Abstract: Methods and devices are provided comprising an implantable lead having electrodes configured to be located proximate to a heart, the electrodes defining a sensing vector through a region of interest in the heart. The method and system collect an intra-cardiac electrogram (EGM) signal associated with an event of interest and determining an global amplitude characteristic (GAC) and a global slope characteristic (GSC) from the EGM signal under control of one or more processors within an implantable medical device (IMD). A QRS start time is defined, within the EGM signal, based on the GSC and determining a local amplitude characteristic (LAC) for a segment of the EGM signal within a search window of the GAC under control of one or more processors within an implantable medical device (IMD) A QRS end time is defined, within the EGM signal, based on the LAC; and calculating a QRS duration based on the QRS start time and QRS end time under control of one or more processors within an implantable medical device (IMD).

Abstract: Computer implemented methods, devices and systems for monitoring a trend in heart failure (HF) progression are provided. The method comprises sensing left ventricular (LV) activation events at multiple LV sensing sites along a multi-electrode LV lead. The activation events are generated in response to an intrinsic or paced ventricular event. The method implements program instructions on one or more processors for automatically determining a conduction pattern (CP) across the LV sensing sites based on the LV activation events, identifying morphologies (MP) for cardiac signals associated with the LV activation events and repeating the sensing, determining and identifying operations, at select intervals, to build a CP collection and an MP collection. The method calculates an HF trend based on the CP collection and MP collection and classifies a patient condition based on the HF trend to form an HF assessment.

Abstract: Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.

Abstract: An implantable medical device (IMD) that includes a transceiver configured to broadcast an advertising data packet that includes a unique identifier, and to receive a scan request data packet from an external device. A memory stores program instructions, and stores an approved device list, and one or more processors are configured to execute the program instructions to identify a device identifier (ID) from the scan request data packet received, apply an advertising filter to determine if the scan request data packet is from an authorized external device based on the device ID and the approved device list, based on the determination by the advertising filter, deny transmission of a scan response data packet from the transceiver when the advertising filter determines that the scan request data packet is from an unauthorized external device, and establish a communication session with an authorized external device independent of the scan request data packet.

Abstract: A method, system and external instrument are provided. The method initiates a communication link between an external instrument (EI) and an implantable medical device (MD), established a first connection interval for conveying data packets between the EI and IMD and monitors a connection criteria that includes at least one of a data throughput requirement. A battery indicator or link condition of the communications link is between the IMD and EI. The method further changes from the first connection interval to a second connection interval based on the connection criteria.

Abstract: Systems and methods are provided for managing patient activated capture of transient data by an implantable medical device (IMD). The systems and methods collect transient data using the IMD. The collected transient data is stored in a temporary memory section of the IMD. The IMD receives a patient activated storage request including activation information related to a patient designated trigger point from an external device. The IMD transfers a segment of the transient data from the temporary memory section to a long-term memory, wherein the segment of transferred transient data is based on the trigger point. The activation information includes an elapsed time corresponding to a duration of time between entry of the trigger point and issuance of the patient activated storage request by an external activation device.

Abstract: Methods and devices are provided for, under control of one or more processors within an implantable medical device (IMD), delivering cardiac resynchronization therapy (CRT) at one or more pacing sites. The processors obtain cardiac signals, associated with a candidate beat, from multi-site left ventricular (MSLV) electrodes distributed along a left ventricle and analyze the cardiac signals to collect at least one of a MSLV conduction pattern or a MSLV morphology. The processors compare at least one of the MSLV conduction pattern or MSLV morphology to one or more associated templates. The processors then label the candidate beat as a pseudo-fusion beat based on the comparing and adjust the CRT based on the labeling.

Abstract: A method of processing a metal foil to produce a cathode for an electrolytic capacitor includes printing one or more layers of conductive ink on the metal foil to form a pattern of cathode plates, each of the one or more layers being a predetermined thickness, and the pattern arranged at a distance from a cathode tab and an edge of the cathode plates. The method also includes heating the deposited one or more layers of conductive ink to evaporate a solvent within the conductive ink such that conductive particles of the conductive ink remain deposited on the metal foil. The method further includes sintering the conductive particles and cutting the cathode plates from the metal foil, thereby producing the cathode plates suitable for use in the electrolytic capacitor.

Abstract: Described herein are apparatuses and methods that improve conductive communication between an external programmer and an implantable medical device (IMD) that is implanted within a patient. In an embodiment, an auxiliary apparatus of the present technology includes a first auxiliary skin electrode configured to attach to skin of a patient, a second auxiliary skin electrode configured to attach to skin of a patient, and an electrically conductive path extending between the first and second auxiliary skin electrodes and interrupted by a capacitor. The auxiliary apparatus is distinct from the external programmer and the IMD, and can beneficially be used to improve conductive communication therebetween without making any modifications to the external programmer, and without making any modifications to the IMD.

Abstract: Circuits, devices and methods are provided to manage modifications to protected registers within an implantable medical device (IMD). The circuit comprises a bus controller that includes an address register, an unlock register and a protected register (PR) enable unit. The PR enable unit sets a protect enable signal to an access state based on content loaded into the unlock register. A peripheral block includes a protected register that retains content for operating the IMD. The peripheral block includes a register access input to receive the protected enable signal. A PR write control unit is provided to enable an attempted write of the content from a data interface to the protected register when the protected enable signal has an access state.

Abstract: Methods and devices for establishing secure communications with an implantable medical device (IMD) are provided. The method and devices receive a credential from an external instrument (EI). The credential is signed utilizing a private key, and the credential includes at least two of a credential time to live (TTL) indicator, an IMD Identifier (ID), and an EI ID. The method and device authenticate the credential using a public key and verify the at least two of the TTL indicator, the IMD ID, and the EI ID. The method and device establish a secure communications session with the EI based on the verification and authentication.

Abstract: Disclosed herein is a medical tool adapted to engage and disengage with leadless pacemakers to allow for the repeated use of the tool in delivering and implanting multiple leadless pacemakers into a patient heart in a serial or repeated manner. The tool includes a handle, an attachment mechanism, a torque portion, and a rotation limiter. The handle includes a housing. The attachment mechanism is operably coupled to the housing and configured to actuate between a released state and an engaged state. The torque portion is operably coupled to the housing and rotatable relative to the housing to transition the attachment mechanism between the released and engaged states. The torque portion includes a shaft. The rotation limiter is in sliding engagement with the shaft between a first stop and a second stop. The rotation limiter includes a first helical thread. The tool also includes a second helical thread in threaded engagement with the first helical thread and operably coupled to the housing.

Abstract: Systems and methods for managing bi-directional communication between an external device (ED) and an implantable medical device (IMD) are provided. The method comprises receiving an active ED configuration and a request for communications parameters to be used with the active ED configuration. The method further comprises identifying a pre-existing configuration, from a collection of pre-existing configurations that match the active ED configuration, the collection of pre-existing configurations having an associated collection of predefined parameter sets. The method further determines a resultant parameter set from the collection of predefined parameter sets based on the pre-existing configuration identified and returns the resultant parameter set in connection with the request, the resultant parameter set to be utilized by the ED for bi-directional communication with the IMD.

Abstract: Disclosed herein is an electrode feedthru assembly for an electronic device and method of manufacturing. The feedthru assembly includes a ferrule, an electrode assembly, and an elastomer. The ferrule includes a bore through which the electrode assembly is positioned. The electrode assembly includes an electrode wire attached to a crimp pin. The crimp pin includes a crimp terminal portion and a pin terminal portion, the crimp terminal portion being crimped to a portion of the electrode wire to form a connected portion of the electrode assembly. The elastomer is disposed in the bore of the ferrule between the ferrule and the electrode assembly. The elastomer electrically isolates the ferrule from the electrode assembly and encapsulates at least the connected portion of the electrode assembly.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: Devices and methods are provided for an implantable medical device (IMD) comprising a device housing having electronic components therein, a feedthrough assembly joined to the device housing, an antenna assembly, and a header body mounted to the device housing and enclosing the antenna assembly and feedthrough assembly. The antenna assembly including an inner conductor, a dielectric material, and an outer conductor arranged to form a coaxial structure.

Abstract: Methods for implanting a puke generator (PG) within a pectoral region of a chest of a patient and devices having the PG. The PG has a housing that includes a PG electrode. Methods also include implanting at least one lead having first and second electrode segments with the first electrode segment positioned along an anterior of the chest of the patient and the second electrode segment positioned along at least one of a posterior of the patient or a side of the patient. The first and second electrode segments are positioned subcutaneously at or below an apex of a heart of the patient, wherein the PG electrode and the first and second electrode segments are configured to provide electrical shocks for antiarrhythmic therapy.

Abstract: Methods and devices include making an incision at a single site of a patient. The single site located at an anterior of a chest or abdomen. The method also includes inserting a tunneling tool through the incision at the single site and preparing a first tunnel to a subcutaneous posterior location. A path of the first tunnel at least one of i) extends over a plurality of Intercostal gaps of the chest or ii) extends along and within one of the intercostal gaps. The method also includes positioning a first lead having an electrode within the first tunnel and preparing a second tunnel to a subcutaneous parasternal location along the chest. The method also includes positioning a second lead having an electrode within the second tunnel and positioning a pulse generator within a subcutaneous pocket and operatively coupling the first and second leads to the pulse generator.

Abstract: A computer implemented method and system for confirming a device documented arrhythmia in cardiac activity are provided. The method is under control of one or more processors configured with executable instructions. The method obtains a cardiac activity (CA) data set that includes CA signals for a series of cardiac events and includes device documented (DD) markers within the series of cardiac events. The device documented markers are indicative of atrial fibrillation (AF) detected by the ICM utilizing an on-board R-R interval irregularity (ORI) process to analyze the CA signals. The method applies a feature enhancement function to the CA signals to form modified CA signals with enhanced sinus features and analyzes the enhanced sinus features in the modified CA signals. The method utilized a confirmatory feature detection process to identify false AF detection by the ORI process. The method records a result of the analysis identifying false AF detection by the ORI process.

Abstract: Methods and systems are provided for detecting arrhythmias in cardiac activity. The methods and systems declare a current beat, from the CA signals, to be a candidate beat or an ineligible beat based on whether the current beat satisfies the rate based selection criteria. The determining and declaring operations are repeated for multiple beats to form an ensemble of candidate beats. The method and system calculate a P-wave segment ensemble from the ensemble of candidate beats, perform a morphology-based comparison between the P-wave segment ensemble and at least one of a monophasic or biphasic template, declare a valid P-wave to be present within the CA signals based on the morphology-based comparison, and utilize the valid P-wave in an arrhythmia detection process to determine at least one of an arrhythmia entry, arrhythmia presence or arrhythmia exit.