Abstract: A prosthetic valve assembly can include a radially expandable stent. The stent can includea first expandable annular portion that is configured, in an expanded state, to bear against a wall of a native body lumen, a second expandable annular portion that is configured, in an expanded state, to bear against a wall of a native body lumen. The stent can also include a plurality of rods extending between the first annular portion and the second annular portion. The prosthetic valve assembly can further include an implantable prosthetic valve mounted to the stent such that the valve is between the first annular portion and the second annular portion. The prosthetic valve assembly is configured to be delivered by catheterization.

Abstract: A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

Abstract: Prosthetic valves, methods of making medical devices, and methods of treatment are provided. The prosthetic valves of the invention have a valve portion moveable between first and second positions, and a spacing member that has a thickness and protects a portion of the valve portion from contact with a wall of a vessel in which the prosthetic valve is implanted, and/or another structural component of the prosthetic valve, such as a support frame.

Abstract: An endoluminal support structure includes strut members interconnected by pivot joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

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: Implantable prosthetic valves comprising support frames are provided. The support frames may include a plurality of symmetrically arrayed interconnected U-shaped member structures. Preferred support frames are tubular structures enclosing a longitudinal axis and including a plurality of U-shaped member structures facing a distal or a proximal end of the support frame. Each U-shaped member structure may be connected to a single longitudinally adjacent U-shaped member facing in an opposite longitudinal direction, as well as two laterally adjacent U-shaped members.

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: A stent (10) for transluminal implantation comprises a first, second and third stent section (11, 12, 13) for splinting and/or keeping open a hollow organ which are connected to each other via elastic tubular sections (14, 15). The stent (10) combines at least three different stent designs in one stent and can therefore be adjusted to the motion behavior of a hollow organ in an improved fashion (FIG. 1).

Abstract: Several unique intracardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intracardiac pressure vents presented allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms. In an aspect of the invention, the interatrial device comprises portions that are more flexible or less flexible than another portion of the device.

Abstract: A method of remodeling a stented device and an adjacent a valve region of a patient, including the steps of implanting a stented device into a native valve region of a patient, providing a first remodeling ring on a portion of a delivery system, advancing the remodeling ring into an interior area of the implanted stented device with the delivery system, radially expanding the remodeling ring until it modifies at least one of an aspect of a shape of the interior area of the implanted stented device and an aspect of a shape of the valve region in which it is positioned, and removing the delivery system from the patient.

Abstract: A prosthesis comprises a tubular member that defines an inner lumen and has an inner surface and an outer surface, an outer member secured to the tubular member and covering at least a portion of the tubular member outer surface and forming an outer chamber therewith, and at least one valve in the tubular member to regulate or control fluid flow between the tubular member lumen and the chamber.

Abstract: Medical devices for implantation within a body vessel can include a remodelable material, such as an extracellular matrix material, positioned within a lumen defined by an outer covering material. The covering material is preferably substantially non-remodelable, and can be supported by a radially expandable frame. The medical device can also include a valve means positioned within the covering material. The valve means can include one or more valve leaflets formed from the remodelable material, and a separate valve support frame. One or more therapeutic agents can be associated with the remodelable material or the covering material.

Abstract: A self-expanding or otherwise expandable artificial valve prostheses for deployment within a body passageway, such as a vessel or duct of a patient. The valve prostheses include a support structure having an outer frame, a supporting member and a valve leaflet. The portion of the valve leaflet is supported by the supporting member and is positioned away from the wall of the body passageway when the device is deployed within the body passageway.

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: An esophageal valve comprising a polymeric valve body having an outer support region, at least three valve leaflets, and a main body region extending between the support region and the valve leaflets. The valve has a normally closed configuration in which the valve is closed, an antegrade open configuration in which the valve leaflets are opened in response to an antegrade force to allow flow through the valve and a retrograde open configuration in response to a retrograde force which is substantially larger than the antegrade force.

Abstract: A valve with a frame and valve leaflets that provide a sinus pocket. The valve provides for unidirectional flow of a liquid through the valve.

Abstract: An endoluminal support structure includes strut members interconnected by pivot joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A prosthetic valve for regulating fluid flow through a body vessel is provided. The valve includes an expandable support frame and a valve leaflet, and includes at least one opening that permits a controlled amount of retrograde flow through the valve when the valve is in a closed configuration. A flap disposed adjacent the opening is able to temporarily and substantially close the opening to contribute to the regulation of retrograde flow proceeding through the valve.

Abstract: This invention relates to processes of preparing heterogeneous graft material from animal tissue. Specifically, the invention relates to the preparation of animal tissue, in which the tissue is cleaned and chemically cross-linked using both vaporized and liquid cross-linking agents, resulting in improved physical properties such as thin tissue and lowered antigenicity, thereby increasing the ease of delivering the tissue during surgery and decreasing the risk of post-surgical complication, respectively.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: An endoluminal support structure includes strut members interconnected by swivel joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A method for deploying a prosthetic valve assembly is provided. The prosthetic valve assembly replaces a deficient native valve and comprises a replacement valve supported on an expandable valve support. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary oslia. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.

Abstract: A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Abstract: A valved stent including a stent structure having a generally tubular body portion with an interior area, a first end, a second end, and a longitudinal axis; a valve structure including a plurality of leaflets and positioned within the interior area of the stent structure; and an invertible structure extending from one of the first and second ends of the stent structure. The invertible structure can be rotatable relative to the end of the stent structure from which it extends.

Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: The invention discloses an artificial valve (10, 20, 30, 50) for implantation in a mammal body, in or adjacent to a mammal blood vessel, comprising a casing (12, 37, 61) and a closing mechanism, with at least part of said closing mechanism being a first moving part (11; 21, 22; 31, 32, 33; 51) adapted to make movements relative to said casing (12, 37, 61), said movements being to assume an open and a closed position for opening and closing, respectively, the blood flow through said blood vessel, as well as to positions in between said open and closed positions. In the valve of the invention, the closing mechanism is adapted to be powered in its movements to the closed position, with the powering being at least in part by means of a power mechanism (76, 83) external to the blood vessel.

Abstract: An implantable prosthesis is provided having a radially-expandable tubular body and at least one skirt extending therefrom. The skirt terminates in a peripheral edge, wherein at least portions of the peripheral edge are free and displaceable to a greater diameter of the tubular body. Thus, with the implantable prosthesis being a stent-graft used to treat an aortic aneurysm (e.g., abdominal aortic aneurysm (“AAA”)), the skirt may be used to inhibit Type I endoleaks upon its selective displacement in response to irregular aortic shaping and/or aneurysm neck expansion. The skirt may actively inhibit Type I endoleaks by forming a physical barrier against flow between the tubular body and the aortic wall. In addition, the skirt may passively inhibit endoleak formation by sufficiently restricting blood flow to allow coagulation and clot formation, which would act as a barrier against endoleakage.

Abstract: A method is provided, including implanting at least a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve of a patient, implanting at least a second tissue-engaging element in a portion of a blood vessel that is in contact with an atrium of a heart of the patient, and drawing at least a first leaflet of the valve toward at least a second leaflet of the valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve of the patient. Other applications are also described.

Abstract: A prosthesis for locating at a branch region of a blood vessel. The prosthesis comprises a main conduit (10) having a tubular portion (11) with first and second ends (12,13), and at least one projecting portion (14,15,16) projecting from the first end of the tubular portion. One or more branch conduits (17,18) are connected to, and extend from the projecting portions or the tubular portion at a position adjacent the projecting portions. Portions of the prosthesis to which the branch conduits are attached may be more flexible and/or elastic than other portions of the prosthesis.

Abstract: A stented valve including a stent structure including a generally tubular body portion that has a first end and a second end, wherein an area adjacent the first end has a first stiffness, an area adjacent the second end has a second stiffness, and a central region between the areas at the first and second ends has a third stiffness that is less than the stiffness adjacent the first and second ends, wherein the stent structure can be reconfigured in its central area to match a curved patient anatomical region. The stented valve further includes a valve structure attached within the generally tubular portion.

Abstract: A valve such as an esophageal valve (1) has a normally closed configuration in which the valve (1) is closed and an open configuration in which the valve (1) is opened for flow through the valve (1). A support (102) for the valve (1) is adapted for mounting to a pre-deployed luminal prosthesis (140) intermediate a proximal end and a distal end of the predeployed luminal prosthesis (140).

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: Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

Abstract: Methods implant one or more fastening structure(s) in a targeted body region, e.g., within a hollow body organ or an intraluminal space. The fastening structure(s) are implanted to a vessel wall, and serve to secure a prosthesis within the hollow body organ or intraluminal space.

Abstract: An apparatus is provided that is useful in an embolization procedure and enables substantially unrestricted forward flow of blood in a vessel and reduces or stops reflux (regurgitation or backward flow) of embolization agents which are introduced into the blood. A method of using the apparatus is also provided.

Abstract: The disclosure relates to frames suitable for prosthetic implantable valves, and methods of treatment with such frames, to regulate blood flow and to be compliant in percutaneous delivery and, upon implantation, configured to conform to the changing shape of the body vessel or vein. The frames include at least one anchoring member attached to a support member at one or more attachments, and a valve member, preferably a monocuspid valve leaflet, attached to the support member. Preferred frames include two anchoring members with the support member in between the anchoring members. The support member preferably has a semielliptical shape and extends diagonally to sealingly contact the wall of the body vessel.

Abstract: A medical device comprises a support structure and one or more graft members comprising a valve portion and a constraining portion. The support structure has a first, unexpanded configuration and a second, expanded configuration. The constraining portion is adapted to substantially prevent the support structure from achieving the second, expanded configuration. The valve portion is adapted to permit fluid flow through a body vessel in a first direction and substantially prevent fluid flow through the vessel in a second, opposite direction.

Abstract: Prosthetic valves, methods of making medical devices, and methods of treatment are provided. The prosthetic valves of the invention have a valve portion moveable between first and second positions, and a spacing member that has a thickness and protects a portion of the valve portion from contact with a wall of a vessel in which the prosthetic valve is implanted, and/or another structural component of the prosthetic valve, such as a support frame.

Abstract: A venous valve with a frame and valve leaflets that provide a sinus pocket. The venous valve provides for unidirectional flow of a liquid through the valve.

Abstract: A replacement valve for implantation centrally within the orifice of a malfunctioning native heart valve. The valve is designed for minimally invasive entry through an intercostal opening in the chest of a patient and an opening in the apex of the human heart. The replacement valve includes either a separate anchor (11, 87, 111) or a combined anchor (67) that folds around the malfunctioning native valve leaflets, sandwiching them in a manner so as to securely anchor the replacement valve in a precise, desired location.

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 at 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: An endoluminal support structure includes strut members interconnected by swivel joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A venous valve is disclosed for implantation in and selectively restricting the outflow of blood from a penile vein to aid a user in achieving and/or maintaining an erection. The venous valve includes a self-expanding stent framework defining a blood flow lumen there through. The self-expanding stent framework is constructed to recoil from a radially compressed configuration in which the blood flow lumen is narrowed to restrict blood flow through the venous valve to a radially expanded configuration in which the blood flow lumen is fully open to permit unrestricted blood flow through the venous valve. A recoil delay component is attached to the self-expanding stent framework for slowing the recoil of the self-expanding stent framework to thereby provide an extended time period during which the blood flow lumen is narrowed and blood flow through the venous valve is restricted.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: Masked and controlled ion implants, coupled with annealing or etching are used in CVD formed single crystal diamond to create structures for both optical applications, nanoelectromechanical device formation, and medical device formation. Ion implantation is employed to deliver one or more atomic species into and beneath the diamond growth surface in order to form an implanted layer with a peak concentration of atoms at a predetermined depth beneath the diamond growth surface. The composition is heated in a non-oxidizing environment under suitable conditions to cause separation of the diamond proximate the implanted layer. Further ion implants may be used in released structures to straighten or curve them as desired. Boron doping may also be utilized to create conductive diamond structures.

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 at 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: A valve for use in a body lumen, where the valve includes a valve leaflet with delayed leaflet deployment relative an in vivo implant time. The valve includes a valve frame, a valve leaflet coupled to the valve frame. The valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve, and a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame for a predetermined time once implanted in vivo.

Abstract: A stent valve insertable in a body vessel containing a body fluid. The stent valve includes: a valve for at least partially controlling the flow of the body fluid in the body vessel; and a scaffold, the scaffold including: an anchoring section for anchoring the scaffold to said body vessel and a valve supporting section supporting the valve. The scaffold is substantially radially expandable from a scaffold retracted configuration to a scaffold expanded configuration. The valve supporting section is expandable over a greater range of radial expansion than the anchoring section.

Abstract: A vascular device comprising a plurality of vessel engaging members and a valve. The device is movable from a collapsed insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter. The plurality of vessel engaging members extend outwardly from the device for securely engaging the internal wall of a vessel upon expansion of the device to the second expanded position, wherein the vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward a first expanded position having a third diameter greater than the first diameter and less than the second diameter. In the first expanded position the valve is movable between an open position to allow blood flow therethrough to a closed position to prevent blood flow.

Abstract: Described are percutaneous vascular valves (11) free of attached support structures and deployment systems (31) and methods for providing attachment of the valves within a vascular vessel.