Abstract: This disclosure is directed to devices, systems, and techniques for managing storing sensed information. In some examples, a system includes a memory and processing circuitry. The processing circuitry may be configured to receive evoked compound action potential (ECAP) information, wherein the ECAP information comprises information from a plurality of evoked compound action potential (ECAP) signals, receive a trigger signal requesting long-term storage of at least a portion of the ECAP information in the memory, and responsive to receiving the trigger signal, store the at least portion of the ECAP information in the memory.

Abstract: In some examples, a method for controlling delivery of cardiac therapy and cardiac sensing by a medical device system including electrodes for delivering the cardiac therapy may include storing, in a memory of the medical device system, a respective value for each of a plurality of cardiac therapy and/or sensing parameters and, in association with each of a plurality of heart position states, a respective modification of at least one of the cardiac therapy and/or sensing parameters. Such a method also may include determining a current one of the plurality of heart position states of the patient, modifying the at least one cardiac therapy and/or sensing parameter value according to the modification associated with the current heart position state, and controlling the delivery of the cardiac therapy and/or cardiac sensing according to the modified at least one cardiac therapy and/or sensing parameter value.

Abstract: Various embodiments of a speaker and a method of forming such speaker are disclosed. The speaker includes a frame having a first major surface, a second major surface, and an opening disposed between the first and second major surfaces; a cone disposed adjacent the first major surface of the frame; and an adhesive layer disposed on at least a portion of the second major surface of the frame. The adhesive layer occludes the opening of the frame.

Abstract: Subcutaneous implantation tools and methods of implanting a subcutaneous device using the same. The tool may include a tool body having a longitudinally extending recess having a distal opening and having a tunneler at a distal end of the tool body extending from the distal opening of the recess. The tool may include a plunger slidably fitting within at least a portion of the tool body recess. The recess may be configured to receive an implantable device and the tunneler preferably extends distally from the recess at a position laterally displaced from the device when the device is so located in the recess. Movement of the plunger distally within the recess advances the device distally out of the recess and alongside of and exterior to the tunneler.

Abstract: An implantable cardiac defibrillator (ICD) system includes an ICD implanted subcutaneously in a patient, a defibrillation lead having a proximal portion coupled to the ICD and a distal portion having a defibrillation electrode configured to deliver a defibrillation or cardioversion shock to a heart of the patient, and a pacing lead that includes a distal portion having one or more electrodes and a proximal portion coupled to the ICD. The distal portion of the pacing lead is implanted at least partially along a posterior side of a sternum of the patient within the anterior mediastinum. The ICD is configured to provide pacing pulses to the heart of the patient via the pacing lead and provide defibrillation shocks to the patient via the defibrillation lead. As such, the implantable cardiac system provides pacing from the substernal space for an extravascular ICD system.

Abstract: Systems and methods of manufacturing 3D printed medical devices. The method includes feeding a first filament and a second filament into an interior cavity of a heating cartridge and melting each of the filaments on a substrate. The heating cartridge is then moved linearly and rotationally relative to the substrate to form a jacket including material from each of the first and second filaments. Further, rotating the substrate provides a uniform mixture and creates support rings between the filament materials within the structure of the jacket.

Abstract: In some examples, processing circuitry of a medical device system determines, for each of a plurality of patient parameters, a difference metric for a current period based on a value of a patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period, and determines a score for the current period based on a sum of the difference metrics for at least some of the plurality of patient parameters. The processing circuitry determines a threshold for the current period based on scores determined for N periods that precede the current period, compares the score for the current period to the threshold, and determines whether to generate an alert indicating that an acute cardiac event of the patient, e.g., ventricular tachyarrhythmia, is predicted, and/or deliver a therapy configured to prevent the acute cardiac event, based on the comparison.

Abstract: Trays and packaging systems for a prosthesis delivery device that permit conversion from a packaged, storage/or shipping configuration to a loading configuration for the loading of a prosthesis. The prosthesis may be a prosthetic heart valve. In the packaged configuration, the delivery device can be supported within the tray, which includes a recess and at least one clip maintaining the delivery device within the recess. In the loading configuration, the delivery device can be arranged for loading of the prosthesis within a bath area of the tray. Optionally, the delivery device can be stored in the packaged configuration in a U-shape. Some embodiments include an additional recess for positioning an indeflator fluid line or tubing. Methods of use are also disclosed.

Abstract: A pacemaker having a motion sensor is configured to select an atrial event sensing vector of a multi-axis motion sensor for sensing atrial systolic events from a motion signal produced by the motion sensor. In some examples, the pacemaker determines a maximum amplitude during a sensing window for each one of multiple vector signals produced by the multi-axis motion sensor. The pacemaker may select the atrial event sensing vector signal from among the vector signals based on the determined maximum amplitudes.

Abstract: An implantable device and associated method for delivering multi-site pacing therapy is disclosed. The device comprises a set of electrodes including a first and second left ventricular electrodes spatially separated from one another and a right ventricular electrode, all coupled to an implantable pulse generator. The processing circuit coupled to the implantable pulse generator, the processing circuit configured to determine whether a prospective heart failure condition has occurred and if so to trigger the pulse generator to switch from a first pacing mode to a second pacing mode, the first pacing mode comprising delivering only a first pacing pulse to a left ventricle (LV) and thereafter delivering an RV pacing pulse to the right ventricular electrode within a single cardiac cycle and the second pacing mode comprising delivering first and a second pacing pulses to the LV and thereafter delivering an RV pacing pulse to the right ventricular electrode within a single cardiac cycle.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: A method and system for determining a location of a treatment element relative to an anatomical feature and for estimating contact between the treatment element and the anatomical feature in the context of a navigation system. The system may include a medical device including at least one treatment element and at least one navigation electrode and a navigation system in communication with the one or more navigation electrodes, the navigation system including a processing unit. The processing unit may be programmed to determine a plurality of points that define a surface geometry of the at least one treatment element, calculate a distance between each of the points and a closest point on the anatomical feature, and estimate the likelihood of contact between the points.

Abstract: The present disclosure provides methods and techniques associated with a planar transformer for an apparatus. The planar transformers include a substrate carrying electronic components and a continuous core that is formed by distributing the encapsulant material uniformly around the substrate unit to define a consistent cross-sectional area for the magnetic path. The electronic components include primary windings and secondary windings associated with the transformer. In some embodiments, the encapsulant material is molded to seals air gaps to the substrate unit.

Abstract: A lithium ion battery is provided that includes: a positive electrode; a negative electrode; a separator comprising a material having a melt temperature of greater than 150° C.; and an electrolyte including an organic solvent and a lithium salt. A method for sterilizing a lithium ion battery is also provided that includes: providing a lithium ion battery (particularly one as described herein); either charging or discharging the battery to a state of charge (SOC) of 20% to 100%; and steam sterilizing the battery to form a sterilized lithium ion battery.

Abstract: This disclosure relates to methods, devices, and systems for delivering and adjusting stimulation therapy. In one example, a method comprising delivering, by a stimulation electrode, electrical stimulation as a candidate therapy to a patient according to a set of candidate therapy parameters, the stimulation electrode located in proximity to the dorsal column of a patient; sensing, by a sensing electrode, an electrically evoked compound action potential (eECAP) signal in response to the delivery of the electrical stimulation; and classifying, by a processor, the sensed eECAP signal generated in response to the application of the candidate therapy relative to an eECAP baseline is disclosed.

Abstract: A workpiece of Ti or a Ti alloy includes a surface with a coating layer of titanium nitride. A region of the surface includes a connection zone of a Ti—N solid solution alloy. A second Ti or Ti alloy workpiece is contacted with the connection zone, and a weld joint is formed across the connection zone with a resistance welding process. The weld joint extends into the first Ti workpiece and the second Ti workpiece.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: A transcatheter delivery device including a catheter and at least one stabilizer useful for transseptal procedures. The stabilizer includes a shaft connected to an anchor. The anchor has a delivery position in which the anchor is collapsed against the shaft and a deployed position in which the anchor expands to engage a pulmonary vein or atrial appendage to support the catheter within the septal wall as the catheter moves within a left atrium. Various disclosed delivery devices are also configured to ablate tissue proximate the anchor and/or can be disconnected from the delivery device after the procedure to occlude an atrial appendage. Methods of using the disclosed delivery devices and treating a heart are also disclosed.