A method of constructing an inflatable electrode assembly configured for irrigation, comprises: providing a flex circuit having a substrate with a pre-formed aperture, the substrate constructed of a material having a greater heat resistance or a first melting temperature; providing a balloon member with a membrane, the membrane constructed of a material having a lesser heat resistance or a second melting temperature lower than the first melting temperature of the substrate; affixing the substrate to the membrane wherein a surrounding portion of the substrate around the pre-formed aperture masks a surrounding portion of the membrane so as to expose a target portion of the membrane; and applying heat to the target portion of the membrane through the pre-formed aperture of the substrate, wherein the heat applied, without melting the substrate, melts the target portion of the membrane in forming an aperture in the membrane.

A catheter includes an elongated body having a longitudinal axis, a distal assembly distal the elongated body, the distal assembly having a tapered helical form comprising a larger, electrode-carrying proximal loop and a smaller, softer distal loop, and a shape-memory support member extending through at least the proximal loop. For example, the helical loop subtends at least about 720 radial degrees, with the proximal loop subtending about 360 radial degrees, and the distal loop subtending about 360 radial degrees. The softer distal loop with a straight distal end atraumatically guides the distal assembly into a tubular region so that the larger proximal loop can sit on the ostium of the tubular region with improved electrode and tissue contact.

Systems and methods for measuring the magnetic fields generated by renal nerves before and/or after neuromodulation therapy are disclosed herein. One method for measuring the magnetic field of target nerves during a neuromodulation procedure includes positioning a neuromodulation catheter at a target site within a renal blood vessel of a human patient near the target nerves, and detecting a measurement of the magnetic field generated by the target nerves. The method can further include determining, based on the measurement of the magnetic field, a location of the target nerves, a location of ablation at the target nerves, and/or a percentage the target nerves were ablated by delivered neuromodulation energy.

A biopsy device is proposed comprising a shaft and a tubular member. The shaft is movably, i.e. rotatably as well as shiftably accommodated within the tubular member and comprises a spiral at a distal end portion of the shaft, wherein the spiral is formed by a twisted sheet. Such a spiral may be considered as a laterally open thread having no solid core.

A system for measuring cardiovascular data includes an elongate member having a channel, a first expandable member carried by the elongate member and movable between a collapsed state and an expanded state by adjustment initiated externally of a subject, a first sensor disposed on a surface of the elongate member, second and third sensors disposed on a surface of the first expandable, a first optical sensor located at a first location in relation to the distal end of the elongate member and configured for obtaining photoplethsmographic data, and wherein the first expandable member in its expanded state is configured to interface with the subject's larynx for delivery of at least oxygen gas into the respiratory system of the subject, and the second and third sensors are configured to contact tissue in proximity to the larynx when the first expandable member is in its expanded state.

A catheter includes an elongated body, a distal assembly with a shape-memory member defining a generally circular form, and a control handle adapted to actuate a deflection puller wire for deflecting a portion of the elongated body, and a contraction wire for contracting the generally circular form. The generally circular form which carries at least one ring electrode has an off-edge configuration relative to the elongated body such that a longitudinal axis of the elongated body does not intersect the circumference of the circular form and the generally circular form spirals about the longitudinal axis of the elongated body. Moreover, the circular form can have an on-axis configuration such that the longitudinal axis of the elongated body is axially aligned with a central longitudinal axis of the circular form, or an off-axis configuration such that these axes are axially offset from each other. In a more detailed embodiment, the catheter has a distal assembly with a helical form or a crescent form carrying a plurality of irrigated ablation ring electrodes and a plurality of smaller ring electrodes adapted for impedance recording or PV potential recording. A support member with shape memory extends through the distal assembly to provide the helical or crescent form. The support member has a varying stiffness along its length, for example, a decreasing stiffness toward a distal end of the support member. The support member can also be hollow so that it can receive a mandrel whose stiffness is greater than that of the support member.

Systems, devices, and techniques are disclosed for automatically detecting arrhythmia locations. The systems, devices, and techniques include a plurality of body surface electrodes configured to sense electrocardiogram (ECG) data. The systems, devices, and techniques include a processor including a neural network configured to receive a plurality of historical ECG data and corresponding arrhythmia locations determined based on each of the plurality of historical ECG data, train a learning system based on the plurality of historical ECG data and corresponding arrhythmia locations, generate a model based on the learning system. New ECG data may be received from the plurality of body surface electrodes and the processor may provide a new arrhythmia location based on the new ECG data. Additionally, a new coherent mapping adjustment may be provided based on a model that is trained using historical coherent mapping adjustments.

The present invention relates to an ablation assembly (100) to treat target regions of a tissue (41) in organs (44) comprising: an ablation catheter (1) comprising an elongate shaft (13) having a longitudinal main direction (X-X), said elongate shaft (13) comprising at least a shaft distal portion (17), said shaft distal portion (17) comprising a shaft distal portion distal end (19);
said ablation catheter (1) comprising an inner lumen (118) arranged within the elongate shaft (13);
said ablation catheter (1) comprising a shaft ablation assembly (20) fixedly disposed at said shaft distal portion (17), the shaft ablation assembly (20) being configured to deliver both thermal energy for ablating said tissue (41) and non-thermal energy for treating said tissue (41); at least a shape setting mandrel (26) disposed within the ablation catheter (1), the shape setting mandrel (26) being insertable within the inner lumen (118) and removable from the inner lumen (118),
wherein the shape setting mandrel (26) is free to move in respect of the inner lumen (118) avoiding any constraint with said shaft distal portion (17) during the shape setting mandrel insertion,
wherein the shape setting mandrel (26) comprises at least a pre-shaped configuration and the shape setting mandrel (26) is reversibly deformable between at least a straight loaded configuration and said pre-shaped configuration,
wherein, when the shape setting mandrel (26) is fully inserted in the shaft distal portion (17), the shape setting mandrel (26) is configured to shape set said shaft distal portion (17) with said pre-shaped configuration.

Systems and methods for measuring the magnetic fields generated by renal nerves before and/or after neuromodulation therapy are disclosed herein. One method for measuring the magnetic field of target nerves during a neuromodulation procedure includes positioning a neuromodulation catheter at a target site within a renal blood vessel of a human patient near the target nerves, and detecting a measurement of the magnetic field generated by the target nerves. The method can further include determining, based on the measurement of the magnetic field, a location of the target nerves, a location of ablation at the target nerves, and/or a percentage the target nerves were ablated by delivered neuromodulation energy.

A system and method for assessing contact between a medical device and tissue may comprise an electronic control unit (ECU) configured to be coupled to a medical device, the medical device comprising a first electrode and a second electrode. The ECU may be further configured to select the first electrode as an electrical source and the second electrode as an electrical sink, to cause an electrical signal to be driven between the source and sink, to detect respective electric potentials on the first electrode and the second electrode while the electrical signal is driven, and to determine an impedance respective of one of the first electrode and the second electrode according to both of the respective electric potentials.