Abstract: A system delivering a prosthetic heart valve includes a delivery handle, a heart valve, and a valve holder. The delivery handle includes a rod, a button, and a valve holder attachment interface, where the button is configured to move between a first position and a second position along an axial length of the rod, and the valve holder attachment interface is mechanically coupled to the button and configured to move between an engaged position and a disengaged position. The heart valve includes a prosthetic valve. The valve holder is connected to a proximal end of the heart valve and includes a boss, a holder ring, and a handle attachment interface. The holder ring includes the heart valve mounted thereto and is coupled to the boss, and the handle attachment interface is formed on the boss and is configured to receive and mate with the valve holder attachment interface.

Abstract: Methods of reducing retrograde fluid flow through a valve within a body vessel are provided. The methods can include the steps of identifying a valve exhibiting an undesirable amount of retrograde fluid flow within a body vessel, such as a venous valve or a heart valve, and providing a means for reducing the retrograde fluid flow. A medical device providing a desired amount of retrograde fluid flow can be modified after permitting the medical device to remain in a body cavity for a remodeling-effective time period. The implanted medical device can be modified by subsequently reducing the amount of retrograde fluid flow permitted across the implanted prosthetic valve within the body vessel.

Abstract: A method of implanting a prosthetic valve within the heart comprises translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart. A first chamber of the inflatable structure is inflated and then, independently, a second chamber of the inflatable structure is inflated.

Abstract: The invention relates to a prosthetic valve for regulating flow through a body lumen and delivering a therapeutic agent into said lumen. In one embodiment, the prosthesis includes a frame having an exterior wall, a hollow interior space, a valve member, and at least one aperture through the exterior wall that permits a controlled amount of therapeutic agent loaded into the hollow interior into the surrounding body lumen following implantation. In another embodiment, the prosthesis includes a frame having a groove, a valve member, and therapeutic agent loaded in the groove.

Abstract: Medical device delivery systems and related kits and methods for placing multiple expandable medical devices within a body vessel are provided. A delivery system includes first and second expandable medical devices having the same or different dimensions. Placement of the first and second expandable medical devices in a body vessel can be achieved without requiring withdrawal of one or more components of the delivery system and insertion of secondary components.

Abstract: A mono cusped patch for repairing cardiac outflow tract is disclosed in the present invention, which comprises an inner patch, an external supporting patch and a leaflet. An approximate semicircular slit is provided on the inner patch. The inferior border of the leaflet is set between the inner patch and the external supporting patch along the slit. The inner patch, the inferior border of the leaflet and the external supporting patch are stitched together along the slit edge of the inner patch with sutures. The inferior border of the leaflet is fixed between the inner patch and the external supporting patch. According to this special stitching structure, the present invention also provides a valved conduit of good performance.

Abstract: Some embodiments of the present invention relate to coated biological material for the manufacture of heart valve prostheses, characterized in that the surface of the biological material is covered entirely or partially with a coating which contains or is composed of a biocompatible anorganic material, and to a process for manufacturing such a coated biological material.

Abstract: A method of implanting a prosthetic mitral valve assembly is disclosed. The prosthetic mitral valve assembly includes a stent and valve combination. The prosthetic mitral valve assembly is provided with an anchoring portion adapted to be positioned in the left atrium. In one embodiment, the anchoring portion includes at least one anchoring arm sized for placement in a pulmonary vein. The stent is radially expandable so that it can expand into position against the walls of the left atrium and accommodate a wide range of anatomies. Contact between the stent and the native tissue in the left atrium reduces paravalvular leakage and prevents migration of the stent once in place.

Abstract: Systems and methods using a heart valve and an implantable medical device, such as for event detection and optimization of cardiac output. The cardiac management system includes a heart valve, having a physiological sensor. The physiological sensor is adapted to measure at least one of an intrinsic electrical cardiac parameter, a hemodynamic parameter or the like. The system further includes an implantable electronics unit, such as a cardiac rhythm management unit, coupled to the physiological sensor of the heart valve to receive physiological information. The electronics unit is adapted to use the received physiological information to control delivery of an electrical output to the subject.

Abstract: An implantable prosthetic valve assembly having a support stent, or frame, having circumferential struts with multiple bends forming obtuse angles when the valve assembly is expanded to its functional size. The frame can be manufactured with one or more of the circumferential struts in a partially collapsed state and a flexible valve member can be mounted to the partially collapsed frame. The partially collapsed struts can be formed with multiple bends having angles selected to facilitate crimping of the frame to a profile suitable for percutaneous delivery. When the frame is expanded, the bends can expand to form obtuse angles, thereby enhancing the rigidity of the frame to better resist closing forces exerted on the valve assembly.

Abstract: A heart valve assembly includes a prosthesis for receiving a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus adjacent a sinus cavity. The prosthesis includes an annular member implantable within the biological annulus for contacting tissue surrounding the biological annulus to provide an opening through the biological annulus, a collar extending upwardly from the annular member, and a sewing cuff extending radially outwardly from the annular member and/or collar. Optionally, the annular member and/or collar may be resiliently compressible, expandable, and/or otherwise biased. A valve member, e.g., a mechanical or bioprosthetic valve may be coupled to the collar, e.g., using a drawstring, sutures, or other connectors, to secure the valve member to the gasket member.

Abstract: The present invention satisfies the long felt need for a more compact and durable valve which may be formed in situ. The present invention provides a self-deployable valve system, a method of delivery, and a method of manufacturing for the self-deployable valve system. The present invention delivers the necessary components for forming a complete valve system in situ. The collapsed subcomponents of the system lack any functional characteristics commonly associated with a valve before being expanded. However, once expanded, the system is transformed into a competent valve for use in a wide variety of applications.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Abstract: Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Abstract: A method as a workflow for imaging for a heart valve implant procedure includes positioning the patient and an articulated imaging apparatus relative to one another, inducing rapid ventricular pacing in the patient, and imaging a region of the patient's heart to obtain image date for a three-dimensional image. The three-dimensional data is used to construct a three-dimensional image of the region of the patient's heart an the three-dimensional image is displayed for use in the implanting of the replacement heart valve. Optional steps may include obtaining a real time two-dimensional image of the patient's heart and superimposing the real time two-dimensional image with the constructed three dimensional image. The replacement valve is moved into position in the patient's heart during rapid ventricular pacing and breath hold using the superimposed two-dimensional and three-dimensional image information.

Abstract: An intravascular support device includes a support or reshaper wire, a proximal anchor and a distal anchor. The support wire engages a vessel wall to change the shape of tissue adjacent the vessel in which the intravascular support is placed. The anchors and support wire are designed such that the vessel in which the support is placed remains open and can be accessed by other devices if necessary. The device provides a minimal metal surface area to blood flowing within the vessel to limit the creation of thrombosis. The anchors can be locked in place to secure the support within the vessel.

Abstract: This implant comprises an endoprosthesis having an axis which can be spontaneously deployed in a radial manner between a compressed configuration and a dilated configuration. The implant comprises at least one radial runner which comprises a separation surface which extends radially with respect to an outer surface of the endoprosthesis and a member which can be deployed away from the axis. The runner is arranged so as to delimit a confinement housing which extends between the separation surface and the outer surface and a radial spacer which is defined by the separation surface and the deployable member. When the implant is retained in a state of radial compression, the maximum radial width of the housing is less than the maximum radial width of the spacer which is not equal to zero.

Abstract: In an embodiment, a device for loading a prosthesis onto a delivery system comprises a cap and a reducing member. The cap has a piston member that seats a prosthesis. The piston member has at least one side wall configured to contact a portion of the side of the prosthesis seated therein. The reducing member has a conical wall, a first open end, and a second open end. The first open end is configured to receive the piston member. The reducing member reduces an external dimension of at least a portion of the prosthesis seated in the piston member as the prosthesis is moved along an inner surface of the conical wall.

Abstract: A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.

Abstract: An intra-annular mounting frame for an aortic valve having native aortic cusps is provided which includes a frame body with native leaflet reorienting curvatures and interconnecting points; the curvatures shaped to be received inside the valve below the native aortic cusps and to reorient the native aortic cusps within the aortic valve, where each of the curvatures extends concavely upward from a reference latitudinal plane tangential to each curvature's base.

Abstract: A polymer is provided according to structure (I) wherein Y is a thiol-reactive group selected from one or more of the following moieties and Z is an ionogenic group selected from one or more of the following moieties. The surface of a polymeric substrate is modified by contacting the surface with a polymer according to structure II or structure III and exposing the surface to ultraviolet light.

Abstract: A heart valve annulus sizer is provided for measuring a valve to be fitted with an annuloplasty ring. The sizer may include a body having a peripheral portion defining an opening, at least one rib disposed within the opening and dividing the opening into at least a first opening and a second opening, and an anchor disposed on and projecting from the body. The sizer may include a length of suture connected to the body. The anchor may include an aperture adapted to receive the length of suture. A method of using the sizer is provided that includes grasping the sizer with an instrument and positioning the sizer adjacent to a valve into a position suitable to allow for measurement of the valve.

Abstract: A valve loading system is provided that uses a valve loader to transfer a valve or other medical device from a storage cartridge into a deployment catheter. The valve or other medical device can be implanted or positioned within a patient using the catheter after the valve or other medical device has been compressed and loaded into the catheter using the valve loader. The process then can be repeated by using the valve loading system to load or introduce another valve or other medical device into the catheter.

Abstract: Apparatus is provided that includes a valve prosthesis for attachment to a native valve complex of a subject. The prosthesis is configured to assume a compressed delivery state and an uncompressed implantation state. The prosthesis includes a support frame, which is shaped so as to define an upstream inlet having upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state. The prosthesis further includes a flexible prosthetic heart valve component, coupled to the support frame. Other embodiments are also described.

Abstract: A medical device which defines a lumen for flowing a bodily fluid from an upstream end of the device to a downstream end thereof is disclosed. The device has a luminal wall (14) that extends between the upstream and downstream ends and defines the lumen within which the fluid flows. The wall exhibits a succession of protuberances spaced from each other along the length of the device. Each protuberance has a flank facing upstream (54) and a flank facing downstream (64), the flank facing upstream extending into the fluid flow so that a radially outermost part of the flow of fluid from the upstream to the downstream end of the device impinges on the upstream flank and is thereby caused to reverse its flow, and flow upstream from the upstream flank to the downstream flank of the next adjacent protuberance upstream, creating micro-vortices between two adjacent protuberances.

Abstract: The device relates to clinical cardiology and cardiovascular surgery.

Abstract: A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.

Abstract: An instrument for deploying a cardiac valve prosthesis, including a plurality of radially expandable portions, at an implantation site, includes a plurality of deployment elements each independently operable to obtain the radial expansion of a radially expandable portion of the valve prosthesis. Additionally, the instrument is adapted to provide a de-aired, fluid-filled, or gas filled environment in order to minimize and/or prevent air embolism during the implantation procedure. The fluid can contain a drug. A method for deploying the cardiac valve prosthesis includes advancing the instrument to an implant site and independently actuating the radially expandable portions.

Abstract: A device includes a support defining at least one opening for retaining an implant situated in the vicinity of the distal end thereof, and at least one threadlike link for retaining the implant. The link includes a control portion engaged in the support and a tightening loop of the implant which projects outside the support through the retention opening. A component is provided for placing each tightening loop around the implant. The placement component includes a rigid member and at least one flexible cord integral with the member and engaged releasably around the tightening loop.

Abstract: A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Abstract: An inflatable implant is disclosed. The inflatable implant comprises at least one inflation channel for forming an inflatable structure of the inflatable implant; and an inflation media disposed within the at least one inflation channel, wherein the inflation media comprises a mixture of an epoxy resin and a hardener, the mixture is configured to gel at about 37° C. in less than about 2.5 hours after mixing to form a gelled mixture.

Abstract: This invention is directed toward surface treatment of a device. The surface treatment comprises the attachment of interactive segmented block copolymers to the surface of the substrate by means of interactive functionalities of the segmented block copolymer reacting with complementary surface functionalities in monomeric units along the polymer substrate. The present invention is also directed to a surface modified medical device, examples of which include contact lenses, intraocular lenses, vascular stents, phakic intraocular lenses, aphakic intraocular lenses, corneal implants, catheters, implants, and the like, comprising a surface made by such a method.

Abstract: The perivascular leak repair system, and method of using the same, of the present invention provides a sealant reservoir 102 with a repair catheter 104 operably attached; a flow control device 106 disposed between the sealant reservoir 102 and the repair catheter 104, and the flow control device 106 responsive to a flow control signal 108; a heart phase detector 114 generating a diastole phase signal 112; an injection switch 122 generating a injection signal 120; and a flow controller 110 responsive to the diastole phase signal 112 and the injection signal 120, and generating the flow control signal 108. A method of sealing a perivascular leak comprises identifying the perivascular leak 140; inserting a repair catheter to the perivascular leak 142; injecting sealant at the perivascular leak 144; and removing the repair catheter 146. The sealant can be injected when the heart is in diastole to sweep the sealant into the perivascular leak.

Abstract: A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient's ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent (20).

Abstract: An implantable endoluminal prosthesis for replacing a damaged aortic valve is provided. In one embodiment, the prosthesis includes a balloon-expandable stent, a tubular conduit that extends into the ascending aorta, and a self-expanding stent. The tubular conduit extends across the balloon-expandable stent. The tubular conduit includes an artificial valve. The self-expanding stent extends across the tubular conduit into the ascending aorta. The balloon-expandable stent, the tubular conduit, and the self-expanding stent are coupled to provide unidirectional flow of fluid into the aorta and further into the coronary arteries. Also provided is a method for implanting the endoluminal prosthesis.

Abstract: A method is provided including coupling a tissue-engaging element to a first portion of cardiac tissue of a heart of a patient and advancing toward the tissue-engaging element an adjustment mechanism along at least one guide member that is removably coupled to the tissue-engaging element. The adjustment mechanism engages a first portion of a first flexible longitudinal member. A second portion of the first flexible longitudinal member is coupled to a second portion of cardiac tissue. Following the coupling of the second portion of the first flexible longitudinal member to the second portion of cardiac tissue, the adjustment mechanism is slid further along the guide member and coupled to the tissue-engaging element. Using the adjustment mechanism, a length of the first flexible longitudinal member is adjusted between the first and second portions of cardiac tissue. Other applications are also described.

Abstract: Apparatus is provided, including an artificial-chordeae-tendineae-adjustment mechanism and at least one primary artificial chordea tendinea coupled at a distal portion thereof to the artificial-chordeae-tendineae-adjustment mechanism. A degree of tension of the at least one primary artificial chordea tendinea is adjustable by the artificial-chordeae-tendineae-adjustment mechanism. One or more loops are coupled at a proximal portion of the at least one primary artificial chordea tendinea. The one or more loops are configured to facilitate suturing of the one or more loops to respective portions of a leaflet of an atrioventricular valve of a patient. Other applications are also described.

Abstract: The invention relates to a self-expandable medical instrument (100) for treating defects in a patient's heart, in particular for the transvascular implantation of a prosthetic heart valve (30), wherein the medical instrument (100) is introducible into the body of a patient in a minimally-invasive procedure using a catheter system (40) and comprises a stent (1) made of a flexible mesh (2) of thin wires or filaments (2?). In order to realize a positioning of medical instrument (100) in the patient's heart which is as precise as possible and to securely anchor same there, it is provided for the stent (1) composed of the flexible mesh (2) to exhibit in the expanded state of the medical instrument (100) a distal retention area (10) with a laterally-inverted beaded portion (12) which is engageable in at least one pocket (51) of the patient's defective heart valve (50), a proximal retention area (20), and a center area (15) positioned between the distal and the proximal retention area (10, 20).

Abstract: Devices for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combination thereof.

Abstract: The present invention is an improved apparatus for holding and maneuvering a valve during preparation and attachment to patient. The present invention is particularly useful for increased visibility of the prosthetic valve and the sewing ring to prevent suture entanglement. The present invention is used most effectively with mitral valves having commissure posts on the outflow side of the valve structure but may be used with other valve configurations. The present invention spaces the handle attachment from the valve for improved visibility of the sewing ring and the outlet end of the valve during attachment. The present invention is adapted to safely bend the commissure posts inward at the tips while preventing crashing the commissure posts into each other causing damage.

Abstract: A heart valve prosthesis disclosed in two- and three-leaflet versions includes a ring-shaped body, leaflets, and leaflet turn stops. For the two-leaflet version, the stops represent two pairs of prominences located on a body end surface facing the blood down-flow. The first pair has internal surfaces, at least partially made flat, adapted to interact with flat sections of the leaflets to restrict the return blood flow in the closed position. The first pair is equipped with at least two rests interacting with a leaflet top surface facing the blood down-flow in its open position determining a leaflet turning angle. Each prominence of the second pair is located opposite a portion of the lateral surface of the corresponding leaflet most distant from a leaflet central surface and can interact with its internal surface with that part of the lateral surface during opening of the heart valve prosthesis.

Abstract: An implantable annuloplasty suture guide is intended to lie against at least a portion of an annulus surrounding a human heart. The implantable annuloplasty suture guide is made of an elongated ribbon of braided, heat setable material. The braided, heat-setable material is heat-set in a curved lengthwise configuration corresponding to at least a portion of the annulus of the human heart valve. A method of making an implantable annuloplasty suture guide configured to lie against at least a portion of an annulus defined by tissue surrounding a human heart. The method includes the steps of providing an elongate biocompatible ribbon comprising a braided, heat setable material. A fixture is provided, with the fixture comprising a heat conducting material defining an elongate cavity having a curved length-wise configuration corresponding to at least a portion of the annulus defined by the tissue surrounding the human heart.

Abstract: Methods and apparatus for use in repairing an atrioventricular valve in a patient are provided. The methods comprise accessing the patient's atrioventricular valve percutaneously, securing a fastening mechanism to a valve leaflet, and coupling the valve leaflet, while the patient's heart remains beating, to at least one of a ventricular wall adjacent the atrioventricular valve, a papillary muscle, at least one valve chordae, and a valve annulus to facilitate reducing leakage through the valve.

Abstract: Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

Abstract: Implants or systems of implants and methods apply an upward and inward force producing a minor axis force projection vector within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

Abstract: In one aspect, the present invention provides implantable or insertable medical devices, which contain at least one polymeric region. The polymeric region contains at least one fluorocarbon-containing block copolymer, which, in turn, contains (a) at least one fluorocarbon-containing, low glass transition temperature (low Tg) copolymer chain and (b) at least one glass transition temperature (high Tg) polymer chain.

Abstract: A cardiovascular prosthetic valve comprises an inflatable body that has at least a first inflatable chamber and a second inflatable chamber that is not in fluid communication with the first inflatable chamber. The inflatable body is configured to form, at least in part, a generally annular ring. A valve is coupled to the inflatable body. The valve is configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction. A first inflation port is in communication with the first inflatable chamber. A second inflation port in communication with the second inflatable chamber.

Abstract: A vascular prosthesis is constructed from a structure having interconnected, helically oriented channel-porosity to allow oriented ingrowth of connective tissue into a wall of the prosthesis. The prosthesis can have a small internal diameter of 6 mm or less. Several different methods can be used to produce the prosthesis, including a fiber winding and extraction technique, a melt extrusion technique, and a particle and fiber extraction technique using either a layered method or a continuous method. Furthermore, mechanical properties of prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: A replacement heart valve device usable in a medical procedure in relation in heart valve replacement of a patient. In one embodiment, the replacement heart valve device includes a heart valve holder or conduit holder formed in the form of a cylindrical tube having a longitudinal cut substantially extending from one end to the other end of the cylindrical tube, and a conduit formed with a tubular segment of an elastic material. The conduit is mountable onto the heart valve holder or conduit holder or self-expanding stent. In one embodiment, at least a portion of the conduit is formed with a single layer of the elastic material. In another embodiment, at least a portion of the conduit is formed with two layers of the elastic material.

Abstract: It has been discovered that improved yields of engineered tissue following implantation, and engineered tissue having enhanced mechanical strength and flexibility or pliability, can be obtained by implantation, preferably subcutaneously, of a fibrous polymeric matrix for a period of time sufficient to obtain ingrowth of fibrous tissue and/or blood vessels, which is the removed for subsequent implantation at the site where the implant is desired. The matrix is optionally seeded prior to the first implantation, after ingrowth of the fibrous tissue, or at the time of reimplantation. The time required for fibrous ingrowth typically ranges from days to weeks. The method is particularly useful in making valves and tubular structures, especially heart valves and blood vessels.