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 medical device flexing structure assembly can comprise a multi-core fiber comprising a plurality of cores, and a flexing structure comprising at least one slot. Each of the plurality of cores can comprise a fiber Bragg grating, and the flexing structure can be configured to bend in response to a force imparted on the flexing structure.

Abstract: A medical device is provided comprising a shaft comprising a first segment and a second segment. The first segment is configured to buckle upon application of a first critical force. The second segment includes an outer surface and an inner surface and is configured to buckle upon application of a second critical force. The second critical force is lower than the first critical force. The medical device further comprises a coil disposed radially inwardly of the inner surface of the second segment.

Abstract: A catheter assembly is constructed by reflow bonding an inner liner and an outer layer. The inner liner defines at least one lumen. The inner liner is made of a gamma-irradiated polymeric material that includes a polyether block amide and a gamma radiation activated cross-linking agent.

Abstract: Embodiments of the present disclosure can include a catheter. The catheter can include an elongate shaft including a proximal end and a distal end, the elongate shaft defining a shaft longitudinal axis. The catheter can include a coupler disposed within a distal end of the elongate shaft, wherein the coupler defines a first sensor groove and a second sensor groove in an exterior surface of the coupler and a coupler longitudinal axis. The catheter can include a first and second wire management feature located at a proximal end of each one of the first sensor groove and the second sensor groove.

Abstract: An apparatus for detecting relative positioning of medical devices located within a human body, the apparatus comprising an inner elongate member comprising a plurality of electrodes and a first sensor member, where the first sensor member is located a known distance from each of the plurality of electrodes, and an outer elongate member comprising a first sensor, and an outer sensor member located between the first sensor and an inner wall of the outer elongate member, where the inner elongate member is configured to move within the outer elongate member and the first sensor is configured to sense a signal generated by movement of the inner elongate member relative to the outer elongate member, and a position detection module including an electronic control unit configured to detect a position of the first sensor member relative to the first sensor based on the signal.

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 medical device flexing structure assembly can comprise a multi-core fiber comprising a plurality of cores, and a flexing structure comprising at least one slot. Each of the plurality of cores can comprise a fiber Bragg grating, and the flexing structure can be configured to bend in response to a force imparted on the flexing structure.

Abstract: An medical device, comprising an elongate shaft extending along a shaft longitudinal axis and comprising a shaft proximal portion and a shaft distal portion that is sized and configured for insertion into a body. An active magnetic position sensor can be disposed within the shaft distal portion.

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: Method and devices for delivering pulsed RF ablation energy to enable the creation of lesions in tissue are disclosed. The delivery of RF energy is controlled such that the generator power setting remains sufficiently high to form adequate lesions while mitigating against overheating of tissue. An ablation catheter tip having high-thermal-sensitivity comprises a thermally-insulative ablation tip insert supporting at least one temperature sensor and encapsulated, or essentially encapsulated, by a conductive shell. A system for delivering pulsed RF energy to a catheter during catheter ablation comprises an RF generator and a pulse control box operatively connected to the generator and configured to control delivery of pulsatile RF energy to an ablation catheter comprising at least one temperature sensor mounted in its tip. Also disclose is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using pulsatile delivery of RF energy.

Abstract: The present invention relates to steerable access sheath assembly including at least one electrode. Moreover, the present invention relates to a steerable sheath access device for use in cardiovascular procedures. Embodiments of the present invention including steerable access sheaths or introducers may provide cardiovascular access for various ablation tools and devices for the performance of various ablation procedures or procedures involving alternate energy sources.

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: A splittable sheath for an implantable medical device can include a jacket having an outer diameter and an inner diameter. A lumen can be defined by the inner diameter and extended from a proximal end to a distal end of the jacket. An electrode can be located at the distal end of the jacket. A signal wire can be disposed within the jacket and can be electrically coupled to the electrode. A rail can be configured to shield the signal wire from a cut path of a sheath splitter. In some examples, the sheath can further include a second rail. For instance, the signal wire can be located between a first rail and a second rail along the length of the sheath. The cut path can be located between the first rail and the second rail on a radially opposing side of the sheath from the signal wire.

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: Method and devices for delivering pulsed RF ablation energy to enable the creation of lesions in tissue are disclosed. The delivery of RF energy is controlled such that the generator power setting remains sufficiently high to form adequate lesions while mitigating against overheating of tissue. An ablation catheter tip having high-thermal-sensitivity comprises a thermally-insulative ablation tip insert supporting at least one temperature sensor and encapsulated, or essentially encapsulated, by a conductive shell. A system for delivering pulsed RF energy to a catheter during catheter ablation comprises an RF generator and a pulse control box operatively connected to the generator and configured to control delivery of pulsatile RF energy to an ablation catheter comprising at least one temperature sensor mounted in its tip. Also disclose is a method of controlling the temperature of an ablation catheter tip while creating a desired lesion using pulsatile delivery of RF energy.

Abstract: A medical device is provided comprising a shaft comprising a first segment and a second segment. The first segment is configured to buckle upon application of a first critical force. The second segment includes an outer surface and an inner surface and is configured to buckle upon application of a second critical force. The second critical force is lower than the first critical force. The medical device further comprises a coil disposed radially inwardly of the inner surface of the second segment.

Abstract: An electrode for use on a medical device is disclosed. The electrode may have a main body of electrically conductive material extending along an axis and may have a proximal end and a distal end. The electrode may also include a magnetic resonance imaging (MRI) tracking coil disposed in the body. The MRI tracking coil may comprise electrically insulated wire. A catheter including an electrode, as well as a method for determining the location of an electrode, are also disclosed.

Abstract: An apparatus for detecting relative positioning of medical devices located within a human body, the apparatus comprising an inner elongate member comprising a plurality of electrodes and a first sensor member, where the first sensor member is located a known distance from each of the plurality of electrodes, and an outer elongate member comprising a first sensor, and an outer sensor member located between the first sensor and an inner wall of the outer elongate member, where the inner elongate member is configured to move within the outer elongate member and the first sensor is configured to sense a signal generated by movement of the inner elongate member relative to the outer elongate member, and a position detection module including an electronic control unit configured to detect a position of the first sensor member relative to the first sensor based on the signal.

Abstract: Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a shaft magnetic position sensor disposed along a distal portion of the catheter shaft. In some embodiments, the high-density electrode catheter can include a flexible tip portion located adjacent to the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible framework. In some embodiments, the high-density electrode catheter can include a plurality of electrodes disposed on the flexible framework. In some embodiments, the high-density electrode catheter can include a tip magnetic position sensor disposed on a portion of the flexible framework.

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: 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.