Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: 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.

Abstract: Novel tools and techniques are provided for implementing intelligent assistance (“IA”) ecosystem, and, in some cases, for implementing extended reality (“XR”) for cardiac arrhythmia procedures. In various embodiments, a computing system might receive device data associated with a device(s) configured to perform a cardiac arrhythmia procedure to provide effective heart rhythm, might receive imaging data associated with an imaging device(s) configured to generate images of a portion(s) of a patient. The computing system might analyze the received device data and imaging data (collectively “received data”), might map the received data to a 3D or 4D representation of the portion(s) of the patient based on the analysis, and might generate and present (using a user experience (“UX”) device) one or more XR images or experiences based on the mapping.

Abstract: The present invention provides a medical system, including a catheter defining an injection lumen, a chamber in fluid communication with the injection lumen, and an exhaust lumen in fluid communication with the chamber; a first temperature sensor positioned in the exhaust lumen proximal to the chamber; a second temperature sensor positioned in the chamber; and a console in electrical communication with the first and second temperature sensors, the controller modifying coolant flow through the medical device based at least in part upon a signal received from the first and second temperature sensor. The system may further include a thermally-conductive element circumscribing a substantial portion of the exhaust lumen proximal to the chamber, where the first temperature sensor is mounted to the thermally-conductive element, and the thermally-conductive element may include at least one of a braid, coil, and band.

Abstract: A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.

Abstract: Devices, systems, and methods for maintaining cryoballoon size, cryoballoon pressure, and/or coolant flow rate based on physical characteristics of the tissue to be ablated. In one embodiment, a cryoablation system comprises: a cryoablation device, the cryoablation device including: an expandable treatment element defining an interior chamber; and a pressure sensing system at least partially within the interior chamber; a fluid flow path including at least one valve that is in communication with at least one PID device; and a control unit including processing circuitry in communication with the pressure sensing system and the at least one PID device, the processing circuitry being configured to: determine a target pressure of the expandable treatment element based on a target size of the expandable treatment element; and determine a target flow rate of coolant through the fluid flow path based on the target pressure of the expandable treatment element.

Abstract: A medical device including an outer tube, an expandable chamber coupled to the outer tube, and an injection tubular member in fluid communication with an interior of the expandable chamber. The injection tubular member is coupled to a source of fluid and a distal end within the expandable chamber and a fluid nozzle is located in a distalmost end face of the distal end of the injection tubular member. A fluid dispersion unit is coupled to the injection tubular member with a longitudinal axis, the fluid nozzle being within the fluid dispersion unit and configured to direct a flow of fluid into the fluid dispersion unit. The fluid dispersion unit has an opening to direct a flow path of the flow of fluid expelled by the fluid nozzle within the fluid dispersion unit and into an interior surface of the expandable chamber from the opening at the distalmost end face.

Abstract: A device and system for thermally affecting tissue that includes a balloon catheter with a reduced distal length for ease of navigation and that also includes a balloon that is more resistant to bursting and delamination. The balloon may include a proximal neck generally attached to an elongate body and a distal neck generally attached to a shaft disposed within the elongate body. The distal neck is turned inward to extend within the balloon chamber and the proximal neck may either extend within the chamber or extend proximally away from the balloon chamber. Alternatively, the device may include an inner balloon and an outer balloon, the distal necks of both being turned inward and extending within the inner balloon chamber. The proximal necks may both also be turned inward to extend within the chamber or the proximal neck of the outer balloon may extend away from the balloon chamber.

Abstract: A system and device for cryoablation of tissue that is suitable for use within an MRI environment. The device may include an elongate body, a treatment element at the distal portion of the elongate body, and one or more pull fibers. The pull fibers may be composed of a non-ferromagnetic material, such as a polymer. Likewise, none of the other device components may be composed of a ferromagnetic material. The device may also include at least one fiber optic sensor. The elongate body distal portion may include a distal tip to which the pull fibers are directly coupled. Additionally or alternatively, the elongate body may include one or more pull fiber lumens configured to allow the pull fibers to deflect the distal portion when a pull force is exerted on the pull fibers.

Abstract: An intravascular ablation device, including a flexible elongate body; an expandable element positioned on the elongate body; a radiofrequency or electroporation treatment segment located distally of the expandable element; a cryogenic coolant source in fluid communication with an interior of the expandable element; and a radiofrequency or electroporation energy source in communication with the radiofrequency or electroporation treatment segment.

Abstract: A method of treating or preventing acute respiratory distress syndromes (ARDS) includes advancing a cryogenic treatment element into a target bronchus of a mammal and exchanging cryogenic energy between the target bronchus and the cryogenic treatment element for a predetermined period of time until a target temperature of the target bronchus is reached to cause neuropraxia of nerves within the target bronchus.

Abstract: A method of ablating tissue includes positioning a treatment device proximate to a target tissue area. The treatment device has an expandable treatment element. The expandable treatment element is inflated with a refrigerant during an inflation phase such that at least a portion of the expandable treatment element is in contact with the target tissue area. A first pressure measurement of the inflated expandable treatment element is recorded and compared to a predetermined pressure threshold. The refrigerant is circulated within the expandable treatment element during an ablation phase to reduce a temperature of the target tissue area to a temperature sufficient to cryoablate the target tissue area. A second pressure measurement of the expandable treatment element is recorded during the ablation phase and compared to the predetermined pressure threshold.

Abstract: A method, system, and device for predicting lesion quality. Specifically, lesion quality may be predicted based on an assessment of pulmonary vein occlusion using injection of an impedance-modifying agent and evaluation of changes in impedance measurements recorded by an electrode located distal to an occlusion element of the treatment device used to inject the impedance-modifying agent. The quality of the occlusion may be rated based on the changes in impedance over time within the pulmonary vein. For example, the quality of the occlusion may be rated as being good, fair, or poor. This assessment may be quickly and easily communicated to an operator.

Abstract: A method of performing bronchial denervation of a bronchus having bronchial nerves along a portion thereof is provided. The method includes providing a cryoablation device having multiple electrodes capable of delivering electrical energy and measuring impedance. At least one bronchial nerve is stimulated with electrical energy. The electrical signals from the at least one bronchial nerve are recorded to provide a first value representative of nerve function. Cryogenic treatment energy is applied to form ice in the bronchus having a thickness to encapsulate the at least one bronchial nerve to cause a reduction in nerve function. The at least one bronchial nerve is restimulated with electrical energy. The electrical signals are recorded from the restimulated at least one bronchial nerve to provide a second value that represents diminished nerve function. The first value and the second value are compared to provide an assessment of the reduction in nerve function.

Abstract: A medical device having a catheter and a fluid delivery conduit entirely disclosed within a portion of the catheter. The catheter may have a thermally transmissive region in fluid communication with the fluid delivery conduit and a rod disposed within at least a portion of the fluid delivery conduit. The medical device may control variable fluid flow with the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Additional configurations provided herein may allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: A medical device including an outer tube, an expandable chamber coupled to the outer tube, and an injection tubular member in fluid communication with an interior of the expandable chamber. The injection tubular member is coupled to a source of fluid and a distal end within the expandable chamber and a fluid nozzle is located in a distalmost end face of the distal end of the injection tubular member. A fluid dispersion unit is coupled to the injection tubular member with a longitudinal axis, the fluid nozzle being within the fluid dispersion unit and configured to direct a flow of fluid into the fluid dispersion unit. The fluid dispersion unit has an opening to direct a flow path of the flow of fluid expelled by the fluid nozzle within the fluid dispersion unit and into an interior surface of the expandable chamber from the opening at the distalmost end face.

Abstract: A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.

Abstract: Systems and methods for controllably variable fluid flow are disclosed that provide the ability to modify the effective cross-sectional area of the fluid delivery conduit available for fluid flow. Accordingly, selective control of these configurations allows fluid flow to be regulated as desired while the fluid delivery pressure remains the same. Additional configurations provided herein allow for the selective manipulation of a footprint or therapeutic pattern achievable with the medical device during a single procedure, negating the need for the removal and insertion of multiple devices to achieve the same variations in treatment geometry or characteristics.

Abstract: 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.

Abstract: A method of treating or preventing ARDS includes advancing a cryogenic treatment element into a target bronchus of a mammal and exchanging cryogenic energy between the target bronchus and the cryogenic treatment element for a predetermined period of time until a target temperature of the target bronchus is reached to cause neuropraxia of nerves within the target bronchus.