Abstract: Described herein is a patch delivery assembly for treating a target site and a method for deploying the same. The patch delivery assembly includes a patch installation frame having a self-expanding body extending between a proximal end and an open distal end and defining a lumen therethrough. The patch delivery assembly also includes a delivery cable having a distal end coupled to the proximal end of the patch installation frame and further defining the lumen, and a securement device extending through the lumen defined through the delivery cable and the patch installation frame, the securement device terminating in a distal working end including a securement mechanism. In a deployment configuration of the patch delivery assembly, the patch delivery assembly further includes a patch releasably coupled to the distal end of the patch installation frame, for securement to tissue of the target site using the securement mechanism.

Abstract: The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Abstract: The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Abstract: A method of closing a patent foramen ovale (PFO) including a septum primum and septum secundum is implemented using a suture device including an operational shaft housing an anchor assembly, a needle assembly, and a suture. The method includes advancing an end of the operational shaft to a proximal side of the PFO, positioning a distal portion of the end of the operational shaft on a distal side of the PFO, and actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO. The method also includes actuating the needle assembly on the proximal side of the PFO to deploy the needle assembly through the PFO and the anchor assembly, thereby deploying the suture through the PFO. The method further includes retracting the anchor assembly into the operational shaft, and withdrawing the distal portion of the operational shaft from the PFO, leaving the deployed suture.

Abstract: The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Abstract: Described herein is a medical device including a medical device including a device body and a plurality of extensions. The device body includes a first side, a second side, and a plurality of expandable cells. The plurality of expandable cells have a proximal edge and a distal edge. The plurality of expandable cells extends laterally between and connects the first and second sides. The plurality of extensions extend longitudinally from each of the first and second sides. A first plurality of extensions extend proximally from a proximal end of each side to beyond the proximal edge and a second plurality of extensions extend distally from a distal end of each side to beyond the distal edge. The first and second pluralities of extensions have coiled ends.

Abstract: Described herein is an electrode assembly for a catheter system, and methods of using and forming the same. The electrode assembly includes an inner electrode basket having a first proximal end, a first distal end, and a first plurality of struts. The electrode assembly also includes an outer electrode basket having a second proximal end, a second distal end, and a second plurality of struts. The first proximal end is positioned within and coaxial with the second proximal end, and the first distal end is positioned within and coaxial with the second distal end such that the inner electrode basket is positioned within and coaxial with the outer electrode basket. The inner electrode basket is angularly offset from the outer electrode basket such that the first plurality of struts and the second plurality of struts alternate about a circumference of the electrode assembly.

Abstract: A medical device includes a first end, a second end, and a central segment proximate a middle of the medical device and about which the medical device is symmetrical. The medical device also includes a pair of inner reverse bends spaced from the central segment by a first body plane extending from the central segment to the pair of inner reverse bends in a first longitudinal direction, and a pair of outer reverse bends. The outer reverse bends are spaced from the pair of inner reverse bends by a second body plane extending from the pair of inner reverse bends to the pair of outer reverse bends in a second, opposite longitudinal direction, and the outer reverse bends are spaced from the first and second ends of the medical device by a third body plane extending in the first direction from the outer reverse bends to the first and second ends.

Abstract: An introducer with a steerable distal tip section is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: A patent foramen ovale (PFO) tunnel filler medical device including device anchors coupled to and extending outwardly from a filler portion of a device frame that has a generally planar shape configured to fill a PFO tunnel, and a delivery system including the same are described herein. The medical device includes a fabric layer and the device anchors are configured to extend outwardly from the device frame.

Abstract: An introducer with a steerable distal tip section is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Abstract: An introducer with a steerable distal tip section is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: An introducer (10) with a steerable distal tip section (17) is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: Soft body tissue structure can be remodeled by shortening the distance between first and second portions of that tissue structure. First and second anchor structures are respectively implanted in the first and second portions of the tissue structure. These anchor structures are linked by a linking structure, the length of which between the anchor structures can be shortened to pull the tissue structure portions toward one another. Each of the anchor structures may include two screw structures that are driven into the associated tissue structure portion transverse to the linking structure and with a spacer between the two screws. The entire prosthesis can be implanted percutaneously if desired. An illustrative use of the prosthesis is to shorten the annulus of a patient's mitral valve, with at least a portion of the prosthesis implanted in the patient's coronary sinus.

Abstract: An introducer (10) with a steerable distal tip section (17) is disclosed. The steerable distal tip section may comprise an articulation support member comprising a laser-cut pattern of symmetrical elongated apertures in which the shape of each aperture is defined by at least three radii, a central radii being the largest and two end radii being smaller. This pattern of apertures can minimize ovaling of the cross-sectional shape of introducer shaft over the length of the deflectable section. The introducer can articulate in multiple planes. A tension pull wire can allow the introducer to resist directional bias.

Abstract: A prosthetic mitral valve includes a collapsible and expandable elliptical or “D”-shaped stent. The stent includes first and second commissure attachment features and a collapsible and expandable valve assembly disposed therein. The valve assembly includes two leaflets, each leaflet having a first edge operably coupled to the stent and a second free edge. Each leaflet may include first and second tabs connecting first and second ends of the first and second edges, respectively. Each leaflet includes a height measured from a midpoint of the first edge to a midpoint of the second edge and a width measured from a junction of the first edge with the first tab to a junction of the first edge with the second tab. The ratio of the height to the width may be between about 0.4 and about 0.65.

Abstract: An implant structure for use in pulling two soft body tissue areas closer together in a patient (e.g., two points along or adjacent to the patient's mitral valve annulus) includes at least two tissue anchor structures that are respectively implantable into the two tissue areas. A tether structure links the two tissue anchors and can be shortened and held in that condition by a cinch structure. Bracing structures are used between the anchors and the tether to help keep the longitudinal axes of the anchors transverse to the tether axis even when the tether is under tension. The tether may be sheathed in a cushioning sleeve to help protect adjacent tissue from erosion by the tether.

Abstract: Apparatus is provided that can be delivered through a catheter to a remote location in a patient's body. The apparatus may include a first structure that can be positioned in all dimensions in a controlled manner and stabilized in that desired position, a second structure that can then position a lumen axis at a desired angle relative to the first structure, and a third member that can pass through the lumen and approach and engage with force (e.g., penetrate) a desired location on the anatomy without compromising maintaining the desired position. The apparatus effectively separates the forces needed for positioning and the forces needed for tissue engagement (e.g., penetration).

Abstract: A structure that can be used to provide an anchor in or adjacent to a patient's soft body tissue (rather than bone) includes an annular array of flexible members that extend between two axially spaced but aligned tubular members. The space between the tubular members can be selectively changed to affect the amount by which portions of the flexible members between the tubular member project radially outward relative to the tubular members. When the flexible members project radially out, the structure resists axial movement relative to adjacent tissue and therefore acts as an anchor. When the flexible members do not project radially out, they permit axial movement of the structure through adjacent tissue.