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: 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: 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: 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: 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: Tissue visualization device and method variations are 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 translucent or transparent fluid is pumped into the hood until the fluid displaces any blood leaving a clear region of tissue to be imaged via an imaging element. Temporary sealing against the tissue can be achieved in a number of ways such as circumferential balloons inflatable within the hood or other sealing techniques. A field of view of the imaging element can be expanded by inflating the balloon beyond the imaging hood.

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: 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 and method variations are 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 translucent or transparent fluid is pumped into the hood until the fluid displaces any blood leaving a clear region of tissue to be imaged via an imaging element. Temporary sealing against the tissue can be achieved in a number of ways such as circumferential balloons inflatable within the hood or other sealing techniques. A field of view of the imaging element can be expanded by inflating the balloon beyond the imaging hood.

Abstract: Catheter orientation control system mechanisms which facilitate the operation of multiple degrees of freedom of a steerable catheter system can be used for any procedure where catheter orientation relative to the body is desirable. Such systems may comprise a handle having a distal portion which is rotatable independently of the remainder of the handle to enable the handle to maintain a stationary configuration relative to the operator while the catheter distal end is torqued in any configuration by utilizing a single hand and/or single finger to effect complex configurations. Orientation indicators may be incorporated to track the deflectable distal end by visualizing the indicators through an imaging hood on the distal end corresponding to orientation markers on the control handle. 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: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Abstract: In vivo visualization systems are described which facilitate tissue treatment by a user in utilizing real time visualized tissue images with generated three-dimensional models of the tissue region of interest, such as the left atrial chamber of a subject's heart. Directional indicators on the visualized tissue as well as the imaging systems may be utilized while other variations may utilize image rotation or manipulation of visualized tissue regions to facilitate catheter control. Moreover, visualized tissue regions may be combined with imaged tissue regions as well as navigational information to further facilitate tissue treatments.

Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Abstract: Apparatus and methods are provided for mapping out endoluminal gastrointestinal surgery, including endoluminal gastric reduction. Mapping is achieved by locally marking the interior of the gastrointestinal lumen at specified locations. In some variations, mucosectomy and/or mucosal ablation are performed to map out endoluminal GI surgery, to facilitate direct endoluminal engagement of underlying muscularis tissue and/or to initiate a wound healing response. Specialized apparatus may be provided to achieve desired spacing and/or positioning of tissue markings, as well as to actually form the markings. Methods of using apparatus of the present invention are provided.

Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Abstract: Electrode placement and connection systems are described which allow for the electrical connection and maintenance of one or more electrodes positioned on a substrate which is subjected to a variety of mechanical stresses. Such a system may include an imaging hood having an aperture through which transparent fluid is flowed and one or more electrodes positioned along or about the hood. As the hood is configured between a low-profile and opened configuration, these electrodes may remain electrically coupled despite the mechanical stresses subjected to the electrodes and the connections thereto.

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: Methods and apparatus for efficient purging from an imaging hood 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: 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.