Vector sweep for wearable cardioverter defibrillators
The wearable cardiac defibrillator addresses the inefficiency of existing devices by using a rotational sequence of therapeutic shocks delivered by spaced-apart components to convert abnormal cardiac rhythms, improving patient safety.
Patent Information
- Application Number
- PCT/US2025/021492
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-27
- Filing Date
- 2025-03-26
- Publication Date
- 2025-10-02
AI Technical Summary
Existing cardiac treatment devices for ambulatory patients are inadequate in providing effective and timely interventions for life-threatening arrhythmias such as ventricular fibrillation, as they lack a systematic approach to deliver therapeutic shocks that can convert abnormal cardiac rhythms back to normal rhythms efficiently.
A wearable cardiac defibrillator with a plurality of combined ECG and therapy components positioned at spaced-apart anatomical locations on the patient's torso, delivering successive therapeutic shocks in a predetermined rotational sequence using a cardiac controller to monitor ECG signals and control shock delivery.
The wearable defibrillator effectively converts abnormal cardiac rhythms to normal rhythms by delivering vector sweeping therapeutic shocks, enhancing patient safety and reducing the risk of cardiac arrest.
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Figure US2025021492_02102025_PF_FP_ABST
Abstract
Description
VECTOR SWEEP FOR WEARABLE CARDIOVERTER DEFIBRILLATORSCROSS-REFERENCE TO RELATED APPLICATION
[0001] This nonprovisional application claims priority to U.S. Provisional Patent Application Serial No. 63 / 570,254, filed on March 27, 2024, titled “VECTOR SWEEP FOR WEARABLE CARDIOVERTER DEFIBRILLATORS,” the entirety of which is hereby incorporated by reference.BACKGROUND
[0002] The present disclosure relates to a wearable cardiac treatment system configured to treat cardiac arrhythmias occurring in ambulatory and / or in-hospital patients.
[0003] Heart failure, if left untreated, can lead to certain life-threatening arrhythmias. Both atrial and ventricular arrhythmias are common in patients with heart failure. One of the deadliest cardiac arrhythmias is ventricular fibrillation, which occurs when normal, regular electrical impulses are replaced by irregular and rapid impulses, causing the heart muscle to stop normal contractions. Because the victim has no perceptible warning of the impending fibrillation, death often occurs before the necessary medical assistance can arrive. Other cardiac arrhythmias can include excessively slow heart rates known as bradycardia or excessively fast heart rates known as tachycardia. Cardiac arrest can occur when a patient in which various arrhythmias of the heart, such as ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA), and / or asystole (heart stops all electrical activity), result in the heart providing insufficient levels of blood flow- to the brain and other vital organs for the support of life. It is generally useful to monitor heart failure patients to assess heart failure symptoms early and provide interventional therapies as soon as possible.
[0004] Patients may be prescribed to wear cardiac treatment devices for extended periods of time. Cardiac treatment devices may provide defibrillation shocks to the patient if an abnormal cardiac rhythm is detected. Defibrillation shocks are programmed to effectively convert a patient's abnormal cardiac rhythm back to a normal cardiac rhythm.SUMMARY
[0005] In one or more examples, a w earable cardiac defibrillator is configured to provide an ambulatory patient with vector sweeping therapeutic shocks. The wearable cardiac defibrillator includes a plurality of combined electrocardiogram (ECG) and therapy components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient such that theplurality of combined ECG and therapy components are positioned to provide a plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing a torso of the patient. Each combined ECG and therapy component includes one or more electrode surfaces configured to sense surface electrical activity of the patient and deliver one or more of the plurality of successive therapeutic shocks, a combined ECG and therapy component housing mechanically coupled to the one or more electrode surfaces, an ECG sensing circuit disposed within the combined ECG and therapy component housing and configured to receive and process the sensed surface electrical activity of the patient, one or more capacitors disposed within the combined ECG and therapy component housing and configured to store electric energy, and a therapy delivery circuit disposed within the combined ECG and therapy component housing and configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component to the patient using the stored electric energy' of the one or more capacitors. The wearable cardiac defibrillator includes a cardiac controller configured to be operably connected to the plurality of combined ECG and therapy components. The cardiac controller is configured to monitor ECG signals generated from the sensed surface electrical activity of the patient, detect that the patient is experiencing a treatable cardiac arrhythmia, and control delivery' of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the plurality of combined ECG and therapy components.
[0006] Implementations of the wearable cardiac defibrillator can include one or more of the following features. The wearable cardiac defibrillator further includes a garment configured to be worn about the patient’s torso. The garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations. The garment is configured to support the cardiac controller. The garment includes a belt configured to be worn around the patient’s torso. The garment further includes shoulder straps connected to the belt. The shoulder straps are configured to be worn over the patient’s shoulders. The plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart. anatomical locations. The wearable cardiac defibrillator further includes one or more adhesive patches configured to be removably attached to a skin surface of the patient. The cardiac controller is configured to be supported by at least one of the one or more adhesive patches. The plurality of combined ECG and therapy components are configured to be supported by at least one of the one or more adhesive patches.
[0007] Each combined ECG and therapy component further includes one or more gel deployment devices configured to store one or more doses of conductive gel configured to increase conductivity between a skin surface of the patient and the respective combined ECG and therapy component before the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the torso of the patient, and a gel deployment circuit configured to release the one or more doses of conductive gel before the delivery of the plurality of successive therapeutic shocks. The wearable cardiac defibrillator includes a driven ground electrode. One of the plurality of combined ECG and therapy components includes the driven ground electrode. The driven ground electrode is separate from the plurality of combined ECG and therapy components. The driven ground electrode is configured to be electrically isolated from the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient. The driven ground electrode is configured to be electrically isolated through an electrical switch. The driven ground electrode is configured to be electrically isolated through a shunt circuit. The driven ground electrode includes a high resistance configured to electrically isolate the driven ground electrode.
[0008] The wearable cardiac defibrillator includes one or more response buttons configured to be pressed by the patient to delay the delivery of the plurality of successive therapeutic shocks. The cardiac controller includes the one or more response buttons. The wearable cardiac defibrillator includes a user response unit. The user response unit includes the one or more response buttons. The user response unit is configured to be operably coupled to the cardiac controller. The wearable cardiac defibrillator includes a signal processing node configured to be operably coupled to the plurality of combined ECG and therapy components, the cardiac controller, and the user response unit.
[0009] The wearable cardiac defibrillator further includes a signal processing node configured to be operably coupled to the plurality of combined ECG and therapy components and the cardiac controller. The signal processing node includes a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks. The signal processing node includes a driven ground electrode. The signal processing node includes high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each combined ECG and therapy component. The ECG sensing circuit of each combined ECG and therapy component includes a first ECG sensing circuit, and signal processing node includes an ECG sensing electrode surface configured to sense the surface electrical activity of the patient and a second ECGsensing circuit configured to receive and process the sensed surface electrical activity of the patient.
[0010] At least one combined ECG and therapy component of the plurality of combined ECG and therapy components further includes a speaker configured to issue audio alarms to the patient. At least one combined ECG and therapy component of the plurality of combined ECG and therapy components further includes a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient's heart. The cardiovibration sensor is configured to be removably disconnectable from the combined ECG and therapy component housing.
[0011] The cardiac controller includes high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each combined ECG and therapy component. The therapy delivery circuit of each respective combined ECG and therapy component includes a first portion of bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks. The cardiac controller includes a second portion of the bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks. The second portion of the bridge circuitry includes high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each combined ECG and therapy component. The first portion of the bridge circuitry includes a gate driver.
[0012] The ECG sensing circuit of at least one of the plurality of combined ECG and therapy components includes a first ECG sensing circuit. The at least one of the plurality of combined ECG and therapy components further includes a second ECG sensing circuit disposed within the combined ECG and therapy component housing and configured to receive and process the sensed surface electrical activity of the patient. The first ECG sensing circuit corresponds to a first ECG channel and the second ECG sensing circuit corresponds to a second ECG channel. The one or more electrode surfaces include a first ECG sensing electrode surface configured to sense the surface electrical activity7of the patient and a second ECG sensing electrode surface configured to sense the surface electrical activity7of the patient. The first ECG sensing circuit corresponds to the first ECG sensing electrode surface and the second ECG sensing circuit corresponds to the second ECG sensing electrode surface. The wearable cardiac defibrillator further includes one or more ECG sensing electrodes configured to sense the surface electrical activity7. The one or more ECG sensing electrodes are separate from the plurality7of combined ECG and therapy components. The predetermined, spaced-apart, anatomical locations include front torso locations on the patient. The one or more separate ECG sensing electrodes are configured to be disposed against a back torso location of the patient.
[0013] The wearable cardiac defibrillator includes one or more therapy electrodes. Each therapy electrode configured to deliver one or more of the plurality of successive therapeutic shocks. The one or more therapy electrodes are separate from the plurality of combined ECG and therapy components. The predetermined, spaced-apart, anatomical locations include first predetermined, spaced-apart anatomical locations. The one or more separate therapy electrodes are configured to be disposed at one or more second predetermined, spaced-apart, anatomical locations such that the plurality of combined ECG and therapy components along with the one or more therapy electrodes are positioned to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the torso of the patient. The first predetermined, spaced-apart, anatomical locations include front torso locations on the patient. The one or more second predetermined, spaced-apart, anatomical locations include one or more back torso locations on the patient. A therapy electrode of the one or more therapy electrodes includes a driven ground electrode. A therapy electrode of the one or more therapy electrodes includes a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks. At least one therapy electrode of the one or more therapy electrodes includes a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart. The one or more electrode surfaces of each combined ECG and therapy component includes one or more first electrode surfaces and the one or more capacitors disposed within the combined ECG and therapy component housing include one or more first capacitors. Each therapy electrode of the one or more therapy electrodes includes one or more second electrode surfaces configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component, a therapy electrode housing mechanically coupled to the one or more second electrode surfaces, and one or more second capacitors disposed within the therapy electrode housing and configured to store electric energy. The therapy delivery circuit of each respective combined ECG and therapy component includes a first therapy delivery circuit. Each therapy electrode of the one or more therapy electrodes includes a second therapy delivery circuit disposed within the therapy electrode housing and configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective therapy electrode using the stored electric energy’ from the one or more second capacitors to the patient. The second therapy delivery circuit of each respective therapy electrode includes a third portion of bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks. The cardiac controller includes a second portion of the bridge circuitryconfigured to administer the deliver}' of the plurality of successive therapeutic shocks. A therapy electrode of the one or more therapy electrodes includes high-voltage capacitor charging circuitry configured to charge the one or more first capacitors of each combined ECG and therapy component and the one or more second capacitors of each therapy electrode. The one or more therapy electrodes include a first therapy electrode comprising the high-voltage capacitor charging circuity and a second therapy electrode comprising at least one of a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks or a driven ground electrode.
[0014] Each combined ECG and therapy component further includes a shunt circuit configured to isolate the respective combined ECG and therapy component during the delivery of the plurality of successive therapeutic shocks when the respective combined ECG and therapy component is not delivering the one or more of the plurality of successive therapeutic shocks. The shunt circuit includes a switchable diode. Each combined ECG and therapy component further includes a high-voltage electronically controlled switching device configured to isolate the respective combined ECG and therapy component during the delivery of the plurality of successive therapeutic shocks when the respective combined ECG and therapy component is not delivering the one or more of the plurality of successive therapeutic shocks. The high-voltage electronically controlled switching device includes an insulated-gate bipolar transistor (IGBT).
[0015] The predetermined, spaced-apart, anatomical locations include at least one front torso location on the patient and at least one back torso location on the patient. The predetermined, spaced-apart, anatomical locations include at least two front torso locations on the patient and at least two back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include the at least one front torso location on the patient and at least three back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include the at least one front torso location on the patient and at least two back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include at least two front torso locations on the patient and the at least one back torso location on the patient. The predetermined, spaced- apart, anatomical locations include at least three front torso locations on the patient and the at least one back torso location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one left side location on the patient and at least one right side location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one left side location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one right side location on the patient.
[0016] The plurality of successive therapeutic shocks includes at least one therapeutic shock along a plane bisecting the patient's heart. The plurality of successive therapeutic shocks are all along the plane bisecting the patient’s heart. The plurality of successive therapeutic shocks further includes another at least one therapeutic shock non-coplanar to the plane bisecting the patient’s heart. The plane bisecting the patient’s heart intersects a transverse plane across the torso of the patient.
[0017] The predetermined rotational sequence of therapy vectors transversing the torso of the patient includes a plurality of direct vectors. The plurality of direct vectors includes a plurality of two-electrode direct vectors. Each two-electrode direct vector is formed using a two-electrode set selected from the plurality of combined ECG and therapy components and / or one or more therapy electrodes separate from the combined ECG and therapy components. The cardiac controller is configured to deliver a therapeutic shock along each two-electrode direct vector by setting a first member from the respective two-electrode set to a first polarity and setting the other member from the respective two-electrode set to a second polarity from the first member. The plurality of direct vectors includes a plurality of four-electrode direct vectors. Each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from the combined ECG and therapy components and / or one or more therapy electrodes separate from the combined ECG and therapy components. Members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient. The cardiac controller is configured to deliver a therapeutic shock along each four-electrode direct vector by setting a first electrode pair from the respective four-electrode set to a first polarity and setting the other electrode pair from the respective four-electrode set to a second polarity from the first electrode pair.
[0018] The predetermined rotational sequence of therapy vectors transversing the torso of the patient includes a plurality of intermediate therapy vectors. Each intermediate therapy vector is formed using an odd group of at least three electrodes selected from the plurality of combined ECG and therapy components and / or one or more therapy electrodes separate from the plurality of combined ECG and therapy components. The odd group of at least three electrodes includes a first set of at least two electrodes, selected from the combined ECG and therapy components and / or the one or more separate therapy electrodes, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient. The cardiac controller is configured to deliver a therapeutic shock along each intermediate vector by setting members from a first set of at least two electrodes selected from the respective odd group of at least three electrodes to a first polarity and setting the remainingmember or members from the respective odd group of at least three electrode set to a second polarity’ from the first set.
[0019] At least some of the plurality of combined ECG and therapy components are further configured for pacing the patient’s heart by delivering a plurality of pacing pulses. The therapy delivery' circuit of each respective combined ECG and therapy component configured for pacing the patient’s heart is further configured to deliver one or more of the plurality of pacing pulses to the patient using the stored electric energy of the one or more capacitors and via at least one of the one or more electrode surfaces of the respective combined ECG and therapy component configured for pacing the patient’s heart. The at least some of the plurality’ of combined ECG and therapy components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient. The predetermined rotational sequence of therapy vectors traversing the torso of the patient includes a first predetermined rotational sequence of therapy vectors. The at least some of the plurality7of combined ECG and therapycomponents are further configured for pacing the patient’s heart by delivering the plurality7of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
[0020] In one or more examples, a wearable cardiac defibrillator configured to provide an ambulatory patient with vector sweeping therapeutic shocks. The wearable cardiac defibrillator includes a plurality of electrode components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient. At least some of the plurality' of electrode components are configured to receive and process sensed surface electrical activity7of the patient, and at least some of the plurality- of electrode components are configured to provide a plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors transversing a torso of the patient. The wearable cardiac defibrillator includes cardiac controller configured to be operably connected to the plurality' of electrode components. The cardiac controller is configured to monitor electrocardiogram (ECG) signals generated from the sensed surface electrical activity of the patient, detect that the patient is experiencing a treatable cardiac arrhythmia, and control a delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the electrode components configured to provide the plurality- of successive therapeutic shocks.
[0021] The plurality of electrode components includes a plurality7of combined ECG and therapy components. Each combined ECG and therapy component includes one or moreelectrode surfaces configured to sense surface electrical activity of the patient and deliver one or more of the plurality of successive therapeutic shocks, a combined ECG and therapy component housing mechanically coupled to the one or more electrode surfaces, an ECG sensing circuit disposed within the combined ECG and therapy component housing and configured to receive and process the sensed surface electrical activity' of the patient, one or more capacitors disposed within the combined ECG and therapy component housing and configured to store electric energy, and a therapy delivery circuit disposed within the combined ECG and therapy component housing and configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component to the patient using the stored electric energy of the one or more capacitors. Each combined ECG and therapy component further includes one or more gel deployment devices configured to store one or more doses of conductive gel configured to increase conductivity between a skin surface of the patient and the respective combined ECG and therapy component before the delivery' of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the torso of the patient, and a gel deployment circuit configured to release the one or more doses of conductive gel before the delivery of the plurality of successive therapeutic shocks.
[0022] The wearable cardiac defibrillator includes a garment configured to be worn about the patient's torso. The garment is configured to support the plurality of electrode components at the predetermined, spaced-apart, anatomical locations. The garment is configured to support the cardiac controller. The garment includes a belt configured to be worn around the patient’s torso. The garment further includes shoulder straps connected to the belt. The shoulder straps are configured to be worn over the patient’s shoulders. The plurality of electrode components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations. The wearable cardiac defibrillator includes or more adhesive patches configured to be removably attached to a skin surface of the patient. The cardiac controller is configured to be supported by at least one of the one or more adhesive patches. The plurality of electrode components are configured to be supported by at least one of the one or more adhesive patches.
[0023] The wearable cardiac defibrillator further includes a driven ground electrode. One of the plurality of electrode components includes the driven ground electrode. The wearable cardiac defibrillator further includes one or more response buttons configured to be pressed by the patient to delay the delivery of the plurality of successive therapeutic shocks. The cardiac controller includes the one or more response buttons. The wearable cardiac defibrillator furtherincludes a user response unit, wherein the user response unit includes the one or more response buttons. The wearable cardiac defibrillator further includes a signal processing node configured to be operably coupled to the plurality of electrode components, the cardiac controller, and the user response unit.
[0024] The wearable cardiac defibrillator further includes a signal processing node configured to be operably coupled to the plurality of electrode components and the cardiac controller. The signal processing node includes a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks. The signal processing node includes a driven ground electrode. The signal processing node includes high-voltage capacitor charging circuitry' configured to charge one or more capacitors of each combined ECG and therapy component. The signal processing node includes an ECG sensing electrode surface configured to sense the surface electrical activity of the patient and an ECG sensing circuit configured to receive and process the sensed surface electrical activity of the patient. At least one electrode component of the plurality of electrode components further includes a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart.
[0025] Each electrode component of the at least some of the plurality of electrode components configured to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors includes a therapy delivery circuit including a first portion of bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks. The cardiac controller includes a second portion of the bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks. The second portion of the bridge circuitry includes high-voltage capacitor charging circuitry configured to charge one or more capacitors of each combined ECG and therapy component. The first portion of the bridge circuitry includes a gate driver.
[0026] The at least some of the plurality of electrode components configured to receive and process the sensed surface electrical activity of the patient include a plurality of ECG sensing electrodes configured to sense the surface electrical activity. The at least some of the plurality of electrode components configured to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors include a plurality of therapy electrodes. A therapy electrode of the plurality of therapy electrodes includes a driven ground electrode. A therapy electrode of the plurality' of therapy electrodes includes a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks. At least one therapy electrode of the pluralityof therapy electrodes includes a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient's heart. Each therapy electrode of the plurality of therapy electrodes includes one or more electrode surfaces configured to deliver one or more of the plurality of successive therapeutic shocks, a therapy electrode housing mechanically coupled to the one or more electrode surfaces, and one or more capacitors disposed within the therapy electrode housing and configured to store electric energy. A therapy electrode of the one or more therapy electrodes includes high-voltage capacitor charging circuitry configured to charge the one or more first capacitors of each therapy electrode. The one or more therapy electrodes include a first therapy electrode comprising the high-voltage capacitor charging circuity and a second therapy electrode comprising at least one of a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks or a driven ground electrode.
[0027] Each electrode component includes a shunt circuit configured to isolate the respective electrode component during the delivery of the plurality of successive therapeutic shocks when the respective electrode component is not delivering the one or more of the plurality of successive therapeutic shocks. Each electrode component further includes a high-voltage electronically controlled switching device configured to isolate the respective electrode component during the delivery of the plurality of successive therapeutic shocks when the respective electrode component is not delivering the one or more of the plurality of successive therapeutic shocks.
[0028] The predetermined, spaced-apart, anatomical locations include at least one front torso location on the patient and at least one back torso location on the patient. The predetermined, spaced-apart. anatomical locations include at least two front torso locations on the patient and at least two back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include the at least one front torso location on the patient and at least three back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include the at least one front torso location on the patient and at least two back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include at least two front torso locations on the patient and the at least one back torso location on the patient. The predetermined, spaced- apart, anatomical locations include at least three front torso locations on the patient and the at least one back torso location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one left side location on the patient and at least one right side location on the patient. The predetermined, spaced-apart, anatomical locations further includeat least one left side location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one right side location on the patient. The predetermined rotational sequence of therapy vectors trans versing the torso of the patient includes a plurality of direct vectors.
[0029] The plurality of direct vectors includes a plurality of two-electrode direct vectors. Each two-electrode direct vector is formed using a two-electrode set selected from the plurality of electrode components. The plurality of direct vectors includes a plurality of four-electrode direct vectors. Each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from the plurality7of electrode components. Members of each electrode pair are configured to be disposed at adjacent predetennined, spaced-apart, anatomical locations of the ambulatory patient. The predetermined rotational sequence of therapy vectors transversing the torso of the patient includes a plurality of intermediate therapy vectors. Each intermediate therapy vector is formed using an odd group of at least three electrode components selected from the plurality of electrode components. The odd group of at least three electrodes includes a first set of at least two electrode components, selected from the plurality of electrode components, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
[0030] At least some of the plurality7of electrode components are configured for pacing the patient's heart by delivering a plurality of pacing pulses. The at least some of the plurality of electrode components configured for pacing the patient’s heart are further configured to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors. The at least some of the plurality7of electrode components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient. The predetermined rotational sequence of therapy vectors traversing the torso of the patient includes a first predetermined rotational sequence of therapy7vectors. The at least some of the plurality of electrode components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
[0031] In one or more examples, a method for providing an ambulatory patient with vector sweeping therapeutic shocks is implemented. The method includes monitoring ECG signals generated from sensed surface electrical activity of the patient, detecting that the patient is experiencing a treatable cardiac arrhythmia, and controlling delivery of a plurality ofsuccessive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing a torso of the patient.
[0032] Implementations of the method for providing an ambulatory patient with vector sweeping therapeutic shocks can include one or more of the following features. The method further includes delivering one or more alarms to the patient before the delivery of the plurality of successive therapeutic shocks. The method further includes delaying the delivery of the plurality of successive therapeutic shocks based on the patient pressing one or more response buttons. The one or more response buttons are on a user response unit.
[0033] Monitoring the ECG signals generated from the sensed surface electrical activity of the patent includes monitoring the ECG signals generated from surface electrical activity of the patient sensed by a plurality of combined ECG and therapy components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient. Controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors includes controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the plurality of combined ECG and therapy components.
[0034] The method further includes sensing the surface electrical activity of the patient and delivering one or more of the plurality of successive therapeutic shocks via one or more electrode surfaces of each combined ECG and therapy component. The one or more electrode surfaces are mechanically coupled to a combined ECG and therapy component housing. The method further includes receiving and processing the sensed surface electrical activity of the patient via an ECG sensing circuit disposed within the combined ECG and therapy component housing. The method further includes storing electric energy by one or more capacitors disposed within the combined ECG and therapy component housing. The method further includes delivering the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component to the patient using the stored electric energy of the one or more capacitors via a therapy delivery circuit disposed within the combined ECG and therapy component housing. The method further includes storing one or more doses of conductive gel configured to increase conductivity between a skin surface of the patient and the respective combined ECG and therapy component before the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors via one or more gel deployment devices disposed in or mechanically coupled to the combined ECG and therapy component housing. The method further includes releasing the one or more doses of conductive gel before the delivery of the plurality of successive therapeuticshocks by a gel deployment circuit disposed in the combined ECG and therapy component housing.
[0035] The plurality of combined ECG and therapy components are configured to be supported by a garment at the predetermined, spaced-apart, anatomical locations. The plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations. The plurality of combined ECG and therapy components are configured to be supported by one or more adhesive patches. One of the plurality of combined ECG and therapy components includes a driven ground electrode.
[0036] A signal processing node is configured to be operably coupled to the plurality of combined ECG and therapy components. The method further includes delivering one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks via a tactile alarm mechanism. The signal processing node includes the tactile alarm mechanism. The signal processing node includes a driven ground electrode. The method further includes charging one or more capacitors of each combined ECG and therapy component via high-voltage capacitor charging circuitry. The signal processing node includes the high-voltage capacitor charging circuitry. The method further includes generating cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart using one or more cardiovibration sensors. The signal processing node includes the one or more cardiovibration sensors. The plurality of combined ECG and therapy components includes the one or more cardiovibration sensors.
[0037] The predetermined, spaced-apart, anatomical locations include at least one front torso location on the patient and at least one back torso location on the patient. The predetermined, spaced-apart. anatomical locations include at least two front torso locations on the patient and at least two back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include the at least one front torso location on the patient and at least three back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include the at least one front torso location on the patient and at least two back torso locations on the patient. The predetermined, spaced-apart, anatomical locations include at least two front torso locations on the patient and the at least one back torso location on the patient. The predetermined, spaced- apart, anatomical locations include at least three front torso locations on the patient and the at least one back torso location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one left side location on the patient and at least one right side location on the patient. The predetermined, spaced-apart, anatomical locations further includeat least one left side location on the patient. The predetermined, spaced-apart, anatomical locations further include at least one right side location on the patient.
[0038] Controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors includes controlling the delivery of the plurality7of successive therapeutic shocks in a predetermined rotational sequence of therapyvectors including a plurality of direct vectors. The plurality7of direct vectors includes a plurality of two-electrode direct vectors. Each two-electrode direct vector is formed using a two- electrode set selected from a plurality of electrode components. The plurality7of direct vectors includes a plurality7of four-electrode direct vectors. Each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from a plurality of electrode components. Members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
[0039] The predetermined rotational sequence of therapy vectors transversing the torso of the patient includes a plurality of intermediate therapy vectors. Each intermediate therapy vector is formed using an odd group of at least three electrode components selected from a plurality of electrode components. The odd group of at least three electrodes includes a first set of at least two electrode components, selected from the plurality of electrode components, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
[0040] The method further includes pacing the patient’s heart by delivering a plurality of pacing pulses. Pacing the patient’s heart includes pacing the patient’s heart by delivering the plurality7of pacing pulses via a plurality7of combined ECG and therapy components. Controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors includes controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient via the plurality of combined ECG and therapy7components. At least some of the plurality- of combined ECG and therapy components are configured for pacing the patient’s heart and for providing the plurality of successive therapeutic shocks. Pacing the patient’s heart includes pacing the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient. The predetermined rotational sequence of therapy vectors traversing the torso of the patient includes a first predetermined rotational sequence of therapy vectors. Pacing the patient’s heart includes pacing the patient’s heart by delivering the plurality7of pacingpulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
[0041] In one or more examples, a non-transitory computer-readable medium storing sequences of instructions executable by at least one processor, the sequences of instructions instructing the at least one processor to provide an ambulatory patient with vector sweeping therapeutic shocks. The sequences of instructions include instructions to monitor ECG signals generated from sensed surface electrical activity of the patient, detect that the patient is experiencing a treatable cardiac arrhythmia, and control delivery of a plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the torso of the patient.
[0042] Implementations of the non-transitory computer-readable medium can include one or more of the following features. The sequences of instructions further include instructions to deliver one or more alarms to the patient before the delivery of the plurality of successive therapeutic shocks. The sequences of instructions further include instructions to delay the delivery of the plurality of successive therapeutic shocks based on the patient pressing one or more response buttons. The instructions to monitor the ECG signals generated from the sensed surface electrical activity of the patient include instructions to monitor the ECG signals generated from surface electrical activity of the patient sensed by a plurality of combined ECG and therapy components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient. The instructions to control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors include instructions to control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the plurality of combined ECG and therapy components. The sequences of instructions further include instructions to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart. The predetermined, spaced-apart, anatomical locations include at least one front torso location on the patient and at least one back torso location on the patient.
[0043] The sequences of instructions to control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors includes instructions to control the delivery of the plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors including a plurality of direct vectors. The plurality of direct vectors includes a plurality of two-electrode direct vectors. Each two- electrode direct vector is formed using a two-electrode set selected from a plurality of electrode components. The plurality of direct vectors includes a plurality of four-electrode direct vectors.Each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from a plurality of electrode components. Members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
[0044] The predetermined rotational sequence of therapy vectors transversing the torso of the patient includes a plurality of intermediate therapy vectors. Each intermediate therapy vector is formed using an odd group of at least three electrode components selected from a plurality of electrode components. The odd group of at least three electrodes includes a first set of at least two electrode components, selected from the plurality of electrode components, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
[0045] The sequences of instructions further include instructions to pace the patient’s heart by delivering a plurality of pacing pulses. The instructions to pace the patient’s heart include instructions to pace the patient’s heart by delivering the plurality of pacing pulses via a plurality of combined ECG and therapy components. The instructions to pace the patient’s heart include instructions to pace the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient. The predetermined rotational sequence of therapy vectors traversing the torso of the patient includes a first predetermined rotational sequence of therapy vectors. The instructions to pace the patient’s heart include instructions to pace the patient’s heart by delivering the plurality’ of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.BRIEF DESCRIPTION OF THE DRAWINGS
[0046] Various aspects of at least one example are discussed below with reference to the accompanying figures, which are not intended to be drawn to scale. The figures are included to provide an illustration and a further understanding of the various aspects and examples, and are incorporated in and constitute a part of this specification, but are not intended to limit the scope of the disclosure. The drawings, together with the remainder of the specification, sen e to explain principles and operations of the described and claimed aspects and examples. In the figures, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not eve ' component may be labeled in every figure.
[0047] FIG. 1A depicts an example wearable cardiac defibrillator.
[0048] FIG. IB depicts an example electronic architecture for a wearable cardiac defibrillator.
[0049] FIG. 2 depicts an example therapy component placement for a wearable cardiac defibrillator.
[0050] FIG. 3 depicts an example of vector sweeping therapeutic shocks that can be delivered by a wearable cardiac defibrillator.
[0051] FIG. 4 depicts another example of vector sweeping therapeutic shocks that can be delivered by a wearable cardiac defibrillator.
[0052] FIG. 5 depicts another example therapy component placement for a wearable cardiac defibrillator.
[0053] FIG. 6 depicts another example therapy component placement for a wearable cardiac defibrillator.
[0054] FIG. 7A depicts another example therapy component placement for a wearable cardiac defibrillator.
[0055] FIG. 7B depicts another example therapy component placement for a wearable cardiac defibnllator.
[0056] FIG. 7C depicts another example therapy component placement for a wearable cardiac defibrillator.
[0057] FIG. 7D depicts another example therapy component placement for a wearable cardiac defibrillator.
[0058] FIG. 7E depicts another example therapy component placement for a wearable cardiac defibrillator.
[0059] FIG. 7F depicts another example therapy component placement for a wearable cardiac defibrillator.
[0060] FIG. 7G depicts another example therapy component placement for a wearable cardiac defibrillator.
[0061] FIG. 7H depicts another example therapy component placement for a wearable cardiac defibrillator.
[0062] FIG. 8 depicts another example electronic architecture for a wearable cardiac defibrillator.
[0063] FIG. 9 depicts another example electronic architecture for a wearable cardiac defibrillator.
[0064] FIG. 10 depicts another example electronic architecture for a wearable cardiac defibrillator.
[0065] FIG. 11 depicts another example electronic architecture for a wearable cardiac defibrillator.
[0066] FIG. 12 depicts another example electronic architecture for a wearable cardiac defibrillator.
[0067] FIG. 13 depicts another example electronic architecture for a wearable cardiac defibrillator.
[0068] FIG. 14A depicts an example combined ECG and therapy component.
[0069] FIG. 14B depicts another view of the example combined ECG and therapy component of FIG. 14A.
[0070] FIG. 14C depicts another example combined ECG and therapy component.
[0071] FIG. 14D depicts another example combined ECG and therapy component
[0072] FIG. 14E depicts an example of an electrode belt with example electronic architecture for a wearable cardiac defibrillator.
[0073] FIG. 14F depicts another example of an electrode belt with example electronic architecture for a wearable cardiac defibrillator.
[0074] FIG. 14G depicts another example of an electrode belt with example electronic architecture for a wearable cardiac defibrillator.
[0075] FIG. 14H depicts another example of an electrode belt with example electronic architecture for a wearable cardiac defibrillator.
[0076] FIG. 15 depicts an example circuit diagram for therapy components.
[0077] FIG. 16 depicts another example wearable cardiac defibrillator.
[0078] FIG. 17 depicts another example wearable cardiac defibrillator.
[0079] FIG. 18 depicts another example wearable cardiac defibrillator.DETAILED DESCRIPTION
[0080] Wearable cardiac devices implementing the devices, systems, methods, and techniques disclosed herein can be used in various settings to monitor for cardiac arrhythmias and provide treatments, such as defibrillation, cardioversion, or pacing shocks in the event of life-threatening arrhythmias. Upon detecting that the patient is experiencing a treatable arrhythmia, a wearable cardiac device may alert the patient that the wearable cardiac device has determined the patient is experiencing a treatable arrhythmia. The patient may be able to respond to the wearable cardiac device, such as by pressing one or more response buttons, to indicate that the patient is still conscious. If instead the patient does not respond within apredetermined time period, the wearable cardiac device may proceed with delivering one or more treatment shocks to the patient.
[0081] In the case of defibrillation (or cardioversion) shocks, a wearable cardiac device may deliver defibrillation shocks along various vectors through and / or around the patient’s heart using various energies. This disclosure relates to wearable cardiac defibrillators configured to provide an ambulatory patient with vector sweeping therapeutic shocks. For example, these wearable cardiac defibrillators may provide vector sweeping therapeutic shocks as a number of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the patient’s torso. As such, a wearable cardiac defibrillator may include a number of electrode components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient. These electrode components (e.g.. either as separate electrode components or combined electrode components) can sense the surface electrical activity of the patient, which is used to generate ECG signals, and deliver the successive therapeutic shocks to the patient. In addition, a wearable cardiac defibrillator may include a cardiac controller configured to be operably connected to the electrode components. The cardiac controller may thus monitor the patient’s ECG signals to detect whether the patient is experiencing a treatable cardiac arrhythmia condition. After detecting that the patient is experiencing the cardiac arrhythmia condition, the cardiac controller may control the delivery of the successive therapeutic shocks in the predetermined sequence of therapy vectors via the electrode components to restore the patient back to a normal sinus rhythm. In various cases, such a wearable cardiac device may alternatively or additionally provide pacing shocks along similar vectors to treat cardiac arrhythmia conditions, such as bradycardia or asystole.
[0082] In examples, the wearable cardiac defibrillator may include one or more combined ECG and therapy components that are configured to be disposed at predetermined, spaced- apart, anatomical locations of the patient. Each combined ECG and therapy component may include circuitry and other electronic components configured to sense the patient’s surface electrical activity and deliver therapeutic shocks to the patient. For instance, each combined ECG and therapy component may include one or more electrode surfaces, as well as a combined ECG and therapy component housing mechanically coupled to the one or more electrode surfaces. The one or more electrode surfaces may sense the surface electrical activity and physically deliver the therapeutic shocks (e.g., through either the same or different electrode surfaces). In addition, an ECG sensing circuit, one or more capacitors, and a therapy delivery circuit are disposed within the combined ECG and therapy component housing. The ECG sensing circuit is configured to receive and process the sensed electrical activity. The oneor more capacitors are configured to store electric energy, and the therapy delivery circuit is configured to deliver the therapeutic shocks (via the one or more electrode surfaces) using the stored electric energy.
[0083] In implementations, the wearable cardiac defibrillators described herein may additionally or alternatively be configured to deliver multiple sequential defibrillation. As an illustration, the wearable cardiac defibrillators may be configured to deliver a first multiphasic therapeutic pulse along a first vector and a second multiphasic therapeutic pulse along a second vector, via the therapy components of the wearable cardiac defibrillator (e.g., combined ECG and therapy components and / or separate therapy electrodes). The multiphasic therapeutic pulse may be a biphasic therapeutic pulse, a triphasic therapeutic pulse, a quadriphasic therapeutic pulse, etc. For example, in a biphasic therapeutic pulse, a first portion of the pulse may be delivered with a positive polarity (e.g., a positive current from the perspective of a first therapy component to a second therapy component) and a second portion of the pulse may be delivered with a negative polarity (e.g., a negative current from the perspective of the first therapycomponent to the second therapy component). The two portions of the biphasic therapeutic pulse may be separated by a gap of predetermined length (e.g.. a gap of around 0.01 ms to around 1 ms). The first portion and the second portion of the pulse may have the same or different shapes. These shapes may include a square or rectangular waveform, a sawtooth waveform, a truncated exponential waveform, and / or so on. The wearable cardiac defibrillator may also implement a delay between a leading edge of the first multiphasic therapeutic pulse and a leading edge of the second multiphasic therapeutic pulse. In implementations, the delay may be less than the length of the first multiphasic therapeutic pulse such that there is complete or partial overlap between the first and second multiphasic therapeutic pulses. In implementations, the delay may be equal to or greater than the length of the first multiphasic therapeutic pulse such that the wearable cardiac defibrillator delivers the first multiphasic therapeutic pulse followed by' the second multiphasic therapeutic pulse. In implementations, the wearable cardiac defibrillators described herein may additionally or alternatively be configured to deliver monophasic defibrillation pulses.
[0084] In one example use case, a cardiologist may prescribe that a patient at risk for developing a life-threatening arrhythmia use a wearable cardiac defibrillator until the patient can receive an implantable defibrillator. The wearable cardiac defibrillator includes a garment that the patient w ears around their torso, an electrode belt that is assembled into the garment, and a cardiac controller configured to be connected to the electrode belt. The electrode belt includes a number of combined ECG and therapy components that are configured to bedisposed against certain anatomical locations of the patient when the patient is wearing the wearable cardiac defibrillator. In implementations, the electrode belt may also include other separate therapy electrodes and / or other separate ECG sensing electrodes configured to be disposed against other anatomical locations of the patient. As an example, the therapy components of the electrode belt (e.g., the combined ECG and therapy components and / or the separate therapy electrodes) may be configured such that at least one therapy component is disposed against each of the patient’s front torso, back torso, right side, and left side when the patient is wearing the wearable cardiac defibrillator. As another example, the therapy components of the electrode belt may be configured such that multiple therapy components are disposed against the patient's front torso and against the patient’s back torso when the patient is wearing the wearable cardiac defibrillator. For instance, a wearable cardiac defibrillator may include two combined ECG and therapy components configured to be worn against the patient’s front torso, two separate therapy electrodes configured to be worn against the patient’s back torso, and two separate ECG sensing electrodes also configured to be worn against the patient's back torso.
[0085] The cardiac controller is configured to sense when the patient is experiencing a treatable arrhythmia condition, such as using ECG signals generated from surface electrical activity7sensed by the combined ECG and therapeutic components and / or separate ECG sensing electrodes. In response to determining that the patient is experiencing a treatable arrhythmia condition, the cardiac controller provides therapy in the form of vector sweeping therapeutic shocks across vectors formed between the therapy components. For example, each of the therapy components may include one or more capacitors configured to be charged when the cardiac controller detects a treatable arrhythmia condition. The cardiac controller may then control circuitry of the therapy components to administer the release or the stored energy in therapeutic shocks to the patient along a predetermined rotational sequence of the therapy vectors traversing the patient’s torso.
[0086] The cardiac controller is also configured to, prior to delivering the vector sweeping therapeutic shocks, deliver one or more alarms to the patient to alert the patient of the impending therapy. The cardiac controller may deliver the one or more alarms via user interfaces located on the cardiac controller itself, located on a signal processing node also included on the electrode belt, located on a separate patient interface pod, and / or the like. Alarms may include auditory alarms (e.g., a siren, a voice instruction, etc.), visual alarms (e.g., flashing lights, a warning screen, etc.), tactile alarms (e.g., vibrations delivered by a tactile alarm mechanism), and so on. After observing the one or more alarms, the patient may indicateto the cardiac controller that the patient is still conscious by pressing one or more response buttons, for example, located on the cardiac controller, the signal processing node, a combined ECG and therapy electrode, a separate patient interface pod, and / or the like. The cardiac controller may then delay or abort the therapy delivery.
[0087] In another example use case, a cardiologist may prescribe a wearable cardiac defibrillator for a patient at risk of developing life-threatening arrhythmias but who is not physically well enough to receive an implantable defibrillator. The wearable cardiac defibrillator may include adhesive therapy components configured to be removably adhesively attached to the patient’s torso. In examples, the adhesive therapy components may include combined ECG and therapeutic components that both sense the patient’s surface electrical activity and deliver therapeutic shocks to the patient. Additionally, in example, the wearable cardiac defibrillator may also include separate adhesive ECG sensing electrodes configured to sense the patient’s surface electrical activity. The adhesive therapy components (and, in examples, adhesive ECG sensing electrodes) are configured to be electrically coupled to a cardiac controller. The patient may wear the cardiac controller (e.g., in a carrying case, mounted on a garment that the patient wears around their torso, etc.), or the cardiac controller may also be adhesively attached to the patient. The cardiac controller determines when the patient is experiencing a treatable arrhythmia condition and, in response, controls delivery of vector sweeping therapeutic shocks via the therapy components of the wearable cardiac defibrillator.
[0088] The wearable cardiac defibrillators described herein may provide advantages over prior art systems. In implementations, providing therapeutic shocks to a patient through vectors sweeps may be at least as efficient at converting the patient’s cardiac arrhythmia back into a normal sinus rhythm compared to non-vector sweeping therapeutic shocks. The ability’ to convert a patient with at least the same efficiency, while distributing the energy more around the patient’s body along the sequence of vectors used in the vector sweeping therapy delivery, offers the opportunity' to reduce potential tissue damage. In various use cases, vector sweeping therapeutic shocks may be more efficient at converting the patient back to a normal sinus rhythm compared to non-vector sweeping therapeutic shocks. Such efficiency may be derived because electric fields depolarize cardiomyocytes in an orientation-selective manner, with maximally-effective depolarization occurring when the cell’s long axis is parallel to the electric field vector. Vector sweeping therapeutic shocks may thus help maximize the effect of the electric field vectors applied to the myocardial tissue, the cells of which are known to be oriented non-uniformly. As such, the wearable cardiac defibrillator may deliver less energy tothe patient, allowing for smaller high-voltage components (e g., smaller capacitors, miniaturized gate drivers, a smaller battery to charge the capacitors, etc.). In turn, the smaller high-voltage components may form a wearable cardiac defibrillator that is lighter and thus more comfortable for the patient to wear, thus improving the chances that the patient will comply with a prescription to use the wearable cardiac defibrillator. Less energy' delivered to the patient may also mean that it is less likely the patient will suffer from bums or other adverse skin effects from receiving the therapeutic shocks.
[0089] Additionally, regardless of the efficiency of vector sweeping therapeutic shocks, distributing at least some of the high-voltage parts to the therapy components as described herein may further provide additional comfort and wearability' to the device. For example, in a wearable cardiac defibrillator that includes a cardiac controller and therapy components (e.g., combined ECG and therapy components and / or separate therapy electrodes), the capacitors used to provide therapeutic shocks and at least some of the high-voltage circuitry can be integrated into the therapy components instead of the cardiac controller. In turn, this may help shrink the size of the cardiac controller and better distribute the weight of the wearable cardiac defibrillator around the patient’s torso, making the wearable cardiac defibrillator easier for the patient to wear and more user-friendly.
[0090] FIG. 1A illustrates an example of a wearable cardiac defibrillator 200, according to implementations disclosed herein. As shown in FIG. 1 A, the wearable cardiac defibrillator 200 is external and wearable by a patient 202 around the patient’s torso. Such a wearable cardiac defibrillator 200 can be, for example, capable and designed for moving with the patient 202 as the patient 202 goes about their daily routine. For instance, the wearable cardiac defibrillator 200 may be configured to be bodily-attached to the patient 202, such as by the patient 202 donning the wearable cardiac defibrillator 200 and securing the wearable cardiac defibrillator 200 in place through a closure. In one example scenario, the wearable cardiac defibrillator 200 can be worn nearly continuously or substantially continuously for an extended period of time, such as a week, two weeks, a month, two months, three months, six months, etc. During the period of time in which the wearable cardiac defibrillator 200 is worn by the patient 202, the wearable cardiac defibrillator can be configured to continuously or substantially continuously monitor the vital signs of the patient 202 and can be configured to, upon determination that treatment is required, deliver one or more therapeutic electrical pulses to the patient 202. For example, such therapeutic shocks can be pacing, defibrillation, cardioversion, and / or transcutaneous electrical nerve stimulation (TENS) pulses. In embodiments, the wearablecardiac defibrillator 200 may be a wearable cardioverter defibrillator and configured to synchronize therapeutic shocks with the patient's cardiac cycles.
[0091] As noted above, regardless of the extended period of wear, the use of the wearable cardiac defibrillator 200, as well as other embodiments of wearable cardiac defibrillators discussed below, can include continuous or nearly continuous wear by the patient as described above. For example, the continuous use can include continuous wear or attachment of the wearable cardiac defibrillator to the patient during both periods of monitoring and periods when the wearable cardiac defibrillator may not be monitoring the patient but is otherwise still worn by or otherwise attached to the patient. The wearable cardiac defibrillator can be configured to continuously monitor the patient for cardiac-related information (e.g., ECG information, including arrhythmia information, cardiovibrations, and / or the like) and / or non-cardiac information (e.g., blood oxygen, the patient’s temperature, glucose levels, tissue fluid levels, lung vibrations, and / or the like). The wearable cardiac defibrillator can carry out its monitoring in periodic or aperiodic time intervals or times. For example, the monitoring during interv als or times can be triggered by a user action or another event. As an illustration, the wearable cardiac defibrillator may continuously monitor the patient while the wearable cardiac defibrillator is turned on and detects at least a minimum level of electrode attachment to the patient.
[0092] As also discussed above, the wearable cardiac defibrillator is continuously used, except for sporadic periods during which the use temporarily ceases. Examples of temporary cessation include while the patient bathes, while the patient is refit with anew and / or a different garment, while adhesive patches are being replaced, while the battery is charged / changed, while the garment is laundered, and / or the like. Such substantially or nearly continuous use as described herein may nonetheless be considered continuous use. For example, the wearable cardiac defibrillator can be configured to be worn by a patient for as many as 24 hours a day. As another example, the patient can remove the wearable cardiac defibrillator for a short portion of the day (e.g., for half an hour to bathe).
[0093] As shown in FIG. 1 A, the wearable cardiac defibrillator 200 can include one or more ECG sensing electrodes 204a-d (collectively referred to herein as sensing electrodes 204) configured to contact the patient’s skin and sense electrical cardiac activity of the patient 202, one or more therapy electrodes 206a and 206b (collectively referred to herein as therapy electrodes 206) configured to deliver therapeutic shocks to the heart of the patient 202, and a cardiac controller 214 operably connected to the sensing electrodes 204 and the therapy electrodes 206. As shown, the wearable cardiac defibrillator 200 can also include a garment208 configured to be worn about the torso of the patient 202, where the garment 208 is configured to support the sensing electrodes 204 and the therapy electrodes 206. For instance, as shown, the garment 208 may be configured in a vest-like configuration for wear over the patient’s upper torso. In implementations, the wearable cardiac defibrillator 200 can include additional elements, such as a signal processing node 210, a patient interface pod 212, additional sensors or detectors, or any combination of these. Examples of additional sensors or detectors include one or more motion detectors configured to generate motion data indicative of physical activity being performed by the patient 202, wear state sensors configured to detect a wear state of the wearable cardiac defibrillator 200 (e.g., whether the patient 202 is wearing the wearable cardiac defibrillator 200 or not), vibrational or bioacoustics sensors configured to generate cardiovibrational or bioacoustics signals indicative of cardiovibrational or bioacoustics markers for the heart of the patient 202, respiration sensors configured to generate respiration signals indicative of respiration activity of the patient 202, thoracic fluid sensors configured to generate thoracic fluid signals indicative of a thoracic fluid level of the patient 202, and / or the like.
[0094] In implementations, some or all of the sensing electrodes 204, the therapy electrodes 206, the signal processing node 210, the patient interface pod 212, additional sensors or detectors, and the like may be configured to be assembled onto the garment 208. For example, at least some of the components of the wearable cardiac defibrillator 200 can be configured to be removably mounted or affixed on the garment 208, such as by mating hooks, hook-and-loop fabric strips, receptacles (e.g., pockets), snaps (e.g., plastic or metal snaps), and the like. As an illustration, the sensing electrodes 204 may be removably attached to the garment 208 by hook- and-loop fabric strips on the sensing electrodes 204 and the garment 208. As another illustration, the therapy electrodes 206 may be removably attached to the garment 208 by being inserted into receptacles on the garment 208. In implementations, at least some of the components of the wearable cardiac defibrillator 200 can be permanently integrated into the garment 208, such as by being sewn into the garment 208 or by being adhesively secured to the garment 208 with a permanent adhesive. In examples, at least some of the components may be connected to each other through external cables, through internal or sewn-in connections (e.g., wires woven into the fabric of the garment 208), through conductive fabric of the garment 208, and / or the like. Component configurations other than those shown in FIG. 1A are also possible. For example, the sensing electrodes 204 may be configured to be attached at other positions about the body of the patient 202 and / or may include additional or fewer electrodes 204. As another example, the therapy electrodes 206 may be configured to be attached at otherpositions about the body of the patient 202 and / or may include additional or fewer electrodes 206.
[0095] As noted above, the cardiac controller 214 can be operatively coupled to the sensing electrodes 204 and the therapy electrodes 206. In implementations, the cardiac controller 214 may be directly coupled to at least some of the sensing electrodes 204 and / or therapy electrodes 206. In implementations, and as shown in FIG. 1 A, the cardiac controller 214 may be indirectly coupled to at least some of the sensing electrodes 204 and / or therapy electrodes 206, such as through another component of the wearable cardiac defibrillator 200 like the signal processing node 210. In implementations, the cardiac controller 214 may also be configured to be assembled into the garment 208. For example, the entire cardiac controller 214 as shown in FIG. 1A may be configured to be inserted into or attached to a receptacle of the garment 208, such as a pocket. As another example, the functions of the cardiac controller 214 may be dispersed among multiple cardiac controller units (e.g., a cardiac arrhythmia monitoring unit, a therapy delivery7unit, a communications unit, an alarm unit, etc.). To illustrate, the multiple cardiac controller units may include individual units for each of some or all of the components shown in the electronic architecture of FIG. IB. These multiple cardiac controller units may then be inserted into and / or attached to receptacles of the garment 208.
[0096] As noted above, the sensing electrodes 204 can be configured to sense electrical cardiac activity of the patient 202. Example sensing electrodes 204 may include a metal electrode with an oxide coating, such as tantalum pentoxide electrodes. For instance, by design, the sensing electrodes 204 can include skin-contacting electrode surfaces that may be deemed polarizable or non-polarizable depending on a variety7of factors, including the metals and / or coatings used in constructing the electrode surface. All such electrodes can be used with the principles, techniques, devices, and systems described herein. For instance, the electrode surfaces can be based on stainless steel, noble metals such as platinum, or Ag-AgCl.
[0097] In implementations, the sensing electrodes 204 can be used with an electrolytic gel dispersed between the electrode surface and the patient’s skin. In implementations, the sensing electrodes 204 can be dry electrodes that do not need an electrolytic material. As an example, such a dry electrode can be based on tantalum metal, such as by having a tantalum pentoxide coating as is described above. Such dry electrodes can be more comfortable for long-term monitoring applications.
[0098] In implementations, the sensing electrodes 204 can include additional components such as accelerometers, acoustic signal detecting devices (e.g., vibrational sensors), and other measuring devices for recording other types of parameters for the patient 202. For example,the sensing electrodes 204 can also be configured to detect other patient physiological parameters and acoustic signals, such as tissue fluid levels, heart vibrations, lung vibrations, respiration vibrations, patient movement, etc. In some examples, the therapy electrodes 206 can additionally or alternatively be configured to include sensors configured to detect electrical cardiac activity' of the patient 202 as well as, or in the alternative to, other physiological parameters or signals from the patient 202.
[0099] The signal processing node 210 can. in various examples, include a signal processor configured to amplify, filter, and / or digitize signals (e.g., ECG signals generated from the sensed electrical cardiac activity' of the patient 202) prior to transmitting the signals to the cardiac controller 214. As an example, the signal processing node 210 may be configured to reduce and / or remove noise in the signals received from the sensing electrodes 204. As another example, the signal processing node 210 may be configured to digitize the signals received from the sensing electrodes 204, such as through an analog-to-digital converter. In implementations, the sensing electrodes 204 may instead include circuitry' to amplify, filter, and / or digitize signals prior to transmitting the signals to the cardiac controller 214. For example, the sensing electrodes 204 may digitize ECG signals, and the signal processing node 210 may reduce and / or remove noise using ground signals from a ground electrode.
[0100] In implementations, the wearable cardiac defibrillator 200 may include a driven ground electrode. The driven ground electrode may be implemented as one of the sensing electrodes 204. one of the therapy electrodes 206. and / or as a separate provided elsewhere on the wearable cardiac defibrillator 200. The driven ground electrode may be used to reduce the effects of noise and / or detect if an electrode (e.g., one of the sensing electrodes 204) has fallen off from the patient’s skin surface or otherwise become disconnected from the rest of the wearable cardiac defibrillator 200. For example, in implementations, the signal processing node 210 or another component of the wearable cardiac defibrillator (e.g., the cardiac controller 214) may inject a signal having a higher frequency than the frequencies normally observed in an ECG waveform via the driven ground electrode. The sensing electrodes 204 can detect the high-frequency driven ground signals. Detection of the high-frequency driven ground signals indicates that the sensing electrodes 204 are still in contact with the patient’s skin. Failing to detect the high-frequency driven ground signals may' be an indication that the respective sensing electrode 204 has fallen off of the patient’s skin. The cardiac controller 214 can assign lower confidence levels to signals derived from sensing electrodes 204 that the cardiac controller 214 has determined have fallen off.
[0101] Although the signal processing node 210 is shown as attached to the garment 208 at patient's front in FIG. 1A, in examples the signal processing node 210 may be attached to the garment 208 at the small of the patient's back. In such implementations, because the signal processing node 210 at located against the small of the patient’s back where the patient may be sensitive to feeling movement, the signal processing node 210 can be configured to include one or more vibration motors to provide tactile notifications to the patient 202. For instance, the signal processing node 210 can receive one or more signals from the cardiac controller 214 and provide a tactile alert to the patient 202 based on the one or more signals from the cardiac controller 214, as described in further detail below.
[0102] In implementations, the cardiac controller 214 is configured to monitor the ECG signals generated from the electrical cardiac activity sensed by the sensing electrodes 204 and determine when the patient 202 is experiencing a treatable cardiac arrhythmia. The therapy electrodes 206 are configured to deliver one or more electrical therapeutic shocks to the patient 202, such as one or more therapeutic cardioversion / defibrillation shocks to the body of the patient 202, when the cardiac controller 214 determines that treatment is warranted. Example therapy electrodes 206 can include conductive metal electrodes such as stainless-steel electrodes. In implementations, the therapy electrodes 206 include one or more conductive gel deployment devices configured to deliver conductive gel between the metal electrode and the patient's skin prior to delivery of a therapeutic shock.
[0103] Accordingly, in implementations, the cardiac controller 214 is configured to determine whether the patient 202 is experiencing a treatable cardiac arrhythmia based on the patient's ECG signals. The cardiac controller 214 is further configured to instruct delivery of one or more electrical therapeutic shocks to the patient 202 via the therapy electrodes 206 in response to determining that the patient 202 is experiencing a treatable cardiac arrhythmia. The functionality of the cardiac controller 214 is described in further detail below with respect to FIG. IB.
[0104] In implementations, the signal processing node 210 may be configured to control at least part of the delivery of the therapeutic shocks. As an example, the signal processing node 210 may receive a signal from the cardiac controller 214 initiating a therapy delivery sequence. The signal processing node 210 may send a signal to the therapy electrodes 206 to activate the deployment of conductive electrolytic gel at the therapy electrodes 206 (e.g., from an integrated or removable gel pack on each therapy electrode 206). The signal processing node 210 may then receive one or more therapeutic charges from the cardiac controller 214 and convey theone or more therapeutic charges to the therapy electrodes 206 for delivery of the one or more therapeutic shocks to the patient 202.
[0105] In implementations, the cardiac controller 214 is also configured to warn the patient 202 prior to the delivery of a therapeutic shock, such as via one or more output devices integrated into or connected to the cardiac controller 214, the signal processing node 210, and / or the patient interface pod 212. In implementations, the patient interface pod 212 can be secured to a hook-and-loop fastener, or a plastic or metal snap connector, a clip, a buckle, etc. disposed on the shoulder strap of the garment 208 and / or on the patient interface pod 212. The warning, for example, may be auditory (e.g., a siren alarm, a voice instruction indicating that the patient 202 is going to be shocked, etc.), visual (e.g., flashing lights on the cardiac controller 214, etc.), haptic (e.g.. a tactile, buzzing alarm generated by the signal processing node 210, etc.), and / or the like. For example, the cardiac controller 214 may deliver alarms warning the patient 202 of an impending therapeutic shock via speakers on the cardiac controller 214 or the signal processing node 210 (e.g., where the alarm includes a siren that increases in volume over time, verbal warnings that the patient 202 is going to receive a therapeutic shock, verbal instructions informing the patient 202 to avoid a therapeutic shock by pressing the one or more response buttons, as outlined below, and / or the like). As another example, the cardiac controller 214 may deliver alarms via a screen or other lights of the cardiac controller 214 or patient interface pod 212 (e.g., by displaying a warning on the screen of the cardiac controller 214, by lighting up LEDs on the cardiac controller 214. and / or the like). As another example, the cardiac controller 214 may deliver alarms by causing the signal processing node 210 to vibrate against the patient’s back, as described above. In implementations, alarms may include combinations of some or all of these examples. In implementations, alarms may escalate over time, such as by including louder sounds, higher frequencies, more frequent warnings, stronger vibrations, and / or the like.
[0106] If the patient 202 is still conscious, the patient 202 may be able to delay or stop the delivery' of the therapeutic shock. In implementations, the patient 202 may press one or more response buttons to indicate to the cardiac controller 214 that the patient 202 is still conscious. Such response buttons may be provided, for example, on the cardiac controller 214 and / or on the patient interface pod 212. In response to the patient 202 pushing the one or more response buttons, the cardiac controller 214 may delay or stop the delivery of the therapeutic shock. For example, the cardiac controller 214 may include response buttons provided on opposite sides of the cardiac controller 214 that the patient 202 must push simultaneously to delay or cancel the therapeutic shock. In such examples, the wearable cardiac defibrillator 200 may not includea patient interface pod 212. As another example, the patient interface pod 212 may include one or more response buttons that the patient 202 must push to delay or cancel the therapeutic shock. In implementations, the patient 202 may need to press a response button on the patient interface pod 212 and the cardiac controller 214 simultaneously to delay or cancel the therapeutic shock. In implementations, the patient interface pod 212 may be implemented as a wireless response button unit, for example, implemented as a watch or wristband that the patient 202 wears along with the garment 208. As another illustration, the wearable cardiac defibrillator 200 may not include a patient interface pod. Instead, a patient user device, such as a smartphone, may sen e as the response button unit. For example, the cardiac controller 214 may communicate with the smartphone (e.g., via Bluetooth®, via cellular networks, etc.) and cause the smartphone to display a button, a link, or so on that the patient 202 must press to delay or cancel the therapeutic shock. In implementations, the wearable cardiac defibrillator 200 may include combinations of the above ty pes of response buttons.
[0107] FIG. IB illustrates a sample component-level view' of a cardiac controller 250, which is an example of the cardiac controller 214 of FIG. 1A. As shown in FIG. IB, the cardiac controller 250 may include a housing 252 configured to house a number of electronic parts, including a sensor interface 254, a data storage 256, a network interface 258, a user interface 260, at least one battery 262 (e.g., positioned within a battery' chamber configured for such a purpose), a cardiac event detector 264, an alarm manager 266, a therapy delivery circuit 268, and at least one processor 270. In implementations, the processor 270 includes one or more processors (or one or more processor cores) that are each configured to perform a series of instructions that result in the manipulation of data and / or the control of the operation of the other components of the cardiac controller 250. In implementations, when executing a specific process (e.g.. monitoring sensed surface electrical signals of the patient 202), the processor 270 can be configured to make specific logic-based determinations based on input data received. The processor 270 may be further configured to provide one or more outputs that can be used to control or otherwise inform subsequent processing to be carried out by the processor 270 and / or other processors or circuitry to which the processor 270 is communicably coupled. Thus, the processor 270 reacts to a specific input stimulus in a specific way and generates a corresponding output based on that input stimulus. In example cases, the processor 270 can proceed through a sequence of logical transitions in which various internal register states and / or other bit cell states internal or external to the processor 270 may be set to logic high or logic low'.
[0108] As referred to herein, the processor 270 can be configured to execute a function where software is stored in a data store (e.g.. the data storage 256) coupled to the processor 270, the software being configured to cause the processor 270 to proceed through a sequence of various logic decisions that result in the function being executed. The various components that are described herein as being executable by the processor 270 can be implemented in various forms of specialized hardware, software, or a combination thereof. For example, the processor 270 can be a digital signal processor (DSP) such as a 24-bit DSP processor. As another example, the processor 270 can be a multi-core processor, e g., having two or more processing cores. As another example, the processor 270 can be an Advanced RISC Machine (ARM) processor, such as a 32-bit ARM processor. The processor 270 can execute an embedded operating system and further execute services provided by the operating system, where these services can be used for file system manipulation, display and audio generation, basic networking, firewalling, data encryption, communications, and / or the like.
[0109] The data storage 256 can include one or more of non-transitory computer-readable media, such as flash memory, solid state memory, magnetic memory’, optical memory, cache memory, combinations thereof, and others. The data storage 256 can be configured to store executable instructions and data used for operation of the cardiac controller 250. In implementations, as described above, the data storage 256 can include sequences of executable instructions that, when executed, are configured to cause the processor 270 to perform one or more functions. Additionally, the data storage 256 can be configured to store information such as digitized ECG signals of the patient 202.
[0110] In examples, the network interface 258 can facilitate the communication of information between the cardiac controller 250 and one or more devices or entities over a communications network. For example, the network interface 258 can be configured to communicate with a remote server or other similar computing device. Using the network interface 258, the wearable cardiac defibrillator 200 may transmit, for example, ECG signals, other phy siological signals, indications of abnormal cardiac events, etc., to the remote server. In implementations, the network interface 258 can include communications circuitry for transmitting data in accordance with a Bluetooth® wireless standard for exchanging such data over short distances to an intermediary’ device or devices (e.g., abase station, “hotspot” device, smartphone, tablet, portable computing device, and / or other device in proximity with the wearable cardiac defibrillator 200). The intermediary device(s) may in turn communicate the data to the remote server over a broadband cellular network communications link. The communications link may implement broadband cellular technology (e.g., 2.5G, 2.75G, 3G,4G. 5G cellular standards) and / or Long-Term Evolution (LTE) technology' or GSM / EDGE and UMTS / HSPA technologies for high-speed wireless communication. In some implementations, the intermediary device(s) may communicate with the remote server over a Wi-Fi communications link based on the IEEE 802.11 standard. In implementations, the network interface 258 may be configured to instead communicate directly with the remote server without the use of intermediary device(s). In such implementations, the network interface 258 may use any of the communications links and / or protocols provided above to communicate directly with the remote server.[OHl] The sensor interface 254 can include physiological signal circuitry that is coupled to one or more sensors 272 configured to be externally applied to the patient 202. As shown, the sensors 272 may be coupled to the cardiac controller 250 via a wired or wireless connection. The sensors 272 may include, for example, the ECG electrodes 204 configured to sense surface electrical signals indicative of ECG activity from the skin surface of the patient 202, as w ell as one or more non-ECG sensors such as a cardiovibration sensor 274 and a tissue fluid monitor 276. Other examples of external sensors 272 may include a respiration sensor, a bioacoustics sensor, a blood pressure sensor, a temperature sensor, a pressure sensor, a humidity sensor, a P-wave sensor (e g., a sensor configured to monitor and isolate P-waves within an ECG waveform), an oxygen saturation sensor (e.g., implemented through photoplethysmography, such as through light sources and light sensors configured to transmit light into the patient’s body and receive transmitted and / or reflected light containing information about the patient’s oxygen saturation), and so on.
[0112] As an illustration, the sensor interface 254 may receive ECG signals generated by the ECG electrodes 204 along one or more ECG channels, where each ECG channel includes a pair of ECG electrodes 204. In implementations, and as discussed above, the sensor interface 254 may receive ECG signals that are preprocessed. For example, the ECG electrodes 204 and / or the signal processing node 210 may digitize, filter, remove noise, and / or the like from the ECG signals before sending the ECG signals to the sensor interface 254. In implementations, the sensor interface 254 may perform at least some of the processing of the ECG signals. The sensor interface 254, for instance, may digitize, filter, remove noise, and / or the like. In examples, the sensor interface 254 may use driven ground signals from a driven ground electrode to determine whether the ECG electrodes 204 are still sufficiently in contact with the patient’s skin.
[0113] As another illustration, the one or more cardiovibration sensors 274 can be configured to detect cardiac or pulmonary vibration information. The one or morecardiovibration sensors 274 can transmit information descriptive of the cardiovibrations (and other types of sensed vibrations) to the sensor interface 254 for subsequent analysis. For example, the one or more cardiovibration sensors 274 can detect the patient’s heart valve vibration information (e.g., from opening and closing during cardiac cycles). As a further example, the one or more cardiovibration sensors 274 can be configured to detect cardiovibrational signal values including one or more of SI, S2, S3, and S4 cardiovibrational biomarkers. From these cardiovibrational signal values or heart vibration values, certain heart vibration metrics may be calculated (e.g., at the wearable cardiac defibrillator 200 and / or at a remote server). These heart vibration metrics may include one or more of electromechanical activation time (EMAT), average EMAT, percentage of EMAT (% EMAT), systolic dysfunction index (SDI), or left ventricular systolic time (LVST). In implementations, the cardiovibrational signal values from the one or more cardiovibration sensors 274 can be used to detect whether the patient is experiencing a treatable arrhythmia.
[0114] The one or more cardiovibration sensors 274 can also be configured to detect heart wall motion, for instance, by placement of the sensor in the region of the apical beat. In implementations, the one or more cardiovibration sensors 274 can include a vibrational sensor configured to detect vibrations from the patient’s cardiac and pulmonary system and provide an output signal responsive to the detected vibrations of a targeted organ. For example, the one or more cardiovibration sensors 274 may be configured to detect vibrations generated in the trachea or lungs due to the flow of air during breathing. In implementations, additional physiological information can be determined from pulmonary-vibrational signals such as, for example, lung vibration characteristics based on sounds produced within the lungs (e.g., stridor, crackle, etc.). In implementations, the one or more cardiovibration sensors 274 can include a multi-channel accelerometer, for example, a three-channel accelerometer configured to sense movement in each of three orthogonal axes such that patient movement / body position can be detected and correlated to detected cardiovibration information.
[0115] As another illustration, the tissue fluid monitor 276 may include a radiofrequency (RF) sensor configured to take bio-impedance measurements of the patient’s thorax. In implementations, sensor interface 254 may use the bio-impedance measurements to determine a thoracic fluid level in the patient 202. An example embodiment of the tissue fluid monitor 276 includes at least one RF antenna, such as a transmitting antenna and a receiving antenna, or a single antenna configured to transmit and receive RF waves. The tissue fluid monitor 276 also includes RF circuitry (e.g., implemented by the sensor interface 254) configured to transmit a low-power signal in an ultra-high frequency band (e.g., 0.1 GHz to 5.0 GHz, 0.5GHz to 2.1 GHz) at a predetermined rate (e.g., every 10 ms, every 20 ms, every 30 ms, every 40 ms, every 50 ms, etc.). The tissue fluid monitor 276 receives RF -based biosignals indicative of the thoracic fluid level in the patient 202 in the form of RF waves transmitted through the patient 202, scattered by the patient 202, and / or reflected from the patient 202. For example, the tissue fluid monitor 276 may detect transmitted, scattered, and / or reflected RF waves for a predetermined amount of time (e.g., about 30 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 5 minutes, about 10 minutes, etc.).
[0116] In implementations, the wearable cardiac defibrillator 200 is configured to gate when RF measurements are taken and / or discard certain RF measurements based on the patient’s state when the RF measurements were taken. For example, the sensor interface 254 may determine whether the patient 202 showed movement above a predetermined threshold before tissue fluid monitor 276 started the RF measurements process and / or while the RF measurements were taking place. If RF measurements were taken during or immediately after movement above the predetermined threshold, the sensor interface 254 may discard those RF measurements. In implementations, at least some of the analysis and / or gating of RF measurements may be performed by a remote server. As an example, the cardiac controller 250 may transmit the RF measurements to the remote server via the network interface 258 and receive back from the remote server a determined thoracic fluid level.
[0117] In implementations, the sensor interface 254 may be connected to one or more motion sensors (e.g.. one or more accelerometers, gyroscopes, magnetometers, ballistocardiographs, etc.) as part of the externally applied sensors 272. In implementations, the cardiac controller 250 may include a motion sensor interface 278, either implemented separately or as part of the sensor interface 254. For instance, as shown in FIG. IB, the cardiac controller 250 may include a motion sensor interface 278 operatively coupled to one or more motion detectors 280 configured to generate motion data, for example, indicative of physical activity performed by the patient 202 and / or physiological information internal to the patient 202. Examples of a motion detector may include a 1-axis channel accelerometer, 2-axis channel accelerometer, 3- axis channel accelerometer, multi-axis channel accelerometer, gyroscope, magnetometer, ballistocardiograph, and the like. For instance, the motion data may include accelerometer counts indicative of physical activity performed by the patient 202, accelerometer counts indicative of respiration rate of the patient 202, accelerometer counts indicative of posture information for the patient 202, accelerometer counts indicative of cardiovibrational information for the patient 202, and / or the like.
[0118] The motion sensor interface 278 is configured to receive one or more outputs from the motion sensor(s) 280. The motion sensor interface 278 can be further configured to condition the output signals by, for example, converting analog signals to digital signals (if using an analog motion sensor), filtering the output signals, and / or combining the output signals into a combined directional signal (e.g., combining each x-axis signal into a composite x-axis signal, combining each y-axis signal into a composite y-axis signal, and combining each z-axis signal into a composite z-axis signal). In examples, the motion sensor interface 278 can be configured to filter the signals using a high-pass or band-pass filter to isolate the acceleration of the patient 202 due to movement from the component of the acceleration due to gravity. Additionally, the motion sensor interface 278 can configure the outputs from a given motion sensor 280 for further processing. For example, the motion sensor interface 278 can be configured to arrange the output of an individual motion sensor 280 as a vector expressing acceleration components of the x-axis, the y-axis, and the z-axis of the motion sensor 280. The motion sensor interface 278 can thus be operably coupled to the processor 270 and configured to transfer the output and / or processed motion signals from the motion sensor(s) 280 to the processor 270 for further processing and analysis.
[0119] In implementations, the one or more motion sensors 280 can be integrated into one or more components of the wearable cardiac defibrillator 200, either within the cardiac controller 250 or external to the cardiac controller 250, as shown in FIG. IB. For instance, in some implementations, the one or more motion detectors 280 may be located in or near the ECG electrodes 204. In some implementations, the one or more motion detectors 280 may be located elsewhere on the wearable cardiac defibrillator 200. For example, a motion detector 280 may be integrated into the cardiac controller 250 (e.g., such that the one or more motion detectors 280 would be located within the housing 252 of the cardiac controller 250, as shown in FIG. IB). In some implementations, a motion detector 280 may be integrated into another component of the wearable cardiac defibrillator 200, such as a therapy electrode 206, the signal processing node 210, and / or the like. In some implementations, a motion detector 280 can be integrated into an adhesive ECG sensing and / or therapy electrode patch.
[0120] In implementations, the sensor interface 254 and / or the processor 270 may be configured to provide digitized ECG signals of the patient 202 based on electrical signals sensed by the ECG electrodes 204. In this sense, the sensor interface 254 and / or the processor 270 may be considered an ECG digitizing circuit. The digitized ECG signals of the patient 202 may be stored in the data storage 256. In implementations, the signal processing node 210 may instead perform the digitizing of the ECG signals, as discussed above. In implementations, thesensing electrodes 204 themselves may instead digitize the ECG signals, as further discussed above.
[0121] As previously described, the sensor interface 254 and the motion sensor interface 278 can be coupled to any one or combination of external sensors to receive patient data indicative of patient parameters. Once data from the sensors has been received by the sensor interface 254 and / or the motion sensor interface 278. the data can be directed by the processor 270 to an appropriate component within the cardiac controller 250. For example. ECG signals collected by the ECG electrodes 204 may arrive at the sensor interface 254, and the sensor interface 254 may transmit the ECG signals to the processor 270, which, in turn, relays the patient’s ECG data to the cardiac event detector 264. The sensor data can also be stored in the data storage 256 and / or transmitted to a remote server via the network interface 258.
[0122] In implementations, the cardiac event detector 264 can be configured to monitor the patient’s ECG signal for an occurrence of a cardiac event such as an arrhythmia or other similar cardiac event. The cardiac event detector 264 can be configured to operate in concert with the processor 270 to execute one or more methods that process received ECG signals from, for example, the sensing electrodes 204 and determine the likelihood that the patient 202 is experiencing a cardiac event, such as a treatable arrhythmia. The cardiac event detector 264 can be implemented using hardware or a combination of hardware and software. For instance, in some examples, the cardiac event detector 264 can be implemented as a software component that is stored within the data storage 256 and executed by the processor 270. In this example, the instructions included in the cardiac event detector 264 can cause the processor 270 to perform one or more methods for analyzing a received ECG signal to determine whether an adverse cardiac event is occurring, such as a treatable arrhythmia. In other examples, the cardiac event detector 264 can be an application-specific integrated circuit (ASIC) that is coupled to the processor 270 and configured to monitor ECG signals for adverse cardiac event occurrences. Thus, examples of the cardiac event detector 264 are not limited to a particular hardware or software implementation.
[0123] In implementations, the cardiac event detector 264 may determine that the patient is experiencing an arrhythmia using a combination of heart rate and / or cardiac cycle morphology. For example, the cardiac event detector 264 may determine the patient’s heart rate from ECG signals (e.g., generated by the sensor interface 254). As an illustration, the cardiac event detector 264 may use a QRS detector to identify R peaks and calculate the patient's heart rate based on the time period between adjacent R peaks. As another illustration, the cardiac event detector 264 may perform a fast Fourier transform (FFT) on the ECG signals, with the FFTdecomposing the analog ECG waveform into its frequency components. The cardiac event detector 264 may then analyze the output of the FFT to determine the strongest frequency component indicative of heart rate. Once the cardiac event detector 264 has determined the patient’s heart rate, the cardiac event detector 264 may then identify whether the patient’s heart rate transgresses one or more arrhythmia thresholds. To illustrate, the cardiac event detector 264 may determine if the patient’s heart rate is below a threshold for ventricular tachycardia, at or above the threshold for ventricular tachycardia but below a threshold for ventricular fibrillation, or at or above the threshold for ventricular fibrillation.
[0124] As another example, the cardiac event detector 264 may alternately or additionally determine the patient’s current vectorcardiogram from their ECG signals. For instance, the ECG sensors 204 may be positioned around the patient’s torso when the patient is wearing the wearable cardiac defibrillator 200 to form orthogonal leads (e.g., front-to-back and side-to-side at the level of the patient’s xiphoid process). The cardiac event detector 264 may determine a direction and magnitude of the electrical forces in the patient’s heart and plot them (e.g., on an x-y or an x-y-z graph) to form a vectorcardiogram. The cardiac event detector 264 may then determine whether the patient’s current vectorcardiogram matches a baseline vectorcardiogram. To illustrate, the cardiac event detector 264 may take a baseline vectorcardiogram for the patient 202 during a setup period and / or periodically during the patient’s use of the wearable cardiac defibrillator 200 (e g., weekly at a predetermined time, after the patient 202 is delivered a therapeutic shock, etc.). The cardiac event detector 264 may then compare the patient’s current vectorcardiogram to the patient’s baseline vectorcardiogram to determine if the two morphologies match with a predetermined degree of accuracy. If the patient's current vectorcardiogram does not match their baseline vectorcardiogram, this failure to match may serve as evidence that the patient 202 is experiencing a treatable and / or alertable arrhythmia. If the patient’s current vectorcardiogram does match their baseline vectorcardiogram with the predetermined degree of accuracy, this match may serve as evidence that the patient 202 is not experiencing a treatable and / or alertable arrhythmia.
[0125] In implementations, the cardiac event detector 264 may use a combination of heart rate and / or cardiac cycle morphology to determine whether the patient is experiencing a treatable arrhythmia. For example, the cardiac event detector 264 may determine whether the patient's current vectorcardiogram matches a baseline vectorcardiogram in response to the patient’s heart rate transgressing an arrhythmia threshold. The cardiac event detector 264 may then output an indication that the patient 202 is experiencing an arrhythmia if the patient’s current vectorcardiogram does not match their baseline vectorcardiogram with a predetermineddegree of accuracy. In implementations, the cardiac event detector 264 may use additional inputs and / or measures to determine whether the patient is experiencing an arrhythmia. For instance, the cardiac event detector 264 may use cardiovibrational signals from the cardiovibration sensor 274 to determine the patient’s heart rate (e.g., based on the presence of SI and S2 cardiovibrational biomarkers corresponding to the closing of the patient’s heart valves). As another example the cardiac event detector 264 may use the cardiovibrational signals to detect the whether the patient is exhibiting S3 or S4 cardiovibrational biomarkers, which may indicate heart failure.
[0126] In implementations, the user interface 260 may include one or more physical interface devices, such as input devices, output devices, and combination input / output devices, as well as a software stack configured to drive operation of the devices. These user interface elements may render visual, audio, and / or tactile content. Thus, the user interface 260 may receive inputs and / or provide outputs, thereby enabling a user to interact with the cardiac controller 250. Examples of user interfaces 260 include speakers, display screens, touch screens, tactile motors, and / the like.
[0127] The cardiac controller 250 can also include at least one battery 262 configured to provide power to one or more electronic parts integrated in the cardiac controller 250. The battery 262 can include a rechargeable multi-cell battery' pack. In one example implementation, the battery 262 can include three or more cells (e.g., 2200 mA lithium ion cells) that provide electrical power to the other device components within the cardiac controller 250. For example, the battery 262 can provide its power output in a range of between a 20 mA to 1000 mA (e.g., 40 mA) output and can support 24 hours, 48 hours, 72 hours, or more of runtime between charges. In certain implementations, the battery capacity, runtime, and type (e.g., lithium ion, nickel-cadmium. or nickel-metal hydride) can be changed to best fit the specific application of the cardiac controller 2000.
[0128] Additionally, the wearable cardiac defibrillator 200 is configured to provide therapeutic shocks to the patient 202 upon the cardiac event detector 264 detecting that the patient 202 is experiencing a treatable arrhythmia. The therapy delivery circuit 268 can be coupled to the therapy electrodes 206 that are configured to provide therapy to the patient 202. For example, the therapy delivery circuit 268 can include, or be operably connected to, circuitry components that are configured to generate and provide an electrical therapeutic shock. The circuitry components can include, for example, resistors, capacitors, relays and / or switches, electrical bridges such as an H-bridge (e.g., including a plurality of insulated gate bipolar transistors or IGBTs), voltage and / or current measuring components, and other similar circuitrycomponents. The circuitry' components are arranged and connected such that the circuitry components work in concert with the therapy delivery circuit 268 and under the control of one or more processors (e.g., processor 270) to provide, for example, one or more pacing, defibrillation, or cardioversion therapeutic pulses. In implementations, pacing pulses can be used to treat cardiac arrhythmias such as bradycardia (e.g., less than 30 beats per minute) and tachycardia (e.g., more than 150 beats per minute) using, for example, fixed rate pacing, demand pacing, anti -tachycardia pacing, and the like. For instance, defibrillation or cardioversion pulses can be used to treat ventricular tachycardia and / or ventricular fibrillation.
[0129] In implementations, the therapy delivery' circuit 268 includes a first high-voltage circuit connecting a first pair of the therapy electrodes 206 (e.g., the therapy electrode 206a and one of the therapy electrodes 206b) and a second high-voltage circuit connecting a second pair of the therapy electrodes 206 (e.g., the therapy electrode 206a and the other of the therapy electrodes 206b). Using the high-voltage circuits, the therapy delivery circuit 268 can deliver a first therapeutic shock, such as a first biphasic therapeutic pulse, via the first high-voltage circuit and a second therapeutic shock, such as a second biphasic therapeutic pulse, via the second high-voltage circuit. In implementations, the second high-voltage circuit is configured to be electrically7isolated from the first high-voltage circuit. In implementations, the therapy delivery' circuit 268 includes a capacitor configured to be selectively connected to the first high- voltage circuit and / or the second high-voltage circuit. As such, the first high-voltage circuit may be powered by the capacitor when the capacitor is selectively connected to the first high- voltage circuit, and the second high-voltage circuit may be powered by the capacitor when the capacitor is selectively connected to the second high-voltage circuit. In implementations, the therapy delivery circuit 268 includes a first capacitor electrically connected to the first high- voltage circuit and a second capacitor electrically connected to the second high-voltage circuit.
[0130] The capacitors can include a parallel -connected capacitor bank consisting of a plurality of capacitors (e.g., two, three, four, or more capacitors). In some examples, the capacitors can include a single film or electrolytic capacitor as a series connected device including a bank of the same capacitors. These capacitors can be switched into a series connection during discharge for a defibrillation pulse. For example, four capacitors of approximately 140 pF or larger, or four capacitors of approximately 650 pF can be used. The capacitors can have a 1600 VDC or higher rating for a single capacitor, or a surge rating between approximately 350 to 500 VDC for paralleled capacitors and can be charged in approximately 15 to 30 seconds from a battery’ pack.
[0131] For example, each defibrillation pulse can deliver between 60 J to 180 J of energy. In some implementations, the defibrillating pulse can be a biphasic truncated exponential waveform, whereby the signal can switch between a positive and a negative portion (e.g., charge directions). This type of waveform can be effective at defibrillating patients at lower energy levels when compared to other types of defibrillation pulses (e.g., such as monophasic pulses). For example, an amplitude and a width of the two phases of the energy waveform can be automatically adjusted to deliver a precise energy amount (e.g., 150 J) regardless of the patient’s body impedance. The therapy delivery circuit 268 can be configured to perform the switching and pulse delivery operations, e.g., under control of the processor 270. As the energy is delivered to the patient 202, the amount of energy being delivered can be tracked. For example, the amount of energy can be kept to a predetermined constant value even as the pulse waveform is dynamically controlled based on factors, such as the patient’s body impedance, while the pulse is being delivered. In certain examples, the therapy delivery' circuit 268 can be configured to deliver a set of cardioversion pulses to correct, for example, an improperly beating heart. When compared to defibrillation as described above, cardioversion often includes a less powerful shock that is delivered at a certain frequency to mimic a heart’s normal rhythm.
[0132] The alarm manager 266 can be implemented using hardware or a combination of hardware and software. For instance, in some examples, the alarm manager 266 can be implemented as a software component that is stored within the data storage 256 and executed by the processor 270. In this example, the instructions included in the alarm manager 266 can cause the processor 270 to configure alarm profiles and notify intended recipients using the alarm profiles. In other examples, the alarm manager 266 can be an application-specific integrated circuit (ASIC) that is coupled to the processor 270 and configured to manage alarm profiles and notify intended recipients using alarms specified within the alarm profiles. Thus, examples of the alarm manager 266 are not limited to a particular hardware or software implementation.
[0133] In implementations, the alarm manager 266 can be configured to manage alarm profiles and notify one or more intended recipients of events, where an alarm profile includes a given event and the intended recipients who may have in interest in the given event. These intended recipients can include external entities, such as users (e.g., patients, physicians and other caregivers, a patient’s loved one, monitoring personnel), as well as computer systems (e.g., monitoring systems or emergency response systems, which may be included in the remote server or may be implemented as one or more separate systems). For example, in response tothe cardiac event detector 264 described above determining that the patient 202 is experiencing a treatable arrhythmia, the therapy delivery circuit 268 is configured to deliver a cardioversion / defibrillation shock to the patient 202 via the therapy electrodes 206. However, when the cardiac event detector 264 determines using data from the sensing electrodes 204 that the patient 202 is experiencing a treatable arrhythmia and before delivering the therapeutic shock, the alarm manager 266 may issue an alarm (e g., via the user interface(s) 260, via the patient interface pod 212. and / or via the signal processing node 210) that the patient 202 is about to experience a defibrillating shock. The alarm may include auditory, tactile, and / or other ty pes of alerts. In some implementations, the alerts may increase in intensity' over time, such as increasing in pitch, increasing in volume, increasing in frequency, switching from a tactile alert to an auditory alert, and so on.
[0134] Additionally, in some implementations, the alerts may inform the patient 202 that the patient 202 can abort the delivery of the defibrillating shock by interacting with the user interface 260 or another component of the wearable cardiac defibrillator 200. For instance, the patient 202 may be able to press a user response button or user response buttons of the user interface 260, after which the alarm manager 266 will cease issuing an alert and the therapy delivery circuit 268 will no longer prepare to deliver or will delay' delivering the therapeutic shock. In implementations, the patient 202 may additionally or alternatively be able to interact with one or more user interface buttons disposed elsewhere on the wearable cardiac defibrillator 200. such as on patient interface pod 212 (e.g., press a user response button or user response buttons on the patient interface pod 212), to abort or delay the therapeutic shock.
[0135] In implementations, a wearable cardiac defibrillator, such as the wearable cardiac defibrillator 200 discussed above or the wearable cardiac defibrillators discussed below with respect to FIGS. 16-18, can be configured to provide vector sweeping therapeutic shocks to an ambulatory patient. With vector sweeping therapeutic shocks, the wearable cardiac defibrillator delivers energy' in a sequence with defined timing, where the goal is to “sweep” the current direction through the patient’s body through the heart at vary ing angles. Accordingly, components designed to deliver the therapeutic energy are disposed at predetermined, spacedapart, anatomical locations of the patient such that these therapy components can deliver the vector sweeping therapeutic shocks. For instance, therapy components can include combined ECG and therapy components and / or separate therapy electrodes, as described in further detail below. As an illustration, FIG. 2 shows an example therapy component placement that can be used to provide vector sweeping therapeutic shocks to the heart 300 of a patient. In the example of FIG. 2, a first therapy component 302a is configured to be disposed against a front torsolocation on a patient, a second therapy component 302b is configured to be disposed against a right side location on the patient, a third therapy component 302c is configured to be disposed against a back torso location on the patient, and a fourth therapy component 302d is configured to be disposed against a left side location on the patient (e.g., collectively, therapy components 302). Various vectors may be formed between the therapy components 302. Examples of such vectors are also shown in FIG. 2, including (1) a vector a between the left side therapy component 302d and right side therapy component 302b, (2) a vector b between the front torso therapy component 302a and back torso therapy component 302c, (3) a vector c between the front torso therapy component 302a and the right side therapy component 302b, (4) a vector d between the right side therapy component 302b and the back torso therapy component 302c, (5) a vector e between the back torso therapy component 302c and left side therapy component 302d, and (6) a vector f between the left side therapy component 302d and the front torso therapy component 302a.
[0136] In various embodiments, a wearable cardiac defibrillator can deliver vector sweeping therapeutic shocks as number of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the patient’s torso. For example. FIG. 3 shows an example of vector sweeping therapeutic shocks that can be delivered by a wearable cardiac defibrillator. According to the example of FIG. 3, a first shock 400 can be delivered along a first vector, a second shock 402 can be delivered along a second vector, a third shock 404 can be delivered along a third vector, and a fourth shock 406 can be delivered along a fourth vector. As an illustration, referring back to FIG. 2, the first shock 400 can be delivered along vector a where therapy component 302d is set to a high voltage and therapy component 302b is set to a low voltage. The second shock 402 can be delivered along vector b where therapy component 302a is set to a high voltage and therapy component 302c is set to a low voltage. The third shock 404 can be delivered along vector a where therapy component 302b is set to a high voltage and therapy component 302d is set to a low voltage. Finally, the fourth shock 406 can be delivered along vector b where therapy component 302c is set to a high voltage and therapy component 302a is set to a low voltage.
[0137] FIG. 4 illustrates another example of vector sweeping shocks that can be delivered by a wearable cardiac defibrillator. Vectors through a patient’s heart 500 can be defined using two pairs of therapy components: therapy components 502a and 502c and therapy components 502b and 502d. For example, with reference to FIG. 2, therapy component 502a may correspond to therapy component 302a. therapy component 502b may correspond to therapy component 302b, therapy component 502c may correspond to therapy component 302c, andtherapy component 502d may correspond to therapy component 302d. In the example of FIG. 4, the vectors through the patient’s heart 500 include vector A defined by setting therapy component 502a to a high voltage and therapy component 502c to a low voltage, vector B defined by setting therapy components 502a and 502b to a high voltage and therapy components 502b and 502d to a low voltage, vector C defined by setting therapy component 502b to a high voltage and therapy component 502d to a low voltage, and vector D defined by setting therapy components 502b and 502c to a high voltage and therapy components 502d and 502a to a low voltage. Additional vectors -A, -B, -C, and -D can be defined by reversing the high / low voltages of vectors A, B, C, and D, respectively. As such, when the wearable cardiac defibrillator including therapy components 502a-d delivers vector sweeping therapeutic shocks, the wearable cardiac defibrillator may deliver a series of therapeutic shocks in a predetermined rotational sequence of vector A, vector B, vector C, vector D, vector -A, vector -B, vector -C, and vector -D, as shown in vector sequence diagram 504.
[0138] FIGS. 2-4 illustrate examples of therapy component configurations and therapeutic shock sequences. However, various therapy component configurations and / or various therapeutic shock sequences can be used to deliver vector sweeping therapeutic shocks to a patient. FIG. 5 illustrates another example of a therapy component placement that can be used to deliver vector sweeping therapeutic shocks. In the example of FIG. 5, three therapy components 506a, 506b, and 506c are configured to be disposed on either a front or back torso location of a patient, and one therapy component 506d is configured to be disposed on the other of a front or back torso location of the patient (collectively, therapy components 506). Vectors formed between the therapy components 506 can include (1) vector g formed between therapy components 506b and 506c, (2) vector h formed between therapy components 506a and 506d, (3) vector j formed between therapy components 506a and 506c, (4) vector k formed between therapy components 506a and 506b, (5) vector m formed between therapy components 506b and 506d, and (6) vector n formed between therapy components 506c and 506d.
[0139] FIG. 6 illustrates yet another example of a therapy component placement that can be used to deliver vector sweeping therapeutic shocks. In this example, the wearable cardiac defibrillator includes therapy components 600a and 600b configured to be disposed on first and second front torso locations of a patient and therapy components 600c and 600d configured to be disposed on first and second back torso locations of the patient (collectively, therapy components 600). Vectors between the therapy components 600 may include (1) vector p formed between the first front torso therapy component 600a and the second back torso therapy component 600d, (2) vector q formed between the second front torso therapy component 600band the first back torso therapy component 600c. (3) vector r formed between the first front torso therapy component 600a and the second front torso therapy component 600b, (4) vector s formed between the second front torso therapy component 600b and the second back torso therapy component 600d, (5) vector t formed between the first back torso therapy component 600c and the second back torso therapy component 600d, and (6) vector u formed between the first front torso therapy component 600a and the first back torso therapy component 600c.
[0140] Other locations and / or number of therapy components can be used to deliver vector sweeping therapeutic shocks. In examples, therapy components may be disposed at predetermined, spaced-apart, anatomical locations that include at least one front torso location on the patient and at least one back torso location on the patient. Such examples may include the configurations shown in FIGS. 2. 5, and 6, as well as additional configurations. To illustrate, the predetermined, spaced-apart, anatomical locations may include at least two front torso locations on the patient and at least two back torso locations, such as the configuration of FIG. 6. As another illustration, the predetermined, spaced-apart, anatomical locations may include at least one front torso location on the patient and at least three back torso locations on the patient. As another illustration, the predetermined, spaced-apart. anatomical locations may include at least three front torso locations on the patient and at least one back torso location on the patient. These illustrations may include, for instance, the configuration shown in FIG. 5. As another illustration, the predetermined, spaced-apart, anatomical locations may include at least one front torso location on the patient and at least two back torso locations on the patient. Example locations of this illustration may be demonstrated by the configuration of the therapy electrodes 206 in FIG. 1 A. As another illustration, the predetermined, spaced-apart, anatomical locations may include at least one left side location on the patient. As another illustration, the predetermined, spaced-apart, anatomical locations may include at least one right side location on the patient. As another illustration, the predetermined, spaced-apart, anatomical locations may include at least two front torso location on the patient and at least one back torso location on the patient. As another illustration, the predetermined, spaced-apart, anatomical locations may include at least one left side location on the patient and at least one right side location on the patient, such as the configurations shown in FIGS. 2 and 4.
[0141] In addition, various numbers of therapy components may be used. For example, a wearable cardiac defibrillator may include three therapy components, four therapy components, five therapy components, six therapy components, seven therapy components, eight therapy components, etc. For instance, a wearable cardiac defibrillator may include six therapy components configured to be disposed on three front torso locations and three backtorso locations. As another illustration, a wearable cardiac defibrillator may include eight therapy components configured to be disposed on four front torso locations and four back torso locations. As another illustration, a wearable cardiac defibrillator may include five or more therapy components disposed equidistantly from each other around the patient’s torso. In implementations, the predetermined, spaced-apart, anatomical locations may include various anatomical locations across and around the patient’s torso, for example, to accommodate a large number of therapy components, such as more than ten.
[0142] Additionally, FIGS. 2, 5, and 6 illustrate vectors through and around the patient’s heart along a single plane bisecting the patient’s heart. However, in implementations, the therapy components may be configured to be disposed such that vectors are created between the therapy components along multiple planes bisecting the patient’s heart. As an example, therapy components may be offset from each other according to a Z-axis running from the patient’s head to their feet such that vectors are formed along multiple planes. Accordingly, in implementations, the vector sweeping successive therapeutic shocks include at least one therapeutic shock along a plane bisecting the patient’s heart. In implementations, the vector sweeping successive therapeutic shocks are all along the plane bisecting the patient’s heart. In implementations, the vector sweeping successive therapeutic shocks include at least one therapeutic shock non-coplanar to the plane bisecting the patient’s heart. In implementations, such a plane bisecting the patient's heart are parallel to a transverse plane across the torso of the patient. In implementations, such a plane bisecting the patient’s heart intersects a transverse plane across the torso of the patient.
[0143] In implementations, the predetermined rotational sequence of therapy vectors traversing the patient’s heart may include one or more therapy vectors that are aligned with or against the myocardial fibers of the patient’s heart. The myocardial fibers are spindle-like muscular fibers forming the patient’s heart. Together, the myocardial fibers twist to form the atria and the ventricles of the heart. As such, at least some of the therapy vectors may be oriented to he, for example, parallel to or perpendicular to a portion of the myocardial fibers. For example, the therapy vectors may include one or more vector parallel to a long axis of a portion of myocardial fibers. As another example, the therapy vectors may include one or more vector perpendicular to a long axis of a portion of myocardial fibers.
[0144] Additionally, the predetermined rotational sequence of therapy vectors transversing the torso of the patient may include direct vectors and / or intermediate vectors. In implementations, direct vectors may be formed between therapy components when the number of therapy components set to a first polarity (e.g., a high voltage or a low voltage) is the sameas the number of therapy components set to a second polarity (e.g.. the other of a high or low voltage). For example, a direct vector may be a two-electrode direct vector between a set of two therapy components (e.g., selected from combined ECG and therapy components and / or separate therapy electrodes, as described in further detail below). A wearable cardiac defibrillator may deliver a therapeutic shock along each two-electrode direct vector by setting a first member of the set of two therapy components to a first polarity (e.g., a high voltage or a low voltage) and setting the other member of the set of two therapy components to a second polarity (e.g., the other of the high voltage or low voltage). To illustrate, vectors A and -A are two-electrode direct vectors in FIG. 4, formed between therapy components 502a and 502c. Similarly, vectors C and -C are two-electrode direct vectors in FIG. 4, formed between therapy components 502b and 502d. Such two-electrode direct vectors may be referred to as first order vectors.
[0145] As another example, a direct vector may be a four-electrode direct vector formed from a four-electrode set of two pairs of therapy components (e.g., selected from combined ECG and therapy components and / or separate therapy components, again as described in further detail below). In implementations, within each pair of therapy components, the therapy components are configured to be disposed at adjacent predetermined, spaced- apart, anatomical locations on the ambulatory patient. The wearable cardiac defibrillator is configured to deliver a therapeutic shock along each four-electrode direct vector by setting a first electrode pair from the four-electrode set to a first polarity (e.g., a high voltage or a low voltage) and setting the other electrode pair from the four-electrode set to a second polarity (e.g., the other of the high or low voltage). For instance, vectors B, D, -B, and -D are four-electrode direct vectors in FIG. 4, created by therapy components 502. Within the therapy components 502, a first pair of the therapy components 502 are configured to be disposed at adjacent anatomical locations on the patient and are set to a first polarity. A second pair of the therapy components 502 are also configured to be disposed at adj acent anatomical locations on the patient and are set to a second polarity. For example, to create vector B, therapy components 502a and 502b serve as the first pair and are set to a high voltage, and therapy components 502c and 502d serve as the second pair and are set to a low voltage. Conversely, to create vector D. therapy components 502b and 502c serve as the first pair set to a high voltage, and therapy components 502a and 502d sen e as the second pair set to a low voltage. Such four-electrode direct vectors may be referred to as second order vectors.
[0146] In implementations, intermediate vectors may be formed when the number of therapy components set to a first polarity (e.g., a high voltage or a low voltage) is not the same as thenumber of therapy components set to a second polarity (e.g., the other of a high or low voltage). For example, an intermediate therapy vector may be formed from at least three therapy components (e.g., selected from combined ECG and therapy components and / or separate therapy electrodes, as discussed in further detail below). Other intermediate therapy vectors may be formed from other, odd numbers of therapy components. Within the therapycomponents configured to form an intermediate therapy vector, a first set within the therapy components (e.g., including at least two electrodes) are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient. The remaining set of therapy components may be a solo therapy component or multiple therapy components also configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient separate from the locations of the first set. For instance, in an intermediate vector formed from three therapy components, two therapy components may be disposed at adjacent locations on the patient, and the third therapy component may be disposed across the patient's torso from the other two therapy components. The wearable cardiac defibrillator may deliver a therapeutic shock along an intermediate vector by setting the members of the first set within the therapy components to a first polarity (e.g.. a high voltage or a low voltage) and may set the remaining member or members of therapy components to a second polarity- from the first set (e.g., the other of the high or low voltage).
[0147] As an illustration, referring to FIG. 4, an intermediate AB vector may be formed using therapy components 502a, 502b, and 502c. The wearable cardiac defibrillator may set therapy components 502a and 502b to a high voltage and therapy component 502c to a low voltage. The direction of the intermediate AB vector may be determined by summing the individual vectors between the therapy components 502a and 502c and between the therapy components 502b and 502c. Other intermediate vectors can be formed with the therapy component configuration shown in FIG. 4. For instance, an intermediate BC vector can be formed by setting therapy components 502a and 502b to a high voltage and therapy component 502d to a low voltage. An intermediate CD vector can be formed by setting therapy components 502b and 502c to a high voltage and therapy component 502d to a low voltage. An intermediate D-A vector can be formed by setting therapy- components 502b and 502c to a high voltage and therapy component 502a to a low voltage, and so on. As such, in implementations, a wearable cardiac defibrillator may deliver vector sweeping therapeutic shocks to a patient along vector A, vector AB, vector B, vector BC, vector C, vector CD, vector D, vector D-A, vector -A, vector -A-B, vector -B, vector -B-C. vector -C, vector -C-D, vector -D. and vector -DA.
[0148] In implementations, a wearable cardiac defibrillator may deliver therapeutic shocks along the predetermined rotational sequence of therapy vectors traversing the torso of the patient may be in a single rotational order. As an illustration, referring again to FIG. 4 and as discussed above, the wearable cardiac defibrillator may deliver therapeutic shocks in a sequence of vector A, vector B, vector C, vector D, vector -A, vector -B, vector -C, and vector -D. In examples, the wearable cardiac defibrillator can repeat this sequence to deliver therapeutic shocks in additional rotations. In implementations, the predetermined rotational sequence of therapy vectors traversing the torso of the patient may be in a rotational order that includes multiple angles of rotation. To illustrate, with reference to FIG. 4, the wearable cardiac defibrillator may deliver therapeutic shocks in a sequence of vector A, vector B, vector C, vector -A, vector -B, and vector -C. As such, the wearable cardiac defibrillator does not deliver therapeutic shocks in a single rotational order around the patient’s torso but instead delivers therapeutic shocks in multiple angles of rotation that are non-adjacent. As another illustration, the wearable cardiac defibrillator may deliver additional therapeutic shocks in a sequence of vector C. vector D, vector -A. vector -C, vector -D, and vector A. In this way, the wearable cardiac defibrillator delivers therapeutic shocks around the entirety of the patient’s torso but not in a single rotational order. Instead, the wearable cardiac defibrillator delivers therapeutic shocks by jumping between non-adjacent angles of rotation. In implementations, the wearable cardiac defibrillator may deliver therapeutic shocks in other non-adjacent rotational orders, such as with multiple angles of rotation that are non-adjacent and of different amounts. In implementations, the wearable cardiac defibrillator may repeat vectors. To illustrate the foregoing, the wearable cardiac defibrillator may deliver therapeutic shocks in a sequence of vector A, vector B, vector -C, vector D, vector -A, vector B, vector -C, vector -D, and vector - A. As another illustration, the wearable cardiac defibrillator may deliver therapeutic shocks in a sequence of vector A, vector B, vector B, vector C, vector D, vector D, and vector -A. Other rotational sequences are contemplated and covered by the present disclosure.
[0149] In implementations, the wearable cardiac defibrillator may deliver at least some of the therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient simultaneously. For example, the successive therapeutic shocks of vector sweeping therapy may include therapeutic shocks delivered by multiple therapy component pairs simultaneously. As an illustration, again referring to FIG. 4, the wearable cardiac defibrillator may deliver therapeutic shocks along vectors A and C simultaneously. The wearable cardiac defibrillator may then deliver therapeutic shocks along vectors -A and -C simultaneously. The deliver}' of therapeutic shocks along vectors A and C and along vectors -A and -C may form the successive therapeutic shocks in a predetermined rotational sequence, or the delivery of therapeutic shocks along vectors A and C and along vectors -A and -C may be part of a larger predetermined rotational sequence. As another illustration, the wearable cardiac defibrillator may include a larger number of therapy components, such as eight therapy components. In such examples, the wearable cardiac defibrillator may deliver additional shocks simultaneously, such as four simultaneous shocks between four pairs of the eight therapy components, as part of the successive therapeutic shocks in the predetermined rotational sequence.
[0150] In implementations, the wearable cardiac defibrillator may be configured to modify the successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the patient’s torso, for example, based on patient feedback. For instance, the cardiac controller of the wearable cardiac defibrillator may determine that the current delivered by a first set of vectors is less than expected. As such, after delivering the successive therapeutic shocks in the predetermined rotational sequence, the wearable cardiac defibrillator may repeat the therapeutic shocks delivered via the first set of vectors after to ensure that the patient receives a sufficient therapy to convert the arrhythmia cardiac rhythm back into a regular cardiac rhythm. As another example, the cardiac controller may modify the successive therapeutic shocks in real time based on a feedback loop. For instance, the cardiac controller may measure impedance and current while delivering a therapeutic shock along one of the therapy vectors and increase or decrease the delivered current, duration, and / or future vector timing to achieve target values. As another example, after delivering the vector sweeping therapeutic shocks and converting the patient back into a regular cardiac rhythm, the cardiac controller may analyze the amount of current delivered by the therapeutic shocks and adjust the predetermined rotational sequence of therapy vectors to favor more effective vectors for future defibrillations. Alternatively, the wearable cardiac defibrillator may transmit the data from the vector sweeping therapeutic shocks to a remote server that provides this analysis and sends the adjusted rotational sequence of therapy vectors to the cardiac controller to store for future defibrillations.
[0151] In implementations, the wearable cardiac defibrillator may be configured with one or more fallback options for delivering therapeutic shocks. As an illustration, in preparing to deliver vector sweeping therapeutic shocks, the cardiac controller may determine whether there is an issue with one or more of the therapy components. For example, the cardiac controller may use falloff signals from each of the therapy components to determine whether each therapy component has been installed properly and has good contact with the patient’s skin. As anotherexample, the cardiac controller may determine whether there is a communication issue with any of the therapy components (e.g., by transmitting a signal to each of the therapy components and ensuring that the cardiac controller receives a return signal). If the cardiac controller identifies one or more therapy components that seem to be an experiencing, e.g., an installation or communications issue, the cardiac controller may adjust the predetermined rotational sequence of therapy vectors to avoid the therapy component(s) with an issue. For instance, the cardiac controller may skip any vectors that use the therapy component(s) at issue and / or create additional intermediate vectors for the predetermined rotational sequence to make up for the lack of skipped or less effective vectors from the therapy component(s) at issue. In implementations, the cardiac controller may revert to a fault state if there are sufficient issues with therapy components. In the fault state, the cardiac controller may abort the vector sweeping therapeutic shocks and instead select two or more therapy components to provide simultaneous or sequential defibrillation to the patient using a predetermined waveform. For instance, the predetermined waveform may be a truncated exponential waveform.
[0152] As an example of the foregoing, vector sweep defibrillation was delivered to pigs as part of a study on the effectiveness of vector sweeping defibrillation schemes. The vector sweep defibrillation (VSD8) was configured as a defibrillation shock waveform including a counterclockwise sequence of eight electric current vectors spaced roughly evenly around the transverse axis of the pig torso. Electric currents were delivered with four metal electrodes with ECG gel placed on the skin and centered over the heart ventricles in the anterior, left lateral, posterior, and right lateral positions. To illustrate, the defibrillator shock waveform included the vectors A through -D shown in FIG. 4, delivered using electrodes positioned roughly as shown with respect to therapy components 502, but in a counterclockwise rather than a clockwise direction. Each electrode’s position over the heart ventricles was confirmed using fluoroscopy imaging in the vertical or horizontal plane. For vectors formed directly between two paired electrodes (e.g., vectors A, C, -A, and -C in FIG. 4), current flowed from one electrode to its opposite across the pig torso. For vectors formed diagonally betw een two sets of electrode pairs (e.g., vectors B. D, -B, and -D in FIG. 4), current flowed along a diagonal electric field vector oriented at an angle roughly halfway between that of the two-electrode direct vectors. Diagonal electric field vectors were generated by synchronizing shocks across tw o electrode pairs. Each electrode current vector lasted for a duration of 0.3125 ms for a total waveform duration of 2.5 ms. Each of the four electrodes generated an electric current by discharging its own capacitor of capacitance 64 pF. Energy was controlled using an open-loop algorithm for each shock by measuring the transthoracic impedance averaged across the tw oelectrode pairs, then setting the initial voltage equally for all four capacitors to estimate a waveform of the desired total energy.
[0153] To contrast with the vector sweeping defibrillation scheme, defibrillation shocks were also delivered using biphasic truncated exponential waveforms. The biphasic truncated exponential (BTE) waveforms were generated by discharging a single capacitor to deliver electric current across one electrode pair (phase 1), then discharging the same capacitor again to deliver electric current across the same electrode pair in the opposite direction (phase 2). Capacitance was 162.5 pF. Each of phase 1 and phase 2 lasted for a duration of 2.5 ms, and this duration was controlled using a closed-loop algorithm to deliver a shock of preset total energy. BTE shocks were delivered across the anterior-lateral electrode pair as described above. For example, with reference to FIG. 4, BTE shocks were delivered using therapy components 502a and 502c.
[0154] The total energy delivered by discharging one capacitor was calculated as the following, where C is the capacitance, Vmmai is the voltage measured between the current source and sink electrodes at the initial timepoint of capacitor discharge, Vfmai is the voltage measured between the current source and sink electrodes at the final timepoint of capacitor discharge:The total energy delivered by a shock waveform was calculated as the sum of the energies delivered by each capacitor discharge participating in the waveform. The BTE waveform consisted of a single capacitor discharged twice; thus, its total energy was calculated as (Ephasei + EPhase2). The VSD8 waveform consisted of three capacitors each discharged once and one capacitor discharged twice. Therefore, its total energy was calculated as (EcapiPhasei + Ecap2 + Ecapi + EcaP4 + Ecapiphase2). Energy7is presented in Table 1 below as mean energy7plus or minus a standard deviation.
[0155] For the study, ventricular fibrillation was induced by applying a direct electric current through a pacing catheter inserted through the pig’s right jugular vein and screwed into the wall of the right atrium. Each defibrillation attempt occurred after 45 s of ventricular fibrillation. Failed defibrillation attempts were followed by rescue shocks. To control for variation within each pig throughout the course of the experiment, a paired design was used in which the defibrillation waveform was alternated for each defibrillation attempt, but the energy was held constant. For example, defibrillation attempts for an individual pig could be structured as aV SD8 atempt at 45 J, followed by a BTE atempt at 45 J, followed by a V SD8 atempt at 45 J. followed by a BTE atempt at 45 J, etc. The energy was updated after every six defibrillation atempts to maximize the experiment’s statistical power by shocking at an intermediate energy most likely to distinguish the efficacy of two waveforms. A p-value was calculated using the 2-proportion z-test.
[0156] The results of the VSD8 versus BTE defibrillation shocks is summarized in Table 1 below. As shown, over the course of 52 defibrillation atempts for VSD8 and 51 defibrillation attempts for BTE, the success rate for VSD8 was 88.5% while the success rate for BTE was 15.7%, both with similar energy levels at 40.7 ± 5.0 J for VSD8 compared to 40.4 ± 5.0 J for BTE. This difference between the conversion rate for VSD8 versus BTE was statistically significant, with a p-value of 6 x 1013. Accordingly, the efficacy of vector sweep defibrillation can be very effective at lower energies, as demonstrated by these results.Wavefonn Pigs Defibrillation attempts Energy (J) Success rateTable 1: Results of a pig study comparing vector sweep defibrillation waveforms and biphasic truncated exponential waveforms.
[0157] In various embodiments, the wearable cardiac defibrillator 200 shown in FIG. 1A may be modified to create a wearable cardiac defibrillator beter capable of providing vector sweeping therapeutic shocks. Alternatively, other embodiments of a wearable cardiac defibrillator (e.g., the examples shown in FIGS. 16-18 and discussed below) can be modified to create a wearable cardiac defibrillator configured to provide vector sweeping therapeutic shocks. To illustrate, in implementations, the garment 208 of the wearable cardiac defibrillator 200 can be configured to support therapy components in any of the configurations described above. For example, the garment 208 can be modified to support therapy components in any of the configurations shown in FIGS. 2, 5, or 6. As such, the garment 208 may include additional and / or different enclosures or pockets to support additional therapy components from the embodiment shown in FIG. 1A. With reference to the configuration of FIG. 2, for instance, the garment 208 may be configured with an enclosure configured to be disposed at a front torso location of the patient (e.g., to house therapy component 302a), an enclosure configured to be disposed at a right side location of the patient (e.g., to house therapy component 302b), an enclosure configured to be disposed at a back torso location of the patient(e.g., to house therapy component 302c), and an enclosure configured to be disposed at a left side location of the patient (e.g.. to house therapy component 302d). An example of this configuration is shown in FIG. 7D, discussed in further detail below. Alternatively, the garment 208 may be modified such that therapy components 302 can be permanently attached or adhered to the garment 208 in the locations show n in FIG. 2.
[0158] FIGS. 7A-7H illustrate example placements for therapy components 700 on a garment 702 of the wearable cardiac defibrillator. These example placements may be accommodated, for example, by enclosures configured to receive the therapy components 700 and / or by permanent attachment to the garment 702. FIG. 7A shows example placements where therapy components 700a and 700b are configured to be positioned on front locations of the patient's torso and where therapy components 700c and 700d are configured to be positioned on a back location of the patient's torso. Similarly, FIG. 7B shows example placements where therapy components 700e and 700f are configured to be positioned on front locations of the patient's torso and where therapy components 700g and 700h are configured to be positioned on a back locations of the patient’s torso (e.g., closer to the sagittal plane of the patient 104 compared to the position of the therapy components 700c and 700d as shown in FIG. 7A). FIG. 7C shows example placements where therapy components 700i, 700j, 700k, and 700m are all configured to be positioned on front portions of the patient’s torso, with therapy components 700k and 700m positioned superior to therapy components 700i and 700j. FIG. 7D shows example placements where therapy component 700n is configured to be positioned on a front location on the patient’s torso, therapy component 700p is configured to be positioned on a back location of the patient’s torso, therapy component 700q is configured to be positioned on a right side location of the patient’s torso, and therapy component 700u is configured to be positioned on a left side location of the patient’s torso. For example, the therapy component 700q can be placed substantially about a middle axillary line on the right side of the patient. As another example, the therapy component 700u can be placed substantially about a middle axillary line on the left side of the patient. FIG. 7E shows example placements w here therapycomponents 700v and 700w are configured to be positioned on front locations of the patient’s torso and therapy components 700x and 700y are configured to be positioned on back locations of the patient’s torso inferior to the therapy components 700v and 700w.
[0159] FIG. 7F shows example placements where therapy components 700z and 700aa are configured to be positioned on a right side portion of the patient’s torso (e.g., where therapy components 700z and 700aa are placed side-by-side on the right side locations) and therapy components 700bb and 700cc are configured to be positioned on a left side locations of thepatient's torso inferior to the therapy components 700z and 700aa (e g., where therapy components 700bb and 700cc are placed side-by-side on the patient’s left side locations). For example, the therapy components 700z and 700aa can be placed on either side about a middle axillary line on the right side of the patient. As another example, the therapy components 700bb and 700cc can be placed on either side about a middle axillary7line on the left side of the patient. FIG. 7G shows example placements where therapy component 7OOdd is configured to be positioned on aright side location of the patient’s torso, therapy component 700ee is configured to be positioned on a left side location of the patient’s torso, and therapy7components 700ff and 700gg are configured to be positioned on a back locations of the patient’s torso. FIG. 7H shows example placements where therapy components 700hh and 700ii are configured to be positioned on front locations of the patient’s torso, therapy components 700jj and 700kk are configured to be positioned against back locations of the patient’s torso, therapy component 700mm is configured to be positioned again a right side location of the patient’s torso, and therapy component 700nn is configured to be positioned against a left side location of the patient's torso. For example, the therapy component 700mm can be placed substantially about a middle axillary line on the right side of the patient. As another example, the therapy component 700nn can be placed substantially about a middle axillary line on the left side of the patient.
[0160] In implementations, the garment 702 is configured to receive the therapy components 700 in the positions shown in FIGS. 7A-7H. As an illustration, the garment 702 may include enclosures such as pockets configured to receive the therapy components 700 as shown in FIGS. 7A-7H. Thus, for the positions shown in FIGS. 7A, 7B, and 7E, the garment 702 may include two pockets configured to be positioned against front locations of the patient’s torso and configured to receive therapy components 700a and 700b in FIG. 7A. therapy components 700e and 700f in FIG. 7B, or therapy components 700v and 700w in FIG. 7E. The garment 702 may also include two pockets configured to be positioned against back locations of the patient’s torso and configured to receive therapy components 700c and 700d in FIG. 7A, therapy components 700g and 700h in FIG. 7B, or therapy components 700x and 700y in FIG. 7E. For the positions shown in FIG. 7C, the garment 702 may include two pockets configured to be positioned front locations of the patient’s torso and configured to receive therapy components 700i and 700j. The garment 702 may additionally include two pockets configured to be positioned against front locations of the patient’s torso superior to the therapy components 700i and 700j and configured to receive therapy components 700k and 700m.
[0161] For the positions shown in FIG. 7D, the garment 702 may include a pocket configured to be positioned against a front location of the patient’s torso and configured to receive therapy component 700n, a pocket configured to be positioned against a back location of the patient’s torso and configured to receive therapy component 700p, a pocket configured to be positioned against a right side location of the patient’s torso and configured to receive therapy component 700q, and a pocket configured to be positioned against a left side portion of the patient’s torso and configured to receive therapy component 700u. For the positions shown in FIG. 7F. the garment 702 may include two pockets configured to be positioned against right side locations of the patient’s torso and configured to receive therapy components 700z and 700aa and two pockets configured to be positioned against left side locations of the patient’s torso and configured to receive therapy components 700bb and 700cc. For the positions shown in FIG. 7G. the garment 702 may include pockets configured to be positioned against back locations of the patient’s torso and configured to receive therapy components 700ff and 700gg, a pocket configured to be positioned against a right side location of the patient's torso and configured to receive therapy component 700dd, and a pocket configured to be positioned against a left side location of the patient’s torso and configured to receive therapy component 700ee. For the positions shown in FIG. 7H, the garment 702 may include pockets configured to be positioned against front locations of the patient’s torso and configured to receive therapy components 700hh and 700ii, pockets configured to be positioned against back locations of the patient’s torso and configured to receive therapy components 700jj and 700kk, a pocket configured to be positioned against a right side location of the patient’s torso and configured to receive therapy component 700mm, and a pocket configured to be positioned against a left side location of the patient’s torso and configured to receive therapy component 700nn.
[0162] In implementations, the therapy component placements may be selected to account for male and female anatomy. For example, the electrode placements shown in FIGS. 7C and 7E including therapy components 700 placed against an upper front locations of the patient’s torso may be used for male patients. The placement of the upper front therapy components 700 may be adjusted for female patients to avoid interference from breast tissue. As an illustration, the upper front location therapy components 700 may be raised or moved to the patient’s sides to avoid being placed on top of the patient’s breast tissue. In implementations, other positions of the therapy components 700 may alternatively be used. For example, in implementations, the garment 702 may be configured to receive fewer than four or more than four therapy components 700. such as the six therapy component 700 configuration shown in FIG. 7H.
[0163] In implementations, a wearable cardiac defibrillator electrically configured similarly to the wearable cardiac defibrillator 200 of FIGS. 1A and IB may provide vector sweeping therapeutic shocks to a patient. Such a wearable cardiac defibrillator may include a number of electrode components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient. For example, at least some of the electrode components may be configured to receive and process sensed surface electrical activity of the patient (e.g., configured similarly to the sensing electrodes 204). As another example, at least some of the electrode components may be configured to provide successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the patient’s torso (e.g., configured similarly to the therapy electrodes 206). The wearable cardiac defibrillator may include a cardiac controller (e.g., configured similarly to the cardiac controller 214 and 250) configured to be operably connected to the electrode components. The cardiac controller may thus monitor ECG signals generated from the sensed surface electrical activity' of the patient, detect that the patient is experiencing a treatable cardiac arrhythmia, and control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the patient’s torso.
[0164] In implementations, additional modifications to the wearable cardiac defibrillator 200 shown in FIGS. 1 A and IB (or other embodiments of a wearable cardiac defibrillator, such as the examples shown in FIGS. 16-18 and discussed below) to provide vector sweeping therapeutic shocks to a patient. For example, components of the wearable cardiac defibrillator 200, such as the sensing electrodes 204, therapy electrodes 206, the signal processing node 210, the patient interface pod 212, and / or additional sensors or detectors, may be combined to better disperse the components across the wearable cardiac defibrillator 200. As another example, some or all of the functionality of the cardiac controller 214 (e.g., some or part of the electronic architecture of the cardiac controller 250 shown in FIG. IB, as discussed above) may be moved outside of the cardiac controller 214 to one or more other components of the wearable cardiac defibrillator 200. By moving portions of the cardiac controller 214 into other components of the wearable cardiac defibrillator 200, the size and weight of the cardiac controller 214 may be decreased. In some cases, the cardiac controller 214 may be eliminated entirely. A smaller or removed cardiac controller 214 may allows for a wearable cardiac defibrillator 200 that is easier and more comfortable to w ear, thus improving the chance that the patient 202 will use the wearable cardiac defibrillator 200 throughout the prescription, in addition to better configuring the wearable cardiac defibrillator 200 to deliver vector sweeping therapeutic shocks.
[0165] For example, in implementations, the electrode components of a wearable cardiac defibrillator may include a number of combined ECG and therapy components. The combined ECG and therapy components are configured to be disposed at predetermined, spaced-apart, anatomical locations to deliver vector sweeping shocks to the patient, e.g., in the form of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors, as discussed above. Additionally, each combined ECG and therapy components include circuitry and other hardware configured to both sense surface electrical activity of the patient and deliver one or more of the successive therapeutic shocks.
[0166] FIG. 8 illustrates an example electronic architecture 800 for a wearable cardiac defibrillator that includes combined ECG and therapy components. More specifically, the example electronic architecture 800 includes a cardiac controller 801. a signal processing node 820, a first combined ECG and therapy component 840a, a second combined ECG and therapy component 840b, a third combined ECG and therapy component 840c, and a fourth combined ECG and therapy component 840d (collectively, combined ECG and therapy components 840). Referring first to the cardiac controller 801. as shown in FIG. 8, the cardiac controller 801 is generally configured to monitor ECG signals of the patient (e.g.. generated from sensed surface electrical activity of the patient from the combined ECG and therapy components 840, as discussed with reference to FIG. IB), detect that the patient is experiencing a treatable cardiac arrhythmia, and control delivery of the successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient (e.g., via the combined ECG and therapy components 840, as also discussed in further detail below).
[0167] Implementations of the cardiac controller 801 may include at least one battery' 802, at least one response button 804, a cell module 806, a display 808, a belt connector 810, a cell antenna 812. a speaker 814. a main printed circuit board assembly (PCBA) 816, and a nonvolatile data storage 818. The at least one battery 802 is configured to power the other parts of the cardiac controller 801. The battery or batteries 802 may be configured to be removable from the cardiac controller 801 such that the battery' or batteries 802 can be recharged. In implementations, the at least one battery 802 may be configured similarly to the at least one battery 262 of FIG. IB described above. The display 808 and speaker 814 serve as user interfaces (e.g., similar to the user interface(s) 260 of FIG. IB) that the cardiac controller 801 can use to communicate information to the patient or a healthcare provider and / or receive inputs from the patient or healthcare provider. For instance, the display 808 may communicate settings to a healthcare provider, such as a technician, and receive settings selections via a touchscreen. As another example, the cardiac controller 801 may use the speaker 814 to providean auditory alert to the patient, warning the patient that the cardiac controller 801 has detected the patient is experiencing a treatable cardiac arrhythmia. The patient may then indicate that the patient is still conscious by pressing the one or more response buttons 804 provided on the cardiac controller, as discussed above with reference to FIGS. 1A and IB. In response to the patient pressing the one or more response buttons 804, the cardiac controller 801 may delay or abort the delivery of the successive therapeutic shocks. The belt connector 810 may be configured to be removably connected to a therapy belt that includes other electronic components of the wearable cardiac defibrillator. In the example of FIG. 8, the therapy belt may include the signal processing node 820 and the combined ECG and therapy components 840.
[0168] The cell module 806 and the cell antenna 812 together serve as a network interface configured to communicate, for example, with a remote server via cellular networks. In other examples, the cardiac controller 801 may communicate with a remote server via other types of wireless communication protocols, such as via Wi-Fi or via Bluetooth® to a local hub that serves as an intermediary’ between the cardiac controller 801 and the remote server (e.g., with the local hub communicating using cellular networks or Wi-Fi). The cardiac controller 801 may transmit information to the remote server, such as ECG signals of the patient, and / or receive information from the remote server, such as system updates. In implementations, the cell module 806 and the cell antenna 812 may be configured similarly to the network interface 258 of FIG. IB. described above. The information received by the cardiac controller (e.g., processed signals relating to the patient, inputs from the patient and / or healthcare provider, information from the remote server, etc.) may be stored in the non-volatile data storage 818. In implementations, the non-volatile data storage 818 may be configured similarly to the data storage 256 discussed above with reference to FIG. IB. The main PCBA 816 includes one or more processors configured to implement the functionalities of the cardiac controller 801 , such as be executing instructions maintained on the non-volatile data storage 818. The main PCBA 816 may be configured to, for instance, detect whether the patient is experiencing a treatable arrhythmia condition, activate one or more patient alerts in response to determining that the patient is experiencing a treatable arrhythmia condition, and control the delivery of the vector sweeping therapeutic shocks to treat the arrhythmia condition In implementations, the main PCBA 816 is implemented similarly and / or can implement at least some of the functions of the at least one processor 270 of FIG. IB, discussed above (e.g., the main PCBA 816 can implement some or all of the functions of the cardiac event detector 264. alarm manager 266, sensor interface 254, and / or motion sensor interface 278).
[0169] Alternatively, in implementations, the cardiac controller 801 may not include, e.g., the display 808, cell module 806, cell antenna 812, and main PCBA 816. Instead, the cardiac controller 801 may include, for instance, a simpler PCBA more similar to the secondary PCBA 824 discussed below. The display 808, cell module 806, cell antenna 812, and at least part of the main PCBA 816 may instead be located in a hub configured to communicate locally with the cardiac controller 801, such as by Bluetooth® wireless protocols. As an example, the hub may be configured as a cell phone that the patient is asked to carry with them throughout their day.
[0170] The signal processing node 820 is configured to be operably coupled to other components of the wearable cardiac defibrillator. For example, as shown in FIG. 8, the signal processing node 820 may be operably coupled to the cardiac controller 801 and the combined ECG and therapy components 840. Implementations of the signal processing node 820 may include short-circuit protection (SCP) and high-voltage protection (HVP) circuits 822, a secondary PCBA 824, a microcontroller 826, a tactile alarm mechanism 830, and a high- voltage (HV) capacitor charging circuit 832. The tactile alarm mechanism 830 is configured to deliver one or tactile alarms to the patient, such as before the delivery of successive therapeutic shocks by the combined ECG and therapy components 840. For example, the tactile alarm mechanism 830 may include a tactile motor that is configured to vibrate when activated. In implementations, the signal processing node 820 may be configured to lie against the small of the patient’s back (e.g., with a garment of the wearable cardiac defibrillator associated with the signal processing node 820 configured to support the signal processing node in position against the small of the patient’s back). When the cardiac controller 801 determines that the patient is experiencing a treatable arrhythmia condition, the main PCBA 816 may transmit a signal to the signal processing node 820 to activate the tactile alarm mechanism 830 as part of alerting the patient of the detected arrhythmia condition. With the signal processing node 820 supported against the small of the patient’s back, the patient may be able to feel the vibrations of the tactile alarm mechanism 830 even when the patient does not notice other alarms of the wearable cardiac defibrillator, such as auditory alarms emitted by the speaker 814 because the patient is in a loud area.
[0171] The HV capacitor charging circuitry 832 is configured to charge capacitors (e.g., defibrillation capacitors 852, described below) on the combined ECG and therapy components 840. For instance, when the cardiac controller 801 detects a treatable arrhythmia condition in the patient, the main PCBA 816 may also transmit a signal to the HV capacitor charging circuitry 832 to initiate capacitor charging in preparation for delivering therapeutic shocks tothe patient. In implementations, the HV capacitor charging circuitry 832 may draw energy from the at least one batten’ 802 of the cardiac controller 801 to charge the capacitors. In implementations, the signal processing node 820 may include a secondary battery or other power source electrically connected to the HV capacitor charging circuitry 832 and from which the HV capacitor charging circuitry 832 draws energy to charge the capacitors. In implementations, when charging the capacitors, the HV capacitor charging circuitry 832 may cycle through each capacitor to be charged to help ensure uniform or mostly uniform charging and thus energy levels of the capacitors while the wearable cardiac defibrillator is preparing to shock the patient.
[0172] The SCP / HVP circuits 822 may be configured to protect the rest of the circuitry and electronic parts of the signal processing node 820 from being accidentally damaged by, for example, the HV capacitor charging circuitry 832. As such, the SCP / HVP circuits 822 may be able to redirect current away from the other circuits and electronic parts of the signal processing node 820 and dissipate the redirected current. In implementations, the HV capacitor charging circuitry 832 and the SCP / HVP circuits 822 may be configured to have at least some of the functionality of the therapy delivery circuit 268 of FIG. IB. discussed above.
[0173] The secondary PCBA 824 and the microcontroller 826 are configured to implement the functionalities of the signal processing node 820 described above. In implementations, the second PCBA 824 may include circuity that includes at least some of the SCP / HVP circuits 822 and / or the HV capacitor charging circuitry 832. In implementations, the microcontroller may include at least one processor and at least one non-volatile memory configured to store instructions executable by the at least one processor to implement the functions of the signal processing node 820.
[0174] In implementations, the wearable cardiac defibrillator configured to provide vector sweeping therapeutic shocks to a patient includes a driven ground electrode, as described above with reference to FIG. 1A. In examples, the driven ground electrode may be combined with another component of the wearable cardiac defibrillator. For instance, in the example of FIG. 8, the signal processing node 820 may further include a driven ground electrode 828. As discussed above, the driven ground electrode 828 may be configured to transmit a high- frequency signal (e.g., generated at the signal processing node 820) into the patient. The high- frequency signal can be sensed by, for example, the combined ECG and therapy components 840, and the wearable cardiac defibrillator (e.g., at the cardiac controller 801 and / or the signal processing node 820) can use whether a given combined ECG and therapy component 840 has fallen off from the patient’s skin. In implementations, the circuitry for the driven groundelectrode 828 may be located at the signal processing node 820, which the electrode surface for the driven ground electrode 828 may be located elsewhere. For example, the electrode surface for the driven ground electrode 828 may be one or more of the therapy electrode surfaces on the combined ECG and therapy components 840. As another example, the electrode surface for the driven ground electrode 828 may be a separate electrode surface on one of the combined ECG and therapy components 840. In implementations, the signal processing node 820 may include the circuitry for the driven ground electrode 828. as well as the driven ground electrode surface.
[0175] In implementations, the driven ground electrode 828 may be configured to be electrically isolated from the successive therapeutic shocks that may be delivered by the combined ECG and therapy components 840. For example, the driven ground electrode 828 may be electrically isolated through an electrical switch that can be activated (e.g., by the microcontroller 826 when the microcontroller 826 activates the HV capacitor charging circuitry 832, by the main PCBA 816 when the main PCBA 816 controls the deliver}' of the therapeutic shocks, etc.) to redirect excess therapeutic energy away from the driven ground electrode 828. As another example, the driven ground electrode 828 may be electrically isolated through a shunt circuit forming a low-resistance path to redirect excess energy away from the driven ground electrode 828. As another example, the driven ground electrode 828 may be configured with a high resistance. For instance, the driven ground electrode 828 may include a high- resistance electrode surface configured to contact the patient’s skin, where the high resistance of the electrode surface helps prevent therapeutic energy from shorting out the driven ground electrode 828.
[0176] In implementations, each combined ECG and therapy component 840 may include a combined ECG and therapy component housing. Each combined ECG and therapy component 840 may also include an ECG sensing circuit 850, one or more defibrillation capacitors 852, and a therapy delivery circuit 856 disposed within the combined ECG and therapy component housing. In implementations, a microcontroller 854 may further be disposed within the combined ECG and therapy component housing, where the microcontroller 854 includes at least one processor and at least one non-volatile memory configured to store instructions executable by the at least one processor to implement the functions of the combined ECG and therapy component 840.
[0177] The ECG sensing circuit 850 is configured to receive and process sensed surface electrical activity of the patient. In implementations, each combined ECG and therapy component may further include one or more electrode surfaces. The combined ECG andtherapy component housing may be mechanically coupled to the one or more electrode surfaces. Additionally, the one or more electrode surfaces may be configured to sense the surface electrical activity of the patient. The ECG sensing circuit 850 may be electrically connected to at least one electrode surface to receive the sensed surface electrical activity. The ECG sensing circuit 850 may further process the sensed surface electrical activity, for example, to digitize the sensed surface electrical activity into digital ECG signals, to remove noise from the sensed surface electrical activity, and / or the like. In implementations, the ECG sensing circuit 850 may perform at least some of the functions of the sensor interface 254 discussed above with respect to FIG. IB.
[0178] The one or more defibrillation capacitors 852 are configured to store electric energy. For example, the one or more defibrillation capacitors 852 may receive energy from the HV capacitor charging circuitry 832 of the signal processing node 820 in preparation for delivering successive therapeutic shocks to the patient. In implementations, the one or more defibrillation capacitors 852 may be configured similarly to the one or more capacitors discussed above with reference to the therapy delivery circuit 268 of FIG. IB. However, in implementations, the one or more defibrillation capacitors 852 may be smaller than the one or more capacitors discussed above. The smaller size may be due to each combined ECG and therapy component 840 having its own defibrillation capacitor(s) 852, as w ell as potentially low er voltage requirements for delivering vector sweeping therapeutic shocks to the patient compared to multiphasic therapeutic shocks discussed with respect to the wearable cardiac defibrillator 200 and the cardiac controller 250 of FIGS. 1 A and IB. For example, a defibrillation capacitor 852 may be a 1200 V, 50 pF capacitor about 15 mm thick. As another example, a defibrillation capacitor 852 may be around 9 cubic inches in volume. As another example, the defibrillation capacitors 852 may include multiple capacitors each around 1 cubic inch in volume.
[0179] Each therapy deliver}' circuit 856 is configured to deliver one or more of the successive therapeutic shocks (e.g., the successive therapeutic shock or shocks associated with the particular combined ECG and therapy component 840) using the stored electric energy of the one or more defibrillation capacitors 852. For example, the therapy delivery circuit 856 may receive signals from the cardiac controller 801 (e.g.. via the signal processing node 820) instructing the therapy delivery circuit 856 when to deliver therapeutic shocks and how much energy to deliver in each shock. In this way, each therapy deliver ' circuit 856 may also be configured to perform some of the functionality of the therapy delivery circuit 268 of FIG. IB.
[0180] The one or more electrode surface may be further configured to deliver the one or more of the successive therapeutic shocks to the patient. As such, the one or more electrodesurfaces may be electrically coupled to the one or more defibrillation capacitors 852 and the therapy delivery circuit 856. In implementations, a combined ECG and therapy component 840 may include a single electrode surface, where the same electrode surface is used to sense surface electrical activity of the patient and deliver the one or more therapeutic shocks. In implementations, a combined ECG and therapy component 840 may include multiple electrode surfaces. At least one of the electrode surfaces may be an ECG sensing electrode surface configured to sense the patient’s surface electrical activity, and at least one of the electrode surface may be a therapy delivery electrode surface configured to deliver the one or more therapeutic shocks. For example, the ECG sensing electrode surface(s) may have a smaller area than the therapy delivery electrode surface(s) due to the therapy delivery' electrode surface(s) needing a larger area by which to deliver the therapeutic shocks to avoid concentrating the therapeutic energy and damaging the patient’s skin. In implementations, the surface electrical activity7sensed by the combined ECG and therapy components 840 may by processed (e.g., at the signal processing node 820, at the cardiac controller 801, etc.) to generate various ECG leads by combining the signals differently in the software. As such, instead of two ECG leads for four combined ECG and therapy components 840, the wearable cardiac defibrillator may have three or more ECG leads, which in turn may allow for better detection of the patient’s heart rate, arrhythmias, etc.
[0181] In implementations, and as shown in FIG. 8. each combined ECG and therapy component 840 may include a gel deployment circuit 858 and one or more gel deployment devices 860 configured to store one or more doses of conductive gel. The one or more doses of conductive gel may be stored, for example, in a gel pack that is removable from the combined ECG and therapy component 840 or permanently integrated into the combined ECG and therapy component. The gel may be configured to increase conductivity between a skin surface of the patient and the respective combined ECG and therapy component before the delivery of the successive therapeutic shocks. As such, the one or more gel deployment devices 860 may be located near the one or more electrode surfaces configured to deliver the one or more of the successive therapeutic shocks. In implementations, the gel may be configured similarly to the electrolytic gel described above with reference to FIG. 1 A. The gel deployment circuit 858 is configured to release the one or more doses of conductive gel before the delivery of the successive therapeutic shocks. For instance, the gel deployment circuit 858 may receive a signal (e.g., from the therapy delivery circuit 856, from the microcontroller 826 of the signal processing node, etc.) indicating that therapeutic shocks are about to be delivered to the patient. In response to the signal, the gel deployment circuit 858 may activate to release the gel fromthe one or more gel deployment devices 860 (e.g., by releasing fluid that forces the gel out of gel storage components of the one or more gel deployment device 860 and onto the patient's skin).
[0182] The wearable cardiac defibrillator may further include other components described herein with reference, for example, to the wearable cardiac defibrillator 200 of FIGS. 1A and IB. the wearable cardiac defibrillator of FIG. 16 including a hospital wearable defibrillator 1600, the wearable cardiac defibrillator of FIG. 17 including an adhesive assembly 1700. the wearable cardiac defibrillator of FIG. 18 including a belted wearable defibrillator 1800, etc. In implementations, the wearable cardiac defibrillator including the electronic architecture 800 of FIG. 8 may also include a garment. In examples, the garment may be similar to the garment 208 of FIG. 1A and be configured to support, for example, the combined ECG and therapy components 840 at their respective predetermined, spaced-apart, anatomical locations on the patient. The combined ECG and therapy components 840 may be removably assembled into the garment, or the combined ECG and therapy components 840 may be permanently- integrated into the garment. For example, the combined ECG and therapy components 840 may be inserted into pockets or other enclosures of the garment, snapped onto the garment, attached to the garment with hook-and-loop fasteners, etc., as discussed above with reference to the garment 208 of FIG. 1 A. As another example, the combined ECG and therapy components 840 may be sewn into the garment or permanently adhered to the garment, as also discussed above with reference to the garment 208.
[0183] In examples, the garment may be configured to support the cardiac controller 801. For instance, the cardiac controller 801 may be small enough to clip into the garment, snap into the garment, be inserted into a pocket or other enclosure of the garment, and / or the like (e.g., especially if at least some of the components of the cardiac controller 801 are moved to a local hub, as also discussed above). Otherwise, the cardiac controller may be integrated into the garment, such as integrated into the overall garment structure. In implementations, the garment includes a belt configured to be worn around a patient’s torso and shoulder straps connected to the belt, where the shoulder straps are configured to be worn over the patient’s shoulders. Accordingly, the garment may look similar to the garment 208 shown in FIG. 1A. In implementations, the garment may include just the belt configured to be worn about the patient's torso. In such implementations, for instance, the cardiac controller 801 may be supported by or integrated into the belt and connected to adhesive electrode components (e.g., similar to the hospital wearable defibrillator 1600 shown and described below with referenceto FIG. 16 and / or the belted wearable defibrillator 1800 shown and described below with reference to FIG. 18).
[0184] In implementations, at least some of the combined ECG and therapy components 840 may be configured to be adhesively attached to a skin surface of the patient at predetermined, spaced-apart, anatomical locations. In implementations, the wearable cardiac defibrillator may include one or more adhesive patches configured to be removably attached to a skin surface of the patient. In such implementations, the cardiac controller 801 may be configured to be supported by at least one of the one or more adhesive patches (e.g., similar to the adhesive assembly 1700 shown and described below' with reference to FIG. 17). Alternatively, or additionally, the combined ECG and therapy components 840 may be configured to be supported by at least one of the one or more adhesive patches in such embodiments.
[0185] FIG. 9 illustrates another example electronic architecture 900 for a wearable cardiac defibrillator that includes combined ECG and therapy components. The example electronic architecture 900 includes a cardiac controller 901 , a signal processing node 902, a user response unit 904, and combined ECG and therapy components 840 (e.g., similar to the combined ECG and therapy components 840 shown in FIG. 8). Similar to the cardiac controller 801 of FIG. 8. the cardiac controller 901 includes one or more batteries 802, a cell module 806, a display 808, a cell antenna 812, a speaker 814, and a main PCBA 816. In implementations, the display 808, cell module 806. cell antenna 812, and / or part of the main PCBA 816 may alternatively be moved to an intermediate hub. However, the non-volatile data storage 818 is instead included in the signal processing node 902.
[0186] Additionally, the one or more response buttons 804 may instead be included as part of a user response unit 904. For example, the user response unit 904 may be provided on a trunk cable of the therapy belt. As another example, the user response unit 904 may be configured as a separate component configured to be attached, for instance, to a garment of a wearable cardiac defibrillator or to the patient’s clothes. Accordingly, the user response unit 904 may be configured similarly to the patient interface pod 212 shown in FIG. 1A. In implementations, the user response unit 904 may further include the belt connector 810 (e.g., such that the therapy belt attaches into the user response unit 904). The user response unit 904 is configured to be operably coupled to the cardiac controller 901, e.g., via a permanent or removable attachment. Additionally, as shown, the signal processing node 902 is configured to be operably coupled to the user response unit 904 in addition to the cardiac controller 901 and the combined ECG and therapy components 840. In examples, the user response unit 904 may be permanently connected to the cardiac controller 901 and removably connectable from thesignal processing node 902 (e.g., via the belt connector 810). In examples, the user response unit 904 may be removably connected to the cardiac controller 901 and / or to the signal processing node 902.
[0187] Such modifications may have the further impact of shrinking the size of the cardiac controller 901 further such that the cardiac controller 901 is easier and more comfortable for the patient to wear. In implementations, the cardiac controller 901 may be small enough to be assembled into a garment of a wearable cardiac defibrillator including the electronic architecture 900.
[0188] FIG. 10 illustrates another example electronic architecture 1000 for a wearable cardiac defibrillator that includes combined ECG and therapy components. The example electronic architecture 1000 includes a cardiac controller 1001, a signal processing node 1002, and combined ECG and therapy components 840 (e.g., similar to the combined ECG and therapy components 840 shown in FIG. 8). The cardiac controller 1001 and signal processing node 1002 are generally configured similarly to the cardiac controller 801 and signal processing node 820 of FIG. 8, except that the HV capacitor charging circuitry’ 832 configured to charge the defibrillation capacitors 852 of the combined ECG and therapy components 1102 is included in the cardiac controller 1001 instead of in the signal processing node 1002. As such the cardiac controller 1001 is configured to charge the defibrillation capacitors 852 of the combined ECG and therapy components 840 (e.g., with the signal processing node 1002 serving as an intermediary to deliver the energy to be stored in the defibrillation capacitors 852).
[0189] FIG. 11 illustrates another example electronic architecture 1100 for a wearable cardiac defibrillator that includes combined ECG and therapy components. As shown, the example electronic architecture 1100 include a cardiac controller 801 (e.g., configured similarly to the cardiac controller 801 of FIG. 8), a signal processing node 820 (e.g., configured similarly to the signal processing node 820 of FIG. 8), a first combined ECG and therapy component 1102a, and a second combined ECG and therapy component 1102b (collectively, combined ECG and therapy components 1102). As shown in FIG. 11, the combined ECG and therapy components 1102 are generally configured similarly to the combined ECG and therapy components 840 shown in FIG. 8. However, each of the combined ECG and therapy components 1102 includes a first ECG sensing circuit 850a and a second ECG sensing circuit 850b. Both ECG sensing circuits 850a and 850b are disposed within the combined ECG and therapy component housing and configured to receive and process sensed surface electrical activity7of the patient (e.g., similar to the ECG sensing circuit 850 of FIG. 8). Inimplementations, the one or more electrode surfaces of each combined ECG and therapy component 1102 may include two (or more) ECG sensing electrode surfaces, each configured to sense surface electrical activity of the patient. One or more of the ECG sensing electrode surfaces is electrically connected to the first ECG sensing circuit 850a, and the remaining ECG sensing electrode surface(s) is electrically connected to the second ECG sensing circuit 850b. As an example, FIG. 14D illustrates an embodiment of a combined ECG and therapy component 1460 that includes multiple ECG sensing electrode surfaces 1462b and 1462b that may be respectively electrically connected to a first ECG sensing circuit and a second ECG sensing circuit. In implementations, the first ECG sensing circuit 850a may correspond to a different ECC channel than the second ECG sensing circuit 850b. For example, the first ECG sensing circuits 850a of the combined ECG and therapy components 1102a and 1102b may be part of a first ECG channel, and the second ECG sensing circuits 850b of the combined ECG and therapy components 1102a and 1102b may be part of a second ECG channel. In implementations, the first ECG sensing circuit 850a and the second ECG sensing circuit 850a may instead be part of the same ECG channel.
[0190] In implementations, as further shown in FIG. 11, the electronic architecture 1100 of a wearable cardiac defibrillator may include one or more therapy electrodes that are separate from the combined ECG and therapy components 1102. In the example electronic architecture 1100, the wearable cardiac defibrillator includes a first separate therapy electrode 1104 and a second separate therapy electrode 1104b (collectively, therapy electrodes 1104). Each therapy electrode 1 104 is configured to deliver one or more of the successive therapeutic shocks of the vector sweeping therapy. Additionally, each therapy electrode 1104 is configured to be disposed at predetermined, spaced-apart, anatomical locations (e.g., similar to the combined ECG and therapy components 1102) such that the combined ECG and therapy components 1 102 along with the therapy electrodes 1104 are configured to provide the successive therapeutic shocks in the rotational sequence of therapy vectors traversing the torso of the patient. As an example, the combined ECG and therapy components 1102 may be configured to be disposed at front torso locations of the patient, and the separate therapy electrodes 1104 may be configured to be disposed at back torso locations of the patient (e.g., because the back torso locations generate too much noise for the ECG sensing functionalities of the combined ECG and therapy components 1102).
[0191] In implementations, each of the therapy electrodes 1104 may be configured similarly to the combined ECG and therapy components 1102. For example, each of the therapy electrodes 1104 may include some or more of the circuitry and electronic parts of the ECG andtherapy components. As an example, each of the therapy electrodes 1104 may include one or more electrode surfaces (e.g., configured only for delivering the one or more of the successive therapeutic shocks associated with the respective therapy electrode 1 104), a therapy electrode housing mechanically coupled to the one or more electrode surfaces, and one or more defibrillation capacitors 852 disposed within the therapy electrode housing and configured to store electric energy. As another example, each of the therapy electrodes 1104 may additionally include a therapy delivery circuit 856 disposed within the therapy electrode housing and configured to deliver the one or more of the successive therapeutic shocks associated with the respective therapy electrode 1104 using the stored energy from the one or more defibrillation capacitors 852. As another example, each of the therapy electrodes 1104 may include a microcontroller 854. As another example, each of the therapy electrodes 1104 may be configured similarly to the combined ECG and therapy components 1 102 but without the ECG sensing parts (e.g., not including the ECG sensing circuit 850 and only including one or more electrode surfaces used for delivering therapeutic shocks). Accordingly, as shown in FIG. 11, each of the therapy electrodes 1104 may further include a gel deployment circuit 858 and one or more gel deployment devices 860.
[0192] FIG. 12 illustrates another example electronic architecture 1200 for a wearable cardiac defibrillator that includes combined ECG and therapy components. As shown, the example electrode architecture more specifically includes a cardiac controller 801 (e.g., configured similarly to the cardiac controller 801 of FIG. 8), a signal processing node 1202, combined ECG and therapy components 840 (e.g., configured similarly to the combined ECG and therapy components 840 shown in FIG. 8), separate therapy electrodes 1204, a first separate ECG sensing electrode 1206a, and a second ECG sensing electrode 1206b (collectively. ECG sensing electrodes 1206). As shown, the signal processing node 1202 is configured similarly to the signal processing node 820 of FIG. 8, except that the driven ground electrode 828 and the tactile alarm mechanism 830 have been moved out of the signal processing node 1202. In implementations, the first therapy electrode 1204a instead includes the driven ground electrode 828. For example, the first therapy electrode 1204a may include one or more driven ground electrode surfaces configured to deliver driven ground signals to the patient. These one or more driven ground electrode surfaces may be the same electrode surface(s) that the first therapy electrode 1204a uses to deliver therapeutic shocks to the patient, or these one or more driven ground electrode surfaces may include one or more electrode surfaces in addition to the electrode surface(s) used for therapeutic shocks. The first therapy electrode 1204a may receive the driven ground signals, for instance, from the signal processingnode 1202 or the cardiac controller 801. Alternatively, the first therapy electrode 1204a may generate the driven ground signals, e.g., using the microcontroller 854. In implementations, the second therapy electrode 1204b may include the tactile alarm mechanism 830, as further shown in FIG. 12. Thus, the second therapy electrode 1204b may receive signals from the cardiac controller 801 (e.g., via the signal processing node 1202) to activate the tactile alarm mechanism 830 in response to the cardiac controller 801 detecting that the patient is experiencing a treatable arrhythmia condition, as discussed above with respect to FIG. 8.
[0193] The separate ECG sensing electrodes 1206 are configured to sense the patient’s surface electrical activity. As such, each of the ECG sensing electrodes 1206 may include one or more ECG sensing electrode surfaces. Further, as shown in FIG. 12, each of the ECG sensing electrodes 1206 may include an ECG sensing circuit 850 configured to receive and process the sensed surface electrical activity’ (e.g., to generate digitized ECG signals, remove noise from the sensed surface electrical activity, and / or the like). In implementations, the combined ECG and therapy components 840 are configured to be disposed at predetermined, spaced-apart anatomical locations on the front torso of the patient. Conversely, the separate therapy electrodes 1204 may be configured to be disposed on back torso locations of the patient, and the separate ECG sensing electrodes 1206 may be configured to be disposed on additional back torso locations of the patient. Such configurations may allow, e.g., for better sensing of surface electrical activity on the patient's back torso with less noise.
[0194] FIG. 13 illustrates another example electronic architecture 1300 for a wearable cardiac defibrillator that includes combined ECG and therapy components. The example electronic architecture 1300 includes a cardiac controller 801 (e.g., configured similarly to the cardiac controller 801 of FIG. 8), a signal processing node 1302, combined ECG and therapy components 840 (e.g.. configured similarly to the combined ECG and therapy components shown in FIG. 8), a first therapy electrode 1204a (e.g., configured similarly to the first therapy electrode 1204a of FIG. 12), a second therapy electrode 1204b (e.g., configured similarly to the second therapy electrode 1204b), and a separate ECG sensing electrode 1206a (e.g., configured similarly to the ECG sensing electrodes 1206 of FIG. 12). The example electronic architecture 1300 is generally similar to the example electronic architecture shown in FIG. 12 and described above, except that in FIG. 13, the second separate ECG sensing electrode 1206b has been combined into the signal processing node 1302. As such, the signal processing node 1302 may include at least one ECG sensing electrode surface configured to sense the surface electrical activity of the patient and an ECG sensing circuit 850 configured to receive and process the sensed surface electrical activity of the patient.
[0195] The electronic architectures shown in FIGS. 8-13 and discussed above are examples, and other configurations of the circuitry and other electronic parts and components of a wearable cardiac defibrillator are also contemplated by this disclosure. In implementations, the driven ground electrode may be implemented differently from the examples of FIGS. 8-13. As an illustration, the driven ground electrode may be part of a combined ECG and therapy component. For example, a combined ECG and therapy component similar to the combined ECG and therapy components 1102 shown in FIG. 11 may include a driven ground electrode instead of or in addition to the second ECG sensing circuit 850b and associated ECG sensing electrode surface(s). In another example, a combined ECG and therapy component may include a driven ground electrode implemented using an electrode surface used for therapy deliver}'. As another illustration, atherapy electrode may include the driven ground electrode (e.g., using an electrode surface used for therapy delivery or a separate electrode surface). As another illustration, the driven ground electrode may be a separate component independent from the combined ECG and therapy components and other electrodes of the wearable cardiac defibrillator (e.g., similar to the separate ECG sensing electrodes 1206 of FIG. 12).
[0196] In implementations, a combined ECG and therapy components may include other functionalities from those discussed with reference to FIGS. 8-13. As an illustration, and noted above, a combined ECG and therapy component may include a driven ground electrode. As another illustration, a combined ECG and therapy component may include parts or devices configured to transmit alarms to the patient. In examples, a combined ECG and therapy component may include the tactile alarm mechanism 830, the speaker 814, one or more lights such as one or more LEDs, and / or the like. For instance, a combined ECG and therapy component may include one or more light configured to light up to warn the patient of an impending therapeutic shock or for another reason, such as to warn the patient of improper assembly of the combined ECG and therapy component into a garment of the wearable cardiac defibrillator.
[0197] In implementations, other sensors or devices may be implemented into a combined ECG and therapy component, a separate therapy electrode, a separate ECG sensing electrode, the signal processing node, and / or the cardiac controller. Such other sensors may include, for example, a motion sensor, a respiration sensor, a bioacoustics sensor, a cardiovibration sensor, a bioimpedance sensor, a blood pressure sensor, a temperature sensor, a pressure sensor, a humidity sensor, a P-wave sensor (e.g.. a sensor configured to monitor and isolate P-waves within an ECG waveform), a tissue fluid sensor, an oxygen saturation sensor (e.g., implemented through photoplethysmography, such as through light sources and light sensorsconfigured to transmit light into the patient’s body and receive transmitted and / or reflected light containing information about the patient’s oxygen saturation), and so on.
[0198] As an illustration, a combined ECG and therapy component, a separate therapy electrode, and / or a separate ECG sensing electrode may include a cardiovibrational sensor (e.g., similar to the cardiovibration sensor 274 of FIG. IB, described above) configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart (e.g.. SI. S2. S3, and / or S4 markers). As another illustration, a combined ECG and therapy component, a separate therapy electrode, and / or a separate ECG sensing electrode may include a bioacoustics sensor configured to sense bioacoustics signals of the patient’s heart (e.g., the lub-dub sounds associated with heart valves closing). The bioacoustics sensor may similarly generate bioacoustics signals indicative of bioacoustics markers of the patient’s heart (e.g., SI, S2, S3, and / or S4 markers). In implementations, each combined ECG and therapy component, separate therapy electrode, and / or separate ECG sensing electrode may include a cardiovibrational or bioacoustics sensor. The cardiac controller may only record data from the cardiovibrational or bioacoustics sensor in the best position for detecting cardiovibrational or bioacoustics signals (e.g., the sensor that will generate the best quality signals due to being closest to the patient’s heart). In implementations, a cardiovibrational or bioacoustics sensor may be configured as a separate cardiovibrational or bioacoustics component configured to be removably disconnectable from another component of the wearable cardiac defibrillator. For example, the cardiovibrational or bioacoustics component may be plugged into the housing of the combined ECG and therapy components. The patient or another caregiver can insert the cardiovibrational or bioacoustics component into the combined ECG and therapy component that will provide the best quality cardiovibrational or bioacoustics signals (e.g., the combined ECG and therapy component closest to the patient’s heart). As another example, the cardiovibrational or bioacoustics component may be similarly plugged into the housing separate therapy electrodes and / or separate ECG sensing electrodes. In implementations, a cardiovibrational or bioacoustics sensor may be integrated into another component of the wearable cardiac defibrillator, such as a separate driven ground electrode. Similar implementations may be applied, for example, to a bioimpedance sensor, an RF sensor (e.g.. used to determine pulse oximetry, oxygen saturation, blood pressure, heart rate, etc.), and / or the like.
[0199] FIGS. 14A and 14B illustrate views of an example combined ECG and therapy component 1400 according to various embodiments. For instance, the example combined ECG and therapy component may include the functionalities of the combined ECG and therapycomponent 840 shown in FIG. 8 and described above. More specifically, FIG. 14A shows a top-down perspective of the example combined ECG and therapy component 1400 (e.g.. a top face of the combined ECG and therapy component 1400 configured to face away from the patient while being used by the patient). FIG. 14B show-s a bottom-up perspective of the example combined ECG and therapy component 1400 (e.g., a bottom face of the combined ECG and therapy component 1400 configured to face the patient’s skin while being used by the patient).
[0200] As illustrated in FIGS. 14A and 14B, in implementations, the example combined ECG and therapy component 1400 may include a first electrode surface 1402a and a second electrode surface 1402b (collectively, electrode surfaces 1402) configured to contact the patient’s skin. Using the electrode surfaces 1402. the combined ECG and therapy component 1400 may sense surface electrical activity of the patient and deliver therapeutic shocks to the patient (e.g., from the vector sweeping therapeutic shocks). For example, the first electrode surface 1402a may be a therapy electrode surface configured to deliver therapeutic shocks, and the second electrode surface 1402b may be an ECG sensing electrode surface configured to sense the patient’s surface electrical activity. In implementations, the combined ECG and therapy component 1400 may include additional or fewer electrode surfaces. As an illustration, the combined ECG and therapy component 1400 may include a single electrode surface for sensing electrode surface electrical activity and delivering therapeutic shocks. As another illustration, the combined ECG and therapy component 1400 may include more than two electrode surfaces, such as a therapy electrode surface and two ECG sensing electrode surfaces (e.g., where the combined ECG and therapy component 1400 is implemented similar to the combined ECG and therapy components 1102).
[0201] Stacked on top of the electrode surfaces 1402 is a gel deployment device 1404. The gel deployment device 1404 is configured to store doses of conductive gel, which is configured to increase conductivity between the therapy electrode surface 1402a and the skin surface of the patient, in a series of gel pockets 1406. In implementations, the gel deployment device 1404 is configured similarly to the one or more gel deployment devices 860 discussed above with reference to FIG. 8. In implementations, the gel deployment device 1404 may be permanently affixed to the electrode surfaces 1402. In implementations, the gel deployment device 1404 may be removably attached to the electrode surfaces 1402 (e.g., such that the gel deployment device 1404 may be sw apped out after use to allow for the reuse of the electronic components of the example combined ECG and therapy component 1400).
[0202] As shown, a defibrillation capacitor 1408 and combined ECG and therapy component circuitry 1410 are mounted onto the gel deployment device 1404. The defibrillation capacitor 1408 is configured to store electric energy for one or more therapeutic shocks. In implementations, the defibrillation capacitor 1408 may be configured similarly to the one or more defibrillation capacitors 852 described above with reference to FIG. 8. The combined ECG and therapy component circuitry 1410 may include various circuits or other electrical components configured to control the combined ECG and therapy component 1400. For example, in implementations, the combined ECG and therapy component circuitry 1410 may include an ECG sensing circuit configured to receive and process the surface electrical activity of the patient sensed by the ECG sensing electrode surface 1402b (e.g., configured similarly to the ECG sensing circuit 850 of FIG. 840). As another example, the combined ECG and therapy component circuitry 1410 may include a therapy delivery circuit configured to deliver therapeutic shocks using the energy stored in the defibrillation capacitor 1408 (e.g., configured similarly to the therapy delivery7circuit 856 of FIG. 8). As another example, the combined ECG and therapy component circuitry 1410 may include a gel deployment circuit configured to release the doses of conductive gel from the gel pockets 1406 of the gel deployment device 1404 (e.g., configured similarly to the gel deployment device 860 of FIG. 8). When the gel deployment circuit activates, the gel may be forced out of the gel pockets 1406 and through apertures 1412 on the therapy electrode surface 1402a. The gel may then spread out between the therapy electrode surface 1402a and the skin surface of the patient to increase conductivity in preparation for delivering one or more therapeutic shocks to the patient. As another example, the combined ECG and therapy component circuitry71410 may include a microcontroller (e.g., configured similarly to the microcontroller 854 of FIG. 8).
[0203] In implementations, the combined ECG and therapy component circuitry71410 may include additional circuits to support additional functionalities of the combined ECG and therapy component 1400. For instance, the combined ECG and therapy' component circuitry 1410 may include circuitry7for a driven ground electrode, for an alarm mechanism (e.g., a speaker, a tactile alarm mechanism, etc. implemented on the combined ECG and therapy component 1400), for an additional sensor on the combined ECG and therapy component 1400 (e.g., a motion sensor, a cardiovibrational sensor, a bioacoustics sensor, a respiration sensor, a temperature sensor, etc.), and / or the like. Alternatively, or additionally, the combined ECG and therapy component circuitry 1410 may include a sensor interface (e.g., similar to the sensor interface 254 of FIG. IB) configured to electrically connect to a removable sensor, such as a removable cardiovibrational or bioacoustics component as discussed above.
[0204] FIG. 14C illustrates a bottom-up view of another example combined ECG and therapy component 1450. As shown in FIG. 14C, the example combined ECG and therapy component 1450 may include a first electrode surface 1452a and a second electrode surface 1452b (collectively, electrode surfaces 1452). Similar to the electrode surfaces 1402, the electrode surfaces 1452 may be configured to contact the patient’s skin, with the first electrode surface 1452a being a therapy electrode surface and the second electrode surface 1452b being an ECG sensing electrode surface. Compared to the combined ECG and therapy component 1400, and as shown in FIG. 14C, the combined ECG and therapy component 1450 may have a smaller surface area for the therapy electrode surface 1452a versus the therapy electrode surface 1402a. Additionally, the ECG sensing electrode surface 1452b may be circular, as opposed to the rectangular shape of the ECG sensing electrode surface 1402b. Such electrode configurations may be more comfortable for the patient to wear. In implementations, the combined ECG and therapy component may include a circular therapy electrode surface, which may have a reduced chance of skin bums during therapy delivery.
[0205] In implementations, the combined ECG and therapy component 1450 may include additional parts similar to the combined ECG and therapy component 1400. For example, the back face of the combined ECG and therapy component 1450 may be configured similarly to the back face of the combined ECG and therapy component 1400 shown in FIG. 14A, with a gel deployment device, defibrillation capacitor 1408, and therapy component circuitry 1410. Accordingly, the first, therapy electrode surface 1452a also includes a number of apertures 1454 for the purpose of releasing and dispersing conductive gel betw een the electrode surface 1452a and a skin surface of the patient.
[0206] FIG. 14D illustrates a bottom-up view- of another example combined ECG and therapy component 1460. The example combined ECG and therapy component 1460 may include a first electrode surface 1462a, a second electrode surface 1462b, and a third electrode surface 1462c (collectively, electrode surfaces 1462). As with the electrode surfaces 1402, the electrode surfaces 1462 may be configured to contact the patient’s skin, with the first electrode surface 1462a being a therapy electrode surface and the second and third electrode surfaces 1462b and 1462c being ECG sensing electrode surfaces. Accordingly, as shown and compared to the combined ECG and therapy component 1400 and the combined ECG and therapy component 1450, the combined ECG and therapy component 1460 includes two ECG sensing electrode surfaces. As such, in implementations, an electrode belt including the combined ECG and therapy component 1460 may include additional ECG channels from the additional ECG sensing electrode surfaces. Alternatively, an electrode belt including the combined ECG andtherapy component 1460 may include a combination of separate therapy electrodes and combined ECG and therapy components 1460. For example, the combined ECG and therapy component 1460 may be included in the embodiments shown in FIG. 11 discussed above and in the example electrode belts discussed below with reference to FIGS. 14E-14H.
[0207] In implementations, the combined ECG and therapy component 1460, as with the combined ECG and therapy component 1450. may include additional parts similar to the combined ECG and therapy component 1400. For example, the back face of the combined ECG and therapy component 1460 may include a gel deployment device, defibrillation capacitor 1408, and therapy component circuitry71410. As shown, the first therapy electrode surface 1462a also includes a number of apertures 1464 to release and disperse conductive gel between the electrode surface 1462a and a skin surface of the patient.
[0208] Parts of the combined ECG and therapy components 1400, 1450, and 1460 may be disposed within a separate combined ECG and therapy component housing (not shown) in various implementations. As an example, a combined ECG and therapy component housing may be mechanically coupled to the therapy electrode surface 1402. The gel deployment device 1404, defibrillation capacitor 1408, and combined ECG and therapy component circuitry 1410 may be housed within the combined ECG and therapy component housing. For instance, a housing may snap over the top face of the combined ECG and therapy component 1400 shown in FIG. 14A such that only the electrode surface 1402 is exposed. FIG. 14C illustrates an example of a combined ECG and therapy component housing 1456 coupled to the electrode surfaces 1452 such that the electrode surfaces 1452 can contact the patient’s skin with the other electronic parts protected by the housing 1456. In implementations, the outside surfaces of the parts of the combined ECG and therapy component 1400 may form the combined ECG and therapy component housing.
[0209] In implementations, other therapy components, such as separate therapy electrodes (e.g., therapy electrodes 1104, therapy electrode 1204a, therapy electrode 1204b, etc.), may be configured similarly to the combined ECG and therapy components 1400, 1450, and / or 1460 shown in FIGS. 14A-14D. For instance, a separate therapy electrode may include an electrode surface 1402, a gel deployment device 1404 with gel pockets 1406 configured to store doses of conductive gel that can be dispersed through apertures 1412, and a defibrillation capacitor 1408. The separate electrodes may also include therapy electrode circuitry that is similar to the combined ECG and therapy component circuitry71410 without the ECG sensing functionality7.
[0210] FIGS. 14E-14H illustrate examples of electrode belts, along with simplified electronic architectures. In the example of FIG. 14E, the example electrode belt 1520 includesfour combined ECG and therapy components. A first combined ECG and therapy component 1522 and a second combined ECG and therapy component 1524 each includes two ECG sensing electrode surfaces 1526 and a therapy electrode surface 1528. In implementations, the first and second combined ECG and therapy components 1522 and 1524 may be configured similarly to the combined ECG and therapy component 1460 shown in FIG. 14D. The electrode belt 1520 also includes a third combined ECG and therapy component 1530 and a fourth combined ECG and therapy component 1532, where each of the third and fourth combined ECG and therapy components 1530 and 1532 includes one ECG sensing electrode surface 1526 and a therapy electrode surface 1528. In implementations, the third and the fourth combined ECG and therapy components 1530 and 1532 are configured similarly to the combined ECG and therapy component 1400 shown in FIGS. 14A and 14B and / or the combined ECG and therapy component 1450 shown in FIG. 14C.
[0211] FIG. 14E also includes a simplified electronic architecture for each of the combined ECG and therapy components 1522, 1524, 1530, and 1532. As shown, the electronic architectures 1522a, 1524a, 1530a, and 1532a for the first, second, third, and fourth combined ECG and therapy components 1522, 1524, 1530. and 1532 includes at least an ECG sensing circuit, a therapy delivery circuit, and one or more defibrillation capacitors. In implementations, the ECG sensing circuit may be structured similarly to the ECG sensing circuit 850 described above, configured to receive and process sensed surface electrical activity from the ECG sensing electrode surface 1526 (e.g., for the third and fourth combined ECG and therapy components 1530 and 1532) or surfaces 1526 (e g., for the first and second combined ECG and therapy components 1522 and 1524). In implementations, the first and second combined ECG and therapy components 1522 and 1524 may have a first ECG sensing circuit corresponding to a first of the ECG sensing electrode surfaces 1526 and a second ECG sensing circuit corresponding to a second of the ECG sensing electrode surfaces 1526, for example, similar to ECG sensing circuits 850a and 850b of combined ECG and therapy components 1102a and 1102 shown in FIG. 11. In implementations, the therapy delivery circuit may be structured similarly to the therapy delivery circuit 856 discussed above and be configured to deliver therapeutic shocks to the patient. In implementations, the one or more defibrillation capacitors may be structured similarly to the one or more defibrillation capacitors 852, configured to store electrical energy for therapeutic shocks. In implementations, the combined ECG and therapy components 1522, 1524, 1530, and 1532 may include additional parts, such as parts discussed above with respect to FIGS. 8-13. For example, the first and second combined ECG and therapy components 1522 and 1524 may be configured similarly to thecombined ECG and therapy components 1102 discussed above with reference to FIG. 11. As another example, the third and fourth combined ECG and therapy components 1530 and 1532 may be configured similarly to the combined ECG and therapy components 840 discussed above with reference to FIG. 8.
[0212] As shown in FIG. 14E, the electrode belt 1520 also includes a signal processing node 1534 electrically connected to each of the combined ECG and therapy components 1522, 1524, 1530, and 1532 via cables 1538 and further configured to electrically connect the combined ECG and therapy components 1522 to a cardiac controller 1536 via the cables 1538. In implementations, and as illustrated in FIG. 14E, the electronic architecture 1534a for the signal processing node 1534 may include at least a PCBA, a tactile alarm mechanism, and a driven ground electrode. The PCBA may be structured similarly to the secondary PCBA 824, and the tactile alarm mechanism may be structured similarly to the tactile alarm mechanism 830. In implementations, the driven ground electrode may be structured similarly to the driven ground electrode 828 discussed with reference to FIG. 8. For example, the driven ground electrode circuitry may be implemented at the signal processing node 1534, and the driven ground electrode surface may be implemented in at the signal processing node 1534 or on one of the combined ECG and therapy components 1522. In implementations, the signal processing node 1534 may include additional parts, such as parts discussed above with reference to FIGS. 8-13. For instance, the signal processing node 1534 may be configured similarly to the signal processing node 820 discussed above with respect to FIG. 8 or the signal processing node 920 discussed with respect to FIG. 9.
[0213] The cardiac controller 1536 may include an electronic architecture 1536a that includes as examples a main PCBA, a battery', and a user interface. In implementations, the main PCBA may be structured similarly to the main PCBA 816, and the battery’ may be structured similarly to the battery 802. Additionally, the user interface may include, for instance, a display7(e.g., structured similarly to the display 808), a speaker (e.g., structured similarly to the speaker 814), and / or at least one response button (e.g., structured similarly to the at least one response button 804). In implementations, the cardiac controller 1536 may include additional parts, such as parts discussed above with reference to FIGS. 8-13. As an example, the cardiac controller 1536 may be configured similarly to the cardiac controller 801 discussed with reference to FIG. 8, the cardiac controller 901 discussed with reference to FIG. 9, or the cardiac controller 1001 discussed with reference to FIG. 10.
[0214] FIG. 14F shows another example electrode belt 1540. As shown, the example electrode belt 1540 includes a first combined ECG and therapy component 1542, a secondcombined ECG and therapy component 1544, a third ECG and therapy component 1546, and a fourth ECG and therapy component 1548, which are electrically connected to a signal processing node 1550 via cables 1554. The signal processing node 1550, in turn, is electrically coupled to a cardiac controller 1552 via the cables 1554. In implementations, the example electrode belt 1540 is structured similarly to the electrode belt 1520 shown in FIG. 14E, except that the third and fourth combined ECG and therapy components 1546 and 1548 include two ECG sensing electrode surfaces 1526. As such, the example electronic architectures 1542a. 1544a, 1546a, 1548a, 1550a, and 1552a may be configured similarly to the electronic architectures 1522a, 1524a, 1530a, 1532a, 1534a, and 1536a, respectively, discussed with reference to FIG. 8.
[0215] FIG. 14G illustrates another example of an electrode belt 1560. The example electrode belt 1560 includes a first combined ECG and therapy component 1562 and a second ECG and therapy component 1564. In implementations, the first and second ECG and therapy components 1562 and 1564 are configured similarly to the first and second ECG and therapycomponents 1522 and 1524 discussed above. As such, the example electronic architectures 1562a and 1564a may be configured similarly to the example electronic architectures 1522a and 1524a. However, as shown, the electrode belt 1560 also includes a first separate therapy electrode 1566 and a second separate therapy electrode 1568 and no signal processing node. The separate therapy electrodes 1566 and 1568 do not include ECG circuitry or ECG sensing electrode surfaces, so the ECG channels are generated just from the combined ECG and therapy components 1562 and 1564. Additionally, as shown, the separate therapy electrodes 1566 and 1568 incorporate the parts and functionalities of the signal processing node such that the signal processing node can be eliminated.
[0216] For example, as shown by the electronic architecture 1566a for the first separate therapy electrode 1566, the first separate therapy electrode 1566 may include a therapy delivery circuit and one or more defibrillation capacitors and further be configured to carry out signal processing node functions. In implementations, the therapy delivery- circuit may be structured similarly to the therapy delivery circuit 856, and the one or more defibrillation capacitors may be structured similarly to the one or more defibrillation capacitors 852. In implementations, the first separate therapy electrode 1566 may be configured to, for example, control the charging of the defibrillation capacitors for the first and second combined ECG and therapy components 1562 and 1564, as well as the first and second separate therapy electrodes 1566 and 1568. As such, the first separate therapy electrode 1566 may include SCP and HVP circuits 822, a secondary PCBA, a microcontroller 826, and an HV capacitor charging circuit 832, similar tothe signal processing node 820 discussed above. In implementations, as shown by the example electronic architecture 1568a, the second separate therapy electrode 1568 may similarly include a therapy delivery circuit and one or more defibrillation capacitors. However, the second separate therapy electrode 1568 may also include a tactile alarm mechanism and a driven ground electrode. The tactile alarm mechanism and the driven ground electrode may be implemented similarly as discussed with reference to the signal processing node 1534 and signal processing node electronic architecture 1534a with reference to FIG. 14E above.
[0217] As further illustrated in FIG. 14G, in embodiments, the first combined ECG and therapy component 1562 is electrically connected to the first separate therapy electrode 1566 via cables 1572. The second combined ECG and therapy component 1564 is electrically connected to the second separate therapy electrode 1568 via the cables 1572. The second separate therapy electrode 1568 is electrically connected to the first separate therapy electrode 1566, and the first separate therapy electrode 1566 is electrically connected to the cardiac controller 1570, via the cables. In this way, the combined ECG and therapy components 1562 and 1564 and the separate therapy electrodes 1566 and 1568 are all electrically coupled to the cardiac controller 1570. The cardiac controller 1570 may be configured similarly to, for example, the cardiac controller 1536 discussed above, as shown by the example electronic architecture 1570a for the cardiac controller 1570.
[0218] The routing of the cables 1572 between the combined ECG and therapy components 1562 and 1564 and the separate therapy electrodes 1566 and 1568 and to the cardiac controller 1570 is an example of cable routing. Other ways of connecting these components to each other and a cardiac controller may be used, in various implementations. For example, FIG. 14H shows an example electrode belt 1580 configured similarly to the electrode belt 1560 except with different cable 1582 routing between the components of the electrode belt 1580. In particular, in the electrode belt 1580, the first combined ECG and therapy component 1562, the second combined ECG and therapy component 1564, and the second separate therapy electrode 1568 are all individually electrically connected to the first separate therapy electrode 1566 via cables 1582. The first separate therapy electrode 1566 is then electrically coupled to the cardiac controller 1570 via the cables 1582.
[0219] FIG. 15 illustrates an example circuit diagram 1500 for therapy components implementing vector sweeping therapeutic shocks delivered to a patient 1502. The example circuit diagram 1500 includes circuitry' for a first therapy component 1504a, a second therapy component 1504b. a third therapy component 1504c. and a fourth therapy component 1504d (collectively, therapy component circuitry 1504). For instance, the therapy component circuitry1504 may include combined ECG and therapy components (e.g., combined ECG and therapy components 840 and / or 1102, separate therapy electrodes 1104, 1204a, and / or 1204b). As such, the therapy component circuitry 1504 may represent or include the therapy delivery circuit 856 discussed above.
[0220] The therapy component circuitry' 1504 may include circuitry to charge one or more capacitors in preparation for delivering one or more therapeutic shocks, generate the therapeutic shocks, and deliver the therapeutic shocks to the patient 1502. Accordingly, in implementations, the therapy component circuitry 1504 for each associated therapy component includes a connection 1506 to one or more defibrillation capacitors. For example, the one or more defibrillation capacitors may be configured as the one or more defibrillation capacitors 852 of FIGS. 8-13, the defibrillation capacitor 1408 shown in FIG. 14A, etc. The therapy component circuitry 1504 may also include a connection 1508 to HV capacitor charging circuitry, such as the HV capacitor charging circuitry 832 of FIGS. 8-13. As such, in implementations, the one or more defibrillation capacitors associated with the therapycomponent circuitry 1504 may be configured to be charged via energy received from the HV capacitor charging circuitry connection 1508 and transmitted to the defibrillation capacitor(s) connection 1506. In implementations, when the wearable cardiac defibrillator is preparing to deliver vector sweeping therapeutic shocks to the patient 1502, the HV capacitor charging circuitry may selectively connect to the therapy component circuitry 1504a, 1504b, 1504c, and 1504d via the HV capacitor charging circuitry connections 1508 to ensure that the associated defibrillation capacitors are charged uniformly or mostly uniformly. When the defibrillation capacitors are ready to deliver the therapeutic shocks, the HV capacitor charging circuitry connections 1508 may be disabled (e g., the HV capacitor charging circuitry may be turned off).
[0221] Once the therapy component circuit 1504 is ready to deliver a therapeutic shock to the patient 1502 (e.g., as part of the vector sweeping therapeutic shocks), a gate driver 1510 and a series of switches 1512 may administer a therapeutic shock using the energy stored in the one or more associated defibrillation capacitors. The gate driver 1510 and associated circuitry may be configured to generate voltage for the therapeutic shock. Additionally, in the example circuit diagram 1500, the therapy component circuitry 1504 for each therapy component may include three HV electronically controlled switches 1512. Two of the switches 1512 are top side switches for single fault safety , which connect the one or more defibrillation capacitors to the respective therapy component. The last switch 1512 is a single low side switch. The gate driver 1510 and the switches 1512 also provide the therapeutic shock to anelectrode surface 1514. As an example, the electrode surfaces 1514 may be configured similarly to the electrode surface 1402 shown in FIG. 14B and discussed above. The electrode surface 1514 then delivers the therapeutic shock to the patient 1502.
[0222] In this way, the therapy delivery circuit of each respective combined ECG and therapy component and / or of each respective separate therapy electrode may include a first portion of bridge circuitry, such as an H-bridge, configured to administer the delivery’ of the successive therapeutic shocks (e.g., the gate driver 1510 and switches 1512). The second portion of the bridge circuitry is located in another component of the wearable cardiac defibrillator electrically connected to the respective combined ECG and therapy component or respective separate therapy electrode. For example, in implementations, the HV capacitor charging circuitry may be located in a cardiac controller and / or a signal processing node of the wearable cardiac defibrillator (e.g., as shown in FIGS. 8-13). In implementations, the portion of bridge circuitry located within the therapy component may be the same regardless of whether the therapy component is a combined ECG and therapy component or a separate therapyelectrode. In implementations, the portion of bridge circuitry located within the therapy component may be different depending on whether the therapy component is a combined ECG and therapy component or a separate therapy electrode.
[0223] In implementations, the therapy component circuitry' 1504 may further include circuitry configured to isolate each respective therapy component (e.g., combined ECG and therapy component or separate therapy electrode) during the delivery of the successive therapeutic shocks of the vector sweep therapy when the respective therapy component is not delivering a therapeutic shock. As an illustration, the therapy component circuitry' 1504 may include a shunt circuit configured to isolate the respective therapy component, for example, including a switchable diode. As another illustration, the therapy component circuitry 1504 may include a high-voltage electronically controlled switching device configured to isolate the respective therapy component. For example, the high-voltage electronically controlled switching device may include an insulated-gate bipolar transistor (IGBT).
[0224] In implementations, a wearable cardiac defibrillator configured to provide vector sweeping therapeutic shocks to a patient may also be configured to provide other types of therapy to the patient, such as pacing therapy. As an illustration, at least some of the therapy components (e.g., the combined ECG and therapy components and / or separate therapy electrodes) may be configured to also generate and deliver pacing pulses to the patient. Accordingly, the circuitry configured to generate and deliver the vector sweeping therapeutic shocks (e.g., the HV capacitor charging circuitry' 832, the one or more defibrillation capacitors852, the therapy delivery circuit 856, the therapy component circuitry 1504) may also be configured for pacing. For example, a given therapy component may deliver a pacing pulse to the patient using stored energy in one or more defibrillation capacitors associated with the therapy component (e.g., defibrillation capacitor 1408) and via at least one electrode surface of the respective therapy component (e.g., electrode surface 1402). In implementations, the wearable cardiac defibrillator may deliver pacing pulses to the patient's heart using a similar process as delivering the vector sweeping therapeutic shocks, except at a lower energy level. For example, the wearable cardiac defibrillator may deliver pacing pulses in a predetermined rotational series of therapy vectors traversing the torso of the patient. The predetermined rotational series of therapy vectors used to deliver defibrillation shocks may be the same as or different from the therapy vectors used to deliver pacing pulses. For example, wearable cardiac defibrillator may use a first predetermined rotational series of therapy vectors for defibrillation shocks and a second predetermined rotational series of therapy vectors for pacing shocks.
[0225] In implementations, the wearable cardiac defibrillator may be configured to deliver the pacing pulses synchronously with the patient’s cardiac cycle. As such, the cardiac controller may be configured to determine the patient’s cardiac cycle using current or recent ECG cycles of the patient (e g., based on the last 5 cardiac cycles, based on the last 10 cardiac cycles, based on the last 20 cardiac cycles, etc. of the patient). The cardiac controller may then control the delivery of the pacing pulses to occur at a certain point in the patient’s cardiac rhy thm. For example, the cardiac controller may use a certain number of previous cardiac cycles (e.g., 5, 10, 15, 20, etc.) to determine an average cardiac cycle length, such as an average R-R interval. The cardiac controller may then control the delivery of the pacing pulses to pace the patient, for example, according to a certain portion of the patient’s cardiac cycle based on the previous cycles and average cardiac cycle length. For instance, the cardiac controller may pace the patient according to when the cardiac controller predicts the patient’s next Q wave will occur. In implementations, the wearable cardiac defibrillator may use a feedback loop in delivering pacing pulses to the patient. For example, the wearable cardiac defibrillator may use ECG signals and / or cardiovibrational signals to update subsequent shock timings, energy levels, etc. based on whether previous pacing pulses succeeded or failed. As another example, the wearable cardiac defibrillator may use impedance measurements to adjust energy levels of future pacing pulses to maintain a predetermined current level during pacing.
[0226] Implementing pacing using therapy vectors as described above may have several advantages over other systems for external pacing. When pacing a patient’s heart, it may be difficult to determine capture, or whether the shock succeeds or fails at inducing a heartbeat.With pacing using a rotational series of therapy vectors, the wearable cardiac defibrillator may be able to deliver lower energy pulses compared to other external pacing systems. In addition to such lower energy pulses being more tolerable for a patient, lower energy pulses may make it easier for the wearable cardiac defibrillator to determine capture. For example, the electrode components sensing the patient’s surface electrical activity may be less likely to saturate, making it easier for the wearable cardiac defibrillator to determine whether the pacing pulse succeeded at inducing a heartbeat. Similar considerations may apply to a cardiovibrational sensor (e.g., because the lower energy pulse may mean that the patient moves less during a pacing pulse). In examples, the sensing electrode components may be sequentially isolated during pacing pulses in time with the therapy vectors to prevent saturation of the sensing electrode components closest to the therapy electrode components while allowing other sensing electrode components to continue to sense surface electrical activity.
[0227] In implementations, the wearable cardiac defibrillators configured to deliver vector sweeping therapeutic shocks to a patient may alternatively or additionally be configured to provide multiple sequential therapeutic shocks to a patient. For example, using a wearable cardiac defibrillator described herein, a defibrillation shock may be delivered through multiple vectors formed from pairs of therapy components (e g., combined ECG and therapy components and / or separate therapy electrodes). For example, a wearable cardiac defibrillator may include first and second therapy components positioned on front torso locations of the patient (e.g., an anterior side of the patient) and third and fourth therapy components positioned on back torso locations of the patient (e.g., a posterior side of the patient). The wearable cardiac defibrillator may deliver a first therapeutic shock via the first and third therapy components and a second pulse via the second and fourth therapy components. As another example, a wearable cardiac defibrillator may include a first therapy component positioned on the front of the patient and second and third therapy components positioned on the back of the patient. The wearable cardiac defibrillator may deliver a first therapeutic shock via the first and second therapy components and a second therapeutic shock via the first and third therapy components.
[0228] Additionally, in such wearable cardiac defibrillators, a defibrillation shock may be configured as one or more multiphasic therapeutic pulses, such as one or more biphasic therapeutic pulses. In a biphasic therapeutic pulse, the wearable cardiac defibrillator may deliver a first portion of the therapeutic pulse with a positive polarity (e.g., a positive current from the perspective of a first therapy component to a second therapy component) and a second portion of the therapeutic pulse with a negative polarity (e.g., a negative current from the perspective of the first therapy electrode to the second therapy electrode). As mentioned above,the two portions of the biphasic therapeutic pulse may be separated by a gap of predetermined length (e.g., a gap of around 0.01 ms to around 1 ms), such as an automatically-configured or user-configured length. The first portion and the second portion of the pulse may have the same or different shapes. These shapes may include a square or rectangular waveform, a saw tooth waveform, a truncated exponential w aveform, and / or so on.
[0229] In examples, the defibrillation shock may be configured as one or more quadriphasic therapeutic shocks. In a quadriphasic therapeutic pulse, a first biphasic pulse may be delivered as described above, and further a second biphasic pulse may be delivered following the delivery of the first biphasic pulse. In examples, the portions of the quadriphasic therapeutic pulses may be separated by gaps that are each individually user-configurable or automatically configurable predetermined length (e.g.. a gap of around 0.01 ms to around 100 ms). The first through fourth portions of the pulse may have the same or different shapes. As noted, these shapes may include a square or rectangular waveform, a saw tooth waveform, a truncated exponential waveform, and / or so on.
[0230] In examples, the defibrillation shock may be configured as multiple multiphasic therapeutic shocks that are delivered to the patient. In a multiphasic therapeutic pulse, two or more phases (e.g., with each phase having an opposite polarity from the previous phase) may be delivered to the patient, for example, as described above with reference to biphasic pulses. Two or more of these multiphasic therapeutic pulses may be delivered in succession, where the multiphasic therapeutic pulses are separated by predetermined delays (e.g., a delay of around 0.01 ms to around 100 ms between two multiphasic therapeutic pulses, such as between two biphasic therapeutic pulses). In examples, the predetermined delay may be set to 0 ms such that multiphasic therapeutic pulses may be delivered simultaneously via different vectors.
[0231] In examples, a wearable cardiac defibrillator can be configured to deliver an electrical therapeutic pulse sequence to the patient though a first multiphasic therapeutic pulse (e.g., biphasic therapeutic pulse, triphasic therapeutic pulse, quadriphasic therapeutic pulse) delivered via a first vector formed by a first pair of therapy components and a second multiphasic therapeutic pulse delivered via a second vector formed by a second pair of therapy components. In such implementations, the wearable cardiac defibrillator may include at least one sensing electrode configured to monitor surface electric signals indicative of cardiac activity of the patient and therapeutic components configured to deliver the therapeutic pulses to the patient. In implementations, the w earable cardiac defibrillator may include one or more combined ECG and therapy components configured to perform both of these functions, as described above. The wearable cardiac defibrillator may also include high-voltage circuitryconnecting at least a first pair of the therapy components and a second pair of the therapy components. For example, the electronic architecture shown in FIGS. 8-13 and described above may be applied to deliver multiple sequential defibrillation shocks.
[0232] As an illustration of a treatment sequence, once the wearable cardiac defibrillator has determined that the patient is experiencing a treatable cardiac arrhythmia condition and should be delivered an electrical therapeutic treatment, the wearable cardiac defibrillator proceeds to a first portion of an electrical therapeutic pulse sequence. In implementations, the wearable cardiac defibrillator determines that the patient should be delivered an electrical therapeutic treatment after outputting an alarm (e.g., tactile, visual and / or auditory) for the patient indicating that the wearable cardiac defibrillator suspects that the patient is experiencing a cardiac arrhythmia condition and waiting for the expiry of a predetermined response period during which the patient fails to provide a response to the alert. During the first portion of the electrical therapeutic sequence, the wearable cardiac defibrillator delivers a first multiphasic therapeutic pulse at a first energy level via a first vector formed between therapy components. For example, the wearable cardiac defibrillator may deliver a biphasic therapeutic pulse at a first energy level via a first vector of the therapy components (e.g., deliver the first biphasic therapeutic pulse via a therapy component positioned on the front side of the patient and a therapy component positioned on the back side of the patient). As an illustration, the first biphasic therapeutic pulse may include a truncated exponential waveform in the first phase, followed by a gap. and further followed by a truncated exponential waveform in the second phase.
[0233] During a third portion of the electrical therapeutic pulse sequence, the wearable cardiac defibrillator may deliver a second biphasic therapeutic pulse at a second energy level via a second vector of the therapy components. For example, the wearable cardiac defibrillator may deliver a second biphasic therapeutic pulse at a second energy level via a second vector of the therapy components (e.g., deliver the second biphasic therapeutic pulse via a therapy component positioned on the front side of the patient and a therapy component positioned on the back side of the patient). As an illustration, the second biphasic therapeutic pulse may be configured similarly to the example of the first biphasic therapeutic pulse with a truncated exponential waveform in the first phase, a gap, and a truncated exponential waveform in a second phase. In implementations, however, the second biphasic therapeutic pulse may have a different shape from the first biphasic therapeutic pulse. Additionally, in implementations, the phases of a biphasic therapeutic pulse may include different waveforms rather than the same waveform.
[0234] Between the first portion and the third portion is a second portion of the electrical therapeutic pulse sequence. The second portion of the electrical therapeutic pulse sequence includes implementing a delay between the del i v ery of first biphasic therapeutic pulse and the second biphasic therapeutic pulse. The delay is determined between a leading edge of the first biphasic therapeutic pulse and a leading edge of the second biphasic therapeutic pulse. In implementations, the delay may be greater than or equal to the length of the first biphasic therapeutic pulse such that the wearable cardiac defibrillator delivers the first biphasic therapeutic pulse followed by the second biphasic therapeutic pulse. In implementations, the delay may be less than the length of the first biphasic therapeutic pulse such that the wearable cardiac defibrillator delivers the first biphasic therapeutic pulse and the second biphasic therapeutic pulse partially or completely simultaneously (e.g., there is complete or partial overlap between the first biphasic therapeutic pulse and the second biphasic therapeutic pulse).
[0235] After delivering the therapeutic pulses, the wearable cardiac defibrillator determines whether the cardiac arrhythmia was successfully treated during a fourth portion of the therapydelivery process. If the cardiac arrhythmia successfully treated the patient (i.e., the cardiac rhythm of the patient has returned to a normal sinus rhythm), the wearable cardiac defibrillator may take no further action to treat the patient. However, if the wearable cardiac defibrillator determines that the patient is still experiencing a cardiac arrhythmia, the wearable cardiac defibrillator may perform another electrical therapeutic pulse sequence (e.g., with higher energies being delivered at the first portion and / or the third portion of the sequence). Other examples and further details for the waveforms for the biphasic therapeutic pulses, positions for therapeutic electrodes used to deliver the pulses, pairs of therapeutic components used to deliver the pulses, pulse energy- levels, and delays are discussed in further detail in PCT International App. No. PCT / US2023 / 069260. filed June 28, 2023. titled ’Double Sequential and Multiple Vector Defibrillation for Wearable Cardioverter Defibrillators,’’ which is hereby incorporated by reference in its entirety.
[0236] As discussed above, the wearable cardiac defibrillator 200 shown in FIGS. 1A and IB is an example of a wearable cardiac defibrillator that can be modified or otherwise configured to provide the vector sweeping therapeutic shocks (or multiple sequential therapeutic shocks) described herein. Other embodiments of a wearable cardiac defibrillator may similarly be modified or otherwise configured for vector sweeping (or multiple sequential) therapy. For example, FIG. 16 illustrates another embodiment of a wearable cardiac defibrillator that can be modified as discussed above to provide vector sweeping therapeutic shocks to a patient. More specifically, FIG. 16 shows a hospital wearable defibrillator 1600that is external, ambulatory , and wearable by a patient 1601. In some implementations, hospital wearable defibrillator 1600 can be configured to also provide pacing therapy, e.g., to treat bradycardia, tachycardia, and asystole conditions. The patient 1601 may use the hospital wearable defibrillator 1600 in hospital settings (e.g., for cardiac protection after a cardiac event), or the patient 1601 may use the hospital wearable defibrillator in other settings where the patient 1601 is ambulatory (e.g., at the patient’s home and workplace).
[0237] The hospital wearable defibrillator 1600 can include one or more ECG sensing electrodes 1602a, 1602b, 1602c (e.g., collectively ECG sensing electrodes 1602), therapy electrodes 1604a and 1604b (e.g., collectively therapy electrodes 1604), a cardiac controller 1606, and a signal processing unit 1608. In examples, each of these components can function similarly to the like components of the wearable cardiac defibrillator 200 discussed above with reference to FIGS. 1 A and IB. In implementations, the electrodes 1602 and 1604 can include disposable adhesive electrodes. For example, the electrodes 1602 and 1604 can include sensing and therapy components disposed on separate sensing and therapy electrode adhesive patches. In implementations, both sensing and therapy components can be integrated and disposed on a same electrode adhesive patch that is then attached to the patient 1601.
[0238] As an illustration, the front therapy electrode 1604a attaches to the front of the patient's torso to deliver pacing or defibrillating therapy. Similarly, the back therapy electrode 1604b attaches to the back of the patient's torso. In an example scenario, at least three ECG adhesively attachable sensing electrodes 1602 can be attached at least above the patient’s chest near the right arm (e g., electrode 1602a), above the patient’s chest near the left arm (e.g., electrode 1602b), and towards the bottom of the patient’s chest (e.g., electrode 1602c) in a manner prescribed by a trained professional. In implementations, the hospital wearable defibrillator 1600 may include additional adhesive therapy electrodes 1604. Additionally, or alternatively, the patches shown in FIG. 16 may include additional therapy electrodes 1604 on them, such that at least two vectors may be formed between the therapy electrodes 1604 of the hospital wearable defibrillator 1600.
[0239] In implementations, the cardiac controller 1606 may be configured to function similarly to the cardiac controller 214 of FIG. 1A and cardiac controller 250 of FIG. IB. As shown in FIG. 19, the cardiac controller 1606 may include a user interface 1610 configured to communicate information with the patient 1601. In examples, the patient 1601 being monitored by a hospital wearable defibrillator 1600 may be confined to a hospital bed or room for a significant amount of time (e.g., 75% or more of the patient’s stay in the hospital). As a result, a user interface 1610 can be configured to interact with a user other than the patient 1601 (e.g. ,a technician, a clinician or other caregiver) for device-related functions such as initial device baselining, setting and adjusting patient parameters, and changing the device batteries.
[0240] The hospital wearable defibrillator 1600 may be modified to provide the vector sweeping therapeutic shocks described above. For example, in implementations, the hospital wearable defibrillator 1600 may include adhesive electrodes supporting therapy components similar to the therapy components discussed above (e.g., combined ECG and therapy components and / or separate therapy electrodes as described above, disposed on an adhesive backing). The therapy components may also be configured to be disposed at predetermined, spaced-apart, anatomical positions such that the therapy components are positioned to provide successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the patient's torso.
[0241] FIG. 17 illustrates another example of a wearable cardiac defibrillator that can be modified to provide vector sweeping therapeutic shocks. As shown in FIG. 17, the wearable cardiac defibrillator may be or may include an adhesive assembly 1700. The adhesive assembly 1700 includes a contoured pad 1702 and a housing 1704 configured to form a watertight seal with the contoured pad 1702. In implementations, the housing 1704 is configured to house electronic components of the adhesive assembly 1700, such as electronic components forming a cardiac controller (e.g., similar to the cardiac controller embodiments discussed above). The adhesive assembly 1700 includes a conductive adhesive layer 1706 configured to adhere the adhesive assembly 1700 to a skin surface 1708 of a patient. The adhesive layer 1706 may include, for example, a w ater- apor permeable conductive adhesive material, such as a material selected from the group consisting of an electro-spun polyurethane adhesive, a polymerized microemulsion pressure sensitive adhesive, an organic conductive polymer, an organic semi- conductive conductive polymer, an organic conductive compound, and a semi-organic conductive compound, and combinations thereof.
[0242] The adhesive assembly 1700 also includes at least one therapy electrode 1710 integrated with the contoured pad 1702. In implementations, the adhesive assembly 1700 may include a therapy electrode 1710 that forms a vector with another therapy electrode disposed on another adhesive assembly 1700 adhered to the patient’s body and / or with a separate therapy electrode adhered to the patient’s body. The adhesive assembly 1700 may also include one or more ECG sensing electrodes 1712 integrated with the contoured pad 1702 (e.g., ECG sensing electrodes 1712a and 1712b). In implementations, the adhesive assembly 1700 may alternatively or additionally be in electronic communication with a separate ECG sensing electrode, such as an adhesive sensing electrode adhered to the patient’s body. In examples, asshown in FIG. 17, the therapy electrode(s) 1710 and ECG sensing electrode(s) 1712 may be formed within the contoured pad 1702 such that a skin-contacting surface of each component is coplanar with or protrudes from the patient-contacting face of the contoured pad 1702. Examples of a wearable cardiac device including an adhesive assembly 1700 are described in U.S. Patent Application No. 16 / 585,344, entitled “Adhesively Coupled Wearable Medical Device,” filed on September 27, 2019, which is hereby incorporated by reference in its entirety.
[0243] Similar to the hospital wearable defibrillator 1600 of FIG. 16. the adhesive assembly 1700 may be modified to provide the vector sweeping therapeutic shocks described above. In implementations, the adhesive assembly 1700 may include therapy components similar to the therapy components discussed above. For example, combined ECG and therapy components and / or separate therapy components as described above may be integrated with the contoured pad 1702. As another example, combined ECG and therapy components and / or separate therapy components may be in communication with the electronic components within the housing 1704 and disposed on one or more separate contoured pads configured to be adhesively- attached to the patient. The therapy components may also be configured to be disposed at predetermined, spaced-apart, anatomical positions such that the therapy components are positioned to provide successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the patent’s torso.
[0244] FIG. 18 illustrates another example of a wearable cardiac defibrillator. As shown in FIG. 18, a wearable cardiac defibrillator may include a belted wearable defibrillator 1800 that is external, ambulatory, and wearable by a patient 1801. In implementations, the belted wearable defibrillator 1800 may include a cardiac controller 1802 configured to be worn mounted on a belt 1804 around the patient’s torso. In such examples, the belted wearable defibrillator 1800 may be configured similarly to the hospital wearable defibrillator 1600 shown in FIG. 16. In implementations, the belted wearable defibrillator 1800 may instead include a cardiac controller 1802 integrated into the belt 1804. In such implementations, the belt 1804 includes a number of modules housing the circuitry of the cardiac controller 1802 such that the patient 1801 does not need to wear a separate cardiac controller 1802. Regardless of the implementation, the cardiac controller 1802 implemented either as a separate unit or integrated into the belt 1804 may be configured to function similarly to the medical device controller embodiments described above.
[0245] Similar to the hospital wearable defibrillator 1600, the belted wearable defibrillator 1800 can include adhesive electrodes 1806a, 1806b, 1806c (e.g., collectively adhesive electrodes 1806) configured to be attached to the patient’s skin. For example, the adhesiveelectrodes 1806 may be disposable adhesive electrodes in a wired connection 1808 with the cardiac controller 1802 (or, in implementations, with the belt 1804 including the circui try of the cardiac controller 1802). Alternatively, at least some of the adhesive electrodes 1806 may be wirelessly connected to the cardiac controller 1802 (or, in implementations, with the belt 1804 including the circuitry7of the cardiac controller 1802). For instance, the adhesive electrodes 1806 may be configured to communicate via Bluetooth® with the cardiac controller 1802 (or the belt 1804). In implementations, at least some of the adhesive electrodes 1806 may include both sensing and therapy components integrated into the same electrode adhesive patch that is attached to the patient. In implementations, at least some of the adhesive electrodes 1806 may be a dedicated sensing electrode or a dedicated therapy electrode. For example, adhesive electrodes 1806a and 1806c may be dedicated therapy electrodes. In implementations, the belted wearable defibrillator 1800 may include additional adhesive electrodes 1806 include sensing and / or therapy components configured to form additional sensing and / or therapy electrode vectors.
[0246] Similar to the hospital wearable defibrillator 1600 of FIG. 16 and the adhesive assembly 1700 of FIG. 17. the belted wearable defibrillator 1800 may be modified to provide the vector sweeping therapeutic shocks described above. As an example, in implementations, the belted wearable defibrillator 1800 may include adhesive electrodes supporting therapy components similar to the therapy components discussed above (e.g., combined ECG and therapy components and / or separate therapy electrodes as described above, disposed on an adhesive backing). The therapy components may also be configured to be disposed at predetermined, spaced-apart, anatomical positions such that the therapy components are positioned to provide successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing the patient’s torso.
[0247] Although the subject matter contained herein has been described in detail for the purpose of illustration, such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments, but, on the contrary7, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
[0248] Other examples are within the scope and spirit of the description and claims. Additionally, certain functions described above can be implemented using software, hardware, firmware, hardwiring, or combinations of any of these. Features implementing functions canalso be physically located at various positions, including being distributed such that portions of functions are implemented at different physical locations.
[0249] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. Those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be an example and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the inventive teachings is / are used.
[0250] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
Claims
CLAIMSWhat is claimed is:
1. A wearable cardiac defibrillator configured to provide an ambulatory patient with vector sweeping therapeutic shocks, the wearable cardiac defibrillator comprising: a plurality of combined electrocardiogram (ECG) and therapy components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient such that the plurality of combined ECG and therapy components are positioned to provide a plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing a torso of the patient, wherein each combined ECG and therapy component comprises one or more electrode surfaces configured to sense surface electrical activity of the patient and deliver one or more of the plurality of successive therapeutic shocks, a combined ECG and therapy component housing mechanically coupled to the one or more electrode surfaces, an ECG sensing circuit disposed within the combined ECG and therapy component housing and configured to receive and process the sensed surface electrical activity of the patient, one or more capacitors disposed within the combined ECG and therapy component housing and configured to store electric energy, and a therapy delivery circuit disposed within the combined ECG and therapy component housing and configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component to the patient using the stored electric energy of the one or more capacitors; and a cardiac controller configured to be operably connected to the plurality of combined ECG and therapy components, wherein the cardiac controller is configured to monitor ECG signals generated from the sensed surface electrical activity of the patient, detect that the patient is experiencing a treatable cardiac arrhythmia, and control deliver}’ of the plurality’ of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the plurality of combined ECG and therapy components.
2. The wearable cardiac defibrillator of claim 1, further comprising a garment configured to be worn about the patient’s torso.
3. The wearable cardiac defibrillator of claim 2, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
4. The wearable cardiac defibrillator of claim 2, wherein the garment is configured to support the cardiac controller.
5. The wearable cardiac defibrillator of claim 2, wherein the garment comprises a belt configured to be worn around the patient’s torso.
6. The wearable cardiac defibrillator of claim 5, wherein the garment further comprises shoulder straps connected to the belt, the shoulder straps configured to be worn over the patient’s shoulders.
7. The w earable cardiac defibrillator of claim 1, wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
8. The wearable cardiac defibrillator of claim 1 , further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
9. The w earable cardiac defibrillator of claim 8, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
10. The wearable cardiac defibrillator of claim 8, wherein the plurality of combined ECG and therapy components are configured to be supported by at least one of the one or more adhesive patches.
11. The wearable cardiac defibrillator of claim 1, wherein each combined ECG and therapy component further comprises one or more gel deployment devices configured to store one or more doses of conductive gel configured to increase conductivity betw een a skin surface of the patient and the respective combined ECG and therapy component before the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the torso of the patient; anda gel deployment circuit configured to release the one or more doses of conductive gel before the delivery of the plurality of successive therapeutic shocks.
12. The wearable cardiac defibrillator of claim 1, further comprising a driven ground electrode.
13. The wearable cardiac defibrillator of claim 12. wherein one of the plurality of combined ECG and therapy components comprises the driven ground electrode.
14. The wearable cardiac defibrillator of claim 12. wherein the driven ground electrode is separate from the plurality of combined ECG and therapy components.
15. The wearable cardiac defibrillator of claim 12. wherein the driven ground electrode is configured to be electrically isolated from the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient.
16. The wearable cardiac defibrillator of claim 15. wherein the driven ground electrode is configured to be electrically isolated through an electrical switch.
17. The wearable cardiac defibrillator of claim 15. wherein the driven ground electrode is configured to be electrically isolated through a shunt circuit.
18. The wearable cardiac defibrillator of claim 15, wherein the driven ground electrode comprises a high resistance configured to electrically isolate the driven ground electrode.
19. The wearable cardiac defibrillator of claim 12, further comprising a garment configured to be worn about the patient's torso.
20. The wearable cardiac defibrillator of claim 19. wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
21. The wearable cardiac defibrillator of claim 19. wherein the garment is configured to support the cardiac controller.
22. The wearable cardiac defibrillator of claim 12. wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart. anatomical locations.
23. The wearable cardiac defibrillator of claim 12, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
24. The wearable cardiac defibrillator of claim 23. wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
25. The wearable cardiac defibrillator of claim 1, further comprising one or more response buttons configured to be pressed by the patient to delay the delivery of the plurality of successive therapeutic shocks.
26. The wearable cardiac defibrillator of claim 25, wherein the cardiac controller comprises the one or more response buttons.
27. The wearable cardiac defibrillator of claim 25, further comprising a user response unit, wherein the user response unit comprises the one or more response buttons.
28. The wearable cardiac defibrillator of claim 27, wherein the user response unit is configured to be operably coupled to the cardiac controller.
29. The wearable cardiac defibrillator of claim 27, further comprising a signal processing node configured to be operably coupled to the plurality of combined ECG and therapy components, the cardiac controller, and the user response unit.
30. The wearable cardiac defibrillator of claim 25, further comprising a garment configured to be worn about the patient’s torso.
31. The wearable cardiac defibrillator of claim 30, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart. anatomical locations.
32. The wearable cardiac defibrillator of claim 30, wherein the garment is configured to support the cardiac controller.
33. The wearable cardiac defibrillator of claim 25, wherein the plurality' of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
34. The wearable cardiac defibrillator of claim 25, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
35. The wearable cardiac defibrillator of claim 34. wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
36. The wearable cardiac defibrillator of claim 1, further comprising a signal processing node configured to be operably coupled to the plurality of combined ECG and therapy components and the cardiac controller.
37. The wearable cardiac defibrillator of claim 36, wherein the signal processing node comprises a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks.
38. The wearable cardiac defibrillator of claim 36. wherein the signal processing node comprises a driven ground electrode.
39. The wearable cardiac defibrillator of claim 36. wherein the signal processing node comprises high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each combined ECG and therapy component.
40. The wearable cardiac defibrillator of claim 36. wherein the ECG sensing circuit of each combined ECG and therapy component comprises a first ECG sensing circuit; and wherein the signal processing node comprises an ECG sensing electrode surface configured to sense the surface electrical activity7of the patient; and a second ECG sensing circuit configured to receive and process the sensed surface electrical activity of the patient.
41. The wearable cardiac defibrillator of claim 36. further comprising a garment configured to be worn about the patient’s torso.
42. The wearable cardiac defibrillator of claim 41, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart. anatomical locations.
43. The wearable cardiac defibrillator of claim 41, wherein the garment is configured to support the cardiac controller.
44. The wearable cardiac defibrillator of claim 36, wherein the plurality' of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
45. The wearable cardiac defibrillator of claim 36, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
46. The wearable cardiac defibrillator of claim 45. wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
47. The wearable cardiac defibrillator of claim 1, wherein at least one combined ECG and therapy component of the plurality of combined ECG and therapy components further comprises a speaker configured to issue audio alarms to the patient.
48. The wearable cardiac defibrillator of claim 1, wherein at least one combined ECG and therapy component of the plurality of combined ECG and therapy components further comprises a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart.
49. The wearable cardiac defibrillator of claim 48, wherein the cardiovibration sensor is configured to be removably disconnectable from the combined ECG and therapy component housing.
50. The wearable cardiac defibrillator of claim 1, wherein the cardiac controller comprises high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each combined ECG and therapy component.
51. The wearable cardiac defibrillator of claim 1, wherein the therapy delivery circuit of each respective combined ECG and therapy component comprises a first portion of bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks: and wherein the cardiac controller comprises a second portion of the bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks.
52. The w earable cardiac defibrillator of claim 51. w herein the second portion of the bridge circuitry comprises high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each combined ECG and therapy component.
53. The wearable cardiac defibrillator of claim 51, wherein the first portion of the bridge circuitry comprises a gate driver.
54. The wearable cardiac defibrillator of claim 51, further comprising a garment configured to be worn about the patient's torso.
55. The wearable cardiac defibrillator of claim 54. wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
56. The wearable cardiac defibrillator of claim 54, wherein the garment is configured to support the cardiac controller.
57. The wearable cardiac defibrillator of claim 51, wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart. anatomical locations.
58. The wearable cardiac defibrillator of claim 51, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
59. The wearable cardiac defibrillator of claim 58, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
60. The wearable cardiac defibrillator of claim 1, wherein the ECG sensing circuit of at least one of the plurality of combined ECG and therapy components comprises a first ECG sensing circuit; and wherein the at least one of the plurality of combined ECG and therapy components further comprises a second ECG sensing circuit disposed within the combined ECG and therapy component housing and configured to receive and process the sensed surface electrical activity of the patient.
61. The wearable cardiac defibrillator of claim 60, wherein the first ECG sensing circuit corresponds to a first ECG channel and the second ECG sensing circuit corresponds to a second ECG channel.
62. The wearable cardiac defibrillator of claim 60, wherein the one or more electrode surfaces comprise a first ECG sensing electrode surface configured to sense the surface electrical activity' of the patient and a second ECG sensing electrode surface configured to sense the surface electrical activity' of the patient.
63. The wearable cardiac defibrillator of claim 62, wherein the first ECG sensing circuit corresponds to the first ECG sensing electrode surface and the second ECG sensing circuit corresponds to the second ECG sensing electrode surface.
64. The wearable cardiac defibrillator of claim 1, further comprising one or more ECG sensing electrodes configured to sense the surface electrical activity’, wherein the one or more ECG sensing electrodes are separate from the plurality of combined ECG and therapy components.
65. The wearable cardiac defibrillator of claim 64, wherein the predetermined, spacedapart, anatomical locations comprise front torso locations on the patient; and wherein the one or more separate ECG sensing electrodes are configured to be disposed against a back torso location of the patient.
66. The wearable cardiac defibrillator of claim 64, further comprising a garment configured to be worn about the patient’s torso.
67. The wearable cardiac defibrillator of claim 66, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart. anatomical locations.
68. The wearable cardiac defibrillator of claim 66. wherein the garment is configured to support the cardiac controller.
69. The wearable cardiac defibrillator of claim 64, wherein the plurality' of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart. anatomical locations.
70. The wearable cardiac defibrillator of claim 64, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
71. The wearable cardiac defibrillator of claim 70, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
72. The wearable cardiac defibrillator of claim 1, further comprising one or more therapy electrodes, each therapy electrode configured to deliver one or more of the plurality of successive therapeutic shocks, wherein the one or more therapy electrodes are separate from the plurality of combined ECG and therapy components.
73. The wearable cardiac defibrillator of claim 72, wherein the predetermined, spaced- apart, anatomical locations comprise first predetermined, spaced-apart anatomical locations; andwherein the one or more separate therapy electrodes are configured to be disposed at one or more second predetermined, spaced-apart, anatomical locations such that the plurality of combined ECG and therapy components along with the one or more therapy electrodes are positioned to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the torso of the patient.
74. The wearable cardiac defibrillator of claim 73, wherein the first predetermined, spaced-apart. anatomical locations comprise front torso locations on the patient; and wherein the one or more second predetermined, spaced-apart, anatomical locations comprise one or more back torso locations on the patient.
75. The wearable cardiac defibrillator of claim 72, wherein a therapy electrode of the one or more therapy electrodes comprises a driven ground electrode.
76. The wearable cardiac defibrillator of claim 72, wherein a therapy electrode of the one or more therapy electrodes comprises a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks.
77. The wearable cardiac defibrillator of claim 72, wherein at least one therapy electrode of the one or more therapy electrodes comprises a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart.
78. The wearable cardiac defibrillator of claim 72, wherein the one or more electrode surfaces of each combined ECG and therapy component comprises one or more first electrode surfaces and the one or more capacitors disposed within the combined ECG and therapy component housing comprise one or more first capacitors; and wherein each therapy electrode of the one or more therapy electrodes comprises one or more second electrode surfaces configured to deliver the one or more of the plurality' of successive therapeutic shocks associated with the respective combined ECG and therapy component, a therapy electrode housing mechanically coupled to the one or more second electrode surfaces, and one or more second capacitors disposed within the therapy electrode housing and configured to store electric energy.
79. The wearable cardiac defibrillator of claim 78. wherein the therapy delivery' circuit of each respective combined ECG and therapy component comprises a first therapy delivery circuit; and wherein each therapy electrode of the one or more therapy electrodes comprises a second therapy delivery' circuit disposed within the therapy electrode housing and configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective therapy electrode using the stored electric energy from the one or more second capacitors to the patient.
80. The wearable cardiac defibrillator of claim 79. wherein the second therapy delivery' circuit of each respective therapy electrode comprises a third portion of bridge circuitry' configured to administer the delivery’ of the plurality’ of successive therapeutic shocks; and wherein the cardiac controller comprises a second portion of the bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks.
81. The wearable cardiac defibrillator of claim 78. wherein a therapy electrode of the one or more therapy electrodes comprises high-voltage capacitor charging circuitry configured to charge the one or more first capacitors of each combined ECG and therapy component and the one or more second capacitors of each therapy electrode.
82. The wearable cardiac defibrillator of claim 81, wherein the one or more therapy electrodes comprise a first therapy electrode comprising the high-voltage capacitor charging circuity; and a second therapy electrode comprising at least one of a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery' of the plurality' of successive therapeutic shocks or a driven ground electrode.
83. The wearable cardiac defibrillator of claim 72, further comprising a garment configured to be worn about the patient's torso.
84. The wearable cardiac defibrillator of claim 83, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
85. The wearable cardiac defibrillator of claim 83, wherein the garment is configured to support the cardiac controller.
86. The wearable cardiac defibrillator of claim 72. wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
87. The wearable cardiac defibrillator of claim 72, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
88. The wearable cardiac defibrillator of claim 87, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
89. The wearable cardiac defibrillator of claim 1, wherein each combined ECG and therapy component further comprises a shunt circuit configured to isolate the respective combined ECG and therapy component during the delivery of the plurality of successive therapeutic shocks when the respective combined ECG and therapy component is not delivering the one or more of the plurality of successive therapeutic shocks.
90. The wearable cardiac defibrillator of claim 89, wherein the shunt circuit comprises a switchable diode.
91. The wearable cardiac defibrillator of claim 1, wherein each combined ECG and therapy component further comprises a high-voltage electronically controlled switching device configured to isolate the respective combined ECG and therapy component during the delivery of the plurality of successive therapeutic shocks when the respective combined ECG and therapy component is not delivering the one or more of the plurality of successive therapeutic shocks.
92. The wearable cardiac defibrillator of claim 91, wherein the high-voltage electronically controlled switching device comprises an insulated-gate bipolar transistor (IGBT).
93. The wearable cardiac defibrillator of claim 91, further comprising a garment configured to be worn about the patient’s torso.
94. The wearable cardiac defibrillator of claim 93, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
95. The wearable cardiac defibrillator of claim 93, wherein the garment is configured to support the cardiac controller.
96. The wearable cardiac defibrillator of claim 91. wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
97. The wearable cardiac defibrillator of claim 91 , further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
98. The wearable cardiac defibrillator of claim 97, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
99. The wearable cardiac defibrillator of claim 1, wherein the predetermined, spaced- apart, anatomical locations comprise at least one front torso location on the patient and at least one back torso location on the patient.
100. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations comprise at least two front torso locations on the patient and at least two back torso locations on the patient.
101. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations comprise the at least one front torso location on the patient and at least three back torso locations on the patient.
102. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations comprise the at least one front torso location on the patient and at least two back torso locations on the patient.
103. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations comprise at least two front torso locations on the patient and the at least one back torso location on the patient.
104. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations comprise at least three front torso locations on the patient and the at least one back torso location on the patient.
105. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations further comprise at least one left side location on the patient and at least one right side location on the patient.
106. The wearable cardiac defibrillator of claim 99, wherein the predetermined, spaced- apart, anatomical locations further comprise at least one left side location on the patient.
107. The wearable cardiac defibrillator of claim 99. wherein the predetermined, spacedapart, anatomical locations further comprise at least one right side location on the patient.
108. The wearable cardiac defibrillator of claim 99, further comprising a garment configured to be worn about the patient’s torso.
109. The wearable cardiac defibrillator of claim 108, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart. anatomical locations.
110. The wearable cardiac defibrillator of claim 108, wherein the garment is configured to support the cardiac controller.
111. The wearable cardiac defibrillator of claim 99, wherein the plurality' of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
112. The wearable cardiac defibrillator of claim 99, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
113. The wearable cardiac defibrillator of claim 112, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
114. The wearable cardiac defibrillator of claim 1, wherein the plurality of successive therapeutic shocks comprises at least one therapeutic shock along a plane bisecting the patient’s heart.
115. The wearable cardiac defibrillator of claim 114, wherein the plurality of successive therapeutic shocks are all along the plane bisecting the patient’s heart.
116. The wearable cardiac defibrillator of claim 114, wherein the plurality of successive therapeutic shocks further comprises another at least one therapeutic shock non-coplanar to the plane bisecting the patient's heart.
117. The wearable cardiac defibrillator of claim 114, wherein the plane bisecting the patient’s heart intersects a transverse plane across the torso of the patient.
118. The wearable cardiac defibrillator of claim 1 , wherein the predetermined rotational sequence of therapy vectors transversing the torso of the patient comprises a plurality of direct vectors.
119. The wearable cardiac defibrillator of claim 118, wherein the plurality of direct vectors comprises a plurality of two-electrode direct vectors; and wherein each two-electrode direct vector is formed using a two-electrode set selected from the plurality of combined ECG and therapy components and / or one or more therapy electrodes separate from the combined ECG and therapy components.
120. The wearable cardiac defibrillator of claim 119, wherein the cardiac controller is configured to deliver a therapeutic shock along each two-electrode direct vector by setting a first member from the respective two-electrode set to a first polarity; and setting the other member from the respective two-electrode set to a second polarity from the first member.
121. The wearable cardiac defibrillator of claim 118, wherein the plurality of direct vectors comprises a plurality of four-electrode direct vectors; wherein each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from the combined ECG and therapy components and / or one or more therapy electrodes separate from the combined ECG and therapy components; and wherein members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
122. The wearable cardiac defibrillator of claim 121, wherein the cardiac controller is configured to deliver a therapeutic shock along each four-electrode direct vector by setting a first electrode pair from the respective four-electrode set to a first polarity; and setting the other electrode pair from the respective four-electrode set to a second polarity from the first electrode pair.
123. The wearable cardiac defibrillator of claim 118, further comprising a garment configured to be worn about the patient’s torso.
124. The wearable cardiac defibrillator of claim 123, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
125. The wearable cardiac defibrillator of claim 124, wherein the garment is configured to support the cardiac controller.
126. The wearable cardiac defibrillator of claim 118, wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
127. The wearable cardiac defibrillator of claim 118, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
128. The wearable cardiac defibrillator of claim 127, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
129. The wearable cardiac defibrillator of claim 1, wherein the predetermined rotational sequence of therapy vectors transversing the torso of the patient comprises a plurality of intermediate therapy vectors.
130. The wearable cardiac defibrillator of claim 129, wherein each intermediate therapy vector is formed using an odd group of at least three electrodes selected from the plurality7of combined ECG and therapy components and / or one or more therapy electrodes separate from the plurality of combined ECG and therapy components.
131. The wearable cardiac defibrillator of claim 130, wherein the odd group of at least three electrodes comprises a first set of at least two electrodes, selected from the combined ECG and therapy components and / or the one or more separate therapy electrodes, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
132. The wearable cardiac defibrillator of claim 130, wherein the cardiac controller is configured to deliver a therapeutic shock along each intermediate vector by setting members from a first set of at least two electrodes selected from the respective odd group of at least three electrodes to a first polarity7; and setting the remaining member or members from the respective odd group of at least three electrode set to a second polarity7from the first set.
133. The wearable cardiac defibrillator of claim 129, further comprising a garment configured to be worn about the patient’s torso.
134. The wearable cardiac defibrillator of claim 133, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
135. The wearable cardiac defibrillator of claim 134, wherein the garment is configured to support the cardiac controller.
136. The wearable cardiac defibrillator of claim 129, wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
137. The wearable cardiac defibrillator of claim 129, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
138. The wearable cardiac defibrillator of claim 137, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
139. The wearable cardiac defibrillator of claim 1, wherein at least some of the plurality of combined ECG and therapy components are further configured for pacing the patient’s heart by delivering a plurality of pacing pulses.
140. The wearable cardiac defibrillator of claim 139, wherein the therapy delivery circuit of each respective combined ECG and therapy component configured for pacing the patient’s heart is further configured to deliver one or more of the plurality of pacing pulses to the patient using the stored electric energy of the one or more capacitors and via at least one of the one or more electrode surfaces of the respective combined ECG and therapy component configured for pacing the patient’s heart.
141. The wearable cardiac defibrillator of claim 139, wherein the at least some of the plurality of combined ECG and therapy components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient.
142. The wearable cardiac defibrillator of claim 139, wherein the predetermined rotational sequence of therapy vectors traversing the torso of the patient comprises a first predetermined rotational sequence of therapy vectors; and wherein the at least some of the plurality' of combined ECG and therapy components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
143. The wearable cardiac defibrillator of claim 139, further comprising a garment configured to be worn about the patient’s torso.
144. The wearable cardiac defibrillator of claim 143, wherein the garment is configured to support the plurality of combined ECG and therapy components at the predetermined, spaced-apart, anatomical locations.
145. The wearable cardiac defibrillator of claim 143, wherein the garment is configured to support the cardiac controller.
146. The wearable cardiac defibrillator of claim 139, wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
147. The wearable cardiac defibrillator of claim 139, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.
148. The wearable cardiac defibrillator of claim 147, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
149. A wearable cardiac defibrillator configured to provide an ambulatory patient with vector sweeping therapeutic shocks, the wearable cardiac defibrillator comprising: a plurality' of electrode components configured to be disposed at predetermined, spaced-apart. anatomical locations of the patient, wherein at least some of the plurality of electrode components are configured to receive and process sensed surface electrical activity of the patient, and wherein at least some of the plurality of electrode components are configured to provide a plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors trans versing a torso of the patient; and a cardiac controller configured to be operably connected to the plurality of electrode components, wherein the cardiac controller is configured to monitor electrocardiogram (ECG) signals generated from the sensed surface electrical activity of the patient, detect that the patient is experiencing a treatable cardiac arrhythmia, and control a deliver}' of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of thepatient, via the electrode components configured to provide the plurality of successive therapeutic shocks.
150. The wearable cardiac defibrillator of claim 149, wherein the plurality of electrode components comprises a plurality of combined ECG and therapy components.
151. The wearable cardiac defibrillator of claim 150, wherein each combined ECG and therapy component comprises one or more electrode surfaces configured to sense surface electrical activity of the patient and deliver one or more of the plurality of successive therapeutic shocks; a combined ECG and therapy component housing mechanically coupled to the one or more electrode surfaces; an ECG sensing circuit disposed within the combined ECG and therapy component housing and configured to receive and process the sensed surface electrical activity of the patient; one or more capacitors disposed within the combined ECG and therapy component housing and configured to store electric energy; and a therapy delivery circuit disposed within the combined ECG and therapy component housing and configured to deliver the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component to the patient using the stored electric energy' of the one or more capacitors.
152. The w earable cardiac defibrillator of claim 151, wherein each combined ECG and therapy component further comprises one or more gel deployment devices configured to store one or more doses of conductive gel configured to increase conductivity betw een a skin surface of the patient and the respective combined ECG and therapy component before the delivery’ of the plurality’ of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors transversing the torso of the patient; and a gel deployment circuit configured to release the one or more doses of conductive gel before the delivery’ of the plurality’ of successive therapeutic shocks.
153. The w earable cardiac defibrillator of claim 149, further comprising a garment configured to be worn about the patient's torso.
154. The wearable cardiac defibrillator of claim 153, wherein the garment is configured to support the plurality of electrode components at the predetermined, spaced-apart, anatomical locations.
155. The wearable cardiac defibrillator of claim 153, wherein the garment is configured to support the cardiac controller.
156. The wearable cardiac defibrillator of claim 153, wherein the garment comprises a belt configured to be worn around the patient’s torso.
157. The wearable cardiac defibrillator of claim 156, wherein the garment further comprises shoulder straps connected to the belt, the shoulder straps configured to be worn over the patient’s shoulders.
158. The wearable cardiac defibrillator of claim 149, wherein the plurality of electrode components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
159. The wearable cardiac defibrillator of claim 149, further comprising one or more adhesive patches configured to be removably attached to a skin surface of the patient.1 0. The wearable cardiac defibrillator of claim 159, wherein the cardiac controller is configured to be supported by at least one of the one or more adhesive patches.
161. The wearable cardiac defibrillator of claim 159, wherein the plurality7of electrode components are configured to be supported by at least one of the one or more adhesive patches.
162. The wearable cardiac defibrillator of claim 149, further comprising a driven ground electrode.
163. The wearable cardiac defibrillator of claim 162, wherein one of the plurality of electrode components comprises the driven ground electrode.
164. The wearable cardiac defibrillator of claim 149, further comprising one or more response buttons configured to be pressed by the patient to delay the delivery of the plurality of successive therapeutic shocks.
165. The wearable cardiac defibrillator of claim 164, wherein the cardiac controller comprises the one or more response buttons.Il l166. The wearable cardiac defibrillator of claim 165, further comprising a user response unit, wherein the user response unit comprises the one or more response buttons.
167. The wearable cardiac defibrillator of claim 166, further comprising a signal processing node configured to be operably coupled to the plurality of electrode components, the cardiac controller, and the user response unit.
168. The wearable cardiac defibrillator of claim 149, further comprising a signal processing node configured to be operably coupled to the plurality of electrode components and the cardiac controller.
169. The wearable cardiac defibrillator of claim 168. wherein the signal processing node comprises a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery of the plurality7of successive therapeutic shocks.
170. The wearable cardiac defibrillator of claim 168, wherein the signal processing node comprises a driven ground electrode.
171. The wearable cardiac defibrillator of claim 168, wherein the signal processing node comprises high-voltage capacitor charging circuitry configured to charge one or more capacitors of each combined ECG and therapy component.
172. The wearable cardiac defibrillator of claim 168, wherein the signal processing node comprises an ECG sensing electrode surface configured to sense the surface electrical activity of the patient; and an ECG sensing circuit configured to receive and process the sensed surface electrical activity of the patient.
173. The wearable cardiac defibrillator of claim 149, wherein at least one electrode component of the plurality of electrode components further comprises a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart.
174. The wearable cardiac defibrillator of claim 149, wherein each electrode component of the at least some of the plurality of electrode components configured to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectorscomprises a therapy delivery circuit comprising a first portion of bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks; and wherein the cardiac controller comprises a second portion of the bridge circuitry configured to administer the delivery of the plurality of successive therapeutic shocks.
175. The wearable cardiac defibrillator of claim 174, wherein the second portion of the bridge circuitry comprises high-voltage capacitor charging circuitry configured to charge one or more capacitors of each combined ECG and therapy component.
176. The wearable cardiac defibrillator of claim 174, wherein the first portion of the bridge circuitry comprises a gate driver.
177. The wearable cardiac defibrillator of claim 149, wherein the at least some of the plurality of electrode components configured to receive and process the sensed surface electrical activity of the patient comprise a plurality of ECG sensing electrodes configured to sense the surface electrical activity.
178. The wearable cardiac defibrillator of claim 149. wherein the at least some of the plurality of electrode components configured to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors comprise a plurality of therapy electrodes.
179. The wearable cardiac defibrillator of claim 178, wherein a therapy electrode of the plurality of therapy electrodes comprises a driven ground electrode.
180. The wearable cardiac defibrillator of claim 178, wherein a therapy electrode of the plurality of therapy electrodes comprises a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery7of the plurality of successive therapeutic shocks.
181. The wearable cardiac defibrillator of claim 178, wherein at least one therapy electrode of the plurality of therapy electrodes comprises a cardiovibration sensor configured to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart.
182. The w earable cardiac defibrillator of claim 178, wherein each therapy electrode of the plurality of therapy electrodes comprisesone or more electrode surfaces configured to deliver one or more of the plurality of successive therapeutic shocks; a therapy electrode housing mechanically coupled to the one or more electrode surfaces; and one or more capacitors disposed within the therapy electrode housing and configured to store electric energy.
183. The wearable cardiac defibrillator of claim 182, wherein a therapy electrode of the one or more therapy electrodes comprises high-voltage capacitor charging circuitry configured to charge the one or more capacitors of each therapy electrode.
184. The wearable cardiac defibrillator of claim 183, wherein the one or more therapy electrodes comprise a first therapy electrode comprising the high-voltage capacitor charging circuity; and a second therapy electrode comprising at least one of a tactile alarm mechanism configured to deliver one or more tactile alarms to the patient before the delivery’ of the plurality’ of successive therapeutic shocks or a driven ground electrode.
185. The wearable cardiac defibrillator of claim 149, wherein each electrode component comprises a shunt circuit configured to isolate the respective electrode component during the delivery of the plurality of successive therapeutic shocks when the respective electrode component is not delivering the one or more of the plurality of successive therapeutic shocks.
186. The wearable cardiac defibrillator of claim 149, wherein each electrode component further comprises a high-voltage electronically controlled switching device configured to isolate the respective electrode component during the delivery of the plurality' of successive therapeutic shocks when the respective electrode component is not delivering the one or more of the plurality’ of successive therapeutic shocks.
187. The wearable cardiac defibrillator of claim 149, wherein the predetermined, spacedapart, anatomical locations comprise at least one front torso location on the patient and at least one back torso location on the patient.
188. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations comprise at least two front torso locations on the patient and at least two back torso locations on the patient.
189. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations comprise the at least one front torso location on the patient and at least three back torso locations on the patient.
190. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations comprise the at least one front torso location on the patient and at least two back torso locations on the patient.
191. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations comprise at least two front torso locations on the patient and the at least one back torso location on the patient.
192. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations comprise at least three front torso locations on the patient and the at least one back torso location on the patient.
193. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations further comprise at least one left side location on the patient and at least one right side location on the patient.
194. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations further comprise at least one left side location on the patient.
195. The wearable cardiac defibrillator of claim 187, wherein the predetermined, spacedapart, anatomical locations further comprise at least one right side location on the patient.
196. The wearable cardiac defibrillator of claim 149, wherein the predetermined rotational sequence of therapy vectors transversing the torso of the patient comprises a plurality of direct vectors.
197. The wearable cardiac defibrillator of claim 196, wherein the plurality of direct vectors comprises a plurality of two-electrode direct vectors; and wherein each two-electrode direct vector is formed using a two-electrode set selected from the plurality of electrode components.
198. The wearable cardiac defibrillator of claim 196, wherein the plurality of direct vectors comprises a plurality of four-electrode direct vectors; wherein each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from the plurality of electrode components; andwherein members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
199. The wearable cardiac defibrillator of claim 149, wherein the predetermined rotational sequence of therapy vectors transversing the torso of the patient comprises a plurality of intermediate therapy vectors.
200. The wearable cardiac defibrillator of claim 199, wherein each intermediate therapy vector is formed using an odd group of at least three electrode components selected from the plurality of electrode components.
201. The wearable cardiac defibrillator of claim 200. wherein the odd group of at least three electrodes comprises a first set of at least two electrode components, selected from the plurality of electrode components, configured to be disposed at adjacent predetermined, spaced-apart. anatomical locations of the ambulatory patient.
202. The wearable cardiac defibrillator of claim 149, wherein at least some of the plurality of electrode components are configured for pacing the patient’s heart by delivering a plurality of pacing pulses.
203. The wearable cardiac defibrillator of claim 202, wherein the at least some of the plurality of electrode components configured for pacing the patient’s heart are further configured to provide the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors.
204. The wearable cardiac defibrillator of claim 202, wherein the at least some of the plurality of electrode components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient.
205. The wearable cardiac defibrillator of claim 202, wherein the predetermined rotational sequence of therapy vectors traversing the torso of the patient comprises a first predetermined rotational sequence of therapy vectors; and wherein the at least some of the plurality of electrode components are further configured for pacing the patient’s heart by delivering the plurality of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
206. A method for providing an ambulatory patient with vector sweeping therapeutic shocks, comprising: monitoring electrocardiogram (ECG) signals generated from sensed surface electrical activity of the patient; detecting that the patient is experiencing a treatable cardiac arrhythmia; and controlling delivery’ of a plurality’ of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing a torso of the patient.
207. The method of claim 206, further comprising delivering one or more alarms to the patient before the delivery of the plurality of successive therapeutic shocks.
208. The method of claim 206, further comprising delaying the delivery of the plurality of successive therapeutic shocks based on the patient pressing one or more response buttons.
209. The method of claim 208, wherein the one or more response buttons are on a user response unit.
210. The method of claim 206, wherein monitoring the ECG signals generated from the sensed surface electrical activity’ of the patient comprises monitoring the ECG signals generated from surface electrical activity’ of the patient sensed by a plurality’ of combined ECG and therapy components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient.
211. The method of claim 21 , wherein controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors comprises controlling the delivery’ of the plurality’ of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the plurality of combined ECG and therapy components.
212. The method of claim 211, further comprising sensing the surface electrical activity of the patient and delivering one or more of the plurality’ of successive therapeutic shocks via one or more electrode surfaces of each combined ECG and therapy component, wherein the one or more electrode surfaces are mechanically coupled to a combined ECG and therapycomponent housing.
213. The method of claim 212, further comprising receiving and processing the sensed surface electrical activity of the patient via an ECG sensing circuit disposed within the combined ECG and therapy component housing.
214. The method of claim 213, further comprising storing electric energy by one or more capacitors disposed within the combined ECG and therapy component housing.
215. The method of claim 214, further comprising delivering the one or more of the plurality of successive therapeutic shocks associated with the respective combined ECG and therapy component to the patient using the stored electric energy of the one or more capacitors via a therapy delivery circuit disposed within the combined ECG and therapycomponent housing.
216. The method of claim 212, further comprising storing one or more doses of conductive gel configured to increase conductivity between a skin surface of the patient and the respective combined ECG and therapy component before the delivery' of the plurality' of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors via one or more gel deployment devices disposed in or mechanically coupled to the combined ECG and therapy component housing.
217. The method of claim 216, further comprising releasing the one or more doses of conductive gel before the delivery' of the plurality' of successive therapeutic shocks by a gel deployment circuit disposed in the combined ECG and therapy component housing.
218. The method of claim 211, wherein the plurality of combined ECG and therapy components are configured to be supported by a garment at the predetermined, spaced-apart. anatomical locations.
219. The method of claim 211, wherein the plurality of combined ECG and therapy components are configured to be adhesively attached to a skin surface of the patient at the predetermined, spaced-apart, anatomical locations.
220. The method of claim 211, wherein the plurality of combined ECG and therapy components are configured to be supported by one or more adhesive patches.
221. The method of claim 211, wherein one of the plurality' of combined ECG and therapy components comprises a driven ground electrode.
222. The method of claim 211, wherein a signal processing node is configured to be operably coupled to the plurality of combined ECG and therapy components.
223. The method of claim 222, further comprising delivering one or more tactile alarms to the patient before the delivery of the plurality of successive therapeutic shocks via a tactile alarm mechanism.
224. The method of claim 223, wherein the signal processing node comprises the tactile alarm mechanism.
225. The method of claim 222, wherein the signal processing node comprises a driven ground electrode.
226. The method of claim 222, further comprising charging one or more capacitors of each combined ECG and therapy component via high-voltage capacitor charging circuitry.
227. The method of claim 226, wherein the signal processing node comprises the high- voltage capacitor charging circuitry.
228. The method of claim 222, further comprising generating cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart using one or more cardiovibration sensors.
229. The method of claim 228, wherein the signal processing node comprises the one or more cardiovibration sensors.
230. The method of claim 228, wherein the plurality of combined ECG and therapy components comprises the one or more cardiovibration sensors.
231. The method of claim 211, wherein the predetermined, spaced-apart, anatomical locations comprise at least one front torso location on the patient and at least one back torso location on the patient.
232. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations comprise at least two front torso locations on the patient and at least two back torso locations on the patient.
233. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations comprise the at least one front torso location on the patient and at least three back torso locations on the patient.
234. The method of claim 231, wherein the predetermined, spaced-apart. anatomical locations comprise the at least one front torso location on the patient and at least two back torso locations on the patient.
235. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations comprise at least two front torso locations on the patient and the at least one back torso location on the patient.
236. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations comprise at least three front torso locations on the patient and the at least one back torso location on the patient.
237. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations further comprise at least one left side location on the patient and at least one right side location on the patient.
238. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations further compnse at least one left side location on the patient.
239. The method of claim 231, wherein the predetermined, spaced-apart, anatomical locations further comprise at least one right side location on the patient.
240. The method of claim 206, wherein controlling the delivery of the plurality' of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors comprises controlling the delivery of the plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors comprising a plurality of direct vectors.
241. The method of claim 240, wherein the plurality of direct vectors comprises a plurality of two-electrode direct vectors; and wherein each two-electrode direct vector is formed using a two-electrode set selected from a plurality of electrode components.
242. The method of claim 240, wherein the plurality of direct vectors comprises a plurality of four-electrode direct vectors; wherein each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from a plurality of electrode components: and wherein members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
243. The method of claim 206, wherein the predetermined rotational sequence of therapy vectors trans versing the torso of the patient comprises a plurality of intermediate therapy vectors.
244. The method of claim 243, wherein each intermediate therapy vector is formed using an odd group of at least three electrode components selected from a plurality of electrode components.
245. The method of claim 244, wherein the odd group of at least three electrodes comprises a first set of at least two electrode components, selected from the plurality of electrode components, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
246. The method of claim 206, further comprising pacing the patient’s heart by delivering a plurality of pacing pulses.
247. The method of claim 246, wherein pacing the patient's heart comprises pacing the patient’s heart by delivering the plurality of pacing pulses via a plurality of combined ECG and therapy components.
248. The method of claim 247, wherein controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors comprises controlling the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient via the plurality of combined ECG and therapy components; and wherein at least some of the plurality of combined ECG and therapy components are configured for pacing the patient’s heart and for providing the plurality of successive therapeutic shocks.
249. The method of claim 246, wherein pacing the patient’s heart comprises pacing the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient.
250. The method of claim 246, wherein the predetermined rotational sequence of therapy vectors traversing the torso of the patient comprises a first predetermined rotational sequence of therapy vectors; andwherein pacing the patient’s heart comprises pacing the patient's heart by delivering the plurality of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
251. A non-transitory computer-readable medium storing sequences of instructions executable by at least one processor, the sequences of instructions instructing the at least one processor to provide an ambulatory' patient with vector sweeping therapeutic shocks, the sequences of instructions comprising instructions to: monitor electrocardiogram (ECG) signals generated from sensed surface electrical activity7of the patient; detect that the patient is experiencing a treatable cardiac arrhythmia; and control delivery7of a plurality7of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors traversing a torso of the patient.
252. The non-transitory computer-readable medium of claim 251, wherein the sequences of instructions further comprise instructions to deliver one or more alarms to the patient before the delivery of the plurality of successive therapeutic shocks.
253. The non-transitory computer-readable medium of claim 251, wherein the sequences of instructions further comprise instructions to delay the delivery of the plurality of successive therapeutic shocks based on the patient pressing one or more response buttons.
254. The non-transitory computer-readable medium of claim 251, wherein the instructions to monitor the ECG signals generated from the sensed surface electrical activity of the patient comprise instructions to monitor the ECG signals generated from surface electrical activity7of the patient sensed by a plurality of combined ECG and therapy components configured to be disposed at predetermined, spaced-apart, anatomical locations of the patient.
255. The non-transitory computer-readable medium of claim 254, wherein the instructions to control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors comprise instructions to control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors traversing the torso of the patient, via the plurality of combined ECG and therapy components.
256. The non-transitory computer-readable medium of claim 255, wherein the sequences of instructions further comprise instructions to generate cardiovibrational signals indicative of cardiovibrational markers of the patient’s heart.
257. The non-transitory computer-readable medium of claim 255, wherein the predetermined, spaced-apart, anatomical locations comprise at least one front torso location on the patient and at least one back torso location on the patient.
258. The non-transitory computer-readable medium of claim 251, wherein the sequences of instructions to control the delivery of the plurality of successive therapeutic shocks in the predetermined rotational sequence of therapy vectors comprises instructions to control the delivery of the plurality of successive therapeutic shocks in a predetermined rotational sequence of therapy vectors comprising a plurality of direct vectors.
259. The non-transitory computer-readable medium of claim 258, wherein the plurality of direct vectors comprises a plurality of two-electrode direct vectors; and wherein each two-electrode direct vector is formed using a two-electrode set selected from a plurality of electrode components.
260. The non-transitory computer-readable medium of claim 258, wherein the plurality of direct vectors comprises a plurality of four-electrode direct vectors; wherein each four-electrode direct vector is formed using a four-electrode set of two electrode pairs selected from a plurality of electrode components; and wherein members of each electrode pair are configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory patient.
261. The non-transitory computer-readable medium of claim 251, wherein the predetermined rotational sequence of therapy vectors transversing the torso of the patient comprises a plurality of intermediate therapy vectors.
262. The non-transitory computer-readable medium of claim 261, wherein each intermediate therapy vector is formed using an odd group of at least three electrode components selected from a plurality of electrode components.
263. The non-transitory computer-readable medium of claim 262, wherein the odd group of at least three electrodes compnses a first set of at least two electrode components, selected from the plurality of electrode components, configured to be disposed at adjacent predetermined, spaced-apart, anatomical locations of the ambulatory7patient.
264. The non-transitory computer-readable medium of claim 251, wherein the sequences of instructions further comprise instructions to pace the patient’s heart by delivering a plurality of pacing pulses.
265. The non-transitory computer-readable medium of claim 264, wherein the instructions to pace the patient’s heart comprise instructions to pace the patient’s heart by delivering the plurality of pacing pulses via a plurality of combined ECG and therapy components.
266. The non-transitory computer-readable medium of claim 264, wherein the instructions to pace the patient’s heart comprise instructions to pace the patient’s heart by delivering the plurality of pacing pulses along the predetermined rotational sequence of therapy vectors traversing the torso of the patient.
267. The non-transitory computer-readable medium of claim 266, wherein the predetermined rotational sequence of therapy vectors traversing the torso of the patient comprises a first predetermined rotational sequence of therapy vectors; and wherein the instructions to pace the patient’s heart comprise instructions to pace the patient’s heart by delivering the plurality of pacing pulses along a second predetermined rotational sequence of therapy vectors traversing the torso of the patient.
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