Pacesetter, Inc.

Christopher R Jenney

Sheldon Williams

Kevin L Morgan

Gene A Bornzin

Anne Margaret Pianca

Dino Bortolin

Asghar Dadashian

John R Helland

Thomas Blake Eby

Craig E Mar

Phong D Doan

Paul M Paspa

Ofer Rosenzweig

Kerwyn Schimke

Avi Bilu

Ekaterina Tkatchouk

An implantable medical device includes a header body and a septum assembly. The header body includes a first welding surface and a septum bore extending inwardly from an outer surface to an inner cavity. The septum assembly is at least partially disposed within the septum bore of the header assembly and includes a septum configured to allow insertion of a tool through the septum into the inner cavity and to otherwise provide a seal. The septum assembly further includes a retainer within which at least a portion of the septum is retained. The retainer includes a welding feature coupled to the retainer body, the welding feature providing a second welding surface. The retainer is coupled to the header body by welding the first welding surface to the second welding surface.

Implantable medical device including welded septum assemblies

Delivery of implantable active agent delivery components includes implanting a distal lead end of a lead into tissue at an implantation site. A delivery stylet is then inserted through a lead lumen of the lead. The delivery stylet includes a stylet body having a distal stylet end and an active agent delivery component detachably coupled to the distal stylet end. The active agent delivery component is inserted into the tissue at the implantation site by extending the distal stylet end of the delivery stylet from a distal lead end of the lead such that the active agent delivery component is inserted into the tissue at the implantation site. The active agent delivery component is then detached within the tissue at the implantation site and the delivery stylet may be retracted and removed from the lead lumen.

Device, system, and method for delivery of an implantable cardiac lead and associated active agent delivery component

A leafless biostimulator, such as a leadless pacemaker, includes a housing sized and configured to be implanted within a heart of a patient and includes both primary and secondary fixation features. The primary fixation feature is adapted to rotate to fix the leadless biostimulator to a wall of the heart during initial implantation. Once the leadless biostimulator is implanted, the secondary fixation feature is adapted to resist counter-rotation of the leadless biostimulator. The primary fixation feature may include a fixation helix configured to affix the housing to the heart by rotating in a screwing direction. The secondary fixation feature may include an apex to engage the heart to resist unscrewing of the primary fixation feature.

Fixation mechanisms for a leadless cardiac biostimulator

Disclosed herein is an implantable electronic device. The device has a housing and a header connector assembly coupled to the housing. The header connector assembly has a connector assembly and a header enclosing the connector assembly. The connector assembly has a subassembly including an electrically conductive component at least partially residing within a first material that is provided about the electrically conductive component. The header has a second material that is provided about the connector assembly and the subassembly subsequent to the first material setting up about the electrically conductive component.

Implantable electronic device employing fused thermoplastic-conductor subassembly and method of manufacturing the subassembly and the device

Implementations of the present disclosure may take the form of an implantable electronic device such as an implantable pulse generator for administering electrotherapy via an implantable medical lead configured to couple with the implantable pulse generator, or an implantable cardiac monitor. The implantable electronic device includes a housing, a header connector assembly and a sealing member. The header connector assembly includes a connector assembly and a header enclosing the connector assembly. The sealing member is sandwiched between the header connector assembly and the housing.

Systems and methods for attaching pre-fabricated header connector assembly to housing of implantable electronic device

A body implantable lead includes a lead body comprising an insulative housing containing at least one conductive polymer conductor terminating within a distal end portion of the lead body at an electrode structure carried by the distal end portion of the lead body. The electrode structure is positioned to contact body tissue to be electrically stimulated and/or sensed. The electrode structure electrically communicates with the at least one conductive polymer conductor by means of an electrically conductive interconnect penetrating the at least one conductive polymer conductor. The at least one conductive polymer conductor terminates within a proximal end portion of the lead body at a terminal contact adapted to be electrically connected to an electrically stimulating/sensing medical device. Also disclosed are connector assembly, tip electrode and ring electrode structures adapted to be coupled to an implantable lead body containing a conductive polymer conductor.

Body implantable lead comprising electrically conductive polymer conductors

A body implantable lead comprises a lead body including a conductive polymer electrode disposed along a distal end portion of the lead body for performing one or more of the functions consisting of pacing, sensing, cardioversion and defibrillation. An electrical conductor, preferably in the form of a multistrand cable conductor, couples the conductive polymer electrode with a proximal end of the lead body. The conductive polymer electrode encapsulates the conductor and is in electrical contact therewith along the length, and preferably along substantially the entire length, of the conductive polymer electrode. The lead body may comprise a multilumen polymer housing, the conductor being contained within one of the lumens of the housing. The conductive polymer electrode may be disposed within a window formed in the lead body. Alternatively, the conductive polymer electrode may comprise multiple electrode sections within a corresponding number of windows formed in the lead body and spaced apart along the length thereof. Further, the window and the conductive polymer electrode disposed therein may extend helically about the lead body. Because of its flexibility and because it can have a small diameter, the lead of the invention is particularly advantageous for implantation in the small, tortuous vessels of the coronary sinus region of the heart for left side stimulation and/or sensing. Methods of fabricating lead bodies incorporating conductive polymer electrodes are also disclosed.

Body implantable lead including one or more conductive polymer electrodes and methods for fabricating same

An implantable stimulation lead is disclosed for placement in the coronary sinus region and its associated coronary vessels overlying the left side of a patient's heart. The lead comprises at least one proximal connector; at least one tissue stimulation electrode; at least one conductor coupled between the at least one proximal connector and the at least one stimulation electrode; and a lead body including a housing of insulating material enclosing the at least one conductor, the lead body having a relatively flexible distal portion of, for example, silicone rubber, having a length corresponding to the coronary sinus region of the heart, and a stiffer proximal portion of, for example, polyurethane. A robust transition joint comprising telescoped sections of the distal and proximal portions of the lead body couples the two portions of the lead body. Also provided is a versatile lead delivery system including a stylet stop disposed within the distal portion of the lead body. The stylet stop defines an aperture dimensioned to pass a guide wire but not the enlarged distal tip of a stylet. The lead includes a tip electrode having a longitudinally extending bore dimensioned to permit passage of the guide wire through the tip electrode.

Implantable coronary sinus lead and lead system

An implantable lead for electrical stimulation of the body includes an elongated multi-lumen tube with a distal tip electrode having a longitudinally extending central bore. A cable conductor is received in one lumen of the multi-lumen tube for electrical connection to the tip electrode and an elongated polymeric tubular liner having a coefficient of friction in the range of 0.01 to 0.20 is received in another lumen of the multi-lumen tube generally aligned with the bore of the distal tip electrode for freely receiving a guidewire through the tubular liner and through the bore of the distal tip electrode. An electrically conductive proximal pin is attached to the multi-lumen tubing distant from the tip electrode and, in one embodiment, the cable conductor and the proximal end of the polymeric tubular liner are attached to the proximal pin. Initially, the guidewire is implanted into the body along a desired trajectory. With the polymeric tubular liner inserted, first the distal tip electrode, then the remainder of the multi-lumen tube, are slid onto the guidewire such that the guidewire slidably advances within the polymeric tubular liner. Thereupon, the multilumen tube is advanced along the guidewire until a desired site is achieved and the guidewire is removed from the body and the multi-lumen tube. In another embodiment, the distal tip electrode has no central bore but the elongated polymeric tubular liner is axially aligned with the distal tip electrode for freely receiving a stylet which is attached with the distal tip electrode.

Lead with polymeric tubular liner for guidewire and stylet insertion

An implantable lead for electrical stimulation of the body includes an elongated multi-lumen tube with a distal tip electrode having a longitudinally extending central bore. A cable conductor is received in one lumen of the multi-lumen tube for electrical connection to the tip electrode and an elongated polymeric tubular liner having a coefficient of friction in the range of 0.01 to 0.20 is received in another lumen of the multi-lumen tube generally aligned with the bore of the distal tip electrode for freely receiving a guidewire through the tubular liner and through the bore of the distal tip electrode. An electrically conductive proximal pin is attached to the multi-lumen tubing distant from the tip electrode and, in one embodiment, the cable conductor and the proximal end of the polymeric tubular liner are attached to the proximal pin. Initially, the guidewire is implanted into the body along a desired trajectory. With the polymeric tubular liner inserted, first the distal tip electrode, then the remainder of the multi-lumen tube, are slid onto the guidewire such that the guidewire slidably advances within the polymeric tubular liner. Thereupon, the multi-lumen tube is advanced along the guidewire until a desired site is achieved and the guidewire is removed from the body and the multi-lumen tube. In another embodiment, the distal tip electrode has no central bore but the elongated polymeric tubular liner is axially aligned with the distal tip electrode for freely receiving a stylet which is attached with the distal tip electrode.

Growing community of inventors

Valencia, CA, United States of America

Christopher R Jenney