Method and apparatus to detect, characterize, and / or control cardiac arrhythmia using a wearable electrocardiographic device

Abstract

An example method of performing wearable cardiac monitoring includes positioning a plurality of wireless ECG electrodes on a patient; calibrating the plurality of wireless ECG electrodes, receiving, from the plurality of wireless ECG electrodes, a cardiac measurement, receiving, from an ICD, an ICD measurement; and determining, based on the ICD measurement and the cardiac measurement, the presence or absence of an arrhythmia. An example system includes: a plurality of wearable ECG leads, a controller operably coupled to the plurality of wearable ECG leads, the controller having a memory with computer-readable instruction stored thereon, where execution of the computer-readable instruction by the controller causes the processor to receive a plurality of ECG signals from the wearable ECG leads, and output, based on the ECG signals, a cardiac measurement.

Description

Method and Apparatus to Detect, Characterize, and / or Control Cardiac Arrhythmia using a Wearable Electrocardiographic DeviceRELATED APPLICATION

[0001] This application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63 / 514,502, filed July 19, 2023, entitled "Method and Apparatus to Detect, Characterize, and / or Control Cardiac Arrhythmia using a Wearable Electrocardiographic Device," which is incorporated by reference herein in its entirety.BACKGROUND

[0002] Electrocardiography refers to measurement of electrical activity of the heart. A common form of electrocardiography is a medical test referred to as an "electrocardiogram." In an electrocardiogram, measurements of electrical potentials are collected using electrodes, which are commonly located on a patient's skin. These electrical potentials can be used to monitor the functioning of the heart, for example by detecting the electrical potentials associated with a heartbeat. In turn, this enables electrocardiograms to detect conditions such as arrythmia. Improvements to electrocardiography can benefit the diagnosis and / or treatment of cardiac conditions.SUMMARY

[0003] In some aspects, implementations of the present disclosure include a system including: a plurality of wearable ECG leads; a controller operably coupled to the plurality of wearable ECG leads, the controller including a processor and a memory with computer- readable instruction stored thereon, wherein execution of the computer-readable instruction by the controller causes the processor to: receive a plurality of ECG signals from the wearableECG leads; and output, based on the ECG signals, a cardiac measurement.

[0004] In some aspects, implementations of the present disclosure include a system, wherein the system further includes an implantable cardioverter defibrillator ( ICD) operably coupled to the controller, wherein the ICD is configured to receive the cardiac measurement.

[0005] In some aspects, implementations of the present disclosure include a system, wherein the system further includes an automatic cardioverter defibrillator (ACD), wherein the ACD is configured to receive the cardiac measurement.

[0006] In some aspects, implementations of the present disclosure include a system, wherein the ICD is further configured to deliver an ICD shock based at least in part on the cardiac measurement.

[0007] In some aspects, implementations of the present disclosure include a system or claim 4, wherein the ICD is configured to transmit an ICD measurement to the controller, and wherein the cardiac measurement is based at least in part on the cardiac measurement.

[0008] In some aspects, implementations of the present disclosure include a system, wherein the controller is further configured to synchronize the signals of the ECG leads.

[0009] In some aspects, implementations of the present disclosure include a system, wherein synchronizing the signals of the ECG leads includes correcting the synchronicity of the ECG leads.

[0010] In some aspects, implementations of the present disclosure include a system, wherein synchronizing the signals of the ECG leads includes correcting a latency of the ECG leads.

[0011] In some aspects, implementations of the present disclosure include a system, wherein the plurality of ECG leads include a base station ECG lead, wherein the base stationECG lead includes the controller.

[0012] In some aspects, implementations of the present disclosure include a system, further including a mobile computing device in operable communication with the base station ECG lead.

[0013] In some aspects, implementations of the present disclosure include a system, further including a remote computing device in operable communication with the base station ECG lead or the mobile computing device.

[0014] In some aspects, implementations of the present disclosure include a system, further including at least one biosensor operably coupled to the controller, wherein the biosensor is configured to output a biosensor measurement.

[0015] In some aspects, implementations of the present disclosure include a system, wherein the biosensor includes at least one of a PPG sensor, pulse oximetry sensor, or bioimpedance sensor.

[0016] In some aspects, implementations of the present disclosure include a system, wherein the biosensor measurement includes at least one of a fluid monitoring measurement, autonomic nervous system output measurement, or PPG-derived blood pressure measurement blood pressure.

[0017] In some aspects, implementations of the present disclosure include a system, wherein the memory further includes instructions that cause the processor to output a characterization of a cardiac event based on the cardiac measurement and the biosensor measurement.

[0018] In some aspects, implementations of the present disclosure include a method of performing wearable cardiac monitoring, the method including: positioning a plurality of wireless ECG electrodes on a patient; calibrating the plurality of wireless ECG electrodes; receiving, from the plurality of wireless ECG electrodes, a cardiac measurement; receiving, froman ICD, an ICD measurement; and determining, based on the ICD measurement and the cardiac measurement, a presence or absence of an arrhythmia.

[0019] In some aspects, implementations of the present disclosure include a method, wherein calibrating the plurality of wireless ECG electrodes includes optimizing a detection of P- waves by configuring the position of the plurality of wireless ECG electrodes on the patient.

[0020] In some aspects, implementations of the present disclosure include a method, wherein at least one of the plurality of wireless ECG electrodes is placed on a limb of the patient.

[0021] In some aspects, implementations of the present disclosure include a method, further including locating the arrhythmia.

[0022] In some aspects, implementations of the present disclosure include a method, further including delivering an ICD shock based on the presence or absence of an arrhythmia.

[0023] It should be understood that the above-described subject matter may also be implemented as a computer-controlled apparatus, a computer process, a computing system, or an article of manufacture, such as a computer-readable storage medium.

[0024] Other systems, methods, features and / or advantages will be or may become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features and / or advantages be included within this description and be protected by the accompanying claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1A illustrates an example system including ECG leads and an ECG lead base station, according to implementations of the present disclosure.

[0026] FIG. IB illustrates an example system including ECG leads and ECG lead base stations, according to implementations of the present disclosure.

[0027] FIG. 1C illustrates an example system including ECG leads and ECG lead base Stations, where the ECG lead base stations are in communication with each other, according to implementations of the present disclosure.

[0028] FIG. ID illustrates an example system including ECG leads and a mobile device, where the ECG leads are in communication with the same mobile device, according to implementations of the present disclosure.

[0029] FIG. 2A illustrates an example system including an array of ECG leads including an ECG lead base station and used with a mobile device, according to implementations of the present disclosure.

[0030] FIG. 2B illustrates an example system including an array of ECG leads and ECG lead base stations, used with a mobile device, according to implementations of the present disclosure.

[0031] FIG. 2C illustrates an example system including an array of ECG leads and ECG lead base stations, used with a mobile device, according to implementations of the present disclosure.

[0032] FIG. 3A illustrates an example system including ECG leads used with an ICD unit to implement a wearable electrocardiogram monitor device according to implementations of the present disclosure.

[0033] FIG. 3B illustrates an example system including ECG leads with two ECG lead base stations as part of a wearable electrocardiogram monitor device used with an ICD unit, according to implementations of the present disclosure.

[0034] FIG. 3C illustrates an example system including a wearable electrocardiogram monitor device including an array of ECG leads with two ECG Lead base stations and a mobiledevice, where the wearable electrocardiogram monitor device is in operable communication with an ICD unit, according to implementations of the present disclosure.

[0035] FIG. 4A illustrates an example system including a mobile device, a wearable electrocardiogram monitor device (including an array of ECG leads and ECG lead base station), and database, according to implementations of the present disclosure.

[0036] FIG. 4B illustrates an example system including a mobile device, ICD unit, database, and a wearable electrocardiogram monitor device (including an ECG lead base station and array of ECG leads) according to implementations of the present disclosure.

[0037] FIG. 4C illustrates an example system including a mobile device, array of ECG leads, AICD unit, and wearable electrocardiogram monitor device (including a ECG leads and ECG lead base station), according to implementations of the present disclosure.

[0038] FIG. 4D illustrates an example system including a mobile device, AICD unit, database, and wearable electrocardiogram monitor device (including a ECG lead base station and ECG leads), according to implementations of the present disclosure.

[0039] FIG. 5A illustrates heart and normal sinus rhythm, according to implementations of the present disclosure.

[0040] FIG. 5B illustrates a heart and ventricular tachycardia, according to implementations of the present disclosure.

[0041] FIG. 6 illustrates an example method for determining a presence or absence of an arrhythmia, according to implementations of the present disclosure.

[0042] FIG. 7 illustrates an example method of determining to administer a shock using a defibrillator, according to implementations of the present disclosure.

[0043] FIG. 8 illustrates an example system for determining whether to administer a shock using a defibrillator, according to implementations of the present disclosure.

[0044] FIG. 9 illustrates an example computing device.

[0045] FIG. 10 illustrates an example algorithm that can be used to implement methods of determining to deliver an ICD shock, according to implementations of the present disclosure.DETAILED DESCRIPTION

[0046] Implementations of the present disclosure include improvements to devices for performing electrocardiograms. Specifically, the example implementations of the present disclosure described herein include improvements to wearable devices for performing ECG, which can be in used in combination with defibrillators to more accurately determine when a shock should be administered to a patient. The use of wearable devices external to the heart can improve the diagnosis of types of arrhythmia, and thereby distinguish between arrhythmias that should be treated with a defibrillator (e.g., shocked), from arrhythmias that can be treated using other devices and / or methods. As used herein, the term "defibrillator" refers to any cardiac defibrillator, non-limiting examples of which include Automatic Implantable Cardioverter-Defibrillators (AICD), automatic cardioverter defibrillators (ACD), and / or implantable cardioverter defibrillators (ICDs). Therefore while implementations of the present disclosure are described with reference to types of defibrillators (ICDs, ACDs, AICDs) it should be understood that these are non-limiting examples and that the systems and methods herein can be used to improve the diagnosis and treatment of cardiac conditions in systems with any type of defibrillator.

[0047] The wearable devices described herein can also enable the collection of accurate ECG data over long periods of time (e.g., a whole day or week). The ECG data collected can be ECG data that includes localization information about the ECG signals and can be collected using multiple wearable electrodes. Alternatively or additionally, the electrodes usedin the systems and methods described herein can be configured to transmit ECG data, for example to an implantable device or to an external monitoring device. By collecting long-term ECG data, the implementations of the present disclosure can be used to improve the diagnosis and treatment of cardiac conditions.

[0048] For example, implementations of the present disclosure can be used to improve electrocardiograms for the monitoring and triggering of implantable cardioverter defibrillators (ICDs). Existing ICDs operate or function as a closed loop therapy by detecting and characterizing an arrhythmia, and if treatment is appropriate, delivering a capacitor-stored discharge of electrical energy to stop and reboot the heart to restore regular rhythm. Such shocks are painful and are delivered at the appropriate time during the cardiac cycle and with the appropriate voltage to be successful while avoiding damage / injury to normal cardiac tissues.

[0049] In operation, the ICD senses the local cardiac electrical activity using implanted leads as a local electrocardiogram ]ECG) source. This has an advantage of avoiding signal noise sensed from electrodes when disposed on the surface of the body, but a disadvantage of being so close together that the three-dimensional morphology of cardiac complexes is difficult to differentiate. This can be important because not all ventricular arrhythmias, usually those emanating from the right ventricle, whether PVCs or VT require an ICD shock or ablative procedure. In contrast, the same arrhythmias emanating from the left ventricle can be lethal and, as such, deserve or require treatment.

[0050] Erroneous / inappropriate ICD discharges are a serious problem. They are unpleasant for the patient to endure, drain the power source (e.g., battery) of the ICD, can damage healthy tissue, and can trigger a serious arrhythmia or cause death. The incidence of inappropriate ICD shocks is estimated at 20% of all ICD discharges. Inappropriate ICD dischargesresult from a failure of the ICD to correctly characterize the ECG morphology. A method that can enhance the ICDs ability to determine the three-dimensional vector of ventricular arrhythmias, for instance differentiate right ventricular origin from left ventricular origin wherein if determined to be originating locally in the left ventricle, treatment would substantially reduce the incidence of inappropriate ICD shocks. Similarly, a method that can reduce the mis-categorization of Atrial Fibrillation and supraventricular tachycardia (SVT) as VT would also substantially limit or reduce inappropriate, unnecessary or erroneous ICD shocks.

[0051] Moreover, with more rapid and accurate ECG characterization, ICD performance would also be enhanced by improving reaction time - that is, the time from detection to treatment. This would occur because the ICD detection and characterization algorithm would require fewer beats to make an accurate three-dimensional diagnosis of the anatomic location of the ventricular arrythmia's source.

[0052] Additionally, implementations of the present disclosure include improvements to cardiac ablation. For example, ventricular tachycardia (VT) treatment and premature ventricular contraction (PVC) treatment.

[0053] Clinically, an important cardiac arrhythmia is ventricular tachycardia. ICDs are designed to detect and terminate cardiac arrhythmia by, for example, anti-tachycardia pacing or a direct current shock. Ventricular tachycardia (VT or V-tach) is a type of abnormal heart rhythm, or arrhythmia. It occurs when the lower chamber of the heart beats too fast to pump well and the body doesn't receive enough oxygenated blood.

[0054] A normal heartbeat begins with an electrical impulse from the sinus node, a small area in the heart's right atrium (right upper chamber). Ventricular tachycardia begins in the lower chambers (ventricles) and is quite fast. When it lasts only a few seconds, ventricular tachycardia may cause no problems. But when sustained, ventricular tachycardia can lower theblood pressure, resulting in syncope (fainting) or lightheadedness. Ventricular tachycardia can also lead to ventricular fibrillation (a life-threatening arrhythmia) and cardiac arrest. For example, FIG. 5A illustrates heart with a normal sinus rhythm 500 and FIG. 5B illustrates a heart with ventricular tachycardia 520, according to implementations of the present disclosure.

[0055] VT results when an island of myocardium within either ventricle develops autonomous electrical activity (automaticity). This means that the abnormal tissue initiates beating out of sequence with the normal heartbeat. This can seriously limit cardiac output which results in lower blood pressure, poor organ perfusion, and most importantly can degenerate into ventricular fibrillation which is fatal within 3-4 minutes if not terminated.

[0056] VT can be treated with AADs, ICD implant, or VT ablation. AADs are often ineffective and have serious side effects including causing other cardiac arrhythmias, heart attack, lung damage, and death. ICDs can terminate VT but success is determined by prompt and accurate diagnosis of the VT event. Inappropriate ICD shocks, shocks administered for a non-VT arrhythmia, are a serious clinical problem. VT ablation is dependent on correctly localizing the abnormal tissues within the heart that result in VT.

[0057] Lethal cardiac rhythm disturbances (arrhythmias) can emanate from the right or left ventricle and may not be supraventricular in origin. Ventricular arrhythmias can be single abnormal beats (e.g., premature ventricular contractions ("PVCs")), groups of several beats in succession (e.g., more than three is designated ventricular tachycardia ("VT")), and / or such rapid and chaotic ventricular beating that the heart cannot effectively contract (e.g., Ventricular Fibrillation). Such conditions can be life threatening, for example death can result from Ventricular Fibrillation in 3-4 minutes. Antiarrhythmic drugs ("AADs") work by suppressing all excitable cardiac tissues in the hope of suppressing such arrhythmias. Such drugs often have life-threatening side effects, are poorly tolerated, and / or have a low therapeutic to toxic ratio.Because of this, treatments other than antiarrhythmic drugs are often used. Such treatments include automatic cardio defibrillators ("ICDs") that must be implanted, and / or ablation that destroys the source of the fibrillation.

[0058] A common form of treatment for VT is ventricular tachycardia ablation. VT ablation uses cold or heat energy to create tiny scars in the heart to block faulty signals that cause a rapid, erratic heartbeat. Ablation is also a known treatment for PVC. Ablation, including PVC and VT ablations can be difficult to perform and / or unsuccessful due to difficulty locating the arrhythmia. For example, it is not uncommon for the arrhythmia to be so intermittent that it is not detected at the time of ablation. Such ablations are invasive procedures that can last for less than 1 to several hours, but certainly not days. Thus, the arrhythmia for ablation may not be present or detectable at the time of ablation and localization for ablation is impossible. Another reason that ablation procedures can fail is that even if procedures are used during the ablation to irritate the cardiac electrical system, such as giving intravenous adrenalin or directly stimulating the heart, it can not be certain that any evoked arrhythmia is the same rhythm disturbance that the patient has been experiencing.

[0059] Collecting sufficient samples of the arrhythmia prior to an ICD implant or ablation procedure can be useful to make the correct diagnosis (e.g., determine if the arrhythmia worthy of a treatment procedure,) and / or to properly localize it within the heart to know where to ablate. This problem can be complicated by the fact that not all arrhythmias are associated with symptoms. A potentially fatal arrhythmia can occur in sub-lethal amounts very intermittently and be predominantly asymptomatic.

[0060] To identify and attempt to anatomically localize a possible culprit arrhythmia, outpatient cardiac arrhythmia collection methods are used to sample the cardiac rhythm for a predetermined time or triggered to record when a patient suffers symptoms that seem to thepatient to be cardiac related (e.g., palpitations, chest pain) and / or symptoms occur that can be cardiac related (e.g., dizziness, fainting). These methods can be categorized into two groups including prescriptive methods and non-prescriptive methods.

[0061] Example Prescriptive methods include: (1) Holter monitors; (2) Event monitors; and (3) Implantable loop recorders. Example non-prescriptive methods include: (1) Smartwatches; and discrete devices.

[0062] Briefly, devices implementing older methods available using a recording box and wired ECG leads are worn for up to three weeks. The wired recording boxes can't be worn while bathing, inhibit activities of daily living and sleeping. Both the chip methods and older- style recorders suffer from measurement drop out and noise that can render up to 50% of the cardiac complexes sampled uninterpretable. Indeed, such noise can be misinterpreted as an arrhythmia. Atrial fibrillation and other supraventricular rhythms can be miscategorized as VT.

[0063] A cardiac event monitor is typically a small piece of equipment that records heart rate and heart rhythm. These devices often collect the same information as an electrocardiogram (ECG), but are smaller and have a battery life of up to one month. There are several types of cardiac event monitors:

[0064] (1) Patch recorder: records for on average two weeks and the inclusive unit is worn as a patch on the chest wall;

[0065] (2) Symptom event monitor: Similar, but the device is turned on when symptoms occur; and

[0066] (3) Loop memory monitor: The device is activated during symptoms and can display the record ECG a minute or two before and after symptoms are perceived.

[0067] (4) Implanted loop recorders: Have an average cost of $5500 per unit. An implantable loop recorder, also known as an insertable cardiac monitor, is a small device that isimplanted under the skin of the chest for cardiac monitoring to record the heart's electrical activity for an extended period - for example, up to one year or more.

[0068] These existing systems can have disadvantages including: (A) Recording occurs for a maximum of three weeks, suffers from significant signal noise and drop out resulting in reduced sensitivity and specificity for important arrhythmias. Older style wired Holter monitors can be uncomfortable and inconvenient to wear for more than 48 hours. (B) In addition to signal noise and drop out, most cardiac arrhythmias are asymptomatic. (C) Such monitors are invasive, high cost, and limited by a very limited sensing vector that, besides increasing the chance of mis-categorization of ECG morphology, reduces the chance of localizing the anatomic location that is triggering the arrythmia.

[0069] Anatomic Localization of VT for Ablation

[0070] The surface 12-lead ECG is also a useful tool for the localization of VT site of origin. An ECG interpretation algorithm is most often used to localize the site of idiopathic VT using the bundle branch block pattern, precordial "R"- wave transition, and ECG characteristics of leads I and V1 / V6. Despite some inherent limitations including complex anatomy, the 12-lead ECG remains an indispensable tool for selecting the adequate ablation procedure method in order to save the time and improve ablation success of VT.

[0071] The surface electrocardiogram (ECG) is a useful tool to help identify the sites of origin of ventricular tachycardia (VT). Despite such limitations as chest wall deformity and metabolic and drug effects, the analysis of the QRS morphologic patterns and vectors can discern the site of activation of myocardium. There are numerous reports about ECG features of idiopathic left- and right-ventricular VT. There have also been summary reports of typical ECG characteristics according to the VT sites of origin based on previous reports, withanatomical considerations of the left and right ventricles, including the outflow tracts and epicardium.

[0072] In one aspect, the present disclosure is directed to a wearable electrocardiogram monitor devices, and methods of operating and / or implementing same, having anatomic localization for ventricular tachycardia detection and / or treatment (e.g., ablation) thereof. In another aspect, the present disclosure is directed to a closed loop system, having a wearable electrocardiogram monitor device, ventricular tachycardia detection and, in some implementations, upon detection, treatment (e.g., ablation) thereof.

[0073] In one aspect, the present disclosure is are directed to a wearable electrocardiogram monitor devices, and methods of operating and / or implementing same, having anatomic localization for ventricular tachycardia detection and / or treatment (e.g., ablation) thereof. In another aspect, the present disclosure is directed to a closed loop system, having a wearable electrocardiogram monitor device, ventricular tachycardia detection and, in some implementations, upon detection, treatment (e.g., ablation) thereof. The wearable electrocardiogram monitor devices of the present disclosure, and closed loop systems implementing same, can improve anatomic localization for ventricular tachycardia ablation procedures and, in addition thereto, or in lieu thereof, can reduce, minimize and / or eliminate erroneous ventricular tachycardia detections and subsequent erroneous and / or unnecessary cardio defibrillator treatment (e.g., current shock(s)).

[0074] The wearable electrocardiogram monitor devices of the present disclosure can improve anatomic localization for ventricular tachycardia (VT) ablation procedures. In addition thereto, or in lieu thereof, such wearable electrocardiogram monitor devices can reduce, minimize and / or eliminate erroneous or inappropriate ICD treatment (e.g., current shock(s)).

[0075] The methods described herein can reduce or eliminate erroneous cardiac defibrillator shocks for the single diagnosis of ventricular tachycardia. More broadly, however, implementations of the present disclosure method can be applied to other arrhythmias, with or without the involvement of any defibrillation with or without a "closed loop," control scheme for purposes of diagnosis, treatment, both, or neither, or treatment with any other kind of closed loop therapy, drug or device.

[0076] Any advantages of this system can be diagnostic for other arrhythmias than ventricular tachycardia, including requiring a smaller sample size to collect enough beats to make an accurate diagnosis. For example, this is true for atrial fibrillation.

[0077] With reference to FIG. 6, an example method of performing wearable cardiac monitoring is shown according to implementations of the present disclosure.

[0078] At step 610, the method includes positioning ECG electrodes on a patient. Optionally, the ECG electrodes are wireless ECG electrodes. Any number of electrodes can be used in various implementations of the present disclosure. In some implementations, the electrodes are placed on a limb or limbs of the patient (e.g., the arms and / or legs of a patient). Description of example configurations of ECG electrodes (also referred to herein as "ECG leads") is provided with reference to FIGS. 1A-4D).

[0079] At step 620, the method includes calibrating the plurality of wireless ECG electrodes. Optionally, calibrating the plurality of wireless ECG electrodes includes optimizing the detection of P-waves by configuring the position of the plurality of wireless ECG electrodes on the patient.

[0080] At step 630, the method includes receiving, from the plurality of wireless ECG electrodes, a cardiac measurement.

[0081] At step 640, the method includes receiving, from an ICD, an ICD measurement.

[0082] At step 650, the method includes determining, based on the ICD measurement and the cardiac measurement, the presence or absence of an arrhythmia. In some implementations, step 650 can further include estimating the location of the arrhythmia in the hearth.

[0083] In some implementations, the method can further include delivering a defibrillator (e.g., ICD) shock based on the presence or absence of an arrhythmia.

[0084] It should be understood that, in some implementations of the present disclosure, the method of FIG. 6 can be performed using different types of defibrillators (e.g., ACDs) instead of, or in addition to, the ICD described in FIG. 6.

[0085] FIG. 7 illustrates an example method 700 of performing wearable cardiac monitoring and VT treatment, according to implementations of the present disclosure.

[0086] As shown in FIG. 7, the method can be implemented as a closed loop where steps are repeated any number of times based on whether the patient is detected to be suffering VT after one or more treatments (e.g., shocks) with an defibrillator (e.g., the ACD / ICD described herein).

[0087] At step 702, the defibrillator circuit of the defibrillator is recharged.Optionally, at step 704, the signal from a defibrillator shock is detected / measured. As shown in FIG. 7, steps 702 and 704 can be optionally completed in parallel (e.g., at least partially at the same time). At step 706, signals from wearable ECG sensors and / or the defibrillator are acquired and analyzed. At step 708, the method includes determining whether the signals acquired at step 706 indicate the presence of a treatable cardiac disease (e.g., VT). If the signals acquired at step 706 indicate the presence of a disease e.g., VT) then the method can includedelivering a shock at step 710. Optionally, step 708 can further include receiving information about shock history, indications of heart damage or cardiac cell death, bio impedance and / or cardiac output, which can be used as additional criterial in any combination with VT and duration criteria described herein. Additional description of these parameters is provided with reference to the Example below.

[0088] If the signals acquired at step 706 do not indicate the presence of a treatable cardiac disease, then steps 706 and 708 can be repeated until the signals acquired at step 706 indicate the presence of a treatable cardiac disease (e.g., a cardiac disease that can be treated with a defibrillator shock like VT).

[0089] Additionally, as shown in FIG. 7, the shock delivered at step 708 can be based at least in part on stored values 712 of numbers of shocks delivered (e.g., in previous iterations of the method), intervals between multiple shocks delivered, and / or the number of joule per shock delivered. Optionally, information about the shock can be stored and used as inputs to step 708 in future iterations of the method 700.

[0090] In some implementations of the present disclosure, the method 700 shown in FIG. 7 can further include localizing the arrhythmia. For example, step 706 can include analyzing ECG signals and ICD signals from different locations around the body of a patient, to estimate a location of the arrhythmia. Optionally, the shock delivered at step 710 can be based in part on the estimated location of the arrhythmia.

[0091] FIG. 8 illustrates a system block diagram of a system 800 that can be used to implement the methods of FIG. 6 and 7. The system 800 can include any number of electrodes 802 (e.g., the wearable electrodes described herein with reference to FIGS. 1A-4D). The electrodes 802 can be disposed on any location of a patient's body, as also described with reference to FIGS. 1A-4D. The electrodes 802 collect ECG signals that are passed to a controller804. The controller 804 can include any / all components of the computing device 900 described with reference to FIG. 9. Optionally, the controller 804 includes an ECG device 801 configured to process the signals from the electrodes 802 into an ECG signal. Alternatively or additionally, an ICD 803 can be operably coupled to the controller 804 so that measurements from the ICD 803 can be used by the controller. Non-limiting example measurements from the ICD 803 include 02 measurements and any / all of the biochemical measurements described herein, for example with reference to the Example below. The controller 804 can optionally be an ECG base station, wearable electrocardiogram monitor device, and / or mobile device, as described with reference to FIGS. 1A-4D. The controller 804 can be configured to implement an algorithm 805 that determines whether to perform a shock based on ICD / ECG measurements and / or any of the other sensor measurement described herein. ECG / ICD measurements can be used in combination to determine if the arrythmia is VT or SVT, where VT indicates a shock can be administered and SVT indicates that a shock should not be administered. If VT is detected, optionally the shock is only administered if it lasts a predetermined time period and / or the pattern is a ventricular fibrillation pattern (VF). Optionally, the shock is limited so that shocks are not performed within a certain period of time of each other. Optionally, the energy of the shock used and / or the predetermined duration between shocks can be based on the level of cardiac output and / or cardiac cell injury / cell death.

[0092] For example, the algorithm 805 can include the method 700 shown and described with reference to FIG. 7. Alternatively or additionally, the algorithm 805 can include the steps illustrated in FIG. 10. Optionally, the controller 804 can further implement a duration filter 808 (e.g., a parametric duration filter) as part of detecting the arrythmia, as shown in FIG.8.

[0093] The controller 804 can determine an output 810 based on the detected arrythmia and / or determination of VT / SVT. The output 810 can optionally include a shock decision and / or a control signal configured to cause the ICD 803 to perform a shock.

[0094] The present disclosure contemplates that the electrodes and controller used in the methods of FIGS. 6 and 7 (and shown as electrodes 802 and controller 804 in the system 800 of FIG. 8) can be configured in a wide range of different configurations. FIGS. 1A-4C show non-limiting example configurations of electrodes that can be used with the systems and methods of FIGS. 6-8.

[0095] Referring now to Figures 1A, an example system 100 for detecting a cardiac arrythmia is shown. The system 100 can include two or more ECG leads 104 (e.g., wireless type leads), for example, 2, 3, 4, 5, 6, 7 8, 9, 10, 11 or 12 leads, including chest ECG leads, that, in some implementations, are comfortably and / or continuously wearable by the user / patient (e.g., 24 hours, 7 days per week (24 / 7) or substantially 24 / 7). Any number of ECG leads 104 can be configured as one or more arrays of ECG leads 102.

[0096] The ECG leads 104 can detect ECG related signals and transmit the signals (e.g., by wireless or wired connections) to a mobile device 162. The mobile device 162 can optionally correct the signals for latency and synchronicity as part of a calibration process (for example, using the calibration processes described herein). In this way, the ECG related signals output by the ECG leads 104 can be temporally correlated and synchronized. Moreover, in some implementations, the ECG related signals output by the ECG leads 104 are further compensated for noise (e.g., reduction or elimination via hardware or software) prior to transmission by the ECG lead 104 or after receipt of such signals by "downstream" circuitry.

[0097] In operation, the ECG leads 104 can be configured to communicate / transmit(e.g., wirelessly such as, e.g., Bluetooth (e.g., low energy Bluetooth)) the ECG related signal toother circuitry of the wearable electrocardiogram monitor device, as shown in Figures 1A-1D and 2A-2C). In some implementations, the transmission latency (e.g., latency of signal transmission / output by the ECG leads to signal acquisition by the circuitry of the wearable electrocardiogram monitor device) is less than or equal to 10 msecs.

[0098] It should be understood that the ECG leads 104 can be coupled in different combinations. As shown in FIG. 1A, ECG leads 104 can be coupled to one another (e.g., allowing transmission of ECG signals) and one or more of the ECG leads can be coupled to an ECG lead base station 108. The ECG lead base station 108 can optionally include any or all of the features of the computing device 900 shown in FIG. 9. For example, the ECG lead base station 108 can be configured to implement any or all of the features of the controller 804 described herein with reference to FIG. 8.

[0099] In some implementations of the present disclosure, multiple ECG lead base stations 108 are used, as shown in the system 120 of FIG. IB. It should be understood that any number of ECG lead base stations can be linked to any number of ECG leads 104 using any number of communication links 106.

[0100] In some implementations, an ECG lead 104 is configured to serve as the ECG lead base Station 108 for the signals detected by other ECG leads 104 or arrays of ECG leads 102.

[0101] As shown in the system 140 of FIG. 1C, the ECG lead base stations 108 can optionally be configured to communicate between each other by communication links 142.

[0102] As yet another example, as shown by the system 160 of FIG. ID, multiple ECG leads 104 can use multiple communication links 106 to the same mobile device 162.

[0103] The devices shown in FIGS. 1A-4C can communicate via communication links (variously illustrated as 106, 202, 404, 422, or 404) that can be wired or wireless includingbut not limited to wired connections such as ethernet, wireless connections, Bluetooth, Wi-Fi, a low-energy transmission such as Bluetooth or Near Field Communication, mobile connections to mobile networks, or other networks including Local Area Networks and the internet, or any combination thereof. The communication links can optionally be implemented using one or more computing devices 900 as illustrated in FIG. 9, for example using the network connections 916 described with reference to FIG. 9.

[0104] As shown in FIG. 2A-2C optionally the array of ECG leads 102 can include a single communication link 202 with the mobile device 162. For example, the system 200 of FIG. 2A can include a communication link 202 between the array of ECG leads 102 and the mobile device 162, where the array of ECG leads include an ECG lead base station 108. As shown in the system 230 of FIG. 2B, the array of ECG leads 102 can include any number of ECG leads 104 and ECG lead base stations 108. And, as yet another example, the array of ECG leads 102 can include communication links 202 between the ECG lead base stations 108, as shown in the system 260 of FIG. 2C.

[0105] As shown in FIGS. 3A-3C, implementations of the present disclosure include systems configured to work with a defibrillator. As shown in the system 300 of FIG. 3A, an example ICD unit 302 is coupled to the wearable electrocardiogram monitor device 304 using a communication link 202. The ECG lead base station 108 can be in communication with both the ECG leads 104 and ICD unit 302 so that information from the ECG lead base station 108 and ICD unit 302 can be exchanged. Either the ECG lead base station 108 and / or ICD unit 302 can operate as a controller to determine when to administer an electric shock based on the signals measured by the ECG leads 104 and ICD unit 302. Additional description of example systems and methods for determining when to operate a defibrillator using ECG and ICD signals is provided with reference to FIGS. 6-8.

[0106] As shown in the system 330 of FIG. 3B, any number of ECG lead base stations 108 can be included and in operable communication with the ICD unit 302.

[0107] As shown in the system 360 of FIG. 3C, the array of ECG leads 102 can be part of a wearable electrocardiogram monitor device 304. As described herein, implementations of the present disclosure include ECG leads 104 that are configured for longterm wear and / or can be operably coupled to mobile devices 162 (e.g., cell phones, computers, or any other computing device). The wearable electrocardiogram monitor device 304 can be in communication with the ICD unit 302 by a communication link 202 so that the mobile device 162 can operate as a controller, either alone or in combination with the ICD unit 302.

[0108] The electrocardiogram signals can be transmitted / provided to, for example, a processor or state machine (e.g., implemented using the computing device 900 of FIG. 9) of the wearable electrocardiogram monitor device 304, via the ECG leads 104. In some implementations, the wearable electrocardiogram monitor device 304 includes a memory with instructions that cause a processor of the wearable electrocardiogram monitor device 304 to remove artifacts from the ECG related signals. Alternatively or additionally, the processor can compensate for body motion of the user / patient. In this way, the wearable device, in some implementations, generates "clean" waveforms, for example, at least 95% of the time of detection as well as a lower limit of time to detection - thereby providing a 95% confidence limit of six complexes in succession.

[0109] In some implementations, the ECG leads 104 of the wearable electrocardiogram monitor device 304 each include a battery power source, for example, a rechargeable battery power source (e.g., having a battery life, without recharging, of 24 hours or more). Here, the battery power source can power the detection and transmission circuitry in the ECG lead 104. Moreover, in certain implementations, the ECG lead 104 also includes dataprocessing circuitry (e.g., a processor or state machine) to process the ECG related data, for example, implement noise reduction techniques where, in some implementations, the power source is employed to further power such circuitry.

[0110] With reference to FIGS. 4A-4C, implementations of the present disclosure can further include a database402 operably coupled to any or all of the devices disclosed herein using one or more communication links. As shown in the system 400 of FIG. 4A, the database 402 can be in operable communication with the mobile device 162 by a communication link 404. Alternatively or additionally, as shown in the system 420 of FIG. 4B, the database can be in operable communication with the ICD unit 302 by a communication link 424 and with the mobile device 162 by a communication link 404. As yet another example, as shown in the system 440 of FIG. 4C, the defibrillator can be an ACD unit 442 and the database 402 can be in communication with the ACD unit 442 by a communication link 424, the ACD unit 442 can be coupled to the wearable electrocardiogram monitor device 304 by a communication link 202, and the database 402 can be coupled to the wearable electrocardiogram monitor device 304 by a communication link 444. As still another example, in the system 460 of FIG. 4D, the ACD unit 442 is coupled to the database 402 by a communication link 424 and to the wearable electrocardiogram monitor device 304 by a communication link 202. A mobile device 162 is coupled to the database 402 by a communication link 403, and to the wearable electrocardiogram monitor device 304 by a communication link 202.

[0111] For example, mobile device 162 can communicate with database 402 via communication link 404, where communication link 404 can be facilitated by WiFi from the mobile device 162, to a wireless router connected to the Internet, to a wired internet connection connecting to database 402.

[0112] A calibration process, or portions thereof, (e.g., as described herein) can be stored in and executed from an associated portable / wearable electronic device (e.g., a mobile phone and / or physical activity monitoring device) which, in combination with the ECG leads 104, can be the wearable electrocardiogram monitor device 304 as shown in FIGS. ID and 2A-2C. In some implementations, the calibration process, or portions thereof, can be stored in and executed from one or more ECG lead base stations 108 shown in FIGS. 1A-1C.

[0113] The calibration process, in some implementations, can include a feature that, after start-up, initially facilitates optimizing the detection of P waves of the ECG signals to enhance atrial fibrillation (AF) detection and reduce and / or eliminate episodes of AF as a cause of inappropriate ICD shocks. In some implementations, this is implemented by locating and fixing the ECG electrodes (e.g., wireless type) on one or more limbs of the user / patient or via a wireless ECG patch that is disposed on the chest to optimize P wave detection. Here, the optimization feature of the calibration process can instruct and / or assist the user to position and secure the wireless ECG electrodes on one or more of the user's limbs and / or by placing and securing an ECG patch (e.g., wireless type) on the user's chest to improve or optimize P wave detection. In this way, the detection of the ECG P waves by the portable / wearable electronic device can be enhanced or improved which, in turn, enhances AF detection and reduces or eliminates episodes of AF as a cause of inappropriate or unnecessary treatment (e.g., ICD shocks).

[0114] In some implementations, the method calibration processes described herein can be further enhanced via implementing Machine Learning in the wearable electrocardiogram monitor device to more accurately detect the P wave of the ECG signals.

[0115] The wearable electrocardiogram monitor device 304, in some implementations, can include a feature (for example, a button which can be implemented viahardware or software (via, e.g., a touchscreen display)) whereby the user / patient can"manually" inform or notify the wearable electrocardiogram monitor device, or a remote monitoring system thereof, that a symptomatic event has occurred and to describe the type of event, such as dizziness, chest pain, fainting, palpitations, etc. In response, the wearable electrocardiogram monitor device, for example, can store the event information (which can include date and time-stamped information) and, in addition thereto or in lieu thereof, transmit (e.g., wirelessly) such information to a remote server for further analysis and notification to caregivers.

[0116] In some implementations, the wearable electrocardiogram monitor device 304 (e.g., one or more of the ECG leads 104 and / or one or more ECG lead base stations 108) can include additional biosensors to collect additional biological data of the user / patient. The wearable electrocardiogram monitor device can employ such data to more fully characterize any clinical event, symptomatic or not. For example, the additional biosensors can include one or more, or all of:1. PPG-derived blood pressure;2. Pulse oximetry;3. Fluid monitoring via bioimpedance;4. Autonomic Nervous System Output via non-invasive systems; and / or5. Blood glucose by the method of bioimpedance.

[0117] Data provided from such additional biosensors can improve the clinical utility of VT detection. For instance, if the patient is complaining of dizziness and the VT detected is also noted to lower blood pressure, it would be more likely that the detected VT is the source of dizziness.

[0118] The wearable electrocardiogram monitor device 304, in some implementations, includes or implements a process, having a set of rules, to determine the presence and / or location of VT anatomically. Optionally, the set of rules can be developed fromor based on clean multi-spatial (multiple lead) ECG morphology available in the public domain representing a consensus of electrocardiographers. Indeed, changes in VT location suggesting more than one locus or the development of a new site of VT likely aids in determining the characteristics, method and / or type of treatment.

[0119] In operation, the wearable electrocardiogram monitor device can be employed to treat or address, and / or assist in the treatment of VT being experienced by the user / patient, for example, enhance VT ablation of the user / patient. For example, in some implementations, the user / patient optimizes the ECG electrode array using one or more of the configurations or techniques described above. Thereafter, the wearable electrocardiogram monitor device acquires ECG data - for example, until a high confidence level for anatomic localization of any VT locus is attained (e.g., greater than 90%, and preferably, 95% confidence level). After attaining or providing a high confidence level for anatomic localization of any VT locus, the process or technique applies the rules described in herein, to anatomically localize the source of the detected VT. This operation can be suitable forthose users / patients that include one or more of the following:1. Suspicious symptoms suggesting possible ventricular arrhythmias appropriate for ablation, such as unexplained syncope; and / or2. Prior ECG demonstration via surface ECG or other ECG monitor suggesting the possibility of sustained VT such as frequent PVCs; and / or3. A high-risk state such as the presence of a ventricular aneurysm from prior myocardial infarction, severe heart failure, prior sudden death episode, etc.

[0120] In some implementations, the wearable / portable electrocardiogram monitor devices of the present disclosure can be incorporated into a closed loop system (e.g., monitoring in real-time), according to one or more implementations of the present disclosure, includes the following components, structures, characteristics, and / or functionality:

[0121] Optional ly, two or more ECG leads 104 (e.g., wireless type leads), for example, 2, 3, 4, 5, 6, 7 8, 9, 10, 11 or 12 leads, including chest ECG leads 104, that, in some implementations, are comfortably and continuously wearable by the user / patient (e.g., 24 hours, 7 days per week (24 / 7) or substantially 24 / 7). The ECG leads 104 can be configured as an array of ECG leads 102. (See, e.g., Figures 3A-3C and 4B-4D).

[0122] Alternatively or additionally, the ECG leads 104 detect ECG related signals wherein such signals are corrected for latency and synchronicity as part of a calibration process. In this way, the ECG related signals output by the ECG leads are temporally correlated and synchronized. Moreover, in some implementations, the ECG related signals output by the ECG leads are further compensated for noise (e.g., reduction or elimination via hardware or software) prior to transmission by the ECG lead or after receipt of such signals by "downstream" circuitry.

[0123] Alternatively or additionally, the ECG leads are configured to communicate / transmit (e.g., wirelessly such as, e.g., Bluetooth (e.g., low energy Bluetooth)) the ECG related signals to other circuitry of the wearable electrocardiogram monitor device. (See, e.g., Figures 3A-3C and 4B-4D). In some implementations, the transmission latency (e.g., latency of signal transmission / output by the ECG leads to signal acquisition by the circuitry of the wearable electrocardiogram monitor device) is less than or equal to 10 msecs.

[0124] The present disclosure contemplates different form factors and configurations of ECG lead base station 108. For example a ECG lead base station 108can optionally be a portable and / or wearable electronic device (e.g., mobile computing device such as a smartwatch and / or mobile phone). Alternatively or additionally, the ECG lead base station 108 can be a wearable device used in lieu of one or more ECG leads as described with reference to FIGS. ID, 2A-2C and 3C, for example. The present disclosure contemplates thatconfigurations of base station(s) can be used, whether implementing base station leads or not and / or portable / wearable electronic device (e.g., personal device such as a smartwatch and / or mobile phone).

[0125] Alternatively or additionally, one ECG lead can be configured to serve as a "base station ECG lead" for the signals detected by the ECG leads (e.g., array of two or more leads), as shown in FIG. 3A for example. As used herein, a base station ECG lead refers to an ECG lead that includes a computing device (e.g., any or all parts of the computing device 900 shown in FIG. 9) configured so that the ECG can both measure ECG signals and serve as an ECG lead base station.

[0126] The base station ECG lead can perform any or all of the functions of the ECG lead base station 108 described herein. For example, the base station ECG lead can receive and process the output from a plurality of the ECG leads 104 (e.g., all the ECG leads 104) to associated circuitry (which can optionally be a part of the wearable electrocardiogram monitor device 304 (e.g., a dedicated electrocardiogram monitor device (e.g., wearable) or any mobile device 162 such as a portable and / or wearable device (e.g., personal device such as a smartwatch and / or mobile phone)). The wearable electrocardiogram monitor device 304 can, in some implementations, be any portable electrocardiogram monitor device as shown in FIG. 2A, for example. In some implementations, a plurality of the ECG leads can function as "base station" ECG leads (e.g., where each base station ECG lead functions as a base station for those leads that are associated therewith), as shown in FIGS. IB and 1C. One or more (or all) of base station ECG leads can be configured to individually and / or synchronously (relative to the other base station ECG leads) communicate with, via transmitting the ECG signals, other circuitry of a wearable electrocardiogram monitor device as shown in FIGS. 2B and 2C. In some implementations, the ECG leads 104 are configured to separately and / or independentlycommunicate with a mobile device 162 (e.g., a wearable or portable electronic device), such as a smartwatch or cellphone, where each ECG lead 104 detects, processes, and outputs the associated ECG data to associated circuitry of the wearable electrocardiogram monitor device as shown in FIG. ID.

[0127] The base station ECG lead can receive and process the output from a plurality of the ECG leads (e.g., all the ECG leads) to associated circuitry of the wearable electrocardiogram monitor device (which can optionally be a dedicated electrocardiogram monitor device (e.g., wearable) or any portable and / or wearable electronic device (e.g., personal device such as a smartwatch and / or mobile phone) as shown in FIG. 3C, for example. In some implementations, more than one of the ECG leads can function as "base station" leads (e.g., where each base station ECG lead functions as a base station for one or more associated ECG leads as shown in FIG. 3B. Here, one or more (or all) of base station ECG leads can be configured to individually and / or synchronously (relative to the other base station ECG leads) communicate with, via transmitting the ECG signals, other circuitry of the wearable electrocardiogram monitor device, as shown in FIGS. 3A-3C. In some implementations, all of the ECG leads are configured to separately and / or independently communicate with the wearable or portable electronic device, such as a smartwatch or cellphone, whereby each ECG lead detects, processes, and outputs the associated ECG data to associated circuitry of the wearable electrocardiogram monitor device as shown in FIG. 3C. In some implementations, all of the functionality and circuitry described herein can be incorporated in one or more base station ECG leads.

[0128] Alternatively or additionally, the electrocardiogram signals can be transmitted / provided to, for example, a processor or state machine of the wearable monitor device via the ECG leads. In some implementations, a processor, implementing suitablesoftware, removes artifacts from the ECG related signals. In addition thereto, or in lieu thereof, the processor can compensate for body motion of the user / patient. In this way, the wearable device, in some implementations, generates "clean" waveforms, for example, at least 95% of the time of detection as well as a lower limit of time to detection - thereby providing a 95% confidence limit of six complexes in succession.

[0129] Alternatively or additionally, in some implementations, the ECG leads of the wearable electrocardiogram monitor device each include a battery power source, for example, a rechargeable battery power source (e.g., having a battery life, without recharging, of 24 hours or more). Here, the battery power source can power the detection and transmission circuitry in the ECG lead. Moreover, in certain implementations, the ECG lead also includes data processing circuitry (e.g., a processor or state machine) to process the ECG related data, for example, implement noise reduction techniques where, in some implementations, the power source is employed to further power such circuitry.

[0130] Alternatively or additionally, in some implementations, the "base station" can be a portable and / or wearable electronic device (e.g., personal device such as a smartwatch and / or mobile phone)) - in addition to, or in lieu of one or more ECG leads (e.g., FIG. 3C).

[0131] Alternatively or additionally , the calibration process, or portions thereof, can be stored in and executed from an associated implantable device (e.g., the ICD 803 shown in FIG. 8), or an mobile device 162 (e.g., a portable / wearable electronic device such as a mobile phone and / or physical activity monitoring device) which, in combination with the ECG leads, can be the wearable electrocardiogram monitor device shown in FIGS. 3A-3C. In some implementations, the calibration process, or portions thereof, can be stored in and executed from one or more base station ECG leads (e.g., the ECG lead base station 108 shown in FIGS.4A-4D). In some implementations, the portable / wearable electronic device communicates wirelessly and securely with the ICD to supply ECG information for detection of VT as described with reference to FIGS. 3A-3C and 4B-4D).

[0132] Alternatively or additionally, the calibration process, can include a feature that, after start-up, initially facilitates optimizing the detection of P waves of the ECG signals to enhance AF detection and reduce and / or eliminate episodes of AF as a cause of inappropriate ICD shocks. In some implementations, this is implemented by locating and fixing the ECG electrodes (e.g., wireless type) on one or more limbs of the user / patient or via a wireless ECG patch that is disposed on the chest to optimize P wave detection. Here, the optimization feature of the calibration process can instruct and / or assist the user to position and secure the wireless ECG electrodes on one or more of the user's limbs and / or by placing and securing an ECG patch (e.g., wireless type) on the user's chest to improve or optimize P wave detection. In this way, the detection of the ECG P waves by the portable / wearable electronic device can be enhanced or improved which, in turn, enhances AF detection and reduces or eliminates episodes of AF as a cause of inappropriate or unnecessary treatment (e.g., ICD shocks).

[0133] Alternatively or additionally, in some implementations, the methods and calibration processes of can be further enhanced via implementing Machine Learning in the wearable electrocardiogram monitor device to more accurately detect the P wave of the ECG signals.

[0134] Alternatively or additionally, in some implementations, the portable / wearable electronic device is configured to receive ECG signals from an implantable device (e.g., ICD unit) and employ the diagnostic input available from the internal ECG sensorsof the ICD to improve and / or further augment ECG waveform analysis, (e.g., the ICD bidirectional transmission illustrated in Figures 3A-3C and 4B-4D).

[0135] In some implementations the wearable electrocardiogram monitor device can include a feature (for example, a button which can be implemented via hardware or software (via, e.g., a touchscreen display)) configured so that the user / patient can input an indication into the wearable electrocardiogram monitor device, and / or a remote monitoring system thereof, that a symptomatic event has occurred and to describe the type of event, such as dizziness, chest pain, fainting, palpitations, etc. In response, the wearable electrocardiogram monitor device, for example, can store the event information (e.g., including date and time- stamped information) and, in addition thereto or in lieu thereof, transmit (e.g., wirelessly) such information to a remote server for further analysis and notification to caregivers.

[0136] Alternatively or additionally, the wearable electrocardiogram monitor devices described herein (e.g., one or more of the ECG leads, one or more base station ECG leads and / or the portable / wearable electronic device) can include additional biosensors to collect additional biological data of the user / patient. The wearable electrocardiogram monitor device can employ such data to more fully characterize any clinical event, symptomatic or not. For example, the additional biosensors can include one or more, or all of: i. PPG-derived blood pressure; ii. Pulse oximetry; iii. Fluid monitoring via bioimpedance; iv. Autonomic Nervous System Output via non-invasive systems; and / or v. Blood glucose by the method of bioimpedance.

[0137] Any available biosensor that is in any way associated with the cardiovascular system could be a candidate. Data provided from such additional biosensors can improve the clinical utility of VT detection. For instance, if the patient is complaining ofdizziness and the VT detected is also noted to lower blood pressure, it can be more likely that the detected VT is the source of dizziness.

[0138] In some implementations, the wearable electrocardiogram monitor device includes and / or implements a process, having a set of rules, to determine the presence and / or location of VT anatomically. The set of rules can be developed from or based on clean multi-spatial (multiple lead) ECG morphology available in the public domain representing a consensus of electrocardiographers. Indeed, changes in VT location suggesting more than one locus or the development of a new site of VT likely aids in determining the characteristics, method and / or type of treatment.

[0139] Alternatively or additionally, the wearable electrocardiogram monitor device is configured to receive ECG signals from the ICD unit, the process implemented thereby can improve and / or augment VT detection and anatomic localization based thereon.

[0140] Alternatively or additionally, the closed loop system can be configured to suspend, decouple and / or disregard the input(s) and / or control signal(s) of the wearable device when it is determined that the closed loop system, for example, the wearable device, is inoperative (for example, due to circuit or software failure). Under this circumstance, the operability and functionality of the ICD is decoupled from the wearable electrocardiogram monitor device.

[0141] Alternatively or additionally, when the wearable ECG component is integrated with an ICD, can operate or function as a real-time closed loop system for enhanced or augmented ICD function.

[0142] In operation, the wearable electrocardiogram monitor device, in a closed loop system, can be employed to treat or address, and / or assist in the treatment of VT being experienced by the user / patient, for example, enhance VT ablation of the user / patient. Forexample, after an ICD unit is implanted in the user / patient, the user / patient optimizes the ECG electrode array using one or more of the configurations or techniques described herein. Thereafter, the wearable electrocardiogram monitor device acquires ECG data - for example, until a high confidence level for anatomic localization of any VT locus is attained (e.g., greater than 90%, and preferably, 95% confidence level). After attaining or providing a high confidence level for anatomic localization of any VT locus, the process or technique applies the rules described herein to anatomically localize the source of the detected VT.

[0143] When the system is configured (e.g., optimally configured) for VT detection without interface to the ICD, the ECG data available from the ICD's onboard ECG detection system can be provided to the wearable electrocardiogram monitor device. In this way, the initialization of the system is complete. Thereafter, there is much greater probability that any VT episode requiring treatment will be correctly and timely identified and appropriately treated. The probability of inappropriate ICD shocks will be reduced because of the greater accuracy of ECG detection and analysis provided by the addition of the wearable ECG system as described.

[0144] Example

[0145] With reference to FIGS. 7, 8, and 10, an example implementation includes a wearable device configured to operate with a defibrillator (e.g., ICD). The example implementation includes improved methods and systems for preventing unnecessary and / or ineffective defibrillator shocks. Unnecessary / ineffective shocks are very uncomfortable when delivered for the wrong diagnosis and can create a micro burden of heart cell death which is cumulative over time.

[0146] Existing methods and systems can fail to differentiate between supraventricular tachycardia, SVT, and ventricular tachycardia, VT. These two rhythms can lookvery much alike, leading to difficulty in differentiating them using existing systems. Many inappropriate ICD shocks are for SVT. Measuring or detecting atrial activity can allow the differentiation of SVT and VT. Measuring and detecting atrial activity may not be accurate using electrodes in an ICD, which is implanted near the heart. The example implementation of the present disclosure uses a remote electrode to overcome these challenges. By incorporating the electrode into a wearable electrocardiogram monitor device (e.g., smart band), the example implementation can include an ECG lead with a synchronous linkage and can greatly improve SVT vs VT determination. Additionally, the example implementation using an external ECG lead can implement closed-loop monitoring methods (e.g., as shown in FIG. 7) to monitor the SVT vs VT algorithm subroutine and significantly enhance p-wave detection, improving VT diagnosis.

[0147] Example wearable electrocardiogram monitor devices 304 that can be used to provide a remote electrode (e.g., ECG lead 104) are described herein with reference to FIG. 3A-4D, for example. Again, the wearable electrocardiogram monitor device 304 can further include at least one ECG lead 104 operably coupled to the mobile device 162, as described with reference to FIG. ID. Alternatively or additionally, the wearable electrocardiogram monitor device 304 can include an array of ECG leads 102 in operable communication with the mobile device 162, as shown in FIG. 3C. The wearable electrocardiogram monitor device 304 can be worn on a limb (e.g., an arm), so that an ECG lead 104 or array of ECG leads 102 can be in contact with the limb of the user. The wearable electrocardiogram monitor device 304 can further include the ECG lead base station(s) 108 described herein.

[0148] The wearable electrocardiogram monitor device 304 can be configured to implement the systems and methods described with reference to FIGS. 7 and 8. For example, the controller 804 shown in FIG. 8 can be part of the mobile device 162 and / or wearable electrocardiogram monitor device 304. Additionally, as described above, the mobile device 162and / or wearable electrocardiogram monitor device 304 can include any or all of the components of the computing device 900 shown in FIG. 9. In the example implementation, the algorithm 805 described with reference to FIG. 8 can optionally be the algorithm shown in FIG. 10.

[0149] Additionally, the example implementation can determine whether a VT should be shocked. Some cases of VT should not be shocked and can instead be treated by prescription or rest / waiting. As a non-limiting example, a VT of short duration (e.g., 1 hour) that does not cause a drop in blood pressure can be treated without requiring a shock. Optionally, a PPG signal can be an additional input to the algorithm 805. For example, in the method 700 of FIG. 7, step 708 can optionally include receiving a PPG signal. As yet another example, other sensors described herein can be used as inputs to the algorithm 805, and / or used at step 708 of the method 700. For example, measures of pulse oximetry, bio impedance, shock history, heart damage indicators, and cardiac output can all be used as additional inputs to step 708. Any combination of these measurements can be used as part of the determination at step 708 that VT is present and that a shock should be performed to treat the VT. If VT is not present, or the VT should not be treated with a shock (e.g., the short duration VT without loss of blood pressure described herein) then the determination made at step 708 can be to not perform the shock.

[0150] Additional example inputs to step 708 include whether the VT has lasted more than 10 seconds; whether systolic blood pressure has fallen below 90 and / or more than 20%; and / or has the pulse oximetry reading dropped below an oxygen saturation of 90%. As a non-limiting example, applying these parameters, if the condition is VT, it lasts more than 10 seconds, the systolic blood pressure has not fallen below 90 or more than 20%, and the pulseoximetry reading has dropped below an oxygen saturation of 90%, then a shock will be administered.

[0151] In some implementations, a VT that only lasts 5 seconds is too short to def ibri I late. Optionally, if the VT is recurrent or followed by brief episodes of ventricular fibrillation (VF) (the precursor of death) can require immediate intervention. Implementations of the present disclosure can transmit an indication that the VT and / SVT is not treatable, and / or that another condition is present (e.g., VF). For example, a computing device of at least one of the mobile device, ICD, and / or wearable electrocardiogram monitor device can transmit the can be configured to transmit the indication via a network (e.g., to a server or cloud computing system), which can in turn be used to dispatch assistance to the wearer.

[0152] Additionally, in the example implementation, the method 700 can include tracking the burden of cell death associated with ICD discharge. The method 700 can track and / or report the number of shocks, as well as any other indications of changes in heart function / anatomy recorded by sensors of the example system and / or ICD. Examples of indications of changes in heart function / anatomy that can be tracked using the systems and methods of the present disclosure include: the biomarker blood troponin, which is a marker of heart attack and the blood concentration of which is proportional to the amount of cell death; and bioimpedance, which can be measured by the wearable electrocardiogram monitor device 304. The bioimpedance can be used, alone or in combination with a PPG signal and / or bloodpressure derived from PPG, to measure cardiac output. Cardiac output can decline with repeated shocks.

[0153] Additional examples of indications of changes in heart function / anatomy that can be tracked using the systems and methods of the present disclosure include a progressive fall in blood pressure, which can indicate ICD-associated damage; a change an ECGsignal recorded at the skin's surface, for example by the wearable electrocardiogram monitor device 304; and a drop in blood pH (for example, towards acidosis).

[0154] References:

[0155] The following publications are hereby incorporated by reference in their entireties:

[0156] "Using the Surface Electrocardiogram to Localize the Origin of Idiopathic VentricularTachycardia" Kyoung-Min Park, M.D., Ph.D., et al.

[0157] "The Defibrillation Conundrum: New Insights into the Mechanisms of Shock-Related Myocardial Injury Sustained from a Life-Saving Therapy", Nicolas Clementy et al., Int J Mol Sci. 2021 May; 22(9): 5003; Published online 2021 May 8. doi: 10.3390 / ijms22095003; PMCID: PMC8125879 and PMID: 34066832

[0158] It should be appreciated that the logical operations described herein with respect to the various figures may be implemented (1) as a sequence of computer implemented acts or program modules (i.e., software) running on a computing device (e.g., the computing device described in FIG. 9), (2) as interconnected machine logic circuits or circuit modules (i.e., hardware) within the computing device and / or (3) a combination of software and hardware of the computing device. Thus, the logical operations discussed herein are not limited to any specific combination of hardware and software. The implementation is a matter of choice dependent on the performance and other requirements of the computing device. Accordingly, the logical operations described herein are referred to variously as operations, structural devices, acts, or modules. These operations, structural devices, acts and modules may be implemented in software, in firmware, in special purpose digital logic, and any combination thereof. It should also be appreciated that more or fewer operations may beperformed than shown in the figures and described herein. These operations may also be performed in a different order than those described herein.

[0159] As used herein, the term "circuitry", means, among other things, a circuit (whether integrated or otherwise), a group of such circuits, one or more processors, one or more state machines, one or more processors implementing software, one or more gate arrays, programmable gate arrays and / or field programmable gate arrays, or a combination of one or more circuits (whether integrated or otherwise), one or more state machines, one or more processors, one or more processors implementing software, one or more gate arrays, programmable gate arrays and / or field programmable gate arrays.

[0160] Referring to FIG. 9, an example computing device 900 upon which the methods described herein may be implemented is illustrated. It should be understood that the example computing device 900 is only one example of a suitable computing environment upon which the methods described herein may be implemented. Optionally, the computing device 900 can be a well-known computing system including, but not limited to, personal computers, servers, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, network personal computers (PCs), minicomputers, mainframe computers, embedded systems, and / or distributed computing environments including a plurality of any of the above systems or devices. Distributed computing environments enable remote computing devices, which are connected to a communication network or other data transmission medium, to perform various tasks. In the distributed computing environment, the program modules, applications, and other data may be stored on local and / or remote computer storage media.

[0161] In its most basic configuration, computing device 900 typically includes at least one processing unit 906 and system memory 904. Depending on the exact configuration and type of computing device, system memory 904 may be volatile (such as random accessmemory (RAM)), non-volatile (such as read-only memory (ROM), flash memory, etc.), or some combination of the two. This most basic configuration is illustrated in FIG. 9 by dashed line 902. The processing unit 906 may be a standard programmable processor that performs arithmetic and logic operations necessary for operation of the computing device 900. The computing device 900 may also include a bus or other communication mechanism for communicating information among various components of the computing device 900.

[0162] Computing device 900 may have additional features / functionality. For example, computing device 900 may include additional storage such as removable storage 908 and non-removable storage 910 including, but not limited to, magnetic or optical disks or tapes. Computing device 900 may also contain network connection(s) 916 that allow the device to communicate with other devices. Computing device 900 may also have input device(s) 914 such as a keyboard, mouse, touch screen, etc. Output device(s) 912 such as a display, speakers, printer, etc. may also be included. The additional devices may be connected to the bus in order to facilitate communication of data among the components of the computing device 900. All these devices are well known in the art and need not be discussed at length here.

[0163] The processing unit 906 may be configured to execute program code encoded in tangible, computer-readable media. Tangible, computer-readable media refers to any media that is capable of providing data that causes the computing device 900 (i.e., a machine) to operate in a particular fashion. Various computer-readable media may be utilized to provide instructions to the processing unit 906 for execution. Example tangible, computer- readable media may include, but is not limited to, volatile media, non-volatile media, removable media 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. System memory 904, removable storage 908, and non-removablestorage 910 are all examples of tangible, computer storage media. Example tangible, computer- readable recording media include, but are not limited to, an integrated circuit (e.g., field- programmable gate array or application-specific IC), a hard disk, an optical disk, a magnetooptical disk, a floppy disk, a magnetic tape, a holographic storage medium, a solid-state device, RAM, ROM, electrically erasable program read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices.

[0164] In an example implementation, the processing unit 906 may execute program code stored in the system memory 904. For example, the bus may carry data to the system memory 904, from which the processing unit 906 receives and executes instructions. The data received by the system memory 904 may optionally be stored on the removable storage 908 or the non-removable storage 910 before or after execution by the processing unit 906.

[0165] It should be understood that the various techniques described herein may be implemented in connection with hardware or software or, where appropriate, with a combination thereof. Thus, the methods and apparatuses of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, or any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computing device, the machine becomes an apparatus for practicing the presently disclosed subject matter. In the case of program code execution on programmable computers, the computing device generally includes a processor, a storage medium readable by the processor (including volatile and non-volatile memory and / or storage elements), at least one input device, and at least one output device. One or more programsmay implement or utilize the processes described in connection with the presently disclosed subject matter, e.g., through the use of an application programming interface (API), reusable controls, or the like. Such programs may be implemented in a high level procedural or object- oriented programming language to communicate with a computer system. However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language and it may be combined with hardware implementations.

Claims

WHAT IS CLAIMED:

1. A system comprising: a plurality of wearable ECG leads; a controller operably coupled to the plurality of wearable ECG leads, the controller comprising a processor and a memory with computer-readable instruction stored thereon, wherein execution of the computer-readable instruction by the controller causes the processor to: receive a plurality of ECG signals from the wearable ECG leads; and output, based on the ECG signals, a cardiac measurement.

2. The system of claim 1, wherein the system further comprises an implantable cardioverter defibrillator (ICD) operably coupled to the controller, wherein the ICD is configured to receive the cardiac measurement.

3. The system of claim 1, wherein the system further comprises an automatic cardioverter defibrillator (ACD), wherein the ACD is configured to receive the cardiac measurement.

4. The system of claim 2, wherein the ICD is further configured to deliver an ICD shock based at least in part on the cardiac measurement.

5. The system of claim 2 or claim 4, wherein the ICD is configured to transmit an ICD measurement to the controller, and wherein the cardiac measurement is based at least in part on the cardiac measurement.

6. The system of any one of claims 1-5, wherein the controller is further configured to synchronize the signals of the ECG leads.

7. The system of claim 6, wherein synchronizing the signals of the ECG leads comprises correcting the synchronicity of the ECG leads.

8. The system of claim 6, wherein synchronizing the signals of the ECG leads comprises correcting a latency of the ECG leads.

9. The system of any one of claims 1-8, wherein the plurality of ECG leads comprise a base station ECG lead, wherein the base station ECG lead comprises the controller.

10. The system of claim 9, further comprising a mobile computing device in operable communication with the base station ECG lead.

11. The system of claim 10, further comprising a remote computing device in operable communication with the base station ECG lead or the mobile computing device.

12. The system of any one of claims 1-9, further comprising at least one biosensor operably coupled to the controller, wherein the biosensor is configured to output a biosensor measurement.

13. The system of claim 12, wherein the biosensor comprises at least one of a PPG sensor, pulse oximetry sensor, or bioimpedance sensor.

14. The system of claim 12, wherein the biosensor measurement comprises at least one of a fluid monitoring measurement, autonomic nervous system output measurement, or PPG-derived blood pressure measurement blood pressure.

15. The system of claim 12, wherein the memory further comprises instructions that cause the processor to output a characterization of a cardiac event based on the cardiac measurement and the biosensor measurement.

16. A method of performing wearable cardiac monitoring, the method comprising: positioning a plurality of wireless ECG electrodes on a patient; calibrating the plurality of wireless ECG electrodes; receiving, from the plurality of wireless ECG electrodes, a cardiac measurement; receiving, from an ICD, an ICD measurement; and determining, based on the ICD measurement and the cardiac measurement, a presence or absence of an arrhythmia.

17. The method of claim 16, wherein calibrating the plurality of wireless ECG electrodes comprises optimizing a detection of P-waves by configuring the position of the plurality of wireless ECG electrodes on the patient.

18. The method of claim 16 or claim 17, wherein at least one of the plurality of wireless ECG electrodes is placed on a limb of the patient.

19. The method of claim 16, further comprising locating the arrhythmia.

20. The method of any one of claims 16-19, further comprising delivering an ICD shock based on the presence or absence of an arrhythmia.

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