Patent Publication Number: US-2023149161-A1

Title: Epicardial Anchor Devices And Methods

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/790,875, filed Feb. 14, 2020, which is a divisional of U.S. Pat. No. 10,610,354, filed Jan. 20, 2016, which is a continuation under 35 U.S.C. § 120 of International Application No. PCT/US2014/049218, filed Jul. 31, 2014, entitled “Epicardial Anchor Devices and Methods,” which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/861,356, filed Aug.1, 2013, entitled “Pursestring Epicardial Pad Device,” and U.S. Provisional Patent Application No. 61/895,975, filed Oct. 25, 2013, entitled “Improved Epicardial Pad Device,” each of the disclosures of which is incorporated herein by reference in its entirety. International Application No. PCT/US2014/049218 is also a continuation-in-part of U.S. patent application Ser. No. 14/224,764, filed Mar. 25, 2014, entitled “Pursestring Epicardial Pad Device,” which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/861,356, filed Aug. 1, 2013, entitled “Pursestring Epicardial Pad Device,” each of the disclosures of which is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND 
     Embodiments are described herein that relate to devices and methods for anchoring a medical device such as a prosthetic heart valve replacement. 
     Some known devices for anchoring a medical device, such as, for example, a prosthetic heart valve (e.g. mitral valve) can include securing one or more tethers extending from the medical device to body tissue. For example, one or more tethers can extend from a prosthetic heart valve through an opening in the ventricular wall of the heart. Some known methods of anchoring or securing the tethers can include the use of staples or other fasteners that engage or pierce tissue near the puncture site. Such devices can have relatively large profiles and be difficult to easily deliver percutaneously to the desired anchoring site. Some known methods of securing a prosthetic heart valve can include suturing the tethers extending from the valve to body tissue, or tying the suture ends. Such devices and methods can be difficult to maneuver to secure the tether(s) with a desired tension, 
     Further, when an opening is made directly into the ventricular wall or apex of a heart, such as when a prosthetic valve is percutaneously delivered and deployed, in addition to securing the prosthetic valve in a proper position, the efficacy of sealing the puncture site is critical to the life of the patient since hemodynamic losses from a cardiac puncture can cause shock and death within minutes. Further, the outward pressure that the puncture site is subjected to when it is located in the heart muscle itself is much higher than puncture sites that are distal to the heart. Accordingly, improved devices and methods for securing a prosthetic heart valve and for engaging and closing tissue, e.g., to close a cardiac puncture site, would be considered useful to solve these and other problems known in the art. 
     SUMMARY 
     Apparatus and methods for anchoring a prosthetic heart valve are described herein. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a cross-sectional illustration of portion of a heart with a prosthetic mitral valve implanted therein and an epicardial anchor device anchoring the mitral valve in position. 
         FIG.  2    is a schematic illustration of an epicardial anchor device, according to an embodiment. 
         FIG.  3    is a side view of an epicardial anchor device, according to an embodiment. 
         FIG.  4    is an exploded side view of the epicardial anchor device of  FIG.  3   . 
         FIG.  5    is a side view of the epicardial anchor device of  FIG.  3    shown disposed at a spaced distance from a puncture site in an epicardial surface of a ventricular wall and showing a sleeve gasket of the epicardial anchoring device in an uncompressed state or configuration. 
         FIG.  6    is a side view of the epicardial anchor device and ventricular wall of  FIG.  5   , shown with the anchoring device compressed against the puncture site and ventricular wall and the gasket in a compressed state or configuration. 
         FIG.  7    is an exploded side view of an epicardial anchor device, according to another embodiment. 
         FIG.  8    is an exploded side view of an epicardial anchor device, according to another embodiment. 
         FIG.  9    is a top view of a flexible pad that can be included in an epicardial anchor device, according to an embodiment. 
         FIG.  10    is a perspective view of the flexible pad of  FIG.  9    and a portion of a tether disposed therethrough. 
         FIG.  11    is a perspective view of a locking pin and a tether attachment member, according to an embodiment. 
         FIG.  12    is a bottom perspective view of the tether attachment member of  FIG.  11   . 
         FIG.  13    is a top perspective view of a tether attachment member that can be used within an anchor device, according to an embodiment, with a lever arm shown in a first position. 
         FIG.  14    is a cross-sectional perspective view of the tether attachment member of  FIG.  13    with the lever arm shown in the first position. 
         FIG.  15    is a cross-sectional side view of the tether attachment member of  FIG.  13    with the lever arm shown in the first position and a portion of a tether extending through the device. 
         FIG.  16    is a cross-sectional side view of the tether attachment member of  FIG.  13    with the lever arm shown in a second position and a portion of a tether extending through the device. 
         FIG.  17    is a cross-sectional perspective view of a tether attachment member, according to an embodiment, with an access arm of the anchor device shown in a first position and a portion of a tether extending through the device. 
         FIG.  18    is a side-cross-sectional view of the tether attachment member of  FIG.  17    shown with the access arm in the first position and the portion of a tether extending through the device. 
         FIG.  19    is a perspective view of the tether attachment member of  FIG.  17    with a delivery device coupled thereto. 
         FIG.  20    is an enlarged view of the tether attachment member and a portion of the delivery device of  FIG.  19   . 
         FIG.  21    is a top perspective view of the tether attachment member of  FIG.  17    with the access arm shown in a second position. 
         FIG.  22    is a top perspective view of an epicardial anchor device, according to another embodiment. 
         FIG.  23    is a top view of the epicardial anchor device of  FIG.  22   . 
         FIG.  24    is an exploded view of the epicardial anchor device of  FIG.  22   . 
         FIG.  25    is a cross-sectional perspective view of the epicardial anchor device of  FIG.  22    with a locking pin of the device shown in a first position. 
         FIG.  26    is a cross-sectional side view of the epicardial anchor device of  FIG.  20    with the locking pin of the device shown in the first position. 
         FIG.  27    is a cross-sectional bottom perspective view of the epicardial anchor device of  FIG.  22    with the locking pin shown in a second position. 
         FIGS.  28  and  29    are a top perspective and a bottom perspective view, respectively, of a hub member of the epicardial anchor device of  FIG.  22   . 
         FIG.  30    is an enlarged top view of a portion of the pericardial pad device of  FIG.  22   . 
         FIG.  31    is a perspective view of the epicardial anchor device of  FIG.  22    with a delivery device coupled thereto. 
     
    
    
     DETAILED DESCRIPTION 
     Apparatus and methods are described herein that can be used for securing and anchoring a prosthetic heart valve, such as, for example, a prosthetic mitral valve. Apparatus and methods described herein can also be used to close openings through the heart formed for example, when performing a procedure to implant a prosthetic heart valve. Apparatus and methods described herein can also be used to anchor other medical devices and/or to close punctures or openings in other body lumens formed during a diagnostic or therapeutic procedure. 
     In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member. 
     In some embodiments, an apparatus includes a tether attachment member that includes a base member and a lever arm movably coupled to the base member. The base member and the lever arm collectively define a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway and is in fluid communication therewith, and a locking pin is disposed within the locking pin channel. The lever arm is configured to be moved from a first position in which the portion of the tether can be inserted into the tether passageway, and a second position in which the locking pin secures a tether disposed within the tether passageway to the tether attachment member. 
     In some embodiments, an apparatus includes a tether attachment member that includes a base member and a hub member rotatably coupled to the base member. The base member and the hub each define at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway and is in fluid communication therewith and a locking pin is disposed at least partially within the locking pin channel. The hub defines a cam channel in which a driver portion of the locking pin is received. The hub is configured to rotate relative to the base member such that the cam channel moves the locking pin linearly within the locking pin channel moving the locking pin from a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and engages a portion of a tether disposed therein to secure the tether to the tether attachment member. 
     In some embodiments, a method includes inserting into a tether passageway defined by a tether attachment member, a portion of a tether extending from a prosthetic heart valve. The tether attachment member is disposed adjacent an opening in a ventricular wall of a heart from which the tether extends. The tether attachment member is actuated such that a locking pin disposed within a locking pin channel defined by the tether attachment member intersects the tether passageway and engages a portion of the tether disposed within the tether passageway, securing the tether to the tether attachment member. 
     As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof. 
     As used herein, the words “proximal” and “distal” refer to a direction closer to and away from, respectively, an operator of, for example, a medical device. Thus, for example, the end of the medical device closest to the patient&#39;s body (e.g., contacting the patient&#39;s body or disposed within the patient&#39;s body) would be the distal end of the medical device, while the end opposite the distal end and closest to, for example, the user (or hand of the user) of the medical device, would be the proximal end of the medical device. 
     In some embodiments, an epicardial pad system is described herein that can be used to anchor a compressible prosthetic heart valve replacement (e.g., a prosthetic mitral valve), which can be deployed into a closed beating heart using a transcatheter delivery system. Such an adjustable-tether and epicardial pad system can be deployed via a minimally invasive procedure such as, for example, a procedure utilizing the intercostal or subxyphoid space for valve introduction. In such a procedure, the prosthetic valve can be formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the target location, for example, the mitral or tricuspid valve annulus. 
     A compressible prosthetic mitral valve can have a shape, for example that features a tubular stent body that contains leaflets and an atrial cuff. This allows the valve to seat within the mitral annulus and be held by the native mitral leaflets. The use of a flexible valve attached using an apical tether can provide compliance with the motion and geometry of the heart. The geometry and motion of the heart are well-known as exhibiting a complicated biphasic left ventricular deformation with muscle thickening and a sequential twisting motion. The additional use of the apically secured ventricular tether helps maintain the prosthetic valve&#39;s annular position without allowing the valve to migrate, while providing enough tension between the cuff and the atrial trabeculations to reduce, and preferably eliminate, perivalvular leaking. The use of a compliant valve prosthesis and the special shape and features can help reduce or eliminate clotting and hemodynamic issues, including left ventricular outflow tract (LVOT) interference problems. Many known valves are not able to address problems with blood flow and aorta/aortic valve compression issues. 
     Structurally, the prosthetic heart valve can include: a self-expanding tubular frame having a cuff at one end (the atrial end); one or more attachment points to which one or more tethers can be attached, preferably at or near the ventricular end of the valve; and a leaflet assembly that contains the valve leaflets, which can be formed from stabilized tissue or other suitable biological or synthetic material. In one embodiment, the leaflet assembly may include a wire form where a formed wire structure is used in conjunction with stabilized tissue to create a leaflet support structure, which can have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposed therein. In another embodiment, the leaflet assembly can be wireless and use only the stabilized tissue and stent body to provide the leaflet support structure, and which can also have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposed therein. 
     The upper cuff portion may be formed by heat-forming a portion of a tubular nitinol structure (formed from, for example, braided wire or a laser-cut tube) such that the lower portion retains the tubular shape but the upper portion is opened out of the tubular shape and expanded to create a widened collar structure that may be shaped in a variety of functional regular or irregular funnel-like or collar-like shapes. 
     A prosthetic mitral valve can be anchored to the heart at a location external to the heart via one or more tethers coupled to an anchor device, as described herein. For example, the tether(s) can be coupled to the prosthetic mitral valve and extend out of the heart and be secured at an exterior location (e.g., the epicardial surface) with an anchor device, as described herein. An anchor device as described herein can be used with one or more such tethers in other surgical situations where such a tether may be desired to extend from an intraluminal cavity to an external anchoring site. 
       FIG.  1    is a cross-sectional illustration of the left ventricle LV and left atrium LA of a heart having a transcatheter prosthetic mitral valve PMV deployed therein and an epicardial anchor device EAD as described herein securing the prosthetic mitral valve PMV in place.  FIG.  1    illustrates the prosthetic mitral valve PMV seated into the native valve annulus and held there using an atrial cuff AC of the prosthetic mitral valve PMV, the radial tension from the native leaflets, and a ventricular tether T secured with attachment portions Tp to the prosthetic mitral valve PMV and to the epicardial anchor EAD. Various embodiments of an epicardial anchor device are described in more detail below with reference to specific embodiments. 
       FIG.  2    is a schematic illustration of an epicardial anchor device  100  (also referred to herein as “anchor device” or “epicardial anchor”) according to an embodiment. The anchor device  100  can be used to anchor or secure a prosthetic mitral valve PMV deployed between the left atrium and left ventricle of a heart. The anchor device  100  can be used, for example, to anchor or secure the prosthetic mitral valve PMV via a suturing tether  128  as described above with respect to  FIG.  1   . The anchor device  100  can also seal a puncture formed in the ventricular wall (not shown in  FIG.  2   ) of the heart during implantation of the prosthetic mitral valve PMV. The anchor device  100  can also be used in other applications to anchor a medical device (such as any prosthetic atrioventricular valve or other heart valve) and/or to seal an opening such as a puncture. 
     The anchor device  100  can include a pad (or pad assembly)  120 , a tether attachment member  124  and a locking pin  126 . In some embodiments, the anchor device  100  can include a sleeve gasket (not shown in  FIG.  2   ) as described with respect to  FIGS.  3 - 6   . The pad  120  can contact the epicardial surface of the heart and can be constructed of any suitable biocompatible surgical material. The pad  120  can be used to assist the sealing of a surgical puncture formed when implanting a prosthetic mitral valve. In some embodiments, the pad  120  can include a slot that extends radially to an edge of the pad  120  such that the pad  120  can be attached to, or disposed about, the tether  128  by sliding the pad  120  onto the tether  128  via the slot. Such an embodiment is described below with respect to  FIGS.  9  and  10   . 
     In some embodiments, the pad  120  can be made with a double velour material to promote ingrowth of the pad  120  into the puncture site area. For example, pad or felt pledgets can be made of a felted polyester and may be cut to any suitable size or shape, such as those available from Bard® as PTFE Felt Pledgets having a nominal thickness of 2.87 mm. In some embodiments, the pad  120  can be larger in diameter than the tether attachment member  124 . The pad  120  can have a circular or disk shape, or other suitable shapes. 
     The tether attachment member  124  can provide the anchoring and mounting platform to which one or more tethers  128  can be coupled (e.g., tied or pinned). The tether attachment member  124  can include a base member (not shown) that defines at least a portion of a tether passageway (not shown) through which the tether  128  can be received and pass through the tether attachment member  124 , and a locking pin channel (not shown) through which the locking pin  126  can be received. The locking pin channel can be in fluid communication with the tether passageway such that when the locking pin  126  is disposed in the locking pin channel, the locking pin  126  can contact or pierce the tether  128  as it passes through the tether passageway as described in more detail below with reference to specific embodiments. 
     The locking pin  126  can be used to hold the tether  128  in place after the anchor device  100  has been tightened against the ventricular wall and the tether  128  has been pulled to a desired tension. For example, the tether  128  can extend through a hole in the pad  120 , through a hole in a sleeve gasket (if the anchor device includes a sleeve gasket), and through the tether passageway of the tether attachment member  124 . The locking pin  126  can be inserted or moved within the locking pin channel  134  such that it pierces or otherwise engages the tether  128  as the tether  128  extends through the tether passageway of the tether attachment member  124 . Thus, the locking pin  126  can intersect the tether  128  and secure the tether  128  to the tether attachment member  124 . 
     The tether attachment member  124  can be formed with, a variety of suitable biocompatible material. For example, in some embodiments, the tether attachment member  124  can be made of polyethylene, or other hard or semi-hard polymer, and can be covered with a polyester velour to promote ingrowth. In other embodiments, the tether attachment member  124  can be made of metal, such as, for example, Nitinol®, or ceramic materials. The tether attachment member  124  can be various sizes and/or shapes. For example, the tether attachment member  124  can be substantially disk shaped. 
     In some embodiments the tether attachment member  124  can include a lever arm (not shown in  FIG.  2   ) that can be moved between an open position to load the tether  128  within the tether attachment member  124 , and a closed position to secure the tether  128  to the tether attachment member  124 . For example, in some embodiments, when the lever arm is moved to the closed position, the tether passageway is brought into an intersecting relation with the locking pin channel such that the locking pin  126  engages the tether  128  disposed within the tether passageway. In some embodiments, when the lever arm is in the open position, a tool can be used to move the locking pin within the locking pin channel such that the locking pin engages the tether  128  disposed within the tether passageway. In such an embodiment, after the locking pin  126  secures the tether  128 , the lever arm can be moved to the closed position. 
     In some embodiments, the tether attachment member  124  can include a hub that is movably coupled to the base member of tether attachment member  124 . The hub can define a channel that can receive a portion of the locking pin (or locking pin assembly)  126  such that as the hub is rotated, the hub acts as a cam to move the locking pin  126  linearly within the locking pin channel. As with previous embodiments, as the locking pin  126  is moved within the locking pin channel, the locking pin can engage or pierce the tether  128  disposed within the tether passageway and secure the tether  128  to the tether attachment member  124 . Such an embodiment is described herein with respect to  FIGS.  22 - 31   . 
     In use, after a PMV has been placed within a heart, the tether extending from the PMV can be inserted into the tether passageway of the anchor device  100  and the tension on the tether attachment device can be adjusted to a desired tension. Alternatively, in some cases, the tether extending from the PMV can be coupled to the anchor device  100  prior to the PMV being placed within the heart. The anchor device  100  (e.g., some portion of the anchor device such as the tether attachment member  124 , or the lever arm or hub depending on the particular embodiment) can be actuated such that the locking pin  126  intersects the tether passageway and engages a portion of the tether disposed within the tether passageway, securing the tether to the tether attachment member. In some embodiments, prior to inserting the tether into the tether passageway, the anchor device  100  can be actuated to configure the anchor device  100  to receive the tether. For example, if the tether attachment member includes a lever arm movably coupled to the base member, the lever arm may need to be moved to an open position to allow the tether to be inserted. In some embodiments, the anchor device  100  can be actuated by rotating a hub relative to a base member of the tether attachment member  124  such that the locking pin  126  is moved from a first position in which the locking pin is spaced from the tether passageway and a second position in which the locking pin intersects the tether passageway and engages or pierces the portion of the tether. 
     One implementation of the epicardial anchor device  100  is shown in  FIGS.  3 - 6   . An epicardial anchor device  200  (also referred to herein as “anchor device” or “epicardial anchor”) can include a flexible pad  220 , a sleeve gasket  222 , a tether attachment member  224  and a locking pin  226  (shown in  FIG.  4   ). The anchor device  200  can be used to anchor or secure a prosthetic mitral valve (not shown in  FIGS.  3 - 6   ) via a suturing tether  228  shown in  FIGS.  5  and  6   . The anchor device  200  can also seal a puncture  230  formed in the ventricular wall V (see  FIGS.  5  and  6   ) of the heart during implantation of the prosthetic mitral valve. 
     The flexible pad  220  (also referred to herein as “pad”) can contact the epicardial surface of the heart and can be constructed of any suitable biocompatible surgical material. The pad  220  can be used to assist the sealing of a surgical puncture (e.g., puncture  230 ) formed when implanting a prosthetic mitral valve. The pad  220  can be made with the same or similar materials as described above for pad  120 , and can be various sizes and shapes. The pad  220  is shown as having a circular or disk shape, however it should be understood that other suitable shapes can alternatively be used. The pad  220  defines a hole  225  (see  FIGS.  4  and  6   ) through which the tether  228  (shown in  FIGS.  5  and  6   ) can be received as described in more detail below. 
     The sleeve gasket  222  can be disposed between the pad  220  and the tether attachment member  224  and can be used to seal a gap or leakage that may occur between the pad  220  and the tether attachment member  224 . The sleeve gasket  222  can be made of, for example, a flexible material such that it can be compressed when the tether attachment member  224  and/or pad  220  are tightened against the puncture site, e.g. against the ventricular wall. The sleeve gasket  222  may be a separate component coupled to the pad  220  and the tether attachment member  224  or can be formed integrally or monolithically with the pad  220  and/or the tether attachment member  224 . The sleeve gasket  222  can be used to prevent hemodynamic leakage that may flow along the path of the suturing tether  228 . The sleeve gasket  222  can also define a hole (not shown) through which the tether  228  can be received. 
     The tether attachment member  224  can provide the anchoring and mounting platform to which one or more tethers  228  (see  FIGS.  5  and  6   ) may be coupled (e.g., tied). The tether attachment member  224  includes a base member  240  that defines an axial tether passageway  235  through which the tether  228  can be received and pass through the tether attachment member  224 , and a locking pin channel  234  through which the locking pin  226  can be received. The locking pin channel  234  can be in fluid communication with the tether passageway  235  such that when the locking pin  226  is disposed in the locking pin channel  234 , the locking pin  226  can contact the tether  228  as it passes through the tether passageway  235  as described in more detail below. The locking pin  226  can be used to hold the tether  228  in place after the anchor device  200  has been tightened against the ventricular wall V. For example, the tether  228  can extend through the hole  225  of the pad  220 , through the hole (not shown) of the sleeve gasket  222 , and through the tether passageway  235  of the tether attachment member  224 . The locking pin  226  can be inserted through the locking pin channel  234  such that it pierces the tether  228  as the tether  228  extends through the tether passageway  235  of the tether attachment member  224 . Thus, the locking pin  226  can laterally intersect the tether  228  and secure the tether  228  to the tether attachment member  224 . 
     The tether attachment member  224  can be made of any suitable biocompatible material. For example, in some embodiments, the tether attachment member  224  can be made of polyethylene, or other hard or semi-hard polymer, and can be covered with a polyester velour to promote ingrowth. In other embodiments, the tether attachment member  224  can be made of metal, such as, for example, Nitinol®, or ceramic materials. The tether attachment member  224  can be various sizes and/or shapes. For example, the tether attachment member  224  can be substantially disk shaped. 
     In some embodiments, the tether attachment member  224  can be substantially disk shaped and have a diameter between, for example, 1.0-3.0 cm. In other embodiments, the tether attachment member  224  can have a diameter, for example, between 0.2-5.0 cm. For example, a larger size tether attachment member  224  may be desirable to use in, for example, a hernia repair, gastrointestinal repairs, etc. 
     The disk shape of the tether attachment member  224  used to capture and anchor a suture can also be used with little or no trauma to the tissue at the site of the anchor, unlike suture anchors that bore into tissue with screws or barbs. Further, the disk shaped tether attachment member  224  can be easily and quickly slid over the tether  228 , instead of using stitches, which can allow for the effective permanent closure of large punctures. Surgically closing large punctures by sewing can be time consuming and difficult. When closing a puncture in the heart, adding the difficulty of requiring a surgeon to sew the puncture closed can increase the likelihood of life threatening complications to the patient. This is especially so in a situation where a prosthetic heart valve is delivered and deployed without opening the chest cavity using transcatheter technologies. Sewing a ventricular puncture closed in this situation may be undesirable. 
       FIGS.  5  and  6    illustrate the tether  228  extending through the puncture site  230  within a left ventricular wall V of a heart and coupled to the anchor device  200 .  FIG.  5    illustrates the anchor device  200  prior to being tightened against the epicardial surface of the ventricular wall V, and the sleeve gasket  222  in an uncompressed state or configuration. The tether  228  can optionally be wound around the tether attachment member  224  to further improve anchoring. 
       FIG.  6    illustrates the anchor device  200  tightened against the epicardial surface of the ventricular wall V. As shown in  FIG.  6   , the anchor device  200  can be compressed against the puncture site  230  and contact the epicardial surface. An end portion  232  (shown in  FIG.  5   ) of the tether  228  can be trimmed after the tether  228  has been secured to the tether attachment member  224  or after the anchor device  200  has been secured against the epicardial surface. 
       FIG.  7    illustrates an embodiment of an epicardial anchor device  300  (also referred to herein as “anchor device” or “epicardial anchor”) that is similar to the anchor device  200  except the anchor device  300  does not include a sleeve gasket (e.g., sleeve gasket  222  described above). The anchor device  300  can include a flexible pad  320 , a tether attachment member  324  and a locking pin  326 , which can be configured the same as or similar to the flexible pad  220 , the tether attachment member  224  and the locking pin  226 , respectively, described above. The anchor device  300  can be used the same as or similar to anchor device  200  to secure a prosthetic mitral valve (not shown) via a suturing tether (not shown). The anchor device  300  may be desirable to use, for example, when an anti-leakage sleeve is unnecessary to prevent hemodynamic leakage that may flow along the path of the suturing tether. 
       FIG.  8    illustrates an embodiment of an epicardial anchor device  400  (also referred to herein as “anchor device” or “epicardial anchor”) that is similar to the anchor device  200  and the anchor device  300  except the anchor device  400  does not include a pad (e.g., pads  220  and  320 ). The anchor device  400  can include a tether attachment member  424 , a sleeve gasket  422  and a locking pin  426 , which can be configured the same as or similar to the tether attachment member  224 , the sleeve gasket  222  and the locking pin  226 , respectively, described above. The anchor device  400  can be used to anchor or secure a prosthetic mitral valve (not shown) via a tether (not shown) in the same or similar manner as described above for previous embodiments. The anchor device  400  may be desirable to use, for example, when a flexible pad is unnecessary, for example, when the tether is moved to a new location. In such a case, the ventricular puncture would be small (e.g., a small diameter) and may not require the pad for bleeding control. 
       FIGS.  9  and  10    illustrate an embodiment of a pad  520  that can be included in an epicardial anchor device as described herein. The pad  520  defines an axial hole  525  and a slot  537  that communicates with hole  525 . The slot  537  extends radially to an outer edge of the pad  520  such that the pad  520  can be disposed about or removed from a tether  528  (see  FIG.  10   ) without sliding the pad  520  down the length of tether  528 . For example, the pad  520  can be disposed about the tether  528  by laterally sliding the pad  520  from the side such that the tether is inserted into the slot  537  and positioned within the opening  525  of the pad  520 . The pad  520  can be secured to the tether with, for example, pins, clamps, etc. 
     To remove the pad  520 , the pad  520  can similarly slide off from the side, for example, outside of the apex of the ventricle of the heart. Thus, the pad  520  can be removed without removing the entire anchor device. The pad  520  can be formed with the same or similar materials as described above for previous embodiments (e.g., pad  220 ,  320 ,  420 ), and can be used to close a puncture site (e.g., in a ventricular wall) as described above. 
     The pad  520  can also enable the use of an introducer sheath at the apex, which would limit the amount of motion and passes through the apex. For example, when the sheath is pulled back, a slotted pad  520  can be slid in from the side allowing control of the tether tension during sheath removal. The pad  520  with slot  537  can also be used independent of a sheath as described above. 
       FIGS.  11  and  12    illustrate an embodiment of a tether attachment member  624  that can be included within an anchor device as described herein. Various features described herein for tether attachment member  624  can also be included in the tether attachment members described herein for other embodiments (e.g.,  124 ,  224 ,  324 ,  424 ). As described above, a locking pin  626  (shown in  FIG.  11   ) can be used to secure a tether/suture to the tether attachment member  624  in a similar manner as described above for previous embodiments. 
     The tether attachment member  624  is shown having a disk shape and can include a base member  640  that defines a winding channel  632 , an axial tether passageway  635 , radial channels  633 , and a locking pin channel  634  through which the locking pin  626  can be received. The base member  640  also defines a proximal opening  615  and a distal opening  617  each communicating with the tether passageway  835 . The base member  640  can include a chamfered edge or lead-in portion  627  at the proximal opening  615 , and a chamfered edge or lead-in portion  629  at the distal opening  617  to allow a suture (e.g., tether) to be easily threaded into the tether passageway  635  and reduce lateral cutting force of the tether attachment member  624  against the suture. The radial channels  633  can allow a user to quickly capture and seat a tether (not shown) that is intended to be anchored. The winding channel  632  can allow a user to quickly wind tether(s) around tether attachment member  624 . The use of winding channel  632  with radial channel(s)  633  can allow a user to quickly anchor the tether while permitting the user to unwind and recalibrate the anchor device to adjust the tension on the tether (not shown) as appropriate for a particular use. 
       FIGS.  13 - 16    illustrate a portion of another embodiment of an epicardial anchor device  700 . The epicardial anchor device  700  includes a tether attachment member  724  and a flexible pad or fabric member (not shown in  FIGS.  13 - 16   ). The tether attachment member  724  includes a base member  740  that defines a locking pin channel  734  that can receive therein a locking pin  726  in a similar manner as described above for previous embodiments and a circumferential pad channel  742 . The pad channel  742  can be used to secure the flexible pad or fabric member (not shown in  FIGS.  13 - 16   ) of the epicardial anchor device  700  to the tether attachment member  724 . For example, the flexible pad can be disposed on a distal end portion of the tether attachment member  724  such that when the anchor device  700  is secured to a ventricular wall as described above for previous embodiments, the flexible pad contacts the ventricular wall. 
     The tether attachment member  724  also defines tether passageway  735  through which a tether  728  (see, e.g.,  FIGS.  15  and  16   ) can be received, and a proximal opening  715  and a distal opening  717  each in communication with the tether passageway  735 . A chamfered edge or lead-in portion  729  is included at or near the distal opening  717  to allow a tether  728  (see e.g.,  FIGS.  15  and  16   ) to be easily threaded into the tether passageway  735  and reduce lateral cutting force of the tether attachment member  724  against the tether  728 . 
     A lever arm  738  is coupled to the base member  740  that collectively with the base member  740  defines a tether passageway  735 . The lever arm  738  can be moved between a first position, as shown in  FIG.  16   , in which the lever arm  738  is biased by a spring member  739  into a down position, and a second position, as shown in  FIGS.  13 - 15   , in which the lever arm  738  is placed in an extended position to allow the tether  728  to be placed within the tether passageway  735 . For example, the lever arm  738  can be rotated in the direction of arrow A shown in  FIG.  15    to move the lever arm  738  to its second or extended position. In some cases, a suture or cord can be used to pull the lever arm  738  to the extended second position. 
     When in the first position, as shown, for example, in  FIGS.  14  and  15   , a tip of the locking pin  726  is disposed at a spaced distance from the lever arm  738  and the tether passageway  735 . When the locking pin  726  is spaced from the tether passageway  735 , the tether  728  can be inserted into the tether passageway  735  as shown in  FIG.  15   . The tether  728  can then be tightened to a desired tension and the lever arm can then be released such that it is biased back to the first position, as shown in  FIG.  16   . When the lever arm  738  is moved (e.g., biased) to the first position, and with the tether  728  extending through the tether passageway  735 , the locking pin  726  pierces or intersects with the tether  728  and the tip of the locking pin is then disposed within a cavity  736  defined by the lever arm  738  securing the tether  728  to the tether attachment member  724 . 
       FIGS.  17 - 21    illustrate a portion of another embodiment of an epicardial anchor device  800  that includes a tether attachment member  824  and a flexible pad or fabric member (not shown in  FIGS.  17 - 21   ). The tether attachment member  824  includes a base member  840  and a lever arm  838  pivotally coupled to the base member  840 . The base member  840  defines a circumferential pad channel  842  in which the flexible pad can be coupled to the tether attachment member  824 . For example, the flexible pad can be disposed on a distal end portion of the tether attachment member  824  such that when the anchor device  800  is secured to a ventricular wall as described above for previous embodiments, the flexible pad contacts the ventricular wall. 
     The lever arm  838  and the base member  840  collectively define a tether passageway  835  through which a tether  828  can be received, as shown in  FIG.  17   . The base member  840  also defines a distal opening  817  and an opening  815  each in fluid communication with the tether passageway  835 . The tether  828  can be inserted through the distal opening  817  (the side to be implanted closest to the ventricular wall) and extend through a portion of the tether passageway  835  defined by the base member  840 , and through a portion of the tether passageway  835  defined by the lever arm  838 , and exit the opening  815 . As with previous embodiments, the base member  840  includes a chamfered edge or lead-in portion  829  at the distal opening  817  of the tether passageway  835  to allow the tether  828  to be easily threaded into the tether passageway  835  and reduce lateral cutting force of the tether attachment member  824  against the tether  828 . 
     The lever arm  838  defines a locking pin channel  844  in which a locking pin  826  can be movably disposed. The locking pin  826  includes a driver portion  846  and a piercing portion  849 . As shown in  FIGS.  17  and  18   , the locking pin channel  844  includes portions with varying diameters in which the driver portion  846  of the locking pin  826  can be movably disposed. For example, the driver portion  846  can be threadably coupled to the inner walls of the locking pin channel  844  such that the locking pin  826  can be moved between a first position, shown in  FIG.  17   , in which the driver portion  846  is disposed within a portion  839  of the locking pin channel  844  and the piercing portion  849  is spaced from the tether passageway  835 , and a second position in which the driver portion  846  is disposed within a portion  845  (shown in  FIGS.  17  and  18   ) of the locking pin channel  834 , and the piercing portion  849  extends through the tether passageway  835 , engaging or piercing the tether  828 . The lever arm  838  also defines an opening  847  that communicates with the locking pin channel  844  and can receive a driving tool that can be used to move the locking pin  826  within the locking pin channel  844  as described in more detail below. 
     The lever arm  838  can be moved (e.g., rotated, pivoted) between a first or open position, as shown, for example, in  FIGS.  17  and  18   , in which the lever arm  838  extends in a proximal direction from the base member  840 , and a second or closed position as shown in  FIG.  21   , in which a proximal surface  819  of the lever arm  838  is substantially flush with a proximal surface  821  of the base member  840 . When the lever arm  838  is in the first or open position, a delivery tool  848  can be coupled to the lever arm  828  as shown in  FIGS.  19  and  20   . The delivery tool  848  can include a driver  849  shown in  FIG.  18    (e.g., a screw driver) that can engage the driver portion  846  of the locking pin  826  to move the locking pin  826  within the locking pin channel  834 . 
     In operation, the tether  828  can be inserted into the tether passageway  835  and extend out of the opening  815  and within the delivery tool  848 . The tether  828  can then be tightened to a desired tension. With the tether  828  at the desired tension, the driver  849  of the delivery tool  848  can then move the locking pin  826  from the first position, as shown in  FIG.  17    to the second position in which the piercing portion  849  pierces or engages the tether  828 , securing the tether  828  to the tether attachment member  824 . For example, the driver  849  of the delivery tool  848  can threadably move the locking pin  826  from the first position to the second position. After the tether  828  is secured to the tether attachment member  824 , the delivery tool  849  can be removed and the lever arm  838  can be moved to the second or closed position as shown in  FIG.  21   . 
       FIGS.  22 - 30    illustrate an epicardial anchor device according to another embodiment. An epicardial anchor device  900  includes a tether attachment member  924 , a pad assembly  920 , a tube member  955  and a tube cover member  956 . The tether attachment member  924  includes a base member  940 , a hub  950 , a retaining ring  952 , a locking pin assembly  926 , and a pin member  953 . The locking pin assembly  926  includes a driver portion  946  and a piercing portion  949 . The base member  940  defines a circumferential pad channel  942 , a retaining channel  951  and a locking pin channel  934 . The pad channel  942  can be used to couple the pad assembly  920  to the tether attachment member  924 . The retaining channel  951  can receive an outer edge of the retaining ring  952 , which is used to retain the hub  950  to the base member  940 . The base member  940  also defines cutouts or detents  943 , as shown for example, in  FIGS.  23 ,  25  and  30   . 
     The tube member  955  is coupled to the base member  940  and the base member  940 , the hub  950  and the tube member  955  collectively define a tether passageway  935  through which a tether (not shown) can be received. The cover member  956  can be formed with a fabric material, such as for example, Dacron®. The tether channel  935  intersects the locking pin channel  934  and is in fluid communication therewith. 
     The pad assembly  920  includes a top pad portion  958 , a bottom pad portion  959  and a filler member  957  disposed therebetween. The top pad portion  958  and the bottom pad portion  959  can each be formed with, for example, a flexible fabric material. The top pad portion  958  and the bottom pad portion  959  can each define a central opening through which the tube member  955  can pass through. A portion of the top pad portion  958  is received within the channel  942  of the base member  940  as shown, for example, in  FIGS.  25 - 27   . 
     An outer perimeter portion of the hub  950  is received within the retaining channel  951  such that the hub  950  can rotate relative to the base member  940  to actuate the locking pin assembly  926  as described in more detail below. As shown, for example, in  FIGS.  28  and  29   , the hub  950  includes arms  961  with protrusions  962 . The protrusions  962  can be received within cutouts  943  of the base member  940  and act as a stop or limit to the rotation of the hub  950 . The slots  963  defined by the hub  950  enable the arms  961  to flex and allow the protrusions  962  to be moved in and out of the cutouts  943 . As shown, for example, in  FIGS.  27  and  29    the hub  950  defines a curved channel  950  on a bottom portion of the hub  950 . The curved channel  950  is asymmetrical (or spiral) and receives the driver portion  946  of the locking pin assembly  926 . As the hub  950  is rotated relative to the base member  940 , the hub  950  acts as a cam to move the locking pin assembly  926  linearly within the locking pin channel  934 . The locking pin assembly  926  can be moved from a first position in which the piercing portion  949  is disposed outside of the tether passageway  935  as shown in  FIGS.  25  and  26   , and a second position in which the piercing portion  949  extends through the tether passageway  935  as shown in  FIG.  27   . The pin member  953  (see, e.g.,  FIG.  26   ) can be formed with a metal material that is more radio-opaque than the other components of the anchor device and thus visible to the user (e.g. physician) using conventional imaging modalities to enable the user to confirm that the locking pin assembly  926  has been fully moved to the second position. 
     In use, when the locking pin assembly  926  is in the first position, a tether (not shown) coupled to, for example, a prosthetic mitral valve and extending through a puncture site in the ventricular wall of a heart can be inserted through the tether passageway  935 . The hub  950  can then be rotated  180  degrees to move the locking pin assembly  926  linearly within the locking pin channel  934  such that the piercing portion  949  extends through the tether passageway  935  and engages or pierces the tether, securing the tether to the tether attachment member  924 . For example, when the locking pin is in the first position, the protrusions  962  of the hub  950  are each disposed within one of the cutouts  943  of the base member  940  (i.e., a first protrusion is in a first cutout, and a second protrusion is in a second cutout). The hub  950  can then be rotated 180 degrees such that the protrusions  962  are moved out of the cutouts  943  of the base member  940  and at the end of the  180  degrees the protrusions  962  are moved into the other of the cutouts  943  of the base member  940  (i.e., the first protrusion is now in the second cutout, the second protrusion is now in the first cutout). 
     The base member  940  can also include cutout sections  966  and define side openings  967  (see, e.g.,  FIGS.  22  and  23   ) that can be used to couple a delivery device to the epicardial anchor device  900 . For example,  FIG.  31    illustrates a delivery device  948  having coupling arms  968  and coupling pins (not shown) extending inwardly from the arms  968 . The side openings  967  can receive the coupling pins and the cutout sections  966  can be engaged by the coupling arms  968 . 
     While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above 
     Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.