Abstract: Medical devices and methods for making and using medical devices are disclosed. A method of mapping electrical activity of a heart may comprise sensing a plurality of signals with a plurality of electrodes positioned within the heart. The method may further comprise separating the plurality of signals into a first group of signals and a second group of signals, and generating a data set that includes at least one known data point and one or more unknown data points. In some examples, the at least one known data point is generated based on the first group of signals.

Abstract: A medical device lead includes a tubular conductive element disposed over a lead body. The tubular conductive element includes at least one segment having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect at least one electrical property, e.g., electrical impedance, of the segment. The segment may form a shocking conductor of the medical device lead. The tubular conductive element may alternatively include proximal, intermediate and distal segments each having one or more kerfs formed radially therethrough, where the one or more kerfs in each of the proximal and intermediate segments are configured so that these segments each have a higher electrical impedance than the distal segment. A layer of insulative material is disposed over the proximal and intermediate segments, so that the proximal and intermediate segments of the tubular conductive element are operable to filter electromagnetic energy from an external source.

Abstract: Systems, methods, and devices allow intravascular or percutaneous mapping, orientation or ablation, or combinations thereof in bodily cavities or lumens. A device includes a plurality of elongate members which are moveable between an unexpanded configuration, a bent or coiled stack configuration and an expanded or fanned configuration. The elongate members form a stack arrangement in the unexpanded configuration to fit through a catheter sheath. The elongate members follow respective arcuate or curvilinear paths as advanced from the sheath into the bent or coiled stack configuration, adopting volute, scroll or rho shapes, and may be nested. The elongated members are fanned or radially spaced circumferentially with respect to one another into the expanded or fanned configuration. Transducers carried by elongate members may sense various physiological characteristics of or proximate tissue, for instance temperature, and/or may apply energy to or proximate tissue, for example to perform ablation.

Abstract: An accessory and system to provide a medical device with mapping and ablation functionality. The system may include an ablation device with a handle, a treatment element, and an elongate body. The ablation element may be located on the elongate body distal portion, and a mapping sleeve may be disposable about at least part of the distal portion of the ablation device and may include mapping electrodes disposed on the outer surface. The mapping sleeve proximal region may include a retraction element defining a proximal end and a distal end, the distal end being coupled to the proximal region of the mapping sleeve, such that retracting the retraction element toward the elongate body proximal portion pulls the mapping sleeve away from the treatment element of the ablation device.

Abstract: The invention relates to a sensing apparatus for sensing an object. The sensing apparatus comprises an ultrasound unit (11) for ultrasonically sensing the object (4), an electrical energy application unit (9) for applying electrical energy to the object (4), and an ultrasound unit shielding element (16) for electrically shielding the ultrasound unit (11), wherein the ultrasound unit shielding element (16) is electrically connected to the electrical energy application unit (9). Since the ultrasound unit shielding element electrically shields the ultrasound unit, the ultrasound sensing of the object is less influenced by a capacitive coupling of the application of electrical energy, in particular, of an RF signal which may be used for applying the electrical energy, into the ultrasound sensing. A further reduction of this influence is achieved by electrically connecting the ultrasound unit shielding element to the electrical energy application unit.

Abstract: Various embodiments are described herein for a system and a method for identifying the arrhythmogenic circuit of a patient or subject. In one embodiment, the method comprises obtaining data for electrograms recorded at various locations of the heart while programmed ventricular pacing with extra stimuli was performed, obtaining decrement values for at least two different locations of the heart using the recorded electrograms, generating at least a portion of a decrement map using the decrement values, and identifying the arrhythmogenic circuit based on electrograms having significant decremental properties.

Abstract: An area of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of an area or volume can be determined based upon the sensing of the plurality of points without the use of an imaging device. An implantable medical device can then be navigated relative to the mapping data.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Stylets and catheters including various multiple bipolar and monopolar electrode configurations are also disclosed.

Abstract: A method and an electronic device are provided herein. The electronic device includes a processor. The processor may execute the method, including detecting, by a sensor, heart rate information while providing a content of the electronic device, determining, by a processor, an emotional quotient based on the detected heart rate information, and mapping the determined emotional quotient to the provided content.

Abstract: An apparatus and method are provided for spatially-selective administration of actions by at least one device in the body using a transducer that is sensitive to a spatially-variant energy field imposed on the at least one device by a source external to a subject's body; and at least one component in the at least one device, wherein interaction of the transducer with the imposed spatially-variant energy field causes or enables at least one component in the at least one device to affect nearby tissues in the body.

Abstract: Systems and methods can be used to determine activation information for points along a surface or selected region of interest. In one example, a computer-readable medium having computer-executable instructions for performing a method that includes computing a local activation vector based on relative timing among electrical signals corresponding to neighboring points of a plurality of points on a surface envelope. An activation time can be computed for each of the plurality of points as a function of corresponding local activation vectors.

Abstract: The invention discloses a method, a system, a computer program and a device for determining the surface charge and/or dipole densities on heart walls. Using the foregoing, a table of dipole densities ?(P?, t) and/or a table of surface charge densities ?(P?, t) of a given heart chamber can be generated.

Abstract: A device positionable in a cavity of a bodily organ (e.g., a heart) may discriminate between fluid (e.g., blood) and non-fluid tissue (e.g., wall of heart) to provide information or a mapping indicative of a position and/or orientation of the device in the cavity. Discrimination may be based on flow, or some other characteristic, for example electrical permittivity or force. The device may selectively ablate portions of the non-fluid tissue based on the information or mapping. The device may detect characteristics (e.g., electrical potentials) indicative of whether ablation was successful. The device may include a plurality of transducers, intravascularly guided in an unexpended configuration and positioned proximate the non-fluid tissue in an expanded configuration. Expansion mechanism may include helical member(s) or inflatable member(s).

Abstract: A catheter including expandable electrode assembly having a distal cap that mechanically engages a locking feature provided on the distal ends of each of two or more flexible splines forming a portion of the expandable electrode assembly is described. The distal cap defines an atraumatic distal tip of the catheter. The catheter may be used in a cardiac mapping and/or ablation procedure.

Abstract: Catheters including elements configured to deliver energy to nerves at or near a treatment location within a body lumen. A treatment assembly is transformable between a low-profile delivery configuration wherein a pair of electrodes are in a staggered arrangement relative to each other along the longitudinal axis, and an expanded deployed configuration wherein the pair of electrodes is aligned along an electrode axis that is orthogonal relative to the longitudinal axis.

Abstract: A system and method for treating an arrhythmia in a heart are provided. The system includes an electronic control unit configured to monitor movement of one or more position sensor over a period of time. The position sensors may, for example, comprise electrodes or coils configured to generate induced voltages and currents in the presence of electromagnetic fields. The positions sensors are in contact with portions of heart tissue and changes in position are representative of motion of that tissue. The electronic control unit is further configured to generate an indicator, responsive to the movements of the sensors over the period of time, of a characteristic of the heart affected by delivery of ablation energy to heart tissue. In this manner, the effectiveness and safety of cardiac tissue ablation for treatment of the arrhythmia can be assessed and a post-ablation therapy regimen determined.

Abstract: Systems and methods for applying stimulating current to a patient for treating insufficient uterine contractions are provided. The system includes stimulation electrodes of a balloon electrode array device, a ring electrode array device, an electrode probe device, or a mesh electrode array device. Some aspects of the invention also provide a connector and cable device for coupling the stimulation electrodes to electronics for generating and providing the stimulating current to the stimulation electrodes.

Abstract: An EP catheter includes a tubular body having a proximal region, a neck region, and a distal portion predisposed into an in-plane dual loop (at least, approximately, more or less) configuration and including a plurality of diagnostic electrodes. In deflectable catheter forms, at least one activation wire extends through at least a portion of the proximal region of the catheter body and is adapted to deflect the distal portion up to approximately 180 degrees relative to the proximal region. The catheter can be operated manually by a clinician or via a clinician-surrogate such as a computer processor-controlled surgical system. In addition, a variety of localization, visualization, and/or orientation-specific elements can be incorporated into the devices described, depicted, and claimed herein (e.g., metallic coil members, active impedance emitting or receiving electrodes, fluoroscopically opaque materials, and the like).

Abstract: Medical devices and methods for making and using the same are disclosed. An example medical device may include a catheter shaft. An expandable member may be coupled to the catheter shaft. A plurality of flexible electrode assemblies may be coupled to the expandable member. A control unit may be coupled to the electrode assemblies. The control unit may be configured to energize the electrode assemblies for approximately 10 seconds to less than approximately 1 minute.

Abstract: A method for sensing multiple local electric voltages from endocardial surface of a heart, includes: providing a system for sensing multiple local electric voltages from endocardial surface of a heart, including: a first elongate tubular member having a lumen, a proximal end and a distal end; a basket assembly including: a plurality of flexible splines for guiding a plurality of exposed electrodes, the splines having proximal portions, distal portions and medial portions therein between, wherein the electrodes are substantially flat electrodes and are substantially unidirectionally oriented towards a direction outside of the basket.

Abstract: A cochlear implant includes a processor, an array of electrodes disposed along a flexible body and a lead body connecting the processor to the array of electrodes. The lead body includes a first tube having a first outside diameter, a second tube having a second outside diameter smaller than the first diameter, a portion of the second tube being disposed within the first tube, and wires passing through the first tube and the second tube, the wires comprising a helically coiled portion. A method for forming a lead body is also provided.

Abstract: Disclosed are an electrode for high-frequency surgery, a high-frequency surgery device, and a method for controlling same, wherein the electrode for high-frequency surgery can be easily inserted and moved inside the lumens inside the body, and can expand a conduction area of a high-frequency current after reaching an area to be treated. The electrode for the high-frequency surgery, according to the present invention, comprises: a balloon; and a conductive structure, which is arranged on the outside of the balloon and the exterior shape of which varies according to the volume of the balloon.

Abstract: An irrigated catheter with uniform cooling and/or uniform fluid distribution in longitudinally spaced apart elution holes by varying the diameter of a fluid delivery lumen. A number of elution holes are provided in a tip region of a catheter body, and these elution holes are in fluid communication with the lumen through ducts. The fluid delivery lumen may be provided with a flow constrictor to restrict flow of fluid towards the distal region.

Abstract: An apparatus includes an intra-body probe and a processor. The intra-body probe includes an electrode, which is configured to contact tissue in a heart. The processor is configured to receive an electrical signal from the electrode, to distinguish a local component, due to the tissue with which the electrode is in contact, in the electrical signal from a remote-field contribution to the signal, and to control a therapeutic procedure applied to the tissue responsively to the distinguished local component.

Abstract: A medical device may include a handle housing having a side wall defining an interior space and proximal and distal apertures extending through the side wall, an elongated outer sheath, an elongated inner member, a proximal flush port disposed within the interior space and in fluid communication with the elongated inner member, and a distal flush port disposed within the interior space and in fluid communication with the elongated outer sheath. A control knob may be rotated to move the distal flush port within the interior space.

Abstract: Leads having directional electrodes thereon. Also provided are leads having directional electrodes as well as anchoring prongs to secure the electrodes to the leads. Also provided are leads with directional electrodes where all the electrodes have the same surface area. Methods of treating conditions and selectively stimulating regions of the brain such as the thalamus and cerebellum are also provided.

Abstract: A catheter includes a handle, a catheter sheath having at least one conductor within a lumen of the catheter sheath, and a stylet received within the catheter sheath. The catheter sheath is fabricated by providing a tubular member, forming an aperture in a wall of the tubular member at a distal part of the tubular member and inserting a conductor into the lumen of the tubular member. An exposed distal end of the conductor is attached to an electrode, which is then mounted onto an external surface of the tubular member to cover the aperture. The tubular member is then treated by heat to seal the electrode.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter shaft with a plurality of electrodes coupled thereto and a processor coupled to the catheter shaft. The processor may be capable of collecting a set of signals from the plurality of electrodes and generating a data set from at least one of the set of signals. The data set may include at least one known data point and one or more unknown data points. The processor may also be capable of interpolating at least one of the unknown data points by conditioning the data set, assigning an interpolated value to at least one of the unknown data points, and assigning a confidence level to the interpolated value.

Abstract: Systems, methods, and devices allow intravascular or percutaneous mapping, orientation or ablation, or combinations thereof in bodily cavities or lumens. A device includes a plurality of elongate members which are moveable between an unexpanded configuration, a bent or coiled stack configuration and an expanded or fanned configuration. The elongate members form a stack arrangement in the unexpanded configuration to fit through a catheter sheath, The elongate members follow respective arcuate or curvilinear paths as advanced from the sheath into the bent or coiled stack configuration, adopting volute, scroll or rho shapes, and may be nested. The elongated members are fanned or radially spaced circumferentially with respect to one another into the expanded or fanned configuration. Transducers carried by elongate members may sense various physiological characteristics of or proximate tissue, for instance temperature, and/or may apply energy to or proximate tissue, for example to perform ablation.

Abstract: A fixation member of an electrode assembly for an implantable medical device includes a tissue engaging portion extending along a circular path, between a piercing distal tip thereof and a fixed end of the member. The circular path extends around a longitudinal axis of the assembly. A helical structure of the assembly, which includes an electrode surface formed thereon and a piercing distal tip, also extends around the longitudinal axis and is located within a perimeter of the circular path. The tissue engaging portion of the fixation member extends from the distal tip thereof in a direction along the circular path that is the same as that in which the helical structure extends from the distal tip thereof. The electrode assembly may include a pair of the fixation members, wherein each tissue engaging portion may extend approximately one half turn along the circular path.

Abstract: A catheter and catheter system for eccentric remodeling and/or removal of atherosclerotic material of a blood vessel of a patient include an elongate flexible catheter body with a radially expandable structure. A plurality of electrodes or other electrosurgical energy delivery surfaces can radially engage atherosclerotic material when the structure expands. An atherosclerotic material detector near the distal end of the catheter body may measure circumferential atherosclerotic material distribution, and a power source selectively energizes the electrodes to eccentrically remodel the measured atherosclerotic material.

Abstract: A system for sensing monophasic action potentials from endocardial tissue of a heart, includes: a plurality of flexible splines; an anchor for securably affixing the proximal portions of the splines; a tip for securably affixing the distal portions of the splines; and a polymeric member including opposed a first open end and a second open end defining an open lumen therein between, where at least one of the plurality of flexible splines is at least partially disposed within the lumen of the polymeric member; a flexible electrode assembly strip with two or more exposed electrodes oppositely disposed on at least a portion of the outer surface of the polymeric member.

Abstract: A medical device for monitoring physical, chemical, or biological characteristics of an organ, such as the urinary bladder. The medical device may include an elongate member having a proximal end and a distal end. The device may further include an end-effector assembly extending distally from the distal end of the elongate member. The end-effector assembly may also include a plurality of sensing elements for detecting abnormal organ function. Each of the plurality of sensing elements may include one or more of mechanical, visual, chemical, and biological sensors.

Abstract: Devices, systems, and methods for performing ablation therapy on body tissue are disclosed. An example ablation device for treating body tissue includes an ionically conductive balloon and a radio-frequency electrode that delivers RF energy into a distal section of the balloon. The balloon can have a composite structure with a non-conductive section and a conductive section. The ablation device can have a steering mechanism configured to deflect the balloon.

Abstract: An electrophysiology catheter is provided. In one embodiment, the catheter includes an elongate, deformable shaft having a proximal end and a distal end and a basket electrode assembly coupled to the distal end of the shaft. The basket electrode assembly has a proximal end and a distal end and is configured to assume a compressed state and an expanded state. The electrode assembly further includes one or more tubular splines having a plurality of electrodes disposed thereon and a plurality of conductors. Each of the plurality of conductors extends through the tubular spline from a corresponding one of the plurality of electrodes to the proximal end of the basket electrode assembly. The tubular splines are configured to assume a non-planar (e.g., a twisted or helical) shape in the expanded state.

Abstract: A medical electrical lead and methods of implanting medical electrical leads in lumens. Leads in accordance with the invention employ preformed biases to stabilize the lead within a lumen and to orient electrodes in a preferred orientation.

Abstract: Compact, single-handedly manipulable, cardiography devices, structured for personal use in two, selectively different, functional-cardiography styles, enabling, respectively, one or both of (a) non-acoustic, and (b) acoustic, cardiography, such use involving, as appropriate to the particular functional-cardiography style to be implemented, the collecting and recording of personal cardiography-relevant data—ECG only in a non-acoustic case, and both ECG and heart-sound together in an acoustic case—suitable for subsequent data-analysis processing, and associated cardiovascular diagnosis. Two, representative device overall configurations are illustrated, including (1) a stylus pen-like shape, and (2) a finger-mountable ring-like shape.

Abstract: A device for creating an arteriovenous (AV) fistula includes a proximal base having a distal tapered end surface and a distal tip connected to the proximal base and movable relative to the proximal base. The distal tip has a proximal tapered end surface. A first heating assembly, including an energized heating element, is disposed on at least one of the distal tapered end surface and the proximal tapered end surface. A second heating assembly, comprising a passive non-energized heat spreader, is disposed on the other one of the distal tapered end surface and the proximal tapered end surface. The distal tapered end surface and the proximal tapered end surface are adapted to contact opposing sides of a tissue portion to create the fistula. The taper of the proximal tapered end surface matches the taper of the distal tapered end surface, so that the two surfaces match one another.

Abstract: An implantable biomedical conductor assembly is configured for at least partial insertion in a living body. The implantable conductor assembly includes an inner tubular structure and an outer tubular structure generally surrounding the inner tubular structures such that a gap of less than about 0.030 inches exists there between. A dynamic coil is located in the gap. The dynamic coil includes a plurality of insulated conductors that are coiled generally at or below a yield point. The insulated conductors are permitted to expand within the gap to engage an inner surface of the outer tubular structure in an expanded coiled configuration. At least one mechanical restraint at each of a distal end and a proximal end retains the dynamic coil in the tubular structures. Free ends of the insulated conductors extend beyond the proximal and distal ends to facilitate attachment to electrodes and connectors.

Abstract: A catheter system includes a mapping catheter including a plurality of mapping electrodes, each mapping electrode configured to sense signals associated with an anatomical structure. The catheter system further includes a processor operatively coupled to the plurality of mapping electrodes and configured to receive the signals sensed by the plurality of mapping electrodes, characterize the signals sensed by the plurality of mapping electrodes based on amplitudes of the sensed signals, and generate an output of a quality of contact of the plurality of mapping electrodes with the anatomical structure based on the signal characterization.

Abstract: Methods, systems, and devices for providing treatment to a target site are described. The system may include a guide assembly, an expandable support device coupled with the distal end of the guide assembly, and an operative member disposed on the expandable support device. The expandable support device may be configured to transition between a collapsed and expanded configuration. The expandable support device may be supported by one or more flexible supports aligned in parallel with an axis about which the expandable support device collapses and/or multiple splines arranged in a pattern configured to promote transitioning of the expandable support device between an expanded and collapsed configuration. The guide assembly may be configured to provide torque to the expandable support device. The operative member can include multiple electrodes arranged in parallel to the axis about which the expandable support device collapses.

Abstract: A method, including positioning body-electrodes in galvanic contact with a body of a patient and locating a probe in the body of the patient. The method further includes tracking positions of the probe during respiration of the patient and determining indications related to impedances between the body-electrodes during the respiration. The method also includes calculating a function relating the positions of the probe to the indications, and applying the function to identify end-expirium points of the respiration based on subsequent indications related to the impedances.

Abstract: An inner member of an improved assembly for a delivery system includes a first segment formed by a multi-lumen tubing surrounded by a braided tubing, and a second segment formed by a single-lumen tubing that extends within a distal portion of the braided tubing. The single-lumen tubing accommodates an antenna of a medical device, is in fluid communication with three lumens of the multi-lumen tubing, and opens into a flared distal end of the inner member. A distal-most portion of an outer tube of the system contains the flared distal end and an enclosure of the medical device abutting the distal end. A pull wire of the assembly extends within another lumen of the multi-lumen tubing and between the single-lumen tubing and the distal extent of the braided tubing, and is coupled to a pull band mounted in a cone member that forms the flared distal end.

Abstract: A catheter includes a flexible shaft having a distal end dimensioned for deployment within a patient's renal artery. A number of elongated resilient members are mounted along a longitudinal length of the distal end of the shaft, and are extensible radially from the shaft at regions defined between longitudinally spaced-apart engagement locations. One or more electrodes are mounted on each of the resilient members at the radially extensible regions. A number of conductors are electrically coupled to the electrodes and extend along the shaft of the catheter. The elongated resilient members are collapsible when encompassed within a lumen of an outer sheath and extensible radially outward from the shaft at the regions defined between the longitudinally spaced-apart engagement locations when the catheter and the resilient members are axially extended beyond the distal tip of the sheath. RF energy is delivered to the electrodes for ablating perivascular renal nerves.

Abstract: In various embodiments, a catheter comprising an expandable electrode assembly or basket is provided. In specific embodiments, the basket is particularly useful for mapping electrical activity at one or more locations within the heart. The basket can comprise a plurality of bendable or deflectable arms. At least one of the arms may have varied flexibility over its length in the form of one or more discontinuities of stiffness or flexibility at an elbow region or other variances in flexibility over the arm's length. Such variance in flexibility may allow the arm to assume a different bent configuration or respond to external factors more positively than possible with an arm having a static or near static flexibility or stiffness over its length.

Abstract: A lead stimulation/recording system is provided, which is a combination of a permanent DBS stimulating lead and a recording microelectrode. The DBS lead has a lumen extending from the proximal to the distal end of the lead, the lumen having an opening on each end of the lead. The microelectrode is configured and dimensioned to be insertable into the DBS lead from either the distal or proximal opening of the DBS lead, thereby permitting the microelectrode to be placed before, concurrently with, or after placement of the DBS lead. In addition, the system may be used with known microelectrode recording systems and methods of inserting the electrodes, such as the five-at-a-time method, the dual-microdrive method, or the single microdrive method.

Abstract: The present invention relates to a method, device, and system for improved mapping and/or ablation of a tissue. The device may generally include an elongate body and a distal assembly affixed to the elongate body that includes a treatment electrode having a conductive mapping region and a selectively conductive ablation region that is conductive of high-frequency current and substantially non-conductive of low-frequency current. Alternatively, the device may generally include a treatment electrode having a conductive mapping or ablation region and a region that is coated with an electrically insulated but thermally conductive layer.

Abstract: A catheter has an inflatable assembly at its distal portion, including a containment chamber, an axial core and a plurality of longitudinally oriented partitions extending from the axial core to the wall of the chamber to divide the containment chamber into at least four inflatable sectors. Hydraulic valves are connected to respective sectors to enable selective inflation of the sectors by a fluid when the valves are connected to a source of the fluid, and at least one surface electrode is mounted on each of the sectors. When introduced into a heart chamber and diametrically opposed sectors are inflated the assembly is stably fixed against the walls of the heart chamber and readings can be obtained from the surface electrodes of the inflated sectors.

Abstract: A sphincter treatment apparatus includes an energy delivery device introduction member including a proximal end with a first radius of curvature and a distal end with a second radius of curvature. The introduction member is configured to be introduced into the sphincter in a non-deployed state and to be expanded to a deployed state to at least partially expand the sphincter or an adjoining structure. An energy delivery device is coupled to the introduction member. A retainer member is coupled to the energy delivery device introduction member and configured to controllably position the introduction member in an orifice of the sphincter.

Abstract: An electrophysiology catheter, e.g., a coronary sinus catheter, for insertion into a cardiac vessel, such as the coronary sinus, includes a handle and a catheter shaft coupled at one end to the handle. The catheter shaft has a distal end and an anchor is associated with the catheter shaft and is movable between a deployed position and a collapsed position. In the deployed position, the anchor extends radially outward from an outer surface of the catheter shaft for contacting a wall and temporarily anchoring the catheter shaft within the coronary sinus. The catheter also includes an actuator for causing deployment and collapsing of the anchor upon manipulation of the actuator.