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: Coronary sinus cannulation apparatus and methods relating to tissue visualization catheters that can locate and/or cannulate a morphological feature within a body lumen, such as the coronary sinus, are described. Such devices can also perform a variety of therapeutic tissue treatments under direct in vivo visualization thereafter. Moreover, such apparatus and methods may also be utilized with guidewires to facilitate delivery into the coronary sinus to eliminate repositioning of the device and/or repeating an entire sequence of operations, consequently improving procedure effectiveness and reducing procedure time.

Abstract: Apparatus and methods for the treatment of atrial fibrillation are described herein where tissue to be ablated may be monitored under direct visualization. Such a system may 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 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 can be pumped into the imaging hood until the fluid displaces any blood leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. An ablation probe may be advanced into the contained region where the tissue may be ablated and monitored for changes in color as well as appropriate positioning.

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 linen 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 all 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: Transmural subsurface interrogation and ablation apparatus and methods are described where tissue to be ablated is monitored while under direct visualization for tissue parameters (e.g., temperature and impedance) prior to, during, or after ablation. Such a system may 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 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 can be pumped into the imaging hood until the fluid displaces any blood leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. An ablation probe and one or more interrogation needles having sensors are advanced into the tissue to be ablated and monitored. Alternatively, a combined ablation and interrogation probe may be used.

Abstract: Visualization apparatus and methods for transseptal access are described herein where intravascular access across a septal wall is facilitated via devices which provide for direct visual viewing of tissue area. Such a system may 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 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 can be pumped into the imaging hood until the fluid displaces any blood leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. Any number of therapeutic tools or a guidewire can be passed through the catheter and into the imaging hood for crossing the septal wall and passing the guidewire or instruments therethrough.

Abstract: Apparatus and methods for endoluminal advancement are described herein. A shape-lockable tissue anchoring assembly generally has an elongate body, a handle assembly, and an anchoring assembly positioned at or proximal to a distal tip of the elongate body. A distal portion of the elongate body may optionally be steerable or curvable. The anchoring assembly may include various expandable or projecting anchoring features to contact and retain tissue relative to the elongate body such that pleated tissue is temporarily immobile relative to the elongate body. This anchoring can be actuated simultaneously with or independently from shape-locking of elongate body. The anchoring assembly can be actuated simultaneously with the shape-locking of the elongate body. Alternatively, the steerable distal portion of the elongate body can be angled against the pleated tissue to retain it while the endoscope is advanced relative to the pleated tissue.

Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Methods and apparatus for performing endoluminal procedures are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: Methods and apparatus for obtaining endoluminal access are provided comprising a steerable endoluminal guide having a variable pivot for altering steering dynamics. In one variation, variable pivoting is achieved by advancing a member having a hard or substantially rigid section to various depths within a lumen of the guide. The hard section resists deformation, thereby reducing or precluding pivoting of the guide proximal of the distal-most depth of hard section insertion. In another variation, the guide comprises one or more pivot wires that terminate at a segment of the guide disposed proximal of the guide's distal outlet. In such a variation, the steering pivot of the guide may be altered by applying tension to at least one pivot wire, while concurrently applying tension to a steering wire that terminates more distally than the pivot wire, and that is radially offset from the pivot wire about the circumference of the guide.

Abstract: Systems, devices and methods for endoscopic procedures are provided involving accessing and manipulating tissues beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body which has one or more independently shape-lockable sections and a variety of instruments which are either built in to the main body or advanceable through lumens which extend through the main body. Such instruments may include scopes, suction instruments, aspiration instruments, tool arms, plicators, needles, graspers, and cutters, to name a few. The ability to steer and shapelock specific sections of the main body enables access to target locations which are typically challenging to reach and provides a stabilized platform to perform a desired procedure at the target location.

Abstract: Disposable shapelocking systems are disclosed herein. A shapelock assembly generally comprises an elongate body defining at least one lumen therethrough for advancement of an endoscope or other endoscopic instruments therethrough. A handle assembly can be actuated to compress nested links against one another to transition the elongate body from a flexible state to a rigid shape-locked state. One or more of the nested links can be made from a particular thermoplastic either alone or in combination with one or more reinforcing structures. Such structures can include a reinforcing ring integrated with the link on an inner, outer, or lower surface of the link. Alternatively, the link can be coated or layered to enhance its strength. Additionally, different portions of the shapelock body can be made from different types of links depending upon the loads imparted upon the various portions of the shapelock body.

Abstract: Methods and apparatus for creating a working space within a patient's stomach are described. The working space is created by internally spreading or pushing the walls of the stomach apart. Advantageously, such spreading is achieved without pressurizing the patient's stomach, i.e. without injecting a pressurized gas or other fluid directly into the stomach. Diagnostic or therapeutic instruments may be deployed within the working space. It is expected that spreading the walls without pressurizing the stomach will facilitate engagement and/or manipulation of the stomach wall for, e.g., endoluminal treatment of obesity.

Abstract: Methods and apparatus for performing endoluminal procedures are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

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: 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: Self-locking removable 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 tissue stabilizing members adapted to stabilize tissue therebetween, an engagement member slidably disposed through the stabilizing members and having a distal end adapted to engage tissue, and a delivery tube pivotable about the tissue stabilizing members. The tissue manipulation assembly optionally may be configured for removable attachment to an endoscope.

Abstract: Removable 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 tissue stabilizing members adapted to stabilize tissue therebetween, an engagement member slidably disposed through the stabilizing members and having a distal end adapted to engage tissue, and a delivery tube pivotable about the tissue stabilizing members. The tissue manipulation assembly optionally may be configured for removable attachment to an endoscope.

Abstract: Multiple removable 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 tissue stabilizing members adapted to stabilize tissue therebetween, an engagement member slidably disposed through the stabilizing members and having a distal end adapted to engage tissue, and a delivery tube pivotable about the tissue stabilizing members. The tissue manipulation assembly optionally may be configured for removable attachment to an endoscope.

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.