Abstract: An animated electrophysiology map is generated from a plurality of data points, each including measured electrophysiology information, location information, and timing information. The electrophysiology and location information can be used to generate the electrophysiology map, such as a local activation time, peak-to-peak voltage, or fractionation map. Animated timing markers can be superimposed upon the electrophysiology map using the electrophysiology, location, and timing information. For example a series of frames can be displayed sequentially, each including a static image of the electrophysiology map at a point in time and timing markers corresponding to the state or position of an activation wavefront at the point in time superimposed thereon. The visibility or opacity of the timing markers can be adjusted from frame to frame, dependent upon a distance between the timing marker and the activation wavefront, to give the illusion that the timing markers are moving along the electrophysiology map.

Abstract: A catheter has a body including a proximal region, a neck region, and a distal region. A shaping wire is disposed within the distal region to predispose it into at least a partial loop, which may have a fixed or variable radius of curvature. The shaping wire includes a distal portion having a circular transverse cross-sectional shape and a proximal portion having a non-circular (e.g., rectangular) transverse cross-sectional shape. The proximal portion of the shaping wire can have a width-to-thickness ratio of at least about 4, such as about 4.67. A transition portion can promote a gradual transition from the circular to the non-circular transverse cross-sectional shape, for example by increasing a width of the shaping wire by about 0.001? and/or by decreasing a thickness of the shaping wire by about 0.001? for every about 0.004? in length through the transition portion.

Abstract: An apparatus for in vitro testing of medical device thrombogenicity includes an enclosure; a heating element thermally coupled to the enclosure; and a temperature feedback circuit operably coupled to the heating element and configured to control the heating element to maintain an interior of the enclosure within a preset temperature range. Positive, negative, and intermediate control rods are provided as standards against which to compare a medical device test article. Multiple blood test loops can be established through the enclosure using a common blood supply. The medical device test article can be placed in one of the loops, while the remaining loops can contain controls. Blood can be circulated through the test loops at a flow rate similar to that encountered in vivo, and thrombus formation can be assessed thereafter.

Abstract: A medical device includes a body and at least one electrode disposed thereon. The electrode includes a metallic substrate, such as a platinum group metal, an alloy of platinum group metals, or gold. The surface of the substrate is modified in a manner that increases its effective surface area without inducing bulk heating. For example, the surface of the substrate can be laser textured and/or coated, such as with titanium nitride or iridium oxide.

Abstract: The present disclosure is directed to merging data acquired from differently configured catheters on a common map. In use, physical characteristics of catheters influence recorded electrical signals/responses such that differently configured catheters (e.g., different electrode sizes, shapes, materials, spacings, etc.) may record different responses to measurements taken at the same location in response to the same excitation signal. To allow merging of data from differently configured catheters in a common map, the present disclosure applies a corrective coefficient or transfer function to the recorded electrical signals of one or both catheters to counter-balance variable influences of catheter specific characteristics on recorded signals.

Abstract: Systems and methods for generating and displaying an electrophysiology (EP) map are provided. A system includes a device including at least one sensor configured to collect a set of location data points, and a computer-based model construction system coupled to the device and configured to generate a geometry surface model from the set of location data points, associate an EP parameter with each of a plurality of points on the geometry surface model to generate an EP map, calculate a confidence metric for the EP parameter associated with each point, and display the EP map based on the calculated confidence metrics.

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: Aspects of the present disclosure are directed to flexible high-density mapping catheters with a high-density array of mapping electrodes. 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: 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 irrigated high density electrode catheter can comprise a catheter shaft. The catheter shaft can include a proximal end and a distal end and can define a catheter shaft longitudinal axis. A flexible tip portion can be located adjacent to the distal end of the catheter shaft. An irrigated coupler can be disposed on the distal end of the catheter shaft and can be configured to discharge fluid over the flexible tip portion.

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 loading assembly for crimping and loading a prosthetic heart valve into a delivery device includes a loading base, a base funnel, and a compression member. The loading base has a support and a body extending from the support with a recess defined within the body. The recess is configured to receive a substantial portion of the annulus section of the heart valve in an at least partially collapsed condition. The base funnel is configured to be coupled to the loading base and to at least partially collapse the annulus section of the heart valve as it is inserted into the recess in the loading base. The compression member is configured to be coupled to the loading base with the heart valve inserted in the recess for further collapsing the heart valve and loading it into the delivery device.

Abstract: Various embodiments of the present disclosure can include flexible catheter tip. The flexible catheter tip can include an inboard understructure that defines a tip longitudinal axis, wherein the inboard understructure can be formed from a first continuous element that includes afirst rectangular cross-section. An intermediate inboard covering can be disposed about the first continuous element that forms a distal portion of the inboard understructure. An outboard understructure can extend along the tip longitudinal axis, wherein the outboard understructure can be formed from a second continuous element that includes a second rectangular cross-section. An intermediate outboard covering can be disposed about the second continuous element that forms a distal portion of the outboard understructure.

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.

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 and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Abstract: The present disclosure provides improved medical delivery devices for delivering a medical device into a subject. In one embodiment, the medical delivery device includes a non-porous composite inner layer constructed of a lubricious material having a plurality of pores and a thermoplastic elastomer reflowed into the plurality of pores. In other embodiments, the medical delivery device further includes a thermoplastic elastomer coated braided metallic member surrounding the nonporous composite inner layer to provide strength and structure to the device.

Abstract: The present disclosure provides a medical device comprising an actuator restraining assembly configured to assist in restraining a catheter shaft in a deflected configuration. The actuator restraining assembly may include a brake element, a release element, a connecting sheath, and a connecting rod disposed in a catheter handle, wherein the connecting sheath and connecting rod are attached to an actuator mechanism, and wherein the at brake element is attached to the connecting sheath and the release element is attached to the connecting rod. The brake element is sized and configured to contact an inner wall of the handle to thereby provide resistance to movement of actuator mechanism in a proximal direction with respect to the handle. In one embodiment, the actuator restraining assembly is configured to allow for temporary, i.e., reversible, restraining of the catheter shaft in the deflected configuration.

Abstract: A delivery device for a collapsible heart valve includes an operating handle and a catheter assembly. The operating handle includes a frame defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, and a coupler having locked and unlocked conditions, the coupler being operatively connected to the carriage assembly for movement therewith. The catheter assembly includes a shaft around which a valve-receiving compartment is defined, the shaft being operatively connected to one of the frame or the carriage assembly, and a distal sheath operatively connected to the carriage assembly for movement therewith between a closed condition adapted to maintain the valve in the compartment and an open condition adapted to fully deploy the valve.

Abstract: A ventricular partitioning device for isolating damaged tissue within a ventricle of the heart is disclosed. The ventricular partitioning device includes a disk-shaped portion configured to isolate a portion of a ventricular wall to facilitate remodeling of the ventricular wall. The device further includes an anchor configured to secure the device to the ventricular wall.

Abstract: Flexible high-density mapping catheter tips and flexible ablation catheter tips with onboard high-density mapping electrodes are disclosed. These tips can be used for diagnosing and treating cardiac arrhythmias. The flexible, distal tips are adapted to conform to tissue and comprise a plurality of microelectrodes mounted to permit relative movement among at least some of the microelectrodes. The flexible tip portions may comprise a flexible framework forming a flexible array of microelectrodes (for example, a planar or cylindrical array) adapted to conform to tissue and constructed at least in part from nonconductive material in some embodiments. The flexible array of microelectrodes may be formed from a plurality of rows of longitudinally-aligned microelectrodes. The flexible array may further comprise, for example, a plurality of electrode-carrying arms or electrode-carrier bands. Multiple flexible frameworks may be present on a single device.