Abstract: Interlocking tissue anchor apparatus and methods are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. Anchor assemblies can be delivered via the tissue manipulation assembly into or through the tissue. The anchors can incorporate various temporary interlocking features or spacing elements between one another to ensure that an anchor is not prematurely ejected from the needle assembly. This allows the anchor assembly to be advanced distally as well as withdrawn proximally within a deployment sheath while avoiding inadvertently ejecting an anchor.

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: Needle assemblies for tissue manipulation are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. A needle deployment assembly is deployable through the tissue manipulation assembly via a handle assembly, through the tubular member, and into or through tissue. An elongate pusher is translationally disposed within a sheath of the needle deployment assembly and can be urged distally for deploying an anchor assembly from the sheath distal end. The anchor assembly is positioned distally of the pusher within the sheath.

Abstract: Systems for the stabilization of visualization catheters are described herein which facilitate the deployment and retraction of an imaging hood from a catheter. Such systems may include a deployment catheter and an imaging hood having one or more structural elements which may be integrated or advanced into the hood independently of the hood itself. Moreover, additional features such as rapid exchange ports may be integrated along the hood or along the catheter proximal to the hood to facilitate intravascular procedures and treatments.

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: Interlocking tissue anchor apparatus and methods are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. Anchor assemblies can be delivered via the tissue manipulation assembly into or through the tissue. The anchors can incorporate various temporary interlocking features or spacing elements between one another to ensure that an anchor is not prematurely ejected from the needle assembly. This allows the anchor assembly to be advanced distally as well as withdrawn proximally within a deployment sheath while avoiding inadvertently ejecting an anchor.

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: Combination imaging and treatment assemblies are described herein which may utilize a deployment catheter in combination with an endoscopic system. The combined system comprises an open architecture to modularly incorporate any number of imaging devices (such as optical fiber, CMOS or CCD endoscopes) to provide high resolution optical images of tissue within an opaque environment. Additional variations may include an imaging hood or balloon member incorporated upon an endoscope or advanced through an endoscope working channel to visualize and treat tissue through blood.

Abstract: Visualization and treatment of tissue regions via percutaneous access methods and devices are described herein. The system may include a deployment catheter and an expandable imaging hood. In use, the hood may be introduced from outside the patient body through a percutaneous incision and advanced through a subxiphoid pathway, for example, to the heart where entry may be accomplished via an incision through the left atrial appendage. Once within the heart, the hood can be advanced to any chamber to visualize and/or treat tissue by placing the hood against the tissue to be imaged and pumping translucent fluids into the 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. Additionally, any number of therapeutic tools can also be passed through the deployment catheter and into the imaging hood for treating the tissue of interest.

Abstract: Visualization and ablation system variations are described which utilize various tissue ablation arrangements. Such assemblies are configured to facilitate the application of bipolar energy delivery, such as RF ablation, to an underlying target tissue for treatment in a controlled manner while directly visualizing the tissue during the bipolar ablation process.

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 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: Methods and apparatus for preventing tissue migration or tissue “tenting” during transseptal access procedures are described. The underlying tissue wall may be temporarily engaged via any number of mechanisms, e.g., engaging teeth or projections, threaded needle, vacuum, etc., and one or more instruments may be passed through the tissue wall while maintaining engagement with the tissue to provide a counter-traction force. The procedure may be accomplished while under direct visualization within an imaging hood placed against the tissue surface and purged of blood.

Abstract: Apparatus for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

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: Systems and methods for unobstructed, visualization and ablation, particularly of the pulmonary veins, are described herein. Such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration as well as one or more expandable anchors which are temporarily securable within a respective pulmonary vein while allowing blood flow to pass through the anchor unimpeded. With the one or more non-impeding anchors secured within a respective pulmonary vein, ablation of the tissue surrounding the ostium or several ostia may be effected with the catheter while the tissue is under direct visualization.

Abstract: Apparatus for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

Abstract: Apparatus and methods for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

Abstract: Apparatus and methods for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.