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: An electrophysiology catheter for use with a steerable introducer sheath includes a flexible catheter body having a proximal end and a distal end and at least one hollow elongate tip electrode disposed at the distal end of the catheter body. The hollow elongate tip electrode includes a sidewall having at least one elongate gap that provides flexibility allowing the tip electrode to bend relative to a longitudinal axis of the catheter body. The catheter body is an independent, non-steerable structure, and can be moved via movement of the steerable introducer through which it is introduced into a patient.

Abstract: Catheter ultrasound systems including a sheath, a handle, a sheath lumen, and an ultrasound catheter disposed within the lumen of the sheath with ultrasound elements capable of visualizing anatomical regions. The handle allowing the ultrasound catheter to rotate with respect to the sheath using a rotation adjustment knob within the handle or alternatively an separate manipulation handle attached to the proximal end of the ultrasound catheter. The sheath, ultrasound catheter, or both may also include one or more electrodes or other location sensor for both orienting the ultrasound element as well as for diagnostic purposes.

Abstract: An exemplary basket catheter includes an outer tubing housing an inner fluid delivery tubing having at least one fluid delivery port. A plurality of splines are each connected at a proximal end of the splines to the outer tubing and at a distal end of the splines to the inner fluid delivery tubing. The inner fluid delivery tubing is operable to be moved in a first direction to expand the splines; and in a second direction to collapse the splines. A porous membrane is provided over at least a portion of the inner fluid delivery tubing. A seat is provided at a proximal end of the porous membrane between the porous membrane and the outer tubing and between the porous membrane and the inner fluid delivery tubing, the seal configured for irrigating between the plurality of splines of the basket catheter while preventing fluid ingress into the outer tubing.

Abstract: An exemplary basket catheter includes an outer tubing housing an inner fluid delivery tubing having at least one fluid delivery port. A plurality of splines are each connected at a proximal end of the splines to the outer tubing and at a distal end of the splines to the inner fluid delivery tubing. The inner fluid delivery tubing is operable to be moved in a first direction to expand the splines; and in a second direction to collapse the splines. A porous membrane is provided over at least a portion of the inner fluid delivery tubing. A seal is provided at a proximal end of the porous membrane between the porous membrane and the outer tubing and between the porous membrane and the inner fluid delivery tubing, the seal configured for irrigating between the plurality of splines of the basket catheter while preventing fluid ingress 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 method is provided for ablating a portion of the myocardium. The method includes inserting an occlusion catheter into a vessel on a heart, occluding the vessel using the occlusion catheter, inserting an ablation catheter into a chamber of the heart, positioning the ablation catheter against the myocardium, and ablating a portion of the myocardium while the vessel is occluded. The system includes an occlusion catheter having a catheter body including a tubular member having a distal portion and a bend located in the distal portion, a balloon located proximal of the bend and configured to contact an inner surface of the CS when positioned therewithin, a plurality of marker bands positioned on the catheter body, and a plurality of electrodes positioned on the catheter body. One or more electrodes or coils can be used as a reference for an electroanatomical system and can be disposed on the occlusion catheter.

Abstract: A method is provided for ablating a portion of the myocardium. The method includes inserting an occlusion catheter into a vessel on a heart, occluding the vessel using the occlusion catheter, inserting an ablation catheter into a chamber of the heart, positioning the ablation catheter against the myocardium, and ablating a portion of the myocardium while the vessel is occluded. The system includes an occlusion catheter having a catheter body including a tubular member having a distal portion and a bend located in the distal portion, a balloon located proximal of the bend and configured to contact an inner surface of the coronary sinus when positioned therewithin, a plurality of marker bands positioned on the catheter body, and a plurality of electrodes positioned on the catheter body.

Abstract: Catheter systems and methods are disclosed for anchoring the catheter system to tissue, e.g., for delivery of biologic or chemical agents, or other therapeutic fluid during various procedures. An exemplary tissue anchoring catheter comprises an outer catheter shaft connected to a catheter handle. A delivery sheath is provided within the outer catheter shaft, the delivery sheath housing a needle. At least one anchor is operatively associated with the delivery sheath, the at least one anchor operable at the catheter handle to secure the delivery sheath to tissue for conveying biologic or chemical agents, or other therapeutic fluid from the needle to the tissue. The tissue anchoring catheter may further comprise sensing means such as piezoelectric, pressure, thermistor, thermocouple, or ultrasound sensors.

Abstract: A catheter for anchoring an electrode in a coronary sinus includes an elongate catheter body adapted to be inserted into a coronary sinus and at least one electrode on the catheter body. The elongate catheter body also includes at least one anchor movable between an undeployed configuration and a deployed configuration. When the anchor is in the undeployed configuration, the catheter may be introduced into and removed from the coronary sinus. When the anchor is in the deployed configuration, the anchor engages a tissue surface of the coronary sinus to inhibit movement between the catheter body and the coronary sinus, preferably without completely occluding the coronary sinus. The anchor may be a section of the catheter body having an expandable axial cross-section, an expandable member mounted on the catheter body, one or more wire anchors, or a flexible section of the catheter body.

Abstract: A method of manufacturing a catheter shaft includes extruding an inner polymeric layer having a main lumen and two or more side lumens spaced about the main lumen; forming an outer polymeric layer about the inner polymeric layer; and inserting at least one elongate member, such as a wire, through each side lumen of the inner polymeric layer. The side lumens are less than about ? the size of the main lumen. The method may further include the step of forming a braided layer between the inner polymeric layer and the outer polymeric layer. In an alternate embodiment, the method includes co-extruding an inner polymeric layer and a multi-lumen layer, the multi-lumen layer having two or more side lumens; forming an outer polymeric layer about the multi-lumen layer; and inserting at least one elongate member through each side lumen. Catheter assemblies made according to the described methods are also disclosed.

Abstract: Catheter systems and methods are disclosed including a seal for helping direct an anticoagulant or other fluid for proper irrigation in a basket catheter. An exemplary basket catheter includes an outer tubing housing an inner fluid delivery tubing having at least one fluid delivery port. A plurality of splines each connected at a proximal end of the splines to the outer tubing and at a distal end of the splines to the inner fluid delivery tubing. The inner fluid delivery tubing is operable to be moved in a first direction relative to the outer tubing to expand the splines to a deployed position. The inner fluid delivery tubing is also operable to be moved in a second direction relative to the outer tubing to collapse the splines to an undeployed position. A porous membrane is provided over at least a portion of the inner fluid delivery tubing having the at least one fluid delivery port.

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: Catheter systems and methods are disclosed for anchoring the catheter system to tissue, e.g., for delivery of biologic or chemical agents, or other therapeutic fluid during various procedures. An exemplary tissue anchoring catheter comprises an outer catheter shaft connected to a catheter handle. A delivery sheath is provided within the outer catheter shaft, the delivery sheath housing a needle. At least one anchor is operatively associated with the delivery sheath, the at least one anchor operable at the catheter handle to secure the delivery sheath to tissue for conveying biologic or chemical agents, or other therapeutic fluid from the needle to the tissue. The tissue anchoring catheter may further comprise sensing means such as piezoelectric, pressure, thermistor, thermocouple, or ultrasound sensors.

Abstract: A sealing device for sealing punctures in blood vessel walls including a flange connected to a flexible stem having an expansion portion in it. The flexible stem is adapted to be accommodated inside a delivery tube. The delivery tube further includes a hand-hold for ease of handling. The sealing device may further include a loader and a cutter. The flange and flexible stem are preferably constructed of a biodegradable material that has a tensile strength, rigidity, memory and other physical qualities similar to medical grade silicone. The resilient transverse expansion portion expands when deployed beyond the delivery tube in the tissue tract to create a frictional interface with the interior surface of the tissue tract to resist displacement of the flexible stem from a desired location in the tissue tract. The flexible stem also includes a flange at the distal end of the flexible stem to seal the puncture when the flexible stem is deployed.

Abstract: A device and system for delivery of a flowable biocompatible material to a tissue tract in a controlled manner generally includes a reservoir adapted to be in fluid connection with a cannula, a discharging mechanism adapted to discharge the contents of the reservoir and a cannula retractor to withdraw the cannula. The cannula retractor is operably interconnected with the discharging mechanism so that a measured quantity of the reservoir contents is smoothly discharged to substantially fill at least a portion of the tissue tract.

Abstract: A sealing device for sealing punctures in blood vessel walls including a flange connected to a flexible stem having an expansion portion in it. The flexible stem is adapted to be accommodated inside a delivery tube. The delivery tube further includes a hand-hold for ease of handling. The sealing device may further include a loader and a cutter. The flange and flexible stem are preferably constructed of a biodegradable material that has a tensile strength, rigidity, memory and other physical qualities similar to medical grade silicone. The resilient transverse expansion portion expands when deployed beyond the delivery tube in the tissue tract to create a frictional interface with the interior surface of the tissue tract to resist displacement of the flexible stem from a desired location in the tissue tract. The flexible stem also includes a flange at the distal end of the flexible stem to seal the puncture when the flexible stem is deployed.

Abstract: Safe and convenient methods and devices for inexpensively and rapidly treating pseudoaneurysms and other subcutaneous pools of blood utilize an apparatus with an applicator that can be grasped by a user at its proximal end and which has a distal portion that can be percutaneously inserted into a pseudoaneurysm. The distal portion has at least one retaining structure on at least one surface; the retaining structure(s) serve to collectively retain a clotting agent as the distal portion is inserted into the pseudoaneurysm. The clotting agent in the retaining structure(s) is exposed to blood in the pseudoaneurysm and initiates a clotting cascade. Since the clotting agent is in the retaining structure(s) and is not forcibly injected into the blood, the clotting cascade causes blood to clot at or near the surface of the applicator. The clot is associated with the applicator until the distal portion of the applicator is removed from the pseudoaneurysm.