Abstract: A flexible electrode includes a flexible, electrically insulative substrate, a bonding layer disposed on a first surface of the substrate, a conductive layer disposed on a second surface of the substrate, and a via through the bonding layer and the substrate that exposes a portion of the reverse surface of the conductive layer. The exposed portion of the reverse surface can be secured (e.g., soldered) to a conductive contact, such as a conductive pill, on an exterior surface of a catheter shaft. The flexible electrode can then be wrapped around the exterior surface of the shaft to form a ring electrode and the bonding layer can be bonded to the catheter shaft, such as by reflow bonding.

Abstract: A transseptal catheterization apparatus includes an electrically-conductive core, an energy delivery element at the distal end of the core, a coil or insulative filler surrounding at least a portion of the core, and an insulative jacket surrounding at least a portion of the core. The coil may be radially adjacent the core with the insulative jacket surrounding the coil. Alternatively, the insulative jacket may be radially adjacent the core and the coil may surround the insulative jacket. The energy delivery element may be a tip electrode conductively coupled to the core. An insulative bushing may be positioned between the tip electrode and the coil to electrically isolate the tip electrode from the coil. The exterior surface(s) of the energy delivery element and/or the coil may be dimpled or roughened.

Abstract: A pull wire assembly for a steerable medical device includes a wire lock and a wire. The lock includes a core having a frustoconical outer surface and an annular collar including a frustoconical inner surface complementary to the outer surface of the core. The core is inserted into the collar. The wire is inhibited against distal movement by a compressive force arising within the wire lock when the frustoconical surfaces of the core and collar are forced against each other. The wire may be inserted into the lock between the collar and the core, such that it is pinned therebetween. Alternatively, the wire may be inserted through an interior of the core, such that it is pinned between pieces of the core, such as a plurality of tines or two halves of the core.

Abstract: A steerable introducer deflectable via a handle assembly is described. The handle assembly includes slide members disposed within a slide chassis and coupled to deflection wires to deflect the introducer, and a slide block divider for constraining slide members. The slide block divider and the slide chassis combine to form a slide compartment in which each of the first slide member and the second slide member is slidably disposed. The slide block divider can prevent the deflection wires from crossing each other within the handle assembly, and constrain each of the slide members during translation within the slide compartment to inhibit motion transverse to a longitudinal direction of the slide compartment. The slide block divider can provide an improved handling of the steerable introducer.

Abstract: A steerable introducer deflectable via a handle assembly is described. The handle assembly includes slide members disposed within a slide chassis and coupled to deflection wires to deflect the introducer, and a slide block divider for constraining slide members. The slide block divider and the slide chassis combine to form a slide compartment in which each of the first slide member and the second slide member is slidably disposed. The slide block divider can prevent the deflection wires from crossing each other within the handle assembly, and constrain each of the slide members during translation within the slide compartment to inhibit motion transverse to a longitudinal direction of the slide compartment. The slide block divider can provide an improved handling of the steerable introducer.

Abstract: An electrical connector includes a plug portion and a receptacle portion. The plug portion includes a plurality of conductive pins, with a portion of each conductive pin surrounded by a non-conductive post. The receptacle portion includes a plurality of conductive pins recessed into a corresponding plurality of recesses within the receptacle portion. When the plug portion is mated to the receptacle portion, the conductive pins of the plug portion are received within the recesses of the receptacle portion and electrically connected to the conductive pins of the receptacle portion. To advantageously increase creepage and clearance between pins, it is desirable for each recess to have a depth sufficient to receive both a conductive pin and a corresponding surrounding non-conductive post when the plug portion is mated to the receptacle portion.

Abstract: A deflectable catheter assembly including a handle, a catheter system, a method for determine deflection of a deflectable shaft section of the catheter. The catheter includes a handle coupled for deflecting the deflectable shaft section, and one or more pull wires to effect a deflection. The handle includes a housing, a deflection control coupled to the housing and operable to deflect the deflectable shaft section, and a deflection feedback assembly (e.g., a variable resistor) disposed within the housing. The deflection feedback assembly is coupled to the deflection control and configured to convert motion of the deflection control into a signal indicative of a degree of deflection of the deflectable shaft section. The deflection feedback assembly provides an active feedback regarding deflection of the deflectable shaft section to facilitate accurate positioning of the deflectable shaft section within a patient.

Abstract: A flexible electrode includes a flexible, electrically insulative substrate, a bonding layer disposed on a first surface of the substrate, a conductive layer disposed on a second surface of the substrate, and a via through the bonding layer and the substrate that exposes a portion of the reverse surface of the conductive layer. The exposed portion of the reverse surface can be secured (e.g., soldered) to a conductive contact, such as a conductive pill, on an exterior surface of a catheter shaft. The flexible electrode can then be wrapped around the exterior surface of the shaft to form a ring electrode and the bonding layer can be bonded to the catheter shaft, such as by reflow bonding.

Abstract: Described is a steerable catheter assembly including an elongated catheter shaft with a steerable section that can be articulated to navigate the catheter shaft through a tortuous path through a patient's vasculature. The steerable section includes a planarity member(s) disposed within and fixedly attached (e.g., row of holes extending along a length of the planarity member). The planarity member extend along the centerline of the steerable section. The planarity member has a cross-sectional area perpendicular to the centerline. The cross-sectional area has a maximum principal area moment of inertia of at least 5 times a minimum principal area moment of inertia. The catheter shaft also includes a deflection lumen offset from the planarity member, and a pull wire disposed within the deflection lumen and operable to induce deflection of the elongated catheter shaft section.

Abstract: A magnetic position sensor for tracking a position of a medical device. The magnetic position sensor includes a magnetically permeable core. The magnetically permeable core has a longitudinal axis and a first flat surface extending parallel with the longitudinal axis. A coil including a conductive wire is wrapped around the longitudinal axis of the magnetically permeable core in a plurality of windings.

Abstract: Disclosed herein is an electroporation system including a catheter shaft, at least one electrode coupled to the catheter shaft at a distal end thereof, and an electroporation generator coupled in communication with the at least one electrode. The electroporation generator configured to supply a biphasic pulse signal to the at least one electrode. The biphasic pulse signal includes a first phase having a first polarity and a first pulse duration, and a second phase having a second polarity opposite to the first polarity, and a second pulse duration. Each of the first phase and second phase has a voltage amplitude of at least 500 volts and a pulse duration of less than 20 microseconds. The second phase is generated at a non-zero interval following the first phase.

Abstract: A catheter (e.g., a deflectable electrophysiology catheter) includes a shaft, a tip electrode, and a coupler joining the tip electrode and the shaft. The coupler includes a cylindrical body having an annular wall defining a central cavity, a plurality of vias extending through the annular wall into the central cavity, a pull wire receptacle, and a sensor receptacle. A pull wire is connected at its distal end to the coupler within the pull wire receptacle; a sensor (e.g., a localization sensor) is secured within the sensor receptacle. Ring electrodes may be positioned around the coupler; corresponding conductors may be routed therefrom, through the vias, and into the central cavity.

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: An apparatus for transseptal catheterization includes a dilator with an energy delivery element attached to its distal end. The energy delivery element is configured to deliver sufficient energy to a tissue, such as the fossa ovalis, adjacent the distal end to permit the dilator to penetrate the tissue and cross into the left atrium. The energy delivery element can be a radiofrequency electrode, a pulsed field ablation electrode, an ultrasound transducer, or the like. A guidewire and/or introducer may also be included to facilitate the transseptal catheterization.

Abstract: Embodiments include medical devices comprising a handle assembly including a wire tensioner component and an adjustment knob, the adjustment knob configured to rotate about a longitudinal axis of the handle assembly; an elongate shaft coupled to the handle assembly, the elongate shaft defining a lumen and including a deflectable section; a first wire coupled to the adjustment knob and extending from the adjustment knob through the lumen to at least a distal end portion of the deflectable section; and a second wire coupled to the wire tensioner component and extending from the wire tensioner component to at least the distal end portion of the deflectable section, the second wire having a deflectable extraluminal section configured to deflect independently of the deflectable section.

Abstract: An electrical connector includes a plug portion and a receptacle portion. The plug portion includes a plurality of conductive pins, with a portion of each conductive pin surrounded by a non-conductive post. The receptacle portion includes a plurality of conductive pins recessed into a corresponding plurality of recesses within the receptacle portion. When the plug portion is mated to the receptacle portion, the conductive pins of the plug portion are received within the recesses of the receptacle portion and electrically connected to the conductive pins of the receptacle portion. To advantageously increase creepage and clearance between pins, it is desirable for each recess to have a depth sufficient to receive both a conductive pin and a corresponding surrounding non-conductive post when the plug portion is mated to the receptacle portion.

Abstract: An electroporation catheter includes a shaft having a proximal end and a distal end and an electroporation assembly N located at the distal end of the shaft. The electroporation assembly may include at least a first electrode and a non-conductive portion, the non-conductive portion having a first end and a second end, wherein the first end is connected to the shaft and wherein the second end extends radially outward from the first end.

Abstract: A steerable introducer deflectable via a handle assembly is described. The handle assembly includes slide members disposed within a slide chassis and coupled to deflection wires to deflect the introducer, and a slide block divider for constraining slide members. The slide block divider and the slide chassis combine to form a slide compartment in which each of the first slide member and the second slide member is slidably disposed. The slide block divider can prevent the deflection wires from crossing each other within the handle assembly, and constrain each of the slide members during translation within the slide compartment to inhibit motion transverse to a longitudinal direction of the slide compartment. The slide block divider can provide an improved handling of the steerable introducer.

Abstract: Systems and methods for electroporation are provided. An electroporation system includes a catheter including a plurality of electrodes, and a pulse generator coupled to the catheter, the pulse generator configured to generate a waveform to be delivered using at least one of the plurality of electrodes. The waveform includes a first pulse having a first polarity, a first pulse amplitude, and a first pulse width, and a second pulse having a second polarity, a second pulse amplitude, and a second pulse width, wherein the first and second pulses are separated by an interpulse delay, and wherein at least one of i) the first pulse amplitude is different than the second pulse amplitude and ii) the first pulse width is different than the second pulse width.

Abstract: Systems and methods for electroporation catheters are disclosed herein. An electroporation catheter includes a shaft, and a plurality of splines forming a basket around a distal portion of the shaft, each spline extending between a proximal end that is coupled to the shaft and a distal end that is coupled to the shaft, wherein each spline of the plurality of splines comprises at least one energizable electrode. The electroporation catheter further includes a balloon positioned within the basket formed by the plurality of splines, the balloon selectively inflatable to facilitate securing a position of the plurality of splines.