Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.

Abstract: The present invention relates to a medical apparatus for the therapeutic treatment of an insufficient cardiac valve (3a, 3b). The aim of the present invention is to specify a medical apparatus which enables the therapeutic treatment of an insufficient cardiac valve, such as, for example, the mitral valve (3a) or the tricuspid valve (3b), which is arranged between a ventricle (1a, 1b) and an atrium (2a, 2b) of the heart, in a manner as simple as possible and as gentle as possible for the patient in a minimally invasive intervention. For this purpose, the medical apparatus according to the present invention comprises at least one valve means (10) which is designed to prevent in the implanted condition of the medical apparatus a systolic venous reflex return of blood from the atrium (2a, 2b) of the heart into at least one vein (4a, 4a?, 4b, 4b?, 4c, 4c?) which belongs to a venous system (4) which leads into the atrium (2a, 2b) of the heart.

Abstract: An intracardiac device comprising a ring-shaped body and one or more anchoring or stabilizing elements attached to said body, said elements being selected from the group consisting of levered anchoring arms, elongate anchoring arms, and lateral extension elements, wherein said device is able to move between two conformations, a collapsed conformation suitable for insertion into a delivery catheter, and an open conformation, suitable for implantation at a cardiac valve annulus.

Abstract: A method for treating paravalvular leakage at a location of a stented prosthetic valve includes the steps of delivering a clip to a location adjacent chordae tendinae of a native valve, and deploying the clip such that the clip captures at least some of the chordae tendinae of the native valve, thereby increasing tension in the captured chordae tendinae. The clip is delivered to the location in a collapsed stated and is released from a sheath convert to an undeflected or relaxed state. After the clip is released from the sheath, the clip is rotated to capture the chordae tendinae. The clip is then released from the delivery system and the delivery system is retracted.

Abstract: Heart valve prostheses are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame including a first portion and a second portion. In the collapsed configuration, the first portion is positioned adjacent to the second portion. In the expanded configuration, the first portion moves to be positioned within an interior area of the second portion.

Abstract: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex.

Abstract: Provided are methods, devices, and systems that can be used to deploy prosthetic devices within a bodily lumen of a patient. These methods and devices can include the securement of a prosthetic valve within a vascular lumen by driving one or more fasteners from a position on an expandable device through the valve and into or through a vascular wall.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame having a longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and consisting essentially row of diamond-shaded expandable cells. The frame also comprises three V-shaped structures spaced apart from the outflow circumferential structure and three struts longitudinally aligned with the longitudinal axis of the frame. The three struts are configured to facilitate mounting the biological tissue valve to the frame and interconnect the outflow circumferential structure to the three V-shaped structures. The frame also includes three undulating structures, each of the three undulating structures interconnecting respective adjacent V-shaped structures of the three V-shaped structures. The prosthetic heart valve is configured to be collapsed for introduction into a patient using; a catheter and to be expanded for deployment at an implantation site.

Abstract: Devices for fixturing a prosthesis to a first mass and methods of making and using the same are disclosed. Complementary fixturing devices and methods of making and using the same are also disclosed. The devices can be used to attach a heart valve gasket body to a biological annulus.

Abstract: A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a first flange unit being connected to said first loop-shaped support. The flange unit is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve.

Abstract: An implantable prosthetic valve assembly having a frame comprising a first frame portion and a second frame portion connected end-to-end exhibits enhanced rigidity. Each frame portion includes a plurality of circumferential struts formed with multiple bends, with the bends of the first frame portion having angles that are less than the bends of the second frame portion. Some embodiments of the frame have a semi-collapsed state in which the first frame portion is frustoconical and the second frame portion is generally cylindrical. A valve member is attached to the first frame portion.

Abstract: A prosthetic valve system for replacing a native aortic valve exhibiting regurgitation comprises a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure is radially collapsible and expandable, and deployable on an outflow side of the native aortic valve, circumscribing the native leaflets of the aortic valve. The THV is radially collapsible and expandable, and deployable in an annulus of the native aortic valve to frictionally engage the native leaflets between an interior surface of the support structure and the THY.

Abstract: Methods are provided for generating intraluminal prosthetic implants designed to fit onto specific anatomical locations within regions which are stable in terms of their motion in time.

Abstract: A medical device for holding a cardiac valve implant is disclosed comprising an elongate support defining a peripheral edge with a curvature about which the cardiac valve implant can be fitted, wherein the elongate support comprises a resilient portion for resiliently holding the cardiac valve implant in place in said device, and a support tool for holding a cardiac valve implant comprising first and second elongate support members being separate and radially movable in relation to each other, each having a curvature about which said cardiac valve implant can be fitted and a manipulator portion connected to said first and second elongate support members.

Abstract: A method for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural orifice or lumen which is either too large or too small. Implants are disclosed which employ various means for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

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: Methods and apparatus are provided for repairing or replacing a defective cardiac valve including an anchor having a double helix configured to engage the cardiac valve leaflets of a diseased or defective cardiac valve, and a replacement valve body disposed in an expandable stent configured to be disposed within the anchor so that the anchor limits expansion of the expandable stent. The expandable stent of the replacement valve body may be self-expanding or mechanically expanded, e.g., using a balloon catheter or catheter-based mandrel and the valve body may be formed of animal tissue or a synthetic fabric.

Abstract: An epicardial clip for reshaping the annulus of the mitral valve of a heart. The epicardial clip includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

Abstract: Embodiments of a method for implanting a prosthetic valve at the native mitral valve region of the heart, the prosthetic valve including a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Apparatus for delivering and implanting the prosthetic valve are also described.

Abstract: A method of using a prosthetic heart valve assembly can include implanting a first prosthesis directly into a native annulus. The first prosthesis can have a central longitudinal axis and a first engagement element. The method can also include engaging the first engagement element of the first prosthesis with a second engagement element of a second prosthesis to securely couple the second prosthesis to the first prosthesis. The second prosthesis can have a prosthetic valve. The first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element.

Abstract: An apparatus and method of use are disclosed for treating, preventing and terminating arrhythmias. In particular, the apparatus is implantable within or on various tissues and structures and is used to prevent or block conduction of aberrant impulses. A variety of methods of the present invention may be used to attack arrhythmias by short-circuiting impulses, inducing fibrosis, ablating tissue or inducing inflammation. In addition, the device and methods may also be used to treat aneurysms. The device may also be used to treat hypertension, and to function as a blood pressure regulator.

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: Disclosed is a stentless transluminally implantable heart valve, having a formed in place support. The formed in place support exhibits superior crush resistance when compared to conventional balloon expandable or self expandable stent based valves.

Abstract: Heart valve assembly systems and methods configured for medical interventional procedures. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: Biologically implantable prostheses and methods of using the same are disclosed. In one embodiment, a heart valve assembly includes a first annular prosthesis sized for introduction into a tissue annulus in a heart; a first magnet in the first prosthesis; a second valve prosthesis separate and disconnected from the first prosthesis and comprising a heart valve crown with leaflets, the second prosthesis configured for introduction into the tissue annulus after introducing the first prosthesis into the tissue annulus; and a second magnet in the second prosthesis, wherein an attraction between the first magnet and the second magnet engages the first prosthesis to the second prosthesis to attach the second prosthesis to the first prosthesis in the tissue annulus.

Abstract: A replacement heart valve, including a securing device and a non-return valve, the securing device including a resiliently deformable material adapted to adopt collapsed and non-collapsed configurations, the resiliently deformable material having a memory such that it returns to the non-collapsed configuration when not held under tension, whereby the valve is adapted to be secured within the valve annulus. Also featured is a method for replacing a heart valve and a kit, which use this replacement heart valve.

Abstract: The present invention refers to an annular prosthesis for mitral valve. In one of its embodiments the annular prosthesis for mitral valve is made up of a posterior half-ring and an anterior half-ring coupled to each other on a first transverse plane which defines a maximum width section of the prosthesis, characterized in that the ratio between the distance between said anterior half-ring and said posterior half-ring, as measured along a second plane, perpendicular to said first plane and equidistant to said couplings, and said maximum width of the prosthesis is lower than ¾.

Abstract: A method for heart valve surgery may include providing a cardiac valve ring and suture loops connected to the cardiac valve ring, accessing a valve annulus of the heart of the patient, stapling at least one of the sutures loop to the valve annulus, and parachuting the cardiac valve ring down the suture to the valve annulus after the stapling. The cardiac valve ring may be an annuloplasty ring, a replacement heart valve, or other medical device.

Abstract: A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves.

Abstract: A device for replacement of a bioprosthetic valve having an annulus (104) and one or more leaflets (105), the device having an outer housing (106) and an inner shaft (108) with a distal end (110). The outer housing (106) is slideable relative to the inner shaft (108) such that a portion of the inner shaft (108) may be revealed. A cap (112) is associated with the distal end (110) of the inner shaft (108), the cap (112) movable between a first position adjacent the inner shaft (108) and a second position displaced from the inner shaft (108). The cap (112) is adapted to trap a skirted valve frame (102) between said cap (112) and the inner shaft (108) when in the first position. The skirted valve frame (102) may be released by the cap (112) upon sliding of the outer housing (106) relative to the inner shaft (108) to reveal the inner shaft (108) and upon movement of the cap (112) to the second position. Also disclosed are associated methods.

Abstract: A method includes positioning an anchor deployment manipulator at least partially within a lumen of a sleeve of an annuloplasty ring, the sleeve having a lateral wall shaped to define the lumen, and the lumen extending longitudinally along a length of the sleeve. A portion of the sleeve that contains a distal end of the deployment manipulator is placed into an atrium in a vicinity of an annulus of an atrioventricular valve. An anchor is deployed from the distal end of the deployment manipulator through the lateral wall of the sleeve into cardiac tissue, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator forms an angle of between 45 and 90 degrees with the lateral wall of the sleeve at a point at which the anchor penetrates the lateral wall.

Abstract: A percutaneous prosthetic heart valve assembly comprising a radially expandable anchor docking member, the anchor docking member having an unexpanded state and an expanded state, in the expanded state, the anchor docking member comprising a mechanism for receiving and engaging an implantable heart valve and a bioabsorbable gasket member disposed about the anchor docking member, the bioabsorbable gasket member comprising a bioabsorbable polymer material, the bioabsorbable gasket member having an unexpanded and an expanded state.

Abstract: A prosthetic mitral valve assembly and method of inserting the same is disclosed. In certain disclosed embodiments, the prosthetic mitral valve assembly has a flared upper end and a tapered portion to fit the contours of the native mitral valve. The prosthetic mitral valve assembly can include a stent or outer support frame with a valve mounted therein. The assembly can be adapted to expand radially outwardly and into contact with the native tissue to create a pressure fit. One embodiment of a method includes positioning the mitral valve assembly below the annulus such that the annulus itself can restrict the assembly from moving in an upward direction towards the left atrium. The mitral valve assembly is also positioned so that the leaflets of the mitral valve hold the assembly to prevent downward movement of the assembly towards the left ventricle.

Abstract: A device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

Abstract: A method for implanting a heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a multi-lobed connection adapter to secure the second prosthesis to the first prosthesis. In one embodiment, the adapter is arranged to allow the second prosthesis to be secured to the first prosthesis in a predetermined angular orientation. During use, the first annular prosthesis is implanted into the annulus, and the second valve prosthesis is inserted into the annulus. The adapter secures the second prosthesis relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and secure the second prosthesis to the first prosthesis in the predetermined angular orientation.

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: Devices and methods for treating or repairing a heart are disclosed. The device includes at least one anchor configured to engage tissue of a heart and a thread or other elongate member adapted to be coupled to the anchor and secured to heart tissue. The anchor may be attached to papillary muscle tissue and an elongate member may be attached to a valve leaflet for creating artificial chordae tendinae, thereby treating mitral valve prolapse. In another application, multiple anchors may be deployed within a ventricle and the threads pulled together for reducing dilation of a ventricle. A locking mechanism is provided for capturing and locking the threads together, thereby maintaining the ventricle in the reshaped condition.

Abstract: A surgically implantable multiple orifice heart valve having a valve frame with at least two orifices, each of which can accommodate a tissue valve. The multiple orifice heart valve includes a stent frame having a first side, an opposite second side, and multiple orifices or openings, each of which extends from the first side to the second side of the stent frame and is adjacent to at least one of the other multiple orifices or openings.

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: The disclosure pertains to profile reduction seals associated with heart valve replacements which may reduce or eliminate paravalvular regurgitation and methods of fabricating such seals. The generally cylindrical multilayer seals of the disclosure include a crown-like end and reinforcing elements which facilitate compression of the seal and associated device by minimizing bunching of the seal as it enters a delivery system.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: Described herein are systems and methods for operation of a prosthetic valve support structure (32) having additional reinforcement coupled with panels (36). Multiple support members (620) are distributed across the inner surface of the valve support structure (32) at regular intervals. Each support member (620) can include a looped portion (621) to act as a hinge (52). Each looped portion (621) is in a location coincidental with the interlace between adjacent panels (36).

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Abstract: A surgical sutureless valve that is attached to a stent frame for delivery to a location in a patient using percutaneous implantation devices and methods.

Abstract: A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.

Abstract: Apparatus is described for use with a native heart valve of a subject, the apparatus including (1) a prosthetic valve support, comprising an upstream support portion, the upstream support portion having (a) a compressed configuration and an uncompressed configuration in which the upstream support portion has an inner perimeter that defines an opening; and (2) a prosthetic valve, advanceable into the opening defined by the upstream support portion, and intracorporeally couplable to the upstream support portion by being expanded within the opening defined by the upstream support portion, the apparatus being configured such that, when the prosthetic valve is expanded within the opening defined by the upstream support portion, the expansion of the prosthetic valve is restricted by the inner perimeter of the upstream support portion, without causing the prosthetic valve support to apply a radially-expansive force to the native annulus. Other embodiments are also described.

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