Abstract: An ablation catheter comprises an elongated catheter body; at least one ablation element disposed in a distal portion which is adjacent the distal end of the catheter body; an illumination optical element disposed in the distal portion, the illumination optical element being light-transmissive to emit light from the illumination optical element to the targeted tissue region; and a collection optical element disposed in the distal portion, the collection optical element being light-transmissive to collect one or more of returned, backscattered or newly excited light from the targeted tissue region. The illumination or excitation optical element and the collection optical element are axially spaced from one another and axially optically isolated from one another within the distal portion to substantially prevent light from traveling between the illumination optical element and the collection optical element along a path within the distal portion.

Abstract: A deflectable, flexible device includes an elongate body, a convoluted tip portion at a distal end of the elongate body, and a lumen to receive one or more wires. The convoluted tip portion includes an electroformed pleated region which is formed by electrodepositing a metal on a mandrel having a pleated region. The convoluted tip portion may be hermetically sealed to permit repeated sterilization. The electroformed pleated region may include one or more fluid emission orifices. The convoluted tip portion extends or bends in response to fluid pressure manipulation, contact with tissue, manipulation with an internal spring or wire, or by a user pushing, pulling, or twisting the catheter directly or via an introducer sheath or the like. The convoluted tip portion may further include an RF ablation element or other energy-driven technique to create continuous linear lesions or a sensing element.

Abstract: An ablation catheter comprises: an elongated catheter body extending longitudinally between a proximal end and a distal end along a longitudinal axis; a distal member disposed adjacent the distal end, the distal member including an ablation element to ablate a biological member; one or more acoustic transducers disposed in the distal member and each configured to direct an acoustic signal toward a respective target ablation region and receive reflection echoes therefrom; and an acoustic redirection member disposed in the distal member to at least partially redirect the acoustic signal from at least one of the acoustic transducers toward a tissue target. The distal member includes a most-distal portion, a proximal portion, and a deflectable portion between the most-distal portion and proximal portion to permit deflection between the most-distal portion and proximal portion of the distal member. The transducers and redirection member are mounted on opposite sides of the deflectable portion.

Abstract: A catheter comprises an expandable spline structure defining a distal tip portion of the catheter. The spline structure comprises a plurality of individual splines, and each spline is configured to support a plurality of energy transfer elements and/or temperature sensors. An expandable balloon configured to be associated with the spline structure is unattached to the spline structure along its length.

Abstract: Devices and methods for creating radial-linear lesions in pulmonary vein antral tissue are disclosed. In an embodiment, a device includes an elongate shaft structure with a distal tip ablation region including a spline and an ablation element slidably coupled to the spline. The ablation element includes at least one of an ultrasound emitter, a high frequency ultrasound emitter, a laser, a radiofrequency electrode, a virtual radiofrequency electrode, or a cryogenic source. A backing balloon may be configured to push or pull the spline and the ablation element toward or against the pulmonary vein antral tissue. In an embodiment, the distal tip ablation region includes a splineless cryoballoon with at least one thermally conductive region.

Abstract: A force-sensing tip assembly for a catheter comprises a tip shell, an acoustic transducer, a first target, and a first spring. The tip shell is for joining to the catheter. The acoustic transducer is disposed within the tip shell and is capable of generating an acoustic ping. The first target is spaced from the acoustic transducer within the tip shell. The first spring is in the tip shell and configured to allow a relative position between the acoustic transducer and the first target to change over a range. The first target is shaped and positioned to reflect at least a portion of the acoustic ping back to the acoustic transducer as a first echo over at least a portion of the range.

Abstract: A tip for a medical device includes a hollow body having a window, a sensor positioned within the hollow body and oriented such that its active surface is pointed towards the window, and a membrane positioned within a beam path of the sensor. The membrane passes energy without preventing an outer surface of the hollow body of the tip from coming in contact with tissue, thus allowing the hollow body to deliver therapy to an adjacent tissue and/or diagnose adjacent tissue. The membrane can cover the window or the sensor. The membrane is desirably permeable to an irrigant, such that a suitable level of irrigant outflow from the window is maintained, and thin enough that it minimizes attenuation of energy passing to and/or from the sensor.

Abstract: Systems and methods for aligning directionally operable medical devices with and upon target tissue. Systems and methods for aligning medical devices such as directional ablation catheters to and upon target tissue by monitoring irrigant backpressure. The current disclosure provides solutions to the problem of rotationally or angularly aligning a directional medical device toward tissue.

Abstract: Methods and apparatus for the reproducible, consistent and efficacious delivery of an HBV vaccine to a subject. The disclosure comprises apparatus for the controlled administration of the HBV vaccine through an orifice to the subject, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and an electrical signal generator operatively connected to the electrodes.

Abstract: Methods and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a subject. The present disclosure comprises apparatus for the controlled administration of the therapeutic agent through an orifice to the subject, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and an electrical signal generator operatively connected to the electrodes.

Abstract: An ablation catheter comprises an elongated catheter body; at least one ablation element disposed in a distal portion which is adjacent the distal end of the catheter body; an illumination optical element disposed in the distal portion, the illumination optical element being light-transmissive to emit light from the illumination optical element to the targeted tissue region; and a collection optical element disposed in the distal portion, the collection optical element being light-transmissive to collect one or more of returned, backscattered or newly excited light from the targeted tissue region. The illumination or excitation optical element and the collection optical element are axially spaced from one another and axially optically isolated from one another within the distal portion to substantially prevent light from traveling between the illumination optical element and the collection optical element along a path within the distal portion.

Abstract: Various embodiments of the present disclosure can include an apparatus. The apparatus can include a balloon and a coil inside the balloon. The apparatus can also include an elongate shaft with a proximal end portion and a distal end portion, where the distal end portion of the shaft is coupled with the balloon. The elongate shaft can include a lumen, wherein the lumen comprises a first lumen portion inside the shaft and a second lumen portion inside the balloon. The apparatus can include a closed loop circulation path where the elongate shaft, the lumen, and the balloon are configured to circulate a fluid through the closed loop circulation path.

Abstract: An ablation catheter comprises an elongated catheter body; at least one ablation element disposed in a distal portion which is adjacent the distal end of the catheter body; an illumination optical element disposed in the distal portion, the illumination optical element being light-transmissive to emit light from the illumination optical element to the targeted tissue region; and a collection optical element disposed in the distal portion, the collection optical element being light-transmissive to collect one or more of returned, backscattered or newly excited light from the targeted tissue region. The illumination or excitation optical element and the collection optical element are axially spaced from one another and axially optically isolated from one another within the distal portion to substantially prevent light from traveling between the illumination optical element and the collection optical element along a path within the distal portion.

Abstract: A directable acoustic transducer assembly is presented for use in a medical insertion device (MID). In an embodiment, the assembly aims an acoustic signal in response to a sensed or detected force or load imposed on the MID. The directable acoustic transducer assembly includes a switch array and a plurality of directional acoustic transducer elements. The switch array responds to the force or load and activates the directional acoustic transducer elements closest to the source of the force or load. The switch array may include a plurality of switches, at least one of which responses to a force or load and may activate directional acoustic transducer elements having a target tissue in the field of view. The assembly includes embodiments that are responsive to various loads. A directable acoustic transducer assembly may be part of a diagnostic and/or therapeutic system, such as an RF ablation system.

Abstract: The present disclosure relates generally to systems and methods for aligning directionally operable medical devices with and upon target tissue. In particular, the instant disclosure relates to systems and methods for aligning medical devices such as directional ablation catheters to and upon target tissue by monitoring irrigant backpressure.

Abstract: Aspects of the present disclosure relate to electrophysiology catheters for cardiac medical procedures. More specifically, the instant disclosure relates to an ablation catheter for treating cardiac arrhythmias by ablating tissue, and having one or more subelectrodes internally fixed within the ablation catheter tip to capture electrophysiology characteristics of myocardial tissue in proximity to the one or more subelectrodes.

Abstract: A directable acoustic transducer assembly is presented for use in a medical insertion device (MID). In an embodiment, the assembly aims an acoustic signal in response to a sensed or detected force or load imposed on the MID. The directable acoustic transducer assembly includes a switch array and a plurality of directional acoustic transducer elements. The switch array responds to the force or load and activates the directional acoustic transducer elements closest to the source of the force or load. The switch array may include a plurality of switches, at least one of which responses to a force or load and may activate directional acoustic transducer elements having a target tissue in the field of view. The assembly includes embodiments that are responsive to various loads. A directable acoustic transducer assembly may be part of a diagnostic and/or therapeutic system, such as an RF ablation system.

Abstract: The present disclosure provides catheter systems, electrode assemblies, and methods for electrically stimulating one or more points about the circumference of the renal artery to provide real time intraprocedural operational feedback to the operator of a renal denervation procedure to allow for more precise and thorough ablation of the renal artery and better patient outcomes. In many embodiments, an electrode assembly is provided that includes multiple splines that extend from an insulated proximal hub to an insulated distal hub and are interconnected to an electrical wire to allow the splines to independently function as electrical stimulation electrodes. The electrically active splines can then be energized at one or more desired points during a renal denervation procedure to provide operational feedback.

Abstract: Systems and methods for aligning directionally operable medical devices with and upon target tissue. Systems and methods for aligning medical devices such as directional ablation catheters to and upon target tissue by monitoring irrigant backpressure. The current disclosure provides solutions to the problem of rotationally or angularly aligning a directional medical device toward tissue.

Abstract: An apparatus for imaging tissue in three dimensions (e.g. ICE catheter) includes a shaft, a static imaging element (20) disposed within the shaft, an oscillating energy deflector (24) positioned within the beam path of the imaging element, and a drive assembly operable to oscillate the energy deflector. The imaging element can be acoustic or electromagnetic, and the energy deflector can be a prism, a lens or an acoustic mirror. By oscillating the energy deflector and/or by providing an asymmetric energy deflector, a plurality of two-dimensional image slices can be obtained. These image slices can then be assembled into a three-dimensional volumetric image.