223 results about "Annuloplasty rings" patented technology

A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a tool operable to implant such. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). The tissue anchors may be guided into precise position by an intravascularly or percutaneously deployed anchor guide frame of the tool and embedded in an annulus of the orifice. Constriction of the orifice may be accomplished via a variety of structures, for example by cinching a flexible cable or via a anchored annuloplasty ring, the cable or ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arch, arcuate or annular configuration. Such may approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve, to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to eliminate mitral regurgitation.

Methods for reconfiguring an atrioventricular heart valve that may use systems comprising a partial or complete annuloplasty rings proportioned to reconfigure a heart valve that has become in some way incompetent, a pair of trigonal sutures or implantable anchors, and a plurality of staples which may have pairs of legs that are sized and shaped for association with the ring at spaced locations along its length. These systems permit relative axial movement between the staples and the ring, whereby a patient's heart valve can be reconfigured in a manner that does not deter subtle shifting of the native valve components. Shape-memory alloy material staples may have legs with free ends that interlock following implantation. Annuloplasty rings may be complete or partial and may be fenestrated. One alternative method routes a flexible wire, preferably of shape-memory material, through the bights of pre-implanted staples. Other alternative systems use linkers of shape-memory material having hooked ends to interengage with staples or other implanted supports which, following implantation, decrease in effective length and pull the staples or other supports toward one another so as to create desired curvature of the reconfigured valve. These linkers may be separate from the supports or may be integral with them and may have a variety of shapes and forms. Various of these systems may be implanted non-invasively using a delivery catheter.

A device comprising a reference ring that may be temporarily disposed in abutment with the inferior perimeter surface of a heart valve to aid non-optical visualization of the valve annulus. The reference ring is elastically transformable between a straight delivery configuration and a generally circular or helical deployment configuration. The reference ring may include an inflatable portion that can be temporarily expanded on the inferior side of the valve annulus to deform the valve annulus into a temporary ledge or shelf for apposition with an annuloplasty ring. A system comprising a delivery catheter including a lumen with an exit port, the reference ring being slidably positionable within the lumen and being extendable from the exit port.

A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath, and the ring body may be formed of a plurality of concentric ring elements. The ring is semi-rigid and the posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. The ring elements may be bands of semi-rigid material. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

The present invention is directed to methods and devices for repairing a cardiac valve. Generally, the methods involve a minimally invasive procedure that includes creating an access in the apex region of the heart through which one or more instruments may be inserted so as to repair a cardiac valve, for instance, a mitral or tricuspid valve. Accordingly, the methods are useful for performing a variety of procedures to effectuate a repair. For instance, in one embodiment, the methods are useful for repairing a cardiac valve by implanting one or more artificial heart valve chordae tendinae into one or more cardiac valve leaflet tissues so as to restore the proper leaflet function and thereby prevent reperfusion. In another embodiment, the methods are useful for repairing a cardiac valve by resecting a portion of one or more cardiac valve leaflets and implanting one or more sutures into the resected valve tissues, which may also include the implantation of an annuloplasty ring. In an additional embodiment, the methods are useful for performing an edge to edge bow-tie repair (e.g., an Alfieri repair) on cardiac valve tissues. Devices for performing the methods of the invention are also provided.

A remodeling mitral annuloplasty ring with a reduced anterior-to-posterior dimension to restore coaptation between the mitral leaflets in mitral valve insufficiency (IMVI). The ring has a generally oval shaped body with a major axis perpendicular to a minor axis, both perpendicular to a blood flow axis. An anterior section lies between anteriolateral and posteriomedial trigones, while a posterior section defines the remaining ring body and is divided into P1, P2, and P3 segments corresponding to the three scallops of the same nomenclature in the posterior leaflet of the mitral valve. The anterior-to-posterior dimension of the ring body is reduced from conventional rings; such as by providing, in atrial plan view, a pulled-in P3 segment. Viewed another way, the convexity of the P3 segment is less pronounced than the convexity of the P1 segment. In addition, the ring body may have a downwardly deflected portion in the posterior section, preferably within the P2 and P3 segments. The downwardly deflected portion may have an apex which is the lowest elevation of the ring body and may be offset with respect to the center of the downwardly deflected portion toward the P1 segment. A sewing cuff may have an enlarged radial dimension of between 5-10 cm, or only a portion of the sewing cuff may be enlarged.

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.

Apparatus is provided that is configured to be implanted in a body of a subject, comprising an implant structure having first and second portions thereof, a spool coupled to the implant structure in a vicinity of the first portion thereof, and a flexible member coupled at a first end thereof to the spool, and not attached at a second end thereof to the spool. The flexible member, in response to rotation of the spool in a first direction thereof, is configured to be wound around the spool, and, responsively, to pull the second end of the flexible member toward the first end of the implant structure, and responsively to draw the first and second portions of the implant structure toward each other. Other embodiments are also described.

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. The template may have an outwardly-facing groove to receive and retain the ring.

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

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow body member including a plurality of regions. Adjacent regions cooperate with one another to change the body member from an elongate insertion geometry to an annular operable geometry. Adjacent regions are coupled by a biasing element or a stepped connector to allow expansion to an expanded state and contraction to a contracted state in the annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the body member and having a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. An angled ring closure lock allows coupling of the ends of an annuloplasty ring at an apex of a D-shape annular operable geometry.

Implantable devices and methods for the repair of a defective cardiac valve are provided. The implantable devices include an annuloplasty ring and a restraining or support structure or mechanism. The annuloplasty ring functions to reestablish the normal size and shape of the annulus bringing the leaflet in proximity to each other. The restraining structure functions to restrain the abnormal motion of at least a portion of the valve being repaired. The restraining structure may include at least one restraining member across the interior of the circumference of the ring in a configuration consisting of a primary member to which secondary members are attached or one where all members traverse the ring. Kits for using the devices and practicing the methods of the invention are also provided.

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

An apparatus for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve includes a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve. The apparatus also includes an elongate flexible body having proximal and distal end portions and being insertable into the first annuloplasty ring. The elongate flexible body has an adjustable mechanism for selectively adjusting the elongate flexible body from a first relaxed configuration to a second tensioned configuration. The first annuloplasty ring is adaptable to obtain a second smaller diameter and to cause the annulus of the cardiac valve to be modified and reduce regurgitation of blood flow through the cardiac valve when the elongate flexible body obtains the second tensioned configuration.

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the outer hollow member. The internal anchor member includes a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. The internal anchor member is configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

Apparatus, systems, and methods are provided for percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer tube, an inner body member, and an anchor deployment system. The outer tube includes a plurality of windows and has an axis along its length. The internal body member includes a plurality of anchors formed perpendicular to the axis. The anchor deployment system selectively rotates the internal body member with respect to the axis of the outer tube. The rotation deploys the plurality of anchors through the plurality of windows.

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the outer hollow member. The internal anchor member includes a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. The internal anchor member is configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

Apparatus is provided that includes an annuloplasty system for use on a subject. The system includes an annuloplasty ring, which includes a sleeve having a lumen, and at least one anchor, shaped so as to define a coupling head and a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis. The system further includes an anchor deployment manipulator, configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the tissue coupling element from a distal end of the deployment manipulator through a wall of the sleeve into the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to a central longitudinal axis through the distal end of the deployment manipulator.

An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

A heart valve sewing prosthesis including an intrinsically conductive polymer. The invention includes annuloplasty rings and bands, and sewing rings or cuffs for prosthetic heart valves. Some annuloplasty rings and sewing rings include fabric that is coated with an intrinsically conductive polymer. The coating can be formed over individual filaments or fibers, or on the fabric surface as a surface layer. One intrinsically conductive polymer is polypyrrole. The intrinsically conductive polymer can be doped to facilitate the intrinsic conductivity. Some devices have a polypyrrole surface layer doped with dialkyl-napthalene sulfonate. The intrinsically conductive polymer can be deposited on a fabric using in-situ polymerization of monomeric or oligomeric species, together with a dopant. Animal studies using implanted annuloplasty rings having an intrinsically conductive polymer coating have demonstrated a substantial reduction in pannus formation and inflammatory response.

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 first body member including a first shape memory material configured to transform the annuloplasty ring from a first configuration having a first size of a dimension to a second configuration having a second size of the dimension. The second size is less than said first size in septal lateral distance. The devices also include a second body member including a second shape memory material configured to transform the annuloplasty ring from the second configuration to a third configuration having a third size of the dimension, wherein the second size is less than the third size in septal lateral distance.

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.

A device, kit and method may include or employ an implantable device (e.g., annuloplasty implant) and a plurality of tissue anchors. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). Each of the tissue anchors may be guided into precise position by an intravascularly or percutaneously techniques. Constriction of the orifice may be accomplished via a variety of structures, for example an articulated annuloplasty ring, the ring attached to the tissue anchors. The annuloplasty ring may be delivered in an unanchored, generally elongated configuration, and implanted in an anchored generally arched, arcuate or annular configuration. Such may approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve, to move the posterior leaflet anteriorly and the anterior leaflet posteriorly, thereby improving leaflet coaptation to reduce mitral regurgitation.

An apparatus for repairing a cardiac valve includes an annuloplasty ring having an expandable support member with oppositely disposed proximal and distal end portions and a main body portion between the end portions. The proximal end portion includes a plurality of wing members extending from the main body portion. Each of the wing members includes at least one hook member for embedding into a cardiac wall and a valve annulus to secure the annuloplasty ring therein. The apparatus also includes an energy delivery mechanism for selectively contracting the annuloplasty ring to restrict the valve annulus and correct valvular insufficiency. The energy delivery mechanism includes a detachable electrical lead having distal and proximal end portions. The distal end portion has a securing member for operably attaching the distal end portion to a portion of the expandable support member. The proximal end portion is operably connected to an energy delivery source.

A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath formed of a plurality of concentric ring elements or bands. The posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

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.