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 a body member including a shape memory material, and an energy absorption enhancement material configured to absorb energy in response to an activation energy. The energy absorption enhancement material is in thermal communication with said shape memory material.

Abstract: An annuloplasty ring comprising an elongated curved member defining a ring-shape having an at rest size and shape to fit against the annulus of the mitral valve in a heart, the member having a substantial saddle shape wherein the annular height to width ratio is in the range of 5% to 50%.

Abstract: An implant is sized and configured to be positioned in a left atrium above the plane of a native mitral heart valve annulus having leaflets. The implant, when deployed, engages a wall of the left atrium above the plane of the native mitral valve annulus to interact with movement of the leaflets of the mitral heart valve to affect mitral heart valve function. The implant is deployed into the left atrium through an intravascular access path that extends from a right atrium through a septum and into a left atrium.

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.

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.

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: A method for helping improve operation of a heart valve includes implanting an apparatus at an annulus of a heart valve, such that one or more leaflets of the patient's heart valve the can move into and out of engagement with a portion of the implanted apparatus and thereby help control blood flow relative to the apparatus and heart valve.

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: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring.

Abstract: A mitral valve therapy device effects the condition of a mitral valve annulus of a heart. The device includes an elongated member dimensioned to be placed in the coronary sinus of the heart adjacent the mitral valve annulus. The elongated member is flexible when placed in the heart in a first orientation to position the device in the coronary sinus adjacent the mitral valve annulus and relatively inflexible when rotated into a second orientation after the device is positioned in the coronary sinus adjacent to the mitral valve annulus to substantially straighten and increase the radius of curvature of the mitral valve annulus.

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 a tubular member configured to be attached to or near a cardiac valve annulus. The tubular member includes a receptacle end and an insert end configured to couple with the receptacle end of the tubular member such that the tubular member substantially forms a shape of a ring. The insert end is configured to move with respect to the receptacle end to change a circumference of the ring.

Abstract: Tissue shaping methods and devices are provided. The devices can be adjusted within the body of a patient in a less invasive or non-invasive manner, such as by applying energy percutaneously or external to the patient's body. In one example, the device is positioned within the coronary sinus of the patient so as to effect changes in at least one dimension of the mitral valve annulus. The device may also advantageously include a shape memory material that is responsive to changes in temperature and/or exposure to a magnetic field. In one example, the shape memory material is responsive to energy, such as electromagnetic or acoustic energy, applied from an energy source located outside the coronary sinus. A material having enhanced absorption characteristics with respect to the desired heating energy may also be used to facilitate heating and adjustment of the tissue shaping device.

Abstract: A mitral annuloplasty ring with an inner core and an outer band located therearound is disclosed. The ring has an anterior region, a posterior region opposite the anterior region, and two side regions therebetween. A cross-sectional width dimension of the outer band is greater in the posterior region of the ring than in the anterior region. A cross-sectional width dimension of a semi-flexible core is thinner in the anterior and posterior regions than in the side regions so that the mitral ring is more rigid in the anterior-posterior direction. A tricuspid annuloplasty ring of the invention has an inner core and an outer band located therearound. The inner core has an anterior region separated across a gap from a septal region, and a posterior region. A cross-sectional width dimension of the outer band is greater in the septal region than either the anterior or posterior regions.

Abstract: In one embodiment, the present invention relates to a tissue shaping device adapted to be disposed in a vessel near a patient's heart to reshape the patient's heart. Such tissue shaping device can include an expandable proximal anchor; a proximal anchor lock adapted to lock the proximal anchor in an expanded configuration; an expandable distal anchor; a distal anchor lock adapted to lock the distal anchor in an expanded configuration; and a connector disposed between the proximal anchor and the distal anchor, the connector having a substantially non-circular cross-section.

Abstract: A device for modifying the shape of a mitral valve annulus. In one embodiment, the device includes a connector disposed between first and second anchors, the first and second anchors each adapted to be deployed in a coronary sinus adjacent the mitral valve annulus to anchor the device in the coronary sinus; and an actuation element adapted to receive a proximally or distally directed actuation force from an actuator and to transmit the actuation force to the first and second anchors simultaneously.

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: A transpericardial mitral annuloplasty system for the treatment of ischemic mitral regurgitation comprising an annuloplasty device comprising a body to be placed against the pericardium adjacent the mitral valve annulus opposite the anterolateral commissure of the annulus, and an attachment member being operable to tautly connect the body to the pericardium thereby causing an impression of the pericardium and the mitral valve annulus so that the annulus becomes remodeled.

Abstract: The invention is a device, and method for deploying same, configured for placement in a body lumen such as a coronary sinus, as may be desired to repair a mitral valve. The device includes a first anchor, a second anchor, and a bridge. The anchors are configured to delivered to a desired deployment site within the body lumen in a collapsed or contracted condition, and then be deployed by expanding the anchors into contact with the walls of the body lumen. One or more of the anchors may be configured to be radially collapsible after initial deployment in order to permit the anchor(s) to be repositioned in or removed from the body lumen. An anchor may be collapsible in response to a distal force applied to a portion of a proximal end thereof. A catheter for use with the implant is configured to deliver the implant to the site with the anchors in their respective collapsed configurations, and to release the anchors to permit them to expand into contact with the walls of the body lumen.

Abstract: A mitral annuloplasty ring that has a saddle shape with an upward bow in both an anterior segment and a posterior portion, with the upward bow being more pronounced in the anterior segment. The ring defines a closed ring body with a rounded isosceles triangular shape and the anterior segment along a long side. The posterior portion bulges outward to create a minor-major axis dimension ratio of between about 3.3:4 to 4:4. An inner ring body is made of a generally rigid material such as titanium that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart. The outward and upward posterior bow of the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, as seen with Barlow's syndrome for instance, in which the leaflets tend to be elongated or floppy.

Abstract: Methods of implanting an annuloplasty ring to correct maladies of the mitral annulus that not only reshapes the annulus but also reconfigures the adjacent left ventricular muscle wall. A posterior portion of the ring rises or bows upward from adjacent sides to pull the posterior aspect of the native annulus farther up than its original, healthy shape. In doing so, the ring also pulls the ventricular wall upward which helps mitigate some of the effects of congestive heart failure. Further, one or both of the posterior and anterior portions of the ring may also bow inward. The methods include securing the annuloplasty ring with the anterior portion against the annulus anterior aspect and the posterior portion against the annulus posterior aspect so that the ring posterior portion elevates, and may also pull radially inward, the annulus posterior aspect and corrects the mitral regurgitation.

Abstract: A mitral valve annulus reshaping device includes at least a portion that is formed of a biocompatible shape memory alloy SMA having a characteristic temperature, Af, that is preferably below body temperature. The device is constrained in an unstable martensite (UM) state while being introduced through a catheter that passes through the venous system and into the coronary sinus of the heart. The reshaping device is deployed adjacent to the mitral valve annulus of the heart as it is forced from the catheter. When released from the constraint of the catheter, the SMA of the device at least partially converts from the UM state to an austenitic state and attempts to change to a programmed shape that exerts a force on the adjacent tissue and modifies the shape of the annulus. The strain of the SMA can be varied when the device is within the coronary sinus.

Abstract: A device for treatment of mitral annulus dilatation comprises an elongate body having two states. In a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

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: An implantable device is provided for controlling the internal circumference of an anatomic orifice or lumen. The implantable device has an adjustable member configured to adjust the dimensions of the implantable device. The implantable device is configured to be coupled to a faster that provides for fastening of said implantable device to tissue around the anatomic orifice or lumen. An adjustment tool actuates the adjustable member and provides for adjustment before, during or after the anatomic orifice or lumen resumes near normal to normal physiologic function. The adjustment member of is positioned off plane relative to the implantable device to provide that the implantable device can be adjusted on a beating heart to cause leaflet coaptation. The adjustment member is positioned to enable attachment to and adjustment of the implantable device, and detachment from the implantable device and removal from the body under normal beating heart conditions.

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: A mitral annuloplasty ring that has an outward and an upward posterior bow. The ring defines a closed, modified oval shape with a minor-major axis dimension ratio of between about 3.3:4 to 4:4. The ring is made of a material that will substantially resist distortion when subjected to the stress imparted thereon when the ring is implanted in the mitral valve annulus of an operating human heart. As a result, the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, or Barlow's syndrome, in which the leaflets tend to be elongated or floppy.

Abstract: The present invention is a group of medical devices designed to improve heart valve function. The medical devices may be used individually, or in combination to supplement damaged valves, replace damaged valves, or improve damaged valves function. The medical devices include leaflet retainers, a neo-annulus, neo-leaflet, and a framework. In addition, the present invention is novel methods for surgically treating heart valves.

Abstract: A catheter based system for treating mitral valve regurgitation includes a reshaping device having a body and a plurality of movable anchoring barbs attached to the body of the device. The reshaping device can be made from a biocompatible material having suitable shape memory properties. The devices of the current invention can be self expandable, balloon expandable, or a combination self expandable and balloon expandable. One embodiment of the invention includes a method for attaching a reshaping device to the annulus of a mitral valve, moving the body of the device from a fully expanded configuration to a resting configuration, and thereby reshaping the mitral valve annulus.

Abstract: Delivery devices for placement of therapeutic devices relative a heart valve annulus of a beating heart that are delivered to the heart via minimally invasive surgical procedures and can be used in the heart during a therapeutic procedure that can be visualized in real time and be guided to specific locations within the heart. The systems and methods can be used to determine the exact location of the implantation delivery devices and therapeutic devices relative to a valve annulus and to determine that any therapeutic device is implanted in the correct location.

Abstract: The implant has an annularly bent base, whereby the imagined surface enclosed by the base is bent. Preferably the surface enclosed by the base is a symmetrical. It is particularly advantageous if the base is enclosed by a solid material and this is enclosed by a relatively soft material. This offers the possibility of designing fastening clips in the relatively solid material. Such implants are especially suited as heart valve rings.

Abstract: An assembly and method for effecting the condition of a mitral valve annulus of a heart includes a guide wire configured to be fed into the coronary sinus of the heart, and a mitral valve annulus therapy device configured to be slidingly received on the guide wire and advanced into the coronary sinus of the heart on the guide wire. A guide tube may further be employed for guiding the device into the coronary sinus. An introducer which may be employed for pushing the device into or pulling device out of the heart has a mechanism for releasably locking to the device. This enables substitution of the device if needed. Also, the crossover point of the circumflex artery and coronary sinus may be determined and avoided when the device is deployed.

Abstract: An implantable annuloplasty suture guide is intended to lie against at least a portion of an annulus surrounding a human heart. The implantable annuloplasty suture guide is made of an elongated ribbon of braided, heat setable material. The braided, heat-setable material is heat-set in a curved lengthwise configuration corresponding to at least a portion of the annulus of the human heart valve. A method of making an implantable annuloplasty suture guide configured to lie against at least a portion of an annulus defined by tissue surrounding a human heart. The method includes the steps of providing an elongate biocompatible ribbon comprising a braided, heat setable material. A fixture is provided, with the fixture comprising a heat conducting material defining an elongate cavity having a curved length-wise configuration corresponding to at least a portion of the annulus defined by the tissue surrounding the human heart.

Abstract: A method and apparatus is disclosed that allows a cardiac surgeon to temporarily and controllably dilate the aortic root using a thin walled spiral cylinder that is irreversibly dilated by an expansion apparatus. Following removal of the reversible expansive apparatus the irreversible dilation member temporarily remains in the expanded aortic root during aortic valve prosthesis placement with the irreversible dilation member at the level of the aortic annulus. Implantation sutures that had been previously placed are tied following the removal of the irreversible dilation member. The apparatus and method may be used to place a sub aortic stent for the treatment of sub aortic stenosis.

Abstract: A method and device for reducing mitral regurgitation. An elongated body is positioned in a coronary sinus of a patient in a vicinity of a heart mitral valve posterior leaflet. The body is adapted to straighten a natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet to move a posterior annulus anteriorly, which in turn moves the posterior leaflet anteriorly, thereby to improve leaflet coaptation.

Abstract: A medical device for treating a defective heart valve. The medical device comprises a delivery sheath and an implantable device moveably disposed within the delivery sheath. The implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket. Each of the distal expandable basket and proximal expandable basket is in a collapsed state during delivery and an expanded state after deployment. An actuator is releasably coupled to the implantable device. When coupled to the implantable device, the actuator can move the implantable device in a way to allow for positioning of the distal and proximal expandable baskets.

Abstract: A prosthesis for annuloplasty comprising a laminar or tubular element having a plurality of apertures along at least one portion. Preferably, the shape, dimensions, and arrangements of the apertures in this prosthesis are chosen in such a way as to give the prosthesis a differentiated flexibility in dependence on the location and direction of application of an external stress.

Abstract: A diagnostic device for determining the amount of change required in a coronary sinus to reduce valve regurgitation. The device includes a distal tube having a distal anchor at a distal end portion of the distal tube, a proximal tube having a proximal anchor at a distal end portion of the proximal tube, and an adjustor to move the distal tube relative to the proximal tube. The proximal tube and the distal tube together form a telescoping elongate body adapted to fit within the coronary sinus, and the device includes a scale to measure the movement of the distal anchor relative to the proximal anchor.

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: An apparatus helps improve operation of a heart valve. The apparatus includes an arcuate base portion having a central axis and a buttress extending from the base portion axially relative to the base portion. The buttress has a first surface and an opposite second surface. The first surface is dimensioned and configured to be engaged by a first leaflet of the heart valve when the apparatus is implanted in the heart valve. The second surface is dimensioned and configured to be engaged by a second leaflet of the heart valve when the apparatus is implanted in the heart valve. The buttress permits flow of blood adjacent both the first surface of the buttress and the second surface of the buttress when the first and second leaflets are not engaging the buttress.

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: A tissue connecting device is provided. The device comprise an elongate delivery device having a lumen, a proximal end, and a distal end. The distal end is configured to engage tissue and advance said device into tissue. At least one anchor deliverable through a lumen of the elongate delivery device. The distal end of the device may be designed to engage tissue upon rotation of the device about its longitudinal axis.

Abstract: A method for treatment of mitral annulus dilatation comprises reducing the circumference of the mitral valve annulus. The method further comprises inserting an elongate body into the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, fixing the position of the elongate body relative to the coronary sinus, and changing the shape of the elongate body in order to remodel the mitral valve annulus.

Abstract: A device for repairing a heart valve comprises an implantation instrument. The implantation instrument comprises a first support ring, and a second support ring connected to said first support ring to form a coiled configuration. The first support ring is configured to abut one side of the valve and the second support ring is configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween. The device further comprises an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly. The annuloplasty implant is connected to the implantation instrument for insertion to the annulus.

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: A valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.

Abstract: An annuloplasty system including an annuloplasty prosthesis and a holder for the prosthesis.

Abstract: A method of implanting a resilient self-molding annuloplasty ring including stretching it to an expanded diameter and attaching it to a heart valve annulus, then permitting the ring to contract to reduce the diameter of the annulus. The ring may be positioned on an insertion device that maintains the ring in its expanded diameter while attaching to the annulus. The resilient self molding annuloplasty ring which may be enlarged prior to implantation to facilitate implantation within a dilated or otherwise incompetent valve annulus having sufficient contractive force to render a valve competent. The self molding annuloplasty ring of the invention may further comprise integral attachment devices to aid in the implantation process.

Abstract: A device for treatment of mitral annulus dilatation comprises an elongate body having two states. In a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Abstract: The present invention relates to a minimally invasive method of performing annuloplasty. According to one aspect of the present invention, a method for performing annuloplasty includes accessing a left ventricle of a heart to provide a discrete plication element to the left ventricle, and engaging the plication element to tissue near a mitral valve of the heart. Engaging the plication element includes causing the plication element to gather a portion of the tissue to create a plication. In one embodiment, accessing the left ventricle of the heart to provide the plication element includes accessing the left ventricle of the heart using a catheter arrangement.