Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body carried by the frame. The device may have a thromboresistant cover at a proximal end and a thromboresistant coating on the foam body. The frame may have recapture struts inclining radially outwardly in the distal direction from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame to engage tissue. The anchors can also be reversible to allow retraction of the anchors and repositioning or retrieval of the device.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. The device may have a thromboresistant cover at a proximal end. The frame may have recapture struts inclining radially outwardly from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame and into the foam to engage tissue.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. The device may have a thromboresistant cover at a proximal end. The frame may have recapture struts inclining radially outwardly from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame and into the foam to engage tissue.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body carried by the frame. The device may have a thromboresistant cover at a proximal end and a thromboresistant coating on the foam body. The frame may have recapture struts inclining radially outwardly in the distal direction from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame to engage tissue. The anchors can also be reversible to allow retraction of the anchors and repositioning or retrieval of the device.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame having anchors and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. A loader includes a conical portion with guides and a reservoir for submerging the foam implant prior to loading and delivery.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body carried by the frame. The device may have a thromboresistant cover at a proximal end and a thromboresistant coating on the foam body. The frame may have recapture struts inclining radially outwardly in the distal direction from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame to engage tissue. The anchors can also be reversible to allow retraction of the anchors and repositioning or retrieval of the device.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. The device may have a thromboresistant cover at a proximal end. The frame may have recapture struts inclining radially outwardly from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame and into the foam to engage tissue.

Abstract: Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body carried by the frame. The device may have a thromboresistant cover at a proximal end and a thromboresistant coating on the foam body. The frame may have recapture struts inclining radially outwardly in the distal direction from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame to engage tissue. The anchors can also be reversible to allow retraction of the anchors and repositioning or retrieval of the device.

Abstract: The present invention provides an apparatus and method for a torque limiting wrench used for applying a torque to a medical device to prevent damage to the medical device by providing a predetermined torque limit to indicate when the predetermined torque is reached. The torque limiting wrench comprises a gripping mechanism for engaging a medical device, a handle extending from the gripping mechanism and a torque limiting assembly contained within a length of the handle. A predetermined torque is set by the torque limiting assembly to provide an indicator to prevent damage to the acoustic characteristics of the medical device. The torque limiting wrench comprises a material that can undergo a sterilization process.

Abstract: The present invention provides an apparatus and method for a torque limiting wrench used for applying a torque to a medical device to prevent damage to the medical device by providing a predetermined torque limit to indicate when the predetermined torque is reached. The torque limiting wrench comprises a gripping mechanism for engaging a medical device, a handle extending from the gripping mechanism and a torque limiting assembly contained within a length of the handle. A predetermined torque is set by the torque limiting assembly to provide an indicator to prevent damage to the acoustic characteristics of the medical device. The torque limiting wrench comprises a material that can undergo a sterilization process.

Abstract: An apparatus and a method for using a vascular introducer with an ultrasonic probe to remove a debris from a graft, fistula, vessel, port, or other vascular access device. The vascular introducer for insertion into a vascular access device includes an elongated shaft having a distal end and a proximal insertion end; an anchoring mechanism that resides within the elongated shaft when the anchoring mechanism is in a retracted position and extends beyond the proximal insertion end of the elongated shaft and engages an inner surface of the vascular access device when the anchoring mechanism is in an extended position; and an activation mechanism that moves the anchoring mechanism from the retracted position to the extended position. The vascular introducer may further include a rotation mechanism that allows the vascular introducer to change direction within the vascular access device without being removed from the vascular access device.

Abstract: The invention is directed to a container for storage, dispensation, transport and disposal of a medical device such a disposable ultrasonic surgical probe, that allows its dispensation for use, and for its safe storage and disposal after use, thereby protecting the user from the hazards of needle pricks and possible contamination from small-diameter probes. The container of the present invention also provides a mechanism for restricting access to the probe to prevent its reuse, and a method for its safe attachment to and detachment from an ultrasonic medical device. The container comprises a cylindrical tube having two ends and an inner surface defining a space for containing the probe.

Abstract: The invention is directed to a container for storage, dispensation, transport and disposal of a medical device such a disposable ultrasonic surgical probe, that allows its dispensation for use, and for its safe storage and disposal after use, thereby protecting the user from the hazards of needle pricks and possible contamination from small-diameter probes. The container of the present invention also provides a mechanism for restricting access to the probe to prevent its reuse, and a method for its safe attachment to and detachment from an ultrasonic medical device. The container comprises a cylindrical tube having two ends and an inner surface defining a space for containing the probe.