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, such as fibroelastic deficiency (FED), Marfan's or Barlow's. 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: The present invention is an apparatus designed to effectuate restoration of normal aortic valvular function where there is aortic valvular regurgitation either primary or secondary to diseases of the aorta such as aortic aneurysm, aortic dissection, rheumatic aortic disease annuloaortic ectasia and etc. is present. The present invention provides an apparatus for repairing aortic annulus composed of (1) a band type inner stabilizer (sometimes ring type inner stabilizer) which is implanted in the true aortic lumen to fix the aortic annular diameter and (2) an outer felt stabilizer which is implanted on the outside surface of aorta to support the inner stabilizer.

Abstract: A set of annuloplasty rings progressively sized to take into account more of the common pathologies. The proportional shapes of each ring as the orifice size changes vary. For instance, the larger rings have larger minor axis dimensions relative to their major axis dimensions.

Abstract: Prosthetic medical devices with delayed valve function and in situ remodeling of a portion thereof are provided, as well as methods of manufacturing the medical devices and methods of treatment using the medical devices. The medical devices may be adapted to initially maintain a remodelable material within a body vessel in a first configuration suitable to contact the remodelable material with a body fluid contacting the remodelable material for a first time period or a second configuration adapted to regulate the flow of body fluid contacting the remodelable material. The medical devices may include a releasable holding member configured to retain the remodelable material in the first configuration.

Abstract: An apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. The apparatus includes an annular support member and at least one posterior leaflet support member. The annular support member has an anterior end portion, a posterior end portion, and oppositely disposed first and second intermediate portions extending between the end portions. The at least one posterior leaflet support member is securely connected to the annular support member and is dimensioned to extend across a portion of a free edge of a posterior valve leaflet. The posterior leaflet support member comprises an arcuate center portion integrally formed with and extending between first and second end portions. The arcuate center portion has a concave shape relative to the anterior end portion. At least one of the first and second end portions is securely attached to the posterior end portion.

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 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 method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Abstract: Valve repair apparatus and methods for ensuring proper coaptation and operation of the leaflets of a heart valve. Main aspects of the disclosure relate to devices including a support member configured for attachment to the heart valve annulus, a post extending from the support member away from the plane of the annulus and a connector coupled with the post and configured for attachment to at least one of the leaflets. The various embodiments may include a replacement heart valve connected with the support member for facilitating full replacement as opposed to near repair of an existing native heart valve. Various other devices include support structure and one or more posts connected to opposite sides of the support structure and extending from one side of the valve annulus to another to modify the shape of the annulus.

Abstract: Devices, systems and methods retain a native heart valve leaflet to prevent retrograde flow. The devices, systems, and methods employ an implant that, in use, rests adjacent a valve annulus and includes a retaining structure that is sized and shaped to overlay at least a portion of one or more native valve leaflets. The retaining structure retains the leaflet or leaflets it overlays, to resist leaflet eversion and/or prolapse. In this way, the implant prevents or reduces regurgitation. The implant does not interfere significantly with the opening of and blood flow through the leaflets during periods of antegrade flow.

Abstract: Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.

Abstract: A system for using a barbed tubular retainer in the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make placations in the subvalvular region of the mitral valve annulus. Fourth, a barbed tubular retainer deployed by the plication device in order to retain the plicated tissue in the plicated form. Alternatively, the fourth device is a retainer delivery catheter that enables delivery of a barbed tubular retainer that is attached to its distal end over the outside of the plication device.

Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form. A transseptal approach may be used to plicate and retain tissue on the atrial side of the mitral valve to achieve a reduction in mitral valve regurgitation.

Abstract: A cardiovascular prosthetic valve, the valve comprising an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure, and a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

Abstract: A replacement heart valve apparatus. The heart valve apparatus includes a stent and a valve frame having a substantially cylindrical body defining a lumen. The valve frame includes a plurality of curved wire pairs attached to the substantially cylindrical body. Each curved wire pair includes an inner curved wire and an outer curved wire. The wire frame further having a plurality of leaflets. Each leaflet is attached to a respective inner curved wire and extends over a respective outer curved wire, so as to position the body of the leaflet within the lumen of the valve frame.

Abstract: A medical apparatus and method for remodeling a mitral valve annulus adjacent to the coronary sinus includes an elongate body having a proximal end and a distal end. The elongate body is movable from a first, flexible configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus.

Abstract: The present invention relates to a medical device and uses thereof that supports or changes the shape of tissue near a vessel in which the device is placed. The present invention is particularly useful in reducing mitral valve regurgitation by changing the shape of or supporting a mitral valve annulus. The device includes a support structure, a proximal anchor adapted to be positioned in a superior vena cava, and a distal anchor adapted to be positioned in a coronary sinus. The support structure engages a vessel wall to change the shape of tissue adjacent the vessel in which the intravascular support is placed.

Abstract: An assembly for effecting the condition of a mitral valve annulus includes a mitral valve therapy device, a coupling structure carried by the device, a catheter, a second coupling structure, and a locking member. To implant the device, the device is first releasably locked to a pushing member by the coupling structures and the locking member. When the device is positioned within the coronary sinus adjacent the mitral valve annulus and deployed, the coupling structures may be released from each other by the release of the locking member.

Abstract: Devices and methods for treating mitral regurgitation by reshaping the mitral annulus in a heart. One preferred device for reshaping the mitral annulus is provided as an elongate body having dimensions as to be insertable into a coronary sinus. The elongate body includes a proximal frame having a proximal anchor and a distal frame having a distal anchor. A ratcheting strip is attached to the distal frame and an accepting member is attached to the proximal frame, wherein the accepting member is adapted for engagement with the ratcheting strip. An actuating member is provided for pulling the ratcheting strip relative to the proximal anchor after deployment in the coronary sinus. In one preferred embodiment, the ratcheting strip is pulled through the proximal anchor for pulling the proximal and distal anchors together, thereby reshaping the mitral annulus.

Abstract: The present invention provides a valve configured for insertion on the proximal and distal sides of a heart valve annulus to replace the heart valve of a patient. The valve comprises a first substantially annular portion adapted to be positioned on a proximal side of the annulus of a patient and a second substantially annular portion adapted to be positioned on a distal side of the annulus of a patient, wherein at least one of the first and second substantially annular portions is movable towards the other portion to a clamped position to clamp around the annulus. The second portion has a flow restricting portion extending therefrom and is movable between a first position to permit the flow of blood and a second position to restrict the flow of blood. In one embodiment, the valve has a suture joining the first and second portions to draw the first and second portions into closer proximity and a cinch member to secure the suture to maintain the first and second portions in the clamped position.

Abstract: A method and system according to one embodiment may include a plurality of apparatus configured to percutaneously deliver a heart valve implant. The method and system may include an implant comprising an anchor configured to engage cardiac tissue, a shaft coupled to the anchor, and a valve body coupled to the shaft. The method and system 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.

Abstract: Methods, devices and systems are disclosed to treat atrioventricular valve regurgitation accessed through the vasculature, and by standard and minimally invasive surgical techniques. Isolated leaflet fixation and annulus treatment systems are developed.

Abstract: A heart valve implant may include a shaft and an anchor configured to be coupled to an end of the shaft. A spacer may be coupled to a portion of the shaft and comprise a plurality of individual segments including a first and at least a second individual segment. The first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an exterior surface of the first segment and may have at least one cross-section dimension which is greater than an internal cross-sectional dimension of a delivery lumen. Additional segments may be coupled to an inner, adjacent segment. The segments may include a collapsible body portion to facilitate percutaneously delivery through a lumen. The segments may define an outer surface of the spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position.

Abstract: Annuloplasty device for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the device comprising: a ring body comprising: an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively; and first and second ends; wherein the ring body is curvilinear, with substantially no flat portions, forming a shape, and the ends are configured such that when the device is implanted, the first end will be located near the junction of the septal and anterior aspects of the annulus and the second end will be located near the septal aspect of the annulus. Related methods.

Abstract: The present disclosure is directed to an external cardiac basal annuloplasty system (ECBAS or BACE-System: basal annuloplasty of the cardia externally) and methods for treatment of regurgitation of mitral and tricuspid valves. The BACE-System provides the ability to correct leakage of regurgitation of the valves with or without the use of cardiopulmonary bypass, particularly when the condition is related to dilation of the base of the heart. This ECBAS invention can be applied to the base of the heart epicardially, either to prevent further dilation or to actively reduce the size of the base of the heart. Such devices also include an extension thereto for the treatment of localized myocardial defects, scars and damage.

Abstract: For the treatment of an insufficient cardiac valve or a cardiac valve with a stenosis, a device is provided that comprises a micro axial pump (40). The pump portion (14) of the micro axial pump carries a dilating device (18) suitable for pushing open a stenosis in a valve. The dilating device is designed as a high-pressure balloon. During dilation, the micro axial pump (40) operates so that the heart is relieved. With insufficient cardiac valves, a stent (21) is fastened to the dilating device (17), the stent surrounding a flexible cardiac valve prosthesis (20). By dilation, the stent (21) is pressed against the insufficient cardiac valve and the same is passivated. The cardiac valve of the cardiac valve prosthesis is unfolded to assume the function of the natural cardiac valve.

Abstract: Devices and methods for the repair of a defective cardiac valve are provided. The implantable devices provide a leaflet coaptation surface and correct for one or more prolapsing segments of a valve leaflet. The methods involve implanting one or more devices within the defective cardiac valve. In certain embodiments, the devices and methods correct for billowing leaflets and/or a dilated valve annulus.

Abstract: A system and process for correction of regurgitation of heart valves. With mitral valves in particular, the anterior leaflet is advanced through use of a D-plasty patch and a narrow annuloplasty ring which compresses the lateral dimension on of the valve. The sizes of the patch and ring are selected to provide a sufficient advancement of the leaflet to restore the surface of coaptation.

Abstract: A system and process for correction of regurgitation of heart valves. With mitral valves in particular, the anterior leaflet is advanced through use of a D-plasty patch and a narrow annuloplasty ring which compresses the lateral dimension of the valve. The sizes of the patch and ring are selected to provide a sufficient advancement of the leaflet to restore the surface of coaptation.

Abstract: A heart valve implant according to one embodiment may include a shaft extending generally along a longitudinal axis of the heart valve implant having at least one anchor configured to be coupled to a first end of the shaft. A spacer may include a plurality of individual segments each including at least one passageway configured to be disposed about the shaft. The plurality of individual segments may define an outer surface of the spacer which is configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position. The plurality of individual segments may each having a length and at least one cross-section dimension no larger than an internal cross-section of a lumen of a delivery catheter.

Abstract: In a method of treating valvular insufficiency in a patient, a plurality of filaments (2) are used to engage tissue at spaced apart locations of an annulus (1) of the valve being treated. The engaged filaments (2) are drawn inward so as to draw the engaged tissue around the valve annulus (1) inward. The filaments (2) are then secured with the engaged tissue in the drawn-in configuration. Inward drawing of the engaged tissue improves valve function by reducing the valve annulus (1). Alternatively or additionally, anchor means may be used to secure the filaments to a region of robust tissue, thus drawing the engaged tissue toward the anchor means to further improve valve function.

Abstract: A device for shrinking and/or reinforcing the heart valve orifices includes a thick link (1) made of a bioresorbable, soft and curved material. It is secured at one of its ends to at least a thin yarn (3) whereof the end is fixed to a curved needle.

Abstract: An annuloplasty ring (for use as a heart valve prosthesis) has a non-planar shape and different lateral flexibilities at different points as one proceeds annularly around the ring. These different lateral flexibilities may be achieved in different ways such as by changing the material and/or cross-sectional size, shape, or other stiffness-imparting characteristics of the cross section.

Abstract: An anchor anchors a therapeutic device having an elongated body within a body lumen. The anchor includes a fixation member carried on the device which is adjustable from a first configuration that permits placement of the device in the body lumen to a second configuration that anchors the device within the body lumen. The anchor further includes a lock that locks the fixation member in the second configuration. The fixation member may be locked in any one of a plurality of intermediate points between the first configuration and a maximum second configuration.

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.

Abstract: A prosthetic tricuspid remodeling annuloplasty ring having two free ends and at least one inward bow to help reduce chordal tethering. The ring may have segments corresponding to the anterior, posterior and septal leaflets, with inward bows located adjacent one, two or all leaflets. Convex corners separate the concave inward bows, with inflection points therebetween. The ring has a semi-rigid inner body covered by fabric or a suture interface such as silicone and fabric.

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: 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 with a catheter. In an embodiment, the endoprosthesis has a 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 collapsed mode during the process of introducing it into the patient's body and an expanded mode when it is implanted. The endoprosthesis may be introduced into a patient's body and expanded via a catheter. In an embodiment, the catheter has first and second slide mechanisms configured to independently manipulate first and second sleeve elements to sequentially expand the endoprosthesis from the collapsed mode to the expanded mode.

Abstract: A cardiac-valve prosthesis is adapted for percutaneous implantation. The prosthesis includes an armature adapted for deployment in a radially expanded implantation position, the armature including a support portion and an anchor portion, which are substantially axially coextensive with respect to one another. A set of leaflets is coupled to the support portion. The leaflets can be deployed with the armature in the implantation position. The leaflets define, in the implantation position, a flow duct that is selectably obstructable. The anchor portion can be deployed to enable anchorage of the cardiac-valve prosthesis at an implantation site.

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

Abstract: Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

Abstract: This invention relates to a system used to fashion, size, and implant a tissue annuloplasty band. This system comprises (1) a device to cut tissue; (2) a device to fashion (i.e., roll, fold, bunch, etc.) the tissue into a band (i.e., the tissue annuloplasty band); and (3) a sizer that comprises an mounting ring which allows for determining and maintaining the proper size and shape of the tissue annuloplasty band while it is attached to the annulus of a heart valve. These components can be used alone, together as a system, or in any combination to fashion, size, and/or implant the tissue annuloplasty band.

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: 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: 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 improved medical implant for treating mitral regurgitation is provided. The medical implant comprises proximal and distal anchors connected by a bridge. The medical implant is configured to be delivered into a coronary sinus using a minimially invasive procedure. The bridge is preferably made of a shape memory material which is biased to contract after the implant is delivered. The medical implant further comprises a reinforcement mechanism configured to limit stresses and strains along the length of the bridge. In a preferred embodiment, the reinforcement mechanism is fixed to a plurality of attachment points along the bridge, thereby preventing excessive elongation between any two attachment points. A resorbable material is preferably disposed within gaps along the length of the bridge to temporarily maintain the bridge in an elongated condition.

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 second loop-shaped support, which is configured to abut a second side of the heart valve opposite to said first side, whereby a portion of the valve tissue is trapped between the first and second supports. An outer boundary of the second support is greater than an outer boundary of the first support.

Abstract: Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: Methods and devices are provided for support of a body structure. The devices can be adjusted within the body of a patient in a minimally invasive or non-invasive manner such as by applying energy percutaneously or external to the patient's body. The energy may include, for example, acoustic energy, radio frequency energy, light energy and magnetic energy. Thus, as the body structure changes size and/or shape, the size and/or shape of the annuloplasty rings can be adjusted to provide continued reinforcement. In certain embodiments, the devices include an anterior portion, a posterior portion and two lateral portions corresponding to intersections of the anterior portion and the posterior portion. The devices have a first shape in a first configuration and a second shape in a second configuration and are configured to transform from the first configuration to the second configuration in response to an activation energy applied thereto.

Abstract: An apparatus including a tether, and an aptation device coupled to the tether at a position corresponding to a location to contact cusps of an atrioventricular valve during systole, wherein the tether and aptation device are suitable for percutaneous delivery to a patient. An apparatus including a support annulus comprising a length corresponding to a circumference of one of an interior portion of an atrium and an atrioventricular valve annulus; and an aptation device coupled to the support annulus corresponding to a location to contact cusps of an atrioventricular valve during at least one of systole when the support annulus is seated in one of an atrium and an atrioventricular valve annulus, wherein the support annulus and aptation device are suitable for percutaneous delivery to a patient. Also, a method of introducing an aptation device to contact cusps or leaflets of an atrioventricular valve.