Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: The present disclosure provides electroporation systems and methods of energizing a catheter for delivering electroporation. A catheter for delivering electroporation includes a distal section and an electrode assembly. The distal section is configured to be positioned in a vein within a body. The vein defines a central axis. The electrode assembly is coupled to the distal section and includes a structure and a plurality of electrodes distributed thereabout. The structure is configured to at least partially contact the vein. Each of the electrodes is configured to be selectively energized to form a circumferential ring of energized electrodes that is concentric with the central axis of the vein.

Abstract: A delivery device 100 includes a catheter assembly 120 and an operating handle 130. The operating handle 130 may include a nose 131 affixed to the catheter assembly 120, an axial shaft 180, a base 132 translationally fixed to a proximal end of the axial shaft, a screw 160 having external threads and a non-circular lumen 161, the axial shaft extending through the non-circular lumen, a proximal end 171 of a pull wire 170 being affixed to the screw, a knob 150 having internal threads engaged with the external threads of the screw, and a collar 140 extending at least partially around the axial shaft. When the collar 140 is in a proximal position, rotation of the knob 150 may deflect the distal end 121 of the catheter assembly 120. When the collar is in a distal position, rotation of the knob 150 may rotate the catheter assembly 120.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending in a longitudinal direction between an inflow end and an outflow end, the stent including a plurality of struts defining a plurality of cells, and a plurality of commissure attachment features disposed on the stent, each commissure attachment feature having a first end, a second end opposite the first end, and at least two bodies connected via one or more suspension struts, each of the at least two bodies having at least one eyelet.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Abstract: A prosthetic heart valve having a cuff attached to a stent provides a seal for preventing paravalvular leakage. The cuff may be constructed from known sealing materials to fill in and around paravalvular leakage gaps, while continuously collapsing down into a low profile volume within the stent. The cuff is coupled circumferentially about the stent by members which may be in the nature of dimension and/or shape memory material having a tensioned and relaxed state. The members may be in the form of elongated elastic members or coiled members. When in the tensioned state, the cuff is located within the stent volume to provide a low profile prosthetic heart valve. Upon relaxing of the members, the cuff is pulled over the abluminal surface of the stent to form a cuff seal circumscribing the stent for preventing paravalvular leakage.

Abstract: A holder for a prosthetic heart valve includes a base having an annular portion defining an aperture, and a spool rotatably mated with the base. The spool has a platform and a head extending in a longitudinal direction from the platform. The holder further includes a button housing having an aperture sized and shaped to receive the head of the spool, and a button inserted in the button housing. The button housing is detachably coupled to the spool in an assembled condition. The button is movable relative to the button housing to move the button housing from a condition locked to the spool to a condition removable from the spool.

Abstract: A steerable sheath includes an inner liner extending from a proximal end to a distal end of the steerable sheath. The inner liner includes a non-deflectable portion and a deflectable portion. The steerable sheath includes a first pull wire positioned along a first helical path around the circumference of the inner liner from a proximal end to a distal end of the non-deflectable portion of the inner liner and along a first straight path from a proximal end of the deflectable portion to a distal end of the deflectable portion. The steerable sheath includes a second pull wire positioned along a second helical path around the circumference of the inner liner from the proximal end to the distal end of the non-deflectable portion and along a second straight path from the proximal end of the deflectable portion to the distal end of the deflectable portion.

Abstract: Embodiments of the present invention provide medical devices and methods for treating a target site within the body. For example, one embodiment provides a stent graft for treating a target site proximate to a bifurcated lumen, wherein the stent graft includes a first tubular structure having proximal and distal ends and a side wall extending therebetween. The first tubular structure includes an opening defined within the side wall and is configured to define a first portion having first and second ends and a second portion having first and second ends. The opening corresponds to the first ends of the first and second portions and the second ends of the first and second portions respectively correspond to the proximal and distal ends of the first tubular structure, and at least a portion of the first and second portions are configured to be positioned within respective branches of a bifurcated lumen.

Abstract: A prosthetic heart valve for replacing a native valve includes a stent, a valve assembly, and a radiopaque element. The stent has a plurality of commissure attachment features. The valve assembly includes a plurality of leaflets and first and second cuffs. The first cuff has a proximal edge relatively close to the inflow end of the stent. The second cuff may be annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The proximal edge of the first cuff is coupled to the proximal edge of the second cuff substantially continuously along a circumference of the inflow end of the stent so that a pocket is formed between the first cuff and the second cuff. The radiopaque element is disposed within the pocket and aligned in a longitudinal direction of the stent with at least one of the plurality of commissure attachment features.

Abstract: A prosthetic heart valve may include a stent, a valve assembly disposed within the stent, a flange, and a plurality of anchor arms coupled to the stent. The stent may have collapsed and expanded conditions and inflow and outflow ends. The flange may include a plurality of braided wires and may be coupled to the stent and may be positioned adjacent the inflow end of the stent in the expanded condition of the stent. Each anchor arm may have a first end coupled to the stent adjacent the outflow end of the stent, a second end coupled to the stent adjacent the outflow end of the stent, and center portions extending from the first and second ends toward the inflow end of the stent. The center portions may be joined together to form a tip pointing toward the inflow end of the stent in the expanded condition of the stent.

Abstract: An apparatus for stabilizing a prosthetic heart valve within an atrioventricular valve includes a collapsible and expandable stent having an inflow end, an outflow end, and struts forming a plurality of cells connected to one another in a plurality of annular rows around the stent. The stent further includes a collapsible and expandable valve assembly secured to the stent. The valve assembly includes a cuff and a plurality of leaflets having an open configuration and a closed configuration. A cord connected to the stent includes an attachment device adapted to couple the stent to heart tissue of a patient. A method of stabilizing a prosthetic heart valve within an atrioventricular valve annulus is also described.

Abstract: A collapsible stent for an implantable prosthetic valve incorporates leaflet-supporting members having relatively large surface area in comparison to other members defining the remainder of the stent. The leaflet-supporting members may have openings extending through them. The valve leaflets may be attached to the stent so that an attached edge of each leaflet extends along the leaflet-supporting members and is attached to the members by polymer integral with the leaflet overlying the leaflet supporting members and extending into the openings of the leaflet supporting members. The secure attachment resists stress on the leaflets.

Abstract: A plurality of electrophysiological signals measured by a respective plurality of electrodes carried by a multi-dimensional catheter can be sorted relative to a direction of interest, such as a cardiac activation wavefront direction. An electroanatomical mapping system can be used to determine the orientation of the multi-dimensional catheter relative to the direction of interest. For example, the user can manually adjust the orientation by manipulating a slider, a wheel, or a similar graphical user interface control. As another example, the user can draw a presumed orientation on a geometric model. Once the orientation is determined, the system can sort the plurality of electrophysiological signals and output a graphical representation of the sorted plurality of electrophysiological signals, for example as a plurality of traces.

Abstract: A grip for inhibiting travel of a prosthetic valve loading tube along an outer shaft of a delivery catheter system has a lumen extending therethrough. A portion of the lumen has a variable internal diameter for selective frictional engagement with the outer shaft. In some arrangements, the variable internal diameter is provided by variable compression of a gasket aligned on the lumen. In other arrangements, the variable internal diameter is provided by a portion of the grip that surrounds the lumen and that has at least one circumferential gap of variable width.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent includes a plurality of cells, each cell being formed by a plurality of struts, and a plurality of commissure features. The heart valve further includes a valve assembly secured to the stent and including a cuff and a plurality of leaflets, each leaflet being attached to adjacent commissure features and to the stent struts and/or the cuff.

Abstract: A collapsible prosthetic heart valve includes a collapsible and expandable stent and a collapsible and expandable valve assembly. The stent has a proximal end and a distal end. A plurality of commissure points is disposed on the stent. The valve assembly is disposed within the stent and includes a plurality of leaflets. Each leaflet has a free edge. An end portion of the free edge of each leaflet is folded and sutured to a corresponding one of the plurality of the commissure points.

Abstract: A collapsible and expandable stent body includes a generally tubular annulus section, one or more prosthetic valve elements mounted to the stent body, and a cuff attached to the stent body. The prosthetic valve is operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction. The prosthetic heart valve may include paravalvular leak mitigation features in the form of first and second sealing members. The sealing members are attached to the cuff and extend circumferentially around an abluminal surface of the stent body. The sealing members each have an open side facing in a first axial direction and a closed side facing in an opposite second axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing members and cause the sealing members to billow outwardly relative to the stent body, helping to mitigate paravalvular leak.