Patent Application
20180103858
The present invention relates generally to electrocardiogram (ECG) monitoring and, more particularly, to wearable devices with integrated ECG sensors for ambulatory ECG monitoring, and related systems and methods.
Heart disease is a leading cause of death in the United States. Some patients may benefit from long-term ECG monitoring outside of a clinical setting. For example, atrial fibrillation and myocardial ischemia may occur episodically. Some episodes may occur without patient symptoms. Myocardial ischemia, if persistent and serious, can lead to a myocardial infarction (heart attack). During a myocardial infarction, electrophysiological changes may be detected by an ECG. For accurate diagnosis and effective treatment of many episodic heart conditions, medical professionals need to receive accurate and timely information regarding the frequency and duration of such episodes.
In conventional long-term ECG monitoring, such as with continuous Holter monitors or event monitors, mounting of the monitor typically involves preparation of the patient's skin to receive the monitoring device. Chest hair may be shaved or clipped from men. The skin is abraded to remove dead skin cells, and cleaned. A technician trained in electrode placement applies the electrodes to the skin with an adhesive. Each electrode of such conventional monitors is attached to an insulated wire that is routed some distance across the patient's body to an amplifier designed to amplify the ECG signal in preparation for further processing. Such monitoring systems are often worn by a patient for up to a month.
Traditional long-term monitoring systems like those described above present a number of problems. For example, abrading in preparation for electrode mounting often leaves the patient's skin irritated. During use, the patient must be careful not to pull on the wires connected to the electrodes, lest the electrodes be pulled off the skin. Removing an electrode with its strong adhesive may be painful to the patient. Furthermore, certain types of electrodes require use of a gel next to the skin to improve conductivity at the point of connection of the metal electrode to the skin. Prolonged exposure to the gel can irritate the skin. These and other discomfort factors associated with traditional long-term monitoring solutions may discourage a patient from using the ECG monitor as directed by medical personnel.
Alternative health monitoring system designs exist that attempt to address the many shortcomings of traditional ECG monitors. For example, some monitor implementations known in the art are based on an article of apparel designed to be conveniently and comfortably worn by the patient, such as a wrist band or earbud. However, the still-prominent profile of such monitors still may cause wear, and use of such devices can be uncomfortable and error-prone. Also for example, some monitors are implemented as earphones equipped with sensors and data communications means, such as the following.
U.S. Pat. No. 7,769,435 to Kuo et al. discloses an earphone sensor system for measuring electrocardiogram signals. The electrocardiogram signal analyzing apparatus includes an amplifier module, a microcontroller, a display, a radio module and a housing having conductive contacts. The earphone sensor system can be associated with commercial gadgets and used for musical treatments and bio-feedback.
W.O. Patent Application No. 2009069037 by Powers discloses a heart monitor including an electroacoustic transducer such as an earphone coupled to a controller. The transducer is positioned in a person's ear such that signals from the transducer are processed to determine the presence of pulsatile blood flow. The heart monitor may be incorporated into a portable media playback device alternating between playback and monitoring mode or performing both simultaneously using one earphone for each function.
U.S. Patent Application No. 2013/0158423 by Kapoor is directed to a system for acquiring an electrical footprint of the heart, electrocardiogram (ECG) and heart rate variability monitoring, incorporated into a mobile device accessory. The ECG signal is acquired and transmitted to a server via the mobile device, offering accurate heart rate variability biofeedback measurement which is portable and comfortable during normal daily life.
The implementations described above, as well as similar devices, systems, and methods known in the art, may require some special modification to a smartphone or other mobile device for proper function, are limited to one channel, and/or require data transmission to an external server for signal analysis. Consequently, a need exists for increasingly comfortable and convenient monitoring devices for both personal and medical use, and that overcome the shortcomings of common implementations in the field.
While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, the applicant in no way disclaims these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein. The present invention may address one or more of the problems and deficiencies of the current availability and prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein, or limited to the particular embodiment for the invention used to illustrate the steps and functionality of the herein.
This background information is provided to reveal information believed by the applicant to be of possible relevance to the present invention. No admission is necessarily intended, nor should be construed, that any of the preceding information constitutes prior art against the present invention. This reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.
With the foregoing in mind, embodiments of the present invention are related to systems and methods for monitoring a health status of a patient using a monitoring system. More specifically, the present invention may include a processor, an electrical signal conversion unit, and a pair of earbud electrocardiogram (ECG) monitors each including a respective conductive electrode component. The electrical signal conversion unit may carry a third electrode. Each conductive electrode component and the third electrode may comprise a physiological-type sensor.
A method aspect of the present invention may include the steps of positioning each of the conductive electrode components of the earbud ECG monitors in a respective ear of the patient, and receiving biopotential signals from each ear of the patient. The method further may include receiving, using the third electrode, biopotential signals from one of a left arm and a hip of the patient. Triggering of biopotential signal readings from all sensors may be by virtue of a record button carried by the electrical signal conversion unit.
Another method aspect of the present invention may include the steps of converting, using the electrical signal conversion unit, one or more of the biopotential signals described above into converted ECG data. The method further may include forwarding the converted ECG data to a smartphone, and analyzing the converted ECG data for cardiovascular health indicators using some number of smartphone applications. The earbud ECG monitors may advantageously cooperate with the electrical signal conversion unit to convert audio signals transmitted by the smartphone into sound using speaker units carried by the earbud ECG monitor.
More specifically, the electrical signal conversion unit may include a system on a chip (SoC) having a data store and a processor. The processor may retrieve processing functions from the data store and may execute those processing functions to identify the health status of the patient from the biopotential signals described above. The SoC may be configured in data communication, either wired or wirelessly, with the smartphone.
The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Those of ordinary skill in the art realize that the following descriptions of the embodiments of the present invention are illustrative and are not intended to be limiting in any way. Other embodiments of the present invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Like numbers refer to like elements throughout.
Although the following detailed description contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the invention.
In this detailed description of the present invention, a person skilled in the art should note that directional terms, such as “above,” “below,” “upper,” “lower,” and other like terms are used for the convenience of the reader in reference to the drawings. Also, a person skilled in the art should notice this description may contain other terminology to convey position, orientation, and direction without departing from the principles of the present invention.
Furthermore, in this detailed description, a person skilled in the art should note that quantitative qualifying terms such as “generally,” “substantially,” “mostly,” and other terms are used, in general, to mean that the referred to object, characteristic, or quality constitutes a majority of the subject of the reference. The meaning of any of these terms is dependent upon the context within which it is used, and the meaning may be expressly modified.
Throughout this disclosure, the present invention may be referred to as an earbud ECG system, an earbud system, an ECG monitor system, an ECG system, a heartrate monitor system, an earbud heartrate monitor, an earbud, a monitor, a computer program product, a computer program, a product, a system, a device, and a method. Furthermore, the present invention may be referred to as relating to generally to biometric monitoring. Those skilled in the art will appreciate that this terminology does not affect the scope of the invention.
Example methods and systems for an earbud ECG monitor system are described herein below. In the following description, for purposes of explanation, numerous specific details are set forth to provide a thorough understanding of example embodiments. It will be evident, however, to one of ordinary skill in the art that the present invention may be practiced without these specific details and/or with different combinations of the details than are given here. Thus, specific embodiments are given for the purpose of simplified explanation and not limitation.
An embodiment of the invention, as shown and described by the various figures and accompanying text, provides an earbud electrocardiogram (ECG) monitor system 100 comprising some number of electrode-employing components 102 configured in electrical communication with an electrical signal conversion unit 104 which, in turn, may be configured in data communication with a processor 170 (as illustrated in
The related systems and methods of using the disclosed earbud ECG monitor 100 may advantageously leverage user skills that may be common among many individuals (e.g. devices carried in armbands in order to play music during exercise). These disclosed devices, systems, and methods may advantageously allow for the addition of ECG monitoring functionality without a significant increase in hardware requirements. Also, the disclosed system 100 advantageously may not require modification of the user's smartphone 170 (nor the purchase of a new smartphone), may allow for a consistently reliable hard-wired connection (e.g., may minimize connection failures common to wireless capability, as well as minimizing signal noise), and may maintain audio playback while offering comfort and efficiency in ECG measurement. For example, and without limitation, the present invention may be applied in the fields of cardiovascular medicine and health, sports medicine, and therapy in the area of ambulatory ECG monitoring. More specifically, the present invention may appeal to the fitness-oriented consumer and may also be applied to ECG-related procedures to drive patient compliance.
Referring now to
In one embodiment, the electrode/sensor component 110 may comprise a material that is both an excellent conductor and that may also be efficient in maintaining the earbud's 102 position within the concha of a human ear. For example, and without limitation, such materials may include electrically conductive silicone, which may easily be molded into a variety of shapes and which may allow for efficient design to increase signal quality. Also for example, and without limitation, the earbud 102 may be characterized by a rubber (or similar material) wire seal/guard 118 that may be positioned at the distal end of the earbud stem 114 to further protect the wiring 118 and to prevent damage due to moisture leakage on the inside of the device casing 112.
Referring now additionally to
In yet another embodiment of the present invention, the system 100 that uses the earbud ECG monitor 102 described above may also comprise an input apparatus alternative to the proposed modified earphones that may include a similar (if not same) conversion unit, wherein the earbuds may be replaced with regular ECG skin electrodes at the terminal end of the cable. These electrodes may be placed on the user's chest in an arrangement conducive to collecting viable ECG signal data. For example, and without limitation, the alternate system may include electrodes that may be able to support any desired number of leads.
Referring now additionally to
Referring again to
Referring now additionally to
The overall function and order of systemic events, as illustrated in schematic 160, according to certain embodiments of the present invention, may be summarized as follows:
1) From the start (Block 505), a detected input signal (Block 515) may be harvested (Block 520) either from the two earbuds solely, from the electrodes 110, from the earbuds 102 and backside of conversion unit casing 143, or from any other viable combination of conductive components.
2) The signal may be relayed to the conversion unit 104 through the earbud/electrode cable 119, 130, where the signal may be processed and converted into a readable format of microphone data (Block 530), similar to existing TTM function, for example, and without limitation.
3) The newly converted ECG-Mic data may then be sent from the conversion unit 104 to the smartphone 170 through the cable 149 and/or the TRRS-type manufacturer-compatible headphone jack 120.
4) The ECG-Mic data may then be read by the smartphone 170/mobile device (either directly by the intended application, or by the phone itself and then pulled into the application). With the aforementioned electrode configuration (each ear, and then either left arm or hip), there may be two available channels of ECG data with the 3-lead setup.
5) At Block 540, analysis, transmission, or other subsequent processing of the ECG data may then be performed by the application and smartphone 170.
6) At Block 565, user and/or system input may dictate whether ECG signal harvesting and processing is complete. If so, the process may end at Block 599. If not, the process may seek to detect additional ECG signal input (Block 515).
Referring now to
As related above, the electrical conductor 110 may be in data communication with the data store 240, which may retain recorded signals until transmitted (transient) and/or may retain recorded signals until either manually or automatically deleted (persistent). The transmitter 260 may be configured to receive data from at least one of the conductor 110 and the data store 240, and to communicate the data representing electrical signals detected by the conductor 110. Also for example, and without limitation, the SoC 200 may comprise a receiver 270 in electrical communication with the data store 240. The receiver 270 may be configured to receive data and route those data to the data store 240 through the processor 250. For example, and without limitation, both communication of data from the transmitter 260 and receipt of data by the receiver 270 may occur wirelessly or over telephone lines. In one embodiment of wireless communication, the transmitter 260 and/or the receiver 270 may be implemented using radio frequency identification (RFID) technology. In other embodiments, the transmitter 260 and the receiver 270 may be provided in combination by a transceiver.
Continuing to refer to
A skilled artisan will note that one or more of the aspects of the present invention may be performed on a computing device. The skilled artisan will also note that a computing device may be understood to be any device having a processor, memory unit, input, and output. This may include, but is not intended to be limited to, cellular phones, smart phones, tablet computers, laptop computers, desktop computers, personal digital assistants, etc.
The computer 610 may also include a cryptographic unit 625. Briefly, the cryptographic unit 625 has a calculation function that may be used to verify digital signatures, calculate hashes, digitally sign hash values, and encrypt or decrypt data. The cryptographic unit 625 may also have a protected memory for storing keys and other secret data. In other embodiments, the functions of the cryptographic unit may be instantiated in software and run via the operating system.
A computer 610 typically includes a variety of computer readable media. Computer readable media can be any available media that can be accessed by a computer 610 and includes both volatile and nonvolatile media, removable and non-removable media. By way of example, and not limitation, computer readable media may include computer storage media and communication media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, FLASH memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a computer 610. Communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media. The term “modulated data signal” means a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. By way of example, and not limitation, communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, radio frequency, infrared and other wireless media. Combinations of any of the above should also be included within the scope of computer readable media.
The system memory 630 includes computer storage media in the form of volatile and/or nonvolatile memory such as read only memory (ROM) 631 and random access memory (RAM) 632. A basic input/output system 633 (BIOS), containing the basic routines that help to transfer information between elements within computer 610, such as during start-up, is typically stored in ROM 631. RAM 632 typically contains data and/or program modules that are immediately accessible to and/or presently being operated on by processing unit 620. By way of example, and not limitation,
The computer 610 may also include other removable/non-removable, volatile/nonvolatile computer storage media. By way of example only,
The drives, and their associated computer storage media discussed above and illustrated in
The computer 610 may operate in a networked environment using logical connections to one or more remote computers, such as a remote computer 680. The remote computer 680 may be a personal computer, a server, a router, a network PC, a peer device or other common network node, and typically includes many or all of the elements described above relative to the computer 610, although only a memory storage device 681 has been illustrated in
When used in a LAN networking environment, the computer 610 is connected to the LAN 671 through a network interface or adapter 670. When used in a WAN networking environment, the computer 610 typically includes a modem 672 or other means for establishing communications over the WAN 673, such as the Internet. The modem 672, which may be internal or external, may be connected to the system bus 621 via the user input interface 660, or other appropriate mechanism. In a networked environment, program modules depicted relative to the computer 610, or portions thereof, may be stored in the remote memory storage device. By way of example, and not limitation,
The communications connections 670 and 672 allow the device to communicate with other devices. The communications connections 670 and 672 are an example of communication media. The communication media typically embodies computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism and includes any information delivery media. A “modulated data signal” may be a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. By way of example, and not limitation, communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, RF, infrared and other wireless media. Computer readable media may include both storage media and communication media.
Some of the illustrative aspects of the present invention may be advantageous in solving the problems herein described and other problems not discussed which are discoverable by a skilled artisan.
While the above description contains much specificity, these should not be construed as limitations on the scope of any embodiment, but as exemplifications of the presented embodiments thereof. Many other ramifications and variations are possible within the teachings of the various embodiments. While the invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best or only mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims. Also, in the drawings and the description, there have been disclosed exemplary embodiments of the invention and, although specific terms may have been employed, they are unless otherwise stated used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention therefore not being so limited. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another. Furthermore, the use of the terms a, an, etc. do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item.
Thus the scope of the invention should be determined by the appended claims and their legal equivalents, and not by the examples given.
This application claims the benefit under 35 U.S.C. § 119(a)-(d) of International Publication Number WO 2016/145438 filed on Mar. 14, 2016 and titled Earbud Electrocardiogram Monitor and Associated Systems and Methods, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 62/132,221 filed by the inventor of the present application on Mar. 12, 2015, and titled Earbud Electrocardiogram Monitor and Associated Systems and Methods, the entire content of which is incorporated herein by reference except to the extent that disclosure therein is inconsistent with disclosure herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US16/22311 | 3/14/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62132221 | Mar 2015 | US |
