Abstract: This disclosure teaches determining a recommended LAA closure device size based on simulations of deployment of multiple closure devices with the LAA anatomy. Input images of the patient's LAA anatomy are received. Multiple simulations are run providing options of device interaction, closure, and anchoring for multiple anchoring sites and device sizes. Gaps between the simulated deployed devices are analyzed based on leak paths and a recommended closure device size determined based on the simulated gaps.

Abstract: A left atrial appendage closure device may include an expandable framework having a plurality of struts joined at a proximal and distal hub. When the framework is fully constrained in a first position, a first segment of struts extends distally from the distal hub parallel to a central longitudinal axis to a first bend and a second segment of struts extends from the first bend proximally. A first amount of the framework is unconstrained in a second position, where the first segment extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment extends from the first bend proximally and radially outward to a second bend, a third segment of struts extends from the second bend proximally and radially inward to a third bend, and a fourth segment of struts extends from the third bend proximally to within the delivery sheath.

Abstract: An implantable medical device such as but not limited to a left atrial appendage closure (LAAC) device includes an expandable frame that is movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame including a proximal portion, a distal portion and an intervening intermediate portion. The expandable frame includes a plurality of anchors extending about a periphery of the expandable frame. A primary covering extends over the proximal portion of the expandable frame and may interact with the plurality of anchors. A secondary covering extends over part of the expandable frame.

Abstract: An occlusive implant system may include an access device including a handle and an access sheath extending distally therefrom. The access device includes a working lumen extending longitudinally therethrough. A proximal portion of the working lumen defines a garage section and a distal portion of the working lumen extends distally of the garage section. The occlusive implant system may include an occlusive implant device including a delivery sheath configured to be received within the garage section, the delivery sheath having a delivery lumen, a core wire disposed therein, and an occlusive implant releasably attached to the core wire. The garage section has a first inner diameter and the distal portion of the working lumen has a second inner diameter less than the first inner diameter. The delivery sheath has an outer diameter less than the first inner diameter and greater than the second inner diameter.

Abstract: A steerable medical device includes a handle having a handle body and a knob that is rotatable about a knob axis with respect to the handle body. An elongate tool extends from the handle. A steering assembly causes deflection of the tool by rotation of the knob. The steering assembly includes a slider that is housed within the handle body and is translatable within the handle body. The steering assembly further includes a control wire coupled between the slider and the tool. Translation of the slider causes tensioning of the control wire and tensioning of the control wire causes deflection of the tool. The steering assembly further includes a crank assembly coupled between the knob and the slider, to drive translation of the slider by rotation of the knob.

Abstract: A steerable medical device includes a handle having a handle body and a first control assembly that is movable with respect to the handle body. A first cam is housed within the handle body and is coupled to the control assembly. Movement of the control assembly with respect to the handle body drives rotation of the cam with respect to the handle body. A first slider is housed within the handle body and is coupled to the cam. Rotation of the cam drives translation of the slider within the handle body. An elongate tool extends from the handle. A first control wire is coupled between the first slider and the tool. Translation of the first slider causes tensioning of the control wire, and tensioning of the control wire causes deflection of the tool.

Abstract: A handle for a medical device includes a handle body and a knob that is rotatable with respect to the handle body. A first gear is associated with the knob. A slide assembly is housed within the handle body or the knob. The slide assembly includes a first lead screw. A second gear is associated with the slide assembly. A third gear is housed within the handle body or the knob and is coupled between the first gear and the second gear. Rotation of the knob drives rotation of the first gear, rotation of the first gear drives rotation of the third gear, rotation of the third gear drives rotation of the second gear, and rotation of the second gear drives rotation of the lead screw.

Abstract: A handle for a medical device includes a rotatable knob assembly and a slide assembly. The knob assembly is couplable to the slide assembly to drive movement of the slide assembly by rotation of the knob assembly. A slip clutch assembly is between the knob and slide assemblies. The slip clutch assembly includes a first disc and a second disc. The first disc is secured to the knob assembly and is rotatable with the knob assembly. The second disc is configured to transmit rotation to the slide assembly. The first disc and/or the second disc is translatable between a first position and a second position. In the first position, the first and second discs are moved into engagement to couple the rotatable knob to the slide assembly. In the second position, the first and second discs are moved out of engagement to decouple the rotatable knob from the slide assembly.

Abstract: A handle for a medical device includes a rotatable knob assembly and a slide assembly. The knob assembly is couplable to the slide assembly to drive movement of the slide assembly by rotation of the knob assembly. A slip clutch assembly is between the knob and slide assemblies. The slip clutch assembly includes a first disc and a second disc. The first disc is secured to the knob assembly, and is rotatable with the knob assembly. The second disc is configured to transmit rotation to the slide assembly. The first disc and/or the second disc is translatable between a first position and a second position. In the first position, the first and second discs are moved into engagement to couple the rotatable knob to the slide assembly. In the second position, the first and second discs are moved out of engagement to decouple the rotatable knob from the slide assembly.

Abstract: A left atrial appendage closure device may include an expandable framework having a plurality of struts joined at a proximal and distal hub. When the framework is fully constrained in a first position, a first segment of struts extends distally from the distal hub parallel to a central longitudinal axis to a first bend and a second segment of struts extends from the first bend proximally. A first amount of the framework is unconstrained in a second position, where the first segment extends distally from the distal hub parallel to the central longitudinal axis to the first bend, the second segment extends from the first bend proximally and radially outward to a second bend, a third segment of struts extends from the second bend proximally and radially inward to a third bend, and a fourth segment of struts extends from the third bend proximally to within the delivery sheath.

Abstract: An implant for occluding a left atrial appendage may include an expandable framework including a first framework portion and a second framework portion, wherein the expandable framework is configured to shift along a longitudinal axis between a collapsed configuration and an expanded configuration. The second framework portion may be disposed radially inward of the first framework portion in the collapsed configuration. The expandable framework includes a proximal hub and a distal hub. The first framework portion may be fixedly attached to the proximal hub and the distal hub. The second framework portion may be fixedly attached to the proximal hub and the distal hub.

Abstract: An apparatus and method are disclosed for providing feedback for a steerable medical device assembly for deflecting a device, the assembly comprising a control handle comprising an actuation mechanism. The assembly additionally comprises a device coupled to the control handle and operable to be deflected upon actuation of the actuation mechanism, and a feedback mechanism for providing an indication of the deflection of the device, wherein the feedback mechanism is associated with the actuation mechanism for deflecting the device.

Abstract: Example occlusive implants are disclosed. An example occlusive implant includes an expandable framework configured to shift between a collapsed configuration and an expanded configuration, an occlusive member disposed along at least a portion of the expandable framework and a first collar attached to the expandable framework. The occlusive implant also includes a sensor housing coupled to the first collar, the sensor housing having a first end and a second end opposite the first end and a second collar slidably disposed along an outer surface of the sensor housing. Further, the second collar is coupled to the expandable framework via a spring. The occlusive implant also includes a sensor disposed along the second end of the sensor housing.

Abstract: An apparatus and method are disclosed for providing feedback for a steerable medical device assembly for deflecting a device, the assembly comprising a control handle comprising an actuation mechanism. The assembly additionally comprises a device coupled to the control handle and operable to be deflected upon actuation of the actuation mechanism, and a feedback mechanism for providing an indication of the deflection of the device, wherein the feedback mechanism is associated with the actuation mechanism for deflecting the device.

Abstract: A snap-fit cover is configured to snap fit to a dilator hub. The snap-fit cover is also configured to snap fit to the sheath-hub cap of the sheath hub.

Abstract: A method and apparatus are disclosed for a reinforced steerable sheath assembly that is usable with an actuator comprising a shaft section defining a sheath that is operable to be deflected, and one or more pull wires that are coupled to the sheath via a coupling at a point of contact between the pull wires and the sheath. The pull wires being operable to be coupled to the actuator for actuating the pull wires. The reinforced steerable sheath assembly further comprises a means for preventing displacement of the coupling, wherein the means for preventing displacement to minimize failure at the coupling at the point of contact between the pull wires and the sheath upon actuation of the pull wires upon actuation of the actuator to deflect the sheath.

Abstract: A method and apparatus are disclosed for a reinforced steerable sheath assembly that is usable with an actuator comprising a shaft section defining a sheath that is operable to be deflected, and one or more pull wires that are coupled to the sheath via a coupling at a point of contact between the pull wires and the sheath. The pull wires being operable to be coupled to the actuator for actuating the pull wires. The reinforced steerable sheath assembly further comprises a means for preventing displacement of the coupling, wherein the means for preventing displacement to minimize failure at the coupling at the point of contact between the pull wires and the sheath upon actuation of the pull wires upon actuation of the actuator to deflect the sheath.

Abstract: A method and apparatus are disclosed for a modified tip for a sheath assembly that provides enhanced radiopacity while maintaining the distal tip profile to maintain adequate tip stiffness and tip transition force. The disclosed method and apparatus provide a distal tip segment for a sheath assembly comprising a region of increased wall thickness along a portion or section of the distal tip segment, providing increased cross-sectional area there-along to provide enhanced radiopacity, and a distal most section of the distal tip segment having a reduced or minimal profile to provide an atraumatic tip while maintaining sufficient stiffness for crossability. The distal tip segment is operable to be coupled to a proximal shaft portion of the sheath assembly, to provide enhanced radiopacity while maintaining the distal tip profile to maintain adequate tip stiffness.

Abstract: An apparatus and method are disclosed for providing feedback for a steerable medical device assembly for deflecting a device, the assembly comprising a control handle comprising an actuation mechanism. The assembly additionally comprises a device coupled to the control handle and operable to be deflected upon actuation of the actuation mechanism, and a feedback mechanism for providing an indication of the deflection of the device, wherein the feedback mechanism is associated with the actuation mechanism for deflecting the device.