Pacesetter, Inc.

Keith Victorine

Steven Roger Conger

Sean Matthew Desmond

Dorab N Sethna

Greg Kampa

Gene A Bornzin

Daniel Ephraim

Xiaoyi Min

Kyungmoo Ryu

Tyler J Strang

Wesley Alleman

Stuart Rosenberg

Nicole Cooper

Alexander Farr

Zoltan Somogyi

Thomas Blake Eby

Michael Childers

Ekaterina Tkatchouk

Kyle J Nix

Devan Hughes

Matthew Nojoomi

Joseph Hansen

John W Poore

Matthew G Fishler

Armando M Cappa

Bernhard Arnar

Sergey Safarevich

Scott Salys

Xiangqun Chen

Avi Fischer

Bei Ning Zhang

Nalin S Perera

Shubha Asopa

Li Jin

Steve Chantasirivisal

Traci Chang

Hanson Chang

Enzo Silipo

Xiangqun Shawn Chen

Christian Medina

Tylerj Strang

A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes a burrowing nose to allow the biostimulator to embed within a target tissue. The embedded biostimulator has a reduced exposed length within a heart chamber, and is less likely to interfere with adjacent heart structures. Embodiments include burrowing ridges on a nose or a housing of the biostimulator to affix the embedded biostimulator to the target tissue. Other embodiments are also described and claimed.

Biostimulator having burrowing nose

A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes an articulation to allow an electrode axis of a pacing electrode to be directed differently than a housing axis of a housing. The housing contains electrical circuitry that is electrically connected to the pacing electrode. The differently directed axes allow the pacing electrode to affix to target tissue of an interventricular septal wall of a heart when the housing of the biostimulator is located near an apex of the heart. The articulation can include a flexible portion of an extension, a hinge, or a tether. Other embodiments are also described and claimed.

Biostimulator having articulation

A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.

Header assembly having threadless interconnection

A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Implantation medical device with multiple parasternal-anterior electrodes

An implantable medical device includes an electrode and an insulative material secured to the electrode via an adhesive. The electrode includes a metal substrate and a metal coating. The metal substrate includes a connection segment and an active segment along a length of the metal substrate. The metal coating is disposed on an outer surface of the metal substrate along the connection segment and the active segment. The insulative material surrounds the connection segment of the metal substrate without surrounding the active segment, and the adhesive adheres to the metal coating on the connection segment.

Implantable medical device and electrode thereof

A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

Biostimulator having coaxial fixation elements

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.

Biostimulator having low-polarization electrode(s)

Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Screw-in pericardial leads and systems for delivering screw-in pericardial leads

Subcutaneous implantation medical device with multiple parasternal-anterior electrodes

A biostimulator, such as a leadless pacemaker, has electrode(s) coated with low-polarization coating(s). 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.

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.

Single-site implantation methods for medical devices having multiple leads

Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Growing community of inventors

Santa Clarita, CA, United States of America

Keith Victorine