Abstract: An implantable lead for a medical device includes a lead body having a proximal end and a distal end, an electrical connector coupled to the proximal end of the lead body, an electrode coupled to the distal end of the lead body, and electrically conductive conductor coil extending between the proximal and the distal end of the lead body, the conductor coil wound in a first winding direction under tension. The lead body also includes a plastic ribbon wound around the conductor coil in a second winding direction opposite to the first winding direction without releasing the tension of the conductor coil.

Abstract: An implantable lead includes a distal portion carrying a tissue stimulating electrode, at least a portion of its outer surface being adapted to stimulate cardiac tissue, wherein the electrode is covered by a pliable, electrically conductive sheath. The sheath is made of an electrically conductive material that does not rely on porosity for electrical charge transfer. The sheath is constructed and arranged to minimize or eliminate tissue ingrowth while passing sufficient electrical energy to stimulate the tissue.

Abstract: An electrode lead for implantation into a small heart vessel, especially into a coronary sinus, is provided with an elongated outer insulating lead body (1), having a proximal end (2), a distal end (3) and at least one electrode pole (4) at the distal end (3). At least one electrical conductor unit (6, 6?) leads to said electrode pole (4), each of said electrical conductor units (6, 6?) having a conductor core (7) and a separate insulating sheath (8) surrounding said conductor core (7). A lumen (9) is provided in said insulating lead body (1), being defined by a tubular envelope (10), to accommodate a guide wire means (11). The at least one electrical conductor unit (6, 6?) and the envelope (10) of the lumen (9) are each slidable relative to each other along their longitudinal direction (L) and fixed relative to each other at least in the vicinity of the distal end (3) of the lead body (1).

Abstract: For treatment of cardiac tissue of a heart of a patient with therapeutic light using an implantable medical device connectable to at least one medical lead carrying electrodes and at least one fixation element that fixes the lead at a fixation area of the cardiac tissue, therapeutic light is emitted toward the at least one fixation area of cardiac tissue and/or toward a contact area between the at least one electrode and cardiac tissue using an intracorporeal light emitter.

Abstract: A lead assembly includes an elongate body having a conductor electrically coupled with an electrode coupled to the elongate body. The lead assembly includes a push tube extending along at least a portion of the elongate body. A distal tip is coupled to the elongate body substantially adjacent to the distal end of the elongate body. The distal tip is sized and shaped to couple with a push tube distal end. In one option, the distal tip includes a seat to receive the push tube distal end. In another option, the seat is a side rail seat and a guide wire extends along the elongate body and is slidably coupled with the side rail seat. The lead assembly includes, optionally, an active fixation device slidably coupled with a portion of the elongate body, and the active fixation device is sized and shaped to couple with the push tube.

Abstract: A lead for sensing and pacing a left ventricle of the heart includes a lead body having a proximal portion and a distal portion, a lumen extending through the lead body, a conductor extending through the lead body from the proximal end to the distal end and an electrode disposed on the distal portion of the lead body and electrically coupled to the conductor. A distal tip of the lead body is continuously deflectable upon advancement and withdrawal of a stylet through the lumen at the distal portion to access a selected branch of the coronary sinus. The distal tip of the lead body may be offset before or after continuously deflecting the distal tip.

Abstract: An intravenous pacemaker electrode comprises an electrode cable featuring a conductor, a duct and an insulating sleeve as well as an electrode head attached to the distal end of the conductor in order to transmit stimulation pulses, with an OCT catheter being moveable in the duct, and comprising a thread-like guide element as well as an OCT measurement element attached to its distal end.

Abstract: A medical electrical lead employs a load bearing sleeve arrangement. A medical electrical lead includes an outer sleeve, having proximal and distal ends, and is formed of a first material. At least one electrical conductor is situated within the outer sleeve and extends between the proximal and distal ends of the outer sleeve. At least one electrode is electrically coupled to the electrical conductor. A load bearing sleeve extends between the proximal and distal ends of the outer sleeve. The load bearing sleeve is formed of a second material different from the first material. The load bearing sleeve offers resistance to axial loading forces applied to the lead. The load bearing sleeve can be coextensive with the outer sleeve or extend along at least the majority of the length of the outer sleeve.

Abstract: A highly flexible implantable lead that offers improved flexibility, fatigue life and fatigue and abrasion resistance improved reliability, effective electrode tissue contact with a small diameter and low risk of tissue damage during extraction. In one embodiment the lead is provided with both defibrillation electrodes and pacing/sensing electrodes. For defibrillation/pacing leads, the lead diameter may be as small as six French or smaller. The construction utilizes helically wound conductors. For leads incorporating multiple separate conductors, many of the helically wound conductors are arranged in a multi-filar relationship. Preferably, each conductor is a length of wire that is uninsulated at about the middle of its length to create an electrode, wherein the conductor is folded in half at about the middle of the length to create first and second length segments that constitute parallel conductors.

Abstract: A method of inserting a pacing lead having a preformed shape into a coronary sinus to pace the left atrium includes providing a lead having an elongated body and proximal and tip sections. The sections are configured such that a first angle less than 90 degrees is defined between the lead body and proximal section and a second angle is defined between the tip and proximal sections. The method further comprises advancing the pacing wire towards the opening of the coronary sinus and advancing the wire into the coronary sinus, such that the first angle is compressed by the coronary sinus opening and a tip electrode included on the tip section contacts the wall of the coronary sinus near the left atrium operably extending the second angle to assure constant contact between the wall of the coronary sinus and the tip electrode.

Abstract: Method and apparatus for treating conductive irregularities in the heart, particularly atrial fibrillation and accessory path arrythmias. An ablative catheter is positioned relative to an inter-atrial electrical pathway, or a vicinity of accessory paths such as the coronary sinus or fossa ovalis, and actuated to form a lesion that partially or completely blocks electrical conduction in at least one direction along the pathway.

Abstract: A catheter used to deliver a medical electrical lead to a right atrium of a heart in close proximity to a His bundle. The catheter is adapted such that the distal tip confronts the His bundle generally perpendicularly. The catheter includes a proximal portion and a generally hook-shaped distal portion. The distal portion may include curves that direct the distal tip at an angle of over 180 degrees from the direction of the proximal portion.

Abstract: Medical electrical leads are provided including fixation features for acute and chronic fixation of a portion of the respective leads within the cardiac venous system. The medical electrical lead includes an elongate body having proximal and distal regions. Tissue contacting portions are selectively located in the distal region to contact an inner surface of the cardiac vessel when the lead is in an implanted position. The tissue contacting portion(s) include fixation features adapted to frictionally engage the inner surface of the cardiac vessel and promote tissue in-growth for chronic fixation. In some embodiments, the fixation features are detachable from the lead such that the lead can be extracted from its implanted position after tissue in-growth occurs.

Abstract: A medical electrical lead includes a coiled electrode. In one example, the coiled electrode includes two conductive filars wound in parallel to define a plurality of turns and a gap between each turn. A polymeric filling is disposed in at least some of the gaps existing between each of the turns. The polymeric filling can include multiple layers of a thin polymeric film or a non-conductive, polymeric filar. The coiled electrode also includes a polymeric covering disposed over the outer surface of the electrode. The polymeric covering is bonded to the polymeric filling disposed in the gaps. The polymeric film includes a non-expanded polymer and the polymeric cover includes an expanded polymer. In some examples the non-expanded polymer is polytetrafluoroethylene (PTFE) and the non-expanded polymer is expanded polytetrafluoroethylene (ePTFE).

Abstract: A medical electrical lead includes a lead body, an inner assembly extending through the lead body, an outer insulative layer covering the inner assembly, and an electrode mounted outside the exterior surface of the outer insulative layer. The inner assembly includes an elongate inner structure forming a lumen, an elongate conductor extending along an outer surface of the inner structure, and a conductive fitting coupled to the elongate conductor.

Abstract: A valvuloplasty system comprises a balloon adapted to be placed adjacent leaflets of a valve. The balloon is inflatable with a liquid. The system further includes a shock wave generator within the balloon that produces shock waves. The shock waves propagate through the liquid and impinge upon the valve to decalcify and open the valve.

Abstract: This document discusses, among other things, a lead assembly including a porous polyethylene cover. In an example, the cover includes sections that have differing pore sizes. In an example, a section of the cover near a distal end portion of a lead assembly includes pores that are large enough to allow tissue ingrowth. In another example, a lead assembly includes two or more polyethylene covers having different porosities.

Abstract: Steerable electrophysiology catheters for use in mapping and/or ablation of accessory pathways in myocardial tissue of the heart wall and methods of use thereof are disclosed. The catheter comprises a catheter body and handle, the catheter body having a proximal section and a distal section and manipulators that enable the deflection of a distal segment of the distal tip section with respect to the independently formed curvature of a proximal segment of the distal tip section through a bending or knuckle motion of an intermediate segment between the proximal and distal segments. A wide angular range of deflection within a very small curve or bend radius in the intermediate segment is obtained. At least one distal tip electrode is preferably confined to the distal segment which can have a straight axis extending distally from the intermediate segment. The curvature of the proximal segment and the bending angle of the intermediate segment are independently selectable.

Abstract: An implantable medical device includes a housing and a circuit board provided within the housing. The circuit board includes a plurality of electronic components electrically coupled thereto. At least one non-functional component is provided on the circuit board and formed from a material that has an electromagnetic permeability configured to reduce the amount of image distortion caused by at least one of the plurality of electronic components when the device is subject to a magnetic field during an MRI scan.

Abstract: A device for ablating tissue includes an elongate body, which may be flexible to wrap about a cardiac structure, and at least one movable ablation element coupled to the body. The movable ablation element is adjustable relative to the body to form an angle with a longitudinal axis thereof between about zero degrees and about 180 degrees. The movable ablation element may be a two element array, and a pivot pin may depend from an underside thereof to pivotably connect the array to the body via a mating pivot hole in the body. The body may be formable into both a substantially flat configuration and a generally curved configuration. In other embodiments, the body is wand-shaped. The device may further include at least one non-movable ablation element coupled to the body and forming an angle of about zero degrees with the longitudinal axis of the body.

Abstract: A lead for connecting to a pacing and/or defibrillation power source is disclosed herein. The lead includes a lead tubular body, a connector for connecting the lead to the power source, and a strain-flex relief assembly joining the lead tubular body to the connector assembly and including a helical multi-strand cable conductor configuration.

Abstract: A lead of the present invention comprises an electrode array adapted to be stably anchored at a selected location within the vena cava of a human patient. The electrode array may take various shapes, including helical, annular and linear. The electrode array is connectable to an electrical stimulation means such as an implantable pulse or signal generator. Electrical stimulation applied to a selected region of the vena cava and across the wall of the vein, that is, transvascularly, to the vagus nerve or branches thereof, depolarizes the nerve to thereby effect control of the heart rate.

Abstract: Methods of implanting a two-part cardiac lead in a heart are disclosed. The two-part cardiac lead has inner and outer portions and a pin. The inner and outer lead portions are separately advanced to a location of interest within the vasculature of a patient. The pin is attached to a proximal end of the inner lead portion and can provide a connection between the inner and outer lead portions.

Abstract: A reinforced medical electrical lead for neurological applications has a reinforced construction for resisting the detachment of electrodes and lead connection terminals, thereby improving the robustness of the lead and extending the life of the lead by reducing the likelihood that a further surgical procedure will be required to remove the lead for repair or replacement thereof. The present reinforced lead construction maintains the integrity of the electrical connection between the conductor and the respective electrode and lead connection terminal by incorporating several reinforcing features in the lead construction in contrast to conventional lead constructions where it is possible to pull the electrodes and lead connection terminals away from their contact points with relatively little force.

Abstract: A lead having pre-formed biased portion is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and are biased toward a vessel wall by the preformed biased portion, which operates to fixate the lead against the vessel wall.

Abstract: Probes that are sensitive to electrode/tissue contact and that are configured to connect an electrode to a power supply and/or provide an indication when the desired level of electrode/tissue contact has been achieved.

Abstract: A modular catheter assembly (10) includes a holder (12) having a proximal end (14) and a distal end (16). An electrode sheath carrier (20) is mounted on the distal end (16) of the holder (12). A shape imparting element carrier is removably mountable to an end of the holder (12) and is accessible externally of the holder (12) with at least the shape imparting element carrier being replaceably mounted to the holder (12).

Abstract: An implantable lead which has an increased resistance to fracture and has the capability of continued function after fracture of a conductor. The lead is provided with a coiled conductor which may be monofilar or multifilar and which extends along the length of the lead, running from an electrical connector at the proximal end of the lead to an electrode at or near the distal end of the lead. In addition, the lead is provided with a stranded conductor which is electrically coupled to the coiled conductor at point along the lead body located proximal to the point of expected breakage of the coiled conductor and at a point along the lead body located distal to the point of expected breakage. The proximal and distal ends of the stranded conductor in some embodiments are also mechanically coupled to the coiled conductor.

Abstract: A method and apparatus for positioning a lead within an anatomy is disclosed. The apparatus can be tracked relative to the anatomy to determine the position of selected portions of the anatomy. The positions of the portions of the anatomy can be used in determining an appropriate lead length to be positioned within the anatomy. Additionally, a determination of a lead length can be based upon statistical or acquired data of a selected population, according to an appropriate method.

Abstract: A guiding catheter system employs a compliant shaft with an inflatable balloon affixed to a distal portion of the shaft. The inflatable balloon includes channels that allow some amount of blood to flow past the balloon when inflated in a blood vessel. One or more inflation lumens is in fluid contact with the balloon and allows inflating the balloon from a proximal end of the catheter. A series of perfusion orifices may be included on the shaft proximal to the balloon.

Abstract: Apparatus and methods are disclosed for inserting electrical leads within a heart. A method is provided for positioning a medical electrical lead in a cardiac vein. The method comprises inserting a lead within a coronary sinus, dispersing at least one vasodilating agent to dilate at least one cardiac vein, and inserting the lead into a dilated cardiac vein.

Abstract: A seal adapted for use with medical devices is provided. The medical device may be a lead having a distal tip adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead assembly in one embodiment includes an atraumatic tip. A seal is provided within the lead tip assembly, which prevents or limits further entry of fluids through the lead tip. The lead may be a left ventricular lead with a hemostasis mechanism provided therewithin.

Abstract: The invention provides an apparatus for cutting an endocardial lead within a patient. The apparatus includes a tubular member and a tension member disposed therein. The tension member includes a distal end and a proximal end. A blade is affixed to the distal end of the tension member and an adjustment mechanism is adapted to adjust the tension member and blade between an extended position and a retracted position. The adjustment mechanism includes a female member, a male member and an anchor. The anchor is affixed to the proximal end of the tension member and the male member. Insertion and withdrawal of the male member within the female member moves the tension member and the blade between the extended position and the retracted position. An alternate embodiment includes a capture mechanism or guide wire for drawing the apparatus and lead closer together before extending the blade and cutting the lead.

Abstract: This document discusses, among other things, a lead assembly including a porous polyethylene cover. In an example, the cover includes sections that have differing pore sizes. In an example, a section of the cover near a distal end portion of a lead assembly includes pores that are large enough to allow tissue ingrowth. In another example, a lead assembly includes two or more polyethylene covers having different porosities.

Abstract: An implantable line, in particular an electrode line and/or sensor line and/or medicine supply line for implantation in the left ventricle of the heart with perforation of the atrial or ventricular septum, includes an elongated flexible line body, an electrode and/or a sensor and/or a medicine administering device at or near the distal end of the line body, and a closure element integrally molded on the line body or connected thereto for sealing the perforation site in the septum.

Abstract: Disclosed herein is an implantable medical lead. In one embodiment, the lead includes a tubular body, a sensor module, and a distal crimp sleeve. The tubular body includes a distal end and a proximal end. The sensor module includes a sensor and a housing enclosing the sensor. The housing is operably coupled to the tubular body and includes a distal end cap. The distal crimp sleeve is operably coupled to the distal end cap and extends proximally therefrom. The longitudinal axis of the distal crimp sleeve is generally parallel to a longitudinal axis of the housing.

Abstract: A cardiac lead system includes a cardiac lead having a lumen, and a guide member displaceable within the lumen. The guide member includes a guide wire extension that extends distal to the elongated body of the guide member. The guide wire extension is dimensioned to pass through an external distal opening of the cardiac lead lumen. Engagement of stop features or a stop mechanism of the cardiac lead system provides a push point for advancing the cardiac lead system through the patient's anatomy.

Abstract: A catheter used to deliver a medical electrical lead to a right atrium of a heart in close proximity to a His bundle. The catheter includes a proximal portion and a distal portion.

Abstract: Preformed guiding stylet for introducing a septal lead in contact with the septum or other intra-corporal device in contact with body tissue. This stylet include a flexible wire (10), to be introduced by its distal end in a central lumen of the lead, and a control handle (18). The wire is elastically deformable in bending and has sufficient rigidity in torsion to enable transmission by the handle rotation of a rotational movement over the entire length of the wire. In the unstressed status, the wire comprises successively in its distal part (12), a first curvilinear portion (C1), a first straight portion (D1), a second curvilinear portion (C2) and optionally a second straight portion (D2). The first and second curvilinear portions extend in respective planes (P1, P2) making an angle (?3) between them defining a dihedral (?) which axis (?) comprises the first straight portion (D1).

Abstract: Various different implementations of lead systems are disclosed for use with implantable stimulation systems. Generally, the lead systems incorporate, within an elongate lead body, one or more electrical conduits that connect to one or more distal electrodes, and a liquid-filled pressure transmission catheter lumen that extends proximally from a distal entry port. Use of the lead systems allows accurate pressure sensing at a location near where the electrodes are positioned. In addition, a defibrillator lead is disclosed having such features, and a system using that lead is capable of directly monitoring pressure within a heart chamber, and using that information to confirm the delivery of a defibrillation pulse.

Abstract: A lead delivery apparatus includes an electrically conductive lead for an implantable medical device, a delivery shaft for delivering the lead to a target site, a fixator and a pulley structure. A flexible member is coupled to the delivery shaft and the lead and engages the pulley structure such that pulling a first portion of the flexible member moves the lead to the target site.

Abstract: A medical apparatus includes an electrically conductive lead for a medical device, the lead having an internal bore terminating at a distal lead opening, and a lead delivery device for delivering the distal end of the lead to a blood vessel during implantation of the lead. The lead delivery device includes a removably anchorable guidewire, and a fixator attached to a distal portion of the guidewire for anchoring the guidewire. The fixator is movable between a compact configuration and an expanded configuration. The fixator is capable of passing through the distal lead opening of the lead in the compact configuration. The fixator is capable of exerting a holding force in the range of about 0.89 to 4.45 N in the lumen of the blood vessel in the expanded configuration.

Abstract: Cardioprotective pacing is applied to prevent and/or reduce cardiac injury associated with myocardial infarction (MI) and revascularization procedure. Pacing pulses are generated from a pacemaker and delivered through one or more pacing electrodes incorporated onto one or more percutaneous transluminal vascular intervention (PTVI) devices during the revascularization procedure. In one embodiment, at least one pacing electrode is incorporated onto the shaft of a PTVI device to allow the pacing pulses to be delivered to a site remote from an infarcted region where the distal end portion of the PTVI device is placed.

Abstract: An implantable medical device that includes a lead body extending from a proximal end to a distal end, a plurality of conductors extending between the proximal end and the distal end of the lead body, and an insulative layer formed of a hydrolytically stable polyimide material surrounding the plurality of conductors. In one embodiment, the hydrolytically stable polyimide material is an Si polyimide material.

Abstract: A system and method for estimating a hemodynamic performance parameter value of a patient's heart. The system includes a pulse generator and a medical electrical lead implanted partially within a coronary vein of the heart. The lead includes at least one sensor located within the coronary vein configured to generate a signal indicative of at least one dimensional parameter of the coronary vein. Changes in the dimensional parameter during one or more cardiac cycles are measured. The hemodynamic performance parameter is estimated based on the change in the dimensional parameter of the coronary vein.

Abstract: The invention describes a steerable sheath for percutaneous epicardial access. The invention also describes a novel lead to facilitate left ventricular pacing and efficient defibrillation.

Abstract: A position of an imaging plane relative to a catheter or other probe is aligned with tissue of interest. Ultrasound tissue images may be registered to the catheter position with minimal rotational ambiguity. The spatial position of an ablation catheter or other device with respect to the imaging plane is more accurately determined, allowing a physician to identify specific anatomy in the relative location of a catheter or catheters. Another alternative or additional approach to determining the position of an imaging plane is to determine the relative position of two or more catheters. A catheter associated with imaging is then moved or bent in a direction having a known spatial relationship with the imaging plane. The position of the catheter is relative to each is then determined again to determine the angle or position of the imaging plane.

Abstract: Defibrillator lead designs and methods for manufacturing a lead having attachment between a fibrosis-limiting material covering, a shocking coil electrode, and an implantable lead body are disclosed herein. An electrode coil fitting is disposed within the shocking coil electrode. In an option, the fibrosis limiting material extends past the ends of the electrode coil, and is wrapped between the coil electrode and the electrode coil member.

Abstract: An implantable cardioverter defibrillator (ICD) including a set of leads having electrodes disposed therein. The electrodes may include a weld electrode connected to an internal wire of the lead and the ICD and a tip electrode. The tip electrode may have a set of grooves or cut out regions in its outer surface to provide edge effects for currents applied through the tip electrode. The grooves or cut out regions may form gaps in the surface of the tip electrode exposing a medical compound that is housed within the tip electrode. The medical compound may elute through the gaps.

Abstract: A system for mapping electrical activity of a patient's heart includes a set of electrodes spaced from the heart wall and a set of electrodes in contact with the heart wall. Voltage measurements from the electrodes are used to generate three-dimensional and two-dimensional maps of the electrical activity of the heart.