Mitral Valve Leaflet Repair System

Abstract

Various aspects of the present disclosure relate to apparatus, systems and methods for cardiac device fixation, and more particularly to accessing and fixating the pericardial space.

Description

[Technical Field]

[0001] Incorporation of priority claims from priority applications This application claims priority to U.S. Provisional Application No. 63 / 318,080, filed October 26, 2022, the entirety of which is incorporated herein by reference for all purposes.

[0002] Any and all applications for which a foreign or domestic priority claim is identified in the PCT application filed with this application are incorporated herein by reference.

[0003] Field 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 secure medical devices within cardiac chambers. Typically, these devices may have anchors implanted in the myocardium. There remains a need for a more secure fixation system for such devices. Summary of the Invention

[0005] overview The described embodiments relate to devices, systems and methods for pericardial anchoring.

[0006] According to one example ("Example 1"), a fixation 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 cardiac chamber of the heart through a narrow access channel in a heart wall into a pericardial space at the first position and expand within the pericardial space to the 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 the heart wall; advancing a needle catheter over the guidewire, through the endocardium, into the myocardium of the heart wall; advancing the guidewire through the needle catheter, through the myocardium and epicardium (visceral layer 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 a fixation system either over the guidewire or through the catheter, wherein an anchor portion of the fixation system is positioned within the pericardial cavity; deploying anchors of the fixation system within the pericardial cavity and positioning the anchors against the epicardium; and removing the guidewire and / or the catheter from the patient, leaving a tether coupled to the anchor within the heart chamber.

[0008] According to another example ("Example 3"), a fixation method includes advancing a guidewire into the femoral vein, advancing the guidewire through the femoral vein into the right atrium, advancing the guidewire through the septum into the left atrium, advancing the guidewire through the mitral valve to and adjacent to the heart wall of the left ventricle, advancing a needle catheter over the guidewire through the endocardium into the myocardium of the heart wall, advancing the guidewire through the needle catheter through the myocardium and epicardium 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 and enlarging the pericardial space, advancing a fixation system either over the guidewire or through the catheter, wherein an anchor portion of the fixation system is positioned within the pericardial space, deploying an anchor of the fixation system within the pericardial space and positioning the anchor against the epicardium, and removing the guidewire and / or the catheter from the patient, leaving a tether coupled to the anchor within the heart chamber.

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

[0010] According to another example ("Example 5"), the fixation method includes: optionally advancing an optional support catheter into the heart, up to and adjacent to or against the heart wall; advancing an anchor catheter alone or through the optional support catheter and positioning it in forced engagement against or adjacent to the heart wall; advancing a guidewire through the anchor catheter, through the endocardium of the heart wall, through the myocardium, through the epicardium (visceral layer of the serous pericardium), and into the pericardial space; advancing the anchor catheter over the guidewire through the endocardium of the heart wall, through the myocardium, through the epicardium (visceral layer of the serous pericardium), and into the pericardial space. 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 a fixation system through or at or near the distal end of the anchor catheter within the pericardial space, wherein the anchor is disposed within the pericardial space; deploying the anchor of the fixation 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 ventricle.

[0011] According to another example ("Example 6"), a fixation method includes advancing an anchor catheter near or up to and against a heart wall within a heart chamber; advancing a guidewire through the anchor catheter such that a distal end of the guidewire enters the myocardium through the endocardium and enters the pericardial space through the epicardium; advancing the distal end of the anchor catheter along or over the guidewire into or adjacent to the pericardial space; advancing or exposing an anchor of a fixation system through or at the distal end of the anchor catheter within the pericardial space, wherein the anchor is positioned within the pericardial space; deploying the anchor of the fixation 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 fixation system and on the guidewire within the pericardial space.

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

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

[0014] According to another example ("Example 9"), the mitral valve chordae tendineae repair system of Example 7, 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.

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

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

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

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

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

[0020] According to another example ("Example 15"), the mitral valve chordae tendineae repair system of Example 13, wherein the skirt is configured to slidingly 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"), the mitral valve chordae tendineae repair system of Example 13, 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 interwoven alternately through the plurality of apertures, and the pericardial anchor sutures being operable to be tensioned to tighten the skirt in the deployed configuration.

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

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

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

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

[0026] According to another example ("Example 21"), the mitral valve chordae tendineae repair system of Example 13, wherein the epicardial anchor is deformable from the pre-deployment configuration to the post-deployment configuration, at least in part, due to a shape memory property of a wire frame shaped to the post-deployment configuration.

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

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

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

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

[0031] According to another example ("Example 26"), a pericardial fixation 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-deployment configuration and a post-deployment configuration.

[0032] According to another example ("Example 27"), the pericardial fixation 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"), the pericardial fixation system of Example 26, 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.

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

[0035] According to another example ("Example 30"), the pericardial fixation system of Example 26, wherein the pre-deployment configuration comprises an elongated configuration and the post-deployment configuration comprises a coiled configuration.

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

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

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

[0039] According to another example ("Example 34"), the pericardial fixation system of Example 26, wherein the skirt is configured to slidingly 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"), the pericardial fixation system of Example 32, 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 being operable to be tensioned to tighten the skirt in the deployed configuration.

[0041] According to another example ("Example 36"), the pericardial fixation system of Example 32, wherein the wire frame of the epicardial anchor further includes proximal legs, the proximal legs configured to remain straight in the deployed configuration and to be centered within the epicardial anchor.

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

[0043] According to another example ("Example 38"), the pericardial fixation system of Example 36, wherein the proximal leg includes two portions of the same wire folded in half, the two portions being parallel to each other.

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

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

[0046] According to another example ("Example 41"), the pericardial fixation system of Example 32, wherein 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"), the pericardial fixation system of Example 41, wherein each atraumatic end 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"), the pericardial fixation system of Example 26, wherein the transmyocardial pledget comprises a film having a tubular structure.

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

[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-deployment configuration and a post-deployment 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 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, wherein the pre-deployed configuration comprises an elongated configuration and the post-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 elongated configuration and the post-deployed configuration comprises a coiled configuration.

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

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

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

[0058] According to another example ("Example 53"), the epicardial anchor of Example 51, wherein the skirt is configured to slidingly 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"), there is provided an epicardial anchor of Example 51, wherein a 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 being operable to be tensioned to tighten the skirt in the deployed configuration.

[0060] According to another example ("Example 55"), there is provided an epicardial anchor of Example 51, wherein the wire frame of the epicardial anchor further includes proximal legs, the proximal legs being configured to remain straight in the deployed configuration and to be positioned at the center of the epicardial anchor.

[0061] According to another example ("Example 56"), the epicardial anchor of Example 55, wherein the proximal leg includes two portions of the same wire folded in half, the two portions being parallel to each other.

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

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

[0064] According to another example ("Example 59"), the epicardial anchor of Example 51, wherein 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"), the epicardial anchor of Example 64, wherein each atraumatic end 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 fixation system includes advancing an epicardial anchor in a pre-deployed configuration constrained within an anchor catheter into a pericardial cavity of a heart, advancing the anchor catheter tangentially within the pericardial cavity a predetermined distance so as to unsheath the epicardial anchor in the pre-deployed configuration, and retracting the anchor catheter to at least partially deploy the epicardial anchor in a post-deployed configuration within the pericardial cavity.

[0067] According to another example ("Example 62"), the method for fixing the pericardial fixation system of Example 61, wherein the predetermined distance is at least 10 cm.

[0068] According to another example ("Example 63"), there is provided a method for securing the pericardial fixation system of Example 61, wherein the anchor catheter is configured to move in an inward-outward direction and / or an inferior-superior direction within the pericardial cavity.

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

[0070] According to another example ("Example 65"), a method for securing the pericardial fixation system of Example 61 further includes applying tension to pericardial anchor sutures of the pericardial fixation system to at least partially deform the epicardial anchors to a post-deployment configuration.

[0071] According to another example ("Example 66"), there is provided a method of fixing the pericardial fixation system of Example 61, wherein the epicardial anchor is further deformed to the post-deployment configuration, at least in part, due to a shape memory property of a wire frame of the epicardial anchor that has been shaped to the post-deployment configuration.

[0072] According to another example ("Example 67"), a method of anchoring a pericardial anchoring system includes advancing a support sheath within a cardiac chamber to and against a cardiac wall; advancing a guidewire through the support sheath, advancing a distal end of the guidewire 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; retracting the anchor sheath and the support sheath together while maintaining the position of the guidewire sheath, deploying an epicardial anchor of the pericardial anchoring system within the pericardial space, wherein the epicardial anchor is The method includes retracting the guidewire sheath while maintaining the position of the anchor sheath, which is in a pre-deployment configuration while disposed within the sheath, to form a T-bar between a proximal leg of a wire frame of the epicardial anchor and a distal end 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, retracting the anchor sheath and the support sheath together to deploy the epicardial anchor; and applying tension to pericardial anchor sutures of the pericardial fixation system to at least partially transform the epicardial anchor into a post-deployment configuration.

[0073] According to another example ("Example 68"), there is provided a method of fixing the pericardial fixation system of Example 67, wherein the epicardial anchor is further deformed to the post-deployment configuration, at least in part, due to shape memory properties of the wire frame shaped to the post-deployment configuration.

[0074] According to another example ("Example 69"), a method for securing the pericardial fixation system of Example 67 further includes maintaining the position of the guidewire sheath, retracting the support sheath and the anchor sheath, and deploying a transmyocardial pledget and anchor socket of the pericardial fixation 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 securing the pericardial fixation 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"), a method for securing the pericardial fixation system of Example 67 further includes advancing a suture lock into the anchor socket and advancing the suture lock disposed in the anchor socket toward the endocardium to collapse a second portion of the transmyocardial pledget.

[0077] According to another example ("Example 72"), a method of securing the pericardial fixation system of Example 68, wherein a proximal leg of a film-covered 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, referred to herein as a tool, is provided that is operable to be deployed intramyocardially and to extend into the pericardial cavity from the ventricular side of the heart.

[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 a device coupled to the pericardial cavity, 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-deployment configuration to a high-profile post-deployment configuration, the head defining a channel operable to provide a fluid passage between the heart chamber and the pericardial cavity and defining an eyelet in fluid communication with the lumen to access it, and a base further including a retention member operable to retain the base to the heart wall.

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

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

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

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

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

[0084] According to another example ("Example 79"), the tool of any of Examples 73 to 77, wherein 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, preventing the passage of fluid through the access channel.

[0085] According to another example ("Example 80"), the tool of any of Examples 73 to 77, wherein the head further includes an obstruction element operable to resiliently move 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 to 77 further comprises an occlusion plug positioned within the access channel and operable to occlude the access channel and prevent the passage of fluid through the access channel.

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

[0088] According to another example ("Example 83"), a method of implanting the tool of any one of Examples 69 to 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; and advancing the delivery catheter having the tool coupled thereto into the myocardium, extending a head of the tool into the pericardial cavity.

[0089] According to another example ("Example 84"), there is provided a method of implanting the tool of Example 83, wherein the delivery system further includes a guidewire and / or needle, the method including advancing the 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] According to another example ("Example 85"), a method for mitral valve chordae tendineae repair includes placing a suture lock within an anchor socket; connecting a pericardial anchor suture integral with a pericardial anchor and at least one leaflet anchor suture integral with at least one leaflet anchor to the suture lock; locking the pericardial anchor suture to the suture lock; individually tensioning the at least one leaflet anchor suture to a predetermined tension based on a position of the suture lock for each of the at least one leaflet anchor suture; and locking the at least one leaflet anchor suture.

[0091] According to another example ("Example 86"), a leaflet fixation method includes providing a leaflet fixation system including at least one leaflet anchor configured to pass through a mitral valve leaflet and at least one leaflet suture configured to pierce the mitral valve leaflet and integral with the at least one leaflet anchor; advancing a delivery catheter to a first side of the mitral valve leaflet; advancing a needle through the delivery catheter; extending the needle to puncture the mitral valve leaflet; delivering at least one leaflet anchor integrated with the at least one leaflet suture to a second side of the mitral valve leaflet; individually tensioning the at least one leaflet suture to a predetermined tension based on a position of a suture lock; and withdrawing the delivery catheter.

[0092] According to another example ("Example 87"), the leaflet fixation method of Example 86 further includes locking the at least one leaflet suture with a suture lock to maintain tension on the at least one leaflet suture.

[0093] According to another example ("Example 88"), the leaflet fixation method of Example 86 is provided, wherein the at least one leaflet anchor is a pledget including at least one aperture configured to integrate with the at least one leaflet suture.

[0094] According to another example ("Example 89"), the leaflet fixation method of Example 86 is provided, wherein the at least one leaflet anchor is configured to form a compressed configuration when tension is applied to the at least one leaflet suture.

[0095] According to another example ("Example 90"), the leaflet fixation method of Example 86 further includes compressing the at least one leaflet anchor by applying tension to the at least one leaflet suture.

[0096] The foregoing examples are merely examples and should not be construed as limiting or narrowing the scope of the inventive concepts otherwise provided by this disclosure. [Brief explanation of the drawings]

[0097] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serve to explain the principles of the disclosure.

[0098] [Figure 1A] FIG. 1A is a side view of a fixation system according to one embodiment.

[0099] [Figure 1B] FIG. 1B is a side view of the fixation system of FIG. 1A.

[0100] [Figure 2A] FIG. 2A is a cross-sectional view of the heart.

[0101] [Figure 2B] FIG. 2B is a close-up cross-sectional view of the heart of FIG. 2A.

[0102] [Figure 3] FIG. 3 is a cross-sectional view of a heart with a guidewire according to an embodiment of a method for providing a pericardial fixation system.

[0103] [Figure 4] FIG. 4 is a cross-sectional view of a heart with a guidewire according to an embodiment of a method for providing a pericardial fixation system.

[0104] [Figure 5A] FIG. 5A is a cross-sectional view of a heart with a guidewire according to an embodiment of a method for providing a pericardial fixation system.

[0105] [Figure 5B] FIG. 5B is a cross-sectional view of a heart with a guidewire according to an embodiment of a method for providing a pericardial fixation system.

[0106] [Figure 6] FIG. 6 is a cross-sectional view of a heart with a guidewire and needle catheter according to an embodiment of a method for providing a pericardial fixation system.

[0107] [Figure 7] FIG. 7 is a cross-sectional view of a heart with a guidewire and needle catheter according to an embodiment of a method for providing a pericardial fixation system.

[0108] [Figure 8] FIG. 8 is a cross-sectional view of a heart with a guidewire and catheter according to an embodiment of a method for providing a pericardial fixation system.

[0109] [Figure 9] FIG. 9 is a cross-sectional view of a heart with a catheter and fixation system according to an embodiment of a method for providing a pericardial fixation system.

[0110] [Figure 10]FIG. 10 is a cross-sectional view of a heart with a catheter and a deployed fixation system, according to an embodiment of a method for providing a pericardial fixation system.

[0111] [Figure 11] FIG. 11 is a cross-sectional view of a heart with a deployed fixation system according to an embodiment of a method for providing a pericardial fixation system.

[0112] [Figure 12] FIG. 12 is a cross-sectional view of a heart with a fixation system deployed with a sealing means, according to an embodiment of a method for providing a pericardial fixation system.

[0113] [Figure 13] FIG. 13 is a cross-sectional view of a heart with a fixation system deployed using a tether lock, according to an embodiment of a method for providing a pericardial fixation system.

[0114] [Figure 14] FIG. 14 is a cross-sectional view of a heart with a fixation system deployed and coupled to the mitral valve leaflets to prevent prolapse, according to an embodiment of a method for providing a pericardial fixation system.

[0115] [Figure 15] FIG. 15 is a flow diagram of an embodiment of a method for providing a pericardial fixation system.

[0116] [Figure 16] FIG. 16 is a flow diagram illustrating an embodiment of a method for providing a pericardial fixation system.

[0117] [Figure 17] FIG. 17 is a flow diagram illustrating an embodiment of a method for providing a pericardial fixation system.

[0118] [Figure 18] FIG. 18 is a plan view of a fixation system in a pre-deployment configuration, with the wires and skirt configured in a straight line, according to an embodiment.

[0119] [Figure 19] 19 is a plan view of the anchoring system in a deployed configuration, with the wire and skirt configured in a ring, according to the embodiment of FIG. 18. FIG.

[0120] [Figure 20] FIG. 20 is a perspective cross-sectional view of a fixation system according to the embodiment of FIGS. 18 and 19 deployed within the pericardial space with the anchor positioned against the epicardium and the tether passing through the endocardium, optionally with a tether lock on the opposite side of the endocardium.

[0121] [Figure 21] FIG. 21 is an example of a pericardial fixation system in a deployed configuration, according to an embodiment.

[0122] [Figure 22] FIG. 22 is an example of the pericardial fixation system of FIG. 21 with the pericardial anchor in a deployed configuration and the transmyocardial pledget in a pre-deployed configuration.

[0123] [Figure 23] FIG. 23 is an example of the pericardial fixation system of FIGS. 21 and 22 in a fully deployed configuration.

[0124] [Figure 24] FIG. 24 is a wireframe example of a pericardial anchor in a deployed configuration, according to an embodiment.

[0125] [Figure 25A] FIG. 25A is an example of a pericardial fixation system with a suture lock, according to an embodiment.

[0126] [Figure 25B] FIG. 25B is an example of a pericardial fixation system with a T-bar pericardial anchor, according to an embodiment.

[0127] [Figure 26A]FIG. 26A is an example of a pericardial fixation system with a frameless pericardial anchor, according to an embodiment.

[0128] [Figure 26B] FIG. 26B is an example of a pericardial fixation system with a T-bar and a frameless pericardial anchor, according to an embodiment.

[0129] [Figure 27] FIG. 27 is an example of a pericardial fixation system and a leaflet fixation system deployed and implanted within the heart, according to an embodiment.

[0130] [Figure 28A] FIG. 28A is an example of a leaflet anchor implanted in a valve leaflet and leaflet anchor sutures extending between the leaflet anchor and a pericardial fixation system implanted in the ventricular wall, according to an embodiment.

[0131] [Figure 28B] FIG. 28B is a cross-sectional view of a ventricular wall with an implanted pericardial fixation system, according to an embodiment.

[0132] [Figure 28C] FIG. 28C is an illustration of a pericardial anchor implanted within the pericardial space (pericardium not shown for clarity), according to an embodiment.

[0133] [Figure 29] FIG. 29 is an example of a delivery subsystem for a pericardial fixation system in a first configuration, according to an embodiment.

[0134] [Figure 30] FIG. 30 is an example of a delivery subsystem for the pericardial fixation system of FIG. 29 in a second configuration.

[0135] [Figure 31]FIG. 31 is an example of a guidewire sheath of a delivery subsystem for the pericardial fixation system of FIGS. 29 and 30, according to an embodiment.

[0136] [Figure 32] FIG. 32 is an example of a delivery subsystem with a pericardial fixation system, according to an embodiment.

[0137] [Figure 33] FIG. 33 is a cross-sectional view of a heart with a delivery catheter according to an embodiment of a method for providing a pericardial fixation system.

[0138] [Figure 34] FIG. 34 is a cross-sectional view of a heart with a delivery subsystem for a pericardial fixation system, according to an embodiment of a method for providing the pericardial fixation system.

[0139] [Figure 35] FIG. 35 is a cross-sectional view of a cardiac wall with a support sheath of a delivery subsystem according to an embodiment of a method of providing a pericardial fixation system.

[0140] [Figure 36] FIG. 36 is a cross-sectional view of a heart wall with a guidewire of a delivery subsystem according to an embodiment of a method for providing a pericardial fixation system.

[0141] [Figure 37A] FIG. 37A is a cross-sectional view of a heart wall with an anchor sheath according to an embodiment of a method for providing a pericardial fixation system.

[0142] [Figure 37B] FIG. 37B is a cross-sectional view of a heart with an anchor sheath according to an embodiment of a method for providing a pericardial fixation system.

[0143] [Figure 38]FIG. 38 is a cross-sectional view of the heart wall with the anchor sheath partially retracted to deliver the pericardial fixation system, according to an embodiment of a method for providing the pericardial fixation system.

[0144] [Figure 39] FIG. 39 is a cross-sectional view of the heart wall with the anchor sheath partially retracted to deliver the pericardial fixation system, according to an embodiment of a method for providing the pericardial fixation system.

[0145] [Figure 40] FIG. 40 is a cross-sectional view of the heart wall with a guidewire sheath retracted to deliver a pericardial fixation system according to an embodiment of a method of providing a pericardial fixation system.

[0146] [Figure 41] FIG. 41 is a cross-sectional view of a heart wall with a pericardial fixation system implanted according to an embodiment of a method for providing a pericardial fixation system.

[0147] [Figure 42] FIG. 42 is a cross-sectional view of a heart with a delivery subsystem for a leaflet fixation system, according to an embodiment of a method of providing the leaflet fixation system.

[0148] [Figure 43] FIG. 43 is a cross-sectional view of a heart with a needle according to an embodiment of a method for providing a leaflet fixation system.

[0149] [Figure 44] FIG. 44 is a cross-sectional view of a heart with leaflet anchors according to an embodiment of a method for providing a leaflet fixation system.

[0150] [Figure 45] FIG. 45 is a cross-sectional view of a heart with leaflet anchors according to an embodiment of a method for providing a leaflet fixation system.

[0151] [Figure 46] FIG. 46 is a cross-sectional view of a heart with the delivery subsystem for the leaflet fixation system removed.

[0152] [Figure 47] FIG. 47 is a cross-sectional view of a heart with a delivery subsystem for a suture lock.

[0153] [Figure 48A] FIG. 48A is a cross-sectional view of a heart with a suture lock placed in the anchor socket of a pericardial fixation system.

[0154] [Figure 48B] FIG. 48B is a cross-sectional view of the heart wall with a suture lock placed in the anchor socket of the pericardial fixation system.

[0155] [Figure 49A] FIG. 49A is a cross-sectional view of a heart with anchor sockets of a pericardial fixation system positioned against the heart wall.

[0156] [Figure 49B] FIG. 49B is a cross-sectional view of the heart wall with a pericardial fixation system.

[0157] [Figure 50] FIG. 50 is a cross-sectional view of a heart with a suture cutter.

[0158] [Figure 51] FIG. 51 is a cross-sectional view of the heart with the suture cutters removed.

[0159] [Figure 52] FIG. 52 is a cross-sectional view of the heart with the delivery catheter removed.

[0160] [Figure 53A] FIG. 53A is a cross-sectional view of a heart with multiple leaflet anchors.

[0161] [Figure 53B] FIG. 53B is a cross-sectional view of a heart with multiple leaflet anchor sutures.

[0162] [Figure 54A] FIG. 54A is a side view of a tool according to an embodiment. [Figure 54B] FIG. 54B is a cross-sectional view of a tool according to an embodiment.

[0163] [Figure 54C] FIG. 54C is a cross-sectional view of the left ventricle and mitral valve leaflets showing a steerable guide catheter for tool placement.

[0164] [Figure 54D] FIG. 54D is a cross-sectional view of the left ventricle showing the distal end of the steerable guide catheter.

[0165] [Figure 55A] FIG. 55A is a cross-sectional view of a heart showing a delivery system positioned adjacent to the endocardium, according to an embodiment.

[0166] [Figure 55B] FIG. 55B is a cross-sectional view of a heart showing a tool traversing the endocardium and myocardium with the assistance of a needle for placement in the myocardium and pericardial space during the deployment process, according to an embodiment.

[0167] [Figure 55C] FIG. 55C is a cross-sectional view of the heart showing a tool traversing the epicardium for placement within the myocardium and pericardial space during the deployment process, according to an embodiment.

[0168] [Figure 55D] FIG. 55D is a cross-sectional view of a heart showing a tool enlarging the pericardial space during the deployment process, according to an embodiment.

[0169] [Figure 55E]FIG. 55E is a cross-sectional view of a heart showing the movable elements of a tool that enlarges the pericardial space during the deployment process, according to an embodiment.

[0170] [Figure 55F] FIG. 55F is a cross-sectional view of a heart showing movable elements of a tool engaging the epicardium and / or pericardium to secure the tool within the pericardial space, according to an embodiment.

[0171] [Figure 55G] FIG. 55G is a cross-sectional view of a heart showing movable elements of a tool engaging the epicardium and / or pericardium to secure the tool within the pericardial space, according to an embodiment.

[0172] [Figure 55H] FIG. 55H is a top view of the head showing the arrangement of the movable elements in a deployed configuration, according to an embodiment.

[0173] [Figure 55I] FIG. 55I is a cross-sectional view of a heart showing a tool positioned in a deployed configuration within the myocardium and pericardial space, according to an embodiment.

[0174] [Figure 56A1] FIG. 56A1 is a top view of a tool head with a movable element, according to an embodiment. [Figure 56A2] FIG. 56A2 is a side view of a tool head with a movable element, according to an embodiment.

[0175] [Figure 56A3] FIG. 56A3 is a side view of a tool head with a movable element, according to an embodiment.

[0176] [Figure 56A4] FIG. 56A4 is a side view of a tool head with a movable element, according to an embodiment.

[0177] [Figure 56B1]FIG. 56B1 is a top view of a tool head with a movable element, according to an embodiment.

[0178] [Figure 56B2] FIG. 56B2 is a top view of a tool head with a movable element, according to an embodiment.

[0179] [Figure 56B3] FIG. 56B3 is a top view of a tool head with a movable element, according to an embodiment.

[0180] [Figure 56B4] FIG. 56B4 is a top view of a tool head with a movable element, according to an embodiment.

[0181] [Figure 56C1] FIG. 56C1 is a top view of a tool head with a movable element, according to an embodiment.

[0182] [Figure 56C2] FIG. 56C2 is a top view of a tool head with a movable element, according to an embodiment.

[0183] [Figure 56C3] FIG. 56C3 is a top view of a tool head with a movable element, according to an embodiment.

[0184] [Figure 56C4] FIG. 56C4 is a top view of a tool head with a movable element, according to an embodiment.

[0185] [Figure 56D1] FIG. 56D1 is a side view of a tool head with a movable element, according to an embodiment.

[0186] [Figure 56D2] FIG. 56D2 is a side view of a tool head with a movable element, according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0187] 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 apparatus 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.

[0188] The embodiments described herein are based on various principles and beliefs, but the described embodiments should not be bound by theory. For example, the embodiments described herein are described in the context of preventing mitral valve leaflet prolapse with a fixation system housed within the pericardial cavity. However, embodiments within the scope of the present disclosure are applicable to any prosthetic device or mechanism of similar structure and / or function that requires fixation within a cardiac chamber.

[0189]

[0003] 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 attach to biological elements such as mitral valve leaflets or prosthetic devices such as, but not limited to, sensors or support structures. The anchors, located adjacently within the epicardium (the visceral layer of the serous pericardium), can be any suitable structure, such as, but not limited to, umbrella elements, pledgets, or multi-legged support structures. The anchors have a low profile so that they can pass through narrow access channels in the heart wall and expand or deploy to a larger diameter or surface area within the pericardial space, and are operable to avoid passing through narrow access channels within cardiac structures. The present disclosure relates to mitral valve repair or replacement, and more generally, to methods and devices for mitral valve reconstruction, repair and / or replacement of mitral valve chordae (also called chordae tendineae), to restore normal function of the mitral valve from dysfunctional conditions such as, but not limited to, mitral regurgitation.

[0190] As used herein, the term "heart wall" is defined as the endocardium, myocardium, and epicardium.

[0191] As used herein, the terms "pericardial space" and "pericardial cavity" refer to the space defined by the heart wall and the pericardium, or the space between the visceral and parietal pericardium.

[0192] As used herein, the term "coupled" means joined, connected, attached, adhered, fixed or bonded, whether directly or indirectly, and permanently or temporarily.

[0193] The term "pericardial anchor" is used herein to describe the anchors of a pericardial fixation system, although the anchors of a pericardial system may also be referred to as epicardial anchors or anchors.

[0194] According to an embodiment, as shown in FIG. 17, the pericardial anchor is delivered 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). Crossing of 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 through the epicardium. The guidewire is positioned within the pericardial space, and then the anchor of the fixation system is delivered over the guidewire into the pericardial space.

[0195] The extremely small profile may reduce the risk of adverse events, such as a reduced incidence of pericardial effusion / tamponade.

[0196] Crossing the epicardium with a guidewire instead of a needle catheter may improve safety and ease of the procedure by, for example, eliminating guesswork / ambiguity about reaching the pericardial space too short or too far due to difficulties in imaging and / or understanding placement within the pericardial space. The stiffness of the guidewire may be optimized, for example, at the distal tip and throughout its length, so that the distal tip is sufficiently stiff to pass through the remainder of the heart wall and reach the pericardial space, but soft enough not to deflect and puncture the pericardium (serous pericardium and the parietal layer of fibrous pericardium). The guidewire is coiled within the pericardial space and operable to move within the space. Advancement of the distal end of the guidewire within the space adjacent to the heart wall allows the physician to confirm that the distal end of the guidewire is within the space.

[0197] When the outer diameter of the guidewire is slightly smaller than the inner diameter of the needle, the possibility of coring the heart wall is reduced or minimized, reducing tissue damage. The needle catheter and guidewire can be introduced together, i.e., nested or tandem, with the distal tip of the guidewire pulled back slightly relative to the distal tip of the needle catheter. After the needle catheter punctures the endocardium, the guidewire can be advanced beyond the distal tip of the needle catheter, with the needle catheter supporting the guidewire.

[0198] It will be appreciated that there are various ways to advance the small hollow needle catheter, followed by the nested guidewire, to the target site. 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 a femoral vein access port. 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.

[0199] It is understood that after the guidewire has passed through the pericardial space, several additional steps may need to be performed before the fixation system can be advanced. By way of example, and not limitation, contrast agents, CO2, microcatheters, various guidewires, support / guide catheters, and other devices, drugs, and therapeutic agents may be used for specific purposes. Such devices, drugs, and therapeutic agents may be provided for purposes such as, but not limited to, creating physical space in the pericardial space at the target site, visualizing the pericardial space and / or cardiac / pericardial structures at the target site, and ensuring the insertion of a guidewire of appropriate stiffness and precise diameter into the pericardium for delivery of the fixation system.

[0200] According to embodiments, diagnostic modalities may be employed to provide evidence that the guidewire has traversed the heart wall and entered the pericardial space. By way of example, such diagnostic modalities 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 its proximal and distal ends) or a pressure-sensing guidewire with a sensing element at its distal tip. Data collected from these modalities may provide evidence that the guidewire has traversed the heart wall and entered the pericardial space.

[0201] Pericardial Fixation System 1A and 1B are side views of a fixation 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 in a first position 36 and a larger profile 37 in a second position 38. The fixation system 30 can be used within a heart 2 as shown in FIGS. 2A and 2B. At the first position 36, the anchor 32 is operable to advance from a chamber 6 of the heart 2 through a narrow access channel 12 in the heart wall 41 into the pericardial space 10 and expand within the pericardial space 10 to a second position 38 to a size larger than the narrow access channel 12.

[0202] 2A and 2B are cross-sectional views of the heart 2 and its corresponding anatomical features.

[0203] Guidewire Advancement / Insertion FIGS. 3-14 are a series of illustrations, and FIG. 15 is a flow diagram, of a method for placing an anchor 32 within a heart chamber 6, according to an embodiment. The femoral vein is accessed and a guidewire 40 is advanced therein. 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 adjacent to and through the mitral valve 8 to the heart wall 41 of the left ventricle 22 (FIGS. 5A and 5B). A needle catheter 42 is advanced over the guidewire 40, approximately halfway through the thickness 16 of the myocardium 13 (FIG. 6). The guidewire 40, having a stiff distal tip, is advanced through the needle catheter 42, through the epicardium 14, and into the pericardial space 10 (FIG. 7). The length of the guidewire advanced into the pericardial space 10 can be minimized. The guidewire can be configured to be coiled or assume a coiled shape upon advancement into the pericardial space 10. To maintain the integrity of the heart wall, it may be advantageous to minimize the length of the guidewire inserted into the pericardial space 10. A catheter 44 is advanced over the guidewire 40 into the pericardial space 10 (FIG. 8). A gas, such as carbon dioxide, can be used to inflate the pericardium 18, separating it from the heart wall 41, thereby enlarging the pericardial space 10. The fixation 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, or advanced over the guidewire 40 while the guidewire 40 remains in place within the catheter 44 (FIG. 9). The fixation system 30 can be easily delivered by a fixation system delivery catheter operable to deliver and deploy the fixation system. An anchor 32 is deployed within the pericardial space 10 and positioned against the epicardium 14 (FIG. 10). The anchor 32 can engage the epicardium to secure the fixation system 30 in place. An example of anchor deployment is described with reference to FIG. 16. The fixation system 30 includes a suture or tether 34 coupled to an anchor 32, which is placed within the heart chamber 6 (FIG. 11).

[0204] It is anticipated that once the delivery system, i.e., guidewire 40 and / or catheter 44, is removed from heart 2, the heart wall 41 will seal around the suture or tether 34, eliminating the need for additional material to prevent blood migration from the left ventricle into the pericardial space that may result from the formation of access channel 12. It is anticipated that sealing means 48 may optionally be provided to reduce or eliminate the possibility of blood migration from the left ventricle into the pericardial space. Such sealing means 48 may include, but are not limited to, a surface texture on tether 34 to induce a healing response between tether 34 and heart wall 41, a pledget along tether 34 that can be used to occlude access channel 12, or an expandable portion or element around tether 34 and / or anchor 32 operable to close access channel 12 around tether 34 and / or anchor 32 ( FIG. 12 ).

[0205] In some embodiments, three levels of sealing may occur upon removal of the delivery system from the access channel. The access channel may be sealed to the inside of the heart wall, the outside of the heart wall, and through the access channel into the heart wall. The size of the delivery system may affect the amount or degree of sealing that may be required after removal of the delivery system. In some embodiments, smaller delivery systems may make it easier to achieve three levels of sealing and return the heart wall to its pre-injury state.

[0206] 13, a tether lock 35 is operable to be advanced over the tether 34 and engage the tether 34 against the endocardium 11, capturing and securely holding the heart wall 41 between the tether lock 35 and the anchor. Such a tether lock 35 is operable to securely engage the anchor 32 with the endocardium 11 and can prevent migration of the anchor 32, for example, to prevent subsequent irritation to the pericardium 18.

[0207] As previously mentioned, the sutures or tethers 34 can be used for specific purposes. According to one embodiment, the sutures or tethers 34 are attached to the mitral valve leaflets 9 to prevent prolapse of the leaflets, as shown in FIG.

[0208] In another embodiment, the suture or tether 34 can be attached to a device such as a prosthetic valve.

[0209] In another embodiment, the suture or tether 34 can be coupled to a device such as a sensor.

[0210] Anchor Deployment Overview According to another embodiment, as shown in the flow diagram of FIG. 16 and with reference to FIGS. 1-14 , a fixation method includes advancing a guidewire 40 into the heart 2 adjacent to the heart wall 41. The length of the guidewire advanced into the pericardial space 10 can be minimized. The guidewire can be configured to be coiled or assume a coiled shape as it is advanced into the pericardial space 10. Minimizing the length of the guidewire inserted into the pericardial space 10 can be advantageous for maintaining the integrity of the heart wall. A needle catheter 42 is advanced over the guidewire 40 and advanced 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 and advanced into the pericardial space 10. The pericardium 18 is separated from the heart wall 41, enlarging the pericardial space 10. The fixation system 30 is advanced over the guidewire 40 or through the catheter 44 such that the anchor portion 39 of the fixation system is positioned within the pericardial space 10. The anchor 32 of the fixation system 30 is deployed within the pericardial space 10 and positioned against the epicardium 14. The guidewire 40 and / or catheter 44 are removed from the patient, leaving the tether 34 attached to the anchor 32 within the heart chamber 6.

[0211] According to another embodiment, the fixation method optionally includes advancing a support catheter into the heart, near, up to, adjacent to, or against the heart wall. An anchor catheter is advanced, alone or through an optionally existing support catheter, and positioned near or engaging 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 layer of the serous pericardium) into the pericardial space. An anchor catheter is advanced over the guidewire, through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall, and into the pericardial space. Optionally, the guidewire is withdrawn from the pericardial space. Optionally, the pericardium is separated from the epicardium, and the pericardial space is enlarged. An anchor of the fixation system is advanced or exposed through, at, or near the distal end of the anchor catheter within the pericardial space, where the anchor is positioned within the pericardial space. The anchors of the fixation system are deployed within the pericardial cavity, positioning the anchors 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 cardiac chamber.

[0212] According to another embodiment, a fixation method includes advancing an anchor catheter within a cardiac chamber near or to and against the cardiac wall. A guidewire is advanced through the anchor catheter, with the distal tip of the guidewire passing through the endocardium, into the myocardium, through the epicardium, and into the pericardial cavity. The distal tip of the anchor catheter is advanced along or over the guidewire and advanced into or adjacent to the pericardial cavity. An anchor of the fixation system is advanced or exposed through or at the distal end of the anchor catheter within the pericardial cavity, where the anchor is positioned within the pericardial cavity. The anchor of the fixation system is deployed within the pericardial cavity, positioning the anchor against the epicardium. The guidewire and / or anchor catheter are removed from the patient, leaving a tether coupled to the anchor on the guidewire within the cardiac chamber of the fixation system within the pericardial space.

[0213] Anchor Design According to an embodiment, the fixation system 100 includes an anchor 102. Figure 18 is a plan view of the fixation system 100 in a pre-deployment configuration, where the wire 110 and skirt 120 are in a straight configuration. Figure 19 is a plan view of the fixation system 100 in a post-deployment configuration, where the wire 110 and skirt 120 are in a ring-shaped configuration. Figure 20 is a perspective cross-sectional view of the fixation system 100 deployed within the pericardial space 10, with the anchor 102 positioned against the epicardium 14, the tether 130 passing through the endocardium 11, and optionally a tether lock 140 on the opposite side of the endocardium 11.

[0214] Anchor 102 includes a wire 110 having a wire first end 112 and a wire second end 114. Wire 110 has a shape memory property that allows it to be set into a ring shape with wire first end 112 facing wire second end 114. A skirt 120 is coupled to wire 110 along an edge defining its length. A plurality of apertures 126 are provided along the edge of skirt 120 opposite wire 110. A tether 130 is woven alternately through the plurality of apertures 126, with 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 tighten the skirt 120 into a disk-like shape when the wire 110 is in a ring configuration in a post-deployment configuration, and the first end 132 of the tether and the second end 134 of the tether can be tensioned to straighten the wire 110 into a straight configuration in a pre-deployment configuration.

[0215] Another embodiment of the fixation system 100 is configured such that when in the ring configuration, the first end of the wire 112 and the second end of the wire 114 are operable to fixedly couple to one another.

[0216] In another embodiment, the fixation system 100 is configured such that the first end 112 of the wire and the second end 114 of the wire are operable to engage when in the ring configuration 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.

[0217] Another embodiment of the fixation system 100 is configured such that the skirt 120 has tissue ingrowth properties on one side and tissue anti-adhesion properties on the other side.

[0218] In another embodiment, the fixation system 100 further includes a tether lock 140 slidingly coupled to the tether 130 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.

[0219] Fixing method A fixation method according to one embodiment includes providing a fixation 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 through the mitral valve to the heart wall of the left ventricle adjacent to the heart wall, 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 and 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 and advancing the heart the pericardial cavity from the wall and enlarge the pericardial cavity; advancing the fixation system either over the guidewire or through the catheter to position its anchor within the pericardial cavity; deploying the anchor of the fixation system within the pericardial cavity and positioning the anchor against the epicardium, wherein the anchor is in a straight configuration in a pre-deployment 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 post-deployment 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.

[0220] A fixation method according to one embodiment includes providing a fixation system as described above, advancing a guidewire into the needle catheter so 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 into the myocardium, advancing the distal tip of the guidewire through the myocardium and epicardium into the pericardial cavity, advancing an anchor of the fixation 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-deployment 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 post-deployment configuration due to tension on the first end of the tether and the second end of the tether.

[0221] A method of fixation according to one embodiment includes providing a fixation system as described above; advancing a support catheter into the heart up to, adjacent to, or against the heart wall; advancing an anchor catheter alone or through the support catheter and engaging it against the heart wall; advancing a guidewire along or through the anchor catheter, through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall, and into the pericardial space; advancing the anchor catheter along or over the guidewire, through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall, and into the pericardial space; advancing a pre-fixation system as described above; The method includes advancing or exposing an anchor of the fixation system through or at the distal end of the anchor catheter, wherein the anchor is positioned within the pericardial cavity; deploying the anchor of the fixation system within the pericardial cavity and positioning the anchor against the epicardium, wherein the anchor is in a straight configuration in a pre-deployment 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 post-deployment 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.

[0222] A method of fixation according to one embodiment includes providing a fixation system as described above; advancing an anchor catheter within a cardiac chamber to and against a cardiac wall; advancing a guidewire through the anchor catheter such that a distal tip of the guidewire enters the myocardium through the endocardium and advances through the epicardium into the pericardial space; advancing the distal tip of the anchor catheter along or over the guidewire into or adjacent the pericardial space; advancing or exposing an anchor of the fixation system through or at the distal end of the anchor catheter within the pericardial space; wherein the anchor is positioned within the pericardial cavity; deploying an anchor of the fixation system within the pericardial cavity and positioning the anchor against the epicardium, wherein the anchor is in a straight configuration in a pre-deployment 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 post-deployment 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 on the guidewire and within the pericardial cavity within the heart chamber of the fixation system.

[0223] Loading the pericardial fixation system FIG. 21 is a side view of an example ventricular or pericardial fixation system 200 in a deployed configuration prior to loading into a delivery system. The pericardial fixation system 200 can be configured to be loaded into a delivery system and delivered through a catheter. The pericardial fixation system 200 can include a pericardial anchor 220 and a transmyocardial pledget 240, each in a straight or elongated configuration. The pericardial fixation system 200 can assume the elongated configuration when loaded into and delivered in a catheter having a low profile suitable for advancement through the lumen of the catheter, as shown in FIG. 29. FIG. 22 is an example of a pericardial fixation system 200 with the pericardial anchor 220 in a deployed configuration and the transmyocardial pledget 240 in a pre-deployed configuration. As shown, the pericardial anchor 220 can be in the deployed configuration. The pericardial anchor 220 in the deployed configuration can be compressed, coiled, padded, bunched, curled, curved, etc. 23 is an example of the pericardial fixation system 200 in a deployed configuration. As shown, the pericardial anchor 220 can be in a coiled configuration and the transmyocardial pledget 240 is in a folded configuration. FIG. 23 also shows the leaflet anchor 300 and leaflet anchor suture 310 coupled to the pericardial fixation system 200.

[0224] According to one embodiment, the pericardial fixation system 200 includes a pericardial anchor 220, a transmyocardial pledget 240, an anchor socket 260, and a suture lock 270. In some embodiments, the pericardial fixation system can include any one or any combination of an anchor, a pledget, an anchor socket, and a suture lock. The pericardial anchor 220 can be configured such that at least a portion of the anchor is positioned within the pericardial cavity, thereby making the anchor resistant to being withdrawn through a puncture in the heart wall. At least a portion of the pericardial anchor 220 can be embedded in or contact cardiac tissue, such as the epicardium of the heart wall. The pericardial anchor 220 can be a disk-shaped, ring-shaped, or annular configuration in a deployed configuration. The disk-shaped, ring-shaped, or annular configuration can be planar or non-planar (e.g., helical or curved). Additionally, pericardial anchor 220 can assume a variety of other shapes in the deployed configuration, such as curved, compressed, bundled, massed, or knotted, etc. As further described below, pericardial anchor 220 can include a wire frame or can be wireless.

[0225] Anchor skirt with wire frame The pericardial 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 an embodiment. The wire or wire frame 222 can be made of nitinol, such as platinum-filled nitinol. As shown in FIG. 21 , the skirt 230 or film 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 that act to promote tissue ingrowth. The material of the skirt 230 can have additional properties, such as flexibility and durability to withstand the forces of the beating heart and the deployment process of disc formation. For example, the material of the skirt 230 can be resistant to breakage or tearing during the formation of the disc shape from a straight pre-deployment position to a curved post-deployment position. Additionally, the material of the skirt 230 has material properties, such as strength and light weight, that enable the skirt 230 to have the ability, including but not limited to, to anchor to tissue and stabilize in position after deployment.

[0226] The skirt 230 can include any material suitable for a particular purpose. For example, the skirt 230 material can be suitably flexible or compliant to facilitate deployment of the anchor from a straight configuration to a deployed configuration without fracture and / or unduly restricting deployment. For example, the skirt material can be suitably flexible so as not to overcome or unduly restrict the spring bias of the wire frame to a curved configuration. Furthermore, the skirt material can be suitably flexible to conform to the epicardium after deployment. Furthermore, the skirt material can be suitably durable so as to remain structurally sound over a period of time after deployment, subject to the dynamic motion of the beating heart.

[0227] 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 distal eyelet 224 and the proximal eyelet 226 can be atraumatic ends of the wire frame 222. As shown in FIG. 24 , the distal eyelet 224 can be located at the end of the wire frame, which can make the end of the wire frame atraumatic to tissue that it may contact. For example, the distal eyelet 224 can prevent the end of the wire frame from damaging tissue that it may contact. As further shown in FIG. 24 , the proximal eyelet 226 can be located adjacent to and spaced from the end of the wire frame 222, which can place the end of the wire frame within the area surrounded by the frame 222. In other words, the ends of the wire frame can be contained within or protected by the periphery of the frame 222. Additionally, the proximal eyelets 226 can prevent the ends of the wire frame from damaging tissue with which they may come into contact. The wire frame 222 can have proximal legs or T-bar proximal legs 228 at a proximal portion of the wire frame 222 in the straight configuration. The proximal legs 228 can be located distal to the proximal eyelets 226 of the wire frame 222 in the straight configuration. The proximal legs 228 can be straight portions of the wire frame 222 that remain straight in both the straight configuration and the curved configuration, which in this embodiment is ring-shaped.

[0228] The proximal legs 228 can be reinforced relative to the remainder of the wire frame 222 to resist tension or support forces. According to one embodiment, the proximal legs 228 can include two sections of the same wire folded in half so that they are parallel to each other and can contact each other and be bonded together. In some embodiments, the proximal legs 228 can have stiffer material properties than the remainder of the wire. This advantageously allows the proximal legs 228 to resist bending and remain straight during deployment of the pericardial anchor 220, for example, while abutting the distal end of a delivery catheter, while the remainder of the wire frame 222 can deploy to form a curved configuration. This also advantageously allows for improved actuation and tactile feedback for the operator of the pericardial fixation system 200 as the proximal legs 228 are deployed and retracted. In one embodiment, proximal legs 228 are configured to maintain a straight position and abut pericardial anchor 220 against delivery catheter distal end 502 and the epicardial puncture, retaining pericardial anchor 220 within the pericardial space and preventing proximal legs 228 from passing through the epicardium or from moving back toward delivery catheter distal end 502 after entering the pericardial space. Proximal legs 228 are operable to prevent pericardial anchor 220 from being pulled proximally from the epicardial puncture.

[0229] According to one embodiment, proximal legs 228 are configured to maintain a straight configuration in conjunction with the curved bias of the remainder of wire frame 222 to provide a compressive engagement with a delivery catheter and assist in deployment of pericardial anchor 220. According to another embodiment, proximal legs 228 are configured to maintain a straight configuration in conjunction with the curved bias of the remainder of wire frame 222 to provide a profile operable to prevent the anchor from passing through an epicardial puncture after deployment.

[0230] The skirt 230 can be coupled to the wire frame 222 along an edge defining its length. The wire frame 222 can be disposed at one end or edge of the skirt 230. In one embodiment, a tether or pericardial anchor suture 280 is coupled to the opposite edge of the skirt 230. According to another embodiment, a plurality of anchor apertures 232 are disposed along the edge of the skirt 230 opposite the wire frame 222. The tether or pericardial anchor suture 280 is woven alternately through and slidingly received by the plurality of anchor apertures 232. A first end of the pericardial anchor suture 280 is configured to be fixedly coupled to the first end of the skirt 230 at a suture connection 234. According to an embodiment, the suture connection 234 can be a reinforced portion of the skirt 230, reinforced with additional or secondary material to facilitate and strengthen the coupling. In other embodiments, the reinforcement portion may have different material properties, such as, but not limited to, pressure and / or heat densification, such as a porous material. Suture connection 234 may be provided at a distal end or portion of skirt 230, which advantageously improves deployment of pericardial anchor 220 and also improves tension retention of pericardial anchor suture 280. According to one embodiment, suture connection 234 at a distal end or portion of skirt 230, cooperating with anchor aperture 232 of skirt 230, distributes a predetermined amount of force along skirt 230 compared to a more concentrated load at a connection point located more proximally on skirt 230.

[0231] The entire wire frame 222 can be coupled to the skirt 230. In one embodiment, the skirt 230 covers the entire wire frame 222, for example, by being disposed within a fold or hem of the film or embedded within a layer of the film, thereby improving the stability of the pericardial anchor 220 in the event of breakage or damage to the wire frame 222. The skirt 230 covering the wire frame 222 can further prevent the pericardial anchor sutures 280 from being misrouted or entangled in the wire frame 222, particularly during transition of the pericardial anchor 220 from a pre-deployment configuration (e.g., an elongated configuration) to a post-deployment configuration (e.g., a curved configuration).

[0232] In other embodiments, instead of weaving the pericardial anchor sutures 280 through the plurality of anchor apertures 232, the pericardial anchor sutures 280 can be incorporated into the skirt 230 in other ways, such as being integrated into the skirt 230 itself or being fixedly attached to or slidingly received in a portion of the skirt 230. In some examples, the skirt 230 can include a tunnel or channel that slidingly receives the pericardial anchor sutures 280.

[0233] In other embodiments, a biasing element can be integrated into or incorporated into skirt 230 instead of wire frame 222. The biasing element is operable to bias skirt 230 into a curved configuration. According to one embodiment, the biasing element is a densified, embossed, or treated portion of skirt 230 and is operable to bias pericardial anchor 220 to transform from a pre-deployment configuration to a post-deployment configuration, for example, from an elongated configuration to a curved configuration.

[0234] 21 , tension can be applied to distal suture ends 315 of pericardial anchor sutures 280 extending through skirt 230 and / or proximal suture ends 317 of pericardial anchor sutures 280 to maintain pericardial anchor 220 in a straight configuration against the bias of wire frame 222 in the pre-deployment configuration. Pericardial anchor sutures 280 can be operable to be tensioned to tighten skirt 230 into a curved, disk-like, or annular shape when wire frame 222 is in the post-deployment configuration. Pericardial anchor sutures 280 can be operable to tighten skirt 230 such that skirt 230 extends across the curved portion of wire frame 222 and completely covers the central portion defined by wire frame 222.

[0235] Regardless of whether the skirt 230 has a biasing member such as the wire frame 222, the deployed configuration can be a T-bar, coil, pad, bundle, ring, annular, knot, etc., among others. The deployed configuration can be operable to provide one or more functions, such as, but not limited to, preventing pull-out through a puncture in 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.

[0236] In some examples, the proximal suture end 317 of the pericardial anchor suture 280 is tensioned, such as in a proximal direction, to tighten the skirt 230 into a post-deployment configuration (e.g., compressed, coiled, curved, curled, ringed, annular, knotted, bundled, or padded) when the pericardial anchor 220 is in the post-deployment configuration. The biasing force of the biasing member is biased to pull the skirt into the curved configuration. The tension on the pericardial anchor suture 280 can assist the biasing member in bending and / or help secure the complete post-deployment configuration (e.g., the curved or ring configuration). The pericardial anchor suture 280 can be connected to the skirt 230 in a configuration that minimizes bunching or tangling of material. The pericardial anchor suture 280 can curl the skirt 230 from a proximal to a distal direction to minimize bunching of material. In some embodiments, the skirt 230 can compress or accordion-like fold the material of the skirt 230. The skirt 230 can incorporate pleats to facilitate curling during deployment of the skirt 230. This allows the skirt 230 to form a desired configuration that seals against the heart wall with a low profile.

[0237] The distribution of the applied tension can vary depending on the post-deployment configuration of the skirt 230. For example, a curved or curled post-deployment configuration of the skirt 230 can include a centroidal distribution of tension, while a T-bar-shaped post-deployment configuration of the skirt 230 can distribute tension along the circumference of the skirt 230. The distribution of tension can affect the resulting force that the pericardial anchor 220 applies to the heart wall to seal tissue after deployment. The pericardial anchor 220 can transition from a pre-deployment configuration (e.g., an elongated configuration) as shown in FIG. 21 to a post-deployment configuration (e.g., a coiled configuration) as shown in FIGS. 22 and 23. This transition can be facilitated, at least in part, by tensioning the pericardial anchor suture 280, by the biasing of a biasing element such as the wire frame 222, or both.

[0238] 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 , which creates a spring bias to the curved configuration when extended to a straight configuration, such as when it is in the pre-deployment configuration provided with the delivery system. When the pericardial anchor 220 is in the post-deployment configuration, as shown in FIG. 24 , the T-bar or proximal leg 228 remains straight, and the remainder of the wire frame 222 is biased to conform to the post-deployment curved, i.e., unconstrained, configuration. In the curved configuration, the T-bar proximal leg 228 can be positioned at the center of the pericardial anchor 220 in the post-deployment configuration. The T-bar proximal leg 228 can be positioned to overlap the center of the curve defined by the pericardial anchor 220, thereby extending across the diameter of the pericardial anchor 220 when in the ring configuration, according to one embodiment. The wire frame 222 can 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 the pericardial anchor 220's periphery in the deployed state. The distal eyelet 224 can be positioned to overlap the pericardial anchor 220's periphery 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 cuff 229 and can overlap or be adjacent to the pericardial anchor 220's periphery in the deployed configuration. The distal eyelet 224 and the proximal eyelet 226 provide an atraumatic end for the wire frame 222, preventing damage to the delivery system and / or adjacent tissue, such as during deployment of the pericardial anchor 220 or after the pericardial anchor 220 is implanted within the pericardial space. In other examples, the pericardial anchor 220 can have another type of atraumatic end, such as a rounded end or a blunt end, instead of an eyelet. The atraumatic end can advantageously prevent damage to tissue or other parts of the fixation system, such as the skirt 230, during the implant procedure.

[0239] In some configurations, the wire frame 222 can be biased to form a helix when in a curved configuration in the deployed configuration. This helical bias can advantageously prevent the wire frame 222 from entangling with itself, other components of the fixation system, or the area of ​​the implant procedure. The helical configuration can assist the pericardial anchor 220 in transforming into a coiled configuration. In some configurations, the wire frame 222 has a bias such that the pericardial anchor 220 defines a substantially planar disk when in the deployed configuration.

[0240] In other embodiments, instead of the coiled configuration shown in FIGS. 22 and 23 , the pericardial anchor 220 can transition from a pre-deployment configuration (e.g., an elongated configuration) suitable for pre-deployment, such as within a catheter, to a post-deployment configuration (e.g., a T-shape, ring-like, coiled, curved, compressed, bundled, or padded configuration) in various ways. For example, the pericardial anchor 220 can be curved or coiled beginning or starting from a free end of the pericardial anchor 220 to form a post-deployment shape, such as a disk shape. This free end is the distal end of the pericardial anchor 220 and can be the distal end of both the pericardial anchor 220 and the pericardial fixation system 200. The coiled deformation can be partial, forming a partial disk shape, complete, forming a complete disk shape, overlapping to form a complete disk shape, or the like. The disk-like shape can be low-profile so as not to significantly abut or otherwise interfere with the parietal pericardium. The size of the disk-shaped shape can be configured to prevent the pericardial anchor 220 from being pulled out from the delivery subsystem 400 or the pericardial anchor suture 280 through a puncture or channel in the myocardium and through the heart wall. The size of the disk-shaped shape can be configured to atraumatically distribute forces caused by tension on the remainder of the pericardial fixation system 200 to the pericardial anchor 220 and the surrounding tissue it abuts. T-bar-shaped pericardial anchors, described further below, can have a low profile to allow linear deployment of the T-bar. The bar can be configured to prevent the pericardial anchor 220 from being pulled out from the delivery subsystem 400 or the pericardial anchor suture 280 through a puncture or channel in the myocardium and through the heart wall. In some embodiments, the coiled deformation can form a shape with a larger width or diameter than the pre-deployment configuration. According to other embodiments, the shape of the anchor can define other shapes, such as, but not limited to, a square, a cross, and a diamond. The wire frame 222 of the pericardial anchor 220 is operable to straighten and return to a low profile, high surface area shape, which is advantageous for delivery and deployment of the pericardial anchor 220.In the deployed state, the pericardial anchor 220 defines a surface area within the curved shape formed by the pericardial anchor 220 that is operable to, without limitation, promote tissue ingrowth and / or distribute the load on the pericardial fixation system 200 over a larger area of ​​the cardiac surface.

[0241] In some embodiments, the pericardial anchor 220 can be bunched or packed to achieve the deployed configuration. For example, the pericardial anchor 220 in its elongated configuration can be folded, compressed, bunched, curled, or packed to form the deployed configuration.

[0242] Presidio As described above, the pericardial fixation system 200 can also include a pericardial anchor suture 280. The pericardial anchor suture 280 can extend through each of the pericardial anchor 220 and the transmyocardial pledget 240. The pericardial anchor suture 280 can be coupled to the skirt 230 of the pericardial anchor 220, for example, but not by way of limitation, by being woven into or integral with the skirt 230. As shown in FIG. 21 , the pericardial anchor suture 280 can be woven through the skirt 230 and through multiple anchor apertures 232. The pericardial anchor suture 280 can extend from the skirt 230 of the pericardial anchor 220 and then be woven through the transmyocardial pledget 240. The transmyocardial pledget 240 also includes multiple pledget apertures 262, and the pericardial anchor suture 280 can 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.

[0243] The pericardial fixation system 200 can include pledgets as disclosed in International Application No. PCT / US2020 / 032054 or International Application No. PCT / US2020 / 032168 (incorporated herein by reference in their entireties), and various embodiments of the pledgets disclosed therein. The transmyocardial pledget 240 can be tubular, spherical, rectangular, etc. The transmyocardial pledget 240 can be used to increase, adjust, add, enlarge, and / or expand the surface area of ​​the sutures. The transmyocardial pledget 240 can include a film. The film can be a fluoropolymer that can have tissue ingrowth properties. The film of the transmyocardial pledget 240 can have a tubular structure. The transmyocardial pledget 240 can include multiple pledget apertures 262 disposed along the length of the transmyocardial pledget 240. Pericardial anchor sutures 280 can be woven or integrated through the film of the transmyocardial pledget 240. As shown in FIGS. 21 and 22 , pericardial anchor sutures 280 can be woven through multiple pledget apertures 262 that penetrate the film of the transmyocardial pledget 240. The pericardial anchor sutures 280 can convert the transmyocardial pledget 240 from a straight configuration, as shown in FIG. 21 , to a curved configuration, as shown in FIG. 23 . For example, tensioning or retracting the pericardial anchor sutures 280 can cause the material of the transmyocardial pledget 240 to compress or fold in an accordion-like manner. In some instances, continued tension on the pericardial anchor sutures 280 can continue to cause the material of the transmyocardial pledget 240 to compress or fold in an accordion-like manner. The transmyocardial pledget 240 can include pleats to facilitate folding during deployment of the transmyocardial pledget 240.

[0244] As shown in FIG. 21 , the pericardial anchor 220 is positioned at the distal end of the pericardial fixation system 200, and the transmyocardial pledget 240 is positioned proximal to the pericardial anchor 220. The transmyocardial pledget 240 can extend from the proximal leg 228 of the pericardial anchor 220. The transmyocardial pledget 240 can be directly laminated to or otherwise coupled to the proximal leg 228 of the wire frame 222 of the pericardial anchor 220. This advantageously allows the transmyocardial pledget 240 to be positioned through the epicardial and myocardial puncture while the proximal leg 228 is positioned across the epicardial puncture. The transmyocardial pledget 240 is operable to seal the puncture in the heart wall. In some configurations, as shown in FIG. 21 , in a pre-deployed configuration, the pericardial anchor 220 and the transmyocardial pledget 240 can extend at an angle to each other. Also, in some configurations, the pericardial anchor 220 and the transmyocardial pledget 240 can extend linearly relative to one another.

[0245] The transmyocardial pledget 240 is configured to extend from the pericardial anchor 220 through the epicardium, myocardium, and endocardial punctures (also referred to as heart wall channels 5), as shown in FIG. 36 . The transmyocardial pledget 240 can fill and seal the heart wall channels 5 defined in the epicardium, myocardium, and endocardium by traversing the heart wall to access the pericardial cavity with a delivery system. The transmyocardial pledget 240 is configured to expand within the myocardial puncture to seal the myocardial puncture. The portion of the transmyocardial pledget 240 disposed through the myocardial heart wall channel 5 can extend linearly, while the material of the transmyocardial pledget 240 disposed adjacent to the endocardium can collapse or fold to seal the heart wall channel 5 at the endocardium. This advantageously allows the transmyocardial pledget 240 to accommodate various myocardial thicknesses by collapsing into the endocardium and / or expanding to a diameter sufficient to prevent leakage through the heart wall channel 5.

[0246] Suture lock The pericardial fixation system 200 can further include an anchor socket 260 capable of holding a suture lock 270. The pericardial fixation system 200 can include a suture lock such as that disclosed in U.S. Patent No. 9,877,833. The pericardial fixation system 200 can include suture locks and sockets as disclosed in International Application No. PCT / US2021 / 035423 or U.S. Application No. 16,711,321 (incorporated herein by reference in its entirety), as well as various embodiments of the suture locks or sockets disclosed therein. The pericardial fixation system 200 can include sockets as disclosed in U.S. Application No. 16 / 710,637 (incorporated herein by reference in its entirety), as well as various embodiments of the suture locks or sockets disclosed therein. The suture lock 270 can be used to secure the pericardial anchor sutures 280 and the leaflet anchor sutures 310, respectively. Suture lock 270 can also be used to apply tension and adjust the length of each of pericardial anchor suture 280 and leaflet anchor suture 310. Once the lengths have been optimized to provide the proper tension for the mitral valve repair, suture lock 270 can be locked to fix the lengths of each of pericardial anchor suture 280 and leaflet anchor suture 310.

[0247] socket As used herein, the term "socket" encompasses and may be used interchangeably with terms such as cover, receptacle, shroud, coupler, constraint, and retaining member. According to one embodiment, the anchor socket 260 can have a tubular structure that can receive and at least partially cover the suture lock 270. The anchor socket 260 can include a self-expanding frame that can minimize the profile of the anchor socket 260 when in a pre-deployed configuration on a delivery system. The self-expanding frame can be a nitinol stent frame. The self-expanding frame can 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. In some embodiments, the anchor socket 260 can include a film-covered self-expanding frame that can expand to enlarge the anchor socket 260 when released from a pre-deployment position. The anchor socket 260 can have a tapered distal end operable to engage endocardial folds and undulations rather than a distal end that is larger and / or less likely to interfere with endocardial engagement. This can improve stability of the anchor socket 260 through the dynamic movement of the beating heart. The anchor socket 260 can further include a gold marker band around the anchor socket 260 to provide visual guidance. The self-expanding frame can 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, ensuring that the anchor socket 260 completely covers the suture lock 270. The anchor socket 260 can provide a retaining member that limits movement of the suture lock relative to the rest of the pericardial fixation system 200 and movement of the suture relative to the suture lock 270 .Anchor socket 260 may also be referred to as a suture lock guide, socket, or sleeve. Anchor socket 260 can reduce wear and secure tension on pericardial anchor suture 280 and leaflet anchor suture 310. Anchor socket 260 can couple pericardial fixation system 200 and a suture lock.

[0248] 21-23, anchor socket 260 and suture lock 270 can extend or be positioned proximally from transmyocardial pledget 240. This location of anchor socket 260 advantageously facilitates folding or collapsing transmyocardial pledget 240 between the endocardial surface and anchor socket 260.

[0249] 22, the transmyocardial pledget 240 may also include a catheter access hole 242 at the proximal end of the transmyocardial pledget 240 adjacent the anchor socket 260. 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 the socket lumen 264 of the anchor socket 260, as shown in FIG. 22, and extend along the transmyocardial pledget 240 and pericardial anchor 220, as shown in FIG.

[0250] 25A is an example of a ventricular fixation system with a separate socket. The anchor socket 260 can be separate from the rest of the pericardial fixation system 200. The anchor socket 260 can be positioned proximal to the transmyocardial pledget 240 and connected to the transmyocardial pledget 240, but can be separate in that the anchor socket 260 is configured to move relative to the transmyocardial pledget 240.

[0251] T-bar anchor Instead of a pericardial disk anchor, various types of ventricular or pericardial anchors can have various shapes other than a disk or ring shape. The ventricular or pericardial anchor can be a drawstring anchor, which allows the anchor to be converted from a pre-deployed configuration to a post-deployed configuration by tensioning or retracting a suture. The pre-deployed configuration can be an elongated configuration. The post-deployed configuration can have various shapes, such as a disk, ring, curved, compressed, bundled, padded, or knotted configuration, as described above. FIG. 25B shows an example of a pericardial fixation system with a T-bar pericardial anchor. The ventricular fixation system of FIG. 25B can be similar to the pericardial fixation system 200 described above. However, instead of the wire frame 222 and skirt 230 of the pericardial anchor 220, the ventricular fixation system of FIG. 25B can include a T-bar pericardial anchor. The T-bar 290 can be covered with a film. The T-bar 290 can function similarly to the T-bar proximal leg 228 of the pericardial anchor 220. The T-bar 290 can be positioned against the myocardial puncture within the epicardial space. This placement can help not only seal the puncture but also prevent the pericardial anchor from deploying non-planarly and spreading under the T-bar itself. For example, the placement of the T-bar can create a surface for the pericardial anchor to deploy. The film-covered T-bar 290 can be integral with the transmyocardial pledget 240 or separate.

[0252] FIG. 26A is an example of a pericardial fixation system with a frameless pericardial anchor. The ventricular fixation system of FIG. 25B can be similar to the pericardial fixation system 200 described above. However, instead of the wire frame 222 and skirt 230 of the pericardial anchor 220, the ventricular fixation 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 pericardial anchor 220. The pericardial anchor sutures 280 can be integrated into or woven into the wireless skirt 230. Tensioning the pericardial anchor sutures 280 can tighten the wireless skirt 230 into a disk, ring, or bundled wad configuration in the deployed configuration, as shown in FIG. 26A.

[0253] FIG. 26B illustrates an example of a pericardial fixation system including a T-bar and a frameless pericardial anchor. The ventricular fixation system of FIG. 25B can be similar to the pericardial fixation system 200 described above. However, instead of the wire frame 222 and skirt 230 of the pericardial anchor 220, the pericardial fixation system of FIG. 25B can include a film-covered T-bar proximal leg 228, referred to as a 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 pericardial anchor 220. The T-bar 290 can be positioned against a myocardial puncture in the epicardial space. The film- or skirt-covered T-bar 290 can be integrated with or separate from the transmyocardial pledget 240. The wireless skirt 230 can function similarly to the skirt 230 of the pericardial anchor 220. The pericardial anchor sutures 280 can be integrated into or woven into the wireless skirt 230. The pericardial anchor sutures 280 can be tensioned to tighten the wireless skirt 230 into a ring configuration in the deployed configuration, as shown in FIG. 26A.

[0254] The wireless skirt 230 can function similarly to the skirt 230 of the pericardial anchor 220. The pericardial anchor sutures 280 can be integrated into or woven into the wireless skirt 230. The pericardial anchor sutures 280 can be tensioned to tighten the wireless skirt 230 into a disk-like, ring-like, curved, or bundled wad configuration in the deployed configuration, as shown in FIG.

[0255] Deployed fastening system FIG. 27 illustrates an example of a pericardial fixation system 200 deployed and partially implanted in a cardiac ventricle. As shown, a ring-configured pericardial anchor 220 is positioned within the pericardial cavity. The pericardial anchor 220 can secure the pericardial fixation system 200 and can serve as a mechanical interface for securing the pericardial fixation system 200. The pericardial anchor 220 can also function to seal one end of the myocardial puncture. A transmyocardial pledget 240 extends from the pericardial 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 rest against the folded portion of the transmyocardial pledget 240. The suture lock 270 enclosed within the anchor socket 260 can press the anchor socket 260 against the endocardial surface, which can facilitate sealing the puncture at the endocardial surface with the folded portion of the transmyocardial pledget 240. The pericardial anchor suture 280 can extend through the pericardial anchor 220, through the transmyocardial pledget 240, and into the suture lock 270. The pericardial anchor suture 280 can also function as a tensioning member for forming the pericardial 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 damage caused by the pericardial anchor suture 280. The transmyocardial pledget 240 increases the volume of the pericardial anchor suture 280, which, by itself, can tend to cut or slice the myocardium upon application of tension or load. The transmyocardial pledget 240 prevents the pericardial anchor suture 280 from migrating within the myocardium. The transmyocardial pledget 240 can form a myocardial seal by blocking a channel or puncture through the heart wall 41 and by 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 leaflet anchor 300 implanted in the leaflet 9 and the suture lock 270 to repair the mitral valve chordae tendineae.

[0256] Implanted leaflet anchor FIG. 28A illustrates an example of a leaflet anchor implanted in a valve leaflet and leaflet anchor sutures 310 extending between the leaflet anchor 300 and a pericardial fixation system 200 implanted in at least the ventricular wall. As shown, the pericardial fixation system 200 is implanted in the ventricular wall, with the anchor socket 260 positioned against the endocardial surface of the heart wall 41. The leaflet anchor 300 can be an anchor configured so that at least a portion of the anchor is positioned within or on the leaflet. At least a portion of the pericardial anchor 220 can be embedded in or contact the tissue of the leaflet. The leaflet anchor 300 can have 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 to the leaflet anchor 300. The leaflet anchor 300 can be an anchor positioned within a mitral valve leaflet 9. The leaflet anchor 300 can be a pledget.

[0257] 28B is a cross-sectional view of a ventricular wall in which a ventricular fixation system has been implanted. As shown, a pericardial anchor 220 can be positioned within the pericardial cavity 10. A transmyocardial pledget 240 can extend from the pericardial anchor 220 and extend through the endocardial, myocardial, and epicardial punctures. The transmyocardial pledget 240 can also be folded against the endocardial surface of the heart wall 41. An anchor socket 260 can be positioned against the endocardium of the heart wall 41.

[0258] FIG. 28C is a diagram of pericardial anchor 220 implanted within the pericardial space.

[0259] Sheath Delivery Subsystem Figure 29 shows a first example configuration of a delivery system or delivery subsystem 400. Figure 30 shows a second example configuration of the delivery subsystem 400 of Figure 29. Figure 31 shows an example guidewire sheath for the delivery subsystem 400 of Figures 29 and 30.

[0260] The delivery subsystem 400 can be delivered through a delivery catheter. The delivery subsystem 400 can include three catheters or sheaths, including a support sheath 460, an anchor sheath 440, and a guidewire sheath 420. The delivery subsystem can further include a guidewire 410 configured to be delivered through the guidewire sheath 420. The sheaths 420, 440, and 460 can be configured to fit together or nest within one another. The support sheath 460 can be an outer sheath that receives the anchor sheath 440. The anchor sheath 440 can be an intermediate sheath that is received in the support sheath 460 and receives the guidewire sheath 420. The guidewire sheath 420 can be received in the anchor sheath 440 and receives the guidewire 410. FIG. 29 shows the guidewire sheath 420 withdrawn distally from the anchor sheath 440 more than shown in FIG. 30. The guidewire 410 can be positioned within the inner circumference of the guidewire sheath 420, allowing the guidewire 410 to be delivered through the guidewire sheath 420. The pericardial fixation system 200 can be positioned between the outer circumference of the guidewire sheath 420 and the inner circumference of the anchor sheath 440, allowing the pericardial fixation system 200 to be delivered by retracting the anchor sheath 440.

[0261] FIG. 32 illustrates an example of a guidewire sheath 420 equipped with a pericardial fixation system 200. The anchor sheath 440 is retracted. As shown in FIG. 32, the pericardial fixation system 200 can be disposed on the outer surface of the guidewire sheath 420. The guidewire sheath 420 can include multiple sleeves 424 on the outer surface of the guidewire sheath 420 and between the various portions of the pericardial fixation system 200 to constrain the various portions of the pericardial fixation system 200. For example, the sleeves 424 can be disposed on either side of the anchor socket 260 of the pericardial fixation system 200. The sleeves 424 can assist in the advancement or positioning of various portions of the ventricular fixation system. For example, the sleeves 424 can be disposed proximal to the pericardial anchor 220 to advance the pericardial anchor 220 as the guidewire sheath 420 is advanced. For example, the sleeves 424 can be disposed proximal to the pericardial anchor 220 to position the proximal T-bar leg 228 of the pericardial anchor 220 during the implantation procedure. The sleeve 424 can be made of plastic. The guidewire sheath 420 can further include fluoroscopic markers. An anchor sheath 440 can be placed over the pericardial fixation system 200 to restrain the pericardial fixation system 200 until it is ready to be deployed. The anchor sheath distal end 442 of the anchor sheath 440 can be used to engage the T-bar after deployment, thereby providing abutment or leverage against the wire frame 222 when tightening the pericardial anchor sutures 280.

[0262] The support sheath 460 can provide control for guiding the delivery subsystem 400 to a target site, such as the left ventricle or the ventricular wall of the left ventricle. The support sheath 460 can provide support while the pericardial fixation system is advanced through the ventricular wall, such as by advancing the guidewire 410 or the anchor sheath 440. The support sheath 460 can have at least a malleable distal portion. The distal portion of the anchor sheath 440 is operable to advance through the cardiac wall 41, including the endocardium, myocardium, and epicardium of the cardiac wall 41. The anchor sheath 440 can have at least a proximal portion that is more rigid than the malleable distal portion, thereby providing increased control during delivery. The anchor sheath 440 can include a radiopaque marker at the distal or tip of the anchor sheath 440.

[0263] 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 can be tapered to allow for smooth withdrawal of the dilator tip 422 and to minimize trauma as it is withdrawn through the heart wall 41.

[0264] 33-41 are a series of diagrams illustrating a method of providing a pericardial fixation system 200, according to one embodiment.

[0265] 33 is a cross-sectional view of a heart with a delivery catheter 500 according to an embodiment of a method for providing a pericardial fixation system 200. The delivery catheter 500 can be positioned in the left atrium. The delivery catheter 500 can be delivered via a transfemoral, transseptal approach.

[0266] FIG. 34 is a cross-sectional view of a heart with a delivery subsystem 400 for the pericardial fixation system 200, according to an embodiment of a method for providing the pericardial fixation system 200. The delivery subsystem 400 for the pericardial fixation system 200 can be delivered through a delivery catheter 500. The delivery subsystem 400 can then be advanced to a target location, such as through the mitral valve and 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 for the delivery subsystem 400, according to an embodiment of a method for providing the pericardial fixation system 200. The support sheath 460 for the delivery subsystem 400 for the pericardial fixation system 200 can be advanced to the heart wall 41 of the left ventricle, as shown in FIGS. 34 and 35.

[0267] 36 is a cross-sectional view of a cardiac wall 41 with a guidewire 410 of a delivery subsystem 400, according to an embodiment of a method of providing a pericardial fixation system 200. The guidewire 410 of the delivery subsystem 400 can be advanced distally from the distal end of the support sheath 460. The guidewire 410 can puncture the cardiac wall 41, including the endocardium, myocardium, and epicardium, and be advanced through the cardiac wall 41 and directed into the pericardial space 10. The guidewire 410 is positioned within the pericardial space 10 so that anchors can be delivered over the guidewire 410 into the pericardial space 10. The stiffness of the guidewire can be optimized at its distal tip and along its entire length, including, but not limited to, being sufficiently stiff to allow at least the distal tip to traverse the cardiac wall 41 and enter the pericardial space 10, yet being sufficiently flexible to flex into the pericardial space 10 and not puncture the pericardium (serous and fibrous wall layers). The guidewire 410 is operable to pivot and advance within the pericardial space 10. The distal end of the guidewire 410 advances within the pericardial space 10 adjacent the heart wall 41, thereby demonstrating to the clinician that the distal end of the guidewire 410 is within the pericardial space 10. As the guidewire 410 flexes within the pericardial space 10, the guidewire 410 advantageously pops out across the epicardium, after which tactile feedback can be provided as the guidewire 410 moves freely within the pericardial space 10.

[0268] 37A is a cross-sectional view of a cardiac wall 41 with an anchor sheath 440 according to an embodiment of a method of providing a pericardial fixation system 200. The anchor sheath 440 and a guidewire sheath 420 with a dilator tip 422 can be advanced distally together from a support sheath 460 over a guidewire 410, through the cardiac wall 41, including the endocardium, myocardium, and epicardium, and into the pericardial space 10.

[0269] FIG. 37B is a cross-sectional view of a heart with an anchor sheath 440 according to an embodiment of a method for providing a pericardial fixation 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 unsheath the pericardial anchor in the 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 guidewire sheath 420 can be advanced in a medial / lateral direction, an inferior / superior direction, or a combination thereof, which advantageously allows the anchor sheath 440 and guidewire sheath 420 to move tangentially within the pericardial space 10 without requiring extensive or additional dilation or elongation of the pericardial space itself. The anchor sheath 440 and guidewire sheath 420 are extended to a sufficient length to allow the pericardial anchor 220 to be unsheathed in the elongated configuration.

[0270] 38 is a cross-sectional view of the heart wall 41 with the anchor sheath 440 partially retracted to deliver the pericardial anchor 220 of the pericardial fixation system 200, according to an embodiment of a method for providing the pericardial fixation system 200. With the guidewire sheath 420 held in place, the support sheath 460 and the anchor sheath 440 can be retracted together to expose the pericardial fixation system 200 disposed between the anchor sheath 440 and the guidewire sheath 420. In some instances, the anchor sheath 440 can be retracted until the marker band on the anchor sheath 440 reaches the marker band on the guidewire sheath 420, thereby unsheathing the pericardial fixation system 200. The anchor distal end 225 of the pericardial anchor 220 is unsheathed first, and begins to transition (e.g., curve or coil) once the pericardial anchor 220 is no longer constrained by the anchor sheath 440 due to the biasing or shape-memory properties of the biasing element. Once the pericardial anchor 220 is fully exposed and unsheathed, the proximal leg 228 of the pericardial anchor 220 can abut against the tip of the anchor sheath 440 and the heart wall 41 as the anchor sheath 440 is retracted.

[0271] 38 is a cross-sectional view of the heart wall 41 during delivery of the pericardial fixation system 200 with the anchor sheath 440 partially retracted, according to an embodiment of a method for providing the pericardial fixation system 200. Next, while maintaining the position of the anchor sheath 440, the guidewire sheath 420 can be retracted to form a T-bar between the proximal leg 228 of the pericardial anchor 220 and the tip of the anchor sheath 440. All sheaths, i.e., 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 pericardial anchor 220 can then be positioned between the epicardium and the guidewire sheath 420. This prevents the pericardial anchor 220 from being retracted into the epicardial puncture and maintains the position of the pericardial anchor 220 within the pericardial space.

[0272] Pericardial Anchor Deployment / Delivery 39 is a cross-sectional view of the heart wall 41 with the anchor sheath 440 partially retracted to deliver the pericardial fixation system 200, according to an embodiment of a method for providing the pericardial fixation 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 positioned through the myocardium into the puncture as the anchor sheath 440 and support sheath 460. Once the myocardial puncture is filled, the remaining portion 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 pledge 240.

[0273] FIG. 40 is a cross-sectional view of the heart wall during retraction of the guidewire sheath 420 to deliver the pericardial fixation system 200, according to an embodiment of a method for providing the pericardial fixation system 200. The guidewire sheath 420 and guidewire 410 can be retracted to deploy the pericardial fixation system 200. The guidewire sheath 420, anchor sheath 440, and support sheath 460 can then all be withdrawn to fully expose the pericardial fixation system 200. Once the pericardial fixation system 200 is fully deployed, tension can be applied to the pericardial anchor sutures 280, allowing the pericardial anchor 220 to fully coil or curl. Additionally, tension can be applied to the pericardial anchor sutures 280 to tighten the skirt 230 into a ring configuration around the wire frame 222, as shown in FIG. 41 . This completely transforms the pericardial anchor 220 from its straight configuration in the pre-deployment state to its coiled configuration in the post-deployment state.

[0274] During delivery, the pericardial anchor 220 can be constrained in a pre-deployed configuration, such as by an anchor sheath 440, as shown in FIG. 37A. The pericardial anchor 220 can be delivered and positioned within the pericardial space 10 through a delivery subsystem 400, as shown in FIGS. 38-39. Once the pericardial anchor 220 is positioned within the pericardial space 10 and released from the anchor sheath 440, the shape memory of the wire frame 222 causes the pericardial anchor 220 to begin transforming from its elongated pre-deployed configuration to an at least partially coiled configuration. The distal end of the pericardial anchor 220, with the distal eyelet 224 aligned, is released from the anchor sheath 440 first. As shown in FIG. 21, the anchor distal end 225 is the free end of the pericardial anchor 220 and can 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 pericardial anchor 220, preventing it from reaching a fully curved or coiled configuration in the deployed configuration. Then, as the anchor sheath 440 is further retracted from the guidewire sheath 420, the remainder of the pericardial anchor 220 is released from the anchor sheath 440 through the proximal leg 228. The remainder of the pericardial fixation system 200, including the transmyocardial pledget 240 and the anchor socket 260, may then be released from the anchor sheath 440. The pericardial anchor sutures 280 of the pericardial fixation system 200 may then be tensioned, fully coiling the pericardial anchor 220 and tightening the skirt 230 of the pericardial anchor 220. This may convert the pericardial anchor 220 to a fully coiled configuration in the deployed state. The pericardial anchor 220 may then be positioned relative to the epicardial puncture.

[0275] 41 is a cross-sectional view of a heart wall 41 in which a pericardial fixation system 200 has been implanted, according to an embodiment of a method for providing the pericardial fixation system 200. As shown, a fully coiled pericardial anchor 220 can be positioned within the pericardial space 10 and positioned against the epicardial puncture to seal the epicardial puncture. At least a portion of the transmyocardial pledget 240 can fill the endocardium, myocardium, and endocardial puncture. The remainder of the transmyocardial pledget 240 can extend proximally from the epicardial puncture. An anchor socket 260 can extend proximally from the transmyocardial pledget 240. As described below, the remainder of the transmyocardial pledget 240 can be collapsed or folded and positioned against the endocardial puncture to seal the endocardial puncture.

[0276] Leaflet Fixation System According to one embodiment, the pericardial fixation system 200 can be used to control the movement of the mitral valve leaflets by attaching the pericardial anchor sutures 280 to one or more leaflet anchor sutures 310 (also called tethers), which are themselves attached to the mitral valve leaflets 9. After the pericardial anchor 220 is delivered to the target site, the pericardial anchor sutures 280 can be attached to the mitral valve leaflets 9 using a leaflet fixation system 510, as shown in FIG. 52 . The leaflet fixation system 510 includes a leaflet anchor 300 and a leaflet anchor suture 310 operable to couple through the mitral valve leaflet 9 to the leaflet 9. In some embodiments, the leaflet anchor can be delivered to the mitral valve before delivering the pericardial anchor. In some embodiments, the leaflet anchor sutures 310 can be attached to the mitral valve leaflets 9 before the leaflet anchor sutures 310 are attached to the pericardial anchor sutures 280. In some embodiments, the leaflet anchor sutures 310 can be threaded through the mitral valve leaflets 9.

[0277] 42-46 are a series of views of an embodiment of a leaflet fixation system 510 illustrating an embodiment of a method of providing leaflet anchoring using a pericardial fixation system 200 in combination with the leaflet fixation system 510. In some instances, this method of providing leaflet anchoring can be applied multiple times, thereby providing multiple leaflet tethers. In some instances, according to embodiments, the leaflet fixation system 510 can be used to pass the leaflet anchor sutures 310 through the mitral valve leaflets 9 multiple times.

[0278] 42 is a cross-sectional view of a heart 4 showing a delivery subsystem 520 operable with a leaflet fixation system 510, according to an embodiment of a method for providing leaflet anchoring using the pericardial fixation system 200. The delivery subsystem 520 for the leaflet fixation system 510 can be delivered through a delivery catheter 500. The delivery subsystem 520 can be positioned adjacent a first side of the valve leaflet 9, for example, but not limited to, the atrial side of the leaflet 9.

[0279] 43 is a cross-sectional view of the heart 4 illustrating a needle 522 of the valve leaflet fixation system 510, according to one embodiment. The delivery subsystem 520 can deliver the needle 522, which can be positioned adjacent to a first side of the valve leaflet 9. The needle 522 can be extended to puncture through the leaflet 9 and extend from the first side of the leaflet 9 to a second side of the leaflet 9, for example, but not limited to, from the atrial side to the ventricular side of the leaflet 9.

[0280] Leaflet anchor FIG. 44 is a cross-sectional view of the heart 4 illustrating an embodiment of a leaflet anchor 524. The leaflet anchor 524 can be delivered through a needle 522, whereby the leaflet anchor 524 extends from the distal end of the needle 522. In one embodiment, the leaflet fixation 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 FIGS. 23 and 46. According to one embodiment, as shown in FIG. 44, the leaflet anchor 524 is the leaflet anchor 300 coupled to the leaflet anchor suture 310, such as, but not limited to, being integral with or woven through the leaflet anchor 300, extending from the leaflet anchor 300 to the leaflet fixation system 312. Embodiments of the leaflet anchor 524 also include, but are not limited to, knots, stitches, staples, adhesives, and suture clips.

[0281] 45 is a cross-sectional view of a heart 4 with a leaflet anchor 524 according to an embodiment. Tensioning the leaflet anchor sutures 310 can cause the leaflet anchor 524, in this embodiment, the leaflet anchor 300, to collapse or fold against the second side of the valve leaflet 9. The leaflet anchor 300 is operable to clamp into a compressed configuration when tension is applied to the leaflet anchor sutures 310, preventing the leaflet anchor 300 from being pulled out of the puncture in the leaflet 9 extending therefrom. In some embodiments, the leaflet fixation system 312 can include multiple leaflet anchor sutures 310. In some embodiments, each leaflet anchor suture 310 can be individually tensioned. The tension of each leaflet anchor suture 310 can be based on the position of the leaflet anchor relative to the suture lock, as described below. Individualized tensioning of each leaflet anchor suture 310 can help ensure precise and individual control of the motion of various portions of the mitral valve leaflets.

[0282] 46 is a cross-sectional view of the heart 4 with the delivery subsystem 520 of the leaflet fixation system 312 withdrawn. The delivery subsystem 520 can be withdrawn through the delivery catheter 500.

[0283] Once the leaflet fixation system 312 is deployed at the target site on the valve leaflet 9, a suture lock 270 can be provided to lock the leaflet anchor sutures 310 from the pericardial fixation system 200 and from one or more leaflet anchors 524 provided on the valve leaflet 9. Figures 47-49B are a series of views of a method of providing a suture lock according to one embodiment. The suture lock 270 is operable to tie the respective sutures together.

[0284] Suture locking of the valve leaflet sutures to the socket 47 is a cross-sectional view of a heart 4 with a suture lock delivery subsystem 530 operable to deploy a suture lock 270. The suture lock delivery subsystem 530 for the suture lock 270 can be delivered through the delivery catheter distal end 502 of a delivery catheter 500, which in this embodiment, but not by way of limitation, is positioned within the right atrium. The suture lock 270 can be delivered to engage the pericardial anchor suture end 313 from the pericardial anchor suture 280 shown in FIG. 21 , or one or more leaflet anchor sutures 310 from one or more leaflet anchor suture ends 319, as shown in FIG. 23 . The pericardial anchor suture 280 is tensioned to provide a predetermined tension between the pericardial fixation system 200 and the leaflet anchor 524. The suture lock 270 can then be locked to couple the pericardial anchor suture 280 to the suture lock 270 and maintain the desired tension.

[0285] FIG. 48A is a cross-sectional view of a heart 4 with a suture lock 270 positioned within an anchor socket 260 of a pericardial fixation system 200. The suture lock 270 can be positioned within the anchor socket 260 using a pericardial anchor suture 280 as a rail to guide the suture lock 270 into the anchor socket 260. According to one embodiment, a ventricular anchor suture and a leaflet anchor suture are fed through the suture lock, and the ventricular anchor suture is used as a rail to track the suture lock down to the ventricular anchor. The transmyocardial anchor deforms like an accordion during the process of pulling the lock into the heart wall. After a predetermined tension is applied to the leaflet anchor and leaflet function is corrected, the sutures are locked together. According to another embodiment of the method, the anchor suture is tensioned, the transmyocardial anchor pledget is tightened, the leaflet anchor is tensioned, and the sutures are then tied. According to another embodiment, the transmyocardial pledget is tightened, the pericardial fixation system 200 is deployed, the suture lock 270 is deployed, the leaflet anchors are tensioned, and the sutures are then tied. Figure 48B is a cross-sectional view of the heart wall 41 with the suture lock 270 placed in the anchor socket 260 of the pericardial fixation system 200.

[0286] FIG. 49A is a cross-sectional view of a heart 4 with an anchor socket 260 of a pericardial fixation system 200 positioned against a heart wall 41, according to one embodiment. According to one embodiment, the pericardial fixation system 200 does not include an anchor socket 260, and a suture lock 270 is operable to affect tissue ingrowth. FIG. 49B is a cross-sectional view of a heart wall 41 with a pericardial fixation system 200. The suture lock 270 positioned within the anchor socket 260 can be further lowered and positioned against the heart wall 41, causing the excess length of the transmyocardial pledget 240 to fold or collapse down onto the heart wall 41. The suture lock 270 positioned within the anchor socket 260 can be positioned against the folded portion of the transmyocardial pledget 240. The suture lock 270 enclosed within the anchor socket 260 can press the anchor socket 260 into the endocardial surface, which can also facilitate sealing of the puncture at the endocardial surface by 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 can then be withdrawn through the delivery catheter 500.

[0287] Suture cutter Once the suture lock 270 is delivered to the target site within the anchor socket 260, a suture cutter 542 can be provided to cut the suture ends of one or more leaflet anchor sutures 310 and 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 the suture cutter 542. The delivery subsystem 540 can be provided and delivered through the 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 be railed down over the sutures 280, 310 toward the suture lock 270. The suture cutter 542 can cut off the excess suture ends of the sutures 280, 310 after the sutures 280, 310 have been 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 through the delivery catheter 500 and from the heart. 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.

[0288] 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 valve leaflets 9. Each of the multiple leaflet anchors 524 can have a leaflet anchor suture 310 connected to a pericardial fixation system 200 as described herein.

[0289] In accordance with other embodiments, the present disclosure relates to apparatus, systems, and methods for placing hardware, devices, or therapeutic procedures into the pericardial space from the ventricular side of the heart. While the present disclosure discusses embodiments herein with respect to intravascular locations and ventricles of a patient, the embodiments are applicable to placement into the pericardial space from many approaches, including improvements over current methods performed percutaneously from outside the chest or abdomen.

[0290] tool The tools of the present disclosure, when used to place a device or therapeutic procedure within the pericardial space, can be performed using echocardiography and / or fluoroscopy, and the deployment of the tools and their use can be permanent or reversible.

[0291] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of some embodiments. However, those 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.

[0292] The present disclosure relates to systems and methods for placing hardware, devices, or therapeutic procedures into the pericardial space from a ventricle of the heart using an endovascular approach. This placement may be necessary when a therapeutic procedure is needed 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, referred to herein as a tool, is provided that is operable to be deployed within the myocardium and extend from the ventricular side of the heart into the pericardial space. These embodiments allow for crossing of the myocardium while minimizing the risk or extent of myocardial damage, bleeding, or improper placement.

[0293] 54A and 54B are side and cross-sectional views, respectively, of tool 150, according to an embodiment. Embodiments of 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, although larger or smaller versions of the same components may be used depending on the intended application. According to one embodiment, tool 150 includes a body 170 and a head 160, where body 170 is operable to be deployed within the myocardium and head 160 is operable to extend from the myocardium into the pericardial space 10. According to one embodiment, 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 tool 150. According to one embodiment, these movable elements are operable to secure tool 150 within the pericardial space 10 after deployment. 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 ventricle 22 and 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 operable to provide fluid communication between ventricle 22 and pericardial cavity 10 is operable to facilitate confirmation of placement of tool 150 in pericardial cavity 10 as well as to facilitate passage of a wire, catheter, or device from the ventricular side of heart 2 to pericardial cavity 10.

[0294] According to one embodiment, access channel 176 can include an occlusion element 175 operable to occlude or stop fluid communication through access channel 176. According to one embodiment, eyelet 174 includes a resilient material operable to open under the force of an object or fluid or gas pressure passing through lumen 172, and to close fluid communication with lumen 172 in the absence of object, fluid, or gas pressure at eyelet 174. In another embodiment, eyelet 174 further includes a flap operable to open under the force of an object or fluid or gas pressure at eyelet 174, and to close fluid communication with lumen 172 in the absence of object, fluid, or gas pressure at eyelet 174.

[0295] According to one embodiment, movable member 161 can be an anchor extension member 162 and / or an anchor apposition member 164.

[0296] Anchor extension member 162 is operable to provide a graduated transverse profile in the pre-deployment configuration and to support the parietal pericardium when anchor extension member 162 is expanded or moved to the post-deployment configuration.

[0297] Anchor apposition member 164 is operable to provide a graduated transverse profile in a pre-deployment configuration and is operable to support against visceral pericardium 19 when anchor apposition member 164 is expanded or moved to a post-deployment configuration within pericardial space 10. According to 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.

[0298] Body 170 is operable to occupy transverse segment 28 to maintain hemostasis after transecting the myocardium. As described below, heart wall 4 is punctured by needle 56 and / or tool 150 from the ventricle side to the pericardial cavity 10 side while tool 150 is deployed. The heart wall channel drilled or formed in heart wall 4 is referred to herein as transverse segment 28.

[0299] Tool 150 further includes a retention element 180 operable to hold tool 150 within heart wall 4 and / or as a means for coupling to other treatment devices. According to one embodiment, retention element 180 is a biocompatible chordae tendineae or similar member to which a treatment device (e.g., valve repair, heart failure repair, or replacement prosthesis) can be coupled.

[0300] 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 and move movable members 161 to a post-deployment configuration once head 160 is positioned at a desired location. These movable members 161, according to one embodiment, are operable to act as anchors after deployment.

[0301] 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 accept a delivery catheter 55 operable to position and deploy the tool 150 with the body 170 within the heart wall 4 and the head 160 extending therefrom 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 transvenously, transseptally, through the mitral valve into the left ventricle 22, and subsequently via 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 therapeutic, as shown in FIG. 54D. FIG. 54D is a cross-sectional view of the left ventricle 22 showing the distal end 52 of the delivery catheter. The delivery catheter system 50 may be in a single, in-line, or telescopic configuration. While the figures show a transvenous, transseptal approach, the delivery catheter system 50 and tool 150 may be used in a transatrial or transaortic approach as well. Similarly, the delivery catheter system 50 may be inserted into the pericardial space 10 from either atrium and either ventricle 22.

[0302] According to one embodiment, 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. Needle 56 can be coupled or integrated with guidewire 54, as shown in FIG. 55B, which can be advanced into pericardial space 10 after puncturing the visceral pericardium 19, thereby facilitating subsequent catheter exchanges.

[0303] Figures 55A-55I illustrate a delivery procedure for a tool 150 using a delivery catheter system 50 according to one embodiment. Figure 55A is a cross-sectional view of a heart 2 showing a delivery catheter system 50 positioned adjacent to the endocardium 11 according to one embodiment. As shown in Figure 55A, a steerable guide catheter 55 is steered to the target site and against the surface of the endocardium 11. A trajectory is established by steering the different steerable catheters 51, 53, 55 while confirming with echocardiography, fluoroscopy, or other equivalent imaging modality.

[0304] The tool 150 is then advanced through the myocardium 13. FIG. 55B is a cross-sectional view of the heart 2 illustrating the placement of the tool 150 into the myocardium 13 and pericardial cavity 10, piercing the endocardium 11 and myocardium 13 with the aid of the needle 56 during the deployment process, according to one embodiment. This advancement can be assisted by the needle 56 as well as electrical energy, cryoablation, radiofrequency, or mechanical force. In at least one embodiment, the tool 150 employs a mechanical method of traversing the myocardium with a stylet using the needle 56 to reduce tissue coring. In at least one other embodiment, the tool 150 uses radiofrequency energy or cauterization. In at least one other embodiment, the tool 150, with or without a support needle 56 or guidewire 54, has a beveled or non-beveled sharp end to facilitate traversal. In at least one other embodiment, rotating the tool 150 facilitates traversal of the myocardium. These embodiments enable traversal of the myocardium while minimizing the risk or extent of myocardial damage, bleeding, or improper placement. The tool 150 is advanced to the visceral pericardium 19 and gently transected.

[0305] 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 an 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 rigid compliance of the parietal pericardial layer, and the potential space between the visceral pericardium 19 and the parietal layer. In at least one embodiment, a signal from the eyelet 174, such as, but not limited to, hydrostatic pressure or electrical impedance, is monitored to determine when the visceral pericardium 19 has been traversed and the head 160 of the tool 150 is within the pericardial cavity 10. FIG. 55D is a cross-sectional view of the heart 2 showing the tool 150 expanding the pericardial cavity 10 during the deployment process, according to one embodiment. According to one embodiment, position verification can also be performed by injecting a contrast or imaging agent, as shown in FIG. 55D. Injection of these substances allows the pericardial space 10 to expand as the tool 150 is advanced.

[0306] In some embodiments, the eyelet 174 facilitates confirmation of placement in the pericardial space 10 and the passage of wires, catheters, or devices into the pericardial space 10. The eyelet 174 can be used to deliver contrast or visualization agents as well as to transduce fluid or wall pressure. The eyelet 174 can also be used to inject and expand the pericardial space 10 with material (e.g., gas, fluid, or mechanical dilators) to facilitate subsequent device placement. In at least one embodiment, the eyelet 174 is located at the distal end of the tool 150 and faces the pericardial space 10 in an orthogonal, perpendicular, or oblique orientation relative to the pericardial surface. In at least one embodiment, the eyelet 174 can be positioned more proximally on the head 160 of the tool 150 or along the length of the head 160. In other embodiments, the eyelet 174 can be oval, circular, square, rectangular, or other geometric shapes and sizes. In other embodiments, there can be multiple eyelets 174 , some or all of which are in fluid communication with one or more lumens 172 within body 170 .

[0307] 55E is a cross-sectional view of heart 2 showing the movable elements of tool 150 enlarging pericardial space 10 during the deployment process, according to one embodiment. As shown in FIG. 55E, once tool 150 is advanced into pericardial space 10, anchor extension members 162 are released, according to an embodiment, by retraction of a retaining cable or similar element or by sheathing release. These anchor extension members 162 are operable to generate a force to push against the blunter and parietal pericardial layer to expand pericardial space 10. This expansion allows larger elements to be advanced into pericardial space 10, if desired.

[0308] In some embodiments, tool 150 includes movable elements that assist in expanding pericardial space 10 as tool 150 is advanced. In at least one embodiment, head 160 defines these movable elements to be located 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.

[0309] FIG. 55F is a cross-sectional view of heart 2 illustrating the movable elements of tool 150 engaging the epicardium 14 and / or pericardium 18 to secure tool 150 in the pericardial cavity 10, according to one embodiment. As shown in FIG. 55F, anchor expansion member 162 can expand or contract as tool 150 is advanced to create additional space within pericardial cavity 10. Once head 160 of tool 150 is positioned within pericardial cavity 10, anchor apposition member 164 is expanded or deployed, as shown in FIG. 55G. FIG. 55G is a cross-sectional view of heart 2 illustrating the movable elements of tool 150 engaging the epicardium 14 and / or pericardium 18 to secure tool 150 in the pericardial cavity 10, according to one embodiment. Head 160 of tool 150, including the movable elements, can be retracted, rotated, or recaptured to position it 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 member 161 (in this embodiment, expanded anchor apposition member 164 and anchor extension member 162) in a deployed configuration, according to one embodiment.

[0310] Once properly positioned, pericardial anchor tool 150 is removed from delivery catheter system 50. Tool 150 is retained by cooperative engagement of retaining element 180 with head 160 of tool 150, so that tool 150 remains within the myocardium and is extended into pericardial space 10 for use. According to one embodiment, eyelet 174 can be closed by occlusion element 175 to prevent fluid communication between ventricle 22 and pericardial space 10.

[0311] 56A1-56D2 show different configurations of anchor extension members 162 and anchor apposition members 164. These can be symmetrical, asymmetrical, different lengths, concave or convex, different pads and sizes, offset or perpendicular.

[0312] In some embodiments, similar methods described herein for accessing the pericardial cavity 10 using tool 150 can also be used to place devices, anchors, or therapeutic means on the surface of the parietal pericardium.

[0313] The inventive features of the present disclosure have been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various changes and modifications can be made to the embodiments without departing from the scope of the present disclosure. Therefore, 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.

Claims

1. Anchor, and a tether coupled to the anchor; A fastening system comprising: The anchor is operable to have a low profile in a first position and a larger profile in a second position, and the anchor is 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 expand within the pericardial cavity to the second position to a size larger than the narrow access channel.

2. the anchor is a wire having a first wire end and a second wire end, the wire having a shape memory property configured into a ring-like configuration, the first wire end opposing the second wire end; a skirt coupled to the wire along an edge defining a length thereof; and a plurality of apertures along an edge of the skirt opposite the wire; the tether is interwoven through the plurality of apertures, the tether defining a first tether end and a second tether end; and 2. The anchoring system of claim 1, wherein the first end of the tether and the second end of the tether are operable to be tensioned to pinch the skirt into a disk-shaped shape when the wire is in a ring-shaped configuration in a post-deployment configuration, and wherein 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-deployment configuration.

3. The fixation system of claim 2 , wherein the first end of the wire and the second end of the wire are operable to be fixedly coupled to one another when in the ring-shaped configuration.

4. 3. The fixation system of claim 2, wherein the first end of the wire and the second end of the wire are operable to engage when in the ringed configuration to prevent the first end of the wire and the second end of the wire from overlapping beyond a complete loop of the wire.

5. The fixation system of claim 2 , wherein the skirt has tissue ingrowth properties on one side and tissue anti-adhesion properties on the other side.

6. 3. The fixation system of claim 2, further comprising a tether lock slidably coupled to the tether, the tether lock sliding along the tether to lock it in place, the tether lock operable to capture tissue between the tether lock and the anchor.

7. The anchoring system of claim 6 , further comprising a tether lock nesting element slidably coupled to the tether and operable to slide along the tether to accommodate the tether.

8. Providing a fastening system according to any one of claims 2 to 7, advancing a guidewire into the femoral vein; advancing the guidewire through the femoral vein 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 into the myocardium; advancing the guidewire through the needle catheter, through the myocardium and epicardium, and into the pericardial space; withdrawing the needle catheter from the guidewire; advancing a catheter over the guidewire into the pericardial space; Inflate the pericardium and separate it from the heart wall, enlarging the pericardial cavity; advancing the fixation system either over the guidewire or through the catheter to place the anchor within the pericardial space; deploying an anchor of the fixation system within the pericardial space and positioning the anchor against the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration due to tension on the first end of the tether and the second end of the tether, and in a ring-shaped configuration in a post-deployment configuration due to tension on the first end of the tether and the second end of the tether; removing the guidewire and / or the catheter from the patient, leaving the tether coupled to the anchor within the heart chamber; a fixing method,

9. Providing a fastening system according to any one of claims 2 to 7, advancing the guidewire into the needle catheter so that the distal end of the guidewire is adjacent the distal end of the needle catheter; advancing the distal end of the needle catheter from the heart chamber through the endocardium of the heart wall into the myocardium; advancing the distal end of the guidewire through the myocardium and epicardium into the pericardial space; and 、 advancing an anchor of the fixation system over the guidewire into the pericardial space; deploying the anchor within the pericardial space, wherein the anchor is in a straight configuration due to tension on the first end of the tether and the second end of the tether in a pre-deployment configuration and in a ring-shaped configuration due to tension on the first end of the tether and the second end of the tether in a post-deployment configuration; a fixing method,

10. Providing a fastening system according to any one of claims 2 to 7, advancing the support catheter into the heart, up to, adjacent to, or against the wall of the heart; advancing an anchor catheter alone or through the support catheter to engage it against the heart wall; advancing a guidewire along or through the anchoring catheter through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing the anchoring catheter along or over the guidewire through the endocardium, myocardium, and epicardium (visceral layer of the serous pericardium) of the heart wall into the pericardial space; advancing or exposing an anchor of the fixation system through or at the distal end of the anchor catheter within the pericardial space, wherein the anchor is disposed within the pericardial space; deploying an anchor of the fixation system within the pericardial space and positioning the anchor against the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration due to tension on the first end of the tether and the second end of the tether, and in a ring-shaped configuration in a post-deployment 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 within the heart chamber; a fixing method,

11. Providing a fastening system according to any one of claims 2 to 7, advancing the anchoring catheter within the heart chamber to and against the heart wall; advancing a guidewire through the anchor catheter such that a distal end of the guidewire is advanced through the endocardium, into the myocardium, and through the epicardium into the pericardial space; advancing the distal end of the anchor catheter along or over the guidewire into or adjacent to the pericardial space; advancing or exposing an anchor of the fixation system through or at the distal end of the anchor catheter within the pericardial space, wherein the anchor is disposed within the pericardial space; deploying an anchor of the fixation system within the pericardial space and positioning the anchor against the epicardium, wherein the anchor is in a straight configuration in a pre-deployment configuration due to tension on the first end of the tether and the second end of the tether, and in a ring-shaped configuration in a post-deployment configuration due to tension on the first end of the tether and the second end of the tether; removing the guidewire and the anchor catheter from the patient, leaving a tether on the guidewire and in the pericardial space coupled to the anchor within the cardiac chamber of the fixation system; a fixing method,

12. a pericardial anchor including a skirt; Transmyocardial pledget, a pericardial anchor suture coupled to the pericardial anchor and the transmyocardial pledget; Suture lock, and an anchor socket configured to restrain and dock said suture lock; a pericardial fixation system, comprising: at least one leaflet anchor coupled to the leaflet anchor suture; 1. A mitral valve chordae repair system comprising: the pericardial anchor is configured to be transformable between a pre-deployment configuration and a post-deployment configuration; The suture lock is configured to secure the pericardial anchor suture and the leaflet anchor suture.

13. The mitral valve chordae repair system of claim 12 , wherein the pericardial anchor is configured to form a disk shape in the deployed configuration.

14. The mitral valve chordae repair system of claim 12 , wherein the pericardial anchor is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployed configuration.

15. The mitral valve chordae repair system of claim 12 , wherein the pre-deployed configuration comprises an elongated configuration and the post-deployed configuration comprises a compressed configuration.

16. The mitral valve chordae repair system of claim 12 , wherein the pre-deployment configuration comprises an elongated configuration and the post-deployment configuration comprises a coiled configuration.

17. 13. The mitral valve chordae repair system of claim 12, wherein the pericardial anchor has a free end in the pre-deployed configuration, and the pericardial anchor is configured to be coiled starting from the free end of the pericardial anchor to form the deployed configuration.

18. The mitral valve chordae repair system of claim 12 , wherein the pericardial anchor further comprises a wire frame, the wire frame being covered by the skirt.

19. The mitral valve chordae repair system of claim 18 , wherein the wire frame of the pericardial anchor has shape-memory properties that are configured into the deployed configuration.

20. 20. The mitral valve chordae repair system of claim 18, wherein the skirt is configured to slidingly receive a pericardial anchor suture, the pericardial anchor suture being operable to be tensioned to tighten the skirt into the deployed configuration.

21. 19. The mitral valve chordae repair system of claim 18, wherein the skirt of the pericardial 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 into a deployed configuration.

22. 20. The mitral valve chordae repair system of claim 18, wherein the wire frame of the pericardial anchor further comprises proximal legs, the proximal legs configured to remain straight and centered within the pericardial anchor in the deployed configuration.

23. 23. The mitral valve chordae repair system of claim 22, wherein the transmyocardial pledget extends from a proximal leg of the pericardial anchor.

24. 23. The mitral valve chordae repair system of claim 22, wherein the proximal leg comprises two sections of the same wire folded twice over, the two sections being parallel to one another.

25. The mitral valve chordae repair system of claim 12 , wherein the pericardial anchor is transformable between a pre-deployment configuration and a post-deployment configuration, at least in part, by proximal retraction of the pericardial anchor suture.

26. 20. The mitral valve chordae repair system of claim 18, wherein the pericardial anchor is transformable between the pre-deployment configuration and the post-deployment configuration at least in part by a shape-memory property of a wire frame shaped to the post-deployment configuration.

27. The mitral valve chordae repair system of claim 18 , wherein the first end of the wire frame and the second end of the wire frame each comprise an atraumatic end.

28. The mitral valve chordae repair system of claim 12 , wherein the transmyocardial pledget comprises a film having a tubular structure.

29. 30. The mitral valve chordae repair system of claim 28, wherein the pericardial anchor sutures are woven through a plurality of apertures that penetrate the transmyocardial pledget film.

30. The mitral valve chordae repair system of claim 12 , wherein the anchor socket comprises a film-covered self-expanding frame.

31. a pericardial anchor including a skirt; a transmyocardial pledget extending from a proximal portion of the pericardial anchor; a pericardial anchor suture coupled to the pericardial anchor and the 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 fixation system comprising: The pericardial fixation system, wherein the pericardial anchor is configured to be transformable between a pre-deployment configuration and a post-deployment configuration.

32. 32. The pericardial fixation system of claim 31 , wherein the pericardial anchor is configured to form a disk shape in a deployed configuration.

33. 32. The pericardial fixation system of claim 31, wherein the pericardial anchor is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployed configuration.

34. 32. The pericardial fixation system of claim 31, wherein the pre-deployed configuration comprises an elongated configuration and the post-deployed configuration comprises a compressed configuration.

35. 32. The pericardial fixation system of claim 31, wherein the pre-deployment configuration comprises an elongated configuration and the post-deployment configuration comprises a coiled configuration.

36. 32. The pericardial fixation system of claim 31 , wherein the pericardial anchor has a free end in the pre-deployed configuration, and the pericardial anchor is configured to be coiled starting from the free end of the pericardial anchor to form the deployed configuration.

37. 32. The pericardial fixation system of claim 31, wherein the pericardial anchor further comprises a wire frame, the wire frame being covered by a skirt.

38. 38. The pericardial fixation system of claim 37, wherein the wire frame of the pericardial anchor has shape memory properties that are shaped to a post-deployment configuration.

39. 32. The pericardial fixation system of claim 31 , wherein the skirt is configured to slidingly receive a pericardial anchor suture, the pericardial anchor suture operable to be tensioned to tighten the skirt in a deployed configuration.

40. 38. The pericardial fixation system of claim 37, wherein a skirt of the pericardial 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, the pericardial anchor sutures being operable to be tensioned to tighten the skirt in the deployed configuration.

41. 38. The pericardial fixation system of claim 37, wherein the wire frame of the pericardial anchor includes proximal legs configured to remain straight and centered within the pericardial anchor in the deployed configuration.

42. 42. The pericardial fixation system of claim 41, wherein the transmyocardial pledget extends from a proximal leg of the pericardial anchor.

43. 42. The pericardial fixation system of claim 41, wherein the proximal leg comprises two sections of the same wire folded in half, the two sections being parallel to one another.

44. 32. The pericardial fixation system of claim 31, wherein the pericardial anchor is transformable between the pre-deployment configuration and the post-deployment configuration, at least in part, by proximal retraction of the pericardial anchor suture.

45. 38. The pericardial fixation system of claim 37, wherein the pericardial anchor is transformable between the pre-deployment configuration and the post-deployment configuration at least in part due to a shape memory property of a wire frame shaped to the post-deployment configuration.

46. 38. The pericardial fixation system of claim 37, wherein the first end of the wire frame and the second end of the wire frame each comprise an atraumatic end.

47. 47. The pericardial fixation system of claim 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.

48. 32. The pericardial fixation system of claim 31, wherein the transmyocardial pledget comprises a film having a tubular structure.

49. 49. The pericardial fixation system of claim 48, wherein the pericardial anchor sutures are woven through a plurality of apertures that penetrate the film of the transmyocardial pledget.

50. Skirt, and a pericardial anchor suture coupled to the skirt; 1. A pericardial anchor comprising: a pericardial anchor configured to be deformable between a pre-deployment configuration and a post-deployment configuration.

51. 51. The pericardial anchor of claim 50, wherein the pericardial anchor is configured to form a disk shape in the deployed configuration.

52. 51. The pericardial anchor of claim 50, wherein the pericardial anchor is configured to form a curved shape, a compressed shape, a bundle, a mass, or a knot in the deployed configuration.

53. 51. The pericardial anchor of claim 50, wherein the pre-deployed configuration comprises an elongated configuration and the post-deployed configuration comprises a compressed configuration.

54. 51. The pericardial anchor of claim 50, wherein the pre-deployed configuration comprises an elongated configuration and the post-deployed configuration comprises a coiled configuration.

55. 51. The pericardial anchor of claim 50, wherein the pericardial anchor has a free end in the pre-deployed configuration, and the pericardial anchor is configured to be coiled starting from the free end of the pericardial anchor to form the deployed configuration.

56. 51. The pericardial anchor of claim 50, further comprising a wire frame, the wire frame being covered by the skirt.

57. 57. The pericardial anchor of claim 56, wherein the wire frame of the pericardial anchor has shape memory properties that are configured into the deployed configuration.

58. 57. The pericardial anchor of claim 56, wherein the skirt is configured to slidingly receive the pericardial anchor suture, the pericardial anchor suture being operable to be tensioned to tighten the skirt in the deployed configuration.

59. 57. The pericardial anchor of claim 56, wherein a skirt of the pericardial 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 the deployed configuration.

60. 57. The pericardial anchor of claim 56, wherein the wire frame of the pericardial anchor further comprises proximal legs configured to remain straight and centered within the pericardial anchor in the deployed configuration.

61. 61. The pericardial anchor of claim 60, wherein the proximal leg comprises two portions of the same wire folded in half, the two portions being parallel to one another.

62. 61. The pericardial anchor of claim 60, wherein the pericardial anchor is transformable between the pre-deployment configuration and the post-deployment configuration, at least in part, by proximal retraction of the pericardial anchor suture.

63. 57. The pericardial anchor of claim 56, wherein the pericardial anchor is transformable between the pre-deployment configuration and the post-deployment configuration at least in part due to a shape memory property of the wire frame configured to the post-deployment configuration.

64. 57. The pericardial anchor of claim 56, wherein the first end of the wire frame and the second end of the wire frame each comprise an atraumatic end.

65. 65. The pericardial anchor of claim 64, 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.

66. advancing a pericardial anchor in a pre-deployed configuration constrained within an anchor catheter into the pericardial cavity of the heart; advancing the anchor catheter tangentially within the pericardial space a predetermined distance to unsheath the pericardial anchor in the pre-deployed configuration; and retracting the anchor catheter to at least partially deploy a pericardial anchor to a deployed configuration within the pericardial space; 10. A method for securing a pericardial fixation system, comprising:

67. 67. The method of claim 66, wherein the predetermined distance is at least 10 cm.

68. 67. The method of claim 66, wherein the anchoring catheter is configured to move in a medial-lateral and / or inferior-superior direction within the pericardial space.

69. 67. The method of claim 66, further comprising positioning a proximal leg of the pericardial anchor between the epicardium and the distal tip of the anchor catheter to maintain the position of the pericardial anchor within the pericardial space.

70. 67. The method of claim 66, further comprising applying tension to pericardial anchor sutures of the pericardial fixation system to at least partially deform the pericardial anchors to the deployed configuration.

71. 67. The method of claim 66, wherein the pericardial anchor is further deformed to the deployed configuration at least in part by a shape memory property of a wire frame of the pericardial anchor that is shaped to the deployed configuration.

72. advancing a support sheath within the heart chamber to and against the heart wall; advancing a guidewire through the support sheath such that the 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; retracting the anchor sheath and the support sheath together while maintaining the position of the guidewire sheath to deploy a pericardial anchor of a pericardial fixation system within the pericardial space, wherein the pericardial anchor is in a pre-deployed configuration while disposed within the anchor sheath. retracting the guidewire sheath while maintaining the position of the anchor sheath to form a T-bar between the proximal leg of the wire frame of the pericardial anchor and the 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 pericardial anchor; and applying tension to a pericardial anchor suture of the pericardial fixation system to at least partially deform said pericardial anchor to a post-deployment configuration; 10. A method for securing a pericardial fixation system, comprising:

73. 73. The method of fixation of a pericardial fixation system of claim 72, wherein the pericardial anchor is further deformed to the deployed configuration at least in part by a shape memory property of the wire frame shaped to the deployed configuration.

74. 73. The method of fixating a pericardial fixation system of claim 72, further comprising maintaining the position of the guidewire sheath, retracting the support sheath and the anchor sheath, and deploying a transmyocardial pledget and anchor socket of the pericardial fixation 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.

75. 75. The method of fixating a pericardial fixation system of claim 74, further comprising folding a second portion of the transmyocardial pledget against the endocardial puncture.

76. 75. The method of fixating a pericardial fixation system of claim 74, further comprising advancing a suture lock into the anchor socket and advancing the suture lock disposed in the anchor socket toward the endocardium to collapse a second portion of the transmyocardial pledget.

77. 76. The method of securing a pericardial fixation system of claim 75, wherein the film-covered proximal leg of the pericardial anchor is configured to seal the epicardial puncture, the first portion of the transmyocardial pledget is configured to seal the myocardial puncture, and the folded second portion of the transmyocardial pledget is configured to seal the endocardial puncture.

78. 1. A tool for placement in the heart wall and pericardial space, operable to provide access to the pericardial space from a cardiac chamber and / or operable to anchor a device coupled to the pericardial space, comprising: a body defining a lumen operable to extend through the heart wall; a head located at a distal end of the body and operable to extend into the pericardial cavity; and a base including a retention member operable to retain the base against the heart wall; A tool comprising: The tool, wherein the head includes a movable element operable to move from a low-profile pre-deployment configuration to a high-profile post-deployment configuration, and the head defines an eyelet in fluid communication with a lumen, thereby defining an access channel operable to provide a fluid passageway between the cardiac chamber and the pericardial space.

79. 79. The tool of claim 78, wherein the movable element is operable to reinforce the parietal pericardium when the movable element reaches a high profile in a deployed configuration, and the retaining member cooperates to abut and engage the movable element against the parietal pericardium.

80. 80. The tool of claims 78 and 79, wherein the movable element includes an expansion member operable to abut the parietal pericardium and enlarge the pericardial cavity.

81. 80. The tool of claims 78 and 79, wherein the eyelet is operable to evacuate or remove fluid or gas from the pericardial space with a device in communication with the lumen.

82. 79. The tool of claim 78, wherein the eyelet is operable as a pressure port operable to measure pressure with a pressure sensing device.

83. 83. The tool of any one of claims 78 to 82, wherein the access channel is operable to receive and pass a device between the ventricular side of the heart and the pericardial space.

84. 83. A tool according to any one of claims 78 to 82, wherein 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 and the passage of fluid therethrough is prevented.

85. 83. A tool according to any one of claims 78 to 82, wherein the head further comprises an obstruction element operable to elastically deform between an open position and a closed position, wherein in the closed position the access channel is obstructed and the passage of fluid therethrough is prevented.

86. 83. The tool of any one of claims 78 to 82, further comprising an occlusion plug operable for placement within the access channel to occlude the access channel and prevent the passage of fluid therethrough.

87. The tool of any one of claims 78 to 83, wherein the tool is operable to couple with other devices or cardiac tissue.

88. 88. A method for implanting a tool according to any one of claims 78 to 87, said method comprising: 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 attached thereto into the myocardium so that the head of the tool extends into the pericardial space; A method comprising:

89. The delivery system further comprises a guidewire and / or a needle, and the method further comprises:

90. The method of claim 88, comprising advancing the 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.

90. placing a suture lock within the anchor socket; connecting a pericardial anchor suture integral with the pericardial anchor and at least one leaflet anchor suture integral with the at least one leaflet anchor to the suture lock; locking the pericardial anchor suture to the suture lock; applying a predetermined tension to each of the at least one leaflet anchor suture individually based on a position of the suture lock for each of the at least one leaflet anchor suture; and locking the at least one leaflet anchor suture; 1. A method for repairing a mitral valve annulus, comprising:

91. 91. The method of claim 90, further comprising compressing the at least one leaflet anchor to connect the mitral valve leaflets.

92. at least one leaflet anchor configured to pass through the mitral valve leaflet; and at least one leaflet suture integral with the at least one leaflet anchor and configured to pass through the mitral valve leaflet; providing a leaflet fixation system comprising: advancing the delivery catheter to a first side of the mitral valve leaflet; advancing a needle through the delivery catheter; Extending the needle to puncture the mitral valve leaflet; delivering at least one leaflet anchor integrated with the at least one leaflet suture to a second side of the mitral valve leaflet; tensioning the at least one leaflet suture individually to a predetermined tension based on the position of the suture lock; and removing the delivery catheter; A method for fixing a valve leaflet, comprising:

93. 93. The method of claim 92, further comprising locking the at least one leaflet suture with a suture lock to maintain tension on the at least one leaflet suture.

94. 93. The method of claim 92, wherein the at least one leaflet anchor is a pledget including at least one aperture configured to mate with the at least one leaflet suture.

95. 93. The method of claim 92, wherein the at least one leaflet anchor is configured to form a compressed configuration when tension is applied to the at least one leaflet suture.

96. 93. The method of claim 92, further comprising compressing the at least one leaflet anchor by applying tension to the at least one leaflet suture.

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