Abstract: The subject of this disclosure includes systems, devices and methods to treat a predetermined patient population for paroxysmal atrial fibrillation, the method including ablating tissue of one or more targeted pulmonary veins with one or more of a plurality of the electrodes of an independently controlled multi-electrode radiofrequency balloon catheter, the balloon catheter comprising the plurality of electrodes for radiofrequency ablation that are independently controllable; determining a predictor, based on ablation parameters of the balloon catheter, of single shot pulmonary vein isolation (PVI) success rate; and achieving, based on the predictor and step of ablating tissue, a single shot isolation PVI success rate in the isolation of all targeted pulmonary veins for the predetermined patient population.

Abstract: A catheter is made by coextruding first and second molten polymers, wherein the second molten polymer forms a flexible inner core and the first molten polymer forms exactly two bands on opposite sides of the inner core. The inner core is braided, and a third molten polymer extruded onto the braid to form a flexible jacket that encloses the braid, the bands and the inner core. The bands are more rigid than the inner core, and they provide preferential in-plane bending.

Abstract: A medical instrument includes an expandable balloon, an intra-balloon deflection assembly, and one or more puller wires. The expandable balloon is coupled to a distal end of a shaft for insertion into a body of a patient. The intra-balloon deflection assembly is also coupled to the distal end of the shaft, and includes a distal section of the shaft which extends partially through the expandable balloon and includes (i) an elastic element coupled to a proximal side of the expandable balloon and configured to be bent relative to a longitudinal axis of the shaft, and (ii) a rigid element coupled to a distal side of the expandable balloon. The one or more puller wires are coupled to the rigid element and are configured to bend the elastic element, thereby deflecting the expandable balloon.

Abstract: Described embodiments include an apparatus that includes an intrabody probe and an electrode coupled to a distal end of the intrabody probe. The electrode includes a flexible electrically-insulating substrate, comprising a substrate surface. The electrode further includes a layer of an electrically-conducting metal covering at least part of the substrate surface. The electrode further includes a metallic sheet, comprising an inner sheet surface, and an outer sheet surface shaped to define multiple depressions. The electrode further includes an adhesive, which fills the depressions and bonds the outer sheet surface to the layer of the electrically-conducting metal. Other embodiments are also described.

Abstract: The subject of this disclosure is devices, systems, and uses thereof to treat a plurality of patients for paroxysmal atrial fibrillation. The solution can include delivering a multi-electrode radiofrequency balloon catheter and a multi-electrode diagnostic catheter to one or more targeted pulmonary veins; ablating tissue of the one or more targeted pulmonary veins using the multi-electrode radiofrequency balloon catheter; diagnosing the one or more targeted pulmonary veins using the multi-electrode diagnostic catheter; and achieving at least one of a predetermined clinical effectiveness and acute effectiveness of the method or use based on use of the multi-electrode radiofrequency balloon catheter and the multi-electrode diagnostic catheter in the isolation of the one or more targeted pulmonary veins.

Abstract: A catheter manufacturing method includes the step of providing a hollow cylindrical part of a catheter, having a longitudinal axis, to be bonded to a given part along respective edge surfaces of the hollow cylindrical and the given parts. One or more undercut structures that are disposed circumferentially with respect to the longitudinal axis and also generally parallel to the longitudinal axis, the undercut structures having a radial orientation with respect to the longitudinal axis, are formed at least in the edge surface of the hollow cylindrical part. The hollow cylindrical part and the given part are connected using the undercut structures.

Abstract: A balloon catheter includes a shaft, a balloon made of an expandable membrane, a flexible substrate, one or more electrodes, and one or more radiopaque flags. The shaft is configured for insertion into a heart of a patient. The balloon is fitted at a distal end of the shaft. The flexible substrate is disposed on the membrane. The one or more electrodes are disposed over the flexible substrate and have a fishbone configuration. The one or more radiopaque flags are coupled to the expandable membrane, wherein the one or more radiopaque flags include a serpentine pattern so that the radiopaque flags fold in conformance with flexible substrate as the expandable membrane is collapsed into a compressed or folded configuration.

Abstract: Described embodiments include an apparatus that includes a flexible electrically-insulating substrate, including an inner surface and an outer surface, and shaped to define (i) multiple narrower channels passing between the inner surface and the outer surface, and (ii) one or more wider channels passing between the inner surface and the outer surface. The apparatus further includes an outer layer of an electrically-conducting metal covering at least part of the outer surface, an inner layer of the electrically-conducting metal covering at least part of the inner surface, a plating layer of the electrically-conducting metal that plates the wider channels such as to connect the outer layer to the inner layer, and respective columns of the electrically-conducting metal that fill the narrower channels such as to connect the outer layer to the inner layer. Other embodiments are also described.

Abstract: Described embodiments include a catheter tip that includes an outer layer of a thermally-conducting metal; an inner layer of a thermally-conducting metal; a polymer layer between the inner and outer layer; and a plurality of thermal bridges selectively positioned between the inner and outer layers and through the polymer layer thereby significantly increasing the heat transfer of the catheter tip through the polymer layer. Other embodiments are also described.

Abstract: A method, consisting of providing a metal wire having a wire diameter and an end, and positioning a conductor at a distance from the end of the wire. The method further includes creating an electrical discharge between the conductor and the end, while setting the distance and an electrical potential of the discharge, so as to create a bead of a predefined size on the end. The method also includes assembling the wire with the created bead into an invasive probe, so that the bead is positioned at an outer surface of the probe.

Abstract: A medical instrument includes a shaft, multiple flexible spines and multiple electrodes. The shaft is configured for insertion into a body of a patient. The multiple flexible spines have respective first ends that are connected to a distal end of the shaft and respective second ends that are free-standing and unanchored. The spines are bent proximally such that the second ends are more proximal than the first ends. Each of the flexible spines includes a tensile layer configured to cause the flexible spine to bend proximally. The multiple electrodes are disposed over the flexible spines.

Abstract: A method for tissue assessment includes ablating tissue at a site within a body of a living subject using an invasive probe applied to the site. At a first stage in ablation of the tissue, first measurements are made of scattered light intensities from the site at a plurality of different wavelengths. At a second stage in the ablation of the tissue, subsequent to the first stage, second measurements are made of the scattered light intensities from the site at the plurality of different wavelengths. Progress of the ablation is assessed by computing different, respective measures of change in the scattered light intensities at the different wavelengths occurring between the first and second measurements, and comparing the respective measures.

Abstract: A catheter adapted to slidably receive a hollow shaft through its lumen. An expandable balloon is attached to the distal portion of the hollow shaft. A nose piece disposed at the front face of the balloon forms a connection between the balloon and the distal portion of the hollow shaft. When the balloon is expanded the nose piece does not protrude beyond the front face of the balloon.

Abstract: A method for tissue assessment includes ablating tissue at a site within a body of a living subject using an invasive probe applied to the site. At a first stage in ablation of the tissue, first measurements are made of scattered light intensities from the site at a plurality of different wavelengths. At a second stage in the ablation of the tissue, subsequent to the first stage, second measurements are made of the scattered light intensities from the site at the plurality of different wavelengths. Progress of the ablation is assessed by computing different, respective measures of change in the scattered light intensities at the different wavelengths occurring between the first and second measurements, and comparing the respective measures.

Abstract: Medical catheterization is carried out by introducing a catheter into a heart, sliding the catheter through a sheath that encloses a multi-electrode probe into a chamber of the heart. The sheath is retracted to expose the probe. As the sheath is retracted the exposed probe expands into a spiral configuration, and the electrodes contact the endocardial surface of the chamber at multiple contact points.

Abstract: A medical system includes a shaft, an inflatable balloon, a radial array of ultrasound transducers and a processor. The shaft is configured for insertion into a body of a patient. The inflatable balloon is coupled to a distal end of the shaft and configured to perform a treatment to surrounding anatomy. The ultrasound transducers are distributed circumferentially around the distal end of the shaft inside the balloon, and configured to transmit ultrasound waves at respective radial directions and receive respective ultrasound reflections. The processor is configured to estimate and output to a user, based on the ultrasound reflections received from the ultrasound transducers, an extent of mechanical contact between the balloon and the surrounding anatomy.

Abstract: A method for producing a distal-end assembly of a medical device, the method includes disposing a first layer on at least part of a given section among one or more sections of a flexible substrate. At one or more selected locations on the given section, which are to serve as electrodes on the distal-end assembly of the medical device, a second layer is disposed so that, when brought into contact with tissue, the second layer has a reduced impedance for transferring electrical signals to or from the tissue at a predefined frequency range, relative to the first layer. The given section is shaped to form the distal-end assembly.

Abstract: A manufacturing method includes providing a flat sheet perforated with holes, which have respective initial shapes and respective axes of symmetry. The axes of symmetry of the holes point toward a common origin within the flat sheet. The perforated flat sheet is deep-drawn into a cylindrical shell using a punch centered about the common origin, including deforming the holes from the initial shapes into respective predefined final shapes having different aspect ratios relative to the initial shapes.

Abstract: A method, consisting of providing a metal wire having a wire diameter and an end, and positioning a conductor at a distance from the end of the wire. The method further includes creating an electrical discharge between the conductor and the end, while setting the distance and an electrical potential of the discharge, so as to create a bead of a predefined size on the end. The method also includes assembling the wire with the created bead into an invasive probe, so that the bead is positioned at an outer surface of the probe.

Abstract: A flexible probe has an assembly in its distal end that includes a transmitter and a receiver that receives signals from the transmitter for sensing a position of the receiver relative to the transmitter. A resilient element disposed between the transmitter and the receiver is configured to deform in response to pressure exerted on the distal tip when the distal tip engages a wall of a body cavity.