Abstract: A heart support device for circulatory assistance is disclosed. The device comprises a chamber body (10) defining a chamber having an internal volume configured to be filled with blood. The chamber body (10) has a first opening (12) and the chamber is dimensioned such that the first opening (12) and the chamber are fully disposed within a chamber of the human heart. A dynamic volume body (14) is provided and configured to be inflated or deflated to alternately increase or decrease the interior volume of the chamber. A catheter (16) comprising at least one lumen in fluid communication with the dynamic volume body is configured to deliver fluid to the dynamic volume body to inflate the dynamic volume body. A directional flow structure is configured to direct a flow of blood out of the chamber in a direction substantially aligned with a direction in which the catheter (16) extends.

Abstract: Disclosed are systems, devices, and methods that employ a pump to assist or support blood flow. An apparatus for pumping blood may include a pump housing having an outer wall disposed about a longitudinal pump axis, and having an upstream end and a downstream end; a blood flow straightener having a plurality of fins and positioned in the upstream end of the pump housing and secured to the pump housing by the plurality of fins; a diffuser having a plurality of diffuser fins and positioned in the downstream end of the pump housing and secured to the pump housing by the plurality of diffuser fins; and an impeller positioned between the blood flow straightener and the diffuser, and including a plurality of impeller blades. The apparatus may further include a pump drive configured to impart a rotational motion to the impeller by applying a magnetic field.

Abstract: An interface relay system for use with a fully implantable medical devices that permits transcutaneous coupling of the implanted medical device to a consumer electronics device. In one embodiment, coupling the implanted medical device to the external electronics device provides a back-up source of power for operating the implanted medical device. In another embodiment, coupling the implanted medical device to the external electronics device allows for providing unidirectional and/or bidirectional data transfer between the devices. In one arrangement, the consumer electronics device may be connectable to a communications/data network to allow for network communication between the implantable medical device and a remote processing platform/server.

Abstract: A system for performing a diagnostic or therapeutic procedure within a subject includes a device having a distal portion configured for insertion within a lumen or duct of the subject, the device including an elongate body having a longitudinal axis, the elongate body comprising a polymeric material and having a proximal end and a distal end, one or more electrically-conductive tracings carried on a first surface of the elongate body and configured to carry a signal, and one or more conductors embedded within the polymeric material and configured to carry a signal.

Abstract: A system may include electrodes on at least one lead configured to be operationally positioned for use in modulating a volume of neural tissue, a neural modulation generator configured to deliver energy using at least some electrodes to modulate the volume of neural tissue, a programming system configured to program the programmed modulation parameter set, including determine electrode fractionalizations for the electrodes based on a target multipole. The programmed parameter set may include the determined electrode fractionalizations. The target multipole may be used to determine electrode fractionalizations having at least three target poles that directionally and progressively stack fractionalizations of target poles to provide a linear electric field over the volume of tissue. The neural modulation generator may be configured to use the programmed modulation parameter set to provide the linear electric field over the volume of tissue.

Abstract: A wearable cardioverter defibrillator (WCD) comprises a support structure to be worn by a patient, an energy storage module to store an electrical charge, a discharge circuit coupled to the energy storage module, a measurement circuit, a user interface that includes a speaker, and a processor. The processor is configured to monitor a physiological signal of a patient with the measurement circuit to detect cardiac arrhythmia when the patient is wearing the support structure, determine whether a validation criterion is met in response to detection of a cardiac arrhythmia, provide no alarm with the user interface the validation criterion is being determined, and cause a shock to be delivered to the patient from the energy storage module by the discharge circuit in the event the validation criterion is met.

Abstract: An improved system for supporting (e.g., localization and/or positioning of) intravascular devices discussed herein provides for example a multi-element arrangement. A set of struts optionally projects from the intravascular device and contacts the vessel walls. The localization and positioning of the pump may be provided by the struts and/or by use of a tether opposing a propulsive force to ensure localization.

Abstract: The invention concerns a control device for controlling a blood flow of an intravascular blood pump for percutaneous insertion into a patient's blood vessel, the blood pump comprising a pump unit with a drive unit for driving the pump unit and configured to convey blood from a blood flow inlet towards a blood flow outlet, wherein the control device is configured to operate the blood pump in a selectable zero-flow control mode, wherein a blood flow command signal is selected, and the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow by adjusting a speed command signal for the drive unit, and the second controller is configured to control a drive speed of the drive unit.

Abstract: Disclosed is a method for computerizing delineation and/or multi-label classification of an ECG signal, including: applying a neural network to the ECG, labelling the ECG, and optionally displaying the labels according to time with the ECG signal.

Abstract: A system and method for cardiac activation imaging includes non-invasively or minimally invasively acquiring data about an electrical activation of a heart of a subject using at least one sensor. An activation image of the heart of the subject is reconstructed using a weighted sparse constrained reconstruction.

Abstract: Disclosed herein is an inflow cannula for an implantable blood pump assembly. The inflow cannula includes a tubular body that extends from a proximal end to a distal end. The tubular body includes a proximal portion adapted for connection to a pump housing, and a distal portion adapted for positioning within an opening formed in a heart. The inflow cannula further includes an expandable sleeve coupled to an exterior surface of the distal portion. The sleeve has a first portion coupled to the distal portion of the tubular body, and a second portion extending from the distal end of the tubular body. The second portion is deployable from a first, stored configuration to a second, deployed configuration in which the second portion expands radially to engage and conform to an endocardial surface of the heart.

Abstract: A method and apparatus for the quantitative determination of an individual's risk for sudden cardiac death (SCD) is described. Risk determination is accomplished and may have a sensitivity and specificity of greater than 95%, by generating linear and nonlinear mathematical digital ECG-constructed models from digital ECG-type data of an individual's digital ECG, determining stability/instability of digital ECG-constructed control model systems corresponding to the digital ECG-constructed models by a plurality of techniques and transforming stability/instability values obtained by the determining stability/instability into a quantitative value reflecting an individual's risk for SCD.

Abstract: An artificial intelligence-based interference recognition method for an electrocardiogram, comprising: cutting and sampling heart beat data of a first data amount, and inputting the heart beat data to be recognized that is obtained by cutting and sampling into an interference recognition binary classification model for interference recognition; in a sequence of the heart beat data, performing signal anomaly determination on a heart beat data segment where an inter-beat interval is greater than or equal to a preset interval determination threshold value, so as to determine whether the heart beat data segment is an abnormal signal; if the heart beat data segment is not an abnormal signal, determining a starting data point and an ending data point of sliding sampling in the heart beat data segment according to a set time with a preset time width, and performing sliding sampling on the data segment from the starting data point until the ending data point so as to obtain multiple sampling data segments; and using

Abstract: A method is implemented by a computer, and includes: (a) acquiring at least one set of waveform data having a time duration from physiological information waveform data; (b) classifying a waveform included in the waveform data into a predetermined type of waveform; (c) determining validity of a classification result of the waveform; and (d) correcting the classification result in accordance with the validity of the classification result.

Abstract: A motor device for stimulating muscle, including at least one electrode for generating electric current operatively attached to an electrode array and exposed on an inner surface of an array body, and a programming mechanism of a computer that executes an algorithm stored on non-transitory computer readable medium and includes an information storage mechanism and a user-operated interface in electrical connection with said at least one electrode for programming operation of said at least one electrode, said motor device being implanted in an individual and applying electric current to nerves at an area above an area of neurological damage.

Abstract: Apparatus and methods are described including manufacturing a housing for an impeller of a blood pump by placing an inner lining around a mandrel, placing a cylindrical portion of a frame around the inner lining, and placing a distal portion of an elongate tube around a portion of the frame. While the distal portion of the elongate tube is disposed around the portion of the frame, the inner lining, the frame, and the distal portion of the elongate tube are heated, via the mandrel, and pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame. Other applications are also described.

Abstract: A method for delivering electrical stimulation to alter a cognitive state of a user, the method comprising: monitoring a brain signal from the user via one or more intracranial electrodes implanted in the brain of the user while the user is presented with a stimulus; comparing the brain signal to a testing phase biomarker, wherein the testing phase biomarker is derived from a cognitive test performed on a contributor during a testing phase; delivering electrical stimulation to a brain of the user based on the comparing step to steer the brain of the user towards a high performance cognitive state.

Abstract: According to at least one example, an ambulatory medical device is provided. The device includes a plurality of electrodes disposed at spaced apart positions about a patient's body and a control unit. The control unit includes a sensor interface, a memory and a processor. The sensor interface is coupled to the plurality of electrodes and configured to receive a first ECG signal from a first pairing of the plurality of electrodes and to receive a second ECG signal from a second pairing of the plurality of electrodes. The memory stores information indicating a preferred pairing, the preferred pairing being either the first pairing or the second pairing. The processor is coupled to the sensor interface and the memory and is configured to resolve conflicts between interpretations of first ECG signal and the second ECG signal in favor of the preferred pairing.

Abstract: An external wearable medical device includes an electrode to detect patient cardiac activity; a therapy electrode to provide a therapy in response to detecting an arrhythmia event; a GUI display comprising a caregiver interface and a patient interface; and a processor configured to provide, to the caregiver interface, a first set of information that includes information for operating the device in conjunction with the patient and an alert history of the device including an indication of one or more detected arrhythmia events, provide, to the patient interface, a second set of information that includes information for allowing the patient to cause the device to suspend providing the therapy and a direction to the patient to contact a caregiver responsive to detecting an event affecting at least one of the device and the patient, and responsive to detecting the event, automatically transmitting a notification of the event to an external entity.

Abstract: Apparatus and methods are described including a left-ventricular assist device that includes a tube configured to traverse a subject's aortic valve, with a distal portion of the tube within the subject's left ventricle. A frame disposed within the distal portion of the tube defines cells, and a width of each of the cells within a cylindrical portion of the frame is less than 2 mm. An inner lining lines at least some of the cylindrical portion of the frame. An impeller is disposed inside the frame such that a gap between an outer edge of the impeller and the inner lining is less than 1 mm. The impeller is stabilized with respect to the frame, such that, during rotation of the impeller, the gap between the outer edge of the impeller and the inner lining is maintained and is substantially constant. Other applications are also described.