Patent Application
20240358326
Embodiments of the invention relate generally to physiological monitoring systems. More particularly, the invention relates to respiratory, cardiovascular, organ, digestive, joint and physiological monitoring systems and wearable devices usable in methods in various fields, such as medical, athletic, public safety, wellness, entertainment, data acquisition, and the like.
The following background information may present examples of specific aspects of the prior art (e.g., without limitation, approaches, facts, or common wisdom) that, while expected to be helpful to further educate the reader as to additional aspects of the prior art, is not to be construed as limiting the present invention, or any embodiments thereof, to anything stated or implied therein or inferred thereupon.
Physiological sensors have long been known and widely used for certain medical and health related applications. Various physiological sensors embedded in textile or garments, sometimes called portable or wearable sensors, have been described before in publications and patents (Portable Blood Pressure in U.S. Pat. No. 4,889,132; Portable device for sensing cardiac function in U.S. Pat. No. 4,928,690; Heart rate monitor in garment in U.S. Pat. No. 7,680,523 B2). The term “wearable sensors” is now commonly used to describe a variety of body-worn sensors to monitor activity, environmental data, body signals, biometrics, health related signals, and other types of data.
As used herein, “plethysmography”, and its derivative words, is the measurement of changes in volume within an organ or whole body, or a cross-sectional area of the body when the body is constant in height. “Inductive plethysmography” is a plethysmographic measurement based on determination of an inductance or a mutual inductance. A “plethysmographic signal” is a signal generated by plethysmography, and specifically by inductive plethysmography. The cross-sectional area of the body measured by a plethysmograph may include, singly or in combination, the chest, abdomen, neck, or arm, for example.
Respiration measurements can provide insight into an individual's wellbeing. Respiration measurements can be indicative of physiological and/or mental states of an individual, as well as prognostic with regard to diagnosis of medical conditions. For example, respiration measurements can provide insight into an individual's stress levels, and can be evidential of more serious pulmonary disorders, such as disorders associated with chronic obstructive pulmonary disease (COPD) and asthma.
Traditionally, however, respiration monitoring has occurred in a clinical setting, contributing to the development of respiration monitoring devices that are non-ambulatory, lack portability, and are difficult to use. Other respiration monitoring devices include those that are tethered to another device for full functionality.
These conventional devices include smart devices (such as smartphones) tethered to sensors with or without data-loggers where meaningful processing of the sensor data occurs on the smart device. Present shortcomings include wearables that lack the ability to detect, data-log and analyze acoustic physiological signals, wearables that have to be embodied in vests or some other system larger than the intended wearable, wearables that have wired or wireless connections to another component or device housed separately from the wearable, and wearables that attempt to detect signals that infer that the acoustic physiological signals are present.
While wearables have been used for basic measurements, measurements taken from one wearable are often analyzed in a vacuum, without regard to other parameters that may be sensed or detected. This limits the usability of a physiological wearable. Moreover, many wearables provide specific data without any data analysis that may be useful for detecting certain conditions, monitoring individuals, detecting personal wellness, monitoring athletes, providing entertainment, and the like.
The sounds that our organs make have been used in diagnosing ailments for centuries. The most typical form of this type of audio collection has been the stethoscope. Over time it has evolved to include various interchangeable parts that enhance sounds as no one configuration is suitable for all organ sounds.
The use of organ sounds has limitations, most of which are organ sounds differ from patient to patient based on patient size, learning to identify organ sounds requires many hours of practice, recognizing and identifying patient problems that are less frequent is difficult and dissemination of audio learning materials have always been impractical due to significant differences between playback of recorded audio and stethoscope audio.
As time progresses, reliance on organ sounds for diagnosis is diminishing and being supplemented and or replaced by other tests and or biomarkers. The need for extensive training and development of experience have primarily driven this push. The stethoscope is now used for a limited range of diagnoses.
While organ sounds continue to be a rich source of data making diagnosing faster and simpler, advancements in the capture of organ sounds have been slow. This may be attributed to many things, but the two major ones are cultural (a stethoscope alternative just does not sound the same way as a stethoscope) and technological (audio processing continues to require complex and energy demanding solutions).
The electronic stethoscope which initially was thought to make capturing the organ sounds easier using one device with no physical interchangeable parts highlighted the cultural issue and today it continues to be a premium product used only by a small percentage of physicians.
In all of these advances, the thought has been to replicate the original usage i.e. a field device for capturing data in the present for immediate diagnosis. This diagnosis could range from immediate action required to being placed on a course for change over time.
In view of the foregoing, it is clear that there is a need for methods for using physiological monitoring systems for purposes beyond which are currently contemplated in the art.
Embodiments of the present invention provide a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable, wherein the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues.
Embodiments of the present invention provide a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable, wherein the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues, wherein the device performs real-time, continuous monitoring measured in whole days without a need for removal from the user; and the at least one auscultation data signals are detected and recorded directly from a surface of the user.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims.
Some embodiments of the present invention are illustrated as an example and are not limited by the figures of the accompanying drawings, in which like references may indicate similar elements.
Unless otherwise indicated illustrations in the figures are not necessarily drawn to scale.
The invention and its various embodiments can now be better understood by turning to the following detailed description wherein illustrated embodiments are described. It is to be expressly understood that the illustrated embodiments are set forth as examples and not by way of limitations on the invention as ultimately defined in the claims.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
In describing the invention, it will be understood that a number of techniques and steps are disclosed. Each of these has individual benefit and each can also be used in conjunction with one or more, or in some cases all, of the other disclosed techniques. Accordingly, for the sake of clarity, this description will refrain from repeating every possible combination of the individual steps in an unnecessary fashion. Nevertheless, the specification and claims should be read with the understanding that such combinations are entirely within the scope of the invention and the claims.
In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be evident, however, to one skilled in the art that the present invention may be practiced without these specific details.
The present disclosure is to be considered as an exemplification of the invention, and is not intended to limit the invention to the specific embodiments illustrated by the figures or description below.
Devices or system modules that are in at least general communication with each other need not be in continuous communication with each other, unless expressly specified otherwise. In addition, devices or system modules that are in at least general communication with each other may communicate directly or indirectly through one or more intermediaries.
A “computer” or “computing device” may refer to one or more apparatus and/or one or more systems that are capable of accepting a structured input, processing the structured input according to prescribed rules, and producing results of the processing as output. Examples of a computer or computing device may include: a computer; a stationary and/or portable computer; a computer having a single processor, multiple processors, or multi-core processors, which may operate in parallel and/or not in parallel; a general purpose computer; a supercomputer; a mainframe; a super mini-computer; a mini-computer; a workstation; a micro-computer; a server; a client; an interactive television; a web appliance; a telecommunications device with internet access; a hybrid combination of a computer and an interactive television; a portable computer; a tablet personal computer (PC); a personal digital assistant (PDA); a portable telephone; application-specific hardware to emulate a computer and/or software, such as, for example, a digital signal processor (DSP), a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), an application specific instruction-set processor (ASIP), a chip, chips, a system on a chip, or a chip set; a data acquisition device; an optical computer; a quantum computer; a biological computer; and generally, an apparatus that may accept data, process data according to one or more stored software programs, generate results, and typically include input, output, storage, arithmetic, logic, and control units.
“Software” or “application” may refer to prescribed rules to operate a computer. Examples of software or applications may include: code segments in one or more computer-readable languages; graphical and or/textual instructions; applets; pre-compiled code; interpreted code; compiled code; and computer programs.
The example embodiments described herein can be implemented in an operating environment comprising computer-executable instructions (e.g., software) installed on a computer, in hardware, or in a combination of software and hardware. The computer-executable instructions can be written in a computer programming language or can be embodied in firmware logic. If written in a programming language conforming to a recognized standard, such instructions can be executed on a variety of hardware platforms and for interfaces to a variety of operating systems. Although not limited thereto, computer software program code for carrying out operations for aspects of the present invention can be written in any combination of one or more suitable programming languages, including an object oriented programming languages and/or conventional procedural programming languages, and/or programming languages such as, for example, Hypertext Markup Language (HTML), Dynamic HTML, Extensible Markup Language (XML), Extensible Stylesheet Language (XSL), Document Style Semantics and Specification Language (DSSSL), Cascading Style Sheets (CSS), Synchronized Multimedia Integration Language (SMIL), Wireless Markup Language (WML), Java™, Jini.™., C, C++, Smalltalk, Python, Perl, UNIX Shell, Visual Basic or Visual Basic Script, Virtual Reality Markup Language (VRML), ColdFusion™ or other compilers, assemblers, interpreters or other computer languages or platforms.
Computer program code for carrying out operations for aspects of the present invention may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the “C” programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). The program code may also be distributed among a plurality of computational units wherein each unit processes a portion of the total computation.
The Internet is a worldwide network of computers and computer networks arranged to allow the easy and robust exchange of information between computer users. Hundreds of millions of people around the world have access to computers connected to the Internet via Internet Service Providers (ISPs). Content providers (e.g., website owners or operators) place multimedia information (e.g., text, graphics, audio, video, animation, and other forms of data) at specific locations on the Internet referred to as webpages. Web sites comprise a collection of connected, or otherwise related, webpages. The combination of all the web sites and their corresponding webpages on the Internet is generally known as the World Wide Web (WWW) or simply the Web.
Aspects of the present invention are described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.
Further, although process steps, method steps, algorithms or the like may be described in a sequential order, such processes, methods and algorithms may be configured to work in alternate orders. In other words, any sequence or order of steps that may be described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously.
It will be readily apparent that the various methods and algorithms described herein may be implemented by, e.g., appropriately programmed general purpose computers and computing devices. Typically, a processor (e.g., a microprocessor) will receive instructions from a memory or like device, and execute those instructions, thereby performing a process defined by those instructions. Further, programs that implement such methods and algorithms may be stored and transmitted using a variety of known media.
When a single device or article is described herein, it will be readily apparent that more than one device/article (whether or not they cooperate) may be used in place of a single device/article. Similarly, where more than one device or article is described herein (whether or not they cooperate), it will be readily apparent that a single device/article may be used in place of the more than one device or article.
The term “computer-readable medium” as used herein refers to any medium that participates in providing data (e.g., instructions) which may be read by a computer, a processor or a like device. Such a medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media include, for example, optical or magnetic disks and other persistent memory. Volatile media include dynamic random access memory (DRAM), which typically constitutes the main memory. Transmission media include coaxial cables, copper wire and fiber optics, including the wires that comprise a system bus coupled to the processor. Transmission media may include or convey acoustic waves, light waves and electromagnetic emissions, such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASHEEPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read.
Various forms of computer readable media may be involved in carrying sequences of instructions to a processor. For example, sequences of instruction (i) may be delivered from RAM to a processor, (ii) may be carried over a wireless transmission medium, and/or (iii) may be formatted according to numerous formats, standards or protocols, such as Bluetooth, TDMA, CDMA, 3G.
Where databases are described, it will be understood by one of ordinary skill in the art that (i) alternative database structures to those described may be readily employed, (ii) other memory structures besides databases may be readily employed. Any schematic illustrations and accompanying descriptions of any sample databases presented herein are exemplary arrangements for stored representations of information. Any number of other arrangements may be employed besides those suggested by the tables shown. Similarly, any illustrated entries of the databases represent exemplary information only; those skilled in the art will understand that the number and content of the entries can be different from those illustrated herein. Further, despite any depiction of the databases as tables, an object-based model could be used to store and manipulate the data types of the present invention and likewise, object methods or behaviors can be used to implement the processes of the present invention.
Embodiments of the present invention may include apparatuses for performing the operations disclosed herein. An apparatus may be specially constructed for the desired purposes, or it may comprise a general-purpose device selectively activated or reconfigured by a program stored in the device.
Unless specifically stated otherwise, and as may be apparent from the following description and claims, it should be appreciated that throughout the specification descriptions utilizing terms such as “processing,” “computing,” “calculating,” “determining,” or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data represented as physical, such as electronic, quantities within the computing system's registers and/or memories into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices.
In a similar manner, the term “processor” may refer to any device or portion of a device that processes electronic data from registers and/or memory to transform that electronic data into other electronic data that may be stored in registers and/or memory or may be communicated to an external device so as to cause physical changes or actuation of the external device.
Broadly, embodiments of the present invention provide a physiological monitoring system that can use physiological wearable monitors to collect and/or detect various parameters, such as cough, wheeze, heart rate, skin temperature, activity, respiration rate, skin impedance, electro-cardiogram data, blood pressure, galvanic skin response, organ and joint sounds, digestive system sounds, and the like. One or more of these parameters, or other such parameters, may be used in methods of the present invention in the fields of lung cancer, physiotherapy, monitoring disabled or challenged individuals, monitoring end of life conditions, monitoring breathing gas usage, monitoring patients and individual wellness, data acquisition, athletic sports monitoring, athletic sports entertainment, virtual reality feedback, telemedicine, hospital aid, illness detection and its severity, and public service, as examples. Such methods can use data from one or more wearable devices with the appropriate data processing to present the user with the appropriate analysis.
The wearables usable in the methods of the present invention can take various forms. In some embodiments, the wearable may be placed directly in contact with the human body, such as by adhesive to the wearer's skin. The description below describes some embodiments of a wearable usable in the methods of the present invention. The methods discussed herein, however, are not limited to any particular type of wearable, mounting location, or mounting configuration.
Further, embodiments of the present invention relate to a monitoring and alerting system for use in any condition, especially those with a respiration, cardiovascular, digestive, organ or joint component. Signs and symptoms, as well as supporting physiological functions, are tracked against the user's baseline and alerts the user when there is a worsening trend. The system is self-contained in a wearable that detects and logs the signals, analyzes them and generates alerts. The wearable is untethered during use and may be attached to the body in various manners, such as with adhesives, clothing, clips, belts, chains, necklaces, car pieces, clothing circuits or the like. Information can further be transmitted both wirelessly and via wire to devices, cloud storage, or the like.
Currently, there are no continuous monitoring, miniature, ambulatory, autonomous respiratory devices that detect and measure conventional symptoms similar to general office practice equipment, such as a thermometer, a stethoscope, a blood oxygen meter and a sphygmomanometer. Moreover, there is currently no continuous monitoring, miniature, ambulatory, autonomous devices that measures a user's temperature, blood oxygen concentration, pulse and blood pressure while simultaneously recording activity information that is further analyzed to identify abnormalities. Further, there are currently no continuous monitoring, miniature, perambulatory, autonomous devices that accomplishes at least two distinct measurements and determines the user's baseline with the intent to indicate when symptoms are worsening as compared with the self-generated baselines. The present invention provides devices, systems, and methods that provide these features that were previously lacking in the art.
Moreover, currently, there are no ambulatory devices for extended real time use that can detect and monitor an array of body signals, where acoustic signals are key, such as where acoustic signals need to be detected and recorded directly from the surface of the body (i.e., contact sensing) between the waist and the base of the neck. This is different from attempting to collect audio signals via a device or microphone loosely attached/worn to the body, or on an appendage or on the neck or as an earpiece. Also, there are no ambulatory devices where the acoustic signals are accompanied by motion of the upper torso so that this motion is also detected and matched with the audio for time correlation. The available devices on the market either measure a variety of signals except acoustic or short term acoustic only. The closest devices are point of care or bedside implemented.
Acoustic signals are key for many applications ranging from cardiology use to respiratory. To date, almost all cardiology applications are implemented as non-acoustic systems, but this now makes it possible for acoustic implementation.
These implementations are for the gathering of data over a period of time to aid in treatment and or diagnosis. The analysis is dependent on the end user processing the signals accordingly. Additionally, it is for use in a nonprofessional capacity for general wellness, the applications of which are numerous and growing each day.
The device and system of the present invention can continuously detect, measure, record, data-log, analyze and compare with benchmarks, acoustic physiological signals, namely cardio pulmonary signals, digestive signals, organ and joint sounds, or the like, as well as temperature and reflectance derived blood oxygen levels and capture the corresponding activity and motions in a miniature, ambulatory, autonomous, wearable device. The device and system of the present invention can (1) provide real time monitoring of multiple systems inclusive of acoustic physiological signals; (2) capture active data in real time; (3) have the ability to transmit meaningful data to device(s) over a broad area; (4) have a relatively small form factor; and (5) have continuous run time measured in whole days.
Aspects of the present invention can provide systems, devices and methods for listening to various parts of the body just like when a physician sounds organs. As such these additional areas included but are not limited to (1) sounds of the heart, e.g., blood flow through the heart, valve operation. These sounds are used to identify if valves are operating properly versus leaking, good pumping action, valve replacements are functioning positively, and the like; (2) sounds of the vascular system. These sounds indicate if there are restrictions, excessive dilation, and the like; (3) sounds of the gut from stomach to bowels. These sounds help to determine if there is excessive bloating, obstructions, digestion activity, and the like; (4) sounds of the joints. These sounds determine if there is wear, or if joint replacements are functioning smoothly; and (5) sounds of the respiratory system. These sounds are used to identify, for example, apnea especially during sleep
The devices and methods can provide the ability to collect a lot of data over time due to specific operation of the device as described herein. In some cases, apart from the plurality of sensors, the devices and methods of the present invention provide for the possibility for the collection of multiple organ data simultaneously. This is new, as most people focus on one organ at a time, as this is the traditional and taught way.
Aspects of the present invention seek to capture the sound of a particular organ (or multiple organs) over time, with or without event classification, with the aim of establishing a trend. The trend could be any of a baseline (best, or elevated) to a change of state—be it worsening or recovering. The initial abnormal sound of an organ can be the only evidence of a health condition until that condition begins to affect the functioning of the body. For example, a heart murmur could be heard before the impact of the condition triggers another biomarker. Capturing data conveniently and more frequently than the norm, where the norm is during an annual checkup and or a sick visit, presents the opportunity to capture deviations from a baseline that could indicate a change. The change could be any of onset of a condition, a pattern that, if investigated, could explain bouts of poor health or the potential for better health. Identifying the onset of a condition provides a larger window of opportunity to treat the condition starting with minimally invasive to arresting the condition before worsening.
Aspects of the present invention provide devices and methods for capturing auscultation data, with or without event classification, in a portable, wireless, and minimally invasive manner with the least amount of ambient and external noise.
Someone skilled in the art, as evidenced by the lack of such continuous audio capture devices specifically for the person, would not normally think of this solution as the mindset is to use auscultation in the way that it has been used for centuries. While there are devices that capture organ sounds externally, i.e., organ sounds that are easily heard outside the body, e.g., coughing, wheezing, or the like, and other current technology captures reflected sound within the body, e.g., sonogram or ultrasound, these devices cannot provide the capturing of the organ sounds frequently throughout a period of time, as is possible with devices and methods of the present invention.
Traditionally a physician diagnoses the ailments of the body one organ at a time. As such biomarkers for a particular ailment tend to focus on one organ. Technology did not allow multiple organ biomarker relationships and those skilled in the art continue to think one organ at a time especially as the clinical process to accept new biomarkers is complicated.
Aspects of the present invention provide the opportunity to capture organ sounds from multiple organs, in proximity, at the same time. Someone skilled in the art would not consider this as not enough data exists at this time to promote this concept as a clinical practice. There are two major benefits to this. The first is that a patient does not have to facilitate collection of data one organ at a time. This reduces the burden on the patient and increases the utility for the physician. The second is that some organs are inter-related and where it was thought the onset of biomarkers may be in one obvious organ, it may present in another organ initially. Additionally, there presents the opportunity to identity sub ailments where one might be in the major organ only but other sub ailments may be better identified or classified due to secondary organ impacts.
One potential example might be the relationship between developing restrictions in the vascular system and the impact on the heart performance which ultimately results in multiple ailments-heart impairment due to strain, uncontrollable blood pressure and insufficient blood circulation in certain parts of the body. If the data collection is done in the torso area, then if there are developing restrictions that starts to emit, say, in an earlier form of a carotid bruit, then heart impact could be picked simultaneous such that the heart impact and carotid bruit could lead to a definitive diagnosis, as the carotid bruit on its own may not be always detectable or could be considered normal in some cases and the heart impact could be considered normal at first.
The scope of the invention is for continuous (many times in a daily period, set in the real world, whether it is during work, play, relaxation, sleep, or the like) auscultation-raw data collection at the least leading to event classification, at the mid-range, to ailment identification, at the highest end.
Devices can be applicable for organs of the torso area (lungs, heart, stomach, intestines, bowels, kidneys, liver, pancreas, gall bladder, vascular system, spine, or the like), larger joints (hips, knees, or the like), other parts of the vascular system not in the torso region, muscle masses, fat masses, any other region of the body that is sounded using a stethoscope. Aspects of the present invention may also be used for mother and fetal sounding.
The wearable 12 can take the form of various shapes or sizes.
Referring to
Referring now to
In some embodiments, the wearable 12 can include a data transmission module 56 for sending a signal to one or more external computing devices, such as a cloud computing device, a mobile device, a portable computer, a server, or the like, as discussed in greater detail below.
The sensors 42 in a sensor array can include one or more of the following: an accelerometer, a gyroscope, a microphone (where the microphone could be any of capacitive, piezoelectric, electro-magnetic, electret, and the like), temperature sensor (where the temperature sensor could be any of thermocouple, RTD, thermistor, infrared, and the like), vibration sensor, optical sensor (where the optical sensor can be configured for various applications), sensors for measuring blood oxygen saturation, sensors for measuring blood pressure, sensors for measuring skin impedance, sensors for measuring galvanic skin response and sensors for measuring the electrical potential of the body. Some or all sensors described above can be used according to the desired accuracy and depth of information.
In some embodiments, the array of sensors 42 capitalizes on processing by the pre-processor 44. Typically, the pre-processor 44 may be located on board the sensor 42 and/or sensor array. The extent of the pre-processing ranges from simple signal conditioning to pattern and event recognition.
Additionally, the sensor 42 and/or sensor array can include the ability to transfer data directly to memory (into the buffer/memory 46) for storage without engaging either the pre-processor 44 and/or the main processor 48.
Additionally, signals from the sensors 42 may be kept separate or be combined within the sensor array to form a fusion of sensor signals.
The pre-processors 44 can be of the low power variety. While the sensors 42 may not be classified as low power, they can be connected to dedicated low power pre-processors 44 for initial signal treatment.
In some embodiments, reduced power consumption can be achieved by having the sensor data be processed at dedicated low power pre-processors 44 at first and events of interest are then stored directly to memory 58 and/or the buffer/memory 46. After a period of time and/or memory count, the main processor 48 can come alive to process the sensor data that has passed the basic screening of the pre-processors 44. Typically, the period of time and/or memory count is sufficient to permit the main processor 48 to be, on average, in a sleep mode for a period of time greater than then amount of time it is operating. Typically, this data is unaltered sensor data from the sensors 42, but the amount of data is reduced by the basic screening algorithm pre-processing step performed by the pre-processors 44. The reasoning is that the main processor 48 uses the most power and therefore, should run for the least amount of time possible. The main processor 48 uses the most power because it operates the main functions of the wearable 12 and the processing algorithms, for example. The pre-processor 44 on a sensor only runs a basic screening algorithm and supports memory transfer thereby qualifying it as a low power application. In other embodiments, depending on the power demands of the wearable 12, the sensor data may be processed as it is received, or may simply be stored in the memory and transferred as raw data to a separate computing device for processing and/or analysis as discussed in greater detail below.
The wearable 12 can transmit data via a data transmission module 56 wirelessly according to a schedule. The next major power consuming component, a radio transmitter (part of the data transmission module 56), can be made into a low power component due to its very low duty cycle. While the transmitter operates to full design specifications, it does so for brief moments, resulting in reduced power consumption. By processing the signals onboard, the device derives a result and this result is simple to display, manipulate, transmit, and the like, as it is significantly less than having to output raw data streams. Hence the transmission of this brief result constitutes the extremely low duty cycle.
In some embodiments, as shown in
In some embodiments, the wearable 12 can continuously, in real-time, transmit pre-processed data to the remote computing device. While this mode may be more power consumptive, the power saved by not requiring use of the main processor 48 may offset the power needed for continuous use of the wireless radio.
The data transmission module 56 can transmit data in various methods, including Wi-Fi®, Bluetooth®, 4G, 5G, or the like. The wearable 12 may further include a port (not shown) to provide for wired communication to the remote computing device 70.
In some embodiments, the wearable 12 may provide, on-board, both the functions of the pre-processor and the main processor, as discussed above, where the wearable 12 can send the data from the main processor (which is typically the original data stream from the sensors, with data removed via both the pre-processing and the main processing algorithms) to the remote computing device for additional post-processing, where the remote computing device may use an even more robust algorithm for identifying or classifying the event of interest.
As used herein, the event of interest may be cough, a heart rhythm (or dis-arrythmia), wheezing, rales, or any other detectable cardio pulmonary event. The algorithm may be built into the wearable 12, where the wearable 12 is designed for detecting one or more particular events of interest. In other embodiments, the wearable 12 may be user-loaded with an algorithm, where the wearable 12 can be configured for the detection of a user-selected event of interest, depending on the particular algorithm(s) selected by the user from one or more of a plurality of user selected algorithms. These algorithms include both the basic screening algorithm (for use by the pre-processor), and the main algorithm, for use by the main processor, when present on the device, as discussed above. The user selected algorithms may be provided, for example, from a store or database of algorithms from which the user can select.
Additionally, the power management algorithm is able to shed functions as battery power runs low, thereby achieving a longer runtime on the remaining power. The methodology applied here to reduce power consumption extends beyond simply using low power components but rather governs the processes and architecture of the wearable 12.
Communication with external devices and environment for setup, information relaying, upgrades, and the like, can be done via a physical port (not shown, but may be, for example a micro and/or mini USB port), wirelessly via Bluetooth Low Energy, Bluetooth regular, Machine-to-machine (cellular based), Body Area Networks, ZigBee, and the like, and the method is determined by the application. Wireless communications may be direct to an end point or a relay unit and, as such, would incorporate the requisite antenna. One or more communication methods may be built-in to the wearable 12.
While the wearable 12 is intended to be worn against the body and while there is no substantial evidence to show that the above radio communication causes bodily harm, the wearable 12 may incorporate an added step to reduce exposure. Wireless infrastructure comes alive on a schedule that is user settable but ranging from once every fifteen minutes to once every two hours, for example. By having such a procedure, the body is exposed to radio signals emanating from the device only at those times. Further still, the length of the transmission during these times are estimated at no more than ninety seconds, for example, at design power.
The communication range of the wearable 12 depends on its operation. For setup and visualization of the output data, the wearable 12 can be connected to a smartphone or smartdevice via Bluetooth and or Bluetooth Low Energy architecture, for example. For setup and visualization of output data when a smartphone or smartdevice is not available or out of range, the device can connect via a cellular service to an end point, relay unit or data service. In this instance, the data can be re-routed to a smartphone or smartdevice and can also be available via a web portal.
Regardless of mode, the device can send alerts via all communication modes thereby increasing the range beyond Body Area Networks, Bluetooth and BTLE, node to node Wi-Fi, or the like.
The wearable is fully autonomous when compared with current devices in the market. The current thought is that processing is power hungry and so sensor data is transmitted in real time to another device for processing or uploaded periodically for processing. The wearable is then essentially tethered to another device to complete the analysis of the sensor data, rendering it simply as a data acquisition device. In this embodiment, the wearable 12 of the present invention is able to process the sensor data according to stored algorithms to arrive at a result and further still, investigate this result whether as an instance or with a set of prior results to render a decision inclusive of generating alerts.
This process works by having the having the sensor outputs coupled to fast low power processors, such as pre-processors 44, running qualification or filtering algorithms the eliminate sensor information that has less than 50% to 80% resemblance to sensor data that is of use. An algorithm capable qualifying the sensor data in this manner generally requires significantly less power to run as compared to an algorithm providing a response with less than 2% error. The selected data is stored immediately in equally fast memory, such as buffer/memory 46, where it is kept until the memory is full or a specified time has lapsed, whichever occurs first. At this moment, the main processor 48, running a very accurate algorithm, is called into operation to process the stored sensor data. Where information of interest occurs intermittently, this can result in only 10% to 30% of a period of time containing such information. Therefore, the main processor 48 operates less, saving power significantly. This forms the basis for an autonomous wearable operating for comparable times as those that are not but requires real time data transfer to another device.
Autonomy as implemented above is unique and positions the wearable 12 for use in many applications where audio events, motion events or combination audio and motion events are being monitored in real time. Interestingly, the very reason current real time monitoring products are tethered to another device, i.e., to save on power consumption, is the reason that full onboard processing is implemented resulting in autonomy, i.e., to save on power consumption.
The low power consumption results in the possibility to use smaller batteries; the distributed processing resulting in the need for less powerful processors; the use of new sensors in miniature packaging, recent advances in miniaturization, and the like, all play a role in the resultant physical properties of the wearable 12. The device is comparable in size and weight to other wearables in the market while these wearables are really just remote sensors, as explained above.
The small form factor plays a significant role in wearability as well as innovative approaches to manufacturing. The wearable 12 can utilize recent advancements in flexible circuit boards and flexible batteries. All three coupled together results in a wearable that could conform to the body's contours as it is in motion, resulting in less awareness of the wearable's presence. While current manufacturers are continuing development in hard housings, the wearable 12, according to embodiments of the present invention, is encapsulated in robust yet soft materials reducing the sensation of it against the skin. As shown in
Additionally, the wearable 12 can be designed to accommodate various adhesives being stuck to it for subsequent adhesion to the skin. The lightweight characteristics of the wearable 12 means that adhesives, such as adhesives 14, 18 of
As discussed above, the wearable 12 can include a main processor 48 or processors to control the operation thereof, execute the processing of signals, execute algorithms utilizing signal data and or stored data, execute power management, memory management, user interactions, wireless communications and any other processes and or functionality.
The processor 48 may be of the low power consumption variety and when it is such, the device has longer runtimes. Additionally, the processor 48 can be set to execute programs or applications on demand rather than having to execute an instruction set comprising most or all of the functionality.
Additionally, the programs or applications as well as the processor's operating system may be modified, changed or updated even after being set into operation. Such an approach allows for the device to be adopted for many uses as well as capitalize from automatic remote bug fixes and or functionality enhancement.
By processing the signals onboard, the wearable 12 derives a result that is simple to display, manipulate, transmit, and the like, as it is significantly less than having to output raw data streams. In other words, the main processor 48 and the communication module 56 may operate periodically. As used herein, a periodic operation of a component of the wearable 12 means that the component operates less than 50 percent of the time of use thereof, typically less than 25 percent of the time of use thereof, and usually less than 10 percent of the time of use thereof. For example, as discussed above, the wireless infrastructure can come alive on a schedule that is user settable but ranging from once every fifteen minutes to once every two hours, for example. Further still, the length of the transmission during these times are estimated at no more than ninety seconds, for example, at design power. This results in, for example, ninety seconds of data communication within a period of 15 minutes (where periodically here means 10 percent of the time) to 2 hours (where periodically here means 1.25% of the time).
Cough is an audible symptom and most manufacturers have adopted strictly audio based methods to identifying it. In the wearable 12 of the present invention, audio based cough recognition algorithms are utilized alongside motion associated with coughs. By combining the two, ambient coughs, i.e., coughs not originating from the user, are rejected as corresponding cough motions are not detected. While this seems logical, previous attempts at this were not fruitful as the wearable then required specific alignment for operation. With the wearable 12 of the present invention, sensor orientation is corrected for by other sensors like gyroscopes. Additionally, recent development into nine-degrees of freedom sensors now make is possible to accurately capture useful motion data which the wearable 12 can utilize.
The current cough devices are prone to false positives, require bulky computers for processing and some even require a human element to double check. The wearable 12 capitalizes on learning iterations that are a standard feature of audio event recognition algorithms to hone its skills in cough recognition.
In some embodiments, where onboard processing is not required, the sensor data may be preprocessed by the wearable 12 or may be sent directly to an external computing device for processing. In some embodiments, sensor data may be sent via the internet to a remote station for processing and the data may be stored in a database.
When the wearable 12 is being worn, it doubles over as an electronic stethoscope but more importantly, picks up sounds outside of human hearing which is important for recognizing patterns. The versatility of the algorithms means that the wearable 12 could be programmed to detect and record almost any acoustic physiological symptom or event that could be collected from the region of the upper torso.
The wearable 12 can be further equipped for detecting and recording heartbeat rate via audio and vibration methods. The wearable 12 can be further equipped for detecting and recording body skin temperature via any of thermocouples, thermistors, infrared, and the like. The wearable 12 can be further equipped with sensors for various other purposes, as described above.
While the above describes various embodiments of wearables usable in methods of the present invention, other wearables, as may be known in the art, may be incorporated in the methods of the present invention, as described below and in the accompanying claims.
In 5-15% of patients, an early acute pneumonitis, which is characterized by a non-productive cough, fever and dyspnea on exertion, develops 2-12 weeks after radiotherapy. It is thought that the early onset of symptoms is indicative of a more serious and protracted clinical course. In some cases, fibrosis spreads outside the radiation field, even to the contralateral lung, progressing to acute, often fatal, respiratory failure. Therefore, it would be very important if one were able to anticipate the occurrence of severe radiation pneumonitis (RP) spreading beyond the radiation field.
Referring now to
Metastatic lung cancer is a life-threatening condition that develops when cancer in another area of the body metastasizes, or spreads, to the lung. Cancer that develops at any primary site can form metastatic tumors. These tumors are capable of metastasizing to the lungs.
The symptoms of metastatic lung cancer can include a persistent cough, coughing up blood or bloody phlegm, chest pain, shortness of breath, wheezing, weakness and sudden weight loss.
Methods of the present invention may use wearable technology to monitor the already cancer-diagnosed patient to see if the cancer is metastasizing, in step 66, as evidenced by increases in some of certain parameters, such as those described in the above paragraph, monitored by the wearable.
Methods of the present invention that use wearable technology can also be used to monitor a patient, whether at risk for cancer or undiagnosed, to see if they are potentially developing cancer, in step 68, by identifying the parameter trends described above with respect to cancer metastasis, for example.
Physiotherapy, or physical therapy, is the treatment or management of a physical disability, malfunction, or pain by physical techniques, as exercise, massage, hydrotherapy, and the like.
Referring to
In some time of physiotherapy, e.g., breathing requirements, the monitoring of someone prior to (step 76), during (step 78) and after (step 79) therapy may be useful to see if they are in need of therapy, how they are responding to therapy, and how they are progressing once therapy is concluded, respectively.
Some individuals may not be able to properly express themselves to let others know if they are developing or experiencing distress. For example, autistic persons may lack the ability to verbally express themselves. Intellectual disability is defined as mental retardation or impairment in the areas of development or cognitive activities. Intellectual disability may be defined as a disability characterized by significant limitations both in intellectual functioning and in adaptive behavior, which covers many everyday social and practical skills. This disability originates before the age of 18. Because of intellectual disabilities many people are not able to express their pain verbally. Therefore, the skills of nursing staff are important to identify and manage pain in this vulnerable group of people. Pain assessment and management have been the focus of interest internationally in several scientific fields. However, research into pain assessment among non-communicating intellectually disabled people has been very limited.
Referring to
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Safety devices are used by public safety personnel, such as by firefighters, to detect, for example, lack of movement. Firefighters currently often wear a device on their person that will sound an alert if the person is not moving for a certain period of time. However, by the point of non-movement, a firefighter may already be physiologically distressed to a point of damage.
Referring to
Referring to
For example, an increase in activity level, and possibly respiration and heartbeat rate, could signal the need for more gas volume due to potential increase in depend (e.g., for oxygen). This allows the amount of gas made available to suit demand, thereby possibly reducing waste or complications with excessive or insufficient or inappropriate mixtures and the like.
This application could be extended into monitoring during some surgeries for more effective application of anesthesia gases in step 116, e.g., procedures at underequipped facilities, such as for cosmetic surgery.
This application may also be used for other applications where gas mixtures and/or appropriate oxygen delivery is required. For example, scuba divers may be monitored to measure blood gases and adjust breathing gas mixtures accordingly, thereby assuring proper mixtures for deep dives, long dives and the like. Further, babies in distress may need supplemental oxygen, however too much oxygen could result in brain injury or blindness. Therefore, methods of the present invention can measure parameters, such as an infant's respiration, heart rate, blood oxygen saturation, and the like, to adjust the amount of supplemental oxygen provided.
Referring to
Along these lines, methods of the present invention not only include monitoring a patient or user to identify increases in symptom levels where lower levels are preferred, but also for decreases in levels where elevated levels are preferred. For example, coughing is often encouraged after some treatment types or for some illnesses. The methods of the present invention, in step 128, can monitor the patient to be assure that these activities are being performed and/or such values being measured.
Methods of the present invention can use wearable technology for various respiratory illnesses in identifying symptom levels, early onset of symptoms before the wearer is aware, in step 129, providing alerts based on set points and/or baselines, and the like. These illnesses can include other non-respiratory illnesses, including those illnesses that result in a change that can be identified by changes in the measured parameters of the wearable.
Referring to
Referring now to
Certain methods of the present invention may be used by a clinical research organization for testing the effects of a drug or other treatment. Clinical trial centers may use wearable technology within aspects of the present invention, to measure various physiological parameters associated with the drug and/or placebo to better understand and report drug effects.
Methods of the present invention can allow for customization to a particular study to suit the type of information being collected. For example, respiration data can be monitored continuously or in response to changes to another parameter. Provisions may be made for those conducting the research to provide feedback to the user either electronically (e.g., use of algorithms) or from remote terminals, via the wearable.
Methods of the present invention can use wearable technology for monitoring athletes and other persons participating in a sport. Monitoring may be made during rest, training, competition and post competition. This establishes a baseline and helps the user to begin getting feedback from the device when they are tending to body parameters level that are counter to a good game. For example, methods of the present invention could be used to identify if breathing affects performance. An athlete could discover, for example, that deep breaths during non-exertion during a competition enhances ability and skill level. The athlete could use this data to their advantage to improve their abilities. In some embodiments, the data collected may be time tracked so that the user can, for example, play a video of their performance in the athletic event while watching, in real time, their physiological parameters monitored by the wearable device.
In some embodiments, the methods of the present invention can use wearable technology to detect possible distress in an athlete, alerting the athlete or a coach to rest the athlete, or, in severe cases, get medical attention. In some events, especially at the high school or college level, an athlete may desire not to show signs of stress or fatigue, but instead, continue play, perhaps to the detriment to their overall health. Methods of the present invention allow coaches to detect such stress or fatigue and react accordingly.
Leagues and other sporting bodies need to begin providing additional content about the sport in order to engage the viewer and thus result in better broadcast revenue. As the sports are not changing, this additional information is tending towards anything possible about the player as well as simulations of outcome.
For example, for timed sports, the viewer can see accurate timing for the participants at various stages of the event. For example, bobsled runs may provide time checks at various points and show the user how far away the current runners are from the leader. This helps engage the viewer and adds to the overall excitement of the finish. Another use of technology used to help viewers is how in recent years, during football games, the line of scrimmage and the first down line may be marked on the field for the viewer to see.
However, as viewers become more accustomed to a particular feature or technology being used, their added excitement for viewing the sport may decline. Methods of the present invention can use wearable technology to monitor a player and provide real time data on body function that results in additional content that could generate revenue. This information could simply be displayed to the viewer or may be fed to relevant bodies to fuel betting on certain aspects, thus generating additional revenue.
For example, a user could bet that a particular basketball player would score all their points while keeping their pulse below a certain value, or the user could bet that one coach would keep their blood pressure below the other coach throughout the entire game.
Embodiments of the present invention could be used in non-physical sporting events or competitions, such as mental sporting events (chess, poker) or virtual reality or software-based gaming. For example, physiological parameters for poker players could be monitored and displayed to viewers to provide a further dimension to their play. The players themselves could later review this information to help keep their “poker face” and lessen certain tells they may be giving to other players.
Referring now to
Once disposed on the user, the wearable is activated and physiological data is collected by one or more sensors in step 154. The data may be collected, in some embodiments, during participation in a sporting event. The data may also be collected before the sporting event, or after the event, depending on the method. Of course, the data may be collected based on other aspects of the present invention as described above.
The output of the wearable device may be provided to a viewer in step 156. The output may be raw data sent by the wearable or may be data pre-processed or processed by the wearable. The output can be further processed by a computing device on which the viewer views the data. The computing device may provide the data in user-friendly form. For example, the data may be of a particular athlete in a sporting event and may be provided adjacent to the athlete's name or photo on the computing device.
In some embodiments, should the data be abnormal for the user's particular activity, the computing device and/or the wearable itself may generate an alert in step 157. This alert may provide a viewer of the data of a baseline value and the current, real time value of this parameter from the user, for example. For example, a football player whose pulse pressure is widening may be a result of dangerous inter-cranial pressure due to a head injury. Such detail could be alerted to the appropriate personnel to have the person removed from the game and examined before the condition worsens.
In some embodiments, the data can be displayed to a viewer of a sporting event, for example, on a television display, in step 158. This data may be continuously displayed or displayed at intervals to show on or more physiological measurements taken of the athlete, for example. In some embodiments, a user may be permitted to bet on the sporting event, at least in part based on the physiological measurement taken by the wearable in step 159. The display of physiological parameters and the ability to bet on such parameters adds new dimensions to sports broadcasting and the user viewing experience.
Referring to
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Next, in step 176, during a telemedicine call, the healthcare provider can instantly access body function and physiological data that may exceed what would normally be collected during a typical office visit, thus enhancing the ability to diagnose. Third, in step 178, if the wearer continues to wear the device after a call, the healthcare provider can get follow-up information that can drive the effectiveness of the course of action prescribed.
Furthermore, methods of the present invention provide a telemedicine service that offers patient monitoring, in step 179, and can actually identify the possibility of a condition before the potential patient is aware. This service may use the wearable to collect data and send such data to a database periodically. This data is analyzed for abnormalities from baseline data. Such abnormalities may be screened against a database for possible diagnosis, or may be sent to a healthcare provider for additional follow-up. For example, the wearable device may receive data to indicate that the wearer is developing a fever, has a cough with little mucus and has shortness of breath. The device itself, via internal algorithms, or a separate computing device receiving data from the wearable, can notice these symptoms deviate from the user's baseline. This information may be sent to a healthcare provider and the user may be alerted they have non-bacterial pneumonia before they even realize they are becoming sick.
Referring to
At the time of discharge from a hospital, the user can be provided, in step 184, with a wearable device to wear and continue to send information back for monitoring. This allows the hospital to identify possible relapse or other conditions which may mean that the patient would have to return to continue treatment or seek a new diagnosis.
In some embodiments, a wearable device can be provided to a patient, in step 186, for use during the period of time when they initially made an appointment to the time of the appointment, or any portion of this timeframe. This allows the healthcare provider to be aware of symptoms in detail at the time of the visit or even to prepare feedback in preparation of the visit.
In some embodiments, wearable technology can be used, in step 188, as an aid for wards which allow patients with non-life threatening conditions to continue to be monitored at a lower cost and in real time. The device could be programmed to sound an alert to indicate if an immobile person needs to be turned, or the like. In some embodiments, the device could be programmed to ask the patient to perform a certain task, such as to cough, where the device can record the cough's characteristics for later analysis.
Referring to
Additionally, embodiments of the present invention can provide, in step 196, methods for using a wearable device on at risk prisoners who may have illnesses that need closer monitoring. In such cases, where it is not practical to have daily medical checkups, these methods can provide the relevant feedback.
Finally, methods of the present invention, in step 198, can use wearable devices on prisoners or detainees to monitor certain physiological parameters to not only detect the state of health of such persons, but also to detect any state of agitation. Such may be useful for correction officers to detect a potential problem, such as a prisoner fight, before it happens or at least before it can escalate and provide the appropriate response.
Referring to
The wearable 12 can be used in various applications. One such application is the detection of an asthmatic attack prior to its occurrence. Conventionally, asthma monitoring was focused on symptoms evident during an attack and not prior to it; acoustic monitoring for health solutions are focused on replicating the performance of a stethoscope; detached sensors are prone to picking up ambient noises to the extent that target signals are obscured; some physiological symptoms require multiple sensor types to simultaneously record various components of the symptoms to confirm the symptom. The wearable 12 addresses these pitfalls of conventional devices.
Traditionally, the symptoms monitored to indicate an asthmatic attack, whether self-monitoring or with the aid of a device, have always been those associated with an on-going attack. The primary reason being that they were the easiest to spot and they required the simplest technology when needed. For example, an attack is determined by a self-monitoring method of identifying wheezing or determined by a device monitoring method of identifying lung function changes via a spirometer. These classic symptoms were chosen to match the availability of technology or case to understand, but they are all symptoms of an ongoing attack which is more of a reactive approach.
Embodiments of the present invention focus on symptoms that manifest at the onset of an attack which is typically well before the traditional symptoms found during the attack—an asthmatic attack builds up over time. The approach is proactive as compared to the traditional reactive methods. Knowing the indicators earlier enables remedial action before the situation is exacerbated. These symptoms, while well known, were difficult to identify and monitor without the use an extensive array of equipment in constant attendance. The wearable 12 of the present invention has miniaturized the equipment set facilitating constant use in a non-invasive manner.
The stethoscope is unsurpassed when it comes to listening to the human body because it is in direct contact with the body and the sounds are amplified and transmitted directly to the listener. In essence, the listener hears practically the entire audible spectrum without any significant loss. The stethoscope is key for a physician to pick up and determine the severity of Asthma related symptoms. The problem with us utilizing an existing digital stethoscope is that we would require sophisticated pick up microphones, full spectrum amplifiers and digital signal processing capability for high quality signals—these features are required to emulate a simple stethoscope. For Asthma symptom monitoring, one does not need full spectrum microphones and signal processing-just for the frequency range that is required. Embodiments of the present invention remove excess capability that results in reduction in size, process requirements, power consumption—in essence, it results in an ultra-portable stethoscope optimized for audible Asthma symptoms. Without this, the wearable 12 may have problems with size, power consumption, relevance, cost, and the like.
Current methods in the market to sense and measure the symptoms associated with asthma are prone to picking up and measuring excessive and false data. For example, built-in microphones from smart phones or other devices pick up ambient noises even if they are worn in clothing pockets or secured with bands. Likewise, microphones in earpieces also do the same. Accelerometers from the smart devices worn in pockets, strapped on with bands, or the like, all pickup additional motion, introducing errors. Accelerometers in devices secured to the hand pick up even more extraneous data. Non-contact sensors reduce the ability for complete mobility unless the non-contact sensor unit accompanies the user, which is impractical.
The wearable 12 of the present invention can position the sensors and secure them in the optimum positions so that extraneous, ambient and false readings are reduced significantly. Further still, by being firmly attached to the user, the range of signals are limited to those possible from the human body, for the most part. The wearable therefore solves the problem of having false and nuisance signals as well as facilitates the pick-up of symptoms where a physician will look for them.
The available devices on the market that could have been used with some modifications, i.e., the addition of missing sensors, are limited in their architecture when it comes to picking up human body symptoms. Most symptoms are composed of multiple parameters, e.g., breathing involves motion, sound and vibration, or say coughing which involves sound, motion and vibration. To pick these symptoms up, the use of signals from more than one type of sensors is required and these signals must be in time with each other. Similarly, the processing to identify the symptom must be done on each signal and the processing is generally different for each signal. Available devices are unable to achieve this in an efficient manner that supports implementation as a wearable.
The wearable 12 of the present invention can include various sensors built-in in the first instance and they are all picked up, sampled, measured, stored and processed so that the integrity of them are preserved to arrive at the conclusion that the symptom is picked up and identified.
While the above description of the wearable 12 targets respiratory diseases, the wearable 12 of the present invention can be used for cardiology, fitness, and other health/biometric requirement for humans, livestock and other animals. Additionally, the device could be used for any application that recognizes a particular sound, e.g., gunshot monitoring in cities, chain saws in forests, mining activities, gunshot monitoring in reserves and parks, monitoring arrival of migratory animals, SIDS research, and the like.
While the intended application is a wearable, from the above, it could be packaged for outdoor mounting in all weather conditions as well as for indoor mounting.
While the above description describes cough as an event of interest related to respiratory diseases, the event of interest for the device to detect can include other heart or lung sounds, such as wheezing, rales, or the like.
While the above description describes an on-body monitoring device that can make continuous measurements for a plurality of days, in some embodiments, the device may be used both for on-body monitoring and instance monitoring. In this embodiment, lung sounds may be captured by the on-body functioning of the device, as discussed above. However, when the user does not want to or cannot wear the device on-body on a given day, the user can perform one or more spot readings. Such spot readings may be obtained, for example, by the user breathing onto the device so it can capture spot info. During these days, one or more spot readings would provide at least some data, an improvement on getting no readings over a particular time period. The wearable could pick up the data if the user blows or breathes on it or adjacent to it, for example.
Referring to
While the above description provides several different methods for using wearable devices, including some specific examples, it should be understood that the present invention is not limited to such specific examples. Moreover, while the above describes wearables that attach directly to the skin, other wearables, such as garment implemented wearables, may be used in certain embodiments of the present invention.
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiments have been set forth only for the purposes of examples and that they should not be taken as limiting the invention as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different ones of the disclosed elements.
The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification the generic structure, material or acts of which they represent a single species.
The definitions of the words or elements of the following claims are, therefore, defined in this specification to not only include the combination of elements which are literally set forth. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination.
Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.
The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted and also what incorporates the essential idea of the invention.
This application is a continuation-in-part of U.S. patent application Ser. No. 18/296,045, filed Feb. 14, 2022, which is a continuation of U.S. patent application Ser. No. 15/431,531, filed Feb. 13, 2017, now U.S. Pat. No. 11,622,716, the contents of each of which are herein incorporated by reference. This application also is a continuation-in-part of U.S. patent application Ser. No. 17/650,958, filed Feb. 14, 2022, which is a continuation-in-part of U.S. patent application Ser. No. 15/147,293, filed May 5, 2016, now U.S. Pat. No. 11,272,864, which claims the benefit of priority from U.S. provisional patent application No. 62/218,109, filed Sep. 14, 2015, the contents of each of which are herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62218109 | Sep 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15431531 | Feb 2017 | US |
| Child | 18296045 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18296045 | Apr 2023 | US |
| Child | 18764769 | US | |
| Parent | 17650958 | Feb 2022 | US |
| Child | 18764769 | US | |
| Parent | 15147293 | May 2016 | US |
| Child | 17650958 | US |
