Abstract: Methods, devices and program products are provided for determining an early battery depletion condition for a battery powered device. The method determines a charge consumption drawn externally from a battery cell by the device for a select period of time, obtains a measured cell voltage for the battery cell of the medical device, calculates a projected cell voltage based on the charge consumption and usage conditions, and declares an early depletion condition based on a relation between the measured and projected cell voltages.

Abstract: A computer implemented method and device for providing dual chamber sensing with a single chamber leadless implantable medical device (LIMD) are provided. The method is under control of one or more processors in the LIMD configured with specific executable instructions. The method obtains a far field (FF) cardiac activity (CA) signals for activity in a remote chamber of a heart and compares the far field CA signals to a P-wave template to identify an event of interest associated with the remote chamber. The method sets an atrial-ventricular (AV) delay based on the P-wave identified and delivers pacing pulses at a pacing site of interest to a local chamber based on the AV delay.

Abstract: Systems and methods for implanting a medical device are provided and include an implantable lead comprising a lead body having a distal end and a proximal end. The implantable lead has electrodes positioned at the distal end and has a lead connector positioned at the proximal end. The lead connector includes lead contacts that are communicatively coupled to the electrodes positioned at the distal end. The lead body has a body outer envelope configured to fit within a lumen of an introducer sheath and the lead connector has a connector outer envelope configured to fit within the lumen of the introducer sheath. A pulse generator has a connector cavity. The lead adaptor is configured to interconnect the implantable lead and the pulse generator. The lead adaptor has an insertable connector that includes mating contacts and an adaptor cavity that includes cavity contacts.

Abstract: A system for supplying power transcutaneously to an implantable device implanted within a subject is provided. The system includes an external connector including one of a microneedle array and a microwire holder. The system further includes a power cable electrically coupled to the external connector and configured to supply power to the one of the microneedle array and the microwire holder, and an internal connector configured to be implanted within the subject and electrically coupled to the implantable device, the internal connector including the other of the microneedle array and the microwire holder. The microneedle array includes a plurality of electrically conductive microneedles, the microwire holder includes a plurality of electrical contacts, and the microwire holder is configured to engage the microneedle array such that the plurality of electrically conductive microneedles extend through the skin of the subject and electrically couple to the plurality of electrical contacts.

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: A computer implemented method and system to detect P-waves in cardiac activity is provided. The system includes memory to store specific executable instructions. One or more processors are configured to execute the specific executable instructions for obtaining far field cardiac activity (CA) signals for a series of beats, applying a P-wave template to at least one sub-segment of the CA signals to obtain an alignment indicator and calculating an amplitude dependence (AD) indicator based at least in part on the P-wave template and the at least one sub-segment. The system analyzes the alignment indicator based on a first criteria, compares the AD indicator with a second criteria, designates a candidate P-wave to be an actual P-wave based on the analyzing and comparing and records results of the designating.

Abstract: The present disclosure provides a grip sensor for quantifying pain experienced by a patient during spinal cord stimulation (SCS). The grip sensor includes an electronics enclosure, an annular outer shell substantially surrounding the electronics enclosure and sized to be held by the patient, a pressure sensor embedded in the outer shell and communicatively coupled to the electronics enclosure, the pressure sensor configured to measure a grip strength of the patient as SCS is applied to the patient, and a plurality of galvanic skin response sensors communicatively coupled to the electronics enclosure and configured to measure an electrical impedance of the skin of the patient as SCS is applied to the patient.

Abstract: A biostimulator, such as a leadless pacemaker, having electrode(s) coated with low-polarization coating(s), is described. A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.

Abstract: A biostimulator, such as a leadless pacemaker, having electrode(s) coated with low-polarization coating(s), is described. A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.

Abstract: A computer implemented method and system for detecting arrhythmias in cardiac activity are provided. The method is under control of one or more processors configured with specific executable instructions. The method obtains cardiac activity (CA) signals at the electrodes of an implantable medical device (IMD) in connection multiple cardiac beats and with different IMD orientations relative to gravitational force. The method obtains acceleration signatures at a sensor of the IMD that are indicative of heart sounds generated during the cardiac beats. The method obtains device location information at the IMD, with respect to the gravitational force during the cardiac beats. The method groups the acceleration signatures associated with the first and second set of cardiac beats into the corresponding one of first and second posture bins based on the device location information.

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: Computer implemented methods and systems for detecting arrhythmias in cardiac activity are provided. The method is under control of one or more processors configured with specific executable instructions. The method obtains a far field cardiac activity (CA) data set that includes far field CA signals for beats. The method applies a feature enhancement function to the CA signals to form an enhanced feature in the CA data set. The method calculates an adaptive sensitivity level and sensitivity limit based on the enhanced feature from one or more beats within the CA data set and automatically iteratively analyzes a beat segment of interest by comparing the beat segment of interest to the current sensitivity level to determine whether one or more R-waves are present within the beat segment of interest.

Abstract: Systems, devices, and methods for monitoring for atrial capture are disclosed. Such a method, for use within an implantable system including an atrial leadless pacemaker (aLP) and a ventricular leadless pacemaker (vLP), includes storing within a memory of the vLP a paced atrial activation morphology template corresponding to far-field atrial signal components expected to be present in a vEGM sensed by the vLP when an atrial pacing pulse delivered by the aLP captures atrial tissue. The vLP senses a vEGM and compares a morphology of a portion of the sensed vEGM to the paced atrial activation morphology template to determine whether a match therebetween is detected. Additionally, the vLP determines whether atrial capture occurred or failed to occur (responsive to an atrial pacing pulse), based on whether the vLP detects a match between the morphology of a portion of the sensed vEGM and the paced atrial activation morphology template.

Abstract: A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.

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: Computer implemented methods and systems for detecting arrhythmias in cardiac activity are provided. The method is under control of one or more processors configured with specific executable instructions. The method obtains a far field cardiac activity (CA) data set that includes far field CA signals for beats. The method applies a feature enhancement function to the CA signals to form an enhanced feature in the CA data set. The method calculates an adaptive sensitivity level and sensitivity limit based on the enhanced feature from one or more beats within the CA data set and automatically iteratively analyzes a beat segment of interest by comparing the beat segment of interest to the current sensitivity level to determine whether one or more R-waves are present within the beat segment of interest.

Abstract: The present disclosure provides systems and methods for classifying signals of interest in a cardiac rhythm management (CRM) device. A CRM device includes an intrinsic activation sensing circuit configured to pass signals falling within a first passband, a crosstalk sensing circuit configured to pass signals falling within a second passband, wherein the second passband contains higher frequencies than the first passband, and a computing device communicatively coupled to the intrinsic activation sensing circuit and the crosstalk sensing circuit, the computing device configured to classify a signal of interest as one of an intrinsic activation signal and a crosstalk signal based on whether the signal of interest is passed by the intrinsic activation sensing circuit and the crosstalk sensing circuit.

Abstract: A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.

Abstract: Computer implemented methods and systems are provided that comprise, under control of one or more processors of a medical device, where the one or more processors are configured with specific executable instructions. The methods and systems obtain motion data indicative of at least one of a posture or a respiration cycle; obtain cardiac activity (CA) signals for a series of beats; identify whether a characteristic of interest (COI) from at least a first segment of the CA signals exceeds a COI limit; analyze the motion data to determine whether at least one of the posture or respiration cycle at least in part caused the COI to exceed the COI limit. Based on the analyzing operation, the methods and systems automatically adjust a CA sensing parameter utilized by the medical device to detect R-waves in subsequent CA signals; and detect an arrhythmia based on a presence or absence of one or more of the R-waves in at least a second segment of the CA signals.

Abstract: Disclosed herein is a catheter for delivering an implantable medical lead to an implantation site near an ostium leading to a proximal region of a coronary sinus. The catheter includes a distal end, a proximal end opposite the distal end, a tubular body extending between the distal and proximal ends, an atraumatic fixation structure defining a distal termination of the distal end, and a lead receiving lumen. The atraumatic fixation structure is configured to enter the ostium and passively pivotally anchor with the proximal region of the coronary sinus. The lead receiving lumen extends along the tubular body from the proximal end to an opening defined in a side of the tubular body near the distal end and proximal the atraumatic fixation structure.