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: 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 at tacked 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

Abstract: According to embodiments of the present invention, a subcutaneous implant delivery apparatus is provided. The apparatus includes a receiving portion configured to receive a subcutaneous implantable device; and a stabilizing portion configured to cooperate with the receiving portion to hold the subcutaneous implantable device in a fixed position. The receiving portion and the stabilizing portion are movable relative to each other between a released configuration, wherein the receiving portion and the stabilizing portion are configured to move apart from each other to allow the receiving portion to be inserted under a skin layer, and a closed configuration, wherein the receiving portion and the stabilizing portion are configured to move toward each other to allow the subcutaneous implantable device to be held adjacent to the skin layer. According to further embodiments of the present invention, a method of delivering a subcutaneous implantable device for accessing a vascular site is also provided.

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 visualize and/or treat tissue regions. Additionally, methods and devices for enhancing navigation of the device through a patient body are also described.

Abstract: A method of visually locating a vessel within a body lumen comprises displacing an opaque fluid with an inflatable member contained within an open area of a barrier or membrane. The method also comprises positioning the inflatable member against or adjacent to a tissue region at a first location and visually assessing the tissue region at the first location through the inflatable member. The method also comprises repositioning the inflatable member against or adjacent to the tissue region at a second location.

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: 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: 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: 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: A method of inhibiting a flow of a purging fluid from a tissue visualization device comprises positioning an imaging hood attached to a distal end of a flexible elongate shaft in proximity to a tissue region to be visualized The method also comprises introducing the purging fluid into an inflation member suspended within an open area of the imaging hood. The inflation member includes at least one aperture on a proximal portion of the inflation member. The method also comprises inflating the inflation member to a partially inflated state in which the inflation member is circumferentially separated from an inner surface of the hood to form an annular flow path for the purging fluid from the at least one aperture, between the inner surface of the hood and the inflation member, and into fluid communication with an environment external to the hood.

Abstract: Image processing systems are described which utilize various methods and processing algorithms for enhancing or facilitating visual detection and/or sensing modalities for images captured in vivo by an intravascular visualization and treatment catheter. Such assemblies are configured to deliver energy, such as RF ablation, to an underlying target tissue for treatment in a controlled manner while directly visualizing the tissue during the ablation process.

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: 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: Image processing systems are described which utilize various methods and processing algorithms for enhancing or facilitating visual detection and/or sensing modalities for images captured in vivo by an intravascular visualization and treatment catheter. Such assemblies are configured to deliver energy, such as RF ablation, to an underlying target tissue for treatment in a controlled manner while directly visualizing the tissue during the ablation process.

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 and methods are provided for ligating a hemorrhoidal blood vessel for treatment of hemorrhoids. An exemplary apparatus includes a housing having a distal end insertable into the rectum, an ultrasound sensor, suction channel, and suction port on the distal end; and a compression clip, proximate to the suction port and having two clip arms displaceable from each other, the compression clip having an open configuration within the housing yet biased towards a closed configuration, and wherein the compression clip is deployable in the open configuration and configured to close and compress a tissue segment.

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: 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: Devices and methods for treatment of prolapsed hemorrhoidal arteries is disclosed. The devices can identify the hemorrhoid and ligate the artery without causing significant pain or distension of the rectum. The artery can be identified with ultrasound. The ligation can be performed using energy and/or mechanical structures, such as clips or rubber bands.

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.