Pericardial anchor system

Abstract

Various aspects of the present disclosure are directed to devices, systems and methods for fixation of cardiac devices, and more particularly, for accessing and fixating the pericardial space.

Description

[Technical field]

[0001] INCORPORATION BY REFERENCE TO PRIORITY APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 182,727, filed April 30, 2021, and U.S. Provisional Application No. 63 / 179,490, filed April 25, 2021, each of which is incorporated by reference in its entirety for all purposes.

[0002] Any foreign or domestic priority claim identified in the PCT application filed with this application is hereby incorporated by reference.

[0003] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to cardiac device fixation, and more particularly to apparatus, systems and methods involving accessing and fixation in the pericardial space. [Background technology]

[0004] background There is a need to anchor medical devices within cardiac chambers. Typically, these devices may have anchors that are implanted into the myocardium. There remains a need for safer anchoring systems for such devices. Summary of the Invention

[0005] Abstract The described embodiments are directed to devices, systems and methods for pericardial fixation.

[0006] According to one example ("Example 1"), an anchor system includes an anchor and a tether coupled to the anchor, the anchor operable to have a low profile in a first position and a larger profile in a second position, the anchor operable to advance from a chamber of the heart through a narrow access channel in a heart wall at the first position into a pericardial space and to expand within the pericardial space to a second position to a size larger than the narrow access channel.

[0007] According to another example ("Example 2"), a fixation method includes advancing a guidewire into the heart up to and adjacent to a heart wall, advancing a needle catheter over the guidewire through the endocardium of the heart wall and into the myocardium, advancing the guidewire through the needle catheter through the myocardium and through the epicardium (the visceral plate of the serous pericardium) and into the pericardial cavity, withdrawing the needle catheter from the guidewire, advancing a catheter over the guidewire into the pericardial cavity, separating the pericardium from the heart wall to enlarge the pericardial cavity, advancing an anchoring system over the guidewire or through the catheter, where a portion of the anchoring system is disposed within the pericardial cavity, deploying anchors of the anchoring system within the pericardial cavity and positioning the anchors against the epicardium, and removing the guidewire and / or catheter from the patient leaving a tether coupled to the anchor in the heart chamber.

[0008] According to another example ("Example 3"), a fixation method includes advancing a guidewire into a femoral vein, advancing the guidewire through the femoral vein and into the right atrium, advancing the guidewire through the septum and into the left atrium, advancing the guidewire through the mitral valve adjacent to the heart wall to the heart wall of the left ventricle, advancing a needle catheter over the guidewire through the endocardium and into the myocardium of the heart wall, advancing the guidewire through the needle catheter, through the myocardium, through the epicardium and into the pericardial space, withdrawing the needle catheter from the guidewire, advancing a catheter over the guidewire into the pericardial space, inflating the pericardium to separate it from the heart wall to enlarge the pericardial space, advancing an anchoring system over the guidewire or through the catheter, where a portion of the anchoring system is disposed within the pericardial space, deploying anchors of the anchoring system within the pericardial space and positioning the anchors against the epicardium, and removing the guidewire and / or catheter from the patient to leave a tether coupled to the anchors within the heart space.

[0009] According to another example ("Example 4"), a fixation method includes advancing a guidewire into a needle catheter such that the distal tip of the guidewire is adjacent to the distal tip of the needle catheter, advancing the distal tip of the needle catheter from a heart chamber through the endocardium of the heart wall and into the myocardium, advancing the distal tip of the guidewire through the myocardium and epicardium and into the pericardial cavity, and advancing an anchor of an anchor system over the guidewire into the pericardial cavity.

[0010] According to another example ("Example 5"), the fixation method includes optionally advancing an optional support catheter into the heart to, adjacent to, or against the heart wall; advancing an anchor catheter alone or through the optional support catheter to forcibly engage or be placed adjacent to the heart wall; advancing a guidewire through the anchor catheter and through the endocardium, myocardium, epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial cavity; advancing over the guidewire through the endocardium, through the myocardium, through the epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial cavity. , optionally withdrawing the guidewire from the pericardial space; optionally separating the pericardium from the epicardium to enlarge the pericardial space; advancing or exposing an anchor of an anchor system through or near a distal end of an anchor catheter within the pericardial space, where the anchor is positioned within the pericardial space; deploying the anchor of the anchor system within the pericardial space and positioning the anchor against the epicardium; and removing the guidewire and / or anchor catheter and / or support catheter from the patient, leaving a tether coupled to the anchor within the heart cavity.

[0011] According to another example ("Example 6"), a method of fixation includes advancing an anchor catheter within a heart chamber near or against a wall of the heart, advancing a guidewire through the anchor catheter such that a distal tip of the guidewire passes through the endocardium into the myocardium, through the epicardium and into the pericardial space, and advancing a distal tip of the anchor catheter along or over the guidewire into or adjacent to the pericardial space, advancing or exposing an anchor of an anchor system through or at a distal end of the anchor catheter that is within the pericardial space, where the anchor is positioned within the pericardial space, deploying an anchor of the anchor system within the pericardial space and positioning the anchor against the epicardium, and removing the guidewire and / or anchor catheter from the patient, leaving a tether coupled to the anchor within the heart chamber of the anchor system on the guidewire within the pericardial space.

[0012] According to another example ("Example 7"), a mitral valve chordae tendineae repair system includes a pericardial anchor system including an epicardial anchor including a skirt, a transmyocardial pledget, a pericardial anchor suture coupled to the epicardial anchor and the transmyocardial pledget, a suture lock, and an anchor socket configured to restrain and dock the suture lock, the epicardial anchor configured to be transformable between a pre-deployed configuration and a deployed configuration, and further including at least one leaflet anchor coupled to a leaflet anchor suture, the suture lock configured to secure the pericardial anchor suture and the leaflet anchor suture.

[0013] According to another example ("Example 8"), in the mitral valve chordae tendineae repair system of Example 7, the epicardial anchor is configured to form a disk shape in the deployed configuration.

[0014] According to another example ("Example 9"), in the mitral valve chordae tendineae repair system of Example 7, the epicardial anchor is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployed configuration.

[0015] According to another example ("Example 10"), in the mitral valve chordae repair system of Example 7, the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a compressed configuration.

[0016] According to another example ("Example 11"), in the mitral valve chordae repair system of Example 7, the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a coiled configuration.

[0017] According to another example ("Example 12"), in the mitral valve chordae tendineae repair system of Example 7, the epicardial anchor has a free end in a pre-deployed configuration, and the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form a deployed configuration.

[0018] According to another example ("Example 13"), in the mitral valve chordae tendineae repair system of Example 7, the epicardial anchor further includes a wire frame, the wire frame being covered by the skirt.

[0019] According to another example ("Example 14"), in the mitral valve chordae tendineae repair system of Example 13, the wire frame of the epicardial anchor has shape memory properties that are shape-set in a deployed configuration.

[0020] According to another example ("Example 15"), in the mitral valve chordae tendineae repair system of Example 13, the skirt is configured to slidably receive the pericardial anchor suture, and the pericardial anchor suture is operable to be tensioned to tighten the skirt in the deployed configuration.

[0021] According to another example ("Example 16"), in the mitral valve chordae tendineae repair system of Example 13, the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, the skirt including a plurality of apertures along an edge of the skirt opposite the wire frame, the pericardial anchor sutures are woven alternately through the plurality of apertures, and the pericardial anchor sutures are operable to be tensioned to tighten the skirt in a deployed configuration.

[0022] According to another example ("Example 17"), in the mitral valve chordae tendineae repair system of Example 13, the wire frame of the epicardial anchor further includes a proximal leg, which is configured to be straight and centrally located on the epicardial anchor in the deployed configuration.

[0023] According to another example ("Example 18"), in the mitral valve chordae tendineae repair system of Example 17, the transmyocardial pledget extends from a proximal leg of the epicardial anchor.

[0024] According to another example ("Example 19"), in the mitral valve chordae tendineae repair system of Example 17, the proximal leg includes two portions of the same wire doubled so that the two portions are parallel to each other.

[0025] According to another example ("Example 20"), in the mitral valve chordae tendineae repair system of Example 7, the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, by proximal retraction of the pericardial anchor suture.

[0026] According to another example ("Example 21"), in the mitral valve chordae tendineae repair system of Example 13, the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, due to a shape memory property of a wire frame that is shaped into the deployed configuration.

[0027] According to another example ("Example 22"), in the mitral valve chordae repair system of Example 7, the first end of the wire frame and the second end of the wire frame each include an atraumatic end.

[0028] According to another example ("Example 23"), in the mitral valve chord repair system of Example 7, the transmyocardial pledget comprises a film having a tubular structure.

[0029] According to another example ("Example 24"), in the mitral valve chordae tendineae repair system of Example 23, the pericardial anchor sutures are woven through a plurality of apertures through the transmyocardial pledget film.

[0030] According to another example ("Example 25"), in the mitral valve chordae repair system of Example 7, the anchor socket includes a self-expanding frame covered with a film.

[0031] According to another example ("Example 26"), a pericardial anchor system includes an epicardial anchor including a skirt, a transmyocardial pledget extending from a proximal portion of the epicardial anchor, a pericardial anchor suture coupled to the epicardial anchor and the transmyocardial pledget, a suture lock configured to secure the pericardial anchor suture, and an anchor socket configured to restrain and dock the suture lock, wherein the epicardial anchor is configured to be transformable between a pre-deployed configuration and a deployed configuration.

[0032] According to another example ("Example 27"), the pericardial anchor system of Example 26, wherein the epicardial anchor is configured to form a disk shape in the deployed configuration.

[0033] According to another example ("Example 28"), in the pericardial anchor system of Example 26, the epicardial anchor is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployed configuration.

[0034] According to another example ("Example 29"), in the pericardial anchor system of Example 26, the pre-deployed configuration includes an elongated configuration and the deployed configuration includes a compressed configuration.

[0035] According to another example ("Example 30"), in the pericardial anchor system of Example 26, the pre-deployed configuration includes an elongated configuration and the deployed configuration includes a coiled configuration.

[0036] According to another example ("Example 31"), in the pericardial anchor system of Example 26, the epicardial anchor has a free end in a pre-deployed configuration, and the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form a deployed configuration.

[0037] According to another example ("Example 32"), in the pericardial anchor system of Example 26, the epicardial anchor further includes a wire frame, the wire frame being covered by a skirt.

[0038] According to another example ("Example 33"), in the pericardial anchor system of Example 32, the wire frame of the epicardial anchor has shape memory properties that are shaped into a deployed configuration.

[0039] According to another example ("Example 34"), in the pericardial anchor system of Example 26, the skirt is configured to slidably receive the pericardial anchor suture, and the pericardial anchor suture is operable to be tensioned to tighten the skirt in the deployed configuration.

[0040] According to another example ("Example 35"), in the pericardial anchor system of Example 32, the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, the skirt including a plurality of apertures along an edge of the skirt opposite the wire frame, the pericardial anchor sutures are woven alternately through the plurality of apertures, and the pericardial anchor sutures are operable to be tensioned to tighten the skirt in the deployed configuration.

[0041] According to another example ("Example 36"), in the pericardial anchor system of Example 32, the wire frame of the epicardial anchor further includes a proximal leg, the proximal leg being configured to be straight and centrally located in the epicardial anchor in the deployed configuration.

[0042] According to another example ("Example 37"), in the pericardial anchor system of Example 36, the transmyocardial pledget extends from a proximal leg of the epicardial anchor.

[0043] According to another example ("Example 38"), in the pericardial anchor system of Example 36, the proximal leg includes two portions of the same wire that are doubled so that the two portions are parallel to each other.

[0044] According to another example ("Example 39"), in the pericardial anchor system of Example 36, the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, by proximal retraction of the pericardial anchor suture.

[0045] According to another example ("Example 40"), in the pericardial anchor system of Example 32, the epicardial anchor is transformable between the pre-deployed configuration and the deployed configuration, at least in part, due to a shape memory property of a wire frame that is shaped into the deployed configuration.

[0046] According to another example ("Example 41"), in the pericardial anchor system of Example 32, the first end of the wire frame and the second end of the wire frame each include an atraumatic end.

[0047] According to another example ("Example 42"), in the pericardial anchor system of Example 41, the atraumatic end of each of the first end of the wire frame and the second end of the wire frame includes an eyelet.

[0048] According to another example ("Example 43"), in the pericardial anchor system of Example 26, the transmyocardial pledget comprises a film having a tubular structure.

[0049] According to another example ("Example 44"), in the pericardial anchor system of Example 43, the pericardial anchor sutures are woven through a plurality of apertures through the transmyocardial pledget film.

[0050] According to another example ("Example 45"), an epicardial anchor includes a skirt and a pericardial anchor suture coupled to the skirt, the epicardial anchor configured to be transformable between a pre-deployed configuration and a deployed configuration.

[0051] According to another example ("Example 46"), the epicardial anchor of Example 45, wherein the epicardial anchor is configured to form a disk shape in the deployed configuration.

[0052] According to another example ("Example 47"), the epicardial anchor of Example 45, wherein the epicardial anchor is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployed configuration.

[0053] According to another example ("Example 48"), the epicardial anchor of Example 45, the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a compressed configuration.

[0054] According to another example ("Example 49"), the epicardial anchor of Example 45, wherein the pre-deployed configuration comprises an elongate configuration and the deployed configuration comprises a coiled configuration.

[0055] According to another example ("Example 50"), in the epicardial anchor of Example 45, the epicardial anchor has a free end in a pre-deployed configuration, and the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form a deployed configuration.

[0056] According to another example ("Example 51"), in the epicardial anchor of Example 45, the epicardial anchor further includes a wire frame, the wire frame being covered by the skirt.

[0057] According to another example ("Example 52"), in the epicardial anchor of Example 45, the wire frame of the epicardial anchor has shape memory properties that are shaped into a deployed configuration.

[0058] According to another example ("Example 53"), in the epicardial anchor of Example 51, the skirt is configured to slidably receive the pericardial anchor suture, and the pericardial anchor suture is operable to be tensioned to tighten the skirt in the deployed configuration.

[0059] According to another example ("Example 54"), in the epicardial anchor of Example 51, the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, the skirt including a plurality of apertures along an edge of the skirt opposite the wire frame, the pericardial anchor sutures are woven alternately through the plurality of apertures, and the pericardial anchor sutures are operable to be tensioned to tighten the skirt in the deployed configuration.

[0060] According to another example ("Example 55"), in the epicardial anchor of Example 51, the wire frame of the epicardial anchor further includes a proximal leg, which is configured to be straight and centrally located in the epicardial anchor in the deployed configuration.

[0061] According to another example ("Example 56"), in the epicardial anchor of Example 55, the proximal leg includes two portions of the same wire doubled so that the two portions are parallel to each other.

[0062] According to another example ("Example 57"), in the epicardial anchor of Example 55, the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, by proximal retraction of the pericardial anchor suture.

[0063] According to another example ("Example 58"), in the epicardial anchor of Example 51, the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, due to a shape memory property of a wire frame that is shaped into the deployed configuration.

[0064] According to another example ("Example 59"), in the epicardial anchor of Example 51, the first end of the wire frame and the second end of the wire frame each include an atraumatic end.

[0065] According to another example ("Example 60"), in the epicardial anchor of Example 64, the atraumatic end of each of the first end of the wire frame and the second end of the wire frame includes an eyelet.

[0066] According to another example ("Example 61"), a method of securing a pericardial anchor system includes advancing an epicardial anchor in a pre-deployed configuration constrained within an anchor catheter into a pericardial space of a heart, advancing the anchor catheter tangentially within the pericardial space a predetermined distance to desheath the epicardial anchor in the pre-deployed configuration, and retracting the anchor catheter to at least partially deploy the epicardial anchor within the pericardial space to a deployed configuration.

[0067] According to another example ("Example 62"), in the method of fastening the pericardial anchor system of Example 61, the predetermined distance comprises at least 10 cm.

[0068] According to another example ("Example 63"), in a method of fixing the pericardial anchor system of Example 61, the anchor catheter is configured to move in an inner-outer direction and / or an inferior-superior direction within the pericardial cavity.

[0069] According to another example ("Example 64"), the method of fixing the pericardial anchor system of Example 61 further includes disposing a proximal leg of the epicardial anchor between the epicardium and the distal tip of the anchor catheter to maintain the position of the epicardial anchor within the pericardial cavity.

[0070] According to another example ("Example 65"), the method of securing the pericardial anchor system of Example 61 further includes applying tension to a pericardial anchor suture of the pericardial anchor system to at least partially transform the epicardial anchor into a deployed configuration.

[0071] According to another example ("Example 66"), in a method of fixing the pericardial anchor system of Example 61, the epicardial anchor is further transformed to a deployed configuration, at least in part, due to a shape memory property of a wire frame of the epicardial anchor that is shaped into the deployed configuration.

[0072] According to another example ("Example 67"), a method of securing a pericardial anchor system includes advancing a support sheath against a heart wall within a heart chamber to a heart wall; advancing a guidewire through the support sheath such that a distal tip of the guidewire is advanced through the endocardium, myocardium, and epicardium and into the pericardial space; advancing an anchor sheath and a guidewire sheath together through the support sheath and over the guidewire into the pericardial space to form a puncture through the endocardium, myocardium, and epicardium; maintaining the position of the guidewire sheath while retracting the anchor sheath and the support sheath together to deploy an epicardial anchor of the pericardial anchor system within the pericardial space, where the epicardial anchor is supported by the anchor sheath. the anchor sheath is in a pre-deployed configuration while positioned within a support sheath, while maintaining the position of the anchor sheath to form a T-bar between a proximal leg of a wire frame of the epicardial anchor and a distal tip of the anchor sheath; retracting the support sheath, the anchor sheath and the guidewire sheath together until the proximal leg is positioned against the epicardial puncture; maintaining the position of the guidewire sheath and retracting the anchor sheath and the support sheath together to deploy the epicardial anchor; and applying tension to pericardial anchor sutures of the pericardial anchor system to transform the epicardial anchor at least partially to a deployed configuration.

[0073] According to another example ("Example 68"), in the method of fixing the pericardial anchor system of Example 67, the epicardial anchor is further transformed into the deployed configuration, at least in part, due to the shape memory properties of the wire frame that is shaped into the deployed configuration.

[0074] According to another example ("Example 69"), the method of securing the pericardial anchor system of Example 67 further includes maintaining the position of the guidewire sheath and retracting the support sheath and the anchor sheath to deploy a transmyocardial pledget and anchor socket of the pericardial anchor system, wherein a first portion of the transmyocardial pledget is positioned within the epicardial, myocardial and endocardial puncture and a second portion of the transmyocardial pledget extends proximally from the endocardial puncture.

[0075] According to another example ("Example 70"), the method of anchoring the pericardial anchor system of Example 67 further comprises folding a second portion of the transmyocardial pledget against the endocardial puncture.

[0076] According to another example ("Example 71"), the method of securing the pericardial anchor system of Example 67 further includes advancing a suture lock into the anchor socket and advancing the suture lock within the anchor socket toward the endocardium to fold a second portion of the transmyocardial pledget.

[0077] According to another example ("Example 72"), in the method of anchoring the pericardial anchor system of Example 68, the film covered proximal leg of the epicardial anchor is configured to seal an epicardial puncture, a first portion of the transmyocardial pledget is configured to seal a myocardial puncture, and a folded second portion of the transmyocardial pledget is configured to seal an endocardial puncture. According to one embodiment, a pericardial access and fixation tool (herein referred to as tool) is provided operatively deployed within the myocardium and extending from the ventricular side of the heart into the pericardial cavity.

[0078] According to another example ("Example 73"), a tool for placement in the heart wall and pericardial cavity operable to provide access from a heart chamber to the pericardial cavity and / or operable to be an anchor for an associated device includes a body defining a lumen operable to extend through the heart wall, a head at a distal end of the body operable to extend into the pericardial cavity, the head including a movable element operable to move from a low profile pre-deployed configuration to a high profile deployed configuration, the head defining an eyelet in fluid communication with the lumen to define an access channel operable to provide a fluid passage between the heart chamber and the pericardial cavity, and a base further including a retention member operable to retain the base to the heart wall.

[0079] According to another example ("Example 74"), in the tool of Example 73, the movable element is operable to support the parietal pericardium when the movable member reaches a high profile in the deployed configuration, and the retaining member cooperates to abut and engage the movable element against the parietal pericardium.

[0080] According to another example ("Example 75"), in the tool of Examples 73 and 74 and the tool of Examples 1 and 2, the movable element includes an expansion member operable to abut the pericardium to enlarge the pericardial cavity.

[0081] According to another example ("Example 76"), in the tool of Examples 73 and 74, the eyelet is operable to evacuate or extract fluid or gas from the pericardial cavity using a device in communication with the lumen.

[0082] According to another example ("Example 77"), in the tool of Example 73, the eyelet is operable to be a pressure port operable to measure pressure with a pressure sensing device.

[0083] According to another example ("Example 78"), in the tool of any of Examples 73-77, the access channel is operable to receive a device and enable passage of the device between the ventricular side of the heart and the pericardial cavity.

[0084] According to another example ("Example 79"), in any of the tools of Examples 73 to 77, the eyelet is operable to elastically deform between an open configuration and a closed configuration, wherein in the closed configuration, the access channel is blocked to prevent the passage of fluid through the access channel.

[0085] According to another example ("Example 80"), in the tool of any of Examples 73 to 77, the head further includes an obstruction element operable to move elastically between an open position and a closed position, wherein in the closed position, the access channel is obstructed to prevent the passage of fluid through the access channel.

[0086] According to another example ("Example 81"), the tool of any of Examples 73-77 further includes an obstruction plug operable to be positioned within the access channel to obstruct the access channel and prevent fluid passage therethrough.

[0087] According to another example ("Example 82"), the tool of any of Examples 73-77, wherein the tool is operable to couple to another device or cardiac tissue.

[0088] According to another example ("Example 83"), a method of implanting a tool of any one of Examples 69-82 includes providing a delivery system operable for endovascular epicardial access, wherein the delivery system includes a steerable catheter and a delivery catheter, inserting the delivery system into a patient using a transvenous, transarterial, transseptal, transatrial or transaortic approach, advancing the delivery catheter having the tool associated therewith into the myocardium, and extending the head of the tool into the pericardial cavity.

[0089] According to another example ("Example 84"), in a method of implanting the tool of Example 83, the delivery system further includes a guidewire and / or needle, and the method includes advancing a guidewire or needle through the delivery catheter and extending the tool through the myocardium and into the pericardial cavity and advancing the tool over the guidewire or needle.

[0090] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any of the inventive concepts provided by the present disclosure. [Brief description of the drawings]

[0091] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0092] [Figure 1A] FIG. 1A is a side view of an anchoring system according to one embodiment.

[0093] [Figure 1B] FIG. 1B is a side view of the anchor system of FIG. 1A.

[0094] [Figure 2A] FIG. 2A is a cross-sectional view of the heart.

[0095] [Figure 2B] FIG. 2B is an enlarged cross-sectional view of the heart of FIG. 2A.

[0096] [Diagram 3] FIG. 3 is a cross-sectional view of a heart with a guidewire according to one embodiment of a method of providing a pericardial anchoring system.

[0097] [Figure 4]FIG. 4 is a cross-sectional view of a heart with a guidewire according to one embodiment of a method of providing a pericardial anchoring system.

[0098] [Figure 5A] FIG. 5A is a cross-sectional view of a heart with a guidewire according to one embodiment of a method of providing a pericardial anchoring system.

[0099] [Figure 5B] FIG. 5B is a cross-sectional view of a heart with a guidewire according to one embodiment of a method of providing a pericardial anchoring system.

[0100] [Figure 6] FIG. 6 is a cross-sectional view of a heart with a guidewire and needle catheter, according to one embodiment of a method of providing a pericardial anchoring system.

[0101] [Figure 7] FIG. 7 is a cross-sectional view of a heart with a guidewire and needle catheter, according to one embodiment of a method of providing a pericardial anchoring system.

[0102] [Figure 8] FIG. 8 is a cross-sectional view of a heart with a guidewire and a catheter, according to one embodiment of a method of providing a pericardial anchoring system.

[0103] [Figure 9] FIG. 9 is a cross-sectional view of a heart with a catheter and anchoring system, according to one embodiment of a method of providing a pericardial anchoring system.

[0104] [Figure 10] FIG. 10 is a cross-sectional view of a heart with a deployed catheter and anchoring system, according to one embodiment of a method of providing a pericardial anchoring system.

[0105] [Figure 11]FIG. 11 is a cross-sectional view of a heart with a deployed anchoring system, according to one embodiment of a method of providing a pericardial anchoring system.

[0106] [Figure 12] FIG. 12 is a cross-sectional view of a heart with an anchoring system deployed along with a sealing means, according to one embodiment of a method of providing a pericardial anchoring system.

[0107] [Figure 13] FIG. 13 is a cross-sectional view of a heart with an anchoring system deployed with a tether lock, according to one embodiment of a method of providing a pericardial anchoring system.

[0108] [Figure 14] FIG. 14 is a cross-sectional view of a heart with a deployed anchoring system coupled to the mitral valve leaflets to prevent prolapse, according to one embodiment of a method of providing a pericardial anchoring system.

[0109] [Figure 15] FIG. 15 is a flow diagram of one embodiment of a method of providing a pericardial anchor system.

[0110] [Figure 16] FIG. 16 is a flow diagram of one embodiment of a method of providing a pericardial anchor system.

[0111] [Figure 17] FIG. 17 is a flow diagram of one embodiment of a method of providing a pericardial anchor system.

[0112] [Figure 18] FIG. 18 is a top view of the anchor system in a pre-deployed configuration with the wire and skirt in a straight configuration according to one embodiment.

[0113] [Figure 19]FIG. 19 is a plan view of the anchoring system in a deployed configuration, with the wire and skirt in a ring configuration, according to the embodiment of FIG.

[0114] [Figure 20] FIG. 20 is a perspective cross-sectional view of an anchor system deployed within the pericardial space, with the anchor positioned against the epicardium and the tether passing through the endocardium, in accordance with the embodiment of FIGS. 18 and 19, and further including an optional tether lock on the opposite side of the endocardium.

[0115] [Figure 21] FIG. 21 is an example of a pericardial anchor system in an expanded configuration, according to one embodiment.

[0116] [Figure 22] FIG. 22 is an example of the pericardial anchor system of FIG. 21, where the epicardial anchor is in a deployed configuration and the transmyocardial pledget is in a pre-deployed configuration.

[0117] [Diagram 23] FIG. 23 is an example of the pericardial anchor system of FIGS. 21 and 22 in a fully deployed configuration.

[0118] [Figure 24] FIG. 24 is a wireframe example of an epicardial anchor in a deployed configuration, according to one embodiment.

[0119] [Figure 25A] FIG. 25A is an example of a pericardial anchor system with a suture lock, according to one embodiment.

[0120] [Figure 25B] FIG. 25B is an example of a pericardial anchor system with a T-bar epicardial anchor, according to one embodiment.

[0121] [Figure 26A]FIG. 26A is an example of a pericardial anchor system with a frameless epicardial anchor, according to one embodiment.

[0122] [Figure 26B] FIG. 26B is an example of a pericardial anchor system with a T-bar and a frameless epicardial anchor, according to one embodiment.

[0123] [Figure 27] FIG. 27 is an example of a pericardial anchor system and a leaflet anchor system deployed and implanted within the heart, according to one embodiment.

[0124] [Figure 28A] FIG. 28A is an example of a leaflet anchor implanted in the leaflet and leaflet anchor sutures extending between the leaflet anchor and a pericardial anchor system implanted in the ventricular wall, according to one embodiment.

[0125] [Figure 28B] FIG. 28B is a cross-sectional view of a ventricular wall with an implanted pericardial anchor system, according to one embodiment.

[0126] [Figure 28C] FIG. 28C is an illustration of an epicardial anchor implanted within the pericardial space (pericardium not shown for clarity), according to one embodiment.

[0127] [Figure 29] FIG. 29 is an example of a delivery subsystem for a pericardial anchor system in a first configuration, according to one embodiment.

[0128] [Diagram 30] FIG. 30 is an example of a delivery subsystem for the pericardial anchor system of FIG. 29 in a second configuration.

[0129] [Diagram 31]FIG. 31 is an example of a guidewire sheath of a delivery subsystem for the pericardial anchor system of FIGS. 29 and 30, according to one embodiment.

[0130] [Diagram 32] FIG. 32 is an example of a delivery subsystem with a pericardial anchor system, according to one embodiment.

[0131] [Diagram 33] FIG. 33 is a cross-sectional view of a heart with a delivery catheter according to one embodiment of a method of providing a pericardial anchoring system.

[0132] [Diagram 34] FIG. 34 is a cross-sectional view of a heart with a delivery subsystem for a pericardial anchoring system, according to one embodiment of a method of providing the pericardial anchoring system.

[0133] [Diagram 35] FIG. 35 is a cross-sectional view of a heart wall with a support sheath of a delivery subsystem according to one embodiment of a method of providing a pericardial anchoring system.

[0134] [Diagram 36] FIG. 36 is a cross-sectional view of the heart wall with a guidewire of a delivery subsystem according to one embodiment of a method of providing a pericardial anchoring system.

[0135] [Figure 37A] FIG. 37A is a cross-sectional view of a heart wall with an anchor sheath according to one embodiment of a method of providing a pericardial anchor system.

[0136] [Figure 37B] FIG. 37B is a cross-sectional view of a heart with an anchor sheath according to one embodiment of a method of providing a pericardial anchoring system.

[0137] [Figure 38] FIG. 38 is a cross-sectional view of the heart wall with an anchor sheath partially retracted for delivery of the pericardial anchor system, according to one embodiment of a method of providing the pericardial anchor system.

[0138] [Figure 39] FIG. 39 is a cross-sectional view of the heart wall with an anchor sheath partially retracted to deliver the pericardial anchor system, according to one embodiment of a method of providing the pericardial anchor system.

[0139] [Diagram 40] FIG. 40 is a cross-sectional view of the heart wall with the guidewire sheath retracted to deliver the pericardial anchoring system, according to one embodiment of a method of providing the pericardial anchoring system.

[0140] [Diagram 41] FIG. 41 is a cross-sectional view of a heart wall with an implanted pericardial anchor system, according to one embodiment of a method of providing the pericardial anchor system.

[0141] [Diagram 42] FIG. 42 is a cross-sectional view of a heart with a delivery subsystem for a leaflet anchoring system, according to one embodiment of a method of providing the leaflet anchoring system.

[0142] [Diagram 43] FIG. 43 is a cross-sectional view of a heart with a needle according to one embodiment of a method of providing a leaflet anchoring system.

[0143] [Diagram 44] FIG. 44 is a cross-sectional view of a heart with leaflet anchors according to one embodiment of a method of providing a leaflet anchor system.

[0144] [Diagram 45]FIG. 45 is a cross-sectional view of a heart with leaflet anchors according to one embodiment of a method of providing a leaflet anchor system.

[0145] [Diagram 46] FIG. 46 is a cross-sectional view of a heart with the delivery subsystem for the leaflet anchoring system withdrawn.

[0146] [Figure 47] FIG. 47 is a cross-sectional view of a heart with a delivery subsystem for a suture lock.

[0147] [Figure 48A] FIG. 48A is a cross-sectional view of a heart with a suture lock positioned within an anchor socket of a pericardial anchor system.

[0148] [Figure 48B] FIG. 48B is a cross-sectional view of the heart wall with a suture lock positioned within the anchor socket of the pericardial anchor system.

[0149] [Figure 49A] FIG. 49A is a cross-sectional view of a heart with the anchor socket of the pericardial anchor system positioned against the heart wall.

[0150] [Figure 49B] FIG. 49B is a cross-sectional view of a heart wall with a pericardial anchor system.

[0151] [Figure 50] FIG. 50 is a cross-sectional view of a heart with a suture cutter.

[0152] [Figure 51] FIG. 51 is a cross-sectional view of the heart with the suture cutters withdrawn.

[0153] [Figure 52] FIG. 52 is a cross-sectional view of the heart with the delivery catheter withdrawn.

[0154] [Figure 53A] FIG. 53A is a cross-sectional view of a heart with multiple leaflet anchors.

[0155] [Figure 53B] FIG. 53B is a cross-sectional view of a heart with multiple leaflet anchor sutures.

[0156] [Fig. 54A-54B] 54A and 54B are side and cross-sectional views, respectively, of a tool according to one embodiment.

[0157] [Fig. 54C] FIG. 54C is a cross-sectional view of the left ventricle and mitral valve leaflets showing a steerable guide catheter for tool placement.

[0158] [Fig. 54D] FIG. 54D is a cross-sectional view of the left ventricle showing the distal end of the steerable guide catheter.

[0159] [Figure 55A] FIG. 55A is a cross-sectional view of the heart showing a delivery system positioned adjacent to the endocardium, according to one embodiment.

[0160] [Figure 55B] FIG. 55B is a cross-sectional view of the heart showing a tool traversing the endocardium and myocardium with the aid of a needle for placement in the myocardial and pericardial cavities during the deployment process, according to one embodiment.

[0161] [Figure 55C] FIG. 55C is a cross-sectional view of the heart showing the tool traversing the epicardium for placement within the myocardium and pericardial cavity during the deployment process, according to one embodiment.

[0162] [Fig. 55D]FIG. 55D is a cross-sectional view of the heart showing a tool enlarging the pericardial cavity during the deployment process, according to one embodiment.

[0163] [Figure 55E] FIG. 55E is a cross-sectional view of the heart showing the moveable elements of the tool that enlarge the pericardial space during the deployment process, according to one embodiment.

[0164] [Fig. 55F] FIG. 55F is a cross-sectional view of the heart showing movable elements of the tool engaging the epicardium and / or pericardium to secure the tool within the pericardial space, according to one embodiment.

[0165] [Figure 55G] FIG. 55G is a cross-sectional view of the heart showing moveable elements of the tool engaging the epicardium and / or pericardium to secure the tool within the pericardial space, according to one embodiment.

[0166] [Fig. 55H] FIG. 55H is a top view of the head showing the arrangement of the movable elements in the deployed configuration, according to one embodiment.

[0167] [Fig. 55I] FIG. 55I is a cross-sectional view of a heart showing the tool positioned in a deployed configuration within the myocardium and pericardial cavity, according to one embodiment.

[0168] [Fig. 56A1-A2] 56A1 and 56A2 are top and side views, respectively, of a tool head with a moveable element according to one embodiment.

[0169] [Figure 56A3] FIG. 56A3 is a side view of a tool head with moveable elements according to one embodiment.

[0170] [Figure 56A4] FIG. 56A4 is a side view of a tool head with moveable elements according to one embodiment.

[0171] [Fig. 56B1] FIG. 56B1 is a top view of a tool head with moveable elements according to one embodiment.

[0172] [Fig. 56B2] FIG. 56B2 is a top view of a tool head with moveable elements according to one embodiment.

[0173] [Fig. 56B3] FIG. 56B3 is a top view of a tool head with a moveable element, according to one embodiment.

[0174] [Fig. 56B4] FIG. 56B4 is a top view of a tool head with moveable elements according to one embodiment.

[0175] [Fig. 56C1] FIG. 56C1 is a top view of a tool head with a moveable element according to one embodiment.

[0176] [Figure 56C2] FIG. 56C2 is a top view of a tool head with moveable elements according to one embodiment.

[0177] [Fig. 56C3] FIG. 56C3 is a top view of a tool head with a moveable element, according to one embodiment.

[0178] [Fig. 56C4] FIG. 56C4 is a top view of a tool head with moveable elements according to one embodiment.

[0179] [Fig. 56D1] FIG. 56D1 is a side view of a tool head with moveable elements, according to one embodiment.

[0180] [Fig. 56D2] FIG. 56D2 is a side view of a tool head with moveable elements according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0181] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0182] The embodiments herein may be described in conjunction with various principles and beliefs, but the described embodiments should not be bound by theory. For example, the embodiments are described herein in conjunction with preventing prolapse of mitral valve leaflets with an anchoring system contained within the pericardial space. However, the embodiments within the scope of the present disclosure may be applied to any prosthesis or mechanism of similar structure and / or function that requires anchoring within a cardiac chamber.

[0183] The embodiments herein include various devices, systems and methods for sutures or other tether mechanisms with anchors located within the pericardial space, where the sutures extend through the myocardium and endocardium and are used to connect with biological elements such as mitral valve leaflets, or prostheses such as, but not limited to, sensors or support structures. The anchors within and adjacent to the epicardium (visceral plate of the serous pericardium) can be any suitable structure, such as, but not limited to, umbrella elements, pledgets, multi-legged support structures. The anchors have a low profile so that they can pass through narrow access channels in the heart wall, and are operable to expand or deploy to a larger diameter or surface area within the pericardial space and not pass through narrow access channels in the heart structures. The present disclosure relates to the repair or replacement of the mitral valve, and more generally to methods and devices for the remodeling, repair and / or replacement of the mitral valve chordae, also referred to as chordae tendineae, to restore proper function of the mitral valve from dysfunctional conditions such as, but not limited to, mitral regurgitation.

[0184] The term "heart wall" as used herein is defined as the endocardium, myocardium and epicardium.

[0185] The terms "pericardial space" and "pericardial cavity" as used herein are the space defined by the heart wall and the pericardium, or the space between the visceral and parietal pericardium.

[0186] The term "coupled," as used herein, means coupled, connected, attached, attached, affixed, or adhered, whether directly or indirectly, and permanently or temporarily.

[0187] According to an embodiment, as provided in FIG. 17, pericardial fixation is provided by a small hollow needle catheter (e.g., 20-25 gauge) and a compatible guidewire (e.g., 0.010 inch to 0.018 inch operable to fit into the lumen of the needle catheter). Passage through the heart wall from within the heart chamber is initiated by passing the needle catheter through the endocardium and into the myocardium, and completed by passing the guidewire through the remainder of the myocardium and the epicardium. The guidewire is positioned within the pericardial space such that anchors of the anchoring system are subsequently delivered over the guidewire into the pericardial space.

[0188] Because the profile is extremely small, the risk of adverse events, such as reduced risk of pericardial effusion / tamponade, may be reduced.

[0189] Using a guidewire instead of a needle catheter to cross the epicardium not only improves safety but also improves ease of use of the procedure by eliminating the guesswork / ambiguity of, for example, not going too short or too far into the pericardial space due to the difficulty of imaging and / or knowing placement within the pericardial space. For example, the selection of the guidewire stiffness is optimized both at the distal tip and along its entire length so that the distal tip is stiff enough to cross the remainder of the heart wall and enter the pericardial space, but soft enough not to flex and puncture the pericardium (serous pericardium and parietal plate of fibrous pericardium). The guidewire is operable to coil within the pericardial space and track within the pericardial space. Advancement of the distal end of the guidewire within the pericardial space adjacent to the heart wall can provide evidence to the clinician that the distal end of the guidewire is within the pericardial space.

[0190] If the outer diameter of the guidewire is slightly smaller than the inner diameter of the needle, the possibility of gouging the heart wall is mitigated or minimized to reduce tissue trauma. The needle catheter and guidewire may be introduced together, i.e., nested or in tandem, with the guidewire distal tip pulled back slightly relative to the needle catheter distal tip. After the needle catheter punctures the endocardium, the guidewire may be advanced beyond the distal tip of the needle catheter, with the needle catheter supporting the guidewire.

[0191] It is understood that there are different ways to advance the small hollow needle catheter, followed by the nested guidewire to the target location. In one embodiment, the needle catheter can be advanced over a pre-placed guidewire in an over-the-wire procedure, such as, but not limited to, from an access port in the femoral vein. In other embodiments, the needle catheter, with or without a nested guidewire, can be advanced through the lumen of a pre-placed steerable or non-steerable sheath, supporting / guiding catheter, etc.

[0192] It is understood that after the guidewire has traversed the pericardial space, there may be several additional steps that need to be performed prior to advancing the anchoring system. By way of example, and not limitation, the use of contrast agents, CO2, microcatheters, various guidewires, support / guide catheters, and other devices, drugs and therapeutics may be used for specific purposes. Such devices, drugs and therapeutics may be provided to create physical space in the pericardial space at the target location, to visualize the pericardial space and / or cardiac / pericardial structures at the target location, and to ensure adequate access to the correct diameter guidewire within the pericardium for delivery of the anchoring system.

[0193] According to embodiments, diagnostic tools may be used to provide evidence that the guidewire has traversed the heart wall and entered the pericardial space. By way of example, such diagnostic tools may include, but are not limited to, a guidewire attached to an ECG lead (such as a guidewire having a non-conductive coating except for the proximal and distal tips) and a pressure-sensing guidewire with a sensing element at its distal tip. Data collected from these tools may provide evidence that the guidewire has traversed the heart wall and entered the pericardial space.

[0194] 1A and 1B are side views of an anchor system 30 including an anchor 32 and a tether 34 coupled to the anchor 32. The anchor 32 is operable to have a low profile 33 at a first position 36 and a larger profile 37 at a second position. The anchor 32 is operable to advance from a chamber 6 of the heart 2 through a narrow access channel 12 in a heart wall 41 at the first position 36 into the pericardial space 10 and to expand to a size larger than the narrow access channel 12 at a second position 38 within the pericardial space 10.

[0195] 2A and 2B are cross-sectional views of the heart 2 and its corresponding anatomical features.

[0196] 3-14 are a series of views, and FIG. 15 is a flow diagram of a method of providing an anchor 32 in a heart chamber 6, according to one embodiment. The femoral vein is accessed and a guidewire 40 is advanced therethrough. The guidewire 40 is advanced through the femoral vein into the right atrium 20 (FIG. 3). The guidewire 40 is advanced through the septum 26 into the left atrium 24 (FIG. 4). The guidewire 40 is advanced through the mitral valve 8 and adjacent to the heart wall 41 of the left ventricle 22 (FIGS. 5A and 5B). A needle catheter 42 is advanced over the guidewire 40 to approximately half the thickness 16 of the myocardium 13 (FIG. 6). A guidewire 40 having a stiff distal tip is advanced through the needle catheter 42 through the epicardium 14 into the pericardial space 10 (FIG. 7). A catheter 44 is advanced over the guidewire 40 into the pericardial space 10 (FIG. 8). A gas such as carbon dioxide is used to inflate the pericardium 18 and separate it from the heart wall 41, enlarging the pericardial cavity 10. The anchoring system 30 can be advanced over the guidewire 40 after the catheter 44 is removed and / or advanced through the catheter 44 after the guidewire 40 is removed (FIG. 9). The anchoring system 30 can be operable to be delivered and deployed easily by an anchoring system delivery catheter. The anchors are deployed within the pericardial cavity 10 and positioned against the epicardium 14 (FIG. 10). The anchoring system 30 includes sutures or tethers 34 coupled to the anchors 32, which remain within the heart chamber 6 (FIG. 11).

[0197] It is expected that once the delivery system, i.e., any guidewire 40 and / or catheter 44, is removed from the heart 2, the heart wall 41 will seal around the sutures or tether 34, such that no additional material is required to prevent bleeding from the access channel 12. It is expected that sealing means 48 may optionally be provided to reduce or eliminate the possibility of bleeding. Such sealing means 48 may include, but are not limited to, a surface texture on the tether 34 to induce a healing response between the tether 34 and the heart wall 41, a pledget along the tether 34 that may be used to occlude the access channel 12, an expandable portion or element around the tether 34 and / or anchor 32 operable to close the access channel 12 around the tether 34 and / or anchor 32 (FIG. 12).

[0198] 13, a tether lock 35 is operable to be advanced over the tether 34 against the endocardium 11, engage the tether 34, and securely hold the heart wall 41 captured between the tether lock 35 and the anchor. Such a tether lock 35 can be operable to ensure a forceful engagement of the anchor 32 with the endocardium 11 and prevent movement thereof, for example, to prevent subsequent irritation to the pericardium 18.

[0199] As mentioned above, the sutures or tethers 34 may be used for specific purposes. According to one embodiment, the sutures or tethers 34 are coupled to the mitral valve leaflets 9 to prevent prolapse of the mitral valve leaflets 9 and are shown in FIG.

[0200] According to another embodiment, the suture or tether 34 may be attached to a device such as a prosthetic valve.

[0201] According to another embodiment, the suture or tether 34 may be coupled to a device such as a sensor.

[0202] According to another embodiment, as shown in the flow diagram of FIG. 16, and referring to FIGS. 1-14 for reference, a fixation method includes advancing a guidewire 40 into the heart 2 adjacent to the heart wall 41. A needle catheter 42 is advanced over the guidewire 40 to approximately half the thickness 16 of the heart wall 41. The guidewire 40 is advanced through the needle catheter 42, through the epicardium 14 and into the pericardial space 10. The needle catheter 42 is withdrawn from the guidewire 40. A catheter 44 is advanced over the guidewire 40 into the pericardial space 10. The pericardium 18 is separated from the heart wall 41 to enlarge the pericardial space 10. An anchoring system 30 is advanced over the guidewire 40 or through the catheter 44, with the anchoring portion 39 positioned within the pericardial space 10. The anchors 32 of the anchoring system 30 are deployed within the pericardial space 10 and positioned against the epicardium 14. Guidewire 40 and / or catheter 44 are removed from the patient leaving tether 34 attached to anchor 32 within heart chamber 6.

[0203] According to another embodiment, the fixation method optionally includes advancing a support catheter into the heart, near or up to, adjacent to or against the heart wall. An anchor catheter is advanced alone or through the optional support catheter and positioned near or in forceful engagement with the heart wall. A guidewire is advanced through the anchor catheter, through the endocardium of the heart wall, through the myocardium and through the epicardium (visceral lamina of the serous pericardium) into the pericardial space. An anchor catheter is advanced over the guidewire, through the endocardium of the heart wall, through the myocardium, through the epicardium (visceral lamina of the serous pericardium) into the pericardial space. Optionally, the guidewire is withdrawn from the pericardial space. Optionally, the pericardium is separated from the epicardium to enlarge the pericardial space. An anchor of the anchor system is advanced or exposed through or at or near the distal end of the anchor catheter that is in the pericardial space, and the anchor is positioned in the pericardial space. Anchors of the anchoring system are deployed within the pericardial cavity such that the anchors are positioned against the epicardium, and the guidewire and / or anchor catheter and / or support catheter are removed from the patient, leaving the tether attached to the anchor within the heart chamber.

[0204] According to another embodiment, the anchoring method includes advancing an anchor catheter near or to a wall of the heart within a heart chamber. A guidewire is advanced through the anchor catheter such that a distal tip of the guidewire passes through the endocardium into the myocardium, through the epicardium, and into the pericardial space. The distal tip of the anchor catheter is advanced along or over the guidewire into or adjacent to the pericardial space. An anchor of the anchor system is advanced or exposed through or at a distal end of the anchor catheter that is in the pericardial space, the anchor being positioned within the pericardial space. The anchor of the anchor system is deployed within the pericardial space, the anchor being positioned against the epicardium. The guidewire and / or anchor catheter are removed from the patient, leaving a tether over the guidewire in the pericardial space coupled to the anchor in the heart chamber of the anchor system.

[0205] According to one embodiment, anchoring system 100 includes anchor 102. Figure 18 is a plan view of anchoring system 100 in a pre-deployed configuration, with wire 110 and skirt 120 in a straight configuration. Figure 19 is a plan view of anchoring system 100 in a deployed configuration, with wire 110 and skirt 120 in a ring configuration. Figure 20 is a perspective cross-sectional view of anchoring system 100 deployed within pericardial space 10, with anchor 102 positioned against epicardium 14, with tether 130 passing through endocardium 11, and further including optional tether lock 140 on the opposite side of endocardium 11.

[0206] The anchor 102 includes a wire 110 having a wire first end 112 and a wire second end 114. The wire 110 has a shape memory property that is shape-set into a ring configuration with the wire first end 112 facing the wire second end 114. A skirt 120 is coupled to the wire 110 along an edge that defines a length. A plurality of apertures 126 are along an edge of the skirt 120 opposite the wire 110. A tether 130 is woven alternately through the plurality of apertures 126, with the tether 130 defining a tether first end 132 and a tether second end 134. The first end 132 of the tether and the second end 134 of the tether are operable to be tensioned to cause the skirt 120 to assume a disk-like shape when the wire 110 is in a ring configuration in the deployed configuration, and the first end 132 of the tether and the second end 134 of the tether are operable to be tensioned to stretch the wire 110 into a straight configuration in the pre-deployed configuration.

[0207] In another embodiment, the anchor system 100 is configured such that the first end of the wire 112 and the second end of the wire 114 are operable to be fixedly coupled to one another when in the ring configuration.

[0208] In another embodiment, the anchor system 100 is configured such that when in the ring configuration, the first end 112 of the wire and the second end 114 of the wire are operable to engage to prevent the first end 112 of the wire and the second end 114 of the wire from overlapping beyond a complete loop of the wire 110.

[0209] Another embodiment of the anchor system 100 is configured such that the skirt 120 has tissue ingrowth characteristics on one side and tissue anti-adhesion characteristics on the other side.

[0210] In another embodiment, the anchor system 100 further includes a tether lock 140 slidably coupled to the tether 130 that is operable to slide along the tether 130 and lock into place to capture the heart wall between the tether lock 140 and the anchor 102.

[0211] A method of fixation according to one embodiment includes providing an anchoring system as described above, advancing a guidewire into the femoral vein, advancing the guidewire through the femoral vein and into the right atrium, advancing the guidewire through the septum and into the left atrium, advancing the guidewire adjacent to the heart wall through the mitral valve to the heart wall of the left ventricle, advancing a needle catheter over the guidewire through the endocardium of the heart wall and into the myocardium, advancing the guidewire through the needle catheter, through the myocardium, through the epicardium and into the pericardial space, withdrawing the needle catheter from the guidewire, advancing a catheter over the guidewire into the pericardial space, inflating the pericardium to enlarge the pericardial space. the pericardium from the heart wall by tensioning the pericardium; advancing the anchoring system over the guidewire or through the catheter, where an anchor of the anchoring system is positioned within the pericardial cavity; deploying an anchor of the anchoring system within the pericardial cavity to position the anchor against the epicardium, where the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and where the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether; and removing the guidewire and / or catheter from the patient, leaving the tether coupled to the anchor within the heart chamber.

[0212] A method of fixation according to one embodiment includes providing an anchoring system as described above, advancing a guidewire into the needle catheter such that the distal tip of the guidewire is adjacent to the distal tip of the needle catheter, advancing the distal tip of the needle catheter from the heart chamber through the endocardium of the heart wall into the myocardium, advancing the distal tip of the guidewire through the myocardium and epicardium into the pericardial cavity, advancing an anchor of the anchoring system over the guidewire into the pericardial cavity, and deploying the anchor in the pericardial cavity, wherein the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and wherein the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether.

[0213] A method of fixation according to one embodiment includes providing an anchoring system as described above; advancing a support catheter into the heart up to and adjacent to or against the heart wall; advancing the anchor catheter alone or through the support catheter and forcing engagement and placement against the heart wall; advancing a guidewire along or through the anchor catheter, through the endocardium of the heart wall, through the myocardium, through the epicardium (the visceral lamina of the serous pericardium) and into the pericardial space; advancing the anchor catheter along or over the guidewire, through the endocardium of the heart wall, through the myocardium, through the epicardium (the visceral lamina of the serous pericardium) and into the pericardial space; The method includes advancing or exposing an anchor of an anchoring system through or at a distal end of the anchor catheter within the pericardial cavity, where the anchor is positioned within the pericardial cavity; deploying an anchor of the anchoring system within the pericardial cavity and positioning the anchor against the epicardium, where the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and where the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether; and removing the guidewire and anchor catheter from the patient, leaving the tether coupled to the anchor within the heart chamber.

[0214] A method of fixation according to one embodiment includes providing an anchoring system as described above; advancing an anchoring catheter against the heart wall within a heart chamber to a wall of the heart; advancing a guidewire through the anchoring catheter such that a distal tip of the guidewire is advanced through the endocardium into the myocardium and through the epicardium into the pericardial space; advancing a distal tip of the anchoring catheter along or over the guidewire into or adjacent to the pericardial space; advancing or exposing an anchor of the anchoring system through or at a distal end of the anchoring catheter within the pericardial space; and the anchor is positioned within the pericardial space; deploying an anchor of the anchoring system within the pericardial space and positioning the anchor against the epicardium, where the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether; and removing the guidewire and the anchor catheter from the patient, leaving the tether coupled to the anchor over the guidewire and in the pericardial space within the heart space of the anchoring system.

[0215] FIG. 21 is a side view of an example of a ventricular or pericardial anchor system 200 in an unfolded configuration prior to being loaded onto a delivery system. The pericardial anchor system 200 can be configured to be loaded onto a delivery system and delivered through a catheter. The pericardial anchor system 200 can include an epicardial anchor 220 and a transmyocardial pledget 240, each in a straight or elongated configuration. When loaded into a catheter and delivered, the pericardial anchor system 200 can be in an elongated configuration and exhibit a low profile suitable for advancement through a lumen of the catheter, as shown in FIG. 29. FIG. 22 is an example of a pericardial anchor system 200 with the epicardial anchor 220 in a deployed configuration and the transmyocardial pledget 240 in a pre-deployed configuration. As shown, the epicardial anchor 220 can be in a deployed configuration. The epicardial anchor 220 in the deployed configuration can be compressed, coiled, packed, bunched, curled, curved, etc. 23 is an example of pericardial anchor system 200 in a deployed configuration. As shown, epicardial anchor 220 can be in a coiled configuration and transmyocardial pledget 240 can be in a folded configuration. FIG. 23 further illustrates leaflet anchors and leaflet anchor sutures coupled to pericardial anchor system 200.

[0216] According to one embodiment, the pericardial anchor system 200 includes an epicardial anchor 220, a transmyocardial pledget 240, an anchor socket 260, and a suture lock 270. The epicardial anchor 220 can be an anchor configured such that at least a portion of the anchor is disposed within the pericardial space such that the anchor can resist being pulled through a puncture in the heart wall. At least a portion of the epicardial anchor 220 can be embedded in or in contact with cardiac tissue, such as the epicardium of the heart wall. The epicardial anchor 220 can be such that the epicardial anchor 220 can achieve a disk, ring, or annular configuration in the deployed configuration. The disk, ring, or annular configuration can be planar or non-planar (such as a helical or offset shape). The epicardial anchor 220 can also assume a variety of other shapes in the deployed configuration, such as a curved shape, a compressed shape, a bundle, a mass, or a knot. As described further below, the epicardial anchor 220 can include a wire frame or can be wire-free.

[0217] The epicardial anchor 220 can include a wire or wire frame 222 coupled to a skirt 230. FIG. 24 is a plan view of the wire frame 222 in an unconstrained curved configuration, according to one embodiment. The wire or wire frame 222 can be made of Nitinol, such as Nitinol filled with platinum. The skirt 230 or film as shown in FIG. 21 can be any suitable biocompatible material, such as, but not limited to, fluoropolymer films, such as expanded polytetrafluoroethylene (ePTFE) and expanded polyethylene (ePE). The skirt 230 can have properties operable to promote tissue ingrowth. The wire frame 222 can have a first end of the wire with a distal eyelet 224 and a second end of the wire with a proximal eyelet 226. The distal eyelet 224 and the proximal eyelet 226 can be termini of the wire frame 222. The wire frame 222 can have a proximal leg or T-bar proximal leg 228 at a proximal portion of the wire frame 222 in a straight configuration. The proximal leg 228 can be located distal to the proximal eyelet 226 of the wire frame 222 in a straight configuration. The proximal leg 228 can be a straight portion of the wire frame 222 that remains straight in both the straight and curved configurations, and is in the shape of a ring in this embodiment.

[0218] The proximal legs 228 may be reinforced, such as to resist tension or support forces, relative to the remainder of the wire frame 222. According to one embodiment, the proximal legs 228 may include two portions of the same wire that are doubled up, such that the two portions are parallel to one another and may contact one another and may be joined. In some embodiments, the proximal legs 228 may have stiffer material properties than the remainder of the wire. This may advantageously allow the proximal legs 228 to resist bending and remain straight during deployment of the epicardial anchor 220, such as while abutting the distal end of a delivery catheter, while the remainder of the wire frame 222 may be deployed to form a curved configuration. The proximal legs 228 are configured to retain the epicardial anchor 220 within the pericardial space and to keep the epicardial anchor 220 straight and seated against the delivery catheter distal end 502 and the epicardial puncture to prevent the proximal legs 228 from passing through the epicardium once they enter the pericardial space. The proximal legs 228 are operable to prevent the epicardial anchor 220 from being pulled proximally through the epicardial puncture.

[0219] According to one embodiment, the proximal legs 228 are configured to maintain a straight configuration to present a forceful engagement with a delivery catheter in combination with the curved bias of the remainder of the wire frame 222 to aid in deployment of the epicardial anchor 220. According to another embodiment, the proximal legs 228 are configured to maintain a straight configuration to present a forceful engagement with a delivery catheter in combination with the curved bias of the remainder of the wire frame 222 to assist in deployment of the epicardial anchor 220. According to another embodiment, the proximal legs 228 are configured to maintain a straight configuration to present a profile upon deployment that is operable to prevent the anchor from passing through the epicardial puncture.

[0220] The skirt 230 can be coupled to the wire frame 222 along an edge that defines the length. The wire frame 222 can be disposed at one end or edge of the skirt 230. In one embodiment, the tether or pericardial anchor suture 280 is coupled to an opposite edge of the skirt 230. According to another embodiment, a plurality of anchor apertures 232 are disposed along an edge of the skirt 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is alternately woven through the plurality of anchor apertures 232 and slidably received therethrough. A first end of the pericardial anchor suture 280 is configured to be fixedly coupled to a first end of the skirt 230 at the suture attachment portion 234. The suture attachment portion 234 can be, according to one embodiment, a reinforced portion of the skirt 230 that is reinforced with additional or secondary material added to facilitate and strengthen the coupling. In another embodiment, the reinforcement portions can have different material properties, such as, but not limited to, pressure and / or heat densification, such as with a porous material. The suture attachments 234 can be at or at a distal end of the skirt 230. This can advantageously improve deployment of the epicardial anchor 220 and retention of tension in the pericardial anchor sutures 280. According to one embodiment, the suture attachments 234 provide a predetermined amount of force distribution along the skirt 230 when the distal end or portion of the skirt 230 cooperatively engages with the anchor apertures 232 of the skirt 230, as compared to a more concentrated load at attachment points located more proximally on the skirt 230.

[0221] The entire wire frame 222 may be coupled to a skirt 230. In one embodiment, the skirt 230 may cover the entire wire frame 222, for example by being present in a fold or hem of the film or embedded within a layer of the film, to improve stability of the epicardial anchor 220 in the event of breakage or damage to the wires 22. The skirt 230 covering the wire frame 222 may also prevent the pericardial anchor sutures 280 from being misrouted or entangled in the wire frame 222, particularly during transition of the epicardial anchor 220 from a pre-deployed configuration (e.g., an elongated configuration) to a deployed configuration (e.g., a curved configuration).

[0222] In other embodiments, instead of weaving pericardial anchor sutures 280 through multiple anchor apertures 232, pericardial anchor sutures 280 can be integrated into skirt 230 itself or incorporated into skirt 230 in other ways, such as fixedly attached or slidingly received within a portion of skirt 230. In some examples, skirt 230 can include a tunnel or channel that slidingly receives pericardial anchor sutures 280.

[0223] In other embodiments, a biasing element can be integrated or incorporated into skirt 230 in place of wire frame 222. The biasing element is operable to bias skirt 230 into a curved shape. According to one embodiment, the biasing element can be a densified, embossed or treated portion of skirt 230 operable to bias epicardial anchor 220 to change from a pre-deployed configuration to a deployed configuration, for example, from an elongated shape to a curved shape.

[0224] The epicardial anchor 220 can be maintained in a straight configuration against the biasing force of the wire frame 222 in the pre-deployed configuration by applying tension to the suture distal ends 315 of the pericardial anchor sutures 280 and / or the suture proximal ends 317 of the pericardial anchor sutures 280 that extend through the skirt 230, as shown in FIG. 21. The pericardial anchor sutures 280 can be operable to be tensioned to tighten the skirt 230 into a curved, disk or annular shape when the wire frame 222 is in the deployed configuration. The pericardial anchor sutures 280 can be operable to tighten the skirt 230 such that the skirt 230 extends across the curved portion of the wire frame 222 and completely covers the central portion defined by the wire frame 222.

[0225] Regardless of whether the skirt 240 has a biasing member such as the wire frame 222, the deployed configuration may achieve a configuration such as a coil, mass, bundle, ring, annulus, knot, among others. The deployed configuration may be operable to provide one or more functions, such as, but not limited to, preventing penetration of the puncture through the heart wall, and / or distributing loads caused by tension on the suture over a larger area of ​​the vessel wall, and / or providing a suitable surface for tissue ingrowth and / or overgrowth in a healing response.

[0226] In some instances, the suture proximal end 317 of the pericardial anchor suture 280 is tensioned, for example proximally, when the epicardial anchor 220 is in the deployed configuration to tighten the skirt 230 into the deployed configuration (e.g., compressed, coiled, curved, curled, ringed, annular, knotted, bundled, or clumped). The biasing force of the biasing member is biased to pull the skirt into the curved shape. The tension on the pericardial anchor suture 280 can assist in the curvature of the biasing member and / or ensure a fully deployed configuration (e.g., curved or ring configuration). The epicardial anchor 220 can transition from a pre-deployed configuration (e.g., elongated configuration) as shown in FIG. 21 to a deployed configuration (e.g., coiled configuration) as shown in FIGS. 22 and 23. This transition can be facilitated at least in part by tension applied to the pericardial anchor suture 280, or the biasing force of a biasing element such as the wire frame 222, or both.

[0227] According to one embodiment, the wire frame 222 has shape memory properties that allow it to be shaped into a curved, ring-like, or annular configuration, as shown in FIG. 24. As shown in FIG. 24, when the epicardial anchor 220 is in a deployed state, the T-bar or proximal leg 228 remains straight and the remaining portion of the wire frame 222 is biased to conform to a curved configuration in the deployed, i.e., unconstrained, configuration. The T-bar proximal leg 228 may be positioned at the center of the epicardial anchor 220 in the deployed configuration of the curved configuration. The T-bar proximal leg 228 may be positioned to overlap the center of the curve defined by the epicardial anchor 220 such that it extends across the diameter of the epicardial anchor 220 when in the ring configuration, according to one embodiment. The wire frame 222 may be configured such that a portion of the wire frame 222 overlaps another portion of the wire frame 222. For example, a distal portion of the wire frame 222, including the distal eyelet, overlaps another portion of the wire frame 222, such as around the epicardial anchor 220 in a deployed state. The distal eyelet 224 can be positioned to overlap the circumference of the epicardial anchor 220 in the deployed configuration. The proximal eyelet 226 can be positioned at or near the end of the T-bar proximal leg 228 or at the double back portion 229 and overlap or be adjacent to the circumference of the epicardial anchor 220 in the deployed configuration. The distal eyelet 224 and the proximal eyelet 226 can provide an atraumatic end of the wire frame 222 that prevents damage to the delivery system and / or adjacent tissue during deployment of the epicardial anchor 220 or after the epicardial anchor 220 is implanted in the pericardial space. In other examples, the epicardial anchor 220 can have other types of atraumatic ends, such as rounded ends or blunt ends, instead of eyelets. The atraumatic ends can advantageously prevent damage to tissue during the implant procedure or to other portions of the anchor system, such as the skirt 230.

[0228] In some configurations, the wire frame 222 can be biased to form a helix when in a curved configuration in the deployed configuration. This bias toward a helix can advantageously prevent the wire frame 222 from entangling itself, other components of the anchor system, or the implant treatment area. The helix configuration can help allow the epicardial anchor 220 to transform into a coiled configuration. In some configurations, the wire frame 222 has a bias that conforms to the epicardial anchor 220 to define a substantially planar disk when in the deployed configuration.

[0229] In other embodiments, instead of a coiled configuration as shown in FIGS. 22 and 23, the epicardial anchor 220 can transition from a pre-deployed configuration (e.g., an elongated configuration) suitable for a pre-deployed configuration, such as within a catheter, to a deployed configuration (e.g., a ring-like, coiled, curved, compressed, bundled, or massed configuration) in various ways. For example, the epicardial anchor 220 can begin to curve or coil, or form a deployed shape, such as a disk-like shape, beginning or starting at a free end of the epicardial anchor 220. The free end can be the distal end of the epicardial anchor 220, which can be the distal terminus of both the epicardial anchor 220 and the pericardial anchor system 200. The coiling that may occur can be partial to form a partial disk shape, complete to form a complete disk shape, or overlap to form a complete disk shape. The disk-like shape can have a low profile so as not to significantly abut or otherwise interfere with the visceral pericardium. The size of the disk-like shape may be operatively configured to prevent the epicardial anchor 220 from penetrating the heart wall through the myocardial puncture or channel from the delivery subsystem 400 or the pericardial anchor suture 280. The size of the disk-like shape may be operatively configured to atraumatically distribute forces on the abutting epicardial anchor 220 and surrounding tissue caused by tension on the remainder of the pericardial anchor system 200. According to one embodiment, the disk shape is ideal because it avoids stress concentrations, such as those associated with sharp bends in the wire frame 222, which may cause failure during fatigue. According to other embodiments, the shape of the anchor may define other shapes, such as, but not limited to, a square, a cross, and a diamond. The wire frame 222 of the epicardial anchor 220 is operative to straighten out and return to a low-profile, high-surface-area shape, which is advantageous for delivery and deployment of the epicardial anchor 220.The epicardial anchor 220 defining a surface area within its disc-like shape may also promote tissue ingrowth and / or distribute the load on the pericardial anchor system 200 over a larger area of ​​the heart surface.

[0230] In some embodiments, the epicardial anchor 220 can be bundled or clumped to achieve the deployed configuration. For example, the epicardial anchor 220 in an elongated configuration can be folded, compressed, bundled, rolled, or clumped to form the deployed configuration.

[0231] As mentioned above, the pericardial anchor system 200 may also include a pericardial anchor suture 280. The pericardial anchor suture 280 may extend through each of the epicardial anchor 220 and the transmyocardial pledget 240. The pericardial anchor suture 280 may be coupled to the skirt 230 of the epicardial anchor 220, for example, but not limited to, by weaving through or integrating with the skirt 230. As shown in FIG. 21 , the pericardial anchor suture 280 may be woven through multiple anchor apertures 232 through the skirt 230. The pericardial anchor suture 280 may extend from the skirt 230 of the epicardial anchor 220 and then be woven through the transmyocardial pledget 240. The pledget 240 may also include multiple pledget apertures 262, and the pericardial anchor suture 280 may be woven through the multiple pledget apertures 262. The pericardial anchor suture 280 may be made from any suitable biocompatible material, such as, but not limited to, a fluoropolymer fiber.

[0232] The pericardial anchor system 200 may include the pledgets disclosed in International Application No. PCT / US2020 / 032054 or International Application No. PCT / US2020 / 032168, which are incorporated herein by reference in their entirety, and various embodiments of the pledgets disclosed therein. The transmyocardial pledget 240 may include a film. The film may be a fluoropolymer having tissue ingrowth properties. The film of the transmyocardial pledget 240 may have a tubular structure. The transmyocardial pledget 240 may include a plurality of pledget apertures 262 disposed along the length of the transmyocardial pledget 240. The pericardial anchor sutures 280 may be woven through or integrated into the film of the transmyocardial pledget 240. As shown in FIG. 21 and FIG. 22, the pericardial anchor sutures 280 may be woven through a plurality of pledget apertures 262 through the film of the transmyocardial pledget 240. The pericardial anchor sutures 280 allow the transmyocardial pledget 240 to be transformed from a straight configuration, as shown in Figure 21, to a curved configuration, as shown in Figure 23. For example, tension or contraction of the pericardial anchor sutures 280 can cause the material of the transmyocardial pledget 240 to compress or fold in an accordion-like manner. The transmyocardial pledget 240 can incorporate pleats to facilitate folding during deployment of the transmyocardial pledget 240.

[0233] As shown in FIG. 21 , the epicardial anchor 220 can be positioned at a distal end of the pericardial anchor system 200 and the transmyocardial pledget 240 can be positioned proximally from the epicardial anchor 220. The transmyocardial pledget 240 can extend from a proximal leg 228 of the epicardial anchor 220. The transmyocardial pledget 240 can be laminated or otherwise coupled directly to the proximal leg 228 of the wire frame 222 of the epicardial anchor 220. This can advantageously allow the proximal leg 228 to be positioned across the epicardial puncture during placement of the transmyocardial pledget 240 through the epicardium and myocardial puncture. The transmyocardial pledget 240 is operable to seal the puncture in the heart wall. In some configurations, as shown in FIG. 21 , the epicardial anchor 220 and the transmyocardial pledget 240 can extend at an angle to each other in a pre-deployed configuration. In some configurations, the epicardial anchor 220 and the transmyocardial pledget 240 may extend linearly relative to one another.

[0234] The transmyocardial pledget 240 is configured to extend from the epicardial anchor 220 through the epicardium, myocardium, and endocardium punctures, also referred to as the heart wall channel 5, as shown in FIG. 36. The transmyocardial pledget 240 can fill and seal the heart wall channel 5 defined in the epicardium, myocardium, and endocardium by a delivery system that crosses the heart wall to access the pericardial cavity. The transmyocardial pledget 240 is configured to expand into and seal the myocardial puncture. The portion of the transmyocardial pledget 240 that is disposed through the myocardial heart wall channel 5 can extend in a straight configuration, while the material of the transmyocardial pledget 240 that is disposed adjacent the endocardium can collapse or fold and seal across the heart wall channel 5 at the endocardium. This advantageously allows the transmyocardial pledget 240 to accommodate different myocardial thicknesses by collapsing to the endocardium and / or expanding to a diameter sufficient to prevent leakage through the heart wall channel 5.

[0235] The pericardial anchor system 200 may further include an anchor socket 260 capable of holding a suture lock 270. The pericardial anchor system 200 may include a suture lock as disclosed in U.S. Pat. No. 9,877,833. The pericardial anchor system 200 may include a suture lock and socket as disclosed in International Application No. PCT / US2021 / 035423 or U.S. Patent Application No. 16,711,321 (incorporated herein by reference in its entirety) and various embodiments of the suture lock or socket disclosed therein. The pericardial anchor system 200 may include a socket as disclosed in U.S. Patent Application No. 16 / 710,637 (incorporated herein by reference in its entirety) and various embodiments of the suture lock or socket disclosed therein. The suture lock 270 may be used to secure each of the pericardial anchor suture 280 and the leaflet anchor suture 310. Additionally, the suture lock 270 can be used to tension and adjust the length of each of the pericardial anchor sutures 280 and leaflet anchor sutures 310. Once the lengths have been optimized to achieve the proper tension for the mitral valve chordae tendineae repair, the suture lock 270 can be locked to fix the lengths of each of the pericardial anchor sutures 280 and leaflet anchor sutures 310.

[0236] As used herein, the term "socket" includes and may be used interchangeably with any of the terms cover, receptacle, shroud, coupler, restraint, retention member, and the like. According to one embodiment, the anchor socket 260 may have a tubular structure capable of receiving and at least partially covering the suture lock 270. The anchor socket 260 may include a self-expanding frame that may minimize the profile of the anchor socket 260 when in a pre-deployed configuration on a delivery system. The self-expanding frame may be a nitinol stent frame. The self-expanding frame may be tapered to facilitate docking of the suture lock 270 within the anchor socket 260 and to more tightly constrain the anchor socket 260 around the sutures 280, 310. The anchor socket 260 may further include a gold marker band around the periphery of the anchor socket 260, which may provide visual guidance. The self-expanding frame may also be covered with a fluoropolymer film. In some configurations, the inner surface of the stent frame can be covered with a fluoropolymer film. This film can extend proximally from the film of the transmyocardial pledget 240. The anchor socket 260 can have a length that exceeds the length of the suture lock 270 to ensure complete coverage of the suture lock 270 by the anchor socket 260. The anchor socket 260 can be a retaining member to constrain movement of the suture lock relative to the rest of the pericardial anchor system 200 and movement of the suture relative to the suture lock 270. The anchor socket 260 is also referred to as a suture lock guide, socket, or sleeve. The anchor socket 260 can reduce wear on the pericardial anchor sutures 280 and leaflet anchor sutures 310, respectively, and can ensure tension in the sutures. The anchor socket 260 can couple the pericardial anchor system 200 and the suture lock.

[0237] 21-23, the anchor socket 260 and suture lock 270 may extend from or be positioned proximally from the transmyocardial pledget 240. This location of the anchor socket 260 advantageously facilitates folding and collapsing of the transmyocardial pledget 240 between the endocardial surface and the anchor socket 260.

[0238] 22, the transmyocardial pledget 240 may also include a catheter access hole 242 adjacent the anchor socket 260 at a proximal end of the transmyocardial pledget 240. The catheter access hole 242 in the transmyocardial pledget 240 advantageously allows catheter components, such as, but not limited to, the guidewire sheath 420 and / or the anchor sheath 440 of the delivery subsystem 400 to exit and out of the socket lumen 264 of the anchor socket 260, as shown in FIG. 22, and to extend along the transmyocardial pledget 240 and the epicardial anchor 220, as shown in FIG.

[0239] 25A is an example of a ventricular anchor system with a separate socket. The anchor socket 260 can be separate from the remainder of the pericardial anchor system 200. The anchor socket 260 can be disposed proximally from and connected to the transmyocardial pledget 240, but can be separate in that the anchor socket 260 is configured to translate relative to the transmyocardial pledget 240.

[0240] Instead of an epicardial disk anchor, various types of ventricular or epicardial anchors can take various shapes other than a disk or annular shape. The ventricular or epicardial anchors can be drawstring anchors that can be tensioned or retracted with sutures to convert the anchor from a pre-deployed configuration to a deployed configuration. The pre-deployed configuration can be an elongated configuration. The deployed configuration can take various shapes, including disk-like, annular, curved, compressed, bundled, clumped, or knotted shapes, as described above. FIG. 25B is an example of a pericardial anchor system with a T-bar epicardial anchor. The ventricular anchor system in FIG. 25B can be similar to the pericardial anchor system 200 described above. However, instead of the wire frame 222 and skirt 230 of the epicardial anchor 220, the ventricular anchor system shown in FIG. 25B can include a T-bar epicardial anchor that includes a film-covered T-bar 290. The T-bar 290 can function similarly to the T-bar proximal leg 228 of the epicardial anchor 220. The T-bar 290 may be positioned relative to the myocardial puncture in the epicardial space. The film covered T-bar 290 may be integral with or separate from the transmyocardial pledget 240.

[0241] FIG. 26A is an example of a pericardial anchor system with a frameless epicardial anchor. The ventricular anchor system of FIG. 25B can be similar to the pericardial anchor system 200 described above. However, instead of the wire frame 222 and skirt 230 of the epicardial anchor 220, the ventricular anchor system of FIG. 25B can include a wireless skirt 230 or film. The wireless skirt 230 can function similarly to the skirt 230 of the epicardial anchor 220. The pericardial anchor sutures 280 can be integrated into or woven through the wireless skirt 230. The pericardial anchor sutures 280 can be tensioned to tighten the wireless skirt 230 into a disk, ring, or bundled mass configuration in the deployed configuration, as shown in FIG. 26A.

[0242] FIG. 26B is an example of a pericardial anchor system with a T-bar and a frameless epicardial anchor. The ventricular anchor system in FIG. 25B can be similar to the pericardial anchor system 200 described above. However, instead of the wire frame 222 and skirt 230 of the epicardial anchor 220, the pericardial anchor system in FIG. 25B can include a T-bar proximal leg 228 covered by a film or wireless skirt 230. The film / skirt covered T-bar can extend proximally from the wireless skirt 230. The T-bar 290 can function similarly to the T-bar proximal leg 228 of the epicardial anchor 220. The T-bar 290 can be positioned against a puncture of the myocardium in the epicardial space. The film or skirt covered T-bar 290 can be integrated or separate from the transmyocardial pledget 240. The wireless skirt 230 can function similarly to the skirt 230 of the epicardial anchor 220. Pericardial anchor sutures 280 can be integrated with or woven through wireless skirt 230. Tension can be applied to pericardial anchor sutures 280 to tighten wireless skirt 230 into a ring configuration in the deployed configuration as shown in FIG.

[0243] The wireless skirt 230 can function similarly to the skirt 230 of the epicardial anchor 220. The pericardial anchor sutures 280 can be incorporated or woven into the wireless skirt 230. The pericardial anchor sutures 280 can fasten the wireless skirt 230 into a disk-like, ring-like, curved, or bundled mass configuration in the deployed configuration, as shown in FIG.

[0244] 27 is an example of a pericardial anchor system 200 deployed and partially implanted in place within a ventricle of the heart. As shown, an epicardial anchor 220 in a ring configuration is positioned within the pericardial cavity. The epicardial anchor 220 can anchor the pericardial anchor system 200 and function as a mechanical interface for anchoring the pericardial anchor system 200. The epicardial anchor 220 can also function to seal one end of the myocardial puncture. A transmyocardial pledget 240 extends from the epicardial anchor 220, extending partially through the heart wall 41 and partially folded against the endocardial layer of the heart wall 41. A suture lock 270 disposed within the anchor socket 260 can be positioned against the folded portion of the transmyocardial pledget 240. The suture lock 270 surrounded by the anchor socket 260 can drive the anchor socket 260 to the endocardial surface, which can also facilitate sealing of the puncture on the endocardial surface by the folded portion of the transmyocardial pledget 240. The pericardial anchor suture 280 can extend through the epicardial anchor 220, through the transmyocardial pledget 240, and into the suture lock 270. The pericardial anchor suture 280 can also function as a tension member for forming the epicardial anchor 220. The pericardial anchor suture 280 can provide a rail for connecting the suture lock 270. The transmyocardial pledget 240 can protect the heart wall 41 from injury by the pericardial anchor suture 280. The transmyocardial pledget 240 adds bulk to the pericardial anchor suture 280, which by itself can tend to cut or slice the myocardium when tensioned or loaded. The transmyocardial pledget 240 prevents migration of the pericardial anchor suture 280 within the myocardium. The transmyocardial pledget 240 can form a myocardial seal by blocking a channel or puncture through the heart wall 41 and folding over to seal the opposite end of the puncture on the endocardial surface. The suture lock 270 can also capture the leaflet anchor suture 310. The leaflet anchor suture 310 can extend between the suture lock 270 and the leaflet anchor 300 implanted in the leaflet 9 to repair the mitral chordae tendineae.

[0245] 28A is an example of a leaflet anchor implanted in a valve leaflet and leaflet anchor sutures 310 extending between the leaflet anchor 300 and at least the pericardial anchor system 200 implanted in the ventricular wall. As shown, the pericardial anchor system 200 is implanted in the ventricular wall such that the anchor socket 260 is positioned against the endocardial surface of the heart wall 4s. The leaflet anchor 300 can be an anchor configured such that at least a portion of the anchor is positioned in or on the leaflet. At least a portion of the epicardial anchor 220 can be embedded in or in contact with the tissue of the leaflet. The leaflet anchor 300 can be of various shapes such as a pledget, clip, or hook. The leaflet anchor sutures 310 can extend from a suture lock 270 positioned in the anchor socket 260 and extend to the leaflet anchor 300. The leaflet anchor 300 can be an anchor positioned in the mitral valve leaflet 9. Leaflet anchor 300 can be a pledget.

[0246] 28B is a cross-sectional view of a ventricular wall with a ventricular anchor system implanted therein. As shown, an epicardial anchor 220 may be positioned within the pericardial space 10. A transmyocardial pledget 240 may extend from the epicardial anchor 220 through the endocardium, myocardium, and epicardial puncture. The transmyocardial pledget 240 may also be folded against the endocardial surface of the heart wall 41. An anchor socket 260 may be positioned against the endocardium of the heart wall 41.

[0247] FIG. 28C is a diagram of epicardial anchor 220 implanted within the pericardial space.

[0248] Figure 29 is an example of a delivery system or delivery subsystem 400 in a first configuration. Figure 30 is an example of the delivery subsystem 400 of Figure 29 in a second configuration. Figure 31 is an example of a guidewire sheath of the delivery subsystem 400 of Figures 29 and 30.

[0249] The delivery subsystem 400 may be delivered through a delivery catheter. The delivery subsystem 400 may include three catheters or sheaths including a support sheath 460, an anchor sheath 440, and a guidewire sheath 420. The delivery subsystem may further include a guidewire 410 configured to be delivered through the guidewire sheath 420. The sheaths 420, 440, 460 may be configured to fit together or nest within one another. The support sheath 460 may be an outer sheath that receives the anchor sheath 440. The anchor sheath 440 may be an intermediate sheath that is received by the support sheath 460 and receives the guidewire sheath 420. The guidewire sheath 420 may be received by the anchor sheath 440 and receives the guidewire 410. FIG. 29 shows the guidewire sheath 420 withdrawn further distally from the anchor sheath 440 than shown in FIG. 30. Guidewire 410 can be disposed within the inner circumference of guidewire sheath 420, which allows for delivery of guidewire 410 through guidewire sheath 420. Pericardial anchor system 200 can be disposed between the outer circumference of guidewire sheath 420 and the inner circumference of anchor sheath 440, which allows for delivery of pericardial anchor system 200 by retracting anchor sheath 440.

[0250] FIG. 32 is an example of a guidewire sheath 420 associated with a pericardial anchor system 200. The anchor sheath 440 is retracted. As shown in FIG. 32, the pericardial anchor system 200 can be disposed on an outer surface of the guidewire sheath 420. The guidewire sheath 420 can include a number of sleeves 424 on the outer surface of the guidewire sheath 420 and between the portions of the pericardial anchor system 200 to constrain the portions of the pericardial anchor system 200. For example, the sleeves 424 can be disposed on either side of the anchor socket 260 of the pericardial anchor system 200. The sleeves 424 can help advance or position various portions of the ventricular anchor system. For example, the sleeves 424 can be disposed proximal to the epicardial anchor 220 to allow advancement of the epicardial anchor 220 along with advancement of the guidewire sheath 420. For example, sleeve 424 can be positioned proximally relative to epicardial anchor 220 to allow for placement of T-bar proximal leg 228 of epicardial anchor 220 during the implant procedure. Sleeve 424 can be made from plastic. Guidewire sheath 420 can further include fluoroscopic markers. Anchor sheath 440 can be placed over pericardial anchor system 200 to restrain pericardial anchor system 200 until ready for deployment. Anchor sheath distal end 442 of anchor sheath 440 can be used to engage the T-bar after deployment to provide abutment or leverage against wire frame 222 during tightening of pericardial anchor sutures 280.

[0251] The support sheath 460 can provide control to guide the delivery subsystem 400 to a target location, such as the left ventricle or the ventricular wall of the left ventricle. The support sheath 460 can provide support while the pericardial anchor system is advanced through the ventricular wall, such as advancement of the guidewire 410 or the anchor sheath 440. The support sheath 460 can have at least a trackable distal portion. The distal portion of the anchor sheath 440 is operable to advance through the heart wall 41, including the endocardium, myocardium, and epicardium of the heart wall 41. The anchor sheath 440 can have at least a proximal portion that is more rigid relative to the trackable distal portion, providing more control during delivery. The anchor sheath 440 can include a radiopaque marker at the distal or tip of the anchor sheath 440.

[0252] The guidewire sheath 420 can be a thin-walled catheter. The guidewire sheath 420 can include a dilator tip 422 at the distal end of the guidewire sheath 420. The dilator tip 422 can be smooth and tapered to minimize trauma as it traverses the heart wall 41. The proximal end of the dilator tip 422 is tapered to allow for smooth withdrawal of the dilator tip 422 and to minimize trauma as it is withdrawn through the heart wall 41.

[0253] 33-41 are a series of views of a method of providing a pericardial anchor system 200, according to one embodiment.

[0254] 33 is a cross-sectional view of a heart with a delivery catheter 500 according to one embodiment of a method of providing pericardial anchoring system 200. Delivery catheter 500 can be positioned in the left atrium. Delivery catheter 500 can be delivered via a transfemoral, transseptal approach.

[0255] FIG 34 is a cross-sectional view of a heart with a delivery subsystem 400 for the pericardial anchor system 200 according to one embodiment of a method of providing the pericardial anchor system 200. The delivery subsystem 400 for the pericardial anchor system 200 may be delivered through a delivery catheter 500. The delivery subsystem 400 may then be advanced to a target location, such as through the mitral valve to a target location in the heart wall 41 between the papillary muscle bases of the left ventricle. FIG 35 is a cross-sectional view of the heart wall 41 with a support sheath 460 of the delivery subsystem 400 according to one embodiment of a method of providing the pericardial anchor system 200. The support sheath 460 of the delivery subsystem 400 for the pericardial anchor system 200 may be advanced to the heart wall 41 of the left ventricle, as shown in FIG 34 and FIG 35.

[0256] 36 is a cross-sectional view of the heart wall 41 with a guidewire 410 of a delivery subsystem 400 according to one embodiment of a method of providing a pericardial anchor system 200. The guidewire 410 of the delivery subsystem 400 may be advanced distally from a distal end of a support sheath 460. The guidewire 410 may puncture the heart wall 41 and be advanced through the heart wall 41, including the endocardium, myocardium and epicardium, and guided into the pericardial space 10. The guidewire 410 is positioned within the pericardial space 10 such that an anchor may subsequently be delivered over the guidewire 410 into the pericardial space 10. Selection of the stiffness of the guidewire may be optimized, without limitation, both at the distal tip and along its entire length such that it is at least stiff enough for the distal tip to traverse the heart wall 41 and enter the pericardial space 10, but soft enough to flex within the pericardial space 10 and not puncture the pericardium (serous pericardium and parietal plate of fibrous pericardium). The guidewire 410 is operable to rotate and track within the pericardial space 10. Advancement of the distal end of the guidewire 410 within the pericardial space 10 adjacent the heart wall 41 may provide evidence to the clinician that the distal end of the guideline 10 is within the pericardial space 10. Deflection of the guidewire 410 into the pericardial space 10 may advantageously provide tactile feedback due to the guidewire 410 popping across the epicardium and the subsequent free movement of the guidewire 410 within the pericardial space 10.

[0257] 37A is a cross-sectional view of heart wall 41 with anchor sheath 440, according to one embodiment of a method of providing pericardial anchor system 200. Anchor sheath 440 and guidewire sheath 420 with dilator tip 422 can be advanced together distally from support sheath 460 over guidewire 410, through heart wall 41, including the endocardium, myocardium and epicardium, and into pericardial space 10.

[0258] FIG. 37B is a cross-sectional view of a heart with an anchor sheath 440 according to one embodiment of a method of providing a pericardial anchor system 200. The anchor sheath 440 and the guidewire sheath 420 with the dilator tip 422 can be advanced deep into the pericardial space 10. The anchor sheath 440 and the guidewire sheath 420 can be advanced a predetermined distance to desheath the epicardial anchor in a pre-deployed configuration. For example, as shown in FIG. 37B, the anchor sheath 440 and the guidewire sheath 420 can be advanced at least 10 cm into the pericardial space 10, and in some embodiments, at least 15 cm or 16 cm into the pericardial space 10. As shown, the anchor sheath 440 and the guidewire sheath 420 can be deployed tangentially along the heart wall 41 within the pericardial space. In some instances, the anchor sheath 440 and the guidewire sheath 420 can be extended adjacent to the right atrium. The anchor sheath 440 and the guidewire sheath 420 may be advanced in a medial / lateral or inferior / superior direction, or a combination thereof. This is advantageous because the anchor sheath 440 and the guidewire sheath 420 can move tangentially within the pericardial space 10 without the need to extensively or additionally dilate or extend the pericardial space itself. The anchor sheath 440 and the guidewire sheath 420 can be extended an appropriate length to desheath the epicardial anchor 220 in the elongated configuration.

[0259] 38 is a cross-sectional view of heart wall 41 with anchor sheath 440 partially retracted to deliver epicardial anchor 220 of pericardial anchor system 200, according to one embodiment of a method of providing pericardial anchor system 200. With guidewire sheath 420 in place, support sheath 460 and anchor sheath 440 can be retracted together to expose pericardial anchor system 200 located between anchor sheath 440 and guidewire sheath 420. In some instances, anchor sheath 440 can be retracted until a marker band on anchor sheath 440 reaches a marker band on guidewire sheath 420, causing pericardial anchor system 200 to be desheathed. Anchor distal end 225 of epicardial anchor 220 is first desheathed and, once no longer constrained by anchor sheath 420, can begin to transition (e.g., curve or coil) due to the biasing or shape memory properties of the biasing element. When epicardial anchor 220 is fully exposed and desheathed, proximal leg 228 of epicardial anchor 220 can abut against the tip of anchor sheath 440 and heart wall 41 as anchor sheath 440 is retracted.

[0260] 38 is a cross-sectional view of the heart wall 41 with the anchor sheath 440 partially retracted to deliver the pericardial anchor system 200 according to one embodiment of a method of providing the pericardial anchor system 200. The position of the anchor sheath 440 can then be maintained and the guidewire sheath 420 can be retracted to form a T-bar between the proximal leg 228 of the epicardial anchor 220 and the tip of the anchor sheath 440. All sheaths, the support sheath 460, the anchor sheath 440 and the guidewire sheath 420, can then be retracted together until the proximal leg 228 is positioned against the epicardial puncture. The epicardial anchor 220 can be positioned between the epicardium and the guidewire sheath 420. This can prevent the epicardial anchor 220 from retracting into the epicardial puncture and can maintain the position of the epicardial anchor 220 within the pericardial space.

[0261] 39 is a cross-sectional view of the heart wall 41 with the anchor sheath 440 partially retracted to deliver the pericardial anchor system 200, according to one embodiment of a method of providing the pericardial anchor system 200. The guidewire sheath 420 can then be maintained in position and the anchor sheath 440 and support sheath 460 can be retracted together to deploy the transmyocardial pledget 240 and anchor socket 260. The transmyocardial pledget 240 can be placed through the myocardium and into the puncture, as can the anchor sheath 440 and support sheath 460. Once the myocardial puncture is filled, the remaining or excess length of the transmyocardial pledget 240 can extend proximally from the endocardium, as shown in FIG. 39. The anchor socket 260 can extend proximally from the transmyocardial pledget 240.

[0262] 40 is a cross-sectional view of the heart wall with guidewire sheath 420 retracted to deliver pericardial anchor system 200 according to one embodiment of a method of providing pericardial anchor system 200. Guidewire sheath 420 and guidewire 410 may be retracted to deploy pericardial anchor system 200. Guidewire sheath 420, anchor sheath 440, and support sheath 460 may then all be withdrawn to fully expose pericardial anchor system 200. Once pericardial anchor system 200 is fully deployed, tension may be applied to pericardial anchor suture 280 to fully coil or curl epicardial anchor 220. Tension may also be applied to pericardial anchor suture 280 to tighten skirt 230 around wire frame 222 in a ring configuration, as shown in FIG. 41. This fully transforms epicardial anchor 220 from the straight configuration of the pre-deployment state to the coiled configuration of the deployed state.

[0263] The epicardial anchor 220 may be constrained in a pre-deployed configuration during delivery, such as by an anchor sheath 440 as shown in FIG. 37A. The epicardial anchor 220 may be delivered and positioned in the pericardial space 10 through a delivery subsystem 400 as shown in FIGS. 38-39. Once the epicardial anchor 220 is positioned in the pericardial space 10 and released from the anchor sheath 440, the shape memory of the wire frame 222 may allow the epicardial anchor 220 to begin to transform from the elongated shape of the pre-deployed state to at least a partially coiled configuration. The distal end of the epicardial anchor 220 with the distal eyelet 224 in a straight configuration is released from the anchor sheath 440 first. The anchor distal end 225 as shown in FIG. 21 is the free end of the epicardial anchor 220 that may begin to transition (e.g., curl or coil) once it exits the anchor sheath 440 and is no longer constrained by the anchor sheath 440. However, the limited space of the pericardial cavity 10 may constrain the epicardial anchor 220 and prevent it from reaching a fully curved or coiled configuration in the deployed configuration. The remaining portion of the epicardial anchor 220 passing through the proximal leg 228 is then released from the anchor sheath 440 as the anchor sheath 440 is further retracted from the guidewire sheath 420. The remaining portion of the pericardial anchor system 200 may be released from the anchor sheath 440, including the transmyocardial pledget 240 and the anchor socket 260. Tension may then be applied to the pericardial anchor sutures 280 of the pericardial anchor system 200 to fully coil the epicardial anchor 220 and tighten the skirt 230 of the epicardial anchor 220, converting the epicardial anchor 220 to the fully coiled configuration in the deployed state. The epicardial anchor 220 may be positioned relative to the epicardial puncture.

[0264] 41 is a cross-sectional view of a heart wall 41 implanted with a pericardial anchor system 200, according to one embodiment of a method of providing the pericardial anchor system 200. As shown, a fully coiled epicardial anchor 220 may be positioned against the epicardial puncture within the pericardial space 10 to seal the epicardial puncture. At least a portion of the transmyocardial pledget 240 may fill the endocardium, myocardium, and endocardial puncture. The remaining portion of the transmyocardial pledget 240 may extend proximally from the epicardial puncture. An anchor socket 260 may extend proximally from the transmyocardial pledget 240. As described further below, the remaining portion of the transmyocardial pledget 240 may be positioned against the endocardial puncture and collapsed or folded to seal the endocardial puncture.

[0265] According to one embodiment, pericardial anchor system 200 may be used to control the movement of the mitral valve leaflets by coupling pericardial anchor sutures 280 to one or more leaflet anchor sutures 310, also referred to as tethers, that are coupled to the mitral valve leaflets 9. After the epicardial anchor 220 is delivered to the target location, leaflet anchor system 510 may be used to couple pericardial anchor sutures 280 to the mitral valve leaflets 9, as shown in FIG. 52. Leaflet anchor system 510 includes leaflet anchor 300 and leaflet anchor suture 310 operable to pass through and couple to mitral valve leaflets 9.

[0266] 42-46 are a series of views of an embodiment of a leaflet anchoring system 510 and an embodiment of a method of providing leaflet anchoring using the pericardial anchoring system 200 in combination with the leaflet anchoring system 510. In some instances, this method of providing leaflet anchoring can be provided multiple times to provide multiple leaflet anchoring. In some instances, the leaflet anchoring system 510 can be used to pass the leaflet anchor sutures 310 through the mitral valve leaflets 9 multiple times, according to one embodiment.

[0267] 42 is a cross-sectional view of heart 4 illustrating a delivery subsystem 520 operable with leaflet anchoring system 510, according to one embodiment of a method of providing leaflet anchoring using pericardial anchoring system 200. The delivery subsystem 520 for leaflet anchoring system 510 may be delivered via a delivery catheter 500. The delivery subsystem 520 may be positioned adjacent a first side of the leaflet 9, such as, but not limited to, the atrial side of the leaflet 9.

[0268] 43 is a cross-sectional view of heart 4 illustrating a needle 522 of leaflet anchoring system 510 according to one embodiment. Delivery subsystem 520 can deliver needle 522, which can be positioned adjacent a first side of leaflet 9. Needle 522 can puncture through leaflet 9 and extend from the first side of leaflet 9 to a second side of the leaflet, for example, but not limited to, from the atrial side to the ventricular side of leaflet 9.

[0269] 44 is a cross-sectional view of the heart 4 showing a leaflet anchor 524 according to one embodiment. The leaflet anchor 524 may be delivered through the needle 522 such that the leaflet anchor 524 extends from the distal end of the needle 522. In one embodiment, the leaflet anchor system 312 includes a leaflet anchor suture 310 and a leaflet anchor 524, such as, but not limited to, the leaflet anchor 300 as shown in FIG. 23 and FIG. 46. According to one embodiment, as shown in FIG. 44, the leaflet anchor 524 is coupled to the leaflet anchor suture 310, such as, but not limited to, by being integral with or woven through the leaflet anchor 300 and extending from the leaflet anchor 300 to the leaflet anchor system 312. Embodiments of the leaflet anchor 524 also include, but are not limited to, knots, stitches, staples, adhesives, and suture clips.

[0270] 45 is a cross-sectional view of a heart 4 with a leaflet anchor 524 according to one embodiment. Tension can be applied to the leaflet anchor sutures 310 to collapse or fold the leaflet anchor 524, in this embodiment, to collapse or fold the leaflet anchor 300 against the second side of the leaflet 9. The leaflet anchor 300 is operable to clamp into a compressed configuration when tension is applied to the leaflet anchor sutures 310 to prevent the leaflet anchor 300 from being pulled through the puncture in the leaflet 9 through which it extends.

[0271] 46 is a cross-sectional view of the heart 4 with the delivery subsystem 520 for the leaflet anchoring system 312 withdrawn. The delivery subsystem 520 can be withdrawn through the delivery catheter 500.

[0272] Once leaflet anchoring system 312 is deployed at a target location on leaflet 9, suture lock 270 is provided to lock leaflet anchor sutures 310 from pericardial anchoring system 200 and leaflet anchor sutures 310 from one or more leaflet anchors 524 are provided on leaflet 9. Figures 47-49B are a series of views of a method of providing a suture lock, according to one embodiment. Suture lock 270 is operable to tie the respective sutures.

[0273] 47 is a cross-sectional view of the heart 4 with a suture lock delivery subsystem 530 operable for deployment of the suture lock 270. The suture lock delivery subsystem 530 for the suture lock 270 can be delivered through a delivery catheter distal end 502 of a delivery catheter 500, which in this embodiment is disposed within the atrium, without limitation. The suture lock 270 can be delivered to engage the pericardial anchor suture 280 to the pericardial anchor suture tail 313, as shown in FIG. 21, or the one or more leaflet anchor sutures 310 to the one or more leaflet anchor suture tails 319, as shown in FIG. 23. Tension is applied to the pericardial anchor suture 280 to provide a predetermined tension between the pericardial anchor system 200 and the leaflet anchor 524. The suture lock 270 can then be locked to maintain the desired tension.

[0274] FIG. 48A is a cross-sectional view of heart 4 with suture lock 270 in anchor socket 260 of pericardial anchor system 200. Suture lock 270 can then be placed in anchor socket 260 as a rail to guide pericardial anchor suture 280 into anchor socket 260. According to one embodiment, ventricular anchor suture and leaflet anchor suture are fed through the suture lock, and the suture lock is tracked to the ventricular anchor by using the ventricular anchor suture as a rail. The transmyocardial anchor accordions in the process of lowering the lock to the heart wall. After a predetermined tension is applied to the leaflet anchor to correct the function of the leaflet, the sutures are locked together. According to another embodiment, the anchor suture is tensioned, the transmyocardial anchor pledget is tightened, the leaflet anchor is tensioned, and then the sutures are tied together. FIG. 48B is a cross-sectional view of heart wall 41 with suture lock 270 positioned within anchor socket 260 of pericardial anchor system 200.

[0275] 49A is a cross-sectional view of heart 4 with anchor socket 260 of pericardial anchor system 200 positioned against heart wall 41, according to one embodiment. According to one embodiment, pericardial anchor system 200 does not include anchor socket 260, and suture lock 270 is operable to affect tissue ingrowth. FIG. 49B is a cross-sectional view of heart wall 41 with pericardial anchor system 200. Suture lock 270 positioned within anchor socket 260 may be further lowered to be positioned against heart wall 41, such that excess length of transmyocardial pledget 240 may be folded or collapsed against heart wall 41. Suture lock 270 positioned within anchor socket 260 may be positioned against the folded portion of transmyocardial pledget 240. The suture lock 270 surrounded by the anchor socket 260 may also drive the anchor socket 260 to the endocardial surface and facilitate sealing of the puncture on the endocardial surface with the folded portion of the transmyocardial pledget 240. As shown in Figures 49A-49B, a portion of the transmyocardial pledget 240 is collapsed and compressed between the suture lock 270 disposed within the anchor socket 260 and the heart wall 41. The suture lock delivery subsystem 530 for delivering the suture lock 270 may then be withdrawn through the delivery catheter 500.

[0276] Once the suture lock 270 is delivered to the target location within the anchor socket 260, a suture cutter 542 can be provided to cut the suture tails of one or more leaflet anchor sutures 310 and the suture tails of the pericardial anchor suture 280. FIGS. 50-52 are a series of views of a method of providing a suture cutter, according to one embodiment. FIG. 50 is a cross-sectional view of a heart with a suture cutter 542. A delivery subsystem 540 can be provided and delivered through a delivery catheter 500. The delivery subsystem 540 can be a catheter configured to extend distally from the delivery catheter 500. The delivery subsystem 540 can provide and deliver the suture cutter 542. The suture cutter 542 can rail down over the sutures 280, 310 toward the suture lock 270. The suture cutter 542 can cut off the excess suture tails of the sutures 280, 310 after the sutures 280, 310 are tensioned by the suture lock 270. Figure 51 is a cross-sectional view of the heart with the suture cutter 542 withdrawn. The suture cutter 542 can then be withdrawn from the heart through the delivery catheter 500. Figure 52 is a cross-sectional view of the heart with the delivery catheter withdrawn. The delivery catheter 500 can then be withdrawn from the heart.

[0277] Figure 53A is a cross-sectional view of a heart provided with multiple leaflet anchors 524. Figure 53B is a cross-sectional view of a heart with multiple leaflet anchor sutures 310. As previously described, multiple leaflet anchors 524 can be provided and implanted into the leaflets 9. Each of the multiple leaflet anchors 524 can have a leaflet anchor suture 310 connected to a pericardial anchor system 200 as described herein.

[0278] In accordance with other embodiments, the present disclosure relates to apparatus, systems and methods for placement of hardware, devices or therapeutics in the pericardial space from the ventricular side of the heart. Although the present disclosure describes the embodiments herein with respect to locations within the patient's blood vessels and chambers, the embodiments are applicable to placement in the pericardial space from many approaches, including modifications of current methods performed percutaneously from outside the chest or abdomen.

[0279] When a tool is used for placement of a device or therapeutic procedure within the pericardial space, the present disclosure may be performed using echocardiography and / or fluoroscopy, and the deployment of the tool and its use may be permanent or reversible.

[0280] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of some embodiments. However, one skilled in the art will appreciate that some embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, units and / or circuits have not been described in detail so as not to obscure the discussion.

[0281] The present disclosure relates to systems and methods for placing hardware, devices or therapeutics from a ventricle of the heart into the pericardial space using an endovascular approach, which may be necessary when a procedure is required for the treatment of valvular disease, ventricular dilation, ischemic heart disease, congenital lesions, heart failure or structural heart disease. According to one embodiment, a pericardial access and fixation tool (herein referred to as tool) is provided operative to deploy within the myocardium and extend from the ventricular side of the heart into the pericardial space. These embodiments allow for traversing the myocardium while minimizing the risk or extent of myocardial damage, bleeding or undesired placement.

[0282] 54A and 54B are side and cross-sectional views, respectively, of a tool 150 according to one embodiment. An embodiment of the tool 150 can be used with a small bore (approximately 0.018 inch diameter) catheter-based delivery system, referred to as a delivery catheter system 50, but may be larger or smaller using the same components depending on the intended use. According to one embodiment, the tool 150 includes a body 170 and a head 160, where the body 170 is operable to be deployed into the myocardium and the head 160 is operable to extend from the myocardium into the pericardial space 10. According to this embodiment, the head 160 includes movable elements. According to one embodiment, these movable elements are operable to expand the pericardial space 10 during and / or after deployment of the tool 150. According to one embodiment, these movable elements are operable to secure the tool 150 within the pericardial space 10 after placement of the tool 150. According to one embodiment, body 170 defines a lumen 172 and head 160 defines an eyelet 124 in fluid communication with lumen 172, the lumen 172 and eyelet 174 operable to provide fluid communication between the ventricle 22 and the pericardial cavity 10. The combination of lumen 172 and eyelet 124 is referred to as an access channel 176. According to one embodiment, access channel 176, which is operable to provide fluid communication between the ventricle 22 and the pericardial cavity 10, is operable to facilitate confirmation of placement of tool 150 within pericardial cavity 10 as well as to facilitate passage of a wire, catheter or device from the ventricular side of heart 2 into pericardial cavity 10.

[0283] According to one embodiment, the access channel 176 can include an occlusion element 175 operable to occlude or stop fluid communication through the access channel 176. According to one embodiment, the eyelet 174 includes a resilient material operable to open under the force of an object or fluid or gas pressure passing through the lumen 172 and to close fluid communication with the lumen 172 when the object or fluid or gas pressure is not present at the eyelet 174. In another embodiment, the eyelet 174 further includes a flap operable to open under the force of an object or fluid or gas pressure and to close fluid communication with the lumen 172 when the object or fluid or gas pressure is not present at the eyelet 174.

[0284] According to an embodiment, movable member 161 can be an anchor extension member 162 and / or an anchor apposition member 164.

[0285] Anchor extension member 162 provides a progressive transverse profile in the pre-deployed configuration and is operable to support the parietal pericardium as anchor extension member 162 expands or moves to the deployed configuration.

[0286] Anchor apposition member 164 provides a progressive transverse profile in a pre-deployed configuration and is operable to support against visceral pericardium 19 when anchor apposition member 164 is moved to the expanded or deployed configuration within pericardial space 10. In one embodiment, movable member 161 is operable to function as both anchor extension member 162 and anchor apposition member 164, i.e., they are one and the same.

[0287] The body 170 is operable to occupy the transverse segment 28 after crossing the myocardium to maintain hemostasis. As described below, the heart wall 4 is punctured by the needle 56 and / or the tool 150 from the ventricular side to the pericardial cavity 10 side while the tool 150 is deployed. The heart wall channel drilled or created in the heart wall 4 is referred to herein as the transverse segment 28.

[0288] Tool 150 further includes a retention element 180 operable to retain tool 150 within the heart wall 4 and / or as a means for coupling to other treatment devices. According to one embodiment, retention element 180 is a biocompatible cord or similar member to which a treatment device (e.g., a valve repair, heart failure repair or replacement prosthesis) may be coupled.

[0289] 55B is a cross-sectional view of tool 150 showing actuation mechanism 58 operable to extend and / or retract movable members 161, according to one embodiment. According to one embodiment, actuation mechanism 58 is a cable or lever member operable to lift movable members 161 for movement to the deployed configuration once head 160 is in a desired position. These movable members 161, according to one embodiment, are operable to act as anchors after deployment.

[0290] The delivery catheter system 50 is operable to deliver the tool to a desired location. According to one embodiment, the delivery catheter system 50 includes steerable catheters 51, 53 that can receive the heart wall 4, a head 160 extending therefrom, and a delivery catheter 55 operable to position and deploy the tool 150 with a body 170 within the pericardial space 10. FIG. 54C is a cross-sectional view of the left ventricle 22 and mitral valve 8 showing the delivery catheter system 50 for positioning the tool 150, according to one embodiment. The delivery catheter system 50 includes steerable catheters 51, 53 positioned from a transvenous transseptal approach to enter the left ventricle 22 beyond the mitral valve, followed by pericardial access. Each of these steerable catheters 51, 53 includes cables for steering in multiple directions to achieve perpendicularity to the myocardium or a preferred trajectory for the implanted treatment, as shown in FIG. 54D. FIG. 54D is a cross-sectional view of the left ventricle 22 showing the delivery catheter distal end 52. The delivery catheter system 50 can be in either a single, in-line or nested configuration. Although the figures show a transvenous transseptal approach, the delivery catheter system 50 and tools 150 may be similarly used using a transatrial or transaortic approach. Similarly, the delivery catheter system 50 may be inserted into the pericardial space 10 from either atrium and either ventricle 22.

[0291] According to one embodiment, the delivery catheter system 50 includes a guidewire 54 and a needle 56, alone or in combination, operable to provide support for traversing the myocardium and puncturing the visceral pericardium 19. The needle 56 may be coupled or integrated with the guidewire 54, which may be advanced into the pericardial space 10 after puncturing the visceral pericardium 19 to facilitate subsequent catheter exchanges, as shown in FIG.

[0292] 55A-55I illustrate a delivery procedure of a tool 150 using a delivery catheter system 50, according to one embodiment. FIG 55A is a cross-sectional view of a heart 2 showing a delivery catheter system 50 positioned adjacent to an endocardium 11, according to one embodiment. As shown in FIG 55A, a steerable guide catheter 55 is steered to the target site, facing the surface of the endocardium 11. A trajectory is established through steering of the different steerable catheters 51, 53, 55 while being confirmed by echocardiography, fluoroscopy or other equivalent imaging methodology.

[0293] The tool 150 is then advanced through the myocardium 13. FIG. 55B is a cross-sectional view of the heart 2 showing the tool 150 traversing the endocardium 11 and myocardium 13 with the aid of the needle 56 for placement within the myocardium 13 and pericardial space 10 during the deployment process, according to one embodiment. This advancement may be assisted by the use of the needle 56 as well as electrical energy, cryoablation, radiofrequency or mechanical force. In at least one embodiment, the tool 150 utilizes a mechanical method with the needle 56 to traverse the myocardium with a stylet to reduce coring of tissue. In at least one other embodiment, the tool 150 uses radiofrequency energy or cauterization. In at least one other embodiment, the tool 150 has a sharp end, beveled or non-beveled, to facilitate traversal, with or without a support needle 56 or guidewire 54. In at least one other embodiment, rotation of the tool 150 facilitates traversal of the myocardium. These embodiments allow for traversing the myocardium while minimizing the risk or extent of myocardial damage, bleeding or placement in an undesirable location. The tool 150 is advanced to the visceral pericardium 19 and gently traversed across it.

[0294] FIG. 55C is a cross-sectional view of the heart 2 showing the tool 150 traversing the epicardium 14 for placement in the myocardium 13 and pericardial cavity 10 during the deployment process, according to one embodiment. Upon traversing the visceral pericardium 19, the eyelet 174 is positioned within the pericardial cavity 10 without traversing the parietal pericardial layer. This placement is made possible by the bluntness of the tip of the tool 150, the relatively stiff compliance of the parietal pericardial layer, and the potential space between the visceral pericardium 19 and the parietal lamina. In at least one embodiment, a signal from the eyelet 174, such as by, but not limited to, fluid pressure or electrical impedance, is monitored to determine whether the visceral pericardium 19 has been traversed and the head 160 of the tool 150 is located within the pericardial cavity 10. FIG. 55D is a cross-sectional view of the heart 2 showing the tool 150 enlarging the pericardial cavity 10 during the deployment process, according to one embodiment. According to one embodiment, confirmation of position can also be obtained through injection of a contrast agent or imaging material, as shown in FIG. 55D. Injection of these substances can serve to expand the pericardial cavity 10 as the tool 150 is advanced.

[0295] In some embodiments, the eyelet 174 facilitates confirmation of placement within the pericardial space 10 as well as the passage of wires, catheters or devices into the pericardial space 10. The eyelet 174 can be used to transmit fluid or wall pressure and also to provide contrast or visualization agents. The eyelet 174 can also be used to inject and expand material (e.g., gas, fluid, or mechanical dilator) into the pericardial space 10 to then facilitate placement of the device. In at least one embodiment, the eyelet 174 is at the distal end of the tool 150 and faces the pericardial space 10 in either an orthogonal, perpendicular or oblique orientation to the pericardial surface. In at least one embodiment, the eyelet 174 can be positioned more proximally or along the length of the head 160 of the tool 150. In other embodiments, the eyelet 174 can be oval, circular, square, rectangular or another geometric shape and size. In other embodiments, there may be multiple eyelets 174 , some or all of which are in fluid communication with one or more lumens 172 within body 170 .

[0296] 55E is a cross-sectional view of heart 2 showing the moveable elements of tool 150 expanding pericardial space 10 during the deployment process, according to one embodiment. As shown in FIG. 55E, once tool 150 has been advanced into pericardial space 10, anchor extension members 162 are released, according to an embodiment, by either retracting or de-sheathing a retaining cable or similar element. These anchor extension members 162 become blunter and are operable to generate a force pushing against the parietal pericardial layer to expand pericardial space 10. This expansion allows larger elements to be advanced into pericardial space 10 as needed.

[0297] In some embodiments, tool 150 includes movable elements that aid in the expansion of pericardial space 10 as tool 150 is advanced. In at least one embodiment, head 160 defines these movable elements at or near the distal end of tool 150 and are controlled by cables or push / pull rods. In at least one embodiment, the movable elements contribute to the expansion and fixation of pericardial space 10.

[0298] FIG. 55F is a cross-sectional view of the heart 2 showing the movable elements of the tool 150 engaging the epicardium 14 and / or pericardium 18 to secure the tool 150 within the pericardial space 10, according to one embodiment. As shown in FIG. 55F, the anchor extension member 162 can be expanded or retracted as the tool 150 is advanced to create more space within the pericardial space 10. Once the head 160 of the tool 150 is positioned within the pericardial space 10, the anchor apposition member 164 is expanded or deployed as shown in FIG. 55G. FIG. 55G is a cross-sectional view of the heart 2 showing the movable elements of the tool 150 engaging the epicardium 14 and / or pericardium 18 to secure the tool 150 within the pericardial space 10, according to one embodiment. The head 160 of the tool 150, including the movable elements, can be retracted, rotated, or recaptured for placement on the surface of the visceral pericardium 19 (i.e., the epicardium). FIG. 55H is a top view of head 160 showing the placement of movable members 161 in a deployed configuration, in this embodiment, expanded anchor apposition members 164 and anchor extension members 162, according to one embodiment.

[0299] Once satisfactory placement is achieved, the epicardial anchor tool 150 is detached from the delivery catheter system 50. The tool 150 is retained by engagement of a retaining element 180 which cooperatively engages with a head 160 of the tool 150, allowing the tool 150 to remain within the myocardium and extend into the pericardial cavity 10 for use. According to one embodiment, the eyelet 174 can be closed to prevent fluid communication between the ventricle 22 and the pericardial cavity 10 by an occlusion element 175.

[0300] 56A1-56D2 show different configurations of anchor extension members 162 and anchor apposition members 164. They can be symmetrical, asymmetrical, have different lengths, be concave or convex, have different pads and sizes, and be offset or perpendicular.

[0301] In some embodiments, similar methods described herein for use of tool 150 to access the pericardial space 10 can also be used to place devices, anchors or therapeutic procedures on the surface of the parietal pericardium.

[0302] The inventive features of the present disclosure have been described above both generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Thus, it is intended that the embodiments cover the modifications and variations of the present disclosure provided they come within the scope of the appended claims and their equivalents. The present disclosure further includes the following aspects: Aspect 1 Anchor, and a tether coupled to the anchor; wherein the anchor is operable to have a low profile in a first position and a larger profile in a second position, the anchor being operable to advance from a cardiac chamber of the heart through a narrow access channel in a heart wall at the first position into a pericardial cavity and to expand within the pericardial cavity to a second position to a size larger than the narrow access channel. Aspect 2 The anchor is a wire having a first end and a second end, the wire having a shape memory property configured into a ring shape, the first end of the wire opposing the second end of the wire; a skirt coupled to the wire along an edge defining a length; and a plurality of apertures along an edge of said skirt opposite said wires; Including, the tether is interleaved through the plurality of apertures, the tether defining a first end of the tether and a second end of the tether; and The anchor system of embodiment 1, wherein the first end of the tether and the second end of the tether are operable to tension the skirt to tighten into a disk-like shape when the wire is in a ring configuration in a deployed configuration, and the first end of the tether and the second end of the tether can be tensioned to straighten the wire into a straight configuration in a pre-deployed configuration. Aspect 3 3. The anchor system of embodiment 2, wherein the first end of the wire and the second end of the wire are operable to securely couple to one another when in the ring configuration. Aspect 4 The anchor system of aspect 2, wherein the first end of the wire and the second end of the wire are operable to engage such that the first end of the wire and the second end of the wire do not overlap beyond a complete loop of the wire when in the ring configuration. Aspect 5 3. The anchor system of embodiment 2, wherein the skirt has tissue ingrowth properties on one side and tissue anti-adhesion properties on the other side. Aspect 6 3. The anchor system of embodiment 2, further comprising a tether lock slidably coupled to the tether operable to slide along the tether and operable to lock in place to capture tissue between the tether lock and the anchor. Aspect 7 7. The anchor system of embodiment 6, further comprising a tether lock nesting element slidably coupled to the tether operable to slide along and receive the tether therein. Aspect 8 Providing an anchoring system according to any one of aspects 2 to 7; advancing a guidewire into the femoral vein; advancing said guidewire through the femoral vein and into the right atrium; advancing the guidewire through the septum and into the left atrium; advancing the guidewire adjacent to the heart wall through the mitral valve to the heart wall of the left ventricle; advancing a needle catheter over the guidewire through the endocardium of the heart wall and into the myocardium; advancing the guidewire through the needle catheter, through the myocardium, through the epicardium and into the pericardial space; withdrawing the needle catheter from the guidewire; advancing a catheter over said guidewire into the pericardial space; Inflating the pericardium and separating it from the heart wall to enlarge the pericardial cavity; advancing the anchoring system over the guidewire or through the catheter, where the anchor is disposed within the pericardial space; deploying an anchor of the anchoring system within the pericardial space and positioning the anchor against the epicardium, where the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and where the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether; removing the guidewire and / or catheter from the patient, leaving the tether attached to the anchor within the heart chamber; A fixing method comprising: Aspect 9: Providing an anchoring system according to any one of aspects 2 to 7; advancing the guidewire into the needle catheter such that the distal tip of the guidewire is adjacent the distal tip of the needle catheter; advancing the distal tip of the needle catheter from the heart chamber through the endocardium of the heart wall and into the myocardium; advancing the distal tip of the guidewire through the myocardium and epicardium into the pericardial space; and advancing an anchor of the anchoring system over the guidewire into the pericardial space; deploying the anchor within the pericardial space; Including, The anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether. Aspect 10 Providing an anchoring system according to any one of aspects 2 to 7; advancing a support catheter into the heart up to, adjacent to, or against a wall of the heart; advancing an anchor catheter alone or through the support catheter and forcing it into engagement with and into position against the heart wall; advancing a guidewire along or through the anchor catheter, through the endocardium of the heart wall, through the myocardium, through the epicardium (the visceral layer of the serous pericardium) and into the pericardial space; advancing the anchor catheter along or over the guidewire through the endocardium of the heart wall, through the myocardium, through the epicardium (the visceral layer of the serous pericardium) and into the pericardial space; advancing or exposing an anchor of the anchoring system through or to a distal end of the anchoring catheter within the pericardial space, where the anchor is disposed within the pericardial space; deploying an anchor of the anchoring system into the pericardial space and positioning the anchor against the epicardium, where the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether; and removing the guidewire and anchor catheter from the patient, leaving the tether coupled to the anchor within the heart chamber; A fixing method comprising: Aspect 11 Providing an anchoring system according to any one of aspects 2 to 7; advancing the anchor catheter against the heart wall to the heart wall within the heart chamber; advancing a guidewire through the anchor catheter such that a distal tip of the guidewire is advanced through the endocardium into the myocardium and through the epicardium into the pericardial space; advancing a distal tip of the anchor catheter along or over the guidewire into or adjacent to the pericardial space; advancing or exposing an anchor of the anchoring system through or at a distal end of the anchoring catheter within the pericardial space, where the anchor is disposed within the pericardial space; deploying an anchor of the anchoring system into the pericardial space and positioning the anchor against the epicardium, where the anchor is in a straight configuration in a pre-deployed configuration due to tension on the first end of the tether and the second end of the tether, and the anchor is in a ring-shaped configuration in a deployed configuration due to tension on the first end of the tether and the second end of the tether; and removing the guidewire and anchor catheter from the patient, leaving the tether attached to the anchor over the guidewire and in the pericardial space within the heart chamber of the anchoring system; A fixing method comprising: Aspect 12 an epicardial anchor including a skirt; Transmyocardial pledgets, a pericardial anchor suture coupled to said epicardial anchor and said transmyocardial pledget; Suture lock, and an anchor socket configured to restrain and dock said suture lock; 1. A pericardial anchor system comprising: at least one leaflet anchor coupled to a leaflet anchor suture, wherein the suture lock is configured to secure the pericardial anchor suture and the leaflet anchor suture; 1. A mitral valve chordae repair system comprising: Aspect 13 A mitral valve chordae tendineae repair system as described in aspect 12, wherein the epicardial anchor is configured to form a disk shape in a deployed configuration. Aspect 14 The mitral valve chordae tendineae repair system of aspect 12, wherein the epicardial anchor is configured to form a curved shape, compressed shape, bundle, mass or knot in the deployed configuration. Aspect 15 The mitral valve chordae repair system of aspect 12, wherein the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a compressed configuration. Aspect 16 The mitral valve chordae tendineae repair system of aspect 12, wherein the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a coiled configuration. Aspect 17 The mitral valve chordae tendineae repair system of aspect 12, wherein the epicardial anchor has a free end in a pre-deployed configuration, and the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form the deployed configuration. Aspect 18 The mitral valve chordae tendineae repair system of aspect 12, wherein the epicardial anchor further comprises a wire frame, the wire frame being covered by the skirt. Aspect 19 A mitral valve chordae tendineae repair system as described in aspect 18, wherein the wire frame of the epicardial anchor has shape memory properties that are shaped into a deployed configuration. Aspect 20 A mitral valve chordae tendineae repair system as described in aspect 18, wherein the skirt is configured to slidably receive the pericardial anchor suture, and the pericardial anchor suture is operable to be tensioned to tighten the skirt in a deployed configuration. Aspect 21 A mitral valve chordae repair system as described in aspect 18, wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, the skirt including a plurality of apertures along the edge of the skirt opposite the wire frame, the pericardial anchor sutures being woven alternately through the plurality of apertures, and the pericardial anchor sutures are operable to be tensioned to tighten the skirt in a deployed configuration. Aspect 22 A mitral valve chordae tendineae repair system as described in aspect 18, wherein the wire frame of the epicardial anchor further includes a proximal leg, the proximal leg being configured to be straight and centrally located in the epicardial anchor in a deployed configuration. Aspect 23 23. The mitral valve chordae repair system of aspect 22, wherein the transmyocardial pledget extends from a proximal leg of the epicardial anchor. Aspect 24 23. The mitral valve chordae repair system of claim 22, wherein the proximal leg comprises two portions of the same wire doubled so that the two portions are parallel to each other. Aspect 25 A mitral valve chordae tendineae repair system as described in aspect 12, wherein the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, by proximal retraction of the pericardial anchor suture. Aspect 26 A mitral valve chordae tendineae repair system as described in aspect 18, wherein the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, due to shape memory properties of a wire frame shaped into the deployed configuration. Aspect 27 The mitral valve chordae tendineae repair system of embodiment 18, wherein the first end of the wire frame and the second end of the wire frame each comprise an atraumatic end. Aspect 28 The mitral valve chordae tendineae repair system of embodiment 12, wherein the transmyocardial pledget comprises a film having a tubular structure. Aspect 29 30. The mitral valve chordae repair system of claim 28, wherein the pericardial anchor sutures are woven through a plurality of apertures through the transmyocardial pledget film. Aspect 30 13. The mitral valve chordae tendineae repair system of claim 12, wherein the anchor socket comprises a self-expanding frame covered with a film. Aspect 31 an epicardial anchor including a skirt; a transmyocardial pledget extending from a proximal portion of said epicardial anchor; a pericardial anchor suture coupled to said epicardial anchor and said transmyocardial pledget; a suture lock configured to secure the pericardial anchor suture; and an anchor socket configured to restrain and dock said suture lock; 1. A pericardial anchor system comprising: A pericardial anchor system, wherein the epicardial anchor is configured to be transformable between a pre-deployed configuration and a deployed configuration. Aspect 32 The pericardial anchor system of aspect 31, wherein the epicardial anchor is configured to form a disk shape in a deployed configuration. Aspect 33 The pericardial anchor system of aspect 31, wherein the epicardial anchor is configured to form a curved shape, compressed shape, bundle, mass, or knot in a deployed configuration. Aspect 34 The pericardial anchor system of embodiment 31, wherein the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a compressed configuration. Aspect 35 The pericardial anchor system of embodiment 31, wherein the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a coiled configuration. Aspect 36 The pericardial anchor system of aspect 31, wherein the epicardial anchor has a free end in a pre-deployed configuration, and the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form the deployed configuration. Aspect 37 The pericardial anchor system of embodiment 31, wherein the epicardial anchor further comprises a wire frame, the wire frame being covered with a skirt. Aspect 38 A pericardial anchor system as described in aspect 37, wherein the wire frame of the epicardial anchor has shape memory properties that are shaped into a deployed configuration. Aspect 39 A pericardial anchor system as described in aspect 31, wherein the skirt is configured to slidably receive the pericardial anchor suture, and the pericardial anchor suture is operable to be tensioned to tighten the skirt in a deployed configuration. Aspect 40 38. The pericardial anchor system of claim 37, wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, the skirt including a plurality of apertures along an edge of the skirt opposite the wire frame, the pericardial anchor sutures being woven alternately through the plurality of apertures, and the pericardial anchor sutures are operable to be tensioned to tighten the skirt in a deployed configuration. Aspect 41 A pericardial anchor system as described in aspect 37, wherein the wire frame of the epicardial anchor further includes a proximal leg, the proximal leg being configured to be straight and centrally located in the epicardial anchor in a deployed configuration. Aspect 42 42. The pericardial anchor system of embodiment 41, wherein the transmyocardial pledget extends from a proximal leg of the epicardial anchor. Aspect 43 42. The pericardial anchor system of claim 41 , wherein the proximal leg comprises two portions of the same wire doubled so that the two portions are parallel to each other. Aspect 44 The pericardial anchor system of aspect 31, wherein the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, by proximal retraction of the pericardial anchor suture. Aspect 45 A pericardial anchor system as described in aspect 37, wherein the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, due to shape memory properties of a wire frame shaped into the deployed configuration. Aspect 46 38. The pericardial anchor system of claim 37, wherein the first end of the wire frame and the second end of the wire frame each include an atraumatic end. Aspect 47 The pericardial anchor system of embodiment 46, wherein the atraumatic end of each of the first end of the wire frame and the second end of the wire frame includes an eyelet. Aspect 48 32. The pericardial anchor system of embodiment 31, wherein the transmyocardial pledget comprises a film having a tubular structure. Aspect 49 The pericardial anchor system of embodiment 48, wherein the pericardial anchor sutures are woven through a plurality of apertures through the transmyocardial pledget film. Aspect 50 Skirt, and a pericardial anchor suture coupled to the skirt; 1. An epicardial anchor comprising: an epicardial anchor configured to be transformable between a pre-deployed configuration and a deployed configuration. Aspect 51 The epicardial anchor of aspect 50, wherein the epicardial anchor is configured to form a disk shape in a deployed configuration. Aspect 52 The epicardial anchor of aspect 50, wherein the epicardial anchor is configured to form a curved shape, compressed shape, bundle, mass, or knot in a deployed configuration. Aspect 53 The epicardial anchor of embodiment 50, wherein the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a compressed configuration. Aspect 54 The epicardial anchor of embodiment 50, wherein the pre-deployed configuration comprises an elongated configuration and the deployed configuration comprises a coiled configuration. Aspect 55 The epicardial anchor of embodiment 50, wherein the epicardial anchor has a free end in a pre-deployed configuration, and the epicardial anchor is configured to coil starting from the free end of the epicardial anchor to form the deployed configuration. Aspect 56 The epicardial anchor of embodiment 50, wherein the epicardial anchor further comprises a wire frame, the wire frame being covered by the skirt. Aspect 57 57. The epicardial anchor of claim 56, wherein the wire frame of the epicardial anchor has shape memory properties that are shaped into a deployed configuration. Aspect 58 57. The epicardial anchor of claim 56, wherein the skirt is configured to slidably receive the pericardial anchor suture, and the pericardial anchor suture is operable to be tensioned to tighten the skirt in a deployed configuration. Aspect 59 57. The epicardial anchor of claim 56, wherein the skirt of the epicardial anchor is coupled to the wire frame along an edge defining a length, the skirt including a plurality of apertures along the edge of the skirt opposite the wire frame, the pericardial anchor sutures being woven alternately through the plurality of apertures, and the pericardial anchor sutures are operable to be tensioned to tighten the skirt in a deployed configuration. Aspect 60 57. The epicardial anchor of claim 56, wherein the wire frame of the epicardial anchor further includes a proximal leg, the proximal leg being configured to be straight and centrally located in the epicardial anchor in a deployed configuration. Aspect 61 61. The epicardial anchor of embodiment 60, wherein the proximal leg comprises two portions of the same wire doubled so that the two portions are parallel to each other. Aspect 62 The epicardial anchor of embodiment 60, wherein the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, by proximal retraction of the pericardial anchor suture. Aspect 63 The epicardial anchor of embodiment 56, wherein the epicardial anchor is transformable between a pre-deployed configuration and a deployed configuration, at least in part, due to shape memory properties of a wire frame shaped into the deployed configuration. Aspect 64 57. The epicardial anchor of embodiment 56, wherein the first end of the wire frame and the second end of the wire frame each include an atraumatic end. Aspect 65 65. The epicardial anchor of embodiment 64, wherein each atraumatic end of the first end of the wire frame and the second end of the wire frame includes an eyelet. Aspect 66 advancing an epicardial anchor in a pre-deployed configuration constrained within an anchor catheter into a pericardial space of the heart; advancing the anchor catheter tangentially within the pericardial space a predetermined distance to desheath the epicardial anchor in a pre-deployed configuration; and retracting the anchor catheter to at least partially deploy the epicardial anchor into a deployed configuration within the pericardial space; 23. A method for securing a pericardial anchor system comprising: Aspect 67 67. The method of embodiment 66, wherein the predetermined distance comprises at least 10 cm. Aspect 68 The method of embodiment 66, wherein the anchor catheter is configured to move in a medial-lateral and / or inferior-superior direction within the pericardial space. Aspect 69 67. The method of embodiment 66, further comprising positioning a proximal leg of the epicardial anchor between the epicardium and the distal tip of the anchor catheter to maintain the position of the epicardial anchor within the pericardial space. Aspect 70 67. The method of embodiment 66, further comprising applying tension to a pericardial anchor suture of the pericardial anchor system to at least partially transform the epicardial anchor into a deployed configuration. Aspect 71 The method of embodiment 66, wherein the epicardial anchor is further transformed into the deployed configuration, at least in part, due to shape memory properties of a wireframe of the epicardial anchor that is shaped into the deployed configuration. Aspect 72 advancing a support sheath against the heart wall within the heart chamber; advancing a guidewire through the support sheath such that a distal tip of the guidewire is advanced through the endocardium, myocardium, and epicardium and into the pericardial space; advancing the anchor sheath and the guidewire sheath together through the support sheath and over the guidewire into the pericardial space to form a puncture through the endocardium, myocardium and epicardium; maintaining the position of the guidewire sheath while retracting the anchor sheath and the support sheath together to deploy an epicardial anchor of the pericardial anchor system within the pericardial space, wherein the epicardial anchor is in a pre-deployed configuration while located within the anchor sheath. maintaining the position of the anchor sheath while retracting the guidewire sheath to form a T-bar between a proximal leg of a wire frame of the epicardial anchor and a distal tip of the anchor sheath; retracting the support sheath, the anchor sheath and the guidewire sheath together until the proximal leg is positioned against the epicardial puncture; maintaining the position of the guidewire sheath and retracting the anchor sheath and the support sheath together to deploy the epicardial anchor; and applying tension to a pericardial anchor suture of the pericardial anchor system to at least partially transform the epicardial anchor into a deployed configuration; 23. A method for securing a pericardial anchor system comprising: Aspect 73 A method of fixing a pericardial anchor system as described in aspect 72, wherein the epicardial anchor is further transformed into the deployed configuration, at least in part, due to the shape memory properties of a wire frame shaped into the deployed configuration. Aspect 74 A method of securing a pericardial anchor system as described in aspect 72, further comprising maintaining the position of the guidewire sheath and retracting the support sheath and the anchor sheath to deploy a transmyocardial pledget and anchor socket of the pericardial anchor system, wherein a first portion of the transmyocardial pledget is positioned within the epicardial, myocardial and endocardial puncture and a second portion of the transmyocardial pledget extends proximally from the endocardial puncture. Aspect 75 75. A method of securing a pericardial anchor system as described in embodiment 74, further comprising folding a second portion of the transmyocardial pledget against the endocardial puncture. Aspect 76 A method of securing the pericardial anchor system of aspect 74, further comprising advancing a suture lock into the anchor socket and advancing the suture lock within the anchor socket toward the endocardium to fold a second portion of the transmyocardial pledget. Aspect 77 A method of securing a pericardial anchor system as described in aspect 75, wherein the film-covered proximal leg of the epicardial anchor is configured to seal the epicardial puncture, a first portion of the transmyocardial pledget is configured to seal the myocardial puncture, and a folded second portion of the transmyocardial pledget is configured to seal the endocardial puncture. Aspect 78 A tool for placement in the heart wall and pericardial cavity operable to provide access to the pericardial space from the heart chamber and / or to act as an anchor for an associated device, comprising: a body defining a lumen operable to extend through a wall of the heart; a head at a distal end of the body operable to extend into the pericardial cavity, the head including a movable element operable to move from a low profile pre-deployed configuration to a high profile deployed configuration, the head defining an eyelet in fluid communication with the lumen to define an access channel operable to provide a fluid passage between the heart chamber and the pericardial cavity; a base further comprising a retention member operable to retain the base against the heart wall; Including, tools. Aspect 79 The tool of aspect 78, wherein the movable element is operable to support the parietal pericardium when the movable member reaches a high profile in the deployed configuration, and the retaining member cooperates to abut and engage the movable element against the parietal pericardium. Aspect 80 The tool of aspects 78 and 79, wherein the movable element includes an expansion member operable to abut against the pericardium to enlarge the pericardial cavity. Aspect 81 A tool as described in aspects 78 and 79, wherein the eyelet is operable to evacuate or extract fluid or gas from the pericardial cavity using a device in communication with the lumen. Aspect 82 79. The tool of embodiment 78, wherein the eyelet is operable to be a pressure port operable to measure pressure with a pressure sensing device. Aspect 83 A tool described in any one of aspects 78-82, wherein the access channel is operable to receive a device and allow passage of the device between the ventricular side of the heart and the pericardial cavity. Aspect 84 A tool described in any one of aspects 78 to 82, wherein the eyelet is operable to elastically deform between an open configuration and a closed configuration, and in the closed configuration, the access channel is blocked to prevent fluid passage through the access channel. Aspect 85 A tool described in any one of aspects 78 to 82, wherein the head further includes an obstruction element operable to move elastically between an open position and a closed position, wherein in the closed position, the access channel is obstructed to prevent fluid passage through the access channel. Aspect 86 A tool described in any one of aspects 78-82, further comprising a blocking plug operable to be positioned within the access channel to block the access channel and prevent fluid passage therethrough. Aspect 87 The tool of any one of aspects 78-83, wherein the tool is operable to couple with another device or cardiac tissue. Aspect 88 To provide a delivery system operable for endovascular epicardial access, the delivery system including a steerable catheter and a delivery catheter; inserting the delivery system into the patient using a transvenous, transarterial, transseptal, transatrial or transaortic approach; advancing the delivery catheter having the tool associated therewith into the myocardium; and extending the head of the tool into the pericardial space; A method for implanting a tool according to any one of aspects 78 to 87, comprising: Aspect 89 The delivery system further comprises a guidewire and / or a needle, and the method further comprises: advancing a guidewire or needle through the delivery catheter and extending through the tool into the myocardium and pericardial cavity, and advancing the tool over the guidewire or needle; 89. The method of embodiment 88, comprising:

Claims

1. An anchor, a wire having a first wire end and a second wire end, the wire having a shape memory property configured to be set into a ring shape; a skirt coupled to the wire along an edge defining a length; and a plurality of apertures along an edge of said skirt opposite said wires; An anchor including, a tether coupled to the anchor; the anchor is operable to have a low profile in a first position and a larger profile in a second position, the anchor being operable to advance from a chamber of the heart through a narrow access channel in a heart wall at the first position into a pericardial space and to expand within the pericardial space to a second position to a size larger than the narrow access channel; the tether is interleaved through the plurality of apertures, the tether defining a first end of the tether and a second end of the tether; and the first end of the tether and the second end of the tether are operable to tension the wire to pinch the skirt into a disk-like shape when the wire is in a ring configuration in a deployed configuration, and the first end of the tether and the second end of the tether can be tensioned to straighten the wire into a straight configuration in a pre-deployed configuration. Anchor system.

2. The anchor system of claim 1 , wherein the first end of the wire and the second end of the wire are operable to securely couple to one another when in the ring configuration.

3. 2. The anchor system of claim 1, wherein the first end of the wire and the second end of the wire are operable to engage such that the first end of the wire and the second end of the wire do not overlap beyond a complete loop of the wire when in the ring configuration.

4. The anchor system of claim 1 , wherein the skirt has tissue ingrowth characteristics on one side and tissue anti-adhesion characteristics on the other side.

5. 10. The anchor system of claim 1, further comprising a tether lock slidably coupled to the tether operable to slide along the tether and operable to lock in place to capture tissue between the tether lock and the anchor.

6. The anchor system of claim 5 further comprising a tether lock nesting element slidably coupled to the tether operable to slide along and receive the tether therein.

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