Abstract: Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture.

Abstract: Described here are devices and systems for accessing and delivering devices to a heart. The left atrial appendage may be used as an access port to allow pericardial access to internal structures of the heart. Systems that may be used to provide access to the heart via the left atrial appendage may comprise a first access element with a first alignment member, a second access element with a second alignment member, a piercing element, and an exchange element. A piercing element may be advanced to pierce the wall of the left atrial appendage to form an access site therethrough. Optionally, an exchange element may be advanced to initiate a track between the inside and outside of the left atrial appendage, which may be used for device delivery. Some systems may further comprise a left atrial appendage stabilization device.

Abstract: Described here are devices for closing one or more tissues, and handles for controlling these devices. Generally, the devices described here comprise a snare loop assembly, wherein the snare loop assembly comprises a snare and a suture loop, and a handle for controlling the snare loop assembly. In some variations the snare loop assembly may comprise a retention member that may releasably connect the suture loop to the snare. In other variations the devices comprise one or more force-reducing suture locks to help prevent the suture loop from inadvertently disengaging from the snare loop assembly. In still other variations, the excess-suture management features. The handles described here may be configured to remove excess suture from a suture loop, and may also be configured to release the suture loop from the snare loop assembly.

Abstract: Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

Abstract: Described here are devices for closing one or more tissues, and handles for controlling these devices. Generally, the devices described here comprise a snare loop assembly, wherein the snare loop assembly comprises a snare and a suture loop, and a handle for controlling the snare loop assembly. In some variations the snare loop assembly may comprise a retention member that may releasably connect the suture loop to the snare. In other variations the devices comprise one or more force-reducing suture locks to help prevent the suture loop from inadvertently disengaging from the snare loop assembly. In still other variations, the excess-suture management features. The handles described here may be configured to remove excess suture from a suture loop, and may also be configured to release the suture loop from the snare loop assembly.

Abstract: Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture therethrough.

Abstract: Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture.

Abstract: Devices and methods for accessing the pericardial space of a heart are described here. Access devices may generally comprise a tissue-engaging member, a tissue-piercing member, and a guide element. The access device may be introduced to the surface of a pericardium, where the tissue-engaging member may be deployed to engage a portion of the pericardium without engaging the epicardial surface of the heart. Once the access device has engaged the pericardium, the device may manipulate the pericardium to increase the distance between a portion of the pericardium and the epicardial surface of the heart. Once a sufficient space has been created, the tissue-piercing member may be advanced to pierce the pericardium and enter the pericardial space. The guide element may then be introduced into the pericardial space to provide an access pathway to the heart for other devices.

Abstract: Described here are devices and systems for accessing and delivering devices to a heart. The left atrial appendage may be used as an access port to allow pericardial access to internal structures of the heart. Systems that may be used to provide access to the heart via the left atrial appendage may comprise a first access element with a first alignment member, a second access element with a second alignment member, a piercing element, and an exchange element. A piercing element may be advanced to pierce the wall of the left atrial appendage to form an access site therethrough. Optionally, an exchange element may be advanced to initiate a track between the inside and outside of the left atrial appendage, which may be used for device delivery. Some systems may further comprise a left atrial appendage stabilization device.

Abstract: Described here are devices, methods, and systems for accessing and delivering devices to a heart. The left atrial appendage may be used as an access port to allow pericardial access to internal structures of the heart. Systems that may be used to provide access to the heart via the left atrial appendage may comprise a first access element with a first alignment member, a second access element with a second alignment member, a piercing element, and an exchange element. Some systems may further comprise a left atrial appendage stabilization device. Methods of accessing and delivering devices to the heart via the left atrial appendage may comprise advancing a first access element into the left atrial appendage by an intravascular pathway and advancing a second access element towards the left atrial appendage through the pericardial space. The first and second alignment members may form an attachment through the wall of the left atrial appendage so that the first and second access elements are aligned.

Abstract: Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture.

Abstract: Described here are devices and methods for suture management. In some variations, the devices comprise an elongate tubular member having a proximal end, a distal end, a lumen therebetween, a cantilever blade positioned near the distal end of the elongate tubular member, and an expandable member positioned adjacent the cantilever blade for actuating the cantilever blade. Also described are devices comprising an elongate tubular member having a proximal end, a distal end, a lumen at least partially therebetween, and an aperture in a wall thereof for passage of a suture therethrough. These devices further comprise a blade connected to a blade housing disposed within the lumen, where the blade is oriented parallel to the longitudinal axis of the lumen. The blade and blade housing may be slidable within the lumen, or an inner shaft for may be slidable within the lumen. Methods of using the devices are also described.

Abstract: Described here are closure devices and methods for ligating tissue, such as the left atrial appendage, and tensioning devices and mechanism for actuating these devices. The tensioning mechanisms and devices may allow a user to apply one or more predetermined forces to a suture or other portion of the closure devices.

Abstract: Devices and methods for accessing the pericardial space of a heart are described here. Access devices may generally comprise a tissue-engaging member, a tissue-piercing member, and a guide element. The access device may be introduced to the surface of a pericardium, where the tissue-engaging member may be deployed to engage a portion of the pericardium without engaging the epicardial surface of the heart. Once the access device has engaged the pericardium, the device may manipulate the pericardium to increase the distance between a portion of the pericardium and the epicardial surface of the heart. Once a sufficient space has been created, the tissue-piercing member may be advanced to pierce the pericardium and enter the pericardial space. The guide element may then be introduced into the pericardial space to provide an access pathway to the heart for other devices.

Abstract: Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

Abstract: Described here are devices, methods, and systems for accessing and delivering devices to a heart. The left atrial appendage may be used as an access port to allow pericardial access to internal structures of the heart. Systems that may be used to provide access to the heart via the left atrial appendage may comprise a first access element with a first alignment member, a second access element with a second alignment member, a piercing element, and an exchange element. Some systems may further comprise a left atrial appendage stabilization device. Methods of accessing and delivering devices to the heart via the left atrial appendage may comprise advancing a first access element into the left atrial appendage by an intravascular pathway and advancing a second access element towards the left atrial appendage through the pericardial space. The first and second alignment members may form an attachment through the wall of the left atrial appendage so that the first and second access elements are aligned.

Abstract: Described here are devices for closing one or more tissues, and handles for controlling these devices. Generally, the devices described here comprise a snare loop assembly, wherein the snare loop assembly comprises a snare and a suture loop, and a handle for controlling the snare loop assembly. In some variations the snare loop assembly may comprise a retention member that may releasably connect the suture loop to the snare. In other variations the devices comprise one or more force-reducing suture locks to help prevent the suture loop from inadvertently disengaging from the snare loop assembly. In still other variations, the excess-suture management features. The handles described here may be configured to remove excess suture from a suture loop, and may also be configured to release the suture loop from the snare loop assembly.

Abstract: Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture therethrough.

Abstract: Described here are devices, systems and methods for closing the left atrial appendage. Some of the methods described here utilize one or more guide members having alignment members to aid in positioning of a closure device. In general, these methods include advancing a first guide having a first alignment member into the left atrial appendage, advancing a second guide, having a second alignment member, into the pericardial space, aligning the first and second alignment members, advancing a left atrial appendage closure device into the pericardial space and adjacent to the left atrial appendage, and closing the left atrial appendage with the closure device. In these variations, the closure device typically has an elongate body having a proximal end and a distal end, and a closure element at least partially housed within the elongate body. The closure element comprises a loop defining a continuous aperture therethrough.

Abstract: Described here are devices and methods for suture management. In some variations, the devices comprise an elongate tubular member having a proximal end, a distal end, a lumen therebetween, a cantilever blade positioned near the distal end of the elongate tubular member, and an expandable member positioned adjacent the cantilever blade for actuating the cantilever blade. Also described are devices comprising an elongate tubular member having a proximal end, a distal end, a lumen at least partially therebetween, and an aperture in a wall thereof for passage of a suture therethrough. These devices further comprise a blade connected to a blade housing disposed within the lumen, where the blade is oriented parallel to the longitudinal axis of the lumen. The blade and blade housing may be slidable within the lumen, or an inner shaft for may be slidable within the lumen. Methods of using the devices are also described.