Abstract: A method for performing bronchial denervation, the method comprising an electromyography system having a cryoablation device with at least two recording electrodes. The electromyography system being configured to calculate a difference between a first electromyogram signal received from the first recording electrode and a second electromyogram signal received from the second recording electrode to generate a recorded electromyogram and compare the recorded electromyogram to a reference electromyogram.

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: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

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: 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: A system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: The present invention provides a medical device that may include a catheter body having proximal and distal portions, a fluid injection lumen disposed within elongate body, and a guidewire lumen disposed within the elongate body. A tip portion defining a cavity in fluid communication with the fluid injection lumen may be coupled to the distal end of the guidewire lumen, and an expandable element may be coupled to the distal portion of the catheter body and to the tip portion, such that the expandable element is in fluid communication with the fluid injection lumen. A shaping element may at least partially surround the expandable element, where the shaping element is configurable in a first geometric configuration and a second geometric configuration.

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 device and system for providing mapping and treatment capabilities without increasing stiffness of the device. An embodiment of a device may include a flexible elongate body and at least one mapping element on the distal portion of the elongate body. Each mapping element may be an area of thermally conductive material, such as metallic nanoparticles, that is embedded within, integrated with, or deposited on the elongate body. The flexibility of the areas of thermally conductive material is at least substantially the same as that of the elongate body so the device may include many electrodes without compromising flexibility and maneuverability of the device. Alternatively, the device may include a treatment element coupled to the elongate body, such as a balloon. The mapping elements may be embedded within, integrated with, or deposited on the balloon and may have at least substantially the same flexibility as that of the balloon.

Abstract: Devices, systems, and methods for treating pulmonary conditions, such as COPD and asthma, by denervating bronchial tissue using cryoablation. In one embodiment, a device for bronchial denervation comprises: an elongate body having a distal portion and a proximal portion opposite the distal portion; a treatment element at the distal portion of the elongate body; and a first recording electrode located distal to the treatment element and a second recording electrode located proximal to the treatment element, the first and second recording electrodes being configured to record electromyograms. In one embodiment, the device includes a fluid delivery element that is within the treatment element and that has a plurality of orifices aligned with an equatorial portion of the treatment element.

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 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: 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: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

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 system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

Abstract: A system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: The present invention provides a medical device that may include a catheter body having proximal and distal portions, a fluid injection lumen disposed within elongate body, and a guidewire lumen disposed within the elongate body. A tip portion defining a cavity in fluid communication with the fluid injection lumen may be coupled to the distal end of the guidewire lumen, and an expandable element may be coupled to the distal portion of the catheter body and to the tip portion, such that the expandable element is in fluid communication with the fluid injection lumen. A shaping element may at least partially surround the expandable element, where the shaping element is configurable in a first geometric configuration and a second geometric configuration.