Abstract: A system for visualizing a tissue region of interest comprises a deployment catheter defining a lumen and a hood coupled to and extending distally from the deployment catheter. The hood has a low-profile configuration within a delivery sheath and a deployed configuration when extended distally of the delivery sheath. The hood in the deployed configuration defines an open area in fluid communication with the lumen. A distal portion of the deployment catheter extends into the open area. The system also comprises an imaging element coupled to an imager support member. When the hood is in the deployed configuration, the imaging element is configured to extend distally of the distal portion of the deployment catheter while the imager support member extends within the deployment catheter.

Abstract: A method of inhibiting flow of a purging fluid from a device comprises positioning an imaging hood in proximity to a tissue region to be visualized. The imaging hood includes a distal membrane which defines a main aperture. The imaging hood and the distal membrane define an open area. The method also comprises introducing the purging fluid into a proximal portion of the open area. The proximal portion is bounded by a proximal membrane including a plurality of apertures. The method also comprises pressurizing the proximal membrane with the purging fluid to a partially extended state in which the purging fluid flows through the plurality of apertures and through the main aperture. The method also comprises pressurizing the proximal membrane with the purging fluid to a blocking extended state in which the proximal membrane obstructs the main aperture to block the flow of the purging fluid through the main aperture.

Abstract: An apparatus may be used for ablating a target tissue region disposed along a tissue surface. The apparatus may comprise a means for directing ablating energy into the target tissue region through the tissue surface and a means for imaging the tissue surface along the target tissue region while selectively directing the ablating energy. The imaging means may be coupled to the energy directing means.

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: 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: A method of inhibiting flow of a purging fluid from a device comprises positioning an imaging hood in proximity to a tissue region to be visualized. The imaging hood includes a distal membrane which defines a main aperture. The imaging hood and the distal membrane define an open area. The method also comprises introducing the purging fluid into a proximal portion of the open area. The proximal portion is bounded by a proximal membrane including a plurality of apertures. The method also comprises pressurizing the proximal membrane with the purging fluid to a partially extended state in which the purging fluid flows through the plurality of apertures and through the main aperture. The method also comprises pressurizing the proximal membrane with the purging fluid to a blocking extended state in which the proximal membrane obstructs the main aperture to block the flow of the purging fluid through the main aperture.

Abstract: A system for visualizing a tissue region of interest comprises a deployment catheter defining at least one lumen therethrough and a hood projecting distally from the deployment catheter. The hood defines an open area that is in fluid communication with the at least one lumen. The system also comprises a delivery catheter sized to extend through the lumen. The delivery catheter includes a distal portion extendable distally from the deployment catheter and into the open area defined by the hood. The distal portion extends distally from the deployment catheter is articulatable within the open area.

Abstract: An apparatus for inhibiting tissue migration during a procedure comprises a deployment catheter defining at least one lumen therethrough and a non-inflatable hood projecting distally from the deployment catheter and defining an open area. The open area is in fluid communication with the at least one lumen. The apparatus also comprises a visualization element disposed within or along the non-inflatable hood for visualizing tissue adjacent to the open area. The apparatus also comprises a tissue grasping end effector positioned within the open area and configured to temporarily engage the tissue adjacent to the open area such that distal migration of the tissue relative to the barrier or membrane is inhibited.

Abstract: A method of treatment comprises intravascularly securing an anchor extending from an anchor member at least partially within a vessel lumen such that blood flows unobstructed through or past the anchor. While the anchor is secured, a distance of the anchor member, between the anchor and a barrier or membrane projecting distally from a deployment catheter, is adjusted such that an open area defined by the barrier or membrane is placed against or adjacent to a portion of a patient tissue. Adjusting the distance of the anchor member comprises moving the deployment catheter distally with respect to the anchor member. The method also comprises displacing blood with a transparent fluid from the open area, and while the anchor is secured, articulating the barrier or membrane circumferentially around the anchor. The method also includes treating the tissue while visualizing through the transparent fluid.

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 system comprises a deployment catheter defining at least one lumen and a hood projecting distally from the deployment catheter and defining an open area. The open area is in direct fluid communication with the at least one lumen. The system also comprises an elongate channel directly coupled to the hood such that the elongate channel terminates distally into the open area. The elongate channel extends proximally from an outer surface of the hood and is bounded proximally at a proximal pocket surface. The system also comprises an imaging element. The imaging element is sized to pass into the elongated channel at a distal end of the elongate channel. Proximal movement within the elongated channel is restricted by the proximal pocket surface. The system also comprises a control member extending within the elongate channel and through the proximal pocket surface for moving the imaging element through the elongate channel.

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: A tissue manipulation system comprises a reconfigurable hood structure with a distal end. The structure has a low profile delivery configuration and an expanded deployed configuration which defines an open area bounded at least in part by the structure and by an interface surface extending across the hood structure distal end. The open area is in fluid communication with an environment external to the hood structure. The system also includes a catheter in communication with the open area such that introduction of a fluid through the catheter purges the open area of bodily fluid. The interface surface is slanted relative to the catheter longitudinal axis when the hood structure is in the expanded deployed configuration. The system also includes an imaging element positioned on the hood structure such that the open area is visualized through the fluid by the element.

Abstract: A method of inhibiting tissue migration comprises positioning an open area of a hood against or adjacent to a tissue region. The method also comprises displacing an opaque fluid with a transparent fluid from the open area. The method includes engaging a portion of the tissue region within the open area via an end effector advanced through the open area and which grasps onto the portion. The end effector includes a tapered section, tapered along its entire length, through which a lumen extends. The tapered section includes threads extending from a surface of the tapered section in a direction orthogonal to the longitudinal axis. The tissue region is pierced while displacing the opaque fluid with the transparent fluid through the distal opening of the hood and while maintaining engagement of the portion of the tissue region such that distal movement of the tissue is inhibited.

Abstract: Systems, apparatuses and methods for stabilizing an implant used in a medical procedure, for example, an implant used to facilitate repeated needling in kidney dialysis. The apparatus may include an implant holder including at least one implant-engaging surface configured to cause compression of skin adjacent the implant. The apparatus may also include a holding mechanism coupled to the implant holder and configured to engage patient anatomy in order to secure the implant holder in place above the implant. In certain implementations, the implant holder may be coupled to an adhesive patch or may be flexible and configured to at least partially conform to the patient anatomy when a strap assembly is tightened around patient anatomy.

Abstract: A system comprises a catheter and an electromagnetic sensor assembly supported at a distal end of the catheter. The electromagnetic sensor assembly includes a magnetic strut spirally extended away from the distal end of the catheter around an open area distal of the catheter. The system also comprises an imaging element supported at a distal end of the catheter inside the open area. The imaging element acquires an image of the tissue surface region. The system also comprises a processor that receives a position of the electromagnetic sensor assembly and the tissue surface image. The processor maps the position of the electromagnetic sensor assembly and tissue surface image together. The system also comprises a barrier reconfigurable from a low-profile shape to an expanded deployment shape projecting from a distal end of the catheter. The electromagnetic sensor assembly is spirally configured over the barrier.

Abstract: A tissue manipulation system comprises a reconfigurable hood structure with a distal end. The hood structure has a membrane extending across the hood structure distal end. The membrane includes an aperture with an aperture diameter smaller than an outer lip diameter of the hood structure in the expanded deployed configuration. The system also includes a fluid lumen in communication with the open area and an inflatable balloon member translatable through the aperture in the membrane and distal to the open area. The system also comprises an expandable stent positioned upon the balloon member. The stent has an unexpanded configuration sized to pass through the aperture in the membrane.

Abstract: A system comprises a steerable sheath including a passageway therethrough and a steerable segment extendable from the passageway. The steerable segment defines a lumen. The system also includes an imaging element extending from a distal end of the steerable segment.

Abstract: A robotic assembly comprises a deployment catheter including a steerable distal region and further comprises a balloon assembly coupled to the steerable distal region.

Abstract: Methods, materials, articles, assemblies, systems, devices, kits and computer hardware/software for improving medical procedures, including, but not limited to, hemodialysis. Particular beneficial designs and uses of disinfecting patches, scab removal patches, hemostatic patches, healing patches and artificial scabs are included. For example, scab removal patches that avoid tenting, hemostatic patches with needle stabilizing elements, hemostatic patches applying pressure at a skin puncture site and a vessel puncture site, artificial scabs that release antimicrobial agents, etc.