Abstract: A medical system (100) is disclosed that provides a respiratory-based control of at least one medical procedure. In this regard, the medical system (100) includes one or more appropriate sensors (108) for providing respiratory data on a patient (104). This respiratory data is utilized by respiration assessment logic (116) to determine if the respiratory data has exceeded one or more respiration thresholds and which may be equated with a “sudden” respiratory event. Identification of such a sudden respiratory event by the logic (116) results in the suspension of the noted medical procedure. Patient respiration data may also be displayed, for instance in a color that depends upon its magnitude or level.

Abstract: A system and method are provided for determining electrophysiological data. The system comprises an electronic control unit that is configured to receive electrical signals from a set of electrodes, receive position and orientation data for the set of electrodes from a mapping system, compensate for position and orientation artifacts of the set of electrodes, compose cliques of a subset of neighboring electrodes in the set of electrodes, determine catheter orientation independent information of a target tissue, and output the orientation independent information to a display.

Abstract: The present invention pertains to multiple piece irrigated ablation electrode assemblies wherein the irrigation channels are insulated or separated from at least one temperature sensing mechanism within the distal portion of the electrode assembly. The present invention further pertains to methods for improved assembly and accurate measurement and control of the electrode temperatures while effectively irrigating the device and target areas.

Abstract: A method of manufacturing a flexible tubular body for a medical device includes extruding an inner layer from a thermoplastic polymer, pulling it over a mandrel, and tightening it down. If wire lumens were not formed in the inner layer when extruded, polymer spaghetti tubes with wire lumens are laid along the outer surface of the inner layer. Deflection wires are fed into the wire lumens. A wire braid is placed over the inner layer (and spaghetti tubes, if present) and tightened down. The components are encased in an outer polymer layer and a heat shrinkable tube. Pressurized fluid is injected into each wire lumen to maintain the internal diameter thereof greater than the diameter of the deflection wire received therein. Heat is applied to the assembled components, causing the layers to laminate. Once the laminated body has cooled, the heat-shrinkable tube is removed.

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 system and method for generating an electrophysiological map are provided. The system includes an electronic control unit (ECU) configured to receive a signal generated by an electrode disposed at a position on an external surface of the body and indicative of electric potential. The ECU is further configured to identify a surface boundary of an object of interest within the body using an image of the object. The ECU is further configured to identify intervening objects along a pathway between the position on the external surface and the surface boundary of the object of interest from one or more images of the pathway. The ECU is further configured to obtain an impedance value for each of the intervening objects and to determine an electric potential at the surface boundary of the object of interest responsive to the signal from the electrode and the impedance values of the intervening objects.

Abstract: A medical catheter includes a deflectable and compressible catheter shaft; a pull ring near a distal end of the catheter shaft; a distal tip that includes a tip element and a mounting shaft; and an attachment apparatus for securely attaching the distal tip to the catheter shaft, the attachment apparatus including a compression ring which compresses the catheter shaft and the mounting shaft together. The compression ring can be located around the catheter shaft to compress the catheter shaft against an outer surface of the mounting shaft, or within the catheter shaft to compress the catheter shaft outwardly against an inner surface of the mounting shaft. The catheter can be a non-irrigated ablation catheter, with the tip element being a tip electrode, and it can be an irrigated ablation catheter, with the distal tip including a fluid manifold.

Abstract: A system for controlling delivery of ablation energy by an ablation catheter to tissue in a body is provided. The system includes an electronic control unit configured to determine, responsive to a measurement signal from the ablation catheter, a value for a characteristic associated with the delivery of ablation energy to the tissue. In one embodiment, the characteristic is the degree of contact between the ablation catheter and the tissue. The unit is further configured to generate a control signal, responsive to the determined value of the characteristic, to control an amount of energy delivered from an ablation delivery element on the ablation catheter to the tissue. The amount of energy varies in response to the determined value of the characteristic when the determined value of the characteristic meets a predetermined condition relative to a threshold value for the characteristic.

Abstract: An efficient system for diagnosing arrhythmias and directing catheter therapies may allow for measuring, classifying, analyzing, and mapping spatial electrophysiological (EP) patterns within a body. The efficient system may further guide arrhythmia therapy and update maps as treatment is delivered. The efficient system may use a medical device having a high density of sensors with a known spatial configuration for collecting EP data and positioning data. Further, the efficient system may also use an electronic control system (ECU) for computing and providing the user with a variety of metrics, derivative metrics, high definition (HD) maps, HD composite maps, and general visual aids for association with a geometrical anatomical model shown on a display device.

Abstract: A method for registering a catheter navigation system to a three-dimensional image generally includes obtaining a three-dimensional image including position information for a plurality of surface points on a part of a patient's body, using a catheter navigation system to place a tool at a location on the surface of the patient's body, measuring position information for the surface location, identifying a corresponding location on the image, associating position information for the surface location and the location identified on the image as a fiducial pair, and using at least one fiducial pair to generate a mapping function. The mapping function transforms points within the coordinate system of the catheter navigation to the coordinate system of the three-dimensional image such that, for each fiducial pair, the mapping error is about zero. Suitable warping algorithms include thin plate splines, mean value coordinates, and radial basis function networks.

Abstract: A fluid delivery catheter configured to allow optimal fluid distribution through each electrode by varying the diameter of a catheter lumen is disclosed. Uniform or different fluid flow rates through longitudinally spaced apart elution holes may be achieved. Exemplary fluids for use with the catheter include a cooling fluid, a therapeutic fluid, and a medication.

Abstract: An obstruction detection system for a robotic catheter system including a robotic catheter manipulator assembly including one or more catheter manipulation bases and one or more sheath manipulation bases. Each manipulation base may be generally linearly movable on one or more tracks relative to the robotic catheter manipulator assembly. The obstruction detection system may include one or more obstruction detection sensors disposed on the track or on the manipulation bases to detect an obstruction along a path of motion of one or more manipulation bases. A software system may be provided for monitoring movement of the catheter and sheath manipulation bases, and/or a status of the obstruction detection sensors.

Abstract: The invention relates to biocompatible polycarbonate/polyamide polymer compositions for use in medical and surgical devices. Additional additives, crosslinking agents, phosphites, and optionally a radiopaque filler or fillers can be used to produce the high performance compositions desired. The polymer compositions have improved melt processability along with balanced or enhanced physical and mechanical properties, especially when combined or over-extruded onto or covering other polymer layers, such as soft and/or flexible layers commonly used in medical device applications and catheter tips, for example. The ability to incorporate radiopaque compounds into these polymer compositions during melt processing offers improved methods for monitoring and visualizing medical devices when used inside the body and as well as improving the operating characteristics of the medical device components.

Abstract: A medical system for locating a catheter distal tip within a body using a plurality electrical position sensors and a magnetic position sensor in conjunction with an acceleration sensor or rotational encoder. The system locates the catheter by using signals from the acceleration sensor or rotational encoder and magnetic sensors to compensate for positioning errors associated with electric positioning sensors.

Abstract: An embodiment of an elongate medical device may comprise a shaft body having a distal end portion and a proximal end portion and three or more deflection wire assemblies, each deflection wire assembly comprising a flat wire coupled to the distal end portion and configured to deflect the distal end portion. Each flat wire may have a respective length defining a respective deflection radius, wherein each deflection radius is different.

Abstract: A method and system for assessing proximity between an electrode and tissue is provided. The system includes an electronic control unit (ECU). The ECU is configured to acquire values for first and second components of a complex impedance between the electrode and the tissue, and to calculate an electrical coupling index (ECI) responsive to the first and second values. The ECU is further configured to process the ECI to determine the proximity of the electrode to the tissue. The ECU may be configured to calculate an electrical coupling index rate (ECIR) based on the calculated ECI and information relating to the change in location of the electrode, and to assess proximity based on the ECIR. Alternatively, the ECU may be configured to assess the proximity using the calculated ECI, as opposed to the ECIR.

Abstract: A system and method for navigating a medical device within a body are provided. The system includes an electronic control unit configured to determine operating positions for electrical and magnetic position sensors on the medical device within corresponding first and second coordinate systems. The first and second coordinate systems are defined by an electric field based positioning system and a magnetic field based positioning system, respectively. The magnetic position sensor is disposed proximate the electrical position sensor. The ECU is further configured to apply a mapping function correlating the operating positions which generates a mapped position for the magnetic position sensor in the first coordinate system responsive to the operating position of the magnetic position sensor in the second coordinate system. The ECU determines an adjusted operating position for the electrical position sensor in the first coordinate system responsive to the mapped position of the magnetic position sensor.

Abstract: A system for enabling a user to remotely control a robotic medical device system includes a motion capture apparatus to capture motion of a user in a sensing volume and generate indicative output data. The system includes a control unit configured to execute gesture recognition logic that recognizes a user gesture based on analysis of the indicative output data. The control unit executes interpreter logic that is configured to translate the recognized user gesture into a corresponding robotic medical device control command configured to control an aspect of the operation of the robotic medical device system.

Abstract: Systems and methods for aligning directionally operable medical devices with and upon target tissue. Systems and methods for aligning medical devices such as directional ablation catheters to and upon target tissue by monitoring irrigant backpressure. The current disclosure provides solutions to the problem of rotationally or angularly aligning a directional medical device toward tissue.

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.