Patent Application
20180242874
Embodiments relate generally to detecting electric cardiovascular, valvular, peripheral, renal, carotid or pulmonary signals and a diverse cardiovascular characteristic to diagnose heart, lung, and other conditions. Embodiments relate more particularly to non-invasive or invasive medical devices, systems and methods for the detection of coronary artery and other diseases using both acoustic and electrical data.
Cardiovascular disease is the leading cause of death in both men and women in the United States, and is a major cause of death throughout the world. According to a 2006 American Heart Association (AHA) report, approximately 80 million people in the United States have heart disease and in 2005, 864,480 people lost their lives. This accounts for 35.3 percent of all deaths or one of every 2.8 deaths in the United States according to the AHA. Cardiovascular cost the health care system approximately $368.4 billion in 2004, accounting for nearly a third of the trillion dollars spent on health care in the United States each year, again according to the AHA. Patient care accounts for 90% of this cost.
The health care system would benefit tremendously by identification of those individuals at high risk for coronary related attacks. Current evidence shows that established cardiac risk factors, such as certain abnormal levels of blood pressure, blood glucose and cholesterol and a history of smoking, possess a limited ability to estimate cardiac risk. In symptomatic patients with suspected cardiovascular disease, there are a variety of tests available to establish diagnosis. It remains a difficult problem, however, as clinical history and additional information is needed to establish the diagnosis, estimate prognosis and guide appropriate treatment. Coronary angiography is considered the “gold standard” for diagnosis, but it is invasive and costly and is an appropriate initial diagnostic study in only a minority of patients.
Other tests include exercise treadmill test, stress echocardiogram, computed tomography, calcium heart scanning and angiography. Each of these tests is ordered by clinicians after a patient is suspected to have Coronary Artery Disease (CAD). These tests vary in their accuracy with angiogram considered the gold-standard. Exercise electrocardiogram (ECG) testing is the most commonly used test because it is simple and inexpensive. This type of test is sometimes also referred to as EKG testing, and one of ordinary skill in the art will recognize that these terms are equivalent to one another. The patient must be able to exercise to at least 85 percent of the predicted maximal heart rate to rule out ischemic heart disease if the test is otherwise negative. For patients who cannot exercise, have baseline ECG abnormalities that could interfere with exercise ECG testing, or in whom the exercise ECG test suggests intermediate risk, a number of alternative noninvasive tests are available including echocardiography with exercise or pharmacologic, radionuclide myocardial perfusion imaging (rMPI), using either planar or photon emission computed tomographic as the imaging method, positron emission tomography (PET) or using coronary calcium scores. Many of these tests are also invasive, time-consuming and expensive, requiring trained personnel and capital equipment.
Moreover, the aforementioned hospital-centric devices are traditionally coupled to a hospital or caregiver network in order to facilitate data transfer and data flow of the recorded data. No built-in network for data transfer and data flow exists for non-hospital-centric devices. As a result, traditional portable devices often are required to contain both sensing and analyzing components, which can be difficult and costly to engineer. Further, field-ready devices often lack the computing power to adequately analyze the recorded data. In other cases, data transfer networks must be created ad-hoc. Therefore, there is a need for improved devices, systems and methods for the detection of coronary artery disease and other diseases.
Embodiments of the present application substantially address or meet the aforementioned needs of the industry. In an embodiment, a system comprises a handheld CAD detection device or other data collection device, and a networked system for storing, securely transferring, and/or processing the recorded data. Further, supplemental devices such as a hub, smartphone, dongle, or other mobile networked device can facilitate data transfer between the data collection device and network-based system.
In embodiments, a handheld CAD detection device can include both acoustic and electrocardiogram (ECG) sensors. By combining, co-considering and/or co-processing ECG and acoustic data, which can be measured concurrently at the same location, more accurate diagnoses of CAD and other conditions can be generated and qualitative results related thereto provided. In some embodiments, the CAD detection device can also include or be coupled with a camera, light sensor, temperature sensor, accelerometer, gyroscope, and/or various other sensors or devices as depicted herein. In embodiments, the aforementioned components can further assist in noise reduction or noise cancellation. In one particular embodiment, the CAD detection device can operate in conjunction with a tablet or other portable computing device communicatively coupled therewith, and noise reduction or noise cancellation also can be provided by features of the tablet or portable computing device.
The above summary is not intended to describe each illustrated embodiment or every implementation of each and every embodiment. The figures and the detailed description that follow more particularly exemplify these embodiments.
Embodiments may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
While embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to be limited to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the appended claims.
Embodiments relate to non-invasive and invasive medical devices, systems and methods for the detection of coronary artery and other diseases in both humans and in veterinary applications. In an embodiment, a handheld coronary artery disease (CAD) detection device is used in a non-invasive manner to determine and provide a qualitative result with respect to whether an internal coronary artery blockage is present. In another embodiment, the CAD device can be used to diagnose valvular, peripheral, carotid, renal or pulmonary disease. In an embodiment, a data transfer system comprises a handheld CAD detection device or other data collection device, and a networked system for storing and processing the recorded data. The handheld CAD detection device can measure both acoustic and electrocardiogram (ECG) signals, and these signals can be used to identify at least one pattern based on both the ECG and acoustic signals to assess physiology and anatomy changes associated with CAD or other disorders that can be sensed by obtaining electrical and acoustic data from the test subject, accurately and efficiently as compared to conventional techniques.
In alternative embodiments, various other anatomical and/or physiological conditions can be observed and diagnosed, or data related thereto can be presented for physician or other medical professional review and analysis. For example, instead of CAD, various other cardiac, pulmonary, vascular, or other conditions can be detected by a combination of sensors similar to those described below. The combination of multiple modes measured simultaneously can be more informative that a single type of information, or even multiple modes measured at separate times. As such, with respect to the embodiments depicted below, the electrical signal mode from ECG sensors combined with acoustic data from the acoustic sensors measured at the same time enhances the ability of the overall system to diagnose CAD, whereas in alternative embodiments acoustic, electrical, temperature, pressure, or any of a number of other modes could be measured concurrently in order to better diagnose other anatomical or physiological conditions.
A block diagram of a data transfer system 100 is depicted in
Data collection device 102 comprises a device for recording, sensing, or otherwise collecting data. In an embodiment, data collection device 102 is configured to collect data from a patient. In embodiments, the patient or test subject can be human or another animal. In an embodiment, data collection device 102 comprises a CAD detection device, as will be described further below. Data collection device 102 can be configured to be wireless and portable so as to collect data in remote places or places without a traditional hospital infrastructure.
Data portal 104 comprises a base station or portal configured to interface to at least one data collection device 102. In embodiments, data portal 104 comprises a desktop computer, data hub, laptop computer, smartphone, personal digital assistant (PDA), tablet, watch, wearable electronic device, or other suitable device. In embodiments, data portal 104 acts as a pass-through to transfer collected data from one or more data collection devices 102 to networked or local computer system 106. In other embodiments, data portal can consolidate, combine, and/or package data, as will be described in more detail with respect to
In one embodiment of a pass-through device, data portal 104 can be a dedicated pass-through device. Dedicated pass-through devices can be left in standby or always-on mode, and serve only to transmit information. Dedicated pass-through devices are distinct, then, from multi-use devices such as smartphones, smartwatches, or other wearable data transmission devices, which are used in alternative embodiments. Plug-in or battery-operated devices can be positioned in a location proximate to expected testing operations. For example, a commercially available hub device can be plugged into a wall outlet in an examination room where data collection device 102 is to be used. Such pass-through devices can be configured to activate upon wirelessly receiving data from associated devices (such as data collection device 102) and pass on the information to a remote server (such as networked or local computer system 106). In embodiments, data transfer can be accomplished via WiFi networks, cellular networks, mobile data networks, wired Ethernet or telephone line networks, or any other transmission medium to networked or local computer system 106.
In embodiments, data collection device 102 and data portal 104 are operably coupled by a communication network and suitable hardware. For example, both data collection device 102 and data portal 104 can comprise Universal Serial Bus (USB), Firewire, Bluetooth, serial, EEPROM, WI-FI, or any other appropriate hardware, software, and suitable interfaces. In embodiments, data collection device 102 is configured with minimal data transmission hardware (i.e., with hardware necessary to transmit to data portal 104), so that data collection device 102 can be more inexpensively and efficiently produced. In such embodiments, data portal 104 can be configured with additional communication hardware to receive data from data collection device 102 and transmit the data to any number of configurations of networked or local computer system 106. In other embodiments, data collection device 102 can include some data storage capability, enabling the storage of a desired number of previous test results, software, or other information.
Networked or local computer system 106 can also include data storage and/or a processing engine to analyze the data provided by data collection device 102 remotely. In embodiments, networked or local computer system 106 is configured to store and process data received from data collection device 102 via data portal 104, and in some embodiments networked or local computer system 106 is configured to store, process and/or aggregate data received from a plurality of data collection devices 102 via one or more data portals 104. In embodiments, networked or local computer system 106 is configured to produce a report, analysis, diagnosis, or other output based on the received data. In embodiments, networked or local computer system 106 therefore comprises an analytics engine. In alternative embodiments, networked or local computer system 106 could be any other networked system, such as a wired system, a remote server, or even a local computer drive, rather than a system that is accessed wirelessly.
Docking station 108 can optionally be used for one or more of a variety of functions in a CAD detection device. For example, docking station 108 can be used to recharge data collection device 102 in embodiments. Alternatively or additionally, docking station 108 can be used to perform diagnostic tests of data collection device 102 in embodiments. Furthermore, docking station 108 can provide a stable, dry, quiet environment in which data collection device 102 can be housed when not in use, in embodiments.
Docking station 108 as shown in
To remove data collection device 102 from docking station 108, at least first retaining member 110a can be detached from base 112. Retaining members 110a and 110b are one of a number of embodiments that can be used to couple data collection device 102 to base 112 for recharging, diagnostic testing, and/or data transfer. In various embodiments, there can be relatively more or fewer retaining members, or even no retaining members, and the retaining members can have alternative configurations, shapes, or sizes than those depicted. In some embodiments, one or more of the retaining members can remain in a fixed position while others are movable or removable (e.g., first retaining member 110a can be movable while second retaining member 110b can be affixed to base 112). In embodiments, retaining members 110a and/or 110b can be attached to base 112 via a hinge or a track system, for example, allowing relative movement between base 112 and the retaining member(s) 110a and/or 110b without complete detachment of retaining members 110a or 110b from base 112.
In embodiments, data collection device 102 includes one or more sensors that can be tuned for low signal levels (such as electrical or acoustic signals from a heart) compared to ambient electromagnetic and acoustic signals. As such, docking station 108 can provide an electromagnetically- and/or acoustically-dampened environment such that when testing is not actively taking place, the sensors are sheltered from potentially damaging signals or substances. Furthermore, as will be described in more detail with respect to
Data collection device 102 of
In embodiments, an intuitive and simple graphical user interface on or communicatively coupled to a handheld CAD detection device provides an interface for controlling and operating the device. Display 116 can output graphical indications of test status, charging status, or other information relating to data transmission, calibration, or data quality, among others. In embodiments, display 116 can display in multiple colors (e.g., blue for a “ready” status, red to indicate an error or that data collection device 102 needs to be recharged). In embodiments, display 116 can comprise a different size or shape. In some embodiments, display 116 facilitates data input as well as display. For example, display 116 or parts thereof can be touch-sensitive.
Inputs 118a-118c provide another mechanism for interacting with and entering information and commands into data detection device 102. A practitioner using data collection device 102 can use inputs 118a-118c to indicate that data collection should begin, or that data is ready for transmission or analysis, for example. In one embodiment, a practitioner or user can turn device 102 on or off via input 118b; and begin, restart or navigate within data collection via forward and back inputs 118a and 118c, respectively. In other embodiments, different or additional information or commands can be provided to device 102 via inputs 118a-118c. At the same time, display 116 can provide visual feedback, prompts and/or directions to the user of the commands received, next user step to be taken, or other information related to device status or operation. In alternative embodiments, there could be relatively more or fewer inputs 118.
Sidewall 120 is a part of data collection device 102 in the embodiment shown in
The embodiment of data collection device 102 as shown in
Microphone 121 can be used to compensate for ambient noise and vibrations incident upon data collection device 102 during testing. In embodiments, microphone 121 can gather information about the ambient acoustic environment and use such data to correct input from other acoustic sensors (such as those associated with acoustic sensor panel 126, described below). Microphone 121 can also be used during calibration procedures when data collection device 102 is positioned in docking station 108, as previously described with respect to
Port 122, as shown in
An ECG sensor panel 124 and an acoustic sensor panel 126 can be arranged on the same surface of data collection device 102 radially inward of flange 127, and are configured to collect electrical and acoustic information from a patient, respectively. ECG sensor panel 124 includes at least one electronic sensor, such as an electrical potential sensor or a Plessey sensor, which can measure electrical activity related to heart function, for example. Acoustic sensor panel 126 includes or covers an acoustic sensor or sensors configured to measure acoustic activity related to heart function, for example. ECG sensor panel 124 can include any of a variety of ECG sensors, including RED DOT electrodes, for example, among other electrodes and/or sensors that will be known to those of skill in the art.
Data from ECG sensor panel 124 and acoustic sensor panel 126 can be combined or used together to generate a more accurate and/or informative diagnosis of heart function and potential disorders than either type of data in isolation. ECG data can be used to determine the anatomical location of a blockage detected by acoustic sensing, for example. ECG sensor panel 124 can measure electronic signals indicative of certain heart conditions such as arrhythmia, ischemia, or infarction, for example, whereas acoustic sensor panel 126 can detect acoustic evidence such as turbulence, leakage, or arrhythmia that are indicative of other heart conditions. Combining, co-processing, and/or co-considering these two data, such as where they are acquired concurrently and at or near the same location(s), can provide a more accurate diagnosis than either type of test in isolation. Accordingly, the acoustic sensor panel 126 is arranged adjacent the ECG sensor panel 124 in embodiments, wherein “adjacent” is defined for purposes of this application as near enough to one another so as to acquire data that correspond to the same test site on the same patient concurrently. For example, in the arrangement shown in
Data from ECG acoustic sensor panel 126 can be compared to the ambient sound measured at microphone 121. Microphone 121 can provide an indication whether a signal at acoustic sensor panel 126 is a result of ambient conditions or whether it is from the patient being tested.
In conventional ECG tests, the ECG sensors may be arranged further from one another, and ground can be at a remote location such as a wire held in the hand of the test subject or a grounded pad or other device on which the test subject sits or lays. Data collection device 102, in contrast, incorporates the electrical ground into the comparatively small footprint of ECG sensor panel 224. In order to prevent the electrical ground value from varying due to the electrical signal from the patient, and to prevent the signal from one of the ECG sensors 228a-228l from affecting the signal at an adjacent ECG sensor 228a-228l, twelve ground contacts 232a-232l are arranged in an interdigitated fashion between the ECG sensors 228a-228l. In embodiments, all twelve ground contacts 232a-232l are electrically connected in a “broken ring” or other arrangement in which the electrical connections between the ground contacts 232a-232l do not form a closed loop that could act as an antenna.
In embodiments, face 429 has a resistivity that is tuned to prevent electrical grounding between the various contacts, while permitting measurement through face 429 of the electrical potential at a variety of locations, or grounding to the test subject. This can be accomplished either by making face 429 of a material having a relatively high resistivity, and/or separating the various ECG and ground contacts behind face 429 sufficiently far from one another, for example. In alternative embodiments, face 429 can be made of an anisotropic material, facilitating current flow through face 429 but not along face 429 between electrical contact points. In still further embodiments, face 429 can appear continuous while containing regions of high and low resistivity, to facilitate current flow through face 429 but not throughout face 429 between electrical contact points.
Referring to
In the embodiment depicted in
In other embodiments, one or both of acoustic sensors 526a and 526b can comprise acoustic or other sensors suitable for data collection, active and/or passive noise cancellation and/or other tasks related to the operation of CAD detection device 500. For example, in one embodiment of noise cancellation, background noise is sampled by at least one sensor 526a or 526b and subtracted from an overall signal in order to cancel noise and improve signal quality. In this and other embodiments, one or both of sensors 526a and 526b and/or related components and circuitry are mechanically potted, or encapsulated, to improve noise cancellation. In embodiments, one or both of sensors 526a and 526b are electrically shielded to reduce noise. Still other sensors in addition to sensors 526a and 526b also can be included in device 500, even though they are not specifically depicted in
Automatic signal strength detection circuitry and signal processing techniques can also be implemented in embodiments to improve signal quality. For example, in one embodiment, a signal kernel or shape is determined from signal samples and compared with an overall signal or pattern to determine whether the sample fits. If not, new data can be collected, existing data can be otherwise processed, and/or detection device 500 can be repositioned, among other tasks.
Therefore, active noise cancellation can be implemented in embodiments of CAD detection device 500 as described above and elsewhere herein. Passive noise cancellation can be implemented in combination with active noise cancellation, or on its own, in other embodiments. Materials such as, but not limited to, rubber, foam, sponge, glass fiber, ceramic fiber, mineral fiber, vinyl, tape, or sound-absorbing coatings and pastes or combinations thereof can be disposed proximate one or both of acoustic sensors 526a and 526b or otherwise suitably arranged on or within device 500 in order to passively reduce noise.
In embodiments, one or both of acoustic sensors 526a and 526b or another sensor of device 500 can comprise pressure sensors or other sensors suitable for sensing the pressure applied by a user to CAD detection device 500 in preparation for or during patient scanning. In embodiments, one or both of sensors 526a and 526b can comprise pressure sensors or other sensors suitable for sensing the pressure applied by a user to detection device 500 in combination with the ability to collect data related to the presence or absence of a turbulent pressure wave in a coronary artery. In other embodiments, an additional sensor or plurality of sensors is configured for sensing the pressure applied by a user to detection device 500 in preparation for or during patient scanning.
In embodiments, the pressure applied by a user is measured and compared against a minimum value representative of a typical amount of minimum pressure to establish a signal, and a maximum value representative of a typical amount of maximum pressure so as to not max out the measured signal. If the measured pressure exceeds the maximum value, an error message can be displayed to the user via a user interface. Likewise, if the measured pressure is below the minimum value, an error message can be displayed to the user via the user interface. Other threshold minimum and maximum values can also be used, depending on the patient, user, or other appropriate factors.
ECG sensors 528a-528n can provide data relating to electrical activity in the heart. In one embodiment, there can be six ECG sensors 528a-528n. The electrical activity of the heart or other anatomical feature of a human or animal can be modeled by analyzing the electrical outputs of each of the ECG sensors 528a-528n at each of the positions identified in a sequence guide (see, e.g.,
Memory 532, as previously described with respect to the memory (132) of
Power supply 534 can comprise a battery in embodiments, such as a rechargeable battery or a replaceable battery. Rechargeable power supply 534 can be inductance-style, two-pin, charge by computer, and/or charge by AC wall outlet, or some other suitable charging configuration. In embodiments, power supply 534 can be powered or recharged through inductive charging. Power supply 534 can also be configured to allow for multiple different charging schemes. For example, CAD detection device 500 can interface with a charging station by physical coupling or cable, and/or CAD detection device 500 can couple by USB or other cable to a computer, docking station, wall outlet or other source of power. In embodiments, one power supply 534 is electrically shielded to reduce noise.
Controller 536 controls the operation of CAD detection device 500. During scanning, controller 536 can control a graphical user interface (GUI), a timer and the general operation of CAD detection device 500. In embodiments, the GUI is electrically shielded to reduce noise. Controller 536, via the GUI and/or an audible indicator, can also prompt a user to carry out various tasks, such as to apply CAD detection device 500 to one or more of patient scan areas in a sequence, to move on to a next guide area, tag or patient area, to rescan a particular guide area, tag or patient area, to reposition CAD detection device 500 if data of sufficient quality is not detected, to recharge CAD detection device 500 and other functions. CAD detection device 500 further comprises a timer, such as part of controller 536, for each scan to ensure that sufficient data is collected at each scan site. In one embodiment, this timer can automatically start as soon as data of a sufficient quality is detected by first acoustic sensor 526a, though other procedures can be used in other embodiments.
Controller 536 can be subservient to and/or operate in conjunction with an external controller coupled by wire or wirelessly in embodiments. In embodiments, controller 536 can carry out processing of collected data, for example to determine a presence of coronary artery disease based on data sampled by at least one of sensors 526a and 526b at the patient data acquisition locations associated with an identification areas guide (see, e.g.,
Communication circuitry 538 is configured to transfer data to and from CAD detection device 500. For example, after scan data is collected for a particular patient and stored in memory 532, the raw scan data can be packaged and transferred wired or wirelessly to, for example, data portal 104 or networked or local computer system 106 for processing and determination of whether CAD may be present.
In another embodiment, CAD detection device 500 optionally further comprises a camera 540, photo or optical sensor, or other similar device. In embodiments, camera 540 can be configured to read or detect barcodes, such as one or more QR codes on a sequence guide (see, e.g.,
In another embodiment, CAD detection device 500 optionally further comprises a light sensor 542. In embodiments, light sensor 542 can be utilized to detect the proximity of CAD detection device 500 to the body of the patient or to a docking station (e.g., docking station 608 previously described with respect to
In another embodiment, CAD detection device 500 optionally further comprises a temperature sensor 544. In embodiments, temperature sensor 544 can be utilized to detect the proximity of CAD detection device 500 to the body of the patient. For example, a lower temperature will be detectable by temperature sensor 544 when CAD detection device 500 is further from the patient. Likewise, a higher temperature will be detectable by temperature sensor 544 when CAD detection device 500 is proximate the patient. Such temperature sensing can be utilized to properly place and position CAD detection device 500.
In another embodiment, CAD detection device 500 optionally further comprises one or more accelerometers 546. In embodiments, accelerometer 546 is configured to detect acceleration of CAD detection device 500. For example, if accelerometer 546 detects an acceleration when CAD detection device 500 is in a data sense mode, it can be determined that CAD detection device 500 has moved or shifted during sensing and the data measured during that point may have errors or otherwise be incorrect. Such acceleration sensing can be utilized to properly place and position CAD detection device 500. In embodiments, an indication of a shift can be provided to the user via display 116 of CAD detection device 500. In embodiments, accelerometers 546 can also be used for acoustic detection.
In an embodiment, CAD detection device 500 optionally further comprises one or more gyroscopes 548. In embodiments, gyroscope 548 is configured to detect an orientation or change in orientation of CAD detection device 500. For example, if gyroscope 548 detects a change in orientation of CAD detection device 500 when CAD detection device 500 is in a data sense mode, it can be determined that CAD detection device 500 has tilted during sensing and the data measured during that point may have errors or otherwise be incorrect. Such orientation sensing can be utilized to properly place and position CAD detection device 500. In embodiments, an indication of a tilt can be provided to the user via the GUI of CAD detection device 500.
In an embodiment of CAD detection device 500 comprising gyroscope 548, noise determination can be conducted by determination of orientation or movement sensed by gyroscope 548. In embodiments, based on the amount of movement sensed by gyroscope 548, additional determination can be made of the source of the noise, such as lung noise, digestive noise, or movement of the device. In such embodiments, CAD detection device 500 can include only first acoustic sensor 526a, and need not include second acoustic sensor 526b for noise reduction or noise cancellation.
In an embodiment, CAD detection device 500 optionally further comprises an SD card port configured to receive an SD card or other portable memory. In such embodiments, CAD detection device 500 is effectively infinitely expandable such that an unlimited number of data sets can be stored. In embodiments, embedded non-volatile memory can be used in addition to or instead of those types of memory described herein.
In embodiments, CAD detection device 500 can be configured for gain control. In an embodiment, gain control can be automated. For example, an impedance measurement can detect abdominal loading or feedback and the gain adjusted appropriately. Gain can therefore be modified based on an impedance feedback. In embodiments, gain tuning or control can be based at least in part on data (e.g., patient weight, BMI, measurements, etc.) downloaded from an electronic health record (EHR). In embodiments, CAD detection device 500 can be pre-calibrated before use. Gain control can also based on real time acoustic measurement in embodiments, by analyzing a predetermined duration of acoustic signal (such as a few seconds) before any signal is stored into memory or analyzed.
Referring now to
Base 612 is similar to base 112 previously described with respect to
Base 612 is shaped to interface with a CAD detection device. For example, as previously depicted with respect to
Base 612 can be connected to wired or wireless networks in embodiments, such that data at base 612 can be transmitted to a remote location. Base 612 can also include a cord and plug (not shown) in order to provide power for recharging a CAD detection device, in embodiments, or base 612 can contain a battery sufficient to recharge CAD detection device. In embodiments in which base 612 comprises a cord and plug, the plug can comprise a removable/interchangeable portion such that plug configurations used in different countries or regions can be swapped in and out of the plug easily and conveniently. In these embodiments, docking station 608 and device 102 can be compatible with and rated for voltages from 110V to 240V such that no voltage converter or transformer is necessary for operation anywhere in the world.
In alternative embodiments, such as is depicted in
Acoustic pad or emitter 650, pins 652, and electromagnetic emitter 654 can be used in diagnostics, calibration, and/or data transfer to and from a CAD detection device, in embodiments. For example, CAD detection device 102, which is highly sensitive to noises and pressure changes, can be calibrated and checked for damage or changes in sensitivity or other characteristics over time by positioning the CAD detection device with its acoustic sensor (for example, acoustic sensor panel 126) adjacent to acoustic pad or emitter 650. Acoustic pad or emitter 650 can perform diagnostic checks of acoustic sensor panel 126 by emitting a test noise or noises, and verifying that CAD detection device measures the same signal that was output by acoustic pad or emitter 650. In some embodiments, acoustic pad or emitter 650 can comprise a sound tranducer.
In embodiments, acoustic pad or emitter 650 can also be used for calibration of acoustic sensors on the CAD detection device. In some embodiments, such as the embodiment previously described with respect to
Referring to the embodiment of
In embodiments, docking station 608 can have various numbers of acoustic pads or emitters 650, sets of pins 652, and/or electromagnetic emitters 654. In the embodiment shown in
When testing or checking of device 102 by docking station 608, data can be collected and stored locally by docking station 608, though in other embodiments the data can be collected by or transmitted to, and stored by, device 102. The data then can be sent as a packet to a remote server or other location for analysis or review, and status or results information can be provided to a user via device 102 and/or docking station 608. For example, display 616 can display an icon (e.g., a check mark, plus sign, smiling emoticon or emoji, or other symbol or icon generally understood to indicate a positive result or status), text (e.g., “okay,” “OK,” “pass,” etc.), color (e.g., green), light or sound pattern, or other output when the condition or operation of device 102 is tested and confirmed to be in order. Display 616 can display a different icon (e.g., an “X,” a sad emoticon or emoji, or some other symbol or icon generally understood to indicate a negative results or status), text (“not okay,” “fail,” “contact customer service,” etc.), color (e.g., red), light or sound pattern, or other output when the condition or operation of device 102 is tested and confirmed to be in out of order or requiring attention. In other embodiments, some or all of the data analysis or diagnostics of device 102 can be carried out locally, without requiring data to be transmitted remotely.
Referring now to
In embodiments, sequence guide 756 can be coated in an anti-microbial coating for protection against disease. In embodiments, anti-microbial materials can be embedded within the layers of sequence guide 756.
In an embodiment, sequence guide 756 is initially folded or otherwise secured so that two or more sides can be secured with a seal 758, as depicted in
In another embodiment, sequence guide 756 can be electromagnetically shielded such that data from wireless chips cannot be read from outside sequence guide 756. In an embodiment, the cover of sequence guide 756 is integrated with a shield. In an embodiment, the shield comprises conductive or magnetic materials, such as sheet metal, metal screen, and metal foam, or electromagnetically integrated paint or other coating.
In an embodiment of manufacturing sequence guide 756, RFID, NFC, or other wireless chips can be laid in a strip on the relevant scanning area identification pads. Such strip-based manufacturing saves time and money in producing sequence guide 756.
In an embodiment, sequence guide 756 can be integrated with a single removable patch. The patch can be removed from its coupling to sequence guide 756 and applied to a patient. In an embodiment, the patch comprises a sensor, circuitry, guide portion or other component at each relative location necessary to make a determination on the disease the system is intended to diagnose, such as coronary artery disease. For example, a single patch can be shaped to encompass all four locations (for example, those shown in
Sequence guide 756 can further comprise, in an embodiment, a display screen for displaying the results of the analysis or diagnosis of a particular disease. In other embodiments, a portion of sequence guide 756 comprises invisible ink that can likewise display the results of the analysis or diagnosis of a particular disease.
In still other embodiments, and referring to
Sequence guide 756, via the app and tablet 770, can present user input/output (I/O) features, such as user authentication I/Os (e.g., login/password, biometrics such as fingerprint or retinal scanning, or facial or voice recognition), as well as buttons or other features that look similar to inputs 118a-118c of device 102 for control of device 102 during use. In some embodiments, tablet 770 can display an image of a device 102 such that a user can press buttons on the image (via a touchscreen of tablet 770) with the same effect of having pressed the same buttons physically located on device 102. In other embodiments, an interactive version of sequence guide 756 is displayed, such that a user can touch “START” on sequence guide 756 via a touchscreen of tablet 770, and the command wirelessly communicated to device 102 such that device 102 anticipates a patient scanning sequence to begin or automatically begins collecting data. In still other embodiments, voice recognition of user commands via tablet 770 can be implemented.
In some embodiments, tablet 770 can provide user calibration features. For example, tablet 770 can comprise a gyroscope and/or accelerometer to calibrate hand movement or vibration of a user via tablet 770 in order to improve data collection via device 102. In other embodiments, these features (e.g., a gyroscope and/or accelerometer) can be used for user training so that users can receive feedback regarding positioning, pressure, movement and use of device 102 before using it with a patient. This feedback can be haptic, visual and/or audible and include an auto-prompt for user adjustment related to one or more of user grip, device pressure on the patient, tilt, etc. In these cases, tablet 770 can comprise one or more separate apps for training, calibration, and other features and functions.
During patient scans or other operation, tablet 770 can provide audible and/or visual prompts to a user. For example, tablet 770 can prompt a user to move to a next scanning area on a patient when sufficient data at a current location is obtained, or to rescan or restart scanning at a location if insufficient or bad (e.g., noisy or low quality) data is being collected. In such a situation, tablet 770 and/or device 102 can stop collecting data so that memory, battery and other resources are not used to collect, store or transmit bad data. As previously discussed, device 102 can comprise microphone 121, though in other embodiments tablet 770 can, additionally or alternatively, also comprise or couple with (e.g., via an external jack or port) a microphone or other sensor to detect or measure ambient noise that could affect operation of device 102. Tablet 770 can be configured to cause device 102 to stop collecting data in noisy situations and/or to provide feedback to a user (e.g., via a noise meter displayed on tablet 770) so that noise can be reduced and data collection restart or continue.
In still other embodiments, tablet 770 can comprise or be coupled with other sensors or devices to improve or enhance operation of device 102. For example, in an embodiment one or more ECG sensors can be incorporated in or coupled with tablet 770 to be used in cooperation with ECG or other sensors of device 102. Six ECG sensors can be located on device 102, and six ECG sensors can be located on or coupled with tablet 770 to achieve a twelve-sensor ECG array. These and other sensors (e.g., microphone, temperature, etc.) can be incorporated directly in tablet 770 or coupled with tablet 770, wired (e.g., via an external port or jack of tablet 770) or wirelessly (e.g., via BLUETOOTH, WiFi, or another wireless communications protocol).
In another embodiment, and referring to
Tablet 770 also can function as an extension of display 616 of device 102. For example, display 616 can display an icon or prompt, and tablet 770 can display additional and more detailed information. This feature can provide advantages to users without sacrificing battery or other limited resources of device 102.
Once sufficient patient data is collected, data can be sent from tablet 776 (or, additionally or alternatively, from device 102 or docking station 108) to networked or local computer system 106. In some embodiments, this can be accomplished via data portal 104 (see
When a report is complete, however it is processed and obtained, the report can be sent back to and presented via tablet 770. Here, too, encryption and decryption techniques can be used when transferring the report and related data and information. In some embodiments, the report can be automatically displayed on tablet 770 when it is available. In other embodiments, tablet 770 can access and display a remote report, without the report having to be sent to tablet 770. In still other embodiments, the report can, additionally or alternatively, be sent (e.g., via email) to another address or location remote from tablet 770. In a further embodiment, the report or other results or information related to a patient can be sent directly to or incorporated in a patient electronic medical record (EMR).
ECG scan data, such as the scan data depicted in
The ECG scan data shown in
In embodiments, ECG sensor data and acoustic sensor data can be combined or co-considered to provide an indication of a particular disorder, or of a likelihood of a particular disorder, or simply that the results are abnormal. In some cases, the data can indicate that subsequent angiography or even surgical intervention is recommended.
In embodiments, networked or local computer system 106 (
As shown in
The systems described herein, including system 800, provide contemporaneously-acquired electrical and acoustic data. This contemporaneous data in two modes can diagnose cardiac and/or pulmonary conditions quickly and accurately, without the need for invasive and expensive alternatives such as angiography. Embodiments are small, portable, and versatile, and can be used for both human medical evaluations and in veterinary applications.
As used herein, the term “processor” can refer to any suitable programmable device that accepts digital data as input, is configured to process the input according to instructions or algorithms, and provides results as outputs. In an embodiment, the processor can be a central processing unit (CPU) configured to carry out the instructions of a computer program. In other embodiments, the processor can be an Advanced RISC (Reduced Instruction Set Computing) Machine (ARM) processor or other embedded microprocessor. In other embodiments, the processor comprises a multi-processor cluster. The processor is therefore configured to perform at least basic selected arithmetical, logical, and input/output operations.
Memory can comprise volatile or non-volatile memory as required by the coupled processor to not only provide space to execute the instructions or algorithms, but to provide the space to store the instructions themselves. In embodiments, volatile memory can include random access memory (RAM), dynamic random access memory (DRAM), or static random access memory (SRAM), for example. In embodiments, non-volatile memory can include read-only memory, flash memory, ferroelectric RAM, hard disk, floppy disk, magnetic tape, or optical disc storage, for example. The foregoing examples in no way limit the type of memory that can be used, as these embodiments are given only by way of example and are not intended to limit subject matter hereof In other embodiments, the memory comprises a plurality of memory.
Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the invention.
Persons of ordinary skill in the relevant arts will recognize that the invention may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the invention may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the invention may comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art.
Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
For purposes of interpreting the claims for the present invention, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
The present application claims the benefit of U.S. Provisional Application No. 62/211,545 filed Aug. 28, 2015, which is hereby incorporated herein in its entirety by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US16/48937 | 8/26/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62211545 | Aug 2015 | US |
