Abstract: Devices and methods are described for accessing the mediastinum without an intercostal incision and without deflating the lungs. In some embodiments, the devices and methods facilitate mediastinal access via a single percutaneous needle puncture. In some embodiments, a first puncture below the ribs or sternum, and a second puncture that is intercostal are used. Devices and methods to facilitate concurrent access to the pericardial and mediastinal spaces are also described. Multiple minimally invasive procedures are described that advantageously utilize the pericardial and mediastinal space access procedures.

Abstract: This document relates to devices and methods for the treatment of heart conditions. For example, this document provides devices and methods for treating heart failure with preserved ejection fraction, including diastolic heart failure, by performing a pericardial modification procedure. The methods for treating diastolic heart failure of a patient include: creating an opening in a parietal layer, and only in the parietal layer, of a pericardial tissue of the patient. The creation of this opening reduces pressure exerted by the pericardial tissue on a heart of the patient.

Abstract: Devices and methods can be used to treat dermatologic disorders, hyperhidrosis, and wrinkles using DC electroporation. In some cases, such electroporation is essentially non-thermal modulation that can be used to ablate keratinocyte neoplasms, such as seborrheic keratosis, and other non-keratinocyte derived neoplasms of the skin and adnexal structures and related structures in other anatomic sites. In some implementations, the devices and methods described herein can be used for therapy delivery for the treatment of early or pre-malignant skin cancers. In some implementations, the devices and methods described herein can be used for treatment of hyperhidrosis and cosmetic issues.

Abstract: This document describes methods and materials for improving the delivery of electroporation. For example, this document describes methods and devices for delivering electroporation while mitigating risks of ventricular fibrillation.

Abstract: This document describes implantable medical devices and methods of using such devices. The implantable medical devices include a cardiac lead sized for insertion in a cardiac cavity, the cardiac lead having a distal end and a proximal end and a lead body extending therebetween, a heat exchange module disposed at the distal end of the lead body, the heat exchange module comprising an enclosure having a first surface and a second surface, and one or more temperature sensors located within the enclosure.

Abstract: Devices and methods for the treatment of heart conditions, hypertension, and other medical disorders are described. For example, this document describes devices and methods for treating atrial fibrillation by performing thoracic vein ablation procedures, including pulmonary vein myocardium ablation. In some embodiments, the ablation is performed in coordination with the delivery a pharmacological agent that can abate the formation of tissue stenosis or neointimal hyperplasia caused by the ablation. Additionally, in some embodiments, particulate matter, such as thrombus or crystalline drug compounds, created during the ablation is captured and removed from the patient using devices and methods provided herein. Further, devices and methods for non-thermal methods of causing cell death, such as tissue suction and tissue stretching, are also described.

Abstract: The present disclosure relates generally to electroporation systems and utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. In some embodiments, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory. One or more sensors may be operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart. One or more electrodes for treatment may be disposed in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram.

Abstract: Embodiments of the present disclosure relate to treating diseased tissue with ablation therapy. In an embodiment, an apparatus comprises a catheter having an elongate body extending between a proximal end and a distal end. The apparatus further includes a balloon structure arranged proximal to the distal end of the catheter, wherein the balloon structure has a first portion with a first permeability and a second portion with a second permeability such that the first permeability is different than the second permeability. In addition, the apparatus includes a first electrode arranged on or within the balloon structure and configured to: transmit current through the first portion, receive current transmitted through the first portion or both.

Abstract: Systems, methods, and computer program product embodiments are disclosed for performing electrophysiology (EP) signal processing. An embodiment includes an electrocardiogram (ECG) circuit board configured to process an ECG signal. The embodiment further includes a plurality of intracardiac (IC) circuit boards, each configured to process a corresponding IC signal. The ECG circuit board and the plurality of IC circuit boards share substantially a same circuit configuration and components. The ECG circuit board further processes the ECG signal using substantially a same path as each IC circuit board uses to process its corresponding IC signal.

Abstract: The present disclosure relates generally to electroporation systems and utilizing algorithms for electroporation pulse delivery including a patient's EKG/EGM monitoring. In some embodiments, an electroporation delivery system may include an electrocardiogram operatively connected to a processing device and a memory. One or more sensors may be operatively connected to the electrocardiogram for measuring electrical activity QRS complex of a patient's heart. One or more electrodes for treatment may be disposed in, at, or near the patient's heart, the one or more electrodes operatively connected to a pulse delivery mechanism. The electroporation delivery system may be configured to determine whether an electroporation pulse is deliverable to a patient based on the electrocardiogram.

Abstract: Apparatuses and methods are provided to predict or diagnose an ischemic event, such as a stroke or a transient ischemic attack (TIA). A machine-learning model such as a neural network is generated that allows for recognition of an ECG consistent with an ischemic event. A system is trained and used to process a recording of ECG data from a patient to generate a prediction indicating a likelihood that the patient will experience a stroke. In other examples, a system is trained and used to process a recording of ECG data from a patient and detect an ischemic event for the patient who did not appear to have such an ischemic event.

Abstract: A wearable device combines its existing functions (e.g., a headphone) with non-invasive autonomic modulation using tragus or other external auditory meatus stimulation. The wearable device can output audio to a user, such as music, podcast, etc., and further provide modulation of the vagus nerve via tragus stimulation or other external auditory meatus stimulation to treat various diseases.

Abstract: Provided herein are methods, systems, and computer program products for the detection of pulmonary hypertension comprising receiving voltage-time data of a plurality of leads of an electrocardiograph of a subject; generating a feature vector from the voltage-time data; providing the feature vector to a pretrained learning system; and receiving from the pretrained learning system an indication of the presence or absence of pulmonary hypertension in the subject.

Abstract: Endolumenal devices and methods can be used for the treatment of health conditions including obesity and diabetes. In some embodiments, the methods and systems provided herein can cause weight loss or control diabetes by reducing the caloric absorption of an individual. For example, this document provides several devices and methods for treating obesity and diabetes by using electroporation to modulate the duodenal mucosa. In addition, this document provides devices and methods for bypassing portions of the gastrointestinal tract to reduce nutritional uptake.

Abstract: Systems, methods, devices, and techniques for analyzing and applying features of a T-wave derived from an electrocardiogram. A computing system can receive a set of data that characterizes an electrocardiogram of a patient. The system can analyze the set of data to identify a T-wave that occurs in the electrocardiogram. The system can determine values of one or more features of the T-wave and provide the information that identifies the values of the one or more features of the T-wave to a user.

Abstract: Systems, methods, and computer program product embodiments are disclosed for performing electrophysiology (EP) signal processing. An embodiment includes an electrocardiogram (ECG) circuit board configured to process an ECG signal. The embodiment further includes a plurality of intracardiac (IC) circuit boards, each configured to process a corresponding IC signal. The ECG circuit board and the plurality of IC circuit boards share substantially a same circuit configuration and components. The ECG circuit board further processes the ECG signal using substantially a same path as each IC circuit board uses to process its corresponding IC signal.

Abstract: Apparatuses and methods are provided to predict or diagnose an ischemic event, such as a stroke or a transient ischemic attack (TIA). A machine-learning model such as a neural network is generated that allows for recognition of an ECG consistent with an ischemic event. A system is trained and used to process a recording of ECG data from a patient to generate a prediction indicating a likelihood that the patient will experience a stroke. In other examples, a system is trained and used to process a recording of ECG data from a patient and detect an ischemic event for the patient who did not appear to have such an ischemic event.

Abstract: Devices and methods are provided for the treatment of pathological conditions including arrhythmias and trauma using temperature modulation via implantable or worn devices. For example, in one example embodiment this document relates to devices and methods for treating atrial or ventricular fibrillation by cooling the epicardium. The devices and methods can also be used to treat other disorders by applying heating and/or cooling to a patient in a number of different manners.

Abstract: Endolumenal devices and methods can be used for the treatment of health conditions including obesity and diabetes. In some embodiments, the methods and systems provided herein can cause weight loss or control diabetes by reducing the caloric absorption of an individual. For example, this document provides several devices and methods for treating obesity and diabetes by using electroporation to modulate the duodenal mucosa. In addition, this document provides devices and methods for bypassing portions of the gastrointestinal tract to reduce nutritional uptake.

Abstract: A wearable device combines its existing functions (e.g., a headphone) with non-invasive autonomic modulation using tragus or other external auditory meatus stimulation. The wearable device can output audio to a user, such as music, podcast, etc., and further provide modulation of the vagus nerve via tragus stimulation or other external auditory meatus stimulation to treat various diseases.