External defibrillator

Abstract

To provide an automatic external defibrillator that can be continuously and comfortably worn by a patient for an extended period of time.SOLUTION: A wearable external defibrillator 1000 includes an upper patch 1002 including a patient engagement substrate, where the patient engagement substrate includes two ECG sensing electrodes 1004 and defibrillator pad electrodes 1006. The wearable external defibrillator includes a lower patch 1008 including a patient engagement substrate, where the patient engagement substrate includes three ECG sensing electrodes 1010 and defibrillator pad electrodes 1012. The ECG sensing electrodes and the defibrillator pad electrodes are configured for long term wear.SELECTED DRAWING: Figure 8

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application No. 61 / 944,008, filed on February 24, 2014, entitled "External Defibrillator", the entire disclosure of which is incorporated herein by reference.

[0002] This application is related to U.S. Patent No. 8,024,037, filed on July 27, 2007, and U.S. Patent No. 8,364,260, filed on August 5, 2011, the entire contents of each of which are incorporated herein by reference.

[0003] Citation of References All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0004] This disclosure generally relates to external defibrillators. In particular, this disclosure relates to an automated external defibrillator that a patient can wear continuously and comfortably for an extended period of time.

Background Art

[0005] In the United States, more than 800,000 people suffer a heart attack, that is, a myocardial infarction (MI), each year. Patients who have had an MI are at increased risk of developing life - threatening abnormal heart rhythms, that is, arrhythmias. This increased risk is due to various structural and electrical abnormalities in the recently damaged heart. However, in most patients, this increased risk is temporary. Patients who have been treated with various procedures and medications to assist in the healing of the heart typically have their risk of developing life - threatening arrhythmias reduced to pre - MI levels. This risk reduction typically occurs several days to several weeks after the onset of the MI.

[0006] In addition to the situation after MI, there are other situations where the patient's arrhythmia risk temporarily increases, such as after a specific type of heart surgery or when starting treatment with a specific drug having arrhythmogenicity. In the case of a patient known to have a risk of arrhythmia and having an ICD or S-ICD in a predetermined position, if it is necessary to remove the ICD / S-ICD for a short period due to infection or malfunction, the patient is also placed in a vulnerable state. In the case of other patients, for example, those having symptoms called heart failure (new diagnosis or acute exacerbation) or cardiomyopathy, specific medication and / or treatment may lead to improvement in heart function and reduce the patient's likelihood of developing arrhythmia to the extent that a permanent implant device such as an ICD or S-ICD becomes unnecessary. However, during the treatment period, when the heart function is recovering or the patient is receiving treatment, these patients are still in a state where they temporarily have a life-threatening arrhythmia risk.

[0007] In the United States, more than 750,000 patients are at risk of sudden cardiac death (SCD) each year. Based on an event rate of up to 4% in high-risk subgroups of the population, improvements in treatment could potentially save up to 30,000 lives annually in the United States. SCD due to ventricular arrhythmia occurs approximately 3.7 million times worldwide, and the survival rate is less than 1%. Improvements in treatment methods and devices are also needed for the treatment of patients at risk of SCD. The devices and methods disclosed herein can be used for patients with a temporarily high risk of SCD as well as those with a chronically high risk. Clinical conditions in which a patient's transient risk of developing a lethal arrhythmia or SCD is increased include patients after implantation of an ICD or S-ICD (e.g., due to infection or mechanical failure), patients with sleep apnea when it is severe, patients with certain arrhythmia syndromes, pediatric patients with structural heart disease, certain patients with severe valvular heart disease, patients who are pregnant or have recently been pregnant and develop peripartum cardiomyopathy, patients with end-stage renal disease or on dialysis, etc., and are not limited thereto. Further examples of conditions that can cause SCD, increase the likelihood of SCD, or predispose a patient to SCD include after heart surgery, new cardiomyopathy, after a heart attack, new heart failure, worsening heart failure, etc. Figure 1 shows statistics and factors that increase the risk of SCD.

[0008] Various investigations of this patient population have shown that certain drugs, particularly those with anti-arrhythmic properties, are not very effective in reducing this temporarily increased arrhythmia risk. Implantable cardioverter-defibrillators (ICDs) and subcutaneous ICDs (S-ICDs) can continuously monitor a patient's arrhythmia and effectively reset the heart rhythm when an arrhythmia occurs, but because there are significant risks associated with implantation, the overall benefit of these defibrillators is limited during this short period of increased risk. By implanting ICDs and S-ICDs in many patients, the arrhythmia risk of those patients will ultimately return to normal, but at the same time, significant undesirable results in terms of health, economy, and society are brought about. In Figure 2, Example 104 of an S-ICD and Example 106 of an ICD are shown.

[0009] Automated external defibrillators (AEDs) are stored on a wall remote from a patient in a location where people gather, such as an airport, and do not monitor the patient for arrhythmias. They are useful only if the AED is present when a patient needs it, there is someone else present who can use the AED when an arrhythmia occurs, that person can recognize that the patient needs defibrillation, and the sensing and defibrillation electrodes can be applied to the patient. Example 102 of an AED is shown in FIG. 2. Wearable external defibrillators and external defibrillators are described in U.S. Pat. Nos. 5,741,306, 6,065,154, 6,280,461, 6,681,003, and U.S. Patent Application Publication No. 2003 / 0095648. Similar products are currently sold as the Zoll Lifecor LifeVest™ Wearable Cardioverter Defibrillator (WCD). Example 100 of a WCD is shown in FIG. 2. Wearable defibrillators do not require implantation surgery, can monitor the patient for arrhythmias while they are worn, and may be removed when such monitoring (and possibly defibrillation shocks) are no longer needed.

[0010] One of the weaknesses of currently available wearable defibrillators (e.g., LifeVest products) is patient non-compliance. Due to the discomfort caused by the size, shape, and weight of these wearable devices, bulkiness under clothing, or limitations of the device itself, patients are reluctant to wear them. Specifically, such devices cannot be worn during showers or bathing, and while it is not impossible to sleep while wearing them, it is often difficult. Therefore, this device is not useful for providing treatment to patients during sleep or showers. Patients have also complained that the LifeVest is too large and uncomfortable. In addition, many patients are becoming anxious about the large number of alarms and notifications from the LifeVest. This growing anxiety further promotes non-compliance. Because these devices are bulky, some patients do not want to use these wearable devices outside in public, as they draw unwanted attention. Patients will feel that this is uncomfortable and troublesome. This can potentially have an adverse effect on the patients' comfortable lives and may lead to the patients being unable to perform their daily activities. All of these factors promote patient non-compliance and prevent the treatment of treatable arrhythmias. In one study, 60% of LifeVest wearers were not saved due to patient non-compliance (Tanawuttiwat T, et al., PACE Online, December 3, 2013). This device can also be easily removed, and treatment cannot be provided to the patient from the vest if it is not being worn.

[0011] Another weakness is that wearable vests such as the LifeVest may be improperly worn in a way that the vest fails to correctly detect the patient's arrhythmia. Improper wearing of the vest may also prevent the vest from delivering a defibrillation shock to the patient. Also, depending on the design of the vest, there may be an increase in false positives of the arrhythmia measured by the vest. Also, the vest has a complex electrode design. Since the vest is worn and removed many times a day, gel is not applied between the defibrillation electrodes and the patient's skin unless a shock is needed and until a shock is required. The mechanism for releasing the gel may fail or may not operate if the vest is improperly worn.

[0012] Accordingly, what is needed is a device that can constantly monitor a patient's heart rhythm to detect arrhythmias, record and store all detected rhythms for later evaluation if needed, automatically and reliably perform defibrillation of the heart if an arrhythmia is detected, be usable for a short period (from several days to several weeks, and in some cases several months) if there is a temporary risk of arrhythmia, be completely non-invasive and reversible, not cause significant or potential permanent physical impairment even when used, and / or, most importantly, be unobtrusive, waterproof, and require minimal maintenance so as to seamlessly blend into the patient's life, thereby protecting the patient from life-threatening arrhythmias throughout this period and enabling the patient to lead a normal daily life without being hindered in physical or mental comfort. If this device needs to perform defibrillation on the patient during this period, an evaluation can be performed on the patient as needed to determine whether this patient will require a permanent ICD or S-ICD. If nothing happens and the patient does not have a persistent arrhythmia risk factor after this temporary period, this device can be removed and the implantation of a permanent device can be avoided. Thus, if there is an easy-to-use defibrillation device that functions to protect patients during a temporarily elevated arrhythmia risk period, it would also be possible to more efficiently distinguish between patients who would benefit from a more permanent implantable device and those who would not.

[0013] In addition, it is also necessary to treat a temporary period of increased risk of sudden cardiac death in a successful and cost-effective way while providing a good patient experience. There is also a need to improve the treatment for patients who need an ICD but do not currently have one, patients who were not initially considered to need an ICD but have been found to have an increased risk of SCD, and patients who would die from SCD without a wearable defibrillator.

[0014] U.S. Patent Nos. 8,024,037 and 8,364,260 disclose wearable extracorporeal defibrillators. Desirable features for a wearable extracorporeal defibrillator include an adhesive material improved for long-term wear, electrodes improved for long-term wear, improved weight distribution of electrical components, improved size and reduction in size, and improved comfort to enhance patient compliance.

[0015] The iRhythm® Zio® Patch is designed to record heart rhythms for up to 14 days. The Zio Patch is relatively small and lightweight in form factor. This is because it does not need to house electrodes for delivering defibrillation shocks or support the electronics necessary for delivering defibrillation shocks.

[0016] There are many challenges in the development of biocompatible adhesive materials and electrodes for long-term wear. Designing an adhesive material that can be worn for more than 10 days is difficult. Natural skin maceration also occurs over time, typically on the order of about 10 - 30 days, but varies depending on the patient's age. This natural skin cell maceration also presents technical challenges that must be solved by the design of the adhesive material and the electrodes. The adhesive material and electrodes also typically cause skin irritation and redness of the skin with long-term wear. It is also desirable to develop and design improved adhesive materials and electrodes that can be used to attach a wearable defibrillator comfortably to a patient for long-term wear. Also, developing a device that is small enough to allow for weight distribution and adheres to a patient such that the device remains useable during long-term wear is a difficult challenge. Further, it is desirable to develop a device that is small enough to be hidden and draws no attention when used in public or can be easily hidden under normal clothing. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0017] The present invention is for solving the problems of the background art.

[0018] This specification discloses an improved wearable defibrillator that a patient can wear comfortably for 24 consecutive hours. This wearable defibrillator can be worn during showering, sleeping, and normal activities. The adhesive material and electrodes are designed to enable long-term wearing and to deliver an effective amount of energy for defibrillation.

[0019] Generally, in one embodiment, a wearable extracorporeal defibrillator includes one or more sensing electrodes configured to engage a patient's skin to detect a cardiac signal, a defibrillation electrode pad configured to engage the patient's skin, configured to deliver an electrical therapy to the patient, and configured to be continuously in electrical communication with the patient's skin, an adhesive material, one or more sensing electrodes, a defibrillation electrode pad, and a fluid movement element configured to move fluid away from the skin to enable the wearable extracorporeal defibrillator to be continuously worn during exercise or showering activities, a patient engagement substrate including the same, an energy source, a controller configured to detect a cardiac signal by the sensing electrodes and to deliver a therapeutic shock to the patient through the defibrillation pads while the patient engagement substrate is engaged with the patient.

[0020] Generally, in one embodiment, a wearable extracorporeal defibrillator includes one or more sensing electrodes configured to engage a patient's skin to detect cardiac signals, a defibrillation electrode pad configured to engage the patient's skin, configured to deliver an electrical therapy to the patient, and configured to be in continuous electrical communication with the patient's skin, an elastic element that conforms to the patient's skin and that is configured to allow the wearable extracorporeal defibrillator to be continuously worn during movement or shower activities by stretching with the patient's skin, a patient engagement substrate including the elastic element, an energy source, a controller configured to detect cardiac signals with the sensing electrodes and to deliver a therapeutic shock to the patient through the defibrillation pad while the patient engagement substrate is engaged with the patient.

[0021] This embodiment and other embodiments may include one or more of the following features. The wearable extracorporeal defibrillator includes a second patient engagement substrate including a second defibrillation electrode pad, a second adhesive material, and a second plurality of sensing electrodes, wherein the second defibrillation electrode pad is configured to engage the patient's skin and deliver electrical therapy to the patient, the second defibrillation electrode pad may be configured to be continuously in electrical communication with the patient's skin, the second defibrillation electrode may further include the second patient engagement substrate that is in electrical communication with an electrical energy source. The wearable extracorporeal defibrillator may further include a battery and one or more capacitors, wherein the controller is configured to charge the one or more capacitors with the battery and discharge the one or more capacitors through the defibrillation electrode pad, and the second defibrillation electrode pad, wherein the electrical energy source may include the one or more capacitors. The battery, the one or more capacitors, and the controller may be enclosed in a housing connected to the patient engagement substrate. The battery, the one or more capacitors, and the controller may be enclosed in two or more separate housings connected to the patient engagement substrate. The housing may be configured to allow water vapor to pass through the housing from the inner surface of the housing to the outer surface. The inner surface of the housing may be permeable to water vapor, and the water vapor may be about 250 g / m per day 2Based on the surface area of the patient engagement substrate, an average moisture permeability exceeding [value] is capable of passing through from the inner surface to the outer surface. The housing may be breathable. The outer surface of the housing may be hydrophobic. The outer surface of the housing may be water-resistant. The wearable defibrillator may further include a fluid transfer layer in fluid communication with the patient engagement substrate within the housing, and the fluid transfer layer may be configured to enhance the fluid mobility across the entire patient engagement substrate. The fluid transfer layer may have an absorption capacity exceeding about 500%. The fluid transfer element may include an adhesive material and the fluid transfer layer. The fluid transfer layer may be configured to move fluid across the entire major surface area of the fluid transfer layer. The wearable defibrillator may further include an absorbent material within the housing. The transfer element may include the absorbent material. The transfer element may include the housing. The wearable defibrillator may further include one or more waterproof housings surrounding one or more capacitors, a battery, and a controller. The wearable defibrillator may further include a support layer configured to engage and support the controller, one or more capacitors, and the battery. The ratio of the total weight of one or more capacitors, the battery, and the controller to the surface area of the patient engagement substrate may be about 2 g / cm 2 or less. The battery, one or more capacitors, and the controller may be encapsulated in a housing separate from the patient engagement substrate and the second patient engagement substrate. The patient engagement surface may have an average moisture permeability based on the surface area of the patient engagement substrate exceeding about 10 g / m per day 2 or more. The patient engagement surface may have an average moisture permeability based on the surface area of the patient engagement substrate exceeding about 50 g / m per day 2 or more. The patient engagement surface may have an average moisture permeability based on the surface area of the patient engagement substrate exceeding about 100 g / m per day 2 or more. The patient engagement surface may have an average moisture permeability based on the surface area of the patient engagement substrate exceeding about 150 g / m per day 2 or more. The patient engagement surface may have an average moisture permeability based on the surface area of the patient engagement substrate exceeding about 200 g / m per day 2 or more. The patient engagement surface may have an average moisture permeability based on the surface area of the patient engagement substrate exceeding about 250 g / m per day 2may exceed. The elastic element may have an average elastic modulus of from about 0.40 MPa to about 0.9 MPa. The patient-engaging substrate may have an average elastic modulus of from about 0.40 MPa to about 0.9 MPa. The patient-engaging substrate may have an average elastic modulus exceeding about 0.40 MPa. The patient-engaging substrate may have an average elastic modulus less than about 5.0 MPa. The patient-engaging substrate may have an average elastic modulus less than about 2.0 MPa. The one or more capacitors may have a total rated capacitance exceeding about 50 μF. The one or more capacitors may have a total voltage exceeding about 100 V. The wearable defibrillator may further include a flexible bridge connecting the first patient-engaging substrate and the second patient-engaging substrate. The flexible bridge may include a conductor configured to provide electrical communication from the second defibrillation pad electrode and the second plurality of ECG sensing electrodes to one or more of the controller and the one or more capacitors. The adhesive material may include an adhesive border along the outer periphery of the first patient-engaging substrate configured to adhere to the wearable defibrillator and the patient's skin, and the wearable defibrillator may have a tapered cross-sectional shape along the adhesive border from a side of the adhesive border facing toward the center of the wearable defibrillator to an outer edge of the adhesive border. The wearable defibrillator may further include a wireless data communication module within the housing. The wearable defibrillator may further include one or more sensors within the housing. The sensors may include one or more of a GPS sensor, an accelerometer, a microphone, and a gyroscope. The wearable defibrillator has a moisture transfer rate from the first patient-engaging substrate to the outside of the housing based on the surface area of the first patient-engaging substrate of about 250 g / m per day 2 may exceed. The first defibrillation pad electrode may include a hydrogel and a carbon fiber fabric structure. The wearable defibrillator has a moisture transfer rate from the second patient-engaging substrate to the outside of the outer layer based on the surface area of the second patient-engaging substrate of about 250 g / m per day 2 may exceed. The wearable defibrillator may further include a user interface. The patient-engaging substrate has an average moisture permeability of about 500 g / m per day 2may exceed. The fluid transfer element may have an average water vapor transmission rate based on the surface area of the patient-engaging substrate of about 50 g / m per day 2 may exceed. The fluid transfer element may have an average water vapor transmission rate based on the surface area of the patient-engaging substrate of about 250 g / m per day 2 may exceed. The adhesive material within the patient-engaging substrate may include perforated holes. The perforated holes may have a diameter of from about 0.5 mm to about 2 mm. The perforated holes of the adhesive material may have an opening area that is from about 10% to about 25% of the total surface area of the adhesive material. The elastic element may include the adhesive material. The wearable extracorporeal defibrillator may be configured to be continuously worn for extended periods of over about 24 hours, during exercise and shower activities. The wearable extracorporeal defibrillator may be configured to be continuously worn for extended periods of over about 5 days, during exercise and shower activities. The wearable extracorporeal defibrillator may be configured to be continuously worn for extended periods of over about 7 days, during exercise and shower activities. The wearable extracorporeal defibrillator may be configured to be continuously worn for extended periods of over about 10 days, during exercise and shower activities.

[0022] Generally, in one embodiment, a wearable extracorporeal defibrillator includes a patient-engaging substrate including an adhesive material, one or more sensing electrodes, and a defibrillation electrode pad, a fluid communication layer in fluid communication with the patient-engaging substrate, a battery, one or more capacitors, and a controller housed in one or more electronic circuit housings, a support layer connected to the electronic circuit housings and the patient-engaging substrate, and an outer housing connected to a portion of the patient-engaging substrate, wherein the one or more electronic circuit housings are between the outer housing and the patient-engaging substrate, and the outer housing.

[0023] This embodiment and other embodiments may include one or more of the following features. The wearable defibrillator may further include an absorption layer in fluid communication with the fluid communication layer. The patient-engaging substrate may have an average water vapor transmission rate based on the surface area of the patient-engaging substrate of about 250 g / m per day 2It may exceed. This wearable defibrillator may further include a second patient engagement substrate including a second defibrillation electrode pad, a second adhesive material, and a second plurality of sensing electrodes, and a second fluid communication layer in fluid communication with the second patient engagement substrate. The second defibrillation electrode pad is configured to engage the patient's skin and deliver electrical therapy to the patient, and the second defibrillation electrode pad may be configured to be continuously electrically communicative with the patient's skin. The second patient engagement substrate may have an average moisture permeability based on the surface area of the second patient engagement substrate of about 250 g / m per day 2 It may exceed. The outer housing may be breathable. The outer surface of the outer housing may be hydrophobic. The outer surface of the outer housing may be water resistant. The fluid communication layer may have an absorption capacity exceeding about 500%. This wearable defibrillator may further include a waterproof housing surrounding one or more capacitors, a battery, and a controller. The patient engagement substrate may have an average elastic modulus of from about 0.40 MPa to about 0.9 MPa. The patient engagement substrate may have an average elastic modulus exceeding about 0.40 MPa. The one or more capacitors may have a total rated capacitance exceeding about 50 μF. The one or more capacitors may have a total voltage exceeding about 100 V. This wearable defibrillator may further include a wireless data communication module within the housing. This wearable defibrillator may further include one or more sensors within the housing. The sensors may include one or more of a GPS sensor, an accelerometer, a microphone, and a gyroscope. The adhesive material within the patient engagement substrate may include perforated holes. The perforated holes may have a diameter of from about 0.5 mm to about 2 mm. The perforated holes of the adhesive material may have an opening area of from about 10% to about 25% of the total surface area of the adhesive material. The fluid communication layer may have an average moisture permeability based on the surface area of the patient engagement substrate of about 50 g / m per day 2 It may exceed. The fluid communication layer may have an average moisture permeability based on the surface area of the patient engagement substrate of about 250 g / m per day 2 It may exceed.

[0024] Generally, in one embodiment, a wearable extracorporeal defibrillator includes a first patient engagement substrate including an adhesive, one or more sensing electrodes, and a first defibrillation electrode pad, where the one or more sensing electrodes are configured to engage the patient's skin to detect a cardiac signal, and the first defibrillation electrode pad is configured to engage the patient's skin and deliver an electrical therapy to the patient, and the first defibrillation electrode pad is configured to be continuously in electrical communication with the patient's skin; the first patient engagement substrate; a housing that is coupled to the first patient engagement substrate to form an internal space therebetween, and the internal portion includes a battery, one or more capacitors, and a controller, and the first defibrillation electrode pad is in electrical communication with the one or more capacitors; the housing; a second patient engagement substrate including a second defibrillation electrode pad, a second adhesive, and a second plurality of sensing electrodes, where the second defibrillation electrode pad is configured to engage the patient's skin and deliver an electrical therapy to the patient, and the second defibrillation electrode pad is configured to be continuously in electrical communication with the patient's skin, and the second defibrillation electrode is in electrical communication with the one or more capacitors; the second patient engagement substrate; and a fluid movement element configured to move fluid away from the skin to enable the wearable extracorporeal defibrillator to be continuously worn for a period of time exceeding 24 hours. The controller is configured to charge the one or more capacitors with the battery and discharge the one or more capacitors through the first defibrillation electrode pad and the second defibrillation electrode pad.

[0025] This embodiment and other embodiments may include one or more of the following features. The wearable extracorporeal defibrillator may be configured to be continuously worn for a long time exceeding about 5 days, even during exercise and shower activities. The wearable extracorporeal defibrillator may be configured to be continuously worn for a long time exceeding about 7 days, even during exercise and shower activities. The wearable extracorporeal defibrillator may be configured to be continuously worn for a long time exceeding about 10 days, even during exercise and shower activities. The wearable defibrillator may have an average moisture permeability from the first patient-engaging substrate, through the housing connected to the first patient-engaging substrate, based on the surface area of the first patient-engaging substrate, exceeding about 250 g / m 2 per day. The first patient-engaging substrate may have an average moisture permeability exceeding about 500 g / m 2 per day. The first and second patient-engaging substrates may have an average elastic modulus of from about 0.40 MPa to about 0.9 MPa. The patient-engaging substrate may have an average elastic modulus exceeding about 0.40 MPa. The housing may be breathable. The outer surface of the housing may be hydrophobic. The outer surface of the housing may be water-resistant. The housing may further include a fluid transfer layer in fluid communication with the first patient-engaging substrate, and the fluid transfer layer may be configured to enhance the fluidity of water across the entire first patient-engaging substrate. The fluid transfer layer may have an absorption capacity exceeding about 500%. The wearable defibrillator may further include an absorbent material in the housing. The wearable defibrillator may further include one or more waterproof housings surrounding one or more capacitors, a battery, and a controller. The wearable defibrillator may further include a support layer configured to engage and support the controller, one or more capacitors, and the battery. The ratio of the total weight of one or more capacitors, a battery, and a controller to the surface area of the patient-engaging substrate is about 2 g / cm 2It may be less than. One or more capacitors may have a total rated capacitance exceeding about 50 μF. One or more capacitors may have a total voltage exceeding about 100 V. This wearable defibrillator may further include a flexible bridge connecting the first patient engagement substrate and the second patient engagement substrate. The flexible bridge may include a conductor configured to provide electrical communication from the second defibrillation pad electrode and the second plurality of ECG sensing electrodes to one or more of the controller and the one or more capacitors. The adhesive material may include an adhesive border along the outer periphery of the first patient engagement substrate configured to adhere to the wearable defibrillator and the patient's skin. The wearable defibrillator may have a tapered cross-sectional shape along the adhesive border, from the side of the adhesive border facing the center of the wearable defibrillator to the outer edge of the adhesive border. This wearable defibrillator may further include a wireless data communication module within the housing. This wearable defibrillator may further include one or more sensors within the housing. The sensors may include one or more of a GPS sensor, an accelerometer, a microphone, and a gyroscope. The first defibrillation pad electrode may include a hydrogel and a carbon fiber fabric structure. The adhesive material within the patient engagement substrate may include perforated holes. The perforated holes may have a diameter of about 0.5 mm to about 2 mm. The perforated holes of the adhesive material may have an opening area of about 10% to about 25% of the total surface area of the adhesive material.

[0026] Generally, in one embodiment, a patient engagement surface includes one or more sensing electrodes configured to engage the patient's skin to detect a cardiac signal, a defibrillation electrode pad configured to engage the patient's skin, configured to deliver electrical therapy to the patient, and configured to be in continuous electrical communication with the patient's skin, an adhesive material, the one or more sensing electrodes, the defibrillation electrode pad, and a fluid movement element configured to allow the wearable extracorporeal defibrillator to be continuously worn during movement or shower activities by moving fluid away from the skin, and a patient engagement substrate including the same.

[0027] This embodiment and other embodiments may include one or more of the following features. The patient engagement surface may further include an elastic element configured to conform to the patient's skin and stretch with the patient's skin to enable the wearable extracorporeal defibrillator to be continuously worn for extended periods exceeding 7 days, even during exercise and shower activities. The patient engagement surface may be configured to be continuously worn for extended periods exceeding about 24 hours, even during exercise and shower activities. The patient engagement surface may be configured to be continuously worn for extended periods exceeding about 5 days, even during exercise and shower activities. The patient engagement surface may be configured to be continuously worn for extended periods exceeding about 10 days, even during exercise and shower activities. The defibrillation pads may include a carbon fiber fabric structure. The patient engagement surface may further include a second defibrillation electrode pad. The patient engagement surface may further include an electronic circuit module in electrical communication with the defibrillation electrode pad and the second defibrillation electrode pad. The patient engagement substrate may have an average elasticity exceeding about 0.40 MPa. Generally, one embodiment is a kit including the wearable extracorporeal defibrillator and one or more of an adhesive remover, a skin cleanser, a hair removal tool, and instructions for applying the wearable defibrillator.

[0028] Generally, in one embodiment, a method of monitoring and defibrillating a patient's heart includes adhering a first patient engagement substrate including a first plurality of sensing electrodes and a first defibrillation pad to a first skin surface portion of the patient, wherein the first defibrillation pad is in electrical communication with an electrical energy source sufficient to deliver a defibrillation shock, and the first patient engagement substrate portion of the wearable defibrillator includes a fluid moving element configured to move fluid away from the first skin surface portion of the patient to enable the wearable extracorporeal defibrillator to be continuously worn during exercise and shower activities; adhering a second patient engagement substrate including a second plurality of sensing electrodes and a second defibrillation pad to a second skin surface portion of the patient, wherein the second defibrillation pad is in electrical communication with an electrical energy source sufficient to deliver a defibrillation shock; and measuring electrical data corresponding to the patient's heart signal with the first plurality of sensing electrodes and the second plurality of sensing electrodes.

[0029] This embodiment and other embodiments may include one or more of the following features. The fluid moving element may move fluid away from the first skin portion and towards the outside of the housing of the wearable defibrillator. The fluid moving element may move fluid from end to end of the major cross-sectional area of the fluid moving element. The fluid moving element may have an average water permeability to the first skin surface portion of the patient of greater than about 50 g / m per day. 2 The fluid moving element may have an average water permeability to the first skin surface portion of the patient of greater than about 250 g / m per day. 2It may exceed. The fluid movement element may include an adhesive material and a suction material, and the adhesive material may be part of the first patient-engaging substrate and the second patient-engaging substrate. The method may further include analyzing electrical data to determine whether the patient has a treatable arrhythmia. The method may further include detecting one or more of the patient's pulse, respiratory rate, heart sound, and heart rate. The method may further include analyzing the detected one or more of the patient's pulse, respiratory rate, heart sound, and heart rate to confirm a treatable arrhythmia. The method may further include delivering an electric shock after determining that the patient has a treatable arrhythmia. The method may further include measuring the patient's transthoracic impedance between the first defibrillation pad electrode and the second defibrillation pad electrode before delivering the electric shock. The method may further include continuously wearing the wearable defibrillator for a long time exceeding about 24 hours. The method may further include continuously wearing the wearable defibrillator for a long time exceeding about 5 days. The method may further include continuously wearing the wearable defibrillator for a long time exceeding about 7 days.

[0030] Generally, in one embodiment, a method of treating a patient with a wearable defibrillator includes receiving ECG data from a plurality of ECG sensing electrodes that form part of the wearable defibrillator and are configured to be worn for a long period of time and continuously make electrical contact with the patient's skin; analyzing the ECG data to determine whether the patient has a treatable arrhythmia; immediately after determining a treatable arrhythmia, detecting one or more of the patient's pulse, respiratory rate, heart sound, and heart rate; analyzing the detected one or more of the patient's pulse, respiratory rate, heart sound, and heart rate to confirm a treatable arrhythmia; measuring the patient's transthoracic impedance between a first defibrillation pad electrode and a second defibrillation pad electrode, wherein the first defibrillation pad electrode and the second defibrillation pad electrode are configured to be worn for a long period of time and continuously make electrical contact with the patient's skin and form part of the wearable defibrillator; instructing a controller to charge a plurality of capacitors within the wearable defibrillator; and delivering a therapeutic electrical shock to the patient through the first defibrillation electrode pad and the second defibrillation electrode pad.

[0031] This embodiment and other embodiments may include one or more of the following features. The method may further include wirelessly transmitting data corresponding to the patient's location to emergency medical services after determining a treatable arrhythmia. The method may further include wirelessly transmitting data corresponding to the patient's location to the patient's emergency contacts after determining a treatable arrhythmia. The step of measuring transthoracic impedance may include determining whether the first defibrillation pad electrode and the second defibrillation pad electrode are in electrical contact with the patient's skin. The method may further include adjusting a therapeutic electric shock based on the transthoracic impedance. The method may further include generating an audible alarm to warn the patient that a therapeutic electric shock may occur before the step of instructing the controller to charge a plurality of capacitors. The method may further include instructing the controller to charge a plurality of capacitors when the shutdown button of the wearable defibrillator is not pressed.

[0032] Generally, in one embodiment, a method for monitoring and defibrillating a patient's heart comprises engaging a patient engagement substrate including an adhesive, one or more sensing electrodes, a defibrillation electrode pad, and an elastic element with the patient's skin; measuring a heart signal with the one or more sensing electrodes; monitoring the one or more sensing electrodes with a controller configured to charge one or more capacitors with a battery, an electrical energy source, and deliver an electrical therapy to the patient by discharging the electrical energy source through the defibrillation electrode pad; supporting the controller in electrical contact with the one or more sensing electrodes and the defibrillation electrode pad; continuously performing the engaging, measuring, and supporting steps for at least 24 hours. The elastic element may have an average elastic modulus of from about 0.40 MPa to about 0.9 MPa. The engaging, measuring, and supporting steps may be continuously performed for at least about 48 hours. The engaging, measuring, and supporting steps may be continuously performed for at least about 5 days. The engaging, measuring, and supporting steps may be continuously performed for at least about 7 days. The engaging, measuring, and supporting steps may be continuously performed for at least about 10 days. The engaging, measuring, and supporting steps may be continuously performed during exercise or shower activities.

[0033] The novel features of the invention are set forth with particularity in the appended claims. The features and advantages of the invention will be better understood from the following detailed description of exemplary embodiments in which the principles of the invention are utilized and the accompanying drawings.

Brief Description of the Drawings

[0034]

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DETAILED DESCRIPTION OF THE INVENTION

[0035] In this specification, an improved wearable defibrillator will be described. This wearable defibrillator can be worn comfortably by a patient throughout the day, including during showers and sleep. The electrodes and adhesives are designed to be worn for a long time while minimizing discomfort and skin irritation caused by them.

[0036] This wearable defibrillator can only detect and treat arrhythmias when worn. Without this device being worn, life-saving treatment cannot be performed. The effectiveness of this device is maximized by continuous wearing. One goal is to make the device as small, lightweight, comfortable to wear, and unobtrusive as possible in order to increase patient compliance. It is desirable to minimize the size and weight of each component of the device, but on the other hand, each component must also be reliable and robust enough to withstand the forces encountered in showers and other normal human activities. The components of this device that are attached to the patient's skin also need to adapt to sweating and skin elongation under the attachment substrate so as to remain comfortably attached to the skin while maintaining skin health.

[0037] In this specification, several different aspects of this defibrillator are disclosed. This defibrillator typically includes defibrillation electrodes (also called defibrillation pads), ECG monitoring electrodes (also called sensing electrodes), electronic components for determining when a defibrillation shock is needed, a battery, one or more capacitors, and the like.

[0038] One challenge is to design components including the capacitor and battery to be sufficiently lightweight and compact to be attached to the patient's body while being robust and highly reliable. Another challenge is to design the outer shape of the device and each component so that the weight distribution across the patient's body is ergonomic and unobtrusive in a comfortable manner.

[0039] Furthermore, the defibrillator of the present invention includes a patient engagement substrate. Since the present defibrillator is to be attached to the patient's skin for a long period (e.g., 7 - 10 days or more), in addition to supporting the ECG sensing electrodes and defibrillation pads in a sufficient electrical contact state with the skin, it includes an element designed to adapt to sweating from the skin under the defibrillator, and an element designed to stretch and move in accordance with the stretching and movement of the skin under the defibrillator to maintain the health of the skin and good wearing comfort during long-term wear. Therefore, since the electrodes and other defibrillator components do not need to be permeable to moisture or water vapor from the skin, one or more other elements of the substrate may perform its function. Failure to absorb and / or remove sweat may result in adhesion failure and / or skin irritation, which may limit the ability to attach the defibrillator (including sensing electrodes and defibrillation electrodes) to the skin over a long period. Also, if the skin under the patient engagement substrate deteriorates, the patient may have difficulty attaching a new defibrillator engagement structure to the same location on the skin during subsequent monitoring periods. To further increase the water vapor transmission rate of this wearable defibrillator, a breathable outer housing may be used.

[0040] Another challenge is to design a wearable defibrillator that can be worn continuously, including during normal activities such as exercise and showering. The Lifevest™ is not suitable for use during showering and must be removed before showering. Other conventional AEDs cannot be used when the patient is wet (e.g., during showering) and thus cannot protect the patient during showering. The wearable defibrillator disclosed herein is suitable for continuous wear during exercise and shower activities. The wearable defibrillator described herein can also monitor ECG signals and deliver defibrillation shocks to a patient during showering. In some embodiments, the wearable external defibrillator described herein is configured to be worn continuously for extended periods of time exceeding about 24 hours, including during exercise and shower activities. In some embodiments, the wearable external defibrillator described herein is configured to be worn continuously for extended periods of time exceeding about 48 hours, including during exercise and shower activities. In some embodiments, the wearable external defibrillator described herein is configured to be worn continuously for extended periods of time exceeding about 5 days, including during exercise and shower activities. In some embodiments, the wearable external defibrillator described herein is configured to be worn continuously for extended periods of time exceeding about 7 days, including during exercise and shower activities. In some embodiments, the wearable external defibrillator described herein is configured to be worn continuously for extended periods of time exceeding about 10 days, including during exercise and shower activities.

[0041] Another challenge is to design an adhesive material that can securely and comfortably attach the device to the patient's skin while minimizing skin irritation during long-term wear. Many types of adhesive materials cause skin irritation with wear exceeding a few hours. Skin irritation can be bothersome to the patient and, if excessive, can lead to non-compliance where the patient removes the device. The adhesive material of the patient engagement substrate must provide a good fit over a typical wear period, e.g., about 7 - 14 days.

[0042] The impedance of the skin may also change due to natural eschar formation of the skin. The design and contact of the electrodes must also take into account changes in the impedance of the skin. Natural eschar formation of the skin typically occurs when the period exceeds about 10 to 30 days. For some patients, it may be difficult to design an electrode that can maintain the impedance and electrical contact with the skin at an acceptable level over a period exceeding 10 days due to natural eschar formation of the skin. One possible solution to this problem is to change the position of the electrode so that the electrode contacts another location on the skin after a set period has elapsed.

[0043] If the wearing period exceeds 5 days, it may be regarded as long-term wearing. According to some embodiments, the patient engagement substrate is configured such that the period of being worn at one location on the skin is more than about 7 days, more than about 10 days, from about 10 days to about 14 days, from about 14 days to about 21 days, or from about 21 days to about 1 month (approximately 30 days). After a specified period has elapsed since the device was worn, for example, from about 10 days to 14 days, the device may be moved so that the electrodes and the adhesive contact another location on the patient's skin, and then the device can be worn at the second location for 10 to 14 days. This process may be repeated as many times as necessary throughout the wearing time of the defibrillator. The total wearing time of the device may vary depending on the patient to be treated and the symptoms. According to some embodiments, the wearing period of this wearable defibrillator exceeds about 30 days, exceeds about 45 days, exceeds about 60 days, exceeds about 90 days, exceeds about 120 days, exceeds about 150 days, exceeds about 180 days, exceeds about 210 days, exceeds about 240 days, exceeds about 270 days, exceeds about 300 days, exceeds about 330 days, or exceeds about 360 days. For patients with permanent contraindications to implanted devices such as ICDs and S-ICDs, that is, patients for whom an implanted solution is impossible, the wearing period will be lifelong.

[0044] This specification discloses various long-term wear electrode configurations and electrode materials that can be used in the wearable defibrillator described herein. Commercially available electrode pads, such as those from Zoll and 3M, are not suitable for long-term wear. Most of the Zoll and 3M pads are designated for 8 hours of use. In contrast, the design and materials of the patient engagement substrate described herein make it possible to wear the defibrillator for a long time.

[0045] To improve the comfort of the device and enable longer-term wear of the device, various characteristics of the device may be selected. When the body moves, the skin stretches, and when the body returns to its original position, the skin returns to its original position. The characteristics of the portion of the device in contact with the skin may be adjusted to adapt to such elastic characteristics of the skin. Although some components of the patient engagement substrate are somewhat inelastic, one or more elastic elements may be added to the substrate to adapt the overall elasticity of the patient engagement substrate to the elasticity of the skin. By improving the characteristics in this way, the comfort of the wearable defibrillator can be significantly improved, and long-term wear of the device can be enabled while minimizing skin irritation and patient non-compliance.

[0046] Figure 3 shows a wearable defibrillator 500, which includes an upper patch 502 having two sensor electrodes and a defibrillation electrode, and a lower patch 504 having three sensor electrodes and a defibrillation electrode. The patient engagement substrates of the upper patch 502 and the lower patch 504 include defibrillation pad electrodes and sensing electrodes. The lower patch 504 supports a housing 506 that includes an LED light indicator 508 for providing system feedback. The housing 506 includes a button 510 that can be pressed by the user. The electrodes of the upper patch are connected by a conductive cable 512 to an electronic circuit within the lower patch. The lower patch 504 has a larger surface area than the upper patch 502, and this surface area allows the shear weight of the modules of the electronic circuit (e.g., battery, capacitor, and controller) to be dispersed. The lower patch 504 is arranged to follow the lower rib line of the wearer. The ECG sensors may be uniformly scattered throughout the vector. The housing 506 on the lower patch 504 includes a user interface operating device that is easily accessible to the wearer. In some cases, the upper patch 502 may include a feedback system such as a speaker to improve communication with a wearer with reduced hearing function. In some embodiments, the upper patch may include an override button. In some embodiments, the upper patch may include a speaker and an override button. Also, in some embodiments, the speaker and / or the override button may be on the lower patch. The illustrated cable 512 may include a cable management system that allows the cable connecting the upper patch 502 and the lower patch 504 to have slack or no slack to absorb variations in body size.

[0047] The illustrated patient engagement substrate of the first patch / section and the second patch / section may include an elastic element (e.g., an elastic element) made of a flexible material having an elasticity substantially equivalent to that of the skin. The elastic element can improve the wearability of the defibrillator and enable continuous wearing even during exercise or shower activities. The elastic modulus of the skin typically ranges from 0.42 MPa to 0.85 MPa. The skin typically has an ultimate strength range of 5 MPa to 30 MPa. The elastic element can enable the upper patch 502 and the lower patch 504 to conform to the patient's skin and stretch with the patient's skin, thereby enabling long-term wearing of this wearable defibrillator. In some embodiments, the elastic element may have an average elasticity of from about 0.40 MPa to about 0.90 MPa. In some embodiments, the elastic element includes an adhesive material within the patient engagement substrate. In some embodiments, the adhesive material constituting the patient engagement element or the patient engagement substrate may have an average elasticity of from about 0.40 MPa to about 0.90 MPa. In some embodiments, the defibrillation pad electrodes and the sensing electrodes may have an average elasticity of from about 0.40 MPa to about 0.90 MPa. In some embodiments, the patient engagement substrate has an average elasticity of from about 0.40 MPa to about 0.90 MPa. In some embodiments, the patient engagement substrate has an average elasticity greater than about 0.40 MPa. In some embodiments, the patient engagement substrate has an average elasticity less than about 5.0 MPa. In some embodiments, the patient engagement substrate has an average elasticity less than about 2.0 MPa. In some embodiments, the elasticity of the patient engagement substrate may vary such that it is less elastic near rigid components (such as capacitors, batteries, circuit boards, etc.) like electronic circuits and more elastic in other locations. For example, locations on the patient engagement surface that are not adjacent to the electronic circuit may have an elasticity of from about 0.40 MPa to about 0.90 MPa. By matching the elasticity of the electrodes and the adhesive material to that of the skin, it is possible to improve the comfort of wearing this wearable defibrillator.

[0048] By enhancing the fluid movement characteristics of this wearable defibrillator, it is possible to improve the wearing comfort, skin health, and long-term wearability of this wearable defibrillator. According to some embodiments, this wearable defibrillator includes a fluid movement element configured to move fluid away from the skin. According to some embodiments, the fluid movement element may be configured to enable the wearable external defibrillator to be continuously worn during exercise or shower activities by moving fluid away from the skin. One way to quantify the fluid movement characteristics of this device or a part of this device, for example, the fluid movement element, is the water vapor transmission rate. The water vapor transmission rate may include the transmission rate of fluid and vapor. According to some embodiments, the water vapor transmission rate of the entire wearable defibrillator may be selected to match or exceed the average human transpiration rate. The average human transpiration rate may be about 250 g / m per day 2 as may be. In the case of intense physical activity, moisture can be generated at a maximum rate of about 1100 g / m per hour 2 , but it is unlikely that such a transpiration rate will be sustained for a long time. Embodiments of the wearable defibrillator disclosed herein may be configured to perform fluid movement at a higher transpiration rate required for short periods of intense physical activity. For example, when the transpiration rate is high, the suction layer can move moisture across the entire contact area with the patient. The moisture may be absorbed by the absorption layer, whereby the fluid can pass through the housing at a lower speed and evaporate

[0049] The fluid movement element may be a single material, or multiple materials or structures in this wearable defibrillator. According to some embodiments, the fluid movement element may include a part of the patient engagement substrate. According to some embodiments, the fluid movement element may include an adhesive. According to some embodiments, the fluid movement element may include a fluid movement layer or fluid movement material, such as a suction layer. According to some embodiments, the fluid movement element may include an absorption layer. According to some embodiments, the fluid movement element may include a breathable outer housing

[0050] In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 10 g / m per day. 2 In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 50 g / m per day. 2 In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 100 g / m per day. 2 In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 150 g / m per day. 2 In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 200 g / m per day. 2 In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 250 g / m per day. 2 In some embodiments, the fluid transfer element has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 500 g / m per day. 2

[0051] In some embodiments, the fluid transfer characteristics of the adhesive material can be quantified. In some embodiments, the adhesive material has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 10 g / m per day. 2 In some embodiments, the fluid transfer characteristics of the adhesive material can be quantified. In some embodiments, the adhesive material has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 50 g / m per day. 2 In some embodiments, the adhesive material has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 100 g / m per day. 2 In some embodiments, the adhesive material has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 150 g / m per day. 2 In some embodiments, the adhesive material has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 200 g / m per day. 2 In some embodiments, the adhesive material has an average moisture transmission rate based on the surface area of the patient engagement substrate that exceeds about 250 g / m per day.2 Exceed. The defibrillation pad electrodes and sensing electrodes may also have any of the same water vapor transfer characteristics as the adhesive material.

[0052] The water vapor transmission rate of the patient engagement substrate may be configured to move moisture from the skin. In some embodiments, the wearable defibrillator has a patient engagement substrate, the patient engagement substrate includes an adhesive material, sensing electrodes, and defibrillation pad electrodes, and these moisture transmission rates based on the surface area of the patient engagement substrate are about 250 g / m per day 2 Exceed. The water vapor transmission rate may be the average water vapor transmission amount across the total surface area of the patient engagement surface (e.g., the surface areas of the adhesive material, defibrillation pad electrodes, and sensor electrodes). In some embodiments, the patient engagement substrate has an average moisture transmission rate based on the surface area of the patient engagement substrate of more than about 10 g / m per day 2 Exceed. In some embodiments, the patient engagement substrate has an average moisture transmission rate based on the surface area of the patient engagement substrate of more than about 50 g / m per day 2 Exceed. In some embodiments, the patient engagement substrate has an average moisture transmission rate based on the surface area of the patient engagement substrate of more than about 100 g / m per day 2 Exceed. In some embodiments, the patient engagement substrate has an average moisture transmission rate based on the surface area of the patient engagement substrate of more than about 150 g / m per day 2 Exceed. In some embodiments, the patient engagement substrate has an average moisture transmission rate based on the surface area of the patient engagement substrate of more than about 200 g / m per day 2 Exceed. In some embodiments, the patient engagement substrate has a water vapor transmission rate of more than about 500 g / m per day 2 Exceed. In some embodiments, the patient engagement substrate has a water vapor transmission rate of more than about 1000 g / m per day 2 Exceed.

[0053] The housing can also promote the permeation of water vapor that exits the body of the patient engagement substrate from the surface of the skin, passes through the housing, and exits the wearable defibrillator. In some embodiments, the inner surface of the housing may be permeable to water vapor, such that water vapor can pass through the housing from the interior of the device to the exterior of the device. In some embodiments, due to the inner surface of the housing being permeable to water vapor, water vapor can pass through from the inner surface to the outer surface, and the water vapor permeation rate based on the surface area of the patient engagement surface is about 250 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the patient engagement surface is about 500 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the patient engagement surface is about 1000 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the outer surface of the housing is about 1500 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the outer surface of the housing is about 2000 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the outer surface of the housing is about 5000 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the outer surface of the housing is about 10000 g / m 2 per day or more. In some embodiments, the water vapor permeation rate of the housing based on the surface area of the outer surface of the housing can be as high as about 25000 g / m 2 per day.

[0054] The wearable defibrillator disclosed in this specification may have a multilayer structure that can further improve the long-term wearability of the defibrillator. FIG. 4 is a view showing a portion of the lower patch 600 of the wearable defibrillator 600 from multiple angles according to some embodiments. The top view of the lower patch 600 shows the outer housing 602 and the adhesive border 604. The housing 602 includes two buttons 606. The adhesive border 604 can be used to prevent moisture from entering the space between the skin and the electrodes and defibrillation pads. Also, the adhesive border 604 can be used to prevent the device from being accidentally peeled off due to mechanical wear across the edge of the device. The adhesive border may have a thickness of less than about 0.010 inches. In some embodiments, the adhesive border may have a thickness of about 0.001 inches to about 0.005 inches. Another drawing of the lower patch 600 is an isometric view showing the multilayer structure of the lower patch 600. The lower patch 600 includes a layer 608 configured to contact the patient's skin for long-term wear. The layer 608 that contacts the patient's skin includes an adhesive 610, a sensing electrode, and a defibrillation pad electrode 612 configured to contact the skin for long-term wear. The adhesive 610, the sensing electrode, and the defibrillation pad electrode 612 may include complementary structures that are combined with each other, thereby forming a layer or substrate that contacts the skin. In some embodiments, the adhesive may be part of a fluid transfer element. In some embodiments, the adhesive may be modified to improve fluid transfer characteristics.

[0055] The suction layer 614 may be in contact with a layer 608 that includes one or more of the adhesive material 610, the hydrogel electrode, the sensor electrode, and the defibrillation pad 612. In some embodiments, the suction layer 614 is part of a fluid transfer element. The suction layer 614 can better diffuse fluid from the patient's skin, such as liquid water, water vapor, and moisture, across the entire layer (e.g., the adhesive material and electrodes) that is in contact with the patient's skin. In addition to sucking up fluid across the entire adhesive material and electrodes, the suction layer can also diffuse the fluid across the entire major surface area of the suction layer. The suction layer may have a flexible sheet-like structure that can conform to the desired surface profile of the device and the patient's skin. The major surface area of the flexible sheet-like structure is the surface area of the flat sheet surface of the layer. The major surface area may be either the side of the layer closer to the patient engagement / skin side of the layer or the side of the layer closer to the outer housing side of the layer. By spreading the fluid across the entire major surface area of the suction layer, it is possible to significantly improve the fluid transfer characteristics of the device, which is possible by spreading the fluid over a larger surface area and promoting evaporation and fluid transfer across the entire outer housing. By improving fluid transfer in this way, it is possible to improve the user's comfort and enhance the long-term wearability of the device, which can be achieved, for example, by preventing the patient's sweating from adversely affecting the electrical contact between the sensing electrodes and the defibrillation electrodes and the skin, and by preventing the patient's sweating from interfering with the adhesive properties of the adhesive material. By using the absorption section 616 or multiple absorption sections 616 in combination with the suction layer 614, it is possible to further promote moisture transfer between the skin and the device. In some embodiments, the absorption section may be part of a fluid transfer element. In some embodiments, it is also possible to further promote moisture transfer across the entire adhesive material layer by perforating the adhesive material 610 used in the patient engagement substrate. The perforated adhesive material layer may be part of a fluid transfer element.

[0056] The semi-rigid base chassis 618 can be used to provide additional structural support to the heavier components in the device, such as the electronic circuits of the device. The illustrated chassis may have an electronic circuit module 620 or a plurality of modules mounted to the chassis 618. In the illustrated defibrillator, a mounting frame 622 is used to mount the electronic circuit 620 to the chassis 618. This electronic circuit may be housed in one or more waterproof housings within the housing of the device. This electronic circuit may be connected to the sensor electrodes and defibrillation pads using a flexible conductive material that can be routed through the multilayer structure of the device. Examples of materials that can be used for the semi-rigid chassis 618 include, for example, polyester, polyethylene, polystyrene, polyurethane, vinyl, and the like.

[0057] The housing 602 may be flexible. In some embodiments, the flexible housing may be used to hold the device together. Additionally, the flexible housing may be elastic. The housing may be resistant to shock, tearing, dirt, chemicals, and bacteria. The outer surface of the housing may be low friction to reduce wear and the likelihood of snagging on clothing or objects. In some embodiments, the outer surface of the housing may be water resistant. In some embodiments, the outer surface of the housing may be hydrophobic. The housing may be waterproof so that water does not pass through the housing and enter the interior of the device. In some embodiments, the housing may be permeable to air. Examples of materials that can be used for the housing include, for example, a cloth based on polyester or polyurethane. This cloth may be a knitted, woven, or non-woven fabric. In some embodiments, the housing may be part of a fluid transfer element.

[0058] The properties of the individual layers may be selected to achieve a wearable defibrillator having the desired mechanical, strength, flexibility, adhesion, electrical, and chemical properties.

[0059] FIG. 5 shows an embodiment 700 of a portion of a wearable defibrillator having a multilayer structure. FIG. 5 shows each individual section of sensor electrode hydrogel 702, defibrillation electrode hydrogel 704, and adhesive 706, which are combined and arranged in the form of one substrate having a generally flat layer or shape and having complementary shapes so that the sensor electrode hydrogel 702, defibrillation electrode hydrogel 704, and adhesive 706 can be arranged, whereby each of the sensing electrode, defibrillation pad electrode, and adhesive can conform to the patient's skin. The patient engagement substrate includes sensor electrode hydrogel 702, defibrillation electrode hydrogel 704, and adhesive 706 and is configured to contact the patient's skin and be suitable for long-term wear. The sensor electrode hydrogel 702 may be arranged as a plurality of discrete electrodes to detect or acquire cardiac signals at various contact points. The defibrillation electrode hydrogel 704 has a larger surface area to make sufficient contact with the skin while delivering a defibrillation energy pulse. The adhesive 706 may be a strong adhesive breathable adhesive. In some embodiments, the adhesive 706 may be a perforated gel as shown in FIG. 5 to improve the breathability and / or moisture transfer characteristics of the adhesive. The hydrogels used for the defibrillation electrode hydrogel 704 and the sensor electrode hydrogel 702 may be adhesive to make better electrical contact with the skin and to further structurally support the device.

[0060] The adhesive may be selected to support the weight of the wearable defibrillator throughout the duration of activity for a period of 10 to 14 days. Also, the adhesive may be selected to be comfortable, non-irritating, and easy to remove with respect to moisture management. In some embodiments, a plurality of different types of adhesives may be used. Examples of types of adhesives that can be used include, for example, hydrocolloids, silicones, acrylics, polyolefins, etc. Hydrocolloid adhesives typically have high strength but are difficult to peel off. Silicones have sufficient strength and are easy to peel off. Combining perforated silicone with a wicking layer makes it possible to achieve excellent moisture transfer characteristics while maintaining adhesion to the skin.

[0061] The conductive electrode film 708 is illustrated. The conductive electrode film 708 may be in electrical communication with one or more of the sensing electrode 702 and the defibrillation electrode hydrogel 704. In some embodiments, a flexible circuit may be formed by laminating the conductive electrode film 708 to a support structure such as a polyester (PET) chassis 710. In some embodiments, the additional sensors described herein may be fabricated within this flexible circuit, thereby simplifying manufacturing. FIG. 5 shows the support structure 710. The support structure 710 may be used to support the electronic circuitry of the device and to distribute the shear load of the device across the footprint of the device. The support structure 710 may be semi-rigid to support the electronic circuitry and improve weight distribution. A moisture transfer material 712 may be used to improve moisture movement from the electrodes and adhesives of the device outwardly of the device. The moisture transfer material 712 may be a wicking fabric. Examples of wicking materials include materials such as cotton, polyester, non-woven structures, etc. The moisture transfer layer may wick moisture from the skin through the adhesive and hydrogel. In some embodiments, the moisture or fluid transfer layer has an absorption capacity of greater than about 500%. In some embodiments, the fluid transfer layer or wicking layer may be a non-woven fabric that is a mixture of polyester and cellulose. In some embodiments, the ratio of cellulose to polyester may be from about 45 / 55 to about 65 / 35, and the basis weight is 30 - 120 g / m 2 2. In one example, this layer is a 50 / 50 mixture of cellulose and polyester, with a basis weight of 70 g / m 2 2, and an absorption capacity of about 850%.

[0062] The outer housing material 714 is illustrated. The outer housing material 714 may be made of a breathable and somewhat water-resistant fabric, laminate, or other material or structure. The outer housing material 714 may be flexible and abrasion-resistant to reduce friction between the outer housing material and the clothing. Examples of the outer housing material 714 include non-woven fabric, laminated structure, laminated fabric structure, etc. In some embodiments, a non-woven polyurethane fabric material may be used as the outer housing. The laminated structure may include an outer layer, a membrane layer, and an inner layer. The materials of the outer layer, the membrane layer, and the inner layer may be selected to provide a breathable laminated structure with a hydrophobic outer surface that provides water resistance. In some embodiments, the outer housing material is water-resistant. In some embodiments, the outer housing material is hydrophobic. In some embodiments, the outer housing material is waterproof.

[0063] The outer adhesive border 716 is illustrated. The adhesive border 716 is connected to the outer periphery of the device and is configured to enhance the adhesion between a portion of the wearable defibrillator and the patient's skin by adhesively engaging the skin. The adhesive border 716 may be made of a thin, flexible non-woven polyurethane and a strong adhesive. The adhesive border 716 can prevent water from passing through from the outside of the device to the area between the electrode and the patient's skin by forming a substantially waterproof sealant between the outer periphery of the device and the patient's skin. The adhesive border 716 may have a tapered cross-section as shown at 818 in FIG. 6.

[0064] FIG. 6 shows a cross-section of a portion of a wearable defibrillator according to some embodiments. The patient contact substrate includes an adhesive 802 and a hydrogel for defibrillation pad electrodes 804 and sensing electrodes 806. A conductive layer 808 provides electrical communication between the electronic circuit module and the hydrogel electrodes 804, 806. The patient contact substrate includes a breathable wicking layer 810 that operates as a moisture transfer element to improve moisture transfer across the hydrogel electrodes 804, 806 and the adhesive 802. The electronic circuit module 812 may be encapsulated within a water-resistant or waterproof housing 814. A support layer (not shown) may be used to distribute the shear weight of the electronic circuit module between the wicking layer 812 and the housing 614. An electronic circuit housing mount 815 may optionally be used to mount the electronic circuit to the device or an optional support layer. The support layer may be on the electrode side or the outer housing side of the electronic circuit module 812, or both. The outer housing material 816 may be made of a water-repellent and breathable material. These layers may be welded together along the outer periphery of the device. A thin polyurethane adhesive film 818 may be used along the outer periphery of the device to enhance adhesion. The thin adhesive film 818 can conform the outer shape of the device along the edges such that the cross-section of the device tapers towards the outside of the device. By tapering in this way, it is possible to reduce the likelihood that the edges of the device will curl up or catch on clothing or other objects, damaging the sealant of the adhesive border 818.

[0065] Figure 7 shows an embodiment 900 of a wearable defibrillator. The wearable defibrillator includes a first portion or patch 902 and a second portion or patch 904. The first portion 902 has a patient engagement substrate that includes defibrillation pad electrodes and sensor electrodes. The second portion 904 has a patient engagement substrate that includes defibrillation pad electrodes and sensor electrodes. The first portion 902 and the second portion 902 may be connected by a cable bridge 906 as shown in Figure 7. The cable bridge 906 may be flexible, extensible, and / or adjustable to absorb variations in the patient's body structure. The illustrated first portion 902 includes an electronic circuit module 908 and a housing 910. The illustrated electronic circuit module 908 includes a first compartment 912 and a second compartment 914 that are in electrical communication. The first and second compartments 912, 914 are configured to hold a battery, a controller, and a capacitor. The illustrated housing 910 is configured to enclose the electronic circuit module 908 within the housing 910 by being connected to the first portion 902 of the wearable defibrillator. The housing material may have one or more of the characteristics of water resistance, tear resistance, stain resistance, antimicrobial resistance, flexibility, chemical resistance, moldable / formable, smooth outer surface, and hydrophobic outer surface. In some embodiments, the housing may have a waterproof outer surface and an inner surface that is permeable to water vapor and liquids, such that water can pass through the housing and flow out to the exterior of the device. The electronic circuit module may have a shock-resistant, water-resistant, and lightweight rigid housing. The electronic circuit module may include LED functionality and button functionality. The first and second portions may be made of a material having one or more of the characteristics of breathability, antifungal resistance, antimicrobial resistance, hydrophobicity, opaque, translucent, colored, laminated multi-layer structure, etc. The first and second portions may be co-molded. The multi-layer structure may include routing of the electronic circuits and may support flexible circuits and interconnects.

[0066] Figure 8 shows an embodiment 1000 of a wearable defibrillator. The wearable defibrillator 1000 has an upper patch 1002 with a patient engagement substrate, and the patient engagement substrate includes two ECG sensing electrodes 1004 and a defibrillation pad electrode 1006. This wearable defibrillator has a lower patch 1008 with a patient engagement substrate, and the patient engagement substrate includes three ECG sensing electrodes 1010 and a defibrillation pad electrode 1012. The lower patch includes an electronic circuit module. The electronic circuit module includes a controller, a capacitor, and a battery. The battery is capable of charging the capacitor, and by delivering electrical energy from the capacitor to each defibrillation pad, electrical treatment is performed on the patient wearing this wearable defibrillator.

[0067] Figures 9 and 10 show an embodiment 1100 of a wearable defibrillator. Each electrode shown in Figures 9 and 10 indicates its relative position on the patient, but the electrodes themselves are on the side of the wearable defibrillator 1100 that contacts the skin. The wearable defibrillator 1100 has an upper patch 1102 with a patient engagement substrate, and the patient engagement substrate includes two ECG sensing electrodes 1104 on both sides of the defibrillation pad electrode 1106. The wearable defibrillator 1100 has a lower patch 1108 with a patient engagement substrate, and the patient engagement substrate includes a defibrillation pad electrode 1110 and three ECG sensing electrodes 1112 spaced across the surface area of the device. The lower patch includes an electronic circuit module 1114.

[0068] Figures 11 through 13 show three types of outer shapes of embodiments regarding the shape of the lower patch. Each of their lower patch arrays includes a patient engagement substrate, and the patient engagement substrate has three ECG sensor electrodes and a defibrillation pad electrode on a substrate configured to contact the user's skin. FIG. 11 shows a lower patch 1200 having a patient engagement substrate, and the patient engagement substrate has a defibrillation pad electrode 1202, an adhesive 1204, and an adhesive border 1206. FIG. 11 shows a perspective view of an electronic circuit housing, and the capacitor 1208 has a semi-circular cross-section. FIG. 12 shows a lower patch 1220 having a patient engagement substrate, and the patient engagement substrate has a defibrillation pad electrode 1222, an adhesive 1224, an adhesive border 1226, an ECG sensor electrode 1228, and a housing 1230. FIG. 13 shows a lower patch 1240 having a patient engagement substrate, and the patient engagement substrate has a defibrillation pad electrode 1242, an adhesive 1244, an adhesive border 1246, an ECG sensor electrode 1248, and a housing 1250. These lower patches have different shapes of defibrillation electrode pads respectively, and each defibrillation electrode pad is configured to apply a defibrillation pulse of electrical energy to the user's skin. The lower patch can utilize a patch shape and a housing shape that conform to the body contour and can move with the body during wearing. The patch and the housing may have a compact component configuration that is shaped to follow the rib line for more stable long-term wearing and adhesion. The patch may be worn so as to extend horizontally under the arm. It is desirable that the housing does not extend horizontally under the arm. This is because in an extended configuration, it may increase the discomfort of the wearer during sleep. Since the skin is not clearly demarcated on the chest wall, the housing may be disposed on the chest wall. The lower patch and the housing may be arranged so that when the user wears it, the housing flows and fits within the chest wall line to minimize the visibility of the device. Depending on the embodiment, each patch may have a fluid movement element and / or an elastic element as described above.

[0069] In embodiments of the wearable defibrillator disclosed herein, capacitors having various shapes and cross-sections may be used. In some embodiments, in the wearable defibrillator disclosed herein, circular aluminum capacitors, flat pack aluminum capacitors, and semi-circular tantalum / aluminum capacitors may be used. To provide the desired voltage and capacitance to this wearable defibrillator while being small and lightweight, multiple capacitors may be used. Six standard circular aluminum capacitors can provide the electrical characteristics required for the capacitor bank. Four custom circular aluminum capacitors can provide the electrical characteristics required for the capacitor bank. Four custom circular aluminum capacitors can provide the electrical characteristics required for the capacitor bank. Five custom circular aluminum capacitors can provide the electrical characteristics required for the capacitor bank.

[0070] Figures 16 through 17C show side external views of the housing shape used in an embodiment of a wearable defibrillator. The housing and the outline of the hardware within the housing may be designed to conform to the size and shape of the patient's torso. To increase the flexibility of this wearable defibrillator and to increase its adaptability to the patient's torso, the housing 1600 and the hardware may be housed in a plurality of compartments 1602, 1604 as shown in Figure 16. The housing may be made of a flexible material so that it is flexible and can reflect the outer shape of the patient's torso. The electronic circuit and the capacitor 1606 may be arranged to follow the contour of the torso and to minimize the overall thickness of the product. The housing may be mounted on the patch so that it fits within the range of the rib line for better adaptation and support.

[0071] Figures 17A through 17C show some embodiments of the arrangement of capacitors and housings with respect to the torso 1708 and the arm 1709. The size and configuration of the capacitors may be selected such that the housing remains small and, if possible, does not interfere with the arm. For example, the housings may be arranged to limit or minimize the outer profile of the housing that extends under the arm. Figure 17A shows a cross-section of an apparatus 1700 having a first housing section 1702 and a second housing section 1704. The first housing 1702 and the second housing 1704 include a commercially available capacitor 1706. Figure 17B shows a cross-section of an apparatus 1710 having a first housing section 1712 and a second housing section 1714. The first housing 1712 and the second housing 1714 include a custom capacitor 1716. Figure 17C shows a cross-section of an apparatus 1720 having a first housing section 1722 and a second housing section 1724. The first housing 1722 and the second housing 1724 include a custom capacitor 1726.

[0072] Figures 28A through 28D show various lower patch shapes according to some embodiments and how the lower patch and housing can be arranged for a female user. Figure 28A shows a lower patch 2800 and a housing 2804 in a position where new clothing and tension can be felt, along with a clothing line 2802. Depending on the embodiment, a layered structure adjacent to these areas may be reinforced or strengthened to improve the resistance of the clothing.

[0073] Figure 28B shows the lower patch 2810 having an electronic circuit housing 2812. The lower patch of the present wearable defibrillator may be designed to be disposed on the thoracic cage under a female user's bra such that, as shown in FIGS. 28C and 28D, the housing extends under the bra 2814. The present wearable defibrillator may be designed to avoid the underwear area to improve the overall wearing comfort. The present wearable defibrillator may be designed to be unisex and may be adjustable to one size that fits all body types. The present wearable defibrillator may include a shape target on the housing or patch to notify the user of the correct placement and guide the user to place the defibrillation pads in the correct area.

[0074] Figures 29A through 29C, and Figures 30A through 30C show various cable designs that can be used between a lower patch and an upper patch. The cable section connecting the upper patch and the lower patch may be designed to be flexible, stretchable, and serve as a joint between the upper patch and the lower patch. Also, to minimize interference with clothing and undergarments, the cable section may be designed to be flat. In one example, the wire may be a braided wire that can move and stretch freely as needed. To not overly irritate the skin, the cable section may have a tapered structure along the sternum. To minimize the tension between the upper patch and the lower patch, the cable section may have elasticity. In some embodiments, the cable section may include an elastic multi-core cable within a waterproof sleeve. In some embodiments, the wiring may accommodate excess wiring. Figure 29A shows a wearable defibrillator 2900, which has an upper patch 2902, a lower patch 2904, and a cable section 2906 having an exposed cable system that hangs freely. Figure 29B shows a wearable defibrillator 2910, which has an upper patch 2912, a lower patch 2914, and an integrated cable 2916 that can slide within a flexible casing. Figure 29C shows a wearable defibrillator 2920, which has an upper patch 2922, a lower patch 2924, and a braided cable 2926 within a flexible casing 2928. Figure 30A shows a wearable defibrillator 3000, which has an upper patch 3002, a lower patch 3004, and a cable 3006 within a slidable adjustment sleeve 3008. Figure 30B shows a wearable defibrillator 3010, which has an upper patch 3012, a lower patch 3014, and a cable section 3016 that may extend from an intermediate portion of the lower patch to avoid the sternum. Figure 30C shows two braided cable patterns 3020, 3022 that can be used with any embodiment of the wearable defibrillator disclosed herein.

[0075] Figures 31A through 31D show various form factors of the upper patch according to several embodiments, along with examples of the placement of the upper patch on the chest of a female user. FIG. 31 shows upper patches 3100, 3102, and 3104. FIG. 31B shows the upper patch 3100 placed on the chest of a female user. FIG. 31C shows the upper patch 3102 placed on the chest of a female user. FIG. 31D shows the upper patch 3102 placed on the chest of a female user. The shape of the upper patch may be optimized to fit the wearer's chest. The upper patch may be shaped to minimize overlap with bra straps and other types of ordinary undergarments. Typically, the wearable defibrillator disclosed herein is configured to be used by both men and women, but in some embodiments, the upper patch and the lower patch may be configured to be specialized for the body structures of men or women with different sizes and shapes.

[0076] FIG. 32 shows various housing shapes and designs that can be used with the wearable defibrillator disclosed herein. These various housing shapes have various arrays of operation buttons. The housing 3210 shown in FIG. 32 has a button 3212 on the side of the housing. The housing 3220 shown in FIG. 32 has a button 3222 on the side of the housing. The housing 3230 shown in FIG. 32 has a button 3232 on the side of the housing. The housing 3240 shown in FIG. 32 has a button 3242 on the front of the housing. The housing 3250 shown in FIG. 32 has a button 3252 on the front of the housing. These two operation buttons may require simultaneous pressing for input to avoid accidental pressing or contact. These buttons may be ergonomically arranged so that they are easily accessible for the wearer to pinch or press simultaneously. The housing may be contoured to guide the wearer's finger to the button. Also, since the buttons on the housing may be hidden by the clothing worn on the housing, the housing may include surface protrusions or contours that assist in guiding the wearer to the button.

[0077] If electrical contact between the electrode and the patient's skin is continuously maintained, skin impedance may increase due to the formation of skin eschar. One way to minimize problems associated with skin eschar formation is to move the electrodes around after about 10 - 14 days, or at least once during the first month of use.

[0078] In some embodiments, a passive electrode array may be employed. For example, a hydrogel may be continuously contacted with the skin. The hydrogel may be modified to enhance compatibility with the skin and to reduce skin irritation. For example, the hydrogel may be hydrated, or may be adapted to the elasticity of the skin, or may be made to match physiological parameters of the skin, including pH and moisture transfer. Further, the hydrogel excludes chemicals that degrade the skin, such as shampoo, that can attack the lipids of the stratum corneum.

[0079] The electrode can conform to the body. The electrode may be designed to conform to a particular biological structure of the body.

[0080] In some embodiments, the elasticity of the electrode is modified to conform to the elasticity of the skin. By adapting the elasticity of the electrode to the skin, it is possible to reduce skin irritation and improve the wearing comfort of the electrode for long - term wear. In some embodiments, the electrode may have a spiral design. In some embodiments, the electrode may include slits or hinges so that it can curve or bend while remaining adhered to the skin. In some embodiments, a material may be added on the electrode. This material may be added to modify the properties of the electrode. For example, a hydrogel or an electrode gel (e.g., AgCl or Sn) may be applied to the electrode to improve heat dissipation and limit resistive heating of the tissue.

[0081] According to some embodiments, a defibrillation pad suitable for long-term wear is provided. For example, a patient engagement surface may include one or more sensing electrodes configured to engage the patient's skin to detect a cardiac signal, a defibrillation electrode pad configured to engage the patient's skin and deliver an electrical therapy to the patient and to be in continuous electrical communication with the patient's skin, an adhesive, the one or more sensing electrodes, the defibrillation electrode pad, and a fluid movement element, and a patient engagement substrate including the same. The fluid movement element is configured to move fluid away from the skin to enable the wearable extracorporeal defibrillator to be continuously worn even during movement or shower activities.

[0082] According to some embodiments, the defibrillation pad electrodes used in the wearable defibrillators described herein may include a hydrogel and a carbon fiber fabric structure. The carbon fiber fabric electrode structure can conform to the skin and deliver electrical energy to the skin during a defibrillation shock. An adhesive border may be used around the hydrogel-carbon fiber defibrillation pad to minimize edge lift and moisture ingress.

[0083] The electrode design may be selected to maintain the local environment between the skin and the electrode. For example, the electrode design may be such that it limits water ingress during showering and prevents water from leaving the hydrogel or other electrode material. Proper hydration of the skin and hydrogel may be maintained to improve electrical contact and skin health for long-term wear. Dehydration of the hydrogel can lead to an increase in the impedance at the interface between the electrode and the patient. Shampoo and soap can also modify the properties of the hydrogel and the adhesive. A barrier may be used to prevent shampoo and soap from modifying the electrode properties. According to some embodiments, the electrode may include a substance that degrades the stratum corneum, such as soap. According to some embodiments, the adhesive border may be used to limit the ingress of water and substances into the environment between the electrode and the skin. The adhesive border may be around the perimeter of the outer periphery of the patch and / or around the perimeter of each of the individual defibrillation pad electrodes and sensing electrodes.

[0084] This wearable defibrillator may include a structure for monitoring the electrodes so that the electrodes are properly in contact with the correct location on the patient's skin, for example, an electrode monitoring structure. For example, capacitance and / or impedance may be detected by the system to determine whether the electrodes are adhered to the patient completely and / or at an appropriate location in order to enable the delivery of an effective defibrillation pulse during arrhythmia.

[0085] Another option for minimizing skin irritation due to continuous contact of the electrodes or minimizing impedance changes associated with skin eschar formation is to use electrodes in which the electrical contact with the skin is not continuous. In some embodiments, the long-term wear electrodes may be active electrodes capable of releasing a gel to make better electrical contact with the patient's skin. The gel may be a conductive material. This design also has less impact on the increase in impedance due to skin eschar formation. This is because the electrical contact with the skin is made just before the delivery of the defibrillation pulse. Further embodiments of the active electrodes will be described later.

[0086] A further structure for providing a conductive material for the active electrodes is disclosed herein. In some embodiments, the electrode is adhered to the skin such that a predetermined space is formed between the skin and the electrode. A conductive material is provided between the electrode and the skin to enhance the conductivity therebetween. Other mechanical or chemical configurations may be used to enhance the conductivity between the electrode and the skin.

[0087] In some embodiments, a hydrogel may be provided as the conductive material. The hydrogel may be activated by heat, by pressure (vacuum or positive pressure), by voltage, or may be provided in the space between the electrode and the skin by other means.

[0088] In some embodiments, microfluidics may be used to deploy the conductive material. For example, instead of spraying the conductive material, microfluidics, suction, and capillary action may be used to deploy the conductive material.

[0089] Additional options for deploying the conductive gel include electroporation, melting / burning of the sacrificial layer, phase transition, piercing / tearing of the sacrificial barrier layer, extrusion, vacuum, pressure, electric field, magnetic field, heating, mechanical means (e.g., pumps or springs), chemical means (e.g., osmotic pressure or reactions), ultrasonic ejection, and the like.

[0090] The sodium content or other salt content of the electrode is a further concern in design. An increase in the sodium content or other salt content may cause the skin to dry out through osmotic diffusion. In some embodiments, it is possible to suppress skin dryness by minimizing the content of salts such as sodium (or selecting to achieve isotonicity).

[0091] In some embodiments, an eluent may be used with any of the electrodes disclosed herein. The eluent can lower the impedance in long-term wear. In one example, a steroid may be eluted.

[0092] The outer layer of the skin (stratum corneum) may be of low conductivity. In some embodiments, the electrical contact between the electrode and the skin can be enhanced by removing or penetrating the stratum corneum. Microneedles may be deployed to penetrate the stratum corneum before delivering the defibrillation pulse. The top layer of the skin may be removed before delivering the defibrillation pulse. Another option is to impede the growth of that layer by controlling the removal rate of dead skin cells or the outer layer of the skin. By removing the outer layer of the skin or achieving electrical contact with the body under the outer layer of the skin, it is possible to lower the transthoracic impedance between the electrode and the patient. Another option is to deliver a short electrical spike before the defibrillation pulse to lower the thoracic impedance.

[0093] A variety of configurations may be used for long-term ECG monitoring electrodes. To minimize complex motion artifacts, a structure that isolates the monitoring electrode from the device assembly may be used. The electrode may be of a flat shape design to minimize curling and may be shaped to conform to the device. The electrode may be on the outer surface of the device and may include an outer sliding layer to minimize external physical interference with clothing and / or during sleep.

[0094] For long-term attachment of the device to the body, various adhesion designs may be used. The adhesive may be designed such that the weight of the device and the shear force are distributed across the entire adhesive area. In some embodiments, the adhesive is selected such that major skin irritation symptoms, such as redness (erythema), swelling (edema), skin sensitization, etc., do not occur. Other design considerations regarding the adhesive include the mobility and flow rate of the adhesive, as well as the adhesiveness, peel adhesion force, and shear strength of the adhesive. In some embodiments, the surface energy of the adhesive is less than the surface energy of the skin and is typically 28 dyn / cm 3 before and after. Various skin adhesives and their properties are shown in FIG. 14 and include acrylates, silicones, hydrocolloids, acrylics, natural rubbers, synthetic rubbers, polyolefins, and polyurethanes.

[0095] In some embodiments, the type and configuration of the adhesive may be selected based on the water vapor transmission rate. In some cases, perforations or openings may be made in the adhesive to increase the water vapor transmission rate. The perforated holes may have a diameter of about 0.5 mm to about 2 mm. The perforated holes may be of a substantially uniform shape or may vary in size and shape. In some embodiments, the adhesive may include an open cell structure. The total opening area may be selected such that the adhesive portion of the device achieves the desired properties, such as water vapor transmission rate. In some embodiments, the opening area of the perforated holes is about 10% to about 25% of the total surface area of the adhesive. In some embodiments, a suction layer may be used to further increase the water vapor transmission rate. An absorbent may also be used to increase the water vapor transmission rate.

[0096] The weight and form factor of the device affect the wearing period and comfort of the device. The wearing period is inversely proportional to the weight of the device. FIG. 15 shows data on the relationship between the adhesive load and the wearing period for various weights. In some embodiments, the hydrogel electrode can further support the device by adhering more firmly to the skin.

[0097] In some embodiments, the adhesive is designed to attach the wearable defibrillator to the patient's skin for 10 to 14 days without significant skin irritation. After 10 to 14 days, the adhesive may be replaced, or the position of the device may be shifted so that the adhesive contacts another area of the patient's skin. In some embodiments, the adhesive may be designed to be used for up to about one month (approximately 30 days), after which the adhesive may be replaced or the device may be shifted.

[0098] In some embodiments, the device may include a replaceable adhesive pocket. The adhesive pocket may be replaced after the end of a specific usage period. The replaced adhesive pocket may be used to support the wearable defibrillator by contacting various areas of the patient's skin. The adhesive pocket may be replaced periodically to achieve the total wearing period of the defibrillator.

[0099] In some embodiments, the device may have an adhesive shape configured to adhere to alternating positions on the body each time the device is applied. For example, the adhesive may be used in a checkerboard (A / B) configuration or may be rotationally symmetric. As shown in FIG. 87, the device may be rotated periodically to minimize skin irritation while maintaining contact between the electrodes and the skin. In the configuration shown in FIG. 87, it may be rotated by about 60° to change the area where the adhesive contacts the skin in order to minimize skin irritation.

[0100] In some embodiments, the device includes a structure that protects the edge of the adhesive material (e.g., the edge of the hydrophilic colloid adhesive material) from peeling or coming off the skin. This structure can prevent or minimize water from contacting the edge during a shower. To minimize the possibility of the edge sticking to clothes or other objects, the edge may be configured to be flat.

[0101] In some embodiments, a thin polyurethane layer with an adhesive is used to protect the edge of the device from contacting water. By maintaining the dryness of the adhesive layer and the area between the device and the user's skin, it is possible to improve the long-term wearing comfort.

[0102] In some embodiments, a silicone adhesive material that can operate well with respect to contact with water may be used instead of materials such as hydrophilic colloid adhesive materials.

[0103] The adhesive material may be selected or arranged to absorb or allow for the elongation of the skin.

[0104] In some embodiments, two or more types of adhesive materials may be used. These adhesive materials may be arranged in a pattern such as a plurality of rings or an alternating pattern. Since stronger adhesive materials may be more likely to cause skin irritation, alternating a strong adhesive material with a low-strength adhesive material can improve the wearing comfort and long-term wearing.

[0105] In some embodiments, together with the hydrophilic colloid, a chemical substance or substance that reduces the adhesiveness of the hydrophilic colloid and reduces skin irritation may be used.

[0106] In some embodiments, ultrasonic sewing may be performed to ultrasonically weld the device to the skin so that the device can be semi-permanently attached to the user.

[0107] In some embodiments, the adhesive material may be arranged like the layers of an onion, and this onion-layered adhesive material peels off over time.

[0108] In some embodiments, the wearable defibrillator may be configured such that the outer sliding layer of the device can be periodically replaced while the device remains in a fixed position. The sliding layer may be designed to minimize interference between the outer layer of the device and clothing and other objects.

[0109] The wearable defibrillator may be provided with a material that can be used to reliably remove the adhesive from the skin. In one example, an adhesive remover may be injected by the device. The adhesive and the device may be removed after a specified period.

[0110] Prior to attaching the wearable defibrillator, pre-treatment of the patient's skin may be performed so that the wearable defibrillator makes better contact with the patient's skin. In one example, automated procedures such as ultrasonic skin exfoliation may be performed as pre-treatment of the skin. In another example, prior to attaching the wearable defibrillator, pre-treatment of the skin may be performed using a skin cleansing agent. A structure for attaching and peeling off may be provided. The structure for attaching and peeling off may be removed after being attached to the skin. The adhesive attached to the structure for attaching and peeling off can remove dirt, oil, and skin cells.

[0111] In some embodiments, the wearable defibrillator may be provided to the patient as part of a kit. The kit may include items such as an adhesive remover, a skin cleanser, a hair removal tool, a tool for attaching the wearable defibrillator, and instructions for attaching the wearable defibrillator. The tools may include tools that can simplify the attachment operation by the patient, such as enabling operation with both hands. The tools may include, for example, a strap harness for holding the device near the body so that the device can be attached with both hands, a molded carrier frame, and a template. Further, the tools may include, for example, a projection template or a mirror template that can be used to assist the patient in properly orienting the device by aligning its orientation to fit the placement of the device on the body.

[0112] A skin cleansing tool and a hair removal tool may also be provided together with the present device. For degreasing the skin surface, a wiping cloth containing alcohol may be used. According to an embodiment, a cleansing material that can be used to cleanse the skin surface and attach the present device may be provided to a disposable glove. This glove may have a solvent such as alcohol on its surface. In another case, the glove may have a rough surface or a fastening surface for accommodating a replaceable cleansing pad. As another skin cleansing tool, there is a hair removal strip. As another example of a hair removal tool, there is a disposable razor. By using these tools in order, hair can be removed, the skin surface can be scrubbed, the skin can be cleansed, and then the present device can be attached.

[0113] The packaging of the present device may incorporate a support function that helps the user somehow perform various attachment procedures. For example, an instruction guide may be incorporated into the box. A video may be provided to guide the user to attach the present device correctly.

[0114] According to an embodiment, first, a doctor or a medical professional attaches an electrode to the patient's skin and then attaches the present device. The position or orientation of the present device on the patient's body may be changed every about two weeks to minimize skin irritation. For subsequent removal and attachment of the device, a caregiver, a spouse, or the patient may attach the electrode and the device. The present device may include clear instructions for the accurate positioning of the electrode and the device. The present device may also detect the position of the present device during the placement of the present device and give feedback or an alert to the user. The feedback may be given by illumination on the device, an auditory instruction, a tactile instruction, vibration, or another type of feedback. In some cases, the pre-treatment of the skin before attachment may include cleansing and shaving the skin area before attaching the electrode.

[0115] This wearable defibrillator may have high reliability and may be ready to deliver a defibrillation pulse within about 10 seconds. Each component of this wearable defibrillator may be capable of delivering a set maximum number of shocks to a patient. In some embodiments, the device is configured to deliver at least 10 shocks to a patient. The device may also measure transthoracic impedance, may be suitable for long-term wear, may have good comfort and conform to the body, may be of a flat shape, and may have a function to evaluate the contact between the electrodes and the skin. This wearable defibrillator may also take an intentionally longer time (any time between 10 seconds and up to 1 minute) before performing defibrillation, and during that time, further analysis may be performed to increase the accuracy of the decision to deliver a defibrillation shock. This additional time may anticipate the possibility that, depending on the arrhythmia, it may self-terminate and the shock may become unnecessary.

[0116] This wearable defibrillator may include an ECG electrode, a defibrillation electrode, a contact detection element for determining whether the defibrillation electrode is in contact with the skin, a defibrillation circuit, an ECG circuit, a battery, a capacitor, power management, wireless communication, a user interface element, operating software, and any additional structures and additional functions described herein.

[0117] For the ECG monitoring device, this wearable defibrillator may use a two-wire electrode system having 2 to 4 sensing electrodes, or a three-wire system having 6 or more sensing electrodes may be used.

[0118] The battery and electronic components may be considered part of the low-voltage block, and the capacitor may be considered part of the high-voltage block. The battery is used to charge the capacitor before delivering the defibrillation pulse. The battery can store a large amount of energy while keeping the weight low. In some embodiments, a battery similar to that of a mobile phone may be used. In some embodiments, a secondary battery may be used. In some embodiments, a primary battery may be used. The weight of the battery may vary between about 50 grams and about 150 grams. In some embodiments, the weight of the battery may be from about 50 grams to about 100 grams. Depending on the specific components used, as well as the sampling frequency and other device settings, various batteries may be used.

[0119] A wearable device worn near the body (e.g., attached by adhesion) must be in a flat shape, have a low weight density, and be able to withstand daily physical activities such as exercise, shower, and sleep. A safety mechanism may be used to reduce failure modes caused by factors such as water ingress and physical shock. The capacitor used in the wearable defibrillator disclosed herein provides a mechanism for storing and releasing electrical energy. This mechanism exhibits high power density, high energy density, physical toughness, and low weight density, and can be safely worn near the body.

[0120] The capacitor disclosed herein and used in this wearable defibrillator has a capacitance of more than 400 μF, a rated voltage of more than 350 V, a compact volume, and a density of about 2.5 g / cm 3 It is possible to meet one or more of the following design conditions.

[0121] The materials, configurations, and characteristics of various types of capacitors are shown in FIGS. 15, 18 to 27. FIG. 15 shows the shapes and cross-sections of various capacitors that can be used in an embodiment of the wearable defibrillator disclosed in this specification. FIG. 15 shows two types of circular aluminum capacitors, a flat-pack aluminum capacitor, and a semi-circular tantalum / aluminum capacitor. A plurality of capacitors may be used to provide the desired voltage and capacitance to the wearable defibrillator while being small and lightweight.

[0122] FIG. 18 shows the materials, types, and configurations of various types of capacitors. FIG. 19 shows the relationship between the voltage and capacitance of various types of capacitors. FIG. 20 is a chart listing various capacitor characteristics of capacitors that can be used in the device disclosed in this specification. FIG. 21 shows a wet / wound type aluminum capacitor 2100, which has a cathode 2102, an anode 2104, a dielectric 2106, an electrolyte 2107, and paper 2108 immersed in the electrolyte. FIG. 22 shows a capacitor 2200, which has a cathode 2204, an anode 2202, a dielectric 2208, and an electrolyte support 2206. FIG. 23 shows a wet tantalum capacitor 2300, which has a cathode 2302, an anode lead 2304, a tantalum anode 2306, and an electrolyte 2308. FIG. 24 shows a Q-capacitor 2400, which has an anode 2402 and a space 2404 between the anodes 2402. FIG. 25 shows a multilayer capacitor 2500, which has a dielectric or electrolyte support 2502 and a conductive foil 2504. FIG. 26 shows a capacitor 2600, which shows a cathode 2602, an anode 2604, a dielectric 2606, and a foil 2608. FIG. 27 shows various capacitor configurations 2702, 2704, 2706 that can be used to generate a voltage of 1800 V and a capacitance of 100 μF.

[0123] Depending on the embodiment, a wet / electrolytic tantalum capacitor or a wet / electrolytic aluminum capacitor may be used. Capacitor configurations according to some embodiments are shown in FIGS. 21 to 24.

[0124] Examples of capacitor configurations include configurations such as roll, sandwich, and stacked. A wet tantalum capacitor may have an operating voltage of about 125V. An aluminum capacitor may have an operating voltage of about 450V. Other capacitor materials, such as wet or dry electrolytic titanium, may also be used if they meet the general design conditions described herein.

[0125] In this wearable defibrillator, one or more capacitors may be used. The size and number of capacitors may vary based on the electrical requirements of the pulses to be delivered. Depending on the embodiment, about 4 to about 20 capacitors may be used. Depending on the embodiment, 6 or more capacitors are used. Depending on the embodiment, about 12 to about 18 capacitors are used. Depending on the embodiment, about 15 to about 18 capacitors are used. Depending on the embodiment, 6 or fewer capacitors may be used. Depending on the embodiment, 5 or fewer capacitors may be used. Depending on the embodiment, 4 or fewer capacitors may be used.

[0126] Depending on the embodiment, the capacitor may have a density of about 3.0 g / cm 3 or less. Depending on the embodiment, the capacitor may have a density of about 2.5 g / cm 3 or less. Depending on the embodiment, the capacitor may have a density of about 2.0 g / cm 3 or less. Depending on the embodiment, the capacitor may have a density of about 1.5 g / cm 3 or less. Depending on the embodiment, the capacitor may have a density of about 1.0 g / cm 3 or less. Depending on the embodiment, a higher density capacitor with a density exceeding about 3.0 g / cm 3 may be used. Depending on the embodiment, the capacitor may have a density of about 3.0 g / cm 3 to about 10.0 g / cm 3

[0127] ​Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 20 cm 3 and less. Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 16 cm 3 and less. Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 15 cm 3 and less. Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 12 cm 3 and less. Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 10 cm 3 and less. Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 7.5 cm 3 and less. Depending on the embodiment, the volume occupied by the plurality of capacitors is less than about 5 cm 3 and less.

[0128] Depending on the embodiment, the total rated capacitance of the plurality of capacitors may exceed about 25 microfarads (μF). Depending on the embodiment, the total rated capacitance of the plurality of capacitors may exceed about 50 microfarads (μF). Depending on the embodiment, the total rated capacitance of the plurality of capacitors may exceed about 100 microfarads (μF). Depending on the embodiment, the total rated capacitance of the plurality of capacitors may exceed about 125 microfarads (μF). Depending on the embodiment, the total rated capacitance of the plurality of capacitors may exceed about 150 microfarads (μF). Depending on the embodiment, the total rated capacitance of one or more capacitors may exceed about 400 μF.

[0129] Depending on the embodiment, the capacitor may have a discharge time constant of less than about 3 milliseconds.

[0130] The plurality of capacitors may have a weight of less than about 500 grams. Depending on the embodiment, the plurality of capacitors may have a weight of less than about 200 grams. Depending on the embodiment, the weight of the plurality of capacitors is from about 100 grams to about 200 grams. Depending on the embodiment, the weight of the plurality of capacitors is from about 125 grams to about 175 grams.

[0131] The capacitor may have various shapes. For example, the capacitor may be in the shape of a pencil or cylinder, the shape of a coin cell, the shape of a Lazarnya, or a spiral or circular shape. The configuration of the capacitor may be selected to minimize the overall volume occupied by the capacitor in order to enhance the mountability of the defibrillator.

[0132] In some embodiments, one dimension of the capacitor shape may be minimized to be less than a set depth. In some embodiments, one dimension of the capacitor may be suppressed to about 20 mm or less. In some embodiments, one dimension of the capacitor may be suppressed to about 15 mm or less. In some embodiments, one dimension of the capacitor may be suppressed to about 10 mm or less.

[0133] To meet the design requirements of the capacitor, a plurality of capacitors may be used. The capacitors may be arranged in parallel, in series, or in a combination of parallel and series. In some embodiments, the capacitors are selected and arranged to achieve a total operating voltage of about 1800 V and a total rated capacitance of about 100 μF. FIG. 27 shows various capacitor configurations 2702, 2704, 2708 that can be used to achieve a total operating voltage of about 1800 V and a total rated capacitance of about 100 μF. In one example, by arranging two capacitors, each having an operating voltage of 900 V and a rated capacitance of 200 μF, in series, it is possible to achieve a capacitance of 100 μF and a voltage of 1800 V. In another example, by arranging two capacitors, each having an operating voltage of 1800 V and a rated capacitance of 50 μF, in parallel, it is possible to achieve a capacitance of 100 μF and a voltage of 1800 V. In another example, by arranging two capacitors, each having an operating voltage of 450 V and a rated capacitance of 400 μF, in series, it is possible to achieve a capacitance of 100 μF and a voltage of 1800 V. In another example, by arranging four capacitors, each having an operating voltage of 900 V and a rated capacitance of 100 μF, in a 2×2 parallel configuration, it is possible to achieve a capacitance of 100 μF and a voltage of 1800 V.

[0134] Depending on the arrangement and configuration of multiple capacitors, it is possible for one capacitor to discharge while several other capacitors are charged simultaneously.

[0135] In some embodiments, multiple capacitors with different electrical characteristics may be used in combination. Each capacitor may have a unique identifier that includes the individual information of the specific capacitor. The unique identifier can be recognized by electronic components and can be considered by software during the operation of this wearable defibrillator. In one example, the unique identifier of the capacitor can perform a digital handshake with the electronic components and software so that the operating conditions can be adjusted to the specific capacitor used in this device.

[0136] In some embodiments, the capacitors may be removed from a used wearable defibrillator and reused in a new or repaired device. An inspection protocol may be used to confirm that those capacitors still meet the design specifications. A repair protocol may also be used to inspect and replace parts of the device that are considered to be more likely to fail.

[0137] In some embodiments, there may also be a design that delivers a defibrillation pulse without using a capacitor. For example, in some cases, a parallel power converter or an interlocked power converter, a solid-state battery, or a compensating resistor may be used.

[0138] This wearable defibrillator can deliver energy to a patient using any conventional waveform. In one embodiment, a truncated biphasic waveform is used. In some cases, the waveform may be modulated. In some embodiments, the waveform may be finely adjusted to improve efficiency. For example, by truncating the waveform, it is possible to reduce the negative tail voltage.

[0139] The amount of energy delivered during a defibrillation pulse can be determined in advance and monitored. In some embodiments, about 50 joules to about 200 joules are delivered during a defibrillation pulse. In some embodiments, about 75 joules to about 150 joules are delivered during a defibrillation pulse. In some embodiments, about 100 joules to about 200 joules are delivered during a defibrillation pulse. In some embodiments, about 130 joules to about 150 joules are delivered during a defibrillation pulse. In some embodiments, a pulse of about 150 joules may be delivered. In one example, a pulse of about 130 joules may be delivered, which is expected to achieve 99% effectiveness. In another embodiment, the defibrillator may deliver up to 200 joules. In another embodiment where a non-biphasic pulse is used, up to 360 joules may be delivered. The amount of energy required may depend on the size or weight of the patient, and generally, larger individuals require higher energy requirements.

[0140] The wearable defibrillator may include an impedance circuit that measures the transthoracic impedance of the electrodes before and during delivery of a defibrillation pulse. This circuit can measure an analog value or a threshold value. Since the wearable defibrillator adheres to the body, it is possible to perform real-time measurement of transthoracic voltage with high accuracy compared to competing products. The transthoracic impedance may vary depending on the position of the electrodes and the defibrillator. The transthoracic impedance of the patient may not need to be measured until the wearable defibrillator is installed on the patient. The transthoracic impedance measured during a defibrillation pulse may be used to adapt the waveform to deliver a set amount of energy during the defibrillation pulse. The defibrillation waveform and impedance measurement may be as disclosed in U.S. Patent No. 5,607,454 or U.S. Patent No. 5,735,879.

[0141] Various patient vital signs and data can be measured by the wearable defibrillator described herein. The ECG sensing electrodes of the upper patch and the lower patch can measure the patient's ECG data. The ECG sensing electrodes and the defibrillation pad electrodes of this wearable defibrillator can adhere to the patient's body. The water vapor transmission rate to the skin surface portion of the patient, which can be achieved by the ECG sensing electrodes, the defibrillation pad electrodes, and the adhesive material that adheres to the patient's skin, is more than 250 g / m 2 per day. In some embodiments, the ECG sensing electrodes, the defibrillation pad electrodes, and the adhesive material can achieve any of the water vapor transmission rates described herein with respect to the skin with which the ECG sensing electrodes, the defibrillation pad electrodes, and the adhesive material come into contact.

[0142] In addition to the ECG data, data can be collected from any of the sensors disclosed herein, including sensors integrated with the wearable defibrillator and sensors separate from the wearable defibrillator. For example, a microphone may be used to listen to heart sounds (e.g., heartbeats), the patient's breathing, or voice commands. Various parameters and data may be extracted from the ECG sensing electrodes and other sensors. For example, data corresponding to the patient's heart rate, heart rate variability, pulse, heart sound, respiratory rate, breath sound, voice command, etc. may be collected.

[0143] Analysis of patient data may be performed to determine whether the patient may think treatment is necessary or whether the device may need adjustment or replacement. Analysis of patient data may be performed to determine the patient's cardiopulmonary status, check whether the patient has a pulse, check the heart rhythm for ventricular fibrillation, and determine whether the patient is conscious. It is also possible to query the status of the device and the electrodes using the patient data. Analysis of the impedance of the electrodes may be performed to confirm that the electrodes are properly engaged with the patient's skin. By querying the status of the wearable defibrillator using the patient data, it is also possible to check for device errors.

[0144] Based on the analysis results of patient data, this device can perform several different actions or provide notifications to the patient. By analyzing the ECG data, it is possible to determine whether the patient has a treatable arrhythmia. If the patient is determined to have a treatable arrhythmia, this wearable defibrillator may deliver a therapeutic shock to the patient. Before delivering an electrical shock, this wearable defibrillator may provide an auditory or tactile warning to the patient. This wearable defibrillator may also confirm the absence of a heartbeat or pulse before delivering an electrical shock to the patient. In some embodiments, before delivering an electrical shock, the transthoracic impedance of the patient may be measured between a first defibrillation pad electrode and a second defibrillation pad electrode. This impedance measurement may be performed to confirm proper electrical contact and to adjust the characteristics of the waveform based on the transthoracic impedance to deliver a desired amount of electrical energy to the patient.

[0145] By combining various parameters for data analysis, higher sensitivity and specificity can be achieved than possible with any individual parameter alone. By combining data from various sensors, it is possible to remove interference by performing redundant measurements. By measuring and analyzing physiological parameters, it is possible to enhance clinical validity by enabling the validation of intermediate values such as heart rate. Measuring physiological parameters provides an advantage over "blind" algorithms such as deep learning networks that do not analyze physiological parameters.

[0146] In some embodiments, VF / VT detection may be performed by using the ECG as the primary input to achieve sensitivity and determining specificity by auscultation of heart sounds. There are no heart sounds during cardiac arrest. By combining ECG sensor analysis and listening for heartbeats, it is possible to maximize sensitivity and specificity for detection and treatment.

[0147] Determining the heart rate using ECG data may sometimes indicate conflicting information about the patient's condition. For example, there may be a case where the ECG data shows VF while the microphone picks up heart sounds, which may indicate the need to repair this device, replace this device, adjust the electrode placement or adhesion, or overall review the adhesion of this device to the body. Furthermore, by simultaneously performing acoustic sensing and electrical sensing on the heart, signs of other heart lesions (e.g., MI, worsening CHF, pulmonary edema) that could not be detected with sufficient accuracy by just one sensor may be detected.

[0148] Data from various sensors can also provide additional information about the state of this wearable defibrillator. For example, it is possible to estimate the battery state, memory state, device performance history, and treatment readiness status from a combination of multiple sensors worn. The sensors do not have to be worn together with this wearable defibrillator or integrated with this wearable defibrillator. These additional sensors may be worn on peripheral devices and the data is sent to the algorithm processing unit. These sensors may also be used to trigger in-device events, which may include determining that the patient has fallen or the presence of a magnetic field. The sensors do not have to directly correspond to physiological characteristics observable by humans. For example, if it is an acoustic sensor, it is possible to measure sounds in the ultrasonic band. Auxiliary data may be used to identify additional information about the patient (e.g., posture). In some cases, auxiliary data may be used to determine whether a treatment delay is considered appropriate based on the time of day or the patient's posture.

[0149] Analysis of sensor data may be performed to check for potential problems related to the adhesion of this wearable defibrillator and electrodes to a patient. If any potential problems are detected by the sensor data, a notification message or alert may be provided to the patient and / or healthcare provider. This message or alert may provide the user or healthcare provider with instructions to adjust the ECG electrodes, instructions to adjust other device functions, or instructions to replace the device.

[0150] Figure 34 is a schematic diagram of a portion 3400 of a wearable defibrillator according to some embodiments. Data from a plurality of ECG electrodes (ECG0, ECG1, ECG2, ECG3) may be processed by analog and digital signal conditioning. The conditioned ECG signals may be analyzed to perform QRS detection and heart rate detection, and then arrhythmia detection may be performed. The ECG signals and arrhythmia detection results may be transmitted to the command and control module of the device. Signals from auxiliary sensors such as accelerometers, capacitive touches, and any other sensors described herein may be conditioned and analyzed by the signals transmitted to the command and control module. The command and control module of the device is capable of making a diagnosis for the device and the collected data. The command and control module is also capable of recording heart event records and other data collected by sensors interfacing with the command and control module. In some cases, the command and control module may store all of the raw data collected by the wearable defibrillator. These raw data may be downloaded or transmitted to a healthcare provider for analysis.

[0151] The user interface of the device may include a patient feedback module and a communication protocol module (e.g., a wireless data transmission module). The patient feedback module may output the display of the patient's health status and the operating status of the device with one or more LEDs. Further patient feedback may be provided by one or more of a tone alarm, a voice alarm, and a vibration alarm. The device may be powered on by the patient using a button that interacts with the patient feedback module.

[0152] The command and control module may also send commands to the high-voltage section of the device. If a treatable arrhythmia is detected, the command and control module may send an instruction to charge a capacitor by the battery of the device to the high-voltage section of the device. After the capacitor is properly charged, the command and control module may instruct the device to apply an electric shock to the defibrillation pad electrodes.

[0153] FIG. 35 is a schematic diagram of a portion 3500 of a wearable defibrillator according to some embodiments. The wearable defibrillator includes an impedance measurement module as part of a low-voltage system. The controller may include a command and control module, an algorithm module, a configuration module, a diagnostic module, an inspection module, and an extraction module. The algorithm module may include a QRS sensing module, an arrhythmia detection module, an artifact avoidance module, and a shock / no shock decision module. The illustrated schematic also includes a treatment system, and the treatment system has a control module, a safety module, a charging module, and an electrical energy delivery module.

[0154] The wearable defibrillator may include a circuit having components that implement any of the functions described herein. In some embodiments, the wearable defibrillator includes one or more discrete circuits that implement the functions described herein. In some embodiments, the wearable defibrillator may include an application-specific integrated circuit (ASIC).

[0155] Figures 36 and 37 show additional examples of control blocks 3600, 3700 and circuit designs that can be used in the wearable defibrillator disclosed in this specification. In some embodiments, the wearable defibrillator may be composed of six basic components, namely, a low-voltage block, a high-voltage block, a battery block, and defibrillation pads (leading electrode, trailing electrode, and sensing electrode).

[0156] The low-voltage block may be responsible for the command and control of the device, user interface, low-voltage power distribution, ECG signal conditioning, R-wave sensing, arrhythmia detection, diagnosis, communication, etc. Analog signal conditioning may include signal amplification and filtering. Digital signal conditioning may include linear filtering, pacing, spikes, and removal.

[0157] As shown in FIG. 36, the low-voltage block may include one or more of a command and control block (3602), a user interface block (3604), a low-voltage power distribution block (3606), an analog signal conditioning block (3608), a digital signal conditioning block (3610), a sensing block (3612), a detection block (3614), an event record block (3616), a communication block (3618), a diagnostic block (3620), a patient protection block (3622), and an auxiliary block (3624).

[0158] Command and control (3602) may include the logical center of the device, which is responsible for the high-level control of the device. From the non-powered state, when the button is pressed, the command and control block is activated. The device has one button that operates as a power-on and patient feedback input, i.e., an activation / patient feedback button, and a microcontroller. Upon the first button press, a switch between the voltage regulator and the battery may be closed. When the switch is closed, sufficient power is provided to the command and control block for the initialization procedure of the power supply to the command and control block and for shift control. Once this is done, the function of the button switches to patient feedback. When the power of the device is turned on, the device may remain in a low-power state with the lead detected. In some embodiments, the device may have an off button.

[0159] The event record can store all events (event records, diagnoses) that may be categorized as critical events detected by the device. Critical events may cover the results of self-test processing upon power-on, calibration during manufacturing, diagnosis during wear, diagnosis during storage, irregular events, etc. The categories of these events may be listed as i) cardiac events, ii) post-event events, and iii) diagnoses. The event record may be stored in an external NAND flash of the microcontroller.

[0160] Therefore, the command and control block can control activation, initialization, event records, diagnosis, user experience, high-voltage commands, artifact avoidance, and communication protocols.

[0161] The activation function and the diagnostic function may include checking the device to confirm that the battery is properly charged and that all subsystems are functioning as expected. This may be done each time a button is pressed when the device is away from the patient. The test may be initiated in the same manner as when the device is worn by the patient. When the button is pressed while the device is away from the body and in a low power state, the device generates an interrupt to wake up the microcontroller and thereby perform a diagnostic test (see the circuit design of FIG. 44). This diagnostic test has a non-responsive period to limit the risk of excessive current consumption due to over-pressing of the button.

[0162] In some embodiments, an independent test device may be used in consideration of the agitation that may occur if the AED fails (e.g., if the device is not ready when needed). The independent test device can be used to test the device and provide inexpensive proof that the device is operating properly and can deliver a defibrillation shock when needed. In some cases, by incorporating the independent test device into the package enclosure, it becomes possible to reasonably evaluate the state of the device and query the device for information regarding its operating state. A patient or healthcare professional can use the independent test device immediately before attaching the device to the patient to confirm its integrity.

[0163] When activated and power control is transferred from the user / button to the microcontroller, initialization occurs. At this stage, the microcontroller becomes capable of performing all procedures necessary to start monitoring the patient.

[0164] In some cases, a capacitive touch sensor may be used to provide another way (e.g., other than impedance) to detect whether the patient / electrode interface is proper. If it is a capacitive touch, it can be mounted on the electrode itself so as not to affect sensing.

[0165] In event records and diagnostics, an internal flash memory may be used to store boot records, post results, resets, and diagnostic information. Heart events may be stored in external memory as shown in FIG. 37. The user interface may include inputs such as patient feedback buttons and capacitive touch sensors. Outputs may include status indicators of the operating state of the device and other device information.

[0166] The high voltage control system may provide a high level interface to the high voltage module. The microcontroller must be able to command the execution of functions such as on / off, enable / arm, charge, disarm, shock, status, and self-check for the high voltage module at a minimum.

[0167] Artifact avoidance may be implemented by software-based ECG analysis and by utilizing external auxiliary sensors such as data from accelerometers, capacitive touch sensors, thermometers, remote pulse measurements, and other sensors disclosed herein.

[0168] This wearable defibrillator may include a communication protocol capable of communicating with wireless external sensors and a method of providing real-time feedback in response to requests from remote healthcare providers.

[0169] FIG. 38 shows a block diagram 3800 of a wearable defibrillator system. In the figure, there is a high voltage isolation 3802 between a low voltage section 3803 and a high voltage section 3804. The low voltage section 3803 includes a sensing electrode 3806, an analog front end 3808, a user interface 3810, a microcontroller 3812, an auxiliary sensor 3814, a battery bank 3816, an EKG low signal 3818, an EKG preprocessed signal 3820, and a low voltage control signal 3822. The high voltage section 3804 includes a capacitor bank 3824, a charger module 3826, a therapy delivery module 3828, defibrillation pads 3830, and a high voltage control signal 3832.

[0170] There are some safety concerns regarding placing a high-voltage capacitor, specifically an electrolytic capacitor, near the body within a wearable device. This wearable defibrillator may include a fault mitigation protocol to avoid unsafe situations caused by certain types of device failures, specifically failures related to the electrolytic capacitor. FIG. 39 shows a block diagram 3900 indicating several fault modes and what could potentially be the causes of those faults. The software of this wearable defibrillator can detect and analyze any of the fault situations shown in FIG. 39 by analyzing the operating situation. In order to avoid situations or environments that are not safe for the patient wearing the defibrillator, faults can be identified and appropriate actions can be taken. Alerts regarding the type of device failure and proposed actions may be given to the user as appropriate.

[0171] This wearable defibrillator includes software that implements any of the functions described in this specification. The software can analyze ECG monitoring data, identify arrhythmia conditions that can be treated by defibrillation pulses when they occur, measure transthoracic impedance, and deliver therapeutic defibrillation pulses.

[0172] The software may include a learning mode to learn the patient's unique ECG pattern. The software can determine whether the electrical contact of the electrodes is good by analyzing data from the impedance sensor. Excessive impedance may also be detected, which may be due to electrode dehydration, dry skin, skin irritation, skin degradation, etc.

[0173] The software can adapt the treatment based on any of the sensors disclosed in this specification. For example, the treatment may be different when the patient is sleeping or when there is humidity such as when the patient is in the shower. The software can analyze any of the fault situations shown in FIG. 39 and identify the potential causes of the faults.

[0174] This wearable defibrillator is worn under the patient's clothing. It may be convenient for this wearable defibrillator to communicate data wirelessly with other devices. Data related to the device's status, usage history, warnings, etc. may be transmitted. Examples of data communication methods that can be used with and incorporated into this wearable defibrillator include, for example, Bluetooth (registered trademark), Wi-Fi, mobile phone, wireless, or any other suitable data modem communication method. This wearable defibrillator may be configured to communicate wirelessly with a smartphone or tablet computer.

[0175] This wearable defibrillator may be queried wirelessly for its status. Programs have been developed to query the status of an ICD, S-ICD, or pacemaker. This wearable defibrillator may be configured to be queried for its status in order to query the status of an ICD, S-ICD, and pacemaker using equipment currently in use in a hospital. This wearable defibrillator may also be designed to be able to query its status using a smartphone, tablet, laptop, or computer at home.

[0176] In some embodiments, the software and firmware of this device may be updated by wireless data transfer.

[0177] This wearable defibrillator may communicate wirelessly with a separate wristband, wristwatch, or other wearable device from this wearable defibrillator. A wristband or wearable device separate from this defibrillator may store status data, history data, or any other useful data related to this defibrillator. The wristband may be more easily accessible for emergency medical technicians or other healthcare providers to obtain data from the defibrillator.

[0178] Data related to a cardiac event may be transmitted wirelessly. An emergency medical technician may receive data related to a cardiac event from the display of the wearable defibrillator, a wristband, wireless data transfer, or any other method of transmitting data related to a cardiac event from the wearable defibrillator.

[0179] In some embodiments, the wearable defibrillator may automatically transmit wirelessly to a mobile phone or data network location data related to a cardiac event or location data regarding whether the device is to deliver a shock. The location data may be determined by a GPS sensor on the device. The location of the defibrillator may be automatically transmitted and reported to an emergency medical network. In some cases, a request for emergency medical treatment may be automatically made by the device.

[0180] In some embodiments, a small visual display for providing information and / or instructions to the user may be provided on the defibrillator.

[0181] In some embodiments, the device does not include a visual display in order to minimize weight and form factor. The lack of a visual display on the wearable defibrillator may make visual interaction between the device and the user difficult. The device may communicate information to the user using one or more of an alarm, button, audible notification or warning (e.g., via a built-in speaker), tactile feedback, vibration, electrical shock, etc. This information may be triggered by various events (e.g., an impending shock delivery while in standby).

[0182] For example, there may be a system status button related to one or both of the electrode areas. This system status button may display a green light during normal operation and a red light when indicating the presence of a potential problem.

[0183] Depending on the embodiment, the wearable defibrillator may include a switch or button that performs override control on the capacitor bank, the battery module, or any other part of the device. These switches may take various forms, such as pinch sensors, pressure - required buttons, or capacitive sensors.

[0184] Depending on the embodiment, the device may vibrate in an attempt to wake up the patient before delivering the defibrillation pulse. This is because if the patient is asleep or unconscious, another treatment may be required. By attempting to wake up the patient, it is possible to reduce the false - positive rate. Another option for waking up the patient is to deliver a small shock or a transcutaneous ping before delivering the defibrillation pulse. Depending on the embodiment, the device may include a dead - man switch.

[0185] Additional information may be displayed to the user by a wristband, a smartphone, a tablet, or other devices having a display as disclosed herein.

[0186] The wearable defibrillator may include additional sensors, functions, and additional wearable devices. Depending on the embodiment, the wearable defibrillator includes additional sensors, such as accelerometers, microphones, gyroscopes, GPS location determination, temperature sensors, and any other discrete sensors.

[0187] Depending on the embodiment, the wearable defibrillator may include a sensing circuit that measures the operating state of the device and the quality of the electrode adhesion to the body by monitoring the electrode contact. The electrodes may have capacitive sensors to measure whether the electrodes are flipped or have lost contact with the patient. The capacitive sensors can measure impedance with low power consumption to determine whether the electrodes are in good contact with the skin or peeled off. If the electrodes are peeled off, the user may be notified to press the electrodes back.

[0188] As additional wearable devices, for example, there are wearable bracelets, wristwatches, or other similar devices. The bracelet may include a hemodynamic sensor that examines the patient's pulse. This pulse data can be useful when the bracelet is able to continue measuring the pulse even if contact with the chest device is lost. The bracelet may have an override switch. The bracelet may include a display and a touch screen. The bracelet may also store data and transfer information. Information that can be provided by the bracelet includes system status, battery status, warnings, notifications, user application buttons, etc. A visual indicator that notifies the user that there is a problem that must be corrected may be on the bracelet, wristwatch, or device. Examples of the bracelet and its functions are shown in FIGS. 79 and 80.

[0189] A spouse may wear the bracelet to receive notifications regarding the status of this wearable defibrillator and the patient's health status. Regarding the wristwatch, a wristwatch having any of the functions described in this specification may be used.

[0190] FIG. 40 shows a typical series of events for a patient prescribed a wearable defibrillator. The patient may be suffering from heart disease (4002) and undergoes a doctor's examination (4004). The doctor may first attach this wearable defibrillator to the patient (4006). Thereafter, the patient may normally carry out normal life activities, for example, exercise (4008), take a shower (4010), sleep (4012), etc. After the initial wearing period ends, the user receives replacement parts such as new adhesive pads (4014). Thereafter, the user attaches the device using the new adhesive pad (4014) and carries out normal activities (4016). When the treatment period by this wearable defibrillator ends, the user may return or send back the device (4018). A medical professional may download and analyze the data acquired and accumulated by this wearable defibrillator (4020), and the results may be used for subsequent treatment and diagnosis (4022).

[0191] The overall shape of the device may be designed to improve the user's comfort by considering how the device contacts the skin and hangs from the body. The device may be designed to enhance ergonomic usability and suppress skin irritation. To further improve the user's comfort, the weight may be evenly distributed throughout the overall shape of the device. The device shape may also be designed to provide additional support for the heavier parts of the device with a part of the body, such as wearing the device over the shoulder. Embodiments of various device shapes are shown in FIGS. 45 to 74.

[0192] The heavy components in this defibrillator device are the capacitor and battery components. For example, the total weight of the capacitor may be about 100 to 200 grams, but it may weigh up to 500 grams. In one example, the weight of the capacitor is about 160 grams. The weight of the battery component may be about 50 to 100 grams. The overall shape of the device (e.g., the surface area in contact with the skin) may be designed such that the weight is distributed throughout the body. The weight distribution and device shape may be based on the desired wearing period and device weight. In some embodiments, the value obtained by dividing the total weight of the device by the surface area is about 0.5 g / cm 2 Hereinafter, about 1.0 g / cm 2 Hereinafter, about 1.1 g / cm 2 Hereinafter, about 1.2 g / cm 2 Hereinafter, about 1.3 g / cm 2 Hereinafter, about 1.4 g / cm 2 Hereinafter, about 1.5 g / cm 2 Hereinafter, about 1.6 g / cm 2 Hereinafter, about 1.7 g / cm 2 Hereinafter, about 1.8 g / cm 2 Hereinafter, or about 1.9 g / cm 2 Hereinafter. In some embodiments, the value obtained by dividing the total weight of the device by the surface area is about 2 g / cm 2 Hereinafter, about 2.3 g / cm 2 Hereinafter, about 3 g / cm 2 Hereinafter, or about 5 g / cm 2 Hereinafter.

[0193] The device may hold the capacitor and the battery in separate sections to distribute heavy components. The device may be flexible to accommodate body curvature and provide additional degrees of freedom. For example, a flexible hinge, living hinge, bridge, flexible interconnect, or articulation point may be used between heavy rigid components such as the battery and capacitor. In some embodiments, the battery, capacitor, and other heavy components may be enclosed in a housing separate from the patient engagement substrate. This separate housing may be supported by an adhesive fixture to the body, clipped to clothing, or supported away from the body's biological structure.

[0194] In some embodiments, the patient engagement substrate of the device includes a layered structure that can be used to transition from the elastic modulus of the skin, for example, to the rigid components within the housing. These layers may transition from being elastic near the skin to increasing in rigidity and decreasing in elasticity towards the rigid components, as shown in FIG. 81B.

[0195] In some embodiments, the outer shape of the device may be designed to use a common point of the biological structure as a location to fix to the body. For example, the device may be designed to be attached to the sternum. This is because the sternum has less variation between patients than other parts of the biological structure.

[0196] In some embodiments, the device may include a sling band having a shoulder or neck support, thereby providing additional support for the weight of the device on the shoulder and / or neck, as shown in FIGS. 47, 48, 56, 59, and 77.

[0197] The defibrillator device may also be designed such that the edges are tapered so that the edges do not catch on clothing or other objects.

[0198] Depending on the embodiment, the outer shape of the present device may be designed so that the device can be rotated to attach the adhesive material and the electrodes to a plurality of different locations on the skin. By supporting the device in a plurality of different regions of the skin, the wearing comfort of the device is improved and the long-term wearability is enhanced. For example, as shown in FIG. 87, a triangular or petal-shaped device outer shape design may be adopted.

[0199] Depending on the embodiment, in order to enable the skin that has previously come into contact with the adhesive material to recover, different form designs may be used around the electrodes when switching the unit.

[0200] Depending on the embodiment, the electronic circuit, capacitor, and battery may be divided into a plurality of parts or sections.

[0201] Depending on the embodiment, various device outer shapes may be used according to the treatment plan for the patient and the patient's characteristics.

[0202] Depending on the embodiment, electrical components with a shorter duration than the wearing period may be replaced. For example, an old battery may be replaced with a new battery.

[0203] Depending on the embodiment, the present device may include an adjustable section according to the mounting location in order to minimize the number of deformable forms of the device outer shape.

[0204] Depending on the embodiment, for use with the form factor of the present device, one or more of the capacitor bank, electronic circuit board, and battery may be selected based on the specific characteristics of the patient and the treatment. For example, the capacitor may be selected based on the patient's size or thoracic impedance. In the case of a patient with a pacemaker, a different type of electronic circuit board may be used so that the sampling rate of the present device can be increased. For a specific electronic circuit board, different batteries may be used in pairs.

[0205] Depending on the embodiment, the capacitor and the electrical contacts are reusable. In some cases, the capacitor and the electrical contacts may be repaired before being reused in another device.

[0206] Figures 41 and 42 show various component arrangements in an embodiment of a wearable defibrillator. Figure 41 shows the component arrangements of capacitor 4102 and battery 4104 in various configurations 4100, 4106, 4108, 4100, 4112, 4114, 4116, 4118, 41120, 4122, 4124, 4126, 4128, 4130, 4132, 4134, 4136, 4138, 4140, 4142, and 4144. Capacitor 4104 may be arranged within a high-voltage module. Capacitor 4104 may be in a flat shape and arranged such that its weight is distributed across the entire surface of the wearable defibrillator. Figure 42 shows further arrangements (4200, 4210, 4212, 4214, 4216, 4218, 4220, 4222, 4224, 4226, 4228, and 4230) of capacitor 4202 and battery 4204 in the first section 4206 and the second section 4208 of the wearable defibrillator. The capacitor may be arranged in one module of the wearable defibrillator, and the battery and low-power / low-voltage components may be arranged in another second module or section of the wearable defibrillator.

[0207] Figure 43 shows the component arrangement in an embodiment 4300 of a wearable defibrillator. Battery 4302 is arranged in the first module or section 4304 of the wearable defibrillator, which may be referred to as a low-voltage module. Capacitor 4306 is arranged in another second module or section 4308 of the wearable defibrillator, which may be referred to as a high-voltage module. The defibrillation electrodes are in electrical communication with the high-voltage module. The low-voltage module can monitor the patient's heart rate through a sensor and control the energy transfer when a shock administration is required. The battery charges the capacitor within the high-voltage module, and the capacitor then sends the electrical energy for delivering electrical therapy to the patient to the defibrillation pad electrodes.

[0208] Figure 44 shows various component arrangements in an embodiment of a wearable defibrillator. Figure 44 shows an embodiment 4400 of a wearable defibrillator, which includes a high-voltage module 4402 having a capacitor 4404 and a low-voltage module 4406 having a battery 4408. The high-voltage module 4402 and the capacitor 4404 are configured to deliver electrotherapy via defibrillation electrodes 4410, 4412. Figure 44 shows various arrangements (4414, 4416, 4418, 4420, 4422, 4424, 4426, 4428, 4430, 4432, 4434, 4436, and 4438) of the high-voltage module 4402 and the capacitor 4404, and the low-voltage module 4406 and the battery 4408. The capacitor is configured to have a circular and semi-circular cross-sectional shape. The capacitor extends across the entire high-voltage module, and the battery is arranged in the low-voltage module. The wearing period may be determined by balancing the weight of the device and the area adhered to the body. Figure 60 shows data on the relationship between the wearing period and the adhesive load for various adhesive types and weights.

[0209] Figures 45 through 48 show various outer shapes and configurations of a wearable defibrillator, with electrodes on the patient's upper chest and an electronic circuit / battery and capacitor in a separate pocket attached under the patient's arm at the side. The wearable defibrillator 4500 shown in Figure 45 includes an upper patch 4502 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 4504 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 4504 supports a first electronic circuit module 4506 and a second electronic circuit module 4508. The wearable defibrillator 4600 shown in Figure 46 includes an upper patch 4602 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 4604 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 4604 supports a first electronic circuit module 4606 and a second electronic circuit module 4608. The wearable defibrillator 4700 shown in Figure 47 includes an upper patch 4702 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 4704 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 4704 supports a first electronic circuit module 4706 and a second electronic circuit module 4708. The wearable defibrillator 4700 has a shoulder-mounted configuration. The wearable defibrillator 4800 shown in Figure 48 includes an upper patch 4802 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 4804 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 4804 supports a first electronic circuit module 4806 and a second electronic circuit module 4508. The wearable defibrillator 4800 has a shoulder-mounted configuration.

[0210] Figure 49 is a diagram depicting a weight model of a wearable defibrillator attached to a mannequin. The wearable defibrillator 4900 shown in Figure 49 includes an upper patch 4902 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 4904 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 4904 supports a first electronic circuit module 4906 and a second electronic circuit module 4908. The first electronic circuit module 4906 includes a battery 4910, and the second electronic circuit module 4908 includes a capacitor 4912. One defibrillation electrode is attached to the upper chest of the mannequin, and the capacitor, battery, and second defibrillation electrode are adhered to the side of the mannequin's chest. The capacitor was modeled with a weight of 160 grams, and the battery section was modeled with a weight of 100 grams. The adhesive supported a weight of 260 grams at the side of the mannequin.

[0211] Figure 50 is a diagram depicting a weight model of a wearable defibrillator attached to a mannequin, which is very similar to Figure 9, but the shapes of the modules supporting the capacitor and battery sections of this device are different. The wearable defibrillator 5000 shown in Figure 50 includes an upper patch 5002 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 5004 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 5004 supports a first electronic circuit module 5006 and a second electronic circuit module 5008. The first electronic circuit module 5006 includes a battery 5010, and the second electronic circuit module 5008 includes a capacitor 5012.

[0212] Figure 51 is a diagram depicting a weight model of a wearable defibrillator 5100 attached to a mannequin. The wearable defibrillator 5100 shown in Figure 51 includes an upper patch 5102 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, a lower patch 5104 including a patient engagement substrate having defibrillation electrodes and an ECG sensor, and a second upper patch 5105. The second upper patch 5105 supports a first electronic circuit module 5106. The lower patch 5104 supports a second electronic circuit module 5108. The first electronic circuit module 5106 includes a battery 5110, and the second electronic circuit module 5108 includes a capacitor 5112. One defibrillation electrode is attached to the upper chest of the mannequin, and a second defibrillation electrode is attached to the side of the mannequin. Models of the battery and low-voltage components are also attached to the chest of the mannequin at a weight of 50 grams. The model of the capacitor is adhered to the side of the chest of the mannequin at a weight of 160 grams.

[0213] Figure 52 is a diagram depicting a weight model of a wearable defibrillator 5200 attached to a mannequin. The wearable defibrillator 5200 shown in Figure 52 includes an upper patch 5202 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 5204 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 5204 supports a first electronic circuit module 5206 and a second electronic circuit module 5208. The first electronic circuit module 5206 includes a battery 5210, and the second electronic circuit module 5208 includes a capacitor 5212. One defibrillation electrode is attached to the upper chest of the mannequin, and the capacitor, battery, and a second defibrillator electrode are adhered to the side of the chest of the mannequin. The capacitor is modeled at a weight of 160 grams, and the battery section is modeled at a weight of 50 grams.

[0214] FIG. 53 shows two wearable defibrillators 5300 and 5320, with patches attached to the chest and electrodes, capacitors, and a battery supported under the patient's arm at the side. The wearable defibrillator 5300 shown in FIG. 53 has an upper patch 5302 including a patient-engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 5304 including a patient-engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 5304 supports a first electronic circuit module 5306 and a second electronic circuit module 5308. The wearable defibrillator 5320 shown in FIG. 53 has an upper patch 5322 including defibrillation pad electrodes and an ECG sensor, and a lower patch 5324 including defibrillation electrodes and an ECG sensor. The lower patch 5324 supports a first electronic circuit module 5326 and a second electronic circuit module 5328.

[0215] FIG. 54 shows two configurations 5400 and 5420 of a wearable defibrillator. The wearable defibrillator 5400 shown in FIG. 54 has an upper patch 5402 including a patient-engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 5404 including a patient-engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 5404 supports a first electronic circuit module 5406 and a second electronic circuit module 5408. The wearable defibrillator 5420 shown in FIG. 53 has an upper patch 5422 including defibrillation pad electrodes and an ECG sensor, and a lower patch 5424 including defibrillation electrodes and an ECG sensor. The lower patch 5424 supports a first electronic circuit module 5426 and a second electronic circuit module 5428. Each of these configurations supports a capacitor and a battery under the patient's arm at the side. The electrodes are shown to contact either side of the chest and are in electrical communication with the capacitor. The wearable defibrillator may include a shoulder support strap that contacts the shoulder or drapes over the shoulder and down the patient's back to connect to the upper patch having the capacitor and battery section.

[0216] Figure 55 shows two configurations 5500 and 5520 of a wearable defibrillator. The wearable defibrillator 5500 shown in Figure 55 includes an upper patch 5502 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 5504 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 5504 supports a first electronic circuit module 5506 and a second electronic circuit module 5508. The wearable defibrillator 5520 shown in Figure 53 includes an upper patch 5522 including a patient engagement substrate having defibrillation pad electrodes and an ECG sensor, and a lower patch 5524 including a patient engagement substrate having defibrillation electrodes and an ECG sensor. The lower patch 5524 supports a first electronic circuit module 5526 and a second electronic circuit module 5528. Each of these configurations supports a capacitor, a battery, and electrodes under the patient's arm at the side. As shown, the upper patch has a triangular shape and may be attached to the patient's sternum or upper chest.

[0217] Figures 56A through 56H show further embodiments of a wearable defibrillator. The wearable defibrillator 5600 shown in Figure 56A has an upper patch 5602 having chest electrodes, and components with a tall profile (e.g., a capacitor and a battery) are arranged on a lower patch 5604 under the patient's arm at the side.

[0218] The wearable defibrillator 5610 shown in Figure 56B has a shoulder support. The shoulder support enables additional support of the weight of the device on the shoulder. The defibrillator electrodes may be on an upper patch 5612 and a lower patch 5614. The battery and the electronic circuit may be in a front pocket of the upper patch 5612, and the capacitor and the electrodes are shown to be in a rear pocket 5616 of the device. All other components with a tall profile may be supported at the user's side.

[0219] The wearable defibrillator 5620 shown in FIG. 56C has an upper patch 5622 with a chest electrode, and a lower patch 5624 under the patient's arm at the side has components with a high-profile shape (e.g., capacitors and batteries) disposed therein. The wearable defibrillator 5630 shown in FIG. 56D has a support 5632 around the patient's neck. The neck-mounted support 5632 may be used to support the weight of the electronic circuit components on the patient's back 5634 and the weight of the electrode components on the patient's front 5636. Other components may be supported at the patient's side 5638.

[0220] The wearable defibrillator 5640 shown in FIG. 56E can support the electrodes 5642 on the back and support the electrodes, capacitors, and batteries in the front chest pockets 5644, 5646 by being worn around the neck. The wearable defibrillator 5650 shown in FIG. 56F has a front chest pocket 5652 that supports one of the electrodes and a capacitor / battery, and a second pocket 5654 on the back that supports the other of the electrodes and the capacitor / battery. The wearable defibrillator 5660 shown in FIG. 56G has one of two chest pockets 5662, 5664 support an electrode and the other support one of the capacitors / batteries, and accordingly, a side pocket 5666 supports the other of the capacitors / batteries. The defibrillator of FIG. 56G also has an optional chest strap 5668 for additional support of the device. The setup shown in FIG. 56H is very similar to FIG. 56G but without the chest strap. The wearable defibrillator 5670 shown in FIG. 56H has one of two chest pockets 5672, 5674 support an electrode and the other support one of the capacitors / batteries, and accordingly, a side pocket 5676 supports the other of the capacitors / batteries.

[0221] Figure 57 shows a wearable defibrillator system including a wearable defibrillator 5700 and a wristband 5702. In this wearable defibrillator, the connected capacitor bank 5704 and the electronic circuit / battery compartment 5706 are supported by an adhesive pocket 5708 at the patient's side. A second electrode 5710 is supported by the adhesive pocket 5708 at the side. A chest pocket 5712 supports the first electrode 5714. The adhesive pocket is replaceable. The wristband 5702 communicates wirelessly with the wearable defibrillator 5700.

[0222] Figure 58 shows a wearable defibrillator 5800, which includes a replaceable adhesive electrode assembly 5802. The adhesive electrode assembly 5802 includes a pocket 5804 that supports a capacitor 5806, an electronic circuit, and a battery 5808. The electrode assembly includes a plug 5810 for connecting the capacitor 5806 to the electrode. After a set period, for example, 10 to 14 days have elapsed, the adhesive electrode assembly 5802 is replaced with a capacitor, an electronic circuit, and a battery unit installed in a new adhesive electrode assembly.

[0223] Figure 59 shows a wearable defibrillator system 5900, which includes connected defibrillation pads 5902, 5904, a capacitor 5906, and battery / electronic circuit components 5908. This system also includes adhesive patches and pockets 5910, 5912, 5914 configured to support the defibrillation pads, the capacitor, and the battery / electronic circuit components. The adhesive patches and pockets are replaceable.

[0224] Figure 60 shows a wearable defibrillator 6000, which has a flexible hinge 6002 between a capacitor 6006 and electronic circuit / battery components 6004. The flexible hinge 6002 can improve the comfort of wearing this device and reduce the restrictions on wearing. Each component of the capacitor 6006 and the electronic circuit / battery 6004 may be housed in an adhesive pocket 6008 including an electrode 6010.

[0225] Figure 61 shows a wearable defibrillator 6100, in which an electronic circuit and battery component 6102 are connected to a capacitor 6104 by a bridge 6106. Defibrillation pad electrodes 6108, 6110 can be respectively accommodated in adhesive pouches 61012, 6114. The electronic circuit component 6102 and the capacitor 6104 are also accommodated in a pouch 6116.

[0226] Figure 62 shows a wearable defibrillator 6200, in which a lower patch 6202 supports a capacitor module 6204 and a battery module 6206. The capacitor module 6204 includes a capacitor 6208, and the battery module 6206 includes a battery 6210. The capacitor module 6204 and the battery / electronic circuit module 6206 are accommodated in waterproof enclosures 6212, 6214 on the lower patch 6202. The footprint of this electronic circuit / battery component and capacitor component is trapezoidal. The lower patch 6202 includes a conductive material 6216 formed as a flexible pad of the lower patch 6202. The lower patch 6220 has a conductive material 6222 connected to a housing 6224, and the conductive material 6222 is separate from the flexible adhesive portion of the lower patch 6220.

[0227] Figure 63 is very similar to Figure 62, but the footprints of the electronic circuit / battery components and the capacitor components are different. The wearable defibrillator 6300 shown in Figure 63 has a lower patch 6302 that supports a capacitor module 6304 and a battery module 6306. The capacitor module 6304 includes a capacitor 6308, and the battery module 6306 includes a battery 6310. The capacitor module 6304 and the battery / electronic circuit module 6306 are housed in enclosures 6312, 6314 on the lower patch 6302. The lower patch 6302 has a conductive material 6316 connected to a housing 6318, and the conductive material 6316 is separate from the flexible adhesive portion of the lower patch 6302. The lower patch 6322 includes a conductive material 6324 formed as a flexible pad of the lower patch 6322. The lower patch 6322 includes a flexible portion 6326 between the enclosures 6312, 6314.

[0228] The wearable defibrillator shown in Figure 64 is very similar to the devices depicted in Figures 62 and 63, but there is a slit or notch 6450 between the electronic circuit / battery components and the capacitor components. The wearable defibrillator 6400 shown in Figure 64 has a lower patch 6402 that supports a capacitor module 6404 and a battery module 6406. The capacitor module 6404 includes a capacitor 6408, and the battery module 6406 includes a battery 6410. The capacitor module 6404 and the battery / electronic circuit module 6406 are housed in enclosures 6412, 6414 on the lower patch 6402. The lower patch 6402 includes a conductive material 6416 formed as a flexible pad of the lower patch 6402, and the conductive material 6416 is connected to the defibrillation pad electrode 6418 of the upper pad 6419. The lower patch 6422 has a conductive material 6424 connected to a housing 6426, and the conductive material 6424 is separate from the flexible adhesive portion of the lower patch 6422. The lower patches 6402, 6422 each include a slit 6450 between the enclosures 6412, 6414 to enhance the flexibility of the device.

[0229] Figures 65 through 70 show wearable defibrillators with various designs and configurations of the support. Figure 65 shows a unisex wearable defibrillator 6500 worn by male and female patients. The wearable defibrillator 6600 shown in Figure 66 has a side support / patch 6602 for the second electrode, capacitor 6604, and battery / electronic circuit 6606. Figure 67 shows another design of the footprints of the upper patches (6702, 6706, 6710, and 6714) and the lower patches / side supports (6704, 6708, 6712, 6716) that support the capacitor components and the battery / electronic circuit components.

[0230] Figures 68 and 69 show another embodiment of the wearable defibrillator, where the battery / electronic circuit components are supported on the upper chest of the patient. Figure 68 shows a wearable defibrillator 6800 worn by male and female patients. The wearable defibrillator 6800 includes a replaceable adhesive patch. The side support is configured to support the capacitor components. The wearable defibrillator 6900 shown in Figure 69 has a lower patch 6902 supporting a capacitor module 6904 and a defibrillation pad electrode 6906. The upper patch 6908 supports a low-voltage module 6910 and a second defibrillation pad electrode.

[0231] Figure 70 shows another footprint for the upper patches (7002, 7006, 7010, 7014) and the lower patches (7004, 7008, 7012, 7016).

[0232] Figures 71 through 74 show a wearable defibrillator having two chest pockets and a side pocket. The wearable defibrillator 710 shown in Figure 71 has a first chest pocket 7102, a second chest pocket 7104, and side electrodes 7106. The first chest pocket is configured to support defibrillation electrodes and an electronic circuit / battery. The second chest pocket is configured to support capacitor components. The second defibrillation electrode may be disposed on the patient's side. An embodiment 7200 of the wearable defibrillator shown in Figure 72 has a low voltage module 7202, a high voltage module 7204, a first defibrillation electrode 7206, a second defibrillation electrode 7208, a status indicator 7210, and a capacitive switch 7212. Embodiments 7300, 7302, and 7400 of the wearable defibrillator shown in Figures 73 and 74 are very similar to 7200 but have different outer shapes to conform to the body.

[0233] Figures 75 and 76 are views showing a patient wearing an embodiment 7500 of a wearable defibrillator from various angles.

[0234] Figures 77 and 78 show various features of an embodiment of a wearable defibrillator. The wearable defibrillator 7700 shown in Figure 77 has an upper patch 7702 that includes defibrillation pad electrodes 7704 and an ECG sensor 7706, and a lower patch 7708 that includes defibrillation electrodes 7710 and an ECG sensor 7712. The lower patch 7708 supports a first electronic circuit module 7714 and a second electronic circuit module 7716. A wristband 7720 may transmit data to the wearable defibrillator 7700. The wearable defibrillator 7800 shown in Figure 78 has an upper patch 7802 that includes defibrillation pad electrodes 7804 and an ECG sensor, and a lower patch 7808 that includes defibrillation electrodes 7810 and an ECG sensor. The lower patch 7808 supports a first electronic circuit module 7814 and a second electronic circuit module 7816.

[0235] Figures 79 and 80 show embodiments of a wearable wristband that can be used with the wearable defibrillator disclosed herein. The wristband 7900 shown in FIG. 79 can be used with any of the wearable defibrillators disclosed herein. The wristband 7900 can communicate with this wearable defibrillator. The wristband 7900 may generate an alert on the display 7902 before a shock. The display 7904 may be deactivated by touching the capacitive display. The display 7906 shows the vital signs of the patient wearing the wearable defibrillator. The wristband 8000 shown in FIG. 80 has a touch display 8002 sized for a male wearer. The wristband 8005 shown in FIG. 80 has a touch display 8007 sized for a female wearer.

[0236] FIG. 81A is a diagram showing a wearable defibrillator 8100, which has a chest pocket 8102, a sternum pocket 8104, and a flank pocket 8106 to support the components of the device.

[0237] FIG. 81B shows a cross-section 8110 of a layered-designed wearable defibrillator. The hydrophilic colloid adhesive 8112 is designed to contact the skin. The flexible substrate 8114 operates as a bridge between the adhesive and the heavy components 8116 (such as capacitors, batteries, electronic circuits, etc.). The flexible substrate can improve the comfort of wearing this device and can enhance the ability of this device to support heavy rigid components.

[0238] FIG. 82 shows a diagram of a wearable defibrillator having a shoulder support and a neck support. The shoulder support may be attached to a common point on the patient's skeleton or a biological structure on the body. The wearable defibrillator 8200 has a front chest pocket 8202 and a rear pocket 8204. The wearable defibrillator 8201 includes a neck support and a front pocket 8212 and a rear pocket similar to 8204. These pockets can support defibrillation electrodes and electronic circuit components.

[0239] Figure 83 shows the configurations of various interconnect structures for enhancing the adaptability of the present device to the body curves. The wearable defibrillator may include a rigid part 8304 and a flexible interconnect structure 8302. An adhesive layer 8310 may contact the skin 8312 and the compliant layer 8314. The compliant layer 8314 may engage with electronic circuit components 8316, 8318. The electronic circuit components 8316, 8318 may be interconnected by the flexible interconnect 8302.

[0240] Figure 84A shows a cross-sectional view and a top view of a part of the wearable defibrillation device. In one drawing, the electrode 8400 includes a channel 8402 for deploying an electrode gel or liquid for contacting the skin 8406 from a gel source 8408 between spacers 8404. The gel or liquid can improve the electrical contact between the electrode and the skin.

[0241] The device 8420 shown in Figure 84B may include an adhesive 8422, a bonding layer 8424, and an extendable anchor 8426 for supporting the defibrillator component 8428 away from the body. The extendable anchor may be used together with the bonding layer to better attach the present device to the body.

[0242] Figures 85A and 85B show a cross-sectional view and a top view of a wearable electrode including a thermally activated conductive gel deployment structure 8500 and a pressure-activated conductive gel deployment structure 8520. The thermally activated structure 8500 includes a heating element 8502, a thermally activated hydrogel 8504, an electrode 8506, a gel 8508, and a fluid via 8510. The thermally activated hydrogel 8504 may be deployed through the via 8510 to contact the skin 8512. The pressure-activated deployment structure 8520 includes a pressure source 8522, a gel 8524, and an electrode 8526, and the gel 8524 is deployed to hit the skin 8528.

[0243] Figures 86A through 86C are views showing, from various angles, a support structure for better attaching a rigid and heavy defibrillator component to a patient's body. The reinforcement structure 8600 shown in FIG. 86B may be used together with the adhesive border 8604 to further support the heavy rigid defibrillator component 8602. The structure 8610 shown in FIG. 86A has a hydrophilic colloid adhesive 8612 bonded to a PET film 8614, and a bracket 8616 is attached to the end of a rigid and heavy defibrillator component 8618. This anchor allows the heavy component to move further while achieving a strong attachment structure to the skin 8620. The device shown in FIG. 86C has a tail 8630 or a similar structure that may be used to contact the skin 8620, which applies force to the device to better engage the skin with the adhesive 8632 and the electronic circuit component 8634 and provides additional weight support for the device.

[0244] FIG. 87 shows a portion of a wearable defibrillator 8700 that has an electrode 8702 that can be rotated to improve the comfort of wearing on the skin of the wearer. FIG. 87 also shows a portion of a wearable defibrillator 8710 that has an electrode 8714 and an adhesive wing 8712. The device may be rotated so that the wing 8712 contacts a new portion of the skin. By alternately switching the portions of the skin that the adhesive contacts, it is possible to minimize skin irritation to the wearer.

[0245] The wearable defibrillator disclosed in this specification can, in some embodiments, meet various design requirements. Conventional biphasic waveforms can deliver from about 150 joules to about 360 joules to a patient. In some embodiments, therapeutic energy of 200 joules or less may be used. A voltage of 3.7 may be used to power the electronic circuit, and thus, the milliamperes per shock used will be in the range of 11.2 to 27 mAh. The charging circuit may be capable of charging a 100 μF capacitor to 1800 volts within 20 seconds. The requirements for the battery are such that a flyback transformer configuration may be used because 6 microsecond pulses of 1.3 to 1.5 occur for up to 30 seconds at a frequency of up to 10 kHz. During charging, an additional current may be required for the analysis circuit to drive the DSP power supply having a core operating at a clock around 100 MHz. This enables an additional 1 ampere load to be consumed over about 30 seconds. The shelf life can be 3 months or more. The device can hold sufficient energy at the end of the shelf life and can be worn for a desired period from there. The device may be capable of delivering 10 shocks with a single battery charge. The average load is likely to remain in the range of 5 to 10 milliamperes for most of the wear period, and rarely, a burst of a continuous current of an average of 2.5 amperes occurs for about 30 seconds. The device can obtain IEC60601 certification.

[0246] FIG. 33 is a schematic diagram of an SCD diagnostic test developed in accordance with some embodiments. The wearable defibrillator disclosed herein is capable of collecting ECG data and other patient data, and by analyzing and aggregating these data, it is possible to learn more about the patterns and causes of SCD. The ECG data can be combined with genomic data and other patient data. By combining and analyzing the ECG data, genomic data, and other data, it is possible to develop an SCD diagnostic test that can be used to predict SCD and SCD risk factors based on the health status information of an individual patient. As a result, patients can receive personalized treatment, including a wearable defibrillator, based on the results of the SCD diagnostic test.

[0247] As used herein, when a feature or element is referred to as being "on" another feature or element, that feature or element may be in direct contact with the other feature or element, or intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, no intervening features and / or elements are present. Also, of course, when a feature or element is referred to as being "connected", "attached", or "coupled" to another feature or element, that feature or element may be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached", or "directly coupled" to another feature or element, no intervening features or elements are present. Features and elements so described or illustrated are described or illustrated with respect to one embodiment, but may apply to other embodiments as well. Also, as would be understood by one of ordinary skill in the art, when a structure or feature is referred to as being "adjacent" to another feature, that reference may include the structure or feature partially overlapping the adjacent feature or having a portion underlying the adjacent feature.

[0248] The terms used in this specification are for the sole purpose of describing particular embodiments and are not intended to limit the present disclosure. For example, as used in this specification, the singular forms "a", "an", and "the" include the plural forms as well, unless the context clearly dictates otherwise. Furthermore, as a matter of course, the terms "comprises" and / or "comprising", when used in this specification, specify the presence of the stated features, steps, operations, elements, and / or components, and do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or collections thereof. In this specification, the term "and / or" encompasses any combination of one or more of the associated listed items and may be abbreviated as " / ".

[0249] Spatial relative terms such as "under", "below", "lower", "over", "upper", etc. may be used in this specification to simplify the description of the relationship between one element or feature and another element or feature as shown in the drawings. As a matter of course, this spatial relative term shall include other orientations in addition to the orientation depicted in the drawings during use or operation of the present device. For example, if the present device in the drawing is inverted, an element described as "under" or "beneath" another element or feature will be oriented "over" that other element or feature. Thus, for example, the term "under" may encompass both the "over" and "under" orientations. The present device may be rotated in other ways (rotated 90 degrees or rotated in other orientations), and the spatial relative descriptors used in this specification may be interpreted accordingly. Similarly, terms such as "upwardly", "downwardly", "vertical", "horizontal", etc. are used in this specification for illustrative purposes only, unless otherwise specified.

[0250] The terms "first" and "second" may be used in this specification to describe various features / elements, but these features / elements should not be limited by these terms, except where the context is inconsistent. These terms may be used to distinguish one feature / element from another. Thus, unless departing from the teachings of the present invention, a first feature / element may be referred to as a second feature / element when described later, and similarly, a second feature / element may be referred to as a first feature / element when described later.

[0251] As used in the examples, as used in this specification and the claims, and unless otherwise specified, any numerical value may be read as being preceded by the term "about" or "approximately", even if the term does not explicitly appear. The term "about" or "approximately" may be used to indicate that the stated value and / or position falls within a reasonable, expected range of values and / or positions when indicating size and / or position. For example, a numerical value may be a value within ±0.1% of the stated value (or range of values), a value within ±1% of the stated value (or range of values), a value within ±2% of the stated value (or range of values), a value within ±5% of the stated value (or range of values), a value within ±10% of the stated value (or range of values), or other such values. Any numerical range described in this specification is intended to include all sub-ranges subsumed therein.

[0252] Although various exemplary embodiments have been described, various changes may be made to the various embodiments without departing from the scope of the invention as recited in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various apparatus and system embodiments may or may not be included depending on the embodiment. Accordingly, the foregoing description has been provided primarily for purposes of illustration and should not be construed as limiting the scope of the invention as set forth in the claims.

[0253] The examples and figures included herein are illustrative rather than limiting, showing specific embodiments in which the subject matter of the invention may be practiced. As already described, other embodiments may be utilized and derived therefrom, and structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the subject matter of the invention may be referred to herein individually or collectively by the term "invention," which is merely for convenience and is not intended to voluntarily limit the scope of this application to any single invention or inventive concept. Accordingly, while specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any adaptations or variations of the various embodiments. It will be apparent to those skilled in the art upon review of the foregoing description that combinations of the above-described embodiments, as well as other embodiments not specifically described herein, will be apparent.

Claims

**Claim 1** A wearable extracorporeal defibrillator, comprising: one or more sensing electrodes configured to engage the patient's skin for detecting a cardiac signal; a defibrillation electrode pad configured to engage the patient's skin, configured to deliver an electrical therapy to the patient, and configured to be in continuous electrical communication with the patient's skin; an adhesive material, the one or more sensing electrodes, the defibrillation electrode pad, and a fluid moving element configured to move fluid away from the skin to enable the wearable extracorporeal defibrillator to be continuously worn during exercise or shower activities, a patient engagement substrate comprising the same; an energy source; a controller configured to detect the cardiac signal by the sensing electrodes and to deliver a therapeutic shock to the patient through the defibrillation pad while the patient engagement substrate is engaged with the patient; A wearable extracorporeal defibrillator comprising the above components. **Claim 2** A wearable extracorporeal defibrillator, comprising: one or more sensing electrodes configured to engage the patient's skin for detecting a cardiac signal; a defibrillation electrode pad configured to engage the patient's skin, configured to deliver an electrical therapy to the patient, and configured to be in continuous electrical communication with the patient's skin; an elastic element configured to conform to the one or more sensing electrodes, the defibrillation electrode pad, and the patient's skin and to stretch with the patient's skin to enable the wearable extracorporeal defibrillator to be continuously worn during exercise or shower activities, a patient engagement substrate comprising the same; an electrical energy source; a controller configured to detect the cardiac signal by the sensing electrodes and to deliver a therapeutic shock to the patient through the defibrillation pad while the patient engagement substrate is engaged with the patient; A wearable extracorporeal defibrillator comprising the above components. **Claim 3** A second patient engagement substrate comprising a second defibrillation electrode pad, a second adhesive material, and a second plurality of sensing electrodes, wherein the second defibrillation electrode pad is configured to engage the skin of the patient and deliver electrical therapy to the patient, the second defibrillation electrode pad is configured to be in continuous electrical communication with the skin of the patient, and the second defibrillation electrode is in electrical communication with the electrical energy source, the second patient engagement substrate The wearable extracorporeal defibrillator according to claim 1 or 2, further comprising.

4. A battery and one or more capacitors, wherein the controller is configured to charge the one or more capacitors with the battery and discharge the one or more capacitors through the defibrillation electrode pad, the one or more capacitors, and the second defibrillation electrode pad, wherein the electrical energy source includes the one or more capacitors The wearable defibrillator according to any one of claims 1 to 3, further comprising.

5. The wearable defibrillator according to claim 4, wherein the battery, the one or more capacitors, and the controller are enclosed in a housing connected to the patient engagement substrate.

6. The wearable defibrillator according to claim 4, wherein the battery, the one or more capacitors, and the controller are enclosed in two or more separate housings connected to the patient engagement substrate.

7. The wearable defibrillator according to claim 5 or 6, wherein the housing is configured to allow water vapor to pass through the housing from the inner surface to the outer surface.

8. The inner surface of the housing is permeable to water vapor, and the water vapor can pass through from the inner surface to the outer surface at an average moisture transmission rate based on the surface area of the patient engagement substrate exceeding about 250 g / m ２ per day. The wearable defibrillator according to claim 7.

9. The wearable defibrillator according to any one of claims 5 to 8, wherein the housing is breathable.

10. The wearable defibrillator according to any one of claims 5 to 9, wherein the outer surface of the housing is hydrophobic.

11. The wearable defibrillator according to any one of claims 5 to 10, wherein the outer surface of the housing is water-resistant.

12. The wearable defibrillator according to any one of claims 5 to 11 further comprises a fluid transfer layer in fluid communication with the patient engagement substrate within the housing, and the fluid transfer layer is configured to enhance fluid mobility across the entire patient engagement substrate.

13. The wearable defibrillator according to claim 12, wherein the fluid transfer layer has an absorption capacity exceeding about 500%.

14. The wearable defibrillator according to any one of claims 12 to 13, wherein the fluid transfer element includes the adhesive material and the fluid transfer layer.

15. The wearable defibrillator according to any one of claims 12 to 14, wherein the fluid transfer layer is configured to move fluid across the entire major surface area of the fluid transfer layer.

16. The wearable defibrillator according to any one of claims 12 to 15 further comprises an absorbent material within the housing.

17. The wearable defibrillator according to claim 16, wherein the transfer element includes the absorbent material.

18. The wearable defibrillator according to claim 17, wherein the transfer element includes the housing.

19. The wearable defibrillator according to any one of claims 5 to 18 further comprises one or more waterproof housings surrounding the one or more capacitors, the battery, and the controller.

20. The wearable defibrillator according to any one of claims 5 to 19 further comprises a support layer configured to engage and support the controller, the one or more capacitors, and the battery.

21. The ratio of the total weight of the one or more capacitors, the battery, and the controller to the surface area of the patient contact substrate is about 2 g / cm ２ The wearable defibrillator according to any one of claims 5 to 20, which is less than.

22. The battery, the one or more capacitors, and the controller of the wearable defibrillator according to claim 4 are enclosed in a housing separate from the patient engagement substrate and the second patient engagement substrate.

23. The patient engagement surface has an average moisture permeability based on the surface area of the patient engagement substrate that exceeds about 10 g / m ２ per day, for the wearable defibrillator according to any one of claims 1 to 22.

24. The patient engagement surface has an average moisture permeability based on the surface area of the patient engagement substrate of more than about 50 g / m ２ per day, for the wearable defibrillator according to any one of claims 1 to 23.

25. The patient engagement surface has an average moisture permeability based on the surface area of the patient engagement substrate of more than about 100 g / m ２ per day, for the wearable defibrillator according to any one of claims 1 to 24.

26. The patient engagement surface has an average moisture permeability based on the surface area of the patient engagement substrate of more than about 150 g / m ２ per day, the wearable defibrillator according to any one of claims 1 to 25.

27. The patient engagement surface has an average moisture permeability based on the surface area of the patient engagement substrate of more than about 200 g / m per day. ２ The wearable defibrillator according to any one of claims 1 to 26.

28. The patient engagement surface has an average moisture permeability based on the surface area of the patient engagement substrate of more than about 250 g / m ２ per day, and the wearable defibrillator according to any one of claims 1 to 27.

29. The wearable defibrillator according to any one of claims 2 to 28, wherein the elastic element has an average elastic modulus of from about 0.40 MPa to about 0.9 MPa.

30. The wearable defibrillator according to any one of claims 1 to 29, wherein the patient engagement substrate has an average elastic modulus of from about 0.40 MPa to about 0.9 MPa.

31. The patient-engaging substrate has an average elastic modulus of less than about 5.0 MPa, the wearable defibrillator according to any one of claims 1 to 30.

32. The patient-engaging substrate has an average elastic modulus of less than about 2.0 MPa, the wearable defibrillator according to any one of claims 1 to 30.

33. The one or more capacitors have a total rated capacitance exceeding about 50 μF, the wearable defibrillator according to any one of claims 4 to 32.

34. The one or more capacitors have a total voltage exceeding about 100 V, the wearable defibrillator according to any one of claims 4 to 33.

35. The wearable defibrillator according to any one of claims 1 to 34, further comprising a flexible bridge connecting the first patient-engaging substrate and the second patient-engaging substrate.

36. The flexible bridge includes a conductor configured to provide electrical communication from the second defibrillation pad electrode and the second plurality of ECG sensing electrodes to one or more of the controller and the one or more capacitors, the wearable defibrillator according to claim 35.

37. The adhesive material includes an adhesive border along an outer peripheral portion of the first patient-engaging substrate configured to adhere to the wearable defibrillator and the skin of the patient, and the wearable defibrillator has a tapered cross-sectional shape along the adhesive border from a side portion of the adhesive border facing the center of the wearable defibrillator to an outer edge of the adhesive border, the wearable defibrillator according to any one of claims 1 to 36.

38. The wearable defibrillator according to any one of claims 1 to 37, further comprising a wireless data communication module within the housing.

39. The wearable defibrillator according to any one of claims 1 to 38, further comprising one or more sensors within the housing.

40. The sensor includes one or more of a GPS sensor, an accelerometer, a microphone, and a gyroscope, the wearable defibrillator according to claim 39.

41. The wearable defibrillator has a moisture transfer rate from the first patient engagement substrate to the outside of the housing based on the surface area of the first patient engagement substrate of about 250 g / m per day ２ that exceeds, of the wearable defibrillator according to any one of claims 1 to 40.

42. The first defibrillation pad electrode includes a hydrogel and a carbon fiber fabric structure, the wearable defibrillator according to any one of claims 1 to 41.

43. The wearable defibrillator has a water transfer rate from the second patient engagement substrate to the outside of the outer layer based on the surface area of the second patient engagement substrate of about 250 g / m per day ２ that exceeds ２ , and the wearable defibrillator according to any one of claims 1 to 42.

44. The wearable defibrillator according to any one of claims 1 to 43, further comprising a user interface.

45. The patient-worn substrate has an average moisture permeability of about 500 g / m per day ２ and exceeds that of any one of claims 1 to 44 of the wearable defibrillator.

46. The fluid movement element has an average moisture permeability based on the surface area of the patient engagement substrate of more than about 50 g / m ２ per day, and the wearable defibrillator according to any one of claims 1 to 45.

47. The fluid transfer element has an average water permeability based on the surface area of the patient engagement substrate of more than about 250 g / m ２ per day, and the wearable defibrillator according to any one of claims 1 to 46.

48. The wearable defibrillator according to any one of claims 1 to 47, wherein the adhesive material in the patient engagement substrate includes perforated holes.

49. The wearable defibrillator according to claim 48, wherein the perforated holes have a diameter of about 0.5 mm to about 2 mm.

50. The wearable defibrillator according to claim 48 or 49, wherein the perforated holes of the adhesive material have an opening area of about 10% to about 25% of the total surface area of the adhesive material.

51. The wearable defibrillator according to any one of claims 2 to 50, wherein the elastic element includes the adhesive material.

52. The wearable defibrillator according to any one of claims 1 to 51, wherein the wearable external defibrillator is configured to be continuously worn during exercise and shower activities for a long time exceeding about 24 hours.

53. The wearable defibrillator according to any one of claims 1 to 52, wherein the wearable external defibrillator is configured to be continuously worn during exercise and shower activities for a long time exceeding about 5 days.

54. The wearable defibrillator according to any one of claims 1 to 53, wherein the wearable external defibrillator is configured to be continuously worn during exercise and shower activities for a long time exceeding about 7 days.

55. The wearable defibrillator according to any one of claims 1 to 54, wherein the wearable external defibrillator is configured to be continuously worn during exercise and shower activities for a long time exceeding about 10 days.

56. A patient engagement substrate including an adhesive material, one or more sensing electrodes, and a defibrillation electrode pad; A fluid communication layer in fluid communication with the patient engagement substrate; A battery, one or more capacitors, and a controller housed in one or more electronic circuit housings; A support layer connected to the electronic circuit housing and the patient engagement substrate; An outer housing connected to a portion of the patient engagement substrate, wherein the one or more electronic circuit housings are between the outer housing and the patient engagement substrate; and the outer housing; A wearable external defibrillator comprising.

57. The wearable defibrillator according to claim 56, further comprising an absorption layer in fluid communication with the fluid communication layer.

58. The patient engagement substrate has an average moisture transmission rate based on the surface area of the patient engagement substrate of more than about 250 g / m ２ per day, the wearable defibrillator according to claim 56.

59. A second patient engagement substrate including a second defibrillation electrode pad, a second adhesive, and a second plurality of sensing electrodes, and a second fluid communication layer in fluid communication with the second patient engagement substrate, wherein the second defibrillation electrode pad is configured to engage the skin of the patient and deliver an electrical treatment to the patient, and the second defibrillation electrode pad is configured to be continuously electrically communicative with the skin of the patient. The wearable defibrillator according to claim 56.

60. The average moisture permeability based on the surface area of the second patient engagement substrate exceeds about 250 g / m per day for the wearable defibrillator according to claim 59. ２ ​

61. The wearable defibrillator according to any one of claims 56 to 60, wherein the outer housing is breathable.

62. The wearable defibrillator according to any one of claims 56 to 61, wherein the outer surface of the outer housing is hydrophobic.

63. The wearable defibrillator according to any one of claims 56 to 62, wherein the outer surface of the outer housing is water resistant.

64. The wearable defibrillator according to any one of claims 56 to 63, wherein the fluid communication layer has an absorption capacity of more than about 500%.

65. The wearable defibrillator according to any one of claims 56 to 64, further comprising a waterproof housing surrounding the one or more capacitors, the battery, and the controller.

66. The wearable defibrillator according to any one of claims 56 to 65, wherein the patient engagement substrate has an average elastic modulus of from about 0.40 MPa to about 0.9 MPa.

67. The wearable defibrillator according to any one of claims 56 to 66, wherein the one or more capacitors have a total rated capacitance of more than about 50 μF.

68. The wearable defibrillator according to any one of claims 56 to 67, wherein the one or more capacitors have a total voltage of more than about 100 V.

69. The wearable defibrillator according to any one of claims 56 to 68, further comprising a wireless data communication module within the housing.

70. The wearable defibrillator according to any one of claims 56 to 69, further comprising one or more sensors within the housing.

71. The sensor includes one or more of a GPS sensor, an accelerometer, a microphone, and a gyroscope, and is the wearable defibrillator according to claim 70.

72. The adhesive material within the patient engagement substrate includes perforated holes, and is the wearable defibrillator according to any one of claims 56 to 71.

73. The perforated holes have a diameter of about 0.5 mm to about 2 mm, and is the wearable defibrillator according to claim 72.

74. The perforated holes of the adhesive material have an opening area that is about 10% to about 25% of the total surface area of the adhesive material, and is the wearable defibrillator according to claim 72.

75. The fluid communication layer has an average moisture permeability based on the surface area of the patient engagement substrate of greater than about 50 g / m ２ per day, the wearable defibrillator according to any one of claims 56 to 74.

76. The fluid communication layer has an average water permeability based on the surface area of the patient engagement substrate that exceeds about 250 g / m ２ per day, for the wearable defibrillator of claim 75.

77. A wearable extracorporeal defibrillator, A first patient engagement substrate including an adhesive material, one or more sensing electrodes, and a first defibrillation electrode pad, wherein the one or more sensing electrodes are configured to engage the patient's skin to detect a cardiac signal, and the first defibrillation electrode pad is configured to engage the patient's skin and deliver an electrical treatment to the patient, and the first defibrillation electrode pad is configured to be continuously in electrical communication with the patient's skin, the first patient engagement substrate; A housing, wherein the housing is connected to the first patient engagement substrate to form an internal space between the housing and the first patient engagement substrate, and the internal portion includes a battery, one or more capacitors, and a controller, and the first defibrillation electrode pad is in electrical communication with the one or more capacitors, the housing; A second patient engagement substrate including a second defibrillation electrode pad, a second adhesive material, and a second plurality of sensing electrodes, wherein the second defibrillation electrode pad is configured to engage the patient's skin and deliver an electrical treatment to the patient, and the second defibrillation electrode pad is configured to be continuously in electrical communication with the patient's skin, and the second defibrillation electrode is in electrical communication with the one or more capacitors, the second patient engagement substrate; A fluid movement element configured to enable the wearable extracorporeal defibrillator to be continuously worn for a period longer than 24 hours by moving fluid away from the skin. The controller is configured to charge the one or more capacitors with the battery and discharge the one or more capacitors through the first defibrillation electrode pad and the second defibrillation electrode pad. Wearable external defibrillator.

78. The wearable external defibrillator according to claim 77, wherein the wearable external defibrillator is configured to be continuously worn for a long time exceeding about 5 days, even during exercise or shower activities.

79. The wearable external defibrillator according to claim 77, wherein the wearable external defibrillator is configured to be continuously worn for a long time exceeding about 7 days, even during exercise or shower activities.

80. The wearable external defibrillator according to claim 77, wherein the wearable external defibrillator is configured to be continuously worn for a long time exceeding about 10 days, even during exercise or shower activities.

81. The wearable defibrillator has an average moisture permeability from the first patient engagement substrate, through the housing connected to the first patient engagement substrate, based on the surface area of the first patient engagement substrate, of about 250 g / m ２ per day, exceeding that of the wearable defibrillator according to claim 77.

82. The first patient engagement substrate has an average moisture transmission rate of about 500 g / m per day ２ The wearable defibrillator according to claim 77, which exceeds

83. The wearable defibrillator according to any one of claims 77 to 82, wherein the first and second patient engagement substrates have an average elastic modulus of about 0.40 MPa to about 0.9 MPa.

84. The wearable defibrillator according to any one of claims 77 to 83, wherein the housing is breathable.

85. The wearable defibrillator according to any one of claims 77 to 84, wherein the outer surface of the housing is hydrophobic.

86. The wearable defibrillator according to any one of claims 77 to 85, wherein the outer surface of the housing is water-resistant.

87. The fluid transfer element further includes a fluid transfer layer in the housing that is in fluid communication with the first patient engagement substrate, and the fluid transfer layer is configured to enhance the fluidity of water across the entire first patient engagement substrate. The wearable defibrillator according to any one of claims 77 to 86.

88. The wearable defibrillator according to claim 87, wherein the fluid transfer layer has an absorption capacity exceeding about 500%.

89. The wearable defibrillator according to claim 87, further comprising an absorbent material in the housing.

90. The wearable defibrillator according to any one of claims 77 to 89, further comprising one or more waterproof housings surrounding the one or more capacitors, the battery, and the controller.

91. The wearable defibrillator according to any one of claims 77 to 90, further comprising a support layer configured to engage with and support the controller, the one or more capacitors, and the battery.

92. The ratio of the total weight of the one or more capacitors, the battery, and the controller to the surface area of the patient engagement substrate is less than about 2 g / cm ２ The wearable defibrillator according to any one of claims 77 to 91.

93. The wearable defibrillator according to any one of claims 77 to 92, wherein the one or more capacitors have a total rated capacitance exceeding about 50 μF.

94. The wearable defibrillator according to any one of claims 77 to 93, wherein the one or more capacitors have a total voltage exceeding about 100 V.

95. The wearable defibrillator according to any one of claims 77 to 94, further comprising a flexible bridge connecting the first patient-engaging substrate and the second patient-engaging substrate.

96. The wearable defibrillator according to claim 95, wherein the flexible bridge includes a conductor configured to provide electrical communication from the second defibrillation pad electrode and the second plurality of ECG sensing electrodes to one or more of the controller and the one or more capacitors.

97. The adhesive material includes an adhesive border along an outer periphery of the first patient-engaging substrate configured to adhere the wearable defibrillator to the skin of the patient, and the wearable defibrillator has a tapered cross-sectional shape along the adhesive border from a side portion of the adhesive border facing the center of the wearable defibrillator to an outer edge of the adhesive border. The wearable defibrillator according to any one of claims 77 to 96.

98. The wearable defibrillator according to any one of claims 77 to 97, further comprising a wireless data communication module within the housing.

99. The wearable defibrillator according to any one of claims 77 to 98, further comprising one or more sensors within the housing.

100. The wearable defibrillator according to claim 99, wherein the sensor includes one or more of a GPS sensor, an accelerometer, a microphone, and a gyroscope.

101. The wearable defibrillator according to any one of claims 77 to 100, wherein the first defibrillation pad electrode includes a hydrogel and a carbon fiber fabric structure.

102. The adhesive material within the patient engagement substrate of the wearable defibrillator according to any one of claims 77 to 101 includes perforated holes.

103. The wearable defibrillator according to claim 102, wherein the perforated holes have a diameter of from about 0.5 mm to about 2 mm.

104. The wearable defibrillator according to claim 102, wherein the perforated holes of the adhesive material have an opening area that is from about 10% to about 25% of the total surface area of the adhesive material.

105. One or more sensing electrodes configured to engage the patient's skin for detecting cardiac signals, A defibrillation electrode pad configured to engage the patient's skin, configured to deliver electrical therapy to the patient, and configured to be in continuous electrical communication with the patient's skin, An adhesive material, the one or more sensing electrodes, the defibrillation electrode pad, and a fluid movement element configured to move fluid away from the skin to enable the wearable extracorporeal defibrillator to be continuously worn during movement or shower activities, a patient engagement substrate comprising: Comprising a patient engagement surface.

106. The patient engagement surface according to claim 105, further comprising an elastic element configured to conform to the patient's skin and stretch with the patient's skin to enable the wearable extracorporeal defibrillator to be continuously worn during movement or shower activities for a period of time exceeding 7 days.

107. The patient engagement surface according to any one of claims 105 to 106, configured to be continuously worn during movement or shower activities for a period of time exceeding about 24 hours.

108. The patient engagement surface according to any one of claims 105 to 107, configured to be continuously worn during movement or shower activities for a period of time exceeding about 5 days.

109. The patient engagement surface according to any one of claims 105 to 108, configured to be continuously worn during movement or shower activities for a period of time exceeding about 10 days.

110. The patient engagement surface according to any one of claims 105 to 109, wherein the defibrillation pad includes a carbon fiber fabric structure.

111. The patient engagement surface according to any one of claims 105 to 110, further comprising a second defibrillation electrode pad.

112. The patient engagement surface according to any one of claims 105 to 111, further comprising an electronic circuit module that is in electrical communication with the defibrillation electrode pad and the second defibrillation electrode pad.

113. A wearable extracorporeal defibrillator according to any one of claims 1 to 112, and one or more of an adhesive release agent, a skin cleanser, a hair removal tool, and instructions for attaching the wearable defibrillator. A kit comprising.

114. A method for monitoring and defibrillating a patient's heart, comprising: Adhering a first patient engagement substrate comprising a first plurality of sensing electrodes and a first defibrillation pad to a first skin surface portion of the patient, wherein the first defibrillation pad is in electrical communication with an electrical energy source sufficient to deliver a defibrillation shock, and the first patient engagement substrate portion of the wearable defibrillator comprises a fluid moving element configured to move fluid away from the first skin surface portion of the patient to enable continuous wearing of the wearable extracorporeal defibrillator during exercise or shower activities, the step of adhering to the first skin surface portion; Adhering a second patient engagement substrate comprising a second plurality of sensing electrodes and a second defibrillation pad to a second skin surface portion of the patient, wherein the second defibrillation pad is in electrical communication with the electrical energy source sufficient to deliver the defibrillation shock, and the second patient engagement portion of the wearable defibrillator, the step of adhering to the second skin surface portion; Measuring electrical data corresponding to the patient's heart signal with the first plurality of sensing electrodes and the second plurality of sensing electrodes; A method including.

115. The method according to claim 114, wherein the fluid moving element moves fluid away from the first skin portion and towards the outside of the housing of the wearable defibrillator.

116. The method according to any one of claims 114 to 115, wherein the fluid moving element moves fluid from end to end of a major cross-sectional area of the fluid moving element.

117. The average water permeability of the fluid moving element to the first skin surface portion of the patient is greater than about 50 g / m per day ２ The method according to any one of claims 114 to 116, wherein the method exceeds the above value.

118. The average moisture permeability of the fluid moving element to the first skin surface portion of the patient is about 250 g / m per day ２ The method according to any one of claims 114 to 117, which exceeds this value.

119. The method according to any one of claims 114 to 118, wherein the fluid movement element includes an adhesive material and a suction material, and the adhesive material is part of the first patient engagement substrate and the second patient engagement substrate.

120. The method according to any one of claims 114 to 119, further comprising analyzing the electrical data to determine whether the patient has a treatable arrhythmia.

121. The method according to any one of claims 114 to 120, further comprising detecting one or more of the patient's pulse, respiratory rate, heart sound, and heart rate.

122. The method according to claim 121, further comprising analyzing one or more of the detected patient's pulse, respiratory rate, heart sound, and heart rate to confirm a treatable arrhythmia.

123. The method according to any one of claims 114 to 122, further comprising delivering an electric shock after determining that the patient has a treatable arrhythmia.

124. The method according to claim 123, further comprising measuring the patient's transthoracic impedance between the first defibrillation pad electrode and the second defibrillation pad electrode before delivering the electric shock.

125. The method according to any one of claims 114 to 124, further comprising continuously wearing the wearable defibrillator for a long period of time exceeding about 24 hours.

126. The method according to any one of claims 114 to 125, further comprising continuously wearing the wearable defibrillator for a long period of time exceeding about 5 days.

127. The method according to any one of claims 114 to 126, further comprising continuously wearing the wearable defibrillator for a long period of time exceeding about 7 days.

128. A method of treating a patient with a wearable defibrillator, comprising: Receiving ECG data from a plurality of ECG sensing electrodes that form part of the wearable defibrillator and are configured to be worn for a long period of time and to be in continuous electrical contact with the patient's skin; Analyzing the ECG data to determine whether the patient has a treatable arrhythmia; After determining a treatable arrhythmia, immediately detecting one or more of the patient's pulse, respiratory rate, heart sound, and heart rate; Analyzing the one or more of the detected pulse, respiratory rate, heart sound, and heart rate of the patient to confirm a treatable arrhythmia; Measuring the transthoracic impedance of the patient between a first defibrillation pad electrode and a second defibrillation pad electrode, wherein the first defibrillation pad electrode and the second defibrillation pad electrode are configured to be worn for a long period of time and to be in continuous electrical contact with the patient's skin, and the first defibrillation pad electrode and the second defibrillation pad electrode form part of the wearable defibrillator, the step of measuring the transthoracic impedance of the patient; Instructing a controller to charge a plurality of capacitors within the wearable defibrillator; Delivering a therapeutic electrical shock to the patient through the first defibrillation electrode pad and the second defibrillation electrode pad; A method comprising.

129. The method according to claim 128, further comprising wirelessly transmitting data corresponding to the position of the patient to an emergency medical service after determining a treatable arrhythmia.

130. The method according to claim 128, further comprising wirelessly transmitting data corresponding to the position of the patient to an emergency contact of the patient after determining a treatable arrhythmia.

131. The method according to claim 128, wherein the step of measuring the transthoracic impedance includes determining whether the first defibrillation pad electrode and the second defibrillation pad electrode are in electrical contact with the patient's skin.

132. The method according to claim 128, further comprising adjusting the therapeutic electrical shock based on the transthoracic impedance.

133. The method according to claim 128, further comprising generating an audible alarm to warn the patient that a therapeutic electrical shock may occur before the step of instructing the controller to charge the plurality of capacitors.

134. The method according to claim 133, further comprising instructing the controller to charge the plurality of capacitors when a shut-off button of the wearable defibrillator is not pressed.

135. A method for monitoring and defibrillating a patient's heart, comprising: Engaging a patient engagement substrate comprising an adhesive, one or more sensing electrodes, defibrillation electrode pads, and an elastic element with the patient's skin; Measuring a cardiac signal with the one or more sensing electrodes; Supporting a controller configured to monitor a battery, an electrical energy source, and the one or more sensing electrodes, charge the one or more capacitors with the battery, and deliver electrical therapy to the patient by discharging the electrical energy source through the defibrillation electrode pads, in electrical contact with the one or more sensing electrodes and the defibrillation electrode pads; Continuously performing the engaging, measuring, and supporting steps for at least 24 hours; A method comprising the steps of.

136. The method of claim 135, wherein the elastic element has an average elastic modulus of from about 0.40 MPa to about 0.9 MPa.

137. The method of claim 135, wherein the engaging, measuring, and supporting steps are continuously performed for at least about 48 hours.

138. The method of claim 135, wherein the engaging, measuring, and supporting steps are continuously performed for at least about 5 days.

139. The method of claim 135, wherein the engaging, measuring, and supporting steps are continuously performed for at least 7 days.

140. The method of claim 135, wherein the engaging, measuring, and supporting steps are continuously performed for at least 10 days.

141. The method according to any one of claims 135 to 141, wherein the engaging, measuring, and supporting steps are continuously performed even during activities such as exercise and showering.

142. The device according to any one of claims 1 to 112, wherein the patient engagement surface has an average elasticity exceeding about 0.40 MPa.

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