Abstract: A medical manipulation assembly comprises a sheath steerable in response to rotational movement of a sheath steering mechanism. The assembly also comprises a catheter extendable through the sheath. The catheter is steerable in response to rotational movement of a catheter steering mechanism. The sheath and catheter are independently steerable. The assembly also comprises a set of control wires. At least one of the sheath or the catheter includes a plurality of lumens with at least two of the plurality of lumens each sized for passage of one of the control wires of the set of control wires. The steerable catheter includes a working channel sized to receive a visualization instrument therethrough.

Abstract: Tissue visualization devices and variations thereof are described herein where such devices may utilize a variety of methods for facilitating clearing of the device of opaque bodily fluids and sealing between the device and the underlying tissue surface. Additionally, methods and devices for enhancing navigation of the device through a patient body are also described.

Abstract: A medical manipulation assembly comprises an elongated distal steerable portion with a distal working channel extending through the elongated distal steerable portion. The assembly also comprises an elongated proximal steerable portion arranged proximally of the elongated distal assembly portion. A proximal working channel extends through the elongated proximal steerable portion. The assembly also comprises a distal steering mechanism to bend the distal steerable portion in response to movement of the distal steering mechanism. The assembly also comprises a proximal steering mechanism to bend the proximal steerable portion, independently of the distal steerable portion, in response to rotational movement of the proximal steering mechanism. The assembly also comprises distal pullwire(s) extending between the elongated distal steerable portion and the distal steering mechanism and proximal pullwire(s) extending between the elongated proximal steerable portion and the proximal steering mechanism.

Abstract: Visual electrode ablation systems are described herein which include a deployment catheter and an attached imaging 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. An electric current may be passed through the fluid such that it passes directly to the tissue region being imaged and the electrical energy is conducted through the fluid without the need for a separate ablation probe or instrument to ablate the tissue being viewed.

Abstract: Complex shape steerable tissue visualization and manipulation catheters and their methods of use of disclosed herein. The deployment catheter may be articulated utilizing various steering mechanisms to adjust a position of a visualization hood or membrane through which underlying tissue may be visualized.

Abstract: Catheter control systems which facilitate the tracking of an angle of deflection of a catheter distal end can be used for any number of procedures where catheter orientation relative to the body is desirable, e.g., in transseptal access procedures where an accurate angle of puncture of the septal wall is desirable. Such control systems may comprise a steerable handle which is oriented relative to the catheter steerable section to provide for consistent catheter articulation upon corresponding manipulation of the steering ring. Another variation may utilize an orientation indicator to track the deflectable distal end. For instance, an orientation marker as visualized through an imaging hood on the distal end may correspond to identical orientation markers on the control handle such that articulation of a steering mechanism in a direction relative to the orientation markers deflects the catheter distal end in a corresponding direction relative to the visualized orientation markers.

Abstract: According to various embodiments, a method and system to obtain access to a blood vessel underneath a skin layer that may preserve lifespan of the blood vessel and reduce executional skill variability may be provided. The method includes placing a guiding portion between the blood vessel and the skin layer; and configuring the guiding portion to receive and guide a needle to reach the same location of the blood vessel repeatedly and consistently; and forming a resultant scarred track between the blood vessel and the skin layer as the guiding portion is resorbed over time. The system includes a vascular access device configurable to first possess strength to penetrate through a tissue layer, subsequently possess flexibility to conform to the surrounding tissue beneath the tissue layer; and a guiding portion which may be resorbable, wherein the inlet includes a larger diameter compared to the outlet.

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: 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: 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 method of ablating a tissue region within a blood-filled environment comprises restraining a fluid within a visualization field in a portion of the blood-filled environment and visualizing the tissue region through the fluid within the visualization field. The method also includes transmitting ablating electrical energy from the fluid into the visualized tissue region.

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: Axial visualization systems which utilize axially aligned imaging instruments for visualizing through an imaging hood purged of blood via a transparent fluid are described where an imaging element extending from a support shaft may be aligned within a working lumen defined through a deployment catheter. The imaging element may be positioned distal to the hood in its collapsed state and within the hood in its expanded state. The imaging element may be configured to seat itself securely within the catheter or to angle itself to adjust the viewing angle. Additionally, a disposable visualization sheath having a transparent lens may also be utilized to house an imaging instrument therein.

Abstract: Visual electrode ablation systems are described herein which include a deployment catheter and an attached imaging 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. An electric current may be passed through the fluid such that it passes directly to the tissue region being imaged and the electrical energy is conducted through the fluid without the need for a separate ablation probe or instrument to ablate the tissue being viewed.

Abstract: Complex steerable catheter visualization and tissue manipulation systems and their methods of use are disclosed herein. The deployment catheter is articulated using various steering mechanisms. Tissue visualization is accomplished from the visualization hood at the distal end of the deployment catheter, the hood having an ability to expand and other features to facilitate visualization and articulation at the tissue surface.

Abstract: Complex steerable catheter visualization and tissue manipulation systems and their methods of use are disclosed herein. The deployment catheter is articulated using various steering mechanisms. Tissue visualization is accomplished from the visualization hood at the distal end of the deployment catheter, the hood having an ability to expand and other features to facilitate visualization and articulation at the tissue surface.

Abstract: Methods and apparatus are provided for diagnosing and treating digestive or other organs (as well as other parts of the body) endoluminally and transluminally, via instruments passed into the GI tract per-orally and/or per-anally. The instruments may, for example, pass transluminally out of the stomach and/or the colon through a breach formed therein in order to conduct diagnostic or therapeutic procedures, such as gastroenterostomy.

Abstract: Epicardial access and treatment systems are described herein where such devices may utilize multiple expanding frame members coupled to a flexible or rigid deployment catheter shaft. The multiple frame members may extend distally to collapse into a low-profile configuration and may further expand or open radially to create a working or surgical field under direct visualization and defined by the frame members and surrounding membrane while retracting any surrounding tissue. Moreover, the distal ends of each frame member may be tapered such that the frame members may close tightly relative to one another forming an atraumatic end. Any number of therapeutic tools can be passed through the catheter for performing any number of procedures on the tissue.

Abstract: Flow reduction hood systems are described which facilitate the visualization of tissue regions through a clear fluid. Such a system may include an imaging hood having one or more layers covering the distal opening and defines one or more apertures which control the infusion and controlled retention of the clearing fluid into the hood. In this manner, the amount of clearing fluid may be limited and the clarity of the imaging of the underlying tissue through the fluid within the hood may be maintained for relatively longer periods of time by inhibiting, delaying, or preventing the infusion of surrounding blood into the viewing field. The aperture size may be controlled to decrease or increase through selective inflation of the membrane or other mechanisms.

Abstract: Tissue visualization device having a fluid barrier is described herein where an imaging hood is temporarily sealed against a region of tissue to be treated while under direct visualization. Such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration. The imaging hood is placed against or adjacent to the tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A field of view of the imaging element can be expanded and the blood can also be purged in part by inflating a balloon beyond the imaging hood where the balloon is integrally formed along an interior surface of the hood.