Abstract: An apparatus and method for diagnosis or treatment of a vessel or organ. The apparatus includes a deformable body such as a catheter having a tissue ablation end effector and an irrigation channel in fluid communication therewith. At least two sensors are disposed within a distal extremity of the deformable body, the sensors being responsive to a wave in a specified range of frequency to detect deformations resulting from a contact force applied to the distal extremity. A microprocessor can be operatively coupled with the sensors to receive outputs therefrom, the microprocessor being configured to resolve a multi-dimensional force vector corresponding to the contact force. In one embodiment, the sensors are fiber Bragg grating sensors, and the wave is injected into the fiber Bragg grating strain sensors from a laser diode.

Abstract: A control handle for a steerable catheter body for navigation of the catheter body through a biological lumen and manipulation at a treatment site. The control handle includes a housing assembly that houses a piston assembly and a resistance adjusting assembly. The resistance adjusting assembly can be adjusted to provide the desired frictional characteristics of the user for control of the resistance between the piston assembly and the housing assembly. In one embodiment, the piston assembly is configured to provide a frictional resistance that varies dynamically to substantially match the restorative force across the range of catheter tip deflection. Other embodiments include a vibrating member that provides tactile feedback to the operator to indicate conditions at the distal end of the catheter, such as contact force.

Abstract: Apparatus is provided for diagnosing or treating an organ or vessel, wherein a device having at optical fiber contact force sensors disposed in a distal extremity thereof and a deflection mechanism configured to deflect the elongate body at a location proximal of the distal extremity. The optical fiber contact force sensors are configured to be coupled to processing logic programmed which computes a force vector responsive to detected changes in the optical characteristics of the optical fiber contact force sensors arising from deflection of the distal extremity resulting from contact with the tissue of the wall of the organ or vessel.

Abstract: A plunger-type control handle for controlling the deflection of a distal tip of a catheter. The control handle includes a spool driven by a gear, the spool being connected to the proximal end of at least one pull wire. For bi-directional deflection, a second proximal end of a pull wire is connected to the spool such that when one of the proximal ends is collected by the spool, the other of the proximal ends is released in an equal amount. The gear is operatively coupled to the plunger and engages a gear rack disposed on the control handle housing, such that when there is relative movement between the housing and the plunger, the gear and spool are rotated. In one embodiment, a switching mechanism is provided that reverses the rotation direction of the gear and spool, thereby providing full stroke resolution of the plunger in each of the bi-directional directions.

Abstract: A method and apparatus that utilizes a force-time integral for real time estimation of lesion size in catheter-based ablation systems. The apparatus measures the force exerted by a contact ablation probe on a target tissue and integrates the force over an energization time of the ablation probe. The force-time integral can be calculated and utilized to provide an estimated lesion size (depth, volume and/or area) in real time. The force-time integral may also account for variations in the power delivered to the target tissue in real time to provide an improved estimation of the lesion size. In one embodiment, the force metric can be used as feedback to establish a desired power level delivered to the probe to prevent steam popping.

Abstract: An elongated surgical manipulator apparatus and method of operating enables determination of the shape of a flexible portion of the elongated surgical manipulator and/or the location of an arbitrary point thereon, as well as a measure of a contact force exerted on a distal portion of the manipulator. A plurality of fiber optics are operatively coupled with the manipulator, each of the fiber optics including a plurality of fiber Bragg gratings for determination of the shape and/or position. Each of the fiber optics further includes a fiber optic strain gauge such as a Bragg grating or a Fabry-Perot resonator at a distal portion of the elongated surgical manipulator that is isolated from the strain associated with the bending of the manipulator. The fiber optic strain gauges at the distal portion may thus be used to detect a force vector (magnitude and direction) imposed on the distal portion.

Abstract: A fiber optic force sensing assembly for detecting forces imparted at a distal end of a catheter assembly. The structural member may include segments adjacent each other in a serial arrangement, with gaps located between adjacent segments that are bridged by flexures. Fiber optics are coupled to the structural member. In one embodiment, each fiber optic has a distal end disposed adjacent one of the gaps and oriented for emission of light onto and for collection of light reflected from a segment adjacent the gap. The optical fibers cooperate with the deformable structure to provide a change in the intensity of the reflected light, or alternatively to provide a variable gap interferometer for sensing deformation of the structural member. In another embodiment, the gaps are bridged by fiber Bragg gratings that reflect light back through the fiber optic at central wavelengths that vary with the strain imposed on the grating.

Abstract: A strain sensing assembly implements thermal management and/or temperature measurement techniques to adequately mitigate against and compensate for temperature changes in optical fiber strain sensors of a distal end of a catheter. In one embodiment, the distal end of the catheter includes an end effector such as an ablation head that introduces significant thermal temperature changes proximate the distal end of the catheter. In one embodiment, a plurality of temperature sensors is utilized for accurate determination of each of a plurality of optical fiber strain sensors. In other embodiments, a single temperature sensor may be utilized by implementing thermal management techniques that adequately reduce temperature differences between the single temperature sensor and the plurality of optical fiber strain sensors.

Abstract: A method and device for determining the transmuriality and/or continuity of an isolation line formed by a plurality of point contact ablations. In one embodiment, a method for determining the size of a lesion (width, depth and/or volume) is disclosed, based on contact force of the ablation head with the target tissue, and an energization parameter that quantifies the energy delivered to the target tissue during the duration time of the lesion formation. In another embodiment, the sequential nature (sequence in time and space) of the ablation line formation is tracked and quantified in a quantity herein referred to as the “jump index,” and used in conjunction with the lesion size information to determine the probability of a gap later forming in the isolation line.

Abstract: An apparatus and method for diagnosis or treatment of a vessel or organ. The apparatus includes a deformable body such as a catheter having a tissue ablation end effector and an irrigation channel in fluid communication therewith. At least two sensors are disposed within a distal extremity of the deformable body, the sensors being responsive to a wave in a specified range of frequency to detect deformations resulting from a contact force applied to the distal extremity. A microprocessor can be operatively coupled with the sensors to receive outputs therefrom, the microprocessor being configured to resolve a multi-dimensional force vector corresponding to the contact force. In one embodiment, the sensors are fiber Bragg grating sensors, and the wave is injected into the fiber Bragg grating strain sensors from a laser diode.

Abstract: Apparatus is provided for diagnosing or treating an organ or vessel, wherein a deformable body having at least two optical fiber sensors disposed in a distal extremity thereof is coupled to processing logic programmed to compute a multi-dimensional force vector responsive to detected changes in the optical characteristics of the optical fiber sensors arising from deflection of the distal extremity resulting from contact with the tissue of the wall of the organ or vessel. The force vector may be used to facilitate manipulation of the deformable body either directly or automatically using a robotic system.

Abstract: A touch sensing catheter having a strain sensor assembly that may resolve the magnitude and direction of a force exerted on a distal extremity of the catheter, the strain sensor assembly being substantially insensitive to bulk temperature changes. A deformable structure having a plurality of optical fibers associated therewith that are strained by the imposition of a contact force transferred thereto. The optical fibers cooperate with the deformable structure to effect variable gap interferometers, such as Fabry-Perot resonators, that vary in operative length when a force is exerted on the deformable structure. The strain sensor assembly is rendered insensitive to bulk temperature changes by matching the coefficient of thermal expansion of the deformable body with that of the optical fibers. The strain sensor assembly may also be configured to mitigate the effects of thermal gradients using various thermal isolation techniques.

Abstract: Apparatus is provided for diagnosing or treating an organ or vessel, wherein a device having at least two optical fiber sensors disposed in a distal extremity thereof is coupled to processing logic programmed to compute a multi-dimensional force vector responsive to detected changes in the optical characteristics of the optical fiber sensors arising from deflection of the distal extremity resulting from contact with the tissue of the wall of the organ or vessel. The force vector may be used to facilitate manipulation of the catheter either directly or automatically using a robotic system.

Abstract: Apparatus is provided for diagnosing or treating an organ or vessel, wherein a device having at least two optical fiber sensors disposed in a distal extremity thereof is coupled to processing logic programmed to compute a multi-dimensional force vector responsive to detected changes in the optical characteristics of the optical fiber sensors arising from deflection of the distal extremity resulting from contact with the tissue of the wall of the organ or vessel. The force vector may be used to facilitate manipulation of the catheter either directly or automatically using a robotic system.

Abstract: A catheter for diagnosis or treatment of a vessel or organ is provided in which a flexible elongated body includes a tri-axial force sensor formed of a housing and a plurality of optical fibers associated with the housing that measure changes in the intensity of light reflected from the lateral surfaces of the housing resulting from deformation caused by forces applied to a distal extremity of the housing. A controller receives an output of the optical fibers and computes a multi-dimensional force vector corresponding to the contact force.

Abstract: A catheter for diagnosis or treatment of a vessel or organ is provided in which a flexible elongated body includes a tri-axial force sensor formed of a housing and a plurality of optical fibers associated with the housing that measure changes in the intensity of light reflected from the lateral surfaces of the housing resulting from deformation caused by forces applied to a distal extremity of the housing. A controller receives an output of the optical fibers and computes a multi-dimensional force vector corresponding to the contact force.

Abstract: The invention relates to a radially expandable multi-layer tubular structure which is intended to be used as a stent and to the production method thereof. The inventive structure comprises an outer layer (1) and an inner layer (2) which are solidly connected to one another. One of the aforementioned layers (2) is provided with hollow channels (3) through the thickness thereof while the other layer is provided with perforations (4). Said channels (3) can be used to alter the mechanical properties of the stent and to house a medicament for the local treatment of the vessel in which the stent is disposed.

Abstract: A catheter for diagnosis or treatment of a vessel or organ is provided in which a flexible elongated body includes a tri-axial force sensor formed of a housing and a plurality of optical fibers associated with the housing that measure changes in the intensity of light reflected from the lateral surfaces of the housing resulting from deformation caused by forces applied to a distal extremity of the housing. A controller receives an output of the optical fibers and computes a multi-dimensional force vector corresponding to the contact force.

Abstract: The invention relates to a radially expandable multi-layer tubular structure which is intended to be used as a stent and to the production method thereof. The inventive structure comprises an outer layer (1) and an inner layer (2) which are solidly connected to one another. One of the aforementioned layers (2) is provided with hollow channels (3) through the thickness thereof while the other layer is provided with perforations (4). Said channels (3) can be used to alter the mechanical properties of the stent and to house a medicament for the local treatment of the vessel in which the stent is disposed.