Abstract: Systems and methods to prevent leakage of an intestine and/or provide support to an intestine. The systems can carry the leakage protection device on an external surface for delivery or carry the leakage protection device internally within a lumen. The device is delivered into the intestine portions to protect a site where a defect is repaired such as at an anastomotic site.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff annularly disposed about the stent. The prosthetic valve includes a plurality of legs and a sealing portion that are biased to curl upon deployment of the valve to form a sealing ring at a spaced distance from the proximal end of the valve.

Abstract: An anastomosis assist tool comprises a body unit extending in a predetermined advancing direction, and an insertion unit arranged at the tip of the body unit. The body unit includes an anastomosis assist part having an approximately constant cross-sectional shape in a plane perpendicular to the advancing direction. The anastomosis assist part includes a projection projecting outwardly as viewed in the cross section and extending in the advancing direction. The insertion unit includes a tapered part of a diameter decreasing gradually toward a tip. When the insertion unit and a part of the body unit are inserted into a vessel, the projection of the anastomosis assist part of the body unit abuts on the inner wall of the vessel. This makes it unlikely that the inner wall of the vessel will stick to the body unit at a site other than a point abutting on the projection.

Abstract: A prosthetic heart valve includes a radially collapsible and expandable stent, a cuff and leaflets sutured thereto. The heart valve extends axially between an inflow end and an outflow end and the stent includes a layout of struts and nodes having a hybrid combination of vertical struts and oblique struts in the form of diamond-shaped and half diamond-shaped cells. The layout of the structure is configured to preserve a low cell density of material used in the stent to reduce the stent profile while in a collapsed state and to improve the deployment accuracy of the stent into the native valve annulus.

Abstract: Delivery systems for expandable elements, such as stents or scaffolds having spikes, flails, or other protruding features for penetrating target tissue and/or delivering drugs within a human patient are described along with associated methods for using such systems. The delivery systems can be provided with a stent that is positioned over an inflatable balloon for expansion and delivery of the stent to a target delivery location. By positioning the stent over and about the inflatable balloon, the stent is ready to be expanded by the balloon immediately upon unsheathing with respect to the outer shaft. Additionally or alternatively, a stent can be positioned in an axially offset arrangement with respect to a balloon to reduce the need for space required by overlapping components.

Abstract: A vascular anastomosis device includes a vascular fastener having a first ring and a second ring, and a vascular fastening mechanism. The first ring is provided a first groove and the second ring is provided with a first projection. In addition, the vascular fastener is disposed in the vascular fastening mechanism. The vascular fastening mechanism includes a first tube, a vascular supporting unit, an advancing ring, a third tube, and a spreading unit. The first tube is connected with a second tube. The vascular supporting unit is disposed in the second tube. Furthermore, the vascular supporting unit includes a vascular supporting body and a vascular spreader assembled on the vascular supporting body. The first ring, the second ring, and the advancing ring are assembled on the second tube. The third tube is disposed in the first tube. The spreading unit is disposed in the third tube.

Abstract: A tissue lumen stent is provided with a body having an elongated tubular configuration and a foreshortened configuration. In the foreshortened configuration, downstream and upstream ends of the body expand radially into downstream and upstream flange structures, leaving a generally cylindrical saddle region therebetween. In some embodiments, the flange structures are non-symmetrical with respect to one another. Systems and methods of using the stents are also disclosed.

Abstract: A coupling system includes an applicator tool and an attachment ring mounted on the applicator tool. Clips are contained within the applicator tool and are deployed through the attachment ring in order to anchor the attachment ring to biological tissue. When deployed, tips of the clips follow a curved trajectory through an annular cuff of the attachment ring and through the underlying tissue. The tips loop back out of the tissue and to a location where they are later trapped or clamped by the attachment ring. While the tips are trapped or clamped, the applicator tool cinches the clips by pulling rear segments of the clips. Thereafter, the applicator tool disconnects from the attachment ring which remains anchored to the tissue and serves as a coupling for a cannula. The cannula can have movable lock members that secure it to the attachment ring.

Abstract: An endovascular medical system for use with a clot located in a target vessel. The system including a guidewire formed by a core wire. The guidewire extending in a longitudinal direction from a proximal end to an opposite atraumatic clot-circumventing configured distal end; and a lateral direction of the atraumatic clot-circumventing configured distal end of the guidewire being defined transverse to the longitudinal direction of the guidewire. The atraumatic clot-circumventing configured distal end is designed to prevent injury to an inner wall of the target vessel and prohibit insertion of any portion of the guidewire into a perforator vessel.

Abstract: A division position search unit searches for a division position on an edge present on a path from a second end point, which is one of plural end points of a tree structure of a three-dimensional object other than a first end point, toward the first end point, and at the division position, the size of a downstream tree structure spreading from the division position toward a direction opposite to the first end point changing from a size within an output range of a three-dimensional object creation apparatus to a size exceeding the output range. Then, a division unit divides, at the division position, the three-dimensional object into a division object the size of which is within the output range and a remaining object. An output unit outputs the division object to the three-dimensional object creation apparatus.

Abstract: Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium. From an atrium side, the catheter can be anchored to a superior surface of a mitral valve leaflet and a leaflet anchor can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to a leaflet suture. A ventricular anchor is anchored to the wall of the ventricle to secure the ventricular wall to a ventricle suture. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

Abstract: Apparatus is provided, comprising (1) a guide member, (2) a tissue-adjustment mechanism having (a) an upper surface and a lower surface, (b) at least one first opening at the upper surface, (c) at least one second opening at the lower surface, and (4) a channel extending between the first and second openings, the channel facilitating advancement of the tissue-adjustment mechanism along the guide member; and (3) at least one repair chord coupled at a first portion thereof to the tissue-adjustment mechanism and having at least a first end that is configured to be coupled to a portion of tissue of a patient, the repair chord being configured to adjust a distance between the portion of tissue and the tissue-adjustment mechanism, in response to adjustment of the repair chord by the tissue-adjustment mechanism. Other embodiments are also described.

Abstract: Embodiments of the invention provide systems and methods for using a tissue scaffold to facilitate healing of an anastomosis. One embodiment provides a tissue scaffold for placement at an anastomotic site within a body lumen comprising a radially expandable scaffold structure having lateral and mid portions, at least one retention element coupled to each lateral portion and a barrier layer. The retention element engages a luminal wall when the scaffold structure is expanded to retain the structure and exert a compressive force on the anastomosis. The mid portion has a greater radial stiffness than the lateral portions such that when the structure is expanded, the lateral portions engage tissue prior to the mid portion. The barrier layer is configured to engage a luminal wall when the structure is expanded to provide a fluidic seal at the anastomosis. The barrier layer may also include releasable biological agents to promote anastomotic healing.

Abstract: A deployment device for deploying a self-expanding fenestrated stent graft. The device includes a fenestrated stent graft retained on an introducer. The introducer includes a main catheter and an auxiliary catheter preloaded within the introducer and extending from distal the distal end of the stent graft, into the lumen of the stent graft and through the fenestration.

Abstract: A system is described for performing vascular anastomosis without the use of sutures. The system includes a connector comprised of memory material and an incision seal. The connector has one end configured to securely engage a graft vessel and another end with wings and barbs. The wings are configured to securely engage an inner wall of a main vessel and the barbs are configured to lock with the incision seal. Once locked, the incision seal and the connector apply a clamping force that secures the graft vessel with the main vessel.

Abstract: An endovascular stent-graft system (10) includes fenestrated and crossing stent-grafts (20, 22). The fenestrated stent-graft (20) defines first and second lateral apertures (40, 42) in a central portion (34) thereof, which apertures (40, 42) face in generally radially opposing directions. The crossing stent-graft (22) includes one or more covering elements (58), which at least partially cover both end portions (44, 46) of the crossing stent-graft (22), such that a central portion (54) is at least partially uncovered.

Abstract: An implantable flow connector for fluidically coupling a source tissue-enclosed body space with a destination element, comprising: a conduit having a lumen terminating at an orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit implantable in the destination element through an opening in a surface of the destination element; and a circumferential flange, radially extending from the conduit proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening, the flange comprising one or more circumferentially adjacent sections at least one of which has a rigidity that decreases in a radially-increasing direction.

Abstract: A shunt rivet for implantation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease. The shunt rivet may be formed to have a central section, a proximal clinch section, and a distal clinch section each having one or more clinch members. These one or more clinch members may be trained to be resiliently biased to bend radially outwardly from the central section.

Abstract: A vascular anastomosis device comprises two rings with pins and an openable ring holder, which is made of a pair of components and detachably holds the rings. The end portion of a large-diameter blood vessel is inserted through a ring and the vascular wall is extended outward and impaled on the pins, the end portion of a small-diameter blood vessel is inserted through the other ring, and an incision is made from the end surface of the small-diameter blood vessel. The two rings are elliptically deformed so that the minor axis agrees with the diameter of the small-diameter blood vessel, the small-diameter blood vessel is elliptically opened and the vascular wall is extended outward and impaled on the pins, and the two rings are joined together by allowing the pins provided on the ring in one component to stick into the ring in the other component.

Abstract: Methods and apparatus for anastomosis of a lumen according to various aspects of the present invention operate in conjunction with an impermeable stent. The impermeable stent may comprise a scaffold and, if needed, a sealant, such as a membrane and/or adhesive. In one embodiment, the scaffold, membrane and/or adhesive comprise biocompatible materials suitable for bio-absorption and/or degradation.

Abstract: An exemplary anastomosis device comprises a proximal ring, a distal ring, and a middle ring. The middle ring has apertures configured to communicate a fluid such as an adhesive. The exemplary anastomosis device also has arms joining the proximal ring to the center member and arms joining the distal ring to the center member. The anastomosis device is configured to move from an unactuated position, where it has a generally cylindraceous configuration, to an actuated position, where it has a generally rivet-like configuration. The anastomosis device may be used to provide and secure an anastomosis between adjacent tissue walls. Adhesive may be communicated through the apertures of the middle ring of the anastomosis device to seal or strengthen the anastomosis. An applier may be used to deploy the anastomosis device and to communicate the adhesive through the apertures.

Abstract: Devices and methods are disclosed herein for a closure device. A closure device includes a body movable from a pre-deployed configuration towards a deployed configuration, a plurality of tissue-engaging portions extending from the body. At least two of the tissue-engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration in which the first distance is smaller than the second distance. The closure device also includes a plurality of device capture features secured to the body. The device capture features are configured to move the tissue-engaging portions to a separation greater than the first distance.

Abstract: A vascular connector includes: a main tube having a channel for fluid flow therethrough and opposed ends adapted to be connected to a vascular structure; and at least one inlet tube having a channel for fluid flow therethrough, a proximal end intersecting the main tube, and a distal end adapted to be connected to a vascular structure, wherein the inlet tube is formed in a helical shape which surrounds the main tube.

Abstract: The present invention relates to an anastomosis device for blood vessels using a self-expandable material or body, and to an anastomosis method for blood vessels using same, and more particularly, to an anastomosis device for blood vessels using a self-expandable material or body, which is self-expandable in response to external stimulation and which is removable after a procedure, and to an anastomosis method for blood vessels using same.

Abstract: An anastomotic device, particularly a positioning device (24) extending along a longitudinal axis (30) comprises a first component, or proximal component (26) and a second component, or distal component (28). The proximal and distal components are suitable to lock an elastic ring (52) in a deformed configuration therebetween. The proximal component (26) has a substantially cylindrical outer structure with a cavity (32) for receiving a proximal end (52a) of the elastic ring (52). The distal component (28) comprises a head (42) and a stem (44) developing along the longitudinal axis (30). The head (42) has a cone or truncated-cone shape.

Abstract: An implantable connector for suturelessly connecting a conduit to a hollow organ, the implantable connector comprising: a hollow expandable stent, wherein the hollow expandable stent comprises an internal skeleton and a blood-retaining membrane covering the internal skeleton, and wherein the hollow expandable stent is constructed so that it is capable of assuming (i) a diametrically-reduced state for insertion into an opening formed in the side wall of the hollow organ in order to create a first interference fit therewith, and (ii) a diametrically-expanded state for expanding against the side wall of the hollow organ in order to create a second, enhanced interference fit therewith.

Abstract: Devices and methods for attaching an end of a body vessel to another body vessel are disclosed. An adhesive may be used along with a rigid member having one or more protrusions. The invention is useful in surgery, especially vascular surgery and the creation of anastomoses.

Abstract: An endoventricular device includes a backbone and a plurality of segments having a plurality of anchors that are delivered to the treatment site in an inverted delivery configuration within a delivery catheter and when deployed moves from the inverted delivery configuration to a tissue penetrating implantation configuration.

Abstract: Techniques associated with a vascular anastomosis device are described, including a lower flange having a lower gripping surface and an interior surface, a diversion conduit attached to the lower flange, the diversion conduit having a lumen extending between an inlet and an outlet, the inlet forming an opening in the interior surface, an upper flange having an upper gripping surface, and being configured to move from a first position to a second position with respect to the lower flange, the first position being characterized by the upper flange being separated from the lower flange, the second position being characterized by the upper gripping surface being in contact with the lower gripping surface, and a biasing structure configured to exert a force on the upper flange in a direction from the first position toward the second position.

Abstract: A side-to-end vascular anastomosis device comprising a diversion conduit coupled to a lower flange which is inserted into the vessel and an upper flange located on the outside of the vessel designed to clamp together to seal the incision into which the lower flange of the device is inserted.

Abstract: The present invention provides devices for closing septal defects, such as a patent foramen ovale (PFO). The closure devices include a proximal anchor member, a distal anchor member, and at least one flexible center joint connecting the two anchor members. According to some embodiments, the proximal and/or distal anchor members may include a generally cylindrical member split along the central portion of its length to form an elongate oval. The proximal and/or distal anchor members may further include a tissue scaffold. At least some of the closure devices according to the present invention are repositionable and retrievable.

Abstract: The disclosure provides methods for repairing nerves and inhibiting atrophy of a muscle via a side-to side neurorraphy using a bridging element between a first epineurial window on a donor nerve and a second epineurial window on a recipient nerve.

Abstract: Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Abstract: A scaffold is provided for managing access through tissue. The scaffold can support the tissue during medical procedures. The scaffold is placed around or proximate an opening in tissue. The scaffold can expand when medical devices are introduced through the scaffold and through the opening and retract when the medical devices are removed. When the medical devices are removed, the scaffold closes automatically to substantially close the opening.

Abstract: A surgical fastener for use with an anastomosis of two tissues includes a base leg and an upright leg. The base leg is selectively deformable and includes a traumatic tip for piecing tissue. The surgical fastener also includes at least one capillary disposed on the base leg which has a reservoir defined therein for retaining a liquid, e.g., bioadhesive, bonding agent, medicament, etc. Each of the capillaries is ruptureable upon deformation of the surgical fastener to dispense the liquid to the anastomosis site.

Abstract: A device is disclosed that provides for the protection of intestinal anastomosis sites and other body sites from bodily fluids and contaminants. Additionally, the device provides the ability to create negative pressure at the site of the obstruction to ensure that contaminants flow from the visceral compartment into the inner lumen of the bowel. Further, the device provides the sectional forces through natural constrictions of the intestinal muscles through peristaltic action.

Abstract: An apparatus for regulating the functioning of a patient's organ or duct includes an elongated member having a first end and a second end. A fastener is disposed on the first end of the elongated member. The fastener is configured to engage the second end of the elongated member so that the elongated member forms a loop around the organ or duct. A tension element is disposed for movement within the elongated member. A symmetrical drive system including a drive element associated with and engaging the tension element for causing the tension element to control the tension applied by the elongated member against a patient's body organ or duct is further provided. In accordance with an alternate embodiment an apparatus for regulating the functioning of a patient's organ or duct including an elongated member having a first end and a second end. A fastener is disposed on the first end of the elongated member.

Abstract: An environmentally sensitive hydrogel material swells or collapses in response to a parameter such as pH level associated with consumption of food by a patient. This swelling or collapsing is harnessed to treat morbid obesity or some other condition of the patient. The swelling or collapsing of the hydrogel may be used to tighten a gastric band or gastric valve when the patient starts eating; then loosen the band or valve when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to increase the size of a space occupying device in the patient's stomach when the patient starts eating; then decrease the size of the space occupying device when the patient is between meals. The swelling or collapsing of the hydrogel may also be used to selectively restrict the absorption of nutrients within a patient's gastrointestinal tract, such as in the duodenum.

Abstract: A method for open surgical repair of a damaged portion of an artery or vein. A tubular medical assembly may include one or more shaped members, such as microbarbs, configured to anchor into the tunica intima and the tunica media of the vessel wall, and not to the tunic adventitia and vasa vasorum. The medical assembly is delivered to the damaged vessel portion via a delivery device through an open air pathway, and forms a conduit between transected ends of the damaged vessel.

Abstract: Medical devices and related methods are disclosed for delivering an implant into the body of a patient. The devices include a damping assembly having an internal chamber with a varying inner diameter, and a piston slideably disposed therein. The piston is operably connected with a catheter portion such that movement of the piston is associated with concurrent movement of the catheter for implant delivery. The varying inner diameter of the damping assembly results in a decrease in damping force during implant delivery, thus providing a substantially constant velocity of implant delivery.

Abstract: A device is provided for endoscopy or endosonography- guided transluminal interventions whereby two luminal structures in the body may be drawn toward each other and a fluid conduit formed in between. The device may have a penetrating member and a hollow central member to which is coupled a distal retention member and in one embodiment a proximal retention member. The retention members may each be positioned inside one of the luminal structures and expanded from a first condition to an expanded second condition having an increased radius. The length of the central member may be shortened and its diameter expanded to approximate the two retention members and thereby the luminal structures.

Abstract: Methods and devices for a coupler adapted and configured for use with a device insertable within a mammalian body are disclosed. The coupler also can be used as a temporary holding device for indwelling catheters, cannula, introducers or other devices. The coupler may be used to hold a catheter or other, at a fixed or movable length from the outside of a patient. The catheter or other may be inserted through the center of the coupler, with the tissue contacting ridge attached to the skin using an adhesive, suture(s), combination or other. The inside of the coupler may have a valve, ring, gasket or other, that provides fluid sealing as well as mechanical interference fit between the inside of the coupler and the outside of the catheter or other device.

Abstract: The present invention relates to an assembly comprising: a ring having anchoring elements for attaching the ring in a passage surrounded by body tissue, in particular blood vessel tissue. An applicator for fitting the ring in the passage; in which the anchoring elements have an anchoring position in which they protrude with respect to the ring, and in which the anchoring elements comprise a memory material, such as a memory metal or memory polymer, and are designed so that they can be bent from an anchoring position counter to a spring force into a fitting position and can be frozen in this fitting position by a temperature treatment in order to bend the anchoring elements back from the fitting position by the effect of this spring force into the anchoring position when a predetermined threshold temperature is exceeded, and in which the applicator is provided distally with a carrier for carrying the ring.

Abstract: Disclosed herein is a stent for connecting adjacent tissues of the organs of a patient. The stent includes a hollow cylindrical body which is formed by weaving a superelastic shape-memory alloy wire in an overlapping manner such that rhombic openings are formed, and wing parts which are provided by expanding respective opposite ends of the hollow cylindrical body outwards and turning the opposite ends inside out on bent portions. The wing parts face each other so that the wing parts are tensed in a longitudinal direction of the cylindrical body. Thereby, the wing parts can elastically move inwards or outwards with respect to the longitudinal direction to automatically adjust a distance between the wing parts in response to the distance between the adjacent tissues of the organs or thicknesses of walls of the organs, so that the wing parts are put into close contact with the adjacent tissues.

Abstract: A vascular clip for use in end-to-side anastomoses having a handle connected to a lower ring and an upper ring. The handle includes a resilient element biasing the two rings together so that the rings are closely juxtaposed when the clip is closed. The respective facing surfaces of each of the rings may be provided with a rough surface. A graft vessel or an artificial aneurysm may be sutured to the lower ring. The graft vessel or artificial aneurysm may be autologous or heterologous material or may be made of synthetic material. The handle may fit into a clip applier that facilitates the application of the clip. The handle and the clip applier may be of different shapes depending on the various applications of the clip.

Abstract: An apparatus for delivering a closure element can include a splittable carrier tube and a splitter to split the tube. The carrier tube can have an outer surface retaining a closure element in a tubular configuration and can be split into radially-expandable flaps. A closure element has can have shape-memory body having a relaxed configuration with a planar-annular body defining a lumen with tines directed inwardly from the body. The clip can be held in a retaining configuration having a substantially asymmetrically-elongated tubular shape with a trapezoidal longitudinal cross-sectional profile and a proximal end having the tines being longitudinally directed with a first tine being more distally oriented compared to a substantially opposite second tine being more proximal, and retracting to a deploying configuration having a tubular shape with a rectangular longitudinal cross-sectional profile with the first tine being even with the second tine when being delivered.

Abstract: The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

Abstract: A device for engaging tissue may include a generally annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane. The body may be movable from a substantially planar configuration lying generally in the plane towards a transverse configuration extending out of the plane. The body may include a plurality of looped elements including alternating inner and outer curved regions. The inner curved regions may define an inner periphery of the body and the outer curved regions may define an outer periphery of the body in the planar configuration. A plurality of tines may extend from the outer curved regions. The tines may be oriented generally towards the central axis in the planar configuration and generally parallel to the central axis in the transverse configuration. The tines may extend beyond the central axis without passing through the central axis so as to collectively form a central lumen about the central axis in the planar configuration.

Abstract: Endovascular stent insertion methods are provided. In one embodiment for end-to-side anastomosis the method includes disposing an endovascular stent in a transparent sheath; inserting a guide wire through a guide needle into first and second blood vessels; sliding the endovascular stent into both the first and second blood vessels along the guide wire and the guide needle to dispose in a position between spaced first and second blood vessels; and pulling the sheath when an intermediate annular marker band of the endovascular stent seen through the transparent sheath is substantially disposed between the first blood vessel and the second blood vessel to release the endovascular stent so that the endovascular stent is adapted to expand to securely hold the facing ends of the first and second blood vessel together.

Abstract: An anchorable cannula adapted for positioning within an opening formed in tissue includes a cannula body having a proximal portion and distal portion. The proximal portion and the distal portion are linked by a circumferential ring positioned therebetween. The proximal portion includes a series of foldable arms extending upwardly from the circumferential ring and ending at a circumferential seal ring formed at a free end of the proximal portion. The distal portion includes a series of foldable arms extending downwardly from the circumferential ring and ending at a circumferential seal ring formed at a free end of the distal portion.