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 method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.

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 collapsible and expandable prosthetic atrioventricular valve may include an outer stent, an inner stent, and a plurality of prosthetic leaflets mounted within the inner stent. The outer stent may have an atrial disc, a ventricular disc, and a plurality of posts coupling the atrial disc to the ventricular disc. A plurality of connectors may extend between the inner stent and the outer stent to couple the inner stent to the outer stent. The outer stent may be devoid of metal in a space circumferentially extending between adjacent ones of the plurality of posts. The space may extending approximately one half, approximately one third, or approximately one fourth of a circumference of the outer stent.

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.

Abstract: Embodiments of the present disclosure include a medical device. The medical device can include a catheter shaft that includes a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. A flexible tip portion can be located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework, wherein the flexible framework is curved about a transverse framework axis that is disposed transverse to the catheter shaft longitudinal axis without application of a force external to the medical device. A plurality of microelectrodes can be disposed on the flexible framework and can form a flexible array of microelectrodes adapted to conform to tissue.

Abstract: An integrated electrode structure can comprise a catheter shaft comprising a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. A flexible tip portion can be located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework. A plurality of microelectrodes can be disposed on the flexible framework and can form a flexible array of microelectrodes adapted to conform to tissue. A plurality of conductive traces can be disposed on the flexible framework, each of the plurality of conductive traces can be electrically coupled with a respective one of the plurality of microelectrodes.

Abstract: A catheter includes an elongate shaft, an electrode assembly, a connective stem, a coupler, a first magnetic position sensor, and a second magnetic position sensor. The electrode assembly includes microelectrodes. The connective stem includes a first connective stem member and a second connective stem member. The connective stem defines a first sensor receptacle and a second sensor receptacle in an exterior surface of the connective stem. The coupler is configured for coupling with the connective stem. The first magnetic position sensor is disposed in the first sensor receptacle and elongated along a first sensor longitudinal axis. The second magnetic position sensor disposed in the second sensor receptacle and elongated along a second sensor longitudinal axis that is not parallel to the first sensor longitudinal axis.

Abstract: A catheter with three distinct compression resistance coils, including a body coil and two pull wire coils, is disclosed. The triple coil system can provide maximal resistance to compression of the catheter's proximal shaft, as well as maximization of the curve angle that the catheter tip can achieve. Additionally, the tri-coil catheter can allow for a lower initial compression load and a more flexible proximal shaft. A gap between the outer diameter of the pull wire and the inner diameter of the pull wire compression coil that is equal to about 10-30% of inner diameter of the pull wire compression coil can provide optimal catheter performance.

Abstract: A system and method measures impedance across a plurality of electrodes and assesses proximity or contact between electrodes of a medical device and patient tissue. Contact is assessed between individual electrodes and cardiac tissue using bipolar electrode complex impedance measurements. Initially, baseline impedance values are established for each of the individual electrodes based on the responses of the electrodes to the applied drive signals. After establishing the baseline impedance values a series of subsequent impedance values are measured for each electrode. For each electrode, each subsequent impedance value may be compared to a previous baseline impedance value for that electrode. If a subsequent impedance value is less than the baseline impedance value for a given electrode, the baseline impedance value may be reset to the subsequent impedance value. Such systems and method are particularly applicable to medical devices having numerous electrodes.

Abstract: A system and method measures impedance across a plurality of electrodes and assesses proximity or contact between electrodes of a medical device and patient tissue. Contact is assessed between individual electrodes and cardiac tissue using bipolar electrode complex impedance measurements. Initially, baseline impedance values are established for each of the individual electrodes based on the responses of the electrodes to the applied drive signals. After establishing the baseline impedance values a series of subsequent impedance values are measured for each electrode. For each electrode, each subsequent impedance value may be compared to a previous baseline impedance value for that electrode. If a subsequent impedance value is less than the baseline impedance value for a given electrode, the baseline impedance value may be reset to the subsequent impedance value. Such systems and method are particularly applicable to medical devices having numerous electrodes.

Abstract: A delivery device for an implantable medical device having a retention member at an end thereof may include a shaft extending in a longitudinal direction and defining a longitudinal axis, an elongated sheath surrounding a longitudinal portion of the shaft, a compartment defined inside the sheath and adapted to receive the medical device in an assembled condition, a retainer positioned at one end of the compartment, and an energy storage element positioned on the longitudinal portion of the shaft and configured to be radially compressed by the medical device when the elongated sheath covers the compartment containing the medical device. The sheath may be slidable relative to the shaft in the longitudinal direction. The retainer may include a recess adapted to receive the retention member of the medical device in the assembled condition.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending along a longitudinal axis and having an inflow end and an outflow end, the stent including a plurality of cells annularly arranged around the stent in at least one row, the plurality of cells having a first nesting cell adjacent the outflow end of the stent, a first engaging arm disposed within the first nesting cell and being pivotally movable between a loaded condition, a partially-released condition, and a fully-released condition, the first engaging arm and the first nesting cell having a synchronous pivoting movement, and a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets.

Abstract: A method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.

Abstract: Embodiments of the present invention provide an improved vascular occlusion device for occlusion of a passageway, cavity, or the like. According to one embodiment, a medical device for occluding a left atrial appendage is provided. The medical device includes a first portion having at least one plane of occlusion that is configured to be positioned outside of the left atrial appendage, and a second portion having at least one plane of occlusion that is configured to be at least partially positioned within a cavity defined by the left atrial appendage.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent with a valve assembly disposed therein. A first cuff is positioned on the lumenal or ablumenal surface of the stent. A second cuff is positioned radially outward of the stent and the first cuff. The second cuff may include apertures that allow blood to pass through the second cuff into the spaces between the first and second cuffs. The second cuff may include a proximal edge with a plurality of notches that may be closed to create puckered areas in the second cuff to facilitate the movement of blood in the spaces between the first and second cuffs. The stent may include struts adjacent the second cuff that bow radially inwardly to create additional space for blood to flow in the spaces between the first and second cuffs.

Abstract: The signal quality of an electrophysiological signal can be determined from information regarding proximal stability of an electrophysiology catheter at the time the signal is acquired and temporal stability of the electrophysiological signal. The proximal stability information can include a distance between the electrophysiology catheter and an anatomical surface, a velocity of the electrophysiology catheter, and/or contact force between the electrophysiology catheter and the anatomical surface. Graphical representations of signal quality scores can be output to a display in order to enable visualization thereof by a practitioner.

Abstract: Disclosed herein is a catheter tip sized and configured to fit onto a distal end of a catheter shaft, the catheter shaft having a shaft outer diameter. The catheter tip includes a base, a tip having an arcuate shape, an outer surface extending from the base to the tip along a longitudinal axis, the outer surface having a diameter at the base that is substantially equal to the shaft outer diameter, and an inner surface extending from the base, wherein the inner surface defines a first region having a first diameter and a second region having a second diameter, wherein the second diameter is less than the first diameter, and wherein the second region is distal of the first region and configured to receive at least one component extending beyond the distal end of the catheter shaft.

Abstract: Systems and methods for identifying potential ablation sites using electrical parameter data are provided. A method includes geometrically isolating an arrhythmogenic substrate in a three-dimensional geometry. The method further includes generating a first cumulative map from a first dataset including electrical parameter data for each vertex in the isolated arrhythmogenic substrate, and generating a second cumulative map from a second dataset including additional data for each vertex. The method further includes generating a third cumulative map from the first and second cumulative maps, and displaying the third cumulative map on the three-dimensional geometry to facilitate identifying potential ablation sites.