Abstract: The instant disclosure relates to electrophysiology catheters for tissue ablation within a cardiac muscle. In particular, the instant disclosure relates to an ablation balloon and catheter shaft that deflects to conform to a shape of a target pulmonary vein receiving ablation therapy for a cardiac arrhythmia, for example. The deflection of the catheter shaft enables a lesion line along a circumference of the target pulmonary vein with improved consistency.

Abstract: The instant disclosure relates to electrophysiology catheters for tissue ablation. In particular, the instant disclosure relates to a cryogenic ablation balloon with safety features that facilitate identification of a leak into an interstitial space between inner and outer balloons as part of the ablation balloon catheter assembly, and prevents egress of cryogenic fluid out of the ablation balloon.

Abstract: Aspects of the present disclosure are directed to a unibody intravascular catheter shaft with benefits which may include a reduced diameter, and independently tunable torquability, flexibility, and pushability characteristics. While various embodiments of the present disclosure may be directed to an entire catheter shaft, various specific embodiments of the present disclosure may be directed to a unibody shaft design, which may be implemented in a portion of a catheter shaft. For example, the unibody shaft design may be advantageously implemented in a proximal shaft portion. Moreover, various embodiments of the present disclosure utilize a modular unibody design, which may be utilized for various catheter shaft applications using an outer polymer layer with variable thickness and durometer to achieve application-specific performance characteristics (e.g., catheter shaft flex).

Abstract: Catheter shaft handles and deflection actuators are disclosed. The actuators include at least one pull wire guide wall and a means for anchoring the proximal portion of a pull wire or of a fiber attached to a pull wire. Each actuator is pivotable relative to the catheter handle housing, and may comprise at least one boss for pivoting the actuator relative to the catheter handle housing. The actuators transfer rotational motion based upon user input on a boss into longitudinal motion of a pull wire. The actuators may include a tensioning mechanism comprising a tension adjustment pin and a pin block, wherein the tension adjustment pin is rotatably attached to the pin block to enable adjustment of tension in a pull wire (e.g., during assembly of the catheter handle).

Abstract: Embodiments of the present disclosure include a medical device. The medical device can include a catheter shaft that includes a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. A flexible tip portion can be located adjacent to the distal end of the catheter shaft, the flexible tip portion comprising a flexible framework, wherein the flexible framework is curved about a transverse framework axis that is disposed transverse to the catheter shaft longitudinal axis without application of a force external to the medical device. A plurality of microelectrodes can be disposed on the flexible framework and can form a flexible array of microelectrodes adapted to conform to tissue.

Abstract: The invention relates to an optic-based sensing assembly and a system incorporating the assembly and related use of the assembly. In particular, the invention relates to an optic-based catheter assembly and related system used to determine contact between a catheter and surrounding proximate environment, such as tissue. An embodiment of such a system may, for example, be used for visualization, mapping, ablation, or other methods of diagnosis and treatment of tissue and/or surrounding areas.

Abstract: Methods of manufacturing a flexible force sensor include forming a first sensor part providing a plurality of spaced first electrode plates in an electrically non-conductive material. A second sensor part is also formed and includes a plurality of second electrode plates in an electrically non-conductive material. The second electrode plates are identical to the first electrode plates at least in terms of spacing. The first part is assembled to the second part such that each of the first electrode plates are aligned with and parallel to, yet spaced from, respective ones of the second electrode plates, establishing a plurality of capacitive sensing components. The first electrode plates are movable relative to the corresponding second electrode plates, establishing a variable gap therebetween. The sensor parts can be ring-shaped. The sensor parts can be formed via MEMS techniques, with the non-conductive material being a polymer.

Abstract: Aspects of the present disclosure are directed to, for example, a high-thermal-sensitivity ablation catheter tip including a thermally-insulative ablation tip insert supporting a plurality of temperature sensors positioned within longitudinally-extending sensor channels and a radially-extending sensor channel within the tip insert. The sensor channels position the temperature sensors in thermal communication with a conductive shell that encapsulates, or essentially encapsulates, the ablation tip insert and the plurality of temperature sensors. Also disclosed is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using various ablative energies and energy delivery methodologies.

Abstract: A medical device, system, and method having a flexible shaft and a multi-core fiber within the flexible shaft. The multi-core fiber includes a plurality of optical cores dedicated for shape sensing sensors, and a plurality of optical cores dedicated for force sensing sensors. A tip assembly can comprise a tip electrode and a coupler comprising at least one fiber support tube center. A distal portion of the coupler can be coupled to a proximal portion of the tip electrode. The tip assembly can further comprise a multi-core fiber comprising a plurality of cores and a fiber support tube. A proximal portion of the fiber support tube can be coupled to the at least one fiber support tube center.

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: Aspects of the present disclosure are directed to flexible catheters for both electrophysiology mapping and ablation using a high-density array of electrodes. These catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes, and conduct monopolar and bipolar ablations of the tissue.

Abstract: Aspects of the instant disclosure relate to an electrophysiological catheter system for performing diagnostics and therapies within a cardiac muscle; more specifically, to a wireless force sensor, mounted to an external surface of a catheter shaft, that detects force exerted on a catheter tip and wirelessly transmits a signal indicative of the sensed force to a wireless transceiver in proximity thereto.

Abstract: A catheter with three distinct compression resistance coils, including a body coil and two pull wire coils, is disclosed. The triple coil system can provide maximal resistance to compression of the catheter's proximal shaft, as well as maximization of the curve angle that the catheter tip can achieve. Additionally, the tri-coil catheter can allow for a lower initial compression load and a more flexible proximal shaft. A gap between the outer diameter of the pull wire and the inner diameter of the pull wire compression coil that is equal to about 10-30% of inner diameter of the pull wire compression coil can provide optimal catheter performance.

Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines. Each of the plurality of splines can have a proximal end portion and a distal end portion. The assembly further comprises a first element defining an axis and comprising an outer surface. The outer surface comprises a plurality of slots configured to receive the distal end portion of each of the plurality of splines. The first element is configured such that the distal end portion of each of the plurality of splines may move with respect to each slot. In accordance with some embodiments, the distal end portion of each of the plurality of splines comprises a section configured for engagement with the first element, wherein the section comprises a shoulder.

Abstract: A family of catheter electrode assemblies includes a flexible circuit having a plurality of electrical traces and a substrate; a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the electrode. A non-contact electrode mapping catheter includes an outer tubing having a longitudinal axis, a deployment member, and a plurality of splines, at least one of the plurality of splines comprising a flexible circuit including a plurality of electrical traces and a substrate, a ring electrode surrounding the flexible circuit and electrically coupled with at least one of the plurality of electrical traces; and an outer covering extending over at least a portion of the ring electrode. A method of constructing the family of catheter electrode assemblies is also provided.

Abstract: A catheter system including an accelerometer-based sensing assembly is provided. In particular the present teachings relate to an accelerometer based assembly used to determine contact between a catheter and surrounding proximate tissue, such as cardiac tissue. An embodiment of such a system may, for example, be used for visualization, mapping, ablation, or other methods of diagnosis and treatment of tissue and/or surrounding areas.

Abstract: A steerable introducer has a proximal end and a distal end, and includes a steerable sheath having a proximal end and a distal end. The steerable sheath includes an outer layer extending from the proximal end to the distal end of the steerable sheath, and an inner liner disposed within the outer layer and extending from the proximal end to the distal end of the steerable sheath. A first pair of pull wires is disposed between the inner liner and the outer layer, and extends from the proximal end to the distal end of the steerable sheath. A second pair of pull wires is disposed between the inner liner and the outer layer and extends from the proximal end to the distal end of the steerable sheath.

Abstract: A catheter with three distinct compression resistance coils, including a body coil and two pull wire coils, is disclosed. The triple coil system can provide maximal resistance to compression of the catheter's proximal shaft, as well as maximization of the curve angle that the catheter tip can achieve. Additionally, the tri-coil catheter can allow for a lower initial compression load and a more flexible proximal shaft. A gap between the outer diameter of the pull wire and the inner diameter of the pull wire compression coil that is equal to about 10-30% of inner diameter of the pull wire compression coil can provide optimal catheter performance.

Abstract: An elongate medical device comprising a first lumen, wherein a cross-sectional shape of the first lumen comprises a peanut shape, and a plurality of second lumens, wherein the plurality of second lumens are proximate the first lumen, wherein the first lumen comprises a lumen liner that conforms to the cross-sectional shape of the first lumen, wherein the lumen liner comprises a first material and the elongate medical device comprises a second material, where the first material is different from the second material.

Abstract: A circuit configured for connecting an electrode to a catheter or sheath is disclosed. The circuit includes a member having a longitudinal axis and configured to extend along at least a portion of the length of the catheter or sheath. The circuit further includes a trace printed on the member, where the trace includes at least a longitudinal segment extending generally along at least a portion of the longitudinal axis and a transverse segment extending generally transverse to the longitudinal axis. In an embodiment, the circuit further includes a pad integral with and extending from the circuit proximal the transverse segment of the trace. A catheter or sheath assembly comprising the circuit and an electrode connected to the circuit is also disclosed. A method of forming a catheter or sheath assembly is also provided.