Cardiac Pacemakers, Inc.

Other

Curtis Charles Lindstrom

Adam W Cates

Darrell Orvin Wagner

Ron Heil

John E Heil

Avram Scheiner

Ronald W Heil, Jr

William Hsu

Yayun Lin

Peter T Kelley

Jeffrey T Bartig

Robert S Booker, Iii

Qingsheng Zhu

Gerrard Merrill Carlson

Jay A Warren

Jason Alan Shiroff

David M Flynn

Mary Lee Cole

Randall M Peterfeso

Carol Werlein

Aaron W Janke

Gary W Goebel

Douglas A Heitkamp

Paul Allan Haefner

Stuart R Chastain

Gwen Crevensten

James D Kadera

Pete Kelley

An apparatus and method facilitating removal, from a body, of an implanted elongated structure with a lumen such as a lead or catheter, comprises a plurality of wire stylets that are inserted together into the lumen and subsequently moved relative to each other in a longitudinal direction by manipulation at the proximal end. The stylets have dimensional features on their adjacent sides that mate together to minimize the overall diameter of the stylet assembly during insertion into the lumen. Interaction of the features on the stylets' adjacent sides, resulting from the subsequent relative displacement, causes the assembly to expand radially. The expansion is sufficient to engage the luminal surface of the implanted structure, thereby allowing traction forces to be applied, while minimizing deformation of the implanted structure. If repositioning of the apparatus is necessary, the stylets may be returned to initial relative positions, reestablishing a minimal overall diameter.

Apparatus and method facilitating removal of a structure implanted in a body

An implantable subcutaneous device includes a lead and electrode for cardiac monitoring and intervention. The device has an implantable lead including a lead body, a subcutaneous electrode supported by the lead body and a pharmacological agent impelled from the device using phoresis. The pharmacological agent provides a therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent and using phoresis to impel the pharmacological agent into subcutaneous non-intrathoracic tissue surrounding the lead.

Subcutaneous electrode and lead with phoresis based pharmacological agent delivery

An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.

Subcutaneous electrode and lead with temporary pharmacological agents

Subcutaneous leads that incorporate active fixation elements including, for example, helical coils, provide for fixation of cardiac lead components within a patient. An implantable lead includes a lead body with a supported electrode configured for subcutaneous non-intrathoracic placement within a patient. A fixation element is provided on the implantable lead and configured to actively secure one or both of the subcutaneous electrode and the lead body in tissue. A delivery apparatus comprising a sheath may be employed that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location. Lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead supporting an electrode, advancing the lead through the sheath, actively fixing the lead to tissue, and thereafter removing the sheath from the patient.

Helical fixation elements for subcutaneous electrodes

Implantable subcutaneous devices and methods employ a lead and/or electrode for cardiac monitoring and/or intervention. The devices and methods may employ one or more fixation elements including, for example, tines, tines with barbs, spring-loaded tines, flexible or collapsible tines, and other tined fixation mechanisms configured to passively secure one or both of the electrode or body of the lead in subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads according to the present invention involves providing a lead comprising a lead body, an electrode, and one or more fixation elements, and passively securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve use of a delivery device, such as a sheath, for lead delivery to a subcutaneous non-intrathoracic implant site.

Subcutaneous lead with tined fixation

Methods and devices of cardiac electrode placement involve locating electrodes on a thorax of a patient. Surface pacing levels are determined relative to a pacing limit. Surface electrode locations are selected or rejected based on the level being within a limit. Electrodes may be relocated to new locations, and new surface pacing levels determined, until a new surface pacing level falls within the pacing limit. Selecting or rejecting electrode locations involves selecting locations suitable for implantation of subcutaneous cardiac electrodes and implanting at the selected locations. An automated method uses an array of surface electrode elements that are scanned for their associated pacing levels, such as by selecting one or more electrode element locations having the lowest pacing levels, which may correspond to locations suitable for implantation of a subcutaneous cardiac electrode and housing, a subcutaneous electrode array, a unitary subcutaneous defibrillation system, or other suitable implantable cardiac device.

Electrode placement determination for subcutaneous cardiac monitoring and therapy

Subcutaneous systems and leads may be fixed in tissue after placement by use of one or more expanding fixation elements. An expanding fixation element is provided on an implantable lead and configured to secure one or both of a subcutaneous electrode and the lead body within subcutaneous non-intrathoracic tissue. A delivery apparatus comprising a sheath may be included that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient. A method of lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead comprising a lead body and an electrode, and advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location. The method further involves fixing the lead to subcutaneous non-intrathoracic tissue using an expanding fixation element and thereafter removing the sheath from the patient.

Expandable fixation elements for subcutaneous electrodes

A tool for protecting a cardiac stimulating lead from damage upon passing through a hemostasis valve of a vascular introducer in the course of an implantation procedure comprises a splittable, peal-away sheath that is rendered sufficiently rigid by a tool dilator or placement of the lead body within the sheath so that the combination can be forced through a self-closing aperture formed through the hemostatic valve member. The use of the tubular sheath in breaching the self-closing aperture shields the lead electrodes and any covering that may be present from becoming distorted as well as from contamination by silicon oil commonly found in vascular introducers having a hemostasis valve.

Lead insertion tool for hemostatic introducer system

Systems and methods of verifying that implantable cardiac devices operate as intended in a particular patient involve one or more of determining proper placement of system components, determining stimulus levels useful for individual patient stratification, and determining stimulus levels that indicate efficacy of devices, implantable within a given patient. A pacing stimulus set at a surface pacing level is delivered to a patient's heart using surface electrodes. The patient is determined to not be a candidate for implantation of a subcutaneous defibrillation system if the surface pacing level needed to capture the heart exceeds a predetermined level. The patient may be determined to be a candidate for implantation of a subcutaneous system if the surface pacing level needed to effect capture is within an acceptance level. Such determinations are preferably based on a proportionality relationship between a subcutaneous defibrillation level and a surface pacing level.

Patient stratification for implantable subcutaneous cardiac monitoring and therapy

Single pass lead system

A cardiac lead designed for implantation in the vasculature of the left side of the heart comprising a flexible lead body having a central lumen, a removable terminal pin, electrodes electrically coupled to the removable terminal pin, a mechanism for securing the electrodes in the proper position in the vasculature and a mechanism for sealing the central lumen after implantation to prevent body fluids from invading the lumen. The cardiac lead can be implanted or explanted using either a guidewire, a guide catheter or both.

Low profile, ventricular, transvenous, epicardial defibrillation lead

A single-pass endocardial lead electrode adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity includes a lead body with a circumferential outer surface. The lead includes a first distal end electrode which has a first electrical conducting surface. The lead body also has a second electrode which has a second electrical conducting surface. The second electrode is adapted for positioning and fixation to the wall of the atrium of the heart. A passive fixation element may be used as part of the second electrode. The lead body also includes a curved portion which facilitates the positioning and passive fixation of the second electrode.

Single pass defibrillation/pacing lead with passively attached electrode for pacing and sensing

A single-pass endocardial lead electrode adapted for implantation in, on or about the heart and for connection to a system for monitoring or stimulating cardiac activity includes a lead body which is adapted for implantation within a single chamber of the heart, or multiple chambers of the heart. The lead includes a first distal end electrode which has a first electrical conducting surface. The lead body also has a second electrode which has a second electrical conducting surface. The first and second electrodes are either passively or actively attached to the wall of the heart. The lead body also includes a curved portion which facilitates the positioning of the second electrode. The main lead body alternatively includes a recess into which an atrial lead body and an active fixation element attached to one end can travel from a recessed position to a position for fixation to the wall of the heart. The active fixation element can also be moved by turning the terminal pin. The lead body can also include multiple legs, each leg carrying an electrode. The lead is attached to a pulse generator for producing pulses to the multiple sites within the heart. A movement assembly for advancing a helix is also included within the legs and comprises an externally threaded collar which engages with an internally threaded housing or housing insert. The lead further includes a helical tip which has high impedance. The electrode has at least one features of the group: the helix having a coating of an insulating material on its surface, the helix having its surface beyond the distal end of the electrode and the distal end of the electrode having a porous conductive surface at a base of the helix, a porous conductive element at a base of the helix, and a porous conductive element at the end of the electrode having an insulating coating cover from 5-95% of the surface of the porous conductive element. The porous element may further provide a guiding mechanism for the helix as it travels out of the electrode for securing the electrode to the heart.

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Roseville, MN, United States of America

Curtis Charles Lindstrom