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 shaft design facilitates allows for simultaneous stringing of wires and maintains a desired spacing and separation of the wires. In one implementation, a catheter shaft (504) and a core structure (500) are formed in separate manufacturing sequences. The core structure (500) includes a number of receptacles (506) formed in an external surface thereof and may further include a central lumen (508). Wires (501a,b, and 502a,b) are placed into the receptacles (506) and the core structure (500) with wires (501a,b and 502a,b) are inserted into the lumen of the catheter shaft (504). The wires (501a,b, and 502a,b,) can then be connected to electrodes or attached to a catheter tip so as to permit steering of the tip. The design can serve as a platform for various types of catheter.

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: Medical devices, methods of manufacturing medical devices, and systems comprising medical devices are provided. The device comprises a shaft having a major lumen sized to receive a second medical device and an electrode mounted thereon. The shaft includes an inner liner and outer layer. The method of manufacture includes forming a shaft by forming an inner liner and an outer layer by covering the inner liner with a polymeric material. The method further includes mounting an electrode onto the shaft of the device, and then heating and cooling the shaft. The system comprises a medical device having a shaft and an electrode mounted thereon. The shaft has a major lumen sized to receive another device. The system further comprises an electronic control unit configured to receive signals from the electrode and to determine a position of the electrode and/or monitor electrophysiological data.

Abstract: Medical devices and systems comprising medical devices are provided. The device comprises a shaft having a major lumen sized to receive a second medical device and an electroanatomical system imaging element mounted thereon. The shaft includes an inner liner and outer layer. The system comprises a medical device having a shaft and an electroanatomical system imaging element mounted thereon. The shaft has a major lumen sized to receive another device. The system further comprises an electroanatomical navigation system configured to receive signals from the electroanatomical system imaging element and to determine a position of the electroanatomical system imaging element and/or monitor electrophysiological data.

Abstract: A dual braided catheter shaft includes a flat wire forming the inner braid, thereby potentially allowing for reduced radial thickness of the shaft. In one embodiment, the shaft (100) includes an inner polymer jacket (104), an inner braid (106) formed on the inner jacket (104), an intermediate jacket (108) formed over the inner braid (106), an outer braid (110) formed on the intermediate jacket (108) and an outer jacket (112) formed on the outer braid (110). A preferred construction process involves extruding polymer material directly onto each of the inner and outer braids (106 and 110) so that little or no air gaps remain between the polymer material and the braids (106 and 110). The braiding parameters of the inner and outer braids (106 and 110) can be varied along the length of the catheter to provide varying mechanical properties.

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: Medical devices and systems comprising medical devices are provided. The kit includes a catheter-introducer comprising a shaft having a major lumen sized to receive a second medical device and an electrode mounted thereon and a catheter comprising an elongate body and at least two flexible electrode segments on the distal end. The shaft includes an inner liner and outer layer. The system comprises a first medical device having a shaft and an electroanatomical system imaging element mounted thereon and a second medical device having an elongate body and at least two flexible electrodes mounted on the distal end. The shaft has a major lumen sized to receive the second medical device. The system further comprises an electroanatomical navigation system configured to receive signals from the electroanatomical system imaging element and to determine a position of the electroanatomical system imaging element and/or monitor electrophysiological data.

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 assembly includes an inner liner made of flexible material and an outer layer having a steering mechanism. The steering mechanism includes at least one flat wire and a corresponding lumen through which the flat wire may travel. The steering mechanism may also include at least one pull ring to which the flat wires are attached. A layer of heat shrink material may encompass the outer layer. A braided wire assembly may also be provided in the outer layer, and may be formed by braiding a plurality of flat wires into a wire mesh. The overall cross-section of the catheter assembly is preferably substantially circular. A catheter shaft may include a plurality of segments of differing hardness characteristics. The outer layer typically comprises a melt processing polymer such that the catheter assembly may be laminated using heat.

Abstract: A kit for the diagnosis or treatment of tissue in a body cavity includes an introducer and a catheter insertable through the lumen of the introducer having a proximal segment, a working segment and a flexible distal tip segment. The flexible distal tip segment is located adjacent the distal end of the working segment and includes a proximal end, a distal end and a pre-formed bend or curve that permits the catheter to exit the introducer in a lateral direction relative to the introducer body to prevent inadvertent damage to the tissue during a medical procedure. All or part of the working segment and the flexible distal tip segment may be adhesive-filled. The catheter may also include a plurality of sensing and/or energy delivery elements on the working segment and a shape-memory wire terminating at the distal end of the working segment. Methods of use and methods of manufacturing are also described.

Abstract: An electrophysiology catheter includes an elongate catheter body having a distal end and a proximal end, a catheter tip including at least one metallic catheter component, such as an electrode, thereon, and at least one internal catheter component joined to the at least one metallic catheter component. The at least one internal catheter component includes a shape memory alloy and a metal compound that is capable of both bonding with the shape memory alloy and being metallurgically joined to the at least one metallic catheter component as by brazing. The metal compound may be a coating on or a core within the shape memory alloy. Suitable metal compounds include, without limitation, nickel, copper, brass, and combinations thereof.

Abstract: A circuit (10, 110, 210) configured for connecting an electrode (28, 126, 228) to a catheter or sheath is disclosed. The circuit (10, 110, 210) includes a member (12, 112, 212) having a longitudinal axis (14, 214) and configured to extend along at least a portion of the length of the catheter or sheath. The circuit (10, 110, 210) further includes a trace (16, 116, 230) printed on the member (12, 112, 212), where the trace (16, 116, 230) includes at least a longitudinal segment (18, 118) extending generally along at least a portion of the longitudinal axis (14, 214) and a transverse segment (20, 120) extending generally transverse to the longitudinal axis (14, 214). In an embodiment, the circuit further includes a pad (26, 126, 226) integral with and extending from the (10, 110, 210) proximal the transverse segment (20, 120) of the trace (16, 116, 230). A catheter or sheath assembly comprising the circuit (10, 110, 210) and an electrode (28, 126, 228) connected to the circuit (10, 110, 210) is also disclosed.

Abstract: The present invention relates to steerable access sheath assembly (12). Moreover, the present invention relates to a steerable short sheath access device (10) for use in epicardial procedures. Embodiments of the present invention including shorter steerable access sheaths or introducers (10, 12) may provide epicardial access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources. The steerable access device (10) provides an elongated member (20) having a proximal section (26) and a distal section (28), wherein the deflection of the distal section (28) provides a primary curve including an inner radius (r1) that result in a secondary curve of proximal section (26) having an inner radius (r2, r3), wherein the inner radius of curvature (r1) of the primary curve is less than the inside radius of curvature (r2, r3) of the secondary curve.

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: A method of manufacturing a catheter assembly generally includes providing a catheter shaft having an outer layer and an inner reinforcing layer; removing at least a portion of the outer layer from a length of the distal end of the catheter shaft in order to expose a distal segment thereof; providing an inner jacket segment; axially engaging the inner jacket segment with an interior surface of the distal segment of the catheter shaft; providing an outer jacket segment around at least the exposed exterior region of the distal segment of the catheter shaft; and bonding the distal segment of the catheter shaft to the inner jacket segment and the outer jacket segment.

Abstract: An electrophysiology catheter includes an elongate catheter body having a distal end and a proximal end, a catheter tip including at least one metallic catheter component, such as an electrode, thereon, and at least one internal catheter component joined to the at least one metallic catheter component. The at least one internal catheter component includes a shape memory alloy and a metal compound that is capable of both bonding with the shape memory alloy and being metallurgically joined to the at least one metallic catheter component as by brazing. The metal compound may be a coating on or a core within the shape memory alloy. Suitable metal compounds include, without limitation, nickel, copper, brass, and combinations thereof.

Abstract: A dual braided catheter shaft includes a flat wire forming the inner braid, thereby potentially allowing for reduced radial thickness of the shaft. In one embodiment, the shaft (100) includes an inner polymer jacket (104), an inner braid (106) formed on the inner jacket (104), an intermediate jacket (108) formed over the inner braid (106), an outer braid (110) formed on the intermediate jacket (108) and an outer jacket (112) formed on the outer braid (110). A preferred construction process involves extruding polymer material directly onto each of the inner and outer braids (106 and 110) so that little or no air gaps remain between the polymer material and the braids (106 and 110). The braiding parameters of the inner and outer braids (106 and 110) can be varied along the length of the catheter to provide varying mechanical properties.

Abstract: A catheter shaft design facilitates allows for simultaneous stringing of wires and maintains a desired spacing and separation of the wires. In one implementation, a catheter shaft (504) and a core structure (500) are formed in separate manufacturing sequences. The core structure (500) includes a number of receptacles (506) formed in an external surface thereof and may further include a central lumen (508). Wires (501a,b, and 502a,b) are placed into the receptacles (506) and the core structure (500) with wires (501a,b and 502a,b) are inserted into the lumen of the catheter shaft (504). The wires (501a,b, and 502a,b,) can then be connected to electrodes or attached to a catheter tip so as to permit steering of the tip. The design can serve as a platform for various types of catheter.