Devices and systems for the selective positioning of an intravascular neuromodulation device are disclosed herein. Such systems can include, for example, an elongated shaft and a therapeutic assembly carried by a distal portion of the elongated shaft. The therapeutic assembly is configured for delivery within a blood vessel. The therapeutic assembly can include a pre-formed shape and can be transformable between a substantially straight delivery configuration; and a treatment configuration having the pre-formed helical shape to position the therapeutic assembly in stable contact with a wall of the body vessel. The therapeutic assembly can also include a mechanical decoupler operably connected to the therapeutic assembly that is configured to absorb at least a portion of a force exerted on the therapeutic assembly by the shaft so that the therapeutic assembly maintains a generally stationary position relative to the target site.

The present invention provides a double-layer cryogenic inflatable balloon including an inflatable balloon assembly and a cryogenic balloon assembly. The inflatable balloon assembly includes an inflatable balloon, an outer catheter and a liquid-filling cavity provided with a liquid-filling chamber, the inflatable balloon, the outer catheter and the liquid-filling cavity being communicated with each other. The cryogenic balloon assembly includes a cryogenic balloon, an inner catheter and a fluid-diverting cavity provided with a gas return chamber as well as a gas inlet pipe and an inflation assembly, the cryogenic balloon, the inner catheter and the fluid-diverting cavity being communicated with each other, wherein the cryogenic balloon is located in the inflatable balloon, and the inner catheter is located in the outer catheter. The fluid-diverting cavity is further provided with a gas return channel, a liquid-filling channel, and a cork chamber, wherein the gas return channel has one end communicated with the gas return chamber and the other end communicated with the cork chamber. The liquid-filling channel has one end communicated with the cork chamber and the other end communicated with the liquid-filling chamber. The cork chamber is communicated with a gas return joint, and is internally provided with an adjustment structure. The fluid-diverting cavity is provided with a gas inlet chamber, and the gas inlet pipe penetrates through the cryogenic balloon, the inner catheter and the fluid-diverting cavity, the gas inlet pipe having one end located in the cryogenic balloon and the other end communicated with the gas inlet chamber. The gas inlet chamber is communicated with the inflation assembly, and the inflation assembly is used to input a refrigerant gas into the cryogenic balloon through a pipe.

According to various embodiments, systems, devices and methods for modulating targeted nerve fibers (e.g., hepatic neuromodulation) or other tissue are provided. Systems, devices and methods for cooling energy delivery members are also provided. The systems may be configured to access tortuous anatomy of or adjacent hepatic vasculature. The systems may be configured to target nerves surrounding (e.g., within adventitia of or within perivascular space of) an artery or other blood vessel, such as the common hepatic artery.

A catheter system (100) used for treating a treatment site (106) within or adjacent to the heart valve (108) includes an energy source (124), an energy guide (122A), and a balloon assembly (104). The energy source (124) generates energy. The energy guide (122A) is configured to receive energy from the energy source (124). The balloon assembly (104) is positionable substantially adjacent to the treatment site (106). The balloon assembly (104) includes an outer balloon (104B) and an inner balloon (104A) that is positioned substantially within the outer balloon (104B). Each of the balloons (104A, 104B) has a balloon wall (130) that defines a balloon interior (146). Each of the balloons (104A, 104B) is configured to retain a balloon fluid (132) within the balloon interior (146). The balloon wall (130) of the inner balloon (104A) is positioned spaced apart from the balloon wall (130) of the outer balloon (104B) to define an interstitial space (146A) therebetween. A portion of the energy guide (122A) that receives the energy from the energy source (124) is positioned within the interstitial space (146A) between the balloons (104A, 104B) so that a plasma-induced bubble (134) is formed in the balloon fluid (132) within the interstitial space (146A).

Diagnostic and therapeutic medical devices and methods that include an elongate shaft, a balloon, a plurality of electrodes carried by the balloon, and electronics to electrically connect the electrodes to a proximal end of the shaft. The devices can include a visualization system within the balloon.

A catheter-based medical device including controlled refrigerant dispersion is disclosed. The device includes a fluid injection tube that carries refrigerant from a coolant supply to the distal portion of the device. A fluid dispersion unit is disposed on the distal end of the fluid tube to control the angle of distribution for refrigerant that is expelled from the fluid injection tube. Controlling the angle of distribution for the refrigerant facilitates dispersion of the fluid in a predetermined spray pattern. The disclosure further relates to cryoablation treatment systems incorporating such a catheter, and to cryoablation treatment methods for tissue treatment to address various conditions suitably treatable with cryoablation.

Systems, devices and methods for performing medical procedures in the intestine of a patient are provided. A medical device for performing a treatment and/or a diagnostic procedure can include an elongate shaft assembly comprising at least a shaft assembly first section comprising a distal section of the shaft assembly, and a shaft assembly second section proximal to the first section, and a functional assembly positioned on the shaft assembly first section. Additional sections of the shaft assembly can be included, and each section can comprise a different construction, such as to achieve a different stiffness as described herein. Variable stiffness along the length of the shaft assembly can be provided to aid in translation of the device through the patient's GI tract (e.g. through the stomach and into the small intestine), as described herein.

A method of predicting an adverse event during an ablation procedure includes providing a medical device having an expandable element and positioning the medical device proximate to an area of target tissue. The medical device includes a fluid exhaust lumen and a fluid supply lumen each being in fluid communication with the expandable element. The method further includes delivering fluid to expandable element and exhausting fluid from the expandable element; measuring a pressure within a vacuum return path; and measuring a period of time it takes for the pressure within the vacuum return path to reach a target pressure.

An irrigation balloon catheter includes one or more inner balloons inside of an irrigation balloon. The inner balloon(s) can be compliant with a volume that is dynamically adjustable for rapid inflation, rapid deflation, complete deflation, and/or irrigation flow adjustment. An inflator tool can be configured to inflate or deflate the inner balloon to adjust flow from the outer, irrigation balloon to affect temperature at electrodes of the irrigation balloon.

An intravascular catheter is provided, including a flexible elongate body; an expandable element positioned on the elongate body; a substantially linear thermal segment located proximally of the expandable element, the thermal segment defining a first flexibility, where the thermal segment is positioned between two portions of the catheter body each including a flexibility less than that of the thermal segment; a first fluid flow path in fluid communication with the expandable element; and a second fluid flow path in fluid communication with the thermal segment.