Patents Assigned to Bardy Diagnostics, Inc.
  • Patent number: 10398334
    Abstract: Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally (in the midline) on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline (or immediately to either side of the sternum) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. Instead, the patient can place an electrode patch anywhere within the general region of the sternum. Ensuring that the quality level of ECG recording remains constant over an extended period of time is provided through self-authentication of electrode patches. The monitor recorder implements a challenge response scheme upon being connected to an electrode patch. Failing self-authentication, the monitor recorder signals an error condition.
    Type: Grant
    Filed: May 22, 2017
    Date of Patent: September 3, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jason Felix, Gust H. Bardy, Jon Mikalson Bishay
  • Patent number: 10390700
    Abstract: Individuals who suffer from certain kinds of medical conditions, particularly conditions that only sporadically exhibit measurable symptoms, can feel helpless in their attempts to secure access to medical care because, at least in part, they are left to the mercy of their condition to present symptoms at the right time to allow diagnosis and treatment. Providing these individuals with ambulatory extended-wear health monitors that record ECG and physiology, preferably available over-the-counter and without health insurance preauthorization, is a first step towards addressing their needs. In addition, these individuals need a way to gain entry into the health care system once a medically-actionable medical condition has been identified. Here, the ECG and physiology is downloaded and evaluated post-monitoring against medical diagnostic criteria.
    Type: Grant
    Filed: November 9, 2018
    Date of Patent: August 27, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Jon Mikalson Bishay
  • Patent number: 10278606
    Abstract: Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.
    Type: Grant
    Filed: October 29, 2018
    Date of Patent: May 7, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jon Mikalson Bishay, Jason Felix, Gust H. Bardy
  • Patent number: 10278603
    Abstract: A system and method for secure physiological data acquisition and storage. An identifier of a physiological monitoring patch is obtained by a programming wand, the patch configured to store the identifier within a cryptographic circuit. A password for accessing physiological monitoring data collected using that patch is generated based on at least a portion of the identifier, the password is encrypted using a secret key, and the encrypted password is loaded into the cryptographic circuit. The key is loaded onto a monitor recorder that couples with the patch and obtains the physiological monitoring data using the patch, wherein the monitor recorder offloads the data together with the identifier and the decoded password. The identifier and the password are reported to a server that stores the offloaded physiological monitoring data using the identifier within a secure database and grants access to the data upon receipt of the decoded password.
    Type: Grant
    Filed: April 30, 2018
    Date of Patent: May 7, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jason Felix, Ezra M. Dreisbach, Jon Mikalson Bishay, Corey Bailey Williamson, Gust H. Bardy
  • Patent number: 10271755
    Abstract: A method for constructing a stress-pliant physiological electrode assembly is provided. An electrode backing is formed from a stretchable woven textile material compatible to contact the skin on at least one surface. A pair of flexile wires is provided to serve as electrode circuit trace and electrode signal pickup. At least one of the flexile wires is sewn into the textile material which provides a stress-pliant malleability. Each of the flexile wires has an electrically-contacting area functioning for electric signal pickup. The electrically-contacting area may be sewn into the woven textile or affixed to the woven textile via conductive adhesives. The stress-pliant physiological electrode assembly is applicable for a wide array of physiological monitors, including ECG monitors, and especially is suitable for long-term wear. The method disclosed is both environmentally friendly and low-cost.
    Type: Grant
    Filed: October 2, 2017
    Date of Patent: April 30, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jason Felix, Jon Mikalson Bishay, Gust H. Bardy
  • Patent number: 10271756
    Abstract: Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally (in the midline) on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and, to a lesser extent, the QRS interval signals indicating ventricular activity in the ECG waveforms. Additionally, the monitor recorder includes an ECG sensing circuit that measures raw cutaneous electrical signals and performs signal processing prior to outputting the processed signals for sampling and storage.
    Type: Grant
    Filed: April 30, 2018
    Date of Patent: April 30, 2019
    Assignee: BARDY DIAGNOSTICS, INC.
    Inventors: Jason Felix, Jon Mikalson Bishay, Gust H. Bardy
  • Patent number: 10264992
    Abstract: Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch with sewn electrodes and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.
    Type: Grant
    Filed: July 27, 2017
    Date of Patent: April 23, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jason Felix, Jon Mikalson Bishay, Gust H. Bardy
  • Patent number: 10265015
    Abstract: A monitor recorder optimized for electrocardiography and respiratory data acquisition and processing is provided.
    Type: Grant
    Filed: April 30, 2018
    Date of Patent: April 23, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Jon Mikalson Bishay, Jason Felix
  • Patent number: 10251576
    Abstract: A system and method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders is provided. ECG data is obtained via an electrocardiography monitor with a patient button. A press of the patient button is identified within the ECG data. A button window with a segment of data prior to and after the button press is defined within the ECG data. The ECG data is divided into blocks. Noise detection analysis is applied to the data blocks. A classification of noise or valid data is assigned to each data block based on the noise detection analysis. At least one data block that overlaps the button window is assigned the noise classification. The at least one data block is trimmed to align with one of the start and end of the button window. The trimmed blocks assigned with the noise classification are removed from the data.
    Type: Grant
    Filed: March 23, 2018
    Date of Patent: April 9, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Ezra M. Dreisbach
  • Patent number: 10251575
    Abstract: A wearable electrocardiography monitoring ensemble is provided, which includes a garment made of a compressible and elastomeric material. The garment is wearable about an upper region of the torso and further includes an internal structure forming a compressive bias circumferential to the torso. The ensemble also includes an electrode assembly provided on an inside surface of the garment on an underside of the internal structure. The electrode assembly has a pair of electrocardiography electrodes, a pair of terminated electrical connections that are each coupled to one of the electrocardiography electrodes, and a backing to which the electrocardiography electrodes are affixed.
    Type: Grant
    Filed: May 22, 2017
    Date of Patent: April 9, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Mark Handfelt, Jon Mikalson Bishay, Jason Felix
  • Patent number: 10172534
    Abstract: A remotely-interfaceable electrocardiography patch is provided. A flexible backing is formed from an elongated strip of material. A pair of electrocardiographic electrodes are exposed on a contact surface of the flexible backing for capturing electrocardiographic signals. A non-conductive receptacle is adhered to an outward-facing surface of the flexible backing and includes a plurality of electrical pads. A flexible circuit has a pair of circuit traces electrically coupled to the pair of electrocardiographic electrodes and a pair of the electrical pads. A wireless transceiver communicates samples of the electrocardiographic signals.
    Type: Grant
    Filed: November 20, 2017
    Date of Patent: January 8, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jason Felix, Jon Mikalson Bishay, Gust H. Bardy
  • Patent number: 10165946
    Abstract: Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline (or immediately to either side of the sternum) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. The wearable monitor can interoperate wirelessly with other physiology and activity sensors and mobile devices. An application executed by the sensor or device can trigger the dispatch of a wearable monitor to the patient upon detecting potentially medically-significant events. The dispatched wearable monitor would then be capable of providing precise medically-actionable data, not merely an alert that some abnormality may be present.
    Type: Grant
    Filed: March 17, 2014
    Date of Patent: January 1, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Jason Felix, Jon Mikalson Bishay
  • Patent number: 10154793
    Abstract: Physiological monitoring can be provided through a wearable monitor that includes a flexible extended wear electrode patch and a removable reusable monitor recorder. A pair of flexile wires is interlaced or sewn into a flexible backing, serving as electrode signal pickup and electrode circuit traces. The wearable monitor sits centrally on the patient's chest along the sternum, which significantly improves the ability to sense cutaneously cardiac electric signals, particularly those generated by the atrium. The electrode patch is shaped to fit comfortably and conformal to the contours of the chest approximately centered on the sternal midline. To counter the dislodgment due to compressional and torsional forces, non-irritating adhesive is provided on the underside, or contact, surface of the electrode patch, but only on the distal and proximal ends.
    Type: Grant
    Filed: July 27, 2017
    Date of Patent: December 18, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jason Felix, Jon Mikalson Bishay, Gust H. Bardy
  • Patent number: 10123703
    Abstract: Individuals who suffer from certain kinds of medical conditions, particularly conditions that only sporadically exhibit measurable symptoms, can feel helpless in their attempts to secure access to medical care because, at least in part, they are left to the mercy of their condition to present symptoms at the right time to allow diagnosis and treatment. Providing these individuals with ambulatory extended-wear health monitors that record ECG and physiology, preferably available over-the-counter and without health insurance preauthorization, is a first step towards addressing their needs. In addition, these individuals need a way to gain entry into the health care system once a medically-actionable medical condition has been identified. Here, the ECG and physiology is downloaded and evaluated post-monitoring against medical diagnostic criteria.
    Type: Grant
    Filed: April 9, 2018
    Date of Patent: November 13, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Jon Mikalson Bishay
  • Patent number: 10111601
    Abstract: Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.
    Type: Grant
    Filed: July 10, 2017
    Date of Patent: October 30, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jon Mikalson Bishay, Jason Felix, Gust H. Bardy
  • Patent number: 10052022
    Abstract: In one embodiment, a system and method for providing dynamic gain over non-noise electrocardiographic data with the aid of a digital computer are provided. A time series of a plurality of voltage values that comprises a digital representation of a raw electrocardiography (“ECG”) signal recorded by an ambulatory monitor recorder is obtained. One or more segments of the ECG signal is marked as noise, each of the segments including a plurality of the values, based on a difference between a maximum one and a minimum one of the values within that segment. Further segments not marked as noise are analyzed, each of the segments comprising a plurality of the values. A gain factor for all of the values in the analyzed further segments is determined based on the analysis.
    Type: Grant
    Filed: August 21, 2017
    Date of Patent: August 21, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Jason Felix, Jon Mikalson Bishay, Ezra M. Dreisbach
  • Patent number: 10045709
    Abstract: A system and method for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer are provided. Cutaneous action potentials of a patient are recorded as electrocardiogram (ECG) data over a set time period. A set of R-wave peaks is identified within the ECG data and an R-R interval plot is constructed. A difference between recording times of successive pairs of the R-wave peaks in the set is determined. A heart rate associated with each difference is also determined. The pairs of the R-wave peaks and associated heart rate are plotted as the R-R interval plot. A diagnosis of cardiac disorder is facilitated based on patterns of the plotted pairs of the R-wave peaks and the associated heart rates in the R-R interval plot.
    Type: Grant
    Filed: August 8, 2016
    Date of Patent: August 14, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Ezra M. Dreisbach
  • Patent number: 10004415
    Abstract: An extended wear electrocardiography patch is provided. A flexible backing is formed of an elongated strip of stretchable spunlace material. A layer of stretchable adhesive is applied on at least a portion of a contact surface of the flexible backing, which defines a pair of openings on both ends. A non-stretchable circuit is axially affixed to an outward-facing surface of the flexible backing and has a pair of circuit traces. The flexible backing acts as a buffer between the non-stretchable circuit and the stretchable adhesive and prevents disadhesion of the flexible backing during bending. A pair of electrocardiographic electrodes are electrically coupled to each of the circuit traces. Conductive gel is provided in each of the openings and in electrical contact with the pair of electrocardiographic electrodes as the electrodes shift away from the openings in the flexible backing during the bending.
    Type: Grant
    Filed: September 2, 2016
    Date of Patent: June 26, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jon Mikalson Bishay, Gust H. Bardy, Jason Felix
  • Patent number: D831833
    Type: Grant
    Filed: July 31, 2017
    Date of Patent: October 23, 2018
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Jon Mikalson Bishay, Gust H. Bardy
  • Patent number: D838370
    Type: Grant
    Filed: November 17, 2014
    Date of Patent: January 15, 2019
    Assignee: Bardy Diagnostics, Inc.
    Inventors: Gust H. Bardy, Jon Mikalson Bishay