Abstract: Aspects of the present disclosure are directed to flexible catheters for both electrophysiology mapping and ablation using a high-density array of electrodes. These catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes, and conduct monopolar and bipolar ablations of the tissue.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a shaft magnetic position sensor disposed along a distal portion of the catheter shaft. In some embodiments, the high-density electrode catheter can include a flexible tip portion located adjacent to the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible framework. In some embodiments, the high-density electrode catheter can include a plurality of electrodes disposed on the flexible framework. In some embodiments, the high-density electrode catheter can include a tip magnetic position sensor disposed on a portion of the flexible framework.

Abstract: Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a shaft magnetic position sensor disposed along a distal portion of the catheter shaft. In some embodiments, the high-density electrode catheter can include a flexible tip portion located adjacent to the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible framework. In some embodiments, the high-density electrode catheter can include a plurality of electrodes disposed on the flexible framework. In some embodiments, the high-density electrode catheter can include a tip magnetic position sensor disposed on a portion of the flexible framework.

Abstract: An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising a balloon inflatable portion with a first length configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion, a balloon proximal portion with a second length, a balloon distal portion with a third length, wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.

Abstract: An electrode assembly includes an electrode pair including a first electrode and a second electrode configured to be selectively energized for delivery of electroporation therapy. The electrode assembly also includes an expandable isolation member disposed axially between the first electrode and the second electrode. One of the first electrode and the second electrode is positioned proximally of a proximal end of the expandable isolation member and the other of the first electrode and the second electrode is positioned distal to a distal end of the expandable isolation member. The expandable isolation member is configurable between a collapsed configuration and an expanded configuration. The expandable isolation member includes a circumferential sealing surface configured for sealing engagement with tissue of a patient such that the expandable isolation member inhibits fluid and electrical communication between the first electrode and the second electrode when engaged with the tissue.

Abstract: The present invention generally relates to expandable catheters for use in electrophysiology, and more specifically to high-density balloon catheters for use in diagnosing and/or treating cardiac arrhythmias. A catheter includes an elongate catheter shaft comprising a proximal end and a distal end. The elongate catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployed configuration. The balloon member includes at least one flexible framework disposed between an outer facing layer and an inner facing layer of the top surface and/or the bottom surface of the balloon member and at least one plurality of electrodes patterned onto the flexible framework. In some embodiments, a flat balloon member includes electrodes on both sides of the planar balloon member. The balloon member may include a flexible structural element disposed within the interior cavity.

Abstract: An apparatus for detecting relative positioning of medical devices located within a human body, the apparatus comprising an inner elongate member comprising a plurality of electrodes and a first sensor member, where the first sensor member is located a known distance from each of the plurality of electrodes, and an outer elongate member comprising a first sensor, and an outer sensor member located between the first sensor and an inner wall of the outer elongate member, where the inner elongate member is configured to move within the outer elongate member and the first sensor is configured to sense a signal generated by movement of the inner elongate member relative to the outer elongate member, and a position detection module including an electronic control unit configured to detect a position of the first sensor member relative to the first sensor based on the signal.

Abstract: A medical device, system, and method having a flexible shaft and a multi-core fiber within the flexible shaft. The multi-core fiber includes a plurality of optical cores dedicated for shape sensing sensors, and a plurality of optical cores dedicated for force sensing sensors. A tip assembly can comprise a tip electrode and a coupler comprising at least one fiber support tube center. A distal portion of the coupler can be coupled to a proximal portion of the tip electrode. The tip assembly can further comprise a multi-core fiber comprising a plurality of cores and a fiber support tube. A proximal portion of the fiber support tube can be coupled to the at least one fiber support tube center.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising a balloon inflatable portion with a first length configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion, a balloon proximal portion with a second length, a balloon distal portion with a third length, wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.

Abstract: Various embodiments of the present disclosure can include a medical device for providing therapy to heart tissue. The medical device can comprise a balloon, a movable manifold, wherein the movable manifold comprises a first plurality of openings and the movable manifold is inside the balloon and the movable manifold is configured to distribute a fluid within the balloon, an elongate shaft with a proximal end portion and a distal end portion, wherein the distal end portion of the elongate shaft is coupled with the balloon, a central lumen, wherein the movable manifold is movably coupled with the central lumen, and a supply lumen comprising a supply lumen proximal end and a supply lumen distal end, wherein the supply lumen is longitudinally movable and in fluid communication with the movable manifold, wherein the movable manifold is configured to move longitudinally in response to an actuation of the supply lumen proximal end.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: A deflectable catheter is disclosed. The deflectable catheter includes a deflectable shaft including a proximal portion and a distal portion, the distal portion of the deflectable shaft including one or more electrodes. The deflectable catheter also includes a pull ring disposed in the distal portion of the deflectable shaft, a first pull wire, and a second pull wire. Both the first pull wire and the second pull wire extend through the proximal portion of the deflectable shaft and a distal end of the first pull wire and a distal end of the second pull wire are coupled to the pull ring. The deflectable catheter also includes a cylindrical braid structure at least partially disposed within the distal portion of the deflectable shaft.

Abstract: An apparatus for detecting relative positioning of medical devices located within a human body, the apparatus comprising an inner elongate member comprising a plurality of electrodes and a first sensor member, where the first sensor member is located a known distance from each of the plurality of electrodes, and an outer elongate member comprising a first sensor, and an outer sensor member located between the first sensor and an inner wall of the outer elongate member, where the inner elongate member is configured to move within the outer elongate member and the first sensor is configured to sense a signal generated by movement of the inner elongate member relative to the outer elongate member, and a position detection module including an electronic control unit configured to detect a position of the first sensor member relative to the first sensor based on the signal.

Abstract: A medical device, system, and method having a flexible shaft and a multi-core fiber within the flexible shaft. The multi-core fiber includes a plurality of optical cores dedicated for shape sensing sensors, and a plurality of optical cores dedicated for force sensing sensors. A tip assembly can comprise a tip electrode and a coupler comprising at least one fiber support tube center. A distal portion of the coupler can be coupled to a proximal portion of the tip electrode. The tip assembly can further comprise a multi-core fiber comprising a plurality of cores and a fiber support tube. A proximal portion of the fiber support tube can be coupled to the at least one fiber support tube center.

Abstract: Aspects of the present disclosure are directed to, for example, a high-thermal-sensitivity ablation catheter tip including a thermally-insulative ablation tip insert supporting at least one temperature sensor electrically coupled to a flexible electronic circuit and encapsulated, or essentially encapsulated, by a conductive shell. Also disclosed is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using various forms of energy and energy delivery.

Abstract: A medical device for the diagnosis or treatment of tissue in a body and method for fabricating the same are provided. The device includes comprises a first shaft and a second shaft. The first shaft includes a longitudinal axis, and the second shaft includes a second shaft axial end disposed within the first shaft. The second shaft is connected to the first shaft by a first nested lap joint formed between the first shaft and the second shaft.

Abstract: A medical device, system, and method having a flexible shaft and a multi-core fiber within the flexible shaft. The multi-core fiber includes a plurality of optical cores dedicated for shape sensing sensors, and a plurality of optical cores dedicated for force sensing sensors. A medical device flexing structure assembly can comprise a multi-core fiber comprising a plurality of cores, and a flexing structure comprising at least one slot. Each of the plurality of cores can comprise a fiber Bragg grating, and the flexing structure can be configured to bend in response to a force imparted on the flexing structure.

Abstract: A catheter assembly is provided. The catheter assembly includes a tip electrode array including at least one tip electrode, the tip electrode array located at a distal end of the catheter assembly, and a mini electrode array including a plurality of mini electrodes, the mini electrode array positioned proximal of the tip electrode array, wherein each of the at least one tip electrode and each of the plurality of mini electrodes are configured to be activated independent of one another for mapping applications, and wherein at least some of the at least one tip electrode and the plurality of mini electrodes are configured to be activated in unison for ablation applications.