Imbalances of potassium levels is a leading cause of death in patients undergoing dialysis. Here, a method for maintaining serum potassium homeostasis through subcutaneous monitoring is provided. Electrocardiographic (ECG) manifestations and, in a further embodiment, arrhythmia characteristics indicative of an onset and existence of loss of serum potassium homeostasis in a patient on dialysis are maintained. ECG signals of the patient's heart are subcutaneously monitored continuously on a beat-by-beat basis. The ECG signals are processed in real time as a set of ECG traces with each ECG trace being representative of the net electrical activity of the heart at a given moment in time. Each ECG trace is evaluated against the set of ECG manifestations and, in a further embodiment, over time against the arrhythmia characteristics. An alert of medical condition is generated upon a recognition of at least one of the ECG manifestations in the ECG traces.
An insertable physiological monitor injector tool is provided. An elongated handle includes a recess formed along a longitudinal axis and has an opening on a distal end. An insertion tube has a hollow elongated shape that is movably positioned within the elongated handle, in the recess. A retention hinge is cut from a surface of the insertion tube and formed as a curve in an interior of the tube. A stationary arbor is affixed on a proximal end to a proximal end of the elongated handle and extends through the insertion tube when the insertion tube is in a retracted position. A tab is affixed to the insertion tube, wherein the tab can lock the insertion tube in an extended position.
A61M 5/00 - Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
An insertable physiological monitor injector tool is provided. An elongated handle (11) includes a recess (12) formed along a longitudinal axis and has an opening on a distal end. An insertion tube (16) has a hollow elongated shape that is movably positioned within the elongated handle (11), in the recess (12). A stationary arbor (15) is affixed on a proximal end to a proximal end of the elongated handle (11) and extends through the insertion tube (16) when the insertion tube (16) is in a retracted position. A tab (18) is affixed to the insertion tube (16), wherein the tab (18) can lock the insertion tube (16) in an extended position.
A system (140) for facilitating a cardiac rhythm disorder diagnosis is provided. A download station (145) retrieves cutaneous action potentials of a patient recorded over a time by an ECG device (142) as ECG data. An R-R interval plot (53) of the ECG data includes R-R intervals plotted along an x-axis of the plot (53) and heart rates associated with the R-R intervals plotted along a y-axis. The R-R intervals are calculated as a difference between recording times of successive pairs of R-wave peaks. Each heart rate is associated with each time difference. One or more portions of the R-R intervals are identified in the plot (53). Each portion of the R-R intervals includes a cardiac event. Report strips (442) are generated and each includes one portion of the R-R intervals and a portion of the ECG data. The report strips (442) are included in a cardiac report.
An electrocardiography patch (15) is provided. A backing (20) includes an elongated strip (21) of material. An electrocardiographic electrode (38, 39) is respectively affixed to and exposed on each end of the elongated strip (21). A flexible circuit (32) is affixed on each end of the elongated strip (21) and includes a pair of circuit traces (33, 37) each coupled to one of the electrocardiographic electrodes (38, 39). A receptacle (25) is adhered on one end of the elongated strip (21) and includes electrode terminals aligned to interface the pair of circuit traces (33, 37) to an electrocardiography monitor (14) to obtain electrocardiographic signals through the electrocardiographic electrodes (38, 39). A crypto circuit (103) includes memory programed with a sampling rate for at least one physiological sensor provided with the electrocardiography monitor (14) or on the flexible backing (20) to instruct the physiological sensor to obtain readings of physiological data.
A self-expiring electrocardiography and physiological monitor recorder (14) is provided. A sealed housing (50) is adapted to be removably secured into a non-conductive receptacle (25) on an electrode patch (15). Electronic circuity is provided within the sealed housing (50) and includes an electrocardiographic front end circuit (93) operable to sense electrocardiographic signals through electrocardiographic electrodes (38, 39) provided on the electrode patch (15) and flash memory to record the electrocardiographic signals. The electronic circuitry also includes a micro-controller to draw power from a battery (79) provided on the electrode patch (15), to receive from the electrode patch (15) a recording duration, and to terminate recording of the electrocardiographic signals upon satisfaction of the recording duration.
Physiological monitoring can be provided through a wearable monitor (112) that includes a flexible extended wear electrode patch (115) and a removable reusable monitor (112) recorder. The wearable monitor (112) sits centrally on the patient's chest along the sternum (13), which significantly improves the ability to sense cutaneously cardiac electric signals, particularly those generated by the atrium. The electrode patch (115) is shaped to fit comfortably and conformal to the contours of the chest approximately centered on the sternal midline (16). The electrode patch (115) is made from a type of stretchable spunlace fabric. To counter patient bending motions and prevent disadhesion of the electrode patch (115), the outward-facing aspect of the backing (116), to which a (non-stretchable) flexible circuit (117) is fixedly attached, stretches at a different rate than the backing's (116) skin-facing aspect, where a skin adhesive (119) removably affixes the electrode patch (115) to the skin.
A wearable electrocardiography monitoring ensemble (300) is provided, which includes a garment (301) made of a compressible and elastomeric material. The garment (301) is wearable about an upper region of the torso (305) and further includes an internal structure (302) forming a compressive bias circumferential to the torso (305). The ensemble (300) also includes an electrode assembly (313) provided on an inside surface of the garment (301) on an underside of the internal structure (302). The electrode assembly (313) has a pair of electrocardiography electrodes (309, 310), a pair of terminated electrical connections (311, 312) that are each coupled to one of the electrocardiography electrodes (309, 310), and a backing (20) to which the electrocardiography electrodes (309, 310) are affixed. The wearable monitoring ensemble (300) creates a more natural experience for wearers and can be used to produce an expanded dataset for diagnosis because the ensemble (300) can collect data during activities of daily living and can capture cardiovascular events outside of clinical observation, which is otherwise not practicable, especially for athletes.
Physiological monitoring can be provided through a syncope sensor (64, 66) embedded into an electrocardiography monitor (12), which correlates syncope events and electrocardiographic data. Physiological monitoring can be provided through a lightweight wearable monitor (12) that includes two components: a flexible extended-wear electrode patch (15) and a reusable monitor recorder (14) that removably snaps into a receptacle (25) on the electrode patch (15). The wearable monitor (12) sits centrally on the patient's sternal midline (16) and includes a unique narrow "hourglass"-like shape, significantly improving the ability of the monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and QRS interval signals. The electrocardiographic electrodes (38, 39) on the electrode patch (15) are tailored for axial positioning along the midline (16) of the sternum (13) to capture action potential propagation in an orientation that corresponds to the aVF lead in a conventional 12-lead electrocardiogram, which senses positive P-waves (271).
R-R interval data is presented (24) in a format that includes relevant near field and far field ECG data. The near field view (51) provides a "pinpoint" classical view at classical recording speed. The far field view (52) provides an "intermediate" lower resolution, pre- and post-event view. Both ECG data views (51, 52) are temporally keyed to the extended duration R-R interval data (53) that is scaled non-linearly to maximize the visual differentiation for frequently-occurring heart rate ranges. The views (51, 52, 53) are presented simultaneously and their durations are flexible and adjustable. Diagnostically relevant cardiac events can be identified (23) and located to allow pre- and post-event heart rhythm data. The pinpoint "snapshot" and intermediate views of ECG data (56, 166) with the extended term R-R interval data (53) comparatively depicts heart rate context and patterns of behavior prior to and after a clinically meaningful arrhythmia or patient concern.
A method (200) for efficiently encoding and compressing ECG data optimized for use in an ambulatory electrocardiography monitor is provided. ECG data is first encoded and compressed (202) in a lossy process and further encoded and compressed (203) in a lossless process. A compression ratio significantly higher than other Holter-type monitors is achieved. Requirements for storage space and power cell consumption are reduced, contributing to the long-term availability of the monitor.
Physiological monitoring is provided through a lightweight wearable monitor (12) that includes a flexible extended wear electrode patch (15) and a reusable monitor recorder (14) that removably snaps into a receptacle (25) on the electrode patch (15). The wearable monitor (12) sits centrally along the sternum (13) oriented top-to-bottom. Placement of the wearable monitor (12) in a location at the sternal midline (16), with its unique narrow "hourglass"-like shape, significantly improves the ability of the wearable monitor (12) to cutaneously sense cardiac electrical potential signals, particularly P-wave and QRS interval signals indicating ventricular activity in ECG waveforms. The monitor recorder (12) includes an ECG sensing circuit that measures raw cutaneous electrical signals using a driven reference containing power supply noise and system noise to the reference lead, which is critical to preserving characteristics of low amplitude cardiac action potentials, particularly P-waves (121).
Physiological monitoring is provided through a lightweight wearable monitor (12) that includes a flexible extended wear electrode patch (15) and a reusable monitor recorder (14) that removably snaps into a receptacle (25) on the electrode patch (15). The wearable monitor (12) sits centrally on a patient's chest along the sternum (13) oriented top-to-bottom. Placement of the wearable monitor (12) at the sternal midline (16), with its unique narrow "hourglass"-like shape, significantly improves the ability of the wearable monitor (12) to cutaneously sense cardiac electrical potential signals, particularly P-wave and QRS interval signals indicating ventricular activity in the ECG waveforms. ECG electrodes (38, 39) on the electrode patch (15) are tailored to be positioned axially along the midline (16) of the sternum (13) for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG used to sense positive or upright P-waves (121).
Physiological monitoring is provided through a lightweight wearable monitor (12) that includes a flexible extended wear electrode patch (15) and a reusable monitor recorder (14) that removably snaps into a receptacle (25) on the electrode patch (15). The wearable monitor (12) sits centrally along a patient's sternum (13) oriented top-to-bottom. Placement of the wearable monitor (12) at the sternal midline (16), with its unique narrow "hourglass"-like shape, significantly improves the ability of the wearable monitor (12) to cutaneously sense cardiac electrical potential signals, particularly P-wave and QRS interval signals indicating ventricular activity in ECG waveforms. ECG electrodes (38, 39) on the electrode patch (15) are tailored to be positioned axially along the midline (16) of the sternum (13) for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG used to sense positive or upright P-waves (121).
Physiological monitoring can be provided through an actigraphy sensor (64) imbedded into an electrocardiography monitor (12), which correlates movement and electrocardiographic data. Physiological monitoring can be provided through a wearable monitor (12) that includes two components, a flexible extended wear electrode patch (15) and a removable reusable monitor recorder (14). The monitor (12) sits centrally on the patient's chest along the sternum (13). The patient can place a patch (15) anywhere within the general region of the sternum (13). The occurrence of actigraphy events are monitored by the recorder (14) through an actigraphy sensor (64). Actigraphy becomes a recordable actigraphy event occurrence when the movement of the monitor (12) and, therefore, the patient (10, 11), exceeds a criteria threshold of acceleration or deceleration as detected by the actigraphy sensor (64). Certain actigraphy event occurrences are considered actionable, of sufficient importance to warrant flagging for further consideration to a following physician.
Physiological monitoring can be provided through a wearable monitor (12) that includes two components, a flexible extended wear electrode patch (15) and a removable reusable monitor recorder (14). The placement of the monitor (12) in a location at the sternal midline (16) (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 throughout the monitoring. The monitor (12) can interoperate wirelessly with other physiology and activity sensors (131) and mobile devices (132). An application (132) executed by the sensor (131) or device (133) can trigger the dispatch of a wearable monitor (12) to the patient upon detecting potentially medically-significant events. The monitor (12) would then be capable of providing precise medically-actionable data. The patient (10, 11) can then use the sensor (131) or device (133) to record the placement and use of the monitor (12).
Physiological monitoring can be provided through a wearable monitor (12) that includes a flexible extended wear electrode patch (15) and a removable reusable monitor recorder (14). A pair of flexile wires (61, 71) is interlaced or sewn into a flexible backing (20), serving as electrode signal pickup and electrode circuit traces. The monitor (12) sits centrally on the patient's chest along the sternum (13), which significantly improves the ability to sense cutaneously cardiac electric signals, particularly those generated by the atrium. To counter the dislodgment due to compressional and torsional forces, non-irritating adhesive (43) is provided on the underside, or contact, surface of the electrode patch (15), but only on the distal (30) and proximal ends (31). Interlacing the flexile wires (61, 71) into the flexile backing (20) also provides structural support and malleability against compressional, tensile and torsional forces.
A system (40) and method (60) for interactive processing of ECG data (10) are presented. An electrocardiogram is displayed (63). A user selection of a portion of the displayed ECG (10) is received (64). Digitized signals corresponding to the selection are obtained (65). A list of digital filters (56) for filtering the selection are displayed (67). A user selection of one or more sets of the digital filters (56) is received (69), with each of the sets including one or more of the filters (56) from the list. The selected sets are applied (70) to the digitized signals for the selection. A filtered ECG (10) for the selection is generated (71) for each of the sets based on the signals filtered by that set. The filtered selection ECG for each of the sets are presented (71) on the display.
A61B 5/0452 - Detecting specific parameters of the electrocardiograph cycle
A61B 5/04 - Measuring bioelectric signals of the body or parts thereof
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
Physiological monitoring can be provided through a wearable monitor (12, 180) that includes two components, a flexible extended wear electrode patch (15, 181) and a removable reusable monitor recorder (14). The monitor (12) sits centrally (in the midline (16)) on the patient's chest along the sternum (13) oriented top-to-bottom. The placement of the monitor (12) in a location at the sternal midline (16) (or immediately to either side of the sternum (13)) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots throughout the monitoring. Instead, the patient can place an electrode patch (15) anywhere within the general region of the sternum (13). Power is provided through a battery (71, 197) provided on the patch (15, 181). The monitor (12, 180) further includes sensors (42, 69, 75, 191-195) for monitoring patient's air flow and respiratory measures contemporaneously with the ECG monitoring.
Physiological monitoring can be provided through a wearable monitor (12) that includes two components, a flexible extended wear electrode patch (15) and a removable reusable monitor recorder (14). The monitor (12) sits centrally (in the midline (16)) on the patient's chest along the sternum (13) oriented top-to-bottom. The placement of the monitor (12) in a location at the sternal midline (16) or immediately to either side of the sternum (13)) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots throughout the monitoring. Instead, the patient can place a patch (15) anywhere within the general region of the sternum (13). Ensuring that the quality of ECG recording remains constant over an extended period is provided through self-authentication of patches (15). The recorder (14) implements a challenge response scheme upon being connected to a patch (15). Failing self-authentication, the recorder (14) signals an error.