WO2014113681A1

WO2014113681A1 - Systems and methods for noninvasive health monitoring

Info

Publication number: WO2014113681A1
Application number: PCT/US2014/012061
Authority: WO
Inventors: Kenneth A. Wright
Original assignee: Eclipse Breast Health Technologies
Priority date: 2013-01-17
Filing date: 2014-01-17
Publication date: 2014-07-24
Also published as: EP2945529A4; EP2945529A1; JP2016508783A; CN105228507A

Abstract

Implementations described and claimed herein provide systems and methods for accessible and reliable routine health monitoring and noninvasive detection and early diagnosis of diseases and conditions. In one implementation, a health monitoring device is provided. The health monitoring device includes a light source configured to emit photons into an optical waveguide, which internally reflects the photons. A compliant surface is compressible against the optical waveguide during a scan of tissue. The compression of the compliant surface against the optical waveguide scatters at least one of the photons into the tissue and/or back through the optical waveguide. An imaging array is configured to collect the at least one scattered photon, forming an image representing a hardness of the tissue relative to surrounding tissue.

Description

SYSTEMS AND METHODS FOR NONINVASIVE HEALTH MONITORING

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001 ] The present application claims priority under 35 U.S.C. §1 19 to U.S. Provisional

Patent Application No. 61 /753,789, which was filed January 17, 2013 and entitled "AHST," and to 35 U.S.C. §1 19 to U.S. Provisional Patent Application No. 61 /753,785, which was filed January 17, 2013 and entitled "Breast Health Examination System." Each of the aforementioned applications is hereby incorporated by reference in its entirety into the present application.

TECHNICAL FIELD

[0002] Aspects of the present disclosure relate to routine health monitoring, among other functions, and more particularly to noninvasive detection and early indications or diagnosis of diseases and conditions, such as breast cancer.

BACKGROUND

[0003] For many human diseases and conditions, early diagnosis has a profound effect on survival rate. For example, breast cancer afflicts more than ten percent of American women, with hundreds of thousands of new cases diagnosed per year. Currently, approximately 61 percent of breast cancer incidences are successfully detected at an early stage, and of those cases, the survival rate is approximately 98 percent. Conversely, failure to efficiently diagnose breast cancer may result in the spread of the cancer into nearby tissues and/or distant regions of the body. In such cases, the five year survival rate is as low as approximately 27 percent.

[0004] Conventional methods for aiding early detection, even when performed correctly, generally carry a substantial risk of inaccuracy. For example, self-breast exams, while easy to conduct, are often performed by people who are unaware of the signs of a malignant tumor. As such, even a large lump may go undiagnosed for some time.

[0005] Mammograms are often utilized as a supplement to self-breast exams, providing a visualization of any malignancies. However, mammograms are generated using high-energy radiation, which can be dangerous, and in rare cases, lead to the development of cancer. Additionally, mammograms are highly prone to human error and/or inconclusive. Specifically, mammograms show only the shadow of a tumor and fail to reach important areas like lymphatic system near the upper arm/chest region. Thus, detection relies heavily on the interpretation of such shadows by a trained physician. Based on this reliance, physicians have overlooked up to 29 percent of tumors that would have been detected by their peers.

While nuclear magnetic resonance imaging (MRI) techniques may reveal intricate details of the size and shape of a tumor, the resolution is still too low to detect relatively smaller tumors, and such techniques are generally complicated, time- intensive, and expensive, further reducing effectiveness in aiding early detection. Exams utilizing conventional optical methods generally involve the injection of a fluorescent stain or other foreign compound, which often deters people from regularly obtaining such exams. Additionally, such optical techniques may be prone to interference from the size and shape of the patient's body and/or the fluorescence of surrounding tissue, thereby scrambling the processing of optical signals. Addressing the scrambling requires complex analysis, which may introduce errors, including the production of false positives. Other modern techniques, for example involving the systemic distribution of a chemical marker or the use of biomarkers, similarly require the patient to receive an injection. These techniques are often performed over two separate appointments: one to perform the injection; and one to perform a test after a certain period of time has elapsed since the injection.

The primary conduit for early detection of breast cancer and other types of cancer remains regular screening. However, despite an increase in screening, many people still fail to regularly perform or receive exams. Many people lack the knowledge, willpower, access, and/or resources to regularly obtain exams. The side effects and drawbacks of the procedures coupled with the reliability of the results further deter people from obtaining regular exams.

These challenges are exacerbated for patients with or susceptible to other types of cancer, such as lung and bladder cancer. Many of the techniques discussed above are not available to assist in early detection of such cancers.

It is with these observations in mind, among others, that various aspects of the present disclosure were conceived and developed. SUMMARY

[0010] Implementations described and claimed herein address the foregoing problems, among others, by providing accessible systems and methods for reliable early detection and diagnosis of diseases and conditions. In one implementation, a health monitoring device is provided. The health monitoring device includes a light source configured to emit photons into an optical waveguide, which internally reflects the photons. A compliant surface is compressible against the optical waveguide during a scan of tissue. The compression of the compliant surface against the optical waveguide scatters at least one of the photons into the tissue and/or back through the optical waveguide. An imaging array is configured to collect the at least one scattered photon, forming an image representing a hardness of the tissue relative to surrounding tissue.

[0011 ] Other implementations are also described and recited herein. Further, while multiple implementations are disclosed, still other implementations of the presently disclosed technology will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative implementations of the presently disclosed technology. As will be realized, the presently disclosed technology is capable of modifications in various aspects, all without departing from the spirit and scope of the presently disclosed technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 shows an example handheld health monitoring device.

[0013] Figures 2A-2C illustrate bottom perspective, side, and top views, respectively, of the handheld health monitoring device of Figure 1 .

[0014] Figure 3 shows a side view of the handheld health monitoring device of Figure 1 in a docking station.

[0015] Figure 4 displays an exploded view of the handheld health monitoring device of

Figure 1 .

[0016] Figure 5 illustrates a diagram of an example sensor of a health monitoring device.

[0017] Figure 6 shows a diagram of an example optical sensor of a health monitoring device. [0018] Figure 7 shows a diagram of an example static or dynamic tactile sensor of a health monitoring device.

[0019] Figures 8A and 8B illustrate top and side views, respectively, of example coupling material having a guiding pattern for a health monitoring device.

[0020] Figures 9A and 9B display top and side views, respectively, of an example clinical health monitoring device.

[0021 ] Figure 10 shows an example health monitoring device having a mirror interface.

[0022] Figure 1 1 is an example health monitoring system, including a health monitoring application running on a computer server, computing device, or other device coupled with a network, for routine health monitoring and noninvasive detection and early diagnosis of diseases and conditions.

[0023] Figure 12 illustrates example operations for noninvasive detection and early diagnosis of diseases and conditions; and

[0024] Figure 13 is an example of a computing system that may implement various systems and methods discussed herein.

DETAILED DESCRIPTION

[0025] Aspects of the present disclosure involve apparatuses, systems, and methods for accessible and reliable routine health monitoring and noninvasive detection and early indications or diagnosis of diseases and conditions. The apparatuses, systems, and methods facilitate the performance of an exam, such as a breast exam, in various environments, including a patient's home, a hospital, a doctor's office, a clinical setting, a mobile setting, a fitness center, an alternative medicine center, wellness center, retail outlet (e.g., a drugstore), spa, or the like. Further, apparatuses, systems, and methods compare results from current exams of patient tissue to previous results to determine any changes in the tissue using a baseline reading of the tissue. Identification of any changes generates a communication to prompt the patient or healthcare provider to seek additional medical advice, testing, and/or diagnostics regarding the patient tissue.

[0026] In one aspect, a health monitoring system involving one or more a health monitoring device is provided, including one or more sensors. The sensors may include, without limitation, an optical sensor, a static tactile sensor, a dynamic tactile sensor, a red- green-blue (RGB) sensor, a Near Infrared (NIR) sensor, a thermal imaging sensor, a passive sensor, a skin chemical sensor, a waste chemical sensor, a microphone, a depth sensor, a stereoscopic sensor, a scanned laser sensor, an ultrasound sensor, a multiple wave sensor, a force sensor, and the like.

[0027] The health monitoring system facilitates access to reliable early detection of human diseases and conditions, such as breast cancer, through direct detection and the monitoring of physical and/or chemical changes over time. Performance of exams are simple, affordable, understandable, and efficient. During an exam, health information for a patient is obtained through the collection and processing of data collected by the one or more sensors. The health information may be processed, for example, using: the health monitoring device; a computing device; a remote computer server or device at a centralized location, such as a doctor's office, medical laboratory, or the like; and/or using a secure cloud-based application running on a computer server and accessible using a user device. The health information may be used to identify the possible presence of a disease or condition and to monitor any changes. Diagnostic results and corresponding information are delivered to the patient in an understandable manner, reducing the reliance on human interpretation of data. As such, exams may be regularly performed and analyzed by a layperson, an assistant, and/or a trained professional.

[0028] In one particular aspect, the health monitoring device is a pressure point sensing device that may be used as an adjunct to traditional Breast Self-Examinations (BSE). The device locates and documents features found during a routine BSE by collecting digital image data for reference. During an exam, a user, such as the patient, scans the device over a breast in a systematic pattern. The device provides a digital pressure-based map of the scanned breast that may be stored, analyzed, or discussed with a health care provider. More specifically, in one implementation, the device includes a light source, an optical waveguide, and a compliant surface or other opaque material. The light source emits light into the optical waveguide, which internally reflects the light. During an exam, the pressure of the breast tissue against the compliant surface compresses the compliant surface against the optical waveguide. The harder the tissue (e.g., in the presence of a hard lump or lesion) the more the complaint surface compresses the optical waveguide. As the compliant surface is compressed, the light reflected in the optical waveguide is back-scattered to a sensor, such as a camera, producing an image capturing the relative hardness and softness of the scanned tissue. Therefore, relatively hard tissue, possibly indicative of a tumor, will appear in the image captured by the camera. Regular exams will reveal any physical changes of such hard tissue over time.

The various apparatuses, systems, and methods disclosed herein provide for accessible and reliable routine health monitoring and noninvasive detection and early diagnosis of diseases and conditions. The example implementations discussed herein reference the detection of cancer in humans, and more particularly breast cancer. However, it will be appreciated by those skilled in the art that the presently disclosed technology is applicable to other human and non-human diseases and conditions.

For a detailed description of an example handheld health monitoring device 100, reference is made to Figures 1 to 2C. As can be understood from Figure 1 , the device 100 is sized and shaped to comfortably fit in a hand 102 of a user. In one implementation, the device 100 includes a body 104 and a protruding portion 106 extending outwardly from the body 104.

The body 104 may have various surface features, angles, and/or contours to facilitate use and enhance comfort. For example, as shown in Figures 2A-2C, the body 104 may be shaped like a computer mouse having surface contours 108 matching the shape of the hand 102. The protruding portion 106 may be a variety of shapes, including, but not limited to, spherical, cubical, conical, elliptical, angular, contoured, convex, or the like. The protruding portion 106 may be adapted to move relative to the body 104 during an exam as the device is moved along the surface of the scanned tissue. For example, the protruding portion 106 may have a rounded shape that rotates during an exam.

In one implementation, the body 104 and/or the protruding portion 106 house one or more sensors. The sensors may include, without limitation, an optical sensor, a static tactile sensor, a dynamic tactile sensor, an RGB sensor, a NIR sensor, a thermal imaging sensor, a passive sensor, a skin chemical sensor, a waste chemical sensor, a microphone, a depth sensor, a stereoscopic sensor, a scanned laser sensor, an ultrasound sensor, a multiple wave sensor, a force sensor, and the like. For example, the body 104 may include a camera 1 12 or motion sensor disposed near the protruding portion 106 to detect tissue surface features, translation along the surface of the tissue, and the orientation of the device 100 relative to the tissue. [0033] As can be understood from Figures 2A-2C, to operate the device 100 during an exam, a surface 1 10 of the protruding portion 106 is pressed against the target tissue (e.g., breast tissue), and the device 100 is moved systematically over the target tissue, for example, along a guide pattern. In one implementation, the surface 1 10 comprises a material that maintains a soft or pleasant sensation against the skin, including, without limitation, one or more of latex, vinyl, polypropylene, silicone, or other plastics. The surface 100 may contain a surface lubricant or lotion to facilitate smooth motion against the skin. The body 104 may include one or more grips 1 16 comprising rubberized or frictional pads to aid in the retention of the device 100 in the hand 102.

[0034] In one implementation, to enhance the clarity of the exam results, the device 100 may be rocked or gyrated, by the user or automatically, during the scan of the target tissue. The surface 1 10 may have chamfered or rounded edges to facilitate such motion. As the device 100 is moved, the sensors collect data corresponding to the target tissue. The data collected by the sensors is processed and analyzed by the device 100 and/or one or more other components of a health monitoring system. As shown in Figures 2A-2C, in one implementation, the device 100 includes a USB port 1 14 for connecting to a user device via a USB cable. In another implementation, the device 100 transmits data for storage, processing, analysis, or the like over a other wired, wireless (e.g., Wi-Fi, Bluetooth, etc.), or network connection (e.g., Wi-Fi, CDMA, CDMA2000, WCDMA, LTE, etc.).

[0035] For a detailed description of a docking station 120, reference is made to Figure 3, which shows a side view of the device 100 resting in the docking station 120. In one implementation, the docking station 120 charges the device 100 through power drawn from a power supply, which may include, without limitation, an electrical outlet, a battery supply, parasitic power from a computer (e.g., via a USB connection), collected solar power, or the like. For example, as shown in Figure 3, the docking station 120 may include a cable 122 for connecting to an electrical outlet, Universal Serial Bus (USB) port, or other power source to draw power. In one implementation, the docking station 120 is configured to collect data from the device 100 and transmit the data via the cable 120 or wirelessly to a computing device and/or over a network.

[0036] Referring to Figure 4, an exploded view of the device 100 is shown. In one implementation, the body 104 of the device 100 includes a first cover 122 and a second cover 124. The first cover 122 includes male engaging members 126 to engage corresponding female members of the second cover 124 to enclose the body 104 to form an interior housing 128. In one implementation, the covers 122 and 124 may be removed to disassemble the device 100 to facilitate replacement, disposal, cleaning, and/or upgrade of the components of the device 100.

[0037] The interior housing 128 contains interior components of the device 100. In one implementation, the first cover 122 includes a protruding section 130 for positioning a belt 132. The protruding section 130 is disposed relative to a cushion support 134 of the belt 132. A cushion 136 is positioned between the cushion support and a sensor 140. In one implementation, the sensor 140 is a pressure sensor for use in conjunction with a corresponding image capture button on the first cover 122 to capture images based on the user's input. In this instance, the cushion 136 provides controlled pressure to the sensor 140 from the image capture button. In one implementation, the belt 132 further includes a light pipe 138 positioned relative to a light source 146, such as a light emitting diode (LED). The light source 146 may provide visual status indications to the user.

[0038] The device 100 includes one or more additional sensors 142, 144 to collect health data. The sensors 142, 144 may include one or more of an optical sensor, a static tactile sensor, a dynamic tactile sensor, a red-green-blue (RGB) sensor, a thermal imaging sensor, a passive sensor, a skin chemical sensor, a waste chemical sensor, a microphone, a depth sensor, a stereoscopic sensor, a scanned laser sensor, an ultrasound sensor, a multiple wave sensor, and the like.

[0039] Where the sensors 142, 144 are used as part of an optical sensor, the device 100 emits and collects light in the visible and/or near-infrared wavelengths. The device 100 transmits light, either continuously or with short pulses, into and through target tissue to image the structure of the tissue, including interior tissue well below the skin. Examples of information that may be obtained by an optical sensor in one or more wavelength bands includes, without limitation: transmission, reflectance, absorbance, elastic scattering, spectral modulation, fluorescence, auto-fluorescence, phosphorescence, modulation of polarization, Raman scattering, photon Doppler shifting, path speed (index) modulation or retardation, beam focusing or defocusing, Schlieren interferometry, and the like. The sensors 142, 144 may further include a trackball or optical sensor and/or a gyroscopic, magnetic, or other positioning sensor to collect and log the location and orientation of the device 100 relative to the tissue surface. The location and orientation information may be used to process and register (e.g., stitch together) the images collected using the sensors 142, 144, as described herein.

[0040] The sensors 142, 144 can be utilized as part of a static tactile sensor, which reads tactile information from the surface of the target tissue. Malignant tumors possess various physical properties that are measurably different from normal tissue, including, for example: decreased elasticity; increased hardness; changes in bulk or shear modulus or other stress-strain quantity; bulging or inflammation; electric properties, including capacitance and inductance, electric impedance, electric potential, or electro-mechanical properties; heat or thermal emission or conduction; plasticity; acoustic or ultrasonic properties; and pressure wave deflection or refraction. As described herein, based on such properties, the static tactile sensor captures images of regions including malignant tumors with a camera.

[0041 ] Similarly, where the sensors 142, 144 are used as part of a dynamic tactile sensor, the device 100 includes a sonic or ultrasonic transducer and receiver for imaging deep tissue. In one implementation, a signal is channeled into the tissue by a device that rests on the surface of the tissue, inducing vibrations in the tissue. The modulations of the signal may be captured by the sensors 142, 144. In this case, ultrasonic imaging, palpitating the tissue (by hand or with a probing device), and scanning the sensors 142, 144 over the surface of the tissue, returns a map of information about the elasticity of the tissue. Because lower elasticity is a strong indication of malignancy of tumors, any potentially malignant tumors present in the tissue may be flagged.

[0042] In one implementation, the sensors 142, 144 include a thermal imaging sensor, which records images in mid-wave infrared wavelengths. To increase the quality of the data captured by the thermal imaging sensor, a change in the temperature of the target tissue is induced, for example, through exercise or the application of a controlled cooling or heating device to the target tissue. The thermal imaging sensor tracks the propagation of heat across the surface of the tissue. Because the surface temperature of the tissue is affected by the propagation of heat from points inside the body, any tumors may accelerate or delay the propagation of heat to some points on the surface tissue. Tracking these points and comparing information from previous exams may provide an indication of the presence of a tumor. [0043] The sensors 142, 144 may include one or more passive sensors, which may provide additional information about a patient's overall health. For example, the passive sensors may be used to monitor heart rate, skin conditions, body mass index, blood oxygenation, body temperature, body chemical outgassing, and/or other bodily functions or conditions.

[0044] During the course of daily activity, the body emits chemicals through the skin, some of which may be particular biomarkers for cancer, especially volatile chemicals. The dynamics of volatiles inside the body and skin is relatively well understood, and saturation takes place typically on a timescale of hours. One biomarker that is a byproduct of malignant tumors is formaldehyde, which is difficult to detect because it decays and disperses under environmental conditions. Accordingly, the sensors 142, 144 may include a skin chemical sensor for detecting the presence of volatiles indicative of malignant tumors.

[0045] In one implementation, the skin chemical sensor is used in conjunction with a garment worn by a patient in different conditions, such as while asleep, bathing, exercising, or the like. The garment is made of or contains a substance which absorbs chemicals from the body during wearing. For example, the garment may include patches positioned near target tissue (e.g., the breasts); the patches including such a substance. The garment collects formaldehyde and quickly transforms it into a chemical with a longer lifetime fixed inside the material of the garment. The skin chemical sensor identifies the concentration of the fixed chemical, which provides an initial concentration of formaldehyde. The garment may be removed for remote analysis using a skin chemical sensor. A probable location of any malignant tumors may be identified by analyzing the portion of the garment containing higher concentrations of the fixed chemical.

[0046] In another implementation, the skin chemical sensor performs a gas chromatography/mass spectrometry (GC/MS). For example, the garment or portion of the garment is embedded in a vacuum system, possibly after being dissolved in a solvent solution to re-release the volatile chemicals into gaseous form. A sensitive chromatography system analyses the components of the gas to determine whether a malignant tumor may be present. Alternatively or additionally, the garment or portion of garment may be placed in front of dogs or other animals trained to recognize the signature scent of breast cancer tumors or other biomarker signatures. If the garment is identified the animals a threshold amount of times, the garment is flagged as potentially corresponding to a malignant tumor. The analysis may be performed in sections to identify the portion of the garment containing the strongest emitting area, which likely corresponds to the location of the tumor.

[0047] The sensors 142, 144 may be used in conjunction with one or more tools to operate as a waste chemical sensor. Bodily waste generally contains the same biomarkers as skin chemicals, described above. For example, positively identifiable biochemical signatures may be present in urine, blood, and breath. In one implementation, the device 100 may include a balloon into which the patient exhales. The balloon fixes certain chemicals onto its surface over a specific time period, such as several hours. The balloon may be processed by a waste chemical sensor for cancer signatures. It will be appreciated that the device 100 may include a variety of other sensors or components for detecting and analyzing various health functions and conditions.

[0048] In one implementation, the device 100 includes a Printed Circuit Board (PCB) having internal electronics, a wired connection port 152 (e.g., the USB port 1 14) and one or more lens mounts 150. One of the lens mounts 150 is positioned relative to a light pipe cup 154 having a light source assembly and a sensor head 156. The other lens mount 150 is positioned relative to a lens 158. In one implementation, the second cover 124 includes an opening 160 the protruding portion 106 relative to the sensor head 156 and a window 162 in the surface of the second cover 124 relative to the lens 158.

[0049] Figure 5 illustrates a diagram of an example sensor of a health monitoring device. In one implementation, the sensor includes: an imaging array 200, such as Charge- Coupled Device (CCD) camera or other array of optical sensors; a PCB 202; one or more light sources 204, such as LED's, diode lasers, an organic LED, or suitably collimated incandescent light source; an optical waveguide 206; a sensor head 208; a compliant surface 210; and a lens 212.

[0050] In one implementation, the compliant surface 210 is pressed against the surface of the target tissue. Light emitted from the light sources 204 is reflected internally in the optical waveguide 206. Due to the physical properties of tumors described above, when the compliant surface 210 is pressed, rolled, or otherwise moved over tissue containing a tumor, lump, or other tissue relatively harder than surrounding tissue, more pressure is exerted onto the compliant surface 210. The increased pressure against the compliant surface 210 compresses the compliant surface 210 against the optical waveguide 206, resulting in frustration of the internal reflection of the light in the optical waveguide 206. Due to natural contours, the amount of frustration is directly proportional to the applied pressure, including at points directly over hardened tissue. A portion of the light escapes from the optical waveguide 206 through the compliant surface 210 into the tissue. The escaped light is scattered directly back through the compliant surface 210 and the optical waveguide 206. The back-scattered light is directed through the lens 212 and captured by the imaging array 200. The captured image resembles a map, in which points receiving more scattered light are those at which the tissue is more tightly pressed against the compliant surface 210, in some cases indicating the presence of an anomaly.

[0051 ] The image map may be processed and analyzed to determine whether the shape, size, and other properties of the hardened tissue indicate it may be malignant cancer. Further, the image map may be compared to image maps obtained from previous exams to determine whether the hardened tissue has grown quickly, possibly indicating the presence of a malignant cancer. In one implementation, a coupling material (e.g., coupling material 500) comprising a material having ribbed, pocked, or otherwise textured features may be placed between the compliant surface 210 and the tissue. Such features or an etched, embedded, or screened on pattern on a surface of the compliant surface 210 may maximize sensitivity of the device in the range of relevant pressures, as well as to facilitate connection with the surface of the tissue with increased traction. Such features or patterns may be tracked optically or using other sensors to track a location and orientation of the device 100.

[0052] In one implementation, the device includes a force sensor and display for providing the user with a feedback loop that informs the user of the exerted pressure of the compliant surface 210 against the surface of the tissue in substantially real time, enabling the user to maintain a constant amount of total pressure. Further, the device may include a proximity sensor, permitting the light sources 204 to emit light only when the compliant surface 210 is in close range to tissue, thereby conserving electrical power when an exam is not underway.

[0053] Figure 6 shows a diagram of an example optical sensor of the device 100. In one implementation, scanning tissue 300 containing a tumor 302 using the device 100 arranged as an optical sensor includes the transmission of light from one or more light sources 304, 306 along an optical path and the collection of such light. [0054] The optical path includes emitted light 308 and 310 from the light sources 304 and 306 respectively into the tissue 300. The light is back-scattered inside the tissue 300 into the device 100, where scattered photons 312 are collected by an element 314. The element 314 directs the photons 312 to a mirror 316, which redirects the photons through collimating optics 318 into a imaging array 320 (e.g., a CCD chip) for collecting the photons as an image. The imaging array 320 exports the received data for processing in locally in the device 100 or remotely via a cable 322 or wirelessly.

[0055] Referring to Figure 7, a diagram of an example static tactile sensor of the device 100 is shown. As shown in Figure 7, the device 100 arranged as a static tactile sensor may be used to scan tissue 400 having a relative hard lump 402.

[0056] In one implementation, during a scan, the device 100 is pressed, rocked, rolled, or otherwise forcefully contacted to the surface of the tissue 400, as described herein. Figure 7 illustrates a path 404 of a primary photon during the scanning. A primary photon is a photon that is scattered only in the presence of the hard lump 402 under the surface of the tissue 400. More primary photons are scattered based on the hardness and size of the lump 402. All photons originate at a light source 406 and enter an optical waveguide 408. Within the optical waveguide 408, the photons travel in incoherent directions but are always totally internally reflected at each encounter with a surface of the optical waveguide 408. The photon illustrated in Figure 7 interacted with the surface of the optical waveguide 408 directly above the lump 402, thereby designating the photon a primary photon.

[0057] Due to the enhanced pressure at this point due to the lump 402, a complaint surface 410 is compressed against the optical waveguide 408. The compression provides that the surface of the optical waveguide 408 no longer internally reflects the primary photon due to the relative optical indices of the optical waveguide 408 and the compliant surface 410. As a result, the primary photon travels into the compliant surface 410 where the primary photon is scattered and propagates transversely back through the optical waveguide 408, through a lens 414, such as a Fresnel lens. In one implementation, the primary photon propagates through the lens 414 where it reflects off a mirror 414 and onto an imaging array 416. In another implementation, the primary photon is back-scattered into the device 100 onto the imaging array 416. [0058] The image formed by the captured primary photons may be transferred to a processor 418 or other computing device via a cable 420 or wirelessly. As the device 100 is tracked along the surface of the tissue 400, the image or sequence of images captured is tagged with location and orientation data collected by a sensor 422. The data may be transmitted remotely via a wireless antenna 424 for processing, reconstruction, and analysis. The device 100 may be powered via one or more power sources, such as a battery 426, a wireless charging coil 430, or the like and controlled with an on/off switch 428. It will be appreciated that the device 100 may include addition sensors or components depending on the nature of the scan of the tissue 400. For example, the device 100 may include an embedded RGB camera to capture surface images of the tissue 400 to obtain information regarding surface features, such as moles, dimpling, or other surface skin changes.

[0059] In another implementation, the optical waveguide 408 may be replaced with two semi-rigid plates with smooth surfaces and relatively high deformability. Visible, ultraviolet, infrared, or microwave radiation is incident on the plates and interferes with itself from the inner surfaces of each plate, such that the image array 416 images an interferogram showing the deformation of the intra-plate gap. In a location where the hard lump 402 is present, the plates will be sufficiently deformed that a noticeable change or discontinuation of the pattern fringes appears, which may be analyzed to produce a pressure map.

[0060] In still another implementation, a plurality of layers is used as a sensing transducer.

A first layer proximal to the tissue 400 emits light toward the imaging array 416. A second layer comprises a linear polarizer, and a third layer comprises an optically active material. The orientation of the layers is such that regions under high stress produce proportionally higher modulations of the polarization. A fourth layer distal to the tissue 400 comprises a polarization analyzer. The resultant image thus contains regions of higher or lower intensity and/or dispersion based on the magnitude of the stress induced by pressing the device 100 against the tissue 400. The resultant image may be analyzed to produce a pressure map.

[0061 ] Turning to Figures 8A and 8B, it will be appreciated that the quality of collected sensor data, such as image data, may be enhanced by placing a coupling material 500 between the device 100 and the target tissue. The coupling material 500 may be, for example, a garment 502 or a disposable or impressionable object. The coupling material 500 may provide stabilization to the target tissue during the exam, for example, with a stiff or firm fabric or a reinforced fabric structure.

[0062] As can be understood from Figures 8A and 8B, in one implementation, the coupling material 500 includes a guide pattern 504, which provides the user with a diagram of an appropriate scan routine to follow for a particular exam. The example guide pattern 504 shown in Figures 8A and 8B may be used during a breast exam. The guide pattern may be visible or may be hidden until prompted by the device 100. For example, at least a portion of the guide pattern 504 may be illuminated with specific radiation emitted from the device 100 during a scan or may become visible when pressure is exerted against the guide pattern 504 during the scan.

[0063] In one implementation, the garment 502 includes one or more sensors 506 for performing manual or fully automated scans of target tissue. The sensors 506 may include any of the sensors described herein.

[0064] The garment 502 may press the sensors 506 against the target tissue (e.g., the breasts). As the sensors 506 move relative to the target tissue, the sensors 506 collect data for analysis. A pillow or cushioning object may similarly perform exams using one or more sensors like the sensors 506. Figures 9A, 9B, and 10 illustrate additional devices similar to and including many of the same components as the device 100.

[0065] Turning to Figures 9A and 9B, an example clinical health monitoring device 600 is shown. In one implementation, the health monitoring device 600 utilizes automated components and/or robotics. The relatively larger size of the device 600 may produce higher resolution data, thereby increasing the quality of the exam results. In one implementation, the clinical device 600 includes a table 602 to receive a patient for an exam and an arm 604 extending across the table 602, such that a plane of the arm 604 is generally parallel with a plane of the table 602. The arm 604 includes one or more sensors 606. The sensors 606 may include any of the sensors described herein. The health monitoring device 600 may perform a non-touch automated image scan or a touch-down coupling contact or tactile scan.

[0066] In one implementation, the patient lies on the table 602 with the target tissue positioned under the arm 604. In another implementation, the patient lies on the table 602 in any orientation, and the arm 604 may be moved over the target tissue. During a scan, the target tissue is pressed against the arm 604, for example, by raising the table 602 to the arm 604 or by lowering the arm 604 against the target tissue. The scan is performed by moving and/or gyrating the device 600, for example, using an actuator. The scan may be automated and/or controlled by a user, such as a technician or doctor. In one implementation, the arm 604 includes one or more rollers to maintain a controlled pressure against the tissue during the exam, without causing discomfort to the patient.

[0067] Referring to Figure 10, an example health monitoring device 700 having a reflecting or digital mirror interface is shown. In one implementation, the mirror interface 702 is a stationary screen-like display 702 having one or more sensors 704. The device 700 may be used alone or in conjunction with other health monitoring devices, such as the handheld device 100. For example, the device 700 may display a guide pattern layered over a real-time image of the target tissue of the patient for the patient to follow during an exam with the handheld device 100.

[0068] The sensors 704 may include any of the sensors described herein. For example, the sensors 704 may include one or more passive sensors or thermal imaging sensors to monitor the patient's health, including, without limitation, body temperature, blood oxygenation, skin properties or lesions, internal tumors or lesions, heart rate, or other bodily functions and/or conditions. The device 700 records such information using the sensors 704 and may display the information to the patient in real time or other times on the display 702.

[0069] In one implementation, the display 702 includes a screen on the rear surface of a conventional reflecting mirror, such that the display 702 functions as a conventional mirror having a reflective surface when the screen is off. In another implementation, the device 700 is included as part of a larger apparatus containing mirrors, such as a medicine cabinet. In still another implementation, the device 700 is a separate module that may be attached to a surface of a mirror. The device 700 may be placed on a surface (e.g., counter) or mounted (e.g., similar to an articulating makeup mirror). In yet another implementation, the display 702 is a digital mirror having a liquid crystal display (LCD) screen, or the like, and a camera for capturing an image for display on the screen. The device 700 may include additional components for collecting data or providing benefits to the patient. For example, the device 700 may include or be connected to a weight scale and/or contain illuminating sidebars to aid in application of beauty, health monitoring, or wellness products. The device 700 may be configured to perform exams in a variety of manners. In one implementation, the device 700 may include a motion sensor for detecting the presence of a patient and automatically initiate an exam. In another implementation, the patient or other user may program the device 700 to perform exams at specified regular intervals or upon the receipt of a command by the user. In still another implementation, the device 700 may include communications 706, including messages, alerts, reminders, and instructions, displayed on the display 702 to prompt the patient to conduct an exam.

The device 700 may include one or more modules 708 for accessing a repository of the patient's health information, including without limitation: tactile, ultrasound, electro-optic, and other scans; visual or other representations of diagnostic results; tissue maps; written and verbal notes, recorded by the patient, healthcare provider, or other party; or the like. The modules 708 may be used to display the health information to the patient on the display 702. Further, the device 700 may include one or more modules 710 for performing additional functions. For example, the modules 710 may be used to: send collected sensor data, pictures, video, or other health information to a healthcare provider over a network; communicate live with a healthcare provider over the network; delay the display of images of the patient to enable the viewing of body regions that the patient cannot see with a conventional mirror; or the like.

Figure 1 1 is an example health monitoring system 800 for routine health monitoring and noninvasive detection and early diagnosis of diseases and conditions is shown. In the implementation, a user, such as a patient, healthcare provider, or other interested party, accesses and interacts with a health monitoring application 802 via a network 804 (e.g., the Internet).

The network 804 is used by one or more computing or data storage devices (e.g., one or more databases 810) for implementing the health monitoring system 800. The user may access and interact with the health monitoring application 802 using a user device 806 communicatively connected to the network 804. The user device 806 is generally any form of computing device capable of interacting with the network 804, such as a personal computer, terminal, portable computer, mobile device, a tablet, a multimedia console, etc. [0074] A server 808 hosts the system 800. The server 806 may also host a website or an application, such as the health monitoring application 802, that users visit to access the system 800. The server 806 may be one single server, a plurality of servers with each such server being a physical server or a virtual machine, or a collection of both physical servers and virtual machines. In another implementation, a cloud hosts one or more components of the system 800. One or more health monitoring devices 812, the user devices 806, the server 806, and other resources, such as the database 810, connected to the network 804 may access one or more other servers for access to one or more websites, applications, web services interfaces, etc. that are used for routine health monitoring and noninvasive detection and early diagnosis of diseases and conditions. The server 806 may also host a search engine that the system 800 uses for accessing and modifying information used for health monitoring and noninvasive detection and early diagnosis of diseases and conditions.

[0075] In another implementation, the user device 806 locally runs the health monitoring application 804, and the monitoring devices 812 connect to the user device 806 using a wired (e.g., USB connection) or wireless (e.g., Bluetooth) connection.

[0076] Using the health monitoring application 802, a user may upload health information, including history and information corresponding to any prior exams. The health monitoring application 802 may generate reminders to prompt a patient to obtain an exam at regular or random intervals, dictate real-time instructions for the use of the monitoring device 812, and/or other tasks. The health monitoring application 802 may record a user's verbal or written notations during an exam using sensors in the monitoring device 812 and/or the user device 806.

[0077] In one implementation, the health monitoring application 802 includes various instructions for processing health information based on the type of data provided by the monitoring device 812. Stated differently, the health monitoring application 802 may process health information based on the type of sensor utilized by the monitoring device 812 during an exam.

[0078] For example, the monitoring device 812 may be used to collect a sequence of images at a reasonably fast rate (e.g., approximately ten frames per second) while simultaneously tracking the relative location and orientation of each subsequent image. The monitoring device 812 tags the images with such metadata, enabling the health monitoring application 802 to determine the overlap between any two images in the acquired image sequence. In one implementation, the health monitoring application 802 pre-filters the individual images to enhance properties of the images, such as contrast and overall intensity.

[0079] The health monitoring application 802 stiches the images together to form a map or composite image of the examined tissue, such as a breast. To create an accurate composite image, the health monitoring application 802 may perform functions, including, without limitation, intensity averaging, stretching or other diffeomorphisms (particularly to accommodate variations in perspective), phase correlation, application of a nonlinear color space, frequency-domain processing, feature identification, conversions to different coordinate systems (e.g., log-polar coordinates), and other manipulations. The health monitoring application 802 may process the composite image using algorithms, such as Monte Carlo or other simulation techniques, to translate the composite image into one or more different formats, such as an accurate visual representation of the scanned tissue. A visually realistic representation may incorporate not only restructuring of the intensity pattern, but also the elimination of visually detracting artifacts, such as Mach bands or haloing.

[0080] Once the health monitoring application 802 processes and analyzes health information corresponding to an exam of target tissue, the user may utilize the health monitoring application 802 to perform various functions. For example, the health monitoring application 804 may perform image feature identification to flag potentially problematic areas in the examined tissue that may need follow-up testing. The health monitoring application 804 may perform such functions automatically or upon a command from a user. Further, the health monitoring application 804 may compare a new image to images collected during other scans, taken at various times and/or with various sensors or other equipment (e.g., x-ray machine) to determine whether any significant changes occurred. In one implementation, the health monitoring application 804 performs image manipulation, registration, and/or differencing to align the images for comparison. Based on the comparison or direct analysis, the health monitoring application 804 generates a diagnostic result.

[0081 ] In one implementation, a user, such as the patient, downloads the diagnostic result to the user device 806, which the patient may bring to discuss with a healthcare provider. In another implementation, the health monitoring application 804 automatically or upon a command from the user submits a prompt to seek for review by a medical professional that may lead to diagnosis or the diagnostic result to the patient's healthcare provider over the network 802. The diagnostic result may include an identification of any watch spots, problem spots, recommendations for follow-up exams, such as a mammogram, and/or other analysis. The scans, diagnostic results, exam results, and/or any other health information may be stored in the database 810, which may be accessed by a user with the health monitoring application 804.

[0082] Figure 12 illustrates example operations 900 for noninvasive detection and early diagnosis of diseases and conditions. In one implementation, a receiving operation 902 receives an image or an image sequence and corresponding location data captured by a sensor during a scan of tissue by a monitoring device. Each of the images received during the receiving operation 902 is created by pressing the monitoring device against a surface of the tissue and corresponds to the pressure of the underlying tissue. As such, if a lump, lesion, or other hard abnormality is present in the tissue, the corresponding image received during the receiving operation 902 includes an element that is represented as harder than surrounding tissue. The image sequence and corresponding location data receiving during the receiving operation 902 may be pre-filtered prior to processing.

[0083] A registering operation 904 registers or stiches the image sequence together based on the location data to form a map of the tissue. The individual images or map of the tissue may be transmitted for storage and/or subsequent review by a user, such as a patient or healthcare provider. In one implementation, the registering operation 904 uses processing algorithms and/or image data mining algorithms, such as Monte Carlo or other simulations.

[0084] A generating operation 906 generates a diagnostic result based on the registered image sequence. The diagnostic result may include a determination of the presence or absence of any abnormalities. In one implementation, the generating operation 906 generates the diagnostic result using direct detection. In another implementation, the generating operation 906 generates the diagnostic result using image alignment algorithms that compare the registered image sequence to images from prior exams to identify any deltas representing changes of the target tissue. In still another implementation, the generating operation 906 generates the diagnostic result using image reconstruction and filtering. [0085] An outputting operation 908 outputs the diagnostic result. In one implementation, the outputting operation 908 transmits the diagnostic result to a user, such as the patient, a healthcare provider, or the like for review. In another implementation, the outputting operation uploads the diagnostic result for storage in an online repository or other database.

[0086] Figure 13 is an example computing system 1000 that may implement various systems and methods discussed herein. A general purpose computer system 1000 is capable of executing a computer program product to execute a computer process. Data and program files may be input to the computer system 1000, which reads the files and executes the programs therein. Some of the elements of a general purpose computer system 1000 are shown in FIG. 13 wherein a processor 1002 is shown having an input/output (I/O) section 1004, a Central Processing Unit (CPU) 1006, and a memory section 1008. There may be one or more processors 1002, such that the processor 1002 of the computer system 1000 comprises a single central- processing unit 1006, or a plurality of processing units, commonly referred to as a parallel processing environment. The computer system 1000 may be a conventional computer, a distributed computer, or any other type of computer, such as one or more external computers made available via a cloud computing architecture. The presently described technology is optionally implemented in software devices loaded in memory 1008, stored on a configured DVD/CD-ROM 1010 or storage unit 1012, and/or communicated via a wired or wireless network link 1014, thereby transforming the computer system 1000 in FIG. 13 to a special purpose machine for implementing the described operations.

[0087] The I/O section 1004 is connected to one or more user-interface devices (e.g., a keyboard 1016 and a display unit 1018), a disc storage unit 1012, and a disc drive unit 1020. Generally, the disc drive unit 1020 is a DVD/CD-ROM drive unit capable of reading the DVD/CD-ROM medium 1010, which typically contains programs and data 1022. Computer program products containing mechanisms to effectuate the systems and methods in accordance with the presently described technology may reside in the memory section 1004, on a disc storage unit 1012, on the DVD/CD- ROM medium 1010 of the computer system 1000, or on external storage devices made available via a cloud computing architecture with such computer program products, including one or more database management products, web server products, application server products, and/or other additional software components. Alternatively, a disc drive unit 1020 may be replaced or supplemented by a floppy drive unit, a tape drive unit, or other storage medium drive unit. The network adapter 1024 is capable of connecting the computer system 1000 to a network via the network link 1014, through which the computer system can receive instructions and data. Examples of such systems include personal computers, Intel or PowerPC- based computing systems, AMD-based computing systems and other systems running a Windows-based, a UNIX-based, or other operating system. It should be understood that computing systems may also embody devices such as Personal Digital Assistants (PDAs), mobile phones, tablets or slates, multimedia consoles, gaming consoles, set top boxes, etc.

[0088] When used in a LAN-networking environment, the computer system 1000 is connected (by wired connection or wirelessly) to a local network through the network interface or adapter 1024, which is one type of communications device. When used in a WAN-networking environment, the computer system 1000 typically includes a modem, a network adapter, or any other type of communications device for establishing communications over the wide area network. In a networked environment, program modules depicted relative to the computer system 1000 or portions thereof, may be stored in a remote memory storage device. It is appreciated that the network connections shown are examples of communications devices for and other means of establishing a communications link between the computers may be used.

[0089] In an example implementation, health information, data captured by the one or more sensors, information collected by the monitoring devices, the health monitoring application 804, a plurality of internal and external databases (e.g., the database 810), source databases, and/or data cache on cloud servers are stored as the memory 1008 or other storage systems, such as the disk storage unit 1012 or the DVD/CD-ROM medium 1010, and/or other external storage devices made available and accessible via a cloud computing architecture. Health monitoring software and other modules and services may be embodied by instructions stored on such storage systems and executed by the processor 1002.

[0090] Some or all of the operations described herein may be performed by the processor 1002. Further, local computing systems, remote data sources and/or services, and other associated logic represent firmware, hardware, and/or software configured to control operations of the health monitoring system 800. Such services may be implemented using a general purpose computer and specialized software (such as a server executing service software), a special purpose computing system and specialized software (such as a mobile device or network appliance executing service software), or other computing configurations. In addition, one or more functionalities of the health monitoring system 800 disclosed herein may be generated by the processor 1002 and a user may interact with a Graphical User Interface (GUI) (e.g., the display 702 of the device 700) using one or more user- interface devices (e.g., the keyboard 1016, the display unit 1018, and the user devices 1004) with some of the data in use directly coming from online sources and data stores. The system set forth in Figure 13 is but one possible example of a computer system that may employ or be configured in accordance with aspects of the present disclosure.

[0091 ] In the present disclosure, the methods disclosed may be implemented as sets of instructions or software readable by a device. Further, it is understood that the specific order or hierarchy of steps in the methods disclosed are instances of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the method can be rearranged while remaining within the disclosed subject matter. The accompanying method claims present elements of the various steps in a sample order, and are not necessarily meant to be limited to the specific order or hierarchy presented.

[0092] The described disclosure may be provided as a computer program product, or software, that may include a machine-readable medium having stored thereon instructions, which may be used to program a computer system (or other electronic devices) to perform a process according to the present disclosure. A machine- readable medium includes any mechanism for storing information in a form (e.g., software, processing application) readable by a machine (e.g., a computer). The machine-readable medium may include, but is not limited to, magnetic storage medium (e.g., floppy diskette), optical storage medium (e.g., CD-ROM); magneto- optical storage medium, read only memory (ROM); random access memory (RAM); erasable programmable memory (e.g., EPROM and EEPROM); flash memory; or other types of medium suitable for storing electronic instructions. The description above includes example systems, methods, techniques, instruction sequences, and/or computer program products that embody techniques of the present disclosure. However, it is understood that the described disclosure may be practiced without these specific details.

It is believed that the present disclosure and many of its attendant advantages will be understood by the foregoing description, and it will be apparent that various changes may be made in the form, construction and arrangement of the components without departing from the disclosed subject matter or without sacrificing all of its material advantages. The form described is merely explanatory, and it is the intention of the following claims to encompass and include such changes.

While the present disclosure has been described with reference to various embodiments, it will be understood that these embodiments are illustrative and that the scope of the disclosure is not limited to them. Many variations, modifications, additions, and improvements are possible. More generally, embodiments in accordance with the present disclosure have been described in the context of particular implementations. Functionality may be separated or combined in blocks differently in various embodiments of the disclosure or described with different terminology. These and other variations, modifications, additions, and improvements may fall within the scope of the disclosure as defined in the claims that follow.

Claims

CLAIMS WHAT IS CLAIMED IS:

1 . A health monitoring device comprising:

a light source configured to emit photons into an optical waveguide, the photons internally reflected in the optical waveguide;

a compliant surface compressible against the optical waveguide during a scan of tissue, compression of the compliant surface against the optical waveguide scattering at least one of the photons back through the optical waveguide; and

an imaging array configured to collect the at least one scattered photon, forming an image representing a hardness of the tissue relative to surrounding tissue.

2. The health monitoring device of claim 1 , wherein the tissue is breast tissue.

3. The health monitoring device of claim 1 , further comprising:

a body having one or more contoured surfaces.

4. The health monitoring device of claim 3, wherein the body is sized to fit within a hand of a user and the one or more contoured surfaces mirror the shape of the hand.

5. The health monitoring device of claim 1 , wherein the imaging array is a Charge-Coupled Device camera.

6. The health monitoring device of claim 1 , wherein the compression of the compliant surface against the optical waveguide increases proportionally to the hardness of the tissue.

7. The health monitoring device of claim 1 , wherein the compliant surface is pressed against a coupling material during the scan of the tissue.

8. The health monitoring device of claim 7, wherein the coupling material includes a guide pattern to guide the compliant surface during the scan of the tissue.

9. The health monitoring device of claim 1 , wherein the diagnostic result includes a prompt to seek review by a medical professional for diagnosis.

10. One or more non-transitory tangible computer-readable storage media storing computer- executable instructions for performing a computer process on a computing system, the computer process comprising:

receiving an image sequence and corresponding location and orientation data captured by one or more sensors during a scan of tissue;

registering the image sequence based on the location and orientation data to form a map of the tissue; and

generating a diagnostic result based on the registered image sequence.

1 1 . The one or more non-transitory tangible computer-readable storage media of claim 10, wherein the tissue is breast tissue.

12. The one or more non-transitory tangible computer-readable storage media of claim 10, wherein the diagnostic result includes an identification of potentially malignant cancer.

13. The one or more non-transitory tangible computer-readable storage media of claim 10, wherein the diagnostic result is generated based on a comparison of the registered image sequence to one or more previous image sequences.

14. The one or more non-transitory tangible computer-readable storage media of claim 13, wherein the diagnostic result is output for review on a user interface.

15. The one or more non-transitory tangible computer-readable storage media of claim 14, wherein the user interface is displayed on a graphical user interface of a health monitoring device.

16. A system for monitoring health comprising:

a health monitoring application executable by a processor and configured to generate a diagnostic result indicating a potential presence of cancerous cells in tissue, the diagnostic result generated based on data collected by one or more sensors during a scan of the tissue, the data including one or more images representing a hardness of the tissue relative to surrounding tissue.

17. The system for monitoring health of claim 16, wherein the one or more sensors includes at least one of an optical sensor or a static tactile sensor.

18. The system for monitoring health of claim 16, wherein the diagnostic result generated based on a comparison of the one or more images to at least one image corresponding to a previous scan of the tissue.

19. The system for monitoring health of claim 16, wherein the diagnostic result is communicated over a network for review on a user device.

20. The system for monitoring health of claim 16, wherein the diagnostic result is displayed on a user interface of a health monitoring device in substantially real time.