Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A system coupled to a non-human subject comprising communication circuitry configured to communicatively couple to a medical device coupled to the subject and a remote computing system, the medical device configured to monitor physiological data of the non-human subject and the remote computing system configured to store historical data for the non-human subject; processing circuitry; and a memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to: receive the monitored physiological data from the medical device; determine whether the medical device indicates that the monitored physiological data is in satisfaction of at least one condition triggering an upload of at least a portion of the monitored physiological data; and in response to the determination, generate, for communication to the remote computing system, output data comprising the at least a portion of the monitored physiological data.

Abstract: A surgical kit for providing a cryoprotective composition configured to be applied during cryotreatment of a patient includes: a first container containing a predetermined amount or volume of a biodegradable and/or bioerodible fluid agent; and a second container containing a predetermined amount or volume of a non-toxic cryoprotectant agent. The predetermined amount or volume of the of biodegradable and/or bioerodible fluid agent and the predetermined amount or volume of a non-toxic cryoprotectant agent are configured to be mixed together to form the cryoprotective composition in which a therapeutically effective amount of the cryoprotective composition deposited in a body space of the patient in proximity to the cryotreatment remains within at least a portion of the body space for a duration of the cryotreatment and at least a portion of a body tissue proximate to the body space is viable after the cryotreatment.

Abstract: A cryoprotective composition configured to be applied during cryotreatment of a patient includes at least one biodegradable and/or bioerodible fluid agent and at least one non-toxic cryoprotectant agent. A therapeutically effective amount of the cryoprotective composition deposited in a body space of the patient in proximity to the cryotreatment remains within at least a portion of the body space for a duration of the cryotreatment. At least a portion of a body tissue proximate to the body space is viable after the cryotreatment. A method of protecting a surgical site during prostate cryosurgery is also provided. The method includes injecting a therapeutically effective amount of the cryoprotective composition into the body space, wherein the body space is a periprostatic space of a patient.

Abstract: Medical devices for closing anatomical apertures, such as atrial or ventricular septal defects, are disclosed. The medical devices can include a plug body having a proximal end, a distal end, and a longitudinal axis. The plug body can include an exterior surface, an interior surface defining an interior lumen, and a seal which can be located within the interior lumen. The medical devices can also include at least one arm member extending through the plug body between the exterior surface and the interior surface of the plug body. In certain embodiments, the medical device can include a distal loop and a proximal loop extending through the plug body. In certain embodiments, the proximal loop can be smaller than the distal loop, such that a top end and a bottom end of the proximal loop can fit within a top end and a bottom end of the distal loop.

Abstract: A method and system for providing lesion depth feedback during an ablation procedure. In particular, the method and system provide feedback data or information relating to lesion depth in myocardial tissue during a cryoablation procedure. A plurality of tissue temperature measurements may be transmitted from a plurality of thermocouples disposed on a cryotreatment element, which measurements may be used to determine a slope of change in temperature sensed by each thermocouple over time. The circulation of coolant through the treatment element may be adjusted when the slope changes. A change in slope may indicate that the cryoablation temperatures have passed through target myocardial tissue into non-target, non-myocardial tissue, which may result in collateral damage to structures near the heart.

Abstract: Medical devices for closing anatomical apertures, such as atrial or ventricular septal defects, are disclosed. The medical devices can include a plug body having a proximal end, a distal end, and a longitudinal axis. The plug body can include an exterior surface, an interior surface defining an interior lumen, and a seal which can be located within the interior lumen. The medical devices can also include at least one arm member extending through the plug body between the exterior surface and the interior surface of the plug body. In certain embodiments, the medical device can include a distal loop and a proximal loop extending through the plug body. In certain embodiments, the proximal loop can be smaller than the distal loop, such that a top end and a bottom end of the proximal loop can fit within a top end and a bottom end of the distal loop.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for ligating the left atrial appendage without creating pro-arrhythmic tissue. The device may generally include a snare including a thermally transmissive distal portion and a suture including a distal portion, both distal portions having a lasso-shaped configuration that may be positioned proximate the base of the left atrial appendage. Once the distal portions of the snare and the suture are tightened around the base of the left atrial appendage, the thermally transmissive distal portion of the snare may be activated to create an ablation lesion in adjacent left atrial appendage tissue. The lesion may be created with radiofrequency energy or through cryoablation by the circulation of refrigerant within the thermally transmissive distal portion of the snare.

Abstract: A device, system, and method for ligating the left atrial appendage without creating pro-arrhythmic tissue. The device may generally include a snare including a thermally transmissive distal portion and a suture including a distal portion, both distal portions having a lasso-shaped configuration that may be positioned proximate the base of the left atrial appendage. Once the distal portions of the snare and the suture are tightened around the base of the left atrial appendage, the thermally transmissive distal portion of the snare may be activated to create an ablation lesion in adjacent left atrial appendage tissue. The lesion may be created with radiofrequency energy or through cryoablation by the circulation of refrigerant within the thermally transmissive distal portion of the snare.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A method and system for providing lesion depth feedback during an ablation procedure. In particular, the method and system provide feedback data or information relating to lesion depth in myocardial tissue during a cryoablation procedure. A plurality of tissue temperature measurements may be transmitted from a plurality of thermocouples disposed on a cryotreatment element, which measurements may be used to determine a slope of change in temperature sensed by each thermocouple over time. The circulation of coolant through the treatment element may be adjusted when the slope changes. A change in slope may indicate that the cryoablation temperatures have passed through target myocardial tissue into non-target, non-myocardial tissue, which may result in collateral damage to structures near the heart.

Abstract: A method and system for providing lesion depth feedback during an ablation procedure. In particular, the method and system provide feedback data or information relating to lesion depth in myocardial tissue during a cryoablation procedure. A plurality of tissue temperature measurements may be transmitted from a plurality of thermocouples disposed on a cryotreatment element, which measurements may be used to determine a slope of change in temperature sensed by each thermocouple over time. The circulation of coolant through the treatment element may be adjusted when the slope changes. A change in slope may indicate that the cryoablation temperatures have passed through target myocardial tissue into non-target, non-myocardial tissue, which may result in collateral damage to structures near the heart.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: Method and systems of determining adequacy of fixation of a medical lead type having a fixation helix are disclosed. The lead of the medical lead type is placed at a desired location within a patient's body and the fixation helix is screwed into tissue at that location. One or more parameters, associated with the lead, are measured at the location. Based upon the measured one or more parameters, determining a number of turns that the helix is embedded into the tissue at the location.

Abstract: An isolated heart or heart-lung preparation in which essentially normal pumping activity of all four chambers of the heart is preserved, allowing for the use of the preparation in conjunction with investigations of electrode leads, catheters, ablation methods, cardiac implants and other medical devices intended to be used in or on a beating heart. The system can be designed to be used within a Magnetic Resonance Imaging (MRI) unit or a X-ray computed tomography (CT) scanner. The preparation may also be employed to investigate heart and lung functions, in the presence or absence of such medical devices. In order to allow comparative imaging visualizations of either or simultaneously the heart and/or lung structures and devices located within the chambers of the heart or vessels or bronchi within the lungs, a clear perfusate such as a modified Krebs buffer solution with oxygenation is circulated through all four chambers of the heart and thus the coronary and/or pulmonary vasculatures.

Abstract: A device, system, and method for ligating the left atrial appendage without creating pro-arrhythmic tissue. The device may generally include a snare including a thermally transmissive distal portion and a suture including a distal portion, both distal portions having a lasso-shaped configuration that may be positioned proximate the base of the left atrial appendage. Once the distal portions of the snare and the suture are tightened around the base of the left atrial appendage, the thermally transmissive distal portion of the snare may be activated to create an ablation lesion in adjacent left atrial appendage tissue. The lesion may be created with radiofrequency energy or through cryoablation by the circulation of refrigerant within the thermally transmissive distal portion of the snare.

Abstract: Medical devices for closing anatomical apertures, such as atrial or ventricular septal defects, are disclosed. The medical devices can include a plug body having a proximal end, a distal end, and a longitudinal axis. The plug body can include an exterior surface, an interior surface defining an interior lumen, and a seal which can be located within the interior lumen. The medical devices can also include at least one arm member extending through the plug body between the exterior surface and the interior surface of the plug body. In certain embodiments, the medical device can include a distal loop and a proximal loop extending through the plug body. In certain embodiments, the proximal loop can be smaller than the distal loop, such that a top end and a bottom end of the proximal loop can fit within a top end and a bottom end of the distal loop.