Abstract: Apparatus is provided including an implant structure (22, 122, 1122), a rotatable structure (2900) coupled to the implant structure (22, 122, 1122) in a vicinity of a first portion thereof, and a flexible member (30). At least a first portion of the 5 flexible member (30) is disposed in contact with the rotatable structure (2900), and at least one end portion of the flexible member (30) is not disposed in contact with the rotatable structure (30). In response to rotation of the rotatable structure (2900) in a first direction thereof, successive portions of the flexible member (30) contact the rotatable structure (2900) to pull the at least one end portion of the flexible member 0 (30) toward the first portion of the implant structure (22, 122, 1122), and responsively to draw the first and second portions of the implant structure (22, 122, 1122) toward each other. Other applications are also described.

Abstract: An implantable structure includes a flexible sleeve, having first and second sleeve ends, and a contracting assembly, which is configured to longitudinally contract the sleeve, and includes a contracting mechanism, which is disposed longitudinally at a first site of the sleeve, and a longitudinal contracting member, having (a) a first member end, (b) a second member end, which is coupled to the sleeve longitudinally at a second site longitudinally between the first site and the second sleeve end, exclusive, and (c) a first member end portion, which is coupled to the contracting mechanism. The sleeve is arranged in a closed loop, such that first and second portions of the sleeve together define a longitudinally overlapping portion of the sleeve. The implantable structure is configured such that the contracting assembly longitudinally applies a longitudinal contracting force only between the first and the second sites, and not along the overlapping portion.

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: An implantable device is provided for controlling at least one of shape and size of an anatomical structure or lumen. An implantable device has an adjustable member configured to adjust the dimensions of the implantable device. An adjustment tool is configured to actuate the adjustable member and provide for adjustment before, during and after the anatomical structure or lumen resumes near normal to normal physiologic function.

Abstract: A device, such as a prosthetic heart valve, for implantation in a patient's valve, having one or more visible markings configured to be aligned with one or more anatomical structures of the patient's valve, such as an annulus or a commissure. The markings facilitating accurate implantation of the device at a proper depth or in a proper orientation.

Abstract: A valve mounting apparatus having an elongated tubular mesh structure with proximal and distal ends, a cardiovascular structure engagement region disposed between the proximal and distal ends, and a lumen therethrough, the distal end of the structure including a valve engagement region that is configured to engage a first end of a prosthetic valve, the mesh structure being configured to transition from a pre-deployment configuration, wherein the structure is capable of being disposed at a cardiovascular valve region, such as a valve annulus region, to a post-deployment expanded configuration, wherein the cardiovascular structure engagement region is anchored to the cardiovascular valve region.

Abstract: Apparatus is provided for use with a native valve of a heart of a subject, the apparatus including (1) an annular upstream support portion, configured to be transluminally placed against an atrial surface of the native valve; (2) a tissue-engaging element that includes a coupling portion configured to be transluminally coupled to tissue in a ventricle of the heart; (3) an elastically-stretchable holding element, configured to secure the upstream support portion against the atrial surface by elastically coupling the coupling portion to the upstream support portion; and (4) a prosthetic valve, configured to be transluminally delivered to the native valve and intracorporeally coupled to the upstream support portion subsequently to the securing of the upstream support portion against the atrial surface. Other embodiments are also described.

Abstract: An implantable device is provided for controlling shape and/or size of an anatomical structure or lumen. The implantable device has an adjustable member configured to adjust the dimensions of the implantable device. The implantable device is housed in a catheter and insertable from a minimally invasive surgical entry. An adjustment tool actuates the adjustable member and provide for adjustment before, during or after the anatomical structure or lumen resumes near normal to normal physiologic function.

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: 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: Expandable prosthetic valve devices for repair or replacement of a native valve in a heart of a patient and associated, systems and methods are disclosed herein. An expandable prosthetic valve device configured in accordance with a particular embodiment of the present technology can include a radially-expandable support having an expandable outer wall and a lumen defined by the outer wall. The device can also include a valve in the lumen and coupled to the support and a self-expanding retainer coupled to the outer wall. The retainer can have a structural braid configured to form a first annular flange on the outer wall of the support, and an occlusive braid configured to reduce blood flow through the retainer.

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 self-expandable ring seals a gap between a medical device and adjacent body tissue. The ring is disposed about the medical device and configured to self-expand from a first radius in a compressed condition to a second radius in an expanded condition, the second radius being greater than the first radius. The ring may be formed from a compliant biocompatible foam configured and arranged to conform to the body tissue.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity, and an outer skirt positioned annularly around an exterior of the expandable frame. In some embodiments, the outer skirt can extend outward from the frame and be secured to an outwardly extending anchor on the frame to create an axial barrier to fluid flow exterior to the frame when deployed within the body cavity.

Abstract: A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods.

Abstract: A prosthetic valve for implanting in a patient's native valve has a self-expanding frame that comprises a first end, a second end opposite the first end, an anterior portion, and a posterior portion. The self-expanding frame has an expanded configuration adapted to engage tissue at a treatment site, and a collapsed configuration adapted to be delivered to the treatment site. The expandable frame also comprises a self-expanding atrial skirt near the second end, a self-expanding ventricular skirt near the first end, a self-expanding annular region disposed between first and second ends, a first self-expanding anterior tab disposed on the anterior portion, and a self-expanding foot coupled to the posterior portion and extending radially outward. The foot has an outer surface for engaging the tissue thereby facilitating anchoring of the prosthetic valve and minimizing or preventing rotation of the prosthetic valve.

Abstract: Annuloplasty rings are employed to treat heart valve defects, such as regurgitation. Synching the heart tissue to the ring restores the valve opening to its approximate original size and operating efficiency. Adjustable annuloplasty rings allow for a proper degree of synching both during open heart surgery and over the patient's lifetime. A subcutaneous port may be coupled to an adjustable annuloplasty ring such that an external activation energy generator can be used to heat the adjustable annuloplasty ring and thereby adjust the size of the annuloplasty ring.

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: 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: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. One embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve member. In some cases, the prosthetic valves also include ventricular anchors and/or an atrial portion coupled to and disposed outside of the main body. Methods, devices, and systems for delivering such prosthetic valves to the native mitral valve and implanting them therein are also provided.

Abstract: A support for an adjustable annuloplasty ring generally includes a body and a groove. The body has a first end, a second end and an outer surface. The body may also include an inner surface defining a longitudinal bore. The outer surface is configured to slidably receive an annuloplasty ring and a length of adjustable suture. The groove is formed along at least a portion of the outer surface of the body and is dimensioned to receive at least a portion of the suture.

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: 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: An annuloplasty device includes a plurality of corkscrew anchors. The annuloplasty device further includes a core wire extending along the length of the device and at least one corkscrew wire which is operably connected to the corkscrew anchors to screw the corkscrew anchors into heart tissue. One or more of the corkscrew wires can include a drive key; the corkscrew anchors are connected to a sleeve with a keyway that engages the drive key on the corkscrew wires.

Abstract: A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

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 method is provided for treating mitral valve regurgitation, including inserting a band around between 90 and 270 degrees of a mitral valve of a heart, including around at least a portion of a posterior cusp of the valve, in a space defined by (a) a ventricular wall, (b) a ventricular surface of the posterior cusp in a vicinity of an annulus of the valve, and (c) a plurality of chordae tendineae of one or more types of chordae tendineae selected from the group consisting of: second-order chordae tendineae and third-order chordae tendineae. The method also includes applying pressure to the posterior cusp by inflating the band.

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: Apparatus is provided including an implantable structure (22), including a flexible sleeve (26), having first and second sleeve ends (49, 51), a contracting assembly (40), which is configured to longitudinally contract the sleeve (26). The contracting assembly (40) includes a contracting mechanism (28), which is at a first site of the sleeve (26); and a longitudinal contracting member (30), having (a) a first member end, (b) a second member end (53), coupled to the sleeve (26) at a second site longitudinally between the first site and the second sleeve end (49 or 51), exclusive. A force-distributing element (540) is couplable to the sleeve (26) in a vicinity of the second sleeve end (49 or 51), element (540) is configured to distribute a contraction force by the contracting member (30) between the second member end (53) and the second sleeve end (49 or 51). Other applications are also described.

Abstract: The present invention comprises a novel and safer mechanism of deployment using a self-positioning, self-centering, and self-anchoring method. To embody the present invention, a disk-based valve apparatus allowing the repositioning and retrieval of the implantable valve while working on a dysfunctional valve structure is disclosed. The disk-based valve apparatus may comprise one or more disks, either proximal or distal, a valve-housing component and a valve component. The one or more disks may be either proximal or distal, may be either connected to each other or disconnected from each other and may either be symmetrical or have different shapes and dimensions. The disk-based valve apparatus may be self anchoring, such as anchored by pressure from the one or more disk, or may be anchored using any anchoring.

Abstract: An artificial mitral valve is anchored in the left atrium by placing the valve between the annulus of the natural mitral valve and an artificial annulus. The artificial annulus is formed by inserting a tool into the coronary sinus, and adjusting the tool to force the wall of the left atrium to form an annulus above the artificial valve, this locking it in place and forming a hemostatic seal.

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: 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: A heart valve assembly comprises a first prosthesis configured to expand from an unexpanded state to an expanded state at which the first annular prosthesis contacts native tissue of a body lumen. The heart valve assembly also comprises a second prosthesis comprising a valve, and a connection adapter that secures the second prosthesis to the first prosthesis, the connection adapter having a multi-lobed circumference.

Abstract: An artificial mitral valve is anchored in the left atrium by placing the valve between the annulus of the natural mitral valve and an artificial annulus. The artificial annulus is formed by inserting a tool into the coronary sinus, and adjusting the tool to force the wall of the left atrium to form an annulus above the artificial valve, this locking it in place and forming a hemostatic seal.

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: This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet.

Abstract: An adjustment assembly for an adjustable prosthetic valve device includes a gearbox housing formed from two gearbox shells coupled to one another and held together by two gearbox sleeves each having an internal cavity adapted to accommodate respective lateral portions of the gearbox shells when the gearbox shells are coupled to one another. A gear assembly, including a center gear and two driven gears, is supported within the gearbox housing. Gear teeth of each of the driven gears engage gear teeth of the center gear such that rotation of the center gear causes rotation of the driven gears. At least one of the driven gears is adapted to engage a transmission mechanism that transmits the rotation thereof to another part of the adjustable prosthetic valve device to accomplish an adjustment to the size and/or shape of the adjustable prosthetic valve device.

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 adjustment tool enables manipulation of a prosthetic anatomical device such as an annuloplasty ring. The tool includes a compression member which is operative for retarding rotation of the adjustment shaft to preclude inadvertent rotation thereof during use of the tool by the surgeon. A locking device is associated with the adjustment tool to enable the releasable attachment of the tool to the anatomical device during its adjustment by manipulation of the tool. The locking device is oriented into operative and inoperative positions by the engagement and disengagement of locking elements. A scale may be provided on the adjustment tool to assist a surgeon in determining the size or amount of adjustment to the size of the anatomical device during its adjustment.

Abstract: A device for anchoring a prosthetic heart valve on biological tissue, includes first and second anchoring assemblies, mutually couplable to secure biological tissue therebetween. The anchoring assemblies include at least one pair of complementary arched portions having anchoring formations for anchoring on the biological tissue. The anchoring formations include integral extensions of the anchoring assemblies extending radially outwardly of one of the anchoring assemblies.

Abstract: A device for anchoring on biological tissue a prosthetic heart valve, includes first and second anchoring assemblies mutually couplable to secure biological tissue therebetween. The anchoring assemblies include at least one pair of complementary arched portions having anchoring formations for anchoring on the biological tissue. The anchoring formations include integral extensions of the anchoring assemblies extending radially outwardly of one of the anchoring assemblies.

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: The devices and methods relate to surgical and percutaneous repair of heart valve regions. The devices may be structured to conform to the desired shape of a specific patient. The devices may include a frame and an artificial body onto which leaflets of the valve may coapt or rest.

Abstract: A method for stabilizing a cardiac valve annulus is provided. The method includes intravascularly delivering a prosthesis to a region of a cardiac valve, expanding the prosthesis to secure the prosthesis to the region of the cardiac valve, and reducing the inner diameter of the prosthesis to form the region of the cardiac valve into a predefined shape.

Abstract: Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

Abstract: The invention provides a device (50) and system for treating a heart valve having an anchor (54, 56) and one or more sutures attached to the anchor. The anchor has an expanded deployed configuration and a low caliber undeployed configuration. A delivery in a heart includes catheter and a needle slidable in the lumen of the catheter. The distal end of the catheter is inserted through the myocardium of the heart until the catheter tip is juxtaposed to the underside of the valve leaflet to be treated. The leaflet is then pierced with tip of the needle. The needle is pushed until the anchor in its undeployed configuration passes through the needle tip and is released from the catheter. The anchor is then brought to its deployed configuration on one or both surfaces of the valve leaflet.

Abstract: An implantable device for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implants area 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 producers 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: An implant device for a heart having a first chamber and a second chamber and a native valve between the chambers, the device having an elongate body having opposing ends, the body being configured to be implanted within the heart and extend through the native valve with a first end in the first chamber and a second end in the second chamber; a first resiliently compressible part of the body being adapted to be compressively engaged by the heart within the first chamber; and a second resiliently compressible part of the body being adapted to be compressively engaged by the heart within the second chamber; so that the first and second parts hold the elongate body in a desired position within the heart by said compressive engagement. The device can be employed as a prosthetic device replace or supplement a native valve such as the mitral valve.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.