Abstract: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.

Abstract: A medical electrical lead includes a lead body and a connector terminal. A conductor extends from the lead body to the connector terminal along a helical path through a transition zone.

Abstract: A cardiac catheter for minimally invasive diagnostic and/or ablation procedures includes an elongated cylindrical, electrically non-conductive exterior tube with surface electrodes disposed on its distal portion and a handle on its proximal end. The distal portion can be curved into a curvature retained by a single action on a manual actuator. An electromechanical drive system may be incorporated into the handle. An electrical heating element may be incorporated within the distal electrode for ablation procedures. A removable, disposable blood contacting segment may be provided. The non-blood contacting actuator is thus reusable. The catheter includes two tension/compression members, which are wires with circular cross-sections that are integrally formed into ribbon-like configurations at their distal portions, for curvature formation.

Abstract: The present invention relates to an anchor device comprising an elongated tubular body having an expandable member disposed on its distal end portion. The invention also relates to a system adapted to position and anchor the distal end of an ablation device at a location where a pulmonary vein extends from the atrium.

Abstract: A cardiac lead comprising a lead body extending from a proximal end portion to a distal end portion; a cardiac electrode disposed along the lead body; and a coating associated with at least a portion of the electrode, the coating comprises a conductive polymer.

Abstract: Low voltage conductors in a lead assembly share a lumen in a tube and are separated from adjacent conductors in the tube by an insulative layer. In an embodiment, low voltage conductors are combined with high voltage conductors. In another embodiment, low voltage conductors are combined with other low voltage conductors.

Abstract: An implantable medical device (IMD) can include implantable pulse generator (IPG) devices, implantable cardioverter-defibrillators (ICD), cardiac resynchronization therapy defibrillator devices, neurostimulators or combinations thereof. In one example, the IMD can include a body assembly, which can provide at least one electrical signal corresponding to a therapy. The IMD can also include a cardiac lead assembly, which can have a proximal portion and a distal portion. The proximal portion of the cardiac lead assembly can be in communication with the body assembly to receive the therapy and the distal portion can be adapted to be coupled to an anatomical structure to transmit the at least one electrical signal to the anatomical structure. The proximal portion of the cardiac lead assembly can have a first stiffness and the distal portion can have a second stiffness. The first stiffness can be greater than the second stiffness.

Abstract: An implantable medical device (IMD) can include implantable pulse generator (IPG) devices, implantable cardioverter-defibrillators (ICD), cardiac resynchronization therapy defibrillator devices, neurostimulators or combinations thereof. The IMD can also include a cardiac lead assembly in communication with the body assembly to transmit the at least one electrical signal to an anatomical structure. The cardiac lead assembly can include a first sleeve, which can have a distal end, a proximal end, and a surface therebetween. The surface can define a plurality of annular ribs along the distal end and can have a channel defined between each pair of adjacent ribs. An electrode can be coupled to the surface of the first sleeve adjacent to the distal end such that at least one channel is fillable with an adhesive to couple a second sleeve to the first sleeve.

Abstract: A lead assembly for placement in a coronary vessel of the heart, the coronary vessel having a pericardial wall portion and a myocardial wall portion. The lead assembly comprises a lead body extending from a proximal end adapted for coupling to a pulse generator to a distal end adapted for implantation in the heart, an electrode positioned at the distal end of the lead body, and a loop biasing feature located at the distal end of the lead body. The loop biasing feature includes a resilient loop positioned to bias a portion of the electrode towards the myocardial wall portion of the coronary vessel by exerting a force against the pericardial wall portion. The loop biasing feature further includes a collar for coupling the loop biasing feature to the lead body. A method of implanting the lead assembly.

Abstract: This invention relates to a device for intracavity stimulation of the left atrium and/or ventricle from the prepectoral region through a less invasive and lower-risk approach that allows the implantation of an intracavity catheter in the left cardiac chambers through atrial transseptal puncture, and the removal of the catheter proximal end by the retrograde venous route.

Abstract: An electrode arrangement has a stimulation electrode (7) that can be implanted transvenously for the Tawara node (5) allocated to the left ventricle (3) of a human heart (1). In order to not have to feed the stimulation electrode (7) via coronary veins, an element that can be inserted into the right ventricle (2) and that is used for piercing or forming a channel in the tissue of the heart (1) toward the Tawara node (5) of the left ventricle (3) is part of the electrode arrangement, so that the stimulation electrode (7) can be implanted in the region of the Tawara node (5) of the left ventricle (3). The feeding element can be a hollow needle (8) or a first stimulation electrode (6) for the right ventricle (2). The channel can be formed by a stiletto blade (9) or guide wire (10) or the helical coil of the second stimulation electrode (7) itself.

Abstract: A cardiac ablation device, including a catheter and an expandable ablation element incorporating one or more balloons at the distal end of the catheter, has a continuous passageway extending through it from the proximal end of the catheter to the distal side of the expandable ablation element. A probe carrying electrodes is introduced through this passageway and deploys, under the influence of its own resilience, to a structure incorporating a loop which is automatically aligned with the axis of the expandable ablation device, so that minimal manipulation is required to place the probe. The probe may have an atraumatic tip with a ball formed at the leading edge. The atraumatic tip prevents any tissue damage such as perforation of heart wall.

Abstract: The present invention relates generally to multifunctional catheters for performing ablation procedures, and more particularly to ablation catheters utilized in the treatment of atrial fibrillation and other cardiac disorders. The present invention eliminates many of the problems associated with previous ablation catheters by providing an ablation treatment not dependent upon continuous lesions.

Abstract: A steerable multi-linked device. The device includes a first multi-linked mechanism and a second multi-linked mechanism. At least one of the first and second multi-linked mechanisms is steerable and includes a modular link assembly at an end thereof. The modular link assembly includes a base, and a tip removably connected to the base.

Abstract: An implantable intravascular medical device, and methods related to the implantable intravascular device, includes a plurality of containers connected by flex couplers which are configured for implantation in such a manner as to improve vascular response and reduce thrombosis resulting from chronic implantation of the device.

Abstract: What is described is a method of implanting one or more electrodes of a pacing or defibrillation lead in heart tissue. The method comprises positioning a distal end of a catheter against a surface of the heart tissue, extending a distal end of a first electrode from a lumen of the catheter such that the distal end of the first electrode penetrates the surface, and retracting the first electrode to fix a hook feature of the first electrode in the heart tissue.

Abstract: A method and apparatus permit sensing one or more forces exerted by one or more portions of a heart. A force transducer and displacement sensor are disclosed. A movement of one or more portions of a heart can be translated into one or more signals indicative of force. These signals can be used to provide information such as to diagnose or treat one or more conditions.

Abstract: Selective sensing implantable medical leads include pulsing and sensing portions and pulsing and not sensing portion. Leads and electrodes may be used in defibrillation and as integrated bipolar defibrillation electrodes. An entire electrode can pass charge while a valve metal or valve metal oxide portion of the electrode prevents the entire electrode from sensing, effectively rejecting unwanted signals. Differential conduction pathways, due to the valve metal and/or oxides thereof, cause the portions of the electrodes to conduct differently when used anodically and cathodically. Complex intracardiac electrical gradient can be formed along with a number of virtual electrodes within the tissue. Reentrant loops can thereby be pinned following defibrillation shock.

Abstract: Devices and methods for placing medical leads using minimally invasive techniques. One lead includes a lead body connected to a lead head having an aperture for providing fiber optic access to the interior of a helical electrode. The fiber optic shaft may be disposed within or along-side a drive shaft releasably coupled to the head to rotate the head. The drive shaft and lead body may be delivered using a delivery catheter. The delivery catheter can be advanced though a small incision to the target tissue site, and the site remotely visualized through the fiber optic scope extending through the lead head aperture. Some catheters include a distal mapping electrode readable from the catheter proximal portion or handle. The lead head can be rotated, rotating the helical electrode into the tissue, and the catheter, drive shaft, and fiber optic probe removed.

Abstract: A medical electrical trans-septal pacing lead includes a lead body, a tine-like structure terminating a distal end of the lead body and a distal electrode coupled to the lead body at a position proximal to and in close proximity to the structure. A method for delivering left ventricular pacing to a heart includes inserting the trans-septal pacing lead through an inter-ventricular septal wall of the heart, from a right ventricle to a left ventricle, and positioning the distal electrode in a left ventricular endocardial surface of the septal wall.

Abstract: An embodiment includes a main lead assembly having a proximal portion adapted for connection to a device and a distal portion adapted for placement in a coronary sinus, the distal portion terminating in a distal end for placement proximal a left ventricle. Additionally, the main lead assembly includes a left ventricular electrode located at its distal end which is adapted to deliver cardiac resynchronization therapy to reduce ventricular wall stress. The main lead assembly also includes a fat pad electrode disposed along the main lead assembly a distance from the distal end to position the fat pad electrode proximal to at least one parasympathetic ganglia located in a fat pad bounded by an inferior vena cava and a left atrium. The fat pad electrode is adapted to stimulate the parasympathetic ganglia to reduce ventricular wall stress.

Abstract: A method of ablating tissue in the heart to treat atrial fibrillation introduces into a selected atrium an energy emitting element. The method exposes the element to a region of the atrial wall and applies ablating energy to the element to thermally destroy tissue. The method forms a convoluted lesion pattern comprising elongated straight lesions and elongated curvilinear lesions. The lesion pattern directs electrical impulses within the atrial myocardium along a path that activates the atrial myocardium while interrupting reentry circuits that, if not interrupted, would cause fibrillation. The method emulates the surgical maze procedure, but lends itself to catheter-based procedures that do not require open heart surgical techniques. A composite structure for performing the method is formed using a template that displays in planar view a desired lesion pattern for the tissue. An array of spaced apart element is laid on the template.

Abstract: Exemplary lead assemblies include a lead body having a plurality of conductor wires embedded therein, a plurality of electrode contacts at least partially disposed on an outer surface of the lead body, and a plurality of switching networks each configured to control an operation of one or more of the plurality of electrode contacts.

Abstract: A surgical device has an integral first tip having pair of electrodes configured to ablate tissue using electric energy. A second tip has a pair of electrodes configured to provide pacing signals to a heart and/or to sense electrical signals passing through heart tissue. The second tip is configured to snap onto the first tip, such that the same device may be used for ablation, pacing, and sensing. Alternatively, the second tip may be integral with the device and the first tip configured to snap onto the second tip. Alternatively, a single integral tip of the surgical device may be used for ablation, pacing, and sensing. Such a multipurpose tip may comprise a plurality of electrode pairs or an array of electrodes. A user interface on the device or elsewhere may be operable to provide selectable modes for selectively varying properties of signals communicated to the electrodes.

Abstract: A method of mapping electrical activity of a patient's heart. The system 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.

Abstract: An ablating device has a cover which holds an interface material such as a gel. The cover contains the interface material during initial placement of the device. The ablating device may also have a removable tip or a membrane filled with fluid. In still another aspect, the ablating device may be submerged in liquid during operation.

Abstract: A radio frequency antenna is provided for use with a medical device for implantation into an animal. The antenna comprises a coil formed by a wire that includes a core formed of a shape-memory material with an electrically conductive first layer applied to an outer surface of the core. A second layer, of an electrically insulating and biologically compatible material, extends around the first layer. If necessary to reduce friction, a lubricant is placed between the first and second layers. If second layer is formed of a porous material or a non-biological compatible material, a biological compatible outer layer surrounds the second layer thereby providing a barrier that is impermeable to body fluids of the animal.

Abstract: An ablating device has a cover which holds an interface material such as a gel. The cover contains the interface material during initial placement of the device. The ablating device may also have a removable tip or a membrane filled with fluid. In still another aspect, the ablating device may be submerged in liquid during operation.

Abstract: A system and method for creating lesions and assessing their completeness or transmurality. Assessment of transmurality of a lesion is accomplished by monitoring the depolarization signal in a local electrogram taken using electrodes located adjacent the tissue to be ablated. Following onset of application of ablation energy to heart tissue, the local electrogram is measured with electrodes located adjacent tissue to be ablated so that the ablation energy to ablation elements can be selectively reduced or terminated when transmurality is detected.

Abstract: An endocardial mapping system is described to map electric field activity in a heart chamber. The system includes a catheter assembly having an expandable array of electrodes and a plug with each electrode connected to a single connection in the plug. The system also contains an interface apparatus with a plug adapter to receive the catheter plug, a voltage acquisition apparatus, and a signal generator to generate signals in response to voltages received on the electrodes. Finally, the system contains a computer capable of computing a three-dimensional volumetric electric field distribution based on signals received from the signal generator.

Abstract: Side-port sheaths for catheter placement and translation are disclosed. The sheaths include a side-port opening through which a gliding catheter may be deployed during diagnosis or treatment of tissue. The side-port sheath may include a suspension ribbon used to deploy, or that aids in the deployment of, the embedded gliding catheter. The suspension ribbon may be slideably or fixably engaged with an outer surface of the sheath of the gliding catheter.

Abstract: A lead assembly includes an outer insulative body, a conductor, and at least one electrode electrically coupled with the at least one conductor. The outer insulative body extends from a proximal end to a distal end and has an intermediate portion therebetween. A flexible portion for example having a bellows portion is disposed along the lead body.

Abstract: In a system and a method for the guidance of a catheter with an electrode in an electrophysiological procedure, sequence of images of the catheter and of a resting reference catheter is generated with an X-ray device and stored together with the associated electrographic recordings from the electrodes. A reference image may then be selected from said sequence that corresponds to a desired electrographic pattern. In a next step, the positions of the catheters are localized on the reference image. The position of the reference catheter can be identified with the position of this catheter on an actual image. Thus it is possible to determine on the actual image also a target position for the catheter that corresponds to the position of this catheter on the reference image. The target position may finally be indicated on a monitor to assist the guidance of the catheter to a desired location.

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: Disclosed herein is an implantable medical lead for implantation within a right ventricle of a heart and powered by an implantable pulse generator. The lead includes a lead body having a proximal end configured to couple to the generator, a distal end, an electrode at the distal end, and a distal portion extending proximally from the distal end. When the distal portion is in a non-deflected state, the distal portion biases to assume a configuration including first, second and third generally straight segments and first and second bends. The first segment is proximal of the distal end, the second segment is proximal of the first segment, the third segment is proximal of the second segment, the first bend is between the first and second segments, and the second bend is between the second and third segments.

Abstract: Disclosed herein is an implantable medical lead. The lead may include a longitudinally extending body having a distal end, a proximal end, a helical core assembly extending between the distal and proximal ends, and an outer jacket about the helical core assembly. The helical core assembly may have at least one helical ridge. In some instances, the at least one helical ridge may be at least two helical ridges and the helical core may further include least two helical troughs. In some such cases, the at least two helical ridges may define the at least two helical troughs.

Abstract: In a method and system for patient-specific production of a cardiac electrode lead, a 3D representation of the coronary sinus vessel tree is segmented to indicate the interior surface thereof and a representative line from an opening of the coronary sinus vessel tree to an implantation site for the electrode lead, and a computerized model of the electrode is generated that includes deformation properties of the mechanical structure of the electrode lead. A computerized virtual implantation of the electrode through the 3D representation of the coronary sinus vessel tree is implemented using the model and the internal surface and the representative line from which determination is made as to whether an electrode conforming to the model can be guided to and implanted at the implantation site in a medically acceptable manner, or whether modification of the electrode lead is necessary.

Abstract: A probe including an elongate body defining a distal region adapted to be bent into a loop and an inflatable tissue coagulation body supported on the elongate body distal region.

Abstract: An insertion device (10), by which a medical instrument or an electrode line or a guide wire or a medical therapeutic agent may be inserted into a body cavity, comprises a lumen section (11) manufactured from a flexible plastic material, having a longitudinal axis, a proximal end and a distal end, and a distal end area enclosing the distal end, at least one electrically conductive means (20) in the distal end area to sense physiological signals or stimulate the surrounding body tissue suitably, as well as at least one conductor, which extends from the proximal end to the distal end and is capable of conducting physiological signals to the proximal end and/or stimulation pulses to the distal end. The at least one electrically conductive means is produced from a flexible, not exclusively metallic, electrically conductive substrate.

Abstract: An elongate medical electrical lead conductor includes a layer of hydrolytically stable polyimide formed thereover.

Abstract: Systems and methods are provided for graphically configuring leads for a medical device. According to one aspect, the system generally comprises a medical device and a processing device, such as a programmer or computer, adapted to be in communication with the medical device. The medical device has at least one lead with at least one electrode in a configuration that can be changed using the processing device. The processing device provides a graphical display of the configuration, including a representative image of a proposed electrical signal to be applied by the medical device between the at least one electrode of the medical device and at least one other electrode before the medical device applies the electrical signal between the at least one electrode and the at least one other electrode. In one embodiment, the graphical display graphically represents the lead(s), the electrode(s), a pulse polarity, and a vector.

Abstract: A lead includes a lead body extending from a distal end to a proximal end, and at least one conductor disposed within the lead body and extending from the distal end to the proximal end of the lead body. The lead further includes an outer terminal ring, a terminal pin, and an insulative sleeve disposed between the outer terminal ring and the terminal pin, where the insulative sleeve is coupled with the outer terminal ring with a snap-fit connection. A pin latch is disposed on an outer periphery surface of the insulative sleeve, where the pin latch is rotatable about a hinge point.

Abstract: Implantable medical leads have reduced diameter while providing for optimized mechanical and electrical properties, by reducing the diameters of the conducting cables used within the leads for sensing and delivery of therapeutic electrical stimulation. In an embodiment, conducting filaments within a cable have oval cross-sectional areas. Suitably orienting the oval filaments increases the contact surface between adjacent filaments, broadly distributing the pressure between filaments and reducing fretting fatigue, while the oval cross-sectional area also increases conductivity. In an embodiment, non-conducting coatings around filaments within a cable, or around groups of filaments organized into cable-layers, reduce fretting fatigue. In an embodiment, the cross-sectional area of filaments decreases as the filaments are positioned at increasing radial distances from the center of the cable.

Abstract: A catheter assembly for treatment of cardiac arrhythmia. The catheter assembly includes a catheter body and an ablative energy source. The catheter body includes a proximal portion, an intermediate portion, and a distal portion. The intermediate portion extends from the proximal portion and defines a longitudinal axis. The distal portion extends from the intermediate portion and includes an ablation section and a tip. The ablation section forms a loop defining a diameter greater than an outer dimension of a pulmonary vein ostium. The tip extends distally from the ablation section and is configured to locate a pulmonary vein. Finally, the ablative energy source is associated with the ablation section. With this configuration, upon activation of the energy source, the ablation section ablates a desired lesion pattern. In one preferred embodiment, the ablation section forms a distally decreasing radius helix, whereas the tip includes a relatively linear leader section.

Abstract: A method of delivering a payload to a destination vessel branching from a coronary sinus of a patient's heart. The method comprises inserting a catheter assembly into a right atrium of the patient's heart. The catheter assembly comprises an outer catheter and an inner catheter movably disposed within the open lumen of the outer catheter. The inner and outer catheters are operable to be rotated and translated relative to one another such that the distal end of the outer catheter can assume a selectable plurality of shapes appropriate for accessing the coronary sinus. The method further comprises locating and cannulating the patient's coronary sinus by adjusting a relative orientation or longitudinal position of the inner catheter relative to the outer catheter, longitudinally sliding the outer catheter over the distal end of the inner catheter to deep seat the outer catheter within the patient's coronary sinus, and delivering a payload to the destination vessel through the outer catheter or the inner catheter.

Abstract: A medical electrical lead configured for use in stimulating the left side of the heart (i.e., the left ventricle). In one embodiment, the lead includes an elongate lead body including an inner surface. An inflatable member is disposed on the outer surface of the body between its proximal and distal ends, the inflatable member being adapted when inflated to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end of the lead therein. The lead further includes a conductive member extending from the proximal end toward the distal end, and an inner insulating layer positioned between the conductive member and the inner surface of the body. Separation between the inner insulating layer and the inner surface of the body defines an inflation lumen in fluid communication with the inflatable member.

Abstract: Apparatus and methods are provided for delivering a lead over a rail into a target body lumen, cavity, or other vessel, e.g., a coronary vein or a right ventricle within a patient's heart. For example, a distal end of an elongate guidewire or other rail may be introduced into the coronary venous system via the coronary sinus, advanced through the coronary venous system to a location beyond a target vessel, and secured at the location beyond the target vessel. A catheter or other elongate tubular member is advanced over the rail and manipulated to position an outlet of the tubular member adjacent to or otherwise aligned relative to the target vessel. A distal end of a lead is delivered through the tubular member and out the outlet into the target vessel. The catheter and rail are then removed, leaving the lead within the target vessel.

Abstract: An implantable lead has a lead body construction designed to accommodate loading forces exerted on the lead body during patient movement. The lead body may be sufficiently stretchable to resist forces that could otherwise cause lead failure, axial migration of the electrodes, anchor damage, or tissue damage. Increasing stretchability of a lead body can also increase the vulnerability of the lead body to flex fatigue, buckling fatigue, kinking, and crush. Therefore, the lead described herein includes conductors that comprise coiled wires positioned substantially parallel to a center axis of the lead. The conductors described herein may be coiled around fibers that limit the axial stiffness of the coiled wires to ensure full recovery from axial loading.

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.