Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

Abstract: Described is a prosthetic device and methods for repairing a mitral valve having an annulus, leaflets, and chordae tendinae. The device comprises an elongate band including a plurality of reference elements that are located along the elongate band and protrude inwardly with respect thereto towards a center of the annulus, the plurality of reference elements being adapted to receive a corresponding plurality of artificial cords that are tied onto the reference elements and the plurality of reference elements adapted to be cut or removed in order to release the tied artificial cords.

Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets, to inhibit prolapse into the left atrium. At least one marginal chordae is severed, to permit leaflet closure against the band.

Abstract: The present disclosure relates to an arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve. With the method or the arrangement, leakage or regurgitation between a prosthetic heart valve and the surrounding valve tissue is prevented. In one embodiment, an arrangement for replacement or repair of a native heart valve is provided, which comprises a loop-shaped support (41) and a prosthetic heart valve (70) and wherein an outer segment (32) of the loop-shaped support (41) is positionable towards surrounding valve tissue of a native heart valve and wherein an outer surface (74) of the prosthetic heart valve (70) is positionable towards an inner segment (34) of the loop-shaped support (41) so as to prevent paravalvular leakage or regurgitation between the prosthetic heart valve (70) and the surrounding valve tissue of the native heart valve.

Abstract: A device for treating mitral regurgitation including an anchor which features one or more reinforcing bars, ribbon and suture.

Abstract: Implantable tissue structure modification devices are provided. Aspects of the tissue structure modification devices include first and second tissue securers separated by a contraction region, wherein the device is configured to be implanted at a cardiac location and assume a first constrained length that is longer than a second relaxed length. Also provided are methods of using the devices for tissue structure modification, as well as delivery systems and kits that find use in the methods. The devices and methods of the invention find use in a variety of different applications, including valve (e.g., mitral valve) structure modification.

Abstract: A method of testing the performance of a collapsible prosthetic heart valve includes wrapping an aortic band around an outer surface of a portion of an aorta, fastening a first end portion of the aortic band to a second end portion of the aortic band, implanting a collapsible prosthetic heart valve in the aorta at an implantation site, and flowing a pressurized fluid through the aorta. The aortic band may be positioned near the sinotubular junction of the aorta. When installed around the aorta, the aortic band reinforces the portion of the aorta so as to be more resistant to radial expansion.

Abstract: Valve retainers and delivery systems with valve retainers are disclosed. In certain embodiments, a portion of the valve retainer can rotate about a central axis of the delivery system relative to a different portion of the valve retainer. In certain embodiments, a first portion of the valve retainer can include a plurality of first orientation markings. In certain embodiments, a second portion of the valve retainer can include a second orientation marking, which can be aligned with a first orientation marking on the first portion of the valve retainer.

Abstract: A prosthetic remodeling annuloplasty ring for use in tricuspid or mitral valve repairs to provide support after annuloplasty surgery. The annuloplasty ring includes a relatively rigid core extending around an axis that is discontinuous to define two free ends. A suture-permeable interface surrounding the core includes floppy regions adjacent both free ends of the core. Sutures are used to attach the annuloplasty ring to the annulus, including at least one suture through each of the floppy regions to secure the free ends of the ring and minimize the risk of ring dehiscence, or pull through of the sutures through the annulus tissue. The floppy regions may project from each free end into the gap toward each other, be radially enlarged such as paddle-like extensions, or may comprise outwardly lateral extensions at the free ends of the core.

Abstract: Apparatus is provided for repairing a valve of a patient, the valve including an annulus and at least first and second leaflets. The apparatus includes at least a first discrete segment and a second discrete segment of an annuloplasty structure, each segment being shaped to provide a respective lateral wall, each lateral wall being shaped to define at least one lumen of the respective segment. The apparatus further includes at least a first and a second control wire, each control wire configured for sliding advancement through both the first and second segments. The first control wire is configured to control a relative disposition of a first end of the first segment and a first end of the second segment. The second control wire is configured to control a relative disposition of a second end of the first segment and a second end of the second segment. Other embodiments are also described.

Abstract: Holders for releasably holding annuloplasty rings prior to and during the implantation of the rings employ any of a variety of features relating to such things as holder shape, handle attachment structures, securement of a ring to the holder, and release of the ring from the holder. In one aspect, the holder includes a flexible bracket and a more rigid connector. In another aspect, the holder includes a flexible bracket and cutting blocks, wherein the interior surface of the cutting block is made of a higher durometer material than the bracket. The interior surface of the cutting block can be coated with a higher durometer material than the material of the bracket. In another aspect, the holder includes a flexible bracket and cutting blocks made of a higher durometer material than the flexible bracket.

Abstract: A prosthetic tricuspid remodeling annuloplasty ring for use in tricuspid valve repairs to provide annular support after reconstructive valve surgery. The ring maintains an optimal annular dimension to prevent excessive dilatation of the natural valve annulus while adapting to the dynamic motion of the tricuspid annulus during the cardiac cycle. An exemplary ring features a waveform contour and may be constructed of a titanium core having a varying cross-section for selective flexibility for good Z-axis or out-of plane movement. The “waveform” contour and selective flexibility of the different segments of this ring are designed to adapt to the complex motion of the annulus. This reduces the stress on the anatomical structures and therefore minimizes the risk of arrhythmia and ring dehiscence.

Abstract: Annuloplasty devices and methods for using the same are provided. Aspects of the devices include an at least partially annular body having at least one integrated tissue securing region. Also provided are methods of implanting the devices, as well kits for practicing the same. The devices, kits and methods find use in a variety of different applications, including cardiac valve repair applications.

Abstract: A prosthetic valve assembly and method of implanting same is disclosed. The prosthetic valve assembly includes a prosthetic valve formed by support frame and valve leaflets, with one or more tethers each having a first end secured to the support frame and the second end attached to, or configured for attachment to, to papillary muscles or other ventricular tissue. The tether is configured and positioned so as to avoid contact or other interference with movement of the valve leaflets, while at the same time providing a tethering action between the support frame and the ventricular tissue. The valve leaflets may be flexible (e.g., so-called tissue or synthetic leaflets) or mechanical.

Abstract: A medical device is disclosed that reinforces weakened or degenerated areas of at least a portion of a leaflet (24) of the heart valve. Function of a heart valve is thus improved. The medical device comprises at least a first partly flexible leaflet reinforcement patch (30) having an extension between an inner section (34) and an outer section (32), wherein said outer section (32) is configured to be oriented towards said annulus, and said inner section (34) is configured to be oriented towards said inner section of said valve tissue, and at least a portion of said inner section (34) of said flexible leaflet reinforcement patch (32) having at least one of said plurality of leaflets (24) in juxtaposition to said portion of said inner section (34), and said portion of said inner section (34) being positioned to provide reinforcement to said plurality of leaflets (24).

Abstract: A method according to one embodiment may include providing a heart valve implant including an anchor capable of engaging coronary tissue, a shaft coupled to said anchor, and a valve body coupled to said shaft. The method may further include at least partially collapsing the heart valve implant and percutaneously inserting the heart valve implant into a heart. The percutaneously inserted implant may be secured within the heart and may then be expanded. Of course, many alternatives, variations, and modifications are possible without departing from this embodiment.

Abstract: A prosthetic atrioventricular valve that includes a continuous tubular member having proximal and distal ends, the tubular member comprising an extracellular matrix (ECM) material, and a reinforcement member disposed in the tubular member lumen and attached to the distal end of the tubular member, the reinforcement member comprising at least two elongated linear members that are configured to connect the joined tubular and reinforcement members to a cardiovascular structure.

Abstract: In accordance with one embodiment of the present disclosure, a prosthetic valve is provided. The prosthetic valve includes an annulus, a pair of leaflets, and a pair of support elements. The annulus has a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions. The pair of leaflets extend from the annulus and are separated from each other by the pair of support elements. The first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the 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. A first flange unit is may be configured as a fabric sleeve covering the loop-shaped support. A portion of the fabric sleeve forms a flange that is attached to the annulus when said first loop-shaped support is abutting said heart valve. The flange is provideable by folding at least a portion of said sleeve over itself for forming a double layer of opposing fabrics thereof, such that said sleeve comprises a flange portion extending from said first loop-shaped support configured to overlap a surface of and form a collar around, at least a portion of said annulus.

Abstract: Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Abstract: A method for reducing regurgitation in a mitral valve using a blood flow controlling apparatus. The blood flow controlling apparatus comprises a leaflet coaptation member, a connecting member, and an anchor suitable for anchoring the apparatus to the interventricular septum. The leaflet coaptation member coapts with the native mitral valve leaflets during systole when disposed therebetween, thereby reducing mitral valve regurgitation. During diastole, the native leaflets release coaptation with the leaflet coaptation member, permitting blood flow from the left atrium into the left ventricle.

Abstract: Apparatus is provided, comprising (1) an annuloplasty structure, shaped to define a perimeter, and configured to be disposed at the annulus of the native valve of the patient; (2) a first adjusting mechanism, coupled to the annuloplasty structure, and configured to adjust the perimeter; (3) at least one longitudinal flexible member, having a first end portion, and a second end portion that is configured to be coupled to tissue of the ventricle of the heart of the patient; and (4) at least a second adjusting mechanism, coupled to the annuloplasty structure such that the second adjusting mechanism is slidable around at least part of the perimeter, coupled to the first end portion of the longitudinal flexible member, and configured to adjust a distance between the second adjusting mechanism and the second end portion of the longitudinal flexible member. Other embodiments are also described.

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 tissue plication device and method of using the same is described. The tissue plication device includes a helical fastener having a distal portion with a first pitch and a proximal portion with a second pitch that is smaller than the first pitch. The method includes introducing the distal tip of the helical fastener into the tissue and advancing the helical fastener to plicate the tissue. Another tissue plication device includes a helical fastener having a first configuration with a first pitch and a second configuration with a second pitch. The helical fastener in the first configuration is advanced into a tissue and then converted to the second configuration by applying a stimulus.

Abstract: Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Abstract: An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. Stranded cable provides a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as being able to pass through an 18Fr or smaller catheter, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle. The particular shape of the annuloplasty ring is fixed using a heat setting process.

Abstract: The implant (12) according to the invention comprises a tubular frame (16), a plurality of distal arms (18) capable of pressing on a first face of a tissue, and a plurality of proximal arms (20) having an end (62) connected to the frame and a free end (64) intended to press on a second face of the tissue to clamp the tissue. The implant comprises a first integral assembly including a first part (38) of the frame and the proximal arms (20), and a second integral assembly including a second part of the frame (40) and the distal arms (18), the first assembly and the second assembly being attached one on top of the other. The first part (38) of the frame is in the form of a proximal sleeve, extending longitudinally between a proximal end (41) and a distal end (43) of the sleeve. The connected end (62) of each proximal arm (20) is connected to the distal end (43) of the proximal sleeve (38), and the free end (64) of each proximal arm (20) extends beyond that distal end (43) of the proximal sleeve (38).

Abstract: The systems and devices and methods relate to surgical and percutaneous repair of heart valve regions. The systems and devices are structured to conform to the desired shape of a specific patient. The devices may include a mounting structure and a valve support onto which leaflets of the valve may coapt or rest. The devices may be structured to be mounted directly onto a leaflet of the valve.

Abstract: An annuloplasty device having an expandable member, a plurality of lobes, and a piercing wire is herein disclosed. In some embodiments, the lobes extend radially outwardly from the expandable member. The lobes each have a wire lumen disposed therethrough, and the piercing wire is extendable through the wire lumen of each lobe to secure the device to adjacent heart tissue. In some embodiments, the expandable member comprises an inflatable medical balloon. In addition, a method of implanting an annuloplasty device is disclosed.

Abstract: Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: An annuloplasty ring to resize a dilated aortic root during valve sparing surgery includes a scalloped space frame having three trough sections connected to define three crest sections. The annuloplasty ring is mounted outside the aortic root, and extends in height between a base plane and a spaced apart commissure plane of the aortic root. At least two adjacent trough sections are coupled by an annulus-restraining member or tether that limits the maximum deflection of the base of the annuloplasty ring. In use, the tether is preferably located in proximity to the base plane of the aortic root. The annuloplasty ring is movable between a first, substantially conical configuration occurring during a diastolic phase of the cardiac cycle, and a second, substantially cylindrical configuration occurring during a systolic phase of the cardiac cycle.

Abstract: An implantable device system for controlling the dimensions of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implantable devices are disclosed which employ various mechanisms 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 dimensions of the implants after the resumption of normal flow of anatomic fluids in situ.

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 prosthesis is adapted to operate in conjunction with native heart valve leaflets. The prosthesis includes an annulus and a skirt extending from the annulus. The skirt may be configured to be positioned through a native heart valve annulus, and the skirt may be movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets.

Abstract: Devices, systems, and methods employ an implant that is sized and configured to attach in, on, or near the annulus of a dysfunctional heart valve. In use, the implant extends either across the minor axis of the annulus, or across the major axis of the annulus, or both. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation.

Abstract: An apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. The diseased heart valve includes an annulus, anterior and posterior valve leaflets, and a subvalvular apparatus. The apparatus includes a substantially annular support member and at least one infra-annular support member securely connected thereto. The substantially annular support member has at least a first intermediate portion, a second intermediate portion, and a posterior end portion extending between the first and second intermediate portions. The posterior end portion is dimensioned for attachment to a posterior portion of the annulus of the diseased heart valve. The at least one infra-annular support member is securely connected to the substantially annular support member at a first location. The at least one infra-annular support member is dimensioned to extend below at least one of the posterior and anterior valve leaflets and across or behind at least one subvalvular structure.

Abstract: An implantable device system for controlling the dimensions of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implantable devices are disclosed which employ various mechanisms 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 dimensions of the implants after the resumption of normal flow of anatomic fluids in situ.

Abstract: Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes.

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: 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: One aspect of the present disclosure relates to a device for preventing or mitigating paravalvular leakage associated with a valve replacement procedure. The device can include a first ring, a second ring axially spaced apart from the first ring, at least one pad section extending between the first and second rings, and a plurality of centering wires attached to at least one of the first and second rings.

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 annuloplasty ring to resize a dilated aortic root during valve sparing surgery includes a scalloped space frame having three trough sections connected to define three crest sections. The annuloplasty ring is mounted outside the aortic root, and extends in height between a base plane and a spaced apart commissure plane of the aortic root. At least two adjacent trough sections are coupled by an annulus-restraining member or tether that limits the maximum deflection of the base of the annuloplasty ring. In use, the tether is preferably located in proximity to the base plane of the aortic root. The annuloplasty ring is movable between a first, substantially conical configuration occurring during a diastolic phase of the cardiac cycle, and a second, substantially cylindrical configuration occurring during a systolic phase of the cardiac cycle.

Abstract: The invention concerns a minimally invasive valve repair system (2), in particular a mitral valve repair system (2) or a tricuspid valve repair system. The system comprises a valve component (3), in particular a mitral valve component (3) or a tricuspid valve component, holding or adapted to hold a valve (4), in particular a mitral valve (4) or a tricuspid valve, respectively. The system (2) comprises a linker-component (6) by means of witch the valve component (3) is linked or linkable to an anchor support (5), in particular an in particular an aortic valve or aortic anchor support (5) or a pulmonic valve or pulmonary artery anchor support, respectively.

Abstract: Systems and methods for remodeling the annulus of a valve are disclosed. At least some embodiments disclosed herein are useful for resizing the mitral valve annulus in a safe and effective way. Such remodeling can be used to treat mitral valve regurgitation. At least some of the disclosed embodiments adjust the size of a valve annulus using magnetic forces. Other embodiments may include mechanisms for the manual adjustment of the annulus.

Abstract: Miniature axial flow pumps are implanted inside the heart or major arteries to provide hemodynamic support. These pumps commonly utilize tubular blood conduit tubes to transport blood across the aortic valve. The valve leaflets themselves are very thin and flexible, and will seal against the conduit if it is centered within the valve orifice. If the conduit is not centered, a leaflet can be pushed to the side of the aorta, preventing the leaflets from sealing and providing a path for backflow. If the blood flow conduit remains pushed against the side of the valve for a long period of time, thrombus may form in the crevice between the conduit and the aorta, causing serious thromboembolic events such as stroke, if the thrombus breaks free. The present invention provides a conduit support device that retains the conduit centered within the annulus of the natural heart valve.

Abstract: A device 10 for repairing mitral valve leaflets 2, 3 includes a jaw mechanism 15 that may be positioned adjacent a mitral valve leaflet 2, 3. The jaw mechanism 15 may move between an open position and a closed position by pivoting a first jaw relative 16 to a second jaw 18. The first jaw 16 may include a rivet 28 that may move from a stored position to an application position projecting away from the first jaw 16 when the jaw mechanism 15 is moved from the closed to the open position. Closing the jaws 16, 18 about a valve leaflet 2, 3 causes the rivet 28 to pierce the leaflet. The jaw mechanism 15 may then be rotated to wind the leaflet 2, 3 thereabout and again pierce the leaflet. The rivet 28 may then be released from the jaw mechanism 25 and the device 10 removed from the patient.

Abstract: A prosthetic anatomical device, such as, for example an annuloplasty prosthesis, is disclosed in which the prosthesis comprises a generally annular core and a cover surrounding the core, with at least a portion of the cover forming a cuff. In some embodiments, the cover may be particularly configured about the core to form the cuff. Various methods and structures for mitigating or retarding movement between the annular core and the fabric cover are also disclosed.

Abstract: Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Abstract: A system (1) for altering the geometry of a heart (100), comprising an annuloplasty ring; a set of elongate annulus-papillary tension members (21, 22, 23, 24), adapted for forming a link between said ring (10) and a papillary muscle, and a first set of papillary anchors (30) for connecting each of the tension members (21, 22, 23, 24) to the papillary muscle; and where said annuloplasty ring (10) has at least one aperture (12, 13); where each of said annulus-papillary tension members (21, 22, 23, 24) are extendable through said ring (10) through said apertures (11, 12, 13), and through an atrium to an exterior side of said atrium, such that the distance of each link between the annulus and the muscles is adjustable from a position exterior to the heart while the heart is beating.