Abstract: Systems, methods and implantable devices configured to provide cardiac resynchronization therapy and/or bradycardia pacing therapy. A first device located in the heart of the patient is configured to receive a communication from a second device and deliver a pacing therapy in response to or in accordance with the received communication. A second device located elsewhere is configured to determine an atrial event has occurred and communicate to the first device to trigger the pacing therapy. The second device may be configured for sensing the atrial event by the use of vector selection and atrial event windowing, among other enhancements. Exception cases are discussed and handled as well.

Abstract: A method of making a feed-thru connector assembly includes inserting a conductor within an opening within a housing of a pulse generator and dispensing a sealant in a gap between the conductor and portions of the housing adjacent to the conductor that define the opening of the housing and curing the sealant to form a seal comprising a polyisobutylene cross-linked network.

Abstract: Systems and methods for managing machine-generated alert notifications of medical events detected from one or more patients are described herein. An embodiment of a data management system may receive an adjudication of a medical event episode including an episode characterization. A storage unit stores an association between one or more episode characterizations and corresponding detection algorithms for detecting a medical event having respective episode characterizations. An episode management circuit may detect from a subsequent episode, using the stored association, a medical event having an episode characterization of at least one medical event episode presented for adjudication, and schedule presenting at least a portion of the subsequent episode based on the detection.

Abstract: A method for making an insertable or implantable medical device including a lubricous coating on a silicone substrate includes treating the silicone substrate with an atmospheric plasma at about atmospheric pressure, the atmospheric plasma formed from a noble gas; applying a solution directly to the treated silicone substrate, the solution including a thermoplastic polyurethane; and heating the silicone substrate and the applied solution to form the lubricous coating on the silicone substrate.

Abstract: Systems and methods involve an intrathoracic cardiac stimulation device operable to provide autonomous cardiac sensing and energy delivery. The cardiac stimulation device includes a housing configured for intrathoracic placement relative to a patient's heart. A fixation arrangement of the housing is configured to affix the housing at an implant location within cardiac tissue or cardiac vasculature. An electrode arrangement supported by the housing is configured to sense cardiac activity and deliver stimulation energy to the cardiac tissue or cardiac vasculature. Energy delivery circuitry in the housing is coupled to the electrode arrangement. Detection circuitry is provided in the housing and coupled to the electrode arrangement. Communications circuitry may optionally be supported by the housing. A controller in the housing coordinates delivery of energy to the cardiac tissue or cardiac vasculature in accordance with an energy delivery protocol appropriate for the implant location.

Abstract: Systems, devices, and methods for monitoring and assessing immunotherapy toxicity are discussed. An exemplary system receives physiologic information from a patient using an ambulatory medical device. In response to an immunotherapy such as CAR T-cell therapy, the system determines a toxicity indication using the received physiologic information. A therapy can be initiated or adjusted using the toxicity indication.

Abstract: Various embodiment disclosed herein include a method for monitoring serum potassium in a patient. The method can include gathering cardiac electrogram data from the patient using two or more electrodes, separating the cardiac electrogram data into discrete subunits including a T-wave, aligning T-waves to create aligned discrete subunits, averaging the aligned discrete subunits to generate an average T-wave for the cardiac electrogram data, and determining a serum potassium value using the average T-wave for the cardiac electrogram data and a predetermined model relating T-wave values with serum potassium magnitudes.

Abstract: A catheter for delivering a medical electrical lead to a bundle of His from within a right atrium of a heart. The catheter includes a straight portion and a hook portion projecting from a distal end of the straight portion. The hook portion includes a first curved portion, a second curved portion, and a third curved portion. The straight portion and the first curved portion define a plane. The second curved portion extends from a distal end of the first curved portion. The second curved portion curves away from the plane. The third curved portion extends from a distal end of the second curved portion. The third curved portion curves toward the plane. The catheter forms a lumen extending from a proximal end of the straight portion to an opening at a distal end of the third curved portion.

Abstract: Embodiments herein relate to implantable medical devices including a power subunit with a first biocompatible electrically conductive shell configured for direct contact with an in vivo environment. In some embodiments a lithium anode can be disposed within the first biocompatible electrically conductive shell in direct electrical communication with a feedthrough pin, wherein the feedthrough pin is electrically isolated from the first biocompatible electrically conductive shell. A cathode can also be disposed within the first biocompatible electrically conductive shell and can be in direct electrical communication with the first biocompatible electrically conductive shell. The first biocompatible electrically conductive shell has a positive electrical potential. The implantable medical device further includes an electronics control subunit with a control circuit disposed within a second biocompatible electrically conductive shell. Other embodiments are included herein.

Abstract: A polymeric material includes a polyisobutylene-polyurethane block copolymer. The polyisobutylene-polyurethane block copolymer includes soft segments, hard segments, and end groups. The soft segments include a polyisobutylene diol residue. The hard segments include a diisocyanate residue. The end groups are bonded by urea bonds to a portion of the diisocyanate residue. The end groups include a residue of a mono-functional amine.

Abstract: Systems and methods for managing communication strategies between implanted medical devices. Methods include temporal optimization relative to one or more identified conditions in the body. A selected characteristic, such as a signal representative or linked to a biological function, is assessed to determine its likely impact on communication capabilities, and one or more communication strategies may be developed to optimize intra-body communication.

Abstract: An example of a system includes an implantable medical device (IMD) for implantation in a patient, where the IMD includes a cardiac pace generator, phrenic nerve stimulation (PS) sensor, a memory, and a controller, and where the controller is operably connected to the cardiac pace generator to generate cardiac paces. The controller is configured to provide a trigger for conducting a PS detection procedure and perform the PS detection procedure in response to the trigger. In performing the PS detection procedure the controller is configured to receive a signal from the sensor, detect PS using the signal from the sensor, and record the PS detection in storage within the IMD.

Abstract: Methods, systems and devices for providing cardiac resynchronization therapy (CRT) to a patient using a leadless cardiac pacemaker (LCP) and an extracardiac device (ED). The LCP is configured to deliver pacing therapy at a pacing interval. Illustratively, the ED may be configured to analyze the cardiac cycle including a portion preceding the pacing therapy delivery for one or several cardiac cycles, and determine whether an interval from the P-wave to the pace therapy in the cardiac cycle(s) is in a desired range. In an example, if the P-wave to pace interval is outside the desired range, the ED communicates to the LCP to adjust the pacing interval.

Abstract: An implantable medical device includes a device housing, a fixation device, a first prong projecting from a proximal end of the device housing and a second prong projecting from the proximal end of the device housing. The second prong is spaced apart from the first prong. The first prong includes a first flange projecting away from a longitudinal axis of the device housing. The second prong includes a second flange projecting away from the longitudinal axis. The first prong and the second prong are configured to extend to a first flange diameter in a relaxed configuration and to extend to a second flange diameter in an expanded configuration.

Abstract: A device for the active fixation of an implantable medical lead includes a housing, a tine assembly, and rotatable shaft. The housing includes a proximal end for connecting to the lead and a distal end opposite the proximal end. The housing defines a housing lumen having a longitudinal axis extending between the proximal end and the distal end. The tine assembly is disposed within the housing lumen. The tine assembly includes at least one tine configured to self-bias from a linear configuration within the housing to a curved configuration outside of the housing. The rotatable shaft extends through the housing lumen. The shaft is configured to engage the tine assembly such that rotation of the shaft transitions the at least one tine between the linear configuration and the curved configuration.

Abstract: Cardiac therapy devices in the form of pacemakers and/or defibrillators including one or more leads with electrodes implanted in a vein in a posterior position in combination with one or more leads with electrodes implanted in an anterior position. The posterior position may be chosen from one or more of the azygos, hemiazygos, accessory hemiazygos, or posterior intercostal veins. The anterior position may be chosen from the internal thoracic vein, an anterior intercostal vein, or an anterior subcutaneous location. In other examples, sensors are placed for use by a cardiac monitoring or therapy system in one or more of the internal thoracic vein, the azygos vein, the hemiazygos vein, the accessory hemiazygos vein, and/or an anterior or posterior intercostal vein.

Abstract: This document discusses, among other things, systems and methods to generate a first pacing waveform during a first pacing period and a second pacing waveform during a second pacing period, to alternate first and second pacing periods to provide pacing-based hypertension therapy to a heart of a patient to reduce patient blood pressure, to receive information indicative of patient metabolic demand, and to determine an adjusted pacing-based hypertension therapy parameter using the received information indicative of patient metabolic demand, wherein the first pacing waveform has a first atrioventricular (AV) delay and the second pacing waveform has a second AV delay longer than the first AV delay.

Abstract: Systems and methods for pacing cardiac conductive tissue are described. An embodiment of a medical system includes an electrostimulation circuit to generate His-bundle pacing (HBP) pulses to stimulate a His bundle, and a cardiac event detector to detect a His-bundle activity within a time window following an atrial activity. The cardiac event detector may use a cross-chamber blanking, or an adjustable His-bundle sensing threshold, to avoid or reduce over-sensing of far-field atrial activity and inappropriate inhibition of HBP therapy. The electrostimulation circuit may deliver HBP in the presence of the His-bundle activity. The system may further recognize the detected His-bundle activity as either a FFPW or a valid inhibitory event, and deliver or withhold HBP therapy based on the recognition of the His-bundle activity.

Abstract: Systems and methods for monitoring and treating patients with heart failure are discussed. The system may receive patient atrioventricular (AV) conduction characteristic under different heart rates or patient conditions. Stimulation parameters including stimulation timing parameters may be stored in a memory. The system may include a stimulation control circuit configured to determine a parameter update schedule indicating a timing at which to update stimulation parameter using patient AV conduction characteristic, and dynamically update at least a portion of the stored set of stimulation parameters at the determined parameter update schedule. For a specified heart rate or heart rate range, a stimulation parameter may be selected from the set of the stimulation parameters for use during cardiac stimulation.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an implantable medical device. The implantable medical device may include an implantable pacing member having a housing and a lead input. A lead may be coupled to the lead input. The lead may be designed to extend along a pericardial space, epicardium, or both and engage a heart chamber. A passageway may be defined along a portion of the length of the lead.