Abstract: An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising a balloon inflatable portion with a first length configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion, a balloon proximal portion with a second length, a balloon distal portion with a third length, wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.

Abstract: Various embodiments of the present disclosure can include a medical device for providing therapy to heart tissue. The medical device can comprise a balloon, a movable manifold, wherein the movable manifold comprises a first plurality of openings and the movable manifold is inside the balloon and the movable manifold is configured to distribute a fluid within the balloon, an elongate shaft with a proximal end portion and a distal end portion, wherein the distal end portion of the elongate shaft is coupled with the balloon, a central lumen, wherein the movable manifold is movably coupled with the central lumen, and a supply lumen comprising a supply lumen proximal end and a supply lumen distal end, wherein the supply lumen is longitudinally movable and in fluid communication with the movable manifold, wherein the movable manifold is configured to move longitudinally in response to an actuation of the supply lumen proximal end.

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 end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. 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 substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.

Abstract: A method of generating a map of a portion of a patient's anatomy using an electroanatomical mapping system includes separating an anatomical region (e.g., the heart) into an inclusion region (e.g., the left atrium) and an exclusion region (e.g., the left ventricle) by defining a boundary surface (e.g., along the mitral valve). A label electrode carried by a multi-electrode catheter can be defined and used to determine whether or not to add an electrophysiology data point collected using the multi-electrode catheter to the map. In particular, electrophysiology data points can be added to the map of the portion of the patient's anatomy when they are collected with the label electrode within the inclusion region. Positions of the label electrode can also be used to define the boundary surface. Alerts can also be provided when the label electrode crosses the boundary surface and enters the exclusion region.

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: The present disclosure is directed to interleaving electrical noise generating operations with impedance measurements in a medical localization system. The systems and methods continuously and simultaneously provide unique frequency drive signals, which are harmonics of a common base frequency, across electrode patches to generate an electrical field. Response signals electrodes in the electric field are measured and synchronously demodulated. A demodulated data stream is then filtered (e.g., decimated) to generate impedance-based values proportional to the location of the electrode for each unique frequency. The demodulated data stream into the filter is paused to allow operation of an electrical noise generating device such a magnetic field-based localization system. More specifically, the data stream is paused for a time period equal to an integer multiple of a base period of the common base frequency. This allows resuming filtering of the demodulated data stream free of any frequency discontinuity.

Abstract: A heart prosthesis system may include a prosthetic heart valve and a length of suture. The prosthetic heart valve may include a collapsible and expandable stent and a valve assembly mounted within the stent. The stent may have an aortic end, an annulus end, and a plurality of openings arranged circumferentially around the aortic end, the aortic end having a first diameter in an expanded condition. The length of suture may be threaded through the openings such that tension applied to the length of suture in a direction away from the stent may collapse the aortic end of the stent from the first diameter to a second diameter less than the first diameter.

Abstract: A prosthetic heart valve includes a non-collapsible annular frame extending in a longitudinal direction between an inflow edge and an outflow edge, and a valve assembly connected to the frame. The frame includes a plurality of annularly spaced commissure posts adjacent the outflow edge, each of the commissure posts including a tip and a post slot spaced apart from the tip. The prosthetic heart valve further includes a radiopaque element including an elongated main body having a first end and a second end. The radiopaque element may extend around the tip and through the post slot of at least one of the commissure posts so that a portion of the main body extends between the slot and the tip. Alternatively or additionally, a radiopaque element may be positioned adjacent a base of the frame.

Abstract: Aspects of the present disclosure are directed to flexible high-density mapping catheters with a planar array of high-density mapping electrodes near a distal tip portion. These mapping catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes, and may be used to diagnose cardiac conditions, such as cardiac arrhythmias for example.

Abstract: Various embodiments of the present disclosure can include a flexible catheter tip. The flexible catheter tip can comprise an inboard understructure that defines a tip longitudinal axis, wherein the inboard understructure is formed from a first continuous element that includes a first rectangular cross-section. In some embodiments, an outboard understructure can extend along the tip longitudinal axis, wherein the outboard understructure is formed from a second continuous element that includes a second rectangular cross-section.

Abstract: An electrode assembly includes an electrode pair including a first electrode and a second electrode configured to be selectively energized for delivery of electroporation therapy. The electrode assembly also includes an expandable isolation member disposed axially between the first electrode and the second electrode. One of the first electrode and the second electrode is positioned proximally of a proximal end of the expandable isolation member and the other of the first electrode and the second electrode is positioned distal to a distal end of the expandable isolation member. The expandable isolation member is configurable between a collapsed configuration and an expanded configuration. The expandable isolation member includes a circumferential sealing surface configured for sealing engagement with tissue of a patient such that the expandable isolation member inhibits fluid and electrical communication between the first electrode and the second electrode when engaged with the tissue.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use 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: The present invention provides an improved vascular occlusion device having improved flexibility and retention of the type fabricated from braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site and shaped to create an occlusion of an abnormal opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained. The device further including at least one disk portion adjacent a body cylindrical portion formed from the fabric and having a transition diameter between the disk and cylindrical portion, significantly smaller than the diameter of the disk and the diameter of the cylindrical portion.

Abstract: A collapsible medical device and methods for deploying the same are provided. The medical device includes a tubular metal fabric, which includes a plurality of braided metal strands and a proximal end and a distal end, the tubular metal fabric having a collapsed configuration for delivery and an expanded preset configuration for creating an occlusion of an opening. In the expanded preset configuration, the device has two expanded disk portions and a central portion, a first expanded disk portion and the central portion connected by a first reduced diameter portion, and a second expanded disk portion and the central portion connected by a second reduced diameter portion. Each of the first and second reduced diameter portions is smaller in diameter than both the two expanded disk portions and the central portion, and each of the first and second reduced diameter portions is recessed into the central portion.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having an inflow end and an outflow end, and a plurality of struts defining a plurality of cells, the stent being formed of a first material, a plurality of commissure attachment features formed of a second material that is different than the first material of the stent, and a collapsible and expandable valve assembly including a plurality of leaflets connected to the plurality of commissure attachment features.

Abstract: A system for determining electrophysiological data comprising an electronic control unit configured to acquire electrophysiology signals from a plurality of electrodes (130) of one or more catheters, select at least one clique of electrodes from the plurality of electrodes (136) to determine a plurality of local E field data points, determine the location and orientation of the plurality of electrodes, process the electrophysiology signals from the at least one clique from a full set of bipole subcliques to derive the local E field data points associated with the at least one clique of electrodes, derive at least one orientation independent signal from the at least one clique of electrodes (138) from the information content corresponding to weighted parts of electrogram signals, and display or output catheter orientation independent electrophysiologic information to a user or process.

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: Described herein is a medical device for treating a target site, the medical device including, a proximal end including a disc and a distal end including a lobe. The disc and the lobe are connected by a connecting member. The lobe includes a proximal portion defining a proximal surface of the lobe, a distal portion defining a distal surface of the lobe, and a middle portion connecting and extending between the proximal portion and the distal portion. A first transition between the proximal portion and the middle portion is curved, and a second transition between the middle portion and the distal portion is curved. The medical device also includes a plurality of stabilizing wires coupled to the lobe at a radially outer surface of the middle portion, each stabilizing wire including a hook portion extending radially outward from the at least one lobe.

Abstract: In some examples, a delivery device includes a handle, a catheter sheath defining a lumen and extending distally from the handle, and a hemostasis valve positioned at least partially within the handle, the hemostasis valve being located proximal the catheter sheath, the hemostasis valve including a first seal and a second seal, and a first flush-port disposed between the first seal and the second seal.