from medical device 120 and/or user device 130. The communications may be transmitted by an antenna embedded in either device.
Communication circuit 810 is also configured to transmit electronic communications to user device 130. User device 130 may be operated by a patient user or physician user. In either example, the electronic communication may comprise a notification to seek additional medical care, capture an image of the breast tissue (e.g. using a camera embedded with user device 130, etc.), generate a model of the breast tissue (e.g., using medical device 120, as illustrated in
Modeling engine 820 is configured to generate a model of the breast tissue using a layout of sensors 520 incorporated with medical device 120. An illustrative model is provided with
Each sensor may correspond with an expected area of the breast tissue, for example, based on the shape and layout of sensors incorporated with medical device 120. As an illustrative example, sensors may be adhered or sown into medical device 120 at predetermined locations. These locations may include, for example, a first plurality of sensors mapped to the bottom of the medical device near an elastic band that fits around the user's upper waist to measure tissue changes in that area of the user, and a second plurality of sensors around the arm holes of the medical device to measure tissue changes around the user's armpit area. In some examples, sensors may be located to correspond with customarily fatty tissue of the user's breasts where changes in breast tissue traditionally occur, based on the layout of medical device 120 for fitting around breast tissue.
Machine learning circuit 830 is configured to receive inputs to a trained machine learning (ML) model and produce outputs that associate the inputs with a classification category and score. The inputs may correspond with the measurements generated by the sensors in medical device 120. The trained machine learning model may comprise weights and biases that align the inputs with one or more classification categories in a supervised machine learning model. The output of the ML model may associate the input with one or more classification categories. The classification categories may correspond with different types of breast cancer (e.g., potential issue, levels early/late, sizes of dense tissue large/small, etc.), normal changes in the breast tissue during a monthly cycle of the user, or other categories. The output may also comprise a score associating the sensor measurements with the score of the likelihood that the inputs correlate with each classification category.
The training of the ML model may include measurements generated by sensors of breast tissue where breast cancer is present and not present. The training may teach the ML model the rate of progression of the breast cancer and how the breast tissue changes over a time period, when the resulting state of the breast tissue includes the breast cancer or does not include the breast cancer.
Machine learning model 830 (with modeling engine 820) may generate output corresponding with each sensor of medical device 120. The output may identify a one or zero, for example, at the particular location of the sensor, although other output examples are available without diverting from the essence of the disclosure.
The “1” output may identify a likelihood over a threshold value that the particular area corresponding with the sensor comprises a hard or soft lump and the “0” output may identify a likelihood less than a threshold value that the particular area corresponding with the sensor comprises a hard or soft lump. The output may be generated for each sensor location as illustrated in
Notification engine 840 is configured to generate an electronic communication that includes information associated with the output of the ML model(s). The electronic communication may comprise, for example, the mapping of the one or zero to sensors 520 of medical device 120. In another example, the electronic communication may comprise potential areas of concern corresponding with a particular classification category and score. In yet another example, when the output includes a potential area of concern corresponding with a particular classification category and score, the electronic communication may aggregate any “1” results as an overall high likelihood result (e.g., greater than three or other threshold value, etc.). The aggregated result may correspond with an electronic communication to notify the user to visit a physician for additional clinical analysis (e.g., clinical exam, x-ray, magnetic resonance imaging (MM), surgical removal of the area and biopsy, etc.). The notification may also be transmitted directly to a user device of the physician to identify the patient's data (as permissible by law).
Analytics computing device 110 may also store various data, as illustrated with
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In some examples, the threshold values may be adjusted based on the user data in user data store 850. For example, if the user has a history of cancer, the threshold values in threshold data store 860 may be adjusted to increase the sensitivity in identifying changes in the breast tissue. In another example, if the user is less than a certain age (e.g., 40, etc.) with no history of cancer, the threshold values in threshold data store 860 may be adjusted to decrease the sensitivity in identifying changes in the breast tissue.
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Analytics computing device 110 may analyze data in the data stores to generate analytics in accordance with one or more rules. The rules may be received from a medical doctor or administrative user to help correlate the sensor values with issues that may indicate a potential for breast cancer. For example, when a measurement value from pressure data store 870 exceeds a monthly threshold value, the threshold flag may be activated (e.g., “1”). In another example, when a measurement value from pressure data store 870 fails to exceed a daily threshold value, the threshold flag may be deactivated (e.g., “0”).
In some examples, map 1200 may be automatically generated when the measurement exceeds the threshold value for a time period. For example, the measurement may exceed the threshold value for five days and not exceed the threshold on the sixth day. This may result in a mapping that does not overall exceed a threshold value and the mapping may identify a “0” indication. When the measurement exceeds the timing threshold value (e.g., twenty days, etc.), the mapping may indicate that the threshold value exceeds the measurement threshold value on the twenty-first day. These values may be altered by the physician user or patient user or in other embodiments automatically, without diverting from the scope of the disclosure.
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At block 1410, receive a measurement by a plurality of sensors at a breast tissue location. For example, analytics computing device 110 (or user device 130 when it is integrated with a software application providing components of analytics computing device 110, etc.) may receive a measurement by at least one of the plurality of sensors at a breast tissue location of a user. The measurement may be received from medical device 120.
Medical device 120 may comprise plurality of sensors and a processor. The plurality of sensors may be formed as a lattice or mesh to communicate sensor measurements to the processor of the medical device. Medical device 120 may or may not include fabric layers, as discussed herein.
At block 1420, compare the measurement with a threshold value. For example, analytics computing device 110 (or user device 130) may compare the measurement with a threshold value. The threshold value may correspond with increased pressure at the particular area over a time period. As an illustrative example, a sensor measurement for a first sensor during a first time period may be of 120 mmHg and the same sensor providing a second sensor measurement for a second time period may be 130 mmHg. The difference between these two measurements is 10 mmHg, which may be compared with the threshold value of 5 mmHg. The measurement value (or difference in measurements over a time period) may exceed the threshold value.
At block 1430, when the measurement exceeds the threshold value, generate an electronic communication. For example, analytics computing device 110 (or user device 130) may generate the electronic communication associated with the comparison. The electronic communication may identify “normal activity” or a suggestion to visit a doctor's office for additional consideration from a medical professional.
In some examples, a map is generated corresponding with the comparison and location of the sensors, as illustrated in
At block 1510, a measurement may be received by at least one of the plurality of sensors. The sensor may correspond with a breast tissue location of a user. For example, one or more sensors incorporated with medical device 120 may generate a sensor measurement and provide the sensor measurement along line segments connecting the sensors. The processor of medical device may receive the sensor measurement for processing, storage, and/or transmission.
At block 1520, the measurement may be transmitted to a computing device. For example, the processor of medical device 120 may receive the sensor measurements and generate an electronic communication that includes the sensor measurements. After a handshake procedure, medical device 120 may transmit the electronic communication to user device 130 or analytics computing device 110 for further analysis.
The further analysis may include, for example, comparing the measurement with a threshold value, and when the measurement exceeds the threshold value for time period, generate an electronic communication associated with the comparison.
In the foregoing description, numerous details are set forth to provide an understanding of the present invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these details. While the invention has been disclosed with respect to a limited number of embodiments, those skilled in the art will appreciate numerous modifications and variations therefrom. It is intended that the appended claims cover such modifications and variations as fall within the true spirit and scope of the invention.
This is a non-provisional patent application of U.S. Patent Application No. 63/084,002, filed Sep. 27, 2020, which is hereby incorporated by reference for all purposes.
Number | Date | Country | |
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63084002 | Sep 2020 | US |