Abstract: This invention relates to a surgical device and method. More particularly, it relates to a tissue ablation device assembly and method using a circumferential ablation member in combination with a position monitoring assembly in order to position the circumferential ablation member along a circumferential region of tissue at a location where a pulmonary vein extends from a left atrium.

Abstract: A medical balloon catheter assembly includes a balloon having a permeable region and a non-permeable region. The balloon is constructed at least in part from a fluid permeable tube such that the permeable region is formed from a porous material which allows a volume of pressurized fluid to pass from within a chamber formed by the balloon and into the permeable region sufficiently such that the fluid may be ablatively coupled to tissue engaged by the permeable region. The non-permeable region is adapted to substantially block the pressurized fluid from passing from within the chamber and outwardly from the balloon. The porous material may be a porous fluoropolymer, such as porous polytetrafluoroethylene, and the pores may be created by voids which are inherently formed between an interlocking node-fibril network which makes up the fluoropolymer. Such voids may be created according to one mode by expanding the fluoropolymer.

Abstract: A medical balloon catheter assembly includes a balloon having a permeable region and a non-permeable region. The balloon is constructed at least in part from a fluid permeable tube such that the permeable region is formed from a porous material which allows a volume of pressurized fluid to pass from within a chamber formed by the balloon and into the permeable region sufficiently such that the fluid may be ablatively coupled to tissue engaged by the permeable region. The non-permeable region is adapted to substantially block the pressurized fluid from passing from within the chamber and outwardly from the balloon. The porous material may be a porous fluoropolymer, such as porous polytetrafluoroethylene, and the pores may be created by voids that are inherently formed between an interlocking node-fibril network that makes up the fluoropolymer. Such voids may be created according to one mode by expanding the fluoropolymer.

Abstract: Disclosed is a method for attaching a sensor to an inflatable balloon. The method involves bonding the sensor to the balloon with an adhesive while the balloon is in an expanded state and then collapsing the balloon after the adhesive has at least partially cured. The method reduces the possibility of a failure of the bond between the sensor and the balloon. The method is particularly useful in the construction of a tissue ablation catheter for forming a lesion along a substantially circumferential region of tissue wherein a sensor is used for monitoring the temperature of the tissue being ablated.

Abstract: An improved system and method for ablating a tissue site is provided. In one embodiment, the system comprises an ablation catheter employing one or more electrodes and multiple temperature sensors located along the catheter distal end. The temperature sensors control the power applied to the one or more electrodes. A deflection mechanism may be included to provide directional control to the catheter.

Abstract: A medical device assembly and method provides an ultrasound transducer mounted onto a catheter shaft. The ultrasound transducer is mounted such that there is a radial separation between the transducer and the underlying catheter shaft. The transducer is mounted on support structures which do not bridge the gap between the transducer and delivery member. The location of the support structures provides for an “airbacked” transducer that is very efficient and prevents heat build-up in the materials in contact therewith.

Abstract: This invention is a circumferential ablation device assembly which is adapted to form a circumferential conduction block in a pulmonary vein. The assembly generally comprises a handheld surgical ablation probe having a rigid shaft for insertion through a patient's chest and a circumferential ablation element mounted on the distal end portion of the shaft. The circumferential ablation element is adapted to ablate a circumferential region of tissue along a pulmonary vein wall which circumscribes the pulmonary vein lumen. The circumferential ablation element includes an expandable member for anchoring the distal end portion of the shaft in a body structure and an ultrasound transducer disposed within the expandable member for emitting ultrasonic energy to ablate the tissue in the pulmonary vein.

Abstract: A dual curve ablation catheter (2), especially suited for treating atrial flutter, includes a shaft (4) with a deflectable tip (20) at the distal end (6) and a handle (10) at the proximal end (8). The tip includes a highly flexible distal segment (30), a relatively stiff intermediate segment (28) and a flexible proximal segment (26) so that pulling on a manipulator wire (16) attached to the distal segment causes the distal segment to curve and engage, for example, an isthmus of tissue (106) adjacent the tricuspid valve (104) and the inferior vena cava (98) and causes the proximal segment to curve and press against the wall (110) of the inferior vena cava so to stabilize the catheter. Ablation energy can be supplied through the ablation electrodes (48, 68) simultaneously or one at a time to ablate tissue at the isthmus without the need for moving the catheter.

Abstract: A steerable electrophysiology catheter includes a shaft having a distal ablation segment with one or more electrodes coupled to a source of electrical energy by a connector extending through the shaft. The distal ablation segment of the shaft is movable between a collapsed configuration sized for percutaneous introduction into the patient and/or endoluminal delivery to the target site and an expanded configuration, in which the distal ablation segment forms a substantially continuous surface transverse to the shaft axis for engaging the heart tissue and creating a linear lesion thereon. The catheter includes one or more force element(s) positioned to apply an axial force between the distal and proximal ends of the ablation segment. The force element(s) provide a sufficiently uniform force against the distal ablation segment to establish continuous contact pressure between the electrodes and the patient's heart tissue.

Abstract: A catheter ablation system including a catheter having a distal segment carrying at least one electrode extending along the segment and having a number of temperature sensors arranged along the distal segment adjacent the electrode, each providing an output indicative of temperature. The catheter is coupled to a power source which provides R-F energy to the electrode and with temperature processing circuitry coupled to the temperature sensors and the power source which controls power output from the power source as a function of the outputs of the temperature sensors. In a preferred embodiment, the temperature processing circuitry includes circuitry for comparing the temperature indicated by the temperature sensors to a known reference sensor and circuitry for disabling subsequent use of an output of one of the sensors if the output from the sensor differs from the referenced temperature by more than a defined value.

Abstract: An electrode array catheter, typically used for mapping, pacing and ablation, includes a flexible delivery sheath (36, 64) and an electrode assembly (2, 62) slidably mounted within the delivery sheath for movement between retracted and deployed positions. The electrode assembly includes an ablation electrode (10, 90) and a plurality of mapping electrodes (26, 114) which are grouped in pairs and naturally assume a three-dimensional array when deployed. The electrodes are distributed to contact a portion of the chamber wall (130) surrounding the target site. The electrode assembly tip has a coiled conical shape (24) in one embodiment and has a number of axially extending, radially outwardly curved arms (118) in another embodiment. A flat flexible circuit (110), having axially extending electrode traces (112) connecting proximal terminals (108) to distal electrode pads (114), is slit (116) axially and is preformed and to create the curved arms.

Abstract: A linear ablation catheter assembly (2) includes a handle (4) from which a hollow outer shaft (8) extends. A hollow inner catheter (10) is slidably housed within the outer shaft. The handle has a manipulator (18) which moves the inner catheter along the interior of the outer shaft. The inner catheter has an opening (22) alignable with and movable along a longitudinally-extending opening (14) formed in the hollow outer shaft. A typically perforated, electrode is mounted to the inner catheter (10, 17; 10a, 17a) or the outer shaft (10b, 17b) is spaced-apart from the outer surface (30) of the outer shaft. The handle is coupled to a source (28) of energy-conducting liquid (29) which flows through the inner catheter, out the inner catheter opening, past the perforated electrode, between fluid seals (32, 32c) secured to the inner shaft and through the longitudinally-extending opening to ablate tissue.

Abstract: A dual curve ablation catheter (2), especially suited for treating atrial flutter, includes a shaft (4) with a deflectable tip (20) at the distal end (6) and a handle (10) at the proximal end (8). The tip includes a highly flexible distal segment (30), a relatively stiff intermediate segment (28) and a flexible proximal segment (26) so that pulling on a manipulator wire (16) attached to the distal segment causes the distal segment to curve and engage, for example, an isthmus of tissue (106) adjacent the tricuspid valve (104) and the inferior vena cava (98) and causes the proximal segment to curve and press against the wall (110) of the inferior vena cava so to stabilize the catheter. Ablation energy can be supplied through the ablation electrodes (48, 68) simultaneously or one at a time to ablate tissue at the isthmus without the need for moving the catheter.

Abstract: A steerable electrophysiology catheter includes a shaft having a distal ablation segment with one or more electrodes coupled to a source of electrical energy by a connector extending through the shaft. The distal ablation segment of the shaft is movable between a collapsed configuration sized for percutaneous introduction into the patient and/or endoluminal delivery to the target site and an expanded configuration, in which the distal ablation segment forms a substantially continuous surface transverse to the shaft axis for engaging the heart tissue and creating a linear lesion thereon. The catheter includes one or more force element(s) positioned to apply an axial force between the distal and proximal ends of the ablation segment. The force element(s) provide a sufficiently uniform force against the distal ablation segment to establish continuous contact pressure between the electrodes and the patient's heart tissue.

Abstract: A catheter assembly (2) includes a catheter shaft (6) having a tip portion (10) with a hollow interior (30) and a linear ablation electrode (18, 34, 36, 44, 58) spaced apart from the distal end (22) of the tip portion. The electrode has an inner surface (28) which is effectively fluidly exposed to the hollow interior so that a cooling fluid (32) passing through the interior contacts the inner surface so to effectively cool the electrode. The electrode can include a series of band electrodes (18, 34) or one or more spiral electrodes (36, 44, 58). One method for making the tip portion involves mounting the electrode to a mandrel, filling the spaces between the edges (26) of the electrode with a polymer and then removing the resulting tubular structure from the mandrel. The cooling fluid can pass through a hollow spiral electrode (58) for enhanced cooling effectiveness.

Abstract: A catheter assembly (2) includes a proximal end assembly (4), with four slidable movable manipulators (12, 14, 16, 18) and a bowing catheter (6) extending from the proximal end assembly. The bowing catheter includes an elongate, flexible catheter body (24), having a tip portion (30) carrying electrodes (32), first and second elongate push/pull manipulator wires (26, 28), and a sheath (22) housing the catheter body and manipulator wires. The sheath, catheter body and manipulator wires are each coupled to a manipulator. The manipulator wires are connected to positions (40, 42) on either side of a stiff tip segment (43). The manipulator wires have sufficient columnar strength/stiffness to maintain the tip segment at a range of relatively stable orientations to cause the bowed tip to be deflected in in-plane and out-of-plane deflections.

Abstract: A deflectable ablation catheter which includes an elongated catheter body with an electrode located along a distal section of the catheter body. The catheter is provided with a deflection wire coupled to the distal end of the catheter body which on longitudinal movement causes deflection of the distal section of the catheter body into a planar curve, and a core wire coupled to a point proximal to the distal section of the catheter body and coupled to the catheter body so that upon application of torque to the wire, the planar curve formed along the distal section is rotated into a second plane. A handle is provided at the proximal end of the catheter and carries controls coupled to the core wire and the deflection wire.

Abstract: A vascular catheter for delivering a uniform flow of therapeutic fluid over a length of the catheter. The catheter is particularly suitable for delivering thrombolytic agents to a thrombus or clot in a patient's arterial system. In a preferred embodiment, the catheter has a relatively thick-walled tubular body with a central lumen for advancement over a guidewire and a plurality of fluid delivering lumens disposed within the relatively thick wall. Each of the smaller lumens has a single flow passageway to discharge therapeutic fluid to the exterior of the catheter.

Abstract: A vascular catheter for delivering a uniform flow of therapeutic fluid over a length of the catheter. The catheter is particularly suitable for delivering thrombolytic agents to a thrombus or clot in a patient's arterial system. In a preferred embodiment, the catheter has a relatively thick-walled tubular body with a central lumen for advancement over a guidewire and a plurality of fluid delivering lumens disposed within the relatively thick wall. Each of the smaller lumens has a single flow passageway to discharge therapeutic fluid to the exterior of the catheter.

Abstract: Dual lumen dilatation catheter and method of manufacture in which the catheter shaft is formed in a plurality of sections of different stiffness to provide optimum strength and flexibility at different points along the length of the catheter.