Abstract: System and methods are provided for determining a stimulation threshold for closed loop spinal cord stimulation (SCS). The system and methods provide a lead coupled to an implantable pulse generator (IPG). The system and methods deliver SCS pulses from the IPG to the lead electrodes in accordance with an SCS therapy and determine an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS therapy. The system and methods increase the SCS therapy by increasing at least one of an amplitude, a duration, and number of the SCS pulses associated with the SCS therapy. The system and methods also include iteratively repeat the delivering, determining and increasing operations until the ECAP amplitude exhibits a downward trend divergence. The system and methods define a stimulation threshold based on the ECAP amplitude at the trend divergence.

Abstract: A biostimulator transport system, such as a biostimulator retrieval system, having a torque limiter to allow a torque shaft to slip rotationally relative to a handle, is described. The torque limiter can connect the torque shaft to the handle, and can include a slip mechanism, such as a flat spring or apposed clutch faces, that allow the torque shaft to slip relative to the handle when a resistance torque at a distal end of the torque shaft exceeds a torque threshold. Accordingly, torque can be applied to a biostimulator by the torque shaft with a reduced likelihood of over-torqueing the biostimulator within the target tissue. Other embodiments are also described and claimed.

Abstract: A method of manufacturing an electrolytic capacitor includes impregnating an electrolytic capacitor with a first electrolyte to form a first impregnated capacitor, aging the first impregnated capacitor using a first aging process to form a first aged capacitor, impregnating the first aged capacitor with a second electrolyte to form a second impregnated capacitor, the second electrolyte being different from the first electrolyte, aging the second impregnated capacitor using a final aging process to form a final aged capacitor, and impregnating the final aged capacitor with a third electrolyte.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.

Abstract: Described herein are implantable medical systems, and methods for use therewith, that provide a temperature based rate response for a patient within which the implantable medical system is implanted. Such a method can include sensing a blood temperature signal indicative of a core body temperature of the patient, and producing a relative temperature signal based on the blood temperature signal. The method can further include producing a moving baseline temperature signal based on the relative temperature signal, producing a proportional response signal based on the relative temperature signal and the moving baseline temperature signal, and producing a sensor indicated rate response signal based on the proportional response signal and a base rate. The sensor indicated rate response signal can also be based on a dip response signal and/or a slope response signal. Additionally, a pacing rate is controlled based on the sensor indicated rate response signal.

Abstract: Implementations described and claimed herein provide systems and methods for delivering and retrieving a leadless pacemaker. In one implementation, a leadless pacemaker has a docking end, and the docking end having a docking projection extending from a surface. A docking cap has a body defining a chamber. The docking cap has a proximal opening into the chamber. The proximal opening is coaxial with a longitudinal axis of a lumen of a catheter. A retriever has a flexible grasper with a first arm disposed opposite a second arm. Each of the first arm and the second arm form a hinge biased radially outwards from the longitudinal axis. The docking cap locks the first arm and the second arm on the docking projection when the body is sheathed over the retriever until the flexible grasper is disposed within the chamber.

Abstract: External devices, methods for use therewith, and systems including an external device and an implantable medical device (IMD) are described. A method includes receiving at the external device, using each of first, second, and third subsets of at least three external electrodes, conductive communication pulses transmitted by the IMD, and determining, for each subset of the external electrodes, a respective metric indicative of power and/or quality of the conductive communication pulses received from the IMD using the subset of external electrodes. The method further includes identifying, based on results of the determining, a preferred one of the first, second, and third subsets of the at least three external electrodes, and using the preferred one of the first, second, and third subsets of the at least three external electrodes to receive further conductive communication pulses transmitted by the IMD.

Abstract: Fabricating the electrode blank includes baking a blank precursor. The blank precursor contains the components of an electrode active medium including an active material. Fabricating the electrode blank also includes performing one or more post-bake calender operations on the blank precursor after baking the blank precursor. Each post-bake calender operation includes calendering the blank precursor.

Abstract: Systems and methods described herein improve visibility of P-waves of an EGM or ECG signal segment to be displayed on a display screen. There is a determination of whether relatively small features, including the P-waves, of the ECG or EGM signal segment would be difficult to visualize if an original signal segment range of the ECG or EGM signal segment were caused to be displayed on the display screen. In response to determining that the relatively small features of the ECG or EGM signal segment would be difficult to visualize, a portion of the EGM or ECG signal segment is displayed on the display screen in a manner that magnifies the P-waves of the EGM or ECG signal segment compared to if an entirety of the EGM or ECG signal segment within the original signal segment range were instead caused to be displayed on the display screen.

Abstract: Systems and methods described herein improve visibility of features (e.g., P-waves) of a physiologic signal segment (e.g., an EGM or ECG signal segment) to be displayed within a display band having a specified height between an upper and a lower boundary of the display band. The physiologic signal segment is divided into sub-segments, for each of which a sub-segment minimum peak amplitude and maximum peak amplitude are determined. Based thereon, a new minimum peak amplitude and a new maximum peak amplitude are determined and used to determine a new display range. A portion of the physiologic signal segment that is within the new display range is caused to be display, within the display band having the specified height, such that the upper boundary of the display band corresponds to the new maximum peak amplitude, and the lower boundary of the display band corresponds to the new minimum peak amplitude.

Abstract: Described herein are implantable medical devices (IMDs), and methods for use therewith. In certain embodiments, a controller of an IMD controls when a pacing capacitor of the IMD is charged using a first voltage, when the pacing capacitor is being charged using a second voltage, and when the pacing capacitor is discharged to deliver a pacing pulse between anode and cathode electrodes of, or electrically coupled to, the IMD. By selectively charging the pacing capacitor for a portion of a charge duration using the second voltage, that is greater in magnitude than the first voltage that is used for delivering the pacing pulse, a magnitude of a polarization artifact superimposed on an evoked response within a cardiac electrical signal, sensed using a sensing circuit of the IMD, is reduced compared to if the pacing capacitor were instead charged using the first voltage for the entire charge duration.

Abstract: A system for verifying a candidate pathologic episode of a patient is provided. The system includes an accelerometer configured to be implanted in the patient, the accelerometer configured to obtain accelerometer data along at least one axis. The system also includes a memory configured to store program instructions and one or more processors. When executing the program instructions, the one or more processors are configured to obtain a biological signal and identify a candidate pathologic episode based on the biological signal, analyze the accelerometer data to identify a physical action experienced by the patient, and verify the candidate pathologic episode based on the physical action.

Abstract: A system for validating safety of a medical device in a presence of a magnetic resonance imaging (MRI) field is provided. The system includes a first electric field generating device configured to form first electric field and configured to receive a medical device at least partially within the first electric field, and a second electric field generating device configured to form a second electric field in proximity to the first electric field and configured to receive the medical device at least partially within the second electric field.

Abstract: A computer implemented method for determining heart arrhythmias based on cardiac activity that includes under control of one or more processors of an implantable medical device (IMD) configured with specific executable instructions to obtain far field cardiac activity (CA) signals at electrodes located remote from the heart, and obtain acceleration signatures, at an accelerometer of the IMD, indicative of heart sounds generated during the cardiac beats. The IMD is also configured with specific executable instructions to declare a candidate arrhythmia based on a characteristic of at least one R-R interval from the cardiac beats, and evaluate the acceleration signatures for ventricular events (VEs) to re-assess a presence or absence of at least one R-wave from the cardiac beats and based thereon confirming or denying the candidate arrhythmia.

Abstract: Methods, devices and program products are provided for under control of one or more processors within an implantable medical device (IMD). Sensing near field (NF) and far field (FF) signals are between first and second combinations of electrodes coupled to the IMD. The method applies an arrhythmia detection algorithm to the NF signals for identifying events within the NF signal and designates events marker based thereon and monitors the event markers to detect a candidate arrhythmia condition in the NF signals. The candidate under-detected condition comprises at least one of an under-detected arrhythmia or over-sensing. In response to detection of the candidate arrhythmia condition, the method analyzes the FF signals for a presence of an under-detected arrhythmia indicator. The method delivers an arrhythmia therapy based on the presence of the under-detected arrhythmia indicator in the FF signals and the candidate under-detected arrhythmia condition in the NF signals.

Abstract: A method of producing a capacitor electrode includes forming an oxide layer on a foil. The method also includes inducing defects in the oxide layer followed by reforming the oxide layer. The oxide layer is reformed so as to generate a reformed oxide layer that is an aluminum oxide with a boehmite phase and a pseudo-boehmite phase. The amount of the boehmite phase in the reformed oxide layer is greater than the amount of the pseudo-boehmite phase in the reformed oxide layer.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.

Abstract: Disclosed herein is a delivery system for delivering a leadless pacemaker. The delivery system may include a catheter, which may be a guide catheter. The catheter includes a distal end, a proximal end opposite the distal end, a lumen extending between the distal end and the proximal end, and a locking hub operably coupled to the proximal end. The locking hub includes a lumen segment of the lumen. In one implementation, self-biasing of the lumen segment places the lumen segment out of alignment with a rest of the lumen. Deflecting the lumen segment against the self-biasing of the lumen segment places the lumen segment in coaxial alignment with the rest of the lumen. In another implementation, self-biasing of the lumen segment reduces an inner diameter of the lumen segment and actuation of the locking hub expands the inner diameter.

Abstract: An implantable system includes an implantable medical device (IMD) and a non-transvenous lead that is configured to be implanted outside of a heart. The IMD includes an output configured to be connected at least to the lead, a current generator (CG) circuit configured to generate pacing pulses, a switching circuit coupled between the CG circuit and the output, one or more capacitors coupled in parallel with the CG circuit and the switching circuit, and a control circuit coupled to the CG circuit. The control circuit is configured to manage the CG circuit to generate the pacing pulses with a constant current at the output.