Pacesetter, Inc.

Paracor Medical, Inc.

Matthew G Fishler

Craig E Mar

Benjamin T Persson

Lilip Lau

Suresh K Gurunathan

Carl Lance Boling

Xiaoyi Min

Paul M Paspa

Thomas Blake Eby

Donald Chin

Thomas Robert Luhrs

Sondra Orts

David Ligon

Weiqun Yang

Steven Meyer

Shawn Chen

Anuja H Patel

James K Hong

Chunlan Jiang

Alex C Soriano

Brett C Villavicencio

Tyler J Strang

Kavous Sahabi

Russell Klehn

Arees Garabed

Matthew R Malone

Wes Alleman

Conor P Foley

Gene A Bornzin

Mark W Kroll

Gabriel A Mouchawar

Peter M Jacobson

Kenneth J Carroll

Stephen W Lee

Xiangqun Chen

Benjamin F James, Iv

Bruce Weir

Ivan Ma

Alan K Schaer

Eric Falkenberg

Alan Klenk

Reza Shahandeh

Keith Victorine

Ott Khouengboua

Joshua K Wallin

Thanh Tieu

Peter Martin

Drew A Hoffmann

Sieu T Duong

Mostafa Sadeghi

Anne M Street

Stephen Swift

Frank Lee

Suyashree Bhonsle

Sieu Dong

Jinto Zacharias

Robert Williams

Stephen Lee

Xiangqun Shawn Chen

Sondra Ortis

A biostimulator, such as a leadless cardiac pacemaker, including a fixation element to engage tissue and one or more backstop elements to resist back-out from the tissue, is described. The fixation element can be mounted on a housing of the biostimulator such that a helix of the fixation element extends distally to a leading point. The leading point can be located on a distal face of the helix at a position that is proximal from a center of the distal face. The backstop elements can include non-metallic filaments, such as sutures, or can include a pinch point of the biostimulator. The backstop features can grip the tissue to prevent unscrewing of the fixation element. Other embodiments are also described and claimed.

Biostimulator having fixation element

Described herein are external devices, and methods for use therewith, that are configured to communicate with one or more implantable medical devices (IMDs) implanted within a patient using conductive communication, wherein the external device includes or is communicatively coupled to at least three external electrodes that are in contact with the patient. Certain such methods involve the external device identifying, for each IMD, of the plurality of IMDs, which one of the plurality of communication vectors is a preferred communication vector for communicating with the IMD, based on respective indicators of conductive communication quality that are determined for the plurality of communication vectors. Certain embodiments involve determining when there should be a reassessment of which one of the plurality of communication vectors is the preferred communication vector for communicating with an IMD, and in response thereto, identifying an updated preferred communication vector for communicating with the IMD.

Devices, systems and methods for improving conductive communication between external devices and implantable medical devices

Methods, systems, and devices that detect arrhythmic episodes and perform arrhythmia discrimination are described. Such a system includes a leadless pacemaker (LP) that senses a near-field electrogram (NF-EGM), and a non-vascular implantable cardioverter defibrillator (NV-ICD) that senses a far-field electrogram (FF-EGM). The LP determines cardiac activity information based on the NF-EGM and optionally also based on paced cardiac events caused by the LP. The LP monitors for specific pacemaker condition(s), sends i2i message(s) including the cardiac activity information to the NV-ICD when at least one of the specific pacemaker condition(s) is detected by the LP, and does not send i2i message(s) including the cardiac activity information to the NV-ICD when the LP detects none of the specific pacemaker condition(s) After the NV-ICD receives the i2i message(s) transmitted by the LP, the NV-ICD can detect an arrhythmic episode and/or perform arrhythmia discrimination based on the cardiac activity information included therein.

Systems and methods for using leadless pacemaker to assist non-vascular implantable cardiac defibrillator

Methods and systems for terminating a pacemaker mediated tachycardia (PMT) are described herein. During a period that a PMT is not detected, an implantable system delivers an atrial pacing pulse to an atrial cardiac chamber in response to a PA interval expiring without an intrinsic atrial event being detected during the PA interval. The systems performs atrial sensing to thereby monitor for intrinsic atrial events in the atrial cardiac chamber, performs ventricular sensing to thereby monitor for intrinsic ventricular events in a ventricular cardiac chamber, and detects the PMT. Additionally, the system, in response to the PMT being detected, initiates a PMT PA interval that is shorter than the PA interval that the system would otherwise use for atrial pacing if the PMT was not detected.

Methods and systems for terminating a pacemaker mediated tachycardia (PMT)

Implantable medical devices (IMDs) described herein, and methods for use therewith described herein, reduce how often an IMD accepts a false message and/or reduce adverse effects of an IMD accepting a false message. Such IMDs can be leadless pacemakers (LPs), or implantable cardio defibrillators (ICDs), but are not limited thereto. Such embodiments can be used help multiple IMDs (e.g., multiple LPs) implanted within a same patient maintain synchronous operation, such as synchronous multi-chamber pacing.

Mitigating false messages and effects thereof in multi-chamber leadless pacemaker systems and other IMD systems

A leadless biostimulator has a housing including an electronics compartment, an electronics assembly mounted in the electronics compartment, a proximal electrode that disposed on and/or integrated into the housing, and an electrical feedthrough assembly. The electrical feedthrough assembly includes a distal electrode and a flange. The flange is mounted on the housing. The distal electrode is electrically isolated from the flange by an insulator and configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A mount is mounted on the flange and thereby mounted on the electrical feedthrough assembly. A fixation element is mounted on the mount and configured to facilitate fixation of the leadless biostimulator to tissue of a patient.

Leadless biostimulator and electrical feedthrough assembly for leadless biostimulator

Embodiments described herein relate to implantable medical devices (IMDs) and methods for use therewith. Such a method includes using an accelerometer of an IMD (e.g., a leadless pacemaker) to produce one or more accelerometer outputs indicative of the orientation of the IMD. The method can also include the IMD using an accelerometer to identify when the orientation of the IMD is such that the IMD will likely be able to successfully communicate with another IMD via one or more communication pulses sent from the IMD to the other IMD. The method also includes the IMD sending of the one or more communication pulses, that are used to communicate with the other IMD, when the orientation of the IMD is such that the IMD will likely be able to successfully communicate with the other IMD via one or more communication pulses sent from the IMD to the other IMD.

Enhanced implant-to-implant communications using accelerometer

Implantable medical devices (IMDs), systems, and methods for use therewith are disclosed. One such method is for use by a leadless pacemaker (LP) configured to perform conductive communication with another implantable medical device (IMD). The method includes the LP storing information that specifies when, within a cardiac cycle, the LP and the other IMD implanted in a patient are likely oriented relative to one another such that conductive communication therebetween should be successful. The method also includes the LP sensing a signal indicative of cardiac activity of the patient over a plurality of cardiac cycles, and outputting one or more conductive communication pulses, during a portion of at least one of the cardiac cycles, wherein the portion of the at least one of the cardiac cycles is identified based on the signal that is sensed and the information that is stored.

Enhanced implant-to-implant communications

Described herein are methods, devices, and systems for providing an implantable leadless pacemaker (LP) with a remote follow-up capability whereby the LP can provide diagnostic information to an external device that is incapable of programming the LP, wherein the LP includes two or more implantable electrodes used to output both pacing pulses and conductive communication pulses. Such a method can include the LP monitoring for a presence of one or more notification conditions associated with the LP and/or associated with a patient within which the LP is implanted, and the LP periodically outputting an advertisement sequence of pulses, using at least implantable electrodes of the LP, irrespective of whether the LP recognizes the presence of at least one notification condition. The method can also include the LP recognizing the presence of at least one notification condition, and based thereon, the LP also outputting a notification sequence of pulses.

Remote follow-up methods, systems, and devices for leadless pacemaker systems

An implantable system includes a first leadless pacemaker (LP1) implanted in or on a first chamber of a heart and a second leadless pacemaker (LP2) implanted in or on a second chamber of the heart. The LP1 is configured to time delivery of one or more pacing pulses delivered to the first chamber of the heart based on timing of cardiac activity associated with the second chamber of the heart detected by the LP1 itself. The LP1 is also configured to transmit implant-to-implant (i2i) messages to the LP2. The LP2 is configured to time delivery of one or more pacing pulses delivered to the second chamber of the heart based on timing of cardiac activity associated with the second chamber of the heart as determined based on one or more i2i messages received by the LP2 from the LP1.

Systems and methods for performing pacing using multiple leadless pacemakers

Embodiments described herein relate to implantable medical devices (IMDs) and methods for use therewith. Such a method includes, during each of a plurality of message alert periods during which a communication capability of the IMD is enabled, determining whether a valid message is detected. In response to determining that no valid message was detected during a message alert period, the communication capability of the IMD is temporarily disable for a disable period. A length of the disable period may be increased in response to no valid message being detected during two consecutive message alert periods. A length of the disable period may be dependent on an operational mode of the IMD, such that the length of the disable period differs for different operational modes. The IMD may also enter a noise state, and remain in the noise state until the IMD receives a specified number of valid messages.

Managing communication interference in leadless dual-chamber pacing systems and other IMD systems

Certain embodiments of the present technology disclosed herein relate to implantable systems, and methods for use therewith, that use a temperature sensor to initially detect an onset of patient activity, and then use a motion sensor to confirm or reject the initial detection of the onset of patient activity. Other embodiments of the present technology disclosed herein relate to implantable systems, and methods for use therewith, that use a motion sensor to initially detect an onset of patient activity, and then use a temperature sensor to confirm or reject the initial detection of the onset of patient activity. The use of both a motion sensor and a temperature sensor provides improvements over using just one of the types of sensors for rate responsive pacing.

Pacemaker systems and methods using multiple sensors for rate response pacing

Growing community of inventors

Scotts Valley, CA, United States of America

Matthew G Fishler