Abstract: The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section extends into the tube structure. The tube structure includes a plurality of bypass cuts formed tangentially within the tube structure to increase the flexibility of the tube structure and to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion. The occluder portion includes a hub that defines an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining an occluder eyelet adjacent thereto. The anchor portion extends between a first end and a second end, the first end coupled to an anchor hub and the second end defining an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet. With this arrangement, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

Abstract: Disclosed are guidewire and catheter systems that can be used to facilitate desirable catheter axial response (e.g., pushability) over a guidewire for advancement through patient vasculature. Features of the guidewire and catheter systems enable the catheter to advance over the guidewire within the tortuous paths of a patient's vasculature in response to push forces that do not exceed 50 g.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device coupled to a delivery catheter includes a fluid flow path that facilitates contrast fluid to pass through the delivery catheter and the medical device to a distal side thereof to provide imaging information as to the position of the medical device positioned in the opening, such as the left atrial appendage. In another embodiment, a medical device is coupled to a delivery catheter, the medical device including flaps adjacent a hub of the medical device that close-off a bore of the hub upon the catheter being detached from the medical device.

Abstract: The present disclosure relates to interventional devices such as catheters and guidewire devices having micro-fabricated features for providing flexibility while maintaining good torquability. An interventional device includes an elongated member having an arrangement of fenestrations which define a plurality of axially extending beams coupling a plurality of circumferentially extending rings. The fenestrations are arranged so that the resulting beams form a distributed, non-helical and non-linear pattern along the length of the elongated member. The pattern of fenestrations thereby minimizes or eliminates preferred bending axes.

Abstract: The present disclosure relates to interventional devices such as catheters and guidewire devices having micro-fabricated features for providing flexibility while maintaining good torquability. An interventional device includes an elongated member (500) having an arrangement of fenestrations which define a plurality of axially extending beams coupling a plurality of circumferentially extending rings. The fenestrations are arranged so that the resulting beams form a distributed, non-helical and non-linear pattern along the length of the elongated member. The pattern of fenestrations thereby minimizes or eliminates preferred bending axes.

Abstract: The present disclosure relates to devices and methods for accessing a targeted vessel, such as a coronary artery, near the aortic root. A catheter device includes a proximal section, an intermediate section, and a distal section. The intermediate section includes a more proximal section (a proximal-intermediate section) and a more distal section (a distal-intermediate section). The proximal-intermediate section is microfabricated to enable preferred bending along a single plane. The distal-intermediate section is more rigid than the proximal-intermediate section and the distal section. In use, the proximal-intermediate section abuts against the aortic wall and bends to allow the distal-intermediate section to extend across the aortic root toward a targeted vessel on the opposite side of the aorta.

Abstract: The present disclosure relates to devices and methods for accessing a targeted vessel, such as a coronary artery, near the aortic root. A catheter device includes a proximal section, an intermediate section, and a distal section. The intermediate section includes a more proximal section (a proximal-intermediate section) and a more distal section (a distal-intermediate section). The proximal-intermediate section is microfabricated to enable preferred bending along a single plane. The distal-intermediate section is more rigid than the proximal-intermediate section and the distal section. In use, the proximal-intermediate section abuts against the aortic wall and bends to allow the distal-intermediate section to extend across the aortic root toward a targeted vessel on the opposite side of the aorta.

Abstract: This disclosure describes microfabricated intravascular devices that are configured for high axial strength while also maintaining effective bending flexibility. A tube member includes a series of circumferentially extending rings connected to one another by a series of axially extending beams. Transverse cuts separate and define the rings. A series of axial cuts are aligned with the beams and extend from the beams partially into the adjoining rings so that the beam length is nested partially within the axial length of the adjoining rings. This increases the functional length of the beams to provide bending flexibility while still sufficient ring structure to provide effective axial stiffness.

Abstract: This disclosure describes microfabricated core wires configured for use in an intravascular device such as a guidewire or microcatheter. A microfabricated core wire includes a plurality of disks spaced apart from one another along a length of the distal section and a plurality of longitudinally extending ribbons interposed between the disks, each ribbon extending between and connecting a pair of adjacent disks. Various arrangements of disks and ribbons may be provided to control stiffness across a length of the core wire, particularly at or near the distal tip of the core wire.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion. The occluder portion includes a hub that defines an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining an occluder eyelet adjacent thereto. The anchor portion extends between a first end and a second end, the first end coupled to an anchor hub and the second end defining an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet. With this arrangement, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.

Abstract: Several embodiments are set forth of devices, systems and methods for modifying an atrial appendage such as a left atrial appendage (LAA). In one embodiment, a medical device includes a frame member and a tissue growth member. The frame member includes a unitary, seamless central portion having a plurality of struts defining a multi-cellular structure and an anchoring system, the plurality of struts extending between and configured to self-expand and directly bias the anchor system to anchor the frame member at least partially within the LAA. With this arrangement, the tissue growth member is attached to the frame member to occlude the LAA.

Abstract: The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section extends into the tube structure. The tube structure includes a plurality of bypass cuts formed tangentially within the tube structure to increase the flexibility of the tube structure and to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

Abstract: The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section extends into the tube structure. The tube structure includes a plurality of bypass cuts formed tangentially within the tube structure to increase the flexibility of the tube structure and to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a device includes a framework extending between a primary hub and a secondary hub. The secondary hub is moveable relative to the primary hub upon deploying the framework from a constricted position to a deployed position such that the secondary hub remains proximal a distal end of the framework. The framework, in the deployed position, includes engaging members proximal the distal end of the framework, and the framework includes multiple frame segments each extending with an arcuate configuration at a distal side of the framework such that the frame segments, at the distal side thereof, each extend radially and distally toward the distal end, then turn and extend radially and proximally inward toward the secondary hub.

Abstract: The present disclosure relates to vascular devices such as guidewires and microcatheters having integrated coil sections for optimizing torquability, flexibility, and ability to shape and maintain the distal tip. A guidewire device includes a core and a tube structure coupled to the core such that at least a portion of the core passes into the tube structure. A distal section of the tube structure includes a spiral cut arrangement that configures the distal section as an integral coil integrally incorporated as part of the tube structure. The integrated coil configuration increases the flexibility of the tube structure to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

Abstract: The present disclosure relates to vascular devices such as guidewires and microcatheters having integrated coil sections for optimizing torquability, flexibility, and ability to shape and maintain the distal tip. A guidewire device includes a core and a tube structure coupled to the core such that at least a portion of the core passes into the tube structure. A distal section of the tube structure includes a spiral cut arrangement that configures the distal section as an integral coil integrally incorporated as part of the tube structure. The integrated coil configuration increases the flexibility of the tube structure to reduce the tendency of resilient forces from the tube structure to disrupt a shaped distal tip of the guidewire device.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an anchor portion and an occluder portion. The anchor portion includes frame segments, each anchor frame segment extending between a first end and a second end such that the second end of each anchor frame segment is coupled to an anchor hub. The occluder portion includes a hub that defines an axis. The occluder portion includes multiple occluder frame segments that extend between a proximal end and a distal end such that the proximal end of the occluder frame segments are pivotably coupled to the hub and the distal end of the occluder frame segments are pivotably coupled to the first end of the anchor frame segments.