Abstract: Examples for controlling electrical stimulation therapy are described. One example includes delivering a pulse train at a frequency to a patient, the pulse train comprising a plurality of first pulses at least partially interleaved with a plurality of second pulses, wherein the plurality of first pulses are configured to facilitate sensing elicited electrical signals, each pulse of the plurality of first pulses having an active first phase and active second phase. Each pulse of the plurality of second pulses may include an active first phase and a passive second phase. Additionally, or alternatively, the plurality of second pulses may alternate between a cathodic active first phase and an anodic active first phase according to a ratio. At least one pulse of the plurality' of second pulses may have an interphase interval that is longer than an interphase interval of at least one pulse of the plurality of first pulses.

Abstract: An example method includes receiving one or more physiological signals; detecting an apnea event based on the one or more physiological signals; determining that the apnea event cannot be characterized as one of a normal, OSA (obstructive sleep apnea), CSA (central sleep apnea), or combination OSA/CSA event; and outputting an electrical stimulation as a default based on determining that the apnea event cannot be characterized as a normal event, an OSA event, a CSA event, or combination OSA/CSA events.

Abstract: An epidural space is cleared of fat and scar tissue in preparation for implantation of a medical lead by utilizing a clearing tool. The clearing tool has an outer body and an inner body present within a lumen of the outer body. The outer body may be malleable and have a pre-set deflection or may be flexible and achieve deflection when being inserted into the epidural space. Once in the epidural space, the inner body is extended distally from the lumen of the outer body such that a distal tip on the inner body extends further into the epidural space to provide clearing to the target site without requiring further ingress of the outer body. The inner body is retracted and the clearing tool is removed. The medical lead is then inserted through the window and cleared epidural space until reaching the target site.

Abstract: Various embodiments of a hermetic assembly and a method of forming such assembly are disclosed. The hermetic assembly includes a dielectric substrate having a first major surface and a second major surface, a patterned layer connected to the first major surface of the dielectric substrate by a laser bond, and a ferrule having a body and a flange extending from the body. The flange is welded to a welding portion of the patterned layer that is disposed between the flange and the first major surface of the dielectric substrate such that the ferrule is hermetically sealed to the dielectric substrate.

Abstract: Techniques, systems, and devices are disclosed for delivering stimulation therapy to a patient. In one example, a medical device determines a first set of stimulation parameters that define entrainment stimulation pulses configured to entrain electrical activity in a patient. The medical device may control a stimulation generator to generate the entrainment stimulation pulses according to the first set of stimulation parameters. The medical device may further determine a second set of stimulation parameters that define at least one desynchronization stimulation pulse configured to disrupt at least a portion of the electrical activity entrained by the entrainment stimulation pulses. The medical device may subsequently control the stimulation generator to generate the desynchronization stimulation pulse(s) according to the second set of stimulation parameters.

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: 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: 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: 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: 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: 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: 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: 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.