WO2012036798A1 - Devices, methods and kits for heart valve replacement - Google Patents

Abstract

Heart valve replacement devices, methods and kits are described here. A method may comprise advancing a first catheter into the left ventricle of a heart so that the first catheter is positioned beneath the mitral valve of the heart, advancing a replacement valve from the first catheter while the first catheter is in its position beneath the mitral valve of the heart, such that the replacement valve passes between the mitral valve leaflets and up into the left atrium of the heart, and coupling the replacement valve to tissue in the vicinity of the mitral valve. Replacement valves may be coupled to tissue using, for example, one or more anchors. The anchors may be coupled to each other with a tensioning member which may be tensioned to provide a cinching effect that results in radial contraction of tissue in the vicinity of the replacement and/or native valve.

Description

DEVICES, METHODS AND KITS FOR HEART VALVE REPLACEMENT

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 61/370,757 filed on August 4, 2010, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The devices, methods, and kits described herein related generally to heart valve replacement procedures, such as mitral valve replacement procedures. More specifically, the devices, methods, and kits described herein relate to advancing a device carrying a replacement valve into a subvalvular space of a heart, passing the device and/or the replacement valve from a location beneath the valve up through the valve (e.g., between leaflets of the valve), delivering the replacement valve in the area of the native valve and, in some cases, radially contracting tissue in the area of the native valve.

BACKGROUND

[0003] Blood returning to the heart from the peripheral circulation and the lungs generally flows into the atrial chambers of the heart and then to the ventricular chambers, which pump the blood back out of the heart. During ventricular contraction, the atrio-ventricular valves between the atria and ventricles (i.e., the tricuspid and mitral valves) close to prevent backflow or regurgitation of blood from the ventricles back to the atria. The closure of these valves, along with the aortic and pulmonary valves, maintains the uni-directional flow of blood through the

cardiovascular system. Disease of the valvular apparatus can result in valve dysfunction, in which some fraction of the ventricular blood regurgitates back into the atrial chambers. Disease or other damage or abnormalities in the valvular apparatus may result in other problems, as well, such as valve leakage or heart failure.

[0004] In some cases, disease (e.g., degenerative disease) or abnormalities in a native heart valve or damage thereto may make it desirable to replace the native heart valve with a prosthetic valve, which may be a biologic, synthetic, or mechanical valve. The replacement valve may, for example, be delivered to the target site using a surgical or percutaneous method. In certain cases, the target site may be accessed using a thoracotomy or a sternotomy. In some cases, a valve replacement procedure may include resecting the native valve to make room for the replacement valve. Once positioned at a target site, a replacement valve may be secured to the surrounding tissue (e.g., by sewing, suturing, or the like).

[0005] There is a continued need for valve replacement devices and methods, and especially for those that may be used minimally invasively. Thus, it would be desirable to provide additional devices and methods that may be used in heart valve replacement procedures.

SUMMARY

[0006] Described here are devices, methods and kits for replacing a heart valve, such as a mitral valve. Some variations of methods described here may comprise using a catheter to deliver a replacement valve to a mitral valve region of a heart. The catheter may, for example, be advanced into a left ventricle of the heart, to a location beneath the mitral valve of the heart. The catheter may then be advanced up through the mitral valve (e.g., by being passed between the mitral valve leaflets), so that the catheter (e.g., a distal portion thereof) is located within the left atrium of the heart. Once within the left atrium of the heart, the catheter may deliver a replacement valve. The replacement valve may, for example, be delivered into the location of the native valve, which may or may not have been removed prior to delivery of the replacement valve. Alternatively, the catheter may remain beneath the mitral valve, and may be used to deliver a replacement valve up into the left atrium of the heart (e.g., by passing the replacement valve between the mitral valve leaflets).

[0007] The replacement valve may be secured to the heart tissue using, for example, one or more anchors. In some cases, the replacement valve may be secured by multiple anchors that are slidably coupled to a tensioning member, such as a tether. The operator may tension the tensioning member to compress or tighten the tissue to which the anchors are attached. This compression or tightening may, in turn, result in a radial contraction of the tissue in the vicinity of the mitral valve (e.g., thereby enhancing the security of the replacement valve and/or improving its overall function). Other components that effect such radial contraction may alternatively or additionally be used. As an example, in some variations, a replacement valve may be secured (e.g., directly secured) to heart tissue by multiple anchors having one or more shape or position configurations. At the desired time, the anchors may be actuated or otherwise converted to a configuration that results in the surrounding heart tissue being pulled radially inward toward the replacement valve. In certain cases, the replacement valve itself may or may not expand upon being positioned at the target site. For example, the replacement valve may not expand, but the

surrounding tissue may contract around the replacement valve to help seat the valve.

[0008] In some variations, a method may comprise advancing a first catheter into the left ventricle of a heart so that the first catheter is positioned beneath the mitral valve of the heart (e.g., in the vicinity of the subannular groove of the left ventricle), advancing a replacement valve from the first catheter while the first catheter is in its position beneath the mitral valve of the heart, such that the replacement valve passes between the mitral valve leaflets and up into the left atrium of the heart, and coupling the replacement valve to tissue in the vicinity of the mitral valve.

[0009] In certain variations, a method may comprise advancing a first catheter into the left ventricle of a heart so that the first catheter is positioned beneath the mitral valve of the heart (e.g., in the vicinity of the subannular groove of the left ventricle), passing the first catheter from its position beneath the mitral valve of the heart between the mitral valve leaflets and up into the left atrium of the heart, advancing a replacement valve from the first catheter after the first catheter has been advanced into the left atrium of the heart, and coupling the replacement valve to tissue in the vicinity of the mitral valve.

[0010] The method may comprise using at least one anchor to couple the replacement valve to tissue in the vicinity of the mitral valve. In some variations, a plurality of anchors may be used to couple the replacement valve to tissue in the vicinity of the mitral valve. The anchors may be coupled to each other by a coupling member, such as a tether. In certain variations, the method may comprise tensioning the coupling member (e.g., thereby cinching the anchors). In some variations, the method may comprise radially contract tissue in the vicinity of the mitral valve (e.g., by tensioning the coupling member), and/or radially contracting the replacement valve. In certain variations, the replacement valve may be coupled to tissue in the vicinity of the mitral valve without expanding the mitral valve.

[0011] The replacement valve may, for example, comprise first and second frame members that are coupled to each other. In certain variations, each of the first and second frame members may be semiannular. In some variations, at least one of the first and second frame members may be tubular. In some such variations, coupling the replacement valve to tissue in the vicinity of the mitral valve may comprise advancing a second catheter through at least one of the first and second frame members and deploying at least one anchor through a wall portion of at least one of the first and second frame members, to secure the wall portion to the tissue. Coupling the replacement valve to tissue in the vicinity of the mitral valve may comprise coupling a second catheter to at least one of the first and second frame members, and advancing the second catheter along at least one of the first and second frame members. In some variations, coupling the replacement valve to tissue in the vicinity of the mitral valve may comprise deploying at least one anchor through a wall portion of the second catheter and into the tissue. In certain variations, coupling the replacement valve to tissue in the vicinity of the mitral valve may comprise advancing a second catheter adjacent at least one of the first and second frame members and deploying at least one anchor from the second catheter to couple at least one of the first and second frame members to the tissue. The above-described first and second catheters may in some cases be the same catheter.

[0012] The replacement valve may have a first configuration in which the first and second frame members are adjacent one another, and/or a second configuration in which the first and second frame members form a ring. In some variations, the replacement valve may comprise a valve leaflet portion coupled to the first and second frame members. The valve leaflet portion may be disposed within at least one of the first and second frame members when the replacement valve is deployed from the first catheter. The method may comprise deploying the valve leaflet portion from at least one of the first and second frame members. The valve leaflet portion may, for example, comprise two or three valve leaflets. The method may comprise repositioning at least one valve leaflet of the mitral valve.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIGS. 1A and IB are illustrative depictions of a cross-sectional view of a heart, with FIG. IB further depicting a variation of a guide catheter advanced through the aorta and into the left ventricle.

[0014] FIG. 2 is a flowchart representation of a variation of a method for delivering and deploying a replacement heart valve.

[0015] FIGS. 3A-3I provide a more detailed illustrative depiction of the method of

FIG. 2.

[0016] FIGS. 4A and 4B illustrate the tightening or compression of tissue of a subject using a tether. [0017] FIG. 5 is a flowchart representation of another variation of a method for delivering and deploying a replacement heart valve.

[0018] FIGS. 6A-6H provide a more detailed illustrative depiction of the method of

FIG. 5.

[0019] FIG. 61 is an illustrative depiction of a variation of a catheter engaging a rail member of a replacement heart valve.

[0020] FIG. 7 is a flowchart representation of an additional variation of a method for delivering and deploying a replacement heart valve.

[0021] FIGS. 8A-8C provide a more detailed illustrative depiction of the method of

FIG. 7.

[0022] FIGS. 9A-9D depict a variation of a method for delivering and deploying a replacement heart valve.

DETAILED DESCRIPTION

[0023] Heart valve replacement devices, methods and kits are described here. The devices, methods and kits may be used, for example, to replace a mitral valve, or any other valve as appropriate. In some cases, the methods may include advancing a replacement heart valve into the left ventricle of a heart, to an area beneath the mitral valve of the heart, and up through the mitral valve (e.g., by passing the replacement valve between the mitral valve leaflets), so that the replacement valve is advanced into the left atrium of the heart. The replacement valve may then be positioned in the left atrium and secured to tissue in the vicinity of the mitral valve. In certain variations of methods, a catheter may be used to advance a replacement valve to a target site. At least a portion of the catheter may, for example, be advanced into the left atrium, where the catheter may then deliver the replacement valve. Alternatively, the catheter may be advanced to a location beneath the mitral valve, and may be used to deliver the replacement valve through the mitral valve and up into the left atrium.

[0024] In some variations, a replacement valve may be secured to tissue, such as heart tissue, using one or more anchors. The anchors may in some cases be slidably coupled to a tensioning member, such as a tether. Certain variations of methods may comprise tensioning the tensioning member (e.g., after all of the anchors have been secured to heart tissue). This tensioning may result in a cinching of the anchors, and a corresponding radial contraction of tissue in the vicinity of the replacement valve (e.g., enhancing the stability, position and/or function of the replacement valve). The devices, methods and kits described here may, for example, be relatively easy and efficient to use, and may result in a well-secured replacement valve. For example, the devices, methods and kits described here may be used minimally invasively, may not require cardiopulmonary bypass, and/or may be amenable to structural or functional valve disease.

[0025] Typically, the methods described here may be transvascular, minimally invasive or other "less invasive" surgical procedures. However, if appropriate, they may also be performed with open or limited access surgical procedures. In some instances, and as discussed above, the methods may involve deploying a plurality of slidably coupled anchors to secure a replacement valve to surrounding tissue, and drawing the anchors together to reduce the annular dimensions of the surrounding tissue. More specifically, drawing the anchors together typically causes the tissue between the anchors to contract. This, in turn, may radially contract the tissue toward the replacement valve, which may thereby result in enhanced securing of the replacement valve to the tissue (and, e.g., enhanced overall function of the replacement valve). In some variations, self-securing anchors may be used to secure a replacement valve to tissue. Such self- securing anchors may have any of a number of different configurations, and may be used with other self-securing anchors, and/or with anchors that do not self-secure.

[0026] While valve replacement devices, methods and kits are generally described here with respect to the replacement of mitral valves, it should be understood that the devices, methods and kits described here may be used in the replacement of other valves (e.g., tricuspid, pulmonary or aortic valves), as appropriate. Thus, although the description herein discloses specific examples of devices and methods for mitral valve replacement, the devices and methods may be used in any suitable procedure, both cardiac and non-cardiac. Likewise, examples provided below are directed to the left ventricle and left atrium of a heart, but the devices, methods and kits may also be adapted by one of ordinary skill in the art for use in the right ventricle and/or right atrium. Access to other regions of the heart or even to other regions outside of the heart may be achieved by any appropriate method. For example, access to the other chambers of the heart may be performed through percutaneous or venous cut-down access, including but not limited to transjugular, subclavicular and femoral vein access routes. When venous access is established, access to the right atrium, the right ventricle, the tricuspid valve and other right-sided cardiac structures can occur. Furthermore, access to left-sided heart structures, such as the left atrium, left ventricle, mitral valve and aortic valve, may be subsequently achieved by performing a transseptal puncture procedure. In still other variations, a catheter device may access the coronary sinus and a valve procedure may be performed directly from the sinus.

[0027] Turning now to the figures, FIG. 1A shows a cross-sectional view of a heart (H) including an aorta (AO), a superior vena cava (SVC), a right atrium (RA), a right ventricle (RV), a left atrium (LA), and a left ventricle (LV). As shown in FIG. 1A, a mitral valve (MV) comprising mitral valve leaflets (MVL) separates left atrium (LA) from left ventricle (LV), while a tricuspid valve (TV) comprising tricuspid valve leaflets (TVL) separates right atrium (RA) from right ventricle (RV). There are two mitral valve leaflets (MVL), the anteromedial leaflet and the posterolateral leaflet. In some cases, mitral valve leaflets (MVL) and/or tricuspid valve leaflets (TVL) may be referred to more generally as leaflets. Heart (H) also includes papillary muscles in its right ventricle (RVPM), as well as papillary muscles in its left ventricle (LVPM). Additionally, the mitral valve and the tricuspid valve each comprise a valve annulus (not shown), which generally comprises an area of heart wall tissue at the junction of a ventricular wall and an atrial wall. As used herein, the term "annular tissue" shall include both the valve annulus and the tissue adjacent to or surrounding the valve annulus. FIG. 1A also shows a primary chorda tendinea (PCT), secondary chorda tendinea (SCT), and tertiary chorda tendinea (TCT) in left ventricle (LV) - of course, these are only illustrative chordae tendineae ("chords"), and it should be understood that a heart typically has many of each of these different types of chords.

[0028] As shown in FIG. 1A, right ventricle (RV) includes a sub valvular space (105), and left ventricle (LV) includes a subvalvular space (106). The subvalvular space, as used herein, generally includes the portion of the ventricular chamber that is bound peripherally by the ventricular wall (VW), superiorly by the atrio-ventricular valve leaflets, and centrally by the primary chordae tendineae (PCT), and is located along the circumference of the valve annulus. The subannular groove region (104), as used herein, includes the space bordered by the inner surface of the ventricular wall (VW), the inferior surface of valve leaflets (MVL) or (TVL), and the tertiary chordae tendineae (TCT) connected directly to the ventricular wall (VW) and a leaflet. While FIG. 1A shows a subannular groove region (104) in left ventricle (LV), right ventricle (RV) also has a corresponding subannular groove region. Devices and methods described here with respect to the subannular groove region in the left ventricle may, of course, be used on the subannular groove region in the right ventricle, as appropriate. [0029] In some methods, one or more catheters and/or other devices may be used to access one or more regions of a heart. For example, FIG. IB shows a cross-sectional depiction of heart (H) with one variation of a catheter (100) advanced in a retrograde direction through aorta (AO) and into left ventricle (LV) (e.g., after being inserted into the femoral artery). "Retrograde," as used herein, generally refers to a direction opposite the expected flow of blood. This access route may be used to reach subvalvular space (106). The distal portion of the catheter may then be advanced, for example, under the posterolateral mitral valve leaflet and into subannular groove region (104). In some cases, a catheter such as catheter (100) may have one or more curves or bends to enhance its maneuverability and/or positioning within the heart. For example, catheter (100) may include one or more curves or bends toward its distal end (102) to facilitate placement of distal end (102) at the desired location. Curved catheters are described, for example, in U.S. Patent

Application Serial Nos. 12/657,390; 12/690,109; and 12/690,111, all filed on January 19, 2010, each of which is incorporated herein by reference in its entirety.

[0030] Distal end (102) of catheter (100) may be configured to be positioned at an opening into subvalvular space (106) or within subvalvular space (106). This may, for example, allow catheter (100) to be used to deliver one or more devices (e.g., replacement valves) up through mitral valve (MV) (e.g., by passing the device(s) between mitral valve leaflets (MVL)) and into left atrium (LA). Alternatively, it may allow for at least a portion of catheter (100) itself to be relatively easily passed through mitral valve (MV) (e.g., by being passed between mitral valve leaflets (MVL)) and into left atrium (LA). Once positioned in left atrium (LA), catheter (100) may deliver a replacement valve. In certain variations, multiple catheters may be used. For example, a guide catheter and or tunnel catheter (or guide tunnel) may be used to help provide access and or positioning for a replacement valve delivery catheter. Guide catheters and tunnel catheters (or guide tunnels) are described, for example, in U.S. Patent Application Serial Nos. 12/366,553 (published as US 2009/0222083 Al) and 12/657,390; 12/690,109; 12/690,111 (all filed on January 19, 2010), each of which is incorporated herein by reference in its entirety.

[0031] Although the retrograde aortic access route preferably starts from a percutaneous or peripheral access site, in some variations, aortic access may be achieved by an incision in the ascending aorta, descending aorta, aortic arch or iliac arteries, following surgical, thorascopic or laparoscopic access to a body cavity. It should also be noted that access may be obtained through other suitable vessels as well (e.g., the jugular artery). [0032] As discussed above, in some cases, it may be desirable or even necessary to replace a heart valve (e.g., because the heart valve is not functioning properly). FIG. 2 provides a flowchart depiction of one variation of a method (200) for replacing a mitral valve of a heart with a replacement valve. As shown there, method (200) comprises advancing a catheter into a subvalvular space of a heart (210) - here, in the left ventricle of the heart. Next, a distal end of the catheter is positioned beneath the mitral valve, at a commissure of the mitral valve (220). A replacement valve is then advanced from the catheter, between the mitral valve leaflets, and into the left atrium, while the replacement valve is in a closed configuration (230). The closed configuration may, for example, make it easier for the catheter to carry the replacement valve and advance it from one location to another.

[0033] Replacement valves may have any appropriate configuration. For example, the replacement valve to which FIG. 2 refers comprises first and second semiannular frame members, as well as a valve member therebetween. Method (200) comprises securing the first semiannular frame member of the replacement valve to left atrial heart tissue with one or more anchors (240). Of course, while anchors are described here, any other suitable securing mechanism may alternatively or additionally be used with any of the devices, methods and kits described here. Method (200) further comprises converting the replacement valve into an open configuration in the form of a ring comprising the first and second semiannular frame members, with the valve member therebetween (250). Once in its open configuration, the replacement valve has been fully deployed. The second semiannular frame member may then be secured to the left atrial heart tissue with one or more anchors (260), and a tensioning member (here, a tether) that is coupled to the anchors may be tensioned. As a result, the anchors may cinch and thereby compress or tighten the tissue in which they are implanted (270).

[0034] FIGS. 3A-3I provide a more detailed depiction of the method shown in flowchart form in FIG. 2. In FIGS. 3A-3D, 3H and 31, the mitral valve (MV) is depicted

schematically from a superior perspective looking in an inferior direction. As shown there, mitral valve (MV) comprises an anterior leaflet (300), a posterior leaflet (302), a posterolateral commissure (304), an anteromedial commissure (306), and an annulus (316).

[0035] As shown in FIG. 3B, the method comprises positioning the distal end (310) of a catheter (312) beneath mitral valve (MV), at a commissure of mitral valve (MV). Here, distal end (310) is positioned at posterolateral commissure (304), although other locations (e.g., anteromedial commissure (306), or any other location suitable for passage of the replacement valve therethrough) may also be used. Catheter (312) may be positioned as shown using any appropriate technique, such as one of the access routes described herein, or any other appropriate access route. In some cases, a portion of the catheter may be advanced into a space such as the subannular groove region, and/or to one or more other regions of the subvalvular space. Additionally, in certain variations, catheter (312) may be advanced either partially or completely around the circumference of mitral valve (MV).

[0036] Referring still to FIG. 3B, a replacement valve (314) is advanced from catheter (312), between anterior leaflet (300) and posterior leaflet (302) via posterolateral commissure (304), and into the left atrium. During this advancement and passage of the replacement valve, the replacement valve may typically be in a closed configuration, such that it is relatively compact and easy to transport. Of course, while replacement valve (314) is described as being delivered by catheter (312), any appropriate delivery device may be used to advance and deliver a replacement valve. For example, in some cases, a double-lumen cannula may be used to advance and deliver a replacement valve. In FIG. 3B, the curvature of replacement valve (314) in its closed configuration generally aligns with the curvature of annulus (316). In some variations, however, replacement valves having different shapes or configurations may be used, and/or replacement valves may be positioned differently at a target site.

[0037] As shown in FIG. 3B, replacement valve (314) is advanced such that it passes between anterior and posterior leaflets (300) and (302) via posterolateral commissure (304), and into the left atrium, while catheter (312) remains beneath mitral valve (MV). However, other variations of methods may comprise advancing a catheter up through a mitral valve and into the left atrium (e.g., by passing the catheter between the mitral valve leaflets), and then advancing a replacement valve from the catheter once the catheter is positioned at the desired location in the left atrium.

Replacement valves may be advanced from catheters or other delivery devices using any appropriate mechanism. As an example, in some cases, a pushing member may be used. As another example, in certain cases, a cutting member may alternatively or additionally be used to sever one or more connections between the replacement valve and the delivery device (e.g., once the replacement valve has been sufficiently pushed out of the delivery device). It should be understood that while replacement valves may be delivered to a target site using one or more catheters, other types of delivery devices may also be used in some cases.

[0038] Replacement valve (314) comprises a first semiannular frame member (318), a second semiannular frame member (320), and a valve member (322) (FIG. 3D). In FIG. 3C, replacement valve (314) is in its closed configuration and is positioned along annulus (316), with second semiannular frame member (320) adjacent to first semiannular frame member (318) (and, in the depicted view, on top of first semiannular frame member (318), such that first semiannular frame member (318) is hidden). This closed configuration may, for example, allow the replacement valve to be relatively easily advanced toward a target site (e.g., in a catheter). However, other variations of methods may include advancing a replacement valve to a target site in a different manner. For example, some variations of replacement valves may be configured to be rolled up into a catheter or other delivery device for advancement to a target site, and then unrolled upon delivery to the target site. In certain variations, one component of a replacement valve (e.g., a valve member) may be configured to be rolled up in another component of a replacement valve (e.g., a frame member) for advancement to a target site. Once delivered to the target site, the first component may be unrolled out of the second component. In some variations, a replacement valve may be configured to fan out of a delivery device once at a target site. Other variations of replacement valves may be configured to be deployed like a sunshade or an umbrella, for example, or may be configured to be curled up in a delivery device and then uncurled upon reaching a target site.

[0039] FIG. 3C shows the initial deployment of anchors (324) to secure first semiannular frame member (318) (which is underneath second semiannular frame member (320)) to left atrial heart tissue (326). Additional anchors may be deployed as desired, and generally used to help position and secure replacement valve (314) at the target site.

[0040] Anchors may be deployed at a target site using any appropriate devices and methods. For example, and referring again to FIG. 3C, in some variations, first semiannular frame member (318) may be hollow (e.g., first semiannular frame member (318) may have a lumen therethrough). An anchor deployment catheter (not shown) may be advanced through the first semiannular frame member and used to deploy one or more anchors therethrough and into the surrounding left atrial heart tissue. In such variations, at least a portion of first semiannular frame member (318) may be formed of one or more materials which allow for relatively easy deployment of anchors therethrough. For example, at least a portion of first semiannular frame member (318) may comprise one or more polymers (e.g., nylons, PEBAX^® polymers, polyethylenes,

polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (e-PTFE)) and/or polymer blends.

[0041] In certain variations, multiple anchor deployment devices (e.g., catheters) may be used to deploy multiple anchors. At least some of the anchors may be deployed

simultaneously and/or at least some of the anchors may be deployed sequentially. A single anchor deployment device may be used to deploy multiple (at least two) anchors, and/or multiple anchor deployment devices may be used to deploy multiple anchors simultaneously (e.g., at the same location or in different locations).

[0042] In some variations (e.g., some variations in which the anchors are coupled to each other by a tensioning member), first and/or second semiannular frame members (318) and (320) may include wall portions having one or more apertures therethrough. In some such variations, anchors may be deployed through the apertures and into the surrounding tissue.

[0043] In certain variations, a catheter or other component may be used to temporarily stabilize replacement valve (314) prior to and/or during deployment of anchors (324). For example, a tunnel catheter or guide tunnel may be advanced through first semiannular frame member (318) and used to hold the first semiannular frame member in place. In some cases, an anchor deployment catheter may then be advanced through the tunnel catheter and may deploy one or more anchors through one or more apertures in the tunnel catheter. The anchor(s) may pass through the aperture(s) in the tunnel catheter and subsequently through one or more apertures and/or wall portions in the first semiannular frame member. Of course, other variations of devices, methods and kits may also make use of such stabilizing catheters and/or other stabilizing devices.

[0044] Anchors may be deployed from an anchor deployment device in any suitable fashion, including but not limited to using a push-pull wire or a plunger, or any of a variety of other actuation techniques. Exemplary anchor deployment devices, methods and kits are disclosed, for example, in U.S. Patent Application Serial Nos. 11/201,949 (published as US 2007/0055206 Al) and 12/366,553 (published as US 2009/0222083 Al), both of which are incorporated herein by reference in their entirety. Exemplary anchor deployment devices and methods are also disclosed, for example, in U.S. Patent Application Serial No. 12/657,422 (published as US 2010/0198192 Al), which is incorporated herein by reference in its entirety.

[0045] In some variations, anchors may be configured to self-expand as they exit an anchor deployment device, to self-secure into the surrounding tissue, such as annular tissue. In some cases, one or more anchors may be deployed directly into an annulus, while other anchors may be secured to other tissue in the vicinity of the annulus. For example, one or more anchors may be secured to tissue above the annulus. Anchor deployment may be monitored, for example, under X-ray fluoroscopy. Indeed, part or all of a valve replacement procedure may be viewed using one or more imaging methods, such as X-ray fluoroscopy, ultrasound (e.g., intravascular ultrasound, or IVUS), and/or echocardiography (e.g., intracardiac echocardiography). In some variations, one or more of the devices or implants (e.g., catheters, replacement valves, anchors, etc.) described here may comprise one or more radiopaque materials, structures and/or markings to render the devices or implants visible under X-ray fluoroscopy.

[0046] Examples of radiopaque materials include metals, such as gold, silver, titanium and tantalum, and metal alloys, such as Nitinol. Additional examples of radiopaque materials include barium sulfate (BaS0₄) and bismuth trioxide (B1₂O₃). In some cases, radiopaque contrast agent may be used to visualize a procedure. Examples of radiopaque contrast agents include sodium diatrizoate (e.g., HYPAQUE™ contrast medium), sodium meglumine diatrizoate (e.g., RENOGRAFIN-76™ contrast medium), meglumine iothalamate (e.g., CONRAY™ contrast agent), sodium acetrizoate (e.g., UROKON™ contrast medium), iodopyracet (e.g., DIODRAST™ contrast medium), sodium meglumine ioxaglate (e.g., HEXABRIX™ contrast medium), iohexol (e.g., OMNIPAQUE™ contrast agent), and iodixanol (e.g., VISIPAQUE™ contrast medium).

Visualization methods, devices and kits are described, for example, in U.S. Patent Application Serial Nos. 12/657,390; 12/690,109; and 12/690,111, all filed on January 19, 2010, each of which is incorporated herein by reference in its entirety.

[0047] In certain variations, and as discussed in more detail below, anchors may be coupled together with at least one tensioning member. Anchors may be coupled to a tensioning member by any suitable method. For example, anchors may be fixedly coupled to a tensioning member (e.g., using one or more knots, welded regions, and/or adhesives), or may be slidably coupled to a tensioning member. Anchor attachment and deployment methods are described, for example, in U.S. Patent Application Serial Nos. 11/583,627 (published as US 2008/0172035 Al) and 12/505,332 (published as US 2010/0023056 Al), both of which are incorporated herein by reference in their entirety. In some variations, a first anchor that is fixedly coupled to a tensioning member may be deployed from an anchor deployment catheter, and the anchor deployment catheter may then be withdrawn. Thereafter, one or more additional anchor deployment catheters may be advanced over the tensioning member and used to deploy one or more additional anchors that may be slidably coupled to the tensioning member. In this way, the tensioning member may be used to facilitate the insertion of anchor deployment catheters toward the target site. The advancement of catheters over tethers is described, for example, in U.S. Patent Application Serial No. 11/583,627 (published as US 2008/0172035 Al), which is incorporated herein by reference in its entirety. [0048] "Anchors," for the purposes of this application, are defined to mean any fasteners. Thus, the anchors may comprise C-shaped or semicircular hooks, curved hooks of other shapes, straight hooks, barbed hooks, single or multiple loop anchors, clips of any kind, T-tags, rivets, plication elements (e.g., local plication elements such as staples), or any other suitable fastener(s). In one variation, anchors may comprise two tips that curve in opposite directions upon deployment, forming two intersecting semi-circles, circles, ovals, helices or the like. In some variations, the tips may be sharpened or beveled. In certain variations, the anchors may be self- forming. By "self-forming" it is meant that the anchors are biased to change from a first undeployed shape to a second deployed shape upon release of the anchors from a restraint. Such self-forming anchors may change shape as they are released from a housing or deployed from a lumen or opening to enter annular tissue, and secure themselves to the tissue. Self-forming anchors may be made of any appropriate material or materials, such as spring stainless steel, or super-elastic or shape- memory materials such as nickel-titanium alloys (e.g., Nitinol).

[0049] In certain variations, anchors may be made of a non-shape-memory material and may be loaded into an anchor deployment device in such a way that they change shape upon release. For example, anchors that are not self-forming may be secured to tissue via crimping, firing or other application of mechanical force to facilitate tissue penetration and/or securement. Even self- securing anchors may be crimped in some variations, to provide enhanced attachment to tissue. Other types of mechanical force may alternatively or additionally be applied to self-forming anchors. In some variations, anchors may comprise one or more bioactive agents, including biodegradable metals and polymers. In certain variations, a replacement valve may be secured to tissue using multiple self-expanding, non-plicating anchors. In certain variations, a replacement valve may be secured to tissue by one or more T-tag anchors. Some variations of anchors may comprise fibrous or porous materials in the shape of bars, rods, pledgets, or the like. In some cases, the fibrous or porous materials may expand in volume. Additionally, multiple anchors of the same shape may be used, and/or multiple anchors having different shapes or non-uniform implantation sites may be used. Similarly, in some variations, multiple anchors having different sizes may be used. Illustrative examples of anchors and anchor deployment devices and methods are described in more detail, for example, in U.S. Patent Application Serial Nos. 10/741,130 (published as US 2004/0193191 Al); 10/792,681 (published as US 2004/0243227 Al); 10/900,980 (published as US 2005/0107811 Al); 10/901,555 (published as US 2006/0058817 Al); 11/202,474 (published as US 2005/0273138 Al), and 11/255,400 (published as US 2006/0129188 Al), all of which are incorporated herein by reference in their entirety. [0050] FIG. 3D shows replacement valve (314) after it has been deployed into its open configuration. Any appropriate method or mechanism may be used to temporarily keep replacement valve (314) in its closed configuration. For example, first and second semiannular frame members (318) and (320) may be temporarily coupled to each other and the coupling may be severed to convert replacement valve (314) from its closed configuration to its open configuration. Once decoupled, first and second semiannular frame members (318) and (320) may expand away from each other because of shape memory or may, for example, be manually expanded away from each other. Other suitable mechanisms may also be used. The conversion of replacement valve (314) from its closed configuration to its open configuration may occur before, during or after the securing of first semiannular frame member (318) with anchors (324). In its open configuration, replacement valve (314) has a generally circular shape comprising valve member (322) surrounded by first and second semiannular frame members (318) and (320), and may cover a substantial portion, or even the entirety, of the native valve.

[0051] The native valve itself may be manipulated or even partially or entirely resected prior to being replaced with the replacement valve. For example, a native valve may be repositioned or held open during and/or after positioning of a replacement valve (e.g., so that the replacement valve achieves good positioning). In some variations, during and/or after advancement of a delivery device (e.g., a catheter) through a mitral valve, the delivery device may reposition the native mitral valve (e.g., pushing the native mitral valve's leaflets to the side to make room for the replacement valve). In some cases, the new position of the native valve may be set using, for example, one or more securing members, such as anchors. Resection may be achieved, for example, by applying energy (e.g., ultrasonic energy, radiation energy, laser energy and/or heat energy) and/or chemicals to the native valve, and/or by cutting the native valve using one or more cutting members (e.g., a knife, a cutting balloon, etc.).

[0052] As shown in FIG. 3D, replacement valve (314) is a tri-leaflet valve. In other words, valve member (322) comprises three leaflets (328), (330) and (332). However, while FIG. 3D depicts one variation of a replacement valve, any appropriate replacement valve may be used with the devices, methods and kits described here. Examples of replacement valves include mechanical valves, such as single leaflet valves, bi-leaflet valves, tri-leaflet valves, and slit-type valves. In some cases (e.g., some cases involving a bi-leaflet replacement valve), a replacement valve may be attached to one or more chords when the replacement valve is positioned and secured at a target site (e.g., thereby limiting the likelihood of prolapse). Additional examples of replacement valves include bioprosthetic heart valves and tissue valves. In some cases, a tissue valve may comprise engineered tissue. Further examples of replacement valves include pig valves, horse valves, cow valves, and human valves. Replacement valves may have any appropriate size and shape, including but not limited to comprising a disc-shaped or toroidal frame. Any suitable replacement valve may be used in any replacement valve procedure, and a procedure for replacing a particular valve (e.g., a mitral valve) is not necessarily limited to using only one type of replacement valve (e.g., a tri-leaflet replacement valve).

[0053] Replacement valves may comprise any appropriate material or materials, including but not limited to polymers, metals and/or metal alloys. In some variations, one portion or component of a replacement valve (e.g., a frame of the valve) may comprise one type of material (e.g., a metal alloy), while another portion or component of the replacement valve may comprise a different type of material (e.g., a polymer).

[0054] Examples of metals which may be suitable for use in a replacement valve include platinum. Examples of metal alloys which may be suitable for use in a replacement valve include nickel-titanium alloys (e.g., Nitinol), stainless steel and MP35N^® nickel-cobalt-chromium- molybdenum alloy. Other appropriate metals and/or metal alloys may also be used.

[0055] Examples of polymers which may be suitable for use in a replacement valve include polyether-block co-polyamide polymers (e.g., PEBAX^® polyether block amide copolymers, including but not limited to PEBAX^® 35D polymer, PEBAX^® 40D polymer, PEBAX^® 55D polymer, PEBAX^® 63D polymer, and PEBAX^® 72D polymer), copolyester elastomers, thermoset polymers, polyolefins (e.g., polypropylene or polyethylene, including high-density polyethylene (HDPE) and low-density polyethylene (LDPE)), polytetrafluoroethylene (PTFE, such as TEFLON™ polymer), expanded polytetrafluoroethylene (e-PTFE) or other fluorinated polymers, ethylene vinyl acetate copolymers, polyamides (e.g., nylons), polyimides, polyesters (e.g., DACRON^® polymer), polyurethanes (e.g., POLYBLEND™ polymer), polystyrenes, polycarbonates, polyacrylates, vinyl polymers (e.g., polyvinyl chloride or PVC), fluoropolymers (e.g., fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA) polymer, polyvinylidenefluoride (PVDF), etc.), polyetheretherketones (PEEKs), silicones, and copolymers and combinations (e.g., blends) thereof. Examples of polyamides include nylon 6 (e.g., ZYTEL^® HTN high performance polyamides from DuPont™), nylon 11 (e.g., RILSAN^® B polyamides from Arkema Inc.), and nylon 12 (e.g., GRILAMID^® polyamides from EMS-Grivory, RILSAN^® A polyamides from Arkema Inc., and VESTAMID^® polyamides from Degussa Corp.). Additional examples of polymers include bioabsorbable polymers (e.g., polyvinyl alcohol, polylactic acid, polyglycolic acid, polyvinylpyrrolidone, etc.) and biological polymers (e.g., collagen, silk, keratin, etc.). Other polymers and/or non-polymeric materials may also be used in a replacement valve. Moreover, any of the materials (e.g., polymers) that are used in a replacement valve may be combined (e.g., blended), if it is suitable to do so.

[0056] In certain variations, a replacement valve may comprise one or more reinforced polymers or polymer composites (e.g., comprising metals, metal alloys and/or textiles, in the form of particles, meshes, braids, fibers, etc.). In some variations, a replacement valve (e.g., a component of the valve such as a frame member) may comprise one or more ceramics, such as pyrolytic carbon, alumina, graphite or hydroxyapatite. In certain variations, one or more woven or braided materials may be used in a valve. Meshes may also be used, as appropriate. For example, in some cases a valve may comprise a mesh frame.

[0057] In some cases, one or more portions or the entirety of a valve member may be temporarily contained within one or more other components of a replacement valve. The valve member may then be released from the component(s) at the appropriate time. For example, FIGS. 3E-3G depict an exemplary method of deploying leaflet (332) from first semiannular frame member (318) of replacement valve (314). (In FIGS. 3E-3G, second semiannular frame member (320) and valve member leaflets (328) and (330) have been omitted for clarity.) First, FIG. 3E shows first semiannular frame member (318) comprising a wall portion (334) having an elongated aperture (336) formed therein. First semiannular frame member (318) also comprises multiple tabs (338) that temporarily divide elongated aperture (336) into different segments. Referring now to FIG. 3F, when it is desired to deploy leaflet (332), tabs (338) may be actuated (e.g., using a pullwire, etc.) to fully expose elongated aperture (336). As shown in FIG. 3G, leaflet (332) may then be deployed through elongated aperture (336). For example, leaflet (332) may be temporarily held under tension within first semiannular frame member (318) by the presence of tabs (338), and may be released through elongated aperture (336) upon actuation of tabs (338).

[0058] A valve member of a replacement valve may be coupled to one or more other components of the replacement valve (e.g., a valve frame) in any appropriate fashion. For example, a valve member may be sewn, adhesive-bonded, or welded to a valve frame, or may form a snap-fit or interference fit with a valve frame. Any other suitable coupling mechanisms may also be used.

[0059] FIG. 3H shows replacement valve (314) when it has been fully secured to left atrial heart tissue (326) by anchors (324). As shown, anchors (324) secure both first semiannular frame member (318) and second semiannular frame member (320) to left atrial heart tissue (326). Of course, it should be understood that any appropriate securing arrangement may be used. For example, fewer or more anchors may be used, different combinations of anchors may be used, different types of securing members other than anchors may be used, and the like. In some cases, one or more portions of a valve frame or other valve component may be secured to surrounding tissue with anchors, while one or more other portions are secured with different securing members, or are not secured to the surrounding tissue at all.

[0060] As discussed above, in some variations, anchors and/or other securing members may be coupled to each other by at least one tensioning member. For example, FIG. 31 shows anchors (324) coupled to each other by a tensioning member (340). As shown, tensioning member (340) passes through a lumen (344) of first semiannular frame member (318) and a lumen (346) of second semiannular frame member (320). In some variations, tensioning member (340) may be fixedly coupled to at least one of the anchors (e.g., anchor (324')) and slidably coupled to one or more (e.g., all) of the other anchors (e.g., at the location of the anchors' eyelets (342)). As shown in FIG. 31, a portion (347) of tensioning member (340) extends from replacement valve (314). An operator may pull upon portion (347) to cause anchors (324) to cinch toward each other and thereby radially contract the left atrial heart tissue (326) surrounding replacement valve (314). Any other suitable cinching method may also be used. Tensioning members and cinching effects may also be applied to other replacement valve methods and devices, as appropriate. It should also be understood that gathering or compression of tissue may alternatively or additionally be effected in one or more other ways. As an example, in some variations, a replacement valve may be secured (e.g., directly secured) to heart tissue by multiple anchors having one or more shape or position configurations. At the desired time, the anchors may be actuated or otherwise converted to a configuration that results in the surrounding heart tissue being pulled radially inward toward the replacement valve. Other mechanisms and devices may also be used.

[0061] An example of anchor cinching is depicted in additional detail in FIGS. 4A and 4B. First, FIG. 4A shows two anchors (400) and (404) anchored into tissue (406) of a subject. A tensioning member (as shown, a tether (410)) is fixedly attached to anchor (400), and is threaded through a loop region or eyelet (414) of anchor (404). As shown in FIG. 4B, when tether (410) is pulled upon in the direction of arrow (412), a cinching effect results, such that anchors (400) and (404) are brought closer together, and the tissue length between anchors (400) and (404) is reduced. In this way, tissue (406) may be gathered and/or compressed. Tensioning may be effected manually and/or using one or more cinching devices. Non-limiting examples of cinching devices are described in U.S. Patent Application Serial No. 12/576,955 (published as US 2010/0094314 Al), which is incorporated herein by reference in its entirety.

[0062] Referring again to FIG. 31, the radial contraction of tissue provided by pulling on tensioning member (340) may, for example, help to better seat replacement valve (314) and/or to reduce mitral valve regurgitation. In some variations, the function of replacement valve (314) may be monitored by means such as echocardiogram and/or X-ray fluoroscopy, and tensioning member (340) may be tensioned, loosened, and/or adjusted to achieve a desired amount of radial contraction as evident via the employed visualization technique(s). When a desired amount of radial contraction is achieved, tensioning member (340) may be fixed using any of a variety of termination devices and methods, such as a termination catheter. Termination devices and methods are described, for example, in U.S. Patent Application Serial Nos. 11/232,190 (published as US

2006/0190030 Al); 11/270,034 (published as US 2006/0122633 Al); 12/480,568 (published as US 2010/0049213 Al); 12/576,955 (published as US 2010/0094314 Al); and 12/577,044 (filed on October 9, 2009), all of which are incorporated herein by reference in their entirety.

[0063] Tensioning members such as tensioning member (340) may comprise any suitable or desirable biocompatible material, and may be made of a single material or a combination of materials (e.g., a tensioning member may be in the form of one long piece of material, or may comprise two or more pieces). Moreover, tensioning members may be braided or not braided, woven or not woven, and/or reinforced and/or impregnated with one or more additional materials. As non-limiting examples, a tensioning member may be made from (1) a suture material (e.g., absorbable suture materials such as polyglycolic acid and polydioxanone, natural fibers such as silk, and artificial fibers such as polypropylene, polyester, polyester impregnated with

polytetrafluoroethylene, nylon, etc.), (2) a suture-like material, (3) a metal (absorbable or nonabsorbable), (4) a metal alloy (e.g., stainless steel), (5) a shape-memory material, such as a shape- memory alloy (e.g., a nickel-titanium alloy), (6) other biocompatible material, or (7) any

combination thereof. In some variations, a tensioning member may be in the form of a DACRON^® polyester strip. In certain variations, a tensioning member may comprise high-density polyethylene (HDPE), ultra-high molecular weight polyethylene (UHMWPE), and/or polyetheretherketone (PEEK). Some variations of tensioning members may have a braided textile construction. Certain variations of tensioning members may be in the form of a wire. Additionally, a tensioning member may include multiple layers, and/or may include one or more coatings. For example, a tensioning member may be in the form of a polymer-coated wire. In some variations, a tensioning member may comprise a combination of one or more sutures and one or more wires. As an example, a tensioning member may be formed of a suture that is braided with a wire. Certain variations of tensioning members may be in the form of monofilament or multifilament textile yarns or fibers. In some variations, a tensioning member may be formed of one or more electrode materials. In certain variations, a tensioning member may be formed of one or more materials that provide for the telemetry of information (e.g., regarding the condition of the target site). Moreover, some variations of tensioning members, anchors or replacement valves may include one or more therapeutic agents (e.g., drugs, such as time-release drugs).

[0064] FIGS. 3A-3I depict just one variation of a replacement heart valve deployment method, and additional variations of methods, devices and replacement valves may be employed. It should be understood that characteristics or features of any of the devices, methods and kits described here may be applied to other valve replacement devices, methods and kits (whether or not described here), as appropriate.

[0065] FIG. 5 provides a flowchart depiction of another variation of a method (500) for replacing a mitral valve of a heart with a prosthetic valve. As shown there, method (500) comprises advancing a first catheter into a subvalvular space of a heart (510) - here, in the left ventricle of the heart. Next, a distal end of the first catheter is positioned beneath the mitral valve, at a commissure of the mitral valve (520). A replacement valve is then advanced from the first catheter up through the mitral valve commissure (between the mitral valve leaflets) and into the left atrium, while the replacement valve is in a closed configuration (530). The replacement valve to which FIG. 5 refers comprises first and second semiannular rail members, as well as a valve member therebetween. The rail members may, for example, be folded together when the replacement valve is in the closed configuration, and opened away from each other when the replacement valve is in the open configuration. The replacement valve also comprises a valve member that spans between the first and second semiannular rail members when the replacement valve is in the open configuration.

[0066] Referring again to FIG. 5, method (500) further comprises converting the replacement valve into its open configuration (540), and advancing a second catheter up through the mitral valve commissure (between the mitral valve leaflets) and along the first and second seminannular rail members (550). For example, the second catheter may be configured to engage or couple to the first and second semiannular rail members, as explained in further detail below with reference to FIG. 6D. Anchors may then be deployed through the wall of the second catheter (e.g., directly through the wall material and/or through one or more apertures in the wall) to secure the second catheter to surrounding tissue (560). In some cases, a tether or other tensioning member may couple the anchors to each other. In such cases, once the second catheter has been secured, the tether may be tensioned to cinch the anchors and thereby compress or tighten the tissue in which the anchors are implanted (570).

[0067] FIGS. 6A-6H provide a more detailed depiction of the method shown in flowchart form in FIG. 5. First, and referring to FIG. 6 A, a mitral valve (MV) is depicted schematically from a superior perspective looking in an inferior direction. Mitral valve (MV) comprises an anterior leaflet (600), a posterior leaflet (602), a posterolateral commissure (604), an anteromedial commissure (606), and an annulus (608). As shown in FIG. 6B, the distal end (610) of a first catheter (612) is positioned beneath mitral valve (MV), at the location of posterolateral commissure (604). A replacement valve (614) comprising first and second semiannular rail members (616) and (618) (FIG. 6C) is advanced from first catheter (612), up through posterolateral commissure (604) and along the curvature of annulus (608). During this initial advancement, replacement valve (614) is in its closed configuration, with second semiannular rail member (618) adjacent to first semiannular rail member (616) and depicted as positioned on top of first

semiannular rail member (616) in FIG. 6B. Replacement valve (614) also comprises a valve member (620) (FIG. 6C) that may, for example, be temporarily housed within the first and/or second seminannular rail members, or compressed between them in the closed configuration.

[0068] FIG. 6C shows replacement valve (614) in its open configuration, where it has been deployed to cover most of mitral valve (MV). As shown there, replacement valve (614) is a tri-leaflet valve, with valve member (620) comprising three leaflets (622), (624) and (626). When in its open configuration, replacement valve (614) has a generally circular shape, with first and second semiannular rail members (616) and (618) forming an outer border of the circle, and valve member (620) forming the interior of the circle. Of course, replacement valves need not be circular, and may have any of a variety of different shapes depending, for example, on the characteristics of the target site.

[0069] Replacement valve (614) may be converted from its closed configuration to its open configuration by, for example, unlatching a latch or other mechanism that temporarily holds first and second semiannular rail members (616) and (618) together, and pushing against one or both of the rail members to separate them from each other. Alternatively or additionally, the rail members may have shape memory that causes them to expand away from each other once they are removed from the confines of first catheter (612). Other suitable mechanisms, materials and the like may also be used to convert a replacement valve from a closed configuration to an open configuration.

[0070] Next, and referring to FIG. 6D, a second catheter (628) may be advanced up through mitral valve (MV), and along first and/or second semiannular rail members (616) and (618). For example, second catheter (628) may have a groove or slot that aligns with the first and/or second semiannular rail members to engage or couple the second catheter with the rail member(s) and allow the catheter to be tracked along one or both of them. Any appropriate engagement or coupling between a catheter and a rail member or other component of a replacement valve may be employed. For example, FIG. 61 is an illustrative depiction of one variation of a coupling. As shown there, a catheter (650) comprising a lumen (652) defined by a wall portion (654) has engaged a rail member (658) via a notch (660) in wall portion (654). Notch (660) may, for example, be formed along any appropriate length of catheter (650). In some cases, the region of notch (660) may be rendered visible (e.g., radiopaque for visibility under X-ray fluoroscopy), to assist an operator with engaging the notch with the rail member during use. Notch (660) is just one variation of an engagement mechanism, and any other appropriate engagement mechanisms may alternatively or additionally be used, with any suitable component or components of a replacement valve. As an example, in certain variations a catheter may have an open side that is configured to track along a rail member of a replacement valve.

[0071] Referring back again to FIG. 6D, while second catheter (628) here is a different catheter from first catheter (612), in some variations, the same catheter that is used to deliver a replacement valve to a target site may also be tracked along the replacement valve at the target site.

[0072] FIG. 6E shows second catheter (628) after it has been advanced along both first and second semiannular rail members (616) and (618), around the entirety of replacement valve (614). In such a position, second catheter (628) essentially forms a frame of replacement valve (614). In some cases, only a portion of the second catheter may remain at the target site. For example, the second catheter may comprise a detachable distal portion that can be left behind at the target site. The detachable distal portion may, for example, comprise a frangible region or a region comprising a releasable attachment, such as a snap-fit, etc.

[0073] As shown in FIG. 6F, replacement valve (614) may be secured to surrounding left atrial tissue (630) by one or more anchors and/or other securing members. More specifically, FIG. 6F shows anchors (632) that have been deployed through a wall portion of second catheter (628) (e.g., directly through the wall portion, through one or more apertures in the wall portion, etc.). The anchors help to secure replacement valve (614) and may be deployed using, for example, one or more of the anchor deployment devices and methods discussed above, or any other appropriate devices and methods.

[0074] FIG. 6G shows replacement valve (614) after anchors (632) have been deployed around the entirety of its circumference. While FIG. 6G depicts anchors (632) as evenly spaced around the entirety of replacement valve (614), in some variations, anchors and/or other securing members may be positioned along only a portion of the circumference or outer edge of a replacement valve, may be irregularly spaced, etc. Moreover, different combinations of anchors and/or other securing members having different sizes and/or shapes may be used, as discussed above. Additionally, and as shown in FIG. 6H, in some cases, a tensioning element (as shown, a tether (634)) may couple anchors (632) together, and may be tensioned to provide a cinching effect, as also discussed above.

[0075] The above-described methods have included deploying anchors within a catheter or other tubular member to secure the catheter or other tubular member to surrounding tissue. However, other replacement valve securing methods may alternatively or additionally be used. For example, FIG. 7 provides a flowchart depiction of another variation of a method (700) for replacing a mitral valve of a heart with a prosthetic valve. As shown there, method (700) comprises advancing a first catheter into a sub valvular space of a heart (710) - here, in the left ventricle of the heart. Next, a distal end of the first catheter is positioned beneath the mitral valve, at a commissure of the mitral valve (720). A replacement valve is then advanced from the first catheter up through the commissure of the mitral valve (between the mitral valve leaflets) and into the left atrium, while the replacement valve is in a closed configuration (730). Here, the replacement valve comprises first and second semiannular frame members that may, for example, be folded together when the replacement valve is in the closed configuration, and opened away from each other when the replacement valve is in the open configuration. The replacement valve also comprises a valve member that spans between the first and second semiannular frame members when the replacement valve is in the open configuration.

[0076] Referring again to FIG. 7, method (700) further comprises converting the replacement valve into its open configuration (740), and advancing a second catheter up through the commissure of the mitral valve (between the mitral valve leaflets) and adjacent to the first and second seminannular frame members (750). Anchors may then be deployed from the second catheter, such that the anchors engage at least one of the first and second semiannular frame members and the surrounding tissue, thereby anchoring the first and/or second semiannular frame members to the surrounding tissue (760). In some cases, a tether or other tensioning member may couple the anchors to each other. In such cases, the tether may be tensioned to cinch the anchors and thereby compress or tighten the tissue in which the anchors are implanted (770).

[0077] FIGS. 8A-8C provide a more detailed depiction of the method shown in flowchart form in FIG. 7. First, and referring to FIG. 8A, a replacement valve (800) has been positioned over a substantial area of a mitral valve (MV), in the left atrium of the heart, as discussed above. Replacement valve (800) comprises first semiannular frame member (802) and second semiannular frame member (804) (here, joined together to form an outer ring of the replacement valve), as well as a valve member (806) spanning between the first and second semiannular frame members and comprising three leaflets (808), (810) and (812). FIG. 8B shows a catheter (814) being advanced up through the mitral valve (via a commissure (not shown) of the mitral valve) and around an outer circumference of replacement valve (800). As shown in FIG. 8C, catheter (814) is then used to deploy anchors (816) that pierce through second semiannular frame member (804) and into surrounding tissue (818), thereby securing the second semiannular frame member to the tissue. While not shown here, catheter (814) and/or one or more other anchor deployment devices may also be used to deploy one or more additional anchors to secure the replacement valve (e.g., first semiannular frame member (802)) to the surrounding tissue. Additionally, in some cases the anchors may be coupled to each other by at least one tensioning element, such as a tether, which may be tensioned to provide a cinching effect, as discussed above.

[0078] Still other replacement valve deployment methods and devices may be used. For example, FIGS. 9A-9D depict an additional variation of a replacement valve deployment device and associated method.

[0079] First, and referring to FIG. 9A, a catheter (900) is advanced into the left ventricle (LV) of a heart (H). As shown in FIG. 9B, catheter (900) is then advanced from the heart's left ventricle (LV), between the mitral valve leaflets (MVL) of the heart's mitral valve (MV) to pass up through mitral valve (MV), and into the heart's left atrium (LA). Referring now to FIG. 9C, a replacement valve (902) is deployed from a distal end (904) of catheter (900). Of course, while the method depicted here includes deploying the replacement valve from the distal end of the catheter, some variations of methods may comprise deploying a replacement valve from a different location (e.g., through an aperture in a side wall portion of a catheter). When disposed within catheter (900), replacement valve (902) may be closed up and relatively compact. However, and as shown in FIG. 9C, when replacement valve (902) is deployed from catheter (900), replacement valve (902) may expand outwardly and eventually assume its open configuration, depicted in FIG. 9D.

Replacement valve (902) may be deployed from catheter (900) using, for example, a pushing member and/or any other suitable deployment mechanism. Replacement valve (902) may have any appropriate configuration. For example, replacement valve (902) may comprise a collapsible and expandable frame with a valve member therebetween. Moreover, while FIG. 9C depicts replacement valve (902) expanding as it exits catheter (900), in other variations such expansion may occur at any other appropriate time, and may occur incrementally. As an example, in some variations, a replacement valve may be delivered from a catheter and may be expanded only after the replacement valve is fully outside of the catheter and positioned at a target site (e.g., by pulling on a pulling member that expands the valve out).

[0080] FIG. 9D provides an illustrative depiction of the deployed replacement valve (902) in its open configuration, positioned over the native mitral valve (MV). Although not shown here, replacement valve (902) may be secured in its position using, for example, one or more anchors, other securing members, or the like. In some cases, the replacement valve may be secured using anchors that are coupled to each other with a tensioning member. The tensioning member may be tensioned to provide a cinching effect, as discussed above.

[0081] Kits are also described here. In some variations, the kits may include at least one replacement valve and/or at least one replacement valve delivery device (e.g., a catheter). In certain variations, a kit may include multiple (e.g., 2, 3, 4, 5) different replacement valves, such as replacement valves having different shapes and/or sizes. Alternatively or additionally, a kit may include multiple (e.g., 2, 3, 4, 5) different replacement valve delivery devices, such as replacement valve delivery devices having different shapes and/or sizes. In certain variations, a kit may include one or more cinching devices and/or one or more termination devices (e.g., locking devices, cutting devices, or combination locking and cutting devices). Of course, instructions for use may also be provided with the kits.

[0082] While the devices, methods, and kits have been described in some detail here by way of illustration and example, such illustration and example is for purposes of clarity of understanding only. It will be readily apparent to those of ordinary skill in the art in light of the teachings herein that certain changes and modifications may be made thereto without departing from the spirit and scope of the appended claims. As an example, it should be noted that while devices, methods and kits described here may be used to replace a valve, such as a heart valve, in its entirety, in some variations they may be used to assist or repair a native valve. As another example, while certain devices (e.g., catheters, valves) have been described here in conjunction with certain methods, any of the devices, methods, and kits described here may be used independently of each other, or in any suitable combination. As an additional example, in some variations a replacement valve may comprise a tether or other tensioning member that is coupled to a valve member (e.g., comprising one or more valve leaflets), and one or more anchors and/or other securing members may be delivered over the tether to secure the tether and valve member to tissue. In certain variations, the tether may be tensioned to provide a cinching effect, as described above, and may cause the replacement valve to radially contract. As a further example, in some variations, a replacement valve and a separate tether-anchor assembly may both be positioned at a target site. The tether- anchor assembly may be used, for example, to radially contract tissue at the target site toward the replacement valve. While tethers and anchors are described, other types of tensioning members and/or securing members may alternatively or additionally be used.

Claims

CLAIMS What is claimed is:

1. A method comprising:

advancing a first catheter into the left ventricle of a heart so that the first catheter is positioned beneath the mitral valve of the heart;

advancing a replacement valve from the first catheter while the first catheter is in its position beneath the mitral valve of the heart, such that the replacement valve passes between the mitral valve leaflets and up into the left atrium of the heart; and coupling the replacement valve to tissue in the vicinity of the mitral valve.

2. The method of claim 1 , wherein advancing the first catheter into the left ventricle of the heart comprises advancing the first catheter into the vicinity of the subannular groove of the left ventricle.

3. The method of claim 1, wherein the method comprises using at least one anchor to couple the replacement valve to tissue in the vicinity of the mitral valve.

4. The method of claim 3, wherein the method comprises using a plurality of anchors to couple the replacement valve to tissue in the vicinity of the mitral valve.

5. The method of claim 4, wherein the plurality of anchors are coupled to each other by a coupling member.

6. The method of claim 5, wherein the coupling member comprises a tether.

7. The method of claim 5, further comprising tensioning the coupling member.

8. The method of claim 7, wherein tensioning the coupling member cinches the

plurality of anchors.

9. The method of claim 7, wherein tensioning the coupling member radially contracts tissue in the vicinity of the mitral valve.

10. The method of claim 1, further comprising radially contracting tissue in the vicinity of the mitral valve.

11. The method of claim 1 , further comprising radially contracting the replacement valve.

12. The method of claim 1, wherein the replacement valve is coupled to tissue in the vicinity of the mitral valve without expanding the mitral valve.

13. The method of claim 1, wherein the replacement valve comprises first and second frame members that are coupled to each other.

14. The method of claim 13, wherein each of the first and second frame members is semi annular.

15. The method of claim 13, wherein at least one of the first and second frame members is tubular.

16. The method of claim 15, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve comprises advancing a second catheter through at least one of the first and second frame members and deploying at least one anchor through a wall portion of at least one of the first and second frame members, to secure the wall portion to the tissue.

17. The method of claim 16, wherein the first and second catheters are the same catheter.

18. The method of claim 13, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve comprises coupling a second catheter to at least one of the first and second frame members, and advancing the second catheter along at least one of the first and second frame members.

19. The method of claim 18, wherein the first and second catheters are the same catheter.

20. The method of claim 18, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve further comprises deploying at least one anchor through a wall portion of the second catheter and into the tissue.

21. The method of claim 13, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve comprises advancing a second catheter adjacent at least one of the first and second frame members and deploying at least one anchor from the second catheter to couple at least one of the first and second frame members to the tissue.

22. The method of claim 13, wherein the replacement valve has a first configuration in which the first and second frame members are adjacent one another.

23. The method of claim 22, wherein the replacement valve has a second configuration in which the first and second frame members form a ring.

24. The method of claim 13, wherein the replacement valve further comprises a valve leaflet portion coupled to the first and second frame members.

25. The method of claim 24, wherein the valve leaflet portion is disposed within at least one of the first and second frame members when the replacement valve is deployed from the first catheter.

26. The method of claim 25, further comprising deploying the valve leaflet portion from at least one of the first and second frame members.

27. The method of claim 24, wherein the valve leaflet portion comprises two valve leaflets.

28. The method of claim 24, wherein the valve leaflet portion comprises three valve leaflets.

29. The method of claim 1, further comprising repositioning at least one valve leaflet of the mitral valve.

30. A method comprising:

advancing a first catheter into the left ventricle of a heart so that the first catheter is positioned beneath the mitral valve of the heart;

passing the first catheter from its position beneath the mitral valve of the heart between the mitral valve leaflets and up into the left atrium of the heart;

advancing a replacement valve from the first catheter after the first catheter has been advanced into the left atrium of the heart; and

coupling the replacement valve to tissue in the vicinity of the mitral valve.

31. The method of claim 30, wherein advancing the first catheter into the left ventricle of the heart comprises advancing the first catheter into the vicinity of the subannular groove of the left ventricle.

32. The method of claim 30, wherein the method comprises using at least one anchor to couple the replacement valve to tissue in the vicinity of the mitral valve.

33. The method of claim 32, wherein the method comprises using a plurality of anchors to couple the replacement valve to tissue in the vicinity of the mitral valve.

34. The method of claim 33, wherein the plurality of anchors are coupled to each other by a coupling member.

35. The method of claim 34, wherein the coupling member comprises a tether.

36. The method of claim 34, further comprising tensioning the coupling member.

37. The method of claim 36, wherein tensioning the coupling member cinches the

plurality of anchors.

38. The method of claim 36, wherein tensioning the coupling member radially contracts tissue in the vicinity of the mitral valve.

39. The method of claim 30, further comprising radially contracting tissue in the vicinity of the mitral valve.

40. The method of claim 30, further comprising radially contracting the replacement valve.

41. The method of claim 30, wherein the replacement valve is coupled to tissue in the vicinity of the mitral valve without expanding the mitral valve.

42. The method of claim 30, wherein the replacement valve comprises first and second frame members that are coupled to each other.

43. The method of claim 42, wherein each of the first and second frame members is semiannular.

44. The method of claim 42, wherein at least one of the first and second frame members is tubular.

45. The method of claim 44, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve comprises advancing a second catheter through at least one of the first and second frame members and deploying at least one anchor through a wall portion of at least one of the first and second frame members, to secure the wall portion to the tissue.

46. The method of claim 45, wherein the first and second catheters are the same catheter.

47. The method of claim 42, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve comprises coupling a second catheter to at least one of the first and second frame members, and advancing the second catheter along at least one of the first and second frame members.

48. The method of claim 47, wherein the first and second catheters are the same catheter.

49. The method of claim 42, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve further comprises deploying at least one anchor through a wall portion of the second catheter and into the tissue.

50. The method of claim 42, wherein coupling the replacement valve to tissue in the vicinity of the mitral valve comprises advancing a second catheter adjacent at least one of the first and second frame members and deploying at least one anchor from the second catheter to couple at least one of the first and second frame members to the tissue.

51. The method of claim 42, wherein the replacement valve has a first configuration in which the first and second frame members are adjacent one another.

52. The method of claim 51 , wherein the replacement valve has a second configuration in which the first and second frame members form a ring.

53. The method of claim 42, wherein the replacement valve further comprises a valve leaflet portion coupled to the first and second frame members.

54. The method of claim 53, wherein the valve leaflet portion is disposed within at least one of the first and second frame members when the replacement valve is advanced from the first catheter.

55. The method of claim 54, further comprising deploying the valve leaflet portion from at least one of the first and second frame members.

56. The method of claim 53, wherein the valve leaflet portion comprises two valve

leaflets.

57. The method of claim 53, wherein the valve leaflet portion comprises three valve leaflets.

58. The method of claim 30, further comprising repositioning at least one valve leaflet of the mitral valve.