87 results about "Mitral valve repair" patented technology

A method for reducing mitral regurgitation comprising: providing a plication assembly comprising a first anchoring element, a second anchoring element, and a linkage construct connecting the first anchoring element to the second anchoring element; positioning the first anchoring element in the coronary sinus adjacent to the mitral annulus, and positioning the second anchoring element in another area of the mitral annulus so that the linkage construct extends across the opening of the mitral valve and holds the mitral valve in a reconfigured configuration so as to reduce mitral regurgitation. An apparatus for reducing mitral regurgitation comprising: a plication assembly comprising a first anchoring element, a second anchoring element, and a linkage construct connecting the first anchoring element to the second anchoring element; and a catheter adapted to deliver the first anchoring element to the coronary sinus.

A novel system for performing a heart valve annuloplasty. The system involves the use of a plication band. In one embodiment, the annulus of the valve is reduced by constriction of the plication band itself. More particularly, each plication band enters the tissue at two or more points which are spaced from one other by a distance which is dictated by the geometry of the plication band. Subsequent constriction of the plication band causes these points to move toward each other, thereby constricting the tissue trapped between these points and thus reducing the overall circumference of the valve annulus. In a second embodiment, the annulus of the valve is reduced by linking multiple plication bands to one other, using a linkage construct, and then using a shortening of the length of the linkage construct between each plication band so as to gather the tissue between each plication band, whereby to reduce the overall circumference of the valve annulus.

The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient.

The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. The stabilizing device may comprise a probe with vacuum ports and / or mechanical clamps disposed at the distal end to approximate the two pieces of tissue. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a toggle and suture arrangement deployed by a needle, wherein the needle enters the front side of the tissue and exits the blind side. In a second exemplary embodiment, the suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

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.

The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. The stabilizing device may comprise a probe with vacuum ports and / or mechanical clamps disposed at the distal end to approximate the two pieces of tissue. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a toggle and suture arrangement deployed by a needle, wherein the needle enters the front side of the tissue and exits the blind side. In a second exemplary embodiment, the suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

A system and method is provided for treating a mitral valve. The method preferably includes advancing a guide catheter to an ostium of the coronary sinus and advancing a delivery catheter containing a medical implant through the guide catheter and into the coronary sinus. The delivery catheter has an inner member on which the medical implant is held and an outer sheath which is retractable for deploying and releasing the medical implant. In one embodiment, the medical implant has proximal and distal anchors and a bridge containing resorbable material. The inner member may have a flexible sleeve for gripping and holding a portion of the outer sheath, thereby providing a releasable attachment mechanism. In another embodiment, the inner member may include an inflatable balloon having a tapered distal region which extends from the outer sheath for providing an atraumatic tip. The inflatable balloon may also be used to expand the medical implant and to grip the outer sheath.

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.

Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and / or rotating coupled to a proximal set of arms which are also pivotably and / or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

A method and apparatus directed to the repair of regurgitant mitral valves. Mitral valve regurgitation occurs due to miscoaptation of mitral valve leaflets. The mitral valve repair apparatus of the present invention is comprised of a tongue plate which is supported by a suture ring. The apparatus is inserted into the mitral valve orifice with the suture ring sutured to the mitral valve annulus placing the tongue plate between the two mitral valve leaflets. When the mitral valve opens, blood flows through the orifices of the apparatus. When the mitral valve closes, the two miscoaptated mitral valve leaflets cover the orifices on the apparatus and the tongue plate blocks the hole formed by leaflets and seals the leaky flow.

A mitral valve staple device treats mitral regurgitation of a heart. The device includes first and second leg portions, each leg portion terminating in a tissue piercing end, and a connection portion extending between the first and second leg portions. The connection portion has an initial stressed and distorted configuration to separate the first and second leg portion by a first distance when the tissue piercing ends pierce the mitral valve annulus and a final unstressed and undistorted configuration after the tissue piercing ends pierce the mitral valve annulus to separate the first and second leg portions by a second distance which is shorter than the first distance. The device is deployed within the heart transvenously through a catheter positioned in the coronary sinus adjacent the mitral valve annulus. A tool forces the mitral valve staple device through the wall of the catheter for deployment in the heart.

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of left atrial implants, mitral valve repair, or the like.

The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. The stabilizing device may comprise a probe with vacuum ports and / or mechanical clamps disposed at the distal end to approximate the two pieces of tissue. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a toggle and suture arrangement deployed by a needle, wherein the needle enters the front side of the tissue and exits the blind side. In a second exemplary embodiment, the suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

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.

A novel system for performing a heart valve annuloplasty. The system involves the use of a plication band. In one embodiment, the annulus of the valve is reduced by constriction of the plication band itself. More particularly, each plication band enters the tissue at two or more points which are spaced from one other by a distance which is dictated by the geometry of the plication band. Subsequent constriction of the plication band causes these points to move toward each other, thereby constricting the tissue trapped between these points and thus reducing the overall circumference of the valve annulus. In a second embodiment, the annulus of the valve is reduced by linking multiple plication bands to one other, using a linkage construct, and then using a shortening of the length of the linkage construct between each plication band so as to gather the tissue between each plication band, whereby to reduce the overall circumference of the valve annulus.

A method and apparatus for repairing the heart's mitral valve by using anatomic restoration without the need to stop the heart, use a heart-lung machine or making incisions on the heart. The method involves inserting a leaflet clamp through the heart's papillary muscle from which the leaflet has been disconnected, clamping the leaflet's free end and then puncturing the leaflet. One end of a suture is then passed through the hollow portion of the clamp, while the other end of the suture is maintained external to the heart. The clamp is then removed and the suture's two ends are fastened together with a securement ring / locking cap assembly to the heart wall exterior, thereby reconnecting the leaflet to the corresponding papillary muscle. The introduction of the clamp, puncturing of the leaflet, passage of the suture therethrough and removal of the clamp can be conducted a plurality of times before each suture's two ends are fastened to the securement ring / locking cap assembly.

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

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of left atrial implants, mitral valve repair, or the like.

Methods and devices for repairing a cardiac valve. A minimally invasive procedure includes creating an access in the apex region of the heart through which one or more instruments may be inserted. The device can implant artificial heart valve chordae tendineae into cardiac valve leaflet tissues to restore proper leaflet function and prevent reperfusion. The device punctures the apex of the heart and travels through the ventricle. The tip of the device rests on the defective valve and punctures the valve leaflet. A suture or a suture / guide wire combination is inserted, securing the top of the leaflet to the apex of the heart. A resilient element or shock absorber mechanism adjacent to the outside of the apex of the heart minimizes the linear travel of the device in response to the beating of the heart or opening / closing of the valve.

An apparatus for treating a mitral valve, comprising an elongate member having a spiral shape, the elongate member having a proximal end portion and a distal end portion, an expandable proximal anchor joined to the proximal end portion of the elongate body, and an expandable distal anchor joined to the distal end portion of the elongate body. The elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus.

Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and / or rotating coupled to a proximal set of arms which are also pivotably and / or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Methods and devices for repairing a cardiac valve. A minimally invasive procedure includes creating an access in the apex region of the heart through which one or more instruments may be inserted. The device can implant artificial heart valve chordae tendineae into cardiac valve leaflet tissues to restore proper leaflet function and prevent reperfusion. The device punctures the apex of the heart and travels through the ventricle. The tip of the device rests on the defective valve and punctures the valve leaflet. A suture or a suture / guide wire combination is inserted, securing the top of the leaflet to the apex of the heart. A resilient element or shock absorber mechanism adjacent to the outside of the apex of the heart minimizes the linear travel of the device in response to the beating of the heart or opening / closing of the valve.

An implant and method for repairing and / or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size upon implantation is used to approximate the amount of reduction in the size and the reshaping of the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and leakage therethrough. A prosthetic heart valve can be implanted in the coiled anchor to replace and further improve functionality of the valve. In some cases, the prosthetic valve can be implanted in a clipped valve, where the clip is detached from one of the native valve leaflets to provide space for the prosthetic valve to expand.

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.

A method and system for intraoperative guidance in an off-pump mitral valve repair procedure is disclosed. A plurality of patient-specific models of the mitral valve are generated, each from pre-operative image data obtained using a separate imaging modality. The pre-operative image data from the separate imaging modalities are fused into a common coordinate system by registering the plurality of patient-specific models. A model of the mitral valve is estimated in real-time in intraoperative image data using a fused physiological prior resulting from the registering of the plurality of patient-specific models.

The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient. In one embodiment, the method of repairing heart valve tissue includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with the therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and joining the first and second leaflets by reducing the distance between the first and second sutures.

A single catheter mitral valve repair device for stabilizing a tissue portion and selectively applying a tissue fastener thereto. The single catheter mitral valve repair device of the present invention includes an extendable engagement tip having at least one vacuum port formed thereon, at least one deployable fastener in communication with the engagement tip, and at least one actuator member in communication with the port. The deployable fastener is capable of controllably engaging and fastening a tissue segment located proximal to the engagement tip.

A noninvasive trans-catheter method and apparatus for remote suture placement can be used in a variety of inner cardiac applications. For example, a method of non-invasive transcatheter atrial septal defect repair comprises the steps of: advancing a positioning member along a catheter into the Atrial Septal Defect, wherein at least one suture deploying lumen is coupled to the positioning member with a piercing member within the suture deploying lumen; deploying the positioning member within the Atrial Septal Defect to align each suture deploying lumen with tissue adjacent the Atrial Septal Defect; and piercing the tissue adjacent the Atrial Septal Defect with the piercing member to secure a suture line through the tissue. A repair patch may be advanced along suture lines to repair the defect and secured into place with the suture lines. The apparatus is also applicable for left atrial appendage closure, mitral valve repair and pacemaker electrode placement.