Abstract: An ablation electrode assembly is provided with improved irrigation cooling of the assembly and ablation site. The assembly includes a proximal end configured to be coupled to a catheter shaft and a distal end configured to deliver ablation energy to tissue. The assembly further includes a fluid manifold extending from the proximal end to the distal end and configured to fluidly communicate with a fluid lumen in the catheter shaft. The fluid manifold defines an axial passageway centered about a longitudinal axis extending in the longitudinal direction of the assembly. The axial passageway has a distal end terminating prior to the distal end of the electrode assembly. The assembly further includes means for creating turbulence in fluid exiting the first axial passageway.

Abstract: The invention provides a deflectable catheter capable of forming many variable radius spiral forms from a single, flexible, distal end section. In one aspect, the catheter employs a variable radius control wire to extend or deform a pre-formed loop structure into a three dimensional spiral-like form or geometry. The ability of a single catheter to create a multitude of shapes and sizes allows users to access to a number of anatomical areas without changing the catheter during a procedure or treatment. In another aspect, the invention encompasses methods of producing deflectable variable radius catheters, where two or more regions of the catheter having common control wires are fused or formed onto one another.

Abstract: A magnetically-guided catheter includes a tip positioning magnet in the distal electrode assembly configured to interact with externally applied magnetic fields for magnetically-guided movement. A magnetically-guided mapping catheter includes an electrically-conductive capsule in the form of a casing that includes a distal ablation surface and isolates the positioning magnet from bio-fluids to prevent corrosion. An open irrigation ablation catheter includes an isolated manifold that isolates the positioning magnet from contact with irrigation fluid to prevent corrosion.

Abstract: An embodiment of a method for solving the inverse problem of electrophysiology and determining a voltage distribution on a surface of a tissue may comprise receiving a plurality of voltages collected by a plurality of electrodes adjacent to the surface, discretizing the problem using a Finite Element Method (FEM) or a Boundary Element Method (BEM), introducing one or more regularization terms to an error minimization formulation, and solving, by a processor, the voltage distribution according to the plurality of voltages and according to the regularization terms. The regularization terms may comprise one or more of a Laplacian smoothness operator, a Tikhonov regularization matrix, a confidence matrix, and a linear operator that interpolates the plurality of electrode voltages to the tissue voltage distribution.

Abstract: A catheter includes a flexible tubing having a proximal end and a distal end. The catheter also includes an electrode assembly attached to the distal end of the flexible tubing and having a first magnet therein. The electrode assembly further includes an electrically conductive tip electrode and an electrically nonconductive coupler which is connected between the tip electrode and the distal end of the flexible tubing. The coupler and the tip electrode are coupled by an interlocking connection. The catheter also includes a second magnet spaced from the electrode assembly along a longitudinal axis of the tubing. The first magnet and the second magnet are responsive to an external magnetic field to selectively position and guide the electrode assembly within a body of a patient.

Abstract: An elongate medical device handle may comprise a body defining an interior, an exterior, and a connector port extending between the interior and the exterior and defining an axis. The connector port comprises a portion having a polygonal cross-section taken transverse to the axis. In an embodiment, the polygonal cross-section may comprise a star shape. In an embodiment, a connector, such as a fluid connector, may be secured in the connector port using an adhesive.

Abstract: An apparatus for imparting a tensile force to deflect a distal portion of a catheter while maintaining its exterior dimensions may include a handle grip including a cross-section of generally predetermined exterior dimensions, and a longitudinal axis. A flexible elongate member may include proximal and distal end portions, with the proximal end portion being coupled to the handle grip. An adjustment knob may include a cross-section of generally predetermined exterior dimensions, and is rotatably coupled to the handle grip around the longitudinal axis. An elongate deflection member may be operably coupled to the adjustment knob and to the distal end portion of the elongate member. Rotation of the adjustment knob may impart a tensile force to the deflection member thereby causing the distal end portion of the elongate member to deflect from a prior configuration while maintaining the generally predetermined exterior dimensions of the handle grip and the adjustment knob.

Abstract: The present invention is an electrophysiology, RF ablation, or similar catheter (i.e., catheter or sheath) that includes an actuator that significantly increases the length of travel (i.e., steering travel) of the actuation wires, as compared to the length of travel provided by prior art actuators. The catheter includes a hollow flexible tubular body, a pair of actuation wires disposed in a side-by-side relationship in the body, a handle attached to a proximal end of the body, an actuator pivotally mounted to the handle, an arcuate internal gear rack disposed on the actuator, one or more pulleys pivotally mounted on the handle and coaxially coupled to a pinion gear engaged with the gear rack, and a guide block mounted within the handle. The one or more pulleys include a first channel in which the first actuation wire resides and a second channel in which the second actuation wire resides. The actuation wires pass through holes in the guide block, which aligns the wires into their respective channels.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis and comprising a distal end and a proximal end; and a plurality of lumens extending along the longitudinal axis of the elongated body, wherein at least one of the lumens is abutting at least another one of the lumens. A catheter comprising the deflectable catheter shaft section and a method of manufacturing the deflectable catheter shaft section are also disclosed. A catheter incorporating a deflectable catheter shaft section can further comprise first and second compression coils disposed over pull wires located within the catheter, wherein the compression coils are unattached to the catheter or components thereof, but can be constrained by a shaft coupler at a distal end of each of the compression coils and by at least a portion of a handle assembly at a proximal end of each of the compression coils.

Abstract: An electrophysiology catheter is provided. In one embodiment, the catheter includes an elongate, deformable shaft having a proximal end and a distal end and a basket electrode assembly coupled to the distal end of the shaft. The basket electrode assembly has a proximal end and a distal end and is configured to assume a compressed state and an expanded state. The electrode assembly further includes one or more tubular splines having a plurality of electrodes disposed thereon and a plurality of conductors. Each of the plurality of conductors extends through the tubular spline from a corresponding one of the plurality of electrodes to the proximal end of the basket electrode assembly. The tubular splines are configured to assume a non-planar (e.g., a twisted or helical) shape in the expanded state.

Abstract: A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Abstract: A transseptal medical device is provided including a dilator, a needle, and a needle control mechanism. The needle may be disposed within the dilator, and the needle control mechanism may be operably connected to a proximal end of the needle or the dilator for selective adjustment of the distal end of the needle from a first position within the dilator to a second position external to the dilator. The needle control mechanism may include an actuator configured for rotation within the dilator in one embodiment. In another embodiment, the proximal end of the dilator may incorporate internal threads and the proximal end of the needle may incorporate external threads, such that the needle may be configured for rotation during selective adjustment of the distal end of the needle from a first position to a second position. A method for puncturing a septum of a heart is also disclosed.

Abstract: An irrigated catheter with uniform cooling and/or uniform fluid distribution in longitudinally spaced apart elution holes by varying the diameter of a fluid delivery lumen. A number of elution holes are provided in a tip region of a catheter body, and these elution holes are in fluid communication with the lumen through ducts. The fluid delivery lumen may be provided with a flow constrictor to restrict flow of fluid towards the distal region.

Abstract: The present invention is directed to bipolar ablation systems. A bipolar electrode system for ablation therapy is disclosed, including a pressure-sensitive conducting composite layer and a pair of electrodes in electrical conductive contact or communication with the pressure-sensitive conducting composite layer. Energy (e.g., ablation energy) is delivered via the pressure-sensitive conductive composition when sufficient pressure is applied to transform the pressure-sensitive conductive composite to an electrical conductor. An electrically insulative flexible layer, which may include a passageway for a fill material is also disclosed. In some embodiments, the systems can also be used for targeted delivery of compounds, such as drugs, using a bipolar electrode.

Abstract: A dual braided catheter shaft includes an inner helical braid and outer helical braid than encapsulate an axially extending steering wire there between. In one embodiment, the shaft includes an inner polymer jacket, an inner braid formed on the inner jacket, a steering wire disposed along an outside surface of the inner braid, an outer braid formed over the inner braid and steering wire assembly and an outer jacket formed on the outer braid. The braiding parameters of the inner and outer braids can be varied along the length of the catheter to provide varying mechanical properties.

Abstract: A medical device is provided comprising a shaft comprising a first segment and a second segment. The first segment is configured to buckle upon application of a first critical force. The second segment includes an outer surface and an inner surface and is configured to buckle upon application of a second critical force. The second critical force is lower than the first critical force. The medical device further comprises a coil disposed radially inwardly of the inner surface of the second segment.

Abstract: A method for projecting a 3D surface geometry onto a planar projection comprises: obtaining a 3D geometry of a chamber surface using an algorithm that generates angles and distances between points on the chamber surface that represent mapping information; applying a cutting curve to at least two points on the chamber surface; and at least partially unfolding at least a portion of the chamber surface along the cutting curve to form a planar projection that optimally preserves the angles and distances between points on the chamber surface.

Abstract: The invention comprises self-lubricating polymer compositions that are especially useful in medical devices and valves and gaskets of medical devices. In a preferred embodiment, the polymer compositions comprise a thermosetting or thermoplastic silicone elastomer in combination with a lubricity enhancing polyfluoropolyether fluid or hydrocarbon-based synthetic oil. In other preferred embodiments, the polymer compositions contain only biocompatible components. The improved anti-friction properties of the self-lubricating polymers can be demonstrated over a course of insertion and withdrawal cycles, where conventional polymers have changing and mostly increasing force required for each insertion and withdrawal, while the polymer compositions of the invention remain stable.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis and comprising a distal end and a proximal end; and a plurality of lumens extending along the longitudinal axis of the elongated body, wherein at least one of the lumens is abutting at least another one of the lumens. A catheter comprising the deflectable catheter shaft section and a method of manufacturing the deflectable catheter shaft section are also disclosed. A catheter incorporating a deflectable catheter shaft section can further comprise first and second compression coils disposed over pull wires located within the catheter, wherein the compression coils are unattached to the catheter or components thereof, but can be constrained by a shaft coupler at a distal end of each of the compression coils and by at least a portion of a handle assembly at a proximal end of each of the compression coils.

Abstract: A monitoring, managing and protecting system is provided that includes a monitoring probe working in conjunction with an ablating device. The probe is configured to be positioned in close proximity to a region of non-targeted tissue proximate an ablation site of targeted tissue and to be operatively connected to an electrical response assessment system or component. The probe includes an elongate shaft having proximal and distal ends, with a handle disposed at the proximal end thereof and a tissue monitoring and protecting apparatus disposed at the distal end thereof. The ablating device includes an elongate shaft having proximal and distal ends, with a handle mounted at the proximal end thereof and an ablation element mounted at the distal end thereof. The monitoring probe measures electrical characteristics of the non-targeted tissue and/or of the tissue between the monitoring electrode and the ablation electrode.