Patent Grant
9132009
Embodiments of the present invention relate in general to valve replacement. More specifically, embodiments of the present invention relate to prosthetic valves for replacement of an atrioventricular valve.
Ischemic heart disease causes regurgitation of a heart valve by the combination of ischemic dysfunction of the papillary muscles, and the dilatation of the ventricle that is present in ischemic heart disease, with the subsequent displacement of the papillary muscles and the dilatation of the valve annulus.
Dilation of the annulus of the valve prevents the valve leaflets from fully coapting when the valve is closed. Regurgitation of blood from the ventricle into the atrium results in increased total stroke volume and decreased cardiac output, and ultimate weakening of the ventricle secondary to a volume overload and a pressure overload of the atrium.
PCT Publication WO 09/033,469 to Lutter et al. describes a heart valve stent having a section equipped to receive a heart valve implant and a plurality of proximally disposed anchoring elements, characterized by a plurality of anchoring threads, which with the one end thereof are fastened to the stent, and further having a brace fastening the anchoring threads with the other end thereof to the distal chamber wall to provide tension between the heart chamber wall and the proximally anchored anchoring elements.
U.S. Pat. No. 7,018,406 to Seguin et al. describes a prosthetic valve assembly for use in replacing a deficient native valve comprising a replacement valve supported on an expandable valve support. If desired, one or more anchors may be used. The valve support, which is described as entirely supporting the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.
US Patent Application Publication 2007/0213813 to Von Segesser et al. describes stent-valves (e.g., single-stent-valves and double-stent-valves), associated methods and systems for their delivery via minimally-invasive surgery, and guide-wire compatible closure devices for sealing access orifices are provided.
US Patent Application Publication 2008/0208332 to Lamphere et al. describes valve prostheses that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via trans-catheter techniques, and may be positioned/repositioned until proper alignment and positioning is achieved. The valve prosthesis may include a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring, each of the positioning elements defining a first tissue engaging region and a second tissue engaging region spaced from the first tissue engaging region. The positioning elements are adapted to substantially completely invert by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed for engaging tissue. The valve prosthesis may also include a valve skirt mounted with respect to the resilient ring.
U.S. Pat. No. 6,458,153 to Bailey et al. describes prosthetic cardiac and venous valves and a single catheter device and minimally invasive techniques for percutaneous and transluminal valvuloplasty and prosthetic valve implantation.
U.S. Pat. No. 6,767,362 to Schreck describes expandable heart valves for minimally invasive valve replacement surgeries. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves may be implanted using a balloon catheter. Preferably, the leaflets of the heart valves are secured to the commissure regions of the expandable stents using a clamping arrangement to reduce stress.
U.S. Pat. No. 7,481,838 to Carpentier et al. describes a highly flexible tissue-type heart valve having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween.
US Patent Application Publication 2009/0210052 to Forster et al. describes systems and methods for operation of a prosthetic valve support structure having additional reinforcement coupled with panels. Multiple support members are distributed across the inner surface of the valve support structure at regular intervals. Each support member can include a looped portion to act as a hinge. Each looped portion is in a location coincidental with the interlace between adjacent panels.
The following references may be of interest:
U.S. Pat. No. 4,261,342 to Aranguren Duo
U.S. Pat. No. 6,074,417 to Peredo
U.S. Pat. No. 6,332,893 to Mortier et al.
U.S. Pat. No. 7,101,395 to Tremulis et al.
U.S. Pat. No. 7,404,824 to Webler et al.
US Patent Application Publication 2003/0105519 to Fasol et al.
US Patent Application Publication 2005/0004668 to Aklog et al.
US Patent Application Publication 2005/0137688 to Salahieh et al.
US Patent Application Publication 2006/0253191 to Salahieh et al. doc
US Patent Application Publication 2008/0243245 to Thambar et al.
US Patent Application Publication 2008/0262609 to Gross et al.
US Patent Application Publication 2009/0177278 to Spence
PCT Publication WO 06/054930 to Antonsson et al.
PCT Publication WO 08/013,915 to Quadri
PCT Publication WO 09/053,497 to Essinger et al.
Langer F et al., “RING plus STRING: Papillary muscle repositioning as an adjunctive repair technique for ischemic mitral regurgitation,” J Thorac Cardiovasc Surg 133:247-9 (2007)
Langer F et al., “RING+STRING: Successful repair technique for ischemic mitral regurgitation with severe leaflet tethering,” Circulation 120[suppl 1]:S85-S91 (2009)
In some embodiments of the present invention, one or more guide members (e.g., wires, sutures, or strings) is configured to be anchored to respective commissures of a native atrioventricular valve of a patient, and each guide member facilitates the advancement therealong of respective commissural anchors. The commissural anchors are shaped so as to define a plurality of barbs or prongs which are expandable to restrict proximal movement of the anchors following their deployment. The guide members facilitate advancement of a collapsible prosthetic valve support (e.g., a skirt) which serves as a base for and receives a collapsible prosthetic mitral valve which is subsequently coupled to the support. The support comprises a proximal annular element, or ring, and a distal cylindrical element. The cylindrical element is configured to push aside and press against the native leaflets of the native valve, and the proximal annular element is shaped so as to define one or more holes for sliding the valve support along the one or more guide members. The proximal annular element is configured to be positioned along the annulus of the native valve.
The collapsible prosthetic valve is configured for implantation in and/or at least partial replacement (e.g., full replacement) of the native atrioventricular valve of the patient, such as a native mitral valve or a native tricuspid valve. The valve support and the prosthetic valve are configured to assume collapsed states for minimally-invasive delivery to the diseased native valve, such as by percutaneous or transluminal delivery using one or more catheters. For some applications, the valve support and the prosthetic valve are implanted during an open-heart procedure.
The prosthetic valve support is shaped so as to define a downstream skirt. The downstream skirt is configured to be placed at native valve, such that the downstream skirt passes through the orifice of the native valve and extends toward, and, typically partially into, a ventricle. The downstream skirt typically additionally pushes aside and presses against the native leaflets of the native valve, which are left in place during and after implantation of the prosthetic valve support and/or the prosthetic valve.
The proximal annular element has upper and lower surfaces. For some applications of the present invention, one or more, e.g., a plurality of tissue anchors are coupled to the lower surface and facilitate anchoring of the proximal annular element to the annulus of the native valve. For some applications, the one or more anchors comprise at least first and second commissural anchors that are configured to be implanted at or in the vicinity of the commissures of the native valve.
The cylindrical element of the valve support has first and second ends and a cylindrical body disposed between the first and second ends. The first end of the cylindrical element is coupled to the annular element while the second end defines a free end of the cylindrical element. For some applications of the present invention, the cylindrical element of the valve support is invertible such that (1) during a first period, the second end and the cylindrical body of the cylindrical element are disposed above the annular element (e.g., in the atrium of the heart), and (2) during a second period, the second end and the cylindrical body of the cylindrical element are disposed below the annular element (e.g., in the ventricle of the heart).
There is therefore provided, in accordance with some applications of the present invention, apparatus, including:
one or more valve support guide members configured to be delivered to one or more commissures of a native atrioventricular valve of a patient;
one or more valve support anchors configured to be anchored to the one or more commissures of the native valve;
a prosthetic valve support advanceable toward the native valve along the one or more valve support guide members and anchored to the native valve at least the one or more commissures; and
a prosthetic valve configured to be coupled to the valve support.
In some applications of the present invention, the valve support is collapsible for transcatheter delivery and expandable to contact the native atrioventricular valve.
In some applications of the present invention, the one or more valve support anchors are configured to be anchored to the one or more commissures from ventricular surfaces thereof.
In some applications of the present invention, the one or more valve support guide members includes one valve support guide member that is looped through first and second commissures of the atrioventricular valve in a manner in which a looped portion of the valve support guide member is disposed in a ventricle of the patient and first and second free ends of the valve support guide member are accessible from a site outside a body of the patient.
In some applications of the present invention, the one or more valve support anchors includes first and second tissue anchors, the first and second tissue anchors being configured to be anchored to respective first and second commissures of the atrioventricular valve of the patient.
In some applications of the present invention:
the one or more valve support anchors each include one or more radially-expandable prongs, and
the one or more prongs are disposed within a sheath in a compressed state prior to the anchoring, and exposed from within the sheath in order to expand and facilitate anchoring of the valve support anchor to the respective commissures.
In some applications of the present invention, the prosthetic valve includes two or more prosthetic leaflets.
In some applications of the present invention, the native atrioventricular valve includes a mitral valve, and the prosthetic valve includes three prosthetic leaflets.
In some applications of the present invention, the valve support guide members are removable from the patient following the anchoring of the prosthetic valve support at the atrioventricular valve.
In some applications of the present invention, the valve support is shaped so as to define a distal portion which is configured to push aside, at least in part, native leaflets of the valve of the patient.
In some applications of the present invention, the one or more valve support anchors are advanceable along the one or more valve support guide members.
In some applications of the present invention, the valve support is shaped so as to define one or more holes, the one or more holes being configured to facilitate slidable passage therethrough of a respective one of the one or more valve support Guide members.
In some applications of the present invention, the prosthetic valve is shaped so as to define one or more snares configured to ensnare one or more native leaflets of the native valve of the patient.
In some applications of the present invention, the one or more valve support anchors includes one or more ventricular anchors, and the apparatus further includes one or more atrial anchors, each atrial anchor being configured to be advanced toward an atrial surface of the valve support and anchor in place the valve support in a vicinity of a respective one of the ventricular anchors.
In some applications of the present invention, the apparatus includes one or more delivery lumens, and:
each one of the one or more valve support anchors is removably coupled to a distal end of a respective delivery lumen,
the delivery lumen is configured to facilitate advancement of the one or more anchors along the one or more guide members, and
the delivery lumen is decoupled from the anchor following the anchoring of the anchor to the one or more commissures.
In some applications of the present invention, the one or more valve support guide members are removable from the body of the patient following the advancement of the one or more anchors along the one or more guide members.
In some applications of the present invention:
the valve support is shaped so as to define one or more holes,
the one or more holes are configured to facilitate slidable passage therethrough of a respective one of the one or more delivery lumens, and
the one or more delivery lumens are decoupleable from the respective valve support anchor following the anchoring of the valve support to at least the one or more commissures.
In some applications of the present invention, the one or more delivery lumens are removable from the body of the patient following the anchoring of the valve support to at least the one or more commissures.
In some applications of the present invention, the valve support includes an annular element and a generally cylindrical element coupled to the annular element, the generally cylindrical element being configured to push aside native leaflets of the native valve, the cylindrical element has first and second ends and a cylindrical body that is disposed between the first and second ends.
In some applications of the present invention, the apparatus includes one or more annular element tissue anchors, the annular element has an upper surface and a lower surface, and the lower surface is coupled to the one or more annular element tissue anchors, the one or more annular element tissue anchors being configured to puncture tissue of a native annulus of the native valve of the patient.
In some applications of the present invention, one or more annular element tissue anchors includes a plurality of annular element tissue anchors positioned around the lower surface of the annular element.
In some applications of the present invention, the one or more annular element tissue anchors includes a first commissural anchor configured to puncture tissue of the native valve at a first commissure thereof, and a second commissural anchor configured to puncture tissue of the native valve at a second commissure thereof.
In some applications of the present invention, each anchor of the one or more annular element tissue anchors includes a distal pointed tip and one or more radially-expandable prongs, the prongs being configured to expand and facilitate anchoring of the anchor and restrict proximal motion of the annular element tissue anchor.
In some applications of the present invention, the apparatus includes one or more prosthetic valve guide members reversibly couplable to the cylindrical element in a vicinity of the second end of the cylindrical element, the prosthetic valve guide members being configured to facilitate advancement of the prosthetic valve therealong and toward the valve support.
In some applications of the present invention:
In some applications of the present invention:
during the first period, the second end of the cylindrical element is disposed in an atrium of a heart of the patient and the annular element is positioned along an annulus of the native valve,
the prosthetic valve is advanceable along the one or more prosthetic valve guide members into a ventricle of the heart of the patient, and
in response to advancement of the prosthetic valve into the ventricle, the one or more prosthetic valve guide members are pulled into the ventricle and pull the second end and the body of the cylindrical element into the ventricle to invert the cylindrical element.
There is further provided, in accordance with some applications of the present invention, a method, including:
advancing one or more valve support guide members toward one or more commissures of a native atrioventricular valve of a patient;
advancing along the one or more valve support guide members one or more valve support tissue anchors toward the one or more commissures;
anchoring the one or more valve support tissue anchors to the one or more commissures;
anchoring a prosthetic valve support at the native atrioventricular valve by anchoring the prosthetic valve support at least the one or more commissures; and
coupling a prosthetic valve to the prosthetic valve support.
In some applications of the present invention, the method includes removing the one or more valve support guide members following the anchoring of the prosthetic valve support at the native atrioventricular valve.
In some applications of the present invention, advancing the one or more valve support guide members toward the one or more commissures includes advancing one guide member and looping the one guide member through first and second commissures of the native atrioventricular valve in a manner in which a looped portion of the guide member is disposed in a ventricle of the patient and first and second free ends of the guide member are accessible from a site outside a body of the patient.
In some applications of the present invention, anchoring the one or more valve support anchors includes anchoring the one or more valve support anchors to ventricular surface of the respective commissures of the native valve.
In sonic applications of the present invention, anchoring the one or more valve support anchors includes anchoring first and second tissue anchors to respective first and second commissures of the native valve.
In some applications of the present invention:
advancing along the one or more valve support guide members the one or more valve support tissue anchors includes advancing the one or more valve support tissue anchors within a sheath, and
anchoring the one or more valve support tissue anchors includes exposing the one or more valve support anchors from within the sheath and facilitating radial expansion of one or more radially-expandable prongs of the one or more anchors.
In some applications of the present invention, coupling the prosthetic valve to the prosthetic valve support includes coupling a prosthetic valve having two or more leaflets.
In some applications of the present invention, the native atrioventricular valve includes a mitral valve of the patient, and coupling the prosthetic valve to the prosthetic valve support includes coupling a prosthetic valve having three leaflets.
In some applications of the present invention, anchoring the prosthetic valve support includes pushing aside, at least in part, native leaflets of the valve of the patient by at least a portion of the support.
In some applications of the present invention, the prosthetic valve support is coupled to one or more annulus tissue anchors, and anchoring the prosthetic valve support includes pushing the one or more annulus tissue anchors into tissue of an annulus of the native valve.
In some applications of the present invention, coupling the prosthetic valve to the prosthetic valve support includes ensnaring one or more native leaflets of the native valve of the patient by a portion of the prosthetic valve.
In sonic applications of the present invention, the one or more valve support anchors includes one or more ventricular anchors, and the method further includes advancing one or more atrial anchors to an atrial surface of the valve support, and anchoring in place the valve support in a vicinity of a respective one of the ventricular anchors.
In some applications of the present invention, the method includes advancing the valve support along the one or more valve support guide members prior to the anchoring of the valve support.
In some applications of the present invention, the valve support is shaped so as to define one or more holes, and advancing the valve support along the one or more valve support guide members includes threading the one or more valve support guide members through the one or more holes of the valve support and sliding the valve support along the one or more guide members.
In some applications of the present invention, the method includes removing the one or more valve support guide members from a body of the patient following the anchoring of the valve support.
In some applications of the present invention,
the valve support includes:
anchoring of the valve support, including anchoring the valve support in a manner in which:
In some applications of the present invention, the method includes, following the anchoring, inverting the cylindrical element to pull the second end of the cylindrical element below the annular element and into a ventricle of the heart, in a manner in which the body of the cylindrical element is disposed below the annular element and pushes aside one or more native leaflets of the valve of the patient.
In some applications of the present invention:
inverting the cylindrical element includes advancing the prosthetic valve along one or more prosthetic valve guide members reversibly coupled to the cylindrical element in a vicinity of the second end thereof,
advancing the prosthetic valve includes advancing the prosthetic valve into the ventricle to pull the prosthetic valve guide members and the second end of the cylindrical element into the ventricle, and
the method further includes following the advancing of the prosthetic valve into the ventricle, pulling proximally the prosthetic valve such that a proximal portion of the valve contacts the valve support.
In some applications of the present invention, pulling the prosthetic valve proximally includes ensnaring the one or more leaflets of the valve by a portion of the prosthetic valve.
In some applications of the present invention, advancing the one or more valve support anchors includes:
providing a respective delivery lumen coupled at a distal end thereof to each one of the one or more anchors,
advancing each delivery lumen along a respective one of the one or more valve support guide members,
facilitating anchoring of each one of the one or more anchors to the one or more commissures by the respective delivery lumen, and
decoupling the delivery lumen from each one of the one or more valve support anchors following the anchoring of the one or more valve support anchors.
In some applications of the present invention, the method includes removing the one or more valve support guide members from a body of the patient following the anchoring of each one of the one or more valve support anchors to the one or more commissures.
In some applications of the present invention, the method includes advancing the prosthetic valve support along the one or more delivery lumens prior to the anchoring the support at the native atrioventricular valve.
In some applications of the present invention, the valve support is shaped so as to define one or more holes, and advancing the valve support along the one or more delivery lumens includes threading the one or more delivery lumens through the one or more holes of the valve support and sliding the valve support along the one or more delivery lumens.
In some applications of the present invention, the method includes removing the one or more delivery lumens from a body of the patient following the anchoring the support at the atrioventricular valve.
There is additionally provided, in accordance with some applications of the present invention, apparatus including a valve support for receiving a prosthetic valve, the valve support including:
an annular element configured to be positioned along a native annulus of a native atrioventricular valve of a patient; and
a flexible generally cylindrical element configured to be positioned in the native atrioventricular valve of the patient and to push aside native leaflets of the native valve, the cylindrical element having first and second ends and a cylindrical body that is disposed between the first and second ends, and:
In some applications of the present invention, the cylindrical element includes a flexible wireframe covered by a fabric.
In some applications of the present invention, the valve support is collapsible for transcatheter delivery and expandable to contact the native atrioventricular valve.
In some applications of the present invention, the annular element has an upper surface and a lower surface, the lower surface is coupled to one or more annular element tissue anchors configured to puncture tissue of the native annulus of the patient.
In some applications of the present invention, the one or more annular element tissue anchors includes a plurality of annular element tissue anchors positioned around the lower surface of the annular element.
In some applications of the present invention, the one or more annular element tissue anchors includes a first commissural annular element tissue anchor configured to puncture tissue of the native valve at a first commissure thereof, and a second commissural annular element tissue anchor configured to puncture tissue of the native valve at a second commissure thereof.
In some applications of the present invention, each anchor of the one or more annular element tissue anchors includes a distal pointed tip and one or more radially-expandable prongs, the prongs being configured to expand and facilitate anchoring of the anchor and restrict proximal motion of the annular element tissue anchor.
In some applications of the present invention, the apparatus includes one or more valve support guide members configured to be delivered to one or more commissures of the native atrioventricular valve of the patient, the one or more valve support guide members are configured to facilitate advancement of the valve support toward the native valve.
In some applications of the present invention, the valve support is shaped so as to define one or more holes, the one or more holes configured to facilitate slidable passage therethrough of a respective one of the one or more valve support guide members.
In some applications of the present invention, the one or more valve support guide members includes one valve support guide member that is looped through first and second commissures of the atrioventricular valve in a manner in which a looped portion of the valve support guide member is disposed in a ventricle of the patient and first and second free ends of the valve support guide member are accessible from a site outside a body of the patient.
In some applications of the present invention, the apparatus includes one or more valve support tissue anchors configured to be advanceable along the one or more valve support guide members and anchored to the one or more commissures of the valve.
In some applications of the present invention, the one or more valve support anchors includes one or more ventricular anchors, and the apparatus further includes one or more atrial anchors, each atrial anchor being configured to be advanced toward an atrial surface of the valve support and anchor in place the valve support in a vicinity of a respective one of the ventricular anchors.
In some applications of the present invention, the valve support guide members are removable from the patient following the anchoring of the valve support at the atrioventricular valve.
In some applications of the present invention, the one or more valve support anchors are configured to be anchored to the one or more commissures from ventricular surfaces thereof prior to advancement of the valve support.
In some applications of the present invention, the one or more valve support tissue anchors includes first and second valve support tissue anchors, the first and second valve support tissue anchors being configured to be anchored to respective first and second commissures of the atrioventricular valve of the patient.
In some applications of the present invention:
the one or more valve support tissue anchors each include one or more radially-expandable prongs, and
the one or more prongs are disposed within a sheath in a compressed state prior to the anchoring and exposed from within the sheath in order to expand and facilitate anchoring of the anchor to the respective commissures.
In some applications of the present invention, the apparatus includes one or more prosthetic valve guide members reversibly couplable to the cylindrical element in a vicinity of the second end of the cylindrical element, the prosthetic valve guide members being configured to facilitate advancement of the prosthetic valve therealong and toward the valve support.
In some applications of the present invention, the apparatus includes the prosthetic valve, the prosthetic valve is couplable to the valve support.
In some applications of the present invention:
during the first period, the second end of the cylindrical element is disposed in an atrium of a heart of the patient and the annular element is positioned along an annulus of the native valve,
the prosthetic valve is advanceable along the one or more prosthetic valve guide members into a ventricle of the heart of the patient, and
in response to advancement of the prosthetic valve into the ventricle, the one or more prosthetic valve guide members are pulled into the ventricle and pull the second end of the cylindrical element into the ventricle to invert the cylindrical element.
In some applications of the present invention, the prosthetic valve is collapsible for transcatheter delivery and expandable when exposed from within a delivery catheter.
In some applications of the present invention, the prosthetic valve includes two or more prosthetic leaflets.
In some applications of the present invention, the native atrioventricular valve includes a mitral valve, and the prosthetic valve includes three prosthetic leaflets.
In some applications of the present invention, the prosthetic valve guide members are removable from the patient following the anchoring of the prosthetic valve at the atrioventricular valve.
In some applications of the present invention, the prosthetic valve is shaped so as to define one or more snares configured to ensnare one or more native leaflets of the native valve of the patient.
There is yet additionally provided, in accordance with some applications of the present invention, a method, including:
advancing toward a native atrioventricular valve of a heart of a patient, a valve support including:
anchoring the annular element to an annulus of the native atrioventricular valve, following the anchoring, the second end of the cylindrical element is disposed above the annular element in an atrium of the heart, in a manner in which the body of the cylindrical element is disposed above the annular element; and
following the anchoring, inverting the cylindrical element to pull the second end of the cylindrical element below the annular element and into a ventricle of the heart, in a manner in which the body of the cylindrical element is disposed below the annular element and pushes aside one or more native leaflets of the valve of the patient.
In some applications of the present invention, anchoring the annular element to the annulus of the native atrioventricular valve includes:
advancing one or more valve support anchors that are distinct from the valve support toward one or more commissures of the heart, and
anchoring the annular element to the annulus using the one or more positioning anchors.
In some applications of the present invention, the annular element is coupled to one or more annular element tissue anchors, and anchoring the annular element includes pushing the one or more annular element tissue anchors into tissue of the annulus.
In some applications of the present invention:
inverting the cylindrical element includes advancing a prosthetic valve along one or more valve guide members reversibly coupled to the cylindrical element in a vicinity of the second end thereof,
advancing the prosthetic valve includes advancing the prosthetic valve into the ventricle to pull the guide members and the second end of the cylindrical element into the ventricle, and
the method further includes following the advancing of the prosthetic valve into the ventricle, pulling proximally the prosthetic valve such that a proximal portion of the valve contacts the valve support.
In some applications of the present invention, pulling the prosthetic valve proximally includes ensnaring the one or more leaflets of the valve by a portion of the prosthetic valve.
There is also provided, in accordance with some applications of the present invention, apparatus including a valve support for receiving a prosthetic valve, the valve support including:
an annular element configured to be positioned along a native annulus of a native atrioventricular valve of a patient, the annular element having upper and lower surfaces; and
one or more annular element tissue anchors coupled to the lower surface of the annular element, the one or more annular element tissue anchors being configured to puncture tissue of the native annulus of the patient.
In some applications of the present invention, the valve support is collapsible for transcatheter delivery and expandable to contact the native atrioventricular valve.
In some applications of the present invention, the one or more annular element tissue anchors includes a plurality of annular element tissue anchors positioned around the lower surface of the annular element.
In some applications of the present invention, the one or more annular element tissue anchors includes a first commissural annular element tissue anchor configured to puncture tissue of the native valve at a first commissure thereof, and a second commissural annular element tissue anchor configured to puncture tissue of the native valve at a second commissure thereof.
In some applications of the present invention, each anchor of the one or more annular element tissue anchors includes a distal pointed tip and one or more radially-expandable prongs, the prongs being configured to expand and facilitate anchoring of the anchor and restrict proximal motion of the anchor.
In some applications of the present invention, the apparatus includes one or more valve support guide members configured to be delivered to one or more commissures of the native atrioventricular valve of the patient, the one or more valve support guide members are configured to facilitate advancement of the valve support toward the native valve.
In some applications of the present invention, the valve support is shaped so as to define one or more holes, the one or more holes configured to facilitate slidable passage therethrough of a respective one of the one or more valve support guide members.
In some applications of the present invention, the one or more valve support guide members includes one valve support guide member that is looped through first and second commissures of the atrioventricular valve in a manner in which a looped portion of the valve support guide member is disposed in a ventricle of the patient and first and second free ends of the valve support guide member are accessible from a site outside a body of the patient.
In some applications of the present invention, the apparatus includes one or more valve support tissue anchors that are distinct from the valve support and are configured to be advanceable along the one or more valve support guide members and anchored to the one or more commissures of the valve.
In some applications of the present invention, the one or more valve support anchors includes one or more ventricular anchors, and the apparatus further includes one or more atrial anchors, each atrial anchor being configured to be advanced toward an atrial surface of the valve support and anchor in place the valve support in a vicinity of a respective one of the ventricular anchors.
In some applications of the present invention, the one or more valve support guide members are removable from the patient following the anchoring of the valve support at the atrioventricular valve.
In some applications of the present invention, the one or more valve support tissue anchors are configured to be anchored to the one or more commissures from ventricular surfaces thereof prior to advancement of the valve support.
In some applications of the present invention, the one or more valve support tissue anchors includes first and second valve support tissue anchors, the first and second valve support tissue anchors being configured to be anchored to respective first and second commissures of the atrioventricular valve of the patient.
In some applications of the present invention:
the one or more valve support tissue anchors each include one or more radially-expandable prongs, and
the one or more prongs are disposed within a sheath in a compressed state prior to the anchoring and exposed from within the sheath in order to expand and facilitate anchoring of the anchor to the respective commissures.
In some applications of the present invention, the valve support further includes a flexible generally cylindrical element coupled to the annular element and configured to be positioned in the native atrioventricular valve of the patient and to push aside native leaflets of the native valve, the cylindrical element having first and second ends and a cylindrical body that is disposed between the first and second ends.
In some applications of the present invention, the cylindrical element includes a flexible wireframe covered by a fabric.
In some applications of the present invention, the apparatus includes one or more prosthetic valve guide members reversibly couplable to the cylindrical element in a vicinity of the second end of the cylindrical element, the prosthetic valve guide members being configured to facilitate advancement of the prosthetic valve therealong and toward the valve support.
In some applications of the present invention, the apparatus includes the prosthetic valve, the prosthetic valve is couplable to the valve support.
In some applications of the present invention:
In some applications of the present invention:
during the first period, the second end of the cylindrical element is disposed in an atrium of a heart of the patient,
the prosthetic valve is advanceable along the one or more prosthetic valve guide members into a ventricle of the heart of the patient, and
in response to advancement of the prosthetic valve into the ventricle, the one or more prosthetic valve guide members are pulled into the ventricle and pull the second end of the cylindrical element into the ventricle to invert the cylindrical element.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
Reference is now made to
For some applications, guide members 21 (e.g., guide members 21a and 21b ) comprise guide wires having a diameter of 0.035 inches.
The transcatheter procedure typically begins with the advancing of a semi-rigid guide wire into a right atrium 4 of the patient. The semi-rigid guide wire provides a guide for the subsequent advancement of a sheath 25 therealong and into the right atrium. Once sheath 25 has entered the right atrium, the semi-rigid guide wire is retracted from the patient's body. Sheath 25 typically comprises a 13-20 F sheath, although the size may be selected as appropriate for a given patient. Sheath 25 is advanced through vasculature into the right atrium using a suitable point of origin typically determined for a given patient. For example:
In some applications of the present invention, sheath 25 is advanced through the inferior vena cava of the patient and into the right atrium using a suitable point of origin typically determined for a given patient.
Sheath 25 is advanced distally until sheath 25 reaches the interatrial septum. For some applications, a resilient needle and a dilator (not shown) are advanced through the sheath and into the heart. In order to advance the sheath transseptally into the left atrium, the dilator is advanced to the septum, and the needle is pushed from within the dilator and is allowed to puncture the septum to create an opening that facilitates passage of the dilator and subsequently the sheath therethrough and into the left atrium. The dilator is passed through the hole in the septum created by the needle. Typically, the dilator is shaped to define a hollow shaft for passage along the needle, and the hollow shaft is shaped to define a tapered distal end. This tapered distal end is first advanced through the hole created by the needle. The hole is enlarged when the gradually increasing diameter of the distal end of the dilator is pushed through the hole in the septum.
The advancement of sheath 25 through the septum and into the left atrium is followed by the extraction of the dilator and the needle from within sheath 25.
As shown in
Anchors 30a and 30b, ribbed crimping structures 34, and the distal ends of surrounding sheaths 26a and 26b are advanced into ventricle 6. Subsequently, anchors 30a and 30b are pushed distally from within sheaths 26a and 26b, (or sheaths 26a and 26b are pulled proximally with respect to anchors 30a and 30b) to expose anchors 30a and 30b. As anchors 30a and 30b are exposed from within sheaths 26a and 26b, prongs 32 are free to expand, as shown in
As shown in
For some applications, following the anchoring of anchors 30a and 30b to commissures 8 and 10, respectively, guide members 21a and 21b are removed from the body of the patient.
Reference is now made to
It is to be noted that support 40 is slid along lumens 27a and 27b by way of illustration and not limitation. That is, for some applications, following the anchoring of anchors 30a and 30b to commissures 8 and 10, respectively, guide members 21a and 21b are not removed from the body of the patient, but rather lumens 27a and 27b are removed (e.g., by being decoupled from crimping structures 34) leaving behind anchors 30a and 30b and guide members 21a and 21b. Guide members 21a and 21b may then be threaded through holes 46a and 46b, respectively, and support 40 is slid along guide members 21a and 21b. In such a manner, guide members 21a and 21b function as valve support guide members.
Support 40 comprises a collapsible flexible support frame 48, which is at least partially covered by a covering 49. Support 40 is configured to be placed at native valve 5, such that cylindrical element 42 passes through the orifice of the native valve and extends towards, and, typically partially into, ventricle 6 (as shown in
For some applications, collapsible support frame 48 comprises a stent, which comprises a plurality of struts. The struts may comprise, for example, a metal such as nitinol or stainless steel. For some applications frame 48 comprises a flexible metal, e.g., nitinol, which facilitates compression of support 40 within a delivery sheath or overtube 50. For some applications, covering 49 comprises a fabric, such as a woven fabric, e.g., Dacron. Covering 49 is typically configured to cover at least a portion of cylindrical element 42, and at least a portion of annular element 44. The covering may comprise a single piece, or a plurality of pieces sewn together.
As shown in
In
Responsively to the placement of valve support 40 at native valve 5, cylindrical element 42 is positioned partially within ventricle 6 and native leaflets 12 and 14 of native valve 5 are pushed aside.
As shown in section A-A, ribbed crimping structures 34 are shaped so as to define a plurality of male couplings. Locking crimping elements 64a and 64b each comprise a cylindrical element having an inner lumen that is shaped so as to surround a respective ribbed crimping structure 34. Each inner lumen of locking crimping elements 64a and 64b is shaped so as to define female couplings to receive the male couplings of ribbed crimping structure 34. The female couplings of locking crimping element 64 are directioned such that they facilitate distal advancement of locking crimping element 64 while restricting proximal advancement of locking crimping element 64. When the female couplings of locking crimping element 64 receive the male couplings of ribbed crimping structure 34, valve support 40 is locked in place from an atrial surface of valve 5. It is to be noted that for some applications, ribbed crimping elements 34 comprise female couplings, and locking crimping elements 64 comprise male couplings.
Reference is now made to
Following the placement of support 40 at annulus 11, pushing elements 52a and 52b and sheath or overtube 50 are removed from the body of the patient, leaving behind lumens 27a and 27b, as shown in
As shown in
Following the partial deployment of valve 80 in ventricle 6, overtube 70 is pulled proximally to pull valve 80 proximally such that cylindrical element 42 of valve support 40 surrounds a distal portion of prosthetic valve 80. Valve 80 has a tendency to expand such that valve 80 is held in place with respect to valve support 40 responsively to radial forces acted upon valve support 40 by prosthetic valve 80.
Valve 80 comprises a plurality of distal snares 84. When valve 80 is pulled proximally, as described hereinabove, snares 84 ensnare and engage the native leaflets of the atrioventricular valve. By the ensnaring of the native leaflets, snares 84 sandwich the native valve between snares 84 and prosthetic valve support 40. Such ensnaring helps further anchor prosthetic valve 80 to the native atrioventricular valve.
Additionally, as shown in
Prosthetic valve 80 is configured for implantation in and/or at least partial replacement of a native atrioventricular valve 5 of the patient, such as a native mitral valve or a native tricuspid valve. Prosthetic valve 80 is configured to assume a collapsed state for minimally-invasive delivery to the diseased native valve, such as by percutaneous or transluminal delivery using one or more catheters.
Reference is now made to
Reference is now made to
Valve support 140 comprises an annular element 144 (that is identical to annular element 44 described hereinabove) and a cylindrical element 142. Cylindrical element 142 has a first end 150, a second end 152, and a cylindrical body 153 disposed between first and second ends 150 and 152. Cylindrical element 142 is attached to annular element 144 at first end 150 of cylindrical element 142.
During and following implantation of support 140 at annulus 11, as shown in
The configuration of valve support 140 as shown in
Reference is now made to
Reference is now made to
Reference is made to
In
Reference is now made to
Systems 20, 120, and 220 are advanced toward valve 5 in a transcatheter procedure, as shown. It is to be noted, however, that systems 20, 120, and 220 may be advanced using any suitable procedure, e.g., minimally-invasive or open-heart. It is to be further noted that systems 20, 120, and 220 may be used to replace them mitral valve, as shown, and the tricuspid valve (not shown), mutatis mutandis.
For some applications, techniques described herein are practiced in combination with techniques described in one or more of the references cited in the Background section of the present patent application.
Additionally, techniques described herein may be performed in combination with techniques described in one or more of the following patent application, all of which are incorporated herein by reference:
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4261342 | Aranguren Duo | Apr 1981 | A |
| 4892541 | Alonso | Jan 1990 | A |
| 5108420 | Marks | Apr 1992 | A |
| 5607444 | Lam | Mar 1997 | A |
| 5607470 | Milo | Mar 1997 | A |
| 5868777 | Lam | Feb 1999 | A |
| 6042607 | Williamson, IV et al. | Mar 2000 | A |
| 6074417 | Peredo | Jun 2000 | A |
| 6113612 | Swanson et al. | Sep 2000 | A |
| 6120534 | Ruiz | Sep 2000 | A |
| 6152937 | Peterson et al. | Nov 2000 | A |
| 6287339 | Vazquez et al. | Sep 2001 | B1 |
| 6332893 | Mortier et al. | Dec 2001 | B1 |
| 6391036 | Berg et al. | May 2002 | B1 |
| 6402780 | Williamson, IV et al. | Jun 2002 | B2 |
| 6409755 | Vrba | Jun 2002 | B1 |
| 6419696 | Ortiz et al. | Jul 2002 | B1 |
| 6428550 | Vargas et al. | Aug 2002 | B1 |
| 6440164 | DiMatteo et al. | Aug 2002 | B1 |
| 6458153 | Bailey et al. | Oct 2002 | B1 |
| 6511491 | Grudem et al. | Jan 2003 | B2 |
| 6530952 | Vesely | Mar 2003 | B2 |
| 6540782 | Snyders | Apr 2003 | B1 |
| 6558418 | Carpentier et al. | May 2003 | B2 |
| 6602263 | Swanson et al. | Aug 2003 | B1 |
| 6616675 | Evard et al. | Sep 2003 | B1 |
| 6699256 | Logan et al. | Mar 2004 | B1 |
| 6716244 | Klaco | Apr 2004 | B2 |
| 6719781 | Kim | Apr 2004 | B1 |
| 6730118 | Spenser et al. | May 2004 | B2 |
| 6767362 | Schreck | Jul 2004 | B2 |
| 6830585 | Artof et al. | Dec 2004 | B1 |
| 6830638 | Boylan et al. | Dec 2004 | B2 |
| 6960217 | Bolduc | Nov 2005 | B2 |
| 6964684 | Ortiz et al. | Nov 2005 | B2 |
| 7011681 | Vesely | Mar 2006 | B2 |
| 7018406 | Seguin et al. | Mar 2006 | B2 |
| 7041132 | Quijano et al. | May 2006 | B2 |
| 7077861 | Spence | Jul 2006 | B2 |
| 7101395 | Tremulis et al. | Sep 2006 | B2 |
| 7172625 | Shu et al. | Feb 2007 | B2 |
| 7198646 | Figulla et al. | Apr 2007 | B2 |
| 7201772 | Schwammenthal et al. | Apr 2007 | B2 |
| 7288111 | Holloway et al. | Oct 2007 | B1 |
| 7335213 | Hyde et al. | Feb 2008 | B1 |
| 7404824 | Webler et al. | Jul 2008 | B1 |
| 7422603 | Lane | Sep 2008 | B2 |
| 7429269 | Schwammenthal et al. | Sep 2008 | B2 |
| 7442204 | Schwammenthal et al. | Oct 2008 | B2 |
| 7455677 | Vargas et al. | Nov 2008 | B2 |
| 7455688 | Furst et al. | Nov 2008 | B2 |
| 7462162 | Phan et al. | Dec 2008 | B2 |
| 7481838 | Carpentier et al. | Jan 2009 | B2 |
| 7510575 | Spenser et al. | Mar 2009 | B2 |
| 7513909 | Lane et al. | Apr 2009 | B2 |
| 7527646 | Rahdert et al. | May 2009 | B2 |
| 7582111 | Krolik et al. | Sep 2009 | B2 |
| 7585321 | Cribier | Sep 2009 | B2 |
| 7632302 | Vreeman et al. | Dec 2009 | B2 |
| 7708775 | Rowe et al. | May 2010 | B2 |
| 7717955 | Lane et al. | May 2010 | B2 |
| 7731741 | Eidenschink | Jun 2010 | B2 |
| 7753922 | Starksen | Jul 2010 | B2 |
| 7771467 | Svensson | Aug 2010 | B2 |
| 7771469 | Liddicoat | Aug 2010 | B2 |
| 7780726 | Seguin | Aug 2010 | B2 |
| 7799069 | Bailey et al. | Sep 2010 | B2 |
| 7803181 | Furst et al. | Sep 2010 | B2 |
| 7837727 | Goetz et al. | Nov 2010 | B2 |
| 7842081 | Yadin | Nov 2010 | B2 |
| 7850725 | Vardi et al. | Dec 2010 | B2 |
| 7871432 | Bergin | Jan 2011 | B2 |
| 7871436 | Ryan et al. | Jan 2011 | B2 |
| 7887583 | Macoviak | Feb 2011 | B2 |
| 7892281 | Seguin et al. | Feb 2011 | B2 |
| 7896915 | Guyenot et al. | Mar 2011 | B2 |
| 7914544 | Nguyen et al. | Mar 2011 | B2 |
| 7914569 | Nguyen et al. | Mar 2011 | B2 |
| 7947072 | Yang et al. | May 2011 | B2 |
| 7947075 | Goetz et al. | May 2011 | B2 |
| 7955375 | Agnew | Jun 2011 | B2 |
| 7955384 | Rafiee et al. | Jun 2011 | B2 |
| 7967833 | Sterman et al. | Jun 2011 | B2 |
| 7967857 | Lane | Jun 2011 | B2 |
| 7981151 | Rowe | Jul 2011 | B2 |
| 7981153 | Fogarty et al. | Jul 2011 | B2 |
| 7992567 | Hirotsuka et al. | Aug 2011 | B2 |
| 7993393 | Carpentier et al. | Aug 2011 | B2 |
| 8002825 | Letac et al. | Aug 2011 | B2 |
| 8016877 | Seguin et al. | Sep 2011 | B2 |
| 8016882 | Macoviak et al. | Sep 2011 | B2 |
| 8021420 | Dolan | Sep 2011 | B2 |
| 8021421 | Fogarty et al. | Sep 2011 | B2 |
| 8029564 | Johnson et al. | Oct 2011 | B2 |
| 8034104 | Carpentier et al. | Oct 2011 | B2 |
| 8043360 | McNamara et al. | Oct 2011 | B2 |
| 8048140 | Purdy | Nov 2011 | B2 |
| 8048153 | Salahieh et al. | Nov 2011 | B2 |
| 8052741 | Bruszewski et al. | Nov 2011 | B2 |
| 8057532 | Hoffman | Nov 2011 | B2 |
| 8057540 | Letac et al. | Nov 2011 | B2 |
| 8062355 | Figulla et al. | Nov 2011 | B2 |
| 8062359 | Marquez et al. | Nov 2011 | B2 |
| 8070708 | Rottenberg et al. | Dec 2011 | B2 |
| 8070802 | Lamphere et al. | Dec 2011 | B2 |
| 8070804 | Hyde et al. | Dec 2011 | B2 |
| 8075611 | Millwee et al. | Dec 2011 | B2 |
| 8080054 | Rowe | Dec 2011 | B2 |
| 8092518 | Schreck | Jan 2012 | B2 |
| 8092520 | Quadri | Jan 2012 | B2 |
| 8092521 | Figulla et al. | Jan 2012 | B2 |
| 8105377 | Liddicoat | Jan 2012 | B2 |
| 8118866 | Herrmann et al. | Feb 2012 | B2 |
| 8136218 | Millwee et al. | Mar 2012 | B2 |
| 8137398 | Tuval et al. | Mar 2012 | B2 |
| 8142492 | Forster et al. | Mar 2012 | B2 |
| 8142494 | Rahdert et al. | Mar 2012 | B2 |
| 8142496 | Berreklouw | Mar 2012 | B2 |
| 8142497 | Friedman | Mar 2012 | B2 |
| 8147504 | Ino et al. | Apr 2012 | B2 |
| 8157852 | Bloom et al. | Apr 2012 | B2 |
| 8157853 | Laske et al. | Apr 2012 | B2 |
| 8157860 | McNamara et al. | Apr 2012 | B2 |
| 8163014 | Lane et al. | Apr 2012 | B2 |
| 8167894 | Miles et al. | May 2012 | B2 |
| 8167932 | Bourang et al. | May 2012 | B2 |
| 8172896 | McNamara et al. | May 2012 | B2 |
| 8177836 | Lee et al. | May 2012 | B2 |
| 8182528 | Salahieh et al. | May 2012 | B2 |
| 8211169 | Lane et al. | Jul 2012 | B2 |
| 8221492 | Case et al. | Jul 2012 | B2 |
| 8221493 | Boyle et al. | Jul 2012 | B2 |
| 8226710 | Nguyen et al. | Jul 2012 | B2 |
| 8231670 | Salahieh et al. | Jul 2012 | B2 |
| 8236045 | Benichou et al. | Aug 2012 | B2 |
| 8236049 | Rowe et al. | Aug 2012 | B2 |
| 8252042 | McNamara et al. | Aug 2012 | B2 |
| 8252051 | Chau et al. | Aug 2012 | B2 |
| 8252052 | Salahieh et al. | Aug 2012 | B2 |
| 8257390 | Carley et al. | Sep 2012 | B2 |
| 8277501 | Chalekian et al. | Oct 2012 | B2 |
| 8287591 | Keidar et al. | Oct 2012 | B2 |
| 8298280 | Yadin et al. | Oct 2012 | B2 |
| 8308798 | Pintor et al. | Nov 2012 | B2 |
| 8317853 | Agnew | Nov 2012 | B2 |
| 8317855 | Gregorich et al. | Nov 2012 | B2 |
| 8323335 | Rowe et al. | Dec 2012 | B2 |
| 8328868 | Paul et al. | Dec 2012 | B2 |
| 8343174 | Goldfarb et al. | Jan 2013 | B2 |
| 8430934 | Das | Apr 2013 | B2 |
| 8449625 | Campbell et al. | May 2013 | B2 |
| 8696742 | Pintor et al. | Apr 2014 | B2 |
| 20010021872 | Bailey et al. | Sep 2001 | A1 |
| 20020151970 | Garrison et al. | Oct 2002 | A1 |
| 20030036791 | Philipp et al. | Feb 2003 | A1 |
| 20030074052 | Besselink | Apr 2003 | A1 |
| 20030083742 | Spence et al. | May 2003 | A1 |
| 20030105519 | Fasol et al. | Jun 2003 | A1 |
| 20030158578 | Pantages et al. | Aug 2003 | A1 |
| 20040039414 | Carley et al. | Feb 2004 | A1 |
| 20040093060 | Seguin et al. | May 2004 | A1 |
| 20040122514 | Fogarty et al. | Jun 2004 | A1 |
| 20040176839 | Huynh et al. | Sep 2004 | A1 |
| 20040186565 | Schreck | Sep 2004 | A1 |
| 20040186566 | Hindrichs et al. | Sep 2004 | A1 |
| 20040210244 | Vargas et al. | Oct 2004 | A1 |
| 20040225354 | Allen et al. | Nov 2004 | A1 |
| 20040260389 | Case et al. | Dec 2004 | A1 |
| 20050004668 | Aklog et al. | Jan 2005 | A1 |
| 20050075731 | Artof et al. | Apr 2005 | A1 |
| 20050137688 | Salahieh et al. | Jun 2005 | A1 |
| 20050137689 | Salahieh et al. | Jun 2005 | A1 |
| 20050137690 | Salahieh et al. | Jun 2005 | A1 |
| 20050137695 | Salahieh et al. | Jun 2005 | A1 |
| 20050143809 | Salahieh et al. | Jun 2005 | A1 |
| 20050197695 | Stacchino et al. | Sep 2005 | A1 |
| 20050203549 | Realyvasquez | Sep 2005 | A1 |
| 20050216079 | MaCoviak | Sep 2005 | A1 |
| 20050234508 | Cummins et al. | Oct 2005 | A1 |
| 20050240200 | Bergheim | Oct 2005 | A1 |
| 20050251251 | Cribier | Nov 2005 | A1 |
| 20050267573 | Macoviak et al. | Dec 2005 | A9 |
| 20060047297 | Case | Mar 2006 | A1 |
| 20060135964 | Vesely | Jun 2006 | A1 |
| 20060178740 | Stacchino et al. | Aug 2006 | A1 |
| 20060190036 | Wendel et al. | Aug 2006 | A1 |
| 20060190038 | Carley et al. | Aug 2006 | A1 |
| 20060195184 | Lane et al. | Aug 2006 | A1 |
| 20060201519 | Frazier et al. | Sep 2006 | A1 |
| 20060241656 | Starksen et al. | Oct 2006 | A1 |
| 20060241748 | Lee et al. | Oct 2006 | A1 |
| 20060247680 | Amplatz et al. | Nov 2006 | A1 |
| 20060253191 | Salahieh et al. | Nov 2006 | A1 |
| 20060259136 | Nguyen et al. | Nov 2006 | A1 |
| 20060271166 | Thill et al. | Nov 2006 | A1 |
| 20060271171 | McQuinn et al. | Nov 2006 | A1 |
| 20070016288 | Gurskis et al. | Jan 2007 | A1 |
| 20070038295 | Case et al. | Feb 2007 | A1 |
| 20070043435 | Seguin et al. | Feb 2007 | A1 |
| 20070112422 | Dehdashtian | May 2007 | A1 |
| 20070118151 | Davidson | May 2007 | A1 |
| 20070162103 | Case et al. | Jul 2007 | A1 |
| 20070162107 | Haug et al. | Jul 2007 | A1 |
| 20070162111 | Fukamachi et al. | Jul 2007 | A1 |
| 20070173932 | Cali et al. | Jul 2007 | A1 |
| 20070198097 | Zegdi | Aug 2007 | A1 |
| 20070213813 | Von Segesser et al. | Sep 2007 | A1 |
| 20070225759 | Thommen et al. | Sep 2007 | A1 |
| 20070225760 | Moszner et al. | Sep 2007 | A1 |
| 20070233186 | Meng | Oct 2007 | A1 |
| 20070233237 | Krivoruchko | Oct 2007 | A1 |
| 20070239272 | Navia et al. | Oct 2007 | A1 |
| 20070255400 | Parravicini et al. | Nov 2007 | A1 |
| 20080004688 | Spenser et al. | Jan 2008 | A1 |
| 20080004697 | Lichtenstein et al. | Jan 2008 | A1 |
| 20080071363 | Tuval et al. | Mar 2008 | A1 |
| 20080071366 | Tuval et al. | Mar 2008 | A1 |
| 20080071369 | Tuval et al. | Mar 2008 | A1 |
| 20080077235 | Kirson | Mar 2008 | A1 |
| 20080086164 | Rowe | Apr 2008 | A1 |
| 20080086204 | Rankin | Apr 2008 | A1 |
| 20080161910 | Revuelta et al. | Jul 2008 | A1 |
| 20080167714 | St. Goar et al. | Jul 2008 | A1 |
| 20080195200 | Vidlund et al. | Aug 2008 | A1 |
| 20080208332 | Lamphere et al. | Aug 2008 | A1 |
| 20080221672 | Lamphere et al. | Sep 2008 | A1 |
| 20080243245 | Thambar et al. | Oct 2008 | A1 |
| 20080262609 | Gross et al. | Oct 2008 | A1 |
| 20080281411 | Berreklouw | Nov 2008 | A1 |
| 20090005863 | Goetz et al. | Jan 2009 | A1 |
| 20090054969 | Salahieh et al. | Feb 2009 | A1 |
| 20090099650 | Bolduc et al. | Apr 2009 | A1 |
| 20090177278 | Spence | Jul 2009 | A1 |
| 20090210052 | Forster et al. | Aug 2009 | A1 |
| 20090264994 | Saadat | Oct 2009 | A1 |
| 20090287304 | Dahlgren et al. | Nov 2009 | A1 |
| 20090319037 | Rowe et al. | Dec 2009 | A1 |
| 20100023117 | Yoganathan et al. | Jan 2010 | A1 |
| 20100036479 | Hill et al. | Feb 2010 | A1 |
| 20100076548 | Konno | Mar 2010 | A1 |
| 20100114299 | Ben Muvhar et al. | May 2010 | A1 |
| 20100131054 | Tuval et al. | May 2010 | A1 |
| 20100137979 | Tuval et al. | Jun 2010 | A1 |
| 20100160958 | Clark | Jun 2010 | A1 |
| 20100161036 | Pintor et al. | Jun 2010 | A1 |
| 20100161042 | Maisano et al. | Jun 2010 | A1 |
| 20100174363 | Castro | Jul 2010 | A1 |
| 20100179643 | Shalev | Jul 2010 | A1 |
| 20100179648 | Richter et al. | Jul 2010 | A1 |
| 20100179649 | Richter et al. | Jul 2010 | A1 |
| 20100217382 | Chau et al. | Aug 2010 | A1 |
| 20100222810 | DeBeer et al. | Sep 2010 | A1 |
| 20100228285 | Miles et al. | Sep 2010 | A1 |
| 20100234940 | Dolan | Sep 2010 | A1 |
| 20100249908 | Chau et al. | Sep 2010 | A1 |
| 20100249917 | Zhang | Sep 2010 | A1 |
| 20100262232 | Annest | Oct 2010 | A1 |
| 20100280606 | Naor | Nov 2010 | A1 |
| 20100324595 | Linder et al. | Dec 2010 | A1 |
| 20110004296 | Lutter et al. | Jan 2011 | A1 |
| 20110015729 | Jimenez et al. | Jan 2011 | A1 |
| 20110015731 | Carpentier et al. | Jan 2011 | A1 |
| 20110022165 | Oba et al. | Jan 2011 | A1 |
| 20110040374 | Goetz et al. | Feb 2011 | A1 |
| 20110040375 | Letac et al. | Feb 2011 | A1 |
| 20110046662 | Moszner et al. | Feb 2011 | A1 |
| 20110054466 | Rothstein et al. | Mar 2011 | A1 |
| 20110054596 | Taylor | Mar 2011 | A1 |
| 20110054598 | Johnson | Mar 2011 | A1 |
| 20110082538 | Dahlgren et al. | Apr 2011 | A1 |
| 20110087322 | Letac et al. | Apr 2011 | A1 |
| 20110093063 | Schreck | Apr 2011 | A1 |
| 20110106247 | Miller et al. | May 2011 | A1 |
| 20110112625 | Ben-Muvhar et al. | May 2011 | A1 |
| 20110112632 | Chau et al. | May 2011 | A1 |
| 20110118830 | Liddicoat et al. | May 2011 | A1 |
| 20110125257 | Seguin et al. | May 2011 | A1 |
| 20110125258 | Centola | May 2011 | A1 |
| 20110137326 | Bachman | Jun 2011 | A1 |
| 20110137397 | Chau et al. | Jun 2011 | A1 |
| 20110137409 | Yang et al. | Jun 2011 | A1 |
| 20110137410 | Hacohen | Jun 2011 | A1 |
| 20110166636 | Rowe | Jul 2011 | A1 |
| 20110172784 | Richter et al. | Jul 2011 | A1 |
| 20110178597 | Navia et al. | Jul 2011 | A9 |
| 20110190877 | Lane et al. | Aug 2011 | A1 |
| 20110190879 | Bobo et al. | Aug 2011 | A1 |
| 20110202076 | Richter | Aug 2011 | A1 |
| 20110208283 | Rust | Aug 2011 | A1 |
| 20110208293 | Tabor | Aug 2011 | A1 |
| 20110208298 | Tuval et al. | Aug 2011 | A1 |
| 20110213461 | Seguin et al. | Sep 2011 | A1 |
| 20110218619 | Benichou et al. | Sep 2011 | A1 |
| 20110218620 | Meiri et al. | Sep 2011 | A1 |
| 20110224785 | Hacohen | Sep 2011 | A1 |
| 20110245911 | Quill et al. | Oct 2011 | A1 |
| 20110245917 | Savage et al. | Oct 2011 | A1 |
| 20110251675 | Dwork | Oct 2011 | A1 |
| 20110251676 | Sweeney et al. | Oct 2011 | A1 |
| 20110251679 | Wiemeyer et al. | Oct 2011 | A1 |
| 20110251680 | Tran et al. | Oct 2011 | A1 |
| 20110251682 | Murray, III et al. | Oct 2011 | A1 |
| 20110251683 | Tabor | Oct 2011 | A1 |
| 20110257721 | Tabor | Oct 2011 | A1 |
| 20110257729 | Spenser et al. | Oct 2011 | A1 |
| 20110257736 | Marquez et al. | Oct 2011 | A1 |
| 20110257737 | Fogarty et al. | Oct 2011 | A1 |
| 20110264191 | Rothstein | Oct 2011 | A1 |
| 20110264196 | Savage et al. | Oct 2011 | A1 |
| 20110264198 | Murray, III et al. | Oct 2011 | A1 |
| 20110264199 | Tran et al. | Oct 2011 | A1 |
| 20110264200 | Tran et al. | Oct 2011 | A1 |
| 20110264201 | Yeung et al. | Oct 2011 | A1 |
| 20110264202 | Murray, III et al. | Oct 2011 | A1 |
| 20110264203 | Dwork et al. | Oct 2011 | A1 |
| 20110264206 | Tabor | Oct 2011 | A1 |
| 20110264208 | Duffy et al. | Oct 2011 | A1 |
| 20110270276 | Rothstein et al. | Nov 2011 | A1 |
| 20110271967 | Mortier et al. | Nov 2011 | A1 |
| 20110282438 | Drews et al. | Nov 2011 | A1 |
| 20110283514 | Fogarty et al. | Nov 2011 | A1 |
| 20110288634 | Tuval et al. | Nov 2011 | A1 |
| 20110301688 | Dolan | Dec 2011 | A1 |
| 20110301702 | Rust et al. | Dec 2011 | A1 |
| 20110313452 | Carley et al. | Dec 2011 | A1 |
| 20110319989 | Lane | Dec 2011 | A1 |
| 20110319991 | Hariton et al. | Dec 2011 | A1 |
| 20120010694 | Lutter et al. | Jan 2012 | A1 |
| 20120022633 | Olson et al. | Jan 2012 | A1 |
| 20120022637 | Ben-Muvhar | Jan 2012 | A1 |
| 20120022639 | Hacohen et al. | Jan 2012 | A1 |
| 20120022640 | Gross et al. | Jan 2012 | A1 |
| 20120035703 | Lutter et al. | Feb 2012 | A1 |
| 20120035713 | Lutter et al. | Feb 2012 | A1 |
| 20120035722 | Tuval | Feb 2012 | A1 |
| 20120041547 | Duffy et al. | Feb 2012 | A1 |
| 20120041551 | Spenser et al. | Feb 2012 | A1 |
| 20120046738 | Lau et al. | Feb 2012 | A1 |
| 20120046742 | Tuval et al. | Feb 2012 | A1 |
| 20120053682 | Kovalsky et al. | Mar 2012 | A1 |
| 20120053688 | Fogarty et al. | Mar 2012 | A1 |
| 20120059454 | Millwee et al. | Mar 2012 | A1 |
| 20120078353 | Quadri et al. | Mar 2012 | A1 |
| 20120078357 | Conklin | Mar 2012 | A1 |
| 20120083832 | Delaloye et al. | Apr 2012 | A1 |
| 20120083839 | Letac et al. | Apr 2012 | A1 |
| 20120083879 | Eberhardt et al. | Apr 2012 | A1 |
| 20120089223 | Nguyen et al. | Apr 2012 | A1 |
| 20120101570 | Tuval et al. | Apr 2012 | A1 |
| 20120101572 | Kovalsky et al. | Apr 2012 | A1 |
| 20120123530 | Carpentier et al. | May 2012 | A1 |
| 20120136434 | Carpentier et al. | May 2012 | A1 |
| 20120150218 | Sandgren et al. | Jun 2012 | A1 |
| 20120197292 | Chin-Chen et al. | Aug 2012 | A1 |
| 20120283824 | Lutter et al. | Nov 2012 | A1 |
| 20120290062 | McNamara et al. | Nov 2012 | A1 |
| 20120310328 | Olson et al. | Dec 2012 | A1 |
| 20120323316 | Chau et al. | Dec 2012 | A1 |
| 20130035759 | Gross et al. | Feb 2013 | A1 |
| 20130261737 | Costello | Oct 2013 | A1 |
| 20130304197 | Buchbinder et al. | Nov 2013 | A1 |
| 20130325114 | McLean et al. | Dec 2013 | A1 |
| 20140005778 | Buchbinder et al. | Jan 2014 | A1 |
| 20140052237 | Lane et al. | Feb 2014 | A1 |
| Number | Date | Country |
|---|---|---|
| 1264582 | Dec 2002 | EP |
| 9930647 | Jun 1999 | WO |
| 0047139 | Aug 2000 | WO |
| 0162189 | Aug 2001 | WO |
| 2006054930 | May 2006 | WO |
| 2008013915 | Jan 2008 | WO |
| 2009033469 | Mar 2009 | WO |
| 2009053497 | Apr 2009 | WO |
| 2010006627 | Jan 2010 | WO |
| 2010073246 | Jul 2010 | WO |
| 2011106137 | Sep 2011 | WO |
| 2011111047 | Sep 2011 | WO |
| 2011143263 | Nov 2011 | WO |
| 2012011108 | Jan 2012 | WO |
| 2013021374 | Feb 2013 | WO |
| 2013021375 | Feb 2013 | WO |
| 2013078497 | Jun 2013 | WO |
| 2013128436 | Sep 2013 | WO |
| Entry |
|---|
| Alexander S. Geha, et al; “Replacement of Degenerated Mitral and Aortic Bioprostheses Without Explanation” Ann. Thorac Surg 2001; 72:1509-1514; Accepted for Publication Jun. 1, 2001. |
| John G. Webb, et al; “Transcatheter Valve-in-Valve Implantation for Failed Bioprosthetic Heart Valves”, Circulation 2010; 121; 1848-1857, originally published online Apr. 12, 2010. |
| International Search Report; mailed Oct. 13, 2011; PCT/IL11/00231. |
| Frank Langer, et al; “RING plus STRING: Papillary muscle repositioning as an adjunctive repair technique for ischemic mitral regurgitation”, J. Thorac Cardiovasc Surg 133: 247-9 (2007). |
| Frank Lanfer, et al; “RING + STRING Successful Repair Technique for Ischemic Mitral Regurgitation With Severe Leaflet Tethering”, Circulation 120[suppl 1]: S85-S91, (2009). |
| John G. Webb, et al; “Transcatheter Valve-in-Valve Implantation for Failed Bioprosthetic Heart Valves”, Circulation, Apr. 27, 2010, vol. 121, No. 16, pp. 1848-1857. |
| J. Jansen, et al; “Detachable shape-memory sewing ring for heart valves” Artificial Organs, vol. 16, Issue 3, pp. 294-297, Jun. 1992. |
| Alexander S. Geha, et el; “Replacement of Degenerated Mitral and Aortic Boprostheses Without Explantation”, The Annuals of Thoracic Surgery, vol. 72, Issue 5, Nov. 2001, pp. 1509-1514. |
| International Search Report and Written Opinion dated Dec. 5, 2011, issued during prosecution of PCT/IL11/00582. |
| USPTO NFOA dated Nov. 28, 2012 in connection with U.S. Appl. No. 12/961,721. |
| USPTO NFOA dated Nov. 23, 2012 in connection with U.S. Appl. No. 13/033,852. |
| USPTO NFOA dated Dec. 31, 2012 in connection with U.S. Appl. No. 13/044,694. |
| USPTO NFOA dated Feb. 6, 2013 in connection with U.S. Appl. No. 13/412,814. |
| International Search Report and Written Opinion dated Feb. 6, 2013 PCT/IL12/00292. |
| International Search Report and Written Opinion dated Feb. 6, 2013 PCT/IL12/00293. |
| An Office Action dated Jul. 18, 2013, which issued during the prosecution of U.S. Appl. No. 13/044,694. |
| An Office Action dated Aug. 2, 2013, which issued during the prosecution of U.S. Appl. No. 13/033,852. |
| USPTO NFOA dated Sep. 12, 2013 in connection with U.S. Appl. No. 13/412,814. |
| International Preliminary Report on Patentability dated Dec. 2, 2013; PCT/IL11/00582. |
| USPTO NFOA dated Jul. 3, 2014 in connection with U.S. Appl. No. 13/033,852. |
| USPTO FOA dated May 23, 2014 in connection with U.S. Appl. No. 13/412,814. |
| USPTO NFOA dated Jul. 2, 2014 in connection with U.S. Appl. No. 13/811,308. |
| Invitation to Pay Additional Fees dted Jun. 12, 2014; PCT/IL2014/050087. |
| International Search Report and Written Opinion dated Sep. 4, 2014;PCT/IL2014/050087. |
| USPTO NFOA dated Sep. 19, 2014 in connection with U.S. Appl. No. 13/044,694. |
| Number | Date | Country | |
|---|---|---|---|
| 20120022639 A1 | Jan 2012 | US |
