Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: Devices, systems, and methods for treating vascular defects are disclosed herein. One aspect of the present technology, for example, includes an occlusive device comprising an expandable mesh including an outer mesh and an inner mesh disposed within the outer mesh when the mesh is in an expanded, unconstrained state. The mesh may include a connection portion positioned at or within an inner cavity of the inner mesh and configured to be detachably coupled to a delivery member. The inner cavity may be configured to receive a distal portion of an elongated shaft and contain the distal portion while one or more coils is delivered through the elongated shaft into the inner cavity.

Abstract: An implant can be implanted in an aneurysm to cause thrombogenesis within the aneurysm's sac. The implant can include a braid that can extend across the aneurysm neck and anchor to aneurysm's walls at least in the proximal portion of the aneurysm sac. The implant can further include a dome feature configured to press into aneurysm walls near the aneurysm's dome and facilitate securement of the braid across the aneurysm's neck. The braid at the aneurysm's neck and the dome feature can be joined or constricted at a junction, for instance with a radiopaque band. The dome feature can include a braid, embolic coil, and/or wire frame. The braid can be inverted based on a heat-set predetermined shape, where several predetermined shapes are suitable.

Abstract: Described herein is a medical device for treating a target site, the medical device including, a proximal end including a disc and a distal end including a lobe. The disc and the lobe are connected by a connecting member. The lobe includes a proximal portion defining a proximal surface of the lobe, a distal portion defining a distal surface of the lobe, and a middle portion connecting and extending between the proximal portion and the distal portion. A first transition between the proximal portion and the middle portion is curved, and a second transition between the middle portion and the distal portion is curved. The medical device also includes a plurality of stabilizing wires coupled to the lobe at a radially outer surface of the middle portion, each stabilizing wire including a hook portion extending radially outward from the at least one lobe.

Abstract: A delivery sheath is provided that that can be used to deliver a therapeutic device to the heart without dislodging the device when the delivery sheath is removed. The delivery sheath comprises a tubular body having a proximal end, a distal end, and a lumen. The therapeutic device is delivered through the lumen. A slit is provided along the length of the tubular body creating two opposing edges along the length of the tubular body. A guide wire engages along an entire length of the slit and closing the two opposing edges to form the lumen. The slit is opened from the distal end of the tubular body toward the proximal end of the tubular body by pulling on the guide wire at the proximal end, whereby the lumen expands and separates from the therapeutic device facilitating the extraction of the delivery sheath without disruption to the implanted device.

Abstract: A clot removal device for removing clot from a body vessel comprising an expandable structure and an elongate member. The elongate member can have a proximal end and a distal end, the elongate member being connected to the expandable structure at its distal end. The expandable structure can have a constrained delivery configuration, an expanded clot engaging deployed configuration, and an at least partially constrained clot pinching configuration. At least a portion of the expandable structure can be configured to engage clot in the expanded deployed configuration and to pinch clot on movement from the deployed configuration to the clot pinching configuration.

Abstract: A device includes an electrically conductive or electrically semiconductive material and a biocompatible porous scaffold around the electrically conductive or electrically semiconductive material. The biocompatible porous scaffold includes a biocompatible polymer and pores configured to capture metastatic cells.

Abstract: The stent has an expansive force 0.05 N/mm or less per unit length when it has a diameter equal to the lower limit diameter of the target blood vessel and is measured under the following conditions. A radial force testing system manufactured by Blockwise Engineering LLC is used as a tester. The test conditions include a temperature of 37° C.±2° C. in the chamber of the tester; a stent diameter of 0.5 mm for start of test, and a rate of increase of diameter of 0.5 mm/s in the tester. The test method includes radially compressing the stent disposed in the chamber; recording an expansive force while gradually increasing the diameter of the chamber at the rate of increase of diameter; and dividing the expansive force by the effective length of the stent to calculate an expansive force per unit length.

Abstract: A system for delivering an implant device to a vascular site in a patient a delivery pusher apparatus, an implant device detachably connected to the delivery pusher apparatus by a tether having a distal end connected to a proximal end of the implant device, wherein the tether is substantially non-tensioned when connecting the implant device to the delivery pusher, and an electrical heating element configured coaxially around at least a portion of the tether, wherein heat generated by the heating element severs the tether at a point near the proximal end of the implant device.

Abstract: This covered stent 100, which is released from a sheath 200 and placed in a lumen in a living body, is provided with: a tubular skeleton portion 11 which is stretchable in the axial direction and is expandable in the radial direction substantially perpendicular to the axial direction; and a stretch restriction portion 2 for restricting stretching of the skeleton portion in the axial direction. The stretch restriction portion is formed from a material different from that of the skeleton portion and restricts stretching of the skeleton portion in the axial direction when the skeleton portion is contracted in the radial direction while being stored in the sheath.

Abstract: Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology.

Abstract: A balloon catheter-stent device includes a balloon catheter has a catheter tube and a radially expandable balloon. A stent surrounds the balloon. The stent can be radially expanded in its radial extent by the balloon. The stent includes at least one folding protrusion, which unfolds with radial expansion and axial shortening of the stent to form an outer stent protrusion.

Abstract: A clot removal device including an elongated member including a distal end; and an expandable frame including a proximal end, and one or more frame members including one or more pinching cells operable to be slidably and rotatably placed thereon, each of the pinching cells including a collapsed state within a microcatheter and an expanded state distal of the microcatheter configured to tweeze at least a portion of a clot.

Abstract: There is described an arteriovenous fistula stent, having a tubular body comprising a series of sinusoidal shaped struts along the length of the tubular body. A plurality of curvilinear connectors extend between and are attached to adjacent struts wherein a first end of a connector is attached to a distal face of a proximal strut apex and a second end of a connector is attached to a proximal face of a distal strut apex. A pair of unconnected strut apexes are between pairs of connected apexes. When the tubular body is in a stowed configuration a proximal aperture and a distal aperture are circular and when the tubular body is in a deployed configuration the distal aperture is oblong or ovoid. There is also described a method for inserting a stent for use in creation of an arteriovenous fistula by identifying a candidate artery and a candidate vein and dissecting the candidate vein. Next, inserting a stent into the vein and creating a breach in the candidate artery at a desired angle and location.

Abstract: An eustachian tube (ET) drug eluting stent includes a plurality of longitudinal spars with spring-like elements between each of the plurality of longitudinal spars, creating smooth arcs between each of the plurality of longitudinal spars while minimizing impediment of mucociliary flow. The combination of the plurality of longitudinal spars with spring-like elements are configured to enter into the ET uncompressed.

Abstract: A self-sealing tubular graft is provided for implantation within a patient's body that includes an elongate tubular body including first and second self-sealing cannulation regions and a loop region extending between the first and second cannulation regions. The loop region includes one or more reinforcement members attached to a first length of the loop region and extending at least partially around a circumference of the tubular body. For example, the reinforcement members may include one or more sinusoidal or zigzag members extending along the first length with alternating peaks and valleys extending at least partially around a circumference of the tubular body. Self-sealing patches are also provided that include one or more reinforcement members embedded within base material.

Abstract: Devices and methods for securing a cover of a retrieval device while the retrieval device is resheathed to a more proximal position within a delivery sheath are disclosed herein. A retrieval device may include, for example, a securing element configured to grip the cover when the retrieval device is pulled proximally, to thereby secure the cover. A method of positioning the retrieval device may include, for example: (a) advancing the retrieval device distally through a delivery sheath to a partially deployed state while the securing element is in a first state, and (b) retracting the clot retrieval proximally from the partially deployed state while the securing element is in a second state that grips the cover to secure the cover.

Abstract: A radially expandable, tubular stent, includes a first section having a first crush resistance force and a second section have a second crush resistance force, wherein the first crush resistance force is less than the second crush resistance force. The first section is connected to the second section to form a tube, connection of the first and second sections extending in an axial direction of the tube.

Abstract: A method and device include attaching a tether portion of a sleeve to a distal end of a catheter, placing the distal end of the catheter into a selected position within a vessel, moving a stent through a lumen of the catheter, retentively engaging a first end of the stent with a distal end of the sleeve, and detaching the sleeve about the tether portion such that the sleeve covers at least a portion of the stent at the selected position within the vessel.

Abstract: A stent having a line-shaped body that extends helically in a circumferential direction while reciprocating in an axial direction by continuously alternating straight parts and curved parts, wherein the plurality of straight parts in the line-shaped body have a substantially constant thickness throughout the entire stent, and a certain number of the plurality of curved parts in the line-shaped body have different thicknesses.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A delivery system and method for implanting a stent graft includes a flexible sheath that defines openings distributed longitudinally and wherein substantial alignment of the openings along a longitudinal axis of a guidewire catheter radially constrict the flexible sheath. The flexible sheath includes at least one fenestration. A ligature extends through the openings of the flexible sheath and causes the openings to be substantially aligned, thereby constraining the flexible sheath. The ligature is proximally retractable from the openings to thereby release the flexible sheath from a radially constricted configuration.

Abstract: A suction stent for introduction into a hollow organ of the human or animal body, preferably into the gastrointestinal tract, in particular the intestine, includes a tubular hollow body which is open in the longitudinal direction and made of biocompatible material. The tubular hollow body has 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, a method is provided for sealing a leakage, especially an anastomosis, of the hollow organ.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: Described are methods, systems, devices for facilitation of intraluminal medical procedures within the neurovasculature. A catheter advancement device includes a flexible elongate body having a proximal portion coupled to a proximal end region of the flexible elongate body and extending proximally to a proximal-most end of the catheter advancement element. A hardness of the flexible elongate body transitions proximally towards increasingly harder materials up to the proximal portion forming a first plurality of material transitions. At least a portion of the flexible elongate body is formed of a plurality of layers including a reinforcement layer. An outer diameter of the flexible elongate body is sized to be positioned coaxially within a lumen of a catheter such that a distal tip portion of the flexible elongate body extends distally beyond a distal end of the catheter to aid in delivery of the catheter to an intracranial vessel.

Abstract: A multi-spiral, self-expanding stent is constructed from superposed individual spiral strands. Each spiral strand comprises a terminal bend that separates the strand into a first portion and a second portion. Particularly, the first portion of each strand bends in a first spiral direction to the terminal bend, and the second portion bends in the opposite direction after the terminal bend. Advantageously, the disclosed stent is able to change its shape, diameter, and length to accommodate the corresponding shape, diameter, and length of patient's diseased vessel.

Abstract: The invention is directed to an expandable stent for implantation in a body lumen, such as an artery, and a method for making it from a single length of tubing. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common axis and interconnected by one or more links. A Y-shaped member comprised of a link and a U-shaped member has relief dimples formed in the curved portion of a valley to reduce localized stress and thereby reduce fatigue failure that can lead to link structure failure.

Abstract: An electrosurgical instrument, in particular for argon plasma coagulation, includes a handpiece 10, an electrode (11) connected to the handpiece (10), a shaft (12) which surrounds the electrode (11) and is held in the handpiece (10), and an operating mechanism (13), which comprises at least one rotary knob (14) arranged on the handpiece (10). The shaft (12) is axially movable relative to the electrode (11) and a shear force can be applied to it by operating the rotary knob (14). The handpiece (10) has a brake device which exerts a braking force on the shaft (12), and the operating mechanism (13) forms a transmission gear (15) which is connected to the shaft (12) for transferring the shear force.

Abstract: Medical devices and method for making and using the same are disclosed. An example medical device may include implantable medical device for use along the biliary and/or pancreatic tract. The implantable medical device may include a tubular member having a first end configured to be disposed within the duodenum of a patient and a second end configured to be disposed adjacent to a pancreatic duct and/or bile duct. The tubular member may have a body including one or more wire filaments that are woven together. The tubular member may also have an outer surface with a longitudinal channel formed therein.

Abstract: A stent is formed from an at least partially cylindrical non-bioresorbable framework with a longitudinal zone of the stent that extends from the proximal end of the framework to the distal end and is defined by opposing longitudinal edges. A plurality of bioresorbable struts are secured to opposing longitudinal edges of the longitudinal zone. The bioresorbable struts hold the opposing longitudinal edges a first distance apart at an expanded deployed diameter to apposition the framework against a wall defining the vessel. After the stent is endothelialized, degradation of the bioresorbable struts causes the stent to contract to a reduced deployed diameter so that the opposing longitudinal edges are a second distance apart that is less than the first distance.

Abstract: A stent-graft assembly is provided for a variety of medical treatments. The stent-graft assembly includes a stent disposed to and attached between an inner layer of graft material and an outer layer of graft material. One of both of the graft layers includes one or more of a depression, dimple or detent that increases the localized surface area of the graft in one or more portions of the stent otherwise susceptible to graft stretching in the absence of the depression, dimple or detent. There is also described a method of forming dimples in selective locations on one or port graft layers in one or more locations relative to a portion of the stent where a portion of the graft may be susceptible to stretching or tearing during crimping or loading operations.

Abstract: To provide simple yet accurate stent graft fenestration, a patient-specific fenestration template is used as a guide for graft fenestration. To generate the fenestration template, a patient's medical imaging data such as CT scan data may be used to generate a 3-D digital model of an aorta lumen of the patient. The aorta lumen may encompass one or more branch vessels, which may be indicated on the 3-D digital model. Based on the 3-D digital model or a segment thereof, the fenestration template may be generated, for example, using 3-D printing technology. The fenestration template may include one or more holes or openings that correspond to the one or more branch vessels. To fenestrate a stent graft, the fenestration template is coupled to the stent graft so that the holes or openings on the fenestration template indicate the fenestration locations.

Abstract: A stent that includes a plurality of quill filaments. Each quill filament includes filament material, a surface, and a plurality of quills. Each quill has a tip, a body, and a base where the body extends from the base to the tip. The quill filaments can be interwoven to form the stent or the quill filaments can be engaged to the framework of a stent.

Abstract: A stent includes expandable rings formed from a plurality of interconnected struts. A plurality of bridges couple adjacent rings together. The bridges are connected to adjacent rings at first and second connection points, and a first brace element is disposed therebetween. The first connection point is circumferentially offset relative to the second connection point so that the bridge is transverse to the longitudinal axis of the stent. The first brace element of one bridge engages an adjacent bridge or a brace element of the adjacent bridge when the corresponding adjacent rings are in the contracted configuration thereby providing additional support and rigidity to the stent to lessen buckling of the stent during loading onto a delivery catheter or during deployment therefrom.

Abstract: A method of braiding a stent includes braiding a number of elongate filaments around a mandrel using tensioned braiding carriers without spooling the filaments to the tensioned braiding carriers to form a braided stent having atraumatic ends.

Abstract: The present disclosure provides stents, particularly self-expanding stents, useful for the GI tract, and more particularly, useful for treating esophageal strictures. The stents provided herein include a medial region and proximal and distal cuffs having external diameters greater than the medial region diameter when the stent is in the deployed state. The medial region comprises an open weave wire construction. An elastomeric coating circumscribes the medial region, while the may be an extension of the wire construction or separate elements. Preferably, the cuffs have a textured surface for contact with the esophageal wall tissue to resist stent migration. The elastomer coated medial region provides a barrier to tissue ingrowth, and has an enhanced radial restoring force to maintain an open passageway in a body lumen. Optionally, the stent includes an exterior sheath with a surface pattern, to which the stent couples.

Abstract: Devices for removing clot material from a blood vessel lumen and associated systems and methods are disclosed herein. A clot retrieving device may include, for example, an elongated shaft, a capture structure having a proximal portion and a distal portion, and a cover having a first portion coupled to the elongated shaft and a second portion extending from the first portion. The cover may have an inverted configuration in which the capture structure is at least partially ensheathed within the first portion of the cover and the second portion of the cover extends distally from the first portion. In the inverted configuration, the second portion may have (a) a first region distal to a distal terminus of the capture structure, the first region tapering radially inwardly in a distal direction, and (b) a second region extending distally and radially outwardly from the first region.

Abstract: The present teachings provide a device and methods of making and using thereof. Specifically, one aspect of the present teachings provides a self-expandable device with a braided structure comprising a shunt, a distal retention flange, and a proximal retention flange. Upon the device being deployed at a treatment location, the distal retention flange or the proximal retention flange transitions to have a diameter that is greater than the diameter of the shunt portion. And the shunt portion has a braid angle ?. Another aspect of the present teachings provide that the ratio of flange/shunt diameter equals or greater than 1/sin ?. Yet another aspect of the present teachings provides an axial constraining mechanism to reinforce the shunt portion.

Abstract: An intravascular stent (100, 200, 300) comprises a framework with openings and at least one radiopaque structure (103, 201, 301). Each radiopaque structure (103, 201, 301) comprises fixed bodies and radiopaque markers (105, 208, 307) filled in the fixed bodies. The fixed bodies are connected with the framework, and are at least partially disposed in the openings. The envelope enclosed area of all the radiopaque markers (105, 208, 307) in each radiopaque structure (103, 201, 301) is less than or equal to 2 mm2, and a sum of effective areas of all the radiopaque markers (105, 208, 307) in each radiopaque structure (103, 201, 301) is greater than or equal to 0.15 mm2, and a ratio of said sum of effective areas to said envelope enclosed area is greater than or equal to 1:5. The radiopaque structure (103, 201, 301) has a desirable visibility, and does not substantially affect the crimped diameter of the intravascular stent (100, 200, 300).

Abstract: A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a left heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.

Abstract: A prosthesis can include a collapsible, reexpandable frame having first, second, and third sets of struts that define first and second rows of expandable cells. In some embodiments, the struts of the first, second, and third set of struts can be tapered. In some embodiments, the frame can include an intermediate section and an inflow section that is proximal to the intermediate section. The inflow section can include a concave saddle portion that is adjacent the intermediate section, and an outwardly flared portion.

Abstract: A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient's body and expanded to secure a heart valve prosthesis in the patient's aorta. In an embodiment, the endoprosthesis has a plurality of positioning arches configured to be positioned with respect to a patient's aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a first collapsed mode during the process of introducing it into the patient's body and a second expanded mode when it is implanted.

Abstract: This invention discloses method of manufacture of balloon expandable stent made from bioabsorbable polymer with thin struts (strut thickness 130 ?m or less, preferably 100-110 ?m) with high fatigue and radial strength. The invention further discloses balloon expandable stent made from bioabsorbable polymer with thin struts (strut thickness 130 ?m or less, preferably 100-110 ?m) with high fatigue and radial strength.

Abstract: The present invention relates to a method for manufacturing a stent, the method using a jig in which detachable protruding pins are installed at all respective location points at which circumference division lines and length division lines intersect each other, the method forming cells through intersection of wire by setting any one of the location points as a start point and repeatedly bending and moving the wire from the start point upward and downward to pass over the protruding pins located in diagonal directions, wherein a first stent woven such that intersection portions formed through the intersection of a wire are spaced apart from each other in a diagonal direction and arranged one for each length division line and a second stent woven to maintain the structural stability of the first stent and to prevent the first stent from being twisted can be provided as a single stent.

Abstract: A device includes a first end portion, a second end portion, an intermediate portion between the first end portion and the second end portion, and a graft material coupled to at least the intermediate portion. The first end portion has a first end diameter. The second end portion has a second end diameter larger than the first end diameter. The intermediate portion tapers between the first end portion and the second end portion. A method of diverting fluid flow from a first passage to a second passage comprising deploying the device in a third passage between the first passage and the second passage, expanding the first end portion against sidewalls of the first passage, and expanding the second end portion against sidewalls of the second passage.

Abstract: A cannula cut spiral flow inducing stent includes a plurality of spiral inducing flow diverters that each include a piece of sheet metal with a helically shaped flow surface. A proximal stent region, which includes a plurality of first struts, is joined to a proximal end of each of the spiral inducing flow diverters. A distal stent region, which includes a plurality of second struts, is joined to a distal end of each of the spiral inducing flow diverters. All of the first struts and all of the second struts share a cannula thickness, but the shaped pieces of sheet metal may have a lesser thickness.

Abstract: A perfusion device and a delivery system for repair of a damaged portion of a body vessel. Perfusion device can include a tubular body that is self-expandable, having a proximal portion, a distal portion, and an intermediate portion. One or more series of barbs can be disposed circumferentially along the intermediate portion. Barbs are capable of penetrating into the tunica intima and tunica media of said vessel wall upon insertion of said device into said body vessel, and not into said tunica adventitia. A graft can be associated with the tubular body. Graft has a proximal end and a distal end, and preferably extends entirely along a luminal wall of the tubular body. Graft may also extend along an exterior surface of the tubular body at the proximal and distal portions. Delivery devices for the perfusion implant and methods of delivering the perfusion implant are also provided.

Abstract: A stent includes a high radial force segment and a highly flexible segment, where the diameters of the high radial force segment and the highly flexible segment are substantially the same. The stent may further be placed with an additional stent segment, where the additional stent segment has a radial force similar to the radial force of the highly flexible force segment.

Abstract: A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

Abstract: A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.