Pacesetter, Inc.

Alex C Soriano

Yelena Nabutovsky

Fujian Qu

Thomas Blake Eby

Wisit Lim

Armando M Cappa

Dan E Gutfinger

Perry Li

Alan B Vogel

Jorge N Amely-Velez

Jeffery Crook

Evan Sheldon

John R Gonzalez

Alexander Robertson

Matthew G Fishler

Paul M Paspa

Carl Lance Boling

Brett C Villavicencio

Riddhi Shah

Thomas Robert Luhrs

Tyler J Strang

Kavous Sahabi

Russell Klehn

Matthew R Malone

Arees Garabed

Ryan Rooke

Wes Alleman

Conor P Foley

Gene A Bornzin

Steve Koh

Andreas Blomqvist

Ofer Rosenzweig

Mark Carlson

Tracee E Eidenschink

Wenbo Hou

Zoltan Somogyi

Reza Shahandeh

Tejpal Singh

Xiangqun Chen

Rodney J Hawkins

Julie Prillinger

Mitch Goodman

Li Jin

Adam Evard

Jake Singer

A blade for a cutting instrument includes a handle, a body, and at least three cutting edges along the body. The body has first and second sides extending along a longitudinal center axis. The body has a proximal end at the handle and a distal tip remote from the handle. The at least three cutting edges are oriented at corresponding angles with respect to the longitudinal center axis and are asymmetrically distributed with respect to the longitudinal center axis.

Cutting instrument with asymmetric blade

Methods for manufacturing implantable electronic devices include forming an antenna of the implantable electronic device by delivering an antenna trace within a dielectric antenna body. The antenna trace includes a first trace portion disposed in a first transverse layer and defining a first trace path and a second trace portion disposed in a second transverse layer longitudinally offset from the first transverse layer and defining a second trace path. If projected to be coplanar, the first trace path defines a trace boundary and the second trace path is within the trace boundary.

Methods of manufacturing an antenna for an implantable electronic device and related implantable electronic devices

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

Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.

Systems and methods for implanting an implantable cardiac monitor

A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.

Biostimulator having resilient scaffold

An electrical feedthrough assembly, which is configured to be mounted on a housing of a leadless biostimulator, comprises an electrode body including a cup having an electrode wall extending distally from an electrode base around an electrode cavity, an electrode tip mounted on a distal end of the electrode body, and a filler in the electrode cavity between the electrode base and the electrode tip, wherein the filler includes a therapeutic agent. The electrode tip is configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A pin extends proximally from the electrode base, wherein the pin is configured to be into contact with an electrical connector of an electronics assembly within the housing of the leadless biostimulator.

A header-less implantable medical device, system and method are provided. The device includes an electronics module including circuitry, a battery, a receptacle assembly having an interior chamber and a receptable inlet configured to receive a lead connector assembly. A device housing has a case body that includes side walls and a peripheral edge that defines a single common chamber. The electronics module, battery and receptacle assembly are provided within the single common chamber. A connector opening is provided in the case body and joined to the receptacle inlet to form a passage through the case body into the interior chamber of the receptacle assembly.

Header-less implantable medical device

A biostimulator, such as a leadless cardiac pacemaker, including an electrical feedthrough assembly mounted on a housing, is described. An electronics compartment of the housing can contain an electronics assembly to generate a pacing impulse, and the electrical feedthrough assembly can include an electrode tip to deliver the pacing impulse to a target tissue. A monolithically formed electrode body can have a pin integrated with a cup. The pin can be electrically connected to the electronics assembly, and the cup can be electrically connected to the electrode tip. Accordingly, the biostimulator can transmit the pacing impulse through the monolithic pin and cup to the target tissue. The cup can hold a filler having a therapeutic agent for delivery to the target tissue and may include retention elements for maintaining the filler at a predetermined location within the cup.

Biostimulator feedthrough having integrated electrode cup

Disclosed herein is an implantable electronic device including a housing containing an electrical circuit. The implantable electronic device further includes an antenna assembly coupled to the electrical circuit. The antenna assembly includes an antenna including a dielectric antenna body within which an antenna trace is disposed. Portions of the antenna trace are disposed in offset transverse layers in a non-overlapping arrangement, thereby reducing capacitive coupling between the layers of the antenna trace. In certain implementations, the antenna assembly includes one or more capacitive features that selectively overlap portions of the antenna trace and facilitate tuning of the antenna.

Systems and methods for an antenna of an implantable electronic device

Disclosed herein is an implantable electronic device having a housing containing an electrical circuit. The implantable electronic device further includes an antenna assembly coupled to the electrical circuit. The antenna assembly has an antenna with a dielectric antenna body within which an antenna trace is disposed. Portions of the antenna trace are disposed in offset transverse layers in a non-overlapping arrangement, thereby reducing capacitive coupling between the layers of the antenna trace. In certain implementations, the antenna assembly has one or more capacitive features that selectively overlap portions of the antenna trace and facilitate tuning of the antenna.

In specific embodiments, a method to monitor left atrial pressure and/or intra-thoracic fluid volume of a patient, comprises (a) monitoring posture of the patient using a posture sensor implanted within the patient, and (b) using portions of an impedance signal, obtained using implanted electrodes, to monitor the left atrial pressure and/or intra-thoracic fluid volume of the patient. Each portion of the impedance signal used to monitor the left atrial pressure and/or intra-thoracic fluid volume of the patient corresponds to a period after which the patient has maintained a predetermined posture for at least a predetermined period of time, and during which the patient has remained in the predetermined posture.

Methods and systems that use implanted posture sensor to monitor left atrial pressure and/or inter-thoracic fluid volume

Techniques are provided for detecting pulmonary congestion based on an increase in right ventricular (RV) stroke volume over left ventricular (LV) stroke volume. In one example, the device generates an index based on accumulated differences between RV stroke volume and LV stroke volume while RV stroke volume exceeds LV stroke volume, such that the index is indicative of an ongoing imbalance between RV and LV stroke volume. The index is compared to a suitable threshold to detect a severe imbalance indicative of pulmonary edema. Additionally, techniques are described for estimating RV and LV stroke volumes based on pulmonary artery pressure, left atrial pressure, aortic pressure, LV strain or on various intracardiac or extracardiac impedance measurements.

System and method for detecting pulmonary congestion based on stroke volume using an implantable medical device

Various techniques are provided for use with an implantable medical device for exploiting near-field impedance/admittance. Examples include techniques for assessing heart chamber disequilibrium, detecting chamber volumes and pressures, calibrating near-field-based left atrial pressure (LAP) estimation procedures and for assessing the recovery from injury at the electrode-tissue interface. In one particular example, the implantable device assesses the degree of concordance between the left ventricle (LV) and the right ventricle (RV) by quantifying a degree of scatter between LV and RV near-field admittance values. An increase in RV admittance is indicative of RV failure, an increase in LV admittance is indicative of LV failure, and an increase in both LV and RV admittance is indicative of biventricular failure.

Systems and methods for exploiting near-field impedance and admittance for use with implantable medical devices

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Ventura, CA, United States of America

Alex C Soriano