Abstract: Methods are provided for monitoring and controlling tissue ablation using RF energy delivered by an imaging ablation catheter under direct visualization, using the control and modulation of a set of ablation parameters based on direct optical imaging of the tissue surface via the imaging ablation catheter, where a set of optical image-derived parameters modulates the setting of a subset of Radio Frequency dosing parameters. The ablation dosing algorithms based on image-derived information can be implemented manually or in semi-automated or automated forms.

Abstract: Devices and methods for providing access to the pericardial cavity while reducing risk of myocardial damage. One method includes using an apparatus to apply pressure to a parietal pericardium, retracting the apparatus, and puncturing the parietal pericardium by delivering electrical energy using a puncture device. Another method includes moving a portion of parietal pericardium away from a surface of myocardium of the heart and puncturing the parietal pericardium by delivering electrical energy using a puncture device. The methods may include a step of confirming that the puncture device is at least partially within the parietal cavity by injecting or aspirating fluid through a lumen in the puncture device or measuring the pressure or electrical impedance at the distal end of the puncture device.

Abstract: One described aspect is an optical fiber comprising: a fiber core that extends along a fiber axis, is configured to transmit a laser energy along the fiber axis, and terminates at a distal end with an angled distal face; a jacket that surrounds a proximal portion of the fiber core along the fiber axis, and terminates at a distal end located proximal of the angled distal face; a fiber tip including a proximal end with an angled distal face; and a reflector including a proximal face attached to the angled distal face of the fiber core, a distal face attached to the angled proximal face of the fiber tip, and at least one layer configured to direct the laser energy out of the fiber core along a laser axis generally transverse with the fiber axis, wherein the optical fiber tapers along the fiber axis. Associated laser systems are also disclosed.

Abstract: A probe tip for communicating and laterally directing electromagnetic radiation comprises a waveguide, a primary capsule, a compressible member and a malleable secondary capsule. The waveguide is configured to communicate electromagnetic radiation and includes a beveled surface at a distal tip for redirecting electromagnetic radiation in a lateral direction. The primary capsule is attached over the distal tip of the waveguide. The compressible member covers a portion of the primary capsule. The malleable secondary capsule is positioned over the primary capsule and the compressible member, and includes a crimp that compresses the compressible member against the primary capsule and secures the secondary capsule to the primary capsule.

Abstract: A method of performing a percutaneous multi-probe treatment includes: acquiring a scan image of an object to be treated with multi-probe percutaneous insertions; determining a first point in a region of interest (ROI) in the scan image; determining a second point at a surface of the object in the scan image; generating a reference trajectory by connecting the first point and the second point; arranging, around the first point, a number of third points corresponding to tips of probes to be inserted into the object; generating planned insertion trajectories for the probes based on the number of probes to be inserted and the reference trajectory; and causing a monitor to display superposed on the scan image, at least one of the planned insertion trajectories. The planned insertion trajectories extend in a geometric relationship to the reference trajectory and pass through the third points and through one or more second points.

Abstract: Registration of a surgical image acquisition device (e.g. an endoscope) using preoperative and live contour signatures of an anatomical object is described. A control unit includes a processor configured to compare the real-time contour signature to the database of preoperative contour signatures of the anatomical object to generate a group of potential contour signature matches for selection of a final contour match. Registration of an image acquisition device to the surgical site is realized based upon an orientation corresponding to the selected final contour signature match.

Abstract: Medical software tools platform utilizes a surgical display to provide access to specific medical software tools, such as medically-oriented applications or widgets, that can assist those in the operating room, such as a surgeon or surgical team, with a surgery. In particular, an optical sensor located within an endoscopic camera may register the momentary change in the optical characteristics reflected from a tissue surface and in turn transmit the information to a medical image processing system which can also receive patient heart rate data and display relevant anomalies. Changes in various spectral components and the speed at which they change in relation to a source of stimulus (heartbeat, etc.) may indicate the arrival of blood, contrast agents or oxygen absorption. Combinations of these may indicate various states of differing disease or margins of tumors, and so forth. Also, changes in temperatures and the speed of change may indicate subsurface anomalies.

Abstract: Robotic guide for slender elongated medical device (SEMD) includes first and a second guide mechanisms, each including a pair of adjacent control plates. First and second transverse guide slots defined in pairs of adjacent control plates control a position of an SEMD guide having a spherical outer bearing surface. The guide position is controlled by selectively varying a relative position of the adjacent control plates, whereby robotic control is obtained over both a lateral displacement of an SEMD axis and an insertion angle of an SEMD alignment axis.

Abstract: A control unit is provided for a surgical robot system, including a robot configured to operate an end-effector in a surgical site of a patient. The control unit includes a processor configured to transmit acquired live images of a patient, received from an image acquisition device, to a virtual reality (VR) device for display; to receive input data from the VR device, including tracking data from a VR tracking system of the VR device based on a user's response to the live images displayed on a viewer of the display unit of the VR device; to process the input data received from the VR device to determine a target in the patient; to determine a path for the end-effector to reach the target based upon the live images and the processed input data; and to transmit control signals to cause the robot to guide the end-effector to the target via the determined path.

Abstract: A system includes a robotic manipulator comprising an arm and an end effector coupled to the arm and being moveable by the arm for interacting with a target site in a manual mode and an autonomous mode of operation. A navigation system is configured to track a position of the end effector and the target site. One or more controllers are configured to define a first virtual boundary relative to the target site, prevent the end effector from penetrating the first virtual boundary in the manual mode, and allow the end effector to penetrate the first virtual boundary in the autonomous mode.

Abstract: A method of using a robotic guidance system for performing surgery on a spine is provided. The method includes utilizing a computerized tomographic scan image of a location on a spinal column of a patient, such that the computerized tomographic scan image is connected to a computer and visible on a monitor connected to the computer. The method also includes attaching a coupling component to the spinal column of the patient, coupling a marker to the coupling component, and imaging, with a fluoroscope, the view of the spinal column of the patient, wherein the fluoroscope image is transmitted to the computer and visible on the monitor and the at marker is clearly visible in the fluoroscope image.

Abstract: The present invention provides a system for identifying at least one surgical procedure, comprising: a. at least one robotic manipulator connectable to said at least one surgical tool; b. at least one imaging device configured to real time provide at least one image in a field of view of a surgical environment; c. processor in communication with said robotic manipulator and said imaging device; and, d.

Abstract: A system and method for rapid halt and recovery of motion deviations in a medical device includes a computer-assisted medical device having a first repositionable arm having one or more first repositionable elements, a second repositionable arm having one or more second repositionable elements, and a control unit communicably coupled to the first and second repositionable arms. The control unit is configured to control motion of the first repositionable arm and the first end effector based on a desired motion, monitor an actual motion of the first repositionable arm and the first end effector, determine whether the actual motion deviates from the desired motion by more than a predetermined threshold, and halt motion of the first repositionable arm and the first end effector, or of the second repositionable arm and the second end effector, when the actual motion deviates from the desired motion by more than the predetermined threshold.

Abstract: An instrument drive assembly includes a housing assembly and a coupling assembly. The housing assembly includes a drive assembly. The coupling assembly releasably couples an instrument drive shaft to a drive member of the drive assembly and an instrument sleeve of the surgical instrument to the housing assembly. Actuation of a retention mechanism of the coupling assembly between a locked and unlocked configuration couples and decouples the instrument sleeve of the surgical instrument therewith.

Abstract: A device or scope device is disclosed. The device may comprise: a handle body extending along an axis between first end and a second end; an actuator at the first end of the handle body; a catheter at the second end of the handle body; and a processing unit communicable with a plurality of devices to: switch-in the actuator for control of one device of the plurality of devices; configure, with the actuator, a setting of the one device, control, with the actuator, the one device based on the setting, and switch-in the actuator for control of another one of the plurality of devices. Related devices and methods also are disclosed.

Abstract: A method and system for organizing surgical instruments and supplies in an operating room in preparation for surgery using a system having two tray devices. Each tray includes at least one flat work surface disposed in a first reference plane; an edge feature surrounding the at least one flat work surface, the edge surface standing proud at a predetermined first positive offset distance from the first reference plane, the edge feature comprising at least a work-surface-side wall intersecting the at least one flat work surface at substantially about 90-degrees at a top surface coupled to the work-surface side wall, wherein the top surface disposes generally parallel to the first reference plane and is further defining the first positive offset distance measured from the reference plane; and at least one recessed compartment comprising a bottom surface disposed parallel to the first reference plane and offset therefrom at a first negative offset distance.

Abstract: The invention comprises a surgical instrument assembly for minimally invasive surgery. The surgical instrument assembly comprises a light emitting arrangement and a surgical instrument. The surgical instrument has a distal end and a proximal end and comprises a handle portion at its proximal end and a grasper at its distal end, the grasper comprising at least two jaws and having a closed grasper position and an open position where a grasping space is formed between the jaws. The light emitting arrangement comprises a light source for generating light and a projector for projecting at least a beam of light comprising a string shape perpendicular to the optical axis of the beam of light. At least the projector of the light emitting arrangement is at least temporally fixed to the surgical instrument proximally to the jaws and is arranged to project the string shaped beam of light such that it will be broken upon a lateral movement of an object into the grasping space.

Abstract: A system and method for marking sites of biopsied tissues using markers, such as radiopaque microspheres, ink-like stain, and radio-frequency identification chips, delivered to the site of the biopsy by a construct advanced through a port in a colonoscope and locatable by x-ray equipment, a camera attached to a colonoscope, or a radio-frequency identification chip reader.

Abstract: A marker for use in a living body includes an indicator part to be placed in a living body for a predetermined period of time, and the indicator part is configured to indicate information on the living body or information on the indicator part by means of a difference in X-ray image. Thus, there are provided the marker for use in a living body and an instrument set for inserting the marker for use in a living body capable of identifying a predetermined site in a living body easily and accurately.

Abstract: A system for aerating a marker material. The system includes a first container, a second container, and an aeration connector. The aeration connector includes a body and a screen disk disposed within the body. The first container is in communication with the second container via the aeration connector. The screen disk of the aeration connector is configured to aerate a marker material as the marker material is repeatedly passed between the first container and the second container.

Abstract: A system for disinfecting a medical device is provided. The system includes a light source that generates light having at least one wavelength between about 100 nm and about 500 nm. The system further includes at least one cylindrical optical diffuser disposed in optical communication with at least one interior channel of a medical device, the at least one cylindrical optical diffuser having an outer surface and an end optically coupled to the light source. The at least one cylindrical optical diffuser is configured to scatter guided light through the outer surface to form a light diffuser portion having a length that emits substantially uniform radiation over its length.

Abstract: A system for dental tissue treatment includes a system for directing a laser beam to an area of dental tissue to be treated, and a fluid-delivery system for directing and controlling a flow of a fluid. The fluid is directed to at least a portion of the area to be treated and the fluid flow is controlled to substantially prevent both a change in laser energy absorption by the dental tissue and attenuation of treatment efficiency due to fluid interference with the laser beam. The fluid present in at least a portion of the area to be treated may prevent or reduce the likelihood of melting of enamel in that area.

Abstract: Method of producing a medical cutting tool and a medical cutting tool that will not rust and that is capable of stably demonstrating high strength. A working section formed by a cemented carbide or ceramic is brazed to the tip of a shank part formed by a round bar-shaped austenitic stainless steel, thereby constituting a cutting tool. The shank part includes a shank, a neck, and a joint to which the working section is brazed. At least part of the stainless steel near the joint of the neck and in the joint has a fiber-like structure. The structure of the stainless steel in the joint on the working section side has a granular structure.

Abstract: A heater assembly made of positive temperature coefficient (PTC) material such as barium titanate ceramic that may be self-regulating. A dental compule that holds a dental (e.g. composite) material may be made from thermally conductive plastic and/or electrically conductive plastic that is self-heating when an electric current is passed through the compule. A compule may be generally cylindrical and include an electrically conductive polymer that may exhibit PTC characteristics while generating heat when electric current is applied to the polymer, two flat contact areas each disposed along one portion of the generally cylindrical compule, an orifice or opening positioned at one end of the compule, an inner chamber; and extrudable dental material held within the inner chamber.

Abstract: The invention relates to a dental applicator comprising an applicator housing and a plunger body guided movably in said applicator housing, wherein the applicator housing comprises a connection for detachably mounting a cannula in a pressure-resistant manner, said cannula comprising a connection body and a cannula tube that is rigidly connected in or on said connection body, and the applicator housing (12) and/or plunger body (14) having a receiving device (22) for at least partially receiving a bendable cannula tube (20).

Abstract: The present invention relates to systems and methods of developing and tracking delivery and patient progression through an orthodontic treatment plan. One method includes identifying deviations from an orthodontic treatment plan, including receiving a digital representation of an actual arrangement of a patient's teeth after an orthodontic treatment plan has begun for the patient and prior to completion of the orthodontic treatment plan. The method further includes comparing the actual arrangement to a pre-determined planned arrangement to determine if the actual arrangement substantially deviates from the planned arrangement, the comparing comprising matching teeth from a previously segmented model to a surface of an unsegmented representation of the actual arrangement; and calculating one or more positional differences between the actual and planned arrangements of at least some of the corresponding teeth.

Abstract: The present invention provides methods and systems including orthodontic tooth positioning appliances. An exemplary appliance can include teeth receiving cavities shaped such that, when worn by a patient, repositioning the patient's teeth from a first arrangement toward a subsequent or target arrangement. Appliances can include a cavity having one or more shaped features or protrusions shaped and/or positioned so as to apply a desired force to a patient's tooth received in the cavity and move the tooth along a desired path or direction.

Abstract: A dental implant (1), in particular for insertion into bone tissue of a patient, comprising: a core body (2) having an apical end (4), a coronal end (6), and an outer surface (8) extending along a longitudinal direction between said apical end (4) and said coronal end (6); and at least one thread (12) located on at least a threaded portion of said outer surface (8), should have superior properties regarding primary and secondary stability.

Abstract: Devices and methods to perform elevation of the Schneiderian membrane in a safe, easy and minimally invasive manner are described. The devices include a cannula and a balloon. A liquid can be introduced through the cannula inside the maxillary sinus below the Schneiderian membrane to elevate the Schneiderian membrane. The balloon can be inflated through the cannula so the balloon will be expanded inside the maxillary sinus below the Schneiderian membrane while being surrounded by the liquid which was previously introduce inside the maxillary sinus. The expansion of the balloon is safely further elevating the Schneiderian membrane in a controlled amount and location.

Abstract: Methods and systems for scanning an intraoral cavity of a patient provide capturing one or more viewfinder images of the intraoral cavity and scanning the intraoral cavity with an intraoral scanner to generate one or more topography scans of the intraoral cavity. The one or more topography scans may correspond to the one or more viewfinder images. The methods and systems further provide capturing a viewfinder image of a portion of the intraoral cavity, the viewfinder image overlapping with the one or more viewfinder images. An area of overlap of the viewfinder image with the one or more viewfinder images can be determined. One or more indicators of the area of overlap can be displayed on one or more locations of a display in order to provide guidance for positioning a field of view of the intraoral scanner.

Abstract: Data from an intraoral scan is received, the data comprising a plurality of intraoral images of a dental site. At least two intraoral images are identified that comprise a representation of at least a portion of a non-rigid object that was affixed to the dental site at a target area. Image registration is performed between the at least two intraoral images using the non-rigid object identified in the at least two intraoral images. A 3D model of the dental site is generated based on the image registration. A representation of the non-rigid object is subtracted from the 3D model based on the known properties of the non-rigid object. A surface of a portion of the dental site is interpolated where the non-rigid object was located based on a) data for other portions of the dental site and b) the surface of the base of the non-rigid object.

Abstract: A compact oral hygiene device comprises a unique mini constant jet pump which integrated with a motor, has three diaphragm chambers, draws the fluid from a reservoir and propels fluid out from a buffer room to tips at constant pulseless, high efficiencies and low noise; and a plurality of exchangeable tips cleanses teeth and the interdental area.

Abstract: A method (300) for providing feedback to a user of an oral cleaning device (10). The method includes the steps of: (i) receiving (330), from a sensor (28) of the oral cleaning device, data about a plurality of orientations of the oral cleaning device within the user's mouth during a cleaning session; (ii) extracting (340), from the received data, information about one or more stable orientations of the oral cleaning device within the user's mouth during the cleaning session, where a stable orientation is an orientation of the oral cleaning device maintained by the user for a period of time above a threshold; (iii) fitting (350) the information about the one or more stable orientations of the oral cleaning device to one or more expected orientations; and (iv) providing (360) feedback to the user about the cleaning session based on an analysis of the fitted one or more stable orientations.

Abstract: An oral cleaning device comprising a handle portion (12) with a plurality of indicia (15) and a plurality of illuminating elements (31); and a user interface assembly (24), the user interface assembly including an interface panel (26) and a baffle assembly (30), the baffle assembly including a plurality of baffle sections (49) each corresponding with a respective one of the plurality of illuminating elements and a respective one of the plurality of indicia, and further where each of the plurality of baffle sections including a cover portion (49a) covering the baffle section and positioned between the respective one of the plurality of illuminating elements and the respective one of the plurality of indicia. The user interface assembly is structured to be blank when the device is powered off, and to illuminate one of the indicia when the device is powered on.

Abstract: Biocompatible coatings and spin finishes that can be applied to polyhydroxyalkanoate (PHA) polymers, and medical devices made from PHA polymers, have been developed. The coatings impart good lubricity to PHA polymers, particularly to fibers and braids made from these materials, making the coatings ideal for use on medical devices such as PHA braided sutures. The spin finishes can be applied to PHA fibers to facilitate their manufacture, and also for their conversion to other products, including medical textiles. The spin finishes serve to protect multifilament fiber bundles, and keep them intact following extrusion, and also to impart lubricity to the fiber bundles and monofilament fibers so that they are not damaged in subsequent processing steps particularly in textile processing. The coating reduces tissue drag of, for example, braided sutures.

Abstract: A device and method for delivering a synthetic mesh or graft for anatomical repair at a defect site. A plurality of flexible arms is connected to the synthetic mesh or graft. Grasping jaws are individually controlled at or near a proximal end of the device for connection of the graft and release of the graft at the surgical site. The flexible arms, with graft attached are positioned through a surgical incision to the defect site. An actuator positions the flexible arms to assume a radial array at the surgical site, unfolding and spreading the graft for attachment. The length of each flexible arm is individually adjustable to adapt to the size and shape of the graft selected for installation at the defect site to repair the defect.

Abstract: The present invention provides a warp-knitted fabric and a medical material that can be simultaneously extended in all directions by causing thread made of a second bioabsorbable material to be absorbed in a living body over time and in which the degree of extension can be increased.

Abstract: The invention relates to a device (1) and method for selecting the size and shape of a prosthesis and/or for determining the location of marks to be made on the external face of the skin of a patient intended to receive such a prosthesis, for example for repairing a hernia, comprising a sheet (2) of transparent material, the said sheet comprising: —a plurality of graphical representations (3a, 3b, 4a, 4b, 5a, 5b, 5c, 5d) concentrically embodying the respective outlines of various shapes and sizes of prosthesis, —a plurality of first holes (6a, 6b, 6c, 6d, 6e, 7a, 7b, 7c, 7d, 7e) arranged along the transverse line passing through the centre of the said sheet, and —a plurality of second holes (8a, 8b, 8c, 8d, 8e, 8f, 8g, 9a, 9b, 9c, 9d, 9e, 9f, 9g) arranged along the longitudinal line passing through the centre (C) of the said sheet.

Abstract: The present invention relates to a prosthesis (1) for the repair of an inguinal hernia, which prosthesis (1) is intended to be implanted by a posterior or open laparoscopic route and comprises: an openworked textile (2) made of biocompatible material, comprising a first face (2a) intended to be placed facing the biological tissues of the inguinal region, and a second face (2b) arranged opposite said first face and intended to be placed facing the peritoneum, said first face being provided with fastening means that are able to fix said textile in said biological tissues of the inguinal region, characterized in that at least a part of said second face (2b) is covered with a non-porous coating (7) composed of a material that is hydrosoluble at 37° C. and non-hydrosoluble at 25° C. The invention also relates to a method for producing such a prosthesis.

Abstract: Vascular treatment devices and methods include a woven structure including a plurality of bulbs that may be self-expanding, a hypotube, for example including interspersed patterns of longitudinally spaced rows of kerfs, and a bonding zone between the woven structure and the hypotube. The woven structure may include patterns of radiopaque filaments measureable under x-ray. Structures may be heat treated to include various shapes at different temperatures. The woven structure may be deployable to implant in a vessel. A catheter may include a hypotube including interspersed patterns of longitudinally spaced rows of kerfs and optionally a balloon. Laser cutting systems may include fluid flow systems.

Abstract: Vascular treatment devices and methods include a woven structure including a plurality of bulbs that may be self-expanding, a hypotube, for example including interspersed patterns of longitudinally spaced rows of kerfs, and a bonding zone between the woven structure and the hypotube. The woven structure may include patterns of radiopaque filaments measureable under x-ray. Structures may be heat treated to include various shapes at different temperatures. The woven structure may be deployable to implant in a vessel. A catheter may include a hypotube including interspersed patterns of longitudinally spaced rows of kerfs and optionally a balloon. Laser cutting systems may include fluid flow systems.

Abstract: A shunt for regulating blood pressure between a patient's left atrium and right atrium comprises an anchor comprising a neck region, first and second end regions, and a conduit affixed with the anchor that formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism.

Abstract: A catheter assembly is configured to segmentally expand a scaffold. The catheter assembly includes a balloon that is inflated to expand a first scaffold region, is deflated and retracted into the expanded first scaffold region, and then inflated to expand a second scaffold region.

Abstract: The invention relates to a suction stent for introduction into a hollow organ of the human or animal body, preferably into the gastrointestinal tract, in particular the intestine, comprising a tubular hollow body which is open in the longitudinal direction and made of biocompatible material, the tubular hollow body having a fixed diameter at least in its central portion; and a porous shapeable material, preferably a sponge material, which is biocompatible and shapeable in the radial direction, the porous shapeable material radially sheathing the tubular hollow body at least in a section of the tubular hollow body. Further, the invention relates to a method for sealing a leakage, especially an anastomosis, of the hollow organ.

Abstract: A system includes a graft body and a filling structure. The graft body has a fenestration in a side surface through which a support structure is insertable. The filling structure has an internal volume that is tillable with a filling medium and is configured to have a conduit through the internal volume through which the support structure is insertable. The conduit in the filling structure is alignable with the fenestration in the graft body such that the support structure is insertable through both the conduit in the filling structure and the fenestration in the graft body.

Abstract: An apparatus for replacing a diseased cardiac valve is movable from a radially collapsed configuration to a radially expanded configuration. The apparatus comprises an expandable support member and a prosthetic valve secured therein. The main body portion extends between first and second end portions and includes an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region. Each of the wing members includes first and second end portions and a flexible middle portion extending between the end portions. The second end portion is integrally formed with the uyimain body portion. The first end portion is adjacent the circumferential axis and substantially flush with the outer circumferential surface in the radially collapsed configuration. The first end portion extends substantially radial to the outer circumferential surface in the radially expanded configuration.

Abstract: An apparatus for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising an extracellular matrix (ECM) composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.

Abstract: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member. The device further includes an extension member coupled to the anchoring member and having an annular first portion coupled to the anchoring member and a second portion coupled to the first portion. The extension member is folded in a delivery configuration such that the first portion overlaps the second portion. When released from the a delivery catheter, the extension member unfolds such that the first portion extends radially outwardly from the anchoring member and the second portion extends radially outwardly from the first portion.