Abstract: A system may comprise a first catheter having a first steerable segment and a second catheter disposed within the first catheter. The second catheter may have a second steerable segment. The system may also comprise an imaging element supported at a distal end of the second catheter, a coil reference sensor supported at a distal portion of the second catheter, and a processor in electrical communication with the coil reference sensor. The processor may be configured to determine a position of a distal portion of the first catheter with reference to the coil reference sensor.

Abstract: Precision control systems for tissue visualization and manipulation assemblies are described herein where such devices may utilize a variety of apparatus and methods for facilitating advancement, articulation, control, navigation, etc. of systems which may be used to visual and/or treat tissue regions. Additionally, methods and devices for enhancing navigation of the device through a patient body are also described.

Abstract: A tissue visualization system comprises a flexible elongate shaft through which a lumen extends. The system also comprises a pliable visualization device coupled to a distal portion of the flexible elongate shaft. The pliable visualization device includes a chamber configured to receive a fluid. The system also comprises a piercing instrument configured to extend through the lumen and to penetrate a surface of the pliable visualization device.

Abstract: A robotic assembly comprises a deployment catheter including a steerable distal region and further comprises a balloon assembly coupled to the steerable distal region.

Abstract: A method of imaging a tissue region may comprise visualizing one or more lesions in vivo over a tissue region within a body through an imaging catheter. The method may further comprise measuring a temperature or an electrical potential of the one or more lesions. The method may further comprise overlaying a gradient indicative of the temperature or the electrical potential upon a visual image of the one or more lesions captured in vivo. The method may further comprise registering ablation parameters to the visual image of the one or more lesions and displaying the visual image with the overlaid gradient and the registered ablation parameters.

Abstract: A method of imaging a tissue region may comprise visualizing lesions over a tissue region via an imaging catheter by viewing the tissue region through a viewing region purged by a fluid and identifying, with a computer, a location of each of the lesions relative to one another over the tissue region. The method may also include registering, with the computer, a unique set of ablation parameters received from a treatment device for lesion generation for each of the lesions and generating, with the computer, a map of the lesions based on the identified locations of the lesions. The method may also include visually displaying the map of the lesions in a common display with a real-time field of view image of a first lesion; and visually displaying the registered unique set of ablation parameters for the first lesion with the real-time field of view image of the first lesion.

Abstract: Off-axis visualization systems are described herein which facilitate the deployment, visualization, and retraction of an imaging element from a catheter. Such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration as well as an imaging element, such as a CCD or CMOS imager, which may be deployed from a low profile configuration into a position which is off-axis relative to a longitudinal axis of the deployment catheter and/or imaging hood.

Abstract: A system for visualizing a tissue region of interest comprises a deployment catheter defining a lumen and a hood coupled to and extending distally from the deployment catheter. The hood has a low-profile configuration within a delivery sheath and a deployed configuration when extended distally of the delivery sheath. The hood in the deployed configuration defines an open area in fluid communication with the lumen. A distal portion of the deployment catheter extends into the open area. An imaging element is coupled to an imager support member. When in the deployed configuration, the imaging element is configured to extend distally of the distal portion while the imager support member extends within the deployment catheter. The imaging element comprises a tapered surface and the deployment catheter comprises a complementary tapered surface. Retraction of the imaging element causes the imaging element to shift radially outward from a longitudinal axis.

Abstract: A system may comprise a first catheter having a first steerable segment and a second catheter disposed within the first catheter. The second catheter may have a second steerable segment. The system may also comprise an imaging element supported at a distal end of the second catheter, a coil reference sensor supported at a distal portion of the second catheter, and a processor in electrical communication with the coil reference sensor. The processor may be configured to determine a position of a distal portion of the first catheter with reference to the coil reference sensor.

Abstract: A manipulation assembly comprises: a delivery catheter having a lumen extending therethrough; and a deployment catheter positioned within the lumen of the delivery catheter. The delivery catheter is manipulatable within multiple planes. The deployment catheter is independently manipulatable with respect to the delivery catheter and includes a first lumen and a second lumen. The assembly further comprises an elongate, flexible visualization element positioned within the first lumen of the deployment catheter and extendable distally beyond the delivery catheter. The visualization element is articulatable with respect to the delivery catheter. The assembly further comprises an ablation probe positioned within the second lumen of the deployment catheter and comprises an illumination tool routed through the deployment catheter. The ablation probe is extendable distally beyond the deployment catheter and is positionable off-axis with respect to a longitudinal axis of the delivery catheter.

Abstract: Electrophysiology mapping and visualization systems are described herein where such devices may be used to visualize tissue regions as well as map the electrophysiological activity of the tissue. Such a system may include a deployment catheter and an attached hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. A position of the catheter and/or hood may be tracked and the hood may also be used to detect the electrophysiological activity of the visualized tissue for mapping.

Abstract: A medical manipulation assembly includes a catheter and distal and proximal steering mechanisms. The catheter includes distal and proximal steerable portions with working channels configured to receive an instrument. The distal steering mechanism is operable to bend the distal steerable portion in a first plane relative to the proximal steerable portion in response to movement of a first portion of the distal steering mechanism about a first axis of rotation and to bend the distal steerable portion in a second plane relative to the proximal steerable portion in response to movement of a second portion of the distal steering mechanism about a second axis of rotation. The proximal steering mechanism is operable to bend the proximal steerable portion by rotational movement of the proximal steering mechanism. Distal pullwires extend between the distal steerable portion and steering mechanism and proximal pullwires extend between the proximal steerable portion and steering mechanism.

Abstract: A manipulation assembly includes a delivery catheter having a lumen extending therethrough and a deployment catheter positioned within the delivery catheter. The deployment catheter is independently manipulatable with respect to the delivery catheter. The assembly further includes a visualization element extendable distally beyond the deployment catheter and an ablation probe comprising an energy transmitting surface positionable to ablate tissue adjacent to a distal end of the ablation probe. The ablation probe is extendable distally beyond the deployment catheter.

Abstract: An apparatus for inhibiting tissue migration during a procedure comprises a deployment catheter defining at least one lumen therethrough and a non-inflatable hood projecting distally from the deployment catheter and defining an open area. The open area is in fluid communication with the at least one lumen. The apparatus also comprises a visualization element disposed within or along the non-inflatable hood for visualizing tissue adjacent to the open area. The apparatus also comprises a tissue grasping end effector positioned within the open area and configured to temporarily engage the tissue adjacent to the open area such that distal migration of the tissue relative to the barrier or membrane is inhibited.

Abstract: A medical manipulation assembly comprises a catheter including distal and proximal steerable portions with working channels. The assembly further comprises a steerable sheath through which the steerable portions extend. A distal steering mechanism, including a first lumen extending along a longitudinal axis of the catheter, bends the distal steerable portion. A proximal steering mechanism, including a second lumen extending along the axis and defined by a wall, bends the proximal steerable portion by rotational movement of the proximal steering mechanism independently of the distal steerable portion. The wall is rotatable about the axis. Distal pullwires extend between the distal steerable portion and the distal steering mechanism. Proximal pullwires extend between the proximal steerable portion and the proximal steering mechanism.

Abstract: A method of cannulating a coronary sinus within a heart chamber includes deploying, from a catheter, an imaging hood to a deployed configuration by extending the imaging hood from a distal end of the catheter and radially expanding the imaging hood to define a constant deployed volume within an open area of the imaging hood. The method further includes positioning a contact edge of the imaging hood and the open area of the imaging hood in the deployed configuration over or upon an ostium of the coronary sinus, displacing an opaque fluid with a transparent fluid from the open area defined by the imaging hood and tissue surrounding the ostium, visualizing the ostium through the transparent fluid by viewing the ostium via an imaging element attached to an inner surface of the imaging hood, and introducing a guidewire through the imaging hood and into the ostium while under visual guidance.

Abstract: Stent delivery under direct visualization utilizing an imaging hood is described herein. A stent may be delivered and placed in or around lesions, e.g., ostial lesions, through a delivery catheter while being directly visualized via an imaging hood. A pre-delivery assessment probe may also be advanced to the desired site for accurate placement of the stent.

Abstract: A tissue manipulation system comprises a reconfigurable hood structure. The hood structure is asymmetric and has a low profile delivery configuration and an expanded deployed configuration which defines an open area bounded at least in part by the hood structure and by an interface surface extending across the hood structure distal end and configured to engage against a tissue region. The open area is in fluid communication with an environment external to the hood structure. The system also includes a catheter in communication with the open area such that introduction of a fluid through the catheter purges the open area of bodily fluid. The interface surface is slanted relative to the catheter longitudinal axis when the hood structure is fully expanded in the expanded deployed configuration. The system also includes an imaging element positioned on the hood structure such that the open area is visualized through the fluid.

Abstract: A tissue visualization system comprises a flexible elongate shaft through which a lumen extends. The system also comprises a pliable visualization device coupled to a distal portion of the flexible elongate shaft. The pliable visualization device includes a chamber configured to receive a fluid. The system also comprises a piercing instrument configured to extend through the lumen and to penetrate a surface of the pliable visualization device.

Abstract: A subcutaneous implantable device for guiding a vascular access member, the device including a channel defined by a through-hole in the device, wherein the channel is configured to guide the vascular access member there-through to a vascular site; and anchoring means adapted for fixedly attaching, in a form of using suture, tissue ingrowth, tissue encapsulation or tissue adhesion, the device to at least one of a dermis or a subcutaneous tissue at a position underneath the dermis to allow repeated access of the vascular access member through the channel to the vascular site, wherein the device is dimensioned to allow the device to be attached through the anchoring means for anchoring the entire device at a distance away from the vascular site, A method of creating scar tissue track for vascular access is also disclosed where the subcutaneous implantable device for guiding vascular access member is first implanted sub-dermally, the dermis is palpated to feel for the device location and orientation, the guiding