Abstract:
A wallet-card sized, flexible, largely self-contained electrocardiogram (EKG) device able to wirelessly communicate EKG data to a smart phone, or similarly functional device, hosting an application that can receive and display the EKG data, as well as do some analysis to identify particular heart conditions and display that information, or data product. The EKG device processes data from its integral electrodes into EKG data, can store up to an hour of data, and can wirelessly transmit the EKG data from storage or from real-time processing. The smart phone receives the EKG data, makes it available to the application, and displays results produced by the application, which may include alarms or identification of specific heart problems. The smart phone can further communicate the EKG data and additional data products to a web server application, which can perform additional analysis for display, or communicate to a medical provider.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. provisional patent application Ser. No. 61/604,128 filed Feb. 28, 2012 naming the same inventor. 
     
    
     TECHNICAL FIELD 
       [0002]    This invention relates to EKG devices for providing electrocardiography. More particularly, it relates to wireless, portable, flexible EKG devices that are about the size of a credit card. 
       BACKGROUND 
       [0003]    EKG devices provide information about electrical activity in the thorax, which provides medical information about the heart. EKG devices are used, for instance, for diagnosing heart attacks. Some EKG devices are bulky and have up to twelve electrical leads that must be attached to the patient which requires a significant amount of time, even when little time is available. Much of the bulk is associated with recording and printing of the electrocardiogram for visual analysis by a specialist. 
         [0004]    Therefore, a need exists for small portable EKG device that can be quickly attached to the patient and can rapidly provide information about the patient&#39;s heart. 
       OBJECTS AND FEATURES OF THE INVENTION 
       [0005]    A primary object and feature of the present invention is to overcome the above-mentioned problems and fulfill the above-mentioned needs. 
         [0006]    Another object and feature of the present invention is to provide an EKG device that is about the size of a credit card. Another object and feature of the present invention is to provide an EKG device that wirelessly transmits data to a computer or smart phone for display and analysis. Another object and feature of the present invention is to provide an EKG device that is disposable. Another object and feature of the present invention is to provide an EKG device that can be quickly connected to the patient. Another object and feature of the present invention is to provide an EKG device that sends data to a computer application that can analyze the data and provide alarms for particular heart conditions. Another object and feature of the present invention is to provide an EKG application for computer or smart phone that can contact the patient&#39;s doctor and relay the electrocardiogram to that doctor. Another object and feature of the present invention is to provide an EKG application for computer or smart phone that can relay the electrocardiogram produced by the EKG device to a website for further analysis. It is a further object and feature of the present invention to provide an EKG device that can be reconditioned and re-used. It is a further object and feature of the present invention to provide an EKG device that can store up to an hour of data. Another object and feature of the present invention is to provide an EKG device that can adhere to the patient&#39;s chest. 
         [0007]    It is an additional primary object and feature of the present invention to provide such a system that is efficient, inexpensive and handy. Other objects and features of this invention will become apparent with reference to the following descriptions. 
       SUMMARY OF THE INVENTION 
       [0008]    In accordance with a preferred embodiment hereof, this invention provides a small wireless portable EKG device and a computer application, which may be a smart phone application, together comprising the EKG system. The EKG device is a credit-card sized (or smaller) device with an adhesive backing, covered by a release layer until used, at least two conductive electrodes communicatively coupled to a signal processor which processes the raw data into an electrocardiogram. The signal processor is communicatively coupled to a processor memory, where the electrocardiogram data may be stored. The processor memory and the signal processor are communicatively coupled to a wireless transceiver which, in turn, is communicatively and wirelessly coupled, during at least a portion of operation, to a computer, smart phone, or the like. The computer hosts an application for at least receiving and displaying the electrocardiogram, and optionally for contacting a cardiologist, sending the data to another computer for further analysis, or further analyzing the data in the application. 
         [0009]    The present invention provides a small wireless portable electrocardiogram (EKG) system including; a small, flexible, wireless, and portable EKG device; and a first computer application able to receive wireless data originally sent from the EKG device and to provide for display at least one of the data and at least one data product. The system, where the EKG device is either a flexible panel no larger than two inches wide by three inches long by fifteen hundredths of an inch thick or a flexible panel no more than two inches wide and fifteen hundredths of an inch thick and having a length of at least three inches that may be rolled up for storage or transport. The system, where the EKG device includes: a flexible substrate having first and second sides and first and second ends; a user-activated battery-based power supply mounted on the second side of the substrate and coupled to power-consuming elements of the EKG device; a plurality of flexible electrodes separated into first and second groups each proximate respective first and second ends on the first side of the substrate; an electrically conductive adhesive surface surrounding each electrode of the plurality of electrodes on the first side of the substrate; an electrically non-conductive adhesive surface surrounding each electrically conductive adhesive surface on the first side of the substrate; a release layer covering the adhesive surfaces prior to use; and a signal processor, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with each electrode of the plurality of electrodes. The system, where the EKG device further includes: a processor memory, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the signal processor; a wireless transceiver, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the signal processor and with the processor memory; and where the wireless transceiver is able to receive commands to transmit one of: real-time data from the signal processor; and stored data from the processor memory. The system, where the first computer application is hosted on a device that includes a device able to: receive data from via a wireless link; host the computer application that is capable of creating at least one data product; and display the data and the at least one data product; The system, where the device hosting the first computer application is hosted on a device that is able to communicate, at least partially over a wireless link, with a website server. The system, further including a second computer application hosted on a website server able to: communicate, at least partially over a wireless link, with a computer hosting the computer application; host the a second computer application able to: analyze the data; create at least one data product; format the data for display; store the data and the at least one data product; and provide the data and the at least one data product for display. The system, where the website server is further able to communicate the data and a data product to a medical provider for analysis. 
         [0010]    The present invention further provides a small wireless portable EKG system including; a small, wireless, flexible, and portable EKG device; a first computer application, hosted on a portable device, able to receive wireless data originally sent from the EKG device and to provide the data and/or a data product for display; and a second computer application able to receive wireless data and at least one data product originally sent from the EKG device and to provide the data, a data product, and an additional data product for display. The system, where the EKG device includes: a substrate having first and second sides and first and second ends and further includes one of a wallet card and a roll; a user-activated battery-based power supply, including one or more Zinc-air batteries, mounted on the second side of the substrate and coupled to power-consuming elements of the EKG device; a plurality of electrodes separated into first and second groups each proximate respective first and second ends on the first side of the substrate; an electrically conductive adhesive surface surrounding each electrode of the plurality of electrodes on the first side of the substrate; an electrically non-conductive adhesive surface surrounding each electrically conductive adhesive surface on the first side of the substrate; a release layer covering the adhesive surfaces prior to use; and a signal processor, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with each electrode of the plurality of electrodes and powered by the power supply. The system, where the EKG device further includes: a processor memory, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the signal processor; and a wireless transceiver, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the signal processor and with the processor memory. The system, where the wireless transceiver is able to receive commands to transmit either real-time data from the signal processor or stored data from the processor memory. The system, where the first computer application is hosted on a device that is able to: receive data from via a wireless link; host the computer application that is capable of creating at least one data product; and display the data and a data product. The system, where the first computer application is hosted on a device that is able to communicate with a website server at least partially over a wireless link. The system, further including the second computer application hosted on a website server, the website server able to: communicate, at least partially over a wireless link, with the first computer hosting the first computer application; use the second computer application to: analyze the data; create at least one additional data product using the second computer application; format the data for display; and provide the data and the data product for display; and store the data, the data product, and the additional data product. The system, where the website server is further able to communicate to a medical provider. 
         [0011]    The invention further provides a small wireless portable EKG system including; a small, flexible, wireless, and portable EKG device; a first computer application, hosted on a portable device, able to receive wireless data originally sent from the EKG device and to provide the data and a data product for display; and a second computer application, hosted on a web server, able to receive wireless data and the data product originally sent from the EKG device and to provide the data, the data product, and an additional data product for display. The system, where the EKG device includes: a flexible substrate having first and second sides and first and second ends and includes one of a wallet-sized card and a roll; a user-activated battery-based power supply mounted on the second side of the substrate and including one or more Zinc-air batteries; first and second electrodes proximate respective first and second ends on the first side of the substrate; first and second electrically conductive adhesive surfaces surrounding respective first and second electrodes on the first side of the substrate; an electrically non-conductive adhesive surface between the first and second electrically conductive adhesive surfaces on the first side of the substrate; a release layer covering the adhesive surfaces prior to use; a signal processor, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the first and second electrodes; a processor memory, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the signal processor; and a wireless transceiver, formed of flexible circuitry, positioned underneath the electrically non-conductive adhesive surface and in electronic communication with the signal processor and with the processor memory; where the wireless transceiver is able to receive commands to transmit either real-time data from the signal processor or stored data from the processor memory. The system, where the first computer application is hosted on the portable device that is able to: receive data from the EKG device via a wireless link; host the computer application that is capable of creating a data product; display the data and the data product; accept, store, and communicate user input; and communicate with a website server at least partially over a wireless link. The system, where the web server is able to: communicate, at least partially over a wireless link, with the portable device hosting the first computer application; host the second computer application that is able to: analyze the data; create an additional data product; format the data and the additional data product for display; store the data, the data product, and the additional data product; provide the data, the data product ,and the additional data product for display; and communicate the data, the data product, and the additional data product to a medical provider for analysis. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The above and other objects and advantages of the present invention will become more apparent from the following description taken in conjunction with the following drawings in which: 
           [0013]      FIG. 1A  is a diagrammatic front perspective view illustrating an exemplary EKG device, according to a preferred embodiment of the present invention; 
           [0014]      FIG. 1B  is a diagrammatic rear perspective view illustrating an exemplary EKG device of  FIG. 1A , according to a preferred embodiment of the present invention; 
           [0015]      FIG. 2A  is a diagrammatic front plan view illustrating the exemplary EKG device of  FIG. 1A  with the release layer removed, according to a preferred embodiment of the present invention; 
           [0016]      FIG. 2B  is a diagrammatic plan view illustrating the exemplary EKG device of  FIG. 1A  with the release layer removed, according to a preferred embodiment of the present invention; and 
           [0017]      FIG. 3  is a view illustrating an exemplary EKG system incorporating the EKG device of  FIG. 1 , according to a preferred embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0018]      FIG. 1A  is a diagrammatic front perspective view illustrating an exemplary EKG device  100 , according to a preferred embodiment of the present invention. Release layer  110  covers at least a battery-bearing portion (see  FIG. 2A ) of flexible non-conductive substrate  112 . EKG device  100  includes the flexible non-conductive substrate  112  and a removable wrap-around release layer  110  which, when removed, exposes Zinc-air batteries  2144  (See  FIG. 2A ) to the atmosphere, thereby activating the batteries  214 . Release layer  110  is typically used once, and then discarded after removal. In an alternate embodiment, wireless electrode patch  102  may be refurbished after use, and either a new release layer  110  may be provided or the original may be reused. EKG device  100  preferably has a thickness  104  no greater than fifteen hundredths of an inch, a length  106 , without tab  114 , of no greater than three inches, and a width  108  of no greater than two inches. In various additional embodiments, these size limits may be exceeded. The dimensions  106  and  108  are preferably as small as possible consistent with spacing the electrodes  206  (See  FIG. 2B ) far enough apart to get useful data. The thickness  14  is preferably small enough to allow flexibility and easy carriage, such as in a wallet. Tab  114  extends beyond the length  106  to enable the user to easily grasp the release layer  110  for removal. 
         [0019]      FIG. 1B  is a diagrammatic front perspective view illustrating an exemplary EKG device  100  of  FIG. 1A , according to a preferred embodiment of the present invention. EKG device  100  includes the adhesively attachable wireless electrode patch  102  and the removable wrap-around release layer  110  which, when removed, exposes an adhesive surface for attaching the wireless electrode patch  102  to a patient. 
         [0020]      FIG. 2A  is a diagrammatic front plan view illustrating the exemplary EKG device  100  of  FIG. 1A  with the release layer  110  removed, according to a preferred embodiment of the present invention. Batteries  214  (one of three labeled) are mounted on the flexible non-conductive substrate  112  and are activated when release layer  110  is removed. Removal of release layer  110  is done manually by the user. The first action of removing the release layer from the front of substrate  112  uncovers air holes  201  (one of twelve labeled) on the Zinc-air batteries  214 , allowing air to enter the Zinc-air battery and thereby activate it. The flexible electrical conductors from the batteries  214  to the power-consuming elements of the EKG device  100  are not shown for simplicity of the drawing, but are well known to those of ordinary skill in the art. 
         [0021]      FIG. 2B  is a diagrammatic plan view illustrating an exemplary EKG device  100  of FIG.  1 A with the release layer  110  removed, according to a preferred embodiment of the present invention. Wireless electrode patch  102  has the flexible non-conductive substrate  112  supporting an electrically non-conductive adhesive  202  and electrically conductive adhesive  204  surrounding metallic foil electrodes  206 , as shown. In operation, the metallic foil electrodes  206  are placed in contact with a patient&#39;s skin to pick up electrical signals generated by the heart. The surrounding conductive adhesive  206  maintains the contact between the metallic foil electrodes  206  and the patient&#39;s skin. Non-conductive adhesive  202  covers the remainder of the contact surface of the wireless electrode patch  102  to maintain contact with the patient, without shorting the electrodes  206  to one another. 
         [0022]    Behind the adhesive layer  202  and  204 , and optionally behind the substrate, a signal processor  208  made of flexible circuitry receives signals picked up from metallic foil electrodes  206  via flexible leads  216 . Signal processor  208  processes the raw data from the metallic foil electrodes into an electrocardiogram (EKG), or data product, and stores the electrocardiogram in processor memory  210  via flexible link  218 . Wireless transceiver  212 , also made of flexible circuitry, receives the electrocardiogram from processor memory  210  via flexible link  222  or directly from signal processor  208 , via flexible link  220 , and wirelessly transmits the electrocardiogram or the raw data to a computer  302  (see  FIG. 3 ). The choice of source  208  or  210  of the data and/or data product may be determined by commands received by the wireless transceiver  212 . When EKG device  100  is refurbished, previous EKG data stored in processor memory  210  is erased. 
         [0023]    Zinc-air batteries  214  (one of three labeled can supply power for more than an hour. The advantage of Zinc-air batteries  214  is that they have a very long shelf life as they are not activated until ready to be used. Power linkages to power-consuming elements of the EKG device from the batteries  214  are not shown, as they are well known and would complicate the drawing unnecessarily. In an embodiment meant for refurbishment instead of disposability, the Zinc-air batteries may be replaced during refurbishment. In an additional embodiment, other types of batteries may be used. 
         [0024]      FIG. 3  is a view illustrating an exemplary EKG system  300  incorporating the EKG device  100  of  FIG. 1 , according to a preferred embodiment of the present invention. EKG system  300  includes the EKG device  100 , shown with release layer  110  removed and wireless electrode patch  102  visible, a computer  302  with wireless capability and, optionally, analysis and communication applications on a website server  306  accessible through a website. Computer  302  may be a smart phone, a personal computer, a tablet, PDA, or other type of computer with wireless capability and processing and display capabilities. The wireless link  308  between the wireless electrode patch  102  and the computer  302  may be a Bluetooth, Wi-Fi, broadband, or similar link  308 . In an additional embodiment, a hardwired link may serve as link  308 . In the illustrated example, the computer  302  is a smart phone  302  with a wireless transceiver  314  and display  318  communicatively coupled through an application  316  that formats the electrocardiogram for display  318 . Thus, a user with a smart phone  302  may attach the wireless electrode patch  102  to the patient and observe the heart&#39;s electrical activity on the user&#39;s smart phone  302 . In commerce, the EKG devices  100  may be sold in a kit with a smart phone application  316  and, optionally, a computer or smart phone  302 . Application  316  is part of EKG system  300  which includes the smart phone or computer  302  as well. Application  316  may provide means for associating unique information for identifying the patient with the electrocardiogram. For example, the user may have an opportunity to enter the patient&#39;s name or patient&#39;s ID number into the application  316  using user input features available on the computer or smart phone  302 . Further, information identifying the patient&#39;s medical provider, such as a cardiologist or other medical professional, may be entered to be used to route the electrocardiogram data to that medical provider. 
         [0025]    Computer  302  may further communicate wirelessly with a website on a server  306  to supply the electrocardiogram data for further analysis and/or communication. Website server  306  is coupled to a wireless receiver  304  which receives signals from the wireless transceiver  314  of the computer  302  via wireless link  310  and supplies those signals to website server  306 . The server  306  hosts applications for communication  320  and analysis  324 , as well as providing intrinsic display  326  and storage  322  capability. In the illustrated example, applications for communication  320  and analysis  324  are part of EKG system  300 . The analysis application  324  analyzes the electrocardiogram data and may provide alerts to the user for problematic data, such as that indicating a heart attack or other heart condition. In a preferred additional embodiment, the analysis application  324  may be hosted on smart phone  302  instead of or in addition to server  306 . The communication application  320  responds to either electrocardiogram data or to alerts generated by the analysis application  324  to automatically dial the patient&#39;s cardiologist  330  via link  328 , which may be wireless in whole or in part. Further, the communication application  320  may transfer the electrocardiogram data to cardiologist  330 . In an additional preferred embodiment, the communication application  320  may be hosted on smart phone  302  instead of or in addition to server  306 . In another additional preferred embodiment, wireless transceiver  212  may communicate directly with website server  306 , such as in a hospital environment. 
         [0026]    In exemplary operation, the user of EKG system  300  has in his possession one or more EKG devices  100  and a smart phone  302  with EKG application  316 . The user removes the release layer  110  from the wireless electrode patch  102  and adheres the wireless electrode patch to the patient&#39;s chest. The user then selects the EKG application  316  on smartphone  302 , and observes the patient&#39;s electrocardiogram. The user may remove himself from the immediate vicinity of the patient while observing the electrocardiogram, to the limit of the wireless range of the wireless transceiver  212  on electrode patch  102 , to allow other care providers physical access to the patient. 
         [0027]    In an alternate embodiment, more than two metallic electrodes  206  with surrounding electrically conducting adhesive  204  may be used. For non-limiting example, an EKG device may be a roll having six metallic electrodes  206  with surrounding electrically conducting adhesive  204  that is unrolled as a panel across the patient&#39;s chest as the release layer  110  is removed. The panel is preferably at least three inches long. In another non-limiting example, metallic electrodes  206  with surrounding electrically conducting adhesive  204  may be divided in half vertically to provide four electrodes, one at each corner of electrode patch  102 , without any increase in size. Those of skill in the art, enlightened by the present disclosure, will recognize the wide variety of electrode configurations comprehended by the present invention. 
         [0028]    The novel features of the invention include at least the following: small size; multiple electrodes  206  on a single electrode patch  102 ; wireless transceiver  212 ; internally powered  214  wireless transceiver  212  coupled to both processor memory  210  and signal processor  208  to provide either real-time or stored data; processing capability  208  within the electrode patch  102 ; speed of deployment; at least an hour of stored electrocardiogram data storable in processor memory  210  on the wireless electrode patch  102 ; the computer applications  316 ,  320 , and  324 ; flexible electronic circuits  208 ,  210 ,  212 ,  216 ,  218 ,  220 , and  220  on an electrode patch  102 ; providing alerts to particular heart conditions from an electrode patch  102 ; and alerting a cardiologist to the presence of electrocardiogram data and/or particular conditions identified in the data from the electrode patch  102 . 
         [0029]    While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of the invention.