Abstract: The present disclosure generally relates to medical devices and methods for navigating a catheter shaft into the body of a subject during an intracoronary or other medical procedure and controlling the distal end of the catheter shaft. The present disclosure includes the use of an introducer positioning device that may be used in combination with an introducer. The introducer positioning device when used in combination with an introducer allows a catheter shaft to be inserted therethrough and into the introducer shaft located in the introducer where a distal end of the catheter shaft is aligned with the distal end of the introducer shaft.

Abstract: Elongate medical devices with a deflectable shaft section include a lumen liner configured to enhance planarity control of the deflectable shaft section. An elongate medical device includes a deflectable shaft section, a lumen within the deflectable shaft section, and a lumen liner that surrounds and defines the lumen. The lumen liner has an in-plane bending stiffness and an out-of-plane bending stiffness that is greater than the in-plane bending stiffness to provide planarity control of the deflectable shaft section during the cross-sectional bending of the deflectable shaft section.

Abstract: Electrical activation of tissue can be mapped from using electrophysiological data from a plurality of electrodes carried by a high density grid catheter. Each clique of three or more electrodes will define a pair of orthogonal bipoles as well as several unipoles. An electroanatomical mapping system can analyze the electrophysiological data such that, for each clique, an integral of an omnipolar electrogram the best morphologically matches a representative (e.g., average) unipolar electrogram for the clique is identified. The orientation of the best-fit omnipole is then defined as the activation direction for the clique. The conduction velocity magnitude can also be computed as a ratio of an amplitude of the unipolar electrogram for the clique to an amplitude of the integral of the omnipolar electrogram for the clique along the activation direction. The resulting activation map can also be output graphically.

Abstract: A prosthetic tricuspid heart valve system includes a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor includes a support structure having a waisted central portion, and atrial and ventricular flared portions sized to clamp a native valve annulus. Atrial and ventricular sheets are coupled to the atrial and ventricular flared portions, and each include a central aperture. A generally cylindrical fabric valve-receiving member has an inflow end coupled to the atrial sheet and an outflow end coupled to the ventricular sheet to provide a conduit through the valve-receiving member between the atrial and ventricular sheet. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame.

Abstract: A prosthetic heart valve includes a stent extending in a longitudinal direction and having a collapsed condition and an expanded condition. The stent includes a plurality of struts forming cells and a plurality of commissure attachment features spaced apart in an annular direction of the stent and extending in a medial direction of the stent. A valve assembly is secured to the commissure attachment features, the valve assembly including a cuff and a plurality of leaflets, each of the leaflets having a free edge and being capable of alternating between an open position and a closed position. A method of manufacturing the prosthetic heart valve is also provided.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, the stent being formed of a plurality of struts forming cells. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets and a cuff. At least one runner is coupled to a cell and configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition.

Abstract: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal to the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

Abstract: The instant disclosure relates to electrophysiology catheters for tissue ablation within a cardiac muscle, for example. In particular, the instant disclosure relates to an electrophysiology ablation balloon catheter with a combination of coated and uncoated surfaces for focusing ablation energy at a desired portion of tissue.

Abstract: A prosthetic heart valve includes a radially collapsible and expandable stent, a cuff and leaflets sutured thereto. The heart valve extends axially between an inflow end and an outflow end and the stent includes a layout of struts and nodes having a hybrid combination of vertical struts and oblique struts in the form of diamond-shaped and half diamond-shaped cells. The layout of the structure is configured to preserve a low cell density of material used in the stent to reduce the stent profile while in a collapsed state and to improve the deployment accuracy of the stent into the native valve annulus.

Abstract: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

Abstract: A prosthetic heart valve may include an expandable stent having a plurality of struts forming cells connected to one another in a plurality of annular rows around the stent, a cuff attached to an annulus section of the stent by cuff sutures that have a plurality of stitches extending through material of the cuff and looping around the struts, and a plurality of leaflets each having a belly attached to the cuff within an interior region of the stent. The leaflets may together have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. The belly of each leaflet may be attached to the cuff by leaflet sutures extending in a path that crosses some of the struts in overlap zones. Those struts may be devoid of the stitches within the overlap zones.

Abstract: The present disclosure provides electroporation systems, methods of controlling electroporation systems to limit electroporation arcs through intracardiac catheters, and catheters for electroporation systems. One method of controlling an electroporation system including a direct current (DC) energy source, a return electrode connected to the DC energy source, and a catheter connected to the DC energy source is disclosed. The catheter has a at least one catheter electrode. The method includes positioning the return electrode near a target location within a body and positioning the catheter electrode adjacent the target location within the body. A system impedance is determined with the return electrode positioned near the target location and the catheter electrode positioned within the body. The system impedance is adjusted to a target impedance to arcing from the catheter electrode.

Abstract: A medical device for treating a native heart valve may include a frame formed of shape-memory material, the frame including a central bar extending between a first leg and a second leg of the frame. The frame may be transitionable between a delivery condition and a deployed condition. The first leg and the second leg may each having a curved portion with a concave outer surface in the deployed condition. The concave outer surface may be sized and shaped to engage a corresponding native commissure of the native heart valve so that, when the frame is deployed within the native heart valve, the central bar bridges across the native heart valve.

Abstract: A location of a number of fiducial points can be computed. The fiducial points can include impedance locations of an electrode disposed on a catheter in an impedance based coordinate system and magnetic locations of a magnetic position sensor disposed on the catheter in a magnetic based coordinate system. The impedance location of the electrode in the impedance based coordinate system can be transformed into a transformed impedance location of the electrode in the magnetic based coordinate system. A magnetic location of the electrode in the magnetic based coordinate system can be determined. A determination of whether an impedance shift exists between the transformed impedance location of the electrode in the magnetic based system and the magnetic location of the electrode in the magnetic based system can be made. An electromagnetic dynamic registration can be generated between the impedance based coordinate system and the magnetic based coordinate system based on the impedance shift.

Abstract: An apparatus for cooling tissue or a fluid for an elongate medical device comprising an elongate shaft extending along a longitudinal axis and comprising a shaft proximal end and a shaft distal end; a support structure located at the shaft distal end, where the support structure is expandable from a contracted state to an expanded state, and a plurality of thermoelectric elements, wherein the thermoelectric elements are located on the support structure. A medical device comprising a first catheter end shape, a second catheter end shape located distally with respect to the first catheter end shape, a support structure that extends between the first and the second catheter end shape, and a plurality of thermoelectric elements. A system for cooling a tissue or a fluid for an elongate medical device, comprising a plurality of thermoelectric elements, a thermocouple, an electronic control unit (ECU).

Abstract: A catheter configured to deliver therapeutic energy to a tissue can include can include an elongate shaft extending along a shaft longitudinal axis and comprising a shaft proximal end and a shaft distal end. The catheter can include a flexible tip assembly comprising a tip assembly outer surface, wherein the flexible tip assembly is connected to the shaft distal end and is configured to deliver therapeutic energy to the tissue, and wherein the flexible tip assembly further includes. The flexible tip assembly can include an insulative layer comprising an insulative layer outer surface, wherein the insulative layer is disposed on the tip assembly outer surface and a mapping electrode disposed on the insulative layer outer surface.

Abstract: Aspects of the instant disclosure relate to an elongated medical device. In particular, the instant disclosure relates to apparatuses for sensing contact force. In various embodiments, a force sensing element including a tip and a catheter shaft, wherein the tip is configured to move relative to the shaft when an external force is applied to the tip comprising a transmitter configured to transmit a transmitter signal when external force is applied to the tip, a first plurality of sensors and a second plurality of sensors positioned proximate the transmitter, wherein each of the sensors is configured to receive the transmitter signal and the first plurality of sensors is longitudinally offset from the second plurality of sensors.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts. A cuff may be coupled to the stent so that a flat, bottom edge of the cuff lies adjacent the proximal end of the stent. A pattern of stitches may be circumferentially disposed around the flat bottom edge of the cuff, the pattern of stitches alternating between stitches sewn to the cuff only and stitches sewn to both the cuff and the stent.

Abstract: A delivery cable for delivering a medical device and a delivery device including the same are described herein. The delivery cable includes a flexible inner core, an outer coil surrounding at least a portion of the flexible inner core, and a pull wire disposed between the flexible inner core and the outer coil, the pull wire configured to deflect a distal deflectable portion of the delivery cable upon manipulation thereof. Methods of making the delivery cable and methods of using the delivery cable to deploy a medical device are also described herein.

Abstract: A partially-masked electrode includes a conductive material and an insulated coating having an outer surface. The insulated coating defines a contoured opening that exposes or reveals an area of the conductive material, wherein the contoured opening has an upper perimeter at the outer surface of the insulated coating. When the upper perimeter of the insulated surface coating is placed in contact with a tissue of interest, wherein the tissue of interest is proximate a blood pool, the insulated coating creates a seal between the blood pool and the contoured opening so that no blood in the blood pool can contact the conductive material. This seal reduces or eliminates the reception of far field effects in the blood pool by the electrode, making it easier to locate and diagnose unhealthy tissue.