Abstract: Medical devices, methods of manufacturing medical devices, and systems comprising medical devices are provided. The medical device comprises a shaft having a proximal end, a distal end, and a major lumen disposed therein extending between the proximal end and the distal end. The major lumen is configured to receive a second medical device therein. The shaft comprises an inner liner, a generally planar element wrapped in a spiral pattern about the outer surface of the inner liner, and an outer layer. The generally planar element has a longitudinal axis and a plurality of longitudinally extending ribs and comprises a polymeric material.

Abstract: An electrode catheter device with indifferent electrode for direct current tissue therapies is disclosed. An example of the catheter device has a flexible tubing with at least one ablation electrode. The catheter device also may also be used with a sheath for introducing the flexible tubing inside a patient's body. An indifferent electrode on the sheath can provide a ground for a direct current (DC) pulse to deliver electrical energy and create an electrical field adjacent a tissue. Various other embodiments are also disclosed.

Abstract: A method of filtering respiration noise from a localization signal includes acquiring a localization signal from at least one position measurement sensor within a localization field and acquiring an acceleration signal for at least one localization field generator (e.g., a patch electrode). A displacement signal for the field generator is calculated, for example by integrating the acceleration signal twice, and transformed into the frequency domain in order to calculate a fractional power indicative of patient respiration. The fractional power can then be compared to a threshold value, and the localization signal can be filtered if the fractional power exceeds the threshold value. Alternatively, the acquired acceleration signal can be used to gate collection of data points from the localization signal.

Abstract: A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU) configured to acquire magnitudes for a component of a complex impedance between an electrode and tissue, and the power applied to the tissue during lesion formation. The ECU is configured to calculate a value responsive to the complex impedance component and the power. The value is indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, or a predicted tissue temperature. The method includes acquiring magnitudes for a component of a complex impedance between an electrode and tissue and the power applied during lesion formation. The method includes calculating a value responsive to the complex impedance component and the power, the value being indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, and/or a predicted tissue temperature.

Abstract: The instant invention relates generally to catheters and to introducer catheters used to help deliver catheters or other medical devices to locations within the human body. In particular, the instant invention relates to large diameter catheters and introducer catheters having a torque transfer layer that includes at least two flat wires braided into a wire mesh. The flat wires have a width of at least about 0.007 inches and a depth of at least about 0.003 inches. The lumen diameter of the catheter is at least about 6 French. The torque transfer layer provides increased strength, flexibility, and kink resistance.

Abstract: A method of navigating a medical device through a body of a patient includes providing a topography of at least a portion of the body, accepting user input defining a navigation path, robotically navigating the medical device to a starting point on the path, and robotically navigating the medical device along the navigation path to an endpoint. Waypoints defining the navigation path may be input on a graphical representation of the topography using a user interface such as a pointing device or touchscreen. The navigation path may also be defined by tracing a substantially continuous path on the graphical representation. A therapy may be administered while robotically navigating the medical device along the navigation path, either forward or in reverse, or while navigating the medical device along a return path defined by a plurality of virtual breadcrumbs generated as the medical device traverses the navigation path.

Abstract: A system and method for assessing effective delivery of ablation therapy to a tissue in a body is provided. A three-dimensional anatomical map of the tissue is generated and displayed with the map defining a corresponding volume. An index is generated corresponding to a location within the volume with the index indicative of a state of ablation therapy at the location. The index may be derived from one or more factors such as the duration an ablation electrode is present at the location, the amount of energy provided, the degree of electrical coupling between an ablation electrode and the tissue at the location and temperature. A visual characteristic (e.g., color intensity) of a portion of the anatomical map corresponding to the location is then altered responsive to the index.

Abstract: In various embodiments, a catheter comprising an expandable electrode assembly or basket is provided. In specific embodiments, the basket is particularly useful for mapping electrical activity at one or more locations within the heart. The basket can comprise a plurality of bendable or deflectable arms. At least one of the arms may have varied flexibility over its length in the form of one or more discontinuities of stiffness or flexibility at an elbow region or other variances in flexibility over the arm's length. Such variance in flexibility may allow the arm to assume a different bent configuration or respond to external factors more positively than possible with an arm having a static or near static flexibility or stiffness over its length.

Abstract: Embodiments of the present invention provide a catheter that comprises an elongated catheter body (16) and an electrode assembly (10) at the distal end of the catheter body. The electrode assembly comprises a plurality of spines (11), each of the spines having a proximal end connected to the distal end of the catheter and a distal end, the distal ends of the spines being connected at a spine tip junction (13). Each spine includes an elbow (20) having at least one discontinuity in stiffness at an intermediate position between the distal end and the proximal end thereof. The spines include a plurality of electrodes (12). The electrode assembly is collapsible to a collapsed arrangement to fit within a lumen of the elongated catheter body and expandable to an expanded arrangement with the elbows of the spines bending outwardly relative to the proximal and distal ends of the spines.

Abstract: Irrigated ablation catheter assemblies and methods of facilitating parallel irrigation fluid flow along irrigated assemblies includes a catheter, an irrigated ablation electrode assembly, a flow member, and a catheter shaft having a fluid lumen. The electrode assembly includes at least one irrigation passageway and a distal portion. The proximal portion can include a proximal member and the distal portion can include a distal member which is connected to the proximal member. The proximal end of the flow member couples to the catheter shaft and the distal end of the flow member is disposed about the proximal portion of the assembly. Fluid flow is guided at least in part by the member and traverses the outer surface of the proximal portion along the outer surface of the distal portion substantially parallel with the longitudinal axis of the electrode assembly.

Abstract: The present invention is an electrophysiology, RF ablation, or similar catheter (i.e., catheter or sheath) that includes an actuator that significantly increases the length of travel (i.e., steering travel) of the actuation wires, as compared to the length of travel provided by prior art actuators. The catheter includes a hollow flexible tubular body, a pair of actuation wires disposed in a side-by-side relationship in the body, a handle attached to a proximal end of the body, an actuator pivotally mounted to the handle, an arcuate internal gear rack disposed on the actuator, one or more pulleys pivotally mounted on the handle and coaxially coupled to a pinion gear engaged with the gear rack, and a guide block mounted within the handle. The one or more pulleys include a first channel in which the first actuation wire resides and a second channel in which the second actuation wire resides. The actuation wires pass through holes in the guide block, which aligns the wires into their respective channels.

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: A medical device for diagnosis or treatment of tissue is disclosed. The device includes an electronically-controlled tool configured for diagnosis or treatment, an electrical connector, and a computer readable memory. The electrical connector is configured for connection with an electronic control unit and configured to receive control signals, including signals concerning the operation of the tool, from the electronic control unit. The computer readable memory is accessible through the connector. The memory can include a set of programming instructions for control of the tool, and the programming instructions can be configured to be downloadable from the memory upon connection of the electrical connector with the electronic control unit. A system is also disclosed in which the electronic control unit is configured to transmit a data log from memory in the electronic control unit to the memory in the medical device upon the occurrence or detection of a predetermined event.

Abstract: A catheter assembly comprises a deflectable catheter shaft comprising a distal end and a lumen extending therethrough. The catheter assembly further comprises least one pull wire comprising a distal portion comprising a side and a distal end, wherein the side comprises a first side portion and a second side portion. The catheter assembly further comprises a distal pull assembly operatively coupled to the at least one pull wire. The distal pull assembly comprises a longitudinal axis, a first surface, and a second surface. The first side portion of the at least one pull wire is adjacent to the first surface of the distal pull assembly, and the second side portion of the at least one pull wire is adjacent to the second surface of the distal pull assembly.

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: An elongate medical device with independently-deflectable segments and a handle for manually deflecting those segments can include a shaft having a distal segment and proximal segment, at least one proximal segment deflection wire adapted to deflect the proximal segment, at least one distal segment deflection wire adapted to deflect the distal segment independent of the proximal segment, and a handle portion. The handle portion may comprise a first manual actuation mechanism coupled to the at least one distal segment deflection wire and a second manual actuation mechanism coupled to the at least one proximal segment deflection wire. Actuation of the first manual actuation mechanism may impart a tensile force on the distal segment deflection wire to cause the distal segment to deflect, and actuation of the second manual actuation mechanism may impart a tensile force on the proximal segment to cause the proximal segment to deflect.

Abstract: Stabilization systems and methods for various procedures (e.g., tissue ablation procedures) are disclosed. An exemplary stabilization system for use in a medical procedure may include a housing structure having a base portion, the housing structure insertable into a patient's body. The system may also include a securement element on the base portion of the housing structure. The system may also include a deployment mechanism in the housing structure and operably associated with the base portion. The deployment mechanism is operable to extend the base portion so that the at least one securement element engages a tissue in the patient's body after the housing structure is positioned adjacent a target area inside a patient's body. Embodiments of the securement element may include a membrane, a chamber, a frictional surface, at least one needle, peg, gasket, adhesive, and/or a collar.

Abstract: The present invention relates to improved ablation electrodes (10, 10?) and catheter assemblies (12), as well as methods useful in conjunction with irrigated ablation catheters. An irrigated ablation electrode assembly (10, 10?) includes a proximal member (18, 18?) having an outer surface (22), an inner lumen (26, 26?) and a proximal passageway (24). The proximal passageway (24) extends from the inner lumen (26, 26?) to the outer surface (22) of the proximal member (18, 18?). The assembly (10, 10?) further includes a distal member (20) having a distal end (30) and a distal passageway (28) extending from the inner lumen (26, 26?) through the distal member (20) to the distal end (30). Embodiments of the present invention include an irrigated catheter assembly (12) configured to direct irrigation fluid to target areas where coagulation is more likely to occur to, among other things, better minimize blood coagulation and associated problems.

Abstract: A system that interfaces with a workstation endocardial mapping system allows for the rapid and successful ablation of cardiac tissue. The system allows a physician to see a representation of the physical location of a catheter in a representation of an anatomic model of the patient's heart. The workstation is the primary interface with the physician. A servo catheter having pull wires and pull rings for guidance and a servo catheter control system are interfaced with the workstation. Servo catheter control software may run on the workstation. The servo catheter is coupled to an RF generator. The physician locates a site for ablation therapy and confirms the location of the catheter. Once the catheter is located at the desired ablation site, the physician activates the RF generator to deliver the therapy.

Abstract: A medical device comprising a cell including an ablation element and a carrier configured to receive at least a portion of said ablation element is disclosed. The medical device further comprises a tube enclosing the cell. At least a portion of the tube includes a membrane and the tube includes at least one hole proximate the ablation element for facilitating fluid flow. The medical device further comprises a fluid inlet for providing fluid to the interior of the tube. A method of using the medical device is also disclosed.