Abstract: A deflectable medical device incorporates a strut that is configured to reduce or eliminate axial shortening of the deflectable portion of the medical device, for example, the deflectable distal end portion of a catheter or access sheath. The strut may is coaxially disposed in the medical device in the section that is contemplated to undergo the repeated deflection. The strut provides improved column strength and axial restoration. The strut may be stent-like device, an elongate device having opposing ends coupled by a connecting lattice involving a plurality of helical connecting elements or a tube having a plurality of circumferentially-extending slots arranged in longitudinally-extending rows.

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 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 catheter with a mechanism for omni-directional deflection of a catheter shaft includes a shaft assembly and a controller. The shaft assembly includes a first tubular component that has a preformed curvilinear distal section, a second, substantially straight tubular component with a main axis and an outer shaft. The first and second components are configured for slidable movement therebetween while preserving common rotation so that when the second component is axially moved in a distal direction, the second component deflects the preformed curvilinear section towards the main axis while orientation of the outer shaft is preserved. The controller is configured to effect relative axial movement between the first and second components as well as to effect rotation of the first and second components (and thus also of the preformed curvilinear distal section) without any rotation of the shaft relative to the handle.

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: A catheter with a mechanism for omni-directional deflection of a catheter shaft includes a shaft assembly and a controller. The shaft assembly includes a first tubular component that has a preformed curvilinear distal section, a second, substantially straight tubular component with a main axis and an outer shaft. The first and second components are configured for slidable movement therebetween while preserving common rotation so that when the second component is axially moved in a distal direction, the second component deflects the preformed curvilinear section towards the main axis while orientation of the outer shaft is preserved. The controller is configured to effect relative axial movement between the first and second components as well as to effect rotation of the first and second components (and thus also of the preformed curvilinear distal section) without any rotation of the shaft relative to the handle.

Abstract: The present invention provides various embodiments of electrodes and/or electrode tips for use in connection with ablation catheters and ablation catheter systems. In an embodiment, an electrode tip for an ablation catheter is provided, comprising an electrode carrier, a first electrode, and second electrode, each adapted to direct energy is various directions and configured to be selectively activated. In another embodiment, an electrode is provided that comprises an electrode body having an insulated portion to protect adjacent tissue from ablation while further adapted to direct energy in a downward direction towards the target tissue. Other embodiments of electrodes and/or electrode tips providing ablative elements that are directed laterally are also disclosed. Moreover, embodiments of several types of electrodes and/or electrode tips, which may include positioning, orientation, irrigating, cooling, and deflecting features, whether provided individually or in various combinations, are also disclosed.

Abstract: An elongate medical device shaft may comprise an elongate body and an annular electrode disposed on the elongate body. The annular electrode may define a longitudinal axis and have an outer diameter. The outer diameter may be greater at an axial center of the electrode than at an axial end of the electrode. Additionally or alternatively, the elongate body may comprise three longitudinal sections having three wall thicknesses. The middle wall thickness may be less than the proximal and distal wall thicknesses and the distal wall thickness may be less than the proximal wall thickness. Additionally or alternatively, the shaft may comprise an inner cylindrical structure and an outer tube. The outer tube may comprise a first radial layer and a second radial layer that is radially-outward of the first radial layer, the first radial layer, second radial layer, and inner structure having different stiffnesses.

Abstract: Catheter systems and methods are disclosed. An exemplary catheter includes an outer tubing housing and an inner fluid delivery tubing, the inner fluid delivery tubing having at least one fluid delivery port. The catheter also includes a deployment member movable axially within the inner fluid delivery tubing. A plurality of splines are each connected at a proximal end to the outer tubing and at a distal end to deployment member. A seal is provided between the outer tubing and the inner fluid delivery tubing. A gasket is provided between the deployment member and the inner fluid delivery tubing. Both the seal and the gasket are configured to prevent blood or other fluid from ingressing into the outer tubing.

Abstract: A deflectable medical device incorporates a strut that is configured to reduce or eliminate axial shortening of the deflectable portion of the medical device, for example, the deflectable distal end portion of a catheter or access sheath. The strut may is coaxially disposed in the medical device in the section that is contemplated to undergo the repeated deflection. The strut provides improved column strength and axial restoration. The strut may be stent-like device, an elongate device having opposing ends coupled by a connecting lattice involving a plurality of helical connecting elements or a tube having a plurality of circumferentially-extending slots arranged in longitudinally-extending rows.

Abstract: A catheter is disclosed having a flexible tubing with a proximal end and a distal end. The catheter comprising at least one movable magnet provided within the distal end of the flexible tubing. A control mechanism is operable to selectively activate the at least one movable magnet from the proximal end of the flexible tubing. The at least one movable magnet is responsive to an external magnetic field to position and guide the distal end of the flexible tubing within a body of a patient.

Abstract: Method and devices for delivering pulsed RF ablation energy to enable the creation of lesions in tissue are disclosed. The delivery of RF energy is controlled such that the generator power setting remains sufficiently high to form adequate lesions while mitigating against overheating of tissue. An ablation catheter tip having high-thermal-sensitivity comprises a thermally-insulative ablation tip insert supporting at least one temperature sensor and encapsulated, or essentially encapsulated, by a conductive shell. A system for delivering pulsed RF energy to a catheter during catheter ablation comprises an RF generator and a pulse control box operatively connected to the generator and configured to control delivery of pulsatile RF energy to an ablation catheter comprising at least one temperature sensor mounted in its tip. Also disclose is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using pulsatile delivery of RF energy.

Abstract: Method and devices for delivering pulsed RF ablation energy to enable the creation of lesions in tissue are disclosed. The delivery of RF energy is controlled such that the generator power setting remains sufficiently high to form adequate lesions while mitigating against overheating of tissue. An ablation catheter tip having high-thermal-sensitivity comprises a thermally-insulative ablation tip insert supporting at least one temperature sensor and encapsulated, or essentially encapsulated, by a conductive shell. A system for delivering pulsed RF energy to a catheter during catheter ablation comprises an RF generator and a pulse control box operatively connected to the generator and configured to control delivery of pulsatile RF energy to an ablation catheter comprising at least one temperature sensor mounted in its tip. Also disclose is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using pulsatile delivery of RF energy.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: Medical devices for diagnosis or treatment of tissue in a body. Representative devices include an elongate shaft having a proximal portion and a distal portion configured for movement relative to the proximal portion. A flexible member having a predetermined stiffness is disposed between the proximal and distal portions. One or more coils and an electrically passive element are disposed within the shaft with either the coils or element configured for movement with the distal portion. The element comprises a material effecting an electrical characteristic of the coils. Movement of the distal portion in response to its contact with the tissue and relative movement of the coils and element causes a change in the electrical characteristic in at least one of the coils indicative of at least a contact force magnitude between the distal portion and the tissue. Several embodiments allow determination of both force magnitude and force vector direction.

Abstract: The present invention relates to steerable access sheath assembly including at least one electrode. Moreover, the present invention relates to a steerable sheath access device for use in cardiovascular procedures. Embodiments of the present invention including steerable access sheaths or introducers may provide cardiovascular access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources.

Abstract: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter or more proximally located. Tip electrodes can be constructed from an electrically-insulative substrate covered with a conductive material. The conductive material can be deposited on the electrically-insulative substrate to form a single tip electrode or multiple segmented electrodes. In some embodiments the tip electrode can include irrigation flow holes for irrigation. A method of manufacturing a tip electrode comprising a thin layer of conductive material deposited on an electrically-insulative substrate is disclosed. Segmented ring electrodes can be constructed from segmented ring electrodes that can be equally separated around a circumference of a catheter. The segmented ring electrodes can be formed into segmented electrode subassemblies that can then be joined to a catheter shaft.

Abstract: The instant disclosure relates generally to a tip electrode for delivering irrigant to a distal portion of the tip electrode and irrigated catheter tips incorporating such a tip electrode. The distal portion of the tip electrode can have additional fluid ports on the distal edge of the tip to provide additional fluid flow to that region.

Abstract: Catheter actuators providing a mechanical advantage are disclosed. The actuators include a pull wire arm guide plate and a drive wheel attached around the pull wire arm guide plate and pivotable relative to the guide plate, the drive wheel comprising at least one thumb boss for pivoting the drive wheel about a drive wheel axis of rotation. The drive wheel mechanically engages at least one pull wire arm slidably mounted in a pull wire arm channel in the pull wire arm guide plate. A mechanism transfers drive wheel input into longitudinal motion of the at least one pull wire arm. The mechanism may include, for example, a pin pushing against a bendable pushing member riding in an arcuate pin groove in a top surface of the guide plate, or a pin pushing against a surface of a cam arm pivotably mounted on the top surface of the guide plate.