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: 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 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: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter. Tip electrodes can be constructed from an electrically insulative substrate comprising an inner lumen, an external tip surface, and a plurality of channels extending from the inner lumen to the external tip surface, a plurality of segmented electrodes, and a plurality of spot electrodes. Each of the plurality of segmented electrodes and each of the plurality of spot electrodes can be laterally separated from each other by an electrically non-conductive substrate portion and each of the spot electrodes and each of the segmented electrodes can be electrically coupled to at least one wire or conductor trace.

Abstract: A method of manufacturing an ultrasound transducer is provided. The ultrasound transducer is activated and the activity across the transducer is measured to determine whether the activity at any area does not meet an acceptance criteria. The transducer is then modified so that the area meets the acceptance criteria. The transducer may be modified with a laser which removes material from the area which does not meet the acceptance criteria.

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: 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: A method of manufacturing an ultrasound transducer is provided. The ultrasound transducer is activated and the activity across the transducer is measured to determine whether the activity at any area does not meet an acceptance criteria. The transducer is then modified so that the area meets the acceptance criteria. The transducer may be modified with a laser which removes material from the area which does not meet the acceptance criteria.

Abstract: A tissue ablation system facilitates lesioning deep tissue while preventing damage to superficial tissue and includes a probe having a distal end portion, at least one transducer carried on the distal end portion, and at least one acoustically transparent heat removal element thermally coupled to a target tissue within the beam path of the transducer. The transducer delivers acoustic energy to the tissue through the heat removal element in order to ablate the tissue; the heat removal element removes sufficient thermal energy from the tissue volume to prevent thermal necrosis in superficial tissue. The heat removal element may be a heat sink or a convective element. An optional temperature sensor provides advisory data to a practitioner and/or is coupled to a feedback control system operable to control delivery of acoustic energy to the tissue and/or a rate of thermal energy removal therefrom.

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: An ablation system comprises a tool including an shaft having proximal and distal end portions, a handle at the proximal end portion, and a lumen extending between the proximal and distal end portions. The system further includes an ablation subsystem comprised of an ablation element at the distal end portion of the shaft, and an ablation source connected to the ablation element. The system further includes an imaging subsystem comprising an ultrasound imaging transducer disposed proximate the ablation element. The transducer is pivotally attached to the shaft or the ablation element to allow the transducer to articulate between stowed and deployed positions. The imaging subsystem further comprises a processor connected to the transducer configured to receive image data acquired by the transducer, and to generate an image corresponding thereto. The imaging subsystem still further includes a display connected to the processor configured to display the generated image.

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: 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 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: 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: An ablation catheter comprises: an elongated catheter body extending along a longitudinal axis; at least one ablation element disposed in a distal portion which is adjacent the distal end of the catheter body to ablate a targeted tissue region outside the catheter body; a single pulse-echo ultrasonic transducer disposed in the distal portion and arranged to emit and receive an acoustic beam along a centroid in a beam direction, at a transducer angle of about 30-60 degrees relative to a distal direction of the longitudinal axis at a location of intersection between the longitudinal axis and the beam direction of the centroid of the acoustic beam; and a mechanism to manipulate the distal portion in movement including rotation of at least the distal portion around the longitudinal axis. The single ultrasonic transducer emits and receives acoustic pulses to provide lesion information in the targeted tissue region being ablated.

Abstract: An ablation catheter with acoustic monitoring comprises an elongated catheter body; a distal member disposed adjacent a distal end and including an ablation element to ablate a biological member at a target region outside the catheter body; and one or more acoustic transducers each configured to direct an acoustic beam toward a respective target ablation region and receive reflection echoes therefrom. The distal member includes a transducer housing in which the acoustic transducers are disposed, the transducer housing including at least one transducer window which is the only portion in the distal member through which the acoustic beam passes, at least the at least one transducer window portion of the distal member being made of a material comprising at least 50% carbon by volume, the transducer window material having an acoustic impedance between that of the acoustic transducers and that of the biological member.

Abstract: An ablation system comprises a catheter including a pulse-echo ultrasonic transducer disposed in a distal portion and arranged to emit and receive an acoustic beam. The transducer emits and receives acoustic pulses to provide transducer detected information regarding the targeted tissue region being ablated. A rotation mechanism rotates at least the distal portion around a longitudinal axis of the catheter. A control and interface system processes the transducer detected information and provides feedback to a user via a user interface and/or the control and interface system to be used to control ablation. The transducer detected information includes a detected lesion depth along a beam emanation direction. The control and interface system includes a lesion depth correction module which converts the detected lesion depth along the beam direction to a corrected lesion depth in a normal direction which is perpendicular to the tissue surface in contact with the ablation element.

Abstract: A system for ablation with acoustic feedback comprises: a catheter which includes an elongated catheter body; at least one ablation element to ablate a targeted tissue region; and a pulse-echo ultrasonic transducer arranged to emit and receive an acoustic beam along a centroid in a beam direction, at a transducer beam angle of between about 30 degrees and about 60 degrees relative to a distal direction of the longitudinal axis at a location of intersection between the longitudinal axis and the beam direction of the centroid of the acoustic beam of the ultrasonic transducer, wherein the transducer transmits and receives acoustic pulses to provide lesion information in the targeted tissue region; an ablation power subsystem; an ultrasonic transmit and receive subsystem to operate the ultrasonic transducer; a control subsystem to control operation of the ablation power subsystem and the ultrasonic transmit and receive subsystem; and a display.

Abstract: A high intensity focused ultrasound transducer includes an ultrasonic emitter having a surface that emits ultrasonic energy along a beam path, at least one low attenuation polymeric ultrasonic lens acoustically coupled to the surface in the beam path of the ultrasonic energy, such that the lens can direct the ultrasonic energy in at least one direction, and at least one stress mitigation feature, such as a kerf, a heat sink, or an acoustic matching layer, to mitigate thermal expansion mismatch stresses within the transducer. For manufacturing simplicity, the first surface is typically either flat or monotonically curvilinear. The lens may take a variety of shapes, including Fresnel features, and may focus, collimate, or defocus the ultrasonic energy. Any orientation and positioning of the at least one ultrasonic lens relative to the first ultrasonic emitter is contemplated. Manufacture is further simplified by molding, casting, or thermoforming the lens.